UNITEDSTATES

SECURITIESAND EXCHANGE COMMISSION

Washington,D.C. 20549

FORM10-Q

☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Forthe quarterly period ended June 30, 2025

☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commissionfile number: 001-39717

LIXTEBIOTECHNOLOGY HOLDINGS, INC.

(Exactname of registrant as specified in its charter)

Delaware		20-2903526
(State or other jurisdiction of		(I.R.S. Employer
incorporation or organization)		Identification Number)

680East Colorado Boulevard, Suite 180

Pasadena,California 91101

(Addressof principal executive offices, including Zip Code)

(631)830-7092

(Registrant’stelephone number, including area code)

Securitiesregistered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.0001 per share	LIXT	The Nasdaq Stock Market LLC
Warrants to Purchase Common Stock, par value $0.0001 per share	LIXTW	The Nasdaq Stock Market LLC

Indicateby check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities ExchangeAct of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)has been subject to such filing requirements for the past 90 days.

Yes☒ No ☐

Indicateby check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrantwas required to submit such files).

Yes☒ No ☐

Indicateby check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reportingcompany, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”,“smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐	Accelerated filer ☐
Non-accelerated filer ☒	Smaller reporting company ☒
	Emerging growth company ☐

Ifan emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complyingwith any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicateby check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes☐ No ☒

Asof August 5, 2025, the Company had 4,561,363 shares of common stock issued and outstanding.

LIXTEBIOTECHNOLOGY HOLDINGS, INC.

ANDSUBSIDIARY

TABLEOF CONTENTS

	Page Number

PART I - FINANCIAL INFORMATION	3

Item 1. Condensed Consolidated Financial Statements	3

Condensed Consolidated Balance Sheets – June 30, 2025 (Unaudited) and December 31, 2024	3

Condensed Consolidated Statements of Operations (Unaudited) – Three Months and Six Months Ended June 30, 2025 and 2024	4

Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) – Three Months and Six Months Ended June 30, 2025 and 2024	5

Condensed Consolidated Statements of Cash Flows (Unaudited) – Six Months Ended June 30, 2025 and 2024	7

Notes to Condensed Consolidated Financial Statements (Unaudited) – Three Months and Six Months Ended June 30, 2025 and 2024	8

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations	43

Item 3. Quantitative and Qualitative Disclosures About Market Risk	65

Item 4. Controls and Procedures	65

PART II - OTHER INFORMATION	66

Item 1. Legal Proceedings	66

Item 1A. Risk Factors	66

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	66

Item 3. Defaults Upon Senior Securities	66

Item 4. Mine Safety Disclosures	66

Item 5. Other Information	66

Item 6. Exhibits	67

SIGNATURES	68

PARTI - FINANCIAL INFORMATION

ITEM1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

LIXTEBIOTECHNOLOGY HOLDINGS, INC.

ANDSUBSIDIARY

CONDENSEDCONSOLIDATED BALANCE SHEETS

	June 30, 2025			December 31, 2024
		(Unaudited)

ASSETS
Current assets:
Cash	$	887,212		$	1,038,952
Prepaid insurance		14,597			20,898
Other prepaid expenses		87,943			85,653
Total current assets		989,752			1,145,503
Deferred offering costs		198,826			—
Total assets	$	1,188,578		$	1,145,503

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued expenses, including $10,000 and $27,500 to related parties at June 30, 2025 and December 31, 2024, respectively	$	92,149		$	83,206
Research and development contract liabilities		256,147			235,078
Accrued offering costs		188,826			—
Total current liabilities		537,122			318,284

Commitments and contingencies		-			-

Stockholders’ equity:
Preferred Stock, $0.0001 par value; authorized – 10,000,000 shares; issued and outstanding –0 350,000 shares of Series A Convertible Preferred Stock, $10.00 per share stated value, convertible into0 72,917 shares of common stock		—			3,500,000
Common stock, $0.0001 par value; authorized – 100,000,000 shares; issued and outstanding – 2,756,991 shares and 2,249,290 shares at June 30, 2025 and December 31, 2024, respectively		276			225
Additional paid-in capital		54,204,101			49,394,687
Accumulated deficit		(53,552,921	)		(52,067,693	)
Total stockholders’ equity		651,456			827,219
Total liabilities and stockholders’ equity	$	1,188,578		$	1,145,503

Seeaccompanying notes to condensed consolidated financial statements.

LIXTEBIOTECHNOLOGY HOLDINGS, INC.

ANDSUBSIDIARY

CONDENSEDCONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

	2025			2024			2025			2024
	Three Months Ended						Six Months Ended
	June 30,						June 30,
	2025			2024			2025			2024

Revenues	$	—		$	—		$	—		$	—

Costs and expenses:
Research and development costs		60,648			210,708			152,105			329,772
General and administrative costs		714,161			798,448			1,329,644			1,646,263
Total costs and expenses		774,809			1,009,156			1,481,749			1,976,035
Loss from operations		(774,809	)		(1,009,156	)		(1,481,749	)		(1,976,035	)
Interest income		365			2,233			806			5,092
Interest expense		(1,810	)		(4,154	)		(4,945	)		(11,340	)
Foreign currency gain		581			158			660			42
Net loss	$	(775,673	)	$	(1,010,919	)	$	(1,485,228	)	$	(1,982,241	)

Net loss per common share – basic and diluted	$	(0.29	)	$	(0.45	)	$	(0.57	)	$	(0.88	)

Weighted average common shares outstanding – basic and diluted		2,720,533			2,249,290			2,596,509			2,249,290

Seeaccompanying notes to condensed consolidated financial statements.

LIXTEBIOTECHNOLOGY HOLDINGS, INC.

ANDSUBSIDIARY

CONDENSEDCONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)

ThreeMonths and Six Months Ended June 30, 2025 and 2024

	Shares			Amount			Shares		Par Value		Paid-in Capital		Accumulated Deficit			Stockholders’ Equity
	Series A Convertible Preferred Stock						Common Stock				Additional					Total
	Shares			Amount			Shares		Par Value		Paid-in Capital		Accumulated Deficit			Stockholders’ Equity

Three months ended June 30, 2025:
Balance, March 31, 2025		350,000		$	3,500,000			2,684,074	$	268	$	50,436,110	$	(52,777,248	)	$	1,159,130
Conversion of Series A convertible preferred stock		(350,000	)		(3,500,000	)		72,917		8		3,499,992		—			—
Stock-based compensation expense		—			—			—		—		267,999		—			267,999
Net loss		—			—			—		—		—		(775,673	)		(775,673	)
Balance, June 30, 2025		—		$	—			2,756,991	$	276	$	54,204,101	$	(53,552,921	)	$	651,456

Six months ended June 30, 2025:
Balance, December 31, 2024		350,000		$	3,500,000			2,249,290	$	225	$	49,394,687	$	(52,067,693	)	$	827,219
Proceeds from sale of securities in registered direct offering, net of offering costs		—			—			434,784		43		914,185		—			914,228
Stock options issued to settle accrued payable		—			—			—		—		27,500		—			27,500
Conversion of Series A convertible preferred stock		(350,000	)		(3,500,000	)		72,917		8		3,499,992		—			—
Stock-based compensation expense		—			—			—		—		367,737		—			367,737
Net loss		—			—			—		—		—		(1,485,228	)		(1,485,228	)
Balance, June 30, 2025		—		$	—			2,756,991	$	276	$	54,204,101	$	(53,552,921	)	$	651,456

(continued)

LIXTEBIOTECHNOLOGY HOLDINGS, INC.

ANDSUBSIDIARY

CONDENSEDCONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)

(Continued)

ThreeMonths and Six Months Ended June 30, 2025 and 2024

	Series A Convertible Preferred Stock				Common Stock				Additional					Total
	Shares		Amount		Shares		Par Value		Paid-in Capital		Accumulated Deficit			Stockholders’ Equity

Three months ended June 30, 2024:
Balance, March 31, 2024		350,000	$	3,500,000		2,249,290	$	225	$	49,079,192	$	(49,453,050	)	$	3,126,367
Stock-based compensation expense		—		—		—		—		130,691		—			130,691
Net loss		—		—		—		—		—		(1,010,919	)		(1,010,919	)
Balance, June 30, 2024		350,000	$	3,500,000		2,249,290	$	225	$	49,209,883	$	(50,463,969	)	$	2,246,139

Six months ended June 30, 2024:
Balance, December 31, 2023		350,000	$	3,500,000		2,249,290	$	225	$	48,976,265	$	(48,481,728	)	$	3,994,762
Balance		350,000	$	3,500,000		2,249,290	$	225	$	48,976,265	$	(48,481,728	)	$	3,994,762
Stock-based compensation expense		—		—		—		—		233,618		—			233,618
Net loss		—		—		—		—		—		(1,982,241	)		(1,982,241	)
Balance, June 30, 2024		350,000	$	3,500,000		2,249,290	$	225	$	49,209,883	$	(50,463,969	)	$	2,246,139
Balance		350,000	$	3,500,000		2,249,290	$	225	$	49,209,883	$	(50,463,969	)	$	2,246,139

Seeaccompanying notes to condensed consolidated financial statements.

LIXTEBIOTECHNOLOGY HOLDINGS, INC.

ANDSUBSIDIARY

CONDENSEDCONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

	2025			2024
	Six Months Ended June 30,
	2025			2024

Cash flows from operating activities:
Net loss	$	(1,485,228	)	$	(1,982,241	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense included in -
Research and development costs		—			—
General and administrative costs		367,737			233,618
Changes in operating assets and liabilities:
(Increase) decrease in -
Advances on research and development contract services		—			78,016
Prepaid insurance		6,301			(5,442	)
Other prepaid expenses		(2,290	)		(39,824	)
Increase (decrease) in -
Accounts payable and accrued expenses		36,443			(25,354	)
Research and development contract liabilities		21,069			132,961
Net cash used in operating activities		(1,055,968	)		(1,608,266	)

Cash flows from financing activities:
Proceeds from sale of securities in registered direct offering, net of offering costs		914,228			—
Payment of deferred offering costs		(10,000	)		—
Net cash provided by financing activities		904,228			—

Cash:
Net decrease		(151,740	)		(1,608,266	)
Balance at beginning of period		1,038,952			4,203,488
Balance at end of period	$	887,212		$	2,595,222

Supplemental disclosures of cash flow information:
Cash paid for -
Interest	$	4,945		$	11,340
Income taxes	$	—		$	—

Non-cash investing and financing activities:
Settlement of accrued compensation to Board of Directors by issuance of stock options	$	27,500		$	—
Conversion of Series A Convertible Preferred Stock into common stock	$	3,500,000		$	—
Accrual of deferred offering costs	$	188,826		$	—

Seeaccompanying notes to condensed consolidated financial statements.

LIXTEBIOTECHNOLOGY HOLDINGS, INC.

ANDSUBSIDIARY

NOTESTO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

ThreeMonths and Six Months Ended June 30, 2025 and 2024

1.Organization and Basis of Presentation

Thecondensed consolidated financial statements of Lixte Biotechnology Holdings, Inc., a Delaware corporation), including its wholly-ownedDelaware subsidiary, Lixte Biotechnology, Inc. (collectively, the “Company”), at June 30, 2025, and for the three monthsand six months ended June 30, 2025 and 2024, are unaudited. In the opinion of management of the Company, all adjustments, including normalrecurring accruals, have been made that are necessary to present fairly the financial position of the Company as of June 30, 2025, andthe results of its operations for the three months and six months ended June 30, 2025 and 2024, and its cash flows for the six monthsended June 30, 2025 and 2024. Operating results for the interim periods presented are not necessarily indicative of the results to beexpected for a full fiscal year. The condensed consolidated balance sheet at December 31, 2024 has been derived from the Company’saudited consolidated financial statements at such date.

Thecondensed consolidated financial statements and related notes have been prepared pursuant to the rules and regulations of the Securitiesand Exchange Commission (“SEC”). Accordingly, certain information and footnote disclosures normally included in financialstatements prepared in accordance with generally accepted accounting principles have been omitted pursuant to such rules and regulations.These condensed consolidated financial statements should be read in conjunction with the financial statements and other information includedin the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as filed with the SEC.

Business

TheCompany’s product pipeline is primarily focused on inhibitors of Protein Phosphatase 2A, which is used to enhance cytotoxic agents,radiation, immune checkpoint blockers and other cancer therapies. The Company believes that inhibitors of protein phosphatases have significanttherapeutic potential for a broad range of cancers. The Company is focusing on the clinical development of a specific protein phosphataseinhibitor, referred to as LB-100.

TheCompany’s activities are subject to significant risks and uncertainties, including the need for additional capital. The Companyhas not yet commenced any revenue-generating operations, does not have positive cash flows from operations, relies on stock-based compensationfor a substantial portion of employee and consultant compensation, and is dependent on periodic infusions of equity capital to fund itsoperating requirements.

NasdaqCompliance

TheCompany’s common stock and public warrants are traded on the Nasdaq Capital Market under the symbols “LIXT” and “LIXTW”,respectively.

OnJune 2, 2023, the Company effected a 1-for-10 reverse split of its outstanding shares of common stock in order to remain in compliancewith the $1.00 minimum closing bid price requirement of the Nasdaq Stock Market LLC (“Nasdaq”).

OnAugust 19, 2024, the Company received a letter from the Listing Qualifications Department (the “Staff”) of Nasdaq indicatingthat the Company was not in compliance with the minimum stockholders’ equity requirement of $2,500,000 for continued listing onthe Nasdaq Capital Market under Listing Rule 5550(b)(1) (the “Stockholders’ Equity Requirement”).

OnOctober 3, 2024, the Company submitted a plan to the Staff to regain compliance with the Stockholders’ Equity Requirement, whichoutlined the Company’s proposed initiatives to regain compliance by raising equity capital through various registered equity offerings.

OnOctober 21, 2024, the Staff provided notice (the “Notice”) to the Company that it had granted an extension through February18, 2025 to regain compliance with the Stockholders’ Equity Requirement, which required that the Company complete its capital raisinginitiatives and evidence compliance with the Stockholders’ Equity Requirement through filing a Current Report on Form 8-K withthe SEC providing certain required information.

Asof February 18, 2025, the Company had not regained compliance with the Stockholders’ Equity Requirement. On February 19, 2025,the Company received a Staff determination letter stating that the Company did not meet the terms of the extension because it did notcomplete its proposed financing initiatives to regain compliance. The Company timely requested a Hearing before a Nasdaq Hearings Panel(the “Panel”), which automatically stayed Nasdaq’s suspension or delisting of the Company’s common stock andpublic warrants pending the Panel’s decision.

OnApril 17, 2025, the Company received notice that the Panel had granted the Company an extension in which to regain compliance with allcontinued listing rules of the Nasdaq Capital Market. The Panel’s determination followed a hearing on April 3, 2025, at which thePanel considered the Company’s plan to regain compliance with the Stockholders’ Equity Requirement. As a result of the extension,the Panel granted the Company’s request for continued listing on the Nasdaq Capital Market, provided that the Company demonstratescompliance with the Stockholders’ Equity Requirement and all other continued listing requirements for the Nasdaq Capital Marketby July 3, 2025.

OnJuly 2, 2025, the Company closed a private placement for gross proceeds of $5,050,000, consisting of shares of common stock, pre-fundedwarrants to purchase shares of common stock, warrants to purchase shares of common stock, and shares of Series B Convertible PreferredStock, and on July 8, 2025, the Company closed a registered direct offering for gross proceeds of $1,500,000, consisting of shares ofcommon stock and pre-funded warrants to purchase shares of common stock.

OnJuly 15, 2025, the Company received notice from Nasdaq that the Panel found that the Company was in compliance with the Stockholders’Equity Requirement. The Company was also notified that it will remain subject to a “Panel Monitor”, as that term is definedin Nasdaq Listing Rule 5815(d)(4)(B), for a period of one year from the date of the Nasdaq notice, through July 15, 2026. If, duringthe term of the Panel Monitor, the Company does not continue to remain in compliance with the Stockholders’ Equity Requirement,the Company will not be provided with the opportunity to submit a compliance plan for review by the Listing Qualifications Staff andmust instead request a hearing before the Panel to address the deficiency, with such request staying any further action with respectto the Company’s listing on Nasdaq pending completion of the hearing process.

TheCompany is undertaking measures to maintain compliance under Nasdaq’s continued listing requirements and to remain listed on theNasdaq Capital Market. However, there can be no assurances that the Company will ultimately be able to maintain compliance with the Stockholders’Equity Requirement, or be able to maintain compliance with all other applicable requirements for continued listing on the Nasdaq CapitalMarket. The Company’s failure to meet these requirements would result in the Company’s securities being delisted from theNasdaq Capital Market.

GoingConcern

Forthe six months ended June 30, 2025, the Company recorded a net loss of $1,485,228 and used cash in operations of $1,055,968. At June30, 2025, the Company had cash of $887,212 available to fund its operations.

Becausethe Company is currently engaged in various early-stage clinical trials, it is expected that it will take a significant amount of timeand resources to develop any product or intellectual property capable of generating sustainable revenues. Accordingly, the Company’sbusiness is unlikely to generate any sustainable operating revenues in the next several years and may never do so. Even if the Companyis able to generate revenues through licensing its technology, product sales or other commercial activities, there can be no assurancethat the Company will be able to achieve and maintain positive earnings and operating cash flows. At June 30, 2025, the Company’sremaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurredaggregated approximately $524,000, which are currently scheduled to be incurred through approximately December 31, 2027.

TheCompany’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplatesthe realization of assets and satisfaction of liabilities in the normal course of business. The Company has no recurring source of revenuesand has experienced negative operating cash flows since inception. The Company has financed its working capital requirements throughthe recurring sale of its equity securities. These factors raise substantial doubt about the Company’s ability to continue as agoing concern within one year after the date the consolidated financial statements are issued. The consolidated financial statementsalso do not reflect any adjustments relating to the recoverability of assets and liabilities that might be necessary if the Company isunable to continue as a going concern.

TheCompany’s ability to continue as a going concern is dependent upon its ability to raise additional equity capital to fund its researchand development activities, including its ongoing clinical trials. The amount and timing of future cash requirements depends in substantialpart on the pace, design and results of the Company’s clinical trial program, which, in turn, depends on the availability of operatingcapital to fund such activities.

Basedon current operating plans, the Company estimates that its existing cash resources at June 30, 2025, together with the net proceeds fromthe July 2, 2025 private placement, and the July 8, 2025 registered direct offering, will provide sufficient working capital to fundthe Company’s operations as currently configured, including its ongoing clinical trial program with respect to the developmentof the Company’s lead anti-cancer clinical compound LB-100, for at least the next 12 months. However, existing cash resources willnot be sufficient to complete the development of and to obtain regulatory approval for the Company’s product candidate, which wouldrequire significant additional operating capital.

Inaddition, as a result of the appointment of a new Chairman and Chief Executive Officer in June 2025, the completion of the July 2025equity financings, and other changes in senior management and the Board of Directors in July 2025, the Company’s operating strategiesand business plans may change, including the incurrence of additional personnel and operating costs, which may require that the Companyraise additional capital to fund operations. However, as market conditions present uncertainty as to the Company’s ability to secureadditional funds, there can be no assurances that the Company will be able to secure additional financing on acceptable terms, as andwhen necessary, to continue to fund its operations.

TheCompany’s independent registered public accounting firm included an explanatory paragraph in their report with respect to thisuncertainty that accompanied the Company’s audited consolidated financial statements as of and for the year ended December 31,2024, in which they expressed substantial doubt about the Company’s ability to continue as a going concern. The Company’sconsolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Ifcash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale backor discontinue its clinical trial program, as well as its licensing and patent prosecution efforts and its technology and product developmentefforts, or obtain funds, if available, through strategic alliances, joint ventures or other transaction structures that could requirethe Company to relinquish rights to and/or control of LB-100, or to curtail or discontinue operations entirely.

2.Summary of Significant Accounting Policies

Principlesof Consolidation

Theaccompanying consolidated financial statements of the Company have been prepared in accordance with United States generally acceptedaccounting principles (“GAAP”) and include the financial statements of Lixte Biotechnology Holdings, Inc. and its wholly-ownedsubsidiary, Lixte Biotechnology, Inc. Intercompany balances and transactions have been eliminated in consolidation.

SegmentInformation

TheCompany’s Chief Executive Officer is the Company’s Chief Operating Decision Maker (“CODM”) and evaluates performanceand makes operating decisions about allocating resources based on internal financial data presented on a consolidated basis. Becausethe CODM evaluates financial performance on a consolidated basis, the Company has determined that it currently operates in a single reportablesegment, which consists of the development of a drug class called Protein Phosphatase 2A inhibitors, and is comprised of the consolidatedfinancial results of the Company. The CODM uses consolidated net income (loss) as the sole measure of segment profit or loss. The requiredsegment information, including significant segment expenses, is presented at Note 3.

Useof Estimates

Thepreparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reportedamounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period.Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates underdifferent assumptions or conditions. Management bases its estimates on historical experience and on various assumptions that are believedto be reasonable in relation to the financial statements taken, as a whole, under the circumstances, the results of which form the basisfor making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Managementregularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changesin facts and circumstances, historical experience, and reasonable assumptions. After such evaluations, if deemed appropriate, those estimatesare adjusted accordingly. Actual results could differ from those estimates. Significant estimates include those related to assumptionsused in the calculation of accruals for clinical trial costs and other potential liabilities, and valuing equity instruments issued forservices.

Cash

Cashis held in a cash bank deposit program maintained by Morgan Stanley Wealth Management, a division of Morgan Stanley Smith Barney LLC(“Morgan Stanley”). Morgan Stanley is a FINRA-regulated broker-dealer. The Company’s policy is to maintain its cashbalances with financial institutions in the United States with high credit ratings and in accounts insured by the Federal Deposit InsuranceCorporation (the “FDIC”) and/or by the Securities Investor Protection Corporation (the “SIPC”). The Company periodicallyhas cash balances in financial institutions in excess of the FDIC and SIPC insurance limits of $250,000 and $500,000, respectively. MorganStanley Wealth Management also maintains supplemental insurance coverage for the cash balances of its customers. The Company has notexperienced any losses to date resulting from this policy.

Researchand Development

Researchand development costs consist primarily of fees paid to consultants and contractors, and other expenses relating to the negotiation,design, development, conduct and management of clinical trials with respect to the Company’s clinical compound and product candidate.Research and development costs also include the costs to manufacture compounds used in research and clinical trials, which are chargedto operations as incurred. The Company’s inventory of LB-100 for clinical use has been manufactured separately in the United Statesand in the European Union in accordance with the laws and regulations of such jurisdictions.

Researchand development costs are generally charged to operations ratably over the life of the underlying contracts, unless the achievement ofmilestones, the completion of contracted work, the termination of an agreement, or other information indicates that a different expensingschedule is more appropriate. However, payments for research and development costs that are contractually defined as non-refundable arecharged to operations as incurred.

Obligationsincurred with respect to mandatory scheduled payments under agreements with milestone provisions are recognized as charges to researchand development costs in the Company’s consolidated statement of operations based on the achievement of such milestones, as specifiedin the respective agreement. Obligations incurred with respect to mandatory scheduled payments under agreements without milestone provisionsare accounted for when due, are recognized ratably over the appropriate period, as specified in the respective agreement, and are recordedas liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costs in theCompany’s consolidated statement of operations.

Paymentsmade pursuant to contracts are initially recorded as advances on research and development contract services in the Company’s consolidatedbalance sheet and are then charged to research and development costs in the Company’s consolidated statement of operations as thosecontract services are performed. Expenses incurred under contracts in excess of amounts advanced are recorded as research and developmentcontract liabilities in the Company’s consolidated balance sheet, with a corresponding charge to research and development costsin the Company’s consolidated statement of operations. The Company reviews the status of its various clinical trial and researchand development contracts on a quarterly basis.

PrepaidInsurance

Prepaidinsurance represents the premiums paid for directors and officers insurance coverage and for general liability insurance coverage inexcess of the amortization of the total policy premium charged to operations at each balance sheet date. Such amount is determined byamortizing the total policy premium charged on a straight-line basis over the respective policy period. As the policy premiums incurredare generally amortizable over the ensuing twelve-month period, they are recorded as a current asset in the Company’s consolidatedbalance sheet at each reporting date and appropriately amortized to the Company’s consolidated statement of operations for eachreporting period.

OfferingCosts

Offeringcosts consist of costs incurred with respect to equity financing transactions, including legal fees. Such costs are deferred and chargedto additional paid-in capital upon the successful completion of such financings, or are charged to operations if and when such financingsare abandoned or terminated.

Patentand Licensing Legal and Filing Fees and Costs

Dueto the significant uncertainty associated with the successful development of commercially viable products based on the Company’sresearch efforts and related patent applications, all patent and licensing legal and filing fees and costs related to the developmentand protection of the Company’s intellectual property are charged to operations as incurred. Patent and licensing legal and filingfees and costs were $17,303 and $63,612 for the three months ended June 30, 2025 and 2024, respectively, and $73,386 and $146,823 forthe six months ended June 30, 2025 and 2024, respectively. Patent and licensing legal and filing fees and costs are included in generaland administrative costs in the Company’s consolidated statement of operations.

Concentrationof Risk

TheCompany periodically contracts with vendors and consultants to provide services related to the Company’s operations. Charges incurredfor these services can be for a specific period (typically one year) or for a specific project or task. Costs and expenses incurred thatrepresented 10% or more of general and administrative costs or research and development costs for the three months ended June 30, 2025and 2024 are described below.

Researchand development costs for the three months ended June 30, 2025 include charges from five vendors and consultants representing 20.7%,19.5%, 17.9%, 17.8% and 11.2%, respectively, of total research and development costs. Research and development costs for the three monthsended June 30, 2024 include charges from three vendors and consultants representing 37.0%, 31.9% and 10.4%. respectively, of total researchand development costs.

Generaland administrative costs for the three months ended June 30, 2025 and 2024 include charges from legal firms and other vendors for generallicensing and patent prosecution costs relating to the Company’s intellectual properties representing 3.3% and 8.0%, respectivelyof total general and administrative costs. General and administrative costs for the three months ended June 30, 2025 also includes acharge from a vendor representing 11.9% of total general and administrative costs. General and administrative costs for the three monthsended June 30, 2024 include charges from two vendors and consultants representing 16.5% and 15.6%, respectively, of total general andadministrative costs. General and administrative costs for the three months ended June 30, 2025 and 2024 also included charges for thefair value of stock options granted to directors and corporate officers representing 33.7% and 12.9%, respectively, of total generaland administrative costs.

Researchand development costs for the six months ended June 30, 2025 include charges from five vendors and consultants representing 22.9%, 18.5%,16.3%, 16.2% and 12.7%, respectively, of total research and development costs. Research and development costs for the six months endedJune 30, 2024 include charges from three vendors and consultants representing 40.7%, 23.7% and 10.8%, respectively, of total researchand development costs.

Generaland administrative costs for the six months ended June 30, 2025 and 2024 include charges from legal firms and other vendors for generallicensing and patent prosecution costs relating to the Company’s intellectual properties representing 5.5% and 8.9%. respectively,of total general and administrative costs. General and administrative costs for the six months ended June 30, 2025 also include chargesfrom a vendor/consultant representing 12.5% of total general and administrative costs. General and administrative costs for the six monthsended June 30, 2024 also include charges from two vendors and consultants representing 15.1% and 12.2%, respectively, of total generaland administrative costs. General and administrative costs for the six months ended June 30, 2025 and 2024 also included charges forthe fair value of stock options granted to directors and corporate officers representing 23.5% and 12.5%, respectively, of total generaland administrative costs.

IncomeTaxes

TheCompany accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes. Accordingly,the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial statements andthe tax basis of assets and liabilities.

TheCompany records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized. Dueto the uncertainty of the Company’s ability to realize the benefit of the deferred tax assets, the net deferred tax assets arefully offset by a valuation allowance at June 30, 2025 and December 31, 2024. In the event the Company was to determine that it wouldbe able to realize its deferred tax assets in the future in excess of its recorded amount, an adjustment to the deferred tax assets wouldbe credited to operations in the period such determination was made. Should the Company determine that it would not be able to realizeall or part of its deferred tax assets in the future, an adjustment to the deferred tax assets would be charged to operations in theperiod such determination was made.

TheCompany is subject to U.S. federal income taxes and income taxes of various state tax jurisdictions. As the Company’s net operatinglosses have yet to be utilized, all previous tax years remain open to examination by Federal authorities and other jurisdictions in whichthe Company currently operates or has operated in the past. The Company did not have any unrecognized tax benefits as of June 30, 2025or December 31, 2024, and does not anticipate any material amount of unrecognized tax benefits through December 31, 2025.

TheCompany accounts for uncertainties in income tax law under a comprehensive model for the financial statement recognition, measurement,presentation, and disclosure of uncertain tax positions taken or expected to be taken in income tax returns as prescribed by GAAP. Thetax effects of a position are recognized only if it is “more-likely-than-not” to be sustained by the taxing authority asof the reporting date. If the tax position is not considered “more-likely-than-not” to be sustained, then no benefits ofthe position are recognized. The Company had not recorded any liability for uncertain tax positions as of June 30, 2025 or December 31,2024. Subsequent to June 30, 2025, any interest and penalties related to uncertain tax positions will be recognized as a component ofincome tax expense.

Stock-BasedCompensation

TheCompany periodically issues common stock and stock options to officers, directors, employees, contractors and consultants for servicesrendered. Options vest and expire according to terms established at the issuance date of each grant. Stock grants, which are generallytime vested, are measured at the grant date fair value and charged to operations ratably over the vesting period.

TheCompany accounts for stock-based payments to officers, directors, employees, contractors, and consultants by measuring the cost of servicesreceived in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation expenseon the straight-line basis in the Company’s financial statements over the vesting period of the awards. Recognition of compensationexpense for non-employees is in the same period and manner as if the Company had paid cash for the services.

Thefair value of stock options granted as stock-based compensation is determined utilizing the Black-Scholes option-pricing model, and isaffected by several variables, the most significant of which are the expected life of the stock option, the exercise price of the stockoption as compared to the fair market value of the common stock on the grant date, and the estimated volatility of the common stock.Unless sufficient historical exercise data is available, the expected life of the stock option is calculated as the mid-point betweenthe vesting period and the contractual term (the “simplified method”). The estimated volatility is based on the historicalvolatility of the Company’s common stock, calculated utilizing a look-back period approximately equal to the contractual life ofthe stock option being granted. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant.The fair market value of the common stock is determined by reference to the quoted market price of the Company’s common stock onthe grant date. The expected dividend yield is based on the Company’s expectation of dividend payouts and is assumed to be zero.

TheCompany recognizes the fair value of stock-based compensation awards in general and administrative costs and in research and developmentcosts, as appropriate, in the Company’s consolidated statements of operations. The Company issues new shares of common stock tosatisfy stock option exercises.

Warrants

TheCompany accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’sspecific terms and applicable authoritative guidance in Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilitiesfrom Equity (“ASC 480”), and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether thewarrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whetherthe warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to theCompany’s own common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstanceoutside of the Company’s control, among other conditions for equity classification. The Company has determined that the warrantsissued in the July 2023 equity financing, the February 2025 equity financing, and the July 2025 equity financings (see Note 4) meet therequirements for equity classification. This assessment, which requires the use of professional judgment, is conducted when the warrantsare issued and at the end each subsequent quarterly period while the warrants are outstanding. For issued or modified warrants that meetall of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capitalat the time of issuance. For issued or modified warrants that do not meet all of the criteria for equity classification, the warrantsare required to be liability-classified and recorded at their initial fair value on the date of issuance and remeasured at fair valueat each balance sheet date thereafter. Changes in the estimated fair value of the warrants that are liability-classified are recognizedas a non-cash gain or loss in the statement of operations at each balance sheet date. At June 30, 2025 and December 31, 2024, the Companydid not have any liability-classified warrants.

Earnings(Loss) Per Share

TheCompany’s computation of earnings (loss) per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured asthe income (loss) attributable to common stockholders divided by the weighted average common shares outstanding for the period. DilutedEPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares (e.g., preferred shares,warrants and stock options) as if they had been converted at the beginning of the respective periods presented, or issuance date, iflater. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share)are excluded from the calculation of diluted EPS.

Lossper common share is computed by dividing net loss by the weighted average number of common shares outstanding during the respective periods.Basic and diluted loss per common share was the same for all periods presented because all preferred shares, warrants and stock optionsoutstanding were anti-dilutive.

AtJune 30, 2025 and 2024, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquireshares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive.

	2025		2024
	June 30,
	2025		2024

Series A Convertible Preferred Stock		—		72,917
Common stock warrants		1,275,758		808,365
Common stock options		744,726		605,348
Total		2,020,484		1,486,630

ForeignCurrency Translation

Theconsolidated financial statements are presented in the United States dollar, which is the functional and reporting currency of the Company.

TheCompany periodically incurs a cost or expense in a foreign jurisdiction denominated in a local currency. The Company purchases the requiredforeign currency to pay such cost or expense on an as-needed basis. Such cost or expense is converted into United States dollars forfinancial statement purposes based on the foreign currency conversion rate in effect on the transaction date. The Company purchases therequisite foreign currency to pay such cost or expense on an as-needed basis. Any gain or loss resulting from the purchase of the foreigncurrency is included as foreign currency gain (loss) in the consolidated statement of operations.

Duringthe three months ended June 30, 2025 and 2024, the Company incurred various costs and expenses denominated in Euros, which were convertedinto United States dollars at the average rate of 1.1338 and 1.0766 Euros per United States dollar, respectively. During the six monthsended June 30, 2025 and 2024, the Company incurred various costs and expenses denominated in Euros, which were converted into UnitedStates dollars at the average rate of 1.0927 and 1.0813 Euros per United States dollar, respectively. As of June 30, 2025 and December31, 2024, the Company did not hold any currencies other than the United States dollar in its bank accounts, and was not a party to anyforeign currency forward or exchange contracts.

FairValue of Financial Instruments

Theauthoritative guidance with respect to fair value established a fair value hierarchy that prioritizes the inputs to valuation techniquesused to measure fair value into three levels and requires that assets and liabilities carried at fair value be classified and disclosedin one of three categories, as presented below. Disclosure as to transfers in and out of Levels 1 and 2, and activity in Level 3 fairvalue measurements, is also required.

Level1. Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability toaccess as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded securitiesand exchange-based derivatives.

Level2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observablethrough corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities,non-exchange-based derivatives, mutual funds, and fair-value hedges.

Level3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to developits own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently traded non-exchange-based derivativesand commingled investment funds and are measured using present value pricing models.

TheCompany determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based on thelowest level input that is significant to the fair value measurement in its entirety. In determining the appropriate levels, the Companyperforms an analysis of the assets and liabilities at each reporting period end.

Thecarrying value of financial instruments, which consists of accounts payable and accrued expenses is considered to be representative oftheir respective fair values due to the short-term nature of those instruments.

RecentAccounting Pronouncements

InNovember 2024, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2024-03,Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40). ASU 2024-03 amendsthe FASB Accounting Standards Codification to require specified information about certain costs and expenses in the notes to the financialstatements at each interim and annual reporting period, including disclosure of the amounts of purchases of inventory; employee compensation;depreciation; intangible asset amortization; and depreciation, depletion, and amortization included in each relevant expense captionon the face of the income statement within continuing operations that contains any of the expense categories previously listed. Disclosurewill also be required of the total amount of selling expenses and an entity’s definition of selling expenses in annual reportingperiods. ASU 2024-03 does not change or remove current expense disclosure requirements, but does affect where and how this informationis presented in the notes to the financial statements. ASU 2024-03 is effective for the Company for annual reporting periods beginningJanuary 1, 2027, and interim periods within annual reporting periods beginning January 1, 2028. Early adoption is permitted. The Companyis in the process of evaluating ASU 2024-03 to determine its impact on the Company’s consolidated financial statement presentationand related disclosures.

InJanuary 2025, the FASB issued ASU 2025-01, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures(Subtopic 220-40), Clarifying the Effective Date. ASU 2025-01 clarifies the effective date of ASU 2024-03 for all public business entitiesthat do not have an annual reporting period that ends on December 31 (referred to as non-calendar year-end entities). All public businessentities are required to adopt the disclosure requirements in the first annual reporting period beginning after December 15, 2026, andinterim reporting periods within annual reporting periods beginning after December 15, 2027. As the Company’s annual reportingperiod ends on December 31, ASU-2025-01 did not have any impact on the Company’s process of evaluating ASU-2024-03 to determineits impact on the Company’s consolidated financial statement presentation and related disclosures.

Managementdoes not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a materialimpact on the Company’s financial statements, including their presentation and related disclosures.

Reclassifications

Asa result of the adoption of ASU 2023-07 effective January 1, 2024, certain reclassifications have been made to the prior year statementof operations to conform it to the current year presentation. In presenting general and administrative costs on the Company’s consolidatedstatement of operations for the three months ended June 30, 2024, $306,354 of compensation to related parties, $63,612 of patent andlicensing legal and filing fees and costs, and $428,482 of other costs and expenses were shown separately. In presenting the Company’sconsolidated statement of operations for the three months ended June 30, 2024, the Company has combined these categories into generaland administrative costs in the accompanying consolidated statement of operations for the three months ended June 30, 2024. In presentinggeneral and administrative costs on the Company’s consolidated statement of operations for the six months ended June 30, 2024,$624,016 of compensation to related parties, $146,823 of patent and licensing legal and filing fees and costs, and $875,424 of othercosts and expenses were shown separately. In presenting the Company’s consolidated statement of operations for the six months endedJune 30, 2024, the Company has combined these categories into general and administrative costs in the accompanying consolidated statementof operations for the six months ended June 30, 2024. These reclassifications had no effect on the reported results of operations, includingloss from operations and net loss.

3.Segment Information

TheCompany’s chief operating decision maker (“CODM”) has been identified as the Company’s Chief Executive Officer(“CEO”). The Company’s CODM evaluates performance and makes operating decisions about allocating resources based onfinancial data presented on a consolidated basis. Because the CODM evaluates financial performance on a consolidated basis, the Companyhas determined that it currently has a single operating segment which is comprised of the consolidated financial results of the Company.

Thefollowing table presents the significant segment expenses (10% or greater) and other segment items regularly reviewed by the Company’sCODM and included in research and development costs for the three months and six months ended June 30, 2025 and 2024.

Schedule of Information by Segment

	2025		2024		2025		2024
	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2025		2024		2025		2024

Clinical and related oversight costs	$	11,601	$	97,947	$	27,470	$	107,977
Preclinical research focused on development of additional novel anti-cancer compounds		27,592		104,829		70,362		209,309
Compound maintenance		20,265		5,976		53,083		9,870
Regulatory service costs		1,190		1,956		1,190		2,616
Total research and development costs	$	60,648	$	210,708	$	152,105	$	329,772

Thefollowing table presents a summary of research and development costs for the three months and six months ended June 30, 2025 and 2024based on the respective geographical regions where such costs were incurred.

	2025		2024		2025		2024
	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2025		2024		2025		2024

United States	$	41,928	$	114,345	$	100,499	$	148,928
Spain		18,720		29,244		51,606		44,478
China		—		—		—		2,282
Netherlands		—		67,119		—		134,084
Total research and development costs	$	60,648	$	210,708	$	152,105	$	329,772

Thefollowing table presents the significant segment expenses (10% or greater) and other segment items regularly reviewed by the Company’sCODM and included in general and administrative costs for the three months and six months ended June 30, 2025 and 2024.

	2025		2024		2025		2024
	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2025		2024		2025		2024

Compensation to related parties:
Cash-based	$	123,285	$	175,663	$	232,016	$	390,398
Stock-based		267,999		130,691		367,737		233,618
Patent and licensing legal and filing fees and costs		17,303		63,612		73,386		146,823
Other consulting and professional fees		176,551		191,529		381,867		363,972
Insurance expense		64,277		126,873		128,553		253,727
Other costs and expenses, net		64,746		110,080		146,085		257,725
Total general and administrative costs	$	714,161	$	798,448	$	1,329,644	$	1,646,263

Thefollowing table presents the Company’s total assets by segment at June 30, 2025 and December 31, 2024.

	June 30, 2025		December 31, 2024

Research and development assets	$	20,041	$	39,298
Corporate assets (primarily cash)		1,168,537		1,106,205
Total assets	$	1,188,578	$	1,145,503

4.Stockholders’ Equity

PreferredStock

TheCompany is authorized to issue a total of 10,000,000 shares of preferred stock, par value $0.0001 per share.

OnMarch 17, 2015, the Company filed a Certificate of Designations, Preferences, Rights and Limitations of its Series A Convertible PreferredStock with the Delaware Secretary of State to amend the Company’s certificate of incorporation. The Company has designated a totalof 350,000 shares as Series A Convertible Preferred Stock, which are non-voting and are not subject to increase without the written consentof a majority of the holders of the Series A Convertible Preferred Stock or as otherwise set forth in the Preferences, Rights and Limitations.The holders of each tranche of 175,000 shares of the Series A Convertible Preferred Stock are entitled to receive a per share dividendequal to 1% of the annual net revenue of the Company divided by 175,000, until converted or redeemed. Each share of Series A ConvertiblePreferred Stock was convertible, at the option of the holder, into 0.20833 shares of common stock (subject to customary anti-dilutionprovisions) and the Series A Convertible Preferred Stock is subject to mandatory conversion at the conversion rate in the event of amerger or sale transaction resulting in gross proceeds to the Company of at least $21,875,000. The Series A Convertible Preferred Stockhad a liquidation preference based on its assumed conversion into shares of common stock. The Series A Convertible Preferred Stock didnot have any cash liquidation preference rights or any registration rights. Based on the attributes of the Series A Convertible PreferredStock as previously described, the Company accounted for the Series A Convertible Preferred Stock as a permanent component of stockholders’equity. The 350,000 outstanding shares of Series A Convertible Preferred Stock were converted into a total of 72,917 shares of commonstock pursuant to a notice of conversion dated May 16, 2025.

Asof June 30, 2025 and December 31, 2024, the Company had 9,650,000 shares of undesignated preferred stock, which may be issued with suchrights and powers as the Board of Directors may designate. The Company expects to amend its certificate of incorporation to eliminatethe Series A Convertible Preferred Stock classification.

OnJuly 2, 2025, the Company closed a private placement for gross proceeds of $5,050,000, consisting, in part, of shares of Series B ConvertiblePreferred Stock (see Note 9).

CommonStock

TheCompany is authorized to issue a total of 100,000,000 shares of common stock, par value $0.0001 per share. As of June 30, 2025 and December31, 2024, the Company had 2,756,991 shares and 2,249,290 shares, respectively, of common stock issued and outstanding.

July20, 2023 equity offering

EffectiveJuly 20, 2023, the Company sold 180,000 shares of common stock at a price of $6.00 per share and pre-funded warrants to purchase 403,334shares of common stock at a price of $5.9999 per pre-funded warrant to an institutional investor in a registered direct offering. Thepre-funded warrants had an exercise price of $0.0001 per share, were immediately exercisable upon issuance, and were valid and exercisableuntil all pre-funded warrants were exercised in full. During the period from July 24, 2023 through August 7, 2023, the 403,334 pre-fundedwarrants, exercisable at $0.0001 per common share, were exercised for total cash proceeds of $41, resulting in the issuance of 403,334shares of common stock. The pre-funded warrants were determined to be common stock equivalents.

Ina concurrent private placement to the institutional investor, the Company also sold warrants to purchase 583,334 shares of common stock.Each common warrant had an initial exercise price of $6.00 per share, was immediately exercisable upon issuance, and expires five yearsthereafter on July 20, 2028. The common warrants and the shares of common stock issuable upon exercise of the common warrants were notregistered under the Securities Act of 1933, as amended (the “Securities Act”) and were offered pursuant to the exemptionprovided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder. The shares of common stock issuable uponexercise of the warrants were registered for resale in a registration statement on Form S-3 declared effective by the SEC on May 2, 2024.

Theregistered direct offering and the concurrent private placement generated gross proceeds of $3,499,964. The total cash costs of the registereddirect offering and the private placement were $362,925, resulting in net proceeds of $3,137,039. Pursuant to the placement agent agreement,the Company granted the placement agent warrants to purchase 35,000 shares of common stock at an exercise price of $6.60 per share andexpiring on July 20, 2028. The net proceeds from the registered direct offering and the concurrent private placement were used for generalworking capital purposes.

Theexercise prices of the warrants issued to the institutional investor (exercisable at $6.00 per share) and to the placement agent (exercisableat $6.60 per share) are subject to customary adjustments for stock splits, stock dividends, stock combinations, reclassifications, reorganizations,or similar events affecting the Company’s common stock. In addition, the warrants issued to the institutional investor containa “fundamental transaction” provision which provides that if any defined fundamental transactions are within the Company’scontrol and are consummated, the holder of the unexercised common stock warrants would be entitled to receive, at its option, in exchangefor extinguishment of such warrants, cash consideration equal to a Black-Scholes valuation amount, as defined in the warrant agreement.

Thefundamental transaction provision includes (i) a sale, lease, assignment, transfer, conveyance or other disposition of all or substantiallyall of the assets of the Company in one or a series of related transactions, or (ii) a change in control of the Company by which it,directly or indirectly, in one or more related transactions, consummates a stock or share purchase agreement or other business combinationwith another person or group, whereby such other person or group acquires more than 50% of the voting power of the common equity of theCompany.

Ifsuch fundamental transaction is not within the Company’s control, including not being approved by the Company’s Board ofDirectors, the warrant holder would only be entitled to receive the same type or form of consideration (and in the same proportion) equalto the Black-Scholes valuation amount of the remaining unexercised portion of the warrant on the date of consummation of such fundamentaltransaction as the holders of the Company’s common stock receive. Accordingly, these warrants are classified as a component ofpermanent stockholders’ equity. The Company will account for any cash payment for a warrant redemption as a distribution from stockholders’equity, as and when a fundamental transaction is consummated and such cash payment is required to be made.

February13, 2025 equity offering

EffectiveFebruary 13, 2025, the Company sold, in a registered direct offering, an aggregate of 434,784 shares of the Company’s common stockat an offering price of $2.415 per share, and in a concurrent private placement, warrants to purchase an aggregate of 434,784 sharesof common stock. The common stock warrants were immediately exercisable for a term of five years from issuance at an exercise price of$2.29 per share.

Thecommon stock warrants and the shares of common stock underlying the common stock warrants were not registered under the Securities Act,and were issued in reliance on an exemption from the registration requirements of the Securities Act afforded by Section 4(a)(2) thereof.The shares of common stock issuable upon exercise of the common stock warrants were registered for resale in a registration statementon Form S-1 declared effective by the SEC on April 10, 2025.

Theregistered direct offering and the concurrent private placement generated gross proceeds of $1,050,003 before deducing the placementagent’s fee and related offering costs of $135,775, resulting in net proceeds of $914,228. Pursuant to the placement agent agreement,the Company granted the placement agent warrants to purchase 32,609 shares of common stock at an exercise price of $3.0188 per shareand expiring on February 11, 2030. The net proceeds from the registered direct offering and the concurrent private placement will beused for general working capital purposes.

Theexercise prices of the warrants issued to the institutional investors (exercisable at $2.29 per share) and to the placement agent (exercisableat $3.0188 per share) are subject to customary adjustments for stock splits, stock dividends, stock combinations, reclassifications,reorganizations, or similar events affecting the Company’s common stock. In addition, the warrants issued to the institutionalinvestor and to the placement agent contain a “fundamental transaction” provision which provides that if any defined fundamentaltransactions are within the Company’s control and are consummated, the holder of the unexercised common stock warrants would beentitled to receive, at its option, in exchange for extinguishment of such warrants, cash consideration equal to a Black-Scholes valuationamount, as defined in the warrant agreement.

July2, 2025 equity offering

OnJuly 2, 2025, the Company closed a private placement for gross proceeds of $5,050,000, consisting, in part, of shares of common stock,pre-funded warrants to purchase shares of common stock, and warrants to purchase shares of common stock (see Note 9). The pre-fundedwarrants were determined to be common stock equivalents.

Theexercise prices of the warrants issued to the purchasers and to the placement agent are subject to customary adjustments for stock splits,stock dividends, stock combinations, reclassifications, reorganizations, or similar events affecting the Company’s common stock.In addition, the warrants issued contain a “fundamental transaction” provision whereby in the event of a fundamental transaction(including a sale or transfer of assets or ownership of the Company as defined in the warrant agreement) within the Company’s control,the holders of the unexercised common stock warrants would be entitled to receive, in exchange for extinguishment of the warrants, cashconsideration equal to a Black-Scholes valuation, as defined in the warrant agreement. If such fundamental transaction is not withinthe Company’s control, the warrant holders would only be entitled to receive the same form of consideration (and in the same proportion)as the holders of the Company’s common stock.

Accordingly,in the event of a change in control of the Company or a sale or transfer of all or substantially all of the Company’s assets, asdefined in the July 2, 2025 warrants, to the extent that the warrants are outstanding at the effective date that such a transaction isclosed, this “fundamental transaction” provision would entitle the holders to substantial cash consideration, thus reducingthe amounts to be retained by the Company or potentially distributable to the Company’s stockholders.

July8, 2025 equity offering

OnJuly 8, 2025, the Company closed a registered direct offering for gross proceeds of $1,500,000, consisting of shares of common stockand pre-funded warrants to purchase shares of common stock (see Note 9). The pre-funded warrants were determined to be common stock equivalents.

CommonStock Warrants

Asummary of common stock warrant activity, including warrants to purchase common stock that were issued in conjunction with the Company’spublic offerings, is presented below.

Schedule of Warrants Outstanding

	Number of Shares		Weighted Average Exercise Price		Weighted Average Remaining Contractual Life (in Years)

Warrants outstanding at December 31, 2024		808,365	$	16.407
Issued		467,393		2,341
Exercised		—		—
Expired		—		—
Warrants outstanding at June 30, 2025		1,275,758	$	11.254		3.27

Warrants exercisable at December 31, 2024		808,365	$	16.407
Warrants exercisable at June 30, 2025		1,275,758	$	11.254		3.27

AtJune 30, 2025, the outstanding warrants are exercisable at the following prices per common share:

Exercise Prices		Warrants Outstanding (Shares)

$	2.2900		434,784
$	3.0188		32,609
$	6.0000		583,334
$	6.6000		35,000
$	20.0000		29,000
$	37.0000		11,331
$	57.0000		149,700
			1,275,758

Thewarrants exercisable at $57.00 per share at June 30, 2025 consist of 1,497,000 publicly-traded warrants, described herein on a pre-split1-for-10 basis, that were issued as part of the Company’s November 2020 public offering of units, and are exercisable for a periodof five years thereafter. As a result of the 1-for-10 reverse split of the Company’s common stock effective June 2, 2023, eachsuch publicly-traded warrant currently now represents the right to purchase 1/10th of a share of common stock at the original exerciseprice of $5.70 per share. Accordingly, the exercise of 10 warrants, each exercisable at $5.70, are required to acquire one share of post-splitcommon stock, which is equivalent to a purchase price of $57.00 per share.

Basedon the closing fair market value of $0.905 per common share on June 30, 2025, there was no intrinsic value attributed to exercisablebut unexercised common stock warrants at June 30, 2025.

Informationwith respect to the issuance of common stock in connection with various stock-based compensation arrangements is provided at Note 6.

5.Related Party Transactions

Relatedparty transactions include transactions with the Company’s officers, directors and affiliates.

EmploymentAgreements with Officers

DuringJuly and August 2020, the Company entered into one-year employment agreements with each of its executive officers at that time, consistingof Dr. John S. Kovach, Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten, payable monthly, as described below. These employmentagreements were automatically renewable for additional one-year periods unless terminated by either party upon 60 days written noticeprior to the end of the applicable one-year period, or by death, or by termination for cause. Except as noted below, these employmentagreements were automatically renewed for additional one-year periods in July and August 2021, 2022, 2023 and 2024.

TheCompany entered into an employment agreement with Dr. Kovach dated July 15, 2020, effective October 1, 2020, to provide for Dr. Kovachto continue to act as the Company’s President, Chief Executive Officer and Chief Scientific Officer, with an annual salary of $250,000.The employment agreement with Dr. Kovach terminated upon his death on October 5, 2023.

TheCompany entered into an employment agreement with Dr. James S. Miser, M.D., effective August 1, 2020, to act as the Company’s ChiefMedical Officer, with an annual salary of $150,000. Effective May 1, 2021, Dr. Miser’s annual salary was increased to $175,000.Dr. Miser was required to devote at least 50% of his business time to the Company’s activities. On May 29, 2024, the Company electednot to renew its employment agreement with Dr. Miser, as a result of which such employment agreement expired on July 31, 2024. Duringthe three months and six months ended June 30, 2024, the Company paid $43,750 and $87,500, respectively, to Dr. Miser under this employmentagreement, which costs are included in general and administrative costs in the Company’s consolidated statements of operationsfor such periods.

TheCompany entered into an employment agreement with Eric J. Forman effective July 15, 2020, as amended on August 12, 2020, to act as theCompany’s Chief Administrative Officer, with an annual salary of $120,000. Mr. Forman is the son-in-law of Gil Schwartzberg (deceased),a former member of the Company’s Board of Directors who died on October 30, 2022 and was a significant stockholder of and consultantto the Company, and is the son of Dr. Stephen Forman, a member of the Company’s Board of Directors. Julie Forman, the wife of Mr.Forman and the daughter of Gil Schwartzberg, is Vice President of Morgan Stanley Wealth Management, at which firm the Company’scash is on deposit and with which the Company maintains a continuing banking relationship. Effective May 1, 2021, Mr. Forman’sannual salary was increased to $175,000. Additionally, effective November 6, 2022, Mr. Forman was promoted to Vice President and ChiefOperating Officer with an annual salary of $200,000. The employment agreement with Mr. Forman terminated upon his resignation as an officerof the Company effective December 31, 2024. During the three months and six months ended June 30, 2024, the Company paid $50,000 and$100,000, respectively, to Mr. Forman under this employment agreement, which costs are included in general and administrative costs inthe Company’s consolidated statements of operations for such periods. Additionally, Mr. Forman was provided a monthly office rentallowance, pursuant to which the Company paid $3,780 and $9,098 during the three months and six months ended June 30, 2024.

TheCompany entered into an employment agreement with Robert N. Weingarten effective August 12, 2020 to act as the Company’s Vice Presidentand Chief Financial Officer, with an annual salary of $120,000. Effective May 1, 2021, Mr. Weingarten’s annual salary was increasedto $175,000. During the three months ended June 30, 2025 and 2024, the Company paid $43,750 and $43,750, respectively, to Mr. Weingartenunder this employment agreement, which costs are included in general and administrative costs in the Company’s consolidated statementsof operations for such periods. During the six months ended June 30, 2025 and 2024, the Company paid $87,500 and $87,500, respectively,to Mr. Weingarten under this employment agreement, which costs are included in general and administrative costs in the Company’sconsolidated statements of operations for such periods.

TheCompany entered into an employment agreement with Bastiaan van der Baan effective September 26, 2023 to act as the Company’s Presidentand Chief Executive Officer and as Vice Chairman of the Board of Directors, with an annual salary of $150,000. Effective October 6, 2023,Mr. van der Baan was appointed as Chairman of the Board of Directors upon the death of Dr. Kovach on October 5, 2023. Effective June16, 2025, the employment agreement was amended to provide that Mr. van der Baan will serve as President and Chief Scientific Officerof the Company. Mr. van der Baan’s annual salary may be increased from time to time at the sole discretion of the Board of Directors.In addition, Mr. van der Baan is eligible to receive an annual bonus as determined at the sole discretion of the Board of Directors.The term of the employment agreement is for three years and is automatically renewable for additional one-year periods unless terminatedby either party, subject to early termination provisions as described in the employment agreement. During the three months ended June30, 2025 and 2024, the Company paid $39,724 and $38,163, respectively, to Mr. van der Baan under this employment agreement, which costsare included in general and administrative costs in the Company’s consolidated statements of operations for such periods. Duringthe six months ended June 30, 2025 and 2024, the Company paid $77,201 and $76,579, respectively, to Mr. van der Baan under this employmentagreement, which costs are included in general and administrative costs in the Company’s consolidated statements of operationsfor such periods.

OnMay 31, 2024, the Company entered into a consulting agreement with Dr. Jan H.M. Schellens, M.D., Ph.D. Pursuant to the agreement, effectiveJuly 1, 2024, the Company engaged Dr. Schellens as a consultant, and, effective August 1, 2024, as the Company’s Chief MedicalOfficer. The term of the agreement is in effect from July 1, 2024 until the earliest of (i) termination by either party upon sixty days’notice, (ii) Dr. Schellens’ death or disability, or (iii) termination by the Company for breach as provided in the agreement. Underthe agreement, Dr. Schellens provides his services for two days per week with the specific days in each week based on arrangements agreedto from time to time between Dr. Schellens and the Company’s Chief Executive Officer. The Company pays Dr. Schellens an annualcompensation of 104,000 Euros (approximately $122,000 as of June 30, 2025), payable on a monthly basis. During the three months endedJune 30, 2025 and 2024, the Company paid $29,811 and $0, respectively, to Dr. Schellens under this consulting agreement, which costsare included in general and administrative costs in the Company’s consolidated statements of operations for such periods. Duringthe six months ended June 30, 2025 and 2024, the Company paid $57,315 and $0, respectively, to Dr. Schellens under this consulting agreement,which costs are included in general and administrative costs in the Company’s consolidated statements of operations for such periods.Effective as of July 31, 2025, the Company agreed to accept the resignation of Dr. Schellens andto terminate his consulting agreement, to allow Dr. Schellens to pursue other employment opportunities.

Effectiveas of June 15, 2022, Dr. René Bernards was appointed to the Company’s Board of Directors as an independent director. Dr.Bernards is a leader in the field of molecular carcinogenesis and is employed by the Netherlands Cancer Institute in Amsterdam. Uponhis appointment, it was agreed that Dr. Bernards would receive annual compensation for his services on the Board of Directors only inthe form of cash, in lieu of the annual June 30 grant of stock options as provided to the Company’s other non-officer directors.During the three months ended June 30, 2025 and 2024, the Company recorded charges to general and administrative costs in the consolidatedstatements of operations of $0 and $0, respectively, with respect to his annual cash board compensation. During the six months endedJune 30, 2025 and 2024, the Company recorded charges to general and administrative costs in the consolidated statements of operationsof $0 and $10,000, respectively, with respect to his annual cash board compensation.

Inconjunction with the Company’s efforts to preserve cash during 2024, effective with the quarter ended June 30, 2024, Dr. Bernardsagreed to receive equity-based compensation for his services on the Board of Directors, for the quarters ended June 30, 2024 throughDecember 31, 2024. In order to reconcile his Board of Directors compensation with that of the other non-officer directors, Dr. Bernardshas agreed to receive the same Board of Directors compensation, both in form and amount, as the other non-officer directors for the yearending December 31, 2025.

Previously,on October 8, 2021, the Company had entered into a Development Collaboration Agreement (subsequently amended and extended) with the NetherlandsCancer Institute, Amsterdam, one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independentcancer research center, to identify the most promising drugs to be combined with LB-100, and potentially LB-100 analogues, to be usedto treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations (see Note8).

EffectiveJune 16, 2025, the Company entered into an employment agreement with Geordan Pursglove pursuant to which Mr. Pursglove was appointedas the Company’s Chief Executive Officer and Chairman of the Board of Directors for a term of three years, subject to automatictermination if the Company did not complete a successful financing that would enable it to maintain its listing on the Nasdaq CapitalMarket by July 3, 2025, which was accomplished on July 2, 2025. Under the employment agreement, Mr. Pursglove will receive an annualsalary of $240,000, which may be increased from time to time in the sole discretion of the Board of Directors. At his election, Mr. Pursglove’scompensation will be payable in cash and/or restricted shares of common stock, or a combination thereof. He will also be eligible toreceive an annual bonus as determined in the sole discretion of the Board of Directors in the form of cash or equity, or a combinationthereof. Mr. Pursglove will not receive any additional compensation for serving as Chairman of the Board of Directors. During the threemonths and six months ended June 30, 2025, the Company paid $10,000 to Mr. Pursglove under this employment agreement, which cost is includedin general and administrative costs in the Company’s consolidated statements of operations for such periods.

Effectiveas of July 3, 2025, the end of the first trading day of the Company’s common stock immediately following the successful completionof the above referenced financing, as an inducement to Mr. Pursglove to join the Company, as a signing bonus, Mr. Pursglove was granteda stock option to purchase 350,000 shares of the Company’s common stock at an exercise price of $2.83 per share (the closing marketprice on the grant date), for a term of five years, exercisable on a cashless basis and vesting 50% on the grant date, 25% on September30, 2025, and 25% on December 31, 2025, subject to continued service. The stock option grant was not issued under the Company’s2020 Stock Incentive Plan. The stock option agreement provides for certain registration rights and for accelerated vesting upon the occurrenceof certain events, including early termination of the agreement that is not the result of his voluntary termination or termination forcause, a sale or change in control of the Company, or a sale, licensing or other disposition of all or substantially all of the assetsof the Company. The total fair value of the stock options to purchase 350,000 shares of common stock, as calculated pursuant to the Black-Scholesoption-pricing model, was determined to be $728,671 ($2.0819 per share), which will be charged to operations from July 3, 2025 throughDecember 31, 2025.

CompensatoryArrangements for Members of the Board of Directors

EffectiveApril 9, 2021, the Board of Directors approved a comprehensive cash and equity compensation program for the non-officer directors fortheir services on the Board of Directors, which was subsequently amended effective May 25, 2022, July 9, 2024, and March 21, 2025. Subsequentto June 30, 2025, the Board of Directors commenced a review of this compensation program and is considering further revisions.

Officerswho also serve on the Board of Directors are not compensated separately for their service on the Board of Directors.

Cashcompensation for directors, payable quarterly, is as follows:

Basedirector compensation - $20,000 per year (except for Dr. Bernards, who was paid an additional annual cash fee of $40,000, in lieu ofthe annual June 30 grant of stock option as described below, through March 31, 2024)

Chairmanof audit committee – additional $10,000 per year

Chairmanof any other committees – additional $5,000 per year

Memberof audit committee – additional $5,000 per year

Memberof any other committees – additional $2,500 per year

Inconjunction with the Company’s efforts to preserve cash, the Board of Directors approved amendments to this compensation program,such that for the quarters ended June 30, 2024 through December 31, 2025, the non-officer directors (including Dr. Bernards) have receivedor will receive, in lieu of cash compensation, stock options exercisable for a period of five years, vesting immediately, to purchasecommon stock at an exercise price based on the closing market price upon issuance, with the amount of such stock options equal to thecash payment such director would otherwise have been entitled to receive for such quarter, divided by their quarterly value as determinedpursuant to the Black-Scholes option-pricing model.

Equitycompensation for directors is as follows:

Appointmentof new directors – The Company grants options to purchase 25,000 shares of common stock, exercisable for a period of five years,at the closing market price on the date of grant, vesting 50% on the grant date and the remaining 50% vesting 12.5% on the last day ofeach calendar quarter beginning in the quarter immediately subsequent to the date of the grant until fully vested, subject to continuedservice. At the discretion of the Board of Directors, for a nominee to the Board of Directors who is restricted by their respective institutionor employer from receiving equity-based compensation, in lieu of the grant of such stock options, the Company may elect to pay a one-timecash fee of $100,000 to such director, payable upfront.

Annualgrant of options to directors – Effective on the last business day of the month of June, the Company grants options to purchase10,000 shares of common stock, exercisable for a period of five years, at the closing market price on the date of grant, vesting 12.5%on the last day of each calendar quarter beginning in the quarter immediately subsequent to the date of grant until fully vested, subjectto continued service. If any director has served for less than 12 full calendar months on the grant date, the amount of such stock optiongrant is prorated based on the length of service of such director. At the discretion of the Board of Directors, for a nominee to theBoard of Directors who is restricted by their respective institution or employer from receiving equity-based compensation, in lieu ofthe grant of such stock options, the Company may elect to pay an annual cash fee of $40,000 to such director, payable quarterly.

Totalcash compensation paid to non-officer directors was $0 and $0, respectively, for the three months ended June 30, 2025 and 2024. Totalcash compensation paid to non-officer directors was $0 and $38,819, respectively, for the six months ended June 30, 2025 and 2024.

Stock-basedcompensation granted to members of the Company’s Board of Directors, officers and affiliates is described at Note 6.

Asummary of related party costs, including compensation under employment and consulting agreements and fees paid to non-officer directorsfor their services on the Board of Directors, for the three months and six months ended June 30, 2025 and 2024, is presented below.

Summary of Related Party Costs

	2025		2024		2025		2024
	Three Months Ended June 30,				Six Months Ended June 30,
	2025		2024		2025		2024

Related party costs:
Cash-based	$	123,285	$	175,663	$	232,016	$	390,398
Stock-based		267,999		130,691		367,737		233,618
Total	$	391,284	$	306,354	$	599,753	$	624,016

6.Stock-Based Compensation

TheCompany periodically issues common stock and stock options as incentive compensation to directors and as compensation for the servicesof employees, contractors, and consultants of the Company.

OnJuly 14, 2020, the Board of Directors of the Company adopted the 2020 Stock Incentive Plan (the “2020 Plan”), which was subsequentlyapproved by the stockholders of the Company. The 2020 Plan provides for the granting of equity-based awards, consisting of stock options,restricted stock, restricted stock units, stock appreciation rights, and other stock-based awards to employees, officers, directors andconsultants of the Company and its affiliates, initially for a total of 233,333 shares of the Company’s common stock, under termsand conditions as determined by the Company’s Board of Directors. On October 7, 2022, the stockholders of the Company approvedan amendment to the 2020 Plan to increase the number of common shares issuable thereunder by 180,000 shares, to a total of 413,333 shares.On November 27, 2023, the stockholders of the Company approved an amendment to the 2020 Plan to increase the number of common sharesissuable thereunder by 336,667 shares, to a total of 750,000 shares.

Asof June 30, 2025, unexpired stock options for 699,309 shares were issued and outstanding under the 2020 Plan and 50,691 shares were availablefor issuance under the 2020 Plan.

Thefair value of a stock option award is calculated on the grant date using the Black-Scholes option-pricing model. The risk-free interestrate is based on the U.S. Treasury yield curve in effect as of the grant date. The expected dividend yield assumption is based on theCompany’s expectation of dividend payouts and is assumed to be zero. The estimated volatility is based on the historical volatilityof the Company’s common stock, calculated utilizing a look-back period approximately equal to the contractual life of the stockoption being granted. Unless sufficient historical exercise data is available, the expected life of the stock option is calculated asthe mid-point between the vesting period and the contractual term (the “simplified method”). The fair market value of thecommon stock is determined by reference to the quoted market price of the common stock on the grant date.

Forstock options requiring an assessment of value during the six months ended June 30, 2025, the fair value of each stock option award wasestimated using the Black-Scholes option-pricing model with the following assumptions:

Risk-free interest rate	3.80% to 3.950		%
Expected dividend yield		0	%
Expected volatility		128.78% to 130.70	%
Expected life		2.5 to 3.5 years

Forstock options requiring an assessment of value during the six months ended June 30, 2024, the fair value of each stock option award wasestimated using the Black-Scholes option-pricing model with the following assumptions:

Risk-free interest rate	4.290	%
Expected dividend yield	0	%
Expected volatility	126.45	%
Expected life	2.5 to 3.5 years

OnJune 17, 2022, the Board of Directors appointed Bas van der Baan to the Board of Directors. In connection with his appointment to theBoard of Directors, and in accordance with the Company’s cash and equity compensation package for members of the Board of Directors,Mr. van der Baan was granted stock options to purchase 25,000 shares of the Company’s common stock, exercisable for a period offive years at an exercise price of $7.40 per share (the closing market price on the grant date), vesting 50% on the grant date and theremainder vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested, subject to continued service. Thefair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $158,525 ($6.341per share), of which $79,263 was attributable to the portion of the stock options fully vested on June 17, 2022 and was therefore chargedto operations on that date. The remaining unvested portion of the fair value of the stock options was charged to operations ratably fromJune 17, 2022 through June 30, 2024. During the three months and six months ended June 30, 2024, the Company recorded charges to generaland administrative costs in the consolidated statement of operations of $9,695 and $19,390, respectively, with respect to these stockoptions.

OnJune 30, 2022, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of theBoard of Directors, granted to each of the five non-officer directors of the Company stock options to purchase 10,000 shares (a totalof 50,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $7.40 per share(the closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested,subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model,was determined to be $316,700 ($6.334 per share), which was charged to operations ratably from July 1, 2022 through June 30, 2024. Duringthe three months and six months ended June 30, 2024, the Company recorded a charge to general and administrative costs in the consolidatedstatement of operations of $23,655 and $47,310, respectively, with respect to these stock options.

OnNovember 6, 2022, the Board of Directors granted to each of the four officers of the Company stock options to purchase 20,000 shares(a total of 80,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $20.00per share, vesting 25% on issuance and 25% on each anniversary date thereafter until fully vested, subject to continued service. Thetotal fair value of the 80,000 stock options, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be$262,560 ($3.282 per share), which is being charged to operations ratably from November 6, 2022 through November 6, 2025. During thethree months ended June 30, 2025 and 2024, the Company recorded charges to general and administrative costs in the consolidated statementsof operations of $4,088 and $12,396, respectively, with respect to these stock options. During the six months ended June 30, 2025 and2024, the Company recorded charges to general and administrative costs in the consolidated statements of operations of $8,131 and $24,660,respectively, with respect to these stock options.

OnJune 30, 2023, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of theBoard of Directors, granted to each of the four non-officer directors of the Company stock options to purchase 10,000 shares (a totalof 40,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $5.88 per share(the closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested,subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model,was determined to be $192,593 ($4.8131 per share), which was charged to operations ratably from July 1, 2023 through June 30, 2025. Duringthe three months ended June 30, 2025 and 2024, the Company recorded charges to general and administrative costs in the consolidated statementsof operations of $23,968 and $24,100, respectively, with respect to these stock options. During the six months ended June 30, 2025 and2024, the Company recorded charges to general and administrative costs in the consolidated statements of operations of $47,672 and $48,068,respectively, with respect to these stock options.

OnSeptember 26, 2023, in connection with the employment agreement entered into with Bas van der Baan, Mr. van der Baan was granted a stockoption to purchase 250,000 shares of the Company’s common stock. The stock option can be exercised on a cashless basis. The stockoption is exercisable for a period of five years at an exercise price of $1.95 per share, which was equal to the closing market priceof the Company’s common stock on the grant date. The stock option initially vested in equal increments quarterly over a three-yearperiod commencing on the last day of each calendar quarter commencing October 1, 2023, subject to continued service. The fair value ofthis stock option, as calculated pursuant to the Black-Scholes option-pricing model, was determined to be $403,066 ($1.612 per share),which was being charged to operations ratably from September 26, 2023 through September 30, 2026. Effective June 16, 2025, in connectionwith an amendment to Mr. van der Baan’s employment agreement (see Note 5), the stock option was deemed fully vested and the remainingunamortized fair value was charged to operations on such date, and the time period for Mr. van der Baan to exercise this stock optionat any time in the future that he is no longer providing services to the Company as a consultant, employee or otherwise was increasedfrom ninety days to one year. During the three months ended June 30, 2025 and 2024, the Company recorded charges to general and administrativecosts in the consolidated statements of operations of $200,805 and $33,345, respectively, with respect to this stock option. During thesix months ended June 30, 2025 and 2024, the Company recorded charges to general and administrative costs in the consolidated statementsof operations of $233,784 and $66,690, respectively, with respect to this stock option.

OnJune 30, 2024, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of theBoard of Directors, granted to each of the four non-officer directors of the Company stock options to purchase 10,000 shares (a totalof 40,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $2.37 per share(the closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested,subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model,was determined to be $73,976 ($1.8494 per share), which is being charged to operations ratably from July 1, 2024 through June 30, 2026.During the three months and six months ended June 30, 2025, the Company recorded charges to general and administrative costs in the consolidatedstatements of operations of $9,220 and $18,340, respectively, with respect to these stock options.

OnJune 30, 2024, the Board of Directors, in conjunction with the Company’s efforts to preserve cash, granted to the four non-officerdirectors of the Company a total of 16,598 stock options to purchase shares of the Company’s common stock, exercisable for a periodof five years at an exercise price of $2.37 per share (the closing market price on the grant date) The stock options were granted inlieu of cash compensation, are exercisable for a period of five years and were immediately vested. The number of stock options grantedto each of the four non-officer directors of the Company was equal to the cash payment such director would otherwise have been entitledto receive for the quarter ended June 30, 2024, divided by their grant date value as determined pursuant to the Black-Scholes option-pricingmodel, and was determined to be $27,500 ($1.6570 per share), which was charged to operations on June 30, 2024, the date on which thestock options were fully vested.

OnJuly 1, 2024, in connection with the consulting agreement with Dr. Jan H.M. Schellens, M.D., Ph.D., Dr. Schellens was granted a stockoption to purchase 15,000 shares of the Company’s common stock. The stock option can be exercised on a cashless basis. The stockoption is exercisable for a period of five years at an exercise e price of $2.39 per share, which was equal to the closing market priceof the Company’s common stock on the grant date. The stock option vested quarterly over a three-year period commencing on the lastday of each calendar quarter commencing September 30, 2024. The fair value of this stock option, as calculated pursuant to the Black-Scholesoption-pricing model, was determined to be $29,074 ($1.9382 per share), which is being charged to operations ratably from July 1, 2024through June 30, 2027. During the three months and six months ended June 30, 2025, the Company recorded charges to general and administrativecosts in the consolidated statements of operations of $2,418 and $4,810, respectively, with respect to this stock option. Effective asof July 31, 2025, the Company agreed to accept the resignation of Dr. Schellens and to terminatehis consulting agreement.

OnSeptember 30, 2024, the Board of Directors, in conjunction with the Company’s efforts to preserve cash, granted to the four non-officerdirectors of the Company a total of 21,217 stock options to purchase shares of the Company’s common stock, exercisable for a periodof five years at an exercise price of $1.87 per share (the closing market price on the grant date) The stock options were granted inlieu of cash compensation, are exercisable for a period of five years and were immediately vested. The number of stock options grantedto each of the four non-officer directors of the Company was equal to the cash payment such director would otherwise have been entitledto receive for the quarter ended September 30, 2024, divided by their quarterly value as determined pursuant to the Black-Scholes option-pricingmodel, and was determined to be $27,500 ($1.2961 per share), which was charged to operations on September 30, 2024, the date on whichthe stock options were fully vested.

OnJanuary 20, 2025, the Board of Directors, in conjunction with the Company’s efforts to preserve cash, granted to the four non-officerdirectors of the Company a total of 16,665 stock options to purchase shares of the Company’s common stock, exercisable for a periodof five years at an exercise price of $2.33 per share (the closing market price on the grant date) The stock options were granted inlieu of cash compensation, are exercisable for a period of five years and were immediately vested. The number of stock options grantedto each of the four non-officer directors of the Company was equal to the cash payment such director would otherwise have been entitledto receive for the quarter ended December 31, 2024, divided by their grant date value as determined pursuant to the Black-Scholes option-pricingmodel, and was determined to be $27,500 ($1.65002 per share). The grant date value of the stock options of $27,500 was accrued at December31, 2024 and charged to operations at that date. During the six months ended June 30, 2025, there was no expense charged to operationswith respect to these stock options.

OnMarch 31, 2025, the Board of Directors, in conjunction with the Company’s efforts to preserve cash, granted to the four non-officerdirectors of the Company a total of 32,181 stock options to purchase shares of the Company’s common stock, exercisable for a periodof five years at an exercise price of $1.21 per share (the closing market price on the grant date) The stock options were granted inlieu of cash compensation, are exercisable for a period of five years and were immediately vested. The number of stock options grantedto each of the four non-officer directors of the Company was equal to the cash payment such director would otherwise have been entitledto receive for the quarter ended March 31, 2025, divided by their grant date value as determined pursuant to the Black-Scholes option-pricingmodel, and was determined to be $27,500 ($0.8546 per share), which was charged to operations on March 31, 2025, the date on which thestock options were fully vested.

OnJune 30, 2025, the Board of Directors, in accordance with the Company’s cash and equity compensation package for members of theBoard of Directors, granted to each of the four non-officer directors of the Company stock options to purchase 10,000 shares (a totalof 40,000 shares) of the Company’s common stock, exercisable for a period of five years at an exercise price of $0.905 per share(the closing market price on the grant date), vesting 12.5% on the last day of each subsequent calendar quarter-end until fully vested,subject to continued service. The fair value of these stock options, as calculated pursuant to the Black-Scholes option-pricing model,was determined to be $28,700 ($0.7175 per share), which is being charged to operations ratably from July 1, 2025 through June 30, 2027.During the three months and six months ended June 30, 2025, the Company did not record a charge to operations with respect to these stockoptions.

OnJune 30, 2025, the Board of Directors, in conjunction with the Company’s efforts to preserve cash, granted to the four non-officerdirectors of the Company a total of 42,648 stock options to purchase shares of the Company’s common stock, exercisable for a periodof five years at an exercise price of $0.905 per share (the closing market price on the grant date) The stock options were granted inlieu of cash compensation, are exercisable for a period of five years and were immediately vested. The number of stock options grantedto each of the four non-officer directors of the Company was equal to the cash payment such director would otherwise have been entitledto receive for the quarter ended June 30, 2025, divided by their grant date value as determined pursuant to the Black-Scholes option-pricingmodel, and was determined to be $27,500 ($0.6448 per share), which was charged to operations on June 30, 2025, the date on which thestock options were fully vested.

GilSchwartzberg, a former director of the Company, died on October 30, 2022. Dr. John S. Kovach, the Chairman of the Board of Directorsand the Company’s President and Chief Executive Officer, and Chief Scientific Officer, died on October 5, 2023, the employmentagreement of the Company’s Chief Medical Officer, Dr. James S. Miser expired on July 31, 2024, the employment agreement of theCompany’s Vice President and Chief Operating Officer, Eric J. Forman, terminated upon his resignation from the Company on December31, 2024, and the consulting agreement of the Company’s Chief Medical Officer, Dr. Jan Schellens, was terminated effective withhis resignation on July 31, 2025. Accordingly, the unvested stock options for each such person ceased vesting effective as of the respectivedates that their services to the Company terminated. Furthermore, the expiration date of all vested stock options owned by each suchperson contractually expire one year from the respective dates that their services to the Company terminated.

Asummary of stock-based compensation costs for the three months and six months ended June 30, 2025 and 2024 is as follows:

	2025		2024		2025		2024
	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2025		2024		2025		2024

Related parties	$	267,999	$	130,691	$	367,737	$	233,618
Non-related parties		—		—		—		—
Total stock-based compensation costs	$	267,999	$	130,691	$	367,737	$	233,618

Asummary of stock option activity, including options issued in the form of warrants, during the six months ended June 30, 2025 is as follows:

	Number of Shares		Weighted Average Exercise Price		Weighted Average Remaining Contractual Life (in Years)

Stock options outstanding at December 31, 2024		613,232	$	12.317
Granted		131,494		1.160
Exercised		—		—
Expired		—		—
Stock options outstanding at June 30, 2025		744,726	$	10.347		2.99

Stock options exercisable at December 31, 2024		409,897	$	17.100
Stock options exercisable at June 30, 2025		669,726	$	11.196		2.87

Totaldeferred compensation expense for the outstanding value of unvested stock options was approximately $91,000 at June 30, 2025, which willbe recognized subsequent to June 30, 2025 over a weighted-average period of approximately 18 months.

AtJune 30, 2025, the outstanding common stock options, including options issued in the form of warrants, are exercisable at the followingprices per common share:

Exercise Prices		Options Outstanding (Shares)		Options Exercisable (Shares)

$	0.905		82,648		42,648
$	1.210		32,181		32,181
$	1.870		21,217		21,217
$	1.950		250,000		250,000
$	2.330		16,665		16,665
$	2.370		56,598		36,598
$	2.390		15,000		5,000
$	5.025		8,750		8,750
$	5.880		40,000		40,000
$	7.400		55,000		55,000
$	20.000		45,000		40,000
$	20.600		20,000		20,000
$	28.000		25,000		25,000
$	30.300		30,000		30,000
$	32.100		10,000		10,000
$	60.000		8,333		8,333
$	71.400		20,000		20,000
$	120.000		8,334		8,334
			744,726		669,726

Basedon the closing fair market value of $0.905 per common share on June 30, 2025, there was no intrinsic value attributed to exercisablebut unexercised common stock options at June 30, 2025.

Outstandingstock options to acquire 75,000 shares of the Company’s common stock had not vested at June 30, 2025.

Uponthe exercise of such stock options, the Company expects to satisfy the related stock obligations through the issuance of authorized butunissued shares of common stock.

7.Income Taxes

Duringthe three months and six months ended June 30, 2025 and 2024, the Company did not record any provision for income taxes, as the Companyincurred losses during such periods. Deferred tax assets and liabilities reflect the net tax effect of temporary differences betweenthe carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The Companyhas recorded a full valuation allowance against its deferred tax assets for all periods presented as the Company currently believes itis more likely than not that the deferred tax assets will not be realized.

8.Commitments and Contingencies

LegalClaims

TheCompany may be subject to legal claims and actions from time to time as part of its business activities. As of June 30, 2025 and December31, 2024, the Company was not subject to any threatened or pending lawsuits, legal claims or legal proceedings.

PrincipalCommitments

ClinicalTrial Agreements

AtJune 30, 2025, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trialmonitoring agreements not yet incurred, as described below, aggregated $524,000, including clinical trial agreements of $293,000 andclinical trial monitoring agreements of $231,000, which, based on current estimates, are currently scheduled to be incurred through approximatelyDecember 31, 2027. The Company’s ability to conduct and fund these contractual commitments is subject to the timely availabilityof sufficient capital to fund such expenditures, as well as any changes in the allocation or reallocation of such funds to the Company’scurrent or future clinical trial programs. The Company expects that the full amount of these expenditures will be incurred only if suchclinical trial programs are conducted as originally designed and their respective enrollments and duration are not modified or reduced.Clinical trial programs, such as the types that the Company is engaged in, can be highly variable and can frequently involve a seriesof changes and modifications over time as clinical data is obtained and analyzed, and is frequently modified, suspended or terminated,in part based on receipt or lack of receipt of an indication of clinical benefit or activity, before the clinical trial endpoint is reached.Accordingly, such contractual commitments as discussed herein should be considered as estimates only based on current clinical assumptionsand conditions and are typically subject to significant modifications and revisions over time.

Thefollowing is a summary of the Company’s ongoing active contractual clinical trials described below as of June 30, 2025:

Schedule of Contractual Clinical Trials

Description of Clinical Trial

Institution

Start Date

Projected End Date

Planned Number of Patients in Trial

Study Objective

Clinical Update

Expected Date of Preliminary Efficacy Signal

NCT No.

Remaining Financial Contractual Commitment

LB-100 combined with dostarlimab in ovarian clear cell carcinoma (Phase 1b/2)

MD Anderson

January 2024

December 2027

Determine the OS of patients with recurrent ovarian clear cell carcinoma

16 patients entered

December 2026

NCT06065462

-0- (1 )

LB-100 combined with atezolizumab in microsatellite stable metastatic colorectal cancer (Phase 1b)

Netherlands Cancer Institute (NKI)

August 2024

December 2026

Determine RP2D with atezolizumab

First patient entered August 2024, in total two patients entered

June 2026

NCT06012734

-0- (1 )

LB-100 combined with doxorubicin in advanced soft tissue sarcoma (Phase 1b)

GEIS

June 2023

Recruitment completed September 2024

Determine MTD and RP2D

Fourteen patients entered

December 2025

NCT05809830

293,000

Total

293,000

(1)	The Company has no financial contractual commitments associated with these clinical trials at June 30, 2025.

NetherlandsCancer Institute. Effective June 10, 2024, the Company entered into a Clinical Trial Agreement with the Netherlands Cancer Institute(“NKI”) (see Note 5) to conduct a Phase 1b clinical trial of the Company’s protein phosphatase inhibitor, LB-100, combinedwith atezolizumab, a PD-L1 inhibitor, the proprietary molecule of F. Hoffman-La Roche Ltd. (“Roche”), for patients with microsatellitestable metastatic colorectal cancer. Under the agreement, the Company will provide its lead compound, LB-100, and under a separate agreementbetween NKI and Roche, Roche will provide atezolizumab and financial support for the clinical trial. The Company has no obligation toand will not provide any reimbursement of clinical trial costs. Pursuant to the agreement and the protocol set forth in the agreement,the clinical trial will be conducted by NKI at NKI’s site in Amsterdam by principal investigator Neeltje Steeghs, MD, PhD, andNKI will be responsible for the recruitment of patients. The agreement provides for the protection of the respective intellectual propertyrights of each of the Company, NKI and Roche.

ThisPhase 1b clinical trial will evaluate safety, optimal dose and preliminary efficacy of LB-100 combined with atezolizumab for the treatmentof patients with metastatic microsatellite stable colorectal cancer. Immunotherapy using monoclonal antibodies like atezolizumab canenhance the body’s immune response against cancer and hinder tumor growth and spread. LB-100 has been found to improve the effectivenessof anticancer drugs in killing cancer cells by inhibiting a protein called PP2A on cell surfaces. Blocking PP2A increases stress signalsin tumor cells expressing the PP2A protein. Accordingly, combining atezolizumab with LB-100 may enhance treatment efficacy for metastaticcolorectal cancer, as cancer cells with heightened stress signals are more vulnerable to immunotherapy.

Thisstudy comprises a dose escalation phase and a dose expansion phase. The objective of the dose escalation phase is to determine the recommendedPhase 2 dose (RP2D) of LB-100 when combined with the standard dosage of atezolizumab. The dose expansion phase will further investigatethe preliminary efficacy, safety, tolerability, and pharmacokinetics/dynamics of the LB-100 and atezolizumab combination. The clinicaltrial opened in August 2024 with the enrollment of the first patient. A total of two patients have been enrolled to date. Patient accrualis expected to take up to 24 months, with a maximum of 37 patients with advanced colorectal cancer to be enrolled in this study.

Theprincipal investigator of the colorectal study testing LB-100 in combination with atezolizumab is currently investigating two SeriousAdverse Events (“SAEs”) observed in the clinical trial. The Investigational Review Board (IRB) of NKI has requested additionalinformation with respect to these SAEs and the study has been paused for enrollment until the IRB’s questions have been satisfactorilyaddressed (see “Specific Risks Associated with the Company’s Business Activities - Serious Adverse Events” below foradditional information).

TheCompany has no financial contractual commitment associated with this clinical trial.

Cityof Hope. Effective January 18, 2021, the Company executed a Clinical Research Support Agreement (the “Agreement”) withthe City of Hope National Medical Center, an NCI-designated comprehensive cancer center, and City of Hope Medical Foundation (collectively,“City of Hope”), to carry out a Phase 1b clinical trial of LB-100, the Company’s first-in-class protein phosphataseinhibitor, combined with an FDA-approved standard regimen for treatment of untreated extensive-stage disease small cell lung cancer (“ED-SCLC”).LB-100 was given in combination with carboplatin, etoposide and atezolizumab, an FDA-approved standard of care regimen, to previouslyuntreated ED-SCLC patients. The LB-100 dose was to be escalated with the standard fixed doses of the 3-drug regimen to reach a recommendedPhase 2 dose (“RP2D”). Patient entry was to be expanded so that a total of 12 patients would be evaluable at the RP2D todetermine the safety of the LB-100 combination and to look for potential therapeutic activity as assessed by objective response rate,duration of overall response, progression-free survival, and overall survival.

Theclinical trial was initiated on March 9, 2021, with patient accrual expected to take approximately two years to complete. Because patientaccrual was slower than expected, effective March 6, 2023, the Company and City of Hope added the Sarah Cannon Research Institute (“SCRI”),Nashville, Tennessee, to the ongoing Phase 1b clinical trial. The Company and City of Hope continued efforts to increase patient accrualby adding additional sites and by modifying the protocol to increase the number of patients eligible for the clinical trial. The impactof these efforts to increase patient accrual and to decrease time to completion was evaluated in subsequent quarters.

Afterevaluating patient accrual through June 30, 2024, the Company and City of Hope agreed to close the clinical trial. Pursuant to the termsof the Agreement, the Company provided notice to City of Hope of the Company’s intent to terminate the Agreement effective as ofJuly 8, 2024. Upon closure, the Company incurred a prorated charge of $207,004 for the cost of patients enrolled to date, which is includedin accounts payable and accrued expenses at June 30, 2025 and December 31, 2024.

Duringthe three months ended June 30, 2025 and 2024, the Company incurred costs of $0 and $78,015, respectively, pursuant to this Agreement.During the six months ended June 30, 2025 and 2024, the Company incurred costs of $0 and $78,015, respectively, pursuant to this Agreement.As of June 30, 2025, total costs of $732,532 had been incurred pursuant to this Agreement.

GEIS.Effective July 31, 2019, the Company entered into a Collaboration Agreement for an Investigator-Initiated Clinical Trial with theSpanish Sarcoma Group (Grupo Español de Investigación en Sarcomas or “GEIS”), Madrid, Spain, to carry out astudy entitled “Randomized phase I/II trial of LB-100 plus doxorubicin vs. doxorubicin alone in first line of advanced soft tissuesarcoma”. The purpose of this clinical trial is to obtain information with respect to the efficacy and safety of LB-100 combinedwith doxorubicin in soft tissue sarcomas. Doxorubicin is the global standard for initial treatment of advanced soft tissue sarcomas (“ASTS”).Doxorubicin alone has been the mainstay of first line treatment of ASTS for over 40 years, with little improvement in survival from addingcytotoxic compounds to or substituting other cytotoxic compounds for doxorubicin. In animal models, LB-100 has consistently enhancedthe anti-tumor activity of doxorubicin without apparent increases in toxicity.

GEIShas a network of referral centers in Spain and across Europe that have an impressive track record of efficiently conducting innovativestudies in ASTS. The Company agreed to provide GEIS with a supply of LB-100 to be utilized in the conduct of this clinical trial, aswell as to provide funding for the clinical trial. The goal is to enter approximately 150 to 170 patients in this clinical trial overa period of two to four years. The Phase 1 portion of the study began in the quarter ended June 30, 2023 to determine the recommendedPhase 2 dose of the combination of doxorubicin and LB-100. As advanced sarcoma is a very aggressive disease, the design of the Phase2 portion of the study assumes a median progression-free survival (“PFS”), no evidence of disease progression or death fromany cause, of 4.5 months in the doxorubicin arm and an alternative median PFS of 7.5 months in the doxorubicin plus LB-100 arm to demonstratea statistically significant decrease in relative risk of progression or death by adding LB-100. There is a planned interim analysis ofthe primary endpoint when approximately 50% of the 102 events required for final analysis is reached.

TheCompany had previously expected that this clinical trial would commence during the quarter ended June 30, 2020. However, during July2020, the Spanish regulatory authority advised the Company that although it had approved the scientific and ethical basis of the protocol,it required that the Company manufacture new inventory of LB-100 under current Spanish pharmaceutical manufacturing standards. Thesestandards were adopted subsequent to the production of the Company’s existing LB-100 inventory.

Inorder to manufacture a new inventory supply of LB-100 for the GEIS clinical trial, the Company engaged a number of vendors to carry outthe multiple tasks needed to make and gain approval of a new clinical product for investigational study in Spain. These tasks includedthe synthesis under good manufacturing practice (GMP) of the active pharmaceutical ingredient (API), with documentation of each of thesteps involved by an independent auditor. The API was then transferred to a vendor that prepares the clinical drug product, also underGMP conditions documented by an independent auditor. The clinical drug product was then sent to a vendor to test for purity and sterility,provide appropriate labels, store the drug, and distribute the drug to the clinical centers for use in the clinical trials. A formalapplication documenting all steps taken to prepare the clinical drug product for clinical use was submitted to the appropriate regulatoryauthorities for review and approval before being used in a clinical trial.

Asof June 30, 2025, this program to provide new inventory of the clinical drug product for the Spanish Sarcoma Group study, and potentiallyfor subsequent multiple trials within the European Union, had cost approximately $1,144,000.

OnOctober 13, 2022, the Company announced that the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentosy Productos Sanitarios or “AEMPS”) had authorized a Phase 1b/randomized Phase 2 study of LB-100, the Company’s leadclinical compound, plus doxorubicin, versus doxorubicin alone, the global standard for initial treatment of ASTS. Consequently, thisclinical trial commenced during the quarter ended June 30, 2023 and is expected to be completed and a report prepared by December 31,2026. In April 2023, GEIS completed its first site initiation visit in preparation for the clinical trial at Fundación JiménezDíaz University Hospital (Madrid). Up to 170 patents will be entered into the clinical trial. The recruitment for the Phase 1bportion of the protocol was extended with two patients and was completed during the quarter ended September 30, 2024. The Company expectsto have data on toxicity and preliminary efficacy from this portion of the clinical trial during the quarter ending December 31, 2025.

Giventhe focus on the combination of LB-100 with immunotherapy in ovarian clear cell carcinoma and colorectal cancer and the availabilityof capital resources, the Company entered into Amendment No. 1 to the Collaboration Agreement effective March 11, 2025 that relievedthe Company of the financial obligation to support the randomized Phase 2 portion of the clinical trial contemplated in the CollaborationAgreement of approximately $3,095,000. As a result, it is uncertain as to whether the Phase 2 portion of this clinical trial will proceed.

TheCompany’s agreement with GEIS provided for various payments based on achieving specific milestones over the term of the agreement.During the three months ended June 30, 2025 and 2024, the Company did not incur any costs pursuant to this agreement. During the sixmonths ended June 30, 2025 and 2024, the Company did not incur any costs pursuant to this agreement. Through June 30, 2025, the Companyhas incurred charges of $685,107 for work done under this agreement through the fourth milestone.

TheCompany’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $293,000for the Phase 1b portion of this clinical trial as of June 30, 2025, which is scheduled to be incurred through December 31, 2025. Asthe work is being conducted in Europe and is paid for in Euros, final costs are subject to foreign currency fluctuations between theUnited States Dollar and the Euro. Such fluctuations are recorded in the consolidated statements of operations as foreign currency gainor loss, as appropriate, and have not been significant.

MDAnderson Cancer Center Clinical Trial. On September 20, 2023, the Company announced an investigator-initiated Phase 1b/2 collaborativeclinical trial to assess whether adding LB-100 to a human programmed death receptor-1 (“PD-1”) blocking antibody of GSK plc(“GSK”), dostarlimab-gxly, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma(“OCCC”). The study objective is to determine the overall survival (“OS”) of patients with OCCC. The clinicaltrial is being sponsored by The University of Texas MD Anderson Cancer Center (“MD Anderson”) and is being conducted at TheUniversity of Texas - MD Anderson Cancer Center. The Company is providing LB-100 and GSK is providing dostarlimab-gxly and financialsupport for the clinical trial. On January 29, 2024, the Company announced the entry of the first patient into this clinical trial. TheCompany currently expects that this clinical trial will be completed by December 31, 2027.

OnFebruary 25, 2025, the Company announced that it has added the Robert H. Lurie Comprehensive Cancer Center (Lurie Cancer Center) of NorthwesternUniversity as a second site in a clinical trial combining the Company’s proprietary compound LB-100 with GSK’s dostarlimabto treat ovarian clear cell cancer. Patient recruitment is underway, and the first patient has been dosed.

ClinicalTrial Monitoring Agreements

MDAnderson Cancer Center Clinical Trial. On May 15, 2024, the Company signed a letter of intent with Theradex to monitor the MD Anderseninvestigator-initiated Phase 1b/2 collaborative clinical trial to assess whether adding LB-100 to a human programmed death receptor-1(“PD-1”) blocking antibody of GSK plc (“GSK”), dostarlimab-gxly, may enhance the effectiveness of immunotherapyin the treatment of ovarian clear cell carcinoma (“OCCC”). On August 19, 2024, the Company signed a work order agreementwith Theradex to monitor the MD Anderson clinical trial. The study oversight is expected to be completed by January 31, 2027.

Costsunder this letter of intent and related work order agreement are estimated to be approximately $95,000. During the three months endedJune 30, 2025 and 2024, the Company incurred costs of $4,614 and $8,228 pursuant to this letter of intent and subsequent work order.During the six months ended June 30, 2025 and 2024, the Company incurred costs of $11,892 and $8,228 pursuant to this letter of intentand subsequent work order. As of June 30, 2025, total costs of $38,655 have been incurred pursuant to this letter of intent and subsequentwork order.

TheCompany’s aggregate commitment pursuant to this letter of intent, less amounts previously paid to date, totaled approximately $57,000as of June 30, 2025, which is expected to be incurred through December 31, 2027.

Cityof Hope. On February 5, 2021, the Company signed a new work order agreement with Theradex to monitor the City of Hope investigator-initiatedclinical trial in small cell lung cancer in accordance with FDA requirements for oversight by the sponsoring party. Costs under thiswork order agreement were estimated to be approximately $335,000. During the three months ended June 30, 2025 and 2024, the Company incurredcosts of $0 and $4,500, respectively, pursuant to this work order. During the six months ended June 30, 2025 and 2024, the Company incurredcosts of $0 and $9,000, respectively, pursuant to this work order. As of June 30, 2025, total costs of $87,823 had been incurred pursuantto this work order agreement.

Asa result of the closure of the Agreement with City of Hope effective July 8, 2024 (see “Clinical Trial Agreements – Cityof Hope” above), the work order agreement with Theradex to monitor this clinical trial was concurrently terminated, although nominaloversight trailing costs subsequent to July 8, 2024 are expected to be incurred relating to the closure of this study.

GEIS.On June 22, 2023, the Company finalized a work order agreement with Theradex, to monitor the GEIS investigator-initiated clinicalPhase I/II randomized trial of LB-100 plus doxorubicin vs. doxorubicin alone in first line of advanced soft tissue sarcoma. The studyoversight is expected to be completed by December 31, 2026.

Costsunder this work order agreement are estimated to be approximately $153,000, with such payments expected to be allocated approximately72% to Theradex for services and approximately 28% for payments for pass-through software costs. During the three months ended June 30,2025 and 2024, the Company incurred costs of $3,750 and $7,203, respectively, pursuant to this work order. During the six months endedJune 30, 2025 and 2024, the Company incurred costs of $7,622 and $12,732, respectively, pursuant to this work order. As of June 30, 2025,total costs of $57,077 have been incurred pursuant to this work order agreement.

TheCompany’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaledapproximately $95,000 as of June 30, 2025, which is expected to be incurred through December 31, 2026.

NetherlandsCancer Institute. On August 27, 2024, the Company finalized a work order agreement with Theradex, to monitor the NKI Phase 1b clinicaltrial of LB-100 combined with atezolizumab, a PD-L1 inhibitor, for patients with microsatellite stable metastatic colorectal cancer.The study oversight was expected to be completed by May 31, 2027.

Costsunder this work order agreement were estimated to be approximately $106,380, with such payments expected to be allocated approximately47% to Theradex for services and approximately 53% for payments for pass-through software costs. During three months and six months endedJune 30, 2025, the Company incurred costs of $4,500 and $9,000, respectively, pursuant to this work order. As of June 30, 2025, totalcosts of $29,191 have been incurred pursuant to this work order agreement.

TheCompany’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaledapproximately $79,000 as of June 30, 2025, which was expected to be incurred through May 31, 2027.

TheCompany was recently notified that the preparations for this clinical trial were suspended and the clinical trial is not expected commence.Accordingly, the Company expects that this agreement will be terminated and the Company will have no further financial commitment orcost.

Patentand License Agreements

NationalInstitute of Health. Effective February 23, 2024, the Company entered into a Patent License Agreement (the “License Agreement”)with the National Institute of Neurological Disorders and Stroke (“NINDS”) and the National Cancer Institute (“NCI”),each an institute or center of the National Institute of Health (“NIH”). Pursuant to the License Agreement, the Company haslicensed on an exclusive basis the NIH’s intellectual property rights claimed for a Cooperative Research and Development Agreement(“CRADA”) subject invention co-developed with the Company, and the licensed field of use, which focuses on promoting anti-canceractivity alone, or in combination with standard anti-cancer drugs. The scope of this clinical research extends to checkpoint inhibitors,immunotherapy, and radiation for the treatment of cancer. The License Agreement is effective, and shall extend, on a licensed product,licensed process, and country basis, until the expiration of the last-to-expire valid claim of the jointly owned licensed patent rightsin each such country in the licensed territory, estimated at twenty years, unless sooner terminated.

TheLicense Agreement contemplates that the Company will seek to work with pharmaceutical companies and clinical trial sites (including comprehensivecancer centers) to initiate clinical trials within timeframes that will meet certain benchmarks. Data from the clinical trials will bethe subject of various regulatory filings for marketing approval in applicable countries in the licensed territories. Subject to thereceipt of marketing approval, the Company would be expected to commercialize the licensed products in markets where regulatory approvalhas been obtained.

TheCompany is obligated to pay the NIH a non-creditable, non-refundable license issue royalty of $50,000 and a first minimum annual royaltywithin sixty days from the effective date of the Agreement. The first minimum annual royalty of $25,643 was prorated from the effectivedate of the License Agreement to the next subsequent January 1. Thereafter, the minimum annual royalty of $30,000 is due each January1 and may be credited against any earned royalties due for sales made in that year. The license issue royalty of $50,000 and the firstminimum annual royalty of $25,643 were paid in April 2024. The second minimum annual royalty for 2025 of $30,000 was paid in December2024 and was included in other prepaid expenses in the consolidated balance sheet at December 31, 2024.

TheCompany is obligated to pay the NIH, on a country-by-country basis, earned royalties of 2% on net sales of each royalty-bearing productand process, subject to reduction by 50% under certain circumstances relating to royalties paid by the Company to third parties, butnot less than 1%. The Company’s obligation to pay earned royalties under the License Agreement commences on the date of the firstcommercial sale of a royalty-bearing product or process and expires on the date on which the last valid claim of the licensed productor licensed process expires in such country.

TheCompany is obligated to pay the NIH benchmark royalties, on a one-time basis, within sixty days from the first achievement of each suchbenchmark. The License Agreement defines four such benchmarks, which the Company is required to pursue based on “commercially reasonableefforts” as defined in the License Agreement, with deadlines of October 1, 2024, 2027, 2029 and 2031, each with a different specifiedbenchmark payment amount payable within thirty days of achieving such benchmark. The October 1, 2024 benchmark of $100,000 was definedas the dosing of the first patient with a licensed product in a Phase 2 clinical study of such licensed product in the licensed fieldsof use. The Company had not commenced a Phase 2 clinical study as of June 30, 2025. The total of all such benchmark payments is $1,225,000.

TheCompany is obligated to provide annual reports to the NIH on its progress toward the development and commercialization of products underthe licensed patents. These reports, due within sixty days following the end of each calendar year, must include updates on researchand development activities, regulatory submissions, manufacturing efforts, sublicensing, and sales initiatives. If any deviations fromthe established commercial development plan or agreed-upon benchmarks occur, the Company is obligated to provide explanation and mayamend the commercial development plan and the benchmarks, which, subject to certain conditions, the NIH shall not unreasonably withhold,condition, or delay approval of any request of the Company to amend the commercial development plan and/or the benchmarks and to extendthe time periods of the benchmarks.

TheCompany is obligated to pay the NIH sublicensing royalties of 5% on sublicensing revenue received for granting each sublicense withinsixty days of receipt of such sublicensing revenue.

Duringthe three months ended June 30, 2025 and 2024, the Company incurred costs of $7,397 and $7,455, respectively, in connection with itsobligations under the License Agreement. During the six months ended June 30, 2025 and 2024, the Company incurred costs of $14,794 and$60,569, respectively, in connection with its obligations under the License Agreement. Such costs when incurred have been included ingeneral and administrative costs in the Company’s consolidated statement of operations. As of June 30, 2025, total costs of $90,438have been incurred pursuant to this agreement. The Company’s aggregate commitment pursuant to this agreement, less amounts previouslypaid to date, totaled approximately $1,765,000 as of June 30, 2025, which is expected to be incurred over approximately the next twentyyears.

OtherSignificant Agreements and Contracts

NDAConsulting Corp. On December 24, 2013, the Company entered into a consulting agreement with NDA Consulting Corp. for consultationand advice in the field of oncology research and drug development. As part of the consulting agreement, NDA also agreed to have its president,Dr. Daniel D. Von Hoff, M.D., serve on the Company’s Scientific Advisory Committee during the term of such consulting agreement.The term of the consulting agreement was for one year and provided for a quarterly cash fee of $4,000. The consulting agreement had beenautomatically renewed for additional one-year terms on its anniversary date, most recently on December 24, 2023, but was subsequentlyterminated by mutual agreement effective September 30, 2024. Consulting and advisory fees charged to operations pursuant to this consultingagreement were $4,000 and $8,000 for the three months and six months ended June 30, 2024, respectively.

BioPharmaWorks.Effective September 14, 2015, the Company entered into a Collaboration Agreement with BioPharmaWorks, pursuant to which the Company engagedBioPharmaWorks to perform certain services for the Company. Those services included, among other things, assisting the Company to commercializeits products and strengthen its patent portfolio; identifying large pharmaceutical companies with a potential interest in the Company’sproduct pipeline; assisting in preparing technical presentations concerning the Company’s products; consultation in drug discoveryand development; and identifying providers and overseeing tasks relating to clinical development of new compounds.

BioPharmaWorkswas founded in 2015 by former Pfizer scientists with extensive multi-disciplinary research and development and drug development experience.The Collaboration Agreement was for an initial term of two years and automatically renews for subsequent annual periods unless terminatedby a party not less than 60 days prior to the expiration of the applicable period. In connection with the Collaboration Agreement, theCompany agreed to pay BioPharmaWorks a monthly fee of $10,000, subject to the right of the Company to pay a negotiated hourly rate inlieu of the monthly fee. Effective March 1, 2024, the compensation payable under the Collaboration Agreement was converted to an hourlyrate structure.

TheCompany recorded charges to operations pursuant to this Collaboration Agreement of $10,800 and $7,200 during the three months ended June30, 2025 and 2024, respectively, which were included in research and development costs in the consolidated statements of operations.The Company recorded charges to operations pursuant to this Collaboration Agreement of $24,800 and $27,200 during the six months endedJune 30, 2025 and 2024, respectively, which were included in research and development costs in the consolidated statements of operations.

NetherlandsCancer Institute. On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands CancerInstitute, Amsterdam (“NKI”) (see Note 5), one of the world’s leading comprehensive cancer centers, and Oncode Institute,Utrecht, a major independent cancer research center, for a term of three years. The Development Collaboration Agreement was subsequentlymodified by Amendment No. 1 thereto.

TheDevelopment Collaboration Agreement is a preclinical study intended to identify the most promising drugs to be combined with LB-100,and potentially LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlyingthe identified combinations. The Company agreed to fund the preclinical study, at an approximate cost of 391,000 Euros and provide asufficient supply of LB-100 to conduct the preclinical study.

OnOctober 3, 2023, the Company entered into Amendment No. 2 to the Development Collaboration Agreement with NKI, which provides for additionalresearch activities, extends the termination date of the Development Collaboration Agreement by two years to October 8, 2026, and added500,000 Euros to the operating budget being funded by the Company.

Duringthe three months ended June 30, 2025 and 2024, the Company incurred charges of $0 and $67,119, respectively, with respect to this agreement,which amounts are included in research and development costs in the Company’s consolidated statements of operations. During thesix months ended June 30, 2025 and 2024, the Company incurred charges of $0 and $134,084, respectively, with respect to this agreement,which amounts are included in research and development costs in the Company’s consolidated statements of operations. As of June30, 2025, total costs of $695,918 have been incurred pursuant to this agreement.

MRIGlobal. As amended, the Company has contracted with MRI Global for stability analysis, storage and distribution of LB-100 for clinicaltrials in the United States. During the three months ended June 30, 2025 and 2024, the Company incurred costs of $6,765 and $5,976, respectively,pursuant to this contract. During the six months ended June 30, 2025 and 2024, the Company incurred costs of $34,857 and $9,870, respectively,pursuant to this contract. As of June 30, 2025, total costs of $375,379 have been incurred pursuant to this contract.

TheCompany’s aggregate commitment pursuant to this contract, less amounts previously paid to date, totaled approximately $90,000 asof June 30, 2025.

SpecificRisks Associated with the Company’s Business Activities

SeriousAdverse Events

TheCompany’s lead drug candidate, LB-100, is currently undergoing various clinical trials, and there is a risk that one or more ofthese trials could be placed on hold by regulatory authorities due to serious adverse events (SAEs) related to the Company’s drugcandidate or to another company’s drug used in combination in one of the Company’s clinical trials. It is possible that theSAEs could be attributable to the Company’s drug candidate and could include, but not be limited to, unexpected severe side effects,treatment-related deaths, or long-term health complications. A dose given could result in non-tolerable adverse events defined as dose-limitingtoxicity (DLT). When two DLTs occur at the same dose-level that dose-level is considered too high and unsafe. Further treatment is onlyallowed at lower dose-levels that have previously been found safe.

Ifan SAE or a pattern of SAEs is observed during the course of a clinical trial involving the Company’s drug candidate, the U.S.Food and Drug Administration (FDA), European Medicines Agency (EMA), or other regulatory authorities may issue a clinical hold, requiringthe Company to pause or discontinue further enrollment and dosing in the Company’s clinical trial. It is also possible that theclinical trial could be terminated. Any of these actions could delay or halt the development of the Company’s drug candidate, increasedevelopment costs, and negatively impact the Company’s ability to ultimately achieve regulatory approval. Additionally, if an SAEis confirmed to be drug-related, the Company may be required to conduct additional studies, modify the study design, or abandon furtherdevelopment of the drug candidate altogether, which could materially impact the Company’s business, financial condition, and prospects.

Theoccurrence of an SAE and any resulting clinical hold could also harm the Company’s reputation with patients, physicians, healthinstitutions, and investors, diminish the Company’s ability to attract clinical trial participants, and damage the Company’sability to interest investors and obtain financing in the future. There can be no assurances that the Company will not experience suchSAEs in the future or that any related clinical hold will be lifted in a timely manner, or at all.

Theprincipal investigator of the colorectal study testing LB-100 in combination with atezolizumab (Roche PD-L1 inhibitor) is currently investigatingtwo SAEs observed in the clinical trial that was launched in August 2024. The Institutional Review Board (the “IRB”) of theNetherlands Cancer Institute (“NKI”) has put the colorectal cancer study on hold. The adverse reactions that developed inthe two patients were dyspnea (shortness of breath) due to lung toxicity possibly or probably related to the combination of LB-100 andatezolizumab in one patient and fever and aphasia possibly or probably related to the combination of LB-100 and atezolizumab in the secondpatient. The patient who developed lung toxicity deceased due to the combination of lung metastases of colorectal cancer and dyspnea.The patient with fever and aphasia fully recovered from the adverse events with supportive medication.

Giventhe identified adverse events in the two patients in the clinical trial, the IRB requested from the principal investigator of the studyat the NKI information as to whether the adverse events could have been caused by the combination of LB-100 and atezolizumab and informationabout the mode of action of the combination of LB-100 and atezolizumab. The principal investigator prepared a response to the IRB detailingthe safety experience with LB-100 given alone and in combination with other cancer drugs, especially doxorubicin and dostarlimab. Doxorubicinis a well-known chemotherapy, and dostarlimab is a well-known immunotherapy of which the mode of action is closely related to that ofatezolizumab.

Thereported adverse events in the colorectal cancer study have not been seen in any other patients thus far treated with LB-100 alone orin combination with other cancer drugs. Through early July 2025, the Company has been informed that a total of 82 patients had receivedor were receiving experimental treatment with LB-100.

InMay 2025, the Company updated the safety overview of LB-100 and delivered the updated version 5.0 of the Investigator’s Brochure(the “IB”), which contains all of the relevant preclinical, clinical and pharmacologic data with respect to the study ofthe LB-100 clinical compound in humans, to the investigators of all ongoing clinical trials. The investigators of the study in colorectalcancer (NCT06012734) submitted a detailed response to the IRB, including the updated IB.The Company is currently awaiting the outcome of the IRB review.

OtherBusiness Risks

Covid-19Virus. The global outbreak of the novel coronavirus (Covid-19) in early 2020 led to disruptions in general economic activities throughoutthe world as businesses and governments implemented broad actions to mitigate this public health crisis. Although the Covid-19 outbreakhas subsided, the extent to which the coronavirus or any other pandemics may reappear and impact the Company’s clinical trial programsand capital raising efforts in the future is uncertain and cannot be predicted.

Inflationand Interest Rate Risk. The Company does not believe that inflation or increasing interest rates have had a material effect on itsoperations to date, other than their impact on the general economy. However, there is a risk that the Company’s operating costscould become subject to inflationary and interest rate pressures in the future, which would have the effect of increasing the Company’soperating costs, and which would put additional stress on the Company’s working capital resources.

SupplyChain Issues. The Company does not currently expect that supply chain issues will have a significant impact on its business activities,including its ongoing clinical trials.

PotentialRecession. There have been some indications that the United States economy may be at risk of entering a recessionary period. Althoughit does not appear likely at this time, an economic recession could impact the general business environment and the capital markets,which could, in turn, affect the Company.

GeopoliticalRisk. The geopolitical landscape poses inherent risks that could significantly impact the operations and financial performance ofthe Company. In the event of a military conflict, supply chain disruptions, geopolitical uncertainties, and economic repercussions mayadversely affect the Company’s ability to conduct research, develop, test and manufacture products, and distribute them globally.This could lead to delays in product development, interruptions in the supply of critical materials, and delays in clinical trials, therebyimpeding the Company’s clinical development and commercialization plans. Furthermore, the impact of a conflict on global financialmarkets may result in increased volatility and uncertainty in the capital markets, thereby affecting the valuation of the Company’spublicly-traded shares. Investor confidence, market sentiment, and access to capital could all be negatively influenced. Such geopoliticalrisks are outside the control of the Company, and the actual effects on the Company’s business, financial condition and resultsof operations may differ from current estimates.

CybersecurityRisks. The Company has established policies and processes for assessing, identifying and managing material risk from cybersecuritythreats, and has integrated these processes into its overall risk management systems and processes. The Company routinely assesses materialrisks from cybersecurity threats, including any potential unauthorized occurrence on or conducted through its information and email systemsthat may result in adverse effects on the confidentiality, integrity, or availability of the Company’s information and email systemsor any information residing therein. The Company conducts periodic risk assessments to identify cybersecurity threats, as well as assessmentsin the event of a material change in the Company’s business practices that may affect information systems that are vulnerable tosuch cybersecurity threats. These risk assessments include identification of reasonably foreseeable internal and external risks, thelikelihood and potential damage that could result from such risks, and the sufficiency of existing policies, procedures, systems andsafeguards in place to manage such risks. The Company has not encountered any cybersecurity challenges to date that have materially impairedits operations or financial condition.

TheCompany is continuing to monitor these matters and will adjust its current business and financing plans as more information becomes available.

9.Subsequent Events

TheCompany performed an evaluation of subsequent events through the date of filing of these consolidated financial statements with the SEC.Other than as described below or elsewhere in the notes to the consolidated financial statements, there were no material subsequent eventswhich affected, or could affect, the amounts or disclosures in the consolidated financial statements.

Saleof Common Stock, Preferred Stock, Pre-Funded Common Stock Purchase Warrants, and Common Stock Purchase Warrants; Exercise of Pre-FundedCommon Stock Purchase Warrants

July2, 2025 Equity Offering:

OnJune 30, 2025, the Company, entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain purchasersnamed therein (the “Purchasers”), pursuant to which the Company agreed to issue and sell, in a private placement (the “Offering”)59,552 shares (the “Common Shares”) of the Company’s Common Stock, par value $0.0001 per share (the “Common Stock”);Pre-Funded Warrants (“Pre-Funded Warrants”) to purchase 2,322,532 shares of Common Stock; common stock warrants (the “CommonStock Warrants”) to purchase 6,355,214 shares of Common Stock; and 3,573,130 shares of the Company’s Series B ConvertiblePreferred Stock (the “Preferred Shares”). Each Preferred Share is convertible into one share of Common Stock, subject tostandard adjustments such as stock splits and stock dividends. The Preferred Shares are non-voting, except that certain actions of theCompany may not be taken except upon approval of holders who own a majority in stated value of the Preferred Shares. The Preferred Sharesbear an 8% per annum cumulative dividend non-compounding and payable at conversion either in cash or, at the holder’s election,in shares of Common Stock valued at the then effective conversion rate. The holders of the Preferred Shares have the right to designatetwo members to the Company’s Board of Directors.

TheCommon Shares, Pre-Funded Warrants, the Preferred Shares, the Common Stock Warrants and the shares of Common Stock underlying the CommonStock Warrants, Pre-Funded Warrants and Preferred Shares have been registered under the Securities Act of 1933, as amended (the “SecuritiesAct”) and were issued in reliance on an exemption from the registration requirements of the Securities Act afforded by Section4(a)(2) thereof. The Company filed a registration statement on Form S-1 (the “Resale Registration Statement”) to cover theresale of the Common Shares and any shares of Common Stock underlying the Pre-Funded Warrants, the Common Stock Warrants, the PlacementAgent Warrants and the Preferred Shares, which was declared effective by the Securities and Exchange Commission on July 15, 2025.

TheOffering was priced at-the-market under Nasdaq rules at $0.8396 per common stock unit, with each unit consisting of one share of commonstock at a price of $0.7146 and one common stock warrant at a price of $0.125 to acquire one share of common stock at an exercise priceof $1.00 per share. The Offering resulted in gross proceeds of $5,050,000 before deducting the placement agent’s fees and relatedoffering expenses of approximately $824,000. The initial Offering closed on July 2, 2025 with the Company receiving gross proceeds ofapproximately $4,050,000. The remaining $1,000,000 of gross proceeds were paid on July 18, 2025 upon the Resale Registration Statementhaving been declared effective.

Pursuantto a Placement Agent Agreement dated as of June 30, 2025, the Company engaged Spartan Capital Securities,LLC (the “Placement Agent”) to act as the Company’s exclusive placement agent in connection with the Offering.The Company paid the Placement Agent a cash fee equal to 8% of the aggregate gross proceeds raised in the Offering, a non-accountableexpense allowance of 1.0% of the aggregate gross proceeds raised in the Offering, and $125,000 for its expenses including legal fees.

Onthe Closing Date, the Company issued to the Placement Agent warrants (the “Placement Agent’s Warrants”) to purchaseup to 315,626 shares of Common Stock, which represented 5% of the Shares and Pre-Funded Warrants sold in the Offering. The PlacementAgent’s Warrants had an exercise price of 125% of the offering price and otherwise had the same terms as the Common Stock Warrants.On July 15, 2025, the Placement Agent’s warrants were exercised on a cashless basis, resulting in the Placement Agent being issued221,690 shares of the Company’s Common Stock.

Duringthe period from July 2, 2025 through August 5, 2025, 658,455 pre-funded warrants exercisable at $0.00001 per share and sold in the privateplacement, were exercised, resulting in the issuance of 658,455 shares of Common Stock.

July8, 2025 Equity Offering:

OnJuly 3, 2025, the Company, entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain purchasersnamed therein (the “Purchasers”), pursuant to which the Company agreed to issue and sell, in a registered direct offering(the “Offering”) 210,675 shares (the “Common Shares”) of the Company’s Common Stock, par value $0.0001per share (the “Common Stock”) and Pre-Funded Warrants (“Pre-Funded Warrants”) to purchase 763,351 shares ofCommon Stock, at an offering price of $1.54 per share.

TheOffering resulted in gross proceeds of $1,500,000 before deducting placement agent’s fees and related offering expenses of $160,000.The Offering closed on July 8, 2025.

Pursuantto a Placement Agent Agreement dated as of July 3, 2025 (the “Placement Agent Agreement”),the Company engaged Spartan Capital Securities, LLC (the “Placement Agent”) to act as the Company’s exclusiveplacement agent in connection with the Offering. The Company paid the Placement Agent a cash fee equal to 8.0% of the aggregate grossproceeds raised in the Offering, and agreed to reimburse the Placement Agent $40,000 for its legal fees.

Duringthe period from July 8, 2025 through August 5, 2025, 654,000 pre-funded warrants exercisable at $0.00001 per share and sold in the directregistered offering, were exercised, resulting in the issuance of 654,000 shares of Common Stock.

Resignationof Certain Directors and Officers; Appointment of New Directors

Asdescribed above, the Company entered into a Securities Purchase Agreement with certain purchasers named therein pursuant to which, amongother things, the Company issued to the purchasers 3,573,190 shares of the Company’s Series B Preferred Stock (the “PreferredShares”). The Certificate of Designation for the Preferred Shares grants to the holders the right to designate two members to theCompany’s Board of Directors (the “Board”), and the holders designated Jason Sawyer and Dr. Michael Holloway as membersof the Board. At a meeting of the Board on July 18, 2025, Mr. Sawyer and Dr. Holloway were appointed as independent members of the Board.

Inconnection with such appointment, Dr. Stephen Forman and Dr. Yun Yen resigned from the Board and were contemporaneously appointed toserve as members of the Company’s Scientific Advisory Committee. Mr. Sawyer will replace Dr. Yen as Chairman of the CompensationCommittee and as a member of the Audit Committee. The compensation of Mr. Sawyer and Dr. Holloway will be determined by the CompensationCommittee of the Board as part of an overall review of the Company’s compensation program for its independent directors.

Effectiveas of July 31, 2025, the Company agreed to accept the resignation of Dr. Jan Schellens, the Company’s Chief Medical Officer, andto terminate his consulting agreement dated as of May 31, 2024, to allow Dr. Schellens to pursue other employment opportunities.

OtherMatters

EffectiveAugust 4, 2025, the Company entered into a Market Awareness Agreement (the “Agreement”) with MicroCap Advisory, LLC for aterm of six months to develop a clear, impactful, and marketable corporate strategy to identify, reach and engage with potential investors.Following the initial 30 day term of the Agreement, either party may terminate it without cause by providing the other party with atleast 15 days prior written notice. This corporate strategy is intended to serve as the foundation for a comprehensive investor communicationsprogram for the Company.

TheAgreement provides for a one-time account set-up fee of $15,000 and a cash fee of $125,000 per month over a period of six months, subjectto increase, depending on news, events, or other opportunities to amplify public awareness, which will be reviewed and approved by bothparties. In addition, the Agreement provides for the issuance of 48,000 shares of the Company’s common stock to MicroCap Advisory,LLC. upon its signing. The Company has agreed to reimburse MicroCap Advisory, LLC for any pre-approved expenses incurred, including analystreports and travel expenses.

ITEM2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Forward-LookingStatements

ThisQuarterly Report on Form 10-Q of Lixte Biotechnology Holdings, Inc. (the “Company”) contains certain forward-looking statementswithin the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. These mightinclude statements regarding the Company’s financial position, business strategy and other plans and objectives for future operations,and assumptions and predictions about future clinical trials and their timing and costs, product demand, supply, manufacturing costs,marketing and pricing factors are all forward-looking statements. These statements are generally accompanied by words such as “intend”,“anticipate”, “believe”, “estimate”, “potential(ly)”, “continue”, “forecast”,“predict”, “plan”, “may”, “will”, “could”, “would”, “should”,“expect” or the negative of such terms or other comparable terminology. The Company believes that the assumptions and expectationsreflected in such forward-looking statements are reasonable, based on information available to it on the date hereof, but the Companycannot provide assurances that these assumptions and expectations will prove to have been correct or that the Company will take any actionthat the Company may presently be planning. These forward-looking statements are inherently subject to known and unknown risks and uncertainties.Actual results or experience may differ materially from those expected, anticipated or implied in the forward-looking statements. Factorsthat could cause or contribute to such differences include, but are not limited to, regulatory policies or changes thereto, availablecash, research and development results, competition from other similar businesses, and market and general economic factors. This discussionshould be read in conjunction with the condensed consolidated financial statements and notes thereto included in Item 1 of this QuarterlyReport on Form 10-Q and the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, including the sectionentitled “Item 1A. Risk Factors”. The Company does not intend to update or revise any forward-looking statements to reflectnew information, future events or otherwise.

Overview

TheCompany’s product pipeline is primarily focused on inhibitors of protein phosphatase 2A, which is used to enhance cytotoxic agents,radiation, immune checkpoint blockers and other cancer therapies. The Company believes that inhibitors of protein phosphatases have significanttherapeutic potential for a broad range of cancers. The Company is focusing on the clinical development of a specific protein phosphataseinhibitor, referred to as LB-100.

TheCompany’s activities are subject to significant risks and uncertainties, including the need for additional capital. The Companyhas not yet commenced any revenue-generating operations, does not have positive cash flows from operations, relies on stock-based compensationfor a substantial portion of employee and consultant compensation, and is dependent on periodic access to equity capital to fund itsoperating requirements.

RecentSignificant Developments

Saleof Common Stock, Preferred Stock, Pre-Funded Common Stock Purchase Warrants, and Common Stock Purchase Warrants

OnJuly 8, 2025, the Company closed a registered direct offering for gross proceeds of $1,500,000, consisting of shares of common stockand pre-funded warrants to purchase shares of common stock.

Informationwith respect to these equity financings is provided at Note 9 to the condensed consolidated financial statements for the three monthsand six months ended June 30, 2025 and 2024 included elsewhere in this document.

Resignationof Certain Directors and Officers; Appointment of New Directors

Effectiveas of July 31, 2025, the Company agreed to accept the resignation of Dr. Jan Schellens, the Company’s Chief Medical Officer, andto terminate his related consulting agreement dated as of May 31, 2024, to allow Dr. Schellens to pursue other employment opportunities.

Summaryof News Release

July9, 2025 –

TheCompany issued a news release announcing that the Medical Journal Nature published findings by a team of physician scientiststhat validate the scientific premise underlying the Company’s ongoing clinical trials for Ovarian and Colorectal cancers

Theteam led by principal investigator Amir Jazaeri, MD, professor of Gynecologic Oncology and Reproductive Medicine at The University ofTexas MD Anderson Cancer Center, studied survival outcomes of Ovarian Clear Cell Carcinoma (OCCC) patients treated with immune checkpointblockade therapy (clinicaltrials.gov identifier: NCT03026062). The study showed that patients having tumors with inactivating mutationsin PPP2R1A — the major scaffold subunit of protein phosphatase 2A (PP2A) — had significantly better overall survival, comparedwith patients who did not have this mutation in their tumors.

Inactivatingmutations in PPP2R1A are known to reduce the enzymatic activity of PP2A, which is the target of the Company’s lead compound LB-100.Tumors with mutations in PPP2R1A were found to have increased the interferon gamma response pathway, which is known to be associatedwith improved immune checkpoint responses.

TheCompany is currently investigating the activity of LB-100 in combination with checkpoint immunotherapy in two clinical trials. The firstis enrolling patients with OCCC, led by Dr. Jazaeri at MD Anderson Cancer Center, and also is open at Northwestern University. In thistrial, the Company is collaborating with GSK to test LB-100 in combination with dostarlimab (anti PD1). In the second trial, at the NetherlandsCancer Institute, the Company is collaborating with Roche to test LB-100 in combination with atezolizumab (anti PDL1) in colon cancerpatients.

GoingConcern

NasdaqCompliance

TheCompany’s common stock and public warrants are traded on the Nasdaq Capital Market under the symbols “LIXT” and “LIXTW”,respectively.

OnJuly 2, 2025, the Company closed a private placement for $5,050,000, consisting of shares of common stock, pre-funded warrants to purchaseshares of common stock, warrants to purchase shares of common stock, and shares of Series B Convertible Preferred Stock, and on July8, 2025, the Company closed a registered direct offering for $1,500,000, consisting of shares of common stock and pre-funded warrantsto purchase shares of common stock.

RecentAccounting Pronouncements

Informationwith respect to recent accounting pronouncements is provided at Note 2 to the condensed consolidated financial statements for the threemonths and six months ended June 30, 2025 and 2024 included elsewhere in this document.

Concentrationof Risk

Informationwith respect to concentration of risk is provided at Note 2 to the condensed consolidated financial statements for the three months andsix months ended June 30, 2025 and 2024 included elsewhere in this document.

CriticalAccounting Policies and Estimates

Thefollowing critical accounting policies affect the more significant judgements and estimates used in the preparation of the Company’sconsolidated financial statements.

Cash

SegmentInformation

TheCompany’s Chief Executive Officer is the Company’s Chief Operating Decision Maker (“CODM”) and evaluates performanceand makes operating decisions about allocating resources based on internal financial data presented on a consolidated basis. Becausethe CODM evaluates financial performance on a consolidated basis, the Company has determined that it operates in a single reportablesegment, which consists of the development of a drug class called Protein Phosphatase 2A inhibitors, and is comprised of the consolidatedfinancial results of the Company. The CODM uses consolidated net income (loss) as the sole measure of segment profit or loss.

InNovember 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07,Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosure. ASU 2023-07 amends the FASB Accounting Standards Codificationto require additional reportable segment disclosures of a public entity by requiring disclosure of significant segment expenses thatare regularly provided to the chief operating decision maker, requiring other new disclosures, and requiring enhanced interim disclosures.ASU 2023-07 requires public entities with a single reportable segment to provide all the disclosures required by ASU 2023-07 and allexisting segment disclosures in Topic 280 on an interim and annual basis. The Company adopted ASU 2023-07 effective January 1, 2024 forthe 2024 annual period, including quarterly periods, on a retrospective basis.

Researchand Development

Patentand Licensing Legal and Filing Fees and Costs

InSeptember 2023, the Company appointed a new President and Chief Executive Officer, who, with the assistance of the Company’s management,Board of Directors and patent legal counsel, conducted a comprehensive review and analysis of the Company’s patent portfolio inorder to implement a program to balance patent prosecution costs with intellectual property protection benefits. As a result of suchreview and analysis, the Company identified certain patent filings that it decided not to continue to support in 2024 and thereafter.In addition, the Company changed patent legal counsel in mid-2024. The Company expects that patent and licensing legal and filing feesand costs will continue to be a significant continuing cost in 2025 and thereafter as the Company continues to manage its patent portfoliorelated to the clinical development of LB-100.

Asa result of such review and analysis, patent and licensing legal and filing fees and costs related to the development and protectionof the Company’s intellectual property, primarily related to LB-100, decreased to $17,303 for the three months ended June 30, 2025,as compared to $63,612 for the three months ended June 30, 2024, a decrease of $46,309, or 72.8%. Patent and licensing legal and filingfees and costs related to the development and protection of the Company’s intellectual property, primarily related to LB-100, decreasedto $73,386 for the six months ended June 30, 2025, as compared to $146,823 for the six months ended June 30, 2024, a decrease of $73,437,or 50.0%.

Adescriptive summary of the patent portfolio for the Company’s most important clinical programs involving the development of LB-100,as well as a detailed listing of each domestic and international patent that has been issued, is presented at “ITEM 1. BUSINESS– Intellectual Property” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024.

Stock-BasedCompensation

Warrants

TheCompany accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’sspecific terms and applicable authoritative guidance in Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilitiesfrom Equity (“ASC 480”), and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether thewarrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whetherthe warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to theCompany’s own common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstanceoutside of the Company’s control, among other conditions for equity classification. The Company has determined that the warrantsissued in the July 2023 equity financing, the February 2025 equity financing, and the July 2025 equity financings meet the requirementsfor equity classification. This assessment, which requires the use of professional judgment, is conducted when the warrants are issuedand at the end each subsequent quarterly period while the warrants are outstanding. For issued or modified warrants that meet all ofthe criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at thetime of issuance. For issued or modified warrants that do not meet all of the criteria for equity classification, the warrants are requiredto be liability-classified and recorded at their initial fair value on the date of issuance and remeasured at fair value at each balancesheet date thereafter. Changes in the estimated fair value of the warrants that are liability-classified are recognized as a non-cashgain or loss in the statement of operations at each balance sheet date. At June 30, 2025 and December 31, 2024, the Company did not haveany liability-classified warrants.

Summaryof Business Activities and Plans

CompanyOverview

TheCompany is a clinical-stage biopharmaceutical company focused on identifying new targets for cancer drug development and developing andcommercializing cancer therapies. The Company’s product pipeline is primarily focused on inhibitors of protein phosphatase 2A,which is used to enhance cytotoxic agents, radiation, immune checkpoint blockers and other cancer therapies. The Company believes thatinhibitors of protein phosphatases have significant therapeutic potential for a broad range of cancers. The Company is focusing on theclinical development of a specific protein phosphatase inhibitor, referred to as LB-100.

TheCompany believes that the mechanism by which LB-100 affects cancer cell growth is different from cancer agents currently approved forclinical use. LB-100 is currently being tested in clinical trials in Ovarian Clear Cell Carcinoma, Metastatic Colon Cancer, and AdvancedSoft Tissue Sarcoma. LB-100 has shown anti-cancer activity in animal models of glioblastoma multiforme, neuroblastoma, and medulloblastoma,all cancers of neural tissue. LB-100 has also been shown to enhance the effectiveness of commonly used anti-cancer drugs in animal modelsof melanoma, breast cancer and sarcoma. The enhancement of anti-cancer activity of these anti-cancer drugs occurs at doses of LB-100that do not significantly increase toxicity in animals. It is therefore hoped that, when combined with standard anti-cancer regimensagainst many tumor types, LB-100 will improve therapeutic benefit.

Asa compound moves through the FDA-approval process, it becomes an increasingly valuable property, but at a cost of additional investmentat each stage. As the potential effectiveness of LB-100 has been documented at the clinical trial level, the Company has allocated resourcesto manage its patent portfolio. The Company’s approach has been to operate with a minimum of overhead, moving compounds forwardas efficiently and inexpensively as possible, and to raise funds to support each of these stages as certain milestones are reached. TheCompany’s longer-term objective is to secure one or more strategic partnerships or licensing agreements with pharmaceutical companieswith major programs in cancer.

SpecificRisks Associated with the Company’s Business Activities

SeriousAdverse Events

ExternalRisks Associated with the Company’s Business Activities

Covid-19Virus. The global outbreak of the novel coronavirus (Covid-19) in early 2020 led to disruptions in general economic activities throughoutthe world as businesses and governments implemented broad actions to mitigate this public health crisis. Although Covid-19 outbreak hassubsided, the extent to which the coronavirus pandemic may reappear and impact the Company’s clinical trial programs and capitalraising efforts in the future is uncertain and cannot be predicted.

SupplyChain Issues. The Company does not currently expect that supply chain issues will have a significant impact on its business activities,including its ongoing clinical trials.

TheCompany is continuing to monitor these matters and will adjust its current business and financing plans as more information becomes available.

Resultsof Operations

AtJune 30, 2025, the Company had not yet commenced any revenue-generating operations, does not have any positive cash flows from operations,and is dependent on its ability to raise equity capital to fund its operating requirements.

TheCompany’s condensed consolidated statements of operations as discussed herein are presented below.

	Three Months Ended						Six Months Ended
	June 30,						June 30,
	2025			2024			2025			2024

Revenues	$	—		$	—		$	—		$	—

Costs and expenses:
Research and development costs		60,648			210,708			152,105			329,772
General and administrative costs		714,161			798,448			1,329,644			1,646,263
Total costs and expenses		774,809			1,009,156			1,481,749			1,976,035
Loss from operations		(774,809	)		(1,009,156	)		(1,481,749	)		(1,976,035	)
Interest income		365			2,233			806			5,092
Interest expense		(1,810	)		(4,154	)		(4,945	)		(11,340	)
Foreign currency gain		581			158			660			42
Net loss	$	(775,673	)	$	(1,010,919	)	$	(1,485,228	)	$	(1,982,241	)

Net loss per common share – basic and diluted	$	(0.29	)	$	(0.45	)	$	(0.57	)	$	(0.88	)

Weighted average common shares outstanding – basic and diluted		2,720,533			2,249,290			2,596,509			2,249,290

ThreeMonths Ended June 30, 2025 and 2024

Revenues.The Company did not have any revenues for the three months ended June 30, 2025 and 2024.

Researchand Development Costs. For the three months ended June 30, 2025, research and development costs were $60,648, which consisted ofclinical and related oversight costs of $11,601, compound maintenance costs of $20,265, regulatory service costs of $1,190, and preclinicalresearch focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $27,592.

Forthe three months ended June 30, 2024, research and development costs were $210,708, which consisted of clinical and related oversightcosts of $97,947, compound maintenance costs of $5,976, regulatory service costs of $1,956, and preclinical research focused on developmentof additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $104,829.

Includedin preclinical research costs for the three months ended June 30, 2025 and 2024 were $0 and $67,119, respectively, of costs paid to theNetherlands Cancer Institute. On October 8, 2021, the Company entered into a Development Collaboration Agreement with the NetherlandsCancer Institute, Amsterdam, one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independentcancer research center, to identify the most promising drugs to be combined with LB-100, and potential LB-100 analogues, to be used totreat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations.

OnOctober 3, 2023, the Company entered into Amendment No. 2 to the Development Collaboration Agreement with the Netherlands Cancer Institute,which provided for additional research activities, extended the termination date of the Development Collaboration Agreement by two yearsto October 8, 2026, and added 500,000 Euros to the operating budget being funded by the Company.

OnOctober 4, 2024, the Company entered into Amendment No. 3 to the Development Collaboration Agreement with NKI, which suspended AmendmentNo. 2 and provided for a new study term of one year commencing upon the dosing of the first patient in the clinical trial at a projectcost of 100,000 Euros (see “Principal Commitments – Other Significant Agreements and Contracts – Netherlands CancerInstitute” below). The Company was recently notified that the preparations for this clinical trial were suspended and the clinicaltrial is not expected commence. Accordingly, the Company expects that this agreement will be terminated and the Company will have nofurther financial commitment or cost.

Researchand development costs decreased by $150,060, or 71.2%, in 2025 as compared to 2024, primarily as a result of a decrease in clinical andrelated oversight costs of $86,346 and preclinical research focused on development of additional novel anti-cancer compounds to add tothe Company’s clinical pipeline of $77,237, offset by an increase in compound maintenance costs of $14,289.

Generaland Administrative Costs. For the three months ended June 30, 2025, general and administrative costs were $714,161, which consistedof the fair value of vested stock options issued to directors and officers of $267,999 (including quarterly director and board committeefees of $27,500 and the acceleration of the vesting of stock options held by Bas van der Baan of $167,460 as a result of the amendmentof his employment contract), patent and licensing legal and filing fees and costs of $17,303, other consulting and professional feesof $206,362, insurance expense of $64,277, officer compensation and related costs of $104,947, licensing and royalties of $7,397, shareholderreporting costs of $7,353, listing fees of $13,250, filing fees of $5,420, investor relations of $11,397, taxes and licenses of $5,056,and other operating costs of $3,400.

Forthe three months ended June 30, 2024, general and administrative costs were $798,448, which consisted of the fair value of vested stockoptions issued to directors and officers of $130,691 (including quarterly director and board committee fees of $27,500), patent and licensinglegal and filing fees and costs of $63,612, other consulting and professional fees of $191,529, insurance expense of $126,873, officercompensation and related costs of $191,971, licensing and royalties of $7,455, shareholder reporting costs of $3,811, listing fees of$12,375, filing fees of $11,319, investor relations of $17,397, taxes and licenses of $15,406, rent of $4,230, conference fees of $14,475,and other operating costs of $7,304.

Generaland administrative costs decreased by $84,287, or 10.6%, in 2025 as compared to 2024, primarily as a result of decreases in patent andlicensing legal and filing fees and costs of $46,309, insurance expense of $62,596, officer compensation and related costs of $87,024,investor relations of $6,000, taxes and licenses of $10,350, filing fees of $5,899, rent of $3,855, and conference fees of $14,475, offsetby increases in fair value of vested stock options issued to directors and officers of $137,308, other consulting and professional feesof $14,833 and shareholder reporting of $3,542.

InterestIncome. For the three months ended June 30, 2025, the Company had interest income of $365, as compared to interest income of $2,233for the three months ended June 30, 2024, related to the investment of the Company’s cash resources.

InterestExpense. For the three months ended June 30, 2025, the Company had interest expense of $1,810, as compared to interest expense of$4,154 for the three months ended June 30, 2024, related to the financing of the premium for the Company’s directors and officersliability insurance policy.

ForeignCurrency Gain. For the three months ended June 30, 2025, the Company had a foreign currency gain of $581, as compared to a foreigncurrency gain of $158 for the three months ended June 30, 2024, from foreign currency transactions.

NetLoss. For the three months ended June 30, 2025, the Company incurred a net loss of $775,673, as compared to a net loss of $1,010,919for the three months ended June 30, 2024.

SixMonths Ended June 30, 2025 and 2024

Revenues.The Company did not have any revenues for the six months ended June 30, 2025 and 2024.

Researchand Development Costs. For the six months ended June 30, 2025, research and development costs were $152,105, which consisted of clinicaland related oversight costs of $27,470, compound maintenance costs of $53,083, regulatory service costs of $1,190, and preclinical researchfocused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $70,362.

Forthe six months ended June 30, 2024, research and development costs were $329,772, which consisted of clinical and related oversight costsof $107,977, compound maintenance costs of $9,870, regulatory service costs of $2,616, and preclinical research focused on developmentof additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $209,309.

Includedin preclinical research costs for the six months ended June 30, 2025 and 2024 were $0 and $134,084, respectively, of costs paid to theNetherlands Cancer Institute, On October 8, 2021, the Company entered into a Development Collaboration Agreement with the NetherlandsCancer Institute, Amsterdam, one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independentcancer research center, to identify the most promising drugs to be combined with LB-100, and potential LB-100 analogues, to be used totreat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations.

Researchand development costs decreased by $177,667, or 53.9%, in 2025 as compared to 2024, primarily as a result of a decrease in clinical andrelated oversight costs of $80,507 and preclinical research focused on development of additional novel anti-cancer compounds to add tothe Company’s clinical pipeline of $138,947, offset by an increase in compound maintenance costs of $43,213.

Generaland Administrative Costs. For the six months ended June 30, 2025, general and administrative costs were $1,329,644, which consistedof the fair value of vested stock options issued to directors and officers of $367,737 (including quarterly director and board committeefees of $55,000 and the acceleration of the vesting of stock options held by Bas van der Baan of $167,460 as a result of the amendmentof his employment contract), patent and licensing legal and filing fees and costs of $73,386, other consulting and professional feesof $439,182, insurance expense of $128,553, officer compensation and related costs of $195,711, cash-based director and board committeefees of $0, licensing and royalties of $14,795, shareholder reporting costs of $12,164, listing fees of $46,500, filing fees of $15,170,investor relations of $22,794, taxes and licenses of $10,113, travel and entertainment of $435, and other operating costs of $5,587,offset by a rent refund of $2,483.

Forthe six months ended June 30, 2024, general and administrative costs were $1,646,263, which consisted of the fair value of vested stockoptions issued to directors and officers of $233,618 (including quarterly director and board committee fees of $27,500), patent and licensinglegal and filing fees and costs of $146,823, other consulting and professional fees of $363,972, insurance expense of $253,727, officercompensation and related costs of $387,589, cash-based director and board committee fees of $38,819, licensing and royalties of $60,569,shareholder reporting costs of $12,749, listing fees of $24,750, filing fees of $19,053, investor relations of $34,794, taxes and licensesof $30,813, rent of $9,881, conference fees of $14,475, travel and entertainment of $9,725, and other operating costs of $4,906.

Generaland administrative costs decreased by $316,619, or 19.2%, in 2025 as compared to 2024, primarily as a result of decreases in patent andlicensing legal and filing fees and costs of $73,437, insurance expense of $125,174, officer compensation and related costs of $191,878,cash-based director and board committee fees of $38,819, licensing and royalties of $45,774, investor relations of $12,000, taxes andlicenses of $20,700, rent of $12,364, conference fees of $14,475, and travel and entertainment of $9,290, offset by increases in thefair value of vested stock options issued to directors and officers of $134,119, other consulting and professional fees of $75,210 andlisting fees of $21,750.

InterestIncome. For the six months ended June 30, 2025, the Company had interest income of $806, as compared to interest income of $5,092for the six months ended June 30, 2024, related to the investment of the Company’s cash resources.

InterestExpense. For the six months ended June 30, 2025, the Company had interest expense of $4,945, as compared to interest expense of $11,340for the six months ended June 30, 2024, related to the financing of the premium for the Company’s directors and officers liabilityinsurance policy.

ForeignCurrency Gain. For the six months ended June 30, 2025, the Company had a foreign currency gain of $660, as compared to a foreigncurrency gain of $42 for the six months ended June 30, 2024, from foreign currency transactions.

NetLoss. For the six months ended June 30, 2025, the Company incurred a net loss of $1,485,228, as compared to a net loss of $1,982,241for the six months ended June 30, 2024.

Liquidityand Capital Resources – June 30, 2025

TheCompany’s condensed consolidated statements of cash flows as discussed herein are as follows:

	Six Months Ended June 30,
	2025			2024

Net cash used in operating activities	$	(1,055,968	)	$	(1,608,266	)
Net cash provided by (used in) investing activities		—			—
Net cash provided by financing activities		904,228			—
Net decrease in cash	$	(151,740	)	$	(1,608,266	)

AtJune 30, 2025, the Company had working capital of $452,630, as compared to working capital of $827,219 at December 31, 2024, reflectinga net decrease in working capital of $374,589 for the six months ended June 30, 2025. The decrease in working capital during the sixmonths ended June 30, 2025 was primarily the result of the level of continuing expenditures related to the Company’s ongoing operations,offset in part by the net proceeds of $914,228 from the sale of securities in a registered direct offering and concurrent private placementthat closed on February 13, 2025. At June 30, 2025, the Company had cash of $887,212 available to fund its operations.

GoingConcern

AtJune 30, 2025, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trialmonitoring agreements not yet incurred aggregated $524,000, which are currently scheduled to be incurred through approximately December31, 2027.

AtJune 30, 2025, the Company did not have any transactions, obligations or relationships that could be considered off-balance sheet arrangements.

OperatingActivities. For the six months ended June 30, 2025, operating activities utilized cash of $1,055,968, as compared to utilizing cashof $1,608,266 for the six months ended June 30, 2024, to fund the Company’s ongoing research and development activities and otheroperating expenses.

InvestingActivities. For the six months ended June 30, 2025 and 2024, the Company did not have any investing activities.

FinancingActivities. For the six months ended June 30, 2025, financing activities consisted of the gross proceeds from the sale of securitiesin the Company’s registered direct offering of $1,050,003, reduced by offering costs of $135,775, and the payment of deferred offeringcosts of $10,000. For the six months ended June 30, 2024, the Company had no financing activities.

PrincipalCommitments

ClinicalTrial Agreements

Thefollowing is a summary of the Company’s ongoing active contractual clinical trials described below as of June 30, 2025:

Description of Clinical Trial

Institution

Start Date

Projected End Date

Planned Number of Patients

in Trial

Study Objective

Clinical Update

Expected

Date of Preliminary Efficacy

Signal

NCT No.

Remaining FinancialContractual Commitment

LB-100 combined with dostarlimab in ovarian clear cell carcinoma (Phase 1b/2)

MD Anderson

January 2024

December 2027

Determine the OS of patients with recurrent ovarian clear cell carcinoma

16 patients entered

December 2026

NCT06065462

-0- (1

)

LB-100 combined with atezolizumab in microsatellite stable metastatic colorectal cancer (Phase 1b)

Netherlands Cancer Institute (NKI)

August 2024

December 2026

Determine RP2D with atezolizumab

First patient entered August 2024, in total two patients entered

June 2026

NCT06012734

-0- (1)

LB-100 combined with doxorubicin in advanced soft tissue sarcoma (Phase 1b)

GEIS

June 2023

Recruitment completed September 2024

Determine MTD and RP2D

Fourteen patients entered

December 2025

NCT05809830

293,000

Total

293,000

(1)	The Company has no financial contractual commitments associated with these clinical trials at June 30, 2025.

TheCompany has no financial contractual commitment associated with this clinical trial.

ClinicalTrial Monitoring Agreements

Patentand License Agreements

TheCompany is obligated to pay the NIH sublicensing royalties of 5% on sublicensing revenue received for granting each sublicense withinsixty days of receipt of such sublicensing revenue.

OtherSignificant Agreements and Contracts

TheCompany’s aggregate commitment pursuant to this contract, less amounts previously paid to date, totaled approximately $90,000 asof June 30, 2025.

Considerationof Strategic Alternatives

TheCompany will continue to evaluate various alternatives to be able to obtain the capital required to fund its operations and businessdevelopment activities, and to maintain its listing on the Nasdaq Capital Market, including merger or acquisition opportunities (includingreverse mergers and acquisitions) and funding transactions which could result in a change in control of the Company. There can be noassurances that the evaluation process will result in the identification of an appropriate transaction, the negotiation and executionof a definitive agreement to effect such a transaction, or that any such transaction will ultimately be approved by the Company’sstockholders and then be consummated. Even if such a strategic transaction is consummated, there can be no assurances that it would enhancestockholder value, and it may result in substantial dilution to existing stockholders. Any potential transaction would be dependent ona number of factors that may be outside of the control of the Company, including, among other things, market conditions, industry trends,the interest of third parties in a potential transaction with the Company, and the availability of appropriate financing for such a transaction.

Trends,Events and Uncertainties

Researchand development of new pharmaceutical compounds by its nature is unpredictable. Although the Company undertakes research and developmentefforts with commercially reasonable diligence, there can be no assurance that the Company’s cash position will be sufficient toenable it to develop any pharmaceutical compound to the extent needed to create future sales to sustain operations as contemplated herein.

Therecan be no assurance that the Company’s pharmaceutical compound will obtain the regulatory approvals and market acceptance to achievesustainable revenues sufficient to support the Company’s operations. Even if the Company is able to generate revenues, there canbe no assurance that the Company will be able to achieve operating profitability or positive operating cash flows. There can be no assurancethat the Company will be able to secure additional financing, to the extent required, on acceptable terms or at all. If cash resourcesare insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to reduce or discontinue itsresearch and development programs, or attempt to obtain funds, if available, through strategic alliances, joint ventures or other transactionstructures that could require the Company to relinquish rights to and/or control of LB-100, or to discontinue operations entirely.

Otherthan as discussed above, the Company is not currently aware of any trends, events or uncertainties that are likely to have a materialeffect on its financial condition in the near term, although it is possible that new trends or events may develop in the future thatcould have a material effect on the Company’s financial condition.

ITEM3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK

Notapplicable.

ITEM4. CONTROLS AND PROCEDURES

DisclosureControls and Procedures

TheCompany’s management is responsible for establishing and maintaining a system of disclosure controls and procedures (as definedin Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)), that is designedto ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act isrecorded, processed, summarized, and reported, within the time periods specified in the rules and forms. Disclosure controls and proceduresinclude, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in thereports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including itsprincipal executive officer and principal financial officer, or persons performing similar functions, as appropriate, to allow timelydecisions regarding required disclosure.

Inaccordance with Exchange Act Rules 13a-15 and 15d-15, an evaluation was completed under the supervision and with the participation ofthe Company’s management, including its Chief Executive Officer and Chief Financial Officer, of the effectiveness of the designand operation of the Company’s disclosure controls and procedures as of June 30, 2025, the end of the most recent fiscal periodcovered by this report. Based on that evaluation, the Company’s management has concluded that the Company’s disclosure controlsand procedures were effective in providing reasonable assurance that information required to be disclosed in the Company’s reportsfiled or submitted under the Exchange Act was recorded, processed, summarized, and reported within the time periods specified in therules and forms of the Securities and Exchange Commission.

Limitationson Effectiveness of Disclosure Controls and Procedures

Indesigning and evaluating disclosure controls and procedures, management recognizes that any controls and procedures, no matter how welldesigned and operated, cannot provide absolute assurance that the objectives of the controls system are met, and no evaluation of controlscan provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected. In addition,the design of disclosure controls and procedures must reflect that there are resource constraints and that management is required toapply judgment in evaluating the benefits of possible controls and procedures relative to their costs.

Changesin Internal Control Over Financial Reporting

TheCompany’s management, including its Chief Executive Officer and Chief Financial Officer, has determined that no change in the Company’sinternal control over financial reporting (as that term is defined in Rules 13(a)-15(f) and 15(d)-15(f) of the Securities Exchange Actof 1934) occurred during the period ended June 30, 2025 that has materially affected, or is reasonably likely to materially affect, theCompany’s internal control over financial reporting.

PARTII - OTHER INFORMATION

ITEM1. LEGAL PROCEEDINGS

TheCompany is not currently subject to any pending or threatened legal actions or claims.

ITEM1A. RISK FACTORS

TheCompany’s business, financial condition, results of operations and cash flows may be impacted by a number of factors, many of whichare beyond the Company’s control, including those set forth in the Company’s Annual Report on Form 10-K for the fiscal yearended December 31, 2024, as filed with the Securities and Exchange Commission on March 24, 2025 (the “2024 Form 10-K”).

TheRisk Factors set forth in the 2024 Form 10-K should be read carefully in connection with evaluating the Company’s business andin connection with the forward-looking statements contained in this Quarterly Report on Form 10-Q. Any of the risks described in the2024 Form 10-K could materially adversely affect the Company’s business, financial condition or future results, and the actualoutcome of matters as to which forward-looking statements are made. These are not the only risks that the Company faces. Additional risksand uncertainties not currently known to the Company or that the Company currently deems to be immaterial also may materially adverselyaffect the Company’s business, financial condition and/or operating results.

Asof the date of the filing of this document, except as disclosed elsewhere in this document, including Note 9. Subsequent Events, therehave been no material changes to the Risk Factors previously disclosed in the Company’s 2024 Form 10-K.

ITEM2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

OnMay 16, 2025, the Company received a notice of conversion with respect to its 350,000 shares of Series A Convertible Preferred Stockoutstanding, These shares of preferred stock were issued to an investor in 2015 and 2016 and were convertible into 72,917 shares of commonstock on such date.

ITEM3. DEFAULTS UPON SENIOR SECURITIES

Notapplicable.

ITEM4. MINE SAFETY DISCLOSURES

Notapplicable.

ITEM5. OTHER INFORMATION

Duringthe six months ended June 30, 2025, no director or officer (as defined in Rule 16a-1(f) under the Exchange Act) of the Company adoptedor terminated a “Rule 10b5-1 trading arrangement”, as such term is defined in Item 408(a) of Regulation S-K.

ITEM6. EXHIBITS

Thefollowing documents are filed as part of this report:

Exhibit Number		Description of Document

4.1		Certificate of Designation of Series B Convertible Preferred Stock dated as of June 30, 2025, filed as Exhibit 4.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on July 3, 2025 and incorporated herein by reference.

10.1		Employment Agreement between the Company and Geordan Pursglove dated as of June 16, 2025, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on June 17, 2025 and incorporated herein by reference.+

10.2		Amendment to Employment Agreement between the Company and Bastiaan van der Baan dated as of June 16, 2025, filed as Exhibit 10.2 to the Company’s Current Report on Form 8-K, as filed with the Securities and Exchange Commission on June 17, 2025 and incorporated herein by reference.+

10.3		Agreement for GSK & Lixte Supported Collaborative Study effective as of September 18, 2023.*

31.1		Officer’s Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*

31.2		Officer’s Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*

32.1		Officer’s Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*

32.2		Officer’s Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*

101.INS		Inline XBRL Instance Document (does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)

101.SCH		Inline XBRL Taxonomy Extension Schema Document

101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB		Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase Document

104		Cover Page Interactive Data File (formatted as Inline XBRL document and included in Exhibit 101.INS)

*Filed herewith.

+Indicates a management contract or any compensatory plan, contract or arrangement.

SIGNATURES

Inaccordance with the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signedon its behalf by the undersigned thereunto duly authorized.

	LIXTE BIOTECHNOLOGY HOLDINGS, INC.
	(Registrant)

Date: August 7, 2025	By:	/s/ GEORDAN PURSGLOVE
		Geordan Pursglove
		Chief Executive Officer
		(Principal Executive Officer)

Date: August 7, 2025	By:	/s/ ROBERT N. WEINGARTEN
		Robert N. Weingarten
		Vice President and Chief Financial Officer
		(Principal Financial and Accounting Officer)

Exhibit10.3

Agreementfor GSK & LIXTE Supported Collaborative Study

Institution:		The University of Texas M. D. Anderson Cancer Center
Investigator:		Amir Jazaeri, MD
GSK Investigational Product:		Dostarlimab
LIXTE Investigational Product:		LB-100
Protocol Number and Title:		219582 “Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma (OCCC) using Dostarlimab and LB-100”
Effective Date:		Last Signature Date

THISSUPPORTED COLLABORATIVE STUDY AGREEMENT (together with Appendices A, B, C, D, E, F and G (collectively “Agreement”)is made as of the Effective Date by and between GlaxoSmithKline LLC, with an office at 1000 Winter Street, Suite 3300,Waltham, MA 02451 (“GSK”), Lixte Biotechnology Holdings, Inc., having offices at 680 E. Colorado Boulevard, Suite180, Pasadena, CA 91101 (“LIXTE”), and The University of Texas M. D. Anderson Cancer Center, a government agencyof the State of Texas and a member institution of the University of Texas System (“System”) having an address at 1515 HolcombeBlvd, Houston, TX., 77030 (“Institution”) GSK, LIXTE and Institution collectively referred to as “Parties”or in the singular “Party,” under the following terms and conditions.

Background. Dr. Amir Jazaeri, MD (“Investigator”), who is employed by the Institution, wishes to conduct at Institution and at Participating Site (as defined in Section 7.3), a clinical study of GSK’s proprietary drug known as Dostarlimab provided by GSK hereunder (the “GSK Investigational Product”) and LIXTE’s proprietary drug known as LB-100 provided by LIXTE hereunder (the “LIXTE Investigational Product”) each provided at no charge to Institution as necessary for the conduct of the clinical study , (collectively the “Investigational Products”) under the protocol number and title specified above (as may be amended from time to time, the “Protocol”) (such clinical study is hereinafter referred to as the “Study”). The Parties are interested in the development of scientific and medical knowledge concerning the Investigational Products and ovarian cancer, and GSK is therefore willing to supply Institution with quantities of the GSK Investigational Product as specified in Appendix A, and as outlined in Schedule 1, Appendix A and LIXTE is willing to supply Institution with the quantities of the LIXTE Investigational Product, as specified in Appendix A (“Delineation of GSK and LIXTE Investigational Product Responsibilities”). GSK is willing to provide funding to support the Study as specified in Section 3.4 below and further described in Appendix B (the “Funding”), however, the Parties agree and acknowledge LIXTE is not providing any funding or compensation to Institution or GSK for conducting the Study under this Agreement. Institution agrees to conduct the Study under the terms and conditions set forth in this Agreement. Insitution is the regulatory sponsor of the Study and is responsible for all sponsor and investigator regulatory obligations for the Study, if and to the extent applicable to the Study and if the Study is not exempt from such regulation. The Parties have identified responsibilities for this Study as indicated in Appendix C (“Task Responsibility Matrix”). Institution will notify GSK and LIXTE promptly in writing of any proposed change of the Investigator. Given that the Investigator is not a legal party to this Agreement, all references in this Agreement that purport to or arguably impose a legal obligation on the Investigator will be deemed to be a legal obligation on Institution, and Institution will be responsible for ensuring that the Investigator complies with such obligation.

Page 1 of 38 Confidential

2.	Compliance with Protocol/Law.

2.1.

Institution will conduct the Study in accordance with (a) the Protocol (attached as Appendix D and acknowledged by the Parties as the confidential information of Institution); (b) this Agreement; (c) all applicable provisions of any and all federal, state and local laws, rules, regulations, orders and guidance relevant to the conduct of the Study including, (i) the United States Federal Food, Drug, and Cosmetic Act, as amended, and the applicable regulations promulgated under it from time to time, the Public Health Service Act, the Anti-Kickback Statute set forth at 42 U.S.C. § 1320a-7b(b), United States Code of Federal Regulations and applicable comparable state laws and regulations; (ii) the United States Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”) and applicable comparable state laws and regulations; and (iii) publications of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use as adopted by the United States Food and Drug Administration (“FDA”), including current Good Clinical Practice (GCP) guidelines. Institution will be the regulatory sponsor of the Study and will fulfill, or cause the fulfillment of, all responsibilities of a regulatory sponsor (including postings on clinicaltrials.gov), if applicable to the Study and if the Study is not exempt from such regulation. If necessary, the Institution has filed or will file, and will maintain, an Investigational New Drug Application (“IND”) authorizing the Study with the FDA. Institution shall obtain and maintain, or shall cause Investigator to obtain and maintain, all other required authorizations for, and reviews of, the Study including approval of the IRB (as defined in Section 5 below) and proper oversight by all other applicable entities (e.g., ethics committees). Institution represents that the Investigator has the necessary licenses and has the expertise, time and resources to perform this Study.

2.2.

Should there be any inconsistency between the Protocol and the terms of this Agreement, the language of this Agreement shall control over the Protocol or any amendments thereto, except that the terms of the Protocol (or any amendments thereto) shall govern with respect to medical, scientific and clinical issues of the Study.

2.3.

The Parties will use reasonable efforts to conduct the Study in adherence with the Anticipated Timelines set out in Appendix E (“Anticipated Timelines”). Any material change, deviation, delay, modification, or reasonably expected delay to the Anticipated Timelines of which a Party becomes aware will be documented in writing to the other Parties for awareness and possible resolution.

3.	GSK & LIXTE Support

3.1.

Investigational Products Supply and Accountability. GSK and LIXTE each agree to provide Institution and Investigator with the quantities of GSK Investigational Product and LIXTE Investigational Product, respectively, as specified in Appendix A. For the avoidance of doubt, Institution and Investigator are performing the Study independently of GSK and LIXTE, and GSK and LIXTE have not determined the design of the Protocol and are not responsible for its implementation. Institution or its authorized designee will: (a) verify receipt of the GSK and LIXTE Investigational Products by signing the appropriate documentation provided by GSK and LIXTE or their respective designee; (b) handle and store all Investigational Products securely and in compliance with all applicable laws, rules and regulations and as specified in the Protocol, the applicable Investigational Products labeling and/or in writing by GSK or LIXTE, as the case may be; (c) be responsible for any additional labeling (e.g., for dispensing the Investigational Products for the Study) in compliance with and as required by applicable laws and the Protocol; (d) maintain complete and accurate records of use and disposition of the Investigational Products; (e) only dispense, or permit to be dispensed, the GSK Investigational Product and LIXTE Investigational Product supplied under this Agreement to Study subjects in accordance with the Protocol; and (f) after completion or early termination of the Study, at GSK’s or LIXTE’s respective expense, (i) return to GSK (or its designee) or destroy (as instructed by GSK) all unused GSK Investigational Product in accordance with the Protocol, applicable laws and regulations, and any reasonable written instructions provided by GSK to Institution, and, in the event of destruction of GSK Investigational Product, provide GSK, upon request, with a certificate/documentation of destruction to GSK’s reasonable satisfaction, and (ii) return to LIXTE (or its designee) or destroy (as instructed by LIXTE) all unused LIXTE Investigational Product in accordance with the Protocol, applicable laws and regulations, and any reasonable written instructions provided by LIXTE to Institution, and, in the event of destruction of LIXTE Investigational Product, provide LIXTE, upon request, with a certificate/documentation of destruction to LIXTE’s reasonable satisfaction. Notwithstanding the foregoing, Institution will have the right to destroy expired Investigational Products after thirty (30) days of the Investigational Products’ respective expiration date, unless otherwise agreed to by the respective Parties. Additionally, Institution and Investigator shall ensure that any Study subject clinical samples collected for purposes of the Study as required by the Protocol to be tested during and in the course of the Study are tested in accordance with the Protocol or are otherwise taken in accordance with standard of care. Investigational Products shall, at all times remain solely under the responsibility and overall control of the Institution until used in the Study, returned or destroyed. Institution and Investigator shall not supply or permit any other person to supply the Investigational Products to any third party, that is, any person who is not participating in the Study as a member of the Study Personnel (defined in Section 7.2 below) or a subject enrolled in the Study. GSK and LIXTE shall supply the GSK and LIXTE Investigational Product only after and as long as the Institution has obtained and holds the necessary authorizations and/or approvals for the Study in accordance with Section 5 below.

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(a)Neither GSK nor LIXTE will be obligated to provide any quantity of the Investigational Products and/or Funding other than as specifiedin Appendix A and Appendix B, respectively, unless such obligation to provide additional Investigational Products and/or Funding is includedin a written amendment to this Agreement signed by Institution, GSK and LIXTE.

(b)GSK & LIXTE will provide Institution and/or Investigator label proofs of such Investigational Products shipments for review, whichare in compliance to FDA criteria, and understand that all Investigational Products should be shipped to Institution in accordance withAppendix G, provided that GSK and LIXTE are provided written details of shipping details for the Participating Sites from the Institutionand/or Investigator so that GSK and LIXTE can ship Investigational Products directly to Participating Sites.

3.2.

Institution will not, and will ensure Investigator does not, and Institution will not (and will ensure Investigator does not) permit any third parties to, modify or reverse engineer, combine with another material, or formulate the Investigational Products or use the Investigational Products, in each case other than specified in this Agreement or the applicable Protocol without GSK’s and LIXTE’s prior written agreement for their respective Investigational Product.

3.3.

Misconduct. If GSK or LIXTE reasonably believes with sufficient evidence there has been any research misconduct in relation to the Study, GSK or LIXTE will inform Institution and the Investigator and Institution will reasonably cooperate, and will cause Investigator to reasonably cooperate, to conduct a thorough investigation into any alleged research and, to the extent permitted by law, provide GSK or LIXTE with any applicable findings and/or outcomes.

3.4.

Funding. GSK agrees to provide the Funding to Institution for the Study as set forth in Appendix B. Institution agrees that the amounts payable or otherwise provided by GSK under this Agreement represent amounts actually and reasonably required to enable the work to be performed by Institution and Investigator in connection with the Study and have not been determined in a manner that takes into account the volume or value of any referrals or business. Institution or its authorized designee will maintain complete and accurate records of the use and disposition of the Funding. Institution represents that any additional funding it may obtain to fund the Study and/or which is used in connection with the Study will not impose any obligations, restrictions and/or conditions on Institution, Investigator and/or any Participating Site or Sub-investigator that may conflict with the rights of GSK and LIXTE (including rights of GSK and LIXTE under Section 13 below and/or the obligations of Institution and Investigator set out in this Agreement).

(i)Institution agrees and acknowledges that the Funding received from GSK will not be used to support any type of medical education programs(e.g., Continuing Medical Education, Independent Medical Education).

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(ii)No services by Institution or Investigator or any payments by GSK to Institution under this Agreement are related to or for any promotionalor marketing activities.

(iii)Institution shall receive Funding from GSK on behalf of the Participating Site(s) and shall ensure that the Participating Site(s) arepromptly and accurately reimbursed for their participation in this Study. GSK shall have no further responsibility to provide any furtherfinancial reimbursement to either Institution or any Participating Site(s) over and above that set out in this Agreement.

3.5.

Declaration of GSK and LIXTE Support. Subject to Section 11 below, Institution agrees to accurately describe GSK’s and LIXTE ‘s support for the Study in accordance with all applicable laws, regulations and institutional or publication policies applicable to the activities authorized by this Agreement. Institution agrees that: (a) all claims that Institution submits for reimbursement to any federal healthcare program or third party payor for any procedure that involves the Funding or that involves any Investigational Products provided by or on behalf of GSK and/or LIXTE at no cost to Institution will accurately reflect the provision of such Funding or supply by or on behalf of GSK and/or LIXTE; and (b) Institution will not seek reimbursement from any federal healthcare program or third party payor for any amounts paid, or Investigational Products supplied, by GSK and/or LIXTE under this Agreement.

4.	Reports, Audits and Use of Study Data and Biological Samples.

4.1.

Reports and Audits. Institution will maintain complete and up-to-date medical and other records relating to the Study and will keep GSK and LIXTE informed of the Study’s results and enrollment status through written reports to be provided monthly or as otherwise reasonably requested by GSK and/or LIXTE. The information to be provided in such reports will include the number of subjects enrolled in the Study and achievement of Study milestones. Subject to Section 11.1 below, Institution and/or Investigator will collect Study Data (as defined in Section 4.2 below) from the Participating Sites and will provide all Study Data (collected by Institution and Participating Sites), suitably de-identified, (as defined in HIPPA), to GSK and LIXTE (within such timeframe as is agreed in writing with GSK and LIXTE) after such Study Data is recorded in the Study database after final database freeze, or at such time that the Investigator provides the Study Data from the Study to a third party to the extent permitted hereunder, or upon termination of this Agreement as provided in Section 14.3, whichever is the earliest date. The Study Data will be provided in such format as GSK and LIXTE may reasonably request. Institution shall cause Investigator to provide each of GSK and LIXTE with a final Study report in the form of a draft manuscript, detailing the methodology, results and containing an analysis of the Study and drawing appropriate conclusions, conforming to International Committee of Medical Journal Editors guidelines and suitable for submission to a peer-reviewed journal within ninety (90) days after completion or early termination of the Study, whichever occurs first, and such manuscript will be submitted to GSK and LIXTE in accordance with Section 13 of this Agreement. At mutually agreeable times during normal administrative business hours and upon advance notice during the Study and for a period of one (1) year after completion of Study, Institution will give GSK and LIXTE and their respective designees access to all records and documentation (however stored) relating to the Study or to the care of Study subjects, in order for GSK and LIXTE to monitor the Study for source document verification and/or audit purposes. Institution and/or Investigator will also make those records and documents available for the purposes of any audit by a regulatory authority and agree not to destroy those records and documents without first giving GSK and LIXTE written notice and the opportunity to store them at GSK’s and/or LIXTE’s expense. Institution will ensure that all transactions under this Agreement are properly and accurately recorded in all material respects on its books and records and each document upon which entries in such books and records are based is complete and accurate in all material respects. Institution will maintain a system of internal accounting controls reasonably designed to ensure that it maintains no off-the-books accounts. GSK’s and/or LIXTE’s access rights under this Agreement shall be subject to GSK’s and/or LIXTE’s compliance, in connection with accessing Institution’s systems or at Institution’s facility, with Institution’s reasonable measures for purposes of confidentiality, safety, and security, and will be further subject to GSK’s and/or LIXTE’s compliance with Institution’s premises rules that are generally applicable to all persons at Institution’s facilities. Should GSK and/or LIXTE utilize one or more third party(s) in exercising its audit or inspection rights in this paragraph, GSK and/or LIXTE will ensure that such party(ies) shall be subject to an obligation of confidentiality consistent with the obligations of confidentiality required of GSK and/or LIXTE hereunder and such third party(ies) shall be subject to any and all conditions upon GSK’s and/or LIXTE’s access rights that are set forth under this Agreement. If GSK and/or LIXTE obtains, learns of, comes in contact with, or otherwise has access to any patient health and medical information in connection with the Study, GSK and/or LIXTE will keep such information confidential and will comply with all applicable laws regarding the confidentiality of such information, and GSK and/or LIXTE will not use or disclose such patient health and medical information in a manner that would violate any applicable law (including HIPAA) if such use or disclosure were made by Institution. References to “business days” in this Agreement means calendar days excluding Saturdays and Sundays and Study site holidays observed by Study site’s administrative staff, and “business hours” will refer to standard administrative work hours (generally between 8:00 am and 5:00 pm local time) on such business days.

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4.2.

Use of Study Data. Institution shall own the Study Data and shall ensure that the Participating Site(s) and all Study Personnel, including Investigator and Sub-investigator(s), assign all right, title and interest in Study Data to Institution (or to Participating Site(s) for further assignment to Institution). Institution hereby grants to GSK, LIXTE, and their respective affiliates a fully sublicensable, royalty-free, fully paid-up, perpetual, irrevocable, transferable, worldwide right and non-exclusive license to use all data and information resulting from the Study, including any and all data and information arising from any analyses of Biological Samples (as defined below) conducted by or on behalf of Institution, Investigator and Sub-investigator(s) in accordance with the Protocol (collectively the “Study Data”), for any and all purposes, including for inclusion in GSK’s and LIXTE’s or their respective affiliates’ patent filings and regulatory submissions for their respective Investigational Products. All other data collected or created pursuant to or prepared in connection with the Protocol other than Study Data, including medical records, laboratory notebooks, and source documents, and all other primary data sources underlying data recorded on the case report forms (CRFs) (collectively “Source Records”) shall remain at Institution as property of Institution and shall be available for inspection in accordance with Section 4.1. Institution shall have the right to publish Study Data only in accordance with Section 12 below and following any such publication Institution shall have the right to use such published Study Data for any purpose. Institution shall then have the right to use any unpublished Study Data only for internal, non-commercial research purposes and/or in connection with Study subject care. Institution discloses the Study Data to GSK and LIXTE in confidence, and GSK and LIXTE should keep the Study Data confidential until the earlier of (i) publication or other public presentation of such Study Data by Institution in accordance with Section 12 of this Agreement, or (ii) twelve (12) months after the conclusion of the Study. Notwithstanding the foregoing, GSK and LIXTE and their respective affiliates may (a) perform analysis of such Study Data as GSK and LIXTE, respectively, deems appropriate, and GSK and LIXTE, respectively, may use such Study Data and analyses as it wishes for its internal purposes, which shall include, without limitation, disclosure to any third parties to the extent that they may be assisting GSK or LIXTE or their respective affiliates with any analysis, subject to that third party agreeing to keep such Study Data and analyses confidential on the same terms as provided herein, and (b), with the consent of the other Parties, not to be unreasonably withheld, include such Study Data in patent filings and regulatory submissions for their respective Investigational Products. Institution and/or Investigator will ensure that GSK and LIXTE are named in the ICF(s) (as defined in Section 5 below) and in the HIPAA authorization form(s) or analogous documents if signed separately from the ICF (“HIPAA Authorization(s)”) (each, a “Consent Document”), as parties to whom Study subjects’ protected health information (as that term is defined in HIPAA) (“PHI”) may be disclosed in connection with the Study, and that such Consent Document(s) will permit GSK, LIXTE and their respective designees access to Study subjects’ PHI and Source Records as may be necessary to audit the Study and to use the Study Data and Biological Samples (defined in Section 4.3 below), including for research and drug development purposes. Subject to Institution’s rights herein to publish Study Data and to use such published Study Data, Institution shall not and shall procure that the Participating Site(s) shall not, give access to the unpublished Study Data to any third party other than GSK (or GSK’s nominees) or LIXTE (or LIXTE’s nominees) during the term of this Agreement and for a period of five (5) years from the date of completion of the Study without the prior written consent of GSK and LIXTE. Institution shall notify all organizations to whom it grants access to the Study Data of its obligations under this Section and shall require such organizations to give similar undertakings for the benefit of GSK and LIXTE. Notwithstanding anything to the contrary herein, GSK and LIXTE shall access, disclose, and use any patient identifiable information provided to it/them or which it/they obtains or comes in contact with under this Agreement only as (1) authorized by an applicable Study subject’s ICF and/or HIPAA authorization; and (2) as permitted by applicable law and Institution’s IRB.

4.3.	Biological Samples.

4.3.1.

Definition. “Biological Samples” means blood, fluid and/or tissue samples collected from Study subjects for purposes of the Study as set forth in the Protocol, and tangible materials directly or indirectly derived from such samples.

4.3.2.

Use of Biological Samples. Institution will collect, retain and/or use Biological Samples only as set forth in the Protocol. Institution and/or Investigator will provide GSK and LIXTE with quantities of Biological Samples as required by the Protocol. GSK and LIXTE may use such Biological Samples as specified in the Protocol and as permitted in the Consent Documents and by applicable law. The Consent Document(s) will permit GSK, LIXTE and their respective affiliates and designees access to Biological Samples, including for research and drug development purposes.

4.3.3.

Stored Biological Samples. Institution and/or Investigator are permitted, at their own expense, to transfer Biological Samples to a licensed biorepository and store the Biological Samples at the licensed biorepository after completion or early termination of the Study (the “Stored Biological Samples”). During the Term of this Agreement, Institution and Investigator may use the Stored Biological Samples as specified in the Protocol and as permitted in the Consent Documents and by applicable law. All uses of Stored Biological Samples and any data or information arising therefrom are subject to the terms of this Agreement.

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4.3.4.

Non-Permitted Use of Stored Biological Samples. Institution and/or Investigator will not use, and will ensure that the Participating Site(s) and other Study Personnel will not use, Biological Samples or Stored Biological Samples for any purpose other than as permitted under this Agreement and the Protocol. In the event that Institution, Participating Site(s) and/or any Study Personnel (including Sub-investigator(s)) and/or Investigator) use Biological Samples or Stored Biological Samples for any purpose other than as permitted under this Agreement or the Protocol (a “Non-Permitted Use”), Institution agrees that GSK shall be the sole and exclusive owner of any and all inventions made or invented (as such term is defined under U.S. Patent Law) in connection with the Non-Permitted Use that are solely related to GSK Confidential Information or GSK’s Investigational Product. Institution agrees that LIXTE shall be the sole and exclusive owner of any and all inventions made or invented (as such term is defined under U.S. Patent Law) in connection with the Non-Permitted Use that are solely related to LIXTE Confidential Information or LIXTE’s Investigational Product. Institution agrees that any and all inventions made or invented (as such term is defined under U.S. Patent Law) in connection with the Non-Permitted Use that are related to both GSK Confidential Information and LIXTE Confidential Information or both of GSK’s and LIXTE’s Investigational Products or that are directed to the combination therapy of the GSK Investigational Product with the LIXTE Investigational Product (“Combined Non-Permitted Use Inventions”) will be the joint property of GSK and LIXTE, and GSK and LIXTE will be the exclusive joint owners of any such Combined Non-Permitted Use Inventions. In the event of any Combined Non-Permitted Use Invention, GSK and LIXTE will negotiate in good faith an agreement that addresses each of GSK’s and LIXTE’s rights and obligations related to such Combined Non-Permitted Use Invention. Institution shall and hereby does assign any and all inventions described above in accordance with the foregoing and made as a result of a Non-Permitted Use to GSK and/or LIXTE (in accordance with the foregoing allocation of ownership) and shall execute and deliver, and shall cause its employees (including Investigator) to execute and deliver, any and all documents, including those for assignment and conveyance to memorialize such ownership of GSK and/or LIXTE in the invention and of all intellectual property rights therein consistent with Section 13 below. Notwithstanding the foregoing, any inventions made or invented by Institution personnel in connection with a Non-Permitted Use that are not owned by GSK and/or LIXTE in accordance with the foregoing shall be solely owned by Institution; provided that, Institution hereby grants to GSK, LIXTE, and their respective affiliates a non-exclusive, fully paid-up, worldwide, perpetual, irrevocable, royalty-free license to use such solely-owned Institution inventions for all purposes. For the avoidance of doubt, if any Participating Site or Sub-investigator is authorized under the Protocol, the Consent Documents and applicable law to use any Biological Samples or Stored Biological Samples, Institution shall ensure that the terms of this Section 4.3.4 are incorporated, mutatis mutandis, in the contract executed by Institution and the Participating Site in accordance with Section 7.4.1, such that GSK and LIXTE receive the same rights, assignments and licenses from Participating Site(s) as GSK and LIXTE would have received if Institution had performed the activities conducted by the Participating Site(s).

Institutional Review Board, Informed Consent Form, Review and Approvals. Initiation of the Study according to the Protocol shall not begin until the relevant Institutional Review Board (“IRB”) approval is obtained at Institution, and at Participating Site(s) for their Study initiation, and GSK and LIXTE have each been informed in writing of such approvals. Before submission to its IRB, Institution shall ensure Investigator supplies GSK and LIXTE with a copy of the informed consent form that is to be signed by all subjects enrolled in the Study (together with any amendments thereto, the “ICF”) for GSK’s and LIXTE ‘s review and approval. If a HIPAA Authorization form that is separate from the ICF will be used for the Study, then Institution shall ensure that Investigator also supplies GSK and LIXTE with a copy of such HIPAA Authorization form for GSK’s and LIXTE’s review and approval including, if applicable, prior to any submission to its IRB. Each Party will cooperate in the amendment of the HIPAA Authorization as may be necessary from time to time to comply with HIPAA to the extent HIPAA applies to such Party, and to ensure that the Study Data may be disclosed to and used by GSK and LIXTE and their respective affiliates and designees for the purposes contemplated by this Agreement and to the extent permitted by the IRB. Institution and/or Investigator shall inform GSK and LIXTE in writing of the IRB’s continuing reviews of the Study promptly after each such review takes place, which shall take place regularly as determined by the IRB of record and applicable law. If a Participating Site’s IRB requires material changes to its ICF and/or HIPAA Authorization that would impact the use of such site’s Study Data, Institution shall ensure that GSK and LIXTE review and approve such changes before that ICF and/or HIPAA Authorization are used at Participating Site.

Protocol and Informed Consent Form Changes. Institution and Investigator shall ensure that the Protocol is submitted to GSK for review and approval and submitted to LIXTE for review and approval. Institution and Investigator will not make any changes to the Protocol or the Consent Documents without first informing GSK and LIXTE of any such change and obtaining the written approval of the IRB, GSK, and LIXTE and, if necessary, making required amendments to the IND. Institution shall ensure that Investigator promptly incorporates into the ICF and Protocol any new core safety data of the Investigational Products provided by GSK and/or LIXTE and to promptly seek or procure approval of the IRB for such revised ICF. Institution, through Investigator, will be responsible for providing GSK and LIXTE with a copy of the final Protocol and Consent Documents approved by the IRB. The Protocol will be considered final after it is approved by the IRB.

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7.	Personnel.

7.1.

Institution and Investigator. Institution represents and certifies that Institution and Investigator have the necessary experience to conduct the Study and Institution is and shall remain throughout the Study, authorized to enter into this Agreement. Investigator will lead and direct the conduct of the Study as principal investigator at Institution.

7.2.

Study Personnel. Study Personnel shall include any individual by way of example, engaged by Institution, Participating Site and/or Investigator who (a) participates in the conduct of the Study; (b) is privy to information related to the scientific elements of this Study that have the potential to give rise to any Inventions (defined in Section 13.2 below) or rights related to such Inventions; and/or (c) is privy to any other Confidential Information (defined below) and such other individuals set forth in the Study proposal and Study budget provided to GSK and/or LIXTE (“Study Personnel”). For avoidance of doubt, Sub-investigator(s) (as defined in Section 7.4 below) is/are Study Personnel.

7.3.

Qualified Personnel. Institution will ensure (and will cause each Participating Site (as defined below) to ensure, with respect to each Sub-investigator) that all Study Personnel conducting the Study (a) are qualified to conduct the Study; (b) are subject to the terms under this Agreement or substantially similar to those outlined under this Agreement; (c) are obligated in writing or by the terms of their employment to give ownership to Institution (or to the applicable Participating Site, in the case of each Sub-investigator) of any rights they might have in the results of their work; and (d) will do so under the direction of the Investigator at Institution and under the direction of the Sub-investigator(s) at their respective Participating Site(s), if applicable, with the prior approval and ongoing oversight of relevant competent governmental authorities. “Participating Site” means such other institution and its facilities where a Sub-Investigator is employed or under contract with, as Institution may invite to participate, or which from time to time participates, in the Study and references to “Participating Sites” shall be to any one or more of such institutions.

7.4.

Sub-investigators. Each of GSK and LIXTE hereby consents to the engagement by Institution of external sub-investigator(s) (“Sub-investigator(s)”) and their Participating Sites to participate in the conduct of the Study. Institution and Investigator will provide GSK and LIXTE with a list of the Sub-investigator (s) and their Participating Site(s) promptly upon request. Institution and Investigator will notify GSK and LIXTE promptly in writing of any subsequent changes to such list and will submit IRB approval letters to GSK and LIXTE promptly for any additional Participating Site(s). In addition, Institution will:

7.4.1.

contract with Participating Site(s) with respect to the Study under the terms and conditions consistent with the terms under this Agreement such that GSK and LIXTE receive the same rights from Participating Site(s) as GSK and LIXTE would have received if Institution had performed the activities conducted by the Participating Site(s), including under the terms relating to confidentiality, intellectual property (including the assignments, licenses and option rights under Section 4.3.4 and Section 13), ICFs, publication, insurance, safety reporting, GSK’s and LIXTE’s right to audit, drug accountability, Biological Samples and Stored Biological Samples and compliance with laws and regulations;

7.4.2.

ensure that the Sub-investigator(s) assign to their Participating Site(s), and shall cause the Participating Site(s) to assign to Institution, any and all an obligation to assign any intellectual property made by Sub-investigator(s) as a result of their participation in the conduct of the Study in order for Institution to fulfill its obligations to GSK and LIXTE regarding inventions under Section 4.3.4 and Inventions (as defined in Section 13.2 below) under this Agreement; and

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7.4.3.

be solely responsible for providing shipping information to GSK and LIXTE for their distribution of Investigational Products to Sub-investigator(s), and for providing accountability information from Sub-investigator(s) for Investigational Products to the extent permitted by applicable law.

No Conflicts or Debarment. Institution will ensure that Institution, its trustees, officers and directors, Investigator, Participating Site(s), Sub-investigator(s), and Study Personnel: (a) are under no contractual or other obligation or restriction that is inconsistent with Institution’s and Investigator’s performance of or obligations under this Agreement; and (b) do not have a financial or other interest in GSK or LIXTE or the outcome of the Study that might interfere with their independent judgment. Institution will ensure that Institution, the Study Personnel and any and all Participating Site(s), and GSK and LIXTE, respectively, will ensure that it and any of its personnel who access Institution’s facilities, premises, or systems under this Agreement have not been, and are not under consideration to be (i) debarred from providing services pursuant to Section 306 of the United States Federal Food, Drug and Cosmetic Act 21 U.S.C. § 335a; (ii) excluded, debarred or suspended from, or otherwise ineligible to participate in any federal or state health care programs or federal procurement or non-procurement programs (as that term is defined in 42 U.S.C. § 1320a-7b(f)); (iii) disqualified by any government or regulatory agencies from performing specific services, and are not subject to a pending disqualification proceeding; or (iv) convicted of a criminal offense related to the provision of health care items or services, or under investigation or subject to any such action that is pending. During the Study and for a period of two (2) years following completion or early termination of the Study, each Party will notify the other Parties promptly if such party or any of its personnel involved in the conduct of the Study (or in the case of GSK and LIXTE any of their respective personnel who access Institution’s facilities, premises, or systems under this Agreement) are subject to the foregoing, or if any action, suit, claim, investigation, or proceeding relating to the foregoing is pending, or to the best of such Party’s knowledge, is threatened.

9.	Safety Data Reporting.

9.1.	Reporting. Institution is responsible for reporting all serious adverse events (SAE) (as defined in the Protocol) to regulatory authorities in the appropriate time frame as required by applicable law and as outlined in the Protocol and Appendix F.

9.2.

Institution will promptly notify GSK and LIXTE of all SAEs, Special Situations (as defined in the Protocol), pregnancies, exposure via breastfeeding, and other safety information in accordance with the timelines and procedures specified in the Protocol and Appendix F. In addition, Institution will reasonably obtain and provide follow-up information as available, to GSK and LIXTE upon request.

9.3.	Follow-Up Information. Institution and Investigator will assist GSK and LIXTE in investigating any SAE and will provide any follow-up information reasonably requested by GSK and LIXTE and consistent with applicable law.

9.4.	Regulatory Reporting. Reporting an SAE to GSK and LIXTE does not relieve Investigator or Institution of responsibility for reporting it to the applicable regulatory authority, if and as required.

10.

Communications with Regulatory Agencies. Institution shall ensure that the Investigator will

(a)notify GSK and LIXTE of any communications from or to any regulatory authority received by the Investigator, including any safety reports,having an impact on the Investigational Products and the Study;

(b)include GSK and LIXTE in any discussions (other than immaterial discussions, such as for scheduling purposes) or meetings between Investigatorand the FDA and/or other regulatory agencies regarding the Study unless prohibited by law or such regulatory agencies;

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(c)supply GSK and LIXTE with a copy of any correspondence from the FDA received by the Investigator regarding the Study, including any IND,approval letter, and any other IND-related correspondence unless prohibited by law or such regulatory agencies; and inform GSK and LIXTE(and provide a copy to GSK and LIXTE, if written) of (i) any communications from a regulatory and/or government agency regarding theperformance of the Study, unless prohibited by law or such regulatory agencies; (ii)any request made by a regulatory authority to auditor inspect the Study Data/Participating Site(s) and/or the activities of the Investigator, relating to the Study; and/or (iii) the withdrawalor amendment of any IRB approval/regulatory authorization relating to the Study;

(d) allow GSK and LIXTE a reasonable opportunity to comment on any correspondence being sent by the Investigator for submission to theFDA regarding the Study, including any submitted IND and IND annual reports.

Notwithstandinganything to the contrary herein, Institution does not provide GSK or LIXTE any records maintained by Institution’s InvestigationalNew Drug Office or any access thereto.

11.

Confidentiality.

11.1.

Medical Confidentiality. The Parties agree to adhere to the principles of medical confidentiality in relation to Study Subjects involved in the Study. Institution shall not and shall ensure that the Investigator does not disclose to GSK or LIXTE or their affiliates PHI pertaining to Study subjects, unless required directly or indirectly for the purpose of adverse event reporting or otherwise requested by GSK and/or LIXTE in conformance with the relevant Consent Document. GSK and LIXTE shall not disclose the identity of Study subjects disclosed to it/them for this purpose to third parties without prior written consent of the Study subject, except in accordance with the requirements of all applicable laws and statutes relating to data protection.

11.2.

“Confidential Information” refers to non-public information of any kind related to the Study which is disclosed by GSK or LIXTE (each, a “Discloser”) to another Party (“Recipient”) for purposes of conducting the Study, either directly or indirectly, in writing, orally or by inspection of tangible objects, including, without limitation, information and materials regarding the Discloser’s technology, products, product candidates, research and development activities, results, compound designs or structures, manufacturing or other processes or methods, know-how, inventions or other intellectual property, the existence or content of licenses, the existence, status or content of licensing or collaboration negotiations, other agreements with third parties, information regarding facilities and financial and other business information, in each case whether or not identified or marked as “confidential” (if, by the nature of the information, it would reasonably constitute proprietary or confidential information) and as such are disclosed or made available to the Recipient. Discloser’s Confidential Information may also include information obtained by Discloser from its collaborators, customers, suppliers, vendors and other third parties who have entrusted their confidential information to Discloser. During the Study and for a period of seven (7) years after the termination or expiration of this Agreement, each Recipient agrees not to (a) publish, disseminate or otherwise disclose, deliver or make available the Confidential Information of any Discloser to any third party other than competent governmental authorities, Sub-investigator(s), Participating Site(s), other Study Personnel and GSK’s affiliates or designees (in the case of GSK’s Confidential Information) and LIXTE ‘s affiliates or designees (in the case of LIXTE’s Confidential Information), and then only for the purpose of conducting the Study; or (b) make use of any Confidential Information other than in the conduct of the Study or as permitted under this Agreement.

11.3.

Exceptions to Confidential Information. The obligations of nondisclosure and limited use do not apply with respect to any of the Confidential Information that:

11.3.1.

is or becomes public knowledge through no breach of this Agreement by Recipient;

11.3.2.

is disclosed to Recipient by a third party entitled to disclose such information without an obligation of confidentiality to Discloser;

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11.3.3.

is already known to Recipient prior to disclosure hereunder, or is independently developed by Recipient without use of Discloser’s Confidential Information, as shown by Recipient’s written records or competent documentation;

11.3.4.

is necessary to obtain IRB approval of Study or required to be included in the written information summary provided to Study subject(s) and/or informed consent form or as necessary to be disclosed to a Study subject or potential subject in the informed consent process;

11.3.5.

is released with the prior written consent of the Discloser; or

11.3.6.

is required to support the medical care of a Study subject.

11.4.

Recipient may disclose the Discloser’s Confidential Information to the extent that it is required to be produced pursuant to a requirement of applicable law, IRB, government agency, an order of a court of competent jurisdiction, or a facially valid administrative, Congressional, or other subpoena, provided that subject to the requirement, order, or subpoena the Discloser is notified if legally permissible and Recipient cooperates with Discloser’s efforts to limit the scope of the information to be provided or to obtain an order protecting the information from public disclosure. To the extent allowed under applicable law, Discloser may seek to limit the scope of such disclosure and/or seek to obtain a protective order. Recipient will disclose only the minimum amount of Confidential Information necessary to comply with such requirement, law, subpoena or court order as advised by Recipient’s legal counsel.

11.5.

Upon Discloser’s written request, Recipient agrees to return all Confidential Information supplied to it by Discloser, at Discloser’s expense, pursuant to this Agreement except that Recipient may retain an archival copy of such Confidential Information in a secure location for purposes of identifying and satisfying its obligations and exercising its rights under this Agreement.

11.6.

Any Party may disclose the existence and terms of this Agreement as and to the extent necessary to ensure compliance with applicable Federal, State and Institutional policies, regulations, and laws, and GSK and LIXTE may disclose the existence and terms of this Agreement to their respective actual or prospective licensees, sublicensees, collaborators, strategic partners and/or acquirers under confidentiality terms at least as stringent as those hereunder (but of commercially reasonable duration).

11.7.

Institution agrees to not provide GSK’s Confidential Information to LIXTE and to not provide LIXTE’s Confidential Information to GSK without GSK’s and LIXTE’s respective written consent. Notwithstanding the foregoing, to the extent either GSK or LIXTE receives Confidential Information of the other in connection with this Agreement, the obligations of non-use and non-disclosure under this Section 11 will apply to it with respect to such Confidential Information of the other Party.

12.

Publication.

12.1.

GSK and LIXTE recognise that Institution and the Investigator intend that results of scientific interest arising from the Study will be appropriately published and disseminated. Institution and/or Investigator may publish or disclose the results of the Study; provided, that (a) a copy of any proposed disclosure, including any publication, abstract, manuscript, note, slides, oral presentation, poster, or any other document or material whether in written, electronic or printed form and, where publication is intended to be verbal presentation only, any other copy of the intended script, oral presentation, or poster that reports all or parts (interim or final) of the results of the Study or Study progress, is given to GSK and LIXTE for review at least thirty (30) days prior to the date of submission for publication (including abstracts) or of public disclosure; (b) if requested by GSK in writing during such review period, any reference to GSK’s Confidential Information is deleted, and if requested by LIXTE in writing during such review period, any reference to LIXTE’s Confidential Information is deleted; and (c) Institution and/or Investigator defer publication or disclosure for up to an additional sixty (60) days from the time GSK and/or LIXTE notifies Institution and/or Investigator in writing during such review period that GSK and/or LIXTE (i) desires patent application(s) to be filed on any Invention described in the proposed disclosure or (ii) desires to take any other measures as GSK or LIXTE considers necessary to establish, register, protect and/or preserve any intellectual property relating to the GSK Investigational Product and/or LIXTE Investigational Product. Institution and Investigator will ensure that any publication or public disclosure of the results of the Study proposed by a Sub-investigator(s) is/are made in accordance with this Section 12.

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12.2.

Institution and/or Investigator agrees that all reasonable comments made by GSK or LIXTE in relation to a proposed publication by Institution and/or Investigator will be reasonably considered for incorporation by Institution and/or Investigator into the publication. Institution and/or Investigator shall ensure that any of GSK’s Confidential Information is removed from the proposed publication and any of LIXTE’s Confidential Information is removed from the proposed publication.

13.

Intellectual Property.

13.1.

Pre-Existing Intellectual Property. It is expressly agreed that no Party transfers to another Party by operation of this Agreement any patent right, copyright, or other proprietary or property right of any kind any Party owns as of the Effective Date. Nothing herein is intended to grant to any Party any license or other rights in and to such pre-existing or independently developed intellectual property of another Party, except for Institution’s limited right to use the Investigational Products, LIXTE Confidential Information, and GSK Confidential Information solely for the purposes of conducting the Study.

13.2.

Inventions/Investigational Product Inventions. “Inventions” means any inventions, discoveries, know-how, and improvements (including new uses and improvements of the Investigational Products), and all intellectual property rights therein, whether or not protectable under patent or other intellectual property law, that are made or invented by Institution personnel, Investigator, Study Personnel (alone or with others), or any Participating Site(s) personnel, or Sub-investigator(s), (a) during and resulting from performance of the Study or the use of the GSK Investigational Product and/or the LIXTE Investigational Product; or (b) through the use of GSK’s Confidential Information and/or LIXTE’s Confidential Information under this Agreement during the Term of this Agreement and during the secrecy period described in Section 11.2 above. Each Party agrees that:

13.2.1any Invention that incorporates, is based on, refers to or relates solely to GSK Confidential Information or solely to the GSK InvestigationalProduct, or the modification, use or manufacture thereof, (including Inventions that generically encompass within their scope the GSKInvestigational Product, or Inventions relating to the use of the GSK Investigational Product), including any Invention that involvesidentification or use of biomarkers related to the safety, efficacy, or use of the GSK Investigational Product, but excluding CombinedTherapy Inventions (as defined in Section 13.2.3 below) (“GSK Investigational Product Inventions”) shall be promptlydisclosed by Institution to GSK in writing (and Institution shall ensure that any GSK Investigational Product Invention is promptly disclosedto Institution by all Study Personnel and Participating Site(s)) and shall be the sole and exclusive property of GSK. Institution shallassign and does hereby assign to GSK all right, title, and interest in the United States and throughout the world to all GSK InvestigationalProduct Inventions (and, for the avoidance of doubt, Institution shall ensure that all Study Personnel, including Investigator and Sub-investigator(s),have assigned to Institution or Participating Site(s), as applicable, (and that Participating Site(s) have assigned to Institution) allright, title, and interest in the United States and throughout the world to all GSK Investigational Product Inventions). As agreed solelybetween GSK and LIXTE and without any obligation on the part of Institution, LIXTE will have no right and license to Study Data generatedfrom the use of and related solely to GSK’s Investigational Product (for clarity, not in combination with LIXTE’s InvestigationalProduct) or GSK Confidential Information, without GSK’s written consent.

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13.2.2any Invention that incorporates, is based on, refers to or relates solely to LIXTE Confidential Information or solely to the LIXTE InvestigationalProduct, or the modification, use or manufacture thereof, (including Inventions that generically encompass within their scope the LIXTEInvestigational Product, or Inventions relating to the use of the LIXTE Investigational Product), including any Invention that involvesidentification or use of biomarkers related to the safety, efficacy, or use of the LIXTE Investigational Product, but excluding CombinedTherapy Inventions (“LIXTE Investigational Product Inventions”) shall be promptly disclosed by Institution to LIXTEin writing (and Institution shall ensure that any LIXTE Investigational Product Invention is promptly disclosed to Institution by allStudy Personnel and Participating Site(s)) and shall be the sole and exclusive property of LIXTE. Institution shall assign and does herebyassign to LIXTE all right, title, and interest in the United States and throughout the world to all LIXTE Investigational Product Inventions(and, for the avoidance of doubt, Institution shall ensure that all Study Personnel, including Investigator and Sub-investigator(s),have assigned to Institution or Participating Site(s), as applicable, (and that Participating Site(s) have assigned to Institution) allright, title, and interest in the United States and throughout the world to all LIXTE Investigational Product Inventions). As agreedsolely between GSK and LIXTE and without any obligation on the part of Institution, GSK will have no right and license to Study Datagenerated from the use of and related solely to LIXTE’s Investigational Product (for clarity, not in combination with GSK’sInvestigational Product) or LIXTE’s Confidential Information without LIXTE’s written consent.

13.2.3any Invention that relates to both GSK Confidential Information and LIXTE Confidential Information or to both the GSK InvestigationalProduct (or the modification, use or manufacture thereof) and the LIXTE Investigational Product (or the modification, use or manufacturethereof) as a combination therapy (“Combined Therapy Inventions”) will:

(i)be promptly disclosed by Institution to both GSK and LIXTE in writing (and Institution shall ensure that any Combined Therapy Inventionis promptly disclosed to Institution by all Study Personnel and Participating Site(s)); and

(ii)shall be the joint property of GSK and LIXTE, and GSK and LIXTE shall be the exclusive joint owners of Combined Therapy Inventions. Institutionshall assign and does hereby assign to GSK and LIXTE jointly all right, title, and interest in the United States and throughout the worldto all Combined Therapy Inventions (and, for the avoidance of doubt, Institution shall ensure that all Study Personnel, including Investigatorand Sub-investigator(s), have assigned to Institution or Participating Site(s), as applicable, (and that Participating Site(s) have assignedto Institution) all right, title, and interest in the United States and throughout the world to all Combined Therapy Inventions). Inthe event of any Combined Therapy Invention, GSK and LIXTE will negotiate in good faith an agreement that addresses each of GSK’sand LIXTE’s rights and obligations related to such Combined Therapy Invention.

13.3.

Institution will, and will cause Study Personnel (including Investigator), and will ensure that all Participating Site(s) will, and will cause the relevant Sub-investigator(s), to:

(a)reasonably cooperate in the preparation of applications or registrations for patent rights and other proprietary protection for any andall patentable or protectable GSK Investigational Product Inventions, LIXTE Investigational Product Inventions, and Combined TherapyInventions all in the name of (i) GSK for GSK Investigational Product Inventions, (ii) LIXTE for LIXTE Investigational Product Inventions,and (iii) GSK and LIXTE jointly for Combined Therapy Inventions, at

(x)GSK’s cost and expense for GSK Investigational Product Inventions;

(y)LIXTE’ cost and expense for LIXTE Investigational Product Inventions; and

(z)GSK’s and LIXTE’s cost and expense on a 50%/50% basis for Combined Therapy Inventions; and

(b)execute and deliver all requested applications, assignments, and other documents and take such other measures as GSK and/or LIXTE reasonablyrequests, that are necessary in order to perfect GSK’s and LIXTE’s respective rights in GSK Investigational Product Inventions,LIXTE Investigational Product Inventions, and Combined Therapy Inventions.

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13.4.

Other Inventions. Inventions (as defined in Section 13.2) that are not GSK Investigational Product Inventions, LIXTE Investigational Product Inventions or Combined Therapy Inventions (the “Other Inventions”) shall be owned in accordance with inventorship as determined under U.S. Patent Law.

13.5.

License and Options. In the event Institution has an ownership interest in any Other Invention, Institution, on behalf of itself, all Participating Site(s), Investigator and all other Study Personnel (including each Sub-investigator(s)), hereby grants to each of GSK and LIXTE and their respective affiliates a non-exclusive, fully paid-up, worldwide, perpetual, royalty-free, irrevocable license to use Other Inventions for all purposes. In addition, Institution, on behalf of itself, all Participating Site(s), Investigator and all other Study Personnel (including each Sub-investigator(s)), hereby grants to each of GSK and LIXTE a first option to obtain a co-exclusive (exclusive to GSK and LIXTE) perpetual, irrevocable, transferable, royalty-bearing and sublicensable (through multiple tiers) license (“Co-Exclusive License”) to Institution’s, Investigator’s, Study Personnel’s or any Participating Site’s or Sub-investigator’s, interest in any Other Inventions to make, use and sell (and otherwise research, develop and commercialize) those inventions or any products that are covered by patent rights that claim or include those inventions. GSK’s and LIXTE’s Co-Exclusive License option may be exercised with respect to an Other Invention by notice in writing from GSK and/or LIXTE to each of the other Parties, at any time during a period of one-hundred & twenty (120) days (the “Option Period”) after the full written disclosure to GSK and LIXTE by Institution of each such Other Invention. Upon GSK and LIXTE both exercising their Co-Exclusive License with regard to any particular Other Invention, Institution, LIXTE and GSK will negotiate in good faith in an attempt to reach a license agreement satisfactory to all Parties (the “Negotiation Period”). Unless extended by the written consent of all of the Parties, the Option Period and the Negotiation Period shall not exceed two-hundred & forty (240) days in the aggregate. If either GSK or LIXTE declines to exercise the Co-Exclusive License option during an Option Period, then GSK or LIXTE, as the case may be, may exercise the Co-Exclusive License option alone which may result in an exclusive license to such Party. In the event that an Option Period lapses or, including any extensions, terminates, Institution may enter into negotiations to enter into a non-exclusive license agreement with a third party without further obligation to GSK or LIXTE under this Agreement with regard to Institution’s interest in such Other Inventions; provided, however, that the terms offered to a third party are not more favorable than last offered to GSK or LIXTE and provided further that the non-exclusive licenses to GSK and LIXTE will remain in full force and effect.

13.6.

Notwithstanding anything to the contrary, Institution will retain a non-exclusive, royalty-free license to internally use any Invention to which Institution’s personnel or any Participating Site’s personnel makes an inventive contribution for Institution’s research, academic and patient care purposes, which Institution can sublicense only to the contributing Participating Site for such Participating Site’s research, academic and patient care purposes.

14.

Term and Termination; Completion.

14.1	Term. This Agreement is effective as of the Effective Date and will continue in effect through completion of the Study, unless earlier terminated pursuant to this Section 14 (“Term”).

14.2	Termination. This Agreement may be terminated by any Party without cause upon thirty (30) days prior written notice to the other Parties. This Agreement may be terminated by any Party (a) immediately upon written notice to the other Parties if necessary to protect the safety, health or welfare of subjects enrolled in the Study or upon withdrawal of regulatory authorization for the Study; or (b) for a breach of a material provision hereof by a Party, which breach is not cured within thirty (30) days following receipt of written notice thereof; or (c) immediately upon written notice to the other Parties if Investigator is no longer able (for whatever reason) to act as Investigator and no replacement mutually acceptable to Institution, GSK and LIXTE can be found; or (d) if a Party becomes insolvent, or if an order is made or a resolution is passed for its winding up (except voluntarily for the purpose of solvent amalgamation or reconstruction), or if an administrator, administrative receiver or receiver is appointed over the whole or any part of its assets, or if it makes any arrangement with its creditors. Additionally, GSK or LIXTE shall be entitled to terminate this Agreement immediately on written notice to Institution and the other Party if Institution fails to perform its obligations in accordance with Section 17 below. Except for payment due to the Institution as detailed in this Agreement, including but not limited to Section 14.3 below and further set out in Appendix B, Institution shall have no claim against GSK or LIXTE for compensation for any loss of whatever nature by virtue of the termination of this Agreement in accordance with this Section 14.2.

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14.3	Effect of Termination/Completion of Study. Upon either an early termination under Section 14.2 or completion of the Study, (a) this Agreement will terminate; (b) Investigator will immediately stop enrolling subjects into the Study and determine the appropriate manner to cease conducting Study procedures and administration of the Investigational Products to subjects already entered into the Study; (c) Institution will provide GSK with a reconciliation of Study costs against budget as set forth in Appendix B; (d) Institution and/or Investigator will provide a copy of all Study Data to GSK and LIXTE and will return to GSK all of GSK’s Confidential Information and return to LIXTE all of LIXTE’s Confidential Information, except that Institution may retain one archival copy of each of GSK Confidential Information and LIXTE Confidential Information solely for purposes of determining future compliance with the terms of this Agreement and as necessary for legal, regulatory, compliance, or insurance purposes; (e) to the extent GSK and/or LIXTE received Confidential Information of another Party in connection with this Agreement, each of GSK and/or LIXTE, as applicable, will return the Confidential Information to the owning Party; and (f) GSK shall pay Institution all such amounts incurred or obligated by Institution in accordance with milestones as set out in Appendix B at the effective date of such termination.

14.4	Survival. No expiration or termination of this Agreement will release the Parties from their rights and obligations accrued prior to the effective date of expiration or termination. The rights and duties under Sections 3.1(f) (Investigational Products Supply and Accountability); 3.5 (Declaration of GSK and LIXTE Support); 4 (Reports, Audits and Use of Study Data and Biological Samples); 8 (No Conflicts or Debarment) (for the period of time set forth therein); 9 (Safety Data Reporting); 10 (Communications with Regulatory Agencies); 11 (Confidentiality) (for the period of time set forth therein), 12 (Publication), 13 (Intellectual Property); 14.3 (Effects of Termination); 14.4 (Survival); 15 (Indemnification, Remedies, Insurance and Study Subject Injury); 17.2 (Antibribery) and 18 (Miscellaneous) will survive the termination of this Agreement.

15.

Indemnification, Remedies, Insurance and Study Subject Injury.

15.1.

Indemnification by GSK. GSK will indemnify, defend and hold harmless Institution, System, and their Regents, directors, officers, employees (including Investigator), agents, Participating Site(s) and Sub-investigator(s), and any other third parties engaged at their discretion, (collectively, the “Institution Indemnitees”) and LIXTE, its directors, officers, employees and agents (collectively, the “LIXTE Indemnitees”) against any third party claims, including losses, liabilities, damages, claims, costs, charges, expenses and reasonable attorney’s fees for defending those claims (each, a “Claim”) to the extent a Claim arises out of or relates to (i) the personal injury (including death) or property damage arising out of or connected with GSK’s failure to manufacture and provide the GSK Investigational Product in accordance with current Good Manufacturing Practices (“GMP”), (ii) the use by GSK of the results of the Study, and (iii) the activities to be carried out by GSK under this Agreement. GSK’s obligations under this Section 15.1 will not apply to the extent that a Claim is indemnifiable by LIXTE or Institution under Section 15.2 or Section 15.3, respectively, or arises out of or relates to: (a) an Institution Indemnitee’s or a LIXTE Indemnitee’s respective (i) negligence, gross negligence or willful misconduct, or (ii) failure to adhere to the terms of this Agreement or any reasonable written instructions from GSK or its designee; or (b) an Institution Indemnitee’s (1) failure to conduct the Study in accordance with applicable laws or regulations, or (2) failure to adhere to the terms of the Protocol or any reasonable written instructions from GSK or its designees; or (c) any materials, equipment, device and/or drug products used in the Study that are not manufactured or provided by GSK.

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15.2.

Indemnification by LIXTE. LIXTE will indemnify, defend, and hold harmless and the Institution Indemnitees and GSK, its directors, officers, employees and agents (collectively, the “GSK Indemnitees”) against any Claim to the extent such Claim arises out of or relates to (i) the personal injury (including death) or property damage arising out of or connected with LIXTE’s failure to manufacture and provide the LIXTE Investigational Product in accordance with GMP, (ii) the use by LIXTE of the results of the Study, and (iii) the activities to be carried out by LIXTE under this Agreement. LIXTE’s obligations under this Section 15.2 will not apply to the extent that a Claim is indemnifiable by GSK or Institution under Section 15.1 or Section 15.3, respectively, or arises out of or relates to: (a) an Institution Indemnitee’s or a GSK Indemnitee’s respective (i) negligence, gross negligence or willful misconduct, or (ii) failure to adhere to the terms of this Agreement or any reasonable written instructions from LIXTE or its designee; or (b) an Institution Indemnitee’s (1) failure to conduct the Study in accordance with applicable laws or regulations; or (2) failure to adhere to the terms of the Protocol or any reasonable written instructions from LIXTE or its designees; or (c) any materials, equipment, device and/or drug products used in the Study that are not manufactured or provided by LIXTE.

15.3.

Indemnification by Institution. To the extent authorized under the Constitution and the laws of the State of Texas, Institution will indemnify, defend, and hold harmless the GSK Indemnitees and the LIXTE Indemnitees against any Claim to the extent such Claim arises out of or relates to (a) the performance of the Study by Institution or any Institution Indemnitees; or (b) any Institution Indemnitee’s: (i) negligence, gross negligence or willful misconduct, (ii) failure to adhere to the terms of the Protocol, this Agreement, or any reasonable written instructions from GSK or LIXTE or their respective designees, or (iii) failure to conduct the Study in accordance with applicable laws or regulations; provided, however, that deviations from the Protocol for health and safety reasons shall not constitute: failure to follow to the terms of the Protocol, negligence or willful misconduct by an Institution Indemnitee or a breach of this Agreement by an Institution Indemnitee. Institution’s obligations under this Section 15.3 will not apply to the extent that a Claim is indemnifiable by GSK or LIXTE under Section 15.1 or Section 15.2, respectively, or arises out of or relates to the negligence, gross negligence, or willful misconduct of GSK Indemnitees, LIXTE Indemnitees, or any person other than an Institution Indemnitee.

15.4.

Indemnification Procedure. A Party (the “indemnified Party”) must use reasonable efforts to notify the indemnifying Party within thirty (30) days of receipt of any Claim for which such indemnifying Party might be liable under Section 15.1, 15.2, or 15.3, as the case may be; provided, however, the failure to promptly notify the indemnifying Party shall not relieve the indemnifying Party of its indemnification obligations unless the indemnifying Party is materially adversely affected by such failure. The indemnifying Party will have the sole right to defend, negotiate, and settle such Claim; provided, however, such settlements shall not require the indemnified Party to contribute to the settlement, admit fault or require the indemnified Party to change its operations or business practices, without the indemnified Party’s written consent. The indemnified Party will be entitled to participate in the defense of such matter and to employ counsel at its expense to assist in such defense; provided, however, that the indemnifying Party will have final decision-making authority regarding all aspects of the defense of the Claim. The indemnified Party seeking indemnification will provide the indemnifying Party with such information and assistance as the indemnifying Party may reasonably request, at the expense of the indemnifying Party. No indemnified Party will be responsible or bound by any settlement of any Claim or suit made without its prior written consent; provided, however, that the indemnified Party will not unreasonably withhold such consent. This Section 15 is subject to the statutory duties of the Texas Attorney General.

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15.5.

Remedies. Institution agrees that (a) GSK and LIXTE may be irreparably injured by an impending or existing breach of this Agreement; (b) money damages may not be an adequate remedy for any such breach; and (c) GSK and LIXTE will be entitled to seek equitable relief, including injunctive relief and specific performance, without having to post a bond, as a remedy for any such breach. The provisions of this Section 15.5 are not intended to be exclusive and are without prejudice to the rights of GSK and/or LIXTE to seek any other right or remedy that it may have under this Agreement or otherwise.

15.6.

Insurance. Each member of The University of Texas System is self-insured pursuant to The University of Texas Professional Medical Liability Benefit Plan under the authority of Chapter 59, Texas Education Code. Institution has and will maintain in force during the Term of this Agreement adequate insurance or financial resources to cover its indemnification obligations. Upon written request, Institution will provide written evidence of self-insurance or financial resources.

15.7.

Study-Related Injury. If a Study subject is injured or becomes ill as a result of participating in the Study, Institution shall ensure that the Study subject has access to medical treatment necessary to treat such injury or illness. This Agreement does not obligate any of the Parties to provide medical treatment, except to the extent required by applicable law, nor does this Agreement obligate any Party to provide reimbursement for medical treatment if a Study subject requires medical treatment for physical illness or injury sustained as a direct result of the treatment of such Study subject in accordance with this Agreement and the Protocol.

15.8.

Mitigation. Nothing in this Agreement shall relieve any party from its duty under applicable law to mitigate any loss or damage incurred by it as a result of any matter giving rise to a Claim.

16.

Security Breaches and Data Privacy

16.1	Notification of Data Security Breaches. The Parties agree to notify each other in accordance with the below, without undue delay after discovery of a Security Breach (as defined below) and awareness that such Security Breach relates to this Agreement.

(i)

Notice of a Security Breach to GSK, will be sent via e-mail to csir@gsk.com.

Noticeof a Security Breach to LIXTE, will be sent via e-mail to: info@lixte.com

Noticeof a Security Breach to Institution will be sent to: PrivacyCompliance@mdanderson.org

witha follow-up to: The University of Texas M. D. Anderson Cancer Center, Institutional Compliance Office, Unit 1640, P.O. Box 301407,Houston, Texas 77230-1407, Attn: Privacy Officer, Fax No. 713-563-4324.

(ii)

In the course of notification to each other, the Parties will provide, as feasible, sufficient information for the Parties to jointly assess the Security Breach and, to the extent a Party or the Parties may be subject to an applicable legal requirement regarding disclosure to a competent governmental authority, make any required notification to any government authority within the timeline required by applicable laws. Such information may include, but is not necessarily limited to:

(a)

The nature of the Security Breach, the categories and approximate number of data subjects and records;

(b)

The likely consequences of the Security Breach, in so far as consequences are able to be determined;

(c)

Any measures taken to address or mitigate the incident.

(iii)

Following a breach of PHI, the Party (or Parties) who bear the regulatory duty to determine whether a Security Breach occurred will decide on the basis of all available information and applicable laws if the Security Breach will be considered a reportable Security Breach and arrange for notification to data subjects and/or government authorities, if required by applicable laws. Where the Parties decide that notification is required by applicable laws, the Party responsible for providing such notification under applicable data privacy laws shall be responsible for providing such notification.

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(iv)

Assistance in event of Security Breach. In the event of a Security Breach relating to the personal information of another Party’s personnel and/or GSK’s or LIXTE’s Confidential Information collected or received by a Party under this Agreement, each Party agrees to assist and fully cooperate with the other Party with respect to any internal or external investigation through the provision of access to information, employees, interviews, materials, databases, or any and all other items required to fully investigate and resolve any such incidents and provide information necessary to enable required notifications. The breached Party agrees to take such remedial actions as the Parties mutually agree is warranted. Notwithstanding the foregoing, the Parties will each comply with HIPAA, to the extent applicable, with regards to any breach that involves PHI.

(v)

No Party shall disclose, without the other Parties’ prior written approval, any information related to the suspected Security Breach to any third party other than a vendor hired to investigate/mitigate such Security Breach and bound by confidentiality obligations, except as required by applicable laws.

(vi)

“Security Breach” means any actual or suspected breach of security leading to the accidental or unlawful destruction, disclosure of, or access to, the Confidential Information or personal data of another Party’s personnel, as applicable, of any Party.

17.

Anti-bribery and Corruption

17.1

Institution shall comply, and shall ensure Investigator complies, fully at all times with all applicable laws and regulations, including but not limited to anti-corruption laws, and that it has not, and covenants that it will not, in connection with the performance of this Agreement, directly or indirectly, make, promise, authorize, ratify or offer to make, or take any act in furtherance of any payment or transfer of anything of value for the purpose of influencing, inducing or rewarding any act, omission or decision to secure an improper advantage; or improperly assisting it or GSK or LIXTE in obtaining or retaining business, or in any way with the purpose or effect of public or commercial bribery, and warrants that it has taken reasonable measures to prevent subcontractors, agents or any other third parties, including Participating Site(s) and Sub-investigator(s), subject to its control or determining influence, from doing so. For the avoidance of doubt this includes facilitating payments, which are unofficial, improper, small payments or gifts offered or made to government officials to secure or expedite a routine or necessary action to which we are legally entitled.

17.2

Institution agrees that in the event that GSK or LIXTE believes that there has been a possible violation of the terms of this Section 17, GSK or LIXTE may make full disclosure of such belief and related information at any time and for any reason to any competent government bodies and their agencies, and, subject to the confidentiality obligations herein and with respect to any PHI, to the extent permitted by any applicable Consent Document and applicable law, to whomever GSK or LIXTE determines in good faith has a legitimate need to know.

18.

Miscellaneous.

18.1

Independent Contractor. Institution, including Investigator, is an independent contractor and, as such, none of Institution, Institution’s employees, or Investigator will be entitled to any benefits applicable to employees of GSK and/or LIXTE. No Party is authorized or empowered to act as agent for any other Party for any purpose under this Agreement and will not, on behalf of another Party, enter into any contract, warranty or representation as to any matter herein. No Party will be bound by the acts or conduct of any other Party. Nothing in this Agreement and no action taken by the Parties under this Agreement shall constitute a partnership, association or other co-operative entity between any of the Parties or make any Party the agent of any other Party for any purpose.

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18.2

Use of Names; Publicity. Except to the extent required by applicable law or regulation or the rules of any stock exchange or listing agency, no Party will use the name of another Party in any form of advertising, promotion, social media or publicity or in any press release, without the prior written consent of that other Party. Institution agrees and will ensure that Study Personnel agree not to answer third party inquiries regarding the Study or the Investigational Products from financial analysts other than pursuant to a requirement of applicable law, IRB, government agency, an order of a court of competent jurisdiction, or a facially valid administrative, Congressional, or other subpoena and only in accordance with Section 11.4.

18.3

Sponsorship. Institution agrees that GSK or LIXTE will not be listed as the sponsor of the Study in any documentation related to the Study and will ensure that GSK or LIXTE is not identified as the sponsor for regulatory purposes nor referenced to have assumed any sponsor responsibilities for this Study.

18.4

Certain Disclosures and Transparency. Institution acknowledges that GSK and its affiliates and LIXTE and its affiliates are required to abide by applicable federal and state disclosure laws and GSK transparency policies governing their activities including providing reports to the government and to the public concerning financial or other relationships with healthcare providers and healthcare organizations. Institution agrees that GSK and its affiliates and LIXTE and its affiliates may, in their sole discretion, disclose information about this Agreement and about the Study as required by law, including relating to any transfers of value pursuant to this Agreement. Institution agrees to supply information reasonably requested by GSK and LIXTE for disclosure purposes, other than information that Institution previously provided to GSK. To the extent that Institution is independently obligated to disclose specific information concerning the Study, including relating to transfers of value from GSK or its affiliates pursuant to this Agreement, Institution will make timely and accurate required disclosures. Institution hereby represents that Investigator is aware of the possibility of such disclosure.

(i)GSKs disclosure link is as follows: “https://www.gsk.com/en-gb/responsibility/ethical-standards/engaging-with-healthcare-professionals/#Disclosures”

18.5

Assignment; Subcontracting. Except as expressly provided in this Agreement, Institution may not assign, delegate or transfer its obligations under this Agreement, in whole or in part, without the prior written consent of GSK and LIXTE, and any attempted assignment, delegation or transfer by Institution without such consent will be void. GSK and LIXTE may each, respectively, assign, delegate or transfer this Agreement to an affiliate or in connection with the acquisition, licensing, sale or purchase of any or all of its interests or its Investigational Product or its business or assets to which this Agreement relates, in whole or in part, without the consent of the other Parties; however, each of GSK and LIXTE will, as the case may be, provide notice to the other Parties if it assigns this Agreement. No assignment, delegation or transfer will relieve any Party of the performance of any accrued obligation that such Party may then have under this Agreement. With GSK’s and LIXTE’s prior written consent in each instance, Institution may subcontract the performance of certain of its activities under this Agreement to qualified third parties other than Sub-investigator(s) and Participating Site(s); provided, that (a) such permitted third parties perform such activities in a manner consistent with the terms and conditions in this Agreement; (b) Institution causes such permitted third parties to be bound by and comply with the terms of this Agreement, as applicable, including the obligations described in Section 7.4 above; (c) Institution remains liable for Institution’s obligations under this Agreement regardless of any delegations to such permitted third parties; and (d) other than as disclosed to GSK and LIXTE in writing, neither Investigator nor any Sub-investigator has any direct or indirect financial interest in any such permitted third parties. For the avoidance of doubt, and notwithstanding anything to the contrary herein, all permitted third parties used to perform the Study will be considered Study Personnel under this Agreement.

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18.6

Notice. All notices must be in writing and sent to the address for the recipient set forth below or at such other address as the recipient may specify in writing under this procedure. All notices must be given (a) by personal delivery, with receipt acknowledged; or (b) prepaid certified or registered mail, return receipt requested; or (c) by prepaid recognized express delivery service. Notices will be effective upon receipt or at a later date stated in the notice.

	If to GSK:	GSK LLC
		1000 Winter Street, Suite 3300, Waltham, MA 02451
		Attn: Tyler Lockard
		Email: external.research@gsk.com; Fax: +1.339.309.5112

		With a copy to:
		GSK LLC, Marc Harris, Contracting
		1250 South Collegeville Road, Bldg 4, 4^th FL
		Collegeville, PA., 19426 (marc.2.harris@gsk.com)

	If to LIXTE:	LIXTE Biotechnology Holdings, Inc
		Attn: Eric J. Forman (eforman@lixte.com)
		680 E Colorado Blvd., Suite 180
		Pasadena, CA 91101

		With a copy to:
		Cooley LLP
		Attn: Matthew E. Langer (mlanger@cooley.com)
		55 Hudson Yards
		New York, NY 10001-2157

	If to Institution:
		The University of Texas M.D. Anderson Cancer Center
		7007 Bertner Avenue, 1MC11.3343
		Legal Services, Unit 1674
		Attn: Chief Legal Officer
		Houston, TX 77030
		Phone: (713) 745-6633; Facsimile: (713) 745-6029

		With a copy to:
		The University of Texas M.D. Anderson Cancer Center
		7007 Bertner Ave.
		Office of Sponsored Programs, Unit 1676
		Attn: Associate VP, Research Administration
		Houston, TX 77030
		Phone: (713) 792-3220; Facsimile: (713) 794-4595

		Investigator:
		Vice Chair for Clinical Research
		Director of the Gynecologic Cancer Immunotherapy Program
		Professor, Department of Gynecologic Oncology and Reproductive Medicine
		The University of Texas MD Anderson Cancer Center.
		1515 Holcombe Blvd., Unit 1362
		Houston, TX 77030
		Attn: Dr. Amir Jazaeri (aajazaeri@mdanderson.org)

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18.7

Entire Agreement; No Modification. This Agreement, including all Appendices which are incorporated into this Agreement, constitutes the entire agreement among the Parties with respect to the Study that is the specific subject matter of this Agreement and supersedes all prior agreements, oral or written, with respect to such subject matter. This Agreement may not be amended or modified except in a written instrument signed by an authorized representative of each of Institution, GSK and LIXTE, and acknowledged by Investigator. Any conflicts between any Appendices and this Agreement will be governed and controlled by provisions of the main text of this Agreement.

18.8

Severability; Reformation. Each provision in this Agreement is independent and severable from the others, and no provision will be rendered unenforceable because any other provision is found by a proper authority to be invalid or unenforceable in whole or in part. If any provision of this Agreement is found by such an authority to be invalid or unenforceable in whole or in part, such provision will be changed and interpreted so as to best accomplish the objectives of such unenforceable or invalid provision and the intent of the Parties, within the limits of applicable law.

18.9

Governing Law. Institution is an agency of the State of Texas and under the Constitution and the laws of the State of Texas possesses certain rights and privileges, is subject to certain limitations and restrictions, and only has such authority as is granted to it under the Constitution and laws of the State of Texas. This Agreement and any disputes arising out of or relating to this Agreement will be governed by, construed and interpreted in accordance with the Constitution and laws of the State of Texas, without regard to any choice of law principle that would require the application of the law of another jurisdiction.

18.10

Waivers. Any delay in enforcing a Party’s rights under this Agreement, or any waiver as to a particular default or other matter, will not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement, except with respect to an express written waiver relating to a particular matter for a particular period of time signed by an authorized representative of the waiving Party, as applicable. To clarify, any such waiver by GSK, LIXTE, or Institution must be evidenced by an instrument in writing executed by an officer of such party authorized to execute waivers.

18.11

Rights Cumulative. The rights and remedies contained in this Agreement are cumulative and not exclusive of any rights or remedies provided by law.

18.12

Party Rights. Except as specifically provided in this Agreement, nothing expressed or implied herein is intended, or will be construed, to confer upon or give any person other than the Parties hereto, and their successors or permitted assigns, any right, remedy, obligation or liability under or by reason of this Agreement, or result in such person being deemed a third-party beneficiary of this Agreement.

18.13

No Strict Construction; Headings; Interpretation. This Agreement has been prepared jointly and will not be strictly construed against any Party. This Agreement contains headings only for convenience and the headings do not constitute or form a part of this Agreement, and should not be used in the construction of this Agreement. The words “include,” “includes” and “including” when used in this Agreement are deemed to be followed by the phrase “but not limited to.”

18.14

Counterparts. This Agreement may be executed in any number of counterparts, each of which will be deemed to be an original and all of which together will constitute one and the same instrument. An executed counterpart of this Agreement (the entire Agreement, not just a signature page) may be delivered by e-mail (in PDF or another agreed format).

18.15

Force Majeure. No Party shall be liable to any other for any delay or non-performance of its obligations under this Agreement arising from any Force Majeure Event. “Force Majeure Event” means any act or event, in whole or in part, whether foreseen or unforeseen, that is beyond the reasonable control of a Party, but excludes economic hardship or insufficiency of funds.

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18.16

Academic Freedom. Subject to the obligations herein, nothing in this Agreement will limit or prohibit Institution or any of its personnel, including the Investigator, from conducting any research or from performing research for or with any entity or person, including any other outside sponsors. GSK and LIXTE acknowledges that this provision is intended to preserve the academic freedom and integrity of Institution and its faculty and to ensure that Institution and its faculty are not regarded as exclusive researchers for GSK or LIXTE.

18.17

Subordination to Applicable Law. The Parties will not be required to perform any act or to refrain from any act that would violate any law. This Agreement is subject to, and the Parties agree to comply with, all applicable laws. Any provision of any law, statute, rule or regulation that invalidates any provision of this Agreement, that is inconsistent with any provision of this Agreement, or that would cause one or any of the Parties hereto to be in violation of law will be deemed to have superseded the terms of this Agreement. The Parties, however, will use all reasonable endeavors to accommodate the terms and intent of this Agreement to the greatest extent possible consistent with the requirements of the law and will negotiate in good faith toward amendment of this Agreement in such respect. If the Parties cannot reach agreement on an appropriate amendment, then this Agreement may be immediately terminated by either Party.

18.18

Notice of Texas State Agency. Institution is an agency of the State of Texas and under the Constitution and the laws of the State of Texas possesses certain rights and privileges, is subject to certain limitations and restrictions, and only has such authority as is granted to it under the Constitution and laws of the State of Texas. Notwithstanding any provision hereof, nothing in this Agreement is intended to be, nor will it be construed to be, a waiver of the sovereign immunity of the State of Texas or a prospective waiver or restriction of any of the rights, remedies, claims, and privileges of the State of Texas. Moreover, notwithstanding the generality or specificity of any provision hereof, the provisions of this Agreement as they pertain to Institution are enforceable only to the extent authorized by the Constitution and laws of the State of Texas; accordingly, to the extent any provision hereof conflicts with the Constitution or laws of the State of Texas or exceeds the right, power or authority of Institution to agree to such provision, then that provision will not be enforceable against Institution or the State of Texas.

[Signaturepage to follow]

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INWITNESS WHEREOF, this Agreement is executed as of the Effective Date by a duly authorized representative of each of GSK, LIXTE andInstitution.

GLAXOSMITHKLINE LLC		Lixte Biotechnology Holdings. Inc.

By:	/s/ Marc Harris	By:	/s/ John S. Kovach
Print Name:	Marc Harris	Print Name:	John S. Kovach, MD
Title:	Assoc Director	Title:	CEO
Date:	18-Sep-2023	Date:	Sep 18, 2023

The University of Texas M. D. Anderson Cancer Center

By:	/s/ Amy M Moritz
Print Name:	Amy M Moritz
Title:	Assistant Director, ORA
Date:	8/28/2023

Read and Acknowledged:

INVESTIGATOR

	/s/ Amir Jazaeri
Print Name:	Amir Jazaeri, MD
	8/28/2023

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AppendixA

DELINEATIONOF GSK AND lixte INVESTIGATIONAL PRODUCT (“IP”) RESPONSIBILITIES

Institution Contact for IP

Investigational Pharmacy Services INVdrugs@mdanderson.org

GSK Contact for IP

Tyler Lockard , Study Delivery Lead external.research@gsk.com

LIXTE Contact for IP

Eric Forman eforman@lixte.com

GSK IP LIXTE IP		Investigational Dostarlimab (50mg/mL (10mLvial)) Investigational LB-100 (1 mg/mL (10mL vial)
Number of Study Subjects		Twenty-one (21) (includes Northwestern Study Subjects)
Average Number of Cycles/Subject		14
Participating Country		US
Number of Participating Sites		2 (two)
Study Type		☒ Open: Identity of the Investigational Product is not withheld from the investigator or subjects at the time of dispensing ☐ Blind: The investigator, pharmacist, and subjects are not able to distinguish between treatment groups at time of dispensing* ☐ Third-party Blind: The investigator and subjects are not able to distinguish between treatment groups, but pharmacy staff will have access to the identity of the IP at the time of dispensing

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Study Set Up	Institution	GSK or qualified delegate for GSK IP Only	LIXTE or qualified delegate for LIXTE IP Only
Description of IP provided to country regulatory authorities, and provision of cross-reference letter for use by Institution		X	X
Submission to regulatory authority, as appropriate (Clinical Trial Application or IND.	X
Supply of IP with appropriate labeling		X	X
Additional labeling to comply with applicable local, legal and regulatory requirements, if necessary	X
Retention samples of IP		X	X

IP Set Up

Institution

GSK or qualified delegate for GSK IP Only

LIXTE or qualified delegate for LIXTE IP Only

Collection of regulatory approvals and submission of Institution’s and Participating Site’s initial shipment approval checklist to GSK and LIXTE

Shipment Strategy		Institution		GSK or qualified delegate for GSK IP Only		LIXTE or qualified delegate for LIXTE IP Only
Shipment direct to Institution and Participating Site(s)				X		X

IP Management	Institution	GSK or qualified delegate for GSK IP Only	LIXTE or qualified delegate for LIXTE IP Only
Provide Institution /Investigator with expiry date, storage conditions, and allowable excursions in a storage and handling manual		X	X
Provide GSK & LIXTE with acknowledgement of receipt of all IP shipments to Participating Site(s)	X
Monitor expiry date, comply with storage conditions, and report temperature excursions	X
Assessment of potential quality issues which occur during shipment or storage of IP to Participating Site(s)		X	X
Report inventory use and resupply IP requirements as specified by GSK or LIXTE, including real time use of IRT/RTSM system, as applicable.	X
Decision to recall		X	X
Execution of recall(s), if applicable, including communication of recall to Participating Site(s)	X
Providing recall communication and reporting compliance of recall to GSK and LIXTE	X
Destruction of IP (at end of study or recall) and written memo confirming destruction of IP at Participating Site(s)	X

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SCHEDULE1 TO APPENDIX A

SUPPLIESAGREEMENT FORM

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APPENDIXB: FUNDING

Institution:		The University of Texas MD Anderson Cancer Center
Investigator:		Dr. Amir A.Jazaeri
GSK Investigational Product:		Dostarlimab
GSK Protocol # :		219582

1.	Enrollment of Study Subjects

Institutionwill enroll (which, for clarity, does not include any screening failures) a maximum of twenty-one (21) Study subjects (includes StudySubjects at Northwestern) on the Protocol and use reasonable efforts to achieve an expected rate of 2 Study subjects/month. GSK willpay Institution for Study subjects enrolled on the Protocol that receive at least one dose of GSK Investigational Product and LIXTE InvestigationalProduct, in accordance with the schedule below.

2.	Payment Schedule

GSKagrees to provide Funding in support of the conduct of the Study in the total amount of $1, 493,019.40 USD. Funding will be providedas follows:

Milestone	$ Payment USD
Upon receipt by GSK of (i) the final and fully executed Agreement, (ii) all required documentation, and, (iii) confirmation that the summary Protocol has been posted on clinicaltrials.gov or other public register in accordance with the Agreement.		160,345.04
Upon enrollment of 1 (one) Study subject.		172,345.08
Upon enrollment of 4 additional (four) Study subjects (total 5).		172,345.08
Upon enrollment of 4 additional (four) Study Subjects (total 9).		172,345.08
Upon enrollment of 4 additional (four Study Subjects (total 13).		172,345.08
Upon enrollment of 4 additional (four) Study Subjects (total 17).		172,345.08
Upon enrollment of 4 additional (four) Study Subjects (total 21).		172,345.08
Upon receipt of documentation that (i) 21 Study Subjects have completed the Study; (ii) GSK’s receipt of the Final Report or draft manuscript in accordance the Communication of Data Section of this Agreement; (iii) confirmation that final Results summary has been posted to www.ClinicalTrials.gov or other public register in accordance with the Publication Section of this Agreement; and (iv) documentation of attempt of publication. If the Investigator and GSK agree that the Study Results do not support a publication, a written final study report may be accepted for final payment.		298,603.88
TOTAL		1,493,019.40

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3.	Invoicing

Toensure timely payment, all invoices will be submitted to Tyler Lockard (external.research@gsk.com) (“SAP”) in accordancewith the invoice instructions below. GSK will pay Institution within thirty (30) days from GSK receipt of invoice. Institution shallcreate and submit all its invoices and/or credit notes and sent through email to the SAP. Each Invoice will have to indicate the PurchaseOrder number, that will be communicated by GSK after contract execution, as well as the following information:

	i.	Invoice addressed to: GSK LLC, 1250 South Collegeville Road, Collegeville, PA., 19426
	ii.	Institution Name/address:
	iii.	Study Title: 219582
	iv.	CID: 574189
	v.	Invoice number & date:
	vi.	Purchase Order Number:
	vii.	GSK Contact: Tyler Lockard
	viii.	VAT ID number
	ix.	Detailed description of services/milestone:
	x.	Bank account name/address & Sort Code

Failureto provide the required information will delay approval and the invoice may be returned for revisions.

PaymentInstructions:

Paymentsshall be made by Electronic Funds Transfer via the Automated Clearing House (ACH), which is Institution’s preferred method to receivepayments.

FORACH DELIVERY

BankRouting Number: 111000614; Account Number: 522292058

AccountName: Univ. of Texas MD Anderson Cancer Center-Office of Grants and Contracts

4.	Reconciliation

Inthe event that the Study closes enrollment prior to achievement of the maximum number of Study subjects, Institution shall provide writtennotice to GSK of the date the Study was closed, the proposed funding reconciliation, the number of Study subjects that are eligible forpayment in accordance with the terms in Section 1, and any other relevant documentation supporting the plan. GSK will review the proposedreconciliation and will respond with any objections.

ThePayment Schedule described in Section 2 will be prorated up to a maximum of:

Description	Per Unit Cost (USD)		# Units		$ Total USD
One-time start-up fees						160,345.04
Per Study subject costs		63,460.67		21		1,332,674.06
Total						1,493,019.10

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AppendixC: TASK RESPONSIBILITY MATRIX

TASK	GSK	LIXTE	Institution
Budget
Make payments according to milestones agreed in contract	X
Develop itemised budget			X
Study Start Up
Site/Investigator selection & training			X
Scientific exchange on research proposal	X	X	X
Create study documents (Protocol, ICF, Statistical Plan, CRF, Diary Cards, and Laboratory Manual etc.)			X
Contribute to study documents (review and comment) NB type of study documents to be detailed Study Protocol, ICF(s), Pharmacy Manual, GSK /LIXTE Investigational Product Handling Instructions, Laboratory Manual GSK /LIXTE also to contribute for comments received by CA / EC as required and especially in relation to the GSK Investigational Product and LIXTE Investigational Product	X	X	X
Service Provider selection and contract, including laboratories if applicable			X
Regulatory (e.g. IND application or amendment)			X
Ethics Committee/Institutional Review Board Submission			X
Protocol Summary posting on ClinicalTrials.gov			X
Study Conduct
GSK and LIXTE to provide respective IP to Participating Site (s), upon Institution providing shipping details (address and name) to GSK and LIXTE	X	X
Conduct study in adherence with applicable GxP and regulatory requirements			X
Study site management (e.g., Monitoring visit, Investigator site file, etc.)			X
Ensure sites use GSK’s IRT system in real-time to enroll patients, dispense drug and manage drug study			X
Perform Quality Assurance site audits			X
Updates to the Investigator’s Brochure for respective IP	X	X
Data collection and data management			X
Human Biological Sample Management			X
Storage of samples as per Study Protocol for future research and development			X
Report Clinical Safety Information (SAE & pregnancy initial and follow-up) to GSK and LIXTE			X
Transfer of samples to GSK and/or LIXTE or preferred vendor for future research and development if required			x
Submit safety report to ECs/IRBs/regulatory authorities			X
Provide on a quarterly basis a line listing of all SAE and pregnancies received during a defined quarter to GSK. These listings should be sent to the following email address: PV.ICSRManagement@gsk.com			X
Perform reconciliation and feedback to Institution on quarterly basis upon line listing receipt	X	X
Perform audit activities of Institution activities	X	X
STUDY CLOSURE & ARCHIVING
Conduct Participating Site Close out activities including product reconciliation			X
Perform Data Management and Statistical Analysis			X
Provide Data to GSK and to LIXTE			X
Create Study Report and Manuscript			X
Review Study Report and Manuscript	X	x
Contribute (review and comment) to publications (abstracts, presentations, CSR, Manuscripts)	X	x
Disclosure of Study Results Summary and submission of manuscripts			x
Notification of Study end to regulatory authorities and ECs/IRBs			x
Archiving of study files			x

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APPENDIXD

Safetyand Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma (OCCC) using Dostarlimab and LB-100

PROTOCOLPROVIDED SEPARATELY AND REFERRED TO IN THIS AGREEMENT AS IF SET FORTH IN FULL

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APPENDIXE

ANTICIPATEDTIMELINES

Milestone		Target Date (dd/mon/year)
Final Protocol approved		07/JUN/2023
Ethics Committee(EC) / Competent Authority (CA) submission		21/JUN/2023
EC /CA approval		01/AUG/2023
First Subject, First Visit		01/OCT/2023
Last Subject, First Visit		01/AUG/2025
Last Subject, Last Visit		01/AUG/2026
Database Freeze		01/AUG/2027
Final Report (or draft manuscript) delivered to GSK in accordance with Clause 4.1		01/JAN/2028
Manuscript in accordance with Clause 4.1 submitted for publication within 90 days of Study completion at all Study Site(s)		01/APR/2028

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APPENDIXF:

SafetyLanguage for Supported Studies GSK InvestigationalProduct

Institution/InvestigatorObligations

UnderGCPs, applicable laws, and terms of this Agreement, Institution is responsible for and undertakes to assess all clinical safety informationarising during the Study in order to generate all safety reports as required by applicable laws. Such safety reports will include, butmay not be limited to, Individual Case Safety Reports (“ICSRs”) for Suspected Unexpected Serious Adverse Reactions (“SUSARs”)and, where applicable, Development Safety Update Report(s) (“DSURs”). Institution is responsible for submitting such reportsto all concerned regulatory authorities, relevant Independent Ethics Committee(s) (“IEC”) or Institutional Review Board IRB(s)and individual Study investigator(s), as required, and within applicable timelines.

Inthe event that GSK maintains its own IB(s) for the GSK IMP being investigated under the Study, regardless of the indication under study,GSK will provide these IB(s), and any updates, and/or supplements to these IB(s) to Institution during the course of the Study for informationpurposes. Institution shall communicate the IB to the Investigator and Sub-investigators during the course of the Study for informationpurposes.

Ifany GSK IMP being investigated under the Study are marketed products, or become marketed products during the Study, Institution shallbe responsible for providing to the Investigator, Participating Site(s), and Sub-investigator(s) access the current approved local countryproduct information in respect of the marketed GSK IMP through whatever means available to health care professionals in the countrieswhere the Study will be conducted (e.g., internet repositories, published compendia/formularies, etc.).

Inthe event that GSK produces any of its own DSURs in respect of the GSK IMP, GSK will provide to Institution on request and for the durationof the Study, copies of the executive summary and any line listings of serious adverse reactions extracted from approved GSK DSURs forinformation only and to assist Institution in the generation of its own DSUR(s), where applicable. Investigator and Institution agreesnot to forward such GSK DSUR sections to any third party.

GSKwill ensure that any urgent safety issues relating to the GSK IMP provided for the Study will be communicated to the Institution by whatevermeans that GSK, in its sole discretion, deems appropriate. The Institution shall communicate such issues to the Investigator, ParticipatingSite(s), and Sub-investigator(s) during the course of the Study.

Forms

Institutionwill use its internal form for SAE reporting and GSKs forms for pregnancy reporting.

CaseExchange

Investigator shall report all SAEs arising during the Study in Study Subjects exposed to the GSK IMP (as defined by the Protocol), to GSK (as specified below) using an approved form within twenty-four (24) hours or latest one (1) business day of first becoming aware of the event, regardless of Investigator/designee causality assessments against GSK IMP.

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PregnancyInformation

Investigator will report pregnancy information on any female Study Subject who becomes pregnant while participating in the Study and following exposure to a GSK IMP, to GSK (as specified below) using an approved form within 24 hours or latest one (1) business day of first becoming aware of the pregnancy. The Study Subject will also be followed to determine the outcome of the pregnancy (including any premature termination of the pregnancy). Information on the status of the mother and child will be forwarded to GSK. Generally, follow-up will be requested by GSK no longer than six (6) to eight (8) weeks following the estimated delivery date.

Note:There are two forms – initial and follow-up.

ReportingClinical Safety Information to GSK

In this Study, there is the potential for the unsolicited reporting of GSK-product-related events, by a patient, to the Investigator, and/or there is the potential that the Investigator may read of GSK-product-related events in a patient’s medical records. Any events (AE, SAE, or pregnancies) considered to be related to a GSK product, that occur during the Study, need to be reported according to country regulatory guidelines. Study participation-related events should be collected and reported according to country regulatory guidelines.

ReportingPeriod

d.	The SAEs and pregnancy reports that are subject to the above reporting provisions are those that occur following the first dose of the GSK IMP as long as Protocol defines.

RequestingFollow-up Information

e.	Investigator will provide GSK with details of whom GSK shall address requests for follow up information on SAE and pregnancy reported from this Study, and further agrees to update such contact details as necessary. At the time of this Agreement, all such requests should be addressed to:

Dr.Amir Jazaeri (aajazaeri@mdanderson.org)

Investigatorshall submit to GSK (as specified above) such further detailed information relating thereto as GSK shall request within twenty-four (24)hours or latest one (1) business day of it becoming available.

EventsExempt from Reporting to GSK

f.	Any blinded ICSRs or any unblinded reports for Study Subjects exposed only to placebo or a non-GSK comparator during the Study.

Routingof Clinical Safety Data to GSK

Notwithstanding the Force Majeure Clause of this Agreement, such reports and information as outlined above, including Investigator causality assessments against all concerned GSK IMP and English translations where reporting is from a non-English speaking country, shall be sent via email to the below destination:

Pharma:OAX37649@GSK.com

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Reconciliations

IfSCS: Quarterly reconciliations shall be performed.

Communicationfor reconciliation shall be sent via email to the below destination:

Reconciliationmailbox: Pharma: PV.ICSRManagement@gsk.com

Definitions

AdverseEvent (AE) – Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and whichdoes not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintendedsign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether ornot considered related to the medicinal product.

AdverseEvents of Special Interest (AESI) - An adverse event of special interest (serious or non-serious) is one of scientific and medicalconcern specific to the Institution’s product or program, for which ongoing monitoring and rapid communication by the investigatorto the Institution can be appropriate. Such an event might warrant further investigation in order to characterize and understand it.Depending on the nature of the event, rapid communication by the trial Institution to other parties (e.g., regulators) might also bewarranted.

DevelopmentSafety Update Report (DSUR) – A periodic reporting on drugs under development (see ICH-E2F Guideline, Volume 10 of the RulesGoverning Medicinal Products in the EU).

EmergingSafety Issue - A safety issue considered by a marketing authorisation holder to require urgent attention by the competent authoritybecause of the potential major impact on the risk-benefit balance of the medicinal product and/or on patients’ or public healthand the potential need for prompt regulatory action and communication to patients and healthcare professionals. Examples include: majorsafety issues identified in the context of ongoing or newly completed studies, e.g., an unexpectedly increased rate of fatal or life-threateningadverse events; major safety issues identified through the spontaneous reporting system or publications in the scientific literature,which may lead to considering a contraindication, a restriction of use of a medicinal product or its withdrawal from the market; majorsafety-related regulatory actions outside the EU, e.g., a restriction of use of a medicinal product or its suspension.

InvestigationalNew Drug Safety Report (INDSR) - Is a written safety report used by Institutions to notify FDA of any adverse experience associatedwith the use of the drug that is both serious and unexpected.

Investigator’sBrochure (IB) - A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the studyof the investigational product(s) in human subjects.

PregnancyCases - Cases originating from spontaneous or clinical trial sources. Pregnancy data is any abnormal pregnancy, normal pregnancyoutcome or adverse event/special situation following direct exposure to a GSK product, via a patient’s partner, or via breast milk(lactation exposure).

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Pregnancy/LactationExposure - With or without any AEs related to the parent or child. Use of a product while pregnant and/or breastfeeding.

ReferenceSafety Information (RSI) - In periodic benefit-risk evaluation reports for medicinal products, all relevant safety information containedin the reference product information (e.g., the company core data sheet) prepared by the marketing authorisation holder and which themarketing authorisation holder requires to be listed in all countries where it markets the product, except when the local regulatoryauthority specifically requires a modification (see GVP Annex IV, ICH-E2C(R2) Guideline)”

SeriousAdverse Event (SAE) - An untoward medical occurrence that at any dose: results in death, is life-threatening (NOTE: The term “life-threatening”in the definition of “serious” refers to an event in which the patient was at risk of death at the time of the event; itdoes not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalisation orprolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect,is a medically important event or reaction

Signal- Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causalassociation, or a new aspect of a known association between an intervention and an event or set of related events, either adverse orbeneficial, that is judged to be of sufficient likelihood to justify verificatory action.

SuspectedUnexpected Serious Adverse Reaction (SUSAR) - All suspected adverse reactions related to an IMP (the tested IMP and comparators)which occur in the concerned trial that are both unexpected and serious (SUSARs) are subject to expedited reporting.

Termsof Interest (TOI) - A group of MedDRA terms maintained in the Integrated Coding Dictionary System (ICDS). TOIs may be comprised oflevels of the MedDRA hierarchy at the Preferred Term (PT) level or higher. TOIs may also be constructed from Standardized MedDRA Queries(SMQs), other TOIs in a ‘building-block’ manner or contain mixtures of TOIs and levels of the MedDRA hierarchy.

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APPENDIXG

InstitutionInvestigational Pharmacy Services (IPS) Requirements

1.	Minimum Labeling Standards

ProductLabeling by GSK and LIXTE

GSK and LIXTE shall ensure that all immediate containers of their respective Investigational Product must, at a minimum, be labeled with the following information:

	i.	Name of product
	ii.	Lot or batch number
	iii.	Storage conditions
	iv.	Quantity
	v.	Formulation
	vi.	Name and address of manufacturer or GSK or LIXTE, as applicable

Note:Investigational Product that is shipped to Institution and not labeled as described above will be deemed unacceptable for use andwill be destroyed or returned to GSK or LIXTE, as applicable, at its cost.

2.	Drug Expiration/Re-Test Dating Information

GSKand LIXTE shall ensure that Re-test and/or expiration dating information shall be provided to Institution with each lot of their respectiveInvestigational Product. Investigational Product may be quarantined by Institution until such information is provided.

Page 38 of 38 Confidential

Exhibit31.1

CERTIFICATIONOF CHIEF EXECUTIVE OFFICER

UNDERSECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I,Geordan Pursglove, certify that:

1.	I have reviewed this Quarterly Report on Form 10-Q of Lixte Biotechnology Holdings, Inc.;

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.	I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)), for the registrant and have:

	(a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to me by others within those entities, particularly during the period in which this report is being prepared;

	(b)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

	(c)	Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

	(d)	Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.	I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s Board of Directors (or persons performing the equivalent functions):

	(a)	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

	(b)	Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 7, 2025	By:	/s/ GEORDAN PURSGLOVE
		Geordan Pursglove
		Chief Executive Officer
		(Principal Executive Officer)

Exhibit31.2

CERTIFICATIONOF CHIEF FINANCIAL OFFICER

UNDERSECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I,Robert N. Weingarten, certify that:

1.	I have reviewed this Quarterly Report on Form 10-Q of Lixte Biotechnology Holdings, Inc.;

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.	I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)), for the registrant and have:

	(a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to me by others within those entities, particularly during the period in which this report is being prepared;

	(b)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

	(c)	Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

	(d)	Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.	I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s Board of Directors (or persons performing the equivalent functions):

	(a)	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

	(b)	Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 7, 2025	By:	/s/ ROBERT N. WEINGARTEN
		Robert N. Weingarten
		Vice President and Chief Financial Officer

Exhibit32.1

CERTIFICATIONSOF CHIEF EXECUTIVE OFFICER

UNDERSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

I,Geordan Pursglove, the Chief Executive Officer of Lixte Biotechnology Holdings, Inc. (the “Company”), certify, pursuant toSection 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350, that:

(i)The Quarterly Report on Form 10-Q of the Company for the quarterly period ended June 30, 2025 (the “Report”) fully complieswith the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and

(ii)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operationsof the Company.

Asigned original of this written statement required by Section 906 has been provided to the Company and will be retained by the Companyand furnished to the Securities and Exchange Commission or its staff upon request.

Date: August 7, 2025	By:	/s/ GEORDAN PURSGLOVE
		Geordan Pursglove
		Chief Executive Officer
		(Principal Executive Officer)

Exhibit32.2

CERTIFICATIONSOF CHIEF FINANCIAL OFFICER

UNDERSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

I,Robert N. Weingarten, the Chief Financial Officer of Lixte Biotechnology Holdings, Inc. (the “Company”), certify, pursuantto Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350, that:

(ii)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operationsof the Company.

Date: August 7, 2025	By:	/s/ ROBERT N. WEINGARTEN
		Robert N. Weingarten
		Vice President and Chief Financial Officer
		(Principal Financial and Accounting Officer)