UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
Report of Foreign Private Issuer Pursuant to Rule 13a-16or 15d-16
Under the Securities Exchange Act of 1934
For the Month of August
Commission File Number:
NeuroSense Therapeutics Ltd.
(Translation of registrant’s name into English)
11 HaMenofim Street, Building B
Herzliya 4672562 Israel
+972-9- 7996183
(Address of principal executive offices)
Indicate by check mark whether the registrant filesor will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Explanatory Note
Attached are theCompany’s press release providing a business update for the first half of 2025, condensed interim unaudited financialstatements and a summary of its operating and financial review and prospects, each as of June 30, 2025, furnished herewith asExhibits 99.1, 99.2 and 99.3, respectively.
This Report on Form6-K (including the three bullet points following “Upcoming Corporate Highlights for H2 2025 include:” in Exhibit 99.1and Exhibits 99.2 and 99.3) is hereby incorporated by reference into the registrant’s Registration Statements on Form S-8 (File No. 333-262480) and Form F-3 (File No. 333-269306, 333-260338, 333-283656 and 333-284051),to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reportssubsequently filed or furnished.
1
Exhibit Index
| Exhibit No. | Description | |
| 99.1 | Press Release dated August 1, 2025 | |
| 99.2 | Condensed Interim Unaudited Financial Statements as of June 30, 2025 | |
| 99.3 | Operating and Financial Review and Prospects as of June 30, 2025 | |
| 101.INS | Inline XBRL Instance Document | |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document | |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
| 101.DEF | Inline XBRL Taxonomy Extension Label Linkbase Document | |
| 101.LAB | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
| 101.PRE | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
| 104 | Cover Page Interactive Data File formatted as Inline XBRL and contained in Exhibit 101 |
2
SIGNATURES
Pursuant to the requirementsof the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereuntoduly authorized.
| NeuroSense Therapeutics Ltd. | ||
| Date: August 1, 2025 | By: | /s/ Alon Ben-Noon |
| Alon Ben-Noon | ||
| Chief Executive Officer | ||
3
Exhibit 99.1
NeuroSense Provides Business Updateand Progress for the First Half of 2025
CAMBRIDGE, Mass., August 1, 2025 /PRNewswire/ -- NeuroSenseTherapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company developing novel treatmentsfor severe neurodegenerative diseases, today provided business update with corporate highlights to date and financial results ofthe first half of 2025.
NeuroSense is advancing PrimeC, its investigational combinationtherapy for amyotrophic lateral sclerosis (ALS), through regulatory pathways while preparing for a pivotal Phase 3 trial.
“The first half of 2025 has been transformational forNeuroSense. We regained compliance with Nasdaq’s stockholders’ equity requirement, generated additional long–term data from ourPhase 2b ALS, PARADIGM study, and advanced our manufacturing capabilities,” said Alon Ben–Noon, Chief Executive Officerof NeuroSense. “Our team is focused on accelerating the path to a pivotal Phase 3 trial as the next step in potentially bringinga meaningful treatment to people living with ALS as quickly as possible.”
Upcoming Corporate Highlights for H2 2025 include:
| ● | NOC/cSubmission in Canada – Following feedback from Health Canada that the Company’s initial request did not fulfill the criteriafor advanced consideration under the Notice of Compliance with conditions (NOC/c) policy, and in line with Health Canada’s suggestion,NeuroSense plans to submit a new request supported by additional data, with the goal of securing an NOC/c for PrimeC. |
| ● | Phase 3trial commencement – Following positive regulatory feedback from the FDA, NeuroSense plans to begin a multinational Phase 3study of PrimeC in ALS in the second half of 2025. |
| ● | Advancingbinding term sheet with a global pharmaceutical partner – Following the execution of a binding term sheet in the fourth quarterof 2024 to advance the development and commercialization of PrimeC, its proprietary treatment drug for ALS in certain key territories,discussions are continuing and may yield a definitive partnership agreement in the near future. |
First Half 2025 Corporate Highlights
| ● | Nasdaqlisting compliance restored In January 2025 NeuroSense received formal notice from Nasdaq that it had regained compliance with the stockholders’ equityrequirement after completing a $5 million private placement in December 2024. The financing strengthened the Company’sbalance sheet and raised shareholders’ equity above Nasdaq’s minimum requirement. |
| ● | Additionallong–term data from the Phase 2b PARADIGM study In February 2025 NeuroSense reported new analyses from the completed 18–month Phase 2b PARADIGM study in ALS. Thenew analysis revealed that in the per-protocol population (participants who adhered to the protocol), treatment with PrimeC slowed functionaldecline by ~40%. Overall survival improved by 74%, complication–free survival improved by 79%, and patients experienced slowerdecline in slow vital capacity by 26%. These data reinforce the disease–modifying potential of PrimeC and underpin the design ofthe planned Phase 3 study. |
| ● | Presentationof biomarker and mechanistic data At the Annual Meeting of the American Academy of Neurology (AAN) in April 2025, members of NeuroSense’s scientific advisoryboard presented further analyses from the PARADIGM study. Dr. Jeremy Shefner highlighted safety, efficacy and biomarker datashowing that PrimeC has disease–modifying potential and may redefine ALS treatment. Dr. Jeffrey Rosenfeld discussed microRNAmodulation and iron–related biomarkers as evidence of multi–target engagement. These findings were later expanded upon ina release describing how PrimeC consistently modulated microRNAs associated with ALS, providing mechanistic insight consistent with observedclinical improvements. |
| ● | Manufacturingscale–up to commercial levels In May 2025 NeuroSense successfully scaled production of PrimeC to a commercial level and selected a global contract developmentand manufacturing organization (CDMO) to ensure supply chain readiness for potential commercialization. The Company validated the manufacturingprocess, qualified suppliers, and demonstrated product stability supporting a 36–month shelf–life. |
H1 2025 Financial Results:
| ● | Researchand development expenses for the six months ended June 30, 2025 and 2024 were $2,503 thousand and $3,733 thousand, respectively.The decrease of $1,230 thousand, or 32.9%, was mainly attributed to the decrease in clinical activity. |
| ● | Generaland administrative expenses for the six months ended June 30, 2025 and 2024 were $2,189 thousand and $2,291 thousand, respectively.The decrease of $102 thousand, or 4.4%, is considered immaterial. |
| ● | Operatingexpenses for the six months ended June 30, 2025 and 2024 were $4.7 million and $6 million, respectively dueto the reasons described above. |
2
A summary of NeuroSense’s unaudited consolidated financial resultsis included in the tables below.
NeuroSense Therapeutics Ltd.
Condensed Interim Unaudited balance sheets
U.S. dollars in thousands
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalent | 666 | 3,378 | ||||||
| Other receivables | 847 | 989 | ||||||
| Restricted deposit | 43 | 35 | ||||||
| Total current assets | 1,556 | 4,402 | ||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | 63 | 66 | ||||||
| Operating right of use assets | 42 | 84 | ||||||
| Restricted deposit | 23 | 23 | ||||||
| Total non-current assets | 128 | 173 | ||||||
| Total assets | 1,684 | 4,575 | ||||||
| Liabilities and Equity | ||||||||
| Current liabilities: | ||||||||
| Trade payables | 1,093 | 1,160 | ||||||
| Other payables | 1,110 | 832 | ||||||
| Total current liabilities | 2,203 | 1,992 | ||||||
| Total liabilities | 2,203 | 1,992 | ||||||
| Shareholders’ equity: | ||||||||
| Authorized: 90,000,000 shares at March 31, 2025 and December 31, 2024; Issued and outstanding: 24,602,405 and 23,228,941 shares at June 30, 2025 and December 31, 2024, respectively | - | - | ||||||
| Share premium and capital reserve | 40,850 | 39,243 | ||||||
| Accumulated deficit | (41,369 | ) | (36,660 | ) | ||||
| Total Shareholders’ equity (deficit) | (519 | ) | 2,583 | |||||
| Total liabilities and shareholders’ equity (deficit) | 1,684 | 4,575 | ||||||
3
NeuroSense Therapeutics Ltd.
Condensed Interim Unaudited Statements of Comprehensive Loss
U.S. dollars in thousands except share and per share data
| Six months ended June 30, 2025 | Six months ended June 30, 2024 | |||||||
| Research and development expenses | (2,503 | )(*) | (3,733 | ) | ||||
| General and administrative expenses | (2,189 | )(*) | (2,291 | ) | ||||
| Operating loss | (4,692 | ) | (6,024 | ) | ||||
| Financing expenses, net | (17 | ) | (237 | ) | ||||
| Net loss and comprehensive loss | (4,709 | ) | (6,261 | ) | ||||
| Basic and diluted net loss per share | (0.19 | ) | (0.37 | ) | ||||
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 25,402,649 | 16,773,806 | ||||||
| (*) | Reclassified |
4
NeuroSense Therapeutics Ltd.
Condensed Interim Unaudited Statements of Changes in Equity
U.S. dollars in thousands (except for share and per share data)
| Ordinary shares | Share premium and capital reserve | Accumulated deficit | Total equity | |||||||||||||||||
| Number | Amount | |||||||||||||||||||
| Balance as of January 1, 2025 | 23,228,941 | $ | - | $ | 39,243 | $ | (36,660 | ) | $ | 2,583 | ||||||||||
| Issuance of shares, net | 883,952 | - | 1,288 | - | 1,288 | |||||||||||||||
| Exercise of options and vested RSUs | 194,000 | 13 | 13 | |||||||||||||||||
| Share-based compensation | 295,512 | 306 | 306 | |||||||||||||||||
| Net loss and comprehensive loss | - | - | - | (4,709 | ) | (4,709 | ) | |||||||||||||
| Balance as of June 30, 2025 | 24,602,405 | $ | - | $ | 40,850 | $ | (41,369 | ) | $ | (519 | ) | |||||||||
5
About ALS
Amyotrophic lateral sclerosis (“ALS”) is an incurableneurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 peopleare diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expectedto grow by 24% by 2040 in the U.S. and EU.
About PARADIGM
PARADIGM is a prospective, multinational, randomized, double-blind,placebo-controlled Phase 2b (NCT05357950) clinical trial of PrimeC in ALS. The trial included 68 participants living with ALS in Canada,Italy, and Israel.
During the first 6 months of the trial, 45 participants wererandomized to receive PrimeC, and 23 participants were randomized to receive placebo. This was followed by a 12-month open-labelextension with all participants receiving PrimeC in a blinded manner, where neither the participants nor the clinical staff were awareof the initial treatment allocation.
Most patients enrolled in both the active and placebo arms of the trial were concurrently treated with Riluzole, the ALS standard of caremedication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA approved ALS drug.
About PrimeC
PrimeC, NeuroSense’s lead drug candidate, is a novel extended-releaseoral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designedto synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulationand impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS. NeuroSense completed a Phase2a clinical trial which met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statisticallysignificant changes in ALS-related biological markers indicating PrimeC’s biological activity. PrimeC was granted Orphan Drug Designationby the U.S. Food and Drug Administration and the European Medicines Agency.
6
About NeuroSense
NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnologycompany focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSensebelieves that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others,represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patientsto date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers,NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.
For additional information, we invite you to visit our website andfollow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on ourwebsite and these social media channels.
Forward-Looking Statements
This press release contains “forward-looking statements”that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this pressrelease are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of wordssuch as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,”“intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,”“project,” “target,” “aim,” “should,” “will” “would,” or the negative of thesewords or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are basedon NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult topredict and include statements regarding a commercial launch in Canada and market potential. Further, certain forward-looking statementsare based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actualresults could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks includethe risk that that the commercial launch of PrimeC will not expeditious, that there will not be dependable and compliant sourcing forcommercial-scale production volumes of PrimeC, that the shelf life of PrimeC will not be as anticipated, lower than anticipatedmarket opportunity in Canada and elsewhere, that regulatory approvals for PrimeC will be delayed or not obtained in Canada or elsewhere;insufficient capital to complete development of PrimeC, the timing of expected regulatory and business milestones; the potential for PrimeCto safely and effectively target ALS; preclinical and clinical data for PrimeC; the uncertainty regarding outcomes and the timing of currentand future clinical trials; the development and commercial potential of any product candidates of Neurosense; the ability of NeuroSenseto remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission(SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertaintiesaffecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securitiesand Exchange Commission on April 7, 2025 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in thisannouncement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicablelaw.
7
Exhibit 99.2
NeuroSense Therapeutics Ltd.
CondensedInterim Unaudited balance sheets
U.S. dollars in thousands
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalent | ||||||||
| Other receivables | ||||||||
| Restricted deposit | ||||||||
| Total current assets | ||||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | ||||||||
| Operating right of use assets | ||||||||
| Restricted deposit | ||||||||
| Total non-current assets | ||||||||
| Total assets | ||||||||
| Liabilities and Equity | ||||||||
| Current liabilities: | ||||||||
| Trade payables | ||||||||
| Other payables | ||||||||
| Total current liabilities | ||||||||
| Total liabilities | ||||||||
| Shareholders’ equity: | ||||||||
| Authorized: | ||||||||
| Share premium and capital reserve | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total Shareholders’ equity (deficit) | ( | ) | ||||||
| Total liabilities and shareholders’ equity (deficit) | ||||||||
Date of approval of the interim financial statements: July 30,2025
The accompanying notes are an integral part of the condensedinterim financial statements.
F-1
NeuroSense Therapeutics Ltd.
CondensedInterim Unaudited Statements of Comprehensive Loss
U.S. dollars in thousands except share and per share data
| Six months | Six months | |||||||
| ended | ended | |||||||
| June 30, | June 30, | |||||||
| 2025 | 2024 | |||||||
| Research and development expenses | ( | ) | (*) | ( | ) | |||
| General and administrative expenses | ( | ) | (*) | ( | ) | |||
| Operating loss | ( | ) | ( | ) | ||||
| Financing expenses, net | ( | ) | ( | ) | ||||
| Net loss and comprehensive loss | ( | ) | ( | ) | ||||
| Basic and diluted net loss per share | ( | ) | ( | ) | ||||
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | ||||||||
| (*) |
The accompanying notes are an integral part ofthe condensed interim financial statements.
F-2
NeuroSense Therapeutics Ltd.
CondensedInterim Unaudited Statements of Changes in Equity
U.S. dollars in thousands (except for shareand per share data)
| Ordinary shares | Share premium and capital reserve | Accumulated deficit | Total equity | |||||||||||||||||
| Number | Amount | |||||||||||||||||||
| Balance as of January 1, 2025 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Issuance of shares, net | ||||||||||||||||||||
| Exercise of options and vested RSUs | ||||||||||||||||||||
| Share-based compensation | ) | |||||||||||||||||||
| Net loss and comprehensive loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance as of June 30, 2025 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| Ordinary shares | Share premium and capital reserve | Accumulated deficit | Total equity | |||||||||||||||||
| Number | Amount | |||||||||||||||||||
| Balance as of January 1, 2024 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| Issuance of shares and pre-funded warrants, net | ||||||||||||||||||||
| Exercise of pre-funded warrants, options and vested RSUs | ||||||||||||||||||||
| Reclassification of warrants into equity (Note 3) | - | |||||||||||||||||||
| Share-based compensation | ) | |||||||||||||||||||
| Net loss and comprehensive loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance as of June 30, 2024 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
The accompanying notes are an integral part ofthe condensed interim financial statements.
F-3
NeuroSense Therapeutics Ltd.
CondensedInterim Unaudited Statements of Cash Flows
U.S. dollars in thousands
| Six months | Six months | |||||||
| ended | ended | |||||||
| June 30, | June 30, | |||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss for the period | ( | ) | ( | ) | ||||
| Adjustments: | ||||||||
| Depreciation and Amortization | ||||||||
| Share-based compensation | ||||||||
| Revaluation of liability in respect to warrants | ||||||||
| Finance expenses (income), net | ||||||||
| Changes in assets and liabilities: | ||||||||
| Decrease in operating right of use asset | ||||||||
| Decrease in operating lease liability | ( | ) | ( | ) | ||||
| Decrease (increase) in other receivables | ( | ) | ||||||
| Increase (decrease) in trade payables | ( | ) | ||||||
| Increase in other payables | ||||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities | ||||||||
| Change in restricted deposit | ( | ) | ||||||
| Purchase of property, plant and equipment | ( | ) | ( | ) | ||||
| Net cash provided by (used in) investing activities | ( | ) | ||||||
| Cash flows from financing activities | ||||||||
| Exercise of options | ||||||||
| Issuance of shares | ||||||||
| Issuance costs | ( | ) | ( | ) | ||||
| Net cash provided by financing activities | ||||||||
| Effects of exchange rate changes on cash and cash equivalents | ||||||||
| Net decrease in cash and cash equivalents | ( | ) | ( | ) | ||||
| Cash and cash equivalents at beginning of the period | ||||||||
| Cash and cash equivalents at end of the period | ||||||||
| Non-cash activity | ||||||||
| Supplemental disclosure of cash flow information: | ||||||||
| Interest received | ||||||||
The accompanying notes are an integral part ofthe condensed interim financial statements.
F-4
NeuroSense Therapeutics Ltd.
Notes tothe Condensed Interim Unaudited Financial Statements
Note 1 — General
| A. | NeuroSenseTherapeutics Ltd. (“NeuroSense” or the “Company”) was incorporated in Israel on |
In addition to PrimeC, the Companyhas initiated research and development efforts in Alzheimer’s disease and Parkinson’s disease, with a similar strategy ofcombined products.
The Company’s ordinary sharesand warrants began trading on the Nasdaq Capital Market on December 9, 2021 under the ticker symbols “NRSN” and“NRSNW,” respectively.
| B. | TheCompany currently has no products approved for sale, and the Company’s operations have been funded primarily by its shareholders.To date, the Company has generated no sales or revenues, has incurred negative networks capital and also losses and expects to incursignificant additional losses due to the continuing focus on the research, development, clinical activities of its product candidates,preclinical programs, business development, organizational structure and to advance the programs within the Company’s pipeline.Consequently, its operations are subject to all the risks inherent in the establishment of a pre-revenue business enterprise as wellas those risks associated with a company engaged in the research and development of pharmaceutical compounds. |
Based on current expected level ofoperating expenditures, the Company’s cash resources as at June 30, 2025 shall not be sufficient to fund the Company’s operationsfor a period of 12 months from the approval of these consolidated interim financial statements, assuming that the Company will continueits development plan in accordance with the original pipeline and without delaying or slowing down the progress of its plans. The Companywill require additional cash to fund the execution of its mid and long-term development program. The Company anticipates raising additionalfunds through public or private sales of debt or equity securities, collaborative arrangements, or some combination thereof. Whilst managementis progressing with its plans to secure external financing, these still require approval by third parties, and accordingly, there is noassurance that any such arrangement will be entered into or that financing will be available when needed in order to allow it to continueits operations, or if available, on terms favorable or acceptable to it.
These consolidated financial statementshave been prepared in accordance with US generally accepted accounting principles (GAAP) assuming the Company will continue as a goingconcern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business.In the event financing is not obtained, the Company may pursue cost cutting measures or may be required to delay, reduce the scope of,or eliminate any of its development programs or clinical trials, these events could have a material adverse effect on its business. Thesefactors raise significant doubt about the Company ability to continue as a going concern. The consolidated interim financialstatements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses thatmay be necessary if the Company were unable to continue as a going concern.
F-5
NeuroSense Therapeutics Ltd.
Notes tothe Condensed Interim Unaudited Financial Statements
Note 1 — General (Cont.)
| C. | In October 2023, Hamas terrorists infiltrated Israel’ssouthern border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Following the attack, Israel’ssecurity cabinet declared war against Hamas and commenced a military campaign against Hamas. In addition, since the commencement of theseevents, there have been continued hostilities along Israel’s northern border with Lebanon (with the Hezbollah terror organization),Israel’s southern border with the Gaza Strip (with the Hamas terrorist organization) and on other fronts from various extremistgroups in region, such as the Houthis in Yemen and various rebel militia groups in Syria and Iraq. Further, on April 13, 2024, and onOctober 1, 2024, Iran launched a series of drone and missile strikes against Israel. As of June 30, 2025 a ceasefire agreement has beenreached between Israel the Hezbollah terror organization in Lebanon. On June 13, 2025, in light of continued nuclear threats and intelligenceassessments indicating imminent attacks, Israel launched a pre-emptive strike directly targeting military and nuclear infrastructureinside Iran aimed to disrupt Iran’s capacity to coordinate or launch further hostilities against Israel, as well as disrupt itsnuclear program. On June 25, 2025, a ceasefire between Israel and Iran took effect. Nonetheless, hostilities between Israel and Iranmay resume and further escalate, with both sides launching attacks against one another. The Company experienced disruptions to its workduring such period. Since June 25, 2025, The Company has been returning to full activity together with its local vendors and consultants.The Company doesn't expect a material adverse effect on its business. |
To date, the Company’s operations and financial results have not been materially affected. The Company’s operations have not been adversely affected by this situation, and it has not experienced disruptions to its clinical studies. As such, its clinical and business development activities remain on track. However, the intensity and duration of Israel’s current war against Hamas, Hezbollah and Iran is difficult to predict at this stage, as are such war’s economic implications on its business and operations and on Israel’s economy in general. If the ceasefire declared collapses or a new war commences or hostilities expand to other fronts, its operations may be adversely affected.
Note 2 — Significant accounting policies
These unaudited Condensed interim financialstatements have been prepared as of June 30, 2025 and for the six months period then ended. Accordingly, In the opinion of the Company,the accompanying unaudited condensed financial statements contain all adjustments, consisting of only normal recurring adjustments, necessaryfor a fair statement of its financial position as of June 30, 2025, and its results of operations for the six months ended June 30, 2025,and 2024, and cash flows for the same periods. The condensed balance sheet at December 31, 2024, was derived from audited annual financialstatements but does not contain all of the footnote disclosures from the annual financial statements. The significant accounting policiesthat have been applied in the preparation of the unaudited consolidated Condensed financial statements are identical to those that wereapplied in preparation of the Company’s most recent annual financial statements for the year ended December 31, 2024. These unauditedCondensed financial statements should be read in conjunction with the audited financial statements and the accompanying notes of the Companyfor the year ended December 31, 2024 that are included in the Company’s Annual Report on Form 20-F, filed with the Securities andExchange Commission on April 7, 2025 (the “Annual Report on Form 20-F”). The results of operations presented are not necessarilyindicative of the results to be expected for the year ending December 31, 2025.
F-6
NeuroSense Therapeutics Ltd.
Notes tothe Condensed Interim Unaudited Financial Statements
Note 2 — Significant accounting policies(Cont.)
Recently issued accounting pronouncements, not yet adopted
As an emerging growth company, theJumpstart Our Business Startup Act (“JOBS Act”) allows the Company to delay adoption of new or revised accounting pronouncementsapplicable to public companies until such pronouncements are made applicable to private companies. The Company has elected to use thisextended transition period under the JOBS Act.
Note 3 - Shareholders’ Equity
| a. | On August 16, 2024, the Company entered into a Capital on Demand Sales Agreement (the “Sales Agreement”) with JonesTrading Institutional Services LLC, as sales agent (the “Sales Agent”), pursuant to which the Company may offer and sell, from time to time, to or through the Sales Agent, ordinary shares, having an aggregate offering price of up to gross sale proceeds of up to $ |
| b. | On October 31, 2024, the “Company entered into astandby equity purchase agreement (the “SEPA”) with YA II PN, LTD., a Cayman Islands exempt limited partnership (“Yorkville”). |
F-7
NeuroSense Therapeutics Ltd.
Notes tothe Condensed Interim Unaudited Financial Statements
Note 3 - Shareholders’ Equity (Cont.)
Pursuant to the SEPA, the Companyhas the right, but not the obligation, to sell to Yorkville from time to time (each such occurrence, an “Advance”) up to$
| c. | During the six month period ended June 30, 2025, the Companyissued |
| d. | During the six month period ended June 30, 2025, the Companyissued |
Note 4 - Share Based Payment
On March 31, 2025, the Company’sboard of directors approved the grant of an aggregate amount of
On March 31, 2025, the Company’sboard of directors approved the grant of aggregate amount of
The following table lists the inputsused for calculation of fair value of the options granted for the six-month period ended June 30, 2025:
| June 30, 2025 | ||
| Expected volatility | ||
| Exercise price | ||
| Share price | ||
| Risk-free interest rate | ||
| Dividend yield | ||
| Expected life (years) |
F-8
NeuroSense Therapeutics Ltd.
Notes tothe Condensed Interim Unaudited Financial Statements
Note 4 - Share Based Payment (Cont.)
The share-based expense recognizedin the statements of operations were as follows:
| June 30, | ||||||||
| 2025 | 2024 | |||||||
| U.S dollars in thousands | ||||||||
| Share-based compensation expense - Research and development | $ | $ | ||||||
| Share-based compensation expense - General and administrative (*) | ||||||||
| $ | $ | |||||||
| (*) |
F-9
Exhibit 99.3
OPERATING AND FINANCIAL REVIEW AND PROSPECTS
You should read the followingselected financial data and discussion of our operating and financial condition and prospects in conjunction with the financial statementsand the notes thereto included elsewhere in this 6-K. Our financial statements are prepared in in conformity with United States of America,or U.S. GAAP. Unless otherwise indicated or the context otherwise requires, all references herein to the terms “NeuroSense,”“NeuroSense Therapeutics,” the “Company,” “we,” “us” and “our” refer to NeuroSenseTherapeutics Ltd. The term “NIS” refers to New Israeli Shekels, the lawful currency of the State of Israel, and the terms“dollar” or “$” refer to U.S. dollars, the lawful currency of the United States. Unless derived from our financialstatements or otherwise indicated, U.S. dollar translations of NIS amounts presented in this exhibit are translated using the rate ofNIS 3.372 to $1.00, based on the representative exchange rate reported by the Bank of Israel on June 30, 2025.
Forward Looking Statements
This exhibit contains forward-lookingstatements concerning among other things, our ongoing and planned product development and clinical trials; the timing of, and our abilityto make, regulatory filings and obtain and maintain regulatory approvals for our product candidates; our ability to enter into and maintainstrategic collaborations, our intellectual property position; our results of operations, cash needs; financial condition, liquidity, prospects,growth and strategies; the industry in which we operate; and the trends that may affect the industry or us. Many of the forward-lookingstatements contained in this exhibit can be identified by the use of forward-looking words such as “anticipate,” “believe,”“could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,”“potential,” “should,” “target,” “would” and other similar expressions that are predictionsof or indicate future events and future trends, although not all forward-looking statements contain these identifying words.
Forward-looking statementsare based on our management’s beliefs and assumptions and on information currently available to our management. Such statementsare subject to substantial risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-lookingstatements due to a variety of factors, including, but not limited to, those identified under the section titled “Risk Factors”in our Annual Report on Form 20-F, filed with the SEC on April 7, 2025, or the Annual Report, and our other filings with the SEC fromtime to time. These risks and uncertainties include factors relating to:
| ● | the going concern reference in our financial statements and our need for substantial additional financing to achieve our goals; |
| ● | our limited operating history and history of incurring significant losses and negative cash flows since our inception, which we anticipate will continue for the foreseeable future; |
| ● | our dependence on the success of our lead product candidate, PrimeC, including our obtaining of regulatory approval to market PrimeC in the United States (the “U.S.”); |
| ● | our limited experience in conducting clinical trials and reliance on clinical research organizations and others to conduct them; |
| ● | our ability to advance our preclinical product candidates into clinical development and through regulatory approval; |
| ● | the results of our clinical trials, which may fail to adequately demonstrate the safety and efficacy of our product candidates; |
| ● | our ability to achieve the broad degree of physician adoption and use and market acceptance necessary for commercial success; |
| ● | our reliance on third parties in marketing, producing or distributing products and research materials for certain raw materials, compounds and components necessary to produce PrimeC for clinical trials and to support commercial scale production of PrimeC, if approved; |
| ● | our receipt of regulatory clarity and approvals for our therapeutic candidates and the timing of such regulatory clarity and approvals and of other regulatory filings and approvals; |
| ● | estimates of our expenses, revenues, capital requirements and our needs for additional financing; |
| ● | our efforts to obtain, protect or enforce our patents and other intellectual property rights related to our product candidates and technologies; |
| ● | our ability to maintain the listing of our ordinary shares on Nasdaq; |
| ● | the impact of the public health, political and security situation in Israel, the U.S. and other countries in which we may obtain approvals for our products or our business; and |
| ● | the impacts on our ongoing and planned trials and manufacturing as a result of the war in Israel. |
The preceding list is notintended to be an exhaustive list of all of our risks and uncertainties. As a result of these factors, we cannot assure you that the forward-lookingstatements in this exhibit will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracymay be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statementsas a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, orat all.
In addition, statements that“we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based uponinformation available to us as of the date of the 6-K that accompanies this exhibit, and while we believe such information forms a reasonablebasis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we haveconducted an exhaustive inquiry into, or review of, all relevant information.
The forward-looking statementsand opinions contained in this exhibit are based upon information available to us as of the date of the 6-K that accompanies this exhibitand, while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, andour statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially availablerelevant information. The forward-looking statements contained in this exhibit speak only as of the date of the 6-K that accompanies thisexhibit, and unless otherwise required by law, we do not undertake any obligation to update them in light of new information or futuredevelopments or to release publicly any revisions to these statements in order to reflect later events or circumstances or to reflectthe occurrence of unanticipated events.
You should read this exhibit,and the documents that we reference herein, completely and with the understanding that our actual future results may be materially differentfrom what we expect. We qualify all of our forward-looking statements by these cautionary statements.
2
Overview
We are a clinical-stage biotechnologycompany focused on discovering and developing treatments for people living with neurodegenerative diseases, including ALS AD and PD. Webelieve these diseases represent some of the most significant unmet medical needs of our time, with limited effective therapeutic optionsavailable. The burden of these diseases on both patients and society is substantial. For example, the average annual cost of ALS aloneis $180,000 per patient, and its estimated annual burden on the U.S. healthcare system is greater than $1 billion. Due to thecomplexity of neurodegenerative diseases, our strategy is utilizing a combined therapeutic approach to target multiple disease-relatedpathways.
Our lead therapeutic candidate,PrimeC, is a novel extended-release oral formulation, fixed-dose combination of two FDA-approved drugs, ciprofloxacin and celecoxib. PrimeCis designed to treat ALS by modulating microRNA synthesis, iron accumulation, and neuroinflammation, all of which are hallmarks of ALSpathology. The U.S. Food and Drug Administration, or the FDA and the European Medicines Agency, or the EMA have granted PrimeC orphandrug designation for the treatment of ALS. In addition, the EMA has granted PrimeC the Small and Medium-Sized Enterprise, or SME,status, which offers significant potential benefits leading up to and following drug regulatory approval. We believe PrimeC’s multifunctionalmechanism of action has the potential to significantly prolong lifespan and improve ALS patients’ quality of life, thereby reducingthe burden of this debilitating disease on both patients and healthcare systems.
PrimeC was evaluated in PARADIGM,a Phase 2b randomized, multi-center, multinational, prospective, double-blind, placebo-controlled study, to evaluate safety, tolerability,and efficacy of PrimeC in 68 people living with ALS. Participants were being administered PrimeC or placebo at a 2:1 ratio, respectively,for the six-month double-blind part. Study participants were allowed to continue standard of care treatment of approved products. Theprimary endpoints of the study are an evaluation of ALS-biomarkers as well as safety and tolerability assessment. Secondary and exploratoryendpoints are the evaluation of clinical efficacy (ALS Functional Rating Scale — Revised, or ALSFRS-R, and slow vitalcapacity), survival, and improvement in quality of life. All subjects who completed the six-month double-blind, placebo-controlled dosingperiod had the opportunity to be transferred to the PrimeC active arm for a 12-month open label extension. The study completed enrollmentin May 2023, enrolling 69 participants, in which 68 are living with ALS and one participant who was misdiagnosed for ALS and wasexcluded from the evaluations. Four ALS clinical centers participated in the study in three territories: Israel, Italy, and Canada. InDecember 2023, we reported that we met the primary safety and tolerability endpoints and achieved secondary clinical efficacy endpointsin the top-line results of our 6-month double-blind phase of PARADIGM. In May 2024, we announced new positive data analysis from PARADIGMclinical trial demonstrating statistically significant slowing of disease progression in high-risk ALS patients. In July 2024, we announcedresults from the 12-month analysis of the PARADIGM clinical trial which showed a significant improvement in the rate of decline of ALSFunctional Rating Scale-Revised (ALSFRS-R) scores and survival rates for subjects who received PrimeC from the start of the trial comparedto those who started on placebo. In August 2024, we announced positive 12-month biomarker data from the PARADIGM clinical trial, whichshowed a significant decrease in ferritin levels and a corresponding increase in transferrin levels, both indicating alleviation of thepathology. In October 2024, we completed the full 18-month dosing in PARADIGM, and in December 2024, we announced results from the 18-monthanalysis of the PARADIGM clinical trial which showed statistically significant positive results from the 18-month data analysis of thePARADIGM study, evaluating the efficacy of PrimeC in the treatment of ALS. In February 2025, we announced additional findings from an18-month analysis of the PARADIGM clinical trial showing improvements in two additional endpoints, complication-free survival (analysiswhich includes death from any cause or respiratory insufficiency or hospitalization due to ALS-related complications) and Slow VitalCapacity (SVC), measuring respiratory function.
Following the FDA’srecommendation for additional non-clinical data to support long term use of Ciprofloxacin (as PrimeC is intended for long-term administrationin treating ALS) a long-term tox study was initiated.
InSeptember 2024, we announced the successful completion of the in-life phase of the study, as we move towards the initiation of a Phase3 study in the U.S.
InDecember 2024, we concluded a productive Type C meeting with the FDA. The purpose of the meeting was to discuss the design of a proposedPhase 3 clinical study and the plan for submission of an eventual 505(b)(2) marketing application. In light of the FDA’s feedback,we plan to submit a final protocol to the FDA during the second half of 2025 and approach the EMA, with the aim of commencing enrollmentof the pivotal Phase 3 study in the second half of 2025, which would include approximately 300 patients divided by a ratio of 2:1, PrimeCto placebo. The Phase 3 study is expected to be a randomized, multi-center, multinational, prospective, double-blind, placebo-controlledstudy, with an open label extension (OLE), to evaluate the efficacy and safety of PrimeC in people living with ALS. Following 12 monthsof treatment, it is expected that all participants will transition to PrimeC for a 12-month open label extension.
3
InDecember 2024, we entered into a binding term sheet with a leading global pharmaceutical company to advance the development and commercializationof PrimeC, in certain key territories. We retain full rights to PrimeC in other key territories. The binding term sheet outlinessubstantial financial terms from the pharmaceutical company, including: (i) a substantial upfront payment upon signing a definitive agreement,(ii) funding for the Phase 3 clinical trial, (iii) regulatory and net sales milestone payments, and (iv) a tiered royalty structure reachingdouble-digit percentage on annual net sales. The pharmaceutical company would have an exclusive license to distribute, market, promote,sell and develop PrimeC for ALS in certain key markets, and non-exclusive rights for research and manufacturing for PrimeC for ALS, subjectto terms and conditions in the definitive agreement. The pharmaceutical company would have an exclusive license to distribute, market,promote, sell and develop PrimeC for ALS in certain key markets, and non-exclusive rights for research and manufacturing forPrimeC for ALS, subject to terms and conditions in the definitive agreement. The closing of this transaction is subject to a definitiveagreement. While both parties are communicating to find solutions to the remaining open matters, there can be no assurance as to the timingof, or whether, such an agreement will ultimately be executed, and if executed, what would be the final terms of such an agreement.
PrimeC was previously evaluatedin a Phase IIa clinical trial, or NST002, in 15 people living with ALS, conducted at the Tel Aviv Sourasky Medical Center, Israel.The primary endpoint of the NST002 trial, which was safety and tolerability, was met. In this trial, the safety profile observed was consistentwith known safety profiles of ciprofloxacin and celecoxib. Side effects were mild and transient in nature. There were no new or unexpectedsafety signals detected during the trial.
Additionally, we observedpositive clinical signals in comparison to virtual controls, and a serum biomarker analysis showed significant changes following treatment,indicating biological activity of the drug in comparison to untreated matched ALS patients. All 12 patients who completed the NST002 trialelected to continue into an extension study with PrimeC, that was conducted as an Investigator Initiated Study. To date, we are stillsupporting the drug supply for a few of the participants in this study, which is over than 40 months since NST002 was initiated.
We completed three additionalstudies in 2022 as part of our drug development program to further support our future regulatory submissions. In April 2022, we initiateda pharmacokinetic, or PK, study, or NCT05232461, of PrimeC. The PK open-label, randomized, single-dose, three-treatment, three-periodcrossover study evaluated the effect of food on the bioavailability of PrimeC as compared to the bioavailability of co-administered ciprofloxacintablets and celecoxib capsules in adult subjects in the U.S. under an FDA cleared IND protocol.
In August 2022, we completedenrollment and dosing of all subjects in a multi-dose PK study, or NCT05436678. On September 28, 2022, we released the results ofthe NCT05436678 study. Based on results, we believe the PK profile of PrimeC supports the formulation’s extended-release properties,as the concentrations of the active components have been synchronized, aiming to potentially maximize the synergism between the two compounds.In June 2022, we reported the successful completion of the “in-life” phase of its 90-day GLP toxicology study. In thisstudy, the components of PrimeC, celecoxib and ciprofloxacin, were administered to rodents at doses 4x the maximal clinical dose. Allanimals appeared normal, with no significant findings observed. We intend to present the data from these studies to the FDA as part ofPrimeC’s drug development plan.
We believe we have a strongpatent estate, including patents on method of use, combination, and formulation. We have secured U.S. Patent 10,980,780 relating to methodsfor treatment of ALS using ciprofloxacin and celecoxib, the components of PrimeC, which expires in 2038. Equivalent patents also havebeen issued in the European Patent Office, Canada, Australia, Israel and Japan. The patent estate also includes US Patent 12,097,185,which relates to Prime C formulations. This patent will expire in December 2042. Equivalent applications are pending in many jurisdictionsworldwide. We also expect to take advantage of orphan drug exclusivity for PrimeC, if approved, for seven years in the United States andten years in the European Union. In addition, U.S. patent application 16/623,467, which relates to methods of treatment of neurodegenerativedisease using combinations of ciprofloxacin and celecoxib, is currently pending. This patent application, once granted, is expected toexpire on June 20, 2038.
4
Our organization is builtaround a management team with extensive experience in the pharmaceutical industry, with a particular focus on ALS research and clinicaltrials. We believe that our leadership team is well-positioned to lead us through clinical development, regulatory approval and commercializationof our product candidates. Furthermore, we maintain steadfast and extensive communication and collaboration with patient advocacy groupsand associations, underscoring the importance of patient perspectives in advancing therapeutic strategies.
In addition to PrimeC, weextended our pipeline and conducted research and development efforts for AD and PD, with a similar strategy of combined products. Thefollowing chart represents our current product development pipeline:
We have incurred operatinglosses in each year since our inception. We incurred net losses of $4.71 million and $6.26 million for the six months ended June30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $41.37 million. We expect to incur significantexpenses and operating losses for the foreseeable future as we advance our product candidates from formulation development through preclinicaldevelopment and clinical trials, seek regulatory approval and pursue commercialization of any approved product candidate. In addition,we expect that our expenses will increase substantially in connection with our ongoing activities as we:
| ● | continue the clinical development of PrimeC; |
| ● | continue the preclinical development of our other product candidates; |
| ● | file an NDA seeking regulatory approval for any product candidates; |
| ● | establish a sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize any products for which we obtain manufacturing approval; |
| ● | maintain, expand and protect our intellectual property portfolio; |
| ● | add equipment and physical infrastructure to support our research and development; |
| ● | hire additional clinical development, quality control and manufacturing personnel; |
| ● | incur additional expenses associated with operating as a U.S. public company, including significant legal, accounting, investor relations and other expenses that we did not incur as a private company; and |
| ● | add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization. |
5
Operating Results
Revenue
We have not recognized anyrevenue to date and we do not expect to generate revenue from the sale of products in the near future.
Operating Expenses
Our current operating expensesconsist primarily of research and development as well as general and administrative expenses.
Research and Development Expenses
Research and developmentexpenses consist primarily of:
| ● | salaries for research and development staff and related expenses, including employee benefits and share-based compensation expenses; |
| ● | expenses for production of our product candidates by contract manufacturers; |
| ● | expenses paid to contract research organizations and other third parties in connection with the performance of preclinical studies, clinical trials and related expenses; |
| ● | expenses incurred under agreements with other third parties, including subcontractors, suppliers and consultants that conduct formulation development, regulatory activities and preclinical studies; and |
| ● | expenses incurred to acquire, develop and manufacture preclinical study and clinical trial materials. |
Expenses on research activitiesis recognized in profit or loss when incurred. Development expenditures, including patent registration costs, are capitalized only ifdevelopment costs can be measured reliably, the product or process is technically and commercially feasible, future economic benefitsare probable, and we intend to and have sufficient resources to complete development and to use or sell the asset. As of June 30, 2025,no development expenditures have met the recognition criteria and thus we have expensed all of our development expenditures as incurred.
We are currently focusedon advancing our product candidates, and our future research and development expenses will depend on their clinical success. Researchand development expenses will continue to be significant and will increase over at least the next several years as we continue to developour product candidates and conduct preclinical studies and clinical trials of our product candidates.
We do not believe that itis possible at this time to accurately project total expenses required for us to reach commercialization of our product candidates. Dueto the inherently unpredictable nature of preclinical and clinical development, we are unable to estimate with certainty the costs wewill incur and the timelines that will be required in the continued development and approval of our product candidates. Clinical and preclinicaldevelopment timelines, the probability of success and development costs can differ materially from expectations. See “Risk Factors—RisksRelated to Our Business and Strategy” in our Annual Report. In addition, we cannot forecast which product candidates may besubject to future collaborations, if and when such arrangements will be entered into, if at all, and to what degree such arrangementswould affect our development plans and capital requirements.
6
General and Administrative Expenses
General and administrativeexpenses consist primarily of personnel costs, including share-based compensation, related to directors, executive, finance, and humanresource functions, insurance costs, facility costs and external professional service costs, including legal, accounting, marketing andaudit services and other consulting fees.
We anticipate that our generaland administrative expenses will increase in the future as we increase our administrative headcount and infrastructure to support ourcontinued research and development programs and the potential approval and commercialization of our product candidates. We also anticipatethat we will incur increased expenses related to audit, legal, regulatory and tax-related services associated with maintaining compliancewith Nasdaq and SEC requirements, director and officer insurance premiums, director compensation, and other costs associated with beinga public company.
In addition, if any of ourproduct candidates receives regulatory approval and if we determine to invest in building a commercial infrastructure to support the marketingof our products, we expect to incur greater expenses.
Financing income (Expenses), net
Our net financing expenses(income), net consist primarily of fair value revaluation of warrants, issuance costs, interest income on deposits, interest expenseson lease liability and differences in the exchange rate between NIS and the U.S. Dollar.
Income Taxes
We have yet to generate taxableincome in Israel, as we have historically incurred operating losses resulting in carry forward tax losses totaling approximately $24.7million as of June 30, 2025. We anticipate that we will continue to generate tax losses for the foreseeable future and that we will beable to carry forward these tax losses indefinitely to future taxable years. Accordingly, we do not expect to pay taxes in Israel untilwe have taxable income after the full utilization of our carry forward tax losses.
Results of Operations
Our results of operationsfor the six months ended June 30, 2025 and 2024 were as follows:
| For the Six Months Ended June 30, | ||||||||
| (U.S. dollars in thousands except share and per share data) | 2025 | 2024 | ||||||
| Statement of Operations: | ||||||||
| Research and Development Expenses | (2,503 | ) | (3,733 | ) | ||||
| General and Administrative Expenses | (2,189 | ) | (2,291 | ) | ||||
| Operating Loss | (4,692 | ) | (6,024 | ) | ||||
| Financing expense, net | (17 | ) | (237 | ) | ||||
| Net Loss and Comprehensive Loss | (4,709 | ) | (6,261 | ) | ||||
| Basic and Diluted Net Loss per Share | (0.19 | ) | (0.37 | ) | ||||
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 25,402,649 | 16,773,806 | ||||||
7
Research and Development Expenses
The following table describesthe breakdown of our research and development expenses for the indicated periods:
| For the Six Months Ended June 30, | ||||||||
| (U.S. dollars in thousands except share and per share data) | 2025 | 2024 | ||||||
| Subcontractors and consultants | $ | 1,547 | 2,571 | |||||
| Share-based compensation | 18 | 154 | ||||||
| Salaries and social benefits | 938 | 1,008 | ||||||
| Total research and development expenses | $ | 2,503 | 3,733 | |||||
Our research and developmentexpenses for the six months ended June 30, 2025 and 2024 were $2,503 thousand and $3,733 thousand, respectively. The decrease of $1,230thousand, or 32.9%, was mainly attributed to the decrease in clinical activity.
General and Administrative Expenses
The following table describesthe breakdown of our general and administrative expenses for the indicated periods:
| For the Six Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| U.S. dollars in thousands | ||||||||
| Professional services | $ | 1,034 | 1,155 | |||||
| Share-based compensation | 288 | 152 | ||||||
| Salaries and social benefits | 316 | 441 | ||||||
| Insurance | 160 | 157 | ||||||
| Traveling abroad | 110 | 83 | ||||||
| Others | 281 | 303 | ||||||
| $ | 2,189 | 2,291 | ||||||
Our general and administrativeexpenses for the six months ended June 30, 2025 and 2024 were $2,189 thousand and $2,291 thousand, respectively. The decrease of $102thousand, or 4.4%, is considered immaterial.
Financing Expenses, net
Our financing expenses, netfor the six months ended June 30, 2025 and 2024, were $17 thousand and $237 thousand, respectively. The decrease of $220 thousand, or92.8%, was mainly attributed to change in fair value revaluation expenses.
8
Liquidity and Capital Resources
Overview
Since our inception, we haveincurred losses and negative cash flows from our operations. For the six months ended June 30, 2025, we incurred a net loss of $4.71 millionwhile net cash of $4.0 million was used in our operating activities. As of June 30, 2025, we had a negative working capital of $0.64 million,and an accumulated deficit of $41.37 million. As of June 30, 2025, our cash totaled approximately $0.66 million.
Our financial statementshave been prepared on a going concern basis under which an entity is considered to be able to realize its assets and satisfy its liabilitiesin the ordinary course of business, and our financial status creates a doubt whether we will continue as a going concern. Our future operationsare dependent upon the identification and successful completion of equity or debt financing and the achievement of profitable operationsat an indeterminate time in the future. There can be no assurances that we will be successful in completing an equity or debt financingor in achieving or maintaining profitability. The financial statements do not give effect to any adjustments relating to the carryingvalues and classification of assets and liabilities that would be necessary should we be unable to continue as a going concern.
Through June 30, 2025, wehave financed our operations primarily through our initial public offering, public and private offerings of our equity securities, proceedsfrom the exercise of warrants and options, and crowd funding of equity securities. Total gross invested capital as of June 30, 2025 wasapproximately $37.2 million, which included ordinary shares, SAFE agreements, options and warrants to purchase ordinary shares.
Cash flows
The following table summarizesour statement of cash flows for the six months ended June 30, 2025 and 2024:
| For the Six Months Ended June 30, | ||||||||
| (U.S. dollars in thousands except share and per share data) | 2025 | 2024 | ||||||
| Net cash used in operating activities and exchange rates | $ | (4,000 | ) | (5,750 | ) | |||
| Net cash used in investing activities | (13 | ) | 1 | |||||
| Net cash provided by financing activities | 1,301 | 4,317 | ||||||
| (Decrease) increase in cash and cash equivalents | $ | (2,712 | ) | (1,432 | ) | |||
Net cash used in operating activities
Net cash used in operatingactivities was $4,000 thousand and $5,750 thousand for the six months ended June 30, 2025 and 2024, respectively. The decrease of $1,750thousand was mainly attributable to decrease in our net loss for the period.
Net cash provided by (used in) investing activities
Net cash provided by (usedin) investing activities was $(13) thousand and $1 thousand for the six months ended June 30, 2025 and 2024, respectively. The decreaseof $14 thousand was mainly attributed to change in restricted deposit and purchase of property and equipment.
Net cash provided by financing activities
Net cash provided by financingactivities was $1,301 thousand and $4,317 thousand for the six months ended June 30, 2025 and 2024, respectively. The decrease of $3,016thousand was mainly attributed to lower proceeds from issuance of shares.
9
Funding Requirements
Since our inception, almostall of our resources have been dedicated to the preclinical and clinical development of our lead product candidate, PrimeC. As of June30, 2025, we had cash of $0.66 million.
Our present and future fundingrequirements will depend on many factors, including, among other things:
| ● | the progress, timing and completion of clinical trials for PrimeC; |
| ● | preclinical studies and clinical trials for our other product candidates; |
| ● | the costs related to obtaining regulatory approval for PrimeC and any of our other product candidates, and any delays we may encounter as a result of regulatory requirements or adverse clinical trial results with respect to any of these product candidates; |
| ● | selling, marketing and patent-related activities undertaken in connection with the commercialization of PrimeC and any of our other product candidates, and costs involved in the development of an effective sales and marketing organization; |
| ● | the costs involved in filing and prosecuting patent applications and obtaining, maintaining and enforcing patents or defending against claims or infringements raised by third parties, and license royalties or other amounts we may be required to pay to obtain rights to third party intellectual property rights; |
| ● | potential new product candidates we identify and attempt to develop; and |
| ● | revenues we may derive either directly or in the form of royalty payments from future sales of PrimeC and any other product candidates. |
For more information as tothe risks associated with our future funding needs, see “Risk Factors — Our financial statements include a going concernreference. We will require substantial additional financing to achieve our goals, and a failure to obtain this capital when neededand on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development, commercialization effortsor other operations.” in our Annual Report.
Contractual Obligations and Commitments
As of June 30, 2025, we didnot have any material contractual obligation and commitments, except for lease agreements with respect to offices. In December 2021, weentered into an office space lease agreement in Herzilya, Israel (which commenced on January 1, 2022). Monthly rent payments includingutilities amount to approximately $7 thousand and are indexed to CPI. The lease period was for 24 months with an option to extend thelease period for additional two periods of 24 months each. We exercised the first period option, and we expect to exercise the secondoption for an additional lease period.
Off-Balance Sheet Arrangements
We did not have during theperiods presented, and we do not currently have, any off-balance sheet arrangements that have or are reasonably likely to have a currentor future effect on our financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.
10