RegistrationNo. 333-          

UNITEDSTATES

SECURITIESAND EXCHANGE COMMISSION

Washington,D.C. 20549

FORMS-1

REGISTRATIONSTATEMENT UNDER THE SECURITIES ACT OF 1933

CalidiBiotherapeutics, Inc.

(Exactname of registrant as specified in its charter)

4475Executive Drive, Suite 200,

SanDiego, California 92121

Telephone:(858) 794-9600

(Address,including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Dr.Eric Poma

ChiefExecutive Officer

CalidiBiotherapeutics, Inc.

4475Executive Drive, Suite 200,

SanDiego, CA 92121

Telephone:(858) 794-9600

(Name,address, including zip code, and telephone number, including area code, of agent for service)

Copiesto:

Approximatedate of commencement of proposed sale to the public: From time to time after the effective date of this registration statement.

Ifany of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under theSecurities Act of 1933 check the following box. ☒

Ifthis Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check thefollowing box and list the Securities Act registration statement number of the earlier effective registration statement for the sameoffering. ☐

Ifthis Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list theSecurities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Ifthis Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list theSecurities Act registration statement number of the earlier effective registration statement for the same offering. ☐

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

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 7(a)(2)(B) of the Securities Act. ☐

Theregistrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until theregistrant shall file a further amendment which specifically states that this registration statement shall thereafter become effectivein accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such dateas the Commission, acting pursuant to said Section 8(a), may determine.

Theinformation in this prospectus is not complete and may be changed. These securities may not be sold until the registrationstatement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securitiesnor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

6,355,650Shares of Common Stock

Thisprospectus relates to the resale or other disposition from time to time by the selling stockholders identified herein (each, a “SellingStockholder” and, together, the “Selling Stockholders”), in this prospectus of Calidi Biotherapeutics, Inc. (the “Company”)of: (i) 6,053,000 shares of common stock, par value $0.0001 per shares (“Common Stock”) issuable on the exercise of SeriesG common warrants, exercisable at an exercise price of $0.6954 per share, first exercisable on September 28, 2025 and expiring on March28, 2033; and (ii) 302,650 shares of Common Stock issued to Ladenburg Thalmann & Co., Inc. (“Ladenburg”) (or its designees),as placement agent in the public offering placement deal, exercisable at an exercise price of $0.8125 per share, first exercisable onSeptember 28, 2025 and expiring on September 28, 2030. For further information with respect to the issuance of such shares of CommonStock, see the section “Unregistered Sales of Common Stock” beginning on page 68 of this prospectus.

Wewill not receive any of the proceeds from the sale of Common Stock by the Selling Stockholders. However, upon any exercise of the warrants(specified herein and held by the Selling Stockholders) by payment of cash, we will receive the exercise price of such warrants.

TheSelling Stockholders may sell or otherwise dispose of the Common Stock covered by this prospectus in a number of different ways and atvarying prices. We provide more information about how the Selling Stockholders may sell or otherwise dispose of the Common Stock coveredby this prospectus in the section entitled “Plan of Distribution” on page 152 of this prospectus. For information on theSelling Stockholders, see the section entitled “Selling Stockholders” on page 68 of this prospectus. Discounts, concessions,commissions and similar selling expenses attributable to the sale of Common Stock covered by this prospectus will be borne by the SellingStockholders. We will pay all expenses (other than discounts, concessions, commissions and similar selling expenses) relating to theregistration of the Common Stock with the Securities and Exchange Commission, or the SEC.

Ourcommon stock is listed on the NYSE American LLC under the symbol “CLDI.” On July 2, 2025, the last reported sale price pershare of our common stock was $0.2339.

Wemay amend or supplement this prospectus from time to time by filing amendments or supplements as required. You should read the entireprospectus and any amendments or supplements carefully before you make your investment decision.

Weare an “emerging growth company” and a “smaller reporting company” under applicable Securities and Exchange Commission(“SEC”) rules and, as such, have elected to comply with certain reduced public company disclosure requirements for this prospectusand future filings. See the discussions in the section titled “Summary – Implications of Being an Emerging Growth Companyand a Smaller Reporting Company.”

Investingin our securities involves a high degree of risk. You should review carefully the risks and uncertainties described in the section entitled“Risk Factors” beginning on page 10 of this prospectus, and under similar headings in any amendments or supplementsto this prospectus.

Neitherthe Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passedupon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.

Thedate of this prospectus is     , 2025.

TABLEOF CONTENTS

ABOUTTHIS PROSPECTUS

Youmay only rely on the information contained in this prospectus or that we have referred you to. We have not authorized anyone to provideyou with information different from, or in addition to, that contained in this prospectus. This prospectus does not constitute an offerto sell or a solicitation of an offer to buy any securities other than the common stock offered by this prospectus. This prospectus doesnot constitute an offer to sell or a solicitation of an offer to buy any common stock in any circumstances in which such offer or solicitationis unlawful. Neither the delivery of this prospectus nor any sale made in connection with this prospectus shall, under any circumstances,create any implication that there has been no change in our affairs since the date of this prospectus. For investors outside the UnitedStates: Neither we nor the selling stockholders have done anything that would permit this offering or possession or distribution of thisprospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the UnitedStates who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offeringof the shares of common stock and the distribution of this prospectus outside the United States.

Unlessthe context otherwise requires, “we,” “us,” “our,” “registrant,” or “Registrant,”“Calidi,” “Calidi Biotherapeutics,” and the “Company” refer to Calidi Biotherapeutics, Inc., a Delawarecorporation (f/k/a First Light Acquisition Group, Inc., a Delaware corporation), and its consolidated subsidiaries following the BusinessCombination. Unless the context otherwise requires, references to “FLAG” refer to First Light Acquisition Group, Inc., aDelaware corporation, prior to the Business Combination. Unless the context otherwise requires, references to “Calidi NV”means Calidi Biotherapeutics (Nevada), Inc. (formerly Calidi Biotherapeutics, Inc.), a Nevada corporation and our wholly-owned subsidiary.In addition, unless the context otherwise requires, “common stock” or “Common Stock” refer to our voting commonstock, and “Escalation Shares” and Non-Voting Escalation Shares” refer to our Non-Voting Common Stock held in escrow.

MARKETAND INDUSTRY DATA

Thisprospectus contains statistical data, estimates and information concerning our industry, including market position and the size and growthrates of the markets in which we participate, that are based on independent industry publications and reports or other publicly availableinformation, as well as other information based on our internal sources. Although we believe the market and industry data included inthis prospectus are reliable and are based on reasonable assumptions, these data involve many assumptions and limitations, and you arecautioned not to give undue weight to these estimates. We have not independently verified the accuracy or completeness of the data containedin these industry publications and reports. The industry in which we operate is subject to a high degree of uncertainty and risk dueto a variety of factors, including those described in the sections entitled “Risk Factors” and “CautionaryNote Regarding Forward-Looking Statements.” These and other factors could cause results to differ materially from those expressedin these publications and reports.

Certaininformation included in this prospectus concerning our industry and the markets served by us, including our market share, is also basedon our good-faith estimates derived from our management’s knowledge of the industry and other information currently available tous.

CAUTIONARYNOTE REGARDING FORWARD-LOOKING STATEMENTS

Thisprospectus contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (“SecuritiesAct”) and Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”). These forward-looking statementsinclude, among other things, statements regarding our and our management team’s expectations, hopes, beliefs, intentions or strategiesregarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events orcircumstances, including any underlying assumptions, are forward-looking statements. Forward-looking statements are typically identifiedby words such as “plan,” “believe,” “expect,” “anticipate,” “intend,” “outlook,”“estimate,” “forecast,” “project,” “continue,” “could,” “may,”“might,” “possible,” “potential,” “predict,” “should,” “would,”“will,” “seek,” “target,” and other similar words and expressions, but the absence of these wordsdoes not mean that a statement is not forward-looking. Forward-looking statements in this prospectus may include, for example, statementsabout:

Theforward-looking statements contained in this prospectus are based on our current expectations and beliefs concerning future developmentsand their potential effects on our business. There can be no assurance that future developments affecting our business will be thosethat we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control)or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by theseforward-looking statements. These risks and uncertainties include, but are not limited to, those factors described in the section entitled“Risk Factors.” Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertaintiesemerge from time to time and it is not possible for us to predict all such risk factors, nor can we assess the effect of all such riskfactors on our business or the extent to which any factor or combination of factors may cause actual results to differ materially fromthose contained in any forward-looking statements. Should one or more of these risks or uncertainties materialize, or should any of theassumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements.

Theforward-looking statements made by us in this prospectus speak only as of the date of this prospectus. Except to the extent requiredunder the federal securities laws and rules and regulations of the Securities and Exchange Commission (“SEC”), we disclaimany obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is madeor to reflect the occurrence of unanticipated events. In light of these risks and uncertainties, there is no assurance that the eventsor results suggested by the forward-looking statements will in fact occur, and you should not place undue reliance on these forward-lookingstatements.

SELECTEDDEFINITIONS

Unlessthe context otherwise requires or has otherwise been defined, the following defined terms shall have the meaning set forth below.

“anchorinvestors” means certain unaffiliated qualified institutional buyers or institutional accredited investors who have each enteredinto an Investment Agreement pursuant to which such anchor investors have purchased in the aggregate 145,265 founder shares from ourSponsor and Metric at approximately $0.04 per share;

“BusinessCombination” means the business combination of FLAG with Calidi pursuant to the terms and conditions of the Merger Agreement;

“Bylaws”means the Amended and Restated Bylaws, as amended, in effect as of the date of this prospectus;

“Calidi”or “Calidi Biotherapeutics” means Calidi Biotherapeutics, Inc., a Delaware corporation;

“Charter”or “Second Amended and Restated Certificate of Incorporation” means the Second Amended and Restated Certificate ofIncorporation in effect;

“Closing”means the closing of the Merger and all of the transactions contemplated by the Merger Agreement in accordance with the terms of theMerger Agreement;

“ClosingDate” means the date on which the Business Combination was consummated which occurred on September 12, 2023;

“commonstock” or “Common Stock” means Calidi Common Stock following the Business Combination, with the rights and preferencesand subject to the terms and conditions set forth in the Charter;

“DGCL”means the Delaware General Corporation Law, as amended;

“ExchangeAct” means the Securities Exchange Act of 1934, as amended;

“FLAG”means First Light Acquisition Group, Inc., a Delaware corporation;

“InvestmentAgreement” means each of the investment agreements entered into between our Sponsor, Metric and the anchor investors pursuantto which such anchor investors have purchased in the aggregate 145,265 founder shares from our Sponsor and Metric at approximately $0.04per share;

“Metric”means Metric Finance Holdings I, LLC, a Delaware limited liability company and an affiliate of Guggenheim Securities, LLC;

“CommonStock” or “common stock” means, following the consummation of the Business Combination, the common stock, par value$0.0001 per share, of Calidi Biotherapeutics, Inc.;

“RegistrationRights Agreements” mean certain agreements requiring the Company to register the holders’ shares of common stock withthe Securities and Exchange Commission consisting of that certain (i) Amended And Restated Registration Rights Agreement dated September12, 2023; (ii) Voting and Lock-Up Agreement dated as of January 9, 2023, and amended on April 12, 2023, and (iii) Series B PreferredStock Investors’ Rights Agreement dated June 16, 2023;

“SeriesB Financing” means the equity financing contemplated by the Securities Purchase Agreements between Calidi Biotherapeutics,Inc., and Jackson Investment Group, LLC and Calidi Cure, LLC, dated June 16, 2023, to secure commitments for the purchase of Series BConvertible Preferred Stock of Calidi;

“Sponsor”means First Light Acquisition Group, LLC, a Delaware series limited liability company; and

“SponsorShares” means 552,709 shares of common stock (net of cancellations from the original 575,000 shares of common stock sold) inthe aggregate originally sold to the Sponsor and Metric at $0.04 per share, and subsequently sold to the anchor investors at the samepurchase price or transferred other shareholders as an inducement to complete and finance the Business Combination.

PROSPECTUSSUMMARY

Thefollowing summary highlights selected information contained elsewhere in this prospectus. This summary is not complete and does not containall of the information you should consider before investing in our securities. You should read this entire prospectus carefully, includingthe sections entitled “Risk Factors,” “Cautionary Note Regarding Forward-Looking Statements,” and “Management’sDiscussion and Analysis of Financial Condition and Results of Operations,” and our consolidated financial statements and the relatednotes included elsewhere in this prospectus, before making an investment decision.

TheCompany is in the process of obtaining stockholder approval for a reverse stock split in a ratio ranging between 1-for-2 to 1-for-19,with the final ratio to be approved by the Board. Once such stockholder approval is obtained and the Company effectuates a reverse stocksplit, all historical per share data, number ofshares issued and outstanding, stock awards, and other common stock equivalents set forth herein relating to our common stock willbe adjusted to give effect to such reverse stock split.

CompanyOverview

Weare a clinical stage biotechnology company that is developing genetic medicines and proprietary genetically-engineered oncolyticviruses. We are currently developing RedTail, an enveloped vaccinia virus platform designed to deliver genetic medicine to tumorsites, and two proprietary stem cell-based oncolytic virus platforms (SuperNova and NeuroNova). The RedTail platform is expected tocommence a Phase I trial by the end of 2026 with the first compound (CLD-401) delivering IL-15 superagonist to the tumormicroenvironment (“TME”).

OurRedTail platform is the culmination of a over a decade of work around genetic engineering of viruses and allows for the systemic administrationof a proprietarily-modified oncolytic virus that can:

OurSuperNova and NeuroNova platforms are designed to:

Oncolyticviruses have been pursued as therapeutic platforms in oncology because of their ability to preferentially infect and replicate withincancer cells, resulting in both direct lysis of the tumor cells as well as activation of an antitumor immune response, while leavingnormal, healthy cells unharmed. Despite the promises of oncolytic viruses, a major obstacle against their therapeutic use has been theirrapid elimination by the patient’s immune system; this has meant that oncolytic viruses have been largely relegated to being usedfor local delivery to tumors but have not been successful in patients with extensive metastatic disease. The only approved oncolyticvirus therapy is T-VEC (Imlygic®), a modified herpes simplex virus (HSV) for the treatment of patients with melanoma given intratumorally.

Wehave been working on protecting oncolytic virusesfrom immune clearance for over a decade. Our NeuroNova investigational drug candidate is currently in a Phase 1 trial being run byour partner, City of Hope, in an investigator-initiated trial and we have an open IND for a Phase 1 trial for our SuperNova investigationaldrug candidate. The platforms used in NeuroNova and SuperNova use oncolytic viruses embedded in stem cells to avoid immune clearanceand facilitate initial viral amplification and expansion at the tumor sites. This approach has shown substantial benefit over unprotectedvirus in preclinical studies of intratumoral delivery, but stem cell encapsulation does not allow for systemic delivery of virus to tumormetastases in animal models. The size of the stem cells prohibited efficient dissemination into metastatic sites.

Morerecently, we used the learnings from NeuroNova and SuperNova to create RedTail, a novel oncolytic viral platform for systemicdelivery. The virus used in RedTail has been proprietarily engineered to avoid immune clearance and to specifically replicate in tumortissue where the virus also has the ability to deliver genetic medicines to the tumor microenvironment. RedTail utilizes a proprietaryform of enveloped virus with genetic modifications to avoid immune clearance. Because the virus is not encapsulated in stem cells, itis thousands of times smaller than the NeuroNova or SuperNova products and disseminates efficiently into metastatic sites in syngeneicanimal models. In addition, the virus can be engineered to express genetic medicines while replicating in the tumor.

CLD-401,the first lead derived from the RedTail platform, expresses IL-15 superagonist at high concentrations in the tumor microenvironment.In animal models, CLD-401 can be given systemically and clear metastatic sites in syngeneic tumor mouse models. The combination ofthe RedTail virus with its genetic payload drives complete tumor eradication in the tumor models compared to the RedTail virus alone.We believe that RedTail, given its systemic administration and targeting to metastatic sites and its delivery of geneticmedicines, represents a major advancement in the space of oncolytic virus in oncology.

RecentDevelopments

OnApril 17, 2025, Allan Camaisa notified the Board of Calidi Biotherapeutics, Inc. (the “Company”) of his resignation as theCompany’s Chief Executive Officer and as Chairman of the Board and from all his positions with the Companies subsidiaries (exceptNova Cell, Inc.), effective April 21, 2025, subject to finalization of the terms of the General Release of Claims and Transition Agreement,which agreement was fully-executed on April 22, 2025. Mr. Camaisa will continue to serve as a Class III director of the Company, andhas assumed the title of “CEO Emeritus”. Mr. Camaisa would also continue to serve as a director on the board of directorsof our subsidiary Nova Cell, Inc. Mr. Camaisa’s resignation was not the result of any disagreement with the Company or its Boardor any matter relating to the Company’s operations, policies, or practices.

OnApril 22, 2025, the Company executed a General Release of Claims and Transition Agreement (“Release Agreement”) with Mr.Camaisa. The Release Agreement contains customary protections, including a general release of claims by Mr. Camaisa in favor of the Companyand certain other related parties. Pursuant to the terms of the Release Agreement, the Company is obligated to pay Mr. Camaisa $500,000separation pay in the form of compensation continuation over 12 months pursuant to the Company’s regular and customary payrollschedule, less all regular and customary payroll withholdings and shall also be liable to pay Mr. Camaisa’s COBRA premiums for12 months, commencing May 2025, upon timely election. Mr. Camaisa is also entitled to receive a transition/ consulting pay of $10,000per month during the transition period, and may also be entitled to incentive payments for opportunities that Mr. Camaisa has developed,as more specifically described in the Release Agreement. Such incentive will be calculated and paid based on revenues, capital, or moniesactually received by the Company on or before December 31, 2026. No incentive will be earned or paid for revenues, capital, or moniesthat are received by the Company after that date. Mr. Camaisa will not receive compensation as a member of the Board during the periodthat he receives consideration pursuant to the Release Agreement.

OnApril 17, 2025, the Board, by a unanimous vote, appointed Eric Poma, Ph.D. to serve as CEO of the Company, effective April 22, 2025.In addition, on April 22, 2025, the Board, upon recommendation of the Nominating and Corporate Governance Committee of the Board, appointedDr. Poma to serve as a Class I director of the Company, also effective April 22, 2025, with a term expiring at the annual meeting ofstockholders to be held in 2027.

OnApril 22, 2025, the Board appointed James Schoeneck as chairman of the Board, effective April 22, 2025, to serve until his successoris duly elected and qualified, or until his earlier resignation or removal. As previously disclosed, Mr. Schoeneck has served on theBoard since September 12, 2023.

OnJune 11, 2025, the Board accepted the resignation of Mr. Camaisa as the sole director and officer of Nova Cell, and approved the appointmentof Dr. Poma as the sole director and officer of Nova Cell.

CorporateBackground

Ourprincipal executive offices are located at 4475 Executive Drive, Suite 200, San Diego, California 92121. Our telephone number is (858)794-9600. Our website address is www.calidibio.com. The references to our website in this prospectus are inactive textual referencesonly. The information on our website is neither incorporated by reference into this prospectus nor intended to be used in connectionwith this offering. We have included our website address in this prospectus as an inactive textual reference only and not as an activehyperlink.

Weand our subsidiaries own or have rights to trademarks, trade names and service marks that we use in connection with the operation ofour business, including “Calidi,” Calidi Biotherapeutics,” “SuperNova, “NeuroNova,” “SNV-1,”“ SNV,” “NNV,” “NNV1,” and “NNV2.” In addition, our names, logos and website names andaddresses are our trademarks or service marks. Other trademarks, trade names and service marks appearing in this prospectus are the propertyof their respective owners. Solely for convenience, in some cases, the trademarks, trade names and service marks referred to in thisprospectus are listed without the applicable ^®, ^™ and SM symbols.

Summaryof Risk Factors

Ourbusiness is subject to numerous risks and uncertainties, including those described in the section entitled “Risk Factors,”that represent challenges that we face in connection with the successful implementation of our strategy and growth of our business. Theoccurrence of one or more of the events or circumstances described in the section entitled “Risk Factors,” alone or in combinationwith other events or circumstances, may adversely affect our ability to realize the anticipated benefits of the Business Combinationand may harm our business. Such risks include, but are not limited to, the following:

●We are a clinical-stage biotechnology company with a limited operating history and has not generated any revenue to date from productsales;

●We have incurred significant operating losses since our inception, and we anticipate that we will incur continued losses for the foreseeablefuture;

●We have no products approved for commercial sale and have not generated any revenue from product sales;

●Our engineered RedTail enveloped virus platform and our allogeneic stem cell virus product candidates represent a novel approach to cancertreatment that creates significant challenges;

●Our engineered allogeneic stem cell product candidates represent a novel approach to cancer treatment that creates significant challenges.

●Adverse publicity regarding stem cell-based immunotherapy could have a material adverse impact on our business.

●We need to raise substantial additional funding. If we are unable to raise capital when needed, or if at all, we would be forced to delay,reduce or eliminate some or all of our product development programs or cease operations altogether.

●Our business is highly dependent on the success of our RedTail platform and our SuperNova and NeuroNova compounds. If we are unable toeffectively commercialize any of these product candidates for the treatment of patients in its approved indications, our business wouldbe significantly harmed.

●Our preclinical studies and clinical trials may fail to demonstrate adequately the safety and efficacy of any of our product candidates,which would prevent or delay development, regulatory approval, and commercialization.

●Interim, top line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patientdata become available and are subject to regulatory audit and verification procedures that could result in material changes in the finaldata;

●Results of earlier studies and trials of our product candidates may not be predictive of future trial results.

●Our product candidates are based on a novel approach to the treatment of cancer which makes it difficult to predict the time and costof product candidate development and subsequently obtaining regulatory approval, if at all.

●We may develop our product candidates in combination with other therapies, which exposes us to additional risks related to other agentsor active pharmaceutical or biological ingredients used in combination with our product candidates.

●Negative developments in the field of immuno-oncology and, in particular, oncolytic viral immunotherapy, could damage public perceptionof any of our product candidates and negatively affect our business.

●Difficulty in enrolling patients could delay or prevent clinical trials of our product candidates, and ultimately delay or prevent regulatoryapproval.

●Even if we receive marketing approval for our current or future product candidates, our current or future product candidates may notachieve broad market acceptance, which would limit the revenue that we generate from their sales.

●We face substantial competition, which may result in others discovering, developing or commercializing product candidates before or moresuccessfully than we do.

●The regulatory approval processes of the FDA and other regulatory authorities are lengthy, time consuming and inherently unpredictable.If we are not able to obtain, or experience delays in obtaining, required regulatory approvals, we will not be able to commercializeour current and future product candidates as expected, and our ability to generate revenue may be materially impaired.

●A Breakthrough Therapy designation by the FDA, even if granted for any of our product candidates, may not lead to a faster developmentor regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval.

●Accelerated approval by the FDA, even if granted for certain of our current or future product candidates, may not lead to a faster developmentor regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval.

●Even if our development efforts are successful, we may not obtain regulatory approval of our current or any future product candidatesin the United States or other jurisdictions, which would prevent us from commercializing our current and future product candidates. Evenif we obtain regulatory approval for our current and future product candidates, any such approval may be subject to limitations, includingwith respect to the approved indications or patient populations, which could impair our ability to successfully commercialize our currentor any future product candidates.

●Changes in product candidate manufacturing or formulation may result in additional costs or delay.

●Inadequate funding for the FDA, the SEC and other government agencies, including from government shutdowns, or other disruptions to theseagencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products andservices from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal businessfunctions on which the operation of our business may rely, which could negatively impact our business.

●Even if our current or any future product candidates receive regulatory approval, we will be subject to ongoing obligations and continuedregulatory review, which may result in significant additional expense and limit how we manufacture and market our products.

●Regulatory approval by the FDA or other regulatory authorities is limited to those specific indications and conditions for which approvalhas been granted, and we may be subject to substantial fines, criminal penalties, injunctions or other enforcement actions if we aredetermined to be promoting the use of our products for unapproved or “off-label” uses, or in a manner inconsistent with theapproved labeling, resulting in damage to our reputation and business.

●Physicians may choose to prescribe products for uses that are not described in the product’s labeling and for uses that differfrom those tested in clinical trials and approved by the regulatory authorities. Regulatory authorities in the United States generallydo not restrict or regulate the behavior of physicians in their choice of treatment within the practice of medicine. Regulatory authoritiesdo, however, restrict communications by biopharmaceutical companies concerning off-label use.

●We may not be able to file INDs or IND amendments to commence additional clinical trials on the timelines we expect, and even if we areable to, the FDA or other regulatory authority may not permit us to proceed.

●If approved, our investigational products regulated as biologics may face competition from biosimilars approved through an abbreviatedregulatory pathway.

●Healthcare reform measures may have a material adverse effect on our business and results of operations.

●If we fail to develop additional product candidates, our commercial opportunity could be limited.

●Our relationships with customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcarelaws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion from government healthcare programs, contractualdamages, reputational harm and diminished profits and future earnings.

●If we fail to comply with the continued listing standards of the NYSE American, our common stock could be delisted. If it is delisted,the market value and the liquidity of our common stock would be impacted.

Implicationsof Being an Emerging Growth Company

Weare an “emerging growth company,” as defined in Section 2(a) of the Securities Act of 1933, as amended (the “SecuritiesAct”), as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and we may take advantage ofcertain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies,including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-OxleyAct of 2002 (the “Sarbanes-Oxley Act”); reduced obligations with respect to financial data, including presenting only twoyears of audited financial statements in addition to any required unaudited interim financial statements, with correspondingly reduced“Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure; reduced disclosureobligations regarding executive compensation in our periodic reports, proxy statements and registration statements; exemptions from therequirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute paymentsnot previously approved; and an exemption from compliance with the requirement of the Public Company Accounting Oversight Board (the“PCAOB”) regarding the communication of critical audit matters in the auditor’s report on the financial statements.

Inaddition, pursuant to the JOBS Act, as an emerging growth company we have elected to take advantage of an extended transition periodfor complying with new or revised accounting standards. This effectively permits us to delay adoption of certain accounting standardsuntil those standards would otherwise apply to private companies. As a result, our consolidated financial statements may not be comparableto companies that comply with new or revised accounting pronouncements as of the public company effective dates.

Wemay take advantage of these provisions until the last day of our fiscal year following the fifth anniversary of the consummation of FLAG’sIPO on September 14, 2021. We will remain an emerging growth company until the earlier of: (1) the last day of the fiscal year (a) followingthe fifth anniversary of the completion of FLAG’s IPO, (b) in which we have total annual gross revenue of at least $1.235 billion,or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by non-affiliatesexceeds $700 million as of the end of the prior fiscal year’s second fiscal quarter; and (2) the date on which we have issued morethan $1.0 billion in non-convertible debt during the prior three-year period. References herein to “emerging growth company”shall have the meaning associated with it in the JOBS Act.

Implicationsof Being a Smaller Reporting Company

Asa “smaller reporting company,” as defined in Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the “ExchangeAct”), in addition to providing reduced disclosure about our executive compensation arrangements and business developments, amongother reduced disclosure requirements available to smaller reporting companies, we present only two years of audited financial statementsin addition to any required unaudited interim financial statements with correspondingly reduced “Management’s Discussionand Analysis of Financial Condition and Results of Operations” disclosure. We have taken advantage of reduced reporting requirementsin this prospectus. Accordingly, the information contained herein may be different from the information you receive from other publiccompanies in which you hold stock.

THEOFFERING

Unlessotherwise indicated, all information in this prospectus assumes:

RISKFACTORS

Aninvestment in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described below,together with all of the other information in this prospectus, including the section titled “Management’s Discussion andAnalysis of Financial Condition and Results of Operations” and our consolidated financial statements and related notes includedherein, before making an investment decision in our securities. Our business, results of operations, financial condition, and prospectscould also be harmed by risks and uncertainties that are not presently known to us or that we currently believe are not material. Ifany of the risks actually occur, our business, results of operations, financial condition, and prospects could be materially and adverselyaffected. Unless otherwise indicated, references in these risk factors to our business being harmed will include harm to our business,reputation, brand, financial condition, results of operations, and prospects. In such event, the market price of our securities coulddecline. You also should read the section entitled “Special Note Regarding Forward Looking Statements” above for a discussionof what types of statements are forward-looking statements, as well as the significance of such statements in the context of this prospectus.

RisksRelated to Our Business, Financial Position and Capital Requirements

Weare a clinical-stage biotechnology company with a limited operating history and have not generated any revenue to date from product sales.

Biopharmaceuticalproduct development is a highly speculative undertaking and involves a substantial degree of risk. Since inception, we have focused substantiallyall of our efforts and financial resources on raising capital and developing our initial product candidates. We have incurred net lossessince our inception, and we had an accumulated deficit of approximately $121.7 million as of December 31, 2024. For the three monthsended March 31, 2025, and the years ended December 31, 2024, and December 31, 2023, we reported net losses of approximately $5.1 million,$22.2 million and $29.2 million, respectively. We have no products approved for commercial sale and, therefore, have never generatedany revenue from product sales, and we do not expect to do so in the foreseeable future. We have not obtained regulatory approvals forany of our product candidates, and even if our clinical development efforts result in positive data, our product candidates may not receiveregulatory approval or be successfully introduced and marketed at prices that would permit us to operate profitably. Calidi has no otherexperience as a company conducting clinical trials, submitting applications for regulatory approvals, such as a New Drug Application(“NDA”), or commercializing any products. We expect to continue to incur significant expenses and operating losses over thenext several years and for the foreseeable future. Our prior losses, combined with expected future losses, have had and will continueto have an adverse effect on our stockholders’ deficit and working capital.

Wehave incurred significant operating losses since our inception and anticipate that we will incur continued losses for the foreseeablefuture.

Substantiallyall of our operating losses have resulted from costs incurred in connection with our research and development programs and from generaland administrative costs associated with our operations. We expect our research and development expenses to significantly increase inconnection with the commencement and continuation of clinical trials of our product candidates. In addition, if we obtain marketing approvalfor our product candidates, we will incur significant sales, marketing and manufacturing expenses. Because of the Business Combination,we will incur additional costs associated with operating as a public company. As a result, we expect to continue to incur significantand increasing operating losses for the foreseeable future. Because of the numerous risks and uncertainties associated with developingbiopharmaceutical products, we are unable to predict the extent of any future losses or when we will become profitable, if at all. Evenif we do become profitable, we may not be able to sustain or increase our profitability on a quarterly or annual basis.

Theamount of our future losses is uncertain, and our quarterly operating results may fluctuate significantly or may fall below the expectationsof investors or securities analysts, each of which may cause our stock price to fluctuate or decline. Our quarterly and annual operatingresults may fluctuate significantly in the future due to a variety of factors, many of which are outside of our control and may be difficultto predict, including the following:

●the timing and success or failure of clinical trials for our product candidates or competing product candidates, or any other changein the competitive landscape of our industry, including consolidation among our competitors or partners;

●our ability to successfully enroll and retain subjects for clinical trials, and any delays caused by difficulties in such efforts;

●our ability to obtain marketing approval for our product candidates, and the timing and scope of any such approvals we may receive;

●the timing and cost of, and level of investment in, research and development activities relating to our product candidates, which maychange from time to time;

●the cost of manufacturing our product candidates, which may vary depending on the quantity of production, and the success of achievingcommercial scale manufacturing operations in our new facility or at third-party manufacturers;

●our ability to attract, hire and retain qualified personnel;

●expenditures that we will or may incur to develop additional product candidates;

●the level of demand for our product candidates should they receive approval, which may vary significantly;

●the risk/benefit profile, cost and reimbursement policies with respect to our product candidates, if approved, and existing and potentialfuture therapeutics that compete with our product candidates; and

●future accounting pronouncements or changes in our accounting policies.

Thecumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results.As a result, comparing our operating results on a period-to-period basis may not be meaningful. This variability and unpredictabilitycould also result in our failing to meet the expectations of industry or financial analysts or investors for any period. If our revenueor operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or ifthe forecasts we provide to the market are below the expectations of analysts or investors, the price of our common stock could declinesubstantially. Such a stock price decline could occur even when we have met any previously publicly stated guidance we may provide.

Wehave no products approved for commercial sale and have not generated any revenue from product sales.

Ourability to become profitable depends upon our ability to generate revenue. To date, we have not generated any revenue from our productcandidates, and we do not expect to generate any revenue from the sale of products in the near future, if any. We do not expect to generatesignificant revenue unless and until we obtain marketing approval of, and begin to sell, one or more of our product candidates. Our abilityto generate revenue depends on a number of factors, including, but not limited to, our ability to:

●successfully complete our ongoing and planned preclinical studies and clinical trials for CLD-401, the lead compound from our RedTailplatform, and for our allogeneic stem cell delivery ofoncolytic virus programs;

●timely file and receive acceptance of our Investigational New Drug applications, or INDs, in order to commence our planned clinical trialsor future clinical trials;

●successfully enroll subjects in, and complete, clinical trials for our oncolytic viral allogeneic stem cell programs;

●timely file Biologics License Applications (“BLAs”) and receive regulatory approvals for our product candidates from theFDA and other regulatory authorities;

●initiate and successfully complete all safety studies required to obtain U.S. and foreign marketing approval for our product candidates;

●establish commercial manufacturing capabilities through third-party manufacturers for clinical supply and commercial manufacturing ofour product candidates;

●obtain and maintain patent and trade secret protection or regulatory exclusivity for our product candidates;

●launch commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others;

●maintain a continued acceptable safety profile of the product candidates following approval;

●obtain and maintain acceptance of the product candidates, if and when approved, by patients, the medical community and third-party payors;

●position our products to effectively compete with other therapies;

●obtain and maintain favorable coverage and adequate reimbursement by third-party payors for our product candidates;

●enforce and defend intellectual property rights and claims with respect to our product candidates; and

●hire additional staff, including clinical, scientific and management personnel.

Ifwe do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability tosuccessfully commercialize our product candidates, which would materially harm our business. If we do not receive regulatory approvalsfor our product candidates, we may not be able to continue our operations.

Ourengineered RedTail enveloped virus platform and our allogeneic stem cell product candidates represent a novel approach to cancer treatmentthat creates significant challenges.

Weare developing an enveloped form of a proprietarily modified virus that can also deliver genetic medicines directly and exclusively totumor cells.

Weare also developing a pipeline of allogeneic stem cell product candidates engineered from healthy donor adipose-derived mesenchymal stemcells and enveloped vaccina virus to potentiate and deliver oncolytic viruses to the tumor site and are intended for use in any patientwith certain cancers. Advancing these novel product candidates creates significant challenges for us, including:

●manipulating and manufacturing our product candidates to required specifications and in a timely manner to support our clinical trials,and, if approved, commercialization;

●sourcing clinical and, if approved, commercial supplies of adipose and neuronal stem- and other cell types used to manufacture our productcandidates;

●understanding and addressing intra-donor variability in the quality and type of donor-derived stem cells, which could ultimately negativelyaffect our ability to produce a product reliably and consistently, if at all;

●understanding and addressing the sourcing of stem cells for our product candidates;

●educating medical personnel regarding the potential side effect profile of our product candidates, if approved, such as the potentialfor serious adverse events;

●using medicines to manage adverse side effects or the potential for serious adverse events of our product candidates which may not adequatelycontrol such side effects or serious adverse events, and/or may have a detrimental impact on the efficacy of treatment;

●conditioning patients with chemotherapy and possibly checkpoint inhibitors in advance of administering our product candidates, whichmay increase the risk of adverse side effects or serious adverse events;

●obtaining regulatory approval, as the FDA and other regulatory authorities have limited experience with the development and regulationof allogeneic stem cell and enveloped vaccina virus therapies for cancer; and

●establishing sales and marketing capabilities upon obtaining regulatory approval, if any, in order to gain market acceptance of a noveltherapy.

Adversepublicity regarding viral-based or genetic therapies could have a material adverse impact on our business.

Althoughwe are not utilizing embryonic stem cells, we utilize neural stem cells that have been derived from fetal tissue. Adverse publicity dueto ethical and social controversies surrounding the use of such cells or any adverse reported side effects from any stem cell, dendriticor other cell therapy clinical trial or due to the failure of such trials to demonstrate that these therapies are efficacious could materiallyand adversely affect our ability to raise capital or recruit managerial or scientific personnel or obtain research grants. In addition,in August of 2017, when we were formerly known as StemImmune, Inc., we experienced adverse publicity when the FDA incorrectly identifiedus as a Stem Cell Clinic, associated with Stem Cell Clinics that the FDA subsequently sued in federal court for alleged violations ofthe Federal Food, Drug and Cosmetics Act. While we were never named in the FDA’s litigation, our business was temporarily disruptedand our management was forced to spend time correcting the misinformation and rebuilding our reputation with the FDA and state regulatoryauthorities. Because the use of human stem cells may be controversial to some segments of society, we may experience adverse publicityagain, which may disrupt our business and distract our executive management from executing on our business plan.

Weneed to raise substantial additional funding. If we are unable to raise capital when needed, or if at all, we would be forced to delay,reduce or eliminate some or all of our product development programs or cease operations altogether.

Thedevelopment of biopharmaceutical products is capital intensive. We are currently advancing our product candidates through pre-clinicaltesting and clinical development across a number of potential indications. We have in-licensed CLD-101 for newly diagnosed high gradeglioma (“HGG”) that has completed a Phase 1 clinical trial sponsored by Northwestern University. We have opened an IND fromthe FDA to initiate a Phase 1 clinical trial for our product candidate CLD-201 that utilizes allogeneic adipose-derived mesenchymal stemcell (“AD-MSC”) line VP-001 loaded with tumor selective “CAL1” oncolytic vaccinia virus strain. Our third program,RedTail, involves significant preclinical research involving enveloping vaccinia virus within a cellular membrane that can express geneticmedicine in situ. Consequently, we expect our expenses to significantly increase in connection with our ongoing activities, particularlyas we continue our pre-clinical studies and initiate our planned clinical trials or initiate future trials on other product candidatesand pursue the research and development of, and seek marketing approval for, our product candidates. In addition, depending on the statusof regulatory approvals or, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercializationexpenses related to product sales, marketing, manufacturing and distribution. We may also need to raise additional funds sooner if wechoose to pursue additional indications and/or geographies for our product candidates or otherwise expand more rapidly than we presentlyanticipate. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate certainof our research and development programs or future commercialization efforts, and may be unable to expand our operations or otherwisecapitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results ofoperations.

Ourfuture capital requirements will depend on and could increase significantly as a result of many factors, including:

●the scope, progress, results and costs of product discovery, preclinical and clinical development, laboratory testing and clinical trialsfor the development of CLD-401 (our lead compound from the RedTail platform), CLD-101 for recurrent HGG, or our other potential productcandidates;

●the timing of, and the costs involved in, obtaining marketing approvals for any of our initial target indications and our other potentialproduct candidates that we may develop;

●if approved, the costs of commercialization activities for any of our product candidates that receives regulatory approval to the extentsuch costs are not the responsibility of a collaborator that we may contract with in the future, including the costs and timing of establishingproduct sales, marketing, distribution and manufacturing capabilities;

●the scope, prioritization and number of our research and development programs;

●the costs, timing and outcome of regulatory review of our product candidates;

●our ability to establish and maintain additional collaborations on favorable terms, if at all;

●the achievement of milestones or occurrence of other developments that trigger payments under any additional collaboration agreementswe may enter into;

●the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under future collaboration agreements,if any;

●the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defendingintellectual property-related claims;

●the extent to which we acquire or in-license other product candidates and technologies;

●the costs of securing manufacturing arrangements for commercial production;

●the emergence of competing oncolytic viral immunotherapies as well as immuno-oncology therapies in general and other adverse market developments;

●the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory approvals to market our productcandidates; and

Identifyingpotential product candidates and conducting preclinical development testing and clinical trials is a time-consuming, expensive and uncertainprocess that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval andachieve product sales. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenues,if any, will be derived from sales of products that we do not expect to be commercially available for many years, if at all. Accordingly,we will need to continue to rely on additional financing to achieve our business objectives.

Anyadditional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability todevelop and commercialize our product candidates. Disruptions in the financial markets in general have made equity and debt financingmore difficult to obtain, and may have a material adverse effect on our ability to meet our fundraising needs. We cannot guarantee thatfuture financing will be available in sufficient amounts or on terms acceptable to us, if at all. Moreover, the terms of any financing,including a potential private investment in public equity, if any, may adversely affect the holdings or the rights of our stockholdersand the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market priceof our shares to decline. The sale of additional equity or convertible securities would dilute all of our stockholders. The incurrenceof indebtedness would result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants,such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual propertyrights and other operating restrictions that could adversely impact our ability to conduct our business. We could also be required toseek funds through arrangements with collaborators or otherwise at an earlier stage than otherwise would be desirable and we may be requiredto relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us, any of which mayhave a material adverse effect on our business, operating results and prospects.

Ifwe are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or all of ourresearch or development programs or the commercialization of any product candidate or be unable to expand or continue our operationsor otherwise capitalize on our business opportunities, as desired, which could materially affect our business, financial condition andresults of operations.

RisksRelated to Product Development

Ourbusiness is highly dependent on the success of our RedTail platform and our SuperNova and NeuroNova compounds. If we are unable to anyof our compounds effectively commercialize any of these product candidates for the treatment of patients in its approved indications,our business would be significantly harmed.

Ourbusiness and future success depend on our ability to obtain regulatory approval of, and then successfully commercialize, our productcandidates. The preclinical and clinical results to date may not predict outcomes for our planned trial or any future studies.

Ourproduct candidates will require additional clinical and non-clinical development, regulatory review and approval in multiple jurisdictions,a substantial investment, access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generateany revenue from product sales.

Ourpreclinical studies and clinical trials may fail to demonstrate adequately the safety and efficacy of any of our product candidates,which would prevent or delay development, regulatory approval, and commercialization.

Beforeobtaining regulatory approvals for the commercial sale of our product candidates,we must demonstrate the safety and efficacy of our productcandidates for use in each target indication through lengthy, complex, and expensive preclinical studies and clinical trials. Failurecan occur at any time during the preclinical study and clinical trial processes and there is a high risk of failure, so we may neversucceed in developing marketable products. Any preclinical studies or clinical trials that we may conduct may not demonstrate the safetyand efficacy necessary to obtain regulatory approval to market any of our product candidates. If the results of our ongoing or futurepreclinical studies and clinical trials are inconclusive with respect to the safety and efficacy of our product candidates, if we donot meet the clinical endpoints with statistical and clinically meaningful significance, or if there are safety concerns associated withour product candidates, we may be prevented or delayed in obtaining marketing approval for such product candidates. In some instances,there can be significant variability in safety or efficacy results between different preclinical studies and clinical trials of the sameproduct candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size andtype of the patient populations, changes in and adherence to the clinical trial protocols and the rate of dropout among clinical trialparticipants. While we are currently in early stages of clinical development for CLD-101 for recurrent HGG, CLD-201, and the RedTailplatform, it is likely, as is the case with many oncology therapies, that there may be side effects associated with their use.

Resultsof our trials could reveal a high and unacceptable severity and prevalence of side effects. In such an event, our trials could be suspendedor terminated, and the FDA or other regulatory authorities could order us to cease further development of or deny approval of our productcandidates for any or all targeted indications. Treatment-related side effects could also affect patient recruitment or the ability ofenrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may harm our business,financial condition and prospects significantly.

Interim,top line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient databecome available and are subject to regulatory audit and verification procedures that could result in material changes in the final data.

Fromtime to time, we may publish interim, top line or preliminary data from our clinical trials. We may decide to conduct an interim analysisof the data after a certain number or percentage of patients have been enrolled, or after only a part of the full follow-up period butbefore completion of the trial. Similarly, we may report top line or preliminary results of primary and key secondary endpoints beforethe final trial results are completed. Preliminary, top line and interim data from our clinical trials may change as more patient dataor analyses become available. Preliminary, top line or interim data from our clinical trials are not necessarily predictive of finalresults and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues,more patient data become available and we issue our final clinical trial report. These data also remain subject to audit and verificationprocedures that may result in the final data being materially different from the preliminary data we previously published. As a result,preliminary, interim and top line data should be viewed with caution until the final data are available. Material adverse changes inthe final data compared to the interim data could significantly harm our business prospects.

Further,others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analysesor may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvabilityor commercialization of the particular product candidate or product and our company in general. In addition, the information we chooseto publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or othersmay not agree with what we determine is material or otherwise appropriate information to include in our disclosure.

Ifthe interim, topline, or preliminary data that we report differ from more complete results, or if others, including regulatory authorities,disagree with the conclusions reached, our ability to obtain marketing authorization for, and commercialize, our product candidates maybe harmed, which could harm our business, operating results, prospects or financial condition.

Resultsof earlier studies and trials of our product candidates may not be predictive of future trial results.

Successin preclinical studies and early clinical trials does not ensure that later clinical trials will be successful. Product candidates inlater stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinicalstudies and initial clinical trials. As we commence new clinical trials and continue our ongoing clinical trials, issues may arise thatcould suspend or terminate such clinical trials. A number of companies in the biotechnology and pharmaceutical industries have sufferedsignificant setbacks in clinical trials, even after positive results in earlier preclinical studies or clinical trials. These setbackshave been caused by, among other things, preclinical findings made while clinical trials were underway and safety or efficacy observationsmade in clinical trials, including previously unreported adverse events. Notwithstanding any potential promising results in earlier studiesand trials, we cannot be certain that we will not face similar setbacks. In addition, the results of our preclinical animal studies,including our oncology mouse studies and animal studies, may not be predictive of the results of outcomes in human clinical trials. Forexample, our oncology product candidates that are in preclinical development may demonstrate different chemical and biological propertiesin patients than they do in laboratory animal studies or may interact with human biological systems in unforeseen or harmful ways.