标志点制药 2025年季度报告

FORM10-Q(Mark one) ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF1934 For the quarterly period endedMarch 31, 2025 OR For the transition period from _________to_________ Commission File Number001-38128 CHECKPOINT THERAPEUTICS,INC.(Exact name of registrant as specified in its charter) Delaware47-2568632(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.) (Address of principal executive offices and zip code) (781)652-4500(Registrant’s telephone number, including area code) Securities registered pursuant to Section12(b)of the Act: Indicate by check mark whether the registrant (1)has filed all reports required to be filed by Section13 or 15(d)of theSecurities Exchange Act of 1934 during the preceding 12months (or for such shorter period that the registrant was required tofile such reports), and (2)has been subject to such filing requirements for the past 90days.YES☒NO☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to besubmitted pursuant to Rule405 of Regulation S-T (§232.405 of this chapter) during the preceding 12months (or for suchshorter period that the registrant was required to submit such files).YES☒NO☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smallerreporting company, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” “smallerreporting company” and “emerging growth company” in Rule12b-2 of the Exchange Act. Large Accelerated Filer☐Accelerated Filer☐Non-accelerated Filer☒Smaller Reporting Company☒Emerging growth company☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition periodfor complying with any new or revised financial accounting standards provided pursuant to Section13(a)of the ExchangeAct.☐ Indicate by check mark whether registrant is a shell company (as defined in Rule12b-2 of the Exchange Act). YES☐NO☒ Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date. CHECKPOINT THERAPEUTICS, INC.Form 10-QFor the Quarter Ended March 31, 2025 Table of Contents Page No.PART I. FINANCIAL INFORMATIONItem 1.Financial Statements3Condensed Balance Sheets as of March 31, 2025 and December 31, 20243Condensed Statements of Operations for the three months ended March 31, 2025 and 20244Condensed Statements of Stockholders’ Equity (Deficit) for the three months ended March 31,2025 and 20245Condensed Statements of Cash Flows for the three months ended March 31, 2025 and 20246Notes to Condensed Financial Statements7Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations24Item 3.Quantitative and Qualitative Disclosures About Market Risk28Item 4.Controls and Procedures28PART II. OTHER INFORMATIONItem 1.Legal Proceedings29Item1A.Risk Factors29Item 2.Unregistered Sales of Equity Securities and Use of Proceeds60Item 3.Defaults Upon Senior Securities60Item 4.Mine Safety Disclosures60Item 5.Other Information60Item 6.Exhibits61Signatures62 SUMMARY OF RISK FACTORS Our business is subject to risks of which you should be aware before making an investment decision. The risksdescribed below are a summary of the principal risks associated with an investment in us and are not the onlyrisks we face. You should carefully consider these risk factors, the risk factors described in Item 1A, and the otherreports and documents that we have filed with the Securities and Exchange Commission (“SEC”). RisksRelated to Drug Development,and the Commercialization of our FDA Approved ProductUNLOXCYT™ ●Because results of preclinical studies and clinical trials are not necessarily predictive of future results,any product or product candidate we advance may not have favorable results in later clinical trials.Moreover, interim, “top-line,” and preliminary data from our clinical trials that we announce or publishmay change, or the perceived product profile may be impacted, as more patient data or additionalendpoints are analyzed.●Besides UNLOXCYT, we may not receive the required regulatory approvals for any of our productcandidates on our projected timelines, if at all, which may result in increased costs and delay our abilityto generate revenue.●If UNLOXCYT, a product or product candidate demonstrates lack of efficacy or adverse side effects, wemay need to abandon or limit the development or commercialization of such product candidate.●We may not obtain the desired labeling claims or intended uses for product or UNLOXCYT promotion,or favorable scheduling classifications, to successfully promote our products or UNLOXCYT.●Even if a product candidate is approved, such as UNLOXCYT, it may be subject to various post-marketing requirements, including studies or clinical trials, and increa