Monopar Therapeutics Inc 2025年季度报告

FORM10-Q (Mark One) ☒Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 MONOPAR THERAPEUTICS INC. (Exact name of registrant as specified in its charter) 32-0463781(I.R.S. employeridentification number) (847)388-0349(Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the SecuritiesExchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submittedpursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that 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 the definitions of “large accelerated filer,” “accelerated filer,” “smaller 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 period forcomplying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes☐No☒ The number of shares outstanding with respect to each of the classes of our common stock, as of April30, 2025, is set forth below: MONOPAR THERAPEUTICS INC.TABLE OF CONTENTS Part IFINANCIAL INFORMATION Item 1.Financial Statements (Unaudited)7Condensed Consolidated Balance Sheets as of March 31, 2025, and December 31, 20247Condensed Consolidated Statements of Operations and Comprehensive Loss for the ThreeMonths EndedMarch 31, 2025 and 20248Condensed Consolidated Statements of Stockholders’Equity for the ThreeMonths Ended March 31, 2025and 20249Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2025 and 202411Notes to Condensed Consolidated Financial Statements12Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations24Item 4.Controls and Procedures33Part IIOTHER INFORMATION33Item 1A.Risk Factors33Item 5.Other Information33Item 6.Exhibits34Signatures352 Forward-Looking Statements This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the SecuritiesAct of 1933, as amended (the “Act”), and Section 21E of the Securities Exchange Act of 1934, as amended. All statements otherthan statements of historical facts included in this Quarterly Report on Form 10-Q are forward-looking statements. The words“hopes,” “believes,” “anticipates,” “plans,” “seeks,” “estimates,” “projects,” “expects,” “intends,” “may,” “could,” “should,” ●ourability to raise sufficient funds in order for us to support continued clinical, regulatory and commercialdevelopment of our programs and to make contractualfuture milestone payments, as well as our ability to furtherraise additional funds in the future to support any existing or future productcandidate programs through completion ●our ability to raise funds on acceptable terms; ●our ability to find a suitable pharmaceutical partner or partners to further our development efforts, under acceptablefinancial terms; ●risks and uncertainties associated with our or any development partners’research and development activities,including preclinical studies, clinical trials, regulatory submissions, and manufacturing and quality expenses; ●knownand unknown risks associated with developing copper-chelating therapies and radiopharmaceuticaltherapeutics and imaging agents; ●the uncertainty of timeframes for our clinical trials and regulatory reviews for approval to market products; ●uncertainties related to the regulatory discussions we may initiate related to ALXN1840 and the outcome(s) thereof; ●potential delays and/or additional significant expenses related to developing and filing a New Drug Application(“NDA”) for ALXN1840; ●our ability to address the fulfillment and logistical challenges posed by the potential time-limited shelf-life of ourcurrent radiopharmaceutical programs or future drug candidates; ●our ability to obtain an adequate supply at reasonable costs of radioisotopes that we are currently using or that wemay incorporate in the future into our drug candidates; ●market uptake and competitiveness in terms of pricing, efficacy and safety, of any products for which we receivemarketing approval,