美第奇新星生物技术 2026年季度报告

Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934during 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 requirementsfor the past 90 days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 ofRegulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter 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 smaller reporting company or anemerging growth company. See the definitions of “accelerated filer”, “large accelerated filer”, “smaller reporting company” and “emerging growth company” inRule 12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial 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 Exchange Act).Yes☐No☒ As of August 11, 2026, the registrant had 49,221,246 shares of Common Stock ($0.001 par value) outstanding. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q, in particular "Item 2. Management's Discussion and Analysis of Financial Conditionand Results of Operations," and the information incorporated by reference herein contains “forward-looking statements”. Theforward-looking statements are contained principally in the sections titled “Risk Factors” and “Management’s Discussion andAnalysis of Financial Condition and Results of Operations,” but are also contained elsewhere in this report. Forward-lookingstatements include all statements that are not historical facts and, in some cases, can be identified by terms such as "believe,""may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek,""should," "would" or the negative version of these words and similar expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actualresults, performance or achievements to be materially different from any future results, performance or achievements expressed orimplied by the forward-looking statements, including those described in "Risk Factors" and elsewhere in this report. Given theseuncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements representour beliefs and assumptions only as of the date of this report. Considering the significant uncertainties in these forward-lookingstatements, you should not regard these statements as a representation or warranty by us or any other person that we will achieveour objectives and plans in any specified time frame, or at all. You should read this report completely and with the understandingthat our actual future results may be materially different from what we expect. The following factors are among those that may cause actual results to differ materially from our forward-looking statements: •Inability to raise additional capital if needed;•Inability to generate revenues from product sales to continue business operations;•Inability to develop and commercialize our product candidates;•Failure or delay in completing clinical trials or obtaining Food and Drug Administration or foreign regulatory approvalfor our product candidates in a timely manner;•Unsuccessful clinical trials stemming from clinical trial designs, failure to enroll a sufficient number of patients,undesirable side effects and other safety concerns;•Inability to demonstrate sufficient efficacy of product candidates;•Reliance on the success of our MN-166 (ibudilast) and MN-001 (tipelukast) product candidates;•Delays in commencement or completion of clinical trials or suspension or termination of clinical trials;•Loss of our licensed rights to develop and commercialize a product candidate as a result of the termination of theunderlying licensing agreement;•Competitors may develop products rendering our product candidates obsolete and noncompetitive;•Inability to successfully attract partners and enter into collaborations on acceptable terms;•Dependence on third parties to conduct clinical trials and to manufacture product candidates;•Dependence on third parties to market and distribute products;•Our product candidates, if approved, may not gain market acceptance or obtain adequate coverage for third partyreimbursement;•Disputes or other developments concerning