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Definium Therapeutics Inc 2026年季度报告

2026-05-07 美股财报 严宏志19905053625
报告封面

☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period fromtoCommission File Number 001-40360 Definium Therapeutics, Inc.(Exact name of Registrant as specified in its Charter) 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 of1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject tosuch 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 submitted pursuant to Rule405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required tosubmit 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 an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerginggrowth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer☐Non-accelerated filer☒Emerging growth company☒ Accelerated filer☐ Smaller reporting company☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying withany 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 Exchange Act).Yes☐No☒As of April 30, 2026 the registrant had 109,066,783 Common Shares outstanding. Table of Contents PART IFINANCIAL INFORMATIONItem 1.Financial StatementsCondensed Consolidated Balance SheetsCondensed Consolidated Statements of Operations and Comprehensive LossCondensed Consolidated Statements of Shareholders' EquityCondensed Consolidated Statements of Cash FlowsNotes to Condensed Consolidated Financial StatementsItem 2.Management’s Discussion and Analysis of Financial Condition and Results of OperationsItem 3.Quantitative and Qualitative Disclosures About Market RiskItem 4.Controls and Procedures PART IIOTHER INFORMATION Item 1.Legal ProceedingsItem 1A.Risk FactorsItem 2.Unregistered Sales of Equity Securities and Use of ProceedsItem 3.Defaults Upon Senior SecuritiesItem 4.Mine Safety DisclosuresItem 5.Other InformationItem 6.ExhibitsSignatures SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q ("Quarterly Report") contains forward-looking statements about us and our industry thatinvolve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report,including statements regarding our future results of operations or financial condition, business strategy and plans and objectives ofmanagement for future operations, are forward-looking statements. In some cases, you can identify forward-looking statementsbecause they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,”“may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will” or “would” or the negative of these words or other similarterms or expressions. These forward-looking statements include, but are not limited to, statements concerning the following: •the timing, progress and results of our investigational programs for DT120 (previously referred to as MM120), aproprietary, pharmaceutically optimized form of lysergide D-tartrate (LSD), DT402 (previously referred to as MM402),also referred to as R(-)-MDMA (together, our “lead product candidates”) and any other product candidates (togetherwith our lead product candidates, our “product candidates”);•our reliance on the success of our investigational DT120 product candidate;•our expectations regarding our cash runway;•the protocols and timing of availability of data from our ongoing Phase 3 clinical program for DT120 orallydisintegrating tablet (“ODT”) in generalized anxiety disorder (“GAD”);•the protocols and timing of availability of data from our ongoing Phase 3 clinical program for DT120 ODT in majordepressive disorder (“MDD”);•the timing of initiation of our Phase 3 clinical trial of DT120 ODT in posttraumatic stress disorder (“PTSD”), and theprotocol for our proposed Phase clinical trial of DT120 ODT in PTSD;•the timing, scope or likelihood of regulatory filings and approvals and our ability to obtain and maintain regulatoryapprovals for product candidates for any indication;•our expectations regarding the size of the eligible patient populations for our lead product candidates, if approved andcommercialized;•our ability to identify third-party treatment