Viridian Therapeutics Inc 2025年季度报告

FORM10-Q (Mark One) ☒QUARTERLY REPORT PURSUANT TO SECTION13 OR 15(d) OF THE SECURITIESEXCHANGE ACT OF 1934 For the quarterly period endedMarch31, 2025or ☐TRANSITION REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIESEXCHANGE ACT OF1934 For the transition period fromtoCommission File No.001-36483 VIRIDIAN THERAPEUTICS, INC. 02453(Zip Code) (617)272-4600(Registrant’s telephone number, including area code) (Former name, former address and former fiscal year, if changed since last report):N/ASecurities 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 the SecuritiesExchange Act of 1934 during the preceding 12months (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 90days.Yes☒Noo Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submittedpursuant to Rule405 of RegulationS-T (§232.405 of this chapter) during the preceding 12months (or for such shorter period that theregistrant was required to submit such files).Yes☒Noo 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,” “smallerreporting company,” and “emerging growth company” in Rule 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 forcomplying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.o Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Exchange Act).Yes☐No☒ As of May1, 2025, there were81,592,026shares of the registrant’s common stock outstanding. VIRIDIAN THERAPEUTICS, INC.INDEX PART I. FINANCIAL INFORMATIONItem1. Financial Statements6Item2. Management’s Discussion and Analysis of Financial Condition and Results of Operations33Item3. Quantitative and Qualitative Disclosures about Market Risk42Item4. Controls and Procedures42 Item1. Legal Proceedings43Item1A. Risk Factors43Item2. Unregistered Sales of Equity Securities and Use of Proceeds82Item3. Defaults Upon Senior Securities82Item4. Mine Safety Disclosures82Item5. Other Information82Item6. Exhibits83 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q (“Quarterly Report”) contains forward-looking statements that involve risks and uncertainties.We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of1995 and other federal securities laws. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,”“intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions mayidentify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forwardlooking statements contained in this Quarterly Report include, but are not limited to, statements about: •the ability of our clinical trials to demonstrate safety and efficacy of our product candidates and other results; •the potential utility, efficacy, potency, safety, clinical benefits, half-life, clinical response, convenience and number ofindications of our product candidates, including our expectation that VRDN-003 will demonstrate a similar clinical responseas veligrotug; •the timing and focus of our ongoing and future nonclinical studies and clinical trials and the timing of reporting data fromthose studies and trials, including that we expect to receive VRDN-006 proof of concept immunoglobulin G (“IgG”)reduction data in the third quarter of 2025, that we anticipate submitting an Investigational New Drug Application (“IND”)for VRDN-008 by the end of 2025, and that we plan to initiate an auto-injector study of VRDN-003 in 2025; •supply chain disruptions, enrollment in clinical trials involving our product candidates or other delays in such trials; •our plans relating to commercializing our product candidates, including our plans to commercialize products candidates ascombination products, if approved, including the geographic areas of focus and sales strategy; •potential market sizes and market opportunities, including the rate and degree of market acceptance and clinical utility for ourproduct candidates; •expectations regarding the initiation of clinical trials and interactions and alignment with regulatory authorities; •the timing or likelihood of regulatory filings and approvals, including the anticipated biologics license application (“BLA”)submission for veligrotug in the second half of 20