Regulus Therapeutics Inc 2025年度季度报告

Indicate by check mark whether the registrant (1)has filed all reports required to be filed by Section13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 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 90days.Yes x No¨ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation 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 x No¨ Indicate by check mark whether registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growthcompany. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of theExchange Act. Largeacceleratedfiler☐ 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 revised☐ Indicate by check mark whether registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).Yes☐No☒As of May2, 2025, the registrant had69,234,089shares of Common Stock ($0.001 par value) outstanding. REGULUS THERAPEUTICS INC.TABLE OF CONTENTS PART I. FINANCIAL INFORMATION Item1. Financial Statements 3Condensed Balance Sheets as of March 31, 2025 (Unaudited) and December 31, 20243Condensed Statements of Operations and Comprehensive Loss for the three months ended March 31,2025 and 2024 (Unaudited)5Condensed Statements of Changes in Stockholders' Equity for the three months ended March 31, 2025and 2024 (Unaudited)6Condensed Statements of Cash Flows for the three months ended March 31, 2025 and 2024(Unaudited)8Notes to Condensed Financial Statements (Unaudited)9Item2. Management’s Discussion and Analysis of Financial Condition and Results of Operations20Item3. Quantitative and Qualitative Disclosures about Market Risk27Item4. Controls and Procedures27 PART II. OTHER INFORMATION Item1. Legal ProceedingsItem1A. Risk FactorsItem2. Unregistered Sales of Equity Securities and Use of ProceedsItem3. Defaults Upon Senior SecuritiesItem4. Mine Safety DisclosuresItem5. Other InformationItem6. Exhibits RISK FACTOR SUMMARY Below is a summary of the material factors that make an investment in our common stock speculative or risky. This summarydoes not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risksthat we face, can be found below under the heading “Risk Factors” under Part II, Item 1A of this Quarterly Report and should be •We may not complete the pending transaction with Novartis AG ("Novartis" or the "Parent") within the timeframe weanticipate, or at all, which could have an adverse effect on our business, financial results, and/or operations. •We will need to raise additional capital to develop our product candidates and implement our operating plans, and if we areunable to do so when needed, we will not be able to complete the development and commercialization of our productcandidates. •We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the •The approach we are taking to discover and develop drugs is novel and may never lead to marketable products. •We may not besuccessful in our efforts to identify or discover potential product candidates. Preclinical and clinical studies of our product candidates may not be successful. Success in preclinical studies may not beindicative of the results that may occur in clinical trials for our product candidates. If we are unable to generate successful •If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities ordo not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be •Any of our product candidates may cause adverse effects or have other properties that could delay or prevent their regulatoryapproval or limit the scope of any approved label or market acceptance. Even if we complete the necessary preclinical studies and clinical trials, we cannot predict whether or when we will obtainregulatory approval to commercialize a product candidate and we cannot, therefore, predict the timing of any revenue from a •We have never generated any revenue from product sales and may never be profitable. •We will depend upon collaborations for the development and eventual commercialization of certainmicroRNA productcandidates. If these collaborations are unsuccessful or are terminated, we may be unable to commercialize certain product We rely on limited sources of supply for the drug substance of p