Candel Therapeutics Inc 2025年季度报告

(Mark One)☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF1934 For the quarterly period endedMarch 31,2025OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF1934For the transition period from ______________ to ______________Commission File Number:001-40629 CANDEL THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Registrant’s telephone number, including area code: (617)916-5445 Securities registered pursuant to Section 12(b) of the Act: Title of each classTradingSymbol(s)Name of each exchange on which registeredCommon Stock, par value $0.01 per shareCADLThe Nasdaq Global Market Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of theSecurities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to filesuch 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 besubmitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorterperiod 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, asmaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Accelerated filer☐Smaller reporting company☒Emerging growth company☒ Large accelerated filer☐Non-accelerated filer☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition periodfor complying 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 Exchange Act).Yes☐No☒ As of May 5, 2025, the registrant had50,102,679shares of common stock, $0.01 par value per share, outstanding. SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q (Form 10-Q), including the section entitled “Management’s Discussion and Analysis ofFinancial Condition and Results of Operations,” contains express or implied forward-looking statements that are based on ourmanagement’s belief and assumptions and on information currently available to our management. Although we believe thatthe expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or ourfuture operational or financial performance, and involve known and unknown risks, uncertainties, and other factors that maycause our actual results, performance, or achievements to be materially different from any future results, performance, orachievements expressed or implied by these forward-looking statements. Forward-looking statements in this Form 10-Q mayinclude, but are not limited to, statements about: •the timing and the success of preclinical studies and clinical trials of CAN-2409 (international non-proprietaryname: aglatimagene besadenovec) and CAN-3110 and any other product candidates;•the initiation of any clinical trials of CAN-2409 and CAN-3110 and any other product candidates;•our need to raise additional funding before we can expect to generate any revenues from product sales;•our ability to conduct successful clinical trials or obtain regulatory approval for CAN-2409 and CAN-3110 or anyother product candidates that we may identify or develop;•the ability of our research to generate and advance additional product candidates;•the effects of public health crises, outbreaks of an infectious disease or ongoing geopolitical conflicts, includingmitigation efforts and economic effects, on any of the foregoing or other aspects of our business operations;•our ability to establish an adequate safety or efficacy profile for CAN-2409, CAN-3110 or any other productcandidates that we may pursue;•our ability to manufacture CAN-2409, CAN-3110 or any other product candidate in conformity with ourspecifications and the U.S. Food and Drug Administration’s (FDA) requirements and to scale up manufacturing ofour product candidates to commercial scale, if approved;•the implementation of our strategic plans for our business, any product candidates we may develop and anycompanion diagnostics;•our intellectual property position, including the scope of protection we are able to establish and maintain forintellectual property rights covering our product candidates any companion diagnostics;•the rate and degree of market acceptance and clinical utility for any product candidates we may develop;•estimates of our expenses, future re