Kalaris Therapeutics Inc 2025年度报告

2025 ANNUAL REPORT 400 Connell Drive, Suite 5500Berkeley Heights, New Jersey 07922(650) 249-2727 Dear Kalaris Therapeutics, Inc. Stockholders: 2025 was a transformational year for our company, and I want to thank each employee,stockholder, and external vendor partner for their contributions to and support of our mission todevelop and commercialize treatments for prevalent retinal diseases with major unmet medicalneeds. Our lead product candidate, TH103, is a novel investigational therapy engineered byVEGF scientific pioneer Dr. Napoleone Ferrara to address the limitations of current therapies forneovascular and exudative retinal diseases. I also would like to recognize each patient who hasenrolled in our clinical trial of TH103 for nAMD, as well as the clinical trial’s principalinvestigators and their teams. Our merger with AlloVir Inc., which closed in March 2025, has further strengthened ourfoundation and enabled us to continue to advance the clinical development of TH103. In the thirdquarter of 2025, we began to enroll patients in our Phase 1b/2 multiple ascending dose trial ofTH103 in nAMD, which is designed to inform dose selection for potential Phase 3 development.We also opened our new corporate headquarters in Berkeley Heights, New Jersey and selectedKBI Biopharma as our Contract Development and Manufacturing Organization for clinical andcommercial drug substance manufacturing. The year culminated with our announcement of positive initial Phase 1a single ascending dosedata for TH103 in December 2025. These data indicated that TH103 was generally well toleratedand exhibited improvements on visual acuity and retinal anatomy outcomes at 1-month post-dosing. In addition, preliminary single dose pharmacokinetic data suggested increasedintraocular retention, which may support a longer duration of effect. Also in December 2025, weraised gross proceeds of $50.0 million through an oversubscribed private placement of equitysecurities, which helped strengthen our balance sheet. As we advance the development of TH103, we remain committed to our belief that TH103 mayprovide extended intraocular retention with enhanced VEGF inhibition and has potential to be abest-in class therapeutic for patients with neovascular and exudative retinal diseases. These areexciting times for Kalaris, and on behalf of myself, our Board of Directors, management and theentire Kalaris team, I want to thank you for your continued support. Andrew OxtobyPresident and Chief Executive Officer UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, DC 20549FORM 10-K (Mark One)շANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025ORնTRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934FOR THE TRANSITION PERIOD FROM _________________ TO _________________Commission File Number: 001-39409 KALARIS THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) 83-1971007(I.R.S. EmployerIdentification No.) Delaware(State or other jurisdiction ofincorporation or organization)400 Connell Drive, Suite 5500Berkeley Heights, New Jersey(Address of principal executive offices) Registrant’s telephone number, including area code: (650) 249-2727 Securities registered pursuant to Section 12(b) of the Act: Securities registered pursuant to Section 12(g) of the Act:None Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.YesնNoշ Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act.YesնNoշ 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 1934 duringthe 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 requirements for thepast 90 days.YesշNoն 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).YesշNoն Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or anemerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule12b-2 of the Exchange Act. Accelerated filerնSmaller reporting companyշEmerging growth companyն 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 orrevised financial accounting standards provided pursuant to Section 13(a) of the Exchange Ac