安克赛斯生物科学公司 2025年季度报告

FORM10-Q ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period endedApril 30,2025 or ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ ANIXA BIOSCIENCES, INC. 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 to Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submitsuch files). Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, oran emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging Large accelerated filer☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐No☒ Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date. On May 28, 2025, the registrant had outstanding32,211,092shares of Common Stock, par value $.01per share, which is the registrant’s only classof common stock. TABLE OF CONTENTS PART I. FINANCIAL INFORMATION ANIXA BIOSCIENCES, INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)(in thousands, except share and per share data) ANIXA BIOSCIENCES, INC. AND SUBSIDIARIESNOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS(UNAUDITED) 1.BUSINESS AND FUNDING Description of Business As used herein, “we,” “us,” “our,” the “Company” or “Anixa” means Anixa Biosciences, Inc. and its consolidated subsidiaries. Anixa Biosciences, Inc. is a biotechnology company developing therapies and vaccines that are focused on critical unmet needs inoncology. Our therapeutics program consists of the development of a chimeric endocrine receptor-T cell therapy, a novel form of chimeric antigenreceptor-T cell (“CAR-T”) technology, initially focused on treating ovarian cancer, which is being developed at our subsidiary, CertaintyTherapeutics, Inc. (“Certainty”). Our vaccine programs include (i) the development of a vaccine against breast cancer, initially focused on triplenegative breast cancer (“TNBC”), the most lethal form of breast cancer, (ii) the development of a vaccine against ovarian cancer, and (iii) a vaccine Our subsidiary, Certainty, is developing immuno-therapy drugs against cancer. Certainty holds an exclusive worldwide, royalty-bearinglicense to use certain intellectual property owned or controlled by The Wistar Institute (“Wistar”), the nation’s first independent biomedical researchinstitute and a leading National Cancer Institute (“NCI”) designated cancer research center, relating to Wistar’s chimeric endocrine receptor targetedtherapy technology. We have initially focused on the development of a treatment for ovarian cancer, but we also may pursue applications of thetechnology for the development of treatments for additional solid tumors. The license agreement requires Certainty to make certain cash and equitypayments to Wistar upon achievement of specific development milestones. With respect to Certainty’s equity obligations to Wistar, Certainty issued Certainty, in collaboration with the H. Lee Moffitt Cancer Center and Research Institute, Inc. (“Moffitt”), has begun human clinical testingof the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer. After receiving authorization from the FDA,we commenced enrollment of patients in a Phase 1 clinical trial and treated the first patient in August 2022. Further, in May 2023 and August 2023,we treated the second and third patients in the trial, respectively, at the same dose level as the first patient, and the treatment was well-tolerated bythe patients. In February 2024, May 2024 and June 2024, we treated the three patients, respectively, of the second dose cohort, where the patientswere administered a three-times higher dose of cells than the patients in the first cohort. The treatment at this dose level has also been well-toleratedby the patients. While the dose levels in the first two cohorts were expected to be sub-therapeutic, two of the six patients exhibited some anecdotalsigns of efficacy. Both have shown possible si