Anixa Biosciences Inc

Anixa Biosciences, Inc. is a biotechnology company developing therapies and vaccines focused on critical unmet needs in oncology. The company's therapeutics program consists of the development of liraltagene autoleucel (lira-cel), a chimeric endocrine receptor-T cell therapy, which is a novel form of chimeric antigen receptor-T cell (CAR-T) technology, initially focused on treating ovarian cancer, that is being developed at its subsidiary, Certainty Therapeutics, Inc. The vaccine programs include the development of a vaccine against breast cancer, the development of a vaccine against ovarian cancer, and a vaccine discovery program utilizing the same mechanism to develop additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung, colon and prostate. According to American Cancer Society statistics cited in the filing, in the U.S., ovarian cancer accounts for just 2% of all female cancer cases, but over 4% of cancer deaths in women, with an estimated 21,000 new cases and approximately 13,000 deaths in 2025. Breast cancer accounts for over 30% of all female cancer cases and nearly 15% of cancer deaths in women, with an estimated 317,000 new cases and approximately 42,000 deaths in 2025. Lung cancer accounts for 11% of all cancer cases and 20% of cancer deaths, with an estimated 227,000 new cases and approximately 125,000 deaths in 2025. Colon cancer accounts for 8% of all cancer cases and 9% of cancer deaths, with an estimated 154,000 new cases and approximately 53,000 deaths in 2025. Prostate cancer accounts for nearly 30% of all male cancer cases and 11% of cancer deaths in men, with an estimated 314,000 new cases and approximately 36,000 deaths in 2025.

Management states that based on currently available information as of January 12, 2026, they believe existing cash, cash equivalents and short-term investments will be sufficient to fund activities for at least the next twelve months. The company expects to continue incurring material research and development and general and administrative expenses and anticipates incurring losses in the future. Management does not expect to begin generating revenue with respect to any of the current therapy or vaccine programs in the near term.

A primary growth vector is the advancement of the breast cancer vaccine program. In June 2025, enrollment was completed in the Phase 1 trial, and in October 2025, all patient clinical visits were completed. On December 11, 2025, final data from the Phase 1 clinical trial was presented at the San Antonio Breast Cancer Symposium, with key results including that all primary study endpoints were met, protocol defined immune responses were observed in 74% of the study subjects, and the vaccine was safe and well-tolerated at the maximum tolerated dose. The company is preparing to initiate a Phase 2 clinical trial in the neo-adjuvant setting (pre-surgery) to determine possible therapeutic effect of the vaccine, which will commence following FDA consultations, protocol development, manufacturing and clinical site selection. Consenting participants will be followed for five years after completing the study.

Another growth vector is the CAR-T therapeutic program, lira-cel, being developed at subsidiary Certainty in collaboration with Moffitt. The Phase 1 clinical trial is a dose-escalation trial with two arms based on route of delivery (intraperitoneal or intravenous) to determine the maximum tolerated dose in patients with recurrent epithelial ovarian cancer. The study will consist of up to 24 to 48 patients who have received at least two prior lines of chemotherapy and is estimated to be completed in two to three years. Patients in the fourth dose cohort were administered a 30-times higher dose of cells than patients in the first dose cohort, and the treatment appears to have been well-tolerated. Multiple patients have exhibited anecdotal signs of efficacy, including one patient that survived over two years past initial treatment and three other patients that survived over one year past treatment.

The ovarian cancer vaccine program is being advanced through the NCI's PREVENT program, which was granted acceptance in May 2021. The scientific and financial resources of the PREVENT program are being used to perform virtually all pre-clinical research and development, manufacturing and IND enabling studies at NCI facilities, by NCI scientific staff and with NCI financial resources, requiring no material financial expenditures by the Company. The vaccine discovery program, initiated through a Joint Development and Option Agreement with Cleveland Clinic in May 2024, is focused on discovering additional retired proteins associated with high incidence malignancies in the lung, colon and prostate, and is in its early stages.

The filing does not provide specific margin trajectory, cost structure evolution, or efficiency targets with exact figures. Research and development expenses decreased by approximately $1,325,000 to approximately $5,071,000 in fiscal year 2025 from approximately $6,396,000 in fiscal year 2024. General and administrative expenses decreased by approximately $805,000 to approximately $6,630,000 in fiscal year 2025 from approximately $7,435,000 in fiscal year 2024. The company expects to continue incurring material research and development and general and administrative expenses.

The company's operational model conserves funds by collaborating with third parties to develop technologies. As of October 31, 2025, the company had four full-time employees. The company works with research teams at Moffitt and Cleveland Clinic, as well as their and the company's subcontractors, to develop each project. The company leases approximately 2,000 square feet of office space at 3150 Almaden Expressway, San Jose, California, with a base rent of approximately $5,000 per month under a lease that expires September 30, 2027, with an option to extend an additional two years.

During the year ended October 31, 2025, the company raised approximately $2,378,000, net of expenses, through an at-the-market equity offering of 772,001 shares of common stock. Under the at-the-market equity program, as of October 31, 2025, the company may sell up to an additional $100 million of common stock. The company has expected future cash obligations related to the lease of its offices through 2029, inclusive of extension periods, estimated at approximately $256,000. As of October 31, 2025, commitments under certain technology license agreements for the next twelve months were approximately $150,000, and future payments under research and development agreements may be approximately $1.8 million over up to a four-year period.

The company has a history of losses, with an accumulated deficit of approximately $251,677,000 ¹ as of October 31, 2025, and expects to incur additional losses in the future. The therapeutic and vaccine programs are pre-revenue and subject to the risks of an early-stage biotechnology company, with no history of revenue-generating operations from these programs. The company will need additional funding, and as of October 31, 2025, had approximately $15,174,000 ² in cash, cash equivalents and short-term investments, with cash used in operating activities of approximately $7,173,000 ³ in fiscal year 2025. The business model relies on strategic collaborations with commercial partners, and the company may have difficulty establishing these partnerships. The company relies on licenses from Wistar for CAR-T technology and Cleveland Clinic for cancer vaccine technologies, and if any of these licenses are lost, it could remove or limit the ability to develop and commercialize products. The company faces significant competition from larger and better-funded pharmaceutical and biotechnology companies.

Management's message emphasizes the company's transition to a biotechnology company focused on oncology, with the development of therapeutics and vaccines expected to be the primary focus over the next several quarters. The tone is cautiously optimistic, highlighting positive clinical data while acknowledging the uncertainties inherent in drug development. Key strategic priorities include advancing the breast cancer vaccine toward a Phase 2 clinical trial in the neo-adjuvant setting, continuing the dose-escalation Phase 1 trial of lira-cel for ovarian cancer, and progressing the ovarian cancer vaccine through the NCI's PREVENT program. Management states that the company hopes to achieve a profitable outcome by eventually licensing technologies to large pharmaceutical companies, but notes that the eventual licensing may take several years, if it is to occur at all, and may depend on positive results from human clinical trials.