Anixa Biosciences, Inc.

Overview

Biotechnology company developing oncology therapeutics and vaccines to address unmet medical needs.
Core programs include a CAR-T cell therapy for ovarian cancer and vaccine programs for breast and ovarian cancers, plus a vaccine discovery effort targeting other high-incidence cancers.

Chimeric endocrine receptor-targeted CAR-T therapy focused on ovarian cancer.
Licensed to Certainty Therapeutics, Inc. (a subsidiary) under an exclusive worldwide, royalty-bearing license from The Wistar Institute.
Wistar initially received 5% of Certainty’s common stock; Wistar’s stake was 4.1% as of October 31, 2025.
Collaboration partner: Moffitt Cancer Center and Research Institute. Phase 1 trial began enrollment following FDA authorization in 2022.
Trial design: dose-escalation study with two delivery routes (intraperitoneal and intravenous) to determine maximum tolerated dose and assess persistence and efficacy. Planned enrollment up to 24–48 patients across cohorts.
Dose cohort highlights:
- Cohort 1: first patient treated August 2022; additional patients treated May and August 2023 at the same dose level.
- Cohort 2: three patients treated February–June 2024 at a threefold higher dose than Cohort 1.
- Cohort 3: three patients treated November 2024–February 2025 at a tenfold higher dose than Cohort 1.
- Cohort 4: patients treated at a 30-fold higher dose than Cohort 1.
Clinical observations include T cell infiltration and tumor necrosis in some patients; one patient survived more than two years after initial treatment and received FDA approval for re-dosing in October 2024.
Current status: Phase 1 ongoing; completion expected in 2–3 years depending on enrollment and data.

Exclusive worldwide, royalty-bearing license from Cleveland Clinic for an α-lactalbumin–based breast cancer vaccine.
Development focus: vaccination against α-lactalbumin for prevention/treatment, initially targeting triple-negative breast cancer (TNBC).
Phase 1 trial launched October 2021, fully funded by a Department of Defense grant to Cleveland Clinic. Multiple-ascending-dose study to determine maximum tolerated dose and immune response in early-stage TNBC.
Enrollment and cohorts (35 participants total):
- Cohort Ia: 26 participants (post-treatment, high risk of recurrence).
- Cohort Ib: 4 participants (cancer-free women with specific genetic risk opting for prophylactic mastectomy).
- Cohort Ic: 5 participants (TNBC patients on pembrolizumab in the adjuvant setting to evaluate safety with Keytruda).
Phase 1 results (as of December 11, 2025): primary endpoints met; 74% of participants showed antigen-specific T cell responses; vaccine was safe and well tolerated at the MTD, with injection-site irritation as the primary adverse event. Combination with pembrolizumab generated antigen-specific T cell responses without major additional adverse effects.
Trial completion: enrollment completed June 2025; final patient visits October 2025; final data presented December 2025. Results will inform Phase 2 planning, including a potential neoadjuvant study with pembrolizumab.

Exclusive worldwide rights from Cleveland Clinic for an AMHR2-ED–targeted ovarian cancer vaccine.
Development status: preclinical and IND-enabling work in collaboration with Cleveland Clinic.
NCI PREVENT program involvement since May 2021 to support preclinical development, manufacturing, and IND-enabling activities at NCI facilities with no material cost to the company.
In May 2024, entered a Joint Development and Option Agreement with Cleveland Clinic to collaborate on additional vaccines and to identify new targets (lung, colon, prostate cancers).

Program to discover additional vaccine targets for cancers with high incidence (lung, colon, prostate) using the same mechanistic approach as the breast and ovarian vaccines.
Early-stage efforts conducted in collaboration with Cleveland Clinic.

Wistar CAR-T licenses: exclusive worldwide, royalty-bearing, and tied to development milestones. Wistar equity stake was 4.1% as of October 31, 2025.
Cleveland Clinic vaccine licenses: exclusive worldwide, royalty-bearing for the α-lactalbumin breast vaccine and AMHR2-ED ovarian vaccine; royalty and milestone payments apply.
NCI PREVENT: NCI performs preclinical work for the ovarian vaccine with no material cost to the company.
Joint Development and Option Agreement with Cleveland Clinic (May 2024) to collaborate on additional vaccine development and target identification.

Historical revenue sources included technology licensing and sale of patented technologies, including settlements.
ATM equity program in place as of October 31, 2025. In fiscal year 2025, the company raised approximately $2.378 million (net) through the ATM by selling 772,001 shares.
ATM capacity: program allows up to $100 million; approximately $98.6 million remained available as of January 12, 2026.
Fiscal year 2025 highlights:
- Net loss: approximately $11.03 million.
- Net cash used in operating activities: approximately $7.17 million.
- Accumulated deficit (as of October 31, 2025): about $251.7 million.
- Cash, cash equivalents, and short-term investments (as of October 31, 2025): approximately $15.174 million.
- Working capital (as of October 31, 2025): approximately $13.92 million.
The company expects to pursue licensing and partnership opportunities to commercialize its technologies and has indicated it does not expect to generate meaningful revenues from current programs in the near term.
Ongoing dependence on third-party licenses creates exposure to potential license termination or litigation if terms are breached or patents are challenged.

Four full-time employees as of October 31, 2025.
Research and development conducted with Moffitt Cancer Center (CAR-T) and Cleveland Clinic (breast and ovarian vaccines), plus external subcontractors.
Principal offices: approximately 2,000 square feet at 3150 Almaden Expressway, San Jose, CA 95118. Lease runs through September 30, 2027, with a two-year extension option. Base rent approximately $5,000 per month with ~3% annual increases and operating cost escalations.

Regulatory pathways for CAR-T therapies in solid tumors and for cancer vaccines are evolving, which creates uncertainty in development timelines.
The company relies on third-party collaborators for preclinical and clinical work and maintains its portfolio through patents and licensing arrangements.

Advancing lira-cel through a Phase 1 trial in ovarian cancer with dose escalation and observed clinical activity in some patients.
Breast cancer α-lactalbumin vaccine completed a Phase 1 trial with positive immunogenicity and safety results; Phase 2 planning is underway.
Ovarian vaccine is in preclinical/IND-enabling development with NCI PREVENT support.
Joint development efforts with Cleveland Clinic aim to expand vaccine targets beyond breast and ovarian cancers.
Operates with a lean internal team and depends on collaborations and external funding, including equity programs and partnerships, to advance programs.