The Future of Cancer Immunotherapy & Women’s Health

Anixa Biosciences (NASDAQ: ANIX) is pioneering CAR-T for solid tumors and vaccine technologies to prevent and treat cancer.

Company Information

  • Clinical-stage biotechnology company focused on developing innovative treatments and preventive strategies for cancer, with an emphasis on solid tumors.
  • Next-generation CAR-T platform designed to overcome traditional CAR-T limitations through:
    • Safe and precise tumor targeting
    • Anti-angiogenic effects
    • Localized delivery to solid tumors
  • Ovarian cancer immunotherapy program in collaboration with Moffitt Cancer Center.
  • Novel solid tumor-specific CAR-T therapy addressing key challenges such as trafficking, tumor infiltration, and resistance within the tumor microenvironment.
  • Vaccine portfolio with Cleveland Clinic targeting:
    • Breast cancer
    • Ovarian cancer
    • Additional high-incidence cancers including lung, colon, and prostate
  • Novel vaccine mechanism: immunization against “retired” proteins re-expressed in certain cancers — a first-of-its-kind approach.
  • Collaborative business model leveraging partnerships with world-renowned research institutions to access cutting-edge science, advance development, and position programs for commercialization.

As Featured on the News

WHY NOW?

  • Anticipated FDA interaction and protocol development for Phase 2 – breast cancer vaccine clinical trial
  • Initiation of Cohort 5 (CAR-T Ovarian Cancer)
  • Ongoing patient monitoring and emerging data across trials – Throughout 2026

Investment Highlights

  • Significant TAM Opportunity
    • Breast Cancer Market: $38.35B in 2023 → $89.67B by 2030
    • Ovarian Cancer Market: High unmet need – Avastin alone generates $3B/year revenue from tumor-vascular targeting.
  • Robust Pipeline and Strong Clinical Data
  • Elite Research Collaborations (Cleveland Clinic and Moffitt Cancer Center)
  • Capital Efficient Business Model Total Burn Last Fiscal Year was $7 Million
  • Strong Balance Sheet $16M cash & short-term investments and no debt (7/31/25)
  • Clean Capital Table No warrants and no preferred stock
  • Strong Consistent Insider Buying

Partners and Endorsements

"Triple negative breast cancer is the form of the disease for which we have the least effective treatments," said G. Thomas Budd, M.D. of Cleveland Clinic's Cancer Institute and principal investigator of the Phase 1 breast cancer vaccine study. "Long term, we are hoping that Anixa’s breast cancer vaccine can be a true preventive vaccine that would be administered to individuals who are cancer-free to prevent them from developing this highly aggressive disease."

Dr. Conejo-Garcia, stated, "Anixa and its development partner, Moffitt Cancer Center, have been working together to advance this ovarian cancer therapy and we are excited about the clinical results to date—with the treatment appearing to be safe and well-tolerated, and some patients exhibiting tumor necrosis. If this therapeutic approach is successful, this could enable a major shift in the overall treatment paradigm for ovarian cancer."

Clinical Programs

CAR-T for Ovarian Cancer

  • 12 patients dosed (as of September 2025)
  • IP delivery advantage: local targeting, reduced toxicity
  • One patient alive >28 months since treatment, multiple others significantly outliving their life expectancy.

Breast Cancer Vaccine

  • 35 patients dosed through Phase 1 cohorts
  • 74% achieved protocol-specific immune response
  • Combination with Keytruda showed that vaccine and Keytruda could be used without causing additional adverse side effects
  • Phase 2 starts in the near future in neo-adjuvant setting

Near-Term Catalysts

  • Breast Cancer Vaccine Discussions with the FDA
  • Ovarian CAR-T multiple cohort updates
  • Additional preclinical program data – Ongoing

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