Anixa Touts Cancer, Vaccine Programs Progress

  Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today provided the following letter to shareholders from the Company's, Chairman and CEO, Dr. Amit Kumar:

To our valued shareholders,

I am excited to highlight our key achievements from the past year and share our upcoming goals and milestones for 2025 at Anixa Biosciences. In 2024, we made remarkable progress in our mission to develop innovative therapies and vaccines to combat cancer, all while maintaining a strong financial foundation that positions us to confidently pursue our ambitious goals.

We utilized only $7 million of cash during the 2024 fiscal year, concluding with $20 million in cash and investments. Our prudent financial management has ensured a strong balance sheet, giving us the flexibility to advance our programs effectively.

At the Society for Immunotherapy of Cancer (SITC) conference on November 8, 2024, we presented positive preliminary Phase 1 data from our breast cancer vaccine trial. The vaccine demonstrated promising results across three patient groups:

• Recurrence Group: Survivors of triple-negative breast cancer (TNBC) concerned about recurrence post-treatment.
• Prevention Group: Women with genetic mutations placing them at high risk of developing breast cancer.
• Therapeutic Group: Women with residual disease following standard-of-care treatment, where the vaccine was combined with Keytruda (pembrolizumab).

We are encouraged by the positive data trends as additional patients are enrolled in all three cohorts. The vaccine demonstrated a strong safety profile, being well tolerated by participants with protocol-defined immune responses observed in over 70% of patients. Looking ahead, a Phase 2 study evaluating the vaccine in the neoadjuvant setting is planned to commence in 2025, marking an important next step in its development.

These early results provide a solid foundation for expanding our vaccine programs. Building on the success of our breast cancer vaccine, we began developing vaccines targeting prostate, lung, and colon cancers, along with other major indications. The collaboration with the National Cancer Institute on our ovarian cancer vaccine also continues to progress. Meanwhile, we broadened our patent portfolio across all development projects, strengthening our intellectual property position.

Concurrently, our CAR-T program targeting ovarian cancer advanced significantly. We completed treatment of the second dose cohort and initiated treatment of the third dose cohort. A patient from the first dose cohort showed a strong response, receiving FDA authorization for a second dose of T cells. This patient remains alive and well 21+ months after initial treatment. Other patients in the trial have also shown encouraging results. These findings offer promising signs that the CAR-T therapy may serve as a successful long-term treatment option, highlighting its potential effectiveness in the fight against ovarian cancer. Unlike conventional CAR-T therapies, which excel in hematological cancers but struggle with solid tumors, our platform shows promise in overcoming this challenge. We believe it may effectively treat ovarian cancer and other solid tumor types.

2025 holds significant promise as we aim to build on the momentum of 2024:

• Breast Cancer Vaccine: Complete the Phase 1 trial, present additional clinical data at scientific conferences, and initiate the Phase 2 trial.
• CAR-T Clinical Trial: Complete treatment of the third, fourth, and fifth dose cohorts and share data updates. Additionally, we plan to initiate pre-clinical studies of our CAR-T's effectiveness on other solid tumors.
• Vaccine Development: Continue development of vaccines for ovarian, lung, prostate, and colon cancers, with progress updates expected throughout the year.

With $20 million in cash and investments, we have a cash runway of over 2.5 years. Our clean capital structure—free of warrants, preferred stock, and debt—positions us well to execute our plans and remain agile in a dynamic environment.

We believe Anixa Biosciences is at the forefront of developing transformative therapies for cancer, driven by science, innovation, and a commitment to improving patient outcomes. Our strong financial foundation and dedicated team ensure that we are well-equipped to achieve our objectives and deliver value to our shareholders.

Thank you for your continued support and belief in our mission. Together, we are making significant strides in the fight against cancer and paving the way for a healthier future.

Sincerely,

Dr. Amit Kumar
Chairman and CEO
Anixa Biosciences

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