Anixa Biosciences CEO Provides Letter to Shareholders

Rhea-AI Summary

Anixa Biosciences (NASDAQ: ANIX) reported significant progress in 2024, maintaining strong financials with $20 million in cash and investments after using only $7 million during the fiscal year. The company presented positive preliminary Phase 1 data for their breast cancer vaccine at SITC, showing protocol-defined immune responses in over 70% of patients across three groups: recurrence, prevention, and therapeutic.

Their CAR-T program for ovarian cancer progressed through the second dose cohort and began the third, with one patient from the first cohort showing strong response and surviving 21+ months post-treatment. The company expanded their vaccine development to include prostate, lung, and colon cancers.

For 2025, Anixa plans to complete the breast cancer vaccine Phase 1 trial and initiate Phase 2, complete treatment of third through fifth dose cohorts in the CAR-T trial, and continue developing vaccines for multiple cancer types. With a 2.5-year cash runway and debt-free structure, the company is positioned to execute its development plans.

Positive

• Strong financial position with $20M cash/investments and 2.5-year runway
• 70% of patients showed immune response in breast cancer vaccine Phase 1 trial
• Successful patient response in CAR-T trial with 21+ months survival
• Clean capital structure with no warrants, debt, or preferred stock
• Efficient cash management with only $7M used in 2024

Negative

• Phase 1 trials still in preliminary stages
• Multiple vaccine programs in early development stages requiring significant resources

Insights

Biotech Research Analyst

This shareholder letter reveals substantial clinical and financial progress. The company's $20M cash position provides a remarkable 2.5-year runway with minimal cash burn of $7M in 2024, demonstrating efficient capital management for a clinical-stage biotech.

The breast cancer vaccine program shows particular promise, with over 70% of patients exhibiting protocol-defined immune responses across three distinct cohorts. The planned Phase 2 trial in 2025 represents a important value inflection point. The CAR-T program's 21+ month survival data in ovarian cancer is noteworthy, as achieving durable responses in solid tumors has been an industry-wide challenge.

The expansion into multiple cancer vaccine indications (prostate, lung, colon) leveraging their platform technology presents significant market opportunity. The clean capital structure, free of dilutive instruments, positions them favorably for potential partnerships or capital raises.

Clinical Oncologist

The preliminary efficacy signals from both lead programs are scientifically meaningful. The breast cancer vaccine's immune response rate exceeding 70% is impressive, particularly given its novel triple-cohort approach targeting different patient populations. The therapeutic cohort combining the vaccine with Keytruda could potentially enhance immunotherapy outcomes.

The CAR-T data in ovarian cancer is particularly intriguing. Extended survival of 21+ months in a patient receiving a second dose suggests potential durability of response - a critical factor in solid tumor immunotherapy. The sequential dose-escalation approach through five cohorts is methodologically sound for safety assessment.

The diversification into multiple cancer types indicates platform scalability, though success in one indication doesn't guarantee efficacy across all targets. The clean safety profile reported thus far is encouraging for future development.

Financial Strategist

The company's financial strategy stands out in the biotech sector. Annual cash burn of $7M is remarkably efficient for a company advancing multiple clinical programs. The $20M cash position providing 2.5 years of runway significantly de-risks near-term operations and strengthens negotiating positions for potential partnerships.

The absence of warrants, preferred stock and debt is a significant advantage in the current market environment. This clean capital structure preserves flexibility for future financing options and makes the company more attractive to institutional investors and potential acquirers. The expanding patent portfolio across multiple programs adds valuable intellectual property assets to the balance sheet.

SAN JOSE, Calif., Jan. 21, 2025 /PRNewswire/ -- 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

About Anixa Biosciences, Inc.
Anixa is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. Anixa's therapeutic portfolio consists of an ovarian cancer immunotherapy program being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-T, known as chimeric endocrine receptor-T cell (CER-T) technology. The Company's vaccine portfolio includes vaccines being developed in collaboration with Cleveland Clinic to treat and prevent breast cancer and ovarian cancer, as well as additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung, colon, and prostate. These vaccine technologies focus on immunizing against "retired" proteins that have been found to be expressed in certain forms of cancer. Anixa's business model of partnering with world-renowned research institutions on all stages of development allows the Company to continually examine emerging technologies in complementary fields for further development and commercialization. To learn more, visit www.anixa.com or follow Anixa on Twitter, LinkedIn, Facebook and YouTube.

Forward-Looking Statements
Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect Anixa's current expectations concerning future events and results. We generally use the words "believes," "expects," "intends," "plans," "anticipates," "likely," "will" and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in "Item 1A - Risk Factors" and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.

Contact:
Mike Catelani
President, COO & CFO
mcatelani@anixa.com
408-708-9808

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SOURCE Anixa Biosciences, Inc.

FAQ

What are the key results from ANIX's breast cancer vaccine Phase 1 trial?

The Phase 1 trial showed protocol-defined immune responses in over 70% of patients, with the vaccine being well-tolerated across three groups: recurrence prevention in TNBC survivors, prevention in high-risk individuals, and therapeutic treatment combined with Keytruda.

How much cash does ANIX have and what is their burn rate?

Anixa has $20 million in cash and investments as of January 2025, with a cash burn of $7 million during fiscal 2024, providing a runway of over 2.5 years.

What are ANIX's main development programs for 2025?

ANIX plans to complete the breast cancer vaccine Phase 1 trial and start Phase 2, complete CAR-T trial dose cohorts 3-5, and continue developing vaccines for ovarian, lung, prostate, and colon cancers.

What results has ANIX seen in their ovarian cancer CAR-T program?

A patient from the first dose cohort showed strong response and received FDA authorization for a second dose, remaining alive after 21+ months post-treatment. The program has completed the second dose cohort and initiated the third.