PresentationRobert SassoonWater Tower Research LLC Hello, everybody. I'm Robert Sassoon. I cover health care at Water Tower Research. Today, I have the pleasure of being joined in this fireside chat by Anixa Biosciences' Chairman and CEO, Dr. Amit Kumar. Anixa is a clinical stage biotech company, which develops a novel type of CAR-T cell therapy for the treatment of termly ill ovarian cancer patients and separately, a vaccine for the treatment and prevention of breast cancer. Anixa has also additional pred ...

Core Insights - Anixa Biosciences has received a patent for its breast cancer vaccine technology, which targets the -lactalbumin protein, a promising approach for immunoprevention strategies against breast cancer [1][2][3] Company Overview - Anixa Biosciences is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a strong emphasis on developing next-generation preventive immunotherapies [2][5] - The company has a collaboration with Cleveland Clinic for the development of its breast cancer vaccine, which is part of a broader portfolio that includes ovarian cancer immunotherapy [5] Patent and Intellectual Property - The U.S. Patent Number 12,472,205 will be issued on November 18, 2025, extending the intellectual property protection for Anixa's breast cancer vaccine technology into the mid-2040s [1][2] - This patent reinforces the company's commitment to addressing breast cancer, which is projected to affect nearly 300,000 women in the U.S. by 2026 [1][3] Market Need - Breast cancer remains the most commonly diagnosed cancer among women globally, with over 297,000 new cases expected in the U.S. in 2025 and approximately 43,000 deaths anticipated [3] - There is currently no FDA-approved vaccine for breast cancer prevention, highlighting a significant unmet need in preventive oncology [3] Vaccine Mechanism - Anixa's investigational vaccine aims to stimulate the immune system to recognize and eliminate cells expressing -lactalbumin while sparing normal tissue, potentially minimizing off-target effects [4]

Core Insights - Anixa Biosciences has completed the final patient visit in its breast cancer vaccine clinical trial, marking a significant milestone in the first-in-human evaluation of the vaccine [1][3] - The vaccine aims to stimulate the immune system to recognize and target breast cancer before recurrence or development [2] - Preliminary results indicate that over 70% of participants demonstrated immune responses, suggesting the vaccine is well tolerated [4] Company Overview - Anixa Biosciences is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a portfolio that includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center [5] - The company is developing vaccines for breast and ovarian cancer in partnership with Cleveland Clinic, which has exclusive licensing rights to these technologies [5] - Anixa's business model involves partnering with leading research institutions to explore emerging technologies for cancer treatment [5] Clinical Trial Details - The Phase 1 trial included 35 women across three cohorts: 26 in the TNBC group, 4 in the Prevention group, and 5 in the Pembrolizumab group [2][6] - Comprehensive data analysis will follow the completion of patient visits, with results to be submitted to the Department of Defense and the FDA [3] - Full clinical results are scheduled to be presented at the San Antonio Breast Cancer Symposium on December 11, 2025 [3]

Core Insights - Anixa Biosciences has initiated the transfer of the Investigational New Drug (IND) application for its breast cancer vaccine, which is currently held by Cleveland Clinic, to advance to a Phase 2 clinical trial [1][2][4] - The Phase 1 clinical trial has shown promising results, with over 70% of patients exhibiting immune responses, indicating the vaccine's potential effectiveness [2][4] - The breast cancer vaccine targets α-lactalbumin, a protein associated with lactation that re-emerges in many breast cancer forms, suggesting both therapeutic and preventive benefits [3][4] Company Overview - Anixa Biosciences is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a portfolio that includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center [5] - The company is developing vaccines for breast and ovarian cancer, as well as other cancers, utilizing technologies that target proteins expressed in certain cancer forms [5] - Anixa's business model involves partnerships with leading research institutions to explore and commercialize emerging technologies in cancer treatment [5]

Core Insights - Anixa Biosciences has received a Notice of Allowance for a new patent in Canada related to its breast cancer vaccine technology, enhancing its international intellectual property portfolio [1][2][3] - The patent provides composition-of-matter protection for Anixa's immunogenic approach to breast cancer prevention and treatment, which is exclusively licensed from Cleveland Clinic [1][4] - Breast cancer is the most commonly diagnosed cancer in women globally, accounting for approximately 25% of new cancer cases in women in Canada and 13% of female cancer deaths annually [3] Intellectual Property Expansion - The newly allowed Canadian patent complements existing and pending patents in the United States and other key global jurisdictions, reinforcing Anixa's leadership in cancer immunoprevention [2][5] - This expansion of the patent estate is crucial for future regulatory and commercial efforts outside the U.S., positioning the company for strategic global opportunities [2][3] Vaccine Technology - Anixa's breast cancer vaccine targets human α-lactalbumin, a protein aberrantly expressed in certain breast cancers, aiming to prime the immune system to prevent tumor formation while sparing normal tissue [4][5] - The company's broader vaccine platform also addresses other high-incidence cancers, transforming the approach to cancer prevention in the medical community [5] Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a therapeutic portfolio that includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center [6] - The company partners with renowned research institutions to develop vaccines targeting various cancers, including breast and ovarian cancer, utilizing a unique business model that allows for continuous examination of emerging technologies [6]

Core Viewpoint - Anixa Biosciences has received a patent for its breast cancer vaccine technology, which addresses a significant unmet need in preventive oncology and has the potential for a multi-billion dollar market opportunity [1][2][5]. Company Overview - Anixa Biosciences is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a portfolio that includes a breast cancer vaccine developed in collaboration with Cleveland Clinic [7]. - The company has a unique business model of partnering with renowned research institutions for all stages of development, allowing for continuous examination of emerging technologies [7]. Patent and Technology - The U.S. Patent Number 12,370,244 will be issued on July 29, 2025, covering methods of immunizing patients against breast cancer using human α-lactalbumin protein [1][2]. - The patent extends foundational protection for the breast cancer vaccine program into the mid-2040s, enhancing Anixa's ability to develop and commercialize immunopreventive solutions [2][6]. Market Opportunity - The breast cancer vaccine platform represents a potential multi-billion dollar market, particularly for women at elevated risk of developing triple-negative breast cancer (TNBC) [5]. - In the U.S., over 297,000 new cases of invasive breast cancer are projected in 2025, highlighting the significant need for preventive solutions [3]. Vaccine Mechanism - The investigational vaccine aims to stimulate the immune system to recognize and eliminate pre-malignant and malignant cells expressing α-lactalbumin while sparing normal tissue [4]. - By targeting this protein, which is generally absent from adult tissues except during lactation, the vaccine may minimize off-target effects and provide long-lasting immune protection [4].

Core Viewpoint - Anixa Biosciences has announced the issuance of a key patent for its ovarian cancer vaccine technology, which is expected to enhance the company's position in the cancer treatment market [1][4]. Group 1: Patent and Technology - The United States Patent and Trademark Office (USPTO) will issue U.S. Patent Number 12,357,593 on July 15, 2025, covering methods related to eliciting an immune response targeting anti-Müllerian hormone receptor, type II (AMHR2) [1]. - The patent includes methods for administering an immunogenic composition that encodes the AMHR2 polypeptide, specifically targeting the extracellular domain of human AMHR2 [3]. - Anixa holds exclusive worldwide rights to the patent, which was issued to Cleveland Clinic [3]. Group 2: Collaboration and Development - The ovarian cancer vaccine is being developed in collaboration with Cleveland Clinic and the National Cancer Institute, focusing on high-risk populations such as those with BRCA mutations [2]. - Anixa's therapeutic portfolio includes an ovarian cancer immunotherapy program utilizing chimeric endocrine receptor-T cell (CER-T) technology, which is distinct from traditional CAR-T therapies [4]. - The company is also developing additional cancer vaccines in collaboration with Cleveland Clinic to address various cancers, including breast, lung, colon, and prostate cancers [4].

Core Insights - Anixa Biosciences, Inc. is advancing a breast cancer vaccine that aims to train the immune system to identify and eliminate cancerous cells before they develop into invasive tumors [2][3] - The vaccine specifically targets α-lactalbumin, a protein expressed in the breast during lactation, which is also found in malignant breast cancer cells [2] - The company has completed enrollment in the Phase 1 clinical trial for the vaccine and is optimistic about its potential impact on breast cancer treatment and prevention [3] Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a portfolio that includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center [4] - The company utilizes a unique CAR-T technology known as chimeric endocrine receptor-T cell (CER-T) technology, which differentiates itself by targeting the natural ligand of the FSHR receptor on tumor cells [4] - Anixa's vaccine portfolio includes collaborations with Cleveland Clinic to develop vaccines for breast and ovarian cancer, as well as other cancers such as lung, colon, and prostate [4]

Financial Data and Key Metrics Changes - The company has a strong balance sheet with $17 million in cash, providing a runway of approximately 2.5 years, which is considered ample in the current industry context [6][9][13] - Historical cash burn averages between $5 million and $7 million per year, indicating a capital-efficient business model [8][15] Business Line Data and Key Metrics Changes - The company is advancing two lead clinical programs: a breast cancer vaccine and an ovarian cancer CAR T therapy, both currently in Phase 1 clinical trials with promising clinical data [3][16] - The breast cancer vaccine is funded by a U.S. Government grant, which helps keep cash burn low [17][34] Market Data and Key Metrics Changes - The breast cancer market is large and well-known, while the ovarian cancer market, though smaller, presents a significant unmet medical need with poor outcomes [5] - The company is targeting both neoadjuvant and primary prevention markets for its breast cancer vaccine, indicating a broad market strategy [40] Company Strategy and Development Direction - The company leverages partnerships with top-tier academic institutions like Moffitt Cancer Center and Cleveland Clinic to enhance its research capabilities without incurring high costs [4][10] - The strategy focuses on advancing clinical programs through early stages and partnering with pharmaceutical companies for later-stage development and commercialization [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical data being generated, particularly regarding the safety and efficacy of the ovarian cancer CAR T therapy, with encouraging survival rates observed in treated patients [27][28] - The company aims to present final data from the Phase 1 trial of the breast cancer vaccine at the San Antonio Breast Cancer Symposium in December, indicating a proactive approach to sharing results [39] Other Important Information - The company has maintained consistent insider buying over the years, reflecting management's confidence in the business [7] - There are no outstanding warrants, preferred stock, or debt, which positions the company favorably for future financing [13] Q&A Session Summary Question: What is the current status of the ovarian cancer CAR T therapy? - The therapy is in Phase 1 trials, with encouraging safety profiles and overall survival rates observed in treated patients [27][28] Question: How is the breast cancer vaccine funded? - The breast cancer vaccine is fully funded by a U.S. Government grant, which helps minimize cash burn [17][34] Question: What are the next steps for the breast cancer vaccine program? - The company plans to present final data from the Phase 1 trial at the San Antonio Breast Cancer Symposium in December and is preparing for a Phase 2 trial [39][40]

Core Points - Anixa Biosciences has received a Notice of Allowance for a new patent related to its breast cancer vaccine technology, which broadens the scope of immunogenic compositions used in the vaccine [1][2] - The patent covers methods of immunizing patients against breast cancer using an immunogenic composition containing the human α-lactalbumin protein, which is expressed in certain breast cancers [2] - The CEO of Anixa highlighted that this patent enhances the company's intellectual property portfolio, which includes multiple issued and pending patents in the U.S. and internationally [3] Company Overview - Anixa Biosciences is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a therapeutic portfolio that includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center [3] - The company's vaccine portfolio includes vaccines for breast and ovarian cancer, as well as other cancer vaccines targeting high incidence malignancies such as lung, colon, and prostate cancers [3] - Anixa's business model involves partnerships with renowned research institutions, allowing the company to explore emerging technologies for further development and commercialization [3]