Company Strategy - The company has approved the purchase of Bitcoin as a treasury reserve asset to diversify its holdings and benefit from the potential long-term value of digital assets [1] - The company reaffirmed its ongoing stock buyback program as part of its commitment to enhancing shareholder value [2] - The decision to invest in Bitcoin is seen as an additional approach to prudent financial management, enabling greater shareholder value [3] - The company believes Bitcoin's growing recognition as a mainstream asset class, its inflation-resistant qualities, and potential as a reliable store of value align with its goal of optimizing long-term financial stability and growth [4] Clinical Trials and Pipeline - The company's breast cancer vaccine (NCT04674306) and ovarian cancer therapy (NCT05316129) have produced results that exceeded expectations [3] - The company's therapeutic portfolio includes an ovarian cancer immunotherapy program using CER-T technology, developed in collaboration with Moffitt Cancer Center [5] - The company's vaccine portfolio includes vaccines developed in collaboration with Cleveland Clinic to treat and prevent breast and ovarian cancer, as well as additional cancer vaccines targeting lung, colon, and prostate cancers [5] Business Model and Partnerships - The company's unique business model involves partnering with world-renowned research institutions for all stages of development, allowing it to continually examine emerging technologies in complementary fields for further development and commercialization [5]

Company Overview - Anixa Biosciences Inc is a clinical-stage biotechnology company focused on the treatment and prevention of cancer [2] - The company's therapeutic portfolio includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center using CER-T technology [2] - Anixa's vaccine portfolio includes breast cancer and ovarian cancer vaccines developed with Cleveland Clinic, as well as additional cancer vaccines targeting lung, colon, and prostate cancers [2] - The company employs a unique business model of partnering with world-renowned research institutions for technology development and commercialization [2] Upcoming Events - Anixa will present at the Sidoti Micro-Cap Virtual Conference on November 14, 2024 at 1:00pm ET [1] - The presentation will be available via Zoom and 1x1 meetings are open to all registered investors [1] - The company will release updated data from its breast cancer clinical trial on November 8, 2024 [1] Clinical Programs - Anixa's breast cancer clinical trial is producing very positive results, exceeding expectations [1] - The company's CAR-T trial for recurrent and resistant ovarian cancer patients is also showing promising results [1] - Both clinical trials are generating significant positive outcomes that will be updated in the upcoming presentation [1]

Company Announcement - Anixa Biosciences appoints Suyasha Gupta as Senior Director of Clinical Development to oversee Phase 1 breast cancer vaccine, Phase 1 ovarian cancer CAR-T therapy, and upcoming Phase 2 breast cancer vaccine trials [1] - Suyasha Gupta brings extensive experience in late-stage oncology and hematology clinical trials, previously managing Phase 2 and 3 studies at Genentech [2] - Dr Pamela Garzone highlights Gupta's expertise in oncology and late-stage clinical trials as critical for advancing Anixa's pipeline [3] Clinical Development Strategy - Anixa's breast cancer vaccine Phase 2 trial will focus on a therapeutic approach rather than prevention, aiming for faster regulatory approval and cost-effectiveness [4] - The vaccine targets α-lactalbumin, a "retired" protein present in certain breast cancers, with an adjuvant to activate an innate immune response [5] - Initial Phase 1 data showed no safety concerns and protocol-defined immune responses in a majority of patients [6] Collaborations and Funding - Anixa collaborates with Cleveland Clinic on the breast cancer vaccine Phase 1 trial, funded by a U S Department of Defense grant [6] - The vaccine technology was invented by Dr Vincent Tuohy, with Cleveland Clinic exclusively licensing it to Anixa [7][8] Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a portfolio including ovarian cancer immunotherapy and breast cancer vaccines [9] - The company partners with renowned research institutions like Cleveland Clinic and Moffitt Cancer Center for development and commercialization [9]

Strategic Plan for Phase 2 Study - The company announced its strategic plan for a Phase 2 study of its breast cancer vaccine, which will evaluate the vaccine's efficacy in combination with chemotherapy and Keytruda (pembrolizumab) in the neoadjuvant setting [1][2] - The Phase 2 trial aims to reduce tumor burden, prevent recurrence, and improve survival, while enrolling a broader range of patients with multiple types of breast cancer [2] - The trial is expected to commence in 2025 and last approximately two to three years, with immunological responses to the vaccine being made available as the trial progresses [3] Market and Therapeutic Approach - The therapeutic market for breast cancer is large, valued at approximately $38.35 billion in 2023 and projected to reach $89.67 billion by 2030, growing at a CAGR of 12.9% [2] - The development path for breast cancer treatment is expected to have a shorter path to approval compared to primary prevention, covering all stages of breast cancer from early to advanced and metastatic cases [2] - The company's approach focuses on targeting treatment rather than prevention, which allows for a broader patient population and potentially expedites regulatory approval and partnerships [4] Vaccine Technology and Mechanism - The breast cancer vaccine targets endogenously produced proteins, such as α-lactalbumin, which are present in certain breast cancers but not in normal, aging tissues [6] - The vaccine activates the immune system against these "retired" proteins, providing preemptive immune protection against emerging breast tumors that express α-lactalbumin [6] - The vaccine also contains an adjuvant that activates an innate immune response, enabling the immune system to mount a response against emerging tumors to prevent their growth [6] Collaboration and Funding - The Phase 1 trial is conducted in collaboration with Cleveland Clinic and funded by a grant from the U S Department of Defense [5] - The company is the exclusive worldwide licensee of the novel breast cancer vaccine technology developed at Cleveland Clinic [5][7] - The late Dr Vincent Tuohy, who invented the vaccine technology, was entitled to a portion of the commercialization revenues received by Cleveland Clinic and held equity in the company [7][8] Company Overview and Portfolio - The company is a clinical-stage biotechnology company focused on the treatment and prevention of cancer, with a therapeutic portfolio including an ovarian cancer immunotherapy program and a vaccine portfolio targeting breast and ovarian cancers [9] - The company's vaccine technologies focus on immunizing against "retired" proteins expressed in certain forms of cancer, including triple-negative breast cancer (TNBC), lung, colon, and prostate cancers [9] - The company's business model involves partnering with world-renowned research institutions for development and commercialization of emerging technologies in complementary fields [9]

Revenue and Financial Performance - Revenue for the three months ended July 31, 2024 and 2023 was $0, with no significant revenue expected from legacy patent licensing activities[86][95] - Revenue recognition is based on one-time, paid-up license fees, with 100% of revenue recognized upon execution of licensing agreements[111] Research and Development Expenses - Research and development expenses increased by $837,000 to $1,925,000 in Q3 2024, driven by higher expenses in breast cancer vaccine ($694,000) and CAR-T therapeutics ($235,000) programs[89] - Research and development expenses for the nine months ended July 31, 2024 totaled $4,920,000, a $1,766,000 increase from 2023, driven by breast cancer vaccine ($1,088,000) and CAR-T therapeutics ($642,000) programs[99] - Research and development expenses are recognized as incurred, with advance payments deferred and expensed as services are performed[117] - Preclinical and clinical trial expenses are recognized based on services performed under contracts with research institutions, CROs, and CMOs[117] - Management estimates prepaid and accrued R&D costs by discussing progress with internal and external service providers and comparing to payments and invoices[118] - Internal compensation costs are allocated to R&D expenses based on management's estimates of employee time and effort[118] General and Administrative Expenses - General and administrative expenses decreased by $89,000 to $1,667,000 in Q3 2024, primarily due to reduced director stock option compensation ($97,000) and director fees ($53,000)[90] - General and administrative expenses for the nine months ended July 31, 2024 increased by $893,000 to $5,748,000, primarily due to higher investor and public relations expenses ($611,000) and employee stock option compensation ($128,000)[100] Interest Income and Investments - Interest income decreased by $19,000 to $277,000 in Q3 2024 due to lower average short-term investment balances, despite higher interest rates[92] - Interest income for the nine months ended July 31, 2024 increased by $132,000 to $883,000 due to higher interest rates and increased short-term investment balances[101] - Cash, cash equivalents, and short-term investments decreased by $3,099,000 to $20,745,000 as of July 31, 2024, with the company raising $2,984,000 through an at-the-market equity offering[104][106] Cash Reserves and Funding - The company expects its current cash reserves to fund operations for at least the next 12 months, with the ability to raise an additional $97 million through its at-the-market equity program[104] Stock Option Valuation and Assumptions - The company uses the Black-Scholes pricing model and Monte Carlo Simulation to estimate fair value, requiring assumptions on expected term, volatility, risk-free interest rates, and dividend yield[115] - The expected term for employee stock options is determined using a simplified method, combining vesting and contractual terms, due to operational changes impacting historical performance[115] - The company estimates expected volatility based on historical share price volatility over a period equal to the expected term of the grants[115] - The risk-free interest rate is estimated using the implied yield of U.S. Treasury notes with terms matching the expected term of the grants[115] - The company assumes no dividend yield based on its history and expectation of not paying dividends in the future[115] Disclosure Controls and Procedures - The company's disclosure controls and procedures were deemed effective as of the end of the reporting period[120]

Company Overview - Anixa Biosciences Inc is a clinical-stage biotechnology company focused on the treatment and prevention of cancer [3] - The company's therapeutic portfolio includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center, utilizing a novel CAR-T technology called chimeric endocrine receptor T-cell (CER-T) [3] - Anixa's vaccine portfolio includes breast cancer and ovarian cancer vaccines developed in collaboration with Cleveland Clinic, targeting "retired" proteins expressed in certain cancers [3] - The company partners with world-renowned research institutions to examine emerging technologies for further development and commercialization [3] Technology and Clinical Trials - Anixa's CAR-T technology targets the follicle stimulating hormone receptor (FSHR), found exclusively on ovarian granulosa cells, making it a unique approach known as CER-T therapy [2] - The company will present Phase I clinical trial results of its FSHR-mediated CAR-T therapy for recurrent ovarian cancer at the International Gynecologic Cancer Society (IGCS) 2024 Annual Global Meeting [1] - The clinical trial presentation will be led by Dr Robert Wenham, Chair of Gynecologic Oncology at Moffitt Cancer Center, Anixa's collaboration partner [1] - The FSHR-mediated CAR-T technology was developed by Dr Jose R Conejo-Garcia at Duke University School of Medicine, with Anixa holding an exclusive worldwide license from The Wistar Institute [2]

Clinical Trial Progress - Anixa Biosciences' collaborator, Moffitt Cancer Center, received FDA approval for a second dose of CAR-T therapy for a patient showing clinical activity after initial treatment [1] - In the first cohort at the lowest dose, one patient exhibited tumor necrosis, inflammation, and T cell infiltration, with tumor markers initially rising then falling, leading to FDA approval for a second treatment [2] - The Phase I trial is treating recurrent ovarian cancer patients who have failed standard therapies, with six patients treated so far across two cohorts, and dose escalation continuing after confirming safety [3] Company Overview - Anixa Biosciences is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a therapeutic portfolio including an ovarian cancer immunotherapy program using CER-T technology [4] - The company's vaccine portfolio, developed with Cleveland Clinic, targets triple-negative breast cancer, ovarian cancer, and other intractable cancers by immunizing against "retired" proteins expressed in certain cancers [4] - Anixa partners with renowned research institutions to examine emerging technologies for further development and commercialization [4]

Patent and Clinical Development - Anixa Biosciences collaborator, Cleveland Clinic, received a "Decision to Grant" notice from the Japan Patent Office for the patent application titled "Vaccine Adjuvants and Formulations" [1] - The Japanese patent extends the claims for the novel breast cancer vaccine technology to an additional geographic region, beyond the U.S. and European patents previously awarded [1] - The vaccine is currently being studied in a phase one clinical trial at Cleveland Clinic [1] Vaccine Technology - The breast cancer vaccine targets endogenously produced proteins, such as α-lactalbumin, which are no longer found post-lactation in normal, aging tissues but are present in certain breast cancers [2] - The vaccine activates the immune system against these "retired" proteins, providing preemptive immune protection against emerging breast tumors that express α-lactalbumin [2] - The vaccine contains an adjuvant that activates an innate immune response, enabling the immune system to mount a response against emerging tumors to prevent them from growing [2] Inventor and Licensing - The vaccine technology was invented by the late Dr. Vincent Tuohy, who held the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research at Cleveland Clinic's Lerner Research Institute [3] - Cleveland Clinic exclusively licensed this technology to Anixa Biosciences [3] - Dr. Tuohy was entitled to a portion of the commercialization revenues received by Cleveland Clinic and also held equity in Anixa [3] Company Overview - Anixa Biosciences is a clinical-stage biotechnology company focused on the treatment and prevention of cancer [4] - The company's therapeutic portfolio includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center, using chimeric endocrine receptor T-cell (CER-T) technology [4] - Anixa's vaccine portfolio includes vaccines being developed in collaboration with Cleveland Clinic to prevent breast cancer, specifically triple negative breast cancer (TNBC), and ovarian cancer, as well as additional cancer vaccines targeting high incidence malignancies in lung, colon, and prostate [4] - The company's business model involves partnering with world-renowned research institutions for development and commercialization of emerging technologies [4]

SAN JOSE, Calif., July 15, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that its Board of Directors has authorized a share repurchase program of up to $5 million of the Company's outstanding common stock. "This share repurchase program reflects our confidence in the future outlook of our business, the soundness of our balance sheet, the strength of our clinical development pi ...

Core Viewpoint - Anixa Biosciences is advancing its Phase 1 clinical trial of a novel CAR-T therapy for ovarian cancer, with the sixth patient treated in the second dosage cohort, potentially leading to the enrollment of a third cohort soon if safety continues to be confirmed [1][2]. Group 1: Clinical Trial Progress - The sixth patient treated is expected to be the last in the second dosage cohort, with plans to escalate to a third cohort if no adverse effects are observed [1]. - The second cohort received triple the dose of CAR-T cells compared to the first cohort, with no dose-limiting toxicities reported [2]. - The trial will begin enrolling patients in the third dose cohort at a ten times higher dose than the initial dosage after a one-month wait for safety confirmation [3]. Group 2: Technology and Mechanism - Anixa's CAR-T technology targets the follicle-stimulating hormone receptor (FSHR), which is exclusively expressed on ovarian cells, including tumor vasculature [2]. - The therapy aims to utilize a dual mechanism of action by targeting tumor vasculature and ovarian cells, potentially making CAR-T effective in solid tumors like ovarian cancer [4]. - The intraperitoneal (IP) delivery method is expected to enhance targeting and improve the safety profile by minimizing side effects such as cytokine release syndrome [4]. Group 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 [5]. - The company is also developing vaccines for triple negative breast cancer and other cancers, utilizing a unique business model that partners with renowned research institutions [5].