Clinical Trials and Development Programs - Certainty has treated six patients in Phase 1 clinical trials for ovarian cancer CAR-T therapy, with two patients showing anecdotal signs of efficacy, including tumor necrosis and one patient being 20 months past initial treatment[17] - The Phase 1 clinical trial for ovarian cancer CAR-T therapy is expected to be completed in two to three years, involving 24 to 48 patients[18] - The breast cancer vaccine Phase 1 trial has shown antigen-specific T cell responses in vaccinated women at all dose levels, with no adverse side effects other than injection site irritation[21] - The company plans to initiate a Phase 2 clinical trial for the breast cancer vaccine in 2025, focusing on the neo-adjuvant setting[21] - The company entered into a Joint Development and Option Agreement with Cleveland Clinic in May 2024 to develop additional cancer vaccines targeting high incidence malignancies in the lung, colon, and prostate[25] - The company is developing a CAR-T therapy for ovarian cancer and vaccines for breast and ovarian cancers[238] - The Phase 1 CAR-T ovarian cancer clinical trial is enrolling patients with late-stage ovarian cancer who have failed conventional treatment[93] - The Phase 1a breast cancer vaccine clinical trial is enrolling patients who have undergone standard of care treatment for TNBC[93] - The Phase 1b breast cancer vaccine clinical trial is enrolling healthy women with BRCA1, BRCA2, or PALB2 gene mutations who have elected prophylactic mastectomies[93] Financial Performance and Expenses - Research and development expenses increased by $1.627 million to $6.396 million in fiscal year 2024, driven by CAR-T and breast cancer vaccine programs[172] - General and administrative expenses rose by $1.144 million to $7.435 million in fiscal year 2024, primarily due to investor relations and employee compensation costs[173] - Research and development expenses for cancer vaccines and CAR-T therapeutics were $3.748 million and $2.648 million, respectively, in fiscal year 2024[171] - Research and development expenses increased to $6.4 million in 2024 from $4.8 million in 2023, reflecting a 34.1% year-over-year growth[231] - Net loss attributable to common shareholders widened to $12.6 million in 2024 from $9.8 million in 2023, a 28.0% increase[231] - Total operating costs and expenses increased to $13.8 million in 2024 from $11.2 million in 2023, a 23.3% rise[231] - Net loss per share increased to $0.39 in 2024 from $0.32 in 2023, a 21.9% increase[231] - Net loss for the year ended October 31, 2024, was $12.7 million, compared to $9.9 million in 2023[236] - Net cash used in operating activities for 2024 was $7.3 million, compared to $6.2 million in 2023[236] - Disbursements to acquire short-term investments in 2024 were $63.8 million, compared to $44.4 million in 2023[236] - Proceeds from maturities of short-term investments in 2024 were $68.0 million, compared to $38.8 million in 2023[236] - Net cash provided by financing activities in 2024 was $3.4 million, compared to $0.4 million in 2023[236] - Cash and cash equivalents at the end of 2024 were $1.3 million, compared to $0.9 million in 2023[236] - The company reported a net loss of $12.7 million for the year ended October 31, 2024, with Cancer Vaccines and CAR-T Therapeutics segments contributing $7.39 million and $5.26 million, respectively[307] - The company had no revenue in 2024, compared to $210,000 in 2023, which was solely generated from the Other segment[308] - The company raised approximately $2.96 million through an at-the-market equity offering in 2024 and may sell up to $97 million of common stock under its current equity program[67] - The company believes its existing cash and short-term investments will fund operations for at least the next twelve months, but may require additional funding through equity sales or debt, potentially diluting stockholders[67] - The company had approximately $19,924,000 in cash, cash equivalents, and short-term investments as of October 31, 2024[68] - The company does not generate any revenue from its therapeutics or vaccines and expects no significant revenue in the foreseeable future[68] - The company may need additional funding sooner than anticipated due to rapid resource consumption[68] - Interest income increased to $1,133,000 in fiscal year 2024, up from $1,081,000 in fiscal year 2023, driven by higher interest rates and increased average short-term investment holdings[174] - Cash and cash equivalents rose to $1.3 million in 2024 from $0.9 million in 2023, a 38.9% increase[228] - Short-term investments decreased to $18.7 million in 2024 from $22.9 million in 2023, a 18.6% decline[228] - Total current assets decreased to $21.4 million in 2024 from $25.4 million in 2023, a 15.7% decline[228] - Total liabilities increased to $2.7 million in 2024 from $2.2 million in 2023, a 25.7% rise[228] - Additional paid-in capital grew to $260.4 million in 2024 from $252.2 million in 2023, a 3.3% increase[234] - Accumulated deficit expanded to $240.8 million in 2024 from $228.2 million in 2023, a 5.5% increase[234] Intellectual Property and Licensing - The company relies on licenses from Wistar for CAR-T technology and Cleveland Clinic for cancer vaccine technologies, with potential risks if these licenses are terminated[117] - The company faces risks related to intellectual property disputes, which could impact its ability to commercialize products[116] - The company's revenue recognition policy involves complex judgments, particularly regarding technology licensing and intellectual property transfers[183] - Failure to maintain licenses could result in litigation, damages, and potential product sales restrictions, adversely affecting the company's operations and financial condition[122] - Disclosure or misappropriation of proprietary technology could erode the company's competitive position in the market[123] - Uncertainty regarding the issuance, validity, and enforceability of patents could impact the company's ability to protect its product candidates[124][125] - Delays in clinical trials could reduce the patent-protected marketing period for the company's product candidates[126] - Noncompliance with patent maintenance requirements could result in the loss of patent rights, enabling competitors to enter the market[127] - Changes in U.S. patent law, including recent Supreme Court rulings, could diminish the value of the company's patents and weaken its ability to enforce them[130] - Limited intellectual property rights outside the U.S. may hinder the company's ability to prevent competitors from using its technologies in foreign jurisdictions[131] - Enforcement of patent rights in foreign jurisdictions, particularly in China and developing countries, could be costly and ineffective[132] Equity and Stock Information - The company's common stock had 307 record holders as of January 8, 2025, with a closing price of $2.25 per share[159] - Equity compensation plans approved by security holders include 11,171,094 securities to be issued with a weighted average exercise price of $3.74[161] - The company has issued 13,488,062 shares of common stock with a weighted average exercise price of $3.53, and has the authority to issue an additional 645,000 shares annually, which may dilute stockholders' ownership and exert downward pressure on the stock price[141] - The company's common stock trades under the symbol "ANIX" on the NASDAQ Capital Market[158] - The 2018 Share Incentive Plan allows for the issuance of up to 5,000,000 shares initially, with an annual replenishment of 2,000,000 shares starting January 2019[163] - The 2018 Share Incentive Plan provides for various equity-based awards, including stock options and performance awards, and is administered by the Compensation Committee[163] - Future issuance or sale of shares, including an at-the-market equity offering of up to $97 million, could dilute ownership and reduce the market price of the company's common stock[133] - Fluctuations in quarterly operating results, driven by clinical trial progress and regulatory developments, could cause volatility in the company's stock price[137] - Weighted average fair value of stock options granted in 2024 is $2.94, compared to $3.29 in 2023[275] - Expected volatility for stock options decreased to 76.48% in 2024 from 100.27% in 2023[275] - Risk-free interest rate remained constant at 3.87% for both 2024 and 2023[275] - Excluded from Diluted EPS calculation for 2024 are options to purchase 12,158,062 shares and warrants to purchase 300,000 shares[278] Regulatory and Compliance Risks - The company faces risks of failing to enroll sufficient patients, meet clinical trial endpoints, or secure necessary materials for trials[74] - The company relies on strategic collaborations for manufacturing and commercialization but faces challenges in timing and establishing partnerships[75] - The company's product candidates, including CAR-T therapies and cancer vaccines, face significant development and regulatory challenges[83][84] - The company may incur substantial liabilities from product liability lawsuits, potentially limiting commercialization[76] - The company's biotechnology and pharmaceutical products are in early stages, with no revenue generated and significant uncertainty regarding profitability[79] - The company relies on third parties, including universities and medical institutions, to conduct pre-clinical studies and clinical trials, which may lead to delays and increased costs[88] - Failure to comply with cGCP regulations by third parties could result in unreliable clinical data and require additional trials, delaying regulatory approval[88] - Switching or adding third parties for clinical trials involves substantial costs and can cause delays, impacting development timelines[90] - The company is responsible for ensuring clinical trials comply with legal, regulatory, and scientific standards, despite reliance on third parties[88] - The company faces challenges in obtaining regulatory approval for T cell therapies due to limited regulatory experience with such treatments[87] - Establishing sales and marketing capabilities is crucial for gaining market acceptance of novel therapies post-regulatory approval[87] - The FDA regulatory approval process for the company's product candidates is lengthy, uncertain, and costly, with potential delays due to the novel nature of T cell therapies and cancer vaccines[107] - Clinical trial delays may occur due to financial constraints, patient recruitment challenges, site deviations, or manufacturing issues, which could harm the company's business prospects and delay revenue generation[108][110] Operational and Strategic Risks - The company's subsidiary, Certainty, holds a 4.4% equity stake in Wistar as of October 31, 2024, due to dilution from company funding[16] - The company does not expect to generate revenue from its vaccine or therapeutics programs in the near term and aims to license technologies to large pharmaceutical companies[27] - The company leases 2,000 square feet of office space in San Jose, California, with a base rent of approximately $5,000 per month and an option to extend the lease until September 30, 2029[153] - The company has not experienced any cybersecurity threats that have materially affected its operations[148] - The company is a smaller reporting company (SRC) and may remain so until its market value exceeds $250 million or it achieves over $100 million in annual revenues with a market value exceeding $700 million[143] - The company's operating lease liability as of October 31, 2024, has a present value of $232,000, with future minimum lease payments totaling $312,000 over the next five years[299] - The company has committed approximately $150,000 under technology license agreements for therapeutic and vaccine development programs over the next twelve months[301] - Future payments under research and development agreements, including for a breast cancer vaccine Phase 2 trial and CAR-T technology development, may total approximately $4.2 million over up to five years[302] - The company has federal tax net operating loss carryforwards of approximately $99.87 million and tax credit carryforwards of $1.95 million as of October 31, 2024[303] - California tax net operating loss carryforwards amount to approximately $60.62 million, expiring between 2025 and 2044[304] - The company's ability to use net operating loss carryforwards may be limited due to potential ownership changes[71] - The company's CAR-T ovarian cancer therapeutic and cancer vaccines are in early development stages, requiring significant resources for FDA approvals[72] - The company faces risks related to reliance on a single or limited number of suppliers for raw materials, which could disrupt production if suppliers go out of business or are acquired by competitors[105] - The company may pursue strategic alliances, joint ventures, or licensing arrangements, but these could lead to increased costs, dilution of stock, or integration challenges, with no guarantee of successful outcomes[106] - The company's investment policy includes diversified financial instruments, such as U.S. government debt securities and Bitcoin Assets, with Bitcoin Assets measured at fair value based on active market prices[260][261] - As of October 31, 2024, the company's financial assets measured at fair value totaled $19.8 million, including $1.2 million in Level 1 cash equivalents and $18.7 million in Level 2 U.S. treasury bills[266] - Research and development expenses for 2024 and 2023 included $4.4 million in stock-based compensation for employees and directors, with $4.8 million in unrecognized compensation costs as of October 31, 2024[272] - The company recorded $125,000 in consulting expenses related to stock options granted to consultants in 2024, with $180,000 in unrecognized consulting expenses as of October 31, 2024[273] - The company uses the Black-Scholes pricing model to estimate the fair value of stock options, with grants during 2024 and 2023 having 5-year and 10-year terms vesting over 12 to 36 months[274] - The company's short-term investments as of October 31, 2024, included $18.7 million in U.S. treasury bills and certificates of deposit, compared to $22.9 million in 2023[268] - FASB issued Accounting Standards Update 2023-07, effective for fiscal years beginning after December 15, 2023, requiring more disaggregated expense information[281] - FASB issued Accounting Standards Update 2023-09, effective for fiscal years beginning after December 15, 2024, requiring disaggregated information about effective tax rate reconciliation[282] - FASB issued Accounting Standards Update 2024-03, effective for fiscal years beginning after December 15, 2026, improving disclosures about expense types[283]

Company Participation in Conference - Anixa Biosciences will participate in the iAccess Alpha Virtual Best Ideas Winter Conference 2024 on December 10th and 11th, 2024 [1] - Dr Amit Kumar, CEO of Anixa, is scheduled to present on December 10th at 2:00 pm Eastern Standard Time [2] - Management will be available for one-on-one meetings with approved qualified investors on December 11th [2] Conference Details - iAccess Alpha hosts virtual investor conferences where presenting companies are recommended by a network of investors [3] - The conference format includes company webcast presentations on day one and one-on-one meetings with company management teams on day two [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 CER-T technology [4] - Anixa's vaccine portfolio includes vaccines developed with Cleveland Clinic to treat and prevent breast cancer and ovarian cancer, as well as additional cancer vaccines targeting lung, colon, and prostate cancers [4] - The company's business model involves partnering with world-renowned research institutions for development and commercialization of emerging technologies [4]

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]