Core Insights - Anixa Biosciences has completed dosing its final patient in the third cohort of a Phase 1 clinical trial for its CAR-T therapy targeting recurrent ovarian cancer, in partnership with Moffitt Cancer Center [1][4] - The third cohort received a dose of one million CAR-positive cells per kilogram, a tenfold increase from the first cohort, with the fourth cohort set to increase the dosage by another factor of three [2][3] 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 [5] - The company is also developing vaccines for breast and ovarian cancer in partnership with Cleveland Clinic, targeting various cancers through innovative immunization strategies [5] Clinical Trial Details - The ongoing trial (NCT05316129) is designed to evaluate the safety and efficacy of the CAR-T therapy in adult women with recurrent ovarian cancer who have not responded to at least two prior therapies [3] - Recent protocol amendments allow eligible patients to receive a second dose without requiring separate IND approvals, expanding the enrollment criteria to include rare ovarian cancer subtypes [4]

Core Viewpoint - Anixa Biosciences' breast cancer vaccine has the potential to revolutionize breast cancer prevention by targeting the disease at its earliest stages, as highlighted in a feature on Fox News' "America Reports" [1][3] Company Overview - Anixa Biosciences, Inc. is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a therapeutic portfolio that includes an ovarian cancer immunotherapy program and vaccines for breast cancer and other malignancies [5] Vaccine Development - The breast cancer vaccine is designed to train the immune system to recognize and eliminate cancerous cells before they develop into invasive tumors, specifically targeting the lactation protein α-lactalbumin, which is expressed in malignant breast cancer cells [2] - The Phase I clinical trial, conducted in collaboration with Cleveland Clinic and funded by a U.S. Department of Defense grant, shows promising progress with over 70% of patients demonstrating protocol-defined immune responses [3] Future Plans - A Phase 2 study in the neoadjuvant setting is planned to begin in 2025, representing a critical milestone in the vaccine's continued development [3]

Core Insights - Anixa Biosciences, Inc. will participate in the 18th Annual European Life Sciences CEO Forum to discuss its innovative cancer therapies [1][2][4] - The company is focusing on its CAR-T therapy for ovarian cancer and a breast cancer vaccine, developed in collaboration with leading research institutions [2][4] Company Overview - Anixa is a clinical-stage biotechnology company dedicated to cancer treatment and prevention [4] - The company’s pipeline includes a novel CAR-T therapy for ovarian cancer and vaccines for breast cancer and other hard-to-treat cancers [4] Event Details - The 18th Annual European Life Sciences CEO Forum will take place on February 26-27, 2025, at the Hilton Zurich Airport Hotel [6] - Mike Catelani, President and CFO, will present at the event and engage in one-on-one meetings with potential partners and investors [3][6]

Core Insights - Anixa Biosciences is focused on pioneering efforts in breast cancer prevention, specifically through the development of a novel vaccine targeting triple-negative breast cancer (TNBC) [1][2][3] Company Overview - Anixa is a clinical-stage biotechnology company dedicated to cancer treatment and prevention, with a therapeutic portfolio that includes an ovarian cancer immunotherapy program in collaboration with Moffitt Cancer Center [5] - The company is developing vaccines in partnership with Cleveland Clinic to address breast cancer and ovarian cancer, as well as other cancers such as lung, colon, and prostate [5] Research and Development - The vaccine under development aims to prevent TNBC by targeting a specific protein found in TNBC cells, which is absent in normal breast tissue, thereby stimulating the immune system to eliminate cancer cells before tumor formation [2][3] - Dr. Amit Kumar emphasized the potential of the vaccine to change the approach to breast cancer treatment, potentially reducing the need for invasive procedures like chemotherapy and surgery in the future [3] Industry Impact - The discussion highlighted the broader implications of Anixa's research on oncology and the critical need for continued innovation in cancer prevention [3]

Core Insights - Anixa Biosciences has made significant progress in developing innovative cancer therapies and vaccines in 2024, while maintaining a strong financial position for future growth [1][8] Financial Performance - The company utilized only $7 million in cash during the 2024 fiscal year, ending with $20 million in cash and investments, ensuring a strong balance sheet for advancing programs [2] - Anixa has a cash runway of over 2.5 years, supported by a clean capital structure free of warrants, preferred stock, and debt [5] Clinical Developments - Positive preliminary Phase 1 data from the breast cancer vaccine trial was presented at the SITC conference, showing a strong safety profile with over 70% of patients exhibiting protocol-defined immune responses [2][6] - The company is expanding its vaccine programs to include prostate, lung, and colon cancers, alongside ongoing collaboration with the National Cancer Institute for the ovarian cancer vaccine [3] - The CAR-T program targeting ovarian cancer has shown promising results, with a patient from the first dose cohort receiving FDA authorization for a second dose and remaining well 21+ months post-treatment [4] Future Goals - Plans for 2025 include completing the Phase 1 trial of the breast cancer vaccine, initiating the Phase 2 trial, and advancing CAR-T clinical trials for additional solid tumors [7] - Continued development of vaccines for ovarian, lung, prostate, and colon cancers is expected, with progress updates throughout the year [7]

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]