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].

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements.) The company reported no revenue and a **$6.47 million net loss** for the six months ended April 30, 2024, with **total assets** at **$24.36 million** and **$3.77 million** **cash used in operations** [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) **Total assets** decreased to **$24.36 million** as of April 30, 2024, from **$25.52 million** at October 31, 2023, with **total liabilities** and **equity** also declining Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | April 30, 2024 | October 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $995 | $915 | | Short-term investments | $22,244 | $22,929 | | **Total current assets** | **$24,214** | **$25,356** | | **Total assets** | **$24,355** | **$25,522** | | Total current liabilities | $1,681 | $2,028 | | **Total liabilities** | **$1,774** | **$2,151** | | **Total equity** | **$22,581** | **$23,371** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported no **revenue** for the three and six months ended April 30, 2024, with **net loss** widening to **$3.18 million** for the quarter and **$6.47 million** for the six months due to increased expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended April 30, 2024 | Three Months Ended April 30, 2023 | Six Months Ended April 30, 2024 | Six Months Ended April 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $0 | $210 | $0 | $210 | | Research and development expenses | $1,646 | $998 | $2,995 | $2,066 | | General and administrative expenses | $1,821 | $1,611 | $4,081 | $3,099 | | Loss from operations | ($3,467) | ($2,560) | ($7,076) | ($5,116) | | Net loss | ($3,180) | ($2,307) | ($6,470) | ($4,661) | | Net loss per share (Basic & Diluted) | ($0.10) | ($0.07) | ($0.20) | ($0.15) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) **Net cash used in operating activities** increased to **$3.77 million** for the six months ended April 30, 2024, while investing activities provided **$685,000** and **financing activities** provided **$3.16 million** Cash Flow Summary for the Six Months Ended April 30 (in thousands) | Cash Flow Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($3,765) | ($2,795) | | Net cash provided by (used in) investing activities | $685 | ($4,029) | | Net cash provided by financing activities | $3,160 | $84 | | **Net increase (decrease) in cash** | **$80** | **($6,740)** | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's focus on **oncology vaccines and therapies**, progress in **Phase 1 clinical trials** for breast cancer vaccine and **CAR-T therapy**, a new development agreement with **Cleveland Clinic**, and increased operating costs across its **CAR-T Therapeutics** and **Cancer Vaccines** segments - **Anixa** is a **biotechnology company** focused on developing vaccines and therapies for **oncology**, including a preventative vaccine for **Triple Negative Breast Cancer (TNBC)** and ovarian cancer, and a **CAR-T therapy** for ovarian cancer[23](index=23&type=chunk) - The **Phase 1 clinical trial** for the breast cancer vaccine is ongoing, with patient dosing commenced in **October 2021**, expanding to multiple cohorts[25](index=25&type=chunk) - The **Phase 1 clinical trial** for the **CAR-T therapy** for ovarian cancer is underway, with the first two patients in the second, higher-dose cohort treated in **February and May 2024**[31](index=31&type=chunk) - In **May 2024**, the company entered a **Joint Development and Option Agreement** with **Cleveland Clinic** to develop additional cancer vaccines for high-incidence malignancies[29](index=29&type=chunk)[83](index=83&type=chunk) Segment Net Loss for Six Months Ended April 30 (in thousands) | Segment | 2024 | 2023 | | :--- | :--- | :--- | | CAR-T Therapeutics | ($2,970) | ($1,908) | | Cancer Vaccines | ($3,469) | ($1,871) | | Other | ($31) | ($882) | | **Total** | **($6,470)** | **($4,661)** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management attributes the increased **net loss** to higher **R&D** and **G&A expenses**, driven by advancing **CAR-T** and breast cancer vaccine programs and increased investor relations, while **$23.2 million** in cash and investments are deemed sufficient for the **next twelve months**, supported by a **$3.0 million ATM offering** [Results of Operations](index=21&type=section&id=Results%20of%20Operations) For the six months ended April 30, 2024, the company reported **no revenue**, with **R&D expenses** increasing by **$0.93 million** and **G&A expenses** rising by **$0.98 million**, primarily due to program advancements and investor relations costs - The company had **no revenue** in the three and six months ended April 30, 2024, compared to **$210,000** in prior-year periods from a **one-time license agreement**[88](index=88&type=chunk)[98](index=98&type=chunk) - For the six months ended April 30, 2024, the **$929,000 increase** in **R&D expenses** was primarily due to higher outside research costs for the **CAR-T therapeutics program** (approx. **$407,000**) and the **breast cancer vaccine program** (approx. **$394,000**)[103](index=103&type=chunk) - The **$982,000 increase** in **G&A expenses** for the six-month period was mainly due to a **$579,000 increase** in **investor and public relations expenses**[104](index=104&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) The company believes its **$23.2 million** in cash, **cash equivalents**, and **short-term investments** are sufficient for the **next twelve months**, having raised approximately **$3.0 million**, net of expenses, through an **at-the-market equity offering** - **Management believes** existing cash, **cash equivalents**, and **short-term investments** are sufficient to fund activities for at least the **next twelve months**[109](index=109&type=chunk) - Raised approximately **$3,029,000**, net of expenses, through an **at-the-market equity offering** during the six months ended April 30, 2024[109](index=109&type=chunk)[110](index=110&type=chunk) - Cash, **cash equivalents**, and **short-term investments** decreased by approximately **$605,000** to **$23,239,000** at April 30, 2024, from the end of fiscal year 2023[110](index=110&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) The company's **market risk** is limited to **interest rate risk** on its short-term, fixed-rate, and highly liquid investments, potentially affecting the rate of return upon reinvestment - The company's primary **market risk** is related to changes in **interest rates**, which could affect the rate of return on its short-term, fixed-rate investments at the time of reinvestment[125](index=125&type=chunk) [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management, including the **CEO and CFO**, deemed the company's **disclosure controls and procedures effective** as of April 30, 2024, with no material changes to **internal control over financial reporting** during the quarter - The **CEO and CFO** concluded that the company's **disclosure controls and procedures** are **effective** as of the end of the period covered by the report[126](index=126&type=chunk) - No changes in **internal control over financial reporting** occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[126](index=126&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings.) The company is not a party to any material pending legal proceedings, except for lawsuits related to **patent enforcement** - Other than lawsuits related to **patent enforcement**, the company is not a party to any material pending legal proceedings[127](index=127&type=chunk) [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors.) No material changes have occurred in the company's **risk factors** since its **Annual Report on Form 10-K** for the fiscal year ended **October 31, 2023** - No material changes have occurred in the company's **risk factors** since its last **Annual Report on Form 10-K**[128](index=128&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=27&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) During the six months ended April 30, 2024, the company issued **29,336 shares** of common stock for investor relations services under a **Section 4(a)(2) exemption** - In the six months ended April 30, 2024, the company issued **29,336 shares** of **common stock** as payment for investor relations services[129](index=129&type=chunk)

Core Insights - Anixa Biosciences is advancing its Phase 1 clinical trial for a novel CAR-T therapy targeting ovarian cancer, with treatment for the fifth patient now underway [1][2] - The therapy utilizes a unique approach by targeting the follicle stimulating hormone receptor (FSHR), which is exclusively expressed on ovarian cells, differentiating it from traditional CAR-T therapies [2][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 also has a vaccine portfolio aimed at preventing triple negative breast cancer and ovarian cancer, as well as other cancers, utilizing technologies that target specific proteins expressed in certain cancers [4] Technology Details - The CAR-T technology developed by Anixa is known as chimeric endocrine receptor T-cell (CER-T) therapy, which is an autologous cell therapy targeting FSHR found on granulosa cells of the ovaries [3] - This innovative approach aims to address challenges faced by traditional CAR-T therapies in treating solid tumors, particularly ovarian cancer [2][3]

– Company currently collaborates with Cleveland Clinic on breast cancer and ovarian cancer vaccines – SAN JOSE, Calif., May 8, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, today announced that it has entered into a joint development agreement with Cleveland Clinic to develop novel vaccines for various cancer types. Cleveland Clinic is currently conducting a Phase 1 clinical tr ...

Dr. Amit Kumar interviewed in latest episode, 'The Vaccine That Could End Breast Cancer' SAN JOSE, Calif., May 6, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, today announced a podcast interview of Anixa Chairman and CEO Dr. Amit Kumar by oncologist Dr. Sanjay Juneja, with more than 500,000 followers through his media brand 'TheOncDoc.' The interview is broadly available on po ...

SAN JOSE, Calif., April 30, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, today announced its participation in the Sidoti Micro-Cap Virtual Conference, taking place May 8-9, 2024. Anixa Chairman and CEO Dr. Amit Kumar will present an overview of the Company and its clinical programs including vaccines to prevent cancer and a CAR-T cell therapy to treat cancer.Conference details ...

SAN JOSE, Calif., April 18, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, today announced the appointment of Sanjay Juneja, MD to its Cancer Business Advisory Board. Sanjay Juneja, MD Anixa Chairman and CEO Dr. Amit Kumar stated, "Dr. Juneja is an accomplished medical oncologist who has earned status as a top media personality on cancer prevention and treatment innovations. ...