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. ...

SAN JOSE, Calif., March 14, 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 will host its 2024 Annual Meeting of Stockholders (the "Meeting") on Thursday, March 21, 2024 at 10:00 a.m. Pacific Time in a virtual format. Following the formal business and voting portion of the Meeting, Anixa Chairman and CEO Dr. Amit Kumar will deliver an investor presentation ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended January 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission file number 001-37492 ANIXA BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) | --- | --- | |----------------------- ...

Dose escalation for fourth patient follows successful completion of first cohort SAN JOSE, Calif., Feb. 12, 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 treatment has commenced for the fourth patient in the ongoing Phase 1 clinical trial of its novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer. The study is being conducted through a ...

Conference Investment Track spotlights promising and emerging biotech and healthcare companies advancing the field of oncology SAN JOSE, Calif. , Jan. 29, 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 2024 NeauxCancer Conference organized by the Cancer Advocacy Group of Louisiana (CAGLA), being held February 29 – March 2, 2024 in New Or ...