Final Clinical Visit Marks Major Milestone in First-in-Human Evaluation of Breast Cancer Vaccine Comprehensive Immune Response and Safety Data to Be Presented at the San Antonio Breast Cancer Symposium in December , /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced the completion of the final patient visit in its breast cancer vaccine clinical trial. This novel vaccine, invented at Cle ...

Core Insights - Anixa Biosciences has announced the final results of its Phase 1 clinical trial for a breast cancer vaccine, which will be presented at the 2025 San Antonio Breast Cancer Symposium [1][2][3] - The trial, funded by the U.S. Department of Defense, evaluated the safety and immunogenicity of an alpha-lactalbumin (aLA) vaccine for breast cancer [2][3] - The results are expected to inform discussions with the FDA and advance plans for Phase 2 development [1][3] Company Overview - Anixa Biosciences 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’s vaccine technologies target "retired" proteins expressed in certain cancers, including breast and ovarian cancer, developed at Cleveland Clinic and exclusively licensed to Anixa [4] - Anixa's business model involves partnerships with leading research institutions to explore emerging technologies for further development and commercialization [4]

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[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements.](index=4&type=section&id=Item%201.%20Financial%20Statements.) This section presents Anixa Biosciences' unaudited consolidated financial statements and notes for Q3 2025 and FY2024 Condensed Consolidated Balance Sheets (Unaudited) (in thousands) | Item | July 31, 2025 | October 31, 2024 | | :-------------------------------- | :------------ | :--------------- | | **ASSETS** | | | | Cash and cash equivalents | $1,495 | $1,271 | | Short-term investments | $14,534 | $18,653 | | Total current assets | $17,449 | $21,362 | | Total assets | $17,651 | $21,591 | | **LIABILITIES AND EQUITY** | | | | Total current liabilities | $2,066 | $2,500 | | Total liabilities | $2,240 | $2,703 | | Total shareholders' equity | $16,595 | $19,998 | | Total equity | $15,411 | $18,888 | - Total assets decreased from **$21,591 thousand** as of October 31, 2024, to **$17,651 thousand** as of July 31, 2025, a reduction of approximately **18.2%**[13](index=13&type=chunk) - Total equity decreased from **$18,888 thousand** as of October 31, 2024, to **$15,411 thousand** as of July 31, 2025, a reduction of approximately **18.4%**[13](index=13&type=chunk) Condensed Consolidated Statements of Operations (Unaudited) (in thousands, except per share data) | Item | 3 Months Ended July 31, 2025 | 3 Months Ended July 31, 2024 | 9 Months Ended July 31, 2025 | 9 Months Ended July 31, 2024 | | :------------------------------------------------ | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Revenue | $0 | $0 | $0 | $0 | | Research and development expenses | $1,055 | $1,925 | $3,929 | $4,920 | | General and administrative expenses | $1,381 | $1,667 | $4,896 | $5,748 | | Total operating expenses | $2,436 | $3,592 | $8,825 | $10,668 | | Loss from operations | $(2,436) | $(3,592) | $(8,825) | $(10,668) | | Interest income | $156 | $277 | $519 | $883 | | Net loss | $(2,280) | $(3,315) | $(8,306) | $(9,785) | | Net loss attributable to common shareholders | $(2,258) | $(3,277) | $(8,232) | $(9,671) | | Basic and diluted net loss per common share | $(0.07) | $(0.10) | $(0.25) | $(0.30) | - The company reported no revenue for both the three and nine months ended July 31, 2025 and 2024[15](index=15&type=chunk) - Net loss attributable to common shareholders decreased by approximately **31.1%** for the three months ended July 31, 2025, to **$(2,258) thousand** from **$(3,277) thousand** in the prior year period. For the nine months, it decreased by approximately **14.9%** to **$(8,232) thousand** from **$(9,671) thousand**[15](index=15&type=chunk) Condensed Consolidated Statements of Equity (Unaudited) - Three Months Changes in Total Equity (in thousands) for the Three Months Ended July 31 | Item | 2025 | 2024 | | :------------------------------------------------ | :----- | :----- | | Balance, April 30 | $14,906 | $22,581 | | Stock option compensation to employees and directors | $829 | $1,094 | | Common stock issued in at-the-market offering, net | $1,928 | $(45) | | Net loss | $(2,280) | $(3,315) | | Balance, July 31 | $15,411 | $20,691 | - Total equity decreased from **$20,691 thousand** as of July 31, 2024, to **$15,411 thousand** as of July 31, 2025, for the three-month period[18](index=18&type=chunk)[20](index=20&type=chunk) - The company issued **596,974 shares** of common stock in an at-the-market offering, generating **$1,928 thousand** net of expenses, during the three months ended July 31, 2025[18](index=18&type=chunk) Condensed Consolidated Statements of Equity (Unaudited) - Nine Months Changes in Total Equity (in thousands) for the Nine Months Ended July 31 | Item | 2025 | 2024 | | :------------------------------------------------ | :----- | :----- | | Balance, October 31 | $18,888 | $23,371 | | Stock option compensation to employees and directors | $2,822 | $3,440 | | Common stock issued in at-the-market offering, net | $1,924 | $2,984 | | Net loss | $(8,306) | $(9,785) | | Balance, July 31 | $15,411 | $20,691 | - Total equity decreased from **$20,691 thousand** as of July 31, 2024, to **$15,411 thousand** as of July 31, 2025, for the nine-month period[22](index=22&type=chunk)[24](index=24&type=chunk) - The company issued **611,686 shares** of common stock in an at-the-market offering, generating **$1,924 thousand** net of expenses, during the nine months ended July 31, 2025[22](index=22&type=chunk) Condensed Consolidated Statements of Cash Flows (Unaudited) Condensed Consolidated Statements of Cash Flows (Unaudited) (in thousands) for the Nine Months Ended July 31 | Cash Flow Activity | 2025 | 2024 | | :------------------------------------ | :----- | :----- | | Net cash used in operating activities | $(5,918) | $(6,408) | | Net cash provided by investing activities | $4,212 | $3,409 | | Net cash provided by financing activities | $1,930 | $3,309 | | Net increase in cash and cash equivalents | $224 | $310 | | Cash and cash equivalents at end of period | $1,495 | $1,225 | - Net cash used in operating activities decreased by approximately **7.6%** to **$(5,918) thousand** for the nine months ended July 31, 2025, compared to **$(6,408) thousand** in the prior year[26](index=26&type=chunk) - Net cash provided by investing activities increased by approximately **23.6%** to **$4,212 thousand** for the nine months ended July 31, 2025, primarily due to proceeds from maturities of short-term investments[26](index=26&type=chunk) [Notes to Condensed Consolidated Financial Statements (Unaudited)](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) [1. BUSINESS AND FUNDING](index=10&type=section&id=1.%20BUSINESS%20AND%20FUNDING) Anixa Biosciences develops oncology therapies and vaccines, leveraging collaborations and existing capital for funding - Anixa Biosciences is a biotechnology company developing therapies and vaccines for oncology, including CAR-T cell therapy for ovarian cancer and vaccines for breast and ovarian cancers[29](index=29&type=chunk) - The CAR-T therapy for ovarian cancer is in a Phase 1 dose-escalation clinical trial, with patients in the fourth dose cohort (30x higher dose) showing well-tolerated treatment as of September 2025. Anecdotal signs of efficacy, including T cell infiltration and tumor necrosis, have been observed[31](index=31&type=chunk)[32](index=32&type=chunk)[33](index=33&type=chunk) - The breast cancer vaccine is in a fully enrolled Phase 1 clinical trial (funded by a U.S. Department of Defense grant), with antigen-specific immune responses observed across all dose levels and patient groups (early-stage TNBC, high-risk BRCA/PALB2 mutation carriers, and post-operative TNBC with residual disease). Final Phase 1 data is anticipated in December 2025, with preparations for a Phase 2 trial underway[35](index=35&type=chunk) - The ovarian cancer vaccine technology has been accepted into the NCI's PREVENT program, which will fund and perform virtually all pre-clinical R&D, manufacturing, and IND-enabling studies without material financial expenditures by Anixa[37](index=37&type=chunk) - The company believes existing cash, cash equivalents, and short-term investments of approximately **$16,029,000** as of July 31, 2025, are sufficient to fund activities for significantly longer than 12 months[41](index=41&type=chunk) [2. SIGNIFICANT ACCOUNTING POLICIES](index=13&type=section&id=2.%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This section details the company's significant accounting policies for financial statements, revenue, R&D, and investments - Noncontrolling interest represents Wistar's **4.1%** equity ownership in Certainty Therapeutics as of July 31, 2025, and is presented as a component of equity[30](index=30&type=chunk)[43](index=43&type=chunk) - Revenue is derived solely from technology licensing and patent sales, recognized upon transfer of control of intellectual property rights. No revenue has been generated from vaccine or therapeutics programs to date[40](index=40&type=chunk)[44](index=44&type=chunk) - Research and development expenses are recognized as incurred, including employee compensation and payments to third parties for R&D activities, preclinical studies, and clinical trials[48](index=48&type=chunk) - The investment policy allows for U.S. government debt securities (held-to-maturity at amortized cost) and Bitcoin Assets (measured at fair value with changes recognized in the statement of operations)[51](index=51&type=chunk)[52](index=52&type=chunk) [3. STOCK-BASED COMPENSATION](index=14&type=section&id=3.%20STOCK-BASED%20COMPENSATION) This section details the company's stock-based compensation, covering equity plans, options, warrants, and accounting methods Stock-Based Compensation Expense (in thousands) | Period | Employees & Directors | Consultants | Total | | :--------------------------- | :-------------------- | :---------- | :---- | | 3 Months Ended July 31, 2025 | $829 | $26 | $855 | | 3 Months Ended July 31, 2024 | $1,094 | $23 | $1,117 | | 9 Months Ended July 31, 2025 | $2,822 | $77 | $2,899 | | 9 Months Ended July 31, 2024 | $3,440 | $101 | $3,541 | - For the nine months ended July 31, 2025, **1,430,000 stock options** were granted to employees and consultants, with exercise prices ranging from **$2.37** to **$3.07** per share[56](index=56&type=chunk) - As of July 31, 2025, there were **12,476,094 options** outstanding under the 2018 Share Plan and **986,283 options** outstanding under the 2010 Share Plan[59](index=59&type=chunk)[60](index=60&type=chunk) - The company had **300,000 warrants** outstanding as of July 31, 2025, to purchase common stock at **$6.56** per share, expiring March 22, 2026[62](index=62&type=chunk)[63](index=63&type=chunk) [4. FAIR VALUE MEASUREMENTS](index=17&type=section&id=4.%20FAIR%20VALUE%20MEASUREMENTS) This section describes the company's fair value measurements for financial assets and liabilities using a three-level hierarchy Financial Assets Measured at Fair Value (in thousands) as of July 31, 2025 | Item | Level 1 | Level 2 | Level 3 | Total | | :-------------------------- | :------ | :------ | :------ | :------ | | Money market funds | $1,448 | $- | $- | $1,448 | | Bitcoin exchange traded funds | $- | $12 | $- | $12 | | U.S. treasury bills | $- | $14,522 | $- | $14,522 | | Total financial assets | $1,448 | $14,534 | $- | $15,982 | Financial Assets Measured at Fair Value (in thousands) as of October 31, 2024 | Item | Level 1 | Level 2 | Level 3 | Total | | :-------------------------- | :------ | :------ | :------ | :------ | | Money market funds | $1,170 | $- | $- | $1,170 | | U.S. treasury bills | $- | $18,653 | $- | $18,653 | | Total financial assets | $1,170 | $18,653 | $- | $19,823 | - The company's financial assets primarily consist of money market funds (Level 1) and U.S. treasury bills (Level 2), with a small amount in Bitcoin exchange traded funds (Level 2) as of July 31, 2025[70](index=70&type=chunk) [5. ACCRUED EXPENSES](index=18&type=section&id=5.%20ACCRUED%20EXPENSES) This section details accrued expenses, including payroll, royalties, and legal fees, for July 31, 2025, and October 31, 2024 Accrued Expenses (in thousands) | Item | July 31, 2025 | October 31, 2024 | | :------------------------------ | :------------ | :--------------- | | Payroll and related expenses | $865 | $1,126 | | Accrued royalty and contingent legal fees | $626 | $626 | | Accrued other | $260 | $194 | | Total Accrued expenses | $1,751 | $1,946 | - Total accrued expenses decreased by approximately **10%** from **$1,946 thousand** as of October 31, 2024, to **$1,751 thousand** as of July 31, 2025, primarily due to a decrease in payroll and related expenses[72](index=72&type=chunk) [6. NET LOSS PER SHARE OF COMMON STOCK](index=18&type=section&id=6.%20NET%20LOSS%20PER%20SHARE%20OF%20COMMON%20STOCK) This section explains basic and diluted net loss per common share, where diluted equals basic due to anti-dilutive equivalents - Basic and diluted net loss per common share were **$(0.07)** for the three months ended July 31, 2025, and **$(0.25)** for the nine months ended July 31, 2025[15](index=15&type=chunk) - Stock options (**13,462,377 shares**) and warrants (**300,000 shares**) were excluded from the diluted EPS calculation for the nine months ended July 31, 2025, as their inclusion would be anti-dilutive[73](index=73&type=chunk) [7. EFFECT OF RECENTLY ADOPTED AND ISSUED PRONOUNCEMENTS](index=18&type=section&id=7.%20EFFECT%20OF%20RECENTLY%20ADOPTED%20AND%20ISSUED%20PRONOUNCEMENTS) This section discusses recent FASB pronouncements on Segment Reporting, Income Taxes, and Expense Disaggregation, with impact under evaluation - FASB issued ASU 2023-07 (Segment Reporting) effective for fiscal years beginning after December 15, 2023, requiring more disaggregated expense information for reportable segments[74](index=74&type=chunk) - FASB issued ASU 2023-09 (Income Taxes) effective for fiscal years beginning after December 15, 2024, requiring disaggregated effective tax rate reconciliation and income taxes paid information[75](index=75&type=chunk) - FASB issued ASU 2024-03 (Expense Disaggregation Disclosures) effective for fiscal years beginning after December 15, 2026, to improve disclosures about expense types[76](index=76&type=chunk) [8. INCOME TAXES](index=19&type=section&id=8.%20INCOME%20TAXES) This section addresses income tax accounting, deferred tax assets, valuation allowances, and net operating loss carryforward limitations - A full valuation allowance has been provided against deferred tax assets due to historical pre-tax losses and uncertainty of realization[77](index=77&type=chunk) - The company has substantial net operating loss carryforwards for Federal and California income tax returns, which could be subject to limitations under Internal Revenue Code section 382[78](index=78&type=chunk) [9. LEASES](index=19&type=section&id=9.%20LEASES) This section details the company's operating lease for executive offices, expiring September 30, 2027, and future payments - The company leases approximately **2,000 square feet** of office space, with the lease expiring on September 30, 2027, and an option for a two-year extension[79](index=79&type=chunk) Annual Minimum Future Lease Payments (in thousands) as of July 31, 2025 | For Years Ended October 31, | Operating Leases | | :-------------------------- | :--------------- | | 2025 (remaining) | $15 | | 2026 | $63 | | 2027 | $64 | | 2028 | $66 | | 2029 | $63 | | Total future minimum lease payments, undiscounted | $271 | | Present value of future minimum lease payments | $213 | [10. COMMITMENTS AND CONTINGENCES](index=20&type=section&id=10.%20COMMITMENTS%20AND%20CONTINGENCES) This section outlines commitments and contingencies, including legal proceedings, license, and R&D agreement payments - The company is not a party to any material pending legal proceedings, other than patent enforcement lawsuits[82](index=82&type=chunk) - As of July 31, 2025, license commitments for the next twelve months were approximately **$150,000**[83](index=83&type=chunk) - Future payments under research & development agreements may be approximately **$1.8 million** over up to a three-year period, dependent on development milestones[84](index=84&type=chunk) [11. SEGMENT INFORMATION](index=20&type=section&id=11.%20SEGMENT%20INFORMATION) This section provides financial information for Cancer Vaccines, CAR-T Therapeutics, and Other segments, including net loss and assets Net Loss by Segment (in thousands) for the Nine Months Ended July 31 | Segment | 2025 | 2024 | | :----------------- | :----- | :----- | | Cancer Vaccines | $(5,195) | $(5,628) | | CAR-T Therapeutics | $(3,074) | $(4,115) | | Other | $(37) | $(42) | | Total | $(8,306) | $(9,785) | Total Assets by Segment (in thousands) | Segment | July 31, 2025 | October 31, 2024 | | :----------------- | :------------ | :--------------- | | Cancer Vaccines | $9,842 | $12,917 | | CAR-T Therapeutics | $7,691 | $8,535 | | Other | $118 | $139 | | Total | $17,651 | $21,591 | - Operating costs and expenses excluding non-cash stock-based compensation decreased across all segments for the nine months ended July 31, 2025, compared to the prior year, with Cancer Vaccines decreasing by **$274 thousand** and CAR-T Therapeutics by **$763 thousand**[85](index=85&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) This section analyzes financial condition, operations, liquidity, capital resources, and critical accounting policies for Q3 2025 and FY2024 [GENERAL](index=22&type=section&id=GENERAL) The company's business description is discussed in the Notes to the Condensed Consolidated Financial Statements - The company's business description is discussed in the Notes to the Condensed Consolidated Financial Statements[88](index=88&type=chunk) [RESULTS OF OPERATIONS](index=22&type=section&id=RESULTS%20OF%20OPERATIONS) [Three months ended July 31, 2025 compared with three months ended July 31, 2024](index=22&type=section&id=Three%20months%20ended%20July%2031%2C%202025%20compared%20with%20three%20months%20ended%20July%2031%2C%202024) [Revenue](index=22&type=section&id=Revenue) The company generated no revenue during the three months ended July 31, 2025 and 2024 - The company generated no revenue during the three months ended July 31, 2025 and 2024[89](index=89&type=chunk) - Revenue from current therapy or vaccine programs is not expected in the near term, with a long-term goal of licensing technologies to large pharmaceutical companies[90](index=90&type=chunk) [Research and Development Expenses](index=22&type=section&id=Research%20and%20Development%20Expenses) Research and Development Expenses (in thousands) | Period | 2025 | 2024 | Change | | :--------------------------- | :----- | :----- | :----- | | 3 Months Ended July 31 | $1,055 | $1,925 | $(870) | | Cancer Vaccines | $615 | $1,259 | $(644) | | CAR-T Therapeutics | $440 | $666 | $(226) | - The decrease in R&D expenses was primarily due to a **$631 thousand** decrease in breast cancer vaccine expenses, a **$170 thousand** decrease in ovarian cancer CAR-T therapeutic expenses, and a **$106 thousand** decrease in employee stock-based compensation[93](index=93&type=chunk) [General and Administrative Expenses](index=23&type=section&id=General%20and%20Administrative%20Expenses) General and Administrative Expenses (in thousands) | Period | 2025 | 2024 | Change | | :--------------------------- | :----- | :----- | :----- | | 3 Months Ended July 31 | $1,381 | $1,667 | $(286) | - The decrease was mainly driven by a **$98 thousand** decrease in director stock-based compensation, a **$94 thousand** decrease in investor and public relations expense, and a **$77 thousand** decrease in employee compensation[94](index=94&type=chunk) [Interest Income](index=23&type=section&id=Interest%20Income) Interest Income (in thousands) | Period | 2025 | 2024 | Change | | :--------------------------- | :----- | :----- | :----- | | 3 Months Ended July 31 | $156 | $277 | $(121) | - The decrease in interest income was primarily due to a lower amount of short-term investments held and a decrease in interest rates[95](index=95&type=chunk) [Net Loss Attributable to Noncontrolling Interest](index=23&type=section&id=Net%20Loss%20Attributable%20to%20Noncontrolling%20Interest) Net Loss Attributable to Noncontrolling Interest (in thousands) | Period | 2025 | 2024 | Change | | :--------------------------- | :----- | :----- | :----- | | 3 Months Ended July 31 | $(22) | $(38) | $16 | - The decrease in net loss attributable to noncontrolling interest was due to a decrease in Certainty's net loss[96](index=96&type=chunk) [Nine months ended July 31, 2025 compared with nine months ended July 31, 2024](index=23&type=section&id=Nine%20months%20ended%20July%2031%2C%202025%20compared%20with%20nine%20months%20ended%20July%2031%2C%202024) [Revenue](index=23&type=section&id=Revenue_9M) The company generated no revenue during the nine months ended July 31, 2025 and 2024 - The company generated no revenue during the nine months ended July 31, 2025 and 2024[97](index=97&type=chunk) - Revenue from current therapy or vaccine programs is not expected in the near term, with a long-term goal of licensing technologies to large pharmaceutical companies[98](index=98&type=chunk) [Research and Development Expenses](index=23&type=section&id=Research%20and%20Development%20Expenses_9M) Research and Development Expenses (in thousands) | Period | 2025 | 2024 | Change | | :--------------------------- | :----- | :----- | :----- | | 9 Months Ended July 31 | $3,929 | $4,920 | $(991) | | Cancer Vaccines | $2,489 | $2,827 | $(338) | | CAR-T Therapeutics | $1,440 | $2,093 | $(653) | - The decrease in R&D expenses was primarily due to a **$524 thousand** decrease in breast cancer vaccine expenses, a **$402 thousand** decrease in ovarian cancer CAR-T therapeutic expenses, and a **$271 thousand** decrease in employee stock-based compensation[100](index=100&type=chunk) - These decreases were partially offset by a **$113 thousand** increase in expenses for the new vaccine discovery program and a **$56 thousand** increase in technology licensing fees[100](index=100&type=chunk) [General and Administrative Expenses](index=24&type=section&id=General%20and%20Administrative%20Expenses_9M) General and Administrative Expenses (in thousands) | Period | 2025 | 2024 | Change | | :--------------------------- | :----- | :----- | :----- | | 9 Months Ended July 31 | $4,896 | $5,748 | $(852) | - The decrease was mainly due to a **$478 thousand** decrease in investor and public relations expense, a **$280 thousand** decrease in director stock-based compensation, and a **$68 thousand** decrease in employee stock-based compensation[101](index=101&type=chunk) [Interest Income](index=24&type=section&id=Interest%20Income_9M) Interest Income (in thousands) | Period | 2025 | 2024 | Change | | :--------------------------- | :----- | :----- | :----- | | 9 Months Ended July 31 | $519 | $883 | $(364) | - The decrease in interest income was primarily due to a lower amount of short-term investments held and a decrease in interest rates[102](index=102&type=chunk) [Net Loss Attributable to Noncontrolling Interest](index=24&type=section&id=Net%20Loss%20Attributable%20to%20Noncontrolling%20Interest_9M) Net Loss Attributable to Noncontrolling Interest (in thousands) | Period | 2025 | 2024 | Change | | :--------------------------- | :----- | :----- | :----- | | 9 Months Ended July 31 | $(74) | $(114) | $40 | - The decrease in net loss attributable to noncontrolling interest was due to a decrease in Certainty's net loss[103](index=103&type=chunk) [LIQUIDITY AND CAPITAL RESOURCES](index=24&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) This section discusses liquidity from cash and investments, detailing cash flow activities for the nine months ended July 31, 2025 - As of September 10, 2025, the company believes its **$16,029,000** in cash, cash equivalents, and short-term investments (as of July 31, 2025) are sufficient to fund activities for significantly longer than 12 months[41](index=41&type=chunk)[105](index=105&type=chunk) - During the nine months ended July 31, 2025, the company raised approximately **$1,924,000** (net of expenses) through an at-the-market equity offering of **611,686 shares**[41](index=41&type=chunk)[105](index=105&type=chunk) Cash Flow Summary (in thousands) for the Nine Months Ended July 31, 2025 | Activity | Amount | | :------------------------------------ | :----- | | Cash used in operating activities | $(5,918) | | Cash provided by investing activities | $4,212 | | Cash provided by financing activities | $1,930 | | Net decrease in cash, cash equivalents, and short-term investments | $(3,895) | | Cash, cash equivalents, and short-term investments at July 31, 2025 | $16,029 | [CRITICAL ACCOUNTING POLICIES](index=25&type=section&id=CRITICALACCOUNTING%20POLICIES) This section highlights critical accounting policies for revenue, stock-based compensation, and R&D expenses - Critical accounting policies include Revenue Recognition, Stock-Based Compensation, and Research and Development Expenses, which require significant assumptions, judgments, and estimates[107](index=107&type=chunk)[113](index=113&type=chunk) - Revenue from technology licensing and patent sales is recognized upon transfer of control of intellectual property rights, involving judgments on contract existence, performance obligations, and transaction price allocation[108](index=108&type=chunk)[109](index=109&type=chunk)[110](index=110&type=chunk) - Stock-based compensation expense is measured at grant date fair value using the Black-Scholes pricing model or Monte Carlo Simulation, with assumptions for expected term, volatility, risk-free interest rates, and dividend yield[111](index=111&type=chunk)[112](index=112&type=chunk)[114](index=114&type=chunk) - Research and development expenses are recognized as incurred, with estimates for preclinical studies and clinical trial expenses based on services performed and stage of completion[116](index=116&type=chunk)[117](index=117&type=chunk)[118](index=118&type=chunk) [EFFECT OF RECENTLY ISSUED PRONOUNCEMENTS](index=26&type=section&id=EFFECT%20OF%20RECENTLY%20ISSUED%20PRONOUNCEMENTS) - The effect of recently issued pronouncements is discussed in Note 7 of the condensed consolidated financial statements[119](index=119&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.) This section states that there are no applicable quantitative and qualitative disclosures about market risk for the company - The company has no applicable quantitative and qualitative disclosures about market risk[120](index=120&type=chunk) [Item 4. Controls and Procedures.](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management confirmed effective disclosure controls and procedures as of July 31, 2025, with no material internal control changes - Disclosure controls and procedures were evaluated and deemed effective as of July 31, 2025[120](index=120&type=chunk) - No material changes in internal control over financial reporting occurred during the three months ended July 31, 2025[121](index=121&type=chunk) [PART II. OTHER INFORMATION](index=27&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings.](index=27&type=section&id=Item%201.%20Legal%20Proceedings.) The company is not a party to any material legal proceedings, except for patent enforcement lawsuits - The company is not involved in any material pending legal proceedings, other than those related to patent rights enforcement[123](index=123&type=chunk) [Item 1A. Risk Factors.](index=27&type=section&id=Item%201A.%20Risk%20Factors.) No material changes to risk factors have occurred since the Annual Report on Form 10-K for fiscal year ended October 31, 2024 - No material changes to risk factors have occurred since the Annual Report on Form 10-K for the fiscal year ended October 31, 2024[124](index=124&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.) This section reports that there were no unregistered sales of equity securities or use of proceeds during the period - There were no unregistered sales of equity securities or use of proceeds[125](index=125&type=chunk) [Item 3. Defaults Upon Senior Securities.](index=27&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) This section states that there were no defaults upon senior securities during the period - There were no defaults upon senior securities[126](index=126&type=chunk) [Item 4. Mine Safety Disclosures.](index=27&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This section indicates that mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable[126](index=126&type=chunk) [Item 5. Other Information.](index=27&type=section&id=Item%205.%20Other%20Information.) This section reports that there is no other information to disclose - No other information to disclose[125](index=125&type=chunk) [Item 6. Exhibits.](index=27&type=section&id=Item%206.%20Exhibits.) This section lists exhibits filed with Form 10-Q, including CEO/CFO certifications and Inline XBRL documents - Exhibits include certifications from the CEO and CFO (Sections 302 and 1350), and various Inline XBRL documents[125](index=125&type=chunk) [SIGNATURES](index=28&type=section&id=SIGNATURES) This section contains the signatures of the registrant's authorized officers, confirming the filing of the report - The report is signed by Dr. Amit Kumar, Chairman and Chief Executive Officer, and Michael J. Catelani, President, Chief Operating Officer and Chief Financial Officer, on September 10, 2025[129](index=129&type=chunk)

Group 1: Biotechnology Investment Overview - Investing in biotechnology stocks is often seen as speculative due to many companies being in clinical or pre-clinical stages, typically not yet profitable and often pre-revenue [1] - Small-cap biotech stocks, particularly those trading under $5, may present opportunities for long-term returns for patient investors [2] Group 2: Hoth Therapeutics - Hoth Therapeutics (NASDAQ: HOTH) is currently priced at $1.46, down 35% from its 12-month high of $3.80, but has seen a 98% increase in 2025 [2][5] - The company has multiple pre-clinical assets, including an obesity drug candidate, and focuses on high-demand markets such as oncology and weight-loss treatments [3][5] - Hoth's pre-clinical oncology candidate, HT-KIT, has shown over 80% knockdown of KIT expression in laboratory settings, targeting aggressive cancers [4] - Analysts project a price target of $4 for Hoth, indicating a potential upside of 150% from current levels [5] Group 3: Silo Pharma - Silo Pharma (NASDAQ: SILO) is currently priced at $0.65, down 29% in 2025 but has gained over 7% in the last three months due to a joint venture with Hoth Therapeutics [7] - The partnership aims to develop Hoth's HT-VA obesity drug candidate, tapping into a market projected to exceed $100 billion globally [7] - Silo Pharma is also focused on developing novel formulations of traditional and psychedelic therapeutics, with four candidates in pre-clinical stages [8] - The company has launched a cryptocurrency treasury strategy, targeting investments in Bitcoin, Ethereum, and Solana [9] Group 4: Anixa Biosciences - Anixa Biosciences (NASDAQ: ANIX) is priced at $2.98 and is further along in its development, with two of its five drugs in Phase 1 clinical trials [10][11] - The company is developing its candidates through partnerships with notable institutions like the Moffitt Cancer Center and the Cleveland Clinic [12] - Analysts have set a consensus price target of $10 for Anixa, suggesting a potential upside of 197% [12]

Anixa Biosciences FY Conference Summary Company Overview - Anixa Biosciences is a clinical-stage biotech company focused on oncology, specifically breast and ovarian cancer [2][3] - The company has a robust pipeline including a breast cancer vaccine and a CAR-T technology for ovarian cancer, both currently in phase one clinical trials [2][3] Financial Position - Anixa has a strong balance sheet with no debt and over two years of financial runway, holding approximately $16 million in cash and investments [4][3] - The company has maintained a low cash burn rate, averaging between $5 million and $7 million annually, with only $7 million burned in the last fiscal year [4][5] Partnerships and Collaborations - Anixa collaborates with prestigious institutions like Moffitt Cancer Center and Cleveland Clinic, leveraging their infrastructure to minimize costs [3][5] - The company has received grants, including a Department of Defense grant to support the breast cancer vaccine's phase one clinical trial [7][19] Clinical Trials and Product Pipeline CAR-T Therapy for Ovarian Cancer - The CAR-T therapy is designed to target ovarian cancer cells using a unique target, the follicle-stimulating hormone receptor, which is only expressed in ovarian cells [10][11] - The delivery method is intraperitoneal, allowing for localized treatment and potentially reducing systemic side effects [12][13] - As of the latest update, 12 patients have been dosed with no safety issues reported, and some patients have shown extended survival times [14][15] Breast Cancer Vaccine - The breast cancer vaccine targets alpha-lactalbumin, a protein expressed during lactation, which is also found in various breast cancer cells [17][19] - The phase one trial includes three patient groups: recurrence, prevention, and treatment, with over 70% of patients showing effective immune responses [20][21] - The company plans to transition to phase two trials after compiling data from the current phase one trial [21][22] Market Potential - The breast cancer market is significant, with one in eight women expected to experience breast cancer in the U.S. [24] - Anixa aims to leverage its findings to enter larger markets, including primary prevention and recurrence prevention [24][22] Future Directions - Anixa is exploring additional vaccine targets associated with other cancers, including prostate, lung, and colon cancers, in collaboration with Cleveland Clinic [25] - The company has a strong patent portfolio covering multiple aspects of its vaccine and CAR-T programs, with exclusive worldwide licenses from Cleveland Clinic [26] Conclusion - Anixa Biosciences is well-positioned in the oncology space with a strong financial foundation, promising clinical data, and strategic partnerships, aiming to address significant unmet medical needs in cancer treatment [3][4][5]

Company Overview - Anixa Biosciences, Inc. is a clinical-stage biotechnology company focused on cancer treatment and prevention [2] - The company has a therapeutic portfolio that 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) technology [2] - Anixa's vaccine portfolio includes vaccines for breast and ovarian cancer developed in collaboration with Cleveland Clinic, as well as additional vaccines targeting high incidence malignancies in lung, colon, and prostate cancers [2] Upcoming Event - Anixa will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, at 10:30 AM ET [1][2] - The presentation will take place at the Lotte New York Palace Hotel, and Mike Catelani, President and CFO, will be available for one-on-one meetings during the conference [2]

SAN JOSE, Calif., Aug. 25, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that management will participate in the H.C. Wainwright 27th Annual Global Investment Conference being held September 8th – 10th, 2025 at the Lotte New York Palace Hotel in New York City.Mike Catelani, President and CFO of Anixa, will deliver a presentation and will be available for one-on-one meetings du ...

Notice of Allowance marks first Chinese patent to be issued on Anixa Breast Cancer Vaccine Expands global intellectual property coverage in markets with high breast cancer incidence New patent will provide IP protection of Breast Cancer Vaccine in China into at least the 2040s SAN JOSE, Calif., Aug. 20, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that the Chinese National In ...

Core Insights - Anixa Biosciences is conducting a Phase 1 clinical trial for its CAR-T therapy targeting recurrent ovarian cancer, with the second patient in the fourth dose cohort treated successfully [1][3] - The fourth cohort is receiving a dose of three million CAR-positive cells per kilogram, a 30-fold increase from the initial dose, with no dose-limiting toxicities observed to date [2][4] - The CAR-T program targets the follicle-stimulating hormone receptor (FSHR), which is selectively expressed on ovarian cells and certain cancer cells, indicating a potential for targeted therapy [3][4] Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a proprietary CAR-T program developed in collaboration with Moffitt Cancer Center [5] - The CAR-T technology is differentiated by its use of the natural ligand of the FSHR receptor, FSH, which binds directly to tumor cells rather than using an antibody fragment [5] - Anixa's vaccine portfolio includes collaborations with Cleveland Clinic to develop vaccines for breast and ovarian cancer, as well as other cancers, focusing on immunizing against specific proteins expressed in cancer [5]