Anixa Narrows Losses Amidst Clinical Trial Progress

TL;DR

**Anixa's shrinking losses and promising early clinical data make it a speculative buy for long-term biotech believers.**

AI Summary

Anixa Biosciences Inc. reported no revenue for the three and nine months ended July 31, 2025, consistent with the prior year. The company's net loss attributable to common shareholders decreased to $2.258 million for the three months ended July 31, 2025, from $3.277 million in the same period of 2024, representing a 31.1% improvement. For the nine months ended July 31, 2025, the net loss improved to $8.232 million from $9.671 million in 2024, a 14.9% reduction. This improvement was primarily driven by a decrease in operating expenses, with research and development expenses falling to $3.929 million from $4.920 million (a 20.2% decrease) and general and administrative expenses decreasing to $4.896 million from $5.748 million (a 14.8% decrease) for the nine-month period. Cash and cash equivalents increased to $1.495 million as of July 31, 2025, from $1.271 million at October 31, 2024, supported by $1.924 million from an at-the-market offering. The company continues to advance its CAR-T therapy for ovarian cancer, with the fourth dose cohort of its Phase 1 clinical trial showing well-tolerated treatment. Its breast cancer vaccine program has completed enrollment and treatment in its Phase 1 trial, with final data anticipated in December 2025, and preparations for a Phase 2 trial are underway.

Why It Matters

Anixa's reduced net loss and ongoing clinical trial progress, particularly in its CAR-T therapy for ovarian cancer and breast cancer vaccine, are critical for investors. The positive safety data from higher dose cohorts in the ovarian cancer CAR-T trial and the completion of Phase 1 for the breast cancer vaccine suggest potential for future therapeutic breakthroughs, which could significantly impact patient outcomes and market share in oncology. For employees, continued trial success validates their work and secures future development. Customers, specifically cancer patients, stand to benefit from novel treatment options. In a competitive biotech landscape, advancing these programs positions Anixa to potentially challenge established players with innovative immunotherapies and vaccines.

Risk Assessment

Risk Level: high — Anixa Biosciences Inc. is a clinical-stage biotechnology company with no revenue, indicating high reliance on external funding and successful clinical trial outcomes. The company reported an accumulated deficit of $248.982 million as of July 31, 2025, and continues to incur significant losses, with a net loss of $8.306 million for the nine months ended July 31, 2025. This financial position, coupled with the inherent risks of drug development, including potential trial failures and regulatory hurdles, points to a high-risk investment.

Analyst Insight

Investors should monitor Anixa's upcoming final Phase 1 breast cancer vaccine data in December 2025 and subsequent FDA consultations for Phase 2 initiation. Given the high-risk, high-reward nature of clinical-stage biotech, consider a small, speculative position if you believe in the long-term potential of their oncology pipeline, but be prepared for significant volatility.

Financial Highlights

debt To Equity

N/A

revenue

$0

operating Margin

N/A

total Assets

N/A

total Debt

N/A

net Income

$-2.258M

eps

N/A

gross Margin

N/A

cash Position

$1.495M

revenue Growth

0.0%

Revenue Breakdown

Key Numbers

• $0 — Revenue (No revenue for three and nine months ended July 31, 2025 and 2024, indicating pre-commercial stage.)
• $(2.258)M — Net Loss (3 months) (Decreased from $(3.277)M in prior year, a 31.1% improvement.)
• $(8.232)M — Net Loss (9 months) (Decreased from $(9.671)M in prior year, a 14.9% improvement.)
• $3.929M — R&D Expenses (9 months) (Decreased from $4.920M in prior year, a 20.2% reduction.)
• $4.896M — G&A Expenses (9 months) (Decreased from $5.748M in prior year, a 14.8% reduction.)
• $1.495M — Cash and Cash Equivalents (Increased from $1.271M at October 31, 2024, providing short-term liquidity.)
• $1.924M — Proceeds from ATM Offering (Contributed to cash increase, demonstrating access to capital.)
• 32,916,915 — Common Shares Outstanding (As of September 10, 2025, reflecting recent equity offerings.)
• $(248.982)M — Accumulated Deficit (As of July 31, 2025, highlighting historical losses and pre-revenue status.)
• 4.1% — Wistar's Equity Stake in Certainty (Diluted from 5% due to Anixa's funding of Certainty's activities.)

Key Players & Entities

• Anixa Biosciences Inc. (company) — registrant
• Certainty Therapeutics, Inc. (company) — subsidiary developing CAR-T therapy
• The Wistar Institute (company) — licensor of CAR-T intellectual property
• H. Lee Moffitt Cancer Center and Research Institute, Inc. (company) — collaborator for CAR-T clinical testing
• U.S. Food and Drug Administration (regulator) — authorized clinical trials
• The Cleveland Clinic Foundation (company) — licensor of breast and ovarian cancer vaccine technology
• $2.258 million (dollar_amount) — net loss attributable to common shareholders for three months ended July 31, 2025
• $8.232 million (dollar_amount) — net loss attributable to common shareholders for nine months ended July 31, 2025
• $1.924 million (dollar_amount) — proceeds from sale of common stock in an at-the-market offering
• $1.495 million (dollar_amount) — cash and cash equivalents as of July 31, 2025

FAQ

Risk Factors

• Continued Operating Losses and Need for Future Funding [high — financial]: Anixa Biosciences has incurred significant accumulated deficits, totaling $248.982 million as of July 31, 2025. The company has not generated revenue and relies on external financing to fund its operations and clinical development programs. Future funding needs, including potential at-the-market offerings, pose a risk to dilution and financial stability.
• Clinical Trial Risks and Delays [high — operational]: The company's CAR-T therapy for ovarian cancer and breast cancer vaccine program are in clinical trial phases. Delays in trial progression, unexpected adverse events, or failure to demonstrate efficacy could significantly impact development timelines and future commercialization prospects. The final data for the breast cancer vaccine Phase 1 trial is anticipated in December 2025.
• Regulatory Approval Uncertainty [high — regulatory]: The development of novel therapies like CAR-T and cancer vaccines is subject to stringent regulatory review by bodies such as the FDA. Obtaining approval for these therapies is a lengthy and uncertain process, with no guarantee of success. Any setbacks in the regulatory pathway could impede market entry.
• Dependence on Equity Financing [medium — financial]: The company's cash position of $1.495 million as of July 31, 2025, was bolstered by an at-the-market (ATM) offering of $1.924 million. This reliance on equity financing, particularly ATM offerings, can lead to share price dilution and increased cost of capital.
• Limited Operating History and Commercialization Experience [medium — operational]: As a pre-revenue company, Anixa Biosciences lacks a commercial track record. The successful transition from clinical development to commercialization requires significant expertise in manufacturing, marketing, and sales, which the company may need to develop or acquire.
• Wistar Institute Equity Dilution [low — financial]: Anixa's funding of the Wistar Institute's activities has resulted in a dilution of Wistar's equity stake in Certainty from 5% to 4.1%. This indicates a complex financial relationship and potential future implications for equity ownership and collaboration terms.

Industry Context

Anixa Biosciences operates in the highly competitive and innovative biotechnology sector, focusing on oncology. The company is developing novel immunotherapies, including CAR-T and cancer vaccines, which are at the forefront of cancer treatment research. This field is characterized by significant R&D investment, long development cycles, and high regulatory hurdles, with major pharmaceutical companies and numerous smaller biotechs vying for breakthroughs.

Regulatory Implications

The company's drug development programs are subject to rigorous oversight by regulatory agencies like the FDA. Successful navigation of clinical trials and subsequent approval processes are critical. Any delays or failures in meeting regulatory standards could significantly impact Anixa's ability to bring its therapies to market.

What Investors Should Do

1. Monitor clinical trial progress and data releases.
2. Evaluate the company's cash burn rate and future funding strategy.
3. Assess the competitive landscape for Anixa's therapeutic targets.

Key Dates

• 2025-07-31: End of Nine-Month Period — Reporting period for the 10-Q, showing reduced net loss and operating expenses compared to the prior year.
• 2025-10-31: Prior Fiscal Year End — Balance sheet comparison point for cash and cash equivalents.
• 2025-12-01: Anticipated Final Data for Breast Cancer Vaccine Phase 1 — Key milestone for the breast cancer vaccine program, potentially informing Phase 2 trial decisions.

Glossary

At-the-Market (ATM) Offering

A type of public offering where a company sells its stock directly into the open market over a period of time, typically through an intermediary like an investment bank. (Anixa Biosciences utilized an ATM offering to raise $1.924 million, contributing to its cash position and highlighting a method for accessing capital.)

CAR-T Therapy

Chimeric Antigen Receptor T-cell therapy, a type of immunotherapy that uses a patient's own T-cells, genetically engineered to target and kill cancer cells. (Anixa is developing a CAR-T therapy for ovarian cancer, representing a key focus of its research and development efforts.)

Accumulated Deficit

The cumulative net losses of a company that have not been offset by net income or other gains since its inception. (Anixa's substantial accumulated deficit of $248.982 million underscores its pre-revenue status and historical unprofitability.)

Year-Over-Year Comparison

Anixa Biosciences has maintained its pre-revenue status, reporting $0 in revenue for the nine months ended July 31, 2025, consistent with the prior year. However, the company has demonstrated improved financial performance by reducing its net loss by 14.9% to $8.232 million, driven by a 20.2% decrease in R&D expenses and a 14.8% reduction in G&A expenses. Cash reserves have increased to $1.495 million, supported by recent equity financing, indicating a stronger short-term liquidity position compared to the previous fiscal year-end.

Filing Documents

• form10-q.htm (10-Q) — 1211KB
• ex31-1.htm (EX-31.1) — 18KB
• ex31-2.htm (EX-31.2) — 18KB
• ex32-1.htm (EX-32.1) — 7KB
• ex32-2.htm (EX-32.2) — 7KB
• 0001493152-25-013000.txt ( ) — 5202KB
• anix-20250731.xsd (EX-101.SCH) — 31KB
• anix-20250731_cal.xml (EX-101.CAL) — 43KB
• anix-20250731_def.xml (EX-101.DEF) — 151KB
• anix-20250731_lab.xml (EX-101.LAB) — 272KB
• anix-20250731_pre.xml (EX-101.PRE) — 221KB
• form10-q_htm.xml (XML) — 903KB

FINANCIAL INFORMATION

PART I. FINANCIAL INFORMATION

Financial Statements

Item 1. Financial Statements. 1 Condensed Consolidated Balance Sheets (Unaudited) as of July 31, 2025 and October 31, 2024 1 Condensed Consolidated Statements of Operations (Unaudited) for the three and nine months ended July 31, 2025 and 2024 2 Condensed Consolidated Statements of Equity (Unaudited) for the three months ended July 31, 2025 and 2024 3 Condensed Consolidated Statements of Equity (Unaudited) for the nine months ended July 31, 2025 and 2024 4 Condensed Consolidated Statements of Cash Flows (Unaudited) for the nine months ended July 31, 2025 and 2024 5 Notes to Condensed Consolidated Financial Statements (Unaudited) 6

Management's Discussion and Analysis of Financial Condition and Results of Operations

Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations. 17

Quantitative and Qualitative Disclosures About Market Risk

Item 3. Quantitative and Qualitative Disclosures About Market Risk. 21

Controls and Procedures

Item 4. Controls and Procedures. 21

OTHER INFORMATION

PART II. OTHER INFORMATION 22

Legal Proceedings

Item 1. Legal Proceedings. 22

Risk Factors

Item 1A. Risk Factors. 22

Unregistered Sales of Equity Securities and Use of Proceeds

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds. 22

Defaults Upon Senior Securities

Item 3. Defaults Upon Senior Securities. 22

Mine Safety Disclosures

Item 4. Mine Safety Disclosures. 22

Other Information

Item 5. Other Information. 22

Exhibits

Item 6. Exhibits. 22

SIGNATURES

SIGNATURES 23 i PART I. FINANCIAL INFORMATION Item 1. Financial Statements. ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) (in thousands, except share and per share data) July 31, 2025 October 31, 2024 ASSETS Current assets: Cash and cash equivalents $ 1,495 $ 1,271 Short-term investments 14,534 18,653 Receivables - 173 Prepaid expenses and other current assets 1,420 1,265 Total current assets 17,449 21,362 Operating lease right-of-use asset 202 229 Total assets $ 17,651 $ 21,591 LIABILITIES AND EQUITY Current liabilities: Accounts payable $ 276 $ 525 Accrued expenses 1,751 1,946 Operating lease liability, current 39 29 Total current liabilities 2,066 2,500 Operating lease liability, non-current 174 203 Total liabilities 2,240 2,703 Commitments and contingencies (Note 10) - - Equity: Shareholders' equity: Preferred stock, par value $ 100 per share; 19,860 shares authorized; no shares issued or outstanding - - Series A convertible preferred stock, par value $ 100 per share; 140 shares authorized; no shares issued or outstanding - - Preferred stock, value - - Common stock, par value $ .01 per share; 100,000,000 shares authorized; 32,822,109 and 32,196,862 shares issued and outstanding as of July 31, 2025 and October 31, 2024, respectively 328 322 Additional paid-in capital 265,249 260,432 Accumulated deficit ( 248,982 ) ( 240,750 ) Treasury stock, 2,000 shares at cost as of October 31, 2024 - ( 6 ) Total shareholders' equity 16,595 19,998 Noncontrolling interest (Note 2) ( 1,184 ) ( 1,110 ) Total equity 15,411 18,888 Total liabilities and equity $ 17,651 $ 21,591 The accompanying notes are an integral part of these condensed consolidated financial statements. 1 ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (in thousands, except per sha

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