Business Context and Reporting Period
Company: Anixa Biosciences, Inc. (NASDAQ: ANIX)
Filing Type: Form 10-K (Annual Report)
Period Ended: October 31, 2025
Business Overview: Anixa is a biotechnology company focused on oncology, developing CAR-T cell therapies (lira-cel for ovarian cancer) and cancer vaccines (breast and ovarian cancer). The company operates as a pre-revenue entity, relying on strategic collaborations with institutions like The Wistar Institute, Moffitt Cancer Center, and Cleveland Clinic. It is classified as a smaller reporting company and non-accelerated filer.
Key Financial Metrics
| Metric | Fiscal Year 2025 | Fiscal Year 2024 |
|---|---|---|
| Revenue | $0 | $0 |
| Net Loss | $(11,028,000) | $(12,698,000) |
| Net Loss Attributable to Common Shareholders | $(10,927,000) | $(12,554,000) |
| Operating Expenses | $11,701,000 | $13,831,000 |
| Research & Development Expenses | $5,071,000 | $6,396,000 |
| General & Administrative Expenses | $6,630,000 | $7,435,000 |
| Interest Income | $673,000 | $1,133,000 |
| Cash, Cash Equivalents & Short-Term Investments | $15,174,000 | $19,924,000 |
| Working Capital | $13,920,000 | $18,862,000 |
| Accumulated Deficit | $(251,677,000) | $(240,750,000) |
Note: All figures in thousands unless otherwise noted. The company reported no revenue in either period.
Material Changes vs. Prior Period
- Expense Reduction: Total operating expenses decreased by approximately $2.13 million (15.4%) year-over-year. This was driven by a $1.33 million decrease in R&D expenses and a $0.81 million decrease in G&A expenses.
- R&D Drivers: The decline in R&D was primarily due to timing fluctuations in manufacturing activities for the breast cancer vaccine ($0.67M) and CAR-T program ($0.41M), as well as reduced stock-based compensation ($0.27M).
- G&A Drivers: G&A reductions were attributed to lower investor relations firm expenses ($0.45M) and decreased director/employee stock option compensation ($0.47M combined).
- Interest Income: Interest income declined by $0.46 million due to lower short-term investment balances and decreased interest rates.
- Liquidity: Cash and short-term investments decreased by approximately $4.75 million, primarily due to operating cash outflows of $7.17 million, partially offset by financing activities.
Guidance, Outlook, and Risks
Management Commentary and Outlook
- Clinical Progress:
- lira-cel (CAR-T): Phase 1 dose-escalation trial for ovarian cancer is ongoing. The fourth dose cohort (30x higher dose) was well-tolerated. Anecdotal efficacy signs include T-cell infiltration and tumor necrosis. One patient survived over two years and received a re-dose in October 2024.
- Breast Cancer Vaccine: Phase 1 trial completed enrollment in June 2025 and all clinical visits in October 2025. Final data presented in December 2025 showed all primary endpoints were met, with immune responses in 74% of subjects. The vaccine was safe and well-tolerated. The company is preparing for a Phase 2 neoadjuvant study.
- Ovarian Cancer Vaccine: Pre-clinical development is being supported by the NCI's PREVENT program at no material cost to Anixa.
- Liquidity: Management believes existing cash and investments ($15.2M) are sufficient to fund operations for at least the next 12 months. The company maintains an at-the-market (ATM) equity offering program with approximately $98.6 million remaining capacity.
Risks and Contingencies
- Capital Needs: The company has a history of losses and will require additional funding to advance clinical trials and commercialize products. Failure to secure funding could force expense reductions or business cessation.
- Development Risks: As a pre-revenue biotech, there is significant uncertainty regarding clinical trial outcomes, regulatory approval, and market acceptance. Most drugs fail to reach commercialization.
- Intellectual Property: The company relies on exclusive licenses from The Wistar Institute and Cleveland Clinic. Termination of these licenses would severely impact operations.
- Stock Volatility: The stock is thinly traded and subject to high volatility. Future equity issuances for funding will result in dilution.
Investor Verification Checklist
- Cash Runway: Verify the sufficiency of the $15.2M cash balance against the projected costs of the upcoming Phase 2 breast cancer vaccine trial and continued lira-cel development.
- Phase 2 Timeline: Confirm the specific timeline and regulatory milestones required to initiate the Phase 2 breast cancer vaccine study following the FDA consultations mentioned.
- License Obligations: Review the specific milestone payment triggers in the license agreements with The Wistar Institute and Cleveland Clinic to assess future cash outflows.
- ATM Utilization: Monitor the usage of the remaining ~$98.6M ATM equity offering capacity and its potential dilutive impact on existing shareholders.
- Noncontrolling Interest: Note the noncontrolling interest of The Wistar Institute (4.1% stake in Certainty Therapeutics) and its impact on net loss attribution.