ANIX

Anixa Biosciences Inc. (ANIX) - Q1 2026 Filing Summary

Business Context and Reporting Period

This Form 10-Q covers the quarterly period ended January 31, 2026. Anixa Biosciences, Inc. is a biotechnology company focused on developing therapies and vaccines for oncology. Its primary programs include lira-cel (a CAR-T therapy for ovarian cancer) developed by its subsidiary Certainty Therapeutics, and vaccine programs targeting breast and ovarian cancer. The company operates as a non-accelerated filer and smaller reporting company.

Key Financial Metrics

Material Changes vs. Prior Period

• Reduced Net Loss: Net loss attributable to common shareholders decreased by approximately $619,000 (19.4%) compared to Q1 2025, driven by lower operating expenses.
• Expense Reductions:
  • Research & Development (R&D): Decreased by $450,000 to $1.102 million. Reductions were due to timing fluctuations in breast cancer vaccine manufacturing ($189k), CAR-T patient enrollment ($134k), and lower compensation costs.
  • General & Administrative (G&A): Decreased by $220,000 to $1.614 million, primarily due to reduced stock-based compensation ($201k total reduction) and patent prosecution costs.
• Interest Income: Decreased by $42,000 to $131,000 due to lower short-term investment balances and interest rates.
• Capital Raise: The company raised approximately $1.625 million net of expenses through an at-the-market (ATM) equity offering of 429,328 shares during the quarter.

Outlook, Management Commentary, and Risks

• Liquidity: Management believes existing cash, cash equivalents, and short-term investments ($14.2 million) are sufficient to fund operations for at least the next 12 months. The company maintains an ATM program with approximately $98 million remaining capacity.
• Clinical Progress:
  • lira-cel (Ovarian Cancer): Phase 1 dose-escalation trial continues. Thirteen patients treated; seven have survived significantly beyond expected median survival (one patient survived 28 months). Treatment appears well-tolerated across dose cohorts.
  • 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 74% of subjects had protocol-defined immune responses. The company is preparing to initiate a Phase 2 neo-adjuvant trial.
  • Ovarian Cancer Vaccine: Pre-clinical development is supported by the NCI's PREVENT program, requiring no material financial expenditure by the company.
• Risks: The company has no revenue from therapeutics or vaccines and does not expect to generate revenue in the near term. Future profitability depends on licensing technologies to large pharmaceutical companies, which may take several years. There are no material pending legal proceedings other than patent enforcement.

Investor Verification Checklist

• Cash Runway: Verify the $14.2 million liquidity position against the projected burn rate of ~$2.6 million per quarter to confirm the 12-month+ runway assertion.
• Phase 2 Timeline: Confirm the specific timeline and regulatory requirements for initiating the Phase 2 breast cancer vaccine trial following the successful Phase 1 data.
• ATM Utilization: Monitor the remaining $98 million capacity under the at-the-market offering and the frequency of future issuances to assess potential dilution.
• lira-cel Efficacy: Review upcoming data releases regarding the 13 patients treated in the Phase 1 trial to validate the "anecdotal signs of efficacy" and survival statistics.
• Stock-Based Compensation: Note that non-cash stock-based compensation was $796,000 for the quarter; verify the impact of future grants on cash burn versus reported net loss.