Anixa Biosciences, Inc. — FY2022 Form 10-K
Reporting period: Fiscal year ended October 31, 2022; this is an annual filing, not a standalone fourth-quarter report. Anixa is a pre-revenue biotechnology company developing cancer vaccines, ovarian-cancer CAR-T therapy and COVID-19 antiviral candidates.
Financial results and liquidity
| Metric | FY2022 | FY2021 |
|---|---|---|
| Revenue | $0 | $512,000 |
| Research and development | $6.703 million | $6.190 million |
| General and administrative | $7.172 million | $7.073 million |
| Operating loss | $13.875 million | $13.136 million |
| Net loss | $13.771 million | $13.128 million |
| Net loss attributable to common stockholders | $13.595 million; $0.45 per share | $12.954 million; $0.45 per share |
| Cash used in operating activities | $6.492 million | $4.938 million |
At October 31, 2022, cash and cash equivalents were $12.360 million and short-term investments were $17.327 million, totaling $29.687 million, versus $35.727 million a year earlier. Working capital was approximately $28.163 million. Total assets were $30.412 million; total liabilities were $2.212 million, principally lease liabilities. The filing reports no significant off-balance-sheet arrangements and no material debt. No operating margin is presented; with no FY2022 revenue, a revenue-based margin is not meaningful.
Investing activities used $10.728 million in the audited cash-flow statement, mainly reflecting purchases of short-term investments net of maturities. Financing activities provided $452,000, primarily from option exercises. Cash, cash equivalents and short-term investments declined by approximately $6.040 million during the year. Stock-based compensation was $6.655 million, a substantial non-cash portion of reported operating expenses.
Changes and operating developments
- Revenue fell to zero from $512,000 in FY2021, when a one-time technology license payment was recognized. Anixa has generated no revenue from its vaccine or therapeutic programs.
- R&D increased $513,000; G&A increased $99,000. Net loss widened by $643,000, while loss per share remained $0.45.
- The company reached the maximum tolerated dose in its Phase 1 breast-cancer vaccine trial in December 2022 and was expanding the cohort. It expected to present immunological data in Q2 2023.
- Anixa treated the first patient in its ovarian-cancer CAR-T Phase 1 trial in August 2022; recruitment was ongoing. The trial is expected to take two to four years, depending on enrollment and dose-escalation progress.
- The NCI PREVENT program is supporting most preclinical, manufacturing and IND-enabling work on the ovarian-cancer vaccine, with no material company expenditure expected for that work.
- The COVID-19 program remained in discovery and preclinical development. Company-reported animal results and an in-vitro comparison with nirmatrelvir were preliminary; the latter suggested up to fivefold greater inhibition of the viral protease in the assay.
Outlook, risks and contingencies
Management said available cash, short-term investments and expected cash flows should fund activities for at least 12 months from January 4, 2023. It cautioned that actual cash needs may differ and that additional funding may be required. An effective at-the-market program permitted up to $100 million of common-stock sales; no shares were sold under it in FY2022. Future equity or debt financing may be unavailable or dilute shareholders.
Management expects the cancer-vaccine, CAR-T and antiviral programs to remain the company’s focus, but does not expect near-term revenue from them. Its strategy depends on eventual licensing or partnerships, which may take years or never occur. Key risks include clinical safety, efficacy and enrollment uncertainty; reliance on research, clinical and commercial partners; regulatory delays; competition; dependence on licensed intellectual property; and continuing losses and cash consumption. The company reported an accumulated deficit of $218.385 million. It reported no material pending legal proceedings other than actions it brings to enforce patent rights.
The financial statements received an unqualified audit opinion. Management concluded disclosure controls and internal control over financial reporting were effective; the auditor did not attest to internal-control effectiveness under the company’s smaller-reporting-company exemption.
Important facts for investors to verify
- Reconcile investing cash use: the MD&A narrative states approximately $10.278 million, while the audited cash-flow statement reports $10.728 million.
- Track cash runway against operating cash use, trial costs, collaboration commitments and any future financing or share issuance.
- Verify subsequent updates to breast-vaccine immune-response data and CAR-T patient recruitment, safety and trial progress; the cited 2023 expectations are forward-looking statements.
- Assess whether COVID-19 assay and animal findings are independently validated and progress to human-relevant development; they are not evidence of clinical efficacy.
- Review potential dilution from outstanding options, warrants, incentive-plan awards and the available at-the-market offering.