Anixa Biosciences, Inc. — FY2021 Form 10-K
Reporting period: Fiscal year ended October 31, 2021. This is an annual report, not a standalone fourth-quarter filing.
Business context and reporting period
Anixa is a pre-revenue biotechnology company focused on cancer and infectious-disease therapies and vaccines. Its main programs are ovarian-cancer CAR-T therapy, breast- and ovarian-cancer vaccines, and discovery of COVID-19 antiviral candidates. It suspended development of its Cchek cancer-diagnostics platform in July 2020; limited legacy licensing activity continues. The company had five employees at October 31, 2021 and relies on external research and clinical partners.
Financial results and liquidity
| Metric | FY2021 / October 31, 2021 | FY2020 / October 31, 2020 |
|---|---|---|
| Revenue | $512,500 | $0 |
| Operating costs and expenses | $13.65 million | $9.98 million |
| Net loss | $13.13 million | $10.09 million |
| Net loss attributable to common stockholders | $12.95 million | $10.02 million |
| Basic and diluted loss per share | $0.45 | $0.45 |
| Cash, cash equivalents and short-term investments | $35.73 million | $9.06 million |
| Working capital | $34.73 million | Not clearly stated |
| Total assets | $36.26 million | $9.45 million |
| Total liabilities | $1.49 million | $1.19 million |
- The $512,500 of revenue came from one non-recurring license agreement for encrypted audio/video technology; it was not generated by therapeutic or vaccine programs. One licensee accounted for all FY2021 licensing revenue.
- Research and development expense rose 41% to $6.19 million, from $4.38 million. General and administrative expense rose 26% to $7.07 million, from $5.60 million. FY2021 operating costs included $8.06 million of non-cash share-based compensation.
- Operating cash use was $4.94 million, compared with $6.18 million in FY2020. Financing provided $31.57 million, primarily from a $20.29 million public offering and $10.83 million in at-the-market share sales. The ATM program ended June 16, 2021.
- No borrowings are reported. The balance sheet includes operating lease liabilities of approximately $259,000; disclosed undiscounted future lease payments total $331,000. The company also reported approximately $345,000 of collaborative and license commitments for FY2022.
- Management stated on January 4, 2022 that existing cash, investments and expected cash flows were expected to fund activities for at least 12 months, while cautioning that actual cash needs could differ.
Material changes versus the prior comparable period
- Revenue increased from zero, but consisted of a single, non-recurring legacy technology license.
- Net loss increased about 30%, while operating expenses increased about 37%. Increased R&D spending and higher stock-based compensation were important drivers; diagnostics spending fell following the program suspension.
- Cash and short-term investments increased by $26.67 million, chiefly because of equity financing. Common shares outstanding increased from 24.25 million to 30.05 million during the fiscal year.
- Development advanced into clinical testing: FDA authorization for the ovarian-cancer CAR-T Phase 1 trial was received in August 2021, and breast-cancer vaccine Phase 1 dosing began in October 2021.
Outlook, commentary, risks and unusual items
- CAR-T: The Phase 1 dose-escalation trial at Moffitt is designed for 24–48 patients with recurrent epithelial ovarian cancer. The company anticipated treating the first patient in calendar Q1 2022; estimated completion was two to four years, subject to dose finding and recruitment.
- Breast-cancer vaccine: The Cleveland Clinic Phase 1 trial is planned for 18–24 patients at high risk of recurrence; the filing estimated completion in calendar Q3 2022. The program is funded by a U.S. Department of Defense grant.
- Ovarian-cancer vaccine: The NCI PREVENT program was to support preclinical development and IND-enabling work, which the company said would require no material company expenditure.
- COVID-19 antiviral: The company reported preclinical screening, laboratory testing and animal studies, and selected a compound for further chemistry optimization. It reported comparable efficacy to remdesivir in hamster studies and expressed expectations about activity against variants; these are company-reported preclinical findings, not evidence of clinical efficacy. No human clinical results were reported.
- The company does not expect near-term revenue from its therapeutic or vaccine programs and hopes eventually to license technologies to larger pharmaceutical companies. Commercialization, if achieved, may take years and is not assured.
- Principal risks include continuing losses and reliance on future capital, potential dilution, clinical and regulatory failure or delay, patient-enrollment and manufacturing challenges, dependence on collaborators and licensed intellectual property, competition, and disruption from COVID-19. Management reported pandemic-related shutdowns or capacity limits among some service providers and collaborators.
- FY2021 included a $5,000 gain on disposal of property and equipment, compared with a $148,000 loss in FY2020. 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.
Important facts for investors to verify
- Subsequent clinical-trial progress, safety findings, enrollment and timelines for the CAR-T and breast-cancer vaccine programs.
- Whether COVID-19 candidates advance beyond preclinical work, including independent confirmation of potency, safety and variant activity.
- Cash burn and runway relative to management’s 12-month funding estimate, including any new financing, dilution or strategic transactions.
- Future R&D and stock-based compensation expense, and whether any recurring revenue or licensing partnerships emerge.
- Material terms and ongoing obligations under the Wistar, Cleveland Clinic, Moffitt and MolGenie arrangements, and the status of the company’s patent rights.