MAIA Biotechnology, Inc. — 2023 Form 10-K
Reporting period: Fiscal year ended December 31, 2023. This is an annual filing, not a standalone fourth-quarter report. MAIA is a clinical-stage oncology biotechnology company with no approved products and no product revenue.
Business context and clinical progress
The company’s lead candidate, THIO (6-thio-dG), is being evaluated in the Phase 2 THIO-101 trial for advanced non-small cell lung cancer (NSCLC), administered before Regeneron’s cemiplimab (Libtayo). The trial is intended to assess safety and efficacy in patients whose disease progressed or did not benefit from prior checkpoint-inhibitor treatment. The FDA cleared the U.S. IND in 2023; trial sites were operating in Australia and Europe.
- In December 2023, MAIA selected 180 mg/cycle as the dose for continued enrollment, citing a better safety profile and stronger efficacy measures than the other tested doses.
- Company-reported updates after year-end said enrollment at 180 mg was completed at 41 patients on February 19, 2024; 79 patients had received one of the three tested doses by the latest cited update.
- A March 2024 interim update cited an overall response rate of 38% (3 of 8 evaluable patients) for 180 mg THIO plus cemiplimab in third-line NSCLC. This is a small, interim efficacy-evaluable group; results may change as data mature.
- Part A safety-lead-in updates reported tolerability at 360 mg/cycle without dose-limiting toxicities or significant treatment-related adverse events. The company also reported encouraging survival and disease-control observations in early patients; these are preliminary, company-reported findings, not established evidence of benefit.
- THIO has received FDA orphan-drug designations for hepatocellular carcinoma, small-cell lung cancer, and malignant glioma. Designation is not marketing approval.
Financial results and liquidity
| Metric | 2023 | 2022 | Change / context |
|---|---|---|---|
| Revenue | None | None | No product commercialization revenue |
| Research and development expense | $11.11 million | $8.93 million | Up 24% |
| General and administrative expense | $9.07 million | $6.14 million | Up 48% |
| Total operating expenses | $20.18 million | $16.18 million | Up 25% |
| Net loss | $19.77 million | $15.77 million | Loss increased 25% |
| Net loss per share, basic and diluted | $1.49 | $1.75 | Weighted-average shares rose to 13.26 million from 9.28 million |
| Net cash used in operating activities | $13.07 million | $12.10 million | Cash use increased |
| Cash at year-end | $7.15 million | $10.95 million | Down $3.80 million |
| Working capital | $2.63 million | $8.54 million | Down $5.91 million |
| Total assets | $7.57 million | $12.02 million | |
| Total liabilities | $7.09 million | $3.51 million | Includes $2.15 million warrant liability |
| Stockholders’ equity | $0.48 million | $8.51 million | Significant decline |
Margins are not meaningful because MAIA had no revenue. The filing reports no conventional funded debt balance in the supplied financial statements; liabilities include accounts payable, accrued expenses, and warrant liabilities. Financing activities provided $9.27 million in 2023, primarily from equity offerings, versus $12.48 million in 2022.
R&D expense rose mainly with clinical-trial startup, preclinical research, payroll/severance, and stock-based compensation. G&A increased primarily from investor-relations costs, directors’ and officers’ insurance, payroll/severance, and stock compensation. The company recorded $0.41 million of net other income, including Australian R&D incentives, interest income, and a gain from the change in fair value of warrant liabilities.
Material changes, outlook, and risks
- Going concern: Management and the auditor state that recurring losses, negative operating cash flows, and the $63.98 million accumulated deficit raise substantial doubt about the company’s ability to continue as a going concern within one year after issuance of the financial statements. Management expects further losses and says additional equity or debt financing is needed; funding is not assured. The audited financial statements were prepared on a going-concern basis.
- Post-year-end financing: By the filing date, MAIA reported approximately $745,000 gross proceeds from its 2024 ATM offering. A private placement closed March 14, 2024, generating approximately $2.92 million gross, including participation by directors, with shares and warrants issued. These financings are subsequent to year-end and do not change the December 31, 2023 cash balance.
- Funding and dilution: The company may need additional capital; equity financing can dilute shareholders, while debt or partnerships may impose restrictions or require rights concessions. Shares outstanding increased from 16.99 million at year-end to 20.00 million as of March 21, 2024.
- Outlook: Management planned to seek early FDA guidance and potentially pursue expedited pathways, including accelerated approval, based on THIO-101 data; it projected seeking U.S. accelerated approval in late 2024 if the clinical evidence supports it. The filing emphasizes that expedited designation or accelerated approval is not assured, and the trial may require design, endpoint, or enrollment changes. Management also planned a Phase 2 study across multiple solid tumors in 2025.
- Development and operating risks: THIO remains investigational; early or interim results may not predict later results. Key risks include safety or efficacy failure, patient enrollment and retention, regulatory requirements (including possible companion-diagnostic needs), reliance on contract manufacturers and CROs, and dependence on licensed intellectual property from UTSW and third parties.
- Exchange listing risk: Year-end stockholders’ equity was approximately $0.48 million, and the company reported losses in each of the three years 2021–2023. MAIA expected a notice from NYSE American regarding equity requirements and could face delisting if it cannot regain compliance.
- Unusual items: 2023 R&D and G&A included accrued severance for terminated officers; the company disclosed $0.82 million accrued severance. A one-time $1.10 million ratchet-share expense occurred in 2022, not 2023. The company approved an $800,000 share-repurchase program in September 2023 but had made no repurchases by year-end.
The auditor issued an unqualified opinion on the financial statements and separately highlighted the going-concern uncertainty. Management concluded disclosure controls and internal control over financial reporting were effective; the auditor did not provide an internal-control attestation.
Most important facts for investors to verify
- Updated, sufficiently mature THIO-101 safety and efficacy results, including response durability, progression-free survival, overall survival, and the full analysis population—not only the interim 3-of-8 response result.
- Cash runway after the 2024 ATM and private placement, expected operating burn, and whether further financing is required and available.
- NYSE American compliance status and any required plan or subsequent exchange notice.
- Potential dilution from outstanding warrants, options, equity plans, and future offerings; confirm current shares outstanding and warrant terms.
- FDA feedback on trial design, expedited pathways, accelerated-approval evidence requirements, and whether a companion diagnostic or further trials will be required.