Neumora Therapeutics, Inc. — 2023 Form 10-K
Reporting period: Fiscal year ended December 31, 2023. This is an annual filing; it does not provide standalone fourth-quarter results. Neumora is a clinical-stage biopharmaceutical company with seven neuroscience programs, no approved products, and no product-sale revenue.
Financial performance and position
| Metric | 2023 | 2022 |
|---|---|---|
| Product revenue | None | None |
| Research and development expense | $142.7 million | $91.7 million |
| Acquired in-process R&D expense | $63.9 million | $13.0 million |
| General and administrative expense | $45.5 million | $31.1 million |
| Total operating expenses | $252.1 million | $135.9 million |
| Net loss | $235.9 million | $130.9 million |
| Net loss per share, basic and diluted | $3.63 | $4.81 |
| Net cash used in operating activities | $163.3 million | $114.9 million |
At December 31, 2023, cash and cash equivalents were $374.0 million and marketable securities totaled $89.8 million, for $463.8 million in combined cash, cash equivalents and marketable securities. Total assets were $496.2 million and total liabilities were $27.1 million, including $5.2 million of operating lease liabilities. The balance sheet reports no borrowings or other debt. Current assets were $478.3 million against current liabilities of $25.1 million. Profit margins are not meaningful because the company has no product revenue and is loss-making.
Material changes and notable items
- Net loss increased $105.0 million year over year. Operating expenses rose $116.2 million, chiefly reflecting higher clinical and preclinical spending and acquired IPR&D charges.
- R&D expense increased 56% as navacaprant Phase 3 trials began and activity grew in NMRA-511 and NMRA-266.
- The $63.9 million acquired IPR&D expense included $61.1 million for the navacaprant Phase 3 milestone and $2.8 million related to the Vanderbilt license. The navacaprant milestone was primarily settled with 6.07 million common shares and $2.3 million cash.
- Interest income increased to $16.6 million from $4.6 million, largely reflecting higher cash and investment balances.
- The September 2023 IPO generated $226.5 million in net proceeds. Preferred shares converted to common stock at the IPO; year-end common shares outstanding were 158.8 million.
- Stock-based compensation was $17.2 million, up from $8.3 million. Accumulated deficit was $703.4 million.
Outlook, programs and risks
- Navacaprant: Three Phase 3 KOASTAL efficacy studies and a long-term safety extension were initiated in 2023 for moderate-to-severe MDD. Management anticipated KOASTAL-1 topline results in the second half of 2024, KOASTAL-2 and -3 results in the first half of 2025, and an NDA submission in 2025 if the studies succeed. A Phase 2 bipolar-depression study was planned for the first half of 2024, with results anticipated in 2025.
- NMRA-266: Phase 1 SAD/MAD study began in 2023; data were expected in mid-2024, with a Phase 1b schizophrenia study planned for the second half of 2024.
- Liquidity: Management said year-end cash, cash equivalents and marketable securities were expected to fund operations and capital needs for at least 12 months after the financial statements were issued. The company expects losses and spending to rise and says additional financing will be needed; funding may be unavailable or dilutive.
- Key risks: Clinical and regulatory outcomes remain uncertain; the Phase 3 program is a major execution and spending commitment. Neumora has no commercial revenue, depends on third-party manufacturers and service providers, and has single-source suppliers for certain clinical materials. Licenses and acquisitions also entail contingent milestones, royalties and potential dilution.
- Potential future obligations include up to $915 million of BlackThorn development/regulatory and sales milestones across navacaprant and NMRA-511, and up to $422.4 million of Vanderbilt development and commercial milestones. These amounts are contingent, not current debt; the filing says other milestones had not been achieved at year-end.
- The Phase 2 navacaprant trial’s total efficacy population did not meet its Week 8 primary endpoint (HAMD-17 LSMD -1.7; p=0.121). A prespecified moderate-to-severe subgroup analysis (n=100) showed statistically significant treatment differences, which underpins the Phase 3 focus and merits scrutiny.
- No material legal proceedings were reported. Management reported disclosure controls were effective; the filing did not include management’s internal-control assessment or an auditor attestation, citing the newly public company transition period.
Important facts for investors to verify
- Whether KOASTAL trials meet their endpoints and whether the planned timing and potential 2025 NDA filing remain achievable.
- The full Phase 2 navacaprant results, including subgroup definitions, effect sizes, missing-data methods and safety findings—not only the favorable subgroup analysis.
- Updated cash runway and burn rate as Phase 3 costs progress, along with financing needs and any resulting dilution.
- Milestone and royalty terms, settlement choices and possible share issuance under acquisition and license agreements.
- Clinical progress and safety updates for NMRA-266 and NMRA-511, including the reported prior partial clinical hold for NMRA-511 related to CNS observations.