Business Context and Reporting Period
BioAge Labs, Inc. (Nasdaq: BIOA) is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging. The company utilizes a proprietary platform based on longitudinal human aging datasets to identify drug targets. This Form 10-K covers the fiscal year ended December 31, 2025.
Key operational highlights include:
- Lead Program (BGE-102): A novel, orally available, brain-penetrant NLRP3 inhibitor. In January 2026, the company announced positive interim Phase 1 data showing an 86% median reduction in hsCRP in obese participants with elevated cardiovascular risk.
- APJ Agonists: Development of novel apelin receptor agonists for obesity, including oral and parenteral programs. The company terminated its former lead candidate, azelaprag, in January 2025 due to liver transaminitis but is advancing new APJ candidates.
- Collaborations: Active target discovery collaborations with Eli Lilly and Novartis Pharma AG.
Key Financial Metrics
| Metric (in millions) | 2025 | 2024 |
|---|---|---|
| Collaboration Revenue | $9.0 | $0.0 |
| Total Operating Expenses | $101.8 | $78.2 |
| Net Loss | $(80.6) | $(71.1) |
| Cash, Cash Equivalents, and Marketable Securities | $285.1 | $354.3 |
| Accumulated Deficit | $(333.4) | $(252.8) |
| Term Loan Outstanding | $2.0 | $8.5 |
Note: The company has no product revenue. Revenue is derived solely from collaboration agreements, primarily with Novartis.
Material Changes vs. Prior Period
- Revenue: Collaboration revenue increased from $0 in 2024 to $9.0 million in 2025, driven by the commencement of work under the Novartis collaboration agreement.
- Operating Expenses: Total operating expenses increased 30% to $101.8 million.
- R&D Expenses: Increased 25% to $74.0 million. This was driven by a $14.4 million increase in costs for the BGE-102 program and a $24.3 million increase in "other programs" (Novartis work and APJ development), partially offset by a $26.4 million decrease in azelaprag costs following its termination.
- G&A Expenses: Increased 45% to $27.8 million, primarily due to higher stock-based compensation, legal fees, and insurance costs associated with public company status.
- Liquidity: Cash and marketable securities decreased by approximately $69 million year-over-year, primarily due to net cash used in operating activities ($81.6 million) and investing activities ($95.2 million for purchase of marketable securities), partially offset by financing activities ($11.5 million).
Guidance, Outlook, and Risks
Outlook and Milestones
- BGE-102: Full Phase 1 SAD/MAD results are expected in the first half of 2026. A Phase 2a proof-of-concept trial for cardiovascular risk is planned for initiation in the first half of 2026, with results expected by year-end 2026. A Phase 1b/2a trial for Diabetic Macular Edema (DME) is planned for mid-2026.
- APJ Programs: The company intends to file the first Investigational New Drug (IND) application for an APJ program by the end of 2026.
- Capital Resources: Management estimates that existing cash, cash equivalents, and marketable securities ($285.1 million as of Dec 31, 2025) are sufficient to fund operations through 2029.
Risks and Contingencies
- Development Risk: The company has no approved products and relies on the success of BGE-102 and APJ programs. Clinical trial outcomes are uncertain, and the company previously terminated azelaprag due to safety signals.
- Profitability: The company has incurred significant losses since inception and expects to continue incurring losses for the foreseeable future.
- Legal Proceedings: A securities class action complaint filed in January 2025 regarding azelaprag was dismissed with prejudice by the court on March 2, 2026. The plaintiff has 30 days to appeal.
- Debt: A term loan of $2.0 million matures on April 1, 2026.
Investor Verification Checklist
- Verify the timeline and enrollment status of the upcoming Phase 2a cardiovascular risk trial for BGE-102.
- Confirm the specific safety profile and dosing regimen for the new APJ agonist candidates replacing azelaprag.
- Monitor the status of the appeal regarding the dismissed securities class action lawsuit.
- Review the terms of the Novartis collaboration agreement to understand future milestone payment triggers.
- Assess the company's cash burn rate relative to the stated runway through 2029.