Positive interim Phase 1 data for BGE-102, a potent, structurally novel, orally available, brain-penetrant small-molecule NLRP3 inhibitor, demonstrating potential best-in-class reductions in inflammatory biomarkers of cardiovascular risk; Phase 2a proof-of-concept trial planned to initiate in 1H 2026
Indication expansion for BGE-102 into ophthalmology; Phase 1b/2a proof-of-concept trial in diabetic macular edema planned to initiate mid-2026
Completed upsized follow-on public offering of
"The past few months have been a defining period for BioAge as we delivered positive interim Phase 1 data for BGE-102 demonstrating potential best-in-class reductions in inflammatory biomarkers of cardiovascular risk, including hsCRP, IL-6, and fibrinogen," said
Business Highlights
NLRP3 inhibitor clinical development
- In
December 2025 , BioAge announced positive interim data from the ongoing Phase 1 single ascending dose (SAD) / multiple ascending dose (MAD) trial of BGE-102, its oral, brain-penetrant NLRP3 inhibitor. BGE-102 was well tolerated across all doses, with dose-proportional pharmacokinetics supporting once-daily dosing, 90–98% suppression of IL-1ß in an ex vivo whole blood assay at Day 14, and cerebrospinal fluid concentrations exceeding the IC90 at doses of 60 mg and above — a key differentiator from other NLRP3 inhibitors in development. The Company expanded the trial to include MAD cohorts in participants with obesity and elevated hsCRP. - In
January 2026 , BioAge announced additional positive interim Phase 1 data from the first MAD cohort in participants with obesity and elevated hsCRP. At Day 14, BGE-102 120 mg once daily achieved an 86% median reduction in hsCRP, with 93% of participants reaching levels below 2 mg/L, a threshold for reduced cardiovascular risk. - BGE-102 also achieved a 58% reduction in IL-6 and a 30% reduction in fibrinogen.
- Full Phase 1 data are anticipated in the first half of 2026.
- The Company plans to initiate a Phase 2a proof-of-concept trial in cardiovascular risk in the first half of 2026. The trial has been expanded to incorporate dose-ranging, with the goal of potentially enabling initiation of a Phase 3 registration study by the end of 2027. Phase 2a data are expected in the second half of 2026.
BGE-102 indication expansion into ophthalmology
- BioAge announced the expansion of its BGE-102 development program into ophthalmology, with an initial proof-of-concept study planned in patients with diabetic macular edema (DME). NLRP3 inflammasome activation is a central pathological feature in a range of retinal diseases. In preclinical models, oral BGE-102 demonstrated dose-dependent preservation of retinal vascular integrity, achieving near-complete protection from vascular leakage.
- The Company plans to initiate a Phase 1b/2a proof-of-concept trial in patients with DME in mid-2026, with results anticipated in mid-2027. The DME trial will run in parallel with the BGE-102 Phase 2a cardiovascular risk trial.
APJ agonist program advancement
- The Company continued to advance its oral and parenteral APJ agonist development strategy. Under the exclusive option agreement with JiKang Therapeutics announced in
June 2025 , BioAge and JiKang are jointly advancing a novel APJ agonist nanobody demonstrating at least 10-fold greater potency than apelin toward Investigational New Drug (IND)-enabling studies. - In parallel, BioAge is progressing its proprietary portfolio of orally active APJ agonists for which it filed a
U.S. provisional patent application inMay 2025 . - BioAge intends to file the first IND for an APJ program by 2026 year end.
Upsized follow-on public offering
- In
January 2026 , BioAge completed an upsized follow-on public offering of 5,897,435 shares of common stock at a public offering price of$19.50 per share, generating gross proceeds of approximately$115.0 million . InFebruary 2026 , the underwriters exercised their overallotment option in full, purchasing an additional 884,615 shares of common stock at the public offering price, resulting in total gross proceeds from the offering of approximately$132.3 million . The offering was led by Goldman Sachs, Piper Sandler, and Citigroup. The Company estimates that the proceeds from this financing, together with our$285.1 million in cash, cash equivalents, and marketable securities as ofDecember 31, 2025 , will be sufficient to fund operations through 2029 based on its current operating plan.
Strategic partnerships and discovery platform
- BioAge's multi-year research collaboration with Novartis, focused on discovering novel therapeutic targets at the intersection of aging biology and exercise physiology, continued to advance, with multiple targets under evaluation.
- The Company progressed its strategic collaboration with Lilly ExploR&D for the development of therapeutic antibodies targeting novel metabolic aging targets identified through BioAge's discovery platform.
- BioAge continued to advance its initiative to comprehensively profile and analyze samples from the HUNT Biobank in
Norway through its collaboration with Age Labs AS, generating molecular insights from more than 17,000 individual samples tracking the transition from health to disease over decades of lifespan.
Full Year 2025 Financial Results
Collaboration revenue was
Research and development expenses were approximately
General and administrative expenses were
Net loss was
As of
About
BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging. The Company's lead product candidate, BGE-102, is a potent, orally available, brain-penetrant small-molecule NLRP3 inhibitor being developed for cardiovascular risk and retinal diseases. A Phase 1 SAD/MAD trial of BGE-102 is underway, with topline data including additional MAD cohorts anticipated in 1H26. The Company is also developing long-acting injectable and oral small molecule APJ agonists for obesity. BioAge’s additional preclinical programs, which leverage insights from the Company’s proprietary discovery platform built on human longevity data, address key pathways involved in metabolic aging.
Forward-looking statements
This press release contains “forward-looking statements” within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as “aim,” “may,” “will,” “should,” “expect,” “forecast,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. All statements other than statements of historical fact contained in this press release, including without limitation statements regarding our plans to develop and commercialize our product candidates, including BGE-102 and our APJ programs, the potential for BGE-102 as a treatment for atherosclerotic cardiovascular disease risk reduction and diabetic macular edema and the expected timeline for data readouts from our ongoing Phase 1 clinical trial, the timing and results of our ongoing or planned preclinical studies and clinical trials, risks associated with clinical trials, including our ability to adequately manage clinical activities for BGE-102 and our APJ programs, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, the timing of and our ability to obtain and maintain regulatory approvals, the clinical utility of our future product candidates, our commercialization, marketing and manufacturing capabilities and strategy, our expectations about the willingness of healthcare professionals to use our product candidates, the sufficiency of our cash, cash equivalents and marketable securities, general economic conditions, the impact of industry and market conditions on our operations, including fluctuating interest rates and inflation, increased volatility in the debt and equity markets, legislative or regulatory healthcare reforms in
The forward-looking statements in this press release are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including those described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in BioAge’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on
Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. BioAge undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Contacts
PR:
IR:
Partnering: partnering@bioagelabs.com
Web: https://bioagelabs.com
Unaudited Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share information) | ||||||||
| For the Year Ended | ||||||||
| 2025 | 2024 | |||||||
| Collaboration Revenue | $ | 8,995 | $ | — | ||||
| Operating expenses: | ||||||||
| Research and development | 73,966 | 59,036 | ||||||
| General and administrative | 27,809 | 19,158 | ||||||
| Total operating expenses | 101,775 | 78,194 | ||||||
| Loss from operations | (92,780 | ) | (78,194 | ) | ||||
| Other income (expense), net: | ||||||||
| Interest expense | (697 | ) | (2,367 | ) | ||||
| Interest and other income (expense), net | 13,086 | 9,629 | ||||||
| Gain (loss) from changes in fair value of warrants | (214 | ) | 73 | |||||
| Loss on extinguishment of debt | — | (250 | ) | |||||
| Total other income (expense), net | 12,175 | 7,085 | ||||||
| Net loss | $ | (80,605 | ) | $ | (71,109 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | (2.24 | ) | $ | (6.63 | ) | |||
| Weighted-average common shares outstanding, basic and dilutive | 35,932,914 | 10,726,521 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | (80,605 | ) | (71,109 | ) | ||||
| Unrealized holding gains on available-for-sale investments | 122 | — | ||||||
| Foreign currency translation adjustment | (89 | ) | 81 | |||||
| Total other comprehensive income | 33 | 81 | ||||||
| Total comprehensive loss | $ | (80,572 | ) | $ | (71,028 | ) | ||
Unaudited Consolidated Balance Sheets (in thousands, except share and per share information) | ||||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 188,888 | $ | 354,349 | ||||
| Marketable securities, current | 92,210 | — | ||||||
| Accounts receivable | 769 | — | ||||||
| Prepaid expenses and other current assets | 4,926 | 2,754 | ||||||
| Total current assets | 286,793 | 357,103 | ||||||
| Investments | 100 | 100 | ||||||
| Marketable securities | 4,032 | — | ||||||
| Property and equipment, net | 963 | 591 | ||||||
| Operating lease right-of-use assets | 2,785 | 200 | ||||||
| Other assets | 216 | 240 | ||||||
| Total assets | $ | 294,889 | $ | 358,234 | ||||
| Liabilities | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 2,674 | $ | 1,996 | ||||
| Accrued expenses and other current liabilities | 8,480 | 11,751 | ||||||
| Current portion of term loan | 2,648 | 6,000 | ||||||
| Operating lease liabilities, current | 582 | 202 | ||||||
| Deferred revenue, current | 5,754 | 7,826 | ||||||
| Total current liabilities | 20,138 | 27,775 | ||||||
| Deferred revenue | — | 4,674 | ||||||
| Term loan | — | 2,502 | ||||||
| Warrant liability | 370 | 156 | ||||||
| Operating lease liabilities | 2,330 | — | ||||||
| Total liabilities | 22,838 | 35,107 | ||||||
| Commitments and Contingencies (Note 8) | ||||||||
| Stockholders’ Equity | ||||||||
| Preferred stock, outstanding as of | — | — | ||||||
| Common stock, shares issued and outstanding as of 2024, respectively | — | — | ||||||
| Additional paid-in-capital | 605,189 | 575,693 | ||||||
| Accumulated other comprehensive income | 278 | 245 | ||||||
| Accumulated deficit | (333,416 | ) | (252,811 | ) | ||||
| Total stockholders’ equity | 272,051 | 323,127 | ||||||
| Total liabilities and stockholders’ equity | $ | 294,889 | $ | 358,234 | ||||
