Positive topline Phase 1 data for BGE-102, demonstrating potential best-in-class reductions among oral NLRP3 inhibitors in inflammatory biomarkers of cardiovascular risk
Phase 2 dose-ranging proof-of-concept trial of BGE-102 in cardiovascular risk planned to initiate in mid-2026, with data anticipated by end of year
Phase 1b/2a proof-of-concept trial of BGE-102 in diabetic macular edema (DME) planned to initiate in mid-2026, with data anticipated in mid-2027
Completed upsized follow-on public offering of
“The positive topline Phase 1 data we reported for BGE-102 in April reinforce our conviction that we have a potential best-in-class NLRP3 inhibitor: a well-tolerated, once-daily oral therapy that could deliver the anti-inflammatory efficacy of injectables," said
First Quarter 2026 Business Highlights
NLRP3 inhibitor clinical development
- In
April 2026 , BioAge reported positive topline data from the Phase 1 trial of BGE-102, its oral, brain-penetrant NLRP3 inhibitor, including a newly announced 60 mg once-daily cohort in participants with obesity and elevated inflammation. - Across both 60 mg and 120 mg once-daily dose levels, BGE-102 achieved rapid and profound reductions in hsCRP, with median reductions of 86% from baseline, together with consistent reductions in IL-6 and fibrinogen.
- At both doses, 87–93% of participants on active treatment reached normalized hsCRP (<2 mg/L) — a threshold associated with reduced cardiovascular risk.
- BGE-102 was well tolerated across all dose levels evaluated. All treatment-emergent adverse events were mild to moderate in severity and self-limited, with no dose dependency. There were no serious adverse events, no treatment-emergent adverse events leading to discontinuation, and no clinically meaningful changes in vital signs, ECGs, or laboratory values.
- Based on the full Phase 1 dataset, the Company plans to initiate a Phase 2 dose-ranging proof-of-concept trial of BGE-102 in participants at elevated cardiovascular risk in mid-2026, with topline data anticipated by year end.
BGE-102 indication expansion into ophthalmology
- In
January 2026 , BioAge announced the expansion of its BGE-102 development program into ophthalmology, with an initial proof-of-concept study planned in patients with DME. - The Company plans to initiate a Phase 1b/2a proof-of-concept trial in mid-2026, with results anticipated in mid-2027.
APJ agonist program advancement
- BioAge continues to advance its oral and injectable APJ agonist development strategy, including a novel APJ agonist antibody that is the subject of an option agreement with JiKang Therapeutics. The Company intends to file its first IND for an APJ program by year-end 2026.
Upsized follow-on public offering
- In
January 2026 , BioAge completed an upsized follow-on public offering, with the underwriters' option to purchase additional shares exercised in full inFebruary 2026 , resulting in total gross proceeds of approximately$132.3 million .
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 also continued to progress its strategic collaboration with Lilly ExploR&D for the development of therapeutic antibodies targeting novel metabolic aging targets.
First Quarter 2026 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 cardiometabolic 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 including diabetic macular edema. BGE-102 has completed a Phase 1 SAD/MAD trial demonstrating a well-tolerated profile and potential best-in-class reductions in hsCRP and other inflammatory biomarkers in participants with obesity and elevated inflammation. Phase 2 cardiovascular risk proof-of-concept data are anticipated by end of year 2026, and Phase 1b/2a diabetic macular edema proof-of-concept data are anticipated in mid-2027. 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, the expected timeline for data readouts from our ongoing Phase 1 clinical trial, the expected 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 Quarterly Report on Form 10-Q 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
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IR:
Partnering: partnering@bioagelabs.com
Web: https://bioagelabs.com
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share information) | ||||||||
| Three Months Ended | ||||||||
| 2026 | 2025 | |||||||
| Collaboration revenue | $ | 2,772 | $ | 1,451 | ||||
| Operating expenses: | ||||||||
| Research and development | $ | 20,410 | $ | 11,109 | ||||
| General and administrative | 7,737 | 6,788 | ||||||
| Total operating expenses | 28,147 | 17,897 | ||||||
| Loss from operations | (25,375 | ) | (16,446 | ) | ||||
| Other income (expense) | ||||||||
| Interest expense | (39 | ) | (255 | ) | ||||
| Interest and other income (expense), net | 3,268 | 3,714 | ||||||
| Gain (loss) from changes in fair value of warrants | (107 | ) | 59 | |||||
| Total other income (expense), net | 3,122 | 3,518 | ||||||
| Net loss | $ | (22,253 | ) | $ | (12,928 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.52 | ) | $ | (0.36 | ) | ||
| Weighted-average common shares outstanding, basic and diluted | 42,480,488 | 35,850,037 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | (22,253 | ) | (12,928 | ) | ||||
| Other comprehensive income (loss): | ||||||||
| Unrealized holding gains (losses) on available-for-sale investments | (178 | ) | 29 | |||||
| Foreign currency translation adjustment | (27 | ) | (10 | ) | ||||
| Total other comprehensive income (loss): | (205 | ) | 19 | |||||
| Total comprehensive loss | $ | (22,458 | ) | $ | (12,909 | ) | ||
Unaudited Condensed Consolidated Balance Sheets (in thousands, except share and per share information) | ||||||||
| 2026 | 2025 | |||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 241,777 | $ | 188,888 | ||||
| Marketable securities, current | 141,417 | 92,210 | ||||||
| Accounts receivable | 709 | 769 | ||||||
| Prepaid expenses and other current assets | 7,957 | 4,926 | ||||||
| Total current assets | 391,860 | 286,793 | ||||||
| Investments | 100 | 100 | ||||||
| Marketable securities | 1,680 | 4,032 | ||||||
| Property and equipment, net | 1,115 | 963 | ||||||
| Operating lease right-of-use assets | 2,684 | 2,785 | ||||||
| Other assets | 215 | 216 | ||||||
| Total assets | $ | 397,654 | $ | 294,889 | ||||
| Liabilities | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 3,066 | $ | 2,674 | ||||
| Accrued expenses and other current liabilities | 4,765 | 8,480 | ||||||
| Current portion of term loan | 1,159 | 2,648 | ||||||
| Operating lease liabilities, current | 646 | 582 | ||||||
| Deferred revenue | 6,191 | 5,754 | ||||||
| Total current liabilities | 15,827 | 20,138 | ||||||
| Warrant liability | 477 | 370 | ||||||
| Operating lease liabilities | 2,229 | 2,330 | ||||||
| Total liabilities | 18,533 | 22,838 | ||||||
| Commitments and Contingencies (Note 7) | ||||||||
| Stockholders’ Equity | ||||||||
| Preferred stock, as of | — | — | ||||||
| Common stock, shares issued and outstanding as of 2025, respectively | — | — | ||||||
| Additional paid-in-capital | 734,717 | 605,189 | ||||||
| Accumulated other comprehensive income | 73 | 278 | ||||||
| Accumulated deficit | (355,669 | ) | (333,416 | ) | ||||
| Total stockholders’ equity | 379,121 | 272,051 | ||||||
| Total liabilities and stockholders’ equity | $ | 397,654 | $ | 294,889 | ||||
