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BioAge LabsDDocument history
Earnings documents stored for BIOA.
Investor releaseQuarter not tagged2026-08-05BioAge Labs Reports Second Quarter 2026 Financial Results and Provides Business Updates
GlobeNewswire
BioAge Labs Reports Second Quarter 2026 Financial Results and Provides Business Updates
First participant dosed in QUELL-CV, a Phase 2 dose-ranging proof-of-concept trial of BGE-102 measuring inflammatory and cardiometabolic biomarkers; topline data anticipated in the second half of 2026 QUELL-DME, Phase 1b/2a proof-of-concept trial of BGE-102 in diabetic macular edema, planned to initiate in mid-2026, with data anticipated in mid-2027; results expected to support development across inflammation-driven retinal diseases Hosted R&D Day focused on NLRP3 inhibition, featuring Phase 1 data for BGE-102 EMERYVILLE, Calif., Aug. 05, 2026 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. (NASDAQ: BIOA) ("BioAge" or "the Company"), a clinical-stage biopharmaceutical company developing therapeutic product candidates for cardiometabolic diseases by targeting the biology of human aging, today provided business updates and reported its second quarter 2026 financial results. "NLRP3 sits at the apex of the inflammatory cascade that drives a range of diseases," said Kristen Fortney, Ph.D., CEO and co-founder of BioAge. "Our Phase 1 data show that BGE-102 is a potential best-in-class NLRP3 inhibitor: a well-tolerated once-daily pill that delivered up to 98% suppression of IL-1β and brought hsCRP down to normal levels in most participants. We have dosed the first participant in QUELL-CV, our Phase 2 trial in patients with obesity and inflammation at elevated cardiovascular risk, with topline data anticipated in the second half of 2026. We also plan to start a second proof-of-concept trial this year in diabetic macular edema. These studies will test the broad potential of NLRP3 inhibition across inflammasome-driven diseases, and we are actively evaluating additional indications where this mechanism can deliver meaningful benefit. With a strong cash position, we are well positioned to advance BGE-102 across multiple opportunities and continue progressing the broader BioAge pipeline." Second Quarter 2026 Business Highlights BGE-102 clinical development: QUELL-CV Phase 2 trial In June 2026, BioAge announced that the first participant was dosed in QUELL-CV, a Phase 2 dose-ranging proof-of-concept trial of BGE-102, its oral, brain-penetrant NLRP3 inhibitor, measuring inflammatory and cardiometabolic biomarkers. QUELL-CV is a randomized, double-blind, placebo-controlled trial evaluating three once-daily oral doses of BGE-102 (30 mg, 60 mg, and 90 mg) against placebo in approximatel…Read full documentShow less
First participant dosed in QUELL-CV, a Phase 2 dose-ranging proof-of-concept trial of BGE-102 measuring inflammatory and cardiometabolic biomarkers; topline data anticipated in the second half of 2026 QUELL-DME, Phase 1b/2a proof-of-concept trial of BGE-102 in diabetic macular edema, planned to initiate in mid-2026, with data anticipated in mid-2027; results expected to support development across inflammation-driven retinal diseases Hosted R&D Day focused on NLRP3 inhibition, featuring Phase 1 data for BGE-102 EMERYVILLE, Calif., Aug. 05, 2026 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. (NASDAQ: BIOA) ("BioAge" or "the Company"), a clinical-stage biopharmaceutical company developing therapeutic product candidates for cardiometabolic diseases by targeting the biology of human aging, today provided business updates and reported its second quarter 2026 financial results. "NLRP3 sits at the apex of the inflammatory cascade that drives a range of diseases," said Kristen Fortney, Ph.D., CEO and co-founder of BioAge. "Our Phase 1 data show that BGE-102 is a potential best-in-class NLRP3 inhibitor: a well-tolerated once-daily pill that delivered up to 98% suppression of IL-1β and brought hsCRP down to normal levels in most participants. We have dosed the first participant in QUELL-CV, our Phase 2 trial in patients with obesity and inflammation at elevated cardiovascular risk, with topline data anticipated in the second half of 2026. We also plan to start a second proof-of-concept trial this year in diabetic macular edema. These studies will test the broad potential of NLRP3 inhibition across inflammasome-driven diseases, and we are actively evaluating additional indications where this mechanism can deliver meaningful benefit. With a strong cash position, we are well positioned to advance BGE-102 across multiple opportunities and continue progressing the broader BioAge pipeline." Second Quarter 2026 Business Highlights BGE-102 clinical development: QUELL-CV Phase 2 trial In June 2026, BioAge announced that the first participant was dosed in QUELL-CV, a Phase 2 dose-ranging proof-of-concept trial of BGE-102, its oral, brain-penetrant NLRP3 inhibitor, measuring inflammatory and cardiometabolic biomarkers. QUELL-CV is a randomized, double-blind, placebo-controlled trial evaluating three once-daily oral doses of BGE-102 (30 mg, 60 mg, and 90 mg) against placebo in approximately 160 adults with obesity and elevated baseline inflammation. The primary endpoint is percent change from baseline in hsCRP, a pharmacodynamic measure of NLRP3 pathway inhibition, over 12 weeks of dosing. The trial is designed to characterize the dose-response relationship for BGE-102 and to support dose selection for further development, with topline data anticipated in the second half of 2026. QUELL-CV builds on the full Phase 1 dataset for BGE-102, in which the compound achieved up to 98% suppression of IL-1β at trough in an ex vivo whole-blood assay, along with median hsCRP reductions of 86% from baseline at both 60 mg and 120 mg once daily. BGE-102 was well tolerated across all dose levels evaluated, with no serious adverse events, no treatment-emergent adverse events leading to discontinuation, and no clinically meaningful changes in vital signs, ECGs, or laboratory values. BGE-102 clinical development: QUELL-DME Phase 1b/2a trial Following an indication expansion into ocular diseases, the Company plans to initiate QUELL-DME, a Phase 1b/2a proof-of-concept trial of BGE-102 in patients with diabetic macular edema, in mid-2026; results are anticipated in mid-2027. QUELL-DME is designed to demonstrate pharmacodynamic target engagement for BGE-102 in the eye, potentially supporting future development in inflammation-driven retinal diseases. R&D Day on NLRP3 inhibition In May 2026, BioAge hosted an R&D Day featuring Phase 1 clinical data for BGE-102 and the therapeutic rationale for targeting NLRP3 in multiple disease areas driven by inflammasome activation. A recording of the webcast is available at https://ir.bioagelabs.com/news-events/events. 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. 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. Second Quarter 2026 Financial Results Collaboration revenue was $2.4 million for each of the quarters ended June 30, 2026 and 2025. Research and development expenses were $24.4 million for the quarter ended June 30, 2026, compared to $19.8 million for the same period in 2025. The $4.6 million increase in research and development expenses was primarily attributable to a $7.9 million increase in direct costs related to BioAge’s BGE-102 program associated with the initiation of QUELL-CV, start-up costs related to the planned initiation of QUELL-DME, licensing fees, and drug-product manufacturing. The increase was further driven by a $1.5 million increase in personnel-related expenses, primarily reflecting higher stock-based compensation expense associated with new option grants to employees, and a $0.3 million increase in allocated facility and other expenses primarily driven by higher non-program specific consulting fees. These increases were partially offset by a $3.3 million decrease in direct costs for other programs driven by lower licensing costs and a $1.9 million decrease in azelaprag direct costs following termination of its development in January 2025. General and administrative expenses were $7.4 million for the quarter ended June 30, 2026, compared to $7.3 million for the same period in 2025. The $0.1 million increase was primarily driven by a $0.6 million increase in personnel-related expenses, primarily reflecting higher stock-based compensation expense associated with new option grants to employees, executives, board members and advisors, and a $0.1 million increase in corporate insurance expense. These increases were partially offset by a $0.6 million decrease in legal fees. Net loss was $26.1 million for the quarter ended June 30, 2026, or $0.58 per weighted-average common share outstanding, basic and diluted, compared to a net loss of $21.6 million, or $0.60 per weighted-average common share outstanding, basic and diluted, for the same period in 2025. As of June 30, 2026, BioAge had approximately $381.3 million in cash, cash equivalents, and marketable securities. Based on the Company’s current operating plan, BioAge estimates that existing cash, cash equivalents, and marketable securities will be sufficient to fund operations and capital expenses through 2029. About BioAge Labs, Inc. 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 bioavailable, brain-penetrant small-molecule NLRP3 inhibitor being developed for diseases driven by inflammation, including retinal diseases such as 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 inflammatory markers such as hsCRP. Phase 2 proof-of-concept data are anticipated in the second half of 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 diabetic macular edema, the expected timeline for data readouts from our ongoing Phase 2 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 United States, significant political, trade or regulatory developments, including tariffs, federal government shutdowns, or shifting priorities within the U.S. Food and Drug Administration, cybersecurity incidents, and global regional conflicts, and the plans and objectives of management for future operations and capital expenditures are forward-looking statements. 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 August 5, 2026, and BioAge’s other filings with the SEC filed from time to time. 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.ContactsPR: Chris Patil, [email protected] IR: Dov Goldstein, [email protected] Partnering: [email protected] Web: https://bioagelabs.com
Investor releaseQuarter not tagged2026-05-13Earnings Update: Here's Why Analysts Just Lifted Their BioAge Labs, Inc. (NASDAQ:BIOA) Price Target To US$53.33
Simply Wall St.
Earnings Update: Here's Why Analysts Just Lifted Their BioAge Labs, Inc. (NASDAQ:BIOA) Price Target To US$53.33
BioAge Labs, Inc. (NASDAQ:BIOA) investors will be delighted, with the company turning in some strong numbers with its latest results. The results were impressive, with revenues of US$2.8m exceeding analyst forecasts by 156%, and statutory losses of US$0.52 were likewise much smaller than the analysts had forecast. This is an important time for investors, as they can track a company's performance in its report, look at what experts are forecasting for next year, and see if there has been any change to expectations for the business. So we gathered the latest post-earnings forecasts to see what estimates suggest is in store for next year. AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. Taking into account the latest results, the most recent consensus for BioAge Labs from eight analysts is for revenues of US$65.5m in 2026. If met, it would imply a sizeable 535% increase on its revenue over the past 12 months. The loss per share is expected to greatly reduce in the near future, narrowing 52% to US$0.96. Before this earnings announcement, the analysts had been modelling revenues of US$72.4m and losses of US$2.74 per share in 2026. Although the revenue estimates have fallen somewhat, BioAge Labs'future looks a little different to the past, with a very promising decrease in the loss per share forecasts in particular. View our latest analysis for BioAge Labs The consensus price target rose 33% to US$53.33, with the analysts increasingly optimistic about shrinking losses, despite the expected decline in revenue. That's not the only conclusion we can draw from this data however, as some investors also like to consider the spread in estimates when evaluating analyst price targets. Currently, the most bullish analyst values BioAge Labs at US$73.00 per share, while the most bearish prices it at US$23.00. Note the wide gap in analyst price targets? This implies to us that there is a fairly broad range of possible scenarios for the underlying business. Another way we can view these estimates is in the context of the bigger picture, such as how the forecasts stack up against past performance, and whether forecasts are more or less bullish relative to other companies in the industry. It's clear from the latest estim…Read full documentShow less
BioAge Labs, Inc. (NASDAQ:BIOA) investors will be delighted, with the company turning in some strong numbers with its latest results. The results were impressive, with revenues of US$2.8m exceeding analyst forecasts by 156%, and statutory losses of US$0.52 were likewise much smaller than the analysts had forecast. This is an important time for investors, as they can track a company's performance in its report, look at what experts are forecasting for next year, and see if there has been any change to expectations for the business. So we gathered the latest post-earnings forecasts to see what estimates suggest is in store for next year. AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. Taking into account the latest results, the most recent consensus for BioAge Labs from eight analysts is for revenues of US$65.5m in 2026. If met, it would imply a sizeable 535% increase on its revenue over the past 12 months. The loss per share is expected to greatly reduce in the near future, narrowing 52% to US$0.96. Before this earnings announcement, the analysts had been modelling revenues of US$72.4m and losses of US$2.74 per share in 2026. Although the revenue estimates have fallen somewhat, BioAge Labs'future looks a little different to the past, with a very promising decrease in the loss per share forecasts in particular. View our latest analysis for BioAge Labs The consensus price target rose 33% to US$53.33, with the analysts increasingly optimistic about shrinking losses, despite the expected decline in revenue. That's not the only conclusion we can draw from this data however, as some investors also like to consider the spread in estimates when evaluating analyst price targets. Currently, the most bullish analyst values BioAge Labs at US$73.00 per share, while the most bearish prices it at US$23.00. Note the wide gap in analyst price targets? This implies to us that there is a fairly broad range of possible scenarios for the underlying business. Another way we can view these estimates is in the context of the bigger picture, such as how the forecasts stack up against past performance, and whether forecasts are more or less bullish relative to other companies in the industry. It's clear from the latest estimates that BioAge Labs' rate of growth is expected to accelerate meaningfully, with the forecast 11x annualised revenue growth to the end of 2026 noticeably faster than its historical growth of 611% over the past year. Compare this with other companies in the same industry, which are forecast to grow their revenue 8.7% annually. It seems obvious that, while the growth outlook is brighter than the recent past, the analysts also expect BioAge Labs to grow faster than the wider industry. The most obvious conclusion is that the analysts made no changes to their forecasts for a loss next year. They also downgraded BioAge Labs' revenue estimates, but industry data suggests that it is expected to grow faster than the wider industry. With that said, earnings are more important to the long-term value of the business. We note an upgrade to the price target, suggesting that the analysts believes the intrinsic value of the business is likely to improve over time. With that said, the long-term trajectory of the company's earnings is a lot more important than next year. We have estimates - from multiple BioAge Labs analysts - going out to 2028, and you can see them free on our platform here. You should always think about risks though. Case in point, we've spotted 3 warning signs for BioAge Labs you should be aware of, and 1 of them doesn't sit too well with us. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2026-05-08BioAge Labs Reports First Quarter 2026 Financial Results and Provides Business Updates
GlobeNewswire
BioAge Labs Reports First Quarter 2026 Financial Results and Provides Business Updates
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 $132.3 million EMERYVILLE, Calif., May 08, 2026 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. (NASDAQ: BIOA) ("BioAge” or, "the Company"), a clinical-stage biopharmaceutical company developing therapeutic product candidates for cardiometabolic diseases by targeting the biology of human aging, today provided business updates and reported its first quarter 2026 financial results. “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 Kristen Fortney, Ph.D., CEO and co-founder of BioAge. "Our focus now is execution. We plan to initiate two BGE-102 proof-of-concept trials by mid-2026 — a Phase 2 dose-ranging trial in cardiovascular risk, and a Phase 1b/2a trial in diabetic macular edema — advancing BGE-102 as a potential 'pipeline in a pill' across cardiometabolic and ocular diseases. With the $132.3 million we raised in our upsized follow-on offering earlier this year, we have the capital to drive both programs through key milestones.” 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.…Read full documentShow less
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 $132.3 million EMERYVILLE, Calif., May 08, 2026 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. (NASDAQ: BIOA) ("BioAge” or, "the Company"), a clinical-stage biopharmaceutical company developing therapeutic product candidates for cardiometabolic diseases by targeting the biology of human aging, today provided business updates and reported its first quarter 2026 financial results. “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 Kristen Fortney, Ph.D., CEO and co-founder of BioAge. "Our focus now is execution. We plan to initiate two BGE-102 proof-of-concept trials by mid-2026 — a Phase 2 dose-ranging trial in cardiovascular risk, and a Phase 1b/2a trial in diabetic macular edema — advancing BGE-102 as a potential 'pipeline in a pill' across cardiometabolic and ocular diseases. With the $132.3 million we raised in our upsized follow-on offering earlier this year, we have the capital to drive both programs through key milestones.” 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 in February 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 $2.8 million for the quarter ended March 31, 2026, compared to $1.5 million for the same period in 2025. The $1.3 million increase in collaboration revenue was due to increased full-time equivalent employee (FTE) effort under the Novartis collaboration agreement, resulting in higher revenue recognized based on progress toward satisfaction of the related performance obligation. Research and development expenses were approximately $20.4 million for the quarter ended March 31, 2026, compared to $11.1 million for the same period in 2025. The $9.3 million increase in research and development expenses was primarily attributable to a $5.7 million increase in direct costs related to the BioAge’s BGE-102 program associated with the completion of the Phase 1 single ascending dose (SAD) / multiple ascending dose (MAD) clinical trial, preparation for the planned Phase 2 dose-ranging proof-of-concept trial evaluating BGE-102 in participants with elevated cardiovascular risk and planned Phase 1b/2a proof-of-concept trial in DME, each expected to initiate in mid-2026, and drug-product manufacturing. Additionally contributing to the increase was a $3.6 million increase in direct costs for other programs, which was primarily related to discovery and development activities related to BioAge’s novel apelin receptor APJ agonist programs, and a $0.8 million increase in allocated facility and other expenses primarily driven by an increase in non-program specific consulting fees. These increases were partially offset by a $0.8 million reduction in azelaprag direct costs following termination of development in January 2025. General and administrative expenses were $7.7 million for the quarter ended March 31, 2026, compared to $6.8 million for the same period in 2025. The $0.9 million increase was primarily attributable to a $0.6 million increase in personnel-related expenses, largely due to an increase in stock-based compensation expense associated with new option grants issued to employees, executives, board members, and advisors, and a $0.4 million increase in legal fees, partially offset by a $0.1 million decrease in consulting expenses. Net loss was $22.3 million for the quarter ended March 31, 2026, or $0.52 per weighted-average common share outstanding, basic and diluted, compared to a net loss of $12.9 million, or $0.36 per weighted-average common share outstanding, basic and diluted, for the same period in 2025. As of March 31, 2026, BioAge had approximately $384.9 million in cash, cash equivalents, and marketable securities. Based on its current operating plan, BioAge estimates that existing cash and cash equivalents will be sufficient to fund operations and capital expenses through 2029. About BioAge Labs, Inc. 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 United States, significant political, trade or regulatory developments, including tariffs, federal government shutdowns, or shifting priorities within the U.S. Food and Drug Administration, cybersecurity incidents, and global regional conflicts, and the plans and objectives of management for future operations and capital expenditures are forward-looking statements. 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 May 8, 2026, and BioAge’s other filings with the SEC filed from time to time. 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: Chris Patil, [email protected] IR: Dov Goldstein, [email protected] Partnering: [email protected] Web: https://bioagelabs.com
Investor releaseQuarter not tagged2026-03-24BioAge Labs Reports Full Year 2025 Financial Results and Provides Business Updates from the Fourth Quarter of 2025
GlobeNewswire
BioAge Labs Reports Full Year 2025 Financial Results and Provides Business Updates from the Fourth Quarter of 2025
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 $132.3 million with full exercise of the underwriters’ overallotment option in February 2026 EMERYVILLE, Calif., March 24, 2026 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. ("BioAge”, "the Company"), a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today provided financial results for the full year ended December 31, 2025 and business updates for the fourth quarter ended December 31, 2025. "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 Kristen Fortney, PhD, CEO and co-founder of BioAge. "These results support BGE-102's potential to deliver injectable-like anti-inflammatory efficacy in a convenient oral therapy, and we are advancing toward a Phase 2a proof-of-concept study in the first half of this year. We also expanded BGE-102 into ophthalmology, where its unique profile positions it as a potential 'pipeline in a pill' across cardiovascular, CNS, and ocular diseases. In parallel, we are actively advancing a follow-on NLRP3 inhibitor program to create optionality to address the many diseases driven by the inflammasome. With our upsized $132.3 million follow-on offering, we have further strengthened our balance sheet to support our expanding clinical programs." 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-1β in an ex vivo who…Read full documentShow less
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 $132.3 million with full exercise of the underwriters’ overallotment option in February 2026 EMERYVILLE, Calif., March 24, 2026 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. ("BioAge”, "the Company"), a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today provided financial results for the full year ended December 31, 2025 and business updates for the fourth quarter ended December 31, 2025. "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 Kristen Fortney, PhD, CEO and co-founder of BioAge. "These results support BGE-102's potential to deliver injectable-like anti-inflammatory efficacy in a convenient oral therapy, and we are advancing toward a Phase 2a proof-of-concept study in the first half of this year. We also expanded BGE-102 into ophthalmology, where its unique profile positions it as a potential 'pipeline in a pill' across cardiovascular, CNS, and ocular diseases. In parallel, we are actively advancing a follow-on NLRP3 inhibitor program to create optionality to address the many diseases driven by the inflammasome. With our upsized $132.3 million follow-on offering, we have further strengthened our balance sheet to support our expanding clinical programs." 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-1β 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 in May 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. In February 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 of December 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 $9.0 million for the year ended December 31, 2025, compared to no revenue for the same period in 2024. The $9.0 million increase in collaboration revenue was the result of revenue recognized under our multi-year research collaboration with Novartis, as work commenced in 2025. Research and development expenses were approximately $73.9 million for the year ended December 31, 2025, compared to $59.0 million for the same period in 2024. The $14.9 million increase in research and development expenses was primarily attributable to a $24.3 million increase in direct costs for other programs, primarily related to work performed under the Novartis Agreement and licensing, discovery and development activities related to our novel apelin receptor APJ agonist programs, and a $14.4 million increase in direct costs related to our BGE-102 program associated with IND-enabling activities, drug-product manufacturing and our ongoing Phase 1 SAD/MAD clinical trial. Further contributing to the increase in research and development expenses was a $1.2 million increase in personnel-related expenses, driven by stock-based compensation grants to employees, and a $1.4 million increase in allocated facility and other expenses primarily related to facility expenses for our new headquarters. These increases were partially offset by a $26.4 million reduction in azelaprag direct costs following termination of development in January 2025. General and administrative expenses were $27.8 million for the year ended December 31, 2025, compared to $19.2 million for the same period in 2024. The $8.6 million increase was primarily attributable to a $3.9 million increase in personnel-related expenses, largely due to an increase in stock-based compensation expense associated with new option grants issued to employees, executives, board members and advisors, a $2.9 million increase in legal fees, a $1.2 million increase in franchise taxes and insurance, primarily related to our public company director and officer insurance policy, and a $0.6 million increase in information technology and equipment costs, primarily related to software expense. Net loss was $80.6 million for the year ended December 31, 2025, or $2.24 per weighted-average common share outstanding, basic and diluted, compared to a net loss of $71.1 million, or $6.63 per weighted-average common share outstanding, basic and diluted, for the same period in 2024. As of December 31, 2025, BioAge had approximately $285.1 million in cash, cash equivalents, and marketable securities. Based on our current operating plan, BioAge estimates that existing cash and cash equivalents will be sufficient to fund operations and capital expenses through 2029. About BioAge Labs, Inc. 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 United States, significant political, trade or regulatory developments, including tariffs, federal government shutdowns, or shifting priorities within the U.S. Food and Drug Administration, cybersecurity incidents, and global regional conflicts, and the plans and objectives of management for future operations and capital expenditures are forward-looking statements. 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 March 24, 2026, and BioAge’s other filings with the SEC filed from time to time. 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: Chris Patil, [email protected] IR: Dov Goldstein, [email protected] Partnering: [email protected] Web: https://bioagelabs.com
Investor releaseQuarter not tagged2025-11-07BioAge Labs Reports Third Quarter 2025 Financial Results and Provides Business Updates
GlobeNewswire
BioAge Labs Reports Third Quarter 2025 Financial Results and Provides Business Updates
First participant dosed in Phase 1 trial of BGE-102, oral CNS-penetrant NLRP3 inhibitor, with initial SAD data expected by year-end Continued advancement of oral and parenteral APJ agonist programs targeting 2026 IND submissions EMERYVILLE, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. ("BioAge", "the Company"), a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today provided business updates and reported its third quarter 2025 financial results. “The third quarter of 2025 marked an important milestone as we advanced BGE-102 into clinical development with the dosing of our first participant in the Phase 1 trial,” said Kristen Fortney, PhD, CEO and co-founder of BioAge. “We're on track to deliver initial single ascending dose data by year-end, providing critical insights into the safety, pharmacokinetics, and target engagement of this potential best-in-class oral, CNS penetrant NLRP3 inhibitor. We also continued to advance our oral and parenteral APJ agonist programs toward 2026 IND submissions, while our partnerships with Novartis and Lilly continue to progress as expected. The Company remains focused on strategic execution to deliver transformative therapies targeting the biology of metabolic aging.” Third Quarter 2025 Business Highlights NLRP3 inhibitor program clinical development In August 2025, BioAge announced that the first participant was dosed in a Phase 1 clinical trial evaluating BGE-102, a structurally novel, orally available small molecule NLRP3 inhibitor with high potency and brain penetration being developed initially for obesity and cardiovascular risk factors. The Phase 1 study is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102 in healthy participants. Initial single ascending dose (SAD) data are anticipated by the end of 2025. Following successful completion of the Phase 1 SAD/MAD, the Company plans to initiate a proof-of-concept clinical trial for BGE-102, with top-line data for this study anticipated in the second half of 2026. 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…Read full documentShow less
First participant dosed in Phase 1 trial of BGE-102, oral CNS-penetrant NLRP3 inhibitor, with initial SAD data expected by year-end Continued advancement of oral and parenteral APJ agonist programs targeting 2026 IND submissions EMERYVILLE, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. ("BioAge", "the Company"), a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today provided business updates and reported its third quarter 2025 financial results. “The third quarter of 2025 marked an important milestone as we advanced BGE-102 into clinical development with the dosing of our first participant in the Phase 1 trial,” said Kristen Fortney, PhD, CEO and co-founder of BioAge. “We're on track to deliver initial single ascending dose data by year-end, providing critical insights into the safety, pharmacokinetics, and target engagement of this potential best-in-class oral, CNS penetrant NLRP3 inhibitor. We also continued to advance our oral and parenteral APJ agonist programs toward 2026 IND submissions, while our partnerships with Novartis and Lilly continue to progress as expected. The Company remains focused on strategic execution to deliver transformative therapies targeting the biology of metabolic aging.” Third Quarter 2025 Business Highlights NLRP3 inhibitor program clinical development In August 2025, BioAge announced that the first participant was dosed in a Phase 1 clinical trial evaluating BGE-102, a structurally novel, orally available small molecule NLRP3 inhibitor with high potency and brain penetration being developed initially for obesity and cardiovascular risk factors. The Phase 1 study is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102 in healthy participants. Initial single ascending dose (SAD) data are anticipated by the end of 2025. Following successful completion of the Phase 1 SAD/MAD, the Company plans to initiate a proof-of-concept clinical trial for BGE-102, with top-line data for this study anticipated in the second half of 2026. 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 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 in May 2025. Both programs are targeting IND submissions in 2026. Strategic partnerships 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. 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. Third Quarter 2025 Financial Results Collaboration revenue was $2.1 million for the quarter ended September 30, 2025 compared to no revenue for the same period in 2024. The $2.1 million increase in collaboration revenue was the result of revenue recognized under our multi-year research collaboration with Novartis, as work commenced in 2025. Research and development expenses were $18.5 million for the quarter ended September 30, 2025, compared to $20.0 million for the same period in 2024. The $1.5 million decrease in research and development expenses was primarily attributable to a $13.1 million reduction in azelaprag direct costs as development was terminated in January 2025. The decrease in azelaprag research and development expenses was partially offset by a $6.5 million increase in direct costs for other programs, which was primarily related to discovery and development activities related to our novel apelin receptor APJ agonist programs, a $4.4 million increase in direct costs related to our BGE-102 program associated with our Phase 1 SAD/MAD clinical trial and drug-product manufacturing, and a $0.8 million increase in allocated facility and other expenses primarily driven by an increase in non-program specific consulting fees. General and administrative expenses were $6.7 million for the quarter ended September 30, 2025, compared to $4.7 million for the same period in 2024. The $2.0 million increase was primarily attributable to $0.8 million increase in legal fees, a $0.5 million increase personnel-related expenses, largely due to an increase in stock-based compensation expense associated with new option grants, a $0.3 million increase in taxes and insurance, primarily related to our public-company director and officer insurance policy. Net loss was $20.2 million for the quarter ended September 30, 2025, or $0.56 per weighted-average common share outstanding, basic and diluted, compared to a net loss of $23.4 million, or $6.70 per weighted-average common share outstanding, basic and diluted, for the same period in 2024. As of September 30, 2025, BioAge had approximately $295.9 million in cash, cash equivalents, and marketable securities. Based on our current operating plan, BioAge estimates that existing cash, cash equivalents, and marketable securities will be sufficient to fund operations and capital expenses through 2029. About BioAge Labs, Inc. 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 obesity and cardiovascular risk factors. A Phase 1 SAD/MAD trial of BGE-102 is underway, with initial SAD data anticipated by end of year. 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. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our plans to develop and commercialize our product candidates, including BGE-102 and our APJ program, the potential for BGE-102 as a treatment for obesity and the expected timeline for data readout from our ongoing Phase 1 clinical trial, the timing and results of our clinical trials, risks associated with clinical trials, including our ability to adequately manage clinical activities, the timing of our IND filing for our APJ program, the timing of and our ability to obtain and maintain regulatory approvals, the clinical utility of our product candidates, the sufficiency of our cash and cash equivalents, and general economic, industry and market conditions. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “potential,” “possible,” “will,” “would,” and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our ability to develop, obtain regulatory approval for and commercialize our product candidates; the timing and results of preclinical studies and clinical trials; the risk that positive results in a preclinical study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events; failure to protect and enforce our intellectual property, and other proprietary rights; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; risks relating to technology failures or breaches; our dependence on collaborators and other third parties for the development of product candidates and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions, including due to the imposition of tariffs and other trade barriers; risks associated with current and potential future healthcare reforms; risks relating to attracting and retaining key personnel; changes in or failure to comply with legal and regulatory requirements, including shifting priorities within the U.S. Food and Drug Administration; risks relating to access to capital and credit markets; and the other risks and uncertainties that are detailed under the heading “Risk Factors” included in BioAge’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on November 6, 2025, and BioAge’s other filings with the SEC filed from time to time. 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: Chris Patil, [email protected] IR: Dov Goldstein, [email protected] Partnering: [email protected] Web: https://bioagelabs.com
Investor releaseQuarter not tagged2025-08-07BioAge Labs Reports Second Quarter 2025 Financial Results and Provides Business Updates
GlobeNewswire
BioAge Labs Reports Second Quarter 2025 Financial Results and Provides Business Updates
Oral NLRP3 inhibitor BGE-102 on track for Phase 1 initiation in 2H 2025 with initial data by year-end Expanded APJ agonist pipeline through option agreement for novel antibody and advancement of proprietary oral small molecules Strengthened discovery platform through molecular profiling of 17,000+ samples from leading European HUNT Biobank EMERYVILLE, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. ("BioAge", “the Company”), a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today provided business updates and reported its second quarter 2025 financial results. “In Q2 2025, BioAge achieved key milestones across our clinical pipeline and discovery platform,” said Kristen Fortney, CEO and co-founder of BioAge. “We completed IND-enabling studies for our potential best-in-class oral NLRP3 inhibitor, BGE-102, positioning us to initiate Phase 1 trials later this year, with initial SAD data expected by year-end. We strengthened our apelin pipeline by securing a partnership for potent APJ agonist antibodies and filing patent applications for novel oral small molecules. We also launched a collaboration with the HUNT Biobank to generate millions of new data points, fueling our analysis of human longevity. I’m proud of our progress as we advance our mission to develop transformative therapies for metabolic diseases.” Second Quarter 2025 Business Highlights NLRP3 inhibitor program development In May 2025, BioAge announced the completion of IND-enabling studies for BGE-102, an orally available, brain-penetrant NLRP3 inhibitor being initially developed for obesity. BGE-102 demonstrated significant weight loss in preclinical models both as monotherapy and in combination with the GLP-1 receptor agonist semaglutide. The Company plans to initiate a Phase 1 SAD/MAD clinical trial in the second half of 2025, with initial single ascending dose (SAD) data anticipated by year-end. APJ agonist pipeline expansion In June 2025, BioAge entered into an exclusive option agreement with JiKang Therapeutics (“JiKang”) to potentially in-license a novel APJ agonist nanobody (single-domain antibody) that demonstrates at least 10-fold greater potency than apelin, the natural ligand of APJ. Under the agreement, BioAge and JiKang will jointly advance the nanobody to the beginning of IND-enab…Read full documentShow less
Oral NLRP3 inhibitor BGE-102 on track for Phase 1 initiation in 2H 2025 with initial data by year-end Expanded APJ agonist pipeline through option agreement for novel antibody and advancement of proprietary oral small molecules Strengthened discovery platform through molecular profiling of 17,000+ samples from leading European HUNT Biobank EMERYVILLE, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. ("BioAge", “the Company”), a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today provided business updates and reported its second quarter 2025 financial results. “In Q2 2025, BioAge achieved key milestones across our clinical pipeline and discovery platform,” said Kristen Fortney, CEO and co-founder of BioAge. “We completed IND-enabling studies for our potential best-in-class oral NLRP3 inhibitor, BGE-102, positioning us to initiate Phase 1 trials later this year, with initial SAD data expected by year-end. We strengthened our apelin pipeline by securing a partnership for potent APJ agonist antibodies and filing patent applications for novel oral small molecules. We also launched a collaboration with the HUNT Biobank to generate millions of new data points, fueling our analysis of human longevity. I’m proud of our progress as we advance our mission to develop transformative therapies for metabolic diseases.” Second Quarter 2025 Business Highlights NLRP3 inhibitor program development In May 2025, BioAge announced the completion of IND-enabling studies for BGE-102, an orally available, brain-penetrant NLRP3 inhibitor being initially developed for obesity. BGE-102 demonstrated significant weight loss in preclinical models both as monotherapy and in combination with the GLP-1 receptor agonist semaglutide. The Company plans to initiate a Phase 1 SAD/MAD clinical trial in the second half of 2025, with initial single ascending dose (SAD) data anticipated by year-end. APJ agonist pipeline expansion In June 2025, BioAge entered into an exclusive option agreement with JiKang Therapeutics (“JiKang”) to potentially in-license a novel APJ agonist nanobody (single-domain antibody) that demonstrates at least 10-fold greater potency than apelin, the natural ligand of APJ. Under the agreement, BioAge and JiKang will jointly advance the nanobody to the beginning of IND-enabling studies, with BioAge holding an exclusive, pre-negotiated option to license the program for worldwide development and commercialization across all indications. In May 2025, BioAge filed a U.S. provisional patent application for a new class of orally active, chemically distinct APJ agonists with picomolar potency and drug-like properties including high solubility and metabolic stability. Discovery platform expansion In June 2025, BioAge announced the launch of an initiative to comprehensively profile and analyze samples from the HUNT Biobank in Norway through its collaboration with Age Labs AS. BioAge will profile more than 17,000 individual samples from 6,000+ participants to generate millions of molecular measurements tracking the transition from health to disease over decades of lifespan. The Company has exclusive access for drug discovery purposes to data generated by the partnership. Strategic partnerships The Company continued to advance its multi-year research collaboration with Novartis, announced in December 2024, focused on discovering novel therapeutic targets at the intersection of aging biology and exercise physiology, with multiple targets under evaluation. BioAge progressed its strategic collaboration with Lilly ExploR&D, announced in January 2025, for the development of therapeutic antibodies targeting novel metabolic aging targets identified through BioAge's discovery platform. Second Quarter 2025 Financial Results Research and development expenses were $19.8 million for the quarter ended June 30, 2025, compared to $10.5 million for the same period in 2024. The $9.3 million increase in research and development expenses was primarily attributable to a $8.0 million increase in direct costs related to licensing, discovery, and development activities related to our novel apelin receptor APJ agonist programs. Additionally contributing to the increase in research and development expenses was a $3.0 million increase in direct costs related to our BGE-102 program associated with IND-enabling activities and drug-product manufacturing. These higher costs were partially offset by a $1.7 million reduction in azelaprag direct costs as development was terminated in January 2025. General and administrative expenses were $7.3 million for the quarter ended June 30, 2025, compared to $4.8 million for the same period in 2024. The $2.5 million increase was primarily attributable to a $1.5 million increase in personnel-related expenses, which was largely attributable to increased stock-based compensation expense associated with option grants issued to employees, executives, board members and advisors. Additionally, contributing to the increase was a $0.9 million increase in legal fees. Net loss was $21.6 million for the quarter ended June 30, 2025, or $0.60 per weighted-average common share outstanding, basic and diluted, compared to a net loss of $13.6 million, or $7.94 per weighted-average common share outstanding, basic and diluted, for the same period in 2024. As of June 30, 2025, BioAge had approximately $313.4 million in cash, cash equivalents, and marketable securities. Based on our current operating plan, BioAge estimates that existing cash, cash equivalents, and marketable securities will be sufficient to fund operations and capital expenses through 2029. About BioAge Labs, Inc. 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 obesity. BGE-102 has demonstrated significant weight loss in preclinical models both as monotherapy and in combination with GLP-1 receptor agonists. Initiation of a Phase 1 SAD/MAD trial is planned for the second half of 2025, with initial SAD data anticipated by end of year. 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. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our plans to develop and commercialize our product candidates, the timing and results of our planned clinical trials, risks associated with clinical trials, including our ability to adequately manage clinical activities, the timing of and our ability to obtain and maintain regulatory approvals, the clinical utility of our product candidates, the sufficiency of our cash and cash equivalents, and general economic, industry and market conditions. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “potential,” “possible,” “will,” “would,” and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our ability to develop, obtain regulatory approval for and commercialize our product candidates; the timing and results of preclinical studies and clinical trials; the risk that positive results in a preclinical study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events; failure to protect and enforce our intellectual property, and other proprietary rights; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; risks relating to technology failures or breaches; our dependence on collaborators and other third parties for the development of product candidates and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions, including due to the imposition of tariffs and other trade barriers; risks associated with current and potential future healthcare reforms; risks relating to attracting and retaining key personnel; changes in or failure to comply with legal and regulatory requirements, including shifting priorities within the U.S. Food and Drug Administration; risks relating to access to capital and credit markets; and the other risks and uncertainties that are detailed under the heading “Risk Factors” included in BioAge’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on August 6, 2025, and BioAge’s other filings with the SEC filed from time to time. 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: Chris Patil, [email protected] IR: Dov Goldstein, [email protected] Partnering: [email protected] Web: https://bioagelabs.com
Investor releaseQuarter not tagged2025-05-07BioAge Labs Reports First Quarter 2025 Financial Results and Provides Business Updates
GlobeNewswire
BioAge Labs Reports First Quarter 2025 Financial Results and Provides Business Updates
Advancement of lead candidate BGE-102, an oral, brain-penetrant NLRP3 inhibitor for obesity, with initial clinical data expected 2H25 New strategic collaboration with Lilly ExploR&D expands therapeutic approach to novel metabolic aging targets Progression of preclinical next-generation APJ agonists for obesity RICHMOND, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. ("BioAge", “the Company”), a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging, today provided business updates and reported its first quarter 2025 financial results. “The first quarter of 2025 was marked by strategic execution as we advanced our focused pipeline," said Kristen Fortney, Ph.D., CEO and co-founder of BioAge. "We've made significant progress with BGE-102, our brain-penetrant NLRP3 inhibitor, and are on track with IND-enabling studies to bring this potential best-in-class compound to the clinic this year, with initial Phase 1 data expected before year-end. Our new collaboration with Lilly expands our therapeutic capabilities into antibodies while validating our platform-driven approach to targeting the biology of aging. Meanwhile, both our novel APJ agonist program and our partnership with Novartis continue to make meaningful progress. With these scientific advancements and our strong financial position, we're well-positioned to deliver on our mission to leverage the biology of aging to develop transformative treatments for metabolic diseases." First Quarter 2025 Business Highlights NLRP3 program development In January 2025, BioAge nominated BGE-102, a novel, orally available small-molecule NLRP3 inhibitor, as its lead development candidate for obesity. The compound shows potential best-in-class potency and brain penetration, and can target diseases driven by neuroinflammation including metabolic conditions and obesity. In preclinical studies, NLRP3 inhibition has demonstrated significant weight loss potential. IND-enabling studies are currently underway, with initial Phase 1 data anticipated in the second half of 2025. Strategic collaborations In January 2025, BioAge announced a strategic collaboration with Lilly ExploR&D to develop two therapeutic antibodies targeting novel metabolic aging targets identified through BioAge's discovery platform. Pipelin…Read full documentShow less
Advancement of lead candidate BGE-102, an oral, brain-penetrant NLRP3 inhibitor for obesity, with initial clinical data expected 2H25 New strategic collaboration with Lilly ExploR&D expands therapeutic approach to novel metabolic aging targets Progression of preclinical next-generation APJ agonists for obesity RICHMOND, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. ("BioAge", “the Company”), a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging, today provided business updates and reported its first quarter 2025 financial results. “The first quarter of 2025 was marked by strategic execution as we advanced our focused pipeline," said Kristen Fortney, Ph.D., CEO and co-founder of BioAge. "We've made significant progress with BGE-102, our brain-penetrant NLRP3 inhibitor, and are on track with IND-enabling studies to bring this potential best-in-class compound to the clinic this year, with initial Phase 1 data expected before year-end. Our new collaboration with Lilly expands our therapeutic capabilities into antibodies while validating our platform-driven approach to targeting the biology of aging. Meanwhile, both our novel APJ agonist program and our partnership with Novartis continue to make meaningful progress. With these scientific advancements and our strong financial position, we're well-positioned to deliver on our mission to leverage the biology of aging to develop transformative treatments for metabolic diseases." First Quarter 2025 Business Highlights NLRP3 program development In January 2025, BioAge nominated BGE-102, a novel, orally available small-molecule NLRP3 inhibitor, as its lead development candidate for obesity. The compound shows potential best-in-class potency and brain penetration, and can target diseases driven by neuroinflammation including metabolic conditions and obesity. In preclinical studies, NLRP3 inhibition has demonstrated significant weight loss potential. IND-enabling studies are currently underway, with initial Phase 1 data anticipated in the second half of 2025. Strategic collaborations In January 2025, BioAge announced a strategic collaboration with Lilly ExploR&D to develop two therapeutic antibodies targeting novel metabolic aging targets identified through BioAge's discovery platform. Pipeline advancement The Company continues to advance its portfolio of novel, structurally differentiated APJ agonists for obesity and related metabolic conditions, with the goal of nominating a development candidate by the end of 2025. BioAge's multi-year research collaboration with Novartis, focused on discovering novel therapeutic targets at the intersection of aging biology and exercise physiology, continues to make meaningful progress. First Quarter 2025 Financial Results Research and development expenses were $11.1 million for the quarter ended March 31, 2025, compared to $9.3 million for the same period in 2024. The $1.8 million increase in research and development expenses was primarily attributable to a $2.7 million increase in direct costs related to other programs as BioAge focused its research and development activities on IND-enabling activities for BGE-102. General and administrative expenses were $6.8 million for the quarter ended March 31, 2025,, compared to $3.5 million for the same period in 2024. The $3.3 million increase was primarily attributable to a $2.0 million increase in personnel-related expenses, which was largely attributable to increased stock-based compensation expense associated with option grants issued to employees, executives, board members and advisors. Additionally, contributing to the increase was a $0.5 million increase in legal fees, and a $0.4 million increase in taxes and insurance, primarily related to our public-company director and officer insurance policy. Net loss was $12.9 million for the quarter ended March 31, 2025, or $0.36 per weighted-average common share outstanding, basic and diluted, compared to a net loss of $13.0 million, or $7.76 per weighted-average common share outstanding, basic and diluted, for the same period in 2024. As of March 31, 2025, BioAge had approximately $335.1 million in cash, cash equivalents, and marketable securities. Based on our current operating plan, BioAge estimates that existing cash, cash equivalents, and marketable securities will be sufficient to fund operations and capital expenses through 2029. About BioAge Labs, Inc. BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging. The company’s pipeline includes novel, orally available, brain-penetrant small-molecule NLRP3 inhibitors to treat metabolic diseases and conditions driven by neuroinflammation, as well as novel APJ agonists for metabolic disorders. 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. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our plans to develop and commercialize our product candidates, the timing and results of our planned clinical trials, risks associated with clinical trials, including our ability to adequately manage clinical activities, the timing of and our ability to obtain and maintain regulatory approvals, the clinical utility of our product candidates, the sufficiency of our cash and cash equivalents, and general economic, industry and market conditions. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “potential,” “possible,” “will,” “would,” and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our ability to develop, obtain regulatory approval for and commercialize our product candidates; the timing and results of preclinical studies and clinical trials; the risk that positive results in a preclinical study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events; failure to protect and enforce our intellectual property, and other proprietary rights; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; risks relating to technology failures or breaches; our dependence on collaborators and other third parties for the development of product candidates and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions, including due to the imposition of tariffs and other trade barriers; risks associated with current and potential future healthcare reforms; risks relating to attracting and retaining key personnel; changes in or failure to comply with legal and regulatory requirements, including shifting priorities within the U.S. Food and Drug Administration; risks relating to access to capital and credit markets; and the other risks and uncertainties that are detailed under the heading “Risk Factors” included in BioAge’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on May 6, 2025, and BioAge’s other filings with the SEC filed from time to time. 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. ContactsPR: Chris Patil, [email protected] IR: Dov Goldstein, [email protected] Partnering: [email protected] Web: https://bioagelabs.com
Investor releaseQuarter not tagged2025-03-21BioAge Labs Reports Full Year 2024 Financial Results and Provides Business Updates from the Fourth Quarter of 2024
GlobeNewswire
BioAge Labs Reports Full Year 2024 Financial Results and Provides Business Updates from the Fourth Quarter of 2024
Advancement of oral, brain-penetrant NLRP3 inhibitor BGE-102, with initial clinical data expected 2H25 Progression of preclinical next-generation APJ agonists for obesity New platform partnerships with Novartis and Lilly to discover and develop novel therapies for conditions driven by metabolic aging RICHMOND, Calif., March 20, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. ("BioAge", “the Company”), a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging, today provided financial results for the full year ended December 31, 2024 and business updates for the fourth quarter ended December 31, 2024. "The fourth quarter of 2024 was marked by key strategic decisions and solid pipeline progress,” said Kristen Fortney, Ph.D., CEO and co-founder of BioAge. “After careful evaluation of the clinical data for our APJ agonist azelaprag, we made the decision to discontinue its development. We continue to progress our chemically distinct APJ agonists. In parallel, we are advancing our development candidate BGE-102, an oral, brain-penetrant NLRP3 inhibitor with best-in-class potential across multiple metabolic conditions driven by neuroinflammation, including obesity. We have accelerated our clinical timelines for BGE-102, with initial Phase 1 data expected by year’s end. More broadly, our new research collaborations with Novartis and Lilly further validate our platform’s potential to identify novel therapeutic targets. With a robust balance sheet and multiple promising programs advancing toward the clinic, we are well-positioned to execute on our strategy and deliver transformative treatments for metabolic diseases." Fourth Quarter 2024 Business Highlights APJ agonists: azelaprag discontinued; Company continues to advance next-gen agonists In December 2024, BioAge discontinued the STRIDES Phase 2 clinical trial evaluating azelaprag, an orally available small-molecule agonist of APJ, in combination with tirzepatide for the treatment of obesity. The Company’s decision followed observations of unexpected liver transaminitis without clinically significant symptoms in some patients in the azelaprag arms of the STRIDES trial. In previous GLP toxicology studies and Phase 1 studies conducted by Amgen and BioAge, azelaprag was generally well tolerated, without predicted risk of…Read full documentShow less
Advancement of oral, brain-penetrant NLRP3 inhibitor BGE-102, with initial clinical data expected 2H25 Progression of preclinical next-generation APJ agonists for obesity New platform partnerships with Novartis and Lilly to discover and develop novel therapies for conditions driven by metabolic aging RICHMOND, Calif., March 20, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. ("BioAge", “the Company”), a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging, today provided financial results for the full year ended December 31, 2024 and business updates for the fourth quarter ended December 31, 2024. "The fourth quarter of 2024 was marked by key strategic decisions and solid pipeline progress,” said Kristen Fortney, Ph.D., CEO and co-founder of BioAge. “After careful evaluation of the clinical data for our APJ agonist azelaprag, we made the decision to discontinue its development. We continue to progress our chemically distinct APJ agonists. In parallel, we are advancing our development candidate BGE-102, an oral, brain-penetrant NLRP3 inhibitor with best-in-class potential across multiple metabolic conditions driven by neuroinflammation, including obesity. We have accelerated our clinical timelines for BGE-102, with initial Phase 1 data expected by year’s end. More broadly, our new research collaborations with Novartis and Lilly further validate our platform’s potential to identify novel therapeutic targets. With a robust balance sheet and multiple promising programs advancing toward the clinic, we are well-positioned to execute on our strategy and deliver transformative treatments for metabolic diseases." Fourth Quarter 2024 Business Highlights APJ agonists: azelaprag discontinued; Company continues to advance next-gen agonists In December 2024, BioAge discontinued the STRIDES Phase 2 clinical trial evaluating azelaprag, an orally available small-molecule agonist of APJ, in combination with tirzepatide for the treatment of obesity. The Company’s decision followed observations of unexpected liver transaminitis without clinically significant symptoms in some patients in the azelaprag arms of the STRIDES trial. In previous GLP toxicology studies and Phase 1 studies conducted by Amgen and BioAge, azelaprag was generally well tolerated, without predicted risk of transaminitis or liver injury. The Company is continuing to develop APJ agonists structurally distinct from azelaprag for obesity and related metabolic conditions. NLRP3 inhibitors: progression of BGE-102, with initial clinical data expected 2H25 In January 2025, BioAge nominated BGE-102, a member of its novel, proprietary class of orally available small-molecule NLRP3 inhibitors with distinctive structural and biological properties, as a development candidate. BGE-102 has potential best-in-class features, including high potency and high brain penetration, important attributes for a compound that could be used for treatment of neuroinflammation linked to conditions such as obesity. Potential for use in an oral combination for obesity: in preclinical models, NLRP3 inhibition has demonstrated weight loss both as a monotherapy and in combination with a GLP-1 receptor agonist IND-enabling experiments for BGE-102 are currently underway, with Phase 1 single ascending dose (SAD) data anticipated in 2H25 and multiple ascending dose (MAD) data anticipated in 1H26. Platform and broader pipeline: Strategic collaborations with Novartis and Lilly In December 2024, BioAge established a multi-year collaboration with Novartis to discover novel targets for therapies that address age-related diseases and conditions. The collaboration will leverage insights from BioAge's unique longitudinal human aging datasets and Novartis expertise in the biology of physical exercise to identify drug targets to treat diseases related to aging. This complementary approach aims to translate insights from BioAge's platform into novel therapies that could address fundamental mechanisms of metabolic decline. Novartis will pay up to $20 million comprising upfront payments and research funding; BioAge may receive up to $530 million in future long-term research, development, and commercial milestones [link]. In January 2025, BioAge announced that the Company has entered a strategic collaboration with Lilly ExploR&D (part of Lilly Catalyze360) to discover two therapeutic antibodies that address novel metabolic aging targets identified through BioAge's discovery platform. This collaboration complements BioAge's small molecule expertise and broadens the modalities through which the Company can address targets emerging from its proprietary platform. Full Year 2024 Financial Results Research and development expenses were $59.0 million for the year ended December 31, 2024, compared to $33.9 million for the same period in 2023. The $25.1 million increase in research and development expenses was primarily attributable to a $22.8 million increase in costs related to the development of azelaprag driven by the Phase 2 STRIDES trial and costs related to the manufacture of azelaprag. General and administrative expenses were $19.2 million for the year ended December 31, 2024, compared to $14.5 million for the same period in 2023. The $4.7 million increase was primarily attributable to an increase in stock-based compensation expense associated with option grants issued in 2024 to employees, executives, board members and advisors. Net loss was $71.1 million for the year ended December 31, 2024, or $6.63 per weighted-average common share outstanding, basic and diluted, compared to a net loss of $63.9 million, or $38.17 per weighted-average common share outstanding, basic and diluted, for the same period in 2023. As of December 31, 2024, BioAge had approximately $354.3 million in cash and cash equivalents. Based on our current operating plan, BioAge estimates that existing cash and cash equivalents will be sufficient to fund operations and capital expenses through 2029. About BioAge Labs, Inc. BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging. The company’s pipeline includes novel, orally available, brain-penetrant small-molecule NLRP3 inhibitors to treat metabolic diseases and conditions driven by neuroinflammation, as well as novel APJ agonists for metabolic disorders. 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. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements related to our anticipated preclinical and clinical development activities, timing of announcements of clinical results for BGE-102, trial initiation, and regulatory filings, potential benefits of the Company’s other product candidates and platform, the potential and timing of future milestone payments under the agreement with Novartis, the success or outcomes associated with the Company’s collaboration with Lilly ExploR&D, the sufficiency of our cash and cash equivalents and current cash runway. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “potential,” “possible,” “will,” “would,” and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our ability to develop, obtain regulatory approval for and commercialize our product candidates; the timing and results of preclinical studies and clinical trials; the risk that positive results in a preclinical study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events; failure to protect and enforce our intellectual property, and other proprietary rights; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; risks relating to technology failures or breaches; our dependence on collaborators and other third parties for the development of product candidates and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions; risks associated with current and potential future healthcare reforms; risks relating to attracting and retaining key personnel; failure to comply with legal and regulatory requirements; risks relating to access to capital and credit markets; and the other risks and uncertainties that are detailed under the heading “Risk Factors” included in BioAge’s Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 20, 2025, and BioAge’s quarterly reports and other filings with the SEC filed from time to time. 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.ContactsPR: Chris Patil, [email protected] IR: Dov Goldstein, [email protected] Partnering: [email protected] Web: https://bioagelabs.com

