Latest news with #KristenFortney
Associated Press
10 hours ago
- Health
- Associated Press
BioAge Labs to Present Preclinical Data on APJ Agonism for Diabetic Obesity and Heart Failure at the American Diabetes Association (ADA) 85th Scientific Sessions
Treatment with apelin receptor agonist enhanced glycemic control and demonstrated cardioprotective effects, with additive benefits observed in combination with incretin therapy Data support development of next-generation APJ agonists for obesity and key comorbidities EMERYVILLE, Calif., June 21, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. (Nasdaq: BIOA) ('BioAge', 'the Company'), a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today announced that it will present new preclinical data supporting apelin receptor (APJ) agonism for the treatment of diabetic obesity and heart failure with preserved ejection fraction (HFpEF). The data will be presented at the American Diabetes Association's 85th Scientific Sessions, held June 20–23, 2025, in Chicago, Illinois. 'Our preclinical data demonstrated that APJ activation can confer multiple benefits in models of diabetic obesity and heart failure, and enhance the effects of incretin therapy,' said Kristen Fortney, PhD, CEO and co‑founder of BioAge. 'We are advancing next‑generation APJ agonists to translate this promising biology into new therapies for obesity and its major comorbidities.' APJ is the receptor for apelin, an exercise-induced signaling molecule known as an exerkine. Apelin has been shown in preclinical studies to have the potential to recapitulate many of the downstream benefits of exercise. BioAge's discovery platform identified apelin signaling as a therapeutic target based on analysis of human aging cohorts, which revealed that higher levels of circulating apelin are predictive of improved physical function and increased longevity. BioAge has shown that in preclinical obesity models, APJ agonism can approximately double the weight loss induced by GLP-1 receptor agonists while restoring body composition and muscle function, suggesting that APJ agonists could serve as pharmacological exercise mimetics to enhance incretin therapy. BioAge is advancing multiple APJ agonist approaches, including both oral small-molecule and long-acting injectable formulations, with an IND filing targeted for 2026 [ link ]. In their two presentations, BioAge CMO and EVP Research Paul Rubin, MD, and scientist Shijun Yan, PhD, MBA, will present data that demonstrated that in preclinical models of diabetic obesity and HFpEF, APJ agonist treatment had potential as monotherapy that could be enhanced in combination with incretin therapies. Oral presentation: Saturday Jun 21, 2025 5:00 PM - 5:15 PM CDT Title: An Oral Apelin Receptor Agonist Enhances Glycemic Control in Preclinical Models of Diabetic Obesity Both as Monotherapy and in Combination with Tirzepatide Session: Early Phase, Post Hoc, and Subgroup Analyses from Clinical Trials Testing Incretin-Based Therapies—Take 1; W181 A-C Presenter: Paul Rubin, MD, Chief Medical Officer and EVP-Research Poster presentation: Sunday Jun 22, 2025 12:30 PM - 1:30 PM CDT Title: The Apelin Receptor Agonist Azelaprag Shows Cardioprotective Effects as Monotherapy and Enhanced Benefits with Semaglutide in a Diet-Induced Obesity Model of Heart Failure with Preserved Ejection Fraction Session: Poster Hall F1, Board No. 866 Presenter: Shijun Yan, PhD, MBA, Senior Scientist, In Vivo Biology The visual materials for the presentations will be made available on the BioAge investor website concurrent with the beginning of their respective sessions. 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. IND submission and initiation of a Phase 1 SAD/MAD trial are planned for mid-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, including BGE-102 and our APJ program, 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 our IND filing for BGE-102 or our APJ program, our ability to obtain and maintain regulatory approvals, the clinical utility of our product candidates or their ultimate ability to treat human disease, the expected timeline for completing proteomic analysis, anticipated analytical results and the potential for identifying novel therapeutic targets, 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. Contacts PR: Chris Patil, [email protected] IR: Dov Goldstein, [email protected] Partnering: [email protected] Web:
Yahoo
13 hours ago
- Health
- Yahoo
BioAge Labs to Present Preclinical Data on APJ Agonism for Diabetic Obesity and Heart Failure at the American Diabetes Association (ADA) 85th Scientific Sessions
Treatment with apelin receptor agonist enhanced glycemic control and demonstrated cardioprotective effects, with additive benefits observed in combination with incretin therapy Data support development of next-generation APJ agonists for obesity and key comorbidities EMERYVILLE, Calif., June 21, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. (Nasdaq: BIOA) ('BioAge', 'the Company'), a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today announced that it will present new preclinical data supporting apelin receptor (APJ) agonism for the treatment of diabetic obesity and heart failure with preserved ejection fraction (HFpEF). The data will be presented at the American Diabetes Association's 85th Scientific Sessions, held June 20–23, 2025, in Chicago, Illinois. 'Our preclinical data demonstrated that APJ activation can confer multiple benefits in models of diabetic obesity and heart failure, and enhance the effects of incretin therapy,' said Kristen Fortney, PhD, CEO and co‑founder of BioAge. 'We are advancing next‑generation APJ agonists to translate this promising biology into new therapies for obesity and its major comorbidities.' APJ is the receptor for apelin, an exercise-induced signaling molecule known as an exerkine. Apelin has been shown in preclinical studies to have the potential to recapitulate many of the downstream benefits of exercise. BioAge's discovery platform identified apelin signaling as a therapeutic target based on analysis of human aging cohorts, which revealed that higher levels of circulating apelin are predictive of improved physical function and increased longevity. BioAge has shown that in preclinical obesity models, APJ agonism can approximately double the weight loss induced by GLP-1 receptor agonists while restoring body composition and muscle function, suggesting that APJ agonists could serve as pharmacological exercise mimetics to enhance incretin therapy. BioAge is advancing multiple APJ agonist approaches, including both oral small-molecule and long-acting injectable formulations, with an IND filing targeted for 2026 [link]. In their two presentations, BioAge CMO and EVP Research Paul Rubin, MD, and scientist Shijun Yan, PhD, MBA, will present data that demonstrated that in preclinical models of diabetic obesity and HFpEF, APJ agonist treatment had potential as monotherapy that could be enhanced in combination with incretin therapies. —Dr. Rubin's oral presentation will show that in mouse models of diabetic obesity, APJ agonist monotherapy reduced HbA1c to levels comparable to lean controls and improved glucose tolerance by 25%. When combined with an incretin, APJ agonism further improved glycemic control compared to the incretin alone. Currently, fewer than half of patients with type 2 diabetes achieve optimal glycemic control on current incretin therapies. — Dr. Yan's poster will show that in a mouse model of obesity-associated heart failure, APJ agonist monotherapy reduced cardiac hypertrophy and suppressed markers of cardiac injury. Combination of APJ agonism with an incretin provided enhanced cardioprotective benefits and greater weight loss compared to either treatment alone. Over half of heart failure patients have preserved ejection fraction, and approximately two-thirds of these patients have obesity. Current therapeutic options for obesity-associated HFpEF remain limited. Oral presentation: Saturday Jun 21, 2025 5:00 PM - 5:15 PM CDTTitle: An Oral Apelin Receptor Agonist Enhances Glycemic Control in Preclinical Models of Diabetic Obesity Both as Monotherapy and in Combination with TirzepatideSession: Early Phase, Post Hoc, and Subgroup Analyses from Clinical Trials Testing Incretin-Based Therapies—Take 1; W181 A-CPresenter: Paul Rubin, MD, Chief Medical Officer and EVP-Research Poster presentation: Sunday Jun 22, 2025 12:30 PM - 1:30 PM CDTTitle: The Apelin Receptor Agonist Azelaprag Shows Cardioprotective Effects as Monotherapy and Enhanced Benefits with Semaglutide in a Diet-Induced Obesity Model of Heart Failure with Preserved Ejection FractionSession: Poster Hall F1, Board No. 866Presenter: Shijun Yan, PhD, MBA, Senior Scientist, In Vivo Biology The visual materials for the presentations will be made available on the BioAge investor website concurrent with the beginning of their respective sessions. 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. IND submission and initiation of a Phase 1 SAD/MAD trial are planned for mid-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, including BGE-102 and our APJ program, 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 our IND filing for BGE-102 or our APJ program, our ability to obtain and maintain regulatory approvals, the clinical utility of our product candidates or their ultimate ability to treat human disease, the expected timeline for completing proteomic analysis, anticipated analytical results and the potential for identifying novel therapeutic targets, 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 Chris Patil, media@ IR: Dov Goldstein, ir@ Partnering: partnering@ Web:
Yahoo
30-05-2025
- Business
- Yahoo
BioAge Labs, Inc. (BIOA)'s BGE-102 Shows Potent Weight Loss, Plans IND Submission Mid-2025
BioAge Labs, Inc. (NASDAQ:BIOA), a clinical-stage biotech innovator, announced today the completion of IND-enabling studies for its groundbreaking oral NLRP3 inhibitor, BGE-102, targeting obesity. The company plans to submit an Investigational New Drug (IND) application by mid-2025, with first Phase 1 single ascending dose (SAD) data expected by year-end. A scientist in a lab coat analyzing samples from a petri dish, studying the effects of a potential drug candidate. BGE-102, an internally discovered compound, is distinguished by its novel binding site, high potency, and brain penetration. In preclinical obesity models, BGE-102 delivered dose-dependent weight loss comparable to leading GLP-1 agonist semaglutide, achieving up to 15% reduction as monotherapy and over 20% when combined with semaglutide. The drug also improved insulin sensitivity and demonstrated a robust safety margin in toxicology studies. BioAge Labs, Inc. (NASDAQ:BIOA)'s CEO, Kristen Fortney, Ph.D., highlighted BGE-102's potential as a once-daily oral therapy, either alone or with GLP-1 receptor agonists, by targeting the NLRP3 inflammasome, a key driver of inflammation and metabolic dysfunction in obesity. Pending IND clearance, BioAge Labs, Inc. (NASDAQ:BIOA) will launch Phase 1 trials, with a Phase 1b proof-of-concept study in obesity planned for late 2026. While we acknowledge the potential of BIOA to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than BIOA and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
27-05-2025
- Business
- Globe and Mail
BioAge Labs to Present at Upcoming Investor Conferences
EMERYVILLE, Calif., May 27, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. (NASDAQ: BIOA) ("BioAge", "the Company"), a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today announced that the Company will participate in the following upcoming investor conferences: • Jefferies Global Healthcare Conference (New York, June 3–5, 2025): Kristen Fortney, PhD, CEO and co-founder, and Dov Goldstein, MD, CFO, will participate in one-on-one meetings. • Goldman Sachs 46th Annual Global Healthcare Conference (Miami, June 9–11, 2025): Kristen Fortney, PhD, CEO and co-founder, and Dov Goldstein, MD, CFO, are scheduled to participate in a fireside chat on Monday, June 9, 2025 at 3:20–3:55 PM EDT, and will participate in one-on-one meetings. To access the live webcast of the presentation, register here. Replays of the webcasts will be available in the investor section of the company's website at and will be archived for 30 days following the presentations. 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.
Yahoo
20-03-2025
- Business
- Yahoo
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 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 Chris Patil, media@ IR: Dov Goldstein, ir@ Partnering: partnering@ Web: LABS, Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share information) For the Year Ended December 31, 2024 2023 Operating expenses: Research and development $ 59,036 $ 33,886 General and administrative 19,158 14,514 Total operating expenses 78,194 48,400 Loss from operations (78,194 ) (48,400 ) Other income (expense), net: Interest expense (2,367 ) (7,794 ) Interest and other income (expense), net 9,629 2,431 Changes in fair value of warrants and derivative liabilities 73 (10,091 ) Loss on extinguishment of debt (250 ) — Total other income (expense), net 7,085 (15,454 ) Net loss $ (71,109 ) $ (63,854 ) Net loss per share attributable to common stockholders, basic and diluted $ (6.63 ) $ (38.17 ) Weighted-average common shares outstanding, basic and dilutive 10,726,521 1,672,793 Comprehensive loss: Net loss (71,109 ) (63,854 ) Foreign currency translation adjustment 81 (3 ) Total comprehensive loss $ (71,028 ) $ (63,857 ) BIOAGE LABS, Consolidated Balance Sheets(in thousands, except share and per share information) December 31, December 31, 2024 2023 Assets Current Assets: Cash and cash equivalents $ 354,349 $ 21,644 Restricted cash — 3,313 Prepaid expenses and other current assets 2,754 349 Total current assets 357,103 25,306 Investments 100 100 Property and equipment, net 591 323 Operating lease right-of-use assets 200 195 Other Assets 240 — Total assets $ 358,234 $ 25,924 Liabilities Current Liabilities: Accounts payable $ 1,996 $ 1,866 Accrued expenses and other current liabilities 11,751 7,938 Current portion of term loan 6,000 6,000 Operating lease liabilities, current 202 194 Convertible promissory notes — 20,674 Convertible promissory notes embedded derivative liability — 18,183 Deferred grant income — 3,313 Deferred revenue, current 7,826 — Total current liabilities 27,775 58,168 Deferred revenue 4,674 — Term loan 2,502 8,201 Warrant liability 156 229 Total liabilities 35,107 66,598 Redeemable convertible preferred stock, par value of $0.00001, no shares issued and outstanding as of December 31, 2024; 31,634,362 shares authorized as of December 31, 2023, and 31,465,128 shares issued and outstanding as of December 31, 2023; aggregate liquidation preference of $131,864 as of December 31, 2023 — 132,722 Stockholders' Equity (Deficit) Preferred stock, $0.00001 par value; 10,000,000 shares authorized as of December 31, 2024; no shares issued and outstanding as of December 31, 2024; no shares authorized, issued, or outstanding as of December 31, 2023 — — Common stock, $0.00001 par value; 500,000,000 and 52,400,000 shares authorized as of December 31, 2024 and December 31, 2023, respectively; 35,850,037 and 1,673,314 shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively — — Additional paid-in-capital 575,693 8,142 Accumulated other comprehensive income 245 164 Accumulated deficit (252,811 ) (181,702 ) Total stockholders' equity (deficit) 323,127 (173,396 ) Total liabilities, redeemable convertible preferred stock, and stockholders' equity (deficit) $ 358,234 $ 25,924 Sign in to access your portfolio
