Latest news with #BioAge
Associated Press
9 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
11 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
21-04-2025
- Business
- Yahoo
BioAge Labs, Inc. (BIOA): A Bull Case Theory
We came across a bullish thesis on BioAge Labs, Inc. (BIOA) on Substack by Ragnarok Research. In this article, we will summarize the bulls' thesis on BIOA. BioAge Labs, Inc. (BIOA)'s share was trading at $3.87 as of April 17th. A biopharmaceutical laboratory with researchers at work analyzing complex molecules. BioAge Labs (BIOA) represents a classic "cigarette butt" investment—an overlooked and beaten-down company that still has a few valuable puffs left. Following the abrupt halt of its STRIDES Phase 2 clinical trial for the obesity drug Azelaprag in December 2024, due to elevated liver enzymes in several patients, shares collapsed by over 76%. This sharp decline led investors to assume the company had no remaining value. However, BioAge retains meaningful worth both in its balance sheet and in the long-term potential of its income statement. The market's overreaction has created a significant mispricing. With limited downside and credible hidden value, it fits the mold of a cigar butt stock—one discarded by the market but still capable of delivering strong returns. The investment case is based on the belief that BioAge's current valuation ignores both its asset base and future income potential, with a price target of $7 per share reflecting its true worth. BioAge Labs, Inc. (BIOA) is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 13 hedge fund portfolios held BIOA at the end of the fourth quarter which was 17 in the previous quarter. While we acknowledge the risk and potential of BIOA as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is more promising than BIOA but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. This article was originally published at Insider Monkey. Sign in to access your portfolio
Associated Press
17-04-2025
- Business
- Associated Press
Grabar Law Office Investigates Claims on Behalf of Long-Term Shareholders of BioAge Labs, Inc. (NASDAQ: BIOA); NAPCO Security Technologies, Inc. (NASDAQ: NSSC); Treace Medical Concepts, Inc. (NASDAQ: TMCI); and Virtu Financial Inc. (NASDAQ: VIRT)
PHILADELPHIA, April 17, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. (NASDAQ: BIOA) If you have held BioAge Labs, Inc. (NASDAQ: BIOA) shares continuously since on or shortly after its September 26, 2024 IPO, you can seek corporate reforms, the return of funds back to the Company, and a court approved incentive award at no cost you. Visit contact Joshua H. Grabar at [email protected] or call 267-507-6085 to learn more. Why? BioAge completed its initial public offering on September 27, 2024, selling 12.65 million shares at $18 per share. However, less than three months later, on December 6, 2024, BioAge announced that it would discontinue the ongoing STRIDES Phase 2 study of its investigational drug candidate azelaprag after liver transaminitis was observed in some subjects receiving azelapgrag. In response to the news, BioAge's stock price declined from $20.09 per share on December 6, 2024 to $4.65 per share on December 7, 2024. Following this news, a federal securities fraud class action complaint was filed in which it is alleged that BioAge and ten of its Officers and Directors made materially false and/or misleading statements in its initial public offering concerning its STRIDES Phase 2 clinical trial and that these investors sustained damages as a result thereof. Specifically, it is alleged that BioAge's final prospectus for its IPO represented the significance and benefits of azelaprag for the treatment of obesity in older adults. Defendants touted BioAge's lead product candidate azelaprag in connection with the Company's ongoing STRIDES with expectations of topline results in 2025. Defendants also mentioned its collaboration with Lilly's Chorus clinical development organization who would be advising and assisting on all aspects of the STRIDES trial design and execution. Defendants further discussed the potential for a second Phase 2 clinical trial combining azelaprag and semaglutide to treat obesity in individuals ages 18 years and older. Therefore, the initial public offering represented to the public that there were no safety concerns and the Company expected top line results and to meet its primary endpoint goals in connection with its STRIDES clinical trial. Contrary to these representations, BioAge discontinued the ongoing STRIDES Phase 2 study of its investigational drug candidate azelaprag after several subjects showed elevated levels of liver enzymes warning of potential organ damage. As a result, Defendants discontinued the clinical trial and halted further enrollment. Given the fact that Defendants failure to disclose the potential for liver transaminitis in any of its previous clinical Phase 1 trials and various preclinical tox studies, Defendants' statements in BioAge's registration statement were allegedly false and/or materially misleading at the time of the initial public offering. What You Can Do Now? Current BioAge shareholders who have held BioAge shares since on or shortly after its September 26, 2024 IPO, can seek corporate reforms, the return of funds back to the company, and a court approved incentive award at no cost to them whatsoever. If you would like to learn more about this matter, you are encouraged to visit contact us at [email protected], or call 267-507-6085. #BioAge $BIOA NAPCO Security Technologies, Inc. (NASDAQ: NSSC) Class Action Survives Motion to Dismiss If you are a Current NAPCO (NASDAQ: NSSC) shareholder who has held NAPCO shares since prior to November 7, 2022, you can seek corporate reforms, the return of funds back to the company, and a court approved incentive award at no cost to you whatsoever. Click here to join or learn more: contact Joshua H. Grabar at [email protected], or call 267-507-6085. Why? Key allegations in a recently filed securities fraud class action complaint have survived a motion to dismiss. That complaint alleges that NAPCO Security Technologies, Inc. (NASDAQ: NSSC), through certain of its officers and directors, made materially false and/or misleading statements and/or failed to disclose that: (1) NAPCO failed to address any material weaknesses with internal controls regarding cost of goods sold ('COGS') and inventory; (2) NAPCO downplayed the severity of material weaknesses regarding their internal controls; (3) NAPCO's unaudited financial statements from September 30, 2022 to the present included 'certain errors' such as overstating inventory and understanding net COGS, resulting in overstated gross profit, operating income and net income for each period; (4) as a result, NAPCO would need to restate its previously filed unaudited financial statements for certain periods; and (5) as a result, Defendants' statements about its business, operations, and prospects, were materially false and misleading and/or lacked a reasonable basis at all relevant times. On April 11, 2025, the federal court determined that key allegations would survive Defendants' motion to dismiss the complaint. In so doing, the Court stated: 'Plaintiffs have adequately stated Exchange Act claims by pleading scienter [knowledge of wrongdoing] through defendants' unusual stock sales and by plausibly alleging loss causation between the corrective announcement and stock price drop. Plaintiffs have also stated Securities Act claims against NAPCO and the underwriter defendants.' 'Taking the well-pleaded facts as true, there is no question that plaintiffs have adequately pled scienter. First, the stock sales were highly unusual in timing and amount. As to amount, the total proceeds of over $108 million from stock sales by the officer defendants weigh in favor of a motive. . . . And the officer defendants sold hefty percentages of their holdings – 48.5% for Soloway and 45.5% for Buchel.' What To Do Now: If you have held NAPCO shares since prior to November 7, 2022, you can seek corporate reforms, the return of funds back to the company, and a court approved incentive award at no cost to you whatsoever. If you would like to learn more about this matter, please visit contact Joshua H. Grabar at [email protected], or call 267-507-6085. Treace Medical Concepts, Inc. (NASDAQ: TMCI) If you have held Treace Medical Concepts (NASDAQ: TMCI) shares continuously since prior to May 8, 2023, you can seek corporate reforms, the return of funds back to the Company, and a court approved incentive award at no cost you. Visit or contact Joshua H. Grabar at [email protected] or call 267-507-6085 to learn more. Why? A recently filed securities class action complaint alleges that, Treace Medical Concepts, Inc. (NASDAQ: TMCI), via certain of its officers, made materially false and/or misleading statements and failed to disclose adverse facts about the Company's business, operations, and prospects. Specifically, the Complaint alleges Defendants failed to disclose that: (1) competition impacted the demand for and utilization of its primary product, the Lapiplasty 3D Bunion Correction System; (2) as a result, Treace Medical's revenue declined, and the Company needed to accelerate its plans to offer a product that served as an alternative to osteotomy (a surgical procedure involving the cutting and realignment of a bone to improve its position or function); and (3) Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis. What You Can Do Now: Current Treace shareholders who have held Treace shares since prior to May 8, 2023, can seek corporate reforms, the return of funds back to the company, and a court approved incentive award at no cost to them whatsoever. If you would like to learn more about this matter, you are encouraged to visit contact us at [email protected], or call 267-507-6085. #Treace $TMCI Virtu Financial Inc. (NASDAQ: VIRT) Class Action Survives Motion to Dismiss: A federal securities fraud class action complaint alleging that Virtu Financial Inc. (NASDAQ: VIRT), and certain of its officers failed to disclose to investors that it had improper safeguards in place for sensitive trader information, has survived a motion to dismiss. Virtu shareholders who have continuously held Virtu shares since prior to November 7, 2018, can seek corporate reforms, the return of funds back to the company, and a court approved incentive award at no cost to them whatsoever. Learn more or join by clicking contact Joshua H. Grabar at [email protected], or call 267-507-6085. WHY: A securities fraud class action complaint alleges that Virtu Financial (NASDAQ: VIRT), via certain of its officers, made false and/or misleading statements and/or failed to disclose that: (i) the Company maintained deficient policies and procedures with respect to its information access barriers; (ii) accordingly, Virtu had overstated the Company's operational and technological efficacy as well as its capacity to block the exchange of confidential information between departments or individuals within the Company; (iii) the foregoing deficiencies increased the likelihood that the Company would be subject to enhanced regulatory scrutiny; and (iv) as a result, Defendants' public statements were materially false and/or misleading at all relevant times. On March 17, 2025, a federal Court determined that key allegations were sufficiently pled to survive defendants' motion to dismiss. According to the Court's Order, 'essentially anyone at Virtu, including its proprietary traders' could directly access this material non-public information from at least January 2018 through April 2019, and to do so, Virtu traders only needed to use a 'widely known and frequently shared username and password.' WHAT YOU SHOULD DO NOW: If you are a current Virtu shareholder who has held Virtu stock since on or before November 7, 2018, you can seek corporate reforms, the return of funds spent defending litigation back to the company, and a court approved incentive award, at no cost to you whatsoever. If you would like to learn more about this matter, you are encouraged visit contact Joshua H. Grabar at [email protected] or call 267-507-6085. $VIRT #VirtuFinancial Attorney Advertising Disclaimer Contact: Joshua H. Grabar, Esq. Grabar Law Office One Liberty Place 1650 Market Street, Suite 3600 Philadelphia, PA 19103 Tel: 267-507-6085 Email: [email protected]
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
