RICHMOND, Calif.--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-founde ...

Core Insights - BioAge Labs is advancing its oral, brain-penetrant NLRP3 inhibitor BGE-102, with initial clinical data expected in the second half of 2025 [1][2] - The company has discontinued the development of its APJ agonist azelaprag due to unexpected liver transaminitis observed in clinical trials [2][4] - BioAge has established strategic collaborations with Novartis and Lilly to discover and develop novel therapies targeting metabolic aging [3][5] Financial Performance - Research and development expenses for the year ended December 31, 2024, were $59.0 million, up from $33.9 million in 2023, primarily due to increased costs associated with the azelaprag development [6] - General and administrative expenses rose to $19.2 million in 2024 from $14.5 million in 2023, mainly due to increased stock-based compensation [7] - The net loss for the year ended December 31, 2024, was $71.1 million, or $6.63 per share, compared to a net loss of $63.9 million, or $38.17 per share, in 2023 [8] Cash Position - As of December 31, 2024, BioAge had approximately $354.3 million in cash and cash equivalents, which is expected to fund operations through 2029 [9] Pipeline Developments - BioAge is progressing with its next-generation APJ agonists while continuing to develop BGE-102, which has shown potential for treating neuroinflammation linked to obesity [2][4] - The collaboration with Novartis includes up to $20 million in upfront payments and research funding, with potential future milestones totaling up to $530 million [3]

Core Points - BioArctic AB has received orphan drug designation from the US FDA for exidavnemab, aimed at treating Multiple System Atrophy (MSA), a rare and fatal disease with no current cure [1][3][7] - Exidavnemab is a monoclonal antibody designed to target and eliminate aggregated alpha-synuclein, potentially slowing the progression of MSA and Parkinson's disease [2][8] - The orphan drug designation provides various incentives, including tax credits for clinical trials and potential seven-year marketing exclusivity upon FDA approval [3] Company Overview - BioArctic AB is a Swedish biopharma company focused on innovative treatments for neurodegenerative diseases, including Alzheimer's and Parkinson's [9] - The company is known for developing Leqembi® (lecanemab), the first drug proven to slow Alzheimer's progression [9] - BioArctic utilizes proprietary technology, such as BrainTransporter™, to enhance drug delivery to the brain [9] Disease Context - MSA is characterized by rapid progression and affects the central and autonomic nervous systems, leading to severe disability and a poor prognosis [6][7] - The disease affects fewer than 42,000 individuals in the U.S., highlighting the high unmet medical need [7] - Patients typically have a life expectancy of 6 to 10 years post-symptom onset, with few surviving beyond 15 years [7]

Core Points - BioArctic AB's founders and CEO have been awarded Uppsala University's Innovation and Entrepreneurship Prize for their contributions to addressing Alzheimer's disease [1][2][8] - The prize recognizes their groundbreaking research and successful commercialization of an academic discovery into an approved drug, lecanemab, which has the potential to significantly impact millions of lives [2][8] Company Overview - BioArctic AB is a Swedish biopharma company focused on innovative treatments for neurodegenerative diseases, particularly Alzheimer's disease [11] - The company is known for developing Leqembi® (lecanemab), the first drug proven to slow the progression of early Alzheimer's disease and reduce cognitive impairment [11] - BioArctic collaborates with Eisai, a Japanese pharmaceutical company, to develop lecanemab and is actively pursuing approvals in multiple countries [6][11] Founders' Vision - The founders, Lars Lannfelt and Pär Gellerfors, aimed to establish BioArctic as a significant pharmaceutical company in Sweden, revitalizing the country's pharmaceutical industry [5] - Lars Lannfelt's research in the 1990s laid the foundation for the development of an antibody to combat Alzheimer's disease, leading to the establishment of BioArctic in 2003 [4][5] Drug Development and Approval - Lecanemab is currently approved in eleven countries, including the USA, Japan, and China, with additional approvals pending in 17 regions, including Europe [6] - The drug represents a significant advancement in the treatment of Alzheimer's disease, with the potential to change the lives of millions [2][11]

Core Viewpoint - A class action lawsuit has been filed against BioAge Labs, Inc. for alleged violations of federal securities laws related to misleading statements made during its IPO and subsequent trial discontinuation announcement [1][2]. Group 1: Lawsuit Details - The lawsuit pertains to BioAge's announcement on December 6, 2024, regarding the discontinuation of its STRIDES Phase 2 trial for azelaprag due to safety concerns, which contradicts earlier claims made during the IPO about the drug's potential in obesity therapy [2]. Group 2: Investor Information - Shareholders who purchased BioAge's securities during the IPO on September 26, 2024, are encouraged to contact the DJS Law Group before March 10, 2025, to participate in the lawsuit [1][3].

Core Viewpoint - Rosen Law Firm is reminding investors who purchased BioAge Labs, Inc. stock during its IPO on September 26, 2024, of the March 10, 2025, deadline to become a lead plaintiff in a class action lawsuit [1] Group 1: Class Action Details - Investors who purchased BioAge stock may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2] - A class action lawsuit has already been filed, and interested parties must move the Court to serve as lead plaintiff by March 10, 2025 [3] - Investors can join the class action by visiting the provided link or contacting the law firm directly for more information [7] Group 2: Law Firm Credentials - Rosen Law Firm emphasizes the importance of selecting qualified counsel with a successful track record in securities class actions [4] - The firm has achieved significant settlements, including the largest securities class action settlement against a Chinese company at the time, and has consistently ranked highly in securities class action settlements [4] Group 3: Case Background - The lawsuit claims that BioAge misrepresented the safety and efficacy of its lead product candidate, azelaprag, during its IPO, stating there were no safety concerns and expecting positive trial results [5] - BioAge discontinued the STRIDES Phase 2 study of azelaprag after subjects showed elevated liver enzyme levels, which were not disclosed in prior trials, leading to claims that the company's statements were false and misleading [6]

Core Viewpoint - A lawsuit has been filed against BioAge Labs, Inc. and its senior executives for potential violations of federal securities laws related to their initial public offering and subsequent disclosures regarding their clinical trials [1][2]. Company Overview - BioAge Labs, Inc. is a clinical-stage biopharmaceutical company focused on developing therapeutic products for metabolic diseases, particularly obesity [3]. Legal Context - The lawsuit claims violations under Sections 11 and 15 of the Securities Act of 1933, specifically concerning the registration statement for BioAge's IPO on September 26, 2024 [2]. - The case is currently pending in the U.S. District Court for the Northern District of California, titled Soto v. BioAge Labs, Inc., et al., No. 25-cv-196 [2]. Clinical Trial Details - BioAge's IPO documents highlighted the ongoing STRIDES Phase 2 trial of its lead product candidate, azelaprag, in combination with GLP-1R agonists for enhanced weight loss, with expectations for topline results in Q3 2025 [4]. - The company claimed collaboration with Eli Lilly and Company for the trial's design and execution, asserting no safety concerns at the time [4]. Trial Discontinuation - The STRIDES Phase 2 trial was discontinued due to safety concerns after subjects exhibited elevated liver enzyme levels, indicating potential organ damage [5]. - BioAge announced the discontinuation on December 6, 2024, leading to a significant stock price decline of over 76%, from $20.09 to $4.65 per share within three days [6].

NEW YORK, March 10, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of BioAge Labs, Inc. (NASDAQ: BIOA).Shareholders who purchased shares of BIOA during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/bioage-labs-inc-loss-submission-form/?id=134581&from=4CLASS PERIOD: This lawsuit is on ...

Group 1 - The Schall Law Firm has filed a class action lawsuit against BioAge Labs, Inc. for violations of federal securities laws related to its IPO on September 26, 2024 [1] - The lawsuit claims that BioAge made false and misleading statements regarding its lead trial candidate, azelaprag, particularly concerning its safety and potential in obesity therapy [4] - The discontinuation of the STRIDES Phase 2 trial due to safety concerns was contrary to the claims made during the IPO, leading to investor damages when the truth was revealed [4] Group 2 - Investors who purchased BioAge's securities during the IPO are encouraged to contact the Schall Law Firm to discuss their rights [2] - The class in this case has not yet been certified, meaning potential class members are not yet represented by an attorney [3] - The Schall Law Firm specializes in securities class action lawsuits and represents investors globally [5]

Core Viewpoint - Rosen Law Firm is reminding investors who purchased BioAge Labs, Inc. stock during its IPO on September 26, 2024, of the March 10, 2025 deadline to become lead plaintiffs in a class action lawsuit [1]. Group 1: Class Action Details - Investors who purchased BioAge stock may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and interested parties must move the Court by March 10, 2025, to serve as lead plaintiff [3]. - The Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions [4]. Group 2: Case Background - The lawsuit alleges that BioAge misrepresented the safety and efficacy of its lead product candidate, azelaprag, in connection with the STRIDES clinical trial, which was expected to yield topline results in 2025 [5]. - BioAge discontinued the STRIDES Phase 2 study after subjects exhibited elevated liver enzyme levels, indicating potential organ damage, which was not disclosed in prior trials [6].