Core Viewpoint - The European Commission has referred the marketing authorization application for lecanemab to the Appeal Committee, following a positive opinion from the Committee for Medicinal Products for Human Use in February 2025 [1][6]. Company Overview - BioArctic AB is a Swedish biopharma company focused on innovative treatments for neurodegenerative diseases, including Alzheimer's disease [9]. - BioArctic developed lecanemab in collaboration with Eisai, which is responsible for clinical development and commercialization globally [3][9]. - BioArctic holds rights to commercialize lecanemab in the Nordic region and is preparing for joint commercialization with Eisai [3][8]. Product Information - Lecanemab (Leqembi) is a humanized IgG1 monoclonal antibody targeting amyloid-beta aggregates, approved in multiple markets including the U.S., Japan, and China for mild cognitive impairment and mild Alzheimer's dementia [5][6]. - The approval process in the EU will apply to all 27 member states, as well as Iceland, Liechtenstein, and Norway [2]. Clinical Development - The positive opinion for lecanemab's approval was based on Phase 3 data from the Clarity AD clinical trial, which met its primary and secondary endpoints with statistically significant results [6]. - Ongoing studies include the AHEAD 3-45 trial for individuals with preclinical Alzheimer's disease, fully recruited in October 2024, and the Tau NexGen study for Dominantly Inherited Alzheimer's Disease [7]. Collaboration Details - BioArctic and Eisai have collaborated since 2005, with key agreements for the development and commercialization of lecanemab signed in 2007 and 2015 [8]. - BioArctic incurs no development costs for lecanemab and is entitled to payments related to regulatory approvals and sales milestones [8].

Core Viewpoint - Eisai's simulation predicts Leqembi sales will reach JPY 250 to 280 billion for FY 2027, ending in March 2028 [1] Company Overview - BioArctic AB is a Swedish biopharma company focused on innovative treatments for neurodegenerative diseases, including Alzheimer's disease [8] - BioArctic developed Leqembi (lecanemab) in collaboration with Eisai, which is responsible for global commercialization and regulatory interactions [8] Product Information - Lecanemab is a humanized IgG1 monoclonal antibody targeting amyloid-beta aggregates, approved in multiple countries for mild cognitive impairment and mild Alzheimer's dementia [2][3] - A supplemental Biologics License Application for less frequent intravenous dosing was approved by the FDA in January 2025, with a new subcutaneous auto-injection formulation under review [4] Clinical Trials - Eisai's ongoing Phase 3 study (AHEAD 3-45) targets individuals with preclinical Alzheimer's disease and was fully recruited in October 2024 [5] - The Tau NexGen clinical study for Dominantly Inherited Alzheimer's Disease is also ongoing, utilizing lecanemab as a key therapy [5] Collaboration Details - BioArctic and Eisai have collaborated since 2005, with significant agreements for the development and commercialization of lecanemab [6][7] - BioArctic retains rights to commercialize lecanemab in the Nordic region and incurs no development costs, receiving milestone payments and royalties on global sales [7]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-42279 BIOAGE LABS, INC. (Exact name of Registrant as specified in its Charter) (State or other jurisdiction of incorporation or organ ...

[Business Highlights and Pipeline Update](index=1&type=section&id=Business%20Highlights%20and%20Pipeline%20Update) BioAge provides updates on its APJ agonist and NLRP3 inhibitor programs, alongside new strategic collaborations [APJ Agonists Program Update](index=1&type=section&id=APJ%20agonists%3A%20azelaprag%20discontinued%3B%20Company%20continues%20to%20advance%20next-gen%20agonists) BioAge discontinued its azelaprag Phase 2 trial for obesity due to liver transaminitis, but is developing new APJ agonists - The STRIDES Phase 2 clinical trial for azelaprag in combination with tirzepatide for obesity was discontinued in December 2024[3](index=3&type=chunk) - The discontinuation was due to observations of unexpected liver transaminitis in patients, a risk not predicted by prior Phase 1 or toxicology studies[3](index=3&type=chunk)[4](index=4&type=chunk) - BioAge is continuing to develop next-generation APJ agonists for obesity that are structurally different from azelaprag[4](index=4&type=chunk) [NLRP3 Inhibitor Program: BGE-102](index=2&type=section&id=NLRP3%20inhibitors%3A%20progression%20of%20BGE-102%2C%20with%20initial%20clinical%20data%20expected%202H25) BioAge nominated BGE-102, a brain-penetrant NLRP3 inhibitor, as a candidate for neuroinflammation, with Phase 1 data expected 2H25 - BGE-102, an oral small-molecule NLRP3 inhibitor with high brain penetration, was nominated as a development candidate in January 2025[8](index=8&type=chunk) - Preclinical models show BGE-102 can induce weight loss both as a monotherapy and in combination with a GLP-1 receptor agonist[8](index=8&type=chunk) - Clinical timeline: Phase 1 SAD data is expected in 2H25, followed by MAD data in 1H26[8](index=8&type=chunk) [Platform and Strategic Collaborations](index=2&type=section&id=Platform%20and%20broader%20pipeline%3A%20Strategic%20collaborations%20with%20Novartis%20and%20Lilly) BioAge established strategic collaborations with Novartis and Lilly to discover drug targets and therapeutic antibodies for age-related diseases - Established a multi-year collaboration with Novartis in December 2024 to discover novel drug targets for age-related diseases[8](index=8&type=chunk) - The Novartis deal includes up to **$20 million** in upfront payments and research funding, with potential for an additional **$530 million** in future milestones[8](index=8&type=chunk) - Announced a strategic collaboration with Lilly in January 2025 to discover two therapeutic antibodies for metabolic aging targets[8](index=8&type=chunk) [Full Year 2024 Financial Performance](index=2&type=section&id=Full%20Year%202024%20Financial%20Performance) BioAge reports a **$71.1 million net loss** for FY2024, with increased R&D expenses and a strong **$354.3 million cash** position [Financial Results Summary](index=2&type=section&id=Full%20Year%202024%20Financial%20Results) BioAge reported a **$71.1 million net loss** in FY2024, driven by increased R&D, ending with **$354.3 million cash** FY 2024 vs FY 2023 Financial Highlights | Metric | FY 2024 | FY 2023 | | :--- | :--- | :--- | | R&D Expenses | $59.0 million | $33.9 million | | G&A Expenses | $19.2 million | $14.5 million | | Net Loss | $71.1 million | $63.9 million | | Net Loss per Share | $6.63 | $38.17 | | Cash & Equivalents (EOY) | $354.3 million | $21.6 million | - The **$25.1 million** increase in R&D expenses was primarily due to a **$22.8 million** increase in costs related to the development and manufacturing of azelaprag for its Phase 2 trial[7](index=7&type=chunk) - The company's cash and cash equivalents of **$354.3 million** are expected to fund operations and capital expenses through 2029[11](index=11&type=chunk) [Unaudited Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=BIOAGE%20LABS%2C%20INC.%20Unaudited%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Total operating expenses increased to **$78.2 million** in 2024, resulting in a **net loss of $71.1 million** or **$6.63 per share** Consolidated Statements of Operations (in thousands) | Line Item | 2024 | 2023 | | :--- | :--- | :--- | | 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) | | Total other income (expense), net | $7,085 | $(15,454) | | **Net loss** | **$(71,109)** | **$(63,854)** | | Net loss per share | $(6.63) | $(38.17) | [Unaudited Consolidated Balance Sheets](index=6&type=section&id=BIOAGE%20LABS%2C%20INC.%20Unaudited%20Consolidated%20Balance%20Sheets) Cash and equivalents surged to **$354.3 million** by Dec 31, 2024, significantly strengthening the balance sheet Consolidated Balance Sheet Highlights (in thousands) | Line Item | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $354,349 | $21,644 | | **Total assets** | **$358,234** | **$25,924** | | **Liabilities & Equity** | | | | Total liabilities | $35,107 | $66,598 | | Total stockholders' equity (deficit) | $323,127 | $(173,396) | [Company and Legal Information](index=3&type=section&id=Company%20and%20Legal%20Information) This section provides an overview of BioAge's focus and important disclaimers regarding forward-looking statements [About BioAge Labs, Inc.](index=3&type=section&id=About%20BioAge%20Labs%2C%20Inc.) BioAge is a clinical-stage biopharmaceutical company developing metabolic disease treatments by targeting aging biology - BioAge is a clinical-stage company focused on developing therapies for metabolic diseases by targeting the biology of aging[12](index=12&type=chunk) - The company's pipeline includes NLRP3 inhibitors, APJ agonists, and other preclinical programs based on its human longevity data platform[12](index=12&type=chunk) [Forward-looking Statements](index=3&type=section&id=Forward-looking%20statements) The report contains forward-looking statements on clinical plans and financial outlook, subject to risks detailed in SEC filings - The report contains forward-looking statements regarding clinical development timelines (e.g., BGE-102), potential benefits of product candidates, collaboration outcomes, and cash runway sufficiency[13](index=13&type=chunk) - These statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations[13](index=13&type=chunk) - Investors are advised to review the "Risk Factors" section in the company's Form 10-K and other SEC filings for a comprehensive understanding of potential risks[14](index=14&type=chunk)

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].