Core Insights - BioAge Labs, Inc. is advancing its clinical-stage pipeline focused on metabolic diseases by targeting human aging biology, with significant progress in its lead candidate BGE-102, a brain-penetrant NLRP3 inhibitor for obesity [2][3] Business Highlights - The nomination of BGE-102 as the lead development candidate for obesity was made in January 2025, showing potential best-in-class potency and targeting diseases driven by neuroinflammation [3] - A strategic collaboration with Lilly was announced to develop therapeutic antibodies targeting novel metabolic aging targets identified through BioAge's discovery platform [3] - The company is progressing its portfolio of novel APJ agonists for obesity, aiming to nominate a development candidate by the end of 2025 [3] Financial Results - Research and development expenses for Q1 2025 were $11.1 million, up from $9.3 million in Q1 2024, primarily due to increased costs related to IND-enabling activities for BGE-102 [4] - General and administrative expenses rose to $6.8 million in Q1 2025 from $3.5 million in Q1 2024, largely due to increased personnel-related expenses and stock-based compensation [5] - The net loss for Q1 2025 was $12.9 million, or $0.36 per share, compared to a net loss of $13.0 million, or $7.76 per share, in the same period of 2024 [7][12] Cash Position - As of March 31, 2025, BioAge had approximately $335.1 million in cash, cash equivalents, and marketable securities, which is expected to fund operations through 2029 [8]

BioAge Labs, Inc. - BioAge Labs completed its IPO on September 27, 2024, selling 12.65 million shares at $18 per share, but the stock price fell significantly after the announcement of discontinuing the STRIDES Phase 2 study due to liver transaminitis observed in subjects [2][4] - Following the discontinuation of the clinical trial, BioAge's stock price dropped from $20.09 on December 6, 2024, to $4.65 on December 7, 2024 [2] - A federal securities fraud class action complaint was filed against BioAge and its officers, alleging that they made materially false and misleading statements regarding the STRIDES Phase 2 clinical trial and failed to disclose safety concerns [3][4] NAPCO Security Technologies, Inc. - A securities fraud class action complaint against NAPCO has survived a motion to dismiss, alleging that the company made materially false statements regarding internal controls and financial statements [7][9] - The complaint claims that NAPCO overstated inventory and net cost of goods sold, leading to inflated gross profit and necessitating a restatement of financial statements [8][9] - The court found that plaintiffs adequately pled claims of wrongdoing based on unusual stock sales by officers, which totaled over $108 million [9] Treace Medical Concepts, Inc. - A securities class action complaint alleges that Treace Medical made false statements regarding its primary product, the Lapiplasty 3D Bunion Correction System, and failed to disclose competition impacts on demand [11] - The complaint indicates that Treace's revenue declined and the company needed to accelerate plans for an alternative product due to competitive pressures [11] Virtu Financial Inc. - A securities fraud class action complaint against Virtu Financial has survived a motion to dismiss, alleging that the company failed to disclose deficiencies in its information access policies [14][15] - The court determined that employees had inappropriate access to sensitive non-public information, which could lead to regulatory scrutiny [16]

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].