Core Insights - BioAge Labs has entered an option agreement with JiKang Therapeutics to potentially in-license a novel APJ agonist nanobody, enhancing its pipeline for obesity and other metabolic diseases [1][5] - The company has filed a provisional patent for new small molecule APJ agonists that are orally active and highly potent, indicating a strong focus on innovative therapeutic approaches [1][7] Group 1: APJ Agonist Program - Apelin, identified as a therapeutic target, has shown in preclinical studies to significantly enhance weight loss and improve muscle function, suggesting its potential as a pharmacological exercise mimetic [2][4] - BioAge aims to develop both oral and subcutaneous APJ agonists to cater to different segments of the obesity market, with plans to file an Investigational New Drug (IND) application in 2026 [3][4] Group 2: Collaboration with JiKang Therapeutics - The collaboration with JiKang allows BioAge to advance the APJ agonist nanobody into IND-enabling studies, with BioAge holding an exclusive option to license the program [6] - JiKang's nanobody is reported to be at least 10-fold more potent than apelin, indicating a significant advancement in pharmacological properties for treating metabolic diseases [5][6] Group 3: Intellectual Property Expansion - BioAge is rapidly advancing its internal small molecule APJ agonist program, having filed a U.S. provisional patent for a new class of agonists with picomolar potency and favorable drug-like attributes [7][8] - The design of these novel leads is supported by advanced computational modeling and AI initiatives, showcasing the company's commitment to innovative drug development [8] Group 4: Company Overview - BioAge Labs is a clinical-stage biopharmaceutical company focused on developing therapeutic candidates for metabolic diseases by targeting human aging biology [9] - The company's lead product candidate, BGE-102, is a small-molecule NLRP3 inhibitor for obesity, with significant weight loss demonstrated in preclinical models [9]

Core Insights - BioAge Labs, Inc. is advancing its lead product candidate BGE-102, a small-molecule NLRP3 inhibitor, targeting obesity and related metabolic diseases with an IND submission planned for mid-2025 and initial Phase 1 data expected by the end of 2025 [1][9][10] Company Overview - BioAge Labs is a clinical-stage biotechnology company focused on developing therapeutic candidates for metabolic diseases by targeting the biology of human aging [10] - The company has identified NLRP3 as a therapeutic target based on its analysis of human aging cohorts, linking reduced NLRP3 activity to greater longevity [2] Product Development - BGE-102 has shown significant weight loss in preclinical obesity models, achieving approximately 15% weight reduction as monotherapy and over 20% when combined with GLP-1 receptor agonists like semaglutide [3][4] - The compound is characterized by a novel structure with a unique binding site, high potency (2 nM IC90 in human microglia), and favorable pharmacokinetics suggesting once-daily dosing [7][6] - Preclinical studies indicate a favorable safety profile for BGE-102, with a 35–75x safety margin for the predicted human dose and no adverse effects observed in toxicology studies [8] Clinical Milestones - The company plans to initiate a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial following IND clearance, with initial SAD data anticipated by the end of 2025 [9][12] - A Phase 1b proof-of-concept study in obesity is expected to commence in the second half of 2026, contingent on successful Phase 1 results [9]

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against BioAge Labs, Inc. due to a class action complaint related to the company's IPO and alleged breaches of fiduciary duties by its board of directors [1] Group 1: Legal Investigation - A class action complaint was filed against BioAge on January 7, 2024, concerning its registration statement for the IPO held on September 26, 2024 [1] - The investigation focuses on whether BioAge's board of directors has breached their fiduciary duties to the company [1] Group 2: Product and Market Impact - On December 6, 2024, BioAge announced the discontinuation of the STRIDES Phase 2 trial for its lead product candidate, azelaprag, due to safety concerns related to elevated liver transaminase levels [2] - This announcement was unexpected, as BioAge had previously highlighted azelaprag's potential in patients undergoing obesity therapy with incretin drugs during its IPO [2] Group 3: Stock Price Reaction - Following the announcement regarding the discontinuation of the trial, BioAge's stock price fell significantly from $20.09 per share on December 6, 2024, to $4.65 per share on December 7, 2024 [3]

Financial Performance - As of March 31, 2025, the total assets of BioAge Labs, Inc. were $343.8 million, a decrease from $358.2 million as of December 31, 2024[14]. - The company reported collaboration revenue of $1.45 million for the three months ended March 31, 2025, compared to no revenue in the same period of 2024[15]. - Total operating expenses increased to $17.9 million for the first quarter of 2025, up from $12.8 million in the same quarter of 2024, primarily driven by higher research and development costs[15]. - The net loss for the first quarter of 2025 was $12.93 million, slightly lower than the net loss of $12.99 million in the same period of 2024[15]. - Cash and cash equivalents at the end of the first quarter of 2025 were $257.5 million, down from $354.3 million at the end of 2024[20]. - The accumulated deficit increased to $265.7 million as of March 31, 2025, compared to $252.8 million at the end of 2024[25]. - The company incurred net cash used in operating activities of $17.36 million for the first quarter of 2025, compared to $15.67 million in the same period of 2024[20]. - The company reported a net loss of $12.9 million for the three months ended March 31, 2025, compared to a net loss of $13.0 million for the same period in 2024[115]. - The company has incurred significant operating losses since its inception, with net losses of $12.9 million and $13.0 million for the three months ended March 31, 2025 and 2024, respectively, resulting in an accumulated deficit of $265.7 million as of March 31, 2025[196]. Cash and Funding - The company had cash, cash equivalents, and marketable securities totaling $335.1 million as of March 31, 2025, sufficient to fund planned operations for at least one year[25]. - The company expects to finance its cash needs through equity offerings, debt financings, or other capital sources, which may dilute existing stockholders' ownership interests[27]. - The company has raised approximately $559.2 million in gross proceeds since its inception in 2015 through various securities[114]. - Existing cash, cash equivalents, and marketable securities are estimated to be sufficient to fund operations and capital expenses through 2029, although this is based on assumptions that may prove incorrect[159]. - The company has no committed sources of capital and may need to finance cash needs through equity offerings or debt financings, which could dilute existing stockholders' interests[162]. - The company has not yet demonstrated the ability to successfully complete clinical trials or obtain regulatory approvals, which poses significant risks to its business[194]. - Failure to raise adequate capital could significantly harm the company's business, financial condition, and prospects, potentially leading to delays or reductions in research programs[205]. Research and Development - Research and development expenses increased by $1.8 million, from $9.3 million in Q1 2024 to $11.1 million in Q1 2025, primarily due to a $2.7 million increase in direct costs related to other programs[146]. - The company expects to continue incurring net operating losses and anticipates significant increases in research and development expenses, general and administrative expenses, and capital expenditures[115]. - The company expects to incur substantial additional capital expenses as it advances its product candidates, particularly BGE-102, through preclinical and clinical development[201]. - The company plans to submit an IND for BGE-102 in mid-2025 and initiate a Phase 1 clinical trial in the second half of 2025[109]. - The company has terminated the development of azelaprag for obesity in January 2025 due to safety concerns but is advancing a new lead program, BGE-102, a small molecule NLRP3 inhibitor[108][109]. - Research and development expenses are expected to continue increasing substantially as the company progresses BGE-102 and other product candidates toward clinical trials[133]. Collaboration and Revenue Recognition - The company entered into a collaboration agreement with Novartis, which includes potential payments of up to $550 million in research and development milestones[124]. - The company recorded collaboration revenue of $1.5 million under the Novartis Agreement for the three months ended March 31, 2025, with no revenue recognized in the same period of 2024[95]. - Deferred revenue related to the Novartis Agreement was $11.4 million as of March 31, 2025[125]. - The Company evaluates collaboration agreements under ASC 606, which may include upfront license fees, research funding, and milestone payments[45]. - The Company recognizes revenue when performance obligations are satisfied, with deferred revenue classified within current liabilities if expected to be recognized within 12 months[41]. Risks and Challenges - The Company faces risks associated with the biotechnology industry, including regulatory approval uncertainties and dependence on third parties[36]. - The company has not generated any product revenue to date and anticipates incurring additional losses until significant sales can be generated from its products in development[24]. - The company is highly dependent on the successful development and commercialization of its lead product candidate, BGE-102, which is still in early development stages[207]. - Successful commercialization of BGE-102 will depend on various factors, including regulatory approvals and effective marketing strategies[208]. - The company must prioritize development of certain product candidates due to limited resources, which may impact its commercial success[210]. - The company anticipates continued significant losses for the foreseeable future and may never achieve or sustain profitability[196]. Internal Controls and Compliance - The company has identified material weaknesses in its internal control over financial reporting, although it has remediated these issues[197]. - The company does not expect the recent FASB updates on income tax disclosures and expense disaggregation to have a material impact on its consolidated financial statements[49][50]. - The company has no unrecognized tax benefits that would reduce its effective tax rate if recognized[101]. - The company is classified as a "smaller reporting company," with a market value of stock held by non-affiliates less than $700.0 million and annual revenue below $100.0 million[181].

Financial Performance - 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 Q1 2024[11]. - The company reported a total comprehensive loss of $12.9 million for Q1 2025, slightly down from a comprehensive loss of $12.97 million in Q1 2024[16]. - Collaboration revenue for Q1 2025 was reported at $1.451 million, compared to no collaboration revenue in Q1 2024[16]. - Total operating expenses for Q1 2025 were $17.9 million, up from $12.8 million in Q1 2024[16]. Expenses - Research and development expenses increased to $11.1 million for Q1 2025, up from $9.3 million in Q1 2024, reflecting a $1.8 million rise primarily due to a $2.7 million increase in direct costs related to other programs[9]. - General and administrative expenses rose to $6.8 million in Q1 2025, compared to $3.5 million in Q1 2024, with a $3.3 million increase mainly due to a $2.0 million rise in personnel-related expenses[10]. Cash Position - As of March 31, 2025, the company had approximately $335.1 million in cash, cash equivalents, and marketable securities, sufficient to fund operations through 2029[12]. Development and Collaboration - BioAge nominated BGE-102 as its lead development candidate for obesity, with initial Phase 1 data expected in the second half of 2025[4]. - A new strategic collaboration with Lilly ExploR&D was announced to develop therapeutic antibodies targeting novel metabolic aging targets[7]. - The company continues to advance its portfolio of novel APJ agonists for obesity, aiming to nominate a development candidate by the end of 2025[8].

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 ...