PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited H1 2025 financial statements reveal a net loss of $34.5 million, increased operating expenses, and initial collaboration revenue [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets decreased to $322.1 million due to reduced cash, while liabilities also declined and the accumulated deficit grew to $287.3 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $220,330 | $354,349 | | Marketable securities (current & non-current) | $93,073 | $0 | | Total current assets | $301,697 | $357,103 | | **Total assets** | **$322,148** | **$358,234** | | **Liabilities & Equity** | | | | Total current liabilities | $22,837 | $27,775 | | Total liabilities | $27,367 | $35,107 | | Accumulated deficit | $(287,302) | $(252,811) | | **Total stockholders' equity** | **$294,781** | **$323,127** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported increased net losses of $21.6 million and $34.5 million for the three and six months ended June 30, 2025, primarily due to higher operating expenses Statement of Operations Summary (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $2,412 | $0 | $3,863 | $0 | | Research and development | $19,844 | $10,471 | $30,953 | $19,792 | | General and administrative | $7,339 | $4,798 | $14,127 | $8,290 | | Loss from operations | $(24,771) | $(15,269) | $(41,217) | $(28,082) | | **Net loss** | **$(21,563)** | **$(13,581)** | **$(34,491)** | **$(26,573)** | | Net loss per share | $(0.60) | $(7.94) | $(0.96) | $(15.70) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $37.3 million for H1 2025, with significant cash used in investing for marketable securities and financing for loan payments Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(37,332) | $(31,453) | | Net cash used in investing activities | $(93,629) | $(35) | | Net cash (used in) provided by financing activities | $(3,000) | $165,614 | | **Net (decrease) increase in cash** | **$(134,019)** | **$134,128** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business, liquidity, the Novartis collaboration, term loan, and a pending securities class action lawsuit - The company is a **biopharmaceutical firm** focused on developing therapies for **metabolic diseases** like obesity by targeting the biology of aging[22](index=22&type=chunk) - As of June 30, 2025, the company had an accumulated deficit of **$287.3 million** but believes its current cash, cash equivalents, and marketable securities of **$313.4 million are sufficient to fund operations for at least one year**[25](index=25&type=chunk)[26](index=26&type=chunk) - In December 2024, the company entered into a **collaboration agreement with Novartis**, recognizing **$3.9 million in revenue** for the six months ended June 30, 2025, with potential future milestones up to **$530.0 million**[90](index=90&type=chunk)[92](index=92&type=chunk)[94](index=94&type=chunk) - A **securities class action lawsuit** was filed against the company and its directors/officers on January 7, 2025, alleging false and misleading statements in connection with the IPO[81](index=81&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's metabolic disease focus, increased R&D expenses for H1 2025, and strong liquidity projected to fund operations through 2029 [Overview](index=30&type=section&id=Overview) The company is a biopharmaceutical firm focused on metabolic diseases, with lead programs BGE-102 and APJ agonists, and has accumulated a deficit of $287.3 million - The lead program is **BGE-102**, an oral NLRP3 inhibitor for obesity, with a **Phase 1 clinical trial** planned for H2 2025 and initial data expected by year-end 2025[109](index=109&type=chunk)[110](index=110&type=chunk) - The company is also developing novel oral and parenteral **APJ agonists** for obesity, with plans to **file INDs** for both programs by the end of 2026[111](index=111&type=chunk) - The company has incurred **significant operating losses** since inception, with an **accumulated deficit of $287.3 million** as of June 30, 2025[115](index=115&type=chunk) [Results of Operations](index=39&type=section&id=Results%20of%20Operations) Net loss for H1 2025 increased to $34.5 million, driven by higher R&D and G&A expenses, partially offset by initial collaboration revenue Comparison of Results for the Six Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $3,863 | $0 | $3,863 | 100% | | Research and development | $30,953 | $19,792 | $11,161 | 56% | | General and administrative | $14,127 | $8,290 | $5,837 | 70% | | **Loss from operations** | **$(41,217)** | **$(28,082)** | **$(13,135)** | **47%** | R&D Expense Breakdown for the Six Months Ended June 30 (in thousands) | Program | 2025 | 2024 | $ Change | | :--- | :--- | :--- | :--- | | azelaprag | $2,800 | $7,215 | $(4,415) | | BGE-102 | $5,158 | $0 | $5,158 | | Other programs | $10,626 | $2,078 | $8,548 | | Indirect costs | $12,369 | $10,499 | $1,870 | | **Total R&D** | **$30,953** | **$19,792** | **$11,161** | - The increase in G&A expenses was primarily driven by a **$3.5 million increase in personnel-related costs** (largely stock-based compensation) and a **$1.4 million increase in legal fees**[154](index=154&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company held $313.4 million in liquidity, projected to fund operations through 2029, with significant cash used in operations and investing activities - The company possessed **$313.4 million in cash, cash equivalents, and marketable securities** as of June 30, 2025[156](index=156&type=chunk) - Based on the current operating plan, existing cash is estimated to be **sufficient to fund operations and capital expenses through 2029**[166](index=166&type=chunk) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(37,332) | $(31,453) | | Net cash used in investing activities | $(93,629) | $(35) | | Net cash (used in) provided by financing activities | $(3,000) | $165,614 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=52&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is exempt from providing quantitative and qualitative market risk disclosures - As a smaller reporting company, **BioAge Labs is exempt from providing quantitative and qualitative disclosures about market risk**[191](index=191&type=chunk) [Item 4. Controls and Procedures](index=52&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting - Management concluded that the company's **disclosure controls and procedures were effective** as of the end of the period covered by the report (June 30, 2025)[192](index=192&type=chunk) - **No changes in internal control over financial reporting** occurred during the quarter that materially affected, or are reasonably likely to materially affect, these controls[193](index=193&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=53&type=section&id=Item%201.%20Legal%20Proceedings) The company is subject to a securities class action lawsuit filed January 7, 2025, alleging IPO-related violations, which it intends to vigorously defend - A **securities class action lawsuit** was filed against the company on January 7, 2025, alleging false and misleading statements in connection with its initial public offering[81](index=81&type=chunk) [Item 1A. Risk Factors](index=53&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including limited operating history, ongoing losses, capital needs, clinical development uncertainties, third-party reliance, and intense market competition - The company has a history of **significant operating losses** (**$287.3 million accumulated deficit** as of June 30, 2025) and will require substantial additional capital to finance operations[203](index=203&type=chunk)[208](index=208&type=chunk) - The business is highly dependent on the **successful development and commercialization of its lead product candidate, BGE-102**, which is in early development and faces an uncertain clinical and regulatory pathway[214](index=214&type=chunk) - The company relies on **third-party manufacturers in China and India**, exposing it to geopolitical risks, supply chain disruptions, and potential impacts from legislation like the BIOSECURE Act[308](index=308&type=chunk)[309](index=309&type=chunk) - The company is subject to a **securities class action lawsuit**, which could result in substantial costs and divert management's attention[428](index=428&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=130&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered equity sales and detailed the use of $217.2 million net proceeds from its September 2024 IPO and concurrent private placement Use of Proceeds from September 2024 Offerings | Offering | Gross Proceeds | Net Proceeds | | :--- | :--- | :--- | | Initial Public Offering | $227.7 million | $207.3 million | | Concurrent Private Placement | $10.6 million | $9.9 million | | **Total** | **$238.3 million** | **$217.2 million** | [Item 3. Defaults Upon Senior Securities](index=130&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities occurred during the reporting period [Item 4. Mine Safety Disclosures](index=130&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations [Item 5. Other Information](index=130&type=section&id=Item%205.%20Other%20Information) No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted or terminated by directors or officers during the quarter [Item 6. Exhibits](index=131&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including CEO/CFO certifications and Inline XBRL data files

[Business Highlights and Updates](index=1&type=section&id=Business%20Highlights%20and%20Updates) BioAge achieved significant Q2 2025 milestones, advancing its clinical pipeline, expanding APJ agonist programs, and enhancing discovery capabilities [NLRP3 Inhibitor Program (BGE-102)](index=1&type=section&id=NLRP3%20Inhibitor%20Program%20%28BGE-102%29) BioAge completed IND-enabling studies for BGE-102, an oral NLRP3 inhibitor for obesity, with Phase 1 trials starting H2 2025 - BGE-102, an oral NLRP3 inhibitor for obesity, completed IND-enabling studies and demonstrated significant preclinical weight loss, both as a monotherapy and in combination with semaglutide[3](index=3&type=chunk) - A Phase 1 SAD/MAD clinical trial is planned for the second half of 2025, with initial single ascending dose (SAD) data expected by year-end[2](index=2&type=chunk)[3](index=3&type=chunk) [APJ Agonist Pipeline Expansion](index=1&type=section&id=APJ%20Agonist%20Pipeline%20Expansion) BioAge expanded its APJ agonist pipeline through an exclusive option agreement and a new U.S provisional patent filing - Entered into an exclusive option agreement with JiKang Therapeutics for a novel APJ agonist nanobody that shows at least **10-fold greater potency** than apelin, the natural ligand[7](index=7&type=chunk) - Filed a U.S provisional patent application for a new class of orally active, chemically distinct APJ agonists with **picomolar potency** and favorable drug-like properties[7](index=7&type=chunk) [Discovery Platform Expansion](index=2&type=section&id=Discovery%20Platform%20Expansion) BioAge partnered with HUNT Biobank to profile **17,000+ samples**, securing exclusive access to molecular data for drug discovery - Launched an initiative with the HUNT Biobank to profile more than **17,000 samples** from over **6,000 participants**, generating **millions of molecular measurements**[4](index=4&type=chunk) - BioAge has **exclusive access** to the data generated from this partnership for drug discovery purposes[4](index=4&type=chunk) [Strategic Partnerships](index=2&type=section&id=Strategic%20Partnerships) BioAge advanced strategic collaborations with Novartis and Lilly ExploR&D for aging and metabolic disease targets - Continued the multi-year research collaboration with Novartis, announced in December 2024, to discover novel therapeutic targets at the intersection of aging biology and exercise physiology[8](index=8&type=chunk) - Progressed the strategic collaboration with Lilly ExploR&D, announced in January 2025, for the development of therapeutic antibodies targeting novel metabolic aging targets[8](index=8&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) BioAge reported a **net loss of $21.6 million** in Q2 2025 due to increased expenses, with **$313.4 million** cash, sufficient through 2029 [Key Financial Performance](index=2&type=section&id=Key%20Financial%20Performance) Q2 2025 saw R&D expenses rise to **$19.8 million** and G&A to **$7.3 million**, resulting in a **net loss of $21.6 million** Q2 2025 vs Q2 2024 Financial Highlights | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Research and Development | $19.8M | $10.5M | | General and Administrative | $7.3M | $4.8M | | Total Operating Expenses | $27.2M | $15.3M | | Net Loss | ($21.6M) | ($13.6M) | | Net Loss Per Share | ($0.60) | ($7.94) | - The **$9.3 million** increase in R&D expenses was primarily driven by an **$8.0 million** increase in costs for APJ agonist programs and a **$3.0 million** increase for the BGE-102 program, partially offset by a **$1.7 million** reduction in azelaprag costs[6](index=6&type=chunk) - The **$2.5 million** increase in G&A expenses was mainly due to a **$1.5 million** rise in personnel-related costs from stock-based compensation and a **$0.9 million** increase in legal fees[9](index=9&type=chunk) [Financial Position](index=3&type=section&id=Financial%20Position) As of June 30, 2025, BioAge maintained a strong financial position with **$313.4 million** in cash, sufficient to fund operations through 2029 - The company held approximately **$313.4 million** in cash, cash equivalents, and marketable securities as of June 30, 2025[11](index=11&type=chunk) - Management estimates that the current cash position is sufficient to fund operations and capital expenses through **2029**[11](index=11&type=chunk) Balance Sheet Summary | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total Current Assets | $301.7M | $357.1M | | Total Assets | $322.1M | $358.2M | | Total Liabilities | $27.4M | $35.1M | | Total Stockholders' Equity | $294.8M | $323.1M | [Corporate Information](index=3&type=section&id=Corporate%20Information) BioAge is a clinical-stage biopharmaceutical company focused on metabolic disease therapies, with standard 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 therapies by targeting human aging biology - BioAge is a clinical-stage biopharmaceutical company that targets the biology of human aging to develop therapies for metabolic diseases[12](index=12&type=chunk) - The lead product candidate is BGE-102, an oral NLRP3 inhibitor for obesity, with a Phase 1 trial planned for H2 2025. The company is also developing both injectable and oral APJ agonists for obesity[12](index=12&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section contains standard safe harbor statements, cautioning that projections are subject to significant risks and uncertainties - The press release contains forward-looking statements regarding plans to develop and commercialize product candidates, the timing and results of clinical trials, and the sufficiency of cash reserves[13](index=13&type=chunk) - These statements are subject to risks and uncertainties, including the ability to obtain regulatory approval, potential for adverse safety events, and dependence on collaborators, as detailed in the company's SEC filings[13](index=13&type=chunk)[14](index=14&type=chunk)

Core Insights - BioAge Labs is advancing its clinical pipeline with the oral NLRP3 inhibitor BGE-102, set to initiate Phase 1 trials in the second half of 2025, with initial data expected by year-end [2][3] - The company has expanded its APJ agonist pipeline through a partnership for potent antibodies and has filed patents for novel oral small molecules [2][7] - BioAge is enhancing its discovery platform by profiling over 17,000 samples from the HUNT Biobank, which will generate millions of data points related to human longevity [5] Clinical Pipeline Development - The BGE-102 program has completed IND-enabling studies and has shown significant weight loss in preclinical models, both as a standalone treatment and in combination with semaglutide [3] - The Phase 1 SAD/MAD clinical trial for BGE-102 is planned for the second half of 2025, with initial SAD data anticipated by the end of the year [3][13] APJ Agonist Pipeline Expansion - BioAge entered an exclusive option agreement with JiKang Therapeutics to potentially in-license a novel APJ agonist nanobody, which is reported to have over 10-fold greater potency than apelin [7] - The company has filed a U.S. provisional patent for a new class of orally active APJ agonists with high solubility and metabolic stability [7] Discovery Platform Expansion - BioAge's collaboration with the HUNT Biobank aims to profile over 17,000 samples from more than 6,000 participants, generating extensive molecular measurements over decades [5] - The partnership provides BioAge exclusive access to the data for drug discovery purposes [5] Financial Performance - For Q2 2025, research and development expenses were $19.8 million, up from $10.5 million in Q2 2024, primarily due to increased costs related to licensing and development activities [9] - General and administrative expenses rose to $7.3 million from $4.8 million in the same period last year, driven by higher personnel-related expenses [10] - The net loss for Q2 2025 was $21.6 million, or $0.60 per share, compared to a net loss of $13.6 million, or $7.94 per share, in Q2 2024 [11] Cash Position - As of June 30, 2025, BioAge had approximately $313.4 million in cash, cash equivalents, and marketable securities, which is expected to fund operations through 2029 [12]

BioAge Platform & Collaborations - BioAge is harnessing the biology of human aging to develop new therapies for metabolic diseases[6], leveraging a validated platform with ongoing partnerships with Novartis & Lilly to discover drugs and drug targets[6, 11, 12] - The platform utilizes a large collection of longitudinal human aging data, comprising over 50 million molecular data points and over 10,000 profiles generated[6, 9] BGE-102 (NLRP3 Inhibitor) - BGE-102, an oral NLRP3 inflammasome inhibitor, shows potential as a best-in-class treatment with robust preclinical weight loss as a monotherapy and in combination with incretins[6] - Preclinical data indicates BGE-102 can achieve over 90% IL-1 suppression 24 hours after a single oral dose (10 mpk) in non-human primates, with an estimated equivalent human dose of less than 50 mg QD[40, 41] - In preclinical obesity models, BGE-102 monotherapy resulted in dose-dependent weight loss, and in combination with semaglutide, more than doubled weight loss[49, 52] - BioAge is planning a Phase 1 SAD / MAD with data anticipated by 2025 YE and an obesity POC trial with results expected in H2:2026[6, 33, 65] APJ Agonism - APJ agonism is being developed as an exercise mimetic for obesity, with the potential to double weight loss and fully restore body composition when combined with an incretin in preclinical models[7] - The company is advancing programs for both oral and parenteral administration of APJ agonists, with an IND submission targeted for 2026 YE[7] - Human genetic data from BioAge's platform shows that higher apelin protein levels are associated with preservation of grip strength and longevity[73, 74] Financial Status - BioAge reported a strong balance sheet with $335 million in cash as of March 31, 2025[93]

Core Insights - BioAge Labs, Inc. is advancing apelin receptor (APJ) agonists for treating diabetic obesity and heart failure with preserved ejection fraction (HFpEF), showcasing enhanced glycemic control and cardioprotective effects in preclinical models [1][2][3] Company Developments - BioAge is presenting new preclinical data at the American Diabetes Association's 85th Scientific Sessions, highlighting the potential of APJ agonism in combination with incretin therapy [1][3] - The company is developing both oral small-molecule and long-acting injectable formulations of APJ agonists, with an Investigational New Drug (IND) filing targeted for 2026 [3][7] Research Findings - APJ agonism in preclinical models resulted in approximately double the weight loss compared to GLP-1 receptor agonists, while also restoring body composition and muscle function [2] - In mouse models of diabetic obesity, APJ agonist monotherapy reduced HbA1c to levels comparable to lean controls and improved glucose tolerance by 25% [5] - APJ agonist treatment in obesity-associated heart failure models reduced cardiac hypertrophy and markers of cardiac injury, with enhanced benefits observed when combined with incretin therapies [5] Presentation Details - BioAge's Chief Medical Officer, Dr. Paul Rubin, will present findings on the glycemic control effects of APJ agonists on June 21, 2025, while Dr. Shijun Yan will present data on cardioprotective effects on June 22, 2025 [4][5]

Core Insights - BioAge Labs, Inc. is launching an initiative to analyze over 17,000 samples from the HUNT Biobank in Norway to enhance drug target discovery for aging-related diseases [1][2][3] Company Overview - BioAge is a clinical-stage biotechnology company focused on developing therapeutic candidates for metabolic diseases by targeting human aging biology [5] - The lead product candidate, BGE-102, is an orally available small-molecule NLRP3 inhibitor aimed at obesity, showing significant weight loss in preclinical models [5] Research Initiative - The collaboration with Age Labs AS will profile samples from over 6,000 HUNT participants, generating millions of molecular readouts to expand BioAge's proprietary aging data [2][3] - The analysis will focus on participants with long-term health records, tracking the transition from health to diseases such as cardiometabolic disease (>50% of participants) and cognitive decline (>35%) [3] Data Utilization - Insights from the HUNT profiling will integrate into BioAge's existing discovery platform, which has over 50 million molecular measurements collected over five decades [4] - This initiative aims to accelerate the identification of therapeutic targets that promote physiological resilience against age-related diseases [4]

Summary of BioAge Conference Call Company Overview - **Company**: BioAge - **Focus**: Understanding mechanisms of aging to identify new targets for metabolic diseases [2][5] Key Points Pipeline and Strategy - BioAge is advancing several programs into the clinic, including: - **NLRP3 Inhibitor**: Targeting inflammation linked to obesity and other diseases, with an IND filing expected mid-year and SAD data by year-end [2][12] - **Next Generation Apelin Approach**: Aiming to file IND next year, with both oral and injectable forms [2][12] - Collaborations with **Lilly** and **Novartis** to leverage human data for target discovery [3][7] Collaborations - **Novartis Collaboration**: Focused on novel targets related to aging biology, particularly gene changes induced by exercise [7][10] - **Lilly Collaboration**: Building antibodies against new targets identified from BioAge's data platform [57] Mechanistic Insights - NLRP3 levels increase with age and are linked to obesity and cognitive decline [12][18] - The NLRP3 inhibitor shows potential for weight loss comparable to semaglutide, with additional benefits for cardiovascular health [14][18] Clinical Trials - Phase 1 trial for NLRP3 inhibitor will involve around 100 patients over three months, aiming for a single-digit percentage weight loss as a primary endpoint [20][22] - The trial design includes evaluating biomarkers alongside weight loss [21] Market Opportunity - Oral medications are seen as a potential game-changer due to cost-effectiveness compared to injectables [30][31] - A superior weight loss profile for oral drugs could significantly expand market access [31] Differentiation and Competitive Landscape - BioAge's NLRP3 inhibitor is differentiated by its brain penetration and potency, which are crucial for metabolic indications [33][50] - The company is monitoring competitors like **Ventix** and **Nothera**, focusing on weight loss efficacy as a key differentiator [32][48] Financial Outlook - BioAge has over $330 million in cash, providing a runway of more than three years to achieve upcoming milestones [46] Future Catalysts - Anticipated readouts include SAD data by year-end and obesity trial results in the first half of next year [53] Additional Insights - The aging process is a significant driver of chronic diseases, and BioAge aims to discover new therapeutic targets through its biobank resource [5][6] - The company is optimistic about the potential of NLRP3 inhibitors in treating multiple conditions beyond obesity, including neurodegenerative diseases [36][55] Conclusion BioAge is strategically positioned in the biotechnology sector with a focus on aging biology and metabolic diseases, backed by significant collaborations and a robust pipeline. The upcoming clinical data and market strategies will be critical in determining the company's future success.

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]