IntrinsicIntrinsic

BioAge Labs, Inc.

BIOA
🏢 Pharmaceutical Preparations

Business Operations Summary

BIOAGE LABS, INC. is a clinical-stage biopharmaceutical company focused on developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging. The company's core business model revolves around identifying promising targets based on insights into molecular changes that drive aging, utilizing a proprietary technology platform and differentiated human datasets . Revenue generation is currently through collaboration agreements, with no product sales to date . The primary customer segments are pharmaceutical companies for target discovery collaborations and, in the future, patients with cardiometabolic diseases and ophthalmological conditions.

The company's lead program is BGE-102, a potent, structurally novel, orally available, brain-penetrant small-molecule NLRP3 inhibitor . BGE-102 is being advanced in two therapeutic areas: cardiometabolic disease, specifically atherosclerotic cardiovascular disease (ASCVD) risk reduction, and ophthalmology, with diabetic macular edema (DME) as the initial proof-of-concept indication . In preclinical models of DME, oral BGE-102 demonstrated dose-dependent preservation of retinal vascular integrity, achieving near-complete protection from vascular leakage and up to 90% preservation of microvascular integrity . Beyond BGE-102, BIOAGE LABS is developing novel apelin receptor APJ agonists for obesity, targeting both oral and parenteral administration . These APJ agonists have shown the ability to more than double weight loss induced by a GLP-1R agonist in preclinical obesity models, while also restoring healthy body composition and improving muscle function . The company also has earlier-stage platform-derived programs in collaboration with Eli Lilly and Company (Lilly) and an ongoing target discovery collaboration with Novartis Pharma AG (Novartis) .

For the fiscal year ended December 31, 2025, BIOAGE LABS reported collaboration revenue of $8.995 million , compared to no collaboration revenue in the prior year . Total operating expenses increased to $101.775 million from $78.194 million in 2024 , resulting in a loss from operations of $92.780 million , an increase from $78.194 million in 2024 . The net loss for 2025 was $80.605 million , compared to $71.109 million in 2024 . Interest expense decreased by $1.670 million to $0.697 million in 2025 from $2.367 million in 2024 . Interest and other income, net, increased by $3.457 million to $13.086 million in 2025 from $9.629 million in 2024 . The company reported a gain (loss) from changes in fair value of warrants of $(0.214) million in 2025, compared to $0.073 million in 2024 . Loss on extinguishment of debt was $0 million in 2025 , down from $0.250 million in 2024 . As of December 31, 2025, the company had cash, cash equivalents, and marketable securities of $285.1 million and an accumulated deficit of $333.4 million .

Research and development expenses increased by $14.930 million , or 25% , to $73.966 million in 2025 from $59.036 million in 2024 . This increase was primarily driven by a $24.349 million increase in direct costs related to other programs, largely due to work under the Novartis Agreement and activities for novel apelin receptor APJ agonist programs . Direct costs for the BGE-102 program also increased by $14.407 million due to IND-enabling activities, drug-product manufacturing, and the ongoing Phase 1 SAD/MAD clinical trial . Personnel-related expenses increased by $1.194 million , and allocated facility and other expenses increased by $1.419 million . These increases were partially offset by a $26.439 million reduction in azelaprag direct costs following its termination in January 2025 . General and administrative expenses increased by $8.651 million , or 45% , to $27.809 million in 2025 from $19.158 million in 2024 , mainly due to a $3.9 million increase in personnel-related expenses, a $2.9 million increase in legal fees, and a $1.2 million increase in franchise taxes and insurance .

In January 2025, the company announced the nomination of BGE-102 as its lead program . In December 2025, BGE-102 was announced to be well-tolerated in Single Ascending Dose (SAD) and initial Multiple Ascending Dose (MAD) cohorts, with a pharmacokinetic profile supporting once-daily oral dosing, strong target engagement, and high brain penetration . In January 2026, additional positive interim Phase 1 data for BGE-102 demonstrated an 86% median reduction in hsCRP at Day 14 in obese participants with elevated cardiovascular risk, with 93% of participants achieving hsCRP levels below 2 mg/L . In June 2025, an option agreement was announced with JiKang Therapeutics for a novel APJ agonist antibody, along with the filing of a U.S. provisional patent for novel small molecule APJ agonists . The company also terminated the development of azelaprag in January 2025 due to observations of liver transaminitis in some patients during the STRIDES Phase 2 clinical trial .

Business Outlook & Future Growth Drivers

The company anticipates full Phase 1 SAD/MAD clinical trial results for BGE-102 in the first half of 2026 . Following this, a Phase 2a proof-of-concept trial in patients with obesity and elevated hsCRP is planned to be initiated in the first half of 2026, with results anticipated by 2026 year end . For ophthalmology, a Phase 1b/2a proof-of-concept trial in DME is planned to begin in mid-2026, with results anticipated in mid-2027 . The goal of the DME trial is to demonstrate ocular target engagement, supporting future development across inflammation-driven retinal diseases . The company intends to file the first Investigational New Drug applications (INDs) for an APJ program by 2026 year end .

BGE-102 is a key growth area, with plans to advance it in cardiometabolic disease and ophthalmology. For cardiovascular risk reduction, the planned Phase 2a trial will enroll approximately 160 patients with obesity and elevated hsCRP, with a 12-week treatment period and a primary endpoint of percent change in hsCRP from baseline to Week 12 . This trial aims to confirm and extend the hsCRP and inflammatory biomarker effects observed in Phase 1 and further characterize safety and tolerability over an extended period . For DME, the Phase 1b/2a trial will enroll approximately 90 patients, assessing BGE-102 as an adjunctive therapy to intravitreal anti-VEGF treatment and as a monotherapy . The company believes BGE-102's oral, once-daily administration and brain-penetrant small-molecule nature offer advantages over injectable biologic therapies, potentially enabling broader adoption and fixed-dose combination products .

Another major growth vector is the development of novel apelin receptor APJ agonists for obesity, including both oral small-molecule and parenteral (subcutaneous) administration programs . The company has filed composition of matter intellectual property for novel small molecule APJ agonists with picomolar potency, based on an innovative chemical scaffold . For the parenteral program, an option agreement with JiKang Therapeutics for a novel APJ agonist nanobody was announced in June 2025, with the nanobody demonstrating approximately 10-fold greater agonist potency than native apelin and optimized for subcutaneous administration . The company believes APJ agonism has the potential to transform obesity treatment by increasing weight loss quantity and quality, including improved body composition and tolerability, and that combining APJ agonists with GLP-1R/GIP agonists is a therapeutically rational approach .

The company expects its research and development expenses, general and administrative expenses, and capital expenditures to increase substantially in the foreseeable future . This is due to the progression of BGE-102 into additional clinical trials, the discovery and development of additional product candidates, expansion of intellectual property, manufacturing of preclinical and clinical supplies, and the potential establishment of sales, marketing, and distribution infrastructure if products are approved . The company also anticipates increased expenses associated with being a public company .

As of the filing date, the company estimates that its existing cash, cash equivalents, and marketable securities will be sufficient to fund operations and capital expenses through 2029 . However, this estimate is based on assumptions that may prove incorrect, potentially leading to an earlier exhaustion of capital resources . The company will require additional capital to complete planned preclinical development, advance product candidates into clinical trials, seek regulatory approval, and eventually commercialize any approved product candidates . Future funding may be obtained through equity offerings, debt financings, or other capital sources, including licenses, collaborations, or strategic partnerships . The company has an ATM Facility with Leerink Partners LLC, allowing the sale of common stock with an aggregate offering price up to $75.0 million . In January 2026, the company completed an underwritten public offering, issuing 5,897,435 shares at $19.50 per share for net proceeds of $107.6 million , and in February 2026, issued an additional 884,615 shares from the underwriters' option for net proceeds of $16.2 million .

Major Risk Factors & Challenges

The company faces substantial risks, including its limited operating history as a clinical-stage biopharmaceutical company with no approved products and a history of significant operating losses, totaling an accumulated deficit of $333.4 million as of December 31, 2025 . There is a high dependency on raising substantial additional capital, as current funds are estimated to last through 2029, but this is based on assumptions that may prove wrong, potentially forcing delays or elimination of research and development programs . Drug development is lengthy, expensive, and uncertain, with earlier trial results not predictive of future outcomes, as evidenced by the discontinuation of the azelaprag program in January 2025 due to liver transaminitis observed in Phase 2 . The company relies heavily on third parties for clinical trials and manufacturing, exposing it to risks of delays, increased costs, or failure to meet regulatory requirements, exacerbated by potential supply chain issues and geopolitical uncertainties, such as the BIOSECURE Act impacting Chinese biotechnology manufacturing companies . Intellectual property protection is vital but uncertain, with patent terms potentially insufficient, and challenges to validity or enforceability by third parties, including competitors like Ventyx Biosciences, NodThera, Roche, Merck, Novo Nordisk, AstraZeneca, Neumora, Ventus, Tenvie, Insilico, Brenig, and Zydus for NLRP3 inhibitors, and Structure Therapeutics, Bristol Myers Squibb, APIE Therapeutics and Sanofi, S.A. for APJ agonists , posing significant litigation risks and costs. Market acceptance of any approved products is uncertain, dependent on efficacy, safety, price, and reimbursement, which could be limited by cost-containment measures and legislative changes like the Inflation Reduction Act, potentially allowing HHS to negotiate drug prices and impose rebates . The company is also subject to stringent and evolving data privacy and security obligations, with potential for significant penalties and reputational harm from non-compliance or cyberattacks .

Management Priorities & Sentiments

Management's message to shareholders emphasizes a strategic focus on developing a portfolio of therapies for cardiometabolic disease by targeting the biology of human aging. They highlight the company's platform as providing unique insights into human aging biology, which enabled the identification of NLRP3 and apelin as targets. The three strategic priorities are: first, to apply novel insights into aging biology to build a pipeline of therapeutics for chronic cardiometabolic diseases, expanding both internally and through collaborations with partners like Lilly and Novartis; second, to efficiently advance the lead program, BGE-102, a potent, structurally novel, orally available, brain-penetrant small-molecule NLRP3 inhibitor, in cardiometabolic disease and ophthalmology, with plans to initiate a Phase 2a cardiovascular risk trial in the first half of 2026 and a Phase 1b/2a DME trial in mid-2026; and third, to advance both oral and parenteral apelin receptor APJ agonists as a novel exercise mimetic approach for the treatment of obesity, with the intent to file the first IND for an APJ program by 2026 year end. Management also indicates a willingness to selectively partner product candidates to maximize patient impact and shareholder value, given the large market opportunity for cardiometabolic diseases, with GLP-1R agonists for obesity alone projected to reach $150 billion by 2031 .

References

  1. [1] Item 1, Business — Overview
  2. [2] Item 7, MD&A — Revenue
  3. [3] Item 1, Business — Overview
  4. [4] Item 1, Business — Overview
  5. [5] Item 1, Business — Overview
  6. [6] Item 1, Business — Overview
  7. [7] Item 1, Business — Overview
  8. [8] Item 1, Business — Overview
  9. [9] Item 7, MD&A — Results of Operations Comparison of the Years Ended December 31, 2025 and 2024
  10. [10] Item 7, MD&A — Results of Operations Comparison of the Years Ended December 31, 2025 and 2024
  11. [11] Item 7, MD&A — Results of Operations Comparison of the Years Ended December 31, 2025 and 2024
  12. [12] Item 7, MD&A — Results of Operations Comparison of the Years Ended December 31, 2025 and 2024
  13. [13] Item 7, MD&A — Results of Operations Comparison of the Years Ended December 31, 2025 and 2024
  14. [14] Item 7, MD&A — Results of Operations Comparison of the Years Ended December 31, 2025 and 2024
  15. [15] Item 7, MD&A — Results of Operations Comparison of the Years Ended December 31, 2025 and 2024
  16. [16] Item 7, MD&A — Results of Operations Comparison of the Years Ended December 31, 2025 and 2024
  17. [17] Item 7, MD&A — Results of Operations Comparison of the Years Ended December 31, 2025 and 2024
  18. [18] Item 7, MD&A — Results of Operations Comparison of the Years Ended December 31, 2025 and 2024
  19. [19] Item 7, MD&A — Results of Operations Comparison of the Years Ended December 31, 2025 and 2024
  20. [20] Item 7, MD&A — Results of Operations Comparison of the Years Ended December 31, 2025 and 2024
  21. [21] Item 7, MD&A — Results of Operations Comparison of the Years Ended December 31, 2025 and 2024
  22. [22] Item 7, MD&A — Results of Operations Comparison of the Years Ended December 31, 2025 and 2024
  23. [23] Item 7, MD&A — Results of Operations Comparison of the Years Ended December 31, 2025 and 2024
  24. [24] Item 7, MD&A — Results of Operations Comparison of the Years Ended December 31, 2025 and 2024
  25. [25] Item 7, MD&A — Results of Operations Comparison of the Years Ended December 31, 2025 and 2024
  26. [26] Item 7, MD&A — Results of Operations Comparison of the Years Ended December 31, 2025 and 2024
  27. [27] Item 7, MD&A — Liquidity and Capital Resources
  28. [28] Item 7, MD&A — Liquidity and Capital Resources
  29. [29] Item 7, MD&A — Research and Development Expenses
  30. [30] Item 7, MD&A — Research and Development Expenses
  31. [31] Item 7, MD&A — Research and Development Expenses
  32. [32] Item 7, MD&A — Research and Development Expenses
  33. [33] Item 7, MD&A — Research and Development Expenses
  34. [34] Item 7, MD&A — Research and Development Expenses
  35. [35] Item 7, MD&A — Research and Development Expenses
  36. [36] Item 7, MD&A — Research and Development Expenses
  37. [37] Item 7, MD&A — Research and Development Expenses
  38. [38] Item 7, MD&A — Research and Development Expenses
  39. [39] Item 7, MD&A — Research and Development Expenses
  40. [40] Item 7, MD&A — Research and Development Expenses
  41. [41] Item 7, MD&A — General and Administrative Expenses
  42. [42] Item 7, MD&A — General and Administrative Expenses
  43. [43] Item 7, MD&A — General and Administrative Expenses
  44. [44] Item 7, MD&A — General and Administrative Expenses
  45. [45] Item 7, MD&A — General and Administrative Expenses
  46. [46] Item 7, MD&A — General and Administrative Expenses
  47. [47] Item 7, MD&A — General and Administrative Expenses
  48. [48] Item 7, MD&A — General and Administrative Expenses
  49. [49] Item 1, Business — Overview
  50. [50] Item 1, Business — Overview
  51. [51] Item 1, Business — Overview
  52. [52] Item 1, Business — Overview
  53. [53] Item 1, Business — Overview
  54. [54] Item 1, Business — Overview
  55. [55] Item 1, Business — Overview
  56. [56] Item 1, Business — Overview
  57. [57] Item 1, Business — Overview
  58. [58] Item 1, Business — Overview
  59. [59] Item 1, Business — Our Pipeline
  60. [60] Item 1, Business — Phase 2a proof-of-concept trial in cardiovascular risk
  61. [61] Item 1, Business — Our Pipeline
  62. [62] Item 1, Business — The cardiovascular market opportunity
  63. [63] Item 1, Business — Overview
  64. [64] Item 1, Business — Development strategy and timelines
  65. [65] Item 1, Business — Development strategy and timelines
  66. [66] Item 1, Business — APJ agonism in obesity
  67. [67] Item 7, MD&A — Overview
  68. [68] Item 7, MD&A — Overview
  69. [69] Item 7, MD&A — General and Administrative Expense
  70. [70] Item 7, MD&A — Liquidity and Capital Resources
  71. [71] Item 7, MD&A — Funding Requirements
  72. [72] Item 7, MD&A — Funding Requirements
  73. [73] Item 7, MD&A — Funding Requirements
  74. [74] Item 7, MD&A — Liquidity and Capital Resources
  75. [75] Item 7, MD&A — Liquidity and Capital Resources
  76. [76] Item 7, MD&A — Liquidity and Capital Resources
  77. [77] Item 1A, Risk Factors — Risks Related to Our Financial Position, Limited Operating History and Need for Additional Capital
  78. [78] Item 1A, Risk Factors — Risks Related to Our Financial Position, Limited Operating History and Need for Additional Capital
  79. [79] Item 1A, Risk Factors — Risk Related to Research, Discovery, Development, Regulatory Approval and Commercialization of our Product Candidates
  80. [80] Item 1A, Risk Factors — Risks Related to Our Reliance on Third Parties
  81. [81] Item 1A, Risk Factors — Risks Related to Intellectual Property
  82. [82] Item 1A, Risk Factors — Risks Related to Government Regulation
  83. [83] Item 1A, Risk Factors — Risks Related to Our Business and Operations
  84. [84] Item 1, Business — Our Strategy

Report on May 20, 2026