BioAge Labs Files 8-K Report

TL;DR

BioAge Labs filed an 8-K, likely with updates. Check for details.

AI Summary

On December 4, 2025, BioAge Labs, Inc. filed an 8-K report. The filing primarily concerns Regulation FD disclosures, other events, and financial statements and exhibits. No specific financial figures or new material events were detailed in the provided excerpt.

Why It Matters

This 8-K filing indicates BioAge Labs, Inc. is providing updates to the SEC, which could include material information relevant to investors.

Risk Assessment

Risk Level: low — The filing is a standard 8-K report without immediate indication of significant negative events or financial distress.

Key Players & Entities

• BioAge Labs, Inc. (company) — Registrant
• December 04, 2025 (date) — Date of earliest event reported
• Emeryville, California (location) — Principal Executive Offices

FAQ

Key Financial Figures

• $0.00001 — nge on which registered Common Stock, $0.00001 Par Value Per Share BIOA Nasdaq Glo

Filing Documents

• bioa-20251204.htm (8-K) — 67KB
• bioa-ex99_1.htm (EX-99.1) — 35KB
• img161644396_0.jpg (GRAPHIC) — 74KB
• 0001193125-25-307541.txt ( ) — 322KB
• bioa-20251204.xsd (EX-101.SCH) — 25KB
• bioa-20251204_htm.xml (XML) — 5KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On December 4, 2025, BioAge Labs, Inc. (the " Company ") issued a press release announcing positive interim data from its ongoing Phase 1 single ascending dose (SAD) / multiple ascending dose (MAD) clinical trial evaluating BGE-102 a potent, structurally novel, orally available, brain-penetrant small molecule NLRP3 inhibitor being developed for treatment of patients with cardiovascular risk factors. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K. The information furnished in this Item 7.01, including Exhibit 99.1, shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the " Exchange Act "), or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the " Securities Act "). The information contained in this Item 7.01 and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any other filing under the Exchange Act or under the Securities Act, except as shall be expressly set forth by specific reference in such filing.

01 Other Events

Item 8.01 Other Events. Phase 1 Data for BGE-102 On December 4, 2025, the Company announced positive interim data from its ongoing Phase 1 single ascending dose (SAD) / multiple ascending dose (MAD) clinical trial evaluating BGE-102 a potent, structurally novel, orally available, brain-penetrant small molecule NLRP3 inhibitor being developed for treatment of patients with cardiovascular risk factors. BGE-102 was well-tolerated in SAD and initial MAD cohorts, with a pharmacokinetic profile supporting once-daily oral dosing. o BGE-102 treatment was well tolerated across all dose levels evaluated to date in SAD (10, 30, 60, and 120 mg) and MAD (60 and 120 mg) cohorts. o Adverse events were infrequent and mild to moderate in severity, and all resolved without intervention; full analysis to follow after database lock and unblinding in the first half of 2026. BGE-102 achieved 90-98% suppression of IL-1, a cytokine directly downstream of NLRP3, at Day 14 showing strong target engagement. BGE-102 doses of 60 mg and higher exceeded target IC90 levels in cerebrospinal fluid (CSF) at Day 14 demonstrated high brain penetration. Expansion of the Phase 1 trial to include MAD cohorts in participants with obesity and elevated hsCRP, with data anticipated in first half of 2026. Anticipated Milestones 1H26: Completion of Phase 1 MAD cohorts in obese participants with elevated hsCRP, evaluating changes in key inflammatory biomarkers including hsCRP and IL-1. 1H26 : Initiation of Phase 2a proof-of-concept study in patients with obesity and cardiovascular risk factors. o The trial is planned to enroll approximately 100 patients randomized 1:1 to placebo or BGE-102 monotherapy for 12 weeks. The anticipated primary endpoint of the trial is percent change in hsCRP. Additionally, the trial will assess a range of inflammatory and metabolic biomarkers, and perform MRI imaging. 2H26 : Phase 2a data readout.

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press release issued by BioAge Labs, Inc. dated December 4, 2025 . 104 Cover Page Interactive Data File (embedded within the Inline XBRL document). Cautionary Note Regarding Forward-Looking Statements This Current Report on Form 8-K contains "forward-looking statements" within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the Company's plans to develop and commercialize its product candidates, including BGE-102, the potential for BGE-102 as a treatment for cardiovascular risk and the expected timeline for future data readouts from our ongoing Phase 1 clinical trial. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "potential," "possible," "will," "would," and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: the Company's ability to develop, obtain regulatory approval for and commercialize its product candidates; the timing and results of preclinical studies and clinical trials; the risk that positive results in a clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; risks associated with clinical trials, including its ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additio

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. BIOAGE LABS, INC. Date: December 4, 2025 By: /s/ Dov Goldstein Dov Goldstein, M.D. Chief Financial Officer

View Full Filing

View this 8-K filing on SEC EDGAR