Positive BGE-102 Phase 1 data for BioAge Labs (NASDAQ: BIOA) reported

Rhea-AI Filing Summary

BioAge Labs, Inc. reported additional positive interim Phase 1 results for BGE-102, a novel brain-penetrant NLRP3 inhibitor being tested in people with obesity and elevated cardiovascular risk. In the first multiple ascending dose cohort, participants receiving 120 mg once daily showed rapid and marked anti-inflammatory effects, including an 86% reduction in hsCRP at Day 14, with 93% of participants reaching normalized hsCRP levels below 2 mg/L.

BGE-102 also produced significant reductions in IL-6 and fibrinogen, two biomarkers linked to systemic inflammation and cardiovascular events, and was described as well tolerated with a favorable safety profile. The company highlighted a newly issued patent covering additional composition of matter and a novel NLRP3 binding site. Planned milestones include completing the Phase 1 trial and initiating a Phase 2a proof-of-concept study in the first half of 2026, followed by Phase 2a data in the second half of 2026.

Positive

• Strong early biomarker response for BGE-102, with 86% hsCRP reduction at Day 14 and 93% of participants reaching normalized hsCRP levels, alongside reported good tolerability and a new composition-of-matter patent plus a defined Phase 2a development timeline in 2026.

Negative

• None.

Insights

Biotech clinical development analyst

Early BGE-102 data show strong biomarker effects and a clear 2026 plan.

The disclosure centers on interim Phase 1 results for BGE-102, a brain-penetrant NLRP3 inhibitor, in obese individuals with elevated cardiovascular risk markers. The first multiple ascending dose cohort at 120 mg once daily achieved an 86% reduction in hsCRP at Day 14, with 93% of participants reaching hsCRP levels under 2 mg/L. The compound also reduced IL-6 and fibrinogen, both clinically relevant cardiovascular risk biomarkers, while being described as well tolerated.

For an early-stage cardiovascular inflammation asset, this combination of strong biomarker movement and a favorable safety description can be meaningful, though it remains non-registrational data. The issued patent covering additional composition of matter and a novel NLRP3 binding site may help strengthen intellectual property around BGE-102. However, all efficacy signals are biomarker-based in a small Phase 1 setting, and the text notes standard development and regulatory risks that could alter outcomes.

The company outlines a development path: completion of the Phase 1 trial with full data in 1H 2026, initiation of a roughly 100-patient Phase 2a obesity and cardiovascular risk study in 1H 2026, and a Phase 2a data readout in 2H 2026. These milestones, if met, would progressively test whether the biomarker effects translate into a broader inflammatory and metabolic profile in a patient population.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 01/12/2026 - 09:10 AM Learn about SEC filing dates

FAQ

What did BioAge Labs (BIOA) announce about BGE-102 in this 8-K?

BioAge Labs announced additional positive interim Phase 1 data for BGE-102, a brain-penetrant NLRP3 inhibitor, showing large reductions in inflammatory biomarkers in obese individuals with elevated cardiovascular risk.

How much did BGE-102 reduce hsCRP in the Phase 1 study?

BGE-102 achieved an 86% reduction in hsCRP at Day 14, and 93% of participants reached normalized hsCRP levels below 2 mg/L in the first multiple ascending dose cohort.

Were there other biomarker changes reported for BGE-102?

Yes. BGE-102 produced significant reductions in IL-6, a key driver of systemic inflammation and cardiovascular risk, and fibrinogen, an independent predictor of cardiovascular events.

What was said about the safety profile of BGE-102?

The company stated that BGE-102 was well tolerated and had a favorable safety profile in the interim Phase 1 data described.

Does BioAge Labs have patent protection related to BGE-102?

BioAge Labs reported a patent issuance covering additional composition of matter and a novel NLRP3 binding site associated with BGE-102.

What are the next clinical milestones for BGE-102 in 2026?

The company plans to complete the BGE-102 Phase 1 trial with a full data readout in 1H 2026, start a roughly 100-patient Phase 2a proof-of-concept study in obesity with cardiovascular risk factors in 1H 2026, and report Phase 2a data in 2H 2026.

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 12, 2026

BIOAGE LABS, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware			001-42279	47-4721157
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
5885 Hollis Street Suite 370
Emeryville, California				94608
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: 510 806-1445

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.00001 Par Value Per Share		BIOA		Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On January 12, 2026, BioAge Labs, Inc. (the “Company”) issued a press release announcing additional positive interim Phase 1 data for BGE-102, a novel brain-penetrant NLRP3 inhibitor, demonstrating Potential for Best-in-class hsCRP reduction in participants with elevated cardiovascular risk.

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.

Item 8.01 Other Events

Phase 1 Data for BGE-102

On January 12, 2026, the Company announced additional positive interim Phase 1 data for BGE-102, a novel brain-penetrant NLRP3 inhibitor, demonstrating potential for best-in-class hsCRP reduction in participants with elevated cardiovascular risk.

•First BGE-102 multiple ascending dose (“MAD”) cohort completed in obese individuals with elevated hsCRP receiving 120 mg once daily (“QD”); demonstrated rapid and profound reduction in inflammatory markers

•BGE-102 achieved 86% reduction in hsCRP at Day 14, with 93% of participants reaching normalized levels (<2 mg/L)

•BGE-102 demonstrated significant reductions in IL-6, a key driver of systemic inflammation and cardiovascular risk, and fibrinogen, an independent predictor of cardiovascular events

•BGE-102 was well tolerated with a favorable safety profile

•Patent issued covering additional composition of matter and novel NLRP3 binding site

Anticipated Milestones

●1H 2026: Completion of Phase 1 trial with full data readout, including two additional MAD cohorts in obese participants with elevated hsCRP

●1H 2026: Initiation of Phase 2a proof-of-concept study in patients with obesity and cardiovascular risk factors. The trial is planned to enroll approximately 100 patients randomized 1:1 to BGE-102 monotherapy or placebo for 12 weeks. The anticipated primary endpoint is percent change in hsCRP. The trial will also assess inflammatory and metabolic biomarkers, and will include liver MRI

●2H 2026: Phase 2a data readout

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press release issued by BioAge Labs, Inc. dated January 12, 2026.
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 additional information or further studies, or may fail to approve or may delay approval of its drug candidates; the occurrence of adverse safety events; failure to protect and enforce its intellectual property, and other proprietary rights; failure to successfully execute or realize the anticipated benefits of its strategic and growth initiatives; risks relating to technology failures or breaches; its dependence on collaborators and other third parties for the development of product candidates and other aspects of its business, which are outside of the Company’s full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions, including due to the imposition of tariffs and other trade barriers; risks associated with current and potential future healthcare reforms; risks relating to attracting and retaining key personnel; changes in or failure to comply with legal and regulatory requirements, including shifting priorities within the U.S. Food and Drug Administration; risks relating to access to capital and credit markets; and the other risks and uncertainties that are detailed under the heading “Risk Factors” included in the Company’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on November 6, 2025, and Company’s other filings with the SEC filed from time to time. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

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:	January 12, 2026	By:	/s/ Dov Goldstein
			Dov Goldstein, M.D. Chief Financial Officer