BioAge Labs (NASDAQ: BIOA) maps 2026–2027 trial plan for BGE-102 in DME

Rhea-AI Filing Summary

BioAge Labs, Inc. filed a current report describing an indication expansion for its oral NLRP3 inhibitor BGE-102 and outlining upcoming clinical milestones. The company plans to start a Phase 1b/2a proof-of-concept trial in patients with diabetic macular edema (DME) in mid-2026.

In a preclinical DME model, oral BGE-102 showed dose-dependent preservation of retinal vascular integrity, with near-complete protection from vascular leakage and up to 90% preservation of microvascular integrity. BGE-102 has shown favorable tolerability to date in an ongoing Phase 1 trial, alongside robust reductions in inflammatory biomarkers such as hsCRP, IL-6, and IL-1β.

The development plan includes completing the Phase 1 trial with full data in the first half of 2026, starting a Phase 2a proof-of-concept trial in obesity with cardiovascular risk factors in the first half of 2026, initiating the DME Phase 1b/2a trial in mid-2026, and targeting data readouts for the cardiovascular trial in the second half of 2026 and for the DME trial in mid-2027.

Insights

Biotech and clinical development analyst

BGE-102 gains a second major indication with a clear 2026–2027 trial roadmap.

The report highlights BGE-102 moving beyond cardiovascular risk into retinal disease, specifically diabetic macular edema (DME). Preclinical data show oral BGE-102 preserved retinal vascular integrity in a DME model, including near-complete protection from vascular leakage and up to 90% preservation of microvascular integrity, which supports testing in patients.

Clinically, BGE-102 has demonstrated favorable tolerability so far in an ongoing Phase 1 trial, with reductions in inflammatory biomarkers hsCRP, IL-6, and IL-1β. The company sequences its program with a Phase 1 completion and full data readout in the first half of 2026, followed by Phase 2a proof-of-concept trials in obesity with cardiovascular risk factors and in DME starting in 1H 2026 and mid-2026, respectively.

The plan includes a cardiovascular risk trial data readout in the second half of 2026 and DME Phase 1b/2a data in mid-2027. Actual value for investors will depend on whether those studies confirm biomarker improvements and translate into meaningful clinical outcomes in both cardiovascular and retinal settings.

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.

Understanding 8-K Material Events →

0001709941false00017099412026-01-202026-01-20

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 20, 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 20, 2026, BioAge Labs, Inc. (the “Company”) issued a press release announcing indication expansion for oral NLRP3 inhibitor BGE-102, with plans to initiate Phase 1b/2a proof-of-concept clinical trial in patients with diabetic macular edema in mid-2026.

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

Planned proof-of-concept clinical trial in DME

On January 20, 2026, the Company announced indication expansion for oral NLRP3 inhibitor BGE-102.

•Growing preclinical and clinical evidence points to central role of the inflammasome in multiple retinal diseases where inflammation is a key feature, including diabetic macular edema (“DME”)

oIn a preclinical model 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

•BGE-102 has demonstrated favorable tolerability to date in ongoing Phase 1 trial, with robust reductions in key inflammatory biomarkers including hsCRP, IL-6, and IL-1β

•Proof-of-concept ("POC") trial in DME is designed to demonstrate ocular target engagement, supporting future development across inflammation-driven retinal diseases

Anticipated Clinical Milestones for BGE-102

•1H 2026:

oCompletion of Phase 1 trial with full data readout, including two additional multiple ascending dose cohorts in obese participants with elevated hsCRP

oInitiation of Phase 2a POC trial in patients with obesity and cardiovascular (“CV”) risk factors

•Mid-2026:

oInitiation of Phase 1b/2a POC trial in patients with DME

•2H 2026:

oCV risk Phase 2a POC trial data readout

•Mid-2027:

oDME Phase 1b/2a POC trial 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 20, 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 and retinal diseases, including DME, 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 20, 2026	By:	/s/ Dov Goldstein
			Dov Goldstein, M.D. Chief Financial Officer

FAQ

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

BioAge Labs announced an indication expansion for its oral NLRP3 inhibitor BGE-102, with plans to initiate a Phase 1b/2a proof-of-concept clinical trial in patients with diabetic macular edema (DME) in mid-2026, and outlined additional planned clinical milestones through mid-2027.

What preclinical results for BGE-102 in diabetic macular edema did BioAge Labs report?

In a preclinical DME model, oral BGE-102 showed dose-dependent preservation of retinal vascular integrity, achieving near-complete protection from vascular leakage and up to 90% preservation of microvascular integrity, supporting its further development in retinal diseases.

How has BGE-102 performed so far in clinical testing according to BioAge Labs?

BGE-102 has demonstrated favorable tolerability to date in an ongoing Phase 1 trial, with robust reductions in key inflammatory biomarkers including hsCRP, IL-6, and IL-1β, which are associated with systemic inflammation.

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

In the first half of 2026, BioAge Labs expects completion of the Phase 1 trial with a full data readout and initiation of a Phase 2a proof-of-concept trial in patients with obesity and cardiovascular risk factors. In mid-2026, it plans to start a Phase 1b/2a proof-of-concept trial in patients with DME, with data from the cardiovascular trial targeted for the second half of 2026.

When does BioAge Labs expect clinical data from BGE-102 trials in cardiovascular risk and DME?

BioAge Labs anticipates a data readout from the cardiovascular risk Phase 2a proof-of-concept trial in the second half of 2026 and a data readout from the DME Phase 1b/2a proof-of-concept trial in mid-2027, based on the timelines described.

Does this 8-K change any financial guidance or provide earnings data for BioAge Labs?

No financial statements or earnings data are discussed. The report focuses on clinical development plans and timelines for BGE-102, particularly its expansion into diabetic macular edema and cardiovascular risk indications.