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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): August 06, 2025

 

 

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 2.02 Results of Operations and Financial Condition.

On August 6, 2025, BioAge Labs, Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2025. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 2.02, including Exhibit 99.1 attached to this report, 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 2.02 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 9.01 Financial Statements and Exhibits.


(d) Exhibits

 

 

 

 

Exhibit
No.

 Description

99.1

Press release issued by BioAge Labs, Inc. dated August 6, 2025.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).


 


 

 


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:

August 6, 2025

By:

/s/ Dov Goldstein

 

 

 

Dov Goldstein, M.D.
Chief Financial Officer

 


EX-99.1 2 bioa-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

img161644396_0.jpg

 

 

BioAge Labs Reports Second Quarter 2025 Financial Results and Provides Business

Updates

 

Oral NLRP3 inhibitor BGE-102 on track for Phase 1 initiation in 2H 2025 with initial data by year-end

 

Expanded APJ agonist pipeline through option agreement for novel antibody and advancement of proprietary oral small molecules

 

Strengthened discovery platform through molecular profiling of 17,000+ samples from leading European HUNT Biobank

 

EMERYVILLE, Calif.--BioAge Labs, Inc. ("BioAge", “the Company”), a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today provided business updates and reported its second quarter 2025 financial results.

 

“In Q2 2025, BioAge achieved key milestones across our clinical pipeline and discovery platform,” said Kristen Fortney, CEO and co-founder of BioAge. “We completed IND-enabling studies for our potential best-in-class oral NLRP3 inhibitor, BGE-102, positioning us to initiate Phase 1 trials later this year, with initial SAD data expected by year-end. We strengthened our apelin pipeline by securing a partnership for potent APJ agonist antibodies and filing patent applications for novel oral small molecules. We also launched a collaboration with the HUNT Biobank to generate millions of new data points, fueling our analysis of human longevity. I’m proud of our progress as we advance our mission to develop transformative therapies for metabolic diseases.”

 

Second Quarter 2025 Business Highlights

NLRP3 inhibitor program development

In May 2025, BioAge announced the completion of IND-enabling studies for BGE-102, an orally available, brain-penetrant NLRP3 inhibitor being initially developed for obesity. BGE-102 demonstrated significant weight loss in preclinical models both as monotherapy and in combination with the GLP-1 receptor agonist semaglutide. The Company plans to initiate a Phase 1 SAD/MAD clinical trial in the second half of 2025, with initial single ascending dose (SAD) data anticipated by year-end.

APJ agonist pipeline expansion


 

In June 2025, BioAge entered into an exclusive option agreement with JiKang Therapeutics (“JiKang”) to potentially in-license a novel APJ agonist nanobody (single-domain antibody) that demonstrates at least 10-fold greater potency than apelin, the natural ligand of APJ. Under the agreement, BioAge and JiKang will jointly advance the nanobody to the beginning of IND-enabling studies, with BioAge holding an exclusive, pre-negotiated option to license the program for worldwide development and commercialization across all indications.
In May 2025, BioAge filed a U.S. provisional patent application for a new class of orally active, chemically distinct APJ agonists with picomolar potency and drug-like properties including high solubility and metabolic stability.

Discovery platform expansion

In June 2025, BioAge announced the launch of an initiative to comprehensively profile and analyze samples from the HUNT Biobank in Norway through its collaboration with Age Labs AS. BioAge will profile more than 17,000 individual samples from 6,000+ participants to generate millions of molecular measurements tracking the transition from health to disease over decades of lifespan. The Company has exclusive access for drug discovery purposes to data generated by the partnership.

Strategic partnerships

The Company continued to advance its multi-year research collaboration with Novartis, announced in December 2024, focused on discovering novel therapeutic targets at the intersection of aging biology and exercise physiology, with multiple targets under evaluation.
BioAge progressed its strategic collaboration with Lilly ExploR&D, announced in January 2025, for the development of therapeutic antibodies targeting novel metabolic aging targets identified through BioAge's discovery platform.

 

 

Second Quarter 2025 Financial Results

 

Research and development expenses were $19.8 million for the quarter ended June 30, 2025, compared to $10.5 million for the same period in 2024. The $9.3 million increase in research and development expenses was primarily attributable to a $8.0 million increase in direct costs related to licensing, discovery, and development activities related to our novel apelin receptor APJ agonist programs. Additionally contributing to the increase in research and development expenses was a $3.0 million increase in direct costs related to our BGE-102 program associated with IND-enabling activities and drug-product manufacturing. These higher costs were partially offset by a $1.7 million reduction in azelaprag direct costs as development was terminated in January 2025.

General and administrative expenses were $7.3 million for the quarter ended June 30, 2025, compared to $4.8 million for the same period in 2024. The $2.5 million increase was primarily attributable to a $1.5 million increase in personnel-related expenses, which was largely attributable to increased stock-based compensation expense associated with option grants issued to employees, executives, board members and advisors.


 

Additionally, contributing to the increase was a $0.9 million increase in legal fees.

 

Net loss was $21.6 million for the quarter ended June 30, 2025, or $0.60 per weighted-average common share outstanding, basic and diluted, compared to a net loss of $13.6 million, or $7.94 per weighted-average common share outstanding, basic and diluted, for the same period in 2024.

 

As of June 30, 2025, BioAge had approximately $313.4 million in cash, cash equivalents, and marketable securities. Based on our current operating plan, BioAge estimates that existing cash, cash equivalents, and marketable securities will be sufficient to fund operations and capital expenses through 2029.

 

About BioAge Labs, Inc.

 

BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging. The Company's lead product candidate, BGE-102, is a potent, orally available, brain-penetrant small-molecule NLRP3 inhibitor being developed for obesity. BGE-102 has demonstrated significant weight loss in preclinical models both as monotherapy and in combination with GLP-1 receptor agonists. Initiation of a Phase 1 SAD/MAD trial is planned for the second half of 2025, with initial SAD data anticipated by end of year. The Company is also developing long-acting injectable and oral small molecule APJ agonists for obesity. BioAge’s additional preclinical programs, which leverage insights from the Company’s proprietary discovery platform built on human longevity data, address key pathways involved in metabolic aging.

 

 

Forward-looking statements

 

This press release 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 our plans to develop and commercialize our product candidates, the timing and results of our planned clinical trials, risks associated with clinical trials, including our ability to adequately manage clinical activities, the timing of and our ability to obtain and maintain regulatory approvals, the clinical utility of our product candidates, the sufficiency of our cash and cash equivalents, and general economic, industry and market conditions. 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: our ability to develop, obtain regulatory approval for and commercialize our product candidates; the timing and results of preclinical studies and clinical trials; the risk that positive results in a preclinical study or 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 our 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 our drug candidates; the occurrence of adverse safety events; failure to protect and enforce our intellectual property, and other proprietary rights; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; risks relating to technology failures or breaches; our dependence on collaborators and other third parties for the development of product candidates and other aspects of our business, which are outside of our 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 BioAge’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on August 6, 2025, and BioAge’s other filings with the SEC filed from time to time. BioAge 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.

 


Contacts

PR: Chris Patil, media@bioagelabs.com

IR: Dov Goldstein, ir@bioagelabs.com

Partnering: partnering@bioagelabs.com

Web: https://bioagelabs.com


 

BIOAGE LABS, INC.

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share information)

 

 

Three Months Ended

 

 

June 30,

 

 

2025

 

 

2024

 

Collaboration revenue

 

$

2,412

 

 

$

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

$

19,844

 

 

$

10,471

 

General and administrative

 

 

7,339

 

 

 

4,798

 

Total operating expenses

 

 

27,183

 

 

 

15,269

 

Loss from operations

 

 

(24,771

)

 

 

(15,269

)

Other income (expense)

 

 

 

 

 

 

Interest expense

 

 

(201

)

 

 

(443

)

Interest and other income (expense), net

 

 

3,420

 

 

 

2,201

 

Gain (loss) from changes in fair value of warrants

 

 

(11

)

 

 

(70

)

Total other income (expense), net

 

 

3,208

 

 

 

1,688

 

Net loss

 

$

(21,563

)

 

$

(13,581

)

Net loss per share attributable to common stockholders, basic and diluted

 

$

(0.60

)

 

$

(7.94

)

Weighted-average common shares outstanding, basic and dilutive

 

 

35,850,037

 

 

 

1,711,005

 

Comprehensive loss:

 

 

 

 

 

 

Net loss

 

 

(21,563

)

 

 

(13,581

)

Other comprehensive income (loss):

 

 

 

 

 

 

Foreign currency translation adjustment

 

 

(52

)

 

 

(18

)

Total other comprehensive income (loss):

 

 

(52

)

 

 

(18

)

Total comprehensive loss

 

$

(21,615

)

 

$

(13,599

)

 


 

BIOAGE LABS, INC.

Unaudited Condensed Consolidated Balance Sheets

(in thousands, except share and per share information)

 

 

June 30,

 

 

December 31,

 

 

2025

 

 

2024

 

Assets

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

220,330

 

 

$

354,349

 

Marketable securities, current

 

 

76,965

 

 

 

 

Accounts receivable

 

 

603

 

 

 

 

Prepaid expenses and other current assets

 

 

3,799

 

 

 

2,754

 

Total current assets

 

 

301,697

 

 

 

357,103

 

Investments

 

 

100

 

 

 

100

 

Marketable securities

 

 

16,108

 

 

 

 

Property and equipment, net

 

 

974

 

 

 

591

 

Operating lease right-of-use assets, net

 

 

3,032

 

 

 

200

 

Other assets

 

 

237

 

 

 

240

 

Total assets

 

$

322,148

 

 

$

358,234

 

Liabilities

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,329

 

 

$

1,996

 

Accrued expenses and other current liabilities

 

 

7,584

 

 

 

11,751

 

Term loan, current

 

 

5,596

 

 

 

6,000

 

Operating lease liabilities, current

 

 

630

 

 

 

202

 

Deferred revenue, current

 

 

7,698

 

 

 

7,826

 

Total current liabilities

 

 

22,837

 

 

 

27,775

 

Deferred revenue

 

 

1,902

 

 

 

4,674

 

Term loan

 

 

 

 

2,502

 

Warrant liability

 

 

108

 

 

 

156

 

Operating lease liabilities

 

 

2,520

 

 

 

 

Total liabilities

 

 

27,367

 

 

 

35,107

 

Stockholders’ Equity

 

 

 

 

 

 

Preferred stock, $0.00001 par value; 10,000,000 shares authorized as of
  June 30, 2025 and December 31, 2024; no shares issued or outstanding
   as of June 30, 2025 and December 31, 2024

 

 

 

 

 

 

Common stock, $0.00001 par value; 500,000,000 shares authorized as of
  June 30, 2025 and December 31, 2024; 35,850,037 shares issued and outstanding
   as of June 30, 2025 and December 31, 2024

 

 

 

 

 

 

Additional paid-in-capital

 

 

581,871

 

 

 

575,693

 

Accumulated other comprehensive income

 

 

212

 

 

 

245

 

Accumulated deficit

 

 

(287,302

)

 

 

(252,811

)

Total stockholders’ equity

 

 

294,781

 

 

 

323,127

 

Total liabilities and stockholders’ equity

 

$

322,148

 

 

$

358,234