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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): May 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

 

1445A South 50th Street Richmond, CA 94804

(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 May 6, 2025, BioAge Labs, Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 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 May 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:

May 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 First Quarter 2025 Financial Results and Provides Business

Updates

 

Advancement of lead candidate BGE-102, an oral, brain-penetrant NLRP3 inhibitor for obesity, with initial clinical data expected 2H25

 

New strategic collaboration with Lilly ExploR&D expands therapeutic approach to novel metabolic aging targets

 

Progression of preclinical next-generation APJ agonists for obesity

 

 

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

 

“The first quarter of 2025 was marked by strategic execution as we advanced our focused pipeline," said Kristen Fortney, Ph.D., CEO and co-founder of BioAge. "We've made significant progress with BGE-102, our brain-penetrant NLRP3 inhibitor, and are on track with IND-enabling studies to bring this potential best-in-class compound to the clinic this year, with initial Phase 1 data expected before year-end. Our new collaboration with Lilly expands our therapeutic capabilities into antibodies while validating our platform-driven approach to targeting the biology of aging. Meanwhile, both our novel APJ agonist program and our partnership with Novartis continue to make meaningful progress. With these scientific advancements and our strong financial position, we're well-positioned to deliver on our mission to leverage the biology of aging to develop transformative treatments for metabolic diseases."

 

 

 

First Quarter 2025 Business Highlights

NLRP3 program development

In January 2025, BioAge nominated BGE-102, a novel, orally available small-molecule NLRP3 inhibitor, as its lead development candidate for obesity. The compound shows potential best-in-class potency and brain penetration, and can target diseases driven by neuroinflammation including metabolic conditions and obesity. In preclinical studies, NLRP3 inhibition has demonstrated significant weight loss potential.

 

IND-enabling studies are currently underway, with initial Phase 1 data anticipated in the second half of 2025.

Strategic collaborations

In January 2025, BioAge announced a strategic collaboration with Lilly ExploR&D to develop two therapeutic antibodies targeting novel metabolic aging targets identified through BioAge's discovery platform.

Pipeline advancement

The Company continues to advance its portfolio of novel, structurally differentiated APJ agonists for obesity and related metabolic conditions, with the goal of nominating a development candidate by the end of 2025. BioAge's multi-year research collaboration with Novartis, focused on discovering novel therapeutic targets at the intersection of aging biology and exercise physiology, continues to make meaningful progress.

 

First Quarter 2025 Financial Results

 

Research and development expenses were $11.1 million for the quarter ended March 31, 2025, compared to $9.3 million for the same period in 2024. The $1.8 million increase in research and development expenses was primarily attributable to a $2.7 million increase in direct costs related to other programs as BioAge focused its research and development activities on IND-enabling activities for BGE-102.

 

General and administrative expenses were $6.8 million for the quarter ended March 31, 2025,, compared to $3.5 million for the same period in 2024. The $3.3 million increase was primarily attributable to a $2.0 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 $0.5 million increase in legal fees, and a $0.4 million increase in taxes and insurance, primarily related to our public-company director and officer insurance policy.

 

Net loss was $12.9 million for the quarter ended March 31, 2025, or $0.36 per weighted-average common share outstanding, basic and diluted, compared to a net loss of $13.0 million, or $7.76 per weighted-average common share outstanding, basic and diluted, for the same period in 2024.

 

As of March 31, 2025, BioAge had approximately $335.1 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 pipeline includes novel, orally available, brain-penetrant small-molecule NLRP3 inhibitors to treat metabolic diseases and conditions driven by neuroinflammation, as well as novel APJ agonists for metabolic disorders.


 

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 May 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

 

 

March 31,

 

 

2025

 

 

2024

 

Collaboration revenue

 

$

1,451

 

 

$

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

$

11,109

 

 

$

9,321

 

General and administrative

 

 

6,788

 

 

 

3,492

 

Total operating expenses

 

 

17,897

 

 

 

12,813

 

Loss from operations

 

 

(16,446

)

 

 

(12,813

)

Other income (expense)

 

 

 

 

 

 

Interest expense

 

 

(255

)

 

 

(1,217

)

Interest and other income (expense), net

 

 

3,714

 

 

 

1,296

 

Gain (loss) from changes in fair value of warrants

 

 

59

 

 

 

(8

)

Loss on extinguishment of debt

 

 

 

 

 

(250

)

Total other income (expense), net

 

 

3,518

 

 

 

(179

)

Net loss

 

$

(12,928

)

 

$

(12,992

)

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

 

$

(0.36

)

 

$

(7.76

)

Weighted-average common shares outstanding, basic and dilutive

 

 

35,850,037

 

 

 

1,673,472

 

Comprehensive loss:

 

 

 

 

 

 

Net loss

 

 

(12,928

)

 

 

(12,992

)

Other comprehensive income:

 

 

 

 

 

 

Unrealized holding gains on available-for-sale investments

 

 

29

 

 

 

 

Foreign currency translation adjustment

 

 

(10

)

 

 

21

 

Total other comprehensive income:

 

 

19

 

 

 

21

 

Total comprehensive loss

 

$

(12,909

)

 

$

(12,971

)

 


 

BIOAGE LABS, INC.

Unaudited Condensed Consolidated Balance Sheets

(in thousands, except share and per share information)

 

 

March 31,

 

 

December 31,

 

 

2025

 

 

2024

 

Assets

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

257,486

 

 

$

354,349

 

Marketable securities, current

 

 

63,032

 

 

 

 

Accounts receivable

 

 

361

 

 

 

 

Prepaid expenses and other current assets

 

 

3,934

 

 

 

2,754

 

Total current assets

 

 

324,813

 

 

 

357,103

 

Investments

 

 

100

 

 

 

100

 

Marketable securities

 

 

14,559

 

 

 

 

Property and equipment, net

 

 

929

 

 

 

591

 

Operating lease right-of-use assets, net

 

 

3,201

 

 

 

200

 

Other assets

 

 

239

 

 

 

240

 

Total assets

 

$

343,841

 

 

$

358,234

 

Liabilities

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

Accounts payable

 

$

3,989

 

 

$

1,996

 

Accrued expenses and other current liabilities

 

 

4,866

 

 

 

11,751

 

Term loan, current

 

 

6,000

 

 

 

6,000

 

Operating lease liabilities, current

 

 

700

 

 

 

202

 

Deferred revenue, current

 

 

8,183

 

 

 

7,826

 

Total current liabilities

 

 

23,738

 

 

 

27,775

 

Deferred revenue

 

 

3,227

 

 

 

4,674

 

Term loan

 

 

1,056

 

 

 

2,502

 

Warrant liability

 

 

97

 

 

 

156

 

Operating lease liabilities

 

 

2,556

 

 

 

 

Total liabilities

 

 

30,674

 

 

 

35,107

 

Commitments and Contingencies (Note 8)

 

 

 

 

 

 

Stockholders’ Equity

 

 

 

 

 

 

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

 

 

 

 

 

 

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

 

 

 

 

 

 

Additional paid-in-capital

 

 

578,642

 

 

 

575,693

 

Accumulated other comprehensive income

 

 

264

 

 

 

245

 

Accumulated deficit

 

 

(265,739

)

 

 

(252,811

)

Total stockholders’ equity

 

 

313,167

 

 

 

323,127

 

Total liabilities and stockholders’ equity

 

$

343,841

 

 

$

358,234