株探米国株
日本語 英語
エドガーで原本を確認する
0001709941false00017099412025-03-202025-03-20

 

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): March 20, 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.)

 

 

 

 

 

1445A South 50th Street

 

Richmond, California

 

94804

(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 March 20, 2025, BioAge Labs, Inc. (the “Company”) issued a press release announcing its financial results for the year ended December 31, 2024. 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 March 20, 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:

March 20, 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 Full Year 2024 Financial Results and Provides Business Updates from the Fourth Quarter of 2024

 

Advancement of oral, brain-penetrant NLRP3 inhibitor BGE-102, with initial clinical data expected 2H25

 

Progression of preclinical next-generation APJ agonists for obesity

 

New platform partnerships with Novartis and Lilly to discover and develop novel therapies for conditions driven by metabolic aging

 

 

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 financial results for the full year ended December 31, 2024 and business updates for the fourth quarter ended December 31, 2024.

 

"The fourth quarter of 2024 was marked by key strategic decisions and solid pipeline progress,” said Kristen Fortney, Ph.D., CEO and co-founder of BioAge. “After careful evaluation of the clinical data for our APJ agonist azelaprag, we made the decision to discontinue its development. We continue to progress our chemically distinct APJ agonists. In parallel, we are advancing our development candidate BGE-102, an oral, brain-penetrant NLRP3 inhibitor with best-in-class potential across multiple metabolic conditions driven by neuroinflammation, including obesity. We have accelerated our clinical timelines for BGE-102, with initial Phase 1 data expected by year’s end. More broadly, our new research collaborations with Novartis and Lilly further validate our platform’s potential to identify novel therapeutic targets. With a robust balance sheet and multiple promising programs advancing toward the clinic, we are well-positioned to execute on our strategy and deliver transformative treatments for metabolic diseases."

 

 

Fourth Quarter 2024 Business Highlights

 

APJ agonists: azelaprag discontinued; Company continues to advance next-gen agonists

In December 2024, BioAge discontinued the STRIDES Phase 2 clinical trial evaluating azelaprag, an orally available small-molecule agonist of APJ, in combination with tirzepatide for the treatment of obesity. The Company’s decision followed observations of unexpected liver transaminitis without clinically significant symptoms in some patients in the azelaprag arms of the STRIDES trial. In previous GLP toxicology studies and Phase 1 studies conducted by Amgen and BioAge, azelaprag was generally well tolerated, without predicted risk of transaminitis or liver injury.

 

The Company is continuing to develop APJ agonists structurally distinct from azelaprag for obesity and related metabolic conditions.

 

NLRP3 inhibitors: progression of BGE-102, with initial clinical data expected 2H25

In January 2025, BioAge nominated BGE-102, a member of its novel, proprietary class of orally available small-molecule NLRP3 inhibitors with distinctive structural and biological properties, as a development candidate. BGE-102 has potential best-in-class features, including high potency and high brain penetration, important attributes for a compound that could be used for treatment of neuroinflammation linked to conditions such as obesity.
Potential for use in an oral combination for obesity: in preclinical models, NLRP3 inhibition has demonstrated weight loss both as a monotherapy and in combination with a GLP-1 receptor agonist
IND-enabling experiments for BGE-102 are currently underway, with Phase 1 single ascending dose (SAD) data anticipated in 2H25 and multiple ascending dose (MAD) data anticipated in 1H26.

 

Platform and broader pipeline: Strategic collaborations with Novartis and Lilly

In December 2024, BioAge established a multi-year collaboration with Novartis to discover novel targets for therapies that address age-related diseases and conditions. The collaboration will leverage insights from BioAge's unique longitudinal human aging datasets and Novartis expertise in the biology of physical exercise to identify drug targets to treat diseases related to aging. This complementary approach aims to translate insights from BioAge's platform into novel therapies that could address fundamental mechanisms of metabolic decline. Novartis will pay up to $20 million comprising upfront payments and research funding; BioAge may receive up to $530 million in future long-term research, development, and commercial milestones [link].
In January 2025, BioAge announced that the Company has entered a strategic collaboration with Lilly ExploR&D (part of Lilly Catalyze360) to discover two therapeutic antibodies that address novel metabolic aging targets identified through BioAge's discovery platform. This collaboration complements BioAge's small molecule expertise and broadens the modalities through which the Company can address targets emerging from its proprietary platform.

 

 

Full Year 2024 Financial Results

 

Research and development expenses were $59.0 million for the year ended December 31, 2024, compared to $33.9 million for the same period in 2023. The $25.1 million increase in research and development expenses was primarily attributable to a $22.8 million increase in costs related to the development of azelaprag driven by the Phase 2 STRIDES trial and costs related to the manufacture of azelaprag.

 


 

General and administrative expenses were $19.2 million for the year ended December 31, 2024, compared to $14.5 million for the same period in 2023. The $4.7 million increase was primarily attributable to an increase in stock-based compensation expense associated with option grants issued in 2024 to employees, executives, board members and advisors.

 

Net loss was $71.1 million for the year ended December 31, 2024, or $6.63 per weighted-average common share outstanding, basic and diluted, compared to a net loss of $63.9 million, or $38.17 per weighted-average common share outstanding, basic and diluted, for the same period in 2023.

 

As of December 31, 2024, BioAge had approximately $354.3 million in cash and cash equivalents. Based on our current operating plan, BioAge estimates that existing cash and cash equivalents 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 related to our anticipated preclinical and clinical development activities, timing of announcements of clinical results for BGE-102, trial initiation, and regulatory filings, potential benefits of the Company’s other product candidates and platform, the potential and timing of future milestone payments under the agreement with Novartis, the success or outcomes associated with the Company’s collaboration with Lilly ExploR&D, the sufficiency of our cash and cash equivalents and current cash runway. 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; risks associated with current and potential future healthcare reforms; risks relating to attracting and retaining key personnel; failure to comply with legal and regulatory requirements; 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 Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 20, 2025, and BioAge’s quarterly reports and 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 Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share information)

 

 

For the Year Ended

 

 

December 31,

 

 

2024

 

 

2023

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

$

59,036

 

 

$

33,886

 

General and administrative

 

 

19,158

 

 

 

14,514

 

Total operating expenses

 

 

78,194

 

 

 

48,400

 

Loss from operations

 

 

(78,194

)

 

 

(48,400

)

Other income (expense), net:

 

 

 

 

 

 

Interest expense

 

 

(2,367

)

 

 

(7,794

)

Interest and other income (expense), net

 

 

9,629

 

 

 

2,431

 

Changes in fair value of warrants and derivative liabilities

 

 

73

 

 

 

(10,091

)

Loss on extinguishment of debt

 

 

(250

)

 

 

 

Total other income (expense), net

 

 

7,085

 

 

 

(15,454

)

Net loss

 

$

(71,109

)

 

$

(63,854

)

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

 

$

(6.63

)

 

$

(38.17

)

Weighted-average common shares outstanding, basic and dilutive

 

 

10,726,521

 

 

 

1,672,793

 

Comprehensive loss:

 

 

 

 

 

 

Net loss

 

 

(71,109

)

 

 

(63,854

)

Foreign currency translation adjustment

 

 

81

 

 

 

(3

)

Total comprehensive loss

 

$

(71,028

)

 

$

(63,857

)

 


 

BIOAGE LABS, INC.

Unaudited Consolidated Balance Sheets

(in thousands, except share and per share information)

 

 

December 31,

 

 

December 31,

 

 

2024

 

 

2023

 

Assets

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

354,349

 

 

$

21,644

 

Restricted cash

 

 

 

 

 

3,313

 

Prepaid expenses and other current assets

 

 

2,754

 

 

 

349

 

Total current assets

 

 

357,103

 

 

 

25,306

 

Investments

 

 

100

 

 

 

100

 

Property and equipment, net

 

 

591

 

 

 

323

 

Operating lease right-of-use assets

 

 

200

 

 

 

195

 

Other Assets

 

 

240

 

 

 

 

Total assets

 

$

358,234

 

 

$

25,924

 

Liabilities

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,996

 

 

$

1,866

 

Accrued expenses and other current liabilities

 

 

11,751

 

 

 

7,938

 

Current portion of term loan

 

 

6,000

 

 

 

6,000

 

Operating lease liabilities, current

 

 

202

 

 

 

194

 

Convertible promissory notes

 

 

 

 

 

20,674

 

Convertible promissory notes embedded derivative liability

 

 

 

 

 

18,183

 

Deferred grant income

 

 

 

 

 

3,313

 

Deferred revenue, current

 

 

7,826

 

 

 

 

Total current liabilities

 

 

27,775

 

 

 

58,168

 

Deferred revenue

 

 

4,674

 

 

 

 

Term loan

 

 

2,502

 

 

 

8,201

 

Warrant liability

 

 

156

 

 

 

229

 

Total liabilities

 

 

35,107

 

 

 

66,598

 

Redeemable convertible preferred stock, par value of $0.00001, no shares issued and outstanding as of December 31, 2024; 31,634,362 shares authorized as of December 31, 2023, and 31,465,128 shares issued and outstanding as of December 31, 2023; aggregate liquidation preference of $131,864 as of December 31, 2023

 

 

 

 

 

132,722

 

Stockholders’ Equity (Deficit)

 

 

 

 

 

 

Preferred stock, $0.00001 par value; 10,000,000 shares authorized as of December 31, 2024; no shares issued and outstanding as of December 31, 2024; no shares authorized, issued, or outstanding as of December 31, 2023

 

 

 

 

 

 

Common stock, $0.00001 par value; 500,000,000 and 52,400,000 shares authorized as of December 31, 2024 and December 31, 2023, respectively; 35,850,037 and 1,673,314 shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively

 

 

 

 

 

 

Additional paid-in-capital

 

 

575,693

 

 

 

8,142

 

Accumulated other comprehensive income

 

 

245

 

 

 

164

 

Accumulated deficit

 

 

(252,811

)

 

 

(181,702

)

Total stockholders’ equity (deficit)

 

 

323,127

 

 

 

(173,396

)

Total liabilities, redeemable convertible preferred stock, and stockholders’ equity (deficit)

 

$

358,234

 

 

$

25,924