Positive interim Phase 1 data for BGE-102, a potent, structurally novel, orally available, brain-penetrant small-molecule NLRP3 inhibitor, demonstrating potential best-in-class reductions in inflammatory biomarkers of cardiovascular risk; Phase 2a proof-of-concept trial planned to initiate in 1H 2026
Indication expansion for BGE-102 into ophthalmology; Phase 1b/2a proof-of-concept trial in diabetic macular edema planned to initiate mid-2026
Completed upsized follow-on public offering of $132.3 million with full exercise of the underwriters' overallotment option in February 2026
EMERYVILLE, Calif., March 24, 2026 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. ("BioAge", "the Company"), a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today provided financial results for the full year ended December 31, 2025 and business updates for the fourth quarter ended December 31, 2025.
"The past few months have been a defining period for BioAge as we delivered positive interim Phase 1 data for BGE-102 demonstrating potential best-in-class reductions in inflammatory biomarkers of cardiovascular risk, including hsCRP, IL-6, and fibrinogen," said Kristen Fortney, PhD, CEO and co-founder of BioAge. "These results support BGE-102's potential to deliver injectable-like anti-inflammatory efficacy in a convenient oral therapy, and we are advancing toward a Phase 2a proof-of-concept study in the first half of this year. We also expanded BGE-102 into ophthalmology, where its unique profile positions it as a potential 'pipeline in a pill' across cardiovascular, CNS, and ocular diseases. In parallel, we are actively advancing a follow-on NLRP3 inhibitor program to create optionality to address the many diseases driven by the inflammasome. With our upsized $132.3 million follow-on offering, we have further strengthened our balance sheet to support our expanding clinical programs."
Business Highlights
NLRP3 inhibitor clinical development
-- In December 2025, BioAge announced positive interim data from the ongoing
Phase 1 single ascending dose (SAD) / multiple ascending dose (MAD) trial
of BGE-102, its oral, brain-penetrant NLRP3 inhibitor. BGE-102 was well
tolerated across all doses, with dose-proportional pharmacokinetics
supporting once-daily dosing, 90--98% suppression of IL-1<BETA> in an ex
vivo whole blood assay at Day 14, and cerebrospinal fluid concentrations
exceeding the IC90 at doses of 60 mg and above -- a key differentiator
from other NLRP3 inhibitors in development. The Company expanded the
trial to include MAD cohorts in participants with obesity and elevated
hsCRP.
-- In January 2026, BioAge announced additional positive interim Phase 1
data from the first MAD cohort in participants with obesity and elevated
hsCRP. At Day 14, BGE-102 120 mg once daily achieved an 86% median
reduction in hsCRP, with 93% of participants reaching levels below 2 mg/L,
a threshold for reduced cardiovascular risk.
-- BGE-102 also achieved a 58% reduction in IL-6 and a 30% reduction in
fibrinogen.
-- Full Phase 1 data are anticipated in the first half of 2026.
-- The Company plans to initiate a Phase 2a proof-of-concept trial in
cardiovascular risk in the first half of 2026. The trial has been
expanded to incorporate dose-ranging, with the goal of potentially
enabling initiation of a Phase 3 registration study by the end of 2027.
Phase 2a data are expected in the second half of 2026.
BGE-102 indication expansion into ophthalmology
-- BioAge announced the expansion of its BGE-102 development program into
ophthalmology, with an initial proof-of-concept study planned in patients
with diabetic macular edema (DME). NLRP3 inflammasome activation is a
central pathological feature in a range of retinal diseases. In
preclinical models, oral BGE-102 demonstrated dose-dependent preservation
of retinal vascular integrity, achieving near-complete protection from
vascular leakage.
-- The Company plans to initiate a Phase 1b/2a proof-of-concept trial in
patients with DME in mid-2026, with results anticipated in mid-2027. The
DME trial will run in parallel with the BGE-102 Phase 2a cardiovascular
risk trial.
APJ agonist program advancement
-- The Company continued to advance its oral and parenteral APJ agonist
development strategy. Under the exclusive option agreement with JiKang
Therapeutics announced in June 2025, BioAge and JiKang are jointly
advancing a novel APJ agonist nanobody demonstrating at least 10-fold
greater potency than apelin toward Investigational New Drug
$(IND)$-enabling studies.
-- In parallel, BioAge is progressing its proprietary portfolio of orally
active APJ agonists for which it filed a U.S. provisional patent
application in May 2025.
-- BioAge intends to file the first IND for an APJ program by 2026 year end.
Upsized follow-on public offering
-- In January 2026, BioAge completed an upsized follow-on public offering of
5,897,435 shares of common stock at a public offering price of $19.50 per
share, generating gross proceeds of approximately $115.0 million. In
February 2026, the underwriters exercised their overallotment option in
full, purchasing an additional 884,615 shares of common stock at the
public offering price, resulting in total gross proceeds from the
offering of approximately $132.3 million. The offering was led by Goldman
Sachs, Piper Sandler, and Citigroup. The Company estimates that the
proceeds from this financing, together with our $285.1 million in cash,
cash equivalents, and marketable securities as of December 31, 2025, will
be sufficient to fund operations through 2029 based on its current
operating plan.
Strategic partnerships and discovery platform
-- BioAge's multi-year research collaboration with Novartis, focused on
discovering novel therapeutic targets at the intersection of aging
biology and exercise physiology, continued to advance, with multiple
targets under evaluation.
-- The Company progressed its strategic collaboration with Lilly ExploR&D
for the development of therapeutic antibodies targeting novel metabolic
aging targets identified through BioAge's discovery platform.
-- BioAge continued to advance its initiative to comprehensively profile and
analyze samples from the HUNT Biobank in Norway through its collaboration
with Age Labs AS, generating molecular insights from more than 17,000
individual samples tracking the transition from health to disease over
decades of lifespan.
Full Year 2025 Financial Results
Collaboration revenue was $9.0 million for the year ended December 31, 2025, compared to no revenue for the same period in 2024. The $9.0 million increase in collaboration revenue was the result of revenue recognized under our multi-year research collaboration with Novartis, as work commenced in 2025.
Research and development expenses were approximately $73.9 million for the year ended December 31, 2025, compared to $59.0 million for the same period in 2024. The $14.9 million increase in research and development expenses was primarily attributable to a $24.3 million increase in direct costs for other programs, primarily related to work performed under the Novartis Agreement and licensing, discovery and development activities related to our novel apelin receptor APJ agonist programs, and a $14.4 million increase in direct costs related to our BGE-102 program associated with IND-enabling activities, drug-product manufacturing and our ongoing Phase 1 SAD/MAD clinical trial. Further contributing to the increase in research and development expenses was a $1.2 million increase in personnel-related expenses, driven by stock-based compensation grants to employees, and a $1.4 million increase in allocated facility and other expenses primarily related to facility expenses for our new headquarters. These increases were partially offset by a $26.4 million reduction in azelaprag direct costs following termination of development in January 2025.
General and administrative expenses were $27.8 million for the year ended December 31, 2025, compared to $19.2 million for the same period in 2024. The $8.6 million increase was primarily attributable to a $3.9 million increase in personnel-related expenses, largely due to an increase in stock-based compensation expense associated with new option grants issued to employees, executives, board members and advisors, a $2.9 million increase in legal fees, a $1.2 million increase in franchise taxes and insurance, primarily related to our public company director and officer insurance policy, and a $0.6 million increase in information technology and equipment costs, primarily related to software expense.
Net loss was $80.6 million for the year ended December 31, 2025, or $2.24 per weighted-average common share outstanding, basic and diluted, compared to a net loss of $71.1 million, or $6.63 per weighted-average common share outstanding, basic and diluted, for the same period in 2024.
As of December 31, 2025, BioAge had approximately $285.1 million in cash, cash equivalents, and marketable securities. 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 lead product candidate, BGE-102, is a potent, orally available, brain-penetrant small-molecule NLRP3 inhibitor being developed for cardiovascular risk and retinal diseases. A Phase 1 SAD/MAD trial of BGE-102 is underway, with topline data including additional MAD cohorts anticipated in 1H26. 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. In some cases, you can identify forward-looking statements by terms such as "aim," "may," "will, " "should," "expect," "forecast," "plan," "anticipate," "could," "intend, " "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. All statements other than statements of historical fact contained in this press release, including without limitation statements regarding our plans to develop and commercialize our product candidates, including BGE-102 and our APJ programs, the potential for BGE-102 as a treatment for atherosclerotic cardiovascular disease risk reduction and diabetic macular edema and the expected timeline for data readouts from our ongoing Phase 1 clinical trial, the timing and results of our ongoing or planned preclinical studies and clinical trials, risks associated with clinical trials, including our ability to adequately manage clinical activities for BGE-102 and our APJ programs, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, the timing of and our ability to obtain and maintain regulatory approvals, the clinical utility of our future product candidates, our commercialization, marketing and manufacturing capabilities and strategy, our expectations about the willingness of healthcare professionals to use our product candidates, the sufficiency of our cash, cash equivalents and marketable securities, general economic conditions, the impact of industry and market conditions on our operations, including fluctuating interest rates and inflation, increased volatility in the debt and equity markets, legislative or regulatory healthcare reforms in the United States, significant political, trade or regulatory developments, including tariffs, federal government shutdowns, or shifting priorities within the U.S. Food and Drug Administration, cybersecurity incidents, and global regional conflicts, and the plans and objectives of management for future operations and capital expenditures are forward-looking statements.
The forward-looking statements in this press release are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including those described under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" included in BioAge's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 24, 2026, and BioAge's other filings with the SEC filed from time to time.
Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. 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,
2025 2024
----------- -----------
Collaboration Revenue $ 8,995 $ --
Operating expenses:
Research and development 73,966 59,036
General and administrative 27,809 19,158
Total operating expenses 101,775 78,194
---------- ----------
Loss from operations (92,780) (78,194)
Other income (expense), net:
Interest expense (697) (2,367)
Interest and other income
(expense), net 13,086 9,629
Gain (loss) from changes in fair
value of warrants (214) 73
Loss on extinguishment of debt -- (250)
Total other income (expense),
net 12,175 7,085
---------- ----------
Net loss $ (80,605) $ (71,109)
========== ==========
Net loss per share attributable to
common stockholders, basic and
diluted (2.24) $ (6.63)
========== ==========
Weighted-average common shares
outstanding, basic and dilutive 35,932,914 10,726,521
---------- ----------
Comprehensive loss:
Net loss (80,605) (71,109)
Unrealized holding gains on
available-for-sale investments 122 --
Foreign currency translation
adjustment (89) 81
Total other comprehensive income 33 81
---------- ----------
Total comprehensive loss $ (80,572) $ (71,028)
========== ==========
BIOAGE LABS, INC.
Unaudited Consolidated Balance Sheets
(in thousands, except share and per share information)
December 31, December 31,
2025 2024
Assets
Current Assets:
Cash and cash equivalents $ 188,888 $ 354,349
Marketable securities, current 92,210 --
Accounts receivable 769 --
Prepaid expenses and other
current assets 4,926 2,754
Total current assets 286,793 357,103
---------- ----------
Investments 100 100
Marketable securities 4,032 --
Property and equipment, net 963 591
Operating lease right-of-use assets 2,785 200
Other assets 216 240
Total assets $ 294,889 $ 358,234
========== ==========
Liabilities
Current Liabilities:
Accounts payable $ 2,674 $ 1,996
Accrued expenses and other
current liabilities 8,480 11,751
Current portion of term loan 2,648 6,000
Operating lease liabilities,
current 582 202
Deferred revenue, current 5,754 7,826
Total current liabilities 20,138 27,775
---------- ----------
Deferred revenue -- 4,674
Term loan -- 2,502
Warrant liability 370 156
Operating lease liabilities 2,330 --
Total liabilities 22,838 35,107
========== ==========
Commitments and Contingencies
(Note 8)
Stockholders' Equity
Preferred stock, $0.00001 par
value; 10,000,000 shares authorized
as of December 31, 2025 and
December 31, 2024; no shares issued
and outstanding as of December 31,
2025 and December 31, 2024 -- --
Common stock, $0.00001 par value;
500,000,000 shares authorized as of
December 31, 2025 and December 31,
2024; 37,386,908 and 35,850,037
shares issued and outstanding as of
December 31, 2025 and December 31,
2024, respectively -- --
Additional paid-in-capital 605,189 575,693
Accumulated other comprehensive
income 278 245
Accumulated deficit (333,416) (252,811)
Total stockholders' equity 272,051 323,127
---------- ----------
Total liabilities and stockholders'
equity $ 294,889 $ 358,234
========== ==========
(END) Dow Jones Newswires
March 24, 2026 09:00 ET (13:00 GMT)
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