8-K - MTVA - Equibles

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 4, 2025

METAVIA INC.

(Exact name of Registrant as Specified in Its Charter)


Delaware		001-37809		47-2389984
(State or other jurisdiction<br><br>of incorporation)		(Commission<br><br>File Number)		(IRS Employer<br><br>Identification No.)

<br><br><br><br>
545 Concord Avenue , Suite 210<br><br>Cambridge , Massachusetts ****<br><br>		02138
(Address of principal executive offices)		(Zip Code)

( 857 ) 702-9600

(Registrant’s telephone number, including area code)

Not applicable

(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:

	<br><br>
Title of each class	Trading<br><br>Symbol(s)		Name of each exchange on which registered
Common Stock, par value 0.001 per share	MTVA		The Nasdaq Stock Market LLC

All values are in US Dollars.

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 Disclosures.

On August 4, 2025, MetaVia Inc. issued a press release announcing a research collaboration with Syntekabio, Inc., a leading artificial intelligence (AI)-driven drug discovery company, to identify additional disease targets and optimize the therapeutic profile of DA-1241, MetaVia’s novel oral G-Protein-Coupled Receptor 119 (GPR119) agonist. A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”).

Information contained on or accessible through any website reference in the press release is not part of, or incorporated by reference in, this Report, and the inclusion of such website addresses in this Report by incorporation by reference of the press release is as inactive textual references only.

The information in this Report, including Exhibit 99.1 attached hereto, is furnished pursuant to Item 7.01 and shall not be deemed "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, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing. The Company’s submission of this Report shall not be deemed an admission as to the materiality of any information required to be disclosed solely to satisfy the requirements of Regulation FD.

Forward-Looking Statements

Exhibit 99.1 attached hereto contain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements are based on current expectations and are not guarantees of future performance. Further the forward-looking statements are subject to the limitations listed in Exhibit 99.1 and in the other reports of the Company filed with the Securities and Exchange Commission, including that actual events or results may differ materially from those in the forward-looking statements.

Item 9.01.Financial Statements and Exhibits.

(d) Exhibits


Exhibit<br>Number		Exhibit Description
99.1		Press Release dated August 4, 2025.
104		Cover Page Interactive Data File (embedded within 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.


	METAVIA INC.


Date: August 4, 2025	By:	/s/ Hyung Heon Kim
		Hyung Heon Kim
		President and Chief Executive Officer

Exhibit 99.1

MetaVia Announces AI-Driven Collaboration with Syntekabio to Explore Additional Indications for DA-1241

Partnership Leverages Syntekabio’s DeepMatcher® Platform to Expand the Therapeutic Potential of MetaVia’s Oral GPR119 Agonist

CAMBRIDGE, Mass., August 4, 2025 – MetaVia Inc. (Nasdaq: MTVA), **** a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced a research collaboration with Syntekabio, Inc., a leading artificial intelligence (AI)-driven drug discovery company, to identify additional disease targets and optimize the therapeutic profile of DA-1241, MetaVia’s novel oral G-Protein-Coupled Receptor 119 (GPR119) agonist.

This collaboration follows positive results from MetaVia’s 16-week, 109-subject Phase 2a study of DA-1241, which demonstrated a favorable safety and tolerability profile alongside both hepatoprotective and glucose-regulating effects in presumed metabolic dysfunction-associated steatohepatitis (MASH) patients.

“The strong safety and tolerability profile shown in our Phase 2a data gives us confidence in DA-1241’s broader therapeutic potential,” stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. “Building on this clinical foundation, we are collaborating with Syntekabio to strategically expand the potential value of DA-1241. Specifically, we will leverage their proprietary DeepMatcher® compound-protein interaction (CPI) AI prediction platform to conduct large-scale virtual screening against more than 1,700 validated protein targets to uncover new, high-potential indications while ensuring specificity and minimizing the risk of off-target effects. This data-driven approach will allow us to accelerate discovery and maximize the value of DA-1241. We believe this unique oral, well-tolerated candidate has the potential to address a range of unmet needs, and we look forward to initial insights from the collaboration later this year.”

About DA-1241

DA-1241 is a novel G-Protein-Coupled Receptor 119 (GPR119) agonist with development optionality as a standalone and/or combination therapy for both MASH and type 2 diabetes (T2D). Agonism of GPR119 in the gut promotes the release of key gut peptides GLP-1, GIP, and PYY. These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. DA-1241 has beneficial effects on glucose, lipid profile and liver inflammation, supported by potential efficacy demonstrated during in vivo preclinical studies. The therapeutic potential of DA-1241 has been demonstrated in multiple pre-clinical animal models of MASH and T2D where DA-1241 reduced hepatic steatosis, inflammation, fibrosis, and improved glucose control. Furthermore, in Phase 1a, 1b and 2a trials, DA-1241 was well tolerated in both healthy volunteers and those with T2DM. In a Phase 2a clinical study, DA-1241 demonstrated direct hepatic action in addition to its glucose lowering effects.

About Syntekabio

Syntekabio Co., Ltd. (KOSDAQ: 226330) is a drug discovery company bringing together biology and AI/ML since 2009 and facilitating the discovery of first-in-class and best-in-class compounds, rapidly. The company has its own supercomputer cloud, along with a global contract research organization network to complement and validate its computational results. Syntekabio offers clients a one-stop shop, with technologies and tailored services to rapidly generate and optimize drug candidates from target to IND-

enabling. Syntekabio’s disease-agnostic platform generates a continual stream of hits, leads, and drug candidates that are readily available for purchase. The company also undertakes client-specific projects to identify highly promising development candidates for specific targets and indications.

About MetaVia

MetaVia Inc. is a clinical-stage biotechnology company focused on transforming cardiometabolic diseases. The company is currently developing DA-1726 for the treatment of obesity and is developing DA-1241 for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH). DA-1726 is a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist. OXM is a naturally-occurring gut hormone that activates GLP1R and GCGR, thereby decreasing food intake while increasing energy expenditure, thus potentially resulting in superior body weight loss compared to selective GLP1R agonists. In a Phase 1 multiple ascending dose (MAD) trial in obesity, DA-1726 demonstrated best-in-class potential for weight loss, glucose control, and waist reduction. DA-1241 is a novel G-protein-coupled receptor 119 (GPR119) agonist that promotes the release of key gut peptides GLP-1, GIP, and PYY. In pre-clinical studies, DA-1241 demonstrated a positive effect on liver inflammation, lipid metabolism, weight loss, and glucose metabolism, reducing hepatic steatosis, hepatic inflammation, and liver fibrosis, while also improving glucose control. In a Phase 2a clinical study, DA-1241 demonstrated direct hepatic action in addition to its glucose lowering effects.

For more information, please visit www.metaviatx.com.

Forward Looking Statements

Certain statements in this press release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", “potential”, "intends", "projects", "plans", "estimates" or the negative of these words or other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including, without limitation, those risks associated with MetaVia's ability to execute on its commercial strategy; our expectations regarding the sufficiency of our existing cash on hand to fund our operations; the timeline for regulatory submissions; the ability to obtain regulatory approval through the development steps of MetaVia's current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co. Ltd., including the impact on future financial and operating results of MetaVia; the cooperation of MetaVia's contract manufacturers, clinical study partners and others involved in the development of MetaVia's current and future product candidates; potential negative interactions between MetaVia's product candidates and any other products with which they are combined for treatment; MetaVia's ability to initiate and complete clinical trials on a timely basis; MetaVia's ability to recruit subjects for its clinical trials; whether MetaVia receives results from MetaVia's clinical trials that are consistent with the results of pre-clinical and previous clinical trials; impact of costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the effects of changes in applicable laws or regulations; the effects of changes to MetaVia's stock price on the terms of the license agreement and any future fundraising; and other risks and uncertainties described in MetaVia's filings with the Securities and Exchange Commission, including MetaVia's most recent Annual Report on Form 10-K. Forward-looking statements speak only as of the date when made. MetaVia does

not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts:

MetaVia

Marshall H. Woodworth

Chief Financial Officer

+1-857-299-1033

marshall.woodworth@metaviatx.com

Rx Communications Group

Michael Miller

+1-917-633-6086

mmiller@rxir.com