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Top-Line Data From MAD Part 2 of the Phase 1 Trial of DA-1726 Expected in April of 2025 Announced Positive Top-Line 16-Week Results from the Phase 2a Trial of DA-1241 for the Treatment of MASH, in December, Demonstrating

Key Takeaway: MetaVia Inc. has announced positive top-line results from the Phase 2a trial of DA-1241, showing reductions in alanine transaminase levels and improvements in hemoglobin A1C. The company anticipates releasing top-line data from the MAD Part 2 of the Phase 1 trial of DA-1726 in April 2025, which targets obesity treatment. With $16 million in cash, MetaVia is well-positioned to continue its clinical development, aiming for an early proof-of-concept study for DA-1726 by late 2025. Both candidates show promise in their respective therapeutic areas focused on cardiometabolic diseases.

Market Sentiment Analysis

POSITIVE FACTORS

  • DA-1726 shows a strong safety profile and potential to become a best-in-class obesity treatment.
  • DA-1241 achieved primary and secondary endpoints with positive effects on liver and glucose levels.
  • Company has sufficient cash to fund operations into 2025, supporting ongoing trials.

Full Press Release Details

Top-Line Data From MAD Part 2 of the Phase 1 Trial of DA-1726 Expected in April of 2025
Announced Positive Top-Line 16-Week Results from the Phase 2a Trial of DA-1241 for the Treatment of MASH, in December, Demonstrating Direct Hepatic Action in Addition to Its Glucose Lowering Effect
$16.0 Million in Cash at End of Fourth Quarter Expected to Fund the Company Into the Third Quarter of 2025
CAMBRIDGE, Mass., March 20, 2025 - MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced financial results for the year ended December 31, 2024 and provided a corporate strategic update.
"Throughout 2024, we made exceptional progress advancing the clinical development of our two, next generation cardiometabolic assets. We eagerly anticipate reporting top-line results from the expanded cohorts of the multiple ascending dose (MAD) Part 2 of our Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity," stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. "In light of the strong safety profile from the planned cohorts of the SAD Part 1 and MAD Part 2 of the study, we are adding additional cohorts to further explore the maximum tolerated dose, which will allow us to realize the full potential of DA-1726. It is important to note that many patients using current GLP-1 agonists discontinue treatment due to tolerability issues, with 20% to 30% stopping within the first two months and up to 70% discontinuing within a year. Based on the preclinical data gathered so far and DA-1726's balanced activation of GLP1R and glucagon receptors, which enhances energy expenditure, we remain confident that DA-1726 has the potential to become a best-in-class obesity drug, offering superior tolerability compared to currently marketed GLP-1 agonists and those in late-stage clinical trials. The top-line data from the MAD Part 2 study, expected shortly, will give us an early read on clinical efficacy. We remain committed to the rapid clinical development of DA-1726 and continue to plan for an early proof-of-concept study to assess the efficacy and safety of DA-1726, which is expected to commence during the fourth quarter of 2025."
Mr. Kim continued, "In December, we reported positive top-line 16-week results from the two-part Phase 2a clinical trial of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, in patients with presumed metabolic dysfunction-associated steatohepatitis (MASH). DA-1241 met the primary endpoint, achieving a reduction in alanine transaminase (ALT) levels through direct hepatic effects, along with key secondary endpoints, including significantly lower hemoglobin A1C (HbA1C) levels compared to placebo. These are very positive results especially given the small study size. Importantly, DA-1241 demonstrated excellent tolerability, with mostly mild adverse events and no drug-related serious adverse events in the treatment groups. Based on these findings, we remain confident that DA-1241's novel mechanism of action, which targets the inflammation associated with MASH, has the potential to result in a safe and effective treatment for this disease. We continue to conduct preclinical studies with a focus on exploring combination therapies for DA-1241, which has the potential to offer further benefits across the full spectrum of MASH. We look forward to reporting the complete data set, which we intend to present at a major medical meeting. Additionally, we anticipate scheduling an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in the first half of 2025."
Fourth Quarter 2024 and Subsequent Highlights
Anticipated Clinical Milestones
Full Year 2024 Financial and Operating Results
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. 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.
Marshall H. Woodworth
Chief Financial Officer
Rx Communications Group
- Tables to Follow -
Consolidated Balance Sheets
(In thousands, except per share amounts)
As of December 31,
2024 2023
Assets
Current assets
Cash $ 16,017 $ 22,435
Prepaid expenses and other current assets 55 77
Total current assets 16,072 22,512
Property and equipment, net 34 46
Right-of-use asset 133 202
Other assets 21 21
Total assets $ 16,260 $ 22,781
Liabilities and stockholders' equity
Current liabilities
Accounts payable $ 3,879 $ 821
Clinical trial accrued liabilities 1,696 3,033
Accrued expenses and other current liabilities 785 592
Warrant liabilities 361 658
Related party payable 1,472 789
Lease liability, short-term 78 67
Total current liabilities 8,271 5,960
Lease liability, long-term 58 136
Total liabilities 8,329 6,096
Commitments and contingencies
Stockholders' equity
Preferred stock, $0.001 par value per share; 10,000 shares authorized and no shares issued or outstanding as of December 31, 2024 and 2023 - -
Common stock, $0.001 par value per share, 100,000 shares authorized as of December 31, 2024 and 2023; 8,637 and 4,906 shares issued and outstanding as of December 31, 2024 and 2023, respectively 9 5
Additional paid-in capital 143,779 124,945
Accumulated deficit (135,857) (108,265)
Total stockholders' equity 7,931 16,685
Total liabilities and stockholders' equity $ 16,260 $ 22,781
Consolidated Statements of Operations
(In thousands, except share and per share amounts)
Year Ended December 31,
2024 2023
Operating expenses
Research and development $ 21,553 $ 9,158
General and administrative 7,256 6,728
Total operating expenses 28,809 15,886
Loss from operations (28,809) (15,886)
Other income
Change in fair value of warrant liabilities 297 2,955
Interest income 920 461
Total other income 1,217 3,416
Loss before income taxes (27,592) (12,470)
Provision for income taxes - -
Net loss and comprehensive net loss (27,592) (12,470)
Loss per share of common stock, basic and diluted $ (3.56) $ (2.46)
Weighted average shares of common stock, basic and diluted 7,757,128 5,071,101

Frequently Asked Questions

What are the expected results for DA-1726?

Top-line data from the MAD Part 2 trial of DA-1726 is anticipated in April 2025.

What is the focus of DA-1241 in clinical trials?

DA-1241 targets metabolic dysfunction-associated steatohepatitis (MASH) and showed positive results.

How much cash did MetaVia have by Q4 2024?

$16.0 million in cash is projected to fund operations until Q3 2025.

What does DA-1726 target in obesity treatment?

DA-1726 is a dual agonist that activates GLP1R and GCGR to help reduce obesity.

What is the primary goal of DA-1241?

DA-1241 aims to reduce alanine transaminase levels in patients with MASH.

Last updated: Mar 20, 2025