Data Expected in April 2025 from Part 2 of Phase 1 Trial of DA-1726
MetaVia Inc. (NASDAQ:MTVA) is currently conducting a Phase 1 clinical trial of DA-1726 in patients with obesity. In September 2024, MetaVia announced positive topline results for the single ascending dose (SAD) Part 1 of the trial. A total of 45 obese but otherwise healthy individuals were randomized in a double blind, 6:3 ratio to receive DA-1726 or placebo. The results showed that DA-1726 was safe, well tolerated, and had linear pharmacokinetics (PK). In regards to safety, only five subjects in the DA-1726 group reported adverse events (AEs) compared to three subjects in the placebo group. Due to the strong safety profile, at least one additional dosing cohort is being added to evaluate the maximum tolerated dose.
The multiple ascending dose (MAD) Part 2 of the trial is ongoing, with the first patient enrolled in June 2024. A total of 36 individuals are expected to be enrolled in Part 2 of the trial in a 6:3 ratio across four dosing cohorts. Each participant will receive four weekly administrations of DA-1726 or placebo. We anticipate topline results from Part 2 of the study in April 2025.
The company continues planning for Part 3 of the trial, which we anticipate initiating in the fourth quarter of 2025, with an interim data readout in mid-2026 and topline results being reported in the second half of 2026. The following slide provides an overview of Part 3 of the trial, which will evaluate early proof of concept and maximum titratable dose of DA-1726.
M&A Activity Continues in Obesity Space
While the biotech sector as a whole has been experiencing a relative downturn, there continues to be robust partnering activities for obesity therapies, as exemplified by the following deals announced in just the past month:
On March 3, 2025, AbbVie (ABBV) announced a licensing deal with Gubra A/S to develop GUB014295, a long-acting amylin analog for the treatment of obesity. Under terms of the deal, Gubra will receive a $350 million upfront cash payment and be eligible for up to $1.875 billion in development, commercial, and sales milestone payments with tiered royalties on global net sales. This marks AbbVie’s entrance into the obesity field.
On March 12, 2025, Roche announced a collaboration and licensing agreement with Zealand Pharma under which the companies will co-develop and co-commercialize petrelinitide, a long-acting amylin analog, as a standalone therapy and as a fixed-dose combination with Roche’s lead asset CT-388. Under terms of the agreement, Zealand Pharma will receive upfront cash payments of $1.65 billion ($1.4 billion at close and $250 million over the first two anniversaries of the collaboration), be eligible for development milestones of $1.2 billion, and sales-based milestones of $2.4 billion. Profits and losses from the sale of petrelintide and petrelintide/CT-388 will be shared 50/50 in the U.S. and Europe and Zealand Pharma is eligible to receive tiered double-digit royalties up to the high teens on net sales in the rest of the world.
On March 24, 2025, Novo Nordisk announced an exclusive licensing agreement with The United Bio-Technology Co., Ltd. for UTB251, a triple agonist of the receptors for GLP-1, glucose-dependent insulinotropic polypeptide (GIP), and glucagon, which is early-stage development for the treatment of obesity, type 2 diabetes, and other diseases. Under terms of the agreement, United Biotechnology will receive an upfront payment of $200 million and be eligible for potential milestone payments of up to $1.8 billion along with tiered royalties on net sales outside of China, Hong Kong, Macau, and Taiwan.
We view these deals as evidence that Big Pharma companies continue to be actively looking for differentiated obesity treatments and those companies are willing to pay substantial amounts to enter into development partnerships for those assets.
Financial Update
On March 20, 2025, MetaVia announced financial results for fiscal year 2024. As expected, the company did not report any revenues in the year ending December 31, 2024. R&D expenses in 2024 were approximately $21.6 million compared to approximately $9.2 million in 2023. The increase was primarily attributed to increased drug manufacturing costs, non-clinical and pre-clinical services, clinical trials, and employee compensation. G&A expenses in 2024 were approximately $7.3 million compared to approximately $6.7 million in 2023. The increase was primarily attributable to higher employee compensation and benefits partially offset by lower consulting expenditures and legal fees.
As of December 31, 2024, MetaVia had approximately $16.0 million in cash and cash equivalents. We estimate that this is sufficient to fund operations into the third quarter of 2025. As of March 17, 2025, MetaVia had approximately 8.7 million shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of approximately 23.1 million.
Conclusion
We are looking forward to the results from Part 2 of the Phase 1 trial, which we anticipate in April 2025. While the results will be primarily focused on safety and tolerability, given the four weeks of dosing the results could offer an early read on clinical efficacy. Looking ahead, Part 3 of the Phase 1 trial will initiate in the fourth quarter of 2025, with an interim read-out planned for mid-2026 and topline results expected by the end of 2026. Following the release of positive Phase 2a results for DA-1241 in MASH in December 2024, the company is planning to conduct an ‘end-of-Phase 2’ meeting with the FDA in the first half of 2025 and the full data set from the Phase 2a study will be presented at a major medical meeting later this year. As we await the results from Part 2 of the Phase 1 trial of DA-1726 our valuation remains at $23.00 per share.
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