8-K
MetaVia Inc. (MTVA)
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): April 22, 2025
METAVIA INC.
(Exact name of Registrant as Specified in Its Charter)
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| 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:
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| ☐ | 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:
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|---|---|---|---|
| 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 Disclosure.
On April 22, 2025, MetaVia Inc. (the “Company”) issued a press release reporting additional top-line results from the multiple ascending dose Part 2 of its Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin analog agonist that functions as a glucagon-like peptide-1 receptor and glucagon receptor, further demonstrating its potential as a best-in-class obesity drug. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the “Report”) and incorporated herein by reference.
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.
Item 8.01.Other Events.
On April 22, 2025, the Company posted an updated corporate presentation to its website at https://ir.metaviatx.com/events-presentations/presentations, which the Company may use from time to time in connection with presentations, investor communications or conferences. A copy of the corporate presentation is attached as Exhibit 99.2 to this Report and is incorporated herein by reference.
Forward-Looking Statements
Exhibit 99.1 and Exhibit 99.2 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 Exhibit 99.2, respectively, 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
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|---|---|---|
| Exhibit<br>Number | Exhibit Description | |
| 99.1 | | Press Release dated April 22, 2025. |
| 99.2 | | Corporate Presentation dated April 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.
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| | METAVIA INC. | ||
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| Date: April 22, 2025 | | By: | /s/ Hyung Heon Kim |
| | | | Hyung Heon Kim |
| | | | President and Chief Executive Officer |
Exhibit 99.1
MetaVia Reports Additional Positive Top-Line Results From the MAD Part 2 of Its Phase 1 Study of DA-1726 , a Novel 3:1 Ratio GLP-1 and Glucagon Dual Receptor Agonist to Treat Obesity , Further Demonstrating Its Best-In-Class Potential
A Dose-Dependent Response in Body Weight Reduction Was Observed Between 8 mg and 32 mg Doses
Change in BMI and Body Weight Adjusted for Height In the Treatment Groups, Showed a Significant Difference Compared to Placebo, Indicating Potentially Greater Efficacy with Increasing Dosage and Longer Duration of Use
No Drug-Induced Cardiovascular Effects Were Observed In Heart Rate or QTcF Measurements of Subjects Receiving up to 32 mg of DA-1726 at 4-Weeks
Additional Cohorts Being Added to Determine Maximum Tolerated Dose
CAMBRIDGE, Mass., April 22, 2025 – MetaVia Inc. (Nasdaq: MTVA), **** a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today reported additional top-line results from the multiple ascending dose (MAD) Part 2 of its 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), further demonstrating its potential as a best-in-class obesity drug.
In the 28-day, 36-subject MAD portion of the study, a clear dose-responsive trend in body weight (BW) reduction was observed across the 8 mg to 32 mg range, indicating potentially greater efficacy at higher doses and longer duration of use. Additionally, body mass index (BMI), which shows body weight adjusted for height, showed a difference between the treatment group and the placebo (PBO) group, which was even more pronounced, further supporting the dose-dependent effect of the drug on weight-related outcomes. Of note, DA-1726 did not show any clinically significant increases in heart rate (HR) or QTcF changes up to 32 mg at 4 weeks of administration.
As previously reported, with no titration, DA-1726, with its novel 3:1 ratio between GLP-1R and GCGR at the 32 mg dose, demonstrated compelling maximum weight loss of -6.3% and mean weight loss of -4.3% at Day 26 (p=0.0005), while showing a strong signal of GLP-1R efficacy with maximum lowering of fasted glucose of -18 mg/dL and mean lowering of -5.3 mg/dL at Day 26, and maximum waist circumference reduction of 3.9 inches and mean reduction of 1.6 inches, indicating a strong signal of glucagon efficacy at Day 33.
“This new, additional Phase 1 MAD data further highlights DA-1726’s potential to be a best-in-class obesity treatment, showing impressive weight loss results, particularly in terms of BMI reduction,” stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia. “Specifically, there was a clear dose-dependent effect on body weight loss between 8 mg and 32 mg, with higher doses leading to greater weight reduction. BMI change from baseline showed the difference between the drug group and the placebo group was even more noticeable. Based on the robust safety and tolerability profile of DA-1726, we believe that 32 mg will likely be the starting dose for future clinical trials.”
Mr. Kim continued, “Additionally, activation of either the GLP-1 or glucagon receptors is known to increase heart rate. As a result, dual agonists that simultaneously activate both receptors may raise concerns about excessive heart rate elevation and potential QT interval prolongation. For example, at least one similar dual agonist in clinical trials was discontinued due to an increase in heart rate and other safety concerns. In contrast, the mean heart rate of subjects on DA-1726 showed a slight decrease from baseline in all treatment groups other than the 16 mg cohort where the baseline was significantly lower than other cohorts; the mean decrease after 4 weeks was -14 to -0.7 beats per min (bpm) in the DA-1726 cohorts (4, 8 or 32 mg once weekly) while there was an increase of 7.7 bpm for DA-1726 16 mg cohort. There were no onsets reported in the QTcF (QT interval corrected for heart rate using the method of Fridericia) interval categories >480–500 msec or >500 msec and no risk of cardiovascular events was identified.”
Management also noted that DA-1726's 3:1 balanced activation of GLP-1 and glucagon receptors offers a promising alternative to current GLP-1 agonists, addressing the significant tolerability challenges that lead to 20–30% discontinuation within the first month and up to 70% within a year. As previously reported, a Phase 1 Part 3 study is planned to evaluate DA-1726 patients who discontinued Wegovy® early, aiming to demonstrate improved tolerability, safety, and weight loss outcomes. Additionally, higher-dose cohorts will be included to assess the maximum tolerated dose and fully realize DA-1726's potential as higher doses may also show a similar profile, while potentially demonstrating increased weight reduction.
The Phase 1 trial was a randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. The MAD portion of the study enrolled healthy adults with a minimum body mass index between BMI 30 – 45 kg/m^2^. The primary endpoint of the Phase 1 trial was to assess the safety and tolerability of DA-1726 by monitoring adverse events (AEs), serious adverse events (SAEs), treatment emergent adverse events (TEAEs) and AEs leading to treatment discontinuation. Secondary endpoints included the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726. Exploratory endpoints included the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference and body mass index (BMI), among others.
As previously disclosed, in the 28-day, 36-subject MAD portion of the study, DA-1726 demonstrated excellent safety and tolerability, with positive clinical activity. Four out of six subjects on the 32 mg dose experienced mild gastrointestinal (GI) AEs after the first 32 mg dose, most of which were resolved after 24 hours of occurrence. There were no treatment-related discontinuations or SAEs. Early satiety was observed in 83% of subjects receiving the 32 mg dose, suggesting the potential for greater weight loss with longer treatment duration.
Mr. Kim concluded, “After our initial top-line data was announced pre-market on April 15, 2025, the Company’s previously issued and outstanding pre-funded warrants were exercised for 1,430,000 shares of the Company’s common stock -- leaving no pre-funded warrants outstanding. We continue to believe that the body of data for DA-1726 provides a compelling case for its future potential as a treatment for obesity.”
For more information on this clinical trial, please visit: www.clinicaltrials.gov NCT06252220.
About DA-1726
DA-1726 is a novel oxyntomodulin (OXM) analogue functioning as a GLP1R/GCGR dual agonist for the treatment of obesity and Metabolic Dysfunction-Associated Steatohepatitis (MASH) that is to be administered once weekly subcutaneously. DA-1726 acts as a dual agonist of GLP-1 receptors (GLP1R) and glucagon receptors (GCGR), leading to weight loss through reduced appetite and increased energy
expenditure. DA-1726 has a well understood mechanism and, in pre-clinical mice models, resulted in improved weight loss compared to semaglutide (Wegovy®) and cotadutide (another OXM analogue). Additionally, in pre-clinical mouse models, DA-1726 elicited similar weight reduction, while consuming more food, compared tirzepatide (Zepbound®) and survodutide (a drug with the same MOA), while also preserving lean body mass and demonstrating improved lipid-lowering effects compared to survodutide.
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. 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
Exhibit 99.2
| December 2023<br>NASDAQ: NRBO 1<br>April 2025<br>MetaVia Inc.<br>NASDAQ: MTVA | |||
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| 2<br>Forward-Looking Statements<br>This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or<br>current facts and can be identified by the use of words such as “believes”, “expects”, “anticipates”, “may”, “will”, “should”, “seeks”, “approximately”, “intends”, “projects”, “plans”, “estimates” or the negative of these words or<br>other comparable terminology (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are predictions, projections and other statements about future events<br>that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. These forward-looking statements include, but are not limited to, statements regarding the market size and<br>potential growth opportunities of our current product candidates; the safety, efficacy, tolerability and other potential benefits, such as weight loss, associated with our current product candidates; the competitive differentiators<br>of our current product candidates; potential collaborations and/or licensing partners for our current product candidates; our planned clinical trial activities for our current product candidates; the expected timeline for topline<br>data release dates; and our planned submissions of investigational new drug applications and meetings with the U.S. Food and Drug Administration. Many factors could cause actual future events to differ materially from the<br>forward-looking statements in this presentation, including, without limitation, those risks associated with our ability to execute our commercial strategy; the sufficiency of our existing cash on hand to fund our operations; the<br>timeline for regulatory submissions, regulatory steps and potential regulatory approval of our current and future product candidates; the ability to realize the benefits of the license agreement with Dong-A ST Co., Ltd., including<br>the impact on our future financial and operating results; the ability to integrate our current and future product candidates into our business in a timely and cost-efficient manner; the cooperation of our contract manufacturers,<br>clinical study partners and others involved in the development of our current and future product candidates; our ability to initiate clinical trials on a timely basis; our planned clinical trials and our ability to recruit subjects for our<br>clinical trials; the costs related to the license agreement, known and unknown, including costs of any litigation or regulatory actions relating to the license agreement; the changes in applicable laws or regulations; and the effects<br>of changes to our stock price on the terms of the license agreement and any future fundraising. These forward-looking statements are based on information currently available to us and our current plans or expectations and are<br>subject to a number of known and unknown uncertainties, risks and other important factors that may cause our actual results, performance or achievements expressed or implied by the forward-looking statements. These and<br>other important factors are described in detail in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2024, and our other filings with the Securities and Exchange Commission.<br>While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we<br>believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. These forward-looking statements should not be relied upon as<br>representing our views as of any date subsequent to this presentation.<br>This presentation also may contain estimates and other statistical data made by independent parties and by us relating to market size and other data about our industry. This data involves a number of assumptions and<br>limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are<br>necessarily subject to a high degree of uncertainty and risk. | |||
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| 3<br>Risk Factors<br>Investing in our securities includes a high degree of risk. You should consider carefully the risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2024, including specific factors discussed<br>below, together with all of the other information contained in our SEC filings. If any of the following risks actually occurs, our business, financial condition, results of operations and future prospects would likely be materially and<br>adversely affected. This could cause the market price of our securities to decline and could cause you to lose all or part of your investment. Risks include but are not limited to:<br>▪ We have incurred net losses since inception, and we anticipate that we will continue to incur net losses for the foreseeable future. We require additional capital to accomplish our business plan and the failure to obtain<br>necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our operations.<br>▪ As we do no generate any revenue, we are dependent on working capital to fund our business plan, and raising additional capital may cause dilution to existing stockholders, restrict our operations or require us to<br>relinquish rights to our technologies.<br>▪ Future sales, or the perception of future sales, by us or our securityholders could cause the market price of our common stock to decline.<br>▪ Adverse global economic conditions could have a material adverse effect on our business, results of operations and financial condition and liquidity.<br>▪ We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood<br>of success.<br>▪ Public opinion and scrutiny of treatments for obesity and overweight patients may impact public perception of our Company and DA-1726, or may adversely affect our ability to conduct our business and our business<br>plans.<br>▪ We may be required to make significant payments under the 2022 License Agreement.<br>▪ Even if we obtain favorable clinical results, we may not be able to obtain regulatory approval for, or successfully commercialize DA-1241 and DA-1726.<br>▪ Preliminary, interim and topline data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that<br>could result in material changes in the final data. | |||
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| 4<br>A Clinical Stage Biotech Focused on Cardiometabolic Diseases<br>Targeting Obesity and MASH with a Pipeline of Next Generation Therapeutics<br>A novel GLP1R/GCGR Dual Agonist with GLP-1R:GCGR = 3:1<br>Safety and Tolerability No treatment-related discontinuations with mild<br>GI related events<br>Weight Loss (26th day) Max: -6.3% (15.4 lbs) | Mean -4.3%<br>Fasted Glucose (26th day) Max: -18 mg/dL | Mean: -5.3 mg/dL<br>Waist Circumference (33rd day) Max: -10 cm (3.9in) | Mean: -4 cm (1.6in)<br>No titration or max dose yet established<br>DA-1726 – Obesity (Phase 1 Part 2 at 32 mg Dose)<br>DA-1241 – MASH (Phase 2a Top-Line Data)<br>G Protein-Coupled Receptor<br>Safety and Tolerability Safe and Well-tolerated<br>Phase 2a Primary End Point Met and showed direct hepatic effects<br>HbA1C Significant reductions compared to placebo<br>Other exploratory end points to be released<br>Will be actively seeking for<br>combination/licensing partner<br>Strong weight loss<br>With potential best-in-class<br>glucose control and safety profile<br>FDA requires at least one comorbidity with<br>obesity; DA-1726 showed best-in-class potential<br>Obesity with T2D / MASH |
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| 5<br>Multiple Near-Term Milestones:<br>Targeting to Increase Shareholder Value<br>2026<br>DA-1241 H1 2025<br>Meeting with FDA<br> April 2025<br>Phase 1<br>MAD Top Line Results<br>DA-1726<br>Q3 2025<br>Phase 1 Part 3<br>First Patient In<br>Q2 2025<br>Phase 1 Part 3<br>IND Amend Submission<br>H1 2026<br>Phase 1 Part 3<br>Interim Data<br>Readout<br>* These milestones assume regulatory and clinical success, which is not guaranteed<br>Q2/Q3 2025<br>Phase 1<br>Additional SAD/MAD<br>Q4 2025<br>Phase 1<br>Additional SAD/MAD data<br>To explore maximum tolerated dose<br>32 mg dose, no titration, with Wegovy® early drop-out patients to explore potential superior<br>tolerability/safety and weight loss<br>2025 | |||
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| December 2023<br>NASDAQ: NRBO<br>6<br>DA<br>-1726<br>A Novel GLP1R/GCGR<br>Dual Agonist for the<br>Treatment of Obesity | |||
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| 7<br>DA-1726: Mechanism of Action<br>DA-1726 is a novel oxyntomodulin analogue functioning as a GLP1R/GCGR dual agonist for the<br>treatment of obesity<br>Notes: GLP1R/GCGR (Glucagon-Like Peptide 1 Receptor/Glucagon Receptor);<br>GLP-1 (Glucagon-Like Peptide 1)<br>1. Pocai A. Mol Metab.2014;3:241-51<br>▪ Oxyntomodulin<br>• a gut hormone released from intestinal<br>L-cells after meal ingestion resulting in dual<br>agonism of the GLP-1 receptor and glucagon<br>receptor<br>▪ Reduces food intake (GLP-1 R) and increases<br>energy expenditure (GCGR) in humans,<br>potentially resulting in superior body weight loss<br>Physiological effects of oxyntomodulin(1) | |||
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| 8<br>A Single Site, Randomized, Double-Blind, Placebo-Controlled, Parallel, Phase 1 Clinical Trial to Evaluate the Safety and Tolerability of<br>DA-1726 in Obese Otherwise Healthy Subjects<br>Primary<br>Objective<br>To evaluate the safety and tolerability of DA-1726 in obese but otherwise healthy patients<br>NCT Number NCT06252220<br>Dosing<br>Regimen<br>DA-1726 4mg, 8mg, 16mg, 32mg or Matching<br>Placebo, Sub Q, Once Weekly, No Titration<br>Planned # of<br>Subjects 9 subjects per cohort (6 active : 3 placebo)<br>Future Plan Additional MAD cohorts to explore maximum<br>tolerated dose<br>DA-1726: Phase 1 MAD Clinical Study<br>Subject Disposition<br>Number of subjects (%) Pooled PBO 4 mg 8 mg 16 mg 32 mg<br>Randomized 12 6 6 6 6<br>Completed the Study 10 (83.3%) 6 (100%) 5 (83.3%) 6 (100%) 6 (100%)<br>Early Discontinuation from<br> the Study<br>2 (16.7%) 0 1 (16.7%) 0 0<br>Reason for Study Discontinuation<br>Treatment Related SAE 0 0 0 0 0<br>Non-Treatment Related SAE 0 0 1 (16.7%) * 0 0<br> Others 2 (16.7%) 0 0 0 0<br>* Hospitalization due to a car accident, subject was in a passenger seat. Not related to IP. | |||
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| 9<br>DA-1726: Phase 1 MAD Clinical Study<br>Baseline Characteristics 4mg 8mg 16mg 32mg Pooled PBO Overall<br>Baseline Weight (kg)<br>N 6 6 6 6 12 36<br>Mean 84.35 89.32 95.95 90.43 96.65 92.23<br>Min, Max 71.2, 97.0 74.7, 105.9 84.3, 111.0 75.5, 109.3 72.7, 121.9 71.2, 121.9<br>Baseline Body Mass Index (kg/m2)<br>N 6 6 6 6 12 36<br>Mean 32.6 31.17 35.28 34.03 34.83 33.79<br>Min, Max 30.0, 35.6 30.3, 33.3 30.9, 42.0 30.8, 37.8 30.7, 45.3 30.0, 45.3<br>Baseline Waist Circumference (cm)<br>N 6 6 6 6 12 36<br>Mean 98.8 102.2 108.0 104.8 108.1 105.0<br>Min, Max 91, 114 97, 107 96, 118 99, 109 88, 132 88, 132<br>Baseline Glucose Mean (mg/dL)<br>104.7 98.7 100.2 97.8 93.4 100.3<br>Baseline Characteristics | |||
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| 10<br>DA-1726: Phase 1 Safety Highlights (32 mg Dose)<br>• Safety & Tolerability<br>✓ Most GI related AEs occurred after the 1st dose and resolved within 24 hours from occurrence<br>✓ No treatment-related discontinuations<br>✓ Mild vomiting occurred with 3 subjects but resolved within 9 hours, 2 subjects after 1st dose with no reoccurrence<br>✓ Mild nausea occurred with 2 subjects after the 1st dose but resolved within 12 hours, no nausea after 2nd to the last dose<br>✓ Constipation occurred with 2 subjects and resolved within 3 days<br>✓ Abdominal distension with 1 subject and resolved in 14 hours<br>✓ No diarrhea reported<br>✓ Mean heart rate showed slight decrease from baseline in all treatment groups other than the 16 mg cohort (baseline was<br>significantly lower than other cohorts)<br>✓ No clinically significant increases in QTcF were noted and no drug-induced cardiovascular effects were observed at 4 weeks<br>❖ With no titration, 1st dose acted as the “titration” dose which will allow for predictive AE events resulting in increased tolerability<br>• Notable AE<br>✓ Early satiety, suggesting efficacy of GLP-1R, was observed in five out of six subjects receiving the 32 mg dose<br>✓ Most subjects reported this AE after 3rd dosing, only one subject reporting after the 2nd dose<br>❖ These findings suggest greater weight loss may be seen in longer duration studies<br>❖ Further suggesting glucagon may have been the weight loss driver during the first 2 weeks | |||
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| 11<br>DA-1726: Phase 1 MAD Safety<br>GI Treatment Emergent Adverse Events, by Severity<br>GI Treatment Emergent Adverse Events<br>Number of subjects reporting (%)<br>Pooled PBO<br>n = 12<br>Pooled DA1726<br>n = 24<br>4 mg<br>n = 6<br>8 mg<br>n = 6<br>16 mg<br>n = 6<br>32 mg<br>n = 6<br>Gastrointestinal disorders 1 (8.3%) 6 (25.0%) 1 (16.7%) 0 1 (16.7%) 4 (66.7%)<br>Mild 1 (8.3%) 5 (20.8%) 1 (16.7%) 0 0 4 (66.7%)<br>Moderate 0 1 (4.2%) 0 0 1 (16.7%) 0<br>Severe 0 0 0 0 0 0<br>Vomiting 1 (8.3%) 4 (16.7%) 0 0 1 (16.7%) 3 (50.0%)<br>Mild 1 (8.3%) 3 (12.5%) 0 0 0 3 (50.0%)<br>Moderate 0 1 (4.2%) 0 0 1 (16.7%) 0<br>Severe 0 0 0 0 0 0<br>Nausea 1 (8.3%) 3 (12.5%) 0 0 1 (16.7%) 2 (33.3%)<br>Mild 1 (8.3%) 2 (8.3%) 0 0 0 2 (33.3%)<br>Moderate 0 1 (4.2%) 0 0 1 (16.7%) 0<br>Severe 0 0 0 0 0 0<br>Constipation 0 3 (12.5%) 1 (16.7%) 0 0 2 (33.3%)<br>Mild 0 3 (12.5%) 1 (16.7%) 0 0 2 (33.3%)<br>Moderate 0 0 0 0 0 0<br>Severe 0 0 0 0 0 0<br>Abdominal distension 0 1 (4.2%) 0 0 0 1 (16.7%)<br>Mild 0 1 (4.2%) 0 0 0 1 (16.7%)<br>Moderate 0 0 0 0 0 0<br>Severe 0 0 0 0 0 0 | |||
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| 12<br>DA-1726: Phase 1 MAD Topline Body Weight Loss<br>• Day 26 shown dose dependent and compelling BWL shown in 8 mg, 16 mg and 32 mg<br>-4.5%<br>-4.0%<br>-3.5%<br>-3.0%<br>-2.5%<br>-2.0%<br>-1.5%<br>-1.0%<br>-0.5%<br>0.0%<br>% Change from Baseline<br>Maximum Change in BW -2.9% -6.9% -6.1% -6.0% -6.3%<br>% Change in mean BW -1.1% -3.2% -1.7% -3.0% -4.3%<br>kg Change in mean BW -2.7 kg -1.6 kg -2.9 kg -4 kg<br>Placebo Adjusted -2.1% -0.6% -1.8% -3.1%<br>p-Value vs. Placebo 0.0187 0.6740 0.0217 0.0005<br>* p<0.05 ** p<0.001<br>Baseline BW (kg) 96.7 84.4 89.3 96.0 90.4<br>*<br>*<br>** | |||
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| 13<br>DA-1726: MAD Cohort 1-4 - Changes in BMI | |||
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| 14<br>DA-1726: Phase 1 MAD Key Secondary and Exploratory Results (32mg Dose)<br>• Glucose Lowering<br>✓ With mean baseline of 97.8 mg/dL, mean -5.3 mg/dL at Day 26 with maximum -18 mg/dL at Day 26<br>✓ No sign of increase of glucose despite the dual MOA in any cohorts<br>❖ Signs of very strong GLP-1 efficacy with DA-1726 unique GLP-1R/GCGR = 3:1 ratio<br>❖ Potentially best-in-class for GLP-1R/GCGR dual agonist<br>• Waist Circumference<br>✓ With mean baseline of 104.8 cm (41in), Mean -4 cm (1.6in) at Day 33 with maximum of -10 cm (3.9in) at Day 33<br>✓ Mean -3.7 cm at Day 47 may indicate sustainable waist circumferences<br>❖ Signs of very strong Glucagon efficacy with DA-1726 unique GLP-1/GCGR = 3:1 ratio<br>❖ Potentially best-in-class for GLP-1R and GLP-1R/GCGR dual agonists<br>• Early Satiety (AE, n=5)<br>✓ 4 subjects reported early satiety after 3rd and 4th dosing, 1 subject after the 2nd dosing<br>✓ This indicates more weight loss may be expected with longer treatment<br>• Pharmacokinetics<br>✓ All MAD cohorts showed favorable and dose proportional increase of exposure | |||
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| 15<br>DA-1726: Comparative Study with Survodutide on Fat Mass Loss<br>• DA-1726 demonstrated superior weight loss efficacy compared to Survodutide in HF-DIO mice under similar dietary intake<br>conditions<br>• DA-1726 demonstrated superior body fat mass reduction and lean body mass relative preservation compared to Survodutide<br>• The increase in beige or brown adipose-like cells in white adipose tissue by DA-1726 supports the mechanism of enhanced<br>energy expenditure<br>Browning of White Adipose Tissue<br>41.3%<br>50.1%<br>Survodutide [W0]<br>41.3%<br>50.0%<br>33.6%<br>58.2%<br>Body fat mass (%)<br>Lean body mass (%)<br>Fluid (%)<br>Survodutide [W2]<br>39.4%<br>51.5%<br>Body fat mass (%)<br>Lean body mass (%)<br>Fluid (%)<br>DA-1726 Survodutide<br>HF control Blue arrows:<br>browning-like adipocytes<br>Magnification: x200<br>HF control<br>Survodutide, 30 nmol/kg/QD<br>DA-1726, 60 nmol/kg/QD<br>Days of injection<br>0<br>60<br>70<br>80<br>90<br>100<br>110<br>*<br>%<br>3 6 9 12 15 18<br>Change in BW from baseline<br>Body Weight Loss DA-1726 [W0] DA-1726 [W2]<br>Notes: HF-DIO (High Fat-Diet Induced Obesity), EE (energy expenditure), BAT (brown adipose tissue)<br>1. Tae-Hyoung Kim et al. 84th Meeting of the American Diabetes Association. 2024; Abstract 2058-LB.<br>2. All treatments given daily for three weeks.<br>3. Browning of white adipose tissue analyzed using epididymal fat.<br>Mean SEM, *P<0.05 vs. Day 0 in treatment group,<br>#P<0.05 vs. HF control at final time, Two-way RM<br>ANOVA | |||
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| 16<br>6.75<br>5*<br>3.88* 3.63*<br>0<br>1<br>2<br>3<br>4<br>5<br>6<br>7<br>NASH Control Semaglutide<br>250 nmol/kg*<br>DA-1726<br>100 nmol/kg*<br>DA-1726<br>200 nmol/kg*<br>Score<br>• DA-1726 further improved hepatic steatosis, inflammation, and fibrosis compared to semaglutide<br>▪ Animals: male DIO-NASH mice<br>▪ Regimen: Every three days S.C. injection<br>▪ Dose: 100 & 200 nmol/kg DA-1726 vs. 250 nmol/kg semaglutideM<br>Steatosis & Inflammation (HE Staining)<br>DA-1726, 100 nmol/kg<br>Notes: NASH (Non-Alcoholic Steatohepatitis); DIO (Diet Induced Obesity); S.C. (Subcutaneous); NAFLD (Non-Alcoholic Fatty Liver<br>Disease); HE (Hematoxylin and Eosin); MT (Masson’s Trichrome).<br>1. Dong-A Study Report 104854.<br>2. Jung IH et al. 82nd Meeting of the American Diabetes Association. 2022; Abstract 1333-P.<br>30-week<br>GAND Feeding s.c. Injection, every 3 days<br>5-week<br>C57BL/6 Mouse 9-Week<br>NAFLD Activity Score<br>Fibrosis (MT Staining)<br>DA-1726, 200 nmol/kg<br>DIO-NASH Control Semaglutide, 250 nmol/kg DIO-NASH Control Semaglutide, 250 nmol/kg<br>DA-1726, 100 nmol/kg DA-1726, 200 nmol/kg<br>Liver Triglycerides<br>Arrow: Inflammation Blue Color: Fibrosis<br>79.7<br>63.8* 61.3*<br>54.1*<br>0<br>10<br>20<br>30<br>40<br>50<br>60<br>70<br>80<br>90<br>NASH Control Semaglutide<br>250 nmol/kg*<br>DA-1726<br>100 nmol/kg*<br>DA-1726<br>200 nmol/kg*<br>Liver Triglycerides<br>(mg/g wet liver)<br>*Statistically significant compared to control<br>DA-1726: GLP-1R/GCGR Potential in MASH | |||
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| 17<br>Recent Obesity Drug Transactions<br>Companies Date Stage Description Drug Deal Structure Deal Terms<br>Novo Nordisk /<br>United<br>Biotechnology<br>March 2025 Phase 1<br>Ready GLP-1, GIP and Glucagon UBT251<br>Global License, excluding<br>Chinese mainland, Hong<br>Kong, Macau, or Taiwan<br>$200 million up front, with up to $1.8<br>billion in milestone payments<br>AbbVie / Gubra March 2025 Phase 1 Long-acting amylin analog GUB01429 Global License<br>$350 million up front, with potential<br>milestone payments up to $1.875<br>billion<br>Roche / Zealand<br>Pharma March 2025 Phase 2<br>Amylin analogue,<br>as stand-alone therapy & in<br>combination with Roche’s<br>incretin, CT-388<br>Petrelintide<br>(ZP8396)<br>Collaboration,<br>Co-Development and<br>Co-Commercialization<br>$1.65 billion up front, with<br>$1.2 billion in milestones linked to<br>Phase 3 and sales-based milestones of<br>$2.4 billion<br>Carmot<br>Therapeutics /<br>Roche<br>January 2024 Phase 1<br>GLP-1/GIP agonist<br> GLP-1<br>GLP-1/GIP<br>CT-388<br>CT-996<br>CT-868<br>M&A $2.7 billion<br>Versanis Bio / Eli<br>Lilly August 2023 Phase 2b Monoclonal antibody Bimagrumab M&A $1.925 billion<br>Inversago Pharma<br>/ Novo Nordisk September 2023 Phase 2 Oral CB1 inverse agonist INV-202 M&A $1.075 billion | |||
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| December 2023<br>NASDAQ: NRBO 18<br>DA-1241<br>Orally Available, Potential<br>First-in-Class GPR119 Agonist for<br>the Treatment of MASH | |||
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| 19<br>▪ DA-1241 is a synthetic drug that binds to GPR119 expressed on the cell<br>surface of liver cells, immune cells (Kupfer cells, macrophages, monocytes),<br>and hepatic astrocytes.<br>▪ Multiple effects are expected by direct action on representative cells<br>involved in pathogenesis.<br>Harrison et al., Clinical Gastroenterology and Hepatology, 2023;21(8):2001-2014<br>DA-1241: Mode of Action<br>MOA Potential Effect<br>Fatty Liver • Inhibition of fatty acid<br>biosynthesis in liver cells • Reduced fat in liver tissue<br>Inflammation<br>• Inhibition of Kupfer cell<br>activation in liver tissue<br>• Inhibition of blood<br>monocyte and macrophage<br>activation<br>• Inhibits the secretion of<br>inflammatory cytokines<br>• Reduces inflammatory cell<br>infiltration<br>Fibrosis • Inhibition of hepatic<br>astrocyte activation<br>• Inhibits the accumulation<br>of fibrotic protein<br>(collagen) in liver tissue<br>1<br>2<br>3<br>1<br>2<br>2<br>3 | |||
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| 20<br>Placebo<br>(N=23)<br>DA-1241<br>50 mg<br>(N=12)<br>DA-1241<br>100 mg<br>(N=22)<br>DA-1241 100mg + Sitagliptin<br>100 mg<br>(N=34)<br>Number of Subjects, n<br>< 30, n (%) 1 (4.3%) 4 (33.3%) 4 (18.2%) 3 (8.8%)<br>Odds Ratio (p value) 10.500<br>(0.0487)<br>5.600<br>(0.1402)<br>2.423<br>(0.4576)<br>DA-1241: Phase 2a Top-Line Results<br>Primary Efficacy Endpoint<br>* Confidence interval excludes 0, suggesting a statistically meaningful difference.<br>LS Mean ALT Changes from Baseline (U/L)<br>*<br>p < 0.051 vs. placebo *<br>p < 0.05 vs. placebo<br>*<br>Placebo<br>(N=23) 95% CI<br>DA-1241<br>50 mg<br>(N=12)<br>95% CI<br>DA-1241<br>100 mg<br>(N=22)<br>95% CI<br>100mg + Sita<br>100 mg<br>(N=34)<br>95% CI<br>Baseline<br>Mean<br>68.4 65.8 57.2 63.2<br>Week 16 LS<br>Mean<br>-4.70 (-14.05, 4.65) -16.81 (-29.72, -3.89)* -18.09 (-27.67, -8.52)* -8.24 (-15.91, -0.57)*<br>Proportion of Subjects with Normalized ALT <30 IU/L at Week 16<br>* | |||
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| 21<br>DA-1241: Phase 2a Top-Line Results<br>LS Mean ALT Changes from Baseline (U/L)<br>-4.7<br>-16.81<br>-18.09<br>-8.24<br>-20<br>-18<br>-16<br>-14<br>-12<br>-10<br>-8<br>-6<br>-4<br>-2<br>0<br>Alanine Aminotransferase CFB @ W16 (U/L)<br>68.4 65.8 57.2 63.2<br>-4.7<br>-16.81<br>-18.09<br>-8.24<br>-23<br>-18<br>-13<br>-8<br>-3<br>2<br>PBO 50mg 100mg Combi<br>ALT CFB vs. Time (U/L)<br>Week 4 Week 8 Week 16<br>68.4 65.8 57.2 63.2<br>PBO 50 mg 100 mg Combi<br>Primary Efficacy Endpoint<br>*<br>p < 0.051 vs. placebo *<br>p < 0.05 vs. placebo<br>*<br>*<br>*<br>*<br>* | |||
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| 22<br>DA-1241: Phase 2a Top-Line Results<br>LS Mean CAP, FAST, HbA1c score Changes from Baseline at Week 16<br>Select Secondary Efficacy Endpoint<br>*<br>p < 0.05 vs. placebo<br>*<br>-0.09<br>-0.17<br>-0.2 -0.19 -0.19<br>-0.18<br>-0.16<br>-0.14<br>-0.12<br>-0.1<br>-0.08<br>-0.06<br>-0.04<br>-0.02<br>0<br>PBO 50mg 100mg Combi<br>FAST Score CFB<br>347.4 347.3 336.0 344.1 0.555 0.604 0.538 0.564<br>0.1<br>-0.24<br>-0.48<br>-0.52<br>-0.6<br>-0.5<br>-0.4<br>-0.3<br>-0.2<br>-0.1<br>0<br>0.1<br>0.2<br>PBO 50mg 100mg Combi<br>HbA1c CFB (%)<br>6.78 6.58 7.01 6.51<br>*<br>-2.32<br>-8.94<br>-24.32<br>-20.62<br>-30<br>-25<br>-20<br>-15<br>-10<br>-5<br>0<br>PBO 50mg 100mg Combi<br>CAP Score CFB (dB/m)<br>*<br>*<br>* | |||
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| 23<br>DA-1241: Phase 2a Top-Line Results<br>Safety Assessment<br>Overall TEAE Summary<br>N (%) Placebo<br>(N=32)<br>DA-1241 50 mg<br>(N=14)<br>DA-1241 100 mg<br>(N=26)<br>DA-1241 100mg<br>+ Sitagliptin 100 mg<br>(N=36)<br>Subjects with any Treatment Related AE<br> Mild<br> Moderate<br> Severe<br>9 ( 28.1%)<br>8 ( 25.0%)<br>1 ( 3.1%)<br>0<br>4 ( 28.6%)<br>4 ( 28.6%)<br>0<br>0<br>9 ( 34.6%)<br>8 ( 30.8%)<br>1 ( 3.8%)<br>0<br>10 ( 27.8%)<br>9 ( 25.0%)<br>1 ( 2.8%)<br>0<br>Subjects with any Treatment related SAE 0 0 0 0<br>Subjects with any TEAE leading to<br>study discontinuation 0 0 0 1 ( 3.1%)<br>Subjects with any TEAE leading to<br>study drug discontinuation 1 ( 3.1%) 0 0 0 | |||
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| December 2023<br>NASDAQ: NRBO 24<br>Financials<br>and<br>Capitalization | |||
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| 25<br>Cash Balance and Capitalization Table<br>Financial Snapshot As of December 31, 2024<br>Cash $16.0 million<br>Debt None<br>Capitalization Table as of December 31, 2024 Common Stock Equivalents<br>Common Stock 8,637,132<br>Warrants (WAEP $5.54)(1) 14,483,792<br>Options (WAEP $398.30) 4,700<br>Restricted Stock Units 175,086<br>Fully Diluted 23,300,710<br>1. Includes (i) 2024 Series A milestone based warrants to purchase 5,089,060 shares with an exercise price of $3.93 per share, which expire on June 14, 2025 following the release of positive Phase I MAD data for DA-1726,<br>which occurred on April 15, 2025; (ii) 2024 Series B milestone based warrants to purchase 7,633,591 shares with an exercise price of $3.93 per share; (iii) 2024 Pre-Funded warrants to purchase 1,430,000 shares with an<br>exercise price of $0.001 per share, which were fully exercised on April 15, 2025; (iv) 2024 Placement Agent warrants to purchase 127,227 shares of with an exercise price of $4.9125 per share; (v) 2022 Series B warrants to<br>purchase 177,938 shares with an assumed exercise price of $0.00 per share; and (vi) 2021 and prior warrants to purchase a total of 25,976 shares with an weighted average exercise price of $1,142.52 per share. No ratchets,<br>price resets or anti-dilution provisions.<br>Shareholder Common Stock %<br>Dong-A ST Co., Ltd<br>(KOSE:A170900) 5,347,792 62% | |||
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| 26<br>Compelling Investment Opportunity<br>Targeting Obesity and MASH with a Pipeline of Next Generation Therapeutics<br>▪ Aiming to increase Shareholder Value through Multiple, Near-Term, Value Creating Milestones<br>• DA-1726<br>✓ With strong weight loss at 4 weeks, potentially best-in-class tolerability and compelling safety with potential pathway to not only<br>obese otherwise healthy patients but also obese T2D and obese MASH patients<br>✓ 32 mg (not the max dose) with no titration showed max weight loss of -6.3% (15.4 lbs.) and mean weight loss of -4.3% at Day 26<br>✓ Potentially best-in-class lowering of fasted glucose of -5.3 mg/dL and maximum of -18 mg/dL at Day 26 at 32 mg dose with<br>strong signals of GLP-1R efficacy<br>✓ Potentially best-in-class waist circumference reduction with mean of 1.6 inches and maximum of 3.9 inches at Day 33 at 32 mg<br>dose with strong signals of GCGR efficacy<br>✓ No treatment-related discontinuations, with mild GI related AEs at 32 mg dose<br>o Phase 1 Part 3 to explore Wegovy® early drop-out patients on tolerability, weight loss and other end points<br>o Additional cohort(s) are being added to Part 1 (SAD) and Part 2 (MAD) to explore maximum tolerable dose<br>• DA-1241<br>✓ Phase 2a top-line data in subjects with presumed MASH met primary end point and showed direct hepatic effects<br>✓ With added significant reductions in HbA1C from baseline at 100 mg dosing at Week 16 compared to the placebo group<br>o Other exploratory end points including MRI-PDFF to be released at major medical conferences<br>o Will be actively searching for a combination/licensing partner | |||
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| December 2023<br>NASDAQ: NRBO 27<br>Thank You!<br>Investor Contacts:<br>Rx Communications Group<br>Michael Miller<br>+1 917.633.6086<br>mmiller@rxir.com<br>MetaVia<br>Marshall Woodworth<br>+1 919.749.8748<br>marshall.woodworth@metaviatx.com | |||
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| December 2023<br>NASDAQ: NRBO 28<br>Appendix | |||
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| 29<br>DA-1726: Phase 1 MAD Heart Rate<br>Day 8 Day 15 Day 22 Day 29<br>Mean HR<br>change<br>4mg (82.8 bpm) -15.7 -17.2 -9.7 -13.2 -14.0<br>8mg (77.7 bpm) -4 -6 -5.4 -6 -5.4<br>16mg (58.8 bpm) 6 9.5 7.7 7.5 7.7<br>32mg (70.7 bpm) 0.2 -3.5 1.7 -1.3 -0.7<br>Pooled Placebo (67.6 bpm) -3 -4 -4.4 0.7 -2.7<br>• Activation of either the GLP-1 or glucagon receptors is known to increase heart rate<br>• Mean heart rate of DA-1726 showed slight decrease from baseline in all treatment groups other than the 16 mg<br>cohort where the baseline was significantly lower than other cohorts<br>• Mean decrease after 4 weeks was -14 to -0.7 beats per min (bpm) in the DA-1726 cohorts (4, 8 or 32 mg once<br>weekly) while increase of 7.7 bpm for DA-1726 16 mg cohort<br>• No clinically significant increases in QTcF were noted and no drug-induced cardiovascular effects were observed at<br>4 weeks | |||
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