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What changed in MetaVia Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of MetaVia Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+499 added−444 removedSource: 10-K (2026-03-26) vs 10-K (2025-03-20)

Top changes in MetaVia Inc.'s 2025 10-K

499 paragraphs added · 444 removed · 396 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

187 edited+42 added−12 removed166 unchanged
Biggest changeIn November 2024, we completed the last patient last visit for the Phase 2a clinical trial. o In December 2024, we an nounced positive top-line 16-week results from the two-part Phase 2a clinical trial in patients with presumed MASH. o We are expecting to finalize the Clinical Study Report (“ CSR”) of the Phase 2a clinical trial in the first half of 2025. ● DA-1726 is a novel oxyntomodulin (“OXM”) analogue functioning as a GLP-1 receptor (“GLP1R”) and glucagon receptor (“GCGR”) dual agonist for the treatment of obesity that is designed to be administered once weekly subcutaneously.
Biggest changeIn November 2024, we completed the last patient last visit for the Phase 2a clinical trial. o In December 2024, we an nounced positive topline 16-week results from the two-part Phase 2a clinical trial in patients with presumed MASH. o In May 2025, we presented the topline 16-week results from the two-part Phase 2a clinical trial at the European Association for the Study of the Liver (“EASL”) 2025. o In November 2025, we presented sub-group analysis on glucose control in prediabetes and diabetes subjects and additional data on inflammation and lipidomic profiles at the American Association for the Study of Liver Diseases (“AASLD”) The Liver Meeting ® 2025. o We are expecting to finalize the Clinical Study Report (“ CSR”) of the Phase 2a clinical trial in the first half of 2026. ● DA-1726 is a novel oxyntomodulin (“OXM”) analog functioning as a GLP-1 receptor (“GLP1R”) and glucagon receptor (“GCGR”) dual agonist for the treatment of obesity that is designed to be administered once weekly subcutaneously.
Discoveries reported in the scientific literature often lag the actual discoveries, and patent applications in the U.S. and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all.
Discoveries reported in the scientific literature often lag the actual discoveries, and patent applications in the U.S. and other jurisdictions and are typically not published until 18 months after filing, or in some cases not at all.
FDA Regulation In the U.S., pharmaceutical products are subject to regulation by the FDA. The Federal Food, Drug, and Cosmetic Act (“FDCA”) and other federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products.
U.S. FDA Regulation In the U.S., pharmaceutical products are subject to regulation by the FDA. The Federal Food, Drug, and Cosmetic Act (“FDCA”) and other federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products.
Clinical trials must be conducted: (i) in compliance with federal regulations, (ii) in compliance with good clinical practice (“GCP”), an international standard meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators and monitors (some of which have been codified into U.S. federal regulations), and (iii) under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated.
Clinical trials must be conducted: (i) in compliance with federal regulations, (ii) in compliance with good clinical practice (“GCP”), an international standard meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators and monitors (some of which have been codified into U.S. federal regulations), and (iii) under protocols detailing the objectives of the clinical trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated.
The trial protocol and informed consent information for patients in clinical trials must also be submitted to an institutional review board (“IRB”) at each site where a trial will be conducted for approval.
The clinical trial protocol and informed consent information for patients in clinical trials must also be submitted to an institutional review board (“IRB”) at each site where a clinical trial will be conducted for approval.
Since the NIH's Final Rule on ClinicalTrials.gov registration and reporting requirements became effective in 2017, both NIH and FDA have signaled the government's willingness to begin enforcing those requirements against clinical trial sponsors who fail to meet those legal obligations, with FDA releasing a guidance document in August 2020 for certain procedural steps it intends to take when determining whether and how to assess civil monetary penalties against a non-compliant party.
Since the NIH’s Final Rule on ClinicalTrials.gov registration and reporting requirements became effective in 2017, both NIH and FDA have signaled the government’s willingness to begin enforcing those requirements against clinical trial sponsors who fail to meet those legal obligations, with the FDA releasing a guidance document in August 2020 for certain procedural steps it intends to take when determining whether and how to assess civil monetary penalties against a non-compliant party.
As part of the marketing application process when seeking approval for a new drug through an NDA, applicants are required to list with the FDA every patent of which claims cover the applicant's product or an approved method of using the product.
As part of the marketing application process when seeking approval for a new drug through a NDA, applicants are required to list with the FDA every patent of which claims cover the applicant’s product or an approved method of using the product.
A Section 505(b)(2) applicant may eliminate the need to conduct certain preclinical or clinical studies, if it can establish that reliance on studies conducted for a previously approved product is scientifically appropriate. The FDA may also require companies to perform additional trials or measurements to support the change from the approved product.
A Section 505(b)(2) applicant may eliminate the need to conduct certain preclinical or clinical studies, if it can establish that reliance on studies conducted for a previously approved product is scientifically appropriate. The FDA may also require companies to perform additional clinical trials or measurements to support the change from the approved product.
However, only in some cases is a 505(b)(2) NDA-approved drug product determined by FDA to be therapeutically equivalent to the original innovator RLD. As part of our own marketing application process, the ANDA/505(b)(2) applicant is required to certify to the FDA concerning any patents listed for the relevant RLD in the FDA's Orange Book.
However, only in some cases is a 505(b)(2) NDA-approved drug product determined by the FDA to be therapeutically equivalent to the original innovator RLD. As part of our own marketing application process, the ANDA/505(b)(2) applicant is required to certify to the FDA concerning any patents listed for the relevant RLD in the FDA’s Orange Book.
If the ANDA/505(b)(2) applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of that Paragraph IV certification to the NDA sponsor and patent holders once FDA accepts the ANDA/505(b)(2) application for filing.
If the ANDA/505(b)(2) applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of that Paragraph IV certification to the NDA sponsor and patent holders once the FDA accepts the ANDA/505(b)(2) application for filing.
PBO Baseline Mean (dB/m) 347.4 344.1 ​ 347.3 ​ 336.0 ​ Week 16 LS Mean CAP Score (dB/m) (95% CI) -2.32 (-16.17, 11.52) -20.62 (-31.99, -9.26)* 0.0452† -8.94 (-28.08, 10.20) 0.5787 -24.32 (-38.54, -10.10)* 0.0308† Baseline Mean (kPa) 10.00 9.89 ​ 10.71 ​ 10.32 ​ Week 16 LS Mean VCTE Score (kPa) (95% CI) 0.29 (-1.31, 1.89) -1.45 (-2.77, -0.13)* 0.0997 -1.40 (-3.62, 0.83) 0.2257 0.00 (-1.64, 1.64) 0.8051 Baseline Mean 0.555 0.564 ​ 0.604 ​ 0.538 ​ Week 16 LS Mean FAST score (95% CI) -0.09 (-0.17, -0.01)* -0.19 (-0.26, -0.13)* 0.0416† -0.17 (-0.28, -0.06)* 0.2429 -0.19 (-0.27, -0.11)* 0.0704 * Confidence interval excludes 0, suggesting a statistically meaningful difference. † p LS Mean HbA1c Changes from Baseline at Week 16 (%) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Placebo (N=23) DA-1241 100 mg + Sitagliptin 100 mg (N=34) P value vs.
PBO Baseline Mean (dB/m) 347.4 344.1 ​ 347.3 ​ 336.0 ​ Week 16 LS Mean CAP Score (dB/m) (95% CI) -2.32 (-16.17, 11.52) -20.62 (-31.99, -9.26)* 0.0452† -8.94 (-28.08, 10.20) 0.5787 -24.32 (-38.54, -10.10)* 0.0308† Baseline Mean (kPa) 10.00 9.89 ​ 10.71 ​ 10.32 ​ Week 16 LS Mean VCTE Score (kPa) (95% CI) 0.29 (-1.31, 1.89) -1.45 (-2.77, -0.13)* 0.0997 -1.40 (-3.62, 0.83) 0.2257 0.00 (-1.64, 1.64) 0.8051 Baseline Mean 0.555 0.564 ​ 0.604 ​ 0.538 ​ Week 16 LS Mean FAST score (95% CI) -0.09 (-0.17, -0.01)* -0.19 (-0.26, -0.13)* 0.0416† -0.17 (-0.28, -0.06)* 0.2429 -0.19 (-0.27, -0.11)* 0.0704 * Confidence interval excludes 0, suggesting a statistically meaningful difference. † p LS Mean HbA1c Changes from Baseline at Week 16 (%) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Placebo (N=23) Vanoglipel (DA-1241) 100 mg + Sitagliptin 100 mg (N=34) P value vs.
Moreover, the time-in-range, the percentage of how long blood glucose value is within 70~180 mg/dL, was increased by mitigating the hypoglycemia risk and duration of hyperglycemia whereas such time-in-range was reduced in the placebo group. ​ Single administration or 8-week repeated administration of DA-1241 increased secretion of gut peptide hormones such as GLP-1, GIP and PYY in gastrointestinal tracts after taking meals.
Moreover, the time-in-range, the percentage of how long blood glucose value is within 70-180 mg/dL, was increased by mitigating the hypoglycemia risk and duration of hyperglycemia whereas such time-in-range was reduced in the placebo group. ​ Single administration or 8-week repeated administration of vanoglipel (DA-1241) increased secretion of gut peptide hormones such as GLP-1, GIP and PYY in gastrointestinal tracts after taking meals.
DA-1241 Phase 2a Trial We are currently finalizing the CSR on a Phase 2a trial in the U.S. MASH Phase 2a is a 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel arm clinical trial to establish safety and an early signal of efficacy in MASH as a next-generation competitive oral agent while we follow the trend for T2DM.
Vanoglipel (DA-1241) Phase 2a Clinical Trial We are currently finalizing the CSR on a Phase 2a clinical trial in the U.S. MASH Phase 2a is a 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel arm clinical trial to establish safety and an early signal of efficacy in MASH as a next-generation competitive oral agent while we follow the trend for T2DM.
If we terminate, discontinue or suspend, for longer than 12 months, the development of any product listed as a product under development in any development plan provided to Dong-A (other than for reasons of force majeure or requirements of applicable law), then we are deemed in breach of this development obligation, and Dong-A may terminate the 2018 License Agreement for cause after a 60-day cure period.
If we terminate, discontinue or suspend, for longer than 12 months, the development of any product listed as a product under development in any development plan provided to Dong-A ST (other than for reasons of force majeure or requirements of applicable law), then we are deemed in breach of this development obligation, and Dong-A ST may terminate the 2018 License Agreement for cause after a 60-day cure period.
Safety data reviews and dose escalation decisions between cohorts took place after all subjects of an ongoing cohort had completed procedures through day 14. All doses tested were well tolerated. There were no Serious Adverse Events (“SAEs”) and no discontinuations due to Adverse Events (“AEs”). Completed Phase 1b trial in the U.S. T2DM patients.
Safety data reviews and dose escalation decisions between cohorts took place after all subjects of an ongoing cohort had completed procedures through Day 14. All doses tested were well tolerated. There were no serious adverse events (“SAEs”) and no discontinuations due to adverse events (“AEs”). Completed Phase 1b clinical trial in the U.S. T2DM patients.
Corporate Information MetaVia was incorporated under the laws of the State of Delaware in October 2014. Our principal executive offices are located at 545 Concord Avenue, Suite 210, Cambridge, Massachusetts, 02138. Our website address is www.metaviatx.com. The information contained on or that can be accessed through our website is not a part of this report.
Corporate Information MetaVia was incorporated under the laws of the State of Delaware in October 2014. Our principal executive offices are located at 545 Concord Avenue, Suite 210, Cambridge, Massachusetts, 02138. Our website address is www.metaviatx.com. The information contained on or that can be accessed through our website is not a part of this Annual Report.
DA-1241 is a novel chemical drug candidate selectively activating GPR119 which has shown consistent target-related mechanisms and glucose-lowering effects from nonclinical studies in Phase 1b exploratory clinical trials in patients with T2DM in the U.S. GPR119 is known to be a regulator of both blood glucose and lipid levels.
Vanoglipel (DA-1241) is a novel chemical drug candidate selectively activating GPR119 which has shown consistent target-related mechanisms and glucose-lowering effects from nonclinical studies in Phase 1b exploratory clinical trials in patients with T2DM in the U.S. GPR119 is known to be a regulator of both blood glucose and lipid levels.
Our obligation to pay royalties to Dong-A under the 2022 License Agreement continues on a product-by-product and country-by-country basis until the later of (i) the fifth anniversary of the first commercial sale of such product in such country, (ii) the expiration or termination of the last valid patent claim that covers a product in such country and (iii) the loss of regulatory exclusivity for such product in such jurisdiction.
Our obligation to pay royalties to Dong-A ST under the 2022 License Agreement continues on a product-by-product and country-by-country basis until the later of (i) the fifth anniversary of the first commercial sale of such product in such country, (ii) the expiration or termination of the last valid patent claim that covers a product in such country and (iii) the loss of regulatory exclusivity for such product in such jurisdiction.
Among the provisions of the ACA of importance or potential importance to our product candidates are the following: ● an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic products; ● an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program; ● expansion of healthcare fraud and abuse laws, including the False Claims Act and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance; ● a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices; ● extension of manufacturers' Medicaid rebate liability; ● expansion of eligibility criteria for Medicaid programs; ● expansion of the entities eligible for discounts under the Public Health Service Act's pharmaceutical pricing program; ● new requirements to report financial arrangements with physicians and teaching hospitals (i.e., the Federal Physician Payment Sunshine Act, which has since been expanded to cover additional specified healthcare providers); ● a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and ● a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
Among the provisions of the ACA of importance or potential importance to our product candidates are the following: ● an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic products; ● an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program; 36 Table of Contents ● expansion of healthcare fraud and abuse laws, including the False Claims Act and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance; ● a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices; ● extension of manufacturers’ Medicaid rebate liability; ● expansion of eligibility criteria for Medicaid programs; ● expansion of the entities eligible for discounts under the Public Health Service Act’s pharmaceutical pricing program; ● new requirements to report financial arrangements with physicians and teaching hospitals (i.e., the Federal Physician Payment Sunshine Act, which has since been expanded to cover additional specified healthcare providers); ● a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and ● a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
The primary endpoint for SAD Part 1 and MAD Part 2 of our Phase 1 trial is to assess the safety and tolerability of DA-1726 by monitoring AEs, SAEs, TEAEs and AEs leading to treatment discontinuation. Secondary endpoints include the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726.
The primary endpoint for SAD Part 1 and MAD Part 2 of our Phase 1 clinical trial is to assess the safety and tolerability of DA-1726 by monitoring AEs, SAEs, TEAEs and AEs leading to treatment discontinuation. Secondary endpoints include the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726.
Under the terms of the 2018 License Agreement, we obtained an exclusive, royalty-bearing, worldwide (except for the Republic of Korea) license to make, use, offer to sell, sell and import products covered by certain Dong-A intellectual property rights in its proprietary compound designated as DA-9801 (NB-01).
Under the terms of the 2018 License Agreement, we obtained an exclusive, royalty-bearing, worldwide (except for the Republic of Korea) license to make, use, offer to sell, sell and import products covered by certain Dong-A ST intellectual property rights in its proprietary compound designated as DA-9801 (NB-01).
Comprehensive non-clinical studies demonstrated DA-1241 distinctively activates GPR119 across species, stimulates the secretion of insulin and GLP-1, a gut peptide hormone with various metabolic benefits, from the pancreas and intestine, respectively, and thereby reduces postprandial glucose and lipid levels after single administration to mice.
Comprehensive non-clinical studies demonstrated vanoglipel (DA-1241) distinctively activates GPR119 across species, stimulates the secretion of insulin and GLP-1, a gut peptide hormone with various metabolic benefits, from the pancreas and intestine, respectively, and thereby reduces postprandial glucose and lipid levels after single administration to mice.
The postprandial hypoglycemic response by DA-1241 observed in wild type mice disappeared in GPR119-deficient mice, demonstrating target engagement. Notably, DA-1241 treatment did not cause hypoglycemia In diabetic mice with hypertriglyceridemia, chronic treatment with DA-1241 lowered fasting and non-fasting blood glucose levels, in which DA-1241 prevented pancreatic beta cell loss and preserved pancreatic function.
The postprandial hypoglycemic response by vanoglipel (DA-1241) observed in wild type mice disappeared in GPR119-deficient mice, demonstrating target engagement. Notably, vanoglipel (DA-1241) treatment did not cause hypoglycemia In diabetic mice with hypertriglyceridemia, chronic treatment with vanoglipel (DA-1241) lowered fasting and non-fasting blood glucose levels, in which vanoglipel (DA-1241) prevented pancreatic beta cell loss and preserved pancreatic function.
All treatments given as twice weekly injections. 2. Jung I-H et al. 83rd Meeting of the American Diabetes Association. 2023; Abstract 1668-P. Weight loss and plasma biochemistry analysis DA-1726 Phase 1 Trial We are currently conducting a Phase 1 trial in the U.S.
All treatments given as twice weekly injections. 2. Jung I-H et al. 83rd Meeting of the American Diabetes Association. 2023; Abstract 1668-P. Weight Loss and Plasma Biochemistry Analysis DA-1726 Phase 1 Clinical Trial We are currently conducting a Phase 1 clinical trial in the U.S.
Also available on our website is information relating to our corporate governance and our board of directors, including our corporate governance guidelines; our code of business conduct; and our board committee charters. We will provide any of the foregoing information without charge upon written request to our Secretary, MetaVia Inc., 545 Concord Avenue, Suite 210, Cambridge, Massachusetts 02138. ​
Also available on our website is information relating to our corporate governance and our Board of Directors, including our corporate governance guidelines; our code of business conduct; and our board committee charters. We will provide any of the foregoing information without charge upon written request to MetaVia Inc., 545 Concord Avenue, Suite 210, Cambridge, Massachusetts 02138. ​
When a DPP4 inhibitor was cotreated with DA-1241 to prolong the biological half-life of plasma GLP-1, plasma concentrations of active GLP-1 increased more than those due to degradation blockade with DPP4 inhibitors, and thereby potentiation of GLP-1 action further improved glucose and lipid metabolism compared to each treatment alone.
When a DPP4 inhibitor was cotreated with vanoglipel (DA-1241) to prolong the biological half-life of plasma GLP-1, plasma concentrations of active GLP-1 increased more than those due to degradation blockade with DPP4 inhibitors, and thereby potentiation of GLP-1 action further improved glucose and lipid metabolism compared to each treatment alone.
DA-1241 improved hepatic inflammation and fibrosis, showing a decrease in MASLD activity score and relative fibrotic area of the liver compared to the vehicle-treated control. Diet-induced obesity (“DIO”)-MASH mice are chronically induced through a Western diet and are characterized by marked fatty liver and mild to moderate hepatic inflammation/fibrosis.
Vanoglipel (DA-1241) improved hepatic inflammation and fibrosis, showing a decrease in MASLD activity score and relative fibrotic area of the liver compared to the vehicle-treated control. Diet-induced obesity (“DIO”)-MASH mice are chronically induced through a Western diet and are characterized by marked fatty liver and mild to moderate hepatic inflammation/fibrosis.
In DIO-MASH mice, DA-1241 improved hepatic steatosis, inflammation, and fibrosis assessed by histological and biochemical methods regardless of body weight reduction. Of note, DA-1241 improved systemic inflammatory status with reduced plasma inflammatory cytokines (TNFα, IL6) and chemokines (CCL2, CXCL1, CXCL2, CXCL10) contributing to tissue damage.
In DIO-MASH mice, vanoglipel (DA-1241) improved hepatic steatosis, inflammation, and fibrosis assessed by histological and biochemical methods regardless of body weight reduction. Of note, vanoglipel (DA-1241) improved systemic inflammatory status with reduced plasma inflammatory cytokines (TNFα, IL6) and chemokines (CCL2, CXCL1, CXCL2, CXCL10) contributing to tissue damage.
The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. Before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Additionally, the FDA will inspect the facility or the facilities at which the drug is manufactured.
The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. Before approving a NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Additionally, the FDA will inspect the facility or the facilities at which the drug is manufactured.
The Hatch-Waxman Amendments also amended the FDCA to enact Section 505(b)(2) of the FDCA, which permits the filing of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.
The Hatch-Waxman Amendments also amended the FDCA to enact Section 505(b)(2) of the FDCA, which permits the filing of a NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.
Our Strategy Our goal is to discover and develop novel therapeutics designed to impact a range of indications primarily in cardiometabolic diseases. The key elements of our business strategy to achieve this goal include: ● Advance DA-1241 through the FDA regulatory process to obtain approval for the treatment of MASH.
Our Strategy Our goal is to discover and develop novel therapeutics designed to impact a range of indications primarily in cardiometabolic diseases. The key elements of our business strategy to achieve this goal include: ● Advance vanoglipel (DA-1241) through the FDA regulatory process to obtain approval for the treatment of MASH.
Exploratory P1b Study in the U.S.: Glucose-Lowering Effects Mean Change in Postprandial Glucose Excursion at Week 8 In the parameters of glycemic variability measured with a Continuous Glucose Monitoring system and fasting plasma glucose, the glucose-lowering efficacy by DA-1241 was similar to that of sitagliptin.
Exploratory P1b Study in the U.S.: Glucose-Lowering Effects Mean Change in Postprandial Glucose Excursion at Week 8 In the parameters of glycemic variability measured with a Continuous Glucose Monitoring system and fasting plasma glucose, the glucose-lowering efficacy by vanoglipel (DA-1241) was similar to that of sitagliptin.
In most countries, including the U.S., the patent term is 20 years from the earliest filing date of a non-provisional patent application or a Patent Cooperation Treaty (“PCT”) application to which a U.S. application claims priority. In the U.S., a patent's term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the U.S.
In most countries, including the U.S., the patent term is 20 years from the earliest filing date of a non-provisional patent application or a Patent Cooperation Treaty application to which a U.S. application claims priority. In the U.S., a patent’s term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the U.S.
PBO Baseline Mean 68.4 63.2 ​ 65.8 ​ 57.2 ​ Week 4 LS Mean (95% CI) -1.51 (-8.23, 5.21) -8.38 (-13.89, -2.87)* 0.1195 -9.63 (-18.90, -0.35)* 0.1622 -13.44 (-20.32, -6.57)* 0.0159† Week 8 LS Mean (95% CI) 0.13 (-7.83, 8.09) -10.27 (-16.80, -3.73)* 0.0479† -11.05 (-22.04, -0.05)* 0.1050 -12.25 (-20.40, -4.10)* 0.0342† Week 16 LS Mean (95% CI) -4.70 (-14.05, 4.65) -8.24 (-15.91, -0.57)* 0.5624 -16.81 (-29.72, -3.89)* 0.1345 -18.09 (-27.67, -8.52)* 0.0506 * Confidence interval excludes 0, suggesting a statistically meaningful difference. † p LS Mean ALT Changes from Baseline (U/L) 10 Table of Contents Notable Secondary Endpoints Proportion of Subjects with Normalized ALT ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Number of Subjects, n Placebo (N=23) DA-1241 100 mg + Sitagliptin 100 mg (N=34) DA-1241 50 mg (N=12) DA-1241 100 mg (N=22) 1 (4.3%) 3 (8.8%) 4 (33.3%) 4 (18.2%) Odds Ratio (p value) ​ 2.423 (0.4576) 10.500† (0.0487)† 5.600 (0.1402) † p LS Mean CAP, VCTE, FAST score Changes from Baseline at Week 16 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Placebo (N=23) DA-1241 100 mg + Sitagliptin 100 mg (N=34) P value vs.
PBO Baseline Mean 68.4 63.2 ​ 65.8 ​ 57.2 ​ Week 4 LS Mean (95% CI) -1.51 (-8.23, 5.21) -8.38 (-13.89, -2.87)* 0.1195 -9.63 (-18.90, -0.35)* 0.1622 -13.44 (-20.32, -6.57)* 0.0159† Week 8 LS Mean (95% CI) 0.13 (-7.83, 8.09) -10.27 (-16.80, -3.73)* 0.0479† -11.05 (-22.04, -0.05)* 0.1050 -12.25 (-20.40, -4.10)* 0.0342† Week 16 LS Mean (95% CI) -4.70 (-14.05, 4.65) -8.24 (-15.91, -0.57)* 0.5624 -16.81 (-29.72, -3.89)* 0.1345 -18.09 (-27.67, -8.52)* 0.0506 * Confidence interval excludes 0, suggesting a statistically meaningful difference. † p 11 Table of Contents Notable Secondary Endpoints Proportion of Subjects with Normalized ALT ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Number of Subjects, n Placebo (N=23) Vanoglipel (DA-1241) 100 mg + Sitagliptin 100 mg (N=34) Vanoglipel (DA-1241) 50 mg (N=12) Vanoglipel (DA-1241) 100 mg (N=22) 1 (4.3%) 3 (8.8%) 4 (33.3%) 4 (18.2%) Odds Ratio (p value) ​ 2.423 (0.4576) 10.500† (0.0487)† 5.600 (0.1402) † p LS Mean CAP, VCTE, FAST score Changes from Baseline at Week 16 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Placebo (N=23) Vanoglipel (DA-1241) 100 mg + Sitagliptin 100 mg (N=34) P value vs.
The Phase 1b study was designed as a placebo and active comparator (sitagliptin 100 mg)-controlled, double-blind, randomized, multi-center study with an objective of evaluating whether DA-1241 delivers improved glucose-lowering efficacy in 83 diabetic patients.
The Phase 1b study was designed as a placebo and active comparator (sitagliptin 100 mg) controlled, double-blind, randomized, multi-center study with an objective of evaluating whether vanoglipel (DA-1241) delivers improved glucose-lowering efficacy in 83 diabetic patients.
Eight-week treatment of DA-1241 25 mg, 50 mg and 100 mg showed the changes of +6.3%, -2.0% and -13.8% in iAUE levels from the baseline and DA-1241 100 mg showed similar blood glucose improvement with that of sitagliptin 100 mg (-9.0%), and it outperformed placebo (+10.5%).
Eight-week treatment of vanoglipel (DA-1241) 25 mg, 50 mg and 100 mg showed the changes of +6.3%, -2.0% and -13.8% in iAUE levels from the baseline and vanoglipel (DA-1241) 100 mg showed similar blood glucose improvement with that of sitagliptin 100 mg (-9.0%), and it outperformed placebo (+10.5%).
After completion of the required clinical testing, an NDA is prepared and submitted to the FDA. FDA approval of the NDA is required before marketing of the product may begin in the U.S. The NDA must include the results of all preclinical, clinical, and other testing and a compilation of data relating to the product's pharmacology, chemistry, manufacture, and controls.
After completion of the required clinical testing, a NDA is prepared and submitted to the FDA. FDA approval of the NDA is required before marketing of the product may begin in the U.S. The NDA must include the results of all preclinical, clinical, and other testing and a compilation of data relating to the product’s pharmacology, chemistry, manufacture, and controls.
The FDA has 60 days from its receipt of an NDA to determine whether the application will be accepted for filing based on the agency's threshold determination that it is sufficiently complete to permit substantive review. Once the submission is accepted for filing, the FDA begins an in-depth review.
The FDA has 60 days from its receipt of a NDA to determine whether the application will be accepted for filing based on the agency’s threshold determination that it is sufficiently complete to permit substantive review. Once the submission is accepted for filing, the FDA begins an in-depth review.
DA-1241 50 mg showed a statistically significant improvement in the normalization of ALT levels compared to placebo, with an odds ratio of 10.500 (p = 0.0487). ● Direct hepatic effect shown by significant improvements in CAP score and FAST score.
Vanoglipel (DA-1241) 50 mg showed a statistically significant improvement in the normalization of ALT levels compared to placebo, with an odds ratio of 10.500 (p = 0.0487). ● Direct hepatic effect shown by significant improvements in CAP score and FAST score.
The ANDA applicant may also elect to submit a Section VIII statement, certifying that our proposed ANDA or 505(b)(2) labeling does not contain (or carves out) any language regarding the patented method-of-use, rather than certify to a listed method-of-use patent.
The ANDA applicant may also elect to submit a Section VIII statement, certifying that the proposed ANDA or 505(b)(2) labeling does not contain (or carves out) any language regarding the patented method-of-use, rather than certify to a listed method-of-use patent.
Disclosure of the results of these trials can be delayed for up to two years if the sponsor certifies that it is seeking approval of an unapproved product or that it will file an application for approval of a new indication for an approved product within one year.
Disclosure of the results of these clinical trials can be delayed for up to two years if the sponsor certifies that it is seeking approval of an unapproved product or that it will file an application for approval of a new indication for an approved product within one year.
Either Dong-A or we may terminate the 2018 License Agreement if the other party is in material breach of the 2018 License Agreement and has not cured or started to cure the breach within 60 days of notice of such breach, or is subject to a bankruptcy or insolvency event.
Either Dong-A ST or we may terminate the 2018 License Agreement if the other party is in material breach of the 2018 License Agreement and has not cured or started to cure the breach within 60 days of notice of such breach, or is subject to a bankruptcy or insolvency event.
Non-clinical studies suggest DA-1241 selectively activates GPR119, stimulates the secretion of insulin and incretin hormones such as GLP-1, and thereby reduces plasma glucose levels without hypoglycemia risk and lowers plasma lipids levels of both triglycerides and cholesterol.
Non-clinical studies suggest vanoglipel (DA-1241) selectively activates GPR119, stimulates the secretion of insulin and incretin hormones such as GLP-1, and thereby reduces plasma glucose levels without hypoglycemia risk and lowers plasma lipids levels of both triglycerides and cholesterol.
Orphan Drugs Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition generally a disease or condition that affects fewer than 200,000 individuals. The U.S. Orphan Drug Designation must be requested before submitting an NDA.
Orphan Drugs Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition generally a disease or condition that affects fewer than 200,000 individuals. The U.S. Orphan Drug Designation must be requested before submitting a NDA.
DA-1241 100 mg and DA-1241 100 mg in combination with Sitagliptin 100 mg showed significant reductions in HbA1c from baseline at Week 16 compared to the placebo group (p = 0.0179 and p = 0.0050, respectively). ● Strong safety signal compared to competition.
Vanoglipel (DA-1241) 100 mg and vanoglipel (DA-1241) 100 mg in combination with Sitagliptin 100 mg showed significant reductions in HbA1c from baseline at Week 16 compared to the placebo group (p = 0.0179 and p = 0.0050, respectively). ● Strong safety signal compared to competition.
According to its performance goals, the FDA seeks to evaluate the protocol within 45 days of the request to assess whether the proposed trial is adequate, and that evaluation may result in discussions and a request for additional information.
According to its performance goals, the FDA seeks to evaluate the protocol within 45 days of the request to assess whether the proposed clinical trial is adequate, and that evaluation may result in discussions and a request for additional information.
While we focus our financial resources and management’s attention on the development of DA-1241 and DA-1726, we also have four legacy therapeutic programs designed to impact a range of indications in viral, neurodegenerative and cardiometabolic diseases which we are not planning to advance development on and continue to consider for out-licensing and divestiture opportunities : ● ANA001, a proprietary oral niclosamide formulation for the treatment of patients with moderate COVID-19. ● NB-01 for the treatment for painful diabetic neuropathy (“PDN”).
While we focus our financial resources and management’s attention on the development of vanoglipel (DA-1241) and DA-1726, we also have four legacy therapeutic programs designed to impact a range of indications in viral, neurodegenerative and cardiometabolic diseases, which we are not planning to advance development on and have, or continue to consider for, out-licensing and divestiture opportunities: ● ANA001, a proprietary oral niclosamide formulation for the treatment of patients with moderate COVID-19. ● NB-01 for the treatment for painful diabetic neuropathy (“PDN”).
DA-1241 100 mg showed statistically significant reductions in ALT levels at weeks 4 and 8 (p = 0.0159 and p = 0.0342, respectively) and a near statistically significant reduction (p = 0.0506) at week 16 compared to placebo. ● Normalized ALT levels in 16 weeks.
Vanoglipel (DA-1241) 100 mg showed statistically significant reductions in ALT levels at Weeks 4 and 8 (p = 0.0159 and p = 0.0342, respectively) and a near statistically significant reduction (p = 0.0506) at Week 16 compared to placebo. ● Normalized ALT levels in 16 weeks.
Patent and Trademark Office must determine that approval of the drug covered by the patent for which a patent extension is being sought is likely. Interim patent extensions are not available for a drug for which an NDA has not been submitted.
Patent and Trademark Office must determine that approval of the drug covered by the patent for which a patent extension is being sought is likely. Interim patent extensions are not available for a drug for which a NDA has not been submitted.
There are several product candidates in Phase 3 or earlier clinical or preclinical development for the treatment of MASH, including Novo Nordisk’s GLP1R agonist semaglutide, Eli Lilly’s GLP1R and GIP dual agonist tirzepatide, Akero Therapeutics’s FGF21 analog efruxifermin, 89 Bio’s FGF21 analog pegaozafermin, Inventiva’s pan-peroxisome proliferator-activated receptor agonist, Boston Pharmaceuticals and Roche’s fibroblast growth factor 21 analogs, and farnesoid X receptor agonists from Intercept Pharmaceuticals Inc., among others.
There are several product candidates in Phase 3 or earlier clinical or preclinical development for the treatment of MASH, including Novo Nordisk’s GLP1R agonist semaglutide, Eli Lilly’s GLP1R and GIP dual agonist tirzepatide, Akero Therapeutics’ FGF21 analog efruxifermin, 89 Bio’s FGF21 analog pegaozafermin, Inventiva’s pan-peroxisome proliferator-activated receptor agonist, Boston Pharmaceuticals and Roche’s fibroblast growth factor 21 analogs, and farnesoid X receptor agonists from Intercept Pharmaceuticals Inc., among others.
DA-1241 was shown to be very well tolerated with mostly mild AEs and no drug related SAEs in the treatment groups with no treatment emergent adverse events (“TEAEs”) leading to study drug discontinuation.
Vanoglipel (DA-1241) was shown to be very well tolerated with mostly mild AEs and no drug-related SAEs in the treatment groups with no treatment emergent adverse events (“TEAEs”) leading to study drug discontinuation.
Phase 2 usually involves trials in a limited patient population to determine the effectiveness of the drug for a particular indication, dosage tolerance and optimum dosage, and to identify common adverse effects and safety risks.
Phase 2 usually involves clinical trials in a limited patient population to determine the effectiveness of the drug for a particular indication, dosage tolerance and optimum dosage, and to identify common adverse effects and safety risks.
An SPA request must be made before the proposed trial begins, and all open issues must be resolved before the trial begins. If a written agreement is reached, it will be documented and made part of the administrative record.
An SPA request must be made before the proposed clinical trial begins, and all open issues must be resolved before the clinical trial begins. If a written agreement is reached, it will be documented and made part of the administrative record.
Primary Efficacy Endpoint LS Mean ALT Changes from Baseline (U/L) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Placebo (N=23) DA-1241 100 mg + Sitagliptin 100 mg (N=34) P value vs. PBO DA-1241 50 mg (N=12) P value vs. PBO DA-1241 100 mg (N=22) P value vs.
Primary Efficacy Endpoint LS Mean ALT Changes from Baseline (U/L) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Placebo (N=23) Vanoglipel (DA-1241) 100 mg + Sitagliptin 100 mg (N=34) P value vs. PBO Vanoglipel (DA-1241) 50 mg (N=12) P value vs. PBO Vanoglipel (DA-1241) 100 mg (N=22) P value vs.
Upon approval of a drug, approval information about the drug along with each of the applicant's listed patents is then published in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations , commonly known as the "Orange Book." Pursuant to the Hatch-Waxman Amendments, drugs listed in the Orange Book can, in turn, be cited by potential generic competitors in support of approval of an abbreviated new drug application (“ANDA”).
Upon approval of a drug, approval information about the drug along with each of the applicant’s listed patents is then published in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations , commonly known as the “Orange Book.” Pursuant to the Hatch-Waxman Amendments, drugs listed in the Orange Book can, in turn, be cited by potential generic competitors in support of approval of an abbreviated new drug application (“ANDA”).
The cost of preparing and submitting an NDA is substantial. Under federal law, the submission of most NDAs is additionally subject to a substantial application user fee.
The cost of preparing and submitting a NDA is substantial. Under federal law, the submission of most NDAs is additionally subject to a substantial application user fee.
Changes to the manufacturing process, specifications or container closure system for an approved drug are strictly regulated and often require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from GMP and impose reporting and documentation requirements upon the sponsor and others involved in the drug manufacturing process.
Changes to the manufacturing process, specifications or container closure system for an approved drug are strictly regulated and often require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting and documentation requirements upon the sponsor and others involved in the drug manufacturing process.
With respect to listed patents, patent certification requirements, and the blocking of follow-on marketing applications for the drug product previously approved under an NDA and listed in the Orange Book-known as the RLD-505(b)(2) NDA applications and ANDAs are required under the statute and FDA's implementing regulations to follow similar procedures and are subject to similar conditions.
With respect to listed patents, patent certification requirements, and the blocking of follow-on marketing applications for the drug product previously approved under a NDA and listed in the Orange Book known as the RLD-505(b)(2) NDA applications and ANDAs are required under the statute and FDA’s implementing regulations to follow similar procedures and are subject to similar conditions.
With the successful proof of concept demonstrated in the Phase 2a trial, we plan to explore other combination therapies that can benefit from the mechanism of action of DA-1241 and to expand the target efficacy of DA-1241 for the treatment of MASH. ● Advance DA-1726 through the FDA regulatory process to obtain approval for the treatment of obesity.
With the successful proof of concept demonstrated in the Phase 2a clinical trial, we plan to explore other combination therapies that can benefit from the mechanism of action of vanoglipel (DA-1241) and to expand the target efficacy of vanoglipel (DA-1241) for the treatment of MASH. ● Advance DA-1726 through the FDA regulatory process to obtain approval for the treatment of obesity.
Patent and Trademark Office (“USPTO”) in examining and granting a patent, or may be shortened if a patent is terminally disclaimed over an earlier filed patent.
Patent and Trademark Office (the “USPTO”) in examining and granting a patent, or may be shortened if a patent is terminally disclaimed over an earlier filed patent.
Under the terms of the 2022 License Agreement, Dong-A (i) received an upfront payment which was settled in 2,200 shares of preferred stock of MetaVia designated as “Series A Convertible Preferred Stock”, par value $0.001 per share (which was subsequently converted into shares of our common stock), under the terms of the Securities Purchase Agreement; (ii) is eligible to receive single digit royalties on net sales received by us from the commercial sale of products covering DA-1241 or DA-1726; (iii) is eligible to receive commercial-based milestone payments, dependent upon the achievement of specific commercial developments; and (iv) is eligible to receive regulatory milestone payments of up to $178.0 million for DA-1726 and $138.0 million for DA-1241, dependent upon the achievement of specific regulatory developments.
Under the terms of the 2022 License Agreement, Dong-A ST (i) received an upfront payment which was settled in 2,200 shares of preferred stock of MetaVia designated as “Series A Convertible Preferred Stock,” par value $0.001 per share (which was subsequently converted into shares of our common stock), under the terms of the Securities Purchase Agreement; (ii) is eligible to receive single digit royalties on net sales received by us from the commercial sale of products covering vanoglipel (DA-1241) or DA-1726; (iii) is eligible to receive commercial-based milestone payments, dependent upon the achievement of specific commercial developments; and (iv) is eligible to receive regulatory milestone payments of up to $178.0 million for DA-1726 and $138.0 million for vanoglipel (DA-1241), dependent upon the achievement of specific regulatory developments.
In addition, drug manufacturers and other entities involved in the manufacture of approved drugs are required to register their facilities with the FDA and state agencies, and are subject to periodic unannounced inspections by the FDA for compliance with GMP requirements. Prescription drug distribution facilities are also subject to state licensure, including inspections, by the relevant local regulatory authority.
In addition, drug manufacturers and other entities involved in the manufacture of approved drugs are required to register their facilities with the FDA and state agencies, and are subject to periodic unannounced inspections by the FDA for compliance with cGMP requirements. Prescription drug distribution facilities are also subject to state licensure, including inspections, by the relevant local regulatory authority.
If these third-party payers do not consider our products to be cost-effective compared to other available therapies, they may not cover our products after approval as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow us to sell our products on a profitable basis.
If these third-party payors do not consider our products to be cost-effective compared to other available therapies, they may not cover our products after approval as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow us to sell our products on a profitable basis.
A complete response letter (CRL) generally outlines the deficiencies in the submission and may require substantial additional testing or information, in order for the FDA to reconsider the application. If, or when, those deficiencies have been addressed to the FDA's satisfaction in a resubmission of the NDA, the FDA will issue an approval letter.
A complete response letter (“CRL”) generally outlines the deficiencies in the submission and may require substantial additional testing or information, in order for the FDA to reconsider the application. If, or when, those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter.
The furthest stage of development of any oxyntomodulin analogue are survudutide and mazdutide in Phase 3 trials in the U.S., mazdutide which is approved in China, and in Phase 2 trial in the U.S. for the treatment of obesity and MASH. DA-1726 Preclinical Development Animal toxicity studies of DA-1726 for the Phase 1 clinical trial have been completed.
The furthest stage of development of any oxyntomodulin analog are survudutide and mazdutide in Phase 3 clinical trials in the U.S., mazdutide which is approved in China, and in Phase 2 clinical trial in the U.S. for the treatment of obesity and MASH. DA-1726 Preclinical Development Animal toxicity studies of DA-1726 for the Phase 1 clinical trial have been completed.
The centralized procedure is compulsory for human drugs that: (i) are derived from biotechnology processes, such as genetic engineering, (ii) contain a new active substance indicated for the treatment of certain diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune and other immune dysfunctions and viral diseases, (iii) are officially designated "orphan drugs" (drugs used for rare human diseases) and (iv) are advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines.
The centralized procedure is compulsory for human drugs that: (i) are derived from biotechnology processes, such as genetic engineering, (ii) contain a new active substance indicated for the treatment of certain diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune and other immune dysfunctions and viral diseases, (iii) are officially designated “orphan drugs” (drugs used for rare human diseases) and (iv) are advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines.
We continue to consider out-licensing and divestiture opportunities with respect to the following legacy programs. ​ ANA001 Treatment of COVID-19 Symptoms ANA001 is a proprietary oral niclosamide formulation that was developed as a treatment for patients with moderate COVID-19 (patients not requiring ventilators) .
We have or continue to consider out-licensing and divestiture opportunities with respect to the following legacy programs. ​ ANA001 Treatment of COVID-19 Symptoms ANA001 is a proprietary oral niclosamide formulation that was developed as a treatment for patients with moderate COVID-19 (patients not requiring ventilators) .
Conditions for exclusivity include the FDA's determination that information relating to the use of a new drug in the pediatric population may produce health benefits in that population, the FDA making a written request for pediatric studies, and the applicant agreeing to perform, and reporting on, the requested studies within the statutory timeframe.
Conditions for exclusivity include the FDA’s determination that information relating to the use of a new drug in the pediatric population may produce health benefits in that population, the FDA making a written request for pediatric studies, and the applicant agreeing to perform, and report on, the requested studies within the statutory timeframe.
Moreover, DA-1241 treatment decreased hepatic lipid accumulation in addition to plasma triglycerides levels at the same dose levels.
Moreover, vanoglipel (DA-1241) treatment decreased hepatic lipid accumulation in addition to plasma triglycerides levels at the same dose levels.
In general, in Phase 1, the initial introduction of the drug into healthy human volunteers or, in some cases, patients, the drug is tested to assess metabolism, pharmacokinetics, pharmacological actions, side effects associated with increasing doses and, if possible, early evidence of effectiveness.
In general, in Phase 1, the initial introduction of the drug into healthy human volunteers or, in some cases, patients, the drug is tested to assess metabolism, PK, pharmacological actions, side effects associated with increasing doses and, if possible, early evidence of effectiveness.
Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain GMP compliance and ensure ongoing compliance with other statutory requirements the FDCA, such as the requirements for making manufacturing changes to an approved NDA.
Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance and ensure ongoing compliance with other statutory requirements of the FDCA, such as the requirements for making manufacturing changes to an approved NDA.
ETASU can include, but is not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring, and the use of patient registries. The requirement for a REMS can materially affect the potential market and profitability of the drug.
ETASU can include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring, and the use of patient registries. The requirement for a REMS can materially affect the potential market and profitability of the drug.
The FDA is responsible for determining that the generic drug is "bioequivalent" to the innovator drug, although under the statute, a generic drug is bioequivalent to a RLD if "the rate and extent of absorption of the drug do not show a significant difference from the rate and extent of absorption of the listed drug." Other than the requirement for bioequivalence testing, ANDA applicants are not required to conduct, or submit results of, preclinical or clinical tests to prove the safety or effectiveness of their drug product.
The FDA is responsible for determining that the generic drug is “bioequivalent” to the innovator drug, although under the statute, a generic drug is bioequivalent to a RLD if “the rate and extent of absorption of the drug do not show a significant difference from the rate and extent of absorption of the listed drug.” Other than the requirement for bioequivalence testing, ANDA applicants are not required to conduct, or submit results of, preclinical or clinical tests to prove the safety or effectiveness of their drug product.
These third-party payers are increasingly challenging the prices charged for medical products and services. Additionally, the containment of health care costs has become a priority of federal and state governments, and the prices of drugs have been a focus in this effort.
These third-party payors are increasingly challenging the prices charged for medical products and services. Additionally, the containment of health care costs has become a priority of federal and state governments, and the prices of drugs have been a focus in this effort.
If a compound demonstrates evidence of effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 trials are undertaken to obtain additional information about clinical efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit the FDA to evaluate the overall benefit-risk relationship of the drug and to provide adequate information for the labeling of the drug.
If a compound demonstrates evidence of effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 clinical trials are undertaken to obtain additional information about clinical efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit the FDA to evaluate the overall benefit-risk relationship of the drug and 27 Table of Contents to provide adequate information for the labeling of the drug.
Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions under a REMS program.
Later discovery of previously unknown problems with a product, including AEs of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions under a REMS program.
MASH Overview MASH is a severe form of metabolic dysfunction-associated steatotic liver disease (“MASLD”) characterized by inflammation and fibrosis in the liver that can progress to cirrhosis, liver failure, hepatocellular carcinoma and death. MASLD was formerly known as nonalcoholic fatty liver disease (“NAFLD”) and was changed by the AASLD and its European and Latin American counterparts.
MASH Overview MASH is a severe form of metabolic dysfunction-associated steatotic liver disease (“MASLD”) characterized by inflammation and fibrosis in the liver that can progress to cirrhosis, liver failure, hepatocellular carcinoma and death. MASLD was formerly known as nonalcoholic fatty liver disease (“NAFLD”) and was changed by the AASLD and its European and Latin American 7 Table of Contents counterparts.
Accelerated evaluation might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of major public health interest from the point of view of therapeutic innovation, defined by three cumulative criteria: the seriousness of the disease to be treated, the absence of an appropriate alternative therapeutic approach, and anticipation of exceptional high therapeutic benefit.
Accelerated evaluation might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of major public health interest from the point of view of therapeutic innovation, defined by three cumulative criteria: (i) the seriousness of the disease to be treated, (ii) the absence of an appropriate alternative therapeutic approach, and (iii) anticipation of exceptional high therapeutic benefit.
DA-1241 MASH There is only one approved treatment of MASH, Madrigal Pharmaceuticals’ thyroid hormone receptor beta agonist. However, various therapeutics are used off-label for the treatment of MASH, including vitamin E (an antioxidant), insulin sensitizers (e.g., metformin, pioglitazone), antihyperlipidemic agents (e.g., gemfibrozil), pentoxifylline and ursodeoxycholic acid (UDCA).
Vanoglipel (DA-1241) and DA-1726 - MASH There is only one approved treatment of MASH, Madrigal Pharmaceuticals’ thyroid hormone receptor beta agonist. However, various therapeutics are used off-label for the treatment of MASH, including vitamin E (an antioxidant), insulin sensitizers (e.g., metformin, pioglitazone), antihyperlipidemic agents (e.g., gemfibrozil), pentoxifylline and ursodeoxycholic acid.
Surrogate endpoints can often be measured more easily or more rapidly than clinical endpoints. A drug candidate approved under Subpart H is subject to rigorous post-marketing 22 Table of Contents compliance requirements, including the completion of Phase 4 or post-approval clinical trials to confirm the effect on the clinical endpoint.
Surrogate endpoints can often be measured more easily or more rapidly than clinical endpoints. A drug candidate approved under Subpart H is subject to rigorous post-marketing compliance requirements, including the completion of Phase 4 or post-approval clinical trials to confirm the effect on the clinical endpoint.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeAmong other things, these provisions: ● establish a classified Board such that not all members of the Board are elected at one time; ● allow the authorized number of our directors to be changed only by resolution of our Board; ● limit the manner in which our stockholders can remove directors from the Board; ● establish advance notice requirements for stockholder proposals that can be acted on at stockholder meetings and nominations to our Board; ● require that stockholder actions must be effected at a duly called stockholder meeting and prohibit actions by our stockholders by written consent; ● prohibit our stockholders from calling special meetings; ● authorize our Board to issue preferred stock without stockholder approval, which preferred stock may include rights superior to the rights of the holders of common stock, and which could be used to institute a shareholder rights plan, or so-called “poison pill,” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our Board; and ● require the approval of the holders of at least two-thirds of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our charter or bylaws. 59 Table of Contents Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with it for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner.
Biggest changeAmong other things, these provisions: ● establish a classified Board such that not all members of the Board are elected at one time; ● allow the authorized number of our directors to be changed only by resolution of our Board; ● limit the manner in which our stockholders can remove directors from the Board; ● establish advance notice requirements for stockholder proposals that can be acted on at stockholder meetings and nominations to our Board; ● require that stockholder actions must be effected at a duly called stockholder meeting and prohibit actions by our stockholders by written consent; ● prohibit our stockholders from calling special meetings; ● authorize our Board to issue preferred stock without stockholder approval, which preferred stock may include rights superior to the rights of the holders of common stock, and which could be used to institute a shareholder rights plan, or so-called “poison pill,” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our Board; and ● require the approval of the holders of at least two-thirds of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our charter or bylaws.
There is no assurance that we will be able to design and complete a clinical trial to support marketing approval. Moreover, nonclinical and clinical data are often susceptible to multiple interpretations and analyses. A number of companies in the pharmaceutical and biotechnology industries have experienced significant setbacks in advanced clinical trials, even after achieving promising results in earlier trials.
There is no assurance that we will be able to design and complete a clinical trial to support marketing approval. Moreover, nonclinical and clinical data are often susceptible to multiple interpretations and analyses. A number of companies in the pharmaceutical and biotechnology industries have experienced significant setbacks in advanced clinical trials, even after achieving promising results in earlier clinical trials.
Successfully completing clinical trials and obtaining approval of an NDA is a complex, lengthy, expensive and uncertain process, and the FDA, or a comparable foreign regulatory authority, may delay, limit or deny approval of an NDA for many reasons, including, among others: (i) disagreement with the design or implementation of our clinical trials; (ii) disagreement with the sufficiency of our clinical trials; (iii) failure to demonstrate the safety and efficacy of the product candidate for the proposed indications; (iv) failure to demonstrate that any clinical and other benefits of the product candidate outweigh their safety risks; (v) a negative interpretation of the data from our nonclinical studies or clinical trials; (vi) insufficient data collected from clinical trials or changes in the approval requirements that render our nonclinical and clinical data insufficient to support the filing of an NDA or to obtain regulatory approval; or (vii) changes in clinical practice in our approved products available for the treatment of the target patient population that could have an impact on the indications that we are pursuing for our product candidates.
Successfully completing clinical trials and obtaining approval of a NDA is a complex, lengthy, expensive and uncertain process, and the FDA, or a comparable foreign regulatory authority, may delay, limit or deny approval of a NDA for many reasons, including, among others: (i) disagreement with the design or implementation of our clinical trials; (ii) disagreement with the sufficiency of our clinical trials; (iii) failure to demonstrate the safety and efficacy of the product candidate for the proposed indications; (iv) failure to demonstrate that any clinical and other benefits of the product candidate outweigh their safety risks; (v) a negative interpretation of the data from our nonclinical studies or clinical trials; (vi) insufficient data collected from clinical trials or changes in the approval requirements that render our nonclinical and clinical data insufficient to support the filing of a NDA or to obtain regulatory approval; or (vii) changes in clinical practice in our approved products available for the treatment of the target patient population that could have an impact on the indications that we are pursuing for our product candidates.
From time to time, we may publicly disclose preliminary, interim or topline data from our clinical trials. These updates are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial.
From time to time, we may publicly disclose preliminary, interim or topline data from our clinical trials. These updates are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or clinical trial.
Additionally, interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Therefore, positive interim results in any ongoing clinical trial may not be predictive of similarly positive results in the completed study or trial.
Additionally, interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Therefore, positive interim results in any ongoing clinical trial may not be predictive of similarly positive results in the completed study or clinical trial.
In addition, any drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may harm our business, financial condition and prospects significantly. Further, clinical trials by their nature utilize a sample of the potential patient population.
In addition, any drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the clinical trial or result in potential product liability claims. Any of these occurrences may harm our business, financial condition and prospects significantly. Further, clinical trials by their nature utilize a sample of the potential patient population.
Identifying and qualifying patients to participate in our clinical trials is critical to our success. We may encounter delays in enrolling, or be unable to enroll, a sufficient number of patients to complete any of our clinical trials, and even once enrolled we may be unable to retain a sufficient number of patients to complete any of our trials.
Identifying and qualifying patients to participate in our clinical trials is critical to our success. We may encounter delays in enrolling, or be unable to enroll, a sufficient number of patients to complete any of our clinical trials, and even once enrolled we may be unable to retain a sufficient number of patients to complete any of our clinical trials.
Factors that may generally affect patient enrollment include: ● the size and nature of the patient population; ● the number and location of clinical sites we enroll; ● competition with other companies for clinical sites or patients; ● the eligibility and exclusion criteria for the trial; ● the design of the clinical trial; ● inability to obtain and maintain patient consents; ● risk that enrolled participants will drop out before completion; and ● competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating.
Factors that may generally affect patient enrollment include: ● the size and nature of the patient population; ● the number and location of clinical sites we enroll; ● competition with other companies for clinical sites or patients; ● the eligibility and exclusion criteria for the clinical trial; ● the design of the clinical trial; ● inability to obtain and maintain patient consents; ● risk that enrolled participants will drop out before completion; and ● competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating.
Further competition could arise from products currently in development, including among others, with GLP1R/GCGR dual agonists, Boehringer Ingelheim, Merck/Hanmi Pharmaceutical, AstraZeneca, Altimmune, Innovent Biologics/Eli Lilly, Carmot and D&D Pharma; with GLP1R/GCGR/GIP triple agonists, Hanmi Pharmaceutical and Eli Lilly; Amgen with its GLP-1R agonist/GIP antagonist antibody; and Novo Nordisk with Amylin and Amylin-GLP-1 combination.
Further competition could arise from products currently in development, including among others, with GLP1R/GCGR dual agonists, from Boehringer Ingelheim, Merck/Hanmi Pharmaceutical, AstraZeneca, Altimmune, Innovent Biologics/Eli Lilly, Carmot and D&D Pharma; with GLP1R/GCGR/GIP triple agonists, from Hanmi Pharmaceutical and Eli Lilly; Amgen with its GLP-1R agonist/GIP antagonist antibody; and Novo Nordisk with Amylin and Amylin-GLP-1 combination.
We, our CROs and our clinical trial sites are required to comply with regulations and current GCP, and comparable foreign requirements to ensure that the health, safety and rights of patients are protected in clinical trials, and that data integrity is assured. Regulatory authorities ensure compliance with GCP requirements through periodic inspections of trial sponsors and trial sites.
We, our CROs and our clinical trial sites are required to comply with regulations and current GCP, and comparable foreign requirements to ensure that the health, safety and rights of patients are protected in clinical trials, and that data integrity is assured. Regulatory authorities ensure compliance with GCP requirements through periodic inspections of clinical trial sponsors and clinical trial sites.
Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured our product candidates and preclinical and clinical drug supplies, including: ● reliance on the third party for regulatory compliance and quality assurance; ● the possibility of breach of the manufacturing agreement by the third party because of factors beyond our control (including a failure to synthesize and manufacture our product candidates or any products that we may eventually commercialize in accordance with our specifications); ● the possibility of termination or nonrenewal of the agreement by the third party, based on our own business priorities, at a time that is costly or damaging to us; ● delay in, or failure to obtain, regulatory approval of any of our product candidates because of the failure by our third-party manufacturer to comply with cGMP or failure to scale up manufacturing processes; and ● current manufacturer and any future manufacturers may not be able to manufacture our product candidates at a cost or in quantities or in a timely manner necessary to make commercially successful products.
Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured our product candidates and preclinical and clinical drug supplies, including: ● reliance on the third party for regulatory compliance and quality assurance; ● the possibility of breach of the manufacturing agreement by the third party because of factors beyond our control (including a failure to synthesize and manufacture our product candidates or any products that we may eventually commercialize in accordance with our specifications); ● the possibility of termination or nonrenewal of the agreement by the third party, based on our own business priorities, at a time that is costly or damaging to us; ● delay in, or failure to obtain, regulatory approval of any of our product candidates because of the failure by our third-party manufacturer to comply with cGMP or failure to scale up manufacturing processes; and ● current manufacturers and any future manufacturers may not be able to manufacture our product candidates at a cost or in quantities or in a timely manner necessary to make commercially successful products.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.
Collaborations involving our product candidates, or any future product candidate pose the following risks to us: ● collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations; ● collaborators may not perform their obligations as expected; ● collaborators may not pursue development and commercialization or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborator’s strategic focus or available funding or external factors such as an acquisition that diverts resources or creates competing priorities; ● collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; ● collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive; ● a collaborator with marketing and distribution rights to one or more product candidates may not commit sufficient resources to the marketing and distribution of any such product candidate; ● collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our proprietary information or expose us to potential litigation; 50 Table of Contents ● collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; ● disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our product candidate or that result in costly litigation or arbitration that diverts management’s attention and resources; ● we may lose certain valuable rights under circumstances identified in our collaborations, including if we undergo a change of control; ● collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; ● collaborators may learn about our discoveries and use this knowledge to compete with us in the future; ● the results of collaborators’ preclinical or clinical studies could harm or impair other development programs; ● there may be conflicts between different collaborators that could negatively affect those collaborations and potentially others; ● the number and type of our collaborations could adversely affect our attractiveness to future collaborators or acquirers; ● collaboration agreements may not lead to the development or commercialization of our product candidate in the most efficient manner or at all.
Collaborations involving our product candidates, or any future product candidate pose the following risks to us: ● collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations; ● collaborators may not perform their obligations as expected; ● collaborators may not pursue development and commercialization or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborator’s strategic focus or available funding or external factors such as an acquisition that diverts resources or creates competing priorities; ● collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; ● collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive; ● a collaborator with marketing and distribution rights to one or more product candidates may not commit sufficient resources to the marketing and distribution of any such product candidate; ● collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our proprietary information or expose us to potential litigation; ● collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; ● disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our product candidate or that result in costly litigation or arbitration that diverts management’s attention and resources; ● we may lose certain valuable rights under circumstances identified in our collaborations, including if we undergo a change of control; 57 Table of Contents ● collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; ● collaborators may learn about our discoveries and use this knowledge to compete with us in the future; ● the results of collaborators’ preclinical or clinical studies could harm or impair other development programs; ● there may be conflicts between different collaborators that could negatively affect those collaborations and potentially others; ● the number and type of our collaborations could adversely affect our attractiveness to future collaborators or acquirers; ● collaboration agreements may not lead to the development or commercialization of our product candidate in the most efficient manner or at all.
Further, DA-1241 and DA-1726 may not receive regulatory approval even if they are successful in clinical trials, or these product candidates may be approved for fewer or more limited indications than we request, such approval may be contingent on the performance of costly post-marketing clinical trials or we may not be allowed to include the labeling claims necessary or desirable for the successful commercialization of such product candidate.
Further, vanoglipel (DA-1241) and DA-1726 may not receive regulatory approval even if they are successful in clinical trials, or these product candidates may be approved for fewer or more limited indications than we request, such approval may be contingent on the performance of costly post-marketing clinical trials or we may not be allowed to include the labeling claims necessary or desirable for the successful commercialization of such product candidate.
Additionally, our R&D efforts are focused, in part, on developing DA-1241 for the treatment of MASH, an indication for which there is only one approved product. The regulatory approval process for novel product candidates, such as DA-1241 for MASH, can be more expensive and take longer than for other, better known or extensively studied product candidates.
Additionally, our R&D efforts are focused, in part, on developing vanoglipel (DA-1241) for the treatment of MASH, an indication for which there is only one approved product. The regulatory approval process for novel product candidates, such as vanoglipel (DA-1241) for MASH, can be more expensive and take longer than for other, better known or extensively studied product candidates.
Clinical trials may be delayed, suspended or terminated for a variety of reasons, such as: ● delay or failure in reaching an agreement with the FDA or a comparable foreign regulatory authority on a trial design that we are able to execute; ● delay or failure in obtaining authorization to commence a trial or inability to comply with conditions imposed by a regulatory authority regarding the scope or design of a clinical trial; ● inability, delay or failure in identifying and maintaining a sufficient number of trial sites, many of which may already be engaged in competing clinical trial programs; ● issues with the manufacture of drug substance for use in clinical trials; ● delay or failure in recruiting and enrolling suitable subjects to participate in a trial; ● delay or failure in having subjects complete a trial or return for post-treatment follow-up; ● clinical sites and investigators deviating from trial protocol, failing to conduct the trial in accordance with regulatory requirements, or dropping out of a trial; ● delay or failure in reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ● delay or failure in obtaining IRB approval to conduct a clinical trial at each site; ● delays resulting from negative or equivocal findings of the Data Safety Monitoring Board (“DSMB”), if any; ● ambiguous or negative results; ● decision by the FDA, a comparable foreign regulatory authority, or recommendation by a DSMB to suspend or terminate clinical trials at any time for safety issues or for any other reason; ● conflicts affecting clinical trial sites and regions where clinical trials are being completed; ● lack of adequate funding to continue the product development program; or ● changes in governmental regulations or requirements.
Clinical trials may be delayed, suspended or terminated for a variety of reasons, such as: ● delay or failure in reaching an agreement with the FDA or a comparable foreign regulatory authority on a clinical trial design that we are able to execute; 44 Table of Contents ● delay or failure in obtaining authorization to commence a clinical trial or inability to comply with conditions imposed by a regulatory authority regarding the scope or design of a clinical trial; ● inability, delay or failure in identifying and maintaining a sufficient number of clinical trial sites, many of which may already be engaged in competing clinical trial programs; ● issues with the manufacture of drug substance for use in clinical trials; ● delay or failure in recruiting and enrolling suitable subjects to participate in a clinical trial; ● delay or failure in having subjects complete a clinical trial or return for post-treatment follow-up; ● clinical sites and investigators deviating from clinical trial protocol, failing to conduct the clinical trial in accordance with regulatory requirements, or dropping out of a clinical trial; ● delay or failure in reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites; ● delay or failure in obtaining IRB approval to conduct a clinical trial at each site; ● delays resulting from negative or equivocal findings of the Data Safety Monitoring Board (“DSMB”), if any; ● ambiguous or negative results; ● a decision by the FDA, a comparable foreign regulatory authority, or recommendation by a DSMB to suspend or terminate clinical trials at any time for safety issues or for any other reason; ● conflicts affecting clinical trial sites and regions where clinical trials are being completed; ● lack of adequate funding to continue the product development program; or ● changes in governmental regulations or requirements.
Although our license agreement with Dong-A includes a number of issued patents that are exclusively licensed to us, the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, issued patents that we own or have licensed from third parties may be challenged in the courts or patent offices in the U.S. and abroad.
Although our license agreement with Dong-A ST includes a number of issued patents that are exclusively licensed to us, the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, issued patents that we own or have licensed from third parties may be challenged in the courts or patent offices in the U.S. and abroad.
If the milestone is reached or the other non-royalty obligations become due, we may not have sufficient funds available to meet our obligations, which may materially adversely affect our business operations and financial condition. 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.
If the milestone is reached or the other non-royalty obligations become due, we may not have sufficient funds available to meet our obligations, which may materially adversely affect our business operations and financial condition. Even if we obtain favorable clinical results, we may not be able to obtain regulatory approval for, or successfully commercialize vanoglipel (DA-1241) and DA-1726.
If the FDA or similar regulatory authorities outside of the U.S. do not approve these other drugs or revoke their approval of, or if safety, efficacy, manufacturing, or supply issues arise with, the drugs we choose to evaluate in combination with DA-1241 and DA-1726 or any other product candidate we develop, we may be unable to obtain approval of or market DA-1241 and DA-1726 or any other product candidate we develop.
If the FDA or similar regulatory authorities outside of the U.S. do not approve these other drugs or revoke their approval of, or if safety, efficacy, manufacturing, or supply issues arise with the drugs we choose to evaluate in combination with vanoglipel (DA-1241) and DA-1726 or any other product candidate we develop, we may be unable to obtain approval of or market vanoglipel (DA-1241) and DA-1726 or any other product candidate we develop.
In addition, pursuant to the Investor Rights Agreement between us and Dong-A, Dong-A has the right to appoint a number of our directors commensurate with its percentage holding of our common stock, which may result in Dong-A controlling both the determinations of the board of directors (“Board”) and the vote of all matters submitted to a vote of our stockholders, which enables them to control all corporate decisions.
In addition, pursuant to the Investor Rights Agreement between Dong-A ST and us, Dong-A ST has the right to appoint a number of our directors commensurate with its percentage holding of our common stock, which may result in Dong-A ST controlling both the determinations of the board of directors (“Board”) and the vote of all matters submitted to a vote of our stockholders, which enables them to control all corporate decisions.
For as long as Dong-A owns shares of our common stock and the Investor Rights Agreement is effective, Dong-A will have significant influence on our management, business plans and policies, including the appointment and removal of members of our Board, decisions on whether to raise future capital and amending our certificate of incorporation and bylaws, which govern the rights attached to our common stock.
For as long as Dong-A ST owns shares of our common stock and the Investor Rights Agreement is effective, Dong-A ST will have significant influence on our management, business plans and policies, including the appointment and removal of members of our Board, decisions on whether to raise future capital and amending our certificate of incorporation and bylaws, which govern the rights attached to our common stock.
In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. We may develop DA-1241 and DA-1726, and potentially future product candidates, in combination with other therapies, which exposes us to additional risks.
In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates. We may develop vanoglipel (DA-1241) and DA-1726, and potentially future product candidates, in combination with other therapies, which exposes us to additional risks.
MASH There is only one approved treatment of MASH, Madrigal Pharmaceuticals’ thyroid hormone receptor beta agonist. However, various therapeutics are used off-label for the treatment of MASH, including vitamin E (an antioxidant), insulin sensitizers (e.g., metformin, pioglitazone), antihyperlipidemic agents (e.g., gemfibrozil), pentoxifylline and ursodeoxycholic acid (UDCA).
MASH There is only one approved treatment of MASH, Madrigal Pharmaceuticals’ thyroid hormone receptor beta agonist. However, various therapeutics are used off-label for the treatment of MASH, including vitamin E (an antioxidant), insulin sensitizers (e.g., metformin, pioglitazone), antihyperlipidemic agents (e.g., gemfibrozil), pentoxifylline and ursodeoxycholic acid.
We have exclusive rights (other than in the Republic of Korea) to DA-1241 and DA-1726 for the specific indications provided in the 2022 License Agreement. Under the 2022 License Agreement, in consideration for the license, we made an upfront payment of 2,200 shares of our Series A Convertible Preferred Stock.
We have exclusive rights (other than in the Republic of Korea) to vanoglipel (DA-1241) and DA-1726 for the specific indications provided in the 2022 License Agreement. Under the 2022 License Agreement, in consideration for the license, we made an upfront payment of 2,200 shares of our Series A Convertible Preferred Stock.
Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control, including difficulties in identifying patients with MASH and significant competition for recruiting such patients in clinical trials.
Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control, including difficulties in identifying patients with MASH or obesity and significant competition for recruiting such patients in clinical trials.
We may engage in strategic transactions that could impact on our liquidity, increase our expenses and present significant distractions to our management. From time to time, we may consider strategic transactions, such as acquisitions of companies, asset purchases and out-licensing or in-licensing of products, drug candidates or technologies.
We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management. From time to time, we may consider strategic transactions, such as acquisitions of companies, asset purchases, in-licensing and out-licensing of products, drug candidates or technologies.
In particular, as a result of the inherent difficulties in diagnosing MASH and the significant competition for recruiting patients with MASH in clinical trials, there may be delays in enrolling the patients we need to complete clinical trials on a timely basis, or at all.
In particular, as a result of the inherent difficulties in diagnosing MASH or obesity and the significant competition for recruiting patients with MASH or obesity in clinical trials, there may be delays in enrolling the patients we need to complete clinical trials on a timely basis, or at all.
Any of these factors, many of which are beyond our control, could jeopardize our ability to obtain regulatory approval for and successfully market DA-1241 and DA-1726. DA-1241 and DA-1726 may not be successful in clinical trials or receive regulatory approval.
Any of these factors, many of which are beyond our control, could jeopardize our ability to obtain regulatory approval for and successfully market vanoglipel (DA-1241) and DA-1726. Vanoglipel (DA-1241) and DA-1726 may not be successful in clinical trials or receive regulatory approval.
If, for example, other banks and financial institutions enter receivership or become insolvent in the future in response to financial conditions affecting the banking system and financial markets, our ability to access our existing cash, cash equivalents and investments may be threatened.
If, for example, banks and financial institutions enter receivership or become insolvent in the future in response to financial conditions affecting the banking system and financial markets, our ability to access our existing cash, cash equivalents and investments may be threatened.
In addition, because our Board is responsible for appointing the members of our management team, these provisions may frustrate or prevent any attempts by stockholders to replace or remove their current management by making it more difficult for stockholders to replace members of our Board.
In addition, because our Board is responsible for appointing the members of our management team, these provisions may frustrate or prevent any attempts by stockholders to replace or remove the current management by making it more difficult for stockholders to replace members of our Board.
In addition to the factors discussed in this “Risk Factors” section, these factors include: ● adverse results or delays in preclinical studies, clinical trials, regulatory decisions or the development status of our product candidates or any product candidates we may pursue in the future; ● our ability to raise sufficient additional funds on satisfactory terms, or at all, necessary for the continued development of our product candidates whether through potential collaborative, partnering or other strategic arrangements or otherwise; ● the terms and timing of any future collaborative, licensing or other strategic arrangements that we may establish; ● our inability to comply with the minimum listing requirements of Nasdaq; ● the timing of achievement of, or failure to achieve, our, or any potential collaborator’s clinical, regulatory and other milestones, such as the commencement of clinical development, the completion of a clinical trial or the receipt of regulatory approval; ● decisions to initiate a clinical trial, not initiate a clinical trial, or terminate an existing clinical trial; ● adverse regulatory decisions, including failure to receive regulatory approval for our product candidates or regulatory actions requiring or leading to a delay or stoppage of any clinical trials; ● the commercial success of any product approved by the FDA or its foreign counterparts; ● changes in applicable laws, rules or regulations; ● adverse developments concerning our manufacturers, suppliers, collaborators and other third parties; ● occurrence of health epidemics or contagious diseases, and potential effects on our business, clinical trial sites, supply chain and manufacturing facilities; ● our failure to commercialize our product candidates; ● the success of competitive drugs; ● if our patents covering our product candidates expire or are invalidated or are found to be unenforceable, or if some or all of our patent applications do not result in issued patents or result in patents with narrow, overbroad, or unenforceable claims; 57 Table of Contents ● additions or departures of key scientific or management personnel; ● unanticipated safety concerns related to the use of any product candidates; ● our announcements or our competitor’s announcements regarding new products, enhancements, significant contracts, acquisitions or strategic partnerships and investments; ● the size and growth of our target markets; ● our, or companies perceived to be similar to us, failure to meet external expectations, or management guidance; ● fluctuations in our quarterly financial results or the quarterly financial results of companies perceived to be similar to us; ● publication of research reports about us or our industry, recommendations, earning results or estimates or withdrawal of research coverage by securities analysts; ● changes in the market valuations of similar companies; ● changes in general economic, industry, political and market conditions due to military conflicts or war, inflation, increases in interest rates, health epidemics, the imposition of tariffs by the U.S. or other countries or trade wars; ● changes in our capital structure or dividend policy, future issuances of securities, sales of common stock by officers, directors and significant stockholders or our incurrence of debt; ● trading volume of our common stock; ● changes in accounting practices and ineffectiveness of our internal controls; ● disputes, litigation or developments relating to proprietary rights; ● timing of milestones and royalty payments; and ● other events or factors, many of which are beyond our control.
In addition to the factors discussed in this “Risk Factors” section, these factors include: ● adverse results or delays in preclinical studies, clinical trials, regulatory decisions or the development status of our product candidates or any product candidates we may pursue in the future; ● our ability to raise sufficient additional funds on satisfactory terms, or at all, necessary for the continued development of our product candidates whether through potential collaborative, partnering or other strategic arrangements or otherwise; ● the terms and timing of any future collaborative, licensing or other strategic arrangements that we may establish; ● our inability to comply with the minimum listing requirements of Nasdaq Capital Market LLC (“Nasdaq”); ● the timing of achievement of, or failure to achieve, our, or any potential collaborator’s clinical, regulatory and other milestones, such as the commencement of clinical development, the completion of a clinical trial or the receipt of regulatory approval; ● decisions to initiate a clinical trial, not initiate a clinical trial, or terminate an existing clinical trial; ● adverse regulatory decisions, including failure to receive regulatory approval for our product candidates or regulatory actions requiring or leading to a delay or stoppage of any clinical trials; ● the commercial success of any product approved by the FDA or its foreign counterparts; ● changes in applicable laws, rules or regulations; ● adverse developments concerning our manufacturers, suppliers, collaborators and other third parties; ● occurrence of health epidemics or contagious diseases, and potential effects on our business, clinical trial sites, supply chain and manufacturing facilities; ● our failure to commercialize our product candidates; ● the success of competitive drugs; ● if our patents covering our product candidates expire or are invalidated or are found to be unenforceable, or if some or all of our patent applications do not result in issued patents or result in patents with narrow, overbroad, or unenforceable claims; ● additions or departures of key scientific or management personnel; ● unanticipated safety concerns related to the use of any product candidates; ● our announcements or our competitor’s announcements regarding new products, enhancements, significant contracts, acquisitions or strategic partnerships and investments; ● the size and growth of our target markets; ● our, or companies perceived to be similar to us, failure to meet external expectations, or management guidance; ● fluctuations in our quarterly financial results or the quarterly financial results of companies perceived to be similar to us; ● publication of research reports about us or our industry, recommendations, earning results or estimates or withdrawal of research coverage by securities analysts; ● changes in the market valuations of similar companies; 64 Table of Contents ● changes in general economic, industry, political and market conditions due to military conflicts or war (including the ongoing conflicts in Ukraine and in the Middle East), inflation, increases in interest rates, health epidemics, the imposition of tariffs by the U.S. or other countries or trade wars; ● changes in our capital structure or dividend policy, future issuances of securities, sales of common stock by officers, directors and significant stockholders or our incurrence of debt; ● trading volume of our common stock; ● changes in accounting practices and ineffectiveness of our internal controls; ● disputes, litigation or developments relating to proprietary rights; ● timing of milestones and royalty payments; and ● other events or factors, many of which are beyond our control.
There are several product candidates in Phase 3 or earlier clinical or preclinical development for the treatment of MASH, including Novo Nordisk’s GLP1 agonist semaglutide, Eli Lilly’s GLP1R and GIP dual agonist tirzepatide, Akero Therapeutics’s FGF21 analog efruxifermin, 89 Bio’s FGF21 analog pegaozafermin, Inventiva’s pan-peroxisome proliferator-activated receptor agonist, Boston Pharmaceuticals and Roche’s fibroblast growth factor 21 analogs, and farnesoid X receptor agonists from Intercept Pharmaceuticals Inc., among others.
There are several product candidates in Phase 3 or earlier clinical or preclinical development for the treatment of MASH, including Novo Nordisk’s GLP1 agonist semaglutide, Eli Lilly’s GLP1R and GIP dual agonist tirzepatide, Akero Therapeutics’ FGF21 analog efruxifermin, 89 Bio’s FGF21 analog pegaozafermin, Inventiva’s pan-peroxisome proliferator-activated receptor agonist, Boston Pharmaceuticals and Roche’s fibroblast growth factor 21 analogs, and farnesoid X receptor agonists from Intercept Pharmaceuticals Inc., among others.
In particular, with a significant ownership percentage of our stock, Dong-A will be able to cause or prevent a change of control of us or a change in the composition of our Board and could preclude any unsolicited acquisition of us.
In particular, with a significant ownership percentage of our stock, Dong-A ST will be able to cause or prevent a change of control of us or a change in the composition of our Board and could preclude any unsolicited acquisition of us.
We will not be able to market and sell DA-1241 and DA-1726 or any product candidate we develop in combination with any such unapproved therapies that do not ultimately obtain marketing approval.
We will not be able to market and sell vanoglipel (DA-1241) and DA-1726 or any product candidate we develop in combination with any such unapproved therapies that do not ultimately obtain marketing approval.
For as long as we continue to be an smaller reporting company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies, including exemption from compliance with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, only being required to provide two years of audited financial statements in our annual reports and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements.
For as long as we continue to be a smaller reporting company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies, including exemption from compliance with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, only being required to provide two years of audited financial statements in our annual reports and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements.
We may engage in future acquisitions, mergers or in-licenses and out-licenses of technology that could disrupt our business, cause dilution to the organization’s stockholders and harm our financial condition and operating results.
We may engage in future acquisitions, mergers, in-licenses and out-licenses of technology that could disrupt our business, cause dilution to the organization’s stockholders and harm our financial condition and operating results.
This concentration of ownership may delay, deter or prevent acts that would be favored by our other stockholders. The interests of Dong-A may not always coincide with our interests or the interests of our other stockholders.
This concentration of ownership may delay, deter or prevent acts that would be favored by our other stockholders. The interests of Dong-A ST may not always coincide with our interests or the interests of our other stockholders.
Nothing in our certificate of incorporation provides that neither Dong-A or any of their affiliates or any director who is not employed by us (including any non-employee director who serves as one of our officers in both her or his director and officer capacities) or its affiliates have any duty to refrain from engaging, directly or indirectly, in the same business activities or similar business activities or lines of business in which we operate.
Nothing in our certificate of incorporation provides that Dong-A ST or any of their affiliates or any director who is not employed by us (including any non-employee director who serves as one of our officers in both her or his director and officer capacities) or its affiliates have any duty to refrain from engaging, directly or indirectly, in the same business activities or similar business activities or lines of business in which we operate.
More restrictive government regulations or negative public opinion could have a material and adverse impact on our business, financial condition, results of operations and prospects, and may delay or impair the development, commercialization (if approved) or demand for DA-1726 or any product candidates we develop. We may be required to make significant payments under the 2022 License Agreement.
More restrictive government regulations or negative public opinion could have a material and adverse impact on our business, financial condition, results of operations and prospects, and may delay or impair the development, commercialization (if approved) or demand for DA-1726, vanoglipel (DA-1241) or any product candidates we develop. We may be required to make significant payments under the 2022 License Agreement.
In addition, later discovery of previously unknown problems with our products, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things: ● restrictions on such products, manufacturers or manufacturing processes; ● restrictions on the labeling, marketing, distribution or use of a product; ● requirements to conduct post-approval clinical trials; ● warning or untitled letters; ● withdrawal of the products from the market; ● refusal to approve pending applications or supplements to approved applications that we submit; ● recall of products; ● fines, restitution or disgorgement of profits or revenue; ● suspension or withdrawal of marketing approvals for the drug products; ● refusal to permit the import or export of our products; 45 Table of Contents ● product seizure; and ● injunctions or the imposition of civil or criminal penalties.
In addition, later discovery of previously unknown problems with our products, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things: ● restrictions on such products, manufacturers or manufacturing processes; ● restrictions on the labeling, marketing, distribution or use of a product; ● requirements to conduct post-approval clinical trials; ● warning or untitled letters; ● withdrawal of the products from the market; ● refusal to approve pending applications or supplements to approved applications that we submit; ● recall of products; ● fines, restitution or disgorgement of profits or revenue; ● suspension or withdrawal of marketing approvals for the drug products; ● refusal to permit the import or export of our products; ● product seizure; and ● injunctions or the imposition of civil or criminal penalties.
For example, these transactions may entail numerous operational and financial risks, including: ● exposure to unknown liabilities; ● disruption of our business and diversion of our management’s time and attention in order to develop acquired products, drug candidates , technologies or businesses ; ● incurrence of substantial debt or dilutive issuances of equity securities to pay for any of these transactions; ● higher-than-expected transaction and integration costs; ● write-downs of assets or goodwill or impairment charges; ● increased amortization expenses; ● difficulty and cost in combining the operations and personnel of any acquired businesses or product lines with our operations and personnel; and ● inability to retain key employees of any acquired business.
For example, these transactions may entail numerous operational and financial risks, including: ● exposure to unknown liabilities; ● disruption of our business and diversion of our management’s time and attention in order to develop acquired products, drug candidates , technologies or businesses ; ● incurrence of substantial debt or dilutive issuances of equity securities to pay for any of these transactions; ● higher-than-expected transaction and integration costs; 49 Table of Contents ● write-downs of assets or goodwill or impairment charges; ● increased amortization expenses; ● difficulty and cost in combining the operations and personnel of any acquired businesses or product lines with our operations and personnel; and ● inability to retain key employees of any acquired business.
Moreover, our success will depend upon physicians and their patients being willing to receive treatments that involve the use of DA-1726 or any product candidates we develop, in lieu of or in addition to, existing treatments that such physicians and their patients are already familiar with and for which greater clinical data may be available.
Moreover, our success will depend upon physicians and their patients being willing to receive treatments that involve the use of DA-1726, vanoglipel (DA-1241) or any product candidates we develop, in lieu of or in addition to, existing treatments that such physicians and their patients are already familiar with and for which greater clinical data may be available.
Further, future acquisitions, mergers or licenses could also pose numerous additional risks to our operations, including: ● problems integrating the purchased or licensed business, products or technologies; ● increases to our expenses; ● the failure to have discovered undisclosed liabilities of the acquired or licensed asset or company; ● diversion of management’s attention from their day-to-day responsibilities; ● harm to our operating results or financial condition; ● entrance into markets in which we have limited or no prior experience; and ● potential loss of key employees, particularly those of the acquired entity.
Further, future acquisitions, mergers or licenses could also pose numerous additional risks to our operations, including: ● problems integrating the purchased or licensed business, products or technologies; ● increases to our expenses; ● the failure to have discovered undisclosed liabilities of the acquired or licensed asset or company; ● diversion of management’s attention from their day-to-day responsibilities; 56 Table of Contents ● harm to our operating results or financial condition; ● entrance into markets in which we have limited or no prior experience; and ● potential loss of key employees, particularly those of the acquired entity.
Management’s Discussion and Analysis of Financial Condition and Results of Operations. 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 relinquish rights to our technologies.
Management’s Discussion and Analysis of Financial Condition and Results of Operations. As we do not 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 relinquish rights to our technologies.
In the ordinary course of its business activities, Dong-A and its affiliates may engage in activities where their interests conflict with our interests or those of our other stockholders, such as investing in or advising businesses that directly or indirectly compete with certain portions of our business or are suppliers or customers of ours.
In the ordinary course of its business activities, Dong-A ST, Dong-A Holdings and their affiliates may engage in activities where their interests conflict with our interests or those of our other stockholders, such as investing in or advising businesses that directly or indirectly compete with certain portions of our business or are suppliers or customers of ours.
We may develop DA-1241 and DA-1726 and future product candidates in combination with one or more currently approved therapies.
We may develop vanoglipel (DA-1241) and DA-1726 and future product candidates in combination with one or more currently approved therapies.
We have no experience manufacturing our product candidates on a large clinical or commercial scale and have no manufacturing facility. We currently have no plans to build our own clinical or commercial scale manufacturing capabilities. We currently work exclusively with Dong-A as the sole manufacturer for the production of DA-1241 and DA-1726.
We have no experience manufacturing our product candidates on a large clinical or commercial scale and have no manufacturing facility. We currently have no plans to build our own clinical or commercial scale manufacturing capabilities. We currently work exclusively with Dong-A ST as the sole manufacturer for the production of vanoglipel (DA-1241) and DA-1726.
Because we have limited financial and managerial resources, we focus on research programs and product candidates that we identify for specific indications. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential.
Because we have limited financial and managerial resources, we focus on research programs and product candidates that we identify for specific indications. As a result, we may forgo or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential.
We are and expect to continue to be dependent on collaborations with partners relating to the development and commercialization of our existing and future research programs and product candidates. In particular, we rely on Dong-A to provide services with respect to our development of DA-1241 and DA-1726.
We are and expect to continue to be dependent on collaborations with partners relating to the development and commercialization of our existing and future research programs and product candidates. In particular, we rely on Dong-A ST to provide services with respect to our development of vanoglipel (DA-1241) and DA-1726.
Market acceptance of any of our product candidates for which we receive regulatory approval depends on a number of factors, including: ● the clinical indications for which the product candidate is approved; ● acceptance by major operators of hospitals, physicians and patients of the product candidate as a safe and effective treatment, particularly the ability of our product candidates to establish themselves as a new standard of care in the treatment paradigm for the indications that we are pursuing; ● the potential and perceived advantages of our product candidates over alternative treatments as compared to the relative costs of the product candidates and alternative treatments; ● the willingness of physicians to prescribe, and patients to take, a product candidate that is based on a botanical source; ● the prevalence and severity of any side effects with respect to our product candidates, and any elements that may be imposed by the FDA under a REMS program that could discourage market uptake of the products; ● the availability of adequate reimbursement and pricing for any approved products by third party payors and government authorities; ● inability of certain types of patients to take our product; ● demonstrated ability to treat patients and, if required by any applicable regulatory authority in connection with the approval for target indications, to provide patients with incremental cardiovascular disease benefits, as compared with other available therapies; ● the relative convenience and ease of administration of our product candidates, including as compared with other treatments available for approved indications; ● limitations or warnings contained in the labeling approved by the FDA; ● availability of alternative treatments already approved or expected to be commercially launched in the near future; ● the effectiveness of our sales and marketing strategies; ● guidelines and recommendations of organizations involved in research, treatment and prevention of various diseases that may advocate for alternative therapies; ● the willingness of patients to pay out-of-pocket in the absence of third-party coverage; ● physicians or patients may be reluctant to switch from existing therapies even if potentially more effective, safe or convenient; ● efficacy, safety, and potential advantages compared to alternative treatments; ● the ability to offer our product for sale at competitive prices; 41 Table of Contents ● the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; ● any restrictions on the use of our product together with other medications; ● interactions of our product with other medicines patients are taking; and ● the timing of market introduction of our products as well as competitive products.
Even if we obtain regulatory approval for any of our product candidates that we may develop or acquire in the future, the product may not gain market acceptance among hospitals, physicians, health care payors, patients, and the medical community. 47 Table of Contents Market acceptance of any of our product candidates for which we receive regulatory approval depends on a number of factors, including: ● the clinical indications for which the product candidate is approved; ● acceptance by major operators of hospitals, physicians and patients of the product candidate as a safe and effective treatment, particularly the ability of our product candidates to establish themselves as a new standard of care in the treatment paradigm for the indications that we are pursuing; ● the potential and perceived advantages of our product candidates over alternative treatments as compared to the relative costs of the product candidates and alternative treatments; ● the willingness of physicians to prescribe, and patients to take, a product candidate that is based on a botanical source; ● the prevalence and severity of any side effects with respect to our product candidates, and any elements that may be imposed by the FDA under a REMS program that could discourage market uptake of the products; ● the availability of adequate reimbursement and pricing for any approved products by third party payors and government authorities; ● inability of certain types of patients to take our product; ● demonstrated ability to treat patients and, if required by any applicable regulatory authority in connection with the approval for target indications, to provide patients with incremental cardiovascular disease benefits, as compared with other available therapies; ● the relative convenience and ease of administration of our product candidates, including as compared with other treatments available for approved indications; ● limitations or warnings contained in the labeling approved by the FDA; ● availability of alternative treatments already approved or expected to be commercially launched in the near future; ● the effectiveness of our sales and marketing strategies; ● guidelines and recommendations of organizations involved in research, treatment and prevention of various diseases that may advocate for alternative therapies; ● the willingness of patients to pay out-of-pocket in the absence of third-party coverage; ● physicians or patients may be reluctant to switch from existing therapies even if potentially more effective, safe or convenient; ● efficacy, safety, and potential advantages compared to alternative treatments; ● the ability to offer our product for sale at competitive prices; ● the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; ● any restrictions on the use of our product together with other medications; ● interactions of our product with other medicines patients are taking; and ● the timing of market introduction of our products as well as competitive products.
For example, severe adverse events observed with GLP-1 receptor agonists include, but are not limited to, acute pancreatitis, acute gallbladder disease, acute kidney injury and worsening of diabetic retinopathy. Such side effects associated with GLP-1 receptor or GLP-1/GIP receptor targeting treatments may negatively impact public perception of us, DA-1726 or any product candidates we develop.
For example, severe AEs observed with GLP-1 receptor agonists include, but are not limited to, acute pancreatitis, acute gallbladder disease, acute kidney injury and worsening of diabetic retinopathy. Such side effects associated with GLP-1 receptor or GLP-1/GIP receptor targeting treatments may negatively impact public perception of us, DA-1726 or any product candidates we develop.
We are a “smaller reporting company” and we cannot be certain if the reduced reporting requirements applicable to such companies could make our common stock less attractive to investors. We are a “smaller reporting company”, as defined in the Exchange Act.
We are a “smaller reporting company” and we cannot be certain if the reduced reporting requirements applicable to such companies could make our common stock less attractive to investors. We are a “smaller reporting company,” as defined in the Exchange Act.
Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates. 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 could result in material changes in the final data.
Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates. 42 Table of Contents 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 could result in material changes in the final data.
Before making your decision to invest in shares of our common stock, you should carefully consider the risks described below, together with the other information contained in this Annual 31 Table of Contents Report, including in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in our consolidated financial statements and the related notes included elsewhere in this Annual Report.
Before making your decision to invest in shares of our common stock, you should carefully consider the risks described below, together with the other information contained in this Annual Report, including in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in our consolidated financial statements and the related notes included elsewhere in this Annual Report.
Factors that may inhibit our efforts to commercialize our product candidates on our own include: ● our inability to recruit and retain adequate numbers of effective sales and marketing personnel; ● the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future pharmaceutical products; and ● unforeseen costs and expenses associated with creating an independent sales and marketing organization.
Factors that may inhibit our efforts to commercialize our product candidates on our own include: ● our inability to recruit and retain adequate numbers of effective sales and marketing personnel; ● the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future pharmaceutical products; and 51 Table of Contents ● unforeseen costs and expenses associated with creating an independent sales and marketing organization.
To meet our projected needs for clinical supplies to support our activities for DA-1241 and DA-1726 through regulatory approval and commercial manufacturing, Dong-A will need to provide sufficient scale of production for these projected needs.
To meet our projected needs for clinical supplies to support our activities for vanoglipel (DA-1241) and DA-1726 through regulatory approval and commercial manufacturing, Dong-A ST will need to provide sufficient scale of production for these projected needs.
Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future 33 Table of Contents lead to market-wide liquidity problems.
Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems.
Negative public reaction to treatments for obesity and overweight patients in general could result in greater government regulation and stricter labeling requirements of products to treat these chronic conditions, including DA-1726, if approved, and could cause a decrease in the demand for DA-1726 or any product candidates we may develop.
Negative public reaction to treatments for obesity, overweight patients, MASH and MASH patients in general could result in greater government regulation and stricter labeling requirements of products to treat these chronic conditions, including DA-1726 and vanoglipel (DA-1241), if approved, and could cause a decrease in the demand for DA-1726, vanoglipel (DA-1241) or any product candidates we may develop.
Our inability to enroll a sufficient 39 Table of Contents number of patients for our clinical trials would result in significant delays, which would increase our costs and have an adverse effect on our Company. We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
Our inability to enroll a sufficient number of patients for our clinical trials would result in significant delays, which would increase our costs and have an adverse effect on our Company. We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
To the extent any of our product candidates are approved for obesity, the commercial success of our product will also depend on our ability to demonstrate benefits over the then-prevailing standard of care. Finally, morbidly obese 40 Table of Contents patients sometimes undergo a gastric bypass procedure, with salutary effects on the many co-morbid conditions of obesity.
To the extent any of our product candidates are approved for obesity, the commercial success of our product will also depend on our ability to demonstrate benefits over the then-prevailing standard of care. Finally, morbidly obese patients sometimes undergo a gastric bypass procedure, with salutary effects on the many co-morbid conditions of obesity.
If we, any of our CROs or our clinical trial sites fail to comply with applicable GCP requirements, the clinical data generated in our clinical trials, or a specific site may be deemed 48 Table of Contents unreliable, and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications.
If we, any of our CROs or our clinical trial sites fail to comply with applicable GCP requirements, the clinical data generated in our clinical trials, or a specific site may be deemed unreliable, and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications.
In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock and negatively impact our ability to raise additional funds.
In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive 60 Table of Contents these results to be negative, it could have a substantial adverse effect on the price of our common stock and negatively impact our ability to raise additional funds.
In the future, we may choose to build a focused sales and marketing infrastructure to sell some of our product candidates if and when they are approved. 44 Table of Contents There are risks involved both with establishing our own sales and marketing capabilities and with entering into arrangements with third parties to perform these services.
In the future, we may choose to build a focused sales and marketing infrastructure to sell some of our product candidates if and when they are approved. There are risks involved both with establishing our own sales and marketing capabilities and with entering into arrangements with third parties to perform these services.
If we are unable to raise additional funds through equity or debt financing or other 32 Table of Contents arrangements when needed, we may be required to delay, scale back or discontinue the development and commercialization of one or more of our product candidates or delay our pursuit of potential in-licenses, out-licenses or acquisitions.
If we are unable to raise additional funds through equity or debt financing or other arrangements when needed, we may be required to delay, scale back or discontinue the development and commercialization of one or more of our product candidates or delay our pursuit of potential in-licenses, out-licenses or acquisitions.
In addition, if any significant adverse events or other side effects are observed in any of our future clinical trials, it may make it more difficult for us to recruit patients to our clinical trials and patients may drop out of our trials, or we may be required to abandon the trials or our development efforts of one or more product candidates altogether.
In addition, if any significant AEs or other side effects are observed in any of our future clinical trials, it may make it more difficult for us to recruit patients to our clinical trials and patients may drop out of our clinical trials, or we may be required to abandon the clinical trials or our development efforts of one or more product candidates altogether.
We do not have any insurance for liabilities arising from medical or hazardous materials. Although we maintain workers’ compensation insurance to cover us for costs and expenses, we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities.
We do not have any insurance for liabilities arising from medical or hazardous materials. Although we maintain workers’ compensation insurance to cover us for costs and expenses, we may incur costs due to injuries to our employees resulting from the use of 50 Table of Contents hazardous materials, and this insurance may not provide adequate coverage against potential liabilities.
The competition for qualified personnel in the pharmaceutical field is intense and as a result, we may be unable to continue to attract and retain qualified personnel necessary for the development of our business or to recruit suitable replacement personnel. 55 Table of Contents We may need to increase the size of our organization, and we may experience difficulties in managing this growth.
The competition for qualified personnel in the pharmaceutical field is intense and as a result, we may be unable to continue to attract and retain qualified personnel necessary for the development of our business or to recruit suitable replacement personnel. We may need to increase the size of our organization, and we may experience difficulties in managing this growth.
If there is no active market for our common stock, it may be difficult for our stockholders to sell shares without depressing the market price for the shares or at all. If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our business, the price of our stock could decline.
If there is no active market for our common stock, it may be difficult for our stockholders to sell shares without depressing the market price for the shares or at all. 67 Table of Contents If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our business, the price of our stock could decline.
This could result in our own products being removed from the market or being less successful commercially. 38 Table of Contents We may also evaluate DA-1241 and DA-1726 or any other future product candidates in combination with one or more other therapies that have not yet been approved for marketing by the FDA or similar regulatory authorities outside of the U.S.
This could result in our own products being removed from the market or being less successful commercially. We may also evaluate vanoglipel (DA-1241) and DA-1726 or any other future product candidates in combination with one or more other therapies that have not yet been approved for marketing by the FDA or similar regulatory authorities outside of the U.S.
Moreover, any drug compounds we recommend for clinical development may not demonstrate, through preclinical studies, indications of safety and potential efficacy that would support advancement into clinical trials. Such findings would potentially 37 Table of Contents impede our ability to maintain or expand our clinical development pipeline.
Moreover, any drug compounds we recommend for clinical development may not demonstrate, through preclinical studies, indications of safety and potential efficacy that would support advancement into clinical trials. Such findings would potentially impede our ability to maintain or expand our clinical development pipeline.
As a condition to submitting an NDA to the FDA for DA-1241 or DA-1726, we must successfully complete several clinical trials demonstrating efficacy and safety.
As a condition to submitting a NDA to the FDA for vanoglipel (DA-1241) or DA-1726, we must successfully complete several clinical trials demonstrating efficacy and safety.
The impact of the Tax Act and any future tax reform on holders of our common stock is likewise uncertain and could be adverse. We are also subject to regular reviews, examinations, and audits by the IRS and other taxing authorities with respect to our taxes.
The impact of these tax acts and any future tax reform on holders of our common stock is likewise uncertain and could be adverse. We are also subject to regular reviews, examinations, and audits by the IRS and other taxing authorities with respect to our taxes.
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could impair our ability to compete in the marketplace. Competitors may infringe or otherwise violate our intellectual property, including patents that may be issued to or be licensed by us.
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could impair our ability to compete in the marketplace. 59 Table of Contents Competitors may infringe or otherwise violate our intellectual property, including patents that may be issued to or be licensed by us.
To the extent that any disruption or security breach was to result in a loss of, or damage to, our data or applications, 60 Table of Contents or inappropriate disclosure of confidential or proprietary information, we could incur liability, and the further development and commercialization of our product candidates could be delayed.
To the extent that any disruption or security breach was to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability, and the further development and commercialization of our product candidates could be delayed.
However, these rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is 61 Table of Contents provided by regulatory and governing bodies.
However, these rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies.
As a result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed. We rely on third parties to manufacture our product candidates and preclinical and clinical drug supplies.
As a result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed. 55 Table of Contents We rely on third parties to manufacture our product candidates and preclinical and clinical drug supplies.
Our ability to identify new drug compounds and advance them into clinical development also depends upon our ability to fund our research and development operations, and we cannot be certain that additional funding will be available on acceptable terms, or at all.
Our ability to identify new drug compounds and advance them into clinical development also depends upon our ability to fund our R&D operations, and we cannot be certain that additional funding will be available on acceptable terms, or at all.
For as long as we continue to be an smaller reporting company, we may take advantage of exemptions from various reporting requirements, including exemption from compliance with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley Act”), only being required to provide two years of audited financial statements in our annual reports and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements.
For as long as we continue to be a smaller reporting company, we may take advantage of exemptions from various reporting requirements, including exemption from compliance with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley Act”), only being 66 Table of Contents required to provide two years of audited financial statements in our annual reports and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements.
If we or our licensors fail to maintain the patents and patent applications covering our product candidates, our competitors might be able to enter the market, which would have a material adverse effect on our business. Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
If we or our licensors fail to maintain the 61 Table of Contents patents and patent applications covering our product candidates, our competitors might be able to enter the market, which would have a material adverse effect on our business. Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
Future growth would impose significant added responsibilities on our employees, including: ● managing our clinical trials effectively; ● identifying, recruiting, maintaining, motivating and integrating additional employees; ● managing our internal development efforts effectively while complying with our contractual obligations to licensors, contractors and other third parties; and ● improving our managerial, development, operational and finance systems.
Future growth would impose significant added responsibilities on our employees, including: 62 Table of Contents ● managing our clinical trials effectively; ● identifying, recruiting, maintaining, motivating and integrating additional employees; ● managing our internal development efforts effectively while complying with our contractual obligations to licensors, contractors and other third parties; and ● improving our managerial, development, operational and finance systems.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeFurthermore, significant cybersecurity matters, and strategic 63 Table of Contents risk management decisions are escalated to the Board, ensuring that they have comprehensive oversight and can provide guidance on critical cybersecurity issues. ​
Biggest changeOur Chief Financial Officer is informed by our third-party monitoring service of any cybersecurity incidents, who will then escalate the incident to our Chief Executive Officer, if necessary. Furthermore, significant cybersecurity matters, and strategic risk management decisions are escalated to the Board, ensuring that they have comprehensive oversight and can provide guidance on critical cybersecurity issues. ​
The audit committee is composed of board members with diverse expertise including risk management, technology, and finance, equipping them to oversee cybersecurity risks effectively. Our Chief Executive Officer, Chief Financial Officer and corporate controller have operational experience in assessing and managing cybersecurity risk. Our Chief Executive Officer plays a pivotal role in informing the audit committee on cybersecurity risks.
The audit committee is composed of Board members with diverse expertise including risk management, technology, and finance, equipping them to oversee cybersecurity risks effectively. Our Chief Executive Officer, Chief Financial Officer and corporate controller have operational experience in assessing and managing cybersecurity risk.
They provide comprehensive briefings to the audit committee on a regular basis, with a minimum frequency of once per year.
Our Chief Executive Officer plays a pivotal role in informing the audit committee on 69 Table of Contents cybersecurity risks. They provide comprehensive briefings to the audit committee on a regular basis, with a minimum frequency of once per year.
Removed
Our Chief Financial Officer is informed by our third-party monitoring service of any cybersecurity incidents, who will then escalate the incident to our Chief Executive Officer, if necessary.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeItem 2. Properties We currently lease 2,441 square feet of office space in Cambridge, Massachusetts, as our corporate headquarters. The initial lease term is for three years with an option to renew for an additional two-year term. The lease commenced in September 2023 and expires in August 2026.
Biggest changeItem 2. Properties We currently lease 2,441 square feet of office space in Cambridge, Massachusetts, as our corporate headquarters. The initial lease term is for three years with an option, which was exercised in November 2025, to renew for an additional two-year term. The lease commenced in September 2023 and expires in August 2028.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeAny future determination to pay dividends on our common stock will be, subject to applicable law, at the discretion of our Board and will depend upon, among other factors, our results of operations, financial condition, capital requirements, and contractual restrictions in loan or other agreements.
Biggest changeAny future determination to pay dividends on our common stock will be, subject to applicable law, at the discretion of our Board and will depend upon, among other factors, our results of operations, financial condition, capital requirements, and contractual restrictions in loan or other agreements. 70 Table of Contents Recent sales of unregistered securities; use of proceeds from registered offerings During the year ended December 31, 2025, we did not issue or sell any unregistered securities not previously disclosed in a Quarterly Report on Form 10-Q or in a Current Report on Form 8-K.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market information Our common stock is listed on Nasdaq under the symbol “MTVA.” Stockholders On March 17, 2025, we had 8,654,869 shares of common stock outstanding and 52 holders of record of our common stock.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market information Our common stock is listed on Nasdaq under the symbol “MTVA.” Stockholders On March 20, 2026, we had 5,090,936 shares of common stock outstanding and 26 holders of record of our common stock.
Removed
Recent sales of unregistered securities; use of proceeds from registered offerings During the year ended December 31, 2024, we did not issue or sell any unregistered securities not previously disclosed in a Quarterly Report on Form 10-Q or in a Current Report on Form 8-K.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

50 edited+36 added−13 removed26 unchanged
Biggest changeFinancing activities currently represent the principal source of our cash flow. 69 Table of Contents The following table reflects the major categories of cash flows for each of the periods presented (in thousands). ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2024 ​ 2023 Net cash used in operating activities ​ $ (24,710) ​ $ (10,799) Net cash used in investing activities ​ (8) ​ ​ (50) Net cash provided by (used in) financing activities ​ 18,300 ​ ​ (80) Net decrease in cash ​ $ (6,418) ​ $ (10,929) Net cash used in operating activities was $24.7 million for 2024 and consisted of net loss of $27.6 million, partially offset by net cash provided by change in operating assets and liabilities of $2.6 million and non-cash charges totaling $0.3 million, which was primarily related to stock-based compensation and change in fair value of warrant liabilities.
Biggest changeThe following table reflects the major categories of cash flows for each of the periods presented (in thousands). ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ ​ ​ 2025 ​ 2024 Net cash used in operating activities ​ $ (15,701) ​ $ (24,710) Net cash used in investing activities ​ (2) ​ ​ (8) Net cash provided by financing activities ​ 9,964 ​ ​ 18,300 Net decrease in cash ​ $ (5,739) ​ $ (6,418) Net cash used in operating activities was $15.7 million for 2025 and consisted of net loss of $13.0 million and net cash used by change in operating assets and liabilities of $2.9 million, partially offset by adjustments for non-cash charges totaling $0.2 million, which was primarily attributable to $0.4 million of stock-based compensation costs and $0.2 million gain from change in fair value of warrant liabilities.
We expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we: ● pursue clinical development for our current product candidates; ● initiate preclinical studies and clinical trials with respect to our current product candidates and indications and any future product candidates or indications that we may pursue; ● acquire or in-license other product candidates and/or technologies; ● develop, maintain, expand and protect our intellectual property portfolio; ● hire additional clinical, scientific and commercial personnel; ● establish a commercial manufacturing source and secure supply chain capacity sufficient to provide commercial quantities of any product candidates for which we may obtain regulatory approval; ● seek regulatory approvals for any product candidates that successfully complete clinical trials; 67 Table of Contents ● establish a sales, marketing and distribution infrastructure and/or enter into partnership arrangements to commercialize any products for which we may obtain regulatory approval; or ● add administrative, operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts, and to support being a public reporting company.
We expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we: ● pursue clinical development for our current product candidates; ● initiate preclinical studies and clinical trials with respect to our current product candidates and indications and any future product candidates or indications that we may pursue; 74 Table of Contents ● acquire or in-license other product candidates and/or technologies; ● develop, maintain, expand and protect our intellectual property portfolio; ● hire additional clinical, scientific and commercial personnel; ● establish a commercial manufacturing source and secure supply chain capacity sufficient to provide commercial quantities of any product candidates for which we may obtain regulatory approval; ● seek regulatory approvals for any product candidates that successfully complete clinical trials; ● establish a sales, marketing and distribution infrastructure and/or enter into partnership arrangements to commercialize any products for which we may obtain regulatory approval; or ● add administrative, operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts, and to support being a public reporting company.
While we primarily focus our financial resources and management’s attention on the development of DA-1241 and DA-1726, we also have four legacy therapeutic programs designed to impact a range of indications in viral, neurodegenerative and cardiometabolic diseases, which we are not planning to advance development on and have, or continue to consider for, out-licensing and divestiture opportunities.
While we focus our financial resources and management’s attention on the development of vanoglipel (DA-1241) and DA-1726, we also have four legacy therapeutic programs designed to impact a range of indications in viral, neurodegenerative and cardiometabolic diseases, which we are not planning to advance development on and have, or continue to consider for, out-licensing and divestiture opportunities.
Commitments and contingencies" to the consolidated financial statements included in this Annual Report. In the ordinary course of business, we enter into agreements with third parties that include indemnification provisions, which, in our judgment, are normal and customary for companies in our industry sector. These agreements are typically with business partners, clinical sites, and suppliers.
Commitments and contingencies” to the consolidated financial statements included in this Annual Report. In the ordinary course of business, we enter into agreements with third parties that include indemnification provisions, which, in our judgment, are normal and customary for companies in our industry sector. These agreements are typically with business partners, clinical sites, and suppliers.
Accordingly, we have no liabilities recorded for these provisions as of December 31, 2024 and 2023. In the normal course of business, we may be confronted with issues or events that may result in contingent liability. These generally relate to lawsuits, claims, environmental actions, or the actions of various regulatory agencies.
Accordingly, we have no liabilities recorded for these provisions as of December 31, 2025 and 2024. In the normal course of business, we may be confronted with issues or events that may result in contingent liability. These generally relate to lawsuits, claims, environmental actions, or the actions of various regulatory agencies.
For additional details, see the consolidated statements of cash flows in the consolidated financial statements included elsewhere in this Annual Report. Contractual obligations, purchase commitments and employment agreements Contractual obligations We entered into a non-cancelable operating lease for our corporate headquarters in Cambridge, Massachusetts. For additional i nformation, see "Note 6.
For additional details, see the consolidated statements of cash flows in the consolidated financial statements included elsewhere in this Annual Report. Contractual obligations, purchase commitments and employment agreements Contractual obligations We entered into a non-cancelable operating lease for our corporate headquarters in Cambridge, Massachusetts. For additional i nformation, see “Note 6.
Our cash forecast for the 12-month period from the filing date of this Annual Report utilizes current cash balance less estimated payments for future clinical trials and G&A costs plus forecasted cash inflows. Our estimates and judgements used in clinical trial costs and accruals are described below.
Our cash forecast for the 12-month period from the filing date of this Annual Report utilizes current cash balance less estimated payments for future clinical trials and G&A costs plus forecasted cash inflows. Our estimates and judgments used in clinical trial costs and accruals are described below.
Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We have some control over the timing of these expenses, but costs may be difficult to control once clinical trials have commenced.
Product candidates in later stages of clinical development generally have higher development costs than those in preclinical development or in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We have some control over the timing of these expenses, but costs may be difficult to control once clinical trials have commenced.
Our critical accounting estimates and judgements relate to the following items: (i) cash forecast for conclusion about MetaVia’s ability to continue as a going concern, (ii) conclusion on the classification of warrants based on the underlying warrant and transaction agreements, and (iii) clinical trial costs and accruals.
Our critical accounting estimates and judgments relate to the following items: (i) cash forecast for conclusion about MetaVia’s ability to continue as a going concern, (ii) conclusion on the classification of warrants based on the underlying warrant and transaction agreements, and (iii) clinical trial costs and accruals.
We will continue to monitor all positive and negative evidence until we believe it is more likely than not that the valuation allowance is no longer necessary, resulting in an income tax benefit in the period such determination is made. We have U.S. federal NOL carryforwards and U.S. federal R&D credit carryforwards, and these carryforwards will not expire.
We will continue to monitor all positive and negative evidence until we believe it is more likely than not that the valuation allowance is no longer necessary, resulting in an income tax benefit in the period such determination is made. We have U.S. federal NOL carryforwards, and these carryforwards will not expire.
DA-1241 has demonstrated beneficial effects on glucose, lipid profile and liver inflammation, as demonstrated during in-vivo preclinical studies. ● DA-1726 is a novel oxyntomodulin analogue functioning as a GLP1R and GCGR dual agonist for the treatment of obesity that is designed to be administered once weekly subcutaneously.
Vanoglipel (DA-1241) has demonstrated beneficial effects on glucose, lipid profile and liver inflammation, as demonstrated during in-vivo preclinical studies. ● DA-1726 is a novel oxyntomodulin analog functioning as a GLP1R and GCGR dual agonist for the treatment of obesity that is designed to be administered once weekly subcutaneously.
If we are unable to raise additional capital, we may slow down or stop our ongoing and planned clinical trials until such time as additional capital is raised and this may have a material adverse effect on us.
If we are unable to raise additional capital, we may slow down or stop our ongoing and planned clinical trials until such time as additional capital is raised and this may have a material adverse effect on the Company.
Additionally, because of the risks inherent in novel treatment discovery and development, we cannot reasonably estimate or know: ● the timing and progress of preclinical and clinical development activities; ● the number and scope of clinical programs that we decide to pursue; ● our ability to maintain our current development programs and to establish new ones; ● establishing an appropriate safety profile with IND-enabling studies; ● successful patient enrollment in, and the initiation and completion of, clinical trials; ● the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority; ● the receipt of regulatory approvals from applicable regulatory authorities; ● the timing, receipt and terms of any marketing approvals from applicable regulatory authorities; ● our ability to establish new licensing or collaboration arrangements; ● establishing agreements with third-party manufacturers for clinical supply for our clinical trials and commercial manufacturing, if any of our product candidates is approved; ● development and timely delivery of clinical-grade and commercial-grade drug formulations that can be used in our clinical trials and for commercial launch; ● obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights; ● launching commercial sales of our product candidates, if approved, whether alone or in collaboration with others; ● maintaining a continued acceptable safety profile of the product candidates following commercialization; or ● the effect of competing technological and market developments. 66 Table of Contents A change in the outcome of any of these variables with respect to the development of our product candidates could significantly change the costs and timing associated with the development of that product candidate.
Additionally, because of the risks inherent in novel treatment discovery and development, we cannot reasonably estimate or know: ● the timing and progress of preclinical and clinical development activities; ● the number and scope of preclinical and clinical programs that we decide to pursue; ● our ability to maintain our current development programs and to establish new ones; ● establishing an appropriate safety profile with IND-enabling studies; ● successful patient enrollment in, and the initiation and completion of, clinical trials; 73 Table of Contents ● the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority; ● the receipt of regulatory approvals from applicable regulatory authorities; ● the timing, receipt and terms of any marketing approvals from applicable regulatory authorities; ● our ability to establish new licensing or collaboration arrangements; ● establishing agreements with third-party manufacturers for clinical supply for our clinical trials and commercial manufacturing, if any of our product candidates is approved; ● development and timely delivery of clinical-grade and commercial-grade drug formulations that can be used in our clinical trials and for commercial launch; ● obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights; ● launching commercial sales of our product candidates, if approved, whether alone or in collaboration with others; ● maintaining a continued acceptable safety profile of the product candidates following commercialization; or ● the effect of competing technological and market developments.
Accrual for research and development costs related to clinical trial activities As part of the process of preparing our consolidated financial statements, we are required to record an accrual for R&D costs related to clinical trial activities.
Accrual for R&D costs related to clinical trial activities As part of the process of preparing our consolidated financial statements, we are required to record an accrual for R&D costs related to clinical trial activities.
This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf, and estimating the level of service provided and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs.
This process involves reviewing contracts and purchase orders, communicating with our clinical research staff to identify services that have been performed on our behalf, and estimating the level of service provided and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs.
In July 2024, we entered into an exclusive out-license agreement with MThera to provide MThera with the rights to NB-01 for the treatment of painful diabetic neuropathy. Our operations have consisted principally of performing R&D activities, which include preclinical developments and clinical trials, and raising capital.
In 2024, we entered into an exclusive out-license agreement with MThera to provide MThera with the rights to one of our legacy therapeutic program, NB-01, for the treatment of painful diabetic neuropathy. Our operations consisted principally of performing R&D activities, which include preclinical development and clinical trials, and raising capital.
We use our employee and infrastructure resources across multiple research and development projects. We do not allocate employee costs and costs associated with our facilities, including depreciation or other indirect costs, to specific product candidates because these costs are deployed across multiple programs and, as such, are not separately classified. We use internal resources to manage CMO and CRO activities.
We do not allocate employee costs and costs associated with our facilities, including depreciation or other indirect costs, to specific product candidates because these costs are deployed across multiple programs and, as such, are not separately classified. We utilize internal resources to manage CRO and CMO activities. These employees work across multiple programs.
These employees work across multiple programs. We do not track our costs by product candidate. Clinical development activities are central to our business model. We do not believe that our historical costs are indicative of the future costs associated with these programs, nor do they represent the costs of other future programs we may initiate.
Clinical development activities are central to our business model. We do not believe that our historical costs are indicative of the future costs associated with these programs, nor do they represent the costs of future programs we may initiate.
Our direct research and development expenses consist primarily of external costs, such as fees paid to outside consultants, CROs, CMOs and research laboratories in connection with our clinical development, quality assurance and quality control processes, manufacturing, and clinical development activities. Our direct research and development expenses also include fees incurred under third-party license agreements.
Our direct R&D expenses consist primarily of external costs, such as fees paid to CROs, CMOs, research laboratories and outside consultants in connection with our clinical development, quality assurance and quality control processes, manufacturing, and clinical development activities.
Going concern As reflected in the consolidated financial statements, we had $16.0 million in cash as of December 31, 2024. We have experienced net losses and negative cash flows from operating activities since our inception and had an accumulated deficit of $135.9 million as of December 31, 2024.
Going concern As reflected in the consolidated financial statements, we had $10.3 million in cash and cash equivalents as of December 31, 2025. We have experienced net losses and negative cash flows from operating activities since our inception and had an accumulated deficit of $148.8 million as of December 31, 2025.
As of the date hereof, we do not expect to achieve such milestones in the near term, but we would have to obtain additional capital to pay such milestone payments. Additional information regarding contingent payments and license agreements is in “Note 5. Related party” and "Note 6. Commitments and contingencies" to the consolidated financial statements included in this Annual Report.
As of the date hereof, we do not expect to achieve such milestones in the near term, but we would have to obtain additional capital to pay such milestone payments. 78 Table of Contents Additional information regarding contingent payments and license agreements is in “Note 5. Related party” and “Note 6.
Purchase commitments Information regarding purchase commitments is in "Note 6. Commitments and contingencies" to the consolidated financial statements included in this Annual Report. 70 Table of Contents Employment agreements Information regarding employment agreements is in "Note 6. Commitments and contingencies" to the consolidated financial statements included in this Annual Report.
Commitments and contingencies” to the consolidated financial statements included in this Annual Report. Purchase commitments Information regarding purchase commitments is in “Note 6. Commitments and contingencies” to the consolidated financial statements included in this Annual Report. Employment agreements Information regarding employment agreements is in “Note 6. Commitments and contingencies” to the consolidated financial statements included in this Annual Report.
These conditions raise substantial doubt about our ability to continue as a going concern within one year from the issuance of our consolidated financial statements in Part II, Item 8. F inancial Statements and Supplementary Data . We believe that our existing cash will be sufficient to fund our operations into the third quarter of 2025.
These conditions raise substantial doubt about our ability to continue as a going concern within one year from the issuance of our consolidated financial statements in Part II, Item 8. Financial Statements and Supplementary Data.
See “Special Note Regarding Forward-Looking Statements.” Our actual results may differ materially from those contained in or implied by any forward-looking statements as a result of various factors, including, but not limited to, the risks and uncertainties described under “Risk Factors” elsewhere in this Annual Report. 64 Table of Contents Certain amounts in the following discussion and analysis may not add due to rounding, and all percentages have been calculated using unrounded amounts.
This discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties. See “Special Note Regarding Forward-Looking Statements.” Our actual results may differ materially from those contained in or implied by any forward-looking statements as a result of various factors, including, but not limited to, the risks and uncertainties described under “Risk Factors” elsewhere in this Annual Report.
These expenses include: ● employee-related expenses, including salaries, related benefits and stock-based compensation, for employees engaged in research and development functions; ● expenses incurred in connection with the clinical development of our product candidates, including under agreements with third parties, such as consultants and CROs; ● the cost of manufacturing and storing drug products for use in our preclinical studies and clinical trials, including under agreements with third parties, such as consultants and Clinical Manufacturing Organizations (“CMOs”); ● facilities, depreciation and other expenses, which include direct or allocated expenses for rent and maintenance of facilities and insurance; ● costs related to compliance with regulatory requirements; and 65 Table of Contents ● payments made under third-party licensing agreements.
These expenses include: 72 Table of Contents Direct costs ● expenses incurred in connection with the clinical development of our product candidates, including under agreements with third parties, such as CROs and consultants; ● the cost of manufacturing and storing drug products for use in our preclinical studies and clinical trials, including under agreements with third parties, such as consultants and Clinical Manufacturing Organizations (“CMOs”); ● costs related to compliance with regulatory requirements; and ● payments made under third-party licensing agreements including the Shared Services Agreement with Dong-A ST (related party).
Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period.
Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. 79 Table of Contents Recent accounting pronouncements Information regarding (i) adoption of new accounting standards during 2025 and (ii) accounting standards issued but not yet adopted is included in “Note 1.
Such amounts are recognized as an expense when the goods have been delivered or the services have been performed, or when it is no longer expected that the goods will be delivered, or the services rendered.
Nonrefundable advance payments for goods or services to be received in the future for use in R&D activities are recorded as prepaid expenses. Such amounts are recognized as an expense when the goods have been delivered or the services have been performed, or when it is no longer expected that the goods will be delivered, or the services rendered.
This basis of accounting contemplates the recovery of our assets and the satisfaction of our liabilities in the normal course of business. Liquidity and capital resources Our primary use of cash is to fund our R&D activities. We have funded our operations primarily through public offerings of our common stock and private placements of equity and convertible securities.
This basis of accounting contemplates the recovery of our assets and the satisfaction of our liabilities in the normal course of business. 76 Table of Contents Liquidity and capital resources Our primary use of cash is to fund our R&D activities.
Results of Operations 2024 compared to 2023 The following table summarizes our results of operations for 2024 and 2023 (in thousands, other than 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 ​ $ (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 Operating expenses and loss from operations Our total operating expenses and loss from operations for 2024 were $28.8 million, an increase of $12.9 million, or 81.3%, compared to 2023.
Results of Operations 2025 compared to 2024 The following table summarizes our results of operations for 2025 and 2024 (in thousands, except share and per share amounts): ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ ​ ​ 2025 ​ 2024 Operating expenses: ​ ​ ​ ​ ​ ​ Research and development ​ $ 6,802 ​ $ 21,553 General and administrative ​ ​ 6,906 ​ ​ 7,256 Total operating expenses ​ 13,708 ​ 28,809 Loss from operations ​ (13,708) ​ (28,809) Other income: ​ ​ ​ ​ ​ ​ Gain from change in fair value of warrant liabilities ​ ​ 225 ​ ​ 297 Interest income, net ​ ​ 510 ​ ​ 920 Total other income ​ ​ 735 ​ ​ 1,217 Loss before income taxes ​ ​ (12,973) ​ ​ (27,592) Provision for income taxes ​ ​ — ​ ​ — Net loss ​ $ (12,973) ​ $ (27,592) Loss per share of common stock, basic and diluted ​ $ (7.35) ​ $ (39.13) Weighted average shares of common stock, basic and diluted ​ 1,766,026 ​ 705,193 Operating expenses and loss from operations Our total operating expenses and loss from operations for 2025 were $13.7 million, a decrease of $15.1 million, or 52.4%, compared to 2024.
Net cash used in investing activities, related to the purchases of property equipment, was less than $0.1 million for 2024 and 2023. Net cash provided by financing activities was $18.3 million for 2024 compared to net cash used in financing activities of less than $0.1 million for 2023.
Net cash used in investing activities, related to the purchases of property equipment, was less than $0.1 million for 2025 and 2024. Net cash provided by financing activities was $10.0 million for 2025, which primarily consisted of proceeds of $10.0 million from the 2025 private placement offering and $1.2 million from the ATM Program.
Net cash used in operating activities was $10.8 million for 2023 and consisted of net loss of $12.5 million and non-cash credits totaling $2.8 million, which was primarily related to change in fair value of warrant liabilities, partially offset by net cash provided by changes in operating assets and liabilities of $4.4 million.
Net cash used in operating activities was $24.7 million for 2024 and consisted of net loss of $27.6 million, partially offset by net cash provided by change in operating assets and liabilities of $2.6 million and non-cash charges totaling $0.3 million, which was primarily attributable to $0.5 million of stock-based compensation and $0.2 million gain from change in fair value of warrant liabilities.
This increase was primarily attributable to $1.0 million in higher employee compensation and benefits, partially offset by (i) $0.4 million in lower consulting expenditures, and (ii) $0.1 million in lower legal and professional fees. Other income Our other income for 2024 was $1.2 million, a decrease of $2.2 million, or 64.4%, compared to 2023.
This decrease in G&A expenses was primarily attributable to $0.7 million in lower consulting expenditures, $0.1 million in lower insurance, and $0.2 million in lower other G&A expenses. These decreases were partially offset by $0.5 million in higher legal and professional fees and $0.1 million in higher employee compensation and benefits.
This increase was attributable to higher R&D and G&A expenses. Our R&D expenses were $21.6 million for 2024, an increase of $12.4 million, or 135.3%, compared to 2023.
This decrease was attributable to lower R&D and G&A expenses for 2025. Our R&D expenses were $6.8 million for 2025, a decrease of $14.8 million, or 68.4%, compared to 2024. Our G&A expenses were $6.9 million for 2025, a decrease of $0.4 million, or 4.8%, compared to 2024.
This decrease was attributable to $2.7 million in lower gain related to the change in fair value of warrant liabilities due to warrant exercises in 2023 and the impact of our common stock’s declining stock price during the last few years, partially offset by $0.5 million in higher interest income due primarily to higher average invested amount in 2024.
This decrease was attributable to $0.4 million in lower interest income, net, due to lower balances of cash and cash equivalents and lower interest rates, and $0.1 million in lower gain from the change in fair value of warrant liabilities due to the impact of our common stock’s volatile stock price during the last few years.
Due in large part to the ongoing Phase 2a clinical trial for DA-1241 and Phase 1 clinical trial for DA-1726, we expect to continue to incur net losses and negative cash flows from operating activities for the foreseeable future.
We have incurred a net loss of $13.0 million and net cash used in operating activities of $15.7 million for 2025. Due in large part to ongoing clinical trials, we expect to continue to incur net losses and negative cash flows from operating activities for the foreseeable future.
Our ability to generate product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more of our current or future product candidates.
We also have state NOL carryforwards, and these carryforwards will begin to expire in 2042, if not utilized. Net loss We have incurred significant operating losses since our inception. Our ability to generate product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more of our current or future product candidates.
Net cash provided by financing activities for 2024 primarily consisted of gross proceeds from the Offering of $20.0 million, net of payment of issuance cost of $1.7 million. Net cash used in financing activities of less than $0.1 million for 2023 was attributable to payment of financing costs related to a prior financing transaction in 2022.
Net cash provided by financing activities was $18.3 million for 2024, which primarily consisted of proceeds of $20.0 million from the 2024 private placement offering, partially offset by the payment of $1.7 million of issuance costs in connection with the 2024 private placement offering.
We plan to continue to fund our operations from equity offerings, debt financing, or other sources, potentially including collaborations, out-licensing and other similar arrangements. However, there can be no assurance that we will be able to obtain any sources of financing on acceptable terms, or at all, or that the Series A Warrants will be exercised.
However, there can be no assurance that we will be able to obtain any sources of financing on acceptable terms, or at all, or that the warrants issued in previously consummated offerings will be exercised.
As of December 31, 2024, we had cash totaling $16.0 million. We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $0.25 million per bank.
We have funded our operations primarily through public offerings of our common stock and private placements of equity and convertible securities. As of December 31, 2025, we had cash totaling $10.3 million. We maintain cash at financial institution that at times may exceed the Federal Deposit Insurance Corporation insured limits of $0.25 million per bank.
Overview We are a clinical-stage biotechnology company focused primarily on developing novel pharmaceuticals to treat cardiometabolic diseases. MetaVia has two programs focused primarily on the treatment of MASH and obesity. ● DA-1241 is a novel GPR119 agonist with development optionality as a standalone and/or combination therapy for both MASH and T2DM.
We have two programs focused primarily on the treatment of MASH and obesity. ● Vanoglipel (DA-1241) is a novel GPR119 agonist with development optionality as a standalone or combination therapy for both MASH and T2DM. Agonism of GPR119 in the gut promotes the release of key gut peptides, GLP-1, GIP and PYY.
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.
These peptides play a further role in glucose metabolism, lipid metabolism and weight loss.
Recent accounting pronouncements Information regarding (i) adoption of new accounting standards during 2024 and (ii) accounting standards issued but not yet adopted is included in “Note 1. Business, basis of presentation, new accounting standards and summary of significant accounting policies” to the consolidated financial statements included in this Annual Report. 71 Table of Contents ​
Business, basis of presentation, new accounting standards and summary of significant accounting policies” to the consolidated financial statements included in this Annual Report. ​
Provision for income taxes Our effective tax rate for 2024 and 2023 was zero percent as we have recorded a full valuation allowance for the income tax benefits attributable to our pre-tax losses. 68 Table of Contents Net loss For 2024, we had a net loss of $27.6 million, or $3.56 per share of basic and diluted common stock, compared to a net loss of $12.5 million, or $2.46 per share of basic and diluted common stock for 2023.
Provision for income taxes Our effective tax rate for 2025 and 2024 was zero percent as we have recorded a full valuation allowance for the income tax benefits attributable to our pre-tax losses.
We recognize external development costs based on an evaluation of the progress toward completion of specific tasks using information provided to us by our service providers.
Indirect costs ● employee-related expenses, including salaries, related benefits and stock-based compensation, for employees engaged in R&D functions; and ● consulting and other expenses not directly tied to a product candidate. We recognize external development costs based on an evaluation of the progress toward completion of specific tasks using information provided to us by our service providers.
The offering of the shares was made pursuant to our effective shelf registration statement on Form S-3 (Registration No. 333-278646), initially filed with and declared effective by the SEC in April 2024, and a prospectus supplement filed with the SEC in June 2024.
The offer and sale of the shares of common stock pursuant to the ATM Program is made pursuant to a shelf registration statement on Form S-3 and the related prospectus (File No. 333-278646) filed with the SEC on April 12, 2024, and declared effective by the SEC on April 23, 2024, as supplemented by a prospectus supplement to be filed with the SEC on November 6, 2025 pursuant to Rule 424(b) under the Securities Act.
For additional information, see “Note 7. Stockholders’ equity” to the consolidated financial statements included elsewhere in this Report. Cash Flows The principal use of cash in operating activities is to fund our current expenditures in support of our R&D activities and clinical development activities.
For additional information, see “Note 7. Stockholders’ equity” to the consolidated financial statements included elsewhere in this Annual Report.
K ey operating information Research and development expenses R&D expenses consist primarily of costs incurred in connection with the development of our product candidates.
Additionally, since the common stock par value was unchanged, the amounts for common stock and additional paid-in capital have been adjusted to give effect to the Reverse Stock Split for all periods presented. K ey operating information R&D expenses R&D expenses consist primarily of costs incurred in connection with the development of our product candidates.
Royalties owed on future sales of any licensed product will be expensed in the period the related revenues are recognized. General and administrative expenses G&A expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel in executive, finance and administrative functions.
A change in the outcome of any of these variables with respect to the development of our product candidates could significantly change the costs and timing associated with the development of that product candidate. G&A expenses G&A expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel in executive, finance and administrative functions.
Specifically, the increase in R&D expenses was primarily attributable to (i) $9.3 million in higher clinical trial expenditures, (ii) $2.5 million in higher expenditures for investigational drug manufacturing, non-clinical and preclinical costs related to expenses incurred under the Shared Services Agreement with Dong-A, and (iii) $1.2 million in higher employee compensation and benefits.
Included in direct R&D costs were expenses totaling $3.4 million and $4.9 million for 2025 and 2024, respectively, related to investigational drug manufacturing, non-clinical and preclinical costs incurred under the Shared Services Agreement with Dong-A ST (related party). Our G&A expenses were $6.9 million for 2025, a decrease of $0.4 million, or 4.8%, compared to 2024.
The Private Placement was comprised of (i) 2,544,530 shares of common stock, (ii) pre-funded warrants to purchase up to 1,781,171 shares of common stock (the “Pre-Funded Warrants”), (iii) Series A warrants to purchase 5,089,060 shares of common stock (the “Series A Warrants”), and (iv) Series B warrants to purchase up to 7,633,591 shares of common stock (the “Series B Warrants”).
The private placement offering was comprised of (i) 861,758 shares of our common stock for a purchase price of $7.81 per share and (ii) 418,651 pre-funded warrants to purchase up to an equivalent number of shares of our common stock for a purchase price of $7.799 per pre-funded warrant.
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This discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties.
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Certain amounts in the following discussion and analysis may not add due to rounding, and all percentages have been calculated using unrounded amounts. Overview We are a clinical-stage biotechnology company focused primarily on developing novel pharmaceuticals to treat cardiometabolic diseases.
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Recent developments ● December 2024: Announced positive top-line 16-week results from the two-part Phase 2a clinical trial in patients with presumed MASH. ● November 2024 : Announced a strategic realignment, ahead of important clinical milestones, with a corporate name change to MetaVia Inc. ● November 2024: Announced completion of last patient last visit for Phase 2a clinical trial evaluating DA-1241 for the treatment of MASH. ● September 2024: Announced positive top-line data from the SAD Part 1 of our Phase 1 clinical trial evaluating DA-1726 for the treatment of obesity.
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Recent developments ● November 2025: Presented new Phase 1 and pre-clinical data on DA-1726 in two poster presentations at ObesityWeek ® 2025. The Phase 1 data demonstrated favorable safety and tolerability, a newly characterized 32 mg PK profile supporting once-weekly dosing, and meaningful reductions in body weight and waist circumference following four weeks of treatment.
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Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses.
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Additionally, in a DIO mouse model, DA-1726 achieved comparable weight loss to pemvidutide with superior lipid-lowering efficacy. ● November 2025: Presented positive new data from our Phase 2a clinical trial evaluating vanoglipel (DA-1241), and the data highlights vanoglipel’s differentiated dual activity across both hepatic and metabolic pathways, demonstrating clinically meaningful improvements in glucose control, liver health, and plasma lipidomic profiles following 16 weeks of treatment. 71 Table of Contents ● January 202 6 : Announced positive statistically significant results from the 8-week (extended from four weeks) non-titrated 48 mg, MAD cohort of our Phase 1 clinical trial of DA-1726, and the results show robust early weight loss, statistically significant reductions in waist circumference, strong improvements in glucose control, and meaningful reductions in liver stiffness, alongside a favorable safety and tolerability profile. ● January 2026: Closed an underwritten public offering of shares of common stock, pre-funded warrants, Series C Common Warrants and Series D Common Warrants for gross proceeds of approximately $9.3 million, prior to deducting underwriting discounts and commissions and offering expenses and excluding any potential future proceeds from the exercise of warrants. ● February 2026: Announced positive AI-modeling results from the ongoing collaboration with Syntekabio, Inc., an AI-driven drug discovery company, leveraging their proprietary DeepMatcher® platform.
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Acquired in-process research and development expenses We include costs to acquire or in-license product candidates in-process research and development (“IPR&D”).
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The results confirmed vanoglipel’s strong inflammatory and cardiometabolic target engagement, supporting development in MASH and, potentially, type 2 diabetes. ● February 2026: Strengthened global intellectual property position for DA-1726 with 39 granted and pending patents in the U.S. and internationally, providing protection at least through 2041, unless extended further.
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When we acquire the right to develop and commercialize a new product candidate, any up-front payments, or any future milestone payments that relate to the acquisition or licensing of such a right are immediately expensed as acquired in-process research and development in the period in which they are incurred.
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Exclusively licensed from Dong-A ST Co., Ltd., the portfolio broadly covers DA-1726’s novel peptide structure, its long-acting dual-incretin design, and therapeutic use across obesity, metabolic disease, and related cardiometabolic conditions. ● March 2026: Announced a comprehensive global intellectual property portfolio supporting vanoglipel with 48 granted and pending patents across three patent families in the U.S., Europe, Japan, China and other countries, providing protection into 2035, unless extended further.
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These costs are immediately expensed provided that the payments do not also represent processes or activities that would constitute a “business,” or provided that the product candidate has not achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative future use.
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Exclusively licensed from Dong-A ST Co., Ltd., the patent portfolio provides broad protection for vanoglipel itself, how it is manufactured, and its potential use across a range of serious metabolic and liver conditions. ● March 2026: Received IRB approval from Clinical Pharmacology of Miami for the Phase 1 Part 3 16-week titration study of DA-1726, enabling higher-dose evaluation in obese, otherwise healthy adults.
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We also have state NOL carryforwards and state R&D credit carryforwards. Our state NOL and R&D credit carryforwards will begin to expire in 2042, if not utilized. Net loss We have incurred significant operating losses since our inception.
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Common stock reverse stock split In December 2025, we completed a one-for-eleven reverse stock split of our common stock (the “Reverse Stock Split”). As a result, every eleven shares of our issued and outstanding common stock were combined, converted and changed into one share of our common stock.
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This increase was primarily related to increased R&D activities related to Phase 2a clinical trial for DA-1241 and Phase 1 trial for DA-1726 for 2024 as compared to 2023 when R&D activities began to ramp up following the acquisition of DA-1241 and DA-1726 in the fourth quarter of 2022.
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Any fraction of a share of our common stock that was created as a result of the Reverse Stock Split was rounded down to the next whole share and the stockholder received cash equal to the market value of the fractional share, determined by multiplying such fraction by the closing sales price of our common stock as reported on Nasdaq on the last trading day before the Reverse Stock Split.
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These increases were partially offset by (i) $0.2 million in lower consulting expenditures and (ii) $0.4 million in lower other R&D costs. Our G&A expenses were $7.3 million for 2024, an increase of $0.5 million, or 7.8%, compared to 2023.
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The Reverse Stock Split was approved by our stockholders at the annual meeting of stockholders in June 2025.
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We have incurred a net loss of $27.6 million and net cash used in operating activities of $24.7 million for the year ended December 31, 2024.
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At the annual meeting, the stockholders approved a proposal to amend our certificate of incorporation to affect a reverse split of our outstanding common stock at a ratio in the range of one-for-five to one-for-thirty to be determined at the discretion of our Board. In November 2025, our Board approved the Reverse Stock Split.
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Our cash balance includes liquid insured deposits, which are obligations of the banks in which the deposits are held and qualify for FDIC insurance protection per depositor in each recognized legal category of account ownership in accordance with the rules of the FDIC. To date, we have not experienced any losses related to these funds.
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The Reverse Stock Split did not impact the number of authorized shares of common stock, which remains at 100,000,000 shares.
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Registered direct offering and private placement In June 2024, we closed on a registered direct offering of 763,359 shares of common stock at a purchase price of $3.93 per share for gross proceeds of $3.0 million (the “Registered Direct Offering”) with an institutional investor.
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For the Reverse Stock Split, a proportionate adjustment was made to the per share exercise price and the number of shares issuable upon the exercise of all outstanding stock options and warrants to purchase shares of our common stock, the number of shares issuable upon vesting of restricted stock units (“RSUs”) and the number of shares reserved for issuance pursuant to our equity incentive compensation plans.
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In June 2024, we closed on a private placement offering (the “Private Placement,” and together with the Registered Direct Offering, the “Offering”) with an institutional investor and Dong-A, and received aggregate gross proceeds of $17.0 million, of which $10.0 million was received from Dong-A.
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In this Annual Report, including the accompanying consolidated financial statements and the notes to the consolidated financial statements, the number of shares of common stock and per share data have been adjusted to give effect to the Reverse Stock Split for all periods presented.
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Our direct R&D expenses also include fees incurred under third-party license agreements, including the Shared Services Agreement with Dong-A ST (related party) . We utilize our employee and infrastructure resources across multiple R&D projects.
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Our direct R&D expenses consist of (i) expenses attributable to our product candidates and (ii) certain other R&D expenses, including clinical, non-clinical and preclinical services or other R&D expenses that are not attributable to a single product candidate. Our indirect R&D expenses consist of (i) employment-related expenses for compensation and benefits, which are internal costs and (ii) consulting expenses.
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The following table summarizes our R&D expenses for 2025 and 2024 (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ ​ ​ ​ ​ ​ 2025 ​ 2024 ​ ​ ​ Change Direct costs ​ ​ ​ ​ ​ ​ ​ ​ ​ Vanoglipel (DA-1241) (credits) costs ​ $ (845) ​ $ 9,959 ​ $ (10,804) DA-1726 costs ​ ​ 5,468 ​ ​ 9,397 ​ ​ (3,929) Other R&D costs ​ ​ 107 ​ ​ 303 ​ ​ (196) Indirect costs ​ ​ ​ ​ ​ ​ ​ ​ ​ Employee compensation and benefits costs ​ ​ 1,653 ​ ​ 1,606 ​ ​ 47 Consulting expenses ​ ​ 419 ​ ​ 288 ​ ​ 131 Total research and development ​ $ 6,802 ​ $ 21,553 ​ ​ (14,751) 75 Table of Contents The $14.8 million decrease in R&D expenses reflects decreased R&D activities related to the Phase 2a clinical trial for vanoglipel (DA-1241) and decreased activities related to the Phase 1 clinical trial for DA-1726 as compared to 2024.
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Specifically, the decrease in R&D expenses was primarily attributable to (i) $10.8 million in lower direct R&D expenses related to vanoglipel (DA-1241) product development, (ii) $3.9 million in lower direct R&D expenses related to DA-1726 product development, and (iii) $0.2 million in lower direct other R&D costs.

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