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What changed in MetaVia Inc.'s 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of MetaVia Inc.'s 2023 and 2024 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 2024 report.

+448 added−446 removedSource: 10-K (2025-03-20) vs 10-K (2024-03-28)

Top changes in MetaVia Inc.'s 2024 10-K

448 paragraphs added · 446 removed · 322 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

125 edited+31 added−20 removed209 unchanged
Biggest changeThis is the first-in-human MASH trial for DA-1241 and we are expecting top line results by the end of 2024 . ● 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 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 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.
Mergers and acquisitions in the pharmaceutical, biotechnology and diagnostic industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors with us, particularly through collaborative arrangements with large and established companies.
Mergers and acquisitions in the pharmaceutical, biotechnology and diagnostic industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors with us, particularly through collaborative arrangements with large established companies.
If a compound demonstrates evidence of effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 trials are undertaken to obtain the 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 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.
The centralized procedure is compulsory for human drugs that are: (i) 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) officially designated "orphan drugs" (drugs used for rare human diseases) and (iv) 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.
Accelerated evaluation might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of a 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: the seriousness of the disease to be treated, the absence of an appropriate alternative therapeutic approach, and anticipation of exceptional high therapeutic benefit.
In this circumstance, the EMA ensures that the evaluation for the opinion of the CHMP is completed within 150 days and the opinion issued thereafter.
In this circumstance, the EMA ensures that the evaluation for the opinion of the CHMP is completed within 150 days and the opinion is issued thereafter.
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 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.
The therapeutic potential of DA-1241 has been demonstrated in multiple preclinical animal models of MASH and T2DM where DA-1241 reduced hepatic steatosis, inflammation, fibrosis, and improved glucose control. o In Phase 1a and 1b human trials, DA-1241 was well tolerated in both healthy volunteers and those with T2DM. o We initiated a Phase 2a trial in 2023 with the goal of establishing the mechanism of action and efficacy of DA-1241 in the treatment of MASH and to evaluate trends for T2DM.
The therapeutic potential of DA-1241 has been demonstrated in multiple preclinical animal models of MASH and T2DM where DA-1241 reduced hepatic steatosis, inflammation, fibrosis, and improved glucose control. o In Phase 1a and 1b human trials, DA-1241 was well tolerated in both healthy volunteers and those with T2DM. o We initiated a Phase 2a clinical trial in 2023 with the goal of establishing the mechanism of action and efficacy of DA-1241 in the treatment of MASH and to evaluate trends for T2DM.
The overall ten-year period will be extended to a maximum of eleven years if, during the first eight years of those ten years, the marketing authorization (“MA”) holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.
The overall ten-year period will be extended to a maximum of eleven years if, during the first eight years of those ten years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.
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; 28 ​ Table of Contents ● 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; ● 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.
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-1 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, 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.
FDA Regulation In the U.S., pharmaceutical products are subject to extensive 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.
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.
Some of the laws that may affect our future ability to operate include: ● the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs; ● federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent; ● the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; ● HIPAA, as amended by the Health Information Technology and Clinical Health Act (“HITECH”) and its implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information; ● the federal transparency requirements under the Physician Payments Sunshine Act require manufacturers of FDA-approved drugs, devices, biologics and medical supplies covered by Medicare or Medicaid to report, on an annual basis, to the Department of Health and Human Services information related to payments and other transfers of value to physicians, teaching hospitals, and certain advanced non-physician health care practitioners and physician ownership and investment interests; and ● state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
Some of the laws that may affect our future ability to operate include: ● the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs; 26 Table of Contents ● federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent; ● the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; ● HIPAA, as amended by the Health Information Technology and Clinical Health Act and its implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information; ● the federal transparency requirements under the Physician Payments Sunshine Act require manufacturers of FDA-approved drugs, devices, biologics and medical supplies covered by Medicare or Medicaid to report, on an annual basis, to the Department of Health and Human Services information related to payments and other transfers of value to physicians, teaching hospitals, and certain advanced non-physician health care practitioners and physician ownership and investment interests; and ● state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
DA-1241 improved hepatic inflammation and fibrosis, showing a decrease in MASLD activity score (“NAS”) 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.
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.
Exploratory endpoints will include the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference and body mass index (“BMI”), among others. Other Product Candidates We are focusing our financial resources and management’s attention on the development of DA-1241 for MASH and DA-1726 for obesity.
Exploratory endpoints will include the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference and body mass index, among others. Other Product Candidates We are focusing our financial resources and management’s attention on the development of DA-1241 for MASH and DA-1726 for obesity.
This application is similar to the NDA in the U.S., with the exception of, among other things, country-specific document requirements. All application procedures require an application in the common technical document (“CTD”) format, which includes the submission of detailed information about the manufacturing and quality of the product, and non-clinical and clinical trial information.
This application is similar to the NDA in the U.S., with the exception of, among other things, country-specific document requirements. All application procedures require an application in the common technical document format, which includes the submission of detailed information about the manufacturing and quality of the product, and non-clinical and clinical trial information.
The European Commission created the centralized procedure for the approval of human drugs to facilitate marketing authorizations that are valid throughout the European Union and, by extension (after national implementing decisions) in Iceland, Liechtenstein and Norway, which, together with European Union member states, comprise the European Economic Area (“EEA”).
The European Commission created the centralized procedure for the approval of human drugs to facilitate marketing authorizations that are valid throughout the European Union and, by extension (after national implementing decisions) in Iceland, Liechtenstein and Norway, which, together with European Union member states, comprise the European Economic Area.
We will 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 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 believe ANA001 has the potential to reduce the viral load and inflammation associated with cytokine dysregulation, acute respiratory distress syndrome (“ARDS”), and coagulation abnormalities and thus improve time to clinical improvement as defined as hospital discharge recorded using the WHO Ordinal Scale for Clinical Improvement.
We believe ANA001 has the potential to reduce the viral load and inflammation associated with cytokine dysregulation, acute respiratory distress syndrome, and coagulation abnormalities and thus improve time to clinical improvement as defined as hospital discharge recorded using the WHO Ordinal Scale for Clinical Improvement.
The requirements and process governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country, even though there is already some degree of legal harmonization in the European Union member states resulting from the national implementation of underlying European Union. legislation.
The requirements and process governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country, even though there is some degree of legal harmonization in the European Union member states resulting from the national implementation of the underlying European Union. legislation.
As described further below, the FDA strictly regulates marketing, labeling, advertising and promotion of prescription drug products that are placed on the market. Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label.
As described below, the FDA strictly regulates marketing, labeling, advertising and promotion of prescription drug products that are placed on the market. Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved label.
Additionally, the Fast Track designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process. In 2012, Congress enacted the Food and Drug Administration Safety and Innovation Act (“FDASIA”).
Additionally, the Fast Track designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process. In 2012, Congress enacted the Food and Drug Administration Safety and Innovation Act.
There can be no assurance that any of our pending patent applications will be issued or that we will benefit from any patent term extension or other favorable adjustment to the term of any patents. 16 ​ Table of Contents As with other biotechnology and pharmaceutical companies, our ability to maintain and solidify our proprietary and intellectual property position for our product candidates, preclinical compounds, and core technologies will depend on our success in obtaining effective patent claims and enforcing those claims if granted.
There can be no assurance that any of our pending patent applications will be issued or that we will benefit from any patent term extension or other favorable adjustment to the term of any patents. 18 Table of Contents As with other biotechnology and pharmaceutical companies, our ability to maintain and solidify our proprietary and intellectual property position for our product candidates, preclinical compounds, and core technologies will depend on our success in obtaining effective patent claims and enforcing those claims if granted.
The centralized procedure may, at the voluntary request of the applicant, also be used for human drugs which do not fall within the above-mentioned categories if the CHMP agrees that (a) the human drug contains a new active substance not yet approved on November 20, 2005; (b) it constitutes a significant therapeutic, scientific or technical innovation or (c) authorization under the centralized procedure is in the interests of patients at the European Union level.
The centralized procedure may, at the voluntary request of the applicant, also be used for human drugs which do not fall within the above-mentioned categories if the CHMP agrees that (a) the human drug contains a new active substance not yet approved as of November 20, 2005; (b) it constitutes a significant therapeutic, scientific or technical innovation or (c) authorization under the centralized procedure is in the interests of patients at the European Union level.
In high-fat diet-induced obese (“HF-DIO”) mice, DA-1726 showed more body weight loss and increasing energy expenditure than a pair-fed group. 11 ​ Table of Contents Mean energy expenditure: DA-1726* # 16.6 kcal/kg/hr Pair-Fed 12.4 kcal/kg/hr HF Control 12.6 kcal/kg/hr Mechanism of action In comparison with GLP-1 analogue, DA-1726 represented superior body weight loss compared to semaglutide in HF-DIO obese mice.
In high-fat diet-induced obese (“HF-DIO”) mice, DA-1726 showed more body weight loss and increasing energy expenditure than a pair-fed group. 13 Table of Contents Mean energy expenditure: DA-1726* # 16.6 kcal/kg/hr Pair-Fed 12.4 kcal/kg/hr HF Control 12.6 kcal/kg/hr Mechanism of action In comparison with GLP-1 analogue, DA-1726 represented superior body weight loss compared to semaglutide in HF-DIO obese mice.
The conduct of the nonclinical tests must comply with federal requirements, including the FDA's good laboratory practice regulations and the regulations of the U.S. Department of Agriculture (“USDA”) implementing the Animal Welfare Act.
The conduct of the nonclinical tests must comply with federal requirements, including the FDA's good laboratory practice regulations and the regulations of the U.S. Department of Agriculture implementing the Animal Welfare Act.
For those medicinal products for which the centralized procedure is not available, the applicant must submit marketing authorization applications to the national medicines regulators through one of three procedures: (i) the mutual recognition procedure (which must be used if the product has already been authorized in at least one other European Union member state, and in which the European Union member states are required to grant an authorization recognizing the existing authorization 26 ​ Table of Contents in the other European Union member state, unless they identify a serious risk to public health), (ii) the decentralized procedure (in which applications are submitted simultaneously in two or more European Union member states) or (iii) national authorization procedures (which results in a marketing authorization in a single European Union member state).
For those medicinal products for which the centralized procedure is not available, the applicant must submit marketing authorization applications to the national medicines regulators through one of three procedures: (i) the mutual recognition procedure (which must be used if the product has already been authorized in at least one other European Union member state, and in which the European Union member states are required to grant an authorization recognizing the existing authorization in the other European Union member state, unless they identify a serious risk to public health), (ii) the decentralized procedure (in which applications are submitted simultaneously in two or more European Union member states) or (iii) national authorization procedures (which results in a marketing authorization in a single European Union member state).
The safety and toxicology studies completed were: (i) central nervous system (“CNS”), cardiovascular (“CV”), and respiratory safety in rats and dogs; (ii) a single-dose, 4-week, 13-week and 26-week oral toxicity studies in rats; (iii) 4-week, 13-week and 39-week oral toxicity studies in dogs; (iv) pre-natal development studies in rats and rabbits; and (v) genotoxicity tests of in vitro bacterial reverse mutation, chromosome aberration, and in vivo micronucleus.
The safety and toxicology studies completed were: (i) central nervous system, cardiovascular, and respiratory safety in rats and dogs; (ii) a single-dose, 4-week, 13-week and 26-week oral toxicity studies in rats; (iii) 4-week, 13-week and 39-week oral toxicity studies in dogs; (iv) pre-natal development studies in rats and rabbits; and (v) genotoxicity tests of in vitro bacterial reverse mutation, chromosome aberration, and in-vivo micronucleus.
The FDA will not approve the product unless compliance with current good manufacturing practice (GMP) regulations is satisfactory, and the NDA contains data that provide substantial evidence that the drug is safe and effective in the indication studied. After the FDA evaluates the NDA and the manufacturing facilities, it issues either an approval letter or a complete response letter.
The FDA will not approve the product unless compliance with current good manufacturing practice (GMP) regulations is satisfactory, and the NDA contains data that provides substantial evidence that the drug is safe and effective in the indication studied. After the FDA evaluates the NDA and the manufacturing facilities, it issues either an approval letter or a complete response letter.
Unless otherwise informed by the FDA, for an accelerated approval product an applicant must submit to the FDA for consideration during the preapproval review period copies of all promotional materials, including promotional labeling as well as advertisements, intended for dissemination or publication within 120 days following marketing approval.
Unless otherwise informed by the FDA, for an accelerated approval product an applicant must submit to the FDA for consideration during the pre-approval review period copies of all promotional materials, including promotional labeling as well as advertisements, intended for dissemination or publication within 120 days following marketing approval.
Moreover, the time-in-range, the percentage of how long blood glucose value is within 70~180mg/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 DA-1241 increased secretion of gut peptide hormones such as GLP-1, GIP and PYY in gastrointestinal tracts after taking meals.
Our competitors also may obtain marketing approvals for their products more rapidly than we may obtain approval for our products, which could result in our competitors establishing a strong market position before we are able to 15 ​ Table of Contents enter the market.
Our competitors also may obtain marketing approvals for their products more rapidly than we may obtain approval for our products, which could result in our competitors establishing a strong market position before we are able to 17 Table of Contents enter the market.
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; 22 ​ Table of Contents or imposition of distribution or other restrictions under a REMS program.
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.
DA-1726 As of December 31, 2023, our exclusively licensed intellectual property portfolio for DA-1726 includes two U.S. patents directed to both composition of matter and use of the composition and one U.S. non-provisional patent application directed to both composition of matter and use of the composition.
DA-1726 As of December 31, 2024, our exclusively licensed intellectual property portfolio for DA-1726 includes two U.S. patents directed to both composition of matter and use of the composition and one U.S. non-provisional patent application directed to both composition of matter and use of the composition.
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 US 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 trial in the U.S. T2DM patients.
Moreover, impaired insulin action and lipid metabolism which are frequently observed in T2DM patients are highly associated with the pathogenesis of steatosis and inflammation in MASH. Extensive non-clinical studies have shown DA-1241 has therapeutic potential for the reduction in hepatic steatosis, inflammation, fibrosis, and improved glucose control regardless of body weight reduction.
Moreover, impaired insulin action and lipid metabolism which are frequently observed in T2DM patients are highly associated with the pathogenesis of steatosis and inflammation in MASH. Extensive non-clinical studies have 6 Table of Contents shown DA-1241 has therapeutic potential for the reduction in hepatic steatosis, inflammation, fibrosis, and improved glucose control regardless of body weight reduction.
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 reference listed drug (“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 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.
If these third-party payers do not consider our products to be cost-effective compared to other available therapies, they may not cover 27 ​ Table of Contents 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 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.
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.
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.
The principal purposes of our equity and cash incentive plans are to attract, retain and reward personnel through the granting of stock-based and cash-based compensation awards, in order to increase stockholder 29 ​ Table of Contents value and the success of our company by motivating such individuals to perform to the best of their abilities and achieve our objectives.
The principal purposes of our equity and cash incentive plans are to attract, retain and reward personnel through the granting of stock-based and cash-based compensation awards, in order to increase stockholder value and the success of our Company by motivating such individuals to perform to the best of their abilities and achieve our objectives.
Conditions for exclusivity include the FDA's determination that 21 ​ Table of Contents 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 reporting on, the requested studies within the statutory timeframe.
Accordingly, non-clinical studies have shown that DA-1726 not only reduces food intake but also increases energy expenditure even at the basal resting state, leading to persistent weight loss in diet-induced obese mice and rats. DA-1726 directly lowers blood glucose and lipid levels in addition to the accompanying metabolic improvement 10 ​ Table of Contents by weight loss.
Accordingly, non-clinical studies have shown that DA-1726 not only reduces food intake but also increases energy expenditure even at the basal resting state, leading to persistent weight loss in diet-induced obese mice and rats. DA-1726 directly lowers blood glucose and lipid levels in addition to the accompanying metabolic improvement by weight loss.
The FDA has committed to reviewing 90% of NDA resubmissions within two to six months depending on the type of information included in response to the deficiencies identified in the CRL. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.
The FDA has 21 Table of Contents committed to reviewing 90% of NDA resubmissions within two to six months depending on the type of information included in response to the deficiencies identified in the CRL. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.
DA-1241 Phase 2a Trial We are currently conducting 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.
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.
Corporate Information NeuroBo 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.neurobopharma.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 report.
The Pfizer Agreement includes milestone payments to Pfizer and tiered royalties on a country-by-country basis based upon the annual amount of net sales as specified in the Pfizer Agreement. The Pfizer Agreement will expire upon expiration of the last royalty term.
The Pfizer Agreement includes milestone payments to Pfizer and tiered royalties on a country-by-country basis based upon the annual amount of net sales as specified in the Pfizer Agreement. 16 Table of Contents The Pfizer Agreement will expire upon expiration of the last royalty term.
Weight reduction is closely related to the alleviation of fatty liver. Having stabilized the fragile peptide through several unique modifications, DA-1726 is predicted to be available as a once-weekly regimen to humans.
Weight reduction is closely related to the alleviation of fatty liver. Having 12 Table of Contents stabilized the fragile peptide through several unique modifications, DA-1726 is predicted to be available as a once-weekly regimen to humans.
Specifically, the applicant must certify either that: (i) the 23 ​ Table of Contents required patent information has not been filed; (ii) the listed patent has expired; (iii) the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or (iv) the listed patent is invalid or will not be infringed by the generic product.
Specifically, the applicant must certify either that: (i) the required patent information has not been filed; (ii) the listed patent has expired; (iii) the listed patent has not expired but will expire on a particular date and approval is sought after patent expiration; or (iv) the listed patent is invalid or will not be infringed by the generic product.
Exploratory P1b Study in the U.S.: Glucose-Lowering Effects Mean Change in Postprandial Glucose Excursion at Week 8 9 ​ Table of Contents In the parameters of glycemic variability measured with a Continuous Glucose Monitoring (“CGM”) 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 DA-1241 was similar to that of sitagliptin.
Agonism of GPR119 in the gut promotes the release of key gut peptides, glucagon-like peptide-1 (“GLP-1”), glucose-dependent insulinotropic polypeptide (“GIP”), and peptide YY (“PYY”). These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. DA-1241 has beneficial effects on glucose, lipid profile and liver inflammation, supported by potential efficacy demonstrated during in vivo preclinical studies.
Agonism of GPR119 in the gut promotes the release of key gut peptides, glucagon-like peptide-1 (“GLP-1”), glucose-dependent insulinotropic polypeptide (“GIP”), and peptide YY (“PYY”). These peptides play a further role in glucose metabolism, lipid metabolism and weight loss. DA-1241 has demonstrated beneficial effects on glucose, lipid profile and liver inflammation, as demonstrated during in-vivo preclinical studies.
It is a long-acting, novel peptide drug candidate, with a Phase 1 IND approved by the FDA with therapeutic potential for obesity. Activation of GLP1R contributes to central anorexic effect (appetite suppression) and activation of GCGR peripherally enhances basal metabolic rate.
It is a long-acting, novel peptide drug candidate, with a Phase 1 investigational new drug (“IND”) approved by the FDA with therapeutic potential for obesity. Activation of GLP1R contributes to central anorexic effect (appetite suppression) and activation of GCGR peripherally enhances basal metabolic rate.
The characteristic of the MRP is that the procedure builds on an already—existing marketing authorization in a member state of the European Union that is used as a reference in order to obtain marketing authorizations in other European Union member states.
The characteristic of the MRP is that the procedure builds on a pre-existing marketing authorization in a member state of the European Union that is used as a reference in order to obtain marketing authorizations in other European Union member states.
Information related to the product, patient population, phase of investigation, study sites and investigator, and other aspects of the clinical trial is made public as part of the registration. Sponsors are also obligated to disclose the results of these trials after completion.
National Institutes of Health (“NIH”). Information related to the product, patient population, phase of investigation, study sites and investigator, and other aspects of the clinical trial is made public as part of the registration. Sponsors are also obligated to disclose the results of these trials after completion.
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 NeuroBo designated as “Series A Convertible Preferred Stock”, par value $0.001 per share (the “Series A Preferred Stock”), under the terms of the Securities Purchase Agreement (the “Upfront License Payment”); (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 (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.
Therefore, DA-1241 treatment reduced the levels of plasma liver enzymes (ALT, AST), which were increased due to liver tissue damage in DIO-MASH mice.
Therefore, DA-1241 treatment reduced the levels of plasma liver enzymes (ALT, AST), which were increased due to liver tissue 7 Table of Contents damage in DIO-MASH mice.
Phase 1b, Part 1 was a double-blind placebo-controlled, multiple-ascending dose (“MAD”), single-center study of DA-1241 in healthy subjects. Overall, 24 male subjects were blinded and randomized to receive DA-1241: 50, 100 or 200 mg or placebo, as single daily oral doses for 28 days.
Phase 1b, Part 1 was a double-blind placebo-controlled, MAD, single-center study of DA-1241 in healthy subjects. Overall, 24 male subjects were blinded and randomized to receive DA-1241: 50 mg, 100 mg or 200 mg or placebo, as single daily oral doses for 28 days.
DA-1241 As of December 31, 2023, our exclusively licensed intellectual property portfolio for DA-1241 includes one U.S. patent directed to both composition of matter and a process of making the composition and three U.S. non-provisional patent applications directed to both composition of matter and use of the composition.
DA-1241 As of December 31, 2024, our exclusively licensed intellectual property portfolio for DA-1241 includes one U.S. patent directed to both composition of matter and a process of making the composition, one U.S. non-provisional patent directed to both composition of matter and use of the composition and two U.S. non-provisional patent applications directed to both composition of matter and use of the composition.
Gemcabene has also shown additive LDL-C lowering in combination with stable low, moderate or high-intensity statin therapy. As described below, we licensed global rights to Gemcabene from Pfizer in April 2011.
Gemcabene has also shown additive LDL- 15 Table of Contents C lowering in combination with stable low, moderate or high-intensity statin therapy. As described below, we licensed global rights to Gemcabene from Pfizer in April 2011.
In all cases, the clinical trials must be conducted in accordance with the International Conference on Harmonization (“ICH”) guidelines on GCP and other applicable regulatory requirements. To obtain regulatory approval to place a drug on the market in the European Union, we must submit a marketing authorization application.
In all cases, the clinical trials must be 27 Table of Contents conducted in accordance with the International Conference on Harmonization guidelines on GCP and other applicable regulatory requirements. To obtain regulatory approval to place a drug on the market in the European Union, we must submit a marketing authorization application.
Explore various avenues to advance DA-1726 to FDA approval, including seeking ways to expedite the clinical trials and conducting non-clinical studies. ● Pursue additional pipelines and/or other technologies . With both DA-1241 and DA-1726 in clinical trials, we will explore adding (i) clinical stage product candidates to diversify and enrich our pipeline and/or (ii) other technologies.
Explore various avenues to advance DA-1726 through the FDA approval process, including seeking ways to expedite clinical trials and conducting non-clinical studies. ● Pursue additional pipelines and/or other business opportunities . With both DA-1241 and DA-1726 in clinical trials, we plan to explore adding (i) clinical stage product candidates to diversify and enrich our pipeline and/or (ii) other technologies.
The FDA determines at the time that the marketing application is 20 ​ Table of Contents submitted, on a case- by-case basis, whether the proposed drug represents a significant improvement when compared with other available therapies.
The FDA determines at the time that the marketing application is submitted, on a case- by-case basis, whether the proposed drug represents a significant improvement when compared with other available therapies.
Risk Factor. ​ 6 ​ Table of Contents Our Strategy Our goal is to discover, develop and commercialize 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 DA-1241 through the FDA regulatory process to obtain approval for the treatment of MASH.
With successful proof of concept in the Phase 2a trial, we will be exploring other combination therapies that can benefit from the mechanism of action of DA-1241 and 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 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.
The two issued U.S. patents are expected to expire in July 2035, excluding any additional term for patent term adjustments or patent term extensions. NeuroBo’s intellectual property portfolio for DA-1241 also includes 22 non-U.S. patents and 39 non-U.S. patent applications directed to composition of matter and/or use of the composition.
The two issued U.S. patents are expected to expire in July 2035, excluding any additional term for patent term adjustments or patent term extensions. MetaVia’s intellectual property portfolio for DA-1241 also includes 28 non-U.S. patents and 33 non-U.S. patent applications directed to composition of matter and/or use of the composition.
Either party may terminate the Pfizer Agreement for the other party's material breach following a cure period or immediately upon certain insolvency events relating to the other 14 ​ Table of Contents party.
Either party may terminate the Pfizer Agreement for the other party's material breach following a cure period or immediately upon certain insolvency events relating to the other party.
In complying with cGMP regulations, pharmaceutical manufacturers must expend resources and time to ensure compliance with product specifications as well as production, record keeping, quality control, reporting and other requirements. Competition The pharmaceutical and biotechnology industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products.
The FDA typically inspects manufacturing facilities every two years. In complying with cGMP regulations, pharmaceutical manufacturers must expend resources and time to ensure compliance with product specifications as well as production, record keeping, quality control, reporting and other requirements. Competition The pharmaceutical and biotechnology industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products.
In practice, the performance goals established pursuant to the Prescription Drug User Fee Act have effectively 19 ​ Table of Contents extended the initial review cycle beyond 180 days.
In practice, the performance goals established pursuant to the Prescription Drug User Fee Act have effectively extended the initial review cycle beyond 180 days.
Exploratory P1b Study in the U.S.: Target-related Biomarker Change * & ** P Total GLP-1 Secretion during Mixed Meal Tolerance Test In terms of safety, no clinically significant adverse events were observed following the 8-week treatment, confirming the tolerability of DA-1241, and the bodyweight showed a tendency to decrease.
The amount of secretion of such hormones increased in proportion to the extent of exposure to DA-1241. 8 Table of Contents Exploratory P1b Study in the U.S.: Target-related Biomarker Change * & ** P Total GLP-1 Secretion during Mixed Meal Tolerance Test In terms of safety, no clinically significant adverse events were observed following the 8-week treatment, confirming the tolerability of DA-1241, and the bodyweight showed a tendency to decrease.
Successful completion of the Phase 2a trial will establish the mechanism of action and an early signal of efficacy in MASH and T2DM, which will allow us to seek initiation of Phase 2b trial as monotherapy or in combination with dipeptidyl peptidase-4 (“DPP4”) inhibitor, GLP1R or other therapeutic candidates . ● Pursuit for DA-1241 combination therapy .
Successful completion of the Phase 2a trial is designed to establish the mechanism of action and an early signal of efficacy in MASH and T2DM, which will allow us to seek initiation of a Phase 2b trial as monotherapy or in combination with GLP1R or other therapeutic candidates . ● Pursuit for DA-1241 combination therapy .
The issued U.S. patent is expected to expire in 2038, excluding any additional term for patent term adjustments or patent term extensions. Our intellectual property portfolio for DA-1726 also includes 13 non-US patents and 22 non-US patent applications directed to composition of matter and/or use of the composition.
The issued U.S. patent is expected to expire in 2041, excluding any additional term for patent term adjustments or patent term extensions. Our intellectual property portfolio for DA-1726 also includes 19 non-U.S. patents and 16 non-U.S. patent applications directed to composition of matter and/or use of the composition.
The Prescription Drug Marketing Act (“PDMA”) imposes requirements and limitations upon the provision of drug samples to physicians, as well as prohibits states from licensing distributors of prescription drugs unless the state licensing program meets certain federal guidelines that include minimum standards for storage, handling and record keeping.
The Prescription Drug Marketing Act (“PDMA”) imposes requirements and limitations upon the provision of drug samples to physicians, as well as prohibits states from licensing distributors of prescription drugs unless the state licensing program meets certain federal guidelines that include minimum standards for storage, handling and record keeping. In addition, the PDMA sets forth civil and criminal penalties for violations.
Our Pipeline Our focus is on two cardiometabolic assets. Our lead asset DA-1241, is a GPR119 agonist, in Phase 2a trial for treatment of MASH. Our second asset is DA-1726, a GLP-1 receptor and glucagon receptor dual agonist, for treatment of obesity. The Phase 1 trial for DA-1726 is expected to be initiated within the first half of 2024.
Our Pipeline Our focus is on two cardiometabolic assets. Our lead asset DA-1241, is a GPR119 agonist, in Phase 2a trial for treatment of MASH. Our second asset is DA-1726, a GLP-1 receptor and glucagon receptor dual agonist, in Phase 1 for treatment of obesity.
The jurisdictions for the foreign patents and application include: Brazil, Canada, China, the European Patent Convention (including Austria, Belgium, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Spain, Switzerland, Turkey, and the United Kingdom), India, Japan, Mexico, the Republic of Korea, and Russia.
The issued patents have expiration dates ranging between October 2026 and July 2038. The jurisdictions for the foreign patents and application include: Brazil, China, the European Patent Convention (including Austria, Belgium, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Spain, Switzerland, Turkey, and the United Kingdom), India, Japan, the Republic of Korea, and Russia.
In addition, the PDMA sets forth civil and criminal penalties for violations. 24 ​ Table of Contents New Legislation and Regulations From time to time, legislation is drafted, introduced and passed in Congress that could significantly change the statutory provisions governing the testing, approval, manufacturing and marketing of products regulated by the FDA and relevant regulatory authorities outside the U.S.
New Legislation and Regulations From time to time, legislation is drafted, introduced and passed in Congress that could significantly change the statutory provisions governing the testing, approval, manufacturing and marketing of products regulated by the FDA and relevant regulatory authorities outside the U.S.
Human Capital As of March 25, 2024, we had eight full-time employees, of which four were engaged in R&D functions, three were engaged in general and administrative functions, and one was engaged in both R&D and general and administrative functions. We have no collective bargaining agreements with our employees and have not experienced any work stoppages.
Human Capital As of March 17, 2025, we had nine full-time (and total) employees, of which five were engaged in R&D functions, three were engaged in general and administrative (“G&A”) functions, and one was engaged in both R&D and G&A functions. We have no collective bargaining agreements with our employees and have not experienced any work stoppages.
The following illustrates the current status of our assets as of filing date of this Annual Report. DA-1241 Treatment of MASH DA-1241 is a potential first-in-class G protein-coupled receptor 119 (“GPR119”) candidate with therapeutic potential for MASH and T2DM that can be orally administered once a day.
The following illustrates the current status of our assets as of filing date of this Annual Report. DA-1241 Treatment of MASH D A-1241 is a potential first-in-class GPR119 agonist with therapeutic potential for MASH and T2DM that is designed to be orally administered once a day.
The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to health care, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA.
The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to health care, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. 30 Table of Contents In addition, other legislative changes have been proposed and adopted since the ACA was enacted.
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 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”) ● NB-02 for the treatment of cognitive impairment ● Gemcabene for the treatment of dyslipidemia Our operations have consisted principally of performing research and development (“R&D”) activities, preclinical developments, clinical trials, and raising capital.
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”).
In mice with metabolic diseases, the effects of DA-1241 on the MASH phenotypes (steatosis, inflammation, and fibrosis in the liver) are enhanced by the co-treatment with a DPP4 inhibitor compared to each treatment alone due to potentiated GLP-1 actions. 8 ​ Table of Contents Differentiated Anti-Inflammatory Effect in MASH Mice Result of Phase 1 U.S.
In mice with metabolic diseases, the effects of DA-1241 on the MASH phenotypes (steatosis, inflammation, and fibrosis in the liver) are enhanced by the co-treatment with a DPP4 inhibitor compared to each treatment alone due to potentiated GLP-1 actions. Result of Phase 1 U.S. Clinical Trial for DA-1241 Completed Phase 1a and 1b trials in the U.S. healthy subjects.
Under the FDCA and FDA guidance implementing the statutory requirement, an SPA is generally binding on the FDA except in limited circumstances, such as if the FDA identifies a substantial scientific issue essential to determining safety or efficacy after the study begins, public health concerns emerge that were unrecognized at the time of the protocol assessment, the sponsor and the FDA agree to the change in writing, or if the study sponsor fails to follow the protocol that was agreed upon with the FDA.
Under the FDCA and FDA guidance implementing the statutory requirement, an SPA is generally binding on the FDA except in limited circumstances, such as if the FDA identifies a substantial scientific issue essential to determining safety or efficacy after the study begins, public health concerns emerge that were unrecognized at the time of the protocol assessment, the sponsor and the FDA agree to the change in writing, or if the study sponsor fails to follow the protocol that was agreed upon with the FDA. 23 Table of Contents Disclosure of Clinical Trial Information Sponsors of clinical trials of certain FDA-regulated products, including prescription drugs, are required to register and disclose certain clinical trial information on a public website maintained by the U.S.

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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.
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.
In many cases, the products that we commercialize will compete with existing, market-leading products. Many of our potential competitors have significantly greater financial, manufacturing, marketing, drug development, technical and human resources than we do. Large pharmaceutical companies, in particular, have extensive experience in clinical testing, obtaining regulatory approvals, recruiting patients and in manufacturing pharmaceutical products.
In many cases, the products that we commercialize will compete with existing, market-leading products. Many of our potential competitors have significantly greater financial, manufacturing, marketing, drug development, technical and human resources than we do. Large pharmaceutical companies, in particular, have extensive experience in clinical testing, obtaining regulatory approvals, recruiting patients and manufacturing pharmaceutical products.
Patients are unlikely to use a product candidate, if approved, unless coverage is provided, and reimbursement is adequate to cover all or a significant portion of the cost of our products. Therefore, coverage and adequate reimbursement is critical to new product acceptance.
Patients are unlikely to use a product candidate, if approved, unless coverage is provided, and reimbursement is adequate to cover all or a significant portion of the cost of our products. Therefore, coverage and adequate reimbursement are critical to new product acceptance.
We do not have a sales or marketing infrastructure and have no experience in the sale, marketing or distribution of pharmaceutical products. To achieve commercial success for any approved product for which we retain sales and marketing responsibilities, we must either develop a sales and marketing organization or outsource these functions to other third parties.
We do not have sales or marketing infrastructure and have no experience in the sale, marketing or distribution of pharmaceutical products. To achieve commercial success for any approved product for which we retain sales and marketing responsibilities, we must either develop a sales and marketing organization or outsource these functions to other third parties.
Even if marketing approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the medicine.
Even if the marketing approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the medicine.
Current and future legislation may increase the difficulty and cost of obtaining marketing approval of and commercialization of our product candidates and affect the prices we may obtain.
Current and future legislation may increase the difficulty and cost of obtaining marketing approval and commercialization of our product candidates and affect the prices we may obtain.
If any issues arise in the manufacturing and we are unable to arrange for alternative third-party manufacturing sources, we are unable to find an alternative third party capable of reproducing the existing manufacturing method or we are unable to do so on commercially reasonable terms or in a timely manner, we may not be able to complete development of our product candidates, or market or distribute them.
If any issues arise in the manufacturing and we are unable to arrange for alternative third-party manufacturing sources, we are unable to find an alternative third party capable of reproducing the existing manufacturing method or we are unable to do so on commercially reasonable terms or in a timely manner, we may not be able to complete the development of our product candidates, or market or distribute them.
If future collaboration partners fail to develop or effectively commercialize our product candidates or any future product candidate for any of these reasons, such product candidate may not be approved for sale and our sales of such product candidate, if approved, may be limited, which would have an adverse effect on our operating results and financial condition.
If future collaboration partners fail to develop or effectively commercialize our product candidates or any future product candidate for any of these reasons, such candidate may not be approved for sale and our sales of such product candidate, if approved, may be limited, which would have an adverse effect on our operating results and financial condition.
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.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of current stockholders may be materially diluted, and the terms of such securities could include liquidation or other preferences that adversely affect the rights of our current stockholders.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of current stockholders may be materially diluted, and the terms of such securities could include liquidation preferences or other preferences that adversely affect the rights of our current stockholders.
We are a controlled company within the meaning of the Nasdaq listing requirements and as a result, may rely on exemptions from certain corporate governance requirements. To the extent we rely on such exemptions, you will not have the same protections afforded to stockholders of companies that are subject to such corporate governance requirements.
We are a controlled company within the meaning of Nasdaq listing requirements and as a result, may rely on exemptions from certain corporate governance requirements. To the extent we rely on such exemptions, you will not have the same protections afforded to stockholders of companies that are subject to such corporate governance requirements.
Because of the voting power over our Company held by Dong-A and the Investor Rights Agreement between such parties, we are considered a controlled company for the purposes of the Nasdaq listing requirements.
Because of the voting power over our Company held by Dong-A and the Investor Rights Agreement between such parties, we are considered a controlled company for the purposes of Nasdaq listing requirements.
We may fail to comply with the continued listing requirements of the Nasdaq, such that our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted. Our common stock is listed for trading on Nasdaq.
We may fail to comply with the continued listing requirements of Nasdaq, such that our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted. Our common stock is listed for trading on Nasdaq.
A delisting of our common stock from Nasdaq could materially reduce the liquidity of our common stock and result in a corresponding material reduction in the price of our common stock.
The delisting of our common stock from Nasdaq could materially reduce the liquidity of our common stock and result in a corresponding material reduction in the price of our common stock.
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; 46 ​ 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 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; 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.
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; 37 ​ Table of Contents ● 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.
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 any product candidate we develop were to receive marketing approval or be commercialized for use in combination with other existing therapies, we would continue to be subject to the risks that the FDA or similar regulatory authorities outside of the U.S. could revoke approval of the therapy used in combination with our product candidate or that safety, efficacy, manufacturing or supply issues could arise with these existing therapies.
Even if any product candidate we develop were to receive marketing approval or be commercialized for use in combination with other existing therapies, we would continue to be subject to the risks that the FDA or similar regulatory authorities outside of the U.S. could revoke approval of the therapy used in combination with our product candidate or that safety, dosage, efficacy, manufacturing or supply issues could arise with these existing therapies.
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 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 trials.
It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity, such as employee training, may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.
It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity, such as employee training, may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from failure to be in compliance with such laws or regulations.
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-1 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, 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.
Product liability claims might be brought against us by patients, healthcare providers or others selling or otherwise coming into contact with any of our products or future product candidate during product testing, manufacturing, marketing or sale. For example, we may be sued on allegations that a product candidate caused injury or that the product is otherwise unsuitable.
Product liability claims might be brought against us by patients, healthcare providers or others selling or otherwise coming into contact with any of our products or future product candidates during product testing, manufacturing, marketing or sale. For example, we may be sued on allegations that a product candidate caused injury or that the product is otherwise unsuitable.
As a result, we may be forced to bring claims against third parties, or defend claims that they bring against us, to determine ownership of what we regard as our intellectual property. Monitoring unauthorized disclosure is difficult and we do not know whether the procedures that we have followed to prevent such disclosure are or will be adequate.
As a result, we may be forced to bring claims against third parties, or defend claims that they bring against us, to determine ownership of what we regard as our intellectual property. Monitoring unauthorized disclosures is difficult and we do not know whether the procedures that we have followed to prevent such disclosure are or will be adequate.
To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be harmed, possibly materially.
To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be materially harmed.
General Risk Factors Our business and operations may suffer in the event of system failures or unplanned events. Despite the implementation of security measures, our internal computer systems and those of our current and future contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures.
General risk factors Our business and operations may suffer in the event of system failures or other unplanned events. Despite the implementation of security measures, our internal computer systems and those of our current and future contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures.
Clinical trials may be delayed, suspended or terminated for a variety of reasons, such as: ● delay or failure in reaching 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; 34 ​ Table of Contents ● 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 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.
If we enter into arrangements with third parties to perform sales, marketing and distribution services, our product revenue or the profitability of these product revenue may be lower than if we were to market and sell any products that we develop ourselves.
If we enter into arrangements with third parties to perform sales, marketing and distribution services, our product revenue or the profitability of these product revenues may be lower than if we were to market and sell any products that we develop ourselves.
We do not anticipate declaring or paying, in the foreseeable future, any cash dividends on our capital stock and, consequently, the ability of our stockholders to achieve a return on their investment will depend on appreciation in the price of our common stock.
We do not anticipate declaring or paying, in the foreseeable future, any cash dividends and, consequently, the ability of our stockholders to achieve a return on their investment will depend on appreciation in the price of our common stock.
For example: ● others may be able to make product candidates that are similar to our product candidates but that are not covered by the claims of the patents that we own or have exclusively licensed; 51 ​ Table of Contents ● we or our future licensors or collaborators might not have been the first to make the inventions covered by the issued patent or pending patent application that we own or have exclusively licensed; ● we or our future licensors or collaborators might not have been the first to file patent applications covering certain of our inventions; ● others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; ● it is possible that our pending patent applications will not lead to issued patents; ● issued patents that we own or have exclusively licensed may be held invalid or unenforceable, as a result of legal challenges by our competitors; ● our competitors might conduct R&D activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; ● we may not develop additional proprietary technologies that are patentable; and ● the patents of others may have an adverse effect on our business.
For example: ● others may be able to make product candidates that are similar to our product candidates but that are not covered by the claims of the patents that we own or have exclusively licensed; ● we or our future licensors or collaborators might not have been the first to make the inventions covered by the issued patent or pending patent application that we own or have exclusively licensed; ● we or our future licensors or collaborators might not have been the first to file patent applications covering certain of our inventions; ● others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; ● it is possible that our pending patent applications will not lead to issued patents; ● issued patents that we own or have exclusively licensed may be held invalid or unenforceable, as a result of legal challenges by our competitors; ● our competitors might conduct R&D activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; ● we may not develop additional proprietary technologies that are patentable; and ● the patents of others may have an adverse effect on our business.
Our dependence on collaborative partners subjects it to a number of risks, including, but not limited to, the following: ● We may not be able to control the amount or timing of resources that collaborative partners devote to our research programs and product candidates; ● We may be required to relinquish significant rights, including intellectual property, marketing and distribution rights; ● We rely on the information and data received from third parties regarding our research programs and product candidates and will not have control of the process conducted by the third party in gathering and composing such data and information.
Our dependence on collaborative partners subjects us to a number of risks, including, but not limited to, the following: ● We may not be able to control the amount or timing of resources that collaborative partners devote to our research programs and product candidates; ● We may be required to relinquish significant rights, including intellectual property, marketing and distribution rights; ● We rely on the information and data received from third parties regarding our research programs and product candidates and will not have control of the process conducted by the third party in gathering and composing such data and information.
We are continuing to test and develop our product candidates and may explore possible design or formulation changes to address safety, efficacy, manufacturing efficiency and performance issues to the extent any arise.
We are continuing to test and develop our product candidates and may explore possible design or formulation changes to address safety, dosage, efficacy, manufacturing efficiency and performance issues to the extent any arise.
We may engage in future acquisitions, mergers or in-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 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.
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.
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.
If our product candidates receive marketing approval and we or others identify undesirable side effects caused by such product candidates (or any other similar drugs) after such approval, a number of potentially significant negative consequences could result, including: ● regulatory authorities may withdraw or limit their approval of such product candidates; ● regulatory authorities may require the addition of labeling statements, such as a "boxed" warning or a contraindication; ● we may be required to recall the product, change the way such product candidates are distributed or administered, conduct additional clinical trials or change the labeling of the product candidates; ● regulatory authorities may require a Risk Evaluation and Mitigation Strategy (REMS) plan to mitigate risks, which could include medication guides to be distributed to patients, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools; ● we may be subject to regulatory investigations and government enforcement actions; ● we may be subject to fines, injunctions or the imposition of civil or criminal penalties; ● we may decide to remove such product candidates from the marketplace after they are approved; ● the product may be rendered less competitive, and sales may decrease; ● we could be sued and held liable for injury caused to individuals exposed to or taking our product candidates; and ● our reputation may suffer.
If our product candidates receive marketing approval and we or others identify undesirable side effects caused by such product candidates (or any other similar drugs) after such approval, a number of potentially significant negative consequences could result, including: ● regulatory authorities may withdraw or limit their approval of such product candidates; ● regulatory authorities may require the addition of labeling statements, such as a “boxed” warning or a contraindication; ● we may be required to recall the product, change the way such product candidates are distributed or administered, conduct additional clinical trials or change the labeling of the product candidates; ● regulatory authorities may require a REMS plan to mitigate risks, which could include medication guides to be distributed to patients, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools; ● we may be subject to regulatory investigations and government enforcement actions; ● we may be subject to fines, injunctions or the imposition of civil or criminal penalties; ● we may decide to remove such product candidates from the marketplace after they are approved; ● the product may be rendered less competitive, and sales may decrease; ● we could be sued and held liable for injury caused to individuals exposed to or taking our product candidates; and ● our reputation may suffer.
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; 35 ​ Table of Contents ● 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 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.
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 of directors (“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 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.
It is possible that other banks will face similar difficulty in the future. Although we do not maintain any deposit accounts, credit agreements or letters of credit with any financial institution currently in receivership, we are unable to predict the extent or nature of the impacts of these evolving circumstances at this time.
It is possible that other banks will face similar difficulties in the future. Although we do not maintain any deposit accounts, credit agreements or letters of credit with any financial institution currently in receivership, we are unable to predict the extent or nature of the impacts of these evolving circumstances at this time.
Ultimately, we could be prevented from commercializing a product candidate or technology or be forced to cease some aspect of our business operations if, as a result of actual or threatened infringement claims, we are unable to enter into licenses of the relevant intellectual property on acceptable terms.
Ultimately, we could be prevented from commercializing a product candidate or technology or be forced to cease some aspects of our business operations if, as a result of actual or threatened infringement claims, we are unable to enter into licenses of the relevant intellectual property on acceptable terms.
Periodic maintenance fees on any issued patent are due to be paid to the USPTO, and foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedurals, documentary, fee payment and other requirements during the patent application process.
Periodic maintenance fees on any issued patent are due to be paid to the USPTO, and foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other requirements during the patent application process.
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 shareholders, 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 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.
This could result in our own products being removed from the market or being less successful commercially. 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. 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.
If we cannot successfully defend against claims that our product caused injuries, we could incur substantial liabilities.
If we cannot successfully defend ourselves against claims that our product caused injuries, we could incur substantial liabilities.
The Tax Act also included a limitation of the deduction for net operating losses (“NOLs”) generated in tax years beginning after December 31, 2017 to 80% of current year taxable income and the general elimination of carrybacks of NOLs generated in taxable years ending after December 31, 2017.
The Tax Act also included a limitation of the deduction for net operating losses (“NOLs”) generated in tax years beginning after 2017 to 80% of current year taxable income and the general elimination of carrybacks of NOLs generated in taxable years ending after 2017.
If we do complete an acquisition, merger or license, we cannot assure you that it will ultimately strengthen our competitive position or that it will not be viewed negatively by customers, 45 ​ Table of Contents financial markets or investors.
If we do complete an acquisition, merger or license, we cannot 49 Table of Contents assure you that it will ultimately strengthen our competitive position or that it will not be viewed negatively by customers, financial markets or investors.
Provisions in our corporate charter documents and under Delaware law may make an acquisition of NeuroBo, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
Provisions in our corporate charter documents and under Delaware law may make an acquisition of MetaVia, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
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 that are not "emerging growth companies", 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 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.
Compliance with applicable environmental, health and safety laws and regulations are expensive, and current or future environmental regulations may impair our research, development and production efforts, which could harm our business, prospects, financial condition or results of operations 39 ​ Table of Contents We rely and will continue to rely on collaborative partners regarding the development of our research programs and product candidates.
Compliance with applicable environmental, health and safety laws and regulations are expensive, and current or future environmental regulations may impair our research, development and production efforts, which could harm our business, prospects, financial condition or results of operations. We rely and will continue to rely on collaborative partners regarding the development of our research programs and product candidates.
However, the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) signed into law in March 2020, provided that NOLs generated in a taxable year beginning in 2018, 2019 or 2020, may now be carried back five years. In addition, the 80% taxable income limitation is temporarily removed, allowing NOLs to fully offset net taxable income.
However, the Coronavirus Aid, Relief, and Economic Security Act signed into law in 2020, provided that NOLs generated in a taxable year beginning in 2018, 2019 or 2020, may now be carried back five years. In addition, the 80% taxable income limitation is temporarily removed, allowing NOLs to fully offset net taxable income.
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.
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.
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.
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.
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.
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.
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. 50 ​ Table of Contents We may be subject to damages resulting from claims that our employees or we have wrongfully used or disclosed alleged trade secrets of their former employers.
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. We may be subject to damages resulting from claims that our employees or we have wrongfully used or disclosed alleged trade secrets of their former employers.
In the past, securities class action litigation has often been instituted against companies following 54 ​ Table of Contents periods of volatility in the market price of a company's securities. This type of litigation, if instituted, could result in substantial costs and a diversion of management's attention and resources, which would harm our business, operating results or financial condition.
In the past, securities class action litigation has often been instituted against companies following periods of volatility in the market price of a company’s securities. This type of litigation, if instituted, could result in substantial costs and a diversion of management's attention and resources, which would harm our business, operating results or financial condition.
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 and the vote of all matters submitted to a vote of our shareholders, which enables them to control all corporate decisions.
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.
The concentration of ownership could deprive you of an opportunity to receive a premium for your shares of common stock as part of a sale of NeuroBo and ultimately might affect the market price of our common stock.
The concentration of ownership could deprive you of an opportunity to receive a premium for your shares of common stock as part of a sale of MetaVia and ultimately might affect the market price of our common stock.
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.
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 ordinary course of our business, our contract research organizations and other third parties on which we rely collect and store sensitive data, including legally protected patient health information, personally identifiable information about our 57 ​ Table of Contents employees, intellectual property, and proprietary business information. We manage and maintain our applications and data utilizing on-site systems.
In the ordinary course of our business, our contract research organizations and other third parties on which we rely collect and store sensitive data, including legally protected patient health information, personally identifiable information about our employees, intellectual property, and proprietary business information. We manage and maintain our applications and data utilizing on-site systems.
Our success depends in large part on our ability to obtain and maintain patent protection in the U.S. and other countries with 47 ​ Table of Contents respect to our proprietary technology and products.
Our success depends in large part on our ability to obtain and maintain patent protection in the U.S. and other 51 Table of Contents countries with respect to our proprietary technology and products.
As a result, Dong-A is able to exert a significant influence on the outcome of corporate actions requiring shareholder approval, including mergers, share capital increases and other extraordinary items.
As a result, Dong-A is able to exert a significant influence on the outcome of corporate actions requiring stockholder approval, including mergers, share capital increases and other extraordinary items.
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.
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.
In addition, this concentration of ownership may adversely affect the trading price of our common stock because investors may perceive disadvantages in owning shares in a company with significant stockholders. Dong-A and its affiliates engage in a broad spectrum of activities, including investments in the healthcare industry generally.
In addition, this concentration of ownership may adversely affect the trading price of our common stock because investors may perceive disadvantages in owning shares in a company with significant stockholders. 58 Table of Contents Dong-A and its affiliates engage in a broad spectrum of activities, including investments in the healthcare industry generally.
This concentration of ownership may delay, deter or prevent acts that would be favored by our other shareholders. The interests of Dong-A may not always coincide with our interests or the interests of our other shareholders.
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.
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: ● disagreement with the design or implementation of our clinical trials; ● disagreement with the sufficiency of our clinical trials; ● failure to demonstrate the safety and efficacy of the product candidate for the proposed indications; ● failure to demonstrate that any clinical and other benefits of the product candidate outweigh their safety risks; ● a negative interpretation of the data from our nonclinical studies or clinical trials; ● 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 ● 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 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.
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.
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.
Unauthorized access, loss or dissemination could also disrupt our operations, including our ability to conduct research, development and commercialization activities, process and prepare Company financial information, manage various general and administrative aspects of our business and damage our reputation, in addition to possibly requiring substantial expenditures of resources to remedy, any of which could adversely affect our business.
Unauthorized access, loss or dissemination could also disrupt our operations, including our ability to conduct research, development and commercialization activities, process and prepare company financial information, manage various G&A aspects of our business and damage our reputation, in addition to possibly requiring substantial expenditures of resources to remedy, any of which could adversely affect our business.
Obesity treatments range from behavioral modification to drugs and medical devices, and surgery, 36 ​ Table of Contents generally as a last resort. If DA-1726 were approved for obesity, our primary competition in the obesity treatment market would currently be from approved and marketed products, including semaglutide (WEGOVY ® ) and tirzepatide (Zepbound®).
Obesity treatments range from behavioral modification to drugs and medical devices, and surgery, generally as a last resort. If DA-1726 were approved for obesity, our primary competition in the obesity treatment market would currently be from approved and marketed products, including semaglutide (WEGOVY ® ) and tirzepatide (Zepbound®).
Our arrangements with third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute any product candidate for which we obtain marketing approval.
Our arrangements with third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute any product candidate for which we obtain 46 Table of Contents marketing approval.
Although we have begun to take measures to remediate these material weaknesses, the measures we have taken, and expect to take, to improve our internal controls may not be sufficient to address the issues identified, to ensure that our internal controls are effective or to ensure that the identified material weaknesses will not result in a material misstatement of our annual or interim consolidated financial statements.
Although we have begun to take measures to remediate this material weakness, the measures we have taken, and expect to take, to improve our internal controls may not be sufficient to address the issues identified, to ensure that our internal controls are effective or to ensure that the identified material weakness will not result in a material misstatement of our annual or interim consolidated financial statements.
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 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; 53 ​ Table of Contents ● 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; ● changes in general economic, political and market conditions in any of the regions in which we conduct our business; ● 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; ● 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.
Further, if we attempt to modify a product candidate or technology or to develop alternative methods or products in response to infringement claims or to avoid potential claims, we could incur substantial costs, encounter delays in product introductions or interruptions in sales. Ultimately, such efforts could be unsuccessful.
Further, if we attempt to modify a product candidate or technology or to develop alternative methods or products in response to infringement claims or to avoid potential claims, we could incur 53 Table of Contents substantial costs, encounter delays in product introductions or interruptions in sales. Ultimately, such efforts could be unsuccessful.
For example, on March 10, 2023 and March 12, 2023, the Federal Deposit Insurance Corporation took control and was appointed receiver of Silicon Valley Bank, Signature Bank and Silvergate Capital Corp, respectively, after each bank was unable to continue their operations. Since then, additional financial institutions have experienced similar failures and have been placed into receivership.
For example, in 2023, the Federal Deposit Insurance Corporation took control and was appointed receiver of Silicon Valley Bank, Signature Bank and Silvergate Capital Corp, respectively, after each bank was unable to continue their operations. Since then, additional financial institutions have experienced similar failures and have been placed into receivership.
Alternatively, if a court were to find this provision inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such matters in other jurisdictions, which could adversely affect our business and financial condition.
Alternatively, if a court were to find this provision inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such matters in other jurisdictions, which could adversely affect our business and financial condition. 62 Table of Contents ​ Item 1B.
In addition, we may not be successful in entering into arrangements with third parties to sell and market our product 40 ​ Table of Contents candidates or may be unable to do so on terms that are favorable to us.
In addition, we may not be successful in entering into arrangements with third parties to sell and market our product candidates or may be unable to do so on terms that are favorable to us.
During the course of our review and testing, we may identify deficiencies and be unable to remediate them before we must provide the required reports.
During the course of our review and testing, we may identify deficiencies or material weaknesses and be unable to remediate them before we must provide the required reports.
We require additional financing to accomplish our long-term business plan and failure to obtain necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our operations.
We require additional capital to accomplish our business plan and the failure to obtain necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our operations.
As of March 25, 2024, we had eight full-time employees. As our development and commercialization plans and strategies develop, or as a result of any future acquisitions, we may need additional managerial, operational, development, sales, marketing, financial and other resources. Our management, personnel and systems currently in place may not be adequate to support our future growth.
As of December 31, 2024, we had nine full-time employees. As our development and commercialization plans and strategies develop, or as a result of any future acquisitions, we may need additional managerial, operational, development, sales, marketing, financial and other resources. Our management, personnel and systems currently in place may not be adequate to support our future growth.
To the extent that any disruption or security breach were 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.
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.
If we are unable to raise additional funds through equity or debt financings 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 or acquisitions.
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.
We rely on trade secret, patent, copyright and trademark laws, and confidentiality, licensing and other agreements with employees and third parties, all of which offer only limited protection.
We rely on trade secrets, patents, copyright and trademark laws, and confidentiality, licensing and other agreements with employees and third parties, all of which offer only limited protection.
We may also be required to perform additional, unanticipated clinical trials to obtain approval or be subject to additional post marketing testing requirements to maintain regulatory approval. In addition, regulatory authorities may withdraw their approval of a product, or the FDA may require a risk evaluation and mitigation strategy (“REMS”) for a product, which could impose restrictions on our distribution.
We may also be required to perform additional, unanticipated clinical trials to obtain approval or be subject to additional post marketing testing requirements to maintain regulatory approval. In addition, regulatory authorities may withdraw their approval of a product, or the FDA may require a REMS for a product, which could impose restrictions on our distribution.
Because we intend to market our product candidates, if approved, outside of the U.S., our business is subject to risks associated with doing business outside of the U.S.
We intend to market our product candidates outside of the U.S., and if we do, we will be subject to the risks of doing business outside of the U.S. Because we intend to market our product candidates, if approved, outside of the U.S., our business is subject to risks associated with doing business outside of the U.S.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeThis involvement ensures that cybersecurity considerations are integrated into the broader strategic objectives of NeuroBo. 60 ​ Table of Contents 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.
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.
Our cybersecurity strategy focuses on implementing effective and efficient controls, technologies, and other processes to assess, identify, and manage material cybersecurity risks. Our cybersecurity program is designed to be aligned with applicable industry standards. We work with a third-party provider to monitor for threats and potential cybersecurity breaches.
Our cybersecurity strategy focuses on implementing effective and efficient controls, technologies, and other processes to assess, identify, and manage material cybersecurity risks. Our cybersecurity program is designed to be aligned with applicable industry standards. We work with a third-party provider to monitor threats and potential cybersecurity breaches.
That program is utilized in making decisions with respect to company priorities, resource allocations, and oversight structures. The Board is assisted by the audit committee, which reviews our cybersecurity program with management and reports to the Board. The audit committee is central to the Board’ oversight of cybersecurity risks and bears the primary responsibility for this domain.
That program is utilized in making decisions with respect to Company priorities, resource allocations, and oversight structures. The Board is assisted by the audit committee, which reviews our cybersecurity program with management and reports to the Board. The audit committee is central to the Board’s oversight of cybersecurity risks and bears the primary responsibility for this domain.
While we have not, as of the date of this Form 10-K, experienced a cybersecurity threat or incident that resulted in a material adverse impact to our business or operations, there can be no guarantee that we will not experience such an incident in the future. We aim to incorporate industry best practices throughout our cybersecurity program.
While we have not, as of the date of this Annual Report, experienced a cybersecurity threat or incident that resulted in a material adverse impact to our business or operations, there can be no guarantee that we will not experience such an incident in the future. We aim to incorporate industry best practices throughout our cybersecurity program.
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. ​
Furthermore, 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. ​
The audit committee actively participates in strategic decisions related to cybersecurity, offering guidance and approval for major initiatives.
The audit committee actively participates in strategic decisions related to cybersecurity, offering guidance and approval for major initiatives. This involvement ensures that cybersecurity considerations are integrated into the broader strategic objectives of MetaVia.

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 new 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 to renew for an additional two-year term. The lease commenced in September 2023 and expires in August 2026.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Common stock Our common stock is listed on Nasdaq under the symbol “NRBO.” In December 2023, we completed a one-for-eight reverse stock split of our common stock (the “2023 Reverse Stock Split”).
Biggest changeItem 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.
Any 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. ​ Item 6. [Reserved] ​ ​
Any 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.
Removed
As a result, every eight shares of our issued and outstanding common stock were combined, converted and changed into one share of our common stock.
Added
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.
Removed
Any fraction of a share of our common stock that was created as a result of the 2023 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.
Added
Purchases of equity securities by the issuer and affiliated purchasers None. ​ Item 6. [Reserved] ​ ​
Removed
The 2023 Reverse Stock Split was initially approved by our stockholders at the annual meeting of stockholders in J une 2023.
Removed
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-eight to be determined at the discretion of our Board.
Removed
Following the annual meeting, our Board approved a one-for-eight reverse stock split of our issued and outstanding shares of common stock. In September 2022, we completed a 1-for-30 reverse stock split of our common stock (the “2022 Reverse Stock Split”).
Removed
As a result, every thirty shares of our issued and outstanding common stock were combined, converted and changed into one share of our common stock.
Removed
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.
Removed
The 2022 Reverse Stock Split was initially approved by our stockholders at the annual meeting of stockholders in J une 2022.
Removed
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-five to be determined at the discretion of our Board.
Removed
Following the annual meeting, our Board approved a one-for-thirty reverse stock split of our issued and outstanding shares of common stock. Neither the 2023 Reverse Stock Split nor the 2022 Reverse Stock Split impacted the number of authorized shares of common stock of 100,000,000 shares.
Removed
For each of the reverse stock splits, 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.
Removed
Specifically, for the Series A and B warrants issued 61 ​ Table of Contents in November 2022 that were outstanding on December 20, 2023, the number of outstanding warrants did not change; instead, the warrants have an exchange ratio of eight warrants for one share of our common stock.
Removed
In this Annual Report, all historical numbers of shares of common stock and per share data have been adjusted to give effect to the 2023 Reverse Stock Split and the 2022 Reverse Stock Split.
Removed
Additionally, since the common stock par value was unchanged, historical amounts for common stock and additional paid-in capital have been adjusted to give effect to the 2023 Reverse Stock Split and the 2022 Reverse Stock Split. Stockholders On March 25, 2024, we had 4,906,032 shares of common stock outstanding and 52 holders of record of our common stock.

Item 7. Management's Discussion & Analysis

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

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Biggest changeThe following table reflects the major categories of cash flows for each of the periods presented (in thousands). ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2023 ​ 2022 Net cash used in operating activities ​ $ (10,799) ​ $ (11,712) Net cash (used in) provided by investing activities ​ (50) ​ ​ 8 Net cash (used in) provided by financing activities ​ (80) ​ ​ 28,681 Net (decrease) increase in cash ​ $ (10,929) ​ $ 16,977 Operating Activities Net cash used in operating activities was $10.8 million for 2023, a decrease of $0.9 million, or 7.8%, compared to $11.7 million for 2022.
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.
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; 65 ​ Table of Contents ● 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 our 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; ● 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.
Our cash balance includes liquid insured deposits, which are obligations of the program 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.
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.
This process involves reviewing open contracts and purchase orders, communicating with applicable personnel to identify services that have been performed on our behalf and estimating the level of service performed 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 open contracts and purchase orders, communicating with applicable 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 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 performed 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 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.
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 ● payments made under third-party licensing agreements.
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.
Accordingly, we have no liabilities recorded for these provisions as of December 31, 2023 and 2022. 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, 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.
The maximum potential amount of future payments we could be required to make under these indemnification provisions is sometimes unlimited. We have not 69 ​ Table of Contents incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. As a result, the estimated fair value of liabilities relating to these provisions is minimal.
The maximum potential amount of future payments we could be required to make under these indemnification provisions is sometimes unlimited. We have not incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. As a result, the estimated fair value of liabilities relating to these provisions is minimal.
We anticipate that our general and administrative expenses will increase in the future as a result of accounting, audit, legal, regulatory, compliance, and director and officer insurance costs as we pursue the development of our product pipeline, as well as investor and public relations expenses associated with being a public company.
We anticipate that our G&A expenses will increase in the future as a result of accounting, audit, legal, regulatory, compliance, and director and officer insurance costs as we pursue the development of our product pipeline, as well as investor and public relations expenses associated with being a public 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; 63 ​ 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.
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.
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.
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.
These agreements are typically with business partners, clinical sites, and suppliers. Pursuant to these agreements, we generally agree to indemnify, hold harmless, and reimburse indemnified parties for losses suffered or incurred by the indemnified parties with respect to our products or product candidates, use of such products or product candidates, or other actions taken or omitted by us.
Pursuant to these agreements, we generally agree to indemnify, hold harmless, and reimburse indemnified parties for losses suffered or incurred by the indemnified parties with respect to our products or product candidates, use of such products or product candidates, or other actions taken or omitted by us.
Our consolidated financial statements, included elsewhere in this Annual Report, have been prepared assuming that we will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of our assets and the satisfaction of our liabilities in the normal course of business.
The determination as to whether we can continue as a going concern contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Our consolidated financial statements have been prepared assuming that we will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.
DA-1241 has beneficial effects on glucose, lipid profile and liver inflammation, supported by potential efficacy demonstrated during in vivo preclinical studies. ● DA-1726 is a novel oxyntomodulin analogue functioning as a GLP-1 receptor (“GLP1R”) and glucagon receptor (“GCGR”) dual agonist for the treatment of obesity that is to be administered once weekly subcutaneously.
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.
R&D expenses consist primarily of costs incurred in connection with the development of our product candidates.
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.
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. These conditions raise substantial doubt about our ability to continue as a going concern.
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.
As reflected in the consolidated financial statements, we had $22.4 million in cash as of December 31, 2023. We have experienced net losses and negative cash flows from operating activities since our inception and had an accumulated deficit of $108.3 million as of December 31, 2023.
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.
Our critical accounting estimates and judgements relate to the following items: (i) clinical trial costs and accruals, (ii) fair value of stock-based compensation, (iii) fair value of warrants, and (iv) cash forecast for conclusion about NeuroBo’s ability to continue as a going concern.
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.
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. As of December 31, 2023 and 2022, our U.S. federal NOL carryforwards were $8.8 million and $1.5 million, respectively.
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.
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. Our net loss was $12.5 million and $14.0 million for 2023 and 2022, respectively.
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.
Results of Operations 2023 compared to 2022 The following table summarizes our results of operations for 2023 and 2022 (in thousands, other than share and per share amounts): ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2023 ​ 2022 Operating expenses: ​ ​ ​ ​ ​ ​ Research and development ​ $ 9,158 ​ $ 2,778 Acquired in-process research and development ​ ​ — ​ ​ 8,210 General and administrative ​ ​ 6,728 ​ ​ 8,640 Total operating expenses ​ 15,886 ​ 19,628 Loss from operations ​ (15,886) ​ (19,628) Other income (expense): ​ ​ ​ ​ ​ ​ Change in fair value of warrant liabilities ​ ​ 2,955 ​ ​ 7,935 Interest income ​ ​ 461 ​ ​ — Financing expense ​ ​ — ​ ​ (2,191) Other expense ​ ​ — ​ ​ (83) Total other income ​ ​ 3,416 ​ ​ 5,661 Loss before income taxes ​ ​ (12,470) ​ ​ (13,967) Provision for income taxes ​ ​ — ​ ​ — Net loss ​ $ (12,470) ​ $ (13,967) Loss per share of common stock, basic and diluted ​ $ (2.46) ​ $ (43.42) Weighted average shares of common stock, basic and diluted ​ 5,071,101 ​ 321,703 Operating expenses and loss from operations Our total operating expenses and loss from operations for 2023 were $15.9 million, a decrease of $3.7 million, or 19.1%, compared to 2022.
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.
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. We recorded an accrual for external R&D costs of $3.8 million and $0.1 million as of December 31, 2023 and 2022, respectively.
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.
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.
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.
We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $250 thousand per bank.
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 incurred a net loss of $12.5 million and used cash of $10.8 million for operating activities for the year ended December 31, 2023.
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.
Net cash used in investing activities for 2023 was related to purchases of property and equipment. Net cash provided by investing activities for 2022 was related to the sale of property and equipment. Financing Activities Net cash used in financing activities was $80 thousand, compared to net cash provided by financing activities of $28.7 million for 2022.
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.
To date, we have not generated any revenue from product sales, collaborations with other companies, government grants or any other source, and do not expect to generate any revenue in the foreseeable future.
To date, we have not generated any revenue from product sales, collaborations with other companies, government grants or any other source, and do not expect to generate any revenue in the foreseeable future. Accumulated deficit We have an accumulated deficit, and we expect to continue to incur significant expenses and increasing operating losses for at least the next several years.
Specifically, the $6.4 million increase in R&D expenses was primarily attributable to (i) $6.3 million in higher expenditures for investigational drug manufacturing costs, non-clinical and preclinical services, clinical trials and consulting, (ii) $0.1 million in higher stock-based compensation, and (iii) $0.1 million in higher employee compensation and benefits.
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.
Net cash used in operating activities of $10.8 million for 2023 consisted of (i) net loss of $12.5 million and (ii) net non-cash income of $2.7 million, partially offset by net cash provided operating assets and liabilities of $4.4 million.
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.
There can be no assurance that we will be able to obtain any sources of financing on acceptable terms, or at all. To the extent that we can raise additional funds by issuing equity securities, our stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact our ability to conduct our business.
To the extent that we can raise additional funds by issuing equity securities or in the event our existing warrants are exercised, our stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact our ability to conduct our business.
Accordingly, we recorded a valuation allowance on the deferred tax assets attributable to the NOL we have incurred in each year or for our earned R&D credits.
Income taxes We have had significant pre-tax losses since our inception, and we have not yet generated revenues and face significant challenges to becoming profitable. Accordingly, we recorded a valuation allowance on the deferred tax assets attributable to the NOL we have incurred in each year or for our earned R&D credits.
Acquired in-process research and development expenses We had no acquired in-process research and development (“IPR&D”) expenses for 2023, compared to $8.2 million of acquired IPR&D expenses for 2022. We include costs to acquire or in-license product candidates in acquired IPR&D.
Acquired in-process research and development expenses We include costs to acquire or in-license product candidates in-process research and development (“IPR&D”).
General and administrative expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel in executive, finance and administrative functions. General and administrative expenses also include direct and allocated facility-related costs as well as professional fees for legal, patent, consulting, investor and public relations, accounting, and audit services.
G&A expenses also include direct and allocated facility-related costs as well as professional fees for legal, patent, consulting, investor and public relations, accounting, and audit services.
The most significant estimates in our consolidated financial statements relate to accrued expenses and the fair value of stock-based compensation and warrants. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities.
We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from those estimates. Changes in estimates are reflected in reported results in the period in which they become known.
Liquidity and capital resources Our primary use of cash is to fund our R&D activities and clinical development activities. We have funded our operations primarily through public offerings of our common stock and private placements of equity. As of December 31, 2023, we had cash totaling $22.4 million.
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.
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. Financing activities currently represent the principal source of our cash flow.
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.
Royalties owed on future sales of any licensed product will be expensed in the period the related revenues are recognized. General and administrative expenses Our general and administrative expenses were $6.7 million and $8.6 million for 2023 and 2022, respectively.
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.
Provision for income taxes Our effective tax rate for 2023 and 2022 was zero percent as we have recorded a full valuation allowance for the income tax benefits attributable to our pre-tax losses.
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.
This decrease was attributable to (i) $8.2 million in lower acquired IPR&D expenses and (ii) $1.9 million in lower general and administrative expenses, partially offset by $6.4 million in higher R&D expenses. Our R&D expenses were $9.2 million for 2023, an increase of $6.4 million, or 229.7%, compared to 2022.
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.
Our cash forecast for the 12-month period from the filing date of this Annual Report utilize current cash balance less estimated payments for future clinical trials and G&A costs plus forecasted cash inflows Recent accounting pronouncements Information regarding (i) adoption of new accounting standards during 2023 and (ii) accounting standards issued but not yet adopted is included in "Note 1.
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.
We believe that our existing cash will be sufficient to fund our operations into the fourth quarter of 2024. We plan to continue to fund our operations through a combination of equity offerings, debt financings, or other sources, potentially including collaborations, out-licensing and other similar arrangements.
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.
Business, basis of presentation, new accounting standards and summary of significant accounting policies " to the consolidated financial statements included in this Annual Report. ​
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 ​
We had state R&D credit carryforwards of $2 thousand as of December 31, 2023 and 2022, respectively. Our state NOL and R&D credit carryforwards will begin to expire in 2042, if not utilized.
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.
Net cash used in financing activities for 2023 was related to payment of certain issuance costs related to the 2022 Public Offering.
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.
This decrease was attributable to a decrease of $5.0 million in gain related to the change in fair value of warrant liabilities as compared to 2022. This decrease was partially offset by $0.5 million of interest income recorded in 2023, of which there was none in 2022, and $2.3 million of financing and other expenses incurred in 2022.
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.
The following table sets forth our contractual obligations under our operating lease as of December 31, 2023: ​ ​ ​ ​ ​ ​ Operating ​ ​ Lease 2024 ​ $ 86 2025 ​ ​ 89 2026 ​ ​ 60 Total lease payments ​ $ 235 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.
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.
The decreases were partially offset by an increase of $0.2 million in state non-income taxes and fees as well as public company costs. Other income Our other income for 2023 was $3.4 million, a decrease of $2.2 million, or 39.7%, compared to 2022.
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.
DA-1726 acts as a dual agonist of GLP1R and GCGR. Our operations have consisted principally of performing research and development (“R&D”) activities, clinical development and raising capital. Our activities are subject to significant risks and uncertainties, such as failing to secure additional funding before sustainable revenues and profit from operations are achieved.
Our activities are subject to significant risks and uncertainties, such as failing to secure additional funding before sustainable revenues and profit from operations are achieved. For more information on our business and product candidates, see Part I, Item 1. Business of this Annual Report.
Contractual obligations, purchase commitments and employment agreements Contractual obligations In August 2023, we entered into a non-cancelable operating lease for our new corporate headquarters in Cambridge, Massachusetts (the “Cambridge Headquarters Lease”). 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.
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.
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 and commercializing novel pharmaceuticals to treat cardiometabolic diseases. NeuroBo has two programs focused primarily on treatment of metabolic dysfunction-associated steatohepatitis (“MASH”) and obesity.
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.
This increase was primarily related to increased development activities for DA-1241 and DA-1726.
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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MASH was formerly known as non-alcoholic steatohepatitis (“NASH”).
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This discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties.
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The American Association for the Study of Liver Diseases (“AASLD”) and its European and Latin American counterparts changed the name to metabolic dysfunction-associated steatohepatitis to reflect the complexity of the disease. ● DA-1241 is a novel G-Protein-Coupled Receptor 119 (“GPR119”) agonist with development optionality as a standalone and/or combination therapy for both MASH and type 2 diabetes.
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With the activation of the dual agonist, weight loss may be achieved by GLP1R reducing appetite while GCGR increases energy expenditure.
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For more information on our business and product candidates, see Part I, Item 1. Business of this Annual Report. 62 ​ Table of Contents K ey operating information Research and development expenses Our R&D expenses were $9.2 million and $2.8 million for 2023 and 2022, respectively.
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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.
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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.
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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.
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Income taxes Our provision for income taxes was zero for 2023 and 2022. We have had significant pre-tax losses since our inception, and we have not yet generated revenues and face significant challenges to becoming profitable.
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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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We had U.S. federal R&D credit carryforwards of $24 thousand as of December 31, 2023 and 2022. Since our U.S. federal net operating losses were incurred after December 31, 2017, U.S NOL and R&D credit carryforwards will not expire. As of December 31, 2023 and 2022, we had state NOL carryforwards of $4.4 million and $0.9 million, respectively.
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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.
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Lastly, since the foreign subsidiary that generated the foreign losses 64 ​ Table of Contents was dissolved and liquidated in June 2023, the recorded value of foreign NOL and related deferred tax asset have been reduced to zero.
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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.
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Accordingly, we have no had foreign NOL carryforwards as of December 31, 2023 and $0.7 million of foreign NOL carryforwards as of December 31, 2022. Net loss We have incurred significant operating losses since our inception.
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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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Accumulated deficit As of December 31, 2023 and 2022, we had an accumulated deficit of $108.3 million and $95.8 million, respectively. We expect to continue to incur significant expenses and increasing operating losses for at least the next several years.
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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.
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Included in R&D expenses for 2023 was $2.4 million of investigational drug manufacturing costs, non-clinical and preclinical expenses incurred under the Shared Services Agreement with Dong-A as compared to none in 2022. We had no acquired IPR&D expenses for 2023, compared to $8.2 million for 2022.
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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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The 2022 acquired IPR&D expenses were attributable to the acquisition of intellectual property rights under the 2022 License Agreement.
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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”).
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Given that no processes or activities constituting a “business” were acquired and since none of the rights underlying the 2022 License Agreement had alternative future uses or had reached a stage of technological feasibility, the acquisition was recorded as acquired IPR&D expense and was based on the fair value of the 2,200 shares of Series A Preferred Stock issued to Dong-A pursuant to the terms and conditions of the 2022 License Agreement. 66 ​ Table of Contents Our general and administrative expenses were $6.7 million for 2023, a decrease of $1.9 million, or 22.1%, compared to 2022.
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The most significant estimates in our consolidated financial statements relate to clinical trial costs and accruals, classification of warrants as derivative liability or equity, and the fair value of stock-based compensation and warrants.
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This decrease in general and administrative expenses was primarily attributable to (i) $0.9 million in lower insurance cost, (ii) $0.7 million in lower stock-based compensation, (iii) $0.3 million in lower legal and professional fees, and (iv) $0.3 million in lower employee compensation and benefits.
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The change in fair value of warrant liabilities resulted in a gain of $3.0 million for 2023, compared to a gain of $7.9 million for 2022.
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This change was primarily a result of (i) a decrease in the number of outstanding warrants as of December 31, 2023 due to various cashless conversion of warrants to common stock during 2023 and (ii) the impact of our common stock’s lower underlying stock price since December 31, 2022.
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Interest income of $0.5 million for 2023 was primarily related to interest earned on our cash balance. We did not have any interest income for 2022.
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We did not incur any financing expenses for 2023, compared to $2.2 million of financing expenses for 2022, which represents the portion of the transaction costs allocated to the issuance of the Series A Warrants and Series B Warrants, described further below.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeItem 7A. Quantitative and Qualitative Disclosures About Market Risk We are exposed to market risks in the ordinary course of business. Some potential market risks are discussed below: 70 ​ Table of Contents Market risk Strategic and operational risks arise if we fail to carry out business operations and/or raise sufficient equity and/or debt financing.
Biggest changeItem 7A. Quantitative and Qualitative Disclosures About Market Risk We are exposed to market risks in the ordinary course of business. Some potential market risks are discussed below: Market risk Strategic and operational risks arise if we fail to carry out business operations and/or raise sufficient equity and/or debt financing.
These strategic opportunities or threats arise from a range of factors that might include changing economic and political circumstances and regulatory approvals and competitor actions. The risk is mitigated by consideration of other potential development opportunities and challenges which management may undertake. Currency risk Our operating results and financial position are reported in U.S. dollars.
These strategic opportunities or risks arise from a range of factors that might include changing economic and political circumstances and regulatory approvals and competitor actions. The risk is mitigated by consideration of other potential development opportunities and challenges which management may undertake. Currency risk Our operating results and financial position are reported in U.S. dollars.

Other MTVA 10-K year-over-year comparisons