MetaVia (MTVA) risk factors, FY2025 10-K

Risks related to our financial position and need for capital

1. 01As we do not generate any revenue, we are dependent on working capital to fund our business plan, and raising additional capital may cause dilution to existing stockholders, restrict our operations or require us to relinquish rights to our technologies
2. 02Future sales, or the perception of future sales, by us or our securityholders could cause the market price of our common stock to decline69% rewritten
3. 03additional shares of our common stock will be issued, which will result in dilution to the then existing holders of shares our common stock and increase the number of shares eligible for resale in the public marketNew
4. 04Adverse global economic conditions could have a material adverse effect on our business, results of operations and financial condition and liquidity
5. 05Changes in and uncertainty surrounding U.S. trade policy could have a material adverse impact on our business, financial condition and results of operationsNew
6. 06Conditions in the banking system and financial markets, including the failure of banks and financial institutions, could have an adverse effect on our operations and financial results39% rewritten
7. 07We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success
8. 08Public opinion and scrutiny of treatments for obesity, overweight patients, MASH and MASH patients may impact public perception of our Company, DA-1726, vanoglipel (DA-1241), or may adversely affect our ability to conduct our business and our business plans24% rewritten
9. 09We may be required to make significant payments under the 2022 License Agreement
10. 10Even if we obtain favorable clinical results, we may not be able to obtain regulatory approval for, or successfully commercialize vanoglipel (DA-1241) and DA-172629% rewritten
11. 11Preliminary, interim and topline data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
12. 12Results of earlier clinical trials may not be predictive of the results of later-stage clinical trials
13. 13Product candidates may cause undesirable side effects that could delay or prevent their marketing approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any, including marketing withdrawal
14. 14Our efforts to discover drug candidates beyond our current drug candidates may not succeed, and any drug candidates we recommend for clinical development may not actually begin clinical trials
15. 15Delays in our clinical trials may lead to a delay in the submission of marketing approval applications and jeopardize our ability to potentially receive approvals and generate revenues from the sale of our products
16. 16We may develop vanoglipel (DA-1241) and DA-1726, and potentially future product candidates, in combination with other therapies, which exposes us to additional risks
17. 17Any collaboration arrangement that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our current and potential future drug candidates
18. 18We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do
19. 19Even if we obtain regulatory approval for any of our product candidates that we may develop or acquire in the future, the product may not gain market acceptance among hospitals, physicians, health care payors, patients, and the medical communityNew
20. 20Even if we are able to commercialize a future pharmaceutical drug candidate, the profitability of such product candidate will likely depend in significant part on third-party reimbursement practices, which, if unfavorable, would harm our business
21. 21We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management
22. 22Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop
23. 23If we or our third-party manufacturers fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have an adverse effect on the success of our business
24. 24We rely and will continue to rely on collaborative partners regarding the development of our research programs and product candidates
25. 25If, in the future, we are unable to establish sales and marketing capabilities or to selectively enter into agreements with third parties to sell and market our product candidates, we may not be successful in commercializing our product candidates if and when they are approved
26. 26Any product candidate for which we obtain marketing approval could be subject to marketing restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products
27. 27We or any potential collaborator may never receive regulatory approval to market our product candidates outside of the U.S
28. 28Current 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
29. 29Governments outside the U.S. tend to impose strict price controls, which may adversely affect our revenues, if any
30. 30Our ability to use our net operating losses (“ NOLs”) to offset future taxable income may be subject to certain limitations35% rewritten
31. 31Tax matters, including the changes in corporate tax rates, disagreements with taxing authorities and imposition of new taxes could impact the results of our operations and financial condition81% rewritten
32. 32Federal legislation and actions by state and local governments may permit reimportation of drugs from foreign countries into the U.S., including foreign countries where the drugs are sold at lower prices than in the U.S., which could adversely affect our operating results

Risks related to dependence on third parties

1. 33We rely on third parties to manufacture our product candidates and preclinical and clinical drug supplies
2. 34We may engage in future acquisitions, mergers, in-licenses and out-licenses of technology that could disrupt our business, cause dilution to the organization’s stockholders and harm our financial condition and operating results
3. 35We may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements
4. 36Our employees, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business

Risks related to intellectual property

1. 37If we are unable to obtain and maintain sufficient intellectual property rights, our competitive position could be harmed
2. 38We may not be able to protect or practice our intellectual property rights throughout the world
3. 39We may become involved in lawsuits to protect or enforce our intellectual property rights, which could be expensive, time-consuming and unsuccessful
4. 40Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business
5. 41Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities
6. 42We 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
7. 43Our trade secrets are difficult to protect and if we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
8. 44Our ability to obtain and maintain our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
9. 45Intellectual property rights do not necessarily address all potential threats to our competitive advantage

Risks related to operations, employee matters and managing growth

1. 46We currently have a small number of employees and consultants, and our future success depends on our ability to retain our executive officers and to attract, retain and motivate qualified personnel
2. 47We may need to increase the size of our organization, and we may experience difficulties in managing this growth
3. 48We 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.S24% rewritten
4. 49The pharmaceutical industry is highly competitive and is subject to rapid and significant technological change, which could render our technologies and products obsolete or uncompetitive

Risks related to our common stock

1. 50The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for holders of our common stock
2. 51Our two largest stockholders may use their significant interest to take actions not supported by our other stockholdersNew
3. 52Provisions 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
4. 53Nasdaq has proposed enhanced listing standards, which could adversely affect our ability to maintain our Nasdaq listing and access to capital marketsNew
5. 54We are a “smaller reporting company” and we cannot be certain if the reduced reporting requirements applicable to such companies could make our common stock less attractive to investors64% rewritten
6. 55required 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 statementsNew
7. 56Our business and operations may suffer in the event of system failures or other unplanned events79% rewritten
8. 57An active trading market for our common stock may not be maintained
9. 58If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our business, the price of our stock could decline
10. 59We incur increased costs as a result of operating as a public company and our management is required to devote substantial time to compliance initiatives
11. 60We 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