▸ Our industry is subject to extensive regulatory obligations and policies that may be subject to change, including due to judicial challenges.· · · ● 1 ▸ The complexity and uncertainty of European laws have increased in recent years.· · · ● 1 ▸ We have completed enrollment of our first Phase 3 clinical trials for XYNGARITM, but that does not guarantee successful completion.We may be unable to successfully complete it or any future clinical trials.· · · ● 1 ▸ Approval may be delayed or denied because we cannot satisfy FDA’s Chemistry, Manufacturing and Control Requirements.· · ● ● 2 ▸ We are exposed to risks related to foreign currency exchange rates.· · ● ● 2 ▸ We face risks related to health epidemics and outbreaks, including COVID-19, which could significantly disrupt our preclinical studies and clinical trials.· ● · · 1 ▸ A pandemic, epidemic, or outbreak of an infectious disease, such as COVID-19 could cause a disruption to the development of our product candidates.● · · · 1 ▸ Our ability to attract and retain qualified members of our Board may be impacted due to new state laws, including recently enacted gender and diversity quotas.● ● ● · 3 rw ▸ Our business involves the use of hazardous materials and we and our third-party suppliers and manufacturers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.● ● ● · 3 ▸ Our directors, executive officers and principal stockholders have substantial control over us and could delay or prevent a change of corporate control.● ● · · 2 ▸ Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.● ● ● · 3 ▸ See “Principal Stockholders” below for more information regarding the ownership of our outstanding stock by our executive officers, directors and holders of more than 5% of our common stock, together with their affiliates.● ● · · 2 ▸ We have initiated our first Phase 3 clinical trials for DMT310 and may be unable to successfully complete it or any future clinical trials.● ● ● · 3 rw ▸ A Warrant does not entitle the holder to any rights as common stockholders until the holder exercises the Warrant for a share of our common stock.● ● ● ● 4 ▸ Adverse global conditions, including economic uncertainty, may negatively impact our financial results.● ● ● ● 4 ▸ Anti-takeover provisions contained in our certificate of incorporation and bylaws, as well as provisions of Delaware law, could impair a takeover attempt.● ● ● ● 4 ▸ Any product candidates that we commercialize, or that any partner with which we may collaborate commercializes, will be subject to ongoing and continued regulatory review.● ● ● ● 4 ▸ Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.● ● ● ● 4 ▸ Changes in tax laws may materially adversely affect our business financial condition, results of operations and cash flows.● ● ● ● 4 ▸ Disruptions in the global economy and supply chains may have a material adverse effect on our business, financial condition and results of operations.● ● ● ● 4 ▸ Even if our current product candidates or any future product candidates obtain regulatory approval, they may fail to achieve the broad degree of physician and patient adoption and use necessary for commercial success.● ● ● ● 4 ▸ Future sales of our common stock, Warrants or securities convertible into our common stock may depress our stock price.● ● ● ● 4 ▸ Global conditions, dislocations in the financial markets, any negative financial impacts affecting United States as a result of tax reform or changes to existing trade agreements or tax conventions, may adversely impact our business.● ● ● ● 4 ▸ Healthcare legislative or regulatory reform measures, including government restrictions on pricing and reimbursement, may have a negative impact on our business and results of operations.● ● ● ● 4 ▸ If our patent term expires before or soon after our products are approved, or if manufacturers of generic or biosimilar drugs successfully challenge our patents, our business may be materially harmed.● ● ● ● 4 ▸ If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.● ● ● ● 4 ▸ If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.● ● ● ● 4 ▸ If we are not able to establish and maintain collaborations, we may have to alter our development and commercialization plans.● ● ● ● 4 ▸ If we are sued for infringing intellectual property rights of third parties, it will be costly and time-consuming, and an unfavorable outcome in that litigation could have a material adverse effect on our business.● ● ● ● 4 ▸ If we cannot successfully execute any one of the foregoing, our business may fail and your investment will be adversely affected.● ● ● ● 4 ▸ If we fail to attract and retain management and other key personnel, we may be unable to continue to successfully develop or commercialize our product candidates or otherwise implement our business plan.● ● ● ● 4 ▸ If we fail to comply with our obligations under our intellectual property license agreements, we could lose license rights that are important to our business.● ● ● ● 4 ▸ Other examples of proposed changes include, but are not limited to, expanding post-approval requirements, changing the Orphan Drug Act, and restricting sales and promotional activities for pharmaceutical products.● ● ● ● 4 ▸ Our Warrants may not have any value.● ● ● ● 4 ▸ Our ability to use our net operating loss carryforwards may be limited.● ● ● ● 4 rw ▸ Our business and operations would suffer in the event of failures in our internal computer systems.● ● ● ● 4 ▸ Our business is dependent on the successful development, regulatory approval and commercialization of our product candidates, in particular XYNGARITM and DMT410.● ● ● ● 4 rw ▸ Our business may be affected by new sanctions, import restrictions, and export controls targeting Russia and other responses to Russia’s invasion of Ukraine.● ● ● ● 4 rw ▸ Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our common stock● ● ● ● 4 rw ▸ Our failure to successfully in-license, acquire, develop, and market additional product candidates or approved products would impair our ability to grow our business.● ● ● ● 4 rw ▸ Our future growth depends, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.● ● ● ● 4 ▸ Our operating results and liquidity needs could be negatively affected by market fluctuations and economic downturn.● ● ● ● 4 ▸ Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations.● ● ● ● 4 ▸ Our product candidates may cause undesirable side effects or have other unexpected properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in post-approval regulatory action.● ● ● ● 4 ▸ Our product candidates, if approved, will face significant competition and our failure to effectively compete may prevent us from achieving significant market penetration.● ● ● ● 4 ▸ Our proprietary information may be lost, or we may suffer security breaches.● ● ● ● 4 ▸ Our reliance on contract manufacturers and suppliers further exposes us to the possibility that they, or third parties with access to their facilities, will have access to and may misappropriate our trade secrets or other proprietary information.● ● ● ● 4 ▸ Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our future patents.● ● ● ● 4 ▸ Risks Related to Development, Regulatory Approval and Commercialization● ● ● ● 4 ▸ group Risks Related to Managing Our Growth, Our Employees and Our Operations● ● ● ● 4 ▸ group Risks Related to Our Dependence on Third Parties● ● ● ● 4 ▸ group Risks Related to Our Financial Position and Need for Capital● ● ● ● 4 ▸ group Risks Related to Our Intellectual Property● ● ● ● 4 ▸ Risks Related to the Securities Markets and Ownership of Our Common Stock and Warrants● ● ● ● 4 ▸ group Summary of Risks Associated with Our Business● ● ● ● 4 ▸ The market price of our common stock and Warrants have been volatile and can fluctuate substantially, which could result in substantial losses for holders of our securities.● ● ● ● 4 ▸ The occurrence of any of the foregoing could adversely affect our business, financial condition, or operating results.● ● ● ● 4 rw ▸ The reports of our independent registered public accounting firm for the fiscal years ended December 31, 2024 and 2023 contain an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.● ● ● ● 4 rw ▸ These provisions, alone or together, could delay or prevent hostile takeovers and changes in control or changes in our management.● ● ● ● 4 ▸ We are a clinical stage pharmaceutical company with a limited operating history.● ● ● ● 4 ▸ We are an “emerging growth company,” and will be able take advantage of reduced disclosure requirements applicable to “emerging growth companies,” which could make our common stock and Warrants less attractive to investors.● ● ● ● 4 ▸ We are increasingly dependent on information technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.● ● ● ● 4 ▸ We expect to face generic or similar type of product competition for our product candidates, which could adversely affect our business, financial condition, operating results and prospects.● ● ● ● 4 ▸ We have never paid dividends on our capital stock, and we do not anticipate paying any cash dividends in the foreseeable future.● ● ● ● 4 ▸ We intend to seek NCE exclusivity for XYNGARITMand future product candidates, and we may be unsuccessful in obtaining such exclusivity.● ● ● ● 4 rw ▸ We may also be subject to healthcare laws, regulation and enforcement and our failure to comply with those laws could adversely affect our business, operations and financial condition.● ● ● ● 4 ▸ We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed to us alleged trade secrets of their former employers or their former or current customers.● ● ● ● 4 rw ▸ We may become involved in lawsuits to protect or enforce our patents or other intellectual property or the patents of our licensors, which could be expensive and time-consuming.● ● ● ● 4 ▸ We may choose not to continue developing or commercializing any of our product candidates at any time during development or after approval, which would reduce or eliminate our potential return on investment for those product candidates.● ● ● ● 4 ▸ We may face product liability exposure, and if successful claims are brought against us, we may incur substantial liability if our insurance coverage for those claims is inadequate.● ● ● ● 4 ▸ We may in the future conduct clinical trials for our product candidates outside the United States and the FDA and applicable foreign regulatory authorities may not accept data from such trials.● ● ● ● 4 ▸ We may not be able to obtain or enforce patent rights or other intellectual property rights that cover our product candidates and technologies that are of sufficient breadth to prevent third parties from competing against us.● ● ● ● 4 ▸ We may not be able to protect our intellectual property rights throughout the world.● ● ● ● 4 ▸ We or our current and prospective partners may be subject to product recalls in the future that could harm our brand and reputation and could negatively affect our business.● ● ● ● 4 ▸ We will need to further increase the size and complexity of our organization in the future, and we may experience difficulties in executing our growth strategy and managing any growth.● ● ● ● 4 ▸ We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of our product candidates.● ● ● ● 4 rw 
