▸ GTx-101, through either out-licensing or sale.· · · · ● 1 ▸ IPR&D asset and the GTx-101 IPR&D asset are no longer recoverable on an· · · · ● 1 ▸ The One Big Beautiful Bill Act, signed into law on July 4, 2025, is projected to decrease federal health care spending by approximately $1 trillion by reducing Medicaid spending and enrollment and making changes to federal Medicare spending.· · · · ● 1 ▸ We face risks related to the growth of artificial intelligence and data analytics.· · · · ● 1 ▸ Even if GTx-104 receives regulatory approval, we will still face regulatory difficulties.· · · ● ● 2 ▸ If a product candidate causes undesirable side effects, then we may be unable to receive regulatory approval or market acceptance for such product candidate.· · · ● ● 2 ▸ If the market opportunities for GTx-104 are smaller than we believe they are, our results of operations may be adversely affected, and our business may suffer.· · · ● ● 2 ▸ The occurrence of any event or penalty described above may inhibit or preclude our ability to commercialize GTx-104 and generate revenue.· · · ● ● 2 ▸ We face risks related to the personal data we collect, process, and share.· · · ● ● 2 ▸ We have no history of commercializing drugs, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.· · · ● ● 2 ▸ There is a significant risk that we may have been classified as a PFIC for U.S. federal income tax purposes and that such PFIC status may taint our common shares owned by U.S. Holders prior to the Domestication.· · · ● · 1 ▸ We may not be able to maximize value from our de-prioritized drug candidates, GTx-102 and GTx-101, through either development, out-licensing or sale.· ● ● ● · 3 ▸ Any of these events could prevent us from achieving or maintaining market acceptance of the affected drug product or drug candidate and could substantially increase the costs of commercializing our drug products and drug candidates.● ● · · · 2 ▸ As a non-accelerated filer, we are not required to comply with the auditor attestation requirements of the Sarbanes-Oxley Act.● · · · · 1 ▸ At March 31, 2024, Acasti Pharma U.S. had net operating loss carry forwards (“NOLs”) for U.S. federal income tax purposes of approximately $15.4 million, which have no expiry.● ● ● · · 3 rw ▸ Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.● ● ● · · 3 ▸ Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect any of our other future drug candidates.● ● · · · 2 ▸ group General Risks Related to the Company● ● · · · 2 ▸ Guidelines and recommendations published by government agencies can reduce the use of our drug candidates and drug products, if approved and negatively impact our ability to gain market acceptance and market share.● ● · · · 2 ▸ If our estimates or judgments relating to our critical accounting policies for intangible assets prove to be incorrect, further impairment charges could result.● ● ● ● · 4 rw ▸ If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our share price and trading volume could decline.● ● · · · 2 ▸ If we fail to meet applicable listing requirements, Nasdaq may delist our common shares from trading, in which case the liquidity and market price of our common shares could decline.● ● ● · · 3 rw ▸ Lawsuits have been filed, and other lawsuits may be filed, against us and members of our board of directors challenging the Grace merger, and an adverse ruling in any such lawsuit may result in an award of damages against us.● · · · · 1 ▸ Our contract manufacturers may encounter manufacturing failures that could delay the clinical development or regulatory approval of our drug candidates, or their commercial production, if approved.● ● ● · · 3 ▸ Our future results will suffer if we do not effectively manage our expanded operations.● · · · · 1 ▸ Our success depends in part upon our ability to protect our intellectual property for our branded drug products and drug candidates.● ● · · · 2 rw ▸ group Risks Factors Relating to our Business● ● ● ● · 4 rw ▸ The IRS may not agree that we should be treated as a foreign corporation for U.S. federal tax purposes prior to the Domestication.● ● ● ● · 4 rw ▸ The design, development, manufacture, supply, and distribution of our drug candidates is highly regulated and technically complex.● ● · · · 2 ▸ The market price of our common shares could decline if our operating results fall below the expectations of investors or fluctuate.● ● · · · 2 ▸ TheCOVID-19pandemic, or a similar pandemic, epidemic, or outbreak of an infectious disease, may materially and adversely affect our business and our financial results and could cause a disruption to the development of our drug candidates.● ● · · · 2 ▸ There can be no assurance that an active market for our common shares will be sustained.● ● · · · 2 ▸ There is a significant risk that we may be classified as a PFIC for U.S. federal income tax purposes.● ● ● · · 3 ▸ We are a Québec incorporated company, and U.S. investors may be unable to enforce certain judgments against us.● ● ● · · 3 rw ▸ We are subject to numerous complex regulatory requirements and failure to comply with these regulations, or the cost of compliance with these regulations, may harm our business.● ● ● ● · 4 ▸ We do not have internal manufacturing capabilities, and if we fail to develop and maintain supply relationships with various third-party manufacturers, we may be unable to develop or commercialize our drug candidates.● ● · · · 2 ▸ We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties.● ● · · · 2 ▸ We may be subject to foreign exchange rate fluctuations.● ● · · · 2 ▸ We may not be able to use our net operating loss carry forwards to offset future taxable income for Canadian or U.S. federal income tax purposes.● ● ● · · 3 ▸ We may not be successful in establishing development and commercialization collaborations which could adversely affect, and potentially prohibit, our ability to develop our drug candidates.● ● · · · 2 ▸ We may pursue opportunities or transactions that adversely affect our business and financial condition.● ● ● · · 3 ▸ We rely on information technology and any failure, inadequacy, interruption, or security lapse of that technology, including any cybersecurity incidents, could harm our ability to operate our business effectively.● ● ● ● · 4 rw ▸ Even if our drug candidates receive regulatory approval in the United States, we may never obtain regulatory approval or successfully commercialize our products outside of the United States.● ● ● ● ● 5 ▸ 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 would have a material adverse effect on our business.● ● ● ● ● 5 ▸ If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our drug candidates, we may be unable to generate any revenue.● ● ● ● ● 5 ▸ If we obtain approval to commercialize any approved drug products outside of the United States, a variety of risks associated with international operations could materially adversely affect our business.● ● ● ● ● 5 ▸ Intellectual property rights do not necessarily address all potential threats to our competitive advantage.● ● ● ● ● 5 ▸ Our commercial success depends upon attaining significant market acceptance of our drug candidates and drug products, if approved, among physicians, nurses, pharmacists, patients, the medical community and third-party payors.● ● ● ● ● 5 rw ▸ Our employees, independent contractors, principal investigators, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.● ● ● ● ● 5 ▸ Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.● ● ● ● ● 5 ▸ Our success depends in part upon our ability to protect our intellectual property for our branded products and drug candidates.● ● ● ● ● 5 rw ▸ Raising additional capital may cause dilution to our existing stockholders, restrict our operations, or require us to relinquish rights to our technologies or drug candidates.● ● ● ● ● 5 rw ▸ Risks Related to Development, Testing and Commercialization of Our Products● ● ● ● ● 5 ▸ group Risks Related to Our Dependence on Third Parties● ● ● ● ● 5 ▸ group Risks Relating to Our Common Stock● ● ● ● ● 5 rw ▸ group Risks Relating to Our Intellectual Property● ● ● ● ● 5 ▸ Should any of these events occur, they could significantly harm our business, results of operations and prospects.● ● ● ● ● 5 ▸ The price of our common stock may be volatile.● ● ● ● ● 5 rw ▸ We are heavily dependent on the success of our lead drug candidate, GTx-104.● ● ● ● ● 5 rw ▸ We are required to obtain regulatory approval for each of our drug candidates in each jurisdiction in which we intend to market such products, and the inability to obtain such approvals would limit our ability to realize their full market potential.● ● ● ● ● 5 ▸ We are subject to uncertainty relating to healthcare reform measures and reimbursement policies which, if not favorable to our drug candidates, could hinder or prevent our drug candidates’ commercial success.● ● ● ● ● 5 ▸ We could incur substantial costs and disruption to our business and delays in the launch of our drug candidates if our competitors and/or collaborators bring legal actions against us, which could harm our business and operating results.● ● ● ● ● 5 ▸ We do not expect to pay any cash dividends for the foreseeable future.● ● ● ● ● 5 ▸ We face potential product liability, and if claims are brought against us, we may incur substantial liability.● ● ● ● ● 5 ▸ We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.● ● ● ● ● 5 ▸ We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.● ● ● ● ● 5 ▸ We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed alleged confidential information or trade secrets of their other clients or former employers to us.● ● ● ● ● 5 ▸ We may need to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations and our ability to compete.● ● ● ● ● 5 rw ▸ We may not achieve our publicly announced milestones on time, or at all.● ● ● ● ● 5 ▸ We may not be able to maintain our operations and advance our research and development and if approved, commercialization of our GTx-104 lead drug candidate without additional funding.● ● ● ● ● 5 rw ▸ We may not be able to protect our intellectual property rights throughout the world.● ● ● ● ● 5 
