▸ Certain of our programs may compete with our other programs, which could negatively impact our business and reduce our future revenue.· · · ● 1 ▸ Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.· · · ● 1 ▸ Conflicts of interest may arise between us and Paragon or us and Fairmount.· · · ● 1 ▸ Fairmount beneficially owns more than 5% of the Company’s capital, currently has two representatives appointed to the Board and beneficially owns more than 5% of Paragon.· · · ● 1 ▸ Future sales of shares by existing stockholders could cause our stock price to decline.· · · ● 1 ▸ Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any.· · · ● 1 ▸ If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, then our stock price and trading volume could decline.· · · ● 1 ▸ If we are unable to obtain or maintain necessary rights to our programs through acquisitions and in-licenses, our business may be materially harmed.· · · ● 1 ▸ If we 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 a material adverse effect on the success of our business.· · · ● 1 ▸ If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.· · · ● 1 ▸ In order to successfully implement our plans and strategies, we will need to grow the size of our organization, and we may experience difficulties in managing this growth.· · · ● 1 ▸ Litigation costs and the outcome of litigation could have a material adverse effect on our business.· · · ● 1 ▸ Our ability to use net operating loss (“NOL”) carryforwards and other tax attributes may be limited, including as a result of our recent merger.· · · ● 1 ▸ Our approach to the discovery and development of our product candidates is unproven, and we may not be successful in our efforts to build a pipeline of product candidates with commercial value.· · · ● 1 ▸ Our business may be affected by the evolving regulatory framework for AI Technologies.· · · ● 1 ▸ Our estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all.· · · ● 1 ▸ Our executive officers, directors and principal stockholders have the ability to control or significantly influence all matters submitted to our stockholders for approval.· · · ● 1 ▸ Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.· · · ● 1 ▸ Our future success is substantially dependent on our ability to timely obtain regulatory approval for, and then successfully commercialize, JADE101. We are initially investing a majority of our efforts and financial resources into the research and· · · ● 1 ▸ Our product candidates for which we intend to seek approval as biologics may face competition from biosimilars sooner than anticipated.· · · ● 1 ▸ Our reliance on foreign CROs and CMOs may increase the risks associated with our development programs.· · · ● 1 ▸ Our success will depend in part on our and our current and future licensors’ ability to obtain, maintain and enforce patent protection for our licensed intellectual property.· · · ● 1 ▸ Our technology licensed from various third parties may be subject to retained rights.· · · ● 1 ▸ Patent terms may be inadequate to protect our competitive position of our product candidates for an adequate amount of time.· · · ● 1 ▸ Preliminary, “topline” or interim data from our clinical trials that we announce or publish from time to time may change as more participant data become available and are subject to audit and verification procedures.· · · ● 1 ▸ Preliminary, “topline” or interim 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.· · · ● 1 ▸ group Risks Related to Our Business and Operations· · · ● 1 ▸ Risks associated with the in-licensing or acquisition of product candidates could cause substantial delays in the preclinical and clinical development of our product candidates.· · · ● 1 ▸ The class structure of our capital stock may limit your ability to influence corporate matters and may limit your visibility with respect to certain transactions.· · · ● 1 ▸ The market price of our common stock has been and is expected to continue to be volatile.· · · ● 1 ▸ We are an “emerging growth company” and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make our common stock less attractive to investors.· · · ● 1 ▸ We are governed by Nevada law and our articles of incorporation and bylaws, provisions of which have anti-takeover implications.· · · ● 1 ▸ We are substantially dependent on the success of JADE101, and our current and anticipated future clinical trials of such product candidate may not be successful.· · · ● 1 ▸ We do not anticipate that we will pay any cash dividends in the foreseeable future.· · · ● 1 ▸ We face competition from entities that have developed or may develop products for the diseases addressed by our product candidates.· · · ● 1 ▸ We may acquire businesses, product candidates or products, or form strategic alliances, in the future, and may not realize the benefits of such acquisitions or alliances.· · · ● 1 ▸ We may be subject to adverse legislative or regulatory tax changes that could negatively impact our financial condition.· · · ● 1 ▸ We may be subject to intellectual property lawsuits or may need to file lawsuits to protect our intellectual property, which could result in substantial costs and liability and prevent us from commercializing our potential products.· · · ● 1 ▸ We may become exposed to costly and damaging liability claims, when testing a product candidate in the clinical stage or at the commercial stage, and our product liability insurance may not cover all damages from such claims.· · · ● 1 ▸ We may expend our limited resources to pursue a particular program and fail to capitalize on programs that may be more profitable or for which there is a greater likelihood of success.· · · ● 1 ▸ We may face difficulties from healthcare and regulatory legislative reform measures.· · · ● 1 ▸ We may not be able to meet requirements for the chemistry, manufacturing and control of our product candidates.· · · ● 1 ▸ We may not be successful in our ongoing development and maintenance of these technologies in the face of novel and evolving technical, reputational and market factors.· · · ● 1 ▸ We plan to conduct clinical trials for product candidates at sites outside the United States, and the FDA may not accept data from trials conducted in such locations.· · · ● 1 ▸ We will incur additional costs and increased demands upon management as a result of complying with the laws and regulations affecting public companies.· · · ● 1 ▸ Any of the foregoing risks could have a material adverse effect on our business, financial condition and prospects.· · ● · 1 ▸ Certain provisions of the Merger Agreement may discourage third parties from submitting competing proposals, including proposals that may be superior to the transactions contemplated by the Merger Agreement.· · ● · 1 ▸ Even if FDA approval is obtained in the United States, it does not guarantee approval for or successful commercialization of a product candidate outside of the United States, which would limit the ability to realize its full market potential.· · ● · 1 ▸ Failure to complete the Merger may result in either Jade or us paying a termination fee to the other party, and could harm our common stock price and future business and operations of each company.· · ● · 1 ▸ If the Merger is not completed, our stock price may decline significantly.· · ● · 1 ▸ If the conditions to the Merger are not satisfied or waived, the Merger may not occur.· · ● · 1 ▸ If we are successful in completing the Merger, we may be exposed to other operational and financial risks.· · ● · 1 ▸ Lawsuits may be filed against us, Jade, or any of the members of our or Jade’s boards of directors arising out of the Merger, which may delay or prevent the Merger.· · ● · 1 ▸ Our ability to consummate the Merger depends on our ability to retain the employees required to consummate such transaction.· · ● · 1 ▸ Our cash preservation activities, including the Workforce Reduction Plan, may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business.· · ● · 1 ▸ group Risks Related to the Merger· · ● · 1 ▸ group Risks Related to the Research and Development Activities· · ● · 1 ▸ Some of Jade’s and our directors and executive officers have interests in the Merger that are different from our other stockholders.· · ● · 1 ▸ The Merger may be completed even though a material adverse effect may result from the announcement of the Merger, industry-wide changes or other causes.· · ● · 1 ▸ The results of earlier studies and trials may not be predictive of future trial results.· · ● · 1 ▸ We and Jade may mutually agree to waive the condition to the Merger requiring approval for listing on Nasdaq, and if such condition is waived, the combined company’s stock may not be listed on Nasdaq following completion of the Merger.· · ● · 1 ▸ We are subject to or affected by numerous federal, state and foreign laws and regulations, as well as regulatory guidance, governing the collection, use, disclosure, retention, and security of personal information, such as information that we· · ● · 1 ▸ We may become involved in litigation, including securities class action litigation, that could divert management’s attention and harm our business, and insurance coverage may not be sufficient to cover all costs and damages.· · ● · 1 ▸ We may not be successful in consummating the Merger.· · ● · 1 ▸ We may not pay any cash dividends on our capital stock in the foreseeable future, other than the Cash Dividend in connection with the Merger, and capital appreciation, if any, will be our stockholders’ sole source of gain.· · ● · 1 ▸ Any delay in obtaining, or inability to obtain, applicable regulatory approval would delay or prevent commercialization of AV-101 and would materially adversely impact our business and prospects.· ● · · 1 ▸ Changes in tax law may adversely affect us or our investors.· ● ● · 2 ▸ Our inability to obtain and maintain sufficient product liability insurance at an acceptable cost and scope of coverage to protect against potential product liability claims could prevent or inhibit the commercialization of AV-101. We currently· ● · · 1 ▸ Our success depends in part on our continued ability to attract, retain and motivate highly qualified management, clinical and scientific personnel. We are highly dependent upon our senior management, as well as other members of our· ● · · 1 ▸ Principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and may receive cash or equity compensation in connection with such services. If these relationships and any related· ● · · 1 ▸ Should any of these events occur, they could significantly harm our business, results of operations and prospects.· ● · · 1 ▸ We may become involved in opposition, interference, derivation, inter partes review or other proceedings challenging our patent rights, and the outcome of any proceedings are highly uncertain. An adverse determination in any such proceeding· ● · · 1 ▸ We may seek a breakthrough therapy designation for AV-101 for treatment of PAH. A breakthrough therapy is defined as a drug or biologic that is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or· ● · · 1 ▸ A fast track designation by the FDA, even if granted for AV-101, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval.● ● · · 2 ▸ AV-101 is a drug-device combination product, which may result in additional regulatory risks.● ● · · 2 ▸ Actual or perceived failures to comply with United States and foreign privacy and data protection laws, regulations and standards may adversely affect our business, operations and financial performance.● ● ● · 3 ▸ Although we work to comply with applicable laws, regulations and standards, our contractual obligations and other legal obligations, because the interpretation and application of many privacy and data protection laws (including the GDPR),● · · · 1 ▸ Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors, which may adversely affect our future profitability.● ● · · 2 ▸ Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.● ● ● · 3 ▸ Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.● ● · · 2 ▸ Changes in patent law could diminish the value of patents in general, thereby impairing the ability to protect product candidates.● ● ● · 3 rw ▸ Clinical development involves a lengthy and expensive process with an uncertain outcome, and delays can occur for a variety of reasons outside of our control.● ● · · 2 ▸ Comprehensive tax reform legislation could adversely affect our business and financial condition.● · · · 1 ▸ Enrollment risks are heightened with respect to indications that are rare or orphan diseases, which may limit the pool of patients that may be enrolled in our clinical trials. We are developing AV-101 for the treatment of PAH, which is an orphan● · · · 1 ▸ Even if AV-101 obtains regulatory approval, it may fail to achieve market acceptance.● ● · · 2 ▸ Even if we obtain FDA approval for AV-101 in the United States, we may never obtain approval for or successfully commercialize AV-101 outside of the United States, which would limit our ability to realize its full market potential.● ● · · 2 ▸ Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.● ● ● · 3 ▸ If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of AV-101.● ● · · 2 ▸ If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline.● ● ● · 3 ▸ If the FDA or comparable regulatory authorities approve generic versions of AV-101, or do not grant AV-101 a sufficient period of market exclusivity before approving its generic version, our ability to generate revenue may be adversely affected.● ● · · 2 ▸ If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.● ● ● · 3 ▸ If we do not obtain additional protection under the Hatch-Waxman Amendments and similar foreign legislation cannot be obtained to extend the patent protection for a product candidate, business operations may be materially harmed.● ● ● · 3 rw ▸ If we fail to establish and maintain proper and effective internal control over financial reporting, our operating results and our ability to operate our business could be harmed.● ● ● · 3 ▸ If we lose or cannot obtain additional patent protection for our AV-101 product candidate or other future product candidates it could have a material adverse impact on our business.● ● · · 2 ▸ Intellectual property litigation could cause us to spend substantial resources and prevent us from pursuing our programs.● ● ● · 3 ▸ Intellectual property rights do not necessarily address all potential threats to our competitive advantage.● ● · · 2 ▸ Of the large number of pharmaceutical products in development, only a small percentage successfully complete the FDA or other regulatory bodies’ approval processes and are commercialized.● ● ● · 3 ▸ Once a NDA is approved, including under the 505(b)(2) pathway, the product covered thereby becomes a “reference listed drug” in the FDA’s publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known● · · · 1 ▸ Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.● ● ● · 3 ▸ Our business is affected by macroeconomic conditions, including rising inflation, interest rates and supply chain constraints.● ● ● · 3 ▸ Our business is entirely dependent on the successful development, regulatory approval and commercialization of AV-101, our only product candidate under development.● ● · · 2 ▸ Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.● ● ● · 3 ▸ Our insurance policies may be inadequate and potentially expose us to unrecoverable risks.● ● ● · 3 ▸ Recent court rulings, including rules from the United States Supreme Court, have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing● · · · 1 ▸ group Risks Related to Employee Matters● ● ● · 3 rw ▸ group Risks Related to the Development of AV-101● ● · · 2 ▸ Should we in the future conduct clinical trials outside the United States, and the FDA, EMA and applicable foreign regulatory authorities may not accept data from such trials.● ● ● · 3 rw ▸ Third parties may initiate or threaten 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.● ● ● · 3 ▸ Unfavorable global economic or political conditions could adversely affect our business, financial condition or results of operations.● ● ● · 3 ▸ We are a biopharmaceutical company with a limited operating history.● ● ● · 3 rw ▸ We have experienced and may in the future encounter difficulties with site activation and patient enrollment in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.● ● · · 2 ▸ We have no products approved for commercial sale and have not generated any revenue from product sales.● ● ● · 3 ▸ We incur increased costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives.● ● ● · 3 ▸ We may be subject to securities litigation, which is expensive and could divert management attention.● ● · · 2 ▸ We may be unable to successfully implement these tasks, which could have a material adverse effect on our business, results of operations, financial condition, prospects and stock price.● ● · · 2 ▸ We may seek priority review designation for AV-101, but we might not receive such designation, and even if we do, such designation may not lead to a faster regulatory review or approval process.● ● · · 2 ▸ We may seek to establish collaborations, and, if we are not able to establish them on commercially reasonable terms, or at all, we may have to alter our development and commercialization plans.● ● · · 2 ▸ We rely on third parties to supply the raw materials to produce AV-101.● ● · · 2 ▸ We will need to increase the size of our organization, and we may experience difficulties in managing growth.● ● · · 2 ▸ We will not seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.● ● · · 2 ▸ group Risks Related to Our Discovery, Development and Commercialization● ● · ● 3 rw ▸ group Risks Related to Our Reliance on Third Parties● ● · ● 3 ▸ The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.● ● · ● 3 ▸ Lastly, if our trademarks and trade names are not registered or 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 rw ▸ group Risks Related to Government Regulation● ● ● ● 4 ▸ group Risks Related to Our Intellectual Property● ● ● ● 4 ▸ Risks Related to Our Limited Operating History, Financial Position and Capital Requirements● ● ● ● 4 rw ▸ group Risks Related to the Ownership of Our Common Stock● ● ● ● 4 rw ▸ We may be subject to claims that we have wrongfully hired an employee from a competitor or that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.● ● ● ● 4 rw ▸ We may become subject to claims challenging the inventorship or ownership of our patents, if issued, and other intellectual property.● ● ● ● 4 rw ▸ We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products.● ● ● ● 4 rw 
