▸ Delaware law also imposes some restrictions on mergers and other business combinations between us and any holder of 15% or more of our outstanding common stock.· · · ● 1 ▸ Our common stock may be delisted if we fail to comply with continued listing standards.· · ● ● 2 ▸ Healthcare reform measures and other recent legislative initiatives could adversely affect our business.· ● ● ● 3 ▸ group Risks Related to Government Regulation· ● ● ● 3 ▸ Our product candidate may not prove to be safe and efficacious in clinical trials and may not meet all the applicable regulatory requirements needed to receive regulatory approval. In order to receive regulatory approval for the· · ● · 1 ▸ We face competition generally from established pharmaceutical and biotechnology companies, as well as from academic institutions, government agencies and private and public research institutions. Many of our competitors have· · ● · 1 ▸ Throughout the drug development process, we must continually demonstrate the safety and tolerability of our product candidate to obtain regulatory approval to further advance clinical development or to market them. Even if our product· ● · · 1 ▸ We expect that the ACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and lower reimbursement, and in additional downward pressure on the price that we receive for· ● · · 1 ▸ A pandemic, epidemic or outbreak of an infectious disease, such as COVID-19, may materially and adversely affect our business and operations.● · · · 1 ▸ Healthcare reform measures could hinder or prevent our product candidate’s commercial success.● · · · 1 ▸ Our success depends in part on our continued ability to attract, retain and motivate highly qualified management, clinical and scientific personnel and on our ability to develop and maintain important relationships with● · · · 1 ▸ AI-POWRTM may fail to help us discover and/or develop additional potential product candidates.● ● ● ● 4 ▸ Business disruptions could seriously harm future revenue and financial condition and increase our costs and expenses.● ● ● ● 4 ▸ Certain provisions in our certificate of incorporation and by-laws, and of Delaware law, may prevent or delay an acquisition of our company, which could decrease the trading price of our common stock.● ● ● ● 4 ▸ Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.● ● ● ● 4 ▸ Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information and may not adequately protect our intellectual property.● ● ● ● 4 ▸ Delays in clinical testing could result in increased costs to us and delay our ability to generate revenue.● ● ● ● 4 ▸ Even if our product candidate receives regulatory approval in the United States, we may never receive approval to commercialize it outside of the United States.● ● ● ● 4 ▸ Even if our product candidate receives regulatory approval, it may still face future development and regulatory difficulties.● ● ● ● 4 ▸ Future sales and issuances of our common stock or rights to purchase common stock pursuant to our equity incentive plan could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall.● ● ● ● 4 ▸ Guidelines and recommendations published by various organizations can impact the use of our product.● ● ● ● 4 ▸ If a product liability claim is successfully brought against us for uninsured liabilities, or such claim exceeds our insurance coverage, we could be forced to pay substantial damage awards that could materially harm our business.● ● ● ● 4 ▸ If a third party claims we are infringing on its intellectual property rights, we could incur significant expenses, or be prevented from further developing or commercializing our product candidate.● ● ● ● 4 rw ▸ If any product candidate that we develop independently or through collaborations is approved but does not gain meaningful acceptance in its intended market, we are not likely to generate significant revenues or become profitable.● ● ● ● 4 ▸ If government and third-party payers fail to provide adequate reimbursement or coverage for our products or those we develop through collaborations, our revenues and potential for profitability will be harmed.● ● ● ● 4 ▸ If our product candidate is unable to compete effectively with marketed drugs targeting similar indications as our product candidate, our commercial opportunity will be reduced or eliminated.● ● ● ● 4 ▸ If our use of hazardous materials results in contamination or injury, we could suffer significant financial loss.● ● ● ● 4 ▸ If securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding our stock adversely, our stock price and trading volume could decline.● ● ● ● 4 ▸ If we are unable to adequately protect or expand our intellectual property related to our current or future product candidates, our business prospects could be harmed.● ● ● ● 4 ▸ If we are unable to satisfy regulatory requirements, we may not be able to commercialize our product candidate.● ● ● ● 4 ▸ If we fail to comply with healthcare regulations, we could face substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition could be adversely affected.● ● ● ● 4 ▸ If we fail to enter into collaborations, license agreements or other transactions with third parties to accelerate the development of our product candidate, we will bear the risk of developmental failure.● ● ● ● 4 rw ▸ Materials necessary to manufacture our product candidates may not be available on commercially reasonable terms, or at all, which may delay the development and commercialization of our product candidates.● ● ● ● 4 ▸ Our approach to the discovery and development of product candidates based on AI-POWRTM is novel and unproven, and we do not know whether we will be able to develop any products of commercial value.● ● ● ● 4 ▸ Our clinical activities involve the handling of hazardous materials, and we must comply with environmental laws and regulations, which can be expensive and restrict how we do business.● ● ● ● 4 ▸ Our failure to successfully discover, acquire, develop and market additional product candidates or approved products would impair our ability to grow.● ● ● ● 4 ▸ Our operations could be disrupted if our information systems fail, if we are unsuccessful in implementing necessary upgrades or if we are subject to cyber-attacks.● ● ● ● 4 ▸ Our product candidates, if approved for sale, may not gain acceptance among physicians, patients and the medical community, thereby limiting our potential to generate revenues.● ● ● ● 4 ▸ Reimbursement may not be available for our product candidate, which would impede sales.● ● ● ● 4 rw ▸ group Risks Related to Our Business● ● ● ● 4 ▸ group Risks Related to Our Common Stock● ● ● ● 4 ▸ group Risks Related to Our Intellectual Property● ● ● ● 4 ▸ Risks Relating to the Commercialization of our Product Candidate.● ● ● ● 4 rw ▸ U.S. federal income tax reform could adversely affect us.● ● ● ● 4 ▸ We do not currently have any internal drug discovery capabilities, and therefore we are dependent on in-licensing or acquiring development programs from third parties in order to obtain additional product candidates.● ● ● ● 4 ▸ We have incurred losses since inception, anticipate that we will incur continued losses for the foreseeable future indicating the possibility that we may not be able to operate in the future.● ● ● ● 4 ▸ We have limited capacity for recruiting and managing clinical trials, which could impair our timing to initiate or complete clinical trials of our product candidate and materially harm our business.● ● ● ● 4 ▸ We have limited experience in the development of small molecule product candidates and therefore may encounter difficulties developing our product candidate or managing our operations in the future.● ● ● ● 4 ▸ We may be at risk of securities class action litigation.● ● ● ● 4 ▸ We may be required to suspend or discontinue clinical trials due to unexpected side effects or other safety risks that could preclude approval of our product candidate.● ● ● ● 4 ▸ We may be unable to successfully develop a product candidate that is the subject of collaboration if our collaborator does not perform, terminates our agreement, or delays the development of our product candidate.● ● ● ● 4 rw ▸ We may delay or terminate the development of our product candidate at any time if we believe the perceived market or commercial opportunity does not justify further investment, which could materially harm our business.● ● ● ● 4 rw ▸ We may need others to market and commercialize our product candidate in international markets.● ● ● ● 4 ▸ We may not be able to accomplish these tasks, and our failure to accomplish any of them could harm our financial results and impact our ability to achieve development milestones.● ● ● ● 4 ▸ We may not be able to manufacture our product candidates in commercial quantities, which would prevent us from commercializing our product candidates.● ● ● ● 4 ▸ We presently do not intend to pay cash dividends on our common stock.● ● ● ● 4 ▸ We will need to increase the size of our organization.● ● ● ● 4 ▸ We will need to obtain FDA approval of any proposed product brand names, and any failure or delay associated with such approval may adversely impact our business.● ● ● ● 4 ▸ We, and our collaborators, must comply with extensive government regulations in order to advance our product candidate through the development process and ultimately obtain and maintain marketing approval for our products in the U.S. and abroad.● ● ● ● 4