▸ We have a limited operating history with no product revenues to date and a limited number of DRP®biomarker development agreements, which may make it difficult to evaluate the success of our business to date and to assess our future viability.· ● 1 ▸ A Breakthrough Therapy designation by the FDA for stenoparib may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that stenoparib will receive marketing approval.● ● 2 ▸ A Fast Track designation by the FDA may not lead to a faster development or regulatory review or approval process.● ● 2 ▸ Any failure by us to comply with existing regulations could harm our reputation and operating results.● ● 2 ▸ Changes to patent laws in the U.S. and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect stenoparib.● ● 2 ▸ Comprehensive tax reform bills could adversely affect our business and financial condition.● ● 2 ▸ Delays in clinical testing could result in increased costs to us and delay our ability to generate revenue.● ● 2 ▸ Enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize stenoparib and may affect the price we may set.● ● 2 ▸ Even if we are successful in completing all preclinical studies and clinical trials, we may not be successful in commercializing stenoparib.● ● 2 ▸ Even if we obtain regulatory approvals to commercialize stenoparib, stenoparib may not be accepted by physicians or the medical community in general.● ● 2 ▸ Failure to achieve and maintain effective internal controls could have a material adverse effect on our business.● ● 2 ▸ Failure to obtain marketing approval in foreign jurisdictions would prevent stenoparib from being marketed abroad.● ● 2 ▸ Future sales, or the perception of future sales, by us or our stockholders in the public market could cause the market price for our common stock to decline.● ● 2 ▸ Governmental efforts to pursue regulatory reform may limit the FDA’s ability to engage in oversight and implementation activities in the normal course, and that could negatively impact our business.● ● 2 ▸ Governments outside of the U.S. tend to impose strict price controls, which may adversely affect our revenues, if any.● ● 2 ▸ Healthcare reform measures could hinder or prevent stenoparib's commercial success.● ● 2 ▸ If our business developments and achievements do not meet the expectations of investors or securities analysts or for other reasons the expected benefits do not occur, the market price of our common stock traded on Nasdaq may decline.● ● 2 ▸ If we are unable to develop satisfactory sales and marketing capabilities, we may not succeed in commercializing stenoparib.● ● 2 ▸ If we do not obtain patent term extension for stenoparib or obtain a patent on our DRP® companion diagnostic for stenoparib, our business may be materially harmed.● ● 2 ▸ If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.● ● 2 ▸ If we fail to comply with our obligations in our intellectual property licenses and funding arrangements with third parties, we could lose rights that are important to our business.● ● 2 ▸ If we fail to satisfy the Nasdaq Capital Market continued listing requirements and do not regain compliance, our common stock will be delisted.● ● 2 ▸ Intellectual property litigation or other legal proceedings relating to intellectual property could cause us to spend substantial resources and distract our personnel from their normal responsibilities.● ● 2 ▸ Intellectual property rights do not necessarily address all potential threats.● ● 2 ▸ International operations may expose us to business, regulatory, political, operational, financial, pricing, tariffs, and reimbursement risks associated with doing business outside of the U.S.● ● 2 rw ▸ Market and economic conditions may negatively impact our business, financial condition and share price.● ● 2 ▸ Our Certificate of Incorporation and our by-laws, and Delaware law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline.● ● 2 ▸ Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.● ● 2 ▸ Our failure to find third-party collaborators to assist or share in the costs of drug development could materially harm our business, financial condition and results of operations.● ● 2 ▸ Our failure to successfully acquire, develop, and market additional therapeutic candidates could impair our ability to grow.● ● 2 ▸ Our inability to obtain or retain sufficient clinical trial liability insurance at an acceptable cost to protect against potential liability claims could prevent or inhibit our ability to conduct clinical trials for stenoparib.● ● 2 ▸ Our internal computer systems, or those used by our CROs or other contractors or consultants, may fail or experience security breaches or other unauthorized or improper access.● ● 2 ▸ Our proprietary DRP® companion diagnostics platform may fail to help us select and treat likely responder patients for stenoparib or help us identify additional potential therapeutic candidates.● ● 2 ▸ group Risks Related to Our Business and Industry● ● 2 ▸ Risks Related to Our Financial Position and Need for Additional Capital● ● 2 ▸ group Risks Related to Our Intellectual Property● ● 2 ▸ group Risks Related to Our Reliance on Third Parties● ● 2 ▸ Risks Related to Ownership of our Securities and Our Status as a Public Company● ● 2 ▸ group Risks Related to the Approval and Commercialization of Stenoparib● ● 2 rw ▸ group Risks Related to the Discovery and Development of Stenoparib● ● 2 ▸ Smerud Medical Research International and Chosa ApS are responsible for the development of our LiPlaCis® in conjunction with our DRP® companion diagnostic.● ● 2 ▸ The price of our common stock has fluctuated substantially.● ● 2 ▸ There is no assurance that an active and liquid trading market in our common stock will develop.● ● 2 ▸ Unstable global market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.● ● 2 ▸ We depend on our senior management team, and the loss of one or more of our executive officers or key employees or an inability to attract and retain highly skilled employees could adversely affect our business.● ● 2 ▸ We have incurred significant operating losses since inception and anticipate that we will continue to incur substantial operating losses for the foreseeable future and may never achieve or maintain profitability.● ● 2 ▸ We have limited experience in drug discovery and drug development and may not receive regulatory approval to market stenoparib.● ● 2 ▸ We have obtained statistical data, market data and other industry data and forecasts used throughout this Annual Report from market research, publicly available information and industry publications which we believe are reliable.● ● 2 ▸ We may acquire other companies or technologies, which could divert our management’s attention, result in dilution to our stockholders and otherwise disrupt our operations and adversely affect our operating results.● ● 2 ▸ We may be at risk of securities class action litigation.● ● 2 ▸ We may be subject to extensive regulations outside the U.S. and may not obtain marketing approvals for stenoparib in Europe and other jurisdictions.● ● 2 ▸ We may encounter substantial delays in our preclinical studies or clinical trials or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.● ● 2 ▸ We may expend our limited resources to pursue a particular therapeutic candidate or indication and fail to capitalize on therapeutic candidates or indications that may be more profitable or for which there is a greater likelihood of success.● ● 2 ▸ We may experience challenges with the acquisition, development, enhancement or deployment of technology necessary for our proprietary DRP®companion diagnostics platform.● ● 2 ▸ We may in the future develop therapeutic candidates in combination with other therapies and that may expose us to additional risks.● ● 2 ▸ We may not be able to protect our intellectual property and proprietary rights throughout the world.● ● 2 ▸ We may rely on orphan drug status to commercialize stenoparib, and even if orphan drug status is approved, such approval may not confer marketing exclusivity or other commercial advantages or expected commercial benefits.● ● 2 ▸ We operate in a highly competitive and rapidly changing industry.● ● 2 ▸ We or our licensors may become involved in lawsuits to protect or enforce our patent or other intellectual property rights, which could be expensive, time-consuming and unsuccessful.● ● 2 ▸ We will need substantial additional funding, and if we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our drug development program for stenoparib or its commercialization efforts.● ● 2 ▸ We will need to increase the size of our organization and the scope of our outside vendor relationships, and we may experience difficulties in managing growth.● ● 2 ▸ We, or third-party manufacturers on whom we rely, may be unable to successfully scale-up manufacturing of stenoparib in sufficient quality and quantity, which would delay or prevent us from developing and commercializing stenoparib.● ● 2 
