Salarius Pharmaceuticals Inc

Our business is subject to numerous risks and uncertainties, including those discussed at length in the section titled “Risk Factors.” These risks include, among others, the following:

Risks Related to our Financial Position and Capital Needs

•We do not currently have sufficient working capital to fund our planned operations for the next twelve months and may not be able to continue as a going concern. There is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.

•Our activities to evaluate and pursue strategic alternatives has not resulted in and may never result in any definitive transaction or enhance shareholder value, and may create a distraction for our management and uncertainty that may adversely affect our operating results and business.

•If we do not successfully complete a strategic transaction or raise additional capital, we will need to pursue a dissolution and liquidation of our company. In such an event, the amount of cash available for distribution to our stockholders will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved for commitments and contingent liabilities.

•We could be delisted from Nasdaq, which would seriously harm the liquidity of our stock and our ability to raise capital.

•Certain of our warrants to purchase common stock include a right to receive the Black-Scholes value of the unexercised portion of the warrants in the event of a fundamental transaction, which payment could be significant.

•The terms of the warrants could impede our ability to enter into transactions or obtain additional financing.

•Our cost savings plans and the associated headcount reductions may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business.

•We have never generated any revenue from product sales and may never generate revenue or be profitable.

•Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights.

Risks Related to the Development of our Product Candidates

•Our approach to discovering and developing novel oncology therapeutics makes it difficult to predict timing and costs and obtaining regulatory approval may never lead to marketable products.

•Clinical trials are costly, time consuming and inherently risky, and we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities

•Product development involves a lengthy and expensive process with an uncertain outcome, and results of earlier pre-clinical and clinical trials may not be predictive of future clinical trial results.

•We cannot give any assurance that our clinical trials will generate positive data for any of our product candidates or indications which we are pursuing.

•Difficulty in enrolling patients is a common hurdle faced by early stage biotechnology companies and could, and often does, delay or prevent clinical trials of product candidates.

•We may face potential product liability and incur substantial liability and costs and our regulatory approvals, if any, could be revoked or otherwise negatively impacted.

Risks Related to Regulatory Approval of our Product Candidates and Other Legal Compliance Matters

•Fast Track designation may not actually lead to a faster development or regulatory review or approval process. Additionally, FDA may rescind the designation if it determines the product candidate no longer meets the qualifying criteria for Fast Track.

•We may fail to obtain the necessary regulatory approvals to market our product candidates and may not be able to commercialize our product candidates.

•Even if we obtain regulatory approval for a product, we will remain subject to ongoing regulatory requirements, we may be subject to penalties if we fail to comply with regulatory requirements.

•Healthcare reform measures may have a material adverse effect on our business, financial condition or results of operations.

•We may be subject to fraud and abuse laws, false claims laws, and health information privacy and security laws under which we could become subject to substantial penalties.

•Reliance on government funding for our programs may add uncertainty to our research and commercialization efforts and may impose requirements that limit our ability to take specified actions.

Risks Related to our Intellectual Property

•We may not be successful in obtaining or maintaining exclusive or other necessary rights to our targets, product compounds and processes for our development pipeline.

•We may not have sufficient patent term protections for our product candidates to protect our business.

•Changes in U.S. patent law could diminish the value of patents in general and could increase the uncertainties and costs surrounding prosecution and enforcement.

•Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.

•The patent protection and patent prosecution for some of our product candidates is dependent on third parties.

•If we fail to comply with obligations in the agreements under which we license intellectual property and other rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.

•We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming, and unsuccessful.

Risks Related to our Reliance on Third Parties

•If third parties on which we rely fail to obtain or maintain approval of government regulators, fail to comply with applicable regulations, fail to provide us with sufficient quantities of drug product, or fail to do so at acceptable quality levels or prices, we may not be able to successfully complete clinical development, obtain regulatory approval or commercialize our product candidates and our business could be substantially harmed.

•We may be unable to realize the potential benefits of any current or future collaboration.

Risks Related to our Business Operations

•We are substantially dependent on our remaining employees and consultants to continue our operations and facilitate the consideration and consummation of a potential strategic transaction.

Risks Related to Our Common Stock

•Future sales of a significant number of our shares of common stock in the public markets, or the perception that such sales could occur, could depress the market price of our shares of our common stock.

•We do not currently intend to pay dividends on our common stock