▸ Additional indirect taxes in various jurisdictions could materially adversely affect our business, financial condition, results of operations, and prospects.· · · · · ● 1 ▸ Because our future commercial success depends on gaining regulatory approval for our products, we cannot generate revenue without obtaining approvals.· · · · · ● 1 ▸ Because the approach we are taking to discover and develop drugs is novel, including the usage of AI, it may never lead to marketable products.· · · · · ● 1 ▸ Because we face significant competition from other biotechnology and pharmaceutical companies, our operating results will suffer if we fail to compete effectively.· · · · · ● 1 ▸ Because we will face potential product liability as we further develop potential product candidates and more so if we can commercialize any product candidate, if claims are brought against us, we may incur substantial liability and costs.· · · · · ● 1 ▸ Business interruptions resulting from natural disasters and adverse weather events could cause delays in research and development of our potential product candidates.· · · · · ● 1 ▸ Changes in tax laws or exposure to additional income tax liabilities could have a material impact on our business, results of operations, financial condition and cash flows.· · · · · ● 1 ▸ Failure of our information technology infrastructure to operate effectively could adversely affect our business.· · · · · ● 1 ▸ Financial reporting obligations of being a public company in the U.S. are expensive and time-consuming, and our management is required to devote substantial time to compliance matters.· · · · · ● 1 ▸ Following regulatory approval for a product candidate, we will still face extensive regulatory requirements, and the approved product may face future development and regulatory difficulties.· · · · · ● 1 ▸ If any strategic alliances on which we depend are unsuccessful or are terminated, we may be unable to develop or commercialize certain potential product candidates and we may be unable to generate revenues from our development programs.· · · · · ● 1 ▸ If securities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business, our stock price and trading volume may decline.· · · · · ● 1 ▸ If third-party intellectual property infringement claims are asserted against us, it may prevent or delay our development and commercialization efforts and have a material adverse effect on our business and future prospects.· · · · · ● 1 ▸ If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our potential product candidates, we may be unable to generate any revenues from product sales.· · · · · ● 1 ▸ If we are unable to successfully complete preclinical testing and clinical trials of our potential product candidates or experience significant delays in doing so, our business will be materially harmed.· · · · · ● 1 ▸ If we cannot obtain or protect intellectual property rights related to our future products and potential product candidates, we may not be able to compete effectively in our markets.· · · · · ● 1 ▸ If we do not succeed in our efforts to identify or discover additional potential product candidates, your investment may be lost.· · · · · ● 1 ▸ If we fail to comply with applicable laws and regulations, including 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 our business.· · · · · ● 1 ▸ If we lose key management or scientific personnel, cannot recruit qualified employees, directors, officers, or other personnel or experience increases in our compensation costs, our business may materially suffer.· · · · · ● 1 ▸ If we obtain approval to commercialize any approved products outside of the United States, a variety of risks associated with international operations could materially adversely affect our business.· · · · · ● 1 ▸ If we obtain regulatory approval for one product candidate, we expect sales to generate substantially all of our product revenues, and as such, the failure of such product to find market acceptance would adversely affect our results of operations.· · · · · ● 1 ▸ Nasdaq may delist our securities from trading on its exchange, which could limit investors’ ability to make transactions in our securities and subject us to additional trading restrictions.· · · · · ● 1 ▸ Our ability to use our net operating losses and tax credits to offset future taxable income and income tax liabilities may be limited.· · · · · ● 1 ▸ Our business could be negatively impacted by cybersecurity threats and other security threats and disruptions.· · · · · ● 1 ▸ Our certificate of incorporation, our bylaws, 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.· · · · · ● 1 ▸ Our financial condition raises substantial doubt regarding our ability to continue as a going concern.· · · · · ● 1 ▸ Our potential product candidates may cause adverse effects or have other properties that could delay or prevent their regulatory approval or limit the scope of any approved label or market acceptance.· · · · · ● 1 ▸ group Risks Related to Our Operations and Industry· · · · · ● 1 ▸ The commercial success of our potential product candidates will depend upon the acceptance of these potential product candidates by the medical community, including physicians, patients and healthcare payors.· · · · · ● 1 ▸ The price of our common stock may fluctuate substantially.· · · · · ● 1 ▸ We are a “smaller reporting company” and are able to avail ourselves of reduced disclosure requirements applicable to smaller reporting companies, which could make our common stock less attractive to investors.· · · · · ● 1 ▸ We have limited experience in conducting and managing the preclinical development activities and clinical trials necessary to obtain approvals for marketing our potential product candidates, including approval by the FDA.· · · · · ● 1 ▸ We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.· · · · · ● 1 ▸ We may need to obtain additional licenses to intellectual property rights from third parties.· · · · · ● 1 ▸ We may not be able to successfully complete such negotiations and ultimately acquire the rights to the intellectual property surrounding potential product candidates that we may seek to acquire, in which case our business could be harmed.· · · · · ● 1 ▸ We may become involved in 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.· · · · ● ● 2 rw ▸ Certain provisions of the Merger Agreement may discourage third parties from submitting alternative takeover proposals, including proposals that may be superior to the arrangements contemplated by the Merger Agreement.· · · · ● · 1 ▸ During the pendency of the Merger, Salarius may not be able to enter into a business combination with another party at a favorable price because of restrictions in the Merger Agreement, which could adversely affect its business.· · · · ● · 1 ▸ group Risks Related to the Merger· · · · ● · 1 ▸ Salarius is substantially dependent on its remaining employees and consultants to facilitate the consummation of the Merger.· · · · ● · 1 ▸ Salarius may face potential product liability, and, if successful claims are brought against Salarius, Salarius may incur substantial liability and costs which could be greater than Salarius’ insurance coverage or overall resources.· · · · ● · 1 ▸ Salarius’ common stock may be subject to delisting from Nasdaq, which would seriously harm the liquidity of our stock and our ability to raise capital or complete a strategic transaction.· · · · ● · 1 ▸ Should they occur, any of these matters could adversely affect the trading price of Salarius’ common stock or harm its business, financial condition and prospects.· · · · ● · 1 ▸ Stockholders of the combined company may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger and the Qualified Financing.· · · · ● · 1 ▸ The Merger Agreement between Salarius and Decoy may be terminated in accordance with its terms and the Merger may not be completed.· · · · ● · 1 ▸ The Merger may be completed even though certain events occur prior to Merger Closing that materially and adversely affect Salarius.· · · · ● · 1 ▸ 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.· · · ● · · 1 ▸ 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.· · · ● ● · 2 ▸ If patients are unwilling to participate in our clinical trials for any reason, the timeline for conducting trials and obtaining regulatory approval of our product candidates will be delayed.· · · ● · · 1 ▸ On August 5, 2023, we initiated a cost savings plan intended to preserve capital while we assess potential strategic alternatives.· · · ● · · 1 ▸ 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.· · · ● · · 1 ▸ group Risks Related to our Financial Position and Capital Needs· · · ● ● · 2 ▸ 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.· · · ● · · 1 ▸ We could be delisted from Nasdaq, which would seriously harm the liquidity of our stock and our ability to raise capital.· · · ● · · 1 ▸ group Risks Related to our Ability to Continue as a Going Concern· · ● · · · 1 ▸ Sales of a substantial number of our shares of common stock in the public markets, or the perception that such sales could occur, including from the exercise of warrants or sales of common stock issuable thereunder, could· · ● · · · 1 ▸ The process of reviewing and approving a drug is time-consuming, unpredictable, and dependent on a variety of factors outside of our control. The FDA and corresponding regulatory authorities in other jurisdictions have a· · ● ● · · 2 ▸ We may not be able to initiate or continue clinical trials if we cannot enroll a sufficient number of eligible patients to participate in the clinical trials required by regulatory agencies.· ● ● · · · 2 ▸ We may not have the right to prohibit the U.S. government from using specified technologies developed by us, and we may not be able to prohibit third-party companies, including our competitors, from using those technologies in· ● · · · · 1 ▸ Any of these events could prevent us from achieving or maintaining market acceptance of a product candidate, even if approved, and could significantly harm or cause the complete failure of our business, results of operations, and prospects.● ● ● ● · · 4 rw ▸ Any regulatory approvals that Salarius receives for its product candidates may be subject to limitations on the approved indicated uses for which the product candidate may be marketed or to the conditions of approval, or● · · · · · 1 ▸ Clinical trials are costly, time consuming and inherently risky, and may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.● ● ● ● ● · 5 rw ▸ Even if Salarius obtains regulatory approval for a product, Salarius will remain subject to ongoing regulatory requirements.● · · · · · 1 ▸ Even if we obtain regulatory approval to market a product candidate, our future revenue will depend upon the size of any markets in which our product candidates may receive approval, and our ability to achieve sufficient market● · · · · · 1 ▸ Failure in our information technology and storage systems could significantly disrupt the operation of our business and/or lead to potential large liabilities.● ● ● ● ● · 5 rw ▸ Failure to obtain or maintain adequate reimbursement or insurance coverage for products when approved to market, if any, could limit our ability to market those products and decrease our ability to generate revenue.● ● ● · · · 3 rw ▸ Healthcare reform measures may have a material adverse effect on our business, financial condition or results of operations.● ● ● ● · · 4 rw ▸ If Salarius is unable to maintain effective proprietary rights for Salarius’ product candidates or any future product candidates, Salarius may not be able to compete effectively in Salarius’ proposed markets.● ● ● ● ● · 5 rw ▸ If Salarius obtains FDA approval for any of its product candidates and begins commercializing those products in the United States, its operations may be subject to various federal and state fraud and abuse laws, including, without● · · · · · 1 ▸ If the market opportunities for our product candidates are smaller than we believe they are, we may not meet our future revenue expectations and, assuming approval of a product candidate, our business may suffer.● ● ● · · · 3 rw ▸ If we are unable to maintain listing of our securities on the Nasdaq Capital Market or another reputable stock exchange, it may be more difficult for our stockholders to sell their securities.● · · · · · 1 ▸ If we fail to maintain compliance with any such requirements that may apply to us now or in the future, we may be subject to potential liability and to termination of our contracts.● ● ● ● · · 4 rw ▸ It is also possible that Salarius has failed to identify relevant third-party patents or applications. For example, applications filed before November 29, 2000 and applications filed after that date that will not be filed outside the● · · · · · 1 ▸ Our future success depends in part on our ability to retain our president and chief executive officer and our executive vice president of finance and chief financial officer, and to attract, retain, and motivate other qualified personnel.● ● ● · · · 3 rw ▸ Our therapeutic product candidates are based on a relatively novel technology, which makes it difficult to predict the timing and cost of development and of subsequently obtaining regulatory approval, if at all.● ● ● · · · 3 rw ▸ 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.● ● ● ● ● · 5 ▸ Product liability claims may subject us to the foregoing and other risks, which could have a material adverse effect on our business, financial condition or results of operations.● ● ● · · · 3 rw ▸ Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights.● ● ● ● · · 4 rw ▸ Risks Related to Regulatory Approval of Salarius’ Product Candidates and Other Legal Compliance Matters● ● ● ● ● · 5 rw ▸ group Risks Related to Salarius’ Intellectual Property● ● ● ● ● · 5 rw ▸ group Risks Related to Salarius’ Reliance on Third Parties● ● ● ● ● · 5 rw ▸ group Risks Related to our Financial Condition and Capital Requirements● ● ● · · · 3 rw ▸ group Risks Related to the Development of Salarius’ Product Candidates● ● ● ● ● · 5 rw ▸ Salarius has never generated any revenue from product sales and may never generate revenue or be profitable.● ● ● ● ● · 5 rw ▸ Salarius may be unable to acquire or in-license any compositions, methods of use, processes, or other third-party intellectual property rights from third parties that Salarius identifies as necessary for Salarius’ product candidates.● ● ● ● ● · 5 rw ▸ Salarius may not be able to protect Salarius’ intellectual property rights throughout the world.● ● ● ● ● · 5 rw ▸ Salarius may not have sufficient patent term protections for Salarius’ product candidates to effectively protect Salarius’ business.● ● ● ● ● · 5 rw ▸ Salarius may seek breakthrough therapy designation by the FDA for one or more of its product candidates, but it might not receive such designation.● · · · · · 1 ▸ Salarius received Fast Track designation for one or more of its product candidates, but such designation may not actually lead to a faster development or regulatory review or approval process.● · · · · · 1 ▸ Salarius’ commercial success depends in part on Salarius’ ability to develop, manufacture, market and sell Salarius’ product candidates and use Salarius’ proprietary technology without infringing the patent rights of third parties.● ● ● ● ● · 5 rw ▸ The approach Salarius has taken to discover and develop novel oncology therapeutics using epigenetic enzymes to moderate transcription factors and thereby control abnormal protein expression is unproven and may never lead to marketable products.● ● ● ● ● · 5 rw ▸ The commercial success of any of our current or future product candidates will depend upon the degree of market acceptance by physicians, patients, third-party payors, and others in the medical community.● ● ● · · · 3 rw ▸ The patent protection and patent prosecution for some of our product candidates is dependent on third parties.● ● ● ● · · 4 rw ▸ The terms of the warrants could impede our ability to enter into certain transactions or obtain additional financing.● ● ● ● · · 4 ▸ Third-party claims of intellectual property infringement may prevent or delay Salarius’ development and commercialization efforts.● ● ● ● ● · 5 rw ▸ We face substantial competition and our competitors may discover, develop or commercialize products faster or more successfully than us.● ● ● · · · 3 rw ▸ We have incurred losses since our inception, have a limited operating history on which to assess our business, and anticipate that we will continue to incur significant losses for the foreseeable future.● · · · · · 1 ▸ We may attempt to form collaborations in the future with respect to our product candidates, but we may not be able to do so, which may cause us to alter our development and commercialization plans.● ● ● · · · 3 rw ▸ We may be unable to realize the potential benefits of any current or future collaboration.● ● ● ● · · 4 rw ▸ We may face business disruption and related risks resulting from the ongoing COVID-19 pandemic.● ● · · · · 2 ▸ We may not be successful in any efforts to identify, license, discover, develop, or commercialize additional product candidates.● ● ● · · · 3 rw ▸ We will need to expand our organization and we may experience difficulties in managing this growth, which could disrupt our operations.● ● ● · · · 3 rw ▸ group Risks Related to our Business● ● ● ● · ● 5 rw ▸ Risks Related to the Discovery, Development and Commercialization of Potential Product Candidates● ● ● · · ● 4 rw ▸ 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 or cause our stock price to decline.● ● ● ● ● ● 6 ▸ group Risks Related to Ownership of our Common Stock● ● ● ● ● ● 6 rw ▸ We do not currently intend to pay dividends on our common stock, and any return to investors is expected to come, if at all, only from potential increases in the price of our common stock.● ● ● ● ● ● 6 ▸ We may in the future be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.● ● ● ● ● ● 6 rw ▸ We may not succeed in obtaining or maintaining necessary rights to drug compounds and processes for our development pipeline through acquisitions and in-licenses.● ● ● ● ● ● 6 rw