Ensysce Biosciences, Inc. 10-Q

Item 1A. Risk Factors. While we attempt to identify, manage and mitigate risks and uncertainties associated with our business to the extent practical, under the circumstances, some level of risk and uncertainty will always be present. Part I, Item 1A. Risk Factors of our 2021 Annual Report on Form 10-K includes a detailed discussion of our risk factors. Those risks and uncertainties have the potential to materially affect our financial condition and results of operations. The risks set forth in the following additional risk factors have the potential to materially affect our financial condition and results of operations. FDA’s evolving standards for the approval of opioid products may delay or prevent approval of our product candidates. FDA has identified addressing misuse and abuse of opioid drugs as one of its highest priorities. As part of its plan, the agency has established new standards for the development of prescription opioids with abuse-deterrent formulations and has published two sets of guidance. Since the publication of the second guidance in November 2017, FDA has not approved any new abuse–deterrent opioid drugs. If we are unable to meet FDA’s new and evolving standards for approving opioid products, we will not be able to market our products. Fast track designation by the FDA for PF614 for chronic pain may not lead to a faster development or regulatory review or approval process and does not assure FDA approval. We have obtained fast track designation for PF614 for management of moderate to severe chronic pain when a continuous, around-the-clock analgesic is needed for an extended period of time. We believe that fast track designation will enable us to facilitate the development and expedite the review of PF614. Fast track designation does not ensure that PF614 will receive marketing approval or that approval will be granted within any particular timeframe. As a result, we may not experience a faster development process, review or approval compared to conventional FDA procedures. In addition, the FDA may withdraw fast track designation if it believes that the designation is no longer supported by data from our clinical development program. Fast track designation does not guarantee that an NDA will obtain priority review designation. If any of these events occur, it could require us to conduct more extensive clinical trials and go through more extensive FDA review, which could substantially increase expenses and delay the time for commercializing our products. Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our common stock. Our common stock is currently listed for trading on The Nasdaq Capital Market. We must satisfy the continued listing requirements of Nasdaq, to maintain the listing of our common stock on The Nasdaq Capital Market. A delisting of our common stock from Nasdaq could materially reduce the liquidity of our common stock and result in a corresponding material reduction in the price of our common stock. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities. On June 16, 2022, we received written notice (the “ Notice ”) from Nasdaq that our Minimum Value of Listed Securities (“ MVLS ”) was below the minimum of $35 million required for continued listing. We have until December 13, 2022, to regain compliance. To regain compliance, the MVLS must close at $35 million or more for a minimum of ten consecutive business days (or such longer period of time Nasdaq may require) during the compliance period ending December 13, 2022. The Company could also regain compliance by meeting the continued listing standard of a minimum stockholders’ equity of at least $2.5 million, which standard the Company does not meet currently. If compliance is not regained by December 13, 2022, Nasdaq will provide written notice that our securities are subject to delisting. At that time, we may appeal any such delisting determination to a Nasdaq hearings panel. On June 17, 2022, we received written notice from Nasdaq that we were not in compliance with the Nasdaq requirement for the bid price for our common stock to be at least $1.00 per share (the “ Deficiency Letter ”). We have until December 14, 2022, for the bid price for our common stock to close at $1.00 per share or more (the “ Minimum Bid Price ”) for a minimum of 10 consecutive business days during the compliance period ending December 14, 2022 (or such longer period of time Nasdaq may require). If compliance is not regained by December 14, 2022, Nasdaq staff will provide notice that our securities are subject to delisting. At that time, we may appeal any such delisting determination to a Nasdaq hearings panel. We actively monitor the price of the Company’s common stock and are evaluating available options to resolve the deficiencies and regain compliance with the MVLS and Minimum Bid Price requirements. We effected the Reserve Split to regain compliance with the Minimum Bid Price requirement. On November 11, 2022, we received written notice from Nasdaq that we had regained compliance with the Minimum Bid Price requirement. 39 If our common stock were delisted from Nasdaq, trading of our common stock would most likely take place on an over-the-counter market established for unlisted securities, such as the OTCQB or the Pink Market maintained by OTC Markets Group Inc. An investor would likely find it less convenient to sell, or to obtain accurate quotations in seeking to buy, our common stock on an over-the-counter market, and many investors would likely not buy or sell our common stock due to difficulty in accessing over-the-counter markets, policies preventing them from trading in securities not listed on a national exchange or other reasons. In addition, as a delisted security, our common stock would be subject to SEC rules as a “ penny stock ,” which impose additional disclosure requirements on broker-dealers. The regulations relating to penny stocks, coupled with the typically higher cost per trade to the investor of penny stocks due to factors such as broker commissions generally representing a higher percentage of the price of a penny stock than of a higher-priced stock, would further limit the ability of investors to trade in our common stock. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, suppliers, customers and employees and fewer business development opportunities. For these reasons and others, delisting would adversely affect the liquidity, trading volume and price of our common stock, causing the value of an investment in us to decrease and having an adverse effect on our business, financial condition and results of operations, including our ability to attract and retain qualified employees and to raise capital. Item 2. Unregistered Sales of Equity Securities and Use of Proceeds. None. Item 3. Defaults Upon Senior Securities. Not applicable. Item 4. Mine Safety Disclosures. Not applicable.