Ensysce Biosciences Inc 2026年季度报告

Form 10-Q ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: March 31, 2026 OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period fromto Commission File Number 001-38306 ENSYSCE BIOSCIENCES, INC.(Exact name of registrant as specified in its charter) SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT: Common Stock, $0.0001 par value per shareWarrants, to purchase one share of Common Stock Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the SecuritiesExchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),and (2) has been subject to such filing requirements for the past 90 days. Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submittedpursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit such files). Yes☒No☐ Indicate by check mark whether registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reportingcompany, or an emerging growth company. See definitions of “large accelerated filer”, “accelerated filer”, “smaller reportingcompany”, and “emerging growth company” in Rule 12b-2 of the Exchange Act: Accelerated filer☐Smaller reporting company☒Emerging growth company☐ Large accelerated filer☐Non-accelerated filer☒ If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period forcomplying with any new or revised financial accounting standards provided pursuant to section 13(a) of the Exchange Act☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐No☒ Registrant had 14,694,492 shares of common stock outstanding as of May 14, 2026. FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. In somecases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”“intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will” and “would,” or thenegative of these terms or other similar expressions intended to identify statements about the future. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe mayaffect our business, financial condition and results of operations. These forward-looking statements include, without limitation,statements about: ●our estimates regarding expenses, revenue, capital requirements and timing and availability of and the need for additionalfinancing will almost certainly not match actual amounts and timing;●the dilutive effect of recent financing transactions which may negatively affect our stock price;●our ability to continue as a going concern for the next twelve months;●the risk that our common stock will be delisted from Nasdaq if we are not able to maintain compliance with applicablelisting standards;●the risk that our lead product candidate PF614 and PF614-MPAR may not be successful in limiting or impeding abuse,overdose, or misuse or providing additional safety upon commercialization;●reliance by us on third-party contract research organizations, or CROs, for our research and development activities andclinical trials;●the need for substantial additional funding to complete the development and commercialization of our productcandidates;●the risk that our clinical trials may fail to replicate positive results from earlier preclinical studies or clinical trialsconducted by us or third parties;●the risk that the potential product candidates that we develop may not progress through clinical development or receiverequired regulatory approvals within expected timelines or at all; ●the risk that clinical trials may not confirm any safety, potency, or other product characteristics described or assumed inthis Quarterly Report on Form 10-Q;●the risk that we will be unable to successfully market or gain market acceptance of our product candidates;●the risk that our product candidates may not be beneficial to patients or successfully commercialized;●the risk that we have overestimated the size of the target market, patients’ willingness to try new therapies, and thewillingness of physicians to prescribe these therapies;●effects of competition;●the risk that third parties on which we depend for laboratory, clinical development, manufacturing, and other criticalservices will fail to perform satisfactorily;●the risk that our busines