Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. Yes ☐ No ☒ Commission File Number 001-38306 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.0001 par value per share ENSC The Nasdaq Stock Market LLC Warrants to purchase one share of Common Stock ENSCW OTC Pink Open Market Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☒ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ...

NASDAQ: ENSC Improving Prescription Drug Safety Through Chemistry Investor Presentation September 2022 Disclaimer Ensysce's PF614 and nafamostat are currently in clinical and pre-clinical trials, involving both the TAAP platform and MPAR platform. Accordingly, PF614 and nafamostat have the risks and uncertainties inherent in any drug in trial-phase, which include, but are not limited to, a failure to show sufficient efficacy to obtain FDA approval, the risk that clinical trials may not confirm any safety, p ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.0001 par value per share Warrants to purchase one share of Common Stock ENSC ENSCW The Nasdaq Stock Market LLC OTC Pink Open Market Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☒ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-38306 Ensysce Biosciences, Inc. (Exact Name of Registrant as Specified in its Charter) | --- | |--------------- ...

Ensysce Biosciences, Inc. Corporate Update Conference Call Summary Company Overview - **Company**: Ensysce Biosciences, Inc. (NASDAQ: ENSC) - **Industry**: Biotech, focusing on opioid drug development - **Key Technologies**: - **TAAP** (Trypsin-Activated Abuse Protection): Aims to reduce abuse and overdose of opioids - **MPAR** (Multi-Pill Abuse Resistance): Designed to prevent overdose when more than the prescribed dose is taken - **Investment**: Over $100 million since inception, with more than 100 patents issued in 25 countries [5][6] Core Points and Arguments - **Focus on Opioid Crisis**: Ensysce aims to address the opioid crisis through innovative drug safety technologies [5] - **FDA Approval**: Received FDA allowance for Investigational New Drug Application (IND) for PF614-MPAR, a combination product for abuse deterrence and overdose protection [8] - **Funding**: Received $2.8 million from the National Institute on Drug Abuse (NIDA) for Phase 1 study of PF614-MPAR, totaling $8 million in support from NIDA [9] - **Public Market Debut**: Listing on NASDAQ has provided opportunities for clinical program progression [10] - **Management Team Expansion**: Appointment of Dr. Linda Pestano as Chief Development Officer to enhance drug development efforts [11] Clinical Program Updates - **Phase 1 Study Enrollment**: First patients enrolled in the Phase 1 study of PF614-MPAR, which combines abuse and overdose protection [12] - **Multi-Ascending Dose Study**: Completed first part of clinical study PF614-102, with data expected by the end of Q2 2022 [14] - **Bioequivalence Study**: Initiated in January 2022, comparing PF614 to OxyContin, with data expected by the end of Q2 2022 [14] - **Human Abuse Liability Studies**: Two studies planned to evaluate abuse deterrent labeling, with data expected in Q3 2022 and Q1 2023 [15][24] Financial Highlights - **Revenue Growth**: Federal grant funding increased to $1.6 million in Q4 2021 from $0.4 million in Q4 2020; total funding for 2021 was $3.5 million [17] - **Operating Expenses**: R&D expenses rose to $2.2 million in Q4 2021 from $1.3 million in Q4 2020; G&A expenses increased significantly due to public company costs [18] - **Net Loss**: Total net loss for 2021 was $29.1 million, with significant non-cash expenses related to fair value adjustments [20] - **Cash Position**: Ended 2021 with $12.3 million in cash, up from $0.2 million at the end of 2020 [21] Future Outlook - **Upcoming Milestones**: Anticipated reporting on three major data milestones by the end of 2022, including clinical study results and safety data [24] - **Market Positioning**: Ensysce believes it is well-positioned to create long-term shareholder value by addressing prescription drug abuse and expanding its technology platforms [23] Additional Considerations - **Supply Chain Issues**: Acknowledgment of prevalent supply chain issues affecting drug development timelines [25] - **Regulatory Pathway**: Ongoing discussions with the FDA regarding the 505(b)(2) regulatory pathway for PF614 [33] This summary encapsulates the key points from the Ensysce Biosciences conference call, highlighting the company's focus on innovative opioid solutions, financial performance, and future milestones.

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-38306 ENSYSCE BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) | --- | --- | |----------------------------------------- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.0001 par value per share Warrants to purchase one share of Common Stock ENSC ENSCW The Nasdaq Stock Market LLC The Nasdaq Stock Market LLC Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☒ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SEC ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Delaware 82-2755287 ( State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 7946 Ivanhoe Avenue, Suite 201 La Jolla, California 92037 (Address of principal executive offices) (Zip Code) Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.0001 par value per share Warrants to purchase one share of Common Stock ENSC ENSCW The Nasdaq Stock Market LLC The ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission file number: 001-38306 LEISURE ACQUISITION CORP. (Exact name of registrant as specified in its charter) | --- | --- | |-------------------------------- ...