Financial Performance - Ensysce Biosciences, Inc. has an accumulated deficit of $95.5 million as of June 30, 2022, and expects to continue incurring net losses in the foreseeable future [144]. - The company has not generated any revenue from product sales since its inception and does not expect to do so in the near future [153]. - Net loss for Q2 2022 was $7.9 million, compared to a net loss of $1.0 million in Q2 2021, an increase of $6.9 million [177]. - Net loss for the six months ended June 30, 2022, was $8.9 million, compared to a net loss of $1.9 million in the same period of 2021, an increase of $6.9 million [185]. - The company has incurred significant operating losses, with an accumulated deficit of $95.5 million as of June 30, 2022 [213]. Expenses - Ensysce anticipates significant increases in clinical development expenses and general and administrative expenses as it continues its development activities [144]. - Research and development expenses for Q2 2022 were $5.3 million, an increase of $4.8 million from $0.5 million in Q2 2021 [180]. - General and administrative expenses for Q2 2022 were $2.0 million, up $1.6 million from $0.4 million in Q2 2021 [181]. - Total operating expenses for Q2 2022 reached $7.3 million, compared to $0.9 million in Q2 2021, an increase of $6.4 million [177]. - Research and development expenses for the six months ended June 30, 2022, were $8.4 million, up $7.6 million from $0.8 million in the same period of 2021 [187]. - General and administrative expenses for the six months ended June 30, 2022, were $4.2 million, an increase of $3.3 million from $0.9 million in the same period of 2021 [188]. - Cash used in operating activities for the six months ended June 30, 2022, was $7.9 million, a significant increase from $0.6 million in the same period in 2021 [207]. Funding and Capital - The company received approximately $7.8 million in net proceeds from the business combination that occurred on June 30, 2021 [152]. - Ensysce is actively seeking additional funding through private and public equity offerings, debt financings, or collaborations to support its growth strategy [147]. - The company has funded operations primarily through common equity sales, federal research grants, and promissory notes, indicating a need for additional capital in the future [193]. - Current remaining funding under two federal research grants totals $6.3 million, which is available until August 31, 2023 [195]. - The GEM Agreement allows the company to draw down up to $60.0 million from GEM Global, subject to certain conditions [198]. - The company has entered into multiple financing agreements, including a $15.0 million SPA and an $8.0 million SPA with institutional investors [204][205]. - The company has limited cash resources to fund operations for the next 12 months, raising concerns about its ability to continue as a going concern [214]. Clinical Development - The lead product candidate, PF614, is currently in Phase 1b clinical development, while PF614-MPAR™ is in Phase 1 and nafamostat is moving towards Phase 2 clinical development [143]. - Ensysce has not yet completed any pivotal clinical trials or obtained regulatory approvals for its product candidates [143]. - The company expects substantial increases in expenses related to ongoing research and development activities, particularly for clinical trials [212]. Grants and Funding Sources - The company has been awarded federal grants from the NIH for the development of its MPAR overdose prevention technology and TAAP/MPAR abuse deterrent technology [154]. - Federal grant funding for Q2 2022 was $0.2 million, down from $0.4 million in Q2 2021, a decrease of $0.2 million [178]. - Federal grant funding for the six months ended June 30, 2022, was $0.8 million, an increase of $0.1 million from $0.7 million in the same period of 2021 [186]. Company Classification and Reporting - The company qualifies as an "emerging growth company" under the JOBS Act, allowing it to take advantage of certain reporting exemptions [228]. - The company is classified as a "smaller reporting company," which allows for reduced disclosure obligations until specific market value or revenue thresholds are met [229]. Stock-Based Compensation - The company measures stock-based compensation based on fair value at the grant date and recognizes the expense over the vesting period [222]. - The fair value of stock options is estimated using the Black-Scholes model, considering stock volatility, expected term, risk-free interest rate, and dividend yield [224]. - The company elected the fair value option for convertible notes, using a Monte Carlo simulation model for valuation, with changes recognized through earnings [225]. Miscellaneous - The ongoing COVID-19 pandemic has not significantly impacted the company's financial condition or operations to date [149]. - There are no off-balance sheet arrangements currently or during the presented periods [226]. - Cash and cash equivalents as of June 30, 2022, included cash and a money market fund, with minimal impact expected from sudden interest rate changes [230]. - Inflation and changing prices are not believed to have significantly impacted the company's results of operations for the periods presented [231].

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) | --- | --- | |-------------------------------- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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 September 30, 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 No. 001-38306 LEISURE ACQUISITION CORP. (Exact name of registrant as specified in its charter) | --- | --- | |---------------------------- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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 June 30, 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 No. 001-38306 LEISURE ACQUISITION CORP. (Exact name of registrant as specified in its charter) | --- | --- | |--------------------------------- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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, 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 No. 001-38306 LEISURE ACQUISITION CORP. (Exact name of registrant as specified in its charter) | --- | --- | |-------------------------------- ...