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 June 30, 2023 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. Indicate by check mark whether the registrant (1) has filed all reports required ...

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, 2023 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) Delaware 82-2755287 (Sta ...

ENSYSCE BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial As filed with the Securities and Exchange Commission on May 9, 2023 Registration No. 333-271480 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Pre-effective Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Delaware 2834 82-2755287 (I.R.S. Employer Identification Number) 7946 Iva ...

As filed with the Securities and Exchange Commission on May 8, 2023 Registration No. 333-271480 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Pre-effective Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ENSYSCE BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Delaware 2834 82-2755287 (I.R.S. Employer Identification Number) 7946 Iva ...

As filed with the Securities and Exchange Commission on April 27, 2023 Registration No. 333-****** UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ENSYSCE BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) 7946 Ivanhoe Avenue, Suite 201 La Jolla, California 92037 (858) 263-4196 (Address, Including Zip Code, and Telephone Number, Includi ...

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 ...

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