Financial Performance - Ensysce has incurred significant operating losses since its inception and expects to continue incurring net losses for the foreseeable future[119]. - The company has not generated any revenue from product sales and may never be able to commercialize a marketable product[117]. - The Company has generated limited revenue since inception and does not expect to generate revenue from product sales in the near future[144]. - The net loss for the three months ended September 30, 2023, was $2.7 million, significantly improved from a net loss of $9.9 million in the same period of 2022, representing a change of $7.2 million[165]. - The net loss for the nine months ended September 30, 2023, was $7.1 million, an improvement of $11.6 million compared to a net loss of $18.7 million in the same period of 2022[170]. - As of September 30, 2023, the company had an accumulated deficit of $118 million and expects to continue incurring significant operating losses[194]. Funding and Financial Agreements - Ensysce requires substantial additional funding to support ongoing operations and growth strategy, with current cash expected to be insufficient to fund operations through the end of Q1 2024[124][121]. - The company completed a public offering on May 12, 2023, raising approximately $7.0 million before fees, by issuing 1,800,876 shares of common stock[138]. - In February 2023, Ensysce raised approximately $3.0 million through a registered direct offering of 297,619 shares at $10.08 per share[133]. - The Company entered into a Securities Purchase Agreement for an aggregate financing of $1.7 million, with the first closing on October 25, 2023, issuing senior secured convertible promissory notes totaling $612,000 and warrants for 1,255,697 shares[141]. - The Company has entered into various financing agreements, including an $8.0 million convertible financing agreement in June 2022[128]. - Without proceeds from the GEM facility or other financing, existing cash resources are insufficient to fund planned operations for the next 12 months, raising doubts about the company's ability to continue as a going concern[195]. Research and Development - The lead product candidate, PF614, is in Phase 2 clinical development, while PF614-MPAR is in Phase 1b, and nafamostat is moving towards Phase 2[118]. - The company has not yet completed any pivotal clinical trials or obtained regulatory approvals for its product candidates[118]. - Research and development expenses are expected to remain elevated due to ongoing clinical trials for product candidates, including PF614, PF614-MPAR, and nafamostat[149]. - Research and development expenses decreased to $1.9 million in Q3 2023 from $4.8 million in Q3 2022, a reduction of $2.9 million[167]. - Research and development expenses for the nine months ended September 30, 2023, were $5.4 million, down from $13.4 million in 2022, a decrease of $8.0 million[172]. - The company anticipates substantial increases in expenses related to ongoing preclinical activities and clinical trials, as well as costs associated with operating as a public company[191]. Administrative Expenses - General and administrative expenses are anticipated to increase as the Company expands its headcount to support product development[153]. - General and administrative expenses for Q3 2023 were $1.2 million, down $0.5 million from $1.7 million in Q3 2022[168]. - General and administrative expenses for the nine months ended September 30, 2023, were $3.9 million, a decrease of $1.8 million from $5.7 million in 2022[173]. Grants and Other Income - The Company has received federal grants from the NIH for the development of overdose prevention technology and abuse deterrent technology for Opioid Use Disorder[145]. - Federal grants for the three months ended September 30, 2023, totaled $0.4 million, an increase of $0.1 million from $0.3 million in 2022[166]. - For the nine months ended September 30, 2023, federal grants amounted to $1.7 million, up from $1.1 million in 2022, an increase of $0.6 million[171]. Cash Flow and Liquidity - As of September 30, 2023, the company had $1.5 million in cash and cash equivalents and entered into a financing agreement for $1.7 million on October 23, 2023[175]. - For the nine months ended September 30, 2023, net cash used in operating activities was $8.98 million, a decrease from $14.59 million in the same period of 2022[186]. - Net cash provided by financing activities for the nine months ended September 30, 2023, was $7.29 million, compared to $6.83 million in 2022, primarily from proceeds of $9.1 million from offerings[189]. Tax and Valuation - The Company maintains a full valuation allowance against all deferred tax assets due to uncertainty in generating future taxable income[162]. - The Company has not recorded significant income tax expenses or reserves related to uncertain tax positions due to net losses incurred to date[161]. - The issuance of liability classified warrants is accounted for using a Black-Scholes option pricing model, with changes in fair value recognized through earnings[158]. Company Classification - The company is classified as an "emerging growth company" and a "smaller reporting company," allowing it to take advantage of certain reduced disclosure obligations[209][210].

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 ...

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