Financial Performance - Ensysce has incurred significant operating losses since its inception and expects to continue incurring net losses for the foreseeable future[97]. - The company has not generated any revenue from product sales and may never be able to commercialize a marketable product[95]. - Net income for Q3 2024 was $661,769, a significant improvement from a net loss of $2.7 million in Q3 2023, reflecting a change of $3.35 million[134]. - The company does not expect to generate revenue from product candidates for several years, if at all[146]. - The company has incurred significant operating losses since inception and expects to continue doing so for the foreseeable future, raising substantial doubt about its ability to continue as a going concern[149]. Funding and Cash Flow - Ensysce requires substantial additional funding to support ongoing operations and growth strategy, expecting to finance through equity offerings, debt financings, or collaborations[99]. - The company generated gross proceeds of approximately $4.7 million from the exercise of warrants at a reduced exercise price of $1.31 per share[104]. - In August 2024, Ensysce agreed to issue 2,490,798 shares of common stock at an offering price of $0.47 per share, generating gross proceeds of approximately $1.67 million[108]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $9.8 million, compared to $7.3 million in the same period of 2023, mainly from a public offering and warrant exercises[151]. - The remaining cash funding under the MPAR federal research grant totaled $14 million as of September 30, 2024, expected to be utilized by May 31, 2027[148]. - Cash used in operating activities for the nine months ended September 30, 2024, was $6.7 million, a decrease from $9.0 million in the same period of 2023, primarily due to timing of vendor invoicing and reduced R&D activities[150]. - The net increase in cash and cash equivalents for the nine months ended September 30, 2024, was $3.0 million, compared to a decrease of $1.7 million in the same period of 2023[152]. - As of September 30, 2024, the company had $4.2 million in cash and cash equivalents, with expectations of continued operating losses for the foreseeable future[146]. Research and Development - The lead product candidate, PF614, is ready for Phase 3 clinical development, while PF614-MPAR is in Phase 1b and nafamostat has completed Phase 1 clinical development[96]. - Research and development expenses are expected to remain elevated due to ongoing and planned clinical trials for PF614, PF614-MPAR, and nafamostat[119]. - Research and development expenses for Q3 2024 were $1.7 million, down from $1.9 million in Q3 2023, representing a decrease of $0.2 million[136]. - Research and development expenses for the nine months ended September 30, 2024, were $3.4 million, down from $5.4 million in 2023, representing a decrease of $2 million[142]. - The company has not yet completed any pivotal clinical trials or obtained regulatory approvals for its product candidates[96]. - The company anticipates a substantial increase in expenses related to ongoing preclinical activities and clinical trials, as well as costs associated with operating as a public company[155]. Grants and Collaborations - The company has received federal grants from the NIH for the development of its MPAR® overdose prevention technology[113]. - Federal grant funding for Q3 2024 was $3.4 million, a significant increase from $0.4 million in Q3 2023, reflecting a change of $2.98 million[135]. - Federal grant funding for the nine months ended September 30, 2024, totaled $3.9 million, compared to $1.7 million for the same period in 2023, an increase of $2.19 million[141]. - The company may have to relinquish valuable rights to technologies or future revenue streams if it raises additional funds through collaborations[100]. Operating Expenses - General and administrative expenses for Q3 2024 were $1.1 million, a decrease of $0.1 million compared to $1.2 million in Q3 2023[137]. - Total operating expenses for Q3 2024 were $2.8 million, down from $3.1 million in Q3 2023, indicating a reduction of $0.37 million[134]. - General and administrative expenses for the nine months ended September 30, 2024, were $3.6 million, a decrease of $0.3 million from $3.9 million in 2023[143]. - As of September 30, 2024, the company had approximately $13.3 million in commitments related to open purchase orders and contractual obligations for research studies[156]. - The company expects future funding requirements to depend significantly on the progress and costs of research and development, regulatory reviews, and commercialization efforts[157].

Financial Performance - Net income attributable to common stockholders for Q3 2024 was $0.7 million, compared to a net loss of $2.7 million in Q3 2023, attributed to the timing of federal grant funding[12]. - The company expects net income for Q3 2024 to be a one-time event, with anticipated losses in future quarters due to ongoing R&D efforts[12]. - Total operating expenses for Q3 2024 were $2.8 million, down from $3.1 million in Q3 2023[10]. Grants and Funding - Ensysce received a $14 million multi-year NIH grant to support the clinical development of PF614-MPAR, allowing the initiation of a second Phase 1b trial[2]. - Federal grants totaled $3.4 million for Q3 2024, a significant increase from $0.4 million in the same quarter of 2023, due to increased research activities[9]. - Ensysce anticipates advancing its opioid use disorder program with the lead candidate PF9001, supported by a $15 million NIH grant[7]. Cash and Assets - Cash and cash equivalents increased to $4.2 million as of September 30, 2024, compared to $1.1 million as of December 31, 2023, driven by cumulative net proceeds of $8.5 million from equity financings[8]. - Total current assets increased to $9,090,507 in 2024 from $2,288,868 in 2023, representing a growth of approximately 297%[18]. - Cash and cash equivalents rose significantly to $4,153,592 in 2024, up from $1,123,604 in 2023, marking an increase of about 270%[18]. - Total assets increased to $9,384,724 in 2024 from $2,708,085 in 2023, showing a growth of around 247%[18]. Liabilities and Equity - Total liabilities decreased to $2,804,997 in 2024 from $3,359,352 in 2023, reflecting a reduction of approximately 16.5%[18]. - Current liabilities decreased to $2,801,784 in 2024 from $3,332,964 in 2023, a decline of approximately 15.9%[18]. - Long-term liabilities decreased significantly to $3,213 in 2024 from $26,388 in 2023, a reduction of about 87.8%[18]. - Stockholders' equity improved to $6,579,727 in 2024, compared to a deficit of $(651,267) in 2023, indicating a positive turnaround[18]. Research and Development - Research and development expenses were $1.7 million for Q3 2024, a decrease from $1.9 million in Q3 2023, primarily due to reduced external costs related to clinical programs[10]. - The company submitted the Phase 3 protocol for PF614 to the FDA, expecting feedback by the end of November 2024[2]. - The lead product PF614 is designed with Trypsin-Activated Abuse Protection (TAAP) technology, aimed at reducing opioid abuse and overdose risks[3]. Other Financial Metrics - Accounts payable slightly increased to $1,967,573 in 2024 from $1,936,007 in 2023, a rise of about 1.6%[18]. - Prepaid expenses and other current assets surged to $4,936,915 in 2024, up from $1,165,264 in 2023, an increase of approximately 323%[18]. - Accrued expenses and other liabilities decreased to $447,035 in 2024 from $542,260 in 2023, a decline of approximately 17.5%[18].

Core Insights - Ensysce Biosciences, Inc. has made significant advancements in its clinical programs and manufacturing partnerships in the first half of 2024, particularly with the PF614 Phase 3 clinical trial and the PF614-MPAR program receiving Breakthrough Therapy designation from the FDA [1][5][6] Business Model and Services - Ensysce focuses on developing prescription drugs for severe pain relief, utilizing innovative technologies such as Trypsin Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR™) [7] Industry Developments - The opioid use disorder (OUD) program has identified PF9001 as the lead candidate, which shows lower cardiovascular side effects compared to traditional methadone, supported by a $15 million NIDA HEAL award [2] Financial Results - As of the end of H1 2024, Ensysce had cash reserves of $1.04 million, with total operating cash burn decreasing to $5.7 million from $6.7 million year-over-year [4] - Operating expenses for Q2 2024 were $2.14 million, down from $2.78 million in Q2 2023, primarily due to reduced research and development costs [4] Valuation - The valuation of Ensysce is reiterated at $8.00 per share, contingent on successful execution of its clinical programs and advancements in its pipeline candidates [3]

Financial Performance - Cash and cash equivalents were $1.0 million as of June 30, 2024, down from $1.1 million as of December 31, 2023[6] - Federal grants funding totaled $0.2 million for Q2 2024, compared to $0.5 million in the same quarter of 2023, due to the completion of funding under the MPAR grant[6] - Net loss attributable to common stockholders for Q2 2024 was $2.0 million, compared to $2.2 million in Q2 2023[7] - Total operating expenses for Q2 2024 were $2.1 million, down from $2.8 million in Q2 2023[6] - Total liabilities decreased to $1.3 million in 2024 from $3.4 million in 2023, while stockholders' equity improved to $1.5 million from a deficit of $0.7 million[13] Research and Development - Research and development expenses decreased to $0.9 million in Q2 2024 from $1.6 million in Q2 2023, a reduction of $0.7 million[6] - The PF614 Phase 3 clinical trial is on track to initiate in the second half of 2024, with the protocol design being finalized[2] - The lead drug candidate for the Opioid Use Disorder program, PF9001, has been selected and is supported by a multi-year NIH award of up to $15 million[5] - The upcoming Phase 1b study, PF614-MPAR-102, will test multiple PF614-MPAR drug products for overdose protection and effective delivery of oxycodone[4] Administrative Expenses - General and administrative expenses were $1.2 million in Q2 2024, slightly up from $1.1 million in Q2 2023[6]

Financial Performance - Ensysce Biosciences has not generated any revenue from product sales since its inception and does not expect to do so in the near future[84]. - The company has incurred significant operating losses since inception and expects to continue incurring net losses for the foreseeable future[86]. - Net loss for the three months ended June 30, 2024, was $2.0 million, an improvement of $0.3 million compared to a net loss of $2.2 million in 2023[113]. - Net cash used in operating activities for the six months ended June 30, 2024, was $5.7 million, compared to $6.7 million in 2023, a decrease of $1.0 million[129]. - As of June 30, 2024, the company had $1.0 million in cash and cash equivalents, indicating limited liquidity and ongoing operating losses[125]. Research and Development - The lead product candidate, PF614, is ready for Phase 3 clinical development, while PF614-MPAR is in Phase 1b and nafamostat has completed Phase 1 clinical development[85]. - Ensysce anticipates substantial expenses related to ongoing development activities, including preclinical studies and clinical trials for its product candidates[89]. - The company does not track research and development expenses on a program-by-program basis, making it difficult to estimate costs for specific product candidates[98]. - Research and development expenses for the three months ended June 30, 2024, were $0.9 million, down from $1.6 million in 2023, representing a decrease of $0.7 million[115]. - Research and development expenses for the six months ended June 30, 2024, were $1.7 million, a decrease of $1.7 million from $3.4 million in 2023[121]. - The company expects a substantial increase in operating expenses due to ongoing research and development activities, particularly in preclinical and clinical trials[133]. - As of June 30, 2024, the company has approximately $16 million in commitments related to open purchase orders and contractual obligations for preclinical and clinical research studies[134]. Funding and Capital Requirements - The company requires substantial additional funding to support operations and pursue its growth strategy, which may involve dilution of existing ownership interests[86]. - Ensysce's future viability is dependent on its ability to raise additional capital to finance operations[88]. - The company raised approximately $4.7 million from the exercise of warrants at a reduced price of $1.31 per share[90]. - Future funding requirements may increase significantly based on the scope and costs of research, regulatory reviews, and manufacturing capabilities[135]. Expenses and Grants - General and administrative expenses are expected to increase as the company expands its headcount to support product development[104]. - Federal grant funding for the three months ended June 30, 2024, was $0.2 million, a decrease of $0.3 million from $0.5 million in the same period of 2023[114]. - Federal grant funding for the six months ended June 30, 2024, totaled $0.5 million, down from $1.3 million in 2023, a decrease of $0.8 million[120]. - General and administrative expenses for the three months ended June 30, 2024, were $1.2 million, an increase of $0.1 million from $1.1 million in 2023[116]. - Total operating expenses for the three months ended June 30, 2024, were $2.1 million, a decrease of $0.6 million from $2.8 million in 2023[113]. - Total operating expenses for the six months ended June 30, 2024, were $4.3 million, down from $6.1 million in 2023, a decrease of $1.8 million[119]. Company Classification and Market Conditions - The company is classified as a "smaller reporting company," allowing for reduced disclosure obligations until certain market value or revenue thresholds are met[142]. - Cash and cash equivalents as of June 30, 2024, consist of cash and a money market fund account, with minimal impact expected from changes in market interest rates[143]. - Inflation and changing prices have not significantly impacted the company's results of operations for the periods presented[144].

Financial Performance - Cash and cash equivalents increased to $3.4 million as of March 31, 2024, up from $1.1 million as of December 31, 2023[8] - Net loss attributable to common stockholders for Q1 2024 was $3.1 million, compared to a net loss of $2.2 million in Q1 2023, representing an increase of approximately 41%[12] - Total operating expenses for Q1 2024 were $2.1 million, down from $3.4 million in Q1 2023, a decrease of about 36%[18] - Federal grants funding totaled $0.3 million in Q1 2024, down from $0.8 million in the same quarter of the previous year due to the completion of funding under the MPAR grant[9] - The company received cash proceeds of $2.1 million from warrant exercises in January 2024 and $4.7 million in February 2024 from additional warrant exercises[8] - Total assets increased to $5.1 million as of March 31, 2024, compared to $2.7 million as of December 31, 2023[22] Expenses - Research and Development (R&D) expenses decreased to $0.8 million in Q1 2024 from $1.8 million in Q1 2023, a reduction of approximately 56%[9] - General and Administrative (G&A) expenses were $1.4 million in Q1 2024, down from $1.6 million in Q1 2023, a decrease of about 13%[10] Clinical Development - The FDA granted Breakthrough Therapy designation for PF614-MPAR, which is intended to expedite the development of this innovative opioid product[6] - Ensysce plans to initiate Phase 3 clinical trials for PF614 in the second half of 2024, following positive guidance from the FDA[2]

Financial Performance - Ensysce has incurred significant operating losses since its inception and expects to continue incurring net losses for the foreseeable future[102]. - The company has not generated any revenue from product sales and may never be able to commercialize a marketable product[100]. - Net loss for Q1 2024 was $3.1 million, compared to a net loss of $2.2 million in Q1 2023, an increase of $0.9 million[137]. - Cash and cash equivalents as of March 31, 2024, were $3.4 million, with significant operating losses anticipated to continue[142]. - Net cash used in operating activities for Q1 2024 was $3.4 million, slightly down from $3.6 million in Q1 2023[147]. - General and administrative expenses for Q1 2024 were $1.4 million, down from $1.6 million in Q1 2023, reflecting a decrease of $0.2 million[140]. - Research and development expenses decreased to $0.8 million in Q1 2024 from $1.8 million in Q1 2023, a reduction of $1.0 million primarily due to lower external costs[139]. Funding and Financing - Ensysce completed a public offering on May 12, 2023, raising approximately $7.0 million before costs by selling 1,800,876 shares at $3.887 each[110]. - The company entered into a Securities Purchase Agreement on October 23, 2023, for $1.7 million in financing, with a 6.0% annual interest rate and an 8% original issue discount[113]. - Net cash provided by financing activities in Q1 2024 was $5.7 million, compared to $1.9 million in Q1 2023, indicating increased financing activity[148]. - The company may finance operations through private and public equity offerings, debt financings, or collaborations, which could dilute existing ownership interests[104]. - Remaining funding under two approved federal research grants totaled $1.9 million as of March 31, 2024, expected to be utilized by August 31, 2024[144]. - Federal grant funding for Q1 2024 was $0.3 million, down from $0.8 million in Q1 2023, due to the completion of current funding under the MPAR grant[138]. 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[101]. - Ensysce expects substantial expenses for ongoing development and commercialization of product candidates, requiring significant additional funding[108]. - Research and development expenses are expected to remain elevated due to ongoing and planned clinical trials for PF614, PF614-MPAR, and nafamostat[124]. - The company is unable to estimate the exact amount of its working capital requirements due to numerous risks and uncertainties associated with research, development, and commercialization of biologic product candidates[154]. - Future funding requirements could increase significantly based on factors such as the costs of clinical trials and regulatory reviews[154]. Going Concern and Operational Risks - Ensysce has limited revenue generation and substantial doubt exists about its ability to continue as a going concern without raising additional capital[107]. - The company expects to continue incurring significant expenses and operating losses for the foreseeable future, raising doubts about its ability to continue as a going concern[145]. - Commitments as of March 31, 2024, included an estimated $17.6 million related to open purchase orders and contractual obligations[153]. - The company has no off-balance sheet arrangements during the periods presented[158]. Market and Economic Conditions - The company is classified as a "smaller reporting company," which allows it to provide reduced disclosure obligations until certain market value or revenue thresholds are met[160]. - Cash and cash equivalents as of March 31, 2024, consisted of cash and a money market fund account, with no expected material impact from sudden changes in market interest rates[162]. - Inflation and changing prices are not believed to have significantly impacted the company's results of operations for any periods presented[163].

As filed with the Securities and Exchange Commission on March 26, 2024 Registration No. 333-276537 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) Delaware 2834 82-2755287 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer ...

Financial Performance - The company has not generated any revenue from product sales since its inception in 2003 and may never commercialize a marketable product [346]. - The Company has not generated significant revenue and does not expect to do so in the near future [374]. - Federal grants revenue decreased to $2.2 million in 2023 from $2.5 million in 2022, a decline of $0.3 million due to timing of research activities [400]. - The net loss for 2023 was $10.6 million, an improvement of $13.6 million compared to a net loss of $24.2 million in 2022 [399]. - Cash used in operating activities was $10.8 million in 2023, a decrease from $17.9 million in 2022, reflecting improved cash flow management [418]. - As of December 31, 2023, the company had $1.1 million in cash and cash equivalents, with an accumulated deficit of $121.6 million [405][414]. - The company expects to continue incurring significant operating losses for the foreseeable future without additional capital [414]. Funding and Capital Requirements - The company requires substantial additional funding to support ongoing operations and growth strategies, with current cash expected to last until Q3 2024 [350][353]. - Ensysce completed a public offering on May 12, 2023, raising approximately $7.0 million before fees by selling 1,800,876 shares at a combined price of $3.887 per share [367]. - The company entered into an $8.0 million convertible financing agreement in June 2022, with gross cash proceeds of $4.0 million from two closings [357]. - The Company entered into a Securities Purchase Agreement for an aggregate financing of $1.7 million, including $0.2 million from a board member [371]. - Future funding requirements will depend on the advancement of clinical trials and the ability to raise additional capital [406][422]. - Remaining funding under approved federal research grants totals $2.2 million, expected to be utilized by August 2024 [407]. - The company has commitments of approximately $17.9 million related to open purchase orders and contractual obligations for research studies [423]. Research and Development - Ensysce's lead product candidate, PF614, is currently in Phase 2 clinical development, while PF614-MPAR is in Phase 1b, and nafamostat is moving towards Phase 2 [347]. - Ensysce has not yet completed any pivotal clinical trials or obtained regulatory approvals for its product candidates [347]. - The company plans to continue preclinical studies and initiate new clinical trials for its lead product candidates, while also expanding its intellectual property portfolio [349]. - Research and development expenses are expected to remain elevated due to ongoing clinical trials for product candidates, including PF614 and nafamostat [380]. - The company is currently focused on the research and development of product candidates, including preclinical and clinical trials, with associated costs and timelines being critical factors [425]. - The company estimates accrued research and development expenses based on contracts and services performed, which may lead to variations in reported amounts [428]. Operating Expenses - The company has incurred significant operating losses and expects to continue doing so for the foreseeable future, raising doubts about its ability to continue as a going concern [348][353]. - The company has incurred additional costs associated with operating as a public entity, including legal, accounting, and investor relations expenses [348]. - General and administrative expenses are anticipated to increase as the Company expands its headcount to support product development [385]. - General and administrative expenses decreased to $5.4 million in 2023 from $6.9 million in 2022, a decrease of $1.5 million attributed to reduced stock-based compensation and other costs [402]. Tax and Valuation - The Company maintains a full valuation allowance against all deferred tax assets due to uncertainty in generating future taxable income [395]. - The company recorded a loss on the issuance of convertible notes, reflecting the difference between gross proceeds and calculated fair value [386]. Market and Economic Conditions - The company does not believe inflation significantly impacted its results of operations for the periods presented [435]. - The company qualifies as a "smaller reporting company," allowing it to provide reduced disclosure obligations until certain market value or revenue thresholds are exceeded [432]. - As of December 31, 2023, the company's cash and cash equivalents included cash and a money market fund account, with minimal impact expected from changes in market interest rates [434].

Financial Performance - Ensysce reported a net loss of $3.5 million for Q4 2023, a decrease from $5.5 million in Q4 2022, and a full-year net loss of $10.6 million compared to $25.1 million in 2022[15]. - Cash and cash equivalents decreased to $1.1 million as of December 31, 2023, down from $1.5 million as of September 30, 2023[10]. - Total operating expenses for Q4 2023 were $3.7 million, a decrease from $7.6 million in Q4 2022, with full-year operating expenses at $12.9 million compared to $26.7 million in 2022[18]. - Federal grants funding totaled $0.5 million in Q4 2023, down from $1.4 million in the same quarter of 2022, with full-year funding at $2.2 million compared to $2.5 million in 2022[11]. - Ensysce's total assets decreased to $2.7 million as of December 31, 2023, from $5.9 million a year earlier[22]. - The company’s total liabilities were $3.4 million as of December 31, 2023, down from $9.9 million in 2022[22]. Research and Development - Research and development expenses for Q4 2023 were $2.2 million, significantly lower than $6.4 million in Q4 2022, with full-year R&D expenses at $7.6 million compared to $19.8 million in 2022[12]. - Ensysce received FDA Breakthrough Therapy designation for PF614-MPAR in January 2024, which is a significant milestone for the company's clinical programs[8]. - The company expects to initiate enrollment for the Phase 3 clinical trial of PF614 in the second half of 2024, following positive FDA guidance[2]. - Ensysce's product candidates are currently in clinical trials and have not yet received regulatory approval[26]. - The company emphasizes the importance of regulatory submissions and approvals for its product candidates[26]. Risks and Uncertainties - The company acknowledges potential risks and uncertainties that may affect the success of its clinical programs[26]. - Ensysce's management believes that their estimates and assumptions are reasonable, but they remain inherently uncertain[26]. - The company is subject to risks related to the initiation and conduct of preclinical studies and clinical trials[26]. - Ensysce's ability to fund its continued operations, including planned clinical trials, is a significant concern[26]. - The potential dilutive effect of stock issuances from fundraising activities is noted[26]. - Ensysce's forward-looking statements are based on management's expectations and are subject to change[26]. - The company has no obligation to publicly update or revise any forward-looking statements unless required by law[26]. Funding and Capital - The company received $2.1 million from warrant exercises after year-end and an additional $4.7 million from warrant exercises in February 2024[10].