Core Insights - Ensysce Biosciences is developing safer opioids using "clever chemistry" to reduce the risks of accidental overdose and abuse [1][4][5] - The opioid crisis remains a significant issue, with approximately 3 million patients annually relying on opioids for pain management, leading to nearly one trillion dollars in economic costs to the healthcare industry [3][6] - Ensysce's modified oxycodone has received FDA "Fast Track" and "Breakthrough Therapy" designations, indicating a recognized medical need and expedited availability [6] Company Overview - Ensysce Biosciences focuses on innovative oral drug delivery solutions, utilizing proprietary technologies like TAAP™ and MPAR® to enhance patient safety by preventing abuse and overdose [8][9] - The company aims to address the dual crises of opioid pain treatment needs and regulatory restrictions on opioid use, positioning itself as a potential solution to this impasse [7] Industry Context - The pharmaceutical industry has invested heavily in alternative painkillers without success, while Ensysce's approach involves re-engineering opioids to ensure they are safer for prescription [4][5] - The ongoing opioid crisis highlights the necessity for effective pain management solutions that minimize health risks, making Ensysce's innovations particularly relevant [3][6]

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].

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].