Ensysce Biosciences(ENSC) - 2024 Q4 - Annual Results

Operational and Strategic Highlights Ensysce Biosciences made significant operational progress in Q4 2024, securing a strategic partnership and advancing lead drug candidates with positive clinical results and FDA feedback TAAP™ (Opioid Abuse Deterrent Program) Update PF614, utilizing TAAP™ technology, is designed as a tamper-resistant opioid, with a strategic manufacturing partnership established for its commercial launch - PF614 is a TAAP™ extended-release oxycodone that is chemically modified to be inactive until exposed to trypsin in the small intestine, designed to reduce abuse[4] - A strategic partnership was formed with a specialty drug manufacturer to prepare for the commercial supply and launch of PF614[5] MPAR™ (Opioid Abuse Deterrent and Overdose Protection Program) Update PF614-MPAR, combining TAAP™ with overdose protection, received FDA Breakthrough Therapy designation and showed positive interim results in clinical trials - PF614-MPAR combines the TAAP™ prodrug with a trypsin inhibitor to reduce opioid release in an overdose scenario, providing an additional layer of safety[6] - The MPAR™ technology received FDA Breakthrough Therapy designation in January 2024 following positive data from the initial PF614-MPAR-101 trial[6] - Interim data from the second clinical trial (PF614-MPAR-102) demonstrated that a 100 mg dosage form provided overdose protection when multiple doses were consumed at once[7] Opioid Use Disorder (OUD) Program Update Ensysce is developing TAAP™-based methadone analogues, with PF9001 as the lead candidate, to treat OUD by reducing abuse potential and side effects, supported by a HEAL award - The company selected PF9001 as its lead drug candidate for treating Opioid Use Disorder (OUD) in 2024[8] - The OUD program aims to create a safer methadone alternative by reducing abuse potential and cardiovascular side effects, making treatment more accessible[8] - The program is supported by a multi-year Helping to End Addiction Long-Term (HEAL) award and is advancing through non-clinical studies[8] - Secured a strategic partnership with a leading specialty drug manufacturer for the future commercial production of PF614 and PF614-MPAR[3][5] - Received FDA feedback on the PF614 Phase 3 study design, with enrollment expected to begin in Q2 2025 and a New Drug Application (NDA) submission targeted for 2026[3] - Reported positive interim results from the PF614-MPAR-102 study, showing the drug provides overdose protection when a greater-than-prescribed dose is consumed[3][7] Q4 & Full Year 2024 Financial Results Ensysce reported a reduced net loss in FY2024, driven by increased federal grant funding and decreased operating expenses, ending the year with a strengthened cash position Full Year 2024 vs. 2023 Financial Highlights | Financial Metric | FY 2024 | FY 2023 | Change | | :--- | :--- | :--- | :--- | | Federal Grants | $5.2 million | $2.2 million | +136% | | R&D Expenses | $7.2 million | $7.6 million | -5% | | G&A Expenses | $4.7 million | $5.4 million | -13% | | Net Loss | ($8.0 million) | ($10.6 million) | +25% (Loss Reduced) | | Cash at Year-End | $3.5 million | $1.1 million | +214% | - Cash and cash equivalents were $3.5 million as of December 31, 2024, compared to $1.1 million as of December 31, 2023. Cash from financing activities ($9.9 million) exceeded cash used in operations ($7.5 million) for the year[9] - The increase in federal grant funding is largely due to a $14 million multi-year award from the National Institute on Drug Abuse (NIDA) to support the MPAR clinical program[10] Consolidated Financial Statements This section presents Ensysce Biosciences' unaudited condensed consolidated financial statements, including Statements of Operations, Cash Flows, and Balance Sheets, for 2024 and 2023 Condensed Consolidated Statements of Operations For FY2024, the company reported a reduced net loss of $8.0 million or ($11.45) per share, driven by increased federal grant revenue and decreased operating expenses Condensed Consolidated Statements of Operations | | Year Ended December 31, | | Three Months Ended Dec 31, | | | :--- | :--- | :--- | :--- | :--- | | | 2024 ($) | 2023 ($) | 2024 ($) | 2023 ($) | | Federal grants | 5,210,031 | 2,230,520 | 1,303,659 | 515,032 | | Total operating expenses | 11,940,165 | 12,948,707 | 4,880,135 | 3,670,717 | | Loss from operations | (6,730,134) | (10,718,187) | (3,576,476) | (3,155,685) | | Net loss | (7,987,009) | (10,626,275) | (3,564,422) | (3,504,361) | | Net loss per share | (11.45) | (70.40) | (2.90) | (16.94) | Condensed Consolidated Statements of Cash Flows Net cash used in operating activities was $7.5 million in FY2024, offset by $9.9 million from financing, resulting in a $2.4 million net cash increase and a $3.5 million year-end balance Condensed Consolidated Statements of Cash Flows (Year Ended December 31) | | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | (7,502,700) | (10,779,982) | | Net cash provided by financing activities | 9,881,173 | 8,755,884 | | Change in cash and cash equivalents | 2,378,473 | (2,024,098) | | Cash and cash equivalents at beginning of period | 1,123,604 | 3,147,702 | | Cash and cash equivalents at end of period | 3,502,077 | 1,123,604 | Condensed Consolidated Balance Sheets As of December 31, 2024, Ensysce's balance sheet strengthened with total assets doubling to $5.6 million, liabilities decreasing, and stockholders' equity turning positive to $3.4 million Condensed Consolidated Balance Sheets (As of December 31) | | 2024 ($) | 2023 ($) | | :--- | :--- | :--- | | Total current assets | 5,344,682 | 2,288,868 | | Total assets | 5,597,232 | 2,708,085 | | Total current liabilities | 2,207,197 | 3,332,964 | | Total liabilities | 2,217,293 | 3,359,352 | | Stockholders' deficit/equity | 3,379,939 | (651,267) |