Ensysce Biosciences(ENSC) - 2025 Q1 - Quarterly Results

Operational Highlights & Strategic Outlook CEO Commentary & Strategic Outlook The CEO highlighted significant Q1 progress in developing next-generation opioid analgesics, securing a U.S. patent for PF9001, and confirming overdose protection for PF614-MPAR - Received a Notice of Allowance from the U.S. Patent and Trademark Office for the lead opioid use disorder (OUD) drug candidate, PF9001, expanding its portfolio to over 100 patents across 25 countries[2] - Completed enrollment for Part 1 of the PF614-MPAR-102 clinical study, which confirmed protection from overdose risk when PF614-MPAR is consumed in excessive doses[2] - The company's mission is to use its proprietary chemistry to deliver novel opioid analgesics with both abuse (TAAP) and overdose (MPAR) protection, aiming to save lives and reshape the approach to pain and addiction[2] Clinical Program Updates The company is advancing its TAAP, MPAR®, and OUD programs, preparing for a Phase 3 trial for PF614, confirming overdose protection for PF614-MPAR, and securing a key patent for PF9001 TAAP™ (Opioid Abuse Deterrent Program) Update The lead TAAP™ product, PF614, an extended-release oxycodone, is designed to deter non-oral abuse and is preparing for a Phase 3 clinical trial in mid-2025 - PF614's Trypsin-Activated Abuse Protection (TAAP) technology makes the oxycodone inactive until it is swallowed and activated by trypsin in the small intestine, designed to control release and resist tampering[3] - The company plans to initiate the Phase 3 PF614-301 clinical study in mid-2025, following receipt of FDA feedback in December 2024[4] MPAR® (Opioid Abuse Deterrent and Overdose Protection Program) Update The PF614-MPAR program, combining TAAP™ with MPAR® for overdose protection, received FDA Breakthrough Therapy designation and confirmed overdose protection in its latest clinical trial, now proceeding to Part 2 - PF614-MPAR combines the TAAP prodrug (PF614) with a trypsin inhibitor (MPAR®) to "switch off" the release of the opioid in an overdose situation[5] - The program received FDA's Breakthrough Therapy designation in January 2024 based on initial clinical trial data[5] - Completed Part 1 of the PF614-MPAR-102 clinical trial, confirming overdose protection at higher doses. The study has now progressed to Part 2 to examine food effects[6] Opioid Use Disorder (OUD) Program Update The OUD program is developing PF9001, a safer methadone analogue with overdose protection and reduced cardiovascular side effects, securing a U.S. patent and advancing toward non-clinical studies for a future IND application - The lead OUD drug candidate, PF9001, is a methadone analogue designed with TAAP and MPAR® technology for safer treatment, aiming for reduced cardiovascular side effects and overdose protection[7] - Secured a U.S. patent titled "Enzyme-Cleavable Methadone Prodrugs and Methods of Use Thereof," which covers the composition and use of PF9001[8] - The program is supported by a multi-year Helping to End Addiction Long-Term (HEAL) award and is planned to continue to non-clinical studies for a future IND submission[7] Financial Performance Q1 2025 Financial Results Summary Ensysce reported a reduced net loss of $1.9 million in Q1 2025, driven by increased federal grant funding and favorable other income, despite higher R&D expenses, ending the quarter with $3.1 million in cash Q1 2025 Financial Highlights | Financial Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Net Loss | $1.9 million | $3.1 million | Decreased Loss | | Federal Grants | $1.3 million | $0.3 million | +$1.0 million | | R&D Expenses | $1.9 million | $0.8 million | +$1.1 million | | G&A Expenses | $1.4 million | $1.4 million | Unchanged | | Cash & Equivalents (at quarter end) | $3.1 million | $3.4 million | -$0.3 million | - Cash and cash equivalents were $3.1 million as of March 31, 2025. Subsequent to the quarter's end, the company received gross proceeds of $2.2 million from the exercise of warrants[9] - The increase in R&D expenses was primarily the result of external research and development costs related to PF614-MPAR, with increased pre-clinical activity in the 2025 period[11] Condensed Consolidated Financial Statements The unaudited financial statements for the quarter ended March 31, 2025, detail the company's financial position, showing a net loss of $1.9 million, total assets of $4.6 million, and net cash used in operations of $1.7 million Condensed Consolidated Statements of Operations For the three months ended March 31, 2025, Ensysce reported a net loss of $1.95 million, a significant improvement from $3.12 million in the prior-year period, driven by increased federal grant revenue and a positive swing in other income Statements of Operations Summary | (in USD) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Federal grants | $1,319,772 | $305,722 | | Research and development | $1,885,528 | $778,904 | | General and administrative | $1,401,756 | $1,369,782 | | Loss from operations | $(1,967,512) | $(1,842,964) | | Net loss | $(1,945,573) | $(3,116,563) | | Net loss per share, basic and diluted | $(1.39) | $(8.21) | Condensed Consolidated Statements of Cash Flows For the three months ended March 31, 2025, net cash used in operating activities was $1.7 million, a significant reduction from the prior year, resulting in a net decrease in cash of $0.45 million and an ending cash balance of $3.1 million Statements of Cash Flows Summary | (in USD) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,707,412) | $(3,408,403) | | Net cash provided by financing activities | $1,257,826 | $5,689,148 | | Change in cash and cash equivalents | $(449,586) | $2,280,745 | | Cash and cash equivalents at end of period | $3,052,491 | $3,404,349 | Condensed Consolidated Balance Sheets As of March 31, 2025, Ensysce had total assets of $4.6 million and total liabilities of $1.9 million, resulting in stockholders' equity of $2.7 million, primarily reflecting decreases in cash and accounts payable Balance Sheets Summary | (in USD) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $3,052,491 | $3,502,077 | | Total current assets | $4,400,991 | $5,344,682 | | Total assets | $4,611,874 | $5,597,232 | | Liabilities and Equity | | | | Total current liabilities | $1,761,176 | $2,207,197 | | Total liabilities | $1,891,356 | $2,217,293 | | Stockholders' equity | $2,720,518 | $3,379,939 |