Ensysce Biosciences(ENSC) - 2025 Q2 - Quarterly Results

Executive Summary & Q2 2025 Highlights Ensysce Biosciences reported strong Q2 2025 results, advancing opioid therapy programs with a pivotal Phase 3 trial and NIDA funding Q2 2025 Highlights and Strategic Outlook Ensysce Biosciences reported Q2 2025 financial and operational results, highlighting significant progress in its opioid therapy programs, including a pivotal Phase 3 trial and NIDA funding - Initiated pivotal Phase 3 trial for PF614, a critical step towards regulatory approval for next-generation opioid therapy[1][2] - Completed full enrollment for Part 2 of the PF614-MPAR-102 study, advancing the overdose-protection product[1][2] - Received a $5.3 million installment from NIDA, supporting the overdose protection program[1][8] - CEO emphasizes momentum in developing opioid therapeutics with built-in safety features against misuse and overdose, aiming to reshape the opioid treatment landscape[2] Program Updates Ensysce updates on TAAP, MPAR, and OUD programs, highlighting clinical progress, regulatory designations, and IP TAAP (Opioid Abuse Deterrent Program) Update Ensysce's lead product, PF614, an extended-release oxycodone utilizing Trypsin-Activated Abuse Protection (TAAP) technology, is designed to be inactive until swallowed, reducing abuse potential - PF614 is a Trypsin-Activated Abuse Protection (TAAP) extended-release oxycodone, designed to be inactive until swallowed and exposed to trypsin, controlling release and resisting tampering[3] - Initiated the pivotal PF614-301 study in July 2025 to evaluate PF614 for managing severe post-surgical pain after abdominoplasty, aiming to demonstrate effectiveness and minimize abuse risk[4] - Engaged Rho, Inc., a clinical research organization, to conduct the PF614-301 trial, marking a major step toward redefining pain therapy[4] MPAR® (Opioid Abuse Deterrent and Overdose Protection Program) Update PF614-MPAR combines TAAP and Multi-Pill Abuse Resistance (MPAR®) technologies, offering oral overdose protection and received FDA Breakthrough Therapy designation in January 2024 - PF614-MPAR combines TAAP and MPAR® technologies, incorporating a trypsin inhibitor to reduce opioid release in overdose situations, providing oral overdose protection[5] - Received FDA Breakthrough Therapy designation in January 2024 for PF614-MPAR due to its potential to prevent overdose while maintaining pain relief[5][6] - Completed Part 2 enrollment for the PF614-MPAR-102 study in Q2 2025, examining food effects on MPAR technology, with Part 3 continuing through year-end[6] - The program is supported by a multi-year NIDA grant[6] OUD Program Update Ensysce is developing innovative treatments for opioid use disorder (OUD), leveraging its TAAP™ and MPAR® technologies to create a potentially safer methadone alternative - Advancing innovative treatments for opioid use disorder (OUD), including novel compounds designed to reduce cravings and prevent relapse[7] - Selected PF9001 as its lead OUD candidate in 2024, evaluating it for oral delivery, reduced cardiovascular risk, and built-in overdose protection[7] - The OUD program is supported by a multi-year HEAL (Helping to End Addiction Long-Term) grant from NIDA[7] - Received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent covering the composition and use of PF9001 patent, strengthening intellectual property[7] Q2 2025 Financial Results Overview Ensysce's Q2 2025 financials show decreased cash, increased federal grants and R&D, and a reduced net loss Cash and Federal Grants As of June 30, 2025, cash and cash equivalents were $2.2 million, down from $3.5 million at December 31, 2024, with federal grant funding significantly increasing due to clinical activities Cash and Cash Equivalents | Metric | June 30, 2025 ($ million) | December 31, 2024 ($ million) | | :----- | :------------------------ | :---------------------------- | | Cash and cash equivalents | $2.2 | $3.5 | - Received the second $5.3 million installment of a $15 million, three-year grant from NIDA, available for R&D expenses under the MPAR program through May 2026[8] Federal Grants Funding (Three Months Ended June 30) | Period | 2025 ($ million) | 2024 ($ million) | | :----- | :--------------- | :--------------- | | Federal grants | $1.4 | $0.2 | - The increase in federal grants funding is due to the timing of research activities, with increased clinical activities in 2025 for the PF614-MPAR-102 study[9] Operating Expenses Research and Development (R&D) expenses increased significantly to $1.9 million in Q2 2025 from $0.9 million in Q2 2024, while General and Administrative (G&A) expenses remained constant Research & Development Expenses (Three Months Ended June 30) | Period | 2025 ($ million) | 2024 ($ million) | | :----- | :--------------- | :--------------- | | R&D expenses | $1.9 | $0.9 | - The increase in R&D expenses was primarily due to external research and development costs related to PF614-MPAR, with increased pre-clinical and clinical activity[10] General & Administrative Expenses (Three Months Ended June 30) | Period | 2025 ($ million) | 2024 ($ million) | | :----- | :--------------- | :--------------- | | G&A expenses | $1.2 | $1.2 | Net Income (Loss) The net loss attributable to common stockholders for Q2 2025 was $1.7 million, an improvement from a net loss of $2.0 million in Q2 2024, with a net loss per share of $(0.79) Net Loss Attributable to Common Stockholders (Three Months Ended June 30) | Period | 2025 ($ million) | 2024 ($ million) | | :----- | :--------------- | :--------------- | | Net loss | $(1.7) | $(2.0) | Net Loss Per Share (Basic and Diluted, Three Months Ended June 30) | Period | 2025 ($) | 2024 ($) | | :----- | :------- | :------- | | Net loss per share | $(0.79) | $(3.35) | - As a clinical-stage biotech company, continued research and development efforts are expected to result in losses for the foreseeable future[12] Company Information This section overviews Ensysce Biosciences, its mission, and definitions of its core TAAP and MPAR technologies About Ensysce Biosciences Ensysce Biosciences is a clinical-stage pharmaceutical company focused on developing innovative solutions for severe pain relief while reducing opioid abuse and overdose - Ensysce Biosciences is a clinical-stage company aiming to disrupt the analgesic landscape with a new class of highly novel opioids for severe pain[14] - Utilizes Trypsin-Activated Abuse Protection (TAAP) and Multi-Pill Abuse Resistance (MPAR) platforms to develop unique, tamper-proof treatment options[14] - Mission is to provide safer options for patients with severe pain and prevent deaths caused by medication abuse[14] Definitions This section provides concise definitions for the core technologies developed by Ensysce Biosciences: TAAP (Trypsin Activated Abuse Protection) and MPAR (Multi-Pill Abuse Resistance) - TAAP (Trypsin Activated Abuse Protection) is designed to protect against prescription drug abuse[15] - MPAR (Multi-Pill Abuse Resistance) is designed to protect against abuse and accidental overdose[16] Financial Statements This section presents Ensysce Biosciences' condensed consolidated statements of operations, cash flows, and balance sheets Condensed Consolidated Statements of Operations The Condensed Consolidated Statements of Operations provide a detailed breakdown of Ensysce Biosciences' revenues and expenses for the three and six months ended June 30, 2025, and 2024 Condensed Consolidated Statements of Operations (Three Months Ended June 30) | Item | Q2 2025 ($) | Q2 2024 ($) | | :----------------------------------- | :---------- | :---------- | | Federal grants | $1,371,438 | $181,797 | | Research and development | $1,923,430 | $947,229 | | General and administrative | $1,198,523 | $1,190,010 | | Total operating expenses | $3,121,953 | $2,137,239 | | Loss from operations | $(1,750,515) | $(1,955,442) | | Total other income (expense), net | $16,998 | $(12,351) | | Net loss | $(1,733,517) | $(1,967,793) | | Net loss attributable to common stockholders | $(1,733,351) | $(1,967,793) | | Net loss per share, basic and diluted | $(0.79) | $(3.35) | Condensed Consolidated Statements of Operations (Six Months Ended June 30) | Item | H1 2025 ($) | H1 2024 ($) | | :----------------------------------- | :---------- | :---------- | | Federal grants | $2,691,210 | $487,519 | | Research and development | $3,808,957 | $1,726,133 | | General and administrative | $2,600,279 | $2,559,791 | | Total operating expenses | $6,409,236 | $4,285,924 | | Loss from operations | $(3,718,026) | $(3,798,405) | | Total other income (expense), net | $38,936 | $(1,285,951) | | Net loss | $(3,679,090) | $(5,084,356) | | Net loss attributable to common stockholders | $(3,678,924) | $(5,084,572) | | Net loss per share, basic and diluted | $(2.04) | $(9.98) | Condensed Consolidated Statements of Cash Flows The Condensed Consolidated Statements of Cash Flows detail the cash movements for the six months ended June 30, 2025, and 2024, showing a decrease in cash and cash equivalents Condensed Consolidated Statements of Cash Flows (Six Months Ended June 30) | Item | H1 2025 ($) | H1 2024 ($) | | :-------------------------------- | :---------- | :---------- | | Net cash used in operating activities | $(4,414,280) | $(5,718,294) | | Net cash provided by financing activities | $3,123,778 | $5,637,921 | | Change in cash and cash equivalents | $(1,290,502) | $(80,373) | | Cash and cash equivalents at beginning of period | $3,502,077 | $1,123,604 | | Cash and cash equivalents at end of period | $2,211,575 | $1,043,231 | Condensed Consolidated Balance Sheets The Condensed Consolidated Balance Sheets present Ensysce Biosciences' financial position as of June 30, 2025, compared to December 31, 2024, showing a slight decrease in total assets and stockholders' equity Condensed Consolidated Balance Sheets | Item | June 30, 2025 ($) | December 31, 2024 ($) | | :----------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $2,211,575 | $3,502,077 | | Total current assets | $5,281,595 | $5,344,682 | | Total assets | $5,574,455 | $5,597,232 | | Total current liabilities | $2,513,010 | $2,207,197 | | Total liabilities | $2,514,043 | $2,217,293 | | Stockholders' equity | $3,060,412 | $3,379,939 | Legal and Contact Information This section outlines forward-looking statement disclaimers and provides essential company contact information Forward-Looking Statements This section serves as a cautionary statement regarding forward-looking information within the press release, highlighting inherent uncertainties and risks - Statements not purely historical are forward-looking, identified by words like "may," "will," "expect," "plan," "believe"[17] - Product candidates are in clinic and not approved; no assurance of clinical success, regulatory approval, or commercialization[17] - Forward-looking statements are subject to risks and uncertainties, including NASDAQ delisting, clinical trial delays, funding availability, and dilutive effects of stock issuances[17] - Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, except as required by law[17] Company Contact Provides contact information for Ensysce Biosciences, including the Chief Executive Officer and Investor Relations, for inquiries - Company Contact: Lynn Kirkpatrick, Ph.D., Chief Executive Officer, (858) 263-4196[18] - Investor Relations Contact: Shannon Devine, MZ North America, (203) 741-8811, ENSC@mzgroup.us[18]