UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: September 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-38306 ENSYSCE BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) | Delaware | 82-2755287 | | --- | --- | | (Stat ...

Financial Performance - Ensysce reported a net loss attributable to common stockholders of $3.7 million for Q3 2025, compared to a gain of $0.7 million in Q3 2024, reflecting a significant decline in profitability [13]. - Cash and cash equivalents decreased to $1.7 million as of September 30, 2025, down from $3.5 million at the end of 2024 [9]. - Total operating expenses for Q3 2025 were $4.2 million, compared to $2.8 million in Q3 2024, reflecting increased investment in R&D [20]. - Ensysce's total assets decreased to $3.2 million as of September 30, 2025, down from $5.6 million at the end of 2024 [24]. Research and Development - Research and development expenses increased to $3.0 million in Q3 2025, up from $1.7 million in the same period of 2024, driven by heightened clinical and pre-clinical activities [11]. - The initiation of the pivotal Phase 3 PF614-301 trial in July 2025 marks a major milestone in Ensysce's development of PF614, aimed at providing effective pain relief while minimizing abuse risk [5]. - The FDA granted Breakthrough Therapy designation for the PF614-MPAR program, which combines overdose protection with pain management capabilities [7]. - The company is advancing its opioid use disorder (OUD) program, with PF9001 selected as the lead candidate, supported by a multi-year HEAL grant [8]. Funding and Capital - Federal grants funding totaled $0.5 million in Q3 2025, a decrease of $2.9 million compared to $3.4 million in Q3 2024, primarily due to the timing of research activities [10]. - Ensysce completed a convertible preferred stock offering in November 2025, raising gross proceeds of $4 million, with an additional $16 million potentially available through future tranches [9].

~ Third Quarter Highlighted by Initiation of Phase 3 Study of PF614, Underscoring Progress Toward Market Readiness and Commitment to Novel Opioid Solutions ~ ~ Further Program Advancement Supported by Preferred Stock Financing ~ SAN DIEGO, CA / ACCESS Newswire / November 14, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering next-generation severe pain therapeutics designed to minimize abuse and overdose risk, today reported financ ...

[General Information](index=1&type=section&id=General%20Information) [Form 10-Q Filing Details](index=1&type=section&id=Form%2010-Q%20Filing%20Details) Ensysce Biosciences, Inc.'s Form 10-Q for Q2 2025 details its status as a Nasdaq-listed non-accelerated filer and smaller reporting company - The report is a Quarterly Report on Form 10-Q for the period ended June 30, 2025[2](index=2&type=chunk) - Ensysce Biosciences, Inc. is incorporated in Delaware and its common stock trades on The Nasdaq Stock Market under the symbol ENSC[3](index=3&type=chunk)[4](index=4&type=chunk) - The registrant is classified as a non-accelerated filer and a smaller reporting company[4](index=4&type=chunk) Common Stock Outstanding | As of Date | Shares Outstanding | | :--------- | :----------------- | | August 12, 2025 | 2,968,444 shares | [FORWARD-LOOKING STATEMENTS](index=3&type=section&id=FORWARD-LOOKING%20STATEMENTS) [Nature of Forward-Looking Statements](index=3&type=section&id=Nature%20of%20Forward-Looking%20Statements) Forward-looking statements, identifiable by specific terms, are based on current expectations but involve substantial risks and uncertainties, meaning actual results may differ materially - Forward-looking statements are identified by terms such as 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'might,' 'objective,' 'ongoing,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'will' and 'would,' or their negatives[6](index=6&type=chunk) - These statements are based on current expectations and projections about future events and financial trends, but involve substantial risks and uncertainties[6](index=6&type=chunk)[8](index=8&type=chunk) [Key Risks and Uncertainties](index=3&type=section&id=Key%20Risks%20and%20Uncertainties) Forward-looking statements are subject to risks including financing, product candidate failure, CRO reliance, IP, and regulatory approvals, which could materially affect actual results - Estimates regarding expenses, revenue, capital requirements, and timing/availability of additional financing may not match actual amounts[7](index=7&type=chunk)[9](index=9&type=chunk) - Ability to continue as a going concern for the next twelve months is uncertain[7](index=7&type=chunk)[9](index=9&type=chunk) - Risk that lead product candidates (PF614 and PF614-MPAR) may not successfully limit abuse, overdose, or misuse, or provide additional safety upon commercialization[7](index=7&type=chunk)[9](index=9&type=chunk) - Reliance on third-party contract research organizations (CROs) for R&D and clinical trials[7](index=7&type=chunk)[9](index=9&type=chunk) - Need for substantial additional funding to complete product candidate development and commercialization[7](index=7&type=chunk)[9](index=9&type=chunk) - Clinical trials may fail to replicate positive results from earlier studies[7](index=7&type=chunk)[9](index=9&type=chunk) - Product candidates may not progress through clinical development or receive required regulatory approvals within expected timelines or at all[7](index=7&type=chunk)[9](index=9&type=chunk) - Inability to successfully market or gain market acceptance of product candidates[7](index=7&type=chunk)[9](index=9&type=chunk) - Risk of overestimating target market size, patient willingness to try new therapies, and physician willingness to prescribe[7](index=7&type=chunk)[9](index=9&type=chunk) - Inability to obtain and maintain sufficient intellectual property protection or risk of infringing others' IP[7](index=7&type=chunk)[9](index=9&type=chunk) - Loss of key management team members[7](index=7&type=chunk)[9](index=9&type=chunk) - Changes in regulatory environment or industry[7](index=7&type=chunk)[9](index=9&type=chunk) - Ability to remediate material weaknesses or maintain effective internal controls over financial reporting[7](index=7&type=chunk)[9](index=9&type=chunk) - Risk of common stock delisting from Nasdaq or inability to maintain compliance with listing standards[7](index=7&type=chunk)[9](index=9&type=chunk) - The company will not update or revise any forward-looking statements unless required by applicable securities laws[8](index=8&type=chunk) [GLOSSARY](index=5&type=section&id=GLOSSARY) [Key Definitions](index=5&type=section&id=Key%20Definitions) This section defines key terms and acronyms used in the report, covering financial instruments, company entities, regulatory bodies, and proprietary technologies - The glossary defines various financial instruments and transactions, such as the 2021, 2022, and 2023 Notes, and different warrant inducements and offerings (e.g., 2024 February Warrant Inducement, 2025 April Warrant Inducement)[11](index=11&type=chunk) - Key company-specific terms include 'Company' (Ensysce Biosciences, Inc. and subsidiaries), 'EBIR' (79.2%-owned subsidiary developing overdose protection), 'TAAP' (Trypsin Activated Abuse Protection), and 'MPAR' (Multi-Pill Abuse Resistance)[11](index=11&type=chunk)[12](index=12&type=chunk) - Regulatory and market terms defined include FDA, GAAP, Nasdaq, NIDA, NIH, and SEC[12](index=12&type=chunk) [PART I. FINANCIAL INFORMATION](index=8&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=8&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents Ensysce Biosciences, Inc.'s unaudited consolidated financial statements, including balance sheets, statements of operations, equity changes, and cash flows, with explanatory notes [Consolidated Balance Sheets](index=8&type=section&id=Consolidated%20Balance%20Sheets) The consolidated balance sheets show a slight decrease in total assets and an increase in total liabilities from December 31, 2024, to June 30, 2025 Consolidated Balance Sheet Highlights | Item | June 30, 2025 (Unaudited) | December 31, 2024 | | :-------------------------------- | :-------------------------- | :------------------ | | Cash and cash equivalents | $2,211,575 | $3,502,077 | | Unbilled receivable | $1,204,979 | $124,115 | | 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 | | Total stockholders' equity | $3,060,412 | $3,379,939 | - Cash and cash equivalents decreased by approximately **$1.29 million** from December 31, 2024, to June 30, 2025[17](index=17&type=chunk) - Unbilled receivable increased significantly from **$124,115 to $1,204,979**[17](index=17&type=chunk) - Accrued expenses and other liabilities increased from **$548,458 to $1,045,657**[17](index=17&type=chunk) [Consolidated Statements of Operations](index=9&type=section&id=Consolidated%20Statements%20of%20Operations) The company reported a net loss for both periods, with increased federal grants offset by higher R&D expenses, and improved net loss per share due to more shares outstanding Consolidated Statements of Operations Highlights | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Federal grants | $1,371,438 | $181,797 | $2,691,210 | $487,519 | | Research and development expenses | $1,923,430 | $947,229 | $3,808,957 | $1,726,133 | | General and administrative expenses | $1,198,523 | $1,190,010 | $2,600,279 | $2,559,791 | | Net loss | $(1,733,517) | $(1,967,793) | $(3,679,090) | $(5,084,356) | | Net loss per basic and diluted share | $(0.79) | $(3.35) | $(2.04) | $(9.98) | | Weighted average common shares outstanding | 2,202,299 | 587,822 | 1,803,393 | 509,347 | - Federal grants revenue increased by **$1.19 million** (YoY) for the three months ended June 30, 2025, and by **$2.20 million** (YoY) for the six months ended June 30, 2025[20](index=20&type=chunk) - Research and development expenses increased by **$0.98 million** (YoY) for the three months ended June 30, 2025, and by **$2.08 million** (YoY) for the six months ended June 30, 2025[20](index=20&type=chunk) - Net loss per basic and diluted share improved from **$(3.35) to $(0.79)** for the three months ended June 30, 2025, and from **$(9.98) to $(2.04)** for the six months ended June 30, 2025, primarily due to a significant increase in weighted average common shares outstanding[20](index=20&type=chunk) [Consolidated Statements of Changes in Stockholders' Equity](index=10&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) The statements reflect a decrease in total stockholders' equity, with increases in common stock and additional paid-in capital from financing activities, offset by a growing accumulated deficit - Total stockholders' equity decreased from **$3,379,939** at December 31, 2024, to **$3,060,412** at June 30, 2025[17](index=17&type=chunk) - Additional paid-in capital increased from **$133,252,585 to $136,612,043**, driven by warrant exercises, warrant inducements, and a public offering[17](index=17&type=chunk)[23](index=23&type=chunk) - The accumulated deficit increased from **$(129,544,299) to $(133,223,223)** due to the net loss incurred during the period[17](index=17&type=chunk)[23](index=23&type=chunk) [Consolidated Statements of Cash Flows](index=12&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Operating cash flow remained negative but improved year-over-year, while financing activities provided less cash in 2025 compared to 2024 Consolidated Statements of Cash Flows Highlights (Six Months Ended June 30) | Item | 2025 | 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 | | Net decrease in cash and cash equivalents | $(1,290,502) | $(80,373) | | Cash and cash equivalents end of period | $2,211,575 | $1,043,231 | - Net cash used in operating activities decreased by **$1.3 million** (YoY) for the six months ended June 30, 2025, primarily due to greater grant funding and reduced cash outlays for accounts payable[25](index=25&type=chunk)[164](index=164&type=chunk) - Net cash provided by financing activities decreased by **$2.5 million** (YoY) for the six months ended June 30, 2025, mainly from warrant inducements and public offerings[25](index=25&type=chunk)[165](index=165&type=chunk) [Notes to Consolidated Financial Statements (Unaudited)](index=13&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements%20(Unaudited)) These notes explain the company's business, accounting policies, financial instruments, and significant transactions, including its clinical-stage status, going concern uncertainty, and equity financing [NOTE 1 – ORGANIZATION AND PRINCIPAL ACTIVITIES](index=13&type=section&id=NOTE%201%20%E2%80%93%20ORGANIZATION%20AND%20PRINCIPAL%20ACTIVITIES) Ensysce is a clinical-stage biotech developing safer prescription drugs using TAAP and MPAR technologies, with a subsidiary focused on overdose protection and COVID-19 treatment - Ensysce Biosciences, Inc. is a clinical-stage biotech company developing safer prescription drugs using proprietary TAAP (Trypsin Activated Abuse Protection) and MPAR (Multi-Pill Abuse Resistance) technology platforms[28](index=28&type=chunk) - The primary focus is on abuse and overdose resistant pain technology, with PF614 as a clinical-stage opioid product candidate and MPAR applied to the PF614 program and a methadone prodrug for Opioid Use Disorder[28](index=28&type=chunk) - EBIR, Inc., a **79.2%-owned** subsidiary, is developing a compound for overdose protection and COVID-19 treatment, with noncontrolling interests held by key personnel and an unrelated party[28](index=28&type=chunk)[29](index=29&type=chunk) [NOTE 2 - BASIS OF PRESENTATION](index=13&type=section&id=NOTE%202%20-%20BASIS%20OF%20PRESENTATION) The financial statements are GAAP and SEC compliant, reflect a December 2024 reverse stock split, and highlight going concern uncertainty due to lack of product revenue and need for financing - Consolidated financial statements are prepared in accordance with U.S. GAAP and SEC rules, including Ensysce Biosciences, Inc. and its subsidiaries[30](index=30&type=chunk) - A **1-for-15** reverse stock split was completed in December 2024, with all share and per share amounts retrospectively restated[31](index=31&type=chunk) - The company has not generated product revenue and requires significant additional financing, raising substantial doubt about its ability to continue as a going concern for the next 12 months[33](index=33&type=chunk)[34](index=34&type=chunk) [NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=14&type=section&id=NOTE%203%20-%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines the company's accounting policies, including single segment reporting, Level 3 fair value measurements for liability classified warrants, federal grant revenue recognition, and expensing of R&D and G&A costs - The company operates and manages its business as one reportable and operating segment[39](index=39&type=chunk) - Liability classified warrants are measured at fair value using a Black-Scholes model and classified as Level 3 inputs[44](index=44&type=chunk)[46](index=46&type=chunk) Fair Value of Liability Classified Warrants (Level 3) | Date | Fair Value | | :-------------------- | :----------- | | June 30, 2025 | $1,033 | | December 31, 2024 | $10,096 | - Revenue from federal grants (MPAR and OUD) is recognized as costs are incurred and assessed as reimbursable[50](index=50&type=chunk) Federal Grant Revenue | Grant Type | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | MPAR | $1,371,438 | $- | $2,691,210 | $- | | TAAP/OUD | $- | $181,797 | $- | $487,519 | | Total | $1,371,438 | $181,797 | $2,691,210 | $487,519 | - Research and development expenses and general and administrative expenses are charged to expense as incurred[52](index=52&type=chunk)[53](index=53&type=chunk) - The company maintains a full valuation allowance against all deferred tax assets due to uncertainty of realization[146](index=146&type=chunk) [NOTE 4 – PREPAID EXPENSES AND OTHER CURRENT ASSETS](index=18&type=section&id=NOTE%204%20%E2%80%93%20PREPAID%20EXPENSES%20AND%20OTHER%20CURRENT%20ASSETS) Prepaid expenses and other current assets increased slightly from December 31, 2024, to June 30, 2025, primarily due to higher prepaid insurance and other current assets Prepaid Expenses and Other Current Assets | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Prepaid research and development | $1,060,659 | $1,342,461 | | Prepaid insurance | $403,087 | $315,306 | | Other prepaid expenses | $160,265 | $42,723 | | Other current assets | $241,030 | $18,000 | | Total | $1,865,041 | $1,718,490 | - Total prepaid expenses and other current assets increased by **$146,551** from December 31, 2024, to June 30, 2025[64](index=64&type=chunk) [NOTE 5 – OTHER ASSETS](index=18&type=section&id=NOTE%205%20%E2%80%93%20OTHER%20ASSETS) Other assets increased significantly, primarily due to a substantial rise in deposits, partially offset by a decrease in long-term prepaid insurance Other Assets | Item | June 30, 2025 | December 31, 2024 | | :---------------- | :------------ | :---------------- | | Prepaid insurance | $166,667 | $250,000 | | Deposits | $126,193 | $2,550 | | Total | $292,860 | $252,550 | - Total other assets increased by **$40,310** from December 31, 2024, to June 30, 2025[65](index=65&type=chunk) - Deposits increased from **$2,550 to $126,193**[65](index=65&type=chunk) [NOTE 6 – ACCRUED EXPENSES AND OTHER LIABILITIES](index=18&type=section&id=NOTE%206%20%E2%80%93%20ACCURUED%20EXPENSES%20AND%20OTHER%20LIABILITIES) Accrued expenses and other liabilities nearly doubled from December 31, 2024, to June 30, 2025, driven by increased accrued R&D costs and new consultant compensation accruals Accrued Expenses and Other Liabilities | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Accrued research and development | $640,603 | $324,521 | | Accrued consultant compensation | $180,000 | $- | | Accrued professional fees | $57,562 | $88,995 | | Other accrued liabilities | $167,492 | $134,942 | | Total | $1,045,657 | $548,458 | - Total accrued expenses and other liabilities increased by **$497,199** from December 31, 2024, to June 30, 2025[66](index=66&type=chunk) - Accrued research and development increased by **$316,082**, and **$180,000** was accrued for consultant compensation[66](index=66&type=chunk) [NOTE 7 - COMMITMENTS AND CONTINGENCIES](index=18&type=section&id=NOTE%207%20-%20COMMITMENTS%20AND%20CONTINGENCIES) The company has $8.3 million in R&D purchase commitments, settled a consultant dispute with common shares and accruals, and has a product development agreement involving milestone-based stock issuance - As of June 30, 2025, the company had estimated purchase commitments of **$8.3 million** related to open purchase orders and contractual obligations, primarily with contract research organizations for multi-year pre-clinical and clinical research studies[67](index=67&type=chunk) - In April 2025, the company settled a dispute with a former independent contractor by issuing **20,000 shares** of common stock and accruing a total settlement value of **$0.2 million**[69](index=69&type=chunk) - A product development and supply agreement with Galephar Pharmaceutical Research, Inc. involves issuing **13,801 restricted shares** of common stock upon specific operational and regulatory milestones, with one-third vesting immediately[70](index=70&type=chunk)[71](index=71&type=chunk) - The Galephar agreement also includes milestone-based payments to be settled in common stock, for which the company recognized **$140,000** in R&D expense for the six months ended June 30, 2025[72](index=72&type=chunk) [NOTE 8 - NOTES PAYABLE](index=19&type=section&id=NOTE%208%20-%20NOTES%20PAYABLE) Notes payable primarily consist of 2023 Notes and financed insurance premiums, with significantly reduced interest expense in 2025 as debt discount amortization concluded Outstanding Debt Summary | Item | June 30, 2025 (Net Debt) | December 31, 2024 (Net Debt) | | :------------------ | :----------------------- | :--------------------------- | | 2023 Notes | $236,475 | $230,368 | | Financed insurance | $188,046 | $71,292 | | Total | $424,521 | $301,660 | Interest Expense | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Financed insurance | $0 | $148 | $909 | $2,092 | | 2023 Notes | $3,160 | $27,563 | $6,107 | $1,300,000 | - The original debt discount and issuance costs for the 2023 Notes were fully amortized to interest expense by December 31, 2024[77](index=77&type=chunk)[78](index=78&type=chunk) - The remaining 2023 Notes are senior secured convertible promissory notes held by a company board member, subject to a forbearance agreement expiring April 25, 2026[79](index=79&type=chunk)[104](index=104&type=chunk) [NOTE 9 - STOCKHOLDERS' EQUITY](index=20&type=section&id=NOTE%209%20-%20STOCKHOLDERS'%20EQUITY) This note details the company's equity structure and recent financing activities, including several warrant inducements and registered direct offerings that increased common stock and additional paid-in capital - The company's Certificate of Incorporation authorizes **250,000,000 shares** of common stock and **1,500,000 shares** of preferred stock, with no preferred stock outstanding[81](index=81&type=chunk) - In April 2025, the company completed a warrant inducement, generating approximately **$2.2 million** in gross proceeds by incentivizing the exercise of **630,376 existing warrants** and issuing **1,260,752 new unregistered Common Warrants**[82](index=82&type=chunk)[83](index=83&type=chunk)[120](index=120&type=chunk) - In March 2025, a registered direct offering and concurrent private placement generated approximately **$1.1 million** in gross proceeds from the sale of common stock and pre-funded warrants, and issued **630,376 new unregistered Series A-5 and Series A-6 warrants**[85](index=85&type=chunk)[86](index=86&type=chunk)[122](index=122&type=chunk)[123](index=123&type=chunk) - In August 2024, a registered direct offering and warrant inducement generated approximately **$1.7 million** from common stock/pre-funded warrants and **$3.4 million** from warrant exercises, and issued **1,863,706 new unregistered warrants**[87](index=87&type=chunk)[125](index=125&type=chunk)[126](index=126&type=chunk)[127](index=127&type=chunk) - In February 2024, a warrant inducement generated approximately **$4.7 million** in gross proceeds by incentivizing the exercise of **240,120 existing warrants** and issuing **480,240 new unregistered Series A and Series B Warrants**[90](index=90&type=chunk)[129](index=129&type=chunk) Summary of Outstanding Warrants (June 30, 2025) | Reference | Shares Underlying Outstanding Warrants | Exercise Price | Classification | | :-------- | :----------------------------------- | :------------- | :------------- | | April 2025 Warrants | 1,282,320 | $1.90 - $4.05 | Equity | | March 2025 Warrants | 22,063 | $4.3625 | Equity | | August 2024 Warrants | 1,864,545 | $7.05 - $8.8125 | Equity | | February 2024 Warrants | 16,811 | $24.56 | Equity | | 2023 Notes Warrants | 162,881 | $7.05 - $23.51 | Equity | | Other Warrants | 73,474 | $54.56 - $41,400 | Equity & Liability | | Total | 3,422,094 | | | [NOTE 10 - STOCK-BASED COMPENSATION](index=25&type=section&id=NOTE%2010%20-%20STOCK-BASED%20COMPENSATION) Stock-based compensation expense increased in 2025, with 64,000 stock options granted to employees and board members at a weighted-average fair value of $2.63 Stock-Based Compensation Expense | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | General and administrative | $62,137 | $18,658 | $73,133 | $42,146 | | Research and development | $150,222 | $7,891 | $201,569 | $17,610 | - During the six months ended June 30, 2025, the company granted **64,000 stock options** to employees and board members, with exercise prices ranging from **$2.00 to $3.12** per share[99](index=99&type=chunk) - The weighted-average grant date fair value of options granted during the six months ended June 30, 2025, was **$2.63**[102](index=102&type=chunk) - As of June 30, 2025, there was **$89,539** of unrecognized share-based compensation cost, expected to be recognized over a weighted average period of **0.79 years**[102](index=102&type=chunk) Shares Reserved for Future Issuance (June 30, 2025) | Item | Shares | | :------------------------------------------ | :------- | | Awards outstanding under the Plan | 102,785 | | Awards available for future grant under the Plan | 14,385 | | Warrants outstanding | 3,422,094 | | Shares for consultant compensation agreement outside the Plan | 13,801 | | Total shares of common stock reserved for future issuance | 3,553,065 | [NOTE 11 - RELATED PARTIES](index=26&type=section&id=NOTE%2011%20-%20RELATED%20PARTIES) As of June 30, 2025, the company had a $0.2 million senior secured convertible promissory note plus accrued interest and 29,547 warrants outstanding to a board member, subject to a forbearance agreement expiring April 25, 2026 - As of June 30, 2025, the company held a **$0.2 million** senior secured convertible promissory note plus accrued interest and **29,547 warrants** (exercisable at **$23.51** per share) issued to a board member[104](index=104&type=chunk) - A forbearance agreement with the board member regarding these notes will expire on April 25, 2026[104](index=104&type=chunk) [NOTE 12 - SUBSEQUENT EVENTS](index=26&type=section&id=NOTE%2012%20-%20SUBSEQUENT%20EVENTS) Subsequent to June 30, 2025, the company issued 575,188 shares of common stock for $1.1 million in cash proceeds from the exercise of certain April 2025 warrants - Since June 30, 2025, the company issued **575,188 shares** of common stock for cash proceeds of **$1.1 million** upon exercise of certain April 2025 warrants[105](index=105&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, highlighting its clinical-stage status, operating losses, and dependence on future financing [Overview](index=27&type=section&id=Overview) Ensysce is a clinical-stage pharmaceutical company developing abuse and overdose resistant pain relief solutions, facing significant operating losses and requiring substantial additional funding to continue as a going concern - Ensysce is a clinical-stage pharmaceutical company focused on developing innovative solutions for severe pain relief, reducing opioid misuse, abuse, and overdose[108](index=108&type=chunk) - Lead product candidate PF614 (extended release TAAP prodrug of oxycodone) is in Phase 3 clinical development, PF614-MPAR is in Phase 1b, and nafamostat has completed Phase 1[108](index=108&type=chunk)[110](index=110&type=chunk) - The company has incurred significant operating losses since inception, has no products approved for sale, and has not generated revenue from product sales[109](index=109&type=chunk)[111](index=111&type=chunk) - Substantial additional funding is required to support continuing operations and growth strategy, with current cash sufficient only into the third quarter of 2025, raising substantial doubt about the company's ability to continue as a going concern[113](index=113&type=chunk)[116](index=116&type=chunk) [2025 April Warrant Inducement](index=28&type=section&id=2025%20April%20Warrant%20Inducement) In April 2025, the company generated $2.2 million in gross proceeds by incentivizing warrant exercises and issuing new unregistered Common Warrants, incurring $0.3 million in costs and issuing placement agent warrants - In April 2025, the company entered into an Inducement Letter for the exercise of **630,376 outstanding warrants**[118](index=118&type=chunk) - Gross proceeds from the exercise of warrants and payment for new Common Warrants totaled approximately **$2.2 million**[120](index=120&type=chunk) - The company issued **1,260,752 new unregistered Common Warrants** with an exercise price of **$1.90** per share, expiring in 18 months and 5 years[120](index=120&type=chunk) - Transaction costs included approximately **$0.3 million** in legal fees and other closing costs, and the issuance of **44,126 unregistered placement agent warrants**[121](index=121&type=chunk) [2025 Registered Direct Offering and 2025 March Warrant Offering](index=29&type=section&id=2025%20Registered%20Direct%20Offering%20and%202025%20March%20Warrant%20Offering) In March 2025, the company raised $1.1 million in gross proceeds from a registered direct offering and private placement, issuing new unregistered warrants and paying placement agent fees - In March 2025, the company issued **239,594 shares** of common stock and pre-funded warrants for **75,594 shares**, generating approximately **$1.1 million** in gross proceeds[122](index=122&type=chunk) - Concurrently, **630,376 unregistered Series A-5 and Series A-6 warrants** were issued, with an exercise price of **$3.24** per share[123](index=123&type=chunk) - The company paid a cash fee of **$77,000** and **$65,950** for expenses to the placement agent, and issued **22,063 placement agent warrants**[124](index=124&type=chunk) [2024 Registered Direct Offering and 2024 August Warrant Inducement](index=29&type=section&id=2024%20Registered%20Direct%20Offering%20and%202024%20August%20Warrant%20Inducement) In August 2024, the company raised $1.7 million from a direct offering and $3.4 million from warrant exercises, issuing new unregistered warrants and paying placement agent fees - In August 2024, the company issued **166,054 shares** of common stock and pre-funded warrants for **70,827 shares**, generating approximately **$1.7 million** in gross proceeds[125](index=125&type=chunk) - An inducement agreement led to the exercise of **480,234 outstanding warrants** at a reduced exercise price of **$7.05** per share, generating approximately **$3.4 million** in gross proceeds[126](index=126&type=chunk) - The company issued **1,863,706 new unregistered warrants** with an exercise price of **$7.05** per share[127](index=127&type=chunk) - Placement agent fees included a **$354,000** cash fee, **$100,950** for expenses, and the issuance of **50,200 placement agent warrants**[128](index=128&type=chunk) [2024 February Warrant Inducement](index=30&type=section&id=2024%20February%20Warrant%20Inducement) In February 2024, the company generated $4.7 million in gross proceeds by incentivizing warrant exercises and issuing new unregistered warrants, also repaying $0.5 million in notes with a premium - In February 2024, the company induced the exercise of **240,120 existing warrants** at a reduced exercise price of **$19.65** per share, generating approximately **$4.7 million** in gross proceeds[129](index=129&type=chunk) - New unregistered Series A and Series B Warrants were issued to purchase up to **480,240 shares** of Common Stock, both with an exercise price of **$15.90** per share[129](index=129&type=chunk) - A waiver related to the 2023 Notes' SPA required repayment of **$0.5 million** of investor-held notes with a **$0.5 million** premium[130](index=130&type=chunk) - Transaction costs included approximately **$0.3 million** in legal fees and other closing costs, and the issuance of **16,811 unregistered placement agent warrants**[131](index=131&type=chunk) [Components of Our Operating Results](index=30&type=section&id=Components%20of%20Our%20Operating%20Results) This section details the company's revenue, primarily from federal grants, and operating expenses, particularly R&D, which are significant and expected to increase [Revenue](index=30&type=section&id=Revenue) The company generates limited revenue primarily from federal grants, with no product sales expected in the near future, and grant funds recognized as costs are incurred - The company has generated limited revenue since inception and does not expect product sales revenue in the near future[132](index=132&type=chunk) - Revenue is primarily derived from federal grants, specifically MPAR and OUD grants from the NIH through NIDA[133](index=133&type=chunk) - Grant revenue is recognized when costs related to the grants are incurred and assessed as reimbursable[133](index=133&type=chunk) [Operating Expenses](index=31&type=section&id=Operating%20Expenses) Operating expenses, comprising R&D and G&A costs, are expensed as incurred and are expected to increase as product candidates advance and public company operations expand [Research and Development Expenses](index=31&type=section&id=Research%20and%20Development%20Expenses) R&D expenses, including third-party costs for studies and manufacturing, are expensed as incurred and are expected to remain elevated as product candidates advance through clinical development, contingent on financing - Research and development expenses consist primarily of third-party costs (CROs, CMOs, consultants), preclinical and clinical studies, and employee-related expenses[134](index=134&type=chunk)[137](index=137&type=chunk) - R&D costs are expensed as incurred and are not tracked on a program-by-program basis[134](index=134&type=chunk)[135](index=135&type=chunk) - R&D expenses are expected to remain elevated as the company continues existing and initiates new clinical trials for PF614, PF614-MPAR, and nafamostat, and conducts other preclinical and clinical development, contingent on obtaining financing[136](index=136&type=chunk) [General and Administrative Expenses](index=32&type=section&id=General%20and%20Administrative%20Expenses) G&A expenses, including personnel and professional fees, are expensed as incurred and are anticipated to increase with headcount and public company operational requirements, particularly for pre-commercialization activities - General and administrative expenses primarily consist of employee-related expenses (salaries, benefits, stock-based compensation) for executive, finance, HR, and administrative functions[140](index=140&type=chunk) - These expenses also include professional fees for legal, patent, consulting, investor relations, accounting, and audit services[140](index=140&type=chunk) - G&A expenses are anticipated to increase in the future due to increased headcount, significant accounting, audit, legal, regulatory, compliance, and investor relations costs, and preparation for commercial operations[141](index=141&type=chunk) [Other Income (Expense)](index=33&type=section&id=Other%20Income%20(Expense)) Other income (expense) includes changes in fair value of liability classified warrants, interest expense, and provision for income taxes, with a full valuation allowance maintained against deferred tax assets [Change in fair value of liability classified warrants](index=33&type=section&id=Change%20in%20fair%20value%20of%20liability%20classified%20warrants) Changes in the fair value of liability classified warrants are recognized through earnings each reporting period, estimated using a Black-Scholes option pricing model - Changes in the fair value of liability classified warrants are recognized through earnings for each reporting period[143](index=143&type=chunk) - The fair value of these warrants is estimated using a Black-Scholes option pricing model[143](index=143&type=chunk) [Interest Expense](index=33&type=section&id=Interest%20Expense) Interest expense includes interest accrued on financed directors' and officers' insurance and interest from the 2023 Notes, which also reflected amortization of debt discount and issuance costs - Interest expense consists of interest accrued on financed directors' and officers' insurance and interest from the 2023 Notes[144](index=144&type=chunk) - The 2023 Notes interest expense included amortization of the debt discount from original issuance and warrant issuances, and associated debt issuance costs[144](index=144&type=chunk) [Provision for Income Taxes](index=33&type=section&id=Provision%20for%20Income%20Taxes) The company accounts for income taxes using the asset and liability method but has not recorded significant income tax expense due to net losses, maintaining a full valuation allowance against deferred tax assets - The company accounts for income taxes using the asset and liability method[146](index=146&type=chunk) - No significant income tax expense or benefits have been recorded, and a full valuation allowance is maintained against all deferred tax assets[145](index=145&type=chunk)[146](index=146&type=chunk) - The company is evaluating the impact of ASU No. 2023-09, 'Income Taxes (Topic 740): Improvements to Income Tax Disclosures,' effective for annual periods beginning after December 15, 2024[61](index=61&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) This section compares the company's financial performance for the three and six months ended June 30, 2025, versus 2024, highlighting increased federal grant revenue and R&D expenses, leading to a reduced net loss [Comparison of the Three Months Ended June 30, 2025 and 2024](index=34&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) For Q2 2025, federal grants revenue increased by $1.2 million, R&D expenses rose by $1.0 million, G&A remained stable, and net loss decreased by $234,276 Results of Operations (Three Months Ended June 30) | Item | 2025 | 2024 | Change | | :------------------------------------------ | :----------- | :----------- | :----------- | | Federal grants | $1,371,438 | $181,797 | $1,189,641 | | Research and development | $1,923,430 | $947,229 | $976,201 | | General and administrative | $1,198,523 | $1,190,010 | $8,513 | | Loss from operations | $(1,750,515) | $(1,955,442) | $204,927 | | Net loss | $(1,733,517) | $(1,967,793) | $234,276 | - Federal grants revenue increased by **$1.2 million**, primarily due to increased activities under the MPAR grant in 2025[150](index=150&type=chunk) - Research and development expenses increased by **$1.0 million**, driven by higher clinical and pre-clinical activity for PF614-MPAR[151](index=151&type=chunk) - General and administrative expenses remained consistent at **$1.2 million**[152](index=152&type=chunk) [Comparison of the six months ended June 30, 2025 and 2024](index=35&type=section&id=Comparison%20of%20the%20six%20months%20ended%20June%2030%2C%202025%20and%202024) For the six months ended June 30, 2025, federal grant funding increased by $2.2 million, R&D expenses rose by $2.1 million, G&A remained stable, and net loss decreased by $1.4 million Results of Operations (Six Months Ended June 30) | Item | 2025 | 2024 | Change | | :------------------------------------------ | :----------- | :----------- | :----------- | | Federal grants | $2,691,210 | $487,519 | $2,203,691 | | Research and development | $3,808,957 | $1,726,133 | $2,082,824 | | General and administrative | $2,600,279 | $2,559,791 | $40,488 | | Loss from operations | $(3,718,026) | $(3,798,405) | $80,379 | | Net loss | $(3,679,090) | $(5,084,356) | $1,405,266 | - Federal grant funding increased by **$2.2 million**, attributed to a new MPAR grant that began in September 2024[155](index=155&type=chunk) - Research and development expenses increased by **$2.1 million**, driven by increased clinical and pre-clinical programs for PF614 and PF614-MPAR[155](index=155&type=chunk) - General and administrative expenses remained stable at **$2.6 million** for both periods[156](index=156&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) The company had $2.2 million in cash as of June 30, 2025, faces significant operating losses, and requires additional capital to continue as a going concern, with $9.4 million in MPAR grant funding remaining - As of June 30, 2025, the company had **$2.2 million** in cash and cash equivalents[159](index=159&type=chunk) - The company has incurred significant operating losses and negative cash flows, and current cash is sufficient only into the fourth quarter of 2025, raising substantial doubt about its ability to continue as a going concern[159](index=159&type=chunk)[162](index=162&type=chunk) - Future operations will require additional capital, expected to be funded through public or private equity offerings, debt financings, or collaboration agreements[160](index=160&type=chunk) - Remaining funding under the MPAR federal research grant totaled **$9.4 million** at June 30, 2025, expected to be utilized by May 31, 2027[161](index=161&type=chunk) Cash Flows (Six Months Ended June 30) | Item | 2025 | 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 | | Net decrease in cash and cash equivalents | $(1,290,502) | $(80,373) | - Net cash used in operating activities decreased by **$1.3 million** (YoY) in 2025, while net cash provided by financing activities decreased by **$2.5 million** (YoY)[164](index=164&type=chunk)[165](index=165&type=chunk) - Commitments as of June 30, 2025, included an estimated **$8.3 million** related to open purchase orders and contractual obligations, primarily for multi-year pre-clinical and clinical research studies[168](index=168&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=38&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) Financial statement preparation requires significant estimates and judgments, particularly for accrued R&D expenses, based on service progress from third parties, with potential for adjustments - Preparation of consolidated financial statements requires significant estimates and judgments, especially for accrued research and development expenses[171](index=171&type=chunk)[173](index=173&type=chunk) - Estimates for R&D expenses are based on reviewing open contracts, communicating with personnel, and assessing the progress of services from CROs and other third parties[173](index=173&type=chunk) - Variations in the actual timing or level of effort for services compared to estimates could lead to adjustments in accruals or prepaid expenses[173](index=173&type=chunk) [Off-Balance Sheet Arrangements](index=39&type=section&id=Off-Balance%20Sheet%20Arrangements) The company reported no off-balance sheet arrangements during the periods presented or currently - The company does not have any off-balance sheet arrangements[176](index=176&type=chunk) [Recently Issued Accounting Pronouncements](index=39&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) The company is evaluating the impact of recently issued accounting pronouncements, including ASU No. 2023-09, ASU 2024-03, and ASU 2024-04, on its consolidated financial statements - The company is evaluating the impact of ASU No. 2023-09, 'Income Taxes (Topic 740): Improvements to Income Tax Disclosures,' effective for annual periods beginning after December 15, 2024[61](index=61&type=chunk) - The company is evaluating the impact of ASU 2024-03, 'Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures,' effective for annual periods beginning after December 15, 2026[62](index=62&type=chunk) - The company is evaluating the impact of ASU 2024-04, 'Debt – Debt with Conversion and other Options,' effective for all entities after December 15, 2025[63](index=63&type=chunk) [Smaller Reporting Company Status](index=39&type=section&id=Smaller%20Reporting%20Company%20Status) The company qualifies as a 'smaller reporting company,' allowing reduced disclosure obligations, a status that will change if its public float or annual revenues exceed specified thresholds - The company is a 'smaller reporting company,' which allows for reduced disclosure obligations, including providing only two years of audited financial statements[178](index=178&type=chunk) - This status will be maintained until the market value of common stock held by non-affiliates exceeds **$250 million** or annual revenues exceed **$100 million** and market value exceeds **$700 million**[178](index=178&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to market risks primarily related to interest rates and inflation, though neither is expected to have a material impact on its financial position or operations [Interest Rate Risk](index=39&type=section&id=Interest%20Rate%20Risk) The company's cash and cash equivalents are held in cash and a short-term money market fund, so interest rate changes are not expected to materially impact its financial position or results of operations - Cash and cash equivalents consist of cash and a money market fund account[180](index=180&type=chunk) - Due to the short-term nature of the money market fund, changes in market interest rates are not expected to have a material impact on financial position or results of operations[180](index=180&type=chunk) [Inflation Risk](index=39&type=section&id=Inflation%20Risk) The company does not believe that inflation and changing prices have had a significant impact on its results of operations for any periods presented - The company does not believe that inflation and changing prices had a significant impact on its results of operations for any periods presented[181](index=181&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[182](index=182&type=chunk) - No changes in internal control over financial reporting occurred during the fiscal quarter that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[183](index=183&type=chunk) [PART II. OTHER INFORMATION](index=40&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company may face various disputes, but as of June 30, 2025, no pending legal proceedings are expected to materially adversely affect its financial condition or operations - The company may become involved in disputes and litigation related to intellectual property, licensing, contract law, and employee relations[184](index=184&type=chunk) - As of June 30, 2025, and December 31, 2024, there were no pending legal proceedings against the company expected to have a material adverse effect on cash flows, financial condition, or results of operations[68](index=68&type=chunk)[184](index=184&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) This section refers to the detailed discussion of risk factors in the company's 2024 Annual Report on Form 10-K, which could materially affect its financial condition and results of operations - A detailed discussion of risk factors is included in Part I, Item 1A. Risk Factors of the company's 2024 Annual Report on Form 10-K[185](index=185&type=chunk) - These risks and uncertainties have the potential to materially affect the company's financial condition and results of operations[185](index=185&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=40&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Information on unregistered equity sales in April 2025 was previously disclosed, and 20,000 common shares were issued to a former contractor to resolve a dispute, exempt from registration - Information concerning the sale of unregistered securities in April 2025 was disclosed in a Current Report on Form 8-K filed on April 24, 2025[186](index=186&type=chunk) - On April 7, 2025, the company issued **20,000 shares** of common stock to a former independent contractor as compensation to resolve a dispute, exempt from registration under Section 4(a)(2) of the Securities Act[187](index=187&type=chunk) [Item 3. Defaults Upon Senior Securities](index=40&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company - This item is not applicable[188](index=188&type=chunk) [Item 4. Mine Safety Disclosures](index=40&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable[189](index=189&type=chunk) [Item 5. Other Information](index=40&type=section&id=Item%205.%20Other%20Information) No other information is reported under this item - No other information is reported under this item[190](index=190&type=chunk) [Item 6. Exhibits](index=40&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the report, including certifications from the Principal Executive Officer and Principal Financial Officer, and Inline XBRL documents - Exhibits include certifications from the Principal Executive Officer and Principal Financial Officer pursuant to the Sarbanes-Oxley Act of 2002[191](index=191&type=chunk) - Inline XBRL documents (Instance, Schema, Calculation, Definition, Label, Presentation Linkbase Documents) and the Cover Page Interactive Data File are also filed[191](index=191&type=chunk) [Signatures](index=42&type=section&id=Signatures) The report is duly signed on behalf of Ensysce Biosciences, Inc. by David Humphrey, Chief Financial Officer, Secretary, and Treasurer, on August 13, 2025 - The report is signed by David Humphrey, Chief Financial Officer, Secretary and Treasurer of Ensysce Biosciences, Inc.[195](index=195&type=chunk) - The signing date is August 13, 2025[195](index=195&type=chunk)

[Executive Summary & Q2 2025 Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Q2%202025%20Highlights) 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](index=1&type=section&id=Q2%202025%20Highlights%20and%20Strategic%20Outlook) 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](index=1&type=chunk)[2](index=2&type=chunk) - Completed **full enrollment** for Part 2 of the PF614-MPAR-102 study, advancing the overdose-protection product[1](index=1&type=chunk)[2](index=2&type=chunk) - Received a **$5.3 million** installment from NIDA, supporting the overdose protection program[1](index=1&type=chunk)[8](index=8&type=chunk) - CEO emphasizes momentum in developing opioid therapeutics with built-in safety features against misuse and overdose, aiming to reshape the opioid treatment landscape[2](index=2&type=chunk) [Program Updates](index=1&type=section&id=Program%20Updates) Ensysce updates on TAAP, MPAR, and OUD programs, highlighting clinical progress, regulatory designations, and IP [TAAP (Opioid Abuse Deterrent Program) Update](index=1&type=section&id=TAAP%20(Opioid%20Abuse%20Deterrent%20Program)%20Update) 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](index=3&type=chunk) - 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](index=4&type=chunk) - Engaged **Rho, Inc.**, a clinical research organization, to conduct the PF614-301 trial, marking a major step toward redefining pain therapy[4](index=4&type=chunk) [MPAR® (Opioid Abuse Deterrent and Overdose Protection Program) Update](index=2&type=section&id=MPAR%C2%AE%20(Opioid%20Abuse%20Deterrent%20and%20Overdose%20Protection%20Program)%20Update) 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](index=5&type=chunk) - Received **FDA Breakthrough Therapy designation** in January 2024 for PF614-MPAR due to its potential to prevent overdose while maintaining pain relief[5](index=5&type=chunk)[6](index=6&type=chunk) - 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](index=6&type=chunk) - The program is supported by a multi-year **NIDA grant**[6](index=6&type=chunk) [OUD Program Update](index=2&type=section&id=OUD%20Program%20Update) 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](index=7&type=chunk) - Selected **PF9001** as its lead OUD candidate in 2024, evaluating it for oral delivery, reduced cardiovascular risk, and built-in overdose protection[7](index=7&type=chunk) - The OUD program is supported by a multi-year **HEAL (Helping to End Addiction Long-Term) grant from NIDA**[7](index=7&type=chunk) - 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](index=7&type=chunk) [Q2 2025 Financial Results Overview](index=2&type=section&id=Q2%202025%20Financial%20Results%20Overview) Ensysce's Q2 2025 financials show decreased cash, increased federal grants and R&D, and a reduced net loss [Cash and Federal Grants](index=2&type=section&id=Cash%20and%20Federal%20Grants) 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 **$15 million**, three-year grant from NIDA, available for R&D expenses under the MPAR program through May 2026[8](index=8&type=chunk) Federal Grants Funding (Three Months Ended June 30) | Period | 2025 ($ 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](index=9&type=chunk) [Operating Expenses](index=2&type=section&id=Operating%20Expenses) 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 | $0.9 | - The increase in R&D expenses was primarily due to external research and development costs related to PF614-MPAR, with increased pre-clinical and clinical activity[10](index=10&type=chunk) General & Administrative Expenses (Three Months Ended June 30) | Period | 2025 ($ million) | 2024 ($ million) | | :----- | :--------------- | :--------------- | | G&A expenses | $1.2 | $1.2 | [Net Income (Loss)](index=2&type=section&id=Net%20Income%20(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](index=12&type=chunk) [Company Information](index=3&type=section&id=Company%20Information) This section overviews Ensysce Biosciences, its mission, and definitions of its core TAAP and MPAR technologies [About Ensysce Biosciences](index=3&type=section&id=About%20Ensysce%20Biosciences) 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](index=14&type=chunk) - Utilizes **Trypsin-Activated Abuse Protection (TAAP)** and **Multi-Pill Abuse Resistance (MPAR)** platforms to develop unique, tamper-proof treatment options[14](index=14&type=chunk) - Mission is to provide safer options for patients with severe pain and prevent deaths caused by medication abuse[14](index=14&type=chunk) [Definitions](index=3&type=section&id=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](index=15&type=chunk) - **MPAR (Multi-Pill Abuse Resistance)** is designed to protect against abuse and accidental overdose[16](index=16&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) This section presents Ensysce Biosciences' condensed consolidated statements of operations, cash flows, and balance sheets [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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) | $(9.98) | [Condensed Consolidated Statements of Cash Flows](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) The Condensed Consolidated Statements of Cash Flows detail the cash movements for the six months ended June 30, 2025, and 2024, showing a decrease in cash and cash equivalents Condensed Consolidated Statements of Cash Flows (Six Months Ended June 30) | Item | H1 2025 ($) | 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 | $1,043,231 | [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The Condensed Consolidated Balance Sheets present Ensysce Biosciences' financial position as of June 30, 2025, compared to December 31, 2024, showing a slight decrease in total assets and stockholders' equity Condensed Consolidated Balance Sheets | Item | June 30, 2025 ($) | 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](index=3&type=section&id=Legal%20and%20Contact%20Information) This section outlines forward-looking statement disclaimers and provides essential company contact information [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) 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](index=17&type=chunk) - Product candidates are in clinic and not approved; no assurance of clinical success, regulatory approval, or commercialization[17](index=17&type=chunk) - Forward-looking statements are subject to **risks and uncertainties**, including NASDAQ delisting, clinical trial delays, funding availability, and dilutive effects of stock issuances[17](index=17&type=chunk) - Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, except as required by law[17](index=17&type=chunk) [Company Contact](index=3&type=section&id=Company%20Contact) 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](index=18&type=chunk) - Investor Relations Contact: Shannon Devine, MZ North America, **(203) 741-8811**, ENSC@mzgroup.us[18](index=18&type=chunk)

[PART I. FINANCIAL INFORMATION](index=8&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=8&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited consolidated financial statements for the quarter ended March 31, 2025, reflecting a **net loss of $1.95 million** and a **cash position of $3.1 million**, with management noting substantial doubt about the company's ability to continue as a going concern [Consolidated Balance Sheets](index=8&type=section&id=Consolidated%20Balance%20Sheets) Total assets decreased to **$4.6 million** as of March 31, 2025, from **$5.6 million** at year-end 2024, primarily due to reduced cash and cash equivalents, leading to a decline in total stockholders' equity Consolidated Balance Sheet Highlights (Unaudited) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | 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** | | Total current liabilities | $1,761,176 | $2,207,197 | | **Total liabilities** | **$1,891,356** | **$2,217,293** | | **Total stockholders' equity** | **$2,720,518** | **$3,379,939** | [Consolidated Statements of Operations](index=9&type=section&id=Consolidated%20Statements%20of%20Operations) The company reported a **net loss of $1.95 million** for Q1 2025, a significant improvement from **$3.12 million** in Q1 2024, primarily driven by reduced interest expense despite increased R&D costs Quarterly Operating Results (Unaudited) | Metric | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 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) | | Interest expense, net | $(3,856) | $(1,248,065) | | **Net loss** | **$(1,945,573)** | **$(3,116,563)** | | **Net loss per share, basic and diluted** | **$(1.39)** | **$(8.21)** | [Consolidated Statements of Cash Flows](index=11&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly decreased to **$1.7 million** in Q1 2025 from **$3.4 million** in Q1 2024, while financing activities provided **$1.3 million**, resulting in a **$0.45 million** decrease in cash and cash equivalents Quarterly Cash Flow Summary (Unaudited) | Cash Flow Activity | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,707,412) | $(3,408,403) | | Net cash provided by financing activities | $1,257,826 | $5,689,148 | | **Net increase (decrease) in cash** | **$(449,586)** | **$2,280,745** | | **Cash and cash equivalents, end of period** | **$3,052,491** | **$3,404,349** | [Notes to Consolidated Financial Statements (Unaudited)](index=12&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements%20(Unaudited)) Key disclosures include the company's clinical-stage biotech status, a **1-for-15** reverse stock split, substantial doubt about its going concern ability, and details on federal grants, debt, and recent equity financing activities, including a **$2.2 million** raise in April 2025 - The company is a clinical-stage biotech developing abuse-resistant (TAAP) and overdose-resistant (MPAR®) pain technologies[28](index=28&type=chunk) - Management has concluded there is **substantial doubt** about the Company's ability to continue as a going concern for the next 12 months, as it is dependent on obtaining additional financing[33](index=33&type=chunk)[34](index=34&type=chunk) - A **1-for-15** reverse stock split of common stock was completed in December 2024, and all share and per-share amounts have been retrospectively restated[31](index=31&type=chunk) - In March 2025, the company raised approximately **$1.1 million** in gross proceeds through a registered direct offering and concurrent private placement of warrants[83](index=83&type=chunk)[84](index=84&type=chunk) - As of March 31, 2025, the company had purchase commitments of an estimated **$7.9 million** related to open purchase orders and contractual obligations with CROs[68](index=68&type=chunk) - Subsequent to the quarter end, in April 2025, the company raised gross proceeds of **$2.2 million** through the exercise of warrants and issuance of new warrants[102](index=102&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial results, liquidity, and operational outlook, highlighting its clinical-stage nature, dependence on external funding, and the **going concern** issue, with current cash funding operations only into Q3 2025 - The company is a clinical-stage entity focused on developing safer pain relief drugs (PF614, PF614-MPAR) and has not yet generated any product revenue[105](index=105&type=chunk)[106](index=106&type=chunk) - Management has **substantial doubt** about the company's ability to continue as a going concern, with current cash expected to fund operations only into the **third quarter of 2025**[113](index=113&type=chunk)[151](index=151&type=chunk) Key Changes in Operating Results (Q1 2025 vs Q1 2024) | Item | Change | Reason | | :--- | :--- | :--- | | Federal Grants | +$1.0M | Increased activities under the new MPAR grant | | R&D Expenses | +$1.1M | Increased pre-clinical activity for PF614-MPAR | | Interest Expense | -$1.2M | Full amortization of 2023 Notes' discount and issuance costs in 2024 | - The company has actively raised capital through multiple offerings and warrant inducements in 2024 and 2025 to fund operations, including a **$1.1 million** offering in March 2025[116](index=116&type=chunk)[119](index=119&type=chunk)[123](index=123&type=chunk) - As of March 31, 2025, the company had commitments of approximately **$8.1 million**, primarily for multi-year pre-clinical and clinical research studies with CROs[157](index=157&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company identifies interest rate and inflation as primary market risks, but management believes these are not material due to the short-term nature of cash equivalents and minimal impact of inflation on operations - The company's exposure to interest rate risk is considered **minimal** due to the short-term nature of its cash and cash equivalents[169](index=169&type=chunk) - Management does not believe that inflation has **not had a significant impact** on the company's results of operations[170](index=170&type=chunk) [Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were **effective** as of March 31, 2025, with no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were **effective** as of March 31, 2025[171](index=171&type=chunk) - **No changes** occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[172](index=172&type=chunk) [PART II. OTHER INFORMATION](index=37&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no pending legal proceedings expected to have a material adverse effect on its financial condition or operations, noting a **$0.2 million** settlement with a former contractor in April 2025 - As of the reporting date, there were **no pending legal proceedings** expected to have a material adverse effect on the company[69](index=69&type=chunk)[173](index=173&type=chunk) - In April 2025, a dispute with a former contractor was settled for a total value of **$0.2 million**, which includes the issuance of 20,000 shares of stock[70](index=70&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) This section refers investors to the detailed discussion of risk factors in the company's 2024 Annual Report on Form 10-K - For a detailed discussion of risk factors, the company refers to its 2024 Annual Report on Form 10-K[174](index=174&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company entered a product development and supply agreement with Galephar Pharmaceutical Research, Inc. in January 2025, where Galephar will fund up to **$10 million** for R&D and manufacturing in exchange for unregistered common stock, exempt from Securities Act registration - In January 2025, the company entered into a Master Services Agreement with Galephar Pharmaceutical Research, Inc. to support the development and manufacturing of its PF614 and PF614-MPAR products[175](index=175&type=chunk) - Galephar will expend up to **$10 million**, and in return, Ensysce will issue unregistered common stock, including an initial grant of **13,801 restricted shares** and further milestone-based payments[175](index=175&type=chunk) - The issuance of these securities was **exempt from registration** under Section 4(a)(2) of the Securities Act[175](index=175&type=chunk) [Defaults Upon Senior Securities](index=38&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable - Not applicable[176](index=176&type=chunk) [Mine Safety Disclosures](index=38&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable - Not applicable[177](index=177&type=chunk) [Other Information](index=38&type=section&id=Item%205.%20Other%20Information) There is no other information to disclose for this item - None[178](index=178&type=chunk)

[Operational Highlights & Strategic Outlook](index=1&type=section&id=Operational%20Highlights%20%26%20Strategic%20Outlook) [CEO Commentary & Strategic Outlook](index=1&type=section&id=CEO%20Commentary%20%26%20Strategic%20Outlook) 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](index=2&type=chunk) - 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](index=2&type=chunk) - 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](index=2&type=chunk) [Clinical Program Updates](index=1&type=section&id=Clinical%20Program%20Updates) 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](index=1&type=section&id=TAAP%E2%84%A2%20(Opioid%20Abuse%20Deterrent%20Program)%20Update) 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](index=3&type=chunk) - The company plans to initiate the Phase 3 PF614-301 clinical study in mid-2025, following receipt of FDA feedback in December 2024[4](index=4&type=chunk) [MPAR® (Opioid Abuse Deterrent and Overdose Protection Program) Update](index=1&type=section&id=MPAR%C2%AE%20(Opioid%20Abuse%20Deterrent%20and%20Overdose%20Protection%20Program)%20Update) 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](index=5&type=chunk) - The program received FDA's Breakthrough Therapy designation in January 2024 based on initial clinical trial data[5](index=5&type=chunk) - 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](index=6&type=chunk) [Opioid Use Disorder (OUD) Program Update](index=2&type=section&id=Opioid%20Use%20Disorder%20(OUD)%20Program%20Update) 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](index=7&type=chunk) - Secured a U.S. patent titled "Enzyme-Cleavable Methadone Prodrugs and Methods of Use Thereof," which covers the composition and use of PF9001[8](index=8&type=chunk) - 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](index=7&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) [Q1 2025 Financial Results Summary](index=2&type=section&id=Q1%202025%20Financial%20Results%20Summary) 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](index=9&type=chunk) - 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](index=11&type=chunk) [Condensed Consolidated Financial Statements](index=4&type=section&id=Condensed%20Consolidated%20Financial%20Statements) 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](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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** |

Core Insights - Ensysce Biosciences, Inc. (ENSC) stock experienced a nearly 100% increase in value, with significant trading volume surpassing the average of 81.23K shares [1] - The company received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent related to Enzyme-Cleavable Methadone Prodrugs, which includes claims for both composition and methods of use [1] Group 1: Product Development and Clinical Trials - PF9001, the medication associated with the new patent, aims to provide a safer treatment for opioid use disorder (OUD) utilizing Ensysce's TAAP and MPAR technologies for abuse deterrence and overdose protection [2] - Methadone has been traditionally used for OUD, but its application has been limited due to concerns about cardiac side effects and overdose risks [3] - Ensysce has developed PF9001, which shows reduced cardiotoxicity and validates the MPAR technology for overdose protection, with indications of a prolonged effect from once-daily dosing [3] Group 2: Clinical Trial Results - The National Institute on Drug Abuse supported the research for the patent, and Ensysce completed Part 1 of its second clinical trial for PF614-MPAR, which demonstrated effective overdose protection while relieving severe pain [4] - The trial confirmed that a 100 mg dosage of PF614-MPAR provides overdose protection when doses exceed the prescribed amount, showing reduced maximum oxycodone release compared to PF614 alone [5] - Safety data from the trial indicated no unexpected adverse events, and the study will continue to evaluate food effects and repeat dosing [6] Group 3: Financial Activities - Ensysce Biosciences announced a registered direct offering of approximately $1.1 million in March, issuing 315,188 shares at a price of $3.49 per share [7] - Following the news, ENSC stock rose by 96.30%, reaching a price of $3.67 [7]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-38306 ENSYSCE BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) | Delaware | 82-2755287 | | --- | --- | | (State or othe ...

[Operational and Strategic Highlights](index=1&type=section&id=Operational%20and%20Strategic%20Highlights) 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](index=1&type=section&id=TAAP%E2%84%A2%20(Opioid%20Abuse%20Deterrent%20Program)%20Update) 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](index=4&type=chunk) - A strategic partnership was formed with a specialty drug manufacturer to prepare for the commercial supply and launch of PF614[5](index=5&type=chunk) [MPAR™ (Opioid Abuse Deterrent and Overdose Protection Program) Update](index=1&type=section&id=MPAR%E2%84%A2%20(Opioid%20Abuse%20Deterrent%20and%20Overdose%20Protection%20Program)%20Update) 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](index=6&type=chunk) - The MPAR™ technology received FDA Breakthrough Therapy designation in January 2024 following positive data from the initial PF614-MPAR-101 trial[6](index=6&type=chunk) - 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](index=7&type=chunk) [Opioid Use Disorder (OUD) Program Update](index=2&type=section&id=Opioid%20Use%20Disorder%20(OUD)%20Program%20Update) 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](index=8&type=chunk) - The OUD program aims to create a safer methadone alternative by reducing abuse potential and cardiovascular side effects, making treatment more accessible[8](index=8&type=chunk) - The program is supported by a multi-year Helping to End Addiction Long-Term (HEAL) award and is advancing through non-clinical studies[8](index=8&type=chunk) - Secured a strategic partnership with a leading specialty drug manufacturer for the future commercial production of PF614 and PF614-MPAR[3](index=3&type=chunk)[5](index=5&type=chunk) - 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](index=3&type=chunk) - 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](index=3&type=chunk)[7](index=7&type=chunk) [Q4 & Full Year 2024 Financial Results](index=2&type=section&id=Q4%20%26%20Full%20Year%202024%20Financial%20Results) 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](index=9&type=chunk) - 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](index=10&type=chunk) [Consolidated Financial Statements](index=4&type=section&id=Consolidated%20Financial%20Statements) 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](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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)** |