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: June 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. UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Exact name of registrant as specified in its charter) | Delaware | 82-2755287 | | --- | --- | | (State or ...

Exhibit 99.1 Ensysce Biosciences Reports Second Quarter 2025 Financial Results and Latest Program Updates Initiates Critical Milestone, Launching Phase 3 Trial of PF614 to Advance Next-Generation Opioid Therapy Toward Regulatory Approval Receives $5.3 Million Installment from NIDA To Support Overdose Protection Program The Company's lead product, PF614, is a Trypsin-Activated Abuse Protection (TAAP) extended-release oxycodone and a potential "next generation" analgesic to treat severe pain. PF614's TAAP che ...

[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** |

Ensysce Biosciences, Inc ENSC stock gained almost 100% with a strong session volume compared to the average volume of 81.23K, as per data from Benzinga Pro.Ensysce Biosciences on Wednesday received a Notice of Allowance from the U.S. Patent and Trademark Office for the issuance of a patent entitled Enzyme-Cleavable Methadone Prodrugs and Methods of Use Thereof including both composition of matter and method of use claims.PF9001, the medication covered by this patent, is designed to provide a safer treatment ...

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)** |

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

Financial Performance - Ensysce has incurred significant operating losses since its inception and expects to continue incurring net losses for the foreseeable future[97]. - The company has not generated any revenue from product sales and may never be able to commercialize a marketable product[95]. - Net income for Q3 2024 was $661,769, a significant improvement from a net loss of $2.7 million in Q3 2023, reflecting a change of $3.35 million[134]. - The company does not expect to generate revenue from product candidates for several years, if at all[146]. - The company has incurred significant operating losses since inception and expects to continue doing so for the foreseeable future, raising substantial doubt about its ability to continue as a going concern[149]. Funding and Cash Flow - Ensysce requires substantial additional funding to support ongoing operations and growth strategy, expecting to finance through equity offerings, debt financings, or collaborations[99]. - The company generated gross proceeds of approximately $4.7 million from the exercise of warrants at a reduced exercise price of $1.31 per share[104]. - In August 2024, Ensysce agreed to issue 2,490,798 shares of common stock at an offering price of $0.47 per share, generating gross proceeds of approximately $1.67 million[108]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $9.8 million, compared to $7.3 million in the same period of 2023, mainly from a public offering and warrant exercises[151]. - The remaining cash funding under the MPAR federal research grant totaled $14 million as of September 30, 2024, expected to be utilized by May 31, 2027[148]. - Cash used in operating activities for the nine months ended September 30, 2024, was $6.7 million, a decrease from $9.0 million in the same period of 2023, primarily due to timing of vendor invoicing and reduced R&D activities[150]. - The net increase in cash and cash equivalents for the nine months ended September 30, 2024, was $3.0 million, compared to a decrease of $1.7 million in the same period of 2023[152]. - As of September 30, 2024, the company had $4.2 million in cash and cash equivalents, with expectations of continued operating losses for the foreseeable future[146]. Research and Development - The lead product candidate, PF614, is ready for Phase 3 clinical development, while PF614-MPAR is in Phase 1b and nafamostat has completed Phase 1 clinical development[96]. - Research and development expenses are expected to remain elevated due to ongoing and planned clinical trials for PF614, PF614-MPAR, and nafamostat[119]. - Research and development expenses for Q3 2024 were $1.7 million, down from $1.9 million in Q3 2023, representing a decrease of $0.2 million[136]. - Research and development expenses for the nine months ended September 30, 2024, were $3.4 million, down from $5.4 million in 2023, representing a decrease of $2 million[142]. - The company has not yet completed any pivotal clinical trials or obtained regulatory approvals for its product candidates[96]. - The company anticipates a substantial increase in expenses related to ongoing preclinical activities and clinical trials, as well as costs associated with operating as a public company[155]. Grants and Collaborations - The company has received federal grants from the NIH for the development of its MPAR® overdose prevention technology[113]. - Federal grant funding for Q3 2024 was $3.4 million, a significant increase from $0.4 million in Q3 2023, reflecting a change of $2.98 million[135]. - Federal grant funding for the nine months ended September 30, 2024, totaled $3.9 million, compared to $1.7 million for the same period in 2023, an increase of $2.19 million[141]. - The company may have to relinquish valuable rights to technologies or future revenue streams if it raises additional funds through collaborations[100]. Operating Expenses - General and administrative expenses for Q3 2024 were $1.1 million, a decrease of $0.1 million compared to $1.2 million in Q3 2023[137]. - Total operating expenses for Q3 2024 were $2.8 million, down from $3.1 million in Q3 2023, indicating a reduction of $0.37 million[134]. - General and administrative expenses for the nine months ended September 30, 2024, were $3.6 million, a decrease of $0.3 million from $3.9 million in 2023[143]. - As of September 30, 2024, the company had approximately $13.3 million in commitments related to open purchase orders and contractual obligations for research studies[156]. - The company expects future funding requirements to depend significantly on the progress and costs of research and development, regulatory reviews, and commercialization efforts[157].

Financial Performance - Net income attributable to common stockholders for Q3 2024 was $0.7 million, compared to a net loss of $2.7 million in Q3 2023, attributed to the timing of federal grant funding[12]. - The company expects net income for Q3 2024 to be a one-time event, with anticipated losses in future quarters due to ongoing R&D efforts[12]. - Total operating expenses for Q3 2024 were $2.8 million, down from $3.1 million in Q3 2023[10]. Grants and Funding - Ensysce received a $14 million multi-year NIH grant to support the clinical development of PF614-MPAR, allowing the initiation of a second Phase 1b trial[2]. - Federal grants totaled $3.4 million for Q3 2024, a significant increase from $0.4 million in the same quarter of 2023, due to increased research activities[9]. - Ensysce anticipates advancing its opioid use disorder program with the lead candidate PF9001, supported by a $15 million NIH grant[7]. Cash and Assets - Cash and cash equivalents increased to $4.2 million as of September 30, 2024, compared to $1.1 million as of December 31, 2023, driven by cumulative net proceeds of $8.5 million from equity financings[8]. - Total current assets increased to $9,090,507 in 2024 from $2,288,868 in 2023, representing a growth of approximately 297%[18]. - Cash and cash equivalents rose significantly to $4,153,592 in 2024, up from $1,123,604 in 2023, marking an increase of about 270%[18]. - Total assets increased to $9,384,724 in 2024 from $2,708,085 in 2023, showing a growth of around 247%[18]. Liabilities and Equity - Total liabilities decreased to $2,804,997 in 2024 from $3,359,352 in 2023, reflecting a reduction of approximately 16.5%[18]. - Current liabilities decreased to $2,801,784 in 2024 from $3,332,964 in 2023, a decline of approximately 15.9%[18]. - Long-term liabilities decreased significantly to $3,213 in 2024 from $26,388 in 2023, a reduction of about 87.8%[18]. - Stockholders' equity improved to $6,579,727 in 2024, compared to a deficit of $(651,267) in 2023, indicating a positive turnaround[18]. Research and Development - Research and development expenses were $1.7 million for Q3 2024, a decrease from $1.9 million in Q3 2023, primarily due to reduced external costs related to clinical programs[10]. - The company submitted the Phase 3 protocol for PF614 to the FDA, expecting feedback by the end of November 2024[2]. - The lead product PF614 is designed with Trypsin-Activated Abuse Protection (TAAP) technology, aimed at reducing opioid abuse and overdose risks[3]. Other Financial Metrics - Accounts payable slightly increased to $1,967,573 in 2024 from $1,936,007 in 2023, a rise of about 1.6%[18]. - Prepaid expenses and other current assets surged to $4,936,915 in 2024, up from $1,165,264 in 2023, an increase of approximately 323%[18]. - Accrued expenses and other liabilities decreased to $447,035 in 2024 from $542,260 in 2023, a decline of approximately 17.5%[18].