Ensysce Biosciences, Inc.

Previous wording

We have generated limited revenues and have incurred significant operating losses since our inception and expect to continue to incur operating losses for the foreseeable future. These factors raise substantial doubt about our ability to continue as a going concern. Our future viability is dependent on our ability to raise additional capital to finance our operations. Without raising additional capital through a future offering, we believe that current cash on hand is sufficient to fund operations into the third quarter of 2025. We based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “—Liquidity and Capital Resources.” Our future viability beyond the twelve months is dependent on our ability to raise additional capital to finance our operations.

Current wording

We have generated limited revenues and have incurred significant operating losses since our inception and expect to continue to incur operating losses for the foreseeable future. These factors raise substantial doubt about our ability to continue as a going concern. Our future viability is dependent on our ability to raise additional capital to finance our operations. Without raising additional capital through a future offering, we believe that current cash on hand is sufficient to fund operations into the late fourth quarter of 2025. We based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See “—Liquidity and Capital Resources.” Our future viability beyond the twelve months is dependent on our ability to raise additional capital to finance our operations.

Previous wording

Revenue from federal grants totaled $1.4 million for the three months ended June 30, 2025, compared to $0.2 million for the three months ended June 30, 2024, respectively. The $1.2 million difference is due to the timing of research activities eligible for funding, with increased activities in 2025 under the MPAR grant which began in September 2024. The 2024 period included limited funding under the OUD grant with research activity constrained until the selection of a lead product candidate in June 2024.

Current wording

Revenue from federal grants totaled $0.5 million for the three months ended September 30, 2025, compared to $3.4 million for the three months ended September 30, 2024, respectively. This $2.9 million decrease is primarily due to the timing of research activities eligible for funding under the MPAR grant which began in September 2024. The 2024 period included significant funding under the OUD grant with research activity following the selection of a lead product candidate in June 2024.

Previous wording

Research and development expenses were $1.9 million for the three months ended June 30, 2025, compared to $0.9 million for the three months ended June 30, 2024, representing an increase of $1.0 million. The increase was primarily the result of external research and development costs related to increased clinical and pre-clinical activity for PF614-MPAR in the 2025 period. We expect future research and development expenses to increase once we begin the Phase 3 clinical trial for PF614, with such timing dependent upon our ability to raise capital sufficient to fund these expenses.

Current wording

Research and development expenses were $3.0 million for the three months ended September 30, 2025, compared to $1.7 million for the three months ended September 30, 2024, representing an increase of $1.3 million. The increase was primarily the result of external research and development costs related to increased clinical and pre-clinical activity for PF614 and PF614-MPAR in the 2025 period. We expect future research and development expenses to increase once we begin the Phase 3 clinical trial for PF614, with such timing dependent upon our ability to raise capital sufficient to fund these expenses.

Previous wording

General and administrative expenses were $1.2 million for the three months ended June 30, 2025, and the three months ended June 30, 2024. We expect future general and administrative expenses to approximate current levels.

Current wording

General and administrative expenses were $1.3 million for the three months ended September 30, 2025 and $1.1 million the three months ended September 30, 2024. We expect future general and administrative expenses to approximate current levels.

Previous wording

Funding from federal grants for the six months ended June 30, 2025 and 2024 totaled $2.7 million and $0.5 million, respectively. The increase of approximately $2.2 million is due to the timing of research activities eligible for funding, as funding under the initial MPAR grant was completed in December 2023 and funding under a subsequent MPAR grant began in September 2024.

Current wording

Funding from federal grants for the nine months ended September 30, 2025 and 2024 totaled $3.2 million and $3.9 million, respectively. The decrease of approximately $0.7 million is due to the timing of research activities eligible for funding under the OUD and MPAR grants. A decrease of $2.1 million in funding under the OUD grant that ended in August 2024 was offset by an increase of $1.4 million in funding under the MPAR grant which began in September 2024.

Previous wording

Research and development expenses for the six months ended June 30, 2025, and 2024 were $3.8 million and $1.7 million, respectively, representing a increase of $2.1 million. The increase was primarily the result of external research and development costs related to increased clinical and pre-clinical programs for PF614 and PF614-MPAR. We expect future research and development expenses to increase once we begin the Phase 3 clinical trial for PF614, with such timing dependent upon our ability to raise capital sufficient to fund these expenses.

Current wording

Research and development expenses for the nine months ended September 30, 2025, and 2024 were $6.8 million and $3.4 million, respectively, representing an increase of $3.3 million. The increase was primarily the result of external research and development costs related to increased clinical and pre-clinical programs for PF614 and PF614-MPAR. We expect future research and development expenses to increase once we begin the Phase 3 clinical trial for PF614, with such timing dependent upon our ability to raise capital sufficient to fund these expenses.

Previous wording

General and administrative expenses for the six months ended June 30, 2025, and 2024 were $2.6 million for each period. We expect future general and administrative expenses to approximate current levels.

Current wording

General and administrative expenses for the nine months ended September 30, 2025, and 2024 were $3.9 million and $3.6 million, respectively. We expect future general and administrative expenses to approximate current levels.

Previous wording

Other income and expense for the six months ended June 30, 2025, consisted primarily of interest income from cash and cash equivalents. Other income and expense for the six months ended June 30, 2024, consisted primarily of interest expense associated with the amortization of the original issue discount and the debt issuance costs associated with the 2023 Notes.

Current wording

Other income and expense for the nine months ended September 30, 2025, consisted primarily of interest income from cash and cash equivalents. Other income and expense for the nine months ended September 30, 2024, consisted primarily of interest expense associated with the amortization of the original issue discount and the debt issuance costs associated with the 2023 Notes.

Previous wording

As of June 30, 2025, we had $2.2 million of cash and cash equivalents. Since inception, we have generated limited revenues and have incurred significant operating losses and negative cash flows from our operations, and we anticipate that we will continue to incur losses for at least the foreseeable future. We have not yet commercialized any of our product candidates and we do not expect to generate revenue from sales of any product candidates for several years, if at all.

Current wording

As of September 30, 2025, we had $1.7 million of cash and cash equivalents. In November 2025, we completed a convertible preferred stock offering with gross proceeds of $4 million. Since inception, we have generated limited revenues and have incurred significant operating losses and negative cash flows from our operations, and we anticipate that we will continue to incur losses for at least the foreseeable future. We have not yet commercialized any of our product candidates and we do not expect to generate revenue from sales of any product candidates for several years, if at all.

Previous wording

The remaining funding under the MPAR federal research grant totaled $9.4 million at June 30, 2025, and is expected to be utilized by May 31, 2027. Pursuant to the terms and conditions, we are required to submit progress reports to NIDA on an annual basis and a final research performance progress report within 120 days of the performance period end date.

Current wording

The remaining funding under the MPAR federal research grant totaled $8.7 million at September 30, 2025, and is expected to be utilized by May 31, 2027. Pursuant to the terms and conditions, we are required to submit progress reports to NIDA on an annual basis and a final research performance progress report within 120 days of the performance period end date.

Previous wording

We have generated limited revenues and have incurred significant operating losses since our inception. We expect to continue to incur significant expenses and operating losses for the foreseeable future. Without capital raised through financing transactions, existing cash resources are sufficient to allow us to fund current planned operations into the fourth quarter of 2025, which raises substantial doubt about our ability to continue as a going concern.

Current wording

We have generated limited revenues and have incurred significant operating losses since our inception. We expect to continue to incur significant expenses and operating losses for the foreseeable future. Without capital raised through financing transactions, existing cash resources are sufficient to allow us to fund current planned operations into the late first quarter of 2026, which raises substantial doubt about our ability to continue as a going concern.

Previous wording

Cash Flows for the six months ended June 30, 2025, and 2024

Current wording

Cash Flows for the nine months ended September 30, 2025, and 2024

Previous wording

During the six months ended June 30, 2025 and 2024, we used cash in operating activities of $4.4 million and $5.7 million, respectively. The decrease primarily resulted from greater cash inflows from grant funding in 2025 and a reduction in cash outlays for accounts payable in 2025.

Current wording

During the nine months ended September 30, 2025 and 2024, we used cash in operating activities of $6.3 million and $6.7 million, respectively. The decrease primarily resulted from greater cash inflows from grant funding in 2025.

Previous wording

During the six months ended June 30, 2025, net cash provided by financing activities was $3.1 million, primarily consisting of net proceeds from warrant inducements, a public offering of common stock and warrant exercises. During the six months ended June 30, 2024, net cash provided by financing activities was $5.6 million, primarily consisting of net proceeds from a warrant inducement and warrant exercises, less repayment of convertible notes.

Current wording

During the nine months ended September 30, 2025, net cash provided by financing activities was $4.6 million, primarily consisting of net proceeds from warrant inducements, a public offering of common stock and warrant exercises. During the nine months ended September 30, 2024, net cash provided by financing activities was $9.8 million, primarily consisting of net proceeds from a public offering of common stock, warrant inducement and warrant exercises, and less repayment of convertible notes.

Previous wording

Our commitments as of June 30, 2025, included an estimated $8.3 million related to open purchase orders and contractual obligations that occurred in the ordinary course of business, including commitments with contract research organizations for multi-year pre-clinical and clinical research studies. Although open purchase orders are considered enforceable and legally binding, the terms generally allow us the option to cancel, reschedule, and adjust requirements based on our business needs prior to the delivery of goods or the performance of services.

Current wording

Our commitments as of September 30, 2025, included an estimated $7.3 million related to open purchase orders and contractual obligations that occurred in the ordinary course of business, including commitments with contract research organizations for multi-year pre-clinical and clinical research studies. Although open purchase orders are considered enforceable and legally binding, the terms generally allow us the option to cancel, reschedule, and adjust requirements based on our business needs prior to the delivery of goods or the performance of services.