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Ensysce Biosciences, Inc.

For the period ended Jun 30, 2026. Filed Aug 13, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2026 · Filed Aug 13, 2026

ENSC$0.33-8.9%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-03-31; filed 2026-05-15.

0001493152-26-023811

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-06-30; filed 2026-08-13.

0001493152-26-037817

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 94 previous paragraphs and 106 current paragraphs.

78 unchanged; 16 reworded; 10 added; 0 removed; 0 previous and 2 current paragraphs rearranged.

Tables are not compared: 9 previous and 12 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (10)

Current report

On August 5, 2026, we completed the acquisition of Cy Biopharma, Inc., a clinical-stage biotechnology company focused on the development of therapies for chronic pain. Its lead product candidate, for the treatment of Complex Regional Pain Syndrome (CRPS) Type 1, has received Orphan Drug Designation from the U.S. Food and Drug Administration. The acquisition consideration consisted primarily of shares of our Series C Preferred Stock issued to the former equity holders of Cy Biopharma. Concurrent with the acquisition, we entered into a private placement financing for gross proceeds of approximately $21.5 million, with the potential for an additional financing tranche of up to approximately $38.6 million upon the achievement of specified clinical development milestones.

Current report

Funding from federal grants for the six months ended June 30, 2026 and 2025 totaled $2.1 million and $2.7 million, respectively. The decrease of approximately $0.6 million is primarily due to the timing of research activities eligible for funding under the MPAR grant.

Current report

General and administrative expenses for the six months ended June 30, 2026, and 2025 were $2.4 million and $2.6 million, respectively, representing a decrease of $0.2 million.
Reworded paragraphs (16)

Previous wording

We require substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of private and public equity offerings, debt financings or other capital sources, which may include collaborations with other companies or other strategic transactions. To the extent that we raise additional capital through the sale of private or public equity or convertible debt securities, existing ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our equity holders.

Current wording

We require substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of private and public equity offerings, debt financings or other capital sources, which may include collaborations with other companies or other strategic transactions, including a product development and manufacturing collaboration that we entered into previously. To the extent that we raise additional capital through the sale of private or public equity or convertible debt securities, existing ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our equity holders.

Previous wording

Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, issuing additional equity, making acquisitions or capital expenditures or declaring dividends. If we raise additional funds through collaborations or other strategic transactions with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or drug candidates, or grant licenses on terms that may not be favorable to us. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates or delay our pursuit of potential in-licenses or acquisitions.

Current wording

Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, issuing additional equity, making acquisitions or capital expenditures or declaring dividends. If we raise additional funds through collaborations or other strategic transactions with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or drug candidates, or grant licenses on terms that may not be favorable to us and our stockholders may suffer significant dilution in any such transaction. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates or delay our pursuit of potential in-licenses or acquisitions.

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 through late second quarter of 2026. 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 through late third quarter of 2026. 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

On April 6, 2026, the Company closed a private placement with an institutional investor pursuant to a Securities Purchase Agreement originally entered into on November 13, 2025. The Company issued 2,000 shares of Series B Preferred Stock convertible into up to 4,363,636 shares of common stock at a conversion price of $0.55 per share, for gross proceeds of $2.0 million before fees and expenses. In connection with the closing, the Company also issued (i) warrants to purchase up to 4,363,637 shares of common stock exercisable for 18 months and (ii) warrants to purchase up to 4,363,636 shares of common stock exercisable for five years, in each case at an exercise price of $0.55 per share and exercisable immediately upon issuance. Additionally, warrants to purchase up to 261,818 shares of common stock were issued to the Company’s financial advisor. All warrants are subject to customary anti-dilution adjustments. In connection with closing, the Company amended its Certificate of Designation to increase the stated value per share of all outstanding Series B Preferred Stock from $1,100 to $1,200 per share.

Current wording

On April 6, 2026, we closed a private placement with the same institutional investor pursuant to the Securities Purchase Agreement originally entered into on November 13, 2025. The Company issued 2,000 shares of Series B Preferred Stock convertible into up to 4,363,636 shares of common stock at a conversion price of $0.55 per share, for gross proceeds of $2.0 million before fees and expenses. In connection with the closing, the Company also issued (i) warrants to purchase up to 4,363,637 shares of common stock exercisable for 18 months and (ii) warrants to purchase up to 4,363,636 shares of common stock exercisable for five years, in each case at an exercise price of $0.55 per share and exercisable immediately upon issuance. Additionally, warrants to purchase up to 261,818 shares of common stock were issued to the Company’s financial advisor. All warrants are subject to anti-dilution adjustments. In connection with the closing, the Company amended its Certificate of Designation to increase the stated value per share of all outstanding Series B Preferred Stock from $1,100 to $1,200 per share.

Previous wording

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect that our research and development expenses will remain elevated as we continue our existing, and commence additional, planned clinical trials for PF614, PF614-MPAR® and nafamostat, as well as conduct other preclinical and clinical development, including submitting regulatory filings for our other product candidates, subject to our ability to obtain financing. We also expect our related personnel costs to increase and, as a result, we expect our research and development expenses, including costs associated with stock-based compensation, to remain elevated. In addition, we may incur additional expenses related to milestone and royalty payments payable to third parties with whom we may enter into license, acquisition and option agreements to acquire the rights to future product candidates.

Current wording

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect that our research and development expenses will remain elevated as we continue our existing, and commence additional, planned clinical trials for PF614 and PF614-MPAR®, as well as conduct other preclinical and clinical development, including submitting regulatory filings for our other product candidates, subject to our ability to obtain financing. We also expect our related personnel costs to increase and, as a result, we expect our research and development expenses, including costs associated with stock-based compensation, to remain elevated. In addition, we may incur additional expenses related to milestone and royalty payments payable to third parties with whom we may enter into license, acquisition and option agreements to acquire the rights to future product candidates.

Previous wording

Revenue from federal grants totaled $1.0 million for the three months ended March 31, 2026, compared to $1.3 million for the three months ended March 31, 2025, respectively. This $0.3 million decrease is primarily due to the timing of research activities eligible for funding under the MPAR grant.

Current wording

Revenue from federal grants totaled $1.2 million for the three months ended June 30, 2026, compared to $1.4 million for the three months ended June 30, 2025, respectively. This $0.2 million decrease is primarily due to the timing of research activities eligible for funding under the MPAR grant.

Previous wording

Research and development expenses were $3.3 million for the three months ended March 31, 2026, compared to $1.9 million for the three months ended March 31, 2025, representing an increase of $1.5 million. The increase was primarily the result of external research and development costs related to increased clinical activity for PF614. We expect future research and development expenses to fluctuate with activity under 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 $2.5 million for the three months ended June 30, 2026, compared to $1.9 million for the three months ended June 30, 2025, representing an increase of $0.5 million. The increase was primarily the result of external research and development costs related to increased clinical activity for PF614. We expect future research and development expenses to fluctuate with activity under 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 March 31, 2026 and $1.4 million the three months ended March 31, 2025, representing a decrease of $0.2 million. 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 June 30, 2026 and $1.2 million the three months ended June 30, 2025, representing an increase of $0.1 million. We expect future general and administrative expenses to approximate current levels.

Previous wording

Other income and expense for the three months ended March 31, 2026, consisted primarily of interest income from cash and cash equivalents. For the comparative period for 2025, other income and expense included changes in the fair value of the warrant liabilities recognized through earnings.

Current wording

Other income and expense for the six months ended June 30, 2026 and 2025, consisted primarily of interest income from cash and cash equivalents.

Previous wording

As of March 31, 2026, we had $0.7 million of cash and cash equivalents. In April 2026, the Company issued 2,000 shares of Series B Preferred, for gross proceeds of $2.0 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 candidate for several years, if at all.

Current wording

As of June 30, 2026, we had $0.7 million of cash and cash equivalents. In August 2026, we acquired Cy Biopharma, Inc. and completed a private placement financing which together provided aggregate cash of approximately $31 million, net of transaction expenses. 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 candidate for several years, if at all.

Previous wording

We have funded our operations to date primarily with proceeds from the sale of common equity, exercise of warrants for common equity, funding under federal research grants and borrowings under convertible promissory notes. To fund future operations, we will need to raise additional capital. The amount and timing of future funding requirements will depend on many factors, including the timing and results of our ongoing research and development efforts and related general and administrative support. We anticipate that we will fund our operations through public or private equity or debt financings or other sources, such as potential collaboration agreements. We cannot make assurances that anticipated additional financing will be available to us on favorable terms, if at all.

Current wording

We have funded our operations to date primarily with proceeds from the sale of common and preferred equity, exercise of warrants for common equity, funding under federal research grants and borrowings under convertible promissory notes. To fund future operations, we will need to raise additional capital. The amount and timing of future funding requirements will depend on many factors, including the timing and results of our ongoing research and development efforts and related general and administrative support. We anticipate that we will fund our operations through public or private equity or debt financings or other sources, such as potential collaboration agreements. We cannot make assurances that anticipated additional financing will be available to us on favorable terms, if at all.

Previous wording

The remaining funding under the MPAR federal research grant totaled $6.0 million at March 31, 2026, 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 $5.3 million at June 30, 2026, 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 through late second quarter of 2026, 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 through late third quarter of 2026, which raises substantial doubt about our ability to continue as a going concern.

Previous wording

During the three months ended March 31, 2026 and 2025, we used cash in operating activities of $3.5 million and $1.7 million, respectively. The increase primarily resulted from the timing of vendor invoicing and payments, particularly related to the Phase 3 clinical trial for PF614.

Current wording

During the six months ended June 30, 2026 and 2025, we used cash in operating activities of $5.5 million and $4.4 million, respectively. The increase primarily resulted from the timing of vendor invoicing and payments, particularly related to the Phase 3 clinical trial for PF614.

Previous wording

During the three months ended March 31, 2026, net cash used in financing activities was $0.1 million, primarily from repayments of financed insurance premiums. During the three months ended March 31, 2025, net cash provided by financing activities was $1.3 million, primarily consisting of net proceeds from a public offering of common stock and warrant exercises.

Current wording

During the six months ended June 30, 2026, net cash used in financing activities was $1.8 million, primarily from $1.9 million of net proceeds from issuance of Series B Preferred Stock and $0.1 million repayments of financed insurance premiums. 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 exercise

Previous wording

Our commitments as of March 31, 2026, included an estimated $17.0 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 June 30, 2026, included an estimated $15.6 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.
Rearranged current paragraphs (2)

Current report — wording carried from elsewhere

Other income and expense for the three months ended June 30, 2026, consisted primarily of interest income from cash and cash equivalents.

Current report — wording carried from elsewhere

Research and development expenses for the six months ended June 30, 2026, and 2025 were $5.8 million and $3.8 million, respectively, representing an increase of $2.0 million. The increase was primarily the result of external research and development costs related to increased clinical activity for PF614.