ENSCNasdaqPharmaceutical PreparationsUS GAAP · USD

Ensysce Biosciences, Inc.

Ensysce Biosciences, Inc. is a clinical-stage pharmaceutical company developing abuse-deterrent and safer opioid-based pain therapies. Its core work centers on PF614 and PF614-MPAR, drug candidates designed to improve pain control while reducing misuse, overdose, and other safety risks.

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Revenue5.1m USD
−2.8 %y/y
Operating profit (EBIT)-10.2m USD
−52.2 %y/y
EBIT margin-202.1%
−72.9 ppy/y
Net income-10.2m USD
−27.4 %y/y
Free cash flow-7.9m USD

Fiscal year 2025 · change from previous year

Development 2020–2025

-30-20-10010m USD2020: EBIT -1.4 m USD20202021: EBIT -20 m USD20212022: 2.5 m USD2022: EBIT -24 m USD20222023: 2.2 m USD2023: EBIT -11 m USD20232024: 5.2 m USD2024: EBIT -6.7 m USD20242025: 5.1 m USD2025: EBIT -10 m USD20255.1-10
RevenueOperating profit (EBIT)
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Business

Share of revenue
Drug Candidates70 %

Proprietary therapeutic programs in development, centered on PF614 and PF614-MPAR.

Development Services30 %

Research, formulation, and pre-commercial development work tied to its pipeline.

Products

Reported · share of revenue
59.2%40.8%FY2024100 %
  • MPAR59.2 %
  • TAAPOUD40.8 %

Source: 10-K FY2024, revenue the company reports per product line (SEC XBRL). Shares are of the lines shown and add up to 100 %.

Customers

The company primarily serves pharmaceutical development partners, manufacturing collaborators, and future healthcare prescribers and patients if its candidates reach commercialization. In the near term, value is driven by research and development counterparties such as Galephar Pharmaceutical Research, which supports manufacturing and testing activities under project agreements.

Pharmaceutical development partners

Partners that fund, co-develop, or manufacture PF614 and PF614-MPAR programs.

Clinical and regulatory ecosystem

Clinical investigators, CROs, and regulators involved in advancing candidates through trials.

Future pain-treatment prescribers

Physicians and healthcare systems that would prescribe the products if approved.

Patients with chronic or acute pain

End users of the eventual approved therapies, especially where abuse deterrence matters.

Strategy

The company’s strategy is to advance PF614 and PF614-MPAR through development while using external partners to support manufacturing and testing. The January 2025 agreement with Galephar indicates a capital-efficient approach that shifts part of development execution to a specialized partner while preserving ownership of the programs.

Advance PF614 and PF614-MPAR developmentShort term

Clinical and regulatory progress is the main value driver for a pre-commercial biotech.

Outsource manufacturing and testing executionShort term

Partnering can reduce fixed costs and speed technical development.

Maintain financing flexibilityMedium term

Development-stage companies need capital to fund trials and operations before product revenue.

Geography

Ensysce is headquartered in the United States and its business is centered on U.S.-based development, financing, and regulatory activity. The recent Galephar agreement adds Puerto Rico manufacturing and development support, showing that operational execution can extend beyond the mainland U.S. as the pipeline advances.

Risks

Ensysce faces the typical risks of a clinical-stage pharmaceutical company: trial failure, regulatory setbacks, and the possibility that its candidates never reach commercialization. Its dependence on external funding and partner execution adds dilution, counterparty, and development-timing risk, while opioid-focused programs also face heightened scrutiny around safety, abuse deterrence, and market acceptance.

Sorted by severity
Pipeline development failureCritical

The company’s value depends heavily on PF614 and PF614-MPAR advancing successfully.

ExposurePF614PF614-MPAR
Financing and dilution riskHigh

Development-stage biotech companies often rely on equity or equity-linked funding.

ExposureShare issuanceMilestone-based consideration
Regulatory and clinical trial riskHigh

Drug candidates can be delayed, rejected, or require additional studies.

ExposureFDA reviewClinical endpointsSafety data
Counterparty and execution riskMedium

Manufacturing and testing are partly outsourced, so partner performance affects timelines.

Exposure: Galephar agreement

Opioid market and reputational riskMedium

Opioid therapies face heightened safety, legal, and adoption barriers.

Exposure: Abuse-deterrent pain products

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Accounting

Judgemental items
Research and development expense recognition

Clinical and manufacturing development costs are typically expensed as incurred, driving operating losses.

Impact: Affects reported loss level and comparability across periods

Equity-based consideration in the Galephar agreement

Restricted shares and share-settled milestone payments require valuation and expense recognition.

Impact: Can increase noncash expense and dilute shareholders

Contingent milestone obligations

Payments tied to development milestones may need accruals depending on probability and measurement.

Impact: Can affect liabilities and period-to-period expense timing

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Last updated: 24/09/2026