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Ensysce Biosciences (ENSC) investor relations material

Ensysce Biosciences Q2 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q2 2025 earnings summary13 Aug, 2025

Executive summary

  • Lead product candidate PF614 is in Phase 3, with PF614-MPAR in Phase 1b and nafamostat completed Phase 1; no products approved or commercialized yet.

  • Initiated pivotal Phase 3 trial for PF614, aiming to validate superior pain relief with built-in abuse deterrence and overdose protection.

  • Fully enrolled Part 2 of PF614-MPAR-102 study, advancing overdose-protection opioid candidate.

  • Received $5.3 million NIDA grant installment to support overdose protection program.

  • Operating losses continue, with expectations for increased expenses as clinical programs advance and infrastructure expands.

Financial highlights

  • Cash and cash equivalents were $2.2 million as of June 30, 2025, down from $3.5 million at year-end 2024.

  • Net loss for Q2 2025 was $1.7 million, compared to $2.0 million in Q2 2024; net loss for the first half of 2025 was $3.7 million, down from $5.1 million in the prior year period.

  • Federal grant revenue was $1.4 million in Q2 2025, up from $0.2 million in Q2 2024, reflecting increased research activity.

  • Research and development expenses rose to $1.9 million in Q2 2025 from $0.9 million in Q2 2024, driven by clinical and preclinical activity.

  • Net cash used in operating activities was $4.4 million for the first half of 2025, with $3.1 million provided by financing activities.

Outlook and guidance

  • Expenses and capital requirements are expected to increase as clinical trials progress and infrastructure expands.

  • Without additional capital, current cash is sufficient to fund operations into the fourth quarter of 2025.

  • Advancing clinical and regulatory milestones for PF614, PF614-MPAR, and OUD programs in the second half of 2025.

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Frequently asked questions

Ensysce Biosciences Inc. is a clinical-stage pharmaceutical company focused on developing innovative drug delivery technologies aimed at improving safety in pain management. The company is known for its development of two proprietary platforms: the Trypsin Activated Abuse Protection (TAAP) and Multi-Pill Abuse Resistance (MPAR). These platforms are designed to reduce the risks associated with prescription opioid misuse, abuse, and overdose by enhancing the safety of oral drug delivery. Ensysce's product pipeline includes prodrug technologies that aim to provide effective pain relief while mitigating the potential for abuse and overdose. The company is headquartered in La Jolla, California, and its shares are listed on the NASDAQ under the ticker symbol ENSC.

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