Ensysce launches Phase 3 trial for PF614, raises $4M, extends cash runway to Q2 2026

Filed March 30, 2026 · Period ending December 31, 2025 · Compared to 10-K Mar 10, 2025 · ~1 min read

Key Changes

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  Company initiated pivotal Phase 3 trial (PF614-301) for post-operative pain in July 2025 with enrollment beginning December 2025, advancing lead product to final pre-approval stage.

  Business: Phase 3 trial initiation verify on EDGAR →
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  Raised $4M via Series B Preferred and warrants in November 2025; extended cash runway from Q2 2025 to Q2 2026, though Nasdaq bid price deficiency notice received February 2026.

  MD&A: Series B Financing & Risk Factors: Nasdaq compliance verify on EDGAR →
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  R&D expenses jumped $3.2M year-over-year (to $10.4M) driven by accelerated PF614 and PF614-MPAR clinical programs; open purchase commitments increased from $12M to $18.7M.

  MD&A: R&D expenses & Commitments verify on EDGAR →