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Ensysce Biosciences — Third Quarter 2026 Earnings Summary

  • Financial Performance:

    • Cash and cash equivalents totaled $29.7 million as of September 30, 2026, an increase from $4.3 million as of December 31, 2025.
    • Net loss attributable to common stockholders was $82.3 million for the third quarter of 2026, compared to a net loss of $3.7 million in the same period of 2025.
    • Research and development expenses were $3.2 million for the third quarter of 2026, up from $3.0 million in the third quarter of 2025.
    • General and administrative expenses were $1.6 million for the third quarter of 2026, up from $1.3 million in the third quarter of 2025.
    • Federal grant funding totaled $2.2 million for the third quarter of 2026, compared to $0.5 million in the third quarter of 2025.
    • Net cash used in operating activities was $6.9 million for the first nine months of 2026.
    • Net cash provided by financing activities was $21.1 million for the first nine months of 2026, primarily driven by $19.6 million in net proceeds from a Series C private placement.
    • A one-time non-cash charge of approximately $79.9 million for acquired in-process research and development (IPR&D) related to CY200 was recorded in the third quarter of 2026.
    • Net loss per share attributable to common stockholders was $4.52 for the third quarter of 2026, compared to $1.29 in the third quarter of 2025.
    • Total assets were $30.95 million as of September 30, 2026, compared to $7.45 million as of December 31, 2025.
    • Total liabilities were $3.84 million as of September 30, 2026, compared to $4.57 million as of December 31, 2025.
  • Business Segments and Product Lines:

    • Completed the acquisition of Cy Biopharma, Inc., adding CY200, a clinical-stage neuroplastogenic candidate for Complex Regional Pain Syndrome (CRPS), as the lead pipeline asset.
    • CY200 is a psilocybin-predominant botanical extract with FDA Orphan Drug Designation for its active ingredient.
    • Submitted the Phase 2a protocol (CYBIO 001) for CY200 to the UK Medicines and Healthcare products Regulatory Agency (MHRA) in September 2026.
    • On November 6, 2026, the MHRA and research ethics committee requested additional information regarding the CY200 Phase 2a clinical trial application.
    • Completed enrollment in Part 3, the final stage of the PF614-MPAR-102 study for PF614-MPAR, a Breakthrough Therapy-designated opioid with overdose protection.
    • PF614-MPAR combines TAAP™ PF614 (trypsin-activated abuse protection) with MPAR® (Multi-Pill Abuse Resistance) technology.
    • The PF614-MPAR-102 study is funded by a $15.1 million multi-year NIDA award, with $2.7 million remaining available as of September 30, 2026.
    • Hosted a clinical symposium on severe pain and CRPS at PainWeek 2026 in September 2026.
    • Professor Richard Langford, CMO of Cy Biopharma, presented at the FDA's public hearing on "Considerations for Potential Future Therapeutic Use of Psychedelic Drugs."
  • Other Key Points:

    • The acquisition of Cy Biopharma added $11.4 million of net cash to the balance sheet.
    • Total other income for the third quarter of 2026 was $0.4 million, primarily consisting of foreign exchange gains from foreign subsidiaries acquired in the Cy Biopharma transaction.
    • A $0.2 million deemed dividend related to the retirement of Series B Preferred Stock was included in the third quarter 2026 net loss.
    • The company intends to use proceeds from recent private placement financings primarily to advance CY200 through the Phase 2a study and prepare for registrational development.
    • The company noted it is a clinical-stage biotechnology company and expects continued losses for the foreseeable future as it advances product candidates toward regulatory approval.
Company
ENSYSCE BIOSCIENCES INC
Sector
Healthcare
Industry
Biotechnology