ADDED
Nasdaq may delist our common stock and/or our Public Warrants may not continue to trade on the Pink Limited Market operated by OTC Markets Group, Inc..
2025 Registered Direct Offering A definitive Securities Purchase Agreement with certain institutional investors, pursuant to which the Company agreed to issue and sell in a registered direct offering shares of common stock and pre-funded warrants for an aggregate amount of $1.1 million.
2025 March Warrant Offering An agreement by the Company to issue and sell unregistered warrants of Common Stock, Series A-5, and Series A-6 warrants to purchase shares of Common Stock.
2025 April Warrant Inducement The Company s April 2025 Inducement offer letter entered into with certain holders of existing warrants to purchase 630,376 shares of the Company s common stock (issued in March of 2025) and the issuance of new warrants exercisable for an aggregate of up to 1,260,752 shares of common stock with an exercise price of $1.90 per share.
ANDA Abbreviated New Drug Application API Active pharmaceutical ingredient AUC Area under the concentration time curve August Inducement Letter Inducement offer letter entered into with certain holders of existing warrants to purchase 480,234 shares of the Company s common stock (issued in February of 2024) to reduce the exercise price from $15.90 per share to $7.05 per share.
is a clinical stage pharmaceutical company that is developing a compound utilized in the Company s overdose protection program for the treatment of COVID-19 and 79.2%-owned subsidiary of the Company EMA European Medicines Agency Ensysce Ensysce Biosciences Inc.
Our pipeline has been developed over the course of more than twenty years of research and investment and includes three clinical-stage product candidates.
11 We initiated our pivotal Phase 3 trial, PF614-301, examining the efficacy of PF614 in post-operative acute pain following abdominoplasty in July 2025 and enrollment began in December 2025.
A second three-part trial, PF614-MPAR-102, began in December 2024 to examine a 100 mg dose of PF614-MPAR.
Parts 1 and 2 of the trial have been completed and Part 3 is currently ongoing.
REMOVED
Nasdaq may delist our common stock and/or our Public Warrants may not continue to trade on the OTC Pink Open Market.
ADFs Abuse deterrent formulations ADHD Attention deficit hyperactivity disorder ANDA Abbreviated New Drug Application API Active pharmaceutical ingredient AUC Area under the concentration time curve August Inducement Letter Inducement offer letter entered into with certain holders of existing warrants to purchase 480,234 shares of the Company s common stock (issued in February of 2024) to reduce the exercise price from $15.90 per share to $7.05 per share.
is a clinical stage pharmaceutical company that is developing a compound utilized in the Company s overdose protection program for the treatment of COVID-19 and 79.2%-owned subsidiary of the Company EB-ST Agreement Agreement and Plan of Merger, dated as of December 28, 2015, by and among Signature, SAQ, and EB EMA European Medicines Agency Ensysce Ensysce Biosciences Inc.
GAAP Generally Accepted Accounting Principles in the United States of America GCP Good Clinical Practices GMP Good Manufacturing Practices Hatch-Waxman Act or Hatch-Waxman Amendments Drug Price Competition and Patent Term Restoration Act of 1984 HHS United States Department of Health and Human Services IMPDs Investigational Medicinal Product Dossiers IND Investigational New Drug Investor Notes The 2021 Notes, 2022 Notes and 2023 Notes, collectively.
Securities and Exchange Commission Securities Act Securities Act of 1933, as amended Securities Purchase Agreement The Securities Purchase Agreement, dated as of September 24, 2021, June 30, 2022, October 23, 2023, or August 28, 2024 as the context dictates, by and between Ensysce and the institutional investors party thereto Signature Signature Therapeutics Inc.
Our pipeline has been developed over the course of 15 years of research and investment and includes three clinical-stage product candidates.
Next Steps An End of Phase 2 regulatory meeting was held on January 30, 2024.
The meeting clarified the non-clinical and clinical Phase 3 study plans for the further development of PF614 which are expected to initiate in mid-2025.
The study initiated in December 2024 and will continue through 2025.
For the year ended December 31, 2024, we received federal grant funding totaling $5.2 million consisting of $3.1 million from NIH related to the Phase 1 clinical trial for PF614-MPAR and $2.1 million from NIDA for preclinical development of our opioid use disorder-MPAR technology.