Ensysce Biosciences, Inc. (ENSC) Shareholder/Analyst Call Prepared Remarks Transcript
~ FDA Breakthrough Therapy designation received for PF614-MPAR ~ ~ PF614-MPAR second clinical trial initiated ~ ~ Lead clinical candidate identified for OUD program ~ ~ PF614 Phase 3 trial poised to commence 1H 2025 ~ SAN DIEGO, CA / ACCESSWIRE / January 8, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today issued a letter to shareholders from Chief Executive Officer, Dr. Lynn Kirkpatrick. Dear Fellow Shareholders, 2024 was underscored by outstanding progress for our two clinical programs, and I would like to thank you and all of our committed shareholders for their support over the last year.
~ Supply Chain Now Fully Secure for PF614-MPAR ~ SAN DIEGO, CA / ACCESSWIRE / December 10, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced the receipt of commitment of future supply of GMP nafamostat, a critical component of PF614-MPAR. This agreement fully secures the supply chain and allows Ensysce to reference the nafamostat Drug Master File of Aurore Life Sciences, a renowned specialty drug manufacturer.
| Biotechnology Industry | Healthcare Sector | D. Lynn Kirkpatrick CEO | NASDAQ (CM) Exchange | 293602108 CUSIP |
| US Country | 7 Employees | - Last Dividend | 6 Dec 2024 Last Split | 26 Feb 2018 IPO Date |
Ensysce Biosciences, Inc. is a clinical-stage pharmaceutical company based in La Jolla, California, dedicated to innovating prescription drugs aimed at addressing severe pain management while combating opioid misuse, abuse, and overdose in the United States. Since its inception in 2003, Ensysce has focused on leveraging advanced prodrug technology platforms, namely Trypsin Activated Abuse Protection (TAAP) and Multi-Pill Abuse Resistance (MPAR), to develop safer opioid-based medications. These platforms serve as the foundation for the company's drug development endeavors, targeting both pain relief and the mitigation of opioid abuse risks.
A pioneering product in development utilizing the TAAP technology, PF614 is designed as an abuse-resistant oxycodone prodrug for patients suffering from acute or chronic pain. This extended-release formulation aims to provide effective pain relief with a significantly reduced risk of abuse and overdose.
Building on the abuse-resistant properties of PF614, PF614-MPAR combines PF614 with nafamostat to offer enhanced protection against overdose through excessive oral ingestion. This combination product underscores Ensysce's commitment to developing safer opioid medications by integrating overdose protection mechanisms.
Alongside opioid-focused solutions, Ensysce is exploring the potential of nafamostat as an oral and inhalation therapeutic for combating coronaviral infections, including COVID-19, and other pulmonary conditions such as cystic fibrosis. This diversifies the company's portfolio into antiviral and respiratory treatments.
Ensysce is also developing PF329, an innovative product for pain management that embeds abuse protection features. This development signifies the company's ongoing efforts to introduce safer pain relief options into the market.
Expanding beyond pain management, Ensysce is working on PF8001 and PF8026, which are, respectively, extended and immediate-release prodrugs of amphetamine designed for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). These formulations aim to offer therapeutic efficacy while minimizing abuse potential.
With PF9001, Ensysce addresses opioid use disorder head-on, proposing an innovative treatment designed to offer relief from dependency within the framework of its abuse-deterrent technology. This initiative is part of the broader mission to provide comprehensive solutions in the realm of opioid management and treatment.