Ensysce Biosciences Inc
NASDAQ:ENSC
Ensysce Biosciences Inc
Ensysce Biosciences, Inc. is a clinical-stage biopharmaceutical company. The company is headquartered in La Jolla, California. The company went IPO on 2017-12-01. The firm is engaged in the development of small and large molecule drug delivery platforms targeting pain and cancer markets. Ensysce’s products include PF614 and PF614- Multi-Pill Abuse Resistant (MPAR). PF614 is a Trypsin-Activated Abuse Protection (TAAP) oxycodone prodrug that is a biologically inactive compound which can be metabolized in the body to produce a drug with demonstrable features aimed at resisting both oral and non-oral modes of prescription drug abuse. TAAP technology seeks to remove the ability of a user to abuse PF614 intravenously or intra-nasally. PF614-MPAR is a combination product of PF614 and nafamostat has designed to limit abuse potential by providing resistance to use through injection or inhalation and to provide overdose protection against excessive oral ingestion. Ensysce initiated a Phase I clinical trial for PF614-MPAR to evaluate safety and Pharmacokinetics in healthy.
Ensysce Biosciences, Inc. is a clinical-stage biopharmaceutical company. The company is headquartered in La Jolla, California. The company went IPO on 2017-12-01. The firm is engaged in the development of small and large molecule drug delivery platforms targeting pain and cancer markets. Ensysce’s products include PF614 and PF614- Multi-Pill Abuse Resistant (MPAR). PF614 is a Trypsin-Activated Abuse Protection (TAAP) oxycodone prodrug that is a biologically inactive compound which can be metabolized in the body to produce a drug with demonstrable features aimed at resisting both oral and non-oral modes of prescription drug abuse. TAAP technology seeks to remove the ability of a user to abuse PF614 intravenously or intra-nasally. PF614-MPAR is a combination product of PF614 and nafamostat has designed to limit abuse potential by providing resistance to use through injection or inhalation and to provide overdose protection against excessive oral ingestion. Ensysce initiated a Phase I clinical trial for PF614-MPAR to evaluate safety and Pharmacokinetics in healthy.
Clinical Milestones: Ensysce completed key Phase II studies and is preparing for pivotal Phase III trials of its lead opioid candidate PF614 in the second half of 2024.
Breakthrough Therapy: PF614-MPAR received FDA breakthrough therapy designation in January 2024, a rare status for opioid analgesics, recognizing its potential for overdose protection.
Cash Position: The company ended 2023 with $1.1 million in cash and has raised additional funds through warrant exercises, but current funding only extends into Q3 2024.
Further Funding Needed: Management said additional capital will be required before they can start Phase III trials for PF614.
Reduced Expenses: Research and development expenses declined sharply in 2023, reflecting a lull between major clinical activities.
