Secures Strategic Partnership for the Development and Commercial Launch of PF614 and PF614-MPAR Groundbreaking Trial on PF614-MPAR Generates Positive Interim Results SAN DIEGO, CA / ACCESS Newswire / March 10, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today reported financial and operational results for the fourth quarter and full year ended December 31, 2024. Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "Our team continued to make significant strides in the fourth quarter to deliver what we believe are the ‘Next Generation' opioid analgesics with both abuse and overdose protection.
SAN DIEGO, CA / ACCESS Newswire / March 5, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced its participation in the 37th Annual ROTH Conference being held Sunday, March 16th to Tuesday, March 18th at the Laguna Cliffs Marriott Resort in Dana Point, CA. Ensysce's Chief Executive Officer Dr. Lynn Kirkpatrick, Chief Financial Officer Dave Humphrey, and Chief Commercial Officer Geoff Birkett will be available to host one-on-one meetings with investors during the event.
~ 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.
SAN DIEGO, CA / ACCESSWIRE / December 3, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced that on Friday, December 6, 2024, effective at 12:01 a.m. Eastern Time, it will implement a 1-for-15 reverse split of its common stock.
Phase 3 Study to Assess PF614 Efficacy in Treating Post-Surgical Pain SAN DIEGO, CA / ACCESSWIRE / September 19, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced it has submitted to the FDA its PF614-301 protocol of the study, "A Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain after Abdominoplasty". Included in the Phase 3 study is the Company's statistical analysis plan for review and input by the FDA.
~ PF614 and PF614-MPAR Highlighted at Symposium on Severe Pain ~ SAN DIEGO, CA / ACCESSWIRE / September 13, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, has made available two video segments from its August 8th symposium at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain in Amsterdam, Netherlands. The Company's symposium emphasized opioid use worldwide, the current landscape for treating severe pain, including post-surgical and cancer pain treatment, and discussed Ensysce's innovative new class of opioid drug products.
SAN DIEGO, CA / ACCESSWIRE / August 29, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced that it has entered into definitive agreements, providing the Company with aggregate gross proceeds of $5 million, for the issuance and sale of an aggregate of 3,553,194 of its shares of common stock (or common stock equivalents in lieu thereof) at a purchase price of $0.47 per share (or common stock equivalent in lieu thereof) in a registered direct offering. The Company also entered into definitive agreements to exercise certain outstanding warrants to purchase up to an aggregate of 7,203,504 shares of common stock of the Company originally issued in February 2024, having an exercise price of $1.06 per share, at a reduced exercise price of $0.47 per share.
Next Clinical Trial of FDA Breakthrough Therapy PF614-MPAR Supported by $14 Million Federal Government Grant SAN DIEGO, CA / ACCESSWIRE / August 27, 2024 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced that it has received Investigational Review Board ("IRB") approval of the PF614-MPAR-102 protocol, ‘A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 when PF614 capsule is Co‑Administered with Nafamostat as a combination Immediate Release solution and Extended-Release Capsule Formulation in Healthy Subjects.' Ensysce has continued its collaboration with Quotient Sciences to conduct this second clinical study of MPAR using their Translational Pharmaceutics® platform.
NEW YORK, Aug. 23, 2024 (GLOBE NEWSWIRE) -- Diamond Equity Research, a leading equity research firm with a focus on small capitalization public companies has released an Update Note on Ensysce Biosciences, Inc. (NASDAQ: ENSC). The update note includes information on Ensysce Biosciences' business model, services, industry, financial results, valuation, and risks.