Ensysce Biosciences Inc. (ENSC)
NASDAQ (CM) NASDAQ (CM) Primary 
Ensysce Biosciences, Inc. (ENSC) Shareholder/Analyst Call Prepared Remarks Transcript
Ensysce Biosciences, Inc. (ENSC) Shareholder/Analyst Call Prepared Remarks Transcript
Ensysce Biosciences Issues Annual Shareholder Letter
~ 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.
Ensysce Biosciences Announces Commercial Supplier for Breakthrough Overdose Protection Drug Product
~ 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.
Ensysce Biosciences Announces Strategic Partnership for the Development and Commercial Launch of PF614 and PF614-MPAR
~ $10 Million Commitment from Specialty Drug Manufacturer to Support Commercialization Efforts ~ SAN DIEGO, CA / ACCESSWIRE / December 4, 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 initiation of a strategic partnership with a leading specialty drug manufacturer for the development and commercial launch of PF614 and PF614-MPAR drug products. This collaboration underscores a shared commitment to achieving swift regulatory approval and efficient development of the Company's innovative drug products.
Ensysce Biosciences Announces 1-for-15 Reverse Stock Split
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.
Ensysce Biosciences Completes Significant Milestone, Dosing First Subjects in Breakthrough Therapy PF614-MPAR Trial
~ Landmark Overdose Protection Clinical Trial of PF614-MPAR ~ ~ Expects Early Interim Data in 1Q 2025 ~ SAN DIEGO, CA / ACCESSWIRE / November 26, 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 treated its first group of subjects in the PF614-MPAR-102 study. PF614-MPAR received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and had its development bolstered by the recent $14 million multi-year award from the National Institute on Drug Abuse (NIDA).
Ensysce Biosciences Reports Third Quarter 2024 Financial Results
Awarded $14 Million Multi-Year NIH Grant and Initiated Second Clinical Trial for Breakthrough Therapy PF614-MPAR Submitted Pivotal PF614 Phase 3 Protocol to the FDA for Review SAN DIEGO, CA / ACCESSWIRE / November 12, 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 reported financial and operational results for the third quarter ended September 30, 2024. Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "Our team has made significant progress in the third quarter, and we have line of sight to meaningful clinical initiatives to close out the year.
Ensysce Biosciences Provides Shareholder Update, Responds to Recent Shareholder Inquiries
SAN DIEGO, CA / ACCESSWIRE / October 2, 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 provides a response from Chief Executive Officer, Dr. Lynn Kirkpatrick, regarding recent inquiries from stockholders and other interested parties. Dear Fellow Stockholders, It is important to me to directly deliver an update to our supportive shareholders, stakeholders and partners, by addressing some questions we have recently received and providing a concise view of our development progress and timelines.
Ensysce Biosciences Presenting at Upcoming Meetings
~ New Data on Opioid Use Disorder Program at Society for Neuroscience Meeting ~ ~ Ensysce CEO Invited Expert Speaker at Formulation & Delivery US 2024 Meeting ~ SAN DIEGO, CA / ACCESSWIRE / September 24, 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 its participation in two upcoming meetings in October 2024. October 5, 2024: New data will be presented in a poster session in collaboration with Sygnature Discovery at the Society for Neuroscience meeting in Chicago in the session for Addictive Drugs: Drug Tolerance, Dependence, and Toxicity.The poster entitled "Methadone ameliorates the effects of morphine withdrawal in a modified rat model of physical dependence" is the first study of its kind in a pre-clinical model to evaluate the efficacy of novel agents for treating Opioid Use Disorder (OUD).OUD affects 16 million people worldwide and can be attributed to 500,000 deaths each year.
Ensysce Biosciences Submits Phase 3 Protocol to the FDA
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.
Ensysce Biosciences Posts Video Updates from the IASP World Congress on Pain 2024
~ 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.
Ensysce Biosciences, Inc. Announces $5 Million Concurrent Registered Direct Offering and Exercise of Warrants
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.
