Ensysce Biosciences

Ensysce Biosciences, Inc. is a clinical-stage biopharmaceutical company, which engages in the development of solutions for severe pain relief while reducing the fear of and the potential for misuse and overdose. The firm's Trypsin Activated Abuse Protection and Multi-Pill Abuse Resistance platforms are in the process of developing a new class of powerful, tamper-proof opioids that prevent both drug abuse and overdoses. The company was founded in April 2003 and is headquartered in La Jolla, CA.

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Corporate Update Call to be Held Thursday, March 21, 2024 at 11:00am ET to Discuss Recent FDA Breakthrough Therapy Designation and Phase 3 Clinical Plans SAN DIEGO, CA / ACCESSWIRE / March 15, 2024 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today reported financial results for the fourth quarter and full year of 2023. Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "We are proud of the significant progress Ensysce has made in 2023 both operationally and clinically for our lead pain therapeutic, PF614, and our overdose protection product, PF614-MPAR.

Ensysce Biosciences Reports Fourth Quarter and Full Year 2023 Financial Results

~ PF614-MPAR program receives FDA guidance ~ SAN DIEGO, CA / ACCESSWIRE / February 21, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage company applying transformative chemistry to improve prescription drug safety, is providing an update following its recent meeting with the Food and Drug Administration (FDA) regarding its second product, a ‘Next Generation' opioid analgesic with overdose protection, PF614-MPAR. The meeting focused on the Company's non-clinical program for the combination product that is designed for the treatment of severe pain.

Ensysce Biosciences Announces Successful Meeting with FDA for PF614-MPAR, a Next Generation Opioid with Overdose Protection

Publication Details Positive Results of Clinical Study PF614-102 SAN DIEGO, CA / ACCESSWIRE / February 15, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC)(OTC PINK:ENSCW) ("Ensysce" or "Company"), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced online publication of its manuscript entitled, "Clinical evaluation of PF614, a novel TAAP(TM) prodrug of oxycodone, versus OxyContin® in a multi-ascending dose study with a bioequivalence arm in healthy volunteers" published online by the open-access medical journal Clinical and Translational Science (CTS) sponsored by the American Society of Clinical Pharmacology and Therapeutics (ASCPT). The article is authored by members of the Ensysce team plus external experts; D.

Ensysce Biosciences Announces Publication of Clinical Bioequivalence Manuscript

SAN DIEGO, CA / ACCESSWIRE / February 13, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) (the "Company"), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety to reduce abuse and overdose, today announced the entry into definitive agreements for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 3,601,752 shares of common stock of the Company originally issued in May 2023, having an exercise price of $3.637 per share, at a reduced exercise price of $1.31 per share. The shares of common stock issuable upon exercise of the warrants are registered pursuant to an effective registration statement on Form S-1 (No.

Ensysce Biosciences, Inc. Announces Exercise of Warrants for $4.7 Million Gross Proceeds

~ PF614-MPAR recognized as potential medical breakthrough ~ SAN DIEGO, CA / ACCESSWIRE / February 6, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or "Company"), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced they have been selected to present one of the top 12 best Flash Talks in the Trailblazer Session at the 2024 American Association of Pain Medicine (AAPM) Meeting on March 9th. Dr. William Schmidt, Chief Medical Officer of Ensysce, will present "Preventing Prescription Drug Overdoses: Clinical development of Trypsin-Activated Abuse Deterrent (TAAP) Opioids with Overdose Protection".

Ensysce Biosciences Selected to Present at American Association of Pain Medicine Annual Conference

~ PF614 Phase 3 Program Expected to Begin Enrollment in Mid-2024 ~ SAN DIEGO, CA / ACCESSWIRE / January 31, 2024 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced the completion of a constructive End of Phase 2 meeting with the Food and Drug Administration (FDA) regarding its lead ‘Next Generation' analgesic, PF614. The meeting facilitated an affirmation of the Company's non-clinical program and enabled an exchange of constructive ideas regarding Ensysce's Phase 3 clinical trial designs for PF614.

Ensysce Biosciences Announces Positive End of Phase 2 Meeting with FDA for PF614 to Treat Severe Pain

SAN DIEGO, CA / ACCESSWIRE / January 25, 2024 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety to reduce abuse and overdose, today announced that Geoff Birkett, Chief Commercial Officer of Ensysce, will present a poster entitled "PF614-MPAR: A Novel Trypsin Activated Abuse Protected (TAAP™) Extended-Release Oxycodone Prodrug with Overdose Protection" at the Annual National Institutes of Health (NIH) "Helping to End Addiction Long-term" (HEAL) Initiative Scientific Meeting being held on February 7 and 8, 2024, in Bethesda, MD. PF614-MPAR, the lead product under Ensysce's oral overdose protection platform, MPAR® (Multi-Pill Abuse Resistance), was just granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) and has been supported by funding from the National Institute on Drug Abuse (NIDA).

Ensysce Biosciences to Present Groundbreaking Oral Overdose Protection for Opioids at the 5th Annual NIH HEAL Meeting

~ FDA acknowledges significant potential impact of MPAR's oral overdose protection ~ SAN DIEGO, CA / ACCESSWIRE / January 23, 2024 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced receipt of notice from the U.S Food and Drug Administration (FDA) that it has granted Breakthrough Therapy Designation (BTD) for PF614-MPAR. A next generation opioid, PF614-MPAR represents a major scientific innovation, as it is what we believe to be the first product with oral overdose protection in any drug class.

Ensysce Biosciences Announces FDA Breakthrough Therapy Designation Granted for PF614-MPAR

SAN DIEGO, CA / ACCESSWIRE / January 8, 2024 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today issued a letter to shareholders from Chief Executive Officer, Dr. Lynn Kirkpatrick. Dear Fellow Shareholders, I am very pleased to provide you with an update on the outstanding progress we made over the last year and to extend sincere thanks from the Ensysce team for your ongoing support.

Ensysce Biosciences Issues 2024 Shareholder Letter

SAN DIEGO, CA / ACCESSWIRE / December 19, 2023 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), today announced that the Company's Special Meeting of Stockholders (the "Special Meeting") to be held on December 20, 2023 at 9:00 a.m. Pacific Time has been postponed due to lack of the required quorum.

Ensysce Biosciences Postpones Special Meeting of Stockholders to December 29, 2023

Results Reinforce Efficacy of PF614 as a Next Generation Analgesic with Significant Pain Intensity Reduction PF614 Clinical Data Primes FDA Evaluation and Design of Phase 3 Studies in 2024 SAN DIEGO, CA / ACCESSWIRE / December 14, 2023 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced that its most recent study has demonstrated crucially important data for PF614 on pain intensity efficacy and speed of onset. The PF614-201 study, ‘A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy Male Subjects', which completed enrollment in November 2023, demonstrated time-to-efficacy onset for the analgesia effect and significant decrease of pain intensity versus placebo of PF614 at two different dose levels, the first ever measured for this TAAP opioid.

Ensysce Biosciences Announces Key Efficacy Data for Lead Analgesic

PHOENIX, AZ / ACCESSWIRE / December 11, 2023 / The Stock Day Podcast welcomed Ensysce Biosciences (NASDAQ:ENSC) ("the Company"), a clinical-stage company using its proprietary technology platforms to develop safer prescription drugs.CEO of the Company, Dr. Lynn Kirkpatrick, joined Stock Day host Matthew Dunehoo. Dunehoo began the interview by asking about the Company's background and current projects.

Ensysce Biosciences Discusses TAAP and MPAR(R) Applications and OncoZenge Partnership with The Stock Day Podcast

Additional Funding from Investors Validates Company's Mission SAN DIEGO, CA / ACCESSWIRE / November 29, 2023 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, announced today that it has completed its previously announced private placement under a securities purchase agreement (the "SPA") with investors ("Investors") for senior secured convertible notes (the "Notes") and warrants exercisable for Ensysce common stock (the "Warrants") for an aggregate investment of $1.7 million. The second funding by the Investors of $1,333,333.33, prior to fees and offering expenses, was dated as of November 28, 2023, with funds received in full on November 29, 2023.

Ensysce Biosciences Announces Completion of $1.7 Million Convertible Note Financing

Collaboration Aims to Accelerate Development of BupiZenge™, a Novel Pain Treatment for Oral Mucositis Associated with Cancer Treatment SAN DIEGO, CA and STOCKHOLM, SWEDEN / ACCESSWIRE / November 28, 2023 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, and OncoZenge AB ("OncoZenge") (STO:ONCOZ), a clinical-stage company developing a transformative treatment for oral pain, are pleased to announce today that they have signed a letter of intent (LOI) to explore a strategic collaboration to accelerate the commercialization of BupiZenge™ in the United States. BupiZenge™ is OncoZenge's novel approach to treating pain caused by oral mucositis, an often severely debilitating condition of painful swelling and ulcerations of the mouth that commonly results from head and neck radiation and/or chemotherapy used to treat cancer.

Ensysce Biosciences and OncoZenge Announce Letter of Intent for the Co-development of BupiZenge(TM) in the United States

~ Enrollment Completion Signifies Critical Progress to Phase 3 of PF614 ~ ~ Trial Results Expected in December 2023 ~ SAN DIEGO, CA / ACCESSWIRE / November 16, 2023 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced that the PF614-201 study, ‘A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy Male Subjects' has completed enrollment. The goal of this exploratory Phase 2 PF614-201 study is to confirm the approximate time of onset for PF614 analgesic effects prior to initiation of Phase 3 efficacy evaluations.

Ensysce Biosciences Announces Enrollment Completion for PF614-201 Clinical Study

PF614-201 Clinical Study Results Expected by End of Year SAN DIEGO, CA / ACCESSWIRE / November 9, 2023 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today reported financial results for the third quarter of 2023. Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "We continue to execute steps toward meeting our near-term objective of entering Phase 3 evaluation of PF614 with a long-term goal of commercialization.

Ensysce Biosciences Reports Third Quarter 2023 Financial Results

Additional Funding from Investor Cohort Validates Company's Mission SAN DIEGO, CA / ACCESSWIRE / October 24, 2023 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC)(OTC PINK:ENSCW), a clinical-stage company applying transformative chemistry to improve prescription drug safety, announced today that it has entered into a securities purchase agreement (the "SPA") with investors ("Investors") in the form of senior secured convertible notes (the "Notes") and warrants exercisable for Ensysce common stock (the "Warrants") in a private placement for an aggregate investment of $1.7 million. The initial closing is expected to occur on or before October 26th and will raise $566,667, prior to fees and offering expenses.

Ensysce Biosciences Secures $1.7 Million Convertible Note Financing

Poster Presentation to Showcase the Optimization Process of Ensysce's PF614-MPAR Formulation SAN DIEGO, CA / ACCESSWIRE / October 18, 2023 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or "Company"), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced Dr. Dolly Jacob, Director Integrated Development Services of Quotient Sciences, will present the collaborative work of Ensysce and Quotient Sciences in the poster titled, "Development of an extended release nafamostat formulation for prescription drug overdose protection" at the American Association of Pharmaceutical Scientists (AAPS) 2023 PharmSci 360 event on Wednesday, October 25, 2023, in Orlando, FL. The AAPS PharmSci 360 event highlights the end-to-end drug discovery and development process through five detailed tracks from Discovery and Basic Research through Manufacturing, Formulation and Delivery.

Ensysce Biosciences Announces Poster Presentation at the AAPS 2023 PharmSci 360

~ A showcase of PF614 and PF614-MPAR ~ SAN DIEGO, CA / ACCESSWIRE / October 13, 2023 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or "Company"), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced it has posted to the Company's Corporate and Investor Relations website a video highlighting its PAINWeek Symposium entitled, "Severe Pain, Next Generation Solutions: PF614 / PF614-MPAR" held in Las Vegas on Sept 7, 2023. The "Highlights Video" features Dr. Jeff Gudin, University of Miami, School of Medicine Faculty of Anesthesiology and Pain Management, Dr. Richard Dart, Director of the Rocky Mountain Poison and Drug Center, and Dr. William Schmidt, Chief Medical Officer of Ensysce Biosciences, three leading authorities on pain, opioid use and drug development, and their perspectives of PF614 and PF614-MPAR treatments as well-positioned to become the ‘next generation' of analgesics.

Ensysce Biosciences Releases "Highlights Video" of PAINWeek 2023 Symposium

~ Dr. William Schmidt to Deliver Opening Remarks as Summit Chair ~ SAN DIEGO, CA / ACCESSWIRE / October 11, 2023 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or "Company"), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced that Dr. William Schmidt, Chief Medical Officer of Ensysce, will serve as Chairperson of the 17th Annual Pain Therapeutics Summit taking place on October 19 and 20, 2023 in San Diego, CA. Dr. Schmidt's extensive career and distinct expertise in leading clinical studies of novel pain management drugs provides a strong foundation to Chair the summit on Thursday, October 19, 2023.

Ensysce Biosciences Chief Medical Officer to Chair the 17th Annual Pain Therapeutics Summit

~ Geoff Birkett, CCO of Ensysce, to Chair Meeting, Deliver Opening Remarks and Present a Case Study on Drug Launch Process ~ SAN DIEGO, CA / ACCESSWIRE / October 3, 2023 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or "Company"), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced that the Company will present at the Fierce New Product Planning Summit 2023 taking place October 16 and 17, 2023 in Boston, MA. Ensysce Chief Commercial Officer, Geoff Birkett, will Chair and deliver Opening Remarks to commence the meeting on Monday, October 16, 2023, followed by a presentation on Tuesday, October 17, 2023, outlining best practices for launching a new drug product.

Ensysce Biosciences to Chair the Fierce New Product Planning Summit 2023

~ Study Initiation Brings PF614 One Necessary Step Closer to Phase 3 ~ ~ Trial Results Expected Before Year End 2023 ~ SAN DIEGO, CA / ACCESSWIRE / September 26, 2023 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced the Site Initiation Visit (SIV) was completed for the PF614-201 study, ‘A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy Male Subjects' to evaluate time of onset for PF614. The study is being conducted by Dr. George Atiee at Dr. Vince Clinical Research (DVCR) in Overland, KS.

Ensysce Biosciences Announces Completion of Site Initiation Visit for PF614-201 Clinical Study

~ Moderated Session to Review Latest Data as Recently Presented ~ SAN DIEGO, CA / ACCESSWIRE / September 19, 2023 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced they will host a Research and Development ("R&D") FAQ Session to discuss educational session held at PAINWeek where they presented their approach to delivering the Next Generation of analgesics. The Symposium "Severe Pain - Next Generation Solutions - PF614/ PF614-MPAR" featured experts in pain management and prescription drug abuse, Dr. Jeff Gudin from the University of Miami, and Dr. Richard Dart from the Rocky Mountain Poison and Drug Center in Denver, as well as Dr. William Schmidt, Chief Medical Officer of Ensysce who expanded on the recent developments with PF614 and PF614-MPAR.

Ensysce Biosciences to Host Research and Development FAQ Session Following PAINWeek Symposium on September 21, 2023

~ Positioning Company to Commence Commercialization Strategy ~ SAN DIEGO, CA / ACCESSWIRE / September 14, 2023 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced that two scale up manufactures have been completed for the Company's lead drug candidate PF614, a next generation pain medicine to treat severe pain. The success of the scaled manufacturing work has positioned the Company to begin its commercialization strategy consistent with timeline expectations.

Ensysce Biosciences Completes Scale Up Manufacture of PF614 to Support Phase 3 Studies

~ Leading Experts Presenting New Clinical Approaches to Treat Severe Pain at PAINWeek Symposium ~ SAN DIEGO, CA / ACCESSWIRE / September 7, 2023 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, is presenting clinical data at PAINWeek, the leading US pain conference, today, September 7, 2023, in Las Vegas, NV. America remains gripped by the opioid epidemic and this is creating another looming crisis: patients deprived of access to medication for severe pain.

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