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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~ 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 Commercial Supplier for Breakthrough Overdose Protection Drug Product

~ $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 Strategic Partnership for the Development and Commercial Launch of PF614 and PF614-MPAR

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 Announces 1-for-15 Reverse Stock Split

~ 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 Completes Significant Milestone, Dosing First Subjects in Breakthrough Therapy PF614-MPAR Trial

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 Reports Third Quarter 2024 Financial Results

SAN DIEGO, CA / ACCESSWIRE / November 7, 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 that it has received notice from The Nasdaq Stock Market ("Nasdaq") as described in a decision dated November 5, 2024, that the Company may continue its listing on The Nasdaq Capital Market tier with an extension to November 14, 2024, to demonstrate compliance with the equity requirement in Listing Rule 5550(b)(1) as of September 30, 2024, with filing of its Form 10-Q. Additionally, the Company received an extension toDecember 19, 2024, to evidence compliance with the Minimum Bid Price in Listing Rule 5550(a)(2), all other applicable requirements and the Company's satisfaction of certain other interim conditions.

Ensysce Biosciences Receives Positive Nasdaq Listing Determination

~ Dr. Lynn Kirkpatrick to Present Latest Clinical Data for PF614 and PF614-MPAR ~ ~ Dr. William Schmidt to Deliver Opening Remarks as Summit Chair ~ SAN DIEGO, CA / ACCESSWIRE / October 8, 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 that Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, will present at the 18th Annual Pain Therapeutics Summit taking place on October 28 and 29, 2024 in Boston, MA. Dr.

Ensysce Biosciences Announces Leadership Team's Participation in the Annual Pain Therapeutics Summit

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 Provides Shareholder Update, Responds to Recent Shareholder Inquiries

SAN DIEGO, CA / ACCESSWIRE / September 27, 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, has received notice from the listing qualifications department staff of The Nasdaq Stock Market ("Nasdaq") stating that the Company has not regained compliance with Nasdaq Listing Rule 5550(a)(2) because the bid price for the Company's common stock has remained below $1.00 per share through the initial 180-day compliance period ended September 23, 2024. The Company is not eligible for a second 180-day period because it does not comply with the minimum stockholders' equity requirement for initial listing on The Nasdaq Capital Market.

Ensysce Biosciences Receives Notice from Nasdaq

~ 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 Presenting at Upcoming Meetings

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 Submits Phase 3 Protocol to 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.

Ensysce Biosciences Posts Video Updates from the IASP World Congress on Pain 2024

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.

Ensysce Biosciences, Inc. Announces $5 Million Concurrent Registered Direct Offering and Exercise of Warrants

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.

Ensysce Biosciences Announces IRB Approval for Key MPAR Study

~ Substantial Award Follows FDA Breakthrough Therapy Designation for PF614-MPAR ~ ~ Federal Grant Funding Awarded to Date Now at $40 Million ~ SAN DIEGO, CA / ACCESSWIRE / August 27, 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 receipt of a $14 million multi-year grant from the NIH and National Institute on Drug Abuse (NIDA) for the continued development of PF614-MPAR, an abuse-deterrent opioid with overdose protection that received Breakthrough Therapy designation from the FDA in January 2024. Funding from this award will be available over a period of approximately three years, allowing for the completion of the Phase 1b clinical trial, PF614-MPAR-102.

Ensysce Biosciences Receives $14 Million NIH Grant for Clinical Development of Novel Opioid with Overdose Protection

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.

Diamond Equity Research Releases Update Note on Ensysce Biosciences, Inc. (NASDAQ: ENSC)

PF614-MPAR Progressing to Phase 1b Study to Verify Both Overdose Protection and Effective Delivery of Oxycodone Opioid Use Disorder Program Advances with Selection of PF9001 as Lead Drug Candidate  PF614 Phase 3 Protocol Being Finalized for Submission to FDA  SAN DIEGO, CA / ACCESSWIRE / August 14, 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 second quarter ended June 30, 2024. Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "Our FDA-designated Breakthrough Therapy product candidate, PF614-MPAR, is a game-changer for Ensysce as we progress to a second clinical trial, PF614-MPAR-102.

Ensysce Biosciences Reports Second Quarter 2024 Financial Results

~ PF614 and PF614-MPAR Discussed in Satellite Symposium on Severe Pain ~ SAN DIEGO, CA / ACCESSWIRE / August 8, 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, provides a summary of its successful symposium at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain in Amsterdam, Netherlands. The Company's symposium illustrated the current landscape of severe pain, including post-surgical and cancer pain treatment, and discussed potential innovative treatment options, noting the limited number of new therapeutic agents approved in the last ten years.

Ensysce Biosciences Provides Key Themes Following IASP 2024 Symposium

~ Ready to Commence PF614 Phase 3 Clinical Trial in 2024 ~ ~ Continued Clinical Development of Overdose Protection Breakthrough Therapy ~ ~ Identified Lead Clinical Candidate for Opioid Use Disorder Program ~ SAN DIEGO, CA / ACCESSWIRE / July 23, 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 provides a Company review and update on a successful first half of 2024, including achievement of Breakthrough Therapy designation from the U.S. Food & Drug Administration (FDA). Recent clinical and development highlights: PF614: Successfully completed a PF614 End of Phase 2 meeting with the FDA, which provided guidance on strategy and design of the Phase 3 clinical program.

Ensysce Biosciences Provides Mid-Year 2024 Update

~ Dr. Lynn Kirkpatrick, CEO, to Introduce Satellite Symposium on Severe Pain: A New Chapter for Safer Analgesics ~ SAN DIEGO, CA / ACCESSWIRE / July 9, 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 the Company will host a symposium at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain on August 8, 2024 in Amsterdam, Netherlands. The Symposium entitled: ‘Severe Pain: A New Chapter for Safer Analgesics' will feature Dr. Lars Arendt-Nielsen, Professor of Aalberg University of Medicine, Denmark, and Dr. William Schmidt, Chief Medical Officer of Ensysce Biosciences, two leading authorities on pain, pain treatment and analgesic drug development.

Ensysce Biosciences Hosts IASP 2024 Symposium and Presents Clinical Dataset

~ Geoff Birkett, Chief Commercial Officer, Provides Insight Following EPHMRA Meeting ~ SAN DIEGO, CA / ACCESSWIRE / June 27, 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, provides takeaways from Geoff Birkett, the Company's Chief Commercial Officer, following his participation on the opening panel of the European Pharmaceutical Market Research Association (EPHMRA) Annual Conference in London on June 25. Geoff Birkett discussed "The Future of Healthcare Research" with industry partners and underlined the importance of new healthcare technologies to address key problems for patients and the companies that serve them.

Ensysce Biosciences Discusses Key Themes from the EPHMRA 2024 Annual Meeting

~ Collaboration with Purisys Positions Ensysce to Expedite Lead OUD Candidate, PF9001, to IND Studies ~ SAN DIEGO, CA / ACCESSWIRE / June 25, 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 an agreement with Purisys LLC ("Purisys") to scale the manufacture of the Company's lead opioid use disorder (OUD) drug candidate. PF9001, as recently announced, is a novel agent developed with Ensysce's unique TAAP technology to treat OUD that will potentially decrease the cardiovascular side effects associated with methadone.

Ensysce Biosciences Announces Partnership to Scale and Manufacture New Drug Candidate

~ Selects Lead Candidate with Abuse Deterrence and Improved Safety Profile to Treat Opioid Use Disorder ~ SAN DIEGO, CA / ACCESSWIRE / June 6, 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 misuse, abuse and overdose, today announced the achievement of a critical milestone in its opioid use disorder (OUD) program with the selection of a lead drug candidate to move into Investigational New Drug (IND) enabling studies. Designed with the application of Ensysce's TAAP platform to reduce the abuse profile, lead candidate PF9001 has shown lower potential for cardiovascular side effects associated with traditional methadone opioid use disorder (OUD) treatments.

Ensysce Biosciences Announces Major Milestone for Opioid Use Disorder Program

~ Geoff Birkett, Chief Commercial Officer, Invited to Serve on the Opening Panel at the EPHMRA 2024 Annual Conference ~ SAN DIEGO, CA / ACCESSWIRE / June 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 misuse, abuse and overdose, today announced that Geoff Birkett, the Company's Chief Commercial Officer, has been invited to present at the European Pharmaceutical Market Research Association (EPHMRA) Annual Conference in London on June 24-27, 2024. Geoff Birkett will participate in the EPHMRA opening panel discussion on Tuesday, June 25th titled "The Future of Healthcare Market Research".

Ensysce Biosciences to Participate in the EPHMRA 2024 Annual Meeting

New Study to Confirm Overdose Protection Across Full Dosage Range of Breakthrough Therapy Opioid PF614-MPAR SAN DIEGO, CA / ACCESSWIRE / May 20, 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 the renewal of its collaboration with Quotient Sciences to undertake the study PF614-MPAR-102 to examine and evaluate the full commercial dose range of the PF614-MPAR drug product. PF614-MPAR is the Company's Multi-Pill Abuse Protection (MPAR) unique combination opioid product which shuts off opioid release when too many pills are ingested, thereby stopping deliberate or accidental overdose.

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