ENSYSCE BIOSCIENCE WTS - ENSCW STOCK NEWS

Ensysce Biosciences (NASDAQ:ENSC), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing opioid abuse potential, provided a shareholder update. Key points include:

1. The company believes it's in compliance with Nasdaq requirements and awaits a hearing to discuss maintaining compliance.

2. Ensysce raised $5 million in gross proceeds and received a $14 million NIH grant.

3. The PF614-301 Phase 3 Protocol for a pivotal study was submitted to the FDA, with results expected in late 2025.

4. PF614-MPAR studies are progressing with non-dilutive funding.

5. The company aims to submit a New Drug Application for PF614 by 2026, with potential commercialization by year-end.

6. Ensysce is in discussions with potential partners to expand commercial success of PF614 and PF614-MPAR.

Ensysce Biosciences (NASDAQ:ENSC) has announced its participation in two upcoming meetings in October 2024. At the Society for Neuroscience meeting on October 5, new data will be presented on their Opioid Use Disorder (OUD) program, showcasing a study on methadone's effects in a modified rat model of physical dependence. This research, conducted with Sygnature Discovery, aims to develop novel methadone analogues with reduced cardiovascular side effects and abuse potential using Ensysce's Trypsin Activated Abuse Protection (TAAP) technology.

On October 16, Ensysce's CEO, Dr. Lynn Kirkpatrick, will present at the Formulation & Delivery US 2024 meeting, discussing their TAAP and MPAR platforms and highlighting their lead products, PF614 and PF614-MPAR. These products have received Fast Track and Breakthrough Therapy designations from the FDA, demonstrating their unique approach to delivering effective drugs more safely and efficiently.

Ensysce Biosciences (NASDAQ:ENSC) has released two video segments from its symposium at the International Association for the Study of Pain (IASP) 2024 World Congress in Amsterdam. The symposium focused on opioid use worldwide and Ensysce's innovative opioid drug products for severe pain relief. Dr. William Schmidt, CMO, explained the government support received from NIH and FDA, and highlighted how PF614, Ensysce's lead agent, aligns with ideal pain product characteristics. CEO Dr. Lynn Kirkpatrick emphasized the company's novel approach using TAAP and MPAR platforms to develop opioids with reduced abuse and overdose potential. Ensysce plans to begin a Phase 3 pivotal trial soon and explore PF614's use in cancer treatment, aiming to provide prescribers with new options for effective patient care.

Ensysce Biosciences (NASDAQ:ENSC) has received 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. This follows the FDA's Breakthrough Therapy designation for PF614-MPAR in January 2024. The funding will support the completion of the Phase 1b clinical trial, PF614-MPAR-102, over approximately three years.

PF614-MPAR is designed to provide optimal pain relief at prescribed doses while limiting accidental or intentional overdose. This grant brings the total federal funding awarded to Ensysce to $40 million, supporting their mission to develop innovative solutions for severe pain relief with reduced potential for opioid abuse and overdose.

Ensysce Biosciences (NASDAQ:ENSC) provides a mid-year 2024 update on its clinical-stage pharmaceutical developments for severe pain relief with reduced opioid abuse and overdose potential. Key highlights include:

1. PF614: Completed End of Phase 2 FDA meeting, published bioequivalence study results, and established manufacturing partnerships.

2. PF614-MPAR: Received FDA Breakthrough Therapy designation, applied for $15 million NIH/NIDA grant, and advanced to second clinical trial.

3. Opioid Use Disorder (OUD) program: Selected lead drug candidate PF9001, a TAAP methadone analogue with potentially lower cardiovascular side effects.

The company is finalizing the PF614 Phase 3 protocol and anticipates initiating enrollment later in 2024. Ensysce continues to seek non-dilutive federal funding to support its innovative pain relief solutions.

Ensysce Biosciences (NASDAQ:ENSC) announced it will host a symposium at the IASP 2024 World Congress on Pain on August 8, 2024, in Amsterdam. The symposium titled 'Severe Pain: A New Chapter for Safer Analgesics' will feature Dr. Lars Arendt-Nielsen and Dr. William Schmidt, who will discuss the landscape of severe pain treatment, trends in treatment, and the safety and effectiveness of Ensysce's PF614 and PF614-MPAR based on clinical data. CEO Dr. Lynn Kirkpatrick emphasized the importance of the event for presenting their technology platforms, TAAP and MPAR, which aim to reduce prescription drug abuse and overdose.

Ensysce Biosciences (NASDAQ:ENSC), a clinical-stage pharmaceutical company, announced a partnership with manufacturing expert Purisys to scale the production of its lead opioid use disorder (OUD) drug candidate, PF9001. Developed using Ensysce's TAAP technology, PF9001 aims to reduce the cardiovascular side effects commonly associated with methadone. This collaboration aims to expedite the drug's progression to IND studies. Ensysce is also advancing its pain treatment candidate, PF614, towards Phase 3 trials. CEO Dr. Lynn Kirkpatrick highlighted Purisys' expertise in controlled substance chemistry and its role in improving the manufacturing processes for PF614.

Ensysce Biosciences (NASDAQ: ENSC) has achieved a critical milestone in its opioid use disorder (OUD) program. The company has selected PF9001, a lead drug candidate designed to reduce abuse potential and improve safety, particularly with lower cardiovascular risks compared to traditional treatments. The candidate will proceed to Investigational New Drug (IND) enabling studies, backed by a $15 million NIH and NIDA HEAL award. CEO Dr. Lynn Kirkpatrick highlighted the adaptability of Ensysce's TAAP technology in producing controlled-activation drug candidates. Human clinical studies are expected to begin within 12 to 18 months.

Ensysce Biosciences announced that its Chief Commercial Officer, Geoff Birkett, will participate in the EPHMRA 2024 Annual Conference in London from June 24-27, 2024. Birkett will be part of the opening panel discussion on June 25, titled 'The Future of Healthcare Market Research,' and will lead a presentation on June 26 about customer engagement strategy development. Birkett, known for his expertise in market research and commercialization, is pivotal in preparing for the launch of Ensysce's lead product, PF614, and the innovative follow-on drug, PF614-MPAR, an opioid with oral overdose protection. His insights have been essential in advancing Ensysce's portfolio aimed at severe pain relief while mitigating opioid misuse and overdose.