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About Ensysce Biosciences Inc.
Ensysce Biosciences Inc. (NASDAQ: ENSCW) is a clinical-stage pharmaceutical company dedicated to addressing the critical challenges of severe pain management while reducing the risks associated with opioid abuse and overdose. Leveraging its proprietary Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®) platforms, the company is pioneering innovative, tamper-proof prescription drug solutions designed to enhance safety and efficacy.
Core Technologies and Value Proposition
Ensysce's TAAP™ technology chemically modifies opioids, making them inactive until metabolized by trypsin, a natural enzyme in the small intestine. This unique mechanism ensures controlled release and deters common abuse methods such as crushing or injecting. Complementing this is the MPAR® platform, which provides an additional layer of protection by shutting down opioid release when excessive doses are ingested, effectively preventing overdose. Together, these platforms represent a significant advancement in opioid safety, addressing both intentional and accidental misuse.
Product Pipeline and Clinical Development
Ensysce's lead drug candidates, including PF614 and PF614-MPAR, are designed to treat severe pain with reduced abuse potential. PF614 is an extended-release oxycodone prodrug, while PF614-MPAR combines TAAP™ technology with overdose protection. Both candidates have received FDA designations such as Breakthrough Therapy and Fast Track, underscoring their potential to transform pain management. The company is also exploring applications of its TAAP™ platform in treating opioid use disorder (OUD) and other therapeutic areas.
Industry Context and Market Position
Operating within the pharmaceutical industry, Ensysce addresses the growing demand for safer opioid alternatives amid the ongoing opioid crisis. Its innovative technologies align with regulatory priorities to combat opioid misuse and improve patient safety. The company benefits from a robust intellectual property portfolio and substantial federal grant funding, which support its R&D efforts and clinical programs. Ensysce's strategic collaborations with manufacturing and research partners further position it for success in a competitive landscape.
Challenges and Competitive Differentiation
While navigating the complexities of clinical trials and regulatory approvals, Ensysce faces competition from other pharmaceutical companies developing abuse-deterrent formulations. However, its dual-layered approach to abuse and overdose protection sets it apart, offering a comprehensive solution that addresses multiple facets of opioid safety. The company's focus on innovation, combined with FDA recognition and federal support, enhances its credibility and market potential.
Commitment to Safer Prescription Drugs
Ensysce Biosciences is committed to providing safer options for patients suffering from severe pain. By integrating advanced abuse-deterrent and overdose-protection technologies, the company aims to reduce the societal and individual harms associated with opioid medications. Its groundbreaking work represents a critical step toward addressing the dual challenges of effective pain management and opioid safety.
Ensysce Biosciences has declared a dividend of 0.001 of a share of newly-designated Series A Preferred Stock for each outstanding share of common stock as of February 13, 2023. The Series A Preferred Stock will carry voting rights related to a reverse stock split and other specific matters. Each share will have 1,000,000 votes per share and will be automatically redeemed if not present at the stockholders' meeting. Ensysce is focused on developing safer prescription drugs using its proprietary technologies to minimize abuse and overdose risks. Detailed information about the Series A Preferred Stock will be released in upcoming SEC filings.
Ensysce Biosciences announces the initiation of the final stage of a Phase 1 study for PF614-MPAR, an innovative opioid with overdose protection features, aimed at enhancing pain management while reducing abuse risks. Conducted by Dr. Maria Bermudez at Quotient Sciences in Miami, this trial follows successful initial testing, demonstrating that PF614-MPAR can limit oxycodone release during overdose. With its dual safety mechanisms, PF614-MPAR is expected to address common abuse methods. CEO Lynn Kirkpatrick emphasizes the potential to revolutionize pain treatment with this breakthrough, targeting severely afflicted patients.
Ensysce Biosciences announced that CEO, Dr. Lynn Kirkpatrick, will present at the Diamond Equity Research 2023 Virtual Emerging Growth Invitational on January 25, 2023, at 12:20 p.m. Eastern Time. Ensysce, operating under the ticker symbols ENSC and ENSCW, is a clinical-stage biotech company developing tamper-proof prescription drugs to reduce abuse and overdose risk. The presentation will be followed by a Q&A session, and a live webcast will be available. Ensysce utilizes proprietary platforms, such as TAAP and MPAR, to create safer treatment options for severe pain.
Ensysce Biosciences (NASDAQ:ENSC) issued its 2023 shareholder letter, highlighting significant progress in clinical programs aimed at combating opioid abuse and overdose. The company reported positive clinical results and is advancing its lead product, PF614, through various studies. Ensysce's technology platforms, TAAP and MPAR, are designed to enhance drug safety while addressing the opioid crisis. Financially, the company secured $8 million via convertible notes and closed a $4.1 million public offering. Future clinical data is expected in early 2023, reinforcing Ensysce's commitment to improving prescription drug safety.
Ensysce Biosciences (NASDAQ:ENSC, OTC:ENSCW) announced the successful completion of its clinical study PF614-104, aimed at evaluating the oral abuse potential of PF614 compared to oxycodone. This study contributes to FDA abuse-deterrent labeling efforts. The trial involved 32 recreational drug users, assessing measures like 'drug liking.' Results are expected by March 2023. PF614 is designed to resist misuse, providing safer pain management. The company emphasizes its commitment to addressing opioid abuse while offering effective treatment alternatives.
Ensysce Biosciences has reported promising results from its clinical study of PF614-MPAR, aimed at providing overdose protection for opioid pain relief. Conducted by Dr. Maria Bermudez, the trial demonstrated that the product limits oxycodone release in cases of deliberate or accidental overdose due to its unique formulation with nafamostat. The study achieved its goal by showing comparable oxycodone delivery and exhibited reduced oxycodone uptake with higher doses of PF614-MPAR. Ensysce plans to further evaluate the product in early 2023, emphasizing its potential to save lives.
Ensysce Biosciences has priced an underwritten public offering of 2,900,000 shares of common stock and warrants to purchase up to 5,800,000 shares at an effective price of $1.40 per share. The offering is expected to yield gross proceeds of approximately $4.1 million, closing on or around December 9, 2022. Funds will be allocated as follows: 20% for repaying convertible notes and the remainder for clinical developments and working capital. Lake Street Capital Markets is the sole underwriter. A prospectus related to the offering has been filed with the SEC.
Ensysce Biosciences has completed the clinical portion of study PF614-MPAR-101 Part A, focusing on its innovative pain management product designed to reduce opioid overdose risk. The study evaluated the pharmacokinetics of oxycodone and PF614, alongside nafamostat, in healthy subjects. CEO Lynn Kirkpatrick emphasized the urgency of addressing opioid overdoses, revealing plans for further study in 2023 to enhance overdose protection. Ensysce's MPAR technology aims to mitigate abuse through a unique combination of a prodrug and a trypsin inhibitor, potentially revolutionizing treatment for severe pain.