Welcome to our dedicated page for Ensysce Biosciences news (Ticker: ENSC), a resource for investors and traders seeking the latest updates and insights on Ensysce Biosciences stock.
Ensysce Biosciences, Inc. (NASDAQ: ENSC) is a San Diego-based clinical-stage biotech company specializing in the development of safer prescription drugs using its proprietary technology platforms. The company focuses on creating new, tamper-proof opioids that aim to reduce drug abuse and prevent overdoses. Ensysce leverages its Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®) platforms to develop innovative pain relief options with a lower risk of misuse.
The company’s core projects include two key drug platforms: the TAAP technology, which activates upon ingestion to release pain medication, and the MPAR technology, designed to prevent overdose by inhibiting further release of the drug when excess doses are consumed. These platforms are supported by global intellectual property protection, ensuring a wide array of prescription drug compositions.
Recent milestones include the FDA’s Breakthrough Therapy designation for PF614-MPAR, a combination product designed to provide overdose protection alongside effective pain relief. This designation accelerates the drug’s development and review process, highlighting its potential to offer substantial improvements over existing therapies. Ensysce’s lead candidate, PF614, is currently in Phase 3 clinical development, having demonstrated efficacy and safety in previous trials.
In terms of financial health, Ensysce has shown stability, with recent funding from federal grants and warrant exercises supporting ongoing research and development. The company's collaboration with Quotient Sciences aims to further optimize their PF614-MPAR drug product, enhancing its effectiveness and safety profile.
Ensysce is also expanding its product pipeline to address opioid use disorder (OUD) with PF9001, a TAAP-based candidate that has shown promise in reducing cardiovascular side effects compared to traditional treatments. Supported by a multi-year HEAL grant from the NIH and NIDA, this candidate is poised to enter human clinical studies within the next 12 to 18 months.
For more detailed information about Ensysce Biosciences, Inc. and its innovative projects, please visit www.ensysce.com.
Ensysce Biosciences, Inc. (NASDAQ: ENSC) reported its 2022 financial results, highlighting significant clinical advancements in its PF614 and PF614-MPAR drug products aimed at improving prescription drug safety. The cash position decreased to $3.1 million by year-end, down from $12.3 million in 2021. Research and development expenses surged to $19.8 million for 2022 from $4.7 million the prior year, as Ensysce progressed towards Phase 3 trials. The net loss narrowed to $24.2 million from the previous year's $29.1 million, reflecting ongoing efforts to obtain regulatory approvals. A corporate update call is scheduled for April 11, 2023.
Ensysce Biosciences (NASDAQ:ENSC) has completed enrollment in the final stage of its Phase 1 clinical study for PF614-MPAR, an innovative opioid overdose protection product. The study aims to assess the safety and effectiveness of PF614-MPAR, designed to combat prescription drug abuse and accidental overdose. Initial findings indicate an exceptional safety profile with limited adverse events at various dose levels. The product combines PF614 with nafamostat, providing pain relief while reducing overdose risk. Data from this trial is expected in Q2 2023, potentially marking a significant advancement in pain management solutions.
Ensysce Biosciences announced Dr. Lynn Kirkpatrick's participation as a speaker at a seminar on March 22, 2023, in New York, highlighting the company's collaboration with Quotient Sciences. The seminar, part of DCAT Week, will showcase how the partnership has accelerated the development of Ensysce's overdose protection program, PF614-MPAR, which aims to combat opioid abuse. This unique platform integrates both abuse deterrence and overdose protection, potentially saving lives. The integration is facilitated by Quotient's Translational Pharmaceutics program, allowing real-time drug product evaluation.
Ensysce Biosciences (NASDAQ:ENSC) has locked its database for the oral Human Abuse Potential (HAP) study of PF614, a controlled-release oxycodone product, on February 24, 2023. This pivotal study is essential for obtaining Abuse Deterrent labeling from the FDA. Following unblinding on February 27, 2023, results are scheduled for release by the end of March 2023. The company leverages its Trypsin Activated Abuse Protection (TAAP) technology to develop safer pain management options that mitigate risks of abuse and overdose.
Ensysce Biosciences (NASDAQ: ENSC), a clinical-stage biotech company, issued a letter from CEO Dr. Lynn Kirkpatrick addressing shareholder questions. The company aims to improve drug safety, specifically focusing on opioid analgesics to combat the opioid crisis. Ensysce's unique technology chemically modifies opioids to reduce abuse potential. In 2022, the company initiated four clinical studies, achieving positive results in three, with expectations for upcoming data on the fourth study.
As of September 30, 2022, Ensysce had $4.5 million in cash and has taken measures to manage potential dilution and cash burn while advancing its clinical programs.
Ensysce Biosciences (NASDAQ:ENSC), a clinical-stage biotech company, announced on February 14, 2023, that the Nasdaq Hearings Panel granted its request for continued listing on the Nasdaq Stock Market. This decision is contingent on the company meeting criteria for the Nasdaq Capital Market tier, including a minimum bid price of $1.00 and stockholders' equity of at least $2.5 million by June 12, 2023. Ensysce focuses on innovative drug safety technologies to combat prescription medication abuse and overdoses through its proprietary platforms, TAAP and MPAR.
Ensysce Biosciences (NASDAQ:ENSC) announced that Geoff Birkett, Chief Commercial Officer, will present at the Annual NIH HEAL Meeting on February 22, 2023, in Washington, D.C. The HEAL initiative focuses on improving treatment strategies for opioid misuse and enhancing pain management. Ensysce will showcase its MPARTM platform, which includes PF614-MPAR, the first opioid with both abuse deterrent and overdose protection properties. Dr. Lynn Kirkpatrick emphasized the significance of federal support in advancing their mission to combat opioid abuse and potentially save lives.
Ensysce Biosciences (NASDAQ:ENSC) announced the closure of a registered direct offering, selling 3,571,431 shares at $0.84 per share, generating approximately $3.0 million in gross proceeds. A concurrent private placement involved issuing warrants for the same number of shares with an exercise price of $0.715, which are immediately exercisable.
The proceeds are intended for general corporate purposes including capital expenditures, working capital, and debt repayment. The shares were offered under a previously filed effective registration statement with the SEC, which also included a prospectus for investors.
Ensysce Biosciences, Inc. (NASDAQ:ENSC) announced a registered direct offering of 3,571,431 shares of common stock at $0.84 per share, totaling approximately $3 million in gross proceeds. Concurrently, the company will issue warrants for 3,571,431 shares with an exercise price of $0.715, exercisable immediately for five and a half years. The offering is expected to close around February 6, 2023, pending standard conditions. Proceeds will be utilized for corporate purposes, including capital expenditures, working capital, and debt repayment. H.C. Wainwright & Co. serves as the exclusive placement agent for this transaction.
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.
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