Ensysce Biosciences Inc Stock Price, News & Analysis

Ensysce Biosciences (NASDAQ:ENSC) has announced positive results from a study evaluating the oral human abuse potential of its drug PF614. The study demonstrated that PF614 had significantly lower 'Drug Liking' scores compared to oxycodone at various doses, indicating reduced abuse potential. Key endpoints were met, showing PF614's lower scores at p<0.0001 and p=0.0025 for 'Overall Drug Liking'. This success paves the way for discussions with the FDA to initiate phase 3 trials. CEO Lynn Kirkpatrick expressed confidence in PF614's ability to address severe pain while minimizing abuse risks.

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 MPAR^TM 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.