Ensysce Biosciences, Inc. - ENSC STOCK NEWS

Ensysce Biosciences has initiated the Bioequivalence (BE) study for its novel opioid, PF614, as a step towards FDA approval. This study will compare PF614 with OxyContin and aims to establish data supporting a 505(b)(2) regulatory path, allowing reference to existing safety data. Successful completion of this study is critical for PF614's market introduction, with results expected in the second quarter of 2022. The study builds on previous safety results and aims to demonstrate PF614's abuse protection features, enhancing prescription safety.

Ensysce Biosciences announced participation in the H.C. Wainwright BIOCONNECT Conference from January 10-13, 2022. CEO Lynn Kirkpatrick and CFO Dave Humphrey will engage in one-on-one meetings with investors. An on-demand presentation will be available on the company’s Investor Relations website starting January 10, 2022, at 7:00 am ET. Ensysce focuses on developing safer prescription drugs utilizing innovative technology platforms aimed at combating opioid abuse and overdose mortality.

Ensysce Biosciences has announced the successful completion of Part A of its Phase 1b clinical study PF614-102, assessing its novel opioid PF614 against OxyContin. All three dose levels were administered to healthy subjects with positive oversight from the Safety Review Committee. Following this, the study will progress to the Bioavailability/Bioequivalence stage, with results expected in Q2 2022. The trial aims to address the opioid crisis by developing a safer, abuse-deterrent treatment for severe pain. Preliminary pharmacokinetic data confirmed expected outcomes without adverse events.

Ensysce Biosciences has enrolled its first patients in a Phase 1 clinical study for PF614-MPAR, designed to provide safety and pharmacokinetics data. This product combines PF614, a trypsin-activated oxycodone prodrug, with nafamostat to offer abuse and overdose protection. Dr. Lynn Kirkpatrick highlighted the urgent need to address opioid abuse and overdose deaths, aiming for safer pain management solutions. The clinical trial is seen as a crucial step toward the development of this innovative product, potentially paving the way for future trials.

Ensysce Biosciences has completed a positive safety review for its PF614 opioid study, advancing to the highest dose cohort. The Phase 1b study will evaluate dosing safety and pharmacokinetics compared to OxyContin, with results expected in early 2022. PF614 aims to provide enhanced pain relief while minimizing abuse potential through its Trypsin Activated Abuse Protection technology. The company has bolstered its management team, achieved significant milestones, and secured funding for further clinical initiatives, positioning itself for continued success in the opioid market.

Ensysce Biosciences (NASDAQ: ENSC) reported its Q3 2021 financial results on November 15, 2021. The company completed a $15 million convertible note financing, enhancing its cash position to $6.8 million pre-financing. Key highlights include an increase in federal grants to $1.2 million and a rise in R&D expenses to $1.7 million due to clinical activities related to PF614. However, the company reported a net loss of $17.2 million, contrasting with a net income of $1.6 million in Q3 2020. Ensysce continues to develop opioid abuse deterrents and appointed Dr. Linda Pestano as Chief Development Officer.

Ensysce Biosciences has successfully completed a private placement for $15 million through senior secured convertible notes and warrants. The latest funding round closed on November 5, 2021, with $10 million raised. The convertible notes have a conversion price of $5.87, and the accompanying warrants allow for the purchase of common stock at $7.63. Funds will support the advancement of clinical trial programs, including critical studies related to opioid abuse prevention. This financing strengthens Ensysce's commitment to developing safer prescription drugs.

Ensysce Biosciences has appointed Linda Pestano, PhD, as Chief Development Officer effective October 15, 2021. Dr. Pestano brings over 20 years of experience in drug development and has worked on therapies for various indications. CEO Dr. Lynn Kirkpatrick highlighted her expertise as a boon for advancing their opioid products and addressing concerns in the opioid crisis. Ensysce is focused on developing safer prescription drugs through its proprietary platforms aimed at reducing abuse and overdose.

Ensysce Biosciences has secured a $15 million investment through a securities purchase agreement involving senior secured convertible notes and warrants. The initial $5 million was funded on September 24, 2021. The notes, convertible at $5.87, mature in 21 months, bearing 5% interest. Proceeds will support clinical programs, including studies on opioid treatment. CEO Dr. Lynn Kirkpatrick highlighted this financing as essential for combating the opioid crisis.