Ensysce Biosciences Inc Stock Price, News & Analysis

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.

Ensysce Biosciences, a clinical-stage biotech firm, reported Q3 2022 financials highlighting a net loss of $9.9 million, a decrease from $17.2 million year-over-year. Cash reserves stood at $4.5 million, up from $3.7 million in the previous quarter. The CEO noted positive topline results from the human abuse potential study of PF614, indicating its advantages over existing products. Furthermore, the FDA provided guidance supporting PF614's development for acute pain. R&D expenses surged to $4.8 million, reflecting ongoing clinical activities.

Ensysce Biosciences (NASDAQ:ENSC) announced receiving FDA guidance regarding its lead product, PF614, indicating that pursuing an acute pain indication is advisable. The FDA's non-binding guidance suggests conducting two clinical trials comparing PF614 with a placebo and an immediate-release opioid like oxycodone. This strategy may reduce the development timeline and costs, compared to a chronic pain focus. Ensysce plans to advance PF614 for acute pain while continuing chronic pain development, aiming to complete human abuse potential studies and initiate Phase 3 trials in the upcoming year.

Ensysce Biosciences has announced positive topline results from a human abuse potential (HAP) study of PF614, an innovative oxycodone product designed to deter abuse. The study demonstrated that PF614 resulted in significantly lower peak 'drug liking' compared to traditional oxycodone. This is crucial for its FDA approval process, aligning with the agency's guidance on evaluating abuse potential. The company is committed to advancing this product into Phase 3 studies, addressing a significant need for safer analgesics in chronic pain management.

Ensysce Biosciences (NASDAQ:ENSC) has initiated the PF614-104 study, focusing on the drug's abuse deterrent properties against oxycodone. The trial tests the oral abuse potential of PF614 in non-dependent recreational opioid users, comparing it to oxycodone and placebo. The study's primary outcome is 'Drug Liking,' essential for future commercialization and labeling. Ensysce's TAAP® technology ensures PF614 is inert without trypsin exposure, potentially reducing abuse risks. Preliminary data is expected in early 2023, marking a significant step towards safer opioid alternatives.

Ensysce Biosciences has initiated the PF614-104 trial, a study to evaluate the oral abuse potential of its drug PF614 compared to oxycodone. Conducted by Dr. Brad Vince, this randomized trial aims to demonstrate that PF614 has less drug liking potential, crucial for its abuse deterrent labeling. This follows the company's previous Human Abuse Potential study, reflecting significant progress in PF614's development. With PF614 exhibiting bioequivalence to OxyContin and a longer half-life for sustained pain relief, results are expected in early 2023.

Ensysce Biosciences (NASDAQ:ENSC) announced its participation in the Benzinga All Access investor event on September 23, 2022. Dr. Lynn Kirkpatrick, CEO, will present at 9:20 AM Eastern time, followed by a Q&A session. The event will be available via a live video webcast, with an archived replay on the Benzinga YouTube Channel. Ensysce focuses on developing tamper-proof prescription drugs to enhance drug safety and combat abuse and overdose risks, leveraging its TAAP™ and MPAR™ technologies.