Ensysce Biosciences Q1 2024 Financial Results

Ensysce Biosciences Inc. (NASDAQ: ENSC), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief with a reduced potential for opioid abuse and overdose, has announced its financial and operational results for the first quarter ending March 31, 2024. The company is advancing its clinical programs, particularly its lead opioid product, PF614, which received guidance from the FDA for Phase 3 clinical trials set to begin in the second half of 2024. Additionally, Ensysce's PF614-MPAR product has been granted Breakthrough Therapy designation by the FDA, a significant step aimed at expediting the clinical program and eventual regulatory approval.

Dr. Lynn Kirkpatrick, CEO of Ensysce, highlighted the progress made in the first quarter of 2024, emphasizing the company's efforts to accelerate clinical programs towards regulatory approvals. A constructive end-of-Phase 2 meeting with the FDA provided solid guidance for initiating a Phase 3 clinical trial for PF614. This phase is expected to commence in the latter half of 2024, and the FDA's guidelines aim to reduce regulatory risks associated with Ensysce's commercialization plan.

In January, the FDA granted Breakthrough Therapy designation for PF614-MPAR, recognizing the potential in the company's novel approach to developing next-generation opioid products. This designation, which is exclusive and rare, was based on data from the Phase 1 study, PF614-MPAR-101, demonstrating the product’s ability to provide oral overdose protection through its unique combination. The Breakthrough Therapy designation is designed to accelerate the development and approval process for drugs that show substantial improvement over existing therapies.

Dr. Kirkpatrick expressed optimism about the upcoming Phase 3 clinical trials, underlining that data from multiple clinical studies have reduced the risks associated with commercialization. These studies have confirmed that PF614 delivers oxycodone effectively while providing pain relief with a lower potential for abuse. Ensysce believes its TAAP and MPAR opioids have shown a promising safety profile, surpassing current extended-release opioid analgesics, with more milestones and updates anticipated in the coming months.

Ensysce's lead product, PF614, employs Trypsin-Activated Abuse Protection (TAAP) technology. This extended-release oxycodone is designed to be highly resistant to tampering and reduces abuse through a unique chemical modification. PF614 remains inactive until ingested, at which point it is activated by the body's trypsin enzyme in the small intestine, releasing oxycodone. The FDA's recent guidance has provided a clear strategy for the Phase 3 clinical program, with enrollment expected to begin in the second half of 2024.

Additionally, PF614-MPAR combines the TAAP prodrug PF614 with a trypsin inhibitor, offering overdose protection by preventing the release of the opioid in cases of excessive consumption. Clinical data over the past year have shown that the MPAR technology effectively reduces the release and absorption of oxycodone when taken in higher than prescribed doses. The FDA's Breakthrough Therapy designation for PF614-MPAR reflects the significance of this innovative overdose protection technology. The company has received further guidance to efficiently advance towards a new drug application (NDA) submission and approval.

From a financial perspective, Ensysce reported cash and cash equivalents of $3.4 million as of March 31, 2024, a substantial increase from $1.1 million at the end of 2023. This increase was primarily due to cash proceeds from the exercise of warrants and federal grants. Research and development expenses decreased to $0.8 million for the first quarter of 2024, compared to $1.8 million in the same period of 2023. General and administrative expenses also saw a slight decrease to $1.4 million from $1.6 million in the previous year. However, the net loss for Q1 2024 was $3.1 million, up from $2.2 million in Q1 2023, as the company continues to invest in its clinical and regulatory efforts.

Ensysce Biosciences remains committed to developing safer prescription drugs through its proprietary TAAP and MPAR platforms, offering unique, tamper-proof treatment options for severe pain that minimize the risk of abuse and overdose. The company's extensive worldwide intellectual property portfolio underpins its innovative product lineup, which aims to provide safer alternatives for pain management and reduce the risk of medication abuse-related deaths.