On August 11, 2022 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC, OTC PINK:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety and performance focused on reducing abuse and overdose, reported financial results for the second quarter 2022 (Press release, Ensysce Biosciences, AUG 11, 2022, View Source [SID1234618213]).

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Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "With a recently completed $8 million financing, we are well positioned to advance our clinical trials. We also just announced that we achieved our stated milestone of positive bioequivalence (BE) study data from trial PF614-102 of our novel ‘TAAP’ opioid PF614. This study provides significant evidence of the progress we have made towards seeking to bring to market an important therapeutic option for pain management. Ultimately, the advances in our PF614 clinical development are the building blocks that enable our platforms to fully support our mission of developing a unique pipeline of safer pain products and helping millions who experience severe pain. To conclude, I want to thank all our constituents for their continued support."

TAAPTM (Opioid Abuse Deterrent Program) Updates

On July 27, 2022, the Company announced positive bioequivalence (BE) study data of its novel TAAP opioid PF614 from clinical trial PF614-102.
Study PF614-102 found that PF614 conformed to the FDA bioequivalence acceptance criteria when compared to OxyContin under both fasted and fed conditions.
The Company believes that the BE data from this study will support the 505(b)(2) regulatory path for clinical development of PF614, an abbreviated pathway to FDA approval. This pathway allows reference to available safety and clinical data from an approved product, and the BE data established by this study will move PF614 closer to registration. This positive BE data should allow the company to meet and communicate its Phase 3 plans with the FDA in 2023.
This PF614-102 study builds on the safety and pharmacokinetic results of the PF614 Phase 1 and 1b (Part A) studies and demonstrates the advantages we believe PF614 has over OxyContin, including a longer half-life, the limited food effect and the ability to deliver PF614 as an oral solution without losing its abuse deterrent properties for those who may have trouble swallowing.
This data is critical to understand future prescribing criteria for PF614 as an agent bioequivalent to OxyContin and the ability to substitute the use of PF614 for OxyContin.
PF614 is designed as an abuse-protected agent with trypsin-activated abuse protection (TAAP). TAAP chemical modification controls the release of the active ingredients in Ensysce’s opioid products including PF614, ‘turning on the release’ when exposed to trypsin. TAAP provides abuse protection and resistance to manipulation and other forms of recreational drug abuse.
MPARTM (Opioid Abuse Deterrent and Overdose Protection Program) Updates

On June 27, 2022, the Company announced its notice of award for the 4th year of funding for its Multi-Pill Abuse (MPAR) platform to support the final part of the ongoing clinical trial PF614-MPAR-101.
The amount awarded was $2.8 million and this brings total funding from NIDA under this grant to $10.8 million.
PF614-MPAR is a combination product with both trypsin-activated abuse protection (TAAP) and overdose protection through multi-pill abuse resistance (MPAR) technology. TAAP chemical modification controls the release of the active ingredient in PF614 providing abuse deterrence, and MPAR turns off the release in an overdose situation, providing the additional layer of protection.
Initial clinical data from PF614-MPAR-101 reported previously provided the first human data demonstrating the overdose protection of PF614-MPAR. The ongoing study will allow perfection of the drug product and aid in bringing this first overdose protected opioid to the market.
Financial Results

Cash – Cash and cash equivalents were $3.7 million as of June 30, 2022, as compared to $8.4 million as of March 31, 2022. Cash used in operating activities for the second quarter of 2022 totaled $4.4 million, an increase from $3.4 million in the first quarter of 2022 that primarily resulted from the clinical advancement of our product candidates. In July, we announced completion of a convertible notes financing for $8 million of gross proceeds received in the third quarter of 2022.
Federal Grants – Funding from federal grants was $0.2 million for the second quarter of 2022 compared to $0.4 in the comparable year ago quarter. Funding decreased by $0.2 million under the OUD Grant due to the timing of research activities eligible for funding. Funding under the MPAR grant in the second quarter was reduced because the annual funding limit through June 30, 2022, was reached. A fourth year of funding of the MPAR program was recently approved for $2.8 million covering the annual period through June 30, 2023.
Research & Development Expenses – R&D expenses were $5.3 million for the second quarter of 2022 compared to $0.5 million in the comparable year ago quarter. The increase was primarily the result of increased external research and development costs related to preclinical and clinical programs for PF614 and PF614-MPAR.
General & Administrative Expenses – G&A expenses were $2.0 million for the second quarter of 2022 compared to $0.4 million for the same period in 2021. The increase was primarily a result of increased expenses related to operating as a public company, including legal and accounting fees, fees incurred in connection with our recent financing, and director and officer insurance expenses.
Other Income (Expense) – Total other income (expense) was expense of $0.9 million in the second quarter of 2022 and expense of $0.5 million in the second quarter of 2021. The expense in the 2022 period is due to non-cash loss on debt conversions into common stock. The 2021 expense primarily reflects non-cash interest expense on notes that were converted on June 30, 2021.
Net Income (Loss) – Net loss for the second quarter of 2022 was $7.9 million compared to net loss of $1.0 million for the comparable year ago period. As a clinical stage biotech company, our continued research and development efforts toward regulatory approvals for our product candidates are expected to result in losses for the foreseeable future.
Additional Company Highlights

On July 1, 2022, the Company closed on $4.0 million of an $8.0 million convertible note financing, the remaining $4.0 million closed on August 9, 2022.
On July 13, 2022, the Company announced initial patients dosed in the first Human Abuse Potential study, PF614-103.
Corporate Update Conference Call

CEO, Dr. Lynn Kirkpatrick, CFO, Dave Humphrey, and CMO, Dr. Nily Osman will host a corporate update conference call on Wednesday, August 17, 2022, at 11:00am ET to provide a corporate update and review the recently discussed results and data from Clinical Trials PF614-102 and PF614-MPAR-101. The call will conclude with Q&A from participants. An accompanying presentation will be posted prior to the call to the Company’s investor relations website.

Please dial in at least 10 minutes before the start of the call to ensure timely participation. A playback of the call will be available through Wednesday, September 14, 2022. To listen, call 1-844-512-2921 within the United States and Canada or 1-412-317-6671 when calling internationally. Please use the replay pin number 13731880.