Ensysce Biosciences, Inc.

Good morning and welcome to the NCISE Biosciences, Inc. Corporate Update Call. As a reminder, this conference is being recorded. Your hosts today are Dr. Lynn Kirkpatrick, Chief Executive Officer, Dr. Nylee Osman, Chief Medical Officer, and Dave Humphrey, Chief Financial Officer. Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include predictions, estimates, or other information that might be considered forward-looking. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation. Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events. Throughout today's discussion, we will attempt to present some important factors relating to our business that may affect our predictions. You should also review our most recent forms, 10Q and 10K, for a more complete discussion of these factors and other risks, particularly under the heading Risk Factors. At this time, I would like to turn the call over to our Chief Executive Officer, Dr. Lynn Kirkpatrick. Lynn, you may begin.

Thank you, Operator, and good morning, everyone. Thank you for joining us. I am pleased to welcome you to our Corporate Update Conference Call. Before I begin, I want to direct your attention to the slide deck posted and accessible on our Investor Relations website at irncise.com. This slide deck is our latest investor presentation, inclusive of the recently released clinical data from the PF614-102 and PF614 MPAR 101 studies, which we're very eager to review with you in detail this morning. Additionally, we posted our second quarter financial results and filed our 10-2, both of which are also available on our website. Now, some of you are familiar with NCIS, but as I have historically kicked off these calls, I would like to spend just a few minutes reviewing our technical platforms and overall company for those of you new to our event. First, we are a clinical stage biotech company using sophisticated chemistry to improve drug safety and performance. Our technologies, TAP and MPAR, are designed to improve delivery and reduce abuse and overdose of prescription drugs with a goal of creating new classes of prescription medicines that are intended to be powerful and safe. Our focus is to initially utilize our transformative technologies to address the ongoing opioid crisis. We have applied our chemical approach to a number of opioid therapies, and our lead program is an oxycodone product to replace OxyContin in the marketplace. Our lead agent, PF614, has received fast-track status from the FDA, and we have pursued bioequivalence data for PF614. Importantly, we believe... Bioequivalence provides a shortened path to registration through the 505 regulatory process. For those of unfamiliar, bioequivalence is the comparison of two dosage forms or active ingredients showing that they provide similar blood concentration levels, therefore resulting in the same therapeutic effect. Our technologies have over 100 patents issued in 25 countries, are supported by over $100 million in investment since our inception, and we have been advancing our lead products through clinical development and exploring other means of applying our technologies, including for ADHD and opioid use disorder indications. Additionally, we've built a strong team to assist in our clinical and development progress. Before I turn the call over to Dr. Osman to run through our recently reported clinical data, I want to review our two technology platforms in detail. This will be helpful background as we review the clinical trial results. For those following along in the slide deck, I would like to turn your attention to slide five. The first technology, TAP, stands for Trypsin-Activated Abuse Protection. TAP is a chemical modification creating what is called a prodrug that inactivates the drug in NCISIS products until they reach the small intestine, including our lead agent, PF614. Trypsin is a digestive enzyme that is only active in the small intestine. trypsin activates or turns on the release of the active ingredient in our drug products. Therefore, we believe our chemical modification protects from types of abuse such as snorting or injecting, provides resistance to manipulation of our products, commonly called kitchen chemistry, and is meant to reduce other forms of recreational drug abuse. Our second technology platform, MPAR, stands for Multi-Pill Abuse Resistance. MPAR is a smart overdose protection designed to be combined with our top pro drugs to prevent patients or abusers from overdosing. MPAR turns off the release of the active ingredients in an overdose situation. This protection from oral overdose is designed to activate only when more than the prescribed dose is taken. Importantly, we believe that applying our technologies to opioids does not limit the ability of our products to provide a high degree of pain relief for those in severe pain. Now for the primary purpose of our call today. While later we will touch on financial results from the week's earnings release, I now turn the call over to Nylee to allow her to take this opportunity to review the recently reported data from our PF614-102 clinical study. Dr. Osman is our chief medical officer. She is a highly versatile board-certified neurologist, migraine and pain specialist with over 10 years of experience in both R&D and medical affairs, within the pharmaceutical, CRO, and medical device industries. Nylee, the floor is yours.

Thank you, Lynn.