Ensysce Biosciences, Inc.

Good morning and welcome to the Incise Biosciences Incorporated corporate update call. As a reminder, this conference is being recorded. Your hosts today are Dr. Lynn Kirkpatrick, Chief Executive Officer, Dr. Bill Schmidt, 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. We 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 10-Q and 10-K for more complete discussion of these factors and other risks, particularly under the heading Risk Factors. At this time, I'd like to turn the call over to Chief Executive Officer, Dr. Lynn Kirkpatrick. Lynn?

Thank you, Operator, and good morning, everyone. Thank you for joining us. I am pleased to welcome you to today's Corporate Update Conference Call. Although some of you are familiar with NCISE, I've historically kicked off these calls spending a few minutes reviewing our technology platforms and overall company focus for those of you new to our story. First, we are a clinical stage biotech company using sophisticated chemistry to improve drug safety and performance. Our technology platforms 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 both powerful and safe. Our first effort is to bring to market the next generation analgesics for strong pain relief. I will review our two technology platforms to offer background before we review recent clinical trial results. TAP stands for Trypsin Activated Abuse Protection. TAP is simply a chemical modification that makes a drug inactive until it is swallowed and reaches the small intestine where it's exposed to an enzyme called trypsin. Trypsin is only found in the small intestine where it is responsible for digesting the proteins and meats we eat. This exposure to trypsin allows our own body to turn on our TAP drugs by starting the release process. TAP allows us to deliver medicines orally, and we refer to it as sophisticated chemistry since we can use the chemical modification to fine-tune how quickly or slowly a drug is released. TAP can be applied to most types of medicines to either make them safer or actually perform better. We have applied TAP to opioid products in an attempt to reduce recreational drug abuse. Our second technology platform, MPAR, stands for Multi-Pill Abuse Resistance. MPAR is a smart overdose protection technology designed to be combined with our TAP program, ProDrugs, to prevent patients or abusers from overdosing. TAP turns off the release of the active ingredient in an overdose situation. This protection from oral overdose is designed to activate only when more than the prescribed dose is taken. As mentioned, we have applied these transformative technologies initially to opioid products. to produce the next generation analgesics to treat severe pain. Now I stress severe pain, which is what an opioid is indicated for. There are many types of pains where opioids are not appropriate and not the focus of our current programs. As an example, there are those individuals who may require an opioid to control pain on a limited basis after major surgery, such as hip or knee replacement. whereby controlling pain in these situations appropriately may prevent one from developing chronic pain and needing opioids long-term. The CDC has just released guidelines for the clinical practice of prescribing opioids, recognizing the need for these medications for severe pain when other therapies are contraindicated or likely to be ineffective. We do know that in circumstances such as severe traumatic injuries or invasive surgeries, having pain is inevitable, but we feel suffering from severe pain should be optional, and that is the role for PF614. We also know past opioid use has led to a crisis, yet our TAP and MPAR technologies have been developed to address and reduce both abuse, and overdose of these prescription pain products, something that other marketed abuse deterrent formulations of opioids have failed to achieve. It is important to note that although we are focused on developing our lead product, PF614, both our TAP and MPAR technologies can be applied to many more prescription drugs, therefore providing us with ongoing opportunities As our pipeline shows, we have applied tap chemical modification to a number of opioids, as well as drugs to treat ADHD. And we have a discovery program focused on novel tap agents for treatment of opioid use disorder. Our main focus today is to update you on our lead program, PF614, an oxycodone tap product.

which is designed to replace OxyContin in the marketplace.