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Ensysce Biosciences (NASDAQ:ENSC) released full-year 2021 earnings recently and, as with almost all clinical stage pharmaceutical companies, the company reported a loss—in this case it amounted to a loss of $1.48 per share for the full year. But at this stage of development, we are much more interested in the ability to continue advancing trials to gain approval for the exciting treatments we describe below. And on that front, we were very encouraged. Cash and cash equivalents were $12.3 million as of December 31, 2021, as compared to $0.2 million for the same period in 2020. We are pleased with the improvement and management believes this funding should be sufficient for at least 2022's plan trials.
Ensysce Biosciences is committed to finding a solution to the opioid crisis plaguing the US and other developed countries around the world. Through its proprietary TAAP technology Ensysce is in the process of receiving approval for an abuse-resistant yet still pain-relieving opioid. The technology under the TAAP platform is designed to release effective opioid drugs only when exposed to specific physiological conditions—in this case specifically when the drug is ingested and exposed to the digestive enzyme trypsin. The company's proprietary technology prevents abuse through a two-step internal trypsin-activation process. The prodrugs are chemically stable molecules that are activated only when administered orally. Due to the activating enzyme of trypsin not being present in blood or saliva, the drug cannot be activated through injection, chewing or snorting. This is in contrast to many other opioid products marketed having, or in late-stage clinical development for, "abuse-resistance". These products often use extended-release formulations, which are still prone to abuse by crushing, chewing or extracting and injecting the drug for an immediate release of active opioid to achieve a rapid euphoric rush.
PF614 is the company's lead abuse resistant drug program. Ensysce has prioritized this program due to the crisis of oxycodone and the urgency to find a more abuse-resistant form of therapy. It is a chemically modified, extended-release oxycodone-derivative which releases clinically effective oxycodone only when exposed to trypsin, which is enzyme found in the digestion system. Importantly, the abuse-resistance provided by PF614 is designed to be unaffected by simple physical manipulation such as extraction, chewing or crushing.
MPAR (Multi-Pill Abuse Resistant) is a proprietary technology developed by Ensysce that protects patients from overdosing. It provides a trypsin inhibitor that limits the activation with increasing ingestion of the product. A small amount of MPAR is added to each TAAP product and does not affect the opioid release if taken as prescribed. Conversely, if the prescription is not followed, either intentionally or accidentally, MPAR provides protection through a trypsin inhibitor that block the activation and release of the opioid. Encysce has initiated a Phase I study of PF614-MPAR to assess the pharmacokinetics of oxycodone when PF614 is administered alone and with MPAR.
It is our opinion that the funding situation at Ensysce is good and will get better. If the PF614 drug continues to proceed through the trial process successfully, as we expect it to, we believe the interest in the company will grow and the funding opportunities will greatly increase. An additional aspect of the Ensysce business that we believe could make it more attractive to investors as PF614 gains traction is the explosion by financers interest in so-called ESG (environmental, social and governance) investing. With no hard guidelines available to define what exactly can fit into the ESG category, providing crucial pain relief equivalent to OxyContin without having the ability to make that drug into an addictive substance that has caused hundreds of thousands of deaths seems to us that it would fit will within an ESG-designated portfolio.
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