By Brad Sorensen, CFA



By Brad Sorensen, CFA



Ensysce Bioscience (NASDAQ:ENSC) is a California-based, clinical stage pharmaceutical company whose research centers on finding solutions to the many problems associated with opioids, while keeping in place the positive aspects. For all the negative press that opioids have received, and rightly so in many cases, they do play an important role in the relief of severe pain. Ensysce’s goal is to preserve that pain relief ability that is so vital and create a drug that severely reduces the potential for addiction, misuse and overdose—and, as a result, also reduce the fear among those in pain of suffering some or all of those negative consequences.

The Problem

The heart of almost any good business idea is solving a problem that people have, whether they know it or not. And there is no doubt that opioid abuse is serious problem affecting thousands of Americans every year. And it’s not just in America—the World Health Organization estimates that there are approximately 500,000 deaths worldwide attributable to drug use—and 70% of those are related to opioids. Recent history shows that deaths related to opioids around the developed world are rising:

Back in the US, according to

– Opioids are a factor in 7 out of 10 overdose deaths.

– Drug overdose deaths are up 30% year-over-year (y/y)—as of March 2021

– More than four times as many people died from drug overdose than homicide in the first month of 2021

– Opioids kill more than 136 Americans every day

– The national OD death rate increased 255.74% between 2000 and 2019

With all of these problems associated with opioids, why do they continue to be used at a rate of over 142,000,000 opioid prescriptions dispensed in 2020 according to the Center for Disease Control (CDC)? The short answer is—because it works. Opioids is a broad term referring to a class of drug that is naturally found in the opium poppy plant but can also be produced in a lab using the same chemical structure. Opioids are used in drugs because they contain chemicals that relax the body and relieve pain. Prescription opioids are used to treat moderate to severe pain and some can be used to treat symptoms such as coughing. And the need for pain relief is extensive with the CDC reporting that in 2019 20.4% of adult Americans had chronic pain, while 7.4% of adults had chronic pain that frequently limited life or work activities. But as we’ve seen, the relief that opioids can provide can lead to abuse. Opioids are highly addictive due in large part to the activation of reward centers in the brain. Neurotransmitters are triggered to release endorphins. Endorphins dull the pain perception and gives feelings of pleasure. When the dose wears off—people find themselves wanting those feeling back. When a body takes opioids over time the body slows its production of endorphins so the same dose stops producing the strong good feelings. This can lead to people upping the number of opioids they are taking.1

Opioids given as a prescription in pill form can then be crushed or ground up—turning it into a fine powder that can be snorted or injected—speeding up the effects on the central nervous system. Opioids such as Oxycodone can come in extended-release formulas, such as Oxycontin, that are intended to slowly release the drug throughout the day—crushing and snorting these pills leaves that extended-release mechanism obsolete and the effects are experienced immediately.

Once people get addicted, quitting is not only extremely difficult but can also be extremely dangerous, with death sometimes being the outcome of trying to quit “cold turkey”. Withdrawal symptoms can include anxiety and insomnia, to fever and shaking, to high blood pressure, hallucinations and seizures.

As with every recent administration, the Biden White House recognizes the problem of overdose and the havoc it is causing in so many lives and recently rolled out a new strategy it is hoping will slow the rise in drug overdose deaths, which comes with an $11.2 billion request from Congress.

An additional problem is that, given the risks of addiction and the dire potential consequences described above, people that are suffering from life-altering severe pain are fearful to use opioid-based drugs and fail to receive the relief from the pain that would vastly improve their lives.

The Solution

It’s hard to imagine having a larger impact on society from a drug than if one could be produced that provided the pain relief from opioids, but without the ability to abuse and become addicted to them. That’s the noble goal of Ensysce Biosciences.

The company currently has platforms that utilize a novel molecular technology designed to deter prescription opioid abuse at a molecular level. Their current pipeline includes one line that addresses the opioid issue and they have another line that resulted from their research that addresses COVID-19 and some pulmonary diseases. The core of what Ensysce is doing involves two platforms:

1. An abuse resistant opioid prodrug technology—the Trypsin Activated Abuse Protection, or the TAAP platform

2. An over-dose protection opioid prodrug technology—the Multi-Pill Abuse Resistant, or the MPAR platform.

While Ensysce was researching what would work to combat the opioid problem, the scientists realized that one of the ingredients in their MPAR technology, known as nafamostat, could also be used in combatting COVID-19 and other pulmonary diseases such as cystic fibrosis.

With Ensysce making what we view as very good progress toward a commercial version of a much-needed drug that is much less addictive and could solve a couple of major problems, we think ENSC is worth a look. It’s certainly on the risky end of the scale and they have no sales as of yet and that could continue for the foreseeable future—but the potential upside with approval of the companies’ drug makes it a potential attractive position to take for those with a higher risk tolerance.

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1. Mayo Clinic —