Shift-4
7 days ago
The implications of this stock are ridiculous fundamentally speaking, but what has me intrigued is the expiration of the financing restrictions established by GEM Bahamas as a condition of Ensysce's RM with (formerly) LACQ.
The three-year terms of the financing restrictions were established in late December of 2020, but their effective date was July, 2021. It established a revolving line-of-credit with GEM, whereby the company could access up to $60M of capital by issuing shares at 90% of a preceding interval price to GEM Bahamas. This gives GEM a vested interest in shorting the stock relentlessly to ensure that any conversion would result in maximum share allocation (to them) and maximum dilution (to shareholders). The embedded restrictions severely hampered ENSC's ability to secure alternative financing.
The company has run a razor-lean operation to avoid tapping this line of credit, and has been unable to consider other financing offers while the contract is in effect. GEM has rather obviously been running a ruthless naked shorting operation to ensure that any redemption earns them maximum future profit. The July expiration of this arrangement means no more need for either, and I expected the market rebound to begin in anticipation of this. It appears to have begun; I believe it will continue. And I think the company is going to have a lot to reveal to shareholders about what they've been arranging for when the financial handcuffs come off.
There are a large number of significant developments this company could announce which would positively impact the share price. But this key issue is, I believe, the explanation for both the historic devaluation of the stock to truly absurd levels, and also why no previous runs have been sustainable. Its ending marks a new beginning for ENSC, and in my opinion an historic run when the market re-adjusts.
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subslover
1 year ago
nsysce Biosciences Announces Successful Completion of Ground-Breaking Study on Overdose Protection
~ Represents Major Milestone Towards Launch of PF614-MPAR ~
~ PF614-MPAR on Track to be the First Drug to Protect Against Overdose ~
SAN DIEGO, CA / ACCESSWIRE / May 9, 2023 / Ensysce Biosciences, Inc. (NASDAQ:ENSC), clinical-stage biotech company applying transformative chemistry to improve prescription drug safety, today announced completion of PF614-MPAR-101, a clinical study examining the Company's first pain medication with overdose protection, PF614-MPAR. The final Part B of the study examined dose escalation of PF614-MPAR from 25 to 200 mg (1 to 8 dose units) and showed that PF614-MPAR successfully reduced opioid delivery when three or more doses are consumed simultaneously.
We believe PF614-MPAR is the first drug which can limit opioid exposure when too many pills are swallowed, protecting against overdose. In our PF614-MPAR-101 study, the data showed that a 25 mg dose of PF614-MPAR, delivered oxycodone as designed for what may be a prescribed dose of one to two capsules. Importantly, when administering three or more capsules simultaneously, the amount of opioid released and absorbed into the circulation diminished as compared to the unprotected PF614, thereby substantially reducing the risk of overdose.
Opioids are used widely for the treatment of severe pain, for example, in patients fighting cancer and for post-operative pain. Opioids are highly effective but carry a significant risk of abuse, addiction and overdose. Overdoses with opioids continue to be a major issue which may occur due to inadvertent over-use, or purposefully when family members find drugs to experiment with in the medicine cabinet.
According to Dr. William Schmidt, Chief Medical Officer of Ensysce Biosciences, "This first-in-human demonstration of MPAR's unique ability to reduce the adverse consequences of excessive opioid consumption is a major step towards Ensysce's goal of making safer prescription drugs. If approved by the FDA, PF614-MPAR could represent a true game-changer for the treatment of severe pain, and could validate our MPARβ’ technology for application to a range of other medications."
"This successful outcome brings us closer to the launch of the first opioid with overdose protection," said Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce Biosciences. "PF614-MPAR is potentially a first-in-class agent designed to treat severe pain while not only reducing the ability to abuse for recreational purposes but also to provide protection from overdose. The results showed that our patented technology MPARβ’, which βswitches off' the active drug release, can limit delivery when excess was consumed. Our next step is to clearly define the drug product for all planned dose strengths to optimize effects across our planned dose range. The PF614-MPAR-101 study is particularly important as a proof-of-concept for the base MPARβ’ technology which we believe could be used to control delivery of many other drug classes where there may be a narrow therapeutic range. We are excited to explore this further with other therapies as it may help to save many lives in the future."
About Ensysce Biosciences
Ensysce Biosciences is a clinical-stage biotech company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin Activated Abuse Protection (TAAP) and Multi-Pill Abuse Resistance (MPARβ’) platforms, the Company is in the process of developing a unique, tamper-resistant treatment option for pain that minimizes the risk of both opioid drug abuse and accidental or intentional overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. For more information, please visit www.ensysce.com.
Forward-Looking Statements
Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as "may," "intends," "can," "might," "will," "expect," "plan," "possible," "believe" and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter