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Ensysce Biosciences, Inc. (ENSC) shows decline in premarket – Here’s why?

Ensysce Biosciences, Inc. (ENSC) experiences a decrease of 10.55% in the premarket. However, the last trading session closed at $4.55 with an increase of 48.21%.

Treatment of First Cohort for Subjects in Clinical Study of its Next Generation Opioid, PF614

ENSC announced on 8th September 2021 that they have started the treatment of the first cohort of Study to Evaluate the Pharmacokinetics and Safety of Multiple-Ascending Oral Doses of PF614. PF614 is a trypsin-activated abuse prevention extended-release oxycodone prodrug (TAAP).

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Moreover, the TAAP chemical alteration inactivates the active component in Ensysce’s opioids products, including PF614. It also provides abuse-deterrent, resistance to manipulation, and other types of recreational drug misuse, as well as a high level of pain treatment for people in severe pain. This trial will build on the first Phase 1 study’s findings in terms of safety and pharmacokinetics, and it might lead to a better understanding of how PF614 compares to commercially available products.

Second Quarter 2021 Financial Results

ENSC reported second-quarter 2021 financial results on 16th August 2021. Firstly, as of June 30, 2021, cash and cash equivalents totaled $8.0 million. Ensysce now has access to a $60 million share subscription facility that it entered into in December 2020. As a result, Ensysce thinks it has enough cash on hand to finance its present activities for at least the next twelve months.

Secondly, in the second quarter of 2021, federal grant funding was $0.4 million. The reduction is due to the timing of funding-eligible research activity. In the second quarter of 2021, research and development expenses were $0.5 million. The decrease was largely due to lower external research and development expenditures associated with PF614-MPARTM preclinical studies.

Thirdly, in the second quarter of 2021, general and administrative expenses were $0.4 million. Higher legal and other professional services expenditures linked to post-merger corporate matters accounted for the majority of the increase.

Notice of Allowance from the U.S. Patent and Trademark Office by ENSC

ENSC announced on 5th August 2021 that a patent has been awarded Notice of Allowance by the United States Patent and Trademark Office. The invention provides a technique for controlling the delivery of amphetamine to a patient. Lastly, these amphetamine prodrugs can be with a GI enzyme inhibitor which provides overdose protection for this family of drugs.

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