Ensysce Biosciences, Inc. is a clinical-stage biotechnology firm that uses its proprietary technology to produce safer prescription drugs. The company is currently developing a new type of tamper-proof opioids that control overdoses and drug abuse.
On 30th November 2021, ENSC reported the completion of safety review and enrollment of the last cohort of subjects in its study of Trypsin Activated Abuse Protected Opioid. The PF614-102 is a randomized, phase 1b, single-center clinical study. The study evaluates the bioavailability of single oral doses of PF614 and the safety of multiple-ascending oral doses of PF614 relative to OxyContin.
Mr. Matthew Johnston, PRA Health Sciences, is directing the study. After receiving a favorable safety review from the Safety Review Committee, the company has advanced the trial to a higher dose level. ENSC anticipates entering the bioequivalence stage of the study by January 2022. The data from the MAD study has expected to release by the first quarter of 2022.
ENSC Third Quarter 2021 Financial Results –
On 15th November 2021, ENSC published its financial results for the third quarter of 2021. The company has also presented its current business updates.
As of 30th September 2021, ENSC has $6.8 million in cash and cash equivalents. Net loss was $17.2 million for three months ended 30th September 2021. For the third quarter of 2020, ENSC has $1.6 million in net income. Research and development costs totaled $1.7 million for the third quarter ended 30th September 2021. For the same three months of 2020, research and development expenses were $0.9 million. The company reported general and administrative costs of $16.4 million for the third quarter of 2021. General and administrative expenses were $0.3 million for the previous year’s third quarter.
Chief executive officer of ENSC, Dr. Lynn Kirkpatrick, remarked that they had successfully achieved convertible note financing of $15M during the third quarter. It has provided them with the required proceeds to advance their leading clinical trials. They have already started the second study of TAAP opioids in September 2021, he added.
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