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Ensysce Biosciences CEO says mindful of potential shareholder dilution
The Fly

Ensysce Biosciences CEO says mindful of potential shareholder dilution

Ensysce Biosciences issued a letter to shareholders from CEO Lynn Kirkpatrick, to address the Company’s most recent frequently asked questions. The letter read in part, "What is the next Company milestone? As noted above in 2022 Ensysce initiated four clinical studies: PF614-102 for bioequivalence. PF614-103 evaluating nasal abuse potential. PF614-104 evaluating oral abuse potential. PF614-MPAR-101 evaluating our overdose protection platform, MPAR. We have reported positive results on three of these studies, and we are currently awaiting data from our oral abuse potential study, PF614-104, at the end of March. What does the Ensysce pipeline look like? Our lead product, PF614 is an oxycodone product for severe pain to go head-to-head with the current ADF products on the market. Our MPAR combination products provide overdose protection to our TAAP portfolio. PF614-MPAR will follow the launch of PF614. These two products offer improved oral delivery of oxycodone, reduced abuse potential and, ultimately, overdose protection. We believe we can use our TAAP platform to improve other prescription drugs and have a number of other clinical candidates identified to be rolled out as we progress. We are exploring these opportunities….As of September 30, 2022, we reported $4.5 million in cash on hand and $5.8 million of remaining federal government grant support. Recent financing transactions include a $4.1 million public offering in December 2022 and a $3.0 million registered direct offering in February 2023. We will be reporting our updated cash position as of December 31, 2022, with our Form 10-K filing in March 2023. Why has the share price not responded as planned? While we do not believe it is appropriate to speculate as to why the share price performance is not stronger, despite our continued execution against our developmental plans, we want to express our disappointment. We cannot control the stock market and therefore are focused on the variables of our business that we can control. As a result, we hope that our continued diligence and execution translates to value that is ultimately reflected in our share price. We remain committed to our mission, to helping people in pain, and to our shareholders. Should we be worried about further dilution or the Company’s cash position? Ensysce is a pre-revenue, clinical stage biotech company. As we advance our clinical development toward commercialization, our cash burn is expected to increase. We believe we have made exceptional strides to advance our programs with limited financial resources. We are mindful of market conditions and have been thoughtful with our sources for funding, including the use of non-dilutive financing through grants from the federal government. Committed long-term shareholders are our most important constituent right now. Hence, we are constantly looking for the best opportunity for capital, while being mindful of potential shareholder dilution."

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