Dear Fellow Shareholders
I am very pleased to provide you with an update on the outstanding progress we made over the last year and to extend sincere thanks from the Ensysce team for your ongoing support. During 2023, our focus was to demonstrate that our innovative approaches to severe pain could be delivered safely and effectively, and with the unique benefit of overdose protection. I believe we achieved that, and we are continuing to move our lead analgesic through to commercialization, as we also add to our pipeline of products to treat pain.
I will recap the milestones achieved over the last 12 months and discuss next steps as we gear up for what we hope to be a transformational year in 2024.
One objective for 2023 was to increase the awareness of health care professionals and the public about what we describe as our 'Next Generation' analgesics. We highlighted the data we generated from our technology platforms, TAAP and MPAR, by presenting along with key experts at industry events and scientific venues. Our leadership team hosted seminars, presented clinical data, and served as featured speakers at major therapeutic and business events. As we made strong progress with the development of our programs, we presented the results throughout the year at the following events: The annual PAINWeek scientific meeting
The 4th Annual NIH 'Helping End Addiction Long-Term' (HEAL) Meeting
Drug,
The Fierce New Product Planning Summit 2023
The 17th Annual Pain Therapeutics Summit
The highlight event of the year was the Ensysce hosted Symposium for a global community of leading pain professionals during PAINWeek 2023 in September. Along with industry experts, we provided a review of the current landscape for severe pain treatment, reviewed drug use and abuse in America and then examined the safety and effectiveness of PF614 and PF614-MPAR, our two leading 'next generation' analgesics.
It was gratifying that after all of our presentations, we received very positive feedback from world renowned experts in pain to our clinical trial data and the underlying science of our products.
Our development progress with PF614, a TAAPTM extended-release oxycodone to treat severe pain, involved completion of a number of clinical trials and non-clinical studies required for approval, as well as the completion of key manufacturing activities. This work has culminated in a body of data that has been compiled into the regulatory submission for our End of Phase 2 discussions with the FDA, scheduled for
Additional clinical data was announced in April, when we reported positive results from PF614-104, a study that evaluated the oral abuse potential of PF614. The study met key endpoints and showed that oral administration of PF614 had significantly lower scores for 'Overall Drug Liking' and willingness to 'Take Drug Again' than the oxycodone comparator.
Mid-year we also quickly began planning our first study to measure the onset of pain-relief for PF614, a key study suggested by FDA, to ensure it was completed in time for our meeting with the FDA. The timeline was short, but we received
To ensure the market readiness of our lead drug candidate PF614, we also secured partnerships and worked with Commercial Manufacturing Organizations to prepare drug substance and drug product, a key step in ensuring commercial supply capabilities.
In parallel to advancing PF614, we also continued to make clinical progress with the first opioid product with overall overdose protection, PF614-MPAR. MPAR reduces or 'turns off' the release of the opioid from our TAAP prodrugs to prevent overdose. We believe this is the only technology that may reduce prescription drug overdoses stemming from oral abuse, ultimately saving lives. Currently marketed abuse deterrent technologies do not effectively deter one of the most common and dangerous forms of opioid abuse - swallowing an increased number of tablets than are prescribed. The
The clinical overdose-protection data generated for PF614-MPAR was reported in
We believe the clinical results described above are evidence that PF614 and PF614-MPAR analgesics will disrupt the opioid pain market. These 'next generation' analgesics have proven they are equally safe and effective as current prescription opioids. This is important as opioids remain a vital element in the treatment of severe conditions such as post-operative and cancer pain.
In addition to our clinical progress, we continue to build our efforts in commercialization as we engaged a firm with extensive Business Development expertise,
Another option to strengthen our commercial offerings arose with our new relationship with the Swedish company,
Operationally and financially, we took several important steps allowing us to advance the clinical development of our highly unique programs. During 2023, we completed three financing transactions for total gross proceeds of
As we enter 2024, we are focused on our near-term discussions with the FDA on our Phase 3 protocol design for PF614. Our End of Phase 2 discussions are scheduled with the FDA on
The accomplishments we've achieved in 2023, and our tangible forward goals, are a result of the hard work and commitment of our entire team. We are passionate about our mission to deliver new and improved forms of analgesia both in the
We are entering 2024 with real excitement for what we believe will be a pivotal year for Ensysce. We thank you, our shareholders, for your support and we thank our employees for fueling the direction of our clinical, operational, and financial execution. We look forward to sharing our accomplishments in the coming year as we strive to create value for our shareholders, employees, and communities, and we thank all of you for your dedication to our mission.
Sincerely, Dr.
Chief Executive Officer
About
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 problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking statements are based on estimates and assumptions by Ensysce's management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected. In addition, Ensysce's business is subject to additional risks and uncertainties, including among others, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce's product candidates; the availability or commercial potential of product candidates; the ability of Ensysce to fund its continued operations, including its planned clinical trials; the dilutive effect of stock issuances from our fundraising and Ensysce's and its partners' ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of material risks and uncertainties that are described in Ensysce's most recent quarterly report on Form 10-Q and current reports on Form 8-K, which are available, free of charge, at the
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