Ensysce Biosciences Issues Annual Shareholder Letter
Ensysce Biosciences (NASDAQ:ENSC) reported significant progress in 2024 for its innovative pain relief solutions. Key achievements include receiving FDA Breakthrough Therapy designation for PF614-MPAR, an opioid with overdose protection, and advancing their lead product PF614, a tamper-resistant extended-release oxycodone.
The company completed an End of Phase 2 FDA meeting for PF614 and plans to commence Phase 3 trials in Q2 2025. They also initiated a Phase 1b study for PF614-MPAR and selected PF9001 as their lead candidate for Opioid Use Disorder treatment.
Financial highlights include securing $4.7 million through a warrant inducement in February, $5 million in August, and receiving a $14 million NIH grant for PF614-MPAR development. The company aims to submit a New Drug Application for PF614 in 2026.
Ensysce Biosciences (NASDAQ:ENSC) ha riportato progressi significativi nel 2024 per le sue innovative soluzioni di sollievo dal dolore. I risultati chiave includono l'assegnazione della designazione di Terapia Innovativa da parte della FDA per PF614-MPAR, un oppioide con protezione da sovradosaggio, e l'avanzamento del loro prodotto principale PF614, un ossicodone a rilascio prolungato resistente alla manomissione.
La società ha completato un incontro di Fine Fase 2 con la FDA per PF614 e prevede di avviare gli studi di Fase 3 nel secondo trimestre del 2025. Inoltre, hanno avviato uno studio di Fase 1b per PF614-MPAR e hanno selezionato PF9001 come candidato principale per il trattamento del Disturbo da Uso di Oppioidi.
I punti salienti finanziari includono il reperimento di 4,7 milioni di dollari attraverso un incentivo di warrant a febbraio, 5 milioni ad agosto, e il ricevimento di una sovvenzione NIH di 14 milioni di dollari per lo sviluppo di PF614-MPAR. L'azienda prevede di presentare una Nuova Domanda di Autorizzazione per PF614 nel 2026.
Ensysce Biosciences (NASDAQ:ENSC) informó de avances significativos en 2024 para sus innovadoras soluciones para el alivio del dolor. Los logros clave incluyen la obtención de la designación de Terapia Innovadora de la FDA para PF614-MPAR, un opioide con protección contra sobredosis, y el avance de su producto principal PF614, un oxicodona de liberación prolongada resistente a manipulaciones.
La compañía completó una reunión de Fin de Fase 2 con la FDA para PF614 y planea comenzar ensayos de Fase 3 en el segundo trimestre de 2025. También iniciaron un estudio de Fase 1b para PF614-MPAR y seleccionaron PF9001 como su candidato principal para el tratamiento del Trastorno por Uso de Opioides.
Los aspectos financieros destacados incluyen asegurar 4.7 millones de dólares a través de un incentivo de warrants en febrero, 5 millones en agosto, y recibir una subvención de 14 millones de dólares del NIH para el desarrollo de PF614-MPAR. La compañía aspira a presentar una Nueva Solicitud de Medicamento para PF614 en 2026.
Ensysce Biosciences (NASDAQ:ENSC)는 2024년 혁신적인 통증 완화 솔루션에서 중요한 진전을 보고했습니다. 주요 성과로는 과다복용 보호가 있는 오피오이드 PF614-MPAR에 대한 FDA의 혁신 치료제 지정 획득과 변조 방지형 지속 방출 옥시코돈 PF614의 진전을 포함합니다.
회사는 PF614에 대한 FDA 2상 종료 회의를 완료했으며, 2025년 2분기에 3상 임상을 시작할 계획입니다. 또한 PF614-MPAR에 대한 1b상 연구를 시작하고, 오피오이드 사용 장애 치료를 위한 주요 후보로 PF9001을 선정했습니다.
재무 하이라이트로는 2월에 470만 달러, 8월에 500만 달러를 보장하고, PF614-MPAR 개발을 위한 NIH로부터 1400만 달러의 보조금을 받았다는 점이 있습니다. 회사는 2026년 PF614에 대한 신약 신청서를 제출할 계획입니다.
Ensysce Biosciences (NASDAQ:ENSC) a signalé des progrès significatifs en 2024 pour ses solutions innovantes de soulagement de la douleur. Les réalisations clés incluent l'obtention de la désignation de Thérapie Innovante par la FDA pour PF614-MPAR, un opioïde avec protection contre le surdosage, et l'avancement de leur produit phare PF614, un oxydodone à libération prolongée résistant à la manipulation.
L'entreprise a complété une réunion de Fin de Phase 2 avec la FDA pour PF614 et prévoit de commencer les essais de Phase 3 au deuxième trimestre de 2025. Ils ont également lancé une étude de Phase 1b pour PF614-MPAR et sélectionné PF9001 comme leur candidat principal pour le traitement du Trouble d'Usage des Opioïdes.
Les points forts financiers incluent l'obtention de 4,7 millions de dollars par le biais d'une incitation à warrants en février, 5 millions en août, et la réception d'une subvention de 14 millions de dollars du NIH pour le développement de PF614-MPAR. L'entreprise vise à soumettre une Demande de Nouveau Médicament pour PF614 en 2026.
Ensysce Biosciences (NASDAQ:ENSC) berichtet von bedeutenden Fortschritten im Jahr 2024 bei seinen innovativen Lösungen zur Schmerzlinderung. Zu den wichtigsten Erfolgen gehört die Zulassung als Durchbruchtherapie durch die FDA für PF614-MPAR, ein Opioid mit Überdosierungsschutz, sowie der Fortschritt ihres führenden Produkts PF614, ein manipulationsresistentes Oxycodon mit verlängerter Freisetzung.
Das Unternehmen hat ein Treffen zum Ende der Phase 2 mit der FDA für PF614 abgeschlossen und plant, im 2. Quartal 2025 mit Phase-3-Studien zu beginnen. Außerdem haben sie eine Phase-1b-Studie für PF614-MPAR initiiert und PF9001 als ihren Hauptkandidaten für die Behandlung der Opioidabhängigkeit ausgewählt.
Zu den finanziellen Höhepunkten gehört die Sicherung von 4,7 Millionen Dollar durch eine Warrants-Incentive im Februar, 5 Millionen im August, sowie der Erhalt eines NIH-Zuschusses in Höhe von 14 Millionen Dollar für die Entwicklung von PF614-MPAR. Das Unternehmen plant, 2026 einen Antrag auf Zulassung eines neuen Arzneimittels für PF614 einzureichen.
- Received FDA Breakthrough Therapy designation for PF614-MPAR
- Secured $23.7 million in total funding ($9.7M through financing and $14M NIH grant)
- Successfully completed FDA End of Phase 2 meeting for PF614
- Established bioequivalence between PF614 and OxyContin
- Formed strategic partnership with specialty drug manufacturer for commercial production
- Phase 3 trials not starting until Q2 2025
- New Drug Application timeline pushed to 2026
- Required additional financing through warrant inducement and funding transaction
Insights
The FDA Breakthrough Therapy designation for PF614-MPAR represents a significant regulatory milestone that could accelerate the development timeline. The designation, combined with the
The bioequivalence demonstration between PF614 and OxyContin enables a streamlined 505(b)(2) regulatory pathway, potentially reducing development costs and timelines. The TAAP and MPAR platforms address the critical need for abuse-deterrent opioids while maintaining efficacy, targeting a
The clinical development strategy shows thoughtful progression with multiple value-creating milestones ahead. The successful completion of the End-of-Phase 2 meeting and FDA alignment on Phase 3 design significantly reduces regulatory risk. The PF614-MPAR-102 study utilizing Quotient Sciences' Translational Pharmaceutics platform demonstrates efficient development planning.
The selection of PF9001 as the lead OUD candidate, with potentially improved cardiovascular safety over methadone, represents strategic expansion into an adjacent market. The established manufacturing partnerships with Purisys and a specialty manufacturer ensure scalability and commercial readiness.
With a market cap of just
The commercial opportunity is substantial given the unmet need for abuse-deterrent opioids. The 505(b)(2) pathway reduces development costs and time to market. Key catalysts in 2025 include Phase 3 initiation for PF614 and PF614-MPAR Phase 1b data, which could drive significant value creation.
~ FDA Breakthrough Therapy designation received for PF614-MPAR ~
~ PF614-MPAR second clinical trial initiated ~
~ Lead clinical candidate identified for OUD program ~
~ PF614 Phase 3 trial poised to commence 1H 2025 ~
SAN DIEGO, CA / ACCESSWIRE / January 8, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today issued a letter to shareholders from Chief Executive Officer, Dr. Lynn Kirkpatrick.
Dear Fellow Shareholders,
2024 was underscored by outstanding progress for our two clinical programs, and I would like to thank you and all of our committed shareholders for their support over the last year. We have achieved several key milestones in our efforts to develop our highly novel approach to providing opioid pain relief while reducing abuse and prescription drug overdose, an approach that we believe will save many lives. I welcome this opportunity to summarize last year's events and milestones achieved and to present a look ahead to what we believe will be another exceptional year in 2025.
Our focus in 2024 was to continue the advancement of our two clinical programs built around our TAAP™ and MPAR® platforms. Our lead product PF614, a Trypsin-Activated Abuse Protection (TAAPTM) extended-release oxycodone, will spearhead our "next generation" analgesic portfolio. The TAAPTM chemical modification is designed to control the rate of release of a known prescription drug and to be highly resistant to tampering for recreational use, thereby reducing abuse via non-oral routes of administration including snorting, chewing or injecting. Our second drug candidate PF614-MPAR, built on the platform of PF614, has added oral-overdose protection, and is a combination product of PF614 with a trypsin inhibitor. MPAR® (Multi-Pill Abuse Resistance) is designed to deliver powerful pain relief yet "switches off" the release of the opioid in an overdose situation, providing an additional layer of protection to Ensysce's TAAP™ medications. This represents an industry first and a major breakthrough for Ensysce that was recognized by the U.S. Food & Drug Administration (FDA) with Breakthrough Therapy designation in January 2024.
These two programs are positioned to be approved at a vital time, with the safety of opioids and limited access to pain medication being some of the most critical healthcare issues in the U.S. today. We believe our TAAP™ and MPAR® opioids can act as a solution by providing relief to the millions of people in the U.S. suffering from severe and chronic pain who are now struggling to gain access to drugs that provide them with an improved quality of life.
In 2024, we made significant progress toward our development milestones for PF614. Early in 2024, we completed a regulatory End of Phase 2 meeting with the FDA, an important discussion about our program which provided feedback and guidance on the design of our Phase 3 clinical program, ultimately reducing the regulatory risks for our commercialization plan.
We also announced the peer reviewed online publication of our manuscript reporting the results of our second clinical study of PF614 entitled, "Clinical evaluation of PF614, a novel TAAPTM prodrug of oxycodone, versus OxyContin® in a multi-ascending dose study with a bioequivalence arm in healthy volunteers" in Clinical and Translational Science (CTS), a journal of the American Society of Clinical Pharmacology and Therapeutics (ASCPT). The results from the two-part PF614‑102 study demonstrated a clear dose relationship between PF614 and oxycodone release. Importantly, the study established the bioequivalence between PF614 and OxyContin, which can potentially lead to using the streamlined 505(b)(2) path to registration.
Mid-year, we submitted the Phase 3 study protocol and statistical analysis plan for regulatory review by the FDA. This PF614-301 study, entitled "A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain after Abdominoplasty", intends to evaluate PF614 versus placebo for pain relief in subjects undergoing abdominoplasty surgery. Feedback on the Phase 3 design was received in December, and we are now reviewing Contract Research Organizations (CROs) to select an experienced team to work with to successfully execute this important study which we expect to start enrolling in the second quarter of 2025. We enter this Phase 3 study having support that PF614 delivers a known and effective analgesic and we look forward to being able to provide an update in our next annual letter.
Our MPAR program also continued to advance in 2024. The Breakthrough Therapy designation for PF614-MPAR, received in January, is provided to expedite the development and review of drugs that are intended to treat a serious condition where the drug may demonstrate substantial improvement over available therapies. This rare designation from the FDA speaks to the innovation of our MPAR® overdose protection platform. Additional regulatory guidance from the FDA was received in February for the PF614-MPAR non-clinical program, aiding its progression toward a new drug application (NDA) submission and accelerating its pace to market.
To progress the clinical development of PF614-MPAR, we renewed our collaboration with Quotient Sciences and received approval from the Investigational Review Board (IRB) to undertake the Phase 1b study, PF614-MPAR-102, "A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 when PF614 capsule is Co‑Administered with Nafamostat as a combination Immediate Release solution and Extended-Release Capsule Formulation in Healthy Subjects". This study will examine the full commercial dose range of the PF614-MPAR drug product to verify both overdose protection and effective delivery of oxycodone. The study is applying the Quotient Sciences Translational Pharmaceutics® platform to manufacture and test the PF614-MPAR drug product, expediting the clinical study process. Following receipt in September of a
2024 also saw a critical milestone achieved for our Opioid Use Disorder (OUD) program. Based on the data package that had been built over the last few years, we were able to select PF9001 as the lead drug candidate. PF9001 is designed using our TAAPTM and MPAR® technology to provide a safer treatment for the millions of Americans who are suffering from opioid overuse and addiction. A critical benefit of PF9001 is its lower potential for cardiovascular side effects compared with traditional methadone OUD treatments.
As we position our analgesic portfolio for commercial-scale production, we have established several strategic partnerships to strengthen our manufacturing capabilities. Today, PF614 drug substance is being produced for clinical trial use and will see commercial scale-up in 2025 through Purisys LLC. Most recently we initiated a strategic partnership with a leading specialty drug product manufacturer for the development and commercial launch of both PF614 and PF614-MPAR. This partnership will provide us with clinical trial material, drug products for regulatory submissions, and initial commercial batches of PF614 and PF614-MPAR. Additional services encompass the complete manufacturing process, including packaging, labeling, and shipment of the products, ensuring a seamless transition from regulatory approval to market entry.
To reinforce the innovative science and positive results of our programs, we presented the continued development progress of our programs at the following global events:
Annual National Institutes of Health (NIH) "Helping to End Addiction Long-term" (HEAL) Initiative Scientific Meeting, Bethesda, MD.
2024 American Association of Pain Medicine (AAPM) Meeting, Los Angeles, CA.
European Pharmaceutical Market Research Association (EPHMRA) Annual Conference, London, UK.
International Association for the Study of Pain (IASP) 2024 World Congress on Pain, Amsterdam, NL.
Society for Neuroscience Meeting, Chicago IL.
Formulation & Delivery US 2024, San Diego, CA.
18th Annual Pain Therapeutics Summit, Boston, MA.
Company led financing activities in 2024 that supported the significant milestones of our three programs included a warrant inducement transaction in February that provided
Additionally, in August, we received a non-dilutive
Looking ahead, we are focused on the continued rapid execution of our clinical development milestones for PF614 and PF614-MPAR. With the selection of a CRO, we intend to initiate activities in Q1 of 2025 to allow us to complete the PF614 Phase 3 study in 2025. Our current plans have us on track to submit our PF614 New Drug Application in 2026 with commercialization to follow. We are advancing our MPAR® program with our second clinical study underway. This safety and pharmacokinetic study will generate data for an interim review in the first quarter of 2025, which we will use to build the balance of the study dosing plan.
Our non-clinical OUD program is continuing, and following discussions with NIDA in early 2025, we expect to advance to Investigational New Drug (IND) enabling studies, with ambitions to initiate a Phase 1 study in 2026.
Altogether, we are incredibly proud of our accomplishments in 2024, completed with tightly managed resources. We believe 2025 will be another strong year for Ensysce, with pivotal data anticipated by year end. We are grateful to our committed shareholders in helping us achieve our goals. We remain confident in our potential to play a key role in providing safer pain medication for those suffering with severe pain, whether short-term or chronic, while we also provide options to address the prescription drug abuse crisis in the U.S. I look forward to sharing additional exciting milestones in the year to come.
Sincerely,
Dr. Lynn Kirkpatrick
Chief Executive Officer
About Ensysce Biosciences
Ensysce Biosciences is a clinical-stage pharmaceutical company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin-Activated Abuse Protection (TAAPTM) and Multi-Pill Abuse Resistance (MPAR®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and 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 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 SEC's website at www.sec.gov. Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law.
Ensysce Biosciences Company Contact:
Lynn Kirkpatrick, Ph.D.
Chief Executive Officer
(858) 263-4196
Ensysce Biosciences Investor Relations Contact:
Shannon Devine
MZ North America
Main: 203-741-8811
ENSC@mzgroup.us
SOURCE: Ensysce Biosciences Inc.
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FAQ
When will Ensysce Biosciences (ENSC) start Phase 3 trials for PF614?
How much funding did ENSC receive in 2024?
What is the significance of PF614-MPAR's Breakthrough Therapy designation?
When does ENSC expect to submit the New Drug Application for PF614?
What distinguishes PF614 from traditional oxycodone products?
