Ensysce Biosciences Provides Shareholder Update, Responds to Recent Shareholder Inquiries
Ensysce Biosciences (NASDAQ:ENSC), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing opioid abuse potential, provided a shareholder update. Key points include:
1. The company believes it's in compliance with Nasdaq requirements and awaits a hearing to discuss maintaining compliance.
2. Ensysce raised $5 million in gross proceeds and received a $14 million NIH grant.
3. The PF614-301 Phase 3 Protocol for a pivotal study was submitted to the FDA, with results expected in late 2025.
4. PF614-MPAR studies are progressing with non-dilutive funding.
5. The company aims to submit a New Drug Application for PF614 by 2026, with potential commercialization by year-end.
6. Ensysce is in discussions with potential partners to expand commercial success of PF614 and PF614-MPAR.
Ensysce Biosciences (NASDAQ:ENSC), un'azienda farmaceutica in fase clinica che sviluppa soluzioni innovative per il sollievo dal dolore severo riducendo il potenziale di abuso di oppioidi, ha fornito un aggiornamento agli azionisti. I punti chiave includono:
1. L'azienda crede di essere conforme ai requisiti di Nasdaq e attende un'udienza per discutere il mantenimento della conformità.
2. Ensysce ha raccolto 5 milioni di dollari in proventi lordi e ha ricevuto una sovvenzione NIH di 14 milioni di dollari.
3. Il Protocollo PF614-301 Fase 3 per uno studio cruciale è stato presentato alla FDA, con risultati attesi entro la fine del 2025.
4. Gli studi PF614-MPAR stanno progredendo con finanziamenti non diluenti.
5. L'azienda mira a presentare una Nuova Domanda di Registrazione per PF614 entro il 2026, con una potenziale commercializzazione entro la fine dell'anno.
6. Ensysce è in trattative con potenziali partner per espandere il successo commerciale di PF614 e PF614-MPAR.
Ensysce Biosciences (NASDAQ:ENSC), una compañía farmacéutica en etapa clínica que desarrolla soluciones innovadoras para el alivio del dolor severo mientras reduce el potencial de abuso de opioides, proporcionó una actualización a los accionistas. Puntos clave incluyen:
1. La compañía cree que cumple con los requisitos de Nasdaq y espera una audiencia para discutir el mantenimiento de la conformidad.
2. Ensysce recaudó 5 millones de dólares en ingresos brutos y recibió una subvención del NIH de 14 millones de dólares.
3. El Protocolo PF614-301 Fase 3 para un estudio pivotal fue presentado a la FDA, con resultados esperados a finales de 2025.
4. Los estudios de PF614-MPAR están avanzando con financiamiento no dilutivo.
5. La compañía tiene como objetivo presentar una Nueva Solicitud de Medicamento para PF614 para 2026, con una posible comercialización para finales de año.
6. Ensysce está en conversaciones con socios potenciales para expandir el éxito comercial de PF614 y PF614-MPAR.
Ensysce Biosciences (NASDAQ:ENSC)는 중증 통증 완화를 위해 혁신적인 솔루션을 개발하며 오피오이드 남용 가능성을 줄이는 임상 단계 제약 회사로, 주주 업데이트를 제공했습니다. 주요 내용은:
1. 회사는 나스닥 요구 사항을 준수하고 있다고 믿으며, 준수 유지를 논의하기 위한 청문회를 기다리고 있습니다.
2. Ensysce는 500만 달러의 총 수익을 올리고 1400만 달러의 NIH 보조금을 받았습니다.
3. 중요한 연구를 위한 PF614-301 3상 프로토콜이 FDA에 제출되었으며, 결과는 2025년 말에 예상됩니다.
4. PF614-MPAR 연구는 비희석 자금 지원으로 진행되고 있습니다.
5. 회사는 2026년까지 PF614에 대한 새로운 약물 신청서를 제출할 계획이며, 연말까지 상업화될 가능성이 있습니다.
6. Ensysce는 PF614 및 PF614-MPAR의 상업적 성공을 확대하기 위해 잠재적인 파트너와 논의 중입니다.
Ensysce Biosciences (NASDAQ:ENSC), une société pharmaceutique en phase clinique qui développe des solutions innovantes pour le soulagement de la douleur sévère tout en réduisant le potentiel d'abus d'opioïdes, a fourni une mise à jour aux actionnaires. Les points clés incluent:
1. La société estime qu'elle se conforme aux exigences de Nasdaq et attend une audience pour discuter du maintien de la conformité.
2. Ensysce a levé 5 millions de dollars de produits bruts et a reçu une subvention de 14 millions de dollars de l'NIH.
3. Le protocole PF614-301 de Phase 3 pour une étude décisive a été soumis à la FDA, avec des résultats attendus fin 2025.
4. Les études PF614-MPAR progressent avec un financement non dilutif.
5. L'objectif de la société est de soumettre une nouvelle demande de médicament pour PF614 d'ici 2026, avec une commercialisation potentielle d'ici la fin de l'année.
6. Ensysce est en discussion avec des partenaires potentiels pour élargir le succès commercial de PF614 et PF614-MPAR.
Ensysce Biosciences (NASDAQ:ENSC), ein börsennotiertes Pharmaunternehmen in der klinischen Phase, das innovative Lösungen zur Schmerzlinderung bei schweren Schmerzen entwickelt und gleichzeitig das Potenzial für Opioidmissbrauch verringert, hat ein Update für die Aktionäre bereitgestellt. Die Schlüsselpunkte umfassen:
1. Das Unternehmen ist der Meinung, dass es die Anforderungen der Nasdaq erfüllt und wartet auf eine Anhörung zur Diskussion über die Aufrechterhaltung der Compliance.
2. Ensysce hat 5 Millionen Dollar brutto eingenommen und einen NIH-Zuschuss von 14 Millionen Dollar erhalten.
3. Das PF614-301 Phasen-3-Protokoll für eine entscheidende Studie wurde der FDA vorgelegt, mit Ergebnissen, die Ende 2025 erwartet werden.
4. Die Studien zu PF614-MPAR schreiten mit nicht dilutiven Finanzierungen voran.
5. Das Unternehmen plant, bis 2026 einen neuen Arzneimittelantrag für PF614 einzureichen, mit einer möglichen Vermarktung bis Ende des Jahres.
6. Ensysce führt Gespräche mit potenziellen Partnern, um den kommerziellen Erfolg von PF614 und PF614-MPAR auszubauen.
- Raised $5 million in gross proceeds from a financing transaction
- Received a $14 million multi-year grant from NIH for PF614-MPAR studies
- Submitted PF614-301 Phase 3 Protocol to FDA for pivotal study
- Initiated non-clinical studies for PF614-MPAR NDA
- Received IRB approval for PF614-MPAR-102 protocol
- On track to submit PF614 New Drug Application by 2026
- In discussions with potential partners for commercial expansion
- Awaiting Nasdaq hearing to discuss maintaining compliance with listing requirements
- Additional funding required for FDA approval and commercialization process
SAN DIEGO, CA / ACCESSWIRE / October 2, 2024 / 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 provides a response from Chief Executive Officer, Dr. Lynn Kirkpatrick, regarding recent inquiries from stockholders and other interested parties.
Dear Fellow Stockholders,
It is important to me to directly deliver an update to our supportive shareholders, stakeholders and partners, by addressing some questions we have recently received and providing a concise view of our development progress and timelines.
What is the latest update from the Company in terms of Nasdaq listing requirements?
As of September 30, 2024, we believe we are in compliance with Nasdaq requirements regarding stockholders' equity and we are looking forward to the upcoming hearing with Nasdaq to discuss our plans to continue to maintain compliance with both the stockholders' equity requirement and the
How much cash does Ensysce have to continue to make progress on its initiatives?
In August, the Company completed a financing transaction which raised
What are the latest plans and timeline of the PF614-301 protocol of the study, "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"?
We submitted our PF614-301 Phase 3 Protocol to the FDA for our pivotal Phase 3 study, as announced on September 19, 2024. This study is designed to assess the analgesic efficacy of PF614 compared to placebo in subjects with moderate-to-severe pain following abdominoplasty. Results from the study are expected in late 2025.
Next Steps: We await feedback on the protocol from the FDA. A Clinical Advisory Board meeting is planned for early November in which we will review the feedback and incorporate any advice into our study plans. Steps are being taken to identify clinical sites, and study management proposals have been solicited and received from interested Contract Research Organizations.
Following receipt of grant funding for development of PF614-MPAR, will you provide the progress of the current clinical trial and frame out the remainder of trials to FDA approval?
With
What additional components are required in terms of achieving FDA approval and commercialization of PF614?
Besides completing the necessary Phase 3 clinical studies to gain FDA approval, outlined above, Ensysce has partnerships in place with both drug substance and drug product contract development and manufacturing organizations to scale our manufacturing needs for production of clinical trial material, registrational material and commercial material for our first drug launch. In addition, we have received proposals from packaging and labeling facilities, and we are finalizing the steps needed to have commercial product in place to be shipped as soon as we receive approval from the FDA.
Subject to raising additional funds, which cannot be assured, we are on track to submit our PF614 New Drug Application by 2026 and commercialization to follow by end of that year.
Is ENSC evaluating strategic partnerships or indications of interest in terms of funding a safer opioid option and expedite commercialization?
Ensysce has been in discussions with several interested partners to expand the commercial success of PF614 and PF614-MPAR. We are committed to leveraging cash and non-cash resources to reach our objectives.
What action do you have in place to enhance shareholders' value?
We have been executing our clinical and development strategy with positive results over the last several years. We continue to make progress in all of our programs, including Breakthrough Therapy designation from the FDA and the successful completion of a bioequivalence clinical study for our oral overdose protected opioid, PF614-MPAR. We have also successfully completed two Human Abuse Potential studies for PF614. We continue to forge forward despite the outside pressure of a difficult macro environment for microcap companies.
If you have additional questions that were not answered today, please submit them to ENSC@mzgroup.us.
About Ensysce Biosciences
Ensysce Biosciences is a clinical-stage company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin-Activated Abuse Protection (TAAP™) 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 its 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.
View the original press release on accesswire.com
FAQ
What is the current status of Ensysce Biosciences (ENSC) regarding Nasdaq listing requirements?
How much funding has Ensysce Biosciences (ENSC) recently secured?
What is the timeline for Ensysce Biosciences' (ENSC) PF614-301 Phase 3 study?
When does Ensysce Biosciences (ENSC) plan to submit the New Drug Application for PF614?
Is Ensysce Biosciences (ENSC) considering strategic partnerships for commercialization?
