Ensysce Biosciences Announces Commercial Supplier for Breakthrough Overdose Protection Drug Product

Rhea-AI Summary

Ensysce Biosciences (NASDAQ:ENSC) has secured a commitment for future supply of GMP nafamostat from Aurore Life Sciences. This agreement is important for PF614-MPAR, the company's overdose protection drug product, as nafamostat is a vital component. The partnership allows Ensysce to reference Aurore's Drug Master File and fully secures the supply chain for PF614-MPAR, which is currently advancing through clinical development. Additionally, the company has initiated other programs using nafamostat as a single agent for various indications, which will also benefit from this supply agreement.

Positive

• Secured future supply commitment for critical component nafamostat
• Supply chain fully secured for PF614-MPAR development
• Access granted to Aurore Life Sciences' Drug Master File
• Potential for additional applications of nafamostat in other programs

Negative

• None.

Insights

Medical Research Analyst

The supply chain agreement for nafamostat, while a positive development, represents a relatively minor operational milestone at this stage. While securing GMP-grade nafamostat is necessary for PF614-MPAR's development, this news doesn't materially impact the company's near-term prospects or timeline to market. The agreement with Aurore Life Sciences primarily addresses manufacturing logistics rather than advancing clinical development or regulatory approval.

For a micro-cap biotech company ($9.5M market cap), having a secure supply chain is important but not a significant value driver. The real catalysts will come from clinical trial results, FDA interactions and potential partnerships. This news reduces some operational risk but doesn't accelerate revenue potential or change the fundamental investment thesis.

The mention of additional nafamostat programs suggests pipeline expansion possibilities, but without specific details or timelines, the impact remains speculative. Investors should focus more on upcoming clinical milestones for PF614-MPAR rather than this supply agreement.

~ Supply Chain Now Fully Secure for PF614-MPAR ~

SAN DIEGO, CA / ACCESSWIRE / December 10, 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 announced the receipt of commitment of future supply of GMP nafamostat, a critical component of PF614-MPAR. This agreement fully secures the supply chain and allows Ensysce to reference the nafamostat Drug Master File of Aurore Life Sciences, a renowned specialty drug manufacturer.

Dr. Lynn Kirkpatrick commented, "We are pleased to have received this early interest and commitment from Aurore as nafamostat is a vital component of our overdose protection program PF614-MPAR. Having a secure supply of this drug substance will accelerate our finalizing the drug product for PF614-MPAR, which is rapidly moving through clinical development. Ensysce has initiated additional programs with nafamostat as a single agent for other indications which will also benefit from this commitment, so we welcome Aurore as a critical partner in our pipeline development."

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 (TAAP^TM) 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.

About Aurore Life Sciences
Aurore Life Sciences, established in 2017, is a leading manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediates, offering high-quality, affordable bulk drug solutions to over 55 countries worldwide. With a pure-play focus on APIs and intermediates, Aurore is a fully backward-integrated pharmaceutical company dedicated to delivering to all regulated markets globally.

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:
MZ Group North America
Shannon Devine
203-741-8811
ENSC@mzgroup.us

SOURCE: Ensysce Biosciences Inc.

View the original press release on accesswire.com

FAQ

What is the significance of Ensysce Biosciences' (ENSC) agreement with Aurore Life Sciences?

The agreement secures the future supply of GMP nafamostat, a critical component for Ensysce's PF614-MPAR overdose protection drug product, and allows access to Aurore's Drug Master File.

What is PF614-MPAR being developed for by Ensysce Biosciences (ENSC)?

PF614-MPAR is being developed as an innovative solution for severe pain relief with reduced potential for opioid abuse and overdose.

How will nafamostat be used in Ensysce Biosciences' (ENSC) product development?

Nafamostat will be used as a vital component in PF614-MPAR and in additional programs as a single agent for other indications.