Ensysce Biosciences Announces Broader Patent Protection for Groundbreaking MPAR(R) Overdose Protection Technology

Rhea-AI Summary

Ensysce Biosciences (NASDAQ:ENSC) announced a U.S. Notice of Allowance for a new patent covering its MPAR® overdose protection technology, extending MPAR patent coverage through 2042. The patent titled "Compositions Comprising Enzyme-Cleavable Prodrugs and Controlled Release Nafamostat and Methods of Use Thereof" includes composition-of-matter and method-of-use claims to strengthen the company’s IP estate. MPAR earned Breakthrough Therapy Designation from the FDA in January 2025. Clinical testing of PF614-MPAR reportedly showed effective pain relief when taken as prescribed and reduced excessive opioid delivery when multiple doses were taken. Ensysce is also applying MPAR to other drug classes and is conducting a second clinical trial to further evaluate the technology.

Positive

• Patent protection extended through 2042
• Composition and method claims strengthen IP estate
• FDA Breakthrough Therapy designation received Jan 2025
• Clinical data: PF614-MPAR reduced excessive opioid delivery in trials

Negative

• Lead candidates remain in clinical development, not approved
• Second clinical trial is ongoing, outcomes uncertain

News Market Reaction

-4.57%

6 alerts

-4.57% News Effect

+9.2% Peak Tracked

-12.3% Trough Tracked

-$265K Valuation Impact

$6M Market Cap

0.9x Rel. Volume

On the day this news was published, ENSC declined 4.57%, reflecting a moderate negative market reaction. Argus tracked a peak move of +9.2% during that session. Argus tracked a trough of -12.3% from its starting point during tracking. Our momentum scanner triggered 6 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $265K from the company's valuation, bringing the market cap to $6M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

MPAR patent coverage: through 2042

1 metrics

MPAR patent coverage through 2042 New U.S. patent for MPAR overdose protection technology

Market Reality Check

Price: $0.8850 Vol: Volume 275,035 is below t...

low vol

$0.8850 Last Close

Volume Volume 275,035 is below the 20-day average of 407,305 (relative volume 0.68). low

Technical Price 1.42 is trading below the 200-day MA of 2.42, indicating a longer-term downtrend.

Peers on Argus

ENSC is up 11.27% with mixed peer moves: PLRZ up 13.7%, while SILO, TTNP, and NC...

ENSC is up 11.27% with mixed peer moves: PLRZ up 13.7%, while SILO, TTNP, and NCNA are down modestly. With no peers in the momentum scanner and limited same-day biotech strength, the move appears stock-specific.

Historical Context

5 past events · Latest: Dec 09 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 09	Phase 3 enrollment	Positive	-11.3%	First patient enrolled in pivotal Phase 3 PF614 pain trial.
Dec 02	Patent expansion	Positive	-4.6%	New MPAR patent extends overdose protection IP coverage through 2042.
Nov 20	FDA manufacturing feedback	Positive	-12.0%	FDA agrees with PF614 manufacturing approach, enabling commercial-scale production.
Nov 17	Convertible financing	Neutral	-4.8%	$4M convertible preferred deal with up to $16M additional tranches.
Nov 14	Q3 results	Neutral	-4.8%	Q3 2025 results with low cash, grant funding, and ongoing net loss.

Pattern Detected

Recent positive operational and financing news has often been followed by negative 24h price reactions, suggesting a pattern of selling into good news.

Recent Company History

Over the last few months, Ensysce reported multiple advances across its pipeline and financing. A pivotal Phase 3 PF614 trial began in July 2025 and enrollment of the first patient was announced on Dec 09, 2025. The company also gained broader MPAR patent protection through 2042 and positive FDA feedback on PF614 manufacturing. Financing in November 2025 raised up to $20.0M potential capital, while Q3 2025 results highlighted limited cash and ongoing grant support. Despite these updates, prior 24h price reactions were negative, making today’s positive move a departure from that trend.

Market Pulse Summary

This announcement strengthens Ensysce’s intellectual property by extending MPAR overdose protection ...

Analysis

This announcement strengthens Ensysce’s intellectual property by extending MPAR overdose protection coverage through 2042, building on FDA Breakthrough Therapy Designation and prior clinical data for PF614-MPAR. In recent months, the company also advanced a pivotal PF614 Phase 3 trial and secured new financings involving preferred stock and warrants, while reporting limited cash and ongoing losses. Investors may watch future clinical readouts, additional funding steps, and balance-sheet developments to gauge execution and risk.

Key Terms

breakthrough therapy designation, prodrugs, controlled release, opioid use disorder

4 terms

breakthrough therapy designation regulatory

"MPAR®, which earned Breakthrough Therapy Designation from the U.S. Food and Drug"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

prodrugs medical

"titled "Compositions Comprising Enzyme-Cleavable Prodrugs and Controlled Release"

Prodrugs are medicine compounds designed to be inactive or less active when taken and then converted inside the body into the active drug. Like a packaged meal that needs cooking before it can be eaten, they can improve how a medicine is absorbed, reduce side effects, or extend patent and dosing advantages; investors watch prodrugs because these properties affect regulatory approval, market competitiveness, development costs, and potential revenue.

controlled release medical

"Enzyme-Cleavable Prodrugs and Controlled Release Nafamostat and Methods of Use"

Controlled release is a drug formulation designed to release its active ingredient steadily over a set period instead of all at once, providing a predictable dose in the body. For investors, this matters because steady dosing can improve patient adherence and safety, support stronger regulatory and patent positions, and differentiate products in the market—think of it like a slow‑melting ice cube that supplies water steadily rather than a single splash.

opioid use disorder medical

"amphetamines and methadone, to develop safer treatments for pain, ADHD, and opioid use disorder."

Opioid use disorder is a medical condition where a person repeatedly seeks and uses opioid drugs despite harmful physical, social or mental effects, often involving strong cravings and withdrawal symptoms when stopping. It matters to investors because its prevalence, availability of effective treatments, regulatory responses, and legal or insurance costs can shift demand, revenue and risk across drug makers, treatment providers and insurers—like a widespread problem that reshapes an entire market.

AI-generated analysis. Not financial advice.

~ New U.S. Patent Extends Protection Through 2042 ~

~ Patent Allowance Secures Highest Level of Intellectual Property Protection for MPAR^® ~

SAN DIEGO, CA / ACCESS Newswire / December 2, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering next-generation pain and central nervous system therapeutics designed to minimize abuse and overdose risk, today announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for a new patent covering Ensysce's MPAR® (Multi-Pill Abuse Resistance) technology. The patent, titled "Compositions Comprising Enzyme-Cleavable Prodrugs and Controlled Release Nafamostat and Methods of Use Thereof", includes both composition-of-matter and method-of-use claims that strengthen Ensysce's intellectual property estate for its unique overdose protection platform. The new protection extends the Company's MPAR^® patent coverage through 2042.

MPAR^®, which earned Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) in January 2025, is designed to limit the effects of opioid exposure in the event of an overdose. In clinical testing, PF614-MPAR demonstrated effective pain relief when taken as prescribed, while preventing excessive opioid delivery when multiple doses were administered. Beyond opioids, Ensysce is applying its MPAR^® technology to additional drug classes, including amphetamines and methadone, to develop safer treatments for pain, ADHD, and opioid use disorder.

"This new patent represents another important milestone in our mission to make vital and proven medicines safer," said Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce. "MPAR^® overdose protection, in combination with our TAAP™ abuse-deterrent platform, delivers a dual safety approach which we believe is unlike anything else in the field. We are grateful for support and funding from the National Institute on Drug Abuse¹ that has allowed us to demonstrate clinically that MPAR moderates opioid release when taken in excess. The second clinical trial to further evaluate the potential of this technology is ongoing. We are striving to advance both PF614 and PF614-MPAR through late clinical development to achieve our goal of reducing opioid abuse and overdose."

¹Research supporting this patent was funded by the National Institute on Drug Abuse of the National Institutes of Health under Award Number DA047682.

About Ensysce Biosciences
Ensysce Biosciences is a clinical-stage company with a goal of disrupting the analgesic landscape by introducing a new class of highly novel opioids for the treatment of severe pain. 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. 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, possible NASDAQ delisting, 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; continuation of government funding; 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, 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

View the original press release on ACCESS Newswire

FAQ

What patent did Ensysce (ENSC) receive on December 2, 2025 and how long does it extend MPAR protection?

Ensysce received a Notice of Allowance for a patent titled "Compositions Comprising Enzyme-Cleavable Prodrugs and Controlled Release Nafamostat and Methods of Use Thereof," extending MPAR protection through 2042.

What clinical results did PF614-MPAR show in Ensysce (ENSC) trials?

PF614-MPAR reportedly provided effective pain relief when taken as prescribed and prevented excessive opioid delivery when multiple doses were administered.

Does the Ensysce (ENSC) MPAR patent include composition and method claims?

Yes, the allowed patent includes both composition-of-matter and method-of-use claims for the MPAR technology.

What regulatory recognition has Ensysce (ENSC) received for MPAR?

MPAR earned FDA Breakthrough Therapy Designation in January 2025.

Is Ensysce's (ENSC) MPAR technology being applied beyond opioids?

Yes, Ensysce is applying MPAR to other drug classes including amphetamines and methadone for treatments such as ADHD and opioid use disorder.

What is the near-term development status for Ensysce (ENSC) PF614-MPAR?

A second clinical trial is ongoing as the company seeks late-stage development advancement for PF614 and PF614-MPAR.