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Ensysce Biosciences Awarded $5.3 Million Installment in NIDA Funding Completing Multi-Year $15 Million Federal Grant

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Ensysce Biosciences (NASDAQ: ENSC) received a new $5.3 million installment from the National Institute on Drug Abuse (NIDA), marking the third consecutive year of support and completing a multi‑year $15.1 million federal grant for its MPAR® overdose‑protection technology and lead candidate PF614‑MPAR.

According to Ensysce, this funding will finance completion of the PF614‑MPAR‑102 clinical study and required long‑term non‑clinical work supporting a future New Drug Application. PF614‑MPAR, which has U.S. FDA Breakthrough Therapy designation, is designed to actively limit opioid release in oral overdose situations via a proprietary chemical control mechanism.

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Positive

  • $5.3 million third‑year NIDA installment received
  • Multi‑year NIDA grant completed at $15.1 million total funding
  • Funding supports completion of PF614‑MPAR‑102 clinical study
  • Grant covers long‑term non‑clinical work toward PF614‑MPAR NDA
  • PF614‑MPAR holds U.S. FDA Breakthrough Therapy designation

Negative

  • None.

News Explained

The grant is complete as an award, but the release does not establish that its final installment is already cash on Ensysce’s balance sheet.

The July 14 release reports receipt of a NIDA Notice of Award for the final $5.3 million installment, completing the stated $15.1 million grant at the award level; it designates support for PF614-MPAR-102 completion and long-term non-clinical work, but does not state that the installment has been disbursed as cash.

Against Ensysce’s first-quarter figures, reported cash and equivalents equaled 19.2 days of that quarter’s operating cash use, while the full award’s stated size equaled 388.2 days on the same historical basis; these are sizing comparisons, not evidence that award cash is currently available.

Sources and calculations
  • Offering gross vs quarterly operating cash outflow, in days of cash use $15,100,000 / ($3,500,925 / 90) = [object Object]
  • Cash and equivalents vs quarterly operating cash outflow, in days of cash use $745,482 / ($3,500,925 / 90) = [object Object]

Market reaction after NIDA grant funding award: ENSC +6.17% in the Jul 14 session

+6.17% 24.7x vol
51 alerts
+6.17% Session close to close
+31.5% Peak Tracked
-17.3% Trough Tracked
$4.23M Market Cap
24.7x Rel. Volume

In the Jul 14 session, ENSC gained 6.17%, reflecting a notable positive market reaction. Argus tracked a peak move of +31.5% during that session. Argus tracked a trough of -17.3% from its starting point during tracking. Our momentum scanner triggered 51 alerts that day, indicating high trading interest and price volatility. Trading volume was exceptionally heavy at 24.7x the daily average, suggesting very strong buying interest.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved +6.2% in the session following this news. If a sharp upside move followed, investors...
Analysis

The stock moved +6.2% in the session following this news. If a sharp upside move followed, investors may have focused on the fresh $5.3 million NIDA installment completing a $15.1 million grant. Prior NIDA- and trial-related news has produced strong gains, including a 6.33% and 13.17% jump on recent updates, while low short positioning limits squeeze dynamics.

Key Figures

NIDA installment: $5.3 million Total NIDA award: $15.1 million Opioid overdose deaths: nearly 80,000 people +1 more
4 metrics
NIDA installment $5.3 million Notice of Award to support MPAR overdose-protection technology development
Total NIDA award $15.1 million Multi-year federal grant supporting MPAR non-clinical and clinical development
Opioid overdose deaths nearly 80,000 people Estimated annual U.S. deaths linked to opioid overdoses
Funding year third consecutive year Third year of NIDA funding under the same MPAR award

Historical Context

5 past events · Latest: Jun 26 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jun 26 Clinical trial progress Positive +6.3% First patient enrolled in final phase of PF614-MPAR-102 clinical study.
May 15 Earnings update Positive +13.2% Q1 2026 results with financing, trial progress, and strategic review update.
May 12 Patent expansion Positive -17.1% New Taiwan patent extending MPAR overdose-protection coverage through 2042.
May 08 Conference presentation Positive -5.3% CEO talk at Pain Therapeutics Summit Europe on TAAP and MPAR platforms.
Apr 16 Clinical trial approval Positive -4.7% IRB approval to start Part 3, final stage of PF614-MPAR-102 study.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent ENSC news has produced mixed reactions, with some positive clinical and funding updates rallying the stock but several similarly positive items selling off.

Key Terms

breakthrough therapy, new drug application, nda, attention‑deficit/hyperactivity disorder
4 terms
breakthrough therapy regulatory
"PF614-MPAR, which received Breakthrough Therapy designation from the U.S. FDA"
A breakthrough therapy is a regulatory designation granted to an experimental drug or treatment when early clinical evidence indicates it could offer a substantial improvement over existing options for a serious or life‑threatening condition. For investors it matters because the label brings faster, more intensive interaction with regulators and can shorten development and review time—like a VIP fast‑track toward potential approval, reducing time and risk before a product can reach the market.
new drug application regulatory
"required for ultimate submission in the New Drug Application (NDA) for PF614‑MPAR"
A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.
nda regulatory
"required for ultimate submission in the New Drug Application (NDA) for PF614‑MPAR"
An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.
attention‑deficit/hyperactivity disorder medical
"including amphetamines and methadone, with the goal of providing safer treatment options for pain, attention‑deficit/hyperactivity disorder (ADHD), and opioid use disorder"
A neurodevelopmental condition marked by persistent patterns of inattention, hyperactivity, and impulsivity that interfere with daily functioning and learning. It matters to investors because it creates demand for medications, behavioral therapies, diagnostic tools, and support services, and influences market size, clinical trial activity, regulatory review, and long‑term healthcare and workplace costs—think of it as a brain’s attention-control system that struggles to filter distractions.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Funds Advance FDA-Designated Breakthrough Therapy First-in-Class Opioid with Oral Overdose-Protection

SAN DIEGO, CA / ACCESS Newswire / July 14, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering next-generation pain and central nervous system therapeutics engineered to minimize abuse and overdose risk, today announced receipt of a Notice of Award for $5.3 million from the National Institutes on Drug Abuse (NIDA)1 to support the development of its novel MPAR® (Multi-Pill Abuse Resistance) overdose-protection technology, and the lead agent, PF614-MPAR. This marks the third consecutive year of NIDA funding under this award, reflecting sustained institutional confidence in the MPAR® program as it progresses toward late-stage development.

This third year of funding completes Ensysce's $15.1 million award, which has enabled the Company to advance both the non‑clinical and clinical development of its novel MPAR® overdose‑protection technology. The award will support completion of the PF614‑MPAR‑102 study, as well as the long‑term non‑clinical studies required for ultimate submission in the New Drug Application (NDA) for PF614‑MPAR.

PF614-MPAR, which received Breakthrough Therapy designation from the U.S. FDA following their review of the initial clinical data from study PF614-101, represents a fundamentally new approach to opioid safety. Unlike conventional abuse-deterrent formulations, PF614-MPAR is designed to provide active protection against oral overdose-addressing a critical unresolved risk in opioid therapy. PF614-MPAR uses a proprietary chemical control mechanism that maintains therapeutic opioid exposure under prescribed use, while automatically limiting additional opioid release when excessive doses are ingested. This "built-in safety switch" introduces a new therapeutic paradigm: opioids engineered not only for efficacy, but for controlled exposure under conditions of misuse.

Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, noted that nearly 80,000 people in the U.S. die each year from opioid overdoses, with prescription opioids playing a significant role in the crisis2. "This continued NIDA funding allows us to keep advancing MPAR®, a new class of chemically engineered opioids designed to actively safeguard patients, even in situations involving misuse or dosing mistakes. This innovation marks an important step toward setting a new standard for opioid safety," she stated.

Beyond pain management, Ensysce's underlying TAAP™ and MPAR® platforms are designed to apply across multiple drug classes, an approach the Company is extending into additional therapeutic areas, including amphetamines and methadone, with the goal of providing safer treatment options for pain, attention‑deficit/hyperactivity disorder (ADHD), and opioid use disorder.

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

2 https://drugabusestatistics.org/opioid-epidemic/

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, Inc.



View the original press release on ACCESS Newswire

FAQ

What does the new $5.3 million NIDA installment mean for Ensysce Biosciences (NASDAQ: ENSC)?

The new $5.3 million NIDA installment provides Ensysce with continued non‑dilutive funding to progress PF614‑MPAR. According to Ensysce, it completes a multi‑year grant and supports both clinical and long‑term non‑clinical studies needed for a future New Drug Application.

How much total NIDA funding has Ensysce Biosciences (ENSC) received for its MPAR program?

Ensysce reports receiving a total of $15.1 million in NIDA funding for its MPAR® overdose‑protection program. According to Ensysce, this multi‑year award has supported both non‑clinical and clinical development, including current work on PF614‑MPAR and required studies for a potential NDA.

What is PF614-MPAR and why is it important for Ensysce Biosciences (ENSC)?

PF614‑MPAR is Ensysce’s lead MPAR® opioid candidate, designed to limit oral overdose by chemically controlling opioid release. According to Ensysce, it maintains therapeutic exposure under prescribed use and automatically restricts additional opioid release when excessive doses are ingested, creating a built‑in safety mechanism.

How will Ensysce use the latest NIDA funds in its PF614-MPAR development?

Ensysce plans to use the latest NIDA funds to complete the PF614‑MPAR‑102 clinical study and key long‑term non‑clinical studies. According to Ensysce, these activities are required to support an eventual New Drug Application submission for PF614‑MPAR in the United States.

Does PF614-MPAR from Ensysce (ENSC) have FDA Breakthrough Therapy designation?

Yes, PF614‑MPAR has received Breakthrough Therapy designation from the U.S. FDA. According to Ensysce, this followed FDA review of initial clinical data from study PF614‑101 and recognizes PF614‑MPAR’s novel approach to improving opioid safety under conditions of misuse.

How does Ensysce’s MPAR technology aim to reduce opioid overdose risk?

Ensysce’s MPAR® technology is designed to provide active oral overdose protection by limiting opioid release when excessive doses are taken. According to Ensysce, a proprietary chemical mechanism maintains therapeutic levels during prescribed use while automatically constraining additional exposure in potential misuse scenarios.

Beyond pain management, what other areas could Ensysce’s TAAP and MPAR platforms target?

Ensysce is extending its TAAP™ and MPAR® platforms into additional drug classes, including amphetamines and methadone. According to Ensysce, the goal is to enable safer treatments in areas such as pain, attention‑deficit/hyperactivity disorder (ADHD), and opioid use disorder.