Full Press Release Details
Biosciences Reports Second Quarter 2025 Financial Results and Latest Program Updates
Critical Milestone, Launching Phase 3 Trial of PF614 to Advance Next-Generation Opioid Therapy Toward Regulatory Approval
$5.3 Million Installment from NIDA To Support Overdose Protection Program
PF614-MPAR-102 Study with Full Enrollment of Part 2
DIEGO, CA / August 13, 2025 / Ensysce Biosciences, Inc. (NASDAQ: ENSC) ("Ensysce" or the "Company"), a clinical-stage
pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose,
today reported financial and operational results for the second quarter ended June 30, 2025.
Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "Momentum continued in the second quarter as we forged ahead progressing,
what we believe will be the next evolution in opioid therapeutics: safety features built in to help guard against both misuse and overdose.
The initiation of our pivotal Phase 3 trial for PF614 marks a major achievement for Ensysce and a critical step toward achieving our
clinical and commercial strategy. This study is designed to validate PF614's ability to deliver what we believe will be superior
pain relief for post-surgical pain with built-in abuse deterrence, reinforcing our commitment to developing safer opioid therapies. As
we advance to seeking regulatory approval, PF614 has the potential to reshape the opioid treatment landscape and create long-term value
for both patients and shareholders."
Kirkpatrick added, "Fully enrolling Part 2 of our PF614-MPAR-102 study marks another important step in progressing this product
with built in overdose-protection. With continued financial support from NIDA and the FDA's Breakthrough Therapy designation, we
are accelerating the development of what could be a game-changing solution for those in severe pain, one that not only has superior efficacy
but is designed to prevent unintentional overdose."
the significant advancements made to date, we believe Ensysce is well-positioned to disrupt the opioid analgesic market with our lead
candidates, PF614 and PF614-MPAR. Our approach leverages innovative chemistry to create opioid therapies that maintain strong efficacy
while incorporating built-in safeguards against abuse and overdose. As we progress through the second half of the year, we are executing
on a clear path of clinical and regulatory milestones across our TAAP , MPAR , and overdose use disorder (OUD) programs. With
the opioid crisis continuing to take a devastating toll, our mission remains focused on saving lives and transforming how patients with
pain and addiction are treated," Dr. Kirkpatrick concluded.
(Opioid Abuse Deterrent Program) Update
Company's lead product, PF614, is a Trypsin-Activated Abuse Protection (TAAPTM) extended-release oxycodone and a potential
"next generation" analgesic to treat severe pain. PF614's TAAPTM chemical modification of oxycodone renders
it inactive until it is swallowed and exposed to the body's own trypsin in the small intestine to activate or "switch on"
to release oxycodone. The TAAPTM technology is designed to control release when administered orally, be highly resistant to
tampering, and reduce abuse, with a goal of providing a safer opioid product for those suffering from severe pain who require opioid-strength
July, Ensysce announced the initiation of its pivotal PF614-301 study evaluating PF614, to manage and moderate severe post-surgical pain
after abdominoplasty. The study aims to demonstrate PF614's effectiveness in pain relief while minimizing the risk of abuse and
supporting a safer transition to non-opioid outpatient care. Ensysce has engaged Rho, Inc., a clinical research organization with deep
expertise in central nervous system (CNS) disorders and pain studies, to conduct the trial. The collaboration marks a major step toward
redefining pain therapy with a safer class of opioids.
(Opioid Abuse Deterrent and Overdose Protection Program) Update
is a combination product of the TAAPTM and MPAR (Multi-Pill Abuse Resistance) technology to treat severe pain with the
added benefit of oral overdose protection. PF614-MPAR combines prodrug PF614 with a trypsin inhibitor to reduce or "switch off"
the release of the opioid in an overdose situation. Data from the initial clinical trial PF614-MPAR-101, demonstrating that the MPAR
technology worked as designed to provide the desired overdose protection to PF614-MPAR at a 25 mg dose, led to the FDA's Breakthrough
Therapy designation in January 2024.
the second quarter of 2025, the Company completed enrollment for Part 2 of its PF614-MPAR-102 study, to examine how food affects its
MPAR technology, and is awaiting final data. The study is continuing with the third part of the trial through end of year and the Company
is continuing to complete non-clinical studies required to support its use for chronic pain. PF614-MPAR, which combines Ensysce's
TAAP and MPAR technologies, has received FDA Breakthrough Therapy designation for its potential to prevent overdose while
maintaining pain relief. Supported by a multi-year grant from the National Institute on Drug Abuse (NIDA), the program is advancing toward
a new class of opioids designed to reduce the risks of abuse and overdose, a major step toward transforming pain management.
addition to its pain management pipeline, Ensysce is advancing innovative treatments for opioid use disorder, including novel compounds
designed to reduce cravings and prevent relapse without compromising quality of life. Leveraging its proprietary TAAP and MPAR
technologies, the Company is developing what may be a safer methadone alternative. In 2024, Ensysce selected PF9001 as its lead OUD candidate,
evaluating it for oral delivery, reduced cardiovascular risk, and built-in overdose protection. Supported by a multi-year HEAL (Helping
to End Addiction Long-Term) grant from NIDA, the program is progressing toward non-clinical studies to support a future Investigational
New Drug (IND) application. In a key milestone during the quarter, Ensysce also received a Notice of Allowance from the U.S. Patent and
Trademark Office for a patent covering the composition and use of PF9001, further strengthening its intellectual property position in
2025 Financial Results
- Cash and cash equivalents were $2.2 million as of June 30, 2025, compared to $3.5 million as of December 31, 2024. During
the quarter, the Company was awarded the second $5.3 million installment of a $15 million, three-year grant from the National Institute
on Drug Abuse (NIDA)1. These funds are available for reimbursement of research and development expenses under the MPAR program
Grants - Funding under federal grants totaled $1.4 million for the second quarter of 2025, compared to $0.2 million in the
same quarter of 2024. The $1.2 million difference is due to the timing of research activities eligible for funding, with increased clinical
activities in 2025 for the PF614-MPAR-102 study under the MPAR grant which began in September 2024.
& Development Expenses - R&D expenses were $1.9 million for the second quarter of 2025 compared to $0.9 million for
the same period in 2024. The increase was primarily the result of external research and development costs related to PF614-MPAR, with
increased pre-clinical and clinical activity in the 2025 period.
& Administrative Expenses - G&A expenses were constant at $1.2 million in the second quarter of both 2025 and 2024.
Income (Expense) - Total other income (expense) was income of $16,998 for the second quarter of 2025 compared to expense of
$12,351 in the same period of 2024.
Income (Loss) - Net loss attributable to common stockholders for the second quarter of 2025 was $1.7 million compared to a
net loss of $2.0 million for the second quarter of 2024. As a clinical-stage biotech company, the Company's continued research
and development efforts toward regulatory approvals for its product candidates are expected to result in losses for the foreseeable future.
research is supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number UO1DA059791.
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.
trypsin activated abuse protection - designed to protect against prescription drug abuse.
multi-pill abuse resistance - designed to protect against abuse and accidental overdose.
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.
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