Full Press Release Details
Biosciences Reports First Quarter 2026 Financial Results
IRB Approval Secured for PF614-MPAR-102 Part 3 ~
Clinical Peer-Reviewed Data Published for First Overdose Protected Opioid PF614-MPAR ; Patent Estate Expanded ~
~Company Launches Formal Review of Strategic Alternatives ~
DIEGO, CA / May 15, 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 reported financial and operational results for the first quarter ended March 31, 2026.
first quarter of 2026 delivered meaningful operational and clinical momentum across our pipeline, underscoring the strength of our strategy
and the discipline of our execution," said Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce. We achieved 50% of
the interim enrollment target in our pivotal PF614-301 Phase 3 trial, published the first peer-reviewed clinical data validating our
MPAR overdose-protection technology, and expanded our patent estate across both our opioid and ADHD programs. Together
these milestones reinforce what we believe is the next evolution of opioid safety."
Kirkpatrick continued, "Following quarter-end, we closed a second financing tranche under an existing facility and secured IRB
approval to initiate Part 3 of PF614-MPAR-102, the final stage of that study. Advancing this program strengthens the clinical evidence
supporting a product we believe can fundamentally reshape how overdose risk is managed. In parallel, our Board has initiated a formal
review of strategic alternatives, including potential partnerships and licensing opportunities, to accelerate the development of our
TAAP and MPAR platforms and unlock additional shareholder value."
(Opioid Abuse Deterrent Program) Update
is the Company's lead product candidate and represents what we believe could be a next-generation extended-release oxycodone with
built-in abuse protection. Developed using our proprietary Trypsin-Activated Abuse Protection (TAAP ) technology, PF614 remains
inactive until it is swallowed and exposed to trypsin in the small intestine, where it "switches on" to release oxycodone
in a controlled manner.
targeted activation is designed to deliver effective pain relief while significantly reducing the potential for manipulation or
non-oral abuse. By making the active drug inaccessible until it reaches the digestive tract, TAAP aims to provide a safer opioid
option for patients with severe pain who require opioid-strength therapy. The Company believes this approach has the potential to meaningfully
differentiate PF614 within the multi-billion-dollar pain management market and address longstanding concerns around tampering and misuse.
January, Ensysce announced that it had enrolled 50% of the subjects targeted for interim review in its pivotal PF614-301 Phase 3 clinical
trial, a multicenter, randomized, double-blind, placebo-controlled study evaluating PF614 for the treatment of moderate to severe pain
following abdominoplasty. Enrollment, which began in late December 2025, progressed across two U.S. clinical sites; CenExel JBR
(Salt Lake City, Utah) and CenExel Atlanta (Decatur, Georgia), under principal investigators Dr. Todd Bertoch and Dr. Jessica McCoun,
recognized experts in anesthesiology and pain management. The study is designed to demonstrate PF614's ability to deliver consistent,
clinically meaningful post-surgical pain relief using twice-daily dosing while leveraging its built-in abuse protection chemistry. Achieving
the interim enrollment milestone in the early stages of the program brings Ensysce meaningfully closer to delivering interim data and
advancing what the Company believes could be a new standard in acute pain management.
(Opioid Abuse Deterrent and Overdose Protection Program) Update
is the Company's next-generation combination product that integrates both the TAAPTM and MPAR (Multi-Pill
Abuse Resistance) technology to deliver effective opioid analgesia with the added benefit of built-in oral overdose protection. By pairing
the PF614 prodrug with a trypsin inhibitor, PF614-MPAR is designed to "switch off" opioid release when supratherapeutic doses
are taken, offering a differentiated safety profile aimed at reducing overdose risk while maintaining therapeutic efficacy for patients
clinical data from the PF614-MPAR-101 study demonstrated that the MPAR mechanism performed as intended at a 25 mg dose,
providing the desired overdose protection. These results supported the FDA's decision to grant Breakthrough Therapy designation
in January 2024, a key regulatory milestone that underscores the potential for PF614-MPAR to address a significant unmet need in opioid
March, Ensysce announced the publication of the first peer-reviewed clinical manuscript describing its MPAR overdose
protection technology in the January/February 2026 issue of the Journal of Opioid Management. The paper, "Formulation and a Phase
1 Clinical Study of PF614-MPAR, an Oxycodone Prodrug with Oral Opioid Overdose Protection," reported that PF614-MPAR achieved appropriate
opioid plasma levels under normal dosing conditions while preventing large increases in exposure at supratherapeutic doses- reinforcing
the potential for a fundamentally new safety paradigm in opioid analgesia.
quarter end, in April 2026, Ensysce received Institutional Review Board (IRB) approval to initiate Part 3 of the PF614-MPAR-102
study, the final stage in evaluating the MPAR overdose-protection technology. Part 3 is designed to further characterize
PF614-MPAR s protective effect across multiple dosing scenarios, building on the previously published data demonstrating that the
product delivers therapeutic plasma levels under normal use while significantly limiting additional opioid exposure when higher-than-prescribed
doses are taken. The study continues with support from the National Institute on Drug Abuse (NIDA), reflecting ongoing external validation
of the program's potential impact.
is leveraging its TAAP and MPAR platforms beyond pain management to develop what could become the first abuse-deterrent,
overdose-protected stimulant therapies for attention-deficit/hyperactivity disorder (ADHD). The Company's ADHD pipeline includes
PF8026, a novel immediate-release amphetamine prodrug, and PF8001, an extended-release candidate. In January 2026, Ensysce received a
Notice of Allowance from the European Patent Office for a patent covering PF8026, with both composition-of-matter and method-of-use claims.
This strengthens the Company's intellectual property position and supports long-term value creation as it allows advancement of
safer stimulant options for a large and growing market. The need for innovation in ADHD therapeutics is significant. In 2023, approximately
3.9 million people aged 12 or older misused prescription stimulants, highlighting the limitations of current treatments and the urgency
for products engineered to resist common routes of abuse and incorporate overdose protection mechanisms. By applying TAAP and
MPAR to stimulant medications, Ensysce has the ability to address this unmet need and expand its platform into another
major therapeutic category with substantial commercial potential.
Use Disorder (OUD) Program Update
its pain management portfolio, Ensysce is advancing treatments for opioid use disorder (OUD) aimed at reducing cravings, lower relapse
risk, and improving long-term patient outcomes while maintaining patient safety and quality of life. The Company has selected PF9001
as its lead OUD candidate and is evaluating it as a potential next-generation alternative to methadone, with the added advantage of built-in
overdose protection, reduced cardiovascular risk and convenient oral delivery profile. The PF9001 program has been supported by a multi-year
HEAL (Helping to End Addiction Long-Term) grant and in collaboration with NIDA. This program support provides both scientific validation
and non-dilutive funding, reinforcing the potential of PF9001 to address critical gaps in current OUD treatment options and expand the
application of Ensysce's TAAP and MPAR technologies into another major public health challenge.
2026 Financial Results
- Cash and cash equivalents were $0.7 million as of March 31, 2026, compared to $4.3 million as of December 31, 2025. Subsequent
to March 31, 2026, on April 7, 2026, the Company closed a second tranche of $2.0 million in convertible preferred stock financing under
its previously announced November 2025 commitment for up to $20 million over 24 months.
Grants - Funding under federal grants totaled $1.0 million for the first quarter of 2026 compared to $1.3 million in the comparable
year ago quarter. This $0.3 million decrease is primarily due to the timing of research activities eligible for funding under the MPAR
& Development Expenses - R&D expenses were $3.3 million for the first quarter of 2026 compared to $1.9 million for the same
period in 2025, representing an increase of $1.4 million. The increase was primarily the result of external research and development
costs related to Phase 3 clinical trial activity for PF614.
& Administrative Expenses - G&A expenses were $1.2 million in the first quarter of 2026 and $1.4 million for the first quarter
of 2025, representing a decrease of $0.2 million.
Income (Loss) - Net loss attributable to common stockholders for the first quarter of 2026 was $3.6 million compared to a net loss
of $1.9 million for the first quarter of 2025. As a clinical stage biotech company, our continued research and development efforts toward
regulatory approvals for our product candidates are expected to result in losses for the foreseeable future.
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