Ensysce Biosciences Reports Second Quarter 2025 Financial Results and Latest Program Updates
Ensysce Biosciences (NASDAQ:ENSC) reported significant progress in Q2 2025 for its innovative opioid therapy programs. The company initiated a pivotal Phase 3 trial for PF614, its lead candidate for severe pain with built-in abuse deterrence. Additionally, Ensysce completed enrollment for Part 2 of the PF614-MPAR-102 study, advancing its overdose protection program.
Key financial highlights include a cash position of $2.2 million as of June 30, 2025, receipt of a $5.3 million NIDA grant installment, and R&D expenses of $1.9 million. The company reported a net loss of $1.7 million for Q2 2025, an improvement from the $2.0 million loss in Q2 2024.
The company's pipeline includes PF614 (TAAP鈩� technology) and PF614-MPAR (combining TAAP鈩� and MPAR庐 technologies), both designed to provide safer opioid therapies. Ensysce also advanced its OUD program with PF9001 as the lead candidate for opioid use disorder treatment.
Ensysce Biosciences (NASDAQ:ENSC) ha registrato importanti progressi nel secondo trimestre 2025 nei suoi programmi innovativi per le terapie oppioidi. L'azienda ha avviato uno studio pivot di Fase 3 per PF614, il suo candidato principale per il dolore severo con deterrenza all'abuso integrata. Inoltre, Ensysce ha completato il reclutamento per la Parte 2 dello studio PF614-MPAR-102, facendo avanzare il programma di protezione dalle overdose.
Punti finanziari chiave: posizione di cassa di $2.2 milioni al 30 giugno 2025, ricezione di una tranche di sovvenzione NIDA da $5.3 milioni e costi di R&S pari a $1.9 milioni. La societ脿 ha riportato una perdita netta di $1.7 milioni nel Q2 2025, un miglioramento rispetto alla perdita di $2.0 milioni nel Q2 2024.
La pipeline include PF614 (tecnologia TAAP鈩�) e PF614-MPAR (combinazione delle tecnologie TAAP鈩� e MPAR庐), entrambe progettate per offrire terapie oppioidi pi霉 sicure. Ensysce ha inoltre avanzato il programma per il disturbo da uso di oppioidi con PF9001 come candidato principale per il trattamento dell'OUD.
Ensysce Biosciences (NASDAQ:ENSC) inform贸 avances significativos en el 2T 2025 en sus programas innovadores de terapias con opioides. La compa帽铆a inici贸 un ensayo pivotal de Fase 3 para PF614, su candidato principal para dolor severo con disuasi贸n de abuso integrada. Adem谩s, Ensysce complet贸 la inscripci贸n de la Parte 2 del estudio PF614-MPAR-102, impulsando su programa de protecci贸n contra sobredosis.
Aspectos financieros clave: posici贸n de efectivo de $2.2 millones al 30 de junio de 2025, recepci贸n de una tranche de subvenci贸n NIDA por $5.3 millones y gastos de I+D de $1.9 millones. La compa帽铆a report贸 una p茅rdida neta de $1.7 millones en el 2T 2025, una mejora frente a la p茅rdida de $2.0 millones en el 2T 2024.
La cartera incluye PF614 (tecnolog铆a TAAP鈩�) y PF614-MPAR (combinando las tecnolog铆as TAAP鈩� y MPAR庐), ambas dise帽adas para ofrecer terapias con opioides m谩s seguras. Ensysce tambi茅n avanz贸 su programa para el trastorno por uso de opioides (OUD) con PF9001 como candidato principal para el tratamiento de este trastorno.
Ensysce Biosciences (NASDAQ:ENSC)電� 2025雲� 2攵勱赴 順侅嫚鞝侅澑 鞓ろ敿鞓れ澊霌� 旃橂 頂勲攴鸽灗鞐愳劀 欷戩殧頃� 歆勳爠鞚� 氤搓碃頄堨姷雼堧嫟. 須岇偓電� 雮毄 氚╈ 旮半姤鞚� 雮挫灔霅� 欷戩 韱奠 頉勲炒氍检鞚� PF614鞚� 欷戨寑頃� 3靸�(Phase 3) 鞁滍棙鞚� 鞁滌瀾頄堨姷雼堧嫟. 霕愴暅 Ensysce電� 瓿茧嫟氤奠毄 氤错樃 頂勲攴鸽灗鞚� 歆勳爠鞁滍偆旮� 鞙勴暣 PF614-MPAR-102 鞐瓣惮 2攵�鞚� 霌彪鞚� 鞕勲頄堨姷雼堧嫟.
欤检殧 鞛 頃橃澊霛检澊韸鸽電� 2025雲� 6鞗� 30鞚� 旮办 順勱笀 鞛旍暋 $2.2 million, $5.3 million 攴滊鞚� NIDA 氤挫“旮� 韸鸽灉旃� 靾橂牴, 鞐瓣惮臧滊皽牍� $1.9 million 霌膘澊 鞛堨姷雼堧嫟. 須岇偓電� 2025雲� 2攵勱赴鞐� $1.7 million鞚� 靾滌啇鞁�鞚� 氤搓碃頄堨溂氅�, 鞚措姅 2024雲� 2攵勱赴鞚� $2.0 million 靻愳嫟氤措嫟 臧滌劆霅� 靾橃箻鞛呺媹雼�.
韺岇澊頂勲澕鞚胳棎電� PF614(TAAP鈩� 旮办垹) 氚� TAAP鈩㈧檧 MPAR庐 旮办垹鞚� 瓴绊暕頃� PF614-MPAR臧� 韽暔霅橃柎 鞛堨溂氅�, 氇憪 氤措嫟 鞎堨爠頃� 鞓ろ敿鞓れ澊霌� 旃橂毳� 鞝滉车頃橂弰搿� 靹り硠霅橃棃鞀惦媹雼�. Ensysce電� 霕愴暅 鞓ろ敿鞓れ澊霌� 靷毄 鞛レ暊(OUD) 旃橂毳� 鞙勴暅 靹犽弰 頉勲炒鞚� PF9001搿� OUD 頂勲攴鸽灗鞚� 歆勳爠鞁滌及鞀惦媹雼�.
Ensysce Biosciences (NASDAQ:ENSC) a annonc茅 des progr猫s significatifs au T2 2025 pour ses programmes innovants de traitement des opio茂des. La soci茅t茅 a lanc茅 un essai pivot de phase 3 pour PF614, son candidat principal pour la douleur s茅v猫re avec dissuasion int茅gr茅e contre l'abus. De plus, Ensysce a achev茅 le recrutement de la Partie 2 de l'茅tude PF614-MPAR-102, faisant progresser son programme de protection contre les surdoses.
Faits financiers cl茅s : position de tr茅sorerie de $2.2 millions au 30 juin 2025, r茅ception d'une tranche de subvention NIDA de $5.3 millions et d茅penses de R&D de $1.9 millions. La soci茅t茅 a enregistr茅 une perte nette de $1.7 millions au T2 2025, une am茅lioration par rapport 脿 la perte de $2.0 millions au T2 2024.
Le portefeuille comprend PF614 (technologie TAAP鈩�) et PF614-MPAR (combinaison des technologies TAAP鈩� et MPAR庐), toutes deux con莽ues pour offrir des th茅rapies opio茂des plus s没res. Ensysce a 茅galement avanc茅 son programme OUD avec PF9001 comme candidat principal pour le traitement du trouble li茅 脿 l'utilisation d'opio茂des.
Ensysce Biosciences (NASDAQ:ENSC) meldete im 2. Quartal 2025 deutliche Fortschritte bei seinen innovativen Opioid-Therapieprogrammen. Das Unternehmen startete eine wegweisende Phase-3-Studie f眉r PF614, den f眉hrenden Kandidaten gegen starke Schmerzen mit integriertem Missbrauchsschutz. Au脽erdem schloss Ensysce die Rekrutierung f眉r Teil 2 der PF614-MPAR-102-Studie ab und damit sein Programm zum Schutz vor 脺berdosierungen voran.
Wesentliche finanzielle Kennzahlen: Barbestand von $2.2 Millionen zum 30. Juni 2025, Erhalt einer $5.3 Millionen Tranche des NIDA-Zuschusses und F&E-Aufwendungen von $1.9 Millionen. Das Unternehmen verzeichnete im 2. Quartal 2025 einen Nettoverlust von $1.7 Millionen, eine Verbesserung gegen眉ber dem Verlust von $2.0 Millionen im 2. Quartal 2024.
Die Pipeline umfasst PF614 (TAAP鈩�-Technologie) und PF614-MPAR (Kombination aus TAAP鈩�- und MPAR庐-Technologien), die beide auf sicherere Opioid-Therapien abzielen. Ensysce brachte zudem sein OUD-Programm mit PF9001 als f眉hrendem Kandidaten zur Behandlung von Opioid-Gebrauchsst枚rungen voran.
- None.
- Cash position decreased to $2.2M from $3.5M in December 2024
- R&D expenses increased to $1.9M from $0.9M year-over-year
- Company expects continued losses for the foreseeable future
Insights
Ensysce's Q2 shows major advancement with PF614 Phase 3 launch and MPAR program progression, despite continued financial losses typical of clinical-stage development.
Ensysce has reached a significant inflection point with the initiation of its pivotal Phase 3 trial for PF614, its lead abuse-deterrent opioid candidate. This represents the final clinical hurdle before potential regulatory submission, significantly de-risking their development pathway. The trial focuses on post-surgical abdominoplasty pain, a well-established model for demonstrating analgesic efficacy that should provide clear efficacy signals.
The company's dual-technology approach continues to advance, with their TAAP鈩� technology (making oxycodone inactive until activated by intestinal enzymes) moving into late-stage development, while their MPAR庐 technology (providing overdose protection) shows continued progress with full enrollment completed in Part 2 of the PF614-MPAR-102 study. The FDA's prior Breakthrough Therapy designation for PF614-MPAR confirms the regulatory recognition of this program's potential significance.
Financial support through the $5.3 million NIDA installment (part of a larger $15 million grant) provides critical non-dilutive funding to advance the MPAR program through May 2026, though the cash position of $2.2 million (down from $3.5 million at year-end 2024) indicates continuing cash burn that will likely necessitate additional financing in the near term.
R&D expenses increased to $1.9 million (up from $0.9 million year-over-year), reflecting intensified clinical and preclinical activities. The net loss of $1.7 million represents a slight improvement from the $2.0 million loss in Q2 2024, though continued losses are expected throughout the clinical development phase.
The strategic expansion into opioid use disorder (OUD) treatments with their PF9001 candidate broadens their potential market beyond pain management, creating multiple potential commercialization pathways and strengthening their intellectual property portfolio with newly allowed patents.
Initiates Critical Milestone, Launching Phase 3 Trial of PF614 to Advance Next-Generation Opioid Therapy Toward Regulatory Approval
Receives
Accelerates PF614-MPAR-102 Study with Full Enrollment of Part 2
SAN 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.
Dr. 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."
Dr. 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."
"With 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鈩�, MPAR庐, 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.
TAAPTM (Opioid Abuse Deterrent Program) Update
The 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 analgesia.
In 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.
MPAR庐 (Opioid Abuse Deterrent and Overdose Protection Program) Update
PF614-MPAR is a combination product of the TAAPTM and MPAR庐 (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庐 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.
During 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鈩� and MPAR庐 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.
OUD Program Update
In 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鈩� and MPAR庐 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 the OUD space.
Q2 2025 Financial Results
Cash - Cash and cash equivalents were
Federal Grants - Funding under federal grants totaled
Research & Development Expenses - R&D expenses were
General & Administrative Expenses - G&A expenses were constant at
Other Income (Expense) - Total other income (expense) was income of
Net Income (Loss) - Net loss attributable to common stockholders for the second quarter of 2025 was
鹿The research is supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number UO1DA059791.
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鈩�) and Multi-Pill Abuse Resistance (MPAR庐) 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 .
Definitions
TAAP鈩�: trypsin activated abuse protection - designed to protect against prescription drug abuse.
MPAR庐: multi-pill abuse resistance - designed to protect against abuse and accidental overdose.
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
[email protected]
Ensysce Biosciences, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||||||
Federal grants | $ | 1,371,438 | $ | 181,797 | $ | 2,691,210 | $ | 487,519 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 1,923,430 | 947,229 | 3,808,957 | 1,726,133 | ||||||||||||
General and administrative | 1,198,523 | 1,190,010 | 2,600,279 | 2,559,791 | ||||||||||||
Total operating expenses | 3,121,953 | 2,137,239 | 6,409,236 | 4,285,924 | ||||||||||||
Loss from operations | (1,750,515 | ) | (1,955,442 | ) | (3,718,026 | ) | (3,798,405 | ) | ||||||||
Total other income (expense), net | 16,998 | (12,351 | ) | 38,936 | (1,285,951 | ) | ||||||||||
Net loss | $ | (1,733,517 | ) | $ | (1,967,793 | ) | $ | (3,679,090 | ) | $ | (5,084,356 | ) | ||||
Net loss attributable to noncontrolling interest and deemed dividend related to warrants down round provision | 166 | - | 166 | (216 | ) | |||||||||||
Net loss attributable to common stockholders | $ | (1,733,351 | ) | $ | (1,967,793 | ) | $ | (3,678,924 | ) | $ | (5,084,572 | ) | ||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.79 | ) | $ | (3.35 | ) | $ | (2.04 | ) | $ | (9.98 | ) | ||||
Ensysce Biosciences, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
Six Months Ended June 30, | ||||||||
2025 | 2024 | |||||||
Net cash used in operating activities | $ | (4,414,280 | ) | $ | (5,718,294 | ) | ||
Net cash provided by financing activities | 3,123,778 | 5,637,921 | ||||||
Change in cash and cash equivalents | (1,290,502 | ) | (80,373 | ) | ||||
Cash and cash equivalents at beginning of period | 3,502,077 | 1,123,604 | ||||||
Cash and cash equivalents at end of period | $ | 2,211,575 | $ | 1,043,231 | ||||
Ensysce Biosciences, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
June 30, | December 31, | |||||||
2025 | 2024 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 2,211,575 | $ | 3,502,077 | ||||
Prepaid expenses, unbilled receivable and other current assets | 3,070,020 | 1,842,605 | ||||||
Total current assets | 5,281,595 | 5,344,682 | ||||||
Other assets | 292,860 | 252,550 | ||||||
Total assets | $ | 5,574,455 | $ | 5,597,232 | ||||
Liabilities and stockholders' equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,042,832 | $ | 1,357,079 | ||||
Accrued expenses and other liabilities | 1,045,657 | 548,458 | ||||||
Notes payable and accrued interest | 424,521 | 301,660 | ||||||
Total current liabilities | 2,513,010 | 2,207,197 | ||||||
Long-term liabilities | 1,033 | 10,096 | ||||||
Total liabilities | 2,514,043 | 2,217,293 | ||||||
Stockholders' equity | 3,060,412 | 3,379,939 | ||||||
Total liabilities and stockholders' equity | $ | 5,574,455 | $ | 5,597,232 | ||||
SOURCE: Ensysce Biosciences
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FAQ
What major milestones did Ensysce Biosciences (ENSC) achieve in Q2 2025?
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What is the difference between PF614 and PF614-MPAR?
