Ensysce Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results
Rhea-AI Summary
Ensysce Biosciences (NASDAQ:ENSC) reported 2025 operational progress and year-end financials on March 30, 2026. Key clinical milestones include initiation of the PF614 Phase 3 (PF614-301) trial and continued development of PF614-MPAR under Breakthrough Therapy designation. The company received FDA feedback supporting overdose-protection labeling and a streamlined 505(b)(2) pathway.
Financials: cash $4.3M, federal grant funding $5.1M for 2025, R&D $10.4M (up $3.2M YoY), and net loss $10.2M for 2025. U.S. patent allowance extends MPAR protection through 2042.
Positive
- PF614 Phase 3 initiated (PF614-301 enrollment began Dec 2025)
- PF614-MPAR retains FDA Breakthrough Therapy designation
- FDA supported pursuit of overdose-protection labeling and 505(b)(2) pathway
- U.S. patent allowed extending MPAR protection through 2042
- Federal grant funding totaled $5.1M in 2025
Negative
- Net loss increased to $10.2M in 2025 (from $8.0M)
- R&D spend rose to $10.4M (+$3.2M YoY)
- Cash balance at year-end was $4.3M
- Cash used in operations totaled $7.8M in 2025
Key Figures
Market Reality Check
Peers on Argus
ENSC is down 3.56% while momentum peers show mixed action: PMCB down 3.81%, ADIL down 2.92%, and ARTL up 4.81%. The scanner notes a broader move (median about -3.4%) across the group, suggesting sector dynamics alongside ENSC’s company-specific earnings.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 14 | Q3 2025 earnings | Positive | -4.8% | Reported Q3 2025 results plus Phase 3 PF614-301 initiation and financing update. |
| Aug 13 | Q2 2025 earnings | Positive | -4.2% | Q2 2025 results with PF614 Phase 3 start, PF614-MPAR study progress, and NIDA grant. |
| May 13 | Q1 2025 earnings | Positive | +11.6% | Q1 2025 results, PF9001 patent grant, MPAR overdose protection data, higher grants. |
| Mar 10 | FY 2024 earnings | Positive | -4.8% | Q4/FY 2024 results plus strategic PF614 and PF614-MPAR partnership and grant growth. |
| Nov 12 | Q3 2024 earnings | Positive | +5.1% | Q3 2024 results with $14M NIH grant, PF614 Phase 3 protocol submission, improved cash. |
Earnings releases often highlight clinical and grant progress but have produced mixed stock reactions, with several negative moves despite ostensibly constructive updates.
Across the last five earnings-tagged releases from Nov 2024 through Nov 2025, Ensysce consistently paired financial updates with pipeline milestones such as PF614 Phase 3 initiation, PF614‑MPAR Breakthrough Therapy support, and new patents for PF9001. Cash balances fluctuated in the low single‑digit millions, supplemented by grants and preferred stock financings. Price reactions were modest, with both positive and negative moves, indicating that earnings and operational progress have not produced a consistently favorable trading pattern.
Historical Comparison
Over the past year, Ensysce released five earnings updates with an average move of 0.58%. Today’s -3.56% reaction is somewhat larger than typical but still within the historical range of modest, mixed responses.
Earnings updates have documented steady advancement of PF614 into Phase 3, PF614‑MPAR under Breakthrough Therapy designation, and expansion of OUD candidate PF9001, supported by grants and periodic financings.
Market Pulse Summary
This announcement combines Q4/FY 2025 financials with notable pipeline momentum: PF614 progressing in Phase 3, PF614‑MPAR advancing under Breakthrough Therapy designation, and PF9001 chosen for OUD. Investors may focus on the year-end cash balance of $4.3M versus a $10.2M net loss and $7.8M operating cash use, alongside continued reliance on federal grants. Future updates on Phase 3 data, OUD development, and additional funding steps remain key watchpoints.
Key Terms
phase 3 medical
breakthrough therapy designation regulatory
505(b)(2) regulatory
opioid use disorder (oud) medical
AI-generated analysis. Not financial advice.
~ Fourth Quarter Highlighted by Clinical and Regulatory Milestones Positioning PF614 for Late-Stage Advancement ~
SAN DIEGO, CA / ACCESS Newswire / March 30, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for novel therapeutics while reducing the potential for abuse and overdose, today reported financial and operational results for the fourth quarter and full year ended December 31, 2025.
"2025 was a year of meaningful progress for Ensysce, marked by significant clinical advancement, productive regulatory engagement, and continued strengthening of our intellectual property portfolio," said Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce Biosciences. "We initiated our Phase 3 trial for PF614 and had constructive dialogue with the FDA supporting our manufacturing pathway."
Dr. Kirkpatrick continued, "Enrollment in the PF614-301 Phase 3 study has progressed rapidly, while PF614-MPAR remains on an accelerated development path under Breakthrough Therapy designation. In parallel, we have advanced commercial manufacturing readiness for PF614 and have generated additional data supporting overdose-protection labeling for our MPAR platform. Beyond our late-stage programs, we strengthened the long-term value of our technology platforms through expanded patent protection and pipeline growth, including the advancement of PF9001 for opioid use disorder (OUD) and leveraging our TAAP™ and MPAR® technologies for additional indications such as attention deficit hyperactivity disorder (ADHD)."
Program Updates
TAAPTM (Opioid Abuse Deterrent) Program Update
Ensysce's lead drug candidate, PF614, is a Trypsin-Activated Abuse Protection (TAAPTM) extended-release oxycodone designed to deliver effective pain relief while incorporating built-in abuse protection. Through proprietary chemical modification of oxycodone, PF614 remains pharmacologically inactive until swallowed and exposed to trypsin in the small intestine, where it is activated to release oxycodone. This mechanism is designed to preserve therapeutic efficacy while significantly reducing the potential for tampering and abuse.
In December 2025, Ensysce announced the enrollment of the first patient in its pivotal Phase 3 clinical trial (PF614-301) evaluating PF614 for the treatment of moderate-to-severe post-surgical pain following abdominoplasty. The multicenter, randomized, double-blind, placebo-controlled study is designed to assess whether PF614 can deliver potent and consistent analgesia while leveraging its unique chemical design to mitigate the risk of opioid misuse. Clinical sites currently enrolling patients include CenExel JBR in Salt Lake City, Utah, and CenExcel Atlanta under experienced principal investigators in anesthesiology and pain medicine. Enrollment in PF614-301 represents a major milestone in Ensysce's strategy to introduce a next generation of safer opioid medicines and advance PF614 toward regulatory submission and potential commercialization.
MPAR® (Opioid Abuse Deterrent and Overdose Protection) Program Update
PF614-MPAR combines Ensysce's TAAP™ chemistry with its proprietary MPAR® (Multi-Pill Abuse Resistance) overdose-protection technology, designed to actively limit opioid release when multiple pills are consumed beyond prescribed doses. PF614-MPAR incorporates a trypsin inhibitor that automatically reduces opioid activation in overdose situations, effectively acting as a chemical "off-switch." Clinical data from the PF614-MPAR-101 study demonstrated that the MPAR® technology functioned as designed, providing overdose protection at a 25 mg dose. These results supported the FDA's Breakthrough Therapy designation granted in January 2024.
In November 2025, the FDA provided encouraging feedback regarding the development pathway for PF614-MPAR, including support for pursuing overdose-protection labeling and the potential use of a streamlined 505(b)(2) regulatory pathway, which could accelerate development and market entry. The FDA and Ensysce are collaborating on a framework to define and communicate the safety benefits of overdose-protection opioids, including development of a scientific whitepaper on overdose protection. This milestone, backed by multi-year grants from the National Institute on Drug Abuse (NIDA), marks a significant step toward transforming opioid safety and redefining pain management.
Opioid Use Disorder (OUD) Program Update
In addition to its pain management portfolio, Ensysce is developing treatments for opioid use disorder (OUD) designed to reduce cravings and relapse risk while maintaining patient safety and quality of life. The Company selected PF9001 as its lead OUD candidate and is evaluating the compound as a potential next-generation methadone alternative with built-in overdose protection, reduced cardiovascular risk and an oral delivery profile. This program was supported by a multi-year HEAL (Helping to End Addiction Long-Term) grant and in collaboration with NIDA.
Intellectual Property Expansion
In December 2025, the U.S. Patent and Trademark Office allowed a new patent covering Ensysce's MPAR® technology, further strengthening the Company's intellectual property protection through 2042. 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.
Ensysce is also exploring the application of MPAR technology beyond opioids, including potential programs in amphetamines for ADHD and methadone for OUD. In early January, Ensysce announced that the European Patent Office provided Notice of Allowance in December 2025, for the issuance of a Patent 'Compositions Comprising Enzyme-Cleavable Amphetamine Prodrugs and Inhibitors Thereof' for PF8026 protected by the TAAPTM and MPAR® technologies. These two issuances expand the potential reach of Ensysce's platforms across multiple therapeutic areas where abuse and overdose risk remain significant clinical challenges.
Fourth Quarter and Full Year 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
Other Income (Expense) - Total other income (expense) was income of
Net Income (Loss) - Net loss attributable to common stockholders for the fourth quarter of 2025 was
About Ensysce Biosciences
Ensysce Biosciences is a clinical-stage pharmaceutical company dedicated to disrupting the analgesic landscape through the development of a new class of safer opioid medicines for the treatment of severe pain. Leveraging its proprietary Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®) platforms, Ensysce is advancing tamper-resistant therapeutic options designed to minimize the risk of opioid abuse and oral overdose while preserving strong analgesic efficacy. For more information, visit www.ensysce.com.
Definitions
TAAP™: trypsin activated abuse protection - designed to protect against prescription drug abuse.
MPAR®: 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, 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; 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 annual report on Form 10-K and current reports on Form 8-K, which are 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
Ensysce Biosciences, Inc.
Condensed Consolidated Statements of Operations
2021 | 2020 | 2021 | 2020 | |||||||||||||
Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||||||
Federal grants | $ | 1,882,336 | $ | 1,303,659 | $ | 5,066,650 | $ | 5,210,031 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 3,613,029 | 3,802,630 | 10,376,895 | 7,219,437 | ||||||||||||
General and administrative | 1,051,132 | 1,077,505 | 4,930,701 | 4,720,728 | ||||||||||||
Total operating expenses | 4,664,161 | 4,880,135 | 15,307,596 | 11,940,165 | ||||||||||||
Loss from operations | (2,781,825 | ) | (3,576,476 | ) | (10,240,946 | ) | (6,730,134 | ) | ||||||||
Total other income (expense), net | 13,856 | 12,054 | 64,759 | (1,256,875 | ) | |||||||||||
Net loss | $ | (2,767,969 | ) | $ | (3,564,422 | ) | $ | (10,176,187 | ) | $ | (7,987,009 | ) | ||||
Adjustments to net loss | 321 | - | 487 | (216 | ) | |||||||||||
Net loss attributable to common stockholders | $ | (2,767,648 | ) | $ | (3,564,422 | ) | $ | (10,175,700 | ) | $ | (7,987,225 | ) | ||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.75 | ) | $ | (2.90 | ) | $ | (3.98 | ) | $ | (11.45 | ) | ||||
Ensysce Biosciences, Inc.
Condensed Consolidated Statements of Cash Flows
2021 | 2020 | |||||||
Year Ended December 31, | ||||||||
2025 | 2024 | |||||||
Net cash used in operating activities | $ | (7,806,292 | ) | $ | (7,502,700 | ) | ||
Net cash used in investing activities | (123,643 | ) | - | |||||
Net cash provided by financing activities | 8,738,212 | 9,881,173 | ||||||
Change in cash and cash equivalents | 808,277 | 2,378,473 | ||||||
Cash and cash equivalents at beginning of period | 3,502,077 | 1,123,604 | ||||||
Cash and cash equivalents at end of period | $ | 4,310,354 | $ | 3,502,077 | ||||
Ensysce Biosciences, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
December 31, | December 31, | |||||||
2025 | 2024 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 4,310,354 | $ | 3,502,077 | ||||
Prepaid expenses and other current assets | 2,932,114 | 1,842,605 | ||||||
Total current assets | 7,242,468 | 5,344,682 | ||||||
Property and equipment, net and other assets | 210,011 | 252,550 | ||||||
Total assets | $ | 7,452,479 | $ | 5,597,232 | ||||
Liabilities and stockholders' equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 3,267,610 | $ | 1,357,079 | ||||
Accrued expenses and other liabilities | 993,411 | 548,458 | ||||||
Notes payable and accrued interest | 306,708 | 301,660 | ||||||
Total current liabilities | 4,567,729 | 2,207,197 | ||||||
Long-term liabilities | - | 10,096 | ||||||
Total liabilities | 4,567,729 | 2,217,293 | ||||||
Stockholders' equity | 2,884,750 | 3,379,939 | ||||||
Total liabilities and stockholders' equity | $ | 7,452,479 | $ | 5,597,232 | ||||
SOURCE: Ensysce Biosciences, Inc.
View the original press release on ACCESS Newswire
FAQ
What milestone did Ensysce (ENSC) announce on March 30, 2026 about PF614?
What does Breakthrough Therapy status mean for PF614-MPAR and ENSC's development timeline?
How did Ensysce (ENSC) perform financially in 2025 regarding cash and net loss?
What intellectual property progress did Ensysce (ENSC) report for MPAR technology in 2025?
How much federal grant funding did Ensysce (ENSC) receive in 2025 and what programs did it support?
