Ensysce Biosciences Inc (ENSC)

Ensysce Biosciences Reports First Quarter 2026 Financial ResultsMay 15, 2026 4:15 PM
ACCESS Newswire~ 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 ~SAN DIEGO, CA / ACCESS Newswire / 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."The 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."Dr. 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."TAAP™ (Opioid Abuse Deterrent Program) UpdatePF614 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.This 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.In 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.MPAR® (Opioid Abuse Deterrent and Overdose Protection Program) UpdatePF614-MPAR is the Company's next-generation combination product that integrates both the TAAP™ 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 with severe pain.Initial 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 safety.In 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.Following 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.ADHD Program UpdateEnsysce 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.Opioid Use Disorder (OUD) Program UpdateBeyond 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.Q1 2026 Financial ResultsCash - 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.Federal 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 grant.Research & 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.General & 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.Net 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.About Ensysce BiosciencesEnsysce 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.DefinitionsTAAP™: 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 StatementsStatements 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 annual report on Form 10-K 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) 263-4196Ensysce Biosciences Investor Relations Contact:Shannon Devine
MZ North America
Main: 203-741-8811
ENSC@mzgroup.usEnsysce Biosciences, Inc.
Condensed Consolidated Statements of Operations
(Unaudited) Three Months Ended March 31, 2026 2025 Federal grants $960,999 $1,319,772 Operating expenses: Research and development 3,346,881 1,885,528 General and administrative 1,176,348 1,401,756 Total operating expenses 4,523,229 3,287,284 Loss from operations (3,562,230) (1,967,512)Total other income (expense), net 5,815 21,939 Net loss $(3,556,415) $(1,945,573)Net loss per share, basic and diluted $(0.52) $(1.39)Ensysce Biosciences, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited) Three Months Ended March 31, 2026 2025 Net cash used in operating activities $(3,500,925) $(1,707,412)Net cash (used in) provided by financing activities (63,947) 1,257,826 Change in cash and cash equivalents (3,564,872) (449,586)Cash and cash equivalents at beginning of period 4,310,354 3,502,077 Cash and cash equivalents at end of period $745,482 $3,052,491 Ensysce Biosciences, Inc.
Condensed Consolidated Balance Sheets
(Unaudited) March 31, December 31, 2026 2025
Assets Current assets: Cash and cash equivalents $745,482 $4,310,354 Prepaid expenses and other current assets 1,263,058 2,934,664 Total current assets 2,008,540 7,245,018 Other assets 159,263 207,461 Total assets $2,167,803 $7,452,479 Liabilities and stockholders' equity (deficit) Current liabilities: Accounts payable $1,610,186 $3,267,610 Accrued expenses and other liabilities 980,780 993,411 Notes payable and accrued interest 245,849 306,708 Total current liabilities 2,836,815 4,567,729 Long-term liabilities - - Total liabilities 2,836,815 4,567,729 Stockholders' equity (deficit) (669,012) 2,884,750 Total liabilities and stockholders' equity $2,167,803 $7,452,479 SOURCE: Ensysce BiosciencesView the original press release on ACCESS NewswireOriginal: Ensysce Biosciences Reports First Quarter 2026 Financial Results

Ensysce Biosciences Announces Expansion of Patent Protection for Groundbreaking MPAR(R) Overdose Protection TechnologyMay 12, 2026 8:00 AM
ACCESS Newswire~ Patent Extends Jurisdiction and Protection Through 2042 ~SAN DIEGO, CA / ACCESS Newswire / May 12, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering next-generation pain and central nervous system therapeutics designed to minimize abuse and overdose risk, today announced that the Taiwan Intellectual Property Office issued a patent covering Ensysce's MPAR® (Multi-Pill Abuse Resistance) technology. 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 that strengthen Ensysce's intellectual property estate for its unique overdose protection platform. The new issuance provides protection for the Company's MPAR® patent coverage through 2042 in this jurisdiction and expands the United States Patent No. 12,599,578 that issued on April 14, 2026.MPAR®, which has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), is engineered to reduce the impact of opioid exposure during an overdose. In clinical studies, PF614-MPAR provided effective pain relief when used as directed, while preventing excessive opioid release when multiple doses were taken. Ensysce has extended its MPAR® technology beyond opioids to other drug classes such as amphetamines and methadone to support the development of safer treatments for pain, ADHD, and opioid use disorder."MPAR® overdose protection, combined with our TAAP™ abuse-deterrent platform, offers a dual-layer safety approach that we believe is unmatched in the field," said Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce. "This new patent marks another step in our mission to make essential, proven medicines safer and we are grateful for the support and funding from the National Institute on Drug Abuse¹. This funding has enabled us to demonstrate clinically that MPAR moderates opioid release when taken in excess and is currently supporting our second clinical trial evaluating this technology. We remain committed to advancing PF614 and PF614-MPAR through late-stage clinical development to help reduce opioid abuse and overdose."¹Research supporting this patent was funded by the National Institute on Drug Abuse of the National Institutes of Health under Award Number DA047682.About Ensysce BiosciencesEnsysce 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 StatementsStatements 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 annual report on Form 10-K 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) 263-4196Ensysce Biosciences Investor Relations Contact:
Shannon Devine
MZ North America
Main: 203-741-8811
ENSC@mzgroup.usSOURCE: Ensysce Biosciences Inc.View the original press release on ACCESS NewswireOriginal: Ensysce Biosciences Announces Expansion of Patent Protection for Groundbreaking MPAR(R) Overdose Protection Technology

Ensysce Biosciences CEO Presents at Inaugural Clinical Pain Symposium in AmsterdamMay 8, 2026 8:00 AM
ACCESS Newswire~ Chemical Control, Clinical Confidence: Rethinking Opioids ~SAN DIEGO, CA / ACCESS Newswire / May 8, 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, announced that CEO, Dr. Lynn Kirkpatrick, presented as an invited speaker and was featured on a panel at the first Pain Therapeutics Summit Europe held in Amsterdam May 7-8, 2026.This meeting gathered experts from around the world to discuss latest advancements in analgesic care, including novel therapeutic candidates in development. Dr. Kirkpatrick's presentation on May 7th, titled "Chemical Control, Clinical Confidence: Rethinking Opioids," outlined a paradigm shift in opioid development-moving beyond traditional formulations to chemically engineered drugs with built-in safety controls.Her presentation focused on redefining the opioid benefit-risk equation through molecular design, while addressing the persistent gap between analgesic efficacy and safety. Dr. Kirkpatrick highlighted Ensysce's proprietary platforms:TAAP™ (Trypsin-Activated Abuse Protection): A unique prodrug platform designed to improve safety and reduce non-oral routes of misuse.MPAR® (Multi-Pill Abuse Resistance): A breakthrough technology engineered to provide overdose protection by creating a ceiling on drug plasma levels when excessive doses are taken."Opioids have always forced a tradeoff between efficacy and safety," said Dr. Kirkpatrick. "Our approach is fundamentally different. By embedding control directly into the drug itself, we believe we can preserve the analgesic power physicians rely on and patients need, while actively reducing the risks that have defined this class for decades."In addition to her presentation, Dr. Kirkpatrick participated in a panel of leading experts in the analgesic space to discuss "Safer Analgesics Without Losing Efficacy". The panel discussed key developments in the field that may lead to more effective pain products with better safety profiles. During the session, Dr. Kirkpatrick and the other experts discussed their clinical programs more fully and answered additional questions from the audience.About Ensysce BiosciencesEnsysce 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 StatementsStatements 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 annual report on Form 10-K 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) 263-4196Ensysce Biosciences Investor Relations Contact:
Shannon Devine
MZ North America
Main: 203-741-8811
ENSC@mzgroup.usSOURCE: Ensysce BiosciencesView the original press release on ACCESS NewswireOriginal: Ensysce Biosciences CEO Presents at Inaugural Clinical Pain Symposium in Amsterdam

Ensysce Biosciences Secures IRB Approval of Final Phase of PF614-MPAR-102 Clinical StudyApril 16, 2026 8:00 AM
ACCESS Newswire~ Advances First-in-Class Opioid with Oral Overdose-Protection ~SAN DIEGO, CA / ACCESS Newswire / April 16, 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 Investigational Review Board (IRB) approval to initiate Part 3 of the PF614-MPAR-102 clinical study, marking the final stage in this study evaluating its novel MPAR® (Multi-Pill Abuse Resistance) overdose-protection technology.PF614-MPAR, which received Breakthrough Therapy designation from the U.S. FDA following the PF614-MPAR-101 study, 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.Previously published clinical data demonstrate that PF614-MPAR delivers consistent, therapeutic plasma levels under normal dosing conditions, while significantly attenuating increases in opioid exposure at supratherapeutic doses. Part 3 of the PF614-MPAR-102 study is designed to further characterize this protective effect across a range of dosing scenarios.Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce stated "Nearly 80,000 lives are lost annually to opioid overdose in the U.S., with prescription opioids contributing meaningfully to this ongoing crisis1. MPAR® introduces a new class of chemically engineered opioids designed to actively protect patients, even in cases of dosing errors or misuse. This is a critical step toward establishing a new standard for opioid safety."The PF614-MPAR-102 study builds on earlier clinical findings and continues formulation development with ongoing support from the National Institute on Drug Abuse (NIDA)2.Beyond pain management, Ensysce is seeking to extend the uses of MPAR® across additional therapeutic categories including amphetamines and methadone, with the objective of delivering safer treatments for pain, attention-deficit/hyperactivity disorder (ADHD), and opioid use disorder.¹https://drugabusestatistics.org/opioid-epidemic/2Research supporting this patent was funded by the National Institute on Drug Abuse of the National Institutes of Health under Award Number DA047682.About Ensysce BiosciencesEnsysce 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 StatementsStatements 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 annual report on Form 10-K 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) 263-4196Ensysce Biosciences Investor Relations Contact:
Shannon Devine
MZ North America
Main: 203-741-8811
ENSC@mzgroup.usSOURCE: Ensysce BiosciencesView the original press release on ACCESS NewswireOriginal: Ensysce Biosciences Secures IRB Approval of Final Phase of PF614-MPAR-102 Clinical Study

Ensysce Biosciences Reports Fourth Quarter and Full Year 2025 Financial ResultsMarch 30, 2026 4:50 PM
ACCESS Newswire~ 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 UpdatesTAAPTM (Opioid Abuse Deterrent) Program UpdateEnsysce'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 UpdatePF614-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 UpdateIn 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 ExpansionIn 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 ResultsCash - Cash and cash equivalents were $4.3 million as of December 31, 2025, compared to $3.5 million as of December 31, 2024. Cash used in operating activities totaled $7.8 million in 2025 compared to $7.5 million in 2024.Federal Grants - Funding under federal grants totaled $1.9 million for the fourth quarter of 2025 compared to $1.3 million in the comparable year ago quarter. For the full year, funding from federal grants totaled $5.1 million in 2025, compared to $5.2 million in 2024. The differences are due to the timing of research activities eligible for funding under the OUD and MPAR grants, as decreases in funding under the OUD grant that ended in August 2024 were offset by increases in funding under the MPAR grant which began in September 2024.Research & Development Expenses - R&D expenses were $3.6 million for the fourth quarter of 2025 compared to $3.8 million for the same period in 2024. Research and development expenses were $10.4 million for the year ended December 31, 2025, compared to $7.2 million for the year ended December 31, 2024, respectively, representing an increase of $3.2 million. The increase was primarily the result of external research and development costs related to increased clinical and pre-clinical programs for PF614 and PF614-MPAR.General & Administrative Expenses - G&A expenses were $1.1 million in the fourth quarter of 2025, consistent with $1.1 million for the fourth quarter of 2024. For 2025, G&A expenses were $4.9 million, representing an increase of $0.2 million compared to $4.7 million for 2024.Other Income (Expense) - Total other income (expense) was income of $13,856 for the fourth quarter of 2025 compared to income of $12,054 in the same period of 2024. For 2025, total other income (expense), net was income of $64,759 compared to expense of $1.3 million for 2024. Other income and expense for the year ended December 31, 2025, consisted primarily of interest income from cash and cash equivalents. Other income and expense for the year ended December 31, 2024, consisted primarily of interest expense associated with the amortization of the original issue discount and the debt issuance costs associated with convertible notes issued in 2023.Net Income (Loss) - Net loss attributable to common stockholders for the fourth quarter of 2025 was $2.8 million compared to a net loss of $3.6 million for the fourth quarter of 2024. For 2025, net loss was $10.2 million compared to $8.0 million for 2024. 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.About Ensysce BiosciencesEnsysce 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.DefinitionsTAAP™: 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 StatementsStatements 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) 263-4196Ensysce Biosciences Investor Relations Contact:Shannon Devine
MZ North America
Main: 203-741-8811
ENSC@mzgroup.usEnsysce 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 NewswireOriginal: Ensysce Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results

ENSC....................................a/h

Ensysce Biosciences Initiates Live "Ask Me Anything" (AMA) Session Highlighting Growth and Future PlansMarch 4, 2026 8:45 AM
ACCESS Newswire~ Underscores Strategic Execution Plans, Regulatory Risk Mitigation Efforts, Pipeline Prioritization, and the Commercial Potential of PF614 ~SAN DIEGO, CALIFORNIA / ACCESS Newswire / March 4, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering next-generation pain and central nervous system therapeutics designed to minimize risk of abuse and overdose, today announced the successful initiation of its live "Ask Me Anything" (AMA) series on March 4, 2024.The event reinforced the Company's commitment to transparency, accessibility, and open dialogue with its community. A replay of the AMA series is available on the Company's website here.The AMA provided Ensysce shareholders and followers with the opportunity to engage directly with Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, covering topics such as Phase 3 execution and timeline visibility, capital discipline and shareholder alignment, as well as strategic priorities and long-term value creation. The event generated numerous distinct questions, arranged under 3 topics reflecting strong engagement and interest from the community."Our recent AMA session provided an important opportunity to engage directly with stakeholders and reinforce the strategic clarity behind our PF614 program," said Dr. Kirkpatrick. "We believe there is significant commercial potential for PF614 and that we are positioning the program to address unmet needs in the marketplace. We remain focused on disciplined execution and transparent communication as we advance these programs toward meaningful milestones."Key highlights from the AMA included:PF614-301 timeline sequencingEfforts to reduce clinical and regulatory uncertaintyPF614, PF614-MPAR & ADHD pipeline prioritizationPotential PF614 commercial opportunitiesFor those who were unable to have their questions answered, please reach out for future opportunities to investor relations at ENSC@mzgroup.us.About Ensysce BiosciencesEnsysce 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 StatementsStatements 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 quarterly report on Form 10-Q 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) 263-4196Ensysce Biosciences Investor Relations Contact:Shannon Devine
MZ North America
Main: 203-741-8811
ENSC@mzgroup.usSOURCE: Ensysce BiosciencesView the original press release on ACCESS NewswireOriginal: Ensysce Biosciences Initiates Live "Ask Me Anything" (AMA) Session Highlighting Growth and Future Plans

Found Early: $ENSC - Up 56% - #DDAmanda Chart

Don't miss the next one: https://DDAmanda.com



Z

Follow-Through Leaders: Production Ramps, AI Alliances, Balance Sheet Strength

Feb 27, 2026

Ensysce Biosciences: Strategic Review as a Catalyst Layer
Ensysce Biosciences (NASDAQ: ENSC) initiated a formal review of strategic alternatives aimed at enhancing shareholder value and advancing its TAAP™ and MPAR® platforms.

The review includes potential partnerships, licensing transactions, capital formation strategies, asset sales, or broader corporate combinations. While no timeline has been set, strategic reviews often introduce optionality into a stock’s narrative, particularly for clinical-stage companies with differentiated platforms.

Management emphasized disciplined execution while exploring ways to unlock value tied to its proprietary abuse-deterrent and overdose-protection technologies. In biotech, optionality itself can serve as a catalyst if meaningful partnerships or capital events materialize.

https://investorshub.advfn.com/stock-market/NASDAQ/ensysce-biosciences-ENSC/stock-news/97939471/follow-through-leaders-production-ramps-ai-allia

$ENSC 🗞️

ENSC..........................................https://stockcharts.com/sc3/ui/?s=ENSC&p=w&b=5&g=0&id=p86431144783

What's the news with this big POS scam, ENSC? 21M volume and counting. Same thing every time - I'd imagine another RS coming soon. More volume this time though.

ENSC........................................a/h

Ensysce Biosciences Receives EU Patent Expanding its First-in-Class ADHD Therapy with Built-In Abuse and Overdose Protection
~ New ADHD pipeline leverages TAAP™ and MPAR® technologies to improve safety for patients ~

SAN DIEGO, CALIFORNIA / ACCESS Newswire / January 8, 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 announced it received a Notice of Allowance from the European Patent Office for the issuance of a patent* for PF8026, a groundbreaking Attention-Deficit/Hyperactivity Disorder (ADHD) therapy. PF8026 is a novel immediate-release amphetamine prodrug protected by the Company's proprietary TAAP™ (Trypsin Activated Abuse Protection) and MPAR® (Multi-Pill Abuse Resistance) technologies.

This newly allowed patent, covering both composition of matter and method of use claims, adds to the Ensysce patent portfolio and secures its subject-matter authority in developing safer treatments for ADHD, a condition affecting millions of children and adults worldwide.

$1.37

Ensysce Biosciences Achieves Major Milestone with Initiation of Enrollment in Pivotal Phase 3 Trial of PF614, Its Next-Generation Opioid December
~ Engineered to Deliver Potent Pain Relief with Unique, Built-In, Abuse Protection
~ SAN DIEGO, CA / ACCESS Newswire / December 9, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering novel solutions for severe pain with built-in abuse and overdose protection, today announced that the first patient has been enrolled in the Company's pivotal Phase 3 clinical trial of PF614, its lead product candidate. This landmark study, PF614-301, ‘A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain after Abdominoplasty'," is designed to demonstrate PF614's ability to provide strong, consistent post-surgical pain relief while incorporating an innovative chemical mechanism intended to reduce the risk of abuse. The trial will also evaluate PF614's potential to provide a smoother, safer treatment of severe acute pain using twice daily dosing with reduced highs and lows in blood drug concentration, an approach which is seen as beneficial by leaders in the field. Enrollment has commenced at CenExel JBR in Salt Lake City, Utah, under the leadership of Dr. Todd Bertoch, and CenExcel Atlanta under the leadership of Dr. Jessica McCoun, both recognized expert in anesthesiology and pain medicine and the study's Principal Investigators. "This is a significant milestone for Ensysce and for the millions of patients who depend on opioid analgesia during recovery from serious surgery." said Dr. Lynn Kirkpatrick, CEO of Ensysce. "Initiation of our pivotal Phase 3 program moves us one step closer to redefining pain care. We aim to show that PF614 can reliably deliver the level of pain control patients need, while its built-in protective features help safeguard against the dangers of abuse. We believe PF614 represents a next ? generation of safety for opioid therapy and this Phase 3 trial marks a significant step on our pathway to commercialization."

FDA Response Streamlines Path to Commercial Production of PF614~

SAN DIEGO, CA / ACCESS Newswire / November 20, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering next-generation pain and central nervous system therapeutics designed to minimize abuse and overdose risk, today announced that the Food and Drug Administration (FDA or Agency) provided Written Responses to a meeting request.

Ensysce had requested guidance on its approach to the manufacture of PF614, wanting to understand the appropriateness of regulatory starting materials (RSMs) and specifications for PF614 drug substance and the RSMs.

In its written responses, the Agency agreed with all of Ensysce's proposed plans. These responses provide Ensysce with a direct path to commercial production of PF614, which is currently being initiated with its manufacturing partner, Purisys, LLC, a subsidiary of Noramco, LLC.

Dr. Jeff Millard, Chief Operating Officer of Ensysce who lead the CMC effort stated "We are extremely pleased with the FDA's feedback, which validates our approach and enables us to accelerate PF614's path to market. This milestone brings us closer to providing safer pain relief options for patients in need."

"The feedback from the FDA now provides us with a clear path to scaling our manufacture of PF614 for its commercial production," said Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce. "PF614 is our TAAP™ oxycodone analogue and the leading product in our Next Generation Analgesic pipeline of TAAP™ and MPAR® products. We are exceptionally pleased that our meeting package was so well received and that we are aligned with the FDA requirements for producing this novel therapeutic that is designed to alleviate moderate to severe pain while providing what we believe are safer qualities for the general public who require this level of pain relief."

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.

https://ir.ensysce.com/news/press-releases/detail/202/ensysce-biosciences-secures-4-million-financing-unlocking

PM spike...hopefully good news comes soon

ENSC................................................................p/m

$ENSC Ensysce Biosciences Q1 EPS $(1.39) Beats $(3.02) Estimate, Sales $1.32M Up From $305.72K YoY

ENSC reports Monday May 12 according to Seeking Alpha

If they execute properly $ENSC is a steal at $2 IMO

ENSC under $4

Ensysce Biosciences, Inc (NASDAQ:ENSC) stock gained almost 100% with a strong session volume compared to the average volume of 81.23K, as per data from Benzinga Pro.

Ensysce Biosciences on Wednesday 4/23 received a Notice of Allowance from the U.S. Patent and Trademark Office for the issuance of a patent entitled Enzyme-Cleavable Methadone Prodrugs and Methods of Use Thereof including both composition of matter and method of use claims.PF9001, the medication covered by this patent, is designed to provide a safer treatment option for opioid use disorder (OUD) by using Ensysce’s TAAP and MPAR abuse-deterrent and overdose protection technologies.

Nope. They're still firmly in control 

Volume is off the charts!

Nice pm move. I dont see any news so probably a nice short squeeze here. The shorts have controlled the trading here for a long time so hopefully this is the beginning of a change in long term direction.

ensc.............................................................p/m

ENSC, new 52 week low

ENSC, new 52 week low

ENSC.................................https://stockcharts.com/h-sc/ui?s=ENSC&p=W&b=5&g=0&id=p86431144783

Awesome news, don't be fooled by the MM tree shake after the nice premarket spike; good times are starting.

-$

https://ir.ensysce.com/news/press-releases/detail/180/ensysce-biosciences-announces-positive-interim-data-for

The good news we were anticipating.

https://finance.yahoo.com/news/ensc-continues-announce-potential-life-110600665.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuYmluZy5jb20v&guce_referrer_sig=AQAAAFtsmNC-EByKeQlVf7gg4DtBG1cmHV_YM3Y2nOqgEJ0TXStxvWdaennPH-WNC9uVGerYHWpmdvpEG6xQyMhFc80p_gYO_JjquKHxxV6mmxdVZ2U8cDGkDtqvIas0ooQhcy4KUCIA14ehuBib-oC4d6K61_oUPR6291lpXxiwNst5

Looking forward to a productive 2025

https://finance.yahoo.com/news/ensysce-biosciences-issues-annual-shareholder-130000054.html

Boom! Lets go!

Hey Glenn - when you send charts can you give sentiment? Good or Bad?

ENSC.....................https://stockcharts.com/h-sc/ui?s=ENSC&p=W&b=5&g=0&id=p86431144783

Interesting that this is holding up nicely after RS. I'm still bullish long term

And there it is. RS 1-15
https://ih.advfn.com/stock-market/NASDAQ/ensysce-biosciences-ENSC/stock-news/95028942/form-8-k-current-report
one-for-fifteen (1-for-15) reverse stock split (the “Reverse Stock Split”) of our common stock, par value $0.0001 (the “Common Stock”). The Reverse Stock Split will be effective as of 12:01 am on December 6, 2024 (the “Effective Time”).

RS coming. Not happy.

The stockholders approved an amendment to the Company’s Certificate of Incorporation to authorize the Company’s Board of Directors to combine outstanding shares of the Company’s common stock into a lesser number of outstanding shares, a “Reverse Stock Split,” by a ratio of not less than one-for-ten and not more than one-for-forty, with the exact ratio to be set within this range by the Board in its sole discretion:

TIme to climb back up in line with the 5yr chart.
LFG!

ENSC profile via Zacks --> Yahoo:

https://finance.yahoo.com/news/ensc-improves-position-100000760.html

"We encourage investors to take a look at ENSC and consider the stock before the anticipated positive testing results come in."

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ensc............................https://stockcharts.com/h-sc/ui?s=ensc&p=W&b=5&g=0&id=p86431144783

As of November 11, 2024, the registrant had 19,574,014 shares of common stock, $0.0001 par value per share, outstanding.

I'll get you an estimate on the float in a little bit...they turned a nice profit in the Q thanks to a gov grant...counted as revenue...

$ENSC

It’s nonsense. I’ll give it to the guy, he’s a good scalper and can hit tops on technical moves. But fundamentals…not so much.

There is no dilution because the warrants have been transferred (mostly from sabby) to a new owner who wants to convert them, but they are tied up until the shareholder meeting to vote on full conversion.

We’re seeing the effects of a chronically depressed market cap, bullish investors suddenly holding the warrants, and the loss of downward pressure due to the near-unlimited shorting collateral those warrants represented to Sabby. But dilution? Nope. There’s nothing available to dilute with.

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geez man you said that about WBUY and it nothing but go up.

Anyone know how many shares available, outstanding, float? I'm seeing conflicting info