Ensysce Biosciences Secures Patent Protection and Breakthrough Therapy Designation
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Mar 31 2025
0mins
Ensysce Biosciences Inc. shares rose by 10.42% as the stock crossed above its 5-day SMA, reflecting positive investor sentiment.
The company recently secured an extension of its MPAR® patent protection in Taiwan until 2042, enhancing its competitive edge in the market. Additionally, the FDA granted Breakthrough Therapy designation to its PF614-MPAR technology, which has shown promising results in clinical studies for pain relief while minimizing risks associated with excessive dosing. This recognition is expected to bolster investor confidence and support future growth initiatives.
The implications of these developments are significant for Ensysce, as the extended patent protection and FDA designation may lead to increased market opportunities and potential revenue growth, despite the challenges highlighted in their recent earnings report.
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Analyst Views on ENSC
About ENSC
Ensysce Biosciences, Inc. is a clinical-stage pharmaceutical company. The Company develops solutions for severe pain relief while reducing the potential for opioid misuse, abuse, and overdose. Its pipeline includes two new drug platforms: an abuse-resistant opioid prodrug technology, the Trypsin Activated Abuse Protection (TAAP) platform, and an over-dose protection opioid prodrug technology, the Multi-Pill Abuse Resistant (MPAR) platform. Its lead product, PF614, is a TAAP extended-release oxycodone and a potential analgesic to treat severe pain. Its second product, PF614-MPAR, is to treat severe pain with the added benefit of oral overdose protection, is a combination product of the TAAP prodrug PF614 with a trypsin inhibitor. Additionally, nafamostat, which is an ingredient in its overdose protection combination products, is also being developed for the intended purpose of treating infection and pulmonary lung diseases.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Ensyce Biosciences Expands MPAR Patent for Drug Abuse Prevention
- Patent Expansion: Ensyce Biosciences announced the expansion of its MPAR technology patent, approved by the USPTO, covering composition-of-matter and method-of-use for drug abuse prevention, securing market competitiveness until 2042.
- Clinical Study Results: PF614-MPAR demonstrated effective pain relief in clinical studies while preventing excessive opioid release with multiple doses, indicating its potential to significantly improve medication safety by reducing opioid abuse and overdose risks.
- FDA Fast Track Designation: The technology previously received FDA fast track designation, highlighting its importance and urgency in clinical development, which further boosts investor confidence in Ensyce's future prospects.
- Stock Price Fluctuation: Ensyce's stock closed up 13.17% at $0.32 on Monday but fell 8.52% to $0.29 in pre-market trading, reflecting mixed market reactions to the company's recent developments, which may impact investor sentiment.
See More
Ensysce Biosciences Q1 Earnings Report Analysis
- Earnings Performance: Ensysce Biosciences reported a Q1 GAAP EPS of -$0.52, beating expectations by $0.21, indicating improvements in cost management, although the overall financial health remains a concern.
- Federal Grant Status: The company received $0.96M in federal grants, a 27.3% year-over-year decline, missing expectations by $0.94M, reflecting insufficient external funding support that may hinder future R&D progress.
- Cash Flow Situation: As of March 31, 2026, cash and cash equivalents stood at $0.7M, significantly down from $4.3M on December 31, 2025, indicating increased liquidity risk and the need for measures to improve cash turnover.
- Financing Progress: On April 7, 2026, the company closed a second tranche of $2.0M in convertible preferred stock financing, part of a previously announced commitment for up to $20M over 24 months, aimed at strengthening its capital structure to support future business growth.
See More
Ensysce Secures Taiwan Patent Protection Through 2042
- Patent Protection Extended: Ensysce's MPAR® patent protection in Taiwan has been extended to 2042, strengthening its intellectual property in managing drug abuse and overdose risks, ensuring the uniqueness and competitiveness of its innovative technology in the market.
- Breakthrough Therapy Recognition: The MPAR® technology has received Breakthrough Therapy designation from the FDA, with clinical studies showing that PF614-MPAR effectively relieves pain while preventing excessive release during multiple dosing, enhancing patient safety in medication use.
- Multi-Drug Applicability: Ensysce has expanded its MPAR® technology to other drug classes such as amphetamines and methadone, aiming to develop safer treatment options to meet the needs for pain management, ADHD, and opioid use disorder.
- Clinical Trial Support: The research supporting this patent has been funded by the National Institute on Drug Abuse, facilitating Ensysce's second clinical trial to further validate the effectiveness of the MPAR® technology and advance PF614 and PF614-MPAR through late-stage clinical development.
See More
Ensysce Biosciences Q4 Earnings Beat Expectations
- Earnings Performance: Ensysce Biosciences reported a Q4 GAAP EPS of -$0.75, beating expectations by $0.51, indicating an improvement in financial performance despite remaining in a loss position.
- Cash Position: As of December 31, 2025, the company had cash and cash equivalents of $4.3 million, up from $3.5 million in 2024, suggesting progress in cash management.
- Operating Cash Usage: Cash used in operating activities totaled $7.8 million in 2025, slightly up from $7.5 million in 2024, reflecting ongoing pressure on operational expenditures.
- Future Outlook: Despite facing losses and cash flow challenges, Ensysce Biosciences' financial data indicates potential growth opportunities in the market, prompting investors to monitor subsequent strategic adjustments.
See More
Ensysce Biosciences Initiates Strategic Review to Enhance Shareholder Value
- Strategic Review Initiated: Ensysce Biosciences announced that its Board of Directors is exploring various strategic alternatives, including partnerships, licensing arrangements, or asset sales, aimed at enhancing shareholder value and advancing the company's technologies.
- Technological Platform Advantage: The company focuses on its proprietary TAAP and MPAR platforms, designed to fundamentally improve the safety profile of opioids, with CEO Lynn Kirkpatrick stating that these technologies have relevance beyond a single class of drugs.
- Significant Stock Price Increase: Following the announcement of the strategic review, Ensysce Biosciences' shares surged by 58.66% to $0.63, reflecting positive market sentiment regarding the company's future potential.
- Focus on Execution: Kirkpatrick emphasized that while exploring strategic options, the company will remain disciplined in its execution and continue to advance the TAAP and MPAR platforms to ensure long-term business growth and shareholder returns.
See More
Kraig Biocraft Laboratories Launches Production Plan
- Production Plan Launch: Kraig Biocraft Laboratories has confirmed that its 2026 production plan has transitioned from roadmap to execution, with the March production run marking the first wave of its multi-ton spider silk scale-up initiative, expected to achieve unprecedented commercial volumes, thereby enhancing the company's market competitiveness.
- Technology Showcase Boosts Visibility: The company's recombinant spider silk technology was featured on the cover of National Geographic, highlighting the scalability of its genetically enhanced silkworm platform and emphasizing its commercialization potential across medical, industrial, and defense sectors, further enhancing brand recognition in the market.
- Enterprise AI Partnership Acceleration: The strategic partnership between Rackspace and Palantir aims to deploy Palantir's Foundry and AI platform into production environments, with plans to scale Palantir-trained engineering teams from 30 to over 250 in the next 12 months, significantly improving operational efficiency for enterprises in regulated industries.
- Strategic Review Sparks Value Enhancement: Ensysce Biosciences has initiated a formal review of strategic alternatives aimed at enhancing shareholder value through potential partnerships and capital formation strategies, and while no timeline has been set, such reviews typically introduce more market opportunities for clinical-stage companies.
See More
Ensyce Biosciences Expands MPAR Patent for Drug Abuse Prevention
- Patent Expansion: Ensyce Biosciences announced the expansion of its MPAR technology patent, approved by the USPTO, covering composition-of-matter and method-of-use for drug abuse prevention, securing market competitiveness until 2042.
- Clinical Study Results: PF614-MPAR demonstrated effective pain relief in clinical studies while preventing excessive opioid release with multiple doses, indicating its potential to significantly improve medication safety by reducing opioid abuse and overdose risks.
- FDA Fast Track Designation: The technology previously received FDA fast track designation, highlighting its importance and urgency in clinical development, which further boosts investor confidence in Ensyce's future prospects.
- Stock Price Fluctuation: Ensyce's stock closed up 13.17% at $0.32 on Monday but fell 8.52% to $0.29 in pre-market trading, reflecting mixed market reactions to the company's recent developments, which may impact investor sentiment.
See More
Ensysce Biosciences Q1 Earnings Report Analysis
- Earnings Performance: Ensysce Biosciences reported a Q1 GAAP EPS of -$0.52, beating expectations by $0.21, indicating improvements in cost management, although the overall financial health remains a concern.
- Federal Grant Status: The company received $0.96M in federal grants, a 27.3% year-over-year decline, missing expectations by $0.94M, reflecting insufficient external funding support that may hinder future R&D progress.
- Cash Flow Situation: As of March 31, 2026, cash and cash equivalents stood at $0.7M, significantly down from $4.3M on December 31, 2025, indicating increased liquidity risk and the need for measures to improve cash turnover.
- Financing Progress: On April 7, 2026, the company closed a second tranche of $2.0M in convertible preferred stock financing, part of a previously announced commitment for up to $20M over 24 months, aimed at strengthening its capital structure to support future business growth.
See More
Ensysce Secures Taiwan Patent Protection Through 2042
- Patent Protection Extended: Ensysce's MPAR® patent protection in Taiwan has been extended to 2042, strengthening its intellectual property in managing drug abuse and overdose risks, ensuring the uniqueness and competitiveness of its innovative technology in the market.
- Breakthrough Therapy Recognition: The MPAR® technology has received Breakthrough Therapy designation from the FDA, with clinical studies showing that PF614-MPAR effectively relieves pain while preventing excessive release during multiple dosing, enhancing patient safety in medication use.
- Multi-Drug Applicability: Ensysce has expanded its MPAR® technology to other drug classes such as amphetamines and methadone, aiming to develop safer treatment options to meet the needs for pain management, ADHD, and opioid use disorder.
- Clinical Trial Support: The research supporting this patent has been funded by the National Institute on Drug Abuse, facilitating Ensysce's second clinical trial to further validate the effectiveness of the MPAR® technology and advance PF614 and PF614-MPAR through late-stage clinical development.
See More
Ensysce Biosciences Q4 Earnings Beat Expectations
- Earnings Performance: Ensysce Biosciences reported a Q4 GAAP EPS of -$0.75, beating expectations by $0.51, indicating an improvement in financial performance despite remaining in a loss position.
- Cash Position: As of December 31, 2025, the company had cash and cash equivalents of $4.3 million, up from $3.5 million in 2024, suggesting progress in cash management.
- Operating Cash Usage: Cash used in operating activities totaled $7.8 million in 2025, slightly up from $7.5 million in 2024, reflecting ongoing pressure on operational expenditures.
- Future Outlook: Despite facing losses and cash flow challenges, Ensysce Biosciences' financial data indicates potential growth opportunities in the market, prompting investors to monitor subsequent strategic adjustments.
See More
Ensysce Biosciences Initiates Strategic Review to Enhance Shareholder Value
- Strategic Review Initiated: Ensysce Biosciences announced that its Board of Directors is exploring various strategic alternatives, including partnerships, licensing arrangements, or asset sales, aimed at enhancing shareholder value and advancing the company's technologies.
- Technological Platform Advantage: The company focuses on its proprietary TAAP and MPAR platforms, designed to fundamentally improve the safety profile of opioids, with CEO Lynn Kirkpatrick stating that these technologies have relevance beyond a single class of drugs.
- Significant Stock Price Increase: Following the announcement of the strategic review, Ensysce Biosciences' shares surged by 58.66% to $0.63, reflecting positive market sentiment regarding the company's future potential.
- Focus on Execution: Kirkpatrick emphasized that while exploring strategic options, the company will remain disciplined in its execution and continue to advance the TAAP and MPAR platforms to ensure long-term business growth and shareholder returns.
See More
Kraig Biocraft Laboratories Launches Production Plan
- Production Plan Launch: Kraig Biocraft Laboratories has confirmed that its 2026 production plan has transitioned from roadmap to execution, with the March production run marking the first wave of its multi-ton spider silk scale-up initiative, expected to achieve unprecedented commercial volumes, thereby enhancing the company's market competitiveness.
- Technology Showcase Boosts Visibility: The company's recombinant spider silk technology was featured on the cover of National Geographic, highlighting the scalability of its genetically enhanced silkworm platform and emphasizing its commercialization potential across medical, industrial, and defense sectors, further enhancing brand recognition in the market.
- Enterprise AI Partnership Acceleration: The strategic partnership between Rackspace and Palantir aims to deploy Palantir's Foundry and AI platform into production environments, with plans to scale Palantir-trained engineering teams from 30 to over 250 in the next 12 months, significantly improving operational efficiency for enterprises in regulated industries.
- Strategic Review Sparks Value Enhancement: Ensysce Biosciences has initiated a formal review of strategic alternatives aimed at enhancing shareholder value through potential partnerships and capital formation strategies, and while no timeline has been set, such reviews typically introduce more market opportunities for clinical-stage companies.
See More
