Ensysce Biosciences Issues 2025 Annual Letter to Shareholders
Ensysce Biosciences issued its 2025 annual letter to shareholders from CEO Lynn Kirkpatrick, which read in part, "2025 was a year of meaningful execution and strategic advancement for Ensysce. I would like to thank our shareholders for your continued support as we advance our mission to deliver safer, more responsible opioid analgesics without compromising access to effective pain relief. Over the past year, we made substantial progress across clinical development, regulatory alignment, intellectual property, and financing- strongly positioning the Company for 2026 and beyond. Our efforts in 2025 were centered on advancing our clinical programs built on Ensysce's proprietary TAAP and MPAR technology platforms. Together, these platforms are designed to fundamentally improve the safety profile of opioid medications by addressing both abuse and overdose risk while preserving therapeutic efficacy...As we enter 2026, Ensysce is positioned for continued momentum. Key anticipated milestones include: Continued enrollment and execution of the PF614-301 Phase 3 trial Advancement of PF614-MPAR under Breakthrough Therapy designation Additional FDA interactions supporting commercial manufacturing readiness Further data generation to support overdose-protection labeling for MPAR products Advancement of PF9001 toward IND-enabling activities We remain committed to advancing the next generation of powerful analgesics that address the severest of pain while incorporating safeguards aligned with modern public health priorities."
Trade with 70% Backtested Accuracy
Analyst Views on ENSC
About ENSC
About the author
Ensysce Secures Brazilian Patent to Advance Safer Opioid Treatments
- Patent Approval: Ensysce received a Notice of Allowance from the Brazilian Patent Office for its TAAP™ and MPAR® technologies applied to additional opioid families, further strengthening its intellectual property and supporting the global development of safer analgesics.
- Technological Innovation: The application of MPAR® technology in Ensysce's opioids is expected to significantly reduce abuse potential and prevent overdose, enhancing patient safety without compromising pain relief, showcasing the transformative potential of its platforms.
- Market Expansion: This patent not only extends Ensysce's protection in North America and the EU but also strengthens its competitive position in the South American market, aiding the company's global strategy in the analgesic sector.
- Strategic Vision: Ensysce's CEO highlighted that this patent approval complements its recent patent for ADHD and opioid use disorder products, marking a significant step towards developing safer and more effective therapeutic options.
Ensysce Initiates PF614 Phase 3 Enrollment, Advancing Towards Commercialization
- Clinical Milestone: Ensysce Biosciences announced the enrollment of the first patient in the PF614 Phase 3 trial, marking a significant step towards commercialization and expected to enhance its competitive position in the safe opioid market.
- IP Expansion: The newly granted U.S. patent extends the protection for Ensysce's MPAR® overdose-prevention platform until 2042, strengthening the company's competitive moat in the field of safe opioid therapeutics.
- Regulatory Milestone: The FDA's endorsement of PF614's Chemistry, Manufacturing, and Controls strategy provides a clear pathway for commercial-scale production, reducing regulatory risks and enhancing the likelihood of successful approval.
- Capital Financing: Ensysce secured $4 million in convertible preferred stock financing, with the potential for an additional $16 million, significantly enhancing the company's financial flexibility as it advances the PF614 Phase 3 program.
Ensysce Initiates PF614 Phase 3 Enrollment, Advancing Towards Commercialization
- Clinical Milestone: Ensysce Biosciences announced the enrollment of the first patient in the PF614 Phase 3 study, marking a significant step towards commercialization, which is expected to enhance its competitiveness in the safer opioid market.
- IP Expansion: The newly granted U.S. patent extends the protection of Ensysce's MPAR® overdose-prevention platform until 2042, strengthening the company's competitive moat in opioid safety and supporting its future market positioning.
- FDA Regulatory Milestone: The FDA's agreement on PF614's Chemistry, Manufacturing, and Controls strategy provides a clear pathway to commercial production, reducing regulatory risks and enhancing Ensysce's competitiveness at key clinical and regulatory inflection points.
- Financing Strengthens Capital: Ensysce closed a $4 million convertible preferred stock financing, with potential access to an additional $16 million, significantly enhancing the company's financial flexibility to support PF614's Phase 3 development and other initiatives.
Ensysce Secures FDA Approval for PF614 Commercial Production Pathway
- Positive FDA Feedback: Ensysce Biosciences received written responses from the FDA confirming the appropriateness of its regulatory starting materials and specifications for PF614. This feedback provides Ensysce with a direct path to commercial production, marking a significant milestone in its drug development journey.
- Strengthened Partnerships: Ensysce is initiating commercial production of PF614 in collaboration with Purisys, LLC. This partnership will accelerate the market launch of the new analgesic, addressing the growing demand for safer pain relief options.
- Innovative Product Outlook: PF614 is Ensysce's TAAP™ oxycodone analogue and the leading product in its next-generation analgesic pipeline. Designed to provide safer pain relief while minimizing the risk of abuse and overdose, it holds significant market potential.
- Increased Executive Confidence: Ensysce CEO Dr. Lynn Kirkpatrick stated that the FDA's feedback enables the company to expedite PF614's market pathway, further solidifying its leadership in the analgesic market. This progress will help improve patient quality of life and meet the urgent market demand for safe pain medications.
Ensysce Biosciences Under Review: Zacks Small-Cap Research Assigns $16.45 Price Target
Real-time Intelligence: Benzinga Pro offers traders the fastest news alerts to stay updated on market movements.
Exclusive Content: The platform provides exclusive stories and insights generated by Benzinga reporters for its users.
Community Engagement: Over 10,000 serious traders are part of the Benzinga Pro community, enhancing collaboration and information sharing.
Market Winning Tools: Benzinga Pro is designed to help traders gain an edge in the markets with accurate stock market intelligence.
Diamond Equity Research Releases Update Note on Ensysce Biosciences, Inc. (NASDAQ: ENSC)
Ensysce Biosciences Updates: Ensysce Biosciences has made significant progress in its opioid therapeutic pipeline, including the launch of the PF614 Phase 3 trial and advancements in its overdose protection programs, supported by a $5.3 million NIDA grant.
Financial Performance: The company reported a narrower net loss of $1.7 million for Q2 2025, attributed to increased federal grant revenue, while maintaining a valuation of $22.00 per share based on successful execution of its clinical plans.
Ensysce Secures Brazilian Patent to Advance Safer Opioid Treatments
- Patent Approval: Ensysce received a Notice of Allowance from the Brazilian Patent Office for its TAAP™ and MPAR® technologies applied to additional opioid families, further strengthening its intellectual property and supporting the global development of safer analgesics.
- Technological Innovation: The application of MPAR® technology in Ensysce's opioids is expected to significantly reduce abuse potential and prevent overdose, enhancing patient safety without compromising pain relief, showcasing the transformative potential of its platforms.
- Market Expansion: This patent not only extends Ensysce's protection in North America and the EU but also strengthens its competitive position in the South American market, aiding the company's global strategy in the analgesic sector.
- Strategic Vision: Ensysce's CEO highlighted that this patent approval complements its recent patent for ADHD and opioid use disorder products, marking a significant step towards developing safer and more effective therapeutic options.
Ensysce Initiates PF614 Phase 3 Enrollment, Advancing Towards Commercialization
- Clinical Milestone: Ensysce Biosciences announced the enrollment of the first patient in the PF614 Phase 3 trial, marking a significant step towards commercialization and expected to enhance its competitive position in the safe opioid market.
- IP Expansion: The newly granted U.S. patent extends the protection for Ensysce's MPAR® overdose-prevention platform until 2042, strengthening the company's competitive moat in the field of safe opioid therapeutics.
- Regulatory Milestone: The FDA's endorsement of PF614's Chemistry, Manufacturing, and Controls strategy provides a clear pathway for commercial-scale production, reducing regulatory risks and enhancing the likelihood of successful approval.
- Capital Financing: Ensysce secured $4 million in convertible preferred stock financing, with the potential for an additional $16 million, significantly enhancing the company's financial flexibility as it advances the PF614 Phase 3 program.
Ensysce Initiates PF614 Phase 3 Enrollment, Advancing Towards Commercialization
- Clinical Milestone: Ensysce Biosciences announced the enrollment of the first patient in the PF614 Phase 3 study, marking a significant step towards commercialization, which is expected to enhance its competitiveness in the safer opioid market.
- IP Expansion: The newly granted U.S. patent extends the protection of Ensysce's MPAR® overdose-prevention platform until 2042, strengthening the company's competitive moat in opioid safety and supporting its future market positioning.
- FDA Regulatory Milestone: The FDA's agreement on PF614's Chemistry, Manufacturing, and Controls strategy provides a clear pathway to commercial production, reducing regulatory risks and enhancing Ensysce's competitiveness at key clinical and regulatory inflection points.
- Financing Strengthens Capital: Ensysce closed a $4 million convertible preferred stock financing, with potential access to an additional $16 million, significantly enhancing the company's financial flexibility to support PF614's Phase 3 development and other initiatives.
Ensysce Secures FDA Approval for PF614 Commercial Production Pathway
- Positive FDA Feedback: Ensysce Biosciences received written responses from the FDA confirming the appropriateness of its regulatory starting materials and specifications for PF614. This feedback provides Ensysce with a direct path to commercial production, marking a significant milestone in its drug development journey.
- Strengthened Partnerships: Ensysce is initiating commercial production of PF614 in collaboration with Purisys, LLC. This partnership will accelerate the market launch of the new analgesic, addressing the growing demand for safer pain relief options.
- Innovative Product Outlook: PF614 is Ensysce's TAAP™ oxycodone analogue and the leading product in its next-generation analgesic pipeline. Designed to provide safer pain relief while minimizing the risk of abuse and overdose, it holds significant market potential.
- Increased Executive Confidence: Ensysce CEO Dr. Lynn Kirkpatrick stated that the FDA's feedback enables the company to expedite PF614's market pathway, further solidifying its leadership in the analgesic market. This progress will help improve patient quality of life and meet the urgent market demand for safe pain medications.
Ensysce Biosciences Under Review: Zacks Small-Cap Research Assigns $16.45 Price Target
Real-time Intelligence: Benzinga Pro offers traders the fastest news alerts to stay updated on market movements.
Exclusive Content: The platform provides exclusive stories and insights generated by Benzinga reporters for its users.
Community Engagement: Over 10,000 serious traders are part of the Benzinga Pro community, enhancing collaboration and information sharing.
Market Winning Tools: Benzinga Pro is designed to help traders gain an edge in the markets with accurate stock market intelligence.
Diamond Equity Research Releases Update Note on Ensysce Biosciences, Inc. (NASDAQ: ENSC)
Ensysce Biosciences Updates: Ensysce Biosciences has made significant progress in its opioid therapeutic pipeline, including the launch of the PF614 Phase 3 trial and advancements in its overdose protection programs, supported by a $5.3 million NIDA grant.
Financial Performance: The company reported a narrower net loss of $1.7 million for Q2 2025, attributed to increased federal grant revenue, while maintaining a valuation of $22.00 per share based on successful execution of its clinical plans.
