Ensysce Biosciences Responder

$ENSC Pain treatment still faces the same challenge: delivering strong efficacy while improving safety. Physicians continue needing effective options for severe pain management, while regulators and healthcare systems keep pushing for approaches that better address abuse, misuse, and overdose risk. TAAP™ and MPAR® were developed around that challenge, with mechanisms designed directly into the molecular structure of the drug itself. As development of novel approached to treating pain continues, the broader focus remains on advancing known therapies designed for safer pain treatment for severe pain.

$ENSC Ensysce Biosciences recently announced expanded patent protection for its MPAR® overdose-protection technology following a newly issued patent from the Taiwan Intellectual Property Office, extending protection in the region through 2042. This patent expands coverage around the leading technology designed to modulate opioid exposure during overdose scenarios while maintaining exquisite analgesia when used as directed. With PF614 in Phase 3 development, continued growth of the company’s intellectual property portfolio adds further support around the broader MPAR® platform.

$ENSC As programs move to later-stage development, industry visibility starts mattering more. That was part of the significance behind Ensysce Biosciences’ participation in the inaugural Pain Therapeutics Summit Europe in Amsterdam, where biotech, pharma, and translational medicine leaders gathered to discuss the future of pain treatment. During the event, CEO Dr. Lynn Kirkpatrick presented “Chemical Control, Clinical Confidence: Rethinking Opioids,” focused on how TAAP™ and MPAR® were designed to reframe pain management at the molecular level. As attention around safer pain therapies rows, participation in scientific and strategic forums keeps emerging approaches part of the broader industry conversation.

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$ENSC We are pleased to share that Ensysce Biosciences will be participating in the inaugural Pain Therapeutics Summit Europe, taking place May 7–8 in Amsterdam. CEO, Dr. Lynn Kirkpatrick, will join industry and scientific leaders discussing the future of pain therapeutics, drug development, translational medicine, and next-generation treatment strategies. This conference comes at an important moment for the company as PF614 has entered Phase 3 and PF614-MPAR progresses as the first overdose-protected opioid. For Ensysce, this represents a compelling opportunity to highlight how TAAP™ and MPAR® address some of the most persistent unmet needs in pain medicine: delivering effective analgesia, while meaningfully reducing the risks of abuse deterrence, and overdose.

$ENSC We continue to increase our presence in key scientific and industry forums as our pipeline advances. We are pleased to join the upcoming Pain Therapeutics Summit Europe in Amsterdam, a gathering of leading biotechs, academic researchers, and pharmaceutical leaders shaping the next generation of pain therapies and CNS innovation. Our participation underscores the growing recognition of our differentiated approach driving the future of pain management. As our clinical programs advance, visibility within the scientific and medical community becomes increasingly critical. PF614 and PF614-MPAR are completely novel agents designed to alter opioid therapy, pairing a potent clinically meaningful analgesic with built‑in technologies designed to reduce abuse, misuse and overdose risk at the molecular level. You can learn more about the event here: paintherapeuticsummit.com

$ENSC We are approaching a stage where multiple elements are converging in a more defined way. Program are advancing through clinical evaluation, the IP portfolio continues to expand and capital is committed under an existing financing structure to support execution. At the same time, leadership engaging at the industry level, including participation in forums such as the Pain Therapeutics Summit Europe alongside clinical and research leaders shaping the future of pain management. Taken together, these activities are moving the narrative from isolated milestones toward more integrated execution. The focus is shifting to regulatory positioning and commercialization readiness.

$ENSC For opioids, adoption is not driven by efficacy alone. Prescribing decisions are shaped by safety profiles, institutional protocols, and payer evaluation frameworks. The ability to reduce risk at the system level is increasingly becoming a determining factor. This is where approaches that embed overdose protection directly into the drug’s chemistry begin to change the equation. At the upcoming Pain Therapeutics Summit Europe, this shift will be part of the broader industry conversation, including how platforms such as TAAP and MPAR may redefine the evaluation and use of opioid therapies in practice. As PF614 MPAR advances, the discussion begins to extend beyond development into real world positioning, and safety becomes the primary decision driver.

$ENSC Over time, execution has been building across multiple fronts: expanding IP protection, advancing clinical programs, and maintaining continuity in capital through a robust financing structure. The recent IRB approval to initiate the final stage of PF614-MPAR-102 marks a clear step forward for what we believe will be a groundbreaking product. It advances the program toward completion of a dataset around the overdose protection platform MPAR, building on prior results demonstrating contained opioid exposure across dosing conditions. This is reflected in recent external recognition, including the invitation for CEO Lynn Kirkpatrick to present at the Pain Therapeutics Summit Europe where industry leaders across biopharma and clinical research will address the future of safer pain management.

$ENSC Opioid overdose remains a major healthcare issue, with nearly 80,000 deaths annually in the U.S. A significant portion involves prescription opioids, often tied to patients taking more than prescribed. This leaves a clear gap between effective pain treatment and safety. We are targeting that gap with PF614-MPAR, designed to maintain therapeutic effect while limiting opioid exposure in overdose scenarios. This approach is supported by our clinical data and directly addresses one of the most common drivers of overdose: Taking too much medication. If this model holds through late-stage development, it could influence prescribing patterns and payer decisions as safety becomes a central factor.

$ENSC PF614-MPAR is designed to address a key gap in opioid therapy by controlling how excess drug exposure can be controlled. The goal is to maintain therapeutic levels when used as prescribed, while limiting additional opioid release if greater than prescribed doses are consumed. Clinical data have already shown this effect, with controlled exposure in overdose scenarios. This next phase is focused on further optimizing PF614-MPAR which is key for ensuring its broad applicability and regulatory labelling. How much value do you think an approach like this could add in a consumer market increasingly focused on safety?

$ENSC MPAR® received FDA Breakthrough Therapy designation, highlighting its unique profile in addressing opioid safety at a structural level. The program continues to advance clinically with support from NIDA, adding external validation with an understanding of the public health benefit[LK1] .. We see MPAR® as a core driver within our pipeline, with applications beyond pain management, including our programs in opioid use disorder, ADHA as well as other areas where overdose risk remains a challenge.

$ENSC Thank you for sharing this. PF614 is currently advancing through its Phase 3 program, while TAAP and MPAR continue to support a broader platform aimed at improving both efficacy and safety at the molecular level. Progress in a clinical-stage company is measured through these development milestones as programs move toward potential commercialization.

$ENSC We have received IRB approval to initiate Part 3 of the PF614-MPAR-102 study, the final stage of this clinical study. For a clinical-stage company, reaching the last phase of a study like this means the program is moving closer to a complete dataset around its overdose-protection profile, building on prior results that already showed reduced opioid exposure at higher doses. With this, we are advancing toward a key validation point for MPAR®. Focus remains on execution, completing this stage and delivering the first ever OD protection product .

$ENSC This financing builds on the structure we put in place in late 2025 to progress our programs designed to deliver the Next Generation of opioid analgesia and with overdose protection. Our goal has always been to provide safer effective pain relief to reduce suffering.

$ENSC This funding goes directly into what matters most right now; advancing safer opioid analgesics. TAAP™ and MPAR® remain central to our core strategy. These are designed to support multiple product candidates, extending beyond a single program. This financing helps sustain both the lead asset and the development of a broader pipeline built on the same foundation.

$ENSC We are pleased to announce that we have secured an additional $2 million financing under our existing agreement of up to $20 million. This tranche comes from investors who had already committed to the facility, which is important because it reflects continuity rather than a new, isolated capital event. For us, that continuity translates into stability in execution. This strengthens our near-term funding position and allows us to stay fully focused on advancing our clinical programs. It also supports the broader strategy we’ve been building around PF614 and our platform technologies, where consistent progress across development stages is key to moving toward long-term value creation.

$ENSC Pain management has long been limited by the trade-off between efficacy and safety. PF614 and the MPAR platform are designed to address both within the same molecular framework, aiming to reduce that constraint rather than work around it. This is where the approach aligns with the broader shift in the field.

$ENSC Thanks! Progress is defined by execution, and that is where the company remains focused. PF614 is advancing through Phase 3, while TAAP and MPAR continue to build a differentiated platform targeting both efficacy and safety at the molecular level. These are not isolated efforts. They reflect a structured clinical strategy designed to address long-standing gaps in pain management.

$ENSC At USASP, Dr. William Schmidt presented how PF614 and MPAR® are designed to address a core challenge in pain medicine: delivering effective relief while reducing misuse risk. These approaches reflect a shift in how opioid therapies are being developed.