Ensysce Biosciences, Inc. (ENSC): Business Model Canvas [Dec-2025 Updated]

You're looking at Ensysce Biosciences, Inc. right as they hit the critical late-stage trial phase for their next-generation, safer opioid candidates, and honestly, their whole business model is a tightrope walk between massive R&D spend and securing non-dilutive cash. This canvas maps out exactly how they plan to convert their proprietary TAAP™ and MPAR® platforms into value, especially considering that remaining $9.4 million in NIDA grant funding as of June 30, 2025, is key to bridging the gap until potential commercial sales. See below for the full strategic blueprint detailing their partnerships, cost structure, and revenue streams for this high-stakes pivot.

Ensysce Biosciences, Inc. (ENSC) - Canvas Business Model: Key Partnerships

You're looking at the core alliances that keep Ensysce Biosciences, Inc. moving its next-generation pain candidates through the clinic and toward the market. These aren't just vendor relationships; they are critical dependencies for their novel opioid platform.

National Institute on Drug Abuse (NIDA) Support

The financial backbone for the MPAR program comes significantly from the National Institute on Drug Abuse (NIDA). Ensysce Biosciences, Inc. secured the second installment of a $15 million, three-year grant, with the latest tranche being $5.3 million, which began funding on June 1, 2025. This specific $5.3 million is earmarked for reimbursement of research and development expenses under the MPAR program through May 2026. To give you context on the flow, federal grant funding totaled $1.4 million in the second quarter of 2025 and $0.5 million in the third quarter of 2025, reflecting the timing of eligible research activities. Honestly, this non-dilutive funding is crucial, especially considering the company's cash position, which stood at $1.7 million as of September 30, 2025.

Here's a quick look at the grant structure:

Clinical Research Organization (CRO) Execution with Rho, Inc.

Executing the pivotal trials requires specialized expertise, which Ensysce Biosciences, Inc. sources through Rho, Inc. Rho, Inc. was selected to conduct the landmark PF614-301 study, which is a multicenter, randomized, double-blind, placebo- and active-controlled trial evaluating PF614 for moderate to severe post-surgical pain. Rho, Inc. brings serious credentials to the table; they have successfully managed over 90 neurology and psychiatry trials across more than 840 sites over the last five years. This engagement is a direct move to validate PF614's efficacy and safety profile as they target market readiness within an estimated 18-24 months for PF614 trials.

Drug Product Development with Galephar Pharmaceutical Research

For the actual manufacturing and supply chain, Ensysce Biosciences, Inc. established a product development and supply agreement in January 2025 with Galephar Pharmaceutical Research, Inc.. Galephar's role is to support the development, manufacture, packaging, and testing for both PF614 and PF614-MPAR drug products, which are essential for both ongoing clinical trials and any future commercial launch. The financial terms here are milestone-based; Ensysce pays Galephar upon achieving defined milestones at up to 1.2 times Galephar's costs, though there is a cap on that payment structure. It's a standard pharma outsourcing model, but critical for scaling up the physical product.

Regulatory Alignment with the FDA

The relationship with the Food and Drug Administration (FDA) is paramount, particularly given the novel nature of the overdose protection technology. Ensysce Biosciences, Inc.'s lead candidate, PF614-MPAR, already holds the FDA's Breakthrough Therapy designation. This designation itself is a major partnership milestone, signaling the FDA recognizes the potential to address an unmet need. More recently, in late 2025, the FDA provided Written Responses agreeing with all of Ensysce's proposed plans regarding the approach to manufacture PF614 drug substance, which provides a direct path to commercial production with their manufacturing partner, Purisys, LLC. Furthermore, the company has confirmation of eligibility for a 505(b)(2) regulatory pathway for PF614-MPAR, which suggests a potentially streamlined approval process.

You should track the FDA engagement closely; the company is working to align on overdose protection labeling and the regulatory path forward.

• - PF614-MPAR holds Breakthrough Therapy designation.
• - FDA agreed with Ensysce's proposed plans for PF614 manufacture.
• - PF614-MPAR is confirmed eligible for a 505(b)(2) regulatory pathway.
• - PF614-301 pivotal Phase 3 trial initiated in Q3 2025.

Ensysce Biosciences, Inc. (ENSC) - Canvas Business Model: Key Activities

You're looking at the core engine driving Ensysce Biosciences, Inc. (ENSC) right now-the activities that consume capital but are necessary to push their novel pain and OUD candidates toward market. It's all about execution in the clinic and securing the runway to do it.

Executing the pivotal Phase 3 PF614-301 clinical trial

The main focus here is the pivotal Phase 3 PF614-301 study, which kicked off in July 2025. This trial is designed to prove the efficacy of PF614 in managing moderate to severe post-surgical pain following abdominoplasty, while also validating its abuse-deterrent properties. Ensysce tapped Rho, Inc., a clinical research organization with deep experience in CNS and pain trials, to run this critical study. Remember, Phase 3 is the final human testing stage before you can even think about submitting for regulatory approval, so this activity is make-or-break for the lead product. Also, the PF614-MPAR overdose protection therapy saw its related PF614-MPAR-102 study complete Part 2 enrollment in the second quarter of 2025, while the PF614-MPAR product itself is in Phase 1b development.

Research and Development (R&D) for TAAP™ and MPAR® platforms

The R&D spend reflects the intensity of these late-stage and platform advancements. For the second quarter of 2025, Research & Development Expenses hit $1.9 million, ramping up to $3.0 million in the third quarter of 2025. This spending is directly tied to advancing both the pain and Opioid Use Disorder (OUD) pipelines. The PF614-MPAR program, which combines the TAAP™ and MPAR® technologies, secured the coveted FDA Breakthrough Therapy designation in January 2025. Furthermore, in the third quarter of 2025, Ensysce Biosciences received encouraging feedback from the FDA regarding the regulatory pathway for PF614-MPAR, specifically confirming eligibility for a 505(b)(2) pathway. The OUD program is also moving, with PF9001, the lead candidate, progressing toward non-clinical studies to support a future Investigational New Drug (IND) application. It's a heavy lift, but the platforms are what give them their unique value proposition.

Here's a quick look at the R&D cost trajectory:

Managing and expanding the global intellectual property (IP) portfolio

Protecting the technology is a non-stop activity, especially given the platform nature of TAAP™ and MPAR®. In the second quarter of 2025, Ensysce Biosciences secured a Notice of Allowance from the U.S. Patent and Trademark Office for a patent covering the composition and use of PF9001, which bolsters their OUD intellectual property. More recently, in December 2025, the company announced a Notice of Allowance for a new patent covering the MPAR® technology itself, extending protection through 2042. This specific research supporting the MPAR patent was funded by the National Institute on Drug Abuse (NIDA) under Award Number DA047682. You defintely want to see that patent life extended.

Securing non-dilutive federal grants and equity financing

Since Ensysce Biosciences is pre-revenue, grant funding and financing are crucial operational activities that keep the lights on and the trials running. Grant revenue recognition is tied directly to incurring eligible costs, so it fluctuates quarter-to-quarter based on R&D activity. For the six months ended June 30, 2025, federal grant revenue recognized was $2.69 million. However, Q3 2025 saw grant funding drop to $0.5 million, down from $3.4 million in Q3 2024, due to the timing of research eligible under the MPAR grant. On the equity side, the company completed a convertible preferred stock offering in November 2025, bringing in gross proceeds of $4 million, with the potential for an additional $16 million over the next 24 months. This financing came as cash reserves were tight; cash and cash equivalents stood at $1.7 million as of September 30, 2025, compared to $3.5 million at the end of 2024. The remaining NIH MPAR grant funding was reported as $9.4 million as of June 30, 2025.

Here's the breakdown of recent funding inflows and cash position:

• Federal Grants Q3 2025 Funding: $0.5 million
• Federal Grants Q2 2025 Funding: $1.4 million
• NIDA Grant Installment Received (Q2 2025): $5.3 million (part of a $15 million, three-year grant)
• November 2025 Convertible Preferred Stock Gross Proceeds: $4 million
• Potential Future Financing from Tranches: Up to $16 million
• Cash as of September 30, 2025: $1.7 million

Ensysce Biosciences, Inc. (ENSC) - Canvas Business Model: Key Resources

You're looking at the core assets Ensysce Biosciences, Inc. (ENSC) is relying on to drive its value proposition in the severe pain and CNS therapeutics space. These aren't just ideas; they are tangible, protected, and validated elements.

• - Proprietary TAAP™ (Trypsin-Activated Abuse Protection) and MPAR® (Multi-Pill Abuse Resistance) technologies.
• - Clinical data supporting PF614-MPAR's FDA Breakthrough Therapy designation.
• - Remaining NIDA grant funding, approximately $9.4 million as of June 30, 2025.
• - Core scientific and executive management team expertise.

The intellectual property surrounding the core platforms is a major asset. The MPAR® technology, which provides built-in overdose protection, has secured a new U.S. Patent, extending its protection through the year 2042. This platform is being leveraged beyond opioids, with Ensysce Biosciences applying it to develop safer treatments for ADHD and opioid use disorder (OUD), including their lead OUD candidate, PF9001. The TAAP™ platform provides the abuse-deterrent component, creating a dual safety approach when combined with MPAR®.

The clinical validation for PF614-MPAR is significant, as it earned the U.S. Food and Drug Administration (FDA)'s prestigious Breakthrough Therapy designation in January 2025. This designation is a direct result of compelling early data showing the product's potential to address an unmet medical need. Here's a snapshot of the key data points supporting that designation:

Financially, the non-dilutive funding from the National Institute on Drug Abuse (NIDA) is a critical resource, effectively offsetting some research and development burn. As of June 30, 2025, the remaining balance of this specific NIDA grant funding was reported at $9.4 million. This is part of a larger, multi-year, $15 million grant, the second installment of $5.3 million of which was received in Q2 2025, available for reimbursement of MPAR program expenses through May 2026. To be fair, the company's cash and cash equivalents were $2.2 million as of that same date, so that grant runway is essential for near-term operations.

The team's expertise is embedded in the successful navigation of these complex scientific and regulatory hurdles. The company is advancing PF614 into a pivotal Phase 3 trial (PF614-301) and is working collaboratively with the FDA on the clinical and non-clinical roadmap for PF614-MPAR, including alignment on overdose protection labeling. This alignment on a potential streamlined 505(b)(2) regulatory pathway is a direct result of the management team's strategic execution.

Ensysce Biosciences, Inc. (ENSC) - Canvas Business Model: Value Propositions

You're looking at the core reasons why a patient, physician, or payer would choose Ensysce Biosciences, Inc. (ENSC) over the existing options in the severe pain and Opioid Use Disorder (OUD) markets. The value here isn't just efficacy; it's about engineering safety directly into the molecule.

Safer opioid pain relief with built-in abuse deterrence (TAAP™) is central. This isn't just a coating; it's chemistry designed to control release when taken orally and resist tampering. You saw the momentum build throughout 2025, highlighted by the initiation of the pivotal Phase 3 study for PF614, specifically the PF614-301 trial, in July 2025 to manage severe post-surgical pain. This product is engineered to deliver the necessary analgesic effect while actively deterring abuse.

The oral overdose protection for prescription opioids (MPAR®) is perhaps the most compelling safety feature. The combination product, PF614-MPAR, has achieved significant regulatory recognition, including the FDA's Breakthrough Therapy designation. Clinical data from Part 1 of the PF614-MPAR-102 study confirmed that a 100 mg dose provided protection from excessive opioid release even when a greater-than-prescribed dose was consumed. This technology is designed to mitigate the risk of unintentional overdose, a massive public health concern.

For the effective management of severe pain, like post-surgical pain, the focus is on PF614 and its combination with MPAR. The ongoing Phase 3 trial is designed to demonstrate that PF614 can provide superior pain relief while supporting a safer transition to non-opioid care post-surgery.

Then there's the OUD segment, where the novel treatment candidate (PF9001) for Opioid Use Disorder (OUD) offers a potential paradigm shift from methadone. PF9001 is designed to be a safer alternative, showing reduced potential for cardiovascular side effects and incorporating that MPAR overdose protection. This program is getting serious backing, supported by a multi-year HEAL grant from NIDA. You should note that Ensysce Biosciences, Inc. received a Notice of Allowance from the U.S. Patent and Trademark Office for the composition and use of PF9001 in April 2025.

Here's a quick look at the pipeline progress that underpins these value propositions as of late 2025:

To be fair, you have to look at the financial context supporting this development. As a clinical-stage company, the focus is on R&D spend, which was $3.0 million in Q3 2025, up from $1.7 million the year prior. The net loss for Q3 2025 was $3.7 million, compared to a gain of $0.7 million in Q3 2024. The cash position reflects the burn, with cash and equivalents at $1.7 million as of September 30, 2025, down from $3.5 million at the end of 2024. However, the company secured a crucial financing event in November 2025, completing a convertible preferred stock offering with gross proceeds of $4 million. This suggests a near-term runway extension to support these critical late-stage trials.

The market sentiment, based on ownership structure, shows significant conviction from within the company, with insider ownership reported at 84.7%, while institutional ownership sits at a relatively low 11.06%. This is a classic biotech dynamic: high insider belief funding the journey to de-risking milestones.

The value propositions are clearly tied to de-risking the pipeline through clinical execution and securing IP. You can see the key operational focus points:

• Initiated pivotal Phase 3 trial for PF614 in July 2025.
• Validated MPAR overdose protection across the planned commercial dosage range.
• Secured patent allowance for PF9001 in April 2025.
• Q3 2025 R&D expenses totaled $3.0 million.
• Cash on hand as of September 30, 2025, was $1.7 million.

Finance: draft 13-week cash view by Friday.

Ensysce Biosciences, Inc. (ENSC) - Canvas Business Model: Customer Relationships

You're looking at how Ensysce Biosciences, Inc. (ENSC) manages its critical external relationships as it pushes its novel pain candidates toward market. This isn't about mass-market advertising yet; it's about deep, targeted engagement with the gatekeepers and funders.

Collaborative, high-touch engagement with the FDA and NIDA

The relationship with regulatory and funding bodies is central to Ensysce Biosciences, Inc.'s near-term strategy. This engagement is characterized by specific milestones and significant financial backing tied directly to scientific progress. For instance, PF614-MPAR has secured the FDA's prestigious Breakthrough Therapy designation, a first for an opioid drug product. This designation signals a high level of regulatory interest and potential for a streamlined path.

Funding from the National Institute on Drug Abuse (NIDA) validates the overdose protection technology. Ensysce Biosciences, Inc. had its development bolstered by a $14 million multi-year award from NIDA in 2024. More recently, the company received a second $5.3 million installment of a $15 million, three-year grant from NIDA, with this phase beginning on June 1, 2025. As of June 30, 2025, the remaining NIH MPAR grant funding stood at $9.4 million. The high-touch nature is evident in the July 23, 2025, FDA meeting, which focused on the clinical and non-clinical roadmap for PF614-MPAR's approval, with a key emphasis on achieving overdose protection labeling. The company also received positive FDA feedback on the PF614 manufacturing approach on November 20, 2025.

The financial reliance on these relationships is clear when looking at revenue sources:

Scientific advocacy and education with key opinion leaders (KOLs) and pain specialists

Advocacy involves engaging experts to build credibility around the novel abuse-deterrent and overdose-protection mechanisms. The company's Chief Commercial Officer, Geoff Birkett, chaired the Fierce New Product Planning Summit 2025, held September 8-11, 2025, presenting a case study on the launch process. This is a direct effort to educate peers on commercialization strategy.

External validation through research reports also plays a role in this relationship segment. For example, Diamond Equity Research released an Update Note on November 17, 2025, which was commissioned by Ensysce Biosciences, Inc.. The financial arrangement for this advocacy support involved the issuer paying $113,750 for research services that began on October 10, 2022, structured with an annual fee of $35,000 for the first two years, followed by quarterly upfront payments of $8,750 for subsequent years. Also, in March 2025, CEO Dr. Lynn Kirkpatrick participated in a discussion with Dr. Neel Pathak of Creighton University regarding the opioid crisis and next-generation opioids.

Investor relations for continuous capital market access

Given the clinical-stage nature, investor relations is about securing the necessary capital to fund operations, especially with management having disclosed substantial doubt about the company's ability to continue as a going concern based on pre-financing cash levels. The relationship is transactional, focused on milestones that de-risk the investment.

Recent financing activity demonstrates this continuous access:

• Closed a $4 million convertible preferred stock financing in November 2025.
• This financing has an upside potential of up to $16 million in additional funding over the next 24 months.
• The initial tranche included 50% warrant coverage exercisable for five years.
• Prior to this, gross proceeds of approximately $2.2 million were generated from an April 2025 warrant inducement and approximately $1.1 million from a March 2025 registered direct offering.

The cash position reflects the burn rate against these capital infusions. Cash and cash equivalents were reported at $1.7 million as of September 30, 2025, following the November financing. This followed a balance of $2.21 million on June 30, 2025, and $3.1 million on March 31, 2025.

Future direct sales and medical affairs support for prescribers

While Ensysce Biosciences, Inc. is currently pre-commercial, the groundwork for engaging prescribers is being laid by the commercial team. The Chief Commercial Officer, Geoff Birkett, is currently spearheading preparations for the launch of the first-in-class analgesic, PF614. This preparation is directly linked to clinical progress, as the pivotal PF614-301 Phase 3 trial was initiated in July 2025. The company anticipates PF614 will be on track for Phase 3 completion within the next 18 months. The future relationship with prescribers will be supported by a structure being shaped now to combat severe pain while reducing abuse and overdose risks.

Ensysce Biosciences, Inc. (ENSC) - Canvas Business Model: Channels

You're looking at how Ensysce Biosciences, Inc. (ENSC) gets its science and, eventually, its products, out to the world. For a clinical-stage company, the channels are heavily weighted toward validation and preparation for market, not mass sales yet. Here's the breakdown of the current pathways as of late 2025.

Clinical Research Organizations (CROs) for Trial Execution and Site Management

The execution of your pivotal trials is outsourced to specialized partners. This is how you maintain scientific rigor without ballooning your internal operational headcount. For the lead program, PF614, which entered its pivotal Phase 3 study (PF614-301) in July 2025, Ensysce Biosciences has an alliance with Rho, Inc.

This collaboration is key for the trial, which is evaluating PF614 for severe post-surgical pain. To give you a sense of the current investment in this channel, Research & Development Expenses for the third quarter of 2025 hit $3.0 million, a significant portion of which goes to external trial costs like those managed by Rho, Inc.

The company is also advancing its PF614-MPAR overdose-protection therapy, having fully enrolled Part 2 of its PF614-MPAR-102 study during Q2 2025.

Medical and Scientific Conferences, Such as PAINWeek 2025, for Data Dissemination

Getting data in front of key opinion leaders is a primary channel for building scientific credibility. Ensysce Biosciences used PAINWeek 2025, the world's largest pain management conference, for this purpose. They hosted a symposium titled 'Pain Management, RE-Invented: A New Era for Analgesia' on September 3, 2025, in Las Vegas.

The event was well-received, with one report noting about 400 attendees. Following the conference, video highlights were released on October 10, 2025, extending the reach of the data presented.

Here's a snapshot of the recent scientific engagement:

Future Pharmaceutical Distributors and Wholesalers for Drug Delivery

While Ensysce Biosciences is pre-commercial, the groundwork for distribution is being laid now. In December 2024, the company announced a strategic partnership with a leading specialty drug manufacturer to handle the development and commercial launch of PF614 and PF614-MPAR.

This partner is set to provide the initial commercial batches and manage the entire manufacturing process, including packaging, labeling, and shipment of the products upon regulatory approval. This means the physical distribution channel is largely pre-defined through this equity-backed agreement, designed for a seamless transition from approval to market entry. The company's cash position as of September 30, 2025, was $1.7 million, making these external manufacturing/distribution commitments critical to manage carefully.

Direct Communication with Investors via SEC Filings and Press Releases

For investors, the primary channel for official, audited information is the SEC. Ensysce Biosciences reported its third quarter 2025 financial results on November 14, 2025, via an 8-K filing, covering the period ended September 30, 2025.

The company recently raised capital, announcing on November 17, 2025, a financing that secured $4 million in gross proceeds, unlocking up to $20 million in total financing. You can track the official regulatory documentation, such as the Form S-3, filed on December 2, 2025.

Key investor touchpoints in late 2025 included:

• FDA feedback on PF614-MPAR received on November 20, 2025.
• Q3 2025 Earnings Release on November 14, 2025.
• Financing announcement on November 17, 2025.
• Latest SEC Filing (S-3) on December 2, 2025.

Finance: draft 13-week cash view by Friday.

Ensysce Biosciences, Inc. (ENSC) - Canvas Business Model: Customer Segments

You're looking at the distinct groups Ensysce Biosciences, Inc. (ENSC) targets with its innovative, abuse-deterrent opioid technologies. The numbers define the scale of the opportunity for their PF614 and PF9001 programs.

Patients suffering from severe acute and chronic pain represent a massive addressable market. The U.S. pain management market was estimated to reach USD 32.79 billion in 2025. Globally, the chronic pain market size was estimated at USD 77.30 Bn in 2025, with North America holding a 40.8% share. Chronic pain affects approximately 20% of US adults. For Ensysce Biosciences, Inc. (ENSC), the focus is on severe pain, where the musculoskeletal pain segment already accounted for 41.2% of the U.S. pain management market share in 2024.

Healthcare Providers (HCPs) and pain management specialists are the gatekeepers seeking alternatives. The market shift is evident as legislative efforts encourage greater financial transparency between physicians and industry, with device company payments surpassing drug company payments in 2018 and persisting through 2022. Ensysce Biosciences, Inc. (ENSC) is advancing PF614 into a pivotal Phase 3 trial, a critical step for HCP adoption.

Government agencies and payers are driven by the economic and human toll of the opioid crisis. The opioid abuse cost was estimated at $1.5 trillion annually. In one measure, 8.9 million people aged 12 years and older misused opioids in 2023. For the PF9001 program targeting Opioid Use Disorder (OUD), the patient pool is substantial; one data point suggests 1.7% (or about 4.8 million people) had an Opioid Use Disorder in 2024. Government support is concrete: Ensysce Biosciences, Inc. (ENSC) received a $5.3 million installment from the National Institute on Drug Abuse (NIDA) in Q2 2025, part of a larger $15 million, three-year grant. As of June 30, 2025, the remaining NIH MPAR grant funding was $9.4 million.

The final segment, Patients with Opioid Use Disorder (OUD), is directly addressed by the PF9001 program. The company secured a U.S. patent for PF9001, their lead OUD drug candidate. The need is high, as in 2024, only about 2.2 million people received medication for opioid use disorder (MOUD). Ensysce Biosciences, Inc. (ENSC) is working to provide a safer methadone alternative leveraging its proprietary technologies.

Here's a quick view of the quantitative landscape for Ensysce Biosciences, Inc. (ENSC) customer segments as of late 2025:

Ensysce Biosciences, Inc. (ENSC) reported cash and equivalents of $1.7 million as of September 30, 2025, with a net loss of $3.7 million in Q3 2025. The company recognized $2.69 million in federal grant revenue for the first six months of 2025. They hold over 100 patents.

Ensysce Biosciences, Inc. (ENSC) - Canvas Business Model: Cost Structure

You're looking at the major cash outlays for Ensysce Biosciences, Inc. as of late 2025. For a clinical-stage company, the cost structure is heavily weighted toward advancing the pipeline, meaning Research and Development (R&D) dominates the spend.

The Research and Development (R&D) expenses hit $3.0 million in the third quarter of 2025, up from the $1.9 million reported for the second quarter of 2025. This burn rate reflects the increased activity across their lead programs.

Clinical trial costs are a significant component driving that R&D spend. Specifically, the initiation of the pivotal Phase 3 study of PF614, designated PF614-301, occurred in July 2025. This trial, along with increased pre-clinical work for PF614-MPAR, directly translates into higher external research and development costs, including fees paid to Contract Research Organizations (CROs) like Rho, Inc., and patient enrollment expenses.

General and Administrative (G&A) costs, which cover the day-to-day operations outside of direct research, were reported at $1.20 million for Q2 2025. For Q3 2025, G&A expenses were $1.3 million, showing relative consistency quarter-over-quarter.

Intellectual property maintenance and legal fees are necessary expenditures to protect the proprietary platforms. For instance, in Q2 2025, the company received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent covering the composition and use of PF9001. Also, in December 2025, Ensysce Biosciences announced broader patent protection for its MPAR overdose protection technology. These activities contribute to the overall G&A and legal budget.

Here's a quick look at how the main operating expenses stacked up for the mid-year and third quarters of 2025:

The cost structure is primarily defined by these key drivers:

• - High Research and Development (R&D) expenses, totaling $3.0 million in Q3 2025.
• - Clinical trial costs, including CRO fees and patient enrollment expenses for the PF614 Phase 3 trial initiated in July 2025.
• - General and Administrative (G&A) costs, which were $1.20 million in Q2 2025 and $1.3 million in Q3 2025.
• - Intellectual property maintenance and legal fees, evidenced by patent allowance in Q2 2025 and expanded protection announced in December 2025.

Ensysce Biosciences, Inc. (ENSC) - Canvas Business Model: Revenue Streams

Ensysce Biosciences, Inc. currently relies on non-sales related funding to support its clinical-stage operations, with a clear path toward future product revenue post-approval.

The immediate, realized revenue streams are heavily weighted toward non-dilutive government funding and capital market activities. Federal grant revenue for the third quarter of 2025 was reported at $0.5 million.

To sustain the advancement of its pipeline, particularly the Phase 3 program for PF614, Ensysce Biosciences secured proceeds from equity financing. In November 2025, the company closed an initial tranche of a convertible preferred financing totaling $4.0 million.

This financing structure also provides significant future liquidity potential, as there is upside to potentially $16 million of additional funding available through future tranches over the next 24 months.

Here is a look at the recent financial inputs supporting operations:

The long-term, product-based revenue model for Ensysce Biosciences centers on successful regulatory clearance for its lead candidates.

• Future milestone payments and royalties from potential licensing agreements.
• Future commercial sales of PF614 and PF614-MPAR post-FDA approval.