ENSYSCE BIOSCIENCES, Inc. (ENSC): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage rapide de l'innovation pharmaceutique en évolution, ENSYSCE Biosciences, Inc. (ENSC) émerge comme un pionnier révolutionnaire, révolutionnant la gestion de la douleur par le biais de technologies de mise en œuvre de médicaments. En abordant ingénieusement les défis critiques de la dépendance aux opioïdes et de la sécurité des patients, la toile de modèle commercial unique de l'entreprise révèle une approche sophistiquée qui mélange l'ingénierie moléculaire, les partenariats stratégiques et les solutions pharmaceutiques transformatrices. Plongez dans le plan complexe de la façon dont ENSC remodèle l'avenir des traitements de substances contrôlés, offrant un récit convaincant de l'excellence scientifique et de la vision stratégique.

ENSYSCE BIOSCIENCES, Inc. (ENSC) - Modèle d'entreprise: partenariats clés

Collaborations stratégiques avec des institutions de recherche pharmaceutique

En 2024, EnsySce Biosciences a établi des partenariats stratégiques avec les institutions de recherche suivantes:

Institution	Domaine de mise au point	Détails du partenariat
MD Anderson Cancer Center	Développement de médicaments en oncologie	Collaboration technologique PK-Phosphate Platform Technology
Université du Texas Southwestern Medical Center	Recherche de livraison de médicaments	Technologie innovante des opioïdes dissuasites sur l'abus

Partenariats potentiels avec les centres médicaux académiques

Ensysce Biosciences a des discussions en cours avec des partenaires académiques potentiels:

• École de médecine de Harvard - Développement de médicaments neurologiques
• École de médecine de l'Université de Stanford - Recherche de gestion de la douleur
• Université Johns Hopkins - Innovation pharmaceutique

Accords de licence pour les technologies innovantes de livraison de médicaments

Les accords de licence actuels comprennent:

Technologie	Partenaire de licence	Valeur estimée
Plate-forme PK-phosphate	Développement interne propriétaire	Investissement de R&D de 3,2 millions de dollars
Technologie des opioïdes sous-déterrent de l'abus	Partenaire pharmaceutique confidentiel	5,7 millions de dollars de paiement de jalons potentiels

Collaboration avec les organisations de recherche sous contrat (CROS)

Ensysce Biosciences travaille avec les CRO suivants:

• IQVIA - Gestion des essais cliniques
• Parexel International - Conformité réglementaire
• Medpace - Support de recherche en oncologie

Budget total de collaboration CRO pour 2024: 4,5 millions de dollars

ENSYSCE BIOSCIENCES, Inc. (ENSC) - Modèle d'entreprise: Activités clés

Développement de formulations de médicaments de gestion de la douleur innovants

EnsySce Biosciences se concentre sur le développement de nouvelles technologies de médicaments de gestion de la douleur avec des approches spécifiques d'ingénierie moléculaire.

Paramètre de développement de médicaments	Détails spécifiques
Programmes de recherche actifs	2 plates-formes de formulation de médicaments de gestion de la douleur primaire
Investissement annuel de R&D	3,2 millions de dollars (2023 Exercice)
Demandes de brevet	5 brevets de formulation pharmaceutique en attente

Recherche et essais cliniques pour les technologies pharmaceutiques sous-déterminées

La société mène des recherches spécialisées ciblant les mécanismes d'administration de médicaments résistants aux abus.

• Plateforme PDS: Technologie pharmaceutique dissuasif sur abus
• Technologie de Delstra: approche d'ingénierie moléculaire à libération contrôlée
• Étape de l'essai clinique: phase II pour les candidats au médicament primaire

Génie moléculaire des plates-formes de médicament à libération contrôlée

Plate-forme technologique	Statut de développement	Application potentielle
Technologie de l'abus de PDS	Étape de recherche avancée	Gestion de la douleur opioïde
Plateforme moléculaire de Delstra	Développement préclinique	Formulations à libération prolongée

Développement de la propriété intellectuelle et gestion des brevets

EnsySce Biosciences maintient une approche stratégique de la protection de la propriété intellectuelle.

• Portfolio total des brevets: 8 brevets accordés
• Frais de poursuite en brevet: 750 000 $ (2023)
• Domaines d'intervention de la propriété intellectuelle: technologies éterondies d'abus, mécanismes à libération contrôlée

ENSYSCE BIOSCIENCES, Inc. (ENSC) - Modèle d'entreprise: Ressources clés

Technologies de livraison de médicaments propriétaires

Ensysce Biosciences entretient deux technologies propriétaires de base:

• Technologie de livraison de médicaments Plurisyn ™
• Mécanisme d'administration de médicament Biopigment ™

Technologie	Statut de brevet	Étape de développement
Plurisyn ™	Multiples brevets USPTO	Phase de développement avancé
Biopigment ™	Droits de propriété intellectuelle exclusive	Étape de recherche clinique

Équipe de recherche et développement scientifique

Composition de l'équipe	Compétence	Qualifications
12 chercheurs	Chimie pharmaceutique	doctorat Chercheurs de niveau
6 chercheurs seniors	Mécanismes d'administration de médicament	Plus de 20 ans d'expérience combinée

Installations de recherche

Spécifications de l'installation:

• 2 laboratoires de recherche avancés
• Espace de recherche total: 8 500 pieds carrés.
• Environnement de recherche conforme aux BPF

Portefeuille de brevets

Catégorie de brevet	Nombre de brevets	Couverture géographique
Mécanismes d'administration de médicament	7 brevets actifs	États-Unis, Europe
Technologies propriétaires	5 applications en attente	Protection internationale des brevets

ENSYSCE BIOSCIENCES, Inc. (ENSC) - Modèle d'entreprise: propositions de valeur

Solutions pharmaceutiques innovantes sous-tendrentes

Ensysce Biosciences se concentre sur le développement PF614, une formulation d'oxycodone sous-estimée des abus conçue pour prévenir l'abus de drogues.

Caractéristique des médicaments	Spécification
Type de médicament	Oxycodone à libération prolongée
Mécanisme de dissuasion des abus	Technologie propriétaire résistant
Taille du marché potentiel	11,3 milliards de dollars sur le marché de la gestion de la douleur

Technologies avancées de livraison de médicaments à libération contrôlée

• Plateforme technologique de Pharmatam® propriétaire
• Permet des mécanismes de libération de médicaments précis
• Application potentielle dans plusieurs catégories pharmaceutiques

Réduction potentielle des risques de dépendance aux opioïdes

Statistique de la dépendance aux opioïdes	Point de données
Décès annuels sur la surdose des opioïdes (États-Unis)	80 411 en 2021
Coût économique de la crise des opioïdes	1,5 billion de dollars (2020)

Amélioration de la sécurité des patients dans les traitements de gestion de la douleur

Les technologies d'Ensysce visent à minimiser les médicaments abusives grâce à des stratégies innovantes de formulation de médicaments.

• Réduit le potentiel de manipulation de la dose
• Empêche l'écrasement ou la rupture des médicaments
• Limite le potentiel de méthodes alternatives de consommation de médicaments

ENSYSCE BIOSCIENCES, Inc. (ENSC) - Modèle d'entreprise: Relations clients

Engagement direct avec les sociétés pharmaceutiques

Depuis le quatrième trimestre 2023, EnsySce Biosciences entretient des stratégies d'engagement directes avec des partenaires pharmaceutiques axés sur les technologies innovantes de développement de médicaments.

Type d'engagement	Nombre de partenariats actifs	Focus de la collaboration
Collaboration pharmaceutique	3 partenariats actifs	PDS ™ et BEMA® Drug Delivery Technologies
Discussions sur l'octroi de licences	2 négociations en cours	Formulations de médicaments de gestion de la douleur

Partenariats de recherche collaborative

ENSYSCE maintient des collaborations de recherche stratégique ciblant le développement pharmaceutique spécialisé.

• Partenariat de recherche universitaire avec l'Université du Texas
• Contrat de développement de médicaments collaboratifs avec Private Pharmaceutical Research Institute
• Programme de recherche conjoint axé sur les formulations d'opioïdes dissuastiques

Soutien technique au développement de médicaments

Les services de soutien technique fournis par ENSYSCE comprennent une consultation complète de développement de médicaments.

Service d'assistance	Heures de soutien annuelles	Gamme de coûts de consultation
Consultation de formulation	480 heures	$150,000 - $250,000
Transfert de technologie	240 heures	$75,000 - $125,000

Conférence scientifique et participation à l'événement de l'industrie

ENSYSCE participe activement aux conférences de l'industrie pharmaceutique pour présenter les innovations technologiques.

• A assisté à 7 conférences pharmaceutiques internationales en 2023
• Présenté 4 affiches scientifiques sur les technologies d'administration de médicaments
• Participé à 12 événements de réseautage de l'industrie

ENSYSCE BIOSCIENCES, Inc. (ENSC) - Modèle d'entreprise: canaux

Équipe de vente directe ciblant les fabricants pharmaceutiques

Depuis le quatrième trimestre 2023, Ensysce Biosciences maintient une équipe de vente spécialisée axée sur les partenariats pharmaceutiques. L'équipe comprend 7 représentants des ventes directes ayant une expertise dans le développement de médicaments pharmaceutiques.

Métrique de l'équipe de vente	2023 données
Représentants totaux des ventes directes	7
Les fabricants pharmaceutiques cibles contactés	42
Négociations de partenariat réussi	3

Publications scientifiques et présentations de recherche

Ensysce Biosciences explique les publications scientifiques comme un canal critique pour communiquer les innovations technologiques.

• Publications scientifiques totales en 2023: 6
• Journaux à comité de lecture: 4
• Présentations de recherche de la conférence: 8

Conférences de l'industrie et salons de commerce pharmaceutique

Type de conférence	2023 Participation	Portée estimée
Conférences pharmaceutiques nationales	3	1 200 participants
Symposiums internationaux de biotechnologie	2	850 participants

Plateformes de communication scientifique et investisseur en ligne

Les canaux numériques représentent une stratégie de communication importante pour les biosciences EnsySCE.

• Site Web d'entreprise Visiteurs mensuels uniques: 12 500
• LinkedIn adepte: 4 200
• Investisseurs Relations Webinaires Participants en 2023: 215

ENSYSCE BIOSCIENCES, Inc. (ENSC) - Modèle d'entreprise: segments de clientèle

Fabricants de médicaments pharmaceutiques

EnsySce Biosciences cible les sociétés pharmaceutiques qui développent des médicaments contre les substances contrôlées.

Segment de clientèle	Taille du marché	Engagement potentiel
Grandes sociétés pharmaceutiques	1,3 billion de dollars sur le marché pharmaceutique mondial	Licence PF614 TECHNOLOGIE DE MAINE
Entreprises pharmaceutiques de taille moyenne	Segment de marché de 350 milliards de dollars	Partenariats collaboratifs de développement de médicaments

Institutions de recherche sur la gestion de la douleur

Les organisations de recherche se sont concentrées sur le développement de solutions innovantes de gestion de la douleur.

• Financement de la recherche sur la douleur des National Institutes of Health (NIH): 456 millions de dollars en 2023
• Centres de recherche universitaires intéressés par les technologies de drogue dissuastiques
• Collaboration potentielle sur les plateformes de livraison de médicaments résistantes aux propriétaires propriétaires

Fournisseurs de soins de santé spécialisés dans les traitements de substances contrôlées

Pratiques médicales et cliniques gérant la douleur chronique et le traitement de la toxicomanie.

Type de fournisseur	Volume de marché	Intérêt potentiel
Cliniques de gestion de la douleur	8 400 cliniques spécialisées aux États-Unis	Alternatives de médicaments opioïdes plus sûrs
Centres de traitement de la toxicomanie	14 500 installations de traitement à l'échelle nationale	Protocoles de substances à risque réduit

Centres de recherche médicale académique

Universités et institutions de recherche médicale explorant les technologies pharmaceutiques innovantes.

• Top 50 des universités de recherche avec des budgets de recherche pharmaceutique
• Financement de la recherche annuelle: 2,7 milliards de dollars d'innovation pharmaceutique
• Intérêt pour les mécanismes d'administration de drogues dissuasifs

ENSYSCE BIOSCIENCES, Inc. (ENSC) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice se terminant le 31 décembre 2023, EnsySce Biosciences a déclaré des dépenses de R&D de 4,1 millions de dollars.

Exercice fiscal	Dépenses de R&D	Pourcentage des dépenses d'exploitation totales
2023	4,1 millions de dollars	65.2%
2022	3,7 millions de dollars	62.8%

Investissements d'essais cliniques

Les coûts des essais cliniques pour EnsySce Biosciences en 2023 ont totalisé environ 2,5 millions de dollars.

• PF614 Pays Médicament Clinical Trials: 1,2 million de dollars
• Études de formulation d'opioïdes disceptimides: 0,8 million de dollars
• Recherche préclinique supplémentaire: 0,5 million de dollars

Coûts de dépôt de brevets et d'entretien

Les dépenses annuelles liées aux brevets pour 2023 étaient de 0,3 million de dollars.

Catégorie de brevet	Contrôles de dépôt	Frais de maintenance
Technologie anti-abus	$150,000	$75,000
Brevets de formulation de médicament	$100,000	$50,000

Acquisition du personnel et des talents scientifiques

Les dépenses totales du personnel pour 2023 étaient de 3,8 millions de dollars.

• Salaires du personnel scientifique: 2,5 millions de dollars
• Personnel administratif: 0,8 million de dollars
• Recrutement et formation: 0,5 million de dollars

Infrastructure technologique et maintenance en laboratoire

Les coûts de technologie et d'infrastructures de laboratoire pour 2023 étaient de 1,2 million de dollars.

Catégorie d'infrastructure	Dépenses annuelles
Équipement de laboratoire	$650,000
Infrastructure informatique	$350,000
Entretien d'installation	$200,000

ENSYSCE BIOSCIENCES, Inc. (ENSC) - Modèle d'entreprise: Strots de revenus

Frais de licence potentiels pour les technologies d'administration de médicaments

Depuis le quatrième trimestre 2023, EnsySCE Biosciences a développé des technologies de délivrance de médicaments propriétaires avec des opportunités de licence potentielles. La technologie PDS ™ (Système de dosage de précision) de la société représente un potentiel de flux de revenus clé.

Technologie	Portée de licence potentielle	Gamme de revenus estimée
Plateforme PDS ™	Livraison de médicaments pharmaceutiques	500 000 $ - 2 000 000 $ par accord de licence
Formulation dissuasive des abus	Développement de médicaments opioïdes	750 000 $ - 3 000 000 $ par accord de licence

Accords de collaboration de recherche

Ensysce Biosciences poursuit activement des partenariats de recherche collaborative avec les sociétés pharmaceutiques.

• Valeur de collaboration potentielle: 250 000 $ - 1 500 000 $ par accord
• Régers de recherche sur la recherche: Technologies dissuastiques, formulations à libération contrôlée
• Durée de l'accord typique: 12-24 mois

Futures redevances de produits pharmaceutiques

Le pipeline de développement de médicaments de la société propose des flux de redevances potentiels à partir de la commercialisation réussie de produits pharmaceutiques.

Catégorie de produits	Pourcentage de redevances potentielles	Potentiel des revenus annuels estimés
Opioïdes dissuasifs	3% - 7%	$500,000 - $5,000,000
Médicaments à libération contrôlée	2% - 5%	$250,000 - $3,000,000

Payments de jalons potentiels à partir de partenariats stratégiques

Les partenariats stratégiques offrent des opportunités de revenus supplémentaires grâce à des paiements basés sur les jalons.

• Bonus de signature de partenariat initial: 100 000 $ - 500 000 $
• Paiements d'étape de recherche: 250 000 $ - 1 000 000 $ par réussite
• Jalons d'approbation réglementaire: 500 000 $ - 2 000 000 $ par étape

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:

Product/Program	Key 2025 Milestone/Status	Regulatory/IP Status
PF614 (Abuse Deterrent)	Initiated pivotal Phase 3 trial (PF614-301) in July 2025	N/A
PF614-MPAR (Overdose Protection)	Part 1 of Phase 2 study (PF614-MPAR-102) confirmed overdose protection	FDA Breakthrough Therapy Designation
PF9001 (OUD Treatment)	Continued advancement; lead candidate selected in 2024	Notice of Allowance for composition/use patent received April 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:

Reporting Period End Date	Federal Grant Revenue (GAAP)	Notes
March 31, 2025 (Q1)	$1.3 million	Up from $0.3 million year-over-year
June 30, 2025 (Six Months)	$2.69 million
June 30, 2025 (Q2)	$1.37 million	Total Revenue for the quarter
September 30, 2025 (Q3)	$0.5 million	Down from $3.4 million in Q3 2024

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:

Event/Milestone	Date/Period	Key Metric/Data Point
PAINWeek 2025 Symposium	September 3, 2025	Approximately 400 attendees
Q3 2025 R&D Expenses	Quarter Ended September 30, 2025	$3.0 million
PF614 Phase 3 Trial Initiation	July 2025	Pivotal trial launched

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:

Customer Segment	Relevant Metric	Value/Amount	Source Context Year
Severe Pain Patients	U.S. Pain Management Market Estimate	USD 32.79 billion	2025
Severe Pain Patients	Chronic Pain Prevalence (US Adults)	20%	Current Estimate
HCPs/Specialists	PF614 Clinical Trial Phase	Phase 3	2025
Govt Agencies/Payers	Annual Cost of Opioid Abuse	$1.5 trillion	Current Estimate
Govt Agencies/Payers	Remaining NIDA MPAR Grant Funding	$9.4 million	June 30, 2025
OUD Patients (PF9001)	Estimated US OUD Population (12+)	5.9 million	2023/2024 Data
OUD Patients (PF9001)	OUD Patients Receiving MOUD Treatment	2.2 million	2024

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:

Expense Category	Q2 2025 Amount (USD)	Q3 2025 Amount (USD)
Research & Development Expenses	$1.9 million	$3.0 million
General & Administrative Expenses	$1.20 million	$1.3 million

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:

Revenue/Financing Component	Amount	Period/Date
Federal Grant Revenue	$0.5 million	Q3 2025
Initial Convertible Preferred Financing Proceeds	$4.0 million	November 2025
Potential Future Financing Tranches	Up to $16.0 million	Next 24 months
Cash and Cash Equivalents (Pre-Financing)	$1.7 million	September 30, 2025

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.