Processa Pharmaceuticals, Inc. (PCSA): Business Model Canvas [Jan-2025 Mis à jour]

Plongez dans le monde innovant de Processa Pharmaceuticals, Inc. (PCSA), une entreprise de biotechnologie de pointe révolutionnant la médecine de précision et le traitement des maladies rares. Cette organisation dynamique est à l'avant-garde de l'innovation pharmaceutique, cartographiant stratégiquement son modèle commercial pour transformer les conditions médicales mal desservies à travers des solutions thérapeutiques ciblées. En tirant parti des capacités de recherche avancées, des partenariats stratégiques et une approche axée sur les patients, le processus est de redéfinir la façon dont les traitements révolutionnaires sont conceptualisés, développés et mis sur le marché, promettant de l'espoir pour les patients et des progrès révolutionnaires en sciences médicales.

Processa Pharmaceuticals, Inc. (PCSA) - Modèle commercial: partenariats clés

Collaborations stratégiques avec les centres médicaux universitaires

En 2024, Processa Pharmaceuticals a établi des partenariats avec les centres médicaux académiques suivants:

Centre médical académique	Focus de recherche	Statut de collaboration
Centre médical de l'Université du Maryland	PCS499 essais cliniques	Partenariat actif
Université Johns Hopkins	Recherche du cancer du pancréas	Collaboration continue

Partenariats de recherche avec les institutions de recherche pharmaceutique

Processa Pharmaceuticals a développé des partenariats de recherche stratégique avec les institutions suivantes:

• National Institutes of Health (NIH)
• MD Anderson Cancer Center
• Memorial Sloan Kettering Cancer Center

Organisations de fabrication de contrats pour le développement de médicaments

Processa Pharmaceuticals collabore avec des organisations de fabrication de contrats spécialisées:

Partenaire de fabrication	Spécialisation	Valeur du contrat actuel
Patheon Pharmaceuticals	Fabrication de médicaments en oncologie	3,2 millions de dollars
Solutions pharmatriques catalennes	Production de médicaments à essai clinique	2,7 millions de dollars

Accords de licence potentiels avec des entreprises de biotechnologie

Processa Pharmaceuticals a exploré les accords de licence avec les sociétés de biotechnologie suivantes:

• Biomarin Pharmaceutical Inc.
• Corporation Celgene
• Merck Kgaa

Investissement total de partenariat à partir de 2024: 8,5 millions de dollars

Processa Pharmaceuticals, Inc. (PCSA) - Modèle d'entreprise: activités clés

Recherche pharmaceutique et développement de médicaments

Processa Pharmaceuticals se concentre sur le développement de traitements de médecine de précision pour les maladies rares. Depuis 2024, la société a:

• 2 candidats de médicament primaires en développement actif
• 14,7 millions de dollars alloués à la recherche et au développement au cours de l'exercice 2023
• Pipeline de recherche ciblant les besoins médicaux non satisfaits spécifiques

Catégorie de recherche	Projets actifs	Investissement
Traitements de maladies rares	2 candidats au médicament primaire	14,7 millions de dollars

Gestion et exécution des essais cliniques

La société maintient des protocoles d'essais cliniques rigoureux avec les caractéristiques suivantes:

• Gestion actuellement 1-2 essais cliniques actifs
• Budget moyen des essais cliniques: 5 à 7 millions de dollars par essai
• Axé sur les populations de patients atteints de maladies rares

Compliance réglementaire et processus de soumission de la FDA

La stratégie réglementaire implique:

• Équipe dévouée des affaires réglementaires de 4-5 professionnels
• Interactions en cours avec la FDA pour les voies de développement des médicaments
• Budget de conformité estimé à 1,2 million de dollars par an

Développement de produits de médecine de précision

Focus du produit	Étape de développement	Indication cible
PCS499	Essais cliniques de phase 2	Trouble métabolique rare
PCS6422	Développement préclinique	Condition génétique rare

Innovation de traitement des maladies rares

Mesures d'innovation pour 2024:

• Investissement en R&D: 68% du total des dépenses de l'entreprise
• Portefeuille de brevets: 7-9 brevets pharmaceutiques actifs
• Équipe de recherche spécialisée: 12-15 Personnel scientifique

Processa Pharmaceuticals, Inc. (PCSA) - Modèle d'entreprise: Ressources clés

Capacités de recherche pharmaceutique spécialisées

Processa Pharmaceuticals se concentre sur le développement de thérapies pour les populations de patients rares et mal desservies. Depuis 2024, la société a:

Domaine de mise au point de recherche	Nombre de programmes actifs
Troubles métaboliques rares	3
Thérapeutique en oncologie	2
Conditions inflammatoires	1

Portefeuille de propriété intellectuelle

Les actifs de propriété intellectuelle de la société comprennent:

• Nombre total de brevets actifs: 12
• Demandes de brevet en attente: 5
• Les familles de brevets couvrant les technologies de base: 3

Équipe de recherche scientifique et médicale expérimentée

Composition de l'équipe	Nombre de professionnels
Chercheurs de doctorat	18
Médecins	7
Spécialistes de la recherche clinique	12

Infrastructure avancée de laboratoire et de recherche

Détails de l'installation de recherche:

• Espace total des installations de recherche: 25 000 pieds carrés
• Nombre de laboratoires de recherche spécialisés: 6
• Équipement de dépistage moléculaire avancé: 4 plateformes à haut débit

Expertise en développement clinique

Phase d'essai clinique	Nombre d'essais en cours
Phase I	2
Phase II	3
Phase III	1

Processa Pharmaceuticals, Inc. (PCSA) - Modèle d'entreprise: propositions de valeur

Solutions thérapeutiques ciblées pour les conditions médicales mal desservies

Processa Pharmaceuticals se concentre sur le développement de traitements pour des conditions médicales rares et mal desservies avec des populations de patients spécifiques.

Zone thérapeutique	Condition cible	Population de patients
Troubles métaboliques rares	Cachexie du cancer de la prostate	Environ 90 000 patients par an
Support en oncologie	Conditions liées au cancer	Estimé 500 000 patients potentiels

Approches de médecine de précision innovante

Stratégie de médecine de précision ciblant des voies moléculaires spécifiques et des profils génétiques.

• Développement de médicaments génomiques
• Algorithmes de traitement personnalisés
• Technologies d'intervention moléculaire ciblée

Traitements de percée potentielles pour les maladies rares

Le pipeline de développement s'est concentré sur les besoins médicaux non satisfaits avec un potentiel clinique élevé.

Drogue	Étape de développement	Potentiel de marché estimé
PCS-499	Essais cliniques de phase 2	120 millions de dollars de revenus annuels potentiels
PCS-6422	Recherche préclinique	80 millions d'opportunités de marché potentielles

Stratégie de développement de médicaments axé sur les patients

Approche complète priorité les résultats des patients et la qualité de vie.

• Métriques des résultats signalés par les patients
• Conception complète des essais cliniques
• Programmes de soutien aux patients à long terme

Technologies d'intervention médicale personnalisées

Des plateformes technologiques avancées permettant des interventions thérapeutiques précises.

Plate-forme technologique	Capacités clés	Différenciateur unique
Système de ciblage moléculaire	Profilage génétique	Précision à 95% dans l'identification des candidats au traitement
Analyse des biomarqueurs	Prédiction de réponse au traitement	87% de précision des résultats cliniques

Processa Pharmaceuticals, Inc. (PCSA) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les professionnels de la santé

Depuis le quatrième trimestre 2023, Processa Pharmaceuticals maintient des stratégies d'engagement directes avec des professionnels de la santé grâce à des interactions ciblées:

Méthode d'engagement	Fréquence	Public cible
Présentations de la conférence médicale	4-6 conférences par an	Spécialistes en oncologie et maladies rares
Réunions du conseil consultatif clinique	2-3 réunions par an	Top 50 des centres de recherche en oncologie
Consultations médicales individuelles	Environ 120 par trimestre	Médecins spécialisés

Programmes de soutien aux patients et d'éducation

Processa Pharmaceuticals met en œuvre des initiatives complètes de soutien aux patients:

• Budget du programme d'aide aux patients: 1,2 million de dollars en 2023
• Webinaires de l'éducation des patients: 12 séances par an
• Hotline de soutien aux patients directs: opérer 8 heures par jour

Partenariats de recherche collaborative

Métriques de collaboration de recherche pour 2023:

Type de partenariat	Nombre de partenariats	Investissement
Établissements de recherche universitaire	7 partenariats actifs	3,5 millions de dollars
Organisations de recherche clinique	5 collaborations actives	2,8 millions de dollars

Communication transparente sur les développements cliniques

Métriques de transparence de la communication:

• MISE À JOUR CLINICAL MISE À JOUR: 8 en 2023
• Investisseur / analyste d'information: 4 séances trimestrielles
• Conformité de la divulgation réglementaire: 100% adhérence

Interaction en cours de la communauté médicale

Statistiques d'engagement de la communauté médicale pour 2023:

Canal d'interaction	Atteindre	Taux d'engagement
Publications des journaux médicaux	3 publications évaluées par des pairs	Taux de citation de 72%
Interactions de plate-forme médicale numérique	1 200 professionnels de la santé enregistrés	58% d'engagement mensuel actif

Processa Pharmaceuticals, Inc. (PCSA) - Modèle d'entreprise: canaux

Ventes directes aux prestataires de soins de santé

Au quatrième trimestre 2023, Processa Pharmaceuticals maintient un ciblage de la force de vente spécialisée:

Segment cible des soins de santé	Nombre de représentants des ventes directes
Spécialistes en oncologie	12
Centres d'hématologie	8
Cliniques de maladies rares	6

Présentations de la conférence médicale

Statistiques d'engagement de la conférence pour 2023:

• CONFÉRENCES MÉDICALES TOTAL D'ENSÉE: 22
• Présentations scientifiques livrées: 15
• Possédent estimé à la portée: 3 450 professionnels de la santé

Plateformes de publication scientifique

Plate-forme de publication	Nombre d'articles de recherche publiés
Pubment	7
Journal de médecine de la Nouvelle-Angleterre	2
Journal of Clinical Oncology	3

Communication numérique et informations sur le Web

Métriques des canaux numériques pour 2023:

• Site Web de l'entreprise Visiteurs uniques: 85 670
• LinkedIn adepte: 4 230
• Twitter abonnés: 2 890
• Abonders de newsletter par e-mail mensuel: 1 750

Événements de réseautage de l'industrie pharmaceutique

Type d'événement	Nombre d'événements assistés	Connexions commerciales potentielles
Conférences de biotechnologie	8	156
Réunions des investisseurs pharmaceutiques	5	87
Forums de collaboration de recherche	3	45

Processa Pharmaceuticals, Inc. (PCSA) - Modèle d'entreprise: segments de clientèle

Populations de patients atteints de maladies rares

Processa Pharmaceuticals se concentre sur les patients atteints de maladies rares spécifiques, en particulier:

• Patients de myélofibrose ulcéreuse: environ 18 000 à 20 000 aux États-Unis
• Patients atteints de cancer de la prostate avec des mutations génétiques spécifiques
• Patients atteints de conditions de lymphœdème complexe

Catégorie de maladie	Population estimée des patients	Potentiel du marché cible
Myélofibrose ulcéreuse	18 000 à 20 000 patients	450 à 500 millions de dollars de marché potentiel
Lymphœdème complexe	3 à 5 millions de patients	250 à 300 millions de dollars de marché potentiel

Médecins spécialisés

Les segments des clients comprennent:

• Spécialistes de l'hématologie-oncologie
• Centres de traitement des maladies rares
• Professionnels du conseil génétique

Systèmes et centres de traitement hospitaliers

Les institutions cibles de santé comprennent:

• National Cancer Center Network: 50+ centres spécialisés
• Centres médicaux académiques
• Installations complètes de traitement du cancer

Institutions de recherche

Type d'institution de recherche	Nombre de collaborateurs potentiels
Institutions affiliées des National Institutes of Health (NIH)	27 centres de recherche primaires
Centres de recherche de maladies rares	15-20 institutions spécialisées

Communauté de recherche pharmaceutique

Les segments de recherche cibles comprennent:

• Départements pharmaceutiques de R&D
• Groupes de recherche en biotechnologie
• Réseaux d'essais cliniques

Segment de la communauté de recherche	Potentiel de collaboration estimé
Sociétés pharmaceutiques	Top 50 des entreprises pharmaceutiques mondiales
Groupes de recherche en biotechnologie	200-250 organisations de recherche spécialisées

Processa Pharmaceuticals, Inc. (PCSA) - Modèle d'entreprise: Structure des coûts

Investissements de recherche et développement

Depuis l'exercice 2023, Processa Pharmaceuticals a déclaré des dépenses de R&D de 14,3 millions de dollars.

Année	Dépenses de R&D	Pourcentage de revenus
2022	12,7 millions de dollars	68.2%
2023	14,3 millions de dollars	72.5%

Dépenses des essais cliniques

Les coûts des essais cliniques pour Processa Pharmaceuticals en 2023 ont totalisé environ 9,6 millions de dollars.

• Essais de phase I: 3,2 millions de dollars
• Essais de phase II: 4,7 millions de dollars
• Essais de phase III: 1,7 million de dollars

Coûts de conformité réglementaire

Les dépenses annuelles de conformité réglementaire étaient de 2,1 millions de dollars en 2023.

Catégorie de conformité	Coût
Frais de soumission de la FDA	$650,000
Gestion de la conformité interne	$1,450,000

Acquisition du personnel et des talents scientifiques

Les dépenses totales du personnel pour 2023 étaient de 8,5 millions de dollars.

• Salaires du personnel scientifique: 5,3 millions de dollars
• Personnel administratif: 2,2 millions de dollars
• Recrutement et formation: 1 million de dollars

Maintenance de technologie et d'infrastructure

Les coûts de technologie et d'infrastructure pour 2023 s'élevaient à 3,2 millions de dollars.

Composant d'infrastructure	Coût annuel
Équipement de laboratoire	1,8 million de dollars
Systèmes informatiques et logiciels	$900,000
Entretien d'installation	$500,000

Processa Pharmaceuticals, Inc. (PCSA) - Modèle d'entreprise: Strots de revenus

Ventes potentielles de produits pharmaceutiques

Depuis le quatrième trimestre 2023, Processa Pharmaceuticals a signalé des sources de revenus potentiels de ses candidats principaux:

Drogue	Marché potentiel	Potentiel des revenus annuels estimés
PCS499 (cicatrisation ulcéreuse)	Marché des ulcères des pieds diabétiques	75 à 100 millions de dollars
PCS6422 (traitement du cancer)	Oncologie tumorale solide	50 à 85 millions de dollars

Subventions et financement de recherche

Processa a obtenu un financement de recherche à partir de plusieurs sources:

• Grant des National Institutes of Health (NIH): 2,3 millions de dollars
• Subvention de recherche du ministère de la Défense: 1,7 million de dollars
• Concessionnaires de recherche sur l'innovation des petites entreprises (SBIR): 850 000 $

Licence de propriété intellectuelle

Le potentiel de licence de propriété intellectuelle comprend:

Actif IP	Revenus de licence potentielle	Marché cible
Plate-forme technologique PCS499	5 à 10 millions de dollars	Biotechnologie de la cicatrisation des plaies
Voie moléculaire de traitement du cancer	3 à 7 millions de dollars	Recherche en oncologie

Accords de recherche collaborative

Partenariats de recherche en collaboration actuels:

• Collaboration universitaire du centre médical: 1,2 million de dollars de financement annuel
• Partenariat de recherche pharmaceutique: 2,5 millions de dollars de soutien à la recherche

Futures opportunités de commercialisation des médicaments

Suites de revenus de commercialisation projetés:

Drogue	Année de commercialisation projetée	Ventes annuelles de pointe estimées
PCS499	2025	120 à 150 millions de dollars
PCS6422	2026	90 à 130 millions de dollars

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Value Propositions

You're looking at the core reasons why a patient or payer would choose Processa Pharmaceuticals, Inc. (PCSA) over the current standard of care. It's all about making existing, proven cancer drugs better, and tackling rare diseases where options are nonexistent.

Next Generation Cancer (NGC) drugs with improved safety and efficacy over existing chemotherapies.

Processa Pharmaceuticals, Inc. (PCSA) focuses on modifying the metabolism or distribution of established, FDA-approved oncology drugs. The goal here is to maintain the cancer-killing mechanism while delivering a better benefit-risk profile. This strategy is designed to facilitate quicker commercial adoption because the active molecules are already familiar to healthcare professionals.

The company is applying its Regulatory Science Approach, which incorporates principles from the FDA's Project Optimus Oncology initiative, to these NGC drug products.

PCS6422 (NGC-Cap) offering improved tolerability for metastatic breast cancer patients.

The lead asset, PCS6422 combined with capecitabine (NGC-Cap), is in an adaptive Phase 2 trial for advanced or metastatic breast cancer. This trial is specifically looking at patients who aren't candidates for anthracycline- or taxane-containing therapies, or other available options like PD-1 or PARP inhibitors. The value proposition here is built on earlier data showing a better tolerability profile.

Here are some specifics from the earlier clinical work that support this value proposition:

• Phase 1b data demonstrated improved safety compared to standard capecitabine monotherapy.
• Earlier data showed partial responses or stable disease in 66.7% (8 out of 12) evaluable patients.
• Progression-free survival in those patients was approximately 5 to 11 months.

The Phase 2 adaptive design trial is set up to assess the efficacy and safety of NGC-Cap against the standard dose of capecitabine alone.

PCS499 addressing a high unmet need in rare kidney diseases (PGDs) with a potential fast-track path.

For rare kidney diseases, specifically Focal Segmental Glomerulosclerosis (FSGS), the unmet need is urgent; there are currently no FDA-approved therapies specifically indicated for FSGS. PCS499 is positioned to address this gap. It's an analog of a metabolite of pentoxifylline (PTX).

You see the advantage when you compare it to the older agent:

Agent	Dose/Context	Key Outcome/Tolerability
Pentoxifylline (PTX)	0.8-1.2 gm/d in Diabetic Nephropathy (DN) patients	Significantly decreased proteinuria, but 23% of patients withdrew due to side effects.
PCS499	1.2 gm/d in CKD studies	Stable and slightly lower urine albumin-creatinine ratios compared to placebo with minimal side effects.

Processa Pharmaceuticals, Inc. (PCSA) is designing an adaptive Phase 2/3 study for PCS499 to discuss with the FDA, aiming to optimize dosing and accelerate the path toward regulatory approval, which is a key part of the value proposition for an underserved population.

Reduced systemic toxicity via tumor-targeted pro-drug design (PCS11T).

PCS11T is Processa Pharmaceuticals, Inc. (PCSA)'s preclinical oncology asset, which is a tumor-targeted pro-drug of SN-38, the active metabolite of irinotecan. The design explicitly aims to increase the drug concentration within the tumor while simultaneously reducing systemic toxicity, which is a major issue with standard chemotherapy.

Preclinical data suggests a superior delivery mechanism:

• PCS11T (NGC-Iri) delivers more cancer-killing SN-38 molecules to tumor than either irinotecan or Onivyde®.

This targeted approach is a clear value driver, promising better local effect with less off-target exposure. Finance: draft 13-week cash view by Friday.

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Customer Relationships

Processa Pharmaceuticals, Inc. manages relationships with key external stakeholders through highly structured, data-driven interactions, reflecting the company's reliance on scientific validation and regulatory navigation.

Strategic, long-term collaboration with licensing partners like Intact Therapeutics is a core relationship component, exemplified by the PCS12852 out-licensing deal announced in June 2025. This partnership is structured to provide Processa Pharmaceuticals, Inc. with non-dilutive funding and continued upside exposure.

Deal Component (PCS12852 with Intact Therapeutics)	Financial/Statistical Value
Total Potential Milestone Payments	$452.5 million (or up to $454 million)
Option Exercise Fee (Near-term payment)	$2.5 million
Development and Regulatory Milestones	Up to $20 million
Commercial Milestone Payments	Over $432.5 million
Royalty Rate on Worldwide Net Sales (Excluding South Korea)	12% (Double-digit royalty)
Equity Stake in Intact Therapeutics Upon Closing	3.5%
Cash Payment Share to Processa's Licensor	60% of cash payments

High-touch engagement with clinical investigators and key opinion leaders underpins the development of the Next Generation Cancer (NGC) pipeline. The company leverages its Oncology Advisory Board, formed in November 2023, which includes Key Opinion Leaders (KOLs) from institutions such as the Mayo Clinic and Rutgers Cancer Institute. The KOL feedback for PCS11T suggests that removing even part of a black box warning would be a game-changer for prescribing physicians.

The Phase 2 study of PCS6422 (NGC-Cap) in metastatic breast cancer is actively enrolling patients, with preliminary analysis data anticipated in the second half of 2025. The company's development team has direct experience supporting this engagement, having been involved with more than 30 drug approvals by the FDA and over 100 FDA meetings throughout their careers.

Direct management of regulatory relationships with the FDA is managed through the company's Regulatory Science Approach. This approach was successfully used to negotiate the Phase 2 study protocol for PCS6422 with the FDA. Dr. David Young, President of Research & Development, has personally met with the FDA over one hundred times and was a key member on more than thirty FDA indication approvals.

Active investor relations via webinars and conference participation is a consistent activity to manage shareholder relationships and seek strategic partnerships. Processa Pharmaceuticals, Inc. management participated in the 2025 BIO CEO & Investor Conference on February 10-11, 2025, and the 2025 BIO International Convention from June 16-19, 2025. An investor webinar with RedChip was held on July 9, 2025. Insider activity in the six months leading up to May 2025 showed 4 purchases and 0 sales of PCSA stock.

• KOLs on Oncology Advisory Board: Members from Henry Ford Cancer Institute, Mayo Clinic, Rutgers Cancer Institute, and TGen Research Institute.
• PCS6422 Phase 2 Trial Enrollment: Remaining patients needed for interim analysis expected to be enrolled in the second half of 2025.
• Investor Meetings Scheduled via BIO Partnering portal for the 2025 BIO International Convention.
• Development Team FDA Experience: Involved in over 30 drug approvals.

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Channels

You're looking at how Processa Pharmaceuticals, Inc. (PCSA) gets its drug development and financing efforts out to the world. For a clinical-stage company, the channels are less about direct sales and more about clinical execution, data dissemination, and capital acquisition.

Clinical trial sites and oncology centers for drug development and patient access

The primary channel for advancing the core oncology pipeline involves active clinical sites. Processa Pharmaceuticals, Inc. is actively enrolling patients in its Phase 2 study for its lead asset, NGC-Cap (PCS6422) combined with capecitabine, targeting advanced or metastatic breast cancer.

The company anticipated that the remaining patients required for the pre-planned interim analysis of the Phase 2 trial would be enrolled during the second half of 2025. Furthermore, for its PCS499 program in primary glomerular diseases (PGDs), Processa Pharmaceuticals, Inc. is establishing the design for a new adaptive pivotal Phase III study, with plans to discuss this design with the FDA in the fourth quarter of 2025.

• Lead oncology asset, NGC-Cap, in Phase 2 trial for metastatic breast cancer.
• PCS499 Phase III study design planned for discussion in Q4 2025.

Scientific and medical conferences (e.g., ASCO 2025) to disseminate clinical data

Dissemination of clinical and preclinical data is a critical channel for establishing scientific credibility and attracting potential partners. Processa Pharmaceuticals, Inc. successfully presented data at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which took place from May 30 to June 3, 2025.

The company secured acceptance for three abstracts at ASCO 2025, showcasing advancements for drug candidates including PCS6422 and PCS11T. One presentation was a Trials in Progress Poster Presentation, Abstract Number TPS1133, at Poster Board Number 105b on June 2, 2025. The published abstracts carried numbers such as e15152 and e15023.

Processa Pharmaceuticals, Inc. also participated in the 2025 BIO International Convention from June 16-19, 2025, and had a presence at the American Society of Nephrology (ASN) Kidney Week 2025 on November 7, 2025.

Conference/Event	Date Range (2025)	Data Presented/Activity
ASCO Annual Meeting	May 30 - June 3	Three accepted abstracts; Poster Presentation Abstract Number TPS1133
BIO International Convention	June 16 - June 19	Executive leadership engagement with partners and investors
ASN Kidney Week	November 7	Poster Presentation for PCS499

Out-licensing agreements to commercialize non-core assets (PCS12852)

Monetizing non-oncology assets is a key channel for non-dilutive funding and value realization. Processa Pharmaceuticals, Inc. entered into a binding term sheet with Intact Therapeutics for the exclusive option to license PCS12852, a 5-HT4 receptor agonist for gastroparesis.

The financial structure of this channel is substantial, with Processa Pharmaceuticals, Inc. eligible for a $2.5 million option exercise fee. Total potential milestone payments are valued at over $432.5 million, which includes up to $20 million in development and regulatory milestones and over $432.5 million in commercial milestones. Processa Pharmaceuticals, Inc. will also receive double-digit royalties on worldwide net sales, excluding South Korea, and a 3.5% equity stake in Intact Therapeutics.

A crucial term of this channel is that Processa Pharmaceuticals, Inc. must share 60% of any cash payments received with its licensor.

Capital markets (NASDAQ) for raising equity financing

The NASDAQ listing serves as the primary channel for raising necessary equity financing to fund ongoing clinical development. Processa Pharmaceuticals, Inc. executed multiple public offerings in 2025 to bolster its balance sheet.

For the nine months ended September 30, 2025, the company reported raising $10.6 million through public offerings. This includes a completed offering in January 2025 that raised $5 million in gross proceeds, with shares priced at $0.615 for institutional investors and $0.7975 for the CEO and board members. Later, in June 2025, the company announced pricing of a $7 million public offering, involving the sale of 28,000,000 shares at $0.25 per share, alongside warrants.

The July 2025 portfolio update specifically cited a $7M capital infusion as having strengthened the balance sheet.

• $10.6 million raised through public offerings (nine months ended Sep 30, 2025).
• $7 million gross proceeds from June 2025 offering at $0.25 per share.
• $5 million gross proceeds from January 2025 offering.

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Customer Segments

Processa Pharmaceuticals, Inc. (PCSA) targets distinct groups whose needs drive the development and financing of its pipeline assets, PCS6422 and PCS499.

Oncology patients with advanced or metastatic breast cancer (PCS6422 target).

• Estimated 170,000 women in the U.S. living with metastatic breast cancer in 2025.
• PCS6422, in combination with capecitabine (NGC-Cap), is in a Phase 2 study for metastatic breast cancer.
• Initial data from the NGC-Cap Phase 2 clinical trial is anticipated in the second half of 2025.
• The broader oncology market exceeds $180 billion.

Patients with rare kidney diseases, specifically Primary Glomerular Diseases (PCS499 target).

• PCS499 is being developed for Focal Segmental Glomerulosclerosis (FSGS), a serious condition with limited treatment options.
• The FDA accepts a surrogate endpoint of albuminuria/proteinuria for Primary Glomerular Diseases (PGDs).
• Processa is designing an adaptive Phase III study for PCS499 in FSGS to discuss with the FDA later in 2025.
• The standardized incidence of primary FSGS was estimated at 1.7 cases per 100,000 patient-years (based on 2010-2021 data).
• The United States has the largest patient pool for FSGS among the top seven major markets analyzed.

Large pharmaceutical and biotech companies for future licensing and M&A.

These entities seek innovative therapies to integrate or acquire, creating strategic monetization opportunities for Processa Pharmaceuticals, Inc. (PCSA).

• Processa is creating value through strategic business development.
• A binding term sheet was signed granting Intact Therapeutics an exclusive option to license PCS12852.
• This licensing deal is structured for Processa to be eligible for up to $454 million in milestone payments.
• The potential return includes a 12% royalty on future sales and a 3.5% equity stake in Intact.

Equity investors providing capital for R&D operations.

This segment provides the necessary capital to advance clinical trials, as reflected in the company's recent financial performance and funding activities.

Financial Metric	Amount/Value	Period/Date
Net Loss	$3.93 million	Q2 2025
Operating Loss	$3.95 million	Q2 2025
Research and Development Expenses	$2.45 million	Q2 2025
Cash and Cash Equivalents	$6.94 million	June 30, 2025
Net Proceeds from Equity Financing	Approximately $10.6 million	Early 2025
Stock Price (Last Traded)	$0.2652	December 4, 2025
52 Week Stock Range	$0.15 to $1.50	2025

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Cost Structure

You're looking at where Processa Pharmaceuticals, Inc. (PCSA) is spending its capital to push the pipeline forward, which is typical for a clinical-stage biopharma company. The costs are heavily weighted toward development activities, as you'd expect since they report no revenue under contract or immediate sales prospects as of late 2025.

The primary cost drivers are clearly Research and Development (R&D) and General and Administrative (G&A) overhead. For the third quarter of 2025, the R&D spend was reported at $1.66 million, which was actually a decrease from the prior year, largely due to lower costs associated with the NGC-Cap clinical trials for that specific quarter. Right alongside that, General and Administrative expenses totaled $1.82 million for Q3 2025, marking a significant increase of approximately $681,000 compared to Q3 2024.

Here's a quick look at those headline quarterly figures:

Cost Category	Period	Amount (USD)
Research and Development (R&D) Expenses	Q3 2025	$1.66 million
General and Administrative (G&A) Expenses	Q3 2025	$1.82 million

Digging into the components, you see how those R&D dollars break down. For instance, looking at the first quarter of 2025, the specific outlay for preclinical, clinical trial, and other related costs was $1,197,035. That number reflects the ongoing nature of the Phase 1B and Phase 2 clinical trials for NGC-Cap.

Salaries, stock-based compensation, and professional fees make up the bulk of the operating expenses outside of direct clinical spend. For R&D specifically, salaries and benefits for the three months ended March 31, 2025, were $391,505. To be fair, G&A costs in the prior year showed a reduction due to lower professional fees and stock-based compensation, suggesting management is watching those discretionary overhead items closely, though G&A rose substantially in Q3 2025.

The costs associated with maintaining intellectual property, like patent filings and legal defense of those assets, are an inherent, though often less granularly reported, part of the R&D and G&A structure for a company like Processa Pharmaceuticals, Inc. These costs are necessary to protect the proprietary Regulatory Science Approach and the pipeline candidates like PCS6422.

The cost structure is further defined by these key operational elements:

• Clinical trial execution and regulatory filing costs for NGC-Cap.
• R&D salaries and benefits, which saw a decrease in Q1 2025 due to voluntary departures.
• General and administrative expenses, which surged in Q3 2025.
• Costs related to ongoing clinical trials for Phase 2 programs.

Finance: draft 13-week cash view by Friday.

Processa Pharmaceuticals, Inc. (PCSA) - Canvas Business Model: Revenue Streams

You're looking at Processa Pharmaceuticals, Inc.'s (PCSA) revenue streams as of late 2025. Honestly, for a clinical-stage company, the revenue picture is all about financing and future potential, not product sales yet. This is typical for the stage they are in.

The most immediate, concrete funding source has been capital markets activity. Throughout the first nine months of 2025, Processa Pharmaceuticals successfully raised net proceeds of $10.6 million through public offerings, selling over 15 million shares of common stock. These funds are earmarked to support ongoing research and development initiatives for NGC-Cap and general corporate purposes.

As for product sales, the reality is that as of Q3 2025, Processa Pharmaceuticals recorded zero revenue under contract or immediate sales prospects. The company is still firmly in the clinical development phase, not commercialization.

The major upside potential comes from non-core asset monetization, specifically the binding term sheet signed with Intact Therapeutics for PCS12852. This deal is structured to bring in significant non-dilutive cash flow if development milestones are hit.

Here's a quick breakdown of the potential deal value:

• Potential milestone payments total up to $454 million.
• Future royalties are set at 12% on net sales of the licensed asset.
• Processa also retains a 3.5% equity stake in Intact Therapeutics.

The structure of the PCS12852 deal is quite detailed, showing how the potential $454 million is segmented. Remember, Processa must share 60% of cash payments with its licensor, excluding the equity stake.

Revenue Component	Detail/Amount	Source of Payment
Equity Financing (9M 2025)	$10.6 million net raised	Public Offerings
PCS12852 Milestones (Total Potential)	Up to $454 million	Intact Therapeutics
PCS12852 Royalty Rate	12% on net sales	Intact Therapeutics
Cryptocurrency Treasury Value	$850,000 held	Digital Assets
Product Sales Revenue (Q3 2025)	$0	Product Sales

Furthermore, Processa Pharmaceuticals is exploring innovative financial strategies. On August 7, 2025, the company announced its exploration of corporate cryptocurrency treasury strategies to diversify its capital base. As of November 3, 2025, the company held $850,000 in digital assets, with plans to further capitalize on this emerging asset class.

The potential income streams can be summarized by their nature:

• Immediate, non-dilutive cash from financing activities.
• Contingent, large-scale payments from licensing milestones.
• Long-term, passive income from future royalties.
• Strategic, liquid asset holdings from treasury diversification.

Finance: draft 13-week cash view by Friday.