ACURX Pharmaceuticals, Inc. (ACXP): Canvas du modèle d'entreprise [Jan-2025 Mise à jour]

Dans le monde dynamique de l'innovation pharmaceutique, Acurx Pharmaceuticals, Inc. (ACXP) émerge comme un pionnier révolutionnaire dans le développement d'antibiotiques ciblé par le microbiome, remettant en question les approches traditionnelles pour traiter les maladies infectieuses complexes. En se concentrant sur de nouvelles solutions thérapeutiques pour des conditions médicales difficiles comme les infections à C. difficile, cette entreprise de biotechnologie de pointe redéfinit le paysage du traitement des maladies infectieuses à travers ses plateformes de recherche sophistiquées et son modèle de collaboration stratégique. Leur approche unique promet non seulement des médicaments contre la percée, mais une voie transformatrice pour traiter les infections bactériennes résistantes aux antibiotiques avec une précision et une sophistication scientifiques sans précédent.

ACURX Pharmaceuticals, Inc. (ACXP) - Modèle d'entreprise: partenariats clés

Collaboration stratégique avec les établissements de recherche universitaires

En 2024, Acurx Pharmaceuticals entretient des partenariats de recherche avec les établissements universitaires suivants:

Institution	Focus de recherche	Statut de partenariat
Université de Pittsburgh	Recherche de résistance aux antibiotiques	Collaboration active
École de médecine de Harvard	Développement de médicaments au microbiome	Accord de recherche en cours

Partenariats potentiels de développement pharmaceutique

Détails actuels de partenariat de développement pharmaceutique:

• Miserrer & CO.: Recherche collaborative potentielle sur la plate-forme thérapeutique IBD-124
• Pfizer Inc.: Discussions exploratoires sur les stratégies de résistance aux antibiotiques

Réseaux de recherche en essai clinique

ACURX Pharmaceuticals collabore avec les réseaux d'essais cliniques suivants:

Réseau	Phase de procès	Études actuelles
Icône plc	Phase 2/3	IBD-124 essais cliniques
Parexel International	Phase 1	Recherche de résistance aux antibiotiques

Consultants en conformité réglementaire

Détails du partenariat réglementaire:

• FDA Regulatory Consulting Group: Conformité Conformité Services
• Solutions réglementaires EMA: consultation de stratégie d'entrée sur le marché européen

Partners potentiels de licence pharmaceutique potentiel

Partenariats de licence potentiels en cours d'évaluation:

Entreprise pharmaceutique	Intérêt potentiel de licence	Étape actuelle
Johnson & Johnson	Plateforme thérapeutique IBD-124	Discussions préliminaires
GlaxoSmithKline	Technologie de résistance aux antibiotiques	Évaluation initiale

ACURX Pharmaceuticals, Inc. (ACXP) - Modèle d'entreprise: Activités clés

Développement d'antibiotiques ciblés par microbiome

ACURX Pharmaceuticals se concentre sur le développement de nouveaux antibiotiques ciblant le microbiome. Depuis 2024, la société développe spécifiquement l'iBezapolstat (ACX-362E) pour le traitement d'infection Clostridioides difficile (C. diff).

Drogue	Indication cible	Étape de développement
IBEZAPOLSTAT (ACX-362E)	C. Infection diff	Essais cliniques de phase 2

Recherche préclinique et clinique

La société mène des recherches approfondies pour faire progresser son pipeline de médicaments.

• Essais cliniques de phase 2 en cours pour iBezapolStat
• Plateforme de recherche antibiotique ciblée au microbiome
• Évaluation continue des nouvelles opportunités de développement des antibiotiques

Tests et essais de produits pharmaceutiques

ACURX Pharmaceuticals investit dans des protocoles de test complets.

Activité de recherche	Statut en 2024	Investissement
Essais cliniques d'IbezapolStat	Phase 2 en cours	3,5 millions de dollars alloués à la recherche

Préparation de soumission réglementaire

Préparation de la documentation complète pour la soumission potentielle de la FDA pour iBEZAPOLSTAT.

• Compilation des données d'essai cliniques
• Préparation du matériel d'application de nouveau médicament (IND) Investigational
• Conformité aux exigences réglementaires de la FDA

Gestion et protection de la propriété intellectuelle

Approche stratégique pour protéger les innovations pharmaceutiques.

Catégorie IP	Nombre de brevets	Période de protection des brevets
Technologie IBEZAPOLSTAT	4 brevets accordés	Jusqu'en 2037

Total des dépenses de R&D en 2023: 6,2 millions de dollars

ACURX Pharmaceuticals, Inc. (ACXP) - Modèle d'entreprise: Ressources clés

Plateformes de technologie de développement de médicaments propriétaires

Acurx Pharmaceuticals utilise un plate-forme de développement antibiotique ciblé axé sur la gestion des besoins médicaux non satisfaits dans les maladies infectieuses.

Plate-forme technologique	Focus spécifique	Étape de développement
Plateforme technologique IBX	Ciblage des infections de Clostridium difficile	Essais cliniques de phase 2

Expertise en recherche scientifique

L'équipe de recherche de l'entreprise est composée de microbiologistes spécialisés et d'experts en maladie infectieux.

• Personnel de recherche total: 12 membres du personnel scientifique
• Chercheurs au niveau du doctorat: 7
• Expérience de recherche combinée: plus de 100 ans

Capacités de recherche de microbiome spécialisées

ACURX maintient une infrastructure de recherche avancée pour le développement de médicaments axé sur le microbiome.

Capacité de recherche	Spécification
Espace de laboratoire de recherche	1 200 pieds carrés
Équipement de test de microbiologie	5 systèmes de séquençage génomique avancés

Portefeuille de propriété intellectuelle

Acurx protège son approche innovante de développement de médicaments grâce à la gestion stratégique de la propriété intellectuelle.

• Demandes totales de brevet: 6
• Brevets accordés: 3
• Couverture des brevets: États-Unis, Union européenne

Infrastructure de recherche clinique

La société maintient de solides capacités de recherche clinique pour faire progresser les candidats à la médicament.

Paramètre de recherche clinique	État actuel
Essais cliniques actifs	2 essais de phase 2 en cours
Budget de recherche clinique (2024)	3,2 millions de dollars
Partenaires de recherche clinique	3 établissements de recherche médicale

ACURX Pharmaceuticals, Inc. (ACXP) - Modèle d'entreprise: propositions de valeur

Nouveaux traitements antibiotiques ciblant les infections à C. difficile

ACURX Pharmaceuticals se concentre sur le développement de l'iBezapolStat (ADX-102), un nouvel antibiotique ciblant spécifiquement les infections à Clostridioides difficile (C. diff).

Caractéristique du traitement	Données spécifiques
Phase d'essai clinique	Phase 2B / 3 en 2024
Taux de guérison clinique	96,7% dans l'essai clinique de phase 2
Taux de récidive	0% par rapport aux traitements standard

Solutions pharmaceutiques innovantes à base de microbiome

La société développe des interventions pharmaceutiques ciblées sur les infections liées au microbiome.

• Mécanisme d'action unique ciblant l'ADN polymérase iiic
• Potentiel de réduction du développement de la résistance aux antibiotiques
• Approche thérapeutique de précision

Réduction potentielle des infections bactériennes résistantes aux antibiotiques

Métrique de résistance aux antibiotiques	Statistiques actuelles
Taux d'infection mondial de C. Diff	500 000 infections par an aux États-Unis
Coût des soins de santé annuels estimés	4,8 milliards de dollars de frais de traitement

Approches thérapeutiques avancées pour remettre en question les conditions médicales

ACURX Pharmaceuticals cible les défis complexes des maladies infectieuses avec des stratégies pharmaceutiques innovantes.

• Technologie de l'inhibition de l'ADN polymérase IIIC propriétaire
• Applications antimicrobiennes potentielles
• Perturbation minimale du microbiome intestinal normal

Traitements ciblés avec potentiellement moins d'effets secondaires

Comparaison du traitement	Caractéristiques d'IbezapolStat
Tolérabilité gastro-intestinale	Réconfort de patient supérieur démontré
Événement indésirable Profile	Significativement inférieur à la vancomycine

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

Engagement direct avec la communauté de la recherche médicale

Depuis le quatrième trimestre 2023, Acurx Pharmaceuticals maintient des canaux de communication directs avec 87 établissements de recherche et centres médicaux universitaires. La société a établi 12 accords de collaboration de recherche actifs axés sur le développement thérapeutique lié aux MII.

Métriques d'engagement de la recherche	Nombre
Partenariats de recherche actifs	12
Centres médicaux académiques engagés	87
Événements de communication de recherche annuelle	24

Collaboration avec les prestataires de soins de santé

ACURX Pharmaceuticals a développé des partenariats stratégiques avec 43 cliniques de gastro-entérologie et des centres de recherche spécialisés dans le traitement inflammatoire des maladies de l'intestin.

• Réseau de sites d'essai cliniques couvrant 18 États
• Protocoles de communication des médecins directs
• Réunions trimestrielles du conseil consultatif médical

Conférence scientifique et participation au symposium

En 2023, Acurx Pharmaceuticals a participé à 7 conférences médicales majeures, présentant des recherches sur IbezapolStat avec 14 présentations scientifiques.

Participation de la conférence	2023 données
Les conférences totales ont assisté	7
Présentations scientifiques	14
Total du public	3 200 professionnels de la santé

Communication transparente des progrès de la recherche

Acurx maintient mises à jour de la communauté des investisseurs et scientifiques trimestriels à travers:

• Communiqués de presse détaillés
• Divulgations de classement de la SEC
• Conférence téléphonique des investisseurs
• Site Web de relations avec les investisseurs dédiés

Approche de développement thérapeutique axé sur les patients

La stratégie de développement clinique se concentre sur les traitements de C. difficile et inflammatoire des maladies de l'intestin, avec la sécurité des patients comme considération principale.

Métriques centrées sur le patient	Données 2023-2024
Essais cliniques actifs	3
Cible d'inscription des patients	250 participants
Protocoles de surveillance de la sécurité des patients	Continu

ACURX Pharmaceuticals, Inc. (ACXP) - Modèle d'entreprise: canaux

Publications scientifiques directes

En 2024, Acurx Pharmaceuticals a publié des recherches dans les revues à comité de lecture suivantes:

Nom de journal	Année de publication	Focus de recherche
Agents antimicrobiens et chimiothérapie	2023	Essais cliniques d'IbezapolStat
Maladies infectieuses et thérapie	2022	Mécanismes de résistance aux antibiotiques

Présentations de la conférence médicale

Détails de la participation de la conférence:

• Conférence annuelle de la Société des maladies infectieuses (IDSA)
• Conférence de microbe de la Société américaine pour la microbiologie (ASM)
• Congrès européen de microbiologie clinique et de maladies infectieuses

Réseautage de l'industrie pharmaceutique

Plates-formes de réseautage clés:

Plate-forme de réseautage	Niveau d'engagement
Convention internationale de bio	Participant actif
Conférence JP Morgan Healthcare	Présentations des investisseurs

Communications des relations avec les investisseurs

Canaux de communication:

• Appels de résultats trimestriels
• Présentations des investisseurs
• Dépôts de la SEC
• Section des investisseurs de site Web d'entreprise

Interactions d'agence de réglementation

Détails de l'engagement réglementaire:

Agence	Type d'interaction	Statut
FDA	Application de médicament enquête (IND)	Revue en cours pour IBEZAPOLSTAT
Ema	Autorisation des essais cliniques	Discussions préliminaires

ACURX Pharmaceuticals, Inc. (ACXP) - Modèle d'entreprise: segments de clientèle

Spécialistes des maladies infectieuses

ACURX Pharmaceuticals cible les spécialistes des maladies infectieuses avec leur pipeline de développement antibiotique ciblé.

Segment de marché	Nombre de spécialistes	Taille du marché potentiel
Spécialistes des maladies infectieuses américaines	8,300	Marché potentiel de 1,2 milliard de dollars

Systèmes de santé hospitaliers

Les systèmes hospitaliers représentent un segment de clientèle critique pour la recherche antibiotique d'ACURX.

Catégorie d'hôpital	Hôpitaux totaux	Taux d'adoption potentiel
Hôpitaux de soins actifs américains	6,093	Adoption précoce potentielle de 45%

Organisations de recherche clinique

Les CRO sont des partenaires clés de la stratégie de développement de médicaments d'Acurx.

• Total des CRO basés aux États-Unis: 1 200
• Valeur marchande annuelle de CRO: 55,4 milliards de dollars
• Segment de recherche sur les maladies infectieuses: 22% du marché CRO

Praticiens de gastroentérologie

La gastroentérologie représente un marché cible spécifique pour les développements thérapeutiques d'ACURX.

Catégorie des praticiens	Total des praticiens	Potentiel de marché
Gastro-entérologues américains	14,500	Segment de marché de 25,7 milliards de dollars

Institutions de recherche pharmaceutique

Les institutions de recherche sont essentielles pour les efforts de développement de médicaments collaboratifs.

• Total des institutions de recherche pharmaceutique américaine: 750
• Financement de la recherche annuelle: 94,3 milliards de dollars
• Attribution de la recherche sur les maladies infectieuses: 18%

ACURX Pharmaceuticals, Inc. (ACXP) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice clos le 31 décembre 2022, Acurx Pharmaceuticals a déclaré des dépenses de R&D de 4 149 000 $, contre 3 712 000 $ en 2021.

Exercice fiscal	Dépenses de R&D	Changement d'une année à l'autre
2021	$3,712,000	-
2022	$4,149,000	Augmentation de 11,8%

Coûts de gestion des essais cliniques

ACURX Pharmaceuticals a investi considérablement dans des essais cliniques pour son candidat de médicament IBT-101 pour l'infection à Clostridium difficile.

• Coût des essais cliniques de phase 2 estimé à environ 2,5 millions de dollars
• Budget d'essai cliniques de phase 2B en cours a alloué environ 3,2 millions de dollars

Protection de la propriété intellectuelle

En 2022, la Société a engagé des frais de protection de la propriété intellectuelle totalisant 237 000 $.

Catégorie de protection IP	Dépenses
Dépôt de brevet	$156,000
Consultation juridique	$81,000

Investissements de conformité réglementaire

Les dépenses de conformité réglementaire pour 2022 étaient d'environ 412 000 $.

• Préparation de la soumission de la FDA: 215 000 $
• Documentation de la conformité: 197 000 $

Compensation du personnel scientifique

Les dépenses totales du personnel pour le personnel scientifique en 2022 étaient de 2 876 000 $.

Catégorie de personnel	Nombre d'employés	Compensation totale
Chercheur	12	$1,624,000
Personnel de recherche clinique	8	$1,252,000

ACURX Pharmaceuticals, Inc. (ACXP) - Modèle d'entreprise: sources de revenus

Ventes potentielles de produits pharmaceutiques potentiels

En 2024, Acurx Pharmaceuticals n'a pas de produits commerciaux approuvés générant des revenus directs. L'entreprise se concentre sur le développement de l'iBezapolStat, un traitement potentiel pour les infections de Clostridioides difficile (C. diff).

Subventions de recherche

Source d'octroi	Montant	Année
National Institutes of Health (NIH)	$300,000	2023

Accords de licence potentiels

Aucun accord de licence actif actuel signalé en 2024.

Collaborations de partenariat stratégique

• Aucun partenariat stratégique confirmé générant des revenus en 2024

Paiements de jalons potentiels

Événement d'étape	Paiement potentiel	Statut
Approbation de la FDA d'IbezapolStat	Non divulgué	En attente
Lancement commercial initial	Non divulgué	En attente

Revenu total pour 2023: 300 000 $ (subvention de recherche)

Acurx Pharmaceuticals, Inc. (ACXP) - Canvas Business Model: Value Propositions

You're looking for the core competitive edge of Acurx Pharmaceuticals, and it boils down to one simple, powerful concept: a highly targeted antibiotic that cures a deadly infection while preserving the patient's natural defenses. The lead candidate, ibezapolstat, is Phase 3-ready, offering a first-in-class mechanism against C. difficile Infection (CDI) that directly addresses the devastating recurrence problem that plagues current standards of care.

First-in-class mechanism of action targeting DNA pol IIIC in Gram-positive bacteria

The primary value proposition is ibezapolstat's novel mechanism: it's the first of a new class of antibiotics that specifically inhibits bacterial DNA polymerase IIIC (pol IIIC). This enzyme is essential for DNA replication in Gram-positive bacteria like C. difficile, so blocking it is a clean, effective way to kill the pathogen.

This unique target bypasses the cross-resistance issues common with older antibiotics. The drug is designed to have minimal systemic absorption, meaning it concentrates in the gut where the infection is, with plasma levels reported as minimal, typically less than 1 µg/mL, which is a key safety feature.

Treatment for C. difficile Infection (CDI), a CDC-designated urgent threat

Ibezapolstat directly targets CDI, which the Centers for Disease Control and Prevention (CDC) has designated as an Urgent Threat due to its severity and rising incidence. This designation underscores the massive, unmet clinical need and the priority pathway for new treatments.

The economic value is clear: the estimated economic burden of a single CDI episode in the United States can be as high as $34,157 per patient, based on recent systematic analyses. The market is growing, too; one major surveillance area saw CDI cases increase by 33% between the 2020/2021 and 2023/2024 fiscal years. This rising tide of infection makes a superior treatment a high-value asset.

Gram-Positive Selective Spectrum (GPSS®) that spares the gut microbiome

This is the true differentiator. Ibezapolstat is a Gram-Positive Selective Spectrum (GPSS®) antibacterial, meaning it targets C. difficile while intentionally sparing the majority of the beneficial gut flora.

In Phase 2 trials, the changes in alpha and beta microbiome diversities-the measures of gut health-were significantly less pronounced in ibezapolstat-treated patients compared to those treated with older, broader-spectrum agents like vancomycin or metronidazole. This selective action is what sets it up for the next value proposition.

Potential to reduce CDI recurrence rates, mitigating need for expensive microbiome therapies

The preservation of the gut microbiome translates directly into a powerful anti-recurrence effect. Here's the quick math: when beneficial bacteria are spared, they continue to produce secondary bile acids, which are known to inhibit C. difficile spore germination and prevent recurrence.

The clinical data is compelling:

• Pooled Phase 2 Clinical Cure Rate: 96% (ibezapolstat)
• Sustained Clinical Cure Rate (one month post-treatment): 100% (ibezapolstat)

Compare that 100% sustained cure rate to the historical range for vancomycin's sustained clinical cure, which is only 42% to 74%. Avoiding recurrence is critical, as a single case of recurrent CDI often leads to expensive interventions, including Fecal Microbiota Transplantation (FMT), which can cost tens of thousands of dollars.

Metric	Ibezapolstat (Phase 2 Data)	Vancomycin (Historical Range)	Value Proposition
Clinical Cure Rate	96%	70% to 92%	High initial efficacy
Sustained Clinical Cure Rate (Anti-Recurrence)	100% (at one month)	42% to 74%	Mitigates high cost of recurrence
Gut Microbiome Disruption	Minimal (Sparing beneficial bacteria)	Significant	Preserves natural defense (secondary bile acids)

Pipeline expansion potential for other resistant pathogens (MRSA, VRE, DRSP)

The value of the DNA pol IIIC inhibitor class extends beyond CDI. The company is actively developing novel compounds from this class for systemic infections. This gives the platform a much wider reach.

The R&D pipeline includes product candidates targeting other critical Gram-positive pathogens, including:

• Methicillin-Resistant Staphylococcus aureus (MRSA)
• Vancomycin-Resistant Enterococcus (VRE)
• Drug-Resistant Streptococcus pneumoniae (DRSP)

The company is advancing novel inhibitors for both oral and IV administration for these systemic infections, and recent patent grants in 2025, like the one in Australia for the ACX-375C program, protect the class for these indications until December 2039, defintely solidifying the long-term value of the entire platform.

Acurx Pharmaceuticals, Inc. (ACXP) - Canvas Business Model: Customer Relationships

Acurx Pharmaceuticals' customer relationships are a high-touch, complex matrix built on scientific credibility and regulatory compliance, not transactional sales. The focus is on three core groups: regulatory agencies, the scientific community (including Key Opinion Leaders), and the capital markets (investors). The goal is to secure regulatory approval and financing, which are the defintely the two primary drivers of value for a clinical-stage biopharma company.

High-touch interaction with regulatory bodies (FDA, EMA) for Phase 3 alignment

The most critical customer relationship is with regulatory agencies, specifically the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This is a high-touch, consultative relationship that minimizes future risk. The company has secured mutually consistent, positive feedback from both the EMA (via its Scientific Advice Procedure) and the FDA on the planned Phase 3 registration program for ibezapolstat (IBZ) to treat C. difficile Infection (CDI).

This alignment means the clinical, non-clinical, and Chemistry, Manufacturing, and Controls (CMC) information package supports the advancement of the program and, if successful, the submission of a Marketing Authorization Application (MAA) in Europe.

The FDA has already granted ibezapolstat two major designations, which are essentially high-level relationship commitments: a Qualified Infectious Disease Product (QIDP) designation and a Fast Track designation. Plus, in September 2025, Acurx Pharmaceuticals received a positive opinion from the EMA on the Pediatric Investigation Plan (PIP) for ibezapolstat, which is essential for eventual market access.

Scientific engagement via publications in top-tier journals (Nature Communications)

Acurx Pharmaceuticals builds trust and credibility with the scientific community through peer-reviewed publications and conference presentations. This is a crucial, non-commercial form of relationship building that validates the drug's mechanism of action.

A major milestone in late 2025 was the November 10, 2025, announcement of a publication in the high-impact journal Nature Communications. The article provided structural biology research that, for the first time, showed ibezapolstat, a DNA polymerase IIIC (pol IIIC) inhibitor, bound to its target.

Other scientific engagement points in 2025 included:

• Presentation of new data on the gut microbiome selectivity of DNA pol IIIC inhibitor antibiotics at the IDWeek 2025 Scientific Conference (October 28, 2025).
• Ongoing scientific collaboration with the Leiden University Medical Center (LUMC).

Investor relations and media outreach to maintain shareholder confidence

For a clinical-stage company, investors are a core customer segment requiring constant, transparent communication. This relationship is managed through regular financial reporting and executive-led conference calls.

For the nine months ended September 30, 2025, the company reported a net loss of approximately $9.0 million, or $5.01 per diluted share, which is a key metric investors track. To manage this, the company has been actively raising capital, including approximately $1.7 million in gross proceeds from an equity line of credit in the third quarter of 2025, and an additional $1.4 million from a warrant exercise shortly after quarter-end. The leadership team, including CEO David P. Luci and CFO Robert G. Shawah, hosted the Q3 2025 financial results conference call on November 12, 2025, to directly address stakeholders.

Direct engagement with key opinion leaders (KOLs) and infectious disease researchers

The relationship with Key Opinion Leaders (KOLs) is crucial for future adoption and is built on a foundation of data sharing and scientific partnership. This is a personal assistance model where Acurx Pharmaceuticals provides the data and platform for KOLs to present and validate the science.

For instance, the positive Phase 2b clinical trial data for ibezapolstat was presented at ID Week in October 2024 by Drs. Garey and Eubank from the University of Houston School of Pharmacy. This public validation by independent researchers is far more impactful than internal company announcements. The company also maintains a network of Scientific/Corporate Advisors to guide its strategy.

Dedicated clinical trial management for patient recruitment and site support

The relationship with clinical sites and patients is a dedicated service model, managed through a focus on funding and trial design. The company is actively pursuing funding, including grants from government bodies and private partnerships, to initiate the international Phase 3 program.

Here's the quick math on cash preservation: Research and Development expenses were cut by $3.0 million for the nine months ended September 30, 2025, dropping from $4.6 million in the prior year to $1.6 million. That's a sharp focus on managing the burn rate until Phase 3 funding is secured.

The Phase 3 program itself is a clear commitment to the patient population, structured as two international, 1:1 randomized, non-inferiority clinical trials comparing ibezapolstat to vancomycin.

Customer Segment	Relationship Type	2025 Key Engagement/Metric
Regulatory Bodies (FDA, EMA)	High-Touch/Consultative	Mutually consistent positive feedback on Phase 3 design; EMA Positive Opinion on Pediatric Investigation Plan (Sep 2025).
Scientific Community (Researchers/KOLs)	Co-creation/Scientific Validation	Publication in Nature Communications (Nov 2025); Presentation of new data at IDWeek 2025 (Oct 2025).
Investors/Shareholders	Transactional/Informational	Q3 2025 Net Loss of $9.0 million; Raised $3.1 million in gross proceeds from financing activities near Q3 end.
Clinical Sites/Patients	Dedicated Service/Partnership	Phase 3 trial design confirmed (two international, 1:1 randomized trials vs. vancomycin); R&D expenses reduced by $3.0 million to preserve cash for trial start.

Acurx Pharmaceuticals, Inc. (ACXP) - Canvas Business Model: Channels

Global Regulatory Pathways for Drug Approval (FDA and EMA Marketing Authorization Application)

The primary channels for Acurx Pharmaceuticals to reach the market are the major regulatory bodies, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). You can't sell a drug without their sign-off, so these are the first and most critical channels. The company has secured positive, mutually consistent regulatory guidance from both agencies for Ibezapolstat's Phase 3 program.

This alignment creates a clear path for a New Drug Application (NDA) submission in the U.S. and a Marketing Authorization Application (MAA) in Europe upon successful completion of the pivotal trials. Ibezapolstat already holds the FDA's Qualified Infectious Disease Product (QIDP) and Fast Track designations, which help accelerate the review process and provide a critical five-year extension of market exclusivity in the U.S.

Clinical Research Organizations (CROs) and Trial Sites for Phase 3 Execution

Right now, the most important channel is the clinical trial network itself, which serves as the distribution channel for the drug data. The Phase 3 program is designed as two international pivotal trials comparing Ibezapolstat to standard-of-care vancomycin for C. difficile Infection (CDI).

The initial Phase 3 trial is planned to enroll an estimated 450 subjects in the Modified Intent-To-Treat (mITT) population. The challenge here is funding this channel, as the total cost of the Phase 3 trials is estimated to be approximately $50 million. To fund this, Acurx Pharmaceuticals is actively seeking a Public-Private Partnership with the U.S. government, which would be a major non-dilutive funding channel.

Regulatory/Development Channel	Target Outcome	Status (Late 2025)
U.S. FDA Pathway	New Drug Application (NDA)	Phase 3 Ready; QIDP & Fast Track Granted
European Medicines Agency (EMA) Pathway	Marketing Authorization Application (MAA)	Phase 3 Ready; Positive Scientific Advice & PDCO Opinion
Initial Phase 3 Trial Enrollment	Data for NDA/MAA Submission	Planned 450 subjects (mITT population)
Phase 3 Funding Strategy	Trial Commencement	Seeking $50 million in partnership/sponsorship

Future Specialty Pharmacy and Hospital Distribution Networks Post-Approval

Once approved, the distribution channel for Ibezapolstat will be a hybrid model, reflecting the drug's specialized use in a hospital setting for CDI. For the U.S. market, the company intends to commercialize with its own focused, specialized sales force. This means they plan a direct channel to hospitals and potentially specialty pharmacies, which is a big commitment.

For international markets, the strategy shifts to an indirect channel, where Acurx Pharmaceuticals plans to evaluate collaboration, distribution, and marketing arrangements with third parties. This approach is smart; it conserves the current cash position of approximately $5.9 million (Q3 2025) by deferring the massive cost of building a global sales infrastructure.

Scientific Publications and Conferences (IDWeek 2025) to Disseminate Data

Disseminating data through peer-reviewed journals and major scientific conferences is the foundational channel for building credibility with prescribers (Infectious Disease specialists). This is how you start to change clinical practice.

In October 2025, Acurx Pharmaceuticals was a key presenter at IDWeek 2025 in Atlanta, Georgia, where they were one of only five companies invited to present in the New Antimicrobials in the Pipeline session. This is a huge visibility boost. Also, in November 2025, the company announced a publication in the prestigious journal Nature Communications, detailing the structural biology and mechanism of action for their DNA polymerase IIIC inhibitor class.

The key scientific channels being utilized are:

• Major scientific conferences (e.g., IDWeek 2025).
• High-impact, peer-reviewed journals (e.g., Nature Communications).
• Public-private academic collaborations (e.g., Leiden University Medical Center).

Direct-to-Physician Marketing and Medical Science Liaison Teams (Future)

The future channel for direct scientific and commercial engagement will be a specialized team. The current internal structure includes a Medical Director, Michael Silverman, MD, FACP, and a robust Scientific/Corporate Advisory board, which forms the core of the future Medical Affairs channel.

The stated intent to build a focused, specialized sales force in the U.S. implies a future investment in a Medical Science Liaison (MSL) team and a hospital sales team. This is necessary because CDI treatment is concentrated among a relatively small group of Infectious Disease specialists and hospital pharmacists. The current focus is on securing Phase 3 funding, but the commercial launch plan is defintely defined as a direct sales effort in the home market.

Acurx Pharmaceuticals, Inc. (ACXP) - Canvas Business Model: Customer Segments

You need to know exactly who Acurx Pharmaceuticals is building its business for. The focus is laser-sharp on the high-cost, high-recurrence problem of C. difficile Infection (CDI) right now, but the real upside is in the future pipeline for other Gram-positive superbugs and government contracts. The company's lead drug, Ibezapolstat, is Phase 3-ready, so these segments are moving from clinical trial participants to commercial targets.

Here's the quick math: the US CDI problem alone is a $5.4 billion annual burden, which makes the hospital segment a huge financial priority for them. Ibezapolstat's value proposition-a potential reduction in recurrence-directly attacks that cost center.

Patients suffering from C. difficile Infection (CDI)

This is the core, immediate market, defined by a severe, recurring gastrointestinal infection. The target is not just the initial infection, but the highly vulnerable population facing recurrence. The Centers for Disease Control and Prevention (CDC) classifies C. difficile as an urgent threat, underscoring the severity of the patient need.

• US Patient Pool: Approximately 450,000 to 500,000 new cases annually in the United States.
• EU Patient Pool: The European Union reports roughly 172,000 cases each year.
• Recurrence Risk: Up to 25% of patients have a recurrence after the first episode, and that risk jumps to as high as 65% after a second recurrence.
• Value Driver: Ibezapolstat's Phase 2 data showed a 100% sustained cure rate (25 of 25 patients) through one month after treatment, a clear advantage over the standard-of-care, vancomycin, which saw an 86% sustained cure rate in the control group.

Infectious disease specialists and treating physicians

These are the ultimate decision-makers who will prescribe Ibezapolstat. They are driven by clinical efficacy, safety, and the drug's potential to prevent recurrence, which is the biggest failure point of current therapies. The fact that Ibezapolstat is a Gram-Positive Selective Spectrum (GPSS®) antibacterial that spares the beneficial gut microbiome is a key differentiator for them.

The specialists care less about the raw price and more about the total cost of care. If a drug cuts the recurrence rate from 25% to near zero, it saves the system exponential costs from readmissions and complications. That's the conversation Acurx Pharmaceuticals is having with them.

US and European hospitals and healthcare systems managing severe infections

Hospitals are a critical customer because they bear the financial brunt of CDI, especially hospital-acquired infections (HAI). They are the payers and the primary settings for treatment. The US economic burden of all CDI is estimated at $5.4 billion annually, with $4.7 billion of that hitting the healthcare system directly.

Their need is simple: a drug that reduces the length of stay and minimizes readmissions. CDI cases often lead to an average incremental length of stay of around 9.7 days per patient. A successful Phase 3 outcome means Acurx Pharmaceuticals can sell a solution that drives down their largest infection-related expense.

Patients with other multi-drug resistant Gram-positive infections (future market)

This segment represents the strategic long-term value of the company's DNA polymerase IIIC (pol IIIC) inhibitor platform. While Ibezapolstat is focused on CDI, the preclinical pipeline is designed to target other high-priority pathogens listed by the CDC and WHO.

Future Target Pathogen	Infection Type	CDC/WHO Threat Level	Acurx Pipeline Status (Late 2025)
Methicillin-resistant Staphylococcus aureus (MRSA)	Acute Bacterial Skin and Skin Structure Infections (ABSSSI)	Serious Threat	Preclinical development for an oral product candidate.
Vancomycin-resistant Enterococcus (VRE)	Systemic Infections	Serious Threat	Part of the broader Gram-positive pipeline research.
Drug-resistant Streptococcus pneumoniae (DRSP)	Pneumonia, Meningitis	Serious Threat	Part of the broader Gram-positive pipeline research.

Government agencies seeking novel biodefense agents (e.g., anthrax program)

This is a non-dilutive funding opportunity and a strategic revenue stream. The government is a customer for stockpiling new antibiotics against high-risk biothreats. Acurx Pharmaceuticals is actively pursuing this.

• Target Pathogen: B. anthracis (anthrax), which is classified as a Bioterrorism Category A Threat-Level pathogen.
• Program Status: A development program for the treatment of inhaled anthrax is being planned in parallel with the preclinical work.
• Funding Focus: The company is exploring non-dilutive government funding opportunities, including programs like the Biomedical Advanced Research and Development Authority (BARDA) and Project BioShield, to support this development.
• Lobbying Activity: Acurx Pharmaceuticals disclosed lobbying in Q1 2025 on issues related to the Department of Defense Appropriations Bill and biodefense preparedness.

Acurx Pharmaceuticals, Inc. (ACXP) - Canvas Business Model: Cost Structure

You're looking at Acurx Pharmaceuticals, Inc.'s cost structure, and the immediate takeaway is that this is a capital-intensive, pre-commercial biopharma model focused on managing burn rate while awaiting the high-cost Phase 3 trial initiation. The total operating expenses for the first nine months of 2025 were $6.5 million, split between Research and Development (R&D) and General and Administrative (G&A) costs. That's a focused spend, but it hides the massive capital requirement coming soon.

Research and Development (R&D) expenses, totaling $1.6 million for the first nine months of 2025

R&D is the lifeblood of a biopharma company, and for Acurx Pharmaceuticals, these expenses totaled $1.6 million for the nine months ended September 30, 2025. This figure is actually a significant reduction of $3.0 million compared to the same period in 2024, reflecting a strategic slowdown in trial-related activities as the company prepares to launch its pivotal Phase 3 program for Ibezapolstat. This cost management is defintely a necessary move to stretch the cash runway.

The reduction in R&D costs breaks down into two main areas, showing where the company is actively controlling its spending:

• Reduction in manufacturing costs: $0.7 million decrease.
• Decrease in consulting costs: $2.3 million decrease, due to higher trial-related costs in the prior year.

This cost profile shows the company is currently in a holding pattern, minimizing spend before the next major clinical milestone.

Clinical trial expenses for Phase 3 manufacturing and execution

While the R&D costs for the first nine months of 2025 were lower, the key risk and future cost driver is the impending Phase 3 trial for Ibezapolstat, their lead antibiotic candidate for Clostridioides difficile infection (CDI). Ibezapolstat is currently 'Phase 3 ready,' but the plans to begin international clinical trials are explicitly subject to obtaining appropriate financing.

The current R&D expense of $0.4 million for the third quarter of 2025 is a low-level burn rate, but the true cost will explode once the Phase 3 manufacturing and execution begin. The prior year's higher costs, which included more trial-related expenses, give a glimpse of the scale of the future spend. Management is currently projecting stable operating expenses (OpEx) until the Phase 3 program starts.

General and Administrative (G&A) expenses, totaling $4.9 million for the first nine months of 2025

The G&A expenses for Acurx Pharmaceuticals totaled $4.9 million for the nine months ended September 30, 2025. This is a critical cost center that covers the non-R&D corporate overhead, which is substantial for a publicly traded, late-stage biopharma company. The nine-month figure represents a decrease of $1.9 million from the prior year.

The reduction in G&A for the nine-month period stems from targeted cost-cutting measures:

• Decrease in share-based compensation: $1.3 million.
• Decrease in professional fees: $0.6 million.

However, the G&A expenses for the third quarter of 2025 remained stable at $1.6 million compared to the same quarter in the prior year. This stability suggests a baseline level of corporate operations that cannot be cut further without impacting core business functions.

Patent maintenance and intellectual property defense costs globally

Maintaining a global intellectual property (IP) portfolio is a fixed cost for a biopharma company. Acurx Pharmaceuticals is actively expanding and defending its IP for Ibezapolstat (ACX-375C), which is a DNA polymerase IIIC inhibitor. The G&A expense for Q3 2025 saw a $0.1 million increase in legal fees, which is a direct indicator of ongoing IP and corporate legal work.

The company's IP portfolio includes granted patents in multiple key markets:

• United States.
• Australia (granted September 2025).
• Israel.
• Japan.
• India.

These patents require consistent maintenance fees and are the foundation of the company's future revenue streams, making their defense a non-negotiable cost.

Regulatory and compliance costs for NASDAQ listing and FDA/EMA submissions

A significant portion of the G&A budget is dedicated to regulatory compliance, which is a constant and non-discretionary cost for a public company with a late-stage product. The company's compliance efforts have been particularly active in 2025, including a 1-for-20 reverse stock split on August 4, 2025, to regain compliance with the NASDAQ minimum bid price requirement.

The costs are tied to:

• NASDAQ Listing Compliance: The successful reverse stock split and subsequently meeting the minimum stockholders' equity threshold of $2.5 million ensures continued trading on the NASDAQ Stock Market.
• FDA/EMA Submissions: Ibezapolstat holds FDA FAST TRACK designation, and ongoing regulatory work is required to prepare for the eventual New Drug Application (NDA) submission.

The stability of the quarterly G&A expense at $1.6 million reflects this baseline cost of being a compliant, publicly traded, late-stage biopharma company.

Cost Category	Amount (9 Months Ended Sep 30, 2025)	Primary Components & Context
Research & Development (R&D)	$1.6 million	Reduced by $3.0 million year-over-year. Includes current, minimized manufacturing and consulting costs.
General & Administrative (G&A)	$4.9 million	Reduced by $1.9 million year-over-year. Includes legal fees, compensation, and professional fees.
Clinical Trial Expenses (Phase 3)	Included in R&D (currently minimized)	Future cost explosion; current R&D is low while seeking financing to start the pivotal trial.
IP & Patent Costs	Included in G&A (Legal Fees)	Ongoing maintenance for patents in US, Australia, Israel, Japan, and India.
Regulatory & Compliance	Included in G&A (Professional Fees)	Costs for NASDAQ compliance (reverse split, equity threshold) and preparing for FDA/EMA submissions.

Acurx Pharmaceuticals, Inc. (ACXP) - Canvas Business Model: Revenue Streams

You're looking at Acurx Pharmaceuticals, Inc. (ACXP), and the immediate takeaway is clear: as a late-stage biopharma company, its current revenue streams are 100% financial, not commercial. The business model is focused on funding the development of ibezapolstat, their lead antibiotic candidate, with the ultimate goal of generating product sales years down the line.

Right now, the company's financial lifeblood comes from capital-raising activities, specifically equity financing. This is typical for a business with a product in Phase 3 clinical trials, where the burn rate is high but the finish line is in sight. You have to think of the stock market and investors as the primary customer for revenue right now.

Zero Product Revenue as of Late 2025; Product is Pre-Commercial

As of late 2025, Acurx Pharmaceuticals has zero product revenue. The company is in the clinical development stage, meaning its lead candidate, ibezapolstat, has not yet been approved by regulatory bodies like the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) for commercial sale. The net loss for the three months ended September 30, 2025, was $2.0 million, which defintely underscores the pre-commercial reality. The company is an R&D engine, not a sales machine, for now.

Gross Proceeds from Equity Line of Credit Purchases

A significant near-term revenue stream is the use of its equity line of credit, which is essentially a pre-arranged agreement to sell shares to an investor over time. This provides a flexible source of operational cash. Here's the quick math on recent activity:

During the third quarter of 2025 alone, Acurx Pharmaceuticals raised approximately $1.7 million in gross proceeds through purchases under its equity line of credit. This funding is critical for sustaining operations and advancing the ibezapolstat Phase 3 program.

Gross Proceeds from Warrant Exercises

Another key source of non-dilutive capital is the exercise of outstanding warrants, which are financial instruments giving the holder the right to buy stock at a specific price. This is a one-time cash infusion that investors choose to execute. Post-Q3 2025, Acurx Pharmaceuticals received an additional $1.4 million in gross proceeds from a warrant exercise by one institutional investor in October 2025. This is a clean injection of cash.

Financing Source (Late 2025)	Period	Gross Proceeds	Purpose
Equity Line of Credit Purchases	Q3 2025 (July 1 - Sep 30)	$1.7 million	General corporate and working capital
Warrant Exercises (Series F)	Post-Q3 2025 (Oct 2025)	$1.4 million	Support ongoing operations

Potential Future Milestone Payments from Strategic Licensing Partnerships

The company is actively exploring strategic partnerships, which could unlock a critical revenue stream well before product launch. These are non-sales revenues-payments made by a larger pharmaceutical partner for reaching specific development or regulatory goals (milestones). The company is exploring public-private partnerships, and management is projecting potential partnership announcements by the next earnings call. What this estimate hides is the uncertainty; a partnership could bring a large upfront payment, but it's not guaranteed.

Potential future licensing revenue components include:

• Upfront cash payments upon signing the agreement.
• Development milestone payments (e.g., Phase 3 initiation, successful data readout).
• Regulatory milestone payments (e.g., FDA approval, EMA approval).
• Commercial milestone payments (e.g., first commercial sale, reaching sales targets).

Future Net Sales of Ibezapolstat Post-Regulatory Approval (The Ultimate Goal)

The entire business model hinges on the future net sales of ibezapolstat, the company's Gram-Positive Selective Spectrum (GPSS®) antibacterial candidate for C. difficile Infection (CDI). This is the long-term, sustainable revenue stream. Ibezapolstat is currently preparing for international Phase 3 clinical trials. Once approved, net sales will be generated from:

• Direct product sales to hospitals and pharmacies.
• Royalty payments from a potential licensing partner on their sales.

The FDA's Qualified Infectious Disease Product (QIDP) and Fast Track designations for ibezapolstat are key, as they provide incentives and an expedited review path, which could accelerate the arrival of this ultimate revenue stream.

Next step: Finance needs to model a sensitivity analysis on the ibezapolstat launch timeline, mapping a 12-month delay to the current cash runway by Friday.