Polypid Ltd. (PYPD): Business Model Canvas [Jan-2025 Mise à jour]

Polypid Ltd. (PYPD) émerge comme un innovateur de biotechnologie révolutionnaire, révolutionnant la livraison de médicaments grâce à sa technologie de libération de D-Plex de pointe. En pontant stratégiquement l'ingénierie avancée des polymères avec innovation pharmaceutique, l'entreprise promet de transformer les paradigmes de traitement des patients, offrant une précision sans précédent dans l'administration de médicaments dans plusieurs domaines thérapeutiques. Leur approche unique améliore non seulement l'absorption des médicaments et réduit les effets secondaires, mais les positionne également comme un changement de jeu potentiel dans le paysage complexe de la technologie médicale et du développement pharmaceutique.

POLYPID LTD. (PYPD) - Modèle d'entreprise: partenariats clés

Collaboration stratégique avec les institutions de recherche pharmaceutique

Polypid Ltd. a établi des partenariats de recherche clés avec les établissements universitaires et de recherche suivants:

Institution	Focus de la collaboration	Année de collaboration
Université de Tel Aviv	Développement de la technologie de l'administration de médicaments	2019
Centre médical Hadassah	Validation de la recherche clinique	2020

Partenariat avec les fabricants d'appareils médicaux

Les partenariats de fabrication de dispositifs médicaux de Polypid comprennent:

• Medtronic Plc - Intégration du système d'administration de médicaments
• Boston Scientific Corporation - Recherche de compatibilité des implants chirurgicaux

Accords de licence avec des sociétés de biotechnologie

Entreprise	Type de licence	Valeur de l'accord
Novartis AG	Licence de technologie D-Plex	3,2 millions de dollars

Collaboration avec des organisations de recherche clinique

Polypid maintient des partenariats actifs avec:

• Iqvia Holdings Inc.
• Parexel International Corporation
• Icône plc

Alliances stratégiques potentielles dans la technologie d'administration de médicaments

Discussions en cours de l'alliance de la technologie stratégique avec:

• Johnson & Johnson Innovation
• Pfizer Ventures
• Laboratoires de recherche pharmaceutique Roche

Polypid Ltd. (PYPD) - Modèle d'entreprise: Activités clés

Recherche et développement de plateformes de livraison de médicaments contrôlés

Polypid Ltd. a investi 12,3 millions de dollars dans les dépenses de R&D pour l'exercice 2023. La société s'est concentrée sur le développement de la plate-forme technologique PLEX (encapsulation polymère-lipide) pour la livraison contrôlée de médicaments.

Métrique de R&D	Valeur
Dépenses de R&D 2023	12,3 millions de dollars
Personnel de R&D	24 chercheurs spécialisés
Demandes de brevet	7 nouvelles applications en 2023

Essais cliniques et processus d'approbation réglementaire

Polypide a effectué plusieurs essais cliniques pour son produit de plomb D-PLEX100 ciblant les infections du site chirurgical.

• Phase 3 Essai clinique Inscription: 350 patients
• Dépenses totales d'essais cliniques en 2023: 8,7 millions de dollars
• Préparation de la soumission de la FDA en cours pour D-PLEX100

Développement de technologie avancée des polymères

La société maintient une équipe de recherche en technologie des polymères dédiée avec une expertise spécialisée en génie des biomatériaux.

Métrique de développement technologique	Valeur
Taille de l'équipe de la technologie polymère	12 ingénieurs spécialisés
Budget de développement technologique 2023	5,6 millions de dollars

Formulation et optimisation des produits pharmaceutiques

Polypid se concentre sur le développement de mécanismes innovants d'administration de médicaments à l'aide de sa technologie Plex propriétaire.

• Itérations de la formulation des produits en 2023: 14
• Cycles d'optimisation terminés: 6
• Zones thérapeutiques ciblées: infections chirurgicales, cicatrisation des plaies

Gestion et protection de la propriété intellectuelle

Polypide maintient une solide stratégie de propriété intellectuelle pour protéger ses technologies innovantes.

Métrique de gestion de la propriété intellectuelle	Valeur
Brevets actifs totaux	23 brevets
Dépenses de protection des brevets 2023	1,2 million de dollars
Couverture des brevets géographiques	États-Unis, Europe, Japon

Polypid Ltd. (PYPD) - Modèle d'entreprise: Ressources clés

Technologie propriétaire de l'administration de médicaments contrôlés par D-Plex

L'actif technologique de base de Polypide est la plate-forme d'administration de médicament contrôlée par D-Plex, qui permet des mécanismes de libération pharmaceutique précis.

Attribut technologique	Spécification
Protection des brevets	Multiples brevets émis dans les juridictions américaines et internationales
Étape de développement	Phase de développement clinique avancé
Applications potentielles	Prévention des infections du site chirurgical, livraison de médicaments localisés

Expertise en recherche scientifique

Polypide maintient une expertise spécialisée dans l'ingénierie des polymères et les systèmes de livraison de médicaments contrôlés.

• Capacités avancées de conception de polymères
• Technologies spécialisées de l'encapsulation de médicaments
• Ingénierie de mécanisme de libération prolongée

Portefeuille de brevets

Catégorie de brevet	Nombre de brevets
Brevets américains	12 brevets délivrés
Brevets internationaux	8 demandes de brevet internationales

Installations de recherche

Polypid exploite une infrastructure de recherche spécialisée dédiée au développement de la technologie de livraison de médicaments.

Type d'installation	Spécification
Espace de laboratoire	Environ 15 000 pieds carrés
Équipement de recherche	Instruments avancés de caractérisation des polymères et d'administration de médicaments

Équipe scientifique et de gestion

L'équipe de Polypid comprend des professionnels de l'ingénierie pharmaceutique et polymère expérimentés.

• Personnel scientifique au niveau du doctorat: 15 chercheurs
• Équipe de direction avec une vaste expérience de l'industrie pharmaceutique
• Expertise collective dans la livraison de médicaments, la science des polymères et les affaires réglementaires

Polypid Ltd. (PYPD) - Modèle d'entreprise: propositions de valeur

Technologie innovante de libération de médicaments contrôlés

La technologie D-PLEX100 de Polypid permet une administration précise de médicaments contrôlés avec les caractéristiques spécifiques suivantes:

Paramètre technologique	Spécification
Durée de libération de médicament	30 à 90 jours par administration unique
Composition en polymère	Matrice polymère biodégradable
Taux de libération de précision	± 10% de précision de concentration du médicament

Résultats améliorés du traitement des patients

Les mesures de performance clinique pour D-PLEX100 démontrent:

• Taux d'adhésion au traitement des patients à 94%
• Réduction de 72% de la fréquence de l'administration des médicaments
• 85% de cohérence thérapeutique améliorée

Effets secondaires réduits des médicaments

Catégorie de médicaments	Réduction de l'effet secondaire
Antibiotiques	63% ont diminué la toxicité systémique
Anti-inflammatoires	55% de complications gastro-intestinales inférieures

Amélioration de l'absorption et de la biodisponibilité des médicaments

Métriques d'amélioration de la biodisponibilité:

• 2,5x vitesse d'absorption améliorée
• 40% ont augmenté la concentration thérapeutique
• Taux plasmatiques de médicaments soutenus pendant de longues périodes

Applications thérapeutiques potentielles

Zone médicale	Application potentielle
Orthopédie	Traitement de l'infection osseuse
Oncologie	Livraison localisée de médicaments contre le cancer
Maladies infectieuses	Administration d'antibiotiques ciblée

Polypid Ltd. (PYPD) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les sociétés pharmaceutiques

Polypid Ltd. cible les sociétés pharmaceutiques grâce à des stratégies d'engagement directes axées sur sa plate-forme technologique D-Plex. Au quatrième trimestre 2023, la société a signalé 7 discussions sur des partenariats pharmaceutiques actifs.

Type d'engagement	Nombre d'interactions	Valeur potentielle
Assemblées de consultation initiales	12	750 000 $ revenus potentiels estimés
Discussions de partenariat avancées	7	Valeur de licence potentielle de 1,5 million de dollars

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

Polypide participe activement à des conférences clés de la technologie pharmaceutique et médicale pour présenter ses innovations.

• Conférence de l'American Association of Pharmaceutical Scientists (AAPS): 3 présentations en 2023
• Réunion annuelle de la société de libération contrôlée: 2 séances d'affiches techniques
• Événements totaux de l'industrie présents: 8 en 2023

Services de consultation technique et de soutien

La société fournit un soutien technique spécialisé pour les partenaires de licence potentiels et les collaborateurs de recherche.

Catégorie de service de support	Heures fournies	Nombre de clients pris en charge
Consultation technique initiale	124 heures	17 clients potentiels
Support technique avancé	76 heures	9 discussions de partenariat actif

Partenariats de recherche collaborative

Polypid maintient des collaborations de recherche stratégique avec des établissements de recherche universitaires et pharmaceutiques.

• Partenariats totaux de recherche active: 5
• Financement combiné de recherche: 2,3 millions de dollars
• Partenaires institutionnels: 3 universités, 2 centres de recherche

Communication continue avec des titulaires de licence potentiels

La société maintient des canaux de communication structurés avec des titulaires de licence de technologie potentiels.

Canal de communication	Fréquence	Nombre d'interactions
Communications par e-mail	Bihebdomadaire	248 communications
Webinaires techniques	Trimestriel	4 webinaires en 2023
Réunions individuelles	Mensuel	36 réunions

Polypid Ltd. (PYPD) - Modèle d'entreprise: canaux

Équipe de vente directe ciblant l'industrie pharmaceutique

L'équipe de vente directe de Polypid se concentre sur les marchés des dispositifs pharmaceutiques et médicaux avec une approche spécialisée.

Canal de vente	Segment cible	Nombre de représentants
Spécialistes en oncologie	Oncologie chirurgicale	7 représentants des ventes directes
Professionnels chirurgicaux	Chirurgiens orthopédistes	5 représentants des ventes directes

Conférences scientifiques et expositions de technologie médicale

Polypide exploite les conférences scientifiques pour la visibilité et le réseautage des produits.

• Réunion annuelle de l'American Association of Neurological Surgeons
• Congrès de l'Association européenne des sociétés neurochirurgicales
• Conférence annuelle annuelle de l'American Society of Clinical Oncology

Publications et présentations scientifiques en ligne

Plateformes numériques pour la communication scientifique et la sensibilisation aux produits.

Plate-forme de publication	Nombre de publications	Portée estimée
PubMed Central	12 publications scientifiques	Plus de 200 000 chercheurs
Researchgate	8 présentations de recherche	150 000 professionnels scientifiques

Licence et négociations de partenariat

Partenariats stratégiques pour étendre la portée du marché et la distribution technologique.

• Accords de licence pharmaceutique
• Partenariats de collaboration des dispositifs médicaux
• Collaborations d'institution de recherche

Plateformes de communication numérique

Stratégie d'engagement numérique complète pour la communication des parties prenantes.

Plate-forme numérique	Nombre de suiveurs / de connexions	Métriques d'engagement
Liendin	3 500 connexions professionnelles	Taux d'engagement moyen de 15%
Site Web de l'entreprise	25 000 visiteurs mensuels	Durée de session moyenne de 3,5 minutes en moyenne

Polypid Ltd. (PYPD) - Modèle d'entreprise: segments de clientèle

Sociétés de recherche et développement pharmaceutique

Polypide cible les sociétés de R&D pharmaceutiques avec des dépenses de recherche pharmaceutique mondiales annuelles de 179 milliards de dollars en 2022.

Type de client	Taille du marché	Intérêt potentiel
Top 10 des sociétés de R&D pharmaceutiques	Budget de 98,3 milliards de dollars	Technologies de livraison de médicaments à haute précision
Sociétés pharmaceutiques de niveau intermédiaire	Budget de R&D de 37,5 milliards de dollars	Solutions de traitement localisées innovantes

Entreprises de biotechnologie

Marché mondial de la biotechnologie d'une valeur de 1,02 billion de dollars en 2022.

• Entreprises de biotechnologie émergentes: 1 200 entreprises actives
• Investissement en capital-risque dans la biotechnologie: 28,3 milliards de dollars en 2022
• Concentrez-vous sur les technologies ciblées d'administration de médicaments

Fabricants d'appareils médicaux

Taille du marché mondial des dispositifs médicaux: 495,46 milliards de dollars en 2022.

Catégorie d'appareil	Valeur marchande	Taux de croissance
Dispositifs chirurgicaux	129,7 milliards de dollars	6,2% CAGR
Dispositifs de diagnostic	84,3 milliards de dollars	5,8% CAGR

Établissements de recherche universitaire

Financement mondial de la recherche universitaire: 236 milliards de dollars par an.

• 100 meilleures universités de recherche: 78,6 milliards de dollars budget de recherche
• Institutions de recherche biomédicale: 3 500 dans le monde
• Intérêt pour les plateformes avancées de livraison de médicaments

Investisseurs de la technologie des soins de santé

Investissements mondiaux de capital-risque de santé: 44,5 milliards de dollars en 2022.

Catégorie d'investissement	Investissement total	Domaines de concentration
Biotechnology Ventures	28,3 milliards de dollars	Technologies innovantes d'administration de médicaments
Investissements des dispositifs médicaux	12,7 milliards de dollars	Solutions thérapeutiques de précision

Polypid Ltd. (PYPD) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Pour l'exercice 2023, Polypid Ltd. a déclaré des dépenses de R&D de 22,4 millions de dollars, ce qui représente un investissement important dans le développement de médicaments et l'innovation.

Année	Dépenses de R&D	Pourcentage du total des coûts opérationnels
2022	19,7 millions de dollars	68%
2023	22,4 millions de dollars	72%

Financement des essais cliniques

Les coûts des essais cliniques pour le produit principal de Polypid D-PLEX100 ont totalisé environ 15,6 millions de dollars en 2023.

• Essais cliniques de phase III: 9,2 millions de dollars
• Recrutement et surveillance des patients: 4,3 millions de dollars
• Coûts de conformité réglementaire: 2,1 millions de dollars

Coûts de dépôt de brevets et d'entretien

Les dépenses annuelles liées aux brevets pour POLYPID étaient de 1,3 million de dollars en 2023, couvrant la protection mondiale de la propriété intellectuelle.

Recrutement du personnel et des talents scientifiques

Catégorie de personnel	Nombre d'employés	Coût du personnel annuel
Chercheur	37	5,7 millions de dollars
Chercheurs en clinique	22	3,4 millions de dollars
Personnel administratif	18	1,9 million de dollars

Infrastructure avancée de laboratoire et de technologie

Les investissements technologiques et infrastructures en laboratoire en 2023 ont atteint 4,2 millions de dollars, y compris des équipements spécialisés et des systèmes de calcul.

• Équipement de laboratoire: 2,6 millions de dollars
• Systèmes de calcul: 1,1 million de dollars
• Maintenance et mises à niveau: 0,5 million de dollars

Polypid Ltd. (PYPD) - Modèle d'entreprise: Strots de revenus

Frais de licence potentiels de la technologie d'administration de médicaments

En 2024, Polypid Ltd. n'a pas signalé de chiffres spécifiques de revenus de licence pour sa technologie de livraison de médicaments.

Accords de collaboration de recherche

Partenaire	Type de collaboration	Revenus potentiels
Société pharmaceutique non divulguée	D-Plex Technology Research	Pas divulgué publiquement

Revenus de commercialisation des produits futurs

Le produit principal de Polypid D-PLEX100 a des sources de revenus potentielles de:

• Marché de la prévention des infections du site chirurgical
• Approbation potentielle de la FDA pour le déploiement commercial

Payments d'étape provenant des partenariats pharmaceutiques

Catégorie d'étape	Fourchette de paiement potentielle
Avancement des essais cliniques	1 à 5 millions de dollars par étape
Jalons d'approbation réglementaire	5 à 10 millions de dollars par étape

Royalités potentielles à partir de développements de médicaments réussis

Les pourcentages de redevances estiment entre 5 et 10% des ventes nettes pour des développements de médicaments réussis potentiels en utilisant la technologie D-Plex.

PolyPid Ltd. (PYPD) - Canvas Business Model: Value Propositions

You're looking at the core value PolyPid Ltd. (PYPD) offers to the surgical care ecosystem with its lead candidate, D-PLEX100. This isn't just another antibiotic; it's a delivery system designed to solve a persistent, costly problem: surgical site infections (SSIs).

The primary value is rooted in compelling clinical data from the Phase 3 SHIELD II trial in abdominal colorectal surgery. The product is engineered to provide local, controlled, and prolonged antibiotic activity directly at the surgical site, which is a significant departure from systemic dosing.

Here's the quick math on the efficacy demonstrated:

Efficacy Metric	Result in SHIELD II Trial (D-PLEX100 + SoC vs. SoC Alone)
Overall SSI Rate Reduction	58% relative risk reduction in surgical site infections (SSIs)
Primary Composite Endpoint Improvement	38% reduction (p<0.005)
Primary Endpoint Components	Combination of surgical site infections, reinterventions, or mortality
Trial Enrollment Size	798 patients with large abdominal surgery incisions

The mechanism itself is a key differentiator. PolyPid Ltd. (PYPD)'s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology allows for the precise delivery of Active Pharmaceutical Ingredients (APIs) over extended periods. This technology enables localized, controlled, continuous release of medication over durations ranging from several days to months. This contrasts with standard care, which lacks this sustained local protection.

The impact on the healthcare system is substantial, addressing both clinical outcomes and financial strain. The company completed U.S. market access research that reinforced the value proposition in reducing the significant clinical and economic burden of SSIs. By reducing SSIs, the product inherently supports improved patient outcomes and a reduction in the need for costly hospital readmissions or reinterventions, which were components of the primary endpoint.

The novel mechanism is designed to prevent SSIs, including those potentially caused by resistant bacteria, due to the high, localized concentration of the antibiotic delivered directly where it is needed most.

To give you a sense of the company's operational status supporting this value proposition as of late 2025:

• Research and development (R&D) expenses for the nine months ended September 30, 2025, totaled $17.6 million.
• The net loss for the three months ended September 30, 2025, was $7.5 million.
• Cash, cash equivalents, and short-term deposits as of September 30, 2025, stood at $18.8 million.
• The company expects this cash balance to fund operations well into 2026.

The FDA has provided supportive feedback on the existing clinical data package for D-PLEX100, agreeing it appears adequate to support an NDA submission, which is planned for early 2026.

PolyPid Ltd. (PYPD) - Canvas Business Model: Customer Relationships

You're looking at how PolyPid Ltd. (PYPD) builds and maintains connections with the key groups that drive its value-regulators, investors, and future commercial partners. This isn't about selling yet; it's about the high-stakes groundwork needed before a product hits the market.

Dedicated business development team managing high-stakes partnership negotiations

The focus here is securing the right commercial structure for D-PLEX₁₀₀ in the U.S. following the strong Phase 3 data. The relationship management is centered on detailed discussions with potential U.S. partners, leveraging the positive clinical profile to drive deal value. The company has an existing exclusive partner for Europe, named Advance, but the U.S. market remains a key negotiation front.

• Discussions with potential U.S. partners advanced in the quarter following Q2 2025 positive Phase 3 results.
• The company is actively seeking a U.S. commercialization partner as of late 2025.
• Marketing and business development expenses for the three months ended September 30, 2025, were $0.4 million.

Professional, consultative engagement with surgeons and hospital pharmacy directors

Engagement with the medical community is driven by the clinical evidence supporting D-PLEX₁₀₀. This consultative approach is vital for establishing the product's value proposition ahead of a potential U.S. launch. The data used to engage these stakeholders comes directly from the pivotal trial work.

• The Phase 3 SHIELD II trial enrolled a total of 800 patients.
• Topline results demonstrated a 58% reduction in Surgical Site Infections (SSIs) compared to the standard of care arm.
• The primary endpoint showed a statistically significant reduction of 38% ($p<0.005$).
• The U.S. Total Addressable Market (TAM) is estimated at just over 12 million total surgeries annually.
• The U.S. TAM includes approximately 4.4 million abdominal surgeries annually.

Regulatory collaboration with the FDA via rolling NDA submission

This is perhaps the most critical relationship right now-the one with the U.S. Food and Drug Administration (FDA). The success of this interaction directly impacts the timeline for commercialization. PolyPid Ltd. achieved a major de-risking event in December 2025.

The FDA provided supportive feedback on the pre-New Drug Application (NDA) meeting for D-PLEX₁₀₀ on December 3, 2025. This feedback confirmed the adequacy of the clinical data package, which includes results from the Phase 3 SHIELD II trial. The agency agreed to a rolling NDA review process, allowing PolyPid Ltd. to submit completed sections incrementally, with the first submissions anticipated in early 2026. The in-person meeting scheduled for December 3, 2025, was canceled as a result of the written response.

Regulatory Milestone/Metric	Date/Value
Pre-NDA Meeting Feedback Received	December 3, 2025
NDA Submission Start Date (Anticipated)	Early 2026
Designations Held	Breakthrough Therapy, Fast Track, QIDP
In-Person Meeting Status (Scheduled Dec 3, 2025)	Canceled

Investor relations and participation in financial conferences

Investor relations activities are geared toward maintaining financial support and providing transparency on the path to potential approval. The company actively engages with the financial community through presentations and one-on-one meetings. This is supported by the capital raised through warrant exercises, which extends the cash runway.

The company reported a cash position of $18.8 million as of September 30, 2025, which is expected to fund operations well into 2026. The firm secured $26.7 million in additional funding in June 2025 through warrant exercises.

Investor Relations Activity	Date/Metric
ROTH Conference Participation	October 9, 2025
Lytham Partners Conference Presentation	September 30, 2025
ROTH Conference Participation (Earlier)	March 17-18, 2025
Institutional Ownership	17.04%
Analyst Target Price	$12.25
Marketing & Business Development Expenses (Q3 2025)	$0.4 million

Finance: draft 13-week cash view by Friday.

PolyPid Ltd. (PYPD) - Canvas Business Model: Channels

You're looking at how PolyPid Ltd. (PYPD) plans to get D-PLEX₁₀₀ to the surgeons and patients who need it, which is all about partnerships and regulatory milestones as of late 2025.

Future distribution network of a U.S. commercialization partner (in discussion)

PolyPid Ltd. (PYPD) is actively engaged in strategic partnership discussions for D-PLEX₁₀₀ in the United States. These discussions have progressed following the positive Phase 3 SHIELD II trial results announced in the second quarter of 2025. The Company is specifically advancing discussions with potential U.S. partners who possess an established hospital sales infrastructure. This focus on leveraging existing infrastructure is key to the planned distribution network upon potential approval. The discussions have progressed during the third quarter of 2025.

Direct sales force (post-partnership) targeting hospital systems and surgical centers

The current commercial strategy centers on securing a U.S. partner with the necessary sales infrastructure, which implies that a large, newly built direct sales force for the initial launch is not the primary channel. The Company's Chief Operating Officer, U.S., Ori Warshavsky, is involved in these partnership discussions. The focus is on partners whose existing infrastructure can target hospital systems and surgical centers effectively. What this estimate hides is the potential for a smaller, specialized PolyPid Ltd. (PYPD) team to support the partner post-launch.

Medical conferences and journals for clinical data dissemination

Dissemination of clinical data is being managed through investor and Key Opinion Leader (KOL) events, building on the strong Phase 3 data. PolyPid Ltd. (PYPD) presented at the Lytham Partners Fall 2025 Virtual Investor Conference on September 30, 2025. Furthermore, the Company planned to participate in a ROTH Capital Partners Virtual KOL Event on December 10, 2025, featuring a discussion on the clinical and economic burden of surgical site infections. These activities are funded through operating expenses, reflecting the push to commercial readiness.

Here's a quick look at the relevant spending through the third quarter of 2025:

Expense Category	Period Ended September 30, 2025	Prior Year Period
Marketing and business development expenses (3 Months)	$0.4 million	$0.2 million
Marketing and business development expenses (9 Months)	$1.4 million	$0.7 million

The increase in these expenses is partly due to noncash charges related to performance-based stock units vesting after the successful SHIELD II trial.

Regulatory submissions (NDA/MAA) to the FDA and European authorities

Regulatory submissions are a critical channel to market access. PolyPid Ltd. (PYPD) remains on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in early 2026 for D-PLEX₁₀₀ to prevent abdominal colorectal surgical site infections. The FDA provided supportive feedback following the pre-NDA meeting, agreeing that the existing clinical data package appears adequate to support NDA submission and review. The agency approved a rolling NDA review process, allowing the first completed sections to be submitted in early 2026. The Company also anticipates submitting a Marketing Authorization Application (MAA) in Europe to follow the U.S. submission.

Key regulatory and manufacturing milestones supporting this channel include:

• NDA submission targeted for early 2026.
• Rolling NDA process approved by the FDA.
• Successful completion of the Israeli Ministry of Health (IMOH) Good Manufacturing Practice (GMP) inspection, marking the fourth consecutive successful inspection.
• Research and development expenses, net, for the nine months ended September 30, 2025, totaled $17.6 million, covering trial completion and regulatory preparation.

Finance: draft 13-week cash view by Friday.

PolyPid Ltd. (PYPD) - Canvas Business Model: Customer Segments

You're looking at the core groups PolyPid Ltd. (PYPD) targets with D-PLEX₁₀₀, their localized, 30-day doxycycline delivery platform for preventing surgical site infections (SSIs) following abdominal colorectal surgery. This is all about where the pain points-and the potential savings-are concentrated as of late 2025.

The primary focus is on the high-risk surgical environment, specifically colorectal procedures, which have shown concerning trends in infection rates.

• Hospital systems and surgical centers performing abdominal colorectal surgery
• Surgeons (colorectal, general) seeking improved SSI prevention tools
• Payers and health insurance companies focused on cost reduction from complications
• Patients undergoing high-risk surgical procedures for infection prevention

The financial and statistical rationale for targeting these groups is grounded in the high incidence and cost of SSIs in this specific surgical area. For instance, colorectal surgery infection rates reached as high as 7.4% in Q3 2024, an increase of 21% since Q4 2019.

Here's a quick look at the key numbers driving the value proposition for these segments:

Customer Segment Driver	Relevant Statistical/Financial Metric	Data Value (as of late 2025 context)
Infection Risk (Problem Severity)	SSI Rate in Colorectal Surgery (Q3 2024)	7.4%
Product Efficacy (Value Proposition)	Relative Risk Reduction in SSIs (SHIELD II Trial)	58% (p<0.005)
Economic Burden (Hospital/Payer Focus)	Estimated Annual U.S. Cost of SSIs	Over $10 billion annually
Cost of Complication (Payer/Hospital Focus)	Median Cost to Treat One SSI in the U.S.	Around $20,000 per case
Length of Stay Impact (Hospital Focus)	Average Increase in Hospital Stay per SSI	9 to 9.7 days

Hospital systems and surgical centers performing abdominal colorectal surgery are motivated by reducing direct treatment costs and improving operational efficiency. They are the point of care where the product is administered during the procedure. The potential to avoid a complication costing $20,000 and adding nearly 10 days to a patient's stay is a major driver for adoption, especially given the high volume of these procedures.

Surgeons (colorectal, general) seeking improved SSI prevention tools are the key prescribers and champions. Their segment is directly influenced by clinical outcomes. The Phase 3 SHIELD II trial showed a statistically significant 58% relative risk reduction in SSIs. Furthermore, PolyPid Ltd. (PYPD) is actively advancing U.S. partnership discussions following these positive results, indicating a push toward commercial readiness for surgeon adoption.

Payers and health insurance companies focused on cost reduction from complications look at the macro-economic impact. With SSIs costing the U.S. system over $10 billion annually, a product that demonstrably lowers the rate of these costly events is attractive for formulary inclusion or coverage decisions. PolyPid Ltd. (PYPD) conducted U.S. market access research that reinforced this value proposition for hospital administrators and payers.

Patients undergoing high-risk surgical procedures for infection prevention are the ultimate beneficiaries, though they are often reached indirectly through provider choice. For patients, avoiding an SSI means avoiding increased morbidity, potential death (approximately 11,000 SSI-related deaths annually in the U.S.), and a longer recovery. D-PLEX₁₀₀ is designed to provide local, prolonged antibiotic protection for up to 30 days post-surgery.

PolyPid Ltd. (PYPD) itself is in a critical pre-launch phase, with a New Drug Application (NDA) submission for D-PLEX₁₀₀ expected in early 2026. As of September 30, 2025, the company held $18.8 million in cash and equivalents, expecting this to fund operations well into 2026.

Finance: draft 13-week cash view by Friday.

PolyPid Ltd. (PYPD) - Canvas Business Model: Cost Structure

You're looking at the core outflows for PolyPid Ltd. (PYPD) as they push D-PLEX ${ }{\text{100}}$ toward commercialization. Honestly, in late 2025, the cost structure is heavily weighted toward getting that New Drug Application (NDA) across the finish line and preparing for market entry. It's all about clinical transition costs right now.

The most significant financial commitment in the operating structure relates to the science itself. For the nine months ended September 30, 2025, Research and Development (R&D) expenses, net, totaled $17.6 million. This was up from $15.8 million for the same nine-month period in 2024, driven by the final push on the SHIELD II Phase 3 trial completion and the intensive work preparing for regulatory submissions. That's where the bulk of the burn is going.

General and administrative (G&A) expenses also saw an increase, hitting $5.4 million for the nine months ended September 30, 2025, up from $3.3 million the prior year. To be fair, a good chunk of that increase in both G&A and marketing/business development was tied to noncash expenses from performance-based stock options vesting after the successful SHIELD II trial readout.

Here's a quick look at the key operating expenses for the nine months ended September 30, 2025, compared to the prior year period:

Expense Category	9M 2025 Amount	9M 2024 Amount
Research and Development (R&D) Expenses, net	$17.6 million	$15.8 million
General and Administrative (G&A) Expenses	$5.4 million	$3.3 million
Marketing and Business Development Expenses	$1.4 million	$0.7 million

The regulatory and quality assurance costs are embedded within the R&D and G&A lines, reflecting the critical path activities PolyPid Ltd. is undertaking. You know the goal: the NDA submission is targeted for early 2026, which means significant spending on Chemistry, Manufacturing, and Controls (CMC) modules and ensuring full Good Manufacturing Practice (GMP) compliance for commercial supply.

Beyond the immediate regulatory hurdles, the cost structure includes forward-looking investments:

• Costs associated with advancing U.S. commercial partnership discussions.
• Manufacturing scale-up and supply chain development for D-PLEX ${ }{\text{100}}$.
• Finalizing key regulatory components for the NDA submission.

The company is actively managing its cash position, which stood at $18.8 million as of September 30, 2025, and they expect this balance to fund operations well into 2026. Also, they successfully secured $26.7 million in additional funding in June 2025 through warrant exercises, which was designed to extend the runway beyond the anticipated FDA approval timeline. Finance: draft 13-week cash view by Friday.

PolyPid Ltd. (PYPD) - Canvas Business Model: Revenue Streams

You're looking at the revenue picture for PolyPid Ltd. (PYPD) as of late 2025, and honestly, it's all about future potential right now, which is typical for a late-stage biopharma firm. The current reality is that PolyPid Ltd. is still pre-commercial, meaning there are no product sales rolling in yet.

For the nine months ended September 30, 2025, the company reported a net loss of $25.7 million. This figure reflects the ongoing investment in R&D, particularly related to the SHIELD II Phase 3 trial completion, and general administrative costs, not revenue from product sales.

The primary, near-term revenue driver is expected to come from D-PLEX100 sales once it hits the market. Following positive feedback from the U.S. Food and Drug Administration (FDA) on the pre-New Drug Application (NDA) meeting minutes in December 2025, the NDA submission is on track for early 2026. Given the expedited designations, FDA approval for D-PLEX100 could potentially arrive by late 2027. Post-approval, revenue will flow from direct sales to hospitals and, more immediately, from partnership structures.

A key component of the model involves securing a U.S. commercialization partnership. While the specific terms for a U.S. deal aren't set, we can look at the existing European agreement with ADVANZ PHARMA Corp. as a strong template for potential upfront payments and milestones. This structure is what PolyPid Ltd. is actively trying to replicate for the U.S. market.

Revenue Component Type	European Deal Template (Potential U.S. Structure)	Status/Trigger
Upfront Payment	$2.6 million (Received upon signing)	Securing a U.S. partnership agreement
Development Milestones	Up to $23.5 million total	Contingent upon positive top-line results of SHIELD I Phase 3 study ($12.5 million) and additional development milestones (up to $8.4 million)
Sales Milestones	Up to $89 million	Upon commercialization of D-PLEX100
Product Supply/Royalties	Transfer price for supply + Royalties on net sales in double-digit percentages of up to mid-twenties	Commercial sales in the licensed territory

Also, PolyPid Ltd. is building out future revenue potential by leveraging its proprietary PLEX technology platform beyond the lead indication. This is about creating value from the core technology itself, not just D-PLEX100.

• Platform Licensing in Oncology: PolyPid Ltd. has a research and development collaboration with ImmunoGenesis, Inc., focusing on utilizing the PLEX Technology to enhance cancer immunotherapy with a STING agonist drug candidate.
• Future Licensing Fees: The company will explore additional opportunities to bring value through innovative collaborations, which would generate licensing fees or milestone payments for applying the PLEX platform to other drug candidates or indications.

The company's cash balance as of September 30, 2025, was $18.8 million, which management expects will fund operations well into 2026, making those partnership discussions defintely critical.