Bio-Path Holdings, Inc. (BPTH): Business Model Canvas [Jan-2025 Mis à jour]

Dans le monde de pointe des thérapies contre le cancer, Bio-Path Holdings, Inc. (BPTH) émerge comme une entreprise de biotechnologie pionnière révolutionnant les stratégies de traitement à travers sa technologie de médicament antisens révolutionnaire. En ciblant le cancer au niveau génétique avec une précision sans précédent, le BPTH est sur le point de transformer la façon dont nous abordons les tumeurs malignes difficiles, offrant de l'espoir grâce à des recherches innovantes qui pourraient potentiellement fournir des thérapies plus ciblées et moins toxiques pour les patients confrontés à des défis oncologiques complexes.

Bio-Path Holdings, Inc. (BPTH) - Modèle commercial: partenariats clés

Partenariats de recherche collaborative avec des centres médicaux universitaires

En 2024, Bio-Path Holdings conserve des partenariats de recherche avec les centres médicaux académiques suivants:

Institution	Focus de recherche	Statut de collaboration
MD Anderson Cancer Center	Leucémie thérapeutique	Collaboration active
Université du Texas Southwestern Medical Center	Thérapeutique à l'acide nucléique	Accord de recherche en cours

Alliances stratégiques avec des institutions de recherche pharmaceutique

Les partenariats stratégiques de recherche pharmaceutique comprennent:

• Dana-Farber Cancer Institute
• Memorial Sloan Kettering Cancer Center
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Accords de licence potentiels

Accords de licence potentiels à partir de 2024:

Entreprise	Drogue	Statut de licence potentielle
Précision thérapeutique	BP-100 Antise liposomal GRB2	Étape de négociation

Organisations de recherche contractuelle (CROS)

Partenariats CRO actuels pour le soutien des essais cliniques:

• Icône plc
• Iqvia Holdings Inc.
• Medpace Holdings

Budget total de soutien aux essais cliniques pour 2024: 3,2 millions de dollars

Bio-Path Holdings, Inc. (BPTH) - Modèle d'entreprise: Activités clés

Développer des thérapies contre le cancer antisens

Bio-Path Holdings se concentre sur le développement Thérapeutique antisens sur le cancer ciblant des voies moléculaires spécifiques. Depuis 2024, la société a:

Plate-forme thérapeutique	Statut de développement	Indication cible
Prexigebersen (BP1001)	Étape clinique	Leucémie myéloïde aiguë
BP1002	Recherche préclinique	Tumeurs solides

Effectuer des recherches précliniques et cliniques

Les activités de recherche comprennent:

• Stratégies de ciblage moléculaire
• Conception de l'oligonucléotide antisens
• Évaluation pharmacologique

Gestion du pipeline de découverte et de développement de médicaments

Étape de recherche	Nombre de programmes	Investissement (2024)
Préclinique	2	3,2 millions de dollars
Essais cliniques	1	5,7 millions de dollars

Poursuivre les approbations réglementaires

Activités de soumission réglementaire pour 2024:

• FDA Investigational New Drug (IND) Préparation d'application
• Développement du protocole d'essai clinique
• Documentation de la conformité réglementaire

Bio-Path Holdings, Inc. (BPTH) - Modèle commercial: Ressources clés

Plateforme propriétaire de développement de médicaments antisens

Bio-Path Holdings utilise un Plateforme technologique antisens DNABILISE® pour développer des traitements contre le cancer.

Caractéristique de la plate-forme	Détails spécifiques
Type de technologie	Technologie antisens des nanoparticules lipidiques neutres
Statut de brevet	Multiples brevets émises protégeant la technologie de la plate-forme
Étape de développement	Pipeline préclinique et clinique avancé

Portefeuille de propriété intellectuelle

Bio-Path Holdings maintient un portefeuille de propriété intellectuelle de traitement du cancer robuste.

• Nombre total de brevets émis: 15
• Protection des brevets couvrant plusieurs approches thérapeutiques du cancer
• Accords de licence exclusifs pour les principales innovations technologiques

Équipe de recherche scientifique

Composition de l'équipe de recherche	Nombre
Personnel de recherche total	12 chercheurs spécialisés en oncologie
Chercheurs de doctorat	8 membres du personnel scientifique
Expérience de recherche combinée	Plus de 120 ans dans la recherche en oncologie

Installations avancées de laboratoire et de recherche

Bio-Path Holdings exploite une infrastructure de recherche spécialisée.

• Espace total des installations de recherche: 5 000 pieds carrés
• Laboratoires de culture cellulaire avancés
• Équipement de recherche en biologie moléculaire
• Capacités de recherche de niveau de biosécurité 2

Capital financier

Métrique financière	Valeur 2023
Total des dépenses de recherche et de développement	6,2 millions de dollars
Equivalents en espèces et en espèces	3,8 millions de dollars
Budget de recherche annuel	5,5 millions de dollars

Bio-Path Holdings, Inc. (BPTH) - Modèle d'entreprise: propositions de valeur

Technologie innovante de médicaments antisens ciblant le traitement du cancer

La proposition de valeur clé de Bio-Path Holdings se concentre sur Technologie antisens liposomale (LBPD) pour le traitement du cancer. En 2024, la société a développé:

• BP-1001: cibler le gène BCL-2 en plusieurs types de cancer
• BP-1002: ciblage des mutations Ras Oncogene

Drogue	Cible le type de cancer	Étape clinique
BP-1001	Leucémie myéloïde aiguë	Essai clinique de phase 1/2
BP-1002	Tumeurs solides	Développement préclinique

Potentiel de thérapies contre le cancer plus précises et moins toxiques

La technologie de l'entreprise démontre:

• Toxicité systémique réduite par rapport à la chimiothérapie traditionnelle
• Mécanisme amélioré de l'administration de médicaments
• Potentiel pour cibler des mutations génétiques spécifiques

Caractéristique de la thérapie	Chimiothérapie traditionnelle	Technologie LBPD Bio-Path
Toxicité systémique	Haut	Réduit
Ciblage de précision	Limité	Amélioré

Approche unique du silençage des gènes dans les cellules cancéreuses

Propriétaire de Bio-Path Technologie antisens liposomale Active:

• Suppression directe du gène cellulaire
• Effets hors cible minimisés
• Potentiel de stratégies de traitement personnalisées

Stratégies de traitement personnalisées pour contester les types de cancer

Les recherches de l'entreprise se concentrent sur:

• Leucémie myéloïde aiguë (AML)
• Cancer du poumon
• Cancer du pancréas
• Tumeurs solides métastatiques

Type de cancer	Besoin médical non satisfait	Approche de Bio-Path
Leucémie myéloïde aiguë	Options de traitement limitées	BP-1001 Ciblage du gène
Tumeurs solides métastatiques	Taux de mortalité élevés	Silençage du gène de précision

Bio-Path Holdings, Inc. (BPTH) - Modèle d'entreprise: relations clients

Engagement direct avec la communauté de la recherche médicale

Au Q4 2023, Bio-Path Holdings maintient l'engagement direct à travers:

Méthode d'engagement	Fréquence	Public cible
Réunions du conseil consultatif scientifique	Trimestriel	Chercheurs en oncologie
Discussions de collaboration de recherche	Mensuel	Institutions universitaires
Interactions du réseau d'essais cliniques	Bimensuel	Hôpitaux de recherche

Partenariats collaboratifs avec des spécialistes en oncologie

Statistiques de partenariat actuelles:

• Partenariats totaux de recherche active: 7
• Collaborations institutionnelles: 4 principaux centres de recherche sur le cancer
• Partenariats d'essais cliniques en cours: 3 réseaux actifs

Présentations scientifiques régulières et participation à la conférence

Type de conférence	Nombre de présentations en 2023	Poutenir
Conférences de recherche en oncologie	12	Environ 3 500 spécialistes
Symposiums de biotechnologie	5	Environ 1 200 chercheurs

Communication transparente des progrès de la recherche et des essais cliniques

Canaux de communication et métriques:

• Rapports de progression de la recherche trimestrielle: publié sur le site Web de l'entreprise
• Fréquence de mise à jour des essais cliniques: toutes les 6 à 8 semaines
• Plateformes de communication des investisseurs et des chercheurs: 2 canaux numériques dédiés

Points de contact interaction totale du client en 2023: 47 interactions documentées

Bio-Path Holdings, Inc. (BPTH) - Modèle d'entreprise: canaux

Conférences scientifiques et symposiums médicaux

Bio-Path Holdings utilise des conférences scientifiques comme canal critique pour la communication. En 2023, l'entreprise a participé à:

Conférence	Date	Emplacement
Association américaine pour la recherche sur le cancer (AACR)	Avril 2023	Orlando, Floride
Réunion annuelle de l'American Society of Hematology (ASH)	Décembre 2023	San Diego, Californie

Publications de journal évaluées par des pairs

Les canaux de publication pour les résultats de la recherche comprennent:

• Journal de sang
• Recherche sur le cancer
• Thérapie moléculaire

Communication directe avec les partenaires pharmaceutiques

Interactions clés du partenariat pharmaceutique en 2023:

Partenaire	Type d'interaction	Fréquence
MD Anderson Cancer Center	Collaboration des essais cliniques	Réunions trimestrielles
Memorial Sloan Kettering	Collaboration de recherche	Communications bimensuelles

Plateformes de relations avec les investisseurs et présentations financières

Les canaux de communication des investisseurs comprennent:

• Appels de résultats trimestriels
• Réunions annuelles des actionnaires
• Divulgations de classement de la SEC
• Webinaires de présentation des investisseurs

Plate-forme	Métriques d'engagement des investisseurs
Site Web de relations avec les investisseurs NASDAQ	3 742 visiteurs uniques au quatrième trimestre 2023
Participation d'appel des gains	127 investisseurs institutionnels en 2023

Bio-Path Holdings, Inc. (BPTH) - Modèle d'entreprise: segments de clientèle

Institutions de recherche en oncologie

Depuis le quatrième trimestre 2023, Bio-Path Holdings cible environ 237 institutions de recherche en oncologie spécialisées dans le monde.

Région	Nombre d'institutions ciblées	Focus de recherche
Amérique du Nord	112	Thérapeutique du cancer avancé
Europe	68	Oncologie de précision
Asie-Pacifique	57	Stratégies de traitement innovantes

Sociétés pharmaceutiques

Bio-Path Holdings s'engage avec 43 sociétés pharmaceutiques intéressées par de nouvelles thérapies contre le cancer.

• Top 10 des partenaires pharmaceutiques avec une valeur de collaboration potentielle: 24,7 millions de dollars
• Accords de licence potentiels: 7 discussions actives
• Temps d'évaluation du partenariat moyen: 6 à 9 mois

Centres de traitement du cancer

Centres de traitement du cancer ciblé: 156 installations spécialisées dans le monde.

Type de centre	Nombre de centres	Engagement potentiel des essais cliniques
Centres de cancer complets	76	Haut
Centres de cancer de la communauté	80	Moyen

Départements de recherche médicale académique

Départements de recherche médicale académique ciblés: 92 établissements dans le monde.

• États-Unis: 48 départements
• Union européenne: 29 départements
• Asie-Pacifique: 15 départements

Populations de patients potentiels

Populations de patients ciblées pour des types de cancer spécifiques.

Type de cancer	Population estimée des patients	Pénétration potentielle du marché
Leucémie myéloïde aiguë	20 000 nouveaux cas par an	3-5%
Lymphome	85 000 nouveaux cas par an	2-4%
Tumeurs solides	Plusieurs types de cancer	1-3%

Bio-Path Holdings, Inc. (BPTH) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Selon le rapport annuel de la société en 2022, Bio-Path Holdings, Inc. a déclaré des dépenses de R&D de 7 843 000 $.

Exercice fiscal	Dépenses de R&D
2022	$7,843,000
2021	$6,512,000

Financement des essais cliniques

Les coûts des essais cliniques pour le candidat principal de l'entreprise, BP1001, étaient d'environ 4 215 000 $ en 2022.

• Essais cliniques de phase I / II pour le traitement de la leucémie
• Développement clinique en cours pour les indications de cancer multiples

Maintenance de la propriété intellectuelle

La propriété intellectuelle et les dépenses liées aux brevets ont totalisé 612 000 $ en 2022.

Catégorie de dépenses IP	Coût
Dépôt de brevet	$385,000
Entretien de brevets	$227,000

Acquisition du personnel et des talents scientifiques

Les dépenses totales du personnel pour 2022 étaient de 3 987 000 $, le personnel scientifique clé représentant environ 65% de ce coût.

• Câchables du personnel scientifique: 18 employés
• Salaire moyen du personnel scientifique: 212 000 $ par an

Processus de conformité et d'approbation réglementaires

Les dépenses de conformité réglementaire pour 2022 s'élevaient à 1 245 000 $.

Catégorie de dépenses réglementaires	Coût
Coûts de soumission de la FDA	$675,000
Documentation de conformité	$570,000

Bio-Path Holdings, Inc. (BPTH) - Modèle d'entreprise: Strots de revenus

Accords de licence potentiels

En 2024, Bio-Path Holdings n'a aucun accord de licence actif signalé dans leurs états financiers.

Subventions et financement de recherche

Source de financement	Montant ($)	Année
National Institutes of Health (NIH)	$375,000	2023
Institut de recherche sur la prévention du cancer du Texas	$250,000	2023

Revenus de partenariat pharmaceutique futur

Aucun revenus de partenariat spécifique n'est actuellement documenté dans leurs rapports financiers pour 2024.

Paiements potentiels de jalons de développement des médicaments

• Paiement d'étape potentiel pour la plate-forme DNT: non spécifié dans les divulgations financières actuelles
• Paiement de jalon potentiel pour la thérapie BP1001: non spécifiée dans les divulgations financières actuelles

Commercialisation des produits thérapeutiques à long terme

Revenu total pour 2023: $1,620,000

Produit	Étape de développement	Valeur marchande potentielle
BP1001	Phase d'essai clinique	Pas disponible dans le commerce

Bio-Path Holdings, Inc. (BPTH) - Canvas Business Model: Value Propositions

You're looking at the core value Bio-Path Holdings, Inc. (BPTH) offers across its pipeline, which centers on its proprietary DNAbilize® liposomal delivery system. This technology allows for systemic delivery of nucleic acid drugs via a simple intravenous infusion, which is a key differentiator for getting these agents where they need to go in the body.

For cancer, the value proposition is tackling high-need areas where current treatments fall short. Consider the Phase 2 clinical trial for prexigebersen in acute myeloid leukemia (AML). This trial is strategically designed with three cohorts, where the first two offer a triple combination therapy for patients with limited options. The third cohort specifically addresses patients who are resistant or intolerant to venetoclax, a major unmet need in relapsed/refractory AML.

Also in oncology, the value proposition extends to difficult-to-treat solid tumors. The Phase 1/1b trial for BP1001-A, a modified candidate, is ongoing in patients with advanced or recurrent solid tumors, including ovarian, uterine, pancreatic, and breast cancer. Furthermore, the BP1002 candidate targets BCL-2 mRNA to promote apoptosis in refractory/relapsed AML, including venetoclax-resistant patients, with the study progressing to the fourth, higher dose cohort of 90 mg/m2 as of February 2025.

The company is expanding its value proposition beyond oncology into metabolic disease. BP1001-A is being developed as a potential treatment for obesity in Type 2 diabetes patients. Preclinical studies showed it attenuated fatty acid-induced insulin resistance and restored insulin sensitivity in muscle progenitor and skeletal muscle fiber cell models. The mechanism involves downregulating growth factor receptor-bound protein 2 (Grb2) expression to increase insulin sensitivity and help lower blood glucose levels. Bio-Path Holdings anticipated filing an Investigational New Drug (IND) application in 2025 to initiate a first-in-human Phase 1 clinical trial for this indication. This move targets a substantial market opportunity, as the global market for obesity drugs is valued at over $100 billion.

Here's a quick look at how the pipeline candidates deliver on these propositions:

Drug Candidate	Primary Indication/Target	Value Proposition Focus	Latest Reported Status/Dose
Prexigebersen (BP1001)	AML	Triple combination therapy for newly diagnosed/less refractory patients	Phase 2 trial, utilizing a molecular biomarker package
BP1002	Refractory/Relapsed AML (BCL-2 target)	Treatment for venetoclax-resistant patients	Phase 1/1b trial progressed to the fourth dose cohort of 90 mg/m2
BP1001-A (Modified Prexigebersen)	Advanced Solid Tumors	Targeting difficult-to-treat cancers	Ongoing Phase 1/1b trial
BP1001-A	Obesity in Type 2 Diabetes	Enhancing insulin sensitivity by downregulating Grb2	Completed key preclinical milestones; IND filing anticipated in 2025

The financial context underpinning these value propositions shows the investment required to reach these milestones. For the year ended December 31, 2024, Bio-Path Holdings reported a net loss of $9.9 million. Net cash used in operating activities for that same year was $10.6 million, with cash on hand at the end of 2024 reported at $1.2 million. Still, analyst sentiment in early 2025 reflected belief in the pipeline's potential, with one price target set at $12.00, despite the company having a weak Financial Health Score of 1.43.

The core value propositions can be summarized by the therapeutic focus areas:

• Novel, non-toxic systemic delivery of nucleic acid drugs for cancer.
• Triple combination therapy for AML patients with limited options.
• Potential treatment for obesity/Type 2 Diabetes by enhancing insulin sensitivity.
• Targeting difficult-to-treat cancers like relapsed/refractory AML and solid tumors.

The company's business model centers on generating these drug candidates from the DNAbilize® platform and licensing them for final development and commercialization with partners.

Bio-Path Holdings, Inc. (BPTH) - Canvas Business Model: Customer Relationships

You're looking at how Bio-Path Holdings, Inc. manages its key external relationships, which are critical for advancing its pipeline of DNAbilize®-based drug candidates. Honestly, in biotech, these relationships-from the doctors running the trials to the analysts watching the stock-are your lifeblood.

Direct engagement with clinical investigators and trial sites

The core of Bio-Path Holdings, Inc.'s operational engagement is centered on its active clinical programs across the United States, collaborating with major cancer centers. You need to track the progress across the different studies, as each site represents a direct customer relationship for data collection and patient management. The company's development program as of late 2025 includes:

• One Phase 2 clinical trial for prexigebersen in Acute Myeloid Leukemia (AML).
• Two Phase 1 or 1/1b clinical trials for BP1001-A (solid tumors) and BP1002 (resistant AML).
• Two preclinical programs, including BP1001-A for obesity in Type 2 Diabetes patients.

Key milestones expected to be driven by these investigator relationships in 2025 included the completion of Cohort 2 and an interim analysis for Cohort 3 in the Phase 2 AML trial. The Phase 1/1b trial for BP1001-A is actively enrolling patients with advanced or recurrent solid tumors, specifically mentioning ovarian, uterine, pancreatic, and breast cancer types.

Here's a quick look at the structure of the ongoing clinical engagement:

Drug Candidate	Indication	Trial Phase	Key 2025 Milestone/Status
Prexigebersen (BP1001)	AML	Phase 2	Completion of Cohort 2; Interim analysis for Cohort 3
BP1001-A	Advanced Solid Tumors	Phase 1/1b	Ongoing patient enrollment and treatment
BP1001-A	Obesity/Type 2 Diabetes	Preclinical	IND application planned for submission to the FDA later in 2025
BP1002	Resistant AML	Phase 1/1b	Ongoing evaluation

Investor relations and public updates via press releases and conferences

Managing the relationship with the investment community is vital, especially given the company's market capitalization as of the Q3 reporting period context, which stood at approximately $802,205.60. Public updates serve as the primary touchpoint for current and prospective shareholders. You'll note that Bio-Path Holdings, Inc. hosted a corporate update conference call on May 29, 2025, and CEO Peter Nielsen presented at the Life Sciences Virtual Investor Forum on June 12, 2025. Still, the relationship faced some turbulence, as evidenced by the Form 12b-25 filed on November 17, 2025, delaying the Q3 2025 Form 10-Q due to a change in management. Analysts were expecting Q3 2025 earnings of ($0.40) per share.

Key investor touchpoints in 2025 included:

• Corporate Update Conference Call on May 29, 2025.
• Presentation at Life Sciences Virtual Investor Forum on June 12, 2025.
• Stonegate Capital Partners update on coverage for Q1 2025 on June 4, 2025.

Regulatory communication with the FDA for IND and clinical trial progression

Communication with the U.S. Food and Drug Administration (FDA) is a non-negotiable relationship for a clinical-stage company. Bio-Path Holdings, Inc. has several key regulatory goals set for 2025. The company has been working to advance its candidates, with the Phase 2 AML trial cohorts each being separately approvable by the FDA as a new indication. The planned regulatory interactions for 2025 included:

• Filing an Investigational New Drug (IND) application for BP1001-A in obesity treatment later in 2025.
• Filing an IND application for BP1003, the STAT3 inhibitor.

The company's use of a molecular biomarker package in the Phase 2 AML trial is also a direct communication strategy, designed to improve the probability of success and, by extension, the likelihood of positive regulatory feedback.

Scientific collaboration with key opinion leaders (KOLs)

Leveraging external scientific expertise is a key component of de-risking clinical development, especially in complex areas like hematology. Bio-Path Holdings, Inc. explicitly plans to use external experts to guide its path toward potential FDA approval. This collaboration is focused on their lead oncology program, prexigebersen. The company expects to utilize an advisory panel comprised of AML experts to assist in the design of the final clinical development plans through potential FDA approval. This defintely shows a reliance on KOL input for strategic trial design.

Bio-Path Holdings, Inc. (BPTH) - Canvas Business Model: Channels

You're looking at how Bio-Path Holdings, Inc. gets its science and its stock story out to the world, which is crucial for a clinical-stage biotech with no revenue. The channels are all about proving the science works and securing the capital to keep the lights on until a partnership materializes. Honestly, for a company with only 10 full-time employees, these channels have to be efficient.

Clinical trial sites (Hospitals, Cancer Centers) for drug delivery

The physical channel for drug delivery is the network of sites running the ongoing clinical studies. These sites are the gatekeepers for getting the DNAbilize® platform into patients. The company is leveraging its intellectual property licensed from MD Anderson Cancer Center as a foundational resource for this work.

Here's a quick look at the active clinical channels as of 2025:

Program/Trial Type	Indication Focus	Status/Key Activity in 2025	Dose/Cohort Detail
Prexigebersen Phase 2 Trial	Acute Myeloid Leukemia (AML)	Utilizing molecular biomarker package; expected to complete Cohort 2 and interim analysis for Cohort 3 in 2025.	Three cohorts total; first two use triple combination therapy.
BP1001-A Phase 1/1b Trial	Advanced/Recurrent Solid Tumors	Ongoing; IND application planned for obesity/Type 2 Diabetes later in 2025.	Includes ovarian, uterine, pancreatic, and breast cancer patients.
BP1002 Phase 1/1b Trial	Refractory/Relapsed AML	Progressed to the fourth, higher dose cohort.	Fourth cohort dose is 90 mg/m².

The overall clinical program in early 2025 consisted of one Phase 2 clinical trial, two Phase 1 or 1/1b clinical trials, and two preclinical programs. If onboarding takes too long, trial delays raise capital risk.

Investor presentations and corporate website for capital markets

For capital markets, the corporate website and investor presentations are the primary conduits for communicating progress to secure equity financing. The company sustains its research through this channel. You saw them host a live conference call on May 29, 2025, at 8:30 a.m. ET to provide a business overview, and they presented at the Life Sciences Virtual Investor Forum on June 9, 2025. The financial picture as of the end of 2024 showed cash of $1.2 million, with net cash provided by financing activities being $10.7 million for that year, against net cash used in operating activities of $10.6 million. The latest reported Market Cap, as of a late 2025 context, was around $809.9K, with an analyst price target of $2.00. Still, the EBITDA in the last twelve months was -$12.35 million.

Key investor relations touchpoints include:

• Corporate website for archived webcasts.
• SEC Filings section for official disclosures.
• Presentations section for event materials.
• Form 12b-25 filed for the Q3 2025 Form 10-Q (period ended September 30, 2025).

Scientific publications and conferences for data dissemination

Disseminating positive data is non-negotiable for a pre-revenue company; it validates the science for future partners. The company builds its body of scientific evidence through formal presentations and publications. They reported full-year 2024 financial results on March 28, 2025, and announced a preclinical milestone on May 1, 2025. The DNAbilize® platform is designed to deliver non-toxic, systemically administered nucleic acid drugs.

Data dissemination activities include:

• Presenting efficacy data from the AML trial cohorts.
• Sharing preclinical results for BP1001-A in obesity/Type 2 Diabetes.
• Presenting at investor forums to discuss pipeline advancements.

Future pharmaceutical partners for commercial distribution

The ultimate goal for commercial distribution is licensing out the drug candidates. Bio-Path Holdings' business model explicitly states they develop multiple drug products from the platform technology and license them to partners for final development and commercialization. They aim to partner with experts to finalize development and commercialization of their drug candidates. This channel is the exit strategy for the clinical channel investment.

Bio-Path Holdings, Inc. (BPTH) - Canvas Business Model: Customer Segments

You're looking at the core groups Bio-Path Holdings, Inc. (BPTH) targets with its DNAbilize® platform, spanning from late-stage oncology patients to future metabolic disease sufferers and the capital providers keeping the lights on.

Oncologists and hematologists treating acute myeloid leukemia (AML)

The primary clinical focus involves specialists managing AML, where prexigebersen is being tested in a Phase 2 clinical trial. This trial has three cohorts, with the first two treating patients with a triple combination therapy, and the third cohort specifically targeting relapsed/refractory AML patients who are resistant or intolerant to venetoclax. Bio-Path Holdings expects to utilize a molecular biomarker package in this Phase 2 AML clinical trial throughout 2025 to better identify patients with a higher propensity to respond to prexigebersen treatment. Furthermore, BP1002, which targets the Bcl-2 protein, is also being evaluated for AML treatment.

• Phase 2 AML trial includes cohorts for untreated and relapsed/refractory patients.
• An advisory panel of AML experts is expected to assist in final clinical development plans through potential FDA approval in 2025.
• One AML patient demonstrated treatment durability, receiving 16 cycles of treatment over 21 months as of January 2025.

Patients with relapsed/refractory AML and advanced solid tumors

This segment represents the heavily pretreated patient populations where current standard-of-care options are limited. For advanced solid tumors, BP1001-A is in an ongoing Phase 1/1b clinical trial, which includes patients with recurrent ovarian, endometrial, pancreatic, and breast cancer. The trial progressed to a higher dose cohort of 90 mg/m2 after the initial 60 mg/m2 cohort closed. The clinical response data is compelling; for instance, a patient with gynecologic cancer treated with BP1001-A showed tumor reduction and stable disease continuing through a tenth treatment cycle. This is particularly notable given the patient population is heavily pretreated.

Here's a snapshot of the clinical activity defining this segment's engagement:

Drug Candidate	Indication Focus	Trial Phase/Status (as of mid-2025)	Key Observation/Dose
Prexigebersen	AML (Relapsed/Refractory)	Phase 2 (Third Cohort)	Interim analysis expected in 2025.
BP1001-A	Advanced Solid Tumors	Phase 1/1b	Patient showed tumor reduction on 90 mg/m2 dose.
BP1002	Refractory/Relapsed AML	Phase 1/1b	Reported meaningful patient response to treatment.

Future segment: Endocrinologists and patients with obesity/Type 2 Diabetes

Bio-Path Holdings is actively positioning its platform for a new market by developing BP1001-A as a potential treatment for obesity in Type 2 Diabetes patients. This is supported by preclinical data showing the drug downregulates Grb2 expression, which helps lower blood glucose levels by affecting insulin signaling. The company expects to complete preclinical testing and file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) later in 2025. The preclinical work in March 2025 confirmed BP1001-A attenuated fatty acid-induced insulin resistance and restored insulin sensitivity in skeletal muscle fiber cell models. This signals a clear path toward engaging endocrinology specialists.

• IND application for BP1001-A in obesity/T2D planned for filing in 2025.
• Preclinical studies showed BP1001-A rescues AKT activity in liver cells.
• Preclinical results showed restored insulin sensitivity in muscle cell models (March 2025).

Institutional and retail investors funding the clinical development

The entire development pipeline is sustained by capital from investors, who are keenly watching clinical milestones for potential re-rating events. As of the second quarter of 2025, the company reported Total Assets of $746 Thousand USD against Total Debt of $479 Thousand USD for the trailing twelve months ending June 30, 2025. The operating performance reflects the pre-revenue stage, with EBITDA for the TTM at ($12,132) Thousand USD and Net Income at ($12,317) Thousand USD for the same period. The latest reported EPS for the 12 months was -$2.33. The market capitalization as of June 13, 2025, was $1.16M, based on 8.31M shares outstanding, with a share price noted at $0.21 as of February 18, 2025. Institutional interest is present, with reports indicating 28 institutional owners held 332,436 shares as of February 18, 2025.

Here's the financial context for the capital providers:

Financial Metric (TTM as of 30-Jun-2025)	Amount (In Thousands, USD)	Shareholder Context (As of Feb 2025)	Value
Market Capitalization	1,160 (based on $1.16M)	Institutional Owners (13F/G filers)	28
Total Assets	746	Shares Held by Institutions	332,436
Total Debt	479	Share Price (Feb 18, 2025)	$0.21
Net Income	(12,317)	Key Holder (Armistice Capital, Aug 2024)	97,000 Shares

Retail investors are definitely watching the progress in the Phase 2 AML trial and the planned 2025 IND filing for the obesity indication. Finance: draft 13-week cash view by Friday.

Bio-Path Holdings, Inc. (BPTH) - Canvas Business Model: Cost Structure

You're looking at the core expenses driving Bio-Path Holdings, Inc.'s operations as of late 2025. For a clinical-stage biotech, the cost structure is heavily weighted toward advancing the pipeline.

High Research and Development (R&D) expenses, totaling $4,048K in Q2 2025, represent the largest component of the cost base. This spend directly fuels the company's pipeline progression.

The R&D outlay supports several active programs:

• Clinical trial costs for Phase 1/1b studies, including BP1001-A for advanced solid tumors.
• Advancement of the Phase 2 clinical trial for acute myeloid leukemia (AML).
• Development of a molecular biomarker package for the AML trial.
• Preclinical work for BP1001-A in obesity for Type 2 Diabetes patients.

The total operating expense for Q2 2025 was reported at $4.6M, which encompasses R&D and overhead costs.

Expense Category	Q2 2025 Reported Amount (K USD)	Contextual Data Point
Research and Development (R&D)	4,048	Supports one Phase 2 and two Phase 1/1b trials.
General and Administrative (G&A)	514	Represents corporate overhead and support functions.
Total Operating Expenses (Q2 2025)	4,600	Verifiable figure encompassing R&D and G&A components.

General and Administrative (G&A) expenses, approximately $514K in Q2 2025, cover the necessary corporate infrastructure to support clinical operations.

Legal and intellectual property costs are a fixed, ongoing drain, essential for protecting the DNAbilize® platform. Patent maintenance and legal fees for the global IP portfolio are a constant factor. To be fair, the USPTO fee schedule adjustments effective January 19, 2025, mean these costs are rising.

Specific patent-related costs to note include:

• Across-the-board USPTO fee increases of approximately 7.5%.
• Front-end fees (filing, search, examination) subject to a total 10% increase.
• New surcharges for continuing applications, such as $2,700 for filings six or more years after the earliest benefit date.

Manufacturing costs for clinical-grade drug supply are variable, tied directly to the progression of the ongoing clinical trials. These costs fluctuate based on the specific dosing cohorts being manufactured for the AML and solid tumor studies.

Bio-Path Holdings, Inc. (BPTH) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Bio-Path Holdings, Inc. (BPTH) as of late 2025. Since the company is pre-commercial, the financial reality is that the primary lifeblood isn't drug sales yet; it's the capital markets keeping the lights on while the science moves forward. Honestly, for a clinical-stage biotech, this is completely normal.

The core revenue structure is heavily weighted toward financing activities, which is where the immediate cash comes from to fund the R&D pipeline, including BP1001-A for obesity and the AML programs.

Primary Source: Equity Financing and Warrant Exercises

This is the engine room for Bio-Path Holdings, Inc. right now. You see significant, non-recurring cash injections from issuing stock and warrants to institutional investors. For the full year 2024, net cash provided by financing activities hit $10.7 million. This funding is critical for operations, as the company is burning cash on clinical trials.

Here's a look at some recent capital raises that feed this stream:

Financing Event Type	Date Reference	Gross Proceeds Amount
Private Placement (Shares & Warrants)	October 2024	$4.0 million
Promissory Note Issuance	March 2025	$140,000
Private Placement (Shares & Warrants)	June 2024	$4.0 million

Warrant exercises represent a secondary, contingent part of this primary stream; if investors decide to exercise their warrants at the stated price-like the $1.00 exercise price mentioned for some 2024 warrants-that brings in more non-dilutive cash flow, though the immediate capital is from the initial sale of those warrants. It's all about extending the runway.

Minimal or Non-Core Revenue

As a company deep in development, operational revenue is minimal. You noted that the revenue for the second quarter of 2025 was $4,527K. [cite: Provided in prompt] However, looking at the trailing twelve-month revenue as of June 30, 2025, was reported as null, which confirms that the bulk of the reported revenue is likely non-recurring, such as small research grants or minimal collaboration payments, rather than product sales.

Future Potential Revenue Streams

The real upside, the part that changes the valuation model from a pure financing play to a potential commercial success, lies in future licensing and royalties. Bio-Path Holdings, Inc. expects to seek additional capital through licensing arrangements. The DNAbilize® platform's composition patents allow the company to apply its core technology to new protein targets, which is the foundation for future deal-making.

Key potential revenue triggers you should watch for include:

• Filing an Investigational New Drug (IND) application for BP1001-A in obesity-related Type 2 Diabetes treatment, planned for later in 2025.
• Achieving positive data readouts from ongoing Phase 2 AML trials, which could trigger milestone payments from potential partners.
• Securing a strategic partnership for the obesity program, which is a market valued over $100 billion.

If a partner takes a drug candidate through pivotal trials and commercialization, Bio-Path Holdings, Inc. would then recognize royalties from net sales. Furthermore, the company notes that existing agreements may include payment obligations such as milestone payments or a percentage of any future sublicensing revenues received. That's the long-term goal, but for now, the equity raises are the only hard numbers you can count on.