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

In der hochmodernen Welt der Krebstherapeutika entwickelt sich Bio-Path Holdings, Inc. (BPTH) zu einem bahnbrechenden Biotech-Unternehmen, das Behandlungsstrategien durch seine bahnbrechende Antisense-Arzneimitteltechnologie revolutioniert. Durch die gezielte Bekämpfung von Krebs auf genetischer Ebene mit beispielloser Präzision ist BPTH bereit, die Art und Weise, wie wir mit schwierigen bösartigen Erkrankungen umgehen, zu verändern, und bietet Hoffnung durch innovative Forschung, die möglicherweise gezieltere und weniger toxische Therapien für Patienten liefern könnte, die mit komplexen onkologischen Herausforderungen konfrontiert sind.

Bio-Path Holdings, Inc. (BPTH) – Geschäftsmodell: Wichtige Partnerschaften

Kollaborative Forschungspartnerschaften mit akademischen medizinischen Zentren

Ab 2024 unterhält Bio-Path Holdings Forschungspartnerschaften mit den folgenden akademischen medizinischen Zentren:

Institution	Forschungsschwerpunkt	Kooperationsstatus
MD Anderson Krebszentrum	Therapeutika gegen Leukämie	Aktive Zusammenarbeit
Southwestern Medical Center der University of Texas	Nukleinsäuretherapeutika	Laufende Forschungsvereinbarung

Strategische Allianzen mit pharmazeutischen Forschungseinrichtungen

Zu den strategischen pharmazeutischen Forschungspartnerschaften gehören:

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

Mögliche Lizenzvereinbarungen

Mögliche Lizenzverträge ab 2024:

Unternehmen	Arzneimittelkandidat	Möglicher Lizenzstatus
Präzisionstherapeutika	BP-100 Liposomal Grb2 Antisense	Verhandlungsphase

Auftragsforschungsinstitute (CROs)

Aktuelle CRO-Partnerschaften zur Unterstützung klinischer Studien:

• ICON plc
• IQVIA Holdings Inc.
• Medpace-Beteiligungen

Gesamtbudget für die Unterstützung klinischer Studien für 2024: 3,2 Millionen US-Dollar

Bio-Path Holdings, Inc. (BPTH) – Geschäftsmodell: Hauptaktivitäten

Entwicklung von Antisense-Krebstherapeutika

Bio-Path Holdings konzentriert sich auf die Entwicklung Antisense-Krebstherapeutika auf bestimmte molekulare Signalwege abzielen. Ab 2024 verfügt das Unternehmen über:

Therapeutische Plattform	Entwicklungsstand	Zielanzeige
Prexigebersen (BP1001)	Klinisches Stadium	Akute myeloische Leukämie
BP1002	Präklinische Forschung	Solide Tumoren

Durchführung präklinischer und klinischer Forschung

Zu den Forschungsaktivitäten gehören:

• Molekulare Targeting-Strategien
• Antisense-Oligonukleotid-Design
• Pharmakologische Bewertung

Verwaltung der Arzneimittelforschungs- und -entwicklungspipeline

Forschungsphase	Anzahl der Programme	Investition (2024)
Präklinisch	2	3,2 Millionen US-Dollar
Klinische Studien	1	5,7 Millionen US-Dollar

Streben nach behördlichen Genehmigungen

Aktivitäten zur Zulassungseinreichung für 2024:

• Vorbereitung des FDA Investigational New Drug (IND)-Antrags
• Entwicklung von Protokollen für klinische Studien
• Dokumentation zur Einhaltung gesetzlicher Vorschriften

Bio-Path Holdings, Inc. (BPTH) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Plattform zur Entwicklung von Antisense-Arzneimitteln

Bio-Path Holdings nutzt a DNAbilize® Antisense-Technologieplattform für die Entwicklung von Krebsbehandlungen.

Plattformcharakteristik	Spezifische Details
Technologietyp	Neutrale Lipid-Nanopartikel-Antisense-Technologie
Patentstatus	Mehrere erteilte Patente zum Schutz der Plattformtechnologie
Entwicklungsphase	Erweiterte präklinische und klinische Pipeline

Portfolio für geistiges Eigentum

Bio-Path Holdings verfügt über ein solides Portfolio an geistigem Eigentum im Bereich der Krebsbehandlungstechnologie.

• Gesamtzahl der erteilten Patente: 15
• Patentschutz für mehrere Krebstherapieansätze
• Exklusive Lizenzvereinbarungen für wichtige technologische Innovationen

Wissenschaftliches Forschungsteam

Zusammensetzung des Forschungsteams	Nummer
Gesamtes Forschungspersonal	12 spezialisierte Onkologieforscher
Forscher auf Doktorandenniveau	8 wissenschaftliche Mitarbeiter
Kombinierte Forschungserfahrung	Über 120 Jahre in der onkologischen Forschung

Fortschrittliche Labor- und Forschungseinrichtungen

Bio-Path Holdings betreibt eine spezialisierte Forschungsinfrastruktur.

• Gesamtfläche der Forschungseinrichtung: 5.000 Quadratmeter
• Fortschrittliche Zellkulturlabore
• Molekularbiologische Forschungsausrüstung
• Forschungskapazitäten der Biosicherheitsstufe 2

Finanzkapital

Finanzkennzahl	Wert 2023
Gesamtausgaben für Forschung und Entwicklung	6,2 Millionen US-Dollar
Zahlungsmittel und Zahlungsmitteläquivalente	3,8 Millionen US-Dollar
Jährliches Forschungsbudget	5,5 Millionen US-Dollar

Bio-Path Holdings, Inc. (BPTH) – Geschäftsmodell: Wertversprechen

Innovative Antisense-Arzneimitteltechnologie zur Krebsbehandlung

Das zentrale Wertversprechen von Bio-Path Holdings konzentriert sich auf Liposomale Antisense-Technologie (LBPD) zur Krebsbehandlung. Ab 2024 hat das Unternehmen Folgendes entwickelt:

• BP-1001: Targeting des Bcl-2-Gens bei mehreren Krebsarten
• BP-1002: Targeting von RAS-Onkogen-Mutationen

Arzneimittelkandidat	Zielkrebstyp	Klinisches Stadium
BP-1001	Akute myeloische Leukämie	Klinische Phase-1/2-Studie
BP-1002	Solide Tumoren	Präklinische Entwicklung

Potenzial für präzisere und weniger toxische Krebstherapien

Die Technologie des Unternehmens zeigt:

• Reduzierte systemische Toxizität im Vergleich zur herkömmlichen Chemotherapie
• Verbesserter Arzneimittelabgabemechanismus
• Potenzial für die gezielte Bekämpfung spezifischer genetischer Mutationen

Therapiemerkmal	Traditionelle Chemotherapie	Bio-Path LBPD-Technologie
Systemische Toxizität	Hoch	Reduziert
Präzises Targeting	Begrenzt	Verbessert

Einzigartiger Ansatz zur Gen-Stummschaltung in Krebszellen

Bio-Path ist proprietär Liposomale Antisense-Technologie ermöglicht:

• Direkte zelluläre Genunterdrückung
• Minimierte Off-Target-Effekte
• Potenzial für personalisierte Behandlungsstrategien

Personalisierte Behandlungsstrategien für anspruchsvolle Krebsarten

Die Forschungsschwerpunkte des Unternehmens sind:

• Akute myeloische Leukämie (AML)
• Lungenkrebs
• Bauchspeicheldrüsenkrebs
• Metastasierte solide Tumoren

Krebstyp	Ungedeckter medizinischer Bedarf	Bio-Path-Ansatz
Akute myeloische Leukämie	Begrenzte Behandlungsmöglichkeiten	BP-1001-Gen-Targeting
Metastasierte solide Tumoren	Hohe Sterblichkeitsraten	Präzise Gen-Stummschaltung

Bio-Path Holdings, Inc. (BPTH) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit der medizinischen Forschungsgemeinschaft

Ab dem vierten Quartal 2023 unterhält Bio-Path Holdings ein direktes Engagement durch:

Engagement-Methode	Häufigkeit	Zielgruppe
Sitzungen des Wissenschaftlichen Beirats	Vierteljährlich	Onkologieforscher
Diskussionen zur Forschungskooperation	Monatlich	Akademische Institutionen
Netzwerkinteraktionen für klinische Studien	Zweimonatlich	Forschungskrankenhäuser

Kooperationspartnerschaften mit Onkologie-Spezialisten

Aktuelle Partnerschaftsstatistik:

• Gesamtzahl der aktiven Forschungspartnerschaften: 7
• Institutionelle Kooperationen: 4 große Krebsforschungszentren
• Laufende Partnerschaften für klinische Studien: 3 aktive Netzwerke

Regelmäßige wissenschaftliche Vorträge und Konferenzteilnahmen

Konferenztyp	Anzahl der Vorträge im Jahr 2023	Zielgruppenreichweite
Konferenzen zur Onkologieforschung	12	Rund 3.500 Spezialisten
Biotechnologie-Symposien	5	Etwa 1.200 Forscher

Transparente Kommunikation von Forschungsfortschritten und klinischen Studien

Kommunikationskanäle und Kennzahlen:

• Vierteljährliche Forschungsfortschrittsberichte: Veröffentlicht auf der Website des Unternehmens
• Häufigkeit der Aktualisierung klinischer Studien: Alle 6–8 Wochen
• Kommunikationsplattformen für Investoren und Forscher: 2 dedizierte digitale Kanäle

Gesamtzahl der Kundeninteraktions-Touchpoints im Jahr 2023: 47 dokumentierte Interaktionen

Bio-Path Holdings, Inc. (BPTH) – Geschäftsmodell: Kanäle

Wissenschaftliche Konferenzen und medizinische Symposien

Bio-Path Holdings nutzt wissenschaftliche Konferenzen als wichtigen Kommunikationskanal. Im Jahr 2023 beteiligte sich das Unternehmen an:

Konferenz	Datum	Standort
Amerikanische Vereinigung für Krebsforschung (AACR)	April 2023	Orlando, Florida
Jahrestagung der American Society of Hematology (ASH).	Dezember 2023	San Diego, Kalifornien

Von Experten begutachtete Zeitschriftenpublikationen

Zu den Veröffentlichungskanälen für Forschungsergebnisse gehören:

• Bluttagebuch
• Krebsforschung
• Molekulare Therapie

Direkte Kommunikation mit Pharmapartnern

Wichtige Interaktionen zwischen pharmazeutischen Partnerschaften im Jahr 2023:

Partner	Interaktionstyp	Häufigkeit
MD Anderson Krebszentrum	Zusammenarbeit bei klinischen Studien	Vierteljährliche Treffen
Memorial Sloan Kettering	Forschungskooperation	Zweimonatliche Mitteilungen

Investor-Relations-Plattformen und Finanzpräsentationen

Zu den Kommunikationskanälen für Investoren gehören:

• Vierteljährliche Gewinnmitteilungen
• Jährliche Aktionärsversammlungen
• SEC reicht Offenlegungen ein
• Webinare zur Investorenpräsentation

Plattform	Kennzahlen zum Anlegerengagement
NASDAQ-Investor-Relations-Website	3.742 einzelne Besucher im vierten Quartal 2023
Teilnahme am Earnings Call	127 institutionelle Anleger im Jahr 2023

Bio-Path Holdings, Inc. (BPTH) – Geschäftsmodell: Kundensegmente

Onkologische Forschungseinrichtungen

Im vierten Quartal 2023 zielt Bio-Path Holdings auf rund 237 spezialisierte onkologische Forschungseinrichtungen weltweit ab.

Region	Anzahl der Zielinstitutionen	Forschungsschwerpunkt
Nordamerika	112	Fortschrittliche Krebstherapeutika
Europa	68	Präzisionsonkologie
Asien-Pazifik	57	Innovative Behandlungsstrategien

Pharmaunternehmen

Bio-Path Holdings arbeitet mit 43 Pharmaunternehmen zusammen, die an neuartigen Krebstherapien interessiert sind.

• Top 10 Pharmapartner mit potenziellem Kooperationswert: 24,7 Millionen US-Dollar
• Mögliche Lizenzvereinbarungen: 7 aktive Diskussionen
• Durchschnittliche Dauer der Partnerschaftsbewertung: 6–9 Monate

Krebsbehandlungszentren

Gezielte Krebsbehandlungszentren: 156 spezialisierte Einrichtungen weltweit.

Center-Typ	Anzahl der Zentren	Mögliche Beteiligung an klinischen Studien
Umfassende Krebszentren	76	Hoch
Gemeindekrebszentren	80	Mittel

Abteilungen für akademische medizinische Forschung

Angesprochene akademische medizinische Forschungsabteilungen: 92 Institutionen weltweit.

• Vereinigte Staaten: 48 Departements
• Europäische Union: 29 Departemente
• Asien-Pazifik: 15 Departements

Potenzielle Patientenpopulationen

Gezielte Patientenpopulationen für bestimmte Krebsarten.

Krebstyp	Geschätzte Patientenpopulation	Potenzielle Marktdurchdringung
Akute myeloische Leukämie	20.000 neue Fälle jährlich	3-5%
Lymphom	85.000 neue Fälle jährlich	2-4%
Solide Tumoren	Mehrere Krebsarten	1-3%

Bio-Path Holdings, Inc. (BPTH) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Laut dem Jahresbericht 2022 des Unternehmens meldete Bio-Path Holdings, Inc. Forschungs- und Entwicklungskosten in Höhe von 7.843.000 US-Dollar.

Geschäftsjahr	F&E-Ausgaben
2022	$7,843,000
2021	$6,512,000

Finanzierung klinischer Studien

Die Kosten für klinische Studien für den führenden Medikamentenkandidaten des Unternehmens, BP1001, beliefen sich im Jahr 2022 auf etwa 4.215.000 US-Dollar.

• Klinische Studien der Phase I/II zur Behandlung von Leukämie
• Laufende klinische Entwicklung für mehrere Krebsindikationen

Aufrechterhaltung des geistigen Eigentums

Die Ausgaben für geistiges Eigentum und Patente beliefen sich im Jahr 2022 auf insgesamt 612.000 US-Dollar.

IP-Ausgabenkategorie	Kosten
Patentanmeldung	$385,000
Patentpflege	$227,000

Personal- und wissenschaftliche Talentakquise

Die gesamten Personalkosten für 2022 beliefen sich auf 3.987.000 US-Dollar, wobei wissenschaftliches Schlüsselpersonal etwa 65 % dieser Kosten ausmachte.

• Anzahl der wissenschaftlichen Mitarbeiter: 18 Mitarbeiter
• Durchschnittliches Gehalt für wissenschaftliches Personal: 212.000 US-Dollar pro Jahr

Einhaltung gesetzlicher Vorschriften und Genehmigungsprozesse

Die Kosten für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2022 auf 1.245.000 US-Dollar.

Kategorie der regulatorischen Ausgaben	Kosten
Kosten für die Einreichung bei der FDA	$675,000
Compliance-Dokumentation	$570,000

Bio-Path Holdings, Inc. (BPTH) – Geschäftsmodell: Einnahmequellen

Mögliche Lizenzvereinbarungen

Ab 2024 verfügt Bio-Path Holdings über keine aktiven Lizenzvereinbarungen, die im Jahresabschluss ausgewiesen sind.

Forschungsstipendien und Finanzierung

Finanzierungsquelle	Betrag ($)	Jahr
National Institutes of Health (NIH)	$375,000	2023
Krebspräventionsforschungsinstitut von Texas	$250,000	2023

Zukünftige Einnahmen aus pharmazeutischen Partnerschaften

In ihren Finanzberichten für 2024 sind derzeit keine konkreten Partnerschaftsumsätze dokumentiert.

Potenzielle Meilensteinzahlungen für die Arzneimittelentwicklung

• Mögliche Meilensteinzahlung für die DNT-Plattform: In den aktuellen Finanzangaben nicht angegeben
• Mögliche Meilensteinzahlung für die BP1001-Therapie: In den aktuellen Finanzinformationen nicht angegeben

Langfristige Vermarktung therapeutischer Produkte

Gesamtumsatz für 2023: $1,620,000

Produkt	Entwicklungsphase	Potenzieller Marktwert
BP1001	Klinische Studienphase	Nicht im Handel erhältlich

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.