|
Bio-Path Holdings, Inc. (BPTH): Business Model Canvas [Dec-2025 Updated] |
Fully Editable: Tailor To Your Needs In Excel Or Sheets
Professional Design: Trusted, Industry-Standard Templates
Investor-Approved Valuation Models
MAC/PC Compatible, Fully Unlocked
No Expertise Is Needed; Easy To Follow
Bio-Path Holdings, Inc. (BPTH) Bundle
You're looking to map the actual mechanics of Bio-Path Holdings, Inc. (BPTH) business, and for a clinical-stage firm like this, the model is less about current revenue and more about intellectual property (IP) and managing the cash burn to hit milestones. Honestly, the core value proposition rests squarely on their proprietary DNAbilize® platform, which is protected by a substantial portfolio of 7 US and 61 foreign patents as of early 2025. The real story is in the costs: Q2 2025 saw R&D expenses reach $4,048K, dwarfing the $4,527K in total revenue for that quarter, which tells you this whole operation is currently an equity-funded race to prove out BP1001 in AML. If you want the precise breakdown of their key activities, cost structure, and the crucial partnerships they need to secure future licensing deals, check out the full canvas below.
Bio-Path Holdings, Inc. (BPTH) - Canvas Business Model: Key Partnerships
You're looking at the core external relationships that keep Bio-Path Holdings, Inc. moving forward, especially given the company's current financial footing. Honestly, for a clinical-stage biotech with only 10 fulltime employees and cash on hand at 3/31/25 reported at just $0.1 million, these partnerships are everything. They provide the expertise, the foundational science, and the necessary infrastructure to advance the pipeline, which is critical when your last twelve months EBITDA was -$12.35 million.
MD Anderson Cancer Center for IP Licensing and Research Collaboration
The bedrock of Bio-Path Holdings, Inc.'s technology is its intellectual property, which was originally licensed from The MD Anderson Cancer Center. This relationship is foundational, as it secured the proprietary DNAbilize® liposomal delivery and antisense technology platform. Bio-Path Holdings, Inc. maintains what they describe as a strong relationship with the Cancer Center. This licensing arrangement is key to their ability to create drug candidates like prexigebersen (BP1001) and BP1002, which target proteins implicated in cancer cell growth.
Clinical Research Organizations (CROs) for Managing Phase 1/2 Trials
Managing complex clinical trials requires specialized external support, which is where CROs come into play for Bio-Path Holdings, Inc. While specific CRO names aren't public, these organizations are essential for executing the ongoing studies. For instance, the Phase 2 clinical trial for prexigebersen in Acute Myeloid Leukemia (AML) is comprised of three cohorts, with Bio-Path Holdings, Inc. expecting to complete Cohort 2 and conduct an interim analysis for Cohort 3 in 2025. Separately, the Phase 1/1b clinical trial of BP1001-A in advanced solid tumors is also underway, requiring external management for patient recruitment and data collection across multiple sites.
Here's a quick look at the pipeline activity that these external partners are helping to manage:
- Phase 2 AML trial for prexigebersen is treating patients with triple combination therapy.
- Phase 1/1b trial for BP1001-A is ongoing in advanced or recurrent solid tumors.
- Preclinical testing for BP1001-A in obesity/Type 2 diabetes is expected to conclude in 2025, leading to an IND filing.
Advisory Panel of AML Experts for Clinical Development Plan Design
Expert guidance is non-negotiable when navigating regulatory pathways, especially for a lead candidate like prexigebersen targeting AML. Bio-Path Holdings, Inc. explicitly plans to use an advisory panel of AML experts. The goal here is precise: to assist in the design of the final clinical development plans leading up to potential FDA approval. This external expertise helps de-risk the path forward, which is important when the company's Financial Health Score is rated as weak at 1.43.
Potential Future Co-Development Partners for Commercialization
The DNAbilize® platform is designed to create assets that can be licensed out. Bio-Path Holdings, Inc. sustains its research and clinical programs through equity financing, but the long-term monetization strategy relies on establishing strategic partnerships for later-stage development and commercialization. The company seeks to establish these partnerships as its technology advances through clinical development, which could bring in non-dilutive capital or milestone payments. The expectation from some analysts is that planned 2025 pipeline catalysts could unlock these strategic partnerships and lead to a re-rating of the stock, which currently has an analyst price target of $12.
You can see the focus of these external relationships below:
| Partner Type | Primary Focus Area | Status/Goal |
| MD Anderson Cancer Center | Intellectual Property Licensing | Original technology source; strong ongoing relationship. |
| Clinical Research Organizations (CROs) | Clinical Trial Execution | Managing ongoing Phase 2 (AML) and Phase 1/1b (Solid Tumors) trials. |
| AML Expert Advisory Panel | Regulatory Strategy | Assisting in design of final clinical development plans for FDA submission. |
| Future Co-Development Partners | Commercialization & Licensing | Seeking partners to advance drug candidates through late-stage development and market launch. |
Bio-Path Holdings, Inc. (BPTH) - Canvas Business Model: Key Activities
Conducting Phase 2 clinical trials for prexigebersen (BP1001) in AML remains a central activity. Bio-Path Holdings, Inc. is running this Phase 2 trial using a molecular biomarker package designed to pinpoint patients more likely to respond to the drug targeting the Grb2 protein. The trial structure involves three cohorts, each potentially leading to a separate FDA approval. Cohorts one and two involve a triple combination therapy using prexigebersen, decitabine, and venetoclax. Cohort three specifically addresses relapsed/refractory AML patients who are venetoclax-resistant or intolerant, using a two-drug combination of prexigebersen and decitabine. As of January 2025, the expectation was to complete Cohort 2 and conduct an interim analysis for Cohort 3 within 2025. To be fair, patient durability data shows promise, with two patients reported as continuing treatment well as of January 2025, one having received 20 cycles of treatment.
Advancing preclinical studies for BP1001-A in obesity/Type 2 Diabetes is a key pipeline expansion effort. This drug modification is in preclinical development, with scientific evidence suggesting it enhances insulin sensitivity by downregulating Grb2 protein expression. Key findings from cell models showed BP1001-A reduced Grb2 protein expression in myoblast cells and increased phosphorylated AKT and FOXO-1 levels in myoblast and hepatoma cells when insulin was present. Bio-Path Holdings, Inc. reported achieving a third preclinical milestone in May 2025 supporting this potential. The company planned to use a mouse model in the first half of 2025 to assess the impact on animal weight and its effect on insulin sensitivity and glucose tolerance.
Filing Investigational New Drug (IND) applications for new candidates like BP1003 is a necessary step for pipeline progression. Bio-Path Holdings, Inc. has an IND application expected for BP1003, which is a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide developed as a specific inhibitor of STAT3. Furthermore, the company anticipated filing an IND application for BP1001-A in obesity treatment later in 2025, following the completion of final preclinical testing.
Protecting and expanding the DNAbilize® proprietary patent portfolio is crucial for safeguarding the technology platform and future licensing value. This involves continuous filing and securing of patents covering the core technology and new product candidates. The company's intellectual property is a significant asset, underpinning its entire pipeline of RNAi nanoparticle drugs.
Raising capital through equity financing to fund R&D operations is an ongoing, critical activity, especially given the cash burn associated with clinical development. As of November 14, 2025, Bio-Path Holdings, Inc. was actively seeking financing to support a planned turnaround, acknowledging uncertainty that impacts operations and public listing if capital is not secured. Earlier in the year, on March 5, 2025, the company secured $140,000 in gross proceeds from the sale of a promissory note, which included a $21,000 original issue discount.
Here's a quick look at some of the numbers tied to these key activities as of late 2025:
| Key Activity Metric | Value/Amount | Date/Status Context |
| U.S. Issued Patents (DNAbilize®) | 7 | Issued patents covering the platform technology |
| Foreign Issued Patents | 61 | Issued across 26 countries |
| U.S. Pending Patent Applications | 3 | Additional applications pending |
| AML Trial Cohorts | 3 | Each potentially separately approvable by the FDA |
| BP1001-A Preclinical Milestones Achieved | 3 | Milestones supporting obesity/T2D potential, reported May 2025 |
| Gross Proceeds from March 2025 Financing | $140,000 | Gross proceeds from a promissory note sale |
| Negative EBITDA (Last Twelve Months) | -$12.35 million | Financial metric indicating cash burn |
| Market Capitalization | $4.66M | As of July 2025 |
The company's business model centers on generating new drug candidates from the DNAbilize® platform and licensing them for final development and commercialization with partners that have the necessary expertise and scale to bring them to market.
Bio-Path Holdings, Inc. (BPTH) - Canvas Business Model: Key Resources
You're looking at the core assets Bio-Path Holdings, Inc. relies on to execute its strategy, which centers on developing nucleic acid drugs for cancer and obesity using its proprietary delivery system.
The most fundamental resource is the proprietary DNAbilize® liposomal delivery technology platform, which enables the simple intravenous infusion of RNAi nanoparticle drugs. This platform is the engine for the entire pipeline. It's important to know that composition of matter patents allow the Company to apply this core technology to new protein targets and receive new 20-year patents.
Intellectual property protection is extensive, safeguarding the platform and specific product candidates. As of early 2025, the portfolio included:
- 7 issued patents in the U.S.
- 61 issued patents in foreign jurisdictions across 26 countries
- 3 additional pending patent applications in the U.S.
- 5 additional allowed applications in foreign jurisdictions
The clinical-stage drug pipeline represents the near-term value drivers, spanning oncology and a new push into metabolic disease. Here's a breakdown of the key assets as of mid-2025 updates:
| Product Candidate | Target Protein | Indication/Status | Trial Phase/Key Activity (as of mid-2025) |
| Prexigebersen (BP1001) | Grb2 | Blood Cancers (AML) | Phase 2 clinical trial, comprised of three cohorts |
| BP1001-A | Grb2 (Modification) | Advanced Solid Tumors | Phase 1/1b clinical trial ongoing in ovarian, uterine, pancreatic, and breast cancer |
| BP1001-A | N/A | Obesity/Type 2 Diabetes | Preclinical testing expected to complete in 2025, with an Investigational New Drug (IND) application filing anticipated later in 2025 |
| BP1002 | Bcl-2 | Refractory/Relapsed AML | Phase 1/1b trial in progress, though separate Phase 1 trials were discontinued due to patient enrollment challenges |
| BP1003 | STAT3 | N/A | IND application expected to be filed |
The overall clinical development program as of early 2025 consisted of one Phase 2 clinical trial, two Phase 1 or 1/1b clinical trials, and two preclinical programs. Still, the company reported an EBITDA of -$12.35 million in the last twelve months, and its Financial Health Score was noted at 1.43. Cash on hand was $1.2 million as of December 31, 2024.
Finally, the team's scientific and clinical expertise in antisense RNAi therapeutics is a critical intangible asset, underpinning the development of these novel drugs. This expertise is being applied to generate data, such as the net loss for the year ended December 31, 2024, being $9.9 million, an improvement from the $16.1 million loss for the comparable period in 2023. Finance: draft Q3 2025 cash burn projection by next Tuesday.
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.
Disclaimer
All information, articles, and product details provided on this website are for general informational and educational purposes only. We do not claim any ownership over, nor do we intend to infringe upon, any trademarks, copyrights, logos, brand names, or other intellectual property mentioned or depicted on this site. Such intellectual property remains the property of its respective owners, and any references here are made solely for identification or informational purposes, without implying any affiliation, endorsement, or partnership.
We make no representations or warranties, express or implied, regarding the accuracy, completeness, or suitability of any content or products presented. Nothing on this website should be construed as legal, tax, investment, financial, medical, or other professional advice. In addition, no part of this site—including articles or product references—constitutes a solicitation, recommendation, endorsement, advertisement, or offer to buy or sell any securities, franchises, or other financial instruments, particularly in jurisdictions where such activity would be unlawful.
All content is of a general nature and may not address the specific circumstances of any individual or entity. It is not a substitute for professional advice or services. Any actions you take based on the information provided here are strictly at your own risk. You accept full responsibility for any decisions or outcomes arising from your use of this website and agree to release us from any liability in connection with your use of, or reliance upon, the content or products found herein.