BiomX Inc. (PHGE): Business Model Canvas [Dec-2025 Updated]

You're looking at a biotech with a fascinating, high-potential platform-precision phage therapy-but the clock is definitely ticking on the cash runway. BiomX Inc. is deep in the crucial Phase 2b trial for BX004 in Cystic Fibrosis, a high-unmet need area, and they've secured solid non-dilutive funding from the U.S. Defense Health Agency, totaling approximately $40 million to date. Still, with Q3 2025 revenue barely hitting $0.4 million and only $8.1 million in cash as of September 30, 2025, the next few quarters are all about flawless clinical execution and securing financing to push past Q1 2026. Let's map out the nine blocks of their Business Model Canvas to see exactly where the value is anchored and what near-term risks you need to track.

BiomX Inc. (PHGE) - Canvas Business Model: Key Partnerships

You're looking at the foundation of BiomX Inc. (PHGE)'s near-term value, which is heavily reliant on strategic, non-dilutive funding and collaborations, especially given that as of September 30, 2025, the company's cash and restricted cash balance was only $8.1 million, estimated to fund operations into the first quarter of 2026. Net cash used in operating activities for the first nine months of 2025 was $22.0 million, so these partnerships are defintely critical for bridging the gap to key clinical milestones.

The most significant validation comes from the U.S. defense sector. BiomX Inc. has secured approximately $40 million in non-dilutive funding from the U.S. Defense Health Agency (DHA) to advance its phage therapy development, specifically for the BX211 program targeting diabetic foot osteomyelitis (DFO). This funding, administered through the Naval Medical Research Command, signals a strategic alignment with military needs for solutions against antibiotic-resistant infections.

Here's a quick look at the core strategic alliances driving the platform:

The collaborations with major pharmaceutical players are focused on leveraging BiomX Inc.'s proprietary technology platforms. The discovery collaboration with Janssen Pharmaceuticals, Inc. centers on using the XMarker microbiome-based biomarker discovery platform. This is designed to help stratify patients who will respond versus those who won't respond to treatments for inflammatory bowel disease (IBD). Also, you see two separate collaborations established with Boehringer Ingelheim, indicating a broader interest from that entity in the technology.

Executing the clinical pipeline, particularly the BX004 Phase 2b trial for cystic fibrosis (CF), requires a network of specialized external support. This involves engaging clinical research organizations (CROs) and multiple multicenter trial sites. The BX004 trial itself is a randomized, double-blind, placebo-controlled, multi-center study designed to enroll approximately 60 patients, randomized 2:1 to BX004 or placebo over an 8-week treatment period. Topline results from this trial are now expected in the second quarter of 2026, pending protocol updates following a Data Monitoring Committee review.

The structure of the ongoing Phase 2b trial, which is crucial for the BX004 program, involves specific parameters:

• Trial Design: Randomized, double-blind, placebo-controlled.
• Patient Enrollment Target: Approximately 60 patients.
• Randomization Ratio: 2:1 ratio to BX004 versus placebo.
• Treatment Duration: 8 weeks via inhalation twice daily.
• Expected Readout: Topline data anticipated in Q2 2026.

Finance: draft 13-week cash view by Friday.

BiomX Inc. (PHGE) - Canvas Business Model: Key Activities

You're looking at a company deep in clinical execution, where every activity is geared toward hitting data readouts that will unlock the next stage of financing. Here's the breakdown of what BiomX Inc. is actively driving as of late 2025.

Executing Phase 2b Clinical Trial for BX004 in Cystic Fibrosis (CF)

The primary focus remains on the Phase 2b trial for BX004, the fixed multi-phage cocktail targeting P. aeruginosa in CF patients. Enrollment and dosing in Europe have continued, even while U.S. enrollment is paused due to a clinical hold related to the delivery device. The company is working to resolve this hold to resume U.S. screening and enrollment. An independent Data Monitoring Committee (DMC) reviewed adverse events and recommended the study continue, but with an adjusted dosing regimen. This means the protocol is being updated before the final readout.

Key metrics for this activity include:

• Expected topline results readout: Q2 2026.
• Planned enrollment size for the Phase 2b trial: up to approximately 60 patients.
• Prior positive data from Part 2 showed improvement in pulmonary function in a subgroup with baseline FEV1 less than 70%.
• Recruitment and dosing in Europe have continued ahead of schedule throughout the U.S. clinical hold.

Advancing BX011 Development for Diabetic Foot Infections (DFI) following positive FDA feedback

BiomX Inc. is prioritizing the advancement of BX011, a next-generation fixed multi-phage cocktail targeting Staphylococcus aureus in Diabetic Foot Infections (DFI). This follows the receipt of positive feedback from the FDA on the proposed clinical development pathway, confirming a clear path forward for DFI as the lead indication. This activity builds directly on the success of the prior BX211 program in Diabetic Foot Osteomyelitis (DFO). The plan is to initiate a Phase 2a trial for BX011, contingent on securing the necessary financial resources.

The prior BX211 DFO trial, which reported statistically significant positive topline results in March 2025, provides the foundation for this advancement. The data showed:

The development of BX011 is also aligned with ongoing discussions with the U.S. Defense Health Agency (DHA).

Phage Discovery and Engineering using the proprietary BOLT platform

The core scientific engine for BiomX Inc. is the discovery and engineering of phage compositions. This activity involves validating proprietary bacterial targets and then customizing the phage cocktails against them using their proprietary technology. This platform is what underpins both BX004 and BX011.

• The platform is named BOLT, which stands for BacteriOphage Lead to Treatment.
• The platform was validated by demonstrating a significant reduction in P. aeruginosa bacteria with no emergent resistance in the BX004 Phase 1b/2a trial data published in July 2025.
• The BX211 program, which informed BX011, was supported by approximately $40 million in non-dilutive funding from the U.S. DHA.

Managing Regulatory Submissions and Discussions with the FDA

Regulatory management is a critical, ongoing activity, particularly concerning the clinical hold on the U.S. portion of the BX004 trial. The company is actively working with the third-party nebulizer manufacturer to address the FDA's follow-up information requests to lift this hold. Separately, the company has received new encouraging written feedback from the FDA regarding BX004 that provided guidance on potential Phase 3 development pathways, including strategies to enrich study populations. BiomX Inc. anticipates further discussion with the FDA at an End-of-Phase 2 meeting once the Phase 2b results are reviewed.

Securing Additional Financing to Extend Cash Runway past Q1 2026

Liquidity management is an immediate, high-priority activity. The company's cash position requires action to sustain operations beyond the near term. The financial reality dictates that securing additional capital or a partnership is necessary to fund the planned Phase 2a trial for BX011 and ongoing operations.

Here are the key financial figures framing this activity as of the third quarter of 2025:

Here's the quick math: The cash position has tightened significantly, meaning financing is defintely a near-term focus.

The company completed a financing in February 2025, which, along with warrant exercises approved in April 2025, extended the runway to its current estimate.

Finance: draft 13-week cash view by Friday.

BiomX Inc. (PHGE) - Canvas Business Model: Key Resources

You're looking at the core assets BiomX Inc. (PHGE) is relying on to push its pipeline forward, and honestly, the list is dominated by proprietary science and a very tight cash position. These are the things that, if they work, create all the value.

The most critical tangible resource right now is the capital base. As of September 30, 2025, BiomX Inc. reported a cash balance and restricted cash of $8.1 million. This figure reflects a significant draw-down from the $18 million held at the end of 2024. The net cash used in operating activities for the first nine months of 2025 hit $22.0 million. Management estimates this cash is only sufficient to fund operations into the first quarter of 2026, so financing risk is defintely the near-term constraint on all other resources.

Proprietary Technology and Product Candidates

The foundation of BiomX Inc.'s value proposition is its technology and the specific drug candidates it has generated. The company's ability to execute hinges on these two elements.

The proprietary BOLT (BacteriOphage Lead to Treatment) platform technology is central. This platform is comprised of several integrated components designed to rapidly develop targeted phage compositions:

• Proprietary computational tools.
• Automated screening capabilities.
• Synthetic engineering capabilities.
• Various validation assays.

The platform combines ultra-high-resolution DNA analysis, AI techniques, and high-scale cloud computing resources to build classifiers.

This platform is used to generate the fixed multi-phage cocktail candidates, which represent the near-term value drivers:

Intellectual Property and Human Capital

The specialized teams and the intellectual property (IP) portfolio translate the platform's potential into defensible assets. The investment in the scientific and clinical capabilities is reflected in the operating expenses.

Investment in the specialized scientific and clinical development teams is a significant ongoing cost, with net Research and Development expenses for the third quarter of 2025 reported at $6.1 million. This spending supports the advancement of the pipeline and engagement with regulatory bodies like the FDA.

The intellectual property portfolio is the legal moat around the technology and candidates. While specific patent counts aren't readily available, the IP covers the phage compositions and the proprietary bacterial targets discovered using the BOLT platform. The validation of the platform through positive data publication in Nature Communications further strengthens the underlying IP position.

Here's a look at the financial commitment to these core non-cash resources:

• Q3 2025 R&D Expense: $6.1 million.
• Nine Months Ended Sept 30, 2025 Net Cash Used in Operations: $22.0 million.
• Cash Balance as of September 30, 2025: $8.1 million.

Finance: draft 13-week cash view by Friday.

BiomX Inc. (PHGE) - Canvas Business Model: Value Propositions

You're looking at the core reasons why a patient or payer would choose BiomX Inc. (PHGE) over existing options, and frankly, the data coming out in late 2025 is compelling for this novel approach.

Novel precision phage therapy for chronic, antibiotic-resistant infections.

The fundamental value is the ability to use engineered and natural bacteriophages to selectively target and destroy specific pathogenic bacteria, which is a major departure from broad-spectrum antibiotics. This precision helps preserve the healthy microbiome, a key limitation of traditional treatments.

BX004: Targeting P. aeruginosa in CF patients, a high unmet need.

For Cystic Fibrosis (CF) patients battling chronic P. aeruginosa infections, BX004 offers a targeted alternative. The Phase 1b/2a trial provided strong proof-of-concept data:

• Demonstrated a bacterial reduction of 2.7 log₁₀, which is roughly 500-fold, versus placebo.
• Achieved complete bacterial clearance in 14.3% of patients after just 10 days of treatment.
• The therapy was generally safe, showing no emergence of bacterial resistance to BX004.

BiomX Inc. has advanced this into a randomized, double-blind, placebo-controlled Phase 2b trial, aiming to enroll approximately 60 CF patients with chronic P. aeruginosa lung infections. Topline results from this study are anticipated in the first quarter of 2026 (Q1 2026). The product has already secured FDA Fast Track and Orphan Drug Designations.

The value proposition here is addressing a leading cause of morbidity and mortality in CF patients where modern treatments are falling short.

BX011: Clear regulatory path for S. aureus in Diabetic Foot Infections (DFI).

For Staphylococcus aureus infections in Diabetic Foot Infections (DFI), BiomX Inc. has secured a clear path forward. In November 2025, the company received positive feedback from the FDA on the proposed clinical developmental pathway for BX011, supporting its advancement as the lead indication over Diabetic Foot Osteomyelitis (DFO).

This clarity is built upon prior success with the related product, BX211, in DFO:

The plan is to move into a Phase 2a clinical trial for DFI, with no additional non-clinical studies required, and the FDA provided guidance supporting a path toward a potential Biologics License Application (BLA). This development is supported by approximately $40 million in non-dilutive funding from the U.S. Defense Health Agency (DHA).

Potential for accelerated path based on real-world evidence for bacterial reduction.

BiomX Inc. is actively engaging with the FDA to streamline potential future filings, particularly for BX004. The company received written FDA feedback in October 2025 outlining potential Phase 3 development pathways, recognizing the significant unmet need in CF patients treated with CFTR modulators. Furthermore, BiomX planned discussions in the second half of 2025 to seek endorsement on analyzing real-world evidence to link bacterial reduction directly to clinical outcomes, which could streamline the approval pathway.

The value here is a potential regulatory shortcut, moving beyond traditional endpoints if microbiological success can be clearly tied to patient benefit.

BiomX Inc. (PHGE) - Canvas Business Model: Customer Relationships

You're looking at how BiomX Inc. manages its crucial external relationships as of late 2025, which are heavily weighted toward scientific validation and regulatory navigation. This isn't about mass-market sales yet; it's about high-stakes, direct engagement with gatekeepers.

High-touch, direct engagement with regulatory bodies (FDA, DHA)

Engagement with the U.S. Food and Drug Administration (FDA) and the U.S. Defense Health Agency (DHA) is central to BiomX Inc.'s near-term strategy. The relationship with the FDA is currently focused on resolving a clinical hold and clarifying future trial designs.

• In October 2025, BiomX Inc. received written FDA feedback recognizing the significant unmet need among cystic fibrosis (CF) patients treated with CFTR modulators and outlining potential Phase 3 development pathways for BX004.
• The FDA placed a clinical hold on U.S. trial sites for the BX004 Phase 2b study due to issues with a third-party nebulizer device, not the drug candidate itself.
• Enrollment and dosing for the BX004 Phase 2b trial continued without interruption at European sites.
• For BX011, targeting Staphylococcus aureus in diabetic foot infections, the FDA provided positive, constructive guidance outlining a clear potential pathway toward a Biologics License Application (BLA); no additional nonclinical studies were requested.
• The DHA has supported the BX211 program to date with approximately $40 million in non-dilutive funding.
• BiomX Inc. is in continued discussions with the DHA regarding next steps to support the utilization of phage therapy for S. aureus-driven infections.

Close, collaborative relationships with clinical investigators

The company's relationship with clinical investigators is defined by the execution of its ongoing trials. These investigators are key partners in generating the data needed for regulatory submissions.

• BiomX Inc. successfully initiated patient dosing in its BX004 Phase 2b trial in July 2025, a randomized, double-blind, placebo-controlled, multicenter study involving approximately 60 CF patients with chronic Pseudomonas aeruginosa infections.
• The company is planning a potential registrational study for BX211, pending feedback from the FDA.

Investor relations and transparent communication via quarterly calls

BiomX Inc. maintains a relationship with its investor base through regular, detailed financial reporting, especially critical given the company's cash position and development timeline. The company hosted its Third Quarter 2025 Financial Results Conference Call on November 12, 2025, at 8:30 AM ET.

Here are the key financial metrics shared around this period, which directly inform investor sentiment and the perceived health of the business relationship:

Analyst sentiment, a proxy for professional investor relationship health, showed H.C. Wainwright maintaining a Buy rating with a $26.00 price target, despite the stock trading near its 52-week low of $4.65 in late November 2025. The company also implemented a one-for-nineteen reverse stock split, effective November 25, 2025. That's a big move to manage perception.

BiomX Inc. (PHGE) - Canvas Business Model: Channels

You're looking at how BiomX Inc. (PHGE) gets its science and potential therapies out to the world, which, for a clinical-stage company, is less about shelves and more about sites and papers right now. Their channels are heavily weighted toward validation and clinical execution as of late 2025.

Global clinical trial network for patient enrollment and drug delivery

The primary channel for getting their drug candidates, like BX004, into the hands of patients is the clinical trial network. This is where the rubber meets the road for data generation. You need to track the patient flow here, as it directly impacts the timeline for commercial readiness.

For the BX004 program targeting chronic Pseudomonas aeruginosa in cystic fibrosis (CF) patients, the company successfully initiated patient dosing in the Phase 2b trial in July 2025. This trial is designed to enroll up to approximately 60 patients. It's important to note that while the U.S. sites faced a clinical hold (related to a third-party nebulizer, not the drug itself), enrollment and dosing are continuing outside the U.S. in accordance with the protocol. The expectation for topline results from this Phase 2b study is set for Q1 2026.

Here's a quick look at the validation and execution channels as of the third quarter of 2025:

Scientific publications (Nature Communications) to validate platform technology

Validation from the broader scientific community is a critical channel for de-risking the technology for future partners and investors. BiomX Inc. uses high-impact publications to signal platform robustness.

• Publication of BX004 Phase 1b/2a trial data occurred in Nature Communications in July 2025.
• The published data demonstrated that BX004 achieved approximately a 500 fold bacterial reduction, equivalent to a 2.7 log reduction, compared to placebo in CF patients.
• The same publication highlighted that no bacterial resistance to BX004 emerged during the trial.

Direct licensing and collaboration agreements with pharmaceutical partners

For a company like BiomX Inc., non-dilutive funding and strategic partnerships act as crucial early-stage commercial channels, validating the technology through external investment and shared development costs. This is how they extend their runway, which was $8.1 million in cash as of September 30, 2025, estimated to last into Q1 2026.

The most concrete example of this channel in action is the support for the BX211 program. The BX211 development has been supported by approximately $40 million in non-dilutive funding from the U.S. Defense Health Agency (DHA). Furthermore, in Q2 2025, the company noted increased grant funding from the Medical Technology Enterprise Consortium and the Israel Innovation Authority. These agreements provide capital without immediate equity dilution, which is defintely a positive sign for managing cash burn, which was $22.0 million used in operating activities for the first nine months of 2025.

Future specialized sales force for commercial launch in niche markets

This channel is currently theoretical, as BiomX Inc. is pre-commercial. The focus is on advancing the pipeline, with the FDA providing constructive guidance for a potential Biologics License Application (BLA) pathway for BX011 in diabetic foot infections (DFI). The company plans to prioritize DFI as the lead indication for regulatory development. The actual size, structure, or financial investment related to a future specialized sales force is not yet disclosed, as the current focus remains on clinical milestones, such as the expected topline results for BX004 in Q1 2026. Finance: draft 13-week cash view by Friday.

BiomX Inc. (PHGE) - Canvas Business Model: Customer Segments

You're looking at the core groups BiomX Inc. (PHGE) is targeting with its phage therapies, which is critical because their current cash runway only extends into the first quarter of 2026, making segment focus a matter of survival. The company's strategy hinges on demonstrating value in these specific, high-need patient populations to secure future funding.

Cystic Fibrosis patients with chronic P. aeruginosa pulmonary infections.

This segment is targeted with BX004. BiomX estimates the global addressable market for this program at $1.6 billion. The clinical need is stark; in their Phase 1b/2a study, 14.3% of treated patients achieved complete bacterial clearance for P. aeruginosa after just 10 days, versus 0% for placebo. The overall global cystic fibrosis therapeutics market was valued at USD 13.78 billion in 2025, showing the scale of the overall therapeutic area.

Diabetic patients with S. aureus-driven Diabetic Foot Infections (DFI).

This is the focus for BX011 (also referred to as BX211 in earlier trial contexts). BiomX sees a global addressable market exceeding $2.5 billion here. To give you a sense of the problem they are tackling, company data suggests that in the U.S. alone, 85% of the approximately 160,000 annual lower limb amputations in diabetic patients are caused by DFI or diabetic foot osteomyelitis, representing an $8 billion annual healthcare burden. The broader diabetic foot ulcer treatment market reached USD 8.83 billion in 2024.

U.S. Military/Defense sector for combat-related wound infections.

This segment represents a strategic, non-dilutive revenue source and validation point. The development of BX011 for S. aureus in DFI has already secured approximately $40 million in non-dilutive funding from the U.S. Defense Health Agency (DHA). This funding highlights the urgent need the Department of Defense sees for new treatments against resistant infections in conflict environments.

Large pharmaceutical companies seeking novel anti-infective assets.

These companies are the ultimate potential partners or acquirers, looking for de-risked, novel assets to bolster their pipelines against antimicrobial resistance. BiomX's progress, such as receiving positive FDA feedback on the Phase 3 pathway for BX011 in October 2025, makes the asset more attractive. The company's operational burn rate-net cash used in operating activities for the nine months ended September 30, 2025, was $22.0 million-means that securing a partnership with a large pharma entity is a key near-term action to extend runway beyond Q1 2026.

Here's a quick look at the market context and funding supporting these segments as of late 2025:

You need to track the patient populations these numbers represent, which drives the ultimate commercial value. The key patient groups BiomX Inc. is focused on include:

• CF patients with chronic P. aeruginosa infections.
• Diabetic patients with S. aureus-driven DFI.
• Military personnel/veterans needing combat wound infection solutions.

BiomX Inc. (PHGE) - Canvas Business Model: Cost Structure

You're looking at the cost side of BiomX Inc. (PHGE) as of late 2025. The primary costs are centered on advancing the clinical pipeline, which means R&D dominates the operating expenses, while G&A covers the corporate overhead needed to run a clinical-stage biotech.

Here is a breakdown of the key reported costs for the third quarter ended September 30, 2025:

The Research and Development expenses, net for the third quarter of 2025 were $6.1 million, which was a reduction from $7.3 million in the third quarter of 2024. This reduction reflects active cost management within the R&D function.

General and Administrative expenses for the third quarter of 2025 were $2.4 million, down from $3.2 million in the third quarter of 2024. This decrease is tied to specific overhead reductions.

The costs associated with the clinical pipeline are the main drivers within R&D. Specifically, the cost structure includes:

• Clinical trial expenses for Phase 2b study of BX004 for cystic fibrosis, which commenced dosing in July 2025, though U.S. trial sites were placed on a clinical hold by the FDA.
• Clinical trial expenses for the BX011 program for diabetic foot infections (DFI), with planning underway for a Phase 2a trial subject to available resources.

Manufacturing and quality control costs for phage cocktails are embedded within R&D expenses. The decrease in R&D expenses for Q3 2025 was specifically attributed to lower manufacturing costs related to the BX004 product candidate.

Intellectual property maintenance and legal fees are captured within the G&A line item. The reduction in G&A expenses for the quarter was driven in part by lower legal and other professional service fees.

BiomX Inc. (PHGE) - Canvas Business Model: Revenue Streams

You're looking at the revenue streams for BiomX Inc. (PHGE) as of late 2025, and honestly, it's all about non-commercial funding right now. The top-line is driven by external sources while the phage therapies are still in clinical development.

The primary sources of revenue currently are not product sales, but rather support from government and industry partners:

• Grant funding from government entities, specifically noting decreased funding from the Medical Technology Enterprise Consortium under the DHA and the Israeli Innovation Authority.
• Collaboration revenue from pharmaceutical partners, including plans to advance BX011 in collaboration with the Defense Health Agency.

For the third quarter of 2025 (Q3 2025), the total revenue reported was $0.4 million. This figure is primarily composed of that grant income and collaboration revenue.

You can see the key revenue components and the most recent reported total in this snapshot:

Looking ahead, the model anticipates revenue from future milestone payments tied to licensing deals, though specific amounts aren't public yet. Still, the biggest potential shift in the revenue profile would come from commercialization.

• Future product sales from commercialized phage therapies are currently reported as $0.0.

Finance: draft scenario analysis on milestone payment timing versus cash burn rate by Monday.