BiomX Inc. Q3 FY2025 Earnings Call

Good morning, and welcome to BiomX Third Quarter 2025 Financial Results and Program Update Conference Call. As a reminder, this conference call is being recorded. I would now like to turn the call over to Marina Wolfson, Chief Financial Officer of BiomX. Please proceed.

Thank you, and welcome to the BiomX conference call to review the company's third quarter 2025 financial results and provide an update on our business and programs. Later today, we will file the quarterly report on Form 10-Q with the Securities and Exchange Commission. In addition, the press release became available at 7:30 a.m. Eastern Time today and can be found on our website on biomx.com. A replay of this call will also be available in the Investors section of our website. As we begin, I'd like to review the safe harbor provision. All statements on this call that are not factual historic statements may be deemed forward-looking statements. For instance, we're using forward-looking statements when we discuss on the conference call the sufficiency of the company's cash, our pipeline, momentum and milestones, the design, recruitment aim, expected timing and interim and final results of our clinical trials, the timing of the lifting of the FDA clinical hold, if at all, the magnitude of the FDA basis to impose a clinical hold and resumption of the BX004 clinical trial, expected feedback from the FDA and additional regulatory agencies and results thereof, the potential benefits of our product candidates, including the potential that they would become an off-the-shelf formulation intended for broad outpatient use in diabetic foot infection, the potential safety or efficacy of our product candidate, BX004, BX011, and BX211, and the potential market and partnering opportunities for our product candidates. In addition, past and current clinical results as well as compassionate use are not indicative and do not guarantee future success of our clinical trials. Except as required by law, we do not undertake to update forward-looking statements. The full safe harbor provision, including risks that could cause actual results to differ from these forward-looking statements, are outlined in today's press release, which as noted earlier, is on our website. Joining me on the call this morning is BiomX's Chief Executive Officer, Jonathan Solomon, to whom I will now turn over the call.

Thank you, Marina, and thank you all for joining BiomX Third Quarter 2025 update today. The third quarter of 2025 has been an important period for BiomX as we continue to advance our clinical programs and engage with regulatory authorities on the pathway forward for our phage therapy clinical pipeline. Starting with our lead program, BX004 for the treatment of cystic fibrosis patients with Pseudomonas aeruginosa infections. Throughout the quarter, the program made important progress while navigating some regulatory challenges. We began the quarter strongly with first patient dosing in our Phase IIb trial, a significant milestone in the development of this innovative phage therapy. As the trial progressed, we received notification in August that the FDA has placed a clinical hold on our U.S. trial sites. This hold relates solely to the third-party nebulizer device used to deliver BX004, not to the drug candidate itself. Importantly, the FDA raised no concern about BX004 in their notification. So we see this as a technical challenge, but not a fundamental concern when it comes to our approach to our trial. We promptly submitted the requested nebulizer data and responded promptly to additional clarification requests and expect FDA feedback imminently. While this temporary pause affects our U.S. sites, we're optimistic about resuming enrollment soon. Since all components of the nebulizer are CE marked in Europe, our European trial continues uninterrupted and in full compliance with protocol requirements. Our European enrollment continues to progress according to plan. As reported just a few weeks ago, in October, we received written feedback from the FDA detailing the agency's understanding of the substantial unmet need for treatments targeting chronic Pseudomonas aeruginosa infection in CF patients, even with existing CFTR, cystic fibrosis transmembrane conductance regulator modulators. As part of that feedback, the FDA outlined several potential development pathways for BX004, including specific approaches for our Phase III inclusion criteria to demonstrate therapeutic benefits. This constructive feedback was encouraging for us as it provided both valuable guidance on how the FDA sees development for our program while recognizing its relevance to an important medical need, which we see as a vote of confidence. Following our BX004 Phase IIb readout, we plan to incorporate the FDA's recommendation into our development strategy and look forward to further discussion at our end of Phase II meeting. As of today, we are still on track to report the data in Q1 2026, notwithstanding the halt, which we expect to hear feedback from the FDA imminently, as I noted. Let us now turn to an exciting development in our second program. In early November, we reported positive FDA feedback on our plan to target Staphylococcus aureus infection in diabetic foot infections or DFI. This feedback supports our strategy to develop BX011, our next-generation fixed-phage cocktail designed specifically for this difficult-to-treat condition. BX011 represents a natural extension of our Phase II clinical success with BX211 in diabetic foot osteomyelitis, targeting the same Staphylococcus aureus pathogen, but in an earlier stage of the disease where the infection remains localized to the ulcer. The program advances toward an off-the-shelf formulation intended for broad outpatient use in diabetic foot infections while also offering dual-use potential as a rapidly deployable solution for treating combat-related wound infections as an approach well aligned with the priorities of the U.S. Defense Health Agency, or DHA, for future conflict environments. I want to take a minute to explain why we're targeting DFI initially. The DFI indication addresses a critical unmet medical need. Approximately 160,000 lower limb amputations occur in diabetic patients in the U.S. annually, with 85% stemming from diabetic foot infections or osteomyelitis. Despite this urgent need, no new drugs have been approved for DFI in the U.S. in over 2 decades. Additionally, DFI patients represent a large addressable patient population with significant commercial opportunity with a regulatory pathway that's clearly supported by established FDA guidance. These factors make DFI a strategically compelling indication for our program to focus on while leveraging the strong clinical data we already have. The FDA provided detailed constructive guidance for BX011, outlining the clear potential pathway toward a BLA, Biologics License Application. Notably, no additional nonclinical studies were requested and their CMC comments are aligned with our established manufacturing approach. This feedback confirms our development plan harmonizes with current FDA guidance for DFI product development. BX011 will be applied topically and includes proprietary phage previously evaluated in our successful BX211 study. We plan to advance BX011 in coordination with ongoing discussion with the DHA and subject to securing necessary financial resources. Looking more broadly at the landscape, we're seeing strong momentum across the phage therapy field alongside rising global attention to antimicrobial resistance. We think this underscores the growing validation of phage-based approaches such as ours. This broader progress across the industry validates BiomX's precision phage therapy and strengthens our confidence as we look ahead for the upcoming BX004 Phase IIb readout. I'd like to now pass you to Marina to review our third quarter 2025 financial results.

Thank you, Jonathan. As a reminder, the financial information for the company's third quarter 2025 is available in the press release that we issued earlier today as well as in more detail in our Form 10-Q, which we will file later today. I will now proceed with the highlights of our third quarter financial results. Our cash balance and restricted cash as of September 30, 2025, were $8.1 million compared to $18 million as of December 31, 2024. The decrease was primarily due to net cash used in operating activities. BiomX estimates its cash, cash equivalents, and restricted cash are sufficient to fund its operations into the first quarter of 2026. Research and development expenses net were $6.1 million for the third quarter of 2025 compared to $7.3 million for the third quarter of 2024. The decrease was primarily driven by reduced salary expenses due to workforce reduction, lower rent expenses following a right-of-use asset impairment in 2024, and decreased expenses related to the CF product candidate, primarily due to the significantly higher manufacturing costs that were incurred in 2024. Such decrease was partially offset by an increase in depreciation expenses attributable to an accelerated depreciation of leasehold improvements resulting from the modification of our office lease agreement in Israel as well as by decreased grant funding from the Medical Technology Enterprise Consortium under the DHA and the Israeli Innovation Authority. General and administrative expenses were $2.4 million for the third quarter of 2025 compared to $3.2 million for the third quarter of 2024. The decrease was primarily driven by reduced salary and share-based compensation expenses and lower legal and other professional service fees. The decrease was partially offset by an increase in depreciation expenses attributable to the accelerated depreciation of leasehold improvements resulting from the modification of our office lease agreement in Israel. Net loss was $9.2 million for the third quarter of 2025 compared to net income of $9.6 million for the third quarter of 2024. The decrease was mainly due to the change in the fair value of warrants issued as part of the company's March 2024 financing. Net cash used in operating activities for the 9 months ended September 30, 2025, was $22 million compared to $30.7 million for the same period in 2024. I'll now return the call to Jonathan for his closing remarks.

Thanks, Marina. To summarize, our focus remains strongly on clinical and regulatory execution, advancing both BX004 and BX011 through key upcoming milestones. We anticipate feedback imminently on the BX004 clinical hold in the U.S., which could enable the resumption of enrollment in the near term. In parallel, encouraging FDA guidance has outlined clear Phase III development pathways for BX004 and strengthened the regulatory and commercial opportunity for BX011, which will focus on diabetic foot infection patients, a large and commercially significant population. With increasing validation across the phage therapy space, BiomX looks forward to the upcoming BX004 trial readout in the coming months and the continued progress toward bringing precision phage therapies to patients in need. Thank you all for joining today's earnings call. And with that, we'd like to open up for questions.

Our first question comes from Joe Pantginis with H.C. Wainwright.

So a few questions right now. You've got a lot of working parts, and it's really nice to see all the regulatory progress. So maybe I'll start with DFI. It's good we have the clarity on the potential path forward. So I have two questions there. With regard to the defense potential, is this something that you might look to do in parallel with your clinical program? Or does this have the potential to be independent development through defense?

It’s quite cold in New York this morning. One of the interesting aspects of the DHA is that they recognize that the most effective way to gain product approval is by first supporting it in a commercial setting. They essentially indicate that if the quickest route to approval for the drug is through diabetic foot infections, they will back that path, leading to approval, and there will always be opportunities to broaden the indications later. This approach feels very refreshing and practical. In our discussion with them, we mentioned that we are considering data on diabetic foot osteomyelitis and that the endpoints are primarily focused on soft tissue. We are very optimistic about the diabetic foot infection area. We asked for their perspective, and they confirmed that it is indeed more relevant to combat wounds. They reiterated their support for whatever route we believe will expedite our approval process. I hope this clarifies things.

No, it certainly does. And then my second question before I switch to my one for 004. So on DFI, are there any outstanding questions? It seems like you have pretty good clarity right now or very good clarity. But are there any outstanding questions that still need to be addressed with regard to potential design or inclusion criteria?

There has been some fine-tuning, but generally speaking, there was a clear guideline on DFI that outlines the endpoints. Some of the composite endpoints can be adjusted, but there is a solid understanding of what is required. The FDA has been explicit, so we know what the clinical study will entail. We are in consultation with the DHA to ensure alignment, which is our next step. Regarding regulatory feedback, we received everything we needed consistent with CMC aspects, which we are quite comfortable with. Additionally, there is reassurance that there is no need to conduct animal safety studies or skin penetration tests, which simplifies things. We feel that everything is aligned, and now we look forward to collaborating with the DHA to plan the next study.

Great. And then my question on 004. It's pretty intriguing to us regarding the FDA feedback right now. So I'm hoping you might be able to provide a little more color even though it's a bit early for this on next steps with regard to how you might enrich the population or optimize it as you put it.

We are very grateful for the feedback from the FDA. It's clear that they recognize the significant unmet need, as evidenced by the number of participants noted in their documentation. Patients are eager to join the study because they understand the serious consequences of contracting Pseudomonas infections, and they are motivated to eliminate these pathogens. The FDA is aware of the challenges posed by CFTR modulators, and they seem open to the idea of enriching the patient population. For instance, we've discussed bronchiectasis as a promising indication. We could focus on patients who are not on CFTR modulators and those experiencing more exacerbations to capture a clinical signal in this group, which might lead to a broader approval. This understanding from the FDA about the unmet need and the possibility of demonstrating a clinical signal in a more targeted population is something we greatly appreciate, as it could allow us to consider a wider label in the future.

Our next question comes from Yale Jen with Laidlaw.

I'm just going to follow up what Joe has asked a little bit in more detail. The first one is for the 011 in DFI. Does the FDA feel that the current mix of phage was good? Or would you guys think maybe tweaking that a little bit given that the setup was built up a little bit earlier? And then I have a follow-up.

We feel very comfortable regarding Staph aureus. This is one of those bacteria where only a few phages provide broad coverage, so we don't believe we need an extensive cocktail based on our experience. We can use just a few phages from the previous study to create a viable product. Overall, the FDA has been quite supportive of phage cocktails. We've experienced and observed others experiencing successful updates to phage cocktails during clinical development without any major issues or the need to return for safety studies. Our experience with expanding BX004 has been positive, and other phage companies have reported similar experiences publicly. Therefore, we do not expect any challenges. We are confident both in the support from regulatory agencies and in our expertise, particularly with Staph aureus and cocktail formulations in general.

Okay, that's very helpful in clarifying that. I have a question about BX004, actually two of them. The first one concerns the initial clinical hold; I understand that it's just regarding the nebulizer. Can you speculate on why the FDA chose to implement a temporary hold? Do you have any insight into their reasoning? And then I have another follow-up.

Sure. So obviously, it's a challenging situation, especially as this is like a very commonly used nebulizer that is CE marked in Europe. And we see that with the trial kind of proceeding well in Europe and recruitment kind of speeding up beyond our expectation and kind of catching up with our timeline. Again, I don't know for sure. Our speculation is there has been some new set of requirements that were asked a few months ago, and that sort of just required additional data. So I think the concern just because there were some additional data required from the nebulizer of tests that we provided and seem to be very technical, and what we've seen and provided is all within scope. So we view it as very technical. Again, only about the nebulizer, no questions whatsoever about phage or BX004 specifically. So I think it's technical, right? We don't know for sure. And that's why we expect that imminently, hopefully, right, imminently, the hold will be lifted.

Okay. Great. I think there may have been some minor issues along the way. My last question is regarding your discussions with the FDA about the potential Phase III study. I understand there are still many factors in play, but can you share any general information about the study's size, treatment duration, or any other details?

Sure. While we can't provide too many specifics at this time, we do have a general understanding of how the Phase III will proceed, although everything hinges on the results of the Phase IIb. Since this involves an orphan indication, we know that phage is safe and have a good foundational understanding, so we hope for a quicker development timeline. We've also been greatly aided by the CF Foundation, which is actively engaging with the agency and supporting us in various ways. Overall, we believe the path forward is relatively clear and straightforward, contingent upon obtaining strong data. Additionally, there has been a noticeable increase in pharmaceutical interest in respiratory conditions, reflected in recent transactions and successes in the field. We are also witnessing a surge in attention towards phage therapy, with our successes and those of others contributing to this momentum. Therefore, with positive Phase IIb data, we see an exciting opportunity ahead, whether in cystic fibrosis or NCFB, depending on various factors like our setup, financing, and potential collaborations.

Okay. Great. That's very helpful. Again, congrats on all the progress and the best luck for you guys.

That concludes today's question-and-answer session. I'd like to turn the call back to Jonathan Solomon for closing remarks.

So I wanted to thank you all for joining us this morning. Wishing everyone happy holidays, and we look forward to reporting on our next developments. Thank you so much.

This concludes today's conference call. Thank you for participating. You may now disconnect.