BiomX Inc. (PHGE) Q3 2025 Earnings Report, Transcript and Summary

Good morning, and welcome to BiomX Third Quarter 2025 Financial Results and Program Update Conference Call. [Operator Instructions] 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 on 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 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 third-party nebulizer device used to deliver BX004, not to a 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 pathway 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 and 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 disease where 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 infection 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 infection 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 strengthen 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 a clear Phase III development pathways for BX004 and strengthened the regulatory and commercial opportunity for BX011, which will focus on diabetic for infection patients, 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.

[Operator Instructions] 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 2 questions there. With regard to the defense potential, is this something that you might look to do in parallel with your clinical program? Or is this has the potential to be independent development through defense?

Quite chilly in New York this morning. So it's actually -- I think that's one of the really interesting aspects of the DHA, right? So they understand, unlike other agencies, that the best way to get a product approved is to support it first in a commercial indication. So they kind of say, look, if the fastest path to get the drug approved is diabetic foot infections, we'll actually support that, get the drug approved and then we can always kind of expand the indication later, right? So I think that's a very refreshing approach and very practical. So we had this conversation with them and kind of said, look, we're debating, we have data in diabetic foot osteo. We have data -- the endpoints, as we've discussed, are all about soft tissue. So there are diabetic foot infection endpoints. We're really excited about diabetic foot infection. Does it make sense for you guys? And they're like, yes, it's actually closer to combat wounds. But again, they kind of reiterate, we'll support whatever you think is the fastest path to get to approval, right? So that's their view. They will hopefully continue -- right, they supported with $40 million to date. Hopefully, they'll continue to support in a meaningful amount in the future. And that would be an approach which is diabetic foot infection. It's not like combat wounds. That would be something that we'll look to do together probably later. And it also, I think, bodes well for the discussion that we did have about the products because we said the existing work on BX211 was a personalized approach. We have a lot of experience with Staph aureus. We know how to do a broad cocktail and an off-the-shelf product, and that's what we think we'll move to BX011 using the phage that we used in the trial. They're like, yes, because we view that it's more likely that an off-the-shelf product makes sense for combat settings, right? But still, they want to see us pursue diabetic foot first, get the drug approved and then sort of expand it later. So I hope that helps clarify.

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's some fine-tuning, but generally, right, as you kind of note, right, first, there was a guideline, which is very clear on DFI, right? So the guideline kind of states the endpoints. You can always tweak some of the composite endpoints, but there's pretty good understanding. The FDA was very clear. So we do know how the clinical study is going to look like. Of course, we're on consult with the DHA and make sure we're aligned. And that -- so I think that's kind of the next step. But in terms of regulatory feedback, we got all the feedback we want consistent with CMC aspects, which we know and feel very comfortable. And of course, the reassurance that there's no need to do animal safeties or some of the skin penetration, it's pretty straightforward. So we feel that it's aligned. I think the feedback was consistent. And I think now we look forward to kind of working together with the DHA to lay out 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.

Sure. So I do think we're super appreciative of the feedback that came to the FDA, right? I think it's thoughtful. You could see as the number of participants just in the document that was provided by the FDA. And again, they understand it's a huge unmet need, right? We're seeing it in the clinical study, right? Patients want to go on the study. They know that getting one of these nasty Pseudomonas is a really bad outcome, right? And they're willing to do whatever they can to get rid of those Pseudomonas. And the FDA understands it, appreciates it. They understand the difficulties in the age of CFTR modulators. And I think that's where they're open, right, to say, hey, you could potentially enrich the patient population with -- I mean, we've talked about bronchiectasis being a really interesting indication. You could look at patients which are not taking CFTR modulators, patients who are exacerbating more and try to get the clinical signal there where it's easier and hopefully get a broader approval. So that's kind of the thinking around enrichment. And I think that's why we're so appreciative of the FDA kind of taking a step forward and understanding it is an unmet need, show us a clinical signal in an enriched population and potentially, right, we could think about a broader label.

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 felt that the current mix of phage was good? Or would you guys are thinking maybe tweaking that a little bit given that the setup was built up a little bit earlier? And then I have a follow-up.

Sure. So I think specifically with Staph aureus, we feel very comfortable. It's one of these bacteria that very few numbers of phage get broad coverage, right? So I don't think we need a very extensive phage cocktail based on our experience. And we can use just a few phage that we used in the previous study, put together a product that moves forward. Generally, I will say the FDA has been very supportive in terms of phage cocktails, right? So we've seen -- we've experienced and other experienced that actually an update of the phage cocktails through clinical development without a problem, without needing to go back, without needing to do any safety studies. So we've shown -- we've had that experience of expanding BX004. As I said, other phage companies had the same experience that was reported publicly. So no, we don't anticipate any challenges there. I think we feel very comfortable both with the support from the regulatory agencies as well as our experience, specifically in Staph aureus and in cocktails in general.

Okay. Great. That's very helpful in terms of clarify that. Maybe one question on 004, actually, 2 of them. So the first one is the initial clinical hold, I understand that just for the nebulizer. And would you speculate why FDA feel they need to put at least temporarily put something in there? Was there any -- do you know what their mindset was? And then a follow up on the -- 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 time line. 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 test 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. And I think that's just a little bit -- I assume nuisance happened along the way. And then maybe the last question here is that given that you have a discussion with the FDA about the potential Phase III study. I know there's probably still a lot of moving parts there yet. But nevertheless, was there any sort of general idea in terms of the size of the study, duration of the treatment or any other color you can reveal?

Sure. So I think we can't go too much into details as we're thinking, but we have a rough understanding of how does the Phase III -- of course, everything depends on the outcome of the Phase IIb. But it's an orphan indication. We know phage is safe. We've got all of the understanding. So hopefully, it's a shorter development path, right? It's an orphan indication, as I mentioned. So there are all the regulatory sort of path to try to get this thing moving. Again, I think here, we're benefiting so much from the help of the CF Foundation, is actively discussing with the agency as well as with us and supporting us in many ways. So I think it's a relatively well-defined and straightforward path, of course, pending good data. And you know what we're also seeing, and I'm sure you're feeling it as well, right, there's a lot of increased pharma interest in respiratory. We've seen some of the interesting transaction that happened in respiratory, and we're seeing that interest, right? So there is robust pharma interest in that indication, right? We talked about CF and NCFB with some of the recent success and approvals in that field. And also, I think as we're seeing, there's increased phage interest, right? There's success by us and others which is helping. So I think it's kind of converging to a lot of interest pending positive data in Phase IIb that there's a really interesting path forward. It could be in CF, it could be in NCFB, and it all depends on the setup, the financing and potential partnerships.

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.