BiomX Inc.

or as 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 two decades. Additionally, BFI 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 BFI 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 non-clinical 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 biomics precision phage therapy and strengthen our confidence as we look ahead for the upcoming VX004 phase 2b 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 thank you, 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 30th, 2025 were $8.1 million compared to $18 million as of December 31st, 2024. The decrease was primarily due to net cash used in operating activities. Biomics 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 DAA 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 nine months ended September 30, 2025, with $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-prone infection patients. large and commercially significant population. With increasing validation across the phage therapy space, Biomics looks forward to the upcoming BXO4 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 earning call. And with that, we'd like to open up for questions.

If you'd like to ask a question at this time, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from Joe Pantginnis with HC Wainwright.

Hey, good morning, Jonathan and Marina. Thanks for taking the question. 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. 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 has the potential to be independent development through defense?

Joe, good morning. 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 in, you know, the endpoints that we've discussed are all about soft tissue, so there's 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 um to get to approval right so that's their view they will hopefully continue right they support it with 40 million dollars to date uh hopefully they'll continue to support in a meaningful amount uh in the future and that would be an approach um which is diabetic foot infection it's not you know like combat wounds that would be something that we'll look to do together probably later um and it also i think bodes well for the discussion that we did have about the product 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 will 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. Thanks. And then my second question before I switch to my one for 004. So at 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 know, 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 want to consult with the DHA and make sure we're aligned. So I think that's kind of the next step. But in terms of regulatory feedback, we got all the feedback we wanted. you know, 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, you know, 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 DAJ to lay out the next study.

Great. Thanks for that. 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 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. It understands the difficulties and the challenges 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, you know, I mean, we've talked about bronchactasis 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, you know, it is an unmet need. Show us a clinical signal and enrich population and potentially, right, we could think about a broader label.

Great. Appreciate the comments, Jonathan.

You bet. Always a pleasure.

Our next question comes from Yale Jen with Laidlaw.

Good morning and thanks for taking the questions. I'm just going to follow up. but Joe has asked a little bit in more details. The first one is for the 011 in DFI. Does FDA feel that the current mix of phage was good, or would you guys all thinking maybe tweaking that a little bit, given that, you know, that setup was a little bit early, 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 a 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 others have experienced actually an update of the phage cocktail 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 BXO4. 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

know the support from the regulatory agencies as well as our experience specifically in staff for us and in cocktails in general okay great that's a very helpful in terms of clarify that maybe one question on zero zero four actually two of them so the first one is the initial clinical how uh i understand that just for the nebulizer and uh would you speculate why FDA feels they need to put, you know, at least temporarily put something in there. Was there any, do you know what that mindset was? And then I follow up on the, have another follow up.

Sure. So obviously it's a challenging situation, especially as this is like a very commonly used nebulizer that I see 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 was some additional data required from the nebulizer of tests that we provided, and it seemed 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 BXO4 specifically. So I think it's technical, right? We don't know for sure, and that's what we expect that imminently, you know, hopefully, right, imminently the hold will be lifted. Okay.

Okay, great. And I think that's just a little bit, I assume, a 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 three study, I know there's probably still a lot of, you know, moving parts there yet. But nevertheless, was there any sort of general idea in terms of the size of the study? your region of the treatment or any other color you can reveal.

And thanks. Sure. So I think we can't go too much into details, you know, as we're thinking. But, you know, we have a rough understanding of how does the phase three, of course, everything depends on the outcome of the phase two B. But, you know, it's an orphan indication. We know phage is safe. We've got all 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 paths to try to get this thing moving. Again, I think here we're benefiting so much from the help of the CF Foundation. It's 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? 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, you know, pending positive data in Phase 2B, 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 of luck for you guys.

Thank you, Greta. Really, really appreciate it.

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.