BiomX Inc. (AMEX:PHGE) Q2 2025 Earnings Call Transcript

BiomX Inc. (AMEX:PHGE) Q2 2025 Earnings Call Transcript August 13, 2025

BiomX Inc. beats earnings expectations. Reported EPS is $-0.19, expectations were $-0.33.

Operator: Good morning, and welcome to the BiomX Second Quarter 2025 Financial Results and Business 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.

Marina Wolfson: Thank you, and welcome to the BiomX conference call to review the company’s second 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 6:30 a.m. Eastern Time today and can be found on our website at 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, expected feedback from the FDA and additional regulatory agencies and results thereof, the potential benefits of our product candidates, the potential safety or efficacy or product candidates, BX004 and BX211, and the potential markets 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 provisions, 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.

Jonathan Eitan Solomon: Thank you, Marina and thank you all for joining BiomX Second Quarter 2025 update today. The second quarter of 2025 has been a productive period for BiomX as we continue to advance our clinical programs and build scientific validation for our phage therapy platform. During the quarter, we made important progress on both our BX004 and BX211 programs and have positioned ourselves well for the upcoming milestones. Since the end of the quarter, we achieved a critical milestone with a successful initiation of patient dosing in our Phase IIb clinical trial of BX004 for cystic fibrosis patients, an important step as we advance our top line results expected in the first quarter of 2026. We also published additional data from our BX004 Phase Ib/IIa study in Nature Communications in July, providing further validation of our phage therapy platform.

Let me start by reviewing the recent progress across our clinical pipeline. We launched into the second quarter with a virtual key opinion leader event to discuss the positive top line Phase II results for BX211 that were reported in March 2025. The event received resounding endorsement from key opinion leaders, physicians and industry experts highlighting the enthusiasm surrounding the strength of the data and the significant potential addressing the needs of patients living with diabetic foot osteomyelitis or DFO. To recap, those March results demonstrated that BX211 was safe and well tolerated and produced sustained and statistically significant percent area reduction in ulcer size with a p-value of 0.046 at week 12 and 0.052 at week 13.

We saw separation from placebo starting at week 7, with a difference greater than 40% by week 10. The results showed statistically significant improvement in both ulcer death at week 13 in patients with ulcer death, defined as bone at baseline with a p-value of 0.048, reducing the expansion of ulcer area with a p-value of 0.017 compared to placebo. As background on the significance of this program, DFO is an extremely challenging indication with substantial unmet patient need. Each year, there are approximately 160,000 lower limb amputations in diabetic patients in the U.S. alone with 85% estimated to be caused either by DFO or diabetic foot infections. No therapeutics have been improved in the United States, specifically for the treatment of DFO in over 20 years.

Following the positive Phase II results, we are now engaged in continued discussion with the U.S. Defense Health Agency, a key financer and supporter driving the development of BX211 program. And in parallel, we’re currently planning for BX211 registrational study, pending discussion and feedback from the FDA. The second quarter also marked with continuous advancement for our Phase IIb trial of BX004, which included the successful initiation of patient dosing in this Phase IIb trial, a critical milestone for our cystic fibrosis or CF program, aligning with our time line of expected top line results from the Phase IIb results in the first quarter of 2026. We are encouraged by the high level of enthusiasm for enrollment in the Phase IIb CF trial across the board for both patients and investigators driven by the strength of a prior Phase Ib/IIa data in which 14.3% of patient cleared infections completely after 10 days of treatment.

The design of the Phase IIb trial of BX004 for the treatment of patients with cystic fibrosis infection associated with Pseudomonas aeruginosa is designed as a randomized, double-blind, placebo-controlled multicenter study in approximately 60 cystic fibrosis patients with chronic Pseudomonas aeruginosa infections. Patients in the trial will be randomized at a 2:1 ratio to receive either BX004 or placebo via inhalation twice daily for 8 weeks. The trial is designed to measure multiple efficacy endpoints, including reduction in bacterial burden, improvement in lung function and enhanced quality of life as measured by patient questionnaires. In July, we published in a highly acclaimed nature communication publication. The paper included new findings from our Phase Ib/ IIa trial, showcasing previously unreported antimicrobial efficacy data that demonstrated BX004 achieving a substantially greater improvement of approximately 500 fold.

That’s a 2.7 log reduction in bacterial reduction compared to placebo in CF patients. Importantly, the data also highlights no bacterial resistance to BX004 emerged during the trial. The article also details our innovative approach to large-scale data analysis in order to optimize bacteria phage cocktails. We believe that this publication in one of the highly prestigious scientific journals, represents an important validation for our phage platform and methodology from broader scientific community. We continue to press forward with the execution of the BX004 trial. And in parallel, we expect to receive feedback from the U.S. FDA regarding the potential investigation and use of real-world evidence linking material reduction to clinical outcomes during the second half of 2025, bring us closer to addressing the urgent unmet need of patients with pseudomonas aeruginosa, CF infections sooner.

The combined progress across our clinical pipeline during the second quarter, in addition to recent achievement in July, reinforces our approach and gives us strong momentum as we advance towards our next milestones. I’d like to now pass you on to Marina to review our second quarter 2025 financial results.

Marina Wolfson: Thank you, Jonathan. As a reminder, the financial information for the company’s second 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 second quarter financial results. Cash balance and restricted cash as of June 30, 2025, were $15.2 million compared to $18 million as of December 31, 2024. The decrease was primarily due to net cash used in operating activities. We estimate that our cash, cash equivalents and restricted cash are sufficient to fund our operations into the first quarter of 2026. Research and development expenses net were $5 million for the second quarter of 2025 compared to $6.9 million for the second quarter of 2024.

The decrease was primarily driven by reduced salary expenses from workforce reductions, lower rent expenses following 2024 right-of-use asset impairment accounting and increased grant funding from the Medical Technology Enterprise Consortium and the Israel Innovation Authority. This was partially offset by higher expenses from initiating the Phase IIb clinical trial for CF product candidate, BX004. General and administrative expenses were $2.4 million for the second quarter of 2025 compared to $2.8 million for the second quarter of 2024. The decrease was primarily attributed to a reduction in legal and other professional service fees, partially offset by increased share-based compensation expenses. Net loss was $6 million for the second quarter of 2025 compared to income of $4.5 million for the second 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 6 months ended June 30, 2025, was $14.8 million compared to $22.6 million for the same period in 2024. I’ll now return the call to Jonathan for his closing remarks.

Jonathan Eitan Solomon: Thanks, Marina. The second quarter of 2025 was a productive period for BiomX as we advance our clinical programs and build momentum for upcoming milestones. Since the end of the quarter, we have achieved important milestones, including the successful initiation of our BX004 Phase IIb trial and the publication of our data in Nature Communications, which we believe provides important scientific validation of our phage therapy platform from the global research community. With multiple value-creating catalysts ahead, including FDA feedback on our real-world evidence approach in the second half of 2025, ongoing collaboration discussion with the U.S. Defense Health Agency and BX004 Phase IIb top line results expected in the first quarter of 2026, we continue to advance our potentially life-changing therapeutics.

We appreciate the continued support of our shareholders and look forward to updating you on our progress. Thanks again to all who joined the call this morning. And with that, we’d like to open to questions.

Q&A Session

Operator: [Operator Instructions] Our first question comes from Joe Pantginis with H.C. Wainwright.

Joseph Pantginis: I have a couple, but I wanted to start with a bit of a macro question first regarding bacteria phage. So for the 004 study, you mentioned significant interest in the study. You have the Phase II data for 211. So I was just curious, based on the positive clinical data that you’ve delivered as well as others in the space, have you seen a relative inflection with regard to site and physician interest, with regard to wanting to be in the studies?

Jonathan Eitan Solomon: Joe, and I look forward to meeting you face-to-face in New York pretty soon on the conference. And you’re hitting the nail on the head. I think we’ve seen — in the past, you remember all our conversation, right? The previous CF studies took a while to recruit. Now sites are excited, patients are excited, physicians are excited. So it does seem very different. And again, I think it’s our prior data. I think it’s a data that others have generated. So I think there’s excitement around efficacy. There’s a greater level of comfort around safety, which we knew was a strong point of stage to begin with. And really sites are just — and patients are calling us all the time on top of like the standard compassionate use request to participate in the study.

So it is a very exciting time in the field. I think there’s a lot going on, right? I add to it like publications in very highly claimed journals, the fact that people are talking about it in the communities and the patient communities. And that also bleeds into like strategic interest, right? You remember all our conversations kind of waiting for this inflection point to come. I think we’re there, right? You never really know unless you have like historical perspective, but it does feel very different, right, both from patients, caretakers and even strategics that are now saying, wow, there’s actually data out there. There’s a few Phase IIs randomized placebo-controlled studies that are showing efficacy and all the kind of data sets that we wanted to see.

So I think it’s not an approved drug yet, but we’re definitely heading in the right direction. Let’s hope that momentum just keeps on going.

Joseph Pantginis: No, that’s great to hear and looking forward to seeing more out of the space. So with regard to 211, obviously, you still need to have further discussions with the FDA, but maybe provide a little bit of a wish list, if you will, with regard to what a registrational study might look like from your end, pending feedback as well as how are you looking to link that up with your ongoing discussions with the Defense Health Agency.

Jonathan Eitan Solomon: So obviously, I think it’s really — the data set that we’ve seen is really exciting, right? It’s one of those data sets that as a friend says, you just need to show one graph, right? And that is very significant. There’s a 40% reduction, which is statistical significant in a very tough indication, right? I think the path forward opens up — obviously, diabetic foot osteo is kind of a subset within diabetic foot infection. I think there’s a possibility to kind of advance in both paths. And that’s something we’re looking into and there’s ongoing prepping for the discussion with the regulatory agencies. So I think that path in some ways, is pretty laid out, right? There’s a specific guidance on diabetic foot infections and endpoints are around infection resolution.

But of course, we want to validate and have that discussion with the agency. I think we know how the next study potentially can look like to kind of go for a registrational study. To your point, right, and I think the DOJ has been great in sort of understanding that they can support — they don’t want to support indications where it’s solely for military use, right? They understand that the real path to success is to support programs that have a use in the private market or the standard market. So that’s why they’re supporting the diabetic foot. And there, they want to see a registrational study. They want to see a drug approved and then they can kind of use it in combat wound. So there’s great appreciation. I think there’s still more data that we’re getting, unfortunately, from the Ukraine war showing a lot of antibiotic resistance.

And when you look at the data that we have in our study, right, we’re looking at soft tissue, right? We looked at the ulcers. We saw the ulcers kind of shrink on all 3 dimensions. We’re seeing a lot of other parameters kind of adding up together to a very promising picture. And obviously, there’s excitement, and we’ll know formally where we are towards the end of the year. But the data looks very good. And I think there’s — we’re excited to kind of have the discussion with them and potentially have them to complete and so forth. I mean, to date, they’ve put in almost $40 million non-dilutive in the program. So quite dramatic support, and we’d never gotten to this point without them.

Joseph Pantginis: No, that’s great. Great feedback. And then my last question is around 004. And I guess I wanted to maybe get a little more color from you as well as those on the call with regard to the utility and what the FDA should be able to garner from the real-world evidence that you’re looking to provide them? Like what is the general use for that and the benefits for the program?

Jonathan Eitan Solomon: Right. So that’s a great question. I think we have seen in the past drugs that were either approved or conditionally approved or accelerated approval based on microbiology, right? Again, it’s not a trivial path to pursue. I think in CF, there is data historically that some of the antibiotics were approved either based on FEV1, so kind of improvement in clinical and breathing capacity of these patients as well as patient-reported outcome, right? So that’s been kind of the historical approvals in antibiotics. We have seen cases of approval on microbiology, which obviously kind of potentially can help accelerate the path going forward. There is quite a lot of data out there that supports the notion that patients that harbor bacterial infections have a worst outcome, worst prognosis, worst survival.

I — actually, there was just a recent paper that just came out. I was reading this morning exactly on even patients that are taking the modulators. We’re still seeing persistent infection of pseudomonas and this is a nasty bug, right? It’s not a good thing to have this thing in the lung. So I think we’re trying to sort of get alignment, get as much information as we can on historically, what do patients do look at registries in the U.S. and Europe and kind of gather all the information, trying to build the case and see whether there’s a path to somehow hasten and sort of get a shorter [ full path ]. Again, everything depends on discussion with the regulatory agency. It’s still early in the process, but we’re looking for some alignment in our thinking, whether it makes sense and whether we pursue that path going forward.

Operator: [Operator Instructions] Our next question comes from Yale Jen with Laidlaw & Company.

I-Eh Jen: Congrats to get the 004 program to start and, hopefully, finish in first quarter next year. Just a follow-up on the 004. I understand that the study just started in July, but any updates or preliminary look in terms of the enrollment status? And then I have some follow-ups as well.

Jonathan Eitan Solomon: Sure. So Yale, a pleasure as always. Usually, we don’t give guidance specifically, but I will say, as kind of Joe kind of brought up, there is excitement on the sites, right? So it is looking very good with a lot of patients waiting to be enrolled and excitement both from patients and their caretakers. So I think we are still in line with the time line and think that the data is going to be ready in the first quarter.

I-Eh Jen: Okay. Great. Maybe a little follow-up on Joe’s question as well. In terms of the real-world data you want to talk to FDA about, have you guys already done some work, maybe generate some documents that once — if the FDA would like to have a chance of chatting with you and you already have that sort of material ready and also with some sort of — whether there’s any dates or time has been set up for that discussion?

Jonathan Eitan Solomon: Great question. So it is an area of a lot of interest. As I mentioned, right, you see papers coming out, I’m just reading this morning a paper on this. On the company end, what we’re doing is kind of threefold, right? We had a panel of KOLs convened on this and had a discussion sort of provided the recommendation, which is part of our discussion with the regulatory agencies. There is work that we’re doing on real-world evidence, meaning that we are actively tapping into registries and gathering all the information, right, sort of tracking over a long period of time. Thirdly, a literature analysis, which obviously, there’s a lot of support that we’ve discussed in the past around this indication. So I think that’s really kind of interesting to see the presence of it here through the years.

And again, right, not surprising. We know it’s a very nasty bug. We also did a questionnaire of our care territories along — across the country. And again, it’s very clear, right? There is a reason why all these patients are being treated with antibiotics and they’re trying to kind of get rid of infections altogether. So I think all of that data kind of feeds into that discussion. Again, this is an ongoing process, and we’re getting alignment on this. I will also say, I think it’s really interesting as we’re having the discussion today, right, yesterday, for the first time, a drug was approved in NCFB in bronchiectasis. And there, again, you see all the analogy, right? All the articles that kind of say, hey, the presence of bacteria is going to lead to worse clinical outcomes, reduced survival, increased mortality.

And all that data is out there, right? So there’s a lot of analogy and I think a lot of excitement as we think about all these indications. And again, there is a lot of rationale why we don’t want these patients to have these bacteria and how detrimental it is. And what we’ve seen in the Phase IIa was that 14% of the patients got rid of infection altogether. That’s really exciting. So I think if we can replicate this kind of data, right, hopefully improve it because that was only in 10 days and this study is 2 months. Then we’re looking at quite an exciting value proposition, right, knock on wood that everything replicates and the interactions go the right way, but we’re very excited about the combination of the real-world evidence, hopefully, the clinical outcome and the data that we’ve seen.

And as we’ve tried it many times, right, the possibility to take to see a product and even extend it even further to a market, which is even greater.

I-Eh Jen: Okay. Great. And maybe I’ll just squeeze in one more. In terms of 211, you were preparing for the registration study. Just curious, what a general framework of that study might look like? And was there any time line that you will prepare for have a discussion with the FDA?

Jonathan Eitan Solomon: Yes. So we are interested in having that discussion in the second half, so by the end of this year. I think we’re gearing up to it. You do know, for example, when you’re looking at — again, right, you could kind of split and look at the DFI, in general, where there’s guidance and there’s a predefined endpoint, which is the infection resolution, which is supported by some of the data that we’ve seen, right? We’re seeing the ulcer shrink, but we see all the other parameters kind of improving. So that’s exciting, and I think that gives us like a broad framework of how to pursue. In diabetic foot osteo, you kind of look at a bit of a longer time frame and then you want to look at the whole infection resolution, which also includes like look at the bone with MRI and X-ray.

So there is a broad outline of what we need to do. And again, I think there is a guidance and thinking, we’ll talk to the FDA and sort of try to solidify, but there’s a very clear guidance document on this, right? So that’s very helpful, and we’re basically looking to kind of ratify our understanding. And again, some of the advisers that, including Benjamin Lipsky that was on our KOL call is one of the people that actually was involved in writing the guidance, right? So we feel we’re in good hands, but I got to verify and have the interaction and then sort of lay out a proper design.

I-Eh Jen: Okay. Great. That’s very helpful. And again, congrats on kick off the critical study and look forward to talking to you as well as seeing the data later on.

Jonathan Eitan Solomon: Thank you, Yale. We appreciate it.

Operator: I’m showing no further questions. I’d like to turn the call back over to Jonathan Solomon for any concluding remarks.

Jonathan Eitan Solomon: So I wanted to thank you all for joining us today. I look forward to keeping you posted about ongoing developments. Very exciting times in the field as the question sort of hopefully highlighted, and I hope you enjoy the rest of the summer. Thank you again.

Operator: Thank you for your participation. You may now disconnect. Everyone, have a great day.