BiomX Inc.

Good morning, and welcome to the Biomix second quarter 2025 financial results and business and program update conference call. Currently, all participants are in listen-only mode. At the end of this call, there will be a question and answer session. 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 Biomix. Please proceed.

Thank you. And welcome to the Biomics 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 biomics.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 in 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 of our 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 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 Biomics Chief Executive Officer Jonathan Solomon, to whom I will now turn over the call.

Thank you, Marina, and thank you all for joining Biomics' second quarter 2025 update today. The second quarter of 2025 has been a productive period for Bionics 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 2B clinical trial of BX004 for cystic fibrosis patients. An important step as we advance toward top-line results expected in the first quarter of 2026. We also published additional data from our BX004 Phase 1B2A study in Nature Communication in July, providing further validation of our phage therapy platforms. Let me start by reviewing the recent progress across our clinical pipeline. We launch into the second quarter with a virtual key opinion leader event to discuss the positive top line phase two results for BX211 that were reported in March 2025. The event received resounding endorsement from key opinion leaders, physician and industry experts highlighting the enthusiasm surrounding the strength of the data and the significant of its potential addressing the needs of patients living with diabetic foot osteomyelitis, or DFO. To recap, those MARSH results demonstrated that BX211 was safe and well-tolerated and produced sustained and statistically significant percent area reduction of 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 seven 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 approved 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 a 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 timeline of expected top-line results from the Phase 2b results in the first quarter of 2026. We are encouraged by the high-level enthusiasm for enrollment in the Phase 2b CF trial across the board from both patients and investigators, driven by the strength of our prior Phase 1b2a data, in which 14.3% of patients cleared infections completely after 10 days of treatment. The design of the Phase 2B 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, multi-center study in approximately 60 cystic fibrosis patients with chronic pseudomonas aeruginosa infections. Patients in the trial will be randomized at a 2 to 1 ratio to receive either BX004 or placebo via inhalation twice daily for eight 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 the highly acclaimed Nature Communication publication. The paper included new findings from our Phase 1b2a 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 bacteriophage cocktails. We believe that this publication in one of the highly prestigious scientific journals represents an important validation for a 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 US FDA regarding the potential investigation and use of real-world evidence linking material reduction to clinical outcomes during the second half of 2025, bringing us closer to addressing the urgent unmet need of patients with Pseudomonas aeruginosa CF infections sooner. The combined progress across the 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.

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 is 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 the 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 2B 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 six months ended June 30th, 2025 with $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.

Thanks, Marina. The second quarter of 2025 was a productive period for Biomix as we advanced our clinical programs and built momentum for upcoming milestones. Since the end of the quarter, we have achieved important milestones, including the successful initiation of our BX004 Phase 2b 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 a real-world evidence approach in the second half of 2025, ongoing collaboration discussion with the U.S. Defense Health Agency, and BX004 Phase 2B 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.

Thank you. If you'd like to ask a question, please press star 1-1. If your question has been answered and you'd like to remove yourself from the queue, please press star 1-1 again. Our first question comes from Joe Panginis with HC Wainwright. Your line is open.

Good morning, Jonathan and Marina. Thanks for taking the questions. I have a couple, but I wanted to start with a bit of a macro question first regarding bacteriophage. So, for the 004 study, you mentioned, you know, 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?

So, Joe, good morning. And I look forward to meeting you face-to-face in New York pretty soon in the conference. And you're hitting the nail on the head. I think we've seen – in the past, do 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 phase to begin with. and and really sites are just you know and patients are calling us all the time on top of like the standard compassion use request uh to participate in the study so it is a very exciting uh time in the field i think there's a lot going on right i add to it like publications and very highly acclaimed journals um the fact that people are talking about it in in the communities and patient communities And that also bleeds into like strategic interests, 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, you know, there's actually data out there. There's a few phase two's. randomized, placebo-controlled studies. They're showing efficacy and, you know, all the kind of data sets that we wanted to see. So I think, you know, 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.

No, that's great to hear and looking forward to seeing more out of the space. So with regard to 2-1-1, 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, you know, what a registrational study might look like from your end, pending feedback, as well as, you know, how are you looking to link that up with your ongoing discussions with the Defense Health Agency?

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, you know, as a friend says, you just need to share one graph, right? And and the day is very significant, there's a 40% reduction, which is statistically 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 what we're looking into, and there's ongoing, you know, prepping for the discussion with the regulatory agencies. So I think that path... In some ways, it's pretty laid out, right? There's a specific guidance on diabetic foot infections and endpoints 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 DHA 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. 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 they want to see a registrational study. They want to see a drug approved, and then they can kind of use it in combat wounds. So there's great appreciation. I think there's still more data trickling, 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 three dimensions. We're seeing a lot of other parameters kind of adding up together to a very promising picture. And obviously, there's excitement. We'll know formally where we are toward the end of the year. But the data looks very good. And I think there's, you know, we're excited to kind of have the discussion with them, potentially have them to continue to support. I mean, to date, they've put in almost $40 million non-dilutive.

the program so quite dramatic support and we've never gotten to this point without them no that's great a great feedback thanks for that and then my last question is around all four and I guess I wanted to maybe get a little more color from you as well as those on the call with regard to you know the utility and you know 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?

Right. So that's a great question. I think we have seen in the past, you know, drugs that were either approved or conditionally approved or accelerated approval based on microbiology. But 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 we're kind of improving in clinical and breathing capacity of these patients as well as patient-reported outcome. 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 worse outcome, worse prognosis, worse survival. Actually, there was just a recent paper that just came out. I was reading this morning exactly how many patients 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 life. So I think we're trying to sort of get alignment, get as much as we can on, you know, historically, what do patients do? Look at registries in the U.S. and Europe and kind of gather all the information, try to build a case and see whether there's a path to somehow hasten and sort of, you know, get a shorter pull path. Again, everything depends on discussion with a 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 this path going forward.

Got it. Appreciate all the feedback, Jonathan, and see you soon.

You bet. Excellent questions as always, so thank you.

Thank you. As a reminder, to ask a question, please press star 1-1. Our next question comes from Yeo Jin with Laylawn Company. Your line is open.

Good morning, and thanks for taking the questions, and congrats to get the 004 program to start and hopefully finish soon in first quarter next year. Just 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.

Sure. So, yeah, good morning and 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 therapeutics. So I think we are still in line with the timeline and think that the data is going to be ready in the first quarter.

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

Great question. So, you know, it is an area of a lot of interest. As I mentioned, right, you see papers coming out. I was 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, sort of tracking over a long period of time. Thirdly, 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. Again, right, not surprising. We know it's a very nasty bug. We also did a questionnaire of care territory 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 all together. So I think all of that data kind of feeds into that discussion. Again, this is an ongoing process and we're going to align it 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 NTFB in bronchactasis. And there, again, you see all the analogy, right? All the articles that kind of say, hey, the presence of the cure is going to lead to worse clinical outcomes, you know, 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, you know, what we've seen in the Phase 2a was that 14% of the patients got rid of the 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 two 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, you know, we're very excited about the combination of, you know, 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 the CF product and extend it even further to a market which is even greater.

Okay, great.

Maybe I'll just squeeze in one more.

In terms of 2.1.1, you were preparing for the registration study. Just curious, I mean, what a general framework of that study might look like? And was there any timeline you were prepared for have a discussion with the FDA?

Yeah, so we are interested in having that discussion, you know, 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 inspection resolution, which is supported by some of the data that we've seen, right? We're seeing the ELSO shrink, but we see all the other parameters kind of improving uh so that's exciting and i think that gives us like a broad uh framework of how to pursue and diabetic split osteo you kind of look at a bit of a longer time frame and then you want to look at you know the whole infection resolution which also includes like looking at the bone with mri and x-ray so there is a broad uh outline of what we need to do uh and again i think there is a guidance and thinking we'll 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 advisors that, including Benjamin Lipsky, that was on our KOL call, he's one of the people that actually was involved in writing the guidance, right? So we feel we're in good hands, but, you know, we've got to verify, have the interaction, and then sort of lay out a proper design.

Okay, great. That's very helpful. And again, congrats on kickoff. critical study and look forward to talking to you as well as seeing the data later on. Thank you, Gail. We appreciate it.

Thank you. I'm sure no further questions. I'd like to turn the call back over to Jonathan Solomon for any concluding remarks.

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'll enjoy the rest of the summer. Thank you again.

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