BiomX Q2 2025 Earnings Call Transcript

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Provided by Quartr
August 13, 2025

Key Takeaways

  • Positive Sentiment: BioMix initiated patient dosing in BX004 Phase 2b trial for cystic fibrosis, with top‐line results expected in 2026 and a July Nature Communications publication showing a ~2.7-log bacterial reduction and no observed resistance.
  • Positive Sentiment: Positive Phase 2 results for BX211 in diabetic foot osteomyelitis demonstrated statistically significant ulcer area and bone involvement improvements, prompting planning for a registrational study and continued Defense Health Agency support.
  • Neutral Sentiment: Cash and restricted cash totaled $15.2 million as of June 30 2025, representing runway into 2026 despite a second‐quarter net loss of $6 million, driven primarily by warrant fair‐value changes.
  • Positive Sentiment: Research and development expenses decreased to $5.0 million and general and administrative expenses to $2.4 million, reflecting workforce reductions, asset impairments and grant funding, partially offset by Phase 2b trial start‐up costs.
AI Generated. May Contain Errors.
Earnings Conference Call
BiomX Q2 2025
00:00 / 00:00

There are 5 speakers on the call.

Operator

Good morning and welcome to the BioMix Second Quarter twenty twenty five Financial Results and Business and Program Update Conference Call. Currently, all participants are in a 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.

Operator

Please proceed.

Speaker 1

Thank you, and welcome to the BioMix conference call to review the company's second quarter twenty twenty five 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 06:30 a. 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.

Speaker 1

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 equipment, 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, passing 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.

Speaker 1

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 BioNTech's Chief Executive Officer, Jonathan Salmon, to whom I will now turn over the call.

Speaker 2

Thank you, Marina. And thank you all for joining Bionics' second quarter twenty twenty five update today. The 2025 has been a productive period for Bionics as we continue to advance our clinical programs and build scientific validation for our phase 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.

Speaker 2

An important step as we advance toward top line results expected in the 2026. We also published additional data from our BX004 phase 1B2A study in nature communication in July, providing further validation of our phase 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 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.

Speaker 2

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 twelve 0.052 at week thirteen. We saw separation from placebo starting at week seven with a difference greater than 40% by week ten. The results showed statistically significant improvement in both ulcer death at week thirteen 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 one hundred and sixty thousand lower limb amputations in diabetic patients in The US alone, with eighty five percent estimated to be caused either by DFO or diabetic foot infections.

Speaker 2

No therapeutics have been approved in The United States specifically for the treatment of DFO in over twenty years. Following the positive phase two results, we are now engaged in continued discussion with the US Defense Health Agency, a key finance 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 2b trial of BX004, which included the successful initiation of patient dosing in this phase 2b 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 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 a prior phase 1b2a data in which fourteen point three percent of patient cleared infections completely after ten days of treatment.

Speaker 2

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, multicenter study in approximately sixty cystic fibrosis patients with chronic Pseudomonas aeruginosa infections. Patients in the trial will be randomized at a two to one 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 a highly acclaimed nature communication publication. The paper included new findings from phase one B2A trial showcasing previously unreported antimicrobial efficacy data that demonstrated BX004 achieving a substantially greater improvement of approximately 500 fold.

Speaker 2

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 journal 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 2025, bringing us closer to addressing the urgent unmet need of patients with pseudomonas aeruginosa CF infections sooner.

Speaker 2

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 twenty twenty five financial results.

Speaker 1

Thank you, Jonathan. As a reminder, the financial information for the company's second quarter twenty twenty five 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 06/30/2025, were $15,200,000 compared to $18,000,000 as of 12/31/2024. The decrease was primarily due to net cash used in operating activities.

Speaker 1

We estimate that our cash, cash equivalents and restricted cash are sufficient to fund our operations into the 2026. Research and development expenses net were 5,000,000 for the 2025, compared to $6,900,000 for the 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 $2,400,000 for the 2025, compared to $2,800,000 for the 2024.

Speaker 1

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 $6,000,000 for the second quarter of twenty twenty five, compared to income of $4,500,000 for the 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 06/30/2025 was $14,800,000 compared to $22,600,000 for the same period in 2024. I'll now return the call to Jonathan for his closing remarks.

Speaker 2

Thanks, Marina. The second quarter of twenty twenty five 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 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 phase therapy platform from the global research community. With multiple value creating catalysts ahead, including FDA feedback on a real world evidence approach in the 2025, ongoing collaboration discussion with the US Defense Health Agency, and BX004 phase 2B top line results expected in the 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.

Speaker 2

Thanks again to all who joined the call this morning. And with that, we'd like to open to questions.

Operator

Thank you. Our first question comes from Joe Pantginis with H. C. Wainwright. Your line is open.

Speaker 3

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 four study, you mentioned significant interest in the study. You have the phase two data for 02/11.

Speaker 3

So I was just curious, based on the positive clinical data that you've delivered as well as others in space, have you seen a relative inflection with regard to site and physician interest with regard to wanting to be in the studies?

Speaker 2

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, if 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. Again, think it's our prior data, I think it's a data that others have generated.

Speaker 2

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. Really sites are just, and patients are calling us all the time on top of 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, add to it, publications in very highly acclaimed journals, the fact that people are talking about it in the communities, in the patient communities, and that also bleeds into strategic interests. You remember all our conversations kinda waiting for this inflection point to come.

Speaker 2

I think we're there, you never really know unless you have a historical perspective, but it does feel very different. Both from patients, caretakers, and even strategics that are now saying, there's actually data out there, there's a few phase twos randomized, placebo controlled studies, they're 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, so that momentum just keeps on going.

Speaker 3

No, that's great to hear and looking forward to seeing more out of the space. So, with regard to two eleven, 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?

Speaker 2

So obviously, think it's really, the data set that we've seen is really exciting. It's one of those data sets that, as a friend says, you just need to share one graph. The data is very significant, there's a forty percent reduction, which statistically significant in a very tough indication. I think the path forward opens up, obviously diabetic foot osteo kind of subset within diabetic foot infection. I think there's a possibility to kind of advance in both paths.

Speaker 2

And that's a bit 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. There's a specific guidance on diabetic foot infections and endpoints around infection resolution. But of course we wanna validate and have that discussion with the agency. I think we know how does the next study potentially can look like to go for a registrational study.

Speaker 2

To your point, and I think the DHA has been great in understanding that they don't wanna 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 wanna see a registrational study, they wanna see a drug approved, and then they can kinda 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, we're looking at soft tissue, we looked at the ulcers, we saw the ulcers kind of shrink on all three dimensions, we're seeing a lot of other parameters kinda 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, you know, we're excited to kinda have the discussion with them, potentially have them to complete the support.

Speaker 2

I mean, to date, they put in almost $40,000,000 non dilutive in the program. So quite dramatic support and we've never gotten to this point without them.

Speaker 3

No, that's great feedback, thanks for that. And then my last question is around 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 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?

Speaker 2

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. 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 kinda 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.

Speaker 2

We have seen cases of approval on microbiology, which obviously 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, worse prognosis, worse survival. There was just a recent paper that just came out, I was reading this morning, on even patients that are taking demodulators, we're still seeing persistent infection of pseudomonas, and this is a nasty bug, It's not a good thing to have this thing in the line. So I think we're trying to sort of get alignment, get as much information as we can historically, what do patients do, look at registries in The US and Europe and kinda gather all the information, try to build the case and see whether there's a path to somehow hasten and sort of get a shorter approval path. Again, everything depends on discussion with the regulatory agency.

Speaker 2

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.

Speaker 3

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

Speaker 2

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

Operator

Thank you. Our next question comes from Yale Jen with Laidlaw and Company. Your line is open.

Speaker 4

Good morning, and thanks for taking the questions, and congrats to get the four program to start and, hopefully finish in first quarter next year. Just follow-up on of four. I understand that the 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.

Speaker 2

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

Speaker 4

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

Speaker 2

Great question. So, you know, 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.

Speaker 2

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. So 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 interesting to see the presence of the peer through the years. Again, not surprising, we know it's a very nasty bug.

Speaker 2

We also did a questionnaire of care carriers across the country. Again, it's very clear. There is a reason why all these patients are being treated with antibiotics and they're trying to get rid of infections altogether. I think all of that data feeds into that discussion. Again, this is an ongoing process and we're gonna alignment on this.

Speaker 2

I will also say, I think it's really interesting, as we're having the discussion today, yesterday for the first time a drug was approved in NCFB in bronchactasis. And there again, see all the analogy. All the articles that say, hey, the presence of the cure is gonna lead to worse clinical outcomes, reduce survival, increase mortality, and all that data is out there. 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. What we've seen in the phase 2A was that fourteen percent of the patients got rid of infection altogether, that's really exciting.

Speaker 2

So I think if we can replicate this kind of data, hopefully improve it, because that was only in ten days, and this study is two months, then we're looking at quite an exciting value proposition. 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, the data that we've seen. And as we've tried it many times, right, the possibility to take the CF product and even extend it even further to a market which is even greater.

Speaker 4

Okay, great. Maybe I'll just squeeze in one more. Sure. In terms of Tube one one, 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 will prepare for have a discussion with the FDA?

Speaker 2

Yeah. So we are 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, you could split and look at the DFI in general, where there's guidance and there's a predefined endpoint, which is infection resolution, which is supported by some of the data that we've seen. We're seeing the ulcer shrink, but we see all the other parameters kinda improving.

Speaker 2

So that's exciting, I think that gives us a broad framework of how to pursue in diabetics. But osteo, you kinda look at a bit of a longer timeframe, then you wanna look at the whole infection resolution, which also includes looking 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, I'm thinking we'll talk to the FDA and sort of try to solidify, but there's a very clear guidance document on this, so that's very helpful, 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, is one of the people that actually was involved in writing the guidance. So we feel we're in good hands, but you know, we gotta verify, have the interaction, and then sort of lay out a proper design.

Speaker 4

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

Speaker 2

Thank you, Gail. We appreciate it.

Operator

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

Speaker 2

So, 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.

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