Earnings Call Transcript - PHGE Q2 2025

Operator, Operator

Good morning, and welcome to the BiomX Second Quarter 2025 Financial Results and Business and Program Update Conference Call. 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, CFO

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, CEO

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, bringing 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, CFO

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, CEO

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 discussions 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.

Operator, Operator

Our first question comes from Joe Pantginis with H.C. Wainwright.

Joseph Pantginis, Analyst

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, CEO

Joe, I'm looking forward to meeting you in New York at the conference soon. You're absolutely right. We've seen a notable change from previous CF studies, which took longer to recruit participants. Now, sites, patients, and physicians are all excited. This feels quite different. Our previous data, along with data generated by others, has sparked excitement about efficacy and increased comfort around safety, which has always been a strong point for us. Sites and patients are frequently reaching out to us, on top of regular compassionate use requests to join the study. It's an exhilarating time in the field with significant activity. Additionally, we have publications in highly regarded journals, increasing discussions in both professional and patient communities, which contributes to strategic interest. We've been anticipating this turning point, and it seems like we've arrived. While we can't know for sure without historical perspective, everything feels markedly different from the perspectives of patients, caretakers, and even strategics who are now aware of the data being presented. There are several Phase II randomized placebo-controlled studies demonstrating efficacy and the data we've been looking for. Although the drug isn't approved yet, we are definitely moving in the right direction, and we can hope that the momentum continues.

Joseph Pantginis, Analyst

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, CEO

The data we have is truly exciting. It’s one of those data sets that speaks for itself with just one graph, which shows a 40% statistically significant reduction in a challenging indication. The potential to advance in both diabetic foot osteo and diabetic foot infection is something we are actively exploring, and we are preparing for discussions with regulatory agencies. The path ahead seems clear, as there is specific guidance on diabetic foot infections and endpoints focused on infection resolution. We aim to validate this through discussions with the agencies. We also have an idea of how the next study could be structured for a registrational study. Furthermore, the Department of Justice recognizes the importance of backing programs with applications in the private market versus just military use. This is why they are supporting diabetic foot initiatives and expect to see a registrational study leading to drug approval for combat wounds. We appreciate their support, which has amounted to nearly $40 million in non-dilutive funding so far. We are gathering more data, particularly relating to antibiotic resistance observed in the context of the Ukraine war, and our study shows promising results, particularly in the reduction of ulcer dimensions across various parameters. There’s significant excitement about where we stand, and we anticipate sharing more formal updates by the end of the year.

Joseph Pantginis, Analyst

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, CEO

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 worse outcome, worse prognosis, and worse survival. I actually saw a recent paper that just came out 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 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 route. 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

Our next question comes from Yale Jen with Laidlaw & Company.

I-Eh Jen, Analyst

Congrats to get the 004 program to start and, hopefully, finish in the 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, CEO

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 timeline and think that the data is going to be ready in the first quarter.

I-Eh Jen, Analyst

Okay. Great. I would like to follow up on Joe's question. Regarding the real-world data you plan to discuss with the FDA, have you completed any work or generated any documents that would be ready for a discussion if the FDA is interested? Also, have any dates or times been set for that conversation?

Jonathan Eitan Solomon, CEO

Great question. This is an area of significant interest. As I mentioned, there are new papers emerging, and I was just reading one this morning. On our end, we are taking a three-pronged approach. We convened a panel of key opinion leaders to discuss and provide recommendations, which is an important part of our conversations with regulatory agencies. Additionally, we are working on real-world evidence by actively engaging with registries and collecting information over an extended period. We are also conducting a literature analysis, which shows considerable support for this indication. It's fascinating to witness the consistent presence of this issue over time, and it's not unexpected given how challenging this pathogen is. We also carried out a survey across our care territories nationwide, which clearly illustrates why so many patients are being treated with antibiotics in an effort to eliminate infections. This data all contributes to the ongoing discussion. It's worth noting that just yesterday a drug was approved for NCFB in bronchiectasis, highlighting the fact that the presence of bacteria can lead to worse clinical outcomes, reduced survival, and increased mortality. A lot of relevant data is available. There’s considerable interest in exploring these indications further. The rationale for wanting to eliminate these bacteria is compelling. In our Phase IIa trial, we found that 14% of patients completely cleared the infection, which is very promising. If we can replicate this data and potentially improve upon it—given that this study lasts two months compared to the previous ten-day study—we could have an exciting value proposition on our hands, assuming all goes well. We are enthusiastic about combining the real-world evidence with the clinical outcomes and the data we've observed. We've approached this in various ways, and there is potential to expand the product further into a much larger market.

I-Eh Jen, Analyst

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 timeline that you will prepare for have a discussion with the FDA?

Jonathan Eitan Solomon, CEO

We are interested in having that discussion in the second half of the year. We're preparing for it. For instance, when considering the DFI, there is guidance and a defined endpoint related to infection resolution, which is supported by data we've observed. We're seeing the ulcer shrink, and other parameters are also improving. This is promising and provides a broad framework for our approach. In diabetic foot osteo, we need to take a longer timeframe and also assess the infection resolution by examining the bone through MRI and X-ray. There is a clear outline of what is required. We will communicate with the FDA to confirm our understanding, and there is an established guidance document on this matter which is very helpful. We aim to validate our approach, and we have advisers, including Benjamin Lipsky, who contributed to the guidance. We believe we are well-prepared, but we still need to confirm our plans and establish a proper study design.

I-Eh Jen, Analyst

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, CEO

Thank you, Yale. We appreciate it.

Operator, 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, CEO

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, Operator

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