Q2 2025 BiomX Inc Earnings Call and Business Update

Speaker 2: Good morning and welcome to the BiomX Inc. 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 BiomX Inc. Please proceed.

Speaker #2: Good morning and welcome to the BiomX second quarter 2025 financial results and business and program update conference call. Currently all participants are in listen-only mode.

Speaker #2: 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 BiomX.

Speaker #2: Please proceed.

Marina Wolfson: Thank you. Welcome to the BiomX Inc. 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 in the Investors section of our website. As we begin, I would like to review the safe harbor provision. All statements on this call that are not factual historic statements may be deemed forward-looking statements.

Speaker #3: 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.

Speaker #3: 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 AM Eastern Time today and can be found on our website, at biomx.com.

Speaker #3: Our weekly office call will also be available on the investors section of our website. As we begin, I'd like to review the Safe Harbor provision.

Speaker #3: All statements on this call that are not factual historical 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, be it 704 and be it 211; and the potential markets and partnering opportunities for our product candidates.

Marina Wolfson: For instance, we are 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, BX-004 and BX-211, 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 #3: 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.

Speaker #3: Accepted, 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 the forward-looking statements, is outlined in today's press release.

Marina Wolfson: 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 BiomX Inc. Chief Executive Officer Jonathan Solomon, to whom I will now turn over the call.

Speaker #3: Which, as noted earlier, is on our website. Joining me on the call this morning is BiomX Chief Executive Officer, Jonathan Solomon, to whom I will now turn over the call.

Jonathan Solomon: Thank you, Marina. Thank you all for joining BiomX Inc.'s second quarter 2025 update today. The second quarter of 2025 has been a productive period for BiomX Inc. 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 1B/2A study in Nature Communication in July, providing further validation of our phage therapy platform. Let me start by reviewing the recent progress across our clinical pipeline.

Speaker #4: Thank you, Marina, and thank you all for joining BiomX's second quarter 2025 update today. This 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.

Speaker #4: During the quarter, we made important progress on both our BX704 and BX211 programs, and we 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 BX704 for cystic fibrosis patients, an important step as we advance toward top-line results expected in the first quarter of 2026.

Speaker #4: We also published additional data from our BX704 Phase 1B2A study in Nature Communications in July, providing further validation of our phage therapy platform. Let me start by reviewing recent progress across our clinical pipeline.

Jonathan Solomon: We launched into the second quarter with a virtual key opinion leader event to discuss the positive top-line Phase 2 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 significance of its 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 of ulcer size with a p-value of 0.046 at week 12 and 0.052 at week 13. We saw separation from placebos starting at week 7 with a difference greater than 40% by week 10.

Speaker #4: We launched into the second quarter with a virtual key opinion leader event to discuss the positive top-line phase 2 results for BX211 that were reported in March 2025.

Speaker #4: The event received resounding endorsement from key opinion leaders, physicians, and industry experts, highlighting the enthusiasm surrounding the strength of the data and the significance of its potential in addressing the needs of patients living with diabetic foot osteomyelitis (DFO).

Speaker #4: To recap, those March results demonstrated that BX211 was safe and well tolerated, and produced a 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.

Speaker #4: We saw a 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 depth at week 13 in patients with ulcer depth 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.

Jonathan Solomon: 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 2 results, we are now engaged in continued discussion with the U.S. Defense Health Agency, a key financier and supporter driving the development of the BX-211 program.

Speaker #4: As background on the significance of these programs, DFO is an extremely challenging indication with substantial unmet patient need, each year there are approximately 160,000 lower limb amputations and diabetic patients in the US alone, with 85% estimated to be caused either by DFO or diabetic foot infections.

Speaker #4: No therapeutics have been approved in the United States specifically for the treatment of DFO in over 20 years. Following the positive phase 2 results, we are now engaged in continued discussion with the US Defense Health Agency, a key finance firm supporter driving the development of BX211 program.

Jonathan Solomon: In parallel, we are currently planning for the BX-211 registrational study, pending discussion and feedback from the FDA. The second quarter also marked continuous advancement for our Phase 2B trial of BX-004, 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 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 1B/2A data, in which 14.3% of patients cleared infections completely after 10 days of treatment.

Speaker #4: And in parallel, we are currently planning for BX211 registration study pending discussion and feedback from the FDA. The second quarter also marked with continuous advancement for our phase 2B trial of BX704, which included the successful initiation of patient dosing in this phase 2B trial.

Speaker #4: 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.

Speaker #4: 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.

Jonathan Solomon: The design of the Phase 2B trial of BX-004 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 BX-004 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 our Phase 1B/2A trial, showcasing previously unreported antimicrobial efficacy data that demonstrated BX-004 achieving a substantially greater improvement of approximately 500-fold. That is a 2.7 log reduction in bacterial reduction compared to placebo in CF patients.

Speaker #4: The design of the phase 2B trial of BX704 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.

Speaker #4: Patients in the trial will be randomized at a 2:1 ratio to receive either BX704 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.

Speaker #4: In July, we published in a highly acclaimed Nature Communication publication. The paper included new findings from our phase 1B2A trial, showcasing previously unreported antimicrobial efficacy data that demonstrated BX704 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.

Jonathan Solomon: Importantly, the data also highlights no bacterial resistance to BX-004 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 a phage platform and methodology from the broader scientific community. We continue to press forward with the execution of the BX-004 trial. In parallel, we expect to receive feedback from the U.S. FDA regarding the potential investigation and use of real-world evidence linking bacterial reduction to clinical outcomes during the second half of 2025, branched closer to addressing the urgent unmet need of patients with Pseudomonas aeruginosa CF infections sooner.

Speaker #4: Importantly, the data also highlights that no bacterial resistance to BX704 emerged during the trial. The article also details our innovative approach to large-scale data analysis in order to optimize bacterial phage cocktails.

Speaker #4: We believe that this publication is, in one of the highly prestigious scientific journals, represents an important validation for our phage platform and methodology from broader scientific community.

Speaker #4: We continue to press forward with the execution of the BX704 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 bacterial reduction to clinical outcomes.

Speaker #4: During the second half of 2025, we're 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 achievements in July, reinforces our approach and gives us strong momentum as we advance towards our next milestones.

Jonathan Solomon: 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 would like to now pass you on to Marina Wolfson to review our second quarter 2025 financial results.

Speaker #4: 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 BiomX Inc.'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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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.

Marina Wolfson: 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 BX-004. 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.

Speaker #3: 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.

Speaker #3: This was partially offset by higher expenses from initiating the Phase 2B clinical trial for CF product candidate BX704. 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.

Speaker #3: 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 dollars for the second quarter of 2025, compared to income of 4.5 million dollars for the second quarter of 2024.

Speaker #3: 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 30, 2025, was $14.8 million, compared to $22.6 million for the same period in 2024.

Marina Wolfson: Net cash used in operating activities for the six months ended June 30, 2025, was $14.8 million compared to $22.6 million for the same period in 2024. I will now return the call to Jonathan for his closing remarks.

Speaker #3: I'll now return the call to Jonathan for his closing remarks.

Jonathan Solomon: Thanks, Marina. The second quarter of 2025 was a productive period for BiomX Inc. 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 BX-004 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 BX-004 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.

Speaker #4: Thanks, Marina. The second quarter of 2025 was a productive period for BiomX as we advanced our clinical programs and built momentum for upcoming milestones.

Speaker #4: Since the end of the quarter, we have achieved important milestones, including the successful initiation of our BX704 phase 2B trial and the publication of our data in Nature Communications.

Speaker #4: 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 and discussion with the US Defense Health Agency, and BX704 phase 2B top-line results expected in the first quarter of 2026, we continue to advance our potentially life-changing therapeutics.

Speaker #4: 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.

Jonathan Solomon: With that, we'd like to open to questions.

Speaker 2: Thank you. If you'd like to ask a question, please press star-11. If your question has been answered and you'd like to remove yourself from the queue, please press star-11 again. Our first question comes from Joe Panguiness with HC Wainwright. Your line is open.

Speaker #2: Thank you. If you'd like to ask a question, please press *11. If your question has been answered and you'd like to remove yourself from the queue, please press *11 again.

Speaker #2: Our first question comes from Joe Panganis with HC Wainwright. Your line is open.

Joe Panguiness: 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 bacteria phage. For the BX004 study, you mentioned significant interest in the study. You have the Phase 2 data for BX211. 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?

Speaker #5: 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 bacteria phage.

Speaker #5: So, for the OO4 study you mentioned, there is significant interest in the study. You have the Phase 2 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 in wanting to be in the studies?

Jonathan Solomon: Joe, good morning. I look forward to meeting you face to face in New York pretty soon in the conference. You are hitting the nail on the head. I think we have seen, if in the past, you remember all our conversation, right? The previous CF study took a while to recruit. Now sites are excited, patients are excited, physicians are excited. It does seem very different. Again, I think it is our prior data. I think it is the data that others have generated. I think there is excitement around efficacy. There is a greater level of comfort around safety, which we knew was a strong point of phage to begin with. Really, sites and patients are calling us all the time on top of the standard compassionate use request to participate in the study. It is a very exciting time in the field.

Speaker #4: So, Joe, good morning. I look forward to meeting you face-to-face in New York pretty soon at the conference. You're hitting the nail on the head.

Speaker #4: I think we've seen it in the past. Do you remember all our conversations? Right? The previous CF studies took a while to recruit. Now, sites are excited, patients are excited, physicians are excited.

Speaker #4: So it does seem very different. And again, I think it's our prior data; I think it's the 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 phage to begin with.

Speaker #4: And really, sites are just, you know, and patients are calling us all the time on top of like the standard compassion use requests. To participate in the study.

Speaker #4: 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 acclaimed journals.

Jonathan Solomon: I think there is a lot going on, right? I add to it publications in very highly acclaimed journals, the fact that people are talking about it in the communities and the patient communities. That also bleeds into strategic interest, right? You remember all our conversations kind of waiting for this inflection point to come. I think we are there, right? You never really know unless you have historical perspective. But it does feel very different, right? Both from patients, caretakers, and even strategics that are now saying, wow, there is actually data out there. There are a few Phase 2 randomized, placebo-controlled studies that are showing efficacy and all the kind of data sets that we wanted to see. I think it is not an approved drug yet, but we are definitely heading in the right direction. Let us hope that momentum just keeps on going.

Speaker #4: The fact that people are talking about it in the communities and the 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.

Speaker #4: 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 2s randomized placebo-controlled studies, they're showing efficacy and, you know, all the kind of data sets that we wanted to see.

Speaker #4: 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.

Joe Panguiness: No, that's great to hear. Looking forward to seeing more out of the space. With regard to BX-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 you are looking to link that up with your ongoing discussions with the Defense Health Agency.

Speaker #5: 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, 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?

Jonathan Solomon: I think it is really the data set that we have seen is really exciting. It is one of those data sets that, as a friend says, you just need to show one graph, and the data is very significant. There is a 40% reduction, which is statistically significant in a very tough indication. I think the path forward opens up. Obviously, diabetic foot osteomyelitis is kind of a subset within diabetic foot infection. I think there is the possibility to kind of advance in both paths. That is what we are looking into. There is ongoing, you know, prepping for the discussion with the regulatory agencies. I think that path, in some ways, is pretty laid out. There is a specific guidance on diabetic foot infections and endpoints around infection resolution. Of course, we want to validate and have that discussion with the agency.

Speaker #4: So So obviously I think it's a 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?

Speaker #4: And Dave's very significant. There's a 40% reduction, which is statistically significant in the very tough indication, right? I think the path forward opens up. Obviously, diabetic foot osteo is kind of a subset within diabetic foot infection.

Speaker #4: I think there's a possibility to kind of advance in both paths. And that's we're looking into and there's ongoing, you know, prepping for the discussion with the regulatory agencies.

Speaker #4: So I think that path, in some ways, is pretty laid out, right? There's a specific guidance on diabetic foot infections and endpoints around infection resolution.

Speaker #4: 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, to kind of go for a registrational study.

Jonathan Solomon: I think we know how the next study potentially can look like to kind of go for a registrational study. To your point, I think the Defense Health Agency has been great in understanding that they can support. They do not want to support indications where it is 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. That is why they are supporting the diabetic foot. They want to see a registrational study. They want to see a drug approved. Then they can kind of use it in combat wounds. There is great appreciation. I think there is still more data trickling, unfortunately, from the Ukraine war showing a lot of antibiotic resistance. When you look at the data that we have in our study, we are looking at soft tissue.

Speaker #4: 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 you're solely for military use, right?

Speaker #4: They understand that the real path to success is to support programs that have a, you know, a use in the private market or the standard market.

Speaker #4: 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.

Speaker #4: 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?

Jonathan Solomon: We looked at the ulcers. We saw the ulcers kind of shrink on all three dimensions. We are seeing a lot of other parameters kind of adding up together to a very promising picture. Obviously, there is excitement. We will know formally where we are toward the end of the year. The data looks very good. I think we are excited to kind of have the discussion with them and potentially have them to continue to support. To date, they put in almost $40 million non-dilutive in the program, so quite dramatic support. We would never have got to this point without them.

Speaker #4: 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.

Speaker #4: 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 and potentially have them continue to support.

Speaker #4: I mean, to date, they've put in almost $40 million non-dilutive in the program. So, quite dramatic support, and we've never gotten to this point without them.

Joe Panguiness: No, that is great. Great feedback. Thanks for that. My last question is around BX004. 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 are looking to provide them. What is the general use for that and the benefits for the program?

Speaker #5: No, that's great. Great feedback. Thanks for that. And then my last question is around OO4, 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.

Speaker #5: Like, what is the general use for that and the benefits for the program?

Jonathan Solomon: 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. 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. I actually, there was just a recent paper that just came out.

Speaker #4: Right, so that's a great question. I think we have seen in the past, you know, drugs that were either approved, conditionally approved, or received accelerated approval based on microbiology, right?

Speaker #4: 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, right?

Speaker #4: 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.

Speaker #4: 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.

Speaker #4: I actually, there was just a recent paper that just came out, I was just reading this morning, exactly on even patients that are taking the modulators, we're still seeing persistent infection of Pseudomonas and, you know, this is a nasty bug, right?

Jonathan Solomon: I was just reading this morning exactly on even patients that are taking the modulators. We're still seeing persistent infection of Pseudomonas. And you know, this is a nasty bug. 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, 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 approval 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 this path going forward.

Speaker #4: 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 on, you know, historically what do patients do, look at registries in the U.S. and Europe, and kind of gather all the information.

Speaker #4: Try to build the case and see whether there's a path to somehow hasten and sort of, you know, get a shorter approval path. Again, everything depends on discussion with the regulatory agency.

Speaker #4: It's still early in the process, but we're looking for some alignment, you know, our thinking whether it makes sense and whether we pursue this path going forward.

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

Speaker #5: Got it. Appreciate all the feedback, Jonathan, and see you soon.

Jonathan Solomon: You bet. Excellent questions as always, so thank you.

Speaker #4: You bet. Excellent questions as always, so thank you.

Speaker 2: Thank you. As a reminder, to ask a question, please press star-11. Our next question comes from Yale Jen with Leilong Company. Your line is open.

Speaker #2: Thank you. As a reminder, to ask a question, please press *11. Our next question comes from Yale Jin with Leylon Company. Your line is open.

Yale Jen: Good morning, and thanks for taking the questions and congrats to get the BX004 program to start and hopefully finish soon in Q1 of next year. Just follow up on the BX004. I understand that the study just started in July, but any updates or preliminary look in terms of the enrollment status? Then I have some follow-ups as well.

Speaker #6: Good morning, and thanks for taking the questions. Congratulations on getting the 004 program started, and hopefully finished soon in the first quarter of next year.

Speaker #6: Just following up on the 004. I understand that the study just started in July, but are there any updates or a preliminary look in terms of the enrollment status?

Speaker #6: And then I have some follow-ups as well.

Jonathan Solomon: 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 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.

Speaker #4: 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?

Speaker #4: 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're we are still in line with the timeline and think that the data is going to be ready in the first quarter.

Yale 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, you know, generated some documents that once the FDA would like to have a chance of chatting with you, and you already have that sort of material ready? Also, is there any date or time that's been set up for that discussion?

Speaker #6: Okay, great. Maybe another 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?

Speaker #6: So the material ready, and also with some sort of what does any phase or time has been set up for that discussion?

Jonathan Solomon: Great question. So, you know, it is an area of a lot of interest. As I mentioned, you see papers coming out. I was just reading this morning a paper on this. On the company end, what we are doing is threefold. We had a panel of key opinion leaders convened on this and had a discussion and provided the recommendation, which is part of our discussion with the regulatory agencies. There is work that we are doing on real-world evidence, meaning that we are actively tapping into registries and gathering all the information, tracking over a long period of time. Thirdly, a literature analysis, which obviously there is a lot of support that we have discussed in the past around this indication. So I think that is really interesting to see the presence of it appear through the years. Again, not surprising.

Speaker #4: Great question. So, you know, it is an area of a lot of interest. As I mentioned, right, you see papers coming out and just reading this morning a paper on this.

Speaker #4: 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.

Speaker #4: There is work that we're doing on real-world evidence, meaning that we're we are actively tapping into registries and gathering all the information. Right? So we're tracking over a long period of time.

Speaker #4: 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 the fear through the years.

Speaker #4: And again, right, not surprising, we know it's a very nasty bug. We also did a questionnaire of caretakers across the country. And again, it's very clear, right?

Jonathan Solomon: We know it is a very nasty bug. We also did a questionnaire of caretakers across the country. Again, it is very clear. There is a reason why all these patients are being treated with antibiotics and they are trying to get rid of the infections altogether. So I think all of that data feeds into that discussion. Again, this is an ongoing process and we are going to align on this. I will also say I think it is really interesting as we are having the discussion today. Yesterday, for the first time, a drug was approved in NCFP in bronchiectasis. There again, you see all the analogy, all the articles that say, hey, the presence of the cure is going to lead to worse clinical outcomes, reduce survival, increase mortality. All of that data is out there.

Speaker #4: There is a reason why all these patients are being treated with antibiotics and they're trying to kind of get rid of the infections altogether.

Speaker #4: 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 on this.

Speaker #4: 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 NCFP, in bronchiectasis.

Speaker #4: 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.

Speaker #4: You know, we do 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.

Jonathan Solomon: So there is a lot of analogy and I think a lot of excitement as we think about all these indications. Again, there is a lot of rationale why we do not want these patients to have these bacteria and how detrimental it is. What we have seen in the Phase 2A was that 14% of the patients got rid of the infection altogether. That is really exciting. So I think if we can replicate this kind of data, and hopefully improve it because that was only in 10 days and in this study is two months, then we are looking at quite an exciting value proposition. Knock on wood that everything replicates and the interactions go the right way. But you know we are very excited about the combination of the real-world evidence, hopefully the clinical outcome, and the data that we have seen.

Speaker #4: 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.

Speaker #4: 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 in this study is two months.

Speaker #4: 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 the real-world evidence, hopefully the clinical outcome, and the data that we've seen.

Jonathan Solomon: As we have charted many times, the possibility to take the CF product and even extend it even further to a market which is even greater.

Speaker #4: And as we try it many times, right, the possibility to take the CF product and even extend it even further to a market which is even greater.

Yale Jen: Okay, great. And maybe I am just squeezing one more. In terms of BX211, you were preparing for the registrational study. Just curious, what a general framework of that study might look like? And was there any timeline that you were prepared for to have a discussion with the FDA?

Speaker #6: Okay, great. Maybe I'll just squeeze in one more. In terms of 211 you were preparing for the registration study, just curious, I mean, what a general framework of that study might look like?

Speaker #6: And was there any timeline you were prepared for having a discussion with the FDA?

Jonathan Solomon: Yeah, so we are interested in having that discussion in the second half, so by the end of this year. I think we are gearing up to it. You do know, for example, when you are looking at, again, right, you could kind of split and look at the DFI in general, whether it is guidance and there is a predefined endpoint, which is an infection resolution, which is supported by some of the data that we have seen, right? We are seeing the ulcers shrink, but we see all the other parameters kind of improving. That is exciting. I think that gives us like a broad framework of how to pursue. Diabetic foot osteo, you kind of look at a bit of a longer timeframe. Then you want to look at the whole infection resolution, which also includes like looking at the bone with MRI and X-ray.

Speaker #4: 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.

Speaker #4: You do know, for example, when you're looking at, again, right, you could kind of split and look at the DFI in general, whether it's guidance and there's a predefined endpoint, which is the infection resolution.

Speaker #4: 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. I think that gives us a broad framework of how to pursue.

Speaker #4: And diabetic foot osteomyelitis, you want to look at a bit of a longer timeframe, and then you want to look at, you know, the whole infection resolution, which also includes looking at the bone with MRI and X-ray.

Jonathan Solomon: There is a broad outline of what we need to do. Again, I think there is a guidance and thinking we will talk to the FDA and sort of try to solidify, but there is a very clear guidance document on this, right? That is very helpful. We are basically looking to kind of ratify our understanding. Again, some of the advisors, including Benjamin Lipsky, that was on a KOL call, he is one of the people that actually was involved in writing the guidance, right? We feel we are in good hands, but you know, I got to verify, have the interaction, and then sort of lay out a proper design.

Speaker #4: 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?

Speaker #4: 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?

Speaker #4: So we feel we're in good hands. But, you know, it got to verify how the interaction and then sort of lay out a proper design.

Yale Jen: Okay, great. That's very helpful. Again, congrats on kicking off the critical study and look forward to talking to you as well as seeing the data later on.

Speaker #6: Okay, great. That's very helpful, and again, congrats on the kickoff. I look forward to talking to you, as well as seeing the data later on.

Jonathan Solomon: Thank you, Gail. We appreciate it.

Speaker #4: Thank you, Gail. We appreciate it.

Speaker 2: Thank you. I am sure no further questions. I would like to turn the call back over to Jonathan Solomon for any concluding remarks.

Speaker #2: Thank you. I'm throwing no further questions. I'd like to turn the call back over to Jonathan Solomon for any concluding remarks.

Jonathan Solomon: 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 questions hopefully highlighted. I hope you enjoy the rest of the summer. Thank you again.

Speaker #4: 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 questions sort of hopefully highlighted and I hope you enjoy the rest of the summer.

Speaker #4: Thank you again.

Speaker 2: Thank you for your participation. You may now disconnect. Everyone, have a great day.