BiomX - Earnings Call - Q4 2024 & Study Result

Executive Summary

• BiomX reported Q4 and full-year 2024 results with no product revenue disclosed, higher R&D and G&A spend tied to BX004 and BX211, and a year-end cash and restricted cash balance of $18.0M; subsequent February 2025 financings added $12M gross proceeds, extending runway into Q1 2026.
• Q4 2024 EPS was -$1.15 vs consensus -$0.30 (2 ests), indicating a miss amid continued clinical investment; revenue consensus was $0.0 (2 ests) and no Q4 revenue was reported (pre-revenue biotech) (values from S&P Global)*.
• Clinical execution remains the core catalyst: management flagged BX211 Phase 2 topline by end of March 2025 in the Q4 materials, then announced positive, statistically significant outcomes on March 31; a Phase 2/3 path is being planned pending FDA feedback.
• BX004 Phase 2b remains on track for topline in Q1 2026 after Q4 2024 manufacturing scale-up delays were resolved; regulatory discussions are expected in H2 2025.

What Went Well and What Went Wrong

• What Went Well

  • Positive BX211 Phase 2 topline demonstrated statistical significance in ulcer size reduction (PAR) at week 12 (p=0.046) with >40% separation from placebo by week 10; also significant in ulcer depth and reduced ulcer area expansion, with favorable trends across other clinical parameters.
  • Management signaled Phase 2/3 planning for BX211, framing results as a “watershed moment for phage therapy” and one of the strongest demonstrations of phage efficacy in a chronic bacterial infection.
  • Liquidity improved with $12M February 2025 raises, supporting BX004 Phase 2b through topline and analyses to inform H2 2025 regulatory discussions; cash runway guided into Q1 2026.

• What Went Wrong

  • BX004 Phase 2b timeline slipped due to Q4 2024 manufacturing scale-up delays (10L to 50L), shifting topline from earlier guidance to Q1 2026 (from H1 2026 previously).
  • FY24 operating loss expanded ($44.5M) as R&D rose to $24.7M and G&A to $11.8M, reflecting program advancement and APT integration; impairments (goodwill $0.8M, IPR&D $3.2M, long-lived assets $4.0M) also weighed on operating results.
  • Q4 EPS missed consensus (limited coverage), reflecting continued opex and fair-value/non-cash items (warrant revaluation swings across 2024) (values from S&P Global)*.

Transcript

Operator (participant)

Greetings and welcome to today's BiomX Investor presentation. At this time, all participants are in listen-only mode. If anyone should require operator assistance, please press star zero on your telephone keypad. A question-and-answer session will follow the formal presentation. You may press star one to be placed into question queue at any time. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to your host, Marina Wolfson, Chief Financial Officer. Marina, please go ahead.

Marina Wolfson (CFO)

Thank you for joining us today to discuss the positive top-line results from our ongoing phase II trial evaluating BX211 for the treatment of Staphylococcus aureus infections in patients with diabetic foot osteomyelitis, or DFO. Earlier today, BiomX issued a press release detailing top-line results from the phase II study that became available just after 6:30 A.M. Eastern Time. In addition, the presentation slides used on this call can be found on our website at biomx.com. BiomX also issued a press release on 2024 fourth quarter and full year financials and program updates on March 25th. A replay of this call will be available on the investor section of our website. As we begin, I'd like to review the safe harbor provisions. 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, the design, recruitment, aim, expected timing, and interim and final results of our preclinical and clinical trials, the potential benefits and the potential safety and efficacy of our product candidate, BX004 and BX211, as well as the potential outcomes of discussions that we may have with the US Food and Drug Administration, or FDA, and foreign regulatory agencies in timing thereof. In addition, past and current preclinical and 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 Chief Executive Officer, Jonathan Solomon, to whom I will now turn over the call to discuss the positive DFO readout.

Jonathan Solomon (CEO)

Thank you, Marina, and good morning, everyone. To begin, I'd like to give a brief overview of BiomX's activities. BiomX is developing customized phage therapies to eradicate harmful bacteria and chronic diseases. Our two lead programs target the unmet needs of patients with cystic fibrosis and diabetic foot osteomyelitis with BX004 and BX211, respectively. Both programs have now successfully completed phase II trials, and today we'll take the time to focus on the readout of the phase II results of BX211, oriented to meet the need of patients with DFO associated with Staphylococcus aureus. We are fortunate to have great investors and partners on the path to making phage widely available and accessible, just to mention a few: Deerfield Management, the Antimicrobial Resistance Action Fund, the Cystic Fibrosis Foundation, the Defense Health Agency, or DHA, and many others. Next slide.

This morning, we announced positive top-line results from our phase II trial evaluating BX211, a phage treatment for Staphylococcus aureus infections in patients with DFO. The results are a watershed moment for phage therapy. BX211 demonstrates statistical significance across several key parameters for DFO treatment and showed positive trends across multiple additional clinical parameters, collectively presenting a strong, compelling, and comprehensive data set. We believe this data represents one of the strongest demonstrations to date of the therapeutic potential of phage therapy. Next slide. Diabetic foot infections, DFI, are infections of the soft tissue in patients with diabetes that begin as superficial ulcers and then deepen and extend into the subcutaneous layer. As these infections further penetrate and spread into the bone, these are then characterized as DFO. Staphylococcus aureus infections are the main contributor to morbidity and mortality of patients with DFI and DFO.

Current standard of care for these patients includes hospitalization and debridement of these wounds alongside antibiotic treatment. However, treatment success is limited, with 20% to 40% of these cases eventually resulting in patient limb amputations. Next slide. The numbers are astounding and show the extent of the substantial unmet need for patients. In the U.S., there are more than 38 million individuals diagnosed with diabetes and 400,000 diabetic foot infections visits annually and approximately 160,000 lower limb amputations in diabetic patients. Approximately 85% of amputations in diabetic patients are due to DFO or diabetic foot infection. Financially, the toll is huge, with each amputation entailing direct costs of approximately $50,000 per patient. The total financial burden on the U.S. healthcare system due to diabetic amputation is approximately $8 billion annually, a staggering figure.

Sadly, DFO or DFI patients that undergo amputation have an increased five-year mortality rate of 30% to 50%, and any episode of lower limb amputation is a major risk factor for subsequent amputation. Next slide. Given the unmet need, it is surprising that no new drugs have been approved for the last 20 years. Furthermore, all the drugs were approved for DFI on the basis of noninferiority to older antibiotics. Hence, there has been no real innovation in the field for more than two decades. Needless to say, in DFO, there are no drugs approved at all. Next slide. In meeting the huge unmet need for patients, we should look at the key drivers of treatment failure, which are formation of biofilm, poor blood supply, and general antibiotic resistance. Staphylococcus aureus forms biofilm patches in diabetic foot ulcers represented here in blue. Bacteria are represented in green.

Biofilm creates a shield that is 10-1,000-fold more resistant to antibiotics compared to free-floating individual cells, which are not part of the biofilm. Treatment is further complicated given poor blood supply, which limits the localized concentration and effectiveness of systemically administered IV or oral antibiotics. Many of these patients have antibiotic-resistant Staphylococcus aureus. Overall, half of chronic cases of DFO or DFI involve Staphylococcus aureus, mostly due to the rapidity of the microorganism doubling time in virulence factors. We believe the bacteriophage advantage includes the ability to break bacterial biofilm formation, in addition to its effectiveness against antibiotic-resistant bacteria. Once at the site of infection, phage microorganisms have the added advantage of replicating as they eliminate bacteria and hence amplify their concentration at the difficult-to-reach infection site. Next slide.

BX211 is a proprietary phage treatment that has been formulated to meet the needs of patients with DFO associated with Staph aureus. We believe that BX211 can be effective against antibiotic-resistant strains of Staph aureus in enabling the breakdown of biofilm, offering the potential to resolve infection, prevent clinical deterioration, improve wound healing, and aid DFO and DFI clinical resolution. All these are endpoints explored in the phase II study, the design of which we review in the next slide. Next slide. A total of 41 patients were enrolled in the study in a randomized two-to-one ratio of control to treatment group. Twenty-six patients received IV and topical administration of BX211 on week one, followed by a topical weekly dose through week 13, while 15 patients received placebo. All patients, treatment and placebo, were also treated in accordance with the standard of care, including antibiotic treatment as appropriate.

The primary endpoint of the phase II study was percent area reduction, or PAR, of study ulcer through week 13. Study design was guided in part by experience with compassionate cases using phage therapy for the treatment of DFO and osteomyelitis. Results readout was scheduled at week 13. Next slide. Let's now talk about the results. First of all, we did not see any safety issues. While not surprising to configure an extensive safety record, it is reassuring. Patients treated with BX211 demonstrate sustained and statistically significant PAR of ulcer size with a separation from placebo starting at week seven, with a difference greater than 40% by week 10. In addition, statistical significance was demonstrated in improvement of both ulcer death at week 13 and reduced worsening of ulcer area compared to placebo.

Ulcer depth of bone involvement at baseline was compared to deepest tissue involved as measured by swab at week 13. The study also captured additional clinical parameters demonstrating favorable trends for BX211 treatment of DFO compared to placebo. Among these, it was observed that the proportion of visits with no clinical evidence of infection was higher in the BX211 treatment group. BX211 also displayed favorable trends in resolution of DFO by MRI and X-ray at week 12, a 50% reduction from baseline in C-reactive protein and greater Wagner scale improvement. Finally, the study showed that through week 13, BX211 displayed comparable efficacy against both methicillin susceptible and resistant strains, as well as against high and low biofilm producers, consistent with the orthogonal mechanism of phage therapy to antibiotics and its inherent antibiotic capabilities. Next slide.

When talking to key opinion leaders in the field, our expectation for the trial was that BX211, given on top of standardized treatment, was capable of a 30% improvement over placebo. That would be impressive, and given that the study only had 41 patients, we had no expectations of attaining statistical significance. At least we hope we could see a signal within the data. However, we are thrilled to see the strength of the data, demonstrating improvement in ulcer size that exceeded 40% compared to our expectation of 30% and displaying statistical significance at week 12. Next slide. Additionally, we saw statistical significance in other parameters, including the depth of these ulcers.

When you look at these data, you can see quite clearly that patients treated with phage on the left had improved recovery compared to those on placebo, and this reached statistical significance at week 13. The dramatic impact compared to placebo can be seen here, with 12 out of 13 improving in the BX211 treatment group relative to the only five out of nine in the placebo arm. Interestingly, this supports further the potential effectiveness of BX211. As the previous ulcer measurement, PAR, showed reduction on the surface of the ulcer, this measurement demonstrates improvement in the depth of the ulcer. Next slide. We also looked at additional clinical parameters to get an understanding of the totality of the data, despite these not being powered to display statistical significance. Looking at MRI and X-rays, we saw that there was a tendency to see less of the infection at the bone.

Tissue involvement and blood inflammatory markers suggested signs of resolution of infection, and Wagner scale improvement was evident in addition to no worsening in ulcer area. There was also an increase in proportion of clinical evidence of infection worsening in the BX211 arm as well. Next slide. Overall, this is a very exciting time for phage, and we feel that the field has been expecting data like this for years. Finally, these phase II results marked, to the company's knowledge, the first well-controlled double-blinded placebo-controlled clinical study to demonstrate statistically significant efficacy of phage therapy in a clinical endpoint for chronic bacterial infection. The strength of the study is reinforced by the ability of BX211 to demonstrate a clinical effect on top of therapeutic care, including antibiotics, signifying the role the bacteriophage can play in the treatment of DFO patients.

Many of them waited for over two decades for new drug approvals in DFI or DFO. BX211 consistent performance across severity levels, infection profiles, and microbial resistance patterns position it as a potential game changer in the management of DFO and DFI. We hope BX211 will fill this unmet need as it progresses to the next clinical trial. Thank you all for tuning in today. I'll now turn you over to Marina who will discuss the company financial results.

Marina Wolfson (CFO)

Thank you, Jonathan. This has been a strong start to the year for BiomX. In February, BiomX announced a series of financings with total gross proceeds of approximately $12 million. Funds will support completion of our phase II B study of BX004 in patients with cystic fibrosis, or CF, who have chronic pulmonary infections caused by Pseudomonas aeruginosa.

We believe the funds attained will provide adequate runway to reach the readout of top-line phase II B results, which are expected in the first quarter of 2026. Additionally, a portion of the funds attained is being allocated towards the preparation for regulatory discussions on BX004 expected later this year. Ahead of these discussions, we're exploring and analyzing real-world evidence in people with CF to further understand the relationship between Pseudomonas aeruginosa reduction and clinical outcomes. We are grateful to Deerfield Management, the Cystic Fibrosis Foundation, Nantahala Capital, and our additional investors for their continued support throughout these recent financing rounds. For additional financing details, please refer to BiomX 2024 fourth quarter and full-year press release in 10-K issued on March 25th. Prior to opening up for questions, I wanted to add a reminder that BiomX will host a virtual event on April 3rd at 11:00 A.M.

Eastern Time, featuring prominent key opinion leaders in the field of bacterial phage therapy and diabetic foot infections. Together, we'll dive deeper into the results from the phase II trial of BX211 and DFO and explore the broader clinical and therapeutic implications of these findings. The insights shared by our expert panel will provide valuable context on how BX211 could shape the future of care for patients with DFO. Panelists joining us for this call will include Dr. Robert T. Schooley, M.D., Distinguished Professor of Medicine, Division of Infectious Diseases and Global Public Health, and Co-Director, Center for Innovative Phage Applications and Therapeutics at the University of California, San Diego, and Dr. Benjamin A. Lipsky, M.D., Professor of Medicine Emeritus at the University of Washington, Seattle. We encourage you all to join us for this important discussion.

The link to register for the event can be found in the bottom of the DFO press release issued this morning. With that, we would be happy to open up for questions.

Operator (participant)

Thank you. We're now conducting a question-and-answer session. If you'd like to be placed in the question queue, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove a question from the queue. One moment, please, while we pull for questions. Our first question today is coming from Joel Peng from H.C. Wainwright. Right, your line is now live.

Joe Pantginis (Managing Director of Equity Research)

Hey, everybody. Good morning. Thanks for taking the questions. First, let me offer a two-pronged congratulations. You alluded to this on your prepared comments, Jonathan.

First, for your clinical data here, and then second, as being a very important step forward for bacterial phage in general. I guess, before I ask some of the questions on the data here, I wanted to get a sense, especially in this current ongoing financing environment, the potential for additional non-dilutive capital from various sources, including potentially the Navy moving forward.

Jonathan Solomon (CEO)

Joe, good morning. Yes, right, we've waited many, many years together for this moment. We're obviously very excited, and thank you for the warm words. I do think it's a great question. Sort of interesting, the DHA has been supporting the company for a while with quite significant non-dilutive funding. We're looking at geopolitics as a very troubling condition, and one would wonder why would the Navy and the DHA kind of look into diabetic foot ulcers and osteomyelitis.

Interestingly, they've been looking basically in monitoring bowel wounds out of Ukraine, and quite a lot of the troops are coming back with drug-resistant infections. I think some of the U.S. defense establishment has sort of identified phage as a potential key modality, investing in several companies in the field to try to kind of think about what will be the next thing when U.S. soldiers are facing these threats and resistant infections. That's been the rationale. I think we've been very fortunate to get their support. I think there's interest to continue that support, and that could provide, I think, a solid and very substantial non-dilutive funding.

Joe Pantginis (Managing Director of Equity Research)

No, that's very helpful. Thanks. If I dive into the data a bit, again, two-pronged question here. Wanted to get a sense of first the benchmarking with regard to the patients involved in the study here.

You did allude to this as part of the general population, but for this particular study and the demographics, first, what would you consider the natural course of disease for these patients? I mean, could you consider, as part of the answer, spontaneous healing of the patients? What percentage could that be? Anything else you wanted to add? That is first. The second is, what are your thoughts on how the control arm performed in this study, say, relative to the general population of DFO?

Jonathan Solomon (CEO)

The two, I think, very good questions. I think the first one regarding the patient population. These are very—and again, we are fortunate to kind of run and get some feedback from some of the top KLs that will listen to them in the KL call. This is a very typical patient population with DFO.

Unfortunately, for our gender, it's a majority males, median age around 60. That's kind of the way the patient population looks like in these conditions. Again, it's very dire need, in which, in the case specifically of DFO, 40% of the patients with DFO will end up with an amputation, right? You have slightly less than half of them kind of not improving, deteriorating, and ending up in very unfortunate conditions. As we recall, the expectations for the study on the placebo arm is on standard of care. Usually, one would see an average ulcer shrink. The expectation was around 40%, and that's what we've seen, right? You have a large chunk of these patients which are not responding to therapy and kind of deteriorating over time, hence the great unmet need.

I think to your point about the second question about the placebo response, and especially if you look at the graph—and for those that have not managed to follow the slides, I mean, the deck is available on our website. The corporate website is there, and we will kind of highlight it so you can see it. Hold on. Basically, you see, again, the data that we are extremely excited. You see the separation to 40%, right? If you think about the expectations that we had coming into the study, placebo is kind of hovering around 40-35% as we have expected, right? Treatment, we recall many of our conversations together, we guided to see like a 30% improvement over treatment. We are getting something closer to 40% with stat sig at week 12 and a very strong signal at week 13. Obviously, very exciting.

I do think one of the questions that we looked into and said, it separates after like week six. What's going on, right? Why is the separation not happening earlier? As we kind of talked to the clinicians and the KOL, because these patients have a lot of comorbidities and they're not usually kind of taking care of themselves properly, being enrolled in a clinical study does have its effect. Again, placebo is getting standard of care, which is not only antibiotics, but also debridement, right? They're coming to the clinic every week. Probably they're benefiting from the better care than their kind of day-to-day care. I think that's where we're seeing some placebo response as well in the first few weeks.

But then after a while, right, they kind of average out to what we know is expected in this patient population around the 40%. Interestingly, to the point, the phage group is still continuing to improve, right? Which is why one of the reasons we're so excited. They're continuing to improve over time. I think that could be driven by a few factors, right? Beyond what we talked about the placebo, I think it's the fact that we're probably the phage or grinding biofilm, which is not an exponential process, so more of a linear process. As you give more and more treatment, hopefully you're clearing out more of the biofilm and enabling greater healing. As well as over time, you might be exposing more of these bacteria and kind of, again, kind of improving all the healing and more phage meets bacteria.

Because again, these are patients with very poor blood supply, a ton of biofilm. You might be needing to kind of dose over and over until you're getting enough phage to kind of start that chain reaction. I hope that kind of addresses both issues.

Joe Pantginis (Managing Director of Equity Research)

Oh, it certainly does. Appreciate that. If you indulge me a little bit more, please, or I could jump back in the queue. In this study, and I know maybe the data are obviously new and you're still analyzing things, when you look at not only these data, but even your prior cystic fibrosis studies, you're getting constant learnings with regard to the dosing regimen and the time of application. Do you have any early learnings here that might be applied forward?

Jonathan Solomon (CEO)

Probably still early to tell, right?

I think here in this study, we're seeing a more gradual response over time that opens up versus the CF, which we saw some of the patients that had the complete kind of complete eradication very quickly. I bet it depends on the route of delivery, which is some of the lessons that we've learned in the past, right? I think we can translate. We feel comfortable that all our in vitro work does translate to activity. We're very fortunate to be in this position. I think the careful screening in this, we literally took bone biopsy from every patient and made sure that we can grow the bacteria and characterize them and make sure that the phage is susceptible to it. A lot of it was relevant across both studies and translated well.

I think route of delivery and sort of probably the geography of the infection makes a big difference. Because in CF, they're probably more accessible in the lungs, and we saw a rapid response when kind of hit. Here we're seeing that over time, and it's quite interesting that over time what you're seeing is that the phage group just continues to improve, right? So we're kind of grinding maybe these biofilm, kind of taking out whatever bacteria become available, and just over time it gets better.

Joe Pantginis (Managing Director of Equity Research)

Got it. My last question, and thank you again, is to is a bit forward-looking.

You might not want to touch this yet, but anything with regard to a first swing at the phase III potential sizes, looking to the expectations here of similar like 30% to 40% increases, size of the study, and would you be seeking any potential regulatory designation such as breakthrough status?

Jonathan Solomon (CEO)

To your point, right, a bit early, I think we're very excited and very pleasantly surprised by the quality of the data, right? That gives us so much information moving forward. I can share, I think some of the thinking because some of the endpoints that we're seeing here are on soft tissue. I think that's why one can look into the moderate to severe diabetic foot infections as well as osteomyelitis. I think that's some of our thinking.

Really fine-tuning the next steps will require obviously regulatory consultation, talking with our partners at the DHA, kind of strategizing what's the best path forward.

Joe Pantginis (Managing Director of Equity Research)

Got it. Thank you for all the answers, Jonathan, and congrats again.

Jonathan Solomon (CEO)

Thank you. Always a pleasure.

Operator (participant)

Thank you. As a reminder, that star one to be placed in the question queue. Our next question is coming from Yale Jen from Laidlaw & Company. Your line is now live.

Yale Jen (Senior Managing Director and Senior Biotech Analyst)

Good morning, and thanks for taking the questions. This is a very great positive surprise. Congrats on that, Jonathan. A few quick questions. The first one is that the p-value at 13 weeks is slightly above 0.05, whereas 12 weeks is under. Is there any thought to impact on that or simply just the small study size?

Jonathan Solomon (CEO)

Yeah, I think a great question. I think it's a very small study size.

If you recall, the original guidance was we weren't even expecting any stat. SIG anywhere because of the only 41 patients. I do think the strength of the data produced the kind of statistical significance that we're seeing. Yes, week 12, we're at 0.046. At week 13, we're kind of barely scratching the almost stat. SIG, so extremely pleased with that data. I will highlight, I think when you look at the totality of the data on top of what we saw in PAR, right, reaching that point and kind of clarity, when you look at the next slide, for example, slide 13, that is what we do, right? We take a Q-tip and we're trying to see how deep we can go into the tissue. We looked at those patients that the ulcer was so deep that we could literally get to the bone.

You could see these kinds of dramatic effects, right? That's a clear statistical significance signal as well with 12 out of 13 patients basically experiencing quite a significant improvement, right? That's very clear stat. SIG. Again, we did not expect stat. SIG in such a small number, right? I think that's what's so exciting. Talking to some of the KOLs, they kind of said, "Look, we're looking for initial signals." Here we're seeing something very definitive. I think the totality of the data looks very good. I will highlight to your point, there's another way of looking at the PAR just to see whether ulcers are worsening, right? Because what you're really worried about and the issue in these patients is when an ulcer starts growing out of control and then the patient experiences amputation. That's what's called an ulcer worsening.

I think in the fourth plot on slide 14, you could see that even when we're measuring worsening in ulcer area, that ulcer reaches kind of stat. SIG as well, right? On top of the tissue involvement, on top of what we've seen in PAR. I think that's why we're so excited. Just the totality of the data, the measurements that are reaching stat. SIG, although we didn't expect in several of the others, kind of points, I think, a very favorable picture moving forward.

Yale Jen (Senior Managing Director and Senior Biotech Analyst)

Great. That's very helpful. Maybe just continue in terms of both the depth and the area changes that you highlight here. You mentioned this is also gonocole. No differences between the phage treatment versus the antibiotics. Could you elaborate more on that? Because I think this is probably one of the factors that you see such dramatic improvement changes.

Jonathan Solomon (CEO)

Just, Yale, can you repeat the question? You said difference with antibiotics? Or I'm not sure I followed the question completely.

Yale Jen (Senior Managing Director and Senior Biotech Analyst)

Yeah, yeah. I mean, basically talking about also general differences between the antibiotics versus the phage treatment.

Jonathan Solomon (CEO)

Yeah. If I understand the question correctly, both placebo as well as phage groups are being treated with a standard of care, right? It is a physician choice. They are all given antibiotics. Most of them are getting debridements, right? Think about placebo is getting debridement, which is quite an invasive procedure in which a surgeon kind of cleans the wound trying to facilitate recovery. You see how bad it is that with all these interventions on a weekly basis, whether it is systemic or oral antibiotics, still the ulcers are not really improving that much in the majority of the cases, right?

I think that's why it's dramatic. The phage group got the same treatment, I mean, debridement plus antibiotics, and on top of it, the phage, right? Again, the phage is orthogonal to the antibiotics, so it doesn't interact. There are a lot of data that sometimes is synergistic. We know it doesn't care about antibiotic resistance. I think the amplification and the biofilm points are probably what's leading to this kind of continuous effect and continuous improvement that we're seeing that on.

Yale Jen (Senior Managing Director and Senior Biotech Analyst)

Okay, great. That's very helpful. The next question I have is that in terms of the chart, it's very impressive. You see the separation clearly from week five, six. My question to you is that is that historically similar in terms of the placebo with. Start to see the effect become reduced and therefore the curve going upward.

That will be something consistent with the real-world situation. Therefore, going forward, in your phase III study, you will probably envision similar sort of patterns to be seen.

Jonathan Solomon (CEO)

I think to your question, there isn't a lot of data of being monitoring on a weekly basis the size of the ulcer.

Yale Jen (Senior Managing Director and Senior Biotech Analyst)

Correct.

Jonathan Solomon (CEO)

There is limited data. A lot of times, like after treatment and before treatment, and on average, it is 40%, right? I think where you see kind of the placebo group hovering is actually what's expected on the meta-analysis. I think that's the guidance that we saw as well, right? It is a well-performing placebo group. I think, right, when you look at it, you're saying some worsening, and then again, that could be still in a larger number, it might sort of all flatten out.

To be with a placebo group around 40% is actually what's expected. I will say, given the data that we have and after consultation with the KOLs, this is kind of a well-performing and as expected placebo group. Hopefully that's what we see in the phase III as well. So long as our, of course, placebo group performs as the same as in this study as well, I think we'll be in a good spot.

Yale Jen (Senior Managing Director and Senior Biotech Analyst)

Okay. Maybe last two quick questions. First of all, we know the phage treatment is very safe. Would you elaborate a little bit more in terms of specific AE or anything that's worth mentioning?

Jonathan Solomon (CEO)

Great question, right? We'll, of course, present all the data in an upcoming scientific conference. In general, this is not a healthy population, right? Adverse events are expected.

We have not seen any difference between phage and placebo in any severe adverse events, which is treatment-related or anything like that. I think it continues, again, with some of the observation we've seen in our CF study and other studies in the past. Phage looks like a very safe modality, and hence I think the great potential, right? It's a safe modality. We're seeing activity. It's selective, and it's orthogonal to antibiotics.

Yale Jen (Senior Managing Director and Senior Biotech Analyst)

The last question you actually just mentioned in terms of either publication or medical conferences, was anything in mind at this point, particularly in the medical conferences? Thanks.

Jonathan Solomon (CEO)

This is hot off, yeah, it's hot off the press. We're consulting with some of the KOLs, and again, we'll give guidance once we will start kind of putting together the abstract. Yes, I think we're excited.

Again, as we said, I think this is a potentially pivotal moment for phage therapy, right? We're not aware of any data of this quality and showing clinical effect with statistical significance. We're very eager to find kind of the right context to publish and share more of the data.

Yale Jen (Senior Managing Director and Senior Biotech Analyst)

Okay, great. Thanks again. Absolutely a positive surprise, and congrats on your effort, and the things come out great on the other side. Congrats.

Jonathan Solomon (CEO)

Thank you, Yale. Thank you for the kind words.

Operator (participant)

Thank you. We've reached the end of our question-and-answer session. I'd like to turn the floor back over for any further closing comments.

Jonathan Solomon (CEO)

I wanted to thank everyone for taking the time, and I hope you share our excitement with the data.

We'll update you on upcoming events, and I'll just remind everyone of the KOL event happening on Thursday and have a good morning. Thank you.

Operator (participant)

Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation.