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BiomX Inc. Stock Price: Quote, Forecast, Splits & News (PHGE)

Perplexity Finance

Company Profile

BiomX Inc. Price & Performance (PHGE)

Stock Performance

Updated Apr 21, 4:59 PM UTC

BiomX Inc.

$0.53USD

-$0.0098 (-1.82%)

Open

$0.54

Market Cap

$13.23M

Year High

$4.99

High

$0.57

P/E Ratio

-0.4

Year Low

$0.48

Low

$0.52

Dividend Yield

0.00%

Volume

31.44K

Latest News

Analysts Boost BiomX Price Target After Positive Phase 2 Trial Results
Apr 1, 2025
H.C. Wainwright raised BiomX’s price target to $21 following strong Phase 2 trial data for BX211 in diabetic foot osteomyelitis. The therapy showed significant improvements in ulcer size and infection control, marking a key milestone for phage-based treatments. Despite financial headwinds, the company is preparing for a potential Phase 3 trial.123
OTC Markets Adds BiomX Amid Ongoing Financial Scrutiny and R&D Efforts
Apr 20, 2025
BiomX was welcomed to the OTCQB market today, as the company continues to advance phage therapies for chronic diseases. However, auditors recently issued a going concern opinion, highlighting ongoing financial risks. BiomX’s liquidity is sufficient only into early 2026, necessitating further funding for long-term operations.456
Funding Secured for BiomX’s Cystic Fibrosis Phage Therapy Development
Apr 20, 2025
BiomX recently secured $12 million in financing to support the Phase 2b trial of BX004, targeting P. aeruginosa infections in cystic fibrosis patients. The funds will also back research into real-world impacts and regulatory engagement, with topline results expected in early 2026. The Cystic Fibrosis Foundation remains a key backer.135

What's Happening

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Earnings

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Report Period

Q4 2024

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Transcript

31s

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, BioNex issued a press release detailing top line results from the Phase two study that became available just after 06:30AM Eastern Time. In addition, the presentation slides used on this call can be found on our website at bionix.com. Bionix also issued a press release on twenty twenty four fourth quarter and full year financials and program updates on March 25. A replay of this call will be available on the Investors 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 with efficiency of the company's cash, our pipeline, the design, recruitment, aims, 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 candidates, BX004 and BX211, as well as the potential outcomes of discussions that we may have with the U. S. Food and Drug Administration or FDA and foreign regulatory agencies and timing thereof.

In addition, past and current preclinical and clinical results as well as Compassionate's 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 Seliman, to whom I will now turn over the call to discuss the positive DFO readout.

2m 36s

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 stage 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 receptorly. Both programs have now successfully completed Phase II trials and today we will take the time to focus on the readout of the Phase II results of BX211 oriented to meet the need of patients with DSO associated with staphylococcus aureus. We are fortunate to have great investors and partners on the path to making FADE widely available and accessible just to mention a few Deerfield Management, the Antimicrobial Resistant 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 two trial evaluating BX-two eleven a phage treatment for staphylococcus aureus infections in patients with DFO. The results are a watershed moment for phage therapy. BX-two eleven 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.

3m 59s

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 infection of the soft tissue in patients with diabetes that begin a superficial ulcer and then deepen and extend into the subcutaneous layer. As these infections further benefit and spread into the bone, these are then characterized as DFO. Staphylococcus aureus infection 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 twenty percent to forty percent of these cases that should result 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 thirty eight million individuals diagnosed with diabetes and four hundred thousand diabetic foot infections ER visits annually and approximately one hundred and sixty thousand lower limb amputations in diabetic patients. Approximately eighty five percent of amputation in diabetic patients are due to DSO or diabetic Financially, the total is huge with each amputation entails direct costs of approximately $50,000 per patient.

5m 26s

The total financial burden on The U. S. Healthcare system due to diabetic amputation is approximately USD 8,000,000,000 annually, a staggering figure. Sadly DFO or DFI patients that undergo amputation have an increased five year mortality rate of thirty percent to fifty percent 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 twenty years. Furthermore, all the drugs were approved for DSI on the basis of non inferiority 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 meetings a huge unmet need for patients, we should look at the key drivers of treatment fail, which are formation of biofilm, poor blood supply, general antibiotic resistance. Staphorus forms biofilm patches in diabetic foot ulcers represented here in blue. Bacteria are represented in green. Biofilm creates a shield that is 10 to 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.

6m 56s

And many of these patients have antibiotic resistant staphors. Overall, half of chronic cases of DFO and DFI involve staphors mostly due to the rapidity of the microaccharinism, doubling time and virulence factors. We believe the Bikurifase advantage includes the ability to break bacterial biofilm formation in addition to its effectiveness against antibiotic resistance bacteria. Once at the site of infection, Phase Mark organisms have the added advantage of replicating as they eliminate bacteria and hence amplifying their concentration at the difficult to reach infection sites. Next slide. VX211 is our proprietary phage treatment that has been formulated to meet the needs of patients with DSO associated with staph aureus. We believe that VX211 can be effective against antibody resistant strain of staph aureus and in enabling the breakdown of biofilm, offering the potential to resolve infection, prevent clinical deterioration, improve wound healing and A DSO and DFI clinical resolution. All these are endpoints explored in the Phase two study, the design of which we review in the next slide. Next slide. A total of forty one patients were enrolled in the study in a randomized two:one ratio of control to treatment group. Twenty six patients received IV and topical administration of VX211 on week one, followed by a topical weekly dose through week thirteen, while fifteen patients received placebo.

8m 28s

All patient treatment and placebo were also treated in accordance with the standard of care including antibody treatment as appropriate. The primary endpoint of the Phase two study was percent area reduction or PAR of study ulcer through week thirteen. Study design was guided in part by experience with compassionate cases using phage therapy for the treatment of DSO and nonceomyelitis. Results readout was scheduled at week thirteen. Next slide. Let's now talk about the results. First of all, we did not see any safety issues. While not surprising in phage extensive safety record, it is reassuring. Patient 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 ten. In addition, statistical significance was demonstrating improvement of both ulcer death at week thirteen and reduced worsening of ulcer area compared to placebo. Also death of bone involvement at baseline was compared to deepest tissue involved as measured by swab at week thirteen. The study also captured additional clinical parameters demonstrating favorable trends for BX211 treatment of DSO compared to placebo. Among these, it was observed that the proportion of visits with no clinical evidence of inflection was higher in the BX211 treatment group.

9m 58s

BX211 also displayed favorable trends in resolution of DSO by MRI x-ray at week twelve, a 50% reduction from baseline in C reactive protein and greater Wagner scale improvement. Finally, the study showed that through week thirteen, BX211 displayed comparable efficacy against both methylene susceptible and resistant strain as well as against high and low bivalve producers consistent with the orthogonal mechanism of phage therapy to antibiotics and its inherent anti biopharm capabilities. Next slide. When talking to key opinion leaders in the field, our expectation for the trial 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. But at least we hope we could see a signal within the data. However, we are thrilled to see the strength of the data, demonstrating proven in also 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 thirteen.

11m 28s

The dramatic impact compared to placebo can be seen here with twelve out of thirteen improving in BX2-oneone treatment group relative to the only five out of nine in the placebo arm. Interestingly, this supports further the potential effectiveness of BX-one hundred and eleven as the previous ulcer measurement, PAR, showed reduction on the surface of the ulcer. This measurement demonstrates improvement in the death of the ulcer. Next slide. We also looked at additional clinical parameters to get an understanding of its 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 suggest the 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 this clinical evidence of infection worsening in the BX211 arm as well.

12m 33s

Next slide.

12m 35s

Overall, this is a very exciting time for Sage and we feel that the field has been expecting data like this for years. Finally, these Phase two results mark to the company's knowledge the first well controlled double blinded placebo controlled clinical study to demonstrate statistically significant efficacy of Phase therapy in a clinical endpoint for a chronic bacterial infection. The strength of the study is reinforced by the ability of BX211 to demonstrate a clinical effect on top of safety including antibiotics signifying the role that BRAFH 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, microbial resistant patterns position it as a potential changer in the management of VFO and DFI. We hope BX211 will fill this unmet need as it progresses in the next clinical trial. Thank you all for tuning in today. I'll now turn you over to Marina that will discuss the company financial results.

13m 38s

Thank you, Jonathan. This has been a strong start to the year for BioMx. In February, BioMx announced a series of financing with total gross proceeds of approximately $12,000,000 Funds will support completion of our Phase 2b study of BH004 in patients with cystic fibrosis or CF, who have chronic pulmonary infections caused by Pseudomonas aerodymosa. We believe the funds attained will provide adequate runway to reach the readout of top line Phase 2b results, which are expected in the first quarter of twenty twenty six. Additionally, a portion of the funds attained is being allocated towards the preparation for regulatory discussions and VX004 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 Company, the Cystic Fibrosis Foundation, Mantahala Capital and our additional investors for their continued force throughout these recent financing rounds. For additional financing details, please refer to BioMx twenty twenty four fourth quarter and full year press release and 10 K issued on March 25. Prior to opening up for questions, I wanted to add a reminder that BioMx will host a virtual event on April 3 at eleven a.

15m 2s

M. Eastern Time, featuring prominent key opinion leaders in the field of bacteriophage therapy and diabetic fluid infections. Together, we'll dive deeper into the results from the Phase two trial of BX211 in DSO 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. ALLs joining us for this call will include Doctor. Robert T. Chip Schooley, MD, Distinguished Professor of Medicine, Division of Infectious Diseases and Global Public Health and Co Director, Center for Innovative Sage Applications and Therapeutics at the University of California, San Diego and Doctor. Benjamin A. Lipsky, MD, 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.

16m 9s

Thank you. We'll now be conducting a question and answer session. Our first question today is coming from Joe Pantginis from H. C. Wainwright. Your line is now live.

16m 34s

Hey, everybody. Good morning. Thanks for taking the questions. And first, let me offer a two pronged congratulations. And 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 bacteriophage in general. So 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?

17m 10s

Joe, good morning. And yes, right, we've waited many, many years together for this moment. So we're obviously very excited and thank you for the warm words. I do think it's a great question and sort of interesting with the DHA has been supporting the company for a while with quite significant non diluted funding. And we are looking at geopolitics as a very troubling condition. And one would wonder, why would the Navy and the BHA kind of look into diabetic foot ulcers and osteomyelitis. And 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. So I think some of The U. S. Defense establishment has sort of identified phage as a potential key modality invested 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. So 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 can provide I think a solid and very substantial non dilutive funding.

18m 23s

No, that's very helpful. Thanks. And 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. So and you did allude to this as part of the general population, but for this particular study and the demographics, what 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's first. And then the second is, what are your thoughts on how the control arm performed in this study, say, relative to the general population of DFO?

19m 8s

The two, I think very good questions. So I think the first one regarding the patient population. So these are very and again, we're fortunate to kind of run and get some feedback from some of the ticked top KOLs that will listen to them in the KOL call. But this is a very typical patient population with DSO. Unfortunately for our gender, it's the majority males, median age around 60. And that's kind of the way the patient population looks like in these condition. Again, it's very dire need in which in the case specifically of DFO, forty percent of the patients with DFO will end up with an amputation, right? So 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 right and the placebo arm is on standard of care. Usually one would see an average also shrinking the expectation was around forty percent and that's what we've seen, right? So 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 haven't match up all of the slides, I mean the deck is available on our website.

20m 30s

The corporate website is there and we'll kind of highlight it so you can see it. Hold on. So basically you see again the data that we're extremely excited, you see the separation to 40%, right? So if you think about the expectations that we have coming into the study, placebo is kind of hovering around forty percent, thirty five percent as we've expected, right treatment. We recall many of our conversations together, we guided to see like a thirty percent improvement over treatment. We're getting something closer to forty percent with STAT SIG at week 12 and a very strong signal at week 13. So obviously very exciting. I do think one of the questions that we looked into and said, it separates after like week six. So what's going on, right? Why is the separation not happening earlier? And as we kind of talked to the clinicians and the KOL, because these patients have a lot of comorbidities and they're not usually taking care of themselves properly, being enrolled in a clinical study does have its effect. And again, placebo is getting standard of care, which is not only antibiotics, but also debridement, right? So they're coming up, they're coming to the clinic every week.

21m 41s

So probably they're benefiting from a better care than their kind of day to day care. So 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 amount of forty percent. And interesting 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 phase or grinding biofilm, which is not an exponential process or more of a linear process. As you get 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. So you might be needing to kind of dose over and over until we're getting enough phage to kind of start that chain reaction.

22m 43s

So I hope that kind of addresses both of those.

22m 46s

It certainly does. Appreciate that. And then if you indulge me a little bit more, please, or I could jump back in the queue. But in this study and I know maybe the data are obviously new and you're still analyzing things. But 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?

23m 19s

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 to complete kind of 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? So 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 it and make sure that the phase is susceptible to it. So a lot of it was relevant across both studies and translated well, but I think rather 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 it 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.

24m 23s

So kind of grinding maybe these biofilm kind of taking out whatever bacteria become available and just over time it gets better.

24m 31s

Got it. And my last question and thank you again is to it's a bit forward looking, you might not want to touch this yet, but anything with regard to a first swing at the Phase three potential sizes, looking to these the expectations here of similar like 30% to 40% increases, size of the study and would you be seeking any potential regulatory designations such as breakthrough status?

25m 1s

So 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 between some of the endpoints that we're seeing here are on soft tissue.

25m 16s

I think that's why Juan can look into like the moderate to severe diabetic foot infections as well as osteomyelitis. So I think that's some of our thinking, But 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.

25m 34s

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

25m 38s

Thank you. It was a pleasure. Thank you. Our next question is coming from Gail Jain from Laidlaw and Company. Your line is now live.

25m 51s

Good morning and thanks for taking the questions and this is a very great positive surprise. Congrats on that, Jonathan. So a quick question. The first one is that the p value of thirteen weeks is slightly above five zero five versus twelve weeks is under. Is there any thought impact on that or simply just the small study size?

26m 24s

Yes, 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 it's only 41 patients. I do think the strength of the data produce the kind of statistical significance that we're seeing. So yes, week 12 we're at 0.046 at week 13 we're kind of barely scratching the almost stat six. 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 on par, right, reaching that point and kind of clarity.

27m 1s

When you look at the next slide, for example, Slide 13, so 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 and you could see these kinds of dramatic effects, right? So that's a clear statistical significant signal as well with twelve out of thirteen patients, basically experiencing quite a significant improvement, right. So that's very clear stat sig. And again, we did not expect stat sig in such a small number, right. I think that was so exciting and 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 and I will highlight to your point, there's another way of looking at ulcers 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 experienced amputation. So that's what's called an ulcer worsening.

28m 5s

And I think in the fourth slot on Slide 14, you could see that even the when we're measuring worsening in ulcer area and also reaches kind of stat sig as well, right, on top of the tissue involvement, on top of routine and par. So I think that's why we're so excited, just the totality of the data, the measurements that are reaching SCAT SIG, although we didn't expect in several of the others, kind of point, I think, a very favorable picture moving forward.

28m 33s

Great. That's very helpful. Maybe I'll just continue in terms of the depth and area changes that you highlighted here. You mentioned that this is also a clinical differences between your the base 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?

29m 5s

Yes, Yale, can you repeat the question? You said difference with antibiotics or I'm not sure I followed the question, please?

29m 11s

Yes, yes. I mean, basically, you talked about the orthogonal differences between the antibiotics versus the phage treatment? Yes. So basically, if I understand the question correctly, both placebo as well as phage groups are being treated with a standard of care, right? So it's a physician choice. They're all given antibiotics, they're given most of them, they're getting debridement, right? So think of that placebo is getting debridement, which is quite an invasive procedure in which surgeon kind of cleans the wound trying to kind of facilitate recovery. And you see how bad it is that with all these interventions on a weekly basis with whether it's systemic or oral antibiotic, still the ulcers are kind of not really improving that much in the majority of the cases, right? And 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? And again, the phage is orthogonal to the antibiotics, it doesn't interact. But there are a lot of data that sometimes is synergistic. We know it doesn't care about antibiotic resistance. And I think the amplification, the biopharma points are probably what's leading to this kind of continuous effect and continuous improvement that we're seeing that on.

30m 26s

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 do you is that historically similar in terms of the placebo will start to see the effect will become reduced and therefore the curve going upward. So that will be something consistent with the real world situation. So therefore going forward and your Phase three study will probably envision similar sort of patterns to be seen?

31m 12s

So I think to your question, there isn't a lot of data of being monitored on a weekly basis the size of the ulcer. So there's limited day a lot of times like after treatment and before treatment and on average, it is forty percent, right? So 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. So 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. But to be with the placebo group around 40% is actually what's expected. So I will say given the data that we have and after consultation with the KOL, this is kind of well performing and as expected placebo group. And 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.

32m 14s

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

32m 31s

Great question. Right. We'll of course present all the data in an upcoming scientific conference. But in general, this is not a healthy population, right. So adverse events are expected. But we have not seen any difference between phage and placebo in any severe adverse events, which is treatment related or anything like that. So 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.

33m 8s

And the last question you actually just mentioned in terms of either publication or medical conferences with anything in mind and at this point particularly in the medical conferences?

33m 21s

So this is hot off yes, 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. But yes, I think we're excited. This is again, as we said, I think this is a potentially pivotal moment for the face therapy, right? We're not aware of any data of this quality and showing clinical effect with statistical significance. So we're very eager to find kind of the right context to publish and share more of the data.

33m 51s

Okay, great. Thanks, Tian. It's absolutely a positive surprise and congrats on your effort and the things come out great on the other side. So congrats.

34m 4s

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

34m 7s

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 or closing comments.

34m 15s

So 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 the KOL event happening on Thursday and have a good morning. Thank you.

34m 29s

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

Key Insights

BioNex (PHGE) announced positive top-line results from its Phase II trial of BX211, a phage therapy for Staphylococcus aureus infections in diabetic foot osteomyelitis (DFO), demonstrating statistically significant improvements in ulcer size and depth compared to placebo, with separation exceeding 40% by week 10 and statistical significance at week 12.
BX211 showed favorable trends across multiple additional clinical parameters, including higher rates of infection resolution, improved MRI/X-ray findings, reduced C-reactive protein, and greater Wagner scale improvement, with efficacy observed against both methicillin-susceptible and resistant strains.
The study enrolled 41 patients (2:1 randomization), all receiving standard of care (antibiotics and debridement); BX211 was administered IV and topically, with no safety issues or increase in adverse events compared to placebo.
BioNex recently raised approximately $12 million in gross proceeds to fund ongoing clinical programs, including the Phase 2b study of BX004 in cystic fibrosis, with top-line results expected in Q1 2026; funds will also support regulatory preparations for BX004 later this year.
Management highlighted the potential for additional non-dilutive funding from defense agencies, the strong unmet need in DFO (no new drugs approved in 20 years), and plans for further regulatory discussions and potential publication/presentation of the Phase II data at upcoming medical conferences.

Recent Transcripts

BX211 Phase II trial showed statistically significant efficacy for diabetic foot osteomyelitis.

Mar 31

Q4 2024 & Study Result

Income Statement

Revenue

	2020	2021	2022	2023	2024
Revenue	$0	$0	-$134K	-$357K	$0
Cost of Revenue	$2.2M	$2.6M	$2.5M	$871K	$0
Gross Profit	-$2.2M	-$2.6M	-$2.7M	-$1.2M	$0
Gross Profit %	undefined	undefined	2K%	344%	0%
R&D Expenses	$21M	$23M	$16M	$19M	$25M

2020

2021

2022

2023

2024

Revenue

-$134K

-$357K

Cost of Revenue

$2.2M

$2.6M

$2.5M

$871K

Gross Profit

-$2.2M

-$2.6M

-$2.7M

-$1.2M

Gross Profit %

undefined

2K%

344%

R&D Expenses

$21M

$23M

$16M

$19M

$25M

Cash Flow

Net Income

	2020	2021	2022	2023	2024
Net Income	-$30M	-$36M	-$28M	-$26M	-$18M
Dep. & Amort.	$2.2M	$2.6M	$2.5M	$871K	$1.8M
Def. Tax	$0	$24K	$0	$0	$0
Stock Comp.	$2.9M	$3.2M	$1.5M	$1.1M	$1.8M
Chg. in WC	$453K	$3.1M	-$4.4M	$2.5M	-$3M

2020

2021

2022

2023

2024

Net Income

-$30M

-$36M

-$28M

-$26M

-$18M

Dep. & Amort.

$2.2M

$2.6M

$2.5M

$871K

$1.8M

Def. Tax

$24K

Stock Comp.

$2.9M

$3.2M

$1.5M

$1.1M

$1.8M

Chg. in WC

$453K

$3.1M

-$4.4M

$2.5M

-$3M

Balance Sheet

Cash

	2020	2021	2022	2023	2024
Cash	$36M	$62M	$31M	$16M	$0
ST Investments	$20M	$0	$2M	$0	$0
Cash & ST Inv.	$56M	$62M	$33M	$16M	$17M
Receivables	$0	-$108K	$567K	$574K	$1.2M
Inventory	$0	$108K	$395K	$0	$0

2020

2021

2022

2023

2024

Cash

$36M

$62M

$31M

$16M

ST Investments

$20M

$2M

Cash & ST Inv.

$56M

$62M

$33M

$16M

$17M

Receivables

-$108K

$567K

$574K

$1.2M

Inventory

$108K

$395K

Go Deeper

Financial information provided by Financial Modeling Prep. Options data provided by Unusual Whales. Live transcripts provided by Quartr. All data is provided for informational purposes only, and is not intended for trading purposes or financial, investment, tax, legal, accounting or other advice. · See all tickers.

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Transcript

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Next slide.

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Thank you. We'll now be conducting a question and answer session. Our first question today is coming from Joe Pantginis from H. C. Wainwright. Your line is now live.

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So I hope that kind of addresses both of those.

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So kind of grinding maybe these biofilm kind of taking out whatever bacteria become available and just over time it gets better.

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25m 34s

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

25m 38s

Thank you. It was a pleasure. Thank you. Our next question is coming from Gail Jain from Laidlaw and Company. Your line is now live.

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Yes, Yale, can you repeat the question? You said difference with antibiotics or I'm not sure I followed the question, please?

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And the last question you actually just mentioned in terms of either publication or medical conferences with anything in mind and at this point particularly in the medical conferences?

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33m 51s

Okay, great. Thanks, Tian. It's absolutely a positive surprise and congrats on your effort and the things come out great on the other side. So congrats.

34m 4s

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

34m 7s

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 or closing comments.

34m 15s

34m 29s

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

Key Insights

BioNex (PHGE) announced positive top-line results from its Phase II trial of BX211, a phage therapy for Staphylococcus aureus infections in diabetic foot osteomyelitis (DFO), demonstrating statistically significant improvements in ulcer size and depth compared to placebo, with separation exceeding 40% by week 10 and statistical significance at week 12.
BX211 showed favorable trends across multiple additional clinical parameters, including higher rates of infection resolution, improved MRI/X-ray findings, reduced C-reactive protein, and greater Wagner scale improvement, with efficacy observed against both methicillin-susceptible and resistant strains.
The study enrolled 41 patients (2:1 randomization), all receiving standard of care (antibiotics and debridement); BX211 was administered IV and topically, with no safety issues or increase in adverse events compared to placebo.
BioNex recently raised approximately $12 million in gross proceeds to fund ongoing clinical programs, including the Phase 2b study of BX004 in cystic fibrosis, with top-line results expected in Q1 2026; funds will also support regulatory preparations for BX004 later this year.
Management highlighted the potential for additional non-dilutive funding from defense agencies, the strong unmet need in DFO (no new drugs approved in 20 years), and plans for further regulatory discussions and potential publication/presentation of the Phase II data at upcoming medical conferences.

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