BiomX Inc. (PHGE) Q1 2025 Earnings Report, Transcript and Summary

Greetings and welcome to the BiomX First Quarter 2025 Financial Results Conference Call. At this time, all participants are in a listen-only mode. The question-and-answer session will follow the formal presentation. [Operator Instructions] Please note this conference is being recorded. I will now turn the conference over to Marina Wolfson, Chief Financial Officer. Thank you. You may begin.

Thank you. And welcome to the BiomX conference call to review the company's first 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 biomix.com. A replay of this call will also be available in the Investors section of our website. As we begin, I'd like to review the safe harbor provision. All statements on this call that are not factual historic statements may be deemed forward-looking statements. For instance, we're using forward-looking statements when we discuss in the conference call, the sufficiency of the company's cash, our pipeline, the design recruitment, expected timing and interim and final results of our clinical trials, expected discussions with 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 BX004 and BX211 and the potential markets and partnering opportunities for our product candidates. In addition, past and current clinical trials, as well as compassionate use are not indicative and do not guarantee future success of our clinical trials. 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 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 afternoon is BiomX Chief Executive Officer, Jonathan Solomon to whom I will now turn over the call.

Thank you Marina and good afternoon everyone. We appreciate you taking the time to join BiomX quarterly update today. During the last quarter, the company advanced significantly, both across the corporate funds and with our clinical pipeline. Pivotal landmark events included in our March announcement of positive top line results from the company's phase 2 trial evaluating BX211 for the treatment of diabetic foot osteomyelitis or DFO associated with staphylococcus aureus. Also, during the first quarter, we announced a $12 million financing, which received the remaining shareholder approval in a special meeting last month. We expect the financing will provide a runway for us in the first quarter of 2026, aligned with the plan top line readout of the phase 2B study of BX004 in cystic fibrosis, which remains on track. I'll review our trial of BX211 in DFO first. DFO is an extremely challenging indication. No therapies have been approved in the United States for the treatment of DFO and as such, this disease represents a substantial unmet patient need. As background, each year there's a staggering number of approximately a 160,000 low limb amputations in diabetic patients in the U.S. alone, and the great majority, 85%, are estimated to be caused by either DFO or diabetic foot infections, DFI. The approximate direct cost for each amputation is $50,000, and the total financial burden on the U.S. healthcare system due to diabetic amputations is approximately $8 billion annually, a staggering figure. Sadly, DFO patients or patients with diabetic foot infections, or DFI, who have undergone amputations have a high 5-year mortality rates between 30% to 50%. This figure is worse than the 5-year survival of most cancers. Additionally, prior lower limb amputations is a major risk factor for subsequent amputations. We believe that the top line results of our phase 2 trial in DFO mark a potential turning point in how we can address this unmet need for patients. The press release, including results from the trial, can be found on our website. However, highlights from the phase 2 trial of BX211 include the following findings. We demonstrated safety and tolerability of BX211. In terms of activity, we saw with BX211 a sustained and statistically significant percent error reduction, or PER, ulcer size, with a separation from placebo starting at week 7, with a difference greater than 40% by week 10. There are also statistical significant improvement in ulcer death at week 13 in patients where ulcer death were defined as bone at baseline. And this p-value equals 0.048. We also saw significant statistical improvement with BX211 in reducing the expansion of ulcer area. This p-value equaled 0.017. We hosted a KOL event reviewing our top line results on April 3rd, and the link to the webcast can be found in this morning's press release. The KOL event itself received resounding endorsements 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 DFO. We are eager to share more of our subsequent analysis of the data at a scientific conference later this year. As for next steps, pending feedback from the FDA and additional regulatory agencies, we are planning a potential Phase 2-3 trial, and we are exploring potential funding and partnering opportunities for further advanced BX211 clinical development. The U.S. Defense Health Agency, DHA, has continued to support the development of BX211, and to-date, they have contributed approximately $40 million in non-diluted funding. The rise in antibiotic-resistant infections reported from ongoing global conflicts underscores the urgent need to protect combatants and non-combatants from antibiotic-resistant infections in current and potential future conflict environments. Bacteria phage therapy may offer a critical treatment option in these cases where antibiotics are no longer effective. Recently, in April, BiomX held a special meeting of shareholders, which approved the exercise of certain warrants issued as part of our $12 million financing that we announced this past February. The funds from the financing and warrant exercise are expected to ensure the continued development of the company's pipeline ahead of the results of a Phase 2b trial, evaluating BX004 as a treatment for cystic fibrosis, patients with chronic pulmonary infections associated with Pseudomonas aeruginosa. We'd like to take this opportunity to thank again Deerfield Management Company, the Cystic Fibrosis Foundation, Nathan Hala, and the additional investors that participated in the financing for their continued support of the company. Looking ahead, we remain confident in the strength of our clinical pipeline and our ability to advance the potentially life-changing therapeutics addressing high unmet needs in patients. The strength of the recent Phase 2 DFO readout further reinforces our approach and gives us strong momentum as we advance toward our next milestones, including our upcoming Cystic Fibrosis Trial readout, which remains on track to read out top-line results in the first quarter of 2026. I'd like now to pass you on to Marina to review our first quarter 2025 financial results.

Thank you, Jonathan. As a reminder, the financial information for the company's first quarter of 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 walk you through the highlights of the first quarter financial results. As of March 31, 2025, cash balance and restricted cash were $21.2 million, compared to $18 million as of December 31, 2024. The increase is primarily due to funds raised in our February 2025 financing, partially offset by net cash used in operating activities. BiomX estimates its cash, cash equivalents, and short-term deposits are sufficient to fund its operations into the first quarter of 2026. Research and development expenses met were $5.3 million for the first quarter of 2025, compared to $4.1 million for the first quarter of 2024. The increase was primarily due to the following factors. Preparations for the Phase 2b clinical trial of our CF product candidate, BX004, and increasing expenses relating to the Phase 2 clinical trial of our DFO product candidate, BX211, and an increase in rent and related expenses following the March 2024 acquisition of Adaptive Phage Therapeutics, or APT. The increase was partially offset by higher grants received. In the first quarter of 2025, general and administrative expenses were $2.5 million, compared to $2.7 million for the first quarter of 2024. The decrease is primarily attributed to expenses incurred during 2024 in connection with the APT acquisition, partially offset by increased salaries and share-based compensation expenses. Net loss was $7.7 million for the first quarter of 2025, compared to $17.3 million for the first quarter of 2024. The decrease is mainly due to the change in the fair value of the warrants issued as part of our March 2024 financing. Net cash used in operating activities for the three months ended March 31, 2025, was $8.7 million, compared to $11.4 million for the same period in 2024. Now I'll turn the call over to Jonathan for his closing remarks.

Thanks, Marina. This past quarter was a period of exceptional progress for BiomX, with major milestones for the company and our clinical programs. The top-line positive phase 2 results for BX211 and diabetic foot osteomyelitis, and our recent $12 million financing, together, further strengthen our position as we advance toward our next program catalyst for BX004 and cystic fibrosis. We are proud of the progress we have made in establishing the cure phase therapy as a potential treatment for resistant infection, and we appreciate the opportunity to share our momentum with you. Thanks again to all who joined the call this afternoon. And with that, we'd like to open it up to questions.

Ladies and gentlemen, thank you so much. We will now be conducting a question-and-answer session. [Operator Instructions] Our first questions come from the line of Joe Pantginis with H.C. Wainwright. Please proceed with your questions.

Hi, Jonathan and Marina. Thanks for taking the call and the questions. So, first, Jonathan, I wanted to ask about the DFO program, sort of a multi-part question. So, since you announced the data, how would you describe what's happening or with regard to regulatory consultants and your plan or timing for FDA interactions? That's number one. Number two, since, again, since the data, how have you streamlined your potential wish list for those regulatory interactions and anything you could share with us regarding thoughts on designs? And, again, what's the upcoming potential timing for any of these components?

Sure. So, Joe, always a pleasure connecting in a more civilized hour. So, apologies for changing as we were traveling. So, I think first few questions, just in terms of kind of planned regulatory interactions, I think what we're, again, right, this is still relatively hot off the press, very exciting data. I think we're fortunate to have already some of the top KOLs in the loop to begin with on the DFO study. And, obviously, an ongoing conversation with folks at the DHA because they're a crucial partner. And so, I think when we think about it, we're seeing basically a breakthrough win in DFO and targeting staff orders with phage, and that opens up multiple indications. I think specifically in DFOs, we think about next steps. We are gearing up to discuss with the regulatory agencies later this year. And, again, right, this is an option for breakthrough designation and orphan designation. So, there's quite a few exciting levers that we can pull. So, that's now in the works. And, hopefully, as we make progress, we can update. But I think also some of the dialogue that we're having because people are excited because things should be working in a great unmet need. And, of course, the Navy sort of eyeing wound care. But, basically, going after staff orders also opens up specific joint infections, some skin infections, right? So, there's a lot to think about. Again, we can't -- we don't want to bite more than we can chew. So, I think first we're focusing on the DFO program and potentially kind of looking at DFO DFI. Having these interactions with the FDA, talking to the partners. And, as we're in progress, kind of think about how we expand the program beyond that.

No, that sounds great. I appreciate that. And then maybe just a little more because you talked about the KOLs around the program. Again, since the data, can you talk about any further expansion beyond the lead KOLs on the data with regard to physician interest and, overall, an interest in participating in the next steps?

Quite a lot. I think it's also interesting to kind of, there's a few centers that have been running sort of diabetic foot, osteo and diabetic foot infections and compassionate use cases, right? It's kind of interesting to see U.S. sites on both coasts, European sites as well. So, we've been getting kind of incoming from all these different partners. So, I think we want to talk to them again. The next study is going to be global. So, I think these are going to be the partners as we think about the next steps for sure. And I think, and that's one of the things we've discussed. I think as we reflect and kind of digest the data and DFO, what's really interesting is that actually data and all these compassionate use cases actually has replicated, right. Stuff that we've seen, and remember all the conversations together, kind of, you look at a compassionate use data, it's really interesting, right. But you kind of be kind of, you know, you want to be cautious when you're analyzing the data because there's no proper control and all the limitations that we know. But if you think about it and take a step back, diabetic cardiovascular myelitis kind of stuck out as one of these indications that it seems to be working in a very high percentage, right. There's a paper from University of Washington. 11 out of 12 patients that were treated kind of prevented amputation. So, these are the numbers that we've seen. And I think we've seen the same thing in CF. So, I think all this experience of treating KOLs all over the world is going to be extremely valuable. And I think definitely people that we want to partner with.

Great. Thanks for the color, Jonathan.

You bet. Pleasure as always.

Thank you. Our next questions come from the line of Yale Jen with Laidlaw & Company. Please proceed with your questions.

Good afternoon. And this is a really faint hour for the call. I had to write it down. So, I appreciate the arrangement. My first question is that in terms of all four in CF phase 2, I understand that you're going to start and you will report an outcome in first quarter of next year. But could you provide a little bit more color in terms of when you might actually start a trial and any colors associated with that? And if anything impedes you from starting the trial or any sort of aiding factors, why not? And I have a follow-up question.

Sure. So, I think that study is on track. We do expect the data to be first quarter of 2026. Everything is looking good. I think we haven't, you know, we've been getting good response from the agency as well. So, we don't see anything impeding. Quite on the contrary. I think unlike some of the discussions we had and, you know, the difficulties we had in the early stage of recruiting the first studies in CF, here, because of the data that we showed in November 2023, the phase 2a, there's quite a lot of excitement. And centers already have patients lined up with physicians really eager to enroll them. So, we anticipate this to be on time, you know, so far so good. I think the CMC issues that we've had are behind us, all the materials ready. So, that's imminent.

Okay. Great. That's very helpful. And I understand that's a very important catalyst for the share as well. In terms of BX211, just two questions. First of all, based on the data you recently reported, which is quite outstanding, quite honestly. And do you anticipate you can directly go into COCO phase 3 or at least pivotal study? What's your thoughts? And a follow-up on that is that you mentioned that there will be a medical conference to present that. And then maybe I assume you will have publications. Any colors on that, on those fronts as well?

So, I think, again, there's obviously more analysis on the data and that's still in the works. To your point, we think there is a chance to pursue straight a pivotal study, given the fact that we know there's no treatment out there. The data from what we've seen looks very, very good. And we need to add, I think, the safety profile phase. We haven't seen adverse events. We want to confirm that this is a very safe agent. So, I think that opens up a lot of flexibility to try to move as fast as we can. Again, we cannot sort of commit that this is necessarily going to be a pivotal study, because to Joe's earlier question, we do want to talk to the agency and kind of think about the results and see if there's consideration that everything needs to kind of line up. But, yes, I think that's our intention. We do want to pursue it, again, pending all the confirmation from the agency.

In terms of application or medical conference, do you have any prospect at this point to contemplate with?

So, we're working on it. We'll discuss when it's formal. But I think we have such great people, such as, Professor Benjamin Lipsky and Dr. Chip Schooley. So, I think these have been kind of advocates that are sharing and wanting to present in all these conferences. So, we do anticipate. And, again, there's more data and more analysis. So, we are definitely working. We're excited about it. We'd also want to put everything in a publication, I think, given the quality of the data and the completeness, kind of the totality of the data. So, once we'll be there, we'll update on that.

And maybe last, squeeze me in one more question here, which is a more generic one, which is that phage therapy, obviously, is a newcomer to the space so everybody's learning. But, in your thoughts, whether that would be in the CF or in CFS or any other indication. What do you think the, and the phage is relatively safe as an agency is concerned, as you guys are concerned. So, what do you think the safety database, size of the safety database may be needed? In other words, sometimes even the trial study, trial size may be smaller, but there's a safety element of that. So, what's your thought in terms of the safety database size? How much do you expect, I should say?

Yeah, yeah. It's a great question. I think what we've seen historically is that, right, like in orphan indication, you want to get, like, an exposure of around 300 patients, right. But we know that there are cases that you can use less. Whether it's like ultra-orphan indications or cases that patient recruitment is very tough. So, I think what we're hoping is that we can go below that number just based on, again, we are targeting orphan indication. It is very selective given the fact that it's precision medicine. But I do hope, and again, that's to be discussed, but the vast safety of this product, right, will play into our capability of reducing the number of needed patients and accelerate the approval of the product.

Okay, great. Appreciate all the colors and congrats on the development. Maybe just one more question here.

Sure, yeah.

Sorry about that.

No problem.

In terms of cash, on the pro forma basis, should we add the $12 billion from the warrants to the 21? So, make it pro forma somewhere around $33 million. Was that the right number or that's not necessarily the case?

Yeah, I'll let Marina address that.

Okay, sure. Thank you for the question. So, if you mean the $12 million that we were phrased in February that is already incorporated in the $21 million on our balance sheet. But, of course, we also issued warrants, and as long as these are not exercised, yes, you can definitely add those, and that is another $12 million.

Okay, great. Thanks a lot. I really appreciate it.

Thank you for the kind words.

Thank you. We have reached the end of our question-and-answer session. I would now like to turn the floor back over to Jonathan Solomon for any closing comments.

So, I just wanted to thank everyone for listening to our call, taking the time, and supporting us through this path of taking phage forward and alleviating these unmet needs. I wanted to wish you all a pleasant rest of the day and a good afternoon. Thank you.

Thank you. This does include today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.