BiomX Q1 2025 Earnings Call Transcript

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May 15, 2025

There are 5 speakers on the call.

Operator

Greetings, and welcome to the BioMix First Quarter twenty twenty five Financial Results Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. Please note this conference is being recorded. I will now turn the conference over to Marina Wolfson, Chief Financial Officer.

Operator

Thank you. You may begin.

Speaker 1

Thank you, and welcome to the Bionics conference call to review the company's first quarter twenty twenty five 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 06:30 a. M. Eastern Time today and can be found on our website at biomics.com.

Speaker 1

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 provisions. All statements on this call that are not factual historic statements may be deemed forward looking statements. For instance, we are using forward looking statements when we discuss in 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 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.

Speaker 1

Except as 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 BioNTech's Chief Executive Officer, Jonathan Sullivan, to whom I will now turn over the call.

Speaker 2

Thank you, Marina, and good afternoon, everyone. We appreciate you taking the time to join BioMix quarterly update today. During the last quarter, the company advanced significantly, both across the corporate fund and with our clinical pipeline. Pivotal landmark events included in our March announcement of positive top line results from the company's Phase two trial evaluating BX211 for the treatment of diabetic foot osteomyelitis or DFO associated with Staphylococcus auris. Also during the first quarter, we announced a $12,000,000 financing which received the remaining shareholder approval in a special meeting last month.

Speaker 2

We expect the financing will provide a runway for us in the first quarter of twenty twenty six aligned with the planned 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 No therapeutics have been approved in The United States for the three hundred DFO and as such this disease represents a substantial unmet patient need. As background each year there's a staggering number of approximately one hundred and sixty thousand low limb amputations in diabetic patients in The U. S.

Speaker 2

Alone and the great majority eighty five percent are estimated to be caused by either EFO 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 $8,000,000,000 annually, a staggering figure. Sadly, VFO patients or patients with diabetic foot infections or DFI who have undergone amputations have a high five year mortality rates between thirty to fifty percent.

Speaker 2

This figure is worse than five 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 two trial in VFO market potential turning point in how we can address this unmet need for patients. The press release including results of the trial can be found on our website. However, highlights from the Phase two trial of BX211 include the following findings.

Speaker 2

We've demonstrated safety and tolerability of BX211. In terms of activity, we saw with BX211 a sustained and statistically significant percent error reduction or par ulcer size with a separation from placebo starting at week seven with a difference greater than 40% by week ten. There are also statistical significant improvement in also deaf at week thirteen in patients where altered deaf were defined as bone at baseline. And this P value equaled 0.048. We also saw significant statistical improvement with BX211 in reducing the expansion of ulcer area this p value equaled 0.017.

Speaker 2

We hosted a KOL event reviewing our top line results on April 3 and the link to the webcast can be found in this morning's press release. The KOL event itself received resounding endorsement from key opinion leaders, physician 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 the scientific conference later this year. As for next steps, pending feedback from the FDA and additional regulatory agencies, we are planning a potential Phase twothree trial and we are exploring potential funding and partnering opportunities to further advance BX211 clinical development. The U.

Speaker 2

S. Defense Health Agency DHA has continued to support the development of BX211 and to date they have contributed approximately $40,000,000 in non diluted funding. The rise in antibiotic resistant infections reported from ongoing global conflict underscores the urgent need to protect combatants and non combatants from antibiotic resistant infections in current and potential future conflict environments. Bifurophage therapy may offer a critical treatment option in these cases where antibiotics are no longer effective. Recently in April, Vionic held a special meeting of shareholders which approved the exercise of certain warrant issued as part of our $12,000,000 financing that we announced this past February.

Speaker 2

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 Salvation, Nathal Khala and the additional investors that participated in the financing for their continued support of the company. Looking ahead, we remain confident in the strength pipeline and our ability to advance the potentially life changing therapeutics addressing high unmet needs in patients. The strength of the recent Phase two 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 readout top line results in the first quarter of twenty twenty six. I'd like now to pass you on to Marina to review our first quarter twenty twenty five financial results.

Speaker 1

Thank you, Jonathan. As a reminder, the financial information for the company's first quarter of twenty twenty five 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 03/31/2025, cash balance and restricted cash were $21,200,000 compared to $18,000,000 as of 12/31/2024. The increase was primarily due to funds raised in our February 2025 financings, partially offset by net cash used in operating activities.

Speaker 1

Biomix estimates its cash, cash equivalents and short term deposits are sufficient to fund its operations into the first quarter of twenty twenty six. Research and development expenses net were $5,300,000 for the first quarter of twenty twenty five compared to $4,100,000 for the first quarter of twenty twenty four. The increase was primarily due to the following factors: preparations for the Phase 2b clinical trial of our CF product candidate VX004 and increase in expenses related to the Phase two clinical trial of our DFO product candidate VX211 and an increase in REN and related expenses following the March 2024 acquisition of Adaptive Stage Therapeutics or APT. The increase was partially offset by higher grants received. In the first quarter of twenty twenty five, general and administrative expenses were $2,500,000 compared to $2,700,000 for the first quarter of twenty twenty four.

Speaker 1

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 $7,700,000 for the first quarter of twenty twenty five compared to $17,300,000 for the first quarter of twenty twenty four. 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 03/31/2025 was 8,700,000 compared to $11,400,000 for the same period in 2024. Now I'll turn the call over to Jonathan for his closing remarks.

Speaker 2

Thanks Marina. This past quarter was a period of exceptional progress for Vionix with major milestones for the company and our clinical programs. The top line positive Phase two results for BX211 in diabetic foot osteomyelitis and our recent $12,000,000 financing together further strengthen our position as we advance toward our next program catalyst for BX004 in cystic fibrosis. We are proud of the progress we have made in establishing the CurePhase 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 up up to questions.

Operator

Ladies and gentlemen, thank you so much. We will now be conducting a question and answer session. Thank you. Our first questions come from the line of Joe Pantginis with H. C.

Operator

Wainwright. Please proceed with your questions.

Speaker 3

Hi, Jonathan and Marina. Thanks for taking 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.

Speaker 3

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?

Speaker 2

Sure. So Joe, always pleasure connecting in a more civilized hour. 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.

Speaker 2

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 crucial partner. And so I think when we think about it, we're seeing basically a breakthrough win in DFO and targeting staph aureus 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.

Speaker 2

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, we make progress, we can update. But I think also some of the dialogue that we're having because people are excited because things to be working in a great unmet need.

Speaker 2

And of course, the Navy sort of eyeing wound care, but basically going after Staph aureus 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. I think first we're focusing on the DFO program and potentially kind of looking at DFO, DSI, having these interactions with the FDA, talking to the partners and then as we make progress kind of think about how we expand the program beyond that.

Speaker 3

No, that sounds great. 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?

Speaker 2

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 capacity use cases, right? It's kind of interesting to see U. S. Sites on both coasts, European sites as well.

Speaker 2

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.

Speaker 2

I think as we reflect and kind of digest the data in DFO, what's really interesting is that actually data in 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 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 and take a step back, diabetic ketoacidosis 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, right?

Speaker 2

Eleven out of twelve 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.

Speaker 3

Great. Thanks for the color, Jonathan.

Speaker 2

You bet. Pleasure as always.

Operator

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

Speaker 4

Good afternoon. And this is a really faint hour for the call and the right now. So I appreciate the My first question is that in terms of four in CF Phase two, I understand that you're going to start a new reported 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? Is there anything impede you from starting the trial or any sort of gating factors or not?

Speaker 4

And I have a follow-up question. Sure.

Speaker 2

So I that study is on track. We do expect the data to be first quarter of twenty twenty six. Everything is looking good. I think we haven't we've been getting good response from the agency as well. So we don't see anything impeding.

Speaker 2

Quite on the contrary, I think unlike some of the discussions we had and 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. So far, so good. I think the CMC issues that we've had are behind us, all the materials ready.

Speaker 2

So that's imminent.

Speaker 4

Okay, great. That's very helpful. And I understand that's a very important catalyst for the For sure. For the share as well. In terms of VX-two two-two 11, just two questions.

Speaker 4

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 three or at least pivotal study? What's your thoughts? And the follow on that is that you mentioned that there will be medical conferences to present that and then maybe I assume you will be have publications. Any colors on that on those fronts as well?

Speaker 2

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, yes, we've discussed, right. 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 of FAITH, right?

Speaker 2

We haven't seen adverse events. The agency kind of confirms 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 is going to be a pivotal study, because to Joe's earlier question, we do want to talk to the agency, kind of think about the result of the CMC consideration that everything needs to kind of line up. But yes, I think that's our intention.

Speaker 2

We do want to pursue it again pending all the confirmation from the agency.

Speaker 4

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

Speaker 2

So we're working on it. We'll disclose one is formal, but I think we have such great people such as Professor Benjamin Lipsky and Doctor. Chip Schooley. So I think these have been kind of advocates and that are sharing and wanting to present in all these conferences. So we do anticipate and again there's more data and more analysis.

Speaker 2

So we are definitely working. We're excited about it. We'd also want to put everything in 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.

Speaker 4

And maybe last squeeze me in one more question here, which is a more generic one, which is that, Phase therapy obviously is a newcomer to the space. So everybody's learning. But in your thoughts, whether that will be in the CF or in CFFO or any other indications, what do you think the the phase is relatively safe as agency concern or you guys concern. So what do you think the safety database, size of the safety database may be needed in that or sometimes even the trial study trial size may be smaller, but there's a safety elements of that. So what's your thought in terms of the safety database size?

Speaker 4

Or how much do you expect

Speaker 2

to be? Yes, yes. 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? We know that there cases that you can use less, right, whether it's like ultra orphan indications or cases that patient recruitment is very tough.

Speaker 2

So I think what we're hoping is that we can go below that number just based on again, we are targeting orphan indication, right. 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 a capability of reducing the number of new patients and accelerate the approval of the product.

Speaker 4

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

Speaker 2

Sure, yes.

Speaker 4

Sorry about that.

Speaker 2

No problem.

Speaker 4

In of cash, on the pro form a basis, should we add the $12,000,000,000 from the warrants to the 2021, so make it pro form a somewhere around $33,000,000 Was that the right number or that's not necessarily be the case?

Speaker 2

Yes, I'll let Marina address that.

Speaker 1

Okay, sure. Thank you for the question. So if you mean the $12,000,000 that we were phrased in February, that is already incorporated in the $21,000,000 on our balance sheet. Of course, we also issued warrants. And as long as these are not exercised, yes, you can definitely add those and that is another $12,000,000

Speaker 4

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

Speaker 2

And was pleasure. Thank you for the kind words.

Operator

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

Speaker 2

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

Operator

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

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Earnings Conference Call
BiomX Q1 2025
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