Q1 2025 BiomX Inc Earnings Call
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Operator: Greetings and welcome to the Biomx first quarter 2025 financial results conference call. At this time, all participants are in a listen only mode.
Greetings and welcome to the Biologics first quarter 2025 financial results Conference call.
At this time all participants are in a listen only mode.
Operator: question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note, this conference is being recorded.
A question and answer session will follow the formal presentation.
I didn't want you require operator assistance during the conference. Please press star zero on your telephone keypad. Please.
Please note this conference is being recorded.
Operator: I will now turn the conference over to Marina Wolfson, Chief Financial Officer. Thank you. You may be.
I'll now turn the conference over to Marina Watson Chief Financial Officer. Thank you you may begin.
Marina Wolfson: 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 program. 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 630 a.m. Eastern Time today and can be found on our website at biomicstaff.org. A replay of this call will also be available in the investors section of our website.
Speaker Change: Thank you and welcome to the Bionics Conference call to review the company's first quarter 2025 financial results and provide an update on our business and programs.
Speaker Change: Later today, we will file our quarterly report on Form 10-Q, with the Securities and Exchange Commission.
Speaker Change: In addition to the press release became available at 630 am Eastern time today and can be found on our website at <unk> Dot com.
Speaker Change: A replay of this call will also be available in the investors section of our website.
Marina Wolfson: 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 boiler breaking 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.
Speaker Change: As we begin I'd like to review the Safe Harbor provision.
Speaker Change: Payments on this call that are not factual historic statements may be deemed forward looking statements.
Speaker Change: For instance, we're using forward looking statements when we discussed in the conference call. The sufficiency of the company's cash our pipeline the design recruitment and expected timing and interim and final results of our clinical trials.
Speaker Change: The discussions with the FDA and additional regulatory agency and results thereof.
Speaker Change: Potential benefits of our product candidates the potential safety or efficacy of our product candidates fix the Diablo four index to 11, and the potential markets and partnering opportunities for our product candidates.
Marina Wolfson: In addition, past and current clinical trials, as well as compassion reviews, 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. The full-fledged harbor provision, including risks that could cause actual results to differ from these forward-looking statements, are outlined in today's press release.
Speaker Change: In addition, past and current clinical trials as well as compassionate views are not indicative and do not guarantee future success of our clinical trials.
Speaker Change: Except as required by law, we do not undertake to update forward looking statements.
Speaker Change: 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.
Marina Wolfson: which as noted earlier is on our website.
Jonathan Solomon: 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 front and with our exotical pipeline.
Speaker Change: Joining me on the call. This afternoon is bionics, Chief Executive Officer, Jonathan Solomon to whom I will now turn over the call.
Jonathan Solomon: Thank you Marina and good afternoon, everyone. We appreciate you taking the time to join by almost quarterly update today.
Jonathan Solomon: During the last quarter the company advanced significantly both across the corporate funds and with our clinical pipeline.
Jonathan Solomon: Pivotal landmark events included in a 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 a planned top-line readout of the Phase 2B study of BX004 in cystic fibrosis, which remains on track.
Jonathan Solomon: It'll landmark events included in our March announcement of positive topline results from the companies Phase two trial evaluating D X 211 for the treatment of diabetic foot osteomyelitis or DSO associated with Staphylococcus aureus also during the first quarter, we announced a $12 million financing, which received the remaining shareholder approval.
Jonathan Solomon: So meeting last month.
Jonathan Solomon: We expect the financing will provide the runway for us in the first quarter of 2026 aligned with a planned top line readout of the phase <unk> study of <unk> four in cystic fibrosis, which remains on track.
Jonathan Solomon: I'll review our trial of BX211 in DFO first. DFO is an extremely challenging indication. No therapeutics have been approved in the United States for the treatment of DFO. And as such, this disease represents a substantial unmet patient. As background, each year there's a staggering number of approximately 160,000 lower 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.
Speaker Change: I'll review, our trial of <unk> 211, and DSO first DSO has been extremely challenging indication no therapeutics have been approved in the United States for the treatment of DSO and as such this disease represents a substantial unmet patient need.
Speaker Change: As background each year, there is a staggering number of approximately 160000, lower limb amputations and diabetic patients in the U S alone.
Speaker Change: And the great majority, 85%, our estimates would be caused by either yes, though the diabetic foot infections ESI.
Speaker Change: The approximate direct cost for each amputation is $50000 and the total financial burden on the U S health care system due to diabetic amputations is approximately $8 billion annually.
Speaker Change: Staggering figure.
Jonathan Solomon: Sadly, vehicle patients or patients with diabetic foot infections, or DFI, who have undergone amputations have a high five-year mortality rates between 30 to 50%. This figure is worse than the five-year survival of most cancers. Additionally, prior lower limb amputations is a major risk factor for subsequent amputation.
Speaker Change: Sadly <unk> patients or patients with diabetic foot infections or DSI was undergoing amputations have a five five year mortality rates between 30% to 50%.
Speaker Change: This figure is worse than the five year survival of most cancers. Additionally, prior lower limb amputations is a major risk factor for subsequent applications.
Jonathan Solomon: We believe that the top-line results of our Phase 2 trial in BFO mark a 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 2 trial of BX211 include the following findings. We demonstrate 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 7, with a difference greater than 40% by week. There are also statistical significant improvement in ulcer death at week 13 in patients where ulcer death were defined as bone at baseline.
Speaker Change: We believe that the topline results of our phase two trial in DSO market potential turning point and 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 one of the phase two trial of extra one one include the following five weeks.
Speaker Change: Demonstrated safety and Tolerability of <unk> to one one.
Speaker Change: In terms of activity, we saw would be extra one one a sustained and statistically significant percent area reduction or par also size with a separation from placebo starting at week seven with a difference greater than 40%.
Speaker Change: But there.
Speaker Change: There are also statistical significant improvement and I'll also death at week 13 in patients where ultras that were defined as bone at baseline and decent P value.
Jonathan Solomon: 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.
Speaker Change: <unk> 0.0, 48, we also saw significant statistical improvement would be X to one one.
Speaker Change: Reducing the expansion of ulcer area. This P value equal to 0.017.
Jonathan Solomon: 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 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.
Speaker Change: We hosted a KOL relevant reviewing our topline results on April 30, and the link to the webcast can be found in this morning's press release.
Speaker Change: All event itself received resounding endorsements 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 DSO.
Jonathan Solomon: We are eager to share more of our subsequent analysis of the data at a scientific conference later today.
Speaker Change: We're eager to share more of our subsequent analysis of the data at a scientific conference later this year.
Jonathan Solomon: 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.
Speaker Change: As for next steps pending feedback from the FDA and additional regulatory agencies. We are planning a potential phase two three trial and we are exploring potential funding and partnering opportunities that further advance speaks to one one's clinical development the.
Speaker Change: The U S Defense Health Agency D. J has continued to support the development of the extra one one and to date. They have contributed approximately $40 million in non dilutive funding there.
Jonathan Solomon: 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. Bacteriophage therapy may offer a critical treatment option in these cases where antibiotics are no longer effective.
Speaker Change: The rise in the antibiotic resistant infections reported from ongoing global conflicts underscores the urgent need to protect combatants and non-combatants than antibiotic resistant infections, and current and potential future conflicts environments.
Speaker Change: If each therapy may offer a critical treatment option in these cases, where antibiotics are no longer effective.
Jonathan Solomon: 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 IIb trial, evaluating BX004 as a treatment for cystic fibrosis patients with chronic pulmonary infections associated with pseudomonas aeruginosa.
Speaker Change: Recently in April, but it makes all the 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.
Speaker Change: Funds from the financing and warrant exercise or expected to ensure the continued development of the Companys pipeline and how did the results of the phase <unk> trial evaluating <unk> for the treatment for cystic fibrosis patients with chronic pulmonary infections associated let's see the most surgeon Nelson.
Jonathan Solomon: We'd like to take this opportunity to thank again Deerfield Management Company, the Cystic Fibrosis Foundation, Nathan Halla, and the additional investors that participated in the financing for their continued support of the. 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 II 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.
Speaker Change: We'd like to take this opportunity to thank again Deerfield management company. The cystic fibrosis Foundation knocked on how and the additional investors that participated in the financing for their continued support of the company.
Speaker Change: Looking ahead, we remain confident in the strength of our clinical pipeline and our ability to advance potentially life changing therapeutics addressing high unmet needs in patient the strength of the recent phase II D. S. O Readouts 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.
Speaker Change: To read out top line results in the first quarter of 2026.
Marina Wolfson: I'd like now to pass you on to Marina through your 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. I will now walk you through the highlights of the first quarter financial review. As of March 31st, 2025, cash balance and restricted cash were $21.2 million, compared to $18 million as of December 31st, 2025. The increase is primarily due to funds raised in our February 2025 financing, partially offset by net cash used in operating activities.
Speaker Change: I'd like now to pass you onto moving now to review our first quarter of 2045 financial results.
Jonathan Solomon: Thank you Jonathan How's It 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-K, which will be filed later today.
Speaker Change: I will now walk you through the highlights of the first quarter financial results.
Speaker Change: As of March 31st 2025, cash balance and restricted cash were $21 $2 million compared to $18 million as of December 31st 2024.
Speaker Change: The increase was primarily due to funds raised in our February 2025, financings, partially offset by net cash used in operating activities.
Marina Wolfson: Biomx estimates its cash, cash equivalents, and short-term deposits are sufficient to fund its operations into the first quarter of 2020. Research and development expenses net were $5.3 million for the first quarter of 2025, compared to $4.1 million for the first quarter of 2025. The increase is primarily due to the following factors. Preparations for the Phase 2b clinical trial of our CF product candidate, VX004. and increasing expenses related 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.
Speaker Change: I am ex estimates its cash cash equivalents and short term deposits are sufficient to fund its operations into the first quarter of 2026.
Speaker Change: Research and development expenses net were $5 $3 million for the first quarter of 2025 compared to $4 $1 million for the first quarter of 2024.
Speaker Change: The increase was primarily due to the following factors preparations for the phase <unk> clinical trial of our CF product candidate mixed it up a little for it.
Speaker Change: An increase in expenses related to the phase two clinical trial of I D. F O product candidate <unk> two a lot of Eddie and then increasing rent and related expenses. Following the mic trace any for acquisition of adaptive stage therapeutics or a P T.
Marina Wolfson: 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 2025. 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. 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 findings.
Speaker Change: The increase was partially offset by higher grants received.
Speaker Change: In the first quarter of 'twenty 'twenty, five general and administrative expenses were $2 $5 million compared to $2 $7 million for the first quarter of 2024.
Speaker Change: The decrease is primarily attributed to expenses incurred during 2024 in connection with the APC acquisition, partially offset by increased salaries and share based compensation expenses.
Speaker Change: Net loss was $7.7 million for the first quarter of 2025 compared to $17 $3 million for the first quarter of 2024.
Speaker Change: Decrease is mainly due to the change in the fair value of the warrants issued as part of our March 2020 for financing.
Marina Wolfson: Net cash used in operating activities for the three months ended March 31st, 2025, was $8.7 million compared to $11.4 million for the same period in 2025.
Speaker Change: Net cash used in operating activities for the three months ended March 31st 2025 was $8 $7 million compared to 11 $4 million for the same period in 2024.
Jonathan Solomon: 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 in diabetic osteomyelitis and our recent $12 million financing together further strengthen our position as we advance toward our next program catalyst for BX004 in cystic fibrosis.
Jonathan Solomon: Now I'll turn the call over to Jonathan for his closing remarks.
Speaker Change: Thanks Marina this past quarter was a period of exceptional progress or bionics with major milestones for the company and our clinical programs. The topline positive phase two results would be extra one one in diabetic foot ulcer in my life and a recent $12 million financing together further strengthen our position as we advance toward our next program catalysts for <unk> Oh for cystic fibrosis.
Jonathan Solomon: 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.
Speaker Change: We are proud of the progress we have made in establishing the pure phage therapy as a potential treatment for resistant infection and we appreciate the opportunity to share our momentum.
Operator: Thanks again to all who joined the call this afternoon, and with that, we'd like to open up up to questions. Ladies and gentlemen, thank you so much.
Speaker Change: Thanks, again to all who joined the call this afternoon and with that we'd like to open up to questions.
Speaker Change: Ladies and gentlemen, thank you so much.
Operator: will now be conducting a question. You would like to ask a question, please press star 1 on your telephone. Confirmation total indicate your line is in the question. You may press star two to remove your question.
We will now be conducting a question and answer session.
Speaker Change: You would like to ask a question. Please press star one on your telephone keypad.
Speaker Change: A confirmation tone will indicate your line is in the question queue.
Speaker Change: You May press star two to remove your question from the queue.
Operator: Participants using speaker equipment, it may be necessary to pick up your handset before pressing the start One moment, please, while we pull for your question. Thank you.
Speaker Change: Participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
One moment, please while we poll for your questions.
Joe Pantginis: Our first questions come from the line of Joe Pantginis with HC Wainwright. Please proceed with your question. 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, you know, what's happening or, you know, 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?
Speaker Change: Thank you our first questions come from the line of Joe Pan Janus with H C. Wainwright. Please proceed with your questions.
Speaker Change: Hi, Jonathan and Marina, Thanks for taking the call and the questions. So.
Speaker Change: So first Jonathan I wanted to ask about the D. F O programs sort of a multi part question. So since you announce the data.
Speaker Change: How would you describe you know what's happening or you know with regard to regulatory consultants in your plan or timing for FDA interactions. That's number one number two since again since the data how have you streamlined your potential wishlist for those regulatory interactions and anything you could share.
Speaker Change: With us regarding Fox on designs.
Joe Pantginis: And, you know, again, what's the upcoming potential timing for any of these components? Sure.
Speaker Change: And yeah again, what's the upcoming potential timing for any of these components.
Jonathan Solomon: 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 DFL study, and obviously an ongoing conversation with folks at DHA because they're a crucial partner. And so, I think when we think about it, we're seeing basically a breakthrough win in DFL in targeting staff orders with phage, and that opens up multiple indications.
Speaker Change: Sure So Joe Oh, it's pleasure connecting in a more civilized hour.
Speaker Change: I apologize for change it gets we were traveling and.
Speaker Change: So I think first of your question just in terms of kind.
Speaker Change: Kind of planned regulatory interactions I think what were they again right. This is still rapidly hot off the press very exciting data I think we're fortunate to have already some of the top kols.
Speaker Change: In the loop to begin with on on the <unk> study in.
Speaker Change: And obviously, an ongoing conversation with folks with the D. A J because they are a crucial partner and so I think when we think about it we're still seeing.
Speaker Change: Seeing basically a breakthrough win in D. F O I'm targeting staph aureus with phage and then opens up multiple indications I think specifically in DSO as we think about next steps we are gearing up to discuss with the regulatory system. Later this year and again right. This is an option for a breakthrough designation.
Jonathan Solomon: I think specifically in DFL as 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, you know, we can't, you know, we don't want to bite more than we can chew.
Speaker Change: And then the orphan designation, so theres quite a few exciting levers we can pull so that's now in the works and hopefully as we make progress we can update.
Speaker Change: Update, but I think also some of the dialogues that we're having because people are excited because it seems to be working in a great unmet need and of course, the navy sort of I.
Speaker Change: Our wound care, but basically going after staph aureus also opens up even a pathetic joint infections skin infections right. So there's a lot to think about it again, we can't you know we don't want to buy more than we can chew. So I think first we're focusing on the depot program and potentially kind of looking at DSO DSI, having these interaction with the FDA you're talking to the partner.
Joe Pantginis: So, 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 as we make 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, you know, 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 Change: And there's work progress kind of think about how we expand the program beyond that.
Speaker Change: 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 our physician interest and overall an interest in participating in the next steps.
Jonathan Solomon: quite a lot. I think it's also interesting to kind of, you know, 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.
Speaker Change: Quite a lot, but I think I think it's also interesting to kind of you know there's a few centers had been running sort of diabetic foot osteo and diabetic foot infections and compassionate use cases, right. It's kind of interesting to see your sights on both coasts European sites as well so we've been getting kind of incoming from all these different partners.
Speaker Change: So I think we wanted to talk to them again in 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 are.
Jonathan Solomon: 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, you know, 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.
Speaker Change: For sure and you know I think and that's one of the things we've discussed I think as we reflected in kind of digest the data and D. F. O. What's really interesting is that actually data and all these compassionate use cases actually has replicated right stuff that we've seen in and remember all accomplished together kind of if you look at our compassionate use data it's really interesting.
Speaker Change: Right, but you kind of be.
Speaker Change: You know you Wanna be I'm cautious when you analyze the data because there's no proper control and all the limitation that we know, but if you think about and take a step back.
Jonathan Solomon: 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, right? 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 KLLs all over the world is going to be, you know, extremely valuable. And I think, you know, definitely people that we want to partner with.
Speaker Change: I really quite honestly my life's kind of stuck out as one of these indications that it <unk> seem to be working at a very high percentage of their drive throughs with paper fun Wash 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 and so yes. So I think all of this experience of a treat and kols.
The world is going to be extremely valuable and I think you know definitely people that we want to partner with.
Joe Pantginis: Great. Thanks for the caller, Jonathan. You bet. Pleasure is all mine. Thank you.
Speaker Change: Great. Thanks for the color Jonathan.
Speaker Change: You bet pleasure as always.
Yale Gen: Our next questions come from the line of Yale Gen with Ley Law & Company. Please proceed with your question. Good afternoon, and this is a really safe hour for the call, and to write it down, so I appreciate the arrangement. My first question is that in terms of O4 and CF phase 2, I understand that you're going to 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? If anything impedes you from starting the trial or any sort of gating factors, why not?
Speaker Change: Thank you our next questions come from the line of Yale Jen with Laidlaw <unk> Company. Please proceed with your questions.
Yale Jen: Good afternoon.
Eight hours before the call Andrew arrived.
Yale Jen: Great.
Yale Jen: Management.
Yale Jen: My first question is that in terms of.
Uh huh.
Yale Jen: Oh, yes.
Yale Jen: Phase two I understand that you're going to start.
Yale Jen: Reported outcome.
Yale Jen: First quarter of next year, but could you provide more color in terms of when you might actually start to trial and any colors associated with that is there anything impede you from starting the trial or any sort of gating factors.
Yale Gen: 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's 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, you know, 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.
Yale Jen: Hello.
Yale Jen: Sure. So I think that study is on track, we do expect there to be first quarter of 'twenty fix everything is looking good I think we haven't you know we've been getting good response to the agency as well.
Yale Jen: So we don't see anything competing 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 it.
Yale Jen: The first studies in CF here because of the data that we showed in November of 2023 of the phase two a there's quite a lot of excitement and sensors already have patients lined up.
Yale Jen: 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.
Jonathan Solomon: 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.
Speaker Change: Okay, Great. That's very helpful and I understand that's a very important catalyst.
Yale Jen: For sure sure sure as well.
Yale Gen: In terms of VF211, 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?
Yale Jen: In terms of.
Yale Jen: <unk>.
Yale Jen: 211, just two questions first of all.
Yale Jen: Based on the data.
Yale Jen: As reported which is quite outstanding quite honestly and.
Yale Jen: Do you anticipate you can.
Yale Jen: Go into phase.
Yale Jen: It's three or these pivotal study what's the.
Jonathan Solomon: 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 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, you know, there is a chance to pursue straight a pivotal study, you know, given the fact that we know, you know, you know, there's no treatment out there. The data, you know, from what we've seen, looks very, very good. And we need to add, I think, the safety profile of faith, right?
Yale Jen: Thoughts and follow on that you said that you mentioned.
Yale Jen: There will be a medical conference to present that.
Yale Jen: And then maybe I assume you would be <unk> patients.
Yale Jen: Any.
Yale Jen: Colors on that no on those fronts as well.
Yale Jen: And so I think again, there's there's obviously more analysis on the data and that's that's still in the works to your point.
Yale Jen: We think you know there is there is a chance to pursue straight a pivotal study.
Speaker Change: Given the fact that we know Scott's right. There's no treatment is out there the data for what we have.
Speaker Change: She looks very very good and we need to add I think the safety profile of faith right. We haven't seen adverse events. The agency kind of confirms that this is a very safe agent and 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 there's going to be a little study cause.
Jonathan Solomon: 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.
Jonathan Solomon: 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 any 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.
Speaker Change: To Joe's earlier question, we do want to talk to the agency you kind of think about it because they sold it seems the consideration of about everything needs to kind of line up.
Speaker Change: But yes, I think that's a retention we do want to pursue it again pending all the confirmation from D. A.
Speaker Change: The agency.
Jonathan Solomon: 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, you know, I think we have such great people, such as, you know, 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. You know, 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.
Speaker Change: In terms of application or a medical Congress.
Speaker Change: No prospect of disciplined contemplate.
Speaker Change: So we're working on that well disclose the one its formal they you know I think we have such great people such as a you know a professor Benjamin let ski and Dr chips Cooley.
Speaker Change: So I think I think these have been kind of advocates and.
Speaker Change: Does that are are sharing and wanting to have presenting all of these conferences. So we do anticipate and again theres more data and more analysis. So we are definitely working we're excited about it you know we'd also want to put everything in a in a publication I think given the quality of the data and the completeness.
Speaker Change: Kind of the totality of the data so once once it will be there will we'll update on that.
Yale Gen: And maybe that sweeps 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, you know, the FFO or any other indications, what do you think the – and the phage is relatively safe as an agency concern or as you guys consider. 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 element of that.
Speaker Change: And maybe squeezing.
Speaker Change: And I'm sure a question here Mark.
Speaker Change: A more generic one which is that.
Speaker Change: Stage therapy, obviously is the newcomer to the to the space. So.
Speaker Change: Everybody is learning right.
Speaker Change: And your thoughts.
Speaker Change: Yeah.
Speaker Change: Sure.
Speaker Change: The event or any other indications one of the thing.
Speaker Change: They just really relatively safe.
Speaker Change: Considering all of this in a few days. So what do you think that safety database size of the safety database may be needed in that or sometime even to trial study trial size may be smaller, but theres no fee.
Speaker Change: Safety elements. So what's your thought in terms of the safety database size.
Yale Gen: So what's your thought in terms of the safety database size?
Yale Gen: Thank you.
Jonathan Solomon: Bye. 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, right, 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, right? It is very selective given the fact that it's precision medicine. But I do hope, and again, that 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.
Speaker Change: How much.
Speaker Change: You say yeah. It's a great question I think I think what we've seen historically is that right like an orphan indication.
Speaker Change: Wanted to get like an exposure of around 300 patients right, but we know that there.
Speaker Change: Is that you can use less right, whether it's an ultra orphan indications where cases that patient recruitment is very tough.
Speaker Change: 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 precision medicine.
Speaker Change: But I do hope and again, that's that has to be discussed, but the vast safety of this product right will play into a kid really reducing the number of new patients and accelerated approval of the product.
Yale Gen: Okay, great. Appreciate all the colors and congrats on the... development. In terms of cash, should we add the $12 billion? from the Warrens to the 21, so make it perform somewhere around $33 million. Was that the right number or that's not necessarily be the case? Yeah, I'll let Marina address that.
Speaker Change: Okay great.
Speaker Change: I appreciate the color and congrats on the.
Speaker Change: Thank you Elena maybe let me just one more question here.
Speaker Change: Sure Yeah, sorry about that.
Speaker Change: No problem.
Speaker Change: In terms of cash.
Speaker Change: Pro forma basis.
Speaker Change: Should we add 12 million.
Speaker Change: From the warrants to the 'twenty, one will make us pro forma somewhere around 33 million was that the right number or not.
Speaker Change: Yeah, I'll, let I'll, let marina our address that.
Marina Wolfson: Okay, sure. Thank you for the question. So, if you mean the $12 million that we 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.
Speaker Change: Okay sure. Thank you for the question.
Speaker Change: In the trial.
Speaker Change: That will fade in February that is all.
Speaker Change: That is already incorporated in that $21 million on our balance sheets, but of course, we also issue boy.
Speaker Change: As long as these are not exercised we will connect the happy to add those and that is another topic.
Yale Gen: Okay, great. Thanks a lot. I really appreciate it. Thank you for the kind words.
Speaker Change: Okay, great. Thanks, a lot I really appreciate it.
Speaker Change: Yeah.
Speaker Change: Thank you for the kind words.
Operator: Thank you.
Operator: We have reached the end of our question and answer session.
Speaker Change: 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 Sullivan for any closing comments.
Jonathan Solomon: I would now like to turn the floor back over to Jonathan Solomon for. 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 want to wish you all a pleasant rest of the day and a good afternoon. 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.
Speaker Change: So I just wanted to thank everyone for listening to our call taking the time and supporting us through this soft.
Speaker Change: Past a ticking fee.
Speaker Change: Page.
Speaker Change: Forward and alleviating these unmet needs I want to wish you all a pleasant rest of the day and a good afternoon. Thank you.
Speaker Change: Thank you. This does conclude today's teleconference. We appreciate your participation you may disconnect. Your lines at this time enjoy the rest of your day.
Speaker Change: [music].