Q4 2023 BiomX Inc Earnings Call
Operator: Good morning and welcome to the Biomx full year 2023 financial results and corporate update conference call. Currently, all participants are in a listen-only mode. There will be a question and answer session at the end of this call. I'd now like to turn the conference over to Avi Gabay, Interim Chief Financial Officer of Biomx. Avi, please proceed, sir.
Good morning, and welcome to the by almost a full year 2023 financial results and corporate update conference call. Currently all participants are in a listen only mode.
There'll be a question and answer session at the end of this call.
Now I'd like to turn the conference over to Avi Goodbye interim Chief financial officer of biomass.
Avi Goodbye: Please proceed sir.
Avi Gabay: Thank you and welcome to the Biomx full year 2023 financial results and corporate update conference call. The news release became available just after 6 a.m Eastern time today and can be found on our website at www.biomx.com. A replay of this call will also be available in the investor section of our website.
Avi Goodbye: Thank you and welcome to the bio mix full year 2023 financial results and corporate update conference call.
Avi Goodbye: Here's release became available just after 630, a M eastern time today.
Avi Goodbye: Can be found in our website at www dot.
Avi Goodbye: Dot com.
Avi Goodbye: A replay of this call will also be available in the investors section for our website.
Avi Gabay: Before 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 are using forward-looking statements when we discuss on the conference call the sufficiency of the combined company's financing, potential stockholders' approval of certain matters related to the securities issues and related matters in connection with the adaptive phage therapeutics or APT acquisition, potential market opportunities, the ability to drive value for stockholders, the design, aim, expected timing, and interim and final results of our preclinical and clinical trials, the regulatory process and discussion with the FDA, the potential benefits and commercial opportunities for product candidates, and the potential safety or efficacy of BX004 and BX211.
None: Before we begin I'd like to review the Safe Harbor provision.
None: All statements on this call are not factual historic statements may be deemed forward looking statements.
None: For instance, we are using forward looking statements when we discussed on the conference call. The sufficiency of the combined company's financing potential stockholders' approval of certain matters related to the securities issue and related matters in connection with the adaptive Sage therapeutics or a P T acquisition.
None: Potential market opportunities the ability to drive value for stockholders the design.
None: <unk> expected timing and interim and final results of our preclinical and clinical trials.
None: Gold Tory process and discussion with the FDA.
None: Essential benefits and commercial opportunities for our product candidates and the potential safety or efficacy of <unk> four and <unk> 211.
None: In addition, past and current preclinical and clinical results as well as compassionate use are not indicative and do not guarantee future success of our clinical trials.
Avi Gabay: In addition, past and current preclinical and clinical results, as well as compassion charges 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 provision, including risks that could cause actual results to defer 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 Jonathan Solomon, Chief Executive Officer of Biomx. With that, I will turn the call over to Jonathan.
None: Except as required by law, we do not undertake to update forward looking statements.
None: 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 these on our website jointly.
None: Joining me on the Cold. This morning is Jonathan Sullivan, Chief Executive Officer of Bionics.
Jonathan Eitan Solomon: With that I will turn the call over to Jonathan.
Jonathan Eitan Solomon: Morning, everyone. The fourth quarter of 2023 proved to be one of the most significant and exciting periods for our company, highlighted by the positive results from Part 2 of our Phase 1 B2A study of BX004. Soon after achieving these major clinical milestones, we announced the transformational acquisition of APT in March, adding to our pipeline a second Phase II product candidate, BX211, for the treatment of diabetic foot osteomyelitis. In connection with this acquisition, we also raised $50 million in a private placement led by affiliates of Deerfield Management's AMR Active Fund with the participation of additional existing and new investors, including the Cystic Fibrosis We deeply value and appreciate the support from these widely respected institutional investors.
Jonathan Eitan Solomon: Everyone.
Jonathan Eitan Solomon: The fourth quarter of 2023 proved to be one of the most significant and exciting periods ever company highlighted by the positive results from part two of our phase one b to a study would be acceptable for.
Jonathan Eitan Solomon: Soon after achieving this major clinical milestones, we announced the transformational acquisition of a P. T in March adding to our pipeline our second phase two product candidate be X to one one for the treatment of diabetic foot osteomyelitis.
Jonathan Eitan Solomon: In connection with this acquisition, we also raised $50 million in a private placement led by affiliates of Deerfield management EMR active fun with the participation of additional existing and new investors, including the secret Best Foundation or be made and not in all our capital.
Jonathan Eitan Solomon: We deeply value and appreciate the support from these widely respected institutional investors.
Jonathan Eitan Solomon: Including net proceeds from the financing in our existing capital, Biomx now expects to have sufficient funding to reach multiple clinical milestones over the next two years, including expected data readouts for BX211 and BX004 in the first quarter of 2025 and third quarter of 2025, respectively. With approximately 80 compassionate use cases, multiple clinical studies, and INDs, the combined company possesses an extraordinary depth of clinical experience in developing phage products, along with the expertise in regulatory FERS to help further advance these programs into pivotal testing. The acquisition created a leading phage company with one of the most advanced pipelines of phage-based therapeutics, which includes two clinical phage products, each having the potential to advance the standard of care in the respective disease areas. As noted, the combined company has two significant Phase 2 readouts anticipated in 2025, which, if successful, could potentially drive significant value for stockholders.
Jonathan Eitan Solomon: Net proceeds from the financing and our existing capital dynamics now expects to have sufficient funding to reach multiple clinical milestones over the next two years, including expected data readouts for <unk> to one one and be acceptable for in the first quarter of 2025 and third quarter of 2025, respectively.
Jonathan Eitan Solomon: With approximately 80 compassionate use cases multiple clinical studies, a ninety's the combined company possesses and explore any deaths of clinical experience in developing sage products.
Jonathan Eitan Solomon: Along with the expertise and regulatory affairs to help further advance these programs into pivotal testing.
Jonathan Eitan Solomon: The acquisition created a leading phage company with one of the most advanced pipelines of phage based therapeutics, which includes two clinical stage products each having the potential to advance the standard of care in their respective disease area.
Jonathan Eitan Solomon: As noted the combined company has two significant phase two readouts anticipated in 2025, which if successful could potentially drive significant value for stockholders.
Jonathan Eitan Solomon: I would like to spend more time today focusing on our new program in diabetic foot osteomyelitis, or DFL, in our ongoing Phase II clinical study. The study has already surpassed 70% of its target enrollment, and we remain on track to report Week 13 treatment results in the first quarter of 2025. Ulcers in patients with diabetes are a complication caused by a combination of poor blood circulation, susceptibility to infection, and nerve damage from high blood sugar levels. When there is limited blood flow to the wounded area, the body struggles to heal its wounds. So these wounds develop into diabetic ulcers. Once an infected ulcer deepens to the extent that it spreads into the bone, the condition is classified as DFO, which is a very serious condition that could lead to lower limb amputation.
Jonathan Eitan Solomon: I would like to spend more time today, focusing on our new program in diabetic foot osteomyelitis or D F L and our ongoing phase II clinical study.
Jonathan Eitan Solomon: The study has already surpassed 70% of our targeted enrollment and we remain on track to report the week 13 treating our results in the first quarter of 2025.
Jonathan Eitan Solomon: Also as in patients with diabetes or a complication caused by a combination of poor blood circulation susceptibility to infection and nerve damage from high blood sugar levels.
Jonathan Eitan Solomon: There's limited blood flow to the wounded area the body struggles to helix. Once so these wounds develop into diabetic ulcers. Once infected also deepens did they accept that as spreads into the bone the conditions classified as DSO, which is a very serious condition that could lead to lower limb amputation.
Jonathan Eitan Solomon: DFO standard of care often includes offloading of pressure from the foot, debridement, surgery, and up to a six-week course of topical oral or IV antibiotic therapy. Unfortunately, 30-40% of DFL cases fail, leading to amputation. Depending upon the location of the infected bone, amputations often result in the loss of a toe or, in more severe cases, the loss of a limb below or above the ankle, with a staggering number of approximately 160,000 lower limb amputations in diabetic patients in the U.S. alone, 85% of which are caused by DFO. According to the Center of Disease Control and Literature, this remains an area of high unmet need.
Jonathan Eitan Solomon: Do you feel the standard of care often includes offloading of pressure from the foot to Brighton surgery and up to six week course of topical or oral or IV antibiotic therapy.
Jonathan Eitan Solomon: Unfortunately, 30% to 40% of D. F O cases failed beatings amputations, depending upon the location of the infected Dawn amputations, often result in the loss of a toe or in more severe cases, the loss of a limb below or above the ankle.
Jonathan Eitan Solomon: With a staggering number of approximately 160000, lower limb amputations and diabetic patients annually in the U S alone, 85% of which are caused by D. F O. According to the center of disease control and literature. This remains an area of high unmet need.
One of the main reasons for the limited effectiveness of antibody therapy is poor delivery as a therapy to the infected zone.
Jonathan Eitan Solomon: One of the main reasons for the limited effectiveness of antibiotic therapy is poor delivery of the therapy to the infected bone. Biofilm, a polysaccharide mesh secreted by bacteria infecting the bone and ulcer, creates a barrier that inhibits antibiotic penetration in these patients who already suffer from poor blood circulation. Beyond delivery, antibiotic resistance is an additional contributing factor to the limited effectiveness of antibiotic treatment. For example, according to literature, approximately 40% of staphylococcus aureus infections are MRSA, a methylene-resistant form of staphylococcus aureus.
Jonathan Eitan Solomon: L. A polysaccharide mashed accretive buybacks, you're infecting the bone and also creates a barrier there inhibits antibiotic penetration in these patients who already suffer from poor blood circulation.
Jonathan Eitan Solomon: Beyond delivery antibiotic resistance is an additional contributing factor to the limited effectiveness of antibiotic treatment.
Jonathan Eitan Solomon: For example, according to literature, approximately 40% of Staphylococcus aureus infections are MSA methylene resistant Staphylococcus aureus.
Jonathan Eitan Solomon: Phage therapy has the potential to address these key drivers for treatment failure. When properly selected, phages effectively target and kill antibiotic-resistant bacterial strains and have the capacity to break down biofibers. For example, phages selected for the treatment of patients under our current DFO study were found when sequenced with multiple domains of catalytic activity against staphylococcal biofilm components. Moreover, a main factor that supports phage risk therapeutic approach to improve treatment outcomes in DFO is the positive results from numerous compassionate cases using phage therapy. Out of 12 cases reported in SACCHIC literature, 11 resulted in a positive outcome of wound healing and avoiding amputation.
Jonathan Eitan Solomon: Phage therapy has the potential to address these key drivers for treatment failure when properly selected phage effectively target and kill antibiotic resistant bacterial strains and have the capacity to break down by phone.
Jonathan Eitan Solomon: For example, faithful were selected for the treatment of patients under our current DFS study were found when sequence to have multiple domains of catalytic activity again staphylococcal biofilm components. Moreover, a main factor the supports phaedrus therapeutic approach to improve treatment outcomes in DSO are the positive results from numerous compassionate cases use.
Jonathan Eitan Solomon: <unk> phage therapy out of 12 cases reported in fact like literature 11 resulted in positive outcome of wound healing and avoiding amputation.
Jonathan Eitan Solomon: PX211, developed under APT's technology platform, is based on a personalized approach that utilizes one of the largest phage banks in the world to optimally pair individualized phage therapy to the specific strains of bacteria as biopsied from the patient. The treatment targets staphylococcus aureus, which is considered the most common bacterial infection in DFO, compromising approximately 50% of cases and is considered the most pathogenic bacteria due to its rapid doubling time and an arsenal of virulence factors. We estimate that BX211 represents a commercial opportunity of a billion dollars in the U.S. and over two billion dollars worldwide.
Jonathan Eitan Solomon: PX 211 developed under a P to use technology platform is based on personalized approach, which utilizes one of our largest states banks in the world to optimally pair individualized phage therapy to the specific strains of bacteria is biopsy from the patient.
Jonathan Eitan Solomon: Treatment targets Staphylococcus aureus, which is considered the most common bacterial infection in DSO compromising approximately 50% of cases and is considered the most pathogenic bacteria due to its rapid doubling time, an arsenal of violence factors, we estimate that the extra one one represents a commercial opportunity of $1 billion in the U S.
Jonathan Eitan Solomon: Over $2 billion worldwide.
Jonathan Eitan Solomon: We are now conducting a randomized double blind placebo controlled multicenter phase II study.
Jonathan Eitan Solomon: We are now conducting a randomized, double-blind, placebo-controlled, multi-center Phase 2 study investigating the safety, tolerability, and efficacy of BX211 in subjects with DFO associated with staph aureus. Approximately 45 subjects are planned to be randomized at a 2 to 1 ratio to BX211 or placebo. BX211 or Placido is administered weekly by topical and IV rat at week 1 and by the topical rat only at each of weeks 2 to 12. Throughout the 12-week period, all subjects continue to be treated in accordance with the standard of care, which includes antibiotic treatment as appropriate.
Jonathan Eitan Solomon: Investigating the safety Tolerability and efficacy of <unk> to one one in subjects with D. S L associated with staff for it.
Jonathan Eitan Solomon: Approximately 45 subjects are planned to be randomized at a two to one ratio to be X 211 or placebo.
Jonathan Eitan Solomon: 211, or placebo is administered weekly by topical and I V Rod at week, one and by the topic around only and each of weeks two to 12.
Jonathan Eitan Solomon: Over the 12 week period, all subject continues to be treated in accordance with the standard of care, which includes antibiotic treatment as appropriate.
Avi Gabay: As of now, we have enrolled 32 patients in the study, which amounts to over 70% of the target enrollment, and we are on-track to report results at week 13, a diary of wound healing associated with osteomyelitis, in the first quarter of 2025. We then expect to report a second readout in the first quarter of 2026, which is planned to evaluate amputation rates and resolution of osteomyelitis based on X-ray clinical assessment and established biomarkers such as ESR and CRP at week 15. With respect to the cystic fibrosis, or CF, program, in the second quarter of 2024, we expect to hold a type C meeting with the FDA to discuss our clinical development Assuming alignment with the FDA and the completion of our CMC work, we intend to submit a protocol to all relevant regulatory authorities and, following approval, begin patient enrollment in the Phase 2B study. As already noted, we estimate releasing top-line results from this study in the third quarter of 2025. And now I'll pass it over to Avi to review our fourth quarter and full year 2023 financial results.
Jonathan Eitan Solomon: As of now we have enrolled 32 patients in the study which amounts to over 70% of a targeted enrollment and are on track to report results at week 13, valuing healing of the wound associated with osteoarthritis in the first quarter of 2025.
Jonathan Eitan Solomon: We then expect to report a second read out in the first quarter of 2026, which is planned to evaluate amputation rates and resolution of osteomyelitis based on X Ray clinical assessment and established Biomarkers, such as ESR and CRP at week 52.
Jonathan Eitan Solomon: With respect to a cystic fibrosis or CF program in the second quarter of 'twenty 'twenty four we expect to hold a type C meeting with the FDA to discuss our clinical development plan for EXL below four.
Jonathan Eitan Solomon: Assuming alignment with the F D a and the completion of our CMC work when you tend to submit a protocol to all relevant regulatory authorities and following approval begin patient enrollment in phase <unk> study.
Already noted we estimate releasing topline results from this study in the third quarter 2025.
Jonathan Eitan Solomon: And now I'll pass it over to Avi to review, our fourth quarter and full year 2023 financial results.
Avi Goodbye: Thank you Jonathan.
Avi Gabay: Thank you, Jonathan. As a reminder, the financial information is available in the press release we issued earlier today and also in more detail in our Form 10-K, which will be filed later today. I will walk you through some of our brief highlights.
Avi Goodbye: As a reminder, the financial information is available in the press release, we issued earlier today and also in more detail in our Form 10-K, which will be filed later today.
Avi Goodbye: I will walk you through some of our brief highlights.
Avi Gabay: As of December 31st, 2023, the cash balance and short-term deposit were $15.9 million compared to $34.3 million as of December 31st, 2022. The decrease was primarily due to net cash used in operating activities. In 2023, our R&D expenses net were $16.7 million compared to $16.2 million in the previous year, mainly because of increased expenses related to the CF clinical trial that was partially offset by reduced salaries and related expenses and stock-based compensation expenses, as well as pausing in the development of the atopic dermatitis clinical trial. In addition, we increased consideration from research collaboration, which resulted in reduced R&D expenses.
Avi Goodbye: As of December 31, 2023, cash balance and short term deposits were $15 $9 million compared to $34 $3 million as of December 31, 2022.
Avi Goodbye: The decrease was primarily due to net cash used in operating activities.
Avi Goodbye: In 2023, our R&D expenses net were $16 $7 million compared to $16 $2 million in the previous year.
Avi Goodbye: Mainly because of increased expenses related to the C. S. Clinical trial. This was partially offset by reduced salaries and related expenses and stock based compensation expenses as well as pausing in the development of the atopic dermatitis clinical trial.
Avi Goodbye: In addition increased consideration from research collaboration which resulted in reduced R&D expenses.
Avi Goodbye: General and administrative expenses were $8 $7 million for 2023 compared to $9 $5 million for the prior year. The decrease was primarily due to a decrease in the company's directors and officer insurance premium.
Jonathan Eitan Solomon: General and administrative expenses were $8.7 million for 2023 compared to $9.5 million for the prior year. The decrease was primarily due to a decrease in the companies' directors and officer insurance. Net loss for 2023 was $26.2 million compared to $28.3 million for the prior year. Net cash used in operating activities for 2023 was $21.3 million, compared to $29.1 million for the same period in 2022. On March 15, 2024, we closed the acquisition of APT, concurrent with an investment of $15 million. Subsequent to this financing, we have fully repaid the remaining balance of approximately $10.4 million under the Hercules Loan Agreement. We would like to emphasize that although, after the financing, we have sufficient cash, cash equivalents, and short-term deposits to fund our current operating plan for at least the next 12 months, our financial statements contain an explanatory paragraph regarding substantial doubt about our ability to continue as going concerns. This is mainly due to the potential risk of our stockholders not approving the conversion of the convertible preferred stock that was at issue as part of the acquisition of APT and the concurrent investment. Now, I'll turn the call back over to Jonathan for his closing remarks. Jonathan
Net loss for 2023 was $26 $2 million compared to $28 $3 million for the prior year.
Avi Goodbye: Net cash used in operating activities for 2023 was $21 $3 million compared to $29 $1 million for the same periods in 2022.
Avi Goodbye: On March 15, 2024, we closed the acquisition of a P T concurrent with an investment of $15 million.
Avi Goodbye: Subsequent to this financing we fully repaid the remaining balance of approximately $10 $4 million under the Hercules loan agreement.
Avi Goodbye: Would like to emphasize that although after the financing with sufficient cash cash equivalent and short term deposits to fund our current operating plan for at least the next 12 months or so.
Avi Goodbye: Financial statements contain an explanatory paragraph regarding substantial doubt about our ability to continue as going concern.
Avi Goodbye: This is mainly due to the potential risk of our stockholders not approving the conversion of the convertible preferred stock that's where it issue as part of the acquisition of a P T and the concurrent investment.
Avi Goodbye: And now I'll turn the call back over to Jonathan for his closing remark Jonathan.
Jonathan Eitan Solomon: Thank you Avi.
Operator: Thank you, Avi. 2024 is shaping up to be a big year for Biomx. With the completion of the APT acquisition and the $50 million investment from top institutional healthcare investors, our company is well positioned to build significant value for stockholders as we continue advancing the BX004 and BX211 clinical programs. BX004 has already demonstrated safety and proof-of-concept efficacy in our Phase I B2A study. We look forward to reporting data on both BX004 and BX211 in 2025. We have also added additional scientific and business leadership to our board of directors that will play an important role in helping guide our clinical development efforts and interaction with regulatory authorities, while also helping us optimize our capital resources. Thank you again for joining us this morning, and we look forward to providing you with updates throughout the year.
Jonathan Eitan Solomon: 'twenty 'twenty four is shaping up to be a substantially or for bionics with the completion of the a P. T acquisition and a $50 million investment in top institutional health care investors. Our company is well positioned to build significant value for our stockholders as we continue advancing to be acceptable for mdx to one one clinical programs.
The Accel before has already demonstrated safety and proof of concept efficacy in a phase one b to a study and we look forward to reporting data on both be accept both for and be X to one one in 2025.
Jonathan Eitan Solomon: We have also added additional scientific and business leadership to our board of directors don't will play an important role in helping guide our clinical development efforts and interaction with the regulatory authorities, while also helping us optimize our capital resources.
None: Thank you again for joining us this morning, and we look forward to providing you with updates throughout the year.
None: Thank you, we'll now be conducting a question answer session, if you'd like to be placed in the question queue. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if you'd like to move your question from a Q1 moment. Please while we poll for questions.
Operator: Thank you, and now we'll be conducting a question and answer session. If you'd like to be placed in the question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. One moment, please, while we poll for questions. Our first question is from Joseph Pantginis from H.C. Wainwright. Your line is now active.
None: Our first question is coming from Joe Pangilinan from H C. Wainwright your line is that life.
Joseph Pantginis: Hi, everybody. Good morning, good afternoon, and thanks for taking the questions.
Joseph Pantginis: Hi everybody. Good morning. Good afternoon. Thanks for taking the questions. So first, Jonathan, I just want to get the update since the merger. What is the process looking like with regard to outstanding efficiencies and what might still be outstanding of note?
Joseph Pantginis: So first Jonathan I, just wanted to get the update since the the merger you know what is the how is the process looking with regard to outstanding you know efficiencies and what might still be outstanding of note.
Jonathan Eitan Solomon: So, good morning, Joe. Great question.
Jonathan Eitan Solomon: I think, you know, things are now moving. As we go through the process, we're often in Gettysburg now, and we're quite impressed with the team and the work that APT is doing. Of course, this is a process that will take a while, and we're actively kind of evaluating redundancies. There will be some, and, you know, it will take us a while to kind of finalize all the specific plans going forward.
Joseph Pantginis: Yeah.
Jonathan Eitan Solomon: Good morning, Joe Great question, I think you know things are now and moving them as we go through the process. We're often in gaithersburg now and were quite impressive.
Jonathan Eitan Solomon: With the team and the work that he is doing of course. This is a process that will take a while and we're actively are kind of evaluating redundancy. There will be some and you know it will take us a while to kind of finalize the all the.
Vic plans going forward.
Joseph Pantginis: Understood and and then if I could just I appreciate all the added details you provided today on DFO So I just just to dive into the weeds a little bit. So one of the things I've been thinking, you know when you look at You know for DFO itself, you know to me. There's a lot of reminiscent characteristics of say critical in ischemia and One of the things I guess I would associate with that is obviously amputation rate is the key endpoint here just like critical in ischemia and You know, there are a lot of aggressive physicians out there to try to be I'll almost go so far as to say cowboys You know to try to prevent amputations where it might be necessary So I guess the curiosity on my end is you know different aggressive physician techniques or say maybe lack of standards potentially How does that impact what might be considered a placebo impact or placebo effect on this study?
None: Understood and then if I could just.
None: <unk> all the added details you provided today on D. F O. So I just just to dive into the weeds, a little bit. So one of the things I've been thinking you know when you look at you know for D. F. O itself you know to me, there's a lot of reminiscent characteristics of say critical limb ischemia and one of the things I guess I would associate with that is.
None: Obviously amputation rate is a key endpoint here just like critical limb ischemia.
None: And you know there are a lot of aggressive physicians out there to try to be all almost go so far as to say Cowboys, you know to try to prevent amputations, where it might be necessary. So I guess the curiosity on my end is you know different aggressive physician techniques or say, maybe lack of standards potentially.
How does that impact what might be considered a placebo impact or a placebo effect on this study.
None: So you're spot on I think you know application is it is a much more complicated endpoint and I think that's what we look at it as a more exploratory well.
Jonathan Eitan Solomon: So you're spot on. I think amputation is a much more complicated endpoint, and I think that's what we look at as a more exploratory. We'll look at all of that. But I think in this study, we're looking at a shorter time frame and focusing on the ulcer, potential shrinkage, and maybe healing in some of these patients. I do agree that amputation is tougher.
None: We will look at all to that I think in this study we're looking at a shorter time frame and focusing on the author on the ulcer Hum potential shrinkage in maybe healing if some of these patients.
None: I do agree that amputation is tougher there is an ongoing research and body of work I'm trying to look into.
Jonathan Eitan Solomon: There is an ongoing research and body of work trying to look into additional surrogate endpoints, such as looking at the x-ray and some other endpoints. So that might give us a better sense of the healing process in a shorter time frame. There are also some KOLs advocating looking at an even shorter time frame than the 12 weeks we're looking at. So I think we'll see all of that. Again, in this study, we're looking at a shorter time point and way before all the amputations kick in. We'll obviously follow the patients for a longer period of time. We'll take all that information into account in our conversation with the FDA. But I agree. I think if we can, very reminiscent of, I think, the discussions we had in CS, you could try to look at endpoints where you could see something going on earlier and, hopefully, with fewer patients. That's ideal because it is more difficult.
None: The you know the additional surrogate endpoints such as looking at the X Ray and some other endpoints so that might give us a better sense of the healing process in a short timeframe. There's also some kols, which are advocating looking at even shorter timeframe than the 12 weeks. We're looking so I think we'll see all of that again.
None: This study we're looking at a shorter time point in any way before kind of all of the applications kicking Ah well, obviously, followed the patients for a longer period of time, we will take all that information conversation with the FDA, but I agree I think if we can very reminiscence of I think the discussions we had and so yeah you can have them.
None: And try to look at endpoints, which you could see you know see something going on earlier and hopefully with less patients that's ideal because it is more difficult.
Joseph Pantginis: Absolutely. I really appreciate the color, Jonathan. Thanks.
None: Absolutely I really appreciate the color Jonathan Thanks.
Operator: [inaudible] Thank you. The next question today is coming from Michael Higgins from Lattinburg, Thalman. Your line is now live.
None: Right.
None: Thank you and next question today is coming from Michael Higgins from Ladenburg Thalmann. Your line is now live.
Michael John Higgins: Good morning, guys. This is behind on behalf of Mike Congrats again from US on the adaptive acquisition deal two question from Us on B X tableau far any feedback for us on any additional data analysis, you have going on from the part two data.
Farhana: Good morning guys. This is Farhana on behalf of Michael.
Jonathan Eitan Solomon: Congratulations again from us on the adaptive acquisition deal. Two questions from us on BX004. Any feedback for us on any additional data analysis you have going on from the Part 2 data? And, if yes, when might we see that additional data?
Michael John Higgins: And if yes, what might be see that additional data.
Jonathan Eitan Solomon: So, good morning, and thank you for the kind words. So far, we're not giving any guidance on anything new. We are considering presenting at a few of the top conferences, so once we have it and get, you know, the acceptance, we'll obviously update. I think the important activity that we're now gearing up for, except for the preparation for the next clinical study, is obviously the meeting with the FDA. So, that's something we're expecting in the middle of the year. That would be crucial, and again, as before, we are working hand-in-hand with the CF Foundation, and this kind of represents probably the most advanced phage program, so I think there's a lot of interest in the kind of feedback that the FDA will give us.
None: So good morning, and thank you for the kind words, so far where we're not giving any guidance on anything new we are considering a presenting in a few of the top congresses. So once we have it end and get you know the acceptance, we'll we'll obviously update.
None: I think the important activity that we're now gearing up to except for the preparation for the next clinical study is obviously the meeting with the FDA. So that's something we're expecting in the middle of the year that would be crucial and again as in before we are working hand in hand with the CF Foundation in this kind of represents probably the most advanced Ah phase.
None: Program, So I think theres a lot of interest in the kind of feedback that they feel will give us.
Farhana: All right, great. Thank you.
None: Alright, great. Thank you.
None: You bet.
Operator: Thank you. We have reached the end of our question and answer session. I'd like to turn the floor back over to management for any further closing comments.
None: Thank you we've reached end of our question and answer session I'd like to turn the floor back over to management for any further or closing comments.
None: So I just want to thank everyone for joining us this morning, and wishing you all a great day and hopefully we will keep on updating you as we make further progress. Thank you.
Jonathan Eitan Solomon: So I just want to thank everyone for joining us this morning and wish you all a great day, and hopefully, we'll keep on updating you as we make further progress. Thank you.
None: Thank you that does conclude today's teleconference and webcast you may disconnect. Your line at this time and have a wonderful day, we thank you for your participation today.
Operator: 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 today.