Q1 2024 BiomX Inc Earnings Call

Operator: Hello, and welcome to the Biomx first quarter 2024 financial results. If anyone should require operator assistance, please press star zero on your telephone keypad. Our question and answer session will follow the formal presentation. You can be placed into the question queue at any time by pressing star 1.

Hello, and welcome to the bio makes first quarter 'twenty 'twenty four financial results.

Speaker Change: Once you require operator assistance. Please press star zero on your telephone keypad.

Speaker Change: A question and answer session will follow the formal presentation.

Speaker Change: Seem to be placed in the question queue at any time by pressing star one.

Operator: As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to CFO Avi Gabay. Please go ahead, Avi.

Speaker Change: As a reminder, this conference is being recorded.

Speaker Change: Now my pleasure to turn the call over to CFO Avi Goodbye. Please go ahead Avi.

Avi Gabay: Thank you, and welcome to the Biomx First Quarter 2024 Financial Results and Corporate Update Conference Call. The press release became available just after 6.30 a.m. Eastern Time today and can be found on our website at www.biomx.com.

Avi Goodbye: Thank you and welcome to the bio makes first quarter 'twenty 'twenty four for natural results incorporate update conference call.

Speaker Change: The press release became available just offers at 630 a M. Eastern time today and can be found on our website at www <unk>.

Speaker Change: <unk> com.

Speaker Change: A replay of this call will also be available on the investors section of our website.

Avi Gabay: A replay of this call will also be available on the investor section of our website. Before we begin, I'd like to review the safe harbor provision. All statements on this call that are not factual historical statements may be deemed forward-looking statements. For instance, we're using forward-looking statements when we discuss in the conference call the sufficiency of the combined company's financing, potential stockholder approval of certain matters related to the securities issued and related matters in connection with the Adaptive Phase Therapeutics or APT merger, potential market opportunities, the ability to drive value for stockholders, the design, recruitment, aim, expected timing, and interim and final results of our preclinical and clinical trial, the regulatory process and discussion with the FDA, the potential benefits and commercial opportunities of our product candidate and the potential safety and efficacy of BX004 and BX211.

Speaker Change: Before we begin I'd like to review the Safe Harbor provision.

Avi Gabay: 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 trial. 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'll turn the call over to Jonathan.

All statements on this call that are not factual historical statement may be deemed forward looking statements for instance, we're using forward looking statements. When we discussed on the conference call. The sufficiency of the combined company's financing potential stockholder approval of certain matters related to the securities issued and related matters.

Jonathan Eitan Solomon: Good morning, everyone. For the first time, Biomx is reporting results for a combined entity following our merger with APT in March, and Avi will elaborate more on that. Overall, the first quarter of 2024 was nothing less than transformational for Biomx. The company has now entered into a new era.

Speaker Change: Connection with their adapted fate therapeutics or a P. P merger potential market opportunities the ability to drive value for stockholders the design recruitment.

Speaker Change: <unk> expects the timing and interim and final results of our preclinical and clinical trial, the regulatory process and discussion with the FDA the potential benefits and commercial opportunities of our product candidates and the potential safety and efficacy of being below four and books to one one.

Speaker Change: In addition, past and current pre clinical and clinical results as well as compassionate use 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.

Speaker Change: Right.

Speaker Change: Joining me the Cold. This morning is Jonathan Coleman, Chief Executive Officer of Bionics with that I'll turn the call over to Jonathan.

Jonathan Eitan Solomon: With the merger with APT in March, we have expanded our mid-clinical stage programs, which we believe constitute the leading phage-related pipeline in the industry. We are now advancing diverse approaches focused on developing the natural phage clock and personalized phages. With the recent merger, we've added a second Phase II product candidate, BX211, for the treatment of diabetic foot osteomyelitis, or DFO, and I'll review our progress shortly. BX004, our most advanced mid-clinical stage candidate, has already shown what we believe are promising clinical results supporting the potential of phage therapy to treat harmful bacteria underlying serious chronic infections in cystic fibrosis or CF patients.

Jonathan Eitan Solomon: Good morning, everyone for the first time buyer mix is reporting results for our combined entity following our merger with equity in March and the Avi will elaborate more on this.

Speaker Change: Overall.

Speaker Change: The first quarter of 'twenty 'twenty four was nothing less than transformational for bionics.

Avi Goodbye: The company has now entered into a new era with the merger with a P. T. In March we've expanded our mid clinical stage programs, which we believe constitute the leading phage related pipeline in the industry.

Avi Goodbye: We are now advancing diverse approach is focused on developing natural faith Clark and personal life stage events with the recent merger. We've added a second phase II product candidate, TX 211 for the treatment of diabetic foot osteomyelitis or do yourself.

Avi Goodbye: And I'll review our progress shortly.

Avi Goodbye: For our most advanced mid clinical stage candidate.

Speaker Change: Already shown what we believe our promising clinical results supporting the potential of phage therapy to treat harmful bacteria underlying serious chronic infections in cystic fibrosis or CF patients.

Jonathan Eitan Solomon: The broadening of our pipeline, the diversity of our approaches, and the data we've seen to date are all key to reducing the risk inherent in biotech development. Concurrently with the merger with APT, we raised $50 million of gross proceeds in a private placement led by affiliates of Deerfield Management and the AMR Fund with the participation of additional existing and new investors, including the Cystic Fibrosis Foundation, Orvimid, and Nathan Hala Capital Management.

Speaker Change: The broadening of our pipeline.

Speaker Change: The city of our approaches and the data we've seen to date are all key and reducing risk inherent in biotech development.

Speaker Change: Concurrently with the merger with ATT, we raised $50 million of gross proceeds in a private placement led by affiliates of Deerfield management N D. A more fun with the participation of additional existing and new investors, including the cystic fibrosis foundation or be made and nothing Halle capital management.

Jonathan Eitan Solomon: These important and accredited life sciences investors provide further validation for the potential of phage therapy as a new therapeutic modality and the strength of our lead candidates, each having the potential to advance the standard of care in their prospective disease areas. Including net proceeds from the financing and our existing capital, Biomx now expects to have sufficient funding to reach multiple important clinical milestones through 2025, including expected data readouts for our lead candidates BX211 and BX004 in the first quarter of 2025 and the third quarter of 2045, respectively.

These important an accredited life sciences investors provides further validation for the potential of phage therapy, as a new therapeutic modality and the strength of our lead candidates each having the potential to advance the standard of care in their perspective disease area.

Speaker Change: Including net proceeds from the financing and our existing capital by Alex now expect to have sufficient funding to reach multiple important clinical milestones through 2025, including expected data readouts for our lead candidates be extra one one and one four in the first quarter of 'twenty five in the third quarter of 25, respectively.

Jonathan Eitan Solomon: We believe these phase two data readouts could potentially drive significant value for shareholders. We are thrilled with the continuing progress of both of our Phase II programs. On our last earnings calls, I had the opportunity to take a deep dive into BX211 as part of the merger with ABC. As a reminder, BX211 is a personalized fate treatment being evaluated in a randomized, double-blinded, placebo-controlled, multi-center phase 2 trial for subjects with DFO associated with Staphylococcus aureus. This is an area of high unmet need.

Speaker Change: We believe these phase two data readouts could potentially drive significant value for our stockholders.

Speaker Change: We are thrilled with the continuing progress of both of our phase two programs on our last earnings calls I had the opportunity to take a deep dive into be X 211, as part of the merger with a P T.

Speaker Change: Reminder, being 211 personalized phage treatment being evaluated in a randomized double blinded placebo controlled multicenter phase two trial the subjects with DSO associated with Staphylococcus aureus.

Speaker Change: This is an area of high unmet need each year. He was a staggering number of approximately 160000, lower limb amputation and diabetic patients in the U S alone.

Jonathan Eitan Solomon: Each year, there is a staggering number of approximately 160,000 lower limb amputations in diabetic patients in the U.S. alone, 85% of which are caused by DSO, according to the Centers for Disease Control and the literature. We believe that phage-based therapeutic approaches have the potential to greatly improve treatment outcomes in VFO. Reports in the scientific literature of compassionate use with phage therapy have shown that 11 of 12 cases resulted in positive outcomes of wound healing and avoiding amputation.

Speaker Change: 85% of which are caused by DSO. According to the centers for disease control and the literature.

Speaker Change: We believe that phage based therapeutic approaches have the potential to greatly improve treatment outcomes in D. F. O reported in the scientific literature of compassionate use with phage therapy have shown that 11 of 12 cases resulted in positive outcomes of wound healing and avoiding amputation.

Jonathan Eitan Solomon: Findings from these cases played an important role in the design of the ongoing Phase 2 of BX211. With a target enrollment of 45 patients, the trial has already surpassed 70% of this target. We remain on track to report on Week 13 treatment results in the first quarter of 2025. We are also excited by the progress of BX004, our other lead mid-clinical stage candidate. BX004 is a fixed multi-stage cocktail for the treatment of CF patients with chronic pulmonary infections caused by Pseudomonas Arginosa, a main contributor to mobility and mortality in these patients.

Speaker Change: Finding from these cases played an important role in the design of the ongoing phase two.

Speaker Change: B X 211, with a target enrollment of 45 patients. The trial has already surpassed 70% of this target and we remain on track to report on the week 13 treatment results in the first quarter of 2025.

Speaker Change: We are also excited by the progress of Bx tableau for other than the mid clinical stage candidates picks up a little for it is it fixed multi phage cocktail for the treatment of CF patients with chronic pulmonary infections caused by extreme tomorrow, so getting us on a main contributor to the morbidity and mortality in these patients.

Jonathan Eitan Solomon: In January this year, we were granted orphan drug designation by the FDA for BX004. More recently, in April, we presented positive safety and efficacy results from Part 2 of the Phase 1b2a trial of BX1004 at the European Society of Clinical Microbiology and Infectious Diseases, or ESCNID, Global Congress. In fact, our presentation was selected as a top poster, ranking it among the top first and second percentile of top-rated abstracts and categories submitted and accepted at the Congress.

Speaker Change: In January of this year, we were granted orphan drug designation by the FDA for <unk> for.

Speaker Change: More recently in April we presented positive safety and efficacy results from part two of a phase one b to a trial a big stumble for at the European Society of clinical microbiology and infectious disease.

Speaker Change: Or yes C N I D Global Congress.

Speaker Change: In fact, our presentation was selected as the top poster ranking among the top first second percentile of top rated abstract in the category submitted and accepted at the Congress.

Jonathan Eitan Solomon: We believe that the data for BxL04 are the most promising advanced findings published to date for phage therapy for the treatment of chronic pulmonary infections in CF patients. We've shown with BX004 both conversion to sputum culture negative for pseudomonass aginosa in 14.3 percent of patients and demonstrated signals of improved pulmonary function after only 10 days of treatment, both findings in contrast to results with placebo. Under a phase 2b trial, we now plan to treat for a much longer treatment duration of two months, which we believe has the potential to demonstrate a more pronounced effect on both micrological and lung functional readout.

Speaker Change: We believe that the data for <unk> four are the most promising advance findings published to date, the phage therapy for the treatment of chronic pulmonary infections in CF patients.

Speaker Change: We've shown with be XL below for both conversion into sputum culture negative cinema.

Speaker Change: And 14, 3% of patients and demonstrated signals of improve pulmonary function. After only 10 days of treatments.

Speaker Change: Both findings in contrast, the results and placebo.

Speaker Change: Under a phase two b trial, we now plan to treat for a much longer treatment duration of two months, which we believe has the potential to demonstrate a more pronounced effect on both microbiological in lung functional readouts.

Jonathan Eitan Solomon: As previously reported, by mid-2024, we anticipate holding a type C meeting with the FDA to discuss our clinical development plans for BX004. Pending alignment with the FDA and completion of the remaining CMC work, our plan is to submit a phase 2B study protocol to all relevant regulatory authorities and initiate the study by the end of this year. As already noted, we estimate releasing top-line results from the study in the third quarter of 2025.

As previously reported by mid 2024, we anticipate holding a type C meeting with the FDA to discuss our clinical development plans for the XL below four pending alignment with the FDA and completion of the remaining CMC work. Our plan is to submit our phase III study protocol to all relevant regulatory authorities and initiate the study by the end of this year.

Speaker Change: As already noted we estimate releasing topline results under study in the third quarter of 2025.

Jonathan Eitan Solomon: We are thrilled to have what we believe is the broadest and most advantaged phage pipeline with promising data already reported and key readouts and phase 2 studies in both our lead programs in 2025. On this final note, I'll now pass it over to Avi to review our first quarter 2024 financial results. Avi?

Speaker Change: We are thrilled to have what we believe is the broadest and most advanced stage pipeline with promising data already reported in key Readouts and phase II studies in both of our lead programs in 2025 on this final note ill now pass it over to Avi to review, our first quarter 'twenty 'twenty four financial results hobby.

Speaker Change: Thank you Jonathan.

Avi Gabay: 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-Q that was filed yesterday. 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-Q that was filed yesterday.

Why for us through some of our brief highlights.

Avi Gabay: As of March 31, 2024, the cash balance and short-term deposit were $44.1 million, compared to $30.3 million as of March 31, 2023. The increase was primarily due to the private placement, which was partially offset by net cash using operating activities and the repayment of the debt facility in March 2024. The company estimates its cash, cash equivalents, and short-term deposits are sufficient to fund its operations throughout the fourth quarter of 2025.

Avi Goodbye: As of March 31, 2020 for cash balance and short term deposits were $44 $1 million compared to $30.3 million as of March 31 2023.

Avi Goodbye: The increase was primarily due to the private placement, which was partially offset by net cash used in operating activities and the repayment of the debt facility in March 2020 for.

Avi Goodbye: The company estimates its cash cash equivalents and short term deposits are sufficient to fund its operations throughout the fourth quarter of 2025.

Avi Gabay: In the first quarter of 2024, research and development expenses net totaled $4.1 million dollars compared to $4.6 million dollars in the first quarter of 2023, mainly because of last expenses due to the end of the CF clinical trial and were partially offset by lower grant payments from the Israeli Innovation Authority and R&D expenses related to the APT that were incurred after the merger. General and administrative expenses were $2.7 million for the first quarter of 2024, compared to $1.6 million for the same period in 2020.

Avi Goodbye: In the first quarter of 2020 for research and development expenses totaled $4 $1 million compared to $4 $6 million in the first quarter of 2023.

Avi Goodbye: Mainly because of less expenses due to the end of the CF clinical trial and was partially offset by lower grants payment from these weird innovation authority and R&D expenses related to the a P. T that were incurred after the merger.

Avi Goodbye: General and administrative expenses were $2 $7 million for the first quarter of 2024 compared to $1 $6 million for the same period in 2023.

Avi Gabay: The increase was primarily due to expenses related to the merger with APT and the concurrent private placement. Net loss for the first quarter of 2024 was $17.3 million compared to $6.4 million for the first quarter of 2023. The increase was mainly due to the change in the fair value of private placement warrants that were issued in this quarter.

Avi Goodbye: The increase was primarily due to expenses related to the merger with a P D and a concurrent private placement.

Yeah.

Avi Goodbye: Net loss for the first quarter of 2024 was $17.3 million compared to $6.4 million for the first quarter of 2023.

Avi Goodbye: The increase was mainly due to change to fair value of private placement warrants that were issued.

Avi Goodbye: Issued in this quarter.

Avi Gabay: Net cash used in operating activity for the first quarter of 2024 was $11.4 million, compared to $5 million for the same period in 2020. On March 15, 2024, we closed the merger with APT, concurrent with an investment of $15 million. We would like to emphasize that although after the financing, we believe we will have sufficient cash, cash equivalents, and short-term deposits to fund our current operating plan for at least 12 months, our financial statements contain an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.

Avi Goodbye: Net cash using operating activities for the first quarter of 2024 was $11.4 million compared to $5 million for the same period in 2023.

Avi Goodbye: On March 15, 2024, we closed the merger with ADT concurs with an investment of $15 billion, who would like to emphasize that although after the financing. We believe we will have sufficient cash cash equivalent and short term deposits to fund our current operating plan at least 12 months our financial statements contained in <unk>.

Avi Goodbye: Planetary paragraph regarding substantial doubt about our ability to continue as a going concern. This is mainly due to the potential risk of our stockholders not approving the conversion of the convertible preferred stock that was issued as part of the merger with EQT and the concurrent investment.

Avi Gabay: This is mainly due to the potential risk of our stockholders not approving the conversion of the convertible preferred stock that was issued as part of the merger with APT and the concurrent investment. Now I'll turn the call back over to Jonathan for his closing remarks. Jonathan, we've accomplished a lot too.

Speaker Change: Now I'll turn the call back over to Johnson for his closing remarks Jonathan.

Jonathan Eitan Solomon: We've accomplished a lot so far in 2024, and we're looking forward to the continuing substantial momentum at Biomx through this year and into 2025. With recent developments, Biomx has set itself apart as a leader in developing phage-based therapeutics.

Johnson: We've accomplished a lot so far in 'twenty 'twenty four and we're looking forward to the continuing substantial momentum at bionics, who this year and into 2020 five.

Speaker Change: With recent development bionics that set itself apart as a leader in developing phage based therapeutics, the merger and $50 million investment in top institutional healthcare investors allowed us to expand our pipeline now position us to achieve key data Readouts next year.

Jonathan Eitan Solomon: The merger and $50 million investment from top institutional healthcare investors allowed us to expand our pipeline and position us to achieve key data readouts next year. By advancing our BX004 and BX211 clinical programs, our company is poised to build significant value for our stockholders. As at the recent ESCMID Congress, our team will continue to seek important opportunities to present in peer-reviewed form. Based on our recent financing, we believe the company has sufficient cash runway to reach additional important clinical mod zones as we advance our phage candidates addressing serious chronic infections. Indeed, it is a new era for Biomx.

Speaker Change: By advancing our big stumble four and Biggs to one one clinical programs. Our company is poised to build significant value for our stockholders.

As at the recent E. S. C N D Congress, our team will continue to seek and point opportunities to present and peer reviewed forums.

Based on our recent financing we believe the company has sufficient cash runway to reach additional important clinical milestones as we advance our phage candidates addressing serious chronic infections. Indeed, it is a new era for bionics.

Speaker Change: Yeah.

Operator: Thank you. We'll now be conducting a question and 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 2 if you would like to remove your question. One moment, please, while we pull for questions. And once again, that's star number one to be placed in the question queue. Our first question today is coming from Joe Pantginis from HC Wainwright. Your line is now live.

Speaker Change: Thank you well now be conducting a question and answer session if you'd like to be placed in the question queue. Please press star one on your telephone keypad.

Speaker Change: A confirmation tone will indicate your line is in the question queue. You May press star two if you'd like to remove your question from me Q1 moment. Please while we poll for questions and once again that is star one to be placed in the question queue.

Speaker Change: Our first question today is coming from Joe Pan Janus from H C. Wainwright Your line is that life.

Joseph Pantginis: Hey guys, good morning, good afternoon. Thanks for taking the time to answer the question. So two questions, Jonathan. First, for the upcoming Phase 2B and CF, I was just curious, I mean, even since your year-end call or whatever you've been talking to additional physicians and KOLs, has there been any additional evolution in your thinking about the design of the study, inclusion criteria, et cetera, going into your Type C meeting? And then the second question is, how are your integration efforts going with regard to the Bering Manufacturing Facility? Thanks a lot.

Speaker Change: Hey, guys. Good morning. Good afternoon. Thanks for taking the question. So two questions Jonathan first for the upcoming phase two B and C. S. I was just curious I mean, even since you're on your year end call or what have you been talking to you know additional physicians and Kols has there been any additional evolution in your thinking about the design of the study.

Speaker Change: Inclusion criteria et cetera going into your type C meeting and then the second question is how will your integration efforts going with regard to the dairy manufacturing facility. Thanks a lot.

Jonathan Eitan Solomon: Good morning, Joe, and thanks for the great questions, as always. So first, on the CF study. You know, we spent quite a lot of time analyzing the data and working hand in hand with the CF Foundation. So I think we have a good handle on the design of the Phase 2B trial, trying to address some of the questions that we've discussed and trying, obviously, you know, to increase the percentage of patients that experience conversion and get, you know, even clearer signals on both microbiology as well as clinical endpoints.

Joe: Good morning, Joe and thanks for the great questions as always and so first on on the CF study. So you know we spent quite a lot of time analyzing the data and working hand in hand with the CF Foundation. So I think we have a good handle on the design of the phase two b I'm trying to address some of the questions that we do.

Gaston: Gaston and trying obviously to increase the percentage of our patients that experience conversion in and get you know even clearer signals.

Jonathan Eitan Solomon: So I think that is as matured as matured. Again, I think we're waiting for the FDA meeting, and we'll see kind of where the feedback is. If all is according to plan, then I think, you know, we're locked and loaded to initiate the study at the end of the year. So, so far, I think. Again, there was a lot of work up front, so I think I think we feel good about it. The integration. So I'm now in sunny DC; by the way, the weather is gorgeous.

Gaston: On both microbiology as well as clinical endpoints. So I think that is as matured again I think we're we're waiting for the FDA meeting and we'll see kind of where the feedback is if all goes. According to plan then I think you're we're locked and loaded to initiate the study at the end of the year. So so far I think.

Gaston: Again, there was a lot of our work upfront.

Gaston: So I think I think we feel good about it the integration. So I'm now in Sunny D. C by the way the weather is it's gorgeous.

And you know, it's definitely not a simple task to integrate these two companies.

Jonathan Eitan Solomon: And, you know, it's definitely not a simple task to integrate these two companies. But I think as time goes by, the rationale kind of plays out, right. So I do think it plays into APT's strengths, in terms of the manufacturing capability, the access to, you know, the compassion cases, the knowledge, and access to governmental agencies. So I think all those are strengths that, quite frankly, Biomx lacked.

Gaston: But I think as time goes the rationale kind of plays out right. So I do think it plays into <unk> strength.

Gaston: In terms of the manufacturing capability.

Gaston: Access to you know a compassionate cases the knowledge.

Gaston: Access to governmental agency. So I think all of those are strengths that are quite frankly bionics lacked.

Gaston: So I think its proceeding well like every integration you know, it's not simple, but you know there's been a lot of effort. The teams have been traveling quite extensively.

Jonathan Eitan Solomon: So I think it's proceeding well; like every integration, you know, it's not simple. But you know, there's been a lot of effort, the teams have been traveling quite extensively, and now I think we feel that the situation is sort of stabilized. And there are very clear work plans, budgets approved, and we're ready to go. So I'm crossing my fingers to kind of continue the momentum and again generate more value.

Gaston: And now I think we feel that the situation is sort of a stabilized and there's very clear work plans budgets approved and we're ready to go so crossing our fingers to kind of continue the momentum and again generate more value.

Joseph Pantginis: I appreciate the comments. Thanks, Jonathan.

Speaker Change: I appreciate the comments thank you Jonathan.

Speaker Change: Alright.

Operator: Thank you. The next question is coming from Yale Gen from Leigh Loan Company. Your line is now live.

Speaker Change: Thank you next question is coming from Yale Jen from Laidlaw <unk> Company. Your line is that life.

Speaker Change: Yeah.

Yale Gen: Good afternoon and thanks for taking the questions and congratulations, Jonathan. I've got two questions here. First one is just to follow up on Joe's question, which is that in terms of the phase two study you're proposing, would that potentially add an extension part after the trial was done so a patient can get a longer treatment? And that's one, and then I have a follow-up.

Yale Jen: Good afternoon, and thanks for taking the question.

Yale Jen: Jonathan.

Jonathan Eitan Solomon: I've got two questions first one just follow up.

Speaker Change: Joe's question, what's your thought in terms of the phase two study are proposing.

Speaker Change: Would that be.

Speaker Change: Potentially adding.

Speaker Change: After the trial is done so a patient can get a longer sheet, but and that's one.

Speaker Change: Follow up.

Jonathan Eitan Solomon: Okay, so I think, you know, phase two is already quite a long duration, right? We're going for two months.

Speaker Change: Okay. So I think you know.

Speaker Change: The phase two is already quite a long duration.

Jonathan Eitan Solomon: And we'll follow up the patients and think about whether we extend it if we're seeing conversion. So I think these are items that we're discussing. You know, I think a lot depends on feedback from the FDA. There will be a longer follow-up for sure. I do think there's a chance to also explore extending it. Definitely, I think we'll want to extend it to some extent in the patients that have experienced conversion, kind of see how long we can keep the, you know, the bug at bay, right? So I think that would be very dramatic. So it's definitely one of the items that we're discussing, and Yael, I believe you had another question.

Speaker Change: Duration right, we're going for two months.

Speaker Change: We will follow up with patients and think about whether we extend if we're seeing conversion. So I think these are items that were worth discussing.

Speaker Change: You know I think a lot depends on on feedback from da there will be a longer follow up for sure I do think there's a chance to also explore extending it definitely I think we would want to extend to some extent in the patients that have experienced conversion kind of see how long can you keep the you know as a.

Speaker Change: Back at Bay right. So I think that would be very dramatic. So it's definitely one of that and so we're discussing and and Yale I believe you had another question.

Yale Gen: Yes, I do. And this is a little bit more fundamental question here. As we know that the virus, I'm sorry, the phage has the lytic and the lysogenic phase. So how would you ensure that all your products are retained in the lytic state and that that will be the most effective state of the phage for killing the bacteria? And thanks.

Yale Jen: Yes. Thank you and this is a little bit more fundamental questions here, Oh, we know that the virus.

Speaker Change: Alright.

Speaker Change: Ludwig.

Speaker Change: Okay.

Speaker Change: So how would you ensure that Oh you are proud that we obtained in the literature.

Speaker Change: And that that will be the most that is the function of the off the FH will kill the bacteria and thanks.

Jonathan Eitan Solomon: Yeah, it's a good question. And, you know, phages are viruses, right? So I do think it's a valid analogy, you know, by the way, the big conference is like viruses and microbes, the phage. I think, to your point, the FDA has been very clear on not wanting to advance forward phages, which are lysogenic, right? And the way to address it is actually by making sure that all the phages that we deploy, whether in the personalized approach, such as the DFO study, or in the cocktail, actually don't have any lysogeny genes. So we sequence everything. Again, these are quite a few genes, so it's not that a spontaneous single mutation will introduce lysogeny, right?

Speaker Change: Yeah, Yeah. It's a good question and you know you know viruses are yeah page are viruses right. So I do think that.

Speaker Change: It's a valid analogy you know I'm by the way the big conferences like viruses microbes, the phage conference and I think to your point if the FDA has been very clear on not wanting to advance forward stage, which are lysogenic right and the way to address it is actually by making sure that all of the fee.

Speaker Change: <unk> that we do.

James: Deploy whether in the personalized approach such as the <unk> study or in the cocktail actually don't have any lysogeny. James So we sequence everything again. These are quite a few James so it's not that a spontaneous single mutation will introduce lifestyle journey right. It's not that we knocked off like longevity with a single mutation Theres no exogenous genes.

Jonathan Eitan Solomon: It's not that we knocked off lysogeny with a single mutation. There are no lysogeny genes whatsoever, so, you know, the probability of a phage kind of acquiring or developing lysogeny genes is measurable. So that's the approach, again, sequencing, making sure that the phages don't have those capabilities, and it's all part of a battery of tests, you know, such as generalized transduction and other attributes that the FDA has been very clear on what kind of characteristics they want to see and what characteristics they don't want to see in a phage product undergoing development.

James: Whatsoever. So you know the probability of a phage kind of acquiring or developing ones answering James says it's inevitable. So that's the approach again sequencing, making sure that the fates don't have those capabilities and it's all part of a battery of tests.

James: Such as generalized transaction and other attributes that that the FDA has been very clear on you know what kind of characteristic and what they want to stay and what characteristics would be don't want to see.

James: And our faith product underground development.

Yale Gen: Okay, great. That's very helpful for investors. And again, congrats on all the progress, and I look forward to talking to you.

Speaker Change: Okay, Great that's very helpful.

And again congrats on all the progress.

Speaker Change: Okay.

Jonathan Eitan Solomon: Thanks, Gail, for the kind words.

Thanks for the kind words.

Operator: Thank you. Your next question today is coming from Michael Higgins from Landenburg-Baumann. Your line is now live.

Speaker Change: Thank you. Our next question today is coming from Michael Higgins from Ladenburg Thalmann. Your line is now live.

Michael John Higgins: Hi guys, good morning. This is Farhana on behalf of Michael. Congratulations on your continued progress.

Speaker Change: Hi, guys. Good morning. This is kind of hung on behalf of Michael Congrats on you all continue to talk about to.

Farhana: Two questions from us. The first is on BX004. Could you confirm with us that aligning with the EMA is also planned for 2024? And the second question is on BX211. Are there any gating factors to completing enrollment in the Phase 2 DFO study? So, good morning.

Speaker Change: Two questions from us the first time to be X tableau far.

Could you confirm with us at aligning with the E. M. It's also in 'twenty 'twenty four and the second question is on VX 211, any gating factors to completing enrollment in the phase two D. F O study.

Jonathan Eitan Solomon: So good morning and good questions. Just to make sure regarding the first question, you mean the European compliance of the X004? Got it. Okay.

Speaker Change: So good morning, and good questions just to make sure regarding the first question you mean like the European compliance.

Speaker Change: Except below four.

Speaker Change: Got it okay. So so all good question again, yeah, because tableau for going after CF orphan indication you know as as we've talked through the years right recruitment is not trivial we struggled a bit in the part one and I think then we gain a lot of momentum in the part two.

Jonathan Eitan Solomon: So, all good questions. Again, BX004, going after CF, orphan indication, as we've talked through the years, recruitment is not trivial. We struggled a bit in part one, and I think then we gained a lot of momentum in part two, but that was already a global study, right? So already in part two of phase 2a, we had US sites, European sites, as well as Israeli sites. So that's going to continue. I think we're looking at much more sites in the second phase 2b study. Definitely, Europe is going to be key.

Speaker Change: But that already was a global study right so already in the part and the part.

Speaker Change: Two of the Phase Iia, we had our U S sites European sites as well as Israeli sites. So that's going to continue I think we're looking at much more sites in the in the second study of the phase two be definitely Europe is going to be key I think there's.

Jonathan Eitan Solomon: I think we've experienced, I think, very good recruitment in the US, and we'll definitely continue that. So that's in the works and part of the work plan and the timelines that we've presented. BX211, so enrollment is going well; as reported this morning, 70% of patients have been enrolled. Again, I think these studies are not trivial, it's a complex indication; we want to verify that the patients have the bacteria. We're deploying phage banks, that means that we ship phages to our sites, we optimize the best phage for that patient, we ship it back, and that's the treatment that the patient gets.

Speaker Change: We've we've experienced I think very good recruitment in the U S and we will definitely continue with that so that's in the works and you know part of the work plan and the timelines that we've presented.

Speaker Change: <unk> to one one so enrollment is going well as reported this morning, 70% of patients had been enrolled again I think these studies are not trivial amounts of complex indication we want to verify.

Speaker Change: That the patients have the bacteria.

Speaker Change: We're deploying a the phage bank so that means that we ship basically phage to our sites, we optimize the best phage for that Ah patient.

Speaker Change: Patient and we ship it back and that the treatment that the patient gets so we have seen challenges again, there's there's a lot of experience in the system by now. These studies. So you know I think we've learned a lot we work with some have already been to try to.

Jonathan Eitan Solomon: So we have seen challenges, again, there's a lot of experience in the system by now with these studies, so I think we've learned a lot. We will make some effort even to try to, if we can, improve recruitment rates, but so far, it's going well and it's meeting our expectations, but clinical studies are always difficult, so let's just hope it continues the way it has.

Speaker Change: If we can improve recruitment rates, but so far it's going well and it's meeting our expectations, but we know clinical studies always difficult. So let's just hope it continues the way it has.

Speaker Change: Okay. Thank you.

Speaker Change: Yeah.

Operator: Thank you. We've reached the end of our question and answer session. I'd like to turn the floor back over to you for any further closing comments.

Speaker Change: Thank you we reached end of our question and answer session I'd like to turn the floor back over for any further or closing comments.

Jonathan Eitan Solomon: Thank you again, everyone, for joining us this morning. We look forward to providing you with updates throughout the year. Have a great day. Thank you.

Speaker Change: So thank you again, everyone for joining us. This morning, we look forward to providing you with updates throughout the year and have great day. Thank you.

Operator: 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.

Speaker Change: 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.

Speaker Change: Yeah.