Q3 2024 BiomX Inc Earnings Call

Unknown Executive: Greetings and welcome to the Biomx third quarter 2024 financial results conference call. At this time, all participants are in a listen only mode. The question and answer session will follow the formal presentation.

Greetings and welcome to the bottlenecks third quarter 2024 financial results Conference call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone.

Unknown Executive: If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded.

Keypad as a reminder, this conference is being recorded it is now my pleasure to introduce Marina Watson Chief Financial Officer. Thank you you may begin.

Marina Wolfson: It is now my pleasure to introduce Marina Wolfson, Chief Financial Officer. Thank you. You may begin.

Marina Wolfson: Thank you and welcome to the Biomx conference call to review the company's third quarter 2024 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 6.30 a.m. Eastern Time today and can be found on our website at biomx.com. A replay of this call will also be available on the investors section of our website.

Marina Watson: Thank you and welcome to do by our next conference call to review the company's third quarter 2024 financial result, and provide an update on our business and programs.

Marina Watson: Later today, we will file our quarterly report on Form 10-Q, with the Securities and Exchange Commission.

In addition, the press release became available at 630 am Eastern time today and can be found on our website at <unk> Dot com.

This call will also be available on 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 forward-looking statements when we discuss on 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 preclinical and clinical trials, the potential benefits of our product candidates, and the potential safety or efficacy of our product candidates, BX004 and BX211. In addition, past and current preclinical and clinical results, as well as compassionate views, are not indicative and do not guarantee future success of our clinical trial.

Marina Watson: As we begin I'd like to review the Safe Harbor provision.

Marina Watson: All statements on this call they're not factual historic statement may be deemed forward looking statements.

Austin: Austin, we're using forward looking statements when we discussed on the conference call. The sufficiency of the company's cash our pipeline the design with click meant and expected timing and interim and final results of our preclinical and clinical trials the potential benefits of our product candidates and the potential safety or efficacy.

Austin: All of our product candidates the X to below four and VX 211.

Austin: In addition, past and current preclinical and clinical results as long as compassionate use or not.

Austin: Not indicative and do not guarantee future success of our clinical trials.

Marina Wolfson: Accept as required by law, we do not undertake to update forward looking state. The full safe harbor provision, including risks that could cause actual results to differ from this forward-looking statement, are outlined in today's press release. which is noted earlier is on our website.

Austin: Except as required by law, we do not undertake to update forward looking statements.

Austin: So 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.

Jonathan Solomon: Joining me on the call this morning is Biomx Chief Executive Officer Jonathan Solomon, to whom I will now turn over the call. Thank you, Marina. Good morning, everyone. Thank you for joining Biomx's quarterly update. Throughout the last quarter, Biomx has focused on strategic execution and advancing our clinical pipeline. We are excited as we approach the landmark milestones in our diabetic foot osteomyelitis, or DSO, phase two trial of BX211. In the past quarter, we completed patient enrollment for the trial and the readout for top line results through week 13 is expected in the first quarter of 2025.

Austin: Joining me on the call. This morning is bound <unk>, Chief Executive Officer, Jonathan and sell them to whom I will now turn over the call.

Speaker Change: Thank you Marina good morning, everyone.

Speaker Change: Thank you for joining by Amish quarterly update throughout.

Speaker Change: Throughout the last quarter, but I'm actually just focus on strategic execution and advancing our clinical pipeline. We are excited as we approach a landmark milestones and our diabetic foot osteomyelitis or DSO phase II trial of <unk> one one.

In the past quarter, we completed patient enrollment for the trial and the readout for topline results through week 13 is expected in the first quarter of 2025.

Jonathan Solomon: We are grateful for the continued support behind the DFO program from the U.S. Defense Health Agency, or DHA, which provided additional funding this past quarter, bringing total non-dilutive funding received from the DHA towards this trial to $36.8 million to date. BX211 has the potential to dramatically transform treatment for patients suffering from DFO associated with staphylococcus aureus. This is an area of high unmet need. 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 estimated to be caused by DSO, according to the current literature and the U.S.

Speaker Change: We are grateful for the continued support beyond the DSO program in the U S Defense Health agency with DHA, which provided additional funding this past quarter, bringing total non dilutive funding received from the Doj towards this trial to $36 $8 million to date.

Speaker Change: The extra one one has the potential to dramatically transform treatment for patients suffering from DSO associated with Staphylococcus aureus.

This is an area of high unmet need each year. There was a staggering number of approximately 160000, lower limb amputation and diabetic patients in the U S alone, 85% of which are estimated to be caused by DSO. According to the current literature in the U S centers for disease control.

Jonathan Solomon: Centers for Disease Control. CFO is characterized by intractable infections that have penetrated the bone in patients with diabetic foot ulcer. Antibiotic therapy is the current standard of care, but fails to treat 30 to 40% of cases due to antibiotic resistance, accumulation of biofilm, and poor blood supply, limiting the concentration of IV and oral antibiotics to the site of infection. We believe that a phage-based therapeutic approach has the potential to greatly improve treatment outcomes in DFO. Phage's potential advantage stands in the ability to address challenges that antibiotics face, such as breakdown of biofilm and targeting antibiotics-resistant bacteria.

Speaker Change: CFO is characterized by intractable infections that have penetrated the bone in patients with diabetic foot ulcers antibiotic therapy. The current standard of care, but fails to treat 30% to 40% of cases due to antibiotic resistance accumulation of biofilm and poor blood supply limiting the concentration of IV and oral antibiotics, because the size of <unk>.

Speaker Change: Section.

We believe that a phage based therapeutic approach has the potential to greatly improve treatment outcome and DSO.

Speaker Change: They just potential advantage stance and the ability to address challenges the antibiotic space such as breakdown of biofilm and targeting antibiotic resistant bacteria.

Jonathan Solomon: Reports in the scientific literature of compassionate use with phage therapy for the treatment of DFO associated with staph aureus have shown that 11 of 12 cases resulted in positive outcomes of wound healing and avoiding amputations. Finding from these cases played an important role in the design of the ongoing Phase II study of BX211. As a reminder, the Phase 2 is a randomized, double-blind, placebo-controlled, multicenter study investigating the safety, tolerability, and efficacy of BX211 in the standard of care antibiotics in subjects with DFO due to staph aureus. Enrolled subjects are randomized with a 2 to 1 ratio to BX211 or placebo.

Speaker Change: Reports in the scientific literature of compassionate use with phage therapy for the treatment of DSO associated with Staph aureus have shown that 11 of 12 cases resulted in positive outcomes wound healing and avoiding amputation.

I think from these cases has played an important role in the design of the ongoing phase II study of <unk> one one.

Speaker Change: As a reminder, the phase two is a randomized double blind placebo controlled multicenter study investigating the safety tolerability and efficacy of the extra one one and the standard of care antibiotics in subjects with DSO due to staph aureus enroll subjects are randomized two to one ratio to be extra one one or placebo.

Jonathan Solomon: BX211 or placebo are administered weekly by topical IV route in week 1 and by the topical route only in each of weeks 2 to 12. Over a 12-week treatment period, all subjects are expected to continue to be treated in accordance with the standard of care, which will include antibiotic treatment as appropriate. The first readout of top-line results is expected week 13 evaluating the healing of the wound associated with osteomyelitis.

Speaker Change: <unk> hundred one or placebo administered weekly by topical IV route in week, one and by the topical route only in each of weeks two to 12 over a 12 week treatment period. All subjects are expected to continue to be treated in accordance with the standard of care, which will include antibody treatment as appropriate.

Speaker Change: First readout of top line results expected week 13 of Diamond the healing of the wound associated with osteomyelitis.

Jonathan Solomon: With respect to BXL04, the company's novel fixed-phase cocktail for the treatment of serious chronic lung infection in cystic fibrosis or CF patients caused by Pseudomonas aeruginosa, we are continuing preparation towards the Phase IIb study. During the last quarter, the company has experienced manufacturing delays for BX004. The team has been working diligently to address these manufacturing challenges, which have been successful results. However, as a result of these delays, we now expect to report top line results for BX004 Phase 2B study in the first half of 2021. During the third quarter, we present positive safety and efficacy results in BIG-004 Phase I B2A trial at the North American Cystic Fibrosis Conference and the European Respiratory Society's annual meeting.

Speaker Change: With respect to be acceptable for the company's novel fixed phage cocktail for the treatment of serious chronic lung infection, and cystic fibrosis or CF patients caused by Pseudomonas aeruginosa, we're continuing preparation towards a phase <unk> study.

Speaker Change: During the last quarter the company has experienced manufacturing as well as for Bx tableau for the team has been working diligently to address these manufacturing jobs, which have been successfully resolved. However, as a result of these delays. We now expect to report topline results from VX tableau for Phase <unk> study in the first half of 2026.

Speaker Change: During the third quarter, we presented positive safety and efficacy results in big stay below four phase <unk> trial at the North American Cystic fibrosis conference in the European Respiratory Society annual meeting key highlights of the study presented including that three out of 21 patients, which reflects 14, 3%.

Jonathan Solomon: Key highlights of the study presented including that 3 out of 21 patients, which reflect 14.3%, converted to sputum culture negative for pseudomonas aeruginosa after 10 days of treatment, including 2 patients after only 4 days in the BXOO arm, compared to 0% of the patients in the placebo arm. New data presented included that lung function as measured by four... respiratory volume in one second, or FEV1, increase in subjects receiving the cocktail compared to placebo. In the subgroup, on continuous inhaled antibiotics, meaning same antibiotic with no cycling or altering regimen, on CFTR modulators and with lower lung functions, meaning FEV1 lower than 70%.

Speaker Change: <unk> to sputum culture negative for Pseudomonas certainly enough after 10 days of treatment, including two patients. After only four days in the <unk> arm compared to zero percent of the patients in the placebo arm.

Speaker Change: New data presented included that lung function as measured by forced expiratory volume in one second or <unk> one.

Speaker Change: The increase in subject to receiving the cocktail compared to placebo in the subgroup on continuous inhaled antibiotics, meaning same antibiotic with no cycling around training regimen answer after modulators and with lower lung function, meaning F&B, one lower than 70%.

Jonathan Solomon: The scientific community's positive feedback to the data presented at these conferences has only further strengthened our confidence about the future of this program and its potential to address the unmet medical need of cystic fibrosis patients. Overall, we are confident about the promising data already reported and are looking forward to the first quarter of 2025, which will mark the next significant milestone for the company upon reporting top-line results for BX211 Phase II trial in the DFO. We believe our pipeline showcases the potential of faith therapy to address a wide range of antibiotics and infections.

Speaker Change: The scientific community positive feedback to the data presented these countries has only further strengthens our confidence about the future of this program and its potential to address the unmet medical need of cystic fibrosis patients.

Speaker Change: Overall, we are confident about the promising data already reported and are looking forward to the first quarter of 2025, which will mark the next significant milestone for the company upon reporting topline results for <unk>, one one phase II trial in DSO, we believe our pipeline showcases the potential phase therapy to address a wide range of antibiotic resistant infections.

Marina Wolfson: I'll now pass you to Marina to review our third quarter financial results. Thank you, Jonathan. As a reminder, the financial information for the company's third quarter 2024 is available in the press release that we issued earlier today, as well as in more detail in our form.

Marina Watson: I'll now pass you to Marina to review, our third quarter financial results.

Marina Watson: Thank you Jonathan as a reminder, the financial information for the company's third quarter 2024. It is available in the press release that we issued earlier today and said rather than like detail in our Form 10-Q, which rather file later today.

Marina Wolfson: Thank you, which we will file later today. I will now walk you through the highlights of our third quarter financial results. Cash balance short term deposits and restricted cash as of September 30, 2024, or $24.7 million compared to $30.7 million as of December 31, 2023. The decrease is primarily due to net cash used in operating activities and the repayment of a Hercules debt facility, which was partially offset by the company's private placement financing of $50 million in March of 2020. We estimate that our cash, cash equivalents and short term deposits are sufficient to fund our operations into the fourth quarter of 2024.

Marina Watson: I will now walk you through the highlights of our third quarter financial results.

Cash balance short term deposits and restricted cash as of September 30th 2024, or $24.7 million compared to $37 million as of December 31 2022 the.

The decrease was primarily due to net cash used in operating activities and the repayment of our Hercules debt facility, which was partially offset by the company's private placement financing of $50 million in March of 2024.

Marina Watson: Estimated our cash cash equivalents and short term deposits are sufficient to fund our operations into the fourth quarter of 2025.

Marina Wolfson: Research and development expenses net were $7.3 million for the third quarter of 2024, compared to $5.6 million for the same period in 2023. The increase was primarily due to the following factors, preparations for the phase 2b trial of our CF product candidate, BX004, an increase in expenses relating to the clinical trial of our DFO product candidate, BX211, and an increase in rented related expenses following our March acquisition of Adaptive Stage Therapeutics, or APT. This increase was partially offset by higher grants received. General and administrative expenses were $3.2 million for the third quarter of 2024 compared to $2.2 million for the same period in 2023.

Marina Watson: Research and development expenses net were $7 $3 million for the third quarter of 2024 compared to $5 $6 million for the same period in 2022.

Marina Watson: The increase was primarily due to the following factors preparations for the phase two b trial of our CF product candidates do you accept below four.

Marina Watson: An increase in expenses, but they didn't get the clinical trial of ideas. So product candidate <unk> 211, and an increase in rent and related expenses. Following our March acquisition of adaptive stage therapeutics.

Marina Watson: This increase was partially offset by higher branch system.

Marina Watson: General and administrative expenses were $3 $2 million for the third quarter of 2024 compared to $2.2 million for the same period in 2020.

Marina Wolfson: The increase is primarily attributed to a full quarter consolidation of expenses following APT's March acquisition, incorporating the combined workforce, increased professional services, and additional subcontractor. In the third quarter of 2024, we recognized goodwill impairment expenses of $801,000, resulting from the fair value assessment of goodwill related to the 2024 APT acquisition.

Marina Watson: The increase is primarily attributed to a full quarter consolidation of expensive following Apt's March acquisition, incorporating the combined workforce increased professional services and additional subcontractor expenses.

Marina Watson: In the third quarter of 'twenty 'twenty, four we recognized goodwill impairment expenses of $801000.

Speaker Change: I think from the fair value assessment of goodwill related to the 'twenty 'twenty four and a P T acquisition Nelson.

Marina Wolfson: No comparable goodwill impairment expenses were recorded in the same period of 2020. net income was $9.6 million for the third quarter of 2024 compared to a net loss of $7.9 million for the same period in 2023. They increase primarily reflect non-cash income from the revaluation of warrants issued during the March 2024 financing. Net cash used in operating activities for the nine months ended September 30, 2024, was $30.7 million, compared to $15 million for the same period in 2023.

Speaker Change: No comparable goodwill impairment expenses recorded in the same period of 2022.

Speaker Change: Net income was $9 $6 million for the third quarter of 2024 compared to a net loss of $7 $9 million for the same period in 2023.

The increase primarily reflects noncash income from the revaluation of warrants issued during the March 'twenty 'twenty four financing.

Speaker Change: Net cash used in operating activities for the nine months ended September 32024 was $37 million compared to $15 million for the same period in 2023.

Marina Wolfson: In August of 24, we implemented a 1 to 10 reverse stop. This consolidated our outstanding shares without affecting the par value of the common stock, nor the authorized number of shares of common stock or preferred.

Speaker Change: In August of 'twenty, four we implemented a one to 10 reverse stock split.

This consolidated our outstanding shares without affecting the par value of the common stock noisy authorized number of shares of common stock preferred stock.

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

Speaker Change: Now, let's turn the call back over to Jonathan for his closing remarks Jonathan.

Jonathan Solomon: Jonathan. Thanks, Marina. In conclusion, the last quarter was comprised of key events, including the finalization of patient enrollment for the BX211 Phase 2 trial of DFO associated with Staphylococcus aureus, with a readout of top line results expected in the first quarter of 2025. For BX004, we add the opportunity to present our promising clinical data at key scientific conferences during the third quarter and revise our phase two top line readout timeline to the first half of 2026. We are confident in our phage pipeline's ability to address serious chronic infection and look forward to presenting some potentially life-changing data for DFO patients in the near future.

Jonathan: Thank you Marina in conclusion, the last quarter was comprised of key events, including the Finalization of patient enrollment for the <unk>. One one phase II trial of DSO associated with Staphylococcus aureus with a readout of top line results expected in the first quarter of 2025.

Jonathan: It would be example of four we had the opportunity to present, a promising clinical data at key scientific conferences during the third quarter and revise our phase II top line readout timeline through the first half of 2006, we are confident in our phage pipelines ability to address serious chronic infection and look forward to presenting some potentially life changing data for <unk> patients in the near future.

Jonathan Solomon: Thank you all for your participation this morning. Thank you.

Speaker Change: Thank you all for your participation this morning.

Speaker Change: Thank you we will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.

Unknown Executive: We'll now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. The confirmation tone will indicate your line is in the question queue.

Speaker Change: A confirmation tone will indicate your line is in the question queue.

Unknown Executive: You may press star 2 to remove yourself from For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment, please, while we poll for your questions.

Speaker Change: Press Star two to remove yourself from the queue for 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.

Speaker Change: Okay.

Joseph Pantginis: Our first questions come from the line of Joseph Pantginis with H.C. Wainwright. Please proceed with your question.

Speaker Change: Our first questions come from the line of Joseph Pan Janus with H C. Wainwright. Please proceed with your questions.

Sara Nik: Hi, this is Sara on for Joe. Thanks for taking the question. I was just wondering, regarding the manufacturing delay you mentioned for BX004, if there's any additional details or specifics you're able to provide on the delay and if whether this was just a one-off extenuating circumstance or not. And thank you for taking the question.

Hi, This is Sarah on for Joe. Thanks for taking the question I was just wondering regarding the manufacturing delay you mentioned could be extra look for if there's any additional details or specifics, we're able to provide on the delay in if we whether this was just a one off extenuating circumstance or not and thank you for taking the question.

Jonathan Solomon: Morning, and great question. So we do think and view it as a potentially one off one of the challenges that we had in gearing up for the larger phase two B study is just larger volumes. So far, we've manufactured 10 liters, this is like moving up to 50 liters. So there were some challenges and just calibrating all the system and the fade for 50 liters once that was set, kind of back on track. So I think that's where we feel very confident with the process that we have and the revised timeline.

Good morning.

Speaker Change: Great question.

Speaker Change: So we do think and view it as a potential one off one of the challenges that we had in gearing up for the larger.

Speaker Change: A phase <unk> study is just larger volumes. So far we've manufactured 10 leaders. This is like moving up to 50 leaders. So.

Speaker Change: So there were some challenges and just calibrating all the system and the fate for 50 leaders once that was set kind of back on track. So I think that's why we feel very confident.

Speaker Change: With the process that we have and the revised timeline.

Sara Nik: Okay, that's helpful. Thank you.

Speaker Change: Okay. That's helpful. Thank you.

Speaker Change: Yes.

Speaker Change: Thank you I'm showing no further questions at this time I'd like to hand, the floor back over to Jonathan Solomon for closing remarks.

Unknown Executive: I'm showing no further questions at this time.

Jonathan Solomon: I'd like to hand the floor back over to Jonathan Solomon for closing remarks. So thank you all again for participating, I wish you all happy holidays and we look forward to updating you on the data in the upcoming DSO study. Thanks again.

So thank you all again for participating I wish you all happy holidays, and we look forward to update you on our the data in the upcoming DSO study. Thanks again.

Speaker Change: Yeah.

Unknown Executive: Thank you.

Unknown Executive: 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: 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: Yeah.

Speaker Change: [music].

Speaker Change: Uh huh.

Speaker Change: [music].