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spk02: Good morning and welcome to the Biomix first quarter 2022 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 would now like to turn the call over to Marina Wilson, Chief Financial Officer of Biomix. Please proceed.
spk01: Thank you and welcome to the Biomix first quarter 2022 financial results and corporate update conference call. The news release became available just after 6.30 a.m. Eastern Time today and can be found on our website at biomics.com. A replay of this call will be available on the Investors 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 historic statements may be deemed forward-looking statements. For instance, we're using forward-looking statements when we discuss on the conference call potential market opportunities, the design, aim, expected timing, interim and final results of our preclinical and clinical trials, the sufficiency of our existing cash, cash equivalents, and short-term deposits, our capitalization, the potential receipt of additional cash if milestones are met, the potential benefits of our product candidates, and potential growth in shareholder value. Except as required by law, we did not undertake to update forward-looking statements. The full Safe Harbor provision, including risks that could cause actual results to differ from these forward-looking statements, are outlined in today's press release, which, as noted earlier, is on our website. Joining me on the call this morning is Jonathan Sellerman, Chief Executive Officer of Biomics. With that, I will turn the call over to Jonathan.
spk03: Thank you, Marina, and good morning, everyone. Having recently released our 2021 annual report, our first quarter update will have limited new information over what we reported just a few weeks ago on our fourth quarter conference. So I intend to keep the remarks brief on this call and reserve more time for the question and answer session. I'd like first to provide an update on BX004, which is being developed for the treatment of chronic respiratory infections in patients with cystic fibrosis, or CF. At present, we are working actively to enroll patients in the Phase 1b-2a trial, and we continue to expect initial data from the Phase 1b portion of the trial in the third quarter of 2022. As noted in our prior update, our CEA program is being supported through a therapeutic development award from the Cystic Fibrosis Foundation, an organization that has been instrumental in supporting the development of so many life-saving medicines for cystic fibrosis patients. We are also very excited to announce that tomorrow, May 12th, BioNIC will host a KOL webinar to discuss the treatment landscape for CF patients with chronic lung infections and the potential of BX004 to address patients with chronic pseudomonas aeruginosa infections. The first part of the event will feature prominent CF clinicians who will review the current treatment modalities and the unmet medical need in treating cystic fibrosis patients with chronic pseudomonas aeruginosa infections. Following the KOL presentations, Biomics will present its phage therapy, BX004, as a potential treatment solution providing a review of phage candidates' preclinical activity and an overview of the ongoing clinical development plan. Let me now briefly turn to BX005 program, which is being developed for the treatment of atopic dermatitis. I am happy to report that in April 2022, the FDA cleared the IND application for atopic dermatitis candidate BX005. BX005 has been designed to restore the skin microbiome composition of AB patients back to its pre-flare state by reducing staphylococcus aureus burden, a bacteria associated with exacerbating inflammation in this particular skin condition. We anticipate initial data from our Phase I-II proof-of-concept trial in the fourth quarter of 2022. I'd now like to turn the call over to Marina Wolfson, our Chief Financial Officer, to cover our financial results for the first quarter.
spk01: 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-Q, which will be filed later today. I will walk you through some of our brief highlights. As of March 31, 2022, cash balance and short-term deposits were $55.7 million compared to $63.1 million as of December 31, 2021. The decrease was primarily due to net cash used in operating activities. Research and development expenses net were $4.9 million for the three months ended March 31, 2022, compared to $5.7 million for the same period in 2021. The decrease was primarily due to pauses in the development of BX003, the product candidate for the treatment of inflammatory bowel disease and primary sclerosing cholangitis. pauses in the development efforts in the colorectal cancer program, as well as the discontinuation of BX001, the product candidate for the treatment of acne. In addition, the decrease in R&D expenses was due to an increase in grants from the Israeli Innovation Authority, offset by an increase in expenses related to conducting preclinical and clinical trials of our CF and AD product candidates, BX004 and BX005, respectively. There was no material change to general and administrative expenses that impacted earnings for the three months ended March 31st, 2022 compared to the same period in 2021. Net loss was $8.2 million for the first quarter of 2022 compared to $8.4 million for the same period in 2021. Net cash used in operating activities was $7.4 million for the three months ending March 31, 2022, compared to $6.4 million for the same period in 2021. We estimate that existing cash, cash equivalents, and short-term deposits will be sufficient to fund the company's current operating plan through the end of 2023. Additional tranches that will become available to the company under its venture debt facility upon satisfaction of certain specified milestones can further extend the company's cash runway through the first half of 2024. And now I'll turn the call back over to Jonathan for his closing remarks. Jonathan?
spk03: Thank you, Marina. With a good balance sheet and a proof-of-concept data expected within the next 12 months in both our cystic fibrosis and atopic dermatitis program, Biomics is entering an exciting period where we aim to demonstrate positive proof-of-concept data in areas of significant unmet medical needs. Either one of these readouts, if positive, will represent a watershed moment for our company, clinical validation of our technology platform, and the creation of significant value for our shareholders. We thank you for your continued support, and at this time, we'd like to open up the call for questions.
spk02: Operator? And at this time, we'll be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question 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 questions. Our first question comes from the line of Kristen Kliska with Cancer Fitzgerald. Please proceed with your question.
spk05: Hi, good morning and good afternoon, everybody. Thanks for choosing my questions. So we've seen the AMR Act deploy more funds recently to the space. So big picture, could you talk about the potential for seeking some non-diluted funds in the future from some of these initiatives in addition to what you already have in place with, for example, CFF? And when do you think pharma in the space is going to put a larger emphasis on AMR and the problems that we're seeing in general?
spk03: Good morning, Kristen. Excellent question, as always. And, you know, finally some good weather in New York. So I think it's what we're seeing is the beginning, right? I think the AMR investment in APT is a great step forward. I think, you know, we're in close contact with AMR. And I think what's unique in APT is some of the compassionate use that they've been participating that gives people comfort on phage modality, right? We've seen, to your point, The BioNTech deal with Phagomed, kind of interest in bacterial vaginosis and an endolysis technology. So I think we're starting to see kind of the cards turn and more and more interest in the field. We're also, you know, if you look at, you know, BARDA that has put significant amount in the likes of, you know, Vedanta and Contrafect with technologies for bacteremia, again, you know, in the microbiome field. So there's definitely more momentum there, and I think we plan on leveraging that. But to your point, I think what Pharma wants to see is a proof-of-concept study, right? I think with phage technology, there's a lot of anecdotal data that looks very promising, right? In CF, we have 11 patients, now actually more, but at least 11 patients that were published that had significant effect. I think where Pharma will really move forward is when they see a POC of, you know, randomly controlled study that is showing significant effect of reducing target bacteria and some clinical effect. And, you know, with biomics, we hope to have that in the next 12 months.
spk05: Great. Thank you for that. And can you remind us about some of the work you're conducting to potentially go after pediatric patients with phage? And then to an extent, most of these compassionate yeast studies we've seen have primarily been in adolescents and adults. So What, if any, key differences might you expect with this patient demographic and the approach with phage?
spk03: I think you're right. I mean, for us, the pediatric angle would be interesting in indications such as atopic dermatitis, right, because of the safety profile. But I think it's not what we want to do initially, right? NCF, which is also composed of a pediatric population as well as an adult population, right, Initially, we start with adults in a topic. Initially, we'll start with mild to moderate just based on, you know, the work that comes out of UCSD. But I think because of the phage safety profile, pediatric population is definitely the population to pursue after that. And I think that's some of the surveys and KOLs that we talked to express a lot of interest in finding, you know, approaches which are safe and topical in, you know, the likes of topic therapy.
spk05: Okay, great, thanks. Looking forward to your webinar tomorrow.
spk03: Thank you.
spk02: And again, as a reminder, if anyone has any questions, you may press star one on your telephone keypad to join the queue. Our next question comes from the line of Fotana Blacklock with Lattenburg-Dalman. Please proceed with your question.
spk04: Hi. Hi, I'm Fotana on behalf of Michael. We have three questions. So the first is, are you pursuing any partnerships for 004 and 005 outside of the one that you already have in Japan?
spk03: Hi, Fontana. Good morning. I think currently it kind of goes back to where Kristen mentioned. I think there are some discussions with a few potential foreign partners. I think we're very excited to have Maruhu jump in early for partnerships. I do suspect that the more meaningful partnerships will come when we get these POC data, right? So I think that's kind of what I want to see. There's been obviously early investment in the company by J&J and Takeda, but I think now it's showtime, and we need to show some POC data.
spk04: All right, thanks. And the second question is, so for 004, like, there was a bit of a delay. Like, the enrollment was slow. How's that going now?
spk03: Right. So I think we've, you know, and a month ago we've announced a delay in the CF program. I think we're seeing kind of slowing up in the sites with the Omicron surge in the sites. Now things are looking good. So we're cautiously optimistic. We're keeping the same guidance, you know, kind of working hard and tapping into additional sites and getting good receptions from the, you know, from the patients. So I think there's cautious optimism on the team that we're going to maintain the timeline. and provide the data.
spk04: Okay, that's great. And just one last question. With 005, when does the enrollment start, and are you expecting any kind of, I guess, COVID-related effects on this trial as well?
spk03: It's a very good question. I think we haven't disclosed any additional detail beyond the fact that the IND was cleared, which is great news for us. Since this is a topical administration of population which is not very compromised, we don't have You don't expect any delays, and we're keeping the guidance that we originally gave on data at the end of this year.
spk04: Okay, great. Thank you for taking my questions.
spk03: You bet. Excellent questions. Thank you.
spk02: And we have reached the end of the question and answer session, and I'll now turn the call back over to Jonathan Solomon for a closing remark.
spk03: So thank you all again for joining us this morning. We look forward to providing you with future updates on our clinical programs throughout the next year. Have a wonderful day, and please reach out to us if you have any questions. Thank you.
spk02: And this concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.
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