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spk02: Good morning and welcome to the Biomex second quarter 2023 financial results and corporate update conference call. Currently all participants are on 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 Wolfson, Chief Financial Officer of Biomex. Please proceed.
spk01: Thank you and welcome to the Biomex second quarter 2023 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, and interim and final results of our preclinical and clinical trials, the next stages in development, the sufficiency of our existing cash, cash equivalents, and short-term deposits, the potential benefits of our product candidates, the expected benefits from FDA fast-track designation, and potential growth in shareholder value. In addition, past preclinical and clinical results, as well as compassionate use, 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 differ from these forward-looking statements, are outlined in today's press release. which is 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.
spk05: Thank you, Marina, and good morning, everyone. I am pleased to report that we continue to make significant progress in our BX004 program. We are delighted to update that patient screening for Part 2 of our Phase 1 B2A study has been completed with patient enrollment expected to exceed original estimates, reflecting solid execution by our clinical operations team, along with a growing awareness among physicians and patients within the cystic fibrosis community and the potential of this innovative program. I'm also pleased to announce that BXL-004 has just received FASTRAC designation from the FDA which provides further recognition that the BX004 program is addressing one of the most serious and challenging unmet medical needs facing the CF community. The FDA defines addressing a significant unmet medical need as providing a therapy when none exists or providing a therapy which may be potentially better than available therapies. The benefit of fast track designation includes but are not limited to early and frequent communication with the FDA throughout the entire drug development and review process. In addition, FASA designation means that BX004 may also be eligible for rolling submission and prior review of biological license application and or new drug application, which assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients. As a reminder, BX004 is being developed for the treatment of chronic pseudomonas aeruginosa, or PSA, pulmonary infections in patients with cystic fibrosis. In February 2023, we announced positive results from Part 1 of the trial, which came in better than expected based on the treatment arm displaying notable reductions in PSA bacterial burden. Following this announcement in June, we had the opportunity to formally present these data during the late-breaking session at the 46th European Cystic Fibrosis Conference, or the ECFC, which is an important international conference that attracts a wide audience of CF thought leaders, advocacy groups, and patients. I can say unequivocally that physicians were excited with the notable reduction in bacterial burden displayed in Part 1 of our study that we came away from the eCFC meeting with the impression that chronic PSA pulmonary infections continue to pose a challenging, unmet need for CF patients today. We therefore believe that BX004 is one of the few and most promising early clinical candidates for treating these infections in CF patients. With our patient screening efforts now complete, we estimate a four to six week delay in our top line results for part two of the study, now expected to be announced in November of this year. Under the part two study design, at least 24 CF patients received BX004 twice a day, but over a longer 10-day treatment period compared to part one. Similar to part one, results from part two are intended to provide additional data on safety and reduction in PSA bacterial burden, along with other exploratory endpoints. Assuming positive results from this larger CF study group, we anticipate holding a meeting with the FDA to plan the next stage of BX004's clinical development. In addition, in May 2023, we announced the second closing of a $7.5 million private placement, or the PIPE, with a select group of institutional and individual investors, which provided additional funding to support the BX004 program and other R&D activities. We also added two highly accomplished pharmaceutical executives to our board who collectively bring to Biomic's considerable business and legal experience. In summary, we are very pleased with the continued progress in the BX004 program. The feedback we're receiving from physicians, patients, and other stakeholders within the CF community has been highly positive and constructive, reinforcing our view in the therapeutic potential of BX004 to treat life-threatening infection CF patients are facing. I'd like now to turn the call to Marina to review our financial results for the second quarter of 2023.
spk01: Thank you, Jonathan. As a reminder, the financial information is available in the press release we issued earlier today, and also, and 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 June 30, 2023, cash balance and short-term deposits were $30.7 million, compared to $34.3 million as of December 31, 2022. The decrease was primarily due to cash used in operating activities, partially offset by proceeds we received from the PIPE financing. Research and development expenses net were $3.8 million for the three months ended June 30, 2023, compared to $4.6 million for the same period in 2022. The decrease was primarily attributed to several factors, a decrease in both salaries and stock-based compensation expenses, which resulted from a reduction in workforce as part of a corporate restructuring in 2022, as well as deprioritizing preclinical and clinical activities related to our atopic dermatitis product candidate, BX005. Additionally, we received higher proceeds from collaboration agreements. However, this decrease in R&D expenses net was partially offset by expenses related to conducting the clinical trial of our CF product candidate, BX004. General administrative expenses were $2.3 million for the three months ended June 30, 2023, compared to $2.4 million for the same period in 2022. The decrease was primarily due to a reduction in the company's director's and officer's insurance premium. Net loss was $6.4 million for the second quarter of 2023, compared to $7.5 million for the same period in 2022. Net cash used in operating activities was $9.1 million for the six months ended June 30, 2023, compared to $16.4 million for the same period in 2022. We estimate the existing cash, cash equivalents, and short-term deposits will be sufficient to fund the company's current operating plan into the third quarter of 2024. And now, I'll turn the call back over to Jonathan for his closing remarks. Jonathan?
spk05: Thank you, Marina. During the first half of 2023, we made significant progress in advancing our BX004 program. This momentum is already carried through into the second half of 2023, with the FDA granting BX004 fast-track designation and the completion of patient screening in Part 2 of our Phase 1 B2A trial. The Part 1 results were clearly better than we had expected, and our positive view on BX004 was further reinforced based on supportive feedback from this year's ECFC meeting. Our attendance at ECFC also served as a poignant reminder that thousands of CF patients are in dire need of new treatment approaches to combat these pervasive and deadly PSA infections. Based on our promising results thus far, we believe BX004 is emerging as a potential viable therapeutic candidate to address the significant unmet medical need in CF. With that, Marina and I are now happy to take any questions. Operator?
spk02: Thank you. The floor is now open for questions. If you would like to ask a question, please press star one on your telephone keypad at this time. 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 the handset before pressing the star keys. Again, that's star one to register questions at this time. Today's first question is coming from Joe Pantingenes of HC Wainwright. Please go ahead.
spk03: Hi, Jonathan and Marina. Thanks for taking the question. So first, on 004 for CF, on the Part 2 data, I guess I want to understand some of the logistics around data. And I guess, you know, does it have to do with, you know, exceeding the enrollment, particular endpoints that require, you know, additional time for analysis? How should we be looking at that? And then also, can you give a sense of, you know, how many patients beyond the expected enrollment you hit?
spk05: Joe, good morning. All excellent questions. So as you mentioned, basically enrollment and patient recruitment went a lot better than we expected. It's driven, I think, by a few factors. There's excitement from the Part 1 data. I think there's been very good execution from the team. So we literally opened centers and got more patients than we anticipated. And that sort of sped into, you know, it's not that anything has changed, no endpoints has changed, not everything sort of is going according to plan, just more patients. There is, as you noted, a slight delay. It's driven. There are more patients that are going through, you know, kind of the pipeline and some operational issues, nothing major. At this point, we're not giving guidance on the exact number of patients. Crossing our fingers, we want to sort of increase the number. I think that helps us in, you know, getting more data and thinking about the next studies, right? So I think that would be fantastic and, you know, again, excited. You remember all the difficulties we've had with recruiting part one and the delay. This is going very, very well in part two. It's a very different world.
spk03: No, I appreciate that color. And then, look, my next question is certainly forward-looking, and I'll preface it by saying, you know, the answer could change five minutes from now. But when you look at your upcoming discussions with regulatory authorities for, you know, looking at studies beyond Part 2, what does your current wish list look like as to, you know, what a clinical program might look like to get to the market as quick as possible pending positive data?
spk05: Right. So, we're definitely, you know, it's a tough and another good question, right? I think we've got the FAST-TRACK designation. That's already a step in the right direction. You know, there's more items that we'd want to pursue, such as ORFN, breakthrough, and hopefully accelerated approval, right? So, I think those are all conditioning on the data that we see in the discussion with the FDA. I think we've seen cases of FAST approval, such as with the accelerated approval. And there's cases with smart design. So I think anything that gets us to a product faster and serves the unmet need, which we're seeing is what we're looking for. And again, there's going to be a lot of meat on the bone for the discussion. I think the fast track is sort of a first signal that the FDA acknowledges the huge unmet need, sort of like opening up more channels for discussion.
spk03: No, I appreciate that. And then if I could just ask, and thank you for indulging me, other than the obvious answer of resources, are there other potential avenues to be able to sort of reignite pipeline assets?
spk05: You're always welcome to ask more questions, right? I think we all, as you know, right, we set up the company to be a platform company and Um, you know, we are looking at a bunch of other, uh, projects such as the topic and others that we're looking that are now, um, kind of waiting for more resources. So I do think that if part two looks as good as part one. Right. Then, then there's a second independent replication of a randomly controlled study with phase with placebo that is showing an effect. Right. I think that that would give us and hopefully others. the confidence that we've got a good handle on this new modality. And I think that could open up multiple panels for discussions, right, because there's more indications, there's more we can do. And with phage, you can move relatively quickly, you know, to the clinic with additional programs. But, again, it requires definitely additional resources or collaborators.
spk03: Thank you, Jonathan.
spk05: Pleasure as always.
spk02: Thank you. Once again, it's Star 1 if you would like to register a question. The next question is coming from Michael Higgins of Ladenburg-Fallman. Please go ahead.
spk04: Thanks, operator. Good morning, guys. Good afternoon. Thanks for taking the questions and congrats from us as well on the FAST-TRACK designation. I want to poke back a bit on the delay of data with additional patients from here in Q3 to November. Just want to clarify for ourselves and everyone how much of this data you've been able to review along the way. or has there been a review by the CRO along the way? Thanks.
spk05: Yeah. So, I mean, we're completely blinded to the data. So, we haven't, you know, we haven't seen anything or if we make any decision. I think what we've seen is some of the, you know, sort of excitement among the sites. And what we're seeing is more patients that have been referred by the centers and more patients kind of passing through the screening. than we originally anticipated, and the decision that we took that, you know, the more the merrier, so long as it's only a slight delay, because as I mentioned before, I forgot to say good morning, but Michael, I think as we talked before, right, we know this is a new modality, and the more data we get, the better we're prepared, both for discussion with the agency, as well as design of the next clinical study.
spk04: Yeah, it definitely helps to have more patients ahead of the pivotal start. Question for you on the next steps. Do you need to have the six-month safety data in hand before your end of phase two meeting with the FDA?
spk05: It's a great question. I think the estimate is that no. I think we know, you know, so far we've felt very comfortable and the FDA has sort of held public workshops on phase sort of acknowledging the safety of the modality. So I think it's sort of a soft follow-up.
spk04: uh in the part two and hopefully i think we'll see from the information that we had at day 28 should be sufficient to kind of get the discussion going and uh one last one if i could here before i jump back in the queue and maybe come back in with another question later but um we saw additional phase 1b data ecfc including baseline information is there additional information that you plan to share uh such as is there any data past the 15-day endpoint Any plans, if so, to share that, please?
spk05: So we haven't looked at the design. I mean, as you recall, Part 1 was mostly a short safety study to kind of pave the way for the Part 2, so we don't have longer follow-ups. There's a bit more information that we're kind of wrapping up that hopefully we can present at a conference. But, you know, the heavy lifting and I think most of the information will be at the Part 2 for sure and longer follow-ups. I appreciate it. Thanks, guys. You bet, Dr. Michael.
spk02: Thank you. At this time, I'd like to turn the floor back over to Mr. Solomon for closing comments.
spk05: So, I want to say thank you again for joining us this morning. We look forward to providing you with future updates on our clinical programs in the new year. Have a wonderful day and please reach out to us if you have any questions. Thank you again.
spk02: Ladies and gentlemen, thank you for your participation. This concludes today's event. You may disconnect your lines or log off the webcast at this time and enjoy the rest of your day.
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