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spk02: Greetings and welcome to Biomix second quarter 2024 financial results conference call. At this time all participants are in a listen only mode. A brief 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 keypad. As a reminder this conference is being recorded. It is now my pleasure to introduce your host, Ms. Marina Wolfson, Chief Financial Officer. Thank you, Ms. Wolfson. You may begin.
spk01: Thank you, and welcome to the Biomics Conference Call to review the second quarter 2024 financial results and provide an update on our business and program. Yesterday, we filed 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 biomics.com. A replay of this call will also be available on the Investor section of our website. 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 efficiency of the company's cash, 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 trials, the regulatory process and discussions with the FDA, the potential benefits and commercial opportunities of our product candidates, and the potential safety or efficacy of BX004 and BX211. In addition, past and current preclinical and clinical results, as well as compassionate use, are not indicative and do not guarantee future success of our clinical trials. 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, as noted earlier, is on our website. Joining me on the call this morning is our Chief Executive Officer, Jonathan Solomon, to whom I will now turn over the call.
spk05: Hi, everyone. Thank you for joining us on our earnings call. We're excited to discuss Bionic Status with you this morning. Earlier this year, the company took a momentous step in merging with Adaptive Phase Therapeutics, or APT, and completing a concurrent $50 million financing. Last month, we were delighted to update that an important milestone with respect to this transaction was met when our stockholders overwhelmingly voted in favor of the conversion of up to 256,000 Series X non-voting convertible preferred stock issued upon the merger and concurrent financing to up to 256 million Biomics Commons stock. The Series X preferred stock was issued to certain APT shareholders and investors who participated in the concurrent financing. As a result of the stockholder vote in favor, each share of Series X preferred stock issued converted into 1,000 shares of Biomics common stock, subject to certain beneficial ownership limitations set by certain investors. Subject to such beneficial ownership limitations to date, over 100,000 shares of Series X preferred stocks were converted to over 100 million shares of the company's common stock that were added to the company's outstanding share accounts. I'd like to now discuss why are we so excited about the clinical programs in our combined pipeline. As we previously announced, we expect to report important results for our two lead clinical assets in 2025. I'll review these anticipated readouts in just a moment. By integrating the two companies' programs, we believe we now have the leading phage-related pipeline in advanced clinical testing. Key to the strength of our combined programs is the diversity of our complementary approaches. At Biomics, we are developing six phage cocktails, which can target a broad host range of various bacterial strains and address multiple resistant mechanisms, allowing treatment of patients with the same phage cocktail. We are also developing personalized phage treatment that can address bacterial diversity and potentially polymicrobial infections, tailoring a specific phage treatment to a given patient. The Biomics pipeline demonstrates the diversity of our approaches. BX004, the company's novel fixed-stage cocktail, is advancing in development of treatment of serious chronic lung infection in cystic fibrosis patients, or CF patients, caused by pseudomonas arginosa. During the second quarter, we presented positive safety and efficacy results from the Phase 1 B2A trial of BX004, including at the 47th European Cystic Fibrosis Conference and the ASN Microbe 2024, both of which took place in June. As a quick recap, after only 10 days of treatment, 14.3% of patients in the BX004 arm of the phase 1 B2A study converted to sputum culture negative for pseudomonas aeruginosa compared to 0% of the patients in the placebo arm. BX004 versus placebo also showed signal of improved pulmonary function. We have entered into discussion with the US FDA regarding our next clinical trial for BX004 and are making progress in preparation for its initiation including completion of the remaining CMC work and finalizing Phase 2B study protocol. We expect to release top-line results from this study in the third quarter of 2025. For our second Advanced Clinical Candidate, BX211, we expect initial top-line results through Week 13 for the current Phase 2 trial in the first quarter of 2025. As most of you know, BX211 is our asset acquired through the merger with APT. BX211 is a personalized phage treatment currently being evaluated in a randomized double-blind, placebo-controlled, multicenter Phase II trial for subjects with diabetic foot osteomyelitis, or DFO, associated with staphylococcus aureus infection. The design of our ongoing Phase II study was guided in part by reports in the scientific literature of compassionate use of phage therapy, which showed positive outcome of wound healing and avoiding amputation in 11 of 12 patients. Both are lead programs we have continued to see and are grateful for the growing excitement among the clinical community. We are also grateful to our stockholders whose ongoing support has been vital for our efforts and has provided key validation for phage-based therapeutic modalities we are advancing into the clinic. We believe that both BX004 and BX211 have the potential to significantly change how we address the substantial unmet needs of patients with intractable infections. Overall, we are thrilled with the promising data already reported and with the key readouts we are anticipating from both of our lead programs. As Marina will review, based on the proceeds from the financing concurrent with the merger with ATP and existing capital, Biomics continues to expect to have sufficient funding to reach these multiple important clinical milestones, potentially driving significant value for our shareholders. Now, I will pass the call back to Marina, who will review Biomics' financial results. Marina?
spk01: Thank you, Jonathan. As a reminder, the financial information for the company's second quarter 2024 is available in the press release that we issued earlier today, as well as in more detail in our Form 10-Q, which we filed yesterday after markets closed. I will take you through some of the highlights of our second quarter financial results. As of June 30, 2024, cash balance, short-term deposits, and restricted cash were $32.7 million compared to $30.7 million as of June 30th, 2023. The increase was primarily due to our private placement financing of $50 million in March 24, which was partially offset by net cash used in operating activities and the full repayment of a debt facility. We estimate that our cash, cash equivalents, and short-term deposits are sufficient to fund our operations through the fourth quarter of 2025. Research and development expenses net total $6.9 million for the second quarter of 2024 compared to $3.8 million for the same period in 2023. The increase was primarily due to preparations for Phase IIb in the clinical trial of our CF product candidate, BX004, and expenses related to our clinical trial of the DFO product candidate, BX211. In addition, the second quarter of 2024 represents the first full quarter following the merger with APT, incorporating the combined workforce. The increase was partially offset by higher grants received. In the second quarter of 2024, general and administrative expenses were $2.8 million compared to $2.3 million during the same period in 2023. This increase primarily reflects the first full consolidation of expenses following the APT merger, reflecting the combined workforce, professional services, and subcontractor costs. Net income was $4.5 million for the second quarter of 2024, compared to a net loss of $6.4 million for the same period in 2023. The increase was mainly due to the change in the fair value of the warrants issued as part of the $50 million pipe financing in March 2024, partially offset by our expenses and operating activities. Net cash used in operating activities for the six months ended June 30, 2024, was $22.6 million, compared to $9.1 million for the same period in 2023. I should add here that we announced today a reverse stock split of 1 for 10 of the company's common stock, approved by the company's stockholders and the board of directors. The split is intended to become effective when the market opens on August 26, 2024. And now, I'll turn the call back over to Jonathan for his closing remarks. Jonathan?
spk05: Thanks, Marina. To sum up, we are excited to see our momentum in 2024 has continued through the second quarter and through the present. We have made great progress in integrating our programs following the merger with APT. And for BX004, we've had the opportunity to present our promising clinical data at additional key meetings during the second quarter. We are also continuing on track for our first major Phase II readout with the expectation of reporting initial topline results for BX211 in the first quarter of next year. The recent stockholder vote that the conversion preferred common stock is also part of this progress. We believe the company can reach our important clinical milestones on the current cash runway with the potential to build further value for our stockholders. We are dedicated to demonstrating the advantages of our diversified phage pipeline in addressing serious chronic infections. We continue to keep you updated on our further progress. Thank you for joining us this morning. Operator, would you open the call for questions?
spk02: 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. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your questions from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start keys. One moment please while we poll for questions. The first question comes from the line of Yale Gen with Laidlaw and Company. Please go ahead.
spk04: Good morning and thanks for taking the questions and the congrats on all the progress. And then maybe I'll just start a little bit with housekeeping questions that you have reported today that in terms of the earning per shares as well as both of the fully diluted and the basic count. I just want to get a little bit color in terms of how was that calculated? Was that used as net income of $4.4 million as the basis or some other figures to calculate these numbers? And then I have a follow-up question.
spk05: Sure. So, good morning, Yale. Always a pleasure. I'll let Marina handle the tough questions first. Let her do the responsibility.
spk01: Thank you, and good morning. Thank you for your question. So, yes, we're going to release the full calculations, obviously, and they are included in the note in our thank you. But, yes, we took the full net income from the financial statements. And please note that we do have a net income this quarter for the calculation of the earnings per share.
spk04: Okay, great. That's helpful. Maybe just one thing on the , which is the R&D expenses of this quarter. Obviously, it's much higher, but given that's for a combined company, as you was guided that the runway was to the end of the next year, so should we anticipate R&D expenses over the next few quarters probably at least for the remaining of this year uh will be trending down and so you'll be able to achieve the goal in terms of the cash runway yeah that's an excellent question and you're very keen to observe it that's very true this is the first time that we're operating we're still implementing all the um you know redundancies and and obviously
spk05: We do give guidance and we hold you behind it, but the cash runways until the end of next year. So accordingly, you know, you'll see kind of a budget trying to, you know, reducing in terms of burn.
spk04: Okay, great. And then I just have a question on the pipeline. In terms of 004, you indicated that the phase 2b trial was starting third quarter. of next year. So, two things here. First of all, is that are you guys expecting to have FDA meeting later this year or are these meetings already conducted? And secondly, was there any strategic reasons that this one seems to be pushed out a little bit in comparison to prior sort of thoughts or estimates from our staff? And thanks.
spk05: Yeah, yeah. So, yeah, another excellent question. Another excellent question. So CF is on track. BX004 expected to report data third quarter of 2025. We did have the FDA meeting. It was a successful meeting, and I think we are moving ahead with we haven't seen any limitation to the original plan. So that's on track.
spk04: Okay, great. Maybe the last question here is in terms of 211, you talked about the Facebook I'm sorry, the top line first quarter of next year, which is a 13 weeks data in terms of the change of the author's size. And after that, let's just assume that you have a positive outcome. What might be the next step? Was that waiting for the 52 weeks outcome before you have contemplated the next step? or you will have something in between the readout of the 13-week data and the effects?
spk05: So our view is that the 13-week data is the more important data because the study is powered to look at a shrinkage of the ulcer site at that point. I think the follow-up is more descriptive as we're looking at amputations, right? You require a lot more patients, but if we see a good signal in week 13, Obviously, we'll have to talk to the agency and our partners and supporters, both investors as well as from the government, and we will want to kind of move forward. For us, that is the gating item, right, what happens in week 13. I think we can learn more from what happens in the 26th and 52 weeks, right? But, you know, for us, if you see something in week 13, as much as we can, it's a pedal to the metal.
spk04: Okay, great. That's very helpful, and I'll get back to you.
spk05: Sure. Great question. Thank you, Jay.
spk02: Thank you. Next question comes from the line of Joseph Pankinus with HCV Invite. Please go ahead.
spk03: Hi, this is Sarah on for Joe. Thanks for taking the question. I just had a question regarding BX211 enrollment, if you can provide Any update on the status of enrollment in the study? Have you seen any challenges, or is it progressing as expected now? Thank you.
spk05: Thank you, Sarah, and good morning. Best to Joe. So, as we said, the study will be complete in the first quarter. Obviously, overall, this has been a challenging study to recruit, right, spanning over more than two years. We didn't get specific guidance on the status of enrollment. I mean, we've kind of passed the majority of patients and, you know, kind of look forward to giving the study on time.
spk03: Okay. Thank you very much.
spk02: Thank you. Thank you. Next question comes from the line of Michael Higgins with Ladenburg-Thalman. Please go ahead.
spk00: Good morning. This is Farhana on behalf of Michael. I just wanted to follow up on your comment on BX004's FDA meeting. Any feedback that you can share with us? Thank you.
spk05: Thank you, and good morning. Obviously, it's a sensitive, so we need to be very careful about what we can provide. But all I can say is that it was a successful meeting, and, you know, our plans remain unchanged moving forward.
spk00: Thank you.
spk02: Sure thing. Thank you. Next question comes from the line of Yale Gen with Laidlaw and Company. Please go ahead.
spk04: Thanks for taking this question. I'd just like to get a little bit more color in terms of a 004 when you may be enrolling the first patient for the Phase IIb study. Would you announce that when that happens?
spk05: Yeah, traditionally we didn't announce. I think that was, we just kind of, you know, there was something dramatic. So we traditionally didn't announce, but we can look into it. So far, kind of moving ahead according to plan. We didn't usually have first patient enrolled, you know, something to consider.
spk04: Okay, and maybe just a little bit follow-up in terms of 211, again, for the 13 weeks data. What do you consider as a good outcome in terms of the reduction of ulcer size and that will propel you guys to think more aggressively to move the program forward and thanks so so in general i think as we talk to the kols and the men analysis you're looking for something like a 40 reduction of the placebo arm uh right because they're on top of standard of care antibiotics and
spk05: Something around a 70% on the phage arm on top of antibiotics will be exciting in our view, right? So, again, this is still a small study. We're not looking at stat sig. I think we'll be interested in trends. But if you see something like that, then I think that could be, you know, something that we'll be excited about. These patients don't, you know, usually improve that much. So you see something along – that pushes it like by, you know, 30%, that's quite a dramatic move.
spk04: And maybe lastly, just in terms, given this is a 13 weeks data, do you, by the time of 52 weeks, which is about a year, would you anticipate the effect expanding or, you know, at that point, in other words, you know, could achieve a different level of,
spk05: uh efficacy so so i think the 26 and to your point the 52-week data is mostly about amputations right that's really what again right patients want the ulcer to heal but what we really care about is the amputations and that's what we'll be looking at week 52. um the challenge is that you know again amputations you need a much bigger number of patients to see much of an effect So I think we'll be looking at sort of like, you know, general, you know, high-level trends if something's happening there. The data from the Compassion use, I must say, was very exciting, right? Because in 11 out of 12 cases, like, phage treatment has prevented amputations. But, you know, I think we want to be cautious in our guidance. So we'll look at amputations. I think that's where we're focusing on week 13. That's where the data is. I will also note that we're looking at ulcer healing as exploratory and in week 13 because that's also an indication usually when the ulcer heals that the infection has been resolved at the bone, right? So we'll look into it. But again, studies powered for ulcer shrinkage and everything else will be a bonus.
spk04: And maybe just tack on that a little bit more is that do you anticipate or have you spoke with a consultant whether amputation will be the kind of endpoint that ultimately for potential approval or just simply the other reduction as well as other metrics will be potentially sufficient for the approval in this indication, which is obviously tough to treat and very few drugs have been available for this.
spk05: Yeah, so I think in a pivotal study, the most conservative estimate is amputations, right? That's where you need like, you know, 300 patients study and do it properly. There is talk about looking at, you know, more imaging modalities, et cetera, and trying to be a bit more sophisticated. But conservatively, you know, it's amputation, but potentially, you know, I think we'll work with all the experts to explore some other endpoints as well, of course.
spk04: Okay, great. Again, thanks for taking the follow-up questions and congrats on all the progress. Maybe last one question here. This is probably for Marina. In terms of the reverse split in the press release, you indicated that from 178 million shares back to about 17.8 million shares, are these total
spk01: share outstanding of the basic or that the fully diluted number uh so thank you for the question actually i'm happy to clarify um so first of all please note that the reverse split um is not reflected in the numbers of the queue because it was only following the queue that we announced it it will be effective at least 26 and the And the number of shares, the 178 million, is just the outstanding. So that's not the fully diluted.
spk04: Okay, great. That's very helpful. And again, congrats on the progress. And thanks. Thank you.
spk02: Thank you. As there are no further questions at this time, ladies and gentlemen, we have reached the end of question and answer session. I would now like to turn the floor over to Jonathan Solomon for closing comments.
spk05: So I wanted to thank all of you again for joining us this morning and the great questions. We look forward to providing you with additional updates as we make progress. Thank you and have a good day.
spk02: Thank you. This concludes our today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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