Q2 2024 BiomX Inc Earnings Call
Speaker Change: Greetings and welcome to Biomics 2nd Quarter 2024 Financial Results Conference Call.
Speaker Change: At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation.
Speaker Change: 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.
Speaker Change: It is now my pleasure to introduce your host, Ms. Marina Wolfson, Chief Financial Officer. Thank you, Ms. Wolfson. You may begin.
Marina Wolfson: 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.
Marina Wolfson: 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.
Marina Wolfson: A replay of this call will also be available on the Investors section of our website.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: The Design, Recruitment, Aim, Expected Timing, and Interim and Final Results of our Preclinical and Clinical Trials.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: Joining me on the call this morning is our Chief Executive Officer, Jonathan Solomon, to whom I will now turn over the call.
Jonathan Solomon: Hi, everyone. Thank you for joining us on our earnings call. We're excited to discuss Bionic's status with you this morning.
Speaker Change: Early this year, the company took a momentous step in merging with Adaptive Phase Therapeutics, or APT, and completing a concurrent $50 million financing.
Speaker Change: Last month, we were delighted to update an important milestone with respect to this transaction.
Speaker Change: was met when her stockholders overwhelmingly voted in favor of the conversion of up to
Speaker Change: 256,000 series X non-voting convertible preferred stock issued upon the merger and concurrent financing to up to 256 million biomics common stock
Speaker Change: The Series X preferred stock was issued to certain APT shareholders and investors who participated in concurrent financing.
Speaker Change: 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.
Speaker Change: Subject to such beneficial ownership limitations to date, over a hundred thousand shares of Series X preferred stocks were converted to over a hundred million shares of the company's common stock that were added to the company's outstanding share count.
Speaker Change: 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 will review these anticipated readouts in just a moment.
Speaker Change: By integrating the two companies' programs, we believe we now have the leading phage-related pipeline in advanced clinical testing.
Speaker Change: Key to the strength of our combined programs is the diversity of our complementary approaches.
Biomics: At Biomics, we are developing six phage cocktails, which can target a broad host range of various bacterial strains and address multiple resistance mechanisms, allowing treatment of patients with the same phage cocktail.
Biomics: 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.
Biomics: The Biomics Pipeline demonstrates the diversity of our approaches. BX004, the company's novel six-stage cocktail, is advancing in development of treatment of serious chronic lung infection in cystic fibrosis patients, or CF patients, caused by Pseudomonas Arginosa.
Biomics: 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.
Biomics: As a quick recap, after only 10 days of treatment, 14.3% of patients in the BX004 arm of the Phase 1B2A study converted to sputum culture negative for pseudomonas aeruginosa compared to 0% of the patients in the placebo arm.
Biomics: 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.
Biomics: We expect to release top-line results from this study in the third quarter of 2025.
Biomics: 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.
Speaker Change: BXP1.1 is a personalized phase treatment currently being evaluated in a randomized double-blind placebo-controlled multi-center phase 2 trial for subjects with diabetic foot osteomyelitis or DFO, associated with staphylococcus aureus infection.
Speaker Change: The design of our ongoing phase 2 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.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: Overall, we are thrilled with the promising data already reported and with the key readouts we are anticipating from both of our lead programs.
Speaker Change: As Marina will review, based on the proceeds from the financing concurrent with the merger with ATP and existing capital, Biomx continues to expect to have sufficient funding to reach these multiple important clinical milestones, potentially driving significant value for our shareholders.
Speaker Change: Now, I will pass the call back to Marina, who will review Biomx financial results. Marina?
Marina Wolfson: 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 market close.
Speaker Change: I will take you through some of the highlights of our second quarter financial results.
Speaker Change: 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 30, 2023.
Speaker Change: 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.
Speaker Change: We estimate that our cash, cash equivalents, and short-term deposits are sufficient to fund our operations through the fourth quarter of 2025.
Speaker Change: 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.
Speaker Change: The increase was primarily due to preparations for Phase 2b in the clinical trial of our CF product candidate BX004 and expenses related to our clinical trial of the DFO product candidate BX211.
Speaker Change: In addition, the second quarter of 2024 represents the first full quarter following the merger with APT, incorporating the combined workforce. The increase is partially offset by higher grants received.
Speaker Change: 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.
Speaker Change: This increase primarily reflects the first full consolidation of expenses following the APT merger, reflecting the combined workforce, professional services, and subcontractor costs.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: And now, I'll turn the call back over to Jonathan for his closing remarks. Jonathan?
Jonathan Solomon: Thanks, Marina.
Jonathan Solomon: 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 have had the opportunity to present our promising clinical data at additional key meetings during the second quarter.
Jonathan Solomon: We are also continuing on track for our first major Phase 2 readout, with the expectation reporting initial top-line results for BX211 in the first quarter of next year. The recent stockholder vote for the conversion of preferred common stock is also part of this progress.
Jonathan Solomon: 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'll continue to keep you updated on our further progress.
Speaker Change: Thank you for joining us this morning. Operator, would you open the call for questions?
Speaker Change: Thank you. We will now be conducting a question and answer session.
Speaker Change: 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 2 if you would like to remove your questions from the queue.
Speaker Change: For participants using speaker equipment, it may be necessary to pick up a handset before pressing the start keys.
Speaker Change: One moment please, while we poll for questions.
Speaker Change: The first question comes from the line of Yale Gen with Laidlaw and Company. Please go ahead.
Yale Jain: Good morning, and thanks for taking the questions and congrats on all the progress.
Yale Jain: And maybe I'll just start a little bit with housekeeping questions that you have reported the this today that in terms of the
Avraham Gabay: Unknown Executive, Avraham Gabay
Avraham Gabay: Unknown Executive, Avraham Gabay
Speaker Change: for $1,000,000 as the basis or some other figures to calculate these numbers and then I have a follow-up question.
Speaker Change: Sure. So good morning, Yale. Always a pleasure. I'll let Marina handle the tough questions first, so let her do the responsibility.
Marina Wolfson: Thank you and good morning. Thank you for your question. So yeah, we're going to release the full calculations, obviously, and they are included in the note and our thank you. But yes, we took the full net income from the financial statement.
Speaker Change: And please note that we do have a net income this quarter for the captivation of the earnings per share.
Speaker Change: Okay, great. That's helpful. Maybe just one.
Speaker Change: And I think on the housekeeping side, which is the RV expenses of this quarter. Obviously, it's much higher. But given that's for a combined company.
Speaker Change: As you were guided at the runway to the end of the next year, so should we anticipate on the
Avraham Gabay: Unknown Executive, Avraham Gabay
Avraham Gabay: Yeah, that's an excellent question. 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
Speaker Change: you know, redundancies. And obviously, we do give guidance and we hold 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.
Speaker Change: Okay, great. And then I just have a question on the pipelines.
Speaker Change: in terms of 004.
Speaker Change: you indicated that the.
Speaker Change: Face2B trial will start in the third quarter of next year. So two things here. First one is that, are you guys expecting to have FDA meeting later this year or have this meeting already started or conducted? And secondly, was there any strategic plan?
Avraham Gabay: Unknown Executive, Avraham Gabay
Speaker Change: Another excellent question, so CF is on track, BX004 expected to report data 3rd quarter of 2025. We did have...
Speaker Change: The FTA 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.
Speaker Change: Okay, great. Maybe the last question is, in terms of 2.11, you could talk about the Facebook...
Speaker Change: I'm sorry, the top line, first quarter of next year, which is a 13 weeks data in terms of the change of the poster size.
Speaker Change: And after that, let's just assume that you have a positive outcome. What might be the next step? Was that waiting for the...
Speaker Change: 52-week outcome before you contemplate the next step, or you will have something in between after the readout of the 13-week data and the next.
Speaker Change: 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.
Speaker Change: I think the follow-up is more descriptive as we're looking at amputations, right? You require a lot more patience, but if we see a good signal in week 13
Speaker Change: Obviously, we'll have to talk to the agency and our partners and supporters.
Speaker Change: both investors as well as in the government.
Speaker Change: and we will want to kind of move forward for us. That's that is the gating item, right? What happens to week 13? I think we can learn more from what happens in the 26 and 52 weeks.
Speaker Change: Right, but but you know for us if you see something in week 13, it's as much as we can it's pedal to the metal
Speaker Change: Okay, great. That's very helpful and I'll get back to you.
Speaker Change: Sure. Great question. Thank you.
Speaker Change: Thank you. Next question comes from the line of Joseph Pankinish.
Speaker Change: with HCWayne by P-Squared.
Speaker Change: Hi, this is Sarah on for Joe. Thanks for taking the question. I just had a question regarding BX 211 enrollment if you can provide
Sarah: Any update on the status of enrollment in the study? Have you seen any challenges or is it progressing as expected now? Thank you.
Speaker Change: Thank you, Sarah, and good morning. Best to Joe. So, as we said, the study will be complete in the first quarter.
Speaker Change: 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 reading the study on time.
Speaker Change: Thank you very much.
Speaker Change: Thank you.
Speaker Change: Thank you. Next question comes from the line of Michael Higgins with Ladenburg-Thalmann. Please go ahead.
Farhana: 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.
Speaker Change: 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 and you know our plans remain unchanged moving forward.
Speaker Change: Thank you.
Speaker Change: Sure thing.
Speaker Change: Thank you. Next question comes from the line of Yale Gen with Laidlaw and Company. Please go ahead.
Yale Gen: Thanks for taking this question. I 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 2b study. Would you announce that
Yale Gen: when that happened.
Speaker Change: 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-person role, you know, something to consider.
Speaker Change: Okay, and maybe just a little bit follow-up in terms of 2-11, again, for the 13-week data. How do you consider a good...
Avraham Gabay: Unknown Executive, Avraham Gabay
Speaker Change: So, so in general, I think as we talk to the KOLs and the meta-analysis, you're looking for something like a 40% reduction of the placebo arm, right, because they're on top of standard of care antibiotics and something around a 70% on on the phage arm on top of antibiotics.
Speaker Change: will be exciting in our view, right? So, again, this is still a small study. We're not looking at StatSig. 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 percent, that's quite a dramatic move.
Speaker Change: And maybe lastly, just in terms, given just the 13 weeks.
Speaker Change: By the time of 52 weeks, which is about a year, would you anticipate the effect expanding or, you know,
Speaker Change: At that point, in other words, you know, could could achieve a different level of efficacy.
Speaker Change: 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
Avraham Gabay: Unknown Executive, Avraham Gabay
Speaker Change: 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.
Speaker Change: Right because in 11 out of 12 cases like phage treatment has prevented amputations
Speaker Change: 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.
Speaker Change: I will also note that we're looking at ulcer healing as exploratory 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.
Speaker Change: And maybe just tack on that a little bit more, is that do you anticipate or have you spoke with a consultant?
Speaker Change: whether amputation will be the kind of end point that ultimately for potential approval or just simply the other reduction as well as some other
Avraham Gabay: Unknown Executive, Avraham Gabay
Speaker Change: Yeah, so I think in a pivotal study the most conservative estimate is amputations, right? That's what you need like, you know, 300 patient study and do it properly
Speaker Change: there is talk about looking at, you know, you know, more imaging modalities, et cetera, and trying to be a bit more sophisticated, but conservatively, you know, it's applications, but potentially, you know, I think we'll work with all the experts to explore some other endpoints as well, of course.
Speaker Change: Okay, great. Again, thanks for taking the follow-up questions and congrats on all the progress. Maybe last one question here.
Speaker Change: This probably is for Maria. Marina, in terms of the reverse split,
Speaker Change: In the press release, you indicate that from 178 million shares back to about 17.8 million shares. Are these total share outstanding of the basic or that the fully diluted number?
Speaker Change: So thank you for the question. Actually I'm happy to clarify. So first of all please note that the reverse split is not reflected in the numbers of the queue.
Speaker Change: because it was only following the queue that we announced it. It will be effective August 26th. And the number of shares, the 178 million is just the outstanding. So that's not the fully diluted.
Speaker Change: Okay, great. That's very helpful. And again, congrats on the program.
Speaker Change: Thanks. Thank you.
Speaker Change: Thank you. As there are no further questions at this time, ladies and gentlemen, we have reached the end of the question and answer session. I would now like to turn the floor over to Jonathan Solomon for closing comments.
Jonathan Solomon: 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.
Jonathan Solomon: Thank you.
Speaker Change: This concludes our today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
Speaker Change: Abraham Gabay Matthew Gabay John Erin Gabay Wishaus gives the breath God gives his life for the condemned. The bitter words of the Messiah are like books of Liturgy. When you read the Holy Bible you cannot understand