BiomX Q2 2024 Earnings Report

BiomX EPS Results

• Actual EPS: $13.30
• Consensus EPS: -$22.80
• Beat/Miss: Beat by +$36.10
• One Year Ago EPS: N/A

BiomX Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

BiomX Announcement Details

• Quarter: Q2 2024
• Date: 8/14/2024
• Time: N/A
• Conference Call Date: Thursday, August 15, 2024
• Conference Call Time: 8:00AM ET

BiomX (NYSEAMERICAN:PHGE) is a clinical-stage biotechnology company that specializes in developing precision bacteriophage therapies to target pathogenic bacteria in the human microbiome. By harnessing the natural ability of bacteriophages to selectively infect and lyse harmful bacterial strains, BiomX aims to restore microbial balance without disrupting beneficial commensal organisms. The company’s platform integrates phage discovery, formulation and genetic engineering to create tailored phage cocktails for a range of microbiome-associated diseases.

The company’s pipeline includes lead clinical candidates for gastrointestinal disorders such as pouchitis and ulcerative colitis, as well as programs addressing dermatological indications including acne and atopic dermatitis. Preclinical studies have demonstrated the ability of BiomX’s phage preparations to reduce targeted bacterial populations implicated in inflammation and disease progression. Advanced product characterization and manufacturing processes support both oral and topical delivery formats, positioning BiomX to advance multiple candidates through regulatory pathways.

Founded in 2016 as a spin-out from MIGAL – Galilee Research Institute, BiomX is headquartered in Rehovot, Israel, with a U.S. presence in Cambridge, Massachusetts. The company conducts clinical trials across North America and Europe, collaborating with academic medical centers and contract research organizations. Since its initial public listing on the NYSE American exchange under the ticker PHGE, BiomX has expanded its leadership team to include executives with deep expertise in phage biology, clinical development and biomanufacturing. The company’s research and development efforts are overseen by CEO Eliora Ron, who guides strategic initiatives to translate microbiome science into targeted, next-generation therapies.

BiomX Q2 2024 Earnings Call Transcript

Key Takeaways

• Merger and Financing: Completed merger with Adaptive Phase Therapeutics and a concurrent $50 million financing, with stockholders approving conversion of up to 256 million Series X preferred shares into common stock.
• BX004 Phase 1b/2a Success: In cystic fibrosis patients, 14.3 % of treated subjects cleared Pseudomonas aeruginosa versus 0 % on placebo and showed improved pulmonary function; preparing Phase 2b study with topline results expected in Q3 2025.
• BX211 Phase 2 Readout: Personalized phage therapy for diabetic foot osteomyelitis is in a randomized, placebo-controlled Phase 2 trial, with week 13 efficacy data anticipated in Q1 2025.
• Funding Runway: Ended Q2 with $32.7 million in cash and equivalents (up from $30.7 million year-ago) and expects current capital to fund operations through Q4 2025.
• Corporate Actions: R&D and G&A expenses rose due to merger integration and trial preparations, and a 1-for-10 reverse stock split will become effective August 26, 2024.

Presentation

[Operator]

...Greetings, and welcome to BiomX's 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.

[Marina Wolfson, CFO at BiomX]

Thank you, and welcome to the BiomX conference call to review the second quarter 2024 financial results and provide an update on our business and programs. 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 biomx.com. A replay of this call will also be available on the investors 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.

[Marina Wolfson, CFO at BiomX]

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, aims, 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.

[Marina Wolfson, CFO at BiomX]

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.

[Jonathan Solomon, CEO at BiomX]

Hi, everyone. Thank you for joining us on our earnings call. We're excited to discuss BiomX status with you this morning. Early this year, the company took a momentous step in merging with Adaptive Phage 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 BiomX common stock. The Series X preferred stock was issued to certain APT shareholders and investors who participated in the concurrent financing.

[Jonathan Solomon, CEO at BiomX]

As a result of the stockholder vote in favor, each share of Series X preferred stock issued converted into 1,000 shares of BiomX 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 count. 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.

[Jonathan Solomon, CEO at BiomX]

Key to the strength of our combined programs is the diversity of our complementary approaches. At BiomX, 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. BiomX pipeline demonstrates the diversity of our approaches. BX004, the company's novel six-phage cocktail, is advancing in development of treatment of serious chronic lung infection in Cystic Fibrosis patients, or CF patients, caused by Pseudomonas aeruginosa.

[Jonathan Solomon, CEO at BiomX]

During the second quarter, we presented positive safety and efficacy results from the phase I-B, II trial of BX004, including at the 47th European Cystic Fibrosis Conference and the ASM 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 I-B, II 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 U.S. 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 II-B study protocol.

[Jonathan Solomon, CEO at BiomX]

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 II 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.

[Jonathan Solomon, CEO at BiomX]

Both our 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 APT 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.

[Jonathan Solomon, CEO at BiomX]

Now, I will pass the call back to Marina, who will review BiomX's financial results. Marina?

[Marina Wolfson, CFO at BiomX]

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. I will take you through some of the highlights of our second quarter financial results. As of June 30th, 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 2024, 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 equivalent, and short-term deposits are sufficient to fund our operations through the fourth quarter of 2025.

[Marina Wolfson, CFO at BiomX]

Research and development expenses net totaled $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 II-B 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.

[Marina Wolfson, CFO at BiomX]

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 30th, 2024, was $22.6 million, compared to $9.1 million for the same period in 2023.

[Marina Wolfson, CFO at BiomX]

I should add here that we announced today a reverse stock split of one-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 26th, 2024. Now I'll turn the call back over to Jonathan for his closing remarks. Jonathan?

[Jonathan Solomon, CEO at BiomX]

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 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. 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.

[Jonathan Solomon, CEO at BiomX]

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. Thank you for joining us this morning. Operator, would you open the call for questions?

[Operator]

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 star keys. One moment please, while we poll for questions.... The first question comes from the line of Yale Jen with Laidlaw & Company. Please go ahead.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Good morning, and thanks for taking the questions and congrats on all the progress. Maybe I'll just start a little bit with housekeeping questions that you have reported this today, that in terms of the earnings per share, as well as both of the fully diluted and the basic share counts. I just want to get a little bit color in terms of how was that calculated. Was that used the 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.

[Jonathan Solomon, CEO at BiomX]

Sure. So good morning, Yale. Always a pleasure. I'll let Marina handle the tough questions first, so we'll let her take responsibility.

[Marina Wolfson, CFO at BiomX]

Thank you, and good morning. Thank you for the question. So yeah, we're gonna release the full calculations, obviously, and they are included in the note in our 10-Q. 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.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Okay, great. That's helpful. Maybe just one,

[Jonathan Solomon, CEO at BiomX]

Sure.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Things on the housekeeping side of it, which is the R&D expenses of this quarter. Obviously, it's much higher and. But given that's for the combined company, as you was guided at the runway to the end of the next year, so, so should we anticipate R&D expenses over the next few quarters, probably at least for the remaining of this year, will be trending down, and so you'll be able to achieve the goal in terms of the cash runway?

[Jonathan Solomon, CEO at BiomX]

Yale, 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, you know, redundancies, and obviously, we do give guidance and we hold behind it, that the cash runway is until, the end of next year. So accordingly, you know, you'll see kind of the budget trying to, you know, reducing in terms of burn.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Okay, great. And then I just have a question on the pipeline.

[Jonathan Solomon, CEO at BiomX]

Sure.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

In terms of BX004, you indicated that the trial, phase 2-B trial will start in the third quarter of next year. So first, two things here: First of all, is that, are you guys expecting to have FDA meeting later this year, or has this meeting already start, conducted? And secondly, was there any strategical reasons this one seems to be pushed out a little bit in comparison to prior sort of thoughts or estimate from our side? And thanks.

[Jonathan Solomon, CEO at BiomX]

Yeah. Yeah. So Yale, 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.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Okay, great. Maybe the last question here is in terms of 211, you could talk about the phase... I'm sorry, the-

[Jonathan Solomon, CEO at BiomX]

Mm-hmm.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

The top line, first quarter of next year, which is a 13 weeks data in terms of the change of the ulcer size. And after that, let's assume that you have a positive outcome. What might be the next step? Would that waiting for the 52 weeks outcome before you have, you know, contemplate the next step, or you will have something in between, you know, point after the read of the 13 weeks data? And thanks.

[Jonathan Solomon, CEO at BiomX]

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 size 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-

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Sure.

[Jonathan Solomon, CEO at BiomX]

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's, that is the gating item, right? What happens in week 13. I think we can learn more from what happens in the 26 and 52 weeks, right? 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.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Okay, great. That's very helpful, and I'll get back to the queue.

[Jonathan Solomon, CEO at BiomX]

Sure. Great questions. Thank you, Yale.

[Operator]

Thank you. Next question comes from the line of Joseph Pantginis with H.C. Wainwright. Please go ahead.

[Analyst at H.C. Wainwright]

Hi, this is Sara 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.

[Jonathan Solomon, CEO at BiomX]

Thank you, Sara, 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 by spanning over more than two years. We didn't give specific guidance on the status of enrollment. I mean, we've kind of passed the majority of patients and, and, you know, kind of look forward to giving the study on time.

[Marina Wolfson, CFO at BiomX]

Okay, thank you very much.

[Jonathan Solomon, CEO at BiomX]

Thank you.

[Operator]

Thank you. Next question comes from the line of Michael Higgins with Ladenburg Thalmann. Please go ahead.

[Analyst at Ladenburg Thalmann]

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.

[Jonathan Solomon, CEO at BiomX]

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.

[Analyst at Ladenburg Thalmann]

Thank you.

[Jonathan Solomon, CEO at BiomX]

Sure thing.

[Operator]

Thank you. Next question comes from the line of Yale Jen with Laidlaw & Company. Please go ahead.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Thanks for taking this question. I'd just like to get a little bit more color in terms of BX004, when you may be enrolling the first patient for the phase II-B study. Would you announce that, when that happens?

[Jonathan Solomon, CEO at BiomX]

Yeah, traditionally we didn't announce. I think that was... We just kinda, you know, if 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.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Okay, and maybe just a little bit follow-up in terms of 211, again, on 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.

[Jonathan Solomon, CEO at BiomX]

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.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Mm-hmm.

[Jonathan Solomon, CEO at BiomX]

And something around 70% on, 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, then I think that could be, you know, something that, we'll be excited about. These, 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.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Maybe lastly, just in terms, given just the 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 efficacy?

[Jonathan Solomon, CEO at BiomX]

So, I think the 26, and to your point, the 52-week data is mostly about amputations, right?

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Yes.

[Jonathan Solomon, CEO at BiomX]

That's really what, 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. The challenge is that, you know, again, amputations, we 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 compassionate use, I must say, was very exciting, right? Because in 11 out of 12 cases, like, phage treatment has prevented amputations.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Mm-hmm.

[Jonathan Solomon, CEO at BiomX]

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, 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, study is powered for ulcer shrinkage, and everything else will be a, will be a bonus.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

And maybe just tack on that a little bit more, is that do you anticipate or have you spoke with a co-consultant whether amputation will be the kind of endpoint that ultimately for potential approval, or just simply the ulcer reduction, as well as some other metrics will be potentially sufficient for the approval in this indication, which is obviously tough to treat and very few drugs has been simply available for this?

[Jonathan Solomon, CEO at BiomX]

Yeah. So I think in a pivotal study, the most conservative estimate is amputations, right? That's where you need, like-

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Mm-hmm

[Jonathan Solomon, CEO at BiomX]

... you know, 300-patient study and do it properly.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Mm-hmm.

[Jonathan Solomon, CEO at BiomX]

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 amputations, but potentially, you know, I think, we'll work with all the experts to explore some other endpoints as well, of course.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Okay, great. Again, thanks for taking the follow-up questions and, congrats on all the progresses. Maybe last one question here. This probably is for Maria, Marina. In terms of the reverse split, in the press release, you indicate that, from 178 million shares, you know, back to about 17.8 million shares, are these total share outstanding of the basic or that's the fully diluted number?

[Marina Wolfson, CFO at BiomX]

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 Q, because it was only following the Q that we announced it. It will be effective August 26th.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Mm-hmm.

[Marina Wolfson, CFO at BiomX]

The number of shares, the 178 million, is just the outstanding, so that's not the fully diluted.

[Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company]

Okay, great. That's very helpful. And, again, congrats on the, on the progress, and thanks.

[Marina Wolfson, CFO at BiomX]

Thank you.

[Operator]

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.

[Jonathan Solomon, CEO at BiomX]

So I wanted to thank all of you again for joining us this morning, and great questions. We look forward to providing you with additional updates as we make progress. Thank you, and have a good day.

[Operator]

Thank you. This concludes our today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Participants

Executives

• Jonathan Solomon, CEO
• Marina Wolfson, CFO

Analysts

• Yale Jen, Senior Managing Director and Senior Biotech Analyst at Laidlaw & Company
• Analyst at H.C. Wainwright
• Analyst at Ladenburg Thalmann