Biomx Inc (PHGE) 2022 Q3 法說會逐字稿

Welcome to the BiomX third-quarter 2022 financial results and corporate update conference call. (Operator Instructions) I would now like to turn the call over to Marina Wolfson, Chief Financial Officer of BiomX. Please proceed.

Thank you, and welcome to the BiomX third-quarter 2022 financial results and corporate update conference call. The news release became available just after 6:30 AM Eastern Time today and can be found on our website at biomx.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, design, and expected timing, and interim and final results of our preclinical and clinical trials; the sufficiency of our existing cash, cash equivalents, and short-term deposits; potential receipt of additional funds as milestones are met; the potential benefits of our product candidates; 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, as noted earlier, is on our website.

Joining me on the call this morning is Jonathan Solomon, Chief Executive Officer of BiomX. With that, I will turn the call over to Jonathan.

Thank you, Marina, and good morning, everyone. I intend to keep my remarks brief this morning as, during the third quarter, we remained largely focused on our ongoing Phase 1b/2a trial of BX004 in cystic fibrosis. I'll now provide an update on the program.

As announced in our press release this morning, we made important progress with respect to enrollment during the quarter. Given the challenges enrolling CF patients in the wake of the COVID-19 pandemic, we put in place important mechanisms to improve enrollment. And these measures have produced a recent uptick and considerable acceleration of BX004 enrollment trends that will impact both parts of the trial.

Based on our latest estimates, we now believe that enrollment in part 1 of the study will be completed by year end. Taking into consideration some modest impact from the US holiday season, and the extensive data analysis that follows each patient's dosing schedule, we now expect to report results from part 1 of the trial in the first quarter of 2023 and file the results from part 2 in the third quarter of 2023.

As a reminder, we are developing BX004 as a treatment for CF patients with chronic respiratory infection caused by pseudomonas aeruginosa, or PSA, a main contributor to morbidity and mortality in patients with CF. Part 1 of the trial will evaluate the safety, pharmacokinetics and microbiological clinical activity of BX004 in eight patients in a single ascending dose and multiple dose design. Part 2 of the trial will evaluate the safety and efficacy of BX004 in 24 CF patients randomized to a treatment or placebo cohort in a 2-to-1 ratio.

Last quarter, we highlighted some of the positive outcomes from investigator-sponsored clinical trials that are utilizing phage-based treatment modalities to address difficult-to-treat infections in CF. We are pleased to see a growing data-driven support for the potential benefits of applying phage directed therapies to address these persistent and life-threatening lung infections in CF patients. And we look forward to reporting data from the BX004 program in 2023.

I'd now like to turn the call over to Marina Wolfson, our Chief Financial Officer, to cover our financial results for the third quarter.

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 September 30, 2022, cash balance and short-term deposits were $41.5 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 $3.5 million for the three months ended September 30, 2022, compared to $6.6 million for the same period in 2021. This primarily reflected a decrease in salaries and related expenses and stock-based compensation expenses driven by a reduction in personnel as part of a corporate restructuring we announced in May of this year, as well as pausing the development of BX003, product candidate for the treatment of Inflammatory Bowel Disease and Primary Sclerosing Cholangitis, causing the development of our colorectal cancer product candidate, and the discontinuation of the product candidate for the treatment of acne, BX001. This was partially offset by a decrease in grants from the Israeli Innovation Authority.

General and administrative expenses were $2.6 million for the three months ended September 30, 2022, compared to $2.8 million for the same period in 2021. This primarily reflected a decrease in salaries and related expenses and stock-based compensation expenses related to a reduction in personnel as part of the corporate restructuring.

Net loss was $6.8 million for the third quarter of 2022 compared to $10 million for the same period in 2021. Net cash used in operating activities, $21.9 million for the nine months ended September 30, 2020, compared to $18.5 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 at least for mid-2024. Now I'll turn the call back over to Jonathan for his closing remarks. Jonathan?

Thank you, Marina. BiomX is poised to enter 2023 on solid footing with a strong balance sheet and a focused strategy of advancing BX004 program.

On a personal note, I'd like to close by saying that as the BX004 program has expanded these last several months, many of us at BiomX have had the opportunity and privilege to meet with physicians, advocacy groups and, of course, CF patients themselves, which really drives home the importance of our ongoing research and development efforts.

While great strides continue to be made in extending survival, we know that much more work needs to be done so that people living with CF can live longer and healthier lives. At BiomX our singular focus with the BX004 program is to develop a truly ground-breaking therapy that can achieve this goal. With that Marina and I would now be happy to take your questions. Operator?

(Operator Instructions) Joe Pantginis, H.C. Wainwright.

Hi, Jonathan and Marina, thanks for taking the question and thanks for the quick update. So first, I really want to just focus on the CF program for a moment. First, if you could define the enrollment enhancing mechanisms that you've been discussing. And secondly, as part of that, any -- what the real-world impact had been from the holidays in September on both the scheduling and analyses? Thanks.

Hi, Joe, and good morning. So excellent question. I think we have seen initial enrollment slower than we anticipated. Some of it is definitely the holidays in September and -- but I think mostly as we look into it, it's been on the fact that, as we talk to other peers and companies that have seen slower enrollment rates somehow associated with COVID, with turnover in CROs and some other [third] general trends, I think that we're seeing, right. So I think that's something that's common to the whole industry.

What we've done is obviously work on the interface with the CRO and improve the ways we interact. We've added and increased substantially the number of sites as well as some other mechanisms we put in place internally as well as externally. And I think we've been very, very encouraged by the uptick that we've seen in enrollment, and that's what we're giving the guidance. And you see that although we're seeing the delay in part 1, it doesn't translate to a dramatic delay in part 2, because I think now, we have a good handle on patient enrollment dynamics. So crossing our fingers, I think we're looking at it that way.

Okay. I understand. Thanks for that. And then I guess looking forward to the part 1 data in the first quarter now, for the patients that had already been enrolled and have been on study for x amount of time, is it possible to get any additional information beyond what you might have been looking for, even with regard to any respiratory impacts beyond microbiological? Are you still sticking to the original plan for data release or the types of data?

Yes. So I think we're, sort of, looking at all the standard parameters. I think the part 1 is really short, effectively a few days. So we're not expecting really improvement in FEV1. And again, this is mostly a safety study. So I think that's what we're looking into, right. But we'll measure microbiology as well as FEV1 for the parameters. But definitely the duration is too short for something like that.

I think in part 2, again, still a relatively small study, but here we're looking for more robust signals in terms of microbiology and some anecdotal signals on FEV1. So I think that's -- others have demonstrated some trends there. And I think we'd want to see something there as well.

Got it, thanks for the added color, Jonathan.

You bet.

Mike Higgins, Ladenburg Thalmann.

Thanks, everybody, and thanks, Jonathan, for taking the questions. Just a follow-up, I guess, on 004's enrollment, the pace and so forth. Were there any amendments that were written? Is this just a matter of adding additional sites? And the follow-up to my own question there would be, how many sites did you go from and to [forest]? Thanks.

Thanks, Mike. And good morning. So we have not made any significant amendments. It's definitely those mechanisms, the additional sites. And I do think it's important of craft and perfect interaction with the CROs. We haven't disclosed publicly the number of sites, so we can't share that information, but we have added, and I think you see the uptick. And like everything, it's finding those sites that can give you more patients and a lot depends on personal relationships. So I think it's learning how to work in the post COVID world.

And again, the -- what we've seen recently is this substantial uptick. And I think that's what gives us optimism. And we're seeing -- there's just excitement in the field, right? There's a few other clinical studies in CF, and there's more data trickling from phage in CF. It's just an exciting time for the field and I hope this excitement is also going to help in recruitment, patient awareness, et cetera.

Just to follow up on that, this being a CF Foundation supported clinical trial. I assume those sites are also CF -- CFF trials, but you can just confirm for us. And if not, can you actually go outside of the CF Foundation sites? Thanks.

So we're working hand-in-hand with the foundation. I think they've been a great partner. They are well networked on protocols and thinking how to go about and recruit patients in terms of patient awareness. So they're definitely our partner in this effort. It's been dramatic -- I think without them, the field would have not moved so much. So they're definitely our partner of choice.

Thanks, guys.

Kristen Kluska, Cantor Fitzgerald.

Hello. This is Rick on for Kristen. Thank you for taking our questions. Could you talk about -- switching gears to atopic dermatitis? Could you talk about what specific questions you're asking as you pursue preclinical activities for BX005 and AD? And what specific gating factors are you looking at before getting into a clinical trial in AD?

So, in the atopic derm -- first, good morning. In the atopic derm program, we're basically working with Maruho and their expertise in formulation. I think we're trying to implement takeaways that we had on topical formulation, so working hand in hand with them to think when -- how and when best to launch a study. And again, just bearing in mind the corporate structuring that we had, a lot of the effort is now onto CF, right? And once things are heading in the right direction, we'll be able to reassess how to go about it.

Okay. And maybe just one more thing. The press release, you mentioned wrapping up GMP production for BX005. How should we be thinking about effects on R&D expenses in the near term, keeping this in mind?

So far, it's all been budget. I can let Marina give you more flavor.

Thank you. Hi, good morning. And so yes, the budget and definitely the runway that we announced takes everything into account, including any GMP manufacturing and any programs that we announced.

Okay. Thank you.

We have reached the end of our question-and-answer session. I would now like to turn the floor back over to management for concluding comments.

Thank you again, for joining us this morning, and we look forward to providing you future updates on our clinical programs in the New Year. Again, this is very exciting times in phage therapy in general, and we hope to provide more information in the New Year. Thank you all again.

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