BiomX Inc.
Q1 2021 Earnings Call Transcript

Published: 24 May 2021

[Operator:]

Good morning and welcome to BiomX First Quarter 2021 Financial Results and Corporate Update Conference Call. Currently, all participants are in a listen-only mode. There will be a question-and-answer session at the end of this call. I'd now like to turn the call over to Marina Wolfson, Senior Vice President of Finance and Operations at BiomX. Please proceed.

[Marina Wolfson:]

Thank you and welcome to the BiomX first quarter 2021 financial results and corporate update conference call. The news release became available just after 6

[Jonathan Solomon:]

Thank you, Marina, and good morning to everyone. In the first quarter of 2021, we continue to make substantial progress across our pipeline and we remain committed to achieving our goal of delivering novel natural occurring and synthetically engineered phage therapies that target pathogenic bacteria in the microbiome patients with unmet medical needs. We are excited to be part of the leading efforts in the microbiome space as this is a field which holds a lot of promise. Our approach is compromised the targeting specific strains of pathogenic bacteria in the microbiome that are strongly associated with the diseases and conditions we are investigating. Our rationally designed phage cocktails have the potential to restore the natural, healthy balance of the microbiome to provide patients with safe and effective treatment options. Using our proprietary BOLT platform, we can generate and screen large libraries of phage, prioritizing potential candidates based on cell activity and potency, as well as a number of other parameters that are important for drug development such as safety, stability, and ease of manufacturing. With a focus on executing our priorities, we have successfully and rapidly advanced our phage cocktail candidates in five indications and we expect that potentially clinically meaningful readouts in four different indications within the next 14 months. These important clinical milestones include a Phase 2 readout from our program of BX001 in acne-prone skin or results from the 8-week treatment period are expected in the third quarter followed by results from the 12-week treatment period in the fourth quarter.

[Dr. Sailaja Puttagunta:]

Thank you, Jonathan. BX004 is a newly selected phage cocktail candidate designed to target Pseudomonas aeruginosa, or P. aeruginosa, a bacteria that causes chronic respiratory infections, and is the main contributor to morbidity and mortality in patients with CF. The current treatment options available to CF patients suffering from these chronic infections typically require prolonged and repeated courses of various antibiotics. And over time, their effectiveness diminishes as multi-drug resistant strains appear. BX004 has the potential to be both active against antibiotic resistant strains of P. aeruginosa and to penetrate biofilm, an assemblage of surface-associated microbial cells enclosed in an extracellular polymeric substance and one of the leading causes of antibiotic resistance. Based on our interactions with the FDA, we need to seek guidance, but due to the well established safety profile of phage, we could advance the BX004 directly into a proof-of-concept trial in CF subjects, thereby skipping preclinical toxicity and healthy volunteer studies. With the Company's desire to address as many patients as effectively as possible, we are working closely with the cystic fibrosis therapeutic development network, a network of leading U.S. based CF physicians. As a result, we are updating a Phase 2 proof-of-concept study to a Phase 1b/2a trial comprised of two parts in order to accommodate the recommendations of the cystic fibrosis developing network.

[Jonathan Solomon:]

Thank you, Sailaja. Turning our attention to atopic dermatitis program, we have recently selected a phage cocktail BX005 designed to target Staphylococcus aureus or S. aureus a bacterium associated with the development and exacerbation of inflammation in atopic dermatitis. S. aureus is known to be more abundant over the lesional skin of atopic dermatitis patients compared to the skin of healthy individuals or non-lesional skin of atopic dermatitis patients. The targeted bacteria also increases in abundance and becomes dominant when patients experience flares. We expect results in Phase 2 proof-of-concept clinical study evaluating the safety and efficacy of the BX005 in atopic dermatitis patients in the first half of 2022. Finally, the last program we'll discuss today is our Colorectal Cancer Program in which we're developing synthetically engineered phage designed to target strains of bacteria found in colorectal tumors. Currently, only a small percentage of new colorectal cancer cases respond to immunotherapy, which is believed to be due to the lack of novel tumor antigens and scarcity of immune cells and colorectal tumors. Our approach enables the phage to deliver cancer therapeutic payloads directly to tumors that are hard to reach or impact. We have observed in vitro and in vivo that our phage therapy can target strains of Fusobacterium nucleatum or F. nucleatum a bacterial species that is enriched in colorectal tumors. We are exploring phage-mediated delivery of payload genes such as dose and coatings immune-stimulating proteins, GM-CSF and IL-15, to colorectal tumors while also eradicating the target bacteria.

[Marina Wolfson:]

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. Cash balance and short-term deposits as of March 31, 2021, were $53.6 million compared to $57.1 million as of December 31, 2020. We estimate that existing cash, cash equivalents and short-term deposits will be sufficient to fund the Company's current operating plan until at least mid-2022. Research and development expenses are $5.8 million in the first quarter of '21 compared to $3.5 million for the same period of 2020. The increase is primarily due to stock-based compensation and salaries and related expenses, mainly due to the growth in the number of employees in R&D, and clinical activities and expenses related to conducting preclinical and clinical trials of our product candidates.

[Operator:]

Thank you. At this time, we will be conducting a question-and-answer session. Our first question is from the line of Kristen Kluska with Cantor Fitzgerald. Please proceed with your question.

[Kristen Kluska:]

Hi, everyone. Thanks for taking my questions and congrats on completing enrollment in the acne study. The first question I have here is a big picture one. So, there was a recent study published in Nature, highlighting that the microbiome might have been more diverse in the past from comparing some samples that were up to 2,000 years old, and the authors also highlighted that the present microbiome has more of the antimicrobial resistant strains. So not sure if you're familiar with this particular paper, but I wanted to ask how you believe overtime microbiome composition has changed and how this could correlate with some of the more prevalent and chronic indications including some of what you're evaluating?

[Jonathan Solomon:]

Hi, Kristen, pleasure you're chatting this morning. Very familiar with the paper, I think, very interesting work that follows on a bunch of papers before. And in general, I think you see more and more loss of diversity of the microbiome. And I think, there's a greater need to kind of engineer it precisely and avoid antibiotic resistance. So I think, at BiomX, we feel that this will play an essential role A picking up specific material without blasting the microbiome with more antibiotics, which is just causing more loss of diversity. And second, what we're seeing in some of these pathogens, kind of occupying niches, that, they're dominant in it. So with a phage, we can kind of open up the niche and enable engraftment of more diverse bacteria. So I think it all supports what we're all saying in research, from all across, right. We need greater diversity. We need to avoid using antibiotics as a therapy for these chronic indications.

[Kristen Kluska:]

And then, as you're progressing along the pipeline to the BOLT platform and also resorting to a personalized phage therapy approach for some indications because you remind us of the current phage bank you have on hand and efforts to expand this. And then what work would need to go into finding new phases if necessary to keep it within the rapid timeframes you've laid out?

[Jonathan Solomon:]

Right. So, I think at BiomX, our conclusion has been that instead of investing in a large phage bank, we're actually investing in infrastructure and a large sample collection from whether it's various body of water, sewage, et cetera, whatever you can think of or we don't want to discuss it early in the morning. And you can see the progress, like I think when we came out with BX003, which is a broad cocktail that targets the strain of cocktail, both in IBD and PSC. That was quite an undertaking that we were skeptical, and it took us almost two years to complete. And now with Staph aureus would BX005, within two, three months, we already had a phage cocktail that covered 90% of the strains. So I think you're seeing kind of the economies of scale and the platform mature, as we learn how to handle, move quickly and sort of optimize all of our computational pipelines and robotic infrastructure.

[Kristen Kluska:]

Thanks. And for the atopic dermatitis study, could you walk through why you decided to evaluate a potential eight-week trial?

[Jonathan Solomon:]

Sure. I'll let Sailaja to address that question.

[Dr. Sailaja Puttagunta:]

Thank you, Jonathan, and good morning Kristen. So, the atopic dermatitis because of the mechanism of action of phage where the hypothesis is, if we reduce the bacterial burden of Staphylococcus, that would then lead to a downstream change in the immune response and clinical improvement. So, to accommodate that, we wanted to at least allow an eight-week period to allow us to detect the downstream effects of reducing the bacterial burden of Staphylococcus.

[Operator:]

Our next question comes from the line of Keay Nakae with Chardan Capital Markets. Please proceed with your question.

[Keay Nakae:]

Jonathan, you've given us the timelines to report data from the various studies. I'm wondering with respect to BX003, BX004 and BX005, what are the gating items before you advance these into the actual clinical studies?

[Jonathan Solomon:]

Right, so first, good morning, Keay. It was a pleasure. So I think generally at BiomX, we don't give guidance on initiation of studies. But as you know, the advantage of using this phage approach is that there is no talk study. There's no healthy volunteers study, right? So you can go straight to patient. So say most of these causes are currently in various stages of GMP manufacturing, kind of goes back, I think, to the question Kristen brought before, we quickly put together phage cocktails that look very promising. At that point, we can move straight to manufacturing, get ready and gear up for clinical study. And that's why we think these are maintained in the timeline to be updated on.

[Keay Nakae:]

Okay. And in terms of the CF study design, when we think about the BOLT platform and the ability to use the learnings from initial patients to kind of zero in on an ideal formulation to advance. Are these numbers large enough to allow you to fully optimize the capabilities of both to get to that ideal compound?

[Jonathan Solomon:]

It's an excellent question. I think in CF, we feel I would say more comfortable since there are case studies. The dozen patients that were treated so we have some data that we're basing our thinking and rationale, and again are benefiting from the support the therapeutic development network, the CF Foundation that are all part of this. But to your point, we're going to get a lot of data from these studies, right. We know exactly what strain the patients have. We know the effect, we know how their material composition looks after treatment. So far, we feel that BX004 looks very promising and could be the final product the go-to-market. But we can use a BOLT platform to make these tweaks and we think that there will be enough information, if needed to make these tweaks.

[Keay Nakae:]

Okay. And then just back to the acne study. Congrats on completing the enrollment. From here, what do you need to I guess keep close tabs on to make sure that, when we get to the readout, no other, I guess unforeseen variables enter into the equation?

[Jonathan Solomon:]

Keay, just a clarification question, you mean from the clinical aspect or like business development or?

[Q - Keay Naka:]

Yes, the first, Jonathan.

[Jonathan Solomon:]

From the clinical aspect, okay. I'll let Sailaja to address that.

[Dr. Sailaja Puttagunta:]

Thank you, Jonathan, and good morning Keay. So yes, we're very pleased that we completed enrollment in this study and feel like we are on track to deliver top-line results from the 8-week endpoint in Q3 and then from the 12-week endpoint in Q4 of this year. Really, in terms of unforeseen variables that affect those deliverables, at this point, there we don't see any major obstacles, Keay and we believe we are on track to deliver.

[Operator:]

At this time, our next question is from the line of Joe Pantginis and this with H.C. Wainwright. Please proceed with your question.

[Matt Keller:]

Good morning, everyone. This is Matt Keller on for Joe. Thanks for taking the question. I’ve got one for you. Related to BX003, based on the previous data showing impressively high levels of gut PSC you guys have shown. How confident are you that you're in the right dose range? And relatively, how do you see fitting into possible FDA discussions possibly down the road when it comes to identifying a minimally effective dose?

[Jonathan Solomon:]

Right. Good morning, Matt. I think as we feel rather confidence is at the levels we've seen had abundant levels of phage over bacteria. So again, what we know from the field, multiple studies our internal work is that usually you want to have around 10 phage for every given target bacteria. As a reminder, we achieve levels which were a thousand times higher than that. So there's definitely an abundance of phage, so that gives us a good therapeutic window together with the fact that the phage level stayed high for a few days. So I'd say, we're fairly confident moving into the next study, that we should get high exposure levels and hopefully detect a significant reduction in the bacteria accounts. In general, what we're trying to do in these initial clinical studies is actually to kind of go with a highest dose that is practical because you want to maximize the chance that there's abstaining an effect. Again, if we see a strong effect, we can start titering down the doses. But currently, this is not due to the cost of goods with phage not being prohibitive. It's not a major issue. So I think we can move forward with the current dose, but later in the clinical development we know it was a bit titer down.

[Operator:]

Next question is coming from the line of Michael Higgins with Ladenburg Thalmann. Please proceed with your question.

[Michael Higgins:]

Hi guys, thanks for taking the question and congrats on continued progress. Question for you on the couple of -- a couple I guess on the Phase 1/2 studies. Specifically in CF, what kind of dose range are expecting to be tested in the Phase 1b portion and again quantified by specific numbers at least some sort of a range from bottom to lower the interesting? Thank you.

[Jonathan Solomon:]

Good morning, Michael. I let Sailaja address that question.

[Dr. Sailaja Puttagunta:]

Yes, thank you, Jonathan. So in terms of the dose change, the Phase 1a in CF, that study we're going to start with the single dose. That is in the lower end and in terms of going into specific testing a single dose first, plus safety and then we'll move into single dose that will be two logs higher than the original one. And we, like with all of our other phage there will be candidates, we don't anticipate any safety issues here but -- and so anticipate moving rapidly through the multiple dose phase of the Part 1b.

[Michael Higgins:]

Thank you. And then I just a quick follow-up in terms of atopic dermatitis same question, I suppose. What can you provide for us in terms of what doses may be tested in that study?

[Jonathan Solomon:]

Sailaja, please go for it.

[Dr. Sailaja Puttagunta:]

Okay. Thank you. So, in the atopic dermatitis the first in human study, we're only planning to take the one dose relative to placebo in that study, and move that forward we do believe that, that will be the effective dose. So, there's no dose ranging study planned for atopic dermatitis.

[Michael Higgins:]

I guess this is a follow-up on that. What gives you confidence that you found the right dose to take into the Phase 2?

[Jonathan Solomon:]

So I can jump in. I think here on the atopic derm rash is benefiting from the knowledge that we've seen in acne, right. And what we've seen to-date is that, usually, we want to go with the highest dose that we can. As Sailaja mentioned, there is no dose limiting toxicity to feel confident that that's the way you want to proceed. And again, we can calculate the ratio of phage to bacteria and we feel we're well within a good therapeutic window.

[Michael Higgins:]

That's great and then just one follow-up on atopic dermatitis. How do you think you will work with other therapies in this study? Are they limited from using steroids gels and other atopic dermatitis treatments? Or is it a kind of an all-comers ?

[Jonathan Solomon:]

I think let's Sailaja to address the clinical study and I can talk about just the general thinking of phage approach with other therapies. So Saliaga, please go ahead.

[Dr. Sailaja Puttagunta:]

Great. Thank you. So, for the clinical study, we are not planning any exclusions there and we're pretty much taking all comers. There will be some changes in terms of the washout periods based on existing therapies that patients have been on, but sort of that nothing really major.

[Operator:]

Thank you. At this time, I'll turn the floor over to Jonathan Solomon for closing remarks.

[Jonathan Solomon:]

So everyone, I wanted to thank you for joining us this morning. I want to thank the BiomX team, who worked hard to continue to develop phage therapies across a wide range of conditions as well as shareholders for the support and the patients participating in our clinical trials. It's a very exciting period for BiomX with actually four meaningful clinical readouts in the next 14 months, and we're excited to see the next few months. So everyone please have a wonderful day and please reach out to us if you have any additional questions.

[Operator:]

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