BiomX Inc.
Q1 2022 Earnings Call Transcript

Published: 11 May 2022

[Operator:]

Good morning. And welcome to BiomX First Quarter 2022 Financial Results and Corporate Update Conference Call. Currently, all participants are in a listen-only mode. There will be question-and-answer session at the end of this call. I'll now like to turn the conference over to Marina Wolfson, Chief Financial Officer of BiomX. Please proceed.

[Marina Wolfson:]

Thank you. And welcome to the BiomX first quarter 2022 financial results and corporate update conference call. The news release became available just after 6

[Jonathan Solomon:]

Thank you, Marina. And good morning everyone. Having recently released our 2021 annual report our first quarter update will have limited new information over what we reported just a few weeks ago on our fourth quarter conference. So I intend to keep the remarks brief on this call and reserve more time for the question-and-answer session. I'd like first to provide an update on BX004, which is being developed for the treatment of chronic respiratory infections in patients with cystic fibrosis or CF. At present, we are working actively to enrol patients in the Phase 1b/2a trial, and we continue to expect initial data from the Phase 1b portion of the trial in the third quarter of 2022. As noted in our prior update, our CF program is being supported through a Therapeutic Development Award from the Cystic Fibrosis Foundation, an organization that has been instrumental in supporting the development of so many life-saving medicines for cystic fibrosis patients. We are also very excited to announce that tomorrow, May 12, BiomX will host a KOL webinar to discuss the treatment landscape for CF patients with chronic lung infections and the potential of BX004, to address patients with chronic Pseudomonas aeruginosa infections. The first part of that event will feature prominent CF clinicians who will review the current treatment modalities at the unmet medical need in treating cystic fibrosis patients with chronic Pseudomonas aeruginosa infections. Following the KOL presentations, BiomX will present its phage therapy BX004, as a potential treatment solution, providing a review of phage candidates, preclinical activity, and an overview of the ongoing clinical development plan. Let me now briefly turn it to BX005 program, which is being developed for the treatment of atopic dermatitis. I'm happy to report that in April, 2022, the FDA cleared the IND application for atopic dermatitis candidate, BX005. BX005 has been designed to restore the skin microbiome composition for AB patients back to its pre flare state by reducing Staphylococcus aureus burden, a bacteria associated with exacerbating inflammation in this particular skin condition. We anticipate initial data from our Phase 1/2 proof-of-concept trial in the fourth quarter of 2022. I'd now like to turn the call over to Marina Wolfson, our Chief Financial Officer to cover our financial results for the first quarter.

[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. As of March 31, 2022 cash balance and short term deposits were $55.7 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 $4.9 million for the three months ended March 31, 2022 compared to $5.7 million for the same period in 2021. The decrease was primarily due to pauses in the development of BX003, the product candidate for the treatment of inflammatory bowel disease and primary sclerosing cholangitis, pauses in the development efforts in the colorectal cancer program, as well as the discontinuing of BX001, the product candidate for the treatment of acne. In addition, the decrease in R&D expenses is due to an increase in grants from the Israeli Innovation Authority, offset by an increase in expenses related to conducting pre-clinical and clinical trials of our CF and AD product candidates, BX004 and BX005, respectively. There was no material change to general and administrative expenses that impacted earnings for the three months ended March 31, 2022, compared to the same period in 2021. Net loss was $8.2 million for the first quarter of 2022, compared to $8.4 million for the same period in 2021. Net cash used in operating activities was $7.4 million for the three months ending March 31, 2022, compared to $6.4 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 through the end of 2023. Additional tranches that will become available to the company under its venture debt facility upon satisfaction of certain specified milestones can further extend the company's cash runway for the first half of 2024. And now I'll turn the call back over to Jonathan for his closing remarks. Jonathan?

[Jonathan Solomon:]

Thank you. Marina. With a good balance sheet and a proof-of-concept data expected within the next 12 months in both our cystic fibrosis and atopic dermatitis program, BiomX is entering an exciting period where we aim to demonstrate positive proof-of-concept data in areas of significant unmet medical need. Either one of these readouts if positive though will represent a watershed moment for our company, clinical validation of our technology platform and the creation of significant value for our shareholders. We thank you for your continuing support, and at this time we'd like to open up the call for questions. Operator?

[Operator:]

[Operator Instructions] Our first question comes from the line of Kristen Kluska with Cantor Fitzgerald. Please proceed with your question.

[Kristen Kluska:]

Hi, good morning and good afternoon, everybody. Thanks for taking my questions. So we've seen the AMR action can deploy more funds recently to the space. So big picture, could you talk about the potential for seeking some non-diluted funds in the future from some of these initiatives, in addition to what you already have in place with, for example, CFF? And when do you think pharma in this space is going to put larger emphasis on AMR and the problems that we're seeing in general?

[Jonathan Solomon:]

Good morning Kristen. Excellent question as always and finally some good weather in New York. So I think – I think it's, what we're seeing is the beginning, right? I think the AMR investment in APT is a great step forward. I think we're in close contact with the AMR and I think what's unique in APT is some of the compassionate use that they've been participating that gives people comfort on phage modality, right? We've seen to your point the BioNTech deal with PhagoMed kind of interest in bacterial vaginosis and endolysin technology. And so I think we're starting to see kind of the cards turn and more and more interest in the field. We're also, if you look at BARDA that has put significant amount in the likes of Vedanta and ContraFect with technologies for bacteremia, again in the microbiome field. So there's definitely more momentum there and I think we plan on leveraging that, but to your point, I think what pharma wants to see is the proof of concept study, right? I think with phage technology there's a lot of anecdotal data that looks very promising, right? In CF, we have 11 patients, now actually more but at least 11 patients that were published that had significant effect. I think will – pharma will really move forward is when they see a POC of a randomly controlled study that is showing significant effect of reducing target bacterial and some clinical effect, and with BiomX we hope to have that in the next 12 months.

[Kristen Kluska:]

Great. Thank you for that. And can you remind us about some of the work you're conducting to potentially go after pediatric patients with phage? And then to an extent most of these compassionate new studies we've seen have primarily been in adolescents and adults. So what if any key differences might you expect with this patient demographic and the approach with phage?

[Jonathan Solomon:]

I think you're right. I mean, for us the pediatric angle would be interesting in indication such as atopic dermatitis, right? Because of the safety profile, but I think it's not what we want to do initially, right. In CF which is also composed of a pediatric population as well as an adult population. Initially we start with adults in atopic; initially will start with mild-to-moderate just based on the work that comes out of UCSD. But I think because of the phage safety profile, pediatric population is definitely the population to pursue after that. And I think that's some of the surveys and KOLs that we talked to express a lot of interest in defining approaches, which are safe and topical in the likes of atopic dermatitis.

[Kristen Kluska:]

Okay, great. Thanks. Looking forward to your webinar tomorrow.

[Jonathan Solomon:]

Thank you.

[Operator:]

[Operator Instructions] Our next question comes from the line of Farhana Sakloth [ph] with Ladenburg Thalmann. Please proceed with your question.

[Unidentified Analyst:]

Hi I'm Farhana on behalf of Michael. We have two questions. So the first is, are you pursuing any partnerships for 004 and on 005 outside of the one that you already have in Japan?

[Jonathan Solomon:]

Hi, Farhana, good morning. I think currently kind of goes back to where Kristen mentioned, I think we – there are some discussions with a few potential pharma partners. I think we're very excited to have Maruho jump in early for a partnership. I do suspect that the more meaningful partnerships will come when we get these POC data, right? So I think that – that's kind of where we see. There's been obviously early investment in the company by J&J and Takeda, but I think now its show-time and we need to show some POC data.

[Unidentified Analyst:]

All right, thanks. And the second question is for 004, like there was a bit of a delay like the enrolment was slow, how's that going now?

[Jonathan Solomon:]

Right. So I think we've – and a month ago we've announced the delay in the CF program. I think we're seeing kind of slowing up in the sites with the omicron surge in the sites. Now things are looking good. So we're cautiously optimistic we're giving, keeping the same guidance kind of working hard and tapping into additional sites and getting good receptions from the – from the patient. So I think there's cautious optimism on the team that we're going to maintain the timeline and provide the data.

[Unidentified Analyst:]

Okay. That's great. And just one last question with 005 when does the enrolment start and are you expecting any kind of, I guess COVID related effects on this trial as well?

[Jonathan Solomon:]

It's a very good question. I think we haven't disclosed any additional detail beyond the fact that the IND was cleared, which is great news for us. Since this is a topical administration, a population which is not very compromised. We don't – you don't expect any, any delays and we're keeping the guidance that we originally gave on data at the end of this year.

[Unidentified Analyst:]

Okay, great. Thank you for taking my questions.

[Jonathan Solomon:]

I bet excellent questions. Thank you.

[Operator:]

And we have reached the end of the question-and-answer session. And I'll now turn the call back over to Jonathan Solomon for close remarks.

[Jonathan Solomon:]

So thank you all again for joining us this morning. We look forward to providing you with future updates on our clinical programs throughout the next year. Have a wonderful day, and please reach out to us if you have any questions. Thank you.

[Operator:]

And this concludes today's conference, and you may disconnect your lives at this time. Thank you for your participation.