BiomX Q1 2023 Earnings Call Transcript

Quartr
Provided by Quartr
May 15, 2023

Key Takeaways

  • Positive Sentiment: Phase 1b/2a Part 1 trial of BX004 showed an average 1.4-log reduction in Pseudomonas burden, exceeding expectations, with Part 2 results anticipated in Q3 2023.
  • Positive Sentiment: Closed a second tranche of a private placement on May 4, raising ~$7.5 million led by OrbiMed and the Cystic Fibrosis Foundation to bolster the balance sheet.
  • Positive Sentiment: Ended Q1 2023 with $30.3 million in cash, equivalents and short-term deposits, providing a cash runway into Q3 2024 under the current operating plan.
  • Positive Sentiment: Reduced R&D and G&A expenses year-over-year through workforce restructuring, cutting net loss to $6.4 million from $8.2 million in Q1 2022.
  • Negative Sentiment: Deprioritized the atopic dermatitis candidate AX005 as part of the corporate restructuring, narrowing the pipeline focus to CF infection therapy.
AI Generated. May Contain Errors.
Earnings Conference Call
BiomX Q1 2023
00:00 / 00:00

There are 5 speakers on the call.

Operator

Good morning, and welcome to the BioMx First Quarter 2023 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 would now like to turn the call over to Marina Wolfson, Chief Financial Officer of BioMx. Please proceed.

Speaker 1

Thank you, welcome to the BioMx Q1 2023 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 biomex.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.

Speaker 1

For instance, we are using forward looking statements when we discuss in the conference call potential market opportunities, the design, aims, 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 and the potential benefits of our product candidates. 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 the 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 Sullivan, Chief Executive Officer of Bionix.

Speaker 1

With that, I will turn the call over to Jonathan.

Speaker 2

Thank you, Marina, and good morning, everyone. BioMx continues to make significant progress with the development of our lead product candidate, AX-four for the treatment of Pseudomonas arginosa or PSA infections in patients with cystic fibrosis or CF. In February 2023, we announced positive results from Part 1 of our ongoing Phase 1b2a trial. These results were better than we had anticipated, particularly with respect to the notable reductions observed in PSA Bacterial burden. Enrollment in Part 2 continues to progress well, and we expect to report results in the Q3 of 2023.

Speaker 2

As a reminder, in Part 2 of the study, we're dosing CF patients with BX004 twice a day and over a longer 10 day treatment period compared to Part 1.

Speaker 3

Part 2 of the

Speaker 2

study is designed to find additional data on safety and reduction in PSA bacteria burden along with other exploratory endpoints. As a reminder, PSA infections are highly pathogenic and represent a leading cause of loss of lung function in people with CF. After a CF patient has been infected with PSA in his or her lungs, it is exceptionally difficult to fully eradicate the infection even with multiple courses of antibiotic treatment. These infections often persist over a period of several years. Unfortunately, treatment with antibiotics begins to wane over time.

Speaker 2

BX004 is a therapy that is designed to directly address the significant and unmet medical need in CF. I'm pleased to note that we had the opportunity to strengthen our balance sheet during this quarter after announcing Part 1 results. On May 4, we closed the 2nd part of a private placement, which altogether raised total gross proceeds of approximately $7,500,000 We would like to thank our existing shareholders, which include OrbiMed and the Cystic Fibrosis Foundation, who led this financing. As a result of this funding, together with our existing cash reserves, we expect that we'll remain well funded through this time period when we expect to announce Part 2 results. In addition to strengthening our balance sheet, we also have the opportunity to expand our Board of Directors.

Speaker 2

Last Friday, we announced the appointment of Jason M. Marks and Michael E. Danbach to the Board of Directors of Biomix. Jason most recently served as Executive VP, Chief Legal Compliance Officer and Corporate Secretary with Amarin Corporation and Michael is Vice President and Treasurer of Biogen. Both of these highly accomplished individuals bring in-depth corporate experience to our Board as seasoned executive leaders within the life science industry.

Speaker 2

As Bioma continues its plans to grow and expand the BX004 clinical program, Jason and Michael will undoubtedly bring invaluable perspective to help guide our decision making on a wide range of financial, regulatory and legal issues. I'd now like to turn the call over to Marina to review our financial results for the Q1 of 2023.

Speaker 1

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 we expect to file later today. I will walk you through some of our brief highlights. As of March 31, 2023, cash balance and short term deposits were $30,300,000 compared to $34,300,000 as of December 31, 2020. The decrease was primarily due to net cash used in operating activities, partially offset by proceeds from the first closing of our pipe financing.

Speaker 1

Research and development expenses net were $4,600,000 for the 3 months ended March 31, 2023, compared to $4,900,000 for the same period in 2022. The decrease was primarily due to reduced salaries and related expenses and stock based compensation expenses resulting from a reduction in workforce as part of the corporate restructuring we announced in May of 2022, as well as deprioritizing preclinical and clinical activities related to our atopic dermatitis product candidate, AX005, partially offset by expenses related to conducting the Phase IbIIa clinical trial of our CF product candidate, CX-four. General and administrative expenses were $1,600,000 for the 3 months ended March 31, 2023, compared to $2,500,000 for the same period in 2022. The decrease was primarily due to reduced salaries and related expenses and stock based compensation expenses due to a reduction in the workforce as part of the corporate restructuring, as well as a decrease in the company's directors and officers insurance premium. Net loss was $6,400,000 for the Q1 of 2023 compared to $8,200,000 for the same period in 2022.

Speaker 1

Net cash used in operating activity was 5 $1,000,000 for the 3 months ended March 31, 2023, compared to $7,400,000 for the same period in 2022. We estimate that existing cash, cash equivalents and short term deposits will be sufficient to fund the company's current operating plan into the Q3 of 2024. And now, I'll turn the call back over to Jonathan for his closing remarks. Jonathan?

Speaker 2

Thank you, Marina. As we enter the second half of twenty twenty three, BioNT is well positioned to deliver on key clinical milestones in our BX004 program. We're obviously encouraged by the results from Part 1 of the trial, which we believe could serve as a positive indicator for the results we hope to achieve in Part 2 of the trial. While great strides have been made over the last few decades to significantly increase life expectancies of CF patients, we also know that chronic and life threatening infections remain the number one cause of morbidity and mortality in this patient population. Our BX004 program is squarely aimed at addressing the significant unmet medical need, and we look forward to expanding this program to help bring forward an important new treatment option for the CF community.

Speaker 2

With that, Marina and I would be happy to take your questions. Operator?

Operator

Thank you. We will now be conducting a question and answer Our first questions come from the line of Joe Pantginis with H. C. Wainwright. Please proceed

Speaker 4

So a couple of questions, Jonathan. First, as we look towards the Part 2 data, it's longer dosing, patients are getting a lot more, phage cocktail as well. So I guess, how can we possibly link the anticipated bacterial load reductions with potential impacts on FEV FEV, sorry, and is it long enough for Part 2 treatment to be able to see an impact?

Speaker 2

Hi, Joe and good morning. So I think you raised a really important question, right? The Part 1 was effectively only 4 days of twice a day dosing, right? And Part 2 is 10 days of twice a day dosing. So Part 2 is definitely longer.

Speaker 2

I think as you know we kind of were not expecting much of a signal in Part 1 and quite pleasantly surprised. I think Part 2 was mostly designed actually to see that material reduction. So I think in terms of our expectations what we want to see is a replication of the significant effect that we've seen in Part 1 and kind of get a robust response of material reduction. In terms of FEV1, it's still a relatively very short period of time and still very few patients, right? So I do think the expectations of

Operator

Okay, everyone. Thank you for standing by. We do have the speaker line back in.

Speaker 2

Hey, Joe. I'm sorry. I don't know if you missed my answer. So let me know if you want to repeat it or you want to go for the second part of your question.

Speaker 4

Actually, can you hear me?

Speaker 2

I can. Sorry about that.

Speaker 4

Okay, great. No, so I lost you when you were talking about the relatively short time of treatment to be able to see a potential impact in FEV or not? Yes.

Speaker 2

So I do think it's longer than Part 1, still rather short. We look at the when you want to see signals in FEV1 patients are dosed for much longer and you look at the antibiotic studies they're reaching months. So I do think you need a much longer period to see the effect. And we do know there is strong correlation between bacterial reduction and clinical improvement, but it usually takes longer. So I think we want to moderate expectations on V1.

Speaker 4

Of course. And that was a key thing I was hoping to ask about and you hit it. So my second part is certainly in the realm of the forward looking statements. So, I don't know if you would like to even take potential broad strokes with us today. So, assuming Part 2 is positive, can you give us a sense of what you might be considering?

Speaker 4

I'm using my words carefully, with regard to next steps, clinical trial designs, regulatory steps, would this be a potential candidate for things like breakthrough designation based on the unmet medical need?

Speaker 2

So it is a forward looking statement, but I think the key I'll try to venture where I can go, right, without being given dirty looks on the accounts. We won't hold anything right now. So I think it's as you said the key is actually the dialogue with regulatory right with the agency as well as I think our strategic partnership with CF Foundation right? I think these are the 2 key parties. We expect, after the data that we'll receive in Part 2 to go hand in hand with the CF Foundation and talk to the agency.

Speaker 2

I do think it is an unmet need, right? Remember these patients that are on this treatment are already on chronic antibiotic treatment. They don't have any options. So I think of course a breakthrough orphan indication, accelerated approval these are all the things that we should consider. And again we look forward to working hand in hand with the agency and the CF Foundation to try to pursue anything that gets us FAFSA to approval.

Speaker 4

No, completely fair. And then, I guess you could call it a logistical question because especially in this day and age, everything still remains focused on resources and you guys have been very cognizant of this. So with that said, is it still just resource based and when you'd like to look to ramp up your pipeline assets such as Atopic or beyond?

Speaker 2

Yes. It's exactly that. I think we're seeing right we're seeing more interest generally in phage right. It was great to see The Economist run a piece on phage and Nature Biotech and seeing data from our peers. So it's kind of picking up and with that we're getting incomings from patients as well as interest in additional indications, right?

Speaker 2

So I think we're also we want to pursue these additional indications because I think there's more interest and get more data coming from compassionate use. Youth. But we need to be disciplined. So hopefully as we make progress we're part 2 and we're better financed I think we'll eagerly kind of expand the pipeline.

Speaker 4

Great. Thank you, Jonathan.

Speaker 2

You bet. Pleasure as always.

Operator

Thank you. Our next question comes from the line of Michael Higgins with Ladenburg Thalmann. Please proceed with your questions.

Speaker 3

Thanks, Sabra. Thanks, guys, for taking the questions. Good afternoon to you, Jonathan. Congrats again on the Part 1 results. As we're looking to Part 2 coming up here in Q3, you talked a bit on the call here about the longer duration of treatment.

Speaker 3

Can you walk us back through as to what we saw exactly in Part 1, the SADMAD? There's still an escalation part there. And how that dose relates to what the patients are getting in Part 2? Is that at that highest dose? Any more detail on that?

Speaker 3

We're getting questions on that for investors would be helpful. Thanks.

Speaker 2

Sure. First, good morning and thanks for joining the call, Mike. So in Part 1, right, the dosing was kind of short. It was a study that was planned for safety. We had 9 patients, 7 were on treatment and 2 were on placebo.

Speaker 2

Basically, all the patients on treatment got the same gene. So they all got on day 1 placebo, on the 2nd day they got a low dose, on the 3rd day they got a high dose and then they got 4 consecutive days of twice a day dosing, right? And that sort of if you go back, we knew from the compassionate cases in the past that it was a roughly 10 day treatment twice a day that led to material reduction. So that's why I think we had low expectations in the Part 1. Kind of said, look, it's only 4 days versus the 10 days, not very many patients.

Speaker 2

So the likelihood of seeing an effect is low. And Part 2, which is 24 patients randomized 2 to 1 dose 10 days twice a day was actually kind of the replication of the capacity use cases, right? So we are expecting to see the robust signal in Part 2. Part 1, what we saw, again, was extremely encouraging and surprising, was an average of 1.4 log reduction. So that's like a 90 5% reduction from baseline.

Speaker 2

We've seen 1 patient with a 3.3 log reduction, that's like 99.96 percent reduction. In the material count, we've seen 2 patients with a 2 log reduction, 99%, 2 patients with log reduction, 90%. Compared to the placebo, that was around 0.3 log, which is within what's accepted. We know the noise of the assay is up to a catalog. So kind of it was a well behaved placebo, quite dramatic effect in the treatment.

Speaker 2

So I think that's where we're very encouraged, right? And that kind of gives us confidence to move forward to Part 2, which is a longer duration and that's where we're expecting replication, hopefully a more robust signal.

Speaker 3

I guess part of the question too, and thanks for all the detail there, is what you are guiding investors to look for from Part 2 where as you said it's BID 10 days and you've had a couple of days of increasing the dose, 4 days BID. So it's the same dose we're testing in 1 and 2 now. But how do you how do we look for the efficacy of Part 2, more of those with the 2, 3 log reduction, less of those with a 1 or a 0.3. We don't want to get out of our skis, but it's hard not to get excited about this when it seems what happens with these 4 days.

Speaker 2

Right. So I think it is we are dosing for a longer period of time. I think we don't understand completely the stage dynamics and with the benchmark saying with antibiotics, when they were effective in the 90s before the old antibiotic resistance, we saw an effect of like a log and a half to 2 log, right? So I think that's sort of what we want to see. I think we'll be content if we can kind of take back the clock to times where the bacteria in these patients were actually responding well to antibiotics.

Speaker 2

So I think if we get a replication hopefully with more patients of what we've seen in Part 1, we're already pretty happy, right? So I think that's where we want to put the threshold hopefully a longer duration can get even a greater effect.

Speaker 3

Fair enough. We'll sit and wait. That was kind of one long question. I apologize, Sultra, put this No, no, but that's

Speaker 2

the big question, right? Yes. You're totally spot on. I think that's a big question. Again, we weren't expecting to see this kind of data in Part 1.

Speaker 2

I think we're all kind of surprised. And I think we want to see that we can replicate the data if we can, right, extremely encouraging because as we said again, these are patients have been chronically antibiotics, right? They're not really responding anymore. And the opportunity to kind of tick back the clock and have such dramatic reductions opens up a lot of optionality and hope for these patients.

Speaker 3

Yes, I'll just add in my color on this is with proper stage identification and approach to the site of infection, which you've got here with this delivery system, it does happen pretty quickly. So I don't know if we're going to see that much of a difference here, but we'll see over time, obviously. But in February, you mentioned possible changes to Part 2. Are there any there? And then at what points during Part 2 are you collecting

Speaker 2

samples? Thanks. Sure. So far so good. I think we're proceeding as planned.

Speaker 2

Patient enrollment is going very well. I think there is broad appreciation in the community of the data that we had in Part 1. And in general, I think it's a potential of phage therapy. So we're keeping our guidance as planned with data in the Q3.

Speaker 3

At what points during the part 2 do you collect for the samples, obviously baseline, but then how often and what points after that?

Speaker 2

So we had it's a 10 day dosing, so we do before and after treatment and then do a week after treatment and 28 days after treatment and then a longer duration after that like a follow-up. We're mandated to have like phone call 6 months later after treatment.

Speaker 3

Okay. So then during the 10 days, there's no additional split on collected, just baseline and day 10, correct?

Speaker 2

Correct. I think we're also let me be correct. I think we're also looking in terms of comparability, we're looking at day 4 as well. Just kind of benchmark the Part 1.

Speaker 3

Okay. Appreciate all the feedback. Thanks guys.

Speaker 2

All the pleasure.

Operator

Thank you. There are no further questions at this time. I would now like to hand the call back over to Jonathan Solomon for any closing remarks.

Speaker 2

Thank you. So I just wanted to thank you all for taking your time this morning and wish you all a good day and good luck to us all. Thank you.

Operator

Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.

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