Q1 2023 BiomX Inc Earnings Call

[music].

Good morning, and welcome to the biomass 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.

Now I'd like to turn the call over to Marine Watson Chief Financial Officer of buyer mix. Please proceed.

Thank you and welcome to the Bionics first quarter 'twenty 'twenty screen financial results.

Update conference call.

The news release became available just after 630 am eastern time today and can be found on our website and by all means.

Satcom.

A replay of this call will be available on the investors section about that.

Before we begin I'd like to review the Safe Harbor provision.

All statements on this call and non fossil historic statements may be deemed forward looking statements.

For instance, we're using forward looking statements and we discussed in the conference call potential market opportunity. It is.

And expected timing.

Final results of our preclinical and clinical trials.

Sufficiency of existing cash cash equivalents and short term deposit and the potential benefits of our product candidates.

In addition, paas preclinical and clinical results as well as compassion.

Are not indicative and do not guarantee future success of our clinical trials.

Except as required by law, we do not undertake to a big four Olympic and statements.

The full safe harbor provisions, including risks that could cause actual results to differ from the 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 family.

With that I will turn the call over to Jonathan.

Thank you Marina and good morning, everyone.

<unk> continues to make significant progress with the development of our lead product candidate <unk> four for the treatment of Pseudomonas forgetting El Salvador, PSA infections in patients with cystic fibrosis or CF.

In February 2023, we announced positive results from part one of our ongoing phase <unk> trial.

Results were better than we had anticipated, particularly with respect to the notable reductions observed in PSA picked your burden.

Enrollment in part two continues to progress well and we expect to report results in the third quarter of 2023.

As a reminder, in part two of the study were dosing CF patients with big stumble for twice a day, but over a longer 10 day treatment period compared to pop one.

Part two of the studies is that to find additional data on safety and reduction in PSA bacterial burden along with other exploratory endpoints.

As a reminder, PSA infections of highly pathogenic and represents a leading cause of loss of lung function in people with CF.

After if the patient has been infected with DSA in his or her lungs. It is exceptionally difficult to fully eradicate the infection, even with multiple courses of antibody treatment piece.

<unk> infectious often persist over a period of several years. Unfortunately treat them with antibiotics begins to wane over time.

Big double fourth the therapies designed to directly address the significant unmet medical need and see us.

I'm pleased to note that we adopt and to strengthen our balance sheet. During this quarter. After announcing part one results on may 4th we closed the second parts of a private placement, which altogether raised total gross proceeds of approximately $7 5 billion we.

We would like to thank our existing shareholders, which include <unk> and it's the secret grocery Foundation, who lead this financing.

As a result of this funding together with our existing cash reserves, we expect it will remain well funded through this time period, when we expect to announce park to results.

In addition to strengthening our balance sheet. We also have the opportunity to expand our board of directors last Friday, we announced the appointment of Jason and Mark and Michael E book to the board of Directors, our bionics Jason.

Jason Most recently served as executive VP, Chief legal and compliance officer, and corporate Secretary with Amarin Corporation, and Michael <unk>, Vice President and Treasurer of Biogen. Both of these highly accomplished individuals bring in depth corporate experience to our boards and fees as an executive leaders within the life science industry.

Continues its plans to grow and expand because tableau for clinical program, Jason and Michael will undoubtedly bring valuable 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 first quarter of 2023.

Thank you Jonathan.

A reminder, the financial information is available in the press release issued.

Earlier today and also in more detail in Form 10-Q, which we expect to file later today.

Well walk you through some of our police fireeye.

As of March 31st two.

2020, free cash balance and short term deposits with $32 million compared to $34 $3 million as of December 31st 2020.

The decrease was primarily due to net cash used in operating activities, partially offset by Turkey, and the first closing of a pipe financing.

Research and development expenses were four.

$4.6 million for the three months ended March 31st 2023, compared to $4 $9 million for the same period in 'twenty two.

The decrease was primarily due to reduced salaries and related expenses and stock based compensation expenses, resulting from a reduction in workforce part of the corporate restructuring we announced in May of 2022 as.

As well as be prioritizing preclinical and clinical activity, maybe Troy atopic dermatitis product candidate <unk>.

Below five.

Partially offset by expenses related to conducting the phase one b to a clinical trial of our CFO .

And to the extent below four.

General and administrative expenses were $1 $6 million. The three months ended March 31st 2020 food.

That's a $2.5 million in St. Peter I didn't hear anything too.

The decrease was primarily due to reduced salaries and related expenses and stock based compensation expenses due to a reduction of works like it's probably going to Quebec restructuring.

The decrease in the company's directors and officers insurance premiums.

That's about one four.

$4 million for the first quarter and 23 compared to $8 2 million gallons for the same period in 'twenty two.

Net cash used in operating activities was $5 million for the three months ended March 31st lien 23, compared to seven $4 million for the same period in 'twenty 'twenty.

We estimate that existing cash cash equivalents and short term deposits.

Sufficient to fund the company's current operating plan into the third quarter of 'twenty 'twenty four.

And now I'll turn the call back over to Jonathan for his closing remarks Jonathan.

Thank you Marina as we enter the second half of 2023 by Alex is well positioned to deliver on key clinical milestones.

<unk> four program, we obviously encouraged by the results from part one of the trial, which we believe could serve as a positive indicator for the results we hope to achieve in part two 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 the chronic and life threatening infections remained the number one cause of morbidity and mortality in this patient population.

Our <unk> four program.

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.

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

Operator.

Thank you we will now be conducting a question and answer session.

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.

Press Star two to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys on moment. Please while we poll for your questions.

Yeah.

Our first questions come from the line of Joe <unk> with H C. Wainwright. Please proceed with your questions.

Hey, everybody. Thanks for taking the questions. Good morning. Good afternoon. So a couple of questions. Jonathan first as we look towards the part two 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 bacteria.

Load reductions with potential impacts on S. D V. F E V. Sorry, and is it long enough for part two treatment to be able to see an impact.

Hi, Joe and good morning.

So I think you're raising a really important question right. The part one was effectively only four days of twice a day dosing right and part two is 10 days of twice a day dosing. So part two is definitely longer.

As you know, we kind of we're not expecting much of a single one part one and what quite pleasantly surprised I think part two was mostly designed actually to see that but share reduction. So I think in terms of our expectations, what we want to see.

Is it replication of the significant effect that we've seen in part one.

And kind of get a robust response of material reduction in terms of FTE won it.

They all are relatively very short period of time and still very few patients right. So I do think the expectations of.

Ladies and gentlemen, please standby for technical difficulties. Please standby.

Yeah.

Yes.

Okay.

Okay, everyone. Thank you for Santa Barbara do you have the speaker line back in.

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

Actually can you can you hear me.

Okay. Okay, great. So I lost you when you were talking about the relatively short time of treatment to be able to see potential impact in F&B or not.

Yeah. So I do think it's longer than part one still rather short we look at that when you wont see a signals an SUV one patients or dose much longer and you look at the antibiotic studies urging months.

So I do think you need a much longer period to see the effect that we do know theres strong correlation.

Between bacterial reduction and clinical improvement they usually takes longer.

I think we want to do.

We had expectations on <unk>.

Of course, and that was a key thing I was hoping to ask about it.

So 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 two is positive can you give us a sense of what you might be considering I'm using my words carefully with regard to next steps you know clinical trial designs regulatory.

Steps would this be a potential candidate for things like breakthrough designation you know based on the unmet medical need.

So you know it is it is a forward looking statement, but I think the key I'll tried adventure, where where it can go right without being.

Given dirty looks on the account we won't.

Right now.

And so I think it's 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 two key parties we expect.

After the data that we'll receive in part two to go hand in hand, with the CF Foundation I talk to the agency I do think it is an unmet need right. Remember these patients are on the stream are already on chronic antibody treatment. They don't have any auctions. So I think of course with breakthrough orphan indication cellular approval at these are all.

All of 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 a fast to approval now completely fair and then I guess I guess you could call. It a logistical question because especially in this day and age and Everything's still remains focused on resources and you guys have been very cognizant of this so with that said is it still just resource base than when you'd might to look to.

Ramp up your pipeline assets, such as a topic or beyond.

Yeah, 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 economists ran out 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 incoming phone patients as well as interest in additional indications right.

I think we're also you know we want to pursue these additional indications because I think there is more.

Interest and and you know again more data coming from compassionate use but you know we need to be disciplined so hopefully as we make wireless work part two and where better finance I think we are eagerly kind of expand the pipeline great.

Great. Thank you Jonathan.

You bet pleasure as always.

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

Hey, Thanks, guys for taking the questions. Good afternoon. Thank you Jonathan and congrats again on the part one results.

We're looking to our two coming up here in Q3.

You talked a bit on the call here about the longer duration of treatment can you walk us back through as to what we saw exactly in part one sad Mad.

We're still in the escalation part there.

And how that dose relates to what the patients are getting a part too is that that highest dose any more detail on that.

We're getting questions on that short answer would be would be helpful. Thanks.

Sure first good morning, and thank you for joining call Mike.

So in part one right.

The dosing was was kind of short it was a study that was plant safety. We had nine patients seven were on treatment and two were on placebo basically all the patients on treatment got the same machine. So they all gone in day, one placebo on the second day that got a low dose on the Thursday, the got a high dose.

And then they got four consecutive days of twice a day dosing and that sort of if you go back we knew from the compassionate cases in the past that.

That he was at roughly 10 day treatment twice a day that led to material reductions. So that's why I think we had low expectations in the part one kind of said look it's only four days versus the 10 days not very many patients. So the likelihood of seeing an effect is low and part two which is 24 patients random.

Two to one dose 10 days twice a day was actually kind of a replication of the compassionate use cases, right, we're expecting to see the robust signal in part two.

One what we saw again was extremely encouraging and surprising was an average of 1.4 log reduction so thats like a 95% reduction from baseline we've seen one patient with a three three log reduction back with 90, 996%.

<unk> seen two patients with two log reduction 99% to patients with log reduction 90% compared to the placebo that was around 0.3 logs, which is within what's accepted we now have the noise of the assays up till a catheter lock so kind of it was a well behaved placebo quite dramatic effects.

<unk> and <unk> and the treatment. So I think that's why we're very encouraged.

And courage.

Right and that kind of gives us confidence to move forward to part two which is a longer.

Duration and natural we're expecting a replication of hopefully a more busing.

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 two where as you said, it's 10 days and he said.

A couple of days of increasing the dose for four days.

Same dose, we're testing and wanted to know but.

How do you how do we look for the <unk>.

You can see part two more of those with the.

Two three log reduction less of those within a one or a 0.3.

We don't want to get out over our skis, but it's hard not to get excited about this we've seen what happens with <unk>.

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 benchmark Zhang with antibiotics. When they were effective and then consider the whole of the antibiotic resistance, we thought back log and a half to two lakh crore.

Right. So I think that's that's that's sort of what we want to see I think will be content. If you can kind of take back the clock to times, where.

The bacteria and these patients were actually responding well to antibiotics.

I think if we get a replication hopefully with more patients of what we've seen in part one were already pre pretty happy right. So I think thats, what we want to put the threshold hopefully longer duration can get even a greater effect.

Fair enough, we'll sit and wait so that was kind of one long question apologize ultra quicker.

The big question right.

Yes.

<unk> I think that's a big question again, we werent expecting to see this kind of data in part one I think we're all kind of surprise.

And I think we want to see that we can replicate the data we can write extremely encouraging because as we said again. These are patients that have been chronically antibiotics right theyre, 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.

Yes, I'll just add in my my color and this is with proper stage identification and.

Approach to the site of infection, which you've got here with this this delivery system. It does happen pretty quickly. So I don't know if were going to see.

That much of a difference here, but what we'll see over time, obviously, but.

In February you mentioned possible changes to part two are there any are there and then at what point during part two are you collecting samples.

Okay.

Sure. So so far so good I think we're proceeding as plan a patient enrollment is going very well.

There is broad appreciation of the community.

The data that we had in part one and in general I think of the potential of phage therapy. So.

So we're keeping our guidance to as planned with data.

Third quarter.

At what points during the week.

Part two do you collect the samples obviously baseline, but then how often and what points after that.

So we had its a 10 day dosing so we do before and after treatment and then.

A week after treatment.

David after treatment and then a longer.

Longer duration after that like a follow up where mandates Hello phone call six months later after treatment.

Okay. So then during the 10 days, there's not additional split them collected baseline data correct.

Correct I think we're also.

B correctly I think we're also looking at in terms of comparability were looking for as well just kind of benchmark the barbell.

Okay I appreciate all the feedback thanks guys.

Okay.

Okay.

Okay.

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

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.

Thank you. This does conclude today's teleconference. We appreciate your participation you may disconnect your lines at this time.

Joy the rest of your day.