Q2 2023 BiomX Inc Earnings Call

Good morning, and welcome to the biomass second 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 Marine Olson Chief.

Officer, a film X. Please proceed.

Thank you and welcome to the biomass second quarter of 2023 financial results and corporate update conference call.

The news release became available just after 630 am eastern time today and can be found in our website and biomass dotcom.

A replay of this call will be available in 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 his choice statements may be deemed forward looking statements.

For instance, we're using forward looking statements when we discussed on the conference call potential market opportunity to design <unk>.

Is that the timing of interim and final results of our preclinical and clinical trials. The next stages in development.

Fishing sea of our existing cash cash equivalents and short term deposit.

The potential benefits of our product candidates.

The expected benefits from FDA fast track designation.

Potential growth and shareholder value.

In addition, past with vinegar and finical results as long as compassionate and.

Not indicative.

Okay.

Most of our clinical trials.

Except as required by law, we do not undertake to update forward looking statements.

The full safe harbor provisions, 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 Sullivan, Chief Executive Officer of Diana <unk>.

I will turn the call over to Jonathan.

Thank you Marina and good morning, everyone. I am pleased to report that we continued to make significant progress in our bx tableau for program.

We are delighted to update that patient screening for part two of a phase one b to a study has been completed with patient enrollment expected to exceed original estimates, reflecting solid execution by our clinical operations team along with a growing awareness among physicians and patients within the cystic fibrosis community in the potential of this innovative program.

I'm also pleased to announce that would be acceptable for has just received fast track designation from the FDA, which provides further recognition that the big step below a fourth program is addressing one of the most serious and challenging unmet medical needs facing the CF community.

F D a defined addressing a significant unmet medical need as providing a therapy, when nonexistent or providing a therapy, which may be potentially better than available therapies.

The benefit of faster designation include but are not limited to early in frequent communication with the FDA throughout the entire drug development and review process.

In addition faster designation means that would be acceptable for may also be eligible for bowling submission and pardon me to a biologic license application and or new drug application, which shores that questions and issues are resolved question.

After leading to earlier drug approval and access by patients.

As a reminder, be acceptable four is being developed for the treatment of chronic pseudomonas aeruginosa or P. S. A pulmonary infections in patients with cystic fibrosis.

In February 2023 we announced positive results from part one of the trial, which came in better than expected based on the treatment arm displaying notable reductions in PSA procure burden.

Following this announcement in June we got the opportunity to formally present. These data during the late breaking session at the 46 European Cystic fibrosis conference.

Or the E C F C, which is an important international conference that attracts a wide audience of CF thought leaders advocacy groups and patients I can say unequivocally that physicians were excited with a notable reduction bacterial burden displayed in part one of our study and we came away from the E. C. F. C meeting with the impression that chronic do you say pulmonary.

<unk> continue to pose a challenging unmet need for CF patients today.

We therefore believe that would be acceptable for is one of the few and most promising early clinical candidates for treating these infections in CF patients.

With our patient screening efforts now complete we estimate of four to six week delay in our topline results for part two of the study now expected to be announced in November of this year under the part two study design at least 24 CF patients receive picks tableau for twice a day, but over a longer 10 day treatment period compared to part one.

Similar to part one results in part to our intended to provide additional data on safety and reduction in PSA, but Joe Burton along with other exploratory endpoints.

Assuming positive results from the largest study group, we anticipate holding a meeting with the FDA to plan. The next stage, a big stumble a fourth clinical development.

In addition in May 2023 we announced the second closing of a $7 5 million dollar private placement or be pipe with a select group of institutional and individual investors, which provided additional funding to support the bx Diablo four program and other R&D activities. We also added two highly accomplished.

I'm Super Cool executives to our board, who collectively bring to biomass considerable business and legal experience.

In summary, we are very pleased with the continued progress and to be acceptable for program. The feedback we're receiving from physicians patients and other stakeholders within it the CF community has been highly positive and constructive reinforcing our view.

In the therapeutic potential of big fell below four to treat life threatening infection CF patients are facing.

I'd like now to turn the call to Marina to review our financial results for the second quarter of 2023.

Thank you Jonathan as a reminder, the financial information is available in the press release, we issued earlier today and also and 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 June 30th 2023, cash balance and short term deposits with $30.7 million compared to $34.3 million as of December 31st 2022.

Decrease was primarily due to cash used in operating activities, partially offset by proceeds received from the pipe financing.

Research and development expenses net were $3.8 million for the three months ended June 30th 2023 compared to $4.6 million for the same period in 2022.

The decrease was primarily attributed to several factors are.

A decrease in both salaries and stock based compensation expenses, which resulted from a reduction in workforce as part of a corporate restructuring in 2022.

As well as deep prioritizing preclinical and clinical activities related to our atopic dermatitis products candidates be extell a five.

Additionally, we received higher proceeds from collaboration agreements.

However, this decrease in R&D expenses and that was partially offset by expenses related to conducting the clinical trial of our CF product candidate Bx tableau for.

General and administrative expenses were $2.3 million for the three months ended June 30th 2023 compared to $2.4 million for the same period in 2022.

The decrease was primarily due to a reduction in the company of the directors and officers insurance premium.

Net loss was $6 $4 million for the second quarter of 2023 compared to $7.5 million for the same period in 2022.

Net cash used in operating activities was $9.1 million for the six months ended June 30th 2023, compared to $16 $4 million for the same period in 2022.

We estimate the existing cash cash equivalents and short term deposits will be sufficient to fund the company's 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 during.

During the first half of 2023, we made significant progress in advancing our big stumble for program. This momentum has already carried through into the second half of 2023 with the FDA granted <unk> fast track designation and the completion of patient screening in part two of our phase <unk> trial.

One results were clearly better than we had expected and a positive view on big stumble four with further reinforced based on supportive feedback from this year's <unk> meeting.

Tenants at <unk>. He also served as appointment reminder, that thousands of patients are in dire need of new treatment approaches to combat these pervasive and deadly PSA infections based.

Based on our promising results. Thus far we believe picks up before is emerging as a potential viable therapeutic candidate to address the significant unmet medical need in CF.

With that Marina and I are now happy to take any questions operator.

Thank you the floor is now open for questions. If you would like to ask a question. Please press star one on your telephone keypad at this time a confirmation tone will indicate your line is in the question queue. You May Press Star two if you would like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up the handset before pressing the <unk>.

Turkey's again Thats Star one to register questions at this time.

Today's first question is coming from Joe Panton genus of H C. Wainwright. Please go ahead.

Hi, Jonathan a marina thanks for taking the question. So first on double O four for CF on the part two data I guess I want to understand some of the logistics around.

Data and I guess, you know does it have to do with exceeding the enrollment particular end points that you're require additional time for analysis, how should we be looking at that and then also can you give a sense of you know how many patients beyond the expected enrollment you hit.

Joe Good morning are all excellent questions. So as you mentioned basically enrollment.

Because you haven't grown as Gwen.

A lot better than we expected.

It's driven I think by a few factors there is excitement from the part one data.

There's been very good execution from the team. So we literally open centers and got more patients than we anticipated.

And that sort of sped into.

It's not that anything has changed no endpoint has changed everything sort of going according to plan just more patients. There is as you just noted a slight delay it's driven there there are more patients are going through you know kind of the pipeline.

And then some operational issues nothing major.

At this point, we don't want to we're not giving guidance on the exact number of patients crossing our fingers, we want sort of increase the number I think that helps us and you know getting more data and thinking about the next study right. So I think that would be fantastic.

Again.

Did you remember all of the difficulties, we've had with recruiting part one and the delay this is going very very well in part two it's a very different world.

No I appreciate that color and then look up my next question is certainly forward looking and I and I'll preface. It by saying you know the answer could change five minutes from now, but when you look at your upcoming discussions with regulatory authorities for you know looking at studies beyond part two what is your current wish list look like ads.

You know what our clinical program might look like to get to the market as quick as possible pending positive data.

Right. So we're definitely you know, it's a tough and another good question Ryan I think we've got the fast track designation, that's already a step in the right direction.

You know, there's more items that we'd want to pursue such as warfare breakthrough and hopefully accelerated approval right. So I think those are all condition on the data that we see in the discussion with the FDA I think we've seen.

Cases, a fast approval such as Amy Smith with accelerated approval.

And there is cases with smart design, so I think anything that gets us to a product faster.

Brian .

Sure the unmet need, which we're saying is what we're looking for and again, there's always going to be a lot of meat on the bone for the discussion I think the fast drop as sort of a first cig and all of that that the FDA acknowledges the huge unmet need sort of like opening up more channels for discussion.

No I appreciate that and then and then if I could just ask and thank you for indulging me.

The other than the obvious answer of resources. You know are there other potential avenues to be able to sort of reignite our pipeline assets.

You're always welcome to ask more questions right I think I think we all as as you know right. We set up the company to be a platform company and you know we are looking at a bunch of other projects such as the hot topic and others that we're looking at that are now.

We're kind of waiting for more resources. So I do think that if part two looks as good as part one right. Then then there's a second independent reputation.

Randomly controlled study with phage with placebo, that's showing the fact, Brian I think that that would give us and hopefully others.

The confidence that we've got a good handle on this new modality and and I think that could open up multiple panels for discussions right because theres more indications there's more we can do and with phase you can move relatively quickly.

To the clinic with additional programs, but again, it requires definitely additional resources or or collaborators.

Thank you Jonathan.

Pleasure as always.

Thank you once again Thats star one if you would like to register a question. The next question is coming from Michael Higgins of Ladenburg Thalmann. Please go ahead.

Thanks, operator, good morning, guys. Good afternoon, Thanks for taking my questions and congrats from us as well on the fast track designation would have pulled back a bit on the delay of data with additional patients from here in Q3 in November just wanted to clarify for ourselves and everyone.

How much of this data you've been able to review along the way or has there been a review by the CRA all along the way.

Yeah. So I mean, we're completely blinded to the data we have and you know.

We haven't seen anything or can you make any decision I think what we've seen in some of the you know sort of excitement among the sites and what we're seeing is more patients that have been referred by the centers and more patient.

Screening them.

Than we originally anticipated and the decision that we took that the more the merrier. So long as it's only a slight delay because as I mentioned before.

Hey, guys good morning.

But Michael I think as we talked before right. We know this is a new modality and the more data we get the better we're prepared both for discussion with the agency as well as design. The next clinical study.

Yes, it definitely helps to add more patients ahead of the pivotal start.

A question for you on <unk>.

Our next steps.

Do you need to have six months safety data in hand before your end of phase II meeting with the FDA.

Yeah.

It's a great question I think the estimate is that no I think we know you know so far we've we've felt very comfortable with the FDA and sort of held public workshops on faith sort of acknowledging the safety of the modality.

So I think it's sort of a soft follow up.

And the part two.

And hopefully I think we'll have to see.

The information that we had at day 28 should be sufficient to kind of get the discussion going.

And one last one if I could here before I jump back in the queue and maybe come back in with another question later, but we saw additional phase one data CFC, including based on information.

Is there additional information that you plan to share such as is there any data passed the 15 day endpoint any plans if so to share that place.

So we haven't looked at the design I mean, if you recall, a part one which must be a short safety study to kind of paved the way for part two so we don't have longer follow up.

There was a bit more information that were kind of wrapping up.

Hopefully this presented at a conference.

But the heavy lifting and I think most of the information will be at the departure for sure.

And longer follow ups.

I appreciate it thanks guys.

You bet Michael.

Thank you at this time I'd like to turn the floor back over to Mr. Sullivan for closing comments.

And so I have to say thank you again for joining us. This morning, we look forward to providing you with future updates on our clinical programs in the new year have a wonderful day and please reach out to us if you have any questions. Thank you again.

Ladies and gentlemen, thank you for your participation. This concludes today's event you may disconnect your lines or log off the webcast at this time and enjoy the rest of your day.

Okay.

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