Q4 2021 Biomx Inc Earnings Call

Thank you for joining us for today's conference. Your conference call will begin shortly.

Thank you for joining us for today's conference the conference call will begin shortly.

Speaker Change: Thank you again for joining us today and your conference will begin shortly. Thank you.

Thank you again for joining us today and your conference will begin shortly thank you.

[music].

Speaker Change: Greetings, welcome to Biomex's fourth quarter in full year 2021 financial results and corporate update conference call. At this time all participants are in listen only mode.

Greetings and welcome to the biomass fourth quarter and full year 2021 financial results and corporate update conference call.

At this time, all participants are in listen only mode.

And the answer session will follow the formal presentation.

Speaker Change: If anyone today should require operator assistance during the conference, please press star zero from your telephone keypad. Please note this conference is being recorded.

Today should require operator assistance during the conference. Please press star zero from your telephone keypad.

Please note this conference is being recorded.

I'll now turn the conference over to Marina Wilson Senior Vice President Finance, Mr. Wilson, you may now begin.

Speaker Change: Thank you and welcome to the Biomics Force Quarter and Full Year 2021 Financial Results and Corporate Update Conference Call. The news release became available to sector 6.30 a.m. Eastern Time today and can be found on our website at biomics.com. A weekly of this call will be available on the investors section of our website.

Thank you and welcome to <unk> fourth quarter, and full year 2021 financial results and corporate update conference call.

The news release became available just after 630 am eastern time today and can be found on our website, our bionics dotcom a.

A replay of this call will be available in the investors section of our website.

Speaker Change: 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 states.

Before we begin I'd like to review the Safe Harbor provision all statements on this call that are not factual historic statements maybe deemed forward looking statements.

Speaker Change: For instance, we're using forward-looking statements when we discuss on the conference call potential market opportunities, the design, aim, 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, the potential receipt of additional cash if milestones are met, the potential benefits of our product candidates, and potential growth in shareholder value.

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

Cassius milestones are met.

Potential benefits of our product candidates and potential growth in shareholder value.

Speaker Change: Accepted as required by law, we do not undertake to update forward-looking statements.

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

Speaker Change: The full safe harbor provision, including risks that could cause actual results to differ from these forward-looking statements, are outlined in today's press release, which is noted earlier, is on our website.

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 in our website.

Speaker Change: Joining me in the call this morning is Jonathan Solomon, Chief Executive Officer of Biomics. With that, I will turn the call over to Jonathan.

Joining me on the call. This morning is Jonathan Solomon Chief Executive Officer of Fei Omics.

With that I will turn the call over to Jonathan.

Thank you Marina and good morning, everyone.

Jonathan Solomon: Let me begin by saying that I believe Biomics is now entering the most exciting period in our company's seven-year history. With proof-and-concept data expected within the next 12 months in both our cystic fibrosis and atopic dermatitis programs, we are poised to generate readouts that could have significant impact on the value of our company.

Let me begin by saying that I believe bionics is now entering the most exciting periods in our company's 70 year history.

With proof of concept data expected within the next 12 months in both our cystic fibrosis and atopic dermatitis programs. We are poised to generate readouts that could have significant impact on the value of our company at.

Jonathan Solomon: At the same time, with the recent equity investments from Maruhu and the Cystic Fibrosis Foundation, we are also well positioned financially with existing cash expected to take us at least until the end of 2023.

At the same time with the recent equity investments on the Blue and cystic fibrosis Foundation. We are also well positioned financially with existing cash I expect it to take us at least until the end of 2023.

Jonathan Solomon: Additional tranches of up to $15 million under our existing loan agreement may further extend our cash runway into mid-2024.

Additional tranches of up to $15 million under our existing loan agreement may further extend our cash runway into mid 2024.

Jonathan Solomon: Let me now provide a brief update on each program, starting with DX004 in cystic ribosome.

Let me now provide a brief update on each program, starting with Dx tableau for consistent crude doses.

Jonathan Solomon: BX004 is our novel phage candidate that is being developed for the treatment of chronic respiratory infection caused by Pseudomonas arginosa, or PRginosa.

The external of four is our novel stage candidate that is being developed for the treatment of chronic respiratory infection caused by pseudomonas, arguing ulcer or PR can also.

Jonathan Solomon: A main contributor to morbidity and mortality in patients with CF. Chronic pyrogynosia infection leads to epithelial surface damage and airway plugging, progressively impairing pulmonary function.

Main contributor to morbidity and mortality in patients with CF chronic PRA satisfaction leads to epithelia, the surface damage and airway plugged it progressive.

Progressively impairing pulmonary function.

Jonathan Solomon: See if patients chronically infected by PRGinosa show a steeper lung function decline, a higher number of pulmonary exacerbations, more hospital admissions and a higher mortality than PRGinosa free patients.

We have patients chronically infected by Paragon also show a steeper lung function decline a higher number of pulmonary exacerbations more hospital admissions and a higher mortality.

Here again, there was some free patients.

Jonathan Solomon: P. erginosa infections usually start in childhood and following prolonged and repeated broad-spectrum antibiotic courses, enhanced resistance to antibiotics develops and leads to the appearance of multidrug-resistant strains, MDR.

Peer getting I'll say infections, Judy start in childhood and falling prolonged and would be the broad spectrum antibiotic courses enhancers as Cynthia eschbach develops and leads to the parents of multi drug resistant.

James M D R.

Jonathan Solomon: Studies have shown that about 80% of CF patients are chronically colonized by pyrogynosal by the age of 20. And the eight-year risk of death was found to be 2.6 times higher in patients with pyrogynosal versus those without it.

Studies have shown that about 80% of CF patients are chronically colonized like paragon outside by the age of 20.

The eight year risk of death was found to be two six times higher in patients with Paragon now so versus dose without it.

Jonathan Solomon: Research has also shown that continued colonization pyrogynous might eventually result in a point where the infection can no longer be controlled, which is further characterized by the expression of biofilm-forming genes within the bacteria itself.

Research is also showing the continued colonization Paragon upside eventually result in a point, where the infection can no longer be control.

Which is further characterized by the expression of biofilm, forming James within the bacteria itself.

Jonathan Solomon: biofilm in his assemblage of surface-associated microbial cells enclosing intercellular polymetric substance, and one of the leading causes for antibiotic resistance.

Biofilm and has established a surface associated microbial cells and closing intra cellular calling metrics substance and one of the leading causes for antibiotic resistance.

Jonathan Solomon: In preclinical studies, BX004 not only demonstrated activity against antibiotic-resistant strains of pyrogynosa, but also showed the ability to penetrate biofilm.

Preclinical studies be X double for not only demonstrated activity against antibiotic resistant strains of Paragon also but also show the ability to penetrate biofilm with.

Jonathan Solomon: We therefore believe BX004 holds significant potential to address this life-learning infection in CF patients.

We therefore believe be XL below four holds significant potential to address this life threatening infection in CF patients.

Jonathan Solomon: the opportunity to address this unmet medical need is also significant. With an estimated 30,000 CF patients in the U.S. and 80,000 worldwide, chronic antibiotic-resistant bacterial infection remains one of the most challenging medical conditions in CF patients.

The opportunity to address this unmet medical need is also significant with an estimated 30000 of CF patients in the U S and 80000 worldwide.

Nick antibiotic resistant bacterial infections remains one of the most challenging medical conditions in CF patients.

Jonathan Solomon: Pyrginosa is the most common and detrimental bacteria in lung infections of CF patients.

<unk> is the most common and detrimental to Kieran lung infections of CF patients.

Jonathan Solomon: And it is estimated that approximately 30 to 50% of these patients suffer from chronic infection due to this bacterium.

And it is estimated that approximately 30% to 50% of these patients suffer from chronic infection due to this bacteria.

Jonathan Solomon: Part one of this trial will evaluate the safety, pharmacokinetics, and microbiological clinical activity of BX004 in eight CF patients in a single ascending dose and multiple dose design.

Part one of this trial will evaluate the safety pharmacokinetics and microbiological clinical activity a big stable of four in HCM patients in a single ascending dose and multiple dose design.

Jonathan Solomon: Part two of the trial will evaluate the safety and efficacy of BX004 in 24 CF patients who will be randomized to receive treatment or placebo cohort in a 2 to 1 ratio.

Part two of the trial will evaluate the safety and efficacy a big stumble for in 'twenty for CF patients will be randomized to receive treatment or placebo cohort in a two to one ratio.

Jonathan Solomon: sites are now open that we are seeing slower enrollment due to the recent COVID wave.

Sites are now open, though we are seeing slow enrollment due to the recent COVID-19 wave.

Jonathan Solomon: So to be conservative, we now expect the readout from part one of the study in third quarter of 2022 and the readout from part two in first quarter of 2023.

So to be conservative we now expect the readout from part one of the study in third quarter of 2022 and the Readouts in part two in first quarter of 2023.

Jonathan Solomon: We are also proud to have the support of the Cystic Fibrosis Foundation for the development of BX004. In January , we announced a Therapeutic Development Award from the Foundation in support of our ongoing Phase I B2A study.

We are also proud to have the support of the cystic fibrosis Foundation for the development of <unk> four in.

In January we announced a therapeutic development award from the foundation in support of our ongoing phase <unk> study.

Jonathan Solomon: The award is structured as an equity investment, and in December , the foundation made its initial investment of $3 million in biomics common stock. Upon completion of patient dosing in part one of the study, biomics would have the right to receive the second tranche of $2 million.

The award is structured as an equity investment and in December The foundation made its initial investment of $3 million in borrowings common stock.

On completion of patient dosing in part one of study bionics would have the right to receive the second tranche of $2 million.

Jonathan Solomon: Now, let me turn to the atopic dermatitis program. We are developing BX005 as a topical phage product candidate targeting Staphylococcus aureus or Staph aureus, a bacterium associated with the development and exacerbation of inflammation in atopic dermatitis.

Now, let me turn to the atopic dermatitis program.

We are developing <unk> five as a topical phage product candidate targeting Staphylococcus aureus or staff force epic chairman associated with the development in exacerbation of inflammation in atopic dermatitis.

Jonathan Solomon: By reducing Staff Wars burden, we believe BX005 has the potential to shift the skin microbiome composition to its baseline state, leading to clinical improvement.

By reducing staff force burden, we believe <unk> five has the potential to shift the skin microbiome composition to its baseline state leading to clinical improvement.

Jonathan Solomon: Atopic dermatitis not only represents a significant unmet need, but the commercial opportunity remains attractive, with the current therapeutic market valued at $5 billion, which is expected to triple over the next few years. Given the size of the market opportunity, we recognize the importance of developing strategic relationships to maximize the value of this program.

Atopic dermatitis, not only represents a significant unmet need but the commercial opportunity remains attractive with the current therapeutic market valued at $5 billion, which is expected to triple over the next few years given the size of the market opportunity, we recognize the importance of developing strategic relationship to maximize the value of this program.

Jonathan Solomon: Last quarter, we announced an agreement with Maruhu for BX005.

Last quarter, we announced an agreement with <unk> for big stable of five.

Jonathan Solomon: As the largest dermatology-focused company in Japan, Maruhu brings exceptional expertise in this therapeutic area, and we are very pleased to have their support for our program.

As the largest dermatology focused company in Japan, Meru, who brings exceptional expertise in this therapeutic area and we are very pleased to have their support for our program.

Jonathan Solomon: Similar to the CF Foundation, Merleau's financial support for BX005 program came in the form of an equity investment in biomics.

Similar to the CF Foundation Lewis financial support for <unk> five program came in the form of an equity investment in bionics.

Jonathan Solomon: Maru purchased $3 million of a common stock at a premium to the market share price. Funding from this investment is intended primarily to support the plan Phase 1-2 study. We anticipate initial data in the fourth quarter of 2022.

My rule purchase $3 million of our common stock at a premium to the market share price funding from this investment is intended primarily to support the planned phase <unk> study, we anticipate initial data in the fourth quarter of 2022.

Jonathan Solomon: With respect to our other programs, our IBD product candidate is expected to enter the clinic next year, and we also expect to build out our preclinical efforts surrounding our colorectal cancer product candidate in 2023 as well.

With respect to our other programs our IBD product candidate is expected to enter the clinic next year and we also expect to build out our preclinical efforts surrounding our colorectal cancer product candidate in 2023 as well.

Speaker Change: I'd now like to turn over the call to Marina Walson, our Senior Vice President in Finance and Operations, to cover our financial results for the fourth quarter and full year results.

I'd now like to turn over the call to Marina Walton, our senior Vice President Finance and operations to cover our financial results for the fourth quarter and full year results.

Marina Wilson: 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 10K, which will be filed later today. I will walk you through some of our brief highlights.

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-K , which will be filed later today.

Walk you through some of our brief highlights.

Marina Wilson: As of December 31, 2021, cash balance and short-term deposits were $63.1 million compared to $57.1 million as of December 31, 2020. The increase was primarily due to net cash provided by financing activities partially offset by net cash used in operating activities.

As of December 31st 2021, cash balance and short term deposits were $63.1 million compared to $57 $1 million as of December 31st 2020. The increase was primarily due to net cash provided by financing activities, partially offset by net cashiers.

And operating activities.

Marina Wilson: Research and Development Expenses met with $22.7 million in 2021 compared to $19.4 million for the prior year. The increase was primarily due to increased expenses related to conducting preclinical and clinical trials of our product candidates and an increase in salaries and related expenses, mainly due to the growth in the number of employees in research and development and clinical activities offset by higher levels of grants from the Israeli Innovation Authority.

Research and development expenses net were $22.7 million in 'twenty, 'twenty, one compared to $19 $4 million.

Prior year.

The increase was primarily due to increased expenses related to conducting preclinical and clinical trials of our product candidates and an increase in salaries and related expenses, mainly due to the growth in the number of employees in research and development and clinical activities offset by higher levels of grants from the Israeli innovation authority.

Marina Wilson: General and administrative expenses were $11.3 million in 2021 compared to $9.3 million for the prior year.

General and administrative expenses were $11 $3 million in 'twenty, 'twenty, one compared to $9 $3 million for the prior year.

Marina Wilson: The increase was primarily due to an increase in expenses associated with operating as a public company, such as directors and officers' insurance, listing fees and investor relations activity, and also due to an increase in stock-based compensation in salaries and related expenses, mainly due to the growth in the number of employees and due to an increase in rent and related operational expenses resulting from moving into our new facility.

The increase was primarily due to an increase in expenses associated with operating as a public company such as directors and officers insurance listing fees and Investor relations activity and also due to an increase in stock based compensation salaries and related expenses, mainly due to the growth in the number of employees engaged.

An increase in rent and related operational expenses, resulting from moving into our new facility.

Marina Wilson: Net loss was $36.2 million for 2021 compared to $38.1 million for the prior year.

Net loss was $36 $2 million for 'twenty, 'twenty, one compared to $31 million for the prior year.

Marina Wilson: net cash used in operating activities was $27.6 million for the year and the December 31, 2021, compared to $24.4 million for the same period in 2020.

Net cash used in operating activities was $27 $6 million for the year ended December 31st 2021 compared to $24.4 million for the same period in 2020.

Marina Wilson: 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 through the first half of 2024.

We estimate that existing cash cash equivalents and short term deposits will be sufficient to fund the company's current operating plan toward the end of 'twenty two 'twenty three.

Additional tranches that would become available to the company and joint venture debt facility upon satisfaction of certain specified milestones and further extend the company's cash runway through the first half of 'twenty 'twenty four.

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

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

Jonathan Solomon: Thank you, Marina. We are obviously very excited about the opportunities that lie ahead for us in our leading product candidate.

Thank you Marina.

We're obviously very excited about the opportunities that lie ahead for us in our leading product candidates.

Jonathan Solomon: cystic fibrosis, and atopic dermatitis. At the same time, we also recognize that the prevailing market conditions within the biotechnology sector have been difficult for companies and investors alike. Despite these ongoing challenges, we are exceptionally well positioned with a strong balance sheet and two proof of concept readouts for our lead clinical programs expected in the next 12 months.

Secret grosses in atopic dermatitis at the same time, we also recognize that the prevailing market conditions within the biotechnology sector have been difficult for companies and investors alike.

Spite these ongoing challenges we are exceptionally well positioned with a strong balance sheet and two proof of concept readouts for our lead clinical programs expected in the next 12 months.

Jonathan Solomon: If either or both of these programs prove successful, we believe there'll be a significant opportunity this year to grow shareholder value.

If either or both of these programs prove successful we believe there will be a significant opportunity this year to grow shareholder value.

Speaker Change: We'd now like to open the call for questions. Operator.

We'd now like to open the call for questions operator.

Thank you.

We'll be conducting a question and answer session if you'd like to ask a question today. Please press star one from your telephone keypad and a confirmation tone will indicate your line is in the question queue.

Speaker Change: If you would like to ask a question today, please press star 1 from your telephone keypad and a confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue.

Can you refresh start to view like to remove your question from the queue.

Speaker Change: If you're just introducing speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

So kristen.

Weaker equipment, it may be necessary to pick up your handset before pressing the star keys.

One moment, please pull for questions. Once again that is star one thank you.

Thank you. Our first question comes from the line of Joe Pesci niche with H C. Wainwright. Please proceed with your question.

Speaker Change: Our first question comes from the line of Joe Pankinas with H.C. Wainwright.

Joe Pinkiness: Hey, everyone. Good morning. Thank you for taking the question. Two questions, Jonathan. First, on the CF program, I guess I wanted to get a little bit of a framework of, I guess, the type of data in the fourth quarter, you know, from part two. I guess I'll ask it this way. What kind of microbiological data do we expect? And then, with regard to efficacy, what would you consider a success, you know, for 24 patients?

Hey, everyone. Good morning, Thanks for taking the question two questions. Jonathan first on the CF program I guess I wanted to get a little bit of a framework of.

I guess the type of data in the fourth quarter from part two I guess I'll ask it this way what kind of microbiology cold data do we expect and then with regard to efficacy.

Would you consider a success you know for 24 patients.

Jonathan Solomon: So, good morning, Joe. It's an excellent question. I think we have two parts in the study, right? So, you kind of focused on part two, which is, I think, the more.

So good morning, Joe.

It's an excellent question I think we have two parts of the study right. So you're kind of focused on part two which is I think the more a significant.

Joe Pinkiness: significant inflection point. Part one, which has a readout in the third quarter, is actually eight patients. And those two work on placebo, six are on treatment. It's a bit of a sad mad study. So we'll kind of give them low dose, high dose, and then a few doses of the high dose.

Significant inflection points part one.

Which has.

A readout in third quarter is is actually eight patients and those two work on placebo six are on treatment is a bit of a sad Mad study.

So what kind of given low dose high dose and then a few doses the high dose right. So it's mostly safety I think we know that phase is relatively safe. So we're not expecting any surprises there I think there is a chance that we might see some.

Speaker Change: Right, so it's mostly safety. I think we know that Fage is relatively safe.

Speaker Change: So we're not expecting any surprises there. I think there is a chance

Speaker Change: that we might see some signs of microbiology efficacy in terms of just reduction of the bacterial count.

Yeah, some signs of microbiology efficacy right in terms of just reduction of bacterial count and again I think in CF. What makes indication exciting is that we know that these patients are actually succumbing to you know to the bacterial infections right. So so basically if you reduce the mcnair significantly you're going to have a clinical effect.

Speaker Change: And again, I think in CF, what makes the indication exciting is that we know that these patients are actually succumbing to, you know, to the bacterial infections, right? So, so basically, if you reduce the bacteria significantly, you're going to have a clinical effect.

Speaker Change: Right. And to your point, the readout in the part two, that's 24 patients, randomized two to one, kind of following the design that Yale did in some of their compassionate youth studies, right? So we're going to treat these patients for 10 days. We're going to measure.

And to your point the rebound in the part two that's 24 patients randomized two to one.

Kind of following the design that Yale data, that's under a compassionate use studies right. So we're going to treat these patients for 10 days, we're going to measure material count before and after treatment. So we want to see a significant effect.

Speaker Change: the bacterial count before and after treatment, if you want to see a significant effect, hopefully greater than the order of magnitude, and that should also translate to some signals on clinical parameters such as FFV1.

Hopefully greater than an order of magnitude.

And that should also translate to some signals on on clinical parameters such as after a few months.

I hope that helps clarify.

Speaker Change: It certainly does and I guess I wanted to ask my next question regarding the atopic dermatitis program and also look a little historically.

It certainly does and I guess I wanted to.

Ask my next question regarding the atopic dermatitis program and also look a little historically.

Speaker Change: When you look at the, I don't know, we'll call it an issue, just the reasons why we feel there might have been issues with the acne program and skin penetration, into the hair follicles and different aspects of the sebaceous gland or what have you, what gives you confidence based on the different skin morphology and underlying pathology of atopic dermatitis that you would not necessarily have that issue.

When you look at the well I don't know we'll call. It an issue. Yes, you know the reasons why we feel there where it might've been issues with the acne program in skin penetration you know into the hair follicles and different aspects of the sebaceous gland or what have you you know what gives you confidence based on the different skin morphology and underlying pathology of a topic during <unk>.

It is that you would not necessarily have that issue.

Speaker Change: It's a great question, right? We've debated length with multiple experts and I think all through the industry with colleagues.

It's a great question right, we've debated at length with multiple experts and I think all through the industry with colleagues.

Speaker Change: I think the main difference is that in acne, the bacteria, as you said, resides inside the hair follicles. So when we're measuring superficially with a skin swab, we're not really seeing what's going on inside the hair follicles. So if you recall, in our phase one, we've actually seen a reduction of the bacterial count, but that's exactly the point. We measured with a swab, and obviously, in a cosmetic study, we're not going to do skin biopsies, punch biopsies to the faces of the skin.

You know I think the main difference is that in acne as you said was either inside the hair follicle. So when we're measuring superficially with a skin swab, we're not really seeing what's going on inside the hair follicle. So if you recall in our phase one we've actually seen a reduction of the bacterial count, but that's exactly the point, we measured with us.

<unk> and honestly you know in a cosmetic study, we're not going to do a skin biopsies punch biopsy the faces of of.

Speaker Change: know, the volunteers. So definitely I think that was the case that we saw the effect happening superficially. It probably did not translate to deeper layers in the phase of the relatively large structure, and we just did not have a clinical effect, right? Penetration is most likely the issue.

The volunteers so definitely I think that was the case that we saw the fed tapping superficially it probably did not translate the deeper layers in the phase of the relatively large structure and we just did not have a clinical effect right penetration is most likely for issue now we're looking into and sort of are implemented implementing more and more takeaways from.

Speaker Change: Now, we're looking into and sort of implementing more and more takeaways.

Speaker Change: from this study on atopic dermatitis. But what gives us comfort is that in the end,

This study on atopic dermatitis, but what gives us comfort is that in the end the bacteria staph aureus is a superficial material right. It's on the scan when you look at the lesion before before theres lesions or have low levels of staff. When you look at the at.

Speaker Change: The bacteria, Staphors is a superficial bacteria, right? It's on the skin. When you look at the lesion before,

Speaker Change: Before there's lesions, there's low levels of staph. When you look at the lesions themselves, there's high levels of staphs. You can see them, you know, skin swabs with very, very high levels. When the lesion kind of goes away, the levels of the cure kind of go down. Interestingly, when we looked at different lesions in the same person,

At the lesions themselves there's high level of stocks you can see then you know skin swab with very very high levels. When the lesion kind of goes away the lovely procure kind of go down.

Interestingly when we looked at different lesions and the same person you see that it's the same strain over the different regions right. So it looks more like an infection.

Speaker Change: you see that it's the same strain over the different lesions, right? So it looks more like an infection and it's not a bacteria that can go.

It's not a victory or it can go deep into the skin right P. C. Acne as one of the most unique material you know only appears in humans only above the shoulder line.

Speaker Change: into the skin, right? C. acne is one of the most unique bacteria, you know, only appears in humans, only above the shoulder line.

Speaker Change: And there's no other animal that has a C acne. There's no good models. So I think in that aspect it's unique and staff, again, is a probably more accessible target and that's why we give a higher likelihood of success in this study.

Theres no other animal that has staph aureus.

C. Acme Theres no. Good models. So I think in that aspect, it's unique and staff again is probably more accessible target and that's why we give a higher likelihood of success in this study.

Speaker Change: That's very, very helpful. Thank you. And if you could just indulge me, if I can just ask a housekeeping question of Marina, since the 10K is not out, would you be able to just give the shares outstanding as of today and the fully diluted count?

That's very very helpful. Thank you and then if you could just indulge me if I can just ask a housekeeping question of Marina.

Since the 10-K is not out would you be able to just give the shares outstanding as of today and the fully diluted count.

Marina Wilson: Sure. Hi. Thank you for your question. So, first of all, the 10-K is going to be filed later today.

Sure.

Thank you for your question so first of all.

The 10-K is going to be filed later today.

<unk>.

Marina Wilson: Approximately 30 million shares outstanding and approximately 47 million fully debited.

Approximately 70 million shares outstanding.

47 million.

Speaker Change: Thank you very much guys. Thank you. Thank you.

Thank you very much guys.

Thank you you bet. Thank you.

Speaker Change: As a reminder, you may press star one to ask a question. We'll pause a moment to assemble a queue. Thank you.

As a reminder, you May press star one to ask a question, we'll pause a moment to assemble the queue. Thank you.

Thank you. Our next question comes from Kay Mackay with Chardan. Please proceed with your question.

Speaker Change: Yeah, thank you. So, Jonathan, for 004, for CF,

Yes. Thank you so so Jonathan for 004 for CF.

Speaker Change: What else is possibly holding up the start of part one?

P J.

What what else is possibly holding up the start of part one.

Speaker Change: Good question. Good morning, Kay. I think what we've seen, not unlike many of the other companies now, is that when you initiate these studies, first, there's issues with the CROs because of COVID, right? So, there has been delays just in terms of like manning, you know, positions at the CRO. So, you know, a lot of the site logistics have been slower. So, I think we've seen that. We've seen that both in a topic as well as in CS, and that's what we decided to kind of...

Good good question. Good morning, Kay I think what we've seen not unlike many of the other companies now.

Is that when you initiate.

These studies first there's issues with the Crows because of Covid right. So there has been delays just in terms of like Manning positions at the zero. So you know a lot of the site logistics had been slower. So I think we've seen that we've seen that both in our topic as well as N C F.

And that's why we decided to kind of you know.

Speaker Change: You know, be more conservative, give in our guidance a bit more time on both of the studies, specifically with

Be more conservative give in our guidance a bit more time on both of the studies specifically with C. S. These patients are a lot more vulnerable to COVID-19 right, they're much more worried and they haven't been in contact.

Speaker Change: These patients are a lot more vulnerable to coven, right? They're much more worried and they haven't been in contact with their physicians for a while through the way. Does it not show up in the clinic? So now, as we've kind of opened up all the sites on time, we see that there's.

With their physicians for a walk through the waves. It did not show up in the clinics and now as we've kind of opened up all the sites on time, we see that there is kind of greater time, they haven't talked to them. They don't know what's the status you know and that kind of fits into we got to make sure. We know all the parameters when we enroll these patients. So we're seeing enrollment are slightly slower.

Speaker Change: kind of greater time, they haven't talked to them, they don't know what's their status, you know, and that kind of fits into, we gotta make sure we know all the parameters when we enroll these patients, so we're seeing enrollment slightly slower.

Speaker Change: So, I'd say it's kind of these two issues, right? Issues which are in the CROs around sort of manpower that I think a lot of other companies have been experiencing, and specifically with CF, there's kind of an additional difficulty because they're so worried about showing up to the clinic given their vulnerability.

So I'd say, it's kind of these two issues right issues, which are in the crows around sort of manpower.

Think a lot of other.

Other companies have been experiencing and specifically with C F.

Additional difficulty because they're so worried about showing up to the clinic given.

Given the vulnerability.

Speaker Change: Okay, and in terms of finding patients with...

Okay and in terms of finding patients with.

Speaker Change: you know, Pseudomonas aeruginosa, is testing or screening for that, is that difficult? It shouldn't, we don't think that it is, but is it difficult, and is there some sort of baseline level of infection that matters, or just the fact that they simply have a chronic infection, you know, just the presence of it is sufficient for them to be part of the.

Pseudomonas aeruginosa is is testing or screening for that is that difficult. It shouldn't we don't think that it is but is it difficult and is there some sort of baseline level of infection that matters or just the fact that they simply have a chronic infection.

Just the presence of it is sufficient for them to be part of the study.

Speaker Change: So I do think, I mean, that's sort of our takeaways. And it's important in phage therapy in general, right? To make sure that they have the bacteria and they have sufficient amounts of the bacteria, right? I think we've learned.

So I do think I mean, that's sort of our takeaways and it's important in phage therapy in general right to make sure that they have of the bacteria and they have sufficient amounts of the bacteria right I think we've learned through our both preclinical and clinical work that the more material Ah patients tend to have the more likely the phase is going to work. So we definitely have a threshold of many.

Speaker Change: through our both preclinical and clinical work, that the more bacteria.

Speaker Change: patients tend to have the more likely the stage is going to work. So we definitely have a threshold.

Speaker Change: of minimum bacteria, you've got to make sure that the regions are producing enough sputin in order to take the sample. So that's definitely some of the parameters.

And bacteria, you've got to make sure that the patients are producing enough disputing in order to take the sample. So that's definitely some of the parameters are.

Speaker Change: that we're putting in and you want to have there. I think on the one hand, I think we're encouraged by, you know, we're getting incoming emails from patients that want to enroll.

But we're putting in and you want to have there I think on the one hand I think we're encouraged by you know we're getting incoming emails from patients that want to enroll into the study and been experiencing and struggling with these infections for years right. So there's definitely a lot of patients out there.

Speaker Change: into the study and been experiencing and struggling with these infections for years, right? So there's definitely a lot of patients out there, but I do think we got to acknowledge the difficulties of COVID.

But I do think we got to acknowledge the difficulties with Covid and sort of you know the system needs to kind of be rebooted. After they kind of disconnected for a few months and you know, let's hope on the crown and the other way it's kind of stayed there.

Speaker Change: And sort of, you know, the system needs to kind of be rebooted after they kind of disconnected for a few months. And, you know, let's hope Omicron and other ways kind of stay connected.

Speaker Change: Okay, and then, you know, I'll ask a similar question about a topic Durham once you get started there, but, you know, in screening for those who have staff areas, you know, again, is there a threshold that you need to see for them to be included?

Okay, and then I'll ask a similar question about atopic derm. Once you get started there, but you know and in screening for those who have staph aureus.

Again is there is there a threshold that you need to see for them to be included.

Speaker Change: Yeah, it's exactly your spot on, right? I think that's the reason we're going to moderate to severe. We want to have high levels of bacteria. We think based on KOLs and some of the studies that have been out there, is that the more bacteria there are out there, the more likely you're going to have an effect.

Yeah, it's exactly you're spot on right I think that's the reason we're going to have moderate to severe you want to have high levels of bacteria. We think based on kols in some studies that have been out there is that the more material. There are out there the more likely you're going to have an effect. So that's exactly the same rationale right we're taking.

Speaker Change: So that's exactly the same rationale, right? We're taking skin swabs, there is a minimum threshold, and only those that A, have a minimum threshold, and B, we can make sure their phage cocktail is relevant to their strains, right? We definitely don't want to be in a situation that we're treating patients that our strains are not relevant. Those are the patients that we enroll. And you know, she.

Skin swab, there is a minimum threshold and only those that have a minimum threshold and b. We can make sure. They're phage cocktail is relevant to their strange right. We definitely don't want to be in the situation that we're treating Christian starter strains are not relevant those are the patients that we enroll and youll sheer here. What we're you know we're also proceeding in our original timeline.

Speaker Change: Here, we're also proceeding in our original timeline in terms of executing the clinical study, and the patients are not worried about COVID, right? That's not the issue. I think we are seeing some of the logistical issues that we talked about at the CROs, though. Okay, all right, thanks for the call. You bet.

In terms of executing the clinical study and the patients are not worried about COVID-19 right. That's not the issue I think we are seeing some of the logistical issues that we've talked about at the crow's, though.

Okay, alright, thanks for the color you.

You bet. Thanks Guy.

As a reminder, you May press star one to ask a question at this time.

Once again.

Press Star one to ask a question.

Thank you.

It appears we have no additional questions at this time I'll turn the floor management for further remarks.

Speaker Change: So, all of you, thank you again for joining us this morning. We look forward to providing you with future updates on our cystic fibrosis and esophageal dermatitis clinical programs throughout the next 12 months. Have a wonderful day and please reach out to us if you have any questions.

So all of you. Thank you again for joining US. This morning, we look forward to providing you with future updates on our cystic fibrosis in atopic dermatitis clinical programs throughout the next 12 months have a wonderful day and please reach out to US if you have any questions.

Speaker Change: This will conclude today's conference. Thank you for your participation.

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