Q4 2020 Biomx Inc Earnings Call
[music].
Greetings welcome to biomass fourth quarter and full year 2020 financial results call.
At this time all participants are in a listen only mode.
<unk> and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero from your telephone keypad.
Please note on this conference is being recorded.
I'll now turn the conference over to Marina Wolfson SVP Finance Mr. Wilson, you may begin.
Good morning, everyone and welcome to day Bionics fourth quarter and full year 2020 financial results and update conference call.
The news release became available just after 630 am eastern time today and can be found on our website at <unk> Dot com.
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 for it.
Instance, we're using forward looking statements when we discussed on the conference call.
Market opportunities the capabilities of the bolt platform for design and expected timing and interim and final results of our preclinical and clinical trials and studies the sufficiency of our existing cash cash equivalents and short term deposits on our pipeline and momentum and the potential of our <unk>.
IDEXX candidates, 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 outlined in today's press release, which as noted earlier is on our website channel.
Me on this call. This morning on Jonathan Solomon, Our Chief Executive Officer, Zafar on our Chief business Officer, and Dr. Savage up for <unk>, Our Chief Medical officer with that I will turn the call over to Jonathan.
Thank you Mariano good morning, everyone and thank you all for joining us today.
2020 was a year of tremendous progress for bottlenecks marked by the addition of two new programs for our pipeline on top.
For dermatitis, and cystic fibrosis as well as the announcement of positive phase one data for our lead program and acne prone skin.
Our progress in the clinic continued into 2021 as just last month, we announced positive phase one pharmacokinetic data for inflammatory bowel disease also known as IBD.
We are proud of our results a day, especially given the challenges of COVID-19, as this could not have been achieved without the dedication and persistence of biologics research and development team.
Our steady clinical progress has positioned us for even more busy and productive 15 months ahead.
To put our progress on perspective fueled by the advance in agile capabilities of our bowl platform, we expect to have for meaningful clinical data readouts within the next 15 months.
This was a preclinical readouts that will further support our pipeline advancing for years to come.
Specifically in 2021, we are expecting preclinical in vivo data in colorectal cancer in the second and third quarters.
We then expect phase II data in acne prone skin in the third and fourth quarters and a phase II readout in cystic fibrosis in the fourth quarter.
These clinical results are expected to be followed by a phase II readout in atopic dermatitis in the first half of 2022.
In a phase <unk> readout in IBD and PUC by mid 2022.
Over the past several years, we have seen a lot of momentum in the microbiome space with many global companies researching potential effects of modeling the microbiome on a wide range of diseases. The encouraging clinical results that biomass and other companies have generated to date.
Signal that restoring balance on the microbiome by either eliminating pathogenic bacteria.
Adding beneficial bacteria could have a substantial impact on various clinical disease, we believe that our unique approach, which utilizes proprietary combination or cocktails of naturally occurring or synthetically engineered phage to create therapies that target and kill specific pathogenic bacteria without disrupting good bacteria.
Has immense potential to provide patients with a safe and effective treatments.
The breadth of our pipeline as well as our rapid progress has been made possible due to our bolt platform, which leverages our experience and technical achievements over the last five years, the bolt platform along with understood safety of phage enables us to develop manufacture and formulate novel phage therapy candidate.
That target a particular pathogenic bacteria at an unprecedented speed.
The platform employs cutting edge capabilities across disciplines, including computational biology, microbiology robotics synthetic engineering unique assay development manufacturing and formulation.
Having all these capabilities in house has enabled us to build a diverse portfolio spanning various indications.
Yeah.
At this time I would like to review each program in more detail beginning with <unk>, one for acne prone skin.
As you May recall <unk> is a topical gel comprise of a cocktail of naturally occurring phage debt targets could you picture in acne for C. Acne bacteria implicated in the pathophysiology of acne Vulgaris.
About a year ago, we reported positive phase one results, which demonstrated a statistically significant reduction of <unk> levels in the high dose cohort of <unk> compared to placebo.
We also found from additional pre specified analysis that the subjects, who had an earlier and more pronounced reduction in CRP levels.
After a big double O on treatment when compared to placebo, where those with a higher bacterial burden at baseline and those with characteristics associated with a higher load a baseline for.
Features that may be consistent with the mechanism of action of our phage cocktail.
Encouraged by our phase one results, which help enrich our study population we initiated a phase III cosmetic clinical study earlier. This month. This trial is valuing subjects for a longer duration has more subject compared to our phase one trial and aims to demonstrate a clinically meaningful effect.
<unk> on day, eight and 12 week treatment periods are expected in the third and fourth quarters of 2021, respectively.
The next program I would like to discuss is the IBD in PSC, which addresses a large market opportunity where based on scientific literature. The microbiome has suggested to play a meaningful role.
As you May recall last November we consolidated our IBD and PC programs into one phage therapy big stay below three.
For both indications with a single broad host range phage cocktail that works by targeting clubs you on pneumonia streams, which are harbored in the gut of both patient populations.
In February of this year, we announced positive phase one data from pharmacokinetics first in human study of <unk> two.
This was the first ever clinical study detailing pharmacokinetics of an orally delivered phage under our U S food and drug administration RMB protocol. The study met its objective of delivering high concentration of viable stage two the Gi track through the delivery of approximately 10% of thin phage forming units.
Which approximately a thousand times more viable stage compared to the bacterial burden of Hep C on ammonia as measure than the stool of IBD patients incur.
Encouraged by these positive results, we plan to initiate a phase <unk> study for <unk> three with results expected by mid 2022.
Yeah.
I will now turn to our recently added programs, which we initiated in November 2020 today, we announced two phage therapy candidates Bx tableau for an <unk> below five for cystic fibrosis, and atopic dermatitis, respectively derived from a bolt platform.
Utilizing cutting edge methodologies and capabilities of our platform, we were able to select and test. These candidates in preclinical settings and an unprecedented speed.
A reminder, the bolt platform allows for the completion of our clinical proof of concept study in patients, meaning phase II results are possible generally within approximately 12 to 18 months from project initiation.
I will discuss our cystic fibrosis for CF program first as we expect to announce results from a phase II proof of concept study by the end of this year evaluating the safety and efficacy of <unk> for in CF patients.
According to the cystic fibrosis Foundation 2019 registry out of the 33000 and CF patients in the U S. Approximately 9000 patients suffer from chronic respiratory infections caused by pursued them on the <unk> for P argument.
Chairman that contributes to morbidity and mortality in patients with this condition. The current treatment options typically require prolonged and repeated courses of various antibiotics and overtime their effectiveness diminishes as multi drug resistant strains appear.
<unk> is uniquely positioned to potentially provide a groundbreaking effective and safe therapy that would improve lung function quality of life as loves life expectancies for these patients who are in dire need on.
Our newly selected Costco candidate <unk> for is designed to act in two ways as demonstrated by preclinical in vitro studies.
Number one kill antibody strength of PR and number two.
[noise] penetrate biofilm, an assemblage of surface associated microbial cells and closed on an extra seller polymeric substance, which contributes the clogging of the lungs and is one of the leading causes to antibiotic resistance.
Based on these earlier data, we look forward to announcing results from the phase II study in the fourth quarter of 2021.
In November 2020, we also added atopic dermatitis to our pipeline and today announced the selection of topical phage candidate Bx double O five targeting Staphylococcus aureus or S. Aureus, epicure that contributes to the development and exacerbation of inflammation in atopic dermatitis.
Aureus becomes the dominant bacteria when patients experience flares and its abundance has been linked to disease severity with a recognized strong safety profile for <unk>.
<unk> has the potential to provide significant treatment benefits to patients, especially children as the current standard of care carries potential safety risks and in some cases negative side effects.
In preclinical in vitro studies.
<unk> five was shown to be active on over 90% of a panel of S or strange, including antibiotic resistant strains isolate from the skin of subjects in the U S and Europe.
We are on track to initiate our phase II proof of concept clinical study in the second half of this year and expect results in the first half of 2020 share.
Finally, turning to colorectal cancer.
We're exploring phage media delivery of therapeutic payloads for the treatment of colorectal cancer, such as immune stimulating protein GM CSF and IL 15, we have observed in vitro and in vivo that are phage therapy effectively target strains of foods at a share nuclear on them or F. Nucleonic Victor your found to be present in colorectal tumors.
In December we presented preclinical results that confirm the presence of nuclear on them in 80% of tumor samples of patients with colorectal cancer.
We have already successfully engineered and IL 15 gene payload into F. Nuclear on stage and now look forward to sharing preclinical results from animal models evaluate the use of phage therapy in combination with checkpoint inhibitors expected in the second and third quarters of 2021.
As just described biomass is committed to becoming a leader in destroying health to the microbiome by deploying faith to remove potentially harmful bacteria and provide safe and effective therapies to patients who need it most.
2020 was an incredible year of growth Mark not only by positive clinical results in the acne prone skin and our pipeline extension, but also evidenced by our collaboration with Burger Ingelheim to utilize buyer mix ex market platform, a microbiome based platform aimed at identifying biomarkers associated with patients.
Santa types in IBD.
Looking ahead, we are positioned for steady and continued pipeline advancement. This year as we progressed toward mid stage development with for meaningful clinical Readouts expected in the next 15 months.
We look forward to keeping you informed on our progress.
I'd now like to turn the call over to Marina Woolfson, Our senior Vice President of finance and operation to cover our financial results for the fourth quarter and full year 2020.
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.
We also included in the press release financial information about our results in the fourth quarter of 2020, I will walk you through some of our brief highlights.
Cash balance on short term deposits as of December 31st 2020, or 57 $1 million compared to 82 point from in Dallas as of December 31st 2019.
Research and development expenses were $21 million in 2020 compared to $13 $5 million in 2019.
The increase was primarily due to the growth in number of employees, resulting stock based compensation and salaries and related expenses and get your manufacturing of candidate products for clinical trials in <unk>.
Current skin IBD and PSC.
General and administrative expenses were $9 $3 million in 2020 compared to $8 $7 million in 2019 net.
The increase was primarily due to expenses associated with operating as a public company such as directors and emphasis on insurance.
Having legal and accounting expenses.
Net loss was $31 million in 2020 compared to $26 million in 2019.
Net cash used in operating activities with China for a point for a million dollars for 2020 compared to $17 $6 million in 2019.
We estimate that existing cash cash equivalents and short term deposits will be for.
To fund the company's current operating plan for a mid 2022.
I would now like to open the call up for questions operator.
Thank you well now be conducting a question and answer session.
You'd like to ask a question. Please press star one from your telephone keypad and a confirmation tone will indicate your line is in the question queue do you mean for us to start to feel I assume just for your question.
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One moment. Please so we poll for questions.
Thank you.
My first question is coming from the line of Kristen <unk> with Cantor Fitzgerald. Please proceed with your question.
Hi, everyone. Thanks, so much for taking my question and hope all is well and apologies I actually hopped on the call a few minutes late so sorry, if I'm asking something you already addressed but wanted to ask about the bolt platform.
For <unk> five and if you could perhaps talk about the number of cocktails that were evaluated for these programs and why specifically you felt these were the most promising to take forward.
Thanks, Kristen Oh, it's a pleasure and.
And thank you for the great question.
So I think the bolt platform has delivered.
In these two cocktails and hope for an old five I mean, we obviously screen hundreds of candidates and we today announced the two cocktails.
<unk> made tremendous progress in terms of their host range and parameters.
For clinical outcome. So I think we feel very confident after one hundreds of phage that were tested but we have a cocktail.
That has the attributes of host range biofilm stability into route of delivery and you know not carrying toxic changed on others.
Great. Thank you and then for the cystic fibrosis study what specific data on might we hear from this study to read out and what are you going to be the main factors you look at to decide whether to move forward with later stage trials or perhaps other faiths applications that.
Similar.
Sure I'll, let siloed to actually address the clinical question.
Great. Thank you Jonathan.
On the cystic fibrosis study are we at.
The primary endpoint is going to be safety and Tolerability.
A nebulizer administration opiate zone four in patients with cystic fibrosis, who have chronic.
And as a pulmonary infections, but key exploratory end point for building to be looking at the ability of this stage product to decrease the bacterial burden in the lungs of Pseudomonas aeruginosa.
And then Luca and associated clinical net pattern, because that would be improvement in lung function and quality of life indicators for these patients.
Great. Thank you.
Okay.
You bet.
Thank you.
Our next question comes from the line of Cana, Cai with Chardan capital markets. Please proceed with your question.
Yes. Thank you good morning.
Jonathan.
I'm wondering what else you can tell us you've learned.
In evaluating the phase one data from <unk> years ago too.
Good question Kay I think there are two big outcomes.
The phase one.
The first one is that we can deliver high levels of phage to the Gi track.
And that we have confidence in the therapeutic window, meaning we're getting levels of phage, which are a thousand times higher than the levels on target bacteria right in our benchmark was to be around 10 times the level that youre at the guarantee enough stage for killing we're seeing the phase stick around for a few days in the Gi track longer I think that weird.
On the anticipated so I think that provides a good therapy.
Therapeutic window and moving to the phase <unk> phase Iia.
Secondly, and I think Thats the point that exact is most is that in <unk>.
Oh, two that was used in the first in human study, we actually had.
Aphasia was more sensitive to the acidic environment.
<unk> and a feature was less sensitive to the Gi tract and that was what we've anticipated both stock based on the platform, which as you know of course a set of.
Computational algorithms in vitro systems that we put together.
Cell based systems.
And we've actually seen exactly that in the clinic, meaning that the more sensitive phage seem to be the greatest slightly more in terms of tighter. So it's tighter was slightly lower than the more resistant strains on more resilient one was actually an higher titers and the numbers in the ratio made sense. It was exactly what was anticipated by the platform.
So I think it gives us confident that as we target other programs in oral delivery will be able to tease out which failure can be resistant and sort of achieve the same therapeutic window that we saw on this study.
Okay. So so based on what you learned here.
How is that possibly informing.
Design.
The net.
Next would be two way for 003.
So I think with that we know that the dose should be sufficient right. So we don't need to do anything fancy to try to increase the dose we don't need to dose it in a more frequent manner because we have this.
Very good half life in the GI track. So I think it basically gives us green light to move with the current dosing paradigm, where the current formulation.
And the dosing frequency right. So now I think we want to pursue patients but have levels called CLO and want to see whether we can pick up reduction.
I hope that addresses the question.
Okay, let's switch to atopic derm.
And.
While targeting a different bacteria. Obviously then asked me.
And.
I'm just wondering what have you learned in terms of the.
Topical formulation.
That youre using for 001 in acne, where perhaps.
Need for the phase II to go deeper.
And how in any way youre applying those learnings at least in terms of yours.
[laughter] knowledge gained with the topical formulations for for <unk>.
005 for <unk>.
Right. So I think atopic derm is a program we're very excited in the testimony of the strength of the bolt platform right. We've initiated the program literally in November last year.
And we're moving forward to launch a clinical study that will have a readout.
In the first half for next year on.
All of the work that we've done the same as what we've talked about on the phase one <unk>. So all the algorithm to tease out which phase you're going to be more stable topical delivery. All the work on formulation dosing regime. The fact that we know how to take out bacteria on the case of acne enables the translated very quickly and just you know kind.
Zip through.
You know already having a cocktail candidate, which is ready to go pursuing now manufacturing and gearing up for.
For dosing and you know that that's sort of the excitement I think of using phage and having the bolt platform because as the company now we can deliver for substantial clinical readout in the next 15 months right. Two of these readouts were not there in.
In November.
So I think that that's kind of the excitement and again, we look forward to potentially even in the future brought on the pipeline even further.
Because once we have all these fundamentals in place we can just start churning out program for program. Once once things are in motion.
And then just a final question for for everything coming off from the bolt platform.
Zero Zero zero zero 005.
What are the remaining task left to do before you actually begin irrespective click.
Clinical studies for each of these.
No.
Just a clarification you mean, Oh currently you mean with our current pipeline what are the next steps.
Yeah.
Yeah.
Got it so I think we now have right for clinical candidate for all of these programs have been announced so that means we have a feed cocktail.
On the looks good and is ready to go it's now basically in steps of manufacturing again as a reminder, part of the bolt platform is actually the in house manufacturing capability, which is also key to moving so quickly right. We are not affected.
In a major way by COVID-19, we don't have we're not relying on external vendors that are swamped manufacturing vaccines and we can do these things in house. So basically it's in house manufacturing getting everything ready both drug product drug substance getting the clinical design the regulatory blessing and then moving to a clinical study.
Okay, great. Thanks.
You bet.
As a reminder, if you'd like to ask a question you May press star one from your telephone keypad.
Our next question comes from the line of Joe <unk> with H C. Wainwright. Please proceed with your question Hey.
Hey, guys good morning.
Let me continue with bolt. So I was just curious obviously you have the great advantage as you just said Jonathan about the in house manufacturing was looking to see if you can add some commentary about the bolt advantages leading to the rapidity that you've seen to be able to deliver zero zero 005 in such a quick manner.
<unk>.
Yeah.
Got it good morning, Joe.
So I think it is you know we've invested heavily over the last five years right and bolt to your point, it's not only the in house manufacturing, but it is actually buying from attics AR, which is crucial.
Because a lot of times, we do a lot of analysis on the target bacteria on the page on the host there is.
A big chunk, which is synthetic biology, a lot of times, we work either on the page or on the host bear in mind that day.
Or is it to move so quickly we can't work with post which are you know your standard PCC, because we're screening things from patients. So we need to have capability to engineer those as well.
And then the teams that are doing assays in microbiology that have been doing it now for a while gained a lot of experiencing are relying on all the know how and IP from.
Both the Weizmann Institute and M. I T and basically that's what we're seeing is kind of moving faster and faster as these guys. Just know what theyre doing and they are just becoming more and more experienced in it.
Got it no. That's helpful. Thank you and then just switching over to Acme.
Just curious if you can provide maybe not numbers, but sort of how the enrollment traction is going right now and are you seeing any impacts with regard to the I guess, let's call it the volatility volatility of different regions.
Covid.
Sure I'll, let you address the question.
Thank you Jonathan.
So this day.
Based on study anatomy is a single center study and Fortunately, we have not seen.
Any impact of COVID-19 in that particular region, so far and enrollment is definitely on track.
To deliver top line results.
Plant.
Great and then my last question, if you don't mind and this is actually.
A forward looking statement, so bear with me when you're looking for.
Program called the lawyers yeah absolutely.
With regard to other colorectal program.
Really quite exciting to be able to arm phage as you alluded to today also on your press release and your prepared comments.
Is this a program type of program or platform that you would look to try to hold on to as long as you can versus staying to your core principles and sort of the anti <unk> effect infective arena or just sort of how do you look at it from a long term planning.
Including BD.
Yeah.
Joe I think it's a good question because it's really a program we don't spend enough talking about and we're actually very excited because the.
The team has done spectacular progress in terms of synthetic biology, right and these are not trivial things think about debt all the tools that we're usually used to in microbiology are all around the E coli family.
The target for <unk> in colorectal cancer Foods I'm curious why didn't ask your bacteria right. The team that's been working north of two years to kind of crack the code and they've done it and Theres a lot of supporting data for the role of the bacteria in the presence of the bacteria and the potential benefits of adding a payload. So I do think it is a very.
Valuable program that can deliver a meaningful impact to patients.
I think what's unique here is that if the concept works right. There are other tumors that actually have bacteria in them. So that's going to give us a lot of of flexibility right you could decide to partner maybe on one type of cancer take another type of cancer by yourselves.
Maybe try the first one by ourselves and partner for the future ones. So again, we don't know at this point, but it is a really broad indication and there is a reason, where we're kind of keeping it and investing in it.
Because it's a huge unmet need and there's a lot of potential that's truly differentiated approach in oncology.
Got it thank you Jonathan.
Joe This is a soft to add on debt from the business development for our perspective.
Perspective, we're currently focusing on mainly generating the in vivo data in the next few months and being able we are today announcing that we've already engineered an IL 15 payload.
For the phage.
Eventually just as a reminder, the intent is to treat patients with this therapy together with checkpoint inhibitors. So eventually this will needs to be coupled with a <unk>.
Existing products that currently pharma half so as Jonathan alluded, we can potentially partner on some applications of cancer on the <unk>.
Certain malignancies and on others tried to develop them ourselves.
Thank you.
Thank you at this time, we've reached the end of our allotted time for questions and answers and I will turn the floor back to Jonathan Sullivan for closing remarks.
Thank you I think I want to thank all of you for joining us. This morning, I want to thank our shareholders for their support and confidence in our work. Our researchers are hard at work advancing our clinical studies and of course, the patients who participated on them. Additionally.
Thanks for bionics team for their dedication and ingenuity. Despite the challenges that 2020 and post have a wonderful day and please reach out to US if you have any question.
Thank you. This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation.