Q3 2020 Biomx Inc Earnings Call
[music].
Hello, and welcome to the Biomets third quarter 2020 results conference call.
This time, all participants are in listen only mode.
Sure. That's a session will follow the formal presentation.
If I did want to require operator assistance. Please press star zero wider telephone keypad. As a reminder, this conference is being recorded its now my pleasure to turn the call over to Barry to Wilson Senior Vice President Finance and operations disposal. Please go ahead.
Good morning, everyone and welcome to the Bionics third acquired 2020 financial results update conference call.
Yes, when he became available subject dexterity and <unk> eastern time today and can be found on our website by almost dotcom.
A replay of this call will be available on the investors section of our website.
Before we begin I'd like to review the Safe Harbor provision all statements on this call that are not factual historic statement, maybe deemed forward looking statements for instance, where you think forward looking statements. When we discussed on the conference call I continued leadership position that commitment to develop treatments that may be beneficial could.
Asian potential opportunities and benefits of the bolt platform successfully reaching near term and other milestones our development plan the expected timing of initiation and receipt of results from our various preclinical and clinical studies as well as the acceptance every military agencies of the design there.
I collaboration, but burn gas engine, <unk> and the potential thereof.
Sufficiency of existing cash cash equivalents and short term deposits to fund our current operating plan committed 2020 to access.
Except as required by law, we did 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 today are Jonathan Solomon Our C O Assaf Oron, our chief business Officer, Dr. saw the Jack Putin Glenda I Chief medical.
With that I will turn the call Jonathan.
Thanks, Maria and thank you all for joining our call today.
This is truly an eventful and exciting time for bionics.
We recently initiated our second clinical study, which is our first under and.
I forget shown new drug application and.
And recently announced a new collaboration with Burger Ingelheim for biomarker discovery IBP.
Today, we are pleased to announce the unveiling of our bolt technology platform.
I just want the addition of two new development programs leverage our fates technology platform.
Better potential therapeutic solutions for cystic fibrosis and atopic dermatitis.
Our achievements demonstrate our continued leadership in the field the state's therapy and our goals show an ongoing commitment to developing treatments for chronic diseases, where technologies can have a transformative impact on various standards of care.
The new research and development platform, we are describing for the first time today, our bowl platform stands for procure phage lead to treatments and incorporates our experience over the past five years with the process, we're finding an implementation of technological advances.
This platform will enable by on extra rapidly that's.
[noise] manufacture and formulate phage therapy candidates targeting particular pathogenic bacteria.
The platform is unique employing cutting edge capabilities across disciplines, including computational biology, microbiology synthetic engineering unique assay development manufacturing and formulation.
To allow agile and efficient development of speech therapies.
For a given indication the platform will allow the completion of a clinical proof of concept study in patients, meaning phase two results with approximately 12 to 18 months from project initiation.
[noise].
This projected timeline for evaluating the efficacy of our treatment patients, it's highly compressed when compared to typical development timelines for novel Therapeutics.
Nickel timelines usually involves several years from program initiation before evaluation of the new candidate in patients it's even possible.
The accelerated.
Timeline will be possible utilizing the bolt platform due to sit parallel development of the personalize fate treatment and a fixed based therapy cocktail rather than a sequential profit.
The bolt platform can be used to generally personalize fate treatments tailored to target specific journals.
Strains in a particular patients.
This platform takes advantage of the well understood compelling safety profile of naturally occurring phage do.
The FDA guidance, we see this part of our IB program targeting Klebsiella.
We believe that this approach will allow us to bypass preclinical safety studies in healthy Volunteer studies and proceed Sir.
Great to studies in patients.
At the same time, while the personalized treatment is being tested in patients. The bulk platform is used to compile the information for the design of the fixed phage therapy cocktail to be used in a broad patient population.
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With the efficiencies realized with the bolt platform approach, we are able to add two new programs each with clinical data readout expected within approximately the next 18 months.
Without impacting our existing projections for cash runway.
Okay.
To be specific the first.
These additional program is focused on the treatments of infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis.
And the second program is targeting Staphylococcus auris for the treatment of atopic dermatitis. These.
These indications represent areas of clear unmet need where phage therapy has a significant promise.
I'd like to briefly review a rationale for initiating these programs and then we will provide an update on the status of our existing development candidates.
First I'll address the cystic fibrosis program.
[noise] infection with Pseudomonas aeruginosa is the main contributor to morbidity and mortality.
[noise] and cystic fibrosis.
These infection, usually start in childhood and according to publicly available sources are estimated to affect 50% of the 80000 patients worldwide with cystic fibrosis tip.
Typically prolong their repeated course of treatment with broad spectrum antibiotics lead to resistant to antibiotics and deep.
It's a multi drug resistant strains.
Relative to patients without some of those are getting outside.
Patients with chronic infection show more steep decline in lung function, a higher number of episodes of acute worsening of symptoms called pulmonary exacerbations more hospital admissions and increased risk of mortality.
Page therapy presents a major opportunity to benefit patients who have experienced failure of existing treatment as well as potentially complement current treatment options targeting antibiotic resistant strains and break down the biofilm thick mucous produced in the lungs obscene Wanna sorry, he knows the colonized patients that contributes to antibiotic resistance.
We are currently engaged in designing a clinical program with the goal of reporting results. The phase two proof of concept study in the fourth quarter of 2021.
The company also applying both platform to the development of a topical phage cocktail for atopic dermatitis.
This product could provide significant benefit for patients who are not candidates for systemic therapies, including patients suffering from mild to moderate disease and pediatric patients seeking to enhance safety profile of our products.
The relationship between atopic dermatitis and skin Viekira has led to different antimicrobial treatment approaches.
The bionics atopic dermatitis program target Staphylococcus Auris Ebix your thought to contribute to the development exacerbation of inflammation in atopic dermatitis.
Staphylococcus or is also increases in abundance, becoming the dominant secure when patients experience flares bye.
By reducing the load staff for us our phage cocktail.
Those intended to shift the skin microbiome composition to its pre flare state.
Results from Phase two proof of concept study and atopic dermatitis is expected in the first half of 2022.
We are excited to move forward with these programs on these.
The new indications our ability to initiate these programs deliver clinical readouts within 12 to 18 months without reducing our cash runway demonstrate the efficiency and versatility of our both platform.
I'd now like to turn the call to our Chief business Officer Dr.
I want to briefly address the market opportunity around these two new programs and provide a business update.
Thank you Jonathan these two newly announced programs substantially increase the commercial opportunity of our product pipeline. We also strengthened our company.
Nick meant the chronic indications, where phage therapy could have a meaningful impact on patient care.
Publicly available sources indicate that the global market for cystic fibrosis therapies was over $5 billion in 2019 and is experiencing steady growth the adoption of recently introduced therapy.
These two improved trafficking of CSAPR proteins has improved quality of life for CF patients. However, chronic antibiotic resistant bacterial infections upset them on this the rig and that was up eventually develop in the lungs of most patients. These infections remain a main contributor to morbidity and mortality.
Patients treated with newly available medications phage therapy could be transformative to the lives of these patients and we believe bionics is well positioned to address this opportunity.
In atopic dermatitis publicly available sources estimate the global market for therapeutics.
Right over $3.5 billion in 2019 and is also experiencing steady growth with the introduction of new therapies.
Notably approximately 35% of the over 25 million U.S. patients with atopic dermatitis, our children, while injectable biologics have trends.
Foreign treatment for patients with severe atopic dermatitis, there is a clear need for efficient topical therapies that have a positive safety profile and avoid side effects, especially for children based on the potential contribution of staff or is the development and exacerbation of inflammation and the top.
Popick dermatitis and the compelling safety profile of phage, our proposed treatment could address a substantial market opportunity.
In addition to internal programs and the advancement of platform technology by Omics continues to demonstrate leadership into microbiome space with its not all computational biology CAPL.
These in September we entered into a collaboration with bare and give any real time to work towards identifying biomarkers associated with patient phenotypes and IBT our role in the collaboration is to generate mid of genomic data of gut microbiome samples and use our ex marker computational platform to Anna.
Allies that data.
Collaboration includes an option for Burger angle line to negotiate and exclusive rights for use of the Biomarkers discovered as part of the collaboration the X. marker platform also supports our internal pipeline and we're proud that Burger Ingelheim has recognized our cutting edge computation.
Bill analysis capabilities.
Thank you Asaf.
Beyond these two new programs, we continue to make progress with our existing pipeline of phage therapy candidates.
Early this month, we dose the first patient in our first in human Pharmacokinetic study phage therapy designed to target the clubs and pneumonia.
With a key exploratory endpoint as an assessment of delivery of viable phage to the gastrointestinal system business.
Results from this study are expected in the first quarter of 2021.
Furthermore, our bowl platform has enabled us to overcome one of the key challenges of based therapy.
And produce an extremely wide host range page Clarksville.
This new product simultaneously target coffee on pneumonia strange associated with inflammatory bowel disease as well as primary school sudden calling China's it is now named the X double O three and is expected to generate results from the phase one day to a study aimed edit valuing the efficacy a big stubble three and redux.
<unk> of target <unk> by mid 2022.
We believe 2021 will be a concern of year for bionics do.
Do do significant expected clinical readouts.
Starting with P. K studying IBD in Q1, thin acne and made 2021 and insist that group grossest a year at.
The master owns will be closely followed by the first half of 2022.
Additional readouts expecting a programs within the topic dermatitis and Ivy D. P. S C.
And now like to ask Marina Wolfson, our senior Vice President and finds an operation to cover a financial results for the quarter.
Thanks downtown as a reminder, would have financial information is available that's fine. Thank you, which will be found today I'll briefly touch and a few highlights.
Cash man and shake and deposits.
30th 2021 $64.5 million compared to 82 point funding die as of December 31st 2019.
Research and development expenses was six point appointment <unk>.
<unk> of 2020 compared to $2.9 million in the same period of 2019 to increase is primarily due to grow to the number of employees, which resulted increase of salaries and related expenses and you did depreciation and amortization expenses.
Yeah, the administrative expenses wait $2.4 million and the third quiet of 2020 compared to one eight <unk> in the same period in 2019.
The increase is primarily due to expenses associated with operating as a public company, such as directors and officers insurance filing an legal and accounting expensive.
That's lost it was $8.8 million in the third quarter of 2020 compared to $4.3 million in the same period of 2019.
Net cash you as an operating activity with $17.3 million for the nine months and the September 30th 2020 compared to $10.5 million in the same period of 2019.
We estimate that existing cash cash equivalents and short term deposits will be sufficient to fund the company's current operating plan to them in 2022.
<unk> with now like to open to call up for question operator.
Thank you and I will be conducting a question and answer session if you'd like to be place in the question to please press star one on your telephone keypad, a confirmation code will indicate your lives in the question queue. You May Pro star too if you'd like to move your question from the queue for participants using speaker equipment it may be necessary to.
Pick up your handset before pressing star one one moment. Please what were you pull for questions.
Our first question today is coming from kidney came from Florida and your line is alive.
Yes. Thank you can you hear me.
Hi, there.
Yes, Jonathan.
So some questions on the new bold platform first just going back to the.
The ability to progress faster in your clinical trials towards proof of concept.
So based on your conversations with the F D. A and what gives you the confidence that you can skip over some of the normal [noise] early phase one safety data capture in a normal healthy bowling chairs.
Sure. So thank you K a it was a pleasure I'll, let silence to address the first question.
Yes, Thank you, Jonathan and Hello, K Uhm, so given that most of our pipeline programs involved wild type page and not engineered page uhm the guidance that that may be saved from the F. D. A indicates that because of the extensive.
Safety profile off Wildcats age there is no need to do G. O P talks and animals and then it may not be meaningful to do help you Wanna do studies than your typical pays one situation in people without the target bacteria. So there is precedent and guidance from the up to a where we can.
Can proceed to phase two and patience without G. O P animal talk Sir I'd like your standard things 115 healthy volunteers. If we are using one type page, which most of our programs are doing.
Okay and for C S talk about.
The type of cocktail, you'll you'll utilize how quickly are you going to have that available.
And I.
<unk> well, let's start there.
Can you further described at the cocktail afraid just you'll be using here.
Sure that so I think that's an excellent demonstration of the bold platform. This as a cocktail that we've launched internally very very recently, we already have page candidate that look very good and have very broad coverage that is moving to a personalized.
P O C and will already estimate to have results within the end of the 2021 and I think that's why we're so excited.
And and ultimately.
How do you envision your approach to address bacteria.
To be used and perhaps combination with with other you know so you have to your modulating therapies.
I'll, let us up address that high K, So I mean.
250, or modulating therapies have been transformative for C. F patients most of the C. A patient Cindy U S. Today you these drugs.
Or wherever still be infections that occur in their lungs, there's still a very high rate of C. F patients that eventually in their lifetime start having pseudomonas infections.
At the early stages antibiotics are effective but as this progressive and there's continuous infections.
There's antibiotic resistance and also accumulation of biofilm. So I think this issue remains a key topic. We know also that for the C. I a foundation. This is a key aspect so that remains as an unmet need for C. F patients. So we.
See this type of therapy actually being a coupled with the C. F T R modulators.
So in your initial study will you target those who have.
Your feeling on some combination of C. F T R.
And then secondly, you you did mention to see a foundation what what is your involvement with them today.
I can let solid your address.
Thank you Jonathan.
Uhm.
So in the first study we are going planning to target patients with cystic fibrosis, who have chronic seven one is infections and those whether they are most have been tend to be multidrug resistant that they don't have to be in the first in the first may put study and whether patients I'm taking C. A T.
Would you later, so I'm not <unk> is <unk> is imitator light pink as long as they have comics at a motorist infections, we wouldn't let them in the first study.
But <unk>. It is early stages and we used in that tweaking. The design. So we'll have more definitive guidance later on it.
And in terms of the C. A foundation, we have initiated that conversation with them to to try to work in conjunction not only on the chemicals design. This study, but also in other aspects of the development program in terms of acquiring resistant strains. So they want us to test our faith, John and such and we all look.
<unk> forward them to continuing to work with them as we develop the chemical design for the first study and then the developing program as a whole.
Okay.
For now let me just I'll go back into your.
Yeah or.
Thank you as a reminder, that starwood to be placed in the question. Hugh Our next question is coming from Kristen Costco from cancer Fitzgerald July does that lives.
Hi, good morning, everybody. Thank you so much for taking the questions and congrats on the progress so for the cystic fibrosis infection program with the Golby to eradicate the bacteria or to make the bacteria sensitive to these antibiotics rather than resistant to you know allow for eventual treatment again.
I'll, let soldier again comment on on the clinical thinking.
And thank you for <unk> Jonathan later.
[laughter] didn't want interesting.
Thank you for the question too so the in in the very first proof of concept study insistent purposes, the goalie be to demonstrate reduction of the back pain and burning up pseudomonas because historically reduction of that back pain and burden has been associated with chemical in two minutes, specifically and if maybe one.
So that will be the <unk> off the off the first study there.
Did you have a second question system I'm sorry.
No I was just asking like if ultimately the goal is to try to eradicate the bacteria or you know and and this is my follow up question, but you know there have been instances, where the specter has been looked at N C F before through compassionate use specifically for cystic fibrosis and I.
<unk>, you know and some of those instances it it was deemed successful because it allowed the feet allowed for the bacteria to then become sensitive to the antibiotics that they were able to eventually got these treatments enough you know clear the infection. So you know I guess, there's a couple of different outcomes here and you know, perhaps each of them would be <unk>.
Last fall, but you know ultimately what would be you know your main goldner this approach.
Yes, Yes, I go absolutely. The main goal the main goal would be to demonstrate a deduction in the back to button, but of course, there's plenty of data that suggests the mechanism of action of stage also meet me restore susceptibility to antibiotics to which the strain was for them to be resistant before so we will be looking at that.
At that capability as well.
Okay. Thanks, and then just kind of following up on that no can you talk about what you would view as some of the key takeaways ahead of you know your understanding of this being looked at through stage before you know I know for acne for example.
While you were really the ponies pioneers excuse me here for demonstrating that but in this instance, there's already some evidence out there in the field stupid through these compassionate studies that would be great to kind of hear your thoughts and takeaways from what you've learned from you know some of these published case studies.
Sure.
And I'll say, hi properly person. So I think what makes US excited is exactly the point that you brought up there are case studies that have shown successful deployment of face therapy in C. F patients right. So in some ways. It gives us comfort that the probably a success here is higher it still remains an unmet need.
Because these are as you said, it's anecdotal cases, where you know beige cocktail, where customize with specific patient here one of us the breath of the bold platform and I think all the experience that we've learned through the years to produce.
In the end, a cocktail which is optimized in a suitable for their broad population and maybe it could use can be used even as the first line of defense right and not expose these patients that so much antibiotics and have the pages as the last the last rescue possible.
Okay that makes sense could you remind us about you know your stage bank right now the you know the totality of the data there and then you know.
I know in some instances you noted that you might need to identify new phage and you know that's included in the six to eight week lamp that you provided through the bolt platform. So maybe could you talk about you know in those instances, where you do need to identify new phage, whether you have all the right tools and whatnot in place to go out there and do that.
Right. So I think after five years of.
Substantial investment and feel very confident that we have all the elements right. The bold platform. There were unveiling today is actually the collection of elements of identifying foods characterizing phage manufacturing it putting together all the Aussie So that's one in place.
I would say it sometimes it depends on on material right some mature faster and some of your slower in the case of C. F. I feel very confident in literally from the work that we've done it just in the very short periods since we've launched.
Launched a project we already have multiple candidates that are starting to look good.
Okay. Thanks, and then the last question for me is on a topic term. So I'm just noting that these levels of S. R. S are greater and patience in general, but also you know one in the disease flared States and then two for those that have worst severity. So I.
I wanted to ask how you might envision the usage of such a therapy. So you know would this be used as something chronically to try to prevent the 80 from worsening or you know do you think this could also be used in situations where patients are happy with their current treatment options, but they still experience the flare ups, where they might need you know a treatment like.
This and then also that know given that we've seen you know success of do picks it across a number of different indications and it's well known that a lot of these patients might experienced asthma and different type of allergies, how you might be thinking Big picture, you know long long story about the potential here and some of the other.
<unk>.
Well I'll, let us up address I think the specific topic damn I can comment and then the general thinking.
I think.
I think the first the systemic injectable dubik since there's really transformed also the topic term market, but it's mainly for severe patience and there is also issues of trying to treat mild to moderate in specific specifically children population still with topical therapies that don't have all the <unk>.
Side effects and safety aspects that injectable stomach therapies half. So we think many others think that there's a lot of room for other solutions in the market and as you've noted this therapy could be topical it's very safe it could be relevant both for cases, where the flare.
Blair, where you could decrease the amount of the bacteria that supporting the exacerbation of the disease, but because of the strong safety profile of face this could potentially be something that could be also treated used chronically by the patients to potentially avoid flares again, one of the reasons of doing the proof of concept is to learn more about.
The magnitude of the effect of treating patients and flair with this type of therapy.
And just to your broader question I think the elegance of the bold platform is that we can move so quickly and get a proof of concept. So if you're looking at another indication or are you thinking hey, I'm looking at.
Certain times of immune related disease, and we think there's another vicarate play we can actually test it out very very quickly and the risk the program in unparalleled theme. So I think we're looking at deploying the bold platform to answer these questions and.
And basically the with some new programs very quickly as well.
Great. Thanks, so much.
Thank you.
Thank you. Our next question is is the follow up from Kim K from Friday in your line is L y.
Yes, thanks, Yeah, some additional questions.
The topic germ first of all Jonathan in this case the the cocktail.
How many different phases do you imagine you might need in order to have something that is is is broad enough for the the university of [noise].
Uhm step already.
So we typically don't disclose the number of fades in a cocktail, but I think you're hitting the nail on the head in terms of the question right. There is always one of the key challenges is to obtain abroad how strange.
Also and stuff or if we've done some work and we're very encouraged and we have candidates. If he's had very broad housetrained and I would say I think I think that both platform Iraqis shown its power because if we think about fluffy all of it here that's actually one of the toughest bacteria to have broad hosts range because of the diversity of the bacteria.
And we've made so much progress and launch big So three that has spectacular coverage among the strength, we feel confident we could do the same in stop or it's another.
Yeah.
So so again for.
A topic germ.
Who would you like to initially targeted your proof of concept study <unk> will it be patience.
<unk>.
Are experiencing a flare.
Would you also.
Want to target pediatric patients initially you're getting just given the.
Uhm concern of parents not to put him on something systemic and obviously be concerns about steroids.
Sure I'll, let Tyler to address that.
Yes. Thank you Jonathan so in the initial proof of concept study we plan to enroll.
Patients who have tough alright, so obvious to me and said, though and we know that the headlines of Stefan Yes is higher in patients with flair and also in patients with severe a topic dermatitis, but the but the absolute requirement will be patients that are cognize with Stefan yes, and that took a concept study and the question.
And my pediatric patience with atopic dermatitis is it is it really interesting one tape because again I think the disease is more prevalent and kids and I think this is one area, where you can in town and <unk> pediatric patients as well as adults as opposed to the.
Monday indications when you have to initiate that split studies in and out so we'll be looking at that too as we go forward.
Okay, and then just back to.
The bolts platform itself no given the the ability to perhaps more quickly have a personalized form.
<unk> P. How does that play into your your longer term.
You know thinking in terms of of commercialization strategy, where you could actually utilize the capability.
So the way the platform works is that it works in parallel right. So there is one path in which we're working on a personalized therapy, meaning.
That for a specific materials strain and a specific patient we are manufacturing in house.
A cocktail suited for that specific patient, let me do it for like every single patient then enrolled in the POC study and that's driven by all of the increase in manufacturing capacity asset capacity. The tools that we have on board right well that takes place. This period of 12 to 18 months in which we're kind of running through the pie.
<unk>.
And are treating every single patient in the meantime, we're acquiring more materials transplant patients and more phage right and these are all fed to the other part of the bulk platform, which produces an optimized stockdale that has a very broad hosts range. So by the time by the time, we finished the P. O C. A few months later we.
Already have an optimized speech cocktail, which is relevant for abroad, how strange.
Of the girlfriend from different patient and that product can move forward to the pivotal study.
Okay. So so again that kind of just touches on your earlier comment Jonathan about how you're collecting data.
You said, you'll actually this approach with each patient.
So and he's early studies that is designed to ultimately.
Uhm allow you to tweak the clock til to come up with the the doctor much for.
Spot on.
Spot that's exactly what we're doing and we're kind of doing and in parallel we realized that because of all the progress.
We can we can treat one patient after the other and then form and produce and the end and optimized parkdale. After we have all the information while.
Be risking the program and getting a proof of concept then patient.
Okay, great well it sounds very intriguing in announcing it today you know I guess, one would assume that both of US is ready to go but you know is there are other aspects of the platform that.
So I'll need to be.
Further validate it or where where would you say it stands in terms of its its readiness.
So the platform is actually ready to go up and running.
I think all through the last few years elements of this platform was put to use right whether it's the by informatics the generic toolkit.
That we characterize all phage, so we've manufacturer face which are already in the clinic.
And we're dosing patients with face we manufactured ourselves.
We have all of the acting characterization capabilities in house as well. So all these elements we're actually.
Built in house and deployed over the last few years now we were able to kind of put everything together and have it run and have it run in parallel we've talked about because everything now.
Is working and we could actually scaleup assay and manufacturing capacity and that drove the.
The capability to kind of do all these things in parallel.
Okay, alright, well with that thanks for for all the time here.
Thank you for the great question.
Thank you, we reset of our question and answer session.
The floor back over to management pretty further are closing comments.
Thank you all again for joining us today for this update our progress as a result of the efforts and many individuals the hard working employees that the company the researchers who support our work.
Participants there are clinical studies and our shareholders. Thank you for your contribution to our vision of advancing phage therapy enabled by new technological tools and a solid history of scientific exploration may be safe and have a pleasant thing.
Thank you that does conclude today's teleconference. A webcast you may disconnect. Your lines at this time and have a wonderful day, we thank you for your participation.