Q2 2020 Biomx Inc Earnings Call
Hello, and welcome to the Bionics second quarter 2020 earnings Conference call. At this time, all participants certainly listen only mode. That's pretty watch require operator assistance. Please press star zero under a telephone keypad a question answer session will follow the formal presentation.
As a reminder, this conference is being reported.
Pleasure to trouble pull over to <unk>, Vice President Finance and operations. This Wilson. Please go ahead. Good morning, everyone and welcome to the bail me second quiet 2020 financial results update conference call. The news release became available just after 630 am eastern time today can be found on our website.
Bionics Dot com.
A replay of this call will be available on the Investor section of our website.
Before we begin I would that can be viewed safe harbor provision.
All statements on this call that are not factual is twice statements maybe deemed forward looking statements for instance, where are using forward looking statements. When we discuss the conference call unlocking the potential in speech therapy is successfully reaching your Tam other milestones I development plans and timing of clinical studies.
The wind wage of indications in which faced pepys can be applied and the sufficiency of existing cash cash equivalents and short term deposits to fund the company's current operating plan to mid 2022.
Except as required by law, we do not undertake to update forward looking statements. The full safe harbor provisions, including risks that could cause actual results to differ from these forward looking statements are outlined in today's press release, which as noted earlier is on our website joining.
Joining me today, I, Jonathan Salomon, I, CEO, and Dr., <unk>, but again I Chief Medical officer with that I will turn the call to Kathryn.
Thanks Maria.
Thank you all for joining our call today our goal it all makes its to unlock the potential phage therapy. That's the technology driven decision medicine approach and we're making significant progress this endeavor as evidence disappearing.
Relation of the microbiome couldn't be potentially transformative clinical outcomes.
Take care of phage, our viruses that can be used to advocate specific pathogenic bacteria without disrupting beneficial bacteria.
Our position as a leading developer speech therapy. The result of both of our ability to identify areas for at this approach has distinct potential to meet unmet medical need.
Wow, that's her deep expertise in microbiology synthetic biology, computational biology, which we use it precisely customize combinations cocktails specific phage.
Our French cocktails contain multiple phage what complimentary functions.
<unk> through in vitro in vivo casting.
We are developing novel Therapeutics Usix age in the numbers prescription indications with significant commercial potential, including inflammatory bowel disease and the rare disease primary sclerosing cholangitis and colorectal cancer.
Addition, with our recent successful demonstration of the use of speech reduced levels of good cubic Jeremy Shockey CEOC. Neither curious on the skin, we are developing phage therapy as it gets medic application to prove the parents have actually grown scale.
Now I'd like to review the status of our development programs, well then focus on the detail of our near term upcoming milestones.
Our lead candidate VX tableau, one is a speech therapy cocktail targeting fee acne, which are big if you're a implicated in the pathophysiology Aki Bulgaria.
In March we announced that Bx tableau, one demonstrated a positive safety profiles and statistically significant you do see ACMI levels, which has allowed us to decide to phase two study.
The phase two study is designed to enroll 100 individuals with mild to moderate acne and evaluate daily administration of Bx double a one over 12 weeks.
Endpoints or this study will include safety Tolerability reduction of see academic year old burden and devaluation of the effect on completions on the face.
We expect the study could it get him his first quarter 2021 with results expected in second quarter 2021.
[noise] RPX double or two programs for the treatment on inflammatory bowel disease or IBT.
He is on track to begin clinical development. This quarter would the initial goal of demonstrating the ability to deliver Bible stage at the lower gastrointestinal tract.
We recently completed in house GMP manufacturing, but the phage support this phase one a study.
This is a significant milestones and the facility could not support multiple clinical trials civil tediously.
We expect to report pharmacokinetics and safety data from this phase I want a study by the end of 2020.
This study will inform the design of the phase one beat you a study aided the value with the efficacy of be accessible to and reducing the target Victoria coffee on ammonia, which has been shown to be proinflammatory in animal models. We continued to plant to initiate the phase one beat you eight study in 2021.
The fringe cost for the treatment of the rare liver disease primary sclerosing cholangitis, where PSC.
Shared the same to kill target as the IB program and it's also anticipated to be orally administered which allows us to apply the results of the phase one eight studied <unk> D that the design or the phase. Two study you see we continue to work toward the initiation of phase two study PC in 2022.
In colorectal cancer, we are exploring the potential for speech therapy to deliver therapeutic payloads to procure residing inside tumors. Our goal is to provide preclinical proof of concept results in the second quarter of 2021.
For this application of our expertise in synthetic biology for stage cocktails.
As you can see that thinks it attributes of speech therapy provide opportunities for the dominant a wide range of indications.
Each of these programs relies on our strategic selection of key indications with compelling commercial potential we're phage therapy could happen to transport, but they've got.
As we near the introduction of our second clinical program with the initiation Bx tableau to phase One day study, we would like to provide some additional detail on this study.
I would now like to ask Dr. <unk>, our Chief Medical Officer, which provides additional information on the details on the study design.
Thanks, Jonathan.
The Big W. Two phase one these studies are expected to be initiated this quarter, we'd be conducted at a single site in the U.S.
This is a randomized multiple dose study designed to enroll 18 adult healthy volunteers 14, deceiving B S. W. Two and four deceiving because people will that be day period.
The primary endpoint of this study is to demonstrate safety and Tolerability of BMW to why the key secondary endpoint is to demonstrate delivery. If my book Beach to the new one got.
Oh subjects will be administered code on pump introduced to elevate the P.H. into gastric change.
I'm condition, the environment for delivery of the except there too.
Subjects will be evaluated for the detection of libels agents do over the course of the study and for an additional three days following dosing.
Detection Bibles agents to wouldn't demonstrate that be ex doesn't know too is reaching the newer gastrointestinal tract.
In addition, monitoring the levels and timing of Weibo phage as it is excluded from the body would not only help inform the design of the following phase one beat to East study aimed at evaluating the efficacy of be it doesn't go to introduction of target back Peter never from the got.
But would also inform other future studies that involve ordered administration stage.
This sets the foundation for wouldn't delivery of age and opens up multiple potential future indications with PSC being just one of them.
We look forward to results from the study, which we expect to be highly informative as an initial step into clinical development of be ex W. Two and build upon the state of the Arctic knowledge into feed the speech therapy.
With that I'll stop here and Tom to called Backdoor CEO Jonathan Feldman.
Thank you silent John.
I'd now like to ask Marina Watson, our Vice President Finance and operations to cover our financial results for the quarter.
Thanks, Jonathan as a reminder, additional financial information is available in the press release, we published earlier today as well as our second quarter form 10-Q, which will be filed with the FCC later today.
Cash balance and short term deposits as of June Thirtyth, 2020 was $70.6 million compared to $82.4 million at the end of 29 team.
Research and development expenses were $4.1 million and the second class 2020, compared to $2.9 million by the same period of 29 team. The increase was primarily due to the manufacturing SPX theorize your one and be exit I'd like to the company's product candidates for acne problem.
Skin and I B D prospectively for clinical trials Pepsis.
General and administrative expenses were $2.3 million and the second class 2020, compared to $1.2 million by the same period in 29 team. They increase was primarily due to expenses associated with operating as a public company such as directors and officers insurance finding legal.
The accounting expenses.
Net loss the $6.2 million into second quarter of 2020 compared to $3.8 million for the same period of 29 team.
Net cash used in operating activities was $11.4 million by the six months ended June Thirtyth 2020, compared to $5.9 million, but same period of 2019.
Existing cash cash equivalents and short term deposits I expect it to be sufficient to fund the company's crane operating plan. So mid 2022.
Thank you I will now turn the call back over to the operator for questions.
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One moment, please while we poll for questions.
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One moment, please while we poll for questions.
Our first question today is coming from Chris includes go from Cantor Fitzgerald your widest allies.
Hi, everyone. Thanks for taking my question. So the first one here is I'm wondering there's such a high overlap with patients with P.S. seem to have IBT, whether or not you see any other co morbidities would I be de where klebsiella could also play supporting role.
[noise] I Kristen and good morning are excellent question I think currently these are the two main indication that we see we do think then future we will see additional overlap. So we're actively looking into that bacteria and many other big cure and these different indications.
And think that the will be more indication essentially years.
And I would say there's also you know just the case of resistant clubs yellow, which appear in multiple infections, which could also be a relevant target to expanding the kinda third generation product.
Thank you and then for the proof of principle study thanks for providing some more color today, but wondering if there's trial will include both crohns disease in old search, it's quite patients and whether you see any key differences with the juice the patient population.
So some of the analysis, we did so far the levels of clubs you all seen really close in both patient population. So we think currently a of enrolling both but you know I think we'll make that decision or closer to the clinical proof of principle Oh study the protocol.
South it would like to add anything to that.
Thanks, Jonathan.
At.
The proof of principle, we are sitting.
So during the study design and we know for sure that we will include targeted bacteria carriers, whether those are healthy volunteers or I'd be patients and as Jonathan said.
As far as I'd be patient school. The prevalence is about the same in boats C.D. and you see and said no no reason to exclude one or the other.
Great. Thank you one big question, one Big picture excuse me question.
Like with the Kobin 19 pandemic, there's been a recent appreciation toward the seriousness of anti microbial resistance, especially since it's a growing problem. So first I just wanted to ask if you would agree with the aim it and then I can't how do you envision that speech therapy, and bionics broadly speaking could play a role in the dressing.
So.
I think it you said you said, it's a big question that we've been debating and actively monitoring there are some movements as evidenced by.
The formation of a billion dollar fun to support you know a EMR projects. So there's definitely movement I think we're actively monitoring and work cited as we see development. There because page is a natural tool that were natural weapon to go after resistant bacteria. So there will be applications many of them can be expansion.
Our current pipeline same is yeah to your previous question of club Fiala, You know club you guys actually on the top list of the whr organizations resistant organisms and potential either you know because you're a other indications as we made a lot of progress in establishing the pipeline the platform and feel confident.
There, we can pretty quickly expand and add additional indications.
Thank you and then some of your peers like or buying these have recently announced in clinical data during the summer so while not age therapies, specifically I wanted to hear your view on these results and whether you think there was any read across.
So we did it isn't very exciting time I think we've we've bought a closely and are excited by the renewed interest or across the board and in my provide them I think when we look specifically at the excellent results that we've seen in C. diff.
This is an indication that actually excessive use of antibiotics is led to one because you're kind of ticking over the whole microbiome and nothing can treat it except for a micro by modulation right. So I think this is evidence that there are many cases, where our traditional tool kit is not sufficient and we need something like adding bacteria.
ER or fade should take out the criteria to have a dramatic effect and I think that bodes well for the industry and we're hoping to see more.
More and more these successes and enjoying it you know ride on the on what we have so far and acne and hopefully follow up with exciting data and IBT.
Great. Thank you so much for taking my question.
What was the pleasure.
Thank you enough questions today is coming from Kitty the came from Chardan capital markets. Your line is alive.
Yes. Thank you so for Bx years under one I know you talked about on track for starting a phase II Q War waters with <unk>. Some of the key task you need to complete between now and then Jonathan.
Good morning can so I think mostly we're gearing up in terms of manufacturing and just being ready for the study and putting final touches the protocol, obviously cobot 19 had an impact on the timelines and slots availability at the CRL.
So we're gearing up and once the slot opens up after the delay they incurred we'll be ready to go.
Okay and then.
For below zero zero to again.
For the the next study I know it would be informed by the the PK of the the phase one anyway, but.
Can you talk about both.
How many how many patients you think might be in that next study.
[noise], but without a question on on patient number of patients per study.
Yes, yes.
Yeah, I'll, let a satellite to go into details of our thinking on that protocol.
Thanks, Jonathan.
Hi, Kate So <unk> like you said that the design of the next study the proof of principle study we'd be dependent on a deep pharmacokinetic study, but we are conducting right now but at this point we'd be information we have we're considering enrolling 30 subjects into that study.
I need to be a placebo controlled so 15 on active and 15 RBC, though.
Okay, and again I know little [laughter], you know yet to be determined but are you.
Hopeful that you'll see from the the PK data a single dose that stands out and that's what you would then go ahead and goal.
For the six that's 30 patients or if they if you still won't have that kinda clarity could that study.
Clued, a multiple dose cohorts [noise].
It will definitely be multiple dose cohorts, because we I'm confident about the safety. This is a cocktail of white hyperphagia.
Safety, so it's not going to be a limitation it will be a multiple dose study and.
As I said done one of the previous questions.
We are still considering whether that is going to be a healthy volunteers or a IBT patients and that will determine the duration of therapy has me as we get more information.
[noise], Okay and for the the patients that.
Would be carriers.
What are you thinking about.
The possible inclusion exclusion criteria, especially as it pertains to perhaps other a background that's.
So if it is going to be targeted back to a carriers in healthy volunteers, obviously, those we'd be the standard intrusion exclusion criteria to identify healthy subjects.
And if we do decide it too to look at target bacteria eradication in IBT patients at the at this moment, we don't see any reason to exclude any concomitant medications. If that's if that's the focus if your question K because ER sage.
Can be an adjunctive therapy eventually to a any of the existing IBT therapy.
Yes that was my question. So thank you for for [laughter] addressing that specific point.
That's all I have thank you.
Thanks, Greg.
Thank you as a reminder, that star one to be place and the question Q1 moment. Please what we pull for further questions.
We appreciate about question answer session or the trouble for back over to management for any further a closing comments.
Thank you again for joining us today, we'd like to express our sincere appreciation for the support of our shareholders our employees and patient that participate in or studies as we work to realize the potential phase therapy wish you all safe and Pleasant thing. Thank you.
Thank you that does conclude today's teleconference. You may disconnect. Your lines at this time and have a wonderful day, we thank you for your participation today.