Q3 2022 Biomx Inc Earnings Call
Good morning, and welcome to the biomass third quarter 2022 financial results and corporate update conference call. Currently all participants are in a listen only mode there'll be a question and answer session. At the end of this call I would now like to turn the call over to Marina Wilson, Chief Financial Officer of bottlenecks.
Please proceed.
Thank you and welcome to the Bionics third quarter 2022 financial results and corporate update conference call.
The news release became available just after 630 am eastern time today can be found at our website and bionic dotcom and.
A replay of this call will be available in the investors section of our website.
Before we begin I'd like to review the Safe Harbor provision.
Our statements on this call that are not factual historic statement may be deemed forward looking statements.
Okay.
Forward looking statements discussed on the conference call potential market opportunity.
Zhang and expected timing and interim and final results of our preclinical and clinical trials.
Sufficiency of our existing cash cash equivalents and short term deposit potential.
Potential receipt of additional funds as milestones are met.
Potential benefits of our product candidates and potential growth and shareholder value.
In addition pass preclinical and clinical results as long as compassionate use and not indicative and do not guarantee future success of our clinical trials.
Except as required by law, we do not undertake to update forward looking statements.
So, let's say talking about 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.
Yeah, Let me on the call. This morning is Jonathan Solomon Chief Executive Officer of Thionic.
With that I will turn the call over to Jonathan.
Thank you Marina and good morning, everyone I intend to keep my remarks brief this morning as during the third quarter, we remain largely focused on our ongoing phase one b to a trial a big step below four and cystic fibrosis.
I'll now provide an update on the program.
As announced in our press release. This morning, we made important progress with respect to enrollment during the quarter.
Given the challenges enrolling CF patients in the wake of the COVID-19 pandemic, we've put in place important mechanism to improve enrollment and these specialists are produced a recent uptick in considerable acceleration of big tableau for enrollment trends that will impact those parts of the trial.
They started the latest estimates we now believe that enrollment in part one of the study will be completed by year end.
Get into consideration some modest impact from the U S holiday season.
Extensive data analysis that follows each patient dosing schedule. We now expect to report results from part one of the trial in the first quarter of 2023.
Our results in part two in the third quarter of 2023.
As a reminder, we are developing big sell below four as a treatment for CF patients with chronic respiratory infections caused by pseudomonas, arguing that what you're saying.
Main contributor to morbidity and mortality in patients with CF part one of the trial will evaluate the safety pharmacokinetics and microbiological clinical activity be acceptable for in eight patients in a single ascending dose and multiple doses.
Part two of the trial will evaluate the safety and efficacy of big stay below four and 'twenty for CF patients randomized to treatment or placebo cohort in a two to one ratio.
Last quarter, we highlighted some of the positive outcomes from investigator sponsored clinical trials utilizing phage based treatment modalities to address difficult to treat infections in CF.
We are pleased to see a growing data driven support for the potential benefits of a flying face directed therapies to address these persistence and life threatening lung infections in CF patients.
And we look forward to reporting data from the Bx Tableau a fourth program in 2023.
I'd now like to turn the call over to marine the Wolfson, our Chief financial officer to cover off the natural results for the third quarter.
Thank you Jonathan.
The financial information is available in the press release, we issued earlier today and also in more detail in our Form 10-Q, which will be filed later today.
I'll walk you through some of our brief highlights.
As of September 30th 'twenty, 'twenty, two cash balance and short term deposits were $41.5 million compared to $63 million as of December 31st 2021 please.
We used was primarily due to net cash used in operating activities.
Research and development expenses net were $3 $5 million for the three months ended September 32022, compared to $6 $6 million for the same period in 23 months.
This primarily reflected a decrease in salaries and related expenses and stock based compensation expenses driven by a reduction in personnel as part of a corporate restructuring we announced in may of this year.
Well its pausing the development of zero zero sweep product candidate for the treatment of inflammatory bowel disease, and primarily because I think orange Ida I think the development of our colorectal cancer product candidate and the discontinuation of the product candidate for the treatment of acne.
This was partially offset by a decrease in grants from the Israel Innovation authority.
General and administrative expenses were $2.6 million for three months ended September 32022, compared to $2.8 million for the same period in 2021.
It's primarily reflected a decrease in salaries and related expenses and stock based compensation expenses related to a reduction in personnel.
Part of the corporate restructuring.
Net loss was $6 $8 million for the third quarter of 2022 compared to $10 million for the same period in 2021.
Net cash used in operating activities and $21 $9 million for the nine months ended September 30th 2022, compared to $18 $5 million the same period in 2021.
We estimate that existing cash cash equivalents and short term deposit is sufficient to fund the company's planned operating plan at least amended 'twenty 'twenty four.
Now I'll turn the call back over to Jonathan for his closing remarks Jonathan.
Thank you Marina My honest is poised to enter 2023 on solid footing with a strong balance sheet and our focused strategy of advancing big stuff below four program.
On a personal note I'd like to close by saying that as a big step below full program has expanded these last several months many of us at bionics I've had the opportunity and privilege to meet with physicians advocacy groups and of course see if patients themselves.
Truly drives home the importance of our ongoing research and development efforts.
While great strides continues to be made and extending survival. We know that much more work needs to be done so that people living with CF can live longer and healthier lives.
Our singular focus will there be extra below four program is to develop a truly groundbreaking therapy. They can achieve this goal.
With that Marina and I would now be happy to take your questions operator.
Okay.
At this time, we'll be conducting a question and answer session. If he would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your lines in the question queue. You May Press Star two if you would like to remove your question from the queue.
First using speaker equipment and may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.
Our first question comes from Joe pension Us with H C. Wainwright. Please proceed with your question.
Jonathan in Marina Thanks for taking the question and thanks for the quick update so.
So first I really wanted to just focus on the CF program for a moment at first if you could define the enrollment enhancing mechanisms that you've been discussing and secondly, as part of that.
What the real World impact has it had been from the holidays.
In September on both the scheduling and analyses.
Hi, Joe and good morning.
Same question I think we have seen the initial enrollment are slower than we anticipated.
Some of it is definitely about the you know the holidays in September you know and but I think mostly as we look into it it's been in the fact that as we talk to other peers and companies have seen slower enrollment rates somehow associated with you know COVID-19 with yeah turnover yellows and some other.
Or general trends I think that we're saying I think that sometimes commented a whole industry. What we've done is obviously work on the interface with the CRO and improve the ways. We interact we've added increased substantially.
It's actually the number of sites as well as some other.
Mechanisms, we put in place internally as well as externally and I think we've been very very encouraged.
But by the uptick that we've seen in the wallet and that's what we're giving the guidance and you see that although we're seeing the delay in part one it doesn't translate to you know dramatic demand to cause I think now we have a good handle.
I'm sort of patient enrollment dynamics and crossing our fingers I think were.
Kind of look at it that way.
Okay I understand thanks for that and then I guess looking forward to the part one data in the first quarter now for the patients that had already been enrolled and have been on study for X amount of time is it possible to get any additional information beyond what you might have been looking for.
You know even with regard to any respiratory impacts beyond microbiological are you still sticking to that.
The original plan for data release.
Are the types of data.
Yeah. So I think you know, we're we're sort of looking at all of the standard parameters I think the part one is really sort of effectively a few days so.
So we're not expecting really improvement of the F&B one.
And again this is Betsy safety safety study. So I think that's what we're looking into like but we'll measure microbiology as well as it can be.
Once of the parameters, but definitely the direction just too short for something like that right I think in part to again still a relatively small study, but here, we're looking for more robust signals in terms of microbiology.
And some of the anecdotal signals on F N b.
So I think that others have demonstrated some sub trends there and I think we'd want to see something there as well.
Got it thanks for the added color Jonathan.
You bet.
Our next question comes from Mike Higgins with Ladenburg Thalmann. Please proceed with your question.
Thanks, everyone. Thanks, Jonathan for taking the questions just to follow up I guess on a couple of floors enrollment pace and so forth where there any amendments that were written or is this just a matter of adding additional sites and a follow up to my own question there would be.
How many sites did you go from two for us. Thanks.
Thanks, Mike and good morning, I'm. So we have not made any significant amendments it's definitely those mechanisms the additional sites and I do think it's important to sort of.
Sort of craft and perfect interaction with their C. O L. A we haven't disclosed publicly what the number of sites awesome can't share that information, but we have added and that's it.
You kind of see the uptick in you know like everything it's finding those sites that can give you more patients and you know a lot depends on personal relationships.
So I think it's it's kind of learning how to work in the post Covid World and again, what we've seen recently is this.
Substantial uptick and I think that's what gives us optimism and you know we're seeing there's just excitement in the field right. There's a few other political studying since yes, there's more data kind of trickle in from phage Ah It's yes.
It's an exciting time for the field and I hope. This excitement is also kind of helping you know recruitment patient awareness et cetera.
Just to follow up on that.
This being a C. F Foundation supported clinical trial I assume those sites are also see us CFS trials, but if you can just confirm for us and if not can you actually go outside of the CF Foundation sites. Thanks.
So we're working hand in hand with the foundation.
They've been a great partner you know their wealth network.
Protocol.
And sort of thinking how to go about and recruit patients you know in terms of patient awareness. So there's definitely a partner.
In this effort and you know there.
It's been dramatic right I think without that the field would have not moved so much. So there definitely are a partner of choice.
Thanks, guys.
Yeah.
Our next question comes from Kristen <unk> with Cantor Fitzgerald. Please proceed with your question.
Hello. This is Eric on for Christian. Thank you for taking our questions could you talk about switching gears to atopic dermatitis could you talk about what specific questions you're asking as you pursue preclinical activities for <unk>, five and a D and what's the gating factors are you looking at before getting into a clinical trial in a D.
So India topic first.
Good morning Valerie.
It would be a topic during program, we're basically working with meru and their expertise and formulation I think we're trying to kind of implement takeaways that we had on topical formulation. So working hand in hand with them to think when you know how and when best to launch the study and again it just bearing in mind you know the corporates luxury that we had a lot of the effort is now onto C. F.
Right once kind of things are heading in the right direction, we'll be able to kind of reassess how to go about it.
Okay, and then maybe just one more thing the press release, you mentioned wrapping up GMP production for Bx double O five how should we be thinking about effects on R&D expenses in the near term keeping this in mind.
So so far it's all been budgeted I cant, let Maria and I kind of give you more flavor.
Okay.
Hi, good morning, so yes in the budget and definitely the runway that we announced takes everything into account, including any GMP manufacturing and any programs that you announced.
Okay. Thank you.
Right.
Yeah.
Yeah.
Yeah.
We have reached the end of our question and answer session I would now like to turn the floor back over to management for concluding comments.
Thank you again for joining us this morning, and we look forward to providing you future updates on our clinical programs in the new year again. This is very exciting times in phage therapy in general and we hope to provide a more in Jamaica and the new year. Thank you all again.
This concludes today's conference. Thank you for your participation you may disconnect your lines at this time.
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