Q1 2022 Mediwound Ltd Earnings Call
Good day and welcome to the <unk> first quarter 2022 financial results and presentation of the S. Correct Phase two clinical trial results conference call.
At this time all participants are in a listen only mode.
Following managements prepared remarks, we will hold a Q&A session.
To ask a question at that time. Please press the star key followed by one on your Touchtone phone.
If anyone has difficulty hearing the conference. Please press star zero for operator assistance at.
At this time I would like to turn the conference over to Monique coffee of lifestyle advisors. Please go ahead.
Thank you operator and welcome everyone.
Earlier today <unk> issued a press release announcing its first quarter 2022 financial results and provided a corporate update.
We will be reviewing those results with the management team. In addition to hearing from two kols on the results of that S. Corrects U S phase II trial, which were announced in a press release issued on May 12 2022.
You may access both releases on the company's website under the investors tab.
With us today from management are Sharon Malka, Chief Executive officer of marijuana.
Oh for Golan Board member and Bullets Girl Levy Chief Financial Officer.
Also joining us are professor Rosenberg, Chief Medical Officer, and Dr side, Doug.
From advance food and ankle.
Center, Las Vegas, and an investigator in the S correct phase two studies.
Before we begin I would like to remind everyone that statements made during this call, including the Q&A session relating to meta once expected future performance future business prospects or future events or plans are forward looking statements as defined under the private Securities Litigation Reform Act of 1995.
Although the company believes that the expectations reflected in such forward looking statements are based upon reasonable assumptions actual outcomes and results are subject to risks and uncertainties and could differ materially from those forecasts due to the impact of many factors beyond the control of metal.
The company assumes no obligation to update or supplement any forward looking statements, whether as a result of new information future events or otherwise.
Participants are directed to cautionary notes set forth in today's press release as well as the risk factors set forth in meta wounds annual report filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward looking statements.
At this time I would like to turn the call over to Sharon Malka, Chief Executive Officer of medical Sharon.
Thank you Monica.
Good morning to our listeners in the U S and good afternoon.
Those joining us for my side.
Welcome to our first quarter 2022 conference call to discuss our financial and operational highlights.
Yeah, we're very pleased to have two esteemed key opinion leaders with us on the call today, well first of all Neil wasn't bad Chief Medical Officer will somebody want and ductile side the principal.
Principal investigators in both our phase two study and the pharmacology study on the advanced wound and anchor center in Las Vegas.
They would share that insight when I was asked to kind of dial in desktop and also provide some perspective on the overall won't get boxes.
After all of that discussion we will here a quick review of the financial form bought before opening the call for Q&A.
First let me provide the quick in view of our quarter and recent updates before taking a deeper dive with a K O N into the clinical data the way it got it.
Starting with that correct.
Excited to report positive data from the U S phase two clinical study of <unk> that's correct.
<unk> of venous leg ulcer.
The study met its primary and key secondary endpoint with statistically significant results.
Prior to the control arm.
That is demonstrated significant improvement, although the current standard of care.
And no observed on the theory that effect.
On wound closure and no safety issues.
Yeah.
We highlighted some of these without the SA WC spring 2022 symposium in April and received a very warm welcome and heightened interest by the stopped wound care, especially from around the globe.
They didn't do it was very encouraging and.
And we were very pleased to have received recognition for sale, which was selected as one of the top 10 posters out of that 275 Fausto.
Calling from.
And all of a Nexobrid program, we continue to partner with Baba and so everything for the approval of Nexobrid and look forward to bringing these innovative products to the U S market.
We remain on track for immediate Resubmission of the Nexobrid BLA and we anticipate six months if you bought it.
Position Nexobrid for a potential approval by easing and a commercial launch in the U S. In the first half of 'twenty to 'twenty three.
To that end buyback spend it is contract providing guests with supplemental funding of $9 million.
Support the Nexobrid BLA Resubmission and don't go into expanded access protocol, which will run through approval.
Lastly on Nexobrid.
I'm proud to have started the project with the U S Department of defense for the development of Nexobrid for the U S Army at the Nonsurgical solution for critical bands treatment.
These research for the project if successful could open the gate for armies all over the world.
As well as simplify our supply chain cost and administration.
Let me now for fighting weaken if U S.
That's got a phase two study design and the Qt thoughts before handling the call to all of those things Kols.
The study was a multicenter prospective randomized placebo controlled adaptive design study.
I think the safety and efficacy of SK and debridement of real use.
Compared to gel vehicle.
A placebo control and compare to the nonsurgical standard of care of either in thematic autolytic debridement.
The study enrolled 120 patients with 119 treated at approximately 20 clinical sites, primarily in the United States.
Daddy participants.
Bye I did ask Alex 46 patients.
Vehicle forty-three debating all nonsurgical standard of care and another 30 patients.
The three months follow up.
The single primary endpoint was incidence of complete debridement clinically assessed within up to eight.
Occasion doing an assessment period of.
All 14 days compared to the gel vehicle placebo control as agreed with the FDA.
Secondary and exploratory endpoints I said time to achieve complete debridement.
Pain reduction of wound area, granulation tissue and quality of life, enabling evaluation of clinical benefit compared to both jetblue.
And the standard of care.
Incidence and time to achieve wound closure will assess a safety measurement.
Turning now to the study results.
The study met its primary endpoint with a high degree of statistically significant.
Demonstrating that patients treated with SK had a statistically significant higher incidence of complete debridement compared with the gel vehicle.
Most of us typically.
63% of the patients we did we got 93 patients out of 46.
Cheap complete debridement by eight sweetman.
And this compares with only 30% of the patients we tend to be the hydrogel vehicle.
Which is about 13 patients out of 40 Creek.
With a P value of steel upon seals the awful.
That's correct efficacy.
D remained statistically significant compared to the jet vehicles also after adjusting for Prespecified COBOL, yet, it's got two patient baseline characteristics wound size.
<unk> age and reagents.
The study also met its key secondary and exploratory endpoints that provides further insight on additional efficacy by myself and can establish clinical benefit.
Starting with head to head comparison, we then nonsurgical standard of care.
Adding enzymatic debridement autolytic debridement.
63 of the patients treated with <unk> achieved complete department compared to only 13% of patients with it we signed up a scale.
All patients out of 30 patients within the 14 days assessment beautiful.
And the time to achieve complete debridement was significantly sholto.
The estimated median time to complete debridement was nine days for patients with acute aesthetics compared to 59 days for patients treated with the nonsurgical standard of care with a P value of 0.01.
Yeah.
Moreover, one average completely Bradman was achieved after less than full applications with aesthetic compared to almost 13 applications with a nonsurgical standard of care.
These significant improvement over the current standard of care is important when you consider that the non sharp debridement agents and thematic of ideal currently available in the U S market.
<unk> daily application for several weeks to achieve completely blind men, yet still generate hundreds of millions of dollars every year.
Patients treated with aesthetic.
Demonstrated significantly higher incidence of at least 75% granulation tissue at the end of the treatment period compared to the gel vehicle with P values lower than 0.001.
Which is required for wound healing.
And finally.
Favorable trend will upset in wound area reduction and reduction of pain compared to gel vehicles.
They're both efficacy results achieved our key goals in this study one to demonstrate the efficacy and the bride meant chronic wounds.
Two to establish a clear improvement over the current standard of care and three to give us a clear guidance for future studies.
Studies in the indication of our interest.
In addition.
The study showed that <unk> was safe and well tolerated and the overall safety was comparable between all.
Importantly, there were no observed.
Nick on wound closure and no material differences in reported adverse events.
Actually the estimated time to complete wound closure was 64 days for patients treated with <unk> correct.
Fair to 78 days for patients treated with standard of care.
With that we achieved additional goal for this phase two study, which was to assess the safety and Tolerability and show that is well tolerated treatment for debridement of chronic wounds.
Mhm.
Let me now turn the call over to Professor Rosenberg, our Chief Medical Officer.
To provide us with some color regarding the unmet need there all of the bribe me in wound management, the robust clinical evidence generated to date and how a product like S. Correct.
Right.
The current treatment paradigm.
Okay. So it wasn't bad place.
Thank you very much Jerome and good morning, everybody.
First I would like to thank our partners investigating oh, and especially the <unk>.
Patients and their families for their commitment and perseverance you.
Completing the study.
So all the challenges posted by the COVID-19 pandemic.
Let me start with a brief overview of the debridement drone, it's a critical component of the wound management.
Officials debridement is an essential step in the acute and chronic wound management.
The broadband is embolden, you removing nonviable tissue from chronic wounds.
The granulation tissue and liquid tumor mutation.
The underlying pathogenic abnormalities in chronic wounds cool it could build.
Oh aquatic tissue and regular debridement is necessary to reduce the necrotic burden any cheap empty granulation tissue.
The broaden it also reduces.
Contamination is therefore.
In reducing tissue destruction.
Did spaces did me otherwise harbor material growth must be exposed during the broadband.
Routine care of non healing wounds.
All right.
The necessity to use dysfunction the process.
Uh huh.
Fundamentals of the broadband.
Selected amongst them.
Our babies.
Your school seats.
Advantages and limitations there.
Choice of the Brodman techniques is highly dependent on the site of care.
So to speak.
Patients.
Sharp debridement is the dominant debridement missile use.
Non sharp debridement techniques, mainly two reasons.
It might be the broadband.
Primarily use a job too.
Sure.
Sure.
<unk> considered.
Sure.
There was a great unmet need to effectively.
The bride Chronicle in an easy to use nonsurgical and prompt manner to enable.
Moving to the risk or a clinical evidence.
Continue to be impressed by the compelling clinical data generated to date U S clinical trials.
In the first phase two randomized controlled study.
That's correct.
Secrecy.
Civil issue languages.
<unk> you.
Diabetic foot ulcer and view leg ulcer and posttraumatic.
Patients treated with <unk>.
Craig This is significantly higher incidence of complete debridement.
Patients treated drove it.
That's great.
This is Joe.
Person.
The P value.
Hmm.
Susan.
And complete debridement was achieved earlier in patients treated with <unk>.
Yeah.
The effect was even greater in the door.
The extra ounces.
We will.
And it's safe and well tolerated in all this is.
Doses and dosing regimen.
The robust results across multiple endpoints in the U S phase two randomized controlled studies for the debridement of view corroborated the results from the first phase two study and demonstrated.
Things should significant clinical and patient beneficial impact.
Correct me.
Right.
That's correct demonstrated significant incidents.
Complete Debridement Museum.
E applications.
For both.
Very good and nonsurgical standard of care.
To achieve complete debridement was significantly shorter compared to the control arm was significantly lower number of daily applications.
In addition, <unk> demonstrated higher incidence.
At least 75% granulation tissue who's the driving which is critical to bid preparation work.
Fueling with no deleterious effect on wound.
Got it.
Lastly data from our ongoing phase II pharmacology study.
That's correct demonstrated safe and effective debridement.
Sure.
So both diabetes.
Awesome.
With few daily application.
It's going to demonstrate significant debridement.
During the treatment period.
Everett.
84, nonviable tissue persist nonviable tissue removed and significant decrease in size by the end of the two week follow up.
In addition.
In the valuation of the tissue samples.
For Wilsons images.
A reduction by two.
<unk> reduced from 244 at baseline coupon seven well.
Treatment and Victor load following treatment with.
That's correct rib Wilson's disease.
From 172.
Balan baseline two seven.
After the brightness.
The product is correct.
Into the unmet need for.
An effective non surgical debridement.
For 'twenty one.
Yeah.
It is an easy to use daily topical Jim.
Yes.
In the study significantly improve the rate of complete debridement.
The patients thus facilitating wound debridement.
I believe that this group holds great potential to be a significant contributor in this market.
And welcome additions to our amendment volume.
Chronic wound care.
Let me turn the call.
Over to Doctor can you be dull who treated more than 10 patients <unk> print.
Principal investigator in both countries.
Two studies.
To share her clinical experience with this group.
And how the product like wood.
Within the current management practices.
Hello.
Thank you Doctor and good morning, everyone. It's my pleasure and privilege to joining this call and share my hands on experience with Eschar acts. My name is Doctor Cindie Dev and I am the owner and Chief Medical Officer at advanced wound and call Center in Las Vegas.
Nevada for the past 16 years.
And our clinical practice, we deal with chronic non healing wounds on a daily basis says a chronic wound as we all know is the golar trading both physically and physiologically. It also serves as a point of entry for local and systemic infections is a huge financial bar.
Then patients caregivers caregivers and society.
Does that is that we're talking about today is very positive and encouraging and a disease, where we really have very few treatment options that are effective and really work.
Despite the growing number of new and innovative products on the market.
Why does the treatment of chronic wounds still continues to be such a great problem.
For non healing wound products to work you initially have to have a wound that is clean and physiologically ready for these products.
Active debridement is a critical first step per room that preparation in order to facilitate effective wound management.
As described by the Doctor previously the most commonly used non surgical debridement methods include enzymes, we have hydrogel and other topical dressing which require quite a long time to achieve that.
If they achieve this at all.
I've had the privilege of treating several patients suffering from either venous leg ulcers or diabetic foot ulcers with eschar apps and my experience. After several applications of eschar ex usually two to six application. What we'll find is that the wounds has a very vibrant.
Healthy robust and uniform granulation tissue granulation tissue that is ready to move on to negative pressure therapy or cellular therapy or even closed secondarily.
The level of debridement achieved by eschar axis, very precise and not something that I didn't replicate with traditional debride mountain methods, especially sharp debridement, which is typical.
That is why reinforces my belief that eschar X is precise.
And not I'm, sorry that is why it enforces my belief the eschar X has the potential to become a best in class topical debridement products for the treatment of chronic wounds.
We encourage you might be willing to move forward with its continued clinical development and I look forward to the data Ashqar X becomes available.
I really appreciate the opportunity to speak to all of you today and now I will turn things back to Sharon. Thank you.
Thank you very much Dr. Dov and thank you Doctor Oz Inbev Youll.
Your insights on this call the great need for a product that can effectively deep right chronic wounds in a nonsurgical effective and prompt manner.
Chronic wounds it presented significant burden to patients health care professionals and the health care system.
They affect millions of patients and the cost of treatment plans into billions of dollars annually.
Like started to bring the Sci clinical development plan for awards, given the magnitude of it commercial opportunity.
Germany.
The bride man is a critical component of wound care. There are about 2 million patients with venous leg ulcer and they are critical to us is that undergo debridement every year in the U S alone.
The two most commonly used non surgical debridement metals and thematic autolytic general several hundreds of million in says every ive yet can take weeks to show effect, leaving much room for improvement.
We that's correct on the other hand.
We've shown to be safe and effective and deployment of how to in wounds. We gave few daily application.
Looking now to our plans for development.
We believe the data from this study and the clinical evidence generated today.
<unk> father insight on that additional efficacy Parramatta and can establish clinical benefit.
This enable us to better design the pivotal studies.
We plan to file that clinical data with the FDA and to request an end of phase two meeting in the second half of 2022.
Our goal is to work with the FDA on establishing a claim for a potential phase III pivotal plan for SK as soon as possible.
S. Correct clearly has the potential to become a game changing therapy, and we are committed to bringing it to the market.
We believe SK <unk>.
Ill positioned to potentially become a best in class debridement option for millions of patients suffering from house will want and transforming.
<unk> management.
Before turning the call over to Bob for assignment of a firewall financial I want to address the news announced today of <unk>.
My transition to the bolt and the appointment of ortho gone in as the CEO .
I have accomplished my goal as CEO of positioning the company for long term success and strong future.
<unk> is on the cusp of a very exciting chapter of the company's pipeline portfolio is in a strong position for continued advancement, including market expansion for a successful commercial product nexobrid.
Potential near term launch in the U S for this product.
And the promising best in class therapy for wound care.
It has been in horn ought to lead this company and the entire team at <unk>.
And I look forward to supporting offered in my new role as a member of the board of directors and helping the company realize the tremendous opportunities that lie ahead.
Ofer brings more than 20 years of experience in managing life science investment in global businesses.
He has extensive managerial experience in leading companies.
Global network and deep understanding of maiden once rents and potential position him uniquely to lead <unk> next phase of success.
I will continue supporting the company as a board member and showing success with our BLA pasta and reinforcing our strategic alliances and collaborations.
We are positioned for success.
And paused for our transformational year.
Now, let me turn the call to all fell asleep.
Thank you.
Good morning, everyone.
I'm honored and excited to assume the role of chief.
Uh huh.
Thanks to the strong foundation built.
Hi, Sean and his team.
We experienced an ongoing support.
Restaurants, maybe.
Maybe one has tremendous potential.
Global Biopharmaceutical company.
I look forward to driving the next phase of them anymore.
Continue to advance.
Program.
Patient access to our technologies and <unk>.
Kris.
Oh sure.
Let me turn the call back to Sean.
Thank you all fail.
Now, let me turn the call to Bob for a brief look at our financial.
Thank you, Sean and good morning, everyone.
Everybody have started what we believe to be an eventful year.
Recently right.
Isn't it.
These funds.
Along with our Nexobrid commercialization efforts and the expected.
Coming BLA approval provide us with a solid balance sheet to meet the upcoming milestones and activities throughout the next 24 months.
Let me now review the financial statements over the quarter.
Total revenues for the first quarter 2022 was $4 4 million compared to $5 8 million for the same period last year.
The previous quarter on a comparable basis.
Mainly related to product revenues due to the decreasing partners emergency stockpile recruitment.
$1 2 million.
Gross profit was $1 5 million.
First margin of 33%.
Turning to gross profit of $2 4 million and gross margin of 41% for the same period last year.
Operating loss was $3 3 million compared with one 9 million in the fourth quarter of 2021.
This resulted primarily from a decrease in product revenues to BARDA.
Net loss was $3 6 million or 12 cents per share compared to a net loss of $2 9 million or 10 cents per share for the first quarter of 'twenty to 'twenty one.
Adjusted EBITDA was a loss of $2 6 million compared to a loss of one 3 million for the first quarter last year.
Moving to our balance sheet highlights.
As of March 31, 2022, cash and short term investments were $16 8 million.
We remained on budget.
<unk> 4 million from the fourth quarter of 2022 cooperation on excuse me.
Again, our cash position is expected to be sufficient to support the anticipated operating activities for the next 24 months.
For the full year of 2022 we expect cash used to be in the range of 11 to 13 million.
With that.
Through the financial overview.
I'll now turn the call back over to Sean.
Thank you Budd.
I'd like to thank the investigators and Kols and patients who participated in this study and especially to think well first of all was in back in ductile <unk> for joining us this morning.
Naturally we are grateful for their participation in our study and for giving US the time this morning.
But we also appreciate the ability to view the clinical data and place it into a context of ultimate objective, which is helping patients in real world clinical practice.
So thank you.
In closing we are.
Very well positioned.
We are on track to resubmit, our Nexobrid BLA by mid year and continue to anticipate approval by the end of the year.
We are preparing to meet that with the F. D. A in the second half of D C to discuss SK and gain clarity on path towards approval.
And we are welcoming offer going in to take the company to the next level of success.
I look forward to continuing to support the company as a board member and I'm certain we will enjoy a smooth transition.
With that I would like to turn the call to the operator to open the lines for questions operator.
If you'd like to ask a question at this time. Please press. The Star then the number one key on your Touchtone telephone.
To withdraw your question press the pound key.
Again that is star then one if you'd like to ask a question.
Our first question comes from Josh Jennings with Cowen.
Hi, This is Brian here for Josh. Thank you for taking my questions.
I want to ask about the comment in today's press release about realizing the potential of your assets can you address your interest in looking for a partnership for either eschar Axert nexobrid outside the U S and I guess, maybe more plainly given the strength of the phase two data we've seen for eschar ask what's your commitment to.
Two independently completing the phase three program.
Good morning, Goodbye and thank you for the question.
So as communicated previously I think that now we are even better position for the next stage in terms of flexibility.
The financial injection of the cash injection, we had in the first quarter to strengthen our cash position now we have additional clinical data very robust clinical data, providing us with the ability to establish a improvement over all current nonsurgical stand.
Of course, this provide us to explore all alternatives, which are taking the product to the finish line, but I will sell while exploring any idea on potential collaborations.
Premature now to discuss that tentative, but I can show you as you've really if Remy we have now the opportunity to explore all options, giving them a path that we have on hand. Thank.
Thank you.
Okay. Thanks for that and I guess on the Nexobrid BLA, you've outlined the timeline to approval that matches, what you'd face in a typical class two resubmission. So my question is has the F. D. A definitively indicated that this is a class two resubmission and if so can you.
Discuss where you stand with factors such as the inspections and your readiness for a potential AD comm panel if that's requested.
Thanks.
Again, we remain on track for that meet theory submission for the Nexobrid BLA and we anticipate that six months a few process. The six months of your processes by law, usually takes either two to six months.
But given the COVID-19 and the backlog FDA has since the Covid, we know that it will take six months of review and which position nexobrid for the potential approval by year end and commercial launch in the beginning of 2023 in the first half of 2023.
We can't speak on behalf of the F D a.
I think the ability to get full pre approval inspection in our facilities that being said, we have been aware that the F. D. A.
A inspected facilities outside the U S. Both in Europe , and Israel and when college by that looking forward to get the FDA response, why we submit the F D. A.
As you know.
We didn't set demands form a resubmission, we will get the F. D. A we expect to get the FDA acceptance and timeline for that if you at where last fall day potentially prevent infection.
Thanks.
Okay. Thank you.
Our next question comes from Kevin <unk> with Oppenheimer.
Hey, Thanks for taking our questions and our first time on a yeah. Thanks, Sharon for problems, helping feedback for several years and all of our questions.
Don't know where the Doctor does here for Q&A.
You know I guess were primarily interested in better understanding.
How nonsurgical enterprise <unk> is used in <unk> patients, who they have specifically circumstances under which to choose as a standalone versus you know an adjunct to sharp debridement.
Sure. Thank you very much for the quest.
Question Kevin.
Hugh I can share with the audience that you are joining me in the last assay WC. The last conference and we did see that's usually the nonsurgical meaningful that Brian mentioned using conjunction with shop at the maintenance debridement, but this is what we know about the market.
And let's liver tox that doctor, David available and for Baidu would help us like people have experience. So doctor that can help you with that point.
Yes, I can.
So with the Eschar acts clinically I did not when we applied and as per the parameters of the trial. This was applied and there was no I shouldn't say, a sharp device and even in patients who had barely deep wounds for diabetic foot ulcers traditionally.
And my private practice it is some type of enzymatic debridement, but almost always in conjunction with the sharp debridement.
So you said the Eschar X again to reiterate was very precise much more precise than what I can replicate them via traditional sharp debridement with the 15 blade in my office.
I hope that gives some clarification to you.
Thank you.
And maybe building on that I mean based on the phase III data.
And I guess this is for private company of our Doctor jobs together.
Do you envision an evolution of standard of care potentially wear.
That's correct replaces the non surgical debridement, but you know where most patients continue.
To get surgical debridement.
And thus you know the.
The non surgical in central Asia, and a drunk.
Process or do you anticipate or envision.
Essentially a reduction in the volume with sharp debridement and more.
Stand alone non surgical.
Illinois to arrive in the decade.
Thank you for that Kevin.
I will start to provide you what we know about this and what to expect in Denver, So that can add to it.
Their perspective.
Given the feedback that we have which comprise of a sale market research we conducted in the U S and in Europe and given the feedback we get just in the last conference in the U S. S. AWP, we believe that even the efficacy.
S K, providing an effective and grumped deep right now.
But then at the bank the wound bed for the next stage of feeling we believe SK can be positioned as a first line therapy staking not play not only replacing the cabin and thematic stand of care, but rather take on silk Chang for them there.
Politics, as well up on the shelf.
I've met and this is exactly what the market research indicated and what's your growth as a feedback.
It's in the best benchmark for that thing to the one to ask.
That taught them is still in the wound care industry.
The buffet and a way out.
And I by no way I was a mixture for Atlantic and damaged product bypass phone that was dominant in the market and use as a first line therapy, because it was effective and when I say effective.
He prided wound in about two to three week you are talking now based on the clinical background product that's been provided with dicey.
He will be driving less than full application.
Got it.
A full application.
And with that I would like to turn the call to <unk>.
Sure.
<unk> and <unk>.
Look this up.
Yes, so as a principal investigator in the trial and as a physician who sees private practice patients.
I think that there is nothing on the market like this product.
Does it is standalone without surgical debridement because of the speed and precision of Eschar X I.
Think that this will become standard of care therapy on the market and I think that for the large wound care centers and private practice physicians. This will be the first line therapy.
Because it was incredibly effective at your breathing and incredibly fast as well for the patients who are treated out like that so yes. This will become in my opinion it will become the standard of care first line therapy.
Thanks for taking our questions.
Thank you Kevin.
As a reminder, if you'd like to ask a question at this time that's star then one.
Our next question comes from Arthur He with H C Wainwright.
Hey, good morning, everyone are these the author in guar Kate Thanks for taking my question and congratulations on the robust data from the Phase two study. So my first question is for the doctors. So within these are the secondary and exploratory end points.
The phase III study.
Which one is more in your view as being important in terms of the medical perspective.
Thank you. Thank you for your question and thank you for the question also.
I will turn the call to Paul first of all I'd like to share. His do you intend to pay for it to dovetail off the shelf have you regarding what is the meaningful of the secondary endpoints in terms of wound bed preparation.
So it wasn't like.
The Corporation is really the first stage and the necessary steps for wound healing.
And what we found.
Equals the granulation tissue who's much more abundant and much more.
Should we see kicking in living than what we saw in the standard of care.
The meaning of having such a good relation tissue.
He is the one Kim.
Really either he'll do we buy.
Grasp thinking and this is an immediate closure or hearing your bikes continues if utilization who take a bit longer but the utilization tissue means that the wound bed is alive.
And the model for wound care is what we call time.
For tissue inflammation et cetera et cetera.
This means.
We really kind of.
Having the key to open.
The wound care too much faster and much more efficient way.
Yeah.
Treating you.
Thank you the profit dollars and back book, So Doug can you provide your colo.
Yes, you know I wouldn't really builds on my Doctor Rosenberg said, if you do not have a three well pad with a healthy granulation tissue that is robust you have nothing because we'll never proceed past that inflammatory stage you will never have a decrease in size you will not have the decree.
And pain, you'll never habits and improvement in quality of life you have to have that initial healthy wound bed before you can even contemplate moving onto it means a closure so in my perspective.
Primary endpoint are healthy.
Complete debridement getting in getting their healthy wound bed is the most vital endpoint that we have.
Thank you very much that filled up.
Oh. Thank you. Thank you very much for both and a.
Follow up on the Florida for sure I and the team.
So guess.
Based on these robust data from the phase II study.
Could you guys give us more commentary on the potential pivotal study design and.
The potential costs related to that.
Thank you yeah.
Thank you for your question so as I said before first of all it's premature yet to provide a clear that on the next stage of development in terms of size.
10 of the study number of studies et cetera, given the fact that we did not yet.
Coffee the F D a.
Back to continue analyze that data as you know we provide a robust data set but we will continue to analyze the doctor population in order to establish additional benefit.
S correct comfort to both gel vehicle and a.
The standard of care. We also expect final data from the ongoing phase II Pharmacology studies, which is conducted with failure the issue where they initiate that demonstrated in addition to our paid debridement also reduction in biofilm and microbial load. So we want to get them. All this information integrated.
That form the first phase two study from Europe and Israel.
<unk> phase two study from the U S and the pharmacology phase two study integrated data establish a plane.
The next stage and shared with the FDA once we'll get the F. D. A once you have more clarity on that closely communicate a DC plan we'd agree. Thank you.
Oh. Thank you. Thank you very much for the additional color. Thanks for taking my question.
I'm showing no further questions in queue at this time I'd like to turn the call back to Sharon Malka for closing remarks.
Yeah.
Thank you very much.
We look forward to updating you again on our next earning call and have a great day. Thank you.
This concludes today's conference call. Thank you for participating you may now disconnect.
Thank you.
Okay.
Okay.
Okay.
Yes.
[music].
Okay.
Okay.
Yeah.
Okay.
Okay.
Yeah.
Okay.
Hum.
Hum.
Thank you.
Yes.
Okay.
Hum.
Okay.
Yes.
Okay.
Okay.
Yes.
[music].
Sure.
Sure.
Yes.
Hum.
Okay.
Hum.