Q2 2021 PolyPid Ltd Earnings Call
[music].
Greetings and welcome to the Poly pet second quarter 2021 conference call.
At this time, all participants and.
And he married ASIC.
As a reminder, this call is recorded I would now I'd like to introduce your host for todays conference. Mr. Bob You did some lifestyle advisor says Mr. He did you may begin.
Thank you all for participating and Poly peak second quarter 2021 earnings conference call.
Joining me on the call today will be a mere weisberg, Chief Executive Officer, and <unk> chart, because OXXO broad executive Vice President and Chief Financial Officer.
Earlier today <unk> released financial results for the three and six months ended June 32020, while copper.
A copy of the press release is available on the investors section of the company's website www Dot <unk> dot com.
Like to remind you that on this call management will make forward looking statements within the meaning of the federal Securities Laws. For example management is making forward looking statements.
And when it discusses the expected recruitment of trials timing of trials and release.
The results thereof, and capacity of the company's manufacturing facility the company's pipeline.
Potential benefits for flex and <unk>.
The companys potential partners and sufficiency of cash to fund future operations.
Forward looking statements are subject to numerous risks and uncertainties.
Many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings.
Our results may differ materially from those projections.
These statements involve material risks and uncertainties can cause actual results or events to materially differ.
And Lake you should not place undue reliance on these statements.
I encourage you to review the company's filings with Securities and Exchange Commission, including without limitation, the company's forms 20-F, and 6K, which identifies.
Specific factors that may cause actual results or events to differ materially from those described and its forward looking statements.
<unk> disclaims any intention or obligation expect.
As required by law to update or revise any financial projections for forward looking statements, whether because of new information future events or otherwise. This conference call contains time sensitive information and speaks only as of the wide broadcast today August 11.2021.
And with the completion of those prepared remarks, it's my pleasure to turn the call over to EMEA Weisberg CEO Amir.
Yeah.
Thank you for both.
On behalf of the product and team.
I would like to welcome everyone to our second quarter 2021 earnings call.
I will begin today with some brief introductory comments and then decline.
By the day.
And the review of our financial results.
We will open the call for your questions.
We have recently achieved significant progress in advancing our.
Many development programs and continuing our progress towards becoming a commercial company.
As you know we are currently in a large phase III program with our lead asset <unk> flex one hunting for the prevention of surgical site infections or exercise.
Ssi accounts for about 20% of all hospital acquired infections and the U S, resulting in extended hospital stays and.
And re admissions and adding up to $10 billion and annual medical costs.
I will provide further details on this program shortly and <unk>.
Cited to report today.
Our ongoing share one time and abdominal surgery continues to proceed as planned and we are succeeding in accelerating enrollment into this study.
Importantly, following the type B meeting request to the FDA and the second quarter. We received a written response from the agency regarding our development plan for this ex 100 day.
<unk> indicated that provide our results are adequate our proposal for a single phase III pivotal study should one please.
<unk> and thus evidence of the clinical efficacy and safety to support approval of <unk> 100 for the prevention of Ssi and colorectal surgery.
We are very happy that our proposed development plan for the potential approval of <unk> 100 has been accepted this will reduce the anticipated cost for the program and provides us with additional financial flexibility overhaul.
<unk> two our second phase III trial, and abdominal surgery offer broader eligibility criteria, including minimally invasive surgical procedure. These.
And this trial is also advancing as expected with new sites continuing to open on an ongoing basis.
Im also pleased to report that our promising Hong Kong clicks development platform and oncology continues to progress quickly.
With this and I am.
Excited to announce today that our initial target indication for <unk>.
We'll be brain tumors.
Local delivery can be a game changer and cloud will provide further details on the shuttles and planned next step for on complex. Shortly and you can see fully business recently achieved important progress throughout our business.
We also continue to be supported by a strong balance sheet, which we expect to be sufficient to complete that issued one study to conduct two and prepare for the submission of and to the FDA as well as further advanced our non complex development platform.
I will now turn the call over to <expletive> to provide you with some further updates on our other businesses.
Now please take it from here.
Thank you Amanda and thank you all again for joining us on the call and I will.
I'd like to begin with a brief discussion on the status of our pipeline.
The pace of enrollment in the shield one trial has been strong to date.
And to continue to accelerate.
We now have over 300 patients enrolled into the study and based on the current environment. We believe that daily Cookman trade will continue to gain momentum and demand to come.
Approximately 70% of the patients currently enrolled in shield, one has a colorectal cancer diagnostics and rates.
Similar to the 74% C successfully completed phase two trial.
Importantly, the high priority and nature of the surgical procedure and makes them less influenced by the ongoing COVID-19 pandemic worldwide.
Other reasons for colorectal surgery and include mainly Crohn's disease, and inflammatory bowel disease and it was also seen and all completed phase two of them.
Okay, and the data safety monitoring committee and share.
And with the review of accumulating safety data and study conduct for the shield one study.
And why its recommended to continue the study without modification, meaning that no major safety issues related to deep debt 100, and being looked at and shield one to date.
And as a reminder, our plan is to enroll 616, two 900 patient within 60 centers and the U S EU and Israel.
One 500 patients have completed the first months follow up and have been evaluated for the primary endpoint and.
The study design provides for the blinded sample size re estimation based on the overall infection rate observed in the study.
Only the low end up for around 650 patients planned to be enrolled is necessary, we continue to anticipate variability.
Top line data from the shield, one and the end of seafood.
Moving on and something.
And you indicated while on the positive results from share why non needed for FDA approval. We continue to move forward with shield, which has brought to is it your ability to react and showed one including minimally invasive surgical procedure.
Q2 also continues to progress as planned and although our focus here remains on opening centers. We are pleased with the current rate of enrollment in this study as well.
Total enrolled patients in shield, one and shield to collectively is now approaching 400 patients.
Moreover, we have recruited in just the last year during the pandemic approximately the same number of patients.
And rolled into all five prior clinical trials conducted by the company sees and Corporation.
Now I'd like to further elaborate on the stack and cell phone conflicts of interest.
Intra tumoral chemotherapy product candidate for solid tumors, including tumors with a cumulative uptick resistant.
And as a reminder, on complex provide local prolong and control exposure to those set except.
One of the most widely used chemotherapy agent and.
And the intraoperative tumor resection and safety.
Control and prolonged release of closer to kill and the residual tumor sites may is a critical impact on the prevention of local tumor reoccurring and the potential trading off campus.
And ultimately improve the overall survival rate of cancer patients.
You will recall that we generated compelling data and <unk>.
Animals that we are excited about and different solid tumor indications.
In addition, we expect on complex to significantly reduce the non toxic systemic exposure to chemotherapy one of the important attributes of successful local delivery and cancer therapy and.
And our various animal models to day has indeed shown and very promising safety profile versus systemic came with it.
And as I noted earlier, we are disclosing today that brain tumor has been selected as the initial indication for the uncle Plex intra Tumoral therapy program.
And is currently almost no meaningful treatment option for grain shipments primarily due to the limited ability of existing approaches.
Penetrate the blood brain barrier.
And due to the localized nature of a phone call to make we believe it is highly beneficial and.
Compared to systemic treatment and <unk>.
And specific indication and it.
Addition, its ability to produce the control for Liberty are progressing drug generating a high local concentration of the week.
My father, and hence uncle picks and significant potential in.
Importantly, we expect definitely ability of traditional on complex preclinical data and St.
Schumer shortly.
We believe these result will further support our work toward the completion of our preclinical package for that.
Finding of a pre I and D request with USDA and the coming months to potentially initiate a phase one clinical trial next year.
We also continued spend on network top experts and kols around our own Capex development program to support our efforts and this promising area.
We firmly believe that aren't complex has the potential to become part of the standup of Kim in for.
The tumor resection surgical setting within multiple solid cancer types.
Going back to keep the ex 100 and from a commercial perspective, we have developed a launch plan debt details all of the activities that will occur from now until launch.
Various functions like policies, including sales marketing market access and medical and in addition, and.
Resource plan has been developed to assess their hiring needs and timing for each of the different function as well as the infrastructure that will be needed and.
Preparation for launch.
We are currently in discussions with a number of launch excellent service provider.
And for the commercial loans.
In parallel we also remain in discussions with multiple large and mid sized strategic partners, all with significant presence and experience selling and hospital and.
Waiting room.
Potential collaboration and.
Europe and Asia.
In the U S. We are in contact with several large and midsize pharmaceutical and medical service company, which we believe would be ideal commercial partner for duplex 100.
These companies are leaders in commercializing surgical products and medical devices.
Long established commercial infrastructure demonstrate.
Detailed understanding.
They become and far more economic benefits in the hospital channel and maintained strong relationships with the hospitals clinical and.
And he can and administrative and stuff.
We are progressing with these companies and are quite pleased with the high level of interest and duplex 100.
Before I move on to our recent financial results I'd like to take a moment to discuss the recent registration statement, we filed with the FCC.
And as it is an important strategic element related to the development of our pipeline.
This shelf filing provides us with critical leverage around a commercial partnership discussion.
We have which are recurring and these companies are much larger sized and for you Pete.
Moreover, this shelf filings allows for.
Further flexibility regarding the structure for potential partnership agreement.
Well, we have no immediate plans to utilize this shelf filing we believe it to be a prudent financial tool to have in place.
Okay.
Finally, I'd like to welcome Dr. Anthony Jason and it goes to policy.
For Senegal will serve as senior medical director and will be responsible for developing medical infrastructure, Indeed, and I could see and will contribute to the company's NDA submission and commercial launch of T. Plus 100 Doctor Senegal is a colorectal surgeon with a long track record.
Okay, Debbie surgery proxy and has significant experience and health co startup company.
His background and think surgeon and biopharmaceutical innovator as well as easy unique understanding of the budgeting process and hospital systems will prove invaluable for pursuit.
Two of reducing the clinical and financial burden of exercise.
With that I will now review our recent financial results.
Let's begin with policies balance sheet information as of June 32021, the company had cash cash equivalents short term deposit and loan and deposit.
$52.9 million as compared to $66.6 million and as of December 31st 2020 cash used in operations for the three months ended June 32021 totaled 8 million total.
We expect that our current cash runway will extend into the second half of 2020 two and remain confident that this strong balance sheet will allow us to complete our first phase III trial shield, one and abdominal soft tissue infection to preparing for the submission of an NDA for <unk>.
100, and father and advance our own complex programs towards phase one trial.
Now, let's turn to our income statement research and development expenses for the three months ended June 32021 seven.
Seven pull for $4 million compared to $4.3 million taller and the same three months period of 2000 and tweaking.
And being increased due to the ongoing shield, one and shield two phase III clinical trials and abdominal surgery.
Kitting and business development expenses for the second quarters for 2021 for $700000 compared to $300000 for the same period of 2020 <unk>.
These expenses increased primarily due to an increase in marketing and business development personnel in our offices in new Jersey, and and increasing the market Casey and activity.
We continue to build our commercial infrastructure.
General and administrative expense for the second quarter of 2021 with $2.4 million compared to $2.6 million and the prior year period. The decrease in general and administrative expenses was due to lower noncash share based compensation expenses for.
And the second quarter of 2021 to come to and he had a net loss attributable to ordinary share of $10.5 million as compared to $19.1 million and the prior year period.
We will now open the call to your question operator.
Thank you.
As a reminder, ladies and gentlemen, if you wish to ask a question Dom and fun.
And your telephone keypad and wait for name to be announced.
Your first question today comes from the line of Brandon Folkes from Cantor Fitzgerald.
Alright, Thanks for taking my questions and congratulations on all the progress and.
And maybe just firstly on the potential for label expansion.
And in your discussions with the FDA have they given any color in terms of whether this is going to have to be a sort of indication by indication label expansion or theres potential.
Yeah, maybe for shield two to drive broad label expansion.
And then secondly, and.
And maybe just as you go forward do you intend to focus.
On Q2, and conquer sick any color and prioritization, there or should we expect that day will both continue as is.
Thank you.
Thank you Brandon and it's good to have you on this call.
With regards to label expansion and it is clear to us for more discussions with the SBA debt.
And just going to be indication by indication.
Quite different and that already for a lot of discussions with regarding.
General abdominal and of the.
Colin.
And it's clear that day something that.
And could be done.
And in some of our correspondence and also Q I D. P. We got a broader abdominal general abdominal indication.
Colorectal.
So it's clear that it's not going to be indication by indication.
Of course, you know.
At the end of the day with the FCA that that speaks I can tell you that with the European authorities, when we've aligned the requirement and discuss with them for phase III day.
Mexico.
Debt colorectal resection is debt the worst case of abdominal and this could serve as a general ophthalmic.
Is it trying to conserve and abdominal and indication and.
Later on when and we won't be re initiating ghost town and.
And I think to get Daytona.
And related surgery.
I believe we could use debt to expand to blow and related indication.
And whether we will need.
Some additional safety data it is not clear, but this is something that will be discussed and for when.
And when we have the phase III data that's.
But clearly, it's not going to be and indication by indication.
And your second question was regarding our priority and.
And how we are looking at Q2 versus the oncology. So so first of all our highest.
Richie and other main focus and as soon as he has.
And it is going so shield one nowadays.
Now that we got the breakthrough therapy designation and for all this discussion and understanding that.
And sufficient to get an NDA, we put all the airports on debt and all the resources and.
And that.
Secondly.
Taxi show too and.
And.
That's a program for the kinds of program.
Preclinical stage so the resources that are required for the cash.
I mean three years are relatively modest.
So it's high priority and we see a lot of value is going to be publishing so and additional preclinical data and brain cancer and and we're very excited about this program share two I think for yourself.
And limiting factor for the approval is growing at a more modest pace.
To allow us to follow and the resources, but still it is a priority we are opening centers and <unk>.
Is that once we finalize.
We have we will have resources that could be the first to show too and this is exactly the flow, but we're not holding on the trial at this stage.
Great. Thank you very much.
Very helpful.
Thank you.
Your next question comes from the line of Gary Nachman from BMO capital.
Hi, good morning.
For shield, one and the pace of enrollment over 300 patients enrolled what what's the pace to get to 502. When do you think you'll have the results from the sample size re estimation I think you'd previously said three Q and it seems like it could be tough to have the topline data by the end of the year. Even if you are going to be at the low end at around 600.
Like you said <expletive> Weil.
And maybe just comment also you know how many of the 60 sites have been activated I think it was two thirds and the last call.
And then also it sounds like to commercialize the flex 100, you're leaning more towards partners. At this point is there still a chance you would commercialize on your own. So just talk a bit more about how far along you are with partnership discussions and maybe how soon you could announce that and if that would provide some non dilutive capital for you.
Right right, so with regards to the Batesville for home and so as we said we've passed a free upgrade for shield, one and we are almost at 400 with the both share and wanted to add.
And the last a few months have been quite strong and are getting stronger.
I'll just close on many of the 60 are open and.
Besides from day to set and.
And we haven't tapped dates yet, but we are happy with the level of opening centers and also the level of free equipment within those centers.
And the 500 is still remains where we were thinking and that it will happen and we should be at.
And of third quarter and.
And the early October.
For the 500 with this timeline and.
September early October for the.
500 sales.
I believe we should be.
If we stop it and nowhere and for the end of the year.
Saying that of course, you know there is still some.
Coffee.
And to show again, and we will need to see how this will react and effect.
Enter.
Up until now and we haven't seen any effect against the numbers are changing quite rapidly with the world. So we will evaluate that as we go but we feel very confident with regards to the 500 at the end of September or early Q4 and.
With that.
Getting to the 600 by the end of for you.
You were also asking with regards to commercialization so maybe.
Go one step backward.
And we're still and we have to start with we were leaning towards low.
Licensing out of U S.
And the discussion that we have out of U S.
Europe far east and this is something that we have no intention on commercializing on our own and those territories. So we are quite pleased with those discussions of course.
Processes take a while and.
And.
We cannot.
Evaluate what will be the exact timing for you.
With regards to the U S.
Clearly said that we wanted to have.
And this is why we and we made the investment on putting a plan for commercialization and what is required in terms of free sources timeline Irene.
And this is what we've done and a lot in the previous quarter and.
And we have a very detailed and it was up for.
For us.
Our service provider and we.
We're also evaluating some potential co promotional.
Do not see ourselves.
Having losing control on the product.
And so much for.
And for almost a 10 year and stuff.
Okay, Great and then just one more on the uncle plus so it makes a lot of sense that you're going after brain tumors for gist.
Maybe you could describe how it would be administered with tumor resection would it be the same as for us the size.
Would you need a different formulation or it would be a similar formulation is what you have with duplex 100, and also will you consider other indications to evaluate over the next year or really just going to focus on brain tumors for the time of day.
Great. Thanks, Thanks for raising debt. So we we mentioned that we've seen todays prepared remarks, we.
We've started working with different kols and and part of those Oh ignore a surgeon to evaluate and see how.
Taxi and complex who's going to be administrate and discussed it seems quite fairly easy.
For the administrative at this stage the actual administration is going to be fairly simple.
<unk>.
The children's respect because we are talking about brain tumor and the reason residual.
This is left and.
This area there is a quite significant GAAP.
Duplex won't be administrative debt.
Releasing their chemotherapy for several weeks.
We will.
And for sure was regarding the formulation and so on complexity and novel formulation of course.
We do have some similarity budgets and novel formulation with novel chemotherapy.
Several months to years to come up quickly for relation and snack.
And quite fast with a preclinical stage and this is why we are calling for that.
Off the ball sharing day and time zone.
Development program, but it's just different.
All formulation.
Which of course is.
And then separately from all our 101 patent that are already there.
Okay and will you look at anything else, besides brain tumors, where that debt.
The focus for now.
So we've already done some work with other solid.
And there we are focusing initially on solid tumors and seemed very nice preclinical data.
And we think that for us at this stage it makes more sense to be more focused to get some progress to get to the FDA.
Later on when we get.
Some additional data we don't see in terms of prioritization and focus for it makes sense in terms of extending because we do believe that uncle places could be used and more than one indication, but for now we are focusing.
Moving ahead to the clinic.
Okay, great. Thanks for the additional color.
Thank you.
Okay.
Thank you. Your next question comes from the line of.
And he Prasad from Barclays.
Hi, good morning, and thanks for taking the questions great to see the progress.
Couple of questions, maybe just going back to Gary's question on brain tumor.
Were there any other reason.
The reasons for you to selected for that indication apart from the fact that there's a day very challenging tumor treat systemically.
And I'm asking because I just wanted to think about how we thought about other tumors, which are much smaller.
Common like breast and prostate and why do you to rule them out. So that's one and secondly on the progress and chilled and one from some update to that seat and it looks like you'll activate and 46 sites currently out of the 60. Please correct me if I'm wrong and thanks.
Thanks, Thanks, Raj and I'll start with the first question, but just I couldn't hear you well how many centers you mentioned I talked to and I can wait and 46 out of the <unk> site 60 centers sales.
Is this right and the other 48 and going to back weighted.
Okay.
I'll start with the.
Yeah.
With the uncle Capex.
Great question, because I think it's.
Also demonstrate the power of our approach though of course, we went through to cash it because it's a it's an unmet need.
Maybe the highest unmet need and cancer today.
It's free.
Nicely to our approach one of the challenges with great humor.
No it <unk>.
It's different for the majority of the trucks out there for systemic drugs too.
Great.
If they could have.
Rich the brand and maybe they would be and effective.
And not able to reach and what's nice about politics approached about the flex approach debt.
Getting where it needs to be there is no need to use systemic administration. We're just there. So we have the ability to at.
And at least for chemotherapy, where it's needed.
That's one aspect the other aspect is the.
Debt.
The ability to have a prolonged and where they used a phenotype to use chemotherapy locally defensive tapped into faster.
[noise] drives conversion.
So successful drugs that are having.
And I'll step had the low code and the prolonged low cost control released its we are positioned.
And this could be a real game changer and for me.
Mentioned.
Okay.
So those are the two main reasons to pursue train two in addition to the fact that it's a huge unmet need.
Your second question was regarding the number of centers that are open and so we didn't disclose the exact number but it's a higher number than that.
And then the 46 I don't want to go into these ex so because this is not something that we.
We stated we did update on the actual patient, which is of course and most important day numbers.
These days.
Thank you that's helpful and both the for the questions.
Thank you.
Yeah.
Thank you.
Your next question comes from the line of Elliot Wilbur from Raymond James.
Hi, guys. This is actually Michael per Lori on for Elliot Thanks for taking my questions.
So first one I guess piggybacking off of the prior partnership discussion.
Just wondering how the nature of discussions have kind of changed now that the FDA indicated that for a single phase III trial might be sufficient to file and N D. A.
And then also wondering if you guys have any potential plans for it spend and your manufacturing capabilities to address the higher expected demand.
And do you know after the first 30 months of launch.
Thank you.
Thank you so I'll start with you.
Good question, we do have plans on expanding the mining sector more than planned.
Waiting.
Rents are options as well as the starting to plan.
And for that and this is quite progressed, we're not going to take any financial committees at each day, but we are looking on auctions debt could be utilized quickly.
We have the green light for the data. So this is something that a lot of.
Ours is and that's being put into it for.
And I do I think the requirements evaluating day.
The property that you say debt doing some planning.
And as well as understanding what kind of machinery will be needed for the full scale manufacturing. So the day ties there and we have the ability.
Relatively.
And a short time to implement these plans with regards to your second question, which was on on.
What effects had a.
The breakthrough therapy and the fact that are we are not we need only one phase III.
Good day.
And additional discussion that's one thing that we did and set fire to that.
But it's also good cost for that too.
And we want that.
This is something that needs to that discussion for me to be.
Relatively.
Fast track, if we want to get them to that point prior to data if it's going to be.
We're going to sign off the other day.
It's a different tariffs and text and talk with the agreement.
Okay. Thanks, and then one more quick one just on the indicated cash runway out to the second half of 2020, two and this seems a little bit more favorable than than your prior commentary just wondering if that is solely because of the single phase III trial.
Indication from the FDA or if there are other moving parts that are.
[noise] effect and the cash runway.
That's exactly that.
The one and if they see it gave us some more flexibility.
Okay perfect. Thanks for taking my questions guys.
Thank you thanks for that.
Yeah.
Thank you.
Your final question at this time coming from the line off the tree and minimally from allowance Global partners.
Yeah.
Hey, guys. Thanks for taking my question and I was wondering if you could speak a little bit too and you alluded to it on the call.
The Delta varied I know, it's been an issue and Israel in particular and and to hit and U S are.
Currently can you speak a little bits and delta vary and how that maybe impacting.
The shield, one and just.
Some other questions as well it seems it seems like it might be pushed into the first quarter 'twenty two for the data.
300, and easy to five or six and for the phase for the first phase III for she is tier one you can speak to that and I don't think pushing back a quarter is that big a deal, but what are your thoughts and what do you think you might have a better insight that might happen.
Sure sure so for now and we don't see and in fact, it doesn't mean that you know we've we've been with this pandemic for long enough to understand that exchange and quickly and you cannot really ex.
Predict what will be the.
Situation and debates to come and.
But for now we don't see and impact on the recruitment trend probably one of the favorite.
Favorable things.
Most of our patient a cancer patient and.
This is deemed to be high priority surgery, and those surgeries on and off delayed at least a and also at this stage of the pandemic with regards to the time, we said all suddenly not.
Shelf registration.
Ex.
At the low end, we still think that this won't be.
This year, if we decide we want to go for a larger sample size sample population patient population that will ex back.
Debt.
The study.
No we don't see any day and she said, we don't expect anything dramatic.
We'll be able to give.
More exact timelines when we reached the 500 and evaluate the exact number of patients.
Required.
Okay and my quick follow up could you put any color around other commentary.
From the from the FDA provided the study results are adequate.
And as you can put around that for us.
I was looking out looking outside looking in and will be adequate for what might not be.
So that's what we have presented and the protocol that's what it means adequate it means that what we presented and in terms of for statistical plan.
So just to comply and it was presented that Theres no need for <unk>.
Hi, Baas, and what was presented to the FDA and approved.
Alright, great. Thank you final question and then any thoughts on timing on when you might have.
And you also review I know a partnership of hard to put time and not and you think it's post.
The shield one data for.
And that was from Central partners ex U S revenue in the U S.
It's hard to say at this stage.
And we wouldn't want to commit that this day, what will be the Taiwan and whether those will be signed after the data I'll try and for the data.
But as we said already.
With the discussion and the level of interest.
The 100 is getting.
Great. Thank you for taking the questions.
Thank you Jim Thank you very much.
And I liked.
I mean for any closing comments.
Yeah.
Thank you for joining <unk> second quarter 2021 day.
Gross.
I would like to Madrid, and we're excited about this program.
We have achieved.
Specifically in our debt fixed 100 clinical program revenue.
And as a significant opportunity.
It is.
We remain debt for them to our team members and therefore.
And really.
Process.
For me Smith.
And bill.
Cool.
Uh huh.
Efficiency lower.
And with your first 100.
And that's kept for Baidu for sure that's fine.
Thank you.
Thank you, ladies and gentlemen, and that does conclude your call for today. Thank you all for participating and you may now disconnect.
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Thank you all for participating and Poly peak second quarter 2021 earnings conference call.
Joining me on the call today will be a mere weisberg, Chief Executive Officer, and <unk> chart, because oxo Braun executive Vice President and Chief Financial Officer.
Earlier today <unk> released financial results for the three and six months ended June 32021.
Copy of the press release is available on the investors section of the company's website.
Www dot com and <unk> Dot com.
Like to remind you that on this call management will make forward looking statements within the meaning of the federal Securities Laws. For example management is making forward looking statements.
And when it discusses the expected recruitment of trials.
Timing of trials and release.
The results thereof.
Passed for the company's manufacturing facility the company's pipeline.
Potential benefits for flex and our complex.
The companys potential partners and sufficiency of cash to fund future operations.
Forward looking statements are subject to numerous risks and uncertainties.
Many of which are beyond our control, including the risks and uncertainties described from time to time and our SEC filings.
Our results may differ materially from those projections.
These statements involve material risks and uncertainties could cause actual results or events to <unk>.
Clearly differ.
You should not place undue reliance on these statements.
I encourage you to review the company's filings with Securities and Exchange Commission, including without limitation, the Companys forms 20-F, and 6K, which identifies.
Specific factors that may cause actual results or events to differ materially from those described and as forward looking statements.
<unk> disclaims any intention or obligation expect.
Except as required by law to update or revise any financial projections for forward looking statements, whether because of new information future events or otherwise. This conference call contains time sensitive information and speaks only as of the wide broadcast today August 11.2021.
And with the completion of those prepared remarks, it's my pleasure to turn the call over to Amir Weisberg CEO Amir.
Yeah.
Thank you Bob.
On behalf for the product and team.
I would like to welcome everyone for our second quarter 2021 earnings growth.
And really begin today with some brief introductory comments and then decline.
And by the day nice partner business.
And the review of our financial results. After the debt we will open the call for your questions.
We have recently achieved significant progress in advancing our.
Many development programs and in continuing our progress towards becoming a commercial company.
And that's you know we are currently in a large phase III program with all other leads us.
Next one for the prevention of surgical site infections or exercise.
Ssi and accounts for around 20% of all hospital acquired infections and.
And the U S, resulting and extended hospital stays and.
And for the admission and anything up to $10 billion and NOI.
And medical costs.
I will provide further details on this program shortly.
Cited to report today that our ongoing <unk> onetime and abdominal surgery continues to proceed as planned and we are succeeding and accelerating enrollment into the study.
Importantly, following decitabine and meeting request to the FDA and the second quarter. We received a written response from the agency.
And I think our development plan for this next one.
The FDA indicated that boulevard.
Results.
And the clear our proposal for a single phase III pivotal studies, and one would presume enough evidence for clinical efficacy and safety to support approval.
And also reflects 100 for the prevention of Ssi and colorectal surgery.
We are very happy that our proposed development plan for the professional and approval of <unk> 100 has been accepted.
This will reduce the anticipated cost for the program and provides us with additional financial flexibility overhaul.
Q2, our second phase III trial and abdominal surgery.
Further and the durability criteria, including minimally invasive surgical procedures.
And it is also advancing as expected with new sites continuing to open on an ongoing basis.
I'm also pleased to reported promising uncle clicks development platform and oncology continues to progress quickly.
And I'm excited to announce today with our initial target and.
<unk> for <unk>.
We'll be brain tumor were low.
And you literally can be a game changer and cloud will provide further detail on the photos and.
Planning for next steps for.
And complex shortly and you can see only business recently achieved important progress throughout our business.
We also continue to be supported by a strong balance sheet, which we expect to be sufficient to complete the distributed one study to conduct and two and prepare for the submission of and theory to the FDA and swim and further advanced our own complex development platform.
I will now turn the call over to <unk> to provide you with some further updates on all the other businesses and cloud.
Please thank you for it.
Thank you Amir and thank you all again for joining us on the call and I would like to begin with a brief discussion on the status of our pipeline.
The pace of enrollment in the shield one trial has been strong to date and is expected to continue to accelerate.
We now have over 300 patients enrolled into the study and based on the current environment. We believe that day recruitment rate will continue to gain momentum in the months to come.
Approximately 70% of the patients currently enrolled in shield, one has a colorectal cancer diagnostics and.
Similar to the 74%, Steve and I was successfully completed phase two trial.
Importantly, the high priority and nature of the surgical procedures and makes them less influenced by the ongoing COVID-19 pandemic worldwide.
Other reasons for colorectal surgery and include mainly Crohn's disease, and inflammatory bowel disease and it was also seen and our completed phase two of them right.
Okay, and the data safety monitoring committee and charge with the review of accumulating safety data and study conduct for the shield one study.
And why it's recommended to continue the study without modification, meaning that no major safety issues related to deep pick 100 being observed and shield one to date.
And as a reminder, our plan is to enroll 616, two 900 patient within 60 centers and the U S EU and Israel.
One 500 patients have completed the first months follow up and have been evaluated for the primary endpoint and.
The study design provides for the blinded sample size re estimation based on the overall infection rate observed in the study.
And only the low end of around 650 patients planned to be enrolled is necessary. We continue to anticipate there's variability.
Top line data from the shield, one and the end of this year.
Moving gold and silver.
And you indicated while on the positive results from shield one needed for FDA approval. We continue to move forward with shield, which has broader eligibility criteria and shield, one including minimally invasive surgical procedure.
She has to also continues to progress and plan and although our focus here remains on opening centers. We are pleased with the current rates of enrollment in this study as well.
Total enrolled patients in shield, one and shield to collectively is now approaching 400 patients.
Moreover, we have recruited in just the last year during the pandemic approximately the same number of patients that.
We're in growth into all five prior clinical trials conducted by the company sees and cooperation.
Now I'd like to further elaborate on the stock and football and complex.
Intra tumoral chemotherapy product candidate for solid tumors.
Including tumors with a cumulative uptick resistant.
And as a reminder, on complex provide local prolong and control exposure to dose I think step.
One of the most widely used chemotherapy agents and.
And the intraoperative tumor resection and said.
The control and prolonged growth.
And the residual tumor size may have a critical impact on the prevention of local tumor reoccurring and the potential spreading of cancer itself.
And ultimately improve the overall survival rate of cancer patients.
You will recall that we generated compelling data and <unk>.
Animals that we are excited about and different solid tumor indication.
In addition, we expect on complex to significantly reduce the non toxic systemic exposure to chemotherapy one of the important attributes of successful local delivery and cancer therapy and.
And our various animal models to day has indeed shown and very promising safety profile versus systemic chemotherapy.
And some have noted earlier, we are disclosing today that brain tumor has been selected as the initial indication for the uncle Plex intra Tumoral therapy program.
And is currently almost no meaningful treatment option for brain tumors, primarily due to the limited ability of existing approaches.
Penetrate the blood brain barrier.
Due to the localized nature of Banca, we believe it is highly beneficial and.
Compared to systemic treatment and <unk>.
And specific indication and it.
Addition, and its ability to produce the control to leave room for grass seed drug and generating a high local concentration and weak.
My father and hands on Capex significant potential <unk>.
Importantly, we expect definitely ability of traditional on complex preclinical data and crane.
Humor shortly.
We believe these result, low Florida support and work towards the completion of our preclinical package for that.
Finding of a pre I and D request with the FDA and the.
Coming back to <unk>.
Pension and <unk> initiate a phase one clinical trial next year.
We also continued spend on network top experts and kols around our own Capex development program to support our efforts in this promising area.
We firmly believe that aren't complex has the potential to become part of the standup of ease.
And the tumor resection surgical setting within multiple solid cancer types.
Going back to duplex 100, and from a commercial perspective, we have developed and launch plan debt details all the activities that will occur from now until.
For the various functions and a quality, including sales marketing market access and medical needs.
Edition and read.
Those plans have been developed to assess their hiring needs and timing for each of the different function as well and the infrastructure that will be needed and.
Separation for launch we are currently in discussions with a number of launch and excellent service provider.
For the commercial launch.
In parallel we also remain in discussions with multiple large and mid sized strategic partners.
And with significant presence and experience selling and hospital and.
Operating room for potential collaboration and Europe and Asia.
And the U S. We are in contact with several large and midsized pharmaceutical and medical service company, which we believe will be ideal commercial partner for duplex 100.
These companies are leaders in commercializing city Coke products and medical devices, and strongest published commercial infrastructure demonstrate a detailed understanding clinical and economic benefits and the hospital channel and.
Maintain strong relationships with the hospitals clinical medical and administrative and stuff.
We are progressing with these companies and are quite pleased with the high level of interest and deployed 100 for.
And I move on to our recent financial results I'd like to take a moment to discuss and recent registration statement and we filed with the FCC.
And as it is an important strategic element related to the development of our pipeline.
This shelf filing provides us with critical leverage around a commercial partnership discussion.
Many of which are recurring and lead the company to much larger sized and Paul.
Moreover, this shelf filing allows for a father.
Father, and flexibility regarding the structural for potential partnership agreement.
While we have no immediate plans to utilize this shelf filing we believe it to be a prudent financial tool to have and play.
Okay.
And finally I'd like to welcome Dr. Anthony Jason and go to policy.
So Senegal will serve as senior medical director and will be responsible for developing medical infrastructure in the United States and will contribute to the Companys NDA submission and commercial launch of T. Plus 100 Doctor Senegal is a colorectal surgeon with a long track record.
Okay, Debbie surgery proxy and has significant experience and.
Health co startup company.
Backlog as of <unk>.
And Jim and biopharmaceutical innovator as well as unique understanding of the budgeting process in hospital system will prove invaluable for pursuit.
And of reducing the clinical and financial burden of exercise.
With that I will now review our recent financial results.
Let's begin with quality balance sheet information as of June 32021, the company had cash cash equivalents short term deposits and loans and deposits.
$52.9 million and compared to $66.6 million and as of December 31st 2020 cash used in operations for the three months ended June 32021 totaled $8 million.
We expect that our current cash runway will extend into the second half of 2020 two and remained confident this strong balance sheet will allow us to complete our first phase III trial shield, one and abdominal soft tissue infection to preparing for the submission of an NDA for <unk>.
100, and father and advance our own complex programs towards phase one trial.
Now, let's turn to our income statement and research and development expenses for the three months ended June 32021 seven.
Seven pull for point $4 million compared to $4.3 million taller and the same three months period of 2000 and tweaking.
And being increased due to the ongoing shield, one and shield two phase III clinical trials and abdominal century mile.
Marketing and business development expenses for the second quarter for 2021 was $700000 compared to $300000 for this.
Same period of 2020.
These expenses increased primarily due to and increased marketing and business development personnel.
Our offices in new Jersey, and and increasing the market facing activity and as we continue to build our commercial infrastructure.
General and administrative expense for the second quarter of.
2021, with $2.4 million compared to $2.6 million and the prior year period. The decrease in general and administrative expenses was due to lower noncash share based compensation expenses.
For the second quarter 2021 to come to and you had a net loss attributable to ordinary share of $10.5 million as compared to $19.1 million and the prior year period.
We will now open the call to your question operator.
Thank you.
As a reminder, ladies and gentlemen, if you wish to ask a question Tom and one on <unk>.
Telephone keypad and wait.
For name to be announced.
Your first question today comes from the line of Brandon Folkes from Cantor Fitzgerald.
Alright, and thanks for taking my questions and congratulations on all the progress.
Maybe just firstly on the potential for label expansion and.
Yeah, and your discussions with the FDA have they given any color in terms of whether this is going to have to be a sort of indication by indication label expansion.
There's potential yeah, maybe for shield two to drive broad label expansion.
And then secondly, and maybe just as it goes for do you intend to focus.
On Q2, and conquer sick any color and prioritization, there or should we expect that day will both continue.
Thank you.
Thank you Brandon and it's good to have you on this call.
With regards to label expansion and it is clear to us for my discussions with the SBA debt.
And just going to be indication by indication, that's quite different and that already for a lot of discuss.
Discussions with regarding general abdominal colorectal trial, it's clear that day something that.
Could be done and in some of our correspondence and also Q I D. P. We got a broader abdominal general abdominal indication.
And as colorectal and so it's clear that it's not going to be indication by indication.
Of course, you know at the end of the day with the FCA.
And that speaks I can tell you that with the European authorities, when we've aligned the requirement and discuss with them. The phase III. They recognize that colorectal resection is debt the worst case of abdominal and this could serve as a general abdominal and the trials and that concern.
And then if Tom holiday vacation and.
And later on when and we won't be green and initiating a trial and.
To get there.
Daytona and.
Born relate to surgery.
I believe we could use debt to expand to bond related indication.
Whether we will need a sound.
Additional safety data it is not clear, but this is something that will be discussed and for when we have the phase III data that's.
But clearly, it's not going to be and indication by indication.
And just your second question was regarding our priority and.
And how we are looking at Q2 versus the oncology. So so first of all our highest volume.
Richie and other main focus and that's it.
Is going so shield one now.
And now that we got the breakthrough therapy designation and from this discussion and understanding that.
Sufficient to get an NDA, we put all the airports on debt and all the resources and.
And then.
Secondly.
Taxi show too and.
That's a program for the cancer program is still it's free.
Preclinical stage. So the resources that are required for the coming three years are relatively modest.
So it's high priority and we see a lot of value, we are going to be publishing sue and additional preclinical data and brain cancer and and we're very excited about this program share too.
And all.
And limiting factor for them for their approval is growing at a more modest pace.
To allow us to balance the resources, but still it is a priority we are opening sector and our assumption is that once we finalize what we have we will have resources that could be the first to show too and this is exactly the plan, but we are not holding onto the trial at this.
Stage.
Great. Thank you very much.
And that's very helpful.
Thank you.
Your next question comes from the line of Gary and that trend.
B and capital.
Hi, good morning.
For shield, one and the pace of enrollment over 300 patients enrolled what what's the pace to get to 502. When do you think you'll have the results from the sample size re estimation I think you had previously said three Q and it seems like it could be tough to have the topline data by the end of the year, even if you aren't going to be at the low end at around 600.
Like you said <expletive> Weil.
And maybe just comment also you know how many of the 60 sites have been activated I think it was two thirds and the last call.
And then also it sounds like to commercialize duplex 100, you're leaning more towards partners. At this point is there still a chance you would commercialize on your own. So just talk a little bit more about how far along you are with partnership discussions and maybe how soon you could announce that and if that would provide some non dilutive capital for you.
Right right. So with regards to the peso for enrollment tool as we said we've passed a free upgrade for share and we are almost at 400 with the both share and wanted to add.
And the last a few months have been quite strong and I'm getting is and a stronger weighted.
I'll just close on many of the 60 are open and with.
Besides from the Tusa and we Havent top date, yet, but we are happy with the level of opening centers and also the level of free quickbooks within those centers.
And the 500 is still remains where we were thinking and that it will happen and we choose the act of third quarter end of September.
And the early October.
For the 500 with this time and idle.
September early October for the five.
We still believe we should be fine.
If we stop it and lower and for the end of day year.
Saying that of course, you know there is still some.
It is.
Starting to show again, and we will need to see how this will react and effect of the center.
Up until now and we haven't seen any effect against the numbers are changing quite rapidly over the world. So we will evaluate that as we go but we feel very confident with regards to the 500 at the end of September or early Q4 and with debt.
Getting to the 600 by the end of for Ya.
You were also asking with regards to commercialization so maybe.
Go one step backward.
And we're still and we have to start with we were leaning towards low.
Licensing out of U S.
And the discussion that we have out of U S.
Europe far east and this is something that we have no intention on commercializing on our own and those territories. So we are quite pleased with those discussions of course.
Processes take a while and.
And we cannot.
Evaluate what will be the exact timing for it with regards to the U S.
We clearly said that we want to have something going on and this is why we we made the investment on putting a plan for commercialization and what is required in terms of resources timeline and hiring.
And this is what we've done and a lot in the previous quarter.
And we have a very detailed plan and it was.
For a week.
Our service provider and we are also evaluating some potential co promotional and so we do not see ourselves.
Losing control on the product that we have invested so much for almost 10 years now.
Yeah.
Okay, Great and then just one more on the uncle plus so it makes a lot of sense that you're going after brain tumors for gist.
Maybe you could describe how it would be administered with tumor resection would it be the same as for US the size. So would you need a different formulation or it would be a similar formulation is what you have with Eplex 100, and also will you consider other indications to evaluate over the next year or are we really just going to focus on brain tumors for the time.
Okay.
Great. Thanks, Thanks for raising debt. So we we mentioned that briefly and today's prepared remarks.
We've started working with different kols and and part of those Oh ignore a surgeon to evaluate and see how.
Taxi and complex.
Flex is going to be administrative and discuss it seems quite fairly easy.
For the administrative at this stage the actual administration is going to be fairly simple.
Hmm.
The share Mary's respect because we are talking about brain tumor and the reason residual.
This is left and.
This area there is a quite significant GAAP that duplex will be administrate effects and.
And really seeing their chemotherapy for several weeks.
And we with.
Your second question was regarding the formulations, so uncle flexes and novel formulation of course.
We do have some similarity budgets and no.
Formulation with novel chemotherapy.
And they're all minus two years to come up with external relation and snack.
And quite good fast with a preclinical stage and this is why we are calling for debt.
And comfortable sharing data and time lines.
It's development program, but it's a different novel formulation.
Which of course is <unk>.
And separately from all our 101 practices are already there.
Okay and will you look at anything else, besides brain tumors or that that's the focus for now.
So we've already done some work with other solid.
Solid tumor we are focusing initially on solid tumors and it seems very nice preclinical data.
And we think that for us at this stage it makes more sense to be more focused to get some progress to get to the FDA.
Later on when we get.
Some additional day, so we don't see in terms of prioritization and focus for it makes sense in terms of our expanding because we do believe that uncle place could be using more than one indication, but for now we are focusing.
Moving ahead to the clinic.
Okay, great. Thanks for the additional color.
Thank you.
Okay.
Thank you. Your next question comes from the line of.
And she Prasad from Barclays.
Hi, good morning, and thanks for taking the question great to see the progress.
Couple of questions, maybe just going back to Gary's question on brain tumor.
Were there any other.
Reasons for you to selected for that indication apart from the fact that this is a very challenging too much free system equally.
And I'm asking because I just wanted to think about how we thought about other tumors, which are much more.
Come on like breast and prostate and why do you get rolled them out. So that's one and secondly on the progress and shield one for.
Some updates that I had seen and it looks like you activate and 46 sites currently out of the 60. Please correct me.
Wrong and thanks.
Thanks, Thanks, Brian I'll start with the first question, but just I couldn't hear you well how many centers you mentioned I talked to and activate at 46 auto <unk> site 60 centers sales.
Is this right and the <unk>.
And I'm going to back weighted.
Okay.
I'll start with the.
And.
With the encore six and this is.
Great question, because I think it's.
And also demonstrate the power of our approach though of course.
We went through to cash it because it's a it's an unmet need.
And maybe the highest unmet need and cancer today, but it fits so.
And actually to our approach one of the challenges with great humor.
<unk> is the brand slot there and again, it's the BBB.
And for the majority of the trucks out there for systemic drugs to reach the green tax.
If they could have.
And reached a brand and maybe they would have been affected.
And not able to reach and what's nice about politics approached about complex approach that you.
Getting where it needs to be there is no need to use the systemic administration. We're just there so.
So we have the ability to really.
And at least for chemotherapy, where it's needed.
That's one aspect the other aspect is the fact that we have.
The ability to have a prolonged or at least there have been attempts to use chemotherapy locally.
Defensive tapped into faster.
[noise] drives conversion and not so successful drugs that are having.
And if that had the low code and the prolonged local control relief that we are positioned.
And this could be a real game changer and I'm here.
Mentioned.
Yeah.
So those are the two main areas and to pursue green.
In addition to the fact that it's a huge unmet need.
Your second question was regarding the number of centers that are open and so we didn't disclose the exact number but it's a higher number than the 46 I don't want to go into the exact number because this is not something that debt we.
We stated we did update on the actual patient which is of course, the most important day.
And I'm good.
These days.
Thank you.
Helpful and both the questions.
Thank you.
Yeah.
Thank you and your next question comes from the line of Elliot Wilbur from Raymond James.
Hi, guys. This is actually Michael per Lori on for Elliot Thanks for taking my questions.
So first one I guess piggybacking off of the prior partnership discussion.
Just wondering how the nature of discussions have kind of changed now that the FDA indicated that for single phase three trial might be sufficient to file and N D. A.
And then also wondering if you guys have any potential plans for expanding your manufacturing capabilities to address the higher expected demand and <unk>.
After the first 30 months of launch.
Thank you.
Thank you so I'll start with you.
Good question, we do have plans on expanding the mining sector, it's more than planned.
A waiting the express and options as well as the starting to plan.
For that and this is quite progressed, we're not going to take any financial committees at each day, but we are looking on auctions that could be utilized quickly.
We have the green light for the data. So this is something that a lot of.
Our.
And put into evaluating the requirements evaluating the the.
The property that you say debt doing some planning.
And as well as understanding what kind of machinery will be needed for the full scale manufacturing. So the day time, there and we have the ability now a relatively.
And a short time to implement these plans with regards to your second question, which was on the on.
What effect it had.
Breakthrough therapy, and the fact that and we're not we need only one phase III I think its gaye if it's open additional discussion. That's one thing that we did in fact prior to debt package also gave confidence to everyone.
This is something that needs to that discussion to be had a relatively.
Fast track, if we want to get them to that point prior to data if it's going to be if we're going to sign after the day.
And it's a different tabs and ethics and talk with the agreement.
Okay. Thanks, and then one more quick one just on the indicated cash runway out to the second half of 2020 two.
And it seems a little bit more favorable than than your prior commentary just wondering if debt is solely because of the single phase III trial indication from the FDA or if there are other moving parts that are.
The effect and the cash runway.
That's exactly that.
The one phase three it gave us some more flexibility.
Okay perfect. Thanks for taking my questions guys.
Thank you thanks for that.
Thank you.
And your final question at this time comes from the line of Jim Benoit from allowance global populations.
Hey, guys. Thanks for taking my question and I was wondering if you could speak a little bit too and you alluded to it on the call.
Much of the Delta variants.
It's been an issue and Israel in particular and in Chile, and the U S.
Currently can you speak a little bit for the delta vary and how that maybe impacting.
The shield, one and just.
Some other questions as well it seems it seems like it might be pushed into the first quarter, one and two for the data.
And just over 300 and easy to five or six.
For the phase and for the first phase III Ashish you want you can speak to that and I don't think pushing back a quarter that big a deal, but what's your thoughts and what do you think you might have a bedroom inside if that might happen.
Sure sure so for now and we don't see and in fact, it doesn't mean that you know we've we've been with this pandemic for long enough to understand debt to change it quickly and you cannot really ex.
Predict what will be the.
Situations and debates to come.
But for now we don't see and impact on recruitment and trade probably.
Favorable things in that regard for.
Most of our patient, though cancer patient.
And this is deemed to be high priority surgery, and those surgeries on and off delayed at least not at this stage of the pandemic with regards to the timeline, we set all suddenly and our recent shelf registration.
If we are at the lower and we still think that this won't be.
This year, if we decide we want to go for a larger and.
<unk> saw some for population.
Collection.
Well ex back extend the study, but not we don't see any and he said we don't expect anything dramatic we will be able to give.
More exact timelines when we reached the 500 and evaluate the exact number of patients.
Required.
Okay and my quick follow up could you put any color around the other commentary.
From the from the FDA, providing the study results are adequate.
And as you can put around that for us.
And just looking out looking outside looking in and will be adequate for what might not be.
So that's what we have presented in the port of call that what it means adequate for me is that what we presented in terms of for statistical plan and we May see the statistical plan and it was presented and Theres no need for <unk>.
Higher bond and what was presented to the FDA and approved.
Alright, great. Thank you final question and then any thoughts on timing on when you might.
The other review I know a partnership and hard to put time and how do you think it's post.
The shield one data for.
For announced residual partners ex U S or even in the U S.
It's hard to say at this day.
And we wouldn't want to commit to at this stage what will be the Taiwan and whether those will be signed after today, so I'll try and for the data.
As we said already we see.
With the discussion and the level of interest debt.
Duplex 100 is getting.
Great. Thank you for taking the questions.
Thank you Jim.
And so very much.
Thank you and I'd like to have got Ya man for any closing comments.
Yeah.
Thank you for joining us.
And second quarter 2021 day.
Cool.
I would like to reiterate how excited and.
Okay.
We have achieved.
Good day.
Typically in our day 100 clinical program.
And the significant opportunities for Tonight.
Uh huh.
We remain debt for them to our team members and therefore.
And I really.
For Ya.
For me for a minute.
And bill.
Good day.
Uh huh.
Efficiency lower.
Sure.
And that's one of the Hungary and uncle player.
And that's kept providers and patients.
That's fine.
Thank you.