Q3 2021 PolyPid Ltd Earnings Call

November 10, 2021

[music].

Good day and thank you for sound Goodbye welcome to the totally paid third quarter 2010 to one conference.

Time, all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During the session you would need to press star one on your telephone. Please be advised that today's conference is being recorded if you require any further assistance. Please press.

So I would say, though I would not like to hand, the conference over to your speaker today, but you did please go ahead.

You all for participating in <unk> third quarter, 2020, One earnings conference call.

Joining me on the call today will be a mere whites bird chief Executive officer, and be quite shocked because OXXO broad executive Vice President and Chief Financial Officer of Hollywood.

Earlier today.

I would get released financial results for the three months and nine months ended September 30th 2021.

Copy of the press release is available in the investors section of the company's website.

Www Dot <unk> dot com.

I'd like to remind you on this call management will make forward looking statements within the meaning of federal Securities Laws. For example management is making forward looking statements discusses the expected recruitment for trials.

Timing of trials and results thereof.

The company's manufacturing facility, the company's pipeline substantial benefits of cheap flex 100, and uncle Plex.

The company's potential partners and the sufficiency of the company's cash to fund future operations forward looking statements are subject to numerous risks and uncertainties many of which are beyond our control.

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 that could cause actual results or events to materially differ.

Accordingly shop place undue reliance on these statements.

I encourage you to review the company's filings with the Securities and Exchange Commission.

Clothing without limitation, the company's form 20-F, which identified specific factors, which may cause actual results or events to differ materially from those described in the forward looking statements.

<unk> disclaims any intention or obligation.

As required by law to update or revise any exams from projections or forward looking statements, whether because of new information.

Or events or otherwise this conference call contains time sensitive information and speaks only as of the wide broadcast today remember Ken.

'twenty one.

Without completion of those prepared remarks.

My pleasure to turn the call over to Amir Weisberg.

E L Amir.

Yeah.

Thank you Bob.

On behalf of our team at <unk> I would like to welcome everyone to our third quarter 2021 earnings call.

I will begin today with some brief introductory comments.

I will provide a detailed business update and then she will review our financial results after which we will open the call for your questions.

We continue to rapidly advance our many development programs.

Well as all our commercial preparations and most importantly, our large phase III program for our lead asset <unk> Flex 100 for the prevention of surgical site infections.

<unk> is progressing as planned.

As a reminder, ssi account for around 20% of all hospital acquired infection in the U S, resulting in extended hospital stay and readmission and anything up to $10 billion in annual medical costs.

From a commercial perspective.

As we discussed on our last call we have developed a lunch Glenn that's including all the data for activities that will have from now until launch.

For the various functions, including.

Including sales and marketing formulary access and medical affairs.

In addition, and he spoke plan has been developed to permanent hiring needs and.

For each of the different functional.

As well as the infrastructure that will be needed in preparation for launch.

In addition, we have also engaged a leading launch excellent service provider to support policies regarding this re launch activities in the U S market I'm also pleased to report that our promising uncle Plex development platform initially targeting.

<unk> continues to generate compelling pre clinical data, which the cloud will highlight shortly.

Oh significant our audience Didnt meeting with the FDA, where do we hoped to achieve agreement with the agency on the preclinical and clinical development plans for on Capex.

He is scheduled to take place later this month.

Based on our recent accomplishment policies is well positioned for further clinical and operational success more wherever we continue to operate from a position of financial strength.

We expect that our colon balance sheets will be sufficient to complete the shield one study to conduct two and prepare for the submission of NDA to the FDA as well.

Well as further advanced our uncompleted development platform.

Is that I will now turn the call over to the clock to provide you with some further updates on that.

The clock.

Thank you Amanda and thank you all for joining us on the call.

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 continued to increase over the last several months and we expect an even greater acceleration in.

Enrollment in the coming months.

We now have approximately 480 patients enrolled into this study and based on the current environment.

Anticipating that the recruitment rate.

Increased to 200 to 250 patients per quarter.

As you know during the second quarter of 2021, we received written responses from the FDA regarding our development plan for <unk> 100.

The FDA agreed that our proposal for CECO phase three pivotal study.

The study result that adequate would constitute significant evidence of cleaning kind of efficacy to support approval of duplex 100 for the da Vinci XI in colorectal surgery.

As a reminder, our plan was to enroll up to 900 patients into the study.

60 centers in the U S EU and Israel.

Based on disagreement with the FDA, we have determined that it is in the best interest of our duplex 100 program to utilize the higher end of the targeted patient enrollment range for the study which is approximately 900 patients.

And the clinical perspective, this will help ensure that shield one is well powered and well provide additional data that will potentially be used to further demonstrate the medical and health economic benefits of duplex 100.

As we reached approximately 480 patient we expect to enroll 500 patients by the end of the month and to plan to assess the overall infection rate in the trial. Once these 500 patients have completed the one month primary endpoint follow up.

Tend to father update investors and analyst on enrollments tattoos wants to 500 patients have been enrolled and then again following the blinded infection rate assessment.

Based on the target enrollment of approximately 900 patients.

We now anticipate the last station to enrolling chilled one we'll be doing the second quarter of 'twenty to 'twenty two.

The variability of topline data two months thereafter.

Importantly, we believe the potentially significant commercial and pharma call economic benefits.

Conducting shield one handle.

Yes.

Targeted patient enrollment range.

Oh wait.

Modest the extended timeline to top line data.

From a financial standpoint, because we only need to conduct shield one to potentially receive FDA approval and do not need to ramp involvement in Q2 at an equally robust pace. We now anticipate that our cash runway will be extended to you and 'twenty 'twenty.

You too.

This is an improvement from our prior expectations without cash would fund us into the second half of 'twenty to 'twenty two.

As a reminder, approximately 70% of the patients currently enrolled in shield, one habit colorectal cancer diagnosis at rates similar to the 74% seen in our success.

Successfully completed phase two trial.

Many procedures, primarily consist of those related to chronic disease and IBD.

Finally did that the safety monitoring committee in charge with the review of accumulating safety data and study conduct for the shield. One study has now recommended for the third time to continue the study without modification.

There are no major safety issues related to deep six 100, that's been observed in shield one to date.

Moving onto shield, two our second phase III trial in abdominal surgery, which includes blood related PTT criteria, including minimally invasive procedures. This study also continues to progress as planned although our focus remains on opening centers at a measured pace.

Total enrolled patients in shield two is currently over 100 and safety.

In terms of potential collaboration for the future commercialization of flip flex 100 in the U S. We remain in dialogue with several large and midsized pharmaceutical and medical device companies.

That we believe would be ideal commercial partner for duplex 100.

As I said on our last call. These companies are leaders in commercializing pharmaceutical products in medical devices have strongest stop this commercial infrastructures exhibit a detailed understanding of clinical and pharma corticothalamic benefits in the hospital channel and Maine.

<unk> strong relationships with the hospital clinical medical and administrative stuff.

Importantly, there continues to be a high level of interest in duplex 100 from these potential partners.

In parallel we also remain highly active discussions with multiple large and mid sized strategic partners, all with significant presence and experience selling into the hospitals and operating rooms for.

Potential collaboration in Europe and Asia.

Now I'd like to further elaborate on the status of phone complex.

Tumoral chemotherapy product candidates initially targeting solid tumors, including those that are chemo resistant.

A reminder, on complex provides local prolonged and controls exposure to dust that excel in the intraoperative tumor resection setting.

As you know <unk> is one of the most widely used chemotherapy agent worldwide.

Brain tumors was selected as the initial indication for uncle Blake.

There is currently almost no meaningful keyless era poetic treatment options for brain tumors.

Finally, due to the limited ability of the treatments to penetrate the blood brain barrier due to the localized and prolonged nature of uncle picks. We believe it is highly beneficial as compared to systemic treatments as well as the currently evaluable.

In these devastating tumors that often cannot be fully resected surgically.

We recently reported additional positive preclinical data in two key glioblastoma multi form or G. P. M animal models, demonstrating that a single local treatment a phone call place.

Nishu country inhibited tumor growth and prolong survival.

In addition, a dose response was demonstrated for own complex in the different animal models.

These important results further support our work toward the pre IMD meeting with the FDA to potentially initiate a phase one two clinical trial.

And some even noted we are pleased that we have there.

Meeting scheduled with the FDA for later this month with the objective of coming to agreement on a clinical and non clinical development plan. So on complex in GBM.

We remain focused on potentially initiating a phase one two clinical trial of uncle Plex and G. P. M in 2022.

And continue to expand our network of top experts and Kols around uncle Plex development program to support our airports and these promising area.

With that I will now review our recent financial results.

Let's begin with poly pizza balance sheet information as of September 32021, the company had cash cash equivalents short term and long term deposit of $42 million as compared to $67 million as of December 31, 2020 Kashi.

Used in operations for the three months ended September 32021 totaled $10 million.

Now, let's turn to our income statement.

Research and development expenses for the three months ended September 32021 were $7 3 million compared to $4 $2 million in the same three months period of 2020 the.

The increase in research and development expenses resulted from the increased cost and activities related to the ongoing shield, one and shield two phase three clinical trials and abdominal surgery.

Marketing and business development expenses for the three months of 2021 with $400000 compared to 300000 for the same period of 2020.

General and administrative expenses for the third quarter of 2021, with 2.1 billion consistent with $2 2 million in the prior year period.

For the third quarter of 2021, the company had a net loss attributable to ordinary shares of $9 $9 million as compared to $6 5 million in the prior year period.

We will now open the call to your question.

Later.

Thank you.

A reminder to ask a question you will need to press star one on your telephone to withdraw your question. Please press the pound key please stand by while we compile the Q&A roster.

Yeah.

Your first question comes from the line of Gary Nachman from B and capital markets. Please ask your question.

Hey, guys, good morning, and nice to see all the progress.

First with the decision to go to the higher end of the target enrollment range with shield. One you haven't done a sample size re estimation, yet so could the target number of change depending on that re estimation in the results that you got from that.

And then the other piece that you need a you said that glad to get to 900. Some before 80 currently are in the second quarter or are you factoring any potential headwinds from COVID-19. If there's a resurgence you know how locked in do you think that that timeframe is and then I have a couple of months.

Yeah.

So first good morning, and thank you for that.

Maybe to explain our discussions regarding the <unk>.

900 patient, we should remember that when we designed the trial and when we started we were under the understanding with the FDA that we need to phase III trial in order to get an M D and during this process, we received the breakthrough therapy, which essentially said we.

Finally, we got an agreement with the FDA. This one trial is sufficient and we that as we started to progress we understand that we are going to go to the approval and the marketing stage with only one trial and the second one will totally be modified to a smaller number.

There is no need to do to fully pivotal studies. If you have not requested too and we want to make sure that we have in addition of course to the efficacy.

The primary endpoint, we have sufficient health economic data and marketing that time. This was the decision the 500 just a week.

Or even days in terms of reaching the last patient to 500 as we are now in approximately 400 in Asia and as we said it earlier.

Yeah, and the formal Cogs, we do intend to invest we do not expect to change.

This is our expectation is that this is this will be the number.

Oh, the SMB always at the end.

As part of their charter and the ability to stop US earlier due to overwhelming result, but it's still too early to look at that we.

With regards to the pace of enrollment if you look more at and overview look you can see that during the second quarter, we recruited 100 patient.

During the third quarter, we recruited 180.

Now we are comfortable saying that we expect that this will be.

Getting to the top of funnel the expectation, which is a 250 patient headquarter. So starting from a point to 480 patients that we have no you could very easily see how we get to the second quarter with the last really the last page.

Yes.

Okay. That's helpful and then.

Maybe just a little bit more on the type of partnership discussions that you're having it sounds like it's across all regions, but that you're still planning on commercializing on your own in the U S. Do you know when that you hired someone to potentially help you claim that so I guess I'm just a little confused if you think you will end up.

<unk> in the U S, where you'll find a partner.

Or if that partnership will likely.

More likely be outside the U S.

So.

Partnership I'll separately for a second just to remind everyone of <unk>.

Plan in the U S is to have at what somewhat till say strategic collaboration. So on one hand, we do want to have a boots on the ground and have some level of presence. This is the main markets. We do want to have some presence and putting the plan in place. It doesn't mean that everything in this plan will be.

Execute by Oh now on it could be somewhat positive it will be executed by us and some of it when we do sign a partnership will be executed with a partner that idea.

I have a strategic partner our thinking is that this will probably be signed after we have the data in the U S. With regards to Europe, we are in discussion more than evaluating the partners and keeping them.

And updated.

They tend to where we are and this could fairly.

In Europe, and Asia, and the rest of the World. We do look for licensing agreements those are things that are in discussion.

And of course it is.

Not something we can put a timeline on it.

Okay.

Okay, but even though our licensing outside the U S will likely come after data.

It's hard to say.

It's hard for us to say it depends.

Then there is a point in the sky.

Discussions where data is just around the corner then this won't be the case, but it's hard for us to say at this stage.

Okay, Alright, great and then just lastly on uncle Flex do you have a sense of what the phase one two study in GBM might look like.

You're going to have the pre IDE meeting with FDA, but going in and I'm, assuming that you have an idea. So is that something you can talk about at this point, maybe even just size or you know in.

Any other parts of the protocol.

So we do have a sense because the the meeting with the FDA as we said is this month and we've already submitted the package I think it's best to get the feedback and see if everything that we've suggested in terms of the.

Preclinical and clinical development plan.

With what the agencies and then we can get them on to more detail on that but.

Let's forget the SBA debt.

I know to be the first to react to that and gave us the comment.

Okay I won't be insulted.

Alright, guys. Thank you very much.

Yeah.

Thank you Gary.

Yes.

Your next question comes from the line of from didn't Folkes from Cantor Fitzgerald. Please ask your question.

Hi, Thanks, taking my questions and congratulations on all the progress and I just wanted to drill down a little bit more on the cash runway and understood.

Understanding how are we going to go to the high end of the range in patients in shield one.

And I did hear your commentary on that and reducing the overall number of patients potentially in shield two but should.

Should we think about Q2 timelines, maybe being pushed out somewhat and.

And then.

Maybe just any color in terms of how you're thinking of the bridge from colorectal to a broader label.

Yeah, That'd just be helpful. Thank you.

So you are.

Thank you first of all thank you Brandon for the question because we don't want to give some clarity on that we are evaluating.

How best to pursue shield.

Two and obviously the.

The FDA recognizing that one pivotal trial is sufficient we do not need to have shield two in such a robust.

Hi chose two does have the voucher eligibility criteria that can help us broadening the indication and this is something that there will be updates as we go and get closer to top line results, which shows why this is not something that we will do it now.

But we do understand and.

This develop a mess that they have now with black spot.

We do not need to have shield two as such a large site, so obviously and.

We will need to invest less in shield two in order to bridge the.

Fortunately it appears he criterion.

Four.

Okay.

Oh.

Yeah.

No.

[laughter], that's not my concern.

That's right.

[laughter], Yeah, no I'm not.

But anyway.

[laughter] I, maybe can I just ask a follow up here and you know.

I understand you're probably not going to comment on it but we have seen another company within a different division in the F. D. A.

Came out recently and they go to a narrower label on approval and it's you know it's in the hospital within the play surgical environment the product.

They tend to answer the commentary that the FDA has just asked them to collect additional data on some you know I guess a wider.

Variety of procedures, but.

Really not Aki with efficacy data in those procedures and really just looking at PK PD.

Is that anything you're willing to comment on at the moment.

So I can't really comment because this is something you know we will need to discuss with the FDA, but we are looking at it and this is from our perspective and also looking at other product in the surgery suite. This is very in line of what we see and we see.

In the ER.

Both the mechanism of action of our flex 100.

The area that we are with the flex 100, and anti infective product.

The breakthrough therapy, all these parameters together within Cogs in our in our favor, but this will need to be discussed with the FDA.

When we have that.

The end of phase three meeting.

Great. Thank you very much I appreciate all the color and congrats on the progress.

Thank you.

Yeah.

Okay.

Your next question comes from the line of Bose.

She Prasad from Barclays. Please ask your question.

Hello run so again, so I Didnt mentioned is going to see the progress and are you getting there.

Couple of questions on one on the expense side.

Can you Oh, it doesn't sound wasn't spinoff expenses between shield one unchanged too.

And secondly, with regard to your partnership discussions and as it evolves with the with the progress in enrollment are there any new learnings that you are getting from your partnership discussions made on the commercial side of the clinical positioning.

And anything else. Thanks.

So.

Before I relate to the second part could you repeat your the first part of your question.

Yeah absolutely.

She was and it's great to see that there are no safety signals in shield one and.

Whats the latest expenses between shield one unchanged currently.

Sure So in June.

General I can tell you that.

They were supposed to cost more or less the same.

In terms of that we had talked we were talking about a $20 million to $25 million the cost of each phase III.

So you could expect.

Escalate from that what what could be the same thing we are not stopping show two of course, and we do want to pursue it but we will be modifying it now that we don't need it.

As a pivotal but more as a phase four trial.

Could be reduced in terms of the number of patients that are required with regards to the second question about feedback.

I can tell just a bit of color of what we see.

We are very pleased with the level of interest.

And we see that the interest is not.

Limited too.

Specific lithography, but it's worthwhile and we are also.

Very happy to get some insight on the I've met need in these different geographies.

This is something that's from our perspective is encouraging.

We see both the interest and the unmet need and the cost of it today to the different hospitals and the different health care.

And in different countries and this is very encouraging.

Oh, thank you.

Okay.

Your next question comes from the line of will it be kind of from JMP Securities. Please ask your question.

Alright, great. Thanks for taking the questions I guess the first one on shiel to maybe this is a moot point because it sounds like you're.

I'm going to resize the trial, but just curious if you're also seeing enrollment rates increase and shield. Two is as you see it in shield one.

Yeah.

So we first of all our basic assumption was that recruitment and shoot to will be faster because it's it has approach our eligibility criteria and a few centers that are opened since we started this trial, we see that we see that the exact.

Potentially a trial that will be easier to recruit because of the cultural legibility criteria, but as we said in our formal part we are still at the stage of opening the center so as opposed to.

She was one where we have approximately 60 centers that are opened.

This is not the case yet in Q2 and now that we are fully focused in shield one and this is a pivotal trial for approval we can valid.

In terms of expenses and run way and make sure that we are having shield to Andy I'd be opportune upsides.

She is required for just a broadening the indication and having it as a phase four as opposed to shield, one which is a phase III.

Okay.

Great and then I wanted to dig in a little bit on something you said about.

Shield, one so you're still conducting the interim analysis on infection rates set at 500 patients and I don't think you plan to announce the infection rate, but can you just.

Confirm that and then the comment.

Comment you made about the DSM be looking at the potential.

Potential overwhelming efficacy, but it's it's too early is that does that mean that they haven't looked for efficacy just because you don't have enough patience or they've looked and you don't expect to see anything because there aren't enough patients or what's the plan at 500 patients they're going to potentially.

Potential to stop the trial at that point. Thanks.

So firstly.

To be clear the 500 patient is not all that interim analysis.

So everyone is blinded to it it's not something that we don't open the.

The data at this stage it's a.

And over look I have two.

For the data without blinding it so it's not a real understanding of the efficiency and yes, we will not be able to share the infection rate.

As we said its blinded, but it is it could give us a reassurance into the fact that we are on track and that the number of patient could get up to the point that that we are hoping for with regards to the D. S.

Very sad to see Smb's charter do have the ability to stop the trial based on overwhelming result, this is not something that is unique to ours.

But they will need to have the level of safety that is required before they can even look at it and in our case. This was a minimum of 600 patients 616, if you want to be precise. So when I was saying this is too early that means that.

We are not aware if they look like they are not of course, it's still something that there is no dialogue between us and debuted somebody but.

Leslie This is part of their charter is to look at it.

But first you need to have the minimum of patient in terms of safety.

Got it okay, great. That's helpful. Thanks, and then on the on.

On the cash runway.

How does the ATM contributed.

To that at all it doesn't look like you used it in three key you're just looking at the share count.

Reported but have you used it since the end of the quarter. Thanks.

So this is not something that we are going to update them, except for of course, the financial and as you mentioned it.

Obviously, we haven't used it we did say that we are not going to use it twice that we saw in the quarter and we see no need for that especially now with the sharing with investors that we have extended our cash runway into the end of next year.

Theres no.

Use this tool and this level of a ship class.

Okay. Thanks for taking the questions.

Thank you.

Yeah.

Your next question comes from the line of Jim Molloy from a G. P. Pes ask your question.

Yeah.

Hey, guys. Good evening. Thank you for taking my questions I had a quick question on.

On the <unk> I know, we touched upon and obviously its a less urgency now what is the ultimate ultimate goal on the on the shield to actually notice to shield two on running that now that it's not a priority.

For NDA filing.

This is a run of the safety of what's the what's the thinking on sort of running out.

The shield two trial at this point.

So the show to I have two.

Two objectives, one of course is safety and the second one is to have a poetry of eligibility criteria to broader indications.

Ideally to minimally invasive.

Choose one.

Focused on open procedures is mainly focused on open procedure and shield two will give us the ability to broadening the indications.

Minimally invasive and we are looking also if we will need to have some a small portion of the additional abdominal surgeries.

Without different dialogues with the agency in the European and the FDA. This is not necessarily the case because.

Correct.

Resection.

As the.

So much of the worst case in abdominal surgery.

So that level of infection. There we are looking at that double digits infection rate.

U S and opened up they'll have procedures. So is this is that the worst case of Domino surgery in terms of surgical site infection.

And what's the thinking on on Q3.

The expansion of the bone tissue sternum surgeries, where does it sort of stand and whats.

<unk> seen seeing there now.

Yeah.

As we said this would be something that we will only.

<unk> initiated after we have the top line results.

Chosen why and have our discussions with the FDA on that at the end of phase II meeting and on the labeling.

No.

Yeah.

And then maybe last question on Oracle Plex.

Any thoughts on Docetaxel, the migration from sort of the application side.

I was wondering if you are looking at any thoughts on what we can anticipate there.

Can you repeat the question Tim sure looking at the uncle Plex trial, the local application of Docetaxel.

Any thoughts on you know.

Confidence on keeping the dose tax from migrating from sort of the local applications and obviously the whole idea you use it locally rather systemically.

Sure so.

Thank you for that that's from our perspective. This is what we believe is D.

Added the value of our flex platform.

Our ability to the combination of two ability is the ability to.

B anchored locally to be locally and stayed locally.

As well as having prolonged local delivery.

And also looking in some other local cumulative outgrew antique agent in the G. P. M Arena, we believe that this is why.

Our complex greeting.

Central.

Because of its ability because of the size of the truck that's at 100 micron and its not migrating from the size the size of application the children residual side.

Combined with a prolonged exposure this can potentially cover all the area off the residual tumor site.

Yeah.

Thank you for taking the questions.

Okay.

If you wish to ask a question. Please press star one on your telephone.

Your next question comes from the line of Rob Cellphone machines from H C. Wainwright. Please ask your question.

Hi, This is Bob Allen dialing in for Ron Suraj, you and thanks for taking my question. So firstly have you done any physician based market research and payer research concerning a deep flex 100 commercialization, it's so kind of share some key takeaways.

Sure So and so we have done is very robust study.

Some of which we've already we haven't actually done too, but one more recently are interviewing a T M.

Stakeholders.

With half of it being a surgeon abdominal surgery cardiovascular search engine orthopedic surgeon and the other half being hospital administrator privacy.

He called me too and I think that there are many take hours out of it but the two that is from our perspective, maybe worth mentioning and we can elaborate in a future call more about that.

First the level of interest level of interest the level of.

Understanding and level off.

They today dealing with the cost of surgical site infection. This was clear from the survey we see synonymous.

In depth interviews and the other one.

We think is very important it's worth mentioning.

Do you usually see in those new product sales for the kit for adoption some level of tension between the surgeon the doctors and the hospital administrators, the surgeon and the house that doctors are tending to be more prone to.

Adopt newer to claw nurseries annuity five versus say the pharmacies as if kitchen committees are pushing back and saying well, we don't have the budget for that.

This wasn't the case.

And our next 100, and then dose in this survey, we actually saw equal interest and in some cases, even higher interest lets say an abdominal surgery of the.

The people that are responsible for the budgeting at.

This is a very important pick our spots.

Yeah.

Okay. Thanks for the clarity there. So obviously your pre IMD meeting is coming up. So do you think the FDA might want to see the efficacy of your drug in nonhuman primate.

Also can you comment on the safety and stability profile profile of uncle Flex.

So I'll start with the second pause and maybe it'll clarify a bit what you are saying too in the first part in terms of safety, we now have quite so fast.

The preclinical package on safety.

I think it's worth mentioning that the offer little dose of doses. So when you are administrating. It locally is very very minimal you could even.

It's it's almost 1% of fourth would be Administrated systemically that that's how small the overall dose because it's where it's needed as a target.

The unmet need directly and there is no use of the systemic administration did dilute the drugs. We can have it as an overall small dose and you are asking about our pre IMD meeting this month.

Yes, the pre IMD meeting.

So what what you want to ask about it.

So the question is obviously, you demonstrated efficacy and a rat models and most modern so I'm just curious whether there be it might be they might they want to know the efficacy of the drug in non human primates, meaning large animal models because of the nexus between the non human primates and then predicting.

Oh therapeutic response.

Yeah.

So this is exactly the the visit to conduct a pre I N D meeting and get the feedback on our suggested plan and everything that was already done I mean, we already have robust preclinical package.

We've submitted asking if this is sufficient well need to wait and hear from the FDA before we can comment on that.

Understood.

So along those lines.

Several experts argued that the Muslim wide is a paradigm shifting drug in Glioblastoma treatment. In fact, our studies have shown that it increases the two year survival from 8% in patients with radiotherapy alone to 20% in patients with combined therapy. So is that a reason not to include demos.

In your encore Plex formulation.

So there are many drugs that can be used in.

As a as an agent for all things.

We don't have to stop it there.

It's chemotherapy.

Plex thoughtful and this was demonstrated in some cross research collaboration that we had can also be.

Rising antibodies.

And the specific and really there are numerous opportunities here to start it touched a point in cancer.

Definitely it's not limited to chemotherapy and not to a specific chemotherapy, what we think and what we see today.

The limiting factor with UBS.

The blood brain barrier.

And bypassing this limiting factor can change the efficacy of many drugs.

The reason for choosing those civic sell first because this is a part of the labeling of the drug so it's easier in many aspect to come to the FDA with this but there are other drugs that could also be efficacious, we are very pleased with that.

This we see up until now quickly Nicole.

We are confident that we will continue to see that in clinical studies as well.

Okay.

Yeah.

Thank you. Your next question comes from the line of Elliot Wilbur from Raymond James Please ask your question.

How long did it take hold this.

On behalf of the area.

But I don't see any changes to the secondary endpoint in either of them did trials around marketing related data points based on feedback from payers and providers.

No changes at all we are continuing as planned.

And we haven't changed any of the secondary endpoint or the primary endpoint.

Okay, great. Thank you.

Thank you very much.

Thank you there are no further questions I would like to hand back to EMEA weisberg for any closing remarks.

Thank you for joining our third quarter 2021 earnings conference call.

I would like to say again, how excited we are about the progress we have achieved to date.

Basically in the flex one of the other clinical program as well as the opportunities that lay ahead.

The first well.

We remain grateful to our team members and all are with external partners.

Our commitment to our mission and their support and continuing to advance toward achieving that goal with lingering they flex one.

Encore play to healthcare providers.

Patients with <unk>.

Quickly as possible.

Thank you.

That does conclude our conference for today. Thank you for participating you may now disconnect.

Okay.

[music].

Okay.

[music].

Yeah.

[music].

Okay.

Hum.

Yeah.

[music].

Okay.

[music].

Yeah.

Okay.

[music].

Mhm.

Yeah.

[music].

Okay.

[music].

Okay.

Right.

Great.

[music].

Yes.

Jesus.

Yes.

[music].

Okay.

[music].

Okay.

Yes.

[music].

Okay.

Right.

Yeah.

[music].

Thank you all for participating and Polly P third quarter 2021 earnings conference call joining.

Joining me on the call today will be a mere whites bird chief Executive officer, and deeper trough because OXXO Brian.

Vice President and Chief Financial Officer of Hollywood.

Earlier today.

I would get released financial results for the three months and nine months ended September 32021.

Copy of the press release is available in the investors section of the company's website.

Www Dot <unk> dot com.

I'd like to remind you 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 discusses the expected recruitment for trials.

Timing of trials and results thereof.

The company's manufacturing facilities.

Pipeline.

Benefits of cheap flex 100, and uncle Plex.

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 that could.

Cause actual results or events to materially differ.

Accordingly, you should not place undue reliance on these statements.

I encourage you to review the company's filings with the Securities and Exchange Commission.

Living without limitation, the company's form 20-F, which identified specific factors, which may cause actual results or events to differ materially from those described in the forward looking statements.

<unk> disclaims any intention or obligation, except as required by law to update or revise any financial projections or forward looking statements, whether because of new information future events or otherwise. This conference call contains time sensitive information.

<unk> only as of the wide broadcast today November 10 2021.

With the completion of those prepared remarks, it's my pleasure to turn the call over to Amir Weisberg CEO Amir.

Thank you Bob.

On behalf of our team at Chipotle food I would like to welcome everyone to our first quarter 2021 earnings call.

I will begin today with some brief introductory comments the cloud will provide the detailed business update and then she will review our financial results after which we will open the call for your questions.

We continue to rapidly advance our menu development programs as well as our commercial preparations.

Most importantly, our win large phase III program for our lead also depicts 100 for the prevention of surgical site infections.

So sorry, it's Paul.

Good thing it's Glenn.

Okay.

Necessarily account for around 20% of all hospital acquired infections in the U S, resulting in extended hospital stay and readmission and anything up to $10 billion in annual.

Maybe chemicals.

From a commercial perspective.

Discussed on our last call, we have developed and launched Glenn that's including all the different activities that will accrue from now until launch.

For the various functions.

Including sales and marketing formulary access and medical affairs.

In addition.

<unk> has been developed to permanent hiring needs.

Timing for each of the different functions as well as the infrastructure that will be needed in preparation for launch.

Brain tumor continues to generate compelling preclinical data, which declared will highlight shortly.

Of significance, our R&D meeting.

Meeting.

Wherever we hoped to achieve agreement with the agency on the preclinical and clinical development plans for corporate is scheduled to take place later this month.

Based on our recent accomplishment policy it is well positioned.

Further in clinical and operational success more wherever we continue to operate from a position of financial strength.

We expect that our colon balance sheets will be sufficient to complete the shield one study to conduct two.

Preparing for the submission of the NDA to the FDA as well as further advanced our article clicks development platform.

With that I will now turn the call over to the clock to provide you with some further updates.

On the OE business the clock.

Thank you Amanda and thank you for joining us on the Cogs.

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 continued to increase over the last several months.

And we expect an even greater acceleration in enrollment in the coming months. We now have approximately 480 patients enrolled into this study and based on the current environment. We anticipate that the recruitment rate will increase to 200 to 250 patients.

Good quarter.

As you know during the second quarter of 2021, we received written responses from the FDA regarding our development plan for <unk> 100.

The FDA agreed that our proposal for a single phase III pivotal study.

The study results are adequate would constitute significant evidence of cleaning kind of efficacy to support approval of duplex 100 for the prevention of anthracite and colorectal surgery.

As a reminder, our plan was to enroll up to 900 patients into the study we did 60 centers in the U S EU and Israel.

From a clinical perspective, this will help ensure the chilled one is well powered and will provide additional desktop.

Will potentially be used to further demonstrate the medical and health economic benefits of duplex 100.

We intend to further update investors and analyst on enrollments tattoos wants to 500 patients have been enrolled and then again following the blinded infection rate assessment.

Based on the target enrollment of approximately 900 patients.

We now anticipate the last station to enrolling chilled one will be during the second quarter of 'twenty to 'twenty two.

Do you have any ability of topline data two months thereafter.

Importantly, we believe the potentially significant commercial and pharma co economic benefits of conducting shield one in the Io handle this.

Targeted patient enrollment range.

Oh wait the resulting modest the extended timeline to topline doctor.

From a financial standpoint, because we only need to conduct shield one to potentially receive FDA approval and do not need to ramp involvement in Q2, and then equally robust pace. We now anticipate that our cash runway will be extended to you and 'twenty 'twenty.

You too.

This is an improvement from our prior expectations without cash would find us into the second half of 2022.

As a reminder, approximately 70% of the patients currently enrolled in shield, one habit colorectal cancer diagnosis at rates similar to the 74% seen you know successfully completed phase two trial.

The remaining procedures, primarily consist of dose related to crawling disease and IBD.

Because there's no major safety issues related to deep six 100 have been observed in shield one to date.

Moving onto shield two our second phase III trial in abdominal surgery, which includes brought you alert the PTT criteria, including minimally invasive procedures. This study also continues to progress as planned although our focus remains on opening centers at a measured pace.

Total enrolled patients in shield two is currently over 100 and safety.

In terms of potential collaboration for the future commercialization of flip looks 100 in the U S. We remain in dialogue with several large and midsized pharmaceutical and medical device companies.

That we believe would be ideal commercial partners for duplex 100.

As I said on our last call. These companies are leaders in commercializing pharmaceutical products in medical devices have strongest stablish commercial infrastructures exhibit a detailed understanding of <unk> and pharmacological economic benefits in the hospital channel and.

<unk> strong relationships with the hospital clinical medical and administrative stuff.

Importantly, there continues to be a high level of interest in duplex 100 from these potential partners.

Potential collaboration in Europe and Asia.

Now I'd like to further elaborate on the status of phone conflicts of interest.

Intra tumoral chemotherapy product candidates initially targeting solid tumors, including doses of chemotherapy resistant.

As a reminder, uncle Plex provides local prolonged and controls exposure to dose up excel into intraoperative tumor resection setting as you know <unk> is one of the most widely used chemotherapy agents worldwide.

Brain tumors was selected as the initial indication for uncle Flex.

Because there is currently almost no meaningful cumulative up with each treatment options for brain tumors.

Due to the limited ability of the treatments to penetrate the blood brain barrier due to the localized and prolonged nature of phone complex. We believe it is highly beneficial as compared to systemic treatments.

Well as the currently Evaluable no question.

In these devastating tumors that often cannot be fully resected surgically.

We recently reported additional positive preclinical data in two key glioblastoma multi form or G. P. M animal models, demonstrating that a single local treatment a phone call place.

Significantly inhibited tumor growth and prolonged survival.

In addition, a dose response was demonstrated for own complex.

The different animal models.

These important results further support our work toward the pre IMD meeting with the FDA to potentially initiate a phase one two clinical trial.

And some of you have noted we are pleased that we have the pre IMD meeting scheduled with the FDA for later this month with the objective of coming to agreement on the clinical and non clinical development plan for uncle Plex in GBM.

We remain focused on potentially initiating a phase one two clinical trial of uncle Plex and G. P M in 'twenty to 'twenty two.

And continue to expand our network of top experts and Kols around an uncle Plex development program to support our airports and these promising area.

We did I will now review our recent financial results.

Cash used in operations for the three months ended September 32021 totaled $10 million.

Now, let's turn to our income statement.

Research and development expenses for the three months ended September 32021 were $7 $3 million compared to $4 $2 million in the same three months period of 2020 the.

The increase in research and development expenses resulted from the increased cost and activities related to the ongoing shield, one and shield two phase III clinical trials and abdominal surgery.

Marketing and business development expenses for the three months of 2021 with $400000 compared to 300000 for the same period of 2020.

General and administrative expenses for the third quarter of 'twenty or 'twenty, one with 2.1 million consistent with $2 2 million in the prior year period.

For the third quarter of 2021, the company had a net loss attributable to ordinary shares of $9 $9 million as compared to six 5 million in the prior year period.

We will now open the call to your questions operator.

Thank you.

A reminder to ask a question you will need to press star one on your telephone to withdraw your question. Please press the pound key system by while we compile the Q&A roster.

Okay.

Yes.

Yeah.

Your first question comes from the line of Gary Nachman from B and capital markets. Please ask your question.

Hey, guys good morning, and nice to see all the progress first with the decision to go to the higher end of the target enrollment range for shield. One you havent done the sample size re estimation, yet so could the target number of change depending on that re estimation in the results that you got from that.

And then the other piece that you need a you said that glad to get to 900. Some before 80 currently are in the second quarter or are you factoring any potential headwinds from Covid. If there is.

There are surgeons, how locked in do you think that that timeframe is and then I have a couple of months.

Yeah.

So first good morning, and thank you for that maybe to better explain our differentiation regarding the.

900 patient, we should remember that when we designed the trial and when we started we were under the understanding with the FDA that we need to phase III trial in order to get an M. D. M D.

During this process, we received the breakthrough therapy, which essentially said, we only we got an agreement with the FDA. Just one trial is sufficient and we that as we started to progress we understand that we are going to go through the approval and the marketing stage with only one trial.

And the second one will totally be modified to a smaller number and there is no need to do to fully pivotal studies. If you are not requested too and we wanted to make sure that we have in addition of course to the.

Secrecy.

Every endpoint, we have sufficient health economic data and marketing that time. This was this decision the 500.

Just a week.

Even days in terms of reaching the last patient to 500 as we are now in approximately 400 in Asia and as we said.

Earlier.

Yeah, and the formal Cogs, we do intend to investor.

They are not expected to change.

This is our expectation is that this is this will be the number.

Oh, there is something we always have the.

Yeah.

As part of their charter and ability to stop as early as Q2 overwhelming result, but it's too early to look at that.

With regards to the pace of enrollment if you look more in the an overview look you can see that during the second quarter, we recruited 100 patient.

During the third quarter, we were.

Of course at 180.

And now we are comfortable saying that we expect that this will be.

Getting to the top of funnel expectation, which is a $2 250 patients per quarter. So starting from a point to a full accurate and 18th patient that we have now you could very easily see how we get to the second quarter with the last really the last page.

Yes.

Okay. That's helpful and then.

Just a little bit more on the type of partnership discussions that you're having it sounds like it's across all regions, but that you're still planning on commercializing on your own in the U S. Do you know when that you hired someone to potentially help your plan that so I guess I'm just a little confused if you think you will end up.

<unk> in the U S, where you'll find a partner.

Or if that partnership will likely.

More likely be outside the U S.

So the partnership I'll separate for a second just to remind everyone. Our plan in the U S is to have at what Salvador itself.

Strategic cooperation so on one hand, we do want to have a boots on the ground and have some level of presence. This is the main market. We do want to have some presence and putting the plan in place doesn't mean that everything in this plan will be executed by Oh now on it could be somewhat positive.

The execution, but also some of it when we do sign a partnership will be executed with a partner. The idea is to have a strategic partner. Our thinking is that this will probably be signed after we have the data into the U S. With regard to Europe, we are in discussion.

More than evaluating the partners and keeping them.

It's updated to where we are and this could fairly in Europe, and Asia and the rest of the world. We do look for licensing agreements those are things that are in discussion.

And of course it is.

It's something we can put a timeline on it.

Yeah.

But even though our licensing outside the U S will likely come after the data.

It's hard to say, it's hard for us to say it depends.

There there is a point.

The discussions where data is just around the corner.

It won't be the case, but it's hard for us to say at this stage.

Yeah.

Okay, Alright, great and then just lastly on uncle Flex do you have a sense of what the phase one two study in <unk>.

<unk> might look like.

You're going to have to create and meeting with FDA, but going in and I'm assuming that you have an idea. So is that something you can talk about at this point, maybe even just.

Size or any.

Any other parts of the protocol.

So we do have a status because the the meeting with the FDA as we said is six months and we've already submitted the fact that I think it's best to get the feedback and see if everything that we've suggested in terms of the.

Preclinical and clinical development plan.

Align with what the agencies and then we can get them on to more detail on that but.

Let's let's forgive the SBA debt.

To be the first to react to that and gave us the comment.

Okay I won't be insulted.

Alright, Thank you very much thank you.

Thank you Gary.

Your next question comes from the line of from didn't Folkes from Cantor Fitzgerald. Please ask your question.

Hi, Thanks, taking my questions and congratulations on all the progress.

Okay cool down a little bit more on the cash runway and understood.

Understanding how are we going to go to the high end of the range and patient from Q1.

And I did hear your commentary on that and reducing the overall number of patients potentially in Q2, but should.

Should we think about Q2 timelines, maybe being pushed out somewhat.

And then you know.

Maybe just any color in terms of how you're thinking of the bridge from colorectal to a broader label.

Yeah, That'd just be helpful. Thank you.

So youre right.

First of all thank you Brandon for the question because we don't want to give some clarity on that we are evaluating.

How best to pursue shield.

Two and obviously.

The FDA recognizing that one pivotal trial is sufficient we do not need to have shield two in such a robust.

Syed.

Chose two does have the cultural legibility criteria that can help us broadening the indication.

This is something that will be updated as we go and get closer to topline results, which showed one this is not something that we will do it now, but we do understand and.

With this.

Glad to have knowledge like Bob.

We do not need to have shield two as such a large size, so obviously and.

We will need to invest less in shield two in order to bridge the.

Fortunately it appears.

Our uniform.

Okay.

Oh I see.

Yeah.

No.

Okay.

That's not just us.

That's right.

Yes.

[laughter], Yeah, no I'm aware of.

Okay.

[laughter], maybe could I just ask a follow up here and.

I understand you're probably not going to comment on it but we have seen another company within a different division in the F. D. A.

Came out recently and they go to a narrower label on approval and it's in the hospital within the play surgical environment for the product.

They came out onto the commentary that the FDA has just asked them to collect additional data on our guests a wider.

Variety of procedures, but really not off people efficacy data in those procedures and really just looking at PK PD.

Is that anything you're willing to comment on at the moment.

So I cant really comment because this is something you know we will need to discuss with the FDA, but we are looking at it.

This is from our perspective and also looking at other product in the surgery suites.

It's very in line of what we see.

And we think that in the.

Both the mechanism of action of our eclipsed 100 as well as the area that we are with the flex 100, and anti infective product.

And the breakthrough therapy, all these parameters together within Cogs in our in our favor, but this will need to be discussed with the FDA.

When we have there.

The end of Phase II meeting.

Great. Thank you very much I appreciate all the color and congrats on the progress.

Thank you.

Yeah.

Okay.

Your next question comes from the line of balance sheet philosophy Prasad from Barclays. Please ask your question.

Oh, Hello run so again, so I Didnt mentioned is going to see the progress and are you getting there.

Hum.

Couple of questions on one on the expense side can you.

<unk> signed was a spinoff expenses between shield one unchanged too.

And secondly, with regard to your partnership discussions and as it evolves with with the with the progress in enrollment are there any new learnings that you are getting from your partnership discussions made on the commercial side of the clinical positioning and anything else.

So before I relate to the second part could you repeat the first part of your question.

Yeah, absolutely what I mentioned was and it's great to see that then also cause signals in shield one.

Whats the latest expenses between shield why don't you do currently.

Sure. So in general I can tell you that.

They were supposed to cost more or less the same.

In terms of that we had talked we were talking about a $20 million to $25 million the cost of each phase III.

So you could ask.

Separate from that what what could be the same thing we are not stopping showed two of course, and we do want to pursue it but we will be modifying it now that we don't need it.

As a pivotal but more as a.

Phase four trials.

It could be reduced in terms of the number of patient. It's a required with regard to the second question about feedback.

I can tell just a bit of color of what we see for <unk>.

We are.

Very pleased with the level of interest.

And we see that the interest is not.

Limited too.

Specifically, all grocery, but it's worthwhile and we are also.

Very happy to get some insight on the unmet need in these different geographies.

This is something that's from our perspective is encouraging.

We see both the interest and the unmet need and.

The cost of it today to the different hospitals and the different health care.

And in different countries and this is very encouraging in all right.

Well thank you.

Yeah.

Your next question comes from the line of Louise who kind of from JMP Securities. Please ask your question.

Alright, great. Thanks for taking the questions I guess the first one on shiel to maybe this is a moot point because it sounds like you're.

Got to resize the trial, but just curious if you're also seeing enrollment rates increase.

<unk> two is as you see it in shield one.

Yeah.

So we first of all our basic assumption was that recruitment and shoot to will be faster because it's it has apologised legibility criteria and then the few centers that are opened since we started this trial, we see that we see that is that.

Potentially a trial that will be easier to recruit because of the poetry relates ability criteria, but as we said in our formal part we are still at the stage of opening the center so as opposed to.

She was one where we have approximately 60 centers that are opened.

This is not the case yet in Q2 and now that we are fully focused in shield one and this is a pivotal trial for approval we can valid.

Same cast off expenses, and one way and make sure that we are having shield two and October.

And the upside that is required for just a broadening the indication and having it as a phase four as opposed to chilled water, which is a phase III.

Okay.

Great and then I wanted to dig in a little bit on something you said about.

Shield, one so you're still conducting the interim analysis on infection rates set at 500 patients and I don't think you plan to announce the infection rate, but can you just.

Confirm that and then the.

Comment you made about the DSM be looking at the.

Potential overwhelming efficacy, but it's it's too early is that does that mean that they haven't looked for efficacy just because you don't have enough patients or they've looked and you don't expect to see anything because there aren't enough patients or what's the plan at 500 patients so you're going to potentially.

Potential to stop the trial at that point. Thanks.

So first of all.

To be clear the 500 patient is not all that interim analysis.

So everyone is blinded to it it's not something that we don't open the.

The data at this stage, it's and over look I have two the data without blinding. It. So it's not a real understanding of the efficacy and yes, we will not be able to share the infection rate since its as we said its blinded but it is.

It gave us a reassurance into the fact that we are on track and that the number of patient could get us to this point that that we are hoping for with regards to the DSA business.

Very sad to see Smb's charter do have the ability to stop the trial based on overwhelming resolve this is not something that is unique to our oh.

They have to have the level of safety that is required before they can even look at it and in our case. This was a minimum of 600 patients 616, if you want to be precise. So when I was saying this is too early that means that.

We are not aware if they looks like they are not of course, it's still something that there is no dialogue between us and debuted somebody but once we this is part of their charter to look at it.

First you need to have the minimum patient in terms of safety.

Got it okay, great. That's helpful. Thanks, and then on the Hum.

On the cash runway.

How does the ATM contributed.

To that at all it doesn't look like you did in <unk>, just looking at the share count.

Reported but have you used it since the end of the quarter. Thanks.

So this is not something that we are going to update them, except for of course, the financial and as you mentioned, it's obvious that we haven't used it we did say that we are not going to use. It. This is twice what we saw in the quarter and we see.

No need for that especially now with that sharing with investors that we have extended our cash runway into the angles next year, there's no need.

We use this tool and this level of share class.

Okay. Thanks for taking the questions.

Thanks you.

Your next question comes from the line of Jim Molloy from a G. P. Please ask your question.

Hey, guys. Good evening. Thank you for taking my questions I had a quick question on the.

On the <unk> I know, we've touched upon and obviously its a less urgency now what is the ultimate ultimate goal on the on the shield two.

<unk> shield two on running that now that it's not a priority mission critical for NDA filing.

Run is the safety of what's the what's the thinking on sort of running out.

<unk> T trial at this point.

So the show to I have two.

Two objectives. One of course is safety and the second one is to have a bunch of eligibility criteria to broader indications.

Mainly to minimally invasive.

Shield one.

Focused on open procedures is mainly focused on open procedure and shield two will give us the ability to broaden the indications.

Many of an invasive and we are looking also if we will need to have some a small portion of the additional abdominal surgeries.

Without different dialogue with the agency in the European and the FDA is not necessarily the case because correct Rick.

Resection.

<unk>.

So we took the worst case in abdominal surgery tenths of that level of infection there.

We're looking at a double digit infection rate in U S and open up the Ohio procedures. So we this is that the worst case of Domino surgery into the surgical site infection.

Okay.

And what's your thinking on on Q3.

The expansion of the bone tissue to stardom surgeries.

Or does it sort of stand and whats <unk>.

<unk> seen there.

Yes.

As we said this will be something that we will only.

And initiated after we have the topline results.

Chosen why and have our discussions with the FDA on that at the end of phase II meeting and on the labeling.

No.

Yeah.

And then maybe last question on on complex.

Any thoughts on Docetaxel, the migration from sort of the application side.

I was wondering are you looking at any thoughts on what you anticipate there.

Can you repeat the question Jim sure looking at the uncle Plex trial, the local application of Docetaxel.

Any thoughts on you know.

Confidence on keeping the dose tax from migrating from sort of the local applications and obviously the whole idea would be you use it locally rather systemically.

Sure so.

Yeah.

Thank you for that that's from our perspective. This is what we believe is D.

Added the value of our flex platform.

Our ability to the combination of two ability is the ability to.

B anchored locally to be locally and stay locally.

As well as having prolonged local delivery.

And also looking in some other local cumulative outgrew ASIC agent in the G. P. M Arena, we believe that this is why.

Our complex could bring.

Central and because of its ability because of the size of the drugs that the 100 micron and its not migrating from the site the site of application that children residual side.

Combined with a prolonged exposure this can potentially cover all the area off the residual tumor site.

Okay.

Yeah.

Thank you for taking the questions.

Okay.

Well it kind of if you wish to ask a question. Please press star one on your telephone.

Your next question comes from the line of Rob Cellphone machines from H C. Wainwright. Please ask your question.

Hi, This is Bob Allen dialing in for Ron Suraj, you and thanks for taking my question. So firstly have you done any physician based market research and payer research consulting duplex 100 commercialization. If so can you share some key takeaways.

Sure so and so we have done a very robust study.

Some of which we've already we haven't actually done two but one more recently into a viewing 18.

Hum.

Stakeholders.

Half of it being a.

Jeff Domino surgery, cardiovascular search engine orthopedic surgeon and the other half being hospital administrator is privacy.

He comes to.

And I think that they are ready to take out of it but there's two there too from <unk>.

Our perspective, maybe worth mentioning and we can elaborate in a future call more about that is first the level of interest level of interest the level of.

Understanding and level off.

They today dealing with the cost of surgical site infection. This was clear from the server system.

The surveys in depth interviews and the other one that we think is very important is worth mentioning here.

You usually see in dose.

Product sales for the kit for adoption some level of tension between the surgeon the doctors and the hospital administrators the subject in the house that doctors are tending to be more prone to adopt new to claw that Gs annuity.

<unk> versus say the pharmacies at the PT committees are pushing back and saying well, we don't have the budget for that.

This wasn't the case.

And our next 100 and then don't in this survey, we actually saw equal interest and in some cases, even higher interest lets say an abdominal surgery of the.

The people that are responsible for the budgeting.

This is a very important pick our spot.

Okay.

Yes.

Okay. Thanks for the clarity there. So obviously your pre IMD meeting is coming up. So do you think the FDA might want to see the efficacy of our drug in nonhuman primate.

Also can you comment on the safety and stability profile profile of uncle Flex.

So I'll start with the second pause and maybe it will clarify a bit what you are referring to in the first Bob in terms of safety, we now have quite robust.

In pre clinical package on safety.

I think it's worth mentioning that the offer little dose of tough with excel. When you are administrating. It locally is very very minimal if any.

And.

It's it's almost 1% of fourth would be Administrated systemically that that's how small the overall dose because it's where it's needed as a target.

The unmet need direct and there was no use of the systemic administration that dilute the drug we can have it as an overall small dose and you are asking about our pre IMD meeting this month.

Yes, the pre NDA meeting.

So what what you want to ask about it.

So the question is obviously you demonstrated efficacy in a rat models and most modern so I'm just curious whether that'd be it might be.

Want to know the efficacy of the drug in non human primates. Many large animal models because of the nexus between the non human primate.

Predicting human therapeutic response.

So this is exactly the theyre the visit to conduct a pre IND meeting and get the feedback on our suggested plan and everything that was already done I mean, we already have robust preclinical package.

We've submitted asking if there's sufficient well need to wait and hear from the FDA before we can comment on that.

Understood.

So along those lines.

Several experts argued that demo Zola mine is a paradigm shifting drug in glioblastoma treatment.

Fact, Ah study shows zone shown that it increases the two year survival from 8% in patients with radiotherapy alone to 20% in patients with combined therapy. So is that a reason not to include that most all of them either in your own Kool Plex formulation.

So there are many drugs that can be used in.

As a as an agent for all things.

And we don't have to stop it there.

It's chemotherapy.

<unk> block four and this was demonstrated in some cross research collaboration that we had can also be.

Rising antibodies and be specific and really there are numerous opportunities here to start I've touched upon it in cancer.

Definitely it's not limited to chemotherapy and not to a specific chemotherapy.

What we think and what we see today.

The limiting factor with UBS.

The blood brain barrier.

And bypassing the limiting factor.

Change the efficacy of many drugs.

The reason for choosing Bill Stith himself first because this is a part of the labeling of the drug so it's easier in many aspect to come to the F. D. A with this but there are other drugs that could also be efficacious. We are very pleased with the depth of this.

C up until now quickly Nicole.

We are confident that we will continue to see that in clinical studies as well.

Yeah.

Thank you. Your next question comes from the line of Elliot Wilbur from Raymond James Please ask your question.

Yeah.

Hello, Paul.

On behalf of the call.

I don't see any change in the secondary endpoint in either of the trials around marketing related data points based on feedback from payers and providers.

Yeah.

No changes at all we are continuing as planned.

And we haven't changed any of the secondary end point or the primary endpoint.

Okay, great. Thank you.

Thank you very much.

Thank you there are no further questions. So I would like to hand back to EMEA weisberg for any closing remarks.

Thank you for joining go with third quarter 2021 earnings conference call.

I would like to say again, how we're excited about the progress we have achieved to date.

Actually in the Flex 100 clinical program as well as the opportunities that lay ahead.

Trust.

We remain grateful to our team members and all are with external partners.

<unk> commitment to our mission and their support and continuing to advance toward achieving that goal with lingering effects.

Encore blakes to healthcare providers and patients as quickly as possible.

Thank you.

Q3 2021 PolyPid Ltd Earnings Call

Request a DemoDemo

PYPD

PolyPid

Earnings