Q1 2022 PolyPid Ltd Earnings Call

May 11, 2022

[music].

Greetings and welcome to the Poly Pizza first quarter 2022 conference calls.

This time.

Listen only mode. As a reminder, this call is recorded and I would now like to introduce your host for today's conference both Judy from Life Science Advisors.

You may begin.

Thank you all for participating in <unk> first quarter 2022 conference call joining me on the call today will be a mere weisberg chief Executive officer.

Glad Tchotchke OXXO, Bryan Executive Vice President and Chief Financial Officer, RVP, and or where Sharpie, Chief operating officer for Poly Pizza U S operation.

Earlier today the company released financial results for the three months ended March 31 2022.

A 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 bet on this call match won't make forward looking statements within the meeting.

Federal Securities Laws for example management is making forward looking statements when it discusses the conditions for the drawdown of the second and third tranches of the cruise capital alone.

The loan agreement broadens, the company's financing options and provide them with.

Access on a non dilutive basis, two significant additional capital.

Companys pipeline expected benefits from recent executive appointments, the expected timing and our recruitment for trials the interim data analysis.

Timing.

The release of its results and the potential implications.

<unk>.

Forward looking statements include future commercialization of the company's products.

Potential use and benefits of duplex 100, and complex market opportunity for duplex 100.

U S addressable market for duplex 100, it's ongoing pre commercialization preparations and prelaunch activities.

The company's potential partners additional.

Publications and presentations at important scientific conferences.

And sufficiency of.

The company's cash to fund future operations into the second quarter of 2023.

Forward looking statements are subject to numerous risks and uncertainties many of which are beyond our control, including the risks 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 SEC.

Clothing without limitation, the Companys form 20-F.

Which identify specific factors, which may cause actual results.

Or events to differ materially from those described in the forward looking statements.

Hey, Pete described disclaims any intention or obligation except as required by law.

Date, 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 and speaks only as of the live broadcast today May 11 2022.

A copy of the slide the management team will review on this call can be found under the investors section of the company's website at <unk>.

Investors, how IP dot com.

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

<unk>.

Mirror.

Thank you Barbara.

On behalf of our team at <unk> I would like to welcome everyone to our first quarter of 2022 earnings call.

As this will be my final earnings conference call as a CEO I would like to take this opportunity to thank the board and our shareholder for Denso bolt and confidence in allowing me to serve as the CEO of fully paid for over 11 years.

I am also grateful to all of my colleague at <unk> for their hard work.

And commitment during this development stage, which allow us to accomplish much over the years.

Political is no a position of strength clinically operationally and financially.

As we advanced with our phase III trial and.

Neil potential monetization. It is current time to declare to lead the company into its next phase of growth. Therefore once again.

I would like to.

The clock on his well deserved appointment as the CEO , which will become effective July 1st.

Since joining quality it seven years ago. The cloud has been key guiding the company towards our objectives as a shareholder.

<unk>.

Other shareholders on this call.

I look forward to the DMC recommendation on our shield one trial once the interim data on 750 patients is fully annualized.

And two the continuing development of our promising pipeline corridor kind of did that on complex for the treatment of solid tumors.

With that I will now turn the call over to the clock to provide a detailed update including a discussion of upcoming key milestones and a review of our financial results. Following disease. She will open the call for your questions.

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

On behalf of the entire policy team. Thank you for your leadership over the past 11 years.

Guidance has been invaluable to me as we have prepared for the upcoming CEO transition.

Over the last several months next.

Next slide please.

With that I will begin by providing a brief update on the status of our pipeline.

First we remain extremely pleased with the rate of involvement in shield one.

Phase III study evaluating duplex 100 for the convention Domino soft tissue surgical site infection or exercise.

Now have approximately 900 patient enrolled into the study across about 60 centers, the United States Europe and Israel.

Importantly, you will recall from our first quarter announcement that the FDA agreed to policies to be quick.

With the addition of an unblinded interim analysis and shipped.

Our request was based on the Fda's recently published guidance for pharmaceutical companies to address the impact of COVID-19 on <unk>.

We think enrollment study objectives for clinical trials conducted during the ongoing pandemic.

Analysis is expected to occur.

Shortly.

750 patients complete their 30 day follow up.

Statistical analysis has concluded.

Which will allow for early trial stoping due to efficacy facility offer sample size reassessment.

Now, let's talk to the trials can occur if the efficacy results on the exercise of it exceed expectation.

As we said on our last call. This interim analysis is an exceptional opportunity for quality to more precisely defined targeted patient enrollment range for the shield, one study and the timeline for NDA submission.

As a reminder, the 750 patient was enrolled into shield one in early March 2022.

Next slide please before I move on from the development program for <unk> 100, I would like to remind you that one of the key priority in 2022.

As discussed on our last call was a focus on building the significant body of evidence in support of the safety and efficacy of this promising product candidates throughout peer reviewed publication in Dhaka presentation at important medical meeting.

To this end, we recently presented positive clinical data on <unk> 100 from our phase II clinical trial at both stages 2022 conference and the surgical infection Society 2022 annualized.

Before we continue to discuss politics financial.

Our activities to strengthen our commercial readiness.

Enhanced clinical development function, all we will give some color on market opportunities for <unk> 100, our ongoing pre commercialization preparation and potential partnership in the U S Army.

Thank you decline.

Next slide please.

In the U S. We believe the total addressable market for duplex 100 is just over 12 million surgeries per year based on IQ via data the leading industry source on procedure in prescription data.

There are approximately $4 4 million abdominal soft tissue surgeries annually, both open and minimally invasive procedures.

Simply comprised of hernia repair.

<unk> and colorectal surgeries.

We also believe that there is an opportunity for the use of duplex 100 in an additional $2 1 million abdominal procedures, principally in gynecology, and urology, including hysterectomy and other related procedures.

Other duplex 100 relevant surgeries, which either have high ssi rate or our high risk surgeries include two anatomies joint replacements and vascular surgeries.

As part of our prelaunch activities, we examined pricing in the range of 200 to $600 per vial was tested in market research in line with other local therapies used in the surgery suite.

Such as EXPAREL and the stimulus.

Moreover, we are doing additional diligence to annualized pricing requirements for duplex 100 to qualify for additional reimbursement when used in inpatient and outpatient settings, which would facilitate more rapid uptake of our drug by health care facilities.

From an execution standpoint, we are advancing our go to market plan, which includes the patient and surgeon journey.

Finding our differentiation levers value drivers and a tactical plan for launch we are also making significant efforts in the medical affairs area, including Onboarding, a number of key opinion leaders as well as planning for additional publications and presentations at important center.

Conferences.

Finally on the business development front, we continue our discussions with potential partners for the U S as well as ex U S with companies with established presence in the hospitals and number of them with established surgeon and surgery focused sales team.

And with that I will hand, the call over back to the cloud.

Sure.

Thank you.

Next slide please we continue to strengthen our management team with the recent appointment of <unk> as the company's new EVP of operations and the promotion of <unk> to EVP research and development clinical and regulatory affairs.

We believe <unk> will meaningfully enhance our technical operations and delete will have an expanded positive impact on our clinical development initiative.

Jenny will lead technical operation for quality, including including manufacturing engineering supply chain logistics and quality.

Is it expert expertise span FDA approval pre requisite operational optimization supply chain management and sterile pharmaceutical manufacturing.

<unk> has said its policy senior Vice President Research and development and regulatory Affairs since June 2021.

Has been with the company since 2016.

<unk> of increasing responsibility.

As executive Vice President heading R&D and clinical and regulatory affairs is the recognition of an important contribution to public.

Next slide please.

From the perspective of our balance sheet, we have made excellent progress over the last quarter.

We were pleased to recently uptake and up to $15 million non dilutive secured term loans.

This agreement broadens, our financing options and provide us with access on a non dilutive basis to significant additional capital, which strengthens our ability to invest in our collection capabilities, but it looks 100 as well as fund future advancement of our unique flex technology.

Paul.

The loan facility is comprised of three tranches in the amount of $10 million, $2 5 million and $2 $5 million respectively.

First tranche of $10 million was drawn in April 2022, the second tranche of $2 $5 million will it be evaluable subjects to abstain.

Positive results from the planned on blinded interim analysis of shield one.

Drawing down of the third and final tranche of $2 $5 million will be a valuable subject to obtaining positive topline results from the shield one trial or other conditions government drawdowns of the second and third tranche can potentially be made.

End of this year.

Also as it relates to our balance sheet during the first quarter of 2022.

So the proximity odd million dollar worth of ordinary shares.

At the market facility or ATM.

This action combined with the loan agreement with <unk> capital extended our cash runway into the second quarter of 2020.

As of March 31st 2022, the company had cash cash equivalents and short term deposits.

<unk>, two <unk> $3 $6 million.

Excluding the first tranche of $10 million of <unk>.

<unk> loan, which was drawn in April 2022.

Next slide please.

Now, let's turn to our income statement.

Research and development expenses for the three months ended March 31st 2022 eight.

$8 7 million.

Two 6 million in the same three month period.

In 'twenty one.

The increase in R&D expenses resulted primarily from the increased cost and activities related to the extent expedited.

<unk> in the ongoing shield, one phase III clinical trials in soft tissue abdominal surgery.

Marketing and business development expenses for the first quarter 2022.

Proxy.

Sure.

Okay.

Just one more question please.

Yes.

Hi, everyone. It looks like we have.

Technical problems, so give us just one one or two more minutes to fix it.

Well it is slightly higher than the $2 1 million recorded in the prior year period.

For the first quarter of 2022, the company had a loss of $11 9 million as compared to $8 $7 million in the prior year period. This was primarily driven by a strong rate of patient recruitment.

One phase III clinical trial.

We will now open the call to your question.

Operator.

Thank you we will now begin the question and answer session.

If you wish to ask a question.

Please press star one on your telephone keypad. Once again, please press star one if you wish to ask a question.

The next question comes from the line of <unk> Prasad from Barclays. Please go ahead.

Okay.

Hi.

Good morning, just.

Couple from me firstly.

You asked about.

Excuse me.

You will see that used case in an outpatient setting for the for duplex.

<unk> called out closeout in his remarks, and an extension of that.

Trial readouts be sufficient for approval in an outpatient setting or if not what are the requirements from a development perspective.

<unk>, probably also Valerie maybe could you offer some more insights into how the U S partnership conversations are evolving maybe.

Maybe the key demands of Goldman from potential partners and what Youre looking point upon those thanks.

Okay.

Alright.

Go ahead. Thank you the first part.

I'll take the first one.

I'll take the first one and then take.

The next one thank you Bob so on the.

Yes.

Outpatient piece.

We're looking at.

Yes.

Surgeries that are done within the hospital outpatient.

It is not at least at this stage not.

The Standalone ambulatory centers. These are surgeries that are done.

Within call it within the 23 hour hour off before before patients become an inpatient surgery.

<unk>.

And most of these surgeries not all but most of them have have an outpatient.

Our patient base and inpatient days for coal for example, some of the <unk>.

Hernia repair.

Major open ones are impatient, but some of the smaller ones.

More minimal invasive ones will be considered.

Outpatient there is still done within the hospital that is done with.

By the same surgeon, it's more of a question.

Of the reimbursement its a question of risk and the question of reimbursement. So if it's a.

More higher risk patients, whether it's older patients maybe a high BMI patients the doctor will will decide on.

On the on an inpatient surgery versus the more healthy patient with the.

The Doctor will decide of doing.

Quicker quicker to discharge surgery.

From from the product from the risk of at this time, there is still a risk the risk is.

Different between ne and open surgery to minimally invasive but there is still exist.

As a reminder, we are talking about the prevention here. So there is.

Colin insurance regardless.

Insurance sales were all types.

Try to create to prevent the infection, whether its nols.

There will be a question on payments for inpatient versus outpatient and this is something that we are looking into in terms of in terms of a pass through and getting close to your code for outpatient payments.

Thank you.

For your second question regarding the discussions the partnering discussions that we have so we are in active.

<unk> engaged multiple pharmaceutical and medical device with medical device companies, both in the U S and out of U S.

Happy with the level of discussion, we expect that those will be accelerated once we have the interim data.

And there is not much that we could say at this stage beside that we are actively engage and quite happy with the discussion.

Thanks, and good luck.

Thank you. Thank you Vanessa and good morning.

Thank you.

Your next question comes from the line of Elliot Wilbur from Raymond James. Please go ahead.

Hey, guys. Good morning, this is actually Michael <unk> on for Elliot.

So first question for me just assuming a positive readout from the interim analysis for <unk>.

Do you guys expect to see further FDA input before submission of the NDA or do you think that the efficacy data would largely be able to speak for itself in the submission process.

And then second one for me.

You might have touched on this in prepared comments apologies if I missed it but just any update on the IMD process for duplex. Thank you.

Sure sure. Good morning, So we do expect to meet the FDA for an end of phase III meeting, we think that this.

Actually with the breakthrough therapy designation that we have this could be an opportunity for us to discuss some aspects of the NDA with the FDA and make sure what we submit on a rolling submission basis.

Later on during 2020 fee is.

Expect excepted.

And there is no need to add any information. Please could also be an opening and open to a discussion on.

The next stage of.

Commercialization and broadening the labeling so we do expect to meet the FDA. After the topline result, as for the Encore Flex program. We're very pleased with where we are there of course, it's a younger program and it's less of a priority at this stage compared to this.

Large phase III 900 patient phase III.

We've published some nice data we met the FDA for pre IMD meeting a few months ago I expect that we will be able to publish additional data supporting conference we talked.

Talking also discussions here.

<unk>.

Pharma companies around the platform as well as the product itself.

I expect we will be able to update you on more specific timelines and indication and project call towards the end of the year.

Got it that's helpful. Thank you and best of luck with the CEO transition and congrats on a year for the retirement.

Thank you. Thank you for both of Us.

Thank you next question comes from the line of Gary Nachman from BMO capital markets. Please go ahead.

Hi, good morning, and congrats on the progress.

So regarding the interim analysis for shield, one what does it mean efficacy better than expected in order to stop it early what's the threshold for that.

And then if you need more patients what's the maximum number you can add and how long would that take.

And will you take a statistical hit on the Unblinded analysis, what did you agree with FDA on that.

Hi, Good morning, guys. Thank you for all of these point.

And please excuse me if I missed any of the three of them. So in terms of.

What does it mean better than expected of secrecy.

No that in all of our ladies on site today, who have shown at least 50%.

Most in all of them more than 50% reduction of infection. So this is what we are hoping to see.

In terms of better than and it is now that 51 will be an overwhelming at this stage, but some where you did not disclose on what is the power of <unk> that will allow us to do.

Overwhelming result.

The reason for that is that we conjecture dicey blinding. This way of course, when everything is unblinded, we could share that as long as we are recruiting patients we cannot be more specific than that and this is quite amazing for this trap.

Regards to the what is the maximum.

We could go after and this is something that we've indicated.

I'll report the maximum that we can see under this protocol.

The sample size adjustment could be 1400 patient overall.

And last question was about the statistical.

This was a minimum of statistical Heath I think the overall instead of 5% we went down to $12 one, but let me let me go back to you on that in more particular, but it was.

So something in that regard.

Okay and then if you have to go up to the 1400, let's say how long would that take.

And also.

60 sites that enrolled the 900 patients.

How comfortable are you with the quality control.

These sites and their ability to measure the endpoint accurately.

Especially considering all the dynamics with Covid.

Sure sure. So I'll start with the second part of the question because here, we have the process to get to the 60 centers.

And you know as well as we do.

Part of it due to covet. It took time to go to come to the position that we have 60 active centers.

For about two quarters, we have it and we see.

<unk> rate of two to 250 patient we added to this call. Some slide at Investor can see how this graph grew along the year and it's very nice to see and we are now constantly.

Now for almost two quarters Rick.

<unk> about 2% to 250 patient.

So we had the time to build the processes for that and we also have the privilege.

That we have adjudication committee that is reviewing each infection case, which is what we need those are the cases that are measured for the primary endpoint.

So it's not the whole 750 patients that are now being analyzed for the interim.

Does that influence the primary endpoint, but we're very comfortable we have a very good team here.

In our clinical department.

Really bringing years of experience in large trial and in a small trial and in different type of.

Medication. So we are comfortable with that and remind me what was the second part about.

Oh no just.

The quality control at the site with Coke and just in general yes.

So we are very happy with that and for now I can tell you that in terms of the recruitment now we do not see it.

For the last six months, we do not see any.

Any problem with it I think you're also asking what will if we have to go to the maximum of what will it mean in terms of time line. So we expect again you could do the math very easily at a rate of 200 150 patients.

Additional few months I'll conclude mint.

Yes.

I assume that you answered that question. So that's helpful and then.

And just lastly, just whats the status of shield two.

I guess does that put on hold until completion of shield one have you been enrolling any patients.

And that study and maybe for Ori.

Just how important shield two is with commercial.

This is <unk>.

Just some of the numbers that you've talked about the fact that thats, including more minimally invasive procedures.

How much would you need that data to hit some of the targets that you are talking about.

So in terms of share too.

<unk> reported in the previous quarter, we already recruited over 200 patients and yes, we did put it currently on a reduced activity until we will have results from the planned shared one because as you remember we said that the road with the understanding that we will need two phase III for approval.

And following the breakthrough therapy designation, the FDA agreed that one phase III sufficient so of course on the basis of positive data from <unk>, we will like to.

Strategically changed some of the perimeter on show to not necessarily the minimally invasive compound debate, but of course, we will not need additional 900 patients. So it could be reduced and this is the plan and this will be part of the discussions with the FDA.

Okay.

Or you want to relate to the aspect of the minimally invasive.

Yes, So hi, Gary So first I would say that for four launch.

With less need they still don't just from the fact and with kind of a recent conversations with with surgeons, we expect that start to work out with the more high risk patients which are usually.

Inpatient open open surgery.

But definitely as we as we look to expand as we look to expand into minimally invasive into the outpatient into.

We.

Into additional surgeries beyond that beyond the initial scope, we will need data should one issued two is part of this.

But we are also working already on one what else is needed what other other smaller studies not necessarily full blown clinical trials, but the.

Whether it's a investigator initiated research or some other settings partnering with some of the societies to see to see what else can we do what type of data will will be needed for.

Successful adoption.

Okay, Great. That's helpful. Thank you.

Thank you next question comes from the line of Brandon Folkes from Cantor Fitzgerald. Please go ahead.

Hi, Thanks for taking my questions and congratulations on all the success over the last 11 years.

Kieran.

The best look forward to taking other form.

So maybe just two from me sort of following on.

The earlier line of questioning.

Can you just provide some detail in terms of what level of data you expect to provide when you do.

Publicly released.

Interim analysis, and then secondly, assuming it's positive how do you think the FDA is going to look at the patients who have already enrolled in the trial just given you.

You have met the 900, how do you think the FDA is going to look at those additional patients. Thank you.

Well.

I'll ask you what do you mean by additional patient.

But in effect and on your first part so we expect to get from them.

That did see committed the DSM V Committee.

That's a safety monitoring committee that is doing the analysis and more precise overall number of patients needed for the trial. They are four state four stops that could be made.

Up to as I said and also had a 1400 patient.

Including overwhelming there is of course is always the risk for fertility, but.

We think that the chances here very low this will allow us to give investors better timelines for both NDA submission and later on approval and last patient in and we will give a sense that we are meeting.

The efficacy.

Primary endpoint.

In terms of being able to state that we are meeting that this 50% reduction of infection. This is what we expect.

And you were asking about the additional patients or are you referring about the additional patient post close to 750 patients.

You kind of answered it to be honest with you.

Okay. It looks like we are doing well I guess my question really was if we did hit that sort of futility analysis way.

Yes, I would just submit but it sounds like.

That's a small percentage chance or is it basically is really just that we're going to kind of get a.

More accurate sample size.

Is my understanding correct.

Youre right and as we said we are in.

Today's release, we are very close to this analysis and we expect it very soon and we are now it's about 900 patients. So you can get from that a sense of what will be the overall size of the trial.

If we ended up in occupancy.

Okay great.

Quick questions. So thank you very much.

Thank you.

Next question comes from the line of Charlie <unk> from JMP Securities. Please go ahead.

Hi, Thanks for taking the questions first.

First quick one on the loan facility.

Next $2 5 million tranche positive interim.

Just want to make sure that designation also includes upsizing the trial.

Sorry can you repeat the question please.

A positive outcome to enable the $2 5 million tranche from the loan facility.

<unk> that includes upsizing the trial.

Yes to some degree yes, yes.

No.

Okay, Great and then I guess.

Maybe for already but the main question, we get for duplex 100 is what's going to really motivate the surgeon to use it.

You presented data at the hospitals motivation is clear and the penalties that they can't get from infections.

We have the market research do you have the quote about an ethical obligation to use the product if it shows a benefit but youre also giving the surgeon is something else to think about so I guess can you maybe go into a little more detail about how youre going to convince.

The surge in themselves to give this product. Thank you.

Yes sure so.

In our conversations with.

With the surgeons.

Really.

It's really a straightforward conversation I would say, it's one of the more.

The easier conversation that we have because of doctors.

First of all.

Surgeon know knows they're there.

Ssi right. They know the department right they know what their benchmark compared to to what other hospitals and other departments, you and honestly nothing that exists today shows the significant reduction in <unk>.

In Ssi, so when we show and we're going through another another kind of research right now when we show up.

60% reduction.

Investors get it. So now there's a question there is a question of cost and ask the questions of the farmer economics.

It's.

It's a full package.

Between all of it we will.

We will use data we are collecting really an enormous amount of data from the phase III. If you can imagine 900 plus.

A trial. This is one of the bigger colorectal trials being done.

In the recent decades, so there's really quite a lot of data here and doctors are interested and even even beyond what we're testing right now we hear conversation and questions.

We will be at conferences like the cloud was mentioning earlier.

The conversations are pretty are pretty straightforward, what a 50% reduction can you two patient outcome to doctors management of time conductors management of wound care.

So it's really it really will.

It will be a complete the complete set of data around that and of course, we're collecting the farm economics, which is a big driver of that.

I can tell you that from.

Well from a conversation that we had last week with the.

A board member of one of the one of the bigger idea in New Jersey, and he mentioned to us that the CEO and the entire <unk>.

Management of the of the IGN are measured part of their annual goals and their bonus is measured on reduction of hospital acquired infection.

Yes, there is a big driver from the patient, but Theres also a big Big driver, we see and we expect to take advantage of top down from the from the management from the.

Overall administration of the hospital.

Thank you I would like to hand back over to the speakers for final remarks.

Thank you for joining our first quarter, earning conference call I would like to reiterate how excited we are about the progress we have achieved to date, especially in our duplex 100 clinical program as well as the opportunities that lay ahead of US we remain great.

To our team members and all of our external partners for their commitment to our mission and their support in continuing to advance toward achieving our goal of bringing the plus 100.

With care providers and patients as quickly as possible.

Look forward to speaking with you on our next call.

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

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Yes.

Okay.

Yes.

<unk>.

Yes.

Sure.

Yes.

Okay.

Yes.

Thanks.

Sure.

Thanks.

Yes.

Okay.

Thank you.

Yes.

Right.

Okay.

Sure.

Thank you.

Sure.

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

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Yes.

Okay.

Yes.

Okay.

Yes.

Thanks.

Okay.

Sure.

Great.

Okay.

Yes.

Great.

Yes.

Thank you.

Sure.

Yeah.

Okay.

Sure.

Okay.

Sure.

Okay.

Thank you.

Yes.

Okay.

Thank you.

Yes.

Sure.

Okay.

Yes.

Okay.

Yes.

Thanks.

Great.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Yes.

Sure.

Yes.

Okay.

Yes.

Okay.

Sure.

Okay.

Yes.

Okay.

[music].

Yes.

Okay.

Yes.

Okay.

Yes.

Okay.

Thank you.

Sure.

Yeah.

Okay.

Yes.

Okay.

Yes.

Yeah.

Okay.

Yes.

Okay.

Yes.

Okay.

Hum.

Yes.

Okay.

Yes.

Okay.

Thank you.

[music].

Okay.

Thank you.

Yes.

Okay.

Yes.

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