Q3 2020 PolyPid Ltd Earnings Call
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Good afternoon, ladies and drugs.
Thank you for standing by welcome to todays spot with its first quarter 2020, the conference call.
At this time all participants on this Oh multi mode presentation will be followed by a question and answer session at which time you wish to ask a question you want to press star and won.
Muscles Advisory meeting is being recorded today on that.
Once they the 11th of November 2020.
I would now like to hand, the meeting over to your speakers today. Please go ahead.
Thank you for participating in <unk> third quarter earnings Conference call.
Joining me on the call will be a mere weisberg chief Executive officer.
<unk>.
Right.
Right right.
Chief Financial Officer.
Earlier today.
Financial results for the three and nine months ended.
Number 30 at 2020.
Copy the press release is available on the investors section of the company's website at <unk>.
W Dot <unk> dot.
Dot com.
I'd like to remind you that on this call Matt.
Forward looking statements within the meaning better.
Our old Securities law.
Forward looking statements are subject to numerous risks and uncertainties many of which are beyond our control, including the risks and uncertainties described from time to time in our FCC filing.
Our results may differ materially from those projections.
These statements involve material risks and uncertainties that can cause actual results or events materially differ.
Accordingly, you should not place undue reliance on these statements.
I encourage you to review the Companys filings with Securities and Exchange Commission, including without limitation, the company's form F. One and 6K, which identifies specific factors that may cause actual result work that.
For materially from those described in the forward looking statement.
He described disclaims any intention or obligation.
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 and speak only as of the live broadcast today.
<unk> 2020.
Back 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 all the team at 40.
I would like to welcome everyone to our third quarter Twentytwenty nickel.
I will begin today with some brief introductory comments and then Dikla will provide an.
I bet on the outlet business and they will review our financial results after which we will open the call for <unk>.
I'm extremely pleased with this focus we have achieved in advancing all that they've done nothing for go in a continuing outwear evolution toward becoming a commercial company. That's you know we are currently in phase three with our lead. They also depicts one on that for the prevention of filter concise in fact.
Oh, it's a slight decline.
The cloud we provide further details on this program shortly.
So I think what we bought to date that our ongoing shouldn't do out of time for sitting as planned and we are having great success in adding new clinic a sentence for <unk>. Our right. This is the first full free our two planned phase three clinical trial in soft tissue surgery.
We are also preparing to conduct our second phase three trial in abdominal surgeries shields through which we expect.
Initiate before the end of this year importantly, these two phase three trials with <unk>.
The basis for quality, the first new block application submission.
<unk> mission and we believe it will contribute to support a broad label for the prevention of Fair Society.
Beyond our lead indication. We also had ongoing clinical development program for the Black Swan holidays fall that prevention Welfare Society in bond issue such as the symbol in open heart surgery.
Mission.
Oh, the promising corplex locally into a tumor novel therapies for their clinical program continues to generate promising early results. The cloud and also provide updates on these sales to four commercial.
As you can see quality does it or bus ongoing development programs for our innovative flex technology, Oh, well I guess, if I envy initiative supported the body a strong balance sheet, which we expect to be sufficient to complete the shield, one study and to initiate and conduct.
[noise] tool as well as preparing for the submission Oh finlandia through the <unk>.
I will now turn the call over to close to four or five youre with some further details on our business. The clock. Please take it from here. Thanks.
Thank you Emily and thank you all again for joining us on the call.
I would like to begin with a brief discussion on the status of our pipeline following.
Following the involvement of our first patient in the shield one trial in July we have continued due to open clinical trial centers at the end.
Impressive pace in.
In fact in just a few months since the enrollment of the first patient in the study over 50% of the planned 60 centers have already received high up the approval.
And the vast majority of these sites are now open to enrollment.
As a reminder, our plan is to enroll 600 to 900 patient we didn't 60 centers in the U.S. Yoo and Israel.
Following the involvement of 500 patients. The study design to provide for blinded sample size re estimation based on the overall infection rate observed in the study.
We continue to anticipate the topline result from shield, one will be invaluable in the second half of Twentytwenty one.
We also expect that the initiation of a second abdominal surgery study she will too.
Which will have a broader eligibility criteria, including minimally invasive surgical procedure will occur before year end.
The second trial will enroll approximately 900 1400 patient across the same number of centers.
We have contracted with a lesion COO to support the study and definitely already engaged with a number of Sanchez globally to participate in the trial.
We are very excited about the important progress we have achieved in advancing our pivotal development programs. So deep fix 100 in abdominal surgeries.
And we look forward to providing investors and analysts we didn't update once the first 100 patients have been involved in shield one study.
While the operating environment for conducting clinical trials continues to evolve due to the ongoing global coffee 19th and dynamic. It is important to note that we can reasonably expect.
<unk> over 70% of the colorectal resection surgery patients to be enrolled into these two clinical trials will have cancer diagnosis in our previous phase two study in 200 patient, 74%, often well patient had colorectal cancer.
Therefore, these will be deemed high priority surgical procedure in hospital.
From a commercial perspective in order to maximize our commercial success in the U.S.
We have begun to establish out on footprint in U.S. to initiate commercial preparation activities.
Also exploring potential partnering opportunities with leading pharmaceutical companies.
In the U.S., we are beginning work around branding packaging and distributing conducting market research on the current landscape and significant unmet need for the prevention of exercise.
And it started to establish a team into it.
To support the anticipated commercial launch of the product.
In Europe, we are currently evaluating commercial strategic partners to.
To maximize the future commercial value of duplex 100 in this market.
As we have said in the past significant commercial opportunity exist for the prevention of <unk> base.
Based on industry data out of 30 million hospital inpatient surgical procedures conducted in the U.S. in 2015, there around 14 million procedure were about 45%.
All inpatient procedures defined as our target market.
These are major surgical procedure with a high risk of exercise.
Such as though.
Soft tissue for open up Domino procedure as well as dose you know to Pee dee cardiac procedures.
Well assist size often leads to disabling and sometimes even life threatening complications.
For the prevention of exercise in bone tissue, we intend to evaluate next clinical steps for an open heart surgery phase three trial in the first half of Twentytwenty, one which will allow us time to ensure she'll two is progressing as planned as a reminder, in a random.
<unk> phase one phase two trial of 81 patient having open heart surgery. There were no infection in the 58 patients treated with depicts 100 compared to 4.3% infection rate gain to standard of care.
We focused on bone tissue due to their high risk of morbidity and mortality in cases of deep step surgical site infection induced procedures.
We negotiated out face be borne model trial in open heart surgery earlier, this year and intend to submit the data as a supplement to the abdominal soft tissue surgery and D.A. submission.
This trial will enroll 1300 to 1600 patient in 45 centers across the U.S. Yoo in Israel.
Both abdominal and bone tissue surgery pose significant creates a fair society for hospital patient.
Patients developing infections following surgery very often in corrpro long length of stays Riyadh.
Three admissions and went deep infection to care increased rate of free operation.
In cases, more superficial infection additional cost for debridement once cleaning negative pressure wound therapy and other medical treatments, how often into it.
Over since infection rates and re admissions are used by CMS as one of the quality measures in setting a hospital reimbursement level high infection rates can negatively impact the overall payment trades by CMS to the hospital for it.
Example, in 2019, Medicare Panelized to New York Presbyterian.
While Cornell medical center, which more than $9 million in penalties tied to the hospital acquired infection reduction HSBC program and we admission reduction H R. T program.
That includes yes aside metric these types of penalties can have a significant impact on a hospital's total budget.
As I said, we are also very excited about the potential of our pipeline candidate uncle picks which has an intra tumoral chemotherapy currently in preclinical stage.
At the end of this year.
We expect the availability of preclinical data for these compelling opportunity. In addition, we plan at the time to be in a position to provide anticipated timeline for planned pre investigational anti a meeting with the FDA and 40 initiation for first in man study.
Andy.
Moving onto the balance sheet as of September 30, Twentytwenty. The company had cash cash equivalents and short term deposits of seven tea.
$1.8 million as compared to $26.6 million as of December 31st 2019.
Cash used in operations for the first nine months of Twentytwenty totaled $16.8 million.
To reiterate what time you said, we believe our strong cash position will allow us to complete our first phase three trial shield, one in abdominal soft tissue infections.
We initiate and conduct the second abdominal surgery study she'll too and to prepare for <unk> for the submission often N D.
Now, let's turn to our income statement R&D expenses for the three months ended September 30, Twentytwenty were $4.2 million compared to $3.8 million in the same three month period of last year.
As spending increased due to the initiation of the phase three shows one clinical trial and preparation for the phase three shield two clinical trials.
<unk> expenses for the three months ended September 30, 20, $22.2 million compared to $1.2 million for the same period last year.
Cost increased as we became a publicly traded company. We hired you know insurance costs and we also had an increase in noncash share based compensation.
For the three months ended September 30, Twentytwenty. The company had a net loss attributable to ordinary shares off $6.5 million compared to a net loss of $2.1 million into three months period ended September 32019.
We will now open the call to your question operator.
Thank you, ladies and gentlemen, well now begin the question and Sasha if you'd like to ask a question. Please press star one on your telephone.
And wait for your name to be unknown.
Ken can solve your request at any time by pressing a husky.
Once again this.
And one final question.
And your first question is from the line of God right and that's one of the capital markets. Please go ahead.
Hi, guys good morning, and.
Good morning, the first abdominal good morning, so the first abdominal phase three have had good progress activating sites, but how long to get to the full 60 target that you highlighted.
And.
And then you know what you consider fewer sites if it becomes more challenging to activate them and have you been rolling your target of around one and a half patients per month per site how's that been going.
So good morning, Gary and thank you for that if you recall in our previous.
Cool thanks, guys.
But we expect that by during the quarter, we will be opening system.
Sentences centers as.
It has worked very well for us and we are very pleased that we just.
Four months time, we have all of those strategies centered.
Locally in the U.S.
Now that we have already received.
Well.
Option as it did.
Well.
Easier as we go because you can imagine if they're not stopping.
But all the other.
In the process.
So they should be coming as we go along.
We indicated that we view that the bank.
Recorded message will be between one.
Patient.
Current centers, we are not considering at this stage opening that center and the reason is that we want to.
To be ready for it.
Changing the settlement due.
Due to COVID-19 specific hospital.
Closing their surgery department for a period of time, giving.
Thanks for coffee station.
We are still going to open to 60.
And then two today, we haven't seen any reason.
To change at all right.
Well, we didn't do too to the couple of it with regards to the.
The face of recruitment of patients and we said with the next time.
I'm going to update will be when we reach the first good.
Assumption is that this will be early next year.
2000, 2021 and 2021.
Okay. So the sample size re estimation.
Did you want everything I'm here I'm sorry.
Sorry.
Hey, Thanks, Tim now it looks good and.
We believe that that is 65 cents and support.
Something will happen with the Colby Thanks, Dave.
Up until now everything is.
Okay. So.
So the sample size, we estimation that should still be in the middle of next year around July time frame, you said data in the second half, but sounds like you're on track for the re estimation midyear.
Okay.
Okay and.
And then the second abdominal phase three if it's more minimally invasive procedures, how much might that be delayed by the whole co that situation. How can you potentially get around that and could you have data on that study later next year or would more likely be into 2022.
So.
The trial is going to start with.
In the coming years.
Just before we then in less than a half less than that.
So you can imagine that a lot of work for renegotiation is already.
And we are feeling comfortable about this drug.
The fact that the board.
Invasive steel.
Over 70% of the patient will be cancer patient.
So still though in some cases, there is a possibility to do the surgery lumpy.
Nothing else could.
Still goes on cancer patients.
So those are still high priority surgery.
We did.
Yes at the moment and we don't proceed for the coming few.
That is deemed.
On T. surgery will be delayed.
So again, we did gain.
Getting the gap between the two trials. So we started the the Uh huh.
Second at the beginning of the third quarter and we.
Now starting the second one we are holding off on the external.
Make sure Oh, each drop all these up.
The sensors are in play but for now we don't see any.
Any reason that those will be delayed because these.
These are still similar population.
In terms of the reason for surgery.
Okay, and then Oh.
Yes with regard to your question regarding read out so.
Not too.
I think to do we call. These 19. The fact that this is a more paula.
In terms of minimally invasive okay.
The larger volumes between 100 1400.
Posed in each one.
So we don't feel not be next year, it will be 2020 sick.
252.
And it has nothing to do this was on plan to start with so called it didn't change here.
Okay.
And then lastly, I think Amir in your opening remarks, you said that with these two initial phase three studies, you could submit and that should be enough for a broad label, but that would just be in soft tissue right to have a broader label in bone you would need to submit the.
During them study as a supplemental filing just wanted to confirm that.
Okay.
All right all right. Thank you guys.
Thanks, Andrew.
Okay.
Thank you once again to the style and one for any questions. You may have your next request is from the line of Balaji <unk> of Barclays. Please go ahead.
Hi, good morning, Thanks for taking the question just a couple more from me firstly.
Firstly on now can you update us on the Dell developments on the commercial build outside and how.
How do you see that impacting.
All banks, our cash runway for its materially different versus your earlier communication and maybe that's also a good segue to discuss Ah.
The current cash balance on the run rate provides for you all with you. It is accurate is thanks.
Hi, good morning.
Good for you so we got.
You and separation so we are increasing.
So I think it's not.
Going to be it's going to be instead of the 1%. This was there where we are.
Looking to 3% so.
So it's not going to impact our cash flow, but we are having the ability to do some more infrastructure work.
To commercialization, we've mentioned in today's press release of some points regarding health economic granting packaging things that and it's a bit more run way in order to to reach to the point Oh commercial and D.A.
We do all the right data. So we don't envision. This then changing in any way our runway.
And with regards to our cash position again as we said.
Sales that earlier this year, we expect cash to be sufficient into 2022 printing.
Yes.
Great and on.
On the call on complex program, so you're planning to meet the.
If the AD that ended up the year is that is that right Mike signing on safe So with the pay investigation on India meeting.
From there to so what's the gap or duration before you start trials I'm on the oncology side.
You understand it correctly, we like to get by the end of this year since the program.
Yeah.
An early stage program as we were going to say there wasn't much of valuable information to investors.
The end of this year, we will be in a position to share much more.
The four preclinical data of some a characteristic of the uncle thanks, everyone.
Everyone.
To endear and two first in man so its not yet.
Before the end of the meeting that try to time that for that.
We do expect that we should be in a position to next year, we will have in that.
The meeting with the ft.
Thanks.
Yes, yes.
Yes of course so.
Got it thank.
Thanks again.
Thanks for that.
Thank you.
Your next question is from the line of Elliot Wilbur from Raymond James. Please go ahead.
Hi, Good morning, Good afternoon Merit Dikla.
Yes.
Wanted to ask follow up question to your earlier commentary degree around the update in shield, one with respect to the 100 patient enrollment milestone I just wanted to confirm that that in fact is just going to be an update in terms of when you hit that enrolled.
Good point, and we're not actually going to go into sheep any associated data with that update.
You are correct, we want to.
The operating environment.
Around the copy and print is experiencing delays.
No that's position, but we wanted to make sure that investors have an ongoing inside.
The progress in terms of the operating profit and this is why today weve updated that at over 50% of the centers have received divesting approval.
Jeff.
Four months Dr. from first in man.
And we are the next point that we will be updating once we hit he said one the first 100.
Mr can say that we are fine.
Fine.
Our expectation.
Okay.
A follow up to that just in terms of thinking about the overall efficiency of the program do you have a sense yet of what the expected overlap would be in terms of participating centers between shield two in shield one.
Oh, that's a good point, we do expect that there will be some over all of us.
But it's hard for us to say at this point.
But we do see that.
We already see centers that.
We would.
Good point thinking about them for Sheila that won but then decided a more profit in terms of the.
Patient population to be four shows to an already converted them. So this is very helpful for us and hopefully this will shorten timelines for show too, but it's still early before we actually start and can update after a pointer to weather.
Jason Hey, Saturday, but actually won.
Sure.
Yes.
Fine. Thanks recruiting we will we will be able to convert all of those centers.
Okay, then with respect to shield to obviously I presume the primary endpoints will be identical with that of shield, one but are there any.
Noteworthy differences in terms of secondary endpoints between shield two in shield one.
Oh.
The primary and secondary end point.
Oh quite similar and quite similar to what we have in sales.
Thanks to these topics.
See you.
Okay, and then final question just shifting more to the commercial front I'm just to get maybe your high level thoughts on.
The.
Timeline for in sort of range of possibilities around a European partnership I guess my assumption would be that you at least at this point you would strongly prefer a pan European partnership, but I wouldn't also expect anything.
Turning to be finalized probably till we saw some initial.
Data at least from shield, one or maybe at the earliest.
The.
At their sample size re estimation. So I'm just wondering if that's consistent with your thinking or if you think maybe that actually we could see something before that initial clinical data point. Thanks.
Thanks, Ryan So it's we cannot.
Relates specifically to timeline, especially when it comes to commercialization.
Uh huh.
Very.
<unk>.
From company to company from negotiation to negotiation.
From product to product, but what we can say that we are.
Continuing with our strategy that we.
Great.
For quite some time regarding having our own footprint in the U.S. and steel and to initiate commercial preparation activity were also exploring potential partnering opportunities with leading pharmaceutical companies and with that you were paying a certainty.
Geography, as well as the rest of the World we are evaluating commercial strategic partners.
We think.
The SEC has a very.
Good markets you opportunity industrial country and this is to fix it we are getting but it's very hard to get the line on that.
It could only create the expectation.
But we do not want to be.
He either meeting or beating what we can say that we are very happy with the profit.
Today.
Thank you.
There are currently no further questions. Please continue.
Thank you.
Turning to our third.
Third quarter, Twentytwenty, earning conference call.
I would like to emphasize how excited we are about the progress we have achieved to date as well as the company long term.
Thanks.
We are.
Turing to our team members and the Autoform extend were positive for the company.
Our mission and core operations to ensure we continue to progress towards achieving our goal of putting.
Thanks.
Thanks, 102 healthcare provider and.
Patients as soon as possible.
Hello.
Thank you.
Wave that we conclude the presentation.
Thank you for participating.
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No.
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