Q1 2021 PolyPid Ltd Earnings Call
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Greetings and welcome to the Poly pet first quarter 2021 conference call at this time participants are in listen only mode.
As a reminder, this call is recorded and I would now like to introduce your host for todays conference. Mr. Bob you to eat from lifestyle advisors. Mr. You teach you may begin.
Thank you.
And thank you all for participating in Pollock Pizza first quarter 2021.
Earnings Conference call.
Joining me on the call today will be a mere weisberg, chief Executive officer, and declared chops, because OXXO broad executive Vice President and Chief Financial Officer of Hollywood.
Earlier today, probably paid now released.
Results for the three months ended March 31 2021.
A copy of the press release is available in the investors section of the company's website Www Dot Polly P 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, National news, making forward looking statements. When he discusses the expected recruitment for trials timing of trials and or at least the trial results thereof.
Pat.
Cassidy of the company's manufacturing facility.
The potential benefits of plaque and I'll go back.
And the sufficiency of the company's cash to for.
On 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 filings with the Securities and Exchange Commission.
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 are for you should not place undue reliance on these statements.
I encourage you to review the filings with the FCC, including without limitation. The company's forms 20-F, and 6K, which identifies specific factors that may cause actual results for events to dish.
For 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.
Conference call contains time sensitive information and speaks only as of Hawaii broadcast today May 12 2021.
With the completion of those prepared remarks, it's my pleasure to turn the call over to Amir waits for CEO Amir.
Thank you Bob.
On behalf of for all of the team at <unk> I would like to welcome everyone to our first quarter 2021 earnings call.
I will begin today with some brief introductory comments and then the cloud will provide a detailed update on our business and they will review our financial results after which we will open the call for questions.
I am very pleased with the recent progress we have achieved in advancing our development program.
In line, continuing our evolution towards becoming a commercial company.
As you know.
We are currently in the large phase III program with our lead US a duplex 100 for the prevention of surgical site infection.
The site.
The cloud will provide further details on these programs shortly but I am excited to report today that the ongoing shield. One trial is proceeding as planned and we are having great success accelerating environment into the cyst study.
Moving over.
Our second phase III trial in abdominal surgery she'll two is also advancing as expected with new sites opening at the robust FES.
As a reminder, these two phase III trial will serve as a basic for Polyped for new drug application submission and we believe will contribute to support a broad label for the prevention of Ssi.
Importantly, our board duplex 100 development program is supported by a vast patent portfolio. In fact, we now have other than one patents granted in the low of the worldwide for our platform and products.
I'm also pleased to report today that the other manufacturing facility is now fully scale up.
This facility will be able to support the first two months of product demand worldwide.
As you can see polyp at this recently achieved important progress in all aspects of its business. We also continued to be supported by a strong balance sheet, which we expect to be sufficient to complete the shield one study to conduct.
Actual two and prepare for the submission of NDA as well as a further advanced our encore pit development platform with cash on hand.
I will now turn the call over to the cloud to provide you with some further details on our business day clock. Please take it from here.
Thank you Amanda 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 and the pace of enrolment in the shield. One trial has been strong to date and is expected to continue to accelerate the recruitment rate in the shield one trial doubled in the last three weeks.
And we now have nearly 200 patient enrolled into this study.
We believe the recruitment rate will continue to increase as several centers have been recently opened and you won will open throughout the current month.
Importantly, approximately 70% of the patients currently enrolled in shield one have a color that's tough cancer diagnosis at rates similar to the 74% seen in other successfully completed phase II trial, meaning that we are talking about high priority surgical procedures that are less influenced.
By the COVID-19 pandemic worldwide.
Oh for the data safety monitoring committee interest.
In charge with the with you for cumulative safety data and study conduct for shield. One study has now recommended for the second time to continue the study without modification, meaning that no safety issue related to the deep looks 100 have been upset in shield one to date based.
These collective got to a point, we continue to anticipate definitely ability of top line data from shield one by the end of this year.
As a reminder, our plan is to enroll 616, two 900 patient, we can 60 centers and day.
U S EU and Israel.
Following day enrollment of 500 patients. This study design for fights for the blinded sample size re estimation.
Just on the overall infection rate observed in this study.
Moving on to which has brought eligibility criteria didn't shift one including minimally invasive surgical procedure also continue to progress as planned.
Our initial focus here remains on opening centers.
Second trial will enroll approximately 900 1400 patient across 60 hospitals are different from day, one participating in the sales once that day.
From a commercial perspective to reiterate what we have said previously in order to maximize our commercial success in the U S. We have begin to establish our own footprint in the U S to initiate commercial preparation activities, while also exploring potential partnering opportunities with leading pharmaceutical.
Nickel companies.
Recently completed a large U S market research project to ensure optimal positioning and coverage of duplex 100.
That included a total of approximately 90 in depth, one hour interviews with pharmacy directors and other hospital administrators and a mix of general cardiac and orthopedic surgeon.
The result of this work only strengthens our confidence in the U S commercial prospects for duplex 100, especially in abdominal surgery.
Most interestingly, while both hospital administrators and search and reported a significant need for a product like this 100 day hospital administrators, we're especially enthusiastic.
<unk> hospital administrators pushback on new technologies more so than surgeons. This does not appear to be the true for duplex 100, we.
We believe the view of hospital administrators is indicative of the significant cost burden of treating surgical site infection with associated for long lengths of stay and the fact that hospitals readmission of Medicare patient flow exercise or not reimbursed by CMS ultimately these small countries.
Which will support our efforts to demonstrate favorable health economics for hospitals to drive the commercial potential of our drug candidate in parallel. We also remain in active discussion with potential partners for the U S EU and Asia market before I move on to the rest of our pipeline I'd like to take them all.
I want to discuss money Secretary and other key area, where we have recently made important focus and some of you noted earlier.
Factoring facilities now fully scaled and can produce the first 30 months of anticipated commercial demand for duplex 100.
We recently ramped up our capacity by two and a half times to achieve this critical milestone. This is a key milestone in our vision to become a fully integrated biopharmaceutical company.
Looking farther ahead, we are currently evaluating potential plans for additional manufacturing capabilities to address product demand behind the first for the two months.
Now I'd like to elaborate on the status of phone complex, how intra tumoral chemotherapy product candidate for solid tumors, including tumors that are chemotherapeutic resistant on complex provide for long and controlled exposure to docetaxel.
I don't for the most widely used chemotherapy agents in the intraoperative tumor resection setting the controlling prolonged released at the tumor resected side have critical impact to prevent the local steel movie occurrence and the potential spreading of cancer cell and ultimately improve the overall.
Survival of cancer patients. In addition on complex is expected to significantly reduce the known toxic systemic exposure one of the important attributes of successful local delivery in cancer therapy, you will recall that late in 2020, we announced positive preclinical.
EBITDA from this program innocent Genic, my mouse model for solid tumor colon carcinoma, using cancer cell highly resistant to dose at excel amongst the most treatment resistant tumor cell types are single local application I'll phone complex generated significantly better results compared to the.
Group treated with six cycle of systemic docetaxel treatment in multiple key measures, including overall tumor reoccurrence overall survival and overall tumor free survival.
Moreover, we recently generated additional compelling safety data in animal that we are excited about including positive phase two data and a promising solid tumor indication.
We are also in parallel building a network of top experts and kols around our own complex development program. So to accompany us doing development stages, we continue to conduct other preclinical safety and efficacy studies off on complex in various types of solid.
Tumors and are advancing towards the completion all for preclinical package for the filing of P. I N D request with the FDA later this year.
Although to potentially initiate first in man clinical trial next year, we continue to believe that the one complex has potential to become part of the standard of care in the tumor resection surgical setting, which is multiple solid type cancer types, including cloud blastoma prostate cancer.
And head and neck cancer, we did I will now review our recent financial results.
Let's begin with poly pizza balance sheet information as of March 31st 2021, The company had cash cash equivalents short term deposits and longtime deposit of 61 point for a million dollar as compared to $66 $6 million as of December 30.
First 2020 cash.
Cash used in operations for the three months ended March 31st 2021 totaled $5.6 million. We continue to expect that our current cash runway will extend into 'twenty 'twenty two.
And we remain confident that this strong balance sheet will allow us to complete our first phase III trial shield, one and abdominal soft tissue infection to conduct a second abdominal surgery study showed two and to prepare for the submission of an NDA for duplex 100, now lets turn to.
Other income statement research and development expenses for the three months ended March 31st 2021, or $6 million compared to three point for a million dollar in the same three months period of 2020.
Spending increased due to the ongoing shield, one and shield two phase III clinical trials and up Domino surgery.
Marketing and business development expenses for the first quarter of 2021 or $700000 compared to 300000 dollar for the same period of 'twenty 'twenty.
These expenses increased primarily due to an increase in marketing and business development personnel in our offices in New Jersey, and an increase in market facing activities. As we began building our commercial infrastructure and general and administrative expenses for the first quarter of 2021.
With $2.1 million compared to $700000 in the prior you pivot as cost increased due to being a publicly traded company with higher DNO insurance cost and an increase in noncash share based compensation for the first quarter of 2021 the company had.
Net loss attributable to ordinary share of $8 7 million as compared to $5 9 million in the prior year period.
We will now open the call for your questions operator.
Thank you.
As a reminder, if you wish to ask a question.
One.
Keith.
Right.
Your first question.
Your line.
Yeah.
From Barclays.
Hi, good.
Good morning, and thanks for the questions on.
Shield, one could you I.
I mean, my other of how many sites have been activated you.
Reassuring to see the patient enrollment data, especially on the last day rate.
We expect that this.
Likely to continue based on our earlier discussions that sites have been activated and patient enrollment is going to be faster. So is that trend that's going to be for Q2 and that means that we would be going through a sample size re estimation in mid 2020 magic planned earlier that's one.
Two do you have any updated thoughts around raising capital and debt.
And at what point, you Didnt view, our cash balance and said that has sufficient till end of 'twenty to 'twenty two.
But any thoughts around that would be appreciated. Thanks.
Thank you.
Good morning.
Again.
I'll start with day your first question on the channel.
The plan was to open.
We now have about 40 days.
Excavated and broadening and hoping is going crazy.
Got it.
It was not.
And in the last few weeks.
Additionally, as expected.
This is why we've seen.
The increase.
We expect.
As he said we nearly record good day.
Okay.
Finally for to be flat at the time line remain as as we expected.
I'll have the non full size SUV.
500 patient.
Yeah, that's right.
For Q3 early Q.
Q3, probably so.
King.
Excuse me.
You'll have to do it.
And after that we will be able to report top line results by the end of free here.
So we are line.
Yeah.
At this stage with moving forward.
And it will be shortened.
With regards to find other things, though your standard.
We ended the quarter, we'd owned it for.
$1 million.
Cash cash equivalents with guidance.
Cash flow.
Net cash mission find that share.
One.
That's what.
We got oncology.
So we don't see any immediate need to raise money.
And we think that that's it.
Central.
He made after the top line.
Thank you Daniel I'll, just one follow up maybe you called out.
Interviews with hospitals and hospital and hospital administrators recently, so oh in terms of findings, how diff'rent, where your takeaways from the earlier research study conducted at all around a year ago.
Any incremental findings that was different from what he had done earlier. Thanks.
It was very similar.
Which is again reassuring reassuring I think once we get one.
Expenses in a way that the product is more mature the clinical trial mature we are now describing when describing for surgeons.
The products weighted actual positioning in terms of potential NDA.
Because we know what is the phase III, how many patient.
Based on something that is for.
Sure in terms of that.
Thanks, Paul.
The aspect of a hospital administrator.
Uh huh.
Yes.
Economic value from Florida, similar to what we've seen in the past.
Maybe a bit for that.
We've seen other aspects of pricing was very similar.
Right.
<unk>.
So this is for.
This is not a trend.
Understood. Thank you.
Yeah.
Thank you. Your next question comes from the line of Gary Nachman BMO capital market.
Hi, good morning, good to hear all the progress so as you accelerate the rate of enrollment for shield, one does that hold back the enrollments for shield to in any way.
Just remind us how much overlap is there between the sites in the study.
And then also what's the average number of patients being enrolled per site at this point in shield, one and what number do you think you need to get to in order to get the data by the third quarter.
Sure.
First of all good morning, and thank you those are very good questions with regards to share that.
It was a different sensors.
Actually the only there was only one.
Center.
Bye.
Decision.
They have different sensors in order.
To avoid a competing.
Competing between the two.
For the two trials.
So that was a totally different center.
It's different.
We exceeded our insureds.
101 reaches a point where it's at.
Oh.
Centers of that.
The maximum capacity of recruitment for <unk>.
We could do for them, but there wont be any overlap during the trial.
You were also asking about Oh, the patient type of extreme interest.
When the center.
It's still early to say because we are.
200 patients.
600 patients.
Uh huh.
And some center.
Since the beginning of the trial.
Some are open for one.
But we see a very nice distribution.
We expect it to be.
Good day.
For less similar ways.
Centers like between countries, so depending on the number of steps.
We don't see patients coming from one country or from one center.
Oh for.
The other so yes, there is some differentiation between but then it's quite.
Quite similar in terms of having several patients who named sector.
Average assumption as we said in the past.
Centuries.
In average along the trial one patient per month per center.
And this is what we are seeing we're seeing it.
Okay.
So we expect to continue in this way the statistic will be more or less for the same between center you were also asking about.
The overall number of patients.
If you recall.
Wow.
I know that a doctor and allow us to record between 616 to 900 patients.
And we can make the decision.
Between this range after having rooting.
500 patient sample size re estimation ISR.
Options are based on the 600 patient.
But again at that stage, if we decide to add.
If you could you share a few dozen station it shouldn't be more than the one two.
Time, because at the end of day opening in the recruitment we have oldest centers up and running.
We are at this stage for recruiting.
More than one patient.
Ben Shim from.
This is an average along delightful for that trial.
The wavelength doing.
All the time.
Okay. That's very helpful. And then just a follow up on uncle Quack. So just what other gating factors to starting.
A phase one study is it just resources it sounds like you're confident you'll have behind the meeting before the end of the year.
And you're collecting a lot of data here preclinical data. So just maybe talk a little bit more about what you think that package is going to look like and just your confidence that you'll be able to have that meeting before the end of the year and then starting the phase one you know at what point next year will you be.
Well to do that.
Sure.
We are very excited with this program and we see them how they experienced since we've gained 100 with a development with a plan for how we are able at this stage for short at the development things that are.
They've taken out there for them.
Here, it's for duplex 100.
For example, a CMC processes and preclinical package.
I was taking place in a matter of months.
This is a very exciting program within the company.
The other two.
All the knowledge that we have.
Again, we see for next 100, whether it makes it regarding.
The net Tory regarding manufacturing preclinical.
Is it taking place.
Place for where we are confident that we can meet the get to the pre I N T.
Yeah of course, we are.
We don't know what will be raising debt. Our assumption is that we should be in a position to start pushing that next year based on our understanding of what will be required for it.
But we'll need to hear from the FDA and see if they agree with top line.
It will also be in a position to share more information with investors on this program in terms of safety and efficacy.
And then it comes down.
So I think we will be able to update on this program along the year as we get closer to that.
And the fact that we will also have some additional efficacy studies in animals.
But for now we are confident that day.
This is doable.
Okay, great. Thank you very much.
Thanks, Gary.
Thank you your.
Your next question comes from the line of Elliot Wilbur from Raymond James.
Yeah.
Thank you good morning, or good afternoon, and good to hear your voice and our thoughts are with you and your families in these very difficult times.
My first question just basically wanted to ask a follow up question on the uncle Plex program. It sounds like Theres been a lot of progress in a very short period of time.
When what might we expect additional data points publications et cetera.
Yeah.
Anything we might see before the end of the year on that program and are in the public domain.
As you think about initial first in man trials are you thinking about a specific tumor type at this point or would you expect to.
Initiate trials in the range of tumors that you outlined earlier.
So that's all thank you for for your kind words.
We have made for one thing we do expect to be able to share more of this.
For doing this.
Yeah.
Sure.
For safety as well.
Sure.
As well as the efficacy with regards to the specific indication. This is the process what we have.
Yes of course, we do have some thoughts here and.
Ed.
Yeah.
Things that we think that the more likely but we wanted to make sure with animal studies.
Things are looking as expected before we make a final decision and submit that to the F. D. A.
And we'll make the decision again based on the day well.
The other data and make a decision whether it makes more sense with.
One indication and.
And for the product first.
Take it first to searching Manning.
One indication and have more for bundle type of submission.
But I don't want to.
Is that to say anything before we actually see the data.
And again I'm, saying this again, we expect to be able to share.
Share this data before the end of next year before.
Thanks for the free IFC.
With regards to additional efficacy.
Uh huh.
Okay.
Okay.
And I have a question with respect to the market Research study of project that you mentioned earlier, it's encouraging obviously they hear the favorable feedback from hospital.
Administrators, obviously, they they kind of get it in terms of the incremental cost, but curious if is there anything you could share in terms of.
Their impressions of some of the price points that you have talked about for the product earlier, assuming that that data to some extent was shared with them and if there's anything that you could convey.
Convey to us in terms of their receptivity around some of the.
Price points that the company had been previously considering.
Considering and then with respect to them.
The commercial side or feedback from surgeons anything that you learned thus far from that study that maybe.
Maybe is somewhat different in terms of what you were previously thinking about with respect to commercial positioning other product.
Uh huh.
Couple of points here with regards to pricing we got reassured.
Thinking on pricing.
Got it.
This is Dave.
They view that in terms of sensitivity.
We could even say that our oh its options that were presented based on 50% reduction of infection.
Got it.
Yeah.
All of efficacy in the phase threes.
We could even consider higher price.
Than we initially thought but again this is too early really to see what comes out from the phase III that makes the final decision.
I think another thing that we.
Clearly see both from this study by discussions with the opening centers. That's the reason that's needed for colorectal resection.
Moving on in general for specific came from the Rexam resection, a lot of other patient having section.
And this is not just holding back then.
Search engine sales of Citi.
You should all have a securitization day, we had for me.
Sure.
Also hurting the patient.
Fixed off most of the surgery.
Apology surgery also for patients coming to the hospital for colorectal resection.
Doing that due to cancer tumors.
And this is holding them back their oncology protocol.
They should go to the either radiation or chemotherapy a few weeks.
Terry if they have any infection this delay the process.
Jeopardize their loans.
Apologies for treatment.
Chemical treatment. So there is a lot of benefit here in terms of patient health as well as held for clothes for me at least.
It's quite clear from the market research.
Okay, and then just last question day play theirs.
Obviously, there's been some incremental spend tied to commercialization efforts in the U S. But anything specifically you can share in terms of.
In terms of key hires or what exactly the investment has been targeted towards thanks.
So we are very cautious.
Cautious here in terms of Ah.
Budgeting and expenses.
We.
Looking at the walking dead.
That is needed to meet the timeline for commercialization. This market research that we've done and we are looking to build a plan for commercial there are discussions since we are having in parallel.
Yeah.
So we do have.
Thank you Paul.
There's on working and this is something that we are.
We are cautiously progressing on especially with things.
There's a credit card in the past for commercialization.
Whether it goes to packaging.
Naming and things that needs to be done today in order to hold up I mean would you like to add to that.
Thanks.
And for it I just want for it sounds to guidance about the research market I think that's what is more clear to us in this research buckets, if I compare it to the previous work force.
Neil.
And we heard from doctors and from the administrator.
This was.
Very good support for our other boat.
Give us towards a standard.
That's great.
Great.
Sometime.
So for activities like I said.
So both of them.
Very happy to see this kind of product in the market.
Oh my goodness.
If you wish to ask a question press. The Star then one on your telephone keypad.
Yeah.
Okay.
We have no further questions if you wish to continue.
Yes. Thank you for joining our first quarter 2021.
For this call.
I would like to repeat how excited we are about the progress we have achieved up to date as well as the complaint books.
The line.
Uh huh.
We remain good for low to our team members and Oh, probably other external process for them.
Strong commitment to our mission and their other corporation to ensure that we continue to advance toward achieving our goal of for banking.
The two heads current providers and their patients as quickly as possible.
Thank you very much.
Thank you that does conclude your conference for today. Thank you all for participating and you may now disconnect.
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