Q4 2022 PolyPid Ltd Earnings Call
The conference will begin shortly to raise and lower Johan during Q&A, you can dial star one one.
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Okay.
Greetings and welcome to the Poly Pete fourth quarter and full year 2022 conference call.
This time participants are in a listen only mode.
As a reminder, this call is recorded and I would now like to introduce your host for today's conference Brian Ritchie from Life Science Advisors. Mr. Ritchie you may begin.
To all for participating and poly Peach fourth quarter and full.
Full year 2022 financial results conference call joining me on the call today will be Glen <unk> actual Brad Chief Executive Officer of Polly P.
Our shops ski Chief operating officer for Poly Page U S operations, and Johnny Michel Island, Poly Pizza SVP finance earlier.
Earlier today <unk> released financial results for the three and 12 months ended December 31 2022.
A copy of the press release is available in the investors section on the company's website.
Ww is got Holly Pete Scott.
I'd like to remind you that on this call management will be making forward looking statements within the meaning of the federal Securities laws. For example manager is making forward looking statements. When it discusses the regulatory pathway for the potential NDA submission for <unk> 100, including the potential of the shield one results and shield two star.
I need to provide support the potential for wide use of duplex 100, the timing of resumption completion of patient recruitment.
Design and top line results of the revised shield to study the company's expectations regarding its cash runway and financing opportunities goals for 2023, including with respect to interactions with European regulatory authorities.
Ability to attract additional partners and an.
Enter collaborations and the potential timing thereof, and the expected timing for the commercial manufacturing process and packaging validation for duplex 100 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 <unk>.
<unk> filings.
<unk> 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, including without limitation. The Companys form 20-F, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward looking statements.
<unk> disclaims any intention or obligation.
Sept 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.
Only as of the live broadcast today February eight 2023.
With the completion of those prepared remarks. It is my pleasure to turn the call over to Dr. <unk>.
Thank you Brian on behalf of our teammates policies.
I'd like to welcome everyone to our fourth quarter and full year 2022.
Before discussing the details of our clinical program I would like to reiterate how thrilled we are to now have a clear regulatory pathway.
Cancel NDA submission for duplex 100 in the U S.
Positive type C meeting communication with the USDA on the shield one.
Yes.
As a reminder, in advance of the type C meeting we provided the FDA currently evaluable patients from the shield, one study evaluating <unk> 100, and abdominal colorectal cancer.
Based on these data, particularly the 54% reduction observed in the primary endpoint in a pre specified subgroup analyses of 423 patients with surgical anesthesia greater than 20 centimeters.
Third to standards of care.
Which represented a P value of 0.0032, the FDA acknowledged that the shield. One result may provide supportive evidence on this population.
Agency also recommended that the company conducted an additional study to support a potential NDA submission.
The SBA concerned with it.
Ongoing tier two study, which to date has enrolled approximately 40 patients with their coffee large surgical procedure.
It could potentially serve as such.
Importantly, the FDA also recognized please keep this one hundreds to policy indication is for the prevention of infection. This has potential for why it is.
We are currently working expeditiously to finalize the design of the device.
And expect to resume patient recruitment next fortune, we wanted to take the opportunity to date.
Some color around what this study was.
First we've used shell to Derisk phase III trial, given the more focused patient population in which we have already generated highly positive data in shield, one and the fact that it will not be conducted within the tight coffee related restrictions to 'twenty three.
During the pandemic and throughout the duration of shares one.
Moreover, we have continued to leverage the key learnings from the shield one study, notably with regard to countries and specific site and patient culture in order to ensure that we are currently leveraging these key learnings we conducted a clinical.
Advisory Board meeting late last year to gather clinical feedback from key opinion leaders specialized in Ssi.
Clearly, both surgeons and infectious disease specialists.
Tend to recruit a total of approximately 600 patients or an additional 560 subjects behind the 40 patients already recruited into shares.
Total recruitment time Eastern study is expected to be approximately 12 months from the time, we resume share two enrollment next quarter.
<unk> results are expected mid next year three months.
Felicia.
Yes.
I would highlight that this anticipated timeline is similar to the one seen each showed one.
We also plan to conduct an unblinded interim analysis, one total approximately 400 patients.
Clipped 30 days.
To put this in context.
You will recall that it took us 22 months to recruit 977 patients interesting one.
And it was during the most challenging periods of the coffee question.
Importantly, the ability to leverage the ongoing shift to study will significantly reduce the time and resources needed as.
Compared to having to initiate a new trial.
Design of the <unk> two trial will be very similar to disclose one study in terms of primary and secondary endpoints, which patient intervention on proceeding depicts 100 on top of standards of care and subject in the control arm receiving standard of care.
The primary endpoint of the trial will be a combination of Ssi re intervention and mortality rate at 30 days post index surgery.
Defined in the CDC guidelines.
Patient safety will be monitored for an additional 30 days.
Study will take place in the U S E in.
Yeah.
In Europe , as we have done with the FDA in the U S.
We're also preparing for the expected near term interactions anticipated in the first half of this year with the European regulatory authorities regarding <unk> 100.
Should add this we are working closely with our European partner advanced pharma with regards to the EU pathway and are fully aligned on the regulatory strategy for this region in regard to our financial position. We continue to expect our current cash runway to extend.
Well into the first quarter of this year.
With that said, we anticipate having a number of compelling financing opportunities.
Enhanced our balance sheet in 2023 and to fund future to a successful completion, we are grateful for their continued support shown by our largest institutional shareholders.
Moving on we have a number of operational goals in 2023, I will now ask Ali to review those alright.
Thanks, you decline.
We view 2023.
Retention lead transformational year.
Not only in the clinical and regulatory areas, but also on business development and manufacturing fronts.
From a business development perspective.
We intend to focus on attracting additional strong partners for duplex 100 in different geographic areas.
In China.
Second shift.
Shield, one validated duplex technology platform in a large clinical trial.
Riding local and controlled release of drug molecules directly disease targets, Oregon over a predetermined period of time.
This validation of the platform can serve as a starting point for platform related collaborations.
Importantly, we have the in house research development, and GMP manufacturing and support various potential partnership opportunities.
Using our in house capabilities. It is a matter of only months.
To encapsulate, new API into the flex platform and achieved proof of concept.
Flex platform collaborations will be focused on two key areas first.
The delivery of innovative drug.
Typically local delivery, where systemic delivery is either not effective enough or too toxic for example in oncology.
Second the lifecycle management of an approved drug were prolonged local delivery provide significant clinical benefit.
Specialty companies are always looking to differentiate their existing product portfolios and leveraging the flex technology is an excellent way to accomplish that.
Our planned objectives is to formally <unk> partnerships in 2023.
Though the exact pace of partnership discussion is inherently difficult to predict.
On the operations side, we expect to complete the commercial manufacturing process validation and packaging validation for duplex 100 in the first half of this year.
We plan on having the CMC and preclinical data needed to support an NDA submission by the end of the year.
With that it is my pleasure to turn the call over to Tony to review, our current financials Johnny.
Thank you Laurie as of December 31, 2022.
Company had cash cash equivalents and short term deposits of 12 6 million as compared to the $32 2 million.
At the end of 2021.
Now, let's turn to our income statement.
Research and development expenses for the three months ended December 31 2022.
There were $4 $7 million.
Compared to the $9 6 million in the same three months period of 2021.
The decrease in R&D expenses resulted primarily from the completion of the shield one phase III clinical trial.
For the full year ended December 31, 2022, and 2021, R&D expenses were $28 million and $36 million respectively.
Marketing and business development expenses for the fourth quarter of 2022 or $350000 a decrease from the $1 1 million during the prior year period.
General and administrative expenses for the fourth quarter of 2022 were $1 6 million.
<unk> to the $2 9 million recorded in the same three months period of 2021.
For the fourth quarter of 2022, the company had a net loss attributable to ordinary shares of <unk>.
$6 5 million.
As compared to the $13 5 million in the fourth quarter of 2021.
For calendar year 2022, the company had a loss attributable to ordinary shares of <unk>.
$39 5 million.
Compared to a loss of $42 6 million in the full year 2021.
We will now open the call to your questions operator.
Thank you to ask a question you will need to press star one on one on your telephone and wait for your name to be announced.
To withdraw your question. Please press star one on one again once again, if you'd like to ask a question. Please press star one on one.
We will now go to our first question.
One moment please.
And your first question comes from the line of Brandon Folkes from Cantor Fitzgerald. Please go ahead. Your line is open.
Alright, Thanks for taking my questions and congratulations on the progress.
Just a few for me if you don't mind.
Maybe just as we think of box shield. Two can you just elaborate in terms of how you control for the potential.
Although lower infection rates and the comparator arm.
And then similarly, how do we think about the health economic benefit so assuming we are successful in shield two.
How do we think about the proposition to hospitals.
When commercializing the product in this sort of larger.
Incision surgery.
Any pushes and pulls there.
And then maybe just I'll ask what's the upfront if you heard much on the interim analysis, what should we expect any chance of stopping early thank you.
So Brandon first thank you for joining us and good morning, I will start with the.
First question around the infection rates and how we look at it in terms of sheer two and then I'll, let Ted elaborate about the Els economic and I will also cover the aspect of the interim.
<unk>.
So first of all what we have done we now have a very robust.
Data.
Most of the 1000 patient, which is the basis for our assumption. Although it was all conducted during Covid and we've mentioned several times that this had an influence on the infection rate. We are taking what we've seen in this period, although might be a bit.
Conservative as our base assumption and this is also when we are talking about the de risked program from our perspective. This is another aspect of why we think this is a derisk phase III because we are taking on the assumption infection rate that were during the two years.
Coffee there are number of papers showing that there was it a reduction in infection. During this time and this is a plus obviously that we're taking but other than that and we referred to it briefly in today's prepared remarks, we've done a process too.
Valuate.
As many as they had lessons learned that could be taken both inter.
Internally, but also with external advisor we had at the end of last year, our clinical Advisory Board.
Trying to evaluate and look at the patient population.
Any parameters, where should we view them. Some of them are also potential health economics.
And how.
In the future Surgeons hospital, we'd look at the product, but also looking at the specific country specific centers all of this parameters are now.
Into the.
Protocol as well as into the operational planning.
As to the interim so the interim as has obviously a possibility for an early stop.
Due to efficacy also in sizing.
Modification as well as if things are not as we expect stopping for futility. So it's a it's a full entry and we do have prior to their entry and we also have some as we did also in shield one blinded assessment assessment that can help us to refine things.
As we go along.
Where you want to touch the aspects of the health economics, Yes, Hi, Brendon good morning, I think.
What we've seen in this trial.
I think the story itself hasn't Hasnt changed from a health economic if anything we just.
Even made it a little bit more clearer to the hospitals were now.
Better define the population would make it will make it easier for the for a surgeon to understand where the potential issuance right.
Patient comes in with other either.
Patient related risk factors or procedural related risk factors, we can certain can flag. This is this is a patient.
In risk and they apply apply duplex so when when a hospital kind of assessing the risk factor or where we're shooting for.
Where the problem is we I think we're making it a little bit more clear for them.
As before right. When there is an infection. There is additional cost from additional time in the hospital.
Re intervention Readmissions and so on but we just if anything we just made the story a little bit clearer to the hospital.
Great. Thank you for the color.
Yeah.
Thank you.
Thank you.
We will now go to our next question.
One moment please.
And your next question comes from the line of the larger Prasad from Barclays. Please go ahead. Your line is open.
Hi, everyone. Good morning, this is shelf apalachi and thanks for taking our questions. You mentioned that it took about 22 months to recruit 990 patients for shield, one and four shield II given thought to that you know patient eligibility criteria could be different for the two trials what the ECL.
Spectation on timing of the patient enrollments for shield two thank you.
So first of all good morning. Thank you for this question.
We were very clear on that so we expect that the recruitment time will be 12 months.
And this is also what we've done here. We've also looked at the pace of recruitment.
Ah patient in shield one those specific more focused population what was the the pace during shield, one and how fast we got to those numbers and extract from that we by the way we are hopeful that we will.
Have.
A faster rate, although again, our assumption was based on what we've seen in shield one because we need to remember showed one was completely.
<unk> during the coffee time, which obviously and.
Slowed down processes in terms of opening centers as well as patient going and taking surgeries and having laparoscopy test and then getting set.
The jury.
He did so all of those point slowdown recruitment, but still at the end of the recruitment we had around 250 patient third quarter.
Close to 45% out of those patient.
Were patient with incision length of over 20 centimeters.
Can't give you a sense of what's what's our expectation in terms of recruit rented at the peak.
Scott This is very helpful. Thank you.
Okay.
Thank you.
Once again, if you would like to ask a question. Please press star one on one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one on one again.
We will now go to our next question.
And your next question comes from the line of Voip accounting from JMP Securities. Please go ahead. Your line is open.
Alright, thanks for taking the questions I guess just to follow up on that on the last few questions just want to make sure I'm clear on the.
Whats the pre specified patient group for the for the primary endpoint in shield two.
Infusion over 20 centimeters are there any other criteria and then I think you just said, but I kind of missed it. So I think you had about 200 patients in shield, two and 40 with a large incision so implies about 20% with the appropriate criteria is that accurate.
So all good morning, Robin Yeah. So first yes. This is right.
We had about 20% of the shield to meet.
Meeting the pre specified criteria or the more focused population that we are targeting and show two I'll just remind everyone that shell to a recently had a broader eligibility criteria. It wasn't just open abdominal colorectal, but also minimally invasive.
It makes sense that you wouldn't see the same ratio of large you can see here that we've seen in shield one.
And this is why insured one we had around 45% of the patient.
Longer incision, and then show too with the 200, it's about 20%, but now that we are focusing the trial based on the FDA feedback we expect to see this number.
<unk>.
Now you add another point that you wanted to cover Roy.
They're together.
That's right.
Yeah, Yeah exactly.
So same same type of surgery.
<unk> population that we hadn't shield two we're just focusing on the subgroup. The prespecified subgroup that we had in shield, one which was the longer incision, where we received a P value of 0.0032 and also discuss this with the FDA and the FDA.
It is a supportive data and recommended that we add additional data focusing on this group.
Okay, great. Thank you and then a couple on the interim you don't Shield one you had a max enrolment.
Threshold does that also apply for the futility for them.
Unblinded interim and she'll too and you mentioned some some blinded assessments prior to the unblinded assessment.
Do you have a sense of when you can expect the first blinded assessment to occur.
So those are first of all there is a the blinded assessment are done.
Internally on an ongoing basis.
There's no real point to do that.
Until the point that we have sufficient.
Sufficient patient, where we can actually get some understanding but this is something that it was done in shield, one and will be done and she'll do on an ongoing basis.
It's something that helps us.
See that we are within the statistical plan within the underlying assumption. Obviously, there is no blinding here so nothing about the effect, but an idea about the overall management of the trial and that things are.
Well with regards to the interim.
We do have in the interim the possibility to have a sample size reassessment I think.
It is.
Early to go into those detail because the blinded assessment of what we are doing is around the ssi well I would say the primary endpoint the understanding of the primary endpoint the first offer role versus our underlying assumption and once we'll start to see.
See how this is progressing we can discuss in more detail, but we do have the possibility if needed to have a sample sizes.
Estimate.
Okay, great. Thanks, I'm, sorry, a couple more that you had partnering discussions ongoing.
For duplex 100, previously or are those pretty.
The much continuing.
If you kind of have to hit reset with the shield one data and then what about uncle plaques, but you know what about partnering that seems like it's going to be kind of on hold for a year or more.
Deal with duplex 100 is that true or any way to get that advanced maybe more expeditiously. Thanks.
Uh huh.
I'll start with the.
The latter part of your question our top priority right now is obviously the blocks 100.
But we are fully intended to continue the development of phone complex and essentially also other products in our pipeline and it remains a priority.
What we have done.
Up until now is developing the CMC processes and as we continue our effort to begin clinical development. This will be a very.
Valuable asset to get to the stage I think another thing that is.
Quite.
And a good stage is the preclinical package, obviously, we will need additional talks started to go into the clinical stage, but this is a priority, but youre right as I said before our focus is duplex 100. So obviously the resources that are invested in on complex.
And the mayor.
There are limited.
And I can add on the on the duplex partnerships.
All of the conversations that we had in the past we're still in contact with all of these potential partners is actually a few nuanced comment from other geographies that showed interest in <unk>.
In a partnering for different.
<unk> territory. So this is ongoing.
Obviously, a lot of it will depend on the trial, but no one no one really stepped back and lots of interest in the product.
Great. Thank you.
I would add to that one thing which is they do the new thing that we're seeing with the robust data and robust clinical data that we have from shield one is a better understanding and some additional interest around our platform around <unk>.
Collaborating around the <unk>.
<unk> pairing it with <unk>.
<unk> or known molecules in different area and this is very encouraging for us.
Okay very good thank you.
Thank you there are currently no further questions I will hand, the call back to you.
Thank you for joining polyp at fourth quarter and year end 2022 financial results conference call I would like to emphasize a firmly we continue to believe in our long term prospects, especially the potential of a promising late stage product candidate <unk> 100.
We remain grateful to our team members and all of our external partners for their commitment to our mission and their support and continuing to advance towards achieving our goal of bringing the duplex 100 to health care providers and patient as quickly as possible. We look forward to speaking with you.
You again on our next call.
Thank you. This concludes today's conference call. Thank you for participating you may now disconnect speakers. Please standby.
The conference will begin shortly to raise and lower Johan during Q&A, you can dial star one one.
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