Q3 2022 PolyPid Ltd Earnings Call
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
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Yeah.
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
[music].
Yes.
Greetings and welcome to the Polyped third quarter 2022 conference calls at 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 todays conference. Bob you did from lifestyle Advisors must do you did you.
May begin.
Thank you all for participating in <unk> third quarter 2022 earnings conference call.
Joining me on the call today will be quite shocked Aqua abroad, Chief Executive officer of <unk>.
<unk> workshop.
<unk> operating officer for U S operations.
Earlier today, the company released financial results for the three and nine months ended September 32022, a copy of the press release.
Is available in the investors section on the company's website www dot.
Dot com.
I'd like to remind you that on this call management will make forward looking statements within the meaning of the federal Securities Laws. For example management is making forward looking statements when he discusses our ongoing clinical trials and the timing thereof.
Our expectations to extend the company's cash runway into the third quarter of 2023.
Our attention to publish important results from the shield one study in a medical journal as soon as it is practical.
Top line results indicate that patients undergoing complex surgery with large institutions or patients with risk factors.
Essentially benefit from duplex 100 or.
Our attention to use the impressive data from shield one in discussions with potential partners regarding future pipeline products.
<unk> in oncology.
Our belief that significant reduction in superficial on deep FSIC and large surgical abdominal colorectal wounds and in high risk patients as well as the safety data are very encouraging.
Our intention to discuss with the FDA the lower than anticipated overall infection rate in this study.
Even by COVID-19 safety restrictions that were in place Waller trial is being conducted our.
Our intention to discuss the regulatory pathway for duplex for 100 for the prevention of Ssi and abdominal surgery with E with U S and EU regulatory authorities in the first quarter of 2023.
And the potential of duplex 100 to prevent Ssi and abdominal surgery.
The potential the innovation behind our lead product and preparations with advanced pharma and discussions with other potential partners and the potential outcome.
Of our anticipated meeting with the FDA.
And EU regulatory authorities.
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, which could cause actual results or events.
To differ materially differ.
You should not place undue reliance on such statements.
Encourage you to review the Companys filings with Securities and Exchange Commission, including without limitation, the Companys form 20-F, which identify specific risk factors that may cause actual results or events to differ materially from those described in forward looking statements.
<unk> disclaims any intention or obligation except as required by law.
To update or revise any financial projections or forward looking statements, whether because of new information future events or otherwise.
This conference call contains time sensitive information and speaks only as of a wide broadcast today November nine 2022.
A copy of the slides the management team will review on this call can be found on the investors section Poly peds website at investors Dark poly peed Dot com.
While the complete with the completion of those prepared remarks, it's my pleasure to turn the call over to Declutter cockpits ox abroad CEO of policy Deepa.
Thank you Bob on behalf of our team, which policy I would like to welcome everyone to our third quarter 2022, earning calls.
Im pleased to have the opportunity to provide you with a corporate update today during such an eventful period for <unk>.
I will begin with a discussion of the topline results from the shield one phase III study of the quick 100 for the prevention of surgical site infection.
The size and abdominal surgery, which we announced in early September beginning with slide three as a reminder, shield one the largest study of infection prevention colorectal surgery over a decade is a perspective global randomized double blind phase III trial designed to assess the efficacy and safety.
It looks 100.
This created along with standard of care compared to standard of care alone arm.
<unk> of post abdominal surgery inpatient all infection.
Larry endpoint of the trial is the combination of seasonal exercise mortality and surgical re intervention.
The site or won't complication and terminated by blinded and independent Adjudication Committee.
In 30 days post surgery.
A total of 977 patients were randomized into the study consisted of 488 subjects in the <unk> 100 treatment.
489 patients in the control of the study was well designed and well executed as it was balanced on all baseline characteristics and demographics.
Importantly, the trial took place during the COVID-19 global pandemic with the first patient to be quicker in July 2020, and lasting May 2022, we believe the precautionary measures put in place in the hospital during this time.
Overall infection rate.
This cautionary measures included a reduced number of surgeries being conducted this allowing visitors and increased personnel and hospital hygiene practices.
Believe that these critical external factors significantly impacted.
The trials statistical plan.
On slide four.
Take a closer look at the study population.
FDA request, a pre specified subgroup analysis was done based on a decision like.
The circle on the left indicate that 43% of total study subjects.
<unk> complex surgeries with larger decision the middle circle shows that nearly 70% of the total patients in the trial at least one personal risk factor is.
<unk>, a BMI over 30 smoking or COPD diabetes, and hypertension of significant each of these risk factors has the potential to increase the risk for exercise and other post surgical complications.
The circle on the right demonstrates that more than three quarters of the total study subjects, which active patient.
Let's move on to the top line results on slide five.
As we previously reported in the intent to treat population the local administration of <unk> 100.
Standard of care and 485 patient, which resulted in a decrease in the primary endpoint of 23% compared to standard of care alone in 14, 480, 90 subject, representing a P value equal to zero point alongside.
However, in a pre specified subgroup analysis.
Requested by the FDA of a total of 402016 subjects, which incision lengths greater than 20 centimeters. The local administration of <unk> 100 resulted in a statistically significant reduction of 64% in the primary endpoint compared to standard of care alone.
Representing a P value of 0.0032.
As I highlighted on the previous slide this statistically significant reduction was achieved in a large subgroup representing over 43% of the patients in the intent to treat population.
Since the initial top line readout was announced.
We have continued to gather and analyze additional data functional decline.
This data has been increasingly encouraging while we cannot get too granular at this time as we intend to publish this important result in a medical journal as soon as practical.
Would like to highlight.
A post hoc analysis duplex 100 also demonstrated a clinically important reduction of debt.
34% in the primary endpoint in high risk surgical patients.
With at least one personal risk factors, representing a P value of <unk> workforce statement.
Now, let's take a deeper dive into the large institution subgroup on slide six.
Most importantly, we see a large effect size in all efficacy.
Highlights the decrease in the first two secondary endpoints were the infection rate 30 days post abdominal surgery with 10% in the standards of care.
Versus 4% in the district 100 treatments I'd also point out the lower mortality rates in the next 100 treatment.
As well as significantly fewer patients treated with IV antibiotics as treatment for adjudicated attacks.
So to conclude on the secrecy aspects of the trial, we believe that the top line results indicate that patients undergoing complex surgeries with large infusion of patient with one or more risk factors could potentially benefit from this X 100.
And as you can see on slide seven.
100 showed good safety profile in the shield one.
All significant there was no impact on mortality in the duplex 100.
Compared to the standard of care. In addition, there was 40% reduction in surgical we intervention in the duplex 100 treatment versus standard of care.
Also severe treatment adverse events occurred in 12% of the patients receiving <unk> 100.
16% in the standard of care arm.
Serious treatment adverse events occurred in 14% of the patients receiving the six 100.
22% in the standard of care alone.
Moving to slide eight.
It is important to highlight how the overall result of shield one truly validate the ability of our proprietary flex technology to locally deliver treatment over a prolonged period of seven period with minimal systemic exposure.
PK data collected in the trials showed very low concentration of doxycycline in the plasma.
Longer period of 30 days as designed we intend to use this impressive data in discussions with potential partners regarding future pipeline products, including in oncology in summary on slide nine while the overall top line results for <unk> 100 did not meet the study.
Typical assumption.
Significant reduction in superficial and deep exercise in large surgical abdominal colorectal wounds and in high risk patients as well as the safety data. We believe are very encouraging.
We are in the process of preparing a package of data from shield one trial positive phase two study.
For submission to the FDA and intend to discuss with the agency the lower than anticipated overall infection rate in the study.
Driven by COVID-19 safety restrictions.
In place, while our trial was being conducted.
As previously stated we expect to meet with the FDA regarding the regulatory pathway to get quick 100 for the convention effective starting with Domino surgery in the first quarter of next year.
We plan to meet with EU regulatory authorities shortly thereafter.
Based on the totality of the data generated to date, we remain confident in the potential of <unk> 100 to prevent a domino effect.
As we approach this anticipated meeting with the FDA. It is critical to contemplate a few potential outcome. For example, the FDA may potentially agree the data could be sufficient for seeking approval.
Narrower patient population based on the current collective business.
The FDA could require us to conduct another clinical trial or generate additional data.
If we were to conduct another pre approval trials, we currently believe that.
This would be a smaller more targeted.
Also from a regulatory perspective, we were pleased to recently received confirmation from the European Medicine agency or EMA.
<unk> 100 is a larger bulk for submission of marketing authorization application in the EU under the agency centralized procedure.
Centralized procedures allows the submission of a single marketing application to the EMA that if approved in April the product to be marketed in all EU member states as well as in Iceland, Liechtenstein and Norway.
Centralized process for legibility is granted to date with 100 under the Coke Classic innovation criterion, which underscores the deep look 100 provides a new innovative alternative to patients presenting abdominal exercise.
On a related note I think it is important to also highlight that we proceed with our regulatory preparation with our European partner advance pharma.
In addition, we remain engaged in partnering discussions in multiple additional geographies pretty quick 100.
Of course, it is unlikely that we will enter into any additional partnerships prior to the receipt of regulatory feedback.
I would now like to provide a brief update on.
I'll lead into a tumor on product candidates in oncology applied as it paced tumor resection area doing surgery.
On complex remains a priority for policy and we are currently finalizing CMC processes.
We continue our efforts to begin clinical development for this promising product candidates.
Moving on as you know, we recently announced the cost reduction plan, including a 20% decrease in head count across all day parts.
As we prepare for our planned regulatory interactions regarding this X 100 early next year, we expect that these decisive actions will extend our cash runway into the third quarter of 2023.
And further enhance the company's long term growth strategy.
That is a good transition to now move into a review of our current financial.
As of September 32022, the company had cash cash equivalents and short term deposits of $18 $1 million, which includes the $2 $6 million upfront payment from advanced pharma received in the third quarter.
So as it relates to our balance sheet during the third quarter of 2022, we sold approximately $600000 worth of ordinary shares from our existing at the market facility.
To reiterate we expect our current cash runway will extend into the third quarter of next year.
Now, let's turn to our income statement research and development expenses for the three months ended September 30.
2022, or $6 2 million.
<unk> to $7 3 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.
Yes.
Marketing and business development expenses for the third quarter of 2022 eight.
$840000 compared to $445000 for the same period of 2021.
General and administrative expenses for the third quarter of 2022 or $1 $7 million compared to $2 1 million.
Recorded in the prior year period.
The third quarter of 2022, the company the net loss of $9 3 million as compared to $9 9 million in the prior year period.
We will now open the call to your question operator.
Thank you as a reminder to ask a question you will need to press star one on one on your telephone keypad start one on one to ask a question I'm. Please wait for your name to be announced.
We will now take 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 I appreciate all the color today.
I'm not going to get.
Just any color if there's precedent to get a sort of enable pad for a certain size and decisions about 20 centimeters with it in the U S or ex U S. And then how do you can get extra commercial opportunity I could see it sort of playing out first.
It gets on formulary and maybe gets used up a little bit more broadly or maybe stay the formulary. So just any color in terms of your market research at this stage.
To get sort of that narrower label, how do you think that may play out in practice. Thank you.
Thank you, Brian and good morning, I will start and I'll, let ori elaborate more on the commercial opportunity.
In terms of the labeling our first discussions coming discussion with the FDA regarding the regulatory path and the path for an NDA labeling will be discussed on a later stage, we do see them.
Very nicely with the <unk>.
If you for example look at the <unk>.
The negative one pressure that the labeling is around.
Prevention of.
Oh hi.
How they differ.
One complication they referred to want complication. So you do see that for example, if you look at her onto aquatic the expansion of the indication that was granted I think it was.
Around may or June last year.
The labeling is referring in their case to.
Small to medium seizure, so they referred us to the restaurants to length of decision does exist.
For us it's a.
It's the next step we first want to make sure that a we have a clear regulatory path for NDA submission, but definitely this is something that we are evaluating and we will be discussing with the regulatory but you do see as I said is two of the off My head example, you'll see references.
In this line.
And maybe I'll take the.
The commercial opportunity.
I think first.
Maybe generally we need to understand that.
The strike was done during COVID-19 and even with Covid, we see almost almost across almost 20% infection rate in this high risk groups, one on one and six one in five patients.
So you can.
You can see how this can extending even be even even broader implications once.
Hospital Couldnt go back to kind of let's say <unk>.
This line ought to normal operation.
When we looked at in market research actually earlier this year, we ask doctors.
Their processes, how do they look at patients what do they see doctors now.
Doctors know before the operation which patients are.
They're high risk, which operations will be more and more complex, which patients are more comfort infection. We asked them and we ask we asked them to assess kwan.
<unk> quantified this.
This part of the population in abdominal surgeries.
Which was actually a little bit surprising surprising to us it's 40% of surgeries are patients with that are that are high risk and the way. We the way you want to look we want doctors surgeons to look at our product is one more tool in their toolkit when they think of the prophylaxis when they think of.
Okay I need to.
Do whatever I can to prevent infection in this high risk group now they have another another.
Tool in the toolbox that showed a 50% reduction in complex surgeries.
<unk>.
Similar similar trends in the in the high risk patients. So overall I think there's a <unk>.
The starting point here of course, the plan has always been from the beginning let's get the approval and then generate more data and expand expanding tool into a broader label.
And we believe that with <unk> going away and volumes in our hospitals going back up and kind of returning to baseline. We will see we will see the need just growing more and more.
Thanks, very much I appreciate the color.
Thank you.
Thanks Keith.
We will now go to our next question.
One moment please.
Andrew next question comes from the line of Elliot Wilbur from Raymond James. Please go ahead.
Hello Eliot is your line on mute.
Yes can you hear me all right.
We could add.
Okay.
Good morning, good morning.
I wanted to ask a question about the.
Additional.
Post hoc.
Data that you presented today and.
Subpopulation with with one or more <unk>.
Risk factors.
I mean, it looks like that is in isolation independent incision size and then I just wanted to confirm that and.
I'm just thinking about the interaction of the.
The two categories if in fact you.
Look at data with large.
Large decisions.
With the additional.
Inclusion criteria of having one or more.
Risk factors. So just wanted to get your your thoughts on on that idea and then for already perhaps just thinking about some of the <unk>.
Additional secondary data points that have been.
Presented.
It seems like quite a few of those are going to resonate well with with.
With payers on the commercial side, but just wondering if you think any of these sort of stand out or maybe more.
More favorable than original expectations headed into the trial.
Specifically thinking about number of.
Re interventions.
Post.
Posted vectren or number of subjects treated with the <unk>.
Antibiotics in order to adjudicate exercise, but just any thoughts on some of the additional secondary efficacy endpoints that you think will resonate really well on the payer side. Thanks.
Thank you Elliot so with regards to the head of <unk> regarding our risk factor you are correct.
Great and its a separate group at 70% by the way.
If the patient population.
This trial.
It has.
One patient related risk factor.
The.
Complex surgery with long incision is about 43% of the patient population in the trial. So of course, there is some overlap.
Quite significant overlap because in many cases, the patient that are requiring more complex surgery also have risk factor.
Most of the patients in the trial had at least.
One patient related risk factor, but those are two different analysis.
I can tell before I turn to or is it in general.
Yes.
The largest phase III in abdominal colorectal done in over a decade. There is so much data towards gather both in terms of medical relevance health economics, as we said in our.
Today's prepared remarks.
We can't get too granular about things because we do plan to publish it.
In a medical journal or more than one Archie call, but we wanted to give a sense.
So investors and analysts since this is the first call since we published the topline.
How much.
Formation and how much data is being gathered seeing and give the understanding of where we are focusing both our discussions with the regulator as well as with our partner and potential marketing or you want to follow through the checkpoint.
Hi, Alan.
For on the.
What im looking at I think as a whole is around the complication and I think this is the message that we're really resonate with the hospital.
Reducing complications and time in the hospital and this is kind of.
A collection of what you mentioned is re interventions.
And IV antibiotics in time at the hospital and Readmissions and although this data a lot of this data we're still we're still working on so in and some of this data.
We will need to further.
Investigate but I think I think there is a nice trend here around.
The wound complications.
Another thing Thats actually declined and I were talking earlier today.
With this complexity you can see you can think of impact from pricing for example.
There is.
The high risk group is that.
Uh huh.
Somewhere from the manufacturer, there's maybe an opportunity here to look at.
It's more.
More expensive products here so.
Few things, we're looking into a run around this data.
Yes.
Thank you.
We will now go to our next question.
While mainland piece.
And your next question comes from the line of the loyalty from Barclays. Please go ahead.
Good morning. This is actually <unk> on for <unk>, but thank you for taking my questions. You mentioned you're engaged in partnering discussions across multiple additional geographies I'm wondering if you could provide a bit more color on what we can expect here and really just a key criteria youre looking for in additional partners. Thank you.
So thank you and good morning, as we also said in our prepared remarks, we are continuing the discussions that started prior to the topline surprisingly for US all of those discussions are continuing.
We're very clear to say and we don't think it's in our best interest before we have further clarity on the regulatory pathway forward to go into any.
Final discussion even and.
Just to reassure the interest and the continued interest and the unmet need I think thats.
Already mentioned it a bit.
In his previous answer but.
If investors and listeners and stakeholder really think about it.
Duplex was tested in the best.
Condition.
It may be ever existed for a hospital or a surgery best in terms of hygiene best in terms of.
Yeah.
Overloading the hospitals, there was never before such a period that.
Surgeon hospital patient had this.
Extreme the cautionary measure and still in this condition, especially in the complex surgery and.
With the lung incision, you see an overall reduction and this is.
Indicated in slide five you see an overall reduction in the primary endpoint from 18% to eight.
So.
Companies that are focusing on this area.
Are very much engaged and interested I think that's it.
Early to set expectation here.
And we think it's in our interest to first meet with the FDA.
<unk> said before this is planned for the first quarter of <unk>.
Next year and only after that we can.
Mike.
Better assessment.
What's the path forward in this discussion.
Thank you.
We will now go to our final question for me.
And your final question comes from the line of <unk> <unk> from JMP Securities. Please go ahead.
Hey, Thanks for taking my questions.
Got a few I guess the shield two does that remain in slow mode pending the regulatory.
Meetings and have those meetings actually been scheduled for the first quarter. It sounds like you have an agreement from the EMA that you can submit the MMA. So I guess, what do you need to get out of the meeting at <unk>.
So let me.
So let's start with the last part what we got from the EMEA is a very liquid too.
Pat.
Centralized process, it's not yet any.
Indication of what they were how they will evaluate the data or how they will review.
So setting the in today's release after second meeting with the FDA. Shortly after we intend to meet with the European authorities for again for an advisory meeting.
Once we follow that we will have the option to then approve the product in a centralized procedure, which will enable us to get an approval at one time and we will not be required to go country by country, but this is not really an indication on on the pad.
<unk> forward in terms of.
Actual approval, but just a very.
Liquid processing defense that is granted to products that showed innovation and strengthen.
Our understanding on how they view the results that we've submitted from the phase two as well as the innovative chi that depicts the suggest in the anti infective space, So that with the European authorities as we again, we said.
In the prepared remark we are now in the process of preparing the package.
We are in the last stages of preparing it and intend to submit its quiet in the next few weeks and knowing the time frame that is required required from the time, we submit the package to have a meeting.
Im confident that we can meet with the FDA at the first quarter of next year, but.
To answer your question there is still not a specific date.
Okay great.
While you also without <unk> so yes.
You described it correctly, it's in a very low key mode waiting for clarity on the path forward and then we will decide if we can use this infrastructure.
Be converted into a post approval, we'll need to decide once we know.
What's the path forward.
Alright, great and sorry, maybe I missed it but what how do you estimate the proportion of <unk>.
Colorectal surgeries in the U S that have a decision larger than 20 centimeters, but I think there was a directive in shield one to use two vials of duplex 100 <unk>.
With larger than 20 nanometers, I believe was that followed and is that a.
Possible explanation for the superior results in that group basically a dose effect.
So I'll start with the second part and Ari will relate to the first part.
<unk> it is not specific to this trial the dosing.
Domino surgery.
Based on the length of the incision.
<unk> consumer.
<unk> value proposition moving onto 10 to 22 vials are required and over 20 centimeter is 80.
<unk> three vials that administrated.
We did not see any indication at this stage that there were a dosing issue.
And we don't believe this is the case, we do see and if we need to explain based on the information that we have now on why there wasn't a statistically significant or in fact statistically significant effect in the lower <unk> seem to.
Me too.
What we think is that the best explanation to for that is that because of the various.
Cautions that measures that we're taking viewing coffee.
Overall infection rate in them.
Standards of care with very very low less than 5%, which we haven't seen.
<unk> reported in the abdomen open up Domino colorectal resection prior to that and this really creates a situation where there wasn't enough.
Enough events to show a statistically significant effect.
And maybe just.
Your question on the market so what.
What we looked at in the past one I mentioned before is.
The complexity or the risk for infection. This was part of the market research and this was.
40% of patients coming coming into colorectal resection.
Well Oliver abdominal surgeries, but colorectal was very much in that same may stay.
Same numbers.
We're now looking into into these larger decisions. This was this was a group that we did not look previously market research. So so we're looking into that as well, but again just to reiterate this in any case. This is this is the starting point this is the.
The initial label approval and we'll build it will build.
Extend the label from there.
Okay. Thank you.
Yeah.
I will now hand, the call back for closing remarks.
Thank you for joining our third quarter earnings conference call I would like to emphasize our firmly we continue to believe in our long term prospects, we remain grateful to our team members and all our external partners for their commitment to our mission and their support in continuing.
To advance towards achieving our goal of bringing <unk> 102 health care providers and patients as quickly as possible. We look forward to speaking with you again on our next call.
Thank you. This concludes today's conference call. Thank you for participating you may now disconnect.
Okay.
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