Q4 2020 PolyPid Ltd Earnings Call
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Welcome to your confidence call. Please continue to standby we have confidence will begin shortly thank you.
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Great teams and welcome to the party paid fourth quarter and full year 2020 conference call. At this time all participants are in a listen only mode. As a reminder, this confidence is being recorded I would now like to introduce your host for todays conference Mr. Bob.
Just eat from legacy at devices, instead, Oh, what was well you may begin.
Thank you all for participating in polyp grade fourth quarter and full year 2020 earnings conference call.
Joining me on the call today will be good jobs, because OXXO broad executive Vice President and Chief Financial Officer colleague pit and Doctor know him Manuel.
Founder and Chief Scientific Officer.
Earlier today, probably paid released results for the three and 12 months ended December 31 2020.
A copy of the press release is available on the investors section of the company's website.
I'd like to remind you that on this call management will make forward looking statements within the meaning of the federal Securities laws.
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 SEC filings.
Results may differ materially from those projections. These statements involve material risks and uncertainties that could cause actual results or events to differ materially Accordingly, you should not place undue reliance on these statements.
I encourage you to review the Companys filings with Securities and Exchange Commission.
Clothing without limitation, the company's forms F. One and 6K, which identify 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, 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 the live broadcast of the day.
Number 10 2021.
With the completion of those prepared remarks, it's my pleasure to turn the call over to Declutter Chalkpit day clock.
Go ahead.
Thank you Bob.
Our team at Poly Pete I would like to welcome everyone to our fourth quarter and full year 2020 earnings call.
I will begin today with an overview of our accomplishments in 2020, and then we will provide a detailed update of our business Dr. Manuel a founder and Chief Scientist Officer will review, our recent progress with our own complex oncology program. Finally, I will review our.
Financial results after which we will open the call for questions.
Unfortunately, I mean weisberg, our chief Executive officer, He's having a medical procedure and cannot be with US today, we wish them well and expect him to be back at work shortly.
As we enter what we expect to be an exciting year I would like to take a moment to reflect on what was truly a remarkable 2020 full policy.
Most importantly, we have achieved significant progress in advancing our development programs and in continuing our solution towards becoming a commercial company.
Our phase III program for <unk>.
Lead acid duplex 100 for the prevention of surgical site infection or society is well underway. Our ongoing shield one trial is enrolling well and our second phase III trial and abdominal surgery Shield two was recently initiated.
We are thrilled to have both phase III trials now open and enrolling patients in the U S Europe and Israel next.
The execution of these two clinical trial would it be a core focus for policies in 'twenty 'twenty one.
A reminder, these two phase III clinical trial will serve as the basis for policy its first new drug application or NDA submission.
Beyond our lead indications. We also have an ongoing clinical development program for duplex 100 for the prevention of pesticides in bone tissue, such as the Sterno and open heart surgeries. In addition, a promising on complex local intra tumoral therapy preclinical program for.
Which we recently announced promising preclinical data.
<unk> continues to advance as planned.
From a regulatory standpoint, we were excited in the fourth quarter to have received breakthrough therapy designation, but it takes 100 from the FDA for the prevention of exercise in patients undergoing elective surgery.
It looks 100 previously received two fast track designation from the FDA for the prevention of post of Domino surgery institutional infection and for the prevention of Sterno wanted fiction post cardiac surgery as well as to qualified infection disease program designations or acuity piece.
The same indications.
We closed the year by hosting a well attended K well called multiplex 100 that featured presentation by Dr. Social shops of the Mayo Clinic Doctor Anthony Senegal, formerly a few T M B at Kevin Stone and therefore, that's more a function of your medical Center, Israel, who it is.
The burden and challenges related to exercise enforced colorectal and cardiovascular surgeries and the opportunity of day, plus 100 to change the current treatment landscape.
Poly Pizza robust ongoing development program for our innovative flex technology is supported by a strong balance sheet, which was father strengthened by the successful completion of our IPO on the NASDAQ in June 2020.
We raised 62 8 million.
Net proceeds from the IPO and added several other well respected new investors. We continue to expect that our current cash position will be sufficient to complete the shield, one study and to conduct she'll too as well as per for the submission of an N D. A to D. F D. A.
Let's shift gears and I would like to provide a brief discussion on the status of our pipeline.
Following the enrollment of our first patient in the shield one trial.
July 2020, and the initiation of the shield to trial in December we have continued to open clinical trial centers at an impressive pace.
I'm pleased to report today that we have now enrolled a total of 100 patients in our two phase III studies with the vast majority of those subjects in our ongoing shield one trial.
As we have said previously for shield one our plan is to enroll 602 900 patient within 60 centers in the U S EU and Israel.
Following the enrollment of 500 patients to study design provides for a blinded sample size re estimation based on the overall infection rate well preserved in the study in order to determine final target enrollment for this study.
We continue to anticipate the top line results for shield, one will be a valuable by year end 'twenty 'twenty one.
Late in 2020, we were pleased to initiate shield, two which has brought the eligibility criteria, including minimally invasive surgical procedures.
This is important because it will provide additional clinical evaluation of the potential of duplex 100 to prevent exercise in broader surgical population.
<unk> trial will enroll approximately 900 to 1400 patients across the same number of centers is shielded one enrollment and shield two is advancing as anticipated.
From a commercial perspective to reiterate what we have said previously in order to maximize our commercial success, we have begun to establish our own footprint in the U S to initiate commercial preparation activities, while also exploring potential partnering opportunities.
With leading pharmaceutical companies, we are in discussion with.
Potential partners for the U S EU and Asia market in the U S. We are thoroughly evaluating the market access and reimbursement landscape as well as key hospital economic buyer of matters to ensure optimal positioning and coverage of Triple X 100.
As part of this work we are conducting extensive market research with surgeons pharmacies and hospital administrators to further assess that attractiveness of the flex 100.
This research will help us identify critical opportunities and any potential challenges to adoption.
Two of those initiative in our clinical trials. Our goal is to generate data that demonstrate positive clinical outcome for duplex 100, as well as favorable health economics for hospitals to drive the commercial potential of <unk>.
Our drug candidates.
For the prevention of pesticides bone tissue as you know we initiated a phase III bone motto trial, an open heart surgery earlier last year, we focused on bone tissue due to the high risk of morbidity and mortality in cases of deep surgical site infection in these procedures.
We are currently evaluating next clinical steps for an open heart surgery phase III trial, while we ensure that.
The shield, one and shield two trial continues to progress as planned.
The company intends to submit the bone surgery data as a supplement after the approval of the NDA for abdominal soft tissue surgeries.
From a regulatory perspective, we received breakthrough therapy designation for duplex 100 from the F. D. A for the prevention of assist site and patient undergoing collective colorectal surgery.
All significant breakthrough therapy designation for anti infective drug is relative to raise and we believe is indicative of the urgency to adopt new innovative therapies to prevent surgical site infection. It is also important to note. The breakthrough therapy designation is granted.
Based on preliminary clinical evidence, indicating that the drug may demonstrate substantial improvement over.
Other existing therapies.
One or more clinically significant endpoints.
At this point I'd like to turn the call over to norm, our Chief scientist officer to discuss our own complex program no I'm sorry.
Thank you declare it is my pleasure to join this quarterly call, especially before the only thing from what they've kols calls and which I, particularly.
We tweak here was in mid December.
Is it big Crunch I'm, the founder of party and serve as the Chief Scientific Officer.
Now I would like to further elaborate on the potential of a phone complex.
Intra tumoral chemotherapy product candidate to overcome to move including those with other chemical resistance.
Complexity of controlling the local exposure will still move says to the setback true one of the most widely used chemotherapy agents.
Yes.
As you know systemic Cumulus therapeutic treatment is significantly limited.
The other keeping solid tumors, mainly due to the limited penetration and the high toxicity to non involved tissues.
Complex utilize the pellet piece, there's no other flex technology to provide prolonged and controlled local exposure to Docetaxel and then 12 operated with Jim always fiction setting.
The control over the exposure to chemotherapy will have created an impact from both the efficacy and the safety of the treatment.
The release of the drug is immediate.
Surgery, and Couldnt see new other weeks to follow with minimal systemic and toxic exposure. These.
These combined attributes may become critical to overcoming Puma real cash and to prevent the spreading of costs.
During the post operative period.
You'll recall that late in 2020.
Positive preclinical data from this program.
The thing I think most models fulfill if you move of colon carcinoma using council says Hey, there was this thing to docetaxel amongst the most treatment resistant Cumulus sales type of single local application of a phone complex generated significantly better results compared to the group III.
With fixed side, because the systemic docetaxel treatment in multiple key measures, including overall fuel moving.
Although survival and overall GMO free survival.
Based on these compelling preclinical results.
Ken what therapeutic resistant tumor model, we intended to conduct additional clinical safety studies, all phone cookbooks inverse type of solid tumors and other too.
To complete preclinical package for the finding of free I N D meeting request with the FDA later, this year and potentially initiate the phase one clinical trial.
2022.
We believe wound complex could have the potential to become part of the standard of care and there was section setting with multiple cancer types, including Glioblastoma prostate cancer and head and neck cancer.
With that because that will now review our recent financial results.
Let's start with part of Pittsburgh sheets information as of December 31st 2020, The company had cash cash equivalents short term and long term deposits of $66 $6 million as compared to $26 $6 million as of December 30 <unk>.
First 2019 cash.
Cash used in operations for the 12 months ended December 31st 2020 totaled $22 million, we expect that our current cash runway will extend into 2022.
We believe our strong balance sheet will allow us to complete our first phase III trial shield, one and abdominal soft tissue infections.
To conduct the second abdominal surgery study should too and to prepare for the submission of an NDA.
On another positive note policy. These very proud that other companies share as of December 2020, we're helped by the arc Israeli and other technology ETE. If this is one of the active funds managed by catchy would well known investor who founded Ark investment management.
Now, let's turn to our income statement.
Research and development expenses for the three months ended December 31st 2020 were $5 million compared to $3.3 million in the same three months period of 2019.
Spending increased due to day initiation of the phase III shield, one and shield two clinical trials.
General and administrative expense for the fourth quarter of 2020 with $2 2 million compared to 800000 to the prior year period as cost increased due to being a publicly traded company with higher.
Insurance costs, and an increase in noncash share based compensation.
Marketing and business development expense for the fourth quarter of 2020 was $700000 compared to 300000 dollar for the same period of 2019.
The spending increase is mainly due to an increase in marketing and business development personnel.
New offices in New Jersey, and an increase in market.
Seek activities as we start building a commercial infrastructure for the fourth quarter 2020. The company had a net loss attributable to ordinary shares of $7.3 million compared to six $9 million in the prior year period, we will now open.
The call to your question operator.
Okay.
Thank you so much as a reminder, please if you wish to ask a question to start a while under telephone and wait for your name to be announced if you want to go from just request. Please press the husky. Thank you and the first question comes from the line of.
And with me one second guess the first question comes from the line of.
Elliot Wilbur from Raymond James Please go ahead.
Hi, guys. This is actually Michael or Elliot. Thanks for taking my question. So two main one for you guys.
First one going on on the basis of R&D and SG&A.
How should we look at spending over the course of 2021 or is it going to be in line with 2020 levels and is it expected to peak at any particular.
But in time throughout the year.
And then second question on the uncle Flex program. The Phase. One studies are you guys expecting to conduct other than any specific tumor type or is it just general solid tumors and then.
Hum.
Sure going to be using.
Dr attached so or are there any other taxane or chemo agents that we should be considering thank you.
Okay. Thanks, good morning.
Well go one by one with regards to our research and development expense.
We expect to see some increased.
As we recruit more patients as you might recall, we started the phase three the shield one.
And the second one in December.
Won't be the price when we.
Of the two trials running so we do expect them to increase and this is budgeted we don't see profit increase the expected increase day.
Hey, just the fact of being at full force.
For your other publicly traded company.
Debt to the last two quarters out quite are indicative of the coming year, but we do expect that increasing day rates there shouldn't be that effect.
To reflect day.
But still we are very comfortable with other statements in today's press release, the sound cash position makes its way from St.
You too.
While you're running those two trends with regards to the uncle place.
And then two as you are.
Asking two questions with regarding to the <unk>.
Ken standard, we will be conducting trial and the second one was with regarding to the toxic between won't be using so in terms of we said very clearly that we expect to meet the F. D. A.
For pre IMD meeting and start phase one.
Following you.
We have seen very nice results in our preclinical data support it.
The approach could be you are seeing that.
Cancer types.
And what we are targeting.
Sure.
At this stage.
But we do see a potential for more than one humor, and we'll need to see based on that.
Yeah, what is the best strategic approach in Tampa.
Whether it's to focus on what tumor debt expense on hand or have more of what the FDA is called a bundle type of thing.
This will check mod in lung cancer.
Still we remain to see non would you like to add.
Yes.
Yeah, I would add that we selected those attacks.
Using dos attacks.
Income tax although it can be.
From drugs.
Lexicology because other banks it is a very wide activity against many of around 4007 from other type of cancer.
It has a mechanism of friction against this type of approval.
This is very very standard.
Good day.
So with that it should be effective again.
These are tools.
We are going to mention the main channel.
So they can be divided into several other type of tools.
And we believe.
Yeah that are we here.
We will decide together.
And how do we look for their debt and how it is divided that targets one of them or a growth from their bandwidth wearing kraus of fireeye for income.
So.
To discuss about what do you believe that don't come from.
You can see again right.
Thank you so much and the next question comes from the line of Gary Nachman from BMO capital markets. Please go ahead.
Hey, good morning, it's Rob Hey, Sagar on for Gary.
Could you comment on what portion of the sites are activated for both shield, one and shield two and specifically for shield. One could you talk a bit more about your level of confidence in the sample size re estimation still occurring in mid 2021.
You know how is the current pace of enrollment trending relative to your expectations and what kind of impact are you seeing from COVID-19 on enrollment. Thank you.
Thank you outside the morning, and you're right.
Very good point.
With regards to the number.
We have centers that are opening should what should we just don't have the same growth. So it's too early to.
Yeah.
Related to the number of centers, but we are very happy with in other words, a center that opened for sales.
We set a.
We plan to have 60 centers.
Place and a majority of the centers are open and <unk>.
I think that one other things that we've done.
Sure.
Does the trial work when Covid was already out there, but we have to do it that day, we might face some issues.
<unk>.
Our tweak decided to open relatively.
A large number of centers 60, and we've also.
Separated the centers book between shifts and share to those other different centers. So they are not competing in one another and we're not holding back any of their reports net.
But also ensure two of the plan is to have 60 centers and we've also assumed a relatively modest number.
The patient per center, one patient per center.
The average along day trial.
It is quite conservative.
With that we.
Oh very much confident that we will reach the 500 patient.
Wow.
Yeah.
Finalize their equipment before the end of day, yet so we are on track on that.
You know that the wall.
I think that's that unless we have other surprises we have quite close debt that we are on track.
Sure.
That's good for here that's good to hear thank you for that color.
Can you comment on what you are able to see.
In the blinded data for shield, one and specifically the overall rate of infections and whether that is trending in line with your expectations.
I can only say that debt.
Ali a week.
It's about a 100 patient overall and we do expect to be reporting them.
Rich patient a poor sales one separately, although the majority share, but I can't say that it is in line with our expectation.
Got it and then just.
Last one for me it would be helpful. If you could comment on.
Your key objectives in 'twenty 'twenty one.
Back to the market research and commercial preparation.
Much further do you plan to expand the organization over the next year.
So we are now cut back team.
Liked robust market research as we we said that would help us really evaluate again, if there's anything that needs to be.
They all tweets in advance.
Jan.
So this is a still in progress and we hope to be able to give some more color on the outcome of space as well.
Progress on the other hand, we said.
Quite clearly that the other day.
And we are in discussion with.
The pharma companies, but the defense market and we will continue with debt.
Our <unk> business.
Business development strategy that is clearly to put my.
For line duplex, one hardware with partners in Europe, and the rest of the world.
With top strategic partnering.
America, while having a book so we've increased our office and.
Okay stomach New Jersey.
This is positive day, increasing expenses that you see in day sales and marketing, but we will continue to do it in a modest way we are not ex.
Yes.
Extending our expense here without seeing data coming.
Thinks will be.
Accelerating one another so once we have the data out there, which we hope will be fine.
Every positive this will be helpful. Also in all other commercially discussion. So we are doing it step by step in terms of the expense, but we did increase the.
Person out there and we are spending more cash there in terms of our market research of the salary required in supporting the discussions and evaluation process.
Got it that's helpful. Thank you.
Just one more from me actually could you comment on.
Our current thinking around their assumption of.
The cardiac external trial, what would you need to be and move forward there and if that's something that could potentially happen. This year. Thank you.
So because we are prioritizing shield, one and show to the two other paths to an NDA, we don't want to risk our financial resources by expanding too much and we are also.
Adjusting the oncology program. So we are holding on debt to make sure we have the sufficient resources.
But in any case.
All indication is the plan to be submitted as a supplement to the NDA. This was to start with so it shouldn't hold us into the commercial.
Stage, but we will need additional as we debt.
I lost you will need additional resources in order to complete this trial.
Thank you very much and congratulations on the progress.
Thanks, you so much.
Thank you so much.
And now we will take our next question that comes from that I've also seen the Lee from Barclays. Please go ahead.
Hey, this is Cindy on fertilizer E. We just had a couple of questions are you guys. Seeing are you guys seeing any greater or in your Kols interest you guys continue to fly duplex potential and if there are any updates on commercial outlook based on any new insights you might have thanks for taking my question.
Good morning could you repeat the first half of your question, we couldn't hear you well.
Yeah. If you guys are seeing greater on your tail interest as you guys continue to book flag duplex potential.
Sure sure.
So definitely.
We see that by the way both from the surgeon to 12 with discussions with the hospital. So we see it in different area, we see it with the east too.
Get a surgeon to engage in hospital engage and being part of our share of launching two trial and the clear messaging.
I think this was also very nicely covered in our last kao elephant in the center.
But we also see it in discussions with the <unk>.
Pharma companies.
Thanks, that's helpful. And then if you guys could just comment on any updates for partnerships or licensing on plex matrix development or future commercialization.
So as our always in other industries very hard to comment on that as they are in process because those processes take a long time and there are different consideration that needs to be taken so its hard to comment on it.
Only repeat what we said this we are in discussion.
Our strategy to attract especially and we have also in that respect because of the need of Florida.
I mean, you know Osama from Jersey office with debt.
Personnel debt is coming from business development and sales and marketing.
Great. That's helpful. Thanks for taking the questions.
Thank you so much and I sort of remind us. Please if you wish to ask a question. Please press star one on just telephone and wait to put your name to be announced if you come since you went to come from your request. Please press the husky and once again, if you wish to ask a question. Please press star one and the next question.
Comes from the line of Jim Malone from Allianz Global Please go ahead.
Hey, good morning, guys. Thanks for taking the questions could you walk us through how you allocate between shield one verse shield two just on the just thinking that I know that shield, one potentially the data looks good enough.
Your final Bill right there in shield one alone.
So how did you how do you sort of got the algorithm to pick people Michelle to win when you know getting shield one dumps.
Soon as possible.
As potentially the fastest route to market.
So good morning to you and thank you. This is a good question.
It's quite simple in defense debt, we've separated the center. So we felt the same center. So what's a center is open it's either open for share of the one off.
For sure two so they don't have this dilemma whatsoever.
We have done we've opened first.
In fact as possible centers for sales.
Exactly because of what you just mentioned because this is the first.
That will end and potentially could serve as a.
Yes.
A trial for approval for the NDA that will be sufficient for approval and in Europe. It is it is sufficient so we won't we don't need for the European approval or we don't need any additional trials, but potentially also for U S. These could have.
Service day people tell trial for approval.
This is our priorities and we opened force sensors will shield one.
She was won is also up and running since July so we had even more time to open an <unk>.
To say that.
More than 50 per cent of the centers are recruiting patients.
Great. Thank you for that and then how will how would you guys know or how will us as outsiders looking in no debt.
You'll definitely be able to hit the fourth I think fourth quarter 'twenty one for shield one data.
And I guess also no sorry for that and then I've got one.
One final follow up question. Please.
Sure sure. So we as we promised in our last quarterly call. When he said we will update from this once we reach 100 patient and we have overall 100 patients in the next day and our next press release will be when we reach 100 patient and shows one which.
We'll probably be very soon from now.
No.
And we will continue to update that not every patient that is reported especially make sure that investors are aware of our progress and tend to evaluate where we stand in terms of recruitment we put a lot of air force on that internally and externally.
Our main objective for this year and the company is very much focused on debt.
I guess final question would be then would obviously you started in July of last year.
Most of the 100 in the first.
Trial.
These accelerated dramatically.
At what point will you know that exploration of <unk>.
It is happening and when will we know on the outside looking in.
Right.
The main.
Our hurdle here or the main obstacle to.
Get to this point is to open dissenters day, the things that takes the longest is to have all the centers in place to send.
Terrorism.
Up and running we see that we're recruiting quite nicely.
And this is something that is working very nicely with centers that are open. So we do expect Q2. The next time, which we will report from a recruitment you'll be able to judge what's the pace of recruitment now this centre zone.
Quoting are open.
Open and recruiting.
Excellent. Thank you very much for taking the questions.
Thanks, Jason.
Thank you so much there are no further questions at the moment. So please go ahead for the closing comments.
Yeah.
Okay.
Thank you.
Thank you for joining our fourth quarter and full year 2020.
So schools.
I'd like to say how excited we are of other focus we have achieved to date as well as a day comparing opportunities that lay ahead of us.
We remain grateful to our team members Hello.
Yes.
For this strong commitment to our mission and their collaboration to ensure we continue to advance us towards achieving our goals of bringing deeply ex 100.
Go ahead.
It is.
And patients as quickly as possible.
Oh.
Thank you so much that does conclude our conference for today. Thank you for participating you may all disconnect.
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