Thank you all for participating in PolyPid’s Third Quarter 2021 Earnings Conference Call. Joining me on the call today will be Amir Weisberg, Chief Executive Officer; and Dikla Czaczkes Akselbrad, Executive Vice President and Chief Financial Officer of PolyPid. Earlier today, PolyPid released financial results for the three months and nine months ended September 30, 2021. A copy of the press release is available in the Investors section of the company’s website, www polypid.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 it discusses the expected recruitment for trials, timing of trials and results thereof, the capacity of the company’s manufacturing facility, the company’s pipeline, the potential benefits of D-PLEX100 and OncoPLEX, the company’s potential partners and sufficiency of the company’s cash to fund future operations. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings. 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. 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 company’s Forms 20-F, which identifies specific factors, which may cause actual results or events to differ materially from those described in the forward-looking statements. PolyPid 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 today, November 10, 2021. And with the completion of those prepared remarks, it’s my pleasure to turn the call over to Amir Weisberg, CEO. Amir?

Thank you, Bob. On behalf of our team at PolyPid, I would like to welcome everyone to our first quarter 2021 earnings call. I will begin today with some brief introductory comments, Dikla will provide the detail business update and then she will review our financial results after which we will open the call for your questions. We continue to rapidly advance our many development programs, as well as our commercial preparations most importantly, our large Phase 3 program for our lead asset D-PLEX100 for the prevention of surgical site infections, or SSI is progressing as planned. As a reminder SSI account for around 20% of all hospital acquired infections in the U.S. resulting in extended hospital state and readmission, and adding up to $10 billion in annual medical costs. From a commercial perspective, as we discuss on our last call, we have developed a launch plan that including all the detailed activities that will occur from now until launch for the various functions at PolyPid, including sales and marketing, formulary access and medical affair. In addition, a resource plan has been developed to determine hiring needs and timing for each of the different functions, as well as the infrastructure that will be needed in preparation for launch. In addition, we have also engaged a leading launch excellent service provider to support PolyPid regarding this relaunch activities in the U.S. market. I am also pleased to report that our promising OncoPLEX development platform initially targeting brain tumor continues to generate compelling preclinical data, which Dikla will highlight shortly. Of significant our pre-IND meeting with the FDA where we hope to achieve agreements with the agency on the pre-clinical and clinical development plan for OncoPLEX is schedule to take place later this month. Based on our recent accomplishment, PolyPid is well positioned for further clinical and operational success. Moreover, we continue to operate from a position of financial strengths. We expect that our current balance sheet will be sufficient to complete the SHIELD I study to conduct SHIELD II and prepare for the submission of NDA to the FDA as well as further advance our OncoPLEX development platform. With that, I will now turn the call over to Dikla to provide you with some further updates on our business. Dikla?

Thank you, Amir, and thank you all for joining us on the call. I would like to begin with a brief discussion on the status of our pipeline. The pace of enrollment in the SHIELD I trial has continued to increase over the last several months and we expect an even greater acceleration in enrollment in the coming months. We now have approximately 480 patients enroll into the study and based on the current environment, we anticipate that the recruitment rate will increase to 200 patients to 250 patients per quarter. As you know, during the second quarter of 2021, we received written responses from the FDA regarding our development plan for D-PLEX100. The FDA agreed that our proposal for single Phase 3 pivotal study provided the study result are adequate, would constitute significant evidence of clinical efficacy to support approval of D-PLEX100 for the prevention of SSI in colorectal surgery. As a reminder, our plan was to enroll up to 900 patients into the study within 60 centers in the U.S., EU and Israel. Based on disagreement with the FDA, we have determined that it is in the best interest of our D-PLEX100 program to utilize the higher end of the targeted patient enrollment range for this study, which is approximately 900 patients. From a clinical perspective, this will help ensure that SHIELD I is well powered and will provide additional data that will potentially be used to further demonstrate the medical and health economic benefits of D-PLEX100. As we reached approximately 480 patients, we expect to enroll 500 patients by the end of the month and to blindly assess the overall infection rate in the trial once these 500 patients have completed the one month primary end point follow-up. We intend to further update investors and analyst on…

Thank you. [Operator Instructions] Your first question comes from the line of Gary Mattan from BMO Capital Markets. Please ask your question.

Hi guys, good morning, and nice to see all the progress. First with the decision to go to the higher end of the target enrollment range for SHIELD I, you haven’t done the sample size re-estimation yet. So could the target number change depending on that re-estimation and the results that you get from that? And then the pace that you need you said Dikla to get to 900 from the 480 currently in the second quarter, are you factoring any potential headwinds from COVID? If there’s a resurgence, how locked in do you think that timeframe is? And then I have a couple more.

So, first good morning, and thank you for that. Maybe to better explain our decisions regarding the 900 patient. We should remember that when we designed the trial and when we started, we were under the ending with the FDA that we need two Phase 3 trial in order to get an NDA. And during this process, we received the breakthrough therapy, which essentially said, we only, we got an agreement with the FDA, that one trial is sufficient. And with that, as we started to progress, we understand that we are going to go to the approval and the marketing stage with only one trial. And second one will probably be modified to a smaller number. There’s no need to do to fully pivotal studies if you’re not requested to. And we wanted to make sure that we have, in addition, of course, to the efficacy primary endpoint, we have sufficient health economic data and marketing data. And this was the decision. The 500 is just weeks or even days in terms of reaching the last patient to 500 as we are now in approximately 480. And as we said to earlier in the formal part, we do intend to invest. We do not expect it to change. This is our expectation is that this will be the number. The DSMB always have as part of their charter and ability to stop us earlier due to overwhelming result. But it’s still too early to look at that. With regards to the pace of enrollment. If you look more in an overview look, you can see that during the second quarter, we recruited 100 patients during the third quarter, we recruited 180 and now we are comfortable saying that we expect that this will be getting to the top of our expectation, which is a 200 to 250 patients per quarter. So starting from a point of 480 patients that we have now, you can very easily see how we get to the second quarter with the last, with the last patient in.

Okay. That’s helpful. And then maybe just a little bit more on the, the type of partnership discussions that you’re having. It’s a sounds like it’s across all regions, but that you’re still planning on commercializing on your own in the U.S. and that you hired someone to potentially help you plan that. So, I guess I’m just a little confused if you think you will end up commercializing in the U.S., or if you’ll find a partner or if that partnership will likely more likely be outside the U.S.

So the partnership I’ll separate for a second, just to remind everyone, our plan in the U.S. is to have what somewhat of a strategic collaboration. So on one hand, we do want to have our boots on the ground and have some level of presence. This is the main market. We do want to have some presence and putting the plan in place doesn’t mean that everything in this plan will be executed by our – on our own. It could be – so some part of it will be executed by us. And some of it, when we do sign, a partnership will be executed with a partner. The idea is to have a strategic partner. Our thinking is that, this will probably be signed after, we have the data in the U.S. with regards to Europe, we are in discussion more than evaluating the partners and keeping them updated to where we are. And this could fairly, since in Europe and Asia and the rest of the world, we do look for licensing agreements. Those are things that are in discussion. And of course, it’s not something we can put timeline on it.

Okay. But even though licensing outside, the U.S. will likely come after the data it seems.

It’s hard to say, it’s hard for us to say it. It depends. There is a point in the discussions where data is just around the corner, then this will be the case, but it’s hard for us to say at this stage.

Okay. All right. Great. And then just lastly, on OncoPLEX, do you have a sense of what the Phase 1/2 study in GBM might look like? I know you’re going to have the pre-IND meeting with FDA, but going in, I’m assuming you have an idea. So, is that something you could talk about at this point, maybe even just size or any other parts of the protocol? Thanks.

So, we do have a sense because the meeting with the FDA, as we said is this month, and we’ve already submitted the package. I think it’s best to get the feedback and see if everything that we’ve suggested in terms of the preclinical and clinical development plan is in line with what the agency is. And then we can give more, more detail on that, but let’s give the FDA the honor to be first to react to that and give us the comment.

Okay. I won’t be insulted [ph]. All right, guys. Thank you very much.

Thank you. Thank you, Gary.

Your next question comes from the line of Brandon Folkes from Cantor Fitzgerald. Please ask your question.

Hi, thanks for my questions and congratulations on all the progress. I just wanted to drill down a little bit more on the cash runway, and understanding how we’re going to go to the high end of the range in patients in SHIELD I should – and I did hear your commentary Dikla on reducing the overall number of patients potentially in SHIELD II, but should we think about SHIELD II timelines, maybe being pushed out somewhat. And then, maybe just any color in terms of how you’re thinking of the bridge from colorectal to a broader label. Yes, that’d just be helpful. Thank you.

So you are – first of all, thank you Brandon for this question, because we do want to give some clarity on that. We are evaluating how best to pursue SHIELD II. And obviously with the FDA, recognizing that one pivotal trial is sufficient, we do not need to have SHIELD II in such a robust size. SHIELD II does have a broader eligibility criteria, that can help us broadening the indication. And this is something that will be updated as we go and get closer to top-line results with SHIELD I. This is not something that we will do now, but we do understand that with this development plan – we do not need to have SHIELD II at such a large size. So, obviously we will need to invest plants in SHIELD II in order to bridge these broader eligibility criteria.

That’s not me. Just to confirm.

That’s fine. That’s – COVID time. That’s perfectly acceptable.

Yes, and I have…

We know it’s really authentic.

And maybe could I just ask a follow up here, and feel I understand you’re probably not going to comment on it, but we have seen another company within a different division in the FDA come out recently, and they got a narrower label on approval and it’s in the hospital, it’s in the post surgical environment, the product. They came be answer the commentary that the FDA has just asked them to collect additional data on some – I guess the wider variety of procedures, but really not asking for efficacy data in those procedures. And really just looking at PK/PD. Is that anything you’re willing to comment on at the moment?

So, I can’t really comment because this is something, we’ll need to discuss with the FDA, but we are looking at it. And this is from our perspective and also looking at other product in the surgery suite. This is very in line of what we see. And we think that in the, both the mechanism of action of D-PLEX100, as well as the area that we are with D-PLEX100 an anti-infective products and the breakthrough therapy, all these parameters together we think our – in our favor, but this will need to be discussed with the FDA when we have the end of Phase 3 meeting.

Great. Thank you very much. I appreciate all the color and congrats on the progress.

Thank you, Brandon.

Your next question comes from the line of Balaji Prasad from Barclays. Please ask your question.

Hello everyone. So again, I mentioned, it’s great to see the progress and you’re getting there couple of questions on one on the expense side. Can you help us understand what is the spread of expenses between SHIELD I and SHIELD II? And secondly, with regard to your partnership discussions, and as it evolves with the progress in enrollment, are there any new learnings that you are getting from your partnership discussions made on the commercial side or the clinical positioning, and anything else? Thanks.

So, before I relate to the second part, could you repeat your – the first part of your question?

Yes, absolutely. What I mentioned was it’s great to see that there are no safety singles in SHIELD I and what’s the split of expenses between SHIELD I and SHIELD II currently?

Sure. So, in general, I can tell you that they were supposed to cost more or less the same in terms of we were talking about $20 million to $25 million, the cost of each Phase 3. So, you could speculate from that, what could be the savings? We are not stopping SHIELD II, of course, and we do want to pursue it, but we will be modifying it now that we don’t need it in – as a pivotal, but more as a same four trials, it could be reduced in terms of the number of patient that are required. With regard to the second question about feedback. I can tell just a bit of color of what we see. First, we are very pleased with the level of interest, and we see that the interest is not limited to specific choreography, but it’s worldwide. And we are also very happy to get some insight on the unmet need in these different geographies. And this is something that, from our perspective is encouraging. We see both the interest and the unmet need and the cost of it today to the different hospitals and the different healthcare in different countries and this is very encouraging in our eyes.

Okay, thank you.

Your next question comes from the line of Roy Buchanan from JMP Securities. Please ask your question.

All right. Great. Thanks for taking the questions. I guess the first one on SHIELD II, maybe this is a move point, because it sounds like you’re going to resize the trial, but just curious if you’re also seeing the enrollment rates increase in SHIELD II, as you’re seeing in SHIELD I?

So we, first of all, our basic assumption was that recruitment in SHIELD II will be faster because it’s – it has a broader eligibility criteria. And in the few centers that were opened since we started this trial, we see that. We see that it’s potentially a trial that will be easier to recruit, because of the broader eligibility criteria. But as we said in our formal part, we are still at the stage of opening the center. So as opposed to SHIELD I where we have approximately 60 centers that are opened this is not the case yet in SHIELD II. And now that we are fully focused on SHIELD I, and this is our pivotal trial for approval. We can balance that in terms of expenses and runway and make sure that we are having SHIELD II and at the optimum side that is required for just broadening the indication and having it as a Phase 4, as opposed to SHIELD I, which is a Phase 3 trial.

Okay, great. And then I want to dig in a little bit on something you said about SHIELD I. So, you’re still conducting this interim analysis on infection rates at 500 patients. And I don’t think you plan to announce the infection rate, but can you just confirm that, and then the comment you made about the DSMB looking at the potential overwhelming efficacy, but it’s too early. Is that – does that mean that they haven’t looked for efficacy? Just because you don’t have enough patients or they’ve looked and you don’t expect to see anything because there aren’t enough patients or what’s the plan at 500 patients they’re going to potentially stop the trial at that point. Thanks.

So first I want to make clear the 500 patient is not – it’s not an interim analysis. So everyone is blinded to it is it’s not something that we don’t open the data at this stage. It’s an over look into the data without blinding it. So we – it’s not a real understanding of the efficacy, and yes, we will not be able to share the infection rate since, as we said, it’s blinded, but we – this could give us a reassurance into the fact that we are on track and that the number of patients could get us to the point that, that we are hoping for. With regards to the DSMB. This is very standard. DSMB is charter do have the ability to stop a trial based on overwhelming results. This is not something that is unique to ours, but you still need to have the level of safety that is required before they can even look at it. Then in an hour case, this was a minimum of 600 patients, 616, if you want to be precise. So, when I was saying, this is too early, that means that we are not aware if they looked at it or not. Of course, it’s not something that there is no dialogue between us and the DSMB, but once we – this is part of their charter to look at it, but first you need to have the minimum patient in terms of safety.

Got it. Okay, great. That’s helpful. Thanks. And then on the cash runway, excuse me, has the ATM contributed to that at all? It doesn’t look like you used it in 3Q, just looking at the share count reported, but have you used it since the end of the quarter? Thanks.

So this is not something that we are going to update except for, of course, the financial and as you mentioned, it’s obvious that we haven’t used it. We did say that we are not going to use it, that the price we saw in the quarter, and we see no need for that, especially now with the sharing, with investors that we have extended our cash runway into the end of next year. There’s no need to use this tool in this level of share price.

Okay. Thanks for taking the questions.

Thank you

Your next question comes from the line of Jim Molloy from A.G.P. Please ask your question.

Hey guys. Good evening. Thank you for taking my questions. I had a quick question on the S II. I know we’ve just been touched upon, and obviously it’s a less urgency now. What is the ultimate goal on the SHIELD II, I should say, not S II, SHIELD II on running that now that it’s not a priority mission critical for NDA filing that’s sort of run as a safety. What’s the thinking on sort of running out the SHIELD II trial at this point?

So the SHIELD II is, has two objectives. One of course, is safety. And the second one is to have a broader eligibility criteria to broader the indication mainly to minimal invasive. SHIELD I is now focused on open procedure is mainly focused on open procedure and SHIELD II will give us the ability to broadening the indication to minimal invasive. And we are looking also if we will need it to have some small portion of additional abdominal surgeries. With our different dialogues with the agents in the European and the FDA this is not necessarily the case, because correct cell resection is viewed as the thought of the worst case in abdominal surgery, in terms of the level of infection there, we are looking at double-digit infection rate in U.S. in open abdominal procedures. So this is the worst case of abdominal surgery in terms of surgical site infection.

And what’s the thinking on SHIELD III the expansion to bone tissue, the sternum surgeries what does it sort of stand? And what’s – what you’re expect to seeing there now and get answers on SHIELD I?

As we said, this will be something that we will only start and initiate after we have the top-line result from SHIELD I and have our discussions with the FDA on the end of Phase 3 meeting and on the labeling.

And then any last question on OncoPLEX, any thoughts on docetaxel, the migration from sort of the application site? Obviously one of the things you’d be looking at any thoughts on we anticipate there?

Can you repeat the question, Jim?

Sure. Looking at the, the OncoPLEX trial, the local application of docitaxel any thoughts on confidence on keeping the docetaxel from migrating from sort of the local applications that obviously the whole idea being, used it locally rather than systemically.

Sure. Thank you for that. That’s from our perspective, this is what we believe is the added value of our PLEX platform. The ability to the combination of two abilities, the ability to be anchored locally, to be locally and stay locally, as well as having prolonged local delivery, we think, and also looking at some other local chemotherapy agent in the GPM arena, we believe that this is why OncoPLEX could bring substantial added value because of its ability, because of the size of the drug that it’s 100 micron, and it’s not migrating from the site of application, the human residual site, combined with the prolonged exposure that can potentially cover all the area of the residual tumor side.

Thank you for taking the questions.

Welcome.

[Operator Instructions] Your next question comes from the line of Ram Selvaraju from H.C. Wainwright. Please ask your question.

Hi, this is Boobalan dialing in for Ram Selvaraju. And thanks for taking my question. So firstly, have you done any physician based market research and payer research concerning D-PLEX100 commercialization? If so, can I share some key takeaways?

Sure. So, we have done a very robust study. Some of it we’ve already – we have actually done two, but one more recently interviewing 80 stakeholders about half of it being surgeon, abdominal surgeon, cardiovascular surgeon, an orthopedic surgeon, and the other half being hospital administrators, pharmacists, PT committees. And I think there are many take out of it, but the two that is from our perspective, maybe worth mentioning, and we can elaborate in future call more about that, is first the level of interest, level of interest, the level of understanding and the level of day to day dealing with the cost of surgical site infection. This was clear from this survey with this anonymous surveys in depth interviews. And the other one that we think is very important is worth mentioning. You usually see in those new product favor for adoption, some level of tension between the surgeon, the doctors, and the hospital administrators, the surgeon, and the doctors are tending to be more prone to adopt new technologies and new devices versus the pharmacies, the PT committees are pushing back and saying, we don’t have the budget for that. This wasn’t the case in our D-PLEX100, in this survey, we actually saw equal interest. And in some cases, even higher interest, let’s say in abdominal surgery of the people that are responsible for the budgeting, and this is a very important take out for us.

Okay. Thanks for the clarity there. So obviously your pre-IND meeting is coming up. So, do you think the FDA might want to see the efficacy of your drug in non-human premises? Also can you comment on the safety and stability profile of OncoPLEX?

So I I’ll start with the second part, and maybe you’ll clarify a bit what you are referring to in the first part. In terms of safety, we now have quite robust preclinical package on safety. I think it’s worth mentioning that the overall docetaxel, when you are administrating it locally is very, very minimal. You could even, it’s almost 1% of what would be administrative systemically that’s how small the overall dose, because it’s where it’s needed at the target at the unmet need directly. And there is no use of the systemic administration that dilutes the drug. We can have it as an overall small dose. And you are asking about our pre-IND meeting this month?

Yes. The pre-IND meeting.

So, what do you want to ask about it?

So the question is obviously you demonstrated efficacy in rat models and mouse models. So, I’m just curious whether the FDA might be, they want to know the efficacy of your drug in nonhuman premise, meaning large animal models, because of the nexus between the nonhuman premise and the predicting therapeutic response.

So this is exactly the reason to conduct the pre-IND meeting and get the feedback on our suggested plan and everything that was already done. I mean, we already have a robust preclinical package that we’ve submitted asking if this is sufficient, we’ll need to wait and hear from the FDA before we can comment on that.

Understood. So along the lines, several experts argue that temozolomide is a paradigm shifting drug and glioblastoma treatment. In fact, a study shown that it increased the two-year survival from 8% in patients with radiotherapy alone to 20% in patients with combined therapy. So is there a reason not to include temozolomide in your OncoPLEX formulation?

So, there are many drug that can be used in as an agent for OncoPLEX and we don’t have to stop at chemotherapy, the plaque platform. And this was demonstrated in some past research collaboration that we had can also be utilizing antibodies and be specific. And really there are numerous opportunities here to start and touch the point in cancer. It’s definitely is not limited to chemotherapy and not to a specific chemotherapy. What we think and what we see today is that the limiting factor with GBM is the blood brain barrier. And bypassing this limiting factor can change the efficacy of many drugs. The reason for choosing docetaxel first, because this is it’s part of the labeling of the drug. So it’s easier in many aspects to come to the FDA with this, but there are other drugs that could also be efficacious. We are very pleased with the data that we see up and until now pre-clinical. And we are confident that we will continue to see them in clinical studies as well.

Thank you. Your next question comes from the line of Elliot Wilbur from Raymond James. Please ask your question.

Hello, Dikla. This is Hannah Smith on behalf of Elliot. On regarding D-PLEX, any changes to secondary endpoints in either of the trials around marketing related data points based on feedback from payers and providers?

No changes at all. We are continuing as planned and we haven’t changed any of the secondary endpoint or the primary endpoint.

Okay, great. Thank you.

Thank you very much.

Thank you. There are no further questions. So would like to hand back to Amir Weisberg for any closing remarks.

Thank you for joining our third quarter 2021 earnings conference call. I would like to say again, how excited we are about the progress we have achieved to date, especially in our D-PLEX100 clinical program, as well as the opportunities that layer in the fast. 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 toward achieving our goal of bringing D-PLEX100 and OncoPLEX to healthcare providers and patients as quickly as possible. Thank you.