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spk10: 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 Chachkis-Oxobrod, Executive Vice President and Chief Financial Officer of PolyPID. Earlier today, PolyPID released financial results for the three months and nine months ended September 30th, 2021. A copy of the press release is available in the investor's section of the company's website, www.polyped.com. I'd like to remind you on this call, management will make forward-looking statements within the meaning of the federal securities laws. For example, 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, potential benefits of D-Plex 100 and Oncoplex, the company's potential partners, and the 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 Form 20F, which identifies specific factors which may cause actual results or events to differ materially from those described in the four legal statements. PolyP disclaims any intention or obligation, except those 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 10th, 2021. With the completion of those prepared remarks, It's my pleasure to turn the call over to Amir Weisberg, CEO. Amir?
spk05: Thank you, Bob. On behalf of our team at PolyPID, I would like to welcome everyone to our third quarter 2021 earnings call. I will begin today with some brief introductory comments. Dikla will provide a detailed 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 three program for our lead asset, DPLEX-100, 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 stay and readmission and adding up to $10 billion in annual medical costs. From a commercial perspective, as we discussed on our last call, we have developed a launch plan that including all the details activities that will occur from now until launch for the various functions at PolyPID, including sales and marketing, formulary access, and medical affairs. 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 polypids regarding this pre-launch activities in the US market. I'm also pleased to report that our promising Oncoplex development platform initially targeting brain tumor continues to generate compiling preclinical data which DECLA will highlight shortly. Of significance, our pre-IND meeting with the FDA, where we hope to achieve agreement with the agency on the preclinical and clinical development plan for Oncoplex, is scheduled 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 strength. We expect that our current balance sheet will be sufficient to complete the SHIELD 1 study, to conduct SHIELD 2, and prepare for the submission of NDA to the FDA, as well as further advance our on-complex development platform. With that, I will now turn the call over to Dikla to provide you with some further updates on our business. Dikla.
spk08: 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 SHIELD1 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 enrolled into the study, and based on the current environment, we anticipate that the recruitment rate will increase to 200 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 DPLEX-100. The FDA agreed that our proposal for single phase three pivotal study, provided the study results are adequate, would constitute significant evidence of clinical efficacy to support approval of DPLEX-100 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 US, EU, and Israel. Based on this agreement with the FDA, we have determined that it is in the best interest of our DPLEX-100 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-1 is well-powered and will provide additional data that will potentially be used to further demonstrate the medical and health economic benefits of DPLEX-100. 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 endpoint follow-up. We intend to further update investors and analysts on enrollment status once the 500 patients have been enrolled and then again following the blinded infection rate assessment. Based on the target enrollment of approximately 900 patients, we now anticipate the last patient to enroll in Shield 1 will be during the second quarter of 2022 and the availability of top-line data two months thereafter. Importantly, we believe the potentially significant commercial and pharmacoeconomic benefits of conducting SHIELD1 in the higher hand of the targeted patient enrollment range far outweigh the resulting modestly extended timeline to top-line data. From a financial standpoint, because we only need to conduct SHIELD1 to potentially receive FDA approval and do not need to ramp enrollment in SHIELD2 at an equally robust pace, we now anticipate that our cash runway will be extended to year-end 2022. This is an improvement from our prior expectations that our cash would fund us into the second half of 2022. As a reminder, approximately 70% of the patients currently enrolled in Shield 1 have a colorectal cancer diagnosis, a rate similar to the 74% seen in our successfully completed Phase II trial. The remaining procedures primarily consist of those related to Crohn's disease and IBD. Finally, the Data Safety Monitoring Committee, in charge with the review of accumulating safety data and study conduct for the SHIELD-1 study, has now recommended for the third time to continue the study without modification. meaning that no major safety issues related to DIPLEX-100 have been observed in SHIELD-1 to date. Moving on to SHIELD-2, our second Phase III trial in abdominal surgery, which includes broader relatability criteria, including minimally invasive procedures. This study also continues to progress as planned, although our focus remains on opening centers at the measured pace. total enrolled patient in SHIELD2 is currently over 130. In terms of potential collaboration for the future commercialization of DIPLEX100 in the US, we remain in dialogue with several large and mid-sized pharmaceutical and medical device companies that we believe would be ideal commercial partners for DIPLEX100. As I said on our last call, These companies are leaders in commercializing pharmaceutical products and medical devices, have strong established commercial infrastructures, exhibit a detailed understanding of clinical and pharmacoeconomic benefits in the hospital channel, and maintain strong relationships with the hospital clinical, medical, and administrative staff. Importantly, There continues to be a high level of interest in DIPLEX-100 from these potential partners. In parallel, we also remain in highly active discussions with multiple large and mid-sized strategic partners, all with significant presence and experience sailing into the hospitals and operating rooms for potential collaboration in Europe and Asia. Now I'd like to further elaborate on the status of Oncoplex. our intratumoral chemotherapy product candidate, initially targeting solid brain tumors, including those that are chemotherapeutic resistant. As a reminder, OncoPlex provides local, prolonged, and controlled exposure to Dosat XL in the intraoperative tumor resection setting. As you know, Dosat XL is one of the most widely used chemotherapy agent worldwide. Brain tumors were selected as the initial indication for Oncoplex because there is currently almost no meaningful chemotherapeutic treatment options for brain tumors, primarily due to the limited ability of the treatments to penetrate the blood-brain barrier. Due to the localized and prolonged nature of Oncoplex, we believe it is highly beneficial as compared to systemic treatments as well as the currently available local treatment in these devastating tumors that often cannot be fully resected surgically. We recently reported additional positive preclinical data in two key glioblastoma multiforme or GBM animal models, demonstrating that a single local treatment of Oncoplex significantly inhibited tumor growth and prolonged survival. In addition, a dose response was demonstrated for Oncoplex in the different animal models. These important results further support our work toward the pre-IND meetings with the FDA to potentially initiate a Phase I-II clinical trial. As Amir noted, we are pleased that we have a pre-IND meeting scheduled with the FDA for later this month with the objective of coming to agreement on a clinical and non-clinical development plan for Oncoplex in GBM. We remain focused on potentially initiating a Phase I-II clinical trial of Oncoplex in GBM in 2022 and continue to expand our network of top experts and KOLs around our Oncoplex development program to support our efforts in this promising area. With that, I will now review our recent financial results. Let's begin with Polypid's balance sheet information. As of September 30, 2021, the company had cash, cash equivalents, short-term and long-term deposits of $42 million, as compared to $67 million as of December 31, 2020. Cash used in operations for the three months ended September 30, 2021 total $10 million. Now let's turn to our income statement. Research and development expenses for the three months ended September 30, 2021 were $7.3 million compared to $4.2 million in the same three months period of 2020. The increase in research and development expenses resulted from the increased cost and activities related to the ongoing SHIELD I and SHIELD II Phase III clinical trials and abdominal surgery. Marketing and business development expenses for the three months of 2021 were $400,000 compared to $300,000 for the same period of 2020. General and administrative expenses for the third quarter of 2021 were $2.1 million, consistent with $2.2 million in the prior year period. For the third quarter of 2021, the company had a net loss attributable to ordinary shares of $9.9 million as compared to $6.5 million in the prior year period. We will now open the call to your question. Operator?
spk03: Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster. Your first question comes from the line of Gary Nachman from BMO Capital Markets. Please ask your question.
spk09: 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 1, 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 time frame is? And then I have a couple more.
spk08: So first, good morning and thank you for that. Maybe to better explain our decision regarding the 900 patients, we should remember that when we designed the trial, and when we started, we were under the understanding with the FDA that we need two phase three trials in order to get an NDA. And during this process, we received a 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 the second one will probably be modified to a smaller number. There's no need to do two 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. 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 earlier in the formal part, we do intend to invest. We do not expect it to change. 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 results, 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 two 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 patient in.
spk09: Okay. That's helpful. And then maybe just a little bit more on the type of partnership discussions that you're having. It sounds like it's across all regions, but that you're still planning on commercializing on your own in the U.S., you know, 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 more likely be outside the U.S.
spk08: So the partnership, I'll separate for a second. Just to remind everyone, our plan in the U.S. is to have 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 on our own. 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.
spk09: Okay. But even though licensing outside the US will likely come after the data, it seems.
spk08: It's hard to say. It's hard for us to say. It depends. 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.
spk09: Okay. All right, great. And then just lastly on Oncoplex, do you have a sense of what the Phase I-II 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, you know, is that something you could talk about at this point, maybe even just size or, you know, any other parts of the protocol? Thanks.
spk08: 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 detail on that. But let's give the FDA the Honored to be the first to react to that and give us the comment.
spk09: Okay, I won't be insulted. All right, guys, thank you very much.
spk08: Thank you. This is appreciated. Thank you, Gary.
spk03: Your next question comes from the line of Brandon Foulkes from Cantor Fitzgerald. Please ask your question.
spk02: Hi, thanks for the 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 SHIELD1. And I did hear your commentary, Dick, on reducing the overall number of patients potentially in SHIELD2, but should we think about SHIELD2 timelines maybe being pushed out somewhat and then maybe just any color in terms of How are you thinking of the bridge from colorectal to a broader label? That would just be helpful. Thank you.
spk08: First of all, thank you, Brendan, for this question because we do want to give some clarity on that. We are evaluating how best to pursue SHIELD2, and obviously with SHIELD2, the FDA recognizing that one pivotal trial is sufficient, we do not need to have SHIELD2 in such a robust size. SHIELD2 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 SHIELD1. This is not something that we will do now, But we do understand that with this development plan that is now in place, we do not need to have Shield 2 at such a large size. So obviously, we will need to invest less in Shield 2 in order to bridge this border-relatability criteria.
spk06: Beautiful. Okay.
spk02: That's not me, just to confirm. That's fine. You know, that's coffee time.
spk06: That's perfectly acceptable.
spk05: We know that it's really authentic.
spk02: Maybe could I just ask a follow-up here? I understand you're probably not going to comment. it but we have seen another company within a different division in the FDA come out recently and you know they got a narrower label on approval and it's you know it's in the hospital it's in the post-surgical environment the product they came back after the commentary that the FDA has just asked them to collect additional data on some you know get a wider variety of procedures but I really not asking for efficacy data in those procedures and really just looking at PKPD. Is that anything you're willing to comment on at the moment?
spk08: So I can't really comment because this is something, you know, 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 both the mechanism of action of DPLEX-100 as well as the area that we are with DPLEX-100, an anti-infective product, and the breakthrough therapy, all these parameters together we think are in our favor. But this will need to be discussed with the FDA when we have the the end of phase three meeting.
spk02: Great. Thank you very much. I appreciate all the color and congrats on the progress.
spk08: Thank you.
spk03: Your next question comes from the line of Balaji Prasad from Barclays. Please ask your question.
spk01: Hello, Erin. So again, as Erin mentioned, it's great to see the progress and you're getting there. Couple of questions, one on the expense side. Can you understand what is the spread of expenses between Shield 1 and Shield 2? 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, be it on the commercial side or the clinical positioning, and anything else? Thanks.
spk08: So before I relate to the second part, could you repeat the first part of your question?
spk01: Yeah, absolutely. What I mentioned was it's great to see that there are no safety signals in Shield 1, and what's the split of expenses between Shield 1 and Shield 2 currently?
spk08: 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 to $25 million, the cost of each Phase III. 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 as a pivotal, but more as a Phase IV trial. It could be reduced in terms of the number of patients 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 geography, 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 health care in different countries, and this is very encouraging in our eyes.
spk01: Thank you.
spk03: Your next question comes from the line of Roy Buchanan from JMP Securities. Please ask your question.
spk12: Great. Thanks for taking the questions. I guess the first one on Shield 2, maybe this is a moot point because it sounds like you're I'm going to resize the trial, but just curious if you're also seeing the enrollment rates increase in Shield 2 as you're seeing in Shield 1.
spk08: First of all, our basic assumption was that recruitment in Shield 2 will be faster because 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 1, where we have approximately 60 centers that are opened, this is not the case yet in Shield 2. And now that we are fully focused on Shield 1 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 2 at the optimum size that is required for just broadening the indication and having it as a Phase 4 as opposed to Shield 1, which is a Phase 3 trial.
spk12: Okay. Great. I want to dig in a little bit on something you said about Shield 1. 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. 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? And what's the plan at 500 patients? They're going to potentially stop the trial at that point. Thanks.
spk08: So first, I want to make clear that 500 patients is not an interim analysis. So everyone is blinded to it. It's not something that we don't open the data at this stage. It's an overlook to the data without blinding it, so 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 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 we are hoping for. With regards to the DSMB, this is very standard. DSMB's charters 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. In our case, this was a minimum of 600 patients, 616 if you want to be 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.
spk12: Got it. Okay. Great. That's helpful. Thanks. 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.
spk08: 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 at the price that 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.
spk12: Okay. Thanks for taking the questions.
spk08: Thank you.
spk03: Your next question comes from the line of Jim Malloy from AGP. Please ask your question.
spk11: Hey, guys. Good evening. Thank you for taking my questions. I had a quick question on the S2. I know we've just been touched upon, and obviously it's less urgency now. What is the ultimate goal on the Shield 2? on running that now that it's not a priority, mission critical for NDA filing? That sort of run of the safety, what's the thinking on sort of running out the SHIELD2 trial at this point?
spk08: So the SHIELD2 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 minimally invasive Shield 1 is now focused on open procedure, is mainly focused on open procedure, and Shield 2 will give us the ability to broaden the indication to minimally invasive, and we are looking also if we will need to have some small portion of additional abdominal surgeries. With our different dialogues with the agency, the European and the FDA, this is not necessarily the case because colorectal resection is viewed as sort 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.
spk11: And what's the thinking on SHIELD3, the expansion of the bone tissue, the sternum surgeries? Where does it sort of stand and what do you anticipate seeing there now getting the emphasis on SHIELD1?
spk08: As we said, this will be something that we will only start and initiate after we have the top-line results from SHIELD1 and have our discussions with the FDA on the end of phase three meeting and on the labeling.
spk11: And then the last question on Oncoplex. Any thoughts on dose attacks or the migration from sort of the application site? Obviously one of the things you'll be looking at. Any thoughts on what you anticipate there?
spk06: Can you repeat the question, Tim?
spk11: Sure. Looking at the Oncoplex trial, the local application of docetaxel, any thoughts on, you know, confidence on keeping the docetaxel from migrating from sort of the local application side? Obviously, the whole idea being you use it locally rather than systemically.
spk08: Sure. So, 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 chemotherapeutic agent in the GBM 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 tumor residual site, combined with the prolonged exposure that can potentially cover or the area of the residual tumor site.
spk11: Thank you for taking the questions.
spk03: You're welcome. Once again, if you wish to ask a question, please press star 1 on your telephone. Your next question comes from the line of Ram Zalvaraju from HC Wainwright. Please ask your question.
spk07: Hi, this is Bhoobalan dialing in for Ram Zalvaraju, and thanks for taking my question. So firstly, have you done any physician-based market research and payer research concerning D-Plex 100 commercialization? If so, can you share some key takeaways?
spk08: Sure. So we have done a very robust study, some of which we've already – we actually have done two, but one more recently interviewing 80 stakeholders – about half of it being surgeons, abdominal surgeons, cardiovascular surgeons, and orthopedic surgeons, and the other half being hospital administrators, pharmacists, PT committees. And I think there are many takes out of it, but the two that is, from our perspective, maybe worth mentioning, and we can elaborate in future calls more about that, is first the 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 survey, 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 surgeons, the doctors, and the hospital administrators. The surgeons and the doctors are tending to be more prone to adopting new technologies and new devices versus the pharmacies that the PT committees are pushing back and saying, we don't have the budget for that. This wasn't the case. 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.
spk07: 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 primates? Also, can you comment on the safety and stability profile of OncoFlex?
spk08: So I'll start with the second part, and maybe I'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 dose of DOS of Excel when you are administrating it locally is very, very minimal. You could even, it's almost 1% of what would be administrated systemically. That's how small the overall dose, because it's where it's needed as a target and 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 were asking about our pre-IND meeting this month?
spk07: Yes, the pre-IND meeting.
spk08: So what you want to ask about it?
spk07: So the question is, obviously you've demonstrated efficacy rat models and mouse models. So I'm just curious whether the FDA might want to know the efficacy of the drug in non-human primates, meaning large animal models, because of the nexus between the non-human primates and the predicting therapeutic response.
spk08: 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.
spk07: Understood. So, along the lines, several experts argue that temozolomide is a paradigm shifting drug in glioblastoma treatment. In fact, a study has 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?
spk08: So there are many drugs that can be used as an agent for OncoPlex. And we don't have to stop at chemotherapy. The Plex 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. 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 Dosset-Excel first, because 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 until now in preclinical, and we are confident that we will continue to see them in clinical studies as well.
spk03: Thank you. Your next question comes from the line of Elliott Wilbur from Raymond James. Please ask your question. Hello, DECA.
spk04: This is Hannah Smith on behalf of Elliott. Regarding DEPLEX, any changes to secondary endpoints in either of the trials around marketing-related data points based on feedback from payers and providers?
spk08: No changes at all. We are continuing as planned And we haven't changed any of the secondary endpoint or the primary endpoint.
spk04: Okay, great. Thank you.
spk08: Thank you very much.
spk03: Thank you. There are no further questions, so I would like to hand back to Amir Weisberg for any closing remarks.
spk05: 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 DPLEX-100 clinical program as well as the opportunities that Lea had for us. 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-Plex 100 and OncoPlex to healthcare
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