Earnings Call Transcript
PolyPid Ltd. (PYPD)
Earnings Call Transcript - PYPD Q3 2021
Operator, Operator
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 that 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?
Amir Weisberg, CEO
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 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 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 accounts for around 20% of all hospital-acquired infections in the U.S., resulting in extended hospital stays and readmissions, 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 includes 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 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. We have also engaged a leading launch service provider to support PolyPid regarding these launch activities in the U.S. market. I am also pleased to report that our promising OncoPLEX development platform, initially targeting brain tumors, continues to generate compelling preclinical data, which Dikla will highlight shortly. Of significant note, our pre-IND meeting with the FDA, where we hope to achieve agreements with the agency on the preclinical and clinical development plan for OncoPLEX, is scheduled to take place later this month. Based on our recent accomplishments, 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 I study, to conduct SHIELD II, and prepare for the submission of an 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 Czaczkes Akselbrad, CFO
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 enrolled in 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 a single Phase 3 pivotal study, provided the study results are adequate, would constitute significant evidence of clinical efficacy to support the 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 the dialogue 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 could 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 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 I 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 SHIELD I in the higher end 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 SHIELD I to potentially receive FDA approval and do not need to ramp enrollment in SHIELD II 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 I have a colorectal cancer diagnosis, a rate similar to the 74% seen in our successfully completed Phase 2 trial. The remaining procedures primarily consist of those related to Crohn’s disease and IBD. Finally, the Data Safety Monitoring Committee in charge of the review of accumulating safety data and study conduct for the SHIELD I study has now recommended for the third time to continue the study without modification, meaning that no major safety issues related to D-PLEX100 have been observed in SHIELD I to date. Moving on to SHIELD II. Our second Phase 3 trial in abdominal surgery, which includes broader eligibility criteria, also continues to progress as planned, although our focus remains on opening centers at a measured pace. Total enrolled patients in SHIELD II is currently over 130. In terms of potential collaboration for the future commercialization of D-PLEX100 in the U.S., we remain in dialogue with several large and midsized pharmaceutical and medical device companies that we believe would be ideal commercial partners for D-PLEX100. 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 side. Importantly, there continues to be a high level of interest in D-PLEX100 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 selling 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 docetaxel in the intra-operative tumor resection setting. As you know, docetaxel is one of the most widely used chemotherapy agents worldwide. Brain tumors were selected as the initial indication for OncoPLEX because there are currently almost no meaningful chemotherapeutic treatment options for brain tumors, primarily due to the limited ability of treatments to penetrate the blood-brain barrier. Due to the localized and prolonged nature of OncoPLEX, we believe it is highly beneficial 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. Additionally, a positive response was demonstrated for OncoPLEX in different animal models. These important results further support our work toward the pre-IND meetings with the FDA to potentially initiate a Phase 1/2 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 an agreement on a clinical and non-clinical development plan for OncoPLEX in GBM. We remain focused on potentially initiating a Phase 1/2 clinical trial of OncoPLEX in GBM in 2022 and continue to extend 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, totaled $10 million. Now, let’s turn to our income statement, research and development expenses for the three months ended September 30, 2021, was $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 costs and activities related to the ongoing SHIELD I and SHIELD II Phase 3 clinical trials in 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 compared to $6.5 million in the prior year period. We will now open the call to your questions.
Operator, Operator
Thank you. Your first question comes from Gary Mattan from BMO Capital Markets. Please go ahead with your question.
Gary Mattan, Analyst
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.
Dikla Czaczkes Akselbrad, CFO
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 understanding with the FDA that we need two Phase 3 trials in order to get an NDA. During this process, we received the breakthrough therapy designation, which essentially said one trial is sufficient. As we started to progress, we understand that we are going to go to the approval and marketing stage with only one trial. The second one will probably be modified to a smaller number. There’s no need to conduct two fully pivotal studies if you’re not requested to. We wanted to make sure that we have, in addition to the primary endpoint efficacy, we have sufficient health economic data and marketing data. 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 at approximately 480. We do not expect it to change. This is our expectation that this will be the number. The DSMB always has as part of their charter the 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 at an overview, you can see that during the second quarter, we recruited 100 patients; during the third quarter, we recruited 180 and now we are confident in saying that we expect this to get to the top of our expectation, which is 200 to 250 patients per quarter. So starting from a point of 480 patients that we have now, you can easily see how we get to the second quarter with the last patient in.
Gary Mattan, Analyst
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. 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 be more outside the U.S.
Dikla Czaczkes Akselbrad, CFO
The partnerships I’ll separate for a second, just to remind everyone, our plan in the U.S. is to have somewhat of a strategic collaboration. On one hand, we 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 us. 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. Regarding Europe, we are in discussions to evaluate the partners and keeping them updated to where we are. This could happen fairly soon 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 a timeline on.
Gary Mattan, Analyst
Okay. But even though licensing outside the U.S. will likely come after the data, it seems.
Dikla Czaczkes Akselbrad, CFO
It’s hard to say. 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.
Gary Mattan, Analyst
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 the 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.
Dikla Czaczkes Akselbrad, CFO
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 expects. Then we can give more detail on that, but let’s give the FDA the honor of being first to react to that and give us their comments.
Gary Mattan, Analyst
Okay. I won’t be insulted. All right, guys. Thank you very much.
Dikla Czaczkes Akselbrad, CFO
Thank you. Thank you, Gary.
Operator, Operator
Your next question comes from the line of Brandon Folkes from Cantor Fitzgerald. Please ask your question.
Brandon Folkes, Analyst
Hi, thanks for taking 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. 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.
Dikla Czaczkes Akselbrad, CFO
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. 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 broader eligibility criteria that can help us broaden the indication. 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. Obviously, we will need to invest plans in SHIELD II in order to bridge these broader eligibility criteria.
Brandon Folkes, Analyst
That’s not me. Just to confirm.
Dikla Czaczkes Akselbrad, CFO
That’s fine. That’s perfectly acceptable.
Brandon Folkes, Analyst
Yes, and I have…
Amir Weisberg, CEO
We know it’s really authentic.
Brandon Folkes, Analyst
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 responded to 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?
Dikla Czaczkes Akselbrad, CFO
So, I can’t really comment because this is something we’ll need to discuss with the FDA, but we are looking at it. From our perspective, also looking at other products in the surgical suite, this is very in line with what we see. We think that in both the mechanism of action of D-PLEX100, as well as the area that we are with D-PLEX100, being an anti-infective product and its breakthrough therapy designation, all these parameters together work in our favor. But this will need to be discussed with the FDA when we have the end of Phase 3 meeting.
Brandon Folkes, Analyst
Great. Thank you very much. I appreciate all the color and congrats on the progress.
Dikla Czaczkes Akselbrad, CFO
Thank you, Brandon.
Operator, Operator
Your next question comes from the line of Balaji Prasad from Barclays. Please ask your question.
Balaji Prasad, Analyst
Hello everyone. It’s great to see the progress, and you’re getting there with a couple of questions. 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, 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.
Dikla Czaczkes Akselbrad, CFO
Before I relate to the second part, could you repeat your first part?
Balaji Prasad, Analyst
Yes, absolutely. What I mentioned was it’s great to see that there are no safety signals in SHIELD I, and what’s the split of expenses between SHIELD I and SHIELD II currently?
Dikla Czaczkes Akselbrad, CFO
Sure. 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. 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 trial, but more as a Phase 4. Trials could be reduced in terms of the number of patients that are required. Regarding the second question about feedback. I can provide a bit of color on 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. We are also very happy to get some insight into the unmet need in these different geographies. This is something that, from our perspective, is encouraging. We see both the interest and the unmet need and the costs of it today to the different hospitals and the different healthcare systems in different countries, and this is very encouraging in our eyes.
Balaji Prasad, Analyst
Okay, thank you.
Operator, Operator
Your next question comes from the line of Roy Buchanan from JMP Securities. Please ask your question.
Roy Buchanan, Analyst
All right. Great. Thanks for taking the questions. I guess the first one on SHIELD II. Maybe this is a moot 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?
Dikla Czaczkes Akselbrad, CFO
So, first of all, our basic assumption was that recruitment in SHIELD II will be faster because it has broader eligibility criteria. 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. As opposed to SHIELD I, where we have approximately 60 centers that are opened, this is not the case yet in SHIELD II. Now that we are fully focused on SHIELD I, which 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 at the optimum side that is required for just broadening the indication and having it as a Phase 4 trial, as opposed to SHIELD I, which is a Phase 3 trial.
Roy Buchanan, Analyst
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. 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? What’s the plan at 500 patients? Are they going to potentially stop the trial at that point? Thanks.
Dikla Czaczkes Akselbrad, CFO
First, I want to make clear that the 500 patients is not an interim analysis. Everyone is blinded to it, so it’s not something that we can open the data at this stage. It’s an overview into 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 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. Regarding the DSMB, this is very standard. The DSMB has the charter to have the ability to stop a trial based on overwhelming results. This is not unique to ours, but you need to have the level of safety required before they can even look at it. In our case, this was a minimum of 600 patients, 616, if you want to be precise. When I was saying this is too early, that means 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 this is part of their charter to look at it, but first you need to have the minimum patient count in terms of safety.
Roy Buchanan, Analyst
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.
Dikla Czaczkes Akselbrad, CFO
So this is not something that we are going to update except for, of course, the financials and as you mentioned, it’s obvious that we haven’t used it. We did say that we are not going to use it, due to the price we saw in the quarter, and we see no need for that, especially now with the assurance with investors that we have extended our cash runway into the end of next year. There’s no need to use this tool at this level of share price.
Roy Buchanan, Analyst
Okay. Thanks for taking the questions.
Dikla Czaczkes Akselbrad, CFO
Thank you.
Operator, Operator
Your next question comes from the line of Jim Molloy from A.G.P. Please ask your question.
Jim Molloy, Analyst
Hey guys. Good evening. Thank you for taking my questions. I had a quick question on SHIELD II. I know we’ve just been touching upon, and obviously it’s less urgent now. What is the ultimate goal on SHIELD II, I should say, not S II? SHIELD II is 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?
Dikla Czaczkes Akselbrad, CFO
SHIELD II has two objectives. One, of course, is safety. And the second one is to have a broader eligibility criteria to broaden the indication mainly to minimally invasive procedures. SHIELD I is now focused on open procedures, primarily, and SHIELD II will give us the ability to broaden the indication to minimally invasive. We are also looking at whether we will need to include some small portion of additional abdominal surgeries. With our different dialogues with the agencies in Europe and the FDA, this is not necessarily the case, because colorectal resection is viewed as the worst-case scenario in abdominal surgery in terms of infection level, with double-digit infection rates in U.S. open abdominal procedures.
Jim Molloy, Analyst
And what’s the thinking on SHIELD III, the expansion to bone tissue, the sternum surgeries? What does it sort of stand? And what are you expecting to see there now and get answers on SHIELD I?
Dikla Czaczkes Akselbrad, CFO
As we said, this will be something that we will only start and initiate after we have the top-line results from SHIELD I and have our discussions with the FDA on the end of Phase 3 meeting and regarding the labeling.
Jim Molloy, Analyst
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 that?
Dikla Czaczkes Akselbrad, CFO
Thank you for that. From our perspective, this is what we believe is the added value of our PLEX platform. The ability to combine two abilities, anchoring locally and having prolonged local delivery. We think, and also looking at some other local chemotherapy agents in the GBM arena, we believe that this is why OncoPLEX could bring substantial added value due to its size, which is 100 microns, and it’s not migrating from the site of application, combined with the prolonged exposure that can potentially cover all the area of the residual tumor site.
Jim Molloy, Analyst
Thank you for taking the questions.
Dikla Czaczkes Akselbrad, CFO
Welcome.
Operator, Operator
Your next question comes from Boobalan Pachaiyappan from H.C. Wainwright. Please ask your question.
Boobalan Pachaiyappan, Analyst
Hi, this is Boobalan dialing in for Ram Selvaraju. 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?
Dikla Czaczkes Akselbrad, CFO
Sure. We have done a very robust study. Some of it we’ve already provided in previous calls; we have actually done two, but one more recently interviewing 80 stakeholders, half being abdominal surgeons, cardiovascular surgeons, orthopedic surgeons, and the other half being hospital administrators, pharmacists, and PT committees. I think there are many takeaways from it, but two that are worth mentioning from our perspective: the level of interest and understanding, as well as the day-to-day dealing with the costs of surgical site infection were clear from the survey in these anonymous in-depth interviews. The other important takeaway is that you usually see in those new product favor for adoption some level of tension between the surgeons and the hospital administrators—the surgeons tend to adopt new technologies more liberally versus the pharmacies and PT committees pushing back due to budget constraints. This wasn’t the case with our D-PLEX100 survey; we actually saw equal interest, and in some cases even higher interest, from the people responsible for budgeting. This is a very important takeaway for us.
Boobalan Pachaiyappan, Analyst
Okay. Thanks for the clarity there. So obviously your pre-IND meeting is coming up. 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 OncoPLEX?
Dikla Czaczkes Akselbrad, CFO
So I’ll start with the second part. We now have quite a robust preclinical package on safety. It’s worth mentioning that docetaxel, when you administer it locally, is at a very minimal level—almost 1% of what would be administered systemically—which is how small the overall dose is since it is only utilized where it’s needed. There’s no systemic administration that dilutes the drug. We can provide a small overall dose. In terms of the pre-IND meeting this month?
Boobalan Pachaiyappan, Analyst
Yes. The pre-IND meeting.
Dikla Czaczkes Akselbrad, CFO
What do you want to ask about it?
Boobalan Pachaiyappan, Analyst
So the question is, obviously you demonstrated efficacy in rat models and mouse models. I’m just curious whether the FDA might be wanting to know the efficacy of your drug in non-human primates, because of the nexus between the non-human primates and predicting therapeutic response.
Dikla Czaczkes Akselbrad, CFO
This is exactly the reason to conduct the pre-IND meeting and get feedback on our suggested plan and everything that’s already been 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.
Boobalan Pachaiyappan, Analyst
Understood. So along the lines, several experts argue that temozolomide is a paradigm-shifting drug in glioblastoma treatment. In fact, a study showed 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?
Dikla Czaczkes Akselbrad, CFO
There are many drugs that can be used as agents for OncoPLEX, and we don’t have to stop at chemotherapy. This was demonstrated in some past research collaboration that we had—it can also utilize antibodies and be specific. There are numerous opportunities here to start and touch points in cancer. It’s 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 is that this is 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 preclinically, and we are confident that we will continue to see them in clinical studies as well.
Operator, Operator
Thank you. Your next question comes from the line of Elliot Wilbur from Raymond James. Please ask your question.
Hannah Smith, Analyst
Hello, Dikla. This is Hannah Smith on behalf of Elliot. 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?
Dikla Czaczkes Akselbrad, CFO
No changes at all. We are continuing as planned, and we haven’t changed any of the secondary endpoint or primary endpoint.
Hannah Smith, Analyst
Okay, great. Thank you.
Dikla Czaczkes Akselbrad, CFO
Thank you very much.
Operator, Operator
Thank you. There are no further questions. So I would like to hand back to Amir Weisberg for any closing remarks.
Amir Weisberg, CEO
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 lay ahead in the future. 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.