Greetings, and welcome to the PolyPid second quarter 2022 conference call. At this time, participants are in a listen-only mode. As a reminder, this call is recorded. I would now like to introduce your host for today's conference, Bob Yedid, from LifeSci Advisors. Mr. Yedid, you may begin.
Thank you all for participating in PolyPid's second quarter 2022 earnings conference call. Joining me on the call today will be Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid, and Ori Warshavsky, Chief Operating Officer for PolyPid's US operations. Earlier today, PolyPid released financial results for the three and six months ended June 30, 2022. A copy of the press release is available in the investors section on the company's website. I'd like to remind you that on this call, management will make forward-looking statements within the meaning of the Federal Securities laws.
For example, management is making forward-looking statements when it discusses our ongoing clinical trials, our expectations regarding the timing of top-line results from the SHIELD I study and potential NDA submission and MAA filing, potential milestone payments under the license agreement with Advanz Pharma, potential future additional commercial partners, and our ability to maximize the value of D-PLEX100, the commercial potential for D-PLEX100, market opportunity in Europe. The strength of our financial position and our expectation that our cash balance, together with the upfront payment from Advanz Pharma and the proceeds from the Kreos loan, will be sufficient to fund operations through the end of the second quarter of 2023. Forward-looking statements are subject to numerous risks and uncertainties, many which are beyond our control, including the risks described from time to time in our SEC filings. Our results may differ materially from those projections.
These statements involve material risks and uncertainties that could cause actual results or events to differ materially. Accordingly, you should not place undue reliance on these events. I encourage you to review the company's filings with the SEC, including without limitation, the company's Form 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. The conference call contains time-sensitive information and speaks only as of the live broadcast today, August tenth, 2022. With the completion of those prepared remarks, it's my pleasure to turn the call over to Dikla, CEO of PolyPid. Dikla?
Thank you, Bob. On behalf of our team at PolyPid, I would like to welcome everyone to our second quarter 2022 earnings call. I'm thrilled to have the opportunity to provide you with a corporate update today during such a truly exciting time for PolyPid. I will begin with the recent exclusive license agreement we signed with Advanz Pharma for the commercialization of D-PLEX100 for the prevention of surgical site infection, or SSI, in abdominal and cardiac surgeries in Europe, which provide further validation for the significant sales potential of D-PLEX100 and represent substantial value for PolyPid. Under the terms of the agreement, PolyPid is entitled to receive an upfront payment immediately upon signing of the agreement, and additional potential development-related milestones for a total of up to $23.5 million and up to $89 million in sales-related milestones.
We will also supply D-PLEX100 to Advanz Pharma for a negotiated transfer price and receive royalties on net sales in double-digit percentages up to the mid-20s. Advanz Pharma is backed by Nordic Capital, one of the most active and experienced private equity investors in healthcare. Advanz Pharma expertise in marketing hospital-based therapies, mainly after the recent acquisition of Intercept, that more than doubled their commercial and medical teams across major EU countries and the U.K., will prove invaluable in extending access to the D-PLEX100 and delivering this much-needed therapy, if approved, to patients. To understand our excitement for this licensing agreement, it is important to put in perspective the opportunity of D-PLEX100 in Europe. Surgical site infections represent a major unmet medical need in Europe.
SSIs are one of the most common hospital-acquired infections and occur in up to 15%-20% of major surgical procedures such as open colorectal resection. We are also talking about a very significant market opportunity. According to IQVIA, the addressable market opportunity in selected abdominal surgeries in the Big Five European countries represents approximately 3 million annual surgeries. Moreover, there are an additional estimated 450,000 open-heart surgeries in the Big Five EU countries every year. As a result, it is not surprising that the World Health Organization estimates the significant economic burden SSIs represent. The WHO estimates that SSIs result in up to EUR 11 billion of additional hospital costs per year in Europe. This deal is the first step in our strategic approach to commercialize D-PLEX100.
In terms of additional potential collaborations in the U.S. and rest of the world, we remain in dialogue with several other large and mid-sized pharmaceutical companies that we believe would be ideal commercial partners. Like Advanz Pharma, these companies are leading in selling pharmaceutical products to hospitals, often with the current portfolio of marketed products, have strong established commercial infrastructures, exhibit a deep understanding of clinical benefits, health, and health economics in the hospital channel, and maintain strong relationships with the hospital medical and administrative staff. Importantly, there continues to be a high level of interest in D-PLEX100 from additional potential partners.
While there is currently no formal timeline related to executing any additional potential collaborations in the U.S. or rest of the world, our most critical objective is to maximize the value of D-PLEX100 in any potential transaction, as we believe we have done in the Advanz Pharma agreement. If and when we do finalize additional collaboration agreements, maximizing the value of D-PLEX100 will be the key determining factor. With that, I will now provide a brief update on the status of our pipeline. Let's begin with SHIELD I, our phase III study evaluating D-PLEX100 for the prevention of abdominal soft tissue SSI. As we announced in May this year, the Independent Data Safety Monitoring Board, or DSMB, recommended concluding this trial subsequent to the enrollment of 950 patients, which is the minimum number of targeted patients in the study protocol.
This recommendation was based on the unblinded interim analysis by the independent DSMB of efficacy data from the first 750 enrolled patients. The enrollment of the last patient subsequently was announced in late May 2022. As a reminder, the SHIELD I study of D-PLEX100 in the prevention of SSI in abdominal tissue surgery is designed to demonstrate at least a 50% reduction in incisional SSI in the D-PLEX100 treatment arm compared to the control arm, with 90% power to detect the difference between the two arms and an alpha level of less than 0.05. Patients in the study have been enrolled across approximately 60 centers in the United States, Europe, and Israel.
Importantly, SHIELD I is the largest infection prevention trial in colorectal surgery conducted in more than a decade, which we believe only enhance the importance of these data. Full top-line results are anticipated by the end of the current quarter, followed by potential NDA submission to the FDA and European Union MAA filing. Resulting from the breakthrough therapy designation, D-PLEX100 is eligible for rolling NDA submission targeted to start early 2023. Before we provide an update on OncoPLEX and PolyPid financials, Ori will provide color on key takeaways for market research we recently completed for D-PLEX100 in the U.S., and how this work was further supported by the real-world commentary provided by two KOL at our recent webinar focused on managing the cost of SSI. Ori.
Thank you, Dikla. As other partnership discussions progress, we continue our launch preparation for the U.S. market. Last month, we concluded an in-depth market research study aiming to explore current SSI prevention practices and understand how D-PLEX100 will fit within these practices. Our market research indicates that current treatment bundles used by surgeons to prevent SSI are primarily based on surgeons' own clinical experience and institutional protocols and not on strong body of evidence-based studies.
Moreover, all surgical specialties across various types of procedures agree that there is a significant unmet need to reduce infection rates, regardless of how well-controlled their rates are today, since even a few infections can be, and I quote, "catastrophic and devastating." Importantly, surgeons have a fair amount of latitude to create a personal preventative bundle as they see fit for their cases, provided nothing is too outlandish or costly, and their SSI rates stay within the institution or network standards. In the independent market research, when presented with an expected product profile for D-PLEX 100, almost all surgeons who participated in the study indicated that they see room for D-PLEX 100 in their SSI prevention protocols. When asked about the use of D-PLEX 100 at launch, the surgeons indicated that they would likely first use the product on patients with a high risk of infection.
For example, patients that are smokers, have a high BMI or uncontrolled diabetes, before expanding to the broader patient population. The surgeons indicated that approximately 40% of their patients are considered high-risk patients. Much of this market research was further supported by two real-world experts, Dr. Kyle Cologne of USC Medical Center and Dr. Elliot Goodman of Mount Sinai Health System, who participated in our recent webinar on the cost of managing SSI last June. Dr. Cologne provided a surgeon's view from a general hospital perspective on the cost of managing SSI, and Dr. Goodman discussed the impact SSI has on quality measures and performance from an IDN perspective. Dr. Cologne noted that all hospitals are looking at infection rate data and comparing their performance to peers.
From a financial perspective, avoiding complications, including infections, means that the hospital can keep more of their reimbursement money received from payers. Dr. Colon believes that the use of D-PLEX100 will be appropriate for approximately half of surgical patients. Dr. Goodman noted that Mount Sinai's infection control team tracks infection in real time, and infection triggers a detailed investigation because it has to be reported to the State Department of Health. The inspection team will want to know if every aspect of the SSI prevention bundle was followed. Every three months, Dr. Goodman's institution is reviewing internal data related to compliance with prevention bundles. This includes drilling down to individual doctors' practices and understanding why certain surgeons may not be following these bundles. Moreover, infections and readmissions are part of the annual faculty evaluation. As Dr.
Goodman put it, surgeons are called to the principal's office if their infection rate is over the department's baseline. Importantly, infections are being increasingly reported and rates are rising due to the strict monitoring process currently in place. Collectively, we believe these trends and insights indicate strong commercial potential in the U.S. for D-PLEX100. With that, I will hand the call over to Dikla.
Thank you, Ori. As we prepare for the targeted NDA submission and potential commercialization of D-PLEX100, we also continue to make progress with OncoPLEX, our lead intra-tumoral product candidate in oncology, applied as a paste on a tumor resection area during surgery. Most recently, animal studies demonstrating that locally administered OncoPLEX potentially decreases the likelihood of tumor recurrence, which reduce side effects compared to systemically administered chemotherapy agents, were published in an abstract in the ASCO 2022 meeting abstract book. Switching gears, I would like to discuss changes to our board and management team. I'm pleased to announce today that I have joined PolyPid board of directors. Additionally, Jonny Missulawin has been promoted to Senior Vice President of Finance. He has been with PolyPid for eight years in roles of increasing responsibility in the finance group, most recently as Director of Finance.
Prior to joining PolyPid, he was senior editor at Ernst & Young. Jonny earned an MBA from Tel Aviv University in Financial Management, a BA in Accounting and Economics from Bar-Ilan University, and is a certified public accountant in Israel. With that, I will now review our financials. From the perspective of our balance sheet, you will recall that in the first quarter we obtained an up to $15 million non-dilutive secured term loan facility that broadens our financing options and provides us with access on a non-dilutive basis to significant additional capital, which bolsters our ability to invest in our commercial capabilities for D-PLEX100, as well as fund further advancement of our unique PLEX technology platform. As a reminder, the loan facility is comprised of three tranches in the amount of $10 million, $2.5 million, and $2.5 million, respectively.
The first tranche of $10 million was drawn in April 2022. The second tranche of $2.5 million was available once we obtained results from the interim analysis of SHIELD I. Drawn down of the third and final tranche of $2.5 million will be available subject to obtaining positive top-line results from the SHIELD I trial or if other conditions are met. As of June 30, 2022, the company had cash equivalents and short-term deposits of $23.8 million, excluding the second tranche of $2.5 million from the loan, which was drawn in July 2022.
As it relates to our balance sheet, during the second quarter of 2022, we sold approximately $300,000 worth of ordinary shares from our existing at the market facility. This action, combined with the upfront payment from Advanz Pharma and the loan agreement with Kreos Capital, extends our cash runway throughout the end of the second quarter of 2023. Investors should note that this cash runway excludes additional potential development-related milestones from Advanz Pharma, as we announced last week, including a potential payment of up to $12.5 million contingent upon positive top line result of the SHIELD I phase III study and additional development related milestone of up to $8.4 million. Now let's turn to our income statement.
Research and development expenses for the three months ended June 30, 2022 were $8.4 million compared to $7.4 million in the same three-month period in 2021. The increase in R&D expenses resulted primarily from the increased costs and activities related to the accelerated recruitment of the final patients in the SHIELD I phase III clinical trial. Marketing and business development expenses for the second quarter of 2022 were $923 thousand, up modestly as compared to $739 thousand for the same period of 2021. General and administrative expense for the second quarter of 2022 were $2.2 million compared to $2.4 million recorded in the prior year period.
For the second quarter of 2022, the company had a loss of $11.1 million as compared to $10.5 million in the prior year period. This was primarily driven by our strong rate of patient recruitment in the SHIELD I phase III clinical trial. We will now open the call to your questions. Operator?
Thank you. If you wish to ask a question, you will need to steadily press star one and one on your telephone and wait for your name to be announced. 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.
Okay, great. Thanks. Good morning, and congrats on all the progress. The license agreement with Advanz in Europe, just talk more about their capabilities in the hospital space in Europe. What countries will they focus on initially, and the market opportunities in those countries? When are you expecting to file in Europe? Will it be the same exact time as the U.S.? What are the criteria there?
First of all, good morning, Gary. Thank you for joining us. Advanz Pharma is a Nordic Capital-backed company. They were bought about a year ago by Nordic Capital for $850 million, and they are focused on the hospital space on specialty products. They also have two anti-infective specialty products. That's where this is their sweet spot. This is where they are strategically targeting. They've built a very nice sales force and market access force in Europe, only in Europe. They quite dramatically increased their capability, doubled their sales force in the last few weeks, buying all of the out-of-U.S. business of Intercept Pharmaceuticals. Now they are with a few hundred sales reps and market access personnel in Europe.
Of course, more so in the Big Five countries and in Western Europe versus Eastern Europe. Very much from our perspective and from what we've learned and worked together in the last few months as part of the negotiation, very much focused on where we wanna be and open the doors for a product like D-PLEX to the right patients and to the right physicians.
Okay. The filing, the timing of that.
Right. Thank you.
Is that gonna be the same time as the U.S.? Yeah.
The filing process in Europe is a bit different in time. The filing is expected to be more or less the same time, maybe slightly after, but generally we're looking at the same time of filing and the way the review time is distributed differently. Again, both approval and filing should be more or less at the same time. We're talking about-
Okay.
Not more than a quarter difference in terms of the filing and probably then the review.
Okay. For the rolling submission in the U.S., if it's initiated in early next year, just when will it be completed? You know, are there any gating factors on the CMC side? Is that all buttoned up? You know, is there gonna be any additional data, clinical data outside of SHIELD I that you're gonna supplement in that package?
I'll start with the latter part. Yes, we will be submitting SHIELD I and also our phase II trial, which is part of our clinical development agreement with the FDA, that the supporting data will be the phase II that they've already seen and the phase III. This will be part. The rolling submission is expected to start early in the year, and our assumption is that not more than six months from the first module, we should be submitting the last module. Everything is in process. All those modules are in process and are getting ready to be submitted. There are some CMC, as you mentioned, aspects that are required in terms of having six months stability.
I'm sure everyone on the call remembers that last year we increased our manufacturing capacity and more than doubled the capacity. In the last few months we validated the facility and got to the stage where we can start get prepared for, again, for GMP manufacturing and have a stability process in place. This is again on track. You're right that this will probably be the last model to be submitted.
Okay, that's helpful. The last question, probably for Ori. Just, you know, when you think about potentially launching in the U.S. and how you're preparing for that, it sounds like there are partnership discussions ongoing. Do you think it's more or less likely that you'll have some sort of commercial presence in the U.S.? You know, how big of a commercial presence would you be willing to have? You know, what are some of the different scenarios that you're thinking of in terms of co-promote or just completely licensing out the opportunity in the U.S.? Thanks.
Thank you, Gary. First off, good morning. I think we believe that it's important for us to keep some level of control in the U.S. on the product in the U.S. market. It's the biggest market for us. That's where our focus and our attention is. The strategy is to find a partner for co-promote, not an out-licensing. The structure of the deal will not look like the deal with Advanz. How this would look like? A lot of it will depend on the partner. But we do see. First of all, we bring the manufacturing into this discussion since we're backward integrated and manufacture our own product.
We bring the knowledge of the product. We bring some of the medical knowledge around the product and the need. We are developing a lot of the capabilities and a lot of the pre-launch activities that are needed to launch. As time progresses, we build more and more around this. I think strategically it's important to us to control or to have some level of control on pricing. Definitely on the brand strategy, how the product is positioned, so who we call on, how we extend the label and so on. At the end of the day, it will be dependent on the partner.
We are looking for partners that know the way around the hospital, around P&T committees, around the surgery suite. Depending on what the partner comes in, I think this is how the structure will end up.
Okay, great. Thank you, guys.
Thank you.
Thank you. We will take our next question. The question comes from the line of Brandon Folkes from Cantor Fitzgerald. Please ask your question.
Hi, thanks for taking my questions, and congratulations on all the progress. Maybe just following on from the question on the E.U. opportunity. Can you just talk about how infection rates may differ by country by country in Europe and how this compares to the U.S.? Similarly, in terms of standard of care in the E.U., how does that compare to the U.S. and maybe between countries?
Yeah, sure. In general, you would see in Europe, in major surgery 15%-20%, especially in such as open colorectal procedure, you'll see 15%-20%. Generally, our understanding, looking at the historical data, that infection rate in Europe might be slightly higher than in the U.S.. Again, in an average, on a very broad basis, when you look at specific countries, you could see difference. We don't experience it so much yet, but we'll need also to see in our phase III that there is what's the difference between the different countries within Europe. I can tell you that what we saw, and also this was seen in market research that was done as part of this deal. You see the level of infection everywhere.
It's not that you will say, "Well, in the U.K. they don't have surgical site infection. It's all only in Eastern Europe." This average and the numbers of the 15%-20% that occur in major surgical procedures, this is in all Europe. Obviously, there are some slight differences between countries and as you will see in the U.S. also between hospital to hospital. It's not just geographical.
Great. Thanks. Maybe just one more question, if I may. Can you just remind us of the expectation of the D-PLEX label initially? Particularly I did hear you talking, you know.
SHIELD I and the Phase II is once agreed to be submitted. I mean, SHIELD I, beg your pardon, and the Phase II. Given the exposures in SHIELD II, do you think there's any potential at that pre-NDA meeting for the FDA to say, submit the exposures you have in SHIELD II, and we could potentially explore a broader label at approval? Or is that very much put to the side and we should think about it as an sNDA? Thank you.
Thank you and thank you. This is a very good question, and we are putting a lot of efforts into preparing for that. We are aiming for a broad abdominal indication, both with the FDA and the EMA. Sorry, MAA. This is what we are aiming to. We believe that with some indication that we have received and the data that we have gathered, this is a reasonable target. We are also preparing a backup. And there are some slight differences between Europe and the U.S. on that in terms of what was already agreed with us and what we expect will be the path forward.
SHIELD II, as you mentioned, this is very much a backup that, if needed, could be submitted in few months' time, post NDA approval to expand to a broad label. We're aiming for a broad label. There is a possibility that we will get that based on what the data that will be submitted at the NDA submission. We already have 200 patients in the SHIELD II, and we could add additional few hundred, one or two, to get this broad labeling for a broad abdominal indication. This is very much something that we see feasible within the short term. Later on, there is a plan also for expanding beyond just broad abdominal on sternal and other orthopedic indications. Again, I think it's a bit too early to discuss it.
We'll wait until the end of this quarter for the top line, and then we can give a more reasonable plan going forward.
Great. Thank you very much for taking my questions.
Thank you.
Thank you. We will take our next question. The question comes from the line of Elliot Wilbur from Raymond James. Please ask your question.
Hi, guys. This is actually Michael Parolari in for Elliot. Thanks for taking my questions. To start off, I know you guys detailed a little bit of the background about your commercial partner in Europe, but is there any key different perspective that Advanz is bringing to the table in terms of pricing, reimbursement or targeting that's impacting the way that you view the EU opportunity and how you might view the U.S. opportunity?
Maybe Hi, Michael. I can take this one. When you look at pricing, to remind everyone, when we tested pricing in the U.S., we looked at a range of somewhere between $200-$600 per vial with a and further tested $400 per vial as you know, with proxy to some of the other locally administered products like EXPAREL and Zynrelef. We saw that at $400, what came out from research is kind of broad no restriction use. This is what we heard in the research from surgeons. Our assumption is, I'm assuming I'm sure you see this in your research as well, that the prices in Europe will be slightly lower. That's our going assumption.
You know, this as we work on our pre-launch activities and advance the same, we'll be able to kinda sharpen this number more. I think as an assumption for now, slightly lower than 400 is probably a good assumption. In terms of the access point, so first, just from a let's call it deal structure, Advanz is responsible for getting a or doing all the commercial activities, including the access and reimbursement. That said, we are working together. We will work together on generating some of the health economics piece, which, you know, as we know, is a bigger driver in European countries than in the US. We're collecting the data as part of the trial.
There's a planning phase for the pharmacoeconomics piece, which will be kind of developed and executed together with Advanz Pharma.
Got it. Thank you. That's helpful. Looking towards the expected top-line readout on SHIELD I, obviously expecting a readout on the primary endpoint, but should we also be anticipating any updates on any of the key secondary endpoints along with that readout?
Yeah. We are expecting to have both the top line and the first secondary endpoint. We will be able to update on both the first key secondary endpoint and probably within a few months time, we'll also have the full CSR. The primary endpoint, just as a reminder, it's both infection and mortality, and the key secondary is just infection.
Got it. Thanks. Last one from me is, I know you guys provided an update on the OncoPLEX program in your prepared remarks. Just wondering if we should expect to see any further progress points before the year-end, and how you guys are thinking of evolving that program as you get closer to commercialization of D-PLEX and, you know, being able to shift some attention there.
We were very much both in terms of resources and attention very much focused as a company and as a relatively small company on, of course, D-PLEX100 and this large trial, and also now people here are really very much concentrated on cleaning the data and meeting the timeline, as well as the day after the top line, which will just trigger a very robust plan that will require for approval and manufacturing. All of this is happening here in the last two years. Obviously for those reasons, OncoPLEX has progressed very nicely. I must say on a personal level that I hope we will be able to progress it much more aggressively.
This is what we're hoping to be able to, that having the top-line results, again, very soon, as you said, will enable us to have more effort and more time on OncoPLEX. It's hard for me to say at this stage if we will have substantial update before the end of the year, but I'm sure that we will be able to share more on the plan and the next steps before the end of the year.
Got it. Thank you very much. That's all from me.
Thank you.
Thank you. We will take our next question. The question comes from the line of Balaji Prasad from Barclays. Please ask your question.
Hi. Thanks for taking my question. This is actually Michaela on for Balaji. Just two from me. I guess just on the competitive side of things, how have there been any new developments with similar use case to D-PLEX? Or I guess any updates on potential timing of new entrants. Then just circling back to the ongoing partnership conversations, I guess just when can we expect an update on this?
Ori will take the competition part, and I will relate to additional dialogues and discussions on commercialization.
Yeah. Hi, Michaela. On competition, first maybe let me make the point that what we see in the market today, even the existing players don't have that level of evidence, the size of the trial, the significant data that we expect to get from SHIELD I. Really, when you compare what the type of prevention measures that exist today, really they don't compare to what we have from a level of evidence. That said, as just to remind, the trial is D-PLEX on top of standard of care. At least as a first go, none of the prevention measures that exist today are direct competitors.
We're not changing a doctor's behavior or taking anything away from the tools or the procedures in their bundles that are used for preventing SSI. Looking into pipelines, as far as we can tell, we don't see anything in the FDA databases or in literature, everything that's in clinical trials. There are small pre-clinical attempts in SSI prevention, but nothing that is really in the near-term horizon, even in the mid-term horizon.
With regards to the aspect of timing on future collaboration, commercialization, I think that we have the track record on giving the sense of the actual presence of those. Obviously being less than two months from top line, obviously we do not expect to be able to announce additional partnership this summer. What I can say, and again, this doesn't apply on the actual timing, we do think that, and we sense it already that this partnership that is already established will accelerate some of the dialogues and the discussions that we are in. I think that's the only thing I can say at this stage on timing.
Perfect. Thanks so much.
Okay.
Thank you. We will take our next question.
Please stand by. This question comes from the line of Roy Buchanan from JMP Securities. Please ask your question.
Thanks for taking the questions. First one, Dikla, you mentioned the powering and the alpha less than 0.05. I'm just wondering if you could tell us what the minimum threshold is needed for the primary endpoint to be statistically significant.
The actual one, you mean?
Correct.
Below the 0.5? It's 0.4788.
Zero.
0.048. Yes. Very much, the penalty that we had to pay for the interim, as you can see, is very minimal. 0.048. Below 0.048. 0.048, sorry.
Okay, great. Thanks. Sorry to kinda stretch beyond the discussion you just had on OncoPLEX, but last call, I think you mentioned, you know, potentially partnering OncoPLEX as well as the platform. I know you've had partnerships with other companies looking at their molecules before. I just wondered if you could maybe look out in the future a little bit and any thoughts on partnering the platform more broadly, maybe something like, hey, what Halozyme does, partnering with proprietary molecules. Thanks.
Right. I think that's really when we look at our vision and the vision that we all here in PolyPid believe is feasible and possible for the PLEX platform and the approach, this is where we are aiming. To have not just our own proprietary pipeline, but also collaborating with novel molecules, peptides, antibodies, could be also additional things. This is really part of our vision and the way we would like to explore or to extract the most value from the platform and from the approach. I think that this is something that will take additional time. If I need to kind of give you investors the roadmap to that, I think first we'll have the top line.
We'll have some additional progress and some additional preclinical data from our oncology program, from the OncoPLEX, and this will open the door for those kinds of collaborations and licensing of the platform. As opposed to what we had probably six, seven years ago, which was purely research, they will be much more mature in terms of the stage and the commercial aspects of those collaborations.
Okay, perfect. Thank you.
Thank you.
There are no further questions, so I'd like to hand the conference back to the speakers for closing remarks.
Thank you for joining our second quarter earnings conference call. I would like to emphasize how excited we are about the progress we have achieved to date. As we transform from a research and development company to a commercial organization, as well as potentially earning milestone payments and royalties from D-PLEX sales by our European partner, we remain grateful to our team members and all of our external partners for their commitment to our mission and their support in continuing to advance toward achieving our goals of bringing D-PLEX100 to healthcare providers and patients as quickly as possible. We look forward to speaking with you again shortly on our next call.
This concludes today's conference call.