Good morning, and welcome to Moderna's conference call. At this time, all participants are in a listen only mode. Following the formal remarks, we will open the call up for your questions. Please be advised this call is being recorded. At this time, I'd like to turn the call over to Lavina Talukdar, Head of Investor Relations at Moderna. Please proceed.
Thank you, Operator. Good morning, everyone, and welcome. This morning, we issued a number of announcements that we'd like to discuss on the call with you today. You can access the two press releases and statements as well as the slides that we'll be reviewing by going to the investor section of our website. On today's call are Stéphane Bancel, our Chief Executive Officer, Stephen Hoge, our President, Tal Zaks, our Chief Medical Officer, and David Meline, our Chief Financial Officer. Before we begin, please note that this conference call will include forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Please see slide two of the accompanying presentation and our SEC filings for important risk factors that could cause our actual performance and results to differ materially from those expressed or implied in these forward-looking statements. We take no obligation to update or revise the information provided on this call as a result of new information or future results or developments. With that, I will now turn the call over to Stéphane.
Thank you, Lavina. Good morning or good afternoon, everyone. This morning, we issued two press releases and also posted the company statement on our website and social media. We thought it would be helpful to organize a short call to summarize briefly each press release and the company statement and make ourselves available for questions. First, RSV. We announced that we have regained 100% of the commercial rights to develop RSV vaccine in the elderly population from Merck. Merck will focus on the RSV antibody program. We will now have a right to advance RSV vaccine in the elderly. As you recall, until now, we only had the rights for pediatric setting. On this topic, we are happy to share today that mRNA-1345, our pediatric RSV vaccine, is now dosing healthy participants in its phase I study in the U.S.
This is Moderna's 11th infectious disease vaccine to enter the clinic. With these commercial rights for the elderly population, we need to do some work now to decide how we maximize the commercial opportunity for the elderly for RSV, either as a vaccine for RSV only or in combination with other respiratory virus vaccine like COVID-19 or flu. I would like to thank the Merck team for a great collaboration. Secondly, we announced this morning that Moderna has signed and received a new award from DARPA, which is part of DOD, the Department of Defense, for up to $56 million. This new award aims at developing a factory in a small container, a cube of 6 ft by 6 ft by 6 ft, or 1.8 m, for people outside the U.S.
This factory in a container is aiming at fighting future pandemics and outbreaks, where you could literally put a container under a chopper and take it anywhere you want in the world to make mRNA on demand. This is part of a DARPA NOW, Nucleic acids On-demand Worldwide initiative. I would like to thank the DARPA leadership for their trust and their continued support in Moderna since our first DARPA grant in 2013. Finally, as part of our leadership in transparent communication during this pandemic, we have shared that we will not enforce our COVID-related patents during the pandemic period. We will provide licenses to our patents for COVID vaccine post the pandemic phase.
Like most companies involved in the active response to a pandemic, we are very proud that our mRNA technologies are poised to help in the fight against this pandemic. I would like to thank our Moderna scientists for 10 year of innovation and the Moderna IP team for their work in getting this foundational patent issued. With that, I will hand it to Stephen to give you more details on these three topics. Stephen?
Thank you, Stéphane. First on slide four on the RSV programs. As Stéphane mentioned, we've regained the rights to the adult RSV program that had previously been with Merck. Merck was going to complete the phase I study of their current candidate, mRNA-1172, and then transfer the program to Moderna. As a reminder, Moderna's advanced three different RSV vaccines, which are shown on the table on the slide. One of the key differences among these are the different lipid nanoparticle technologies they use. mRNA-1777, the first one, used an industry standard and licensed LNP. mRNA-1172 used a Merck proprietary LNP, and our own candidate, mRNA-1345, uses our own proprietary Moderna LNP that is the same as we use in our COVID vaccine and CMV vaccines.
The mRNA construct encoding for the RSV F protein in mRNA-1345, our candidate, is also engineered for enhanced expression. Now, recall that earlier this year, we announced that mRNA-1345 was actively recruiting participants into a phase I trial. I'm happy to announce today that we've actually initiated dosing in that trial. The phase I trial is an age de-escalation trial, as we intend to develop mRNA-1345 in the pediatric setting. We announced this new development candidate just back in January and announced the open IND just this past month. It's really terrific progress by the team to have already started enrolling.
We're excited now to have the ability to take this candidate into the older adult population, where reducing RSV infection is also a significant unmet need. With today's announcement, it will allow Moderna to evaluate that path forward for mRNA-1345, alone or possibly in combination with other respiratory viruses. That's an important and vulnerable segment of the population that we hope to help. I'll turn it back over to Stéphane to briefly cover DARPA.
Thanks, Stephen. On the DARPA initiative, DARPA is focusing on developing a medical countermeasure manufacturing platform. We're very excited to announce this new partnership with DARPA to enable small-scale, rapid mobile manufacturing of nucleic acid vaccine and also therapeutics. This builds on our relationship with DARPA following our chikungunya antibody therapeutics. The goal of this mobile manufacturing technology is to be able to either produce on-site remotely vaccines or therapeutics a la chikungunya antibody therapeutics. The goal is to deliver near-instantaneous protection and treatment to both military personnel and local populations in the case of outbreaks.
What DARPA envisions is a design of a manufacturing unit capable of producing hundreds of doses of medicine in a matter of days in a small 6 ft by 6 ft by 6 ft, or 1.8 m by 1.8 m by 1.8 m, container in remote locations around the world. We're very excited about how this technology will help us take mRNA closer to patients and be able to do more things, especially in case of outbreaks or potentially, in the military for wars. With this, I turn back over to Stephen for IP.
Thanks, Stéphane. Finally, this morning we also issued a statement regarding our intellectual property related to our vaccine, mRNA-1273, and potentially related to other vaccine development for COVID-19. The statement is here on the slide, and I did want to highlight just a few points. As many of you know, since our inception, we believe that mRNA has the potential to be a new class of medicine, and we've worked tirelessly to try and turn that belief into a reality. With the financial support of our investors, we've created new technologies and advanced discoveries in development candidates through clinical trials over the past 10 years. Many of those discoveries along the way now form our portfolio of significant intellectual property. It's a key asset for Moderna as we become a commercial company and allows us to protect innovation and continue investing in it in the future.
Our intellectual property is a foundation of our success, and we do believe it is differentiating. Today we made public on our website a selection of some of the representative patents that pertain to 1273, our vaccine against COVID-19. Now, we are pleased that mRNA-based vaccines may play a big part in the potential response to the pandemic. We're quite proud of that progress. During these extraordinary times, with the continuing pandemic, it is our desire to bring this pandemic to an end as quickly as possible.
As such, we announce today that we will not enforce our COVID-19 patents against those making vaccines to stop the pandemic. Further, to eliminate any perceived barriers, we'd be willing to extend licenses for the post-pandemic period. Now, Moderna's really proud of our mRNA technology. We're really proud of our strong intellectual property portfolio, and we are equally proud that it is now poised in our hands and perhaps in others' hands to be used to help end this current pandemic. With that, I believe we'll turn it over to the operator for any questions.
Thank you. As a reminder, if you'd like to ask a question, please press star then one on your touch-tone telephone. To withdraw your question from the queue, please press the pound key. Please standby as we compile our Q&A roster. Our first question comes from Matthew Harrison with Morgan Stanley. Your line is now open.
Great. Good morning. Thanks for hosting the call and thanks for the information. I guess two things from me. First, on the Merck decision related to 1172, can you just maybe give us a little bit more background here? You seem to be emphasizing the differences in the LNPs. Was there a tolerability issue or an expression issue with that LNP, or was this Merck's lack of interest in RSV as a target? Maybe you could just expand on that. That would be helpful. Second, on the IP, you've made some pretty broad statements. I'm wondering if you're willing to be maybe a bit more specific and just comment on, do you think you have rights that cover other mRNA vaccines as part of your IP estate related to COVID specifically? Thanks.
Thank you, Matt. Yeah, let me try and take those two in sequence. First on the Merck 1172 decision and regaining the rights. I defer you to Merck's own sort of rationale for why RSV as a monotherapy vaccine may not be of interest to them, and why they're instead focusing on the antibody program. I think I'll provide my own sort of response to that, and it's consistent with what we said in the past, which is, we actually think what will be differentiating about respiratory vaccines in the future will be combinations. If you look at RSV monotherapy vaccines as just a competitive point, there are multiple vaccines that are further ahead in pipelines in large pharmaceutical companies.
For those reasons, from a strategic perspective, it obviously, from our viewpoint, would make more sense to come forward with a differentiated vaccine, which might be a combination of different viruses. That's actually the approach we're pursuing, as you know, in our pediatric vaccines already. As you know, we've talked about, both at our vaccines day and even last month, that our intention is to combine our 1345 RSV vaccine with other respiratory viruses in a pediatric population. As a strategic point, we'd probably be doing the same thing in the adults going forward. On the question of intellectual property, so we do think we've made some pretty significant inventions and discoveries in the field of infectious disease vaccines, and we've covered that in the past.
As further evidence of that, I think we do highlight today a number of issued patents, composition and matter patents in the United States that cover our COVID-19 vaccine, mRNA-1273, and all of which are issued composition matter patents that we think might be relevant for other mRNA vaccines. Only those companies would know if they were relevant or not, because we obviously don't have full transparency to what people are doing. Under normal circumstances, we likely would be protecting our product.
If this were not a pandemic, we would expect to use our intellectual property, which is one of the ways that you protect innovations in this country and globally, to protect our product going forward. These are not normal times. This is a pandemic. I think we feel it is our responsibility to be upfront and transparent of the decision we've taken that we're not going to be using those patents and trying to enforce them against others.
Thank you. Our next question comes from Ted Tenthoff with Piper Sandler. Your line is now open.
Great. Thank you very much, and I applaud the [IP] decision. That makes a lot of sense. I'll ask about the new announcement with DARPA. This is a pretty interesting approach. Could you give us, for example, like I'm envisioning something like an Ebola outbreak or something like that in Africa. Is there a risk by sort of decentralizing the technology that it could be spread outside of your hands? I just want to kind of think through that a little bit more. Thanks so much. Really cool program.
Yes, Ted, this is Stéphane. Thanks for the question. I think if you want to really think about the vision that DARPA has, it's kind of a Nespresso machine for making medicines, where basically you have a self-contained unit, where you basically load raw materials in self-contained kind of containers, where you could have a sequence coming remotely through a cellular connection or something like this. There's a lot of components that actually through robotic digitalization, you can control without the user being able to know. It's a bit like you're buying a Nespresso machine. Yes, you can take it apart on a weekend if you want to make another one. We think that there is actually a lot of ways for us to still control the process remotely.
We feel comfortable that this is kind of a right thing to do. We're going to be learning a lot. Think about all the investments in technology that needs to be made through that grant in term of microfluidics and other pieces, which will help us not only for that, but also in term of just scientific learning. We think it's a very exciting project that we hope in case of a future outbreak we could actually, we or global we, react much faster if such a device would exist.
Yep. Well, that would be a great thing. Thanks so much, Stéphane.
Thanks, Ted.
Thank you. Our next question comes from Salveen Richter with Goldman Sachs.
Perfect. Hi, everyone. It's Sandra. I'm for Salveen. Just wondering if you could speak more on the opportunity for the RSV vaccine in a combination setting, and what are your specific development plans there? Thanks so much.
Thank you for the question. As Stéphane said, we've regained these rights, we're beginning a strategic process to define better what our specific development plans will be. I can't answer that question today. I can hit the broad strokes of what we've said in the past and what we think will apply to that strategy. If you look at the burdens of disease for respiratory viruses, in particular things like RSV, but also flu and human metapneumovirus are ones we'd point to. The burden of disease is borne in the young and in the elderly, particularly those 65+ . In that sense, it is populations that are at high risk of COVID as well, which is another respiratory virus.
As you look at what might be necessary in those populations, over time, what happens is you're functionally immune to a virus like RSV for much of your life, your adulthood. As you age, through immunosenescence and other things, you'll start to lose some of that functional protection. A booster vaccine that allows you to boost up those neutralizing antibody titers and hopefully stave off a severe infection of RSV can be the difference, we hope, between life and death for those who are immunosenescent and maybe become infected. As we've talked about in the past, there is an unfortunately large number of deaths in this country every year, and globally, in that 65+ population. Now, RSV is not the only virus that causes that kind of mortality and morbidity, hospitalizations, and deaths. There are other viruses associated with it.
One of them is human metapneumovirus. It's a cousin virus of RSV, has been described by us in the past, and as you know, it's a component of one of our vaccines in the pediatric space. The other is that we've talked a lot about recently are influenza, we announced last month that we're going to be going forward with an influenza program during our R&D day, and coronavirus, which we're all obviously acutely aware of. We have a vaccine candidate there, as you all know, in phase III with mRNA-1273. The specific combination of those respiratory viruses that might make sense as a single respiratory booster for elderly populations, we haven't landed on yet as a company.
We look at those four opportunities, and we clearly see a huge amount of morbidity and mortality, unmet need, and an opportunity to create a truly differentiated product that uses the best of mRNA technology. Those things that we've talked about in the past are the ability to combine antigens into multiple different vaccines. In fact, we already have a respiratory virus vaccine in HMPV and PIV3, which is a combination. The ability to do really complicated antigens, and the capital efficiency of it. Those three points that we've emphasized in the past are things that we think allow us to perhaps develop a substantially differentiated respiratory vaccine here. We'll provide an update on RSV specifically and how we would intend to move forward from a development perspective, but hopefully that gives you a sense of how we're thinking about it.
Thank you. Our next question comes from Michael Yee with Jefferies. Your line is now open.
Thanks. Appreciate the update this morning. Appreciate all the updates on RSV, et cetera, but maybe I could just ask a question on more nearer-term things as well. Obviously, there were some EUA guideline changes, perhaps, or an update, and also some people are filing early on a rolling submission to Europe. Maybe you could just comment about the implications of any of that for COVID. Secondly, as data starts to come out soon, maybe you could just comment on your confidence that either mRNA vaccines may be differentiated between each other, or more importantly, as a single-dose injection phase III has also started, whether you truly believe your product will be differentiated than some of these others that are coming shortly down the pipeline. Thanks.
Thank you for that. This is Tal. Let me take those in sequence. EUA guidance, I don't think there has been a material change as far as I understand it on the FDA's position. There's been an attempt to obviously politicize the back and forth. If you look at the documents that have been posted to VRBPAC, and if you listen to Peter Marks, he's clearly been on record saying, "Look, this is a guidance. This is what we hope to see, but a little data will go a long way in that once you cross your interim, we should have a dialogue on the totality of the data." The proof of that is in the pudding. Our protocol is on the web. You can see it. The interim analysis triggers are there. If FDA had mandated a minimum requirement, they would have asked us to change the protocol.
We're keenly aware of the guidance. We're working with the FDA to make sure that when we get our data, we can simultaneously or in very short order thereafter, provide them the totality of safety data as well as efficacy that they would like to see to make the informed decision on an EUA. I think we're on the right path there, and I don't think there's been any major shift. Your question on Europe is highly relevant. We intend to start our rolling submission there as well very soon. We've been in dialogue with the Europeans, and our understanding, based on recent comments that they've made, is that we would expect the same package that's being submitted in the U.S. to be relevant for Europe. Obviously, the relevant part for Europe is when you get the approval, not when you start the file of rolling submissions.
The clock is determined by the completion of it. I think we're in a very good stead there and hope to be able to provide additional updates shortly. In terms of our confidence in the data and our ability to differentiate, look, I think one of the beauties of an mRNA technology, let me start there, is that we can boost because the immune system doesn't see the mRNA. It only sees the protein. I think other platforms, the viral ones, the recombinant viruses, are obviously limited by both pre-existing immunity and then once you dose once, the immunity that you then generate.
It is possible that within their first dose, they could get to some level of neutralizing antibodies that would be protective. For the sake of all of us, I hope that's the case. I think if you look at the magnitude of the antibody response, it's pretty clear that every vaccine that is able to prime and boost, upon that boost assures a higher level of neutralizing antibody, assures that nobody's left behind. If you look at our data, we're able to mount neutralizing antibodies across all age groups and in everybody. I think that a higher level and consistency of effect, for me, I'm optimistic that it will bode well into the ability to protect from disease.
The proof will be in the pudding, and I think one of the more difficult elements will be for any of us to understand the durability of protection of any of these vaccines, because all of the vaccines that will demonstrate efficacy will do so within the first few months of launching. I think given that it's a pandemic, we'll all do the right thing, which is try to protect the population, and I think it'll take months and maybe even longer to understand some of those differentiating factors. All that being said, I do expect in the first crop of efficacy data that you're going to start to see some daylight between different vaccines. Over.
Yeah. Maybe, Michael, just to add a few words to what Tal just said. As you know, and we talked about it in the past, we have focused, including when we pick the dose of a product on the performance of a product. We said we want to use all the investment in science that we have made, the new lipid manufacturing process, to ensure the best product we can to help as many people as we can that are at higher risk. Tal talked about the elderly. As you know, because a lot of data has been published from phase I now, all the mRNA vaccines or adeno products do not have a consistency we've had. I remind everybody that we had all participants in the young population and in the elderly mounting an immune response, a high level of antibody.
There's no reduction, as you saw, in the elderly versus the young, unlike other platforms. If we look at what's happening in the antibody space, recently with Lilly and Regeneron, there's good clinical suggestion that antibodies and neutralizing antibodies are really important for protection. When you think about those are one or two antibodies, and when you vaccinate people, you basically generate a lot of different antibodies through the immune system. When you connect all those dots, I continue to believe that we could potentially have one of the best, if not the best, vaccine on the market.
Yeah. Thank you.
Thank you. Our next question comes from Gena Wang with Barclays. Your line is now open.
Thank you for taking my questions. I have three quick questions. The first one is regarding COVID-19. Just wanted to get your latest update. I understand it's changing basically every week. Is the first interim still on track to report sometime in November? If you do not get the interim, should we still be expecting roughly eight weeks to see the second interim? My second question is regarding the mRNA-1172 program, the RSV program. When you take back, will you use Merck lipid nanoparticle, or will you switch to Moderna's lipid nanoparticle?
What is the difference between these two lipid nanoparticle? My last question is regarding the manufacturing. I think you mentioned in the past you are capable of doing the lyophilized since all the other programs is using lyophilized. The DARPA program, was that for - 20 storage, or was that for lyophilized? For the COVID-19, are you planning at some point to produce lyophilized production?
Gena, this is Tal. Thanks for the question. Let me just take the first one. The first interim is on track for sometime in November. We're looking at the epidemiology within our sites. I think our expectation now is that the cases that we're starting to see on trial are tracking the cases in those zip codes. I think by and large, we are on track if we've been recruiting the right subject into the trial, I think all of us.
I think the delta between first and second interim, I think it's in the order of four to eight weeks. It's hard. I think it's probably going to be less than eight weeks, maybe more than four. It'll depend on the shape of the pandemic, of course, in the coming weeks. We live in this paradox where the worse it is out there, unfortunately for people, the quicker the readouts for the trial. Let me defer to Stephen on the LNP.
Yeah. Thank you, Gena, for the questions. We will focus on 1345, our LNP going forward from an RSV perspective. We think the advantages of that are obvious, but one is that we've got the most clinical data in our delivery systems. All of our other vaccines are there, including our soon-to-be phase III program in CMV, our current phase III program, 1273, that you just asked about. As you know, for 1273, we've scaled manufacturing into commercial scales. Juan's presented on that in the past.
It just makes obvious sense to us from an RSV perspective to stick in that platform. It allows us to do combinations more easily and less complexity. Obviously, it's the most advanced. The 1172 RSV vaccine, the delivery vehicle, the Merck proprietary delivery vehicle, has really only ever been done in that one study, in that one phase I. It's just a dramatically different amount of experience and data between the two. That'll be our focus going forward on our proprietary LNP. Thanks. Stéphane [crosstalk].
Thanks for keeping my stuff. Oh, yeah. Sorry.
No, go ahead.
Sorry. Yeah. Gena, you're right. As we've said in the past, the entire vaccine portfolio, but the COVID vaccine is lyophilized. As we described in the past, for 1273, we decided to go liquid, knowing the impact on temperature, for two reasons. One is to increase the yield and the output we could get out of manufacturing, because, of course, every time you add a step in manufacturing processes, you lose yield. No process has a 100% yield. As we were already trying to preserve mass to make more vaccine to help more people, adding lyophilization seems like not a good idea when the goal was to make as many as we could. The second piece was, reliable capacity in the world is very constrained. It is expensive capacity.
When you think about the volume for a pandemic, there was not 1 billion dose equivalent of lyo capacity sitting idle and waiting for a pandemic to occur. On this practical side of us to say now lyo is going to be so hard to find the capacity. This is why 1273 went liquid. Now let's talk to the DARPA and the DARPA NOW project. The whole idea here is to be decentralized, close to a point of use of a medicine. The challenge that you have in traditional commercial product to make a product that could be used on the other side of the world in one year or two years, where stability is critical, is a totally different ballgame.
We have not finalized with DARPA all the spec of a project, but again, I think I'm going to use the Nespresso machine as a kind of humoristic way to describe the box is going to be, of course, a bit bigger as we describe the size target of DARPA. I think the whole idea is to have a self-contained unit, a factory in a box, where literally when the products comes out, they are used within hours or days.
If you go back to what we've said around our storage capacity, for 1273, we said that in a 2-5 degrees Celsius typical fridge temperature, like you store insulin or other medicines sometime at home for patients, you could store that for at least seven days, and most probably longer if you do not have the -20 in between. Nothing has been finalized, is the punchline. Given the intent of use of that manufacturing device, I think liquid will be a great solution.
Thank you.
Thanks, Gena.
Thank you. Our next question comes from Cory Kasimov with JPMorgan. Your line is now open.
Hey, guys, this is Matthew on for Cory. I appreciate all the added color from previous questions, but I'm still trying to reconcile why one of the largest vaccine companies in the world would instead just focus solely on an antibody approach in RSV. Just to be clear, did the decision have anything to do with the clinical profiles of either mRNA-1777 or mRNA-1172? Separately, can you comment on what you and Merck have seen in RSV in terms of the durability of antibody responses? Thank you.
Thanks, Matt, for the question. Again, I can't speak for Merck's own determination here on the RSV program, so you'd have to refer your questions to them. I can say that from our side, there's nothing we've seen in 1777 or 1172 or that we hope to see in 1345 that's going to dissuade us from moving forward. In terms of durability of antibody response, again, I don't think we've published all the data on that yet, but I would point to our CMV data or any place where we have shown durability that has been quite significant, for instance, in the CMV vaccine. We have no reason to expect it to be dramatically different here. Again, we'll subject to when we have those interim analyses and studies completed, and we'll share those data.
I do think competitive dynamics are something that would weigh on me if I was making the decision, Matt. As an example, Merck has a phase II antibody program, and this would be a phase I RSV program. As a monovaccine, in the best of situations, would not be terribly differentiated from the soon-to-be phase III programs from a couple of the other largest vaccines manufacturers. I think it's not an unreasonable strategic determination to just say, "Look, RSV is a pretty competitive space in the vaccine space, and a monotherapy vaccine may not be a late entrant monotherapy vaccine may not be as competitive as you might hope, and therefore focus on the therapeutic sort of passive immune approach that's further along in your pipeline." Now that's conjecture on my side. I really can't speak for how Merck made their determination.
As we look to make our determination, we're certainly going to consider that competitive dynamic, that there are monotherapy RSV vaccines that are soon to be in phase III, that are substantially ahead, and that if you're going to bring forward an RSV vaccine, it either has to be dramatically better in RSV, or it has to be good in RSV and also have other benefits, for instance, combination with other viruses, to avoid the need for multiple injections. That's how we're thinking about it. That's how I would imagine that Merck might have thought about it. Again, you'd have to ask them directly for anything more.
Maybe just to add to Stephen, Matt. We should not forget that in the combination space, we own the rights to flu, we own the rights to COVID. As we've said in the past, vaccine is a strategic modality for Moderna. We want to invest and own assets on a global basis, and so those rights are not open for partnership. I think the competitive landscape and the combination field I think is really important.
Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is now open.
Hey, guys. Thanks for the question. Just had a couple on RSV. One of the bigger markets is in newborns and pediatrics, I guess, but more on the treatment side versus vaccines. I know your initial focus is in adults, but just want to get your thoughts on the opportunity in very young patients and what the challenges are from a regulatory perspective. Second question, just on your COVID patents, just curious about the path for retrospectively litigating the patent estate after the pandemic subsides. There's obviously going to be a lot more interest in leveraging some components of your technology, of the RNA-LNP technology. Obviously you want to protect that. Thank you.
Yeah. Thanks for those questions.
Geoff.
Oh, go ahead, Stephen.
I was going to take the first question on the regulatory path and pediatrics, because we do have a program in RSV pedes. In fact, we had kept the rights for that all along, believing that that's a high unmet need. Just like we have a combination already launched for the two pediatric respiratory viruses or viruses that have a high unmet need in peds, HMPV and PIV3, we are moving ahead also with RSV in pediatrics.
Regarding the regulatory path, I think we had disclosed in the past, we've had initial conversations with FDA on how one could combine the development of vaccines for pediatrics against different pathogens that are clinically indistinguishable, as is the case of these respiratory pathogens. I think there is a path forward that will allow us to develop these for a high unmet need in a way that is ultimately efficient for development. Let me stop there and pass it to Stephen.
Yeah. The only thing I'd add to that is we actually think RSV in pediatrics, this is why we declared a development candidate back in the beginning of this year. We actually think it's a significant opportunity, and to some of the prior questions, it's one where the competitive landscape, we think, is more wide open. The programs that others are pursuing are still in the middle stages of development, and they have really been limited to the viral vector approached vaccines for those pediatric populations because of the concern about safety, about recombinant proteins and adjuvants in pediatrics. It's a natural place for mRNA, we think by itself, but we think it's a place where we really will differentiate as we do combinations in the pediatric space. There, we're actually quite bullish for that half of the unmet need as you look at it epidemiologically.
What's new today is we're also going to be considering combinations in the elderly. On the COVID-19 patent question, and specifically, I think you said retrospective litigation, so after the pandemic, going out after people, that would be inconsistent with the value statement we're trying to make today. What we're trying to say today as clearly as we can is we will not enforce these patents for any activity undertaken under the pandemic. The reason is simple. We do think we've made great inventions. We think the history over the last 10 years of the company, over the last five years as we've done vaccines in humans, is significant. We've described those inventions to the world, we've shown what's possible, and we've been issued composition and matter patents that cover key aspects of this.
That, under any normal circumstances, you might say is something that would disincentivize others from bringing forward vaccines. What we wanted to be clear about today is that we have no interest in that disincentive. We do not want to stop vaccines being brought forward during the pandemic. It's a decision we'd taken previously, but not disclosed publicly. As time passed here, we feel an obligation to now disclose it publicly because there are good, well-intentioned questions about IP, the use of IP as vaccines come closer to market, what that would mean, where rights are. It will not be our intention retrospectively to kind of come back around and say, "No, now we're going to enforce for activity that happened in the pandemic." That is not what we're saying. We will not enforce for activity to bring forward vaccines during the pandemic. Full stop.
Okay. Thanks, guys.
Thank you. Our next question comes from Hartaj Singh with Oppenheimer & Co. Your line is now open.
Great. Thanks for the questions and all of the work. Just a couple of quick questions on mRNA-1273. One is, you might have answered this partially earlier, just want to be sure. Any recent updates to the FDA guidance? Does that shift I think the two months fall off safety, et cetera? Does that shift the potential timing for when an AdCom could happen for an EUA? It seems the agency is going to do it on an individual basis going forward. Next year, it looks like you should be a company with quite a lot of sales and breakeven. Are you thinking about guidance, I know it's very early, how are you thinking about how to frame that for investors going forward? Thank you for the question.
Hi, Hartaj. It's Tal. Let me take the first question. I don't think there's a shift in the FDA guidance. I think that the two months for us will be crossed on November 24th. I think the first interim will happen sometime in November. If it happens sooner, and the DSMB tells us that we've crossed it, then we'll let the world know, and we'll let FDA know, and we'll start the prep work. It'll take, obviously, some time between knowing that we've crossed it and actually running all the analysis and getting ready for that EUA. That will probably take, my initial estimate is around 10- 14 days likely in between. Along that, if it hadn't happened already, we probably will have crossed the two months interim.
If it happens all earlier and we're sitting there mid-November and we're a week shy of that date, I still think FDA would like to see the totality of the data, and I'm sure it'll be a discussion point for VRBPAC. Again, I think we all understand this as a clear guidance. I think the stars are aligning one way or another for that first interim to happen in November. I'll pass it over to Stéphane for your second question.
Yeah. This is David Meline. On the guidance question, what I would say is a couple things. One is that we haven't made a final determination yet as to when we might do that. I think to the extent that guidance can be helpful to investors to understand how we're viewing the business evolving, we certainly are quite happy to do that. We'll have to just see how this evolves. We'll have the Q3 call coming up at the end of the month. I think right now there's so much uncertainty, it's unlikely we'd be providing broad guidance there, but we'll give some specific indicators as we did last call of information that we know that we think will be useful to investors. As we go to the report out of the full-year results, I think the chances increase that there will be visibility looking into 2021.
Yeah.
Great. Thank you.
This is Stéphane. Just to maybe add a little bit to David's comments. I think everybody realize that this is a very, very unusual time. I've never launched a product during a pandemic for obvious reasons. As you've seen so far, those are big contracts and big orders where until it is signed, it is not signed. Price has a big impact on value when you multiply it by 10s or 50s or 100s million of doses. To precisely guide, I think it's going to be challenging, as David said.
We're going to do like we have done so far, and as David said on the call, and also the 8-K we filed after the U.S. government partnership. We're going to try to give you as much granularity of what we know so that indeed, analysts and also, of course, investors can have a sense of where we're heading in terms of sales and P&L.
Great. Thank you. Thank you all.
Thank you. Our next question comes from Mani Foroohar with SVB Leerink . Your line is now open.
Hey, guys. Thanks for taking my call and the question. A quick follow-up. I may have cut out for a moment there while Tal was talking about the interim communication plan. If the interim passes with neither a stop for efficacy or for [futility], but the study continues based on the statistical plan, I presume you would not disclose that because you want to preserve the integrity of the trial, or would we expect that you would disclose whether or not the interim has passed?
A question on the relationship with DARPA. Obviously, a fascinating technology. Could be really relevant, especially for places that lack more robust development, et cetera, lower income countries. Africa was mentioned earlier. Can you give us a sense of where that technology is in development? Still in discovery stage or sort of how far along are we to that more mobile manufacturing technology being closer to application?
This is Tal. Thank you for that. Let me take the first question. We, in the interest of transparency, we do intend to disclose when the DSMB has reviewed the first 53 cases after the first interim analysis and have rendered an opinion and what that opinion is. There's a high likelihood that we won't cross it. The trial is designed for a reason to go to 151 cases. There is a likelihood that we will cross it. It is up to the efficacy of the vaccine and an element of luck here. I think that in the current era, with all the attention, we have decided to be as transparent as is possible, short of, as you say, harming the integrity of the trial.
I do not, I pray that the fact that people know the results, people will be wise enough to understand that the fact that we crossed it simply means that we did not yet cross it. It will not mean that the vaccine is ineffective. It will simply mean that we do not yet know its effectiveness or whether it's effective. With that in mind, I think our current plan is to disclose the DSMB opinion one way or the other.
It's Stéphane for the DARPA question. For those of you that have visited Norwood you have seen. The personalized cancer vaccine unit where we make individualized dose for the personalized cancer vaccine program. That kind of give you already a sense of where we are in the ability to manufacturing kind of single dose at a time. For those of you that, again, that have seen it's more than 6 ft by 6 ft by 6 ft.
I think the work ahead of us is around how do you make it fit in that space through microfluidics, through process improvements, through a lot of other technologies. We're not starting from zero. We're starting from the ability to do that. I also remind you that we use that capability to do the phase I of mRNA-1273, because of a low dose versus a cancer vaccine, which I remind you, we do that 1 mg.
The fact that we don't make one dose for cancer patients. They get a shot every three weeks on the same schedule as KEYTRUDA. When you do the math, you actually realize that that manufacturing capability is plenty in one run for a phase I for infectious disease vaccine. We're starting from a very interesting base, which I think this is why DARPA was excited to partner with us again, is with that capability, they saw that we've already made a lot of progress. We have a good line of sight. There's still work ahead of us, which is why our grant is up to $56 million. There's going to be some engineering work. We have a very interesting starting place, to give us I believe a high likelihood to make it happen.
Great. That's really helpful. Thanks for taking the questions.
Thank you. I'm showing no further questions in the queue at this time. I'd like to turn the call back to CEO, Stéphane Bancel, for any closing remarks.
Well, thank you, everybody, for jumping on the call quickly with us. I hope being available to answer those questions was helpful. I wish everybody to stay healthy and a great day. Speak soon. Bye.
Ladies and gentlemen, thank you for your participation on today's conference. This does conclude your program, and you may now disconnect.