Sep 14, 2020 / 01:45PM GMT
Matthew Kelsey Harrison - Morgan Stanley, Research Division - Executive Director
Good morning, everybody. I'm Matthew Harrison, one of the biotech analyst here at Morgan Stanley. Pleased to have Moderna up next with their CEO, Stéphane Bancel. Just before we get started, I need to read a disclosure statement, and then we'll jump into Q&A. Please note that this webcast is for Morgan Stanley's clients and appropriate Morgan Stanley employees only. This webcast is not for members of the press. If you are a member of the press, please disconnect and reach out separately. For important disclosures, please see the Morgan Stanley research disclosure website at morganstanley.com/researchdisclosures. And if you have any questions, please reach out to your Morgan Stanley representative.
Questions and Answers:
Matthew Kelsey Harrison - Morgan Stanley, Research Division - Executive DirectorSo great. So Stéphane, thanks for being here with us this morning. I thought maybe to start out, we'll go right into the COVID vaccine questions. You're obviously well into your Phase III study at this point. Maybe give people an update on how you're thinking about time lines related to that data.
Stéphane Bancel - Moderna, Inc. - CEO & Director
Great. Well, good morning, Matthew, and good morning, everybody. Thank you for having us. So on the study indeed as of Friday, as you know, we announced updates every Friday, we were at 23,497 participants that have been enrolled. As you can do the math, from the start of the study, July 27, we now have already a significant number of people that have got their boost. And to remind everybody, this is like the over vaccine participant, an event-driven trial. And so we need to look at the number of cases. As we've said publicly, the first interim data is 53 cases. And so as we've said all along, we anticipate the base plan for readout in November.
There's a high-case scenario of earliest in October. People have asked September, September is not in the cards. The math does not work for September. But the base plan still is November, given the epidemiology and the attack rate, which we follow daily and we will forecast daily the cases and so on internally. We stick to our time lines, November base case. A best-case scenario of October. If epidemiology was to really slow down drastically, you could see this moving out into December. But I think November still is a very reasonable assumption.
Matthew Kelsey Harrison - Morgan Stanley, Research Division - Executive Director
Okay. Perfect. And related to enrollment, Pfizer, over the weekend, talked about increasing enrollment to, I think, 44,000. I think it was the week before, you talked about slowing enrollment a little bit to have a more diverse population. Would you consider expanding your study? And I guess relative to Pfizer, do you feel like you're falling behind if you don't expand your study?
Stéphane Bancel - Moderna, Inc. - CEO & Director
So it's an interesting question, and we are still kind of thinking about it. As you said, we decided 2 weeks ago or 4 weeks ago, I forgot now, to slow down the study enrollment to ensure we have strong diversity. We have 27% of diversity across the different groups as of last Friday. We think it's very important for the public perception and people in different groups feeling that they have a good understanding of safety and efficacy in their population over vaccine. We don't think that's slowing down on the end of the study, impacts readout because again, the readouts will be driven by people that were firstly enrolled in the study. And so we thought it was the right trade, both to manage the quality of the study to ensure uptake once the product is potentially approved, but without compromising on time to read out.
On the decision do we increase or not, we are always talking about it. This is not prompted by the Pfizer, it's just on self-aware. We've had that discussion a few times. The picture was want to be careful is -- as you do it is does it make sense for your study, given that we already, for example, have HIV patients in our case that are enrolled in the study as it is. And then still, people get 50% placebo. And so are you better off depending on the time of a readout to just keep it as it is so that people can have access in a high-risk group of vaccine, for sure, not a placebo 50% chance. So we're still wrestling with it and thinking about it a lot. So if there is an update, we will provide it. But as of today, the plan is to stick to the 30,000 participant Phase III study.
Matthew Kelsey Harrison - Morgan Stanley, Research Division - Executive Director
And how you're thinking about children because they obviously, I think, lowered the age to 16, I believe, in that expansion. So how are you guys thinking about the pediatric population?
Stéphane Bancel - Moderna, Inc. - CEO & Director
Yes. So like every vaccine manufacturers, when you go into a Phase III, you have to kind of commit to FDA that you will do pediatric, which, of course, we did. It is our intent to go into the pediatric setting. We want to go at it holistically, we think a year or 2, again going back from 18 to 16 is nice and important. But we want to do pediatric holistically. We want to go down in age. And I think if you look at the vaccine world, there's most probably going to be 9 to 17, which is what other people do given the risk profile. And then you kind of age -- escalate by age group, and potentially, dose might have to be different in the smaller children. And so we will share our plans there when they are finalized with the agency. But we do want to go down into the pediatric, down to pretty low age for people on the call that are not aware for hMPV/PIV vaccine, we have already gone down to the pediatric setting. So this is not news for Moderna, like other mRNA vaccine companies that are not on pediatric yet. We have already done it with the same lipid system, same chemistry, same manufacturing process as what is in 1273. So I don't see any reason why we should not, at the right time in terms of safety, go into the pediatric.
As you know, Matt, the FDA wants to see enough of the database to go down into pediatric for safety or Phase III. So we're getting pretty close to it now given the size we have and the repeat dose we have for the people who got the boost. So I think it's a matter of just a very short amount of time before we can share in detail our plans there.
Matthew Kelsey Harrison - Morgan Stanley, Research Division - Executive Director
Okay, great. And then older patients, you obviously, a couple of weeks ago, at the ACIP meeting, put out the titer levels in older adults. How are you thinking about relative efficacy and clinical efficacy, I mean here, for the older adults compared to maybe the younger, healthier population, and do you think that similar titers could lead to better overall efficacy because you think you're going to see the same thing in older adults?
Stéphane Bancel - Moderna, Inc. - CEO & Director
Yes. So that's a great question. So again, for people that are not familiar with the data, which should be published very soon now, the full data set, but people can find the ACIP data on our website. We are very pleased to show -- like we have shown in our vaccine. Again, this is not news to Moderna mRNA vaccine is that neutralizing antibody level is a similar level between young adults and the elderly, both the 56 to 70 age group and the 71 and above. We are very pleased by it, Matt, as you can appreciate, given the high risk in the elderly population. We believe this will translate in terms of efficacy in the Phase III. Of course, we have to show it with the data but our scientific understanding is that this will translate. We think that will differentiate our products potentially materially. As you know, other groups that have reported elderly have seen a material decrease of neutralizing antibody to the young adults. And of course, antibody wins over time, as we all know. And so we believe that benefit in the elderly that the Moderna vaccine has shown will improve and translate into material efficacy in the Phase III, again, to be demonstrated in the weeks to come.
Matthew Kelsey Harrison - Morgan Stanley, Research Division - Executive Director
Okay. Perfect. Can we talk safety a little bit? Obviously, Astra was in the news last week with a pause on a safety event, which is -- I guess how do you think about the risk of an event like that in your study? And what sort of measures are in place to manage those risks?
Stéphane Bancel - Moderna, Inc. - CEO & Director
Yes. So what is really important is safety, it is the number one priority for anybody developing a vaccine because, of course, they are given to healthy people. And so as you know, global industry for a long time has been very developed with the help and coordination with the FDA to monitor safety very precisely. Even the reporting of safety event is a different scale from, let's say, an oncology study to a vaccine study, which sometimes people are surprised about. When they are specialists in oncology, they look at the side effects and they are very surprised to see the difference. And again, they are adapted that you want to pick any signal. It's really very important.
So every vaccine that is in development is always be aware -- are aware to be put on hold as happened to the AstraZeneca program last week. I think it should give everybody comfort that the industry and the regulators are very focused on safety and that if or when there is any signal, the right thing to do and the first thing to do is to put everything on hold. Everybody has an outside independent Safety Advisory Board that reviews all the data. And so we're actually the one making the decision, not the company determination. Of course, a lot of time, when it's kind of not very clear, they inform the company, there is a dialogue. But at the end of the day, if a safety committee deems that the study should be paused, it will be paused.
And so what happened last week, I would say, is -- happens frequently in vaccine development. It could happen to us, it could happen to any other vaccine that is in the clinic. It is very hard from a distance, given we have not seen any of the data to know if it is an isolated event. That was not corrected to the vaccine. There we opened the study on Saturday, so we just paused for a few days. So I will conclude from that, that the scientific committee did not find an obvious kind of root cause to the vaccine. I know people have speculated last week is it potentially something linked to the adeno technology, nobody knows given the fact. Again, we don't have the raw data. And also, people went as far as questioning, is it a risk with the Spike S protein. I mean if you look at the data today, if you look across all the vaccines that are targeting the Spike S, we I think by my backlog and road map at north of 70,000 people that have got injected and being participated in those studies. I think there was a safety issue with the Spike S at 70,000, we would have already seen it. Again, it doesn't mean it's not there. Again, it is possible to have a very, very rare event. But at this stage, I think what happened last week, I think, for me, is good news in terms of the vaccine manufacturing to be very careful, and the regulators wanting to make sure that we don't confuse getting a vaccine out as fast as we can, but without cutting corner. Cutting corner is not an option.
Matthew Kelsey Harrison - Morgan Stanley, Research Division - Executive Director
And have you gone back and looked at your Phase I or your Phase II safety database or safety data base broadly for -- and taking a closer look at any neurological side effects to see if something like this could have been missed? Or have the regulators reached out and asked for you to do that?
Stéphane Bancel - Moderna, Inc. - CEO & Director
So we always do that. It's a very typical practice in the industry. And I would not be surprised if everybody else who is developing a vaccine in the clinic being Phase I, Phase II or Phase III. Once the news came out of AZ, it didn't have a safety committee go back. And this was again safety committee are trained to do. So there's nothing to report from us. But again, we will take safety as the highest importance in those studies. And any signal you have from your vaccine over vaccines prompts you to -- so we look at the entirety of the data.
Matthew Kelsey Harrison - Morgan Stanley, Research Division - Executive Director
And then one final question and then we'll move on. I guess has the regulator -- because there hasn't been an mRNA vaccine approved previously. Has the regulator asked for any special monitoring or special things related to mRNA and the technology broadly that you've been watching for from a safety side effect standpoint?
Stéphane Bancel - Moderna, Inc. - CEO & Director
Yes. So I cannot comment on the field of mRNA because, as you know, Matt, the vaccines are very different. Some companies, it's the first time they are taking a vaccine to the clinic. Some -- I mean more than 8 to 10 vaccines were taken to the clinic. So in our case, there is no special request by the FDA that will be linked to a new technology. As you know, those are very big studies, 30,000 participants is a big study, much bigger than typical vaccine studies or Phase III for approval. And so we are monitoring everything closely, but we should not forget that the mRNA molecule is with 6, 8 hours half-life, it's gone after 48 hours. With our technology [evolution], it doesn't get into (inaudible). So there's no risk that we understand technically of reintegration into human DNA. And the lipid has a couple of half-life as well. So there's no real reason for us to have long-term safety who always linked to mRNA technology. But again, we don't know what we don't know, it's injected to healthy people. So we are extremely careful and monitoring our team.
Matthew Kelsey Harrison - Morgan Stanley, Research Division - Executive Director
Perfect. Phase II, you finished enrolling July 8, I think. Would we expect that data shortly? And then, I guess, what do we get out of that data that's different than what you've already disclosed from the various Phase I studies?
Stéphane Bancel - Moderna, Inc. - CEO & Director
Yes. So it's a good question. So the Phase I had no placebo, where NIH decided to do the Phase I with no placebo, where Phase II has a placebo and the 50 and the 100-microgram dose, I remind people the Phase III dose is 100 microgram. So I think what you will see is that, first, you're going to see a placebo arm, which I think, again, to investors that are not used to look at vaccine data, you will see actually that when you put head to head, like we've done with all of our vaccine in the (inaudible) side effects, you actually realize that the side effect linked to the vaccine is much lower when you put it in contrast to the placebo, because you realize that people that get a placebo have pain in their arm because we just put a needle in their arm and you put a volume of water in there. And that even some people on placebo reported headaches, over side effects that actually not attributed to the vaccine. So I think that's going to be an interesting data set.
The other piece is the size. But as you know, this is not an event-driven efficacy study. It's a Phase II that was mostly done to be comfortable for us and for regulators around safety. So 600 people in our Phase I, young adult was 45 people. So it's a difficult kind of stepping stone into a Phase III where you're going to thousands of people participating to the studies. So I think for, again, people who don't know the technology well, they will have confirmation in the bigger data set of what we saw in the Phase I. In our Phase I, we saw all participants, I mean, 100% of participant. I mean neutralizing antibodies at or above (inaudible), I think you see the same thing. I think what is really nice about mRNA technology, we have a very strong control process like we have at Moderna is the fact that we have very tight patient to patient variability between the lowest and the highest participant neutralizing antibody. We've shown it in CMV, we've shown it in our (inaudible), we've shown it across the platform of Moderna. And I think it is true of our mRNA platforms because of the lipid they use, because of the manufacturing process they use. And so I think people will be happy to see that we have seen that we have a vaccine. But as you go to a bigger end, you have the same outcome in terms of -- you have high neutralizing antibody to the vast majority, if not all the participants. So it's just a confirmation study in my opinion.
Matthew Kelsey Harrison - Morgan Stanley, Research Division - Executive Director
Okay. Okay. Can we talk about regulatory standard? There's been a lot of debate in the press, et cetera, about what's happening. I mean, what's your thought on what the standard is going to be for an EUA versus a BLA? And it sounds like we should expect some sort of EUA processes as the initial process. So I don't know if you agree with that or not.
Stéphane Bancel - Moderna, Inc. - CEO & Director
Yes. So let me start at the BLA and then let work backward into a EUA. So as you know, the FDA has set a very clear guidelines, I think it was in June, around the 50% minimum efficacy expected and around the 30,000 participants kind of minimum study side expected, which, for us, industry was very useful to know there was very clear guidelines that we could adhere to and know where the goal post was. So that's for the BLA.
If you look at the EUA, so first, it's important for people to know that there has not been EUA for vaccines before. So this is a part of legislation that exists for EUA that has been used on the therapeutic side a number of times but that's not been used in vaccines. Dr. Marks, who run CBER, has commented last week that it would be more of an EUA plus in terms of standards. And our understanding of that comment is that they do not intend to lower the bar on efficacy for the EUA. So what we expect is sponsors will have to show an efficacy of at least 50% to be able to get an EUA. An EUA will not be accepted if it was based on neutralizing antibodies because, as we all know, there is none yet given it's such a new virus, that correlates of protection. And the agency has been very, very clear about it in public meetings and comments and guidelines as well as in private discussions.
So what we've understand the EUA plus being is it's an EUA in a sense that you might get very quick approval for emergency use in a smaller population. Our understanding is you will be -- it could be -- sorry, I want to be careful because I'm not FDA, it could be health care worker and it could be the elderly. What is not clear is where will be the age cutoff. Is it going to be 75, 70, 65? And by this mechanism, we will give the FDA I think a very nice position of the risk/reward, where you give access to a vaccine that you believe has a 50% efficacy, that's the EUA plus. And you don't give access to all the U.S. population, so you can still continue to monitor safety. Because if you think about the time line, I mean, we've said November, there's another (inaudible) company that has said October repeatedly.
With both studies having started on July 27, that's not a lot of months of safety data set. And so what we understand is that the EUA or EUA plus would be 50% efficacy will be whatever safety is available at that time. And by adding a small population that is manageable at very high risk, it gives FDA the possibility to give access to a much-needed product and to monitor very tightly that small population before I would assume a few months after, when there is enough or a bit more safety launches in our data across the study, across people that have access on the EUA to then get a full BLA.
Matthew Kelsey Harrison - Morgan Stanley, Research Division - Executive Director
Okay. Perfect. I want to make sure we have time for some non-COVID topics, but I guess 2 more things on COVID that come up a lot. Manufacturing, maybe just give us an update there. How many doses have you produced so far? And where do you think you'll be by the end of the year? And I guess the last part to that is what gets you from that 500 million run rate to the 1 billion run rate?
Stéphane Bancel - Moderna, Inc. - CEO & Director
Yes. So let me start by the big picture and then I'll go into the detail. So we confirm that our base plan, we know how to make 500 million doses next year. The team is very comfortable that they have a good line of sight to that. What the team is working very hard is how do we get to 1 billion dose, and they are making very good progress. If you think about the 4 bottlenecks that exist to get to that outcome is you need GMP space and (inaudible). We have enough GMP space for 1 billion doses. That's not an issue. You need capital equipment to make the product and this between what we have already received and validated and what is literally in flight coming soon and with recent confirmation by suppliers that they are on time and on track to deliver that, we think on the CapEx front, we will have manufacturing capacity to deliver 1 billion dose.
Then you have 2 more things left that you need to achieve to get to the finish line. One is people, we are very advanced in the recruitment of people. We've had incredible quality and numbers of people that have sent us resumes to apply for jobs. So we feel very good about our ability to get enough people to deliver 1 billion dose. The last piece is raw materials. So as I said, we have a good line of sight to 500 million doses. What is not clear yet today is will we get on time all the raw material to get to 1 billion dose. So as, of course, time is going to go by, we're going to get more and more certainty about getting or not getting and what quantity we're going to get. So I think what we should anticipate, Matthew, is as time goes by in the next few months, we'll update that number. I expect it to be updated on the way up. It's very hard to say, are we going to get to 800 million doses or 900 million or 1 billion for fiscal year '21, but the team is doing a very nice job and I'm cautiously optimistic that we will be north of 500 million. But 500 million, I think is a lot of people can use and put in the back income of what we can deliver.
In 2020, we have not communicated publicly a precise number because the ramp is like this, and the team are still doing a lot of work, but it's going to be in the millions of doses, it's not going to be 50 million doses, it's going to be neither 500,000 doses, it's going to be many millions of doses. And the team is working really hard to push that number as much as we can. Again, as always, it's a bit like on the clinical front, which studies you don't want to cut corners, where it's the same thing as you do manufacturing. Quality is critical. We do not want to cut corners. We have to make sure we ship high-quality products that meet the highest spec of quality, and of course, FDA standards.
Matthew Kelsey Harrison - Morgan Stanley, Research Division - Executive Director
And then distribution, you've obviously commented on your cold chain requirements. Can you just put that in context with what exists from the distribution network out there and how you're thinking about distribution?
Stéphane Bancel - Moderna, Inc. - CEO & Director
Yes. So lack of mRNA vaccine that have to be still at minus 17, we are at minus 20. And the reason we did that technology change, which required a lot of investment around many years is that the distribution channels do have minus 20 capabilities. If you look to all the big distributors and whole sellers in the developed world and even in the developing world, they are minus 23, those are available. And so that is why we made the move. If you look at the Moderna portfolio, all the other vaccines are (inaudible) at 2 to 5 Celsius storage condition. The reason we decided early on, and I'm sure it is the same reason over mRNA manufacturer first go liquid and not lyo is to maximize output. Lyo will have a 2 problem with the pandemic is one, you have a mass loss when you lyophilize a product because no process is 100% yield, of course. And given that we knew the industry was going to be with a supply constraint in the first 12 to 18 months post-launch, I think we all decided independently that to maximize the number of vials we could make, we could not go lyo because we will lose too much mass of vaccine as you do the manufacturing process.
And the second reason is there is not 1 billion dose or 2 billion or 5 billion dose of lyo capacity sitting idle in the world because lyo is very expensive. And so there was just a very practical access to supply. While we were confident we could file, especially we have a 10 dose per vial, so if we make 500 million dose, we only need to fill 50 million vials. And so it was clear to us based on mapping of the industry that we had that we had a good line of sight on how to get that. And as you know, we've signed deals with Catalent and with ROVI, so we know how to make that happen for filing. Lyo will have been a big issue. But thanks to the investment in science we made over years, we are able to deliver that at minus 20, which is a temperature that already has commercial product and freezer available into warehouses and distributors. That's not an issue. The other thing about distribution, which I think will be a big benefit to the Moderna product, Matthew, is the fact that we do not require on-site dilution. Some of our products require dilution on-site that increase the risk of quality because people make a mistake diluting. And it also makes it more complicated because it -- you cannot do that in any setting in a special kind of quality control setting in terms of nurse or doctors to do that and we don't need that. In the Moderna product, you literally get the vial out of a 2 to 5 C fridge because the last days can be at 2 to 5.
So you get it out of fridge, you put a syringe in a vial, you pull up one dose. You clean the arm, you inject it, you put band aid on. We don't need any device like some of our vaccine need. We don't need any dilution on-site. It's very straight forward. It's liquid. You don't need to reconstitute like lyo or whatever, so we think and we spend a lot of time with the team as we are designing the product, making all those decisions. So it could be really used for pandemic setting.
Matthew Kelsey Harrison - Morgan Stanley, Research Division - Executive Director
Okay, perfect. I guess last quickly, stability, how do you think about the need for -- how much stability you need for an EUA versus the BLA?
Stéphane Bancel - Moderna, Inc. - CEO & Director
So it will be initially in months and not in years because you won't have real-time data in years. And what will happen, which is very typical to some products that got accelerated into development, like sometime oncology products, is in the EUA label, you'll get whatever you have, and it might be 3 months, 4 months, 5 months. And then you will expand that label as you can show the data to the regulators. Again, very typical to our products. I don't think there's going to be any issue because the world is so waiting for vaccines that we're going to be hand to mouth from manufacturers to hospitals for a long time. So if we as an industry launch with 3- or 4-month or 5-month stability data, it is not an issue. It is, in my opinion, fantastic.
Matthew Kelsey Harrison - Morgan Stanley, Research Division - Executive Director
Okay. Perfect. So maybe in the last 6 or 7 minutes here, we can touch on some non-COVID topics. So CMV data, I guess, still on track for 3Q for that data. And then maybe because everybody has been so focused on COVID, remind us what we're going to get and what that means relative to your Phase III trial in CMV?
Stéphane Bancel - Moderna, Inc. - CEO & Director
Great. Well, thank you for asking a non-COVID question because I get all these days. So indeed, we have a very big portfolio at Moderna with 23 development candidates. The next big one in the vaccine world is CMV, cytomegalovirus. That is a virus that is the #1 cause of birth defect in the U.S. and around the developed world. 10,000 kids in the U.S. just this year will be born with birth defect or will die. No vaccine on the market. The industry has been for 20 years trying to make a vaccine. And what the industry could not do is do the right antigen. The Moderna vaccine has 6 different mRNA in the trial and we saw very exciting Phase I data.
The Phase II data indeed is confirmed for Q3. And given we are September 14, it means it's going to come up very quickly, I'll confirm the Q3 date. And what you're going to see is going to see a much bigger data set in terms of the number of participants in the study neutralizing antibodies on gB antigen and pathogen antigen that showed for our Phase 1 of our safety. The dose range, as you remember, Matthew, is tighter than what it was in the Phase I. Again, we had never done the 6 mRNA product in the clinic before, so we wanted a big range because we don't understand really much how much antigen were going to get expressed in the safety profile. Based on that exciting but early Phase I data, we basically narrowed the dose for the Phase II. So I think what we want to get is a bigger end and also a sense for what will be the dose for our Phase III. The phase III is totally on track to start in 2021. We have already a Type C meeting with the FDA on CMC. So the manufacturing questions we had have all been answered by the FDA, which is great for CMB, but of course, was very helpful also for the COVID vaccine 1273. And so what we need once sort of the data is cleaned up and finalized is an end of Phase II meeting with the agency to finalize the Phase III. We already had a question with the FDA around endpoint as we shared before, size of Phase III and so on. So we think it's more of kind of -- we group with the agency and hold hand before we start the Phase III. But in our opinion, everything is nicely on track to start the CMV Phase III in 2021.
Matthew Kelsey Harrison - Morgan Stanley, Research Division - Executive Director
Okay. Good. And I guess remind people market opportunity for CMV and competitive risk there?
Stéphane Bancel - Moderna, Inc. - CEO & Director
Yes. So CMV, we believe, is a $2 billion to $5 billion annual peak sales product. We believe the first indication will be in adults, and the target product profile is going to be women in the age of bearing a child before pregnancy. So we see that as being a GP and OBGYN product that a woman will get vaccinated when she does a regular visit to the GP or OBGYN, depending on habit. It is not intended for pregnant women and then what we want to do is to run a study in the teenager setting because we believe it will be a great product to be vaccinated at the same time as the HPV GARDASIL vaccine is vaccinated into teenager. So literally you put (inaudible) in one arm, you get HPV on the other arm the same day. You get the CMV vaccine.
And then our goal is to go down in age because CMV is only transmitted by humans. And so like rubella, if we were to get into the newborn, we should be able to eradicate CMV, we should be fantastic public health victory. We talk about birth defects, there's a subliminal data being reported at CMV as a long-term impact on somebody's quality of life. Once infected by CMV, you are infected for life, a bit like, in fact, it is HPV. And there is more and more data coming, there is no concession demonstrated yet. But more and more data coming that actually people that have CMV have a long time higher rate of cancers and other disease. So that's why we think if we could vaccinate everybody against CMV, women, men and then adolescent and then toddlers that will be a great thing for public health.
Matthew Kelsey Harrison - Morgan Stanley, Research Division - Executive Director
Okay. Perfect. And then maybe in the last couple of minutes, some of the rare disease programs, obviously, they have been impacted by COVID in terms of being able to enroll them. Just any updates on where patients are and your ability to generate data there and how you're thinking about when we might see something out of them?
Stéphane Bancel - Moderna, Inc. - CEO & Director
So Matthew, given this is not a broad public meeting, it's hard for me to give updates compared to what we shared at the quarterly call. In our quarterly call, we are saying that we were in the process of kind of restarting sites and reengaging sites across the board with children, hMPV/PIV in vaccine, so the rare disease. We have an R&D Day coming up on Thursday like every year, after the Morgan Stanley conference. And we will be very happy to give an update on the rare disease as well as the oncology program because we have 5 program in oncology in the clinic. So we'll give a full update on those 2 on Thursday to make sure that I don't by mistake bridge Reg FD today.
Matthew Kelsey Harrison - Morgan Stanley, Research Division - Executive Director
Okay. Okay. So maybe then last question, I think you extended your partnership with Vertex, obviously getting mRNA into the lung is an interesting problem. Maybe remind people when might you think you'll have something ready to put into the clinic there? And what's sort of the opportunity you're targeting?
Stéphane Bancel - Moderna, Inc. - CEO & Director
Yes. So thank you so much. So indeed, we are very pleased that Vertex twice decided to expand the collaboration to deliver mRNA via [IOSR] into the lung to express a full CFTR protein. The goal of Vertex, I think, is definitely to go after -- as it's well documented and talked about by the Vertex management, to go after those kids that do not respond to Vertex drugs because of genetic mutations. We've shared some exciting progress at our Science Day back in the spring. We have not forward guided with Vertex as to when we're going to the clinic with this program. But I think if the momentum continues and the teams are doing very good, we should, in the next 2 quarters, be able to declare a candidate, take the candidate into the clinic. And if that works, it will provide with Moderna the ability to get into the lung as a new modality, as a new space. And Vertex has only right to the CFTR gene. So everything else in cancer, in the pulmonary disease, in infectious disease, will be 100% owned to Moderna with no royalties back into Vertex. So we are very excited about that.
And as you know, we're also working, as we showed in our Science Day 2 years ago, on getting into the blood through mRNA to go potentially into immune disease and so on. So there's a lot of things cooking. And we are very excited about the company prospects. I think COVID is kind of the first product that has a chance to get approved and to show that mRNA can be, and you may have seen, if this happens, which would be very derisking to the entire platform because all of our products, we use the same chemistry. Of course, formulation varies by application, which is also why the COVID vaccine gets approved, I think it will be very powerful with across and increase the priority of success of all our vaccines.
Matthew Kelsey Harrison - Morgan Stanley, Research Division - Executive Director
Great. Stéphane, thanks for being here. Thanks for the thoughtful answers.
Stéphane Bancel - Moderna, Inc. - CEO & Director
Thank you, Matthew, for the invite and stay well. Speak to you soon, latest Thursday, I'm sure. Thanks. Bye-bye.
Matthew Kelsey Harrison - Morgan Stanley, Research Division - Executive Director
Bye.
Call participants:
Corporate ParticipantsStéphane Bancel, Moderna, Inc. - CEO & Director
Conference Call Participants
Matthew Kelsey Harrison, Morgan Stanley, Research Division - Executive Director
Refinitiv StreetEvents Transcript
Moderna Inc at Morgan Stanley Global Healthcare Conference (Virtual)
Sep 14, 2020 / 01:45PM GMT
