Moderna, Inc. (MRNA) Earnings Call Transcript & Summary

Hi. Good morning, everyone, and welcome to the second day of BMO's Growth and ESG Conference. My name is George Farmer. I'm senior biotechnology analyst in -- with BMO. And it is my pleasure today to have us -- have with us Lavina Talukdar, who's the Senior Vice President and Head of Investor Relations for Moderna. Moderna is an extremely exciting company, certainly very high-profile in the news lately on the forefront of coronavirus research. Moderna, as everyone knows, has one of the leading vaccine candidates in development. We saw some very exciting Phase III results from the company released not too long ago. But Moderna is certainly much more than just its coronavirus vaccine candidate, and we hope to dig into a little bit of that as well. But I do want to dedicate most of our time here to talking about the latest in the corona vaccine research space.

Along those lines, maybe we could start off, welcome, Lavina. Thank you for joining us. Maybe for the benefit of the audience, can you just give us kind of like a high level of Moderna's technology platform and how it's being applied to treating human disease?

Sure. Thank you, George, for having me and giving me the opportunity to speak with you today. So let's start off with, at a very high level, what the goal of every vaccine is. And the goal of every vaccine is to show the immune system an antigen or a foreign particle associated with the virus so that the immune system will then recognize it, should it see that virus at a future time point. And so all vaccines try and elicit that immune response. However, the approach and often the results that into are what make each of the vaccines differ. So for instance, traditional vaccines that make a protein in manufacturing plants that is associated with the virus is often used within a vaccine. mRNA vaccines also look at used proteins. However, the protein itself is made inside the cell of the person receiving the vaccine. And that is because we encode for the protein using an mRNA sequence and use that in our vaccine to then elicit an immune response. When the protein is made inside of the cell, it can conform to its most natural confirmation, which we believe allows for a very strong recognition of that protein for the immune system to then recognize it if and when a person is then exposed to the virus, which will then elicit a very strong immune response.

Great. And can you talk about how you deliver that, the actual sequence to cells? And I know Moderna has proprietary technology around lipid nanoparticles. What are lipid nanoparticles? And how should we think about that relative to other modalities for administering vaccines?

Sure. So you're correct, lipid nanoparticles is our mode of delivery of our mRNA sequences for vaccines as well as for our therapeutic modalities. However, the nanoparticles do differ depending on the application that we're using. And so what are lipid nanoparticles? It's important to know that lipid nanoparticles have been around for many, many years. The industry standards are out there, and many companies do use them. However, the industry standard lipid nanoparticles often pose a problem in terms of eliciting an immune response that you don't necessarily want when you're administering a vaccine or a therapeutic. As a result, the scientists at Moderna have worked and improved upon and innovated around the standard lipid nanoparticles that are -- that have been used in the industry for many, many years. And have -- we now have a proprietary IP-protected lipid nanoparticles that we use for our different applications. And so a lipid nanoparticle, you really can think of it as a fat molecule or a cholesterol molecule that's innate in many ways, and our lipid nanoparticles are innates because they are -- they don't elicit a very strong immune response, which is exactly what we aimed for.

And how do lipid nanoparticles avoid eliciting an immune response? I mean, they are generally foreign. So how should that be possible that we don't develop antibody responses or just general immune responses to these particles? Is there a -- some secret sauce there?

There is some secret sauce there and those are the innovations and improvements the scientists at Moderna have made and have patent protected.

Okay. Great. And so the company has been applying this technology to a variety of vaccines. Maybe we can just jump into 1273, which is the coronavirus vaccine that has been pretty high-profile in the news lately. Can you talk about the design of the vaccine? And what does the RNA component encode for? How is it manipulated in such a way to elicit a maximum immune response? And how does that compare to some of the other vaccines that are in development?

Sure. Good question. So we encode for the Spike S protein on the SARS-CoV-2 virus. And the reason why many others have chosen the Spike S protein is because it's an important protein that allows for entry into the host cell. So without it, the virus itself couldn't enter the cell and then replicate itself. So clearly, that's a protein you would like to neutralize, and that's the goal of many of the vaccines that are currently in clinical trials. What Moderna did once the Chinese government put the whole genome of the SARS-CoV-2 virus online, our scientists, along with scientists at the NIH, designed the 1273 vaccine, using techniques and some experience that they had during designing a MERS vaccine, another coronavirus vaccine. And what we -- what the -- what our vaccine encodes for is the Spike S protein, but it's in the prefusion stabilized form. And so the mRNA is encoding for the confirmation of the vaccine prior to the virus actually attaching to a host cell, which should make it much more recognizable to the immune system, and that's what's in our vaccine for 1273. Interesting enough, is that mRNA in all of our vaccines is the same mRNA that we use for vaccines for therapeutic. So there aren't many bells and whistles or differences between that. The lipid nanoparticle that's used in the 1273 vaccine is also used in many of our other vaccines that are in clinical trials currently. Some of them being our CMV vaccine, our hMPV/PIV3 vaccine that is currently dosing children as well as our Zika vaccine and some of the other vaccines that are in preclinical development currently.

Okay. Good. So I believe it was back in May, we got a first glimpse at a Phase I clinical trial data. Three different doses were evaluated, as I recall. We -- you were able to tease out the data and recognize that the 100-milligram dose would be the best way to move forward with. Can you talk a little bit about how you -- we think about dose? And what were the parameters around that decision to move forward with the current dose that you're evaluating in Phase III?

Sure. So the current dose in Phase III is the 100-microgram dose, which you're correct, was part of -- was one of the 3 doses that we tested in the Phase I trial. Recall that when we were moving into the Phase I study, it was merely few -- actually, a couple of months since the -- since SARS-CoV really came to existence. And so there wasn't a ton of research that one could do in terms of figuring out the dosing at that point in time because it's a brand-new virus. So what we did is we dose escalated through that Phase I study to home in on that 100-microgram dose. And what we found is that the lowest dose that we tested, which was 25 micrograms and the highest dose that was tested, which was 250 micrograms, did it have as desirable as a profile as that middle dose the -- if you will, the Goldilocks-type dose in the middle. The 100 micrograms was then chosen to be taken forward, and that is what was in Phase III and what we just reported out as the dose that went into the final clinical trial.

Okay. Great. And I think I got my units wrong. I said milligrams. I meant micrograms. So we know that Pfizer, who has a similar vaccine as Moderna's involving a messenger RNA encoded around a lipid nanoparticle of different composition, as we understand, is moving forward with, I believe, 30-microgram dose. How should we think about that? Does that imply that perhaps Pfizer's is more potent than Moderna's? Or are there other nuances involved, do you think, there that lend to the differences in dosage between the 2 vaccines?

Sure. So as I recall during Pfizer's Phase I study, they also were looking at a higher dose and that 30 micrograms was their middle dose. But I recall that they actually had some side effect and tolerability issues with that higher dose, where some of the individuals within that Phase I trial couldn't tolerate the second dose or the boost dose in that 2-dose regimen. As a result, I think, this is why they decided to go with the 30-microgram dose. However, as you know, I'm not internal at Pfizer. So it would be best for you to ask them that question.

Okay. Good. All right. Great. So along the way, you guys launched a Phase II clinical trial and then a Phase III study. We saw some very compelling results from both an interim and a final analysis of the Phase III. Maybe you could just review the results from the final analysis? And talk about why they're so important and so exciting?

Sure. So I'll remind everyone that our Phase III COVE study was a very large study with enrolling a little over 30,000 participants, which were randomized one-to-one, which means half of those folks that were in the trial were in the vaccine arm and the other half were in the placebo arm. And so what we've showed between those 2 arms is that when you are vaccinated after a 2-dose regimen, there is a 94.1% vaccine efficacy, which means that of the 196 events that took place for us to get to our final -- or the primary analysis, the vast majority of folks were protected and did not acquire any kind of symptomatic COVID-19 disease after vaccination. We also found that the safety and tolerability profile was safe, generally safe and tolerable. The results were also very consistent across the subgroups. And the subgroups, I'll remind you, George and the audience, included people of older age, so 65-year-olds and older as well as many ethnic backgrounds. We had African-American, Latino, Asian-Americans in the clinical trial as well. In addition to that, we also enrolled roughly 8,000 people who live with chronic disease or comorbidities. So -- and what we've said, although many of the details will be reported out at a later date, is that we saw a consistent level of vaccine efficacy across those subgroups, as well as a safety and tolerability profile. So very encouraging results indeed.

And how did the demographics in your trial compared to the other trials that we've seen as notably Pfizer's and AstraZeneca's? Are they roughly the same? How should we think about that in the context of comparing relative efficacy across various demographic groups?

I do believe that all of the vaccine manufacturers were aiming to represent the population. However, with -- I'm closer to the Moderna trial, so I'll speak to that one. We did make a very strong effort to be as representative as possible for the U.S. population, which, as you know, the U.S. is a melting pot. So we do think that the COVE study ended up being very representative of the U.S. population and by extension, the world.

Okay. And have you looked at antibody titers in these individuals? I mean that was something that you were very transparent about in Phase I. Is there some way to be able to correlate? Did you see similar antibody titers being generated in the Phase III as you saw in the Phase I study?

So we haven't reported out on the antibody levels as of yet. That data will be available either at a publication or presumably at the VERPAC meeting.

Okay. And that meeting is next week, correct?

That's correct, December 17.

Yes. Can you remind us, like what should we expect from that meeting? I know we have the VERPAC meeting for Pfizer tomorrow. What goes on at these meetings? And what do you expect that we'll be able to learn during the hearing?

Sure. So there was a VERPAC that took place earlier in the year, but this was prior to any of the vaccine manufacturers generating the primary analysis data. And so typical for a VERPAC meeting, which is an advisory committee meeting to the FDA, what is usually discussed are the efficacy results as well as the safety and tolerability results. And whether or not there was a demonstration of a validation on the trial in terms of, is this a approvable candidate? Typically, that's what takes place at adcom meetings, and then there's a deeper detailed look at some of the data as well.

Okay. Good. And while we're on that topic of adverse events, can you talk a little bit about the safety profile of 1273, what you've seen so far to date?

Sure. So we did report out that their -- mainly after the second vaccination, we do see a tolerability and safety profile that can be considered pretty similar to some other vaccines that are already on the market, Shingrix being one of those, where we did see somewhere near a 10% level of fatigue, for instance. But most of these tolerability and safety or adverse events typically resolve within a short period right after vaccination, within a 1- to 3-day time period. There wasn't any need for medical intervention for any of these adverse events. So you may feel a bit of a pain in your arm because you're being injected and you may feel a little fatigued or a headache, for instance, for a day or 2. There can be an Advil or a TYLENOL that helps alleviate some of these. But outside of that, there isn't any major medical intervention that was required.

Okay. Good. So Moderna kicked off a Phase II trial, which we really haven't heard very much about, I believe 600 individuals, half focusing on elderly, half on a generally younger population. What is the latest -- what is the status of that trial? And when do you think we'll be able to see some results from that study?

Sure. So that trial, I'll remind everyone again, was 600 participants in that trial in the younger adult population as well as the older adult population. And what we were looking for, we're neutralizing antibody titers. So similar to the Phase I study, only the N was much, much larger. And we did actually generate safety data that was shared with the regulatory authorities, the FDA, before moving into the Phase III. That study is now completed. We are working through the data. And as you know, there is a scrubbing and cleaning process. And when that data is available for publication, it will be -- you know it will be published. And in that point, you can see it. But we won't see vaccine efficacy per se from that data. That was more reserved for the Phase III trial. It will mainly be more data on neutralizing antibody titer levels.

Okay. Great. All right. Let's move on to manufacturing. This is clearly a big deal. I mean, you have pretty large customer base sensibly that is going to want this vaccine. Can you give us an update on where you are with manufacturing? And what are Moderna's goals for the end of this year and end of 2021?

Sure. So we've said, for the end of 2020, we will have approximately 20 million doses available for the U.S. market, should we obtain emergency use authorization by the end of 2020. For 2021, the range that we've given for supply is on the low-end, 500 million doses; and on the high-end, 1 billion doses. We did also say that we have very good visibility into the low-end. So at a minimum, we're looking to produce 500 million doses in 2021.

And what are the factors that determine that? I mean, the difference between 500 million and 1 billion is quite large. You know how -- what are the gating factors to get to the high-end versus being confined to the low-end?

Sure. So it mainly is the synchronization of all of everything that needs to come together to actually produce product. So some of the raw material inputs, which also may include things like tubing or plastic bags that will house the vaccine before it actually gets vialed. And so the synchronization or having all of the inputs that are required at one particular point in time is what is the key factor that we think still needs -- we need a little bit more visibility on before we can put a stake in the ground and say we're going to be much, much higher than the 500 million doses.

Okay. So you've said 20 million by the end of this year. Assuming you do get an emergency use authorization this year, maybe cutting it close. But let's say, January, would you be ready to start administering the vaccine to select populations? And I guess that's still up for debate as to who will be ultimately be the candidate for the vaccine. 20 million doses implies 10 million participants, right? How are you going to decide who gets the vaccine and who -- actually, who is making that decision? And how is that going to be worked out?

Sure. So great question. The ACIP Committee is responsible for putting out guidelines for who will be in that -- in those priority groups. I do believe that the number or the categories that they're looking at are health care workers and essential workers who, if you think about it, those that are most at risk. They absolutely fall into that category as they are the ones most exposed to the disease as well as the virus. Also, older populations and comorbid populations are also very high-risk. So these are determinations that will be made by ACIP, and those guidelines will be published. And I believe that all the vaccine manufacturers will be adhering to those guidelines once they are finalized.

Okay. Now Moderna has signed a number of supply deals with various sovereign governments. Who gets the vaccine first? And how do you think about prioritizing the demand, 500 million to 1 billion doses? Again, wide range, but you have a lot of customers to satisfy. How are you going to manage all that?

Sure. So I will remind everyone that there are 2 dedicated supply chains: One here in the U.S. comprised of our own facility outside of Boston, Massachusetts as well as our partner facility with Lonza in New Hampshire. And that -- the supply coming out of that dedicated supply chain will be for use in the U.S. Outside of the U.S., our partners, Lonza out of Switzerland, will be supplying the rest of the world. So that's point number one. In terms of -- based on confidential agreements within these contracts, we do have a schedule for when many of these vaccines will be available to those respective parties and that's how we will be treating the distribution of the vaccine once it's ready for distribution.

Okay. And then along those lines, regarding distribution, the vaccine needs to be kept at pretty cold temperatures. How should we think about how the company intends to manage that? When we hear about these subzero temperatures, what does that mean? And how do we -- how does the vaccine actually get transported under such temperatures? And then when it ultimately gets to its destination, what needs to happen?

Sure. So I'll remind everyone that given the efforts of our technical development team, and over the years, having experience with the many other vaccines we've taken through the clinic through Phase Is and into Phase II studies, there's a body of know-how and experience that helped us get to the point that we're at right now with our 1273 vaccine, which is that we can distribute our vaccine at minus 20 degrees Celsius and it is stable at that level for 6 months. And that 6 months is 6 months only because of time. That's the amount of data we've collected thus far. So as we collect more data, that can actually increase as well. The minus 20-degree Celsius is not a formidable below-zero temperature at all because it's the same temperature that many of us have our -- have in our -- or all of us have in our kitchens. It's the same freezer temperature where you keep your ice cream. And for 30 days, the -- our product is stable at normal refrigerated temperatures, which is the same temperature where we keep our milk in our refrigerators. For 12 hours at room temperature, the vaccine is stable as well. So there won't be any special equipment or handling that's required with our vaccine. There's no on-site dilution, for instance. It is as easy as puncturing the vial, taking the amount of vaccine required in one dose out and then administering the vaccine into the shoulder muscle.

Now to the extent that you have any insight into this, Pfizer's vaccine requires much more onerous conditions, I think, for both storage and transport. Why do you think that's the case? Why should -- since these are both nucleic acid and LNP formulations, why should one be required to be stored at colder temperature versus the other? Do you have any views on that?

So that -- we get that question often. And it isn't just one thing. Obviously, there are some differences between our vaccine and their vaccine on some of the chemistries we use. Clearly, the lipid nanoparticle is different. But it's also this manufacturing know-how that we've developed over the years as well. But again, it's not just one thing. It's many things compiled together that help us get to the storage and stabilization conditions that we currently have with our vaccine.

Okay. Good. Let's see. So what about durability? I mean that comes up a lot. I mean you saw these fantastic results from the Phase III trial. How long do you think those results can last in these patients, in these volunteers? How long do you think they'll be protected for? Do you have any views on that?

So that's like the $65,000 question, if you anyone remembers that game show. What we did recently published or there was a letter to the editor of the New England Journal of Medicine, again, results off of our Phase I study that did show that 90 days after the second vaccination, so roughly 3 months-or-so after the second vaccination, antibody titer levels, neutralizing antibody titer levels, continue to persist at very high levels. And so -- and this is across the board in the different groups that we looked at, age groups that we looked at. So that's a strong indication that at least for 3 months of the vaccine will be -- presumably will be effective because the neutralizing antibody titers continue to be high. However, it's only 3 months. And it doesn't really answer the question in terms of how much longer will the vaccine efficacy be as high as it is as in the Phase III. And so those are results that we as well as many of the other manufacturers will be looking for. And let me just take you through an example of how that information will come about. So all of the Phase III trials we'll continue to monitor -- in our Phase III trial, we'll continue to monitor and follow-up with the participants for 24 months after the last vaccination. Throughout that period, there will be blood draws, for instance, as well as monitoring for breakthrough disease. Remember, in a clinical trial, we know exactly when each and every individual has been vaccinated. And so as a result of knowing all of that information and following these people through that 24-month period, we will be able to, again, look for breakthrough diseases. And when breakthrough disease happens, we can correlate it to what the neutralizing antibody titer levels are. And that correlate of protection is really -- people should think of it as a threshold, a threshold above which if you have neutralizing antibody titers. And around that time point that those neutralizing antibody titers are at that level, you are protected from being infected by the vaccine and developing COVID-19 disease. If you're below that threshold, you are no longer considered protected. So that establishment of that correlate of protection is what will really give us the best possible answer to try and figure out whether or not revaccination is required and at what time point.

Yes. What about T cell responses? That New England Journal letter didn't really talk about -- well, it didn't talk about that. It just referred back to the original results, as I recall. Do we know anything more about durability of T cell responses?

So in that New England Journal letter, you're correct. I don't think they talked much about the T cell responses. What we did see in the Phase I study is that there was obviously a population of CD4 T cells, an important population because as many people may or may not know on this call, in order to activate a B cell to become a plasma cell that then generates neutralizing antibody titers, you need a double activation. The first activation is from the antigen itself, the protein from the virus that you're trying to protect with using the vaccine, but also a activated CD4 T cell has to then activate the B cell itself. And so by intuition, one would know that if you have very high neutralizing antibody titers, that would mean that you also have a very high CD4 T cell response. And we did show that as well in the Phase I study. We were also able to show CD8 T cell responses, but not to the level as CD4 T cell responses. I will caution people from looking at that data and comparing against trials because assays are different, and we do know that the differences in assays can actually lead to differences in what the T cell populations look like on the CD8 T cells.

Okay. Good. In a perfect world, when does 1273 get full approval from FDA?

So that's a great question. In a perfect world, I would say, sometime in the early part of the spring of next year is when, in the April -- mid-April time frame, is what would be my anticipation for a full BLA. However, as you know, it's a decision that's up to the FDA and they'll make that decision when they're ready.

Okay. Good. And then looking into our crystal balls and hopefully, this pandemic will be behind us, lots of people have been vaccinated. Hopefully, we'll be going about our daily lives in a much more normal fashion. What does this market look like? How does -- thinking about top line growth for Moderna, thinking 1273 is certainly one of the major line items there. What does that look like in 2022, '23, '24, going forward since this virus is probably here to stay for a long time?

So I'll tie that back to, first and foremost, figuring out when the revaccination, when and if revaccination occurs. So that data is still yet to be determined through the Phase III studies, as we just talked about. But then in the endemic phase, people should think about the endemic market much like they think about any other market where market forces will be a big determinant, right? And what are those forces? They are how many vaccine manufacturers are competitive? What are the competitive profiles for the other vaccines, both on vaccine efficacy as well as safety and tolerability? Pricing is another consideration that should be taken into account when thinking about what the endemic market looks like. So lots of unknowns at this point in time, however, given that we've already published our results and are very pleased with our results, we feel like there's a good opportunity for mRNA to be a large player in the endemic market.

All right. Good. All right. Well, certainly, hoping for the best with 1273. Certainly, Moderna is playing a very big role in managing the scope of this pandemic, and hopefully, everything will be resolved soon. Maybe we could shift gears a little bit and talk about some other programs going on in the company. Specifically, I'd like to talk about your cytomegalovirus vaccine. And certainly, Moderna has kind of disrupted the time lines of vaccine development. Other developers have followed suit. Should we think about the company being able to accomplish the same with the CMV vaccine? Or is that going to be following, say, a more traditional development path?

Great question. So let's think about what happened this year. There was a lot of accommodation from regulators around the world, allowing for parallel clinical trials running. So prior to the Phase I fully reading out, we were moving into the Phase II. And prior to the Phase II fully reading out, we were moving into the Phase III, all the while making sure that safety wasn't compromised at all for any of the participants. Because in vaccine studies, you do get to see the safety profile, the acute safety profile much sooner than you actually see the neutralizing antibody titers or the vaccine efficacy data. So that accommodation, given the situation that we're all in, in terms of being in the middle of a pandemic, may or may not be replicated in ensuing years when there isn't a pandemic. However, there are other attributes of this pandemic that I think all of the companies, particularly, in our case, Moderna can learn from. So I'll tell everyone a story, for instance. Prior to COVID-19, we were looking at moving into a Phase III with our cytomegalovirus vaccine. And in talking with the regulators in terms of what the primary analysis should look like in our Phase III, we computed that we would require 8,000, roughly 8,000, maybe a little bit less than 8,000 participants in our Phase III trial based on the conversations we had with regulators. And at that point in time, 8,000 -- an 8,000-participant trial would have been the largest trial that Moderna would have run. And so there was some skepticism given that we hadn't done it before and hadn't shown that we can execute on such a large trial. Fast forward to 2020, in the midst of a pandemic, we were able to stand up a trial, develop the relationships and run a trial with 30,000-plus participants. So that experience, the relationships that have been created with the various clinical trial centers that obviously helped us get here, the relationships with our CROs, I think, is going to be leverageable in terms of executing on other clinical trials in the vaccine space within our pipeline.

Okay. Good. And can you give us an update on some other vaccines that are in development as well, notably a Zika vaccine as well as vaccine against other respiratory viruses?

Sure. So as we talked about earlier, and there are many other vaccines in clinical development, CMV, I'll -- we mentioned, it is the furthest [ per ] month next few that we're going to talk about because we do anticipate it's going to move into a Phase III next year. I'll remind everyone that CMV, we consider it to be a very large product opportunity. CMV causes is the leading cause of major birth defects in the U.S. and other developed countries. And there isn't anything out there for it. There isn't a vaccine currently on the market for against CMV. And so first and foremost, it would be very important to get this vaccine out there for that population, women of child-bearing age. But we do think that it could be a $2 billion to $5 billion annual revenue opportunity. So we're very excited about CMV. Zika is another vaccine that we just reported Phase Is details on, and we are preparing to move into a Phase II there. hMPV/PIV3 are 2 respiratory viruses in a combination vaccine that, again, is also in a Phase Ib. And currently, dosing children, so toddlers at this point in time because, ultimately, it will be a pediatric vaccine. And then we also nominated earlier this year as a development candidate, our RSV vaccine, the pediatric setting, and that nomination took place in February of this year. And we announced in September that we started the Phase I study. So we're already dosing healthy volunteers in that study as well. What's important to note here, and I'll remind everyone, because I know that we did probably mention this earlier, but the technologies, the mRNA technologies and the lipid nanoparticle technologies that are used in all of those vaccines that I just mentioned, are exactly the same as that that's being used in our mRNA-1273 COVID-19 vaccine. So the database that has been generated thus far and will continue to be generated through the use of 1273, will, I think, be very important in forming a solid foundation of both safety and tolerability for the other vaccines as well.

Okay. Great. I'd encourage audience members to submit any questions into the chat. I did get a question in advance. Going back to 1273, the U.S. government has provided Moderna with a lot of grant funding to get to this stage and has been quite instrumental in helping to -- with the capital commitments in manufacturing, et cetera. Are there any obligations that are due back to the federal government? And any sort of royalties or kickbacks that need to be considered?

So I will say that we did reflect the help from the U.S. government to the tune of about $1 billion for the development and clinical trials for Phase II and Phase III of the late-stage development. And we reflected that in the pricing for the U.S. government, where when you include the BARDA funding, it is $25 per dose. And then excluding it, it's $15.25 a dose. So it was reflected in the pricing for our vaccine. In terms of royalty due back, I draw -- it was a grant. So there wasn't -- we haven't commented on any royalty due back to the U.S. government as a result of that grant.

Okay. Great. And maybe, Lavina, just in our remaining time, I just want to remind the audience that Moderna is more than just a vaccine company, it's also a therapeutic company. I was struck by some pretty interesting results that came out of SITC regarding 4157, this kind of head and neck cancer therapy -- well, cancer therapeutic that showed some encouraging activity in head and neck cancer. Can you talk a little bit about that? And when should we expect to see some more data from that program?

Sure. Thank you, George, for talking about some of the other programs we have in development. So PCV, which is our personalized cancer vaccine, is currently in both a Phase I study in various different cancers, as well as a randomized Phase II study in adjuvant melanoma, which is head-to-head against KEYTRUDA. So it'll be PCV plus KEYTRUDA versus KEYTRUDA alone. That's a Phase II study that's ongoing and has not recorded out results as of yet. From the Phase I study in head and neck cancer, in a cohort of patients with head and neck cancer that was HPV-negative, in a very small cohort of patients, 10 patients, we did show a 50% objective response rate, which is encouraging, but albeit early and very small in terms of the number of patients that were in that trial. But it compares very nicely to the 16% response rate that KEYTRUDA showed and is now approved in -- for that indication. We also did show that out of the 5 objective responses, 2 of those were complete responses. And so let me remind everyone what a complete response is. It's when you no longer can measure the tumor. And so very encouraging results, indeed. The company has decided to expand that cohort and to look to see if this signal continues to persist with more patients in it. In terms of timing of when we'll see additional data, as you know, in oncology, it can be a wild card in terms of trying to figure out exactly when timing -- when you're trying to time results because patients will progress on their own schedule. And depending on their own prognosis. And so very hard to say exactly when. But if you look at our cadence, in terms of when we've reported out results for oncology, it's typically been around major medical meetings. So should we have any data around any of the major medical meetings, we will presumably want to present that data there.

Okay. Great. Well, Lavina, thank you so much for your time this morning. I really appreciate the update. And wishing everyone happy holidays, and best of luck at Moderna with your progress going forward.

Thank you, George. Happy holidays, everyone.