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Moderna, Inc. (NASDAQ:MRNA)
Q2 2018 Earnings Call
Aug. 7, 2017, 8:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning, and welcome to Moderna's second-quarter 2019 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 that the 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.

Lavina Talukdar -- Head of Investor Relations

Thank you, operator. Good morning, and welcome to Moderna's second-quarter 2019 conference call, to discuss business updates and financial results. You can access the press release, issued this morning, as well as the slides that we'll be reviewing, by going to the investor section of our website, at www.modernatx.com. Today on this call, we have Stéphane Bancel, our Chief Executive Officer, Stephen Hoge, our president, Tal Zaks, our Chief Medical Officer, and Lorence Kim, our Chief Financial Officer.

Before we begin, I would like to remind everyone that this conference call will include forward-looking statements. 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 undertake no obligation to update or revise the information provided on this call, as a result of new information or future results or developments.

I will now turn the call over to Stéphane.

Stéphane Bancel -- Chief Executive Officer

Thank you, Lavina, and good morning, everyone. We believe mRNA has the potential to be a new class of medicines. We believe mRNA medicines have the potential to address large unmet medical needs and to treat diseases that are not addressable by recombinant proteins, or small molecules. Due to the platform nature of mRNA, we believe our mRNA medicines provide a higher probability of technical success and faster timelines to clinical trials, and to markets, relative to traditional medicines. We also believe that the manufacturing capstone intensity of mRNA is materially lower than recombinant proteins and that the manufacturing costs at commercial scales will be similar to small medical injectable.

Because of this loss potential, we continue to focus on managing the risk, across our portfolio, especially technology risk, and biology risk. We believe that programs within the same modality of similar technology risk, meaning that once we de-risk a section of the program, there are important withdraws. As a key [inaudible] in the near future, we [inaudible] our chikungunya antibody program, would be an important clinical readout, as it uses the same formulation technology as our mRNA program, our most advanced readiness candidate.

Our corporate focus is on three priorities. First, to execute on the development pipeline. Two, to move new development candidates in existing modalities from the lab into the clinic. And three, to invent new development candidates in new modalities.

I will review now our most important progress since our last quarterly update in early May, starting with PCV, personalized cancer vaccine. We presented positive [inaudible] phase one data at the ASCO meeting in June, and since, we are happy to report today that since ASCO, we started a phase two head-to-head trial in the adjuvant melanoma setting. We look forward to the readout of this important immunotechnology program, to assess if PCV plus [inaudible] can increase recurrence-free survival, [inaudible] immunotherapy.

We're happy to report today that the phase one for CMV has completed, and [inaudible] healthy subject, at doses up to 300 micrograms. We believe CMV is a large unmet medical need, and we look forward to reviewing and sharing the phase one trial data in the near term.

The team continues to execute a directive base in the last 90 days. We advanced four new programs into phase one since our May quarter. Two programs in immuno-oncology started dosing cancer patients. Our KRAS vaccine, which is partnered with Merck, and the IL12 [inaudible] program, which is partnered with AstraZeneca, dosed our first patients. Two programs in infectious vaccines started dosing as well. Our RSV vaccine, mRNA 1172, partnered with Merck, and our Zika vaccine, mRNA 1893, which is funded by the US agency BARDA.

Finally, I'm happy to report that clinical sites are now open, and actively reporting patients in our first readiness program, MMA. We have three sites in the US, and in the UK, the clinical [inaudible] application of CT has just opened by local authorities. I am very pleased with the company's progress, and I'm very thankful for team dedication to this execution. We now have five immuno-oncology programs in the clinic, including PCV phase two, and OX40, soon entering two. We have five important [inaudible] programs, and our team is working out to do the first MMA patient, and to submit INDs for all our readiness programs. We have four vaccines in the clinic, for major unmet medical needs: CMV, RSV, the hMPV/PIV combo, and Zika. I want to remind you that there are no approved vaccines for any of these harmful pathogens, that severely affect thousands each year. We are very pleased to have completed and [inaudible] our CMV trial, and we look forward to sharing the data with you soon. The company has never been as strong, and we're also [inaudible] continuing to execute and share our progress in the months to come.

With this, let me turn to Tal to give you some more color on the current pipeline.

Tal Zaks -- Chief Medical Officer

Thank you, Stéphane. As you know, we are advancing our pipeline of medicines in six different modalities. In the next few slides, I will highlight the progress we've made this quarter in each of these. So, starting with prophylactic vaccines, on slide 13 you will see we have eight programs in this modality, and we've made significant progress in the last quarter. In total today, we have safety data from over 100 healthy volunteers who have participated in our phase one study, and we remain pleased with the emerging safety and tolerability profile of our vaccines.

 I'm happy to report that our CMV program with mRNA-1647 is now fully enrolled in the phase one trial, and I'll go over this opportunity in greater detail in just a moment. The RSV phase one study testing, mRNA-1172 dosed its first subjects in this quarter, and recall that, at the last quarterly update, we reported that our partner, Merck, had just filed the IND.

Our Zika program with mRNA-1893 also had the IND filed and opened in the second quarter, and I'm happy to report that the first subject in the phase one zika trial was also dosed.

In terms of emerging data, in hMPV and PIV3, or mRNA-1653, we continue to see neutralization titers above baseline, at the second interim look, seven months after the lab's vaccination. For context, in January, we reported the tow-month immunogenicity data. We plan to present the full data from this study at ID Week, in the fall.

We are also pleased with the feedback from FDA regarding the development plans for mRNA-1653, where we discussed the potential fast forward to evaluate protection against both hMPV and PIV3 in a single phase three study. Consistent with these plans, we plan to enroll seropositive toddlers in our next trial.

Finally, the phase one data for influenza vaccines against H7 and H10 were published in the journal Vaccine.

Let me now spend a few minutes on CMV. As noted, before the phase one trial for CMV is fully enrolled, CMV is a common pathogen that is a leading cause of birth defects. The burden of disease is significant, where approximately 25,000 newborns are infected each year in the US alone. Currently, there aren't any vaccines against the CMV virus on the market. That's because CMV has proven to be a challenging vaccine to manufacture using traditional technologies, given the structure of one of the antigens, the pentamer, which we think is required to elicit a protective immune response. We believe these challenges can be overcome with our mRNA-based vaccine, as our technology lends itself to producing the pentameric viral antigen, by encoding for the simultaneous translation of its five components.

As a reminder, and as shown on slide 15, mRNA-1647 actually contains six mRNA sequences, five of which encode for this pentamer, and one that encodes for the gB protein. We believe the combination of these two antigens, encoded mRNA-1647 will produce potent and durable antibody titers against CMV, that have the potential to protect against infection. We look forward to the phase one results soon.

Let me now turn to cancer vaccines. You will see the programs in this modality on slide 17, and I will focus on mRNA-4157, our personalized cancer vaccine, and on the KRAS vaccine, mRNA-5671. Recall that we and our partner, Merck, announced the phase two trial earlier this year. The phase two design is a randomized trial, testing the combination of mRNA-4157 in combination with pembrolizumab, against a pembrolizumab monotherapy control arm in high-risk melanoma patients in the adjuvant setting. I'm happy to report today that phase two is up and running and that the first patients have consented to the trial.

Interim safety, tolerability, and immunogenicity data from our phase one were the basis for the decision to move to phase two. We presented these interim data with mRNA-4157, either as monotherapy in a restricted adjuvant population or in combination with pembrolizumab in a metastatic setting. These two arms were present, arms A and arms B, respectively, in the phase one study. We have a part C and part D that continue to enroll. Part C histologies include microsatellite stable or MSS colorectal cancer, and head and neck squamous carcinoma. We and our partner, Merck, have also added an additional cohort in part B, where we will be testing the combination of mRNA-4157 with pembrolizumab in patients who are refractory to PD-1 inhibitors.

Turning now to the interim results we presented at ASCO of this year. We showed that mRNA-4157 was safe and well-tolerated, with no reported DLTs, and no grade three or grade four adverse events. We also showed that mRNA-4157 elicited neoantigen-specific T-cell activation in 10 of the 18 class one neoantigens, in the one patient treated at the top does, where apheresis was performed. While these data were obtained with the first version of our vaccine, that included up to 20 neoantigens, we're now selecting for up to 34 new antigens, using our proprietary algorithm. For the data presented at ASCO, the patients were dosed with the PCV that had 20 neoantigens, and all patients who have enrolled since April in both the phase one and phase two studies have been receiving the 34 neoantigen version. At ASCO, while the clinical data are early in preliminary, we did report six responses in part B of the study, in the metastatic setting. One of these was a complete responder to pembrolizumab monotherapy, prior to receiving the personalized cancer vaccine, and five other dosed with the combination of mRNA-4157 and pembrolizumab had a partial response. Two of these five PRs were patients who were previously treated with JAK-1 inhibitors. While these early signals are trending in the right direction, we believe that our phase two trial will help us and Merck to definitively ascertain the incremental benefit of mRNA-4157.

Moving now to the KRAS vaccine, I'm also pleased to announce that the first patient in our phase one trial testing KRAS vaccine, mRNA-5671, was dosed. As a reminder, KRAS is a key regulator of self-proliferation and survival. Mutation in the KRAS gene causes disregulated self-proliferation, and that's one of the best-studied oncogenes. It is the most commonly mutated oncogene, and it drives over 20% of human cancers, predominantly in the pancreatic, lung, and colorectal cancers. Indeed, the team at the NCI, led by Steve Rosenberg, had shown at the end of 2016 that the recognition of a mutated KRAS epitope by T-cells can lead to cancer regression.

A quick overview of mRNA-5671 is shown on slide 21. It encodes for the four most prevalent mutations of KRAS, which together represent 80 to 90% of KRAS mutations. The genetic sequences that span the mutations are combined into a single mRNA that encodes for all neoantigens. When translated within the cell into a neoantigen protein chain, the cellular proteasomal machinery is expected to cleave the chain and present these neoantigens to the immune system, to stimulate what we hope will be an active anti-cancer T-cell response.

The phase one trials for this vaccine, which is being run by our partner, Merck, has enrolled its first to, and the study will evaluate safety and tolerability of mRNA-5671, both as monotherapy, and in combination with Keytruda, in patients with metastatic non-small cell lung, colorectal, and pancreatic cancers, that harbor the KRAS mutations. Of note in this trial, we are selecting for specific HLA subtypes that, based on the science, are most likely to respond.

For the intratumoral immuno-oncology programs, we're progressing with all three of our development candidates, OX40 ligand, the Triplet, and Interleukin 12. Starting with mRNA-2416, which encodes for OX40 ligand, which you will recall is a potent co-stimulator that promotes T-cell proliferation. The phase one is completing the dose confirmation cord at eight milligram, and in parallel, we're progressing to start the phase two cohort, in patients with advanced ovarian cancer, Slide 26 shows the schematic of the phase one trial, and the phase two cohort.

Turning to mRNA-2752, or the Triplet, which encodes for OX40 ligand and two pro-inflammatory cytokines, interleukin 23 and interleukin 36 gamma. The rationale here is to stimulate T-cells through the presence of OX40 ligand, while attracting the T-cell to the tumor site, with the local expression of these cytokines. By injecting the tumors directly, we expect the cytokines to act locally, within the tumor microenvironment. The phase one is ongoing and has both a monotherapy arm and a combination arm with durvalumab. I'm pleased to report that the first patient in the combination arm with durvalumab has been dosed.

We've also made progress with MEDI1191 in our interleukin 12 intratumor injection program, partnered with AstraZeneca, as the first patient in this trial was dosed. Recall that interleukin 12 is a potent immune modulator, associated with the type one interferon response, and production of interferon gamma. Its activity against cancer has been described in the literature, but safety has been a problem when interleukin 12 has been administered systemically. We believe that the intratumoral mRNA approach should allow for interleukin 12 to act locally in the tumor microenvironment while avoiding the toxicity seen with systemic administration.

Let me touch, for a moment, on the localized regenerative therapeutics, and AZD801. The phase 2a in coronary and arterial bypass population is ongoing. Our partner, AstraZeneca continues to open additional sites in Europe, with a clinical trial application now also open in Germany.

Let me move ahead to our systemic secreted therapeutics, and I will focus on mRNA-1944, our antibody against the Chikungunya virus. As of today, we've enrolled six of the eight subjects in the third dose cohort. Before I get to the trial design and the strategy around this program, I want to take a look at the program, which is DARPA funded. mRNA-1944 encoded for an antibody against Chikungunya. Now, antibodies are a complex protein that require both a heavy and a light chain to come together to form an active protein, so mRNA-1944 actually includes two mRNAs, one that encodes for the heavy chain and one that encodes for the light chain. Once formed, we expect the antibody to be secreted into the bloodstream, where we will be watching to see if it confers passive immunity against the Chikungunya virus, as expected.

On slide 36, you will see the trial design. The key objectives of the trial are to evaluate the safety and tolerability of four single, ascending doses of mRNA-1944, and to evaluate the pharmacokinetics of the drug, and the pharmacodynamics of the anti-chikungunya virus antibody levels, which together will describe a dose-response curve. We're collecting assay data, to see if the antibodies neutralize the virus, which we believe will ultimately speak as to whether or not this antibody we encode for is indeed functional. Now, the utility of this program is really twofold. One, first, as a product that could potentially protect against chikungunya infection by conferring passive immunity, and second, as this program uses the same lipid nanoparticle formulation that is shared with our other programs in the rare disease indication that we're pursuing, it could inform the risk profile of those other programs, as well.

Lastly, on systemic intracellular therapeutics, where we have four development candidates, I'll highlight our rare disease programs, methylmalonic academia or MMA, and the closely associated disease, propionic academia, or PA. Both MMA and PA are inborn errors of protein metabolism that are caused by MUT enzyme deficiency and PCC deficiency, respectively.

As you can see, these two acidemias are really on the same metabolic pathway. Now, the prevalence of both is approximately 325 to 2000 patients in the US. Patients are identified during newborn screening, and current regimens are palliative. They consist of strict diet restrictions and oral and IV medications. Really, the best treatment that we currently have available for suitable patients today is a liver transplant.

Both mRNA-3704 and mRNA-3927 encode for intracellular proteins that act within the liver cell and act on the mitochondria. Both programs also have FDA orphan drug designation, EMA orphan drug status, and FDA rare pediatric disease designation, which, upon approval, will qualify the two programs for rare pediatric disease vouchers. The phase one study of our sentinel rare disease program in MMA, with mRNA-3704, currently has three sites open, and we are actively recruiting patients. In parallel, the national history study continues to enroll well, with a total of 71 patients across both MMA and PA enrolled.

Let me close with slide 42, which shows you the breadth of our pipeline in one place. You'll see all the new updates we've announced since December 2018, when we became a public company. And with that, let me turn the call over to Lorence.

Lorence Kim -- Chief Financial Officer

Thanks, Tal. In today's press release, we reported our second quarter 2019 financial results. Please note, these results are unaudited. We ended q2 2019 with cash, cash equivalents and investments of $1.44 billion. This compares to $1.69 billion at the end of 2018. We are reiterating today our expectation for cash, cash equivalents, and investments at December 31st, 2019 to be in the range of $1.15 billion to $1.20 billion, consistent with the guidance given on our call in March.

We remain focused on allocation of our shareholder capital toward value-driving investments in our portfolio and platform. Net cash used in operating activities was $256 million for the first six months of 2019, compared to $10 million in 2018. The numbers include $22 million and $25 million of in-licensing payments in the first quarter of 2019 and 2018 respectively, as cited in the footnote. After the first quarter of 2019, we have no further in-licensing payments and obligations to Cellscript and its affiliates.

Cash used for purchases of property and equipment was $18 million in the first six months of 2019, compared to $66 million in 2018. And then, on revenue, recall that on January 1st, 2019, we adopted the mandated revenue recognition standard, ASC606, using the modified retrospective transition method applied to those contracts which were not completed as of January 1st, 2019. The decrease in total revenue for q2 and the first six months of 2019 as compared to 2018 was mainly attributable to this adoption of the new revenue standard. Revenue for q2 2019 was $13 million as compared to $29 million for q2 2018, and for the first six months of 2019, revenue was $29 million, compared to $58 million in 2018. Total revenue under the previous revenue recognition standard would have been $17 million for q2 2019 and $55 million for the first six months of 2019.

R&D expenses for q2 2019 were approximately $128 million, compared to $104 million for q2 2018, and for the first six months of 2019, R&D expenses were $259 million, compared to $195 million in 2018. The increases in q2 and the first six months of 2019 as compared to 2019 were primarily due to an increase in personnel-related costs, including stock-based compensation, and increase in clinical trial and manufacturing costs, an increase in lab supplies and materials, and an increase in consulting and outside services.

G&A expenses for q2 2019 were approximately $29 million, compared to $21 million in q2 2018, and for the first six months of 2019, G&A expenses were $56 million, compared to $38 million in 2018. The increases in q2 in the first six months of 2019 as compared to 2018 were mainly due to the additional costs of operating as a publicly traded company, including an increase in personnel-related costs, and stock-based compensation, consulting and outside services, and insurance costs. And with that, I'll hand the call back over to Stéphane.

Stéphane Bancel -- Chief Executive Officer

Thank you, Lorence. To close our remarks, I would like to reiterate that our team is focused on executing our priorities, advancing the development pipeline, advancing new development candidates in the existing six modalities, and inventing new modalities. The team at Moderna [inaudible] in the quarter. To summarize, we see the highlights of the quarter. We initiated the PCV phase two trial, with first patients consenting to participate in the trial. Our CMV vaccine study is fully involved. We started four new clinical trials, two in immuno-oncology and two in infectious diseases.

Vertex Cystic Fibrosis [inaudible] collaboration. As you might recall, in July 2016, Moderna and Vertex announced an exclusive self-collaboration and licensing agreement [inaudible] discovery and development of mRNA therapeutics for treatment of CF. Based on pre-clinical work to date, Vertex has extended this collaboration for the first quarter of 2020, with options to [inaudible] based on future progress. Preliminary mRNA data [inaudible] represents a potential new [inaudible] for Moderna.

I am pleased with progress we have made to date, and look forward to the rest of 2019 and 2020, as we approach [inaudible]. I particularly look for the CMV phase one data, and the chikungunya antibody phase one data in the near term. As a reminder, the chikungunya antibody is the first monoclonal antibody encoded by mRNA technology to be dosed in a human. Because RSV and zika are both in healthy subjects, these trials will complete soon, and if positive, we intend to transition to phase two.

We now have five immuno-oncology programs in the clinic, two of which are already dosing in combination with approved checkpoint inhibitors, Merck's [inaudible] PCV, and AstraZeneca [inaudible] for triplet. Our teams, working with clinical trial sites, are focused on the milestone of dosing our first patients with MMA.

We believe that mRNA has the potential to be a new class of medicine. We see a large product [inaudible] ahead of us, and we are energized by the potential to bring this important medicine to patients. Four vaccines for large, unmet, medical needs, where there is no vaccines approved today. That is a unique to help millions, in our search to create large commercial products. Five immuno-oncology programs, which [inaudible] potential to improve a response of PD1 or PD1 checkpoint inhibitors. [inaudible] programs, for conditions like MMA and PA, where children born with a missing or defective protein, urgently need a treatment that services the underlying cause of their disease. The [inaudible], which could postpone the care of patients who have [inaudible].

And this is only the first wave of innovative products. Stephen Hoge and his team are working hard to move new, innovative development candidates from the labs into the clinic. The productivity of our mRNA platform is significant. We dose our first clinical trial in December 2015. In just 3 1/2 years, we started 16 programs in the clinic, and we've had a high success rate.

The team did get 19 IND or CTAs opened by local authorities. We know we have a special opportunity, and we are committed to delivering on the promise of our science, and bringing forward a new class of medicine for patients. I would like to end our remarks by thanking the many people who participate in our clinical studies, including patients, healthy volunteers, and physicians. I would also like to thank the great team of Moderna employees, working hard every day to make our vision a reality. With that, we are now happy to take any questions.

Questions and Answers:

Operator

Ladies and gentlemen, if you'd like to ask a question, please press * then 1. If your question has been answered and you'd like to remove yourself from the queue, please press the # key. Once again, to ask a question, that's * then 1.

Our first question comes from Salveen Richter of Goldman Sachs. Your line is open.

Salveen Richter -- Goldman Sachs -- Analyst

Great, thanks for taking our questions. This is Andrea, on for Salveen. My first one is how are you thinking about positioning for your KRAS vaccine, in the context of growing competition in the space? And then, I have a follow-up.

Tal Zaks -- Chief Medical Officer

Hi, this is Tal. Thanks for the question. Look, first of all, I'm really happy that we finally have therapies that are emerging as effective against KRAS mutations. I think that progress for the field is tremendous. I think it's still early days, so let me make two points. First, the exact nature of the activity, and against which mutations, and in our case, which mutations and which HLAs still needs to be defined. So, I don't see them, even on, if you look at the patient distribution necessarily, as competing.

Second, and I think more importantly, on the fundamentals, I think what our vaccine is trying to do, and what the emerging inhibitors are trying to do, are very different things, in terms of patient benefit. I think the history of small-molecule targeted therapies has been terrific, in the sense that it's translated into real benefit for these patients, but we struggle to turn them into curative-intent treatments. I think, on the other hand, the immuno-oncology approaches were successful, have translated into a much more durable effect. And so, my expectation is, down the road, if both of these approaches are successful, you would expect them to have complementary benefits for the patients. I'm really excited, in the coming years, to see how that story plays out.

Stéphane Bancel -- Chief Executive Officer

And maybe, Stéphane, just to add one thing, because Tal described in his remarks the mRNA that we designed is actually coded for mutation, you know, G12D, G12V, G13d, and G12C.

Salveen Richter -- Goldman Sachs -- Analyst

Great, and then, just on your MMA program, how many patients right now are enrolling in your clinical study, that has been rolled over from the natural history study?

Tal Zaks -- Chief Medical Officer

So, in the clinical study, we have not yet enrolled. We are actively recruiting. In the natural history study, there have been 71 patients enrolled to date.

Salveen Richter -- Goldman Sachs -- Analyst

Sorry, do you anticipate, I guess, rolling any patients over from that natural history study, or no?

Tal Zaks -- Chief Medical Officer

It is a possibility. We're looking at it.

Salveen Richter -- Goldman Sachs -- Analyst

Got it, thank you so much.

Operator

Our next question comes from Matthew Harrison of Morgan Stanley. Your line is open.

Matthew Harrison -- Morgan Stanley -- Analyst

Hey, good morning. Thanks for taking the questions, two for me. So the first one is can you comment broadly how we should think about safety so far in the chikungunya study, given that you're through, almost, the third cohort? I don't know if you can comment on what the stop-and-gos are, from a safety standpoint. And then, second question is on OX40 ligand. Can you talk about what you need to do in the space to start to be able to pitch that to the FDA? I guess what I'm asking is, how can we think about potential regulatory tests forward with that module? Thanks.

Tal Zaks -- Chief Medical Officer

Sure. Let me start with the chikungunya. The study is ongoing, so I can't really comment on the data until we see the totality of the picture there, and then we'll describe it for you. It's a healthy volunteer study, so stopping rules are what you'd expect in these typical studies.

In terms of OX40 ligand, the regulatory path, if you look at where we're expanding into the phase two cohort, we're going over ovarian cancer. I think, in that setting, checkpoint inhibitors are not yet approved, and so, if we can -- and it's because they really have marginal activity as monotherapy. If we can demonstrate that the combination has a clear benefit to patients, I think the path to approval will be relatively straightforward, so that's how we're looking at it.

Did that answer your question, Matthew?

Matthew Harrison -- Morgan Stanley -- Analyst

It did, thanks, Tal.

Operator

Our next question comes from Ted Tenthoff of Piper Jaffray. Your line is open.

Ted Tenthoff -- Piper Jaffray -- Analyst

Great, thank you very much and thank you for the update, lots of good progress. So, my question, and I apologize if this was asked, but with respect to the Triplet, my concern here is certainly not activity, especially with durva. But are you doing any special immune safety analysis, or any special additional safety analysis, just because of the potential potency of the triple therapy? Thanks.

Tal Zaks -- Chief Medical Officer

Thanks, Ted. That's a really good question, and I wish I had a wiser answer for you. The reality is that we're looking at the safety, I think, in the traditional way that people do in clinical trials, maybe colored by a better understanding over the years of what the safety protocol of the checkpoint inhibitors alone is. And so, we're looking for, you know, whatever autoimmune phenomena, et cetera, and all the other adverse events that one would expect from checkpoint inhibitor monotherapy, and assessing very carefully to see whether we exceed it.

If there's any other safety signal that is attributable to the triplet, then I think we've got two ways of finding it. First, recall we're dosing as monotherapy, so that'll give us a clear view on the safety profile just of the triplet. And second, in the combination arm, we're looking carefully at all the clinical characteristics, and unfortunately, I think, as a field, it's very hard to predict the adverse reactions that one sees, and they're not very frequent.

So, all you can do at this point is maintain a careful visual for what's expected, and make sure you're not missing anything unexpected. I don't know if that answers the question. I'm not sure I've got a better one.

Ted Tenthoff -- Piper Jaffray -- Analyst

That's alright, that makes a lot of sense. I appreciate that. And then, just a really quick, high-level question. With respect to the CF collaboration, are there any novel delivery modalities that are being incorporated for that disease, or is this really the aim, not just treating lung, but really, systemic disease? Thank you.

Stephen Hoge -- President

So, Ted, It's Stephen Hoge.

Ted Tenthoff -- Piper Jaffray -- Analyst

Hey, Stephen.

Stephen Hoge -- President

So, first of all, it's a research collaboration with Vertex, and we're excited to continue it, based on pre-clinical progress to date. As a part of our general research activities, we do look broadly at a range of different delivery modalities. We have, obviously, made progress in one direction here, but we haven't yet defined a development candidate, at which point we'd probably provide specifics about that. Generally, our approach with Vertex and CF has been to address the unmet needs in CF, particularly for those patients who adults for CFTR, and focusing intensively on the pulmonary disease. But obviously, without commenting specifically on the CF example, pulmonary delivery is a route of administration that could be valid for other systemic diseases or other applications as well.

Ted Tenthoff -- Piper Jaffray -- Analyst

Great, thanks a lot. I'm looking forward to the -- Yeah, sorry, go ahead.

Stephen Hoge -- President

No, that's it, yeah.

Ted Tenthoff -- Piper Jaffray -- Analyst

Great, awesome. I'm looking forward to the CMV data, and see you guys in September. Thanks.

Stephen Hoge -- President

Thank you.

Operator

Our next question comes from Cory Kasimov of JP Morgan. Your line is open.

Cory Kasimov -- JP Morgan -- Analyst

Hey, good morning, guys. Thanks for taking my questions. I have two, as well. So, I guess, first, if you could just walk us through the cadence of what you see as the key validating clinical updates we should expect in the next 12 months or so. Beyond the CMV and chikungunya updates, what else has a chance of occurring in that time period, and will we see new clinical data at your R&D day in September? And then, I have one follow-up.

Stéphane Bancel -- Chief Executive Officer

Cory, good morning, it's Stéphane. So, I wouldn't comment on the R&D day. I hope you come to the R&D day. We will make sure we give a good update on everything we know then. On the next 5 months, as you can see in slide 46 on the presentation, as I discussed in my comments, CMV is really important, as you know, we really [inaudible] very large opportunity. We own 100% of the economic of this product. We believe it's a very large medical need out there. And so, the CMV data are gonna be really important [inaudible] for company.

RSV and Zika, because they're in phase one in healthy subjects, and they are dosing as we speak, should read pretty quickly, and as I shared, the plan is to move those to phase two, assuming we have good data, into the clinic. I remind you that we have already, in the past, shown in a good [inaudible] from primates into humans, into our vaccines that have palliative data. And so, we look forward to this data in human.

PCV, of course, will take a little bit of time, because we started phase two. That's a very important study. [inaudible] phase two, we know 150 patients across the board, and then it's patients, of course, with cancer [inaudible].

KRAS is gonna be interesting. We all believe there's [inaudible] tumor types, so we have therapy in two patients in phase one, so we'll be sharing observations at the planned clinical meetings, of what we see in the clinic. In the intratumoral, because it's oncology and we've got dosing, you know, the triplet is in combination with PD1. OX40 will be in phase 2 soon, and also will be in combination with a checkpoint. NAD [inaudible] IL-12 [inaudible]. same thing, we will update the different medical meetings and clinical observation, except is recruiting.

And then, as we discussed, the chik antibody is very important for us. And then, getting the test ready in the clinic. The [inaudible] are gonna go straight into patients, as we commented before, we are starting MMA as a dose that has been showing in our models as having some benefit. And so, I think the next few months and the next few quarters are gonna be quite rich, data-wise. We have[inaudible] drugs for [inaudible] in the clinic. That's a lot of potential data as well.

Cory Kasimov -- JP Morgan -- Analyst

Okay, great. And then the follow-up is regarding your personalized cancer vaccine, 4157 program. And near-term plans for exploring indications beyond resected melanoma patient that are at high risk of relapse, or PD1 refractory? What do you see is the potential of this program in indications that may have considerably less neoepitopes?

Tal Zaks -- Chief Medical Officer

Thanks for that, Cory, it's Tal. You know, it's a question that we've asked ourselves since the beginning of this program. I think, strategically and philosophically, what we want to do with this program is first, to go where the likelihood of success is the highest, before we look for areas that are more challenging, and so, that's why we've focused in the histologies that we have in phase one, and that's why we went into an adjuvant setting even within melanoma, for a definitive study in phase two. I think, once we have a clear proof of concept, clearly we will begin to explore some of those additional implications, but there's not any current plans to do that.

Stéphane Bancel -- Chief Executive Officer

And Cory, Stéphane, to add to Tal's remarks. If you think about it, going back to Lorence's comments, We are very [inaudible] location, so of course, there could be a lot of different things one could think of trying with personalized cancer vaccine, as you think of all of our patients that we have teated to date. But unfortunately, in the week before, we have an important de-risking, we cannot expand too much, because we have so many important [inaudible] products across the portfolio, who could be including the [inaudible] that will not be reasonable.

And so, we want to be very disciplined, and that's just one example. There's a lot of things, trust me, that the clinical team, as you know, study in oncology by trying -- who love to try anything to help those patients. But we just have to be very disciplined in regards to the location, and how much we spend and where we spend it, and when we spend it, based on the risking.

Cory Kasimov -- JP Morgan -- Analyst

Okay, that makes sense. Thanks for taking the questions.

Stéphane Bancel -- Chief Executive Officer

Thank you.

Operator

Our next question comes from Alan Carr of Needham. Your line is open.

Alan Carr -- Needham -- Analyst

Hi, this is Jennifer, speaking for Alan. I have a couple of questions. First question is, I was wondering if the team can give us some color on the commercial strategy, and possibly, specific patient groups that you may be planning to target for the CMV assets? Thank you.

Stéphane Bancel -- Chief Executive Officer

So, thank you, Jennifer, for the question. It would be great if you can join us at the R&D day, be we will spend quite some time on CMV commercial opportunity. As we discussed in the past, there are many populations from the women in the age of bearing a child, adolescent women who might want to protect. There was also discussion about partners of those pregnant women. There's also discussion, because [inaudible] CMV, do you go down in age to try to eradicate CMV? So, there's a lot of different segments that we will discuss quite at length on the R&D day.

But this is why I think we believe CMV, if you take a 10, 20 year time frame, and if you look at all the old vaccines, like the HPV vaccine and the personal vaccine, those very important vaccines, the life cycle management of those products can be very important, and we have our eyes very much on how do we go about this. Again, we cannot do all the indications at the same time. It's going back to [inaudible] location and investments. But we are very much in mind of how to maximize with them this opportunity, to get the largest label that we can for CMV, so it can be given to the largest population we can, around the world and in the US.

Alan Carr -- Needham -- Analyst

Oh, thank you so much. The other question is, for the hMPV/PIV3 vaccine, could you possibly give us some comments or color, any new understanding of the titer level needed to progress this effort? Thank you.

Tal Zaks -- Chief Medical Officer

This is Tal. I think that our understanding of the titers there is going to be based mostly on the pre-clinical modeling, and what we've seen to date that is protective. Unfortunately, there is no vaccine on the market, so we don't really have a correlative protection like we do from influenza, but it is a respiratory virus, so one draws similar parallels from the experience with flu, and you get a sense from the totality of our understanding in the science on the respiratory viruses, what are the titers like.

I think what we've seen in the phase one is supportive of our ability to immunize. Recall, though, that the target population here is in seronegative infants, right. So, ultimately, we're going to have to define our ability to reach significant titers, and boost to the maximum the immune response capability to respond, in that population, down the road. So, I think it may not be a very black and white answer, because I think that will take inference from multiple lines of reasoning, from science and from clinical studies, and from other vaccines, I think, to come to that. Does that help you?

Alan Carr -- Needham -- Analyst

Thank you for taking the questions. Yes, thank you so much for taking my questions.

Tal Zaks -- Chief Medical Officer

Thanks, Jennifer.

Operator

Our next question comes from Hartaj Singh of Oppenheimer and Company. Your line is open.

Hartaj Singh -- Oppenheimer and Company -- Analyst

Great, thank you for the questions. I just have two. One is, I know that you mentioned the chik antibody is very important. Can you just talk, maybe, a little bit about that if you see the proof of concept, manufacturing the antibody using an mRNA, and then see efficacy on the vaccine side, you know, antibodies are over $100 billion in sales per year. What are other areas could you go into? Would you see yourself being in vaccines? Are there other types of antibodies, other types of diseases that would be amenable to your approach, in that regards, or is that just looking too far into the future? And then, I got a quick follow-up.

Stéphane Bancel -- Chief Executive Officer

So, good morning, Stéphane. So, as you know, we have disclosed all 21 development candidates, and we don't' comment on future plans in research. Obviously, as I said in my remarks, we think it's a very important milestone. It's the first time that, using a modern technology, and antibody is being produced in a human. And so, that's an important technology that, as you commented, has a lot of different applications. What we try to do [inaudible] the portfolio of the assets that we give up, we will show those capital, is to be thoughtful about managing biology risk, technology risk, and to create important innovative products for patients. That's always a big driver for us.

If you look back to one of my closing slides, if you look at the portfolio today, for most of the products in the pipeline, there is no product on the market with big enough medical need, and there's no solution on the market. And so, we are always thoughtful about all those things. But it would, of course, because a very important tool in our Moderna toolbox.

As you know, partnering is a [inaudible] important part of our strategy, and if you go back over time, you know, we've done four partnerships with Merck, a few with AZ. We're very, of course, happy with [inaudible] to expand the collaboration. And so, that's so technology can be made available to a partner. So, this is an important piece of the Moderna toolbox.

Hartaj Singh -- Oppenheimer and Company -- Analyst

Great, that helps a lot. And then, I just had a quick question on your manufacturing strategy. I mean, I visited the Norwood facility. Really, really cool stuff going on there. It is clinical grade sort of material and research material. Can you just talk a little bit about how you're thinking about your commercial-grade material? I mean, you're getting to the point now, where, you know, you might have one or two, you know, other rare diseases where you might be able to get to the clinic fairly rapidly, and the regulators want to see a sort of clinical to commercial sort of strategy. Can you just talk a little bit about that? And then, which of your modality actually requires more intensity, from a commercial manufacturing perspective, than others? Thank you.

Stéphane Bancel -- Chief Executive Officer

That's a great question. So, on the commercial front, as we've shared in the past, Norwood is able to do commercial, but it's not ready today. We have to do much work around validation and the quality systems and so on. But the infrastructure of the plant itself has been built so that the site can be brought to commercial readiness, and be able to do pivotal studies, restriction studies, out of Norwood.

What we also shared, and it's again, going back to our focus on managing the risk, we will not have to be the commercial facility before we have our first commercial product approved. That's a very important part of Moderna's strategy to de-risk the company. So, we can launch products out of Norwood. We can do phase three out of Norwood. We will get the site ready on time so that we can do that. We also, with our contract manufacturer strategy, we never want to be single source for the company. That would be way too risky So, we have, as we speak, contract manufacturers that have some commercial capabilities from their site, and that go into the system already.

And, if you think about the different products in the portfolio, which is a second question, the thinking path is mostly on the back end, which is around filling the virus. Because if you think about it, mRNA for vaccines, the doors are very, very tiny, so you don't need a lot of mRNA drug substance to supply actually millions of virus. Because you go back to the data we have published, our vaccines show efficacy at 2500 micrograms per human. So, in [inaudible] do a lot of doses, this can do enough. And so, and [inaudible], because at the end of patients, it's low. You saw, don't go into gigantic quantities. Of course, you know, [inaudible] is a different ballgame, but again, that would be a very happy program to manage, when we get there.

On the back end, no, it does not have the capability to do millions of vials of fillings, but that's something that is regularly available from contract manufacturing. So, that is why we feel very confident that we have, with the current infrastructure that we have, we have the ability to do pivotal to commercial. If we're to manage the back end, we need more vial capacity, we get and contract that out. With an existing partner of a new partner, we have time for that.

And, if we needed more capacity, one thing to remember about Norwood is that we can increase the capacity of Norwood tremendously, versus the current capacity. We are only working with two-day shifts. We could, of course, put a night shift. We don't have a shift on weekends. So, right there, you have a lot of capacity available. We can move the warehouse out of the site, you know, the warehouse doesn't have to be on the site, and you have, right away, more GMP facilities that you can access for utilities. The QC lab can also be moved off of the plant. It can be moved in the parking lot, you just get a new building. And here, again, you go with more GMP capacity. The pre-clinical robotics [inaudible] same thing, is currently in a GMP suite but doesn't have to be, because it's pre-clinical material, so there again, you can move it to the parking lot, in a new building.

So, if you think about the manufacturing strategy of Moderna, know that the big investment, we think it's a strategic investment, we cannot deliver on the mission of the company or the pipeline without Norwood. But we really need Norwood so that it becomes the central node for us, that it there for very long term, so that we do not have to invest CAPEX in the years to come at the high level, will not be the commercial plant until the product is approved. That would be way too risky.

Hartaj Singh -- Oppenheimer and Company -- Analyst

Great, thank you, Stéphane, that's great.

Operator

Our next question comes from Alex Shanahan of Bank of America Merrill Lynch. Your line is open.

Alex Shanahan -- Bank of America Merrill Lynch -- Analyst

Hey, Guys, thanks for taking my questions, and congrats on the progress. I just had a couple. So, maybe first on the hMPV/PIV3 combination vaccine, do you have a sense of the sort of data we'll likely see in October, and will we see data outside of antibody titer comparisons? And is the Phase 1b toddler study necessary, as per your conversations with the FDA, before you begin a phase three? And then, I have one more.

Tal Zaks -- Chief Medical Officer

Thanks, Alex, it's Tal. Yeah, so in October, we'll present the totality of the data as we have it, so you'll see the antibody titers, you'll see the safety, you'll see what you typically see when we describe the totality of the study. And I believe that's been accepted to ID week.

In terms of the seropositive toddlers, yes, I think that is consistent with the development that one would expect, and that the agency concurs. In terms of the next step in the development path here. So, ultimately, remember that they target population here is infants, so there's a pretty structured and rigorous way by which you work your way down into that population. Given the sensitivity to the pediatric population, we wanted to make sure that we've got clarity from the agency in terms of designing that study, and that's why we put in the press release, and we didn't discuss that interaction.

Alex Shanahan -- Bank of America Merrill Lynch -- Analyst

Right, right, I understand that's a sensitive patient population. And then, shifting gears to your KRAS vaccine, 5671, we've seen data from Amgen and others that are pretty encouraging on G12C, although it seems, you know, maybe there's a subgroup that requires additional combination therapies. So, I was just curious, on the KRAS vaccine, what your thoughts are for it as monotherapy, and also in terms of combination with checkpoint inhibitors. Thanks.

Tal Zaks -- Chief Medical Officer

Yeah, so I'll give you two versions of the answer, one on the science and one as a drug developer. On the science, unquestionably, I would want to combine these as early as possible, because we think there's orthogonal benefit, as I described previously, and one would expect they would get combined with checkpoint inhibitors in addition. You know, as a drug developer, you want to get confidence first that each individual has merit on its own, before you go into the combination. I think for us it's critical to demonstrate that the cancer vaccine is such, in combination with the PD1 inhibitor, can actually mediate responses. I think, once we get to that stage, we will obviously have a keen interest in pursuing the right combinations with the inhibitors, depending on where they are at that point in time. Alex, did that answer your question?

Alex Shanahan -- Bank of America Merrill Lynch -- Analyst

Yes, that's great, thank you.

Operator

There are no further questions. I'd like to turn the call back over to Stéphane Bancel for the closing remarks.

Stéphane Bancel -- Chief Executive Officer

Thank you for joining us today, and for your questions. We look forward to seeing you during our upcoming, third annual R&D day in New York City. This meeting will be held during the morning of September 12th. Have a wonderful day. Thank you.

Operator

Ladies and Gentlemen, thank you for participating in today's conference. This does conclude the program, and you may all disconnect. Everyone, have a great day.

Duration: 55 minutes

Call participants:

Lavina Talukdar -- Head of Investor Relations

Stéphane Bancel -- Chief Executive Officer

Tal Zaks -- Chief Medical Officer

Lorence Kim -- Chief Financial Officer

Salveen Richter -- Goldman Sachs -- Analyst

Matthew Harrison -- Morgan Stanley -- Analyst

Ted Tenthoff -- Piper Jaffray -- Analyst

Stephen Hoge -- President

Hartaj Singh -- Oppenheimer and Company -- Analyst

Alex Shanahan -- Bank of America Merrill Lynch -- Analyst

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