Barclay A. Phillips - Chief Financial Officer, Principal Accounting Officer, Senior Vice President and Treasurer Stanley C. Erck - Chief Executive Officer, President, Director and Member of Finance Committee Gregory M. Glenn - Senior Vice President of Research and Development.

William Tanner - FBR Capital Markets & Co., Research Division Edward A. Tenthoff - Piper Jaffray Companies, Research Division Gregory R. Wade - Wedbush Securities Inc., Research Division Kevin DeGeeter - Ladenburg Thalmann & Co. Inc., Research Division Vernon T. Bernardino - MLV & Co LLC, Research Division.

Good day, ladies and gentlemen, and welcome to the Novavax Q1 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded. I would now like to turn the call over to Buck Phillips, Chief Financial Officer. You may begin..

Thank you, and good afternoon, everyone. This is Buck Phillips, Chief Financial Officer of Novavax, and I would like to thank everyone for joining today's call to discuss our first quarter 2014 financial results.

Today's earnings release is currently available on our website at novavax.com and an audio archive of this conference call will be available on our website later this evening. Joining me on today's conference call is Novavax's President and CEO, Stan Erck; and Novavax's Senior Vice President of Research and Development, Dr.

Greg Glenn; as well as some other members of our executive team.

Before we begin our prepared remarks, I need to remind you that we will be making forward-looking statements during this teleconference that could include financial, clinical or commercial projections, statements relating to the future financial or business performance, conditions or strategies or other financial and business-related matters, including expectations regarding revenue, operating expense, cash usage and clinical developments, as well as anticipated milestones, all of these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act.

Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which may change over time. I will now turn the call over to Stan Erck, President and CEO..

Thanks, Buck, and good afternoon, everyone. We're now 4 months into 2014, and I'm very pleased to tell you that we've already achieved a number of our key corporate objectives for this year. We've also delivered on a number of other important achievements that go beyond our earlier guidance, which I will discuss with you this afternoon.

Arguably, our most important announcement of the year has been the top line data from the Phase II dose confirmation clinical trial of our respiratory syncytial virus, or RSV, vaccine candidate in 720 women of childbearing age.

Given the importance of that data, I'd like to ask Greg Glenn to start our conference call today with an overview of this important clinical trial and key top line data, as well as a brief overview of the next steps in our RSV maternal immunization development plan.

When Greg finishes, I will speak to the other corporate highlights and achievements during the quarter, as well as key anticipated events through the end of the year before handing the call to Buck Phillips, who will go over the financials. We'll then open the line to take any questions you may have.

And Greg, let me turn the call over to you to discuss our recent RSV trial..

Thanks, Stan, and good afternoon. On April 28, we announced the top line data from our dose confirmatory Phase II clinical trial in 720 women of childbearing age.

The study was a randomized, blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of multiple formulations of our RSV F-protein nanoparticle vaccine that was adjuvanted with aluminum phosphate.

The study enrolled 720 women between ages 18 and 35 who received either 1 or 2 iron injections, featuring 2 different dose levels of antigen with a range of doses -- of our aluminum adjuvant. The data discussed today relate to the 91-day period following first immunization.

Highlights include the RSV F vaccine candidate was well tolerated with no vaccine-related serious adverse events. The safety profile was very consistent with our prior studies. There are significant increases in the RSV anti-F antibody levels. But observed across all doses in all formulations, again, very consistent with our previous studies.

The highest immune responses were observed with a single dose of vaccine combined with the lowest dose of aluminum adjuvant. The clear increases were observed in both RSV-A and RSV-B neutralizing antibodies, again, across all doses of the formulation.

The increases in neutralizing antibodies were strong, the strongest in women entering the study with the lowest baseline levels, again similar to our previous observations.

What stands out is the placebo 120-microgram antigen dose generated peak palivizumab-like antibodies in approximately 400-microgram per ml, the highest level seen in any study to date. The vaccine-induced palivizumab-like antibodies demonstrated, again, very strong concordance with the anti-RSV-F IgG antibody responses.

When we looked at the kinetic analysis of the antibody responses, they showed rapid increases in the antibody levels in all vaccine formulations. The single 120-microgram dose -- antigen dose, again, generated peak antibodies to both RSV F, as measured by RSV F and the palivizumab-like antibodies at 14 days after immunization.

And these high levels were sustained through the 91-day observation period. So to say the least, we are highly encouraged by this data, the safety and immunogenicity again was observed to be very consistent with previous experience.

We delivered improved immunogenicity in a 1-dose regimen, which could improve patient convenience, vaccine uptake and compliance. And this data, we hope, will support the first maternal immunization study planned for the fourth quarter of 2014.

We have requested a Type C meeting with the FDA this summer to discuss our application to proceed with the study in pregnant women. And we do expect in the near future to present the entire data set in some detail at an appropriate scientific forum in the future.

Before moving on, I want to highlight and acknowledge that the study was conducted in collaboration with PATH, a nonprofit international health organization that "is driving transformative innovation to save lives." PATH provides both valuable technical advisory and financial support for this maternal immunization vaccine development program, which we both believe is transformative and could save lives of many young infants in the future.

With respect to the coming years, we've indicated before, we're proposing that the next clinical trial be conducted with pregnant women immunized with the RSV F-protein vaccine in the third trimester.

This would allow us to confirm the safety of the vaccine in both women and the infant, as well as to confirm that the antibodies generated by the vaccine are transmitted transplacentally. The data generated from this coming trial should provide the basis for moving the program into efficacy evaluations.

I should add that the data generated in this late clinical trial, as well as all the preceding trials are informative and encouraging as we move towards extending the testing of our vaccine to other populations, including the pediatric and combination vaccines. So with that, I'll turn it back -- the call back over to Stan..

1 in young adults, 1 in the elderly and 2 in women of childbearing age. All these trials have consistently demonstrated a clean safety profile combined with a very robust immune response. For RSV, over the next 12 months, as Greg mentioned, we plan to initiate our first trial in pregnant women to demonstrate transfer of antibodies to newborns.

We also expect to initiate our first trial in the pediatric population in an effort to develop a vaccine to protect kids from 6 months to 6 years of age. And finally, we expect to initiate our first trial for a combination respiratory vaccine candidate against both RSV and seasonal influenza, what we refer to as a pentavalent respiratory vaccine.

Switching over to influenza. As discussed on our last call, we've initiated a Phase I/II clinical trial of our H7N9 avian influenza VLP vaccine candidate and our Matrix-M adjuvant technology. This trial enrolled 610 healthy subjects to evaluate safety and immunogenicity responses to the vaccine with an adjuvant.

This trial is evaluating 3 different dose levels of the antigen and 2 dose levels with the Matrix-M management. We continue to expect the top line safety of the immunogenicity data will be reported in the fourth quarter of this year.

We believe this trial will lead to a dose confirmation trial in healthy adults, followed by a Phase III immunogenicity trial. Moving on to our Middle East respiratory syndrome coronavirus or MERS program. Last week, we announced published data in the journal Vaccine.

This data demonstrated that our MERS vaccine candidate blocked infection in laboratory studies. As many of you probably know, this emerging biothreat has been gaining momentum in the Middle East. Just this week, the first case of MERS was reported here in the U.S., proving the potential of these viruses to move quickly around the globe.

The current unofficial overall totals are 507 total cases and 142 deaths. We will obviously continue to monitor the MERS situation and keep you posted as to our development plans, and I want to underscore that MERS is yet another example of how Novavax technology can be rapidly and effectively utilized to address emerging virus scenarios.

So far in 2014, we have also demonstrated continuing commitment to our alliances. Our influenza contract with HHS BARDA, along with its access to $97 million in funding was extended beyond the original termination date of February 2014.

We also announced the continuation of our RSV maternal immunization partnership with PATH that Greg mentioned earlier. And both of these alliances bring valuable development resources in sight, experience and non-dilutive sources of capital to fund our lead programs.

And finally, we continue to strengthen our management team to meet the challenges and deliver on promises of our vaccine technologies. On the last call, I mentioned the addition of John Trizzino as Senior Vice President, Commercial Operations, who will be responsible for the planning and execution of our product launches for our flu and RSV vaccines.

We recently announced the hiring of Dr. Cindy Oliver to the position of Senior Vice President, Process Development Operations. Dr. Oliver will be responsible for all process development activities with a specific focus on the company's RSV F-protein nanoparticle, seasonal influenza and pandemic influenza vaccine candidates.

Previously, Cindy served as Vice President in Process Biochemistry and Formulation Sciences at Medimmune and before that, she had similar responsibilities at Merck. Yesterday, we announced the appointment of Sven Andréasson to the position of Senior Vice President, Corporate Development.

Sven brings a long history of experience in the vaccine and pharmaceutical industry to Novavax. And Sven will help us evaluate opportunities outside the company that complement our current platform. With that, I'll turn the call over to Buck to review our first quarter 2014 financial results..

Thanks, Stan. Before I continue, I must note that the financials I'll be discussing here reflect the consolidated results inclusive of our July 13 acquisition of Isconova AB, now Novavax AB. For the first quarter of 2014, we reported a net loss of $13.8 million or $0.07 per share.

This compares to net loss of $10 million, or again, $0.07 per share for the first quarter in 2013. Novavax had revenue in the first quarter of '14 of $7.5 million as compared to $3.8 million for the same period in 2013. The increase was primarily due to a higher level of activity associated with the company's U.S.

Phase I/II clinical trial of our H7N9 vaccine candidate with our adjuvant Matrix-M, as well as preliminary manufacturing work for our planned Phase II seasonal influenza trial and revenues under our PATH contract in support of the company's Phase II clinical trial in women of childbearing age.

The cost of government contracts increased to $3.0 million in the fourth quarter of 2014 from $1.7 million in the same period in 2013.

This increase, again, is directly related to the increase in revenues under our contract with HHS BARDA for our Phase I/II H7N9 clinical trial and the preliminary manufacturing work for our planned Phase II seasonal influenza clinical trial.

Research and development expenses increased to $14.5 million in the first quarter of 2014 compared to $9.3 million for the same period in 2013. This result primarily is -- from higher employee-related costs tied to continued growth in the support of the RSV and influenza vaccine programs, as well as the inclusion of Novavax AB R&D-related expenses.

And finally, general and administrative expenses increased to $4.3 million in the first quarter of '14 compared to $2.9 million in the same period of 2013, resulting primarily from the inclusion of Novavax AB expenses, higher professional fees and employee-related costs.

As of March 31, 2014, the company had $12.8 million in cash, cash equivalents and investments compared to $133.1 million as of December 31, 2013.

The increase in cash usage from prior year is primarily due to the ongoing RSV Phase II clinical trial that Greg discussed, as well as higher employee-related costs and the timing of customer and vendor payments. We expect our quarterly cash usage to be considerably lower over the foreseeable future.

With that, I'll close my comments and turn the call back over to Stan..

Thanks, Buck. Thanks, Greg. So let's open it up to the operator for our Q&A..

[Operator Instructions] Our first question comes from Bill Tanner of FBR Capital Markets..

Got a few of them. Maybe the first one for Greg, just in terms of the pediatric RSV vaccine studies.

What kind of learnings from? What's been done, I guess, with the clinical trials thus far that can be applied to the pediatric studies? And I guess, what I mean is, just in terms of the adjuvant that needs to be used in the dose, and maybe just your thoughts on the extrapolate ability of the safety and potentially efficacy for the younger population of -- patient population?.

Yes, that's a good question. So to date, we have now experienced no withdrawals on subjects using our RSV F-antigen with or without alum in different doses, and those provide tremendous menu for us to select what might be appropriate for the pediatric population.

As you know, we are considering the 6-month to 6-year period for active immunization, and our target product profile at this point is the seasonal -- annual seasonal vaccine.

And based on what we've seen, and this, of course, is quite different from the term immunization, in that this would be an active immunization where the subject who received the vaccine will have ongoing antibodies being made versus maternal immunization.

So that being said, we would go into the pediatric trial with a fairly narrow set of questions that might relate to whether or not we'd like to use aluminum phosphate in 1 or 2 doses. And I think we also will restrict ourselves to an older age group, where we know that they have some previous experience with the virus called seropositive population.

So those will be the sort of, I think, going forward questions we would ask. So these are -- these responses were seen in these last, actually all 4 trials, but in particular in the healthy adults, where we have a lot of comparative data have been very consistent in terms of the safety and immunogenicity.

And that's -- and of course, induction of what we would consider functional immunity. So we are able to go into a pediatric trial with a lot of confidence in our vaccine, and looking for the kind of responses we think are going to be protective as we move towards efficacy..

And then to what extent do you think the FDA is going to have some concern about safety, given the track record for an active vaccine in the pediatric setting? Is that something that because it's a particle -- the sub-unit particle vaccine should be different then from, I guess, it was an attenuated virus vaccine then?.

Yes, just to review that experience in the 1960s, there's a whole virus that was formulated and activated and put on aluminum hydroxide. And in that trial, they had observed disease exacerbation in the vaccines that was greater, significantly greater than the placebo. So that experience was observed in children 18 months and under.

They had, after induction of the vaccine, they had no neutralizing antibodies, no functional fusion inhibition antibodies.

It's quite clear that -- so that to reproduce that scenario, many groups have relied on the cause of that model, where you can immunize with that vaccine and, in fact, we have access to the original anti-vaccine, create a data set that reflects what we've seen in children that had this outcome and ensure that your vaccine is highly differentiated in terms of functional antibodies.

And that, by the away, that data is on our website in the portal presentation under Dr. Smith's presentation in RSV. So you can actually look at the primary data on that. So we have to provide, I think, confidence that our vaccine will perform quite differently, which we are very certain of.

And then take important steps to ameliorate that of the safety consideration. And so we will propose to go into the older pediatric population that by definition has had some experience with the RSV virus and they're, therefore, called seropositive subjects.

And I think the general consensus is that population is not a risk population for that phenomena. So that's where we'll start and we'll develop a plan going forward based on the data we see. But the safety -- of course, the safety would be a preliminary consideration.

We think that that's a very low risk setting and our key opinion leaders agree with us. So that will be the setting where one would begin to evaluate the pediatric vaccine..

And then maybe -- and you mentioned this -- don't know if it's for you or for Greg again. Just on the H7N9. Just thinking about the path forward, I think that you'll have the data readout. It sounded like you might do some dose finding then go into a Phase III.

I'm just trying to understand the scope of the additional work that needs to be done because I mean, obviously, it seems like it's going to be a smaller trial, then one would think if -- there's not really an efficacy endpoint per se..

I think the end point there is the immunogenicity. And as you'd probably -- if you recall from our first trial, we had very good immunogenicity. I would point out, if you look around the landscape, our data is -- stands out as being very good still to this date. So we expect to reproduce that with the Matrix-M.

That would lead to dose confirmation and the Phase III trial then will be done and licensed based on the immunogenicity of the vaccine itself. And we would probably use as guidance, the sero criteria that relate to seroconversion and seroprotection.

But at this point, we just -- we haven't really laid out specifically what that would be, but we certainly expect, of course, to have this vaccine licensed just on the immunogenicity of the vaccine..

Okay. And then maybe just one more, if I could squeeze it in. Just in terms of -- Henry Jackson is requesting folks on the energy and commerce committee maybe hold a hearing on MERS.

Any thoughts there as to what the outcome could be? I mean is there anything or do you think there's really going to be a takeaway from it? Or is it may be just the legislators looking like they're busy?.

I don't think I can actually comment on that. I don't know the answer to that question. Yes, we're getting -- there's a lot of interest -- we're starting to get inbounds from a variety of different sources, all the way to the Middle East and so not clear what the direction is going to be, right.

Now there's been all of these surge in activity has been in the last -- just in the last few weeks. And so it's a clear problem. We have a potential solution, and we were early enough on this to actually have publish data on it, so we'll see..

Our next question comes from Ed Tenthoff of Piper Jaffray..

I apologize if this question has been asked, but congratulations on the RSV data. I think that was very informative in terms of dose to take forward and the trial design.

Can you tell us a little bit more about the plans for the maternal immunization, the pediatrics and the potential influenza combo study for the RSV vaccine?.

Yes, so this is Greg here. So thanks for the question, Ted. So the maternal immunization, as we mentioned, we expect to have a meeting with the FDA, provide them with a data package on the product, the clinical data, et cetera and we provided them our draft protocol, what we expect to do in the fall.

And assuming that we agree on the PATH forward, we expect to do a trial on pregnant women. It will be a relatively small trial. It'll be -- we propose 50 subjects, 25 placebo, 25 active, where we'll immunize in the third trimester. Based on the dose, we have determined on the study and we will follow the children through an RSV season.

So that will be the safety evaluation, safety in pregnancy for active immunization and safety of the children after having received the antibodies passively.

I think things that are -- would be really important highlights, I would say really landmark data for vaccinology will be to observe the induction of the antibodies we measure in mothers and their induction, their transmission transplacentally to infants.

And as you know, after its physiologic mechanism with other vaccines, we see very robust transmission, certainly, antibodies at the level of the mother until we'd expect to see the palivizumab-like antibodies will appear in the infant.

And I think that will be a very important end, I would say, landmark finding in vaccinology to be able to create this type of antibody activity in infants.

If it is on the order of the level of antibodies we saw in this trial, which I will just point out that our vaccine has performed very consistently, that we would be transferring antibodies in the order of 400 micrograms per ml to infants. I think that would be really very interesting and important finding in that trial.

And then, we expect to do a limited -- in kinetics to watch the decay of antibodies in infants, so we do some aluminum sampling at the sero and hopefully describe [indiscernible], and therefore, determine to what degree you might expect the protection to last. How long through infancy. So that will be a very important trial establishing the safety.

I would say just as an side, there was a previous F-protein use in pregnant women. So from a risk standpoint in this population, we won't be doing something new. But this will be a vaccine where it's a recombinant protein [indiscernible] palivizumab-like antibodies.

Assuming that, that trial goes forward and we observe what we expect to observe the following year, then we would go on to a larger trial, where we'd be exploring the efficacy of the vaccine in infants in third trimester immunization and looking for the reduction of medically attenuated RSV disease, as proven by PCR in a larger population.

So that's sort of, I think, the horizon in which we're discussing in terms of maternal immunization with the RSV F vaccine.

So with respect to the combination vaccine, we expect to take the current quadrivalent vaccine that we're manufacturing and bedside mix that with the RSV F vaccine and there really will be a safety and immunogenicity trial in healthy adults and elderly and we expect that to be a relatively small trial.

But since we know a lot about the immune response, we think that the RSV F immune response we measure and neutralizing antibodies with palivizumab, as well as the HAI titers from the flu, all these are meaningful measures of immunogenicity that can be associated with protection. We think the immunogenicity trial will be very informative.

And again, we expect to see the -- sort of antibody levels we've seen in our previous trial for RSV F and our flu vaccine. So then this exercise in women of childbearing age is very informative. It really helps guide our thinking on the combination vaccine and, as we mentioned earlier, on what we would do in pediatrics.

So it's a tremendous data set, both safety and immunogenicity that gives us guidance on formulation and dosing choices..

Our next question comes from Greg Wade of Wedbush..

Greg, can you just remind us what vaccinations women get in their third trimester? And do you anticipate that the women that are planned to be enrolled in this study will get all of those as well as the RSV vaccine? Or will you be doing some mixture of the other vaccines they may choose to get with -- and then as well in the RSV? And then, what are your thoughts on the pediatric vaccine? Is the company primarily thinking they will drive to a product, which is a combo flu RSV with no adjuvant? Or do you think that an adjuvanted annual RSV vaccine is acceptable for little kids?.

So on maternal plans, we will adhere to standard of care. So women will receive the vaccines that they should get in the third trimester. So just to cover, I think, there are 3 vaccines that are most prominent and given to pregnant women.

Of course, you know globally and we do have a global interest in our vaccine, tetanus vaccine is given to all women of childbearing age, all pregnant women, to prevent neonatal tetanus. And as you would recall, that's been a fantastic public health success with 92% reduction of what's a very bad disease, neonatal tetanus and globally.

So in the U.S, the influenza vaccine is given and the seasonal vaccine regardless of the gestational age, so that will include third trimester women. But of course, that's given in the fall, in advance of the influenza season.

And then all women will receive the pertussis vaccine, the whooping cough vaccine, and generally speaking that's recommended in the third trimester. And that again, that would be standard of care. So these are -- this is again from, I think, from a risk standpoint, we have a major advance in the biology of RSV with our findings.

But then in terms of execution and practice, it's nice not to be taking giant new strides in terms of our immunization practice, our maternal immunization is a practice, it's accepted, it's standard of care and I think it's very important that those precedents have been established.

The pertussis vaccine, as you know, is recommended by the ACIP and universally, immunization of flu has been around for some time and actually, what has been interesting in context of flu, it's been shown to have very good effects on the mother, on the outcomes of pregnancy and the outcomes in infant influenza.

So we're following a pretty well-tread pathway there, albeit with a novel vaccine.

And I forgot, you asked me about pediatrics?.

Yes, in the endgame in the 6 months to 6 years to get a combo flu RSV so that the children can avoid exposure to the adjuvant, which both hurts and....

Yes, so we haven't made that decision yet. That's one of the things we will be testing. Aluminum -- the alum adjuvant we use aluminum phosphate, commonly used in many pediatric vaccines.

One of the outcomes that we had in this trial, whenever you use something like aluminum phosphate, you need to show that you're using the minimum dose required to get the desired response. And so we were able, I think, to fulfill that obligation and these are very little doses.

But we really haven't made a final formulation decision, nor have we, at this point, made a commitment to take a combination vaccine in pediatrics. We do see ourselves as wanting to be an RSV franchisee -- a vaccine franchise, and we think our vaccine is very promising.

We have data that seem to be breakthrough and we're anxious to provide this modality to all the populations at risk for RSV..

Okay, and I just have one follow-up.

Stan, what would the potential MERS-CoV medical countermeasure look like?.

From our point of view, it could be a vaccine that could be used actually the medical countermeasure could be to prevent -- to vaccinate animals would be one way. The other would be a human vaccine, and those are the 2 that are currently on our table right now, same vaccine.

Is that the answer to your question?.

Yes.

Do you believe that a mass vaccination in people, would be potentially acceptable based upon a limited number of hosts that have been infected?.

Yes, and that actually depends on which way or which direction the disease goes. And then it might be in the geographic area..

Our next question comes from Kevin DeGeeter of Ladenburg Thalmann..

Most of them have been answered, but yes I just want a little bit about business development.

You did announce the appointment of the new Head of Corporate Development this week and maybe you can talk a little bit about priorities, particularly in light of the M&A activity that's going on at big pharma and how that sort of reshaped the potential partner and landscape for a program like RSV and potentially the flu, for that matter.

So I guess, the 2 questions here, how does that external change in the landscape factor into your thinking on business development and what are the priorities for the new Head of Corporate Development that you announced this week?.

Thanks. Good question. So let me go back to the -- what I consider business development as opposed to corporate development. It's commonly referred to as business development as getting outside partners to help support your program, the typical large pharma biotech company.

And we remain committed to the idea that bringing in large pharma partners at this stage is not to our benefit or our investor's benefit for a couple of reasons.

One is we think we've done a really good job of developing the RSV vaccine candidate into multiple indications, elderly, kids and/or at least heading toward pediatrics and maternal immunization. And we don't think that this would've been done as quickly under the auspices of the usual coordination you have to do with a big pharma company.

And we think that's true for the foreseeable future. So we lead in this product and we lead the industry in this product and we want to maintain that lead for the -- through to licensure. And so we're not interested in partnering.

And then of course, the economics, we want to maintain the economics for Nova, 100% of the economics for Novavax for the time being. We think it's a really important vaccine, perhaps, one of the -- perhaps, the biggest vaccine -- new vaccine to be introduced in the foreseeable future.

And we are confident that the data that we've shown gives a lot of confidence that the vaccine will be protected. So we think we've de-risked the program to a degree and we've got to get into Phase III and beyond. So that's the rationale between our not partnering.

The other side of the question, the corporate development issue is we've now got a company that's grown to where we're getting into Phase II and Phase III trials.

We've got to start thinking commercially about how to introduce these products, what other companies or products might be compatible with our future developments, so we brought someone on to explore all of the opportunities external to the company that might be compatible.

And that's, in part, because we have a greater ability to think of bringing -- doing M&A type activities whether for licensing and/or products or like we did with the Isconova last year, which is to bring important technologies to our -- into our company.

So that's the role of the corporate development is to explore outside opportunities that could be fit with what we're doing..

Our next question comes from Vernon Bernardino of MLV & Company..

You had mentioned a few of the details regarding your Type C meeting with FDA this summer and one of the things that I think you mentioned was providing a draft protocol.

I'm just wondering if you could share some of those details in the draft protocol?.

Well, I think the level of detail I can provide to you is that we expect to do 50 trials randomized placebo-controlled, with our vaccine, given the half and placebo to the other half. Usually, subjects in the third trimester.

We will have a cord blood draw and a Day 0 or day-of-birth draw from the mother, so we'd have a matched infant-mother sero care.

And we, as I mentioned, we will sample -- we expect to sample the infants in a limited basis to describe a half-life immune kinetics of the antibody response to the vaccine in the infants over approximately 4- to 6-month period.

And then, the key element of the safety will be to, of course, evaluate the vaccine safety as we have been in limited childbearings in the pregnant women and then to evaluate the safety of the presence of antibodies in infants from RSV-Cs.

And so they actual monitor for exposure to RSV and any respiratory illness would be crucial for presence of virus. I think that's kind of in a nutshell what I can describe of what we've said publicly..

And I think you had mentioned, you're also going to measure transmission of some amount to infants. What is the exact measure? I think Greg said something like....

Yes, that's a good question. So what we do is we take at the day of birth, you have a sero sample taken from your and the mother and the cord blood is associated with the infants' side of circulation, and it comes out with the placenta.

So commonly, people collect cord blood for banking, for stem cell, et cetera, we'll collect a sample of that blood and so we can take the mother's sero and the cord blood, which is the baby's blood, and as I look into the presence of the anti-F IgG, the palivizumab-like antibodies and the neutralizing antibodies and see how closely there's a match between the mother's levels, which should be elevated due to the vaccine, and then what's in the baby's blood, which would be due to transfer -- active transport to the placenta from the mother's blood to the baby's sero.

And of course, we will have a control group, so you should have mothers who have very little or no palivizumab antibodies, for example, until the babies will not have -- and so we'll be able to control and determine the level of transmission. And that -- this is a phenomena.

It's very well known in many antibodies that have been described, showing that they are transferred from the mother to the baby by this mechanism and it's a physiologic mechanism for the protection of infants.

They, basically, are given the full complement of the mother's infectious disease experience that manifest itself as antibodies to protect them from the first several months of life, so -- until the baby develops its own active immunity through exposure to pathogens.

So a lot is known about this phenomena, trans-placental transfer and we would expect that the antibody levels that we induce in the vaccine and the mother's will show up at least as high as the mother as well as in the infant. So there should be a relative match with those antibody titers.

And as I mentioned, we see very high levels of palivizumab-like antibodies in the mothers, and it would be very encouraging and I think de-risking for the program to see those surge in levels of antibodies showing up in the infants..

I appreciate that detail. It sounds like you've got a lot of things figured out already for the study once you get it started. Regarding the pentavalent vaccine. Just wondering if you could provide, I guess, something about a time line here.

What status and what work needs to be done? You had mentioned that you'll be starting late 2014?.

That's about right time frame that's about the right time frame. So we'll -- it'll be simply a safety and immunogenicity study. So it won't be a long study in terms of the, provides some top line data on the immunogenicity. And we will measure -- there's going to be 5 components.

There are 4, if you recall, we have a quadrivalent flu vaccine, which has 2 B strains and 2 A strains. And we'll measure the immune response to each of those strains. And then, we'll measure the antibody responses to our RSV vaccine as we have in the past, if you're looking at anti-F IgG Palivizumab levels to neutralize the antibody.

And I think the sort of the critical question there would be to see how those immune responses interact.

In other words, is there some diminution in the responses in the presence of the combined vaccine? Or is there some enhancement? As we've seen in the animal studies, where when we add flu and RSV F together, the RSV class antibodies responses is augmented by the presence of flu vaccine..

And so regarding the timing there, is it because you also want to start late this year to be in time with the regular flu season?.

Well, we have -- the beauty of having 2 hemispheres and 2 seasons then, it's possible that we'll go to the Southern Hemisphere to not complicate the interpretation trial by being out of a flu season. So we have that option, as we did for H7N9. We did do that trial in the Southern Hemisphere in Australia..

Yes, so -- this is Stan, I'll chip in. So this is just the timing of, as Greg said, we've got options, so we don't have to wait past the flu season, we can pick. But this is availability product.

We're now scaling our production of quadrivalent flu vaccine because we're planning on starting that, what we call, what we refer to as the 206 trial, which is our -- which we hope to be our final dose confirmation for quadrivalent flu vaccine trial.

So I have material from that, as well as our RSV production, so we'll have the ability to go into that clinical trial in the fall -- in the, let's say, in late fall..

We have a follow-up question from Bill Tanner of FBR Capital Markets..

Greg, just had a question on the pentavalent, what you would actually need to show in the registration study. I mean, I'm assuming that you wouldn't need to show that there's a difference in subjects that are dual-infected versus not depending on the vaccine as at -- sort of explain to me sort of how that would work then..

Well, we haven't really laid this out first in a couple of possibilities that we will show efficacy in the separate vaccines we sold, which is about the traditional way for combining vaccine. So when you get a -- when your child gets a combination vaccine, those individual components have been shown to work first.

They establish the immune correlates and then you combine them. So that's a possible route for a combination vaccine, where we show the efficacy of the separate components that will be the seasonal flu. As you know, BARDA is funding that. We plan on being in seasonal flu Phase III trial within this coming year.

And then where would that data come from RSV, I think that's yet to be determined. But we have efficacy and that's associated with a certain level of immunity, that would make the task of getting a license combination vaccine simpler, in our view, and it might be possible to do that just based on immunogenicity..

And so you would need to show that what you're going to be doing is that there is an attenuated immune response when you combine the 2?.

Right, right. That's exactly right. That's always the key task of the vaccines that have been combined, to make sure they don't interact in a negative way when you try to administer them..

I'm showing no further questions. At this time, I'd like to turn the call back over to Stan Erck for any closing remarks..

Okay, once again, thanks for everybody participating. We look forward to reporting to you again in a quarter and we've got, as you can tell from the call, we've got a lot of activities going on throughout the rest of the year. Thanks..

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