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Novavax Inc  (NVAX)
Q1 2019 Earnings Call
May. 02, 2019, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good day, ladies and gentlemen, and welcome to The Novavax First Quarter 2019 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct the question-and-answer session and instructions will be given at that time. (Operator Instructions) As a reminder, this conference is being recorded.

I would now like to turn the conference over to Erika Trahan, Senior Manager, Investor Relations and Public Relations. You may begin.

Erika Trahan -- Senior Manager, Investor Relations and Public Relations

Thank you, operator. Good afternoon. I would like to thank everyone for joining today's call to discuss First Quarter 2019 Operational Highlights and Financial Results. A press release of our earnings is currently available on our website at novavax.com, and an audio archive of this conference call will be available on our website later today.

Joining me on today's call are Stan Erck, President and CEO of Novavax; and John Trizzino, Chief Business Officer and Chief Financial Officer. Dr. Gregory Glenn, our President of Research and Development, will also be available for the Q&A portion of the call.

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 future financial or business performance, conditions or strategies and other financial and business-related matters, including expectations regarding revenue, operating expenses, cash usage and clinical development and anticipated milestones 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 change over time.

I'll now turn it over to Stan to begin today's call.

Stanley C. Erck -- President and Chief Executive Officer

Thanks Erika. In the first quarter of this year, we reported data from key clinical trials of our two late stage programs. Novavax maternal immunization trial, we reported the first ever efficacy data in base three trial for RSV. Said this before, but it's worth repeating. We accomplish this after 16 years of development efforts by the entire vaccine industry.

Additionally, earlier in the first quarter we demonstrated for the second time in consecutive clinical trials that Nanoflu when compared to the best selling flu vaccine in the older adult market is a differentiated more broadly immunogenic flu vaccine. These are remarkable accomplishments and reflect the importance of the Novavax recombinant nanoparticle vaccine platform and the value of our dedicated development teams.

So let's talk about the challenges lying ahead of us, and what we're doing to address these challenges. The immediate future of both our RSV and flu programs rely on interactions with regulatory agencies, which have been and remains very good.

First, let's talk about Nanoflu. In a very large global market that tries for a better vaccine, we are now poised to bring a differentiated vaccine until pivotal Phase 3 trial. Since we announced results from the Phase 2 trial in January, we have been assembling all of our safety, immunogenicity, manufacturing data and preparing a briefing document to present to the FDA at an interface to meeting. We expect that the outcome of this meeting will be an agreed upon Phase 3 pivotal trial design that utilizes the accelerated approval pathway to support future licensure.

If we get the green light, then our Phase 3 trial design could be a straightforward as conducting a noninferiority immunogenicity clinical trial against a licensed comparator which is an efficient cost effective approach to getting our differentiated seasonal flu vaccine into the US market.

During the ResVax, it should be no surprise that our investors as well as our current potential partners have all been waiting for us to provide clarity on the pathway and timing for product licensure. That is exactly what we are focusing on. Let me emphasize that we have remained -- we remain optimistic that we have a Phase 3 package, including both safety and efficacy data that could support licensure.

We summarized our data at the World Vaccine Congress meetings last month and continue to believe we have achieved an important needed breakthrough for the field Pediatric Infections Diseases. The good news is that we are getting the attention of regulatory agencies globally. We have prepared and submitted briefing documents containing our data that provide these agencies with the full ResVax picture available today. We have now scheduled meetings in May and June in the United States. And four other countries with national regulatory agencies and additional scientific advisors and expect to come out of those meetings with a clearer picture of our options.

Given the high burden of disease from RSV in infants globally, combined with the data from the world's first Phase 3 efficacy trial with an RSV vaccine. We expect the discussions that we will have with regulators KOLs globally will have a very high profile. We will report on the outcome Leroy Hood's (ph) in the third quarter.

Although my comments have been brief, all of the regulatory and planning activities that we said we would do are in process. And we expect to have multiple investor communications later this quarter.

Now turn the call over to John to present the financial overview.

John J. Trizzino -- Senior Vice President, Chief Business Officer and Chief Financial Officer

Thank you, Stan. Today we announced financial results for the first quarter of 2019. A summary of our financial statements can also be found in today's press release. For the quarter, we reported a net loss of $43.2 million, or $0.11 per share, compared to a net loss of $46.4 million or $0.14 per share in the first quarter of 2018. The decrease in that loss was primarily due to decreased development activities of ResVax, partially offset by decreased revenue under the Bill & Melinda Gates Foundation or BMGF grant agreement.

Revenue in the quarter decreased 59% to $4 million compared to $9.7 million for the same period in 2018. The BMGF grant revenue is directly related to operate activities in the prepared trial, and so therefore this decrease in revenue is a result of completing enrollment of the prepared trial and the second quarter of 2018.

Related to our net loss for the quarter, R&D expenses decreased 20% to $35.5 million primarily due to decreased development activities, including lower clinical trial costs of ResVax. And G&A expenses were flat for the quarter at $8.7 million compared to the same period in 2018.

As of March 31, 2019, Novavax had $108.7 million in cash, cash equivalents, marketable securities and restricted cash. Net cash used in operating activities for the first quarter of 2019 was $50.6 million, compared to $66.1 million in the first quarter of 2018. While we typically don't offer guidance on cash usage, we expect our cash used in operating activities to decrease for the subsequent quarters of 2019, as compared to the first quarter of 2019. This is due to the timing of payments in the first quarter of 2019 as the prepare trial expenses wind down this year.

Lastly, we've added $55 million to our cash position in the first quarter from our ATM and expect that this will give us more room to evaluate our regulatory pathway for ResVax.

This concludes my financial review. I'll now turn the call back to Stan.

Stanley C. Erck -- President and Chief Executive Officer

Thanks, John. To reiterate, Novavax team remains focused on advancing ResVax and NanoFlu in 2019. We look forward to updating on our discussions with global regulatory agencies on pivotal licensure pathways from RSV, and the use of the accelerated approval pathway from licensure of NanoFlu in the US. I'd like to thank our shareholders for their continued support. We look forward to updating you on our progress both in this quarter and throughout the year. Operator?

Questions and Answers:

Operator

Thank you. (Operator Instructions) Our first question comes from Joel Beatty of Citi. Your line is now open.

Shawn Egan -- Citigroup -- Analyst

Hi. This is Shawn Egan on for Joel. Thank you for taking my questions. My first one. Which countries have you -- do you have regulatory meetings planned for Arab, US. But I missed, which other countries do you have those plans?

Stanley C. Erck -- President and Chief Executive Officer

Yeah. So right now we've got regulatory meetings in Germany, in the UK and Spain and Sweden.

Shawn Egan -- Citigroup -- Analyst

Great. And then I have two other questions. One on ResVax and one on NanoFlu. I'll start with the ResVax. A few but a little bit more time to kind of digest your data. As you're kind of putting together these briefing documents with the various agencies. And you think about the different markets in geographies that ResVax could potentially be approved. Are there different data points that are more or less important for the different geographies.

Stanley C. Erck -- President and Chief Executive Officer

Yeah, I think we've got Greg Glenn on the phone. I'm not quite sure -- how to answer the question. But go ahead, Greg.

Gregory M. Glenn -- President, Research and Development

Yeah, I think, I think, what we're after is generalizable ability of our data. So RSV is a global disease. It's both the temperate and tropical disease, so it's really as a universal issue in our case would be that the signal was offer efficacy would be generalized in last two (ph) days. We would attempt to get licensure.

And I think you asked a little bit about what we're emphasizing and I think what the -- in that context you look at the all cause effects they're really quite profound, and we have these effects that I think pediatricians would care about, that is to prevent severe hypoxemia hospitalization from any lower risk or track elements in infants, really important.

We are -- we have begun to work with the WHO and part of that dialogue is a pathway to giving broad approval for the rest of the world as well. So I think the point is that the data in our view is generalizable and that would be our case we make in the effects on the all cause severe respiratory outcomes is profound and we think that will drive a lot of the interest in vaccine.

Shawn Egan -- Citigroup -- Analyst

Understood. Thank you. And then for a Nanoflu, I believe in previous calls you've indicated that in the discussions you've had with the FDA that accelerated approval could potentially be available for Nanoflu. Can you discuss which criteria that were discussed that if not would make this pathway available?

Stanley C. Erck -- President and Chief Executive Officer

Greg, you want to or may I?

Gregory M. Glenn -- President, Research and Development

Yeah. Go ahead. Not maybe I can fill in and I didn't -- I, not sure I heard the full question.

Stanley C. Erck -- President and Chief Executive Officer

Yeah. So it is just what you want to -- you want to be non inferior to you compared to a licensed vaccine. The vaccine has already been licensed and shown efficacy. And there are corners of protection to try, to compare yourself to and you go head to head. You reached our four stage in your vaccine and you measure the immune response and we show that we are -- it's a term I hate, because I think we're better, but it's term is not inferior and so, and that allows you to -- it allows you to get a license vaccine and then you make a commitment with the FDA that post licensure as your marketing the product. You also commit to doing an efficacy trial. And so you have actual efficacy data down the road, but it's really accelerates the process of being able to sell the marketing product. It's nice to be able to do a clinical trial with a product on the market.

Gregory M. Glenn -- President, Research and Development

Yeah. We can refer you to the FDA guidance on accelerated approval soon there. So the actual mathematical criteria are based on the geometric mean tighter ratios and your conversion. And they have criteria and we can get you a copy of the FDA guidance with accelerated approval to become more familiar with that.

Shawn Egan -- Citigroup -- Analyst

Sure. That make sense. Maybe I can be a little bit more clear. Are there any criteria that had to be meet -- met in the Phase 2 studies in order for the Phase 3 program to be accelerated approval eligible.

Gregory M. Glenn -- President, Research and Development

Safety, of course, and there were no prespecified endpoints that had to be met to get a win there, so that is our view the data will both -- will support Phase 3 trial.

Stanley C. Erck -- President and Chief Executive Officer

So process right now Shawn. Okay. The process right now to be clear as we've asked for clarity on accelerated approval pathway. And we expect an answer to that very soon. And then we will file a -- in the Phase 2 data package which should get us a meeting of face-to-face meeting with the FDA in July. And that's the point at which we would reach agreement on the Phase 3 trial design. So that we could start in September or October.

Shawn Egan -- Citigroup -- Analyst

Perfect. Thank you so much.

Operator

Thank you. And our next question comes from Kevin DeGeeter of Oppenheimer. Your line is now open.

Kevin DeGeeter -- Oppenheimer & Co -- Analyst

Hi. Thanks a lot. Yeah, just a few more questions for me. With regards to how you think about communicating the outcome from these multiple regulatory discussions. Do you envision at least with regard to ResVax? Completing each of these regulatory discussions before providing an update with regard to SCA. Do you need to see the minutes before you want to provide some sort of feedback. I'm just wondering you provide -- get some granularity might help us look and how to think about the timelines?

Stanley C. Erck -- President and Chief Executive Officer

Kevin, I'm sure we will want this much granularity as possible and that depends on how we cut with the dialogue is in the meeting will. The meetings are all within -- the initial meetings are all within one month of each other. And so we'll be getting various different opinions, and we haven't decided whether we will -- we would announce one before we had the rest of them. But I think it maybe that will assemble data from the five and the trial five and the conversations, and say this is what we think. We're hearing and this is the pathway that we think will take to licensure. But it's not on return.

Kevin DeGeeter -- Oppenheimer & Co -- Analyst

And with regard -- with regard to bringing presentation stand, I guess, next week since Friday, pediatric infectious disease. In a high level, yes, we anticipate demonstrably different part of the data than we saw few weeks ago or will that cover a lot of comparable ground?

Stanley C. Erck -- President and Chief Executive Officer

I think I'm going to cover a lot of comparable ground. I mean, every week something new comes up, but I think you'll cover a lot of comparable ground that will focus on the efficacy that we received. The particular efficacy that we got for the more severe form to RSV than we were more important from a medical standpoint. And a couple thoughts on why there was an imbalance between the trial outcome, the US trial outcome and the rest of the world. So those are the types of things we'll cover. I don't think it's going to be startlingly different. We do have a little more time to present it to, you always get a little bit more data and so -- but not to say there won't be exciting presentation, Kevin.

Kevin DeGeeter -- Oppenheimer & Co -- Analyst

Sure. That will be great. Okay, perfect. And then just two more real quick ones if I may. First just a housekeeping item. Can you -- John, can you comment current share account?

John J. Trizzino -- Senior Vice President, Chief Business Officer and Chief Financial Officer

Covering outstanding shares?

Kevin DeGeeter -- Oppenheimer & Co -- Analyst

Yes, of course. That so we -- that kind of work made backwards turn to $55 million (ph) offered the ATM into an incremental share of insurance number.

John J. Trizzino -- Senior Vice President, Chief Business Officer and Chief Financial Officer

Yeah. So we had $55 million raised on 84 million shares. And so total now outstanding shares is 469.5 million shares.

Kevin DeGeeter -- Oppenheimer & Co -- Analyst

Perfect. And then just lastly, with regards to your very strong relationship with the Gates Foundation. How should we think about a timeline for a potential updated scope of ongoing work under that relationship. They continue to provide meaningful financial and non-financial support to the RSV program. I guess sort of under the early defined work plans sort of -- how, what sort of the duration of work will be completed and when or what might the criteria be to define a new or expanded work plan?

John J. Trizzino -- Senior Vice President, Chief Business Officer and Chief Financial Officer

Well, as I have said in the past and as you know, the Gates Foundation thinks that we have clinical trial data that fits their mission, that meets their needs. It's an infant mortality in low income countries, the vaccine works. So how to get a license, and so I think we are putting -- we're working with them, put our heads together to define what a pathway to licensure would be just for lower middle income countries such as we will get WHO pre qualification. And we're laying out that pathway now, and if it deems that is a reasonable pathway with a reasonable cost and a reasonable time point, that allows us to get the product into mothers -- pregnant mothers and a handful of years or less, then I think that we could expect that the foundation will push us to do that. And that's a good thing.

Kevin DeGeeter -- Oppenheimer & Co -- Analyst

Perfect. Thank you for taking my questions.

Operator

Thank you. And our next question comes from Michael Higgins from Ladenburg Thalmann. Your line is now open.

Michael Higgins -- Ladenburg Thalmann & Co -- Analyst

Thanks for taking my questions guys. Couple more on set back in the queue. First on Nanoflu. Should we still look for the 56 days, 180 days (ph) data this quarter. And when we do see that what are the most important things that you want to seen this longer term data versus what we've seen before.

Stanley C. Erck -- President and Chief Executive Officer

Greg, are you still with us?

Gregory M. Glenn -- President, Research and Development

Yeah. So what we've done with the day 56 here as look at the HAI responses which is by using two assays, the egg based assay that the FDA was guiding us on and of immunogenicity and the DOP which is an assay that uses recombinant proteins and we think reflect -- mostly reflects what happens in the nature and what we need to protect against and also we will confirm that with the use of micro neutralisation and that is another type of assay that is a functional assay.

So that data together, we think is going to be important and we -- to show that the responses are persisting. We're in the process of submitting abstracts to high end meetings and to present the data in fall.

So, I don't think at this point we're ready to go through that information. So that assays you'll see data from and again just to be clear though, generally speaking the accelerated approval would be based on May 28th, immunogenicity comparison like licensed competitor and that of course compares the geometric mean titer ratios and the zero conversions.

I think we mentioned earlier on the call that those criteria for success in those trials are outlined in the FDA accelerated approval guidance (inaudible) what's in there.

Michael Higgins -- Ladenburg Thalmann & Co -- Analyst

Okay. That's helpful. So it sounds like we'll see that data in this fall, is that fair?

Gregory M. Glenn -- President, Research and Development

Sounds about right. You know, we haven't announced the schedule of the meetings. But we are waiting (ph).

Michael Higgins -- Ladenburg Thalmann & Co -- Analyst

Okay. We're kind of losing you there, but have to have you on the phone nonetheless. And from the Phase 2, is it this fall we look for more information on how the NanoFlu looks against the commercial (inaudible) vaccine.

Gregory M. Glenn -- President, Research and Development

That's about right on standard. John, you want to chime in on the timing?

Michael Higgins -- Ladenburg Thalmann & Co -- Analyst

For the Phase 3?

John J. Trizzino -- Senior Vice President, Chief Business Officer and Chief Financial Officer

Yeah. So I think we're somewhere of --

Gregory M. Glenn -- President, Research and Development

No, no, Phase 2.

John J. Trizzino -- Senior Vice President, Chief Business Officer and Chief Financial Officer

Late September or early October.

Michael Higgins -- Ladenburg Thalmann & Co -- Analyst

And the conference it sounds like...

John J. Trizzino -- Senior Vice President, Chief Business Officer and Chief Financial Officer

No, that's start of the trial. No, so the (inaudible) trials. You vaccinate people on day zero. You draw blood, 28 days later. And then you run the asset, you collect and run the assets. So you won't get data until the first quarter.

Michael Higgins -- Ladenburg Thalmann & Co -- Analyst

Right. The data from the Phase 2 against the commercial (inaudible) flue vaccine.

John J. Trizzino -- Senior Vice President, Chief Business Officer and Chief Financial Officer

Oh sorry then.

Michael Higgins -- Ladenburg Thalmann & Co -- Analyst

Named EE (ph) That was a late to (multiple speakers). Yeah. Right, we're going to see some more information on how it looked against that commercial vaccine.

Stanley C. Erck -- President and Chief Executive Officer

Okay. I think we gave you the high level in our press release, Greg you're going to have -- you're going to have to.

Gregory M. Glenn -- President, Research and Development

Yeah, I just think it's worth submitting the abstracts and that's about the right time frame. I think September-October time frame for that information, we talked about in detail, we also feel that it's worthy of a high end publication.

You know, the timing of those submissions and acceptances are kind of hard to predict, but that's -- I think that's our plan. So abstracts for high end scientific conferences, submission of the data and you know we -- at this point I don't have a specific conference for which we have the -- we'll have the data at this point.

But it's good data, and I think we're very excited about the program. I think the fact that, we think that this can move into an accelerated approval is a sign of what we think of our data.

Michael Higgins -- Ladenburg Thalmann & Co -- Analyst

Right. Okay. All right. That's very helpful. It sounds like we'll have some news flow this summer on ResVax in the fall, it picks up again with NanoFlu. Just one last question or two here. Can you give us an update on cash runway? And then we'll ask a follow up after that.

Stanley C. Erck -- President and Chief Executive Officer

So Michael you know we don't give specific guidance I guess from where I think we have indicated in these industry -- formal script that we expect to see cash used in the business decrease over the coming quarters off of the $108 million of cash we have on hand today.

So I think $109 million. So I think that's about as much guidance as we intend to give at this point.

Michael Higgins -- Ladenburg Thalmann & Co -- Analyst

Okay, fair enough. And Stanley, I believe you've noted in your prepared remarks that you're expecting to have several investor communications this quarter, I assume that's on ResVax.

Stanley C. Erck -- President and Chief Executive Officer

I expect to have investor communications on both ResVax and Flu.

Michael Higgins -- Ladenburg Thalmann & Co -- Analyst

Okay. Very good. Thanks guys. I'll jump back in the queue.

Operator

Thank you. And our next question comes from Eric Joseph of JPMorgan. Your line is now open.

Turner -- J.P. Morgan -- Analyst

Hey, this is Turner on for Eric. Thanks for taking my question. So I just was curious on NanoFlu, it sounded like previously you get feedback from the FDA in the second quarter and maybe you got pushed back to the third quarter now.

So I was one, wondering is there any reason as to why. And then number two does that potentially impact the planned start of the study? And I suppose is there any importance to starting the study in the fall ahead of the flu season or if it's delayed, will that potentially be an impact of potential result?

Stanley C. Erck -- President and Chief Executive Officer

Yes, well if there were a delay it could impact the result, but I don't think there will be a delay. We -- I think we had said previously that we'll be filing the Phase 2 and Phase 2 package for the meeting there is a -- there is a statutory set of date that the FDA has -- have the meeting and I think we said it'll be in the June, July which covers over both quarters.

I think it's more likely that it'll be a July meeting. So the third quarter versus the second. So it's not a dramatic change and yes it is in plenty of time to allow us to execute the clinical trial in September, October time frame.

Turner -- J.P. Morgan -- Analyst

Okay. Great. Thank you.

Operator

Thank you. And our next question comes from George Zavoico of B. Riley FBR. Your line is now open.

George B. Zavoico -- B. Riley FBR -- Analyst

Hi, good afternoon and thanks for the update. Just following on from that last question was regarding to the FDA and ResVax and NanoFlu. Is that going to be one meeting where you talking about both vaccines, or you have to do separate meetings for one for ResVax and one for NanoFlu?

Gregory M. Glenn -- President, Research and Development

No, separate meetings.

George B. Zavoico -- B. Riley FBR -- Analyst

Okay. And with regard to NanoFlu, the non-inferiority does it have to be non-inferior for all four strains or not?

Gregory M. Glenn -- President, Research and Development

Yes, that's our expectation, and although I believe that there was a vaccine approved where three out of the four were not inferior and one was inferior and got licensed. So, (multiple speakers) there is...

George B. Zavoico -- B. Riley FBR -- Analyst

Okay. And with regard to the -- what you mentioned about the Bill & Melinda Gates Foundation, it implied that there might be a different path for registration in the low-to-middle income countries versus US and Europe and the wealthier Asian countries.

Is it possible that, that might happen that you might see this flu, the ResVax vaccine approved with the backing of BMGF earlier than in Europe, supposing you have to do a Phase 3?

Gregory M. Glenn -- President, Research and Development

We are on (inaudible) running in all countries high income and low level. And we want to see what we're going to get. And so we don't think it's a bad thing to introduce a product in large population markets. The price will be very different but with the backing of Gates and others, going there I think if nothing else it gets the product where it needs to be to save lives. And number two, I think it will demonstrate maybe help -- it may help push along in the high income countries that are reading the kind of the excellent work (ph). So I think there's no negative thing about going into a low middle income country particularly (multiple speakers)...

George B. Zavoico -- B. Riley FBR -- Analyst

I wasn't implying that, I agree with you completely, getting into market no matter where is a good thing. I'm just wondering if that scenario was a possibility in the -- the answer is yes. And with regarding the registration packages you're sending to the regulatory agencies, it sounds like pretty much you can just copy the same one to all of them and as you imply that there's not a whole lot of difference in what your -- in what message you're trying to get across regarding the efficacy of the vaccine.

But the one difference may be that in the EU for example you didn't take the alpha hit there for the informational analysis. So as far as the EU is concerned it's a successful Prepare Trial. Is that correct and are you just going to go straight to registration, possibly go straight to registration there without having to talk about another Phase 3 trial?

Gregory M. Glenn -- President, Research and Development

Well, that's the question we're going to ask. But you're right. And in fact we'll go -- we're planning going back to the US and asking them to revisit that issue as well. So, we're going to-- these are all legitimate questions for us to ask. I don't think there's anything that's cast in concrete. This is as I try to emphasize, this is a huge global healthcare problem, nobody's been successful with any Phase 3 efficacy trial that had there and gotten into phase 3 efficacy trial.

And we've demonstrated efficacy and above all, we've demonstrated safety and there's no safety benefit ratio. There's no issue on safety. So any efficacy is a plus and, we're very confident going into these places and I think it will make it -- we'll make them think twice before they take a non-thoughtful path -- pathway to thinking about a problem where we need to do further.

So that wasn't a very elegant way of saying it. But we think we have a licensable product.

George B. Zavoico -- B. Riley FBR -- Analyst

And finally I have a question about your share count. I mean, it's well over $450 million now and you're trading under $1. You've been there for a couple of months now. With regard to any sort of reverse split or anything like that. Any plans for that, you haven't been there for so long and you could have some significant results coming in decisions by the FDA that could -- that could bring you back over $1. So are you thinking of that or you're going to wait?

Gregory M. Glenn -- President, Research and Development

In fact you missed an 8-K that we filed. So we -- we are doing a reverse split, but it will go -- it will happen on May 8th, and we decided we didn't want to have to deal with -- we want to be so focused on all of these opportunities we have in flu and RSV that we didn't want to be dealing with anything with Nasdaq and so we took -- bit the bullet a while back and said we're going to it reverse and so we're doing a big one.

So it's a 20 to 1, 1 for 20 and it will take us completely out of the ballpark.

George B. Zavoico -- B. Riley FBR -- Analyst

But NASDAQ give you leeway there for several months at least a year I think, right?

Gregory M. Glenn -- President, Research and Development

They do. They give you six months.

George B. Zavoico -- B. Riley FBR -- Analyst

Six months?

Gregory M. Glenn -- President, Research and Development

There's no reason -- there's no reason not to do it. I am now convinced that, I better not -- I've been against this split most of my career and I'm now convinced most -- most people will -- will talk about companies that do a reverse typically go down following a reverse. It's not universally true. And I believe that most of those companies continue to go down because they're trying to solve a problem when a Company didn't have a bright light ahead of them.

We have -- we have two late stage clinical products that have efficacy data, that have strong data and we think that this reversal split would -- will really help us get back to the investor base when we want (ph).

Stanley C. Erck -- President and Chief Executive Officer

And in addition to available shares to that would allow us and at the right time to make an additional raise, George and also there's some important dates for kind of a Russell rebalancing that's coming up. That's important to who is holding our stock. So for those three reasons, we thought it was the right time to make a decision to do the reverse split.

So it wasn't simply based upon being below $1 because you're absolutely right, you have at least six months to cure that. But for these three reasons collectively, it was important for us to make this move now.

George B. Zavoico -- B. Riley FBR -- Analyst

I see. So basically you want to get this part out of the way by May 8th, you said and then concentrate just solely on ResVax and NanoFlu and not worry about any sort of --

John J. Trizzino -- Senior Vice President, Chief Business Officer and Chief Financial Officer

That's exactly right, George. Fluctuations you'll take the hit and hope plan for by the (ph) results giving you the rebound.

Stanley C. Erck -- President and Chief Executive Officer

Well, yeah, let's be very clear, because I think we don't expect to take -- I think this move is important for the shareholders. Shareholder value is important for the company our ability to raise additional funding to support ResVax and to support NanoFlu. And also I think important for positioning with the institutional investor community.

So, I think for multiple reasons it's important for our overall strategy of what we're trying to do for the balance of the year.

George B. Zavoico -- B. Riley FBR -- Analyst

Okay. All right. That's it. Thank you very much.

Stanley C. Erck -- President and Chief Executive Officer

You're welcome.

George B. Zavoico -- B. Riley FBR -- Analyst

Okay, George. Good talking to you.

Operator

Thank you. And ladies and gentlemen, this does conclude our question-and-answer session. I would now like to turn the call back over to Stan Erik for any closing remarks.

Stanley C. Erck -- President and Chief Executive Officer

And I'd just like to reiterate -- Sorry, I guess I don't have any closing remarks other than the fact that we look forward to talking to you more during this quarter about the events that we've got on our plate right now. So thanks and thanks for sitting through the conversation.

Operator

Well, ladies and gentlemen, thank you for participating in today's conference. This concludes today's program. You may all disconnect. Everyone have a great day.

Duration: 38 minutes

Call participants:

Erika Trahan -- Senior Manager, Investor Relations and Public Relations

Stanley C. Erck -- President and Chief Executive Officer

John J. Trizzino -- Senior Vice President, Chief Business Officer and Chief Financial Officer

Shawn Egan -- Citigroup -- Analyst

Gregory M. Glenn -- President, Research and Development

Kevin DeGeeter -- Oppenheimer & Co -- Analyst

Michael Higgins -- Ladenburg Thalmann & Co -- Analyst

Turner -- J.P. Morgan -- Analyst

George B. Zavoico -- B. Riley FBR -- Analyst

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