Novavax Inc (NVAX) 2009 Q2 法說會逐字稿

Good morning, ladies and gentlemen.

And welcome to the Novavax 2009 second quarter results conference call.

My name is Javon, and I'll be your coordinator for today.

At this time, all participants are in a listen-only mode.

We will be facilitating a question and answer session toward the end of today's conference.

(Operator Instructions)

Novavax, please proceed with your call.

Good morning.

On today's call will be Novavax's Chairman of the Board, John Lambert, President and CEO, Dr.

Rahul Singhvi, Senior Vice President of International and Government Alliances, John Trizzino, Chief Medical Officer, Penny Heaton, and Senior Director of Finance, Evy Kopsidas.

Statements herein relating to future financial business performance, conditions or strategies, and other financial and business matters, including expectations regarding revenues, operating expenses, cash burn, clinical developments 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.

Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the Company's ability to progress any product candidates in preclinical or clinical trials, the scope, rate, and progress of its clinical studies and clinical trials, and other Research and Development activities.

Clinical trial results, current results may not be predictive of future results, even if the data from preclinical studies or clinical trials is positive.

The product may not prove to be safe and efficacious.

Novavax's pilot plant facility is subject to extensive validation and FDA inspections, which may result in delays and increased costs.

The success of the Company's foreign joint venture and license agreements, the Company's ability to enter into future collaborations with industry partners and government and the terms, timing and success of any such collaborations, the cost of filing, prosecuting, defending, and enforcing any patent claims and other intellectual property rights, our ability to obtain rights to technology, competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility, our ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise, general business conditions, competition, business abilities and judgment of personnel, and the availability of qualified personnel.

Further information on the factors and risks that could affect Novavax's business, financial conditions, and results of operations, is contained in the Novavax's filings with the US Securities and Exchange Commission which are available at www.SEC.gov.

These forward-looking statements speak only as of the date of this earnings call, and Novavax assumes no duty to update forward-looking statements.

Mr.

Lambert, please proceed with the call.

Thank you, Tricia.

This is a very exciting time for our Company, as we have made significant progress in every aspect of our business.

As Rahul will describe in a moment, we recently raised sufficient new funds to retire our convertible debt.

We expanded our international reach with new vaccine development partners in Spain.

We launched new vaccine development programs against respiratory syncytial virus, or RSV.

One of the leading causes of childhood hospitalizations.

We completed enrollment in a Phase II study of our seasonal flu vaccine in adults.

And we moved quickly to create and produce a vaccine against the pandemic H1N1 flu virus, as we announced this week.

I believe these are remarkable achievements for our Company.

And that we are now in a much stronger position to create and capture the value of our vaccine technology.

I congratulate my colleagues on this progress.

Penny Heaton will describe our recent clinical accomplishments in more detail.

But first, I will turn the call over to Rahul now to discuss our corporate progress in more detail and comment on our plans for the remainder of the year.

Thank you, John and good morning, everyone.

On the last conference call, I described how Novavax is in a unique position to participate in international plans and countermeasures to address the pandemic H1N1 flu crisis.

Since that call, we have not only created a VLP vaccine candidate against the 2009 pandemic H1N1 flu virus from the genetic sequences provided by the CDC, but we have completed production of the first batch of that vaccine under what are called current good manufacturing practices, or CGMP, in less than 12 weeks of receiving those sequences.

The importance of this achievement is that CGMP-quality material can be used for human use.

We actually produced the H1N1 VLP vaccine and started animal testing in as little as four weeks of knowing those genetic sequences.

This rapid cycle time, from strain identification to first GMP batch, is great demonstration of our ability to create vaccines to pandemic or new influenza strains.

It's also an impressive but not surprising achievement for our team, which has great expertise in recombinant VLP production technology.

And it's a nice validation of the investment we made last year in our new pilot plant here in Rockville.

Penny Heaton will say more about our H1N1 pandemic vaccine program in a moment, but I want to reiterate our enthusiasm for this program, our excitement about the capabilities in vaccine production, and our strong commitment to applying the VLP production technology to solving important health problems around the world.

That faith and commitment helped us secure our recent agreement with the Spanish government and ROVI Pharmaceuticals to create a comprehensive pandemic and seasonal flu vaccine solution for Spain using our VLP technology.

With the financial support of the Spanish government, ROVI and Novavax will advance the seasonal and pandemic VLP vaccine candidates in Phase III and through regulatory submission to the European Medicines Agency, or EMEA.

Note that this partnership will provide a funding pathway for Novavax to get marketing authorization of the VLP vaccine in the entire European Union, while giving exclusive commercial rights to ROVI in Spain and Portugal.

We will disclose further details on this deal once we finalize definitive agreements in the fourth quarter of this year.

In addition to the development funding, the Spanish government will assist ROVI to build a VLP-based manufacturing plant in Grenada to create enough vaccine capacity to supply Spain and other parts of Europe, Africa, and Latin America.

This agreement, which was announced in June, is a great vote of confidence in our VLP technology and a great opportunity for Novavax to address the growing threat to public health posed by the H1N1 and other flu viruses.

It also validates the regional partnership model, which we have articulated for some years now.

Our partner in India, Cadila Pharmaceuticals, recently launched operations of our joint venture company called CPL Biologicals that will develop and manufacture vaccines, biological therapeutics, and diagnostics in India using technology contributed by both Novavax and Cadila.

In addition, CPL Biologicals will establish manufacturing facilities in India and develop, produce, and sell products, such as the seasonal influenza vaccine and potentially other novel vaccines, against regional diseases such as dengue fever and chikungunya fever, based on Novavax's VLP vaccine technology.

CPL also expects to develop the pandemic H1N1 influenza vaccine candidate in India that Novavax is developing here in the United States.

Our VP of Strategy, Tom Johnston, is available on the call to answer further questions on Spain and the India opportunities as he has been our lead on those deals from the Novavax side.

Our ability to execute such broad international collaborations has been strengthened by our partners' equity investments in Novavax and by additional stock sales which allowed us to retire our convertible debt, strengthen our balance sheet, and secure funds for ongoing and future development programs.

Specifically, since the first quarter, we have raised almost $22 million through our ATM or [anti-]market program and $3 million from an equity investment by ROVI Pharmaceuticals for a total of almost $25 million.

In addition, we retired 100% of our $22 million outstanding convertible debt.

Today, we are enjoying the healthiest balance sheet that I have seen in my five years at Novavax with over $37 million in cash at the end of July and no outstanding long-term debt.

We are very well positioned to continue to create value for our shareholders through vaccine development in influenza and RSV.

I assure you that we will continue to manage our resources prudently, and I'm pleased that Fred Driscoll is joining Novavax as our new Chief Financial Officer.

Fred is a very talented and experienced biotech executive who many of you may know from his previous jobs at Genelabs and other companies.

He has great skills in financial and operations management, deal-making, strategy, and fundraising, and I'm confident that he'll be an asset to our executive team as we continue to build our business.

In addition, we are pleased to have recruited John Trizzino as Senior Vice President of International and Government Alliances.

John is a seasoned executive with deep experience in vaccine markets, and his leadership in these important areas of international government alliances will be critical for the Company.

John is here today on the call to provide you his vision on this important assignment.

I'll now pass it on to John for his comments on this call.

Thank you, Rahul.

Given our press release this week regarding the production of H1N1 vaccine in 11 weeks, and the other positive news of the past 60 days, it is clear that this is a time of great opportunity for Novavax.

Novavax is well positioned to succeed on multiple fronts, and I am pleased to be joining this organization, particularly at this time, and to add my experience and expertise to this management team.

Our activity in the US with H5N1 and H1N1 production to date has validated our strategy to create a rapid, in-border solution for pandemic preparedness and addresses the gaps in the currently available vaccine technologies.

In addition, on July 10th, the Department of Health and Human Services, or HHS, from the Office of the Biomedical Advanced Research and Development Authority, or BARDA, finalized its solicitation for the advanced development of recombinant cell production influenza vaccine.

Novavax will be making a submission to that Request for Proposal by the September 2nd due date.

Our intent to respond to the BARDA RFP, combined with our clinical development accomplishments to date, affirms our dedication and commitment to producing an improved influenza vaccine solution in a US-based facility for both seasonal and pandemic, and I look forward to working more closely with HHS, CDC, and NIH, as we pursue these goals.

In addition to our initiatives with the US government, I have responsibility for operationalizing the agreements with ROVI in Spain and Cadila in India, that Rahul has just described.

In Spain, we have entered into an initial agreement to license our proprietary recombinant VLP vaccine technology to ROVI Pharmaceuticals.

ROVI will use the VLP technology to create a comprehensive influenza vaccine solution for the Spanish government.

I will be working to get a definitive agreement before year-end and then driving toward the goal of EU licensure and deploying our regional manufacturing strategy for our influenza vaccine.

In India, we have launched a joint venture with Cadila Pharmaceuticals under the agreement signed between the two companies in March 2009.

This joint venture, CPL Biologicals, will develop and manufacture vaccines, biological therapeutics, and diagnostics in India using technology contributed from Novavax.

As Rahul has said, CPL Biologicals also expects to develop the pandemic H1N1 influenza vaccine candidate in India.

And so, I will be working closely with the joint venture to accelerate their activities on H1N1 and deploying our regional vaccine manufacturing strategy similar to our plans in Spain.

In closing, I am pleased to be part of this team, and in light of all the current influenza issues capturing the world's attention, and Novavax's demonstrated success to date, I am confident in the significant role we can play to help prevent both seasonal and pandemic influenza and to advance our technology for other underserved infectious diseases.

Thank you.

Now I'll turn the call over to Penny.

Thank you, John, and good morning everyone.

There have been several remarkable developments with our VLP vaccine since the last earnings call, and I want to take this time to share those with you.

Let's first discuss RSV.

By way of reminder, RSV is the leading cause of hospitalizations in children and a leading cause of hospitalizations for pneumonia in older adults, second only to influenza.

As we have announced, our Novavax scientists and our academic collaborators from the University of Massachusetts have created several different RSV VLP vaccine candidates over the last several months.

All of these vaccines performed well in preclinical studies in mice, inducing antibody to neutralize RSV and also inducing good cell-mediated immunity.

These responses are important to prevent infection and to prevent the spread of RSV down the respiratory tract into the lungs.

But now, we have selected a final vaccine candidate to move forward into additional preclinical studies.

And, if the results are favorable, we plan to be in the clinic the first half of next year.

This vaccine is made up of the RSV-F or fusion protein.

It is presented as a particle in a three dimensional structure that is identical to that of the F protein on the native virus.

The F protein is an important vaccine target because it's on the surface of RSV and allows the virus to attach and fuse the cells in the respiratory tract.

Therefore, antibody against the F protein can protect against infection and spread of the virus.

The RSV-F vaccine candidate that we have selected was highly immunogenic in mice inducing neutralizing antibody.

And, it protected against RSV replication in the lungs, even at very low doses.

In addition, the vaccine candidate can be made of the very pure preparation at yields appropriate for commercial manufacture.

We are enthused about these results, and we have moved forward with studies of the vaccine in cotton rats, the results of which we expect to have available later this fall.

Now let's move on to our influenza programs.

First, I want to provide you with an update on our seasonal influenza VLP vaccine program, and then I will close with a discussion of the H1N1 2009 pandemic and our associated activities on that front.

The dose-ranging study of our seasonal influenza VLP vaccine, which was enrolled in May, is progressing as planned.

No serious adverse events have been reported to date, and we are on track to have the first scheduled analysis of safety and immunogenicity later this quarter.

We also remain on track to begin another study of our seasonal vaccine in older adults over 60 years of age in the fourth quarter of this year in the US and India, and that will be our third clinical study with our seasonal flu vaccine.

The study this fall will be a dose-ranging study of approximately 480 subjects, conducted head-to-head against a licensed, egg-based vaccine, and safety and immunogenicity will be evaluated.

Another important reason to conduct this study is to look at the ability of the two vaccines to induce HAI antibody responses against strains grown in cell culture, which are a match to those strains that circulate among humans and cause illness, as compared to the HAI antibody responses that you might see in strains that are adapted to grow in eggs.

We will also be looking at the antibody responses to neuraminidase and cell-mediating immune responses.

The data from the first scheduled analysis of this study is planned to be available in the first quarter of next year.

And finally, I would like to address the H1N1 2009 pandemic.

As all of you are likely aware, the World Health Organization, or WHO, declared an influenza pandemic associated with the AH1N1 2009 strain on June 11th.

This week, they projected that approximately 2 billion of the world's citizens will be infected with the virus before the pandemic is over.

The US government's advisory committee on immunization practices, or ACIP, has now made recommendations for vaccination of specific populations and risk groups.

Although they do not anticipate a shortage of novel H1N1 vaccine, there is some possibility that initially the vaccine will be available in limited quantities here in the US.

Ultimately, vaccine supplied from licensed manufacturers is expected to be adequate for the US and other industrialized countries, but will likely be limited in economically emerging regions and less developed and developing countries.

Now, I'd like to discuss Novavax's activity on H1N1.

A detailed outline of all of the activities that we have accomplished to date may be found on our website, at www.novavax.com.

Just click the H1N1 tab.

But to summarize here for you, as announced this week, Novavax made VLP vaccine at our pilot plant here in Rockville, Maryland, against the H1N1 2009 pandemic strain in just 11 weeks from the time the genetic sequence was available from CDC.

We received RNA from CDC for the pandemic strain on April 29th.

By May 20th we had made VLPs in the laboratory and shipped them to CDC for animal studies.

The results of which will be available later this month.

And then, full-scale 1,000-liter production was initiated on June 5th, and our first batch was completed on July 15th.

We are now planning to make additional vaccine for clinical trial, which we are discussing with multiple partners in several countries.

We also stand ready to assist with additional public health needs in the US and abroad.

So stay tuned.

We will keep you updated through our website and through special announcements about our activities regarding the novel H1N1 pandemic vaccine.

Before I turn the call over to Evy, I would like to take a brief time out to thank all of our employees at Novavax for making this past quarter such a success.

The H1N1 pandemic brought unexpected work that they, who are already small in number, had to absorb into their already busy schedules.

They were able to work on the H1N1 program and keep our seasonal and RSV programs on track.

So they have accomplished amazing feats, and for that, we are very appreciative.

Now I would like to turn the call over to Evy.

Evy?

Thank you, Penny.

I would like to give a brief synopsis of our second quarter financial results, which were announced in this morning's press release and will be fully discussed in our Form 10-Q which will be filed by close of business on Monday, August 10, 2009.

We closed the second quarter with total cash, cash equivalents, and short-term investments of $31.2 million, compared to $33.9 million at the end of 2008.

The balance at June 30, 2009 is being reported net of $2.1 million in accumulated impairment charges for our auction rate securities, primarily due to their continued illiquidity.

During the second quarter, we recorded a $0.5 million other than temporary impairment related to one of our auction rate securities.

Separately, we recorded $0.5 million as a recovery of fair value, previously recorded as impairment losses related to four of of our auction rate securities, and we have recorded this recovery as an unrealized gain in the Company's other comprehensive income.

The net decrease in cash, cash equivalents, and short-term investments, since the end of 2008 of $2.7 million is primarily due to cash spent for our operations and $12.1 million paid for the early retirement of a portion of our convertible debt in April.

These expenditures were substantially offset by the net proceeds of $10.7 million received from Cadila and net proceeds of $14.0 million received from the sale of stock under the Wm.

Smith sales agreement.

Subsequent to June 30th, the Company also received gross proceeds from ROVI of $3 million and proceeds from additional sales of stock of $8 million related to the ATM program.

We used a portion of these proceeds to retire the remaining $5 million of our $22 million in convertible debt on July 15th by paying $2.6 million in cash for principal and accrued but unpaid interest and issuing approximately 1 million shares of common stock for the remaining principal and accrued interest balance of $2.6 million.

Based on our cash and short-term investments balance as of June 30, 2009, along with the proceeds received from ROVI and the proceeds received from additional sales of stock discussed above, we believe we have sufficient funds to execute our current business plan for at least the next 12 months.

We may raise additional capital in the future through public or private equity and-or debt financing in order to pursue our plan beyond the second quarter of 2010.

Other than potentially selling the remaining shares under the ATM program, which is up to $25 million in sales maximum, we do not have any specific agreements for financing at this time.

Now, let me turn to the operational results.

Revenue for the second quarter ended June 30, 2009 was $29,000 compared to $0.3 million for the same period in 2008, a net decrease of $0.3 million due to the completion of two contracts in 2009.

Research and Development costs for the Company for the second quarter were $5.3 million, compared to $5.4 million in the second quarter of 2008.

The decrease was due to a $0.2 million decrease in employee costs, partially offset by $0.1 million increase in our outside testing costs associated with the continuing clinical trials, preclinical testing, manufacturing and quality-related programs.

Our general and administrative costs were $2.6 million in the second quarter of 2009, compared to $3.2 million in the prior year.

This decrease was due to a decrease in our employee costs of $0.2 million, a decrease in facility costs associated with our general and administrative functions of $0.1 million, and a decrease in charges to the allowance established for two notes receivable from former directors of $0.1 million.

In 2008, we concluded that these notes receivable should be classified as a reduction of equity, and consequently, have not recorded any further reserve charges.

The balance of the decrease is attributable to a decrease in our professional fees.

The Company recorded net interest and other expense of $0.7 million for the second quarter of 2009, compared to net interest and other expense of $0.1 million for the second quarter of 2008.

The increase resulted from an additional impairment recorded as other than temporary in the amount of $0.5 million, which we just discussed, for one of our auction rate securities, and a decrease in our interest income of $0.2 million resulting from a decrease in the average cash and short-term investment balances during the quarter.

These changes were offset by a decrease in our interest expense resulting from the Company's early retirement of $17 million of our convertible debt in April 2009.

As a result of these changes in income and expenses, we are reporting a decrease in our net loss for the second quarter of 2009 of $8.5 million, or $0.10 per share, compared to $9.4 million, or $0.15 per share for the second quarter of 2008.

The loss for the second quarter of 2008 includes a $1.1 million loss from Discontinued Operations.

I'd like to remind everyone that we have reported all activities related to the production of Estrasorb as Discontinued Operations for the second quarter of 2008.

The financial results for all periods presented in both our press release and Form 10-Q have been reclassified to separately disclose these results.

As the Company completed its obligations related to the Graceway agreements in 2008, as planned, there has been no further activity related to these Discontinued Operations.

Now, I would like to turn it over to Rahul for his summary comments.

Thank you, Evy.

And I want to end by reiterating that with a strong balance sheet, we are well positioned to meet the many challenges of the many different opportunities that are in front of us.

The significant upcoming value drivers for the Company include the preclinical data from our pandemic H1N1 vaccine, the Phase II clinical data from the dose-ranging study of the seasonal flu vaccine in healthy adults, the initiation of the critical elderly study with our seasonal flu vaccine, continued progress in our RSV vaccine program toward an IND in the first half of next year, submission of our proposal to HHS BARDA for a contract for advanced development of recombinant influenza vaccines, and regional partnership deals -- in particular, completing the definitive agreements with ROVI.

We look forward to updating you on these events in future calls.

Thanks for your continued support.

We are now happy to take any questions.

Thank you.

(Operator Instructions) Our first question comes from Brian Abrahams.

Thanks for taking my question, and congratulations on all the progress in the clinical, financial, and personnel fronts this past quarter.

A question for Penny on the CGMP batch for H1N1 vaccine.

I'm just wondering, when can we look toward seeing data made available?

Or presented or published on either the process itself or the end product?

And what are the steps to getting this product externally validated?

Thank you for that question.

So with regard to data on -- I just want to clarify.

Are you talking about data on the actual manufacturing process or preclinical, clinical data?

I was talking about data on both the manufacturing process and on the end product.

Beyond any mentioned that you'll be reporting some of the preclinical data.

Sure.

At the end of the year.

But I was just wondering if there was going to be anything beyond that?

Any data basically discussing process for producing this and the end product?

Right.

And the tests that were run on the end product to validate that it is indeed what you -- ?

Sure.

So what I will do is I'll address the clinical portion of it, and then I'll defer to Rahul to address the manufacturing part of it.

Jim Robinson, who is our head of Manufacturing, Technical and Quality Operations, is actually on vacation this week.

Just to talk about the clinical portion of it, we are actually working with multiple partners, literally around the globe to look at conducting H1N1 clinical studies.

And we will be announcing very soon more information about that.

And of course the timing, the start of the clinical trials will dictate when the data are available.

But we will be giving you an update here over the next several weeks about when we anticipate trials starting.

And then of course, when data would be available.

So I don't have a lot for you specifically today.

But stay tuned because we've got more information very, very soon.

Rahul, do you want to address the manufacturing question?

Yes, Brian.

Most of the CMC work is going to be reported, as Penny pointed out.

When we do the clinical trials, it will be under an IND.

So it's going to be proprietary information that will go into an IND.

I know investors might be interested in specifics like yields, et cetera.

And over time, we'll find appropriate venues to disclose those types of information.

But a the moment, we are more focused on ensuring that we get our regulatory filings done.

Okay, that makes sense.

One other question.

Can you walk us through the process that you'll be taking to respond to BARDA's Request For Proposal and give us a general expectation for the timing and what might be the magnitude of funding potentially available through this?

I can just maybe mention a couple of things that I know.

The numbers that are talked about in terms of what the funding levels are, are not known.

Nobody knows what they are, and any numbers are all speculations.

But there is something I can say about timing.

As I think John Trizzino pointed out, that the proposals are due on September 2nd.

And the RFP speaks to making these awards in February of next year.

I believe that somewhere in between, if they stay with that time line -- some time in between -- they will at least notify those offerers who are going to be in the competitive range.

And that could be publicly disclosed.

Okay.

And last question.

What would the cost be to either build or modify your facility in order to handle a potential surge, which I think was one of the conditions in the RFP?

That's very dependent on the yields.

And if we have fantastic yields, the investment -- additional investment may be minimal.

But if we have to build or purchase new equipment, it could be about $10 million in this facility.

If we have to build another facility, that could with additional money.

I think it's premature for me to really nail down what exact investment that would be.

Okay.

Thanks for taking the questions.

Thank you.

Our next question comes from Elemer Piros.

Good morning.

Can you hear me?

Yes, how are you?

Okay.

This question is for either Rahul or Penny.

So I think you mentioned that you provided the CDC-NIH VLP material a few weeks after you received the sequence information, and they are doing some sort of animal studies with that version of the vaccine.

Would you be a little bit more specific, what sort of experiments are ongoing?

And what other companies that you're aware of was able to supply material this quickly?

And what would make the experiments conducted with your material unique, if anything?

Sure.

I think what makes the experiments conducted with our material unique is how quickly we were able to get them material.

As I indicated in my summary, we were able to have VLP vaccine to them by May 20th, which was just a little over three weeks from the time the pandemic strain was announced.

And the reason why we were able to do that is because of our recombinant technology.

We don't have to wait for a virus to be grown in eggs to be adapted to eggs, and in order to start our vaccine production process, if you will.

Once we get that genetic sequence or the RNA, we can take off from there and have the VLPs actually created within just a few weeks.

And then of course, for GMP material that would be appropriate for clinical trials, that takes a bit longer.

And we just announced that this week -- that would be about 11 weeks for us.

That's the unique part is the ability to respond very rapidly.

The types of studies that they're doing, we are looking at a study in ferrets.

And the reason for that is, that as far as the animals go, the ferret is the most important model for influenza.

CDC had to work very diligently in order to get their ferret model validated for this particular strain of flu, but they were able to do that quickly.

And we've now -- we're now in the process of waiting for the data to see how immunogenic and protective the VLPs were against the pandemic strain.

We're really excited about these results.

They'll be released, as I indicated, over the next several weeks.

And certainly, I'm sure that you'll be hearing more about that.

And Penny, just as a follow-up.

Are you aware of some other technologies that are being tested in parallel in those models?

We are not, but I wouldn't necessarily expect to know about that.

Other companies may want to keep that information confidential, and CDC certainly would keep that confidential if it was requested.

So I don't know one way or the other if there are other vaccines that are being tested in the ferret model.

Okay.

And how much more work do you need to do in order to submit an IND?

And what -- if you could just describe in generic terms, what sort of steps need to be taken.

Sure.

So generically, FDA has announced now at several meetings, including a meeting of their advisors that took place just a couple of weeks ago and at the ACIP, the process for doing clinical trials for H1N1 vaccine.

And so we're going to follow that standard process.

We already have toxicology and preclinical data for several other influenza strains.

I know for H5N1 strain, and then for a couple of different trivalent seasonal influenza vaccines that we already evaluated in the clinic.

So we can use those data and actually cross-reference those INDs to help support the H1N1 IND.

So at this point, it's really a matter of just making more vaccines for the H1N1 strain.

And then obviously, working out with our partners the design of the clinical trials, and then putting that information together and cross-referencing other INDs -- or other flu INDs to help support this IND.

So basically, this is a very similar process as to what all companies are proceeding forward with.

And so do you think that you could actually file an IND during the next, say, 30 to 60 days?

Or is it a little bit beyond there?

Probably is a little bit beyond there.

I don't want to comment too specifically, but probably just a little bit beyond that.

I think by fourth quarter we would be looking at filing an IND and getting ready for clinical trials.

Okay.

Wonderful.

Thank you so much for taking my questions.

I'm showing no further questions in the queue.

Okay.

Well, with that then, I would like to end the call.

And I want to again thank everyone for their support, and we look forward to again updating you in the next several months.

Ladies and gentlemen, thank you for your participation in today's conference.

This concludes the program.

You may all disconnect.

Everyone have a great day.