Q4 2019 Earnings Call

Station, there will be a question and answer session to ask a question. During the session. You wanted to press star one on your telephone. Please be advised that today's conference is being recorded if you require any further assistance. Please press star zero I would now like to end the conference over to your speaker today, Erica Troha senior manager of Investor and public relations. Thank you.

Operator: There will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Erika Trahan, Senior Manager of Investor and Public Relations. Thank you. Please go ahead, ma'am. Thank you, operator. Good afternoon. I'd like to thank everyone who has joined today's call to discuss our fourth quarter 2019 operational highlights and...

Please go ahead ma'am.

Thank you operator.

Good afternoon.

I'd like to thank everyone, who is joining today's call to discuss our fourth one or 2019 operational highlight in financial result.

A press release announcing earnings is currently available on our website and Nobody's axon and.

Erika Trahan: A press release announcing 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 be available for the Q&A portion of the call. Before we begin with 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 strategy in other financial and business-related matters, including expectations regarding revenue, operating expenses, cash usage in clinical development, and anticipated milestones, are forward-looking statements within the meaning of the Private Security Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which may change over time. I'll now hand it over to Stan to start today's call.

An audio archive of this conference call will be available on our website later today.

Joining me on todays call, our Stan Erck, President and CEO of knowing that.

And John Trizzino, Chief business Officer in Chief Financial Officer.

Dr. Gregory Glenn our friends in research and development will be available for the Q any portion of this call.

Before we begin with prepared remark I need to remind you and we will be making forward looking statements. During this teleconference.

I think weve financial clinical for commercial projection.

David's relating to future financial or business performance conditions were strategy and other financial and business related matters, including expectations regarding revenue operating expenses.

Cash usage in clinical development and anticipated milestones a 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 overtime.

I'll now hand, it over to stand to start today's call.

Stan Erck: Thanks, Erika, and thanks to all who have joined the call. As you know, we are responding to the emerging coronavirus situation and, at the same time, maintaining our progress with our flu and RSV programs. We are operating in a very exciting time for the company and, hopefully, for our investors. I will use this call to summarize activities in four key areas of our operations.

Thanks, Good and thanks to all who joined the call as you know, we're responding to the emerging growing better situation at the same time, maintaining or progress with our fluid R&D programs.

We're operating at a very exciting time for the company and hopefully for investors.

I will use this call to summarize activities at four key areas of our operations.

First we were about to Unblind data from our pivotal phase three clinical trial Fernando flu as all who are on this call no.

Stan Erck: First, we are about to unblind data from our Pivotal Phase III clinical trial for nanoflu. As all who are on this call know, nanoflu is our adjuvanted recombinant nanoparticle quadrivalent influenza vaccine being targeted initially for the older adult market. This is a market in need of a better vaccine, and to remind everyone, there are a couple of key points about this program. In Phase I and II clinical trials, nanoflu was compared to the best-selling older adult flu vaccine, Fluzone High Dose. In those trials, nanoflu demonstrated higher antibody responses to the mismatched or drifted flu strains that were circulating each year, and nanoflu induced flu-specific T cells that are likely to be important for protection.

I don't lose or educated recombinant nanoparticle quadrivalent influenza vaccine.

Being targeted additionally, the older adult work.

This is a market need a better vaccine and to remind everyone. There a couple key points about this program.

In phase one two clinical trials nanofluid compared to the best selling older adults flu vaccine Fluzone high dose and those trials that'll flow demonstrated higher antibody responses to the mismatch or drifted boustridge there were circulate each year.

And then it'll flow induced foolish specific T cells that are likely to be important for protection.

Stan Erck: We believe that these attributes differentiate us from leading licensed vaccines. The current Phase III trial, approved by the FDA, again compares our nanoflu vaccine to a licensed flu vaccine. But this time, it is compared to Fluzone, which is a quadrivalent egg-based standard dose vaccine. Success will be determined by showing our vaccine is non-inferior to Fluzone. We are confident that we will meet this criterion. In addition, we expect to be able to identify the same key differentiating attributes that we saw in phases one and two.

He believes that these attributes differentiate us from leading licensee exceeds the current phase three trial approved by the FDA again compares are now flu vaccine to a license flu actually.

At this time as compared to flu zone, which is a quadrivalent <unk> based standard dose to actually.

Success will be determined by showing our vaccine is non inferior to this compare.

We're confident that we will lead this criteria. In addition, we expect to be able to identify the same key differentiating attributes that we saw in phase one and two.

But I was going on targets since it started in October of last year as we've previously communicated or plan to unblinded announced topline results by the end of this quarter.

Stan Erck: The trial has been on target since it started in October of last year, as we have previously communicated our plan to unblind and announce top line results by the end of this court. From those data, we will have a clear view of the pathway and timeline to file a BLA. The main activity remaining for this program will be to finish all of the CMC, or manufacturing activities, leading to clinical consistency lot trials and filing a BLA. To remind everyone, we have been granted an accelerated approval pathway and fast-track status for this vaccine. And that should help us as we move forward toward commercialization. Both designations validate the importance of the program to regulators and public health officials.

For those data, we will have a clear view of the pathway timeline to file ability. The main activity remain for this program will be to finish all of the CMC or manufacturing activities, leading to clinical consistency lot trials and filing to be delay.

To remind everyone. We have been granted accelerated approval pathway and fast track status for this action that should help us as we move forward toward commercialization.

Both designations validate the importance of the program to regulators public health officials.

Next I need to spend some time discussing corona virus or Covidien 18.

Stan Erck: Next, I need to spend some time discussing the coronavirus or COVID-19. I don't think that there's anything that I can add about the status and threat of COVID-19 that you don't already know. We all understand the very clear need for new diagnostics, new antiviral treatments, and new vaccines. Novavax is among several companies that are racing to develop such a vaccine. And to remind everyone, Novavax has a special history of developing vaccines against emerging viruses in record time. In the last half-dozen years, we have developed two vaccines against the pandemic influenza strains H5N1 and H7N9. With H7N9, we developed the vaccine for published gene sequence to vaccination of human subjects in 90 days. Wait, excuse me. We also developed an Ebola vaccine that went into a phase one trial and, with the NIH, demonstrated 100% efficacy with very low vaccine doses in non-human primates when they were challenged with live Ebola.

I'll take that there's anything that I can add about the status in thread of cobot 19 that you already don't know.

We all understand the very clear nave produce diagnostics, new anti viral treatments and new vaccines.

No the axes among several companies that are racing to build such a vaccine to remind everyone knows acts as a special history in developing vaccines against emerging viruses in record time.

Over the last half dozen years, we have developed to vaccines against the pandemic influenza strains H five in one.

At age 71.

With a seven to nine we developed the vaccine for published gene sequence to vaccination of human subjects in 90 days.

With excuse me.

We also developed in a volatile vaccine that went into phase one trial with the NIH demonstrated 100% efficacy with very low vaccine doses and non human primates. When they were challenged with live a bola.

And finally, we previously developed to Corona vaccines.

Stan Erck: And finally, we've previously developed two coronavirus vaccines, two coronavirus vaccines, one for SARS and one for Middle East Respiratory Syndrome. With this track record, we are now seen as one of the leading companies to develop a COVID-19 vaccine. This week, we were awarded a grant from the Coalition for Epidemic Preparedness Innovations, or CEPI, to fund our work with the expectation that the funding will cover our costs through a phase one clinical trial. The steps that we've taken include taking the published gene sequence and engineering multiple vaccine constructs. Taking those constructs and demonstrating that they are properly folded and that they bind to a key human receptor, the receptor that is the pathway for coronavirus infection. Having successfully made these constructs, we are now testing them in animal models, including mice and non-human primates.

Two corona virus actually use one for Sars, one for middle East respiratory syndrome.

With this track record we are now seen as one of the leading companies to develop the Covidien 18 vaccine.

This week, we were awarded a grant from the coalition for epidemic preparedness innovations are sufficient to fund our work with the expectation that the funding will cover costs through phase one clinical trial.

The steps that we've taken include taking the published gene sequence and engineering multiples actually constructs.

Taking those constructs demonstrating that their properly folded and that they bind to a key human receptor receptor, there's a pathway for corona virus infection.

Having successfully made these contracts we are now testing them in animal models, which includes mice and non human primates. The goal is to find the best construct that has the highest affinity buying that produces neutralizing antibodies and it can be produced at high levels.

Stan Erck: The goal is to find the best construct that has the highest affinity binding that produces neutralizing antibodies. In parallel, we have contracted with our manufacturing partner, Emergent Biosolutions, to make GMP-grade materials for Phase I and II clinical trials. This will be critical for the start of human trials. We're hoping to start the first trial in May or possibly June, with data expected in the summer. We're not certain of the exact pathway to licensure and deployment at this time, but we are working closely with the FDA to define that pathway. And finally, we are working to identify the best pathway to initiate large-scale production that could be initiated before the end of this year. We expect a constant news flow throughout this year as we make our way through this process.

Parallel we have contracted with our manufacturing partner emergent biosolutions to make GMP grade materials for phase one or two clinical trials. This will be critical for the start of human trials.

We're hoping to start the first trial in May and possibly June with data expected in the summer we're not certain of the exact pathway to leisinger deployment at this time, but we're working closely with the FDA to define that pathway.

Finally, we are working to identify the best pathway to identify large scale production that could be initiated before the end of this year.

We expect to constant news flow throughout this year as we make our way through this process currently and particularly with the initial seppi Grant we believe that there will be sufficient sources of capital outside the company that we will not be slow down by a lack of capital.

Stan Erck: Currently, and particularly with the initial CEPI grant, we believe that there will be sufficient sources of capital outside the company that we will not be slowed down by a lack of capital. With RSV, we continue to believe in our RSV vaccine. We are the only company to have demonstrated potent efficacy in clinical trials in both the older adult population and by vaccinating pregnant women to protect their infants. However, as we have reported over the past years, when we tested our vaccine in phase 3 trials in both cohorts, we failed to meet our pre-specified primary objective.

With our actually we continue to believe it or RSV vaccine. We're the only company to have demonstrated potent efficacy clinical trials in both the older adult population and by the actually pregnant women to protect the revenues as we have reported over the past years, when we tested our vaccine in phase three trials in both core cohorts, we failed to meet our pre.

Specified primary endpoint.

Stan Erck: With those clinical trial outcomes behind us, we also have observed and carefully pointed out that the vaccine actually had significant effects on hospitalization and pneumonia in both trials. With those data in hand, we are working to design new clinical trials that can take us to a licensed product. We now believe that our vaccine is too important for its impact on global healthcare to ignore. The main reason that we haven't been able to follow up as quickly as we want is financial. We believe that we can design an affordable pathway to a licensed product over the coming years, and we'll report on that progress in the future. Moving on to new opportunities

Those clinical trial outcomes behind US. We also have observed and carefully pointed out the vaccine actually has had significant effects on hospitalization pneumonia in both trials.

With those data in hand, we are working design, new clinical trials. It can take us to a license product. We now believe it or vaccines to aboard for its impact on global health care to ignore the main reason that we have been able to follow up as quickly as we want this financial resources. We believe that we can design and affordable pathway to a license product over the coming years.

We'll report or that progress in future.

Moving to new opportunities.

As you May have observed we have been incorporated or matrix imagine in more of our clinical trials, we purchased a Swedish company. It's good over the developer of matrix him about six years ago maker. Jim has been found to be a very safe and robust edge of it is now being used in more and more clinical trials. We have recently used matrix him.

Stan Erck: As you may have observed, we have been incorporating our MatrixM adjuvant in more of our clinical trials. We purchased a Swedish company, Isconola, the developer of MatrixM, about six years ago. MatrixM has been found to be a very safe and robust adjuvant, and it's now being used in more and more clinical trials. We have recently used MatrixM with our NanoFlu Quadrivalent vaccine, our old, I'm sorry, our RSV older adult vaccine, our Ebola vaccine, and are now planning on using it with our COVID-19 vaccine. Safe and effective adjuvants are difficult to find, and we think we have one of the top tier adjuvants in the industry. A new example of the use of MatrixM is the use with a new candidate malaria vaccine.

With our Nanofluid quadrivalent.

[noise] vaccine, our our old sorry are you at our RSV older adult actually.

Our Boulder vaccine and are now planning and use it with our Covidien 18, mixing safe and effective engagements are difficult to fine.

We have one of the top tier graduates in the industry.

A new example, the use of beta Jim is use with a new candidate malaria vaccine Professor Adrian Hill for the gender instituted Oxford University. After years of evaluate a long list of engines chose to Formulators malaria antigen with matrix. It has demonstrated both safety and potent immunogenicity and preclinical.

Stan Erck: Professor Adrian Hill of the Jenner Institute at Oxford University, after years of evaluating a long list of antibodies, chose to formulate his malaria antigen with MATRIX-M. He has demonstrated both safety and potent immunogenicity in preclinical clinical trials involving healthy adults and is now evaluating the vaccine in efficacy trials in Burkina Faso in children five to 17 months of age. Data from these trials are expected later this year.

Clinical trials involving healthy adults and is now evaluating the vaccine efficacy trials in Burkina Faso in children five to 17 months of data from these trials are expected later this year.

Today, we announced an agreement with the serum Institute of India relation sector Hills antigen is developing the vaccine that also contains matrix.

Stan Erck: Today we announced an agreement with the Serum Institute of India, who licensed Dr. Hill's antigen for developing the vaccine that also contains Matrix M. Our agreement represents a great product opportunity for Novavax. First, Matrix M may become a critical component of a new malaria vaccine to be used in endemic areas. As it is well known, a working malaria vaccine is one of the key gaps in world health care. From a commercially important point of view, Novavax retains the rights to the malaria vaccine. Matrix M vaccine for use with the military and as a traveler's vaccine for travelers going to parts of the world where malaria is endemic.

Our agreement represents a great product opportunity for Novavax.

First our matrix M. They become a critical component of a new malaria vaccine to be used in the demick areas as is well known working malaria vaccine is one of the key gaps and world Health care.

Commercially endpoint important point of view no of actually Taser rights to the malaria.

Matrix him vaccine for use with the military and his travelers vaccine for travelers going to parts of the world where malaria is a debit under the terms of this agreement serum Institute will develop the products are licensure and manufacture the product front over the next this is another great example, the value of Novavax as recombinant nanoparticle management platform.

Stan Erck: Under the terms of this agreement, CIRM Institute will develop the product through licensing and manufacture the product for Novavax. This is another great example of the value of Novavax's recombinant nanoparticle and adjuvant platform. Finally, before I turn the discussion over to John Trizzino to cover our financials, I'll steal some of this thunder. Over the past year or so, I believe that there has been concern about whether the company will be constrained by a financial overhang after we report for nanofluid data. I'm happy to say that we've aggressively addressed this issue over the last few months, and as you will hear from John, our financial position is considerably different than it was since our last reporting period ending September 30th.

Finally, before I turn discussion over to John Trizzino to cover financials.

Oh steel so the stouder.

Over the past year. So I believe that there has been concerned about whether the company will be constrained by a financial overhang. After we report for Nanofluid there.

I'm happy to say that we've aggressively address this issue and over the last few months old.

Over the last few months and as you will hear from John our financial position is considerably different than it was since our last reported period ending September thirtyth.

In the third quarter last year, we aggressively working and reducing our quarterly burn rate.

Even while running the phase three pivotal flu trial, we have substantially reduce or operating expenses in parallel we took the opportunity to build our cash position to a level that takes us well into the future. While we do not make financial projections as a policy from this earnings call. It will declare that we now have over $200 million a cash we believe that this new for.

Stan Erck: In the third quarter of last year, we aggressively worked on reducing our quarterly burn rate, and even while running a Phase III pivotal flu trial, we substantially reduced our operating expenses. In parallel, we took the opportunity to build our cash position to a level that takes us well into the future. While we do not make financial projections as a policy, from this earnings call, it will be clear that we now have over $200 million in cash. We believe that this new financial strength gives us the runway and flexibility to create incredible value for our investors. Thank you, and now I turn it over to John.

And just rig gives us the runway flexibility to create incredible value for investors. Thank you and now let me turn it over to John.

Thanks, Dan today, we announced financial results for the fourth quarter and the full year 2018 for the call today, we will focus on the key results for the quarter 12 month financial results can be found in today's press release.

For the fourth quarter, we reported a net loss of $31.8 million worth $1.13 cents per share compared to a net loss of $49.3 million or $2.57 per share in the fourth quarter of 2018. The reduction of net loss was mainly due to reduced R&D expenses.

John Joseph Trizzino: Thanks Dan. Today we announced financial results for the fourth quarter and the full year 2019. For the call today, we will focus on the key results for the quarter. 12-month financial results can be found in today's press release. For the fourth quarter, we reported a net loss of $31.8 million, or $1.13 per share, compared to a net loss of $49.3 million, or $2.57 per share, in the fourth quarter of 2018. The reduction in net loss was mainly due to reduced R&D expenses that I'll discuss more later. Revenue in the quarter increased 44% to $8.8 million from $6.1 million for the same period in 2018. The increase was driven by $7.5 million in revenue for the recovery of additional costs under the closeout of the HHS-BARTA contract.

I will discuss more later.

Revenue in the quarter increased 44% in $28 million from $6.1 million for the same period in 2018.

The increase was driven by seven and a half million dollars in revenue for the recovery of additional costs under the close out of the HHS BARDA contract.

Partially offset by lower revenue from the completion of enrollment in the participants in the repair trial and the second quarter of 2018.

R&D expenses decreased 32% to $29.3 million in the fourth quarter 2019, compared to $43.4 million in the same period in 2018.

This decrease was primarily due to decreased development activities of raise vacs lower employee related costs and other cost savings due to the Catalent transaction, there were partially offset by not off the phase three clinical trial and development activities.

John Joseph Trizzino: Partially offset by lower revenue from the completion of enrollment and participation in the repair trial in the second quarter of 2018. R&D expenses decreased 32% to $29.3 million in the fourth quarter of 2019 compared to $43.4 million in the same period of 2018. This decrease was primarily due to decreased development activities of ResVax, lower employee-related costs, and other cost savings due to the Catalan transaction that were partially offset by nanoflu phase 3 clinical trial and development activities.

GNS expenses decreased slightly coming in at $8.2 million as compared to $9.2 million for the same period in 2018.

As of December 31st 2019, Novavax at 82.2 million in cash cash equivalents restricted cash.

Net cash used in operating activities for the full year 2019 was $136.6 million compared to $184.8 million for the full year 2018.

John Joseph Trizzino: G&A expenses decreased slightly, coming in at $8.2 million as compared to $9.2 million for the same period in 2018. As of December 31st, 2019, Novavax had $82.2 million in cash, cash equivalents, and restricted cash. Net cash used in operating activities for the full year 2019 was $136.6 million, compared to $184.8 million for the full year of 2018. As Stan mentioned, our financial position is strong. In Q4, we raised $30 million in net proceeds. And from January 1st through March 6th, we have raised $156 million in net proceeds for a total of $186 million since the end of Q3 through our ATM offer. Novavax's cash position as of March 6th is now in excess of $200 million. Our future cash needs, as you would expect, are directly related to nanoflu data and development and preparedness activities associated with the COVID-19 pandemic.

As Stan mentioned, our financial position is strong in Q4, we raised $30 million net proceeds and from January 1st through more six we have raised 156 million net proceeds for a total of $186 million since the end of Q.

Three through our ATM offerings, no that is cash position as of March.

It is now in excess of $200 million.

Our future cash needs as you would expect are directly variable to nanofluid data and development and preparedness activities associated with the co that 19 pandemic. We do expect additional funding from 70 to support activities through phase one clinical trial results.

With this in mind cash used for DNA is expected to remain flat.

Cash used for idea activities is expected to decrease and 2020 as compared to 29 team due to the Catalent transaction.

Which included a reduction in headcount and assignment at facility leases and with the prepare trial expenses concluded at year end.

John Joseph Trizzino: We do expect additional funding from CEPI to support activities through the results of the Phase I clinical trials. With this in mind, cash used for GNA is expected to remain flat, and cash used for R&D activities is expected to decrease in 2020 as compared to 2019 due to the Catalan transaction, which included a reduction in headcount and assignment of facility leases, and with the prepared trial expenses concluded at year end. We look forward to the nanofluid data announcement before the end of this month and are excited by the opportunity we have to develop a vaccine for COVID-19. We are in a financially solid position as we move into 2020. Thank you. This concludes my financial review, and I'll turn the call back to Stan.

We look forward to Nanofluid data announcement before the end of this month and are excited by the opportunity we have to develop a vaccine for Kogan 19, we are financially solid position as we move into 2020.

Thank you. This concludes my financial review and I'll turn the call back to staff.

Thanks, Sean so as.

As we near the ended the quarter, we're looking forward to Unblind interface, three flow data and ER and we'll be talking to once we get those data.

With that I will turn it back to the operator for questions and answers and we'll get answers. Thank you.

As a reminder to ask a question you want me to press Star one on your telephone to withdraw your question press the pound King Please standby well, we compiled the Q and a roster.

Stan Erck: Thanks, John. So, as we near the end of the quarter, we're looking forward to unblinding our phase 3 flu data, and we'll be talking to you once we get that data. With that, I will turn it back to the operator for questions and answers, and we'll give answers. Thank you.

Our first question comes from the line of Kevin Degeeter from Oppenheimer. Your line is now open.

Hey, Congrats guys out what housekeeping question the top and then maybe they'll get some more fundamental question.

John what what was the average pricing where coupon that money off the ATM or put more simply how many shares worksheets how far through March six.

Operator: As a reminder to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from the line of Kevin DeGeter from Oppenheimer. Your line is now open. Congratulations, guys. One housekeeping question at the top, and then maybe we'll get some more fundamental questions. John, what was the average price at which you pulled down money from the ATM, or put more simply, how many shares were issued so far through March 6?

So so we have 19.2 million shares have been issue since March six.

Leaving us with a total of 51.5 million shares outstanding.

Great Thanks for that and.

A few things Yeah, I think you mentioned towards the end of your comment if you're confident that.

They will be finding homes happy to find the phase one development you can you elaborate on adds a little bit different language family here is that I guess earlier in the week with regard to initial 4 million are finding.

John Joseph Trizzino: So, 19.2 million shares have been issued since March 6, leaving us with a total of 51.5 million shares outstanding.

Yes, I think in the press release, we made reference to some of the expected additional funding. So keep in mind. This is a very dynamic prices process, Kevin and so where were moving very quickly seppi and others are moving very quickly and so we were able to get definition around.

John Joseph Trizzino: Great, thanks for that. A few things. I think you mentioned towards the end of your comment that you're confident that there'll be funding from CEPI, you know, to fund the phase one development. Can you just elaborate on that? It's a little bit different language than was used earlier in the week with regard to the initial $4 million funding.

The first stage of funding, which is the $4 million.

We are in constant communication with happy and fully expect that will receive additional funding.

Right now seen other Kevin.

John Joseph Trizzino: Yeah, so I think in the press release we made reference to some of the expected additional funding, so keep in mind this is a very dynamic process, Kevin, and so we're moving very quickly. CEPI and others are moving very quickly, and so we were able to get definition around, you know, the first stage of funding, which is the four million dollars. We are in constant communication with CEPI and fully expect that we'll receive...

I'll make one comment so so I think steffi to its credit knew that everybody who is moving fast in there there are big companies a little companies. Some they were worried that some would not would would hold back on spending money. If they didn't get reimbursed himself. He stepped out had provided money virtually immediately.

You know for a portion of what the total ask wasn't and with the expectation that they would have time to then evaluate the rest of the grant. So so it's a partial payment.

Stan Erck: Right there. Yeah, I'll see. I'll see.

Stan Erck: I'll make one comment. So, CEPI, to its credit, knew that everybody was moving fast and they were big companies and little companies, and some, they were worried that some would not, would hold back on spending money if they didn't get reimbursed. So CEPI stepped out and provided money virtually immediately, you know, for a portion of what the total ask was and with the expectation that they would have time to then evaluate the rest of the grant. So, it's a partial payment.

That makes sense and then I just want to clarify the comments with regard to.

Path forward with ours me I mean is it correct could take away from your comments it yeah with the additional balance sheet flexibility that you explicitly intend to.

Explore options, including future clinical studies or your RSV program to support control.

Regulatory approval.

For for all the reasons I stated I think the RSV vaccine works really well and I think we have opportunities to get a license product and we intend to designing design trial should address the areas where were at work best and.

Stan Erck: That makes a lot of sense. And then I just want to clarify the comments with regard to the path forward with RSV. I mean, is it correct to take away from your comments that, you know, with the additional balance sheet flexibility, you explicitly intend to explore options including future clinical studies for your RSV program to support potential regulatory approvals.

Thank you to take it to licensure and I think that Phil you'll see that it will take time is restart those that but maybe by the end of this year into next year, we'll we'll be talking about that.

Stan Erck: For all the reasons I stated, I think the RSV vaccine works really well, and I think we have opportunities to get a licensed product, and we intend to, design trials to address the areas where it works best and take it to licensure. And I think that you'll see that. It will take time to restart those, but maybe by the end of this year or into next year we'll be talking about that.

Got it and just about a final point of clarification on that you know.

John's comments with regard to R&D trends for 2020, I assume that does not include any material at least.

You know pre clinical trial manufacturing or are there RSV related spend or is that a variable that down.

To be worked out throughout the course in here.

Well I think there's a benefit to be worked out but but it should be noted that we have.

Material that is frozen stable ferraris needs. So I don't think left to do any manufacturing.

Kevin DeGeter: Thank you. All right. Thank you.

John Joseph Trizzino: Got it. And just to put a final point of clarification on John's comments with regard to R&D trends for 2020, I assume that does not include any material that we..., you know, pre-clinical trial manufacturing or other RSV-related spend, or is that a variable that is to be worked out throughout the course of the year?

So on our on our piano this year.

She will not have a significant impact.

Hey, congratulations on all the progress guys and best of luck.

Thank you thanks, Kevin.

Thank you. Our next question comes on the line of Eric Joseph from JP Morgan. Your line is now open.

Hi, guys. Thanks for taking the questions I guess just in framing expectations for the.

Stan Erck: I think there's a bit of a bit to be worked out, but it should be noted that we have material that's frozen and stable for RSV, so I don't think we'll have to do any manufacturing. So on our P&L this year, RSV will not have a significant impact.

And if we did that looking at the end of the month.

Understanding that the endpoint is not in non inferior on on that Immunogenicity.

Can you talk about what is there any.

Kevin DeGeter: Great. Congratulations on all the progress, guys.

What expectations there are in seeing superiority and.

Hello, Good nation.

Eric William Joseph: Thank you. Thanks, Kevin. Thank you. Our next question comes from the line of Eric Joseph from J.P. Morgan. Your line is now open.

I'm also curious as to what extent of questions are interested in kind of making contrasts with either that the high dose, but as an option that needed to try mill indoor the quadrivalent.

Eric William Joseph: Hi guys, thanks for taking the questions. I guess, just in framing expectations for the nanofluid data that we'll see at the end of the month, understanding that the end point is non-inferior on immunogenicity, can you talk about what expectations there are for seeing superiority in hemagglutination? And I'm also curious as to to what extent clinicians are interested in making contrasts with either of the high-dose fluzone options, either the trivalent or the quadrivalent. Thanks.

Thanks.

Yes, Hi, Eric This is Greg a couple of things. So we will we do expect to look for as you know as you know the phase one phase two.

Weve demonstrated statistical superiority with respect to the Athree into a JPY responses and we're we're you know we're expecting to replicate that as well so.

That you know that's important and I think you know and our phase two, especially we did a line that up with the.

Greg Glenn: Yeah, hi Eric. This is Greg.

As you noted the high dose tried deal flow and the recombinant quadrivalent flu and you know I think our results are quite good we have.

Greg Glenn: A couple things. So we will, we do expect to look for, as you know, in phase one and phase two, we've demonstrated statistical superiority with respect to the H3N2 HEI responses, and we're, you know, we're expecting to replicate that as well. So that, you know, that's important and I think, you know, in our phase Two especially, we did line that up with the, as you noted, the high-dose trivalent flu and the recombinant quadrivalent flu and, you know, I think our results are quite good. We have a very good HEI comparison and then also we have T cell responses, which, as Dan noted, are expected to be important for protection. So, you know, we're feeling very good about that data as phase 2 data, especially as something we can point to in terms of how the vaccines work relatively.

Very good H.I. comparative.

And then also we have T cell responses, which as Dan noted.

Or expect to be important for protection. So we're feeling very good about that data as the phase two data, especially as something we can point to in terms of how the vaccines work relatively very gratified for phase three trial, you know does demonstrate noninferiority and we have statoil.

School superiority four days three and two straight isn't other bad your flows you probably have seen.

Even though it's all across the virus that in the background I think there's been about 40 billion.

Uhhuh hospitalizations at about 40000 deaths. According to CDC This week.

And so it's still you know and there's been some interesting shifts in what strains are out there, but we can still see a very important niche are important role for this.

Greg Glenn: We'd be very gratified if our phase 3 trial, you know, does demonstrate non-inferiority and we have statistical superiority for the H3N2 strains. But here's another bad year of flu, as you probably have seen. Even though with all the coronavirus in the background, I think there's been about 40 million flu hospitalizations and about 40,000 deaths according to the CDC this week. And so, it's still, you know, and there are some interesting shifts in what strains are out there, but we can still see a very important niche, an important role for this adjuvanted influenza vaccine that we're developing.

Gradually influenza vaccine that we're developing.

Thank you. Our next question comes from the line of Charles Duncan from Cantor Fitzgerald. Your line is now open.

Hi, Dan and team thanks for taking the questions and congratulations on good.

Quarterly progress, particularly the latest you said the ATM I had a quick question regarding nano flew in terms of next steps I'm, assuming that you deliver good data here coming up and that you'll be pursuing a B.L.A. Shortly thank you mentioned that you.

Charles Duncan: Thank you. Our next question comes from the line of Charles Duncan from Cantor Fitzgerald. Your line is now open. Hi Stan and team.

Charles Duncan: Thanks for taking the questions and congratulations on a good quarter of progress, particularly the latest use of the ATM. I had a quick question regarding NanoFlu in terms of next steps. I'm assuming that you deliver good data here and that you'll be pursuing a BLA shortly. I think you mentioned that you need to finish a CMC, and can you provide any additional color clarification on what that might involve and when you may be able to complete the filing of a BLA?

It is finishes CMC and and can you provide any additional.

Color a clarification on what that might involve and when you may be able to complete the filing for BLE.

Yeah, I know that's a big question and we're not answering the question until we see our phase three data that will do that will.

Uh huh.

Give us guidance on how what we do to file the delayed so so I'm just let me keep.

Stan Erck: Yeah, I know that's a big question, and we're not answering the question until we see our face rated. That will... [inaudible] give us guidance on what we should do to file the BLA. So I'm just, let me keep quiet on the timeline for that yet because we don't have one until we see our data, but the specifics on the manufacturing are that we began the process of process characterization starting the summer of last year. We're expecting to do and finish what they call PPQ lots to make material that can be used in clinical trials where you do consist of three lots of product in three groups of trial vaccinees and show that the vaccine And so it's something we have to do, something everybody has to do, and the timing of the VLA will depend upon how fast we can.

Quiet on the timeline for that yet because we don't have one until we see our data, but the the specifics on me on the manufacturing is is that we began the process of process characterization started in the summer of last year.

We're expecting to do and finish what they call P. PQ lots to.

To make material that can be used in and clinical trial that where you do consist of three.

Lots of product in three groups of.

Trial backs knees and show the vaccine numbers behave the same until we it's something we have to do some everybody has to do.

And the timing of the deal they will depend upon how fast we could do those trials.

Oh, Okay stand that.

Good news is it that I'm, sorry, not to give you a date right now, but the good news is that we we not only have.

Stan Erck: Okay, Stan, that's helpful. The good news is, I'm sorry not to give you a date right now, but the good news is that we...

Break that breakthrough, but but the accelerated approval. So that that these data are our kids are licensable, but but also fast track, which gives us which gives us a very active.

Stan Erck: We not only have accelerated approval so that these data are licensable, but we also have fast track, which gives us very active meetings and timelines with the FDA. So we'll use that process.

Meetings and timelines with the FDA, So we'll use that process.

Yes, so that that's helpful and actually Stairstep address my my real question, which is given notice designation.

Charles Duncan: Yes, so that's helpful. That actually starts to address my real question, which is, given those designations, could you imagine, and, of course, favorable data, could you imagine that nanoflu could be in North America or on the market by time of the North American flu season in 21, 22, so not this coming one? Yeah, give me...

Could you could you imagine.

And of course paper, both data could you imagine.

You know that nanofluid could be in north American or in the market by time that North American flu season.

In 21, 22, so that is coming line, but the next one.

And give it give me a quarter or give me post post data to too.

Stan Erck: Give me a quarter or give me the post data to give you some of those projections.

I'll give you some of those projections.

Charles Duncan: Okay, sounds good. And then last question, just moving on to COVID-19. I appreciate all the effort that you are doing and other companies are doing to move rapidly.

Okay. Okay sounds good and then last question I, just moving onto the call that 19. Appreciate all the effort that you are doing and other companies are going to move rapidly wondering if you could provide additional information on the target I think you'd mentioned.

Greg Glenn: I wonder if you could provide additional information on the target. I think you mentioned, well, you didn't actually mention, but could it be the spike protein as being the target? And when would you be in a position to commence a clinical study with that candidate?

Well, you Didnt actually mentioned, but could it could it be despite protein as being the target and when would you be in a position due.

To come into clinical study with that with that Kennedy, Yeah, Hi, Greg Glenn here again, so yes. It is a spike protein we make a full length recommited spiked protein nano particle.

Greg Glenn: Hi, it's Greg Glenn here again. So yes, it is a spike protein. We make a full-length recombinant spike protein nanoparticle. We're using our Agilent MatrixM, very similar to what you're seeing with the influenza vaccine and what we've done before with some of the other emerging diseases.

We are using our edge, but matrix M very similar to what you're seeing you'll see with the the influenza vaccine and what we've done before with some of the other emerging diseases were thinking.

Greg Glenn: Thank you.

Greg Glenn: late spring for FSI. You know we're working hard to make that date as soon as possible.

Late spring for FSRU or you know, we're working hard to make that date as soon as early as possible.

And then Greg could you imagine.

Greg Glenn: And then, Greg, could you imagine, you know, broader utility given that the target is important for other coronaviruses? It seems like the experience that you had with MERS and SARS that perhaps this could have broader utility if something else could evolve or could emerge from the corona bidet over the course of the next few years.

You know broader utility given a target is important for other corona viruses. It seems like take experience that you have with mergers and Sars that perhaps this could have broader utility it if something else could evolve or it could emerge over from the Corona did they over there.

The next few years.

Yes, I think you know coming back to flu that's precisely what we have we have no single recombinant glycan protein is an m. particle wouldn't immunized with that with matrix M. We see broadly cross reacting antibodies to two you know where there has been evolution gripped. So we're going to be very interested in exploring that Todd.

Greg Glenn: Yes, I think, you know, coming back to flu, that's precisely what we have. We have a single recombinant glycoprotein in the nanoparticle. When we immunize with that, with matrix M, we see broadly cross-reacting antibodies to, you know, where there's been evolution and drift. So we're going to be very interested in exploring that topic with our coronavirus vaccine. I think that's a really good idea.

As with our with ours are.

Rotavirus vaccine I think there that's a relevant question and.

Greg Glenn: And we're, you know, we're, I think we're optimistic that we could have some really good, important cross protection.

Were you know were I think we're optimistic that we could have some really good important cross protection.

Charles Duncan: Good deal. Thanks for taking my questions. Good luck with the upcoming data.

The deal Thanks for taking my questions. Good luck with the upcoming data.

Charles Duncan: Thank you.

Thank you.

Thank you. Our next question comes from the line of my young tawny from B. Riley FBR. Your line is now open.

Mayank Mamtani: Thank you. Our next question comes from the line of Mayank Mamtani from V. Riley F.B.R.

Mayank Mamtani: Your line is now open. Thanks for taking my questions, and again, my good wishes to you for a busy 2020 ahead for you. If I can stay with COVID-19 for a minute, could you maybe help contrast your platform approach, the recombinant nanoparticle versus some of the other approaches that are being taken, again, staying with the prophylactic vaccine approaches, not the antivirals? And then the second part of that question was just could you talk about the different strains, MERS and SARS, and what specifically the sequence differences are between SARS-CoV-2

Thanks for taking my question then again my goodness is due for a busy doing 20 I had for you.

If I can stay would go with 19 for a minute could you maybe help contrast, your platform approach to recombinant nanoparticle versus some of the other approaches that are being taken out again staying with the prophylactic vaccine approach is not the antibody.

And then the second part of that question was.

This could you talk about the different streams.

Modest in size than what specifically the sequence differences I retire Scooby doo.

Yes, let's let's go backwards, we'll start with mergers.

Greg Glenn: Yes, so let's go backwards. We'll start with MERS, SARS, and COVID-2. So MERS is in a different genus. That is, it's quite a different spike protein from still a coronavirus. It's a different clade, I should say, and then SARS and COVID-2 are both beta coronaviruses. They have about 70% homology, so they're fairly closely related. A lot of the mutations have happened around the site, around the receptor binding domain, but those two viruses have the same target on the human cell called the ACE2 receptor, so they both bind to that. SARS does not bind as tightly as the coronavirus, so the coronavirus seems to be very infectious, and we think it has to do with a very high affinity of the spike protein for the receptor, and so that's one of the tests that we've employed in evaluating our vaccine to show that the structure is correct. So, you know, I think, you know, with that, we...

Sars and koby too. So sobers is in a different genus that is it's a quite a different spike protein to still a grown viruses different trade I should say and then the Sars and.

Over to our both beta growth of ours is they have about 70% homology.

So they're fairly closely related a lot of the mutations that happen around.

The site.

Rob receptor binding domain.

But those two viruses have the same target on human cell called the Ace two receptor. So they both buy into that Sars not does not buying as tightly as merger as the CRO virus. So the CRO to buyers seems to be very infectious and we think it has to do with a very high affinity of the spike protein.

For the receptor and so that's one of the test that we deployed in evaluating our vaccine to show that the structures is is correct. So.

Yeah, I think you know with that we.

Go back to the first question just remind me. So you guys do on a another platform approach that you haven't what a edgar yeah wishes bambanani or rather a process yeah.

Greg Glenn: So you have-

Greg Glenn: Some approach that you have with SDS.

Greg Glenn: Well, you know, without so first of all, you know, as you as you know, we have platform technology.

Well you know without so first of all you know as you gives you know we have a platform technology. It's made the insect cells tenants XL produce recombinant protein with matrix M.

Greg Glenn: You know?

Greg Glenn: So that platform technology has been used a lot; it's, you know, been in phase three now several times, and is the basis of our nanoflu vaccine. So, as Stan mentioned earlier, we used platform technology to make a MERS and SARS vaccine. We didn't advance them into humans, but they look very good. They were both highly protective in animal challenge models.

So that platform technology has been used a lot it's.

You bet in phase three now several times and arts bases of our data flu vaccine. So as Dan mentioned earlier, we use the platform technology to make a versus ours vaccine. We did the dancing in humans, but they look very good they had the.

Both were highly protected in animal challenge model. So I think you know the fact that we can scale up we know that.

Greg Glenn: So I think, you know, the fact that we can scale up, we know that we can, you know, get a very large, very big and robust, I should say, immune response. And functional immunity, there's a lot, you know, a lot of reasons to have confidence that our vaccine could work. Some of the other platforms include genetic immunization, so one is a DNA immunization. I think for infectious diseases, you know, that's kind of a new application for it. That did, they have some phase one data in MERS on that platform from Inovio.

A weekend.

Get a very.

Large very.

Big robust I should say immune response and functional immunity or there's a lot you know what regions have confidence our vaccine could work some of the other platforms include a genetic immunization. So one is a DNA mutation or I think for infectious disease.

That's that's.

I kind of a new application for that did they have some phase one data numbers would that platform from inovio.

Greg Glenn: I'd say the other maybe, you know, more important technology is the use of mRNA as an immunogen and make it into a lipid nanoparticle. So that is a genetic approach. So like the Inovio, you inject the genetic material, and the spike protein is produced in the human cell, and you develop an immune response to that.

The other maybe even more.

Important technology is the use of and R&D as a immunogen they make it into a little bit nano particle. So that is a genetic approach. So like the inovio you reject the genetic material. The spike protein is produced in this in human cell that you develop immune response to that so.

Yeah. That's that's also a promising technology they have not been out with respect to vaccine prophylactic vaccines, they've not been out of phase one.

Greg Glenn: So again, that's also a promising technology. They have not been out with respect to vaccines, prophylactic vaccines. They've not been out of phase one.

Greg Glenn: There are some other vectors that are being developed. That is, you make an adenovirus, then you put a gene of interest in it. So I think they are using the spike protein gene. So you put a gene expressing the spike protein on the adenovirus, and you use the vector itself as a vaccine. There is, you know, there is a precedent for that. The only licensed Ebola vaccine was a vector-based VZV vaccine, and that was licensed in December of 2019.

There are other some other vectors that are being developed that is you make an arrow bars.

The then you put a genius of interest so I think there isn't a spike protein genes, we put a gene expressing the spike protein on the end of our news the vector itself as a as a as a vaccine. There is a you know there is a precedent for that.

The only license Ebola vaccine was a vector based VZ V.

Maxine and that was licensed in December of 2019. So I think that's you know promising for everyone developing vaccine for that's there has been a vaccine for any emerging infectious disease. So I do think we have very appropriate technology. It's been late stage. We know we can make it efficiently efficiently.

Greg Glenn: So I think that's, you know, promising for everyone developing a vaccine for this, that there has been a vaccine for emerging infectious diseases. So I do think we have very appropriate technology. It's been late-stage.

Greg Glenn: We know we can make it efficiently with high yields. So our matrix M is really key. We've had a number of places where we've been able to demonstrate the importance of using an adjuvant. We know it has a good safety profile. So you know, we're very confident we can address the pandemic here that we're seeing with a good vaccine, and we're working very hard to get that into the clinic in the first instance and try to develop the product in parallel for a larger deployment.

Hi yields so our matrix M is really key we've had a number of places where we've been able to demonstrate the importance of using management we nodes.

He has a good safety profile. So we're very confident we can address the pair Debbie.

Here that we're seeing with a good vaccine that we're working very hard to get that into the clinic. The first cases and tried to develop the product in parallel for a larger deployed.

And maybe a follow up do that on this phase one in the summer study readout that you're thinking about.

Greg Glenn: And maybe a follow-up to that on this phase one in the summer study readout that you're thinking about. Like, what are the subjects? I understand these are healthy, but are you targeting older adults? And what specifically would you be looking for in that data readout?

Like what I started this objects understand these are held the but are you targeting or laid out and what specifically would you be looking player in that data read out.

Yes, so usually started phase one trial in healthy adults, which is what our plan is are we in in terms of read outs it'll be very important to demonstrate that that the mean immunogenicity of strong. So we look for the role of the aggregate. So we have no attribute arm and we have an arm with <unk>.

Greg Glenn: Yeah, so usually you start a phase one trial in healthy adults, which is what our plan is. In terms of readouts, it will be very important to demonstrate that the immunogenicity is strong. So we look for the role of the adjuvant, so we have a no adjuvant arm, and we have an arm with the arms of the adjuvant and the antigens. We haven't really gone over the study design, but in principle, we need to demonstrate the importance of the adjuvant. We will then measure the anti-spike IgG we induce. We then have a number of functional assays where we show that the assay could demonstrate that we block receptor binding, that would be important, and that we make neutralizing antibiotics. And I think those are going to be, you know, you'll see generally accepted types of immune measures in the subjects.

Arms with the ads, but at the averages we have really gone over this study design, but in principle, we need to demonstrate that the importance of the adds a good. We'll then measure the anti Spike I did you induce we didn't have a number of functional assays, where we show that the the assay could demonstrate that we built.

Walk receptor binding to be important and that we make neutralizing antibodies and I think those are are going to be you know you will see generally accepted.

Types of immune measures in the in the subject.

Greg Glenn: Okay, sounds great. And just one final financial question. For the R&D guidance, I mean, with the two studies kind of close to finishing up, like, what are sort of the assumptions as you think about 2020? I mean, there's a lot of comparison studies, but what else is baked in that guidance for 2020?

Okay sounds good and just one final financial question for the R&D guidance.

I mean, the do studies kind of close to a.

Finishing out like what what as part of the as I'm sure. The you'd think about eight to any I mean, there's a lot combined in study they like what else is big bend tied into acquaint Wendy.

John Joseph Trizzino: So we don't give specific guidance here, but in my remarks, I mentioned the fact that we do have some, you know, important activities that will affect R&D expenses. The guidance right now is that I think that R&D expenses will be decreasing. We've been able to keep all of our G&A expenses under control. You have whatever we're doing for coronavirus at the moment with the expectation that that will be funded, a funded program, and then any other spending is completely dependent and variable on flu data. So we'll update you as we get into the year, but the guidance in my remarks is kind of what we'll stand by at the moment.

So so.

We don't give specific guidance here, but I in my remarks, I mentioned, the fact that we do have some you know important activities that will affect.

R&D expenses the guidance right now is it into R&D expenses will be decreasing.

We've been able to keep all of our GNS expenses under control.

You have whatever we're doing for Corona virus at the moment is expectation that that will be funded a funded program.

And then any other spending is completely dependent and variable on anflu data, so well, we'll update as we get into the year.

But the guidance in my remarks, since it's kind of level standby at the moment.

Great. Thanks for taking my question, then look forward to speaking more at the end of the month.

Mayank Mamtani: Great. Thanks for taking my questions, and I look forward to speaking more at the end of the month. Thank you. Thank you. Our next question comes from the line of Michael Higgins from Lattinburg, Salmon. Your line is now open.

Thank you.

Thank you. Our next question comes from the line of Michael Hagen from Ladenburg Thalmann. Your line is now open.

Michael Guba: Hi guys, thanks for taking the questions.

Hi, guys. Thanks for taking the questions and congrats and continued successes.

Michael Guba: Thank you for your questions and congratulations on the continued successes. A question or two on the COVID vaccine that you're working on?

Question or two on Cowen vaccine that you're working on assuming that's the successful animal study and then moving onto some safety shown in the phase ones.

Michael Guba: successful in animal studies

Michael Guba: and then moving on to some safety measures shown in the Phase I's.

Michael Guba: Some history here with your platform, but we don't have that.

We have some some history here with your your platform.

Michael Guba: have a great template to look to to assess your own.

But we don't have a great.

Templates look Q2 assessed here, you're a quantity produce overtime.

Michael Guba: Can you give us some kind of...

Michael Guba: insights as to how much you can produce over what kind of a time frame.

So something that some success.

Can you give us some kind of insight as to how much you produce over.

Stan Erck: I can't understand. And we're actively looking at that. In fact, we had

Over what kind of a tanker.

[noise] can't understand and we're actively looking at that fact with.

Stan Erck: With both Flu and RSV, we explored large-scale manufacturing, and we spent a lot of time developing a manufacturing process for our products that would allow us to commercialize them with our platform process. And we're there. We have good yields. In fact, we have great yields on our products. We don't know what we have on COVID-19 yet, but our expectation is that it will be similar to what we've done before, which gives us both a product that this can produce at a high scale and at a reasonable cost. And that's our expectation. So we've met, we can, it's all scalable. And we've identified, and we are identifying sites and talking to people about doing much larger-scale vaccination. You, of course, recognize that COVID-19 presents a challenge to the world about how you can get production to vaccinate the world. And that's the order of magnitude that we're looking at in scale. So we'll report on progress on that, but there's nothing rate limiting to our manufacturing process to get large scale.

With both flow and RSV, we explored a large scale manufacturing and we spent a lot of time developing a manufacturing process for our products that would allow us to commercialized products.

With our what their platform process and were there. We have we have good yields will in fact, we have great yields on our products. We don't normally have uncoated 19, yet, but our expectation is that it will there what we've done before which gives us both product that is can produce high scale and a region.

Will cost.

And that's our expectation so we bet we can it's it's all scandal.

And we've identified we are identifying sites in talking to people about doing much larger scale vaccination. We you you of course recognize it.

That covers an 18 presents a challenge to the world about how you can get production.

Vaccinate, the world and and that's the.

Thats the order of magnitude that we're looking at scale. So we'll report on progress on that but there's nothing there is nothing rate limiting to our manufacturing process to get large scale.

Michael Guba: Right, right. I appreciate that. You said that there's been a great deal.

Right right I appreciate that he said that there has been great meal, but not a products you'd expect to mirror that here with the others when might you know what the yield will be like here in the quarter backs.

Stan Erck: and other products. You can expect to mirror that here with others. When might you know?

Stan Erck: I will let you know what the yield will be like here in the cold impacts.

Greg Glenn: Well, I think soon. I think we'll know at sort of a small-medium scale within a couple months, and we'll be able to make projections about our capacity at that time.

Well I think soon I think I think we'll know it at a further small medium scale within a within a couple of months and be able to make projections about or capacity at that time.

I appreciate it.

Michael Guba: Appreciate it. Thanks, guys. Thank you. At this time, I'm not showing any further questions. I would like to turn the call back over to Stan Erck, President and CEO, for closing remarks.

Thanks, guys.

Thank you at this time I'm showing no further questions I would like to turn the call back over to Stan Erck, President and CEO for closing remarks.

Yeah. Thanks, very much we're it's hard to.

Stan Erck: Yeah, thanks very much. We're, we're, uh... It's hard to project the enthusiasm we have here for all of our programs now. And I think the addition of yet another program, which is the Malaria Matrix Program, is making the company a very exciting place to be. And we look forward to reporting on our progress over the next quarter.

It's hard to project the enthusiasm we have here for for all all of our programs now and then I think the addition of of yet another program, which is the malaria matrix program.

Is.

Just making company.

Very exciting place to be it and we look forward to reported on our progress over the next quarter.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

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