Q4 2019 Earnings Call

Operator: Greetings. Welcome to the Altimmune Year End 2019 Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad.

Greetings welcome to ultimately in the Air and 2019 conference call at this time, all participants listen only mode. A question and answer session will follow the formal presentation.

Got you require operator systems during the conference. Please press Star Zero on your telephone keypad. Please note. This conference is being recorded I will now turn the conference over to your host.

Monique Crossy: Please note this conference is being recorded. I will now turn the conference over to your host, Monique Crossy, with LifeSci Advisors. Thank you.

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I see with Lakeside advisors. They can you may begin.

Monique Crossy: You may begin. Thank you, Operator, and thank you, everyone, for participating in today's year-end 2019 earnings conference call. Leading the call today will be Vipin Garg, Chief Executive Officer of Altimmune. Also participating on the call will be Will Brown, Chief Financial Officer, Scott Roberts, Chief Scientific Officer, and Scott Harris, Chief Medical Officer. After the prepared remarks, we will open up the call for a question and answer session. A press release with the year-end 2019 financial results was issued this morning and can be found on the Investors page of the company's website. Before we begin, I would like to remind everyone that remarks about future expectations, plans, and prospects constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995, with a caution that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated.

Thank you operator, and thank you everyone for participating in today's year and 29 <unk> earnings Conference call.

Leading the call today will be Vipin Garg, Chief Executive Officer of ultimatum also participating on the call as well Brown Chief Financial Officer, Scott Roberts, Chief Scientific Officer, and Scott Harris, Chief Medical Officer.

After their prepared remarks, we will open up the calls for a question answer session.

A press release with a year and 29 <unk> financial results was issued this morning and can be found on the investors page of the company's website.

Before we begin I would like to remind everyone that remarks about future expectations plans and prospects constitute forward looking statement for the purposes. The safe Harbor provisions under the private Securities Litigation Reform Act of 1995.

Oh, you mean cautions that these forward looking statements are subject to risks and uncertainties that could cause actual results could differ materially.

Those indicated.

Monique Crossy: For a discussion of some of the risks and factors that could affect the company's future results, please see the risk factors and other cautionary statements contained in the company's filings with the Securities and Exchange Commission. I would also direct you to read the forward-looking statement disclaimer in our earnings release issued last night and now available on our website. Any statements made on this conference call speak only as of today's date, Friday, March 27, 2020, and the company does not undertake any obligation to update any of these forward-looking statements to reflect events or circumstances that occur on or after today's date.

For a discussion of some of the risks and factors that could affect the company's future results. Please see the risk factors and other cautionary statements contained in the company's filings with the Securities and Exchange Commission [laughter] I would also direct you to read the forward looking statements disclaimer in our earnings release discussed last night and no.

All available on our website.

Any statements made on this conference call speak only as of today's day Friday March 27 2020.

And the company does not undertake any obligation to update any of these forward looking statements to reflect the events or circumstances that occur on or after today's date.

Vipin Garg: As a reminder, this conference call is being recorded and will be available for audio rebroadcast on Altimmune's website at www.altimmune.com. With that, I will now turn the call over to Vipin Garg, Chief Executive Officer of Altimmune. Jithin, please go ahead.

As a reminder, this conference call is being recorded and won't be available for audio rebroadcast on ultimately its website at www Dot Altria dotcom.

With that I will now turn the call over took that Sungard Chief Executive officer of multiple.

Please go ahead.

Thank you money go.

Vipin Garg: Thank you, Monique. Good morning everyone, and thank you for joining us as we discuss our 2019 financial results and corporate updates. Joining me on the call today is Bill Brown, our Chief Financial Officer, who will review our 2019 financial results, as well as Scott Harris, our Chief Medical Officer, and Scott Roberts, our Chief Scientific Officer. After our discussion, we will open the call for questions and answers.

Good morning, everyone and thank you for joining us as we discuss how about 2019 financial results and corporate update.

Joining me on the Park today's Bill Brown, our Chief Financial Officer, who will review our 2019 financial results.

That's one that Scott had it off the Chief Medical Officer.

And Scott Roberts, our Chief Scientific Officer.

After a lot of discussion we will open the ballpark question then office.

Joining me today on the extraordinary circumstances.

Vipin Garg: We are joining you today under extraordinary circumstances. As of this morning, Johns Hopkins University reports more than 80,000 confirmed cases of COVID-19 in the U.S., and more than 500,000 cases worldwide. Federal and local governments are resorting to shelter-in-place and social distancing measures, affecting our day-to-day lives in a way that was unimaginable just a few weeks ago.

This morning.

Johns Hopkins University, the books more than 80000 confirmed cases up quite a bit like even the U.S.

And more than 500000 cases worldwide.

That drove that local government side. This is helping to shelter in place and social dispensing Madras affecting I would they did their lives in a way that was on imaginable, just a few weeks ago.

Vipin Garg: All businesses are affected by this pandemic with significant disruption to the workforce, clinical trials, the supply chain, and significant changes to consumer behavior and demand. This is an uncertain time, and we have taken significant steps to ensure the safety of our employees and to minimize disruption to our business. First, only our essential laboratory personnel who must be on site to continue development activities are regularly working on our premises. All other employees are working from home, and considering all the tools we have put in place to allow for this, we have seen minimal disruption.

All businesses are affected by the pandemic that significant disruption the workforce.

Clinical trials supply chain.

And the significant changes to conceal must be it yet into bats.

This is an uncertain time, and we have taken significant steps to ensure the safety or powered employees.

And to minimize disruption to our business.

But.

On the I want to Central Laboratory personnel, who must be on side to continue development activities are likely let me working on all premises.

Well not that employees up working from home and considering all the doors, we put in place to allow for this we have seen minimal disruption.

Vipin Garg: Second, as we have previously discussed, we are closely monitoring COVID-19's potential impact on our planned clinical trials. Our plans for the year include clinical trials for Nasal Shield, Hefty Cell, and ALT801. However, none of these trials have begun enrolling yet. And as these trial dates approach, we will be working closely with our CROs, clinical trial sites, and investigators to make an initial decision on a trial, to make an initiating decision on a trial-by-trial basis. Finally, as Bill Brown, our Chief Financial Officer, will discuss later, We entered 2020 with a strong cash position, which allows us the flexibility to operate during this uncertain time.

Second we are closely monitoring go but like these potential impact on all planned clinical trials.

As we have previously discussed.

Our plans for the include include clinical trials for major shield Hep B cell and all they don't want.

None of these trials have begun and Goldman yes.

And that these trial dates approach, we would be watching closely the dollar seattles clinical trial sites and investigators to make an initial decision on the trial.

Make an initiation decision on the trial by child basis.

Finally, as Bill Brown, our Chief Financial Officer will discuss later.

We had to 2020 with a strong cash position.

Which allows us flexibility to operate during uncertain times.

Now, let us talk to our cobot 19 vaccine development efforts.

Vipin Garg: Now, let us turn to our COVID-19 vaccine development efforts. Altimmune is one of several companies that is developing a coronavirus vaccine. We believe that our intranasal vaccine platform technology has the potential to offer specific and substantial benefits to address a pandemic situation, as we previously announced in February. We have created the initial vaccine in our laboratory and are working towards the initiation of a Phase I clinical trial as early as Q3 of this year. We are calling this vaccine candidate ad COVID. I would now like to turn the call over to Scott Roberts, our Chief Scientific Officer, to discuss the progress we have made with this candidate. Scott.

Oh Humulin is one of several companies that is developing although not a lot of succeed.

We believe that our interim nasal vaccine platform technology has the potential to offer specific and substantial benefits to address endemic situation.

As we previously announced in February.

We have created the initial vaccine.

You know never told me and working toward the finishing up a phase one clinical trial as early as Q3 off this year.

The following this vaccine candidate add hold it.

I would now like to done default or what the Scott Roberts, our Chief Scientific officer.

To discuss the progress we have made with this candidate.

Scott.

Thank you Justin good morning.

Scott Roberts: Thank you, Vipin, and good morning. Altimmune is rapidly progressing with the development of our single-dose COVID-19 vaccine candidate called Adcovid. Vaccine Candidate is based on the same intranasal vaccine technology used in our other clinical stage vaccine candidates, and we have significant experience in the development of intranasal vaccines for respiratory pathogens, including a seasonal pandemic influenza vaccine called Nasovar and a vaccine for inhalation anthrax called Nasal Shield. This vaccine technology is especially well suited for pandemic respiratory infections for several reasons, including the Convenient, and can be performed by ancillary health care personnel or possibly even self-administered.

All communities rapidly progressing.

The development of our single dose cope with 19 vaccine candidate called at Cooper.

Vaccine candidate is based on the same intranasally vaccine technology used in our other clinical stage vaccine candidates.

Ultimately has significant experience in the development of international vaccines for respiratory pathogens.

Including a seasonal and pandemic influenza vaccine nasal backs.

In a vaccine for inhalation anthrax called diesel shield.

This vaccine technology is especially well suited for pandemic respiratory infections for several reasons, including the fact that single dose Intranasally administration of the vaccine is simple.

[noise] convenient.

And can be performed by accessory health care personnel.

Well, even self administered.

One of the issues we face during a pandemic is that we often do not understand the biology of the new bars in particular, what type of immunity will be important for the prevention and control disease.

Scott Roberts: One of the issues we face during a pandemic is that we often do not understand the biology of the new virus. In particular, what type of immunity will be important for the prevention and control of disease? In this context, the broad activation of the immune system following a single dose of our vaccine technology, as demonstrated in our Phase 2 clinical study with nasal vacs, may be advantageous. Due to the type of vaccine technology we use, a replication-deficient adenovector system, and the fact that we administer it intranasally, we are able to stimulate not only a strong neutralizing antibody response but also T cell responses, and in Mucosal immunity is a specific type of immunity that can be established in the respiratory tract, but it requires intranasal administration to do so.

In this context, the broad activation of the immune system, calling the single dose a barbecue technology.

As demonstrated in our phase two clinical study was nasal backs maybe advantageous.

Due to the type of vaccine technology, we use replication deficient Admiral vector system.

The fact that yeah. The fact that we administer it intranasally, we're able to stimulate not only a strong neutralizing antibody response.

But also T cell responses and in particular only coastal immune response.

We caution you that he is a specific type of community that can be establishing the respiratory tract, but it requires intranasally administration to do so.

It represents the first one for defense against respiratory viruses like the one that causes Corbett 19.

Scott Roberts: It represents the first line of defense against respiratory viruses like the one that causes COVID-19. The broad immune activation of our vaccine technology means that whatever type of immunity is required to prevent infection and disease, it is likely to be stimulated by our vaccine candidate. Demonstration that a vaccine is safe and immunogenic is only one of several important requirements for an effective pandemic vaccine. Another is to be able to make, distribute, and administer the vaccine on a global scale. Here, the excellent safety stability profile of our vaccine technology, which can withstand months at room temperature without a loss in activity, is important. That level of stability may allow for distribution without refrigeration and when combined with the simplicity of intranasal administration.

The broad immune activation of our vaccine technology means that whatever type of religious required to prevent infection and disease.

As likely to be stimulated by our vaccine candidates.

Demonstration that a vaccine is safe and immunogenic, there's only one of several important werent gets written effective pandemic vaccine.

Another is to be able to major distribute and administered vaccine on a global scale.

Sure the excellent safety stability profile of our vaccine technology.

Which can withstand months at room temperature without a loss activity is important.

That level of stability, they love for distribution without refrigeration.

And when combined with the simplicity of Intranasally administration.

Scott Roberts: Several of the hurdles associated with vaccine deployment may be minimized. For example, there's been much attention given to the speed with which these vaccines can be brought to clinical testing. While speed is important, in fact, it's vital in an initial pandemic response.

Several of their earnings associated with vexing deployment, maybe minimized.

There's been much attention given to the speed with which these vaccines can be brought to clinical testing.

Well speed is important in fact, its barred in an initial nemec response, we believe that been seen attributes such as ease of administration.

Vipin Garg: We believe that vaccine attributes such as ease of administration, The number of doses required for protection, Breath of the Immune Response, including mucosal immunity, and Vaccine Stability will determine the ultimate success of the product. Shortly after the genetic sequence of the SARS-CoV-2 virus became available in late January, we designed and created the initial adcovid vaccine, expressing an optimized version of the full-length spike protein, in less than four weeks. While that vaccine is progressing forward, We are creating additional vaccine candidates that express specific portions or subdomains of the spike protein and will evaluate these vaccines, along with the full-length version for immunogenicity and animal models before selecting the best performing candidate. One advantage of our vaccine technology is that we'll be able to use the same manufacturing process for ADCOVID as we did for both Nasovax and Nasoshield, which saves critical time by avoiding most process development activity. Our Vipin.

The number of doses report for protection.

Breath of the immune response, including Bicultural community.

Indexing stability will determine the ultimate success with the product.

Shortly after the genetic sequencing the stars could be two bars became available in late January we designed to created initial Ed good vaccine expressing an optimized.

Version of the full length spiked routine.

Less than four weeks.

Well that's vaccine is progressing forward.

Great, we're creating additional vaccine candidates that express specific portions for subdue means of despite protein.

Evaluate these vaccines.

Along with the full banks version for Immunogenicity and animal models before selecting the best performing Canada.

One of the advantages of our vaccine technology is that we'll be able to use the same manufacturing process for Ed group it.

As we did for both nasal bags and these were shield.

These critical time Ive, winning most process development activities.

Our planned development path.

Put us in position to initiate a phase one safety and Immunogenicity study.

Q3, 2020 with topline data read outs in Q4.

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Thank you Scott.

Vipin Garg: Thank you, Scott. All of our employees are working very hard to advance this vaccine candidate. We believe that we have a duty to progress our vaccine development to help address this crisis. We are working collaboratively with other companies to more efficiently develop our COVID-19 vaccine candidates. We are actively engaged with the World Health Organization, the U.S. government, and other organizations. It is our belief that funding should be made available to all vaccine candidates, all viable vaccine candidates, for further testing. The problem is too great to pursue only a few candidates.

All of our employees are working very hard to advance this vaccine candidate.

We believe that you have a duty to progress our vaccine development to help address this crisis.

We are working collaboratively collaboratively with other companies do more efficiently develop our club at 19 vaccine candidate.

Got to actively engaged with the World Health organization, the U.S. government and other organizations.

He did I believe that funding should be made available to all the vaccine candidates on Bible vaccine candidates for probably the testing.

The problem is too great to pursue only a few candidates.

Vipin Garg: I would like to take a few minutes now to discuss our other clinical stage programs. Much planning and effort have been undertaken to begin trials this year. As I said earlier, we will closely monitor each of the programs as their trial dates near. That being said, I would now like to turn the microphone over to Dr. Scott Harris.

I would like to take a few minutes now to discuss our other clinical stage programs.

Much flattening an effort has been undertaken to begin trials this year.

As I said only if we were closely monitor each up the programs at their trial dates Neil.

That being said I would not unlike dipped on the microphone over to Dr. stops Harris Scott.

Thank you that them and good morning, everyone.

Scott Harris: Thank you, Vipin, and good morning, everyone. I would like to start by updating our callers on the Alt 801 program. As you are aware, Alt-801 is a potent dual GLP-1 glucagon agonist for the treatment of non-alcoholic hepatitis or NASH. The compound was acquired with the acquisition of Spitfire Pharmaceuticals by Altimmune in July 2019, in an animal study. Doctor, please check.

I would like to start by updating our callers on the all in a one program.

A few or where are all tier one is a potent dual GLP one good you're gone I get asked for the treatment of non alcoholic hepatitis or Nash.

The compound was acquired with the acquisition no split far pharmaceuticals.

Ultra meeting in July 2019.

And animal study.

That's a please check and see if you mean did your phone.

Operator: Scott, we have lost you.

But we have lost you.

Okay. His line, it's still <unk>.

Operator: Okay, his line is still... connected.

Connected.

I'll, let me turn it over to Scott Robert Scott How are you able to go through this part of discounts.

Operator: Let me turn it over to Scott Roberts. Scott, are you able to go through this part of the script?

Yes.

So in animal studies with all to either one.

Scott Roberts: So in animal studies with ALT-801. 801 was associated with weight loss of 25-40% in diet-induced obese mice and rats and returned them to a lean normal weight. In the Gubra animal model of NASH, all data one was associated with profound reductions in liver fat, improvements in the FLD activity score, normalization of L-and-N-aminotransferase, or ALT, and improved markers of liver fibrosis, all of which were superior to semaglutide and alofibranor in these models. Dr. Stephen Harrison, a noted expert in the field, commented that these were the best effects that he had observed in NASH animal models. We are completing GOP toxicology studies and manufacturing scale-up and are planning to dose our first subject in the fourth quarter of 2020. That study, which we expect to conduct in Australia, will involve a single ascending dose and multiple ascending dose cohorts of 6 weeks duration.

Oh it a one was associated with weight loss of 25% to 40% in dice diet induced obese mice and rats.

Return them to lean normal weight.

In the Guber animal model of Nash all data one was associated with profile reductions in liver fat improvements and that'll be activity scored.

Normalization of El Nino meter trends race or LTV.

And improved <unk> markers of liver fibrosis, all of which were superior to some magnetite and I love fiber Norte and these models.

Dr., Stephen Harrison noted expert in the field.

Ended that these were the best effects that he observed in Nash animal models.

Okay.

We are completing GLP tox toxicology studies and manufacturing scale up and are planning to dose our first subject into fourth quarter of 2020.

That's study, which we expect to conduct in Australia will involve the single.

Ascending dose and multiple ascending dose cohorts of six weeks duration Tom.

Hi, Scott you want.

Operator: Scott, you were, sorry, you blanked out, so Scott Roberts is reading the rest of the script. That's fine. I'll be available for questions. Perfect.

Tony You you you blanked out so Scott Roberts's reading the vast up the scrip.

That's fine I'll be available for questions.

The study will be conducted an otherwise healthy overweight and obese volunteers and data read out which is planned to occur around the in the first quarter of 2021, we expect to see significant loss of weight and reductions in liver fat validating the drug mechanisms.

Scott Roberts: The study will be conducted in otherwise healthy, overweight, and obese volunteers. At data readout, which is planned to occur around the end of the first quarter of 2021, we expect to see significant loss of weight and reductions in liver fat, validating the drug mechanism. Around that time, we plan to file an IND in the U.S. and conduct a parallel-arm 12-week Phase 1b study that will expand on these findings. Our double-blinded, placebo-controlled trial of hepatitis B is planned to enroll its first patient in the third quarter of 2020 and to read out in the fourth quarter of 2021. The study will be conducted in patients with active or inactive, chronic hepatitis B and will be comprised of six doses administered at four-week intervals. We are highly encouraged by the results of our Phase 1a trial that was completed in 2019, which demonstrated potent immunogenicity against hepatitis B proteins and an excellent safety profile, while we expect to exert. We continue to see that hefty cell is ideal for combination therapy with newer and emerging direct acting antivirals.

Around that time, we plan to file and I can be it'd be U.S. and conduct a parallel arm.

Well, we face wouldn't be study that will expand on these effects.

Our double blinded placebo controlled trials hefty so in chronic hepatitis B is planned to enroll its first patient in the third quarter of 2020.

And to read out in the fourth quarter of 2021.

Study will be conducted in patients with active or inactive.

Chronic hepatitis b.

It will be comprised of six doses administered at four week intervals.

We are highly encouraged by the results of our phase one eight trial that was completed in 2019, which demonstrated potent immunogenicity against hepatitis B proteins and an excellent safety profile.

Well, we expect to exert.

We're very logical effects in this trial, we continue to see hefty cell is ideal for combination.

Therapy, with new work and emerging direct acting in a bottles.

Finally.

Scott Roberts: Finally, we have a Phase 1 study, and the nasal shield to read out in the second half of 2020. Note that we have not begun enrollment as this trial is planned to begin in mid-Q2. With that, I'll turn it back over to Will Brown. He'll provide an update on our financials.

We have eight.

Phase one study and nasal shield to read out in the second half of 2020 note that we have not been done enrollment. This drop was planned to begin in bid Q2.

With that I'll turn it back over to will brown.

We'll provide an update on our financials will.

Yeah. Thank you Scott and good morning, everyone.

William Wood: Yeah, thank you, Scott, and good morning, everyone. On today's call, I'll be providing an update regarding our 2019 financial results. We ended the year with $37.3 million in cash and short-term investments, which is an increase year-over-year of $3 million. We have entered 2020 with a good cash position and are closely monitoring our spin-offs to maximize resources towards our program. Today, we entered into an equity distribution agreement with JMP Securities, under which we may offer and sell up to $50 million of our common stock for working capital and general corporate purposes. We also filed a prospective supplement to cover an initial offering amount under the equity distribution agreement of up to $18.9 million. We feel this is a good corporate housekeeping measure that gives us optionality in the future. As Vipin and Scott mentioned, we are closely tracking COVID-19's impact on our ability to conduct clinical trials. Considering that our trials are scheduled to start later in the year, we have the flexibility to delay programs if necessary, which will actually act to preserve our cats.

For todays call I'll be providing update regarding our 2019 financial results.

We ended the year with 37.3 billion in cash and short term investments, which is the increase year over year, a 3 million.

We had entered 2020 with a good cash position in our closely monitoring our spend to maximize resources towards our programs.

Today, we entered into an equity distribution agreement with JMP Securities under which we may offer in sell up to 50 million of our common stock for working capital in general corporate purposes.

We also filed a prospectus supplement to cover an initial offering them out under the equity distribution of a brief agreement of up to 18.9 million.

We feel this is a good corporate housekeeping measure, which gives us optionality in the future.

As dipping in Scott mentioned, we are closely tracking cobot, 19th impact on our ability to conduct clinical trials.

Considering that our trials are scheduled to start later in the year, we have flexibility to delay programs, if necessary, which will actually act to preserve our cash.

William Wood: Turning to the income statement, revenues for 2019 were $5.8 million, which is a reduction of $4.5 million compared to 2008. Our revenue was lower year-over-year, considering the large spend for a Phase I naso-shield trial in 2018, compared to primarily non-clinical work performed in 2019. Additionally, the Sparvax-L development contract was substantially completed by the end of 2018.

Turning to the income statement revenues for 2019 were 5.8 million, which they reduction of 4.5 million compared to 2018.

<unk> revenue was lower year over year, considering large Stan for phase one data show trial in 2018 compared to primarily Nonclinical work performed in 2019.

Additionally, the Sparvax L development contract was substantially completed by the into 2018.

Research and development expenses were 17.8 million for 2019 compared to 18.5 million in the same period last year.

William Wood: Research and development expenses were $17.8 million for 2019 compared to $18.5 million in the same period last year. The change year-over-year is attributable to lower clinical trial costs in 2019, compared to the prior year, offset by the recognition of $7.8 million of acquired research and development related to the acquisition of our NASH candidate, ALT801. 2019 G&A expenses of $8.5 million are $1.3 million lower than 2018 due to decreases in compensation, professional services, and legal costs offset by an increase in insurance premium. Additionally, as discussed during Q3, we recognized a $1 million impairment related to our Sparvax L-anthrax vaccine program. This represents the entire book balance of the IPR&D asset related to this product candidate, which is a legacy program acquired through the merger with Pharmatheme. Net loss attributed to common stockholders for the third quarter was $20.97 million compared to $42.5 million in the same period last year, with net loss per share equaling $1.60, versus $15.16 for 2018.

The change year over year is attributable to lower clinical trial costs in 2019.

Compared to the prior year offset by the recognition of 7.8 million of acquired research and development related to the acquisition of our Nash candidate or either one.

2019, DNA expenses of 8.5 million is 1.3 million lower than 2018 due to decreases in compensation professional services and legal costs offset by an increase in insurance premiums.

As discussed during Q3, we recognized a 1 billion dollar impairment related to our Sparvax L. Anthrax vaccine program.

This represents the entire balance of the IP R&D asset related to this product candidate, which is a legacy program acquired to the merger with pharma thing.

Net loss attributable to common stockholders for the third quarter was 20.97 million compared to 42.5 million in the same period last year with net loss per share equaling equaling $1.60.

Versus $15.16 for 2018.

With that I would like to turn I would like to open the call now for Q in a operator.

Operator: With that, I would like to turn the call over to the audience for Q&A. Operator? Thank you. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is, and you may press star 2 if you would like to remove your question from the queue. For participants and equipment, it may be necessary to pick up your handset before pressing. Our first question is from Liisa Bayko with JMP Security. Hi, I have a couple of questions for you. What is it going to cost you to bring the vaccine forward, and are you seeking outside funding? Do you have government funding where you can just... I like that.

Thank you if he would like to ask a question. Please press star one on your telephone keypad a confirmation tell indicate your line is in the question Q.

The press star to if he likes to remove your question from the Q.

Participants using speaker equipment, maybe necessary to pick up the answer before pressing the star keys.

Our first question is from Lisa Bayko, but JMP Securities. Please proceed.

Hi, a couple of questions for me one what is going to cost you to blame the vaccine cards and are you speaking outside funding do you have couple that funding I think.

Oh God class.

Yeah. So Lisa this is dependent good morning to so we are initially focused on oh developing the vaccine to up to first in man I trial. So that's really the focus and at that cost is relatively modest adept at that point, having said that we are in discussions with.

Vipin Garg: Yeah. So, Liisa, this is Vipin. Good morning.

Vipin Garg: So, we are initially focused on developing the vaccine for first-in-man trials. So, that's really the focus. And that the cost is relatively modest to get to that point. Having said that, we are in discussions with a number of non-dilutive funding sources. And, you know, we're hopeful that we'll get funding from third parties. But again, we are fully prepared to take the vaccine forward on our own because the costs are fairly modest. So we'll continue to work with potential funders but move forward full speed ahead and fund it on our own.

The number, though but bomb dilutive funding sources and well you know we're hopeful that we've got the funding from third parties to develop this for them.

But again, we are fully prepared to take the vaccine followed on out on because the cost a fairly fairly modest so what a continued to work with the potential from doses, but let's.

Move forward full speed ahead and funded on out on <unk>.

Vipin Garg: Can you talk about timelines from here, let's say, all the way through to having this on the market? What are we talking about?

Can you talk about sort of timelines from here, let's say all the way through too you know haven't with on the market.

What are we talking about.

Vipin Garg: Yes, as you can imagine, timelines are hard to predict because it is all going to depend upon what kind of attitude the FDA will take. In terms of accelerating and expediting the development of these vaccines, everything that we have seen so far is sending us very positive signals. The FDA has been very accessible to us as well as to other companies, so we've had a very good dialogue with them. The question is going to be, once we show the first in human efficacy or immunogenicity, what's the, you know, how good is that immunogenicity and how comfortable people feel. And from a manufacturing perspective, as Scott Roberts pointed out, we have a lot of experience. So we can really expedite things in terms of manufacturing large amounts of the vaccine, as well as from a safety perspective, we can provide a lot of comfort to the FDA, and we have a lot of safety data. Let me turn it over to Scott Roberts.

Yes that you can imagine a timeline so hard to predict because it's all it is all going to depend upon what kind of vascepa DFT it will take the.

Intensified accelerating in expediting the development up these up vaccines. So everything that we're seeing so far is sending us made positive signal.

DFT has been very accessible to us as well, let's do other companies. So we've had a very good dialogue with them or the question is going to be once we show a the first in human efficacy and Immunogenicity. What's the you know how did that immunogenicity and how comfortable are people feel.

To sort of either do it I did give an emergency use authorization or some kind of stockpiling orders at that point, so not all of the old lose up drug development I really not applicable here, we just have to see how things develop the but it is flight conceivable that you've been shows.

Good Immunogenicity and relatively good safety that we'll be able to begin stockpiling and manufacturing large amounts of vaccines far like human use so we could be as early as early next year. If all of that comes together one of the things I would point out about our vaccine platform is that they have already.

Oh look the D.F.D. and have developed it to other vaccine candidates using exactly the same let's say in platform technology. So from a safety perspective, you have lot of information.

On the manufacturing perspective as Scott.

Scott Roberts: Well, I think...

Scott Roberts pointed out we have lot of Expedia. So we can really exabyte thing and themselves manufacturing large amounts of the vaccine as well as stem from a safety perspective, we can thrive in lot of comfort to be F.D., and we have not of safety data, let me down it, though what the spot, Rob, but Oh and wood.

Vipin Garg: I was a very good expert.

Vipin Garg: Vipin. What I would add is that with the platform technology and our experience with it, we're also able to bypass the toxicology studies that would normally be expected. That's our experience. We've leveraged the toxicology and safety data for one product for another previously, and we expect to be able to do so successfully with the ad COVID. So with all those factors coming together, familiarity with the platform technology, and the types of vaccine attributes that we've talked about on the call here today, I think we're in a good position.

Up to he had his talks on this.

Well I think that was a very good explanation of the situation dip and Oh, what I would add is that a with the platform technology in our experience with it. We're also able to bypass the toxicology studies that would normally be expected, though that's something that's our experience we've we've.

Leveraged Oh, the toxicology and safety data for one product for another previously and we expect to be able to do so successfully with the AD coded so with all those factors come together familiarity with the platform technology.

Vipin Garg: Where does that put you in terms of timing vis-a-vis some of the other programs that are moving forward for vaccines? Are you kind of in the middle of the pack, or are you ahead of people, because, again, you mentioned you have some... I have quite a bit of experience in this area already.

And the type so Bob vexing attributes that we've talked about on the call here today I think we're in a good position.

Does that where does that put you in terms of timing viz, a viz some of the other.

Programs that are moving forward for vaccine I kind of in the middle APAC knew how to people. Because again you know you mentioned you have some ball quite a bit of expenses there already.

Vipin Garg: Yeah, I think, you know, with the whole, not a whole lot of specific clarity except for, you know, the, the, very, very

John than others.

Yeah, I think you know what's up there's really a whole not a whole lot of oh, but specific clarity except for you all did that day and a very early MRT technology that somebody that into the clinic, the others, a everybody, saying up and that they can move quickly but.

Vipin Garg: Early MR

Scott Roberts: Everybody's saying that they can move quickly, but I think that our technology, the fact that we're able to create the initial vaccine candidate within four weeks and provide additional candidates now puts us in very good stead with respect to speed. But as I pointed out in the discussion earlier, speed is important, but it's not the most critical factor. At least that's our belief that overall, the vaccine attributes, such as the ease of administration, and the number of doses required. And that's an important point. A lot of the technologies that are being developed are going to require more than one dose. And if you think about that on a scale of millions or more people, that becomes a logistical issue to get people back after a month, and it also delays the time at which they'll be protected from infection. So there are a number of attributes that, in the long run, will probably be more important than how quickly one gets to a Phase I study.

No I think that our technology, but the fact that we're able to agreed the initial vaccine candidate within four weeks in providing additional candidates now.

Success, it very good stead with respect to speed, but as I pointed out into discussion earlier speed is important but it's not the most critical factor at least that's our belief that overall the vaccine attributes such as the ease of administration. The number of dose is required and that's an important point a lot of the technologies that are being.

Developed.

Going to require more than one dose.

And if you think about that all the scale of millions or or more.

People that becomes a logistical issue and to get people back after a month and it also delays at the time, which they'll be a protected from from a infection.

So there are number attributes that are in the long one will probably be more important than how quickly when it gets the phase one study.

Okay. Thank you and then just.

Liisa Ann Bayko: Okay, thank you. And then just, um... As a background, where do you manufacture your vaccine? Can you maybe walk us through the supply? values?

Background, where where do you manufacture your vaccine, but can you maybe walk us just like you.

[noise] values.

Scott Roberts: Hughes.

Scott Roberts: Yeah, we use commercial manufacturing organizations. We have strong relationships with a number of them.

Yeah, we use so.

Commercial manufacturing organization. So we have a strong relationships with a number of them the advantage of using organizations that have familiarity with the with the processes is important and that allows us again to expedite the de risk that a that critical step up producing the clinical trial material I think that.

Scott Roberts: The advantage of using organizations that have familiarity with the process is important, and that allows us again to expedite and de-risk that critical step of producing the clinical trial material. I think that upon demonstration of immunogenicity and safety, the ability to scale and manufacture a vaccine such as ours at COVID globally is quite straightforward. This has been done at a very large scale by large pharma in the past. The process is very simple. It's bioprocessing 101, and so to be able to do tech transfer to multiple manufacturing sites globally to supply enough vaccine would be a straightforward proposition.

Upon demonstration of Immunogenicity and safety or the ability to scale and manufacture a vaccines such as our hours that go get a globally is is is quite straightforward. Oh. This has been done at very large scale by a by a large pharma in the past.

The process is a very simple, it's it's bioprocessing want a one and so I'd be able to do tech transfer to multiple manufacturing sites globally to supply.

The effect seen a would be straightforward proposition.

Okay. Thank you Manny, though in terms of location at the global.

Liisa Ann Bayko: Okay, so in terms of location, it's global.

Liisa Ann Bayko: It would need to be global if a successful vaccine is moving forward towards deployment. And in the near term, is it something that's done more in the U.S. domestically?

It would need to be global after the successful vaccine is moving forward towards towards that and in the near term is it something that's done luck Mark you know it in the U.S. domestically or where are you starting locally right now or we do our manufacturing in the U.S. currently, but we are evaluating all possibilities.

Liisa Ann Bayko: Where are you sourcing those from?

Scott Roberts: All right, we'll do our manufacturing.

Liisa Ann Bayko: Okay, and then just a strategic question for you, Vipin. You know, it seems like maybe this is taking a bit of the front seat for now. Is that the right way to characterize your efforts? Or is your NASH program still kind of the number one priority? How do we think about your efforts?

Okay, and then just I guess, a question strategically for or you've got Ben.

You know it it seems like baby doesn't taking up because of the front seat for now is that the right way to characterize your efforts or.

Is your Nash program, so it kind of a number one priority how do we think about.

Well I don't look clearly clearly lease that we have to respond to this crisis. We believe we have that.

Vipin Garg: Clearly, Liisa, we have to respond to this crisis. We have a very attractive technology platform that's ideally suited for upper respiratory pathogens like COVID-19. Because I just want to remind everybody that ours is not only a single dose, but it's the only intranasal vaccine in development. And that's really important because we are actually delivering the vaccine exactly where the virus enters the human body. So, as Scott pointed out, our vaccine has this special kind of immunity that no other vaccine has, which is called mucosal immunity. And this really provides a barrier, you know, at the site of entry, where the virus enters the body. So we think that it could have this extra advantage there. So given this technology platform, I mean, we've always said within the company that our technology is really created for pandemic response. And that's, you know, so this, you know, we have to respond to this challenge because the technology fits so well with some of the attributes that you would be looking for in a pandemic vaccine. So as a result, you know, we put a lot of focus and a lot of effort into that.

We have a very attractive technology platform that is ideally suited for the upper respiratory pathogens like public 19, because I just want to remind everybody that that ours is the on the not only to single dose, but it's the on the internet the vaccine development.

And that's really important because oh, we got actually delivering the vaccine exactly where the vida and just the human body. So adds as Scott pointed out our vaccine or has the especially kind of community that no. Other vaccine has which is called the mucosal immunity and it's really provides the best.

Yes, you know at the site to entry.

With the vital santas the body. So we think that you could have this extra advantage fast so given this technology platform I'm involved they said they didn't but company that all of technologies really created for pandemic response, and that's you know so this you know we have to respond to this challenge because the technology fits.

So well with some of the attributes that you would be you would be looking for quite a pandemic vaccine. So as a result, you know we put a lot of focus lot of African that as far as out Nash program. All data one with a very excited about that and that's moving fall, but Oh I got made the shield programming is ready to go into the clinic. So.

Vipin Garg: As far as our NASH program, All Data One, we're still very excited about that, and that's moving forward. Our Nasal Shield program is ready to go into the clinic. So everything is, you know, we outsource everything. So it's not like we're manufacturing these things in-house. So our R&D team is totally focused on COVID-19, but we have other people in the company in terms of regulatory planning, in terms of getting ready for the clinical trials and putting everything in place. The All Theta One program is, the manufacturing is going on at a third-party location as well as preclinical testing. So all of those things, we have not slowed down any of our activities at this point, but we are monitoring. The good news is that most of our trials are going to be a little bit later in the year.

So everything gets you know we outsourced everything so it's not like their manufacturing these things in house so.

So how about R&D team is totally focused on a on a covered 19, but can we have other people in the company in terms of regulatory planning in terms of getting ready for the clinical trials and putting everything plays.

The the all data one program is is the manufacturing is going going on that that talk bhakti location as well as sets a preclinical testing. So all of those things we've not slowed down any allowed activities at this point.

But we are monitoring the good news is most of our trials are going to be little bit later on in the year clearly that could impact us depending upon what happened. So how long that's just a pandemic lost but for now out everything is still on time and and we can move forward with covered 90 in addition to others.

Vipin Garg: Clearly, it could impact us depending upon what happens or how long this pandemic lasts. But for now, everything is still on time, and we can move forward with COVID-19 in addition to other programs that we have within the company. As you know, we have a strong cash position so we can fund these programs and move them forward. So I think we're well positioned right now to keep everything moving. Moving forward, but we'll clearly make that decision as we move forward. As we see

Program. So that you have within the company as you know we have a strong cash position. So we can fund these programs and a and move them fall, but so I think about developed position right now to keep everything will be.

Moving fall, but what we've clearly make that decision as we move forward.

Yeah, I think that we see the see the impact of the pandemic.

Vipin Garg: Excellent. Thank you for all the good work you're doing. Thank you. As a reminder, if you would like to ask a question, it is star one on your telephone keypad. We will pause for a brief moment to poll for questions. There are no more questions at this time. I would like to turn the conference back over to management for closing remarks.

Excellent. Thank you for all the good work you're doing.

Thank you.

As a reminder, if he would like to ask a question. It is star one I knew telephone keypad, we will pause for a brief moment to poll for questions.

There are no more questions at this time I would like to turn the conference back over to management for closing remarks.

Well. Thank you everyone for listening in today, we look forward to speaking to you again on our next earnings call. Thank you.

Vipin Garg: Well, thank you everyone for listening in today. We look forward to speaking to you again on our next earnings call. Thank you.

Operator: Thank you. This concludes today's conference. You may disconnect your lines at this time, and thank you for your participation.

Thank you. This concludes today's conference you may disconnect your lines at this time and thank you for your participation.

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