Q2 2020 Altimmune Inc Earnings Call

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This time all participants are in 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.

Operator: 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 tone. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Ms. Monique, and for Best Relations for Altimmune, you may... Thank you, Melissa, and thank you, everyone, for participating in today's Q2 2020 Earnings Conference Call. Leading the call today will be Dr. Vipin Garg, Chief Executive Officer of Altimmune. Also participating on the call today are 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 Q2 2020 financial results was issued last night and can be found on the investor page of the company's website.

As a reminder, this conference is being recorded I would now like to turn the conference over to your host Ms. money coffee Investor Relations for all to me you may begin.

Thank you Melissa and take you everyone for participating in todays Q2, 2020 <unk> earnings conference call.

Leading the call today will be Dr. guessing guard Chief Executive Officer, Baltimore also participating on the call today's Bill Brown, Chief Financial Officer, Scott Roberts, Chief Scientific Officer, Scott Harris, Chief Medical Officer.

After their prepared remarks, we will open up the call for question and answer session.

A press release with the Q2 2020 financial results was issued last night 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.

Monique: 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. Altimune cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated, including those related to COVID-19 and its impact on our business operations, clinical trials, and results of operations. 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.

Oh could mean cautions that these forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated including those related to cope with my team and its impact on our business operations clinical trials and results of operations.

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.

I would also direct you to read the forward looking statement disclaimer in our earnings release issued last night and no [laughter] available on our website.

Monique: 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, Wednesday, August 12, 2020. And the company does not undertake any obligation to update any of these forward-looking statements to reflect events or circumstances that occur after or on today's date.

Any statements made on this conference call speak only as of today's date Wednesday August 12 2020.

The company does not undertake any obligation to update any of these forward looking statements treats what events or circumstances that occur after.

On today's date.

As a reminder, this conference call is being recorded and will be available for audio rebroadcast on all to means website www dot all to mean dot com.

Monique: 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. Vipin, please go ahead. Thank you, Monique.

With that I will now turn the call over to Vipin Garg, Chief Executive Officer vault.

Please go ahead.

Thank you money.

Good morning, everyone and thank you for joining us as you just got solid Q2, 2020 financial results and corporate update.

Vipin Garg: Good morning everyone, and thank you for joining us as we discuss our Q2 2020 financial results and corporate updates. Joining me on the call today is Bill Brown, our Chief Financial Officer, who will review our Q2 financial results, as well as Scott Roberts, our Chief Scientific Officer, and Scott Harris, our Chief Medical Officer. After our discussion, we will open the call for Q&A.

Joining me on the bulk today, it's bill Brown, our Chief Financial Officer, who will review our Q2 financial results.

And then Scott Roberts, our Chief Scientific Officer.

And Scott status, our Chief Medical Officer.

After our discussion we will open the call Fucked USA.

The first half of 2020 has been transformational people ought to be on.

Vipin Garg: The first half of 2020 has been transformational for Altimune, and I'm very pleased with our progress today. We have made significant strides toward developing two product candidates to address the COVID-19 pandemic, a highly differentiated intranasal vaccine and a novel immunomodulatory therapeutic candidate. We secured additional government funding and capitalized the company sufficiently to fully lean into the challenges that lie ahead of us, outside of COVID-19. We continue to push forward aggressively on our other product candidates.

I'm very pleased that all progress to date.

We have made significant strides towards developing two product candidates to address to cope with 19 pandemic.

The highly differentiated intranasally vaccine.

The novel immuno Modulatory kind of give the candidate.

We secured additional government funding.

Capitalize the company sufficiently.

Fully lead into the challenges that lie ahead of us.

Outside of corporate 19, we continue to push forward aggressively on our other product candidates.

We have recently completed enrollment in our neither shield.

Vipin Garg: We have recently completed enrollment in our Nasal Shield anthrax vaccine trial, and we are on track to begin an ALK801 first-in-human NASH trial in Q4. We also had a successful IND submission for our chronic hepatitis B therapeutic hep T cell, which is slated for a Phase II trial to begin later this year. With these advancements, we are well-poised to deliver shareholder value throughout 2020 and beyond. With that in mind, I would like to spend a few minutes on our areas of focus for the remainder of this year.

It's vaccine trial and be out on track to begin.

Eight to one.

First in human Nash trial in Q4.

We also had a successful I in decent shape put all chronic hepatitis b.

D. so.

That is slated for the phase two trial to begin later this year.

These advancements we about boys deliver shareholder value throughout 2020 and beyond.

With that backdrop I would like to spend a few minutes on out areas of focus for the remainder of this year.

But.

Do you have focused on expeditiously moving at Goldman Sachs.

Vipin Garg: We are focused on expeditiously moving COVID towards an IND and a phase one clinical trial in Q4. We look forward to building on ADCOVID's outstanding preclinical data by moving it into the clinic as quickly and safely as possible. We are pleased with robust mucosal and systemic immunity observed in preclinical studies conducted by our collaborators at the University of Alabama at Birmingham. We have simultaneously forged alliances with several manufacturing partners to secure clinical trial material and began that process in July. Scott Roberts, our CSO, we'll discuss that momentarily.

So what's the nine be under phase one clinical trial in Q4.

We look forward to building on AD overage outstanding preclinical data.

By moving it into the clinic as quickly and safely as possible.

We are pleased with robust mucosal and systemic you'd be energy observed in preclinical studies conducted by our collaborators at the University.

Alabama Birmingham.

We have simultaneously forced alliances with several manufacturing box office to secure clinical trials material and begun that process in July.

Scott, Rob Rob our CFO will discuss momentarily.

These activities are going well.

Vipin Garg: These activities are going well, and we remain on track to begin our phase one clinical trial later this year. [inaudible] We continue to pursue non-dilutive funding for ADCOVID. As previously announced, we entered into a branding agreement with Dynaport Vaccine Company, or DVC, to pursue federal and non-profit funding.

And we remain on track to begin our phase one clinical trial later this year.

Second.

We continue to pursue non diluted funding at gold it.

As previously announced.

We entered into a teaming agreement the dyncorp vaccine company or D.V.C.

To pursue that drawn to nonprofit funding.

Before we see a general dynamics information technology company has extensive experience in vaccine development and has been the prime contractor.

Vipin Garg: BBC, a general dynamics information technology company, has extensive experience in vaccine development and has been the prime contractor and systems integrator for many government projects. The partnership with DVC significantly expands Altimmune's capabilities to execute on government funding opportunities and accelerate the development of Adcovid.

And systems integrator for many government projects.

The partnership the D.V.C. significantly expands ought to be landscape abilities to execute on government contact on government funding opportunities.

And accelerate the development of absolutely.

Hello.

We remain focused on executing the teco bit trial.

Vipin Garg: During the second quarter, we announced not only that we had created a new program based on RespirVac, our replication deficient adenovirus 5 platform, but that the Department of Defense awarded Altimmune $4.7 million to fund the EPIC trial, our phase 1-2 clinical trial of T-COVID, and the Prevention of Clinical Worsening in COVID-19. We're especially excited about this program, as it represents a novel mechanism with tremendous promise.

And maintaining deal de support.

During the second quarter.

We announced not only that we had created a new program based on that's been a back how's application deficient at Novartis five platform.

But that the department of defense awarded ought to be on.

$4.7 billion.

To fund the epic trial, our phase one that's two clinical trial of de called it the prevention of clinical worsening in covert 90.

We especially excited about this program.

This represents in novel mechanism the tremendous promise.

And we had one of the few therapeutics intended to stop the progression of R&D called it might be just to be able to seize that hospitalization.

Vipin Garg: And we are one of the few therapeutics intended to stop the progression of early COVID-19 to severe disease and hospitalization. We are working very closely with our colleagues at the U.S. Army Medical Research and Development Command on this program, and as Scott Harris, our CMO, will more fully discuss.

We have working very closely with our colleagues at the U.S. Army Medical research and development command on this program.

Scott Hi, this our CMO will more fully discussed.

We look forward then go during our first patient imminently and delivering top line data readout from this trial in Q4 off this year.

Vipin Garg: We look forward to enrolling our first patient imminently and delivering top-line data readout from this trial in Q4 of this year. I would now like to turn the call over to Scott Roberts, our CSO, who will fully update you on the progress we have made with ADCOVID, and then Scott Harris, who will discuss our clinical plans across our portfolio.

I would now like to dawn default or what to Scott's Roberts our C.S. So.

Who would fully update you on the progress we've made good at school that.

And then Scott Hedis, who will discuss our plan for plans across our portfolio Scott Roberts.

Thank you Susan and good morning.

Scott Roberts: Thank you, Vipin, and good morning. We have made excellent progress toward our phase one clinical trial of ADCOVID. Single Dose Intranasal Vaccine Candidate for COVID-19. Earlier this year, we created different vaccine candidates based on a RespirVac replication-deficient adenovirus vaccine platform. Expressing different portions of the viral spike protein, were evaluated in a series of preclinical studies performed by our collaborators at the University of Alabama at Birmingham.

We have made excellent progress.

Toward our phase one clinical trial, a bad coated.

A single dose Intranasally vaccine candidate for Cobot 19.

Earlier this year, we create a different vaccine candidates based on a rest for back replication deficient and no burris vaccine platform.

Candidates.

I see different portions of the virus like protein.

Revaluate isn't a series of preclinical studies performed by our collaborators at the University of Alabama.

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Based on those results we selected the candidate that expressed the receptor binding domain RBC.

Scott Roberts: Based on those results, we selected the candidate that expressed the Receptor Binding Domain, or RBD, of this viral spike protein for clinical development. The RBD is essential for viral infection, and the great majority of neutralizing antibodies in convalescent sera are directed against the RBD, so it's clearly an important target for the immune system. In our preclinical mouse studies, a single intranasal dose of adcovid stimulated strong serum antibody responses and high virus neutralizing titers. Importantly, COVID also induced a very robust mucosal IgA antibody response in the respiratory tract. Mucosal IgA is a special type of immunity that is produced locally to provide local protection from infection. When stimulated in the respiratory tract, mucosal immunity offers the potential to not only block infection but also prevent the spread of the disease and block transmission of the virus to others.

Of this virus spike protein for clinical development.

The RV D is essential for viral infection and the great majority of neutralizing antibodies and convalescence zero are directed against the RV D. So it's clearly an important target for the immune system.

You know preclinical most studies.

Single international dose of bad.

Stimulated strong serum antibody responses at high virus neutralizing tires.

Fortunately it could also produced a very robust mucosal <unk> antibody response in the respiratory tract.

Mucosal geared it's especial type of community that has produced locally to provide local protection from infection.

What stimulated in the respiratory tract mcauslan going to do offers potential to not only block infection, but also block transmission of the virus daughters.

By far the most important way to induce a nasal I'd you gave response is to administer the vaccine intranasally.

Scott Roberts: By far the most important way to induce a nasal IGA response is to administer the vaccine intranasally. However, bear in mind that all of the vaccine candidates in advanced clinical testing are delivered by intramuscular injection. Not only is that method of dosing more complicated than intranasal dosing, but it's also unlikely to elicit mucosal IgA immunity in the respiratory tract. The presence of nasal IgA may be especially important for protection from COVID-19 because of two important considerations. One, The SARS-CoV-2 virus replicates well in the nasal cavity, and two antibodies against the virus that are in your blood can't get into the nasal cavity very well.

Bear in mind that all of the vaccine candidates and advanced clinical testing, our deliberate body intramuscular injection.

Not only is that not set up dosing more complicated than it for nasal dosing.

It's also unlikely to elicit mucosal Archie immunity and the respiratory tract.

The presence of names like.

Maybe especially important for protection from Corbett 19, because of two important considerations.

One.

Sorry to be two bars replicates well in the nasal Kathy.

In two.

Antibodies.

Since the virus that are in your blood shifted into the nasal can be very well.

So in the absence of local the pool, so our AG immunity.

Scott Roberts: So, in the absence of local mucosal IgA immunity... the nasal cavity may become a safe haven for the virus. Over the next few weeks, we'll be reporting on the ability of ADCOVID. A third type of immunity that we expect to stimulate, in addition to the neutralizing antibody, is the mucosal IgA response. Once we have the T cell data in hand, we plan to quickly publish the preclinical data so we can share it with the scientific community. Now, having identified the vaccine candidate we are taking forward, we initiated a dual-track approach toward the manufacturing of ADCOVID while moving quickly to provide clinical trial material to conduct our Phase 1 trial later this year. We will begin scaling the manufacturing process in parallel to meet the requirements of phase three testing and the commercial launch of ADCOVID.

Nasal cavity may become a safe haven for the bars.

Over the next few weeks, we'll be reporting on the ability of had good to stimulate CISO community.

Third type of community, we expect to stimulate in addition to the neutralizing antibody them because like you gave responses.

Once we have the T cell didn't.

We plan to quickly published preclinical data.

We can sure what's a scientific community.

No.

Having identified the vaccine candidate we're taking Ford.

We initiated a dual track approach towards the manufacturing or that Google.

Well moving quickly to provide clinical trial material to conduct our phase one trial later this year.

We will begin scaling the manufacturing process in parallel to meet the requirements of phase three testing in commercial launch bad.

To accomplish these aggressive goals, we have established multiple alliances with key manufacturing partners that have deep experience in the manufacturable vectors.

Scott Roberts: To accomplish these aggressive goals, we have established multiple alliances with key manufacturing partners that have deep experience in the manufacturing of viral vaccines. Notably, we are using the same manufacturing process for ADCOVID as for other vaccine candidates, including our nasal shield intranasal anthrax vaccine that we are developing with BARDA and Nasalvax, our intranasal influenza vaccine. Using the same manufacturing process allows us to manufacture quickly and with confidence.

Notably.

We are using the same manufacturing process for Ed cope it it's were observed vaccine candidates, including our nasal shield Intranasally anthrax vaccine.

We are developing with BARDA.

And nasal backs or intranasally influenza vaccine.

Using the same manufacturing process allows us to manufacture quickly in Wisconsin is.

Additionally.

Scott Roberts: Additionally, vaccine candidates based on our RespirVac platform have shown excellent stability at room temperature, potentially allowing for the distribution of adcovid without the refrigeration or freezing that is normally required for other vaccines. Greatly simplifying getting the vaccine to those who need it. With that... I will turn the call over to Scott Harris, who will provide a clinical update on our programs.

So candidates based on a rest perfect platform have shown excellent stability at room temperature potentially allowing for the distribution of bad scoop it without refrigeration or freezing that is normally required for other vaccines greatly simplifying getting the vaccine to those who need it.

With that.

I will turn the call over to Scott Harris, who provide a clinical update on our programs Scott.

Thank you Scott and good morning, everyone.

Scott Harris: Thank you, Scott, and good morning, everyone. Continuing with the AddCOVID program, we expect to file the IND and launch the phase one clinical trial of ADCOVID in the fourth quarter of 2020. This trial will include approximately 120 subjects, and while our preclinical studies and clinical trial data from our other intranasal replication-deficient adenovirus vaccine trials have not suggested the role of a prime boost. We nonetheless plan to evaluate the effects of one and two doses of vaccine to confirm this hypothesis. Immunogenicity analyses will include total serum IgG. Neutralizing Antibodies, Nasal, Mucosal Immunity, and T-Cell Responses. We anticipate data readout for the trial in the first quarter of 2021 and launch a phase two trial on the heels of this readout. Based on the preclinical findings discussed earlier, prior experience with or other intranasal vaccine, we expect potent responses in all aspects of immunity and for ad COVID to be safe and well tolerated with adverse events and reactogenicity events similar to placebo.

Continuing with our with the I'd could program, we expect to file be R&D.

And launched a phase one clinical trial of I'd call that in the fourth quarter of 2020.

This trial will include approximately 220 subjects and wall or preclinical studies in clinical trial data from our other intranasally replication deficient I know five virus vaccine trials have not suggested the role for prime boost we nonetheless plan to evaluate the effects of one.

In two doses of vaccine to confirm this hypothesis.

Immunogenicity analyses will include total Sera Archie JV.

Otherwise the anybodys nasal mucosal immunity and T cell responses.

We anticipate the data read out for the trial in the fourth in the first quarter of 2021.

And launch a phase two trial on the heels this readout.

Based on the preclinical findings discussed earlier.

Prior experience with or other intranasally vaccines.

Expect potent responses in all aspects of immunity and FERC I feel good to be safe well tolerated.

With adverse events and react to June this city event similar to placebo.

We also previously announced that we were awarded $4.7 million by the a U.S. Army Medical research and development command.

Scott Harris: We also previously announced that we were awarded $4.7 million by the U.S. Army Medical Research and Development Command to fund the entire cost of conducting a clinical trial with T-COVID. This trial will be known as the EPIC trial or the efficacy and safety of T-COVID in the prevention of clinical worsening in COVID-19. We've completed all of the government contracting processes and institutional reviews, and clinical sites are now active, with enrollment expected to commence imminently. TCOVID is an immune modulator for pulmonary viral infections and is differentiated from most other COVID-19 therapeutics in development as it is focused on non-hospitalized patients prior to the development of pulmonary dysfunction and the need for hospitalization because of the broad protection T-COVID could afford against a variety of other respiratory pathogens.

To fund the entire cost of conducting a clinical trial with T code.

This trial will be known as the epic trial.

For the efficacy and safety of T code bid in the prevention of clinical worsening in coated 19.

We have completed all the government contracting processes and institutional reviews and clinical sites are now active.

With enrollment expected to commence imminently.

She cove it is an immune modulator for pulmonary viral infections and this differentiated for most other code that 19 therapeutics in development.

It is focused on non hospitalized patients prior to the development in the Pullmantur dysfunction.

And the need for hospitalization.

Because of the broad protection to covert could afford against a variety of other respire Tory pathogens. We believe it could be use a defensive defend against future Saints strains of krona virus or other pandemics.

Scott Harris: We believe it could be used to defend against future strains of coronavirus or other pandemics. Data readout from this trial is expected in the fourth quarter of 2020, and if successful, we plan to initiate a Phase II-III trial early next year and commence discussions regarding emergency use authorization. We recently announced that we completed enrollment in our Phase 1B trial of MaserShield for Anthrax and expect data readout on target in the fourth quarter of 2020. If NasoShield is shown to be safe and effective...

Data readout from this trial is expected in the fourth quarter or 2020, and if successful we plan to initiate a phase two three trial early next year and commenced discussions regarding emergency use authorization.

We recently announced that we completed enrollment in our phase won't be troll days or shield for anthrax.

Then expect you to read out on target in the fourth quarter 2020.

If need so shield to shown to be safe and effective.

Remaining options over 133.7 million dollar contract with BARDA could be awarded to complete phase two clinical testing and begin stockpiling of news or shield in this strategic reserve.

Scott Harris: The remaining options of our $133.7 million contract with BARDA could be awarded to complete Phase II clinical testing and begin stockpiling of NasoShield in the Strategic Reserve. We also remain on track with IND-enabling studies and manufacturing to commence dosing in our first in-man clinical trial for ALT801, our GLP-1 glucagon dual agonist for NASH, in Australia in the fourth quarter of this year. We expect to have a readout on body weight, loss, and reduction in liver fat, toward the end of the first quarter of 2021.

We also remain on track with all you need the enabling studies in manufacturing to commenced dosing and her first in man clinical trial for all it'll one [noise].

Our GLP one looking gone dual arguments for Nash in Australia in the fourth quarter of this year.

We expect to have a read out on body weight.

Loss and reduction in liver fat [noise] toward the end the first quarter of 2021.

It will be a value driving event for investors as it will place also it'll one squarely in the forefront of Nash development.

Scott Harris: This will be a value-driving event for investors as it will place Alt-801 squarely in the forefront of NASH development. We expect ALT801 to be better tolerated than similar therapies and achieve weight loss and improvement of liver fat in the Phase I trial without the need to dose titrate for GI intolerability, which has impacted the GLP-1 development space. At the conclusion of this first inhuman trial, we plan to file an IND in the U.S. and initiate a 12-week trial in patients with non-alcoholic fatty liver disease. We expect data readout on this trial in the third quarter of 2021, and a transition rapidly to full Phase IIb. IBSI-based trial based on NASH endpoints by the end of 2021. Pending the results of the first in-human trial, we may also elect to initiate a separate program for the treatment of obesity. We feel confident that the efficacy and pharmacokinetic profile of Alt-801 in preclinical studies will translate to improved weight loss and tolerability with more potent effects on weight loss and reduction in NASH activity compared to other agents.

We expect all it'll wanted to be better tolerated and similar therapies and achieve weight loss and improvement of liver fat in the phase one trial without the need to dose titrate Fuji I'd, Intolerability, which has impacted the GLP one development space.

At the conclusion of this first in human trial, we plan to fall in R&D in the U.S. and initiate a 12 week trial in patients with non alcoholic fatty liver disease.

We expect to data read out on the stronger third quarter of 2021.

And they transition rapidly to a full phase to be <unk>.

Biopsy.

Based a trial are based on Nash endpoints by the end of 2021.

Pending the results of the first in human trial, we may also elect to initiate a separate program.

In the treatment of obesity.

We feel confident that the efficacy in pharmacokinetic profile up altera, one in preclinical studies will translate to improve weight loss and tolerability with more potent effects on weight loss and reduction in Nash activity compared to other agents.

Finally, we successfully filed the R&D for Hep T cell or chronic hepatitis b immuno therapeutic.

Scott Harris: Finally, we successfully filed the IND for hep T cell or chronic hepatitis B immunotherapeutic. The Phase 2 trial is designed to evaluate the antiviral activity of Pepti cells in chronically infected patients and is an important milestone in our goal to develop a functional cure for this disease. Depending on the patient population being treated, the immunotherapeutic mechanism of PEPT cell is intended to work alone or in combination with new antiviral therapeutics that are being developed for this disease.

The phase two trial is designed to evaluate the into viral activity of Pepsi. So in chronically infected patients as an important and is an important milestone in our goal is to develop a functional cure for this disease.

Depending on the patient population being treated immunotherapeutic mechanism, but pep t. So is it tended to work alone or in combination with the new antibody therapeutics that are being developed for this disease.

We expect to initiate enrollment in the fourth quarter of 2020.

Scott Harris: We expect to initiate enrollment in the fourth quarter of 2020, pending evaluation of the impact of the COVID-19 pandemic. And with that, I'll turn things back over to Vipin Garg.

Pending evaluation of the impact of the <unk> 19 pandemic.

And with that I'll turn things back over to Vipin Garg [laughter].

Thank you Scott <unk>.

Vipin Garg: Thank you, Scott. As you may have noticed from Dr. Harris's remarks, it is important for us to continue the development of our portfolio outside of COVID-19, in addition to developments with ad COVID and tCOVID. We expect to have a data-rich time period over the next 12 months, with data readouts from NasoShield in our Anthrax trial, ALT-801 in our NAS trials, and the initiation of a chronic hepatitis B trial with hepatitis cells. One of the key tenets of our philosophy is to have multiple shots on goal, and we look forward to sharing the results of these clinical trials Thank you, Vipin, and good morning, everyone. On today's call, I'll be providing an update regarding our second quarter financial results. Our cash and short-term investments balance was $80 million at June 30th, for an increase of $47 million since the first quarter.

You may have noticed from Dr. had his remarks. It is important for us to continue the development of our portfolio outside of course with 19.

In addition to developments with adequate and people get.

We expect to have a date after each time period over the next 12 months with data read outs from Linzess Yoked, you know what anthrax trial, all eight to one did our Nash trials and they need situation or for chronic hepatitis B trial could have de Sal.

The key tenets of our philosophy is to have multiple shots on goal.

And we look forward to shading the results of these clinical trials as they become available.

Did that I've done to follow what to Bill Brown.

Chief Financial Officer, who will provide an update on our financials.

Well.

Thank you that then and good morning, everyone for today's call I'll be providing an update regarding our second quarter financial results.

Our cash and short term investments balance was 80 million at June 30 S. Four an increase of 47 million since the first quarter.

Increase is attributable to 31.3 billion up warrant exercises and nearly 23 million from our at the market facility.

William Wood: The increase is attributable to 31.3 million Warrant Exercises and nearly 23 million from our at-the-market facility. Since quarter end, we have received an additional $9.6 million from the exercise of warrants and $2.5 million from ATM sales. Additionally, we closed a public offering for gross proceeds of $132.2 million.

Since quarter end, we've received an additional 9.6 million from the exercise of warrants and to that million from ATM sales.

Additionally, we closed a public offering for gross proceeds of 132.2 million.

With these additional cash receipts autoimmune has more than 200 million of cash and investments on hand, and is well positioned to advance this pipeline for at least the next two years.

William Wood: With these additional cash receipts, Altimmune has more than $200 million of cash and investments on hand and is well positioned to advance this pipeline for at least the next two years. As Scott Roberts discussed, a major use of the cash will be the scale-up of manufacturing for both ad-COVID and t-COVID to meet the demands of both those COVID-19 product candidates. Turning to the income statement, revenues for the second quarter were $720,000, which is a reduction of $900,000 compared to the second quarter of last year.

Hi, Scott Roberts discussed a major used to the cash will be on the scale up a manufacturing for both add coded anti cobot to meet the demands at both those coping 19 product candidates.

Turning to the income statement revenues for the second quarter were 720000, which is a reduction of 900000 compared to the second quarter last year.

Our revenue was lower year over year, considering an agent she'll clinical trial in preclinical work performed during 2019 compared to clinical trial startup activities only performed in 2020.

William Wood: Our revenue was lower year over year, considering the nasal shield clinical trial and preclinical work performed during 2019, compared to clinical trial start-up activities only performed in 2020. Research and development expenses were $23.8 million for 2020 compared to $6.2 million in the same period last year. The increase year-over-year of $13.6 million is primarily attributable to stock-based milestone payments associated with Alt-801. We carry a liability on our balance sheet for the fair market value of these non-cash payments, and during this quarter, we recognized $11.9 million of expense for an increase in the fair market value of the liability due to an increase in our stock price and an increase in the probability of success. Also impacting the change are increases in spend for the development of AD-COVID and T-COVID, in addition to a decrease in spend for Nasal Shield due to the cycle of product development.

Research and development expenses were 23.8 million for 2020 compared to 6.2 million in the same period last year.

The increase year over year, a 13.6 million.

Primarily attributable to stock based milestone payments associated with all eight a one.

We carry a liability on our balance sheet for their fair market value of these non cash payments and during this quarter, we recognized a $11.9 billion of expense for an increase in the fair market value of the liability due to an increase in our stock price increase in the probability of success.

Also impacting the change or increases in spend for the development of Atco that and Teco bid. In addition to a decrease in spend for Naser she'll do you get the cycle a product development.

Second quarter DNA expenses of 2.5 million, it's 300000 higher than the second quarter of 2019 due to an increase in compensation legal and professional costs.

William Wood: Second quarter G&A expenses of $2.5 million are $300,000 higher than the second quarter of 2019 due to an increase in compensation, legal, and professional costs. Our income tax benefit for the quarter was $1.6 million, which represents the second quarter portion of our 2020 net loss, which we expect to file a refund claim next year. Finally, the net loss attributed to common stockholders for the second quarter was $16.8 million compared to $3.4 million in the same period last year, with the net loss per share equaling $0.94 in the second quarter of 2020 versus $0.26 per share for the second quarter of 2019.

Our income tax benefit for the quarter was 1.6 million, which represents the second quarter portion of our 2020 net loss, which we expect to file a refund claim next year.

Finally, net loss attributable to common stockholders for the second quarter was 16.8 million compared to 3.4 million in the same period last year with net loss per share equaling 94 cents in the second quarter of 2020 versus 26 cents per share for the second quarter 2019.

[music].

With that I would like to now open the call for questions and answers operator.

William Wood: With that, I would now like to open the call for questions and answers. Operator? Thank you. At this time, we'll be conducting a question and answer session. If you'd like to ask a question, please press star 1 on your telephone. A confirmation tone will indicate your line is in the question zone. You may press star 2 if you'd like to remove your question from the line. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star 2.

Thank you at this time will be conducting a question and answer session. If he'd like to ask a question. Please press star one under telephone keypad a confirmation total indicate your line is in the question can you make for start to if you'd like to remove your question from Mccann for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star.

Our first question comes from line of Yasmeen Rahimi with Piper Salmon. Please proceed with your question.

Operator: Our first question comes from the line of Yasmeen Rahimi with Piper Chandler. Please, Hi team, congrats on the continued progress. Two questions for you. The first question is, can you shed light on what type of preclinical data we should be seeing between now and the initiation of the Phase I study? Maybe to the level of granularity that you can provide us.

Hi team, how congrats and the continued progress I'm two questions for you the first question.

Can you shed light on online what type of preclinical data, we should be seen between now and initiation not the case one study maybe two to the the level of granularity that you can provide us and then the second question is up for Veep and can you shed light on the man.

Yasmeen Rahimi: And then the second question is, for Vipin, can you shed light on the manufacturing, maybe what is left in order to kick off the Phase I study? Are you thinking about working with and adding on multiple manufacturers and continuing growing that? And thank you again for taking our questions. Yes, good morning, Yasmeen.

Refactoring, maybe what is left in order to kick off the phase one study or you're thinking about working and adding on multiple manufacturers and continuing going back and thank you again for taking my questions.

Yes, good morning gasoline. Thank you for the question I would let a Scott drop but sufficed to answer your first question and I'll take the second question Scott.

Vipin Garg: Thank you for the question. I would let Scott Roberts answer your first question first, and I'll take the second question. Scott.

Yes, good morning, as maintenance and thanks, Thanks for that question.

Scott Roberts: Yes, good morning, Yasmeen, and thanks for that question. So as far as the preclinical data between now and the clinical trial, as I mentioned during the call, the most immediate will be the T-cell data. This is the activation of T-cell responses that are able to kill infected cells and reduce the infection that way, and we expect to have those data here very shortly. We'll also be reporting at that time on additional neutralizing antibody data that we've obtained that we're looking forward to sharing. Beyond that, there'll be a continued evaluation of the specific types of antibody responses, what are the epitopes that are being targeted by both T-cells and B-cells, and we'll be looking at challenge models of COVID-19 in both rodents and non-human primates. So that's kind of the broad strokes of where we're going with that, and we look forward to sharing that data as it becomes available.

So as far as a preclinical data between now and the clinical trial as I mentioned a during the call for the most immediate will be the T cell data. This is an activation of T cell responses that are able to kill infected cells and reduce the infection that way, we expect to have those data here very shortly.

Well also be reporting at that time on additional neutralizing antibody data that we've obtained that Oh, we're looking for two to Sherry.

Beyond that Adobe continued evaluation of this specific types of antibody responses out what are what are the epitopes that are being targeted by both T cells and b cells and we'll be looking at a challenge models of Ur Cobot 19, a in both rodents and.

Non human primates, so that's kind of the broad brush strokes of where we're going with that we look forward to sharing that data as it becomes available.

And yes, yeah with regards to manufacturing as far as phase. One is concerned we have that allow weight debating Saxon lifting up still phase one as we announced a almost over a month ago now that we entered into a partnership it by Jean.

Vipin Garg: And Yasmeen, with regard to manufacturing, as far as Phase 1 is concerned, we are well on our way to manufacturing materials for Phase 1, as we announced almost over a month ago now that we entered into a partnership with Biogen Biosciences, and we've been working with them for a while, so they have, they're in the process of manufacturing the Phase I materials, and actually the Phase I and Phase II materials. But, in addition to our partnership with Vygene, we have entered into an agreement with another large manufacturer, an international manufacturer, and a third manufacturer. We have not announced the names of these two manufacturing partners, but we are well on our way to securing sufficient manufacturing capacity for Phase III and beyond into commercialization of ADCO. Thank you, team, and congrats again.

Bio Seinfeld, and they've been working with them for a while so they have that in the process of a manufacturing the phase one materials and actually phase one phase two materials, but.

In addition to our partnership with by Jean.

We have entered into an agreement that another large manufacture that factor that international manufacture that in a tough manufacture out we have not announced the mone stepping stone to manufacturing partner, but that rebel on I'll wait to securing sufficient manufacturing capacity for phase three and beyond a into commercialization.

Absolutely.

Thank you team.

Congrats again.

Thank you.

Operator: Thank you. Once again, ladies and gentlemen, if you'd like to join the question queue, please press star 1 on your telephone. Our next question comes from the line of Jonathan Wolleben, with James. Good morning and thanks for taking the questions. Just a couple on ADCOVID for me as well.

Thank you once again, ladies and gentlemen, if you'd like to join the question. Please press star one on your telephone keypad. Our next question comes from the line of Jonathan will then with JMP Securities. Please proceed with your question.

Hi, good morning, Thanks for taking the questions I'm just a couple on Alcobras for me as well.

This is the first I think we've heard about exploring a prime boost regimen and a I think you mentioned 120 subjects in phase one you talked a little bit more about your thoughts on the design as far as number of study arms I'm, a little will there be a control and how many different dose levels, we'd be looking out.

Jonathan Patrick Wolleben: This is the first we've heard about exploring a prime boost regimen. And I think you mentioned 120 subjects in phase one. Can you tell us a little bit more about your thoughts on the design as far as the number of study arms? Will there be a control? And how many different dose levels will you be looking at? Scott Harris.

Scott Harris.

Thanks, Jonathan.

Scott Harris: Thanks, Jonathan. Regarding the prime boost, as we noted previously, based on our preclinical data, and are experiencing some other clinical studies we don't think. [inaudible] So we're planning 120 subjects. Currently, the study would have four arms. Two doses, and for each dose, a single prime, and then a second prime boost.

Regarding the prime boost as we noted previously based on our preclinical data.

And our experienced some other clinical studies, we don't think that a prime boost we necessary, but we'd like to explore that to make absolutely certain that were not leaving.

Effectiveness on the table.

So we're finding 120 subjects.

Currently the study would have four arms.

Two doses and for each dose a single prime.

And then a second prime boost.

Oh, there will be a placebo control.

Scott Harris: There will be a placebo control that will be matched for the active ingredient as well. So, four active arms, if you would, and one placebo. We have not made a final determination of the doses, but they'll be in the range of the doses used in our prior studies with Nasovax and Nasoshield based on that experience and would reflect the doses that are being used in some of the other adenovirus vector studies. Great, and just one last one from me.

To be matched for the active ingredient as well so for active arms, if you would and one placebo.

Oh, we have not made a final determination of the doses, but they'll be in the range of the doses used in our prior studies with nasal Bucks and news or shield basin that experience and would reflect a the doses that are being used in some of the other I've known virus Specter studies.

Great and just one last one from me.

Mentioned, a little bit on your rationale for including just a receptor binding domain inner constructs.

Jonathan Patrick Wolleben: You mentioned a little bit about your rationale for including just the receptor binding domain in your construct. I know Pfizer decided to use a whole spike protein when they looked at their kind of array of options. Did you see something preclinically with your intranasal approach that favored the receptor-binding domain only, and are there options to maybe develop multiple constructs to move forward? Scott Roberts.

I know Pfizer decided to use a whole spike protein when they looked at their kind of array of options.

Did you see something Preclinically with your intermodal approach that.

Favored the receptor binding domain only and is there are options to maybe develop multiple constructs to move forward. Thanks.

Scott Roberts.

Yeah. So.

Scott Roberts: Yeah, so... Our selection of the RBD candidate was based on immunogenicity. All of these constructs were, you know, well-tolerated, and the animals looked fine as they always do during the, you know, during the studies. As you know, these products are extremely well-tolerated in the clinic, as Scott Harris mentioned. So our selection of RBD is really based on immunogenicity, where it was greatest with RBD. And you know, so with respect to Pfizer... It seemed as though they had selected the alternative vaccine based on safety considerations. And as you know, there is a rather strong immune response to the second immunization of the RNA vaccines. And so, evidently, they saw a better tolerability profile with the full length.

Our selection of the RPD can't it was based on Immunogenicity and all of these constructs where were you well tolerated that the animals look fine as they always do during the during the the studies.

As you know you know this these products are growing.

Extremely well tolerated in the clinic as Scott Harris mentioned, so our selection of R&D is really based on the Immunogenicity and where it was greatest with the RPD.

And and you know so with respect to Pfizer.

It seemed as though they had selected the the the alternative a vaccine based on a safety considerations and as you know there's.

Rather strong immune response on the second immunization of the of the R&D vaccines and so.

Evidently the they saw better tolerability profile, a with a with the with a full length. The narrowbody, we don't expect to see that sort of sort of effect. So our focus is on immunogenicity and with the safety deal is expected to be is excellent as there has been in the past.

Scott Roberts: On the RBD, we don't expect to see that sort of effect, so our focus is on immunogenicity, and with safety expected to be as excellent as it has been in the past. Terrific. Thanks again and congratulations on all the progress. Ladies and gentlemen, this concludes our question and answer session. I'll turn the floor back to Dr. Garg for any questions. Thank you, everyone, for listening in today. I will talk to you again on our next earnings call. Thank you. Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

Perfect. Thanks, again, and congrats on all the progress.

Thank you ladies and gentlemen. This concludes our question answer session I'll turn the floor back to Dr. Gardner for any final comments.

Thank you everyone thought listening in today, we look.

To your gain on our next earnings call. Thank you.

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