Q1 2020 Earnings Call

[music].

Thank you for standing by.

Operator: Thank you for standing by. This is the conference operator. Welcome to the Altimmune Incorporated First Quarter 2020 Earnings Conference Call. As a reminder, all participants are in listen-only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. To join the question queue, you may press * then one on your telephone keypad.

The conference operator.

Welcome to the LTM incorporated first quarter 2020 earnings conference call.

As a reminder, all participants are in but only mode and the conference is being recorded.

After the presentation, there will be an opportunity to ask a question.

He joined the question accumulate press Star then one or your telephone keypad.

If you need assistance during the conference call you may signal and operator by pressing star zero.

Operator: Should you need assistance during the conference call, you may signal an operator by pressing star and zero. I would now like to turn the conference over to Monique Kosas of Lifesci SciAdvisors. Please go ahead.

I'd now like to train the quite frankly overdone Monique costs, that's why I like <unk> sorry advisors. Please go ahead.

Monique Kosas: Thank you, operator, and thank you, everyone, for participating in today's first quarter 2020 earnings conference call. Leading the way today will be 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 first quarter 2020 financial results was issued last night and can be found on the investors page of the company's website.

Thank you operator, and thank you everyone for participating in todays first quarter 2020, <unk> earnings conference call.

Leading the way today will be.

<unk>, Chief Executive Officer, Oh, Oh.

Also participating on the call today is well Brown Chief Financial Officer, Scott Roberts, Chief Scientific Officer, It's got Harris, Chief Medical Officer.

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

A press release with the first quarter 2020 financial results was issued last night. It can be found on the investor 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 purpose of safe Harbor provisions under the private Securities Litigation Reform Act of 1995.

Monique Kosas: Before we begin, I would like to remind everyone that remarks about future expectations, plans, and prospects constitute forward-looking statements for the purpose 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 risk 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.

Oh, you mean cautions that these forward looking statements are subject to risks and uncertainties that could cause actual results could differ materially from those indicated including those related to cope with 19 and its impact on her business operations.

Clinical trials and results of operation.

For a discussion or some of those risk factors that could affect the company's future results. Please see the risk factors and other cautionary statements contained in that completes filings.

With the Securities and Exchange Commission.

I would also direct you to read the forward looking statements disclaimer in our earnings release issued last night and now available on our website.

These statements made on this conference call speak only as of today's date Thursday May 14, 2020 in 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.

Monique Kosas: Any statements made on this conference call speak only as of today's date, Thursday, May 14, 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. 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.

As a reminder, this conference call is being recorded and will be available for audio rebroadcast on ultra huge website at www altering dot com.

With that I will now turn the call over to fit them card Chief Executive Officer altering Stephens. Please go ahead.

Thank you money.

Good morning, everyone and thank you for joining us as we discuss our Q1 2020 financial results and corporate update.

Joining me on the call today's Bill Brown.

Chief Financial Officer, who will review, our Q1 financial results.

Scott Davis, our Chief Medical Officer.

Got Roberts, our Chief Scientific officer.

After all the discussion we will open the call for <unk>.

We have all watch in recent months the historic in fact of Corbett 19 on both our businesses and I'll personal lives.

I would talk San Francisco out all of those fighting this disease, including both pallet healthcare workers and those infected.

Vipin Garg: Thank you, Monique. Good morning, everyone, and thank you for joining us as we discuss our Q1 2020 financial results and corporate updates. Joining me on the call today is Bill Brown, our Chief Financial Officer, who will review our Q1 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 Q&A.

Most of all employees continue to work remotely.

Except in the cloud that personnel, who continue that important goal with 19 vaccine development work.

Despite operating under these conditions, we have made significant strides this year to advance our development programs.

Today, we would be providing you an update on our progress both on our vaccines and I'll do it just seems product candidates.

We advanced our corporate 19 vaccine candidate at Goldman.

In preclinical testing at the University of Alabama, Birmingham.

This is an important milestone for this program as we continue to be hopeful.

At our corporate 19 vaccine candidate and have a significant impact on the disease.

I believe the attributes of our platform technology and ideally suited for pandemic.

As a confirmation the world Health organization published a target product profile.

Put an ideal over 19 vaccine candidate.

Closely aligned.

Proven profile of our vaccine technology.

Namely <unk>.

Shifting to those non injectable vaccine.

Vipin Garg: We have all watched in recent months the historic impact of COVID-19 on both our businesses and our personal lives. Our thoughts and prayers go out to all of those fighting this disease, including both our health care workers and those infected. Most of our employees continue to work remotely, with the exception of our lab personnel, who continue their important COVID-19 vaccine development work. Despite operating under these conditions, we have made significant strides this year to advance our development program.

That can be shipped the doctors refrigeration.

Right and rapid and long lasting community.

Regarding nasal shield, our anthrax vaccine program.

We anticipate starting our phase one trial next month.

And the she'd like all of our vaccine candidate is designed as a single those intranasally vaccine and to secure.

And in $33.7 million contract.

With BARDA.

Most of which should be available.

BARDA exercises its option at the confusion the phase one trial.

These options take the program.

The phase two development.

Kevin Stein.

Maybe possibly could begin stockpiling the vaccine funded an emergency use authorization.

Continued to advance on April one.

GLP, one look on doing Magnus.

What the clinic without I envy, enabling studies and product manufacturing.

Im very excited about the potential of this program.

I have two had competitors enough outcome found.

And pre eminent mouse model.

More than doubled the weight loss compared to 70 died and greater improvement in histologic imagitas fatty liver.

Liver inflammation and fibrosis.

This is important that no one northeast recently announced their successful phase two trial.

Yeah, they met the primary endpoint.

Notion of Nash and no worsening of fibrosis.

However, we believe that all data one can do better and has the potential to achieve best in class profile not only for GLP, one did I therapeutics Nash drugs at home.

Finally, we have completed the manufacturing activities.

Vipin Garg: And today, we will be providing you an update on our progress, both on our vaccine and our liver disease product candidates. We advanced our COVID-19 vaccine candidate at COVID into preclinical testing at the University of Alabama at Birmingham. This is an important milestone for this program as we continue to be hopeful that our COVID-19 vaccine candidate will have a significant impact on the. I believe the attributes of our platform technology are ideally suited for a pandemic. And as a confirmation, the World Health Organization published a target product profile for an ideal COVID-19 vaccine candidate that closely aligns with the clinically proven profile of our vaccine technology, namely, a single-dose, non-injectable vaccine that can be shipped without refrigeration and provides rapid and long-lasting immunity.

And our finalizing the I indeed.

Which we expect to five next week.

A blind trial is a six month course of treatment and chronically infected hepatitis b patients.

Clinical sites in the U.S., Canada and Europe.

As disclosed in the press release, we wait to initiate this study onto the impact of called at 19 on the trials can be better understood.

I would not unlike the done default over to Scott Roberts, our Chief Scientific officer.

Well when fully update you on the progress we have made at gold it.

And Scott Hedis, who will discuss our clinical plans.

They do one.

Nasal shield Scott.

Thank you David <unk>.

Good morning.

As we previously shared with you we have created several vaccine candidates against a little bit 19, and there's no progress them to preclinical testing with our collaborators at the University of Alabama at Bermingham.

Where the vaccine candidates will be so really characterized for immunogenicity against Sars who'll be two bars.

One of the features that differentiates Ed good.

Mother, Cobot 19 vaccines and development is the broad immunity that can be induced following a single intranasally dose.

Based on preclinical and clinical data obtained with our other platform vaccines, we expect strong activation multiple arms of the immune system.

That does not only include neutralizing antibody, but also cellular immune.

And importantly, because humidity that can block the virus has decided one section.

You may be as a world class institution for studying the immunology of vaccines, especially vaccines directed against viral pathogens were excited about our collaboration on this project.

Well good work.

I understand at goes it will continue and become increasingly more sophisticated the core of experiments to be included in our I'd submission will be completed by the end of Q2.

And selection of the vaccine candidate to progress forward into clinical testing in Q4. This year will be made at that time.

Vipin Garg: Regarding NasoShield, our anthrax vaccine program, we anticipate starting our Phase 1B trial next month. Nasal Shield, like all of our vaccine candidates, is designed as a single-dose intranasal vaccine and is secured by a $133.7 million contract grant with BARDA, most of which should be available if BARDA exercises this option at the conclusion of the Phase 1b trial. These options take the program to the end of Phase 2 development.

In addition to the differentiated immunogenicity profile a bad committed.

Our other attributes of the platform may be equally important.

I didn't mention the WD choke published a target product profile that in many ways perfectly describes our vaccine platform technology.

As you May know a target product profile or TPP.

Identifies the minimally acceptable attributes of a drug products.

As well as the preferred attributes.

If one comparison number of the important preferred attributes that whr, we'd like to see anticoagulant 18 vaccine absolutely. It is expected to meet or exceed almost all the preferred characteristics, including single Ddos protection.

Rapid and durable immune response.

Voicing sub injections.

Vipin Garg: It may be possible to begin stockpiling the vaccine under an emergency use authorization. Continue to advance ALT801, our GLP-1 glucagon dual agonist, toward the clinic with our IND-enabling studies and product manufacturing. We're very excited about the potential of this program. In a head-to-head comparison of our compounds in the preeminent mouse model, we saw more than double the weight loss compared to semiglutide and greater improvement in histological measures of fatty liver, liver inflammation, and fibrosis. This is important as Novo Nordisk recently announced a successful Phase II trial where they met their primary endpoint of resolution of NASH and no worsening of fibrosis. However, we believe that Alt-801 can do better and has the potential to achieve a best-in-class profile, not only for GLP-1-derived therapeutics but NASH drugs as a whole.

And then enhanced product stability, including the ability to store the vaccine without refrigeration for months.

We believe that the product characteristics and Immunogenicity of had good will be significantly better than many of the vaccines being developed and will be an important contribution to the pandemic response.

With that I will turn the call over to Scott Harris, providing clinical update on our programs Scott.

Thank you Scott and good morning, everyone.

As Vipin mentioned, we're on track with R&D, enabling studies and manufacturing to commence dosing in our first in man clinical trial for all to either one or GLP one good gone dual arguments for Nash.

We're currently looking to commence this trial in Australia in the fourth quarter this year.

The initial draw will include six weeks of dosing and overweight and obese volunteers with fatty liver defined doesn't amreit pdfs greater than 10%.

We expect to ever read out on body weight loss and reduction in liver fat towards the end of the first quarter of 2021.

I will be a value driving event for investors as it will place else into one squarely in the forefront of Nash development.

At this point, we may elect to initiate a separate program in the treatment of obesity.

We expect all due to want to be well tolerated and achieve weight loss and improvement of liver fat in the phase one trial without the need to goes try trade for dry intolerability, which has impacted the GLP one development program space.

That's a conclusion of this first in human trial.

We plan to initiate a 12 week trial in patients with nosh, that's defined by noninvasive markers.

Vipin Garg: Finally, we have completed the manufacturing activities for Hep T cell and are finalizing the IND, which we expect to file next week. The planned trial is a six-month course of treatment for chronically infected hepatitis B patients, with clinical sites in the U.S., Canada, and Europe. As disclosed in the press release, we will wait to initiate this study until the impact of COVID-19 on the trial can be better understood. I would now like to turn the call over to Scott Roberts, our Chief Scientific Officer, who will fully update you on the progress we have made with ADCOVID and discuss our clinical plans for ALT801 and Nasal Shield. Scott.

We expect to data read out on the troll toward the middle of 2021 and rapidly transition to a full phase to be biopsy driven trial based on dosh endpoints at that time.

We hope that had a great deal of interest in the recently announced preliminary trial results from the 72 week tobacco TTI phase two trial, which demonstrated a remarkable improvement to notch, but only modest changes liver fibrosis.

We need to see the full read off from that for all but we suspect the tolerability as tobacco tide administered in high doses up to three to seven times higher than that prescribing dose resulted in sufficient and tolerability to limit drugs effectiveness, we feel confident that the improved efficacy in pharmacokinetic profile of.

Walter one compared to some back what Todd in our preclinical studies will translate to improved weight loss and Tolerability and that weekly dosing with Altera, one will demonstrate superior results in more convenience that tobacco tied when our trials are conducted.

[noise] wants to comment briefly on our Newser show vaccine for anthrax.

We anticipate or Nisa she'll program will start phase won't be trial in June and that we will have a data read out in November.

Scott Roberts: Thank you, Vipin, and good morning. As we previously shared with you, we have created several vaccine candidates against COVID-19 and have now progressed them to pre-clinical testing with our collaborators at the University of Alabama at Birmingham, where the vaccine candidates will be thoroughly characterized for immunogenicity against the SARS-CoV-2 virus. One of the features that differentiates ADCOVID from other COVID-19 vaccines in development is the broad immunity that can be induced following a single intranasal dose. Based on preclinical and clinical data obtained with our other platform vaccines, we expect strong activation of multiple arms of the immune system, that does not only include neutralizing antibody but also cellular immunity, and importantly mucosal immunity that can block the virus at the site of

Immunogenicity and safety.

If naser shield is shown to be safe and effective.

Back to to release, the remainder of the 133.7 billion dollar contract with BARDA and to move forward to a phase two trial and stockpiling and the strategic reserve.

And with that I'll turn back over to Vipin Garg <unk>.

<unk>.

Thank you Scott.

Hi, it's truly remarkable the progress we have made in recent months, especially considering the extraordinary circumstances in which we are working.

It is a testament to our dedication and commitment to our mission [laughter] shareholders.

With that I've done to follow up to them.

Our Chief Financial Officer.

Provide an update on our financials will.

Thank you get then and good morning, everyone.

For todays call I'll be providing an update regarding our first quarter 2020 financial results.

Our cash and short term investments ballots 33 million at March 31, 2020, representing a 4.3 billion dollar cash burn for the quarter.

Since quarter end, we have received net proceeds of approximately 600000 under our ATM.

Additionally, with the March 27th cares that provision that allows a carry back and net operating losses.

Plan to carry back our 2019 in 2018 tax losses to claim a 2.9 billion dollar cash refund.

Following this refund we will have the opportunity to carry back in 2020 losses during 2021 to claim an additional 1.8 million dollar refund.

Finally, it goes back to establish the Paycheck protection program and the company received a 632000 dollar forgivable loan, which will used to retain employees maintain payroll for rent and utilities all in accordance with the terms of the Cures Act.

Turning to the income statement revenues for Q1, or 2.2 million, which is a reduction of 740000 compared to Q1 2019.

Scott Roberts: UAB is a world-class institution for studying the immunology of vaccines, especially vaccines directed against viral pathogens, and we are excited about our collaboration on this project. While the work to understand COVID will continue and become increasingly more sophisticated, the core group of experiments to be included in our IND submission will be completed by the end of Q2, and selection of the vaccine candidate to progress forward into clinical testing in Q4 of this year will be made at that time. In addition to the differentiated immunogenicity profile of adcovid, our other attributes of the platform may be equally important. As Vipin mentioned, the WHO published a target product profile that, in many ways, perfectly describes our vaccine platform technology. As you may know, a target product profile, or TPP, identifies the minimally acceptable attributes of a drug product, as well as the preferred editor.

Our revenue was lower year over year, considering clinical trial in preclinical work performed in 2019 compared to clinical trial start up activities performed in 2020.

Research and development expenses were 7.2 million for 2020 compared to 3.2 million in the same period last year.

The increase year over year is attributable to development expenses incurred all eight to one as we perform I Indy, enabling preclinical studies and begin manufacturing.

As a reminder, this program was acquired in July 2019, and contain stock based milestone payments.

The carry a liability on our balance sheet for the fair market value of these non cash payments.

During the quarter, we recognized $1.75 million in expense for an increase in the fair market value of the liability due to an increase in our stock price and the increase in the probability of success.

Also contributing to the R&D increases are higher spend due to increased employee compensation costs and the development of at told that.

We saw a decrease in spin for needs the shield due to the cycle a product development.

Q1, 2020, DNA expenses of 2.3 million.

There's approximately $300000 higher than Q1 2019, due to an increase in compensation and legal costs offset by an increase in insurance premiums.

Our income tax benefit for the quarter was 3.2 million, which represents the 2.9 billion dollar refund discussed above in the Q1 portion of our 2020 net loss, which we expect to follow refund claim for next year.

Net loss attributable to common stockholders for the first quarter was 3.9 million compared to 2.6 million in the same period last year.

Scott Roberts: If one compares a number of the important preferred attributes that WHO would like to see in a COVID-19 vaccine, ADCOVID is expected to meet or exceed almost all of the preferred characteristics, including single dose protection, Rapid and Durable Immune Response, Avoidance of Injections, and enhanced product stability, including the ability to store the vaccine without refrigeration for months. We believe that the product characteristics and immunogenicity of adcovid will be significantly better than many of the vaccines being developed and will be an important contribution to the pandemic response. With that, I will turn this call over to Scott Harris, who will provide a clinical update on our program. Scott.

Net loss per share equaling 26 cents in Q1, 2020 persons 27 cents per share in Q1 2019.

Now I would like to open the call for questions and answers operator.

Thank you.

Well now begin the question and answer session to join the questions. You you May Press Star then one on your telephone keypad, you will share a tone acknowledging your request.

You are using a speakerphone please pick up your handset before pricing any keys to withdraw your question. Please press Star then too well, we'll pause for a moment as colors join the queue.

Our first question comes from Yasmeen Rahimi with Roth Capital Partners. Please go ahead.

Hi team. Thank you so much for taking your question.

You have a number for them for you to the first question a.

Team can you share with us what type of preclinical studies are currently underway for October.

Specifically have you begun our ready your challenge study and when should we be back saying.

The the results from the study and then I have a number follow up.

Bob Roberts.

Scott Harris: Thank you, Scott, and good morning, everyone. As Vipin mentioned, we are 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. We are currently looking to commence this trial in Australia in the fourth quarter of this year. The initial trial will include six weeks of dosing in overweight and obese volunteers with fatty liver, defined as an MRI-PDFF of greater than 10%. We expect to have a readout on body weight loss and reduction in liver fat toward the end of the first quarter of 2021. This will be a value-driving event for investors as it will place ALT 801 squarely at the forefront of NASH development.

Sure.

Morning, Yes, thank you for your questions.

Our preclinical studies have begun with the University of Alabama at Bermingham.

And that consistent with see immune profile that is that has been demonstrated with our upside for vaccines, we'll be looking at multiple arms of the immune system.

In those preclinical studies will be looking for antibody responses, which is what most people think about and certainly I will likely be an important part of the immune response.

Both totally antibody, Indiana body that is able to neutralize the virus. So that'll be important Oh, we'll also be looking at the induction. Though so you were immunity. This is the activation of T cells that can kill a infected cells and stopped the spread of infection in the hosts that way and so while those folks that are at the university of L.

Bam our expert at a that type of assets looking that specifically, where that's directed and in the how efficient that responses and then also and it really what's that separates us from a lot of the other all the other vaccines that are being developed for corporate banking.

Scott Harris: At this point, we may elect to initiate a separate program in the treatment of obesity. We expect ALT801 to be well tolerated and achieve weight loss and improvement of liver fat in the Phase 1 trial without the need to dose titrate for GI intolerability, which has impacted the GLP-1 development program space, at the conclusion of this first in human trial.

Is the mucosal immunity aspect and so what will be looking at the induction of this special type of communities that to block in section at the site Oh footwear, the bars trends to gain access to the to the hosted the dose in the respiratory tract and we'll be looking at a special type of antibody.

That's developed there called gay so.

Because we know our vaccines can induce all of these aspects of the immune system will be looking at all of those aspects in our preclinical studies.

Thank you Scott and then can you maybe share with us what are the rate limiting stuff or scaling up manufacturing at this point and then the last question. You can you tell US where you are in terms of your timeline on completing your.

Scott Harris: We plan to initiate a 12-week trial in patients with NASH, as defined by non-invasive markers. We expect a data readout on this trial toward the middle of 2021 and rapidly transition to a full phase 2B 5C-driven trial based on NASH endpoints at that time. We have had a great deal of interest in the recently announced preliminary trial results from the 72-week semaglutide phase 2 trial, which demonstrated remarkable improvements in NASH but only modest changes in liver fibrosis. We need to see the full readout from that trial, but we suspect the tolerability of semaglutide administered in high doses, up to three to seven times higher than the prescribing dose, resulted in sufficient intolerability to We feel confident that the improved efficacy and pharmacokinetic profile of Alt-801 compared to semaglutide in our preclinical studies will translate to improved weight loss and tolerability.

Tox package for a old either one.

Sure well, let's let's start at the end there with respect to the Tox package I want it benefits, we have given our out our.

Clinical experience with our vaccine platform and that that is very nature of the the vaccine platform is a we will not have to do or certainly are not anticipating doing a toxicology studies prior to a phase. One study. This is already a bit borne out in our previous studies in the FDA is comfortable.

So with see a the sector system and therefore, we won't have to repeat dose studies before entry into phase one. So that's that's a clear advantage will help.

As far as the manufacturing in a one of the things that we're doing is making sure that we de risk and give our ourselves the best possible chance to see a positive data quickly in our clinical studies so to that end Oh, we obtained a license for the Percy six cell lines from.

Johnson and Johnson actually that Jaeson subsidiary, and we'll be using that cell line out for our opinion factory now that's the same cell line that weve used for other products and we're able to broaden our.

Licensed a with Johnson so that we could include that four four atco bid and that this will certainly I hope because we're very used to using that cell line. It's an excellent cell line B.S.P.A. is very comfortable with that so and so by taking steps like that we've built and the success into our right into our vaccine.

Scott Harris: And that weekly dosing with Alt-801 will demonstrate superior results and more convenience than semaglutide when our trials are conducted. I wanted to comment briefly on our naso-shield vaccine for anthrax. We anticipate our NESA SHIELD program will start a Phase 1B trial in June and that we will have a data readout in November on both immunogenicity and safety. If NasoShield is shown to be safe and effective, we expect it to release the remainder of the $133.7 million contract with BARDA and to move forward to a Phase II trial and stockpile in the Strategic Reserve. And with that, I'll turn back over to Vipin Garg. (inaudible)

Thank you Scott I, just wanted to clarify sorry, I was referring to the Tox package for.

Oh, you know one for the next quarter I'm worried as in regards to timeline on finishing up.

Oh, that's fine sorry about that sure so that no program is going.

With that program is on track in and not in proceeding well, we expect to have.

The other tox package complete floor I M D and de <unk> in the fall and that will allow us to us to enter the a clinical trials that later at the end of the year. There. So a everything's on track with that we're seeing the sort of a sort of information we'd like to see fan the end, though a little or no problems.

So we're very oh very much on track with that and looking forward to getting that our Indian.

Oh, Thanks, a bunch of taking your question and the best of luck.

Vipin Garg: Thank you, Scott. It's truly remarkable the progress we have made in recent months, especially considering the extraordinary circumstances in which we are working. It is a testament to our dedication and commitment to our mission and to our show. With that, I will turn the call over to Bill Brown, our Chief Financial Officer, who will provide an update on our finances.

Thank you.

Our next question comes from Jim Molloy When Alliance Glover Global Partners. Please go ahead.

Hey, guys. Thanks for taking my questions and I guess my question <unk> or some of them around a lot of companies are seeing some some pretty good delays on the newer noncovered work.

Really just called itself going forward to talk a little bit too.

Your thoughts on on.

Well, what sort of a $10 for delays and you're on your trials for all day to want to have T cell or going forward and sort of or are they mitigated by how you've set up the trial the trial site design.

Yeah. The money good morning, Jim Thanks for the question, Matt as you can imagine.

Oh, you know we are actively monitoring the situation.

The good news is that many of pilot studies, our phase one type studies that a single center phase one unit studies.

William Wood: Thank you, Vipin, and good morning, everyone. On today's call, I'll be providing an update regarding our first quarter 2020 financial results. Our cash and short-term investments balance was $33 million at March 31, 2020, representing a $4.3 million cash burn for the quarter. Since quarter end, we have received net proceeds of approximately $600,000 under our ATM. Additionally, the March 27 CARES Act provision that allows a carryback of net operating losses.

But as far as hefty sound is concerned.

So that is that's it you know multinational multicenter study that's going to last six to nine months. So clearly that's where it's most critical for us to sort out the covert 19 situation and that's exactly what we're doing that I'll be monitoring the situation, we want to make sure and stop the study that able to.

I'm pleased that Oh. So therefore, we are delaying the start up that study even though we are finding deion de next week, so we should be ready to start and Goldman.

As early as a in June July timeframe.

But depending upon the covert 19 situation we will.

We would decide the exact stocking up that study.

With that let me, let me off that Scott had as to sort of fill in more details.

William Wood: We plan to carry back our 2019 and 2018 tax losses to claim a $2.9 million cash refund. Following this refund, we will have the opportunity to carry back our 2020 losses in 2021 to claim an additional $1.8 million refund. Finally, the CARES Act established the Paycheck Protection Program, and the company received a $632,000 forgivable loan, which it will use to retain employees, maintain payroll, and for rent and utilities, all in accordance with the terms of the CARES Act.

Oh, Thanks the thing.

I think you characterize it quite well.

Hi.

Don't know that we're going to be seeing any.

Tactical delays at this point, we're just monitoring the situation sensitive to the ability of sites to recruit patients enrolling the safety and the welfare patients and stuff. So.

So we're moving ahead with all the regulatory activities that will be necessary for conducting the trial full speed.

Then we actually pulled the trigger muddying patients come in will depend on alive analysis of the condition at each of the sites in each of the countries and we're looking at that very carefully right now.

And Scott said, they want and then on onto all April one and.

And I have to sell something and I need to shield.

Right and as you mentioned that then a there needs to shield study is a phase one study and we anticipate that starting.

In June.

And moving ahead in the new critically look good I didn't feel that June date will happen.

William Wood: Turning to the income statement, revenues for Q1 were $2.2 million, which is a reduction of $740,000 compared to Q1 2019. Our revenue was lower year over year considering clinical trial and preclinical work performed in 2019 compared to clinical trial startup activities performed in 2020. Research and development expenses were $7.2 million for 2020 compared to $3.2 million in the same period last year. The increase year over year is attributable to development expenses incurred with ALT801 as we perform IND-enabling preclinical studies and begin manufacturing. As a reminder, this program was acquired in July 2019 and contains stock-based milestone payments. We carry a liability on our balance sheet for the fair market value of these non-cash payments, and during the quarter, we recognized $1.75 million in 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 contributing to the R&D increases are higher spend due to increased employee compensation costs and the development of AddCOVID. Additionally, we saw a decrease in spin for Nasal Shield due to the cycle of product development.

At this point, we don't anticipate any delays for all it one it will be a phase one study and I think the same considerations that apply to the need to shield will also apply to the old it'll one program, but obviously, we're going to Oh.

Carefully monitored the situation or Australia in Ukraine, the contingency plans.

In case or other sites or their location. So loved the study are neither.

The following up on all data one is there any read through I know, it's a different mechanism of action, but any read through an engine said telford been or a phase three.

So you're basically are they just reported out that informs how are you guys would you look at all they don't ones trial design and the mistakes made that you guys will make and then on the obesity, what do you what sort of change in obesity the need to see to trigger that I will try and obesity trial and this out of the.

Phase one trial and I'll get a one.

Oh, so Jim.

As you know L three burn or as an entirely different mechanism it depends on a.

The mechanism called P.P.A.R. and they're different sub types of their yourself, a there's delta and there's gamma.

And probably the gamma is the most effective mechanism, but it has the most side effects and the still debate.

Whether delta.

I'd be affected the no will trigger was predominately adults though.

As you know they did a phase two study which failed to meet its primary endpoint.

The Rejiggered the a program based on a post talk analysis.

Those of US experience in drug development would not have moved into phase three.

So I think it's simply a failure of the drug in the mechanism and I think it has.

Oh reflects no way upon not only the efficacy of all tier one but other drugs other drug classes.

Could you refresh your second question I'm, sorry, I Didnt quite early take one right now.

Thank you for the thinks it if they don't do it. He just a question of what sort of magnitude weight loss would you need to see or want to see or what are the triggers you want to see either one phase one trial that will say artless, let's run on obesity trial I know, you're you've mentioned in his remarks, you wait to see the phase one data before we started in obesity trial in 21.

Right, well I feel coughing that we're going to be to other drugs and as you know the GLP ones. Your JV five 6%, but you have side effects.

William Wood: Q1 2020, GNA expenses of $2.3 million, is approximately $300,000 higher than Q1 2019 due to an increase in compensation and legal costs offset by an increase in insurance premium. Our income tax benefit for the quarter was $3.2 million, which represents the $2.9 million refund discussed above and the Q1 portion of our 2020 net loss, which we expect to file a refund claim for next year. The net loss attributed to common stockholders for the first quarter was $3.9 million compared to $2.6 million in the same period last year, with the net loss per share equaling $0.26 in Q1 2020 versus $0.27 per share in Q1 2019.

So I would start by saying just the beat those numbers you outside of trucks or would be a real positive in we showed in our animal data that we got two and a half times the weight loss and somebody who retired and we think are PK profile.

Is far superior to somebody go to tied so we feel very confident that we're going to get good levels of weight loss I would say that the first trial will only be six weeks. So only be a partial readout of the kind of weight loss. We can go to take 12 weeks or 24 weeks, but we will follow up.

Without six we draw with an immediate 12, we trial that'll be an unmatched population.

We will give us a better metrics you the amount of weight loss were going to obtain.

Okay last question on on the AD coded.

Trial will you be looking to get a non dilutive funding to run the and cool that knows quite a bit being on offer out there for the pin down again, and then can talk a little bit about any risks of of 80 eat a with the I'd koubei antibodies and <unk> you mentioned, the neutralizing antibodies and it rather than finding antibodies perhaps.

Operator: Now, I would like to open the call for questions and answers. Operator? Thank you. We will now begin the question and answer session. To join the question queue, you may press star and then one on your telephone keypad. You will hear a tone acknowledging your request. If you are using a speakerphone, please pick up your handset before pressing any keys.

Not an issue.

Let me let me take the first part of your questions Jim or so of course, we are in discussions with the number of potential non dilutive funding sources.

And you know those discussions are progressing well, but these things take time at the moment I'll focus is to.

Is to get that preclinical data and get ready for the phase. One studies, we think once we have to once we have the information that's going to sort of drive the program for what they were.

Plenty of sources of non dilutive funding. So we had engaged with all of them and we'll keep you posted it as we made good progress on that front.

Operator: To withdraw your question, please press star then 2. We will pause for a moment as other callers join the queue. Our first question comes from Yasmeen Rahimi with Roth Capital Partners. Please go ahead. Hi team. Thank you so much for taking our questions. We have a number for them for you. So the first question is, team, can you share with us what type of preclinical studies are currently underway at COVID? Specifically, have you begun your challenge studies yet, and when should we be expecting the results from those studies? And then I have a number of follow-up questions.

With regards to any thoughts Roberts do you want to take that question.

Sure I'm happy to and not Hello, Jim.

So the the issue with the 80, he or or more broadly immune enhance disease seems to really relate to and effective immune response say an immune response, that's there, but not quite strong enough and that's where the immune complexes can not units.

I'd like to pool in the lungs and creates some problems at least that's that's what's been seen in the past. So you know until we get into the clinic, obviously, you've got to do the work, but there's certainly no expectation that we'll see anything like that all of the data from our previous of vaccines Ah showed very strong immune responses.

Yasmeen Rahimi: Scott Roberts

Scott Roberts: Sure. Good morning, Yasmeen, and thank you for your questions.

Scott Roberts: Our preclinical studies have begun with the University of Alabama at Birmingham, and consistent with the immune profile that has been demonstrated with our platform vaccines, we'll be looking at multiple arms of the immune system in those preclinical studies. So we'll be looking for antibody responses, which is what most people think about and certainly will likely be an important part of the immune response, both total antibody and the antibody that is able to neutralize the virus. And so that'll be important. We'll also be looking at the induction of cellular immunity. This is the activation of T cells that can kill infected cells and stop the spread of infection in the host in that way. And so those folks at the University of Alabama are experts at that type of assay, and we'll be looking at specifically where that's directed and how efficient that response is.

To get to see antigens and in addition, a you know there's been a preclinical work looking at this with similar sort of approach or out of out of Oxford.

And that are showing that oh, where they specifically look for it and did not see it. So I think that there's a growing consensus that that may not be as much of an issue with a with a the surgical be too as it has been with some some few viruses in the past such as Dan good.

But you know that's something we'll have to keep an eye on and that's certainly do the studies to what you have to look at that carefully, but we're not anticipating a problem.

Thank you very much taking the questions.

Our next question comes from Lissa Saco with JMP Securities. Please go ahead.

Hi, guys about you look at Neal uncertainty. So I'm just a question on the read through for some agro tied it seems like the.

Scott Roberts: And also, and really what separates us from a lot of the other, all of the other, with the mucosal immunity aspect. And so we'll be looking at the induction of this special type of immunity that can block infection at the site where the virus tries to gain access to the host and the nose and the respiratory tract. And we'll be looking at the special type of antibody that's developed there called IgA. So because we know our vaccines can induce all of these aspects of the immune system, we'll be looking at all of those aspects in our preclinical studies.

The data was kind of a good scenario for you guys in the sense that.

Relative to GLP, one was pretty good results and that's resolution, but there's still kind of.

Room for improvement on the fibrosis front.

You think it was about are just not enough weight loss.

Or was it a matter of or the lack of a cool caught effect directly the liver or kind of a combination of both.

Scott status.

Hi, Thanks for the question.

The information I was provided in the conference call.

We completed and there really wasn't a lot of information provided in things searches weight loss.

I would agree with you that [noise].

Yasmeen Rahimi: Thank you, Scott. And then, can you maybe share with us what are the rate-limiting steps for scaling up manufacturing at this point? And then, lastly, can you tell us where you are in terms of your timeline for completing your tax package for ALT 801?

More than likely the in Tolerability of Cimaglia tied at the dose and they gave which just to remind you of three to seven times the prescribing does.

Because they literally gave up 2.4 milligrams per day, which is a daily dose.

Excuse me a weekly dose they gave the daily so up to seven times higher.

And we think that intolerability translated into a.

Discontinuations and dropouts and that affected the weight loss and I think that probably read through to the fibrosis, but we're gonna have to wait.

Scott Roberts: Well, let's start at the end there. With respect to the tox package, one of the benefits we have, given our clinical experience with our vaccine platform and the very nature of the vaccine platform, is that we will not have to do, or certainly are not anticipating doing, toxicology studies prior to a phase one study. This has already been borne out in our previous studies, and the FDA is comfortable with the vector system, and therefore, we won't have to repeat those studies before entry into phase one. So that's a clear advantage and will help.

The full data read out to.

Actually I see that.

We think that we could achieve.

Better levels of weight loss with better the levels of Tolerability, even without looking at the we'd be gone.

So in the liver.

Clearly the addition of the Goofy gone.

Coupled with the superior weight loss for granted we achieved could have really very remarkable effects.

On liver side and that we think would translate into Nash resolution as well as fibrosis and this is all seen in our animal models has a good thing mentioned.

So I think we're very bullish on our ability to achieve.

The changes across the spectrum of histology of Nash not only the reduction of liver fraud, and the resolution of not Nash inflammation.

Scott Roberts: As far as manufacturing is concerned, one of the things that we're doing is making sure that we de-risk and give our cells the best possible chance to see positive data quickly in our clinical study. And so to that end, we obtained a license for the Percy 6 cell line from Johnson & Johnson, actually, the Janssen subsidiary, and we'll be using that cell line for our manufacturing. Now, that's the same cell line that we've used for other products, and we're able to broaden our... License with Janssen so that we can include that for COVID. And this will certainly help because we're very used to using that cell line. It's an excellent cell line. The FDA is very comfortable with that cell line. So by taking steps like that, we've built in success into our vaccine.

But also a fibrosis, we think we can achieve that based on our mechanism.

Great. Thanks.

Welcome.

Once again, if you have a question. Please press Star then one.

This concludes the question answer session I would like to turn the conference back over to that then card for any closing remarks.

Thank you everyone listening in today, we look forward to speaking to you a gain on our next earnings call. Thank you.

This concludes today's conference call.

You may disconnect. Your line. Thank you for participating and have a pleasant day.

[music].

Yasmeen Rahimi: Thank you, Scott. I just wanted to clarify, sorry, I was referring to the tox package for ALT 801 for the NASH core ground where it is in regards to the timeline for finishing that.

Scott Roberts: Oh, that's fine. Sorry about that.

Yasmeen Rahimi: Sure. So that program is going. That program is on track and proceeding well. We expect to have the TOCS package complete for our IND in the fall, and that will allow us to enter clinical trials later at the end of the year there. So everything is on track with that. We're seeing the sort of information we'd like to see, and there are no problems.

Yasmeen Rahimi: Thank you so much for taking our questions and the best of luck. Thank you.

Jim Molloy: Our next question comes from Jim Molloy with Alliance Global Partners. Please go ahead.

[music].

Oh.

Vipin Garg: Hey guys, thanks for taking my questions. And I guess my questions are, some of them are around. A lot of companies are seeing some pretty significant delays on their non-COVID work and really just the COVID stuff going forward. Can you talk a little bit about your thoughts on what sort of potential areas for delays in your trials for Alt-Eta1 or Hep T cell going forward and, sort of, or are they mitigated by how you have set up the trial site design?

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[noise].

Vipin Garg: Yeah, good morning. Good morning, Jim. Thanks for the question. As you can imagine,

Vipin Garg: You know we are actively monitoring the situation. The good news is that many of our studies are phase one type studies that are single center, phase one unit studies.

Vipin Garg: But as far as hep T cell is concerned, that's a multinational multi-center study that's going to last six to nine months. So clearly, that's where it's most critical for us to sort out the COVID-19 situation, and that's exactly what we are doing. We're monitoring the situation.

Vipin Garg: We want to make sure that if we start the study, we are able to complete it. So therefore, we are delaying the start of that study even though we're filing the IND next week. So we should be ready to start enrollment as early as in the June or July time frame. But depending upon the COVID-19 situation, we will decide the exact start date of that study. With that, let me let me ask Scott Harris to sort of fill in more detail.

Scott Harris: Thanks, Vipin. I think you characterized it quite well. Don't know that we're going to be seeing any practical delays at this point; we're just monitoring the situation sensitive to the ability of sites to recruit patients and enroll them for the safety and the welfare of patients and staff. So we're moving ahead with all of the regulatory activities that will be necessary for conducting the trial full speed. When we actually pull the trigger on letting patients come in will depend on a live analysis of the condition at each of the sites in each of the countries, and we're looking at that very carefully right now.

Scott Harris: And Scott, you may want to respond to ALT801 and the hep T cell, sorry, and the nasal shield.

Scott Harris: Right, and as you mentioned, Vipin, the NASA SHIELD study is a phase one study, and we anticipate that starting in June and moving ahead, and we've critically looked at that and feel that that June date will happen. At this point, we don't anticipate any delays for ALT801. It will be a Phase I study, and I think the same considerations that apply to the NASA shield will also apply to the ALT801 program, but obviously, we're going to... Carefully monitor the situation in Australia, and we've created contingency plans in case other sites or other locations of the study are needed.

Jim Molloy: Then following up on Alt-Theta-1, is there any read-through on Genfitel-Fibonacar, a phase 3 failure basically, they just report it out. That informs how you guys will look at Alt-Theta-1's trial design, any mistakes made that you guys won't make. And then on obesity, what sort of change in obesity do you need to see to trigger that Alright, we'll try an obesity trial on this out of the phase 1 trial in Alt-Theta-1.

Scott Harris: So, Jim, as you know, L-Lifibrinol is an entirely different mechanism. It depends on a mechanism called PPAR, and there are different subtypes.

Scott Harris: So there's alpha, there's delta, and there's gamma. And probably gamma is the most effective mechanism, but it has the most side effects. And there's still debate about whether delta-blockers can be effective, and elefibrinol was predominantly a delta-blocker. As you know, they did a Phase II study, which failed to meet its primary endpoint. They rejiggered the program based on a post hoc analysis. Those of us who are experiencing drug development would not have moved into Phase 3. So I think it's simply a failure of the drug and the mechanism, and I think it has no reflection in any way upon not only the efficacy of Altaidol-1 but other drugs and other drug classes.

[music].

Scott Harris: And I, could you rephrase your second question? I'm sorry, I didn't quite retain that.

Jim Molloy: Borderetti. Thank you for the update on the other one. Just a question of what sort of magnitude of weight loss would you need to see or want to see, or what are the triggers that you want to see in the 801 phase one trial that will say, all right, let's run an obesity trial. I know you mentioned in your prepared remarks that you wait to see the phase one data before potentially starting an obesity trial at 21.

Scott Harris: Right. Well, I feel confident that we're going to beat other drugs. And as you know, the GLP-1s are achieving 5 to 6 percent weight loss, but you have side effects. So, I would start by saying, just to beat those numbers without side effects, [inaudible] So it will only be a partial readout of the kind of weight loss we can get at, say, 12 weeks or 24 weeks. But we will follow up with that six-week trial with an immediate 12-week trial that will be in a NASH population that I think will give us better metrics for the amount of weight loss we're going to obtain.

Vipin Garg: The last question on the ad-COVID trial: will you be looking to get non-dilutive funding to run the ad-COVID trial? I know there's quite a bit being offered out there for the pandemic. And then can you talk a little bit about any risks of ADE with the ad-COVID antibodies? I think you mentioned neutralizing antibodies rather than binding antibodies are perhaps not an issue

Vipin Garg: Let me take the first part of your question, Jim. So, of course, we are in discussions with a number of potential non-dilutive funding sources. And, you know, those discussions are progressing well. But these things take time. At the moment, our focus is to get that preclinical data and get ready for the phase one studies, we think. Once we have the information that's going to drive the program forward, there will be plenty of sources of non-dilutive funding, so we are engaged with all of them, and we'll keep you posted as we make progress on that front. With regard to ADE, Scott Roberts, do you want to take that question?

Oh no.

Hmm.

[music].

Scott Roberts: Sure, I'm happy to. And hello, Jim.

Scott Roberts: So the issue with ADE or more broadly immune-enhanced disease seems to really relate to an ineffective immune response, an immune response that's there but not quite strong enough, and that's where immune complexes can accumulate and form in the lungs and create some problems, at least that's what's been seen in the past. Until we get into the clinic, obviously, you've got to do the work, but there's certainly no expectation that we'll see anything like that. All of the data from our previous vaccines shows very strong immune responses against the antigens, and in addition, there's been preclinical work looking at this with a similar sort of approach out of Oxford, and they're showing that where they specifically look for it, and did not see it. And so I think that there's a growing consensus that that may not be as much of an issue with SARS-CoV-2 as it has been with some Thank you very much.

Mm Hmm.

[music].

Jim Molloy: Thank you very much for taking the question. Our next question comes from Liisa Bayko with J&P Securities. Please go ahead. Hi guys, Neil on behalf of Liisa.

Liisa Ann Bayko: Just a question on the read-through for semaglutide. It seems like the data was kind of a good scenario for you guys in the sense that it... validated GLP-1 with pretty good results in NASH resolution, but they're still kind of Room for Improvement on the Fibrosis Front. Do you think it was a matter of just not enough weight loss, or was it a matter of the lack of glucagon effect directly on the liver, or kind of a combination of both?

Scott Harris: Scott Harris

Scott Harris: Hi, thanks for the question. The information that was provided in the conference call was incomplete, and there really wasn't a lot of information provided on things such as weight loss. I would agree with you that, more than likely, the intolerability of semaglutide at the doses they gave, which, just to remind you, was three to seven times the prescribing dose, because they literally gave up to 0.4 milligrams per day, which is a daily dose, a weekly dose, but they gave it daily, so up to seven times higher. And we think that intolerability translated into discontinuations and dropouts But we're going to have to wait for the full data readout to actually see that.

Scott Harris: We think that we can achieve better levels of weight loss with better levels of tolerability, even without looking at the glucagon effects on the liver. But clearly, the addition of glucagon coupled with the superior weight loss we're going to achieve could have really, very remarkable effects on liver fat, and that we think would translate into NASH resolution as well as fibrosis. And this is all seen in our animal models, as Vipin mentioned. So I think we're very bullish on our ability to achieve. The changes across the spectrum of histology of NASH, not only the reduction of liver fat and the resolution of NASH inflammation but also fibrosis, we think we can achieve that based on our mechanisms.

[music].

Scott Harris: Great. Thanks, Scott. You're welcome.

Operator: Once again, if you have a question, please press star then one. This concludes the question and answer session. I would like to turn the conference back over to Vipin Garg for any closing remarks.

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

Operator: This concludes today's conference call. You may disconnect your line. Thank you for participating and have a pleasant day.

Operator: Health, Matthew Harris, Richard Eisenstadt, Seamus Fernandez, Liisa Bayko, Patrick Trucchio, ?Outro Music? Dr. William Wolleben, Richard Eisenstadt, Seamus Fernandez, Liisa Bayko, Patrick Trucchio, Jonathan Wolleben, William Wood, Yasmeen Rahimi, Matthew Harris, Scott Roberts, Mitchel Sayare, William Wood, Yasmeen Rahimi, Mayank Mamtani, Roger Song, Christian Figaroa, Altimmune Dr. William Wolleben, Richard Eisenstadt, Seamus Fernandez, Liisa Bayko, Patrick Trucchio, Jonathan Wolleben, William Wood, Yasmeen Rahimi, Mayank Mamtani, Roger Song, Christian Figaroa, ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? [inaudible] ?? ?Outro Music? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ??

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