Q1 2021 Altimmune Inc Earnings Call

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Greetings and welcome to the Ultimate Inc. First quarter 2021 earnings conference call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad as a reminder, this conference.

Operator: and welcome to the Altamune Inc. first quarter 2021 earnings conference call. At this time, all participants are in a listen-only mode.

Operator: 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. As a reminder, this conference is being required. I would now like to turn the conference over to your host, Ms. Stacey Jurchison, Senior Director, Investor Relations, and Corporate Communications Communications for all. Thank you. Thank you, Melissa, and good morning, everyone.

It's being recorded I would now like to turn the conference over to your host MS. Stacy Derchin Senior director Investor Relations and corporate communications for ultimately Thank you you may begin.

Thank you Melissa and good morning, everyone. Thank you for participating in <unk> first quarter 2021 earnings conference call, leading the call today will be vipin Garg, our chief Executive Officer additional members of the ultimate team participating on the call today are will Brown, our Chief Financial Officer, Scott Roberts, our Chief Scientific Officer.

Stacey Jurchison: Thank you for participating in Ultimian's first quarter 2021 earnings conference call. Leading the call today will be Vittengar, our chief executive officer. Additional members of the Altimian team participating on the call today are Will Brown, our chief financial officer; Scott Roberts, our chief scientific officer; and Scott Harris, our chief medical officer. Following the prepared remarks, we will hold a question and answer session. A press release with our first quarter of 2021 financial results was issued this morning and can be found in the Investor Relations section of the company's website.

And Scott Harris, our Chief Medical Officer.

Following the prepared remarks, we will hold a question and answer session. A press release with our first quarter 2021 financial results was issued this morning and can be found on the IR section of the Companys website.

Stacey Jurchison: Before we begin, I would like to remind everyone that remarks about future expectations, plans, and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Ultimmune 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 SEC.

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

Ultimately <unk> 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 Companys filings with the SEC I would also direct you to read the forward looking statement disclaimer in our earnings press release issued this morning, and now available on our website.

Stacey Jurchison: I would also direct you to read the forward-looking statement disclaimer in our earnings press release issued this morning and now available on our website. Any statements made on this conference call speak only as of today's date, Monday, May 17th, 2021, 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 replay on Altimian's website. With that, I will now turn the call over to Dr. Vippengarde, Chief Executive Officer of Altamian. Thank you, Stacey, and good morning, everyone.

Any statements made on this conference call speak only as of today's date Monday May 17th 2021, 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 replay on <unk> website with that I will now turn the call over to Dr. Vipin Garg, Chief Executive officer of Ultimate.

Yeah.

Thank you Stacey and good morning, everyone.

Vipin Garg: We appreciate you joining us today for the discussion of our first quarter 2021 financial results and business updates. We're trying a new format for our call this quarter and have a slight presentation accompanying our remarks. As Scott Roberts will review momentarily, we have impressive new preclinical data for our ad COVID vaccine candidate that we want to take you through. And the slides will be a helpful visual aid.

We appreciate you joining us today for the discussion of our first quarter 2021 financial results and business update.

We're trying a new format for our call this quarter and have a slide presentation accompanying remarks.

As Scot Roberts will review momentarily, we have impressive new preclinical data.

For our AD COVID-19 vaccine candidate that we want to take you through and the slides will be helpful Visual AIDS.

Our development efforts over the past year have set the stage for 2021 to be a data rich period for our company.

Vipin Garg: Our development efforts over the past year have set the stage for 2021 to be a data-rich period for us, and we now have multiple investigational candidates advancing in the clinic. For today's call, we want to focus on two of our most promising product candidates, Add COVID and Alt 801. We anticipate reporting top-line data from each of these programs next month, with data from the Phase 1 of COVID likely to read out first.

And we don't have multiple investigational candidates advancing in the clinic.

For today's call, we want to focus on two of our most promising product candidate at COVID-19 and Alt 801.

We anticipate reporting topline data from each of these programs next month.

With data from the phase one at COVID-19 program likely to readout for us.

As pioneers in intranasal vaccine development.

Vipin Garg: As pioneers in intranasal vaccine development, we are especially proud of our achievements as they relate to our at-COVID program. As an intranasal vaccine candidate, Ad COVID features unique attributes that are not available with currently authorized intramuscular vaccines, and therefore we strongly believe that if it is authorized or approved, it could become an important tool for the global COVID-19 vaccination effort, with the global pandemic continuing. There is widespread and growing awareness and interest in alternative vaccine approaches, and for good reason.

Especially proud of our achievements as they relate to our COVID-19 program.

As an intranasal vaccine candidate at COVID-19 features unique attributes that are not available with currently authorized intramuscular vaccines.

And therefore, we strongly believe.

That is authorized or approved.

COVID-19 could become an important tool for the global COVID-19 vaccination effort.

Yeah.

With the global pandemic continuing there.

There is widespread and growing awareness and interest in alternative vaccine approaches for good reason.

Although currently authorized vaccines have demonstrated excellent efficacy. They continue to be considered they continue to be there continues to be a considerable worldwide disparity in vaccine availability and increasing hesitancy around first generation of options.

Vipin Garg: Although currently authorized vaccines have demonstrated excellent efficacy, they continue to be considered, and there continues to be a considerable worldwide disparity in vaccine availability and increasing hesitancy around first-generation options. One of the key attributes I want to emphasize at COVID is the potential for excellent tolerability, which is critical for maintaining a high degree of vaccine uptake. Based on experience with our influenza vaccine candidate, Nasovax, we believe COVID will be extremely well tolerated and easier to administer, potentially even self-administered. In fact, clinical and preclinical studies without platform vaccine technology have shown a tolerability profile virtually indistinctable from placebo.

One of the key attributes I want to emphasize for at COVID-19.

Is the potential for excellent Tolerability, which is critical for maintaining a high degree of vaccine uptake.

Based on experience without influenza vaccine candidates nasal backs, we believe add COVID-19 will be extremely well tolerated and easier to administer.

Actually even self administered.

In fact clinical and preclinical studies without platform vaccine technology have shown a tolerability profile, we're truly in the strength Shapiro from placebo.

Vipin Garg: So we are very encouraged about this attribute of our vaccine candidates; as a single dose needle-free vaccine that is expected to be well-tolerated and thermostable, COVID believes it has the potential to address many of the current shortcomings of the COVID-19 vaccination effort and offer an important option for use in special populations such as pediatric and maternal immunization campaigns. As soon as authorization is granted, we anticipate ad COVID finding wide acceptance as a booster for revaxivination, including for coverage against variants of concern, and as a primary vaccine in the pediatric population and in developing countries based on its ease of intranasal administration and its expected stability profile.

We are very encouraged about the attitude about this attribute of our vaccine candidate.

As a single dose needle free vaccine.

That is expected to be well tolerated and total most stable we believe that COVID-19 has the potential.

To address many of the current shortcomings after COVID-19 vaccination effort and offer an important option for us.

Special populations, such as pediatric and maternal immunization campaigns.

Pending authorization, we anticipate AD called add COVID-19, finding by the acceptance as a booster for <unk> mission in.

Including for coverage against variants of concerns.

And the primary vaccine and is the primary vaccine in the pediatric population and in developing countries based on its ease of intranasal administration and its expected stability profile.

Accordingly, we are excited and cautiously optimistic about our upcoming phase one data readout.

Vipin Garg: Accordingly, we are excited and cautiously optimistic about our upcoming phase one data VDal, which we expect to announce in June. If the results of this trial are positive, we plan to quickly transition into a global phase two clinical development program, which Scott Harris will review in more detail momentarily. We are planning for success, and in parallel with the development of our Phase 2 program, we have taken steps to ensure our manufacturing readiness during the quarter.

Which we expect to announce in June.

If the results of this trial trial are positive.

We plan to quickly transition into a global phase III clinical development program.

Rich Scott Harris will review in more detail momentarily.

We are planning for success and in parallel with the development of our Phase II program, we have taken steps to ensure our manufacturing readiness.

During the quarter.

Vipin Garg: We announced the expansion of our agreement with Lonzer to include the construction of a dedicated manufacturing suite for AdCOVID, which will be capable of supplying product for late-stage clinical trials and potential future commercial supplies. Manufacturing constraints have been a significant hindrance in global COVID-19 vaccine production, and we want to help ensure our ability to supply AdCOVID on a commercial scale if it is authorized for use. We are operating in an exceptionally dynamic environment, as each new victory or setback in the COVID-19 vaccine space recasts the landscape. Consequently, we have to adapt to be adaptable and prepare to alter our course as events and developments dictate.

We announced do you expect for the expansion of our agreement with longer.

To include the construction of a dedicated manufacturing suite for that COVID-19.

Which will be capable of supplying product for late stage clinical trials and potential future commercial supply.

Manufacturing constraints have been a significant hindrance in global COVID-19 vaccine production efforts and we want to help ensure our ability to supply add COVID-19 on a commercial scale.

If authorized for use.

We are operating in an exceptionally dynamic environment at each new victory or setback in the COVID-19 vaccine space recast the landscape.

Consequently, we will have to a debt to be adaptable and prepare to alter our course as events and developments dictate.

Vipin Garg: In this context, we anticipated growing challenges in recruiting subjects to a placebo control study as the authorized vaccines become more widely available. Therefore, we amended our at-CO with Phase 1 clinical trial protocol to reduce the number of subjects in this study to approximately 80. I am pleased to report that we have now met the target enrollment in our amended phase one at COVID clinical trial and are on track to announce top line data in June.

In this context, we anticipate we anticipated growing challenges in recruiting subjects for a placebo controlled study.

As the authorized vaccines have become more widely available.

Therefore, we amended our AD COVID-19 phase one clinical trial protocol.

To reduce the number of subjects in this study to approximately 80 adults.

I am pleased to report that we have now met the target enrollment in our amended phase one at COVID-19 clinical trial and are on track to announce top line data in June.

Vipin Garg: It is important to note that the size of our amended study is comparable to the numbers of participants in phase one studies of the U.S. authorized vaccine and is more than sufficient to demonstrate the anticipated robust tolerability and immunogenicity of the vaccine. Should the data support moving forward, we anticipate commencing our proposed phase two development program quickly thereafter. Despite the availability of currently authorized vaccines, there is still a significant need and opportunity for a differentiated vaccine candidate like ADCOVID that may offer unique attributes. From a public health perspective, the potential to block transmission is important.

It is important to note that the size of our amended study is comparable to the numbers for participants in phase one studies of the U S authorized vaccine.

And is more than sufficient.

To demonstrate the anticipated robust total the tolerability and immunogenicity of the vaccine.

Should the data support moving forward, we anticipate commencing our proposed phase II development program quickly thereafter.

Despite the availability of currently authorized vaccines, there is still significant need and opportunity for a differentiated vaccine candidate like add COVID-19 that may offer unique attributes.

From a public health perspective, the potential to block transmission.

It is important.

Vipin Garg: And for the individual, the nasal route of administration and anticipated tolerability of COVID may also be very meaningful. Feedback from our key opinion leaders and the public suggest that the appeal of an intranasal vaccine remains strong. And we are optimistic about the future potential of our ad COVID vaccine candidate to make a difference in the global vaccination effort. Before Scott Harris provides an update on the clinical program, I would like to turn the presentation over to our chief scientific officer, Scott Roberts, to take you through some of the exciting new preclinical data that we have recently generated in collaboration with our partners at UAB. The SARS-CoV-2 challenge model that we will be discussing is Please go ahead.

And for the individual the nasal route of administration and anticipate the Tolerability of Agco, but may also be very meaningful.

Feedback from our key opinion leaders and the public suggests that the appeal of an intranasal vaccine remains strong.

And we are optimistic about the future potential of our AD COVID-19 vaccine candidate to make a difference in the global vaccination effort.

Before Scott Harris provides an update on the clinical program.

I would like to turn the presentation over to our Chief Scientific Officer, Scott Roberts.

To take you through some of the exciting new preclinical data that we have recently generated in collaboration with our partners at UAB.

The Sars COVID-19 two challenge models that we will be discussing.

He's considered one of the best animal models for COVID-19 research and.

And we are particularly encouraged by the new data in this robust model Scott.

Scott Roberts: Thank you, Vipin, and good morning, everyone. While our Ad-Covit vaccine candidate is progressing through our first inhuman trial, we continue to conduct three clinical studies with our collaborators at the University of Alabama, Birmingham. St. We will be reporting on additional data from other preclinical studies shortly, including a study evaluating the ability of COVID to provide cross-protection against emerging variants of concern. But today, I would like to share with you the results of two important preclinical studies that provide exciting insights into the activity of ADCOVID.

Please go ahead.

Thank you vipin and good morning, everyone.

While our AD COVID-19 vaccine candidate is progressing through our first in human trial we.

We continue to conduct preclinical studies with our collaborators at the University of Alabama, Birmingham for St. Louis University.

We will be reporting on additional data from other preclinical studies shortly including a study evaluating the ability of bad for a bid to provide cross protection against the emerging variance of concern.

But today.

I'd like to share with you the results of two important preclinical studies that provide exciting insights into the activity of Ed COVID-19.

The preclinical study results we are presenting today build on the results of efficacy Challenge studies.

Scott Roberts: The preclinical study results we are presenting today, build on the results of efficacy challenge, We have previously shared with you, showing that a single intranasal dose of ad COVID completely protected mice from clinical signs of infection and resulted in a greater than 1,000-fold reduction and SARS-cove-2 virus in the lungs of vaccinated mine, if you refer to slide five, you will see that these results are graphically presented. One of the points I'd like to emphasize about the human ACE2 transgenic mouse model we have used is that it is a very stringent model, for controlling viral replication with very high levels of infection and viral replication in the In our new analysis, We evaluated the effect of ad COVID vaccination, on the amount of infectious virus in the lungs of mice infected with SARS-coved The left and middle portions of the slide show the profound reductions in viral RNA, that resulted from vaccination with adverse.

We have previously shared with you.

<unk> that a single intranasal dose of Ed COVID-19 completely protected mice from clinical signs of infection.

And resulted in a greater than 1000 fold reduction in.

And Sars Cov two virus in the lungs are vaccinated mice.

If you refer to slide five.

You will see that these results are graphically presented.

One other points I'd like to emphasize about the human Ace III transgenic mouse model, we have used.

It is that it is a very stringent model.

For controlling viral replication with very high levels of infection and viral replication in the lungs.

And our new analysis, we evaluated the effect of bad COVID-19 vaccination on the amount of infectious virus in the lungs of mice infected with Sars COVID-19 two.

The left in the middle portion of the slide show the profound reductions in viral RNA.

That resulted from vaccination without COVID-19.

Scott Roberts: As you can see on the right-hand portion of the graph, vaccination with ADCOVID resulted in an inability to recover infectious virus from the lungs of challenged animals three days after post-infection, whereas nearly 300,000 platforming units, that is greater than log 5 of virus, were recovered from the lungs of the unvaccinated control. It is important to emphasize here that these results were obtained following a single intranasal dose We are excited about the ability of Ed COVID to provide sterilizing immunity and protect the vaccinated in the face of such high levels of viral replication, as it may have direct relevance for ADCOV to provide protection from COVID-19 and, more importantly, block transmission.

As you can see on the right hand portion of the graph vaccination with that COVID-19 resulted in an inability to recover infectious virus from the lungs of challenged animals three days post infection.

Whereas nearly 300000 platforming units.

That is greater than logged five of virus were recovered from the lungs of the unvaccinated control mice.

It is important to emphasize here that these results were obtained from a single intranasal dose of Ed COVID-19.

We are excited about the ability of it to over to provide sterilizing immunity in vaccinated mice in the face of such high levels of viral replication as it may have direct relevance for COVID-19.

To provide protection from COVID-19, and more importantly bark transmission.

We have also evaluated how vaccination with that AD COVID-19 affects the development of inflammatory lung disease associated with the infection of Sars Cov two virus on.

Scott Roberts: We have also evaluated how vaccination with that COVID affects the development of inflammatory lung associated with the infection of the SARS-CoV-2 virus. On slide six, you will find low and high magnification pictures of lung sections obtained from human ACE2 transgenic mice four days post-challeng with SARS-CoV-2. What is important to note here is that the mass of lung inflammation observed in the unvaccinated mice after infection with SARS-CoV-2, shown on the left-hand side of the slide, was essentially prevented following vaccination with a single intranasal dose of ad COVID, shown on the right-hand side.

On slide six you will find low and high magnification pictures of lung long sections obtained from human Ace two transgenic mice for days post challenge with Sars Cov two.

What is important to note here is that the massive lung inflammation observed in the unvaccinated mice after infection with Sars Cov two shown on the left hand side of the slide was.

It was essentially prevented following vaccination with a single intranasal dose of Ed COVID-19 shown on the right hand side of the slide.

Scott Roberts: These data are, of course, consistent with the ability of ADCOVID to dramatically reduce viral replication and completely neutralize infectious virus in the lungs of infected mice and provide further evidence of the potent protective effects of ADCOVID vaccination. As I mentioned earlier, we will be reporting on the ability of ADCOVID to induce cross-reacting antibodies that are able to neutralize emerging variants of concern. Recall that another way COVID is differentiated from nearly all other COVID-19 vaccines, either authorized or in development, is that we are targeting the immune response specifically to the receptor binding domain, or RBD, of the viral spike protein.

These data are of course, consistent with the ability of October to dramatically reduce viral replication and completely neutralized infectious virus, new lungs of infected mice and provides further evidence of the potent protective effects of COVID-19 vaccination.

As I mentioned earlier, we will be reporting on the ability of bad COVID-19 to induce cross reacting antibodies that are able to neutralize the emerging areas of concern.

Recall that another way and COVID-19 is differentiated from nearly all other COVID-19 vaccines either authorized or in development.

That we are targeting the immune response, specifically to the receptor binding domain or <unk> of the viral spike protein.

We believe that by doing this we can focus the immune response and the most relevant portion of the spike protein.

Scott Roberts: We believe that by doing this, we can focus the immune response on the most relevant portion of the spike process, which may result in a differentiated neutralizing antibody response that includes antibodies that are not present in response to the entire spike protein targeted by other vaccines.

Which may result in a differentiated neutralizing antibody response that includes antibodies that are not present in response to the entire spike protein targeted by other vaccines.

We look forward to share the results of those important studies with you shortly.

Scott Harris: We look forward to sharing the results of those important studies with you shortly. On a related note, we are advancing the preclinical evaluation of several variants of COVID vaccines, including Ed COVIDP1, as we prepare for a clinical study of that vaccine later this. I will now turn the presentation over to Scott Harris to discuss our clinical efforts. Thank you, Scott.

A related note.

We are advancing the preclinical evaluation of several variant COVID-19 vaccines, including Ed COVID-19 P. One.

As we prepare for clinical study of that vaccine later this year.

I will now turn the presentation over to Scott Harris to discuss our clinical efforts.

Scott.

Thank you Scott.

Scott Harris: We're encouraged by the progress we have made in our phase one ad-COVID clinical trial and our comprehensive plans for a global phase two development program. Let me begin with a brief review of our phase one clinical design and the outcomes we anticipate reporting in June. Please refer to slide eight of the earnings call, debt.

We're encouraged by the progress we have made in our phase one COVID-19.

Clinical trial, and our comprehensive plans for our global Phase III development program.

Let me begin with a brief review of our phase one clinical design and layout.

<unk>, we anticipate reporting in June.

We used to refer to slide eight of the earnings call deck.

The ZIP and noted we amended our current.

Scott Harris: As Vipin noted, we amended our ad-COVID phase one protocol due to the challenges of recruiting in placebo-controlled studies in the U.S. as a result of the widespread availability of authorized vaccines. We have adjusted our enrollment in this study to approximately 80 subjects, randomized five to one to receive one or two doses of COVID or placebo administered in three-dose groups. Immigienicity readouts will include neutralizing antibodies, anti-spike IGG, and anti-spike IGA as an indicator of mucosal immunogenicity measured 28 days apart after the first and second doses.

Current phase one protocol due to the challenges of recruitment and placebo controlled studies in the U S. As a result of the widespread availability of authorized vaccines.

We have adjusted our enrollment in the study to approximately 80 subjects randomized five to one to receive one or two doses of <unk> or placebo administered three dose groups.

Immunogenicity Readouts will include neutralizing antibodies anti spike agg and anti Spike RGA as an indicator of mucosal Immunogenicity measured 28 days apart after the first and second doses.

Scott Harris: Topline results on antibody responses are expected in June, with T-cell readouts expected to follow approximately four to six weeks thereafter. As Vipin noted, the size of the trial is similar to the phase one studies of the authorized COVID-19 vaccines and more than sufficient to demonstrate a clear vaccine effect and establish the tolerability profile of ADCOVID. Moving on, we have developed a robust slate of phase two clinical trials to support our anticipated COVID target product profile, which is shown in slide 9.

Topline results on antibody responses are expected in June with T cell readouts expected to follow approximately four to six weeks thereafter.

As Vipin noted the size of the trial was similar to the phase one studies of the authorized COVID-19, vaccines and more than sufficient to demonstrate a clear vaccine effect and establish the tolerability profile of COVID-19.

Moving on we have developed a robust slate for phase III clinical trials to support our anticipated add COVID-19 target product profile, which is shown in slide nine.

Scott Harris: As you can see from this slide, the planned phase two studies are meant to directly support the key elements of our differentiated target product profile or TPP. For example, to evaluate whether ADCOVID will boost the natural immune responses to wild type and variant vaccines, and variant viruses, we plan to conduct a study of naive and previously infected but unvaccinated individuals in low-access countries. To confirm our belief that ADCOVID will boost the immune response to wild type and variant viruses in previously vaccinated individuals, we plan to conduct a re-vaccination study with parental and variant vaccines in a country with good vaccine access, such as the U.S.

As you can see from this slide the planned phase two studies are meant to directly support the key elements of our differentiated target product profile or TPP too.

To evaluate whether add COVID-19 will boost the natural immune responses, so wild type and Barry impacts seen very and viruses. We plan to conduct a study of naive and previously infected, but unvaccinated individuals and low access countries.

To confirm our belief that COVID-19 will boost the immune response to wild type and very very environ.

And previously vaccinated individuals.

We plan to conduct a re vaccination study.

With parental and vary in vaccines in the country with good vaccine access such as the U S.

Scott Harris: This study will also confirm the ability of ADCOVID to provide mucosal immunity to individuals previously vaccinated with a parental COVID-19 vaccine. To confirm that ADCOVID will be well tolerated and immunogenic in children down to two years of age, we plan to conduct an age-based de-escalation study in young children and adolescents. And finally, we believe the safety of ADCOVID in pregnant and breastfeeding women can be established by conducting a maternal immunization study to demonstrate that ADCOVID is safer for use in pregnant and breastfeeding women.

This study will also confirm the ability of Ed Provost to provide mucosal immunity. The individuals' previously vaccinated with a parental COVID-19 vaccine.

To confirm that add COVID-19 will be well tolerated and immunogenic and children down to two years of age.

We plan to conduct an age based Deescalation study in young children and adolescence.

And finally, we believe the safety about COVID-19 and pregnant and breastfeeding women can be established by conducting a maternal immuno immunization study to demonstrate that a COVID-19 assay for use in pregnant and breastfeeding women.

Switching gears now and moving to slide 11.

Scott Harris: Switching gears now and moving to slide 11, and our ALT-801 program, we anticipate top-line data from our phase wound clinical trial next month. The ALT 801 Phase 1 clinical trial is evaluating single ascending doses and six and 12 week multiple ascending doses of ALT 801 and overweight and obese subjects. At this time, we've completed enrollment in the single ascending dose phase of the trial and three planned cohorts in the multiple ascending dose phase of the trial.

And our LT it'll one program, we anticipate top line data of our phase one clinical trial next month.

The <unk> phase one clinical trial for.

Is evaluating single <unk> doses in six and 12 week multiple ascending doses of <unk> hundred one in overweight and obese subjects. At this time, we have completed enrollment in the single sending dose and three planned cohorts in the multiple ascending dose phase of the trial.

Yeah.

Looking ahead, we anticipate reporting 12 week data in the third quarter of 2021.

Scott Harris: Looking ahead, we anticipate reporting 12-week data in the third quarter of 2021. If the data from this trial are positive, we plan to transition to a 52-week phase two biopsy-based trial in Nash patients in early 2022. We also anticipate finally initiating an I&D in the second half of the year to initiate a separate Nash study in the United States. But there may be more to the ALT801 study. As noted now on slide 12, Novenorges and Lully have executed successful Phase 3 programs that have de-risked the obesity space previously occupied by safe and ineffective drugs. However, GI intolerability has been the Achilles heel of GOP-1-based treatments, with side effects leading to treatment discontinuation.

If the data from this trial are positive we plan to transition to a 52 week phase two biopsy based trial in Nash patients in early 2022.

We also anticipate filing an IND in the second half of the year.

To initiate a separate Nash study in the United States.

But there may be more to the LT it'll warm study.

As noted now on slide 12.

Moving to or just didn't really have executed successful phase III programs that have derisked, the obesity space previously occupied by sales and ineffective drugs.

However, reorient Tolerability has been the achilles' heel of <unk> based treatments with side effects, leading to treatment continuation.

William Wood: If the impressive weight loss and safety of ALT 801 and preclinical studies are translated to the clinical setting, ALT 801 could become a best-in-class treatment for this multi-billion dollar indication. The filing of an I&D application for obesity is being evaluated, with the final decision based on the upcoming phase one data readout. I will now turn it over to Will to give an update on our first quarter financial results. Thank you, Scott, and good morning, everyone.

If the impressive weight loss and safety of <unk> in preclinical studies are translated to the clinical setting LT EDA, one could become a best in class treatment for this multibillion dollar indication.

The filing of an <unk> in obesity is being evaluated with the final decision based on the upcoming phase one data readout.

I will now turn it over to will to give an update to our first quarter financial results will.

Thank you Scott and good morning, everyone for today's call I will be providing a brief update on our first quarter 2021 financial results more comprehensive information can be found in our 10-Q filed with the SEC today.

William Wood: For today's call, I will be providing a brief update on our first quarter 2021 financial results. More comprehensive information can be found in our 10-Q filed with the SEC today. Altamund ended the first quarter with a robust balance sheet, including cash and short-term investments totaling approximately $227 million as compared to $216 million at the end of 2020.

Ultimately ended the first quarter with a robust balance sheet, including cash and short term investments totaling approximately $227 million as compared to $216 million at the end of 2020.

William Wood: The increase in our net cash during the current period is attributable to 34.2 million of net receipts during the quarter, primarily due to our utilization of the at the market or ATM offering program, partially offset by approximately 20 million of cash used for operating at. With these additional cash receipts, we remain solidly capitalized to advance our pipeline candidates through potentially value-generating inflection points in 2021 and beyond. Turning to the income statement, revenue in the first quarter of 2019 was 800,000 compared to 2.2 million in the first quarter of 2020.

The increase in our net cash during the current period is attributable to $34 2 million of net receipts during the quarter.

Primarily due to our utilization.

The at the market for ATM offering program, partially offset by approximately $20 million of cash used for operating activities.

With these additional cash receipts, we remain solidly capitalized to advance our pipeline candidates, who are potentially value generating inflection points in 2021 and beyond.

Turning to the income statement revenue in the first quarter of 'twenty, one was 800000 compared to $2 2 million in the first quarter of 2020.

William Wood: The change in revenue between the periods was primarily due to a decrease of $2 million in barter revenue due to the timing of clinical trials and development activities for NASA, which is partially offset by 500,000 in revenue attributable to the TCOVID program. R&D expenses were approximately $12 million in the first quarter compared to 7.2 million in the first quarter of 2020, which represents an increase of 4.7 million. The change is primarily the result of an increase of 5.4 million related to development activities for our COVID program, partially offset by a decrease of 1.5 million in charges related to the contingent consideration liability associated with the acquisition of Alt-801.

The change in revenue between the periods was primarily due to a decrease of 2 million from BARDA revenue due.

Due to the timing of clinical trials and development activities for Natus yield, which was partially offset by 500000 in revenue attributable to the G. COVID-19 program.

R&D expenses were approximately $12 million in the first quarter compared to $7 2 million in the first quarter of 2020, which represents an increase of $4 7 million.

The change was primarily the result of an increase of $5 4 million related to development activities for our COVID-19 programs, partially offset by a decrease of $1.5 million in charges related to the contingent consideration liability.

In connection with the acquisition of either one.

G&A expenses were $3 8 million in the first quarter of 'twenty, one compared to $2 3 million in the prior period, primarily due to increased stock comp expense and additional labor and related costs.

William Wood: GNA expenses were 3.8 million in the first quarter of 2021 compared to 2.3 million in the prior period, primarily due to increased stockcom experience and additional labor-related costs. Net loss for the three months ended March 31, 2021, was 14.9 million or 38 cents net loss per share compared to 3.9 million or 26 cents net loss per share for the first quarter of 2020.

Net loss for the three months ended March 31, 2021 was $14 9 million or 38.

Net loss per share compared to $3 9 million or 26 net loss per share for the first quarter of 2020 debt.

Vipin Garg: The difference in net loss is primarily attributable to higher research and development and general administration. I will now turn it back over to Vippin for his closing remarks. Thank you, Will, Scott Roberts, and Scott Harris for joining me today and sharing your perspective. And thank you, those of you on the call today and listening to the replay, for your continued support and interest in our program. We have several promising and important shots at gold this year.

Difference in net losses, primarily attributable to higher research and development and general and administrative expenses.

I will now turn it back over to Vicki <unk> for his closing remarks.

Thank you Bill and Scott Roberts, and Scott Harris for joining me today and sharing your perspective.

And thank you, though those a few on the call today and are listening to the replay for your continued support and interest in our programs.

We have several promising an important shots on goal this year.

Operator: As you have heard, we are eagerly awaiting the data results from both the ADCOVID and ALT-O-1 programs. We believe there is tremendous opportunity to create value for our stockholders if either or both programs advance. I'm confident in the clinical development strategy we have laid out to further the development of our ad COVID and Alt 801 candidates, and look forward to sharing the initial top-line data and our continuous progress with you.

Uh huh.

Yes, even the awaiting the data readouts from both theatrical day and Alt 801 programs we.

We believe there is tremendous opportunity to create value for our stockholders, if either or both programs advance.

I'm confident in the clinical development strategy, we have laid out to further the development of Apollo that COVID-19 and Alt 801 candidates.

I look forward for sharing the initial topline data.

And our continued progress with you.

Operator that concludes my formal remarks could you. Please instruct the audience on the question and answer procedure.

Operator: Operator, that concludes my formal remarks. Could you please instruct the audience on the question and answer procedure? Thank you. If you would like to ask a question, please press Star 1 on your telephone. The confirmation tone will indicate your line is in the question Q. You may press Star 2 if you'd like to remove your question from the list of questions for participants using speakerphone. It may be necessary to pick up your handset before pressing Star.

Thank you.

If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.

You May press star two if you'd like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys.

Seamus Christopher Fernandez: Our first question comes from the line of Seamus Fernand, with Guggenheim. Please proceed with, "Oh, great." Thanks for the question. I just wanted to ask a few here, first on the ADCOVID program. Has the agency approached your team with any questions with regard to the possibility of, you know, coagulation, safety issues, and being able to disprove that preclinically? I know this is very challenging and perhaps not possible, but just wanted to get a better sense of that from your perspective. And then, in terms of the change from 180 patients and reducing that number down to 80. Can you just give us the reasons for that?

Our first question comes from the line of Seamus Fernandez with Guggenheim Partners. Please proceed with your question.

Oh, great. Thanks for the question. So just wanted to ask a few here first on the COVID-19.

For the program.

Healthy agency approach.

Your team with any questions with regard to.

The possibility of.

Coagulation safety issues and being able to disprove that.

Pre clinically.

This is very challenging and.

Perhaps not possible, but just wanted to get a better sense of.

That from your perspective, and then in terms of the change.

From 180 patients.

Reducing that number down to 80.

Give us the reasons for that.

Seamus Christopher Fernandez: Is it just confidence in the data that you see coming up in the phase one clinical data set? And then that will be, you know, obviously expanded and borne out in the full phase three. And was that agreed upon with FDA in terms of just the size of the required clinical study? And then, if I, if I may, just two additional questions.

Is it just confidence in the data.

But you see upcoming.

In the in the phase one clinical data set and then that will be obviously expanded in born out in the emblem for phase III.

Was that agreed upon with.

With FDA in terms of just the size of the required clinical study.

And then if I if I may just.

Two additional questions.

Seamus Christopher Fernandez: As we think about the data that you are anticipating to be able to move forward with conviction in the phase two clinical studies, what's the threshold for neutralizing antibodies, IGD neutralizing antibodies, that you believe is necessary to move forward with a single dose of ADCOVID? Thank you. Yeah, good morning, Seamus.

As we think about the the.

The data that you are anticipating.

To be able to move forward with conviction in the phase two clinical studies.

What's the threshold for neutralizing IGD neutralizing antibodies that you believe is necessary to move forward with a single dose.

Of Ad COVID-19.

Yeah.

Yes, good morning Seamus.

Vipin Garg: Maybe what we can do is divide and conquer. So, Scott Roberts, do you want to take the first part of the question and then turn it over to Scott Harris and perhaps come back for the third part of the question? Sure, happy to, and good morning.

Maybe what we can do this.

Divide and conquer since Scott Roberts do you want to take the first part up for question and then turn it over to Scott Harris and perhaps come back for the for the third part of the question.

For sure happy to and not good morning Seamus.

Scott Roberts: Thanks for the questions. So with respect to the FDA and the, you know, TTS, no, there has been no communication about that. The FDA is clearly aware of our, you know, GOP toxicology studies where we were able to demonstrate that there was no systemic dissemination of the vector following intranasal delivery. And while there are more questions and answers about the mechanism of this effect, one thing that does seem to be more likely than not, I would say, is that systemic exposure of the vector and vector components may have a catalytic effect.

Thanks for the questions so with respect to the FDA in the end the yet.

A T T S.

There has been no communication about that.

The F D a.

Is clearly aware of our G.

GOP toxicology studies, where we were able to demonstrate that there was no systemic dissemination.

Actor falling intranasal delivery and.

While there is more questions than answers about the mechanism of this effect.

One thing that does seem to be more likely than not I would say is that that the systemic exposure of the vector and vector components may have.

The catalytic effect zone on the on the pay up for so in the absence of that I think we're in good stead as you said trying to prove a negative there would be very difficult, especially given the rarity of this but no no formal communication or informal from from the FDA on that point.

Scott Roberts: on the PF4. So in the absence of that, I think we're in good stead. As you said, trying to prove a negative there would be very difficult, especially given the rarity of this, but no formal communication or informal from the FDA on that point. Scott, do you want to go ahead and handle the clinical question? Right, and then I'll turn it back over to you, Scott, for the final question. So, shameless, we have a lot of confidence in the size of the study. The readouts are clearly comparable to the size of the phase one studies of the authorized U.S. vaccines.

From Scott do you want to go ahead and handle the clinical question.

Right and then I'll turn it back over to you Scott for the final question. So shameless, we'd have a lot of confidence in the size of the study.

Readouts or clearly.

Terrible for the <unk>.

As for the Phase one studies.

We authorized U S vaccines, so I think that gives us additional confidence and also this when the readouts over prior studies.

Scott Harris: I think that gives us additional confidence and is also based on the readouts of our prior studies. And, you know, we've had no specific indication that this would be unacceptable to the agency, especially in view of what I've just mentioned. Scott, do you want to answer the third question?

And we've had no.

Specific indication that this would be unacceptable for the agency, especially in view of what I've just mentioned Scott do you want to answer the third question.

Sure.

Scott Roberts: Sure, and that question related to, you know, our expectations for neutralizing antibody in order to continue the program forward, especially as a single-dose vaccine. And, you know, to begin with, the ultraming, we'll still refrain from numerical expectations because of the variability in the assays and the way that they're done. And so as far as a tighter, I don't think that it's productive to go down that road.

Related to our expectations for for neutralizing antibody in order to continue that program.

Program forward.

Especially as the single dose vaccine.

And to begin with Ultra mountain.

Still refrain from numerical.

Our expectations because of the variability and the assets and the way that they're done and so as far as our tighter I don't think that it's productive to go down that road I think most people are comfortable with the relationship to convalescent Sera and of course. This year at very made me would be characterized and understood. The components that made up that convalescent Sera.

Scott Roberts: I think most people are comfortable with the relationship to convalescence, and of course, the serra variant may be characterized and understood by the components that made up that convalescence there. So we certainly expect to be in the range of convolescence syrup. I think one of the things that we've learned from the studies that have been conducted so far is that really surprisingly low levels of neutralizing antibody are associated with protection, and that we've learned that primarily from the inactivated vaccines, which really have, you know, what I would consider to be astonishingly low neutralizing antibody titers.

We certainly expect to be in the range of of convalescent Sera I think one other things that we've learned from other studies that have been conducted so far is that.

Really surprisingly low levels of neutralizing antibody or associated with protection and that we've learned there primarily from the inactivated vaccines, which really have you know what I would consider astonishing growth neutralizing antibody titers and so when we when we think about that and when we think about the other immunogenicity that we are bringing to the table can be closer.

Scott Roberts: And so when we think about that and when we think about the other immunogenicities that we are bringing to the table, the mucosal immunity especially and the strong T-cell responses, we feel that a neutralizing antibody response on par with convalescent serra would be a home run for us. Great, thanks, guys.

Linearity, especially in the end the strong T cell responses.

We feel that their neutralizing antibody response on par with convalescent Sera is a it's a home run for us.

Great. Thanks, guys I appreciate it.

Thank you. Our next question comes from the line of Yasmin Rahimi with Piper Sandler. Please proceed with your question.

Operator: Thank you. Our next question comes from the line of Yasmin Wahimi with Piper Sandler. My team, thank you for the great updates. I also have a number of questions. I'll just go, ask them one by one.

Hi team. Thank you for that Great update I also have a number of questions, but I'll just call it.

Ask them one by one maybe the first question for you is can you comment on whether we would be seeing in June data on.

Yasmeen Rahimi: Maybe the first question for you is, can you comment on whether we would be seeing data in June on both the single and the dual shot given, or just for one. And if you could just help us, I know, fine tune a little bit more granularly when we should be expecting this data as early June, mid-June, and June to the extent you can comment on. And then the third question that I think is really important on the minds of many of our clients that we speak with is what are the forward steps beyond that.

So the single and dual shot or.

Given them or just for one.

And if you could just help us I know I'm fine tune a little bit more granularly when in June we should be expecting debt data at that early June mid June.

The extent you can comment on.

And then the third question.

It's really important on top of minds of many of our clients that we speak with is.

What other steps.

Beyond that.

Can you maybe highlight what would be the size.

Yasmeen Rahimi: Can you maybe highlight what the size of phase three would be, and the timelines around that? That would be really great. Absolutely. Scott Harris, do you want to take the first question? Right, yes, yes me. Thank you for your questions.

Of the phase two phase three the timelines around that that would be really helpful.

Absolutely Scott Harris do you want to take the first question.

Right, Yes, I mean, thank you.

For your questions, Yes, we will have.

Scott Harris: Yes, we will have data on both the single and the double doses in the June timeframe. And right now, we are confident that we will be announcing in June. We haven't provided, you know, specifics, and exactly when that will occur in June. The future programs, as you can see, there is a robust list of studies that will support the phase two program and build the target product profile. Obviously, these studies are different sizes because they have different objectives, so that in all, the Phase II program will be large.

Data on both the single and the double doses.

In the June time frame and right now.

We are.

Confident that we will be.

Announcing in June we haven't provided.

The specifics of exactly when that will occur in June.

Regarding the future.

Future programs.

As you can see there are there is a robust list of studies that will support the phase.

Two program and build the target product profile. Obviously these studies are different sizes, because they have different objectives.

So that in all the phase III program will be large.

There are many different phase II studies to prepare to compare against but we have a multitude of phase III studies. So it's an approximation I would say that the phase III program is large and will be executed between the readout in June and then towards the end of the year.

Scott Harris: There are many different phase two studies to compare, to compare against, but we have a multitude of phase two studies. So, as an approximation, I would say that the phase two program is large and will be executed between the readout in June and the end of the year. Thank you for the color.

Sure.

Thank you for the color, maybe if I could just have a follow up on that same question.

Scott Harris: Maybe if I could just follow up on that same question. We understand there are quite a number of debates depending on the geography, whether a placebo would be needed in future phase two, phase three, and whether orthogonal vaccine approaches. If you could just comment on those types of discussions where maybe regulators stand on, that could be helpful, and then I have one more.

We understand there are quite a number if they depending on the geography, whether a placebo would be needed in future Ace <unk> three.

And whether I talk at all vaccine approaches if you could just comment on those types of discussions where maybe regulator stand on that that could be helpful. And then I have one question.

Scott Harris: Right. Well, as you know, because of the availability of authorized vaccines in the U.S., it's been increasingly difficult for any sponsor to do a placebo-controlled trial. That paradigm will change as we move to variant vaccines and re-vaccination, where there would be some latitude to do that. Clearly, as one goes around the world, there are many opportunities to study the vaccine in unvaccinated populations where a placebo control would be very acceptable. And that has been the basis of the strategy of moving some of the phase two programs, at least one of the studies, to a low-access country. Thank God.

Alright, well as you know because for the availability of authorized for vaccines from the U S. It's been increasingly difficult for any sponsor.

A placebo controlled trial.

That paradigm will change as we move to.

The Varian vaccines and re vaccination, where there would be some latitude to do that clear.

Clearly as one goes around the world. There's there are many opportunities.

This study the vaccine in unvaccinated populations, where a placebo control would be very acceptable and that has been the basis of the strategy of moving some of the phase II programs at least one of the studies to a low excess country.

Thank you.

Yeah go ahead sorry.

Scott Harris: Yeah, go ahead. I would say that the regulators have not been very specific about the question of placebo control. Clearly, the FDA is quite interested in placebo-controlled studies more so than comparator-controlled studies. They're more robust, but the specific requirements have not been announced by the agency.

I would say that the regulators have not been very specific about the question of placebo control clearly the FDA is quite interested in a placebo controlled studies more so than comparator controlled studies that are more robust, but the specific requirements have not been announced by the agency.

Scott Harris: Thank you, Scott. Maybe this is another question for you in relation to the announcement to file an I&D for the obesity indication. Just if you could highlight the thoughts behind that and then why this is a focus, you know, for the second half.

Thank you Scott maybe that's another question for you in relation to the announcement to file an IND for the obesity indication.

Just if you could highlight what the thoughts behind that and then why this is that's okay.

Yeah.

For the second half and maybe how gift for and if the regulatory path for obesity births have been asked that could be very helpful.

Scott Harris: And maybe how different is the regulatory path for obesity versus the Nash? That could be very helpful for us. Right. Thanks for the question, Yasmin. Well, as you know, when we announced our program in 2019, the regulatory space and national obesity were quite different. And as you can see, since this time, there's been somewhat more uncertainty about the acceptability of surrogate endpoints in Nash but much more confidence in programs like the Nova Nordisk and the Lilly programs to move ahead.

Right.

Thanks for the question you asked me was you know when we announced our program in 2019, the regulatory space in Nash and obesity, we are quite different and then as you can see since this time, it's been somewhat more uncertainty about the acceptability of surrogate endpoints for Nash.

But much more confidence in programs like the Novo Nordisk and the lowly programs to move ahead as you know, we previously had ineffective and unsafe drugs in this space.

Scott Harris: As you know, we previously had ineffective and unsafe drugs in this space, and now we have the prospect of two approvals in the near future, both on GLP1-based compounds in obesity with robust efficacy but really very concerning tolerability with lots of discontinuations. You know, we believe that we can beat that.

Of the prospect of two approvals in the near future both on <unk> based compounds.

And obesity with robust.

<unk> efficacy.

But really very concerning tolerability with lots of discontinuation.

We believe that we can beat that we think that's a low hurdle and we think based on our phase in our preclinical studies that we can achieve excellent if not better.

Scott Harris: We think that's a low hurdle, and based on our preclinical studies, we think, based on our preclinical studies, that we can achieve excellent, if not better, weight loss with better tolerability and the prospect of even not needing dose titration. And obviously, we'll speak to that with our study results. So, national obesity and national smoking are both billion-dollar indications, and it behooves us to take on both because we not only have a drug for national obesity. And remember that more than 80%, if not, more than 90% of patients with national obesity are overweight. Consequently, if you're treating obesity and you do get an indication of obesity, you're naturally capturing most of the entire Nash space, and not just the

Weight loss with better Tolerability and the prospect of even not meeting dose titration and obviously, we will speak to that with our study results. So Nash and obesity are both billion dollar indications and it behooves us to take on both because we normally would have the drug for national.

<unk> and remember.

More than 80%, if not more than 90% of patients with Nash or obese. So consequently, if you're treating obesity and you do get an indication obesity naturally capturing most of the entire Nash space and not just for people who have Nash, but also NAV.

We'll do so it is an opportunity that we are strongly considering it.

Scott Harris: So it's an opportunity that we're strongly considering. It's much going to be based on our readouts and the amount of weight loss that we see in our phase one study, and consequently, the decision to file that I&D and develop a program will be doubt driven.

It's much going to be based on our read outs in the inbound of weight loss that we see in our phase one study and consequently, the decision to file that all day and developer program will be data driven.

Yeah, and I would just add yes that debt.

Scott Harris: Yeah, and I would just add, yes, that we're not de-emphasizing Nash. We just think that there's a parallel opportunity here in obesity that became very clear to us as we go and talk to KOLs, and we talk to potential strategic partners. Everybody wants to know, what about obesity? It looks like you have a drug for obesity as well, so that's clear, and our preclinical data clearly shows that. And if we see similar weight loss in our human treatment, then by all means, it makes sense to proceed with obesity in parallel with NAS.

We're not deemphasizing Nash, we just think that there's a parallel opportunity here in obesity that became very clear to us as we go and talk to Kols, we talk to potential strategic partners everybody wants to know what about obesity. It looks like you have a drug for obesity as well so it became clear and Oh.

Our preclinical data clearly shows that then if we see similar weight loss in our human trials.

By all means it makes sense to proceed with obesity obesity in parallel with Nash.

Scott Harris: Thank you, team, for taking your questions. Thank you. Our next question comes from the line of Kouachi Chickley with Jeff. Yes, good morning, and congratulations on all the progress you've made over the quarter. Just a few questions from me here.

Thank you team for taking a question.

Thank you. Our next question comes from the line of collecting check range with Jefferies. Please proceed with your question.

Yes. Good morning, Congrats from all the progress you've made over the quarter just a few questions from me me here.

Kouachi Chickley: You mentioned you would like to see neutralized nanobody titers on par with convalescent serum. I'm hoping you can provide a little bit more details around that compilic serum. Is that Sarah compared mostly for mildly infected individuals, hospitalized patients? Any color there would be greatly appreciated.

You'd mentioned you would like to see neutralizing antibody titers on par with convalescent serum I'm, hoping you can provide a little bit more details around that convalescent serum at debt.

For compare there mostly from mildly affecting individuals' hospitalized patients any color there would be greatly appreciated and I guess also just related to another question that was asked earlier I'm, hoping you can provide a little bit more details around your latest thoughts on the data set that you think you'll need to generate to support a regulatory filing is it just the immunogenicity.

Kouachi Chickley: And I guess also just related to another question I was asked earlier, I'm hoping you can provide a little bit more detail, details around your latest thoughts on the data set that you think you'll need to generate to support a regulatory filing. Is it just immunogenicity data? Is it efficacy data? Any color of it would be helpful.

Data is it efficacy data.

Any color there would be helpful and I guess just.

Kouachi Chickley: I guess just it. And is that something you think you can generate on your own or do you anticipate meeting that part? Scott Roberts. Thank you, Chequiry. Kallachi, sorry.

And is that something you think you can generate on your own or do you anticipate needing a partner for that thank you.

Scott Roberts.

Thank you check range.

Got you sorry, Scott Roberts do you want to take for the question.

Scott Roberts: Scott Roberts, do you want to take the first question? Sure. All I can say at this point is we'll be providing the composition and, you know, composition of the convalescent cera as we release the data so that those data can be interpreted at that time. Coletia, this is Scott.

Sure.

All I can say at this point is we'll be providing the.

A description and the composition of the convalescent Sera as we released the data so that those data can be interpreted at that time.

Yeah.

Okay.

Okay.

Scott Harris: Thank you for the second question. As you know, the landscape is rapidly changing. I think there's scientific consensus for a correlative protection being neutralizing anybody's, but the regulators have to accept that. If the regulators do accept a correlative protection, we could get authorization or approval based on an immunogenicity readout, and that may come with a later obligation to do an outcomes-type trial. But if the approval or authorization is based only on correlative protection, that is, immunogenicity, the obligation to do trials, the size of the trials is much smaller. It's probably a safety database of approximately 3,000 subjects. And as you know, it's much larger for outcomes trials. So, clearly, we could do a trial of that magnitude.

Collectively this is Scott. Thank you for the second question.

The landscape is rapidly changing I think there is scientific.

Consensus of a correlative protection being neutralizing antibodies.

But the regulators have to accept that.

If the regulators do except to correlate it protection, we can get authorization for approval based on Immunogenicity readout and that May come with a later obligation of doing an outcomes type trial, but if if if.

If the approval or authorization is based only on the carload of protection that is immunogenicity the obligation to do trials. The size of the trials is much smaller it's probably a safety database with approximately 3000 subjects.

As you know it's much larger for outcomes trial. So clearly we could do a trial of that magnitude a much larger trial is something we would anticipate doing with a partner because of the expense of the <unk>.

Vipin Garg: A much larger trial is something we would anticipate doing with a partner because of the expense of the trial and the landscape is rapidly changing, and we need to remain flexible, and we are, Yeah, and Kalecce. I would just add that with regard to, you know, future development and funding, we continue to talk to multiple sources. We think our phase one data, the quality of that data, is going to be critical in advancing those discussions. So both we are in discussions with potential corporate partners, as well as with government sources of funding to develop our vaccine. And we'll continue to do that.

Trial, and the landscape is rapidly changing and we need to remain flexible and we are.

Yeah, and collecting I would just add debt with regards to you know future.

<unk> funding, we continue to talk to multiple sources, we think our phase one data.

Quality of that data is going to be critical in advancing those discussions. So both we are in discussions with potential corporate partners as well as with the government sources of funding.

True to develop all vaccine them, we'll continue to do that that's really going to be data driven mainly the stage one data that we're expecting here soon.

Vipin Garg: It's really going to be data-driven, mainly on this phase one data that we are expecting here soon. Thank you. Thank you. Our next question comes from the line of John Wendt, JMP Securities, please. Hey, good morning, and thanks for taking the question.

Thank you.

Thank you. Our next question comes from the line of John Weldon with JMP Securities. Please proceed with your question.

Hey, good morning, and thanks for taking the question just a follow up on Alt 801 in obesity indication, but I was hoping you could give us a little more context on what you would want to see to differentiate with just moving forward in Nash versus adding on the obesity.

John Wendt: Just a follow-up on Alt 801 in the obesity indication. I was hoping you could give us a little more context on what you'd want to see to differentiate between just moving forward in Nash versus adding on the obesity indication. What kind of magnitude of change do you want to see, I guess, in body weight and then also with the GI tolerability profile? What would make it interesting to compel you to move forward with obesity? Scott has always said that.

Indication what kind of magnitude of change do you want to see I guess in body weight and then also.

With the Gi Tolerability profile, which would make it interesting to.

Capella had them before and obesity.

Scott.

Scott Harris: Yeah, Jonathan, thank you for the question. So what I'd rather do is relate or bring in outside opinions, and this has been stated, and I refer to Juan Pablo Frias, who is an expert in the space, and he's publicly stated that anything greater than 2% at six weeks would be a success. Could you please refresh me on the second part of your question? My question is, when you're making decisions before about obesity, how, what magnitude of difference do you need to see between just moving forward in Nash or adding on obesity.

Yeah, Jonathan and thank you for the question so what I'd, rather do is relate or bring in outside opinions and as have been stated.

Refer to Juan Pablo free us.

Who.

He is an expert in this space.

And he has publicly stated that anything greater than 2%.

At six weeks he thinks would be a success.

Could you. Please refresh me on the second part of your question.

So.

My question is when you're making the decision to move forward in obesity.

Magnitude of difference do you need to see in between.

Between just moving for Nash or adding on obesity, just trying to kind of understand what do we see the standard or you're going to but at.

Scott Harris: Just trying to kind of understand when we see this data, are you going to at the same time say this is worthwhile in the case of obesity, or is that going to be a decision later? Well, it's really the same decision because if we get that kind of weight loss that we're anticipating, we're going to have a successful Nash drug. Because weight loss is the most effective mechanism for treating Nash, and we think that all of the beneficial effects of weight loss are going to be transmitted to Nash.

At the same time say this this is worthwhile and obesity or is it going to be a decision later on.

Well, it's really the same decision because if we get that kind of weight loss that we're anticipating we're going to have a successful from a stroke because weight losses for most potent mechanism for treating Nash and we think that all of the beneficial effects of weight loss or going to convey to Nash. So we believe.

Scott Harris: So we believe that the decision point would be the both one, would be the same one, say, both programs. That's helpful. Thank you. Thank you. Our next question comes from Lisa Baker with Evercore ISI. Hi, good morning.

The decision point would be to Vodafone would be the same let's say both programs.

That's helpful. Thank you.

Thank you. Our next question comes from the line of Lisa <unk> with Evercore ISI. Please proceed with your question.

Hi, good morning, and thanks for taking my question.

Lisa Baker: I'm just looking at slide five, we're discussing sterilizing immunity in mice. And so what is the definition of sterilizing immunity? And what's the difference between, you know, how do you think about the replicating viral RNA versus the infectious virus, and maybe you can discuss a little bit of the differences between those and what actually is sterile. Scott Roberts.

Slide five we're discussing them.

Yeah, that's sterilizing, the median life and so yeah.

What is the accident the definition of sterilizing immunity and what's the difference between you know how do you think about the replicating the viral RNA person.

Texas virus, and maybe you can talk a little bit in between.

Between those and what accident years sterilizing.

Okay.

Scott Roberts.

Sure happy happy to answer them.

Scott Roberts: Sure, happy to answer, and nothing. So let's start with sterilizing. I think a consensus definition of that would be no infectious virus, the inability of the virus to replicate in the host, and that also means it cannot spread. And that's what we demonstrate in the lungs, that no infectious virus could be found. Now, when we looked at the RNA, know, the total RNA, which includes both the input dose, the dose that was given to challenge the animals with Sarascope 2, and any replication that occurs.

So let's start with with sterilizing.

I think.

Consensus.

The definition of that would be no no infectious virus the inability of the virus to replicate in the hosted and that means also tip to spread.

And that's what we demonstrated in the lungs debt no infectious virus could be found now when we looked at the RNA.

Total RNA, which includes both the the input dose that the dose that was given to challenge the animals with the Sars cov, two and any replication that occurs that RNA is.

Scott Roberts: That RNA is certainly representative of the virus being present, but it's not equal to an infectious virus. And the reasons for that are numbers. The neutralization may happen a little bit later, but more importantly, not all of that RNA is necessarily encapsulated in a virus particle that represents an infectious unit. You've got lice cells that release the RNA.

Certainly representative of the virus being present.

But it's not it's not equal to infectious virus and the reasons for that are our numbers for all day.

The Mutualization may happen, a little bit later, but more importantly.

Not all of that RNA is necessarily encapsulated in a virus particle that represents an infectious unit.

Got that life's cells that are released the RNA. So there's a there's a lot of arent a signal that may or may not be associated with the virus particles and then those virus particles may or may not be neutralized by mucosal antibody for example.

Scott Roberts: So there's a lot of RNA signals that may or may not be associated with virus particles, and then those virus particles may or may not be neutralized by neocosal antibody. So that's the disconnect between the RNA and the infectious virus. But I will know that on that slide, if you look at the infectious, replicating virus, you can see that two of the animals had no detectable replicating RNA either. And so we are really driving down the ability of the virus to replicate, and to the extent that we cannot find, in a very, very sensitive assay, any infectious virus present in the lungs of those animals. Okay, that's helpful, thank you.

That's the disconnect between the R&D and the and the infectious for us, but I will note that.

On that slide if you look at the infectious the replicating virus you can see that two of the animals had.

No.

No detectable reps.

Replicating R&D either and so so we are really driving down the ability of the virus to replicate and to the extent that we cannot find in a very very sensitive assay any infectious virus present in the lungs for those animals.

Okay. That's helpful. Thank you and then I guess the amount you're exposing the amount of virus or exposing the animals here was that.

Scott Roberts: And then I guess the amount you're exposing, the amount of virus you're exposing the animals to, is consistent with what you'd see if you went, you know, I mean, I'm just trying to understand how that relates to the real world. Probably much higher.

Consistent with what you'd see if you can you know I mean, I'm just trying to understand how that relates to real world, if Chicago being much higher probably channel.

Scott Roberts: Probably at a very high level. Okay. Yeah, yeah, much higher.

Okay Yeah.

Yeah for much higher I mean, and that's typically how the the challenge studies typically use you know around 10000 infectious units and that's that's in the range of what we're using here at various price experiment, but certainly around that that's probably a lot more than you're getting from somebody such needs or something like that.

Scott Roberts: I mean, and that's typically how challenge studies typically use, you know, around 10,000 infectious units. And that's in the range of what we're using here. It varies by experiment, but certainly around that.

Scott Roberts: That's probably a lot more than you're getting from somebody's sneeze or something like that. Okay, very helpful. And then as you kind of think about where we are with the pandemic and in terms of our availability of vaccines for an emergency use, we started to say that EUA, is that still something that you think is available for the next generation of vaccines, or do you think full approval is going to be in the cards? So how are you thinking about the regulatory strategy? Scott Harris, you want to take that? Hey Lisa.

Okay very helpful. Thank you.

And then as you kind of think about what's going on where we are with the pandemic and in terms of our availability of vaccines or the emergency use use authorization I'm sorry.

Always hard to say that ebay is that still.

You know something that you think is.

Available to sort of the next generation of vaccines or do you think a full approval is going to be.

In the current for how you're thinking about what the regulatory strategy.

Scott Harris, you want to take that.

Hey, Lisa.

Scott Harris: Um, there are differences between authorization and approval, but the major difference is the amount of follow-up or time. Typically, with approval, it's six months, but with authorization, it's only two months, and we're seeing that play out right now as the Pfizer vaccine is being filed for approval. Basically, the amount of safety data that you have, it's fairly clear that there's a need for a multitude of vaccines, even in the US, especially as the variants come out.

The there are differences between authorization approval for the major difference is the amount of follow up for time.

Typically with approval, it's six months, but with authorization, it's only two months and we're seeing that play out right now.

Besides for vaccine has been filed for approval, it's basically the amount of safety data that you have.

It's fairly clear that there is a need for a multitude of vaccines, even in the U S, especially as the variance come out.

Scott Harris: And more than likely, the FDA will adopt a strategy to keep pace with the emerging need, which is every day, and will probably continue to issue authorizations. That would be the prospect that we would see, but obviously that's up to the agency.

And more than likely the FDA will take the strategy.

To keep pace with the emerging need which is every day, we will probably continue to issue authorizations that would be the prospects that we would see but obviously that's up to the agency.

Okay.

Scott Harris: Okay. And then, As you're thinking about phase two as well, how are you thinking about variants for sort of, I guess, wild type diversity in that? Right.

And then.

As youre thinking about phase two as well how are you thinking about variance versus sort of the I guess debt.

Oh, well type areas and that's my last question. Thank you.

Right.

We have are in the process of manufacturing variance vaccines, I'll, let Scott talk or deeply into that but we will have that.

Scott Harris: We are in the process of manufacturing variant vaccines. I'll let Scott talk more deeply into that, but we will have that vaccine for a study toward the end of this year, and that will be a re-vaccination study or a study in previously infected individuals. So we've built out the entire variant program.

A vaccine for a study towards the end of this year and that will be a re vaccination study or a study in previously infected individuals. So we've built out the entire variant program. We're manufacturing the vaccine we will have it available and we will put it into a phase.

Scott Harris: We're manufacturing the vaccine. We will have it available, and we will put it in a phase two study to go along with our other phase two studies as outlined in the slides that have been presented. You know, I can go ahead and add to my perspective on that. You know, I think that, you know, we can imagine two scenarios.

Two study.

To go along with our other phase III studies as outlined in the slides.

That had been presented.

You know I can go ahead and a net my perspective on that.

Debt.

You know.

We can imagine two scenarios.

Scott Roberts: You know, as I indicated in the call, we're very keenly interested in the ability of the prototype COVID vaccine, which is directed against Wuhan and Islet, to neutralize in a very effective way the variance of concern. And that stems from the fact that our approach is fundamentally different from the majority of vaccines. We focused on the RBB, and that could bring interesting new antibody repertoires to the table, for example. So we certainly need to understand that. And in the context of variants that are mildly different. And that's how it really characterized the ones that are out there right; they're mildly different compared to the parental string. We'd have to see.

As I indicated in the in the call we're very keenly interested in the ability of the <unk>.

Prototypes at COVID-19 vaccine, which is directed against Wuhan.

Isolate.

To neutralize and a very effective way.

Variance of concern.

But and that stems from the fact that our approach is fundamentally different from the majority of the vaccines were focused on the RVP and that could bring interesting new antibody repertoire to the table. For example, so so we certainly need to understand that.

And then the context.

<unk> variance that are mildly different and that's how it really characterize the ones that are out there right now they are there.

Mildly different compared to the to the parental screen well.

Scott Roberts: There may be an opportunity to continue using the prototypic one, but we're not resting on that. We can't assume that that's going to be the case, and we can't assume that a variant that is really very different, a different serotype, for example, no longer neutralized at any level or something like that, or has clear enhancement of disease might come along. And so the importance of being able to match a vaccine to the variant is still vitally important.

We'd have to seek there maybe an opportunity to continue using the prototypical one but we're not resting on that we can't assume that that's going to be the case and we can't assume that a variant that is really <unk>.

Very different a different serotype for example, no longer neutralized on any level or something like that Mike <unk> has clear enhancement of disease might come along and so the the importance of being able to match a vaccine to the variance is still vitally important we're prepared for that.

Scott Roberts: We're prepared for that, and as Scott indicated, we're going to conduct the clinical studies that are required to show that when we make a variant, everything's behaving the same, the safety, and the immunogenicity. And that'll pave the way for responding in real time, as necessary for a variant that is really a departure from the prototypic strain of what might be circulating. So I think we've got, you know, two plays here.

And as Scott indicated we're going to conduct the clinical studies that are required to show that when we make a variant everything's behavior. The same for safety, the immunogenicity and that will pave the way for responding in real time.

It is necessary for a variant that debt that is really a departure from from the from the prototypic strain of what might be circulating. So I think we've got.

Two two for two plays here one involving the possibility that the prototypical provides protection sufficient and then one where we're clearly engaged on and able to execute where you do have the matched a very impacting for the variant that debt is at hand.

Scott Roberts: One involving the possibility that the prototypic provides sufficient protection, and then one where we're clearly engaged on and able to execute where you do have the matched variant vaccine for the variant that is at hand. Thanks. Thank you. Our next question comes from the line of Yuan Z with B-R-R-L securities.

At hand.

Thanks.

Thank you. Our next question comes from the line of with B Riley Securities. Please proceed with your question.

Yuan Z: Please foresee, Hi, this is Yuan. On my end, thank you for taking our questions. So can you provide some update on your preclinical rodent study you are conducting to study transmissions? And where do you think we are as a society in appreciating the residue on-mad needs that remain to be addressed, considering the widespread use or availability of EUA-approved vaccines and the now easing of the mask mandate? And also, can you provide some update on the T-COID program? And are there any learnings about that platform from that experience?

Hi. This is all for my answer thank you for taking our questions. So can you provide some update on your preclinical Rosen charter you are conducting two studies transformations and where do you think we are as a society.

Appreciate it ANZ, rather do all man needs for remains to be addressed considering the wider spreads you are all well relative to all the EU for vaccines and then now easing our Cmos mandates and also can you provide some update on the T. COVID-19 program and is there any learnings about for.

That's a platform from that experience. Thank you.

Scott Roberts: Thank you. Scott Roberts, do you want to go first? Sure. So with respect to the transmission study, those studies are ongoing, we're very much looking forward to those and to having clear data showing the ability of that COVID-to-block transmission, in the greater context, I think that the ability to effectively, and I should say most effectively, block transmission is still an important aspect of COVID, despite the clear indications that the authorized vaccines are having an effect on shedding, likely an effect on transmissibility, it's not at all clear that that effect is as strong as it could be, and that's something that you'd want in a second generation improved vaccine.

Scott Roberts do you want to go fast.

Sure.

So with respect to the.

Our transmission study that's that those studies are ongoing.

Very much looking forward to those and to having a clear data showing the ability of that growth with the black transmission.

And in the greater context.

Think that the ability to effectively and cash.

I would say most effectively blocked transmission is still an important aspect of COVID-19.

Despite the clear indications that the authorized vaccines are having an effect on shedding and likely an effect on on Transmissibility.

It's not at all clear that that effect is as strong as it could be and that's something that you'd want in a second generation improved vaccine. So when we think about COVID-19 and in the context of the EUA vaccines and what we're learning there we still see the advantages they improved tolerability and the potential for even.

Scott Roberts: So when we think about ad COVID in the context of the EUA vaccines and what we're learning there, it still has the advantages, the improved tolerability, and the potential for even better or best in class ability to block transmission. And as you indicate, with the masks off situation that we find ourselves in now, that is just as relevant now as it ever was. Now, let Scott Harris talk about COVID-Povic. Yes, and thank you for your question. Obviously, one of the learnings that we've had is the difficulty of trying to conduct these studies, and we've obviously affected the T-COVID study as well.

Better or best in class.

<unk> to block transmission and as you indicate with the masks off situation that we find ourselves in now that that is just as relevant now as it ever was and then I'll, let Scott Harris to talk about the COVID-19 program.

Yes, and thank you for your question.

Obviously, one of the learnings that we've had is the difficulty of trying to.

Conduct these studies and we've obviously, it's obviously impacted the T. COVID-19 study as well, we're continuing to enroll we're continuing to assess the readout, which is still scheduled in the second quarter in June.

Scott Harris: We're continuing to enroll patients. We're continuing to assess the readout, which is still scheduled for the second quarter of June, and if there's any change, we will inform our investors.

Was there any change to that based on the shifting dynamics will inform our investors.

Scott Harris: Thank you. That's a super help. Thank you. Ladies and gentlemen, that concludes our question and answer session. I'll turn the floor back to Dr. Garg for any questions. Thank you very much for joining us and participating on the call today. We hope you'll join us on our next quarterly earnings call. Have a nice day. Thank you. This Conclusive Ace Conference, you may disconnect your lines at this time. Thank you for your cooperation.

Thank you Vanessa Super helpful.

Thank you, ladies and gentlemen that concludes our question and answer session I will turn the floor back to Dr. Garg for any final comments.

Yeah.

Thank you very much for joining us and participating on the call today, we hope for.

He will join US on our next quarterly earnings call have a nice day.

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

Okay.

Yeah.

Yeah.

Yeah.