Q2 2021 Altimmune Inc Earnings Call

Excuse me, ladies and gentlemen. This is the operator today's conference is scheduled to begin momentarily until that time your lines will again be placed on music hold thank you for your patience.

Operator: Ladies and gentlemen, this is the operator. Today's conference is scheduled to begin momentarily. Until that time, your lines will again be placed on music hold. Thank you for your patience.

Music: [inaudible] ???

Operator: Good day, ladies and gentlemen, and welcome to the Altimmune Incorporated Q2 earnings conference call. At this time, our participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. If anyone should require operator assistance, please press the star, then zero on your touchtone telephone.

[music].

Good day, ladies and gentlemen, and welcome to the Alky Moon incorporated Q2 earnings Conference call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time, if anyone should require operator assistance. Please press Star then zero.

Key on your Touchtone telephone as a reminder, this call maybe recorded.

Operator: As a reminder, this call may be recorded. I would now like to introduce your host for today's conference, Will Brown, Chief Financial Officer of Altium. Well, you may be gone.

And I'd like to introduce your host for today's conference will Brown, Chief Financial Officer of out to Moon, where you you may begin.

Thank you operator, and good morning, everyone. Thank you for participating and all communes and second quarter 2021 earnings Conference call.

William Wood: Thank you, operator, and good morning, everyone. Thank you for participating in Altimmune's second quarter 2021 earnings conference call. Leading the call today will be Vipin Garg, our chief executive officer. I will also be presenting during the call, as well as 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 second quarter 2021 financial results was issued last night and can be found in the Investor Relations section of the company's website.

Leading the call today will be vipin garg, our chief Executive Officer, I will also be presenting during the call as well as Scot Roberts, our chief Scientific officer and.

Got Harris, our Chief Medical Officer.

Following the prepared remarks, we will hold a question and answer session and press release with our second quarter 2021 financial results was issued last night and can be found on the IR section 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 purposes of Safe Harbor provisions under the private Securities Litigation Reform Act of 1995.

William Wood: 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, cautioning that these forward-looking statements are subject to risk and uncertainty, which 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.

<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 these 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.

William Wood: For a discussion of some of these 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. I would also direct you to read the forward-looking statement disclaimer in our earnings press release issued yesterday and now available on our website. Any statements made on this conference call speak only as of today's date, Wednesday, August 11, 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 Altimmune's website. With that, I will now turn the call over to Dr. Vipin Garg, Chief Executive Officer of Altimmune.

I would also direct you to read the forward looking statement disclaimer and our earnings press release issued yesterday and now available on our website.

Any statements made on this conference call speak only as of today's date Wednesday August 11, 2021 and.

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.

Thank you Bill and good morning, everyone.

Vipin Garg: Thank you, Will, and good morning, everyone. We appreciate you joining us today for a discussion of our second quarter 2021 financial results and business update. I want to begin today's call by thanking our employees, our collaborators, and our investors for the tremendous dedication and support they have shown to Altimmune over the last 18 months. In January 2020, upon studying emerging reports of the devastating COVID-19 virus, our R&D team sprang into action in our labs and began creating a COVID-19 vaccine based on our intranasal platform technology. Our encouraging data from our Phase II clinical trials with Nasovax gave us confidence that an intranasal vaccine could be effective in protecting individuals against this new respiratory virus.

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

I want to begin today's call by thanking our employees.

Our collaborators and our investors.

But the tremendous dedication and support they have shown the oct immune over the last 18 months.

And January 2020, upon and studying the emerging reports of the devastating COVID-19 virus.

Our R&D team sprang into action and our labs and began creating and COVID-19 vaccine based on our Internet platform technology.

Our encouraging data with our phase II clinical trials with nasal vacs gave us confidence that and intranasal vaccine could be effective in protecting individuals' against this new respiratory virus.

Through the most uncertain days of the pandemic and quantum team our employees and collaborators.

Vipin Garg: Through the most uncertain days of the pandemic and quarantine, our employees and collaborators answered the call to this global crisis through extreme dedication to the task at hand that came with tremendous personal sacrifice of time with family and loved ones. I was proud and inspired by their resiliency and resolve.

Answer the call to this global crisis.

Through extreme dedication to the baskets hand that came with tremendous personal sacrifice of time with family and loved ones.

And was proud and inspired by their resiliency and resolved.

Through this work our confidence was bolstered that add COVID-19 could have great potential and the mucosal vaccine as the gather positive animal data, including with potent induction of local Newcastle and systemic immune responses.

Vipin Garg: Through this work, our confidence was bolstered that ADCOVID could have great potential as a mucosal vaccine as we gathered positive animal data, including a potent induction of local mucosal and systemic immune responses and demonstrated efficacy against the SARS-CoV-2 virus. However... Far too often in our business, we see product candidates that work extremely well in animals but do not translate to humans. And unfortunately, that was the experience we had.

And demonstrated efficacy against the soft Scooby Doo Vitus.

However.

Far too many times and our business, we see product candidates that work extremely well and animals, but do not translate to humans.

And unfortunately that was our experience.

We were extremely disappointed that the phase <unk> data.

Vipin Garg: We were extremely disappointed in the phase one data for COVID, and we have to take an honest look at the viability of performing continued experiments and clinical tests at a time when the mRNA and other vaccine approaches were working so very well, and during an efficient vaccine rollout and update great by the general public, that will surely stand as a remarkable achievement in the history of vaccine development. We applaud the efforts of the global pharmaceutical community in swiftly developing these new vaccines with this backdrop of success and always seeking to be good stewards of the resources entrusted to us.

And we have to take and honest look at the viability of performing performing continued experiments and.

And clinical cash.

At the time, when the modern day and other vaccine approaches working so very well.

And during and efficient vaccine rollout and update right by the general public.

That will surely be shortly and as a remarkable achievement and the history of vaccine development.

We applaud the efforts of the global pharmaceutical community.

And swiftly developing these new vaccines.

With this backdrop of success and.

And always seeking to be good stewards of the resources and trusted to us.

We've made the decision to terminate the App Covid program.

As you have heard US say many times one of the central tenets of our philosophy is to maintain and develop and diversified portfolio of assets to ensure that we are positioned for success.

Vipin Garg: We made the swift decision to terminate the ad COVID program, as you have heard us say many times. One of the central tenets of our philosophy is to maintain and develop a diversified portfolio of assets to ensure that we are positioned for success, no matter what happens with any one of our product candidates.

No matter, what transpired with one with any one of our product candidates.

And that philosophy has served us well in 2020 volume with the clinical development of Alt 801.

Our <unk>, one glucagon dual agonist for the treatment of obesity and Nash.

As Scott Harris will more fully described we saw significant weight loss and just six weeks in our phase one study with.

Vipin Garg: Their philosophy has served us well in 2021 with the clinical development of ALT801, our GLP-1 glucagon dual agonist for the treatment of obesity and NASH. As Scott Harris will more fully describe, we saw significant weight loss in just six weeks in our Phase I study with no serious GI side effects. This fuels our enthusiasm and excitement for Alt-801 especially in light of the recent successful commercial launch of semaglutide for the treatment of obesity.

And with no Cvs Gi side effects.

This fueled solid enthusiasm and excitement for all day one.

Especially in light of the recent successful commercial launch of <unk> for the treatment of obesity.

It's further encouraging to compare our six week interim results.

Against other phase one clinical trials with similar agents.

Noting that we had at the top of the class in terms of weight loss and Tolerability at six weeks.

And without the need for dose titration.

With this data and begin the confidence to launch and additional program with Alt 801, and obesity and.

And we expect to file an IND and the fourth quarter to enable a phase II trial in obesity.

Which will follow our previously announced IMD for Nash and the third quarter.

Vipin Garg: It's further encouraging to compare our six-week interim results against other phase 1 clinical trials with similar agents and note that we are at the top of the class in terms of weight loss and tolerability at six feet, and without the need for those titrations. With this data, we gained the confidence to launch an additional program with ALT801 in obesity, and we expect to file an INB in the fourth quarter to enable a phase two trial in obesity, which will follow our previously announced IND for NASH in the third quarter, for the remainder of 2021.

For the remainder of 2021.

We look ahead to our phase one alt $801.12 week data.

From Australia, which was which.

We anticipate reporting and September.

Following this trial are several studies to further explore the effects of our drug and natural D.

And diabetic subjects, along with their study to test the interaction of Alt 801.

Drugs, commonly administered Dolby and diabetic subjects.

These studies will enable meaningful phase II trials, and both Nash and obesity with large studies planned to begin in early 2022.

Our other asset within deliver spaces Hep D cell and.

And immuno therapeutic for chronic hepatitis b.

That is in phase II development.

We haven't had b cell and one of the most clinically advanced immunotherapies and candidates and.

And we are in the midst of executing on this international trial.

We currently have sites and Canada U S, Germany, and Spain to follow up patients and a six month dosing regimen.

Vipin Garg: We look ahead to our Phase 1 ALT801 12-week data from Australia, which we anticipate reporting in September. Following this trial are several studies to further explore the effects of our drug in NAFLD and diabetic subjects, along with a study to test the interaction of ALT801 with drugs commonly administered to obese and diabetic subjects. These studies will enable meaningful phase 2 trials in both NASH and obesity, with large studies planned to begin in early 2022.

Considering the time to enroll HBV patients and discover the environment and the duration of dosing.

We expect to have data and the second half of next year.

So in Q3.2021, we'll now turn the page to the next chapter of $40 million.

With our focus firmly on obesity Nash and chronic hepatitis b.

And with exciting drug candidates and then enviable cash position.

With which we can quickly advanced through several near term data catalyst.

With that I'll now turn the call over to Scott Harris and.

And discuss our six week data.

The upcoming 12 week data readout and subsequent advanced trials Scott.

Thank you vipin and good morning, everyone.

During June we shared results from our six week interim analysis of two cohorts from the ongoing 12 week phase one placebo controlled single and multiple ascending dose study of Alt 801.

The study is being conducted in Australia and is enrolling overweight and obese volunteers.

Vipin Garg: Our other asset within the liver space is hepatitis C, and Immunotherapeutics for Chronic Hepatitis B, which is in Phase 2 development. We have in happy cell one of the most clinically advanced immunotherapeutic candidates, and we are in the midst of executing on this international trial. We currently have sites in Canada, the U.S., Germany, and Spain to follow patients for a six-month dosing regimen. Considering the time to enroll HPV patients in this COVID environment and the duration of dosing, we expect to have data in the second half of next year.

We reported two dose levels, one two and one eight milligrams that were administered subcutaneously once a week for six weeks.

The six week dare to reported weight loss and adverse events.

The results, we observed were very encouraging and have exceeded our pre established treatment target of 2% absolute weight loss at six weeks.

Employing a one eight milligram subcutaneous once weekly dose.

We achieved a placebo adjusted mean weight loss of six 3% and just six weeks of treatment with Alt 801.

During the six weeks Alt 801 was well tolerated with low rates of nausea, and other Gi side effects and importantly, there were no patient dropouts and the $1 eight milligram dose level and the one patient at the one two milligram dose the dropped out did so for.

Vipin Garg: So in Q3 2021, we now turn the page to the next chapter of Altium with our focus formally on obesity, NASH, and chronic hepatitis B with exciting drug candidates and enviable cash positions with which we can quickly advance through several near-term data catalysts. With that, I'll now turn the call over to Scott Harris to discuss our six-week data, the upcoming 12-week data readout, and subsequent advanced trials. Scott? Thank you.

For reasons unrelated to drug.

This is particularly remarkable given the fact that we administered <unk> <unk> without the use of dose titration, which is the practice with virtually all other agents and the class, including the reached recently launched with <unk>.

Gastrointestinal adverse events that are required and these other GOP have required. These other <unk> based candidates to dose titrate that is to achieve the therapeutic dose only after slowly increase from the doses over 16 to 20 weeks to maintain adequate tolerability.

While the six week day to focus on weight loss and adverse events and we will certainly report these measures.

And with the 12 week data we plan to also report data on a number of other measures, namely pharmacokinetics lean body mass caloric intake resting energy expenditure.

Coastal homeostasis insulin resistance lipids and inflammatory markers.

Scott Harris: Thank you, Vipin, and good morning, everyone. In June, we shared results from our six-week interim analysis of two cohorts from the ongoing 12-week Phase I placebo-controlled single and multiple ascending dose study of ALT801. The study is being conducted in Australia and is enrolling overweight and obese volunteers. We reported two dose levels, 1.2 and 1.8 milligrams, that were administered subcutaneously once a week for six weeks. The six-week data reported weight loss in adverse events.

We believe that the one eight milligram dose is likely to the level at which at which.

And we show the most attractive combination of efficacy safety and Tolerability. However, we're testing higher dose cohorts and the ongoing trial and today, we announced that we will be reporting 12 week dosing results for the one two milligram one eight milligram and two four milligram.

Gram dose levels, we recently completed dosing and these groups and we will take approximately four weeks to analyze and report the data.

Accordingly, we expect to report the 12 week data on these cohorts and September and we look forward to sharing this data with you.

Looking ahead to further development, we are planning three additional trials to initiate this year.

These trials are designed to address key questions regarding the activity of all tier one early and the drugs development.

First we are and the process of filing an alt 800.

One <unk> and Nash.

Scott Harris: The results we observed were very encouraging and exceeded our pre-established treatment target of 2% absolute weight loss at 6 weeks, employing a 1.8 milligram subcutaneous once-weekly dose. We achieved a placebo-adjusted mean weight loss of 6.3% in just six weeks of treatment with Alt-801. During the six weeks, ALT801 was well tolerated with low rates of nausea and other GI side effects. Importantly, there were no patient dropouts at the 1.8 mg dose level, and the one patient at the 1.2 mg dose that dropped out did so for reasons unrelated to the drug.

To conduct a 12 week phase <unk> study of subjects with nonalcoholic fatty liver disease or natural D and the United States.

This study will expand the enrollment criteria used and the aforementioned first in human study and Australia to include diabetic and older subjects and commence around the end of September.

Based on the relationship between weight loss and liver fat reduction observed in other <unk> based studies and the additive effects of glucagon on liver fat metabolism. We are optimistic that alternative one will be and effective therapeutic Asian for Nash and that the reduction in liver fat and the play.

And 12 week NASA <unk> study will parallel the impressive weight loss that we have observed.

Second we are planning to initiate a dedicated type two diabetes trial to started glucose homeostasis and diabetics and Q4.2021.

The study will be 12 weeks and duration and we will study endpoints.

That will include continuous glucose monitoring.

Hemoglobin <unk> C and measures of insulin resistance, such as homa, IR too and Adiponectin.

We expect the observations of glucose control and our current Australia and 12 week study to hold two true for the type two diabetes population is overweight and obese subjects like patients currently enrolled.

Scott Harris: This is particularly remarkable given the fact that we administered ALT801 without the use of dose titration, which is the practice with virtually all other agents in the class, including the recently launched Wagovi. Gastrointestinal adverse events that have required these other GLP1-based candidates to dose titrate, that is, to achieve the therapeutic dose only after slowly increasing the doses over 16 to 20 weeks to maintain adequate tolerability. While the six-week data focused on weight loss and adverse events, and we will certainly report these measures with the 12-week data, we plan to also report data on a number of other measures, namely pharmacokinetics. Lean Body Math.

Typically exhibit insulin resistance and pre diabetes.

Since later stage Nash and obesity trials will likely include type two diabetics, we want to establish this conclusively.

Finally, we are planning to initiate a drug drug interaction trial.

The FDA is expected sponsors and <unk> based compounds to conduct studies evaluating the impact of alterations with gastric emptying on the kinetics of drug absorption.

<unk> based compounds with extended half lives like all tier one and have not been associated with these changes.

Alt 801 is a peptide. So there is no significant interactions with cytochromes are transporters and have been observed to date or are expected.

As previously announced we plan to file a second IND.

For Alt 801 in obesity during the fourth quarter to create a parallel development plan path to our ongoing Nash development.

This indeed.

And the aforementioned trials will enable significant phase II clinical development during 2022.

Scott Harris: Galorkin to, Resting Energy Expenditure, Glucosomiasasis, Insulin Resistance, Lipids, and Inflammatory Markers. We believe that the 1.8 mg dose is likely the level at which we show the most attractive combination of efficacy, safety, and tolerability. However, we are testing higher dose cohorts in the ongoing trial, and today we announced that we will be reporting 12-week dosing results for the 1.2 mg, 1.8 mg, and 2.4 mg dose levels. We recently completed dosing in these groups, and it will take approximately four weeks to analyze and report the data. Accordingly, we expect to report the 12-week data on these cohorts in September, and we look forward to sharing this data with you.

At this time, we are planning a phase II obesity study along with a fee phase 252 week biopsy, driven Nash study, which could start and the first quarter of 2022, we look forward to updating you on our phase III plans later this year.

It's also you don't want is currently administered as a subcutaneous injection or development plan plan and <unk> includes the use of an auto injector that can be self administered by patients and work is progressing on that front equally.

Equally important we have initiated development of an oral formulation for altria to one <unk>.

I'll turn it over to Scott Roberts, our Chief Scientific officer for that discussion Scott.

Thank you Scott.

One of the advantages we have with a molecule like all day to one is that it is an attractive candidate for oral formulation.

Several of the blip one based drugs currently in development are not suitable for oral formulation owing to their large size.

As Alt data one is structurally similar to <unk>, which has been successfully formulated for oral administration.

We are optimistic about the eventual success of and Alt 801 oral formulation.

We view and oral formulation of Alt 801, similarly to our improved tolerability profile and our ability to bypass protracted dose titration.

Advantages that increased patient interest and compliance.

Scott Harris: Looking ahead to further development, we are planning three additional trials to initiate this year. These trials are designed to address key questions regarding the activity of Altaida 1 early in the drug's development. We are in the process of filing an ALT801 IND in NASH to conduct a 12-week Phase I-B study of subjects with non-alcoholic fatty liver disease, or NAFLD, in the United States. This study will expand the enrollment criteria used in the aforementioned First in Human Study in Australia to include diabetic and older subjects and commence around the end of September.

We look forward to updating you on our progress toward this endeavor and the near future.

Finally.

I would also like to provide a brief update on our chronic toxicology studies designed to support our longer term obesity and Nash efficacy studies.

The studies are progressing well.

And with overall observations consistent with the earlier shorter duration studies and we expect these studies to be completed and the fourth quarter to support the phase to obesity and Nash trials planned for 2022.

I will now hand, the call over to will brown to give an update on our second quarter financial results.

Thank you Scott and for today's call I'll be providing a brief update on ultimate and second quarter 2021 financial and operating results.

More comprehensive information can be found in our form 10-Q filed with the SEC last night.

Scott Harris: Based on the relationship between weight loss and liver fat reduction observed in other GLP-1-based studies and the additive effects of glucagon on liver fat metabolism, we are optimistic that Alt-801 will be an effective therapeutic agent for NASH and that the reduction in liver fat in the planned 12-week NAFLD study will parallel the impressive weight loss that we have observed. Second, we are planning to initiate a dedicated type 2 diabetes trial to study glucose homeostasis in diabetics in Q4 2021. The study will be 12 weeks in duration, and we'll study endpoints. That will include continuous glucose monitoring. Hemoglobin A1c, and measures of insulin resistance such as HOMA-IR2 and adiponectin.

Ultimate ended the second quarter with a strong cash position reporting and balance of approximately 218 million and cash cash equivalents and short term investments compared to $216 million at the end of 2020.

The increase and our net cash during the current period is attributable to $52.4 million of net receipts during the year, primarily due to our utilization of yet the market or ATM offering program.

All set by cash use for operating and investing activities.

With these resources and the termination of the AD Covid vaccine program, we have sufficient cash to operate into 2023.

Turning to the income statement revenue and the second quarter was 137000 compared to 720000.

And the second quarter of 2020.

The change and revenue between periods is primarily due to a decrease and BARDA revenue.

And as we wind up activities under the current and maintenance contract.

Revenue attributable to the Covid program was completely recognized as of the end of Q1 and we are currently collecting the related accounts receivable as we complete the activities under that contract.

Research and development expenses were $13.3 million and the second quarter compared to $16.6 million and the prior period.

The change and R&D expense was primarily the result of $13 million and higher non cash charges into.

Scott Harris: We expect the observations of glucose control in our current Australian 12-week study to hold true for the type 2 diabetes population as overweight and obese subjects, like patients currently enrolled, typically exhibit insulin resistance and prediabetes. Since later-stage international obesity trials will likely include type 2 diabetics, we want to establish this conclusively. Finally, we are planning to initiate a drug-drug interaction trial. The FDA has expected sponsors of GLP-1-based compounds to conduct studies evaluating the impact of alterations of gastric emptying on the kinetics of drug absorption. GLP-1-based compounds with extended half-lives, like Alt-801, have not been associated with these changes.

And the prior period related to changes and the fair value of contingent consideration liability connected with the acquisition and development of all day to one.

This was offset by an increase of $10 million related to development activities for at Covid and other programs.

General and administrative expenses were $3.7 million and the second quarter of 2021 compared to $2.5 million and the prior period, primarily due to increased stock comp expense and additional labor related costs.

We recognized approximately an $8 million impairment losses impairment loss on construction and process.

During the second quarter, which represents an impairment charge recorded for assets that were previously capitalized and connection, but the manufacturing suite under construction and Alonso.

We have not yet terminated that contract and we are currently evaluating our options with respect to this space.

Net loss for the three months ended June 32021 was $24.8 million or 60.

Net loss per share compared to $16.8 million or <unk> 94, net loss per share for the second quarter of 2020.

Scott Harris: Alt-801 is a peptide, so no significant interactions with cytochromes or transporters have been observed to date or are expected. As previously announced, we plan to file a second IND for ALT801 in obesity during the fourth quarter to create a parallel development path to our ongoing NASH development. This IND and the aforementioned trials will enable significant phase 2 clinical development during 2022. At this time, we are planning a Phase 2 obesity study, along with a Phase 2 52-week biopsy-driven NAST study, which could start in the first quarter of 2022.

The difference and net loss is primarily attributable to higher R&D impairment and G&A expenses.

I will now turn it back over to Vince and for his closing remarks. Thank.

Thank you Bill.

Operator that concludes our formal remarks.

And we would like to open the lines to take questions could you. Please instruct the audience on the Q&A procedure.

Yes at this time, ladies and gentlemen, and if you would like to ask and audio question.

Press Star then the number one and all your telephone keypad. Once again that is start and any number one and for your question has been answered and to remove yourself from the queue. Please press the pound key we will pause for just a moment to compile the Q&A roster.

Your first question will come from the line of Seamus Fernandez with Guggenheim.

Great. Thanks, so much for the questions.

So.

And I appreciate the update.

The update.

And it relates to the plans for.

Scott Harris: We look forward to updating you on our Phase 2 plans later this year. As ALT801 is currently administered as a subcutaneous injection, our development plan includes the use of an auto-injector that can be self-administered by patients, and work is progressing on that front. Equally important, we have initiated the development of an oral formulation for ALT-801.

The obviously.

The historical program now from a vaccine perspective, as you guys pivot to <unk>.

Really driving the company towards being a metabolic disease company.

And we've obviously seen the robust performance at six weeks I think.

And there would be helpful to just understand.

And what you're hoping to see specifically.

Scott Roberts: I'll turn it over to Scott Roberts, our Chief Scientific Officer, for that discussion. Scott? Thank you.

And the 12 week data and then in terms of the two four milligram dose I think thats right in line with our expectations for where you would increase the dose to.

Scott Roberts: One of the advantages we have with a molecule like Alt-Data-1 is that it is an attractive candidate for oral formulation. Several of the GLP1-based drugs currently in development are not suitable for oral formulation owing to their large size. As ALTdata1 is structurally similar to semaglutide, which has been successfully formulated for oral administration, we are optimistic about the eventual success of an Alt 801 oral formulation. We view an oral formulation of ALT801 similarly to our improved tolerability profile and our ability to bypass protracted dose titration.

Again, I think most cases.

The increase and the dose would be 30% to 50% so.

In line with expectations, but how should we think about the.

The relative opportunity for the two four milligram dose is this really and exploration.

Of the sort of.

The upper dose range more than anything or is it your hope that you could see incremental weight loss above and beyond what we've already seen it six weeks with the one eight milligram dose or is your expectation to really see more of a trade off of Tolerability.

Scott Roberts: Advantages that increase patient interest and compliance. We look forward to updating you on our progress toward this endeavor in the near future. Finally...

Given the contributions of <unk> to the mechanism and then I have a follow up question on your oral approach.

Relative to the kind of technology.

William Wood: I would also like to provide a brief update on our chronic toxicology studies designed to support our longer-term obesity and NASH efficacy studies. The studies are progressing well with overall observations consistent with the earlier shorter duration studies, and we expect these studies to be completed in the fourth quarter. Support, The Face to Obesity, and NASH Trials Planned for 2022. I will now hand the call over to Will Brown to give an update on our second quarter financial results.

That's necessary to deliver a peptide orally.

Absolutely well. Thank you Seamus Scott had asked do you want to take that good morning Seamus.

And.

Our expectation for the 12 week data is that we'll continue to see a strong trend and weight loss, we have been picked and actual number I think the most important number is what we achieve say at 40 to 52 weeks, we did posted on our corporate website, the individual responses, which show the trends.

And the dosing. So we would project that those trends would continue through 12 weeks, which would signify those trends would probably continue to week 52.

William Wood: Thank you, Scott. On today's call, I will be providing a brief update on Altimune's second quarter 2021 financial and operating results. More comprehensive information can be found in our Form 10-Q filed with the SEC last night. Altimmune ended the second quarter with a strong cash position, reporting a balance of approximately $218 million in cash, cash equivalents, and short-term investments, compared to $216 million at the end of 2020. The increase in our net cash during the current period is attributable to $52.4 million of net receipts during the year, primarily due to our utilization of the At-The-Market, or ATM, offering program, all set by Cash Use for Operating and Investing Activities. With these resources and the termination of the ad-COVID vaccine program, we have sufficient cash to operate into the future.

And that would be our expectation.

And we'll also as you know.

Much more data that will be more and mechanistic such as calorie intake resting energy expenditure and lean body mass and schools glucose homeostasis and they will not only project the efficacy of the compound, but really understand it and understand what we're achieving with dosing.

Regarding the two four milligram dose as you know the dose the results that we achieved with one eight milligrams, which is less and two four were already in our opinion and spectacular. So it really didnt leave much to gain by dosing higher in terms of more weight loss.

And as we announced the primary reason to dose higher.

Was to establish the dose range.

And we could work.

As you go to phase II, you don't want to have phase one obligations and if we hadn't dose higher and for whatever reason decided to go to the dose later, we'd have to go back and do another phase one study where make a phase III study look like for phase one.

So.

And I think what we're really shooting for is greater tolerability.

With me the range of Tolerability.

<unk>.

And the accepted safety range, rather than achieving higher weight loss now if we achieve higher weight loss that would be great, but it would be hard to believe that we can achieve much higher weight loss and we have got with one eight milligrams.

Inaudible: [inaudible]

William Wood: Turning to the income statement, revenue in the second quarter was $137,000 compared to $720,000 in the second quarter of 2020. The change in revenue between periods is primarily due to a decrease in BARDA revenue as we wind up activities under the current native shield contract. Revenue attributable to the TCOVID program was completely recognized as of the end of Q1, and we are currently collecting the related accounts receivable as we complete the activities under the

And just I guess on the or.

And all that technology.

That would need to be employed or can be employed to.

To deliver.

This peptide technology.

Just hoping to get a better understanding of that I think.

Our understanding the atmosphere technology is now a 100% owned.

Bye bye.

And by no minority.

And it was only a single amino acid change between Liraglutide and.

And similarly tied that actually allowed for that products too.

Be delivered and and bioavailability I think it's still to some day question for that product. So just love to know that the technical approach that you're taking and.

Inaudible: [inaudible]

William Wood: Research and Development expenses were $13.3 million in the second quarter, compared to $16.6 million in the prior period. The change in R&D expense was primarily the result of $13 million in higher non-cash charges in the prior period related to changes in the fair value of continued consideration liability connected with the acquisition and development of Alt-801. This was all set by an increase of $10 million related to development activities for AddCOVID and other programs.

And if you've licensed <unk> technology to be able to do that and if so.

Wouldn't mind, disclosing which technology that are thank you.

Scott Roberts sure Hey, Seamus so.

And one of the things that we saw write off when we are acquiring Alt 801 was its suitability potential suitability for formulation and.

With the with the six week data.

Validating the potency of this compound for weight loss, and presumably get and mobilizing fat out deliveries will see and the <unk> study I think that that only becomes more important and more and more reality for us. So we're very excited about this project.

At a general level the hurdles that have to be surrounded by anybody is trying to make a peptide orally bio available to us is to get it through the stomach first of all and protected from from proteases.

William Wood: General and administrative expenses were $3.7 million in the second quarter of 2021 compared to $2.5 million in the prior period, primarily due to increased dot-comp expense and additional labor-related costs. We recognized approximately an $8 million impairment loss on construction and process during the second quarter, which represents an impairment charge recorded for assets that were previously capitalized in connection with the manufacturing suite under construction at Lonza. We have not yet terminated that contract, and we are currently evaluating our options with respect to the space.

And then essentially you need to create a lipophilic environment for for the peptides. So that it can then cross sell.

The cell membrane and the intestine and enter the bloodstream and do its work. There. So there are a number of approaches obviously novo nordisk is use the snack technology to to achieve this.

I'm not going to go into a lot of detail about our approaches that we're looking at here, we'll update you and the future but.

Suffice it to say that the similarity of our molecule to <unk> that is a small with the lipophilic chain.

And of Linzess to to believe that we have.

The likelihood of success here. So we look forward to updating you that and the near future.

Great and entertainment and <unk> on a debt yes.

And that yes. Indeed, we are looking at a proprietary technology to make this work.

At this point, we will disclose it at the appropriate time.

And on.

Okay, great I'll jump back in the queue.

And out of respect for the other.

Other analysts on the call.

Your next question will come from the line of Yasmin Rahimi with Piper Sandler.

Thanks, Tim and thank you so much for taking my questions and thank you for the update.

Few for you maybe a good place to start with beaches.

William Wood: The net loss for the three months into June 30, 2021 was $24.8 million, or $0.60 net loss per share compared to $16.8 million, or $0.94 net loss per share, for the second quarter of 2020. The difference in net loss is primarily attributable to higher R&D, impairment, and G&A expenses. I will now turn it back over to Vipin for his closing remarks.

Providing us with some color on the site.

And how many patients from cohort, we should be seeing data and I went back to your corporate deck and.

First to that.

<unk> tended to be 100 patients and nicely. So the pace <unk> paste and weight loss and a 100.818 milligram, which is nine patients and foreign placebo. So as we head into September can you draw can you provide a color from me.

Vipin Garg: Operator, that concludes our formal remarks, and we would like to open the lines to take questions. Could you please instruct the audience on the Q&A procedure?

How many patients are and how many are within each of the three dose cohort.

It'd be very helpful. And then I have two follow ups for am.

Operator: Yes, at this time, ladies and gentlemen, if you would like to ask an audio question... Press star, then the number one on your telephone keypad. Once again, that is star, then the number one.

Yes, and good morning. So we are enrolling 10 to 15 per cohort and the randomization ratio between those who receive all total one and those who received placebo is 401, so it obviously varies a bit between.

Operator: If your question has been answered and you want to remove yourself from the queue, please press the pound key. We will pause for just a moment to compile the Q&A roster. Your first question will come from the line of Seamus Fernandez with Guggenheim. Thanks so much for the questions.

Cohorts, but that would be the general advice that we give.

Okay.

Another question for you.

Around expectations and weight loss going into until 12. So when we look at historical data comparing weight loss and and overweight population that is non diabetic you see the magnitude to be twofold.

Seamus Christopher Fernandez: So, appreciate the update as it relates to the plans for, [inaudible] And then, in terms of the 2.4 milligram dose, I think that's right in line with our expectations for where, you know, you would increase the dose. Again, I think in most cases, the increase in a dose would be 30 to 50 percent. So, you know, right in line with expectations.

Yeah.

Why can we not make the assumption maybe.

And maybe correct me wrong, Youre getting 6% at week six.

Should you be getting at least over 10% at week 12, and the significance of that.

Is there a chance that that might not fall in and that there is not a linear relationship between week six and at least 12. So if you could just comment on that debt that would be helpful.

Seamus Christopher Fernandez: But how should we think about the relative opportunity for the 2.4 milligram dose? Is this really an exploration of the – you know, sort of the upper dose range more than anything? Or is it your hope that you could see incremental weight loss above and beyond what we've already seen at six weeks with the 1.8 milligram dose? Or is your expectation to really see more of a trade-off of tolerability given the contributions of GLP-1 to the mechanism? I have a follow-up question on your oral approach relative to the kind of technology that's necessary to deliver a peptide orally.

Alright.

So I think the most important thing is to the Oi and the trends are continuing.

We focus on specific numbers.

Especially with small numbers we may.

It may not really get the right impression and so I think the most important thing is it visually when you look at the data you are convinced that it's linear.

And that is continuing and then we don't actually cite a specific number and we think that that will be the right approach or just don't want us to get hung up on a decimal place for success.

Thank you and then can you come and gone as of right now and any.

And what are your discontinuation rates have been and.

And when you reported six six data there was one patient that discontinued and be able to comment on sort of the discontinuation rate asset right now.

Vipin Garg: Absolutely. Well, thank you, Seamus. Scott Harris, do you want to take this?

Scott Harris: You'll want to take that. Good morning, Seamus.

Yes, we have met and public we havent been public on that Jasmine, and we obviously well with the 12 week data.

Scott Harris: Thank you. Our expectation for the 12-week data is that we'll continue to see a strong trend in weight loss. We haven't picked an actual number yet. I think the most important number is what we achieve, say, at 40 to 52 weeks. We did post on our corporate website the individual responses, which show the trends in the dosing. So we would project that those trends would continue through 12 weeks, which would signify that those trends would probably continue to week 52. And that would be our expectation.

Okay, and then I just wanted to understand maybe.

The thought process behind I know you are you had said that youre, starting a 52 week Nash study and the first quarter and.

As of right now is the 52 week Tox package complete or what is.

And at what point are you and so that Youre on track as soon as it is clear to kick off the 52 week data.

We're going to be at low not clear to me.

So let's go through the timeline quickly the IND for Nash will be filed imminently.

As Scott mentioned during his presentation.

Scott Harris: And we'll also, as you know, have much more data that'll be more mechanistic, such as calorie intake, resting energy expenditure, and lean body mass, as well as glucose homeostasis that'll not only project the efficacy of the compound but really understand it and understand what we're achieving with dosing. Regarding the 2.4 milligram dose, as you know, the dose, the results that we achieved with 1.8 milligrams, which is less than 2.4, were already, in our opinion, spectacular.

Have completed obviously.

And.

Good.

Talks up to 13 weeks and enables our 12 weeks of dosing and we are and the process of completing the chronic.

And so no talks that will enable a long term Nash study so that will be completed later this year well in advance debt Tox study will be completed later this year well in advance of either a 52 week Nash trial or a long term obesity trial. So there is a comfortable timeline there.

That we feel comfortable about hitting.

Okay, Thanks, and I'll jump into the queue. Thanks.

Your next question will come from the line of Kelly <unk>.

And with Jefferies.

Good morning, and thank you.

Two questions on my and I guess based on the current preclinical and clinical data is your expectation that you would use the same dose and both Nash and obesity, just trying to get a sense of debt given that people who've gone component of 801 has.

Scott Harris: So it really didn't leave much to gain by dosing higher in terms of more weight loss. As we announced, the primary reason to dose higher was to establish the dose range within which we could work. As you go to Phase II, you don't want to have Phase I obligations, and if we hadn't dosed higher and for whatever reason decided to go to that dose later, we'd have to go back and do another Phase I study or make a Phase II study look like a Phase I. I think what we are really shooting for is greater tolerability, excuse me, the range of tolerability, and the accepted safety range rather than achieving higher weight loss.

Has beneficial effects on the liver so just trying to I'm trying to determine there what the dose could potentially be.

Right. So the initial answer that question and <unk> would be yes, we do expect the doses to be similar but you brought up a good point, the glucagon has independent and effects over weight loss and potentially the dose and Nash could be lower but recognize that when you are treating nash and not just treating liver youre treating the whole patient.

So the.

We would think that we would try to administer doses to Nash patients that would not only achieve optimal fat reduction and deliver but also optimal weight loss because of the non hepatic comorbidities.

Got it. Thank you that's very helpful and I guess my second question Big picture wanted to get your latest thoughts on the development and potential commercialization of <unk> hundred one and these two large indications I guess, particularly as it relates to partnering is that a possibility are you having those discussions right now.

Scott Harris: Now, if we achieve higher weight loss, that would be great, but it would be hard to believe that we could achieve much higher weight loss than we have achieved with 1.8 milligrams. And just, I guess, on the oral, the technology that would need to be employed or can be employed to deliver this peptide technology. Just hoping to get a better understanding of that. I think, to our understanding, the Emysphere technology is now 100% owned by Novo Nordisk, and it was only a single amino acid change between liraglutide and semaglutide that actually allowed for that product to be delivered, and bioavailability, I think, is still, to some degree, a question for that product. I would love to know the technical approach that you're taking, and if you've licensed any technology Thank you.

And based on those discussions if youre, having them do you have a sense of the type of data the type of data partners are hoping to see.

Hey, <unk> bin.

Yes, and in terms of.

Thinking long term strategically as you can see the kind of trial that we are designing our goal is to onset as many critical questions as possible and the idea and released to build significant value and this asset quickly.

At this point, we just have phase one data from six weeks, obviously 12 week data is important but then we've designed and number of studies that will answer some critical questions. We do know one thing. We do know is that there is significant interest and assets like this from from large players from strategic partners I can name a dozen companies.

That would be interested in this so at this point, we are keeping all our options open.

And a good position to execute on this plan. So we've got a lot of Optionality and we will continue to monitor the situation.

Our goal is to.

<unk> increased the value of this asset over the next 12 months, let's say 12 to 18 months and as more data becomes available.

We are debt has no doubt that that would be interest and an asset like this from from multiple players.

Got it got it that's very helpful. Thank you.

Scott Roberts: Sure. Hey, Seamus.

Your next question will come from the line of Myanmar.

Scott Roberts: So, the... One of the things that we saw right off when we were acquiring Alt-801 was its, you know, suitability, potential suitability for oil formulation. And, you know, with the six-week data validating the potency of this compound for weight loss and presumably getting mobilizing fat out of the liver, as we'll see in the NIFLD study, I think that that only becomes, you know, more important and more reality for us.

With B Riley Securities.

Thank you good morning team. Thanks for taking my question and I appreciate the resilience and data driven approach to advancing your pipeline. So just quickly on the.

<unk> hundred one program.

Could you, maybe just gum and done whether six week zero.

<unk> built and look for the six week to point toward make dose level or are you just going out to the 12 week debt.

There was no and debt and analysis.

Alright clarity there was no interbank.

Oh, I'm sorry, Mike.

Scott Roberts: So, we're very excited about this project. At a general level, the hurdles that have to be overcome by anybody who's trying to make a peptide orally bioavailable are to get it through the stomach, first of all, and protect it from proteases. And then, essentially, you need to create a lipophilic environment for the peptide so that it can then cross the cell membrane in the intestine and enter the bloodstream and do its work there.

And Mike There was no interim analysis on the six week interim analysis and the two four milligram dose.

I understood and then on the trying to.

And the expectation for the phase II B.

Excuse me the 12 week Nash study.

And what could be gleaned out of this strategy.

Obese non diabetic patients if anything.

And what their baseline LSC liver enzymes might be.

And should we be expecting should we looking to learn anything on <unk> for example from from disclosing carried out in September.

Right.

Scott Roberts: So, there are a number of approaches. Obviously, Novo Nordisk has used SNAC technology to achieve this. I'm not going to go into a lot of detail about our approaches that we're looking at here. We'll update you in the future, but suffice it to say that the similarity of our molecule to semaglutide, which is small and has a lipophilic chain, lends us to believe that we have a high likelihood of success here. So, we look forward to updating you on that in the near future.

No.

I'll start by saying that we think the results from this study.

I will translate.

Translate.

Two other populations, we know that.

Based on the page the subject profile their age and BMI.

Attributes have translated and.

The <unk> trials.

Two very good results.

But long term readouts, we did not assess liver fat content.

In this trial, so I really can't comment on that and because this is not a nash population.

Vipin Garg: And Seamus, I can just add that, indeed, we are looking at proprietary technology to make this work, but at this point, you know, we'll disclose it at the appropriate time later on.

I wouldn't expect that we would have enough baseline IOP elevations to make.

Much of a signal or make much sense.

Of something that would predict.

Seamus Christopher Fernandez: Okay, great. I'll jump back in the queue out of respect for the other analysts on the call. Your next question will come from the line of Yasmeen Rahimi with Piper Sinler.

And so I think that the amount of weight loss, we're seeing we're clearly by itself independent of any specific look at liver fat.

Based on the studies, we know with let's say, 10% weight loss, but that's over a long period of time some of them could be achieving much sooner than that but that should project to a beneficial effect and Nash.

Yasmeen Rahimi: Hi team, thank you so much for taking my questions and thank you for the updates. A few for you: maybe a good place to start would be just providing us with some color on the sides, on how many patients per cohort we should be seeing data. I went back to your corporate deck, and you know, it refers to the obesity study being 100 patients. You nicely showed the patient per patient weight loss in the 108, 1.8 milligram, which is nine patients.

Great and then just on the preclinical docks would debt is going on particularly for the debt.

And the two more visible and <unk> and then maybe for the oral <unk> one.

Could you just comment on.

And what might be the requirements here that are different and towards Nash versus obesity, and sorry, if I missed that and the distillate to the chronic tox data.

Alex.

And that goes into it and then maybe just comment on what might be the IND timelines for the <unk>.

Yasmeen Rahimi: and Foreign Placebo.

So there are two questions. There the first would be that the talks that we're doing right now will enable both the Nash program and the national and and the obesity and.

Scott Harris: So as we head into September, can you draw, can you provide a color for me? How many patients are on placebo? How many are within each of the three-dose cohorts? That could be very helpful. And then I have two follow-ups for you. Right. Hey, Yasmeen, good morning.

Okay actually the obesity and Nash R&D will be followed before the Tox work base from the prior Tox work.

And the chronic Tox study will specifically enable the longer term national obesity trials, but it will enable both in terms of the IMD for the oral formulation, we havent been public and obviously, we're doing studies right now to look at that and.

Scott Harris: So we are enrolling 10 to 15 per cohort, and the randomization ratio between those who receive Alt-801 and those who receive placebo is 4 to 1. So it obviously varies a bit between cohorts, but that would be the general advice that we would give. Okay, another question for you is, you know, around expectations and weight loss going into week 12. So when we look at historical data comparing weight loss with an overweight population that is non-diabetic, you see, the magnitude is twofold.

Once we have a specific guidance and when we would be able to fall and <unk> will let you know.

Yes.

Too early to project in terms of when we might be going into an IND on <unk>, we hope to update everybody towards the end of the year in terms of our progress with the oral and all.

And then based on that we'll figure out what would be the timeline for filing an IND and update folks accordingly.

Great and then just do.

And the higher level of vision here for the program.

You have any early thoughts on it.

Given everything you're doing on this next year and at some point.

What you may want to do internally versus what maybe effort by an external partner and any because you do have different indication and the different formulations of.

Scott Harris: So I guess, you know, why can we not make the assumption, maybe I'm wrong, you're getting 6% at week six; should you be getting at least over 10% at week 12? And the significance of that, like, is there a chance that that might not fall in and that there is not a linear relationship between week six and week 12? So if you could just comment on that, that would be great.

And while this is going to require a ton of capital and realize the maximum value is any early thoughts and what was maybe relatively more attractive to you.

Yes, so that's a good good question Max obviously, the first thing first we need to generate all of the data that we are talking about we are well funded in terms of reaching all of these milestones and that data will really guide US should we proceed with obesity ahead of Nash, but instead of some and that.

Question will address right now.

We think there is value in both of these indications. So thats, what we are pursuing them and pattern lateral and generating all of that data because that would be important for anybody.

Yasmeen Rahimi: That would be helpful.

To be able to value of this program and make that determination as to do we go after both of these indications do we go after one before the other so that's really the focus right now but over time as the data becomes available, we'll certainly be able to to make it a call in terms of niche indications we pursue ahead.

Scott Harris: Right, so I think the most important thing is that, to the eye, the trends are continuing. If we focus on specific numbers, especially small numbers, we may not really get the right impression. So I think the most important thing is that visually, when you look at the data, you're convinced that it's linear, that it's continuing, and that we don't actually cite a specific number. And we think that that will be the right approach. I just don't want us to get hung up on a decimal place for success. Thank you.

The other.

Great. Thanks for taking our questions.

Your next question comes from the line of John <unk> with JMP Securities.

Hey, good morning, and thanks for taking the questions. Just a couple from me when we think about the 12 week read out and the new Biomarkers will be getting and I was hoping you could provide some color on which will be particularly informative and that could give more differentiation from Ada one versus the other <unk> candidates and we've seen.

Hey, John This is Scott again, thanks for joining the call. This morning.

Yasmeen Rahimi: And then can you comment on, as of right now, if any, what your discontinuation rates have been? I know that when you reported six weeks' data, there was one patient that discontinued. Are you able to comment on, sort of, the discontinuation rate as of right now? Yeah, we haven't been public on that, Yasmeen.

No.

I think that all of the.

Readouts will be informative.

Recognize there based on small numbers of subjects.

So.

Based on the amount of variability we've seen within each of the measurements.

B.

Higher or lower contributory to the overall program.

I think the things that we want to understand.

And the Readouts as glucose homeostasis at this point more for safety then for efficacy we want to make sure that were not being.

Scott Harris: We obviously will with the 12-week data. Okay, and then I just want to understand, maybe... [inaudible] At what point are you so that you're on track as soon as IND is clear to kick off the 52-week data? It's maybe a little unclear to me.

And being disruptive to glucose metabolism.

Obviously, if we see a beneficial effect will be very helpful. We've already talked about the fact that the best way to control diabetes over the long term is to lose weight. So we're optimistic that over the course of a year that we're going to have better control of diabetes, regardless of what we see and the beginning but I would emphasize that we haven't seen any.

Vipin Garg: Yeah, so let's go through the timeline quickly. The IND for NASH will be filed soon. As Scott mentioned during his presentation, we have completed, obviously, talks up to 13 weeks. That enables us to do 12 weeks of dosing. And we are in the process of completing the chronic RAT and SINO talks that will enable a long-term NASH study. So that will be completed later this year, well in advance. That talk study will be completed later this year, well in advance of either a 52-week NASH trial or a long-term obesity trial. So there's a comfortable timeline there that we feel comfortable about hitting.

Any evidence of any loss of glucose control and the healthy volunteers were studying right now mechanistically, we will look at insulin resistance that'll help us understand the changes and or the glucose homeostasis that we're seeing.

And we'll also get some mechanistic information that will help us look at the relative balance.

Of the <unk>, one versus glucagon effects and I think those are going to have to be interpreted rather than necessarily driving specific messaging.

Calorie intake should track with the GOP, one component of the molecule, whereas resting energy expenditure and ketone bodies, let's say would track with the glucagon component and there'll be some other things and we'll look at such as inflammatory markers.

Well, so I think all and all of them will probably gives us a much better feel for the compound.

Yasmeen Rahimi: Okay, thank you. I'll jump into the queue. Thanks.

But what we're emphasizing here is the primary.

Readout of importance is going to be the weight loss and I.

Kalichi Chikara: Your next question will come from the line of Kalichi Chikara.

I think thats whats really driving how we're going to apply the molecule, how we envision and the molecule and how we design studies and the future.

Kalichi Chikara: Good morning and thank you. I have just two questions on my end.

Got it and.

For the diabetic study I know historically, we see differential weight loss responses and diabetic versus not and to bet on that.

Kalichi Chikara: I guess based on the current preclinical and clinical data, is it your expectation that you would use the same dose in both NASH and obesity? Just trying to get a sense of that given that the glucagon component of 801 has beneficial effects on the liver. So just trying to determine there what the dose could potentially be. White.

Do you have any sense on what degree you might see a difference there but is going to be in line with what we've seen historically or there might be some.

Differential response based on <unk> hundred ones activity or <unk>.

Relative <unk> one glucagon.

Mississippi.

And that's a great question historically, if you take all of the compounds and I'm talking about <unk> <unk> and.

And to some extent qatada tied although it's really a GOP one with a little glucagon typically seeing about 60% of the weight loss and diabetics that you would see and non diabetics.

Scott Harris: Right, so the initial answer to that question, Kalechi, would be yes, we do expect the doses to be similar, but you brought up a good point that glucagon has independent effects over weight loss, so potentially the dose in NASH could be lower, but recognize that when you're treating NASH, you're not just treating the liver, you're treating the whole patient, so that we would think that we would try to administer doses to NASH patients that would not only achieve optimal fat reduction in the liver, but also optimal weight loss because of the non-hepatic comorbidities.

That would apply to those compounds, which are predominantly GOP one base.

Would that translate to the weight loss, and we would see and diabetics with our molecule. We don't know it's a different molecule.

Somewhat unique and.

It's not only.

<unk>, one glucagon coagulant its one to one so I think that.

In terms of general description, yes based on the literature, you would expect to see less weight loss and diabetics, but we have a different compound and we're just going to have to see what we see.

And diabetics and weather.

Whether we get better weight loss and the other compounds.

That had previously been studied and diabetics.

And one more if I may just on timing of data the 12 week phase <unk> and Apple patients.

Kalichi Chikara: Got it. Thank you. That's very helpful. And I guess my second question, big picture, is I wanted to get your latest thoughts on the development and potential commercialization of 801 and these two large indications, particularly as it relates to partnering. Is that a possibility? Are you having those discussions right now? And based on those discussions, if you're having them, do you have a sense of the type of data the data partners are hoping to see?

And you want to see that data before starting the 52 week biopsy for any kind of information for design or inclusion criteria or.

And when does that day theyre going to come relative to the start of a 52 week study.

We will have that data before the start of the 52 week study, whether we wait for the full readout of 12 weeks or do an interim analysis to drive the decision, making will have to make that decision, but right now.

<unk>.

We could wait for that data and we could take and interim cuts and look at the data.

Got it thanks for the color.

Yes.

At this time there are no further questions do you have any closing remarks.

Yes, thank you everyone for participating today.

And we appreciate the opportunity to share our results and outlook with you and thank you for your continued interest have a nice day.

Vipin Garg: Hey, Kalaichi, this is Vipin. Yeah, so in terms of thinking long term strategically, as you can see, the kind of trials that we're designing, our goal is to answer as many critical questions as possible. And the idea really is to build significant value in this asset quickly. You know, at this point, we just have phase one data from six weeks, so obviously, 12-week data is important.

Ladies and gentlemen, thank you for participating you may now disconnect.

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Vipin Garg: But then we've designed a number of studies that will answer some critical questions. We do know, one thing we do know is that there is significant interest in assets like this from large players and strategic partners. I can name a dozen companies that would be interested in this. So, at this point, we're keeping all our options open. We are in a good position to execute on this plan, so we've got a lot of options, and we will continue to monitor the situation.

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Vipin Garg: Our goal is to increase the value of this asset over the next 12 months, let's say 12 to 18 months, and as more data becomes available, we are, you know, there is no doubt that they would be interested in an asset like this from multiple players.

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Kalichi Chikara: Got it, got it. That's very helpful. Thank you.

Mayama: Your next question will come from the line of Mayama, with B-Rally Securities.

Mayama: Thank you. Good morning, team. Thanks for taking our question. I appreciate the resilience and data-driven approach to advancing your pipeline. So, just quickly on the ALT801 program, could you maybe just comment on whether the six-week – was there a built-in look for the six-week 2.4 MCDOS level, or you're just going out to the 12-week there?

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Mayama: There was no interim analysis then.

Scott Harris: Right, Kolechi, there was no interm... Mike. Oh, I'm sorry, Mayank. Mayank, there was no interim analysis on the six-week interim analysis of the 2.4 milligram dose.

Mayama: I understood. And then on the, you know, trying to understand the expectation for the phase 2b, excuse me, the 12-week NASH study, what could we glean from these 12-week obese, non-diabetic patients, if anything, you know, given what their baseline LSC or liver enzymes might be? And should we be expecting, should we be looking to learn anything on liver fat, for example, from this 12-week readout in September?

Scott Harris: Right. So I'll start by saying that we think the results from this study will translate. Attributes translate in the semaglutide trials to very good results at long-term readout. We did not assess liver fat content in this trial, so I really can't comment on that. And because this is not a NASH population.

Scott Harris: I wouldn't expect that we would have enough baseline ALT elevations to see much of a signal or make much sense of anything that would predict results in NASH. I think that the amount of weight loss we're seeing will be clearly, by itself, independent of any specific look at liver fat. Based on the studies, we know with, let's say, 10% weight loss, but that's over a long period of time, something we could be achieving much sooner than that, and that should project to a beneficial effect in NASH.

Scott Harris: Great. And then just on the preclinical work that is going on, you know, particularly for the INDs, the two more visible INDs, and then maybe for the oral GLP-1, could you just comment on, you know, what might be the requirements here that are different for NASH versus obesity? I'm sorry if I missed that. Is it just related to the chronic talks, or is there something else that goes into it? And then maybe just comment on what might be the IND timelines for oral GLP-1.

Scott Harris: Yeah, so there are two questions there. The first would be that the talks that we're doing right now will enable both the NASH program, the NASH IND, and the obesity IND. Okay.

Scott Harris: Actually, obesity, and NASH I&D will be followed before the talks work based on the prior talks work. The chronic tox study will specifically enable the longer-term national obesity trials, but it will enable both. In terms of the IND for the oral formulation, we haven't been public about that. Obviously, we're doing studies right now to look at that, and once we have specific guidance and when we would be able to file an IND, we'll let you know.

Vipin Garg: Yeah, Mayank, this is too early to project in terms of when we might be going into an IND for oral. We hope to update everybody towards the end of the year in terms of our progress with oral ALT801, and then based on that, we'll figure out what the timeline would be for filing an IND and update folks accordingly.

Mayama: And Vipin, just on the higher-level vision here for the program, do you have any early thoughts on, given everything you'll learn about this next year at some point, what you may want to do internally versus what may be an effort by an external partner? Because you do have different indications, different formulations. Obviously, it's going to require a ton of capital to realize the maximum value here. Any early thoughts on what may be relatively more attractive to you?

Vipin Garg: Yeah, so that's a good question, Mayank. Obviously, first things first, we need to generate all the data that we are talking about. We are well-funded in terms of reaching all these milestones, and that data will really guide us as to whether we proceed with obesity ahead of NASH, for instance. I mean, that question we will address right now. We think there is value in both of these indications, so that's why we are pursuing them in parallel and generating all that data because that would be important for anybody to be able to value this program and make that determination as to whether or not we go after both of these indications.

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Vipin Garg: Do we go after one before the other? So that's really the focus right now, but over time, as the data becomes available, we'll certainly be able to make a call in terms of which indication we pursue ahead. Great. Thanks for taking our question.

Jonathan Patrick Wolleben: Your next question comes from the line of John Wolleben with JMP Security. Hey, good morning, and thanks for taking the questions. Just a couple from me.

Jonathan Patrick Wolleben: When we think about the 12-week readout and the new biomarkers we'll be getting, I was hoping you could provide some color on which will be particularly informative and that could give more differentiation between 801 versus the other GLT-1 candidates. Hey, John, this is Scott again. Thanks for joining the call this morning. You know, I think that all of the readouts will be informative. Recognize they're based on small numbers of subjects. So, you know, based on the amount of variability we've seen within each of the measurements, they'll be a higher or lower contributor to the overall program.

Jonathan Patrick Wolleben: You know, I think the things that we want to understand based on the readouts are: glucose homeostasis is at this point more about safety than efficacy. We want to make sure that we're not being disruptive to glucose metabolism. Obviously, if we see a beneficial effect, it will be very helpful. We've already talked about the fact that the best way to control diabetes over the long term is to lose weight. So we're optimistic that over the course of a year, we're going to have better control of diabetes regardless of what we see in the beginning.

Jonathan Patrick Wolleben: But I would emphasize that we haven't seen any evidence of any loss of glucose control in the healthy volunteers we're studying right now. Mechanistically, we'll look at insulin resistance, which will help us understand the changes in or the glucose homeostasis that we're seeing, and we'll also get some mechanistic information that will help us look at the relative balance of the GLP-1 versus glucagon effects. And I think those are going to have to be interpreted rather than necessarily driving specific messaging.

Jonathan Patrick Wolleben: You know, calorie intake should track with the GLP-1 component of the molecule, whereas resting energy expenditure in ketone bodies, let's say, would track with the glucagon component. And there'll be some other things that we'll look at, such as inflammatory markers as well. So I think, all in all, all of them will probably give us a much better feel for the compound. But what we're emphasizing here is that the primary readout of importance is going to be weight loss.

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Jonathan Patrick Wolleben: I think that's what's really driving how we're going to apply the molecule, how we imagine the molecule, and how we design studies in the future. Got it. And for the diabetics study, I know historically we see differential weight loss responses.

Scott Harris: Diabetics vs. Non-Diabetics, do you have any sense of to what degree you might see a difference there, if it's going to be in line with what we've seen historically, or there might be some differential response based on 801's activity or relative GLP-1 glucagon specificity?

Scott Harris: Yeah, that's a great question. Now, historically, if you take all the compounds I'm talking about, zepatide, semaglutide, and to some extent, ketatatide, although it's really a GLP-1 with a little glucagon, typically see about... 60% of the weight loss in diabetics that you would see in non-diabetics. That would apply to those compounds that are predominantly GLP-1 based. But would that translate to the weight loss that we would see in diabetics with our molecule? We don't know for sure.

Scott Harris: It's a different molecule. It's somewhat unique in that it's not only a GLP-1 glucagon coagulant, but it's one-to-one. So I think that in terms of a general description, yes. Based on the literature, you'd expect to see less weight loss in diabetics, but we have a different compound. We're just going to have to see what we see in diabetics and whether we get better weight loss than the other compounds that have previously been studied in diabetics.

Jonathan Patrick Wolleben: And one more, if I may, just on the timing of the...

Jonathan Patrick Wolleben: The 12-week Phase 1b and NAPLD page

Scott Harris: Do you want to see that data before starting the 52-week biopsy for any kind of information on design or inclusion criteria, or when is that data going to come relative to the start of the 52-week study? Yeah, we'll have that data before the start of the 52-week study. Whether we wait for the full readout at 12 weeks or do an interim analysis to drive the decision making, we'll have to make that decision. But right now, you know, we could wait for that data, or we could take an interim step to look at the data.

Jonathan Patrick Wolleben: Got it. Thanks for the color. Yeah.

Operator: At this time, there are no further questions. Do you have any closing remarks?

Vipin Garg: Yes. Thank you everyone for participating today. We appreciate the opportunity to share our results and outlook with you and thank you for your continued interest. Have a nice day. Ladies and gentlemen, thank you for participating. You may now disconnect.

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