Q3 2021 Arcturus Therapeutics Holdings Inc Earnings Call

[music].

Operator: Greetings and welcome to our Tourist Therapeutics third quarter 2021 earnings 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 assistance,

Greetings and welcome to our tourist Therapeutics third quarter 2021 earnings call. At this time, all participants are in a listen only mode.

Question and answer session will follow the formal presentation, if anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.

Operator: require operator assistance during a conference, please press Star Zero on your telephone keypad. As a reminder, this conference is being recorded.

As a reminder, this conference is being recorded it is now my pleasure to introduce your host you Park in a ROI senior director of Investor Relations. Thank you you may begin.

Operator: It is now my pleasure to introduce your host, Deepakena Roy, Senior Director of Inventus.

Deepakena Roy: Senior Director of Investor Relations. Thank you. You may begin.

Yeah.

Deepakena Roy: Thank you, Doug. Good afternoon, and welcome to Arcturis Therapeutics' third quarter 2021 financial results and corporate update call. Thank you all for joining us.

Thank you Doug good afternoon, and welcome to off to the Therapeutics third quarter 2021 financial results and corporate update call. Thank you all for joining US today's call will be led by Josephine President and CEO, Andy Sassine CFO departure of a cooler CSO and C O O and Steve Hughes.

Deepakena Roy: Today's call will be led by Joseph Fane, President and CEO, Andy Sassine, CFO, Dr. Pat Chivakula, CSO, and C.O., and Dr. Steve Hughes, our chief medical officer. Before we begin, I would like to remind everyone that statements made during this call regarding matters that are not historical facts are forward-looking statements within the safe harbor provisions of the Private Security Litigation Reform Act of 1995. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties, and assumptions that may cause actual results to differ from those expressed.

Our Chief Medical Officer.

Before we begin I would like to remind everyone that statements made during this call regarding matters that are not historical facts are forward looking statements within the safe Harbor provisions of the private Securities Litigation Reform Act of 1995.

Forward looking statements are not guarantees of performance they involve known and unknown risks uncertainties and assumptions that may cause actual results performance and achievements to differ materially from those expressed or implied by the statement. Please see the forward looking statement disclaimer on the company's press release issued earlier today.

Deepakena Roy: Performance and achievements may differ materially from those expressed or implied by the state. Please see the forward-looking statement disclaimer in the company's press release issued earlier today, as well as the risk factors section in our forms 10Q and 10K filed with the SEC. In addition, any forward-looking statements represent our views only as of the date such statements are made, November 8, 2021. And our tourist company specifically disclaims any obligation to update such statements to reflect future information, events, or circumstances.

As well as the risk factors section in our forms 10-Q, and 10-K filed with the SEC and.

In addition, any forward looking statements represent our views only as of the date such statements are made November eight 2021.

Arcturus, specifically disclaims any obligation to update such statements to reflect Fisher information events or circumstances with that I'll now turn the call over to Joe Joe.

Deepakena Roy: With that, I'll now turn the call over to Joe. Okay?

Joseph E. Payne: Hey, thank you to Pankar. Good afternoon to all.

Hey, Thank you did pay car.

Good afternoon to all and thank you for <unk>.

Joseph E. Payne: Thank you for joining our Taurus's third quarter quarterly call today. We are looking forward to telling you more about our recent progress, highlighted by the advancement of our ARCT-154 COVID vaccine profile. At Arcturus, we are developing differentiated MRNA-based vaccines and novel therapeutics. Since the inception of the company, we've been working to develop a differentiated platform technology, and we've also, more recently, advanced a number of highly promising pipeline candidates into clinical development.

Joining our Arcturus is third quarter quarterly call today, where we are looking forward to telling you more about our recent progress highlighted by the advancement of our <unk> 154, Covid vaccine program.

At our tourists we are developing differentiated mrna based vaccines and novel Therapeutics since the inception of the company we've been working to develop a differentiated platform technology and we've also more recently advanced a number of highly promising pipeline candidates into clinical development.

Joseph E. Payne: We believe that our approach to developing MRNA vaccines and therapeutics has the potential to directly address the underlying molecular basis of many serious diseases, and in doing so, we hope to provide transformative new medicines to patients living with many types of life-threatening conditions.

We believe that our approach developing mrna vaccines and therapeutics has the potential to directly address the underlying molecular basis of many serious diseases and in doing so we hope to provide transformative new medicines to patients living with many types of life threatening conditions.

Joseph E. Payne: We've made excellent progress advancing our MRN-based vaccines, and I'll begin with a discussion of our vaccine programs targeting COVID-19. So let's begin with ARCT 154. This is our vaccine candidate that targets the SARS-COV-2 variants of concern, including those that are currently widespread across the globe. ARCT 154 utilizes our self-transcribing and replicating RNA technology, or the STAR technology. This vaccine includes an optimized MRNA sequence along with multiple proprietary modifications to improve its stability and increase its translation.

We've made excellent progress advancing our mrna based vaccines and I'll begin with a discussion of our vaccine programs targeting COVID-19, So let's begin with our <unk> 154. This is our vaccine candidate that targets are the SAR C. O V. Two variance of concern, including those that are currently wide.

Spread across the globe.

Our C T $1 54 utilizes our self transcribing and replicating RNA or the star.

Technology.

This vaccine include includes an optimized mrna sequence along with multiple proprietary modifications to improve its stability and increase its translation. These.

Joseph E. Payne: These modifications, as well as the key rational optimizations performed, may improve the immunogenic profile of the expressed antigen, which in this case is the spike protein. I'll take a moment to identify some of the key differentiators for ARCT 154.

These modifications as well as the key rational optimizations performed may improve the immunogenic profile of the expressed antigen, which in this case is the spike protein.

I'll take a moment to identify some of the key differentiators for <unk>.

<unk> 54, firstly it was designed to require a low dose level, so only five micrograms per dose.

Joseph E. Payne: Firstly, it was designed to require a low dose level, so only 5 micagrams per dose. Secondly, it's been updated to target the currently widespread variance of concern. Third, it includes rational modifications to the antigen intended to improve immunogenicity, such as inactivating the furin cleach site. Also, it utilizes our proprietary lunar delivery technology, our lipid nanoparticle platform.

Secondly, it's been updated to target the currently widespread variance of concern.

Third it includes rational modifications to the antigen.

<unk> intended to improve immunogenicity, such as Inactivating, the fear in Cleveland site.

Also utilizes our proprietary Luna delivery technology, our lipid nanoparticle platform.

Joseph E. Payne: And finally, ARCT-154 utilizes a self-amplifying mechanism that's designed to extend the duration of antigen expression, and this platform has shown robust T-cell responses in multiple preclinical models. Well, we've previously disclosed ARCT 154 preclinical data demonstrating strong neutralizing immunogenicity in non-human primates to SARS, COV2, alpha, beta, gamma, and delta variants. The preclinical NHP data demonstrate that ARCT 154 elicits approximately 14 to 26-fold greater neutralizing antibody titers than ARCTO 21, our first generation COVID vaccine. In addition, we've observed robust T-cell responses to these various strains following administration of ARCT 154 and non-human primates. But shifting on to human clinical trials, we've been working closely with our collaborators in biotech to operationalize This study has the potential to lead to an EUA in Vietnam as early as the first quarter of 2022.

And finally, a RCT $1 54 utilizes a self amplifying mechanism. That's designed to extend the duration of antigen expression and this platform has shown robust T cell responses in multiple preclinical models.

Well, we've previously disclosed a R. C. T 154, preclinical data demonstrating strong neutralizing immune immunogenicity and nonhuman primates to SAR C. O V. Two alpha beta and gamma and Delta variance the preclinical NH P data demonstrate that <unk> $1 54 elicits approx.

<unk> 14 to 26 fold greater neutralizing antibody titers than a our CTO 'twenty one are first generation Covid vaccine candidate.

In addition, we've observed robust T cell responses to these various strains following administration of <unk> 54 in nonhuman primates.

But shifting on to human clinical trials, we've been working closely with our collaborators in biotech to operationalize a phase one slash two slash three study designed to efficiently and rapidly apply for an EUA or an emergency use authorization application in Vietnam and also <unk>.

Provide for a path to full approval in Vietnam. This study has the potential to lead to an EUA in Vietnam as early as the first quarter of 2022.

Joseph E. Payne: All phases of this trial are sponsored and funded by VinBiotech, and the randomized observer-blind study with both placebo-controlled and active-controlled cohorts that will assess the safety, immunogenicity, and efficacy of ARCT-154 against COVID-19. Well, I want to pause now and emphasize that we have had an efficient quarter progressing ARCT-154. It was just last August, August 2021, when we first announced the 100 participant phase one cohort and had commenced enrollment. Then the 300 participant phase two, and the 600 participant phase three cohorts initiated enrollment shortly thereafter.

All phases of this trial are sponsored and funded by the biotech and the randomized observer blind study with both placebo controlled and active controlled cohorts that will assess the safety immunogenicity and efficacy of <unk> 154 against COVID-19.

Well I want to pause now and emphasize that we have had an efficient quarter progressing a RCT $1 54.

It was just last August August 2021 when we first announced the 100 participant phase one cohort and had commenced enrollment.

Then the 300 participant phase two and the 600 participant phase III cohorts initiated enrollment shortly thereafter.

Joseph E. Payne: Then last month in October, we announced that the Phase 3B cohort had begun enrolling. The Vietnam Ministry of Health gave approval to advance into this large Phase 3B trial based upon its assessment of early safety data from the first 1,000 individuals dosed in the Phase 1 and 2 and 3A cohort. Well, I'm very pleased with the extraordinary effort of our team.

Then last month in October we announced that the phase three b cohort had begun enrolling at the Vietnam Ministry of Health gave approval to advance into this large phase III trial based upon its assessment of early safety data from the first 1000 individuals dosed in the phase one and two and three eight cohorts.

Well I'm very pleased with the extraordinary effort of our team.

Joseph E. Payne: And I'm excited to report today that enrollment in the ARCT 154 Phase 3B study is completed, and a Phase 3C sub-study is expected to meet target enrollment this week. This will bring us to a total of over 19,000 participants in the combined study.

And I'm excited to report today that enrollment of the E. R. C. T $1 54 phase III <unk> study is completed.

And our phase III C substance Starr sub study is expected to meet target enrollment. This week. This will bring us to a total of over 19000 participants and the combined study.

Joseph E. Payne: The Phase 1-2-3A cohorts have now completed two doses of ARCT 154, given 28 days apart. The Phase 3 trial has been amended. The size of the Phase 3B trial is now about 16,000 participants, and it also includes an immunogenicity non-inferiority sub-study of approximately 2,000 participants, which we call the Phase 3C cohort. The total size of Phase 3B and Phase 3C is anticipated to be around 18,500

The phase one slash two slash three eight cohorts have now completed two doses of <unk> $1 54, given to 28 days apart.

The phase III trial has been amended the size of the phase III B is now about 16000 participants and it also includes an immunogenicity non inferiority sub study of approximately 2000 participants, which we call the phase III C cohort the total size of phase III B and phase III.

<unk> is anticipated to be around 18500 participants.

Joseph E. Payne: This sub-study will evaluate the immunogenicity of ARCT 154 against AstraZeneca's COVID vaccine. The Phase 3B cohort has completed enrollment with over 16,000 participants, and the Phase 3C sub-study is expected to meet target enrollment this week. The safety and immunogenicity data from the Phase 1, 2 and 3A cohorts have the potential to form the basis for filing an EUA or emergency use authorization application in Vietnam in December. The immunogenicity non-inferiority data from Phase 3C, together with the safety and efficacy data from the other phases of the trial, are designed to form the basis of filing for potential full approval in Vietnam in the second half of 2020. Dr. Steve Hughes, our CMO, our chief medical officer, is going to provide more details later in today's call regarding the ARCT-154. I'll now move on to ARCTO21.

This sub study will evaluate immunogenicity non inferiority of <unk> 54 against Astrazeneca as Covid vaccine.

The phase III B cohort has completed enrollment with over 16000 participants in the phase III C. Sub study is expected to meet target enrollment this week.

The safety and Immunogenicity data from the phase one two and three a cohorts has the potential to form the basis for filing an EUA or emergency use authorization application in Vietnam in December.

The immunogenicity non inferiority data from phase III C together with the safety and efficacy data from the other phases of the trial are designed to form the basis of filing for potential full approval in Vietnam in the second half of 2022.

Dr. Steve Hughes, our CMO, our chief Medical officer, he's going to provide more details later in today's call regarding the hair CTO $1 54.

I'll now move on to a R. C. T O 21, a our CTO to one is a differentiated COVID-19 mrna vaccine candidate and this was our first vaccine to enter the clinic and we've previously discussed that a single administration of a R. C. T. R. Oh, we shared this data that a single administration of <unk>, our CTO of <unk>.

Joseph E. Payne: ARCT O21 is a differentiated COVID-MRNA vaccine candidate, and this was our first vaccine to enter the clinic. And we'd previously discussed that a single administration of ARCT, or we shared this data, that a single administration of ARCTO 21 resulted in what we expect to be a meaningful humoral and T-cell response. We have an ongoing fully enrolled ARCTO 21 Phase 2 study, and we have previously discussed the encouraging preliminary tolerability and immunogenicity data from this study. Specifically, immunogenicity data from the study shows greater than 90% zero conversion for IgG antibodies binding to the full-link spike protein at day 28, following a single-shot dose of ARCTO-21.

One resulted in what we expect to be a meaningful moral and T. Cell response, we have an ongoing fully enrolled our CTO 21 phase two study and we have previously discussed the encouraging preliminary tolerability and Immunogenicity data from this study specifically immunogenicity data from the study shows greater than.

90% Seroconversion for I G. G antibodies binding to the full length Spike protein at day 28, following a single shot dose of our CTO 'twenty one.

Joseph E. Payne: As previously reported, ARCTO 21 has been selected by a global entity for inclusion in a phase three vaccine trial against COVID-19 and is sponsored and funded by the entity. At this time, per our agreement, we're unable to discuss further specifics. However, we are understandably very grateful for this group's support, which has been so valuable in the global fight against COVID-19. I'll now turn the time over to Dr. Steve. Thanks, Joe.

As previously reported our CTO 21 has been selected by a global entity for inclusion in the phase III vaccine trial against COVID-19, and is sponsored and funded by the entity.

At this time per our agreement, we're unable to discuss further specifics.

However, we are understandably very grateful for this group support which has been so valuable in the global fight against COVID-19.

I'll now turn the time over to Doctor Steve Hughes.

Thanks Jack.

Stephen L. Eck: I would like to begin with some additional details about the reasons for the changes to the ARCT-154 phase three study design mentioned by Joe. As many of you know, the COVID vaccine rollout in Vietnam has been very successful, with almost one third of the vaccine eligible population vaccinated. Consequently, it was no longer deemed ethical to maintain participants on placebo for a prolonged period of time.

I would like to begin with some additional details about the reasons for the changes to the I O C. T 154 phase III studies as Owen mentioned by Joe is.

As many of you know the Covid vaccine rollout in Vietnam has been very successful with it.

This was a vaccine eligible population.

Excellent.

Consequently, it was no longer deemed ethical for maintained participants ought to see both of them for a long period of time.

Stephen L. Eck: In consultation with the Vietnam Ministry of Health and our collaborators at In Biotech, the Phase 3B, placebo-controlled period was therefore reduced to two months. Additionally, however, the Ministry of Health has now opened a path to approval based on immunogenicity non-inferiority comparison with vaccines that are already authorised in Vietnam. So our protocol amendment has also included a new cohort, phase three, in order to take advantage of this additional potential path to full approval for ARCT-154.

In consultation with the Vietnam Ministry of Health and all collaborators has been biotech the phase III. The placebo controlled period was therefore reduced to two months.

Additionally, however, the Ministry of Health has now opened a path to approval based on Immunogenicity and non inferiority comparison with vaccines that are already authorized in Vietnam fell a protocol Amendment is also included a new cohort phase three in order to take advantage of this additional potential path for approval for a S E T.

A $1 54.

Stephen L. Eck: The phase 3C sub-study will obtain comparative immunogenicity data for ARCT-154 against AstraZeneca COVID-19 vaccine. This comparator was chosen because there is already immunogenicity data in the Vietnamese population for AstraZeneca COVID-19 vaccine using the same assays as we are using in the phase three study. And also because this vaccine could be made available by the Vietnam Ministry of Health within an expedited time. Amending the protocol in this way also adds valuable comparative data to inform potential prescribers of ARCT 154.

Tracy sub study will obtain comparative immunogenicity data for <unk> 154 against Astrazeneca COVID-19 vaccine.

This comparator was chosen because it's already immunogenicity data in the Vietnamese population for Astrazeneca COVID-19 vaccine using the same assays as we are using in the phase III study and also because this vaccine could be made available by the Vietnam Ministry of health within an expedited timeframe.

Amending the protocol in this way also adds valuable comparative data to inform potential prescribers of <unk> C. T 154.

Okay.

Stephen L. Eck: In addition to the trial of ARCT 154 in Vietnam, we also gained approval from the Singapore Health Sciences Authority and the US FDA to enroll a phase one-two study with two of our next generation vaccines, ARCT 154 and ARCT 165, together with ARCT 021, administered as both a primary vaccination series and as a booster following initial vaccination with comina, I'm pleased to report that the Comerity Booster cohort for this study is now fully enrolled, while the other cohort in the study continues to involve vaccine naive part I will turn now to ARCT 810, our therapeutic candidate for or or or NACABAN transcarbanamilase or OTCD, This is a rare and serious disease with no approved treatments that address the root cause Our therapeutic candidate aims to restore expression of the normal ornathine transcarbamalase enzyme in the liver of patients with, This has the potential to restore your ear cycle activity, preventing neurological damage and the need for liver transplant, previously completed a phase one healthy volunteer dose escalation study with ARCT 810 that demonstrated that administration of ARCT 810 was associated with favorable tolerability and an attractive pharmacokanetic profile up to the top dose of 0.4 milligrams per gallon. This dose is within the anticipated therapeutic range that we have estimated based upon our preclinical, We have obtained approval from the UK Health Research Authority to initiate a phase two multiple dose clinical trials for ARCT 810, and we are currently recruited, The ARCT 810 Phase 2 study is a randomized, double-blind, placebo-controlled, nested, single, and multiple-lacending dose design that includes both adolescents and adults with OECD, study is designed to involve 24 adolescents adults in multiple countries in Europe and we anticipate that enrollment will commence in Q1 2020. The study is currently under review by multiple other EU regulators, so we anticipate approval to proceed at additional countries very much.

In addition to that they try to buy a C. T 154 in Vietnam. We also gained approval from the Singapore Health Sciences Authority and the U S. F D. A to enroll a phase one two study with two of our next generation vaccines I O C. T 154, and <unk> 65, together with I O C T zero to one.

<unk> administered as both a preliminary vaccination series and as a booster following initial vaccination with come on let's say.

I'm pleased to report that the commodity booster cohort for this study is now fully involved.

Other cohort in the study continues to enroll vaccine naive participants.

I'll turn now to I O C. T I turn off therapeutic candidate for ornithine, <unk> Kop and analyze or OTC deficiency. This is a rare and serious disease with no approved treatments to address the root cause of the disease.

Therapeutic candidate aims to restore expression of the normal one of the main trends called analyzed enzyme.

Patients with OTC deficiency. This has the potential to restore UAS oracle activity, preventing neurological damage and the need for liver transplantation.

We previously completed a phase one healthy volunteer dose escalation study with I O C. T. I turn that demonstrated that administration of I O C. D. E 10 was associated with favorable tolerability and an attractive pharmacokinetic profile up to the top dose of 0.4 milligrams per kilogram this dose.

Within the anticipated therapeutic range that we have estimated based upon a cleanup preclinical studies.

We have obtained approval from the U K Health Research authority to initiate a phase two multiple dose clinical trial for a S. E. T. A 10 and we are currently recruiting sites.

<unk> phase two study is a randomized double blind placebo controlled nested single and multiple ascending dose design that includes both adolescents and adults with SBC efficiency.

The study is designed to enroll 20 for adolescents adults in multiple countries in Europe, and we anticipate that enrollment will commence in Q1 2020.

Study is currently under the beautiful multiple other EU regulators said they anticipate approval to proceed as additional countries very soon.

Stephen L. Eck: Our other study, the Phase 1-2 Single Dose Study of patients in the United States, remains ongoing. We have a number of additional centers open there and continue to screen additional participants for Moving briefly now to our cystic fibrosis program. We have continued to progress the necessary preclinical studies to enable ARCT 032, our MNA therapeutic candidate for cystic fibrosis, to move into clinical studies, and we anticipate the submission of a clinical trial application for ARCT 032 in the first half of the year. Our flu vaccine program also continues to make good progress, studies, and we anticipate advancing our flu vaccine in the second half. Current flu vaccines typically have relative effectiveness, and we believe that this Thank you, Steve, and good afternoon, everyone.

All other study the phase one or two single dose study of <unk>.

T C patients in the United States remains ongoing we have a number of additional centers open and continue to screen additional participants with element.

Moving briefly now to our cystic fibrosis program, we have continued to progress the necessary preclinical studies to enable the ALC team.

Two mrna therapeutic candidate for cystic fibrosis to move into clinical studies, and we are at and we.

The submission of a clinical trial application for ALC team.

In the first half of 2022.

Our flu vaccine program also continues to make good progress in preclinical studies and we anticipate advancing our flu vaccine into the clinic in the second half of 2022 current flu vaccines typically have relatively full efficacy and we believe that this can be improved upon without mrna technologies. In addition, and I'll, let Andy nice vaccines have there.

I wanted you to being able to be rapidly adapted to talk a circulating flu strains or not possible.

Uh huh.

Thank you, Steve and good afternoon, everyone.

Andrew H. Sassine: The press release issued earlier today includes financial statements for the third quarter of fiscal year 21 and provides a summary and analysis of year over year sequential performance. Please refer to our 10Q for more details on the financial performance. Today, I will go over our financials and present some operating metrics as we continue to transition to a later stage clinical company with multiple programs in our pipeline. I will also provide some details regarding our manufacturing strategy as we prepare for the potential of emergency use authorization in Vietnam.

The press release issued earlier today includes financial statement for the third quarter of fiscal year 'twenty one.

And provides a summary and analysis of a year over year and sequential performance.

Please reference our 10-Q for more details on the financial performance.

Today I will go over our financials and presents some operating metrics as we continue to transition to a later stage clinical company with multiple programs in our pipeline.

I will also provide some detail regarding our manufacturing strategy.

Prepare for the potential of emergency use authorization in Vietnam.

Andrew H. Sassine: Finally, I will provide some insights regarding our cash position and expected run rate. As you heard Joe mention, we have had a very productive quarter and have had significant developments in our ARCT 154 program. ARCT 154 is our next generation vaccine candidate that we have partnered with biotech, who is sponsoring and funding our studies targeting the COVID-19 and variance of concern. VINBiotech is a part of the VIN group, one of Vietnam's largest corporations, and this partnering arrangement has resulted in significant savings of well over $200 million in clinical trial and manufacturing expenses.

Finally, I will provide some insights regarding our cash position.

The expected run rate.

And you heard Joe mentioned, we've had a very productive quarter and Ive had significant development in our a R. C. T 154 program.

You always see T 154 is our next generation vaccine candidate that we have partnered with them biotech who is sponsoring and funding our studies targeting the COVID-19 and variance of concern.

When biotech as a part of the <unk> group one of Vietnam as largest corporation in this partnering arrangement.

And significant savings of well over $200 million in clinical trial and manufacturing expenses.

Andrew H. Sassine: Our manufacturing strategy and diversification continues to be supported by our partnerships across the globe. The facility bailout, in partnership with the VIN Group in Vietnam, which can potentially produce up to 200 million doses per year, remains on track to begin production next year. As mentioned in our last call, we now have manufacturing partnerships in Asia, Europe, and the USA for the drug substance, drug product, lyophilization, and fill-finished production.

Our manufacturing strategy and diversification continues to be supported by our partnerships across the globe.

The facility Buildout in partnership with the <unk> group in Vietnam can potentially produce up to 200 million doses per year remains on track to begin production next year.

As mentioned in our last call. We now have manufacturing partnerships in Asia, Europe, and the USA for the drug substance drug product optimization and fill finish production.

Andrew H. Sassine: We continue to plan for the potential that one or more of our vaccines could receive emergency use authorization, and we expect to have the capacity to produce hundreds of millions of vaccine doses. I want to provide some color on our quarterly expenditures and forecasted cash runways. Our total recurring operating expenses averaged about $55 million in each of the first three quarters of fiscal year 21, with approximately $11 million attributed to GNA and is expected to increase nominally in the fourth quarter.

We continue to plan for the potential that one or more of our vaccines could receive emergency use authorization and we expect to have the capacity to produce hundreds of millions of vaccine doses.

I wanted to provide some color on our quarterly expenditures and forecasted cash runway.

Our total recurring operating expenses averaged about $55 million in each of the first three quarters of <unk>.

Fiscal year 'twenty one.

Approximately $11 million is attributed to G&A and is expected to increase nominally in the fourth quarter.

Andrew H. Sassine: The remaining approximately 45 million in R&D expenses relate to our current pipeline supporting our COVID vaccine candidates, OTC, cystic fibrosis, and lunar flu, and other programs, including stockpiling long-lead-time raw materials and vaccines for potential EUA. This amount is expected to increase in the next two quarters as we continue to build pre-launch inventory of ARCT 154 vaccines. The cash balance at the end of the third quarter was $414 million.

The remaining approximately $45 million and R&D expenses.

Two our current pipeline supporting our Covid vaccine candidate OTC, cystic fibrosis, and Luna flu and other programs.

Including stockpiling long lead time, raw material and vaccine for potential EUA.

This amount is expected to increase in the next two quarters.

We continue to build prelaunch inventory, a b or C. T $1 50 for a vaccine.

Our cash balance at the end of the third quarter with $414 million.

Joseph E. Payne: Based on our current pipeline, the company's cash position is expected to be sufficient to support operations for two years. I will now pass the call back to Joe. Hey, thanks, Andy. So, as we have heard, here at Arcturus, we've continued to make substantial progress advancing our MRN-based vaccine and therapeutic platforms. Thank you all for your time today and for your interest in Arcturis. We look forward to keeping you informed of our progress, no doubt. At this point, we can now go ahead and open the line for questions. Operators, or Operator, please proceed.

Based on our current pipeline company's cash position is expected to be sufficient to support operations for two years.

Now pass the call back to Joe.

Thanks, Andy So as we have heard.

Here at Arcturus, we've continued to make substantial progress advancing our mrna based vaccine and therapeutic platforms. Thank you all for your time today and for your interest in Arcturus, we look forward to keeping you informed of our progress no doubt at this point. We can now go ahead and open the line for questions operators.

Operator. Please proceed.

Operator: Thank you. Ladies and gentlemen, at this time, we will be conducting a question and answer session. If you'd like to ask a question, you may press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question Q. You may press star 2 if you would like to remove your question from the Q; for participants using speaker equipment, it may be necessary to pick up your handset before

Thank you ladies and gentlemen at this time, we will be conducting a question and answer session. If you'd like to ask a question you May 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 would like to remove your question from the Q4.

For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star gate.

Operator: your handset before pressing the start button. Our first question comes from the line of Yasmin Rahim with Piper Sandler. Please proceed with your question.

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

Yasmeen Rahimi: Thank you, team, and congratulations on some really remarkable accomplishment of enrolling, you know, the 16,000 patients into phase three. So maybe the first question for you would be to provide us with some color on that. Do you think that enough events will have occurred by December when you file for emergency authorization? What is the bar for being granted emergency authorization in Vietnam, if you could provide? Some color around that, and then I have a follow-up question for you, Joe.

Thank you team and congratulations on a really remarkable accomplishment.

You know that 16000 T sand and so the phase three so maybe the first question for you would be to provide us some color on do you think that and no events have occurred by December when you file for an emergency authorization.

What is the bar for to be granted emergency authorization in Vietnam.

Could provide some color around that and then I have a follow up question for you Joe.

Joseph E. Payne: Sure, thanks, Yaz, for joining the call. I'll pass that question on to Steve. Hi, Edmine. So, thank you for the question.

Sure. Thanks, He has for joining the call pass that question on to Steve.

Hi.

So thank you for the question actually the emergency use authorization.

Stephen L. Eck: Actually, the emergency use authorization doesn't.

Stephen L. Eck: doesn't require COVID events for approval in Vietnam. So we're anticipating that the EUA is going to be based upon immunogenicity data provided from the first 1,000 participants, together with safety data from those 1,000 participants and also from the 16,000 participants in the Phase 3B part of the study. The events will form part of the filing for a full approval subsequently. And for that full approval, we actually have two shots on goal, the event rate and also the immunogenicity non-inferiority compared with the AstraZeneca COVID-19 vaccine.

It doesn't require a.

Covid events.

The approval in Vietnam. So we are anticipating that would be a way is gonna be based upon immunogenicity data provided from the first 1000 participants together with safety data from those 1000 participants and also from the 16000 participants in the phase III B part of the study.

The.

Events will form part of the filing for full approval subsequently.

And for that full approval, we actually have two shots on goal.

The event rate and also the immunogenicity non inferiority compared with the Astrazeneca COVID-19 vaccine.

Stephen L. Eck: Thank you, team. And then maybe a question that we get quite frequently from clients is when we should be expecting the immunogenicity data. If you could provide some commentary and sort of the state cadence of the milestones between now and emergency authorization, that would be really helpful. And thank you for taking my questions. Sure.

Yes.

Thank you team and then maybe a question that we got quite frequently from clients are one we should be expecting the immunogenicity data you could provide some commentary sort of the cadence of the milestones between now and emergency authorization.

I think that would be really helpful.

And thank you for taking my question.

Sure.

Joseph E. Payne: Sure, yeah, with respect to data timing, I think it's understood that we are partnered with Vin Biotech, and we're also working closely with the Vietnam Ministry of Health, so they will obviously have first access to the data. And because Vin Biotech is sponsoring and funding the trial, we'll be working with them with respect to the data disclosure process. So it's challenging, as you can understand, to give guidance or specific guidance as to the timing of that data. But no doubt there will be data included in the emergency use approval application process. And we wouldn't be going through this if we didn't deem it or consider it favorable.

Yeah with respect to data timing I think it's understood that we had.

This program is partnered with within biotech and it's also we're working closely with the Vietnam Ministry of health. So they will obviously have first access to the data and because of in biotech is sponsoring and funding the trial will be working with them with respect to the disclosure process of the data. So it is challenging as you can understand to give guy.

And sort of specific guidance as to the timing of that data.

But no no doubt there'll be data included an emergency use approval application process.

And we wouldn't be going through this if we didn't deem it or consider a favorable data.

Okay.

Yasmeen Rahimi: Thanks, I'll jump in the back of the queue for letting my colleagues ask questions.

Thanks, and I'll jump back in the queue right I think my colleague that question.

Operator: Her next question comes from the line of Nick Abbott with Wells Fargo.

Okay. Thanks, guys.

Our next question comes from the line of Nick <unk> with Wells Fargo. Please proceed with your question.

Nick Abbott: with Wells Fargo. Please proceed with your questions.

Hello, Thanks, taking my question and yeah.

Nick Abbott: Hello, thanks for my question, and yes. Congratulations to you and your partners in Vietnam for some pretty heavy lifting here. The first question is, did I hear you say that a third of the population has been vaccinated in Vietnam? Yeah, so the statistics that were in the public domain as of November the 4th were around 26 million people in Vietnam had been vaccinated. And obviously, the eligible ones are the adults and the adolescents. So the younger children, at this point, have been vaccinated. So it's going to be around a third or more that is roughly thereabout.

Congratulations to you and your partners in Vietnam.

Some pretty heavy lifting here.

First question is how do they did he say that third of the population had been vaccinated in Vietnam.

Yes.

The statistics that we are in the public domain as of November the fourth was around $26 million.

People in Vietnam has been vaccinated and obviously the eligible ones of the adults and adolescence.

So the younger children at this point all vaccinated, so there's going to be around a third or more that are bad.

Stephen L. Eck: That's, oh, I see.

Yeah.

Stephen L. Eck: Oh, I see. So that 26 million represents a third or more.

Oh, I see so that $26 million represents a third of them all.

Stephen L. Eck: Yeah, so the population of Vietnam is around 100 million, but the 26 million, obviously that 100 million isn't all adults; it's a wide range of ages. So we're estimating that it's currently around about a third or thereabouts that are fully vaccinated as of November 4th. And so given the rate of vaccination, what proportion do you expect to be vaccinated at the time your vaccine is approved? And then how many doses do you expect to have stockpiled illegally? Maybe I can deal with the first part of that, and then I'll pass it over to Joe or Padd for the second part.

Yeah. So the population of Vietnam, as a matter of hundred $100 million, but the $26 million, obviously that $100 million isn't all that out it's a wide range of ages.

And so we are estimating that that is currently around about a third or thereabouts that are fully vaccinated.

As of November four.

And so given the rates of vaccination.

What proportion do you expect to be vaccinated and at the time you vaccine is approved and then how many doses do you expect to have stockpile that launch.

Maybe I can deal with the first part of that and then I'll pass over to Jabil path for the second part so.

Stephen L. Eck: So Vietnam is aggressively rolling out its vaccine campaign, but the ability to continue through and vaccinate all of the eligible population is going to be dependent upon those vaccines arriving. I don't believe that they have all of the vaccines sitting in a warehouse somewhere to vaccinate their entire population. So they're dependent upon vaccines coming in that have been promised by other entities and other companies.

When is aggressively rolling out as vaccine campaign, but.

The ability to continue through and vaccinate all of the.

Eligible population is going to be dependent upon how these vaccines evolving I don't believe that they have the vaccine sitting in a warehouse somewhere to vaccinate their entire population so that dependent upon vaccines coming in that had been promised by other entities and other companies.

Stephen L. Eck: And so far, those promises are sufficient to vaccinate a large majority of their population. But as I said, the rollout of the vaccine campaign is dependent upon those vaccines arriving in a timely fashion. I believe that the Vietnamese government has said it's targeting having everybody vaccinated by the end of the first quarter next year. But it remains to be seen whether they actually achieve that.

And so far those promises are sufficient to vaccinate, a large majority of that population because I've said it the rollout of the vaccine campaign is dependent upon those vaccines are evolving in a timely fashion.

I believe that the Vietnamese government has said it is targeting having everybody vaccinated by the end of the first quarter next year. So it remains to be seen whether they actually achieved that and we would be anticipating.

Andrew H. Sassine: And we would be anticipating an... emergency use authorization in the early part of next year, so ahead of that. And then, with respect to your manufacturing guidance, maybe Andy, you can speak to where we are with respect to stockpiles of ARCT 154. Yeah, we don't give specific guidance with respect to the quantity of the vaccine that we're producing, but we are obviously, you know, in discussion with not only the Vietnamese Ministry of Health but also other countries that are also looking to stockpile the vaccine for the ARC-154 for their variety of concerns. And then maybe, as a kind of follow-up to that,

An emergency use authorization and the early part of next year. So ahead of that.

And then with respect to your manufacturing guidance, maybe Andy you can speak to where we are with respect to stockpiling of <unk> $1 54.

Yeah, we don't give specific guidance with respect to the quantity of the vaccine that we're producing but we are obviously.

In discussions with the not only the Vietnamese Ministry of health, but also other countries.

That are also looking to stockpile the vaccine for the or $1 54 for the a variant of concern.

Okay.

And then maybe as a kind of follow up to that.

Nick Abbott: You know, I've asked in the past.

Boston the Pos data.

Nick Abbott: You know, an approval in Vietnam would be accepted in other countries or even by

An approval and in Vietnam would be accepted.

The countries or even by totally right shows so.

Nick Abbott: WHO, so you know, can you update us on where you are in the discussion?

Can you update us on where you are in discussion and.

Joseph E. Payne: discussion and how would this facility that's in Vietnam be supporting other countries, assuming, you know, in Asia, for example, what are the mechanics there of, you know, who sells that product in those other countries? Yeah, it's a great question. You know, clearly, we're establishing strong relationships with Vietnam and Singapore and the Southeast Asian part of the world, and how we expand from there is a key business strategic question. We've brought on Erdoche recently.

And how would this facility.

In Vietnam with that.

Supporting other countries.

You mean.

Asia for example, what are the mechanics there.

Who who sells that product in those other countries.

It's a great question, clearly, we're establishing strong relationships with Vietnam and Singapore in the Southeast Asian part of the World.

And how we expand.

From there it is.

As a key business strategic question, we've brought on their dose recently he leads our chief regulatory officer.

Joseph E. Payne: He leads our, he's our chief regulatory officer, a lot of experience at Merck internationally with vaccines, expansion and so he's helping guide in that effort but clearly there's an opportunity in Southeast Asia and it is unusual time still in that part of the area with respect to the pandemic so it's hard to draw on precedence for this but clearly there will be some level of appreciation for you know the the Vietnamese Ministry of Health with respect to ARC-154 in Southeast Asia and and we'll go from Thanks, too. And maybe just a last one for me on this, and that is

A lot of experience at work internationally with vaccine.

Expansion and so.

He is helping guide.

That effort, but clearly there's an opportunity in southeast Asia.

And it is an.

Unusual times still in that part of the area with respect to the pandemic. So it's hard to draw on precedence for this but clearly there'll be some level of appreciation for.

The Vietnamese Ministry of health with respect to <unk> $1 54 in Southeast Asia, and we will go from there.

Thanks, John maybe just a last one for me on this and that is.

Nick Abbott: Are you, I mean, obviously, you've got the booster study going, but that's a small study, I think?

Are you planning I mean, obviously, you've got the booster study going but that's a small study I think clinical trials don't go up at that 72 patients for the trial.

Nick Abbott: small study, I think clinical trials.gov had 72 patients for the trial, which is a prime boost

Which is prime boost.

And as you know a booster dose.

Nick Abbott: Just prime boost and as a booster dose.

Are you in.

Joseph E. Payne: Vinbiacare planning to more formally study a booster, 154 is a booster in Vietnam? Well, we already have an active booster trial ongoing in Singapore and the United States. This is something that is clearly a significant opportunity. This heterologous boosting, mixing, and matching is now being readily accepted globally from multiple ministries of health. So it presents an opportunity to help transition those that have never received a messenger RNA vaccine or other types of vaccines and transition them over to the messenger RNA side. So that does reflect a significant opportunity. So we are speaking about this regularly and looking at opportunities to, you know, collect more data with respect to using our vaccines as boosters, no doubt. Okay.

Then by kind of planning to more formally study.

<unk>.

Tourism boosted in Vietnam.

Well, we already have an active boost booster trial ongoing in Singapore, and the United States.

This is something that is clearly.

And a significant opportunity this header our longest boosting it mixing and matching is now being readily accepted globally from multiple ministries of health. So it presents an opportunity to help transition those that have never received a messenger RNA vaccine.

Different types of vaccines and transition them over to the messenger RNA side, so that that does reflect a significant opportunity. So we are speaking about this regularly and looking at opportunities to.

To collect more data with respect to using our vaccines as boosters hotel.

Okay, great. Thanks, Joe.

Nick Abbott: Okay, great. Thanks, Joe.

Yeah.

Operator: Our next question comes from the line of Brian Chang with Cantor Fitzgerald. Please proceed with your question.

Our next question comes from the line of Brian Cheng with Cantor Fitzgerald. Please proceed with your question.

Brian Chang: Hey guys, thanks for taking my question. So it seems that the Vietnamese government is pretty receptive to mixing different vaccines. From our research, it seems that they have allowed mixing of Pfizer and Astra-Sanika vaccines. They also allow Pfizer and Materna vaccines. And as you pointed out, that a third of the population is now fully vaccinated, and there's still quite a bit of shortage in the region. So how receptive do you think the government will give you the green light to be mixed with other vaccines and have one more follow-up?

Hey, guys. Thanks for taking my question. So it seems that the Vietnamese government.

That's pretty receptive in mixing different vaccines.

From our research it seems that they have out loud mixing of Pfizer with astrazeneca vaccines, they allow faster and better in a vaccines.

And as you pointed out that a third of the population is now fully vaccinated and there is still a quite bit of shortage in the region. So how receptive do you think that Catherine will give you the green light to be mixed with other vaccines and I have one more follow up thanks.

Joseph E. Payne: Yeah, I think that acceptance is assumed at this point based upon the FDA approving mixing and matching. But we haven't had specific discussions on that with them at this point. But you can appreciate that the VIN group, where VIN biotech is building a facility, a substantial state-of-the-art facility next year, and a large portion of those manufactured vaccines will be intended as boosters, no doubt.

Yeah, I think that acceptance is assumed at this point based upon the FDA approving mixing and matching.

But we haven't had specific discussions on that with them at this point, but but you can appreciate that the Vin group within biotech is building a facility a substantial state of the art facility next year.

The large portion of those manufacture vaccines will be intended as boosters no doubt.

Brian Chang: Okay, and then on the Vingrup front, it seems that they also facilitated the REMDesvier distribution in Vietnam earlier this year. Can you give us some color on how VIN Group is gearing up for the launch? And since they already seem to have some distribution in place for Remdesivir, do you anticipate them to have to ramp up significantly for your COVID vaccine launch? Well, you're right. There's strength in numbers.

Okay, and then on the Venmo upfront it seems that they also facilitated the ramp that's a fair distribution in Vietnam.

Earlier this year.

Can you give us some color on how when Corp is gearing up for launch.

And since they already seems to have some distribution in place for them. That's a fear do you.

Do you anticipate them to have to ramp up significantly.

Significantly for your Covid vaccine launch thanks.

Joseph E. Payne: Well, you're right, they're strengthening their position in the COVID space. I just want to remind the folks on the call that our relationship with VIN Group and Vyotech is exclusively limited to the area of Vietnam.

Well youre right theres strengthening their position in the Covid space or our relationship I just wanted to remind.

Folks on the call that our relationship with Vin and group and within biotech is exclusively limited to the area of Vietnam. So that's going to be where they have the most expertise and the ability to to facilitate a very successful launch they are extremely well known and warmly endorsed by the president and per our conversation with.

Joseph E. Payne: So that's going to be where they have the most expertise and the ability to facilitate a very successful launch. They're extremely well-known and warmly endorsed by the president, and for our conversation with him when I met him personally, he warmly introduced and endorsed it in the group and the CEO of biotech. So we have good partners with respect to Vietnam, no doubt. We have no concerns about a commercial launch.

When I met him personally.

Normally introduced and endorsed within the group.

And the CEO of in biotech so.

Sure.

We have good partners with respect to Vietnam, No doubt, we have no concerns about a commercial launch in Vietnam.

Great. Thanks.

Operator: Our next question comes from the line of Seamus Fernandez with Guggenheim. Please proceed with your question. Oh, thanks for the questions, guys. I have a few here.

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

Well thanks for the question guys. So a few here.

First off can you just help us better understand the.

Seamus Christopher Fernandez: First off, can you just help us better understand the head-to-head basically providing an additional pathway to approval? I'm just trying to get a better understanding.

The head to head basically providing an additional pathway to approval.

I'm, just trying to get a better understanding.

Of.

Seamus Christopher Fernandez: What the feasibility is of the efficacy study at this point, and if patients who receive placebo,

What the feasibility is of the efficacy study at this point.

If patients who received placebo.

Seamus Christopher Fernandez: in your study will be crossed over or can get the vaccine. We've seen this be a bit of a problem, quite a significant problem for some other clinical programs kind of trying to operate placebo controlled studies. That's my first question. I just want to clarify if the

In your study will be crossover or.

Can can get vaccine, we've seen that be a bit of a problem quite a significant problem for some other.

Clinical programs kind of trying to operate a placebo controlled studies that that's my first question I just want to clarify.

If the efficacy study itself rather than the Immunogenicity study.

Seamus Christopher Fernandez: the efficacy study itself rather than the immunogenicity study,

Seamus Christopher Fernandez: and ethnicity study can actually achieve an event-based completion. Well, we definitely have two shots on goal, but that's the intent.

Ken actually.

Steve and event based completion.

Well, we definitely have two shots on goal but.

Stephen L. Eck: Steve, maybe you can comment on, So yeah, so thanks for the question, Chemis. Both parts of the study are still in play at the moment. And you may have noticed that the event rate in Vietnam was going down, but now that they've eased restrictions in Vietnam, it is climbing back up again. So I think the door is still open to get enough events. And you remember that both the Pfizer and the Moderna study got very large numbers of events within a very short period of time this time last year.

That's the intent Steve maybe you can comment on.

Yeah. So thanks for the question centers they.

The first part of the study.

And play at the moment still.

And.

Might have noticed that the event rate in Vietnam that was going down now that they've eased restrictions in Vietnam is climbing back up again, so I think the door is still open to get enough events and you remember that both Pfizer and the Madonna study got very large numbers of events within a very short period of time.

Last year, so so it still remains possible.

Stephen L. Eck: So it still remains possible for us to get enough events to do the event-based comparison. But what's happened more recently, and I think it's possibly been driven by the announcement from the Consortium of Canada, Singapore, the United Kingdom, Australia, etc., about an immunogenicity non-inferiority route to registration. So they published their guidance document about how to achieve registration through an immunogenicity and non-inferiority comparison with an already licensed vaccine. And I think Vietnam is kind of following suit with that, and they've recently issued some guidance around what the pathway to registration based upon that kind of comparison would be.

For us to get enough events to the event base comparison.

What's happened more recently.

And I think possibly been driven by the announcement from the consortium of Canada, Singapore.

The United Kingdom, Australia et cetera about.

An immunogenicity non inferiority route to registration so they publish their guidance document about how to achieve registration for immunogenicity non inferiority comparison with an already licensed vaccine and I think Vietnam kind of following suit with that and they've recently issued some guidance around what the pathway to read.

Stripes and based upon that kind of comparison would be so we've taken advantage of that and we've taken advantage of the ministry of health enthusiasm for this study and cooperation of the study to rapidly.

Stephen L. Eck: So we've taken advantage of that, and we've taken advantage of the Ministry of Health's enthusiasm for this study and cooperation in the study to rapidly open up the immunoniniority study compared with the AstraZeneca COVID-19 vaccine. And that vaccine was basically the one that was ready to go and could be provided most quickly by the Vietnam Ministry of Health. So now we have two routes to full registration. Even in the eventuality that the event rate doesn't get to target before we have to cross the placebos over to the active vaccine, we still have the non-inferiority route to full registration in Vietnam.

Open up the <unk>.

Non inferiority study compared with the Astrazeneca COVID-19 vaccine and.

That vaccine was basically the one that was ready to go and could be provided most quickly by the Vietnam Ministry of health.

So that so now we have two routes to full registration.

Even in the eventuality that the event right.

It doesn't get to target before we have to cross the placebos over to active vaccine, we still have the non inferiority to a full registration in Vietnam and neither of those endpoints effects. The emergency use authorization, which is going to be based entirely on the phase one two and three a cohort immunogenicity data.

Stephen L. Eck: And neither of those endpoints affects the emergency use authorization, which is going to be based entirely on the phase 1, 2, and 3A cohort immunogenicity data. And I'll just add one comment, and I'll add a comment that, you know, we're working with Vietnam with respect to conducting our efficacy trial in areas that are perhaps the last, or one of the last groups to receive, an approved vaccine, and Vietnam has a really tight understanding of their citizens in terms of who's received the vaccine and who hasn't. And so this information has been leveraged by Finbiotech as well to help us achieve that. Right? You know, there's adjudicated, you know, numbers in the placebo groups.

And I'll, just add one comment and I'll add a comment that we're working with Vietnam with respect to conducting our efficacy trial in areas that are.

Perhaps last or one of the last groups to receive approved vaccines and.

In Vietnam has it really tight understanding of their citizens in terms of who's received vaccine and who hasn't and so this information has been leveraged by the fund.

Fin biotech as well.

To help us achieve that.

<unk> numbers in the placebo group.

Seamus Christopher Fernandez: And with regard to the head-to-head immunogenicity data, can you just help us understand one?

And then with regard to the head to head Immunogenicity data can you just help us understand what is the delta.

Seamus Christopher Fernandez: One is a Delta, one is Delta Delta, and one is Wuhan. What exactly is the data, and can you just help us understand what the non-inferiority margins are and why you didn't choose to pursue superiority? Maybe we've seen superiority for some other studies. So we can't comment too much on the details of the non-inferiality margins at this point in time. They are consistent with non-inferiority margins that have been used in other studies that have resulted in emergency use authorization with FDA. So the margins are very similar there. And as you would expect, the evaluations are going to be based upon both neutralizing antibodies and binding antibodies and also demonstrated ability to neutralize variants of concern.

One is delta one is move on.

What exactly is the data and can you just help us understand what the non inferiority margins are.

And why.

Didn't choose to pursue superiority.

In superiority for some other some other study.

So we cant comment too much on the details of the non inferiority margin.

At this point in time.

They are consistent with non inferiority margins that have been used in other studies that have resulted in an emergency use authorization with FDA.

So the margins are very similar to that.

And as you would expect.

Evaluations are going to be based upon.

Both neutralizing antibodies and binding antibodies and also demonstrated.

Stephen L. Eck: Okay, so basically, it's a broad immunogen.

<unk> ability to neutralize variance of concern.

Stephen L. Eck: broad immunogenicity assay comparisons. I just want to clarify that. Yeah, so the guidance that's been issued by the Vietnamese Ministry of Health is very similar to what's already in the public domain. But the Vietnamese Ministry of Guidance, as far as I can tell, isn't currently in the public domain. It was a personal communication from the Ministry of Health to our partners in Biotech and us, which is why I can't comment too much on it because it hasn't been disclosed by the Ministry of Health yet. But, broadly speaking, it is very similar to the guidance that's already been issued by the consortium of regulators, including the UK, Singapore, Health Canada, and Australian regulator about the pathway to immunone non-inferiority studies for

Yeah.

Okay. So so basically broad immunogenicity.

As a.

Comparison.

I just wanted to clarify that.

Yeah. So I think the guidance that's been issued by the Vietnamese administrative health is very similar to what's already in the Vietnamese Ministry of guidance as far as I can tell is them coming in.

In the public domain. It was a personal communication from the Ministry of health to our partners in biotech.

I think she's well I cant comment too much on it because it has not been disclosed by the ministry of health yet.

But broadly speaking, it's very similar to the guidance Thats already been issued by the consortium of regulators, including the U K, Singapore, How Canada, and Australia and regulator about the pathway to immuno non inferiority studies for registration.

Seamus Christopher Fernandez: Okay, no, that's helpful. And in terms of immunogenicity data,

Okay No that's helpful.

In terms of Immunogenicity data.

Is a curious aware of any of the Immunogenicity data do you have any of that data in hand from the.

Seamus Christopher Fernandez: of immunogenicity data Is Arturis aware of any of the immunogenicity data? Do you have any of that data in hand from the initial 1,000 patients?

Initial 1000 patients or is that.

Going to become.

Seamus Christopher Fernandez: Or is that going to become first available to you and the team closer to the end of December? And then what follows after that is EUA. And then once we know EUA, will receive it, and we'll have a fuller understanding of the immune response at that point. Is that how the disclosure is likely to work?

First available.

To you and the team are.

Closer to the end of December.

And then what.

What follows after that as EUA.

And then once we know EUA, we'll receive.

And we will have a fuller understanding of.

Immune response at that point.

How sort of the disclosure is likely to work.

Joseph E. Payne: Yeah, we don't have that data yet, and we've implied or indicated on this call that it will likely be included in the emergency use approval application. So, you know, that's where we are, and we've given the timeline for that. Anything to add, Steve?

Yeah, we don't have that data yet.

And we've implied or indicated on this call that it will be included in the emergency use.

Approval application likely so.

That's where we are in and.

And we've given the timeline for that anything to add Steve or.

Stephen L. Eck: Nothing can happen until the participants that are in that 1,000 patient cohort or participant cohort are through at least day 57 of the study, so that they have sufficient safety follow-up, and they also have the immunogenicity data from 28 days after their second dose. So there's a latency between those blood samples being drawn and then processed in the lab and us cleaning and locking the database after that day 57 time. So that kind of pushes us into the December timeframe, which is the guidance that we've previously given about timing for the EUA application. Okay, perfect, super helpful. Thanks; I'll jump in the queue.

Nothing can happen and so the participants that are in that 1000 patient cohort all participant cohort.

Or at least a 57 on the study so that they have sufficient safety follow up and they also have the immunogenicity data from 28 days. After the second dose. So there is a license sale between those blood samples being drawn and then processed in the lab and us cleaning and locking the database.

That day 57 time point, so so that kind of pushes us into the December timeframe, which is what we've gotten this that we've previously given about timing for the EUA application.

Okay perfect Super helpful. Thanks, I'll jump in the queue.

Operator: Our next question comes on the line from Diego Nakamovich, which city group?

Our next question comes from the line of Yugo knock them of Itch with Citigroup. Please proceed with your question.

Diego Nakamovich: Hi, team. This is Ashik Mubarak and Antrii Gahl. Thanks for taking my questions. I had two, I guess just building on some of the earlier questions. If maybe you miss phase three, see non-inferiority, could you still potentially file an EUA based on events maybe earlier than the timeline you laid out for full approval? And then my second question would be, how are you thinking about

Hi, Tim This is <unk> on for Yigal. Thanks for taking my questions I had two.

I guess just building on some of the earlier questions. If maybe you missed on the phase III <unk> non inferiority could you still potentially file in the UA based on events, maybe earlier than the timeline you laid out for full approval.

And then my second question would be how are you thinking about pediatric vaccination.

Diego Nakamovich: How are you thinking about pediatric vaccination, you know, given the rates you mentioned for adults and adolescents in Vietnam? Thanks.

Given the rates you mentioned in adults and adolescence and Vietnam.

Joseph E. Payne: Well, if there's an additional wave or unexpected wave of infections that accelerate the adjudicated infections in the placebo group, then yes. But it's difficult to impossible to predict those type of things. So we stay away from guiding based on that. But technically, yes.

Well, if there's a if there's a an additional wave or unexpected wave of infections that accelerate the adjudicated infections in the placebo group and yes, but it's difficult to impossible to predict those types of things. So we stay away from guiding based on that but yes.

Yes, technically yes, it's possible.

Stephen L. Eck: And then, with relation to the children, we're obviously focusing hard on how we move from the current study into other at-risk groups. And also, that would include boosting and the heterologous type of boosting as well. And so we're having discussions with our partners about what the appropriate timing for a pediatric study would be and how we would go down the age groups. As you know, the currently available vaccines for pediatric populations didn't go straight into young kids.

And then with relation to the children were obviously focusing hard on how we move from the current study into other.

At risk groups.

And also that would include boosting and that the actual logos taught the boosting as well and so.

So we're having discussions with our partners about what the appropriate timing for a pediatric study would be and how we would.

Go down the age groups.

No. They currently.

Available vaccines for the pediatric populations didn't go straight into young kids.

Stephen L. Eck: They went into adolescence, and then they stepped it down from adolescents to the 5 to 12 range, and then from the 2 to 5 range. So that's the well-trodden path for this kind of work, and that's a path that we're obviously looking at very carefully.

We went into adolescence and then they stepped it down from adolescence.

<unk> thought to 12 range and then from the two to five range. So that's the well trodden path for this kind of for this kind of work and that's the path that we're obviously looking at very carefully.

Diego Nakamovich: The other thing just to note for the pediatric studies is that they haven't been based on event rates. So in the pediatric populations, they've been largely based upon an immunodeficiency bridging between the adult and the pediatric population, and I would anticipate that that would be the route to pediatric approval for us as well.

The other thing just to note that the pediatric studies is that they haven't been based on Eventbrite. So in the pediatric population they've been largely based upon an immuno bridging between the adult and the pediatric population.

I would anticipate that that would be the pediatric approval class as well.

Operator: Okay, okay, thank you very much.

Okay. Okay. Thank you very much.

Thank you.

Yale Jen: Our next question comes from the line of Yale, Jen, with Laidlaw and Company. Please proceed with your question. Good afternoon.

Our next question comes from the line of Yale Jen with Laidlaw <unk> Company. Please proceed with your question.

Good afternoon, and again congrats on the rapid the progressions.

Yale Jen: and again, congrats on the rapid progression. My first question is that giving the approval in Vietnam seems very likely, and should investors start to think about the potential sort of revenue, or in what form of shape of revenue, a tourist may receive from the foundation?

My first question is that.

Given the approval even been done James Oh, they're likely and should investors start to think about the potential sort of revenue or in what form or shape of revenue.

Joe risk might be a receiver from day, one that is the best ever.

Yale Jen: and they set, from that successful effort.

Yeah.

Yale Jen: Well, revenue guidance is always a challenge. I'm going to throw that one to our CFO, Andy.

Our revenue guidance is always a challenge I'm going to throw that one to our CFO Andy.

Andrew H. Sassine: Anything on revenue guidance? We unfortunately do not provide guidance with respect to revenues. We did, you know, share some trends with respect to expenses and earlier in the call, and we did kind of share the cash runway to give you kind of a perspective of how many quarters of operating cash we have. So I hope that is helpful. But, you know, it is different. to forecast revenue with a biotech company. I hope you can appreciate that.

Anything on revenue guidance.

Unfortunately, we do not provide guide.

Guidance with respect to our revenues.

We did share some some.

Some trend with respect to expenses and.

Earlier in the call and we did kind of share the cash runway to give you kind of a perspective.

How many quarters of operating cash do we have so I hope that is helpful.

But you know it is difficult to forecast.

As a biotech company I hope you can appreciate that and it's important to stress that we do have the manufacturing footprint in place.

Yale Jen: And it's important to stress that we do have the manufacturing footprint in place to support, you know, Okay, great, that's helpful. And then we have one more question here, which is related to the booster that you have Singapore and you have the U.S. study. What should we think about the next step in terms of the trials? And would that be facilitating potential approval maybe in the U.S. or in Singapore, possibly next year? And thanks.

To support.

Decent numbers of vaccines.

Okay, Great. That's helpful and maybe one more question here, which is related to the booster that you'll have Singapore and then you have the U S study.

What should we think about the next step in terms of the trials.

And would that be facilitating a potential approval maybe you are.

Or in Singapore, or possibly in next year.

Thanks.

Stephen L. Eck: Yeah, so the current booster studies that we have are to give us an idea of how our three vaccines that are the furthest forward, 021, 154, and 165, behave in the booster setting, all at the same dose, and also comparatively in the priming vaccination series. So it gives us a very good data set to start making some assumptions and to allow us to design subsequent clinical trials that would be registration-focused. So I don't think that the 76 participants that we have in the US and Singapore clinical trial in itself will be sufficient to enable registration, but it will definitely be sufficient to form the basis for starting additional clinical trial work in that space.

Yes.

Booster studies that we have to give us an idea of how the.

Three vaccines that are furthest forwards there are 21154 months six five behaving the booster setting.

All at the same dose then also comparatively and the priming vaccination series. So it gives us a very good dataset to start making some assumptions and to allow us to.

So design subsequent clinical trials that would be registration focus. So I don't think that the 76 participants that we have in the U S and Singapore clinical trial.

In itself will be sufficient to enable registration, but it will definitely be sufficient to form the basis for starting additional clinical trial work and.

Stephen L. Eck: And we actually also have another study that's ongoing, our phase two study of ARCT 021 that's being conducted in the United States and Singapore and has been ongoing since the beginning of the year. In that study, we're actually boosting the participants at the six-month time point with either 021, 154, or 165. So we've got two studies where we're looking at getting booster information.

That space and we actually also have another study thats ongoing a phase two study of <unk> two one that's being conducted in the United States and Singapore, and it's been ongoing since the beginning of the year that study with actually boosting.

The participants at the six month time point with either a zero to 11416 points. So we've got two studies, where we are we're looking at getting booster information.

Maybe just squeeze one more question when you mentioned that 76 patient study.

Stephen L. Eck: Maybe just please one more question: when you mentioned that 76 patients study, is there a plan to provide some redoubt for that study?

Is there a plan for providing them readout for that study.

I'm sorry.

Stephen L. Eck: So the cohort of participants in the study that's receiving the vaccines as a booster is fully recruited, and so we would anticipate having the immunogenicity data through day 29 for that cohort in the Q1 timeframe next year. The other half of the study is the priming vaccination series, again with the same vaccines, but recruitment in those cohorts is still ongoing. And so at this point, I can't give guidance about when we will have data for those cohorts.

The cohort of participants in the study that's receiving the vaccines as a booster is fully recruited and so we would anticipate.

<unk>.

<unk> the data through day 29 for that cohort in the Q1 timeframe next year.

The other half of the study is the priming vaccination service.

Again with the same vaccines, but.

And that those cohorts is still ongoing.

And so at this point I can't give guidance about when we would have.

Data for those cohort.

Yale Jen: Okay, great. Thanks a lot. I really appreciate it.

Okay, great. Thanks, a lot I really appreciate it.

Operator: Our next question comes from the line of Kumar Rajah with Brookline Capital Markets. Please proceed with your question.

Okay.

Our next question comes from the line of Kumar Roger with Brookline Capital markets. Please proceed with your question.

Kumar Rajah: Thanks for taking my questions. And with regard to the ARCT 021 trial that would be conducted by the global entity, what can you share with regard to that? You know, when do you think we can get more clarity on that? And why was 021 selected there versus the other ones? And also, with regard to the HBB program, can you share what this milestone was and what the next steps in this collaboration are?

Thanks for taking my questions.

And with regard to the <unk> zero to one trial that could be conducted.

By the global ETP.

What can you share with regard to that.

When do you think we can get more clarity on that.

And why was zero to one day to work with.

The other one.

And also with regard to the hits BV program can you share what might've gone off and what are the next steps in this collaboration thanks.

Kumar Rajah: Yeah, with respect to the ARCTO21 study. You know, we've disclosed everything we can up to this point, but just per our agreement, we're unable to discuss further specifics. It's a great question, it's a fair question, but we're just unable to comment further. And the second part of your question was with respect to the HBV program. Yeah, we have a great relationship with J&J.

Yeah with respect to the.

Yes.

Our CTO to one study.

We.

We've disclosed everything we can up to this point, but just per our agreement we're unable to discuss further specifics.

Great Great question, It's a fair question, but we're just unable to comment further.

And the second part of your question.

With respect to the HBV program Yeah.

Have a great relationship with J&J, we continue to progress that program with them, it's an ongoing program in.

Joseph E. Payne: We continue to progress that program with them. It's an ongoing program, and, you know, we announced that we received a milestone successfully with them, and we view that as a positive, additional positive validation of our platform, especially with intravenously-dosed and systemically administered Okay, thanks, and maybe with regard to the cystic program, what's happening there, and when can we get updates? Well, the CF program, we have been, there's been some additional data presented at the, there was a national CF conference, and we can provide that to you separately in an email, but it showed some promising data and well-established models and ferret models of cystic fibrosis. So it continues to mature.

We announced that we received a milestone successfully with them.

<unk>.

And we view that as a positive.

Additional positive validation of our platform, especially with intravenously, dosed and systemically administered messenger RNA.

Okay, Thanks, and maybe with regard to the <unk> program.

What's happening there and when can we get an update.

Okay.

Oh, the CF program, we have been there's been some additional data presented at the <unk>.

There was a national CF conference.

And we can provide that to maybe separately in an email, but it showed some promising data and well established models and ferret models of cystic fibrosis.

So it continues to mature the preclinical data package matures while in parallel.

Joseph E. Payne: The preclinical data package matures while in parallel. We're, you know, preparing to go through all the, you know, the pre-I&D enabling studies, or the IND enabling studies and toxicology studies for that. And maybe finally, what is the latest with regard to the two programs? What's the latest with respect to the flu program, did you say? Yeah, that's still on. Yeah, that's on track for next year. We indicated that the I&D or CTA would be filed in the second half of next year.

Preparing to go through all the.

The pre IND, enabling studies or the IND, enabling studies and toxicology studies for that for that for that program.

And maybe finally, what is the latest with regard to the approved program. Thanks.

The latest with respect to the flu program did you say.

Yes, that's still on yeah.

That's on track for next year, we indicated that the IND or Cta would be filed in the second half of next year.

Kumar Rajah: Great, thanks. Yes, thank you. Our next question comes from the line of Yasmin Rahiming with Piper Sandler. Please proceed with your question.

Yes.

Great. Thanks.

Yes, Thank you Tamara.

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

Yasmeen Rahimi: Thank you so much for taking my follow-up question. Joe and Steve, you commented on Seamus' question on whether you had seen any immunogenicity data from the first thousand patients or not that those data have not been shared yet. But can you comment on whether the Vietnam Health Administration has seen some preliminary data, or have they made their decisions just on the safety basis to really expedite it to, you know, from a phase one to phase two into a 16,000 phase three study? And thank you for taking my follow-up question.

Thank you so much for taking my follow up question.

Joe and Steve.

Commenting on just staying with the question on whether you had seen any immunogenicity data from the first thousand patients at that dose data have not been shared yet but can you comment on the weather.

Hum.

We have seen some preliminary data or have they made their decision on the safety data to really expedite end too.

From a phase one to phase two until at 16000 Phase three study and thank you for taking my follow up question.

Yeah, I can reiterate the timeline and then turn the time over to Steve, but you know in mid August we initiated the phase one.

Joseph E. Payne: I can reiterate the timeline and then turn the time over to Steve, but in mid-August we initiated phase one, which means the second shot was in mid-September, and a month after that is mid-October, when the blood draw is taken. So the blood to which you're referring was drawn in mid-October With respect to the timing of the data, and to what extent they understand the immunogenicity data, maybe Steve, you can comment. Yes, so far as we know, the Ministry of Health hasn't seen any immunogenicity data, and the timing of processing those samples wouldn't really have allowed them to see immunogenicity data prior to moving the study from one phase to the next.

Which means the second shot was mid September and a month after that as mid October where the blood draw is taken so the the blood to which you are referring to as it was drawn in mid October with respect to timing of the data and to what extent they understand the immunogenicity data, maybe Steve you can comment.

Yes.

As far as we know.

The Ministry of health hasn't seen any immunogenicity data and the timing of assessing those samples wouldn't really have allowed them to see immunogenicity data prior to moving the study from one place to the next.

Joseph E. Payne: So the immunogenicity data readout from those 1,000 participants isn't going to be back. So the relevant time point, which is day 57, that isn't going to be back from the lab until the end of November or early December. So all of their assessments so far in terms of moving the study rapidly from one phase to the next have just been focused on whether it's safe to dose progressively larger numbers of individuals.

The Immunogenicity data readout from those 1000 participants isn't going to be back. So the relevant time points, which is down 57% that isn't going to be back from the lab until the end of November or early December.

So all of that assessment, so far in terms of moving the study rapidly from one place to the next is just been focused on whether it's safe to dose progressively larger numbers of individuals.

Stephen L. Eck: Thank you so much.

Thank you so much kind of clarity.

Operator: That is all the time we have for questions. I'd like to hand the call back to management for closing remarks. Hey, great, thank you, Doug. This concludes our third quarter update, and thank you for joining us this afternoon to talk about our progress. Please reach out to us right away with your questions if you're unable to accommodate you today. We look forward to updating you further throughout the balance of the year, and hope you all have a great year. Ladies and gentlemen, this does include today's teleconference. Thank you for your participation. You may just have

That is all the time, we have for questions I'd like to hand, the call back to management for closing remarks.

Hey, great. Thank you Doug This concludes our third quarter update and thank you for joining US. This afternoon to talk about our progress. Please reach out to US right with your questions. If you are unable to accommodate you today, we look forward to updating you further throughout the balance of the year and hope you all have a great evening.

Bye for now.

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation you may disconnect. Your lines at this time and have a wonderful day.

Operator: Connect your lines at this time and have a wonderful day.

Yes.