Q4 2021 Arcturus Therapeutics Holdings Inc Earnings Call
Greetings and welcome to the Arcturus Therapeutics fourth quarter and full year 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 operator assistance. During the conference. Please press star zero on your telephone keypad. Please note. This conference is being recorded I will now.
Operator: Welcome to the Arcturus Therapeutics 4th Quarter and Full Year 2021 Earnings Call. At this time, all participants are in a listen-only mode.
Operator: A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note, this conference is being recorded. I will now turn the conference over to your host, Dipankar Roy, Senior Director of Investor Relations. Thank you, Kyle.
Turn the conference over to your host the Ponca ROI Senior director of Investor Relations you may begin.
Thank you Kyle and good afternoon, and welcome to Arcturus Therapeutics fourth quarter and full year 2021 financial results and corporate update call. Thank you all for joining US today's call will be led by Joseph Payne President and CEO .
Dipankar Roy: Good afternoon, and welcome to Arcturus Therapeutics' fourth quarter and full year 2021 financial results and corporate update call. Thank you all for joining us. Today's call will be led by Joseph Payne, President and CEO; Andy Sassine, our CFO; and Dr. Pad Chivukula, our CSO and COO. 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.
Dipankar Roy: Forward-looking statements are not guarantees of performance, and they involve known and unknown risks, uncertainties, and assumptions that may cause actual results to vary. As a result, performance and achievements may differ materially from those expressed or implied by the statement.
And this has seen our CFO and Dr perpetual cooler C.
C S O N C O O.
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 and involve known and unknown risks uncertainties and assumptions that may cause.
Cause actual results to vary from.
The 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 as well as the risk factors section in our Form 10-K filed with the SEC.
Dipankar Roy: 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 Form 10-K, filed with the SEC. In addition, any forward-looking statements represent our views only as of the date such statements are made, February 28, 2022, and Arcturus specifically disclaims any obligation to update such statements to reflect future information, events, or circumstances. With that, I'll talk to him over the call to Jill. Jill.
In addition, any forward looking statements represent our views only as of the date such statements I mean February 28, he tried and true and after specifically disclaims any obligation to update such statements to reflect future information events or circumstances that are long term over the call to Joe Joe Hey, Thank you to tanker.
Jill: Okay. Thank you, Deepanker. Good afternoon to all.
Hi, good afternoon to all thank you for joining Arcturus has quarterly call today.
Before we begin I would just like to acknowledge that today is national rare disease day February 28, and given that two of our pipeline programs are rare diseases. You know that is OTC deficiency, a rare liver disease and cystic fibrosis, a rare long centric disease I wanted to publicly express my gratitude to.
All of those working diligently on these programs here at Arcturus and to the clinicians and patients and families on this national day of recognition.
Now onto our update about our recent progress.
Jill: I wanted to publicly express my gratitude to all those working diligently on these programs here at Arcturus and to the clinicians, patients, and families on this National Day of Recognition. Now on to our update about our recent progress. We have continued to make excellent progress advancing our mRNA-based vaccines and therapeutic candidates.
We have continued to make excellent progress advancing our mrna based vaccines and therapeutic candidates I'll begin with a discussion of our vaccine programs targeting COVID-19.
Jill: I'll begin with a discussion of our vaccine programs targeting COVID-19. So let's begin with ARCT 154, our most advanced program and a vaccine that is designed to protect against the SARS-CoV-2 variants of concern. This program is supported by encouraging clinical data, including the recent booster data we reported showing that a low dose of only 5 micrograms of ARCT154 boosted or increased neutralizing antibody activity against the SARS-CoV-2 ancestral D614G and Omicron strains by 28 and 54-fold respectively.
So let's begin with a a R. C. T 150 for our most advanced program and a vaccine that is designed to protect against the SAR C. O V. Two variance of concern.
This program is supported by encouraging clinical data, including the recent booster data, we reported showing that a low dose of only five microgram. So they are C. T 154, boosted or increased neutralizing antibody activity against the SAR C. O V. Two ancestral D 614, G and omicron strains.
By 28, and 54 folds respectively.
We are excited to announce today that our collaborative urban bio care has completed an emergency use authorization filing with the Vietnam Ministry of health for a C. T. 154. This represents a very important milestone for our company as we mature and strive towards becoming an integrated commercial stage.
Jill: We are excited to announce today that our collaborator, VinBioCare, has completed an emergency use authorization filing with the Vietnam Ministry of Health for ARCT 154. This represents a very important milestone for our company as we mature and strive toward becoming an integrated commercial stage global biopharmaceutical company. ARCT154 is a product of our self-amplifying mRNA technology or the trademarked STAR platform. In addition, this vaccine includes an optimized mRNA sequence with multiple proprietary modifications to improve its stability, half-life, and increase its translation. We believe that these modifications and others incorporated into ARCT154 improve the immunogenicity profile of this vaccine candidate and may enable high levels of clinical efficacy, especially as a boost.
Global Biopharmaceutical company.
A R. C T 154, as a product of our self amplifying mrna technology or the trademark star platform. In addition, this vaccine includes an optimized mrna sequence with multiple proprietary modifications to improve its stability half life and and increase its translation, we believe that these modifications and others.
Right it into a RCT $1 54 improve the Immunogenicity profile of this vaccine candidate and May enable high levels of clinical efficacy, especially as a booster.
Our C. T 154 is designed to extend the duration of antigen expression and this platform has shown robust T cell responses and high levels of humoral immunity in multiple preclinical models.
Jill: ARCT 154 is designed to extend the duration of antigen expression, and this platform has shown robust T-cell responses and high levels of humoral immunity in multiple preclinical studies. We've also been efficient in progressing 154 into clinical studies. We designed and developed this vaccine very rapidly based on our understanding of mutations in the clinically relevant variants circulating across the world. And we expeditiously moved this program into the clinic in combined phases 1, 2, 3.
We've also been efficient and progressing $1 54 in clinical studies, we designed and developed to this vaccine very rapidly based on our understanding of mutations in the clinically relevant variance circulating across the world and we expeditiously move this program into the clinic and a combined.
As 123 study.
Earlier in this quarter, we announced highly encouraging image Immunogenicity phase one slash two booster data from our a R. C. T 154 program as well as our alternative E. R. C. T 165 vaccine candidate. These data showed that when administered at low five microgram doses.
Jill: Earlier in this quarter, we announced highly encouraging immunogenicity phase 1-2 booster data from our ARCT 154 program, as well as our alternative ARCT 165 vaccine candidate. These data showed that, when administered at low 5-microgram doses at least five months following initial vaccination with Comirnaty, we observed robust increases of 54 and 47-fold, respectively, in neutralizing antibody responses against the Omicron variant for these two booster vaccine candidates in an exploratory
At least five months following initial vaccination with commonality.
We observed robust increases of 54, and 47 fold, respectively, and neutralizing antibody responses against the Omicron variant for these two booster vaccine candidates in an exploratory micro neutralization assay.
Yes. It is in addition to the data that showed broad coverage and encouraging a neutralizing antibody activity of these candidates against the D 614, G ancestral beta Delta and several other variance of concern and variance of interest using validated and exploratory neutralization assay.
Jill: This is in addition to the data that showed broad coverage and encouraging neutralizing antibody activity of these candidates against the D614G ancestral, beta, delta, and several other variants of concern and variants of interest using validated and exploratory neutralization. These results provide us with confidence in the potential for ARCT-154 to provide substantial clinical efficacy against a wide range of circulating variants. So, supported by these strong data, our goal is to develop ARCT154 as a broadly immunogenic vaccine that can be used for primary and booster vaccination.
These results provide us with confidence in the potential for a R. C. T $1 54 to provide substantial clinical efficacy against a wide range of circulating variance.
So it was all supported by the strong data our goal is to develop a R. C. T 154, as a broadly immunogenic vaccine that can be used for primary and booster vaccination. We aim to explore its potential use in populations currently seeking vaccination for initiation of or continue.
Jill: We aim to explore its potential use in populations currently seeking vaccination for the initiation of or continuation of protection against severe COVID-19 disease. We are working closely with our collaborator, VinBioCare, to operationalize the phase 1, slash 2, slash 3 study of ARCT154 in Vietnam. The study objectives include the evaluation of safety, immunogenicity, and efficacy of ARCT154 against SARS-CoV-2 infection.
Asian of protection against severe COVID-19 disease, we are working closely with our collaborator Vin bio care to operationalize the phase one slash two slash three study of <unk> $1 54 in Vietnam. The study objectives include the evaluation of safety Immunogenicity.
And efficacy of <unk> $1 54 against Sars Covid two infection all of the cohorts in the study, meaning phase 12383, B and three C have all completed two doses of a R. C T 154, or comparator given 28 days apart.
Jill: All of the cohorts in this study, meaning phase 1, 2, 3A, 3B, and 3C, have all completed two doses of ARCT154 or comparator given 28 days apart. The safety and immunogenicity data from the first 1,000 participants of the Phase I, II, and IIIa cohorts are included in the EUA application that was submitted today. Efficacy data from the pivotal trial will be subsequently submitted to the Ministry of Health in application for potential full approval.
The safety and Immunogenicity data from the first 1000 participants of the phase one slash two slash three a cohorts are included in the EUA application that was submitted today.
Efficacy data from the pivotal trial will be subsequently submitted to the ministry of health in application for a potential full approval.
In addition, our global manufacturing footprint continues to mature.
Jill: In addition, our global manufacturing footprint continues to mature, and our technology transfer to VinBioCare's manufacturing facility in Hanoi, Vietnam, continues to progress toward anticipated production capacity of 200 million doses per year. We remind everyone that this trial and the development of the Hanoi Manufacturing Facility are fully sponsored and funded by VinBioCare, and we are indeed grateful for their support. I will now turn to ARCT 810, our therapeutic candidate for ornithine transcarbamylase deficiency or OTC deficiency.
Our technology transfer to Vin bias cares manufacturing facility in Hawaii, Vietnam continues to progress toward anticipated production capacity of 200 million doses per year.
We remind everyone that this trial in the development of the annoy manufacturing facility is fully sponsored and funded by Vin bio care and we are indeed grateful for their support.
I will now turn to a R. C T 810, or therapeutic candidate for ornithine transcribe families deficiency or OTC deficiency or.
Jill: OTC is a rare and serious disease with no approved treatments that address the root cause of death. Artherapeutic Candidate aims to restore expression of the normal ornithane transcarb amylase enzyme in the liver of patients with OTC division.
OTC is a rare and serious disease with no approved treatments that address the root cause of the disease are therapeutic candidate aims to restore expression of the normal ornithine Trans carb amylase enzyme in the liver of patients with OTC deficiency.
Our C. T. A 10 has the potential to restore urea cycle activity prevent neurological damage and prevent the need for liver transplantation.
Jill: ARCT-810 has the potential to restore urea cycle activity, prevent neurological damage, and prevent the need for liver transplantation. We previously completed a Phase I Healthy Volunteer Dose Escalation Study with ARCT-810 and demonstrated that ARCT-810 administration was associated with favorable tolerability and an attractive pharmacokinetic profile. Lipid excipients were no longer observed in the plasma after 48 hours.
We previously completed a phase one healthy volunteer dose escalation study with a our Cta 10 and demonstrated that <unk> T. A 10 administration was it associated with favorable tolerability and an attractive pharmacokinetic profile.
Lipid excipient, so we're no longer observed in the plasma after 48 hours.
The doses we are now clinically evaluating are within the anticipated therapeutic range that we have estimated based upon our preclinical studies I'm happy to report that the phase one b trial for adults with OTC deficiency is now identifying additional patients for screening after COVID-19 related delays and we expect to complete dosing in the.
Jill: The doses we are now clinically evaluating are within the anticipated therapeutic range that we have estimated based upon our preclinical studies. I'm happy to report that the Phase 1b trial for adults with OTC deficiency is now identifying additional patients for screening after COVID-related delays, and we expect to complete dosing in the first cohort in the second quarter. We have obtained approval from the United Kingdom Health Research Authority, as well as from Belgium and Spain, to initiate a phase two multiple dose clinical trial for ARCTA 10.
First cohort in the second quarter.
We have obtained approval from the United Kingdom Health Research authority, as well as from Belgium, and Spain.
To initiate a phase two multiple dose clinical trial for <unk> 10.
And we continue to conduct site startup activities, while seeking authorization in additional European countries.
Jill: And we continue to conduct site startup activities while seeking authorization in additional European countries. This is a randomized placebo-controlled double-blind study with a nested single and multiple ascending dose design that would enroll 24 adolescents and adults with OTC deficiencies.
This is a randomized placebo controlled double blind study with a nested single and multiple ascending dose design that would enroll 20 for adolescents and adults with OTC deficiency.
We anticipate that phase two screening will commence in the second quarter and we expect to obtain interim data in the second half of 2022 and a subset of participants.
Jill: We anticipate that Phase 2 screening will commence in the second quarter, and we expect to obtain interim data in the second half of 2022 in a subset of participants. Moving now to our Cystic Fibrosis Program, we have continued to progress the necessary pre-clinical studies to enable ARCTO32, our mRNA therapeutic candidate for cystic fibrosis, to move into clinical studies.
Moving now to our cystic fibrosis program.
We have continued to progress the necessary preclinical studies to enable a R. C. T. O 32. This is our mrna therapeutic candidate for cystic fibrosis to move into clinical studies, we anticipate the submission of a clinical trial application for a R. C. T O 32 in the third quarter of 2022.
Jill: We anticipate the submission of a clinical trial application for ARCTO32 in the third quarter of 2022. Our flu vaccine program, termed Lunar Flu, also continues to progress toward candidate selection and clinical development. We believe that self-amplifying mRNA vaccines have tremendous promise to address the gaps with the current flu vaccines, which often suffer from suboptimal efficacy and require lengthy manufacturing and release. In addition, mRNA-based vaccines potentially have the advantage of being able to be adapted through much more rapid mRNA manufacturing processes to target currently circulating flu strains.
Our flu vaccine program termed lunar flu also continues to progress towards candidate selection clinical development, we believe that self amplifying mrna vaccines have tremendous promise to address the gaps with the current flu vaccines, which often suffer from some suboptimal effort.
C and required lengthy manufacturing and release.
In addition, mrna based vaccines potentially have the advantage of being able to be adapted through much more rapid mrna manufacturing processes to target currently circulating flu strains.
We expect to make a final selection of our lunar flu development candidate this year with a self amplifying star platform candidate and advance toward a clinical trial application in 2023.
Jill: We expect to make a final selection of our Lunar Flu Development Candidate this year with a Self-Amplifying Star Platform Candidate and advance toward a clinical trial application in 2020. In addition to these internally developed programs, Arcturus has also partnered several of our lunar therapeutic programs with some of the leading biopharmaceutical companies, including Ultragenyx, J&J, and Takeda. The most advanced of these programs is a very promising therapeutic candidate for glycogen storage disease, which is currently being evaluated by Ultragenyx in a phase 1-2 study.
In addition to these and internally developed programs Arcturus has also partnered several of our lunar therapeutic programs with some of the leading biopharmaceutical companies, including ultra Genex and J&J and Takeda. The most advance of these programs is a very promising therapeutic candidate for glycogen storage disease, which is <unk>.
Currently being evaluated by ultra genetics, and a phase one slash two study.
I will now pass the call onto Andy our CFO .
Andy Sassine: I will now pass the call on to Andy, our CFO. Thank you, Joe, and good afternoon, everyone. The press release issued earlier today includes financial statements for the fourth quarter of fiscal year 2021 and provides a summary and analysis of the year-over-year and sequential financial performance. Please refer to our 10-K for more details on the financial performance. I will go over our financials and present some operating metrics as we continue to transition to a late stage clinical company with several assets in our pipeline.
Thank you Joe and good afternoon, everyone.
The press release issued earlier today includes financial statement for the fourth quarter and fiscal year 2021, and provides a summary and analysis of the year over year and sequential financial performance.
Please please reference our 10-K for more details on our financial performance.
I will go over our financial and present, some operating metrics as well.
We continue to transition to a late stage clinical company with several assets 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.
Finally, I will provide some insights regarding our cash position and expected run rate.
And you heard Joe mentioned, we had a very productive Q4, and 2021, including the completion of our clinical trial in Vietnam and encouraging human trial result, and our Ark 154 booster program in Singapore, and the U S. B.
Andy Sassine: I will also provide some details regarding our manufacturing strategy as we prepare for the potential of emergency use authorization in Vietnam. Finally, I will provide some insights regarding our cash position and expected run rate. As you heard Joe mention, we had a very productive Q4 in 2021, including the completion of our clinical trial in Vietnam and encouraging human trial results in our ARC-154 booster program in Singapore and the U.S. of A.
Did you know we partnered our Ark 154 next generation Luna COVID-19 vaccine candidate in Vietnam with Vin bio care.
Andy Sassine: As you know, we partnered our ARC-154 Next Generation Lunar Code 19 vaccine candidate in Vietnam with VinBioCare. Vinn Biotech is a part of the Venn Group, which is one of Vietnam's largest corporations. FinBio is sponsoring and funding our Phase 1, 2, and 3 study in Vietnam targeting COVID-19 and variants of concern.
Vin biotech is the part of the <unk> group, which is one of Vietnam largest corporations.
<unk> bio is sponsoring and funding our phase 123 study in Vietnam targeting COVID-19, and variance of concern.
This partnership, including the trial and the collaboration around building a vaccine manufacturing facility in Hanoi.
Andy Sassine: This partnership, including the trial and the collaboration around building a vaccine manufacturing facility in Hanoi, resulted in significant cost savings of well over $200 million for Arcturus. Our technology transfer activities remain on track for the facility to become operational later this year, with a capacity of over 200 million doses annually. We are also continuing to work with other manufacturing partners to mature our global footprint, including Europe, Japan, and the U.S. of A.
Resulted in significant cost savings of well over $200 million for Arcturus.
Our technology transfer activities remain on track with a facility to become operational later this year with a capacity of over 200 million doses annually.
We are also continuing to work with other manufacturing partners to mature, our global footprint, including Europe , Japan, and the U S Survey.
Revenues from strategic alliances and collaboration for the fourth quarter of 2021 was $5.8 million.
Andy Sassine: Revenues from strategic alliances and collaboration for the fourth quarter of 2021 were $5.8 million, which increased sequentially by $3.4 million. This increase was due to the partial recognition of the $40 million payment we received from VinBioCare for the Manufacturing Technology Transfer Agreement. Total operating expenses for the fourth quarter were about $43 million, which declined approximately $10 million sequentially.
Which increased sequentially by $3 $4 million.
This increase was due to the partial recognition of the $40 million payment. We received from been bio care for the manufacturing technology transfer agreement.
Total operating expenses for the fourth quarter were about $43 million.
Which declined approximately $10 million sequentially.
This decline was primarily due to a sequential decline of $12 $8 million in research and development expenses for the fourth quarter of 2021.
Andy Sassine: This decline was primarily due to a sequential decline of $12.8 million in research and development expenses for the fourth quarter of 2021, which was $32.6 million. This decline was due to a reduction in manufacturing and clinical costs primarily associated with the Lunar Code 19 programs, including CMC requirements necessary for regulatory filing. The net loss for the fourth quarter of 2021 was approximately $39 million, or $1.47 per basic and diluted share. For the year, we reported a net loss of approximately $204 million, or $7.74 per basic and diluted share.
Which were $32 $6 million.
This decline was due to the reduction in manufacturing in the clinical cost primarily associated with the Luna COVID-19 program, including CMC requirements unnecessarily messy.
The theory for regulatory filings.
Net loss for the fourth quarter of 2021 with approximately 39 million.
Or $1.47 per basic and diluted share.
For the year, we reported a net loss of approximately $204 million or $7.74 per basic and diluted share.
Our cash balance at the end of the fourth quarter with $375 million and.
Andy Sassine: Our cash balance at the end of the fourth quarter was $370.5 million, and based on our current pipeline, our cash position is expected to be sufficient to support operations into late 2023. I will now pass the call back to Joe. Thank you. At this time, we will be conducting a question and answer session. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone to indicate your line is in the question... You may press star 2 if you'd like to remove your question from the... For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button.
And based on our current pipeline our cash position is expected to be sufficient to support operations into late 2023.
I will now pass the call back to Joe Hey, Thanks, Andy as we can see we've had another productive quarter advancing our pipeline of messenger RNA vaccines and therapeutics.
I guess now's the right time to turn.
They turn the time over back to you Kyle our operator to field questions.
Thank you at this time, we'll be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if you'd like to remove your question from the queue.
For participants using speaker equipment and may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.
Operator: One moment, please, while we call for. Our first question is from Yasmeen Rahimi with Piper Sandler. Please proceed with your question. Good afternoon, team, and thank you so much for the updates and congratulations on the emergency authorization being filed. So now with that behind you, can you maybe give us some color on when you should, when you would have the opportunity to present the data to us? And then, have you had a chance to review the data so far with your partners in biocare? Hey, great question, Yasmeen.
Okay.
Our first question is from just mean Rahimi with Piper Sandler. Please proceed with your question.
Good afternoon team and thank you so much for the update and congrats on the emergency authorization being filed.
Now with that behind you can you maybe give us some color on when you should when you would be at that have the opportunity to present the data that's a lot.
And then have you had a chance to review the data so far away here partner in Biochem.
Hey, Great question, you asked me and thanks for calling in you know as we realized that the data is owned by Vin bio care.
Joseph Payne: Thanks for calling in. You know, as we realize that the data is owned by VinBioCare. And so we want to acknowledge that we have had access to some clinical trial blinded data, but we have no access to unblinded data, and no access to any data of any kind on the phase 3b portion of the trial and beyond. So that's where we are. There may be opportunities in the future to share the data publicly, but after we get clearance from VinBioCare and after they share that data with the Vietnam Ministry of Health. Jill, maybe just to drill down, because this is a question we get, like, what's the timing process? Like, now that it has been filed, how long does it take for the review process?
And so we want to acknowledge that we have had access to some clinical trial blinded data, but we have we have no access to unblinded data and no access to any data of any kind on the phase III portion of the trial and beyond.
So that's where we are.
There may be opportunities in the future to share the data publicly but after we get clearance from Vin biochem and after they share that data with the Vietnam Ministry of health.
I'm, Joe maybe just to drill down because this is a question we got like what what's the timing process like now it has been filed how long does it take for their review process.
Jill: And then how many days or weeks can you wait before releasing it? So just kind of give us an idea of each of these steps before you share it with us. Well, now that the EUA has been submitted successfully, there is a period of time, of course, before that gets approved. We are guiding Q1, or this quarter, for the approval of the EUA. After at that point of approval, it presents the first opportunity to share additional data pertaining to this program. So I think those would be the near-term order of things. Just to make sure I understand, so let's say on March 30th, you get the UE; it's accepted.
And then how many days or weeks can you wait before releasing it so just kind of give us an idea of like each of these steps before you could share with us.
Well now that the E U.
He has been submitted successfully Ah theres a period of time of course before that gets approved we are guiding Q1 hour this quarter for the approval of the EUA.
After at at that point of approval.
You know that presents the first opportunity to share additional data pertaining to this program. So I think those would be the near term order of events.
Just to make sure I understand so let's say on March 30th you get do you eat except it is it just a matter of a few days as soon as it's accepted that you couldn't disclose the data to us.
Jill: Is it just a matter of a few days as soon as it's accepted that you can disclose the data to us? It's a fair and appropriate question, but that, you know, that would be ultimately under the responsibility of NBio. Of course, we'd like to work with them and share what's, Okay. Thank you. I'll jump back into Q for questions. Thanks.
It's a fair and appropriate question, but that you know that would be ultimately under the responsibility of been bio care of course, we'd like to work with them and share what's appropriate.
Got it thank you I'll jump back into queue for question.
Yeah.
Thanks, Yes.
Thank you. Our next question is from Brian Cheng with Cantor Fitzgerald. Please proceed with your question.
Operator: Thank you. Our next question is from Brian Chang with Cantor Fitzgerald. Please proceed with your, Hey, Joe. Hey, Andy.
Hey, Joe Hey, Andy Thanks for taking my question.
Operator: Thanks for taking my question, for a 154 program on, to have a presentation or any feedback from. Delegates, Delegates, Delegates. Delegates. Delegates. Delegates. If we're not able to reach all of the regulators... Hey, Brian, you're breaking in and out a little bit. Hello Jeff, can you hear me?
I Wonder if he fought program.
Yeah.
Okay station or any feedback from them.
Okay regulator.
Hey, Brian you're breaking in and out a little bit.
Can you hear me.
Yeah, Brian .
Joseph Payne: Yep, Brian, we're here. Please proceed. Please repeat the question. Okay. Yeah. So, can you provide some color on whether you have any feedback from other records, you know, boosters throughout? and think of all your data from the Declaration and Arnold Newman. Thank you.
Please proceed please.
Please repeat your question.
Yeah.
Can you provide some color on whether you have any feedback from either right.
Restaurant.
And I think its volume.
Data from.
A question for you to get that Green light booster.
Yeah. Thanks.
Sure. So I'm just going to repeat your question because it broke up a little bit, but I believe you're just trying to understand are there regulatory approval strategy for boosters.
Joseph Payne: Sure, so I'm just going to repeat your question because it got a little bit out of hand, but I believe you're just trying to understand the regulatory approval strategy for boosters. And we're in the process of engaging and aligning multiple regulatory authorities around the globe, frankly, and we're determining trial requirements in real time for that. So once we have that feedback, that information, and we have alignment there, then we'll be able to... Yeah, communicate. Okay, just one quick one on stockpiles. Will the Hanoi facility that's operated by Vingroup be operational by the time your EUA comes through? And can you comment on where you are in terms of stockpiles?
And we're in the process of engaging and aligning multiple regulatory authorities.
Around the globe, frankly, and we're determining trial requirements in real time for that so so once we have that feedback that information and we have alignment. There then we'll be able to.
Yeah communicate that.
Okay, just one quick one on stockpiling.
Joseph Payne: Because it seems that your R&D expenses for the quarter have come down a fair bit. Thanks. Sure. So, Vingroup is definitely funding the manufacturing facility, and I can comment that we are continuously assisting them in that effort. But the state-of-the-art facility is continuously being built.
Well, they're annoyed that subtlety, that's all for me and if I can be.
Be operational by the time, you EUA come through.
Can you comment on where you are in terms of stockpiling because it seems that your R&D expense this quarter have come down a fair bit.
Yes.
Sure So well Vin group is definitely funding the manufacturing facility and I can comment that we are continuously.
Joseph Payne: But with respect to specific updates on timing, it would be inappropriate for us to provide guidance for their facility that they're paying for and building. But I can comment that we're actively helping them and assisting them in the process, and it's progressing. In terms of a specific date of when it'll launch, we'd be looking to them to provide that guidance. It would just be inappropriate for us.
Continuously assisting them in that effort, but the the state of art. The state of the art facility is continuously being built but with respect to specific updates on timing it would be inappropriate for us to provide guidance for their facility that they're paying for in building, but I can comment that we're actively helping me.
And assisting them in the process and it's progressing in terms of a specific date of when it will launch we'd be looking to them to provide that guidance. It would just be inappropriate for us to do that.
Thanks, Joe.
And then Andy do you have another comment no I did I did provide some color in my commentary that you know the facility should be operational sometime later this year hopefully that'll help give you some guidance with respect to when they anticipate going into production.
Andy Sassine: And then, Andy, do you have another comment? No, I did provide some color in my commentary that, you know, the facility should be operational sometime later this year, so hopefully that'll help give you some guidance with respect to when they anticipate going into production. Great. Thanks, Andy.
Great. Thanks.
Thank you our question is from Seamus Fernandez with Guggenheim Securities. Please proceed with your question.
Operator: Thank you. Our next question is from Seamus Fernandez with Guggenheim Securities. Please proceed with your question. Mr. Fernandez, your line is now open.
Mr. Fernandez Your line is now open.
It looks like Mr. Fernandez has disconnected and our next question will come from Nick Abbott with Wells Fargo. Please proceed with your question.
Operator: It looks like Mr. Fernandez has disconnected, and our next question will come from Nick Abbott with Wells Fargo. Please proceed with your question. Terrific. Thank you very much. And yeah, congratulations to you and your partners on the EUA. So obviously, the approval would be for Prime Series.
Terrific. Thank you very much and congratulations to you and your partners on the E U.
Joseph Payne: And you mentioned, Joe, the global booster strategy, but presumably, VinBio has a booster strategy in mind for the local market. Can you talk about their plans for a booster approval strategy in Vietnam as well as perhaps adolescents and others? Yeah, Vietnam has vaccinated the majority of its population with approximately eight vaccines that have been approved locally.
So obviously the approval would be for Prime series, and and you mentioned, Joe the global boost our strategy, but presumably even bio has a booster strategy in mind.
For the local market can you talk about their plans for Boucher approvals trying to even Vietnam as well as perhaps.
Some of them.
Yeah that Vietnam is vaccinated the majority of their population with approximately eight vaccines that have been approved locally.
You know really it's been a concerted effort as you can appreciate this past.
Joseph Payne: They've really made a concerted effort, as you can appreciate, this past year or two to do so. But, you know, now it provides an opportunity to boost these folks, right? So we haven't disclosed any details with respect to our booster strategy in Vietnam, but we have shared that we're actively engaged with the Vietnam Ministry of Health in an EUA application process. And we've also disclosed that we're working with VinBioCare on the development of a manufacturing facility. So there are some indirect implications of that, but we haven't provided any direct guidance as to the timing of any sort of boosters being manufactured or distributed. Okay, thanks, Joe.
A year or two to do so but you know now it provides an opportunity to boost these folks right. So we haven't disclosed any details with respect to our booster strategy in Vietnam, but we have shared that we're actively engaged with the Vietnam Ministry of health in an EUA.
Application process and we've also disclosed that we're working with the <unk>.
<unk> on the menu the development of a manufacturing facility.
So there's some indirect implications of that but we haven't provided any direct guidance as to the timing of any sort of boosters being manufactured or distributed.
Okay. Thanks, Joe so.
Joseph Payne: So is it reasonable to assume that VinBioCare could be conducting a booster trial in Vietnam? Yes, what we've disclosed is that we are talking with multiple regulatory authorities, including the Vietnam Ministry of Health. You know, we have active trials with 154 in the U.S. and Singapore, and there are other regulatory agencies that we're working with, you know, communicating with, right, and determining trial requirements and trying to harmonize and get alignment there. Once we have that information collected, we'll be better suited.
Is it reasonable to assume that didn't buy it could be.
Conducting a booster trial in Vietnam.
Ah Yes, we what we've disclosed is that we are talking with multiple regulatory authorities, including the Vietnam Ministry of health.
We have active trials with $1 54 in the U S and Singapore and there's no other regulatory agencies that were you know.
Communicating with right and determining trial requirements and trying to harmonize and get alignment. There. Once we have that information collected will will be better suited to communicate it.
We plan on somebody named more clarity Oh, Andy Andy has a comment too yeah. We we plan on providing more clarity for our booster strategy. You know later on this quarter. So.
Joseph Payne: We plan on providing more clarity for our booster strategy later this quarter, so stay tuned. And then, you know, Joe, you've mentioned the fact that the data is sort of owned by the Phase 3 data is owned by BINBIO. What is the process for you to share that data with potential partners outside of the industry?
Stay tuned yeah.
Okay.
And then you know Joe you've mentioned the fact that the data sort of owned by the phase III data is owned by even by.
What is the process you to share that data with.
Potential partners outside of Vietnam.
Well, we we haven't seen any of the unblinded or blinded data pertaining to the phase III b or beyond but we had the opportunity to.
Joseph Payne: Well, we haven't seen any of the unblinded or blinded data pertaining to phase 3B or beyond, but we've had the opportunity to see some of the blinded data for the earlier clinical trials that remain to be encouraging, and we have the freedom to share that with potential partners, for example. Is that what you're asking? Yeah, yeah, I guess I mean, you know, with them owning the data, obviously, that, you know, you don't perhaps have the free hand that you would otherwise to share the data.
So it's encouraging that you can so can you update us on you know, perhaps discussions with outside of Vietnam with potential partners.
Joseph Payne: So it's encouraging that you can. So can you update us on, you know, perhaps discussions outside of Vietnam with potential partners? Well, it's challenging always to give specific guidance on that. You know, Arcturus has always been active in its, you know, strategic discussions with potential partners, right? But we don't provide specific guidance. Okay, thanks. I'll go back in the queue.
Well, if it's challenging always to give specific guidance on that they arcturus has always been active and it's a strategic discussions with potential partners right, but we don't provide provide specific guidance on that.
Okay. Thanks, I'll go back in the queue. Thank you.
Thanks, Nick appreciate you calling in.
Operator: Thank you. Thanks, Nick. Appreciate you calling in. Thank you. Our next question is from Kumar Rajat with Brookline. Please proceed with your question. Hi, I'm Shubhendu Forkumar.
Thank you. Our next question is from Kumar Raw dropped with Brookline. Please proceed with your question.
Hi, I'm sure window for Kumar.
So with regards to the only thing.
Operator: So with regard to the Omicron trial, could you provide us some color on the ongoing enrollments in Europe? And also, do you think the current unfortunate war situation that is ongoing there might impact enrollments? And how are you preparing for it?
Provide us some color on the ongoing enrollment in Europe and also do you think the current unfortunate a worst situation, but the long run there might impact enrollments and how are you preparing for it.
Are you speaking to the enrollment of our therapeutics programs, our rare disease programs are for OTC deficiency.
Unknown Attendee: Are you speaking about the enrollment in our therapeutics programs or RAID disease programs or for OTC deficiency? Yes, right. Oh, yes.
Yes, right, Okay, yes, well what's unique about this phase two trial is that it's a multi dose trial. So it's because of that the participants are looking to to have something significant happened right potentially are functionally.
Joseph Payne: Well, what's unique about this phase two trial is that it's a multi-dose trial. So because of that, the participants are looking to have something significant happen, right? Potentially or functionally curing their disease because it's a multiple dose trial. So it's easier to recruit people for that reason, at least that's our thinking.
During their disease, because it's a multiple dose trial. So it's easier to recruit people for that reason at least that's our thinking at this point. We've we've have three Ah I think it's the United Kingdom in Belgium, and Spain.
Joseph Payne: We've got three, I think it's the United Kingdom, Belgium, and Spain; we're looking to add additional countries, as we've mentioned in the guidance. As long as there are no surprise waves of COVID that can interrupt things, we should be okay with respect. So that's what we're guiding, and we're still well on track, for sharing some interim clinical data for our OTC program in the second half of this year Okay, great.
We're looking to add additional countries as we've mentioned in the guidance as long so surprising waves of Covid that can interrupt things, we should be okay with respect to recruitment.
So that's what we're guiding and we're still well on track for.
For sharing some in term.
Clinical data for our OTC program in the second half of this year.
Okay. So you don't have the the garden.
Joseph Payne: So we don't think the current war situation will spill over to impact the recruitment process now. Okay, thanks. Yeah. So we don't have any recruitment going on in Ukraine or our neighboring countries or anything like that.
Lord situations will spill over to impacting the.
A recruitment process no. Okay. Thanks, yeah. So we don't have any recruitment going on in Ukraine or are our neighboring countries or anything like that so we're fine there excellent. Okay. Thank you.
Joseph Payne: So we're fine there. Excellent. Okay. Thank you. With regard to the CISCID fibrosis program, could you indicate what remains to be done for the CTA applications? Yeah, so we're in the process of doing all the, you know, the talk studies, the IND, or, in this case, the CTA enabling studies for that program. And now we have tighter guidance there for Q3 for a CTA to be filed. So we're just in the final steps that we've gone through previously in other programs, in terms of just establishing that, you know, the appropriate.
With reduction of cystic fibrosis program could you indicate what remains to be done for the Cta applications.
Yeah. So we're in the process of doing all the you know the Tox studies, the IMD or the in this case, the Cta, enabling studies for that program.
Now we have tighter guidance there for Q3 for a cta to be filed so we're just in the final.
Steps that we've gone through previously in other programs.
In terms of just establishing that you know the the appropriate.
The supportive toxicology data that's required for these submissions. So we're we feel very comfortable and confident that we can that we can meet that that our Q3.
Joseph Payne: The support of toxicology data that is required for these submissions. So we feel very comfortable and confident that we can meet that Q3, of Guidance for Filing the CTA for Cystic Fibrosis. But there's nothing atypical about the database.
Guidance for filing the Cta for for for cystic fibrosis, but theres nothing atypical about the data being collected.
Okay, Great sounds great. Thank you so much for taking my questions.
Joseph Payne: Okay, great. Sounds great. Thank you so much for taking my question. Yeah, of course. Thank you for calling.
Yeah of course, thank you for calling in.
Thank you. Our next question is from Seamus Fernandez with Guggenheim. Please proceed with your question.
Operator: Thank you. Our next question is from Seamus Fernandez with Guggenheim. Please proceed with your question. Hi guys, this is Evan Wang for Seamus.
Hi, guys and weighing for Seamus. Thanks for taking my question and congrats on the year submission.
Operator: Thanks for taking the question and congrats on the UA submission. Sorry, I got a little disconnected earlier, but, you know... Maybe this was already asked, but can you talk about the next event within the ARC154 Vietnam Trail, you know, and when, I guess, with an emphasis on the Phase 3B and 3C programs, you know, when maybe those programs or portions will be complete, and when, maybe at the perfect time, or when BioArcturus may share data? Another question is, I guess, how confident is Arcturus in bringing forward ARC-154 in the ex-Vietnam market?
Sorry, I got disconnected earlier.
So maybe this was already asked but can you talk about next events within the Ars one five for al and one I guess, what's the emphasis on the phase three D and three she programs.
One maybe one when those programs are are portions be complete and when maybe an appropriate time, we're getting by our arcturus may share data.
Another question is I guess, how confident are curious and bringing forward. Our one five for an ex U S markets.
And I have a follow up.
Joseph Payne: and as a follow-up. Okay, well, with respect to the timing of what's the next milestones in Vietnam, we've just filed an EUA application, right, or then BioCare did it on our behalf. And so, you know, we're looking to have that approved. Our guidance that we're providing is the approval of the EUA in the first quarter of this year, so by sometime next month.
Okay, well with respect to timing of.
Joseph Payne: And then looking beyond that, the Phase 3B data or efficacy data, that is expected to be included or anticipated to be included in some sort of full approval application that will be later this year. Once we have that bolted on with an EUA approval, that can be combined for a full approval application. And we haven't provided tight guidance, except just later this year, as soon as we can, of course. With respect to what other countries will honor and respect in emergency use approval and or full approval from Vietnam, that's a great question; we're looking into that, of course, whether it's other Southeast Asian countries or developing nations or, you know, Vietnam is well-networked with the WHO and all those nations as well.
What's next milestones in Vietnam, We've we've just filed an EUA application right or are in biochem did in our behalf and so you know we're looking to have that approved our guidance that we're providing is the approval of the UAE and in the first quarter of this year. So by the sometime next month.
And then looking beyond that the phase III <unk> data or efficacy data that is expected to be included are anticipated to be included in some sort of full approval application that'll be later this year.
Once once we have that bolted on with an EUA approval that can be combined for a full approval application.
And we haven't provided tight guidance, except just later this year as soon as we can of course.
With respect to what other countries will honor and respect an emergency use approval and or full approval from Vietnam. That's a great question, we're looking into that of course.
Whether it's other southeast Asian countries are developing nations or or.
Our for Vietnam, as well networked with the W. H O and all all those nations as well. So we are looking into those opportunities.
And then we're developing a a booster regulatory strategy with multiple regulatory agencies globally, not only with Vietnam.
Joseph Payne: So we're looking into those opportunities. And then we're developing a booster regulatory strategy with multiple regulatory agencies globally, not only with Vietnam but with, you know, other countries. We're collecting information to try to gain alignment with our regulatory strategy for the booster label as well. Did that address your question, Chena?
But with other we're collecting information to try to to gain alignment with our regulatory strategy for the booster.
The label as well.
Did that address your question Seamus.
Yeah. That's helpful and can you talk on the OTC program. Another phase two has been authorized since I think mid last year, how is patient identification.
Operator: [inaudible] Yeah, that's helpful. And you talk about the OTC program. I know that phase two has been authorized. I think mid last year. How has patient identified cases, efforts banned since authorization, and how is the company prioritizing enrollment in the Phase 1B and the Phase 2 studies? Oh, so this is referring to the OTC Division C program.
It's been since its authorization and how is the company prioritizing enrollment in the phase one being a phase II study.
Oh. So this is referring to the OTC deficiency program.
Joseph Payne: And so we're starting to, as you can understand, now that COVID is being controlled in many of these countries where we're doing trials, we're starting to recapture momentum and success on the recruitment side. And so we've provided some guidance there with not only Phase 1B, we're starting to reinvigorate recruitment efforts and screening efforts for the Phase 1B trial, but also in Phase 2 in Europe, in the United Kingdom, Spain, and Belgium, and some additional countries that we're going to be adding.
And and so we were starting to.
As you can understand now that Covid is being controlled in many of these countries, where we're doing trials, we're starting to recapture momentum and success on the recruitment side of things and so we've provided some guidance there with not only phase one b, we're starting to.
Reinvigorate.
Recruitment efforts in screening efforts on the phase <unk> trial, but also in phase two in Europe , and in the United Kingdom, Spain, and Belgium, and some additional countries that we guided towards that we're going to be adding so I think.
Joseph Payne: So I think we're well, not just I think we're guiding as a company, as a corporation that we are going to be having some interim data in the second half of this year. I hope that will be biological proof of concept for the OTC program.
Well not just I think we're guiding.
As a company as a corporation that we are going to be having some interim data.
In the second half of this year.
I hope that will be biological proof of concept for the OTC program.
Great. Thanks.
Thank you. Thanks. Our next our next question is from Steve a seat house with Raymond James. Please proceed with your question.
Operator: Thank you. Our next question is from Steve Seedhouse with Raymond James. I know this is Ryan Decheron on behalf of Steve Speedhouse.
I know this is Ryan deschner on for Steve.
Okay wanted to ask you guys.
Operator: I wanted to ask you guys, hi there, is a vaccine efficacy event, event-based study for O2-1 still feasible or a possibility in Singapore given the high primary vaccination rate there? And would you consider event-based studies in other potential geographies at this point? No, no, I think placebo-controlled vaccine efficacy trials are, I think, a trial design of the past going forward, but with respect to, you know, that question is a complicated one because it depends on the regulatory agency or the country we're talking to.
Sure.
Is it the vaccine efficacy event event based study for 021.
Still feasible or or possibility in Singapore, giving the.
Primary vaccination right there and would you consider event based studies and other potential geographies at this point.
No no I think.
For our placebo controlled vaccine efficacy trials I think R. R.
Ah trial design of the past going forward.
But with respect to you know.
It is that that question is a complicated one because it depends on the regulatory agency or the country were talking to them.
So so you know we have we've completed a vaccine efficacy trial for $1 54.
Joseph Payne: So, you know, we have, we've completed a vaccine efficacy trial for 154. But with respect to O21, we've partnered with a global entity that's funding any sort of late-stage clinical trial efforts there, and we'll be looking to them with respect to the phase three trial and the respective design of that trial. Okay, thank you very much.
But oh.
With respect to O. Two one we're looking at we partnered that with a global entity. That's funding any sort of late stage clinical trial efforts, there and we will be looking to them with respect to the the phase III trial and the respective design of that trial.
Okay. Thank you very much.
Yeah.
Yeah.
Thank you. Our next question is from Ed Arce with H C. Wainwright. Please proceed with your question.
Operator: Thank you. Our next question is from Ed Arce with HC Wainwright. Please proceed with your. Hi, good afternoon everyone. Congratulations on all the progress this quarter. This is Thomas Yip asking a couple of questions for Ed. So, given that data for your 154 vaccine program, it sounds like it's mostly in the hands of BIMBIO, and, as you just pointed out, O2-1 development is still ongoing with a global entity. Can you discuss what geographical area this upcoming study will be in? And then I have one more question. The geographical area for which study, for 154?
Hi, good afternoon, everyone. Congratulations on all the progress this quarter. This is Thomas Yip asking a couple questions for Ed.
Operator: For 021, we know 154 is primarily in Vietnam. Yeah, the 021 study, all sort of future updates with respect to the clinical trial design and location of that study are going to be provided by the global entity. And so we'll be looking to them for that. 154 is more advanced, of course; we announced today an emergency use approval filing in Vietnam. So that one's closer to reaching approval.
So given that data for a four for 154 vaccine program and it sounds like.
It's mostly in the hands so it's been bio.
Our and Ah Stewart, just pointed out to one department store aren't going where for a global entity can you discuss what geographical area with this upcoming study be and Oh, and then I have one more question.
The geographical area for which study for 1544021, we didn't know 154 as a primarily in Vietnam.
Yeah, the O to O two one study that's.
I'll sort of future updates with respect to the clinical trial design and location of that study is going to be provided by the global entity and so we'll be looking to them for that 154. It is more advanced of course, we announced today an emergency use approval.
Our filing in Vietnam, so that one's closer to.
Reaching approval.
But.
That's where our preliminary focus is going to be on with respect to our vaccine franchise will be around 154.
Joseph Payne: But, you know, that's where our, you know, preliminary focus is going to be on with respect to our vaccine franchise, which will be around 154. Understandable, and then perhaps one question about the OTC program: do you outline the interim data for the second half this year, still on target? Can you describe what kind of data we should expect? Is it safety data, or perhaps some efficacy data? Yeah, I hope all of the above, right?
Understood and then perhaps one question about the OTC program.
You outlined the interim data in second half. This year are still on target can you describe what kind of played out should we expect a safety data or perhaps some efficacy data.
Yeah, I I hope all of the above right I'll always guided us in term data in a subset of the participants of course, we're gonna be looking not only at safety.
Joseph Payne: All we've guided is interim data in a subset of the participants. Of course, we're going to be looking not only at safety in OTC Division patients, but there are multiple biomarkers associated with that disease, including ammonia in the plasma and erotic acid in the urine, and urea itself, or ureagenesis, can be tracked. This is a urea cycle disorder.
In OTC deficient patients, but theres multiple biomarkers associated with that does that disease, including ammonia in the plasma and erotic acid in the urine and urea itself. Our urea Genesis can be tracked this is a urea cycle disorder. So.
Joseph Payne: So if any of that data proves out the concept, we'll be excited to share it, but interim data is what we've guided for for the second half of this year. Understandable. Thank you so much again for the questions, and we look forward to the EUA decision next month. Yeah, thanks, Thomas. And say hi to Ed.
If any of that data.
<unk> out the concept will be excited to share it but interim data is what we've guided for.
For the second half of this year.
Understood. Thank you so much again for the kind of questions and we look forward to their decision.
This isn't a next month.
Yeah, Thanks, Thomas and say how to Ed.
Further.
Yeah.
Thank you. Our next question is from yachts mean Rahim meet with Piper Sandler. Please proceed with your question.
Operator: Thank you. Our next question is from Yasmeen Rahimi with Piper Sandler. Please proceed with your question. Hey team, just thanks for taking my follow-up question. This is directed to Andy. Andy, can you comment on whether VennBioCare has scaled up manufacturing now that they have seen the data and files? Do you see those activities being ramped up?
Hey, Tim just to thanks, and thanks for taking my follow up question. This is directed to Andy Andy can you comment whether been biochem.
Scaled up manufacturing now as they have seen the data and file them.
Do you see those activities to being ramped up thank you for taking my question.
No thanks for coming.
Andy Sassine: Thank you for taking my question. No, thanks for coming back on and asking that question. As we alluded to in our commentary, we had indicated that we needed to get CMC approval and manufacturers of, you know, some of these runs, so you would have to assume that, you know, we're trying to remain consistent here in the U.S. with the 154 production and also in Europe with our partners. And so hopefully, as we alluded to, we expect the facility in Vietnam to be able to start production later this year. We haven't been able to get specific guidance as to when this year, but they're on that path to hopefully getting it done.
Coming back on in asking a question that we alluded to in our commentary.
You had indicated that we needed to get our CMC approval and manufacturer.
You know some of these run so you would have to assume that you know we're trying to remain consistent here in the U S. With the one five for production and also in Europe with our partners.
So hopefully you know as.
We alluded to we expect the facility in Vietnam to be you know.
Able to start production later this year, we haven't been able to get specific guidance as to when this year, but they're on that path to hopefully getting it done and.
Andy Sassine: And we continue to work very closely with them in sharing the technology transfer information with their team. Thank you, Andy. Thanks, Yasmeen. We have reached the end of the question and answer session, and I will now turn the call over to Joseph Payne, President and CEO, for closing remarks. Just thanks everyone for calling in, and we look forward to reconnecting either at a conference or, as always, you can reach out to IR, and we can address any follow-up questions you have if you couldn't think of it at this time. So it's bye for now, until we meet again, bye. This concludes today's conference, and you may disconnect your lines at this time. Thank you for participating. Yigal Nochomovitz
We continue to work very closely with them and sharing of the technology transfer.
Information with their team.
Thank you Andy.
Thanks, Yes.
We have reached the end of the question and answer session and I will now turn the call over to Joseph Payne, President and CEO for closing remarks.
Just thanks, everyone for calling in.
We look forward to reconnecting either at a conference or as always you can reach out to IR and we can address any follow up questions. You have if you couldn't think of it at this time.
So its bye for now until we meet again bye.
This concludes today's conference and you may disconnect. Your lines at this time. Thank you for your participation.
[music].
Jill: Thank you for joining Arcturus' quarterly call today. Before we begin, I would just like to acknowledge that today is National Rare Disease Day, February 28th, and given that two of our pipeline programs are rare diseases. You know, that is OTC deficiency, a rare liver disease, and cystic fibrosis, a rare lung-centered disease.