Q3 2022 Arcturus Therapeutics Holdings Inc Earnings Call
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Good day, ladies and gentlemen, and welcome to the Arcturus Therapeutics third quarter 2022 earnings call. Today's conference is being recorded at this time I'd like to turn the conference over to Kyle Good Stat senior analyst or Investor Public Relations. Please go ahead.
Thank you Keith good afternoon, and welcome to Arcturus Therapeutics third quarter 2022 financial update and pipeline progress call. Thank you all for joining US today's call will be led by Joseph Payne, our president and CEO and Andy Sassine, Our CFO , Dr pad cheaper cooler, our CSO and C O O will join in for.
The Q&A session before.
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 statements.
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 forms 10-Q, and 10-K filed with the SEC.
In addition, any forward looking statements represent our views only as of the date such statements are made November nine 2022.
Tourist specifically disclaims any obligation to update such statements to reflect future information events or circumstances and with that I'll now turn the call over to Joe.
Okay. Thank you and good afternoon to all and thank you for joining Arcturus is Q3 quarterly call.
The recent period has been characterized by remarkable progress we've made both with our pipeline and also in completing transformational business development agreements with CSL and BARDA.
I'll begin with our recently announced collaboration with CSL.
I want to first express my gratitude to the entire team here at Arcturus that worked tirelessly on the steel, particularly the deal team led by Lance Corrado, our Chief legal officer, and Kevin Scull, who leads our business development efforts. They all did an exceptional job. Indeed, there is an extraordinary story behind every.
<unk> extraordinary deal. So thank you to the team many of which are listening to the call.
This collaboration with CSL is designed to develop and commercialize self amplifying mrna vaccines targeting COVID-19, influenza three additional pathogens and pandemic preparedness.
This broad strategic collaboration will drive the development manufacture and global commercialization of novel self amplifying mrna based vaccines.
This was a transformative deal for Arcturus, both from a financial perspective, as well as in positioning our company to become a leader in the development and delivery of mrna vaccines and therapeutics.
CSL secure us as one of the top two companies in the multiple billion dollar influenza vaccine market.
And they bring profound capabilities, especially related to advanced vaccine manufacturing development distribution and commercialization.
The collaboration combined CSL secures as well established global vaccine commercial and manufacturing infrastructure with our tourists as manufacturing expertise and innovative star self amplifying mrna vaccine.
And lunar delivery platform technologies.
Together, we will focus on the development of self amplifying mrna vaccines targeting <unk>.
COVID-19 influenza three additional defined respiratory infectious disease vaccines and pandemic preparedness.
And we look forward to providing continued updates on our plans and progress in the coming months.
The agreement will become effective upon the expiration of the Hart Scott Rodino waiting period.
Andy will provide further details about the collaboration but I'll briefly mention some highlights arcturus will receive $200 million upfront.
Up to $4 3 billion in potential development and commercial milestones.
40% profit sharing for COVID-19 vaccines.
And up to double digit royalties for influenza and three additional defined respiratory infectious disease vaccines.
These are very meaningful figures and we expect this deal to provide meaningful funding to support the development of our pipeline over the coming years.
With the CSL partnership in place, we are prioritizing, our regulatory and clinical efforts toward larger commercial markets.
CSL is responsible for providing guidance and updates pertaining to <unk> $1 54, and any of its future derivatives.
Now onto the BARDA agreement.
This is our second recent external agreement with the biomedical advanced research and development authority or BARDA.
This transaction provided Arcturus within award valued at up to $63 2 million over three years.
The award will support preclinical manufacturing non clinical safety studies, along with development and regulatory support for Arcturus has self amplifying mrna vaccine platform technology for rapid pandemic influenza response through phase one clinical studies.
Our low dose lyophilize vaccines are preferable when stockpiling footprint in pandemic preparedness are taken into consideration.
Self amplifying mrna vaccines have the potential to provide safe and effective protection against disease with the specific advantage of rapid scale up lower doses.
And easier transport and storage.
These are quality is essential to our rapid response against pandemic influenza and are consistent with the strategic objectives of the U S government's national strategy for pandemic influenza.
We believe that this highly sought after.
BARDA Award provides further validation for our technology and its promise to deliver important new vaccines and medicines.
This agreement with BARDA establishes a meaningful contractual relationship with the U S government.
So when the next pandemic occurs heaven forbid Arcturus may have a more streamlined process to accessing pandemic related government funding.
I also want to acknowledge that the CSL collaboration agreement allows for arcturus to perform its obligations under the BARDA contract.
Now moving to <unk> 10.
This is our therapeutic candidate for ornithine transcribe families deficiency or OTC deficiency.
Our therapeutic candidate aims to address the deficient OTC enzyme in the liver of individuals living with this disease.
<unk> 10 has the potential to restore urea cycle activity prevent or slow the progression of neurological damage and potentially expand dietary options and improve on the quality of life for people living with this condition.
All subjects in our phase one b single ascending dose study have completed dosing.
Including the cohort dosed at 0.4 milligrams per kilogram without requiring steroid treatment.
We continue to advance our Cta 10 in a phase two randomized double blind placebo controlled nested single and multiple ascending dose clinical trial.
Whose design will enrolled 24 adolescence and adults living with this disease.
The study is being executed in multiple European countries.
The participating sites are working with several thousand identified patients through the pre screening process with dosing beginning this quarter.
Next year, the company will strategically share in term RCT 810 clinical data.
Simultaneously with the announcement of new additional liver therapeutic programs.
So we look forward.
Look forward to that.
Now moving onto our cystic fibrosis program.
Continued to progress the necessary preclinical and non clinical studies to enable <unk> 32 to move to the clinic.
<unk> 32.
Is our inhaled messenger RNA therapeutic candidate for cystic fibrosis.
New preclinical data was presented and well received at the 2022, North American Cystic fibrosis Conference last week and we included some of that data in our press release today.
The new data slides presented that the NAC FC are readily available on our website. If you click on the publications tab.
These data provide further support for the therapeutic potential of <unk> 32.
Three critical steps for an inhaled messenger RNA are required to be successful.
Delivery protein expression and functional restoration.
So the first critical step is delivery getting that messenger RNA.
To where it needs to be and these new preclinical data demonstrated effective delivery of messenger RNA to bronchial and tracheal epithelium cells, even in the presence of CF sputum or mucus.
The successful delivery data are attributed to our tourist as proprietary lunar technology.
We have previously shared successful inhaled delivery data in multiple animal models, including healthy mice rats, ferrets and primates.
These new data however were collected utilizing a well established well established C F Ferret model.
We're in these animals present mucus that coats the airway epithelium cells in their lungs.
The observed effective delivery of messenger RNA and this CF Ferret model is noteworthy.
Onto the second critical step of protein expression.
Treated human bronchial epithelial cells from CF donors.
They were treat the cells were treated with a <unk> 32 in vitro and demonstrated robust expression of mature see FTR protein at levels comparable to control non CF, a wild type donors.
As for the third critical step of functional restoration additional in vitro data demonstrated robust restoration of see FTR transporter activity.
Bronchial epithelial cells.
Obtained from human CF donors were treated with <unk> 32, and after the treatment we observed a significant increase in chloride ion current up to 70% restoration.
Compared to control <unk> bronchial epithelial epithelium cells obtained from non CF donors so to summarize.
We've observed successful delivery of mrna to tracheal bronchial epithelial cells in the presence of mucus and our CF Ferret model.
We also observed robust in vitro expression of see FTR protein alongside functional restoration of chloride ion current all comparable to controls.
All of these are important milestones for the <unk> 32 program.
We believe that this therapeutic candidate <unk> hundred 32 may bring significant benefits to individuals living with cystic fibrosis.
<unk> those unaided by currently available treatments.
We continue to anticipate submission of a clinical trial application or Cta for <unk> 32 by year end.
I will now pass the call onto Andy Sassine, our CFO to provide financial updates.
Thank you Joe and good afternoon, everyone.
The press release.
Issued earlier today includes financial statements for the third quarter of 2022.
And provides a summary and analysis of year over year and sequential financial performance.
Please reference our 10-Q for more details on our financial performance.
I'll begin with a summary of the CSL agreement, we signed last week.
Under the terms of the agreement <unk> will receive $200 million upfront.
And is eligible to receive over one 3 billion.
<unk> development milestone and over $3 billion in commercial milestone.
In addition, the company is eligible to receive a 40% net profit share for COVID-19 vaccine product.
Hope to double digit royalties for vaccines against flu pandemic preparedness and three other respiratory pathogens.
This is a 60 40 profit sharing agreement on COVID-19 vaccine product.
With respect to the program cost.
The milestone will cover all of our expenses going forward.
We provided to yourself from R&D credits, which was spread out over five years and will likely be applied to the flu and other programs.
ESL transaction is subject to filing under the Hart Scott Rodino Antitrust Act.
The HSR filings have been made by both parties.
We are in the waiting period.
Assuming the transaction closes.
Have you received the 200 million upfront payment.
We expect that our true will be funded with three year based on our current pipeline and assuming no revenues from any product sale.
This assumed the milestone will cover all of our Covid program call.
In evaluating new collaboration we take a comprehensive view of new potential agreement and how they align with our existing agreements to ensure that our plans support our longer term strategy to advance our pipeline and create shareholder value.
Last week, then bio care and our true mutually terminated our mrna license and COVID-19 supply agreement and entered into a study support agreement.
<unk> does not strategically fit in with the combined CSL Arcturus global manufacturing plan.
However, we continue to work closely with <unk> in Vietnam to prepare the clinical data collected.
Regulatory approval in certain countries.
I will now provide a quick summary of our financial results.
We reported revenues of $13 4 million for the third quarter of 2022.
Third to revenues of $2 4 million in the three months ended September 32021.
The increase in revenues was predominantly driven by the bin bin Biochar agreement.
We reported total operating expenses of $50 2 million during the third quarter of 2022 compared to operating expenses of $56 3 million.
Three months ended September 32021.
The decline in operating expenses was primarily due to lower manufacturing costs.
Finally, we reported a net loss of approximately $35 3 million or $1 33 per basic and diluted share for the third quarter of 2022.
Compared to a net loss of $54 1 million or $2.05 per basic and diluted share.
For the three months ended September 30 of 2021.
As Joe mentioned earlier, we also signed an agreement with BARDA that will provide up to $53 million in.
Funding to the company over the next three years.
Supported by these two agreements.
Truth is expected to be in a very strong financial position over the next few years.
As discussed the company is expecting to receive $200 million.
The CSO upon expiration of the waiting period under the Hart Scott Rodino.
Antitrust improvement Act.
We believe that our company has the resources needed to achieve multiple value, creating milestone for a vaccine and therapeutic program.
I will now pass the call back to Joe.
Okay. Thanks, Andy we are highly encouraged about the potential of our mrna vaccine and therapeutic pipeline.
Very pleased with our recent progress this.
This recent period has been highlighted by the closing of meaningful agreements and continued advancement of our pipeline of mrna vaccines and therapeutics.
We believe our agreement with CSL secures opens enormous opportunities for our company and we're excited.
To continue to execute on our mission to bring meaningful new treatments to patients. While also rewarding our shareholders. We look forward to providing you with future updates on our progress and I'll now turn the call back to the operator for questions.
Thank you, ladies and gentlemen, if you'd like to ask a question may do so by pressing star one on your telephone keypad. Please make sure the mute function on your phone is turned off so the signal can be read by our equipment.
Darwin for questions, we'll pause a moment to assemble the phone queue.
We'll take our first question from Yasmin Rahimi with Piper Sandler. Please go ahead.
Hi team. This is Lauren on for yes, just two quick questions for you first can you provide some color on the timing for the interim analysis what exactly.
We will be included in that interim and then second how far are you away from filing the CF program in the U S and what's left in regards to the Cta.
Sure. So the first question are you, referring to <unk> hundred 54, or <unk> 10.
The programmer.
Okay, <unk>, yes, yes.
Yeah, we indicated that we're going to strategically share that data simultaneously or concurrently with the announcement of our of our new programs new liver therapeutic programs.
And so that's going to be sometime in 2023 of.
Of course, we are.
Are disappointed with the progress of of our recruitment this year.
However, we fully intend not to repeat.
Some of those challenges that we have incurred this year and we look forward to.
Getting the data as soon as we can next year, but what's important to understand is there's going to be a strategic communication.
The communicating the data the interim data that will be concurrent or simultaneous to the disclosure or declaration of our announcement of additional labor therapeutic programs.
And the second question is around the Cta.
Now there's very there's.
For CF Theres very little left remaining to do.
We indicated that we remain on track for a filing of that Cta. This year. This quarter, so that theres not many weeks left so anything to add pad with respect to the final remaining elements.
The application process established the drafting.
All of the work has been done and we're just in the process of just five of.
Of drafting the filing.
That's it okay. Thank you so much.
Thanks, Yes.
We will take our next question from.
Thank you Ms Hernandez with Guggenheim. Please go ahead.
Thanks for the questions guys. So.
Can you just.
Maybe help us understand how are you.
It sounds like most of the communications for the Covid program are going to be rolling.
From CSL.
Just hoping to get a better understanding of how you guys are.
Looking towards that progress.
In that process.
How the reimbursement for R&D expenses, given the sort of 40%.
<unk> sharing agreement, how that's going to work I, just wanted to get a better sense of.
What the.
The.
Timeline for communication around the 154 program.
Might be and what kind of.
Is written into the contract for you guys to at least influence that.
On the margin and then the second question.
At the.
The R&D event, that's yes L posted recently.
You did talk about their own.
Ah self amplifying mrna program.
Just wondering if you guys have rights to that program.
Should that program advance or Yep Yep.
If your own influenza program and theirs.
It may in fact be competing.
Sure sure. There's a few questions there I'll address them one at a time.
First of all yes. It is correct that CSL is responsible for providing guidance and updates pertaining to <unk> 54 in any of its future derivatives.
But we are actively supporting them and working with them on the clinical efforts and regulatory efforts.
With respect to the <unk>.
Question on any sort of CSL fluid development programs, if if CSL uses arcturus technology or its platform our manufacturing knowhow in any way that will trigger the financials for that program, meaning the associated milestones and royalties.
Now there was a question about the 40 60 or 60 40 ratio I don't know if you wanted to elaborate on that.
And I can turn that to.
To Andy but did I address the the two major questions.
Yes, you did thank you.
Okay.
Okay.
Okay.
We will take our next question from Thiago <unk> with Citi. Please go ahead.
Okay.
Hi, John Andy how are you.
A few questions here.
Some sort of forward looking and I may not.
Have all the answers, obviously, but let's see.
Program.
Or does the.
And the vision target profile. There I mean are you thinking this is going to be a daily or weekly or monthly inhaled I know it's very early.
You have a hypothesis or a vision.
For what kind of value.
Yeah. So.
What we understand is that we'll be able to express the protein see FTR.
Shortly after administration.
But what we but we also recognize is that protein does not have a very long half life. However, the effect the functional effect of that protein may.
Extend the durability of it and that's still being determined by the field.
So how often these treatments will be.
As speculative at this point, we're anticipating weekly, but we do not know that detail until we collect the data.
Okay got it and then also a clinical question on OTC.
You know in terms of what you want us to be on ammonia reduction so cheap.
What is your threshold.
Threshold, there that youre looking to achieve.
Yes, thankfully the field as is.
Maturing its understanding of what sort of restoration of of the enzyme is required for normal function and we've seen that in an analysis and publications that have been shared that it ranges from 4% to 16%. So if theres, 4% protein restoration.
That that is viewed as preventing death, which would be very meaningful in this disease, especially in young males.
And then all the way up to 16% protein restoration would be required for for or expected to establish a normality in general.
Okay got it.
And then I don't know if you can answer this one it might be more of a yes no question, but I think in the CSO press release, they mentioned that they're starting a program with their own budgets.
Vaccine next year.
Correct.
Sure.
Your blue.
Flu vaccine that they might work on parallel program or backup program or.
How does that all work.
Yes, I think it's best to say that we're combining.
<unk>.
Our efforts on this program.
If it whatever comes out of it if if.
Combined or one of the either programs and successful as long as it uses.
A portion of our technology or manufacturing Knowhow, it will trigger the full financials of milestones and subsequent royalty.
But with respect to.
Which of these programs are ultimately going to be selected to move forward in advanced development.
We refer you to CSL.
Yeah.
Okay. Thank you.
Okay.
Thank you.
Thank you.
We will take our next question from Pete <unk>.
Louis with Cantor Fitzgerald. Please go ahead.
Hi, Joe and Andy.
Hope all is well.
I have one quick question on the OTC program.
Yes.
Okay.
When you think about the patient population.
The heterogeneity in terms of presentation, the neonatal late onset OTC as well as other programs in development such as gene therapies.
<unk> achieved the target product profile you hope for.
And where do you sort of see this fitting into the evolving treatment landscape.
Yes, great question.
There are significant advantages to the arcturus therapeutic candidate for OTC being a messenger RNA therapeutic it's a transient effect, which means that any side effects that are observed would also be transient in nature.
There's flexibility in attenuate ability of the dosing.
This is a there's a wide variety of presentation in this disease. So that are in some cases, it may require lower or higher dosing and adjusted adjustable dosing there and thats something that this provides.
We also lack a steroid.
Co treatment at least so far with.
With respect to this therapeutic candidate and this is Uh huh.
Potentially a considerable advantage, especially in the OTC deficiency community. So we bring forward all of those elements.
And then Pat anything else to add.
One other point is that.
When are they due to the neonatal disease, so going after the younger kids.
We think our protein replacement with an mrna is ideal solution.
Correct.
Versus the other options out there.
Yes.
Part of that.
Neonatal OTC patients usually need a liver transplant from my understanding.
So do you view this more as a.
Replacing that need for liver transplant or as a bridging agent.
Both depending on the age of the participant in the data that we collect as you know throughout the next year.
Will help guide those decisions, but absolutely the full intent is to replace any need for protein army for liver transplant and establish normalcy.
Really be too disruptive medicine, but but in some cases it may be used as a bridge just to extend life.
To get you to the next.
<unk> stage of therapy.
Okay and then.
One could you have can you provide any color on near term milestones from the CFO .
Agreement.
I'll, let Andy address that we did mention that there's one $3 billion in development milestones across five targets.
Andy Yes.
We're not going to give specific to near term because what we've articulated is that you know.
The COVID-19 programs are going to be recovered by the milestones so.
That certainly will extend our runway significantly and I think.
Given kind of guidance that it'll be at least three years. So.
From that perspective that should alleviate any of the near.
About funding.
Alright, Thank you very much for taking my questions.
Yeah.
We will take our next question from Gena Wang with Barclays. Please go ahead.
Hi, This is sheldon on for Gena, Thanks for taking my questions.
One on the CF program another one on the BARDA agreement.
For the CF program you show the data from five O eight telecom patients EC cross selling.
In your phase one trial from the Cta what patient population are you going to batteries first because I suppose the mrna therapies.
<unk> in the past one patients which are not addressable by the current drugs. So good.
Could you share your thoughts on the target patient population in phase one and beyond.
And my second question is on the BARDA Award.
You mentioned that the $63 2 million was going to be spread out over three years.
So what.
What pace with cadence what should we expect those milestones and because it also covers the pandemic flu is there an overlap with the CSL collaboration work.
<unk> benefit from both.
Great.
There's a few questions. There I'll first I'll begin to address the first question that the phase one trial for CF is intended to involve healthy volunteers.
And the strategy the strategic thinking there as it allows us to escalate the dose and identify the dose parameters quickly.
And and therefore lock in the dose quickly and then when we transitioned to patients will be more optimistic about the specific dose.
With respect to I can address the BARDA related questions as well.
But but had anything to add or did I capture did I address the question on the CF.
Ctr Phase one question, Yeah, exactly as Joe mentioned, so as we're going into.
Volunteers and Thats, the regulatory feedback that we received and based on that regulatory feedback.
We're going into a healthy volunteers and to pick the dose.
And then of course on our phase two would it be looking into getting into patient and that will be a multiple dose study.
Yeah.
And with respect to the next question on it yes. It is correct that that $63 million.
Value award is spread over three years, but this is a cost reimbursement structure that is very typical that you see in BARDA agreements or agreements with the United States government. So there's nothing out of the ordinary with respect to how it's reimbursed.
And there was there a third question.
I think that is no.
Uh huh.
Yes.
Flu pandemic program also one of the Ah.
Indications are covered by the CSL.
Collaboration so are you going to also receive reimbursement from CSL.
Oh no no.
The BARDA agreement is considered separate.
I mentioned that.
That.
That CSL will.
Uh huh.
I'm, referring to my notes in the script, but.
Just give me a moment.
Yeah.
Yeah.
This response or.
I mentioned that because I want to be careful in my messaging with <unk>, just entering a new partnership but.
Okay.
Oh, there it is that the CSL collaborate the CSL collaboration agreement allows for Arcturus to performance obligations under the BARDA contract just to give clear guidance. There. So it is a separate agreement it.
We have a relationship with the government we can operate accordingly.
And.
Oh man on the CSR CSL R&D.
<unk> recently.
Said that they would approach working with Arcturus is using the best of both companies' technologies to what has advanced in each of the vaccine fields.
Got it very helpful. Thank you so much.
Yes. Thank you.
We will take our next question from Yale Jen.
<unk> company. Please go ahead.
Good afternoon, and thanks for taking the questions.
Yeah.
154 will be the same or double that.
Toby vaccine would it be at all or.
Well.
Over with a new version of Colgate vaccine.
Well you can imagine all of the above, but but the strategic thinking and direction and messaging pertaining to <unk> 54, and any sort of the.
Future derivatives is gonna be communicated by CSL. So.
It would be inappropriate for me to provide guidance with respect to their strategic thinking on any future derivatives.
Okay, maybe just one more follow up here would you.
Gorilla glass.
32.
How should we think about based on the current preclinical data comparing to.
Sure.
The upstream.
Maybe you already are won or any.
Paris, something you can make around that.
Yeah, I'll start and allow.
Well pad to to fill in so many gaps or provide any additional comments.
We have some unique aspects to our CF therapeutic it's the only one that I know that utilizes the lunar delivery technology.
We we've applied our proprietary and trade secret know how on the manufacturing of this of the.
Messenger RNA, so its suitably pure four for inhalation applications.
And then with respect to the data we have showed.
Data in healthy animals in mice rats, ferrets and primates and this new data set is a fifth animal model and this time, it's a CF ferret model and I think we're the only wants to have this collective set of data.
But but pad anything else to add with how this differentiates compared to other.
Yeah, you know from the data that we've seen at least you generated.
In the in the in vitro models, we look very very promising obviously.
Restored the CFT our expression too.
<unk> almost wild type level. So so that data is pretty encouraging we haven't seen a similar datasets with with others yet.
Okay, Great that's very helpful and congrats on the order development.
Yeah. Thank you Hill.
We will take our next question from.
Hum.
Wells Fargo Securities. Please go ahead.
Hi, Thanks for taking.
Taking my questions.
So first on the COVID-19, or rather the CSL milestones.
Reasonable to assume that.
The weight across different the five different programs might be different and the COVID-19 may be weighted more heavily in our milestones and if so could you share a proportion.
For that I'm sure the proportionate for that.
And then also hum on the new program.
You you plan on announcing sometime next year I'm wondering what features are you looking at in making the decision in terms of the biology, whether a derisked targets or novel targets and any other consider.
<unk> that goes into that decision.
Sure Yeah, two good questions Yaron. Thanks, so with respect to the first one.
I'll reiterate that there was $1 $3 billion in development milestones across five programs and while we haven't disclosed in and we will not disclose the relative amounts of each of those milestones and timelines. It is true that the COVID-19.
Vaccine is the most advanced and has the shortest development timeline remaining to potential approval of course as being the most advanced of those type programs, but other than that we were not disclosing any and any additional information with respect to the new targets that we're seriously considering to add to deliver therapeutic targets.
Uh huh.
We hold those cards very close to our chest.
We understand the value and the specific value of our therapeutic technologies, we've come to realize that the lunar technology is exceptional at.
Delivering large RNA molecules.
And that the technology is biodegradable and non accumulating and the applicability of this technology.
Through systemic administrations and inhaled administration, so we're going to definitely leverage our technology differentiation with the leaner delivery technology.
But with respect to specific guidance, it's too early to do that.
We there's other competitors as you can appreciate in this space.
We will.
We will be strategic when we when we provide more hence there.
Got it. Thank you for the color if I may add a question in Florida, The CF program.
With all of the animal models you have studied.
How.
In terms of a multiple dosing what's the experience there in terms of any potential immune reactions after multiple doses or antibody.
Antidrug antibodies and it seems that some work thank you.
Yeah, well I'll start with the most advanced animal human beings, and then I'll turn the time over to Pat to discuss some more collective preclinical evaluations in general of the of the lunar franchise.
But you know I want to reiterate that in our phase one study that we you know.
Our therapeutic has now been injected in phase one and phase one b. It's 29 people have received.
<unk> 10, and in the Phase one studies, we actively investigated and looked at lipid decomposition and.
And we are.
<unk> observed that there was no lipids remaining in the plasma after 48 hours. So that was viewed very positively in humans with respect to other safety parameters are.
Yeah. The Immunogen is now I'll turn the time over to Pat.
Yes.
We've talked about this in the past you might recall that we shared data of our nine month safety data at the nine month Tox data.
For the CF program for the OTC program, essentially we gave weekly dosing for <unk> for nine months in <unk> in nonhuman primates, and we didn't see any loss of activity.
The delivered protein so that was pretty encouraging for us showing the alumina was at least pre clinically it.
Sure.
Promise.
Got it thank you for the color.
Okay.
Thanks Shannon.
At this time there are no further questions in the queue I would like to turn the conference back to your presenters for any additional or closing remarks.
No closing remarks, just thanks for participating on the call and if theres any remaining questions. Please reach out to the team and we'll get back to you right away. Thanks to everyone can I.
Ladies and gentlemen. This concludes today's conference. We appreciate your participation you may now disconnect.
Okay.
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