Q2 2019 Earnings Call
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unknown: Good morning, and welcome to the Voyager Therapeutics 2nd Quarter 2019 Financial Results and Corporate Highlights Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star then zero on your touchtone telephone. Please be advised that this call is being recorded at the company's request. At this time, I'd like to turn the call over to Allison Dorval, Voyager's Chief Financial Officer. Please proceed.
Good morning, and welcome to the Voyager Therapeutics second quarter 2019 financial results and corporate highlights conference call.
At this time all participants are in listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time, if anyone should require assistance. During the conference. Please press Star then zero on your touched on telephone.
Please be advised that this call is being recorded at the company's request.
At this time I'd like to turn the call over to Allison Dorval.
Wagers Chief Financial Officer. Please proceed.
Thank you good morning, and welcome to the call earlier today, we issued a press release, which outlines the financial results and corporate highlights for the second quarter of 2019, the releases available at Voyager Therapeutics Dotcom.
Allison Dorval: Thank you. Good morning, and welcome to the call. Earlier today, we issued a press release that outlines the financial results and corporate highlights for the second quarter of 2019. The release is available at voyagertherapeutics.com. Before we begin, just a reminder that the forward-looking statements included in this call represent the company's views as of today, August 9, 2019, and Voyager disclaims any obligation to update these statements to reflect future events or circumstances, except as required by law. Please refer to today's press release as well as Voyager's filings with the SEC for information concerning risk factors that could cause actual results to differ materially from those expressed or implied by such statements. With that, I'll pass the call over to Andre.
Before we begin just a reminder that the forward looking statements included in this call represent the company's views as of today August nine 2019, Voyager disclaims any obligation to update these statements to reflect future events or circumstances, except as required by law. Please refer to today's press release as well as voyager's filings with the SEC for information concerning risk factors that could cause actual results to differ materially from those expressed or implied by such statements with that I will pass the call over to Andre.
Andre: Thank you, Allison, and good morning, everyone. Welcome to our Q2 Earnings and Corporate Highlights call. Today, I'll discuss selected elements of our portfolio evolution, including the recent restructuring of our gene therapy relationship with Sanofi Genzyme. Next, Omar Khawaja, our Chief Medical Officer and Head of R&D, will comment on our existing programs and new discovery efforts. Allison will wrap up the call with a discussion of our second quarter results
Thank you Allison and good morning, everyone welcome to our Q2 earnings and corporate highlights call.
Today, I'll discuss selected amounts of our portfolio and dilution, including the recent restructuring of our gene therapy relationship with Sanofi Genzyme.
Next Omar Khwaja, our Chief Medical Officer, and head of R&D, who will comment on our existing programs and new discovery efforts.
Allison will wrap up the call with a discussion of our second quarter results Madoff merger, our Chief operating officer as also join us for the Q and after our prepared remarks.
Andre: Matt Ockmer, our Chief Operating Officer, has also joined us for the Q&A after our prepared remarks. We entered 2019 with the focused strategic vision of becoming a leading fully integrated biopharmaceutical company focused on AAV gene therapy for severe neurological disease. And in the second quarter, we continue to take steps in achieving that goal. As we've outlined previously, under our plan, we will pursue new program opportunities with three distinct approaches. The first approach is to advance novel discovery programs with a partner up to an early point, typically the IND stage, when the partner takes on full development and future commercial responsibility. Our partners provide an up-front payment and fund the research activities through cost reimbursement, and we're typically eligible for near-term development milestones, later stage milestones, and royalty payments, all of which can be funneled back into our operations. Both programs with AbbVie as well as the Discovery programs with NeuroCrim follow this approach.
We entered 2019 with the focus strategic vision of becoming a leading fully integrated biopharmaceutical company focused on a the gene therapy for severe neurological disease.
And in the second quarter, we continued to take steps in achieving that goal.
As we've outlined previously under our plan, we will pursue new program opportunities with three distinct approaches.
The first approach is to advance novel discovery programs with a partner up to an early point typically behind these stage when the partner takes on full development and future commercial responsibility.
Our partners provide an upfront payment and fund the research activities through cost reimbursement and we're typically legible for near term development milestones letters third stage milestones and royalty payments all of which can be funneled backed into our operations.
Both programs with Abbvie as well as the discovery programs with Neurocrine follow this approach.
Andre: We're currently eligible for up to more than $300 million in preclinical milestone payments over the coming years across these programs. In their second approach, we advance existing development programs and candidates with the support of partners' funding and resources but retain co-development and co-commercialization rights. Are Parkinson's and pre-ecstasy programs with Nercrin aligned with this approach? Working with selected partners in this way allows us to do more while maintaining an option for meaningful commercial participation. Finally, in the third approach, we advance promising programs on our own and retain full upside value.
We're currently eligible for up to more than 300 million in preclinical milestone payments over the coming years across these programs.
On there to segment approach, we advance existing development programs and candidates with the support of partners funding and resources, both retain co development and co commercialization rights, our Parkinson's and predicts with Akcea programs with nurturing aligned with this approach.
Working with selected partners in this way allows us to do more while maintaining an option for meaningful commercial participation.
Finally in the third approach, we advance promising program on our own and retain full upside value.
Andre: In June, we announced the key development in that part of our portfolio with the restructuring of our gene therapy relationship with Sanofi Genzyme. With this transaction, we were able to gain worldwide rights to the Huntington's program, ex-U.S. rights to the Frederick's Ataxia program, and to eliminate Sanofi Genzyme's option to a future option or FemDisease program. In turn, we transferred the ex-U.S. rights to the pre-ecstasy program to Neurocrin under the terms of our calibration agreement, and in doing so, we greatly simplified the future execution of this program. Part of the value exchange with Sanofi Genzyme was the granting of certain IP rights concerning the spinal muscular atrophy program previously included in the collaboration and the granting of exclusive rights to certain of our capsids for use in two non-CNS indications. Doing so allowed us to reduce our cash outlay for the rights we got.
In June we announced a key development in that part of our portfolio with the restructuring of our gene therapy relationship with Sanofi Genzyme.
With this transaction, we were able to gain worldwide rights to the Huntington's program ex us rights to the predicts that actually a program and to eliminate Sanofi genzymes option to a future option orphan disease program.
In turn we transferred the ex us rights to the predicts that the Akcea program to Neurocrine sort of terms of our collaboration agreement.
And in doing so we greatly simplified the future execution of this program.
Part of the value exchange with Sanofi Genzyme was the granting of certain IP rights concerning the spinal muscular atrophy program previously included in the collaborations and the granting of exclusive rights to certain of our Capsids for use in two non CNS indications.
Doing so allowed us to reduce our cash outlay for the rights we got.
Andre: Gaining global rights to the Huntington's program was our primary motivation for this restructuring. There is no existing treatment for Huntington's disease, which affects around 30,000 people in the U.S. alone. As we've discussed in the past, we're encouraged by the results of our preclinical studies. We presented data showing that through the administration of VY-HTT01 in the putamen and thalamus of large animals, we can significantly reduce HTT gene expression in both deeper tissues and outer layers of the brain.
Gaining global rights to the Huntington's program was our primary motivation in this restructuring.
There is no existing treatment for huntingtons disease, which affects around 30000 people in the us alone.
As we have discussed in the past we're encouraged by the results of our preclinical studies.
We presented data showing that through administration of the Y HD deal won in the putamen and thalamus of large animals, we can significantly reduce HDD gene expression in both deeper tissues and outer layers of the brain.
Andre: Our delivery leverages the experience we've gained from our Parkinson's program, and we believe we can make a meaningful impact on those affected by this. We're currently working on IND-enabling studies. If successful progress is made, we may be in a position to file an IND by the end of 2019. In connection with the restructured centrifuge-enzyme relationship, we decided to alter the deployment of our resources.
Our delivery Leverages the experience we've gained.
From our Parkinson's program, and we believe we can make a meaningful impact to those affected by this disease.
We're currently working on R&D, enabling studies if successful progress is made we may be in a position to file the 90 by the end of 2019.
In connection with the restructured Sanofi Genzyme relationship, we decided to alter the deployment of our resources.
Andre: In order to focus on the Huntington's program and other new discovery programs, we intend to work with a partner to advance our efforts in ALS, and we've begun to engage in discussions with potential collaborators. As we take these steps to reshape and advance our portfolio, we're continuing to build on our expertise and strengthen our management team. During the past quarter, we expanded Omar's role to Chief Medical Officer and Head of R&D. We're also very pleased to have recruited Kelly Bales, who is joining us in September as Senior VP of Research and Head of Neuroscience. Kelly was most recently at Roche, where she was Global Head of Neuroscience Discovery. We expect that our efforts on new discovery targets, along with our capsid discovery efforts, could result in exciting additions to our pipeline programs in the months to come. But we're not solely relying on internal efforts. We're also actively engaged with potential academic and corporate partners to assess programs, expertise, and technologies that may help us further our efforts. I look forward to providing additional updates on our portfolio in the near future. With that, I'll turn the call over to Omar. Omar?
In order to focus on the Huntington's program at our new discovery programs, we intend to work with a partner to advance our efforts NLS and we've begun to engage in discussions with potential collaborators.
As we're taking these steps to reshape and advance our portfolio, we're continuing to build on our expertise and to strengthen our management team.
During the past quarter, we expended omars role to Chief Medical Officer and head of R&D.
We're also very pleased to have recruited Kelly bells, we Jones, who is joining us in September .
As senior VP of research and head of neuroscience.
Kelly was most recently at Roche, where she was global head of neuroscience discovery.
We expect that our efforts on new discovery targets, along with our capsid discovery efforts could result in exciting additions to our pipeline programs and in months to come.
But we're not solely relying on internal efforts. We're also actively engage with potential academic and corporate partners to assess programs expertise and technologies that may help us further our efforts.
I'll look forward to providing additional updates on our portfolio in the near future.
With that I'll turn the call over to Omar Omar.
Omar Khawaja: Thank you, Andre. I want to start by saying that I am excited to be part of Voyager's next phase. Building on a solid scientific foundation, the company is an innovator in gene therapy for severe neurological disease with a wealth of knowledge in the discovery and development of AAV-based therapeutics. Importantly, that includes robust expertise in gene delivery to the human brain and the learnings from several years of direct clinical experience. I was drawn to Voyager by the scientific rigor of the company and the potential of this modality to help people affected by severe neurological diseases.
Thank you Andre I will start by saying that I'm excited People's religious next say.
Building on a solid scientific foundation. The company is an innovative gene therapy for today and neurological disease.
With a wealth of knowledge and discovery and development of a based therapeutics.
Importantly that includes robust expertise and gene delivery to the human brain on the learnings from several years of direct clinical experience.
Postal village at by the scientific rigor about the company and the potential that this modality to help people affected by it and neurological diseases.
Omar Khawaja: I'm even more enthusiastic as I've come to understand, at a deeper level, the outstanding knowledge and experience of the team and the opportunity to work with such a deep bench of expert scientists at the convergence of AAV gene therapy and neuroscience. Together with our collaboration partners, as well as in our own wholly-owned effort, Voyager is now poised to even more fully explore the potential role for gene therapy in Addressing the Enormous Unmet Need for Neurological Diseases, as well as to open up the addressable target space for these disorders and overcome the challenge of therapeutic delivery to the nervous system. First, I'll focus on our collaboration with Neurocrin. On the Parkinson's program, our teams are well-integrated and collaborating on the execution of the first pivotal trial, including the activation of new trial sites and advancing enrollment. We're also progressing on the regulatory front with the finalization of our statistical analysis plan for Restore 1. On the Friedrichs program, we've made much progress since agreeing on the development plan.
I am even more enthusiastic as that comes on the stand at a deeper level outstanding knowledge and experience to the team.
And the opportunity to work with such a deep bench of X, but scientists at the convergence of 18 therapy neuroscience.
Together with our collaboration partners as well as in our own wholly owned asset voyage is now poised to even more fully explore the potential role for gene therapy in addressing the enormous unmet need and neurological diseases.
As well as opening up the addressable target space These disorders.
And overcoming the challenges of therapeutic deliveries and that system.
Yes ill focus on our collaboration with no credit.
On the Parkinson's program, our teams are well integrated and collaborating on the execution of the first pivotal trial.
Including the activation of new trial site and advancing enrollment.
We're also progressing on the regulatory front with the Finalization of our statistical analysis plan service told one.
On the fleet its program we've made much progress having agreed on the development plan, we now executing against that plan and working towards selecting our lead clinical candidate.
Omar Khawaja: We're now executing against that plan and working towards selecting our lead clinical candidate. We've also taken important steps towards our two new discovery programs with NeuroQuint. The planning process has been highly informative to date, the two companies are working closely, and we expect Neurocrin to nominate its final targets for these discovery programs in the coming months. Our collaboration with AbbVie is also progressing according to plan. At ASGCT this year, we presented encouraging results from the Vectorized Anti-Tau Program. Systemic dosing using a novel capsid and cell-type specific promoters resulted in anti-tau antibody expression in neurons and astrocytes at levels many times higher than that previously achieved with passive immunization. Moving forward, we're now evaluating the efficacy of vectorized anti-tau antibodies in animal models of Alzheimer's disease.
We've also taken important steps towards our two new discovery programs with Quinn.
The planning process has been highly informative to date.
The two companies are working closely and we expect credit will nominate that final targets to these discovery programs in the coming months.
Our collaboration with Abbvie is also progressing according to plan.
Ask GCT. This year, we presented encouraging results from the vet tries to Andrew how pipeline.
Systemic dosing using a novel capsid and cell type specific parameters resulted an anti tau antibody expression and neurons and astrocytes at levels, many times higher than that previously achieved with passive immunization.
Moving forward, we now evaluating the efficacy in fact try thanks tile antibody in animal models of Alzheimer's disease.
Omar Khawaja: Our learning from the TAO program is also being used to inform our efforts on the Alpha-synuclein program, which has begun more recently and is proceeding well. We were active at ASGCT with presentations of preclinical data from across several of our discovery activities. I won't go through each, but I do want to point out the presentation on proof-of-concept data relating to our TRACER system. This is a platform that allows us to rapidly evolve, screen, and select novel AAV capsids with specific characteristics. We're applying the tracer system to discover capsids with improved blood-brain-barrier penetrant properties in primates.
Our learning from the top program is also being used to inform our assets on the Alpha Synuclein program that has begun more recently and is proceeding well.
We were active asked GCP with presentations of preclinical data from across several of our discovery activities.
I wouldn't get too Leach, that's I do want to point out the presentation on proof of concept data relating to our traces system.
This is a platform that allows us to rapidly evolve screen and select novel Avi Capsids with specific characteristics.
We are applying the traces system to discover caps fits with improves blood brain barrier penetrate properties in primates.
Omar Khawaja: This system will be foundational as we seek to build the next generation of gene therapies for neurological disease. We're evaluating our resources across each of our priorities to ensure that we remain focused on value-driving activities for the remainder of 2019. We'll be focused on readying the Huntington's disease program for a potential IND filing and entry into patients, while also prioritizing the identification and validation of new discovery targets and investing more in our novel-captured work. We're interrogating a number of potential new targets through our partnership with Neurocrin as well as separately on our own. We've created a focused cross-functional team to assess potential targets based on scientific feasibility, including technical and biological hurdles, market opportunity, strategic fit, as well as competitive risk, and most importantly, potential therapeutic impact. We have an exciting portfolio and look forward to providing updates on both existing and new programs. I'll now pass the call on to Alison for the financial update. Alison?
This system will be foundational as we seek to build the next generation of gene therapies for neurological disease.
We are evaluating our resources across each of our priorities to ensure that we remain focused on value driving activities for the remainder of 2019.
We'll be focused on letting the huntington's disease program for a potential R&D filing and entry into patients. While also prioritizing the identification and validation as new discovery targets and investing more in our novel capsid when.
Where entire great interrogating, a number of potential new targets through our partnership with Notikewin as well as separately on all right.
We've created a focused cross functional team to assess potential targets based on scientific feasibility, including technical and biological hurdles.
Market opportunity strategic fit as well as competitive risk and most importantly potential therapeutic impact.
We have an exciting portfolio and look forward to providing update on both existing and new programs.
I'll now pass the call on to Allison for the financial update Allison.
Allison Dorval: Thanks, Omar. Voyager reported net income of $11.2 million, or $0.30 per basic share, for the second quarter ended June 30, 2019, compared to a net loss of $25.5 million, or $0.80 per share, for the second quarter of 2011. Collaboration revenues of $46.1 million for the second quarter ended June 30, 2019, compared to collaboration revenues of $2.6 million for the second quarter of 2008. These revenues reflect the recognition of non-cash amounts for research services that we performed for various programs under the Sanofi-Genzyme, Appy, and Nurocrine collaboration agreements, in addition to amounts expected to be reimbursed by Nurocrine as per that collaboration agreement. The amounts can vary based on quarterly assessments of our efforts under each of those collaborations.
Thanks Omar.
Voyager reported net income of $11.2 million or 30 cents per basic share for the second quarter ended June 32018, compared to net loss of $25.5 million or 80 cents per share for the second quarter of 2018.
Collaboration revenues of $46.1 million for the second quarter ended June 32019, compared to collaboration revenue of 2.6 million for the second quarter of 2018.
These revenues reflect a recognition of non cash amounts for research services that we perform for various programs on the Santa Fe Genzyme Abbvie and Neurocrine collaboration agreement. In addition to amounts expected to be in the third.
As per that collaboration agreement.
Amounts can vary based on quarterly assessments efforts under each accounts collaboration.
Allison Dorval: In the second quarter ended June 30, 2019, collaboration revenues also included the one-time recognition of $28.7 million of previously deferred amounts related to the termination of the Sanofi Genzyme Collaboration Agreement. Under the termination agreement, we paid $10 million upfront to Sanofi Genzyme and will pay an additional $10 million upon the filing of an IND for the Huntington's program. We also agreed to pay low single-digit royalties to Sanofi Genzyme on net sales of a Huntington's Disease product and entered into an amended capsid agreement with Sanofi Genzyme at the same time. Under this agreement, Sanofi Genzyme can evaluate six of our capsids and can opt to exclusively license up to two for use in two specified non-CNS indications.
In the second quarter ended June 32019 collaboration revenues also included the onetime recognition of $28.7 million previously deferred amounts related to the termination of the Santa Fe Genzyme collaboration agreement.
Under the termination agreement, we paid $10 million upfront to Sanofi Genzyme and will pay an additional $10 million upon the filing of an eye handy for the Huntington's program.
We also agreed to pay low single digit royalties to Santa Fe Genzyme on net sales of one huntingtons disease product and entered into an amended capsid agreement with Sanofi Genzyme at the same time.
Under this caps that agreement Santa Fe, Genzyme can evaluate six of our capsids and can opt to exclusively license uptick to for use into specified non CNS indications.
Allison Dorval: The revenue recognized in the quarter included $48.7 million, which was remaining in deferred revenue at the termination date, offset by the $10 million upfront payment and the $10 million we expect to pay upon the filing of an IND. Additionally, we revised our collaboration agreement with Neurocrin and received $5 million from Neurocrin to facilitate the transfer of the ex-U.S. rights to the Friedrichs program for them. The remainder of the increase in collaboration revenue during the second quarter of 2019 compared to the same period in 2018 primarily relates to an increase in the non-cash amounts for research services performed under the AFI and Nurocrin collaborations and to the recognition of amounts expected to be reimbursed under the Neurocrine Agreement, which commenced in March 2008.
The revenue recognized in the quarter included 48.7 million, which was remaining in deferred revenue at the termination date offset by the $10 million upfront payment and the 10 million, we expect to pay upon the filing of the handy.
Additionally, we revised our collaboration agreement with American and received $5 million from American to facilitate the transfer of the ex us rights to the Friedrichs program.
The remainder of the increase in collaboration revenue during the second quarter of 2018 compared to the same period in 2018, primarily relates to an increase in the non cash amounts our research services performed under the assay and Neurocrine collaboration.
And to the recognition of amounts expected to be reimbursed under the Neurocrine agreement, which commenced in March 2019.
R&D expenses of $28.6 million for the second quarter ended June 32019, compared to 16.5 million.
Allison Dorval: R&D expenses of $28.6 million for the second quarter ended June 30, 2019, compared to $16.5 million for the second quarter of 2018. These expenses include costs incurred under the Neurocrine Collaboration, which are expected to be reimbursed. The increase in R&D expenses in the second quarter of 2019 related primarily to expenditures associated with the development of our product pipeline, including costs related to our RESTORE-1 Phase II clinical trial for VYA-ADC and increased personnel and facility costs to support the advancement of our pipeline program. General and administrative expenses of $8.3 million for the second quarter ended June 30, 2019, compared to $11.8 million for the second quarter of 2018. The decrease in GNA Expenses in the Second Quarter of 2019, primarily due to the one-time recognition of $5.4 million of stock-based compensation related to the modification of stock options in the second quarter of 2018.
The second quarter of 2018.
These expenses include costs incurred under the Neurocrine collaboration which are expected to be reimbursed.
The increase in R&D expenses in the second quarter of 2019 related primarily to expenditures associated with the development of our product pipeline, including costs related to our restore one phase two clinical trial for FY, HTC and increased personnel and facility costs to support the advancement of our pipeline program.
General and administrative expenses of $8.3 million for the second quarter ended June 32019, compared to $11.8 million for the second quarter of 2018.
The decrease in Jan and expenses in the second quarter of 2019, primarily due to the onetime recognition of 5.4 million.
Based compensation related to the modification of stock options in the second quarter of 2018.
Allison Dorval: This was partially offset by an increase in other employee-related expenses, consulting, and professional fees to support the advancement of our pipeline programs, R&D platform initiatives, and manufacturing capabilities. As of June 30, 2019, we had $327.5 million in cash, cash equivalents, and marketable debt security. We continue to expect to end 2019 with $280 million to $290 million of cash, cash equivalents, and marketable debt securities, which we project will be sufficient to meet our operating needs and capital expenditure requirements into mid-2022. With that, I'd like to now open the call to questions. Operator?
This was partially offset by an increase in other employee related expenses consulting and professional fees.
Fourth the advancement of our pipeline program.
Our new platform initiatives and manufacturing capabilities.
As of June 32019, we had 327.5 million cash cash equivalents and marketable debt securities. We continue to expect to end 2019 280 million to 290 million of cash cash equivalents.
And marketable security, which we project will be sufficient to meet our operating needs and capital expenditure requirements into mid 2022.
With that we'd like to now open the call for questions operator.
Thank you ladies and gentlemen, if you have a question at this time. Please press. The Star then the number one key on your Touchtone telephone. If your question has been answered or you wish from Weve yourself from the queue. Please press the pound key again, that's star then one to ask a question.
unknown: Thank you. Ladies and gentlemen, if you have a question at this time, please press the star, then the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Again, that's the star, then one to ask a question. In the interest of time, we ask that you please limit yourself to one question and a follow-up. And our first question comes from Dane Leone with Raymond James.
In the interest of time, we ask that you. Please limit yourself to one question and a follow up.
And our first question comes from Dane Leone with Raymond James.
Your line is now thank you.
All right. Thank you so much and thank you for the update I just wanted to maybe get more color. If you could on what the blocking and tackling needs to be done.
Dane Leone: Your line is now open. Thank you. Hi. Thank you so much, and thank you for the updates. I just wanted to maybe get more color, if you could, on what the blocking and tackling needs to be done on Huntington's IND, you know, what they'll need to do internally, whether it's more bench work or work with the translational models or more on the manufacturing side. That would be great.
On the Huntington's Hi, Andy what's still need to do internally.
Whether it's more on bench work or work with the translational models.
Or more on the manufacturing side that'd be great. Thank you so much.
Great. Thanks vein Oscar Omar to answer your question.
Yeah. Thanks, Thanks for the question so.
I'd like to see that we're focused on are really running full centralized D filing if things line up towards the end of the year, So with add finishing up the enlite phases of some of the non.
Omar Khawaja: I'll ask Omar to answer your question.
Omar Khawaja: Yes, thanks Zane for the question. So the current activities that we're focused on are really readying for potential IND filing if things line up towards the end of the year. So we're finishing up the in-life phases of some of the preclinical GLP toxicology studies and collecting that data, including the bioanalytics and knockdown information that will be necessary to support the IND filing. The second activity is we've built out the clinical team led by Steve Hirsch, who's our Vice President of Translational Medicine and a Huntington's disease expert. We've held two scientific advisory boards for planning for the entry into patients and are in the last stages of finalizing the protocol for that phase one, phase two study. And then the third aspect is the development of the biomarker modeling, as well as the biomarkers that will be used in the clinic themselves, as well as wild-type and mucin-Huntington protein biomarkers, the neurodegeneration biomarker suite that we'll also put And then we're also in the final stages of our rodent efficacy model, mouse model studies that will be used to support the IND filing, as well as help us build the translational model to ensure that we're starting with clinically efficacious doses that are predicted to be clinically efficacious with our first entry into the clinic.
The preclinical GLP toxicology studies and collecting that data.
Including the bi analytics and knocked out information that will be necessary to support the R&D filing.
The second activity as we've as stop built how the clinical team led by Steve has his own vice President of translational medicine, and Huntingtons disease expert we've held to scientific advisory boards full of planning for the entry into patients and in the last stages of finalizing the protocol for phase one phase two study.
And then the fed aspect is that development of the biomarker modeling as well as the Biomarkers that will be used in the clinic themselves as well as well taught the meetings and at least in Huntington protein and.
Uh huh.
At this time, all because the newer generation Biomarkers suite that will also put around that as well as potential imaging biomarkers as well.
And then we're also in the final stages of.
Right and Tensixty modal add mouse models studies that will be used to support the R&D filing as well as help us build the translational model to ensure that we're starting with clinically efficacious doses that are predicted to be clinically efficacious with.
Our first entry into the clinic.
Great and just one follow up on that and this probably isn't it fair question assay speculate, but do you have there been any learnings from what you've seen.
Omar Khawaja: Great. And just one follow-up on that, and this probably isn't a fair question to ask you to speculate, but have there been any learnings from what you've seen, you know, I guess specifically what we all looked at during AAN this year in terms of biomarkers and maybe specifically NFL? In terms of, you know, disease, disease response, or disease control with this type of therapy.
I guess, specifically, what we all looked at during a 10 this year.
In terms of Biomarkers, and maybe specifically NFL.
In terms of disease.
Disease response or disease control with this type of therapy.
Yes, I mean, I think that you know the data that was presented that from the rush I announced program as well as in that that was published in the New England Jan Madsen earlier this year.
Omar Khawaja: Yes, I mean, the data that was presented from the Rosh Ionis program as well as that that was published in the New England Journal of Medicine earlier this year, I think the NFL findings are still unclear why, you know, there was an increase rather than a decrease. We will be measuring, plan to measure NFL in our own clinical studies. I think one of the key things that the community generally, and we're leveraging our close collaboration with CHDI in this, is really trying to understand the relationship of these biomarkers with clinical progression from natural history cohorts. And we hope that that data is going to be informative as we start to interpret these biomarkers in our clinical program.
I think the NFL findings as Phil is on unclear why you know they there was it an increase rather than the decrease.
We will be measuring uptime to measure NFL, then I'll run clinical studies I think one of the key things that that community generally and.
We are leveraging all close collaboration with CHP high and this is really trying to understand the relationship of these biomarkers with clinical progression from natural history cohorts and we hope that that data is going to be informative as we start to interpret these biomarkers in a in our clinical program.
Excellent. Thank you so much.
Thank you.
Omar Khawaja: And our next question comes from Phil Nadeau with Cowan & Company. Your line is now open. Morning, thanks for taking my questions. First, one question on RestoreOne. It seemed from your prepared remarks that there may have been a change in the design and specifically the statistical analysis plan. Is that accurate, or did we misinterpret your comments?
And our next question comes from Phil Nadeau with Cowen and company. Your line is now open.
Good morning, Thanks for taking my questions first one question restore one it seems like from your prepared remarks that may have been a change in the design and specifically the statistical analysis plan.
He said our crude or did we misinterpret your comments.
Thanks, Phil.
So this is Andre and the mountain Omar can also add to this so we shared with everyone earlier. This year that we had a plan for 75 to 100 patients the size trial and restore one and.
Andre: Thanks, Phil. So, this is Andre, and Matt, and Omar can also add to this.
Andre: So, we shared with everyone earlier this year that we had a plan for a 75 to 100 patient-size trial and a restore one. And we shared also that point that we would look to finalize our SAP to determine, predetermine the precise target number of patients that we would like to enroll. So, that was prior to entering into a relationship with Neurocrin. So, now we're working with them to define the target number of patients that we're going to look to enroll. And we may look, as we do that, to make also any potential minor amendments to the protocol, but these, I would say, are more of the standard, so there's not a revisit of the protocol at a higher level than that. If there are some amendments that are meaningful, we will, of course, let, we'll inform everyone of these changes, but one thing that Omar alluded to that we are clearly looking to do as we had planned is to finalize that SAP and the target number of patients.
We shared also at that point that we would look to finalize our SAP to determine the predetermine the.
Precise target number of patients that we would look to enroll so that was prior to its rains relationship with American.
So now we're working with them to define the target number of patients that we're going to look to enroll and we may look as we do.
That.
To make it also.
Any potential a minor amendments to the.
Recall, but these I would say are more Uh huh.
The the standards. So there is not a theres not a revisit of the.
Protocol at a higher level than that if there are some amendments that are meaningful we will of course, but.
Will inform everyone of these changes, but but one thing that as Omar alluded to that that we are.
Katy looking to do as we had planned it was too to finalize that sat.
And the target number of patients.
Andre: Perfect. And do you have any updated guidance on the timelines for RestoreOne in terms of when we could see the data?
Perfect and do you have any updated.
Guidance on the timelines for restore one in terms of.
When we could.
See the data.
So we expect that we will be able to give further.
Andre: So we expect we will be able to give further clarity around that once we do have a target number of patients and take into account the enrollment rate. So again, we'll work with our partner to be able to give that guidance, but that will naturally follow the determination of how many patients we're going to aim for in that range.
Clarity around that once we do have a target number of patients and then take into account that the enrollment rate.
So again, we'll work with our partner to be able to give.
That guidance, but I will follow naturally the determination of how many patients were going to aim for in that range.
Philip M. Nadeau: Fair enough. Thanks for taking my question. Thanks, Phil.
Fair enough thanks for taking my questions.
Thanks, Phil.
Debjit Chattopadhyay: Thank you. And our next question comes from Debjit Chattopadhyay, with HC Wainwright. Your line is now open. Hey guys, good morning. This is Aaron Welch on DevJet. The AAV vector that's being used for the Huntington's disease program. I saw on your corporate deck that you mentioned that there is going to be a passenger strand or that you're cognizant of the passenger-to-guide strand ratio, so could you tell us anything about how much of a ratio there may be?
Thank you and our next question comes from Debjit Chattopadhyay with H.C. Wainwright. Your line is now open.
Hey, guys. Good morning, this is Aaron Welsh on for Debjit.
So I just had a question about the.
The.
Avi vector its being used for the Huntington's disease program.
Well I saw in your.
Corporate debt.
You bet.
You mentioned that there it looks like there is going to be a passenger strander or that you're.
Your.
Cognizant of that.
Passenger to guidance trend ratio, so could you tell us anything about.
Yes.
How about how much of a ratio there maybe.
Omar Khawaja: Thanks, Erin, for your question. I'll ask Omar to touch on this.
Yes, thanks, everyone for your question I'll ask Omar to to touch on this we have not the shared a in our prior publication the.
Omar Khawaja: We've not shared in our prior publication the precise ratio, but as we develop these primary microRNA programs and these cassettes, we have some guiding rules as we apply our expertise from one program to the other as to what looks to be an optimal amount of guide-to-passenger ratio. So that's informed from prior work we've done and what others have done. But so these are minimum thresholds that we look to have as a screening criteria to select our candidates for each program, but we don't have a precise disclosure here on neither the Huntington nor the ALS to share, but that's the approach we take on this across our programs.
Prcised ratio, but as we develop these primary macro R&D programs and the skill sets we have some guiding roles as we.
Apply our expertise from one program to the outer as to what looks to be an optimal amount of guide to passenger ratio. So thats inform from prior work, we've done and what orders up Dom.
But so these are these are minimum thresholds that we look to have.
As a screening criteria today too.
To select our candidates for each program.
But we don't have a precise disclosure here on entered on thing through and nor the LLS.
To share, but thats the approach of how we.
How we look at this across our programs.
Omar Khawaja: Yeah, I don't think there's a lot to add to that. The key factors that we look at, obviously, that affect the potency of the transgene include the guide to passenger ratio. We do have some broad rules that help us optimize this, but I don't think we're going to disclose the precise ratio as it relates to Huntington's program.
Yes, I don't think that that a lot tighter bass I you know the key factors that we look at obviously it you know that affect the potency is that.
All of the Transgene include the guide to passenger ratio, we do have.
Some broad rules that help us optimize this but I don't think we're going to disclose the precise ratio as it relates to the Huntington's program.
Okay Alright.
Omar Khawaja: Okay, all right. And real quick, do you guys... I know you haven't disclosed the exons that are being targeted, but would you be able to tell us if there's any consideration for mutant allele specificity or allele specificity when considering which exons to go after? Thank you.
And real quick are you guys.
I know you havent disclosed the zones that are being targeted.
Would you be able to tell us yes.
If there is any consideration for.
You know legal specificity or a little specificity, when considering which exxon's.
Go after.
Thank you.
That's a good question. So we taking I know not little specific approach considerations around now those businesses was really to add.
Omar Khawaja: Those are good questions. So, we are taking a non-allele-specific approach. Considerations around allele specificity were really to, you know, have a gene therapy that would be able to cover the broad Huntington's population and the challenges of developing SNPs, you know, SNPs with really broad coverage of the Huntington's population that would allow us to really ensure that our gene therapy would be accessible to the broad majority of patients who might benefit from it. The other way of addressing allele specificity is to target the actual We have stayed away from that approach because of, you know, the fact that there are other genes that contain that repeat and the risk of off-target or unwanted effects by targeting other genes with an siRNA to that region. So, you know, that together with the data that exists on the safety of a non-allele specific approach, we decided to stick with a non-allele specific approach.
You know how that have a gene therapy that would be able to cover the broad huntingtons population and.
The challenge is that developing SNET eat I snatched with release at.
Broad coverage of the Huntington's population that would allow us to.
Really ensure that we have with that.
Our gene therapy would be accessible to that to the board majority of patients with as you might benefit from it.
The other you know.
Way of addressing our little specificity as to target the theatrical repeats itself. We have stayed away from that the price because of you know the fact that that other genes that contain at that Kate contain that repeat and the risk of a target or on one that effects probably talking to other genes.
With a national M&A to that region. So.
You know that's it together with the data that exists on that.
Safety all non out little specific approach, we've we've decided to to stick with the no no specific approach.
Okay, great. Thanks for the clarity guys.
Omar Khawaja: Okay, great. Thanks for the clarification.
Thank you and our next question comes from Tom Shrader with BTG. Your line is now open.
Tom Schrader: Thank you. And our next question comes from Tom Schrader with BTIG. Your line is now open. Good morning.
Hi, good morning, Thanks for taking the question.
Tom Schrader: Thanks for taking the question. You just answered some of them, but it was one sort of broad survey question. AAV capsid development is incredibly, Crowded right now, and I'm just kind of from a survey point of view. What's your sense of how good primate data are? Are they quantitatively predictive? Is there a sense yet? I know there have been some negative surprises from mice, but your sense of how much confidence we should have from primate readouts would be helpful.
You just answered some of them but.
One sort of broad survey question Avi capsid.
Development is incredibly.
Yeah crowded right now and I'm, just kind of from a survey point of view.
What's your sense of how good primate data or are they.
Quantitatively predictive is the is there a sense yet I know there have been some negative surprises from mice, but your sense of how much confidence we should have from primate read outs would be helpful.
Yeah, I think that that's a great question I mean, I think just from that just at a very high level. We we feel that the composition of the prime at blood brain barrier. The non human primate is likely to be more translates well to the human situation than then then mouse and particularly I think as you say the surprises which have come way even.
Omar Khawaja: Yeah, that's a great question. I mean, just from a very high level, we feel that the composition of the primate blood-brain barrier, the non-human primate, is likely to be more translatable to the human situation than the mouse. And particularly, I think, as you say, the surprises which have come were even where the genetic background of these very inbred mouse lines seems to affect the potency of the capsid to achieve, you know, for example, blood-brain barrier penetration. So I think it's yet to be, you know, the hypothesis that the non-human primate selection of base, selection of capsids will more optimally translate in human situations is yet to be validated. But I think what we're confident now, particularly using the TRACER system, is that we can at least use tissue that's closer to the human situation for evolution and selection of capsids, and we can do that efficiently and in quite a fast way to select for the characteristics that we're looking for. And we're looking forward to, you know, bringing these forward into the clinic and really being able to confirm the hypothesis that this is a superior approach than selection in rodent species.
Whether genetic backgrounds, and see sorry, I'm, Brett mass lines and it seems to affect the potency of the cap. So to achieve you know for example, dumping barrier penetration. So I think it's yet to be you know they.
The hypothesis that the non human primate as selection if they sell a selection of Capsense will have more optimally translation hit human situation is yet to be validated, but I think what we're confident now, particularly using the traces system is that we can at least Hughes.
Tissue, that's closer to the human situation Fool evolution, then selection of Capsids, but that we can do that efficiently and in quite a fast way to select the characteristics that were looking for and we're we're looking forward to bringing these fluid into the clinic and really being able to confirm the hypothesis that this is a superior approach and selection then a rodent species.
Omar Khawaja: Okay, great. Thank you. Thanks, Tom.
Okay, great. Thank you.
Thanks, Tom.
Christopher Mirai: Thank you. And our next question comes from Christopher Mirai with Nomura. Your line is now open. Well, hey, good morning.
Thank you and our next question comes from Christopher Marinac with Nomura. Your line is now open.
Oh, Hey, good morning, Thank you for taking my question.
Christopher Mirai: Thank you for taking the question. I'm just thinking about, you know, the upcoming INDs and specifically Huntington's, you know, how should we think about or where are you guys on manufacturing the product? And would you be planning on going into the clinic with your commercial product process, or do you expect to be making changes, you know, after the initial trial is run? Thank you.
Just thinking about.
The upcoming I. MTS and specifically Huntingtons you know how should we think about what or where are you guys on car manufacturing product and would you be planning on going into the clinic with your commercial product process or do you expect to be making changes.
After.
The initial lot trial, it's Ron Thank you.
Matthew Baron Hershenhorn: Thanks, Chris. I'll ask Matt Otmer to answer your question.
Yeah, Thanks, Chris I'll ask Matt off Mary to answer your question Hi, Chris.
Matthew Baron Hershenhorn: Hi Chris. So, as we've covered before, our manufacturing strategy with the group run by Luis Marenga is to really focus on the bacula platform, which gives us a lot of flexibility and confidence as we make the jump from preclinical to the clinic. With the productivity of that process and the robustness of moving to something that we feel we could move across scales and to different manufacturers, our intent as we move into clinical is that it's a process that would be very, very similar to what we would eventually commercialize. We would not want to have to make changes that would require any step back in the future.
So I think as we've covered before our manufacturing strategy with the group right by movie Marette Luis Miranda is to really focus on the Bachelor platform, which gives us a lot of flexibility and confidence as we make the jump from preclinical into the clinic.
Uh huh with the productivity of that process and the robustness of moving to something that we feel we could move a cross scales into different manufacturers.
Our intent as we move into clinical is that it's a process that would be very very similar to what we would eventually commercialize we would not want to have to make changes that would require any step back in the future. So when we select that final process. It has to meet that standard.
Matthew Baron Hershenhorn: So when we select that final process, it has to meet that standard. There is, of course, always the opportunity to optimize the conditions and the way you run it in the future. And again, the investment we've made at the preclinical stage across multiple programs gives us confidence that we can do that within the defined process space. And so as we prepare for the IMD filing, I think we're executing against that plan similarly to what we did with a higher hurdle on the Parkinson's program where we made a change from one process to another. It's very dependent on your analytical capability, which we've also invested in so that we have high confidence in the characterization and the process parameters. So, we are making good progress on that. Okay, so, Are you thinking that you're going to change it after moving into the clinic? I mean, on that continuous program specifically, or not? Thank you. We do not anticipate any changes that we would need to make.
There is of course always the opportunity to optimize the conditions and the way you run it in the future.
And again the investment we've made to preclinical stage across multiple programs yes.
Gives us confidence that we can do that.
Within the defined process space.
And so as we prepare for the island D filing.
Yeah, I think we're executing against that plan.
Similarly to what we did.
Actually with a higher hurdle one the Parkinson's program, where we made a change from one process to another it's very dependent on your analytical capability, which we've also invested in so that we have a high confidence in the characterization the process parameters.
So making good progress on that please.
Okay. So so.
I'm, sorry are you thinking that you're going to change it after moving into the clinic I mean on that continuous program specifically or.
Or not.
Thank you.
We would not anticipate any changes that we need to make that theres always the possibility as you advance in the clinic you can do process optimization within narrow parameters that would not be considered so significant that would have any clinical impact.
Matthew Baron Hershenhorn: There's always the possibility as you advance in the clinic that you can do process optimization within narrow parameters that would not be considered so significant they would have any clinical impact. That's part of when you validate your process, demonstrating that when you move towards your BLA. And so you have to have a process you have high confidence in as you go into the clinic, that it is going to be within a manageable range of what you would then validate for your BLA. And we have that confidence.
That's part of when you validate your process demonstrating that when you move towards you Peel away and so you have to have a process you have high confidence as you go into the clinic that it is going to be within.
A manageable range of what you within validate for your be away and we have that confidence at this point.
Christopher Mirai: Got it. Thank you. Thank you, and as a reminder, ladies and gentlemen, that's star number one to ask a question. Our next question comes from Jeff Hung with Morgan Stanley. Your line is now open.
Got it thank you.
Thank you and as a reminder, ladies and gentlemen that Star then one to ask a question. Our next question comes from Jeff Hong with Morgan Stanley . Your line is now open.
Jeff Hung: Thanks for taking the questions. For Huntington's, you've said that greater than 40% knockdown of HDT results in a significant functional benefit in mice. So what magnitude of knockdown do you think you need to see in humans to translate into a clinically meaningful benefit?
Thanks for taking the questions for Huntingtons, you've said that a greater than 40% knockdown of Institute results in US everyone functional benefit in mice. So what magnitude of knock down do you think you need human.
Ladies into a clinically meaningful benefit.
Yep, Thanks, Jeff Omar will answer your question.
Omar Khawaja: Yep, thanks Jeff. Omar will answer your question.
Yeah again, I think it's somewhat of an unknown I mean, the limitation really get the feel this that they add preclinical efficacy data is based on behavioral readouts from a transgenic animals today. It takes a transgenic rodents wonderful challenge has been that many of these transgenic models don't show never generation and in the same way that.
Omar Khawaja: Yeah, again, I think it's somewhat of a unknown. I mean, the limitation really in the field is that the preclinical efficacy data is based on behavioral readouts from transgenic animals, particularly transgenic rodents. One of the challenges has been that many of these transgenics models don't show neurodegeneration in the same way that, you know, seen in the human situation. And so I think what we're focused on is using the best evidence based on non-clinical behavioral experiments on efficacy, and then modeling those forward from, you know, essentially determining what level of knockdown is necessary to give a clinical benefit in these transgenic species, and then making sure that that sets the minimum threshold for the degree of knockdown as based on the mRNA and protein levels in the non-human primates, and then model that forward to what doses we think are necessary to achieve similar levels of knockdown in the human brain.
You know you've seen in the human situation and so I think what we're focused on is using the best evidence based on.
Uh huh.
Nonclinical add behavioral experiments on efficacy and then modeling that those forward from.
Essentially this happening what level of knockdown is necessary to get the clinical benefits in these transgenic species, and then making sure that that sets the minimum threshold for a pedigree of knockdown as as based on the M&A and protein levels in the non human Primate and then model that forward to what doses. We think is necessary to achieve similar levels, if not down into human brain.
Omar Khawaja: You know, I think that we'll be watching the field very closely, particularly data that's emerging from competitive programs in both gene therapy as well as other modalities such as the anti-sense program, and making sure that we adjust to that. In phase one, though, we plan to explore, you know, a good range of doses, really those starting with what we believe will be at least a minimally clinically efficacious dose as the first dose that's taken into patients.
Yes, I think that will be watching the feel very closely I'm 60 data that's emerging from a competitive programs and in both gene therapy as well as other modalities, such as the antisense pipeline and and making sure that we adjust to that in a phase one that we plan to explore.
A good range of studies says really very starting with what we believe will be at least a minimally clinically efficacious dose as the first dose that's taken into patients.
Omar Khawaja: Great, thanks. And you mentioned non-human primates, so maybe if I can ask a little bit more on that. So, you've shown HTT lowering in different parts of the brain in non-human primates. So, does the threshold for HTT lowering translating to a clinically meaningful benefit vary by location in the brain?
Great. Thanks, and then you mentioned the nine may permit so maybe if I can ask a little more on that so you've shown the HCT lowering in different parts of the brain in non human primates. So just threshold for HCT lowering translating to a clinically meaningful benefit vary by location in the brain.
Yes, it seems to I think again, it's it it comes back to the child until the actual progression as opposed to it in the in the.
Omar Khawaja: Yes, it seems to I think again, it's, it's, it comes back to the challenge of the actual progression of pathology in the in animal models. Obviously, the non-human primate studies are animals that don't, you know, that essentially we're just taking down their wild type Huntington, they don't have reason to be. So for there, we're really looking at knockdown that at least is going to be safe. And that's achievable based on the knockdown that's necessary for recovery in the rodent species, in the transgenic rodent species. So that's really the best we can do. It does seem, however, from the combination of preclinical models that there is variability in the degree of knockdown depending on the part of the brain you're focusing on, cortex versus striatum, for example, and that, you know, probably higher levels of knockdown are necessary in the striatum than in the cortex, but that both are needed.
In animal models. So obviously, the non human primate studies or animals that day that you know that essentially were just taking down a bad.
Well I don't think that they didn't have these in Huntington. So for that we are really looking at not found that at least is going to be safe and that's achievable based on cannot down that's necessary for a recovery and a and the rodent species in the transgenic right in species. So.
That's really out of the best we can to it does seem however that from that combination in preclinical models that there is variability in the degree if not down depending on the as you know that with which parts of the brain, you'll focusing call I'm in a quarter expenses as try some for example, and that Hey, you guys probably high levels of knockdown are necessary in this price and then in the cortex, but that both are needed.
Great. Thank you.
Omar Khawaja: And our next question comes from Sumant Kulkarni with Canaccord. Your line is now open. Good morning.
Thank you and our next question comes from Smart Kulkarni with Canaccord. Your line is now open.
Sumant Satchidanand Kulkarni: Thanks for taking my questions. My question is specifically about what you have termed your tracer program capsids that cross the blood-brain barrier with manifold improved transduction and potentially better self-specificity. What might be the first program that gets into the clinic that uses this tracer technology, and how far away is that? And are these capsids part of the AbbVie vectorized antibody program or farther down the line?
Good morning, Thanks for taking my questions. My question, specifically on what you've done with your tree. So program Capsids that cross the blood brain barrier with men afford improve construction and potentially better cell specificity what might be the first program that gets into the clinic that uses the streets that technology and how far are we is that an IDE. These gaps it's part of the Abbvie back traded antibody program or farther down the line.
Uh huh.
Andre: Thanks, Sumant. As we said in the earlier part of the call, we are the traitor program, and we've already started to present data from that, and that's proceeding apace. We're using it to select vectors and define vectors with different characteristics, both cell type specificity as well as other. For example, the degree of blood-brain barrier penetration and how that can be achieved by ROOT, likely vectors that are emerging from our capsid evolution strategy.
Thanks, Jim on the.
As I as he sat in that other parts of the cool that we are at that type of program that we've already started to present data from that and that that is proceeding apace and we using it to select sectors and add to find access with different characteristics by sell side specificity as well as other.
Uh huh.
Other characteristics for example to grant blood brain barrier penetration and how that can be achieved by by route.
Likely the fact is that how are emerging from a cap city solution strategy.
Andre: Perhaps one of the first programs that we may see that deployed is in our Friedrichs ataxia program. And then, as we also said, we're considering a number of new targets, both with Neurocrin as well as Voyager's own targets. And we'll definitely be using the results of the capsid evolution from the TRACE program to take those targets forward, and look forward to talking about that at a later date. Thank you.
Perhaps one of the first program. So we may see that deployed if they're not Friedreichs ataxia program and then as we also said we're considering a number of new targets, both with no question as well as that voyage around.
Targets, and we'll be definitely and using the results of that capacity solution from foam to try some programs to take those targets forward and look forward to talking about that like today.
Thank you.
Thank you.
Andre Tarrant: And I am not showing any further questions at this time. I would now like to turn the call back over to Andre Tarrant for any closing remarks.
And I'm not showing any further questions at this time I would now like to turn the call back over to Andre Toronto for any closing remarks.
Andre Tarrant: Thanks, Operator. And thank you, everyone, for joining our call today. Just before we wrap up, I'd like to thank Perry Carson and Diana Tsao. As we noted in this morning's release, Perry has provided us notice that he is resigning from our Board of Directors, effective August 31st. Perry is joining the Stanford Distinguished Careers Institute as a fellow, and given the time constraints of that, will no longer serve on our Board, effective at the end of the month. And, as also noted previously, Diana has retired as our Chief Scientific Officer but will continue to consult with us and advise us, including as part of our SAB. So I just wanted to, again, thank them and wish them both the best of luck. And I look forward to updating all of you on our progress again next quarter and, as we see you between now and then, Thank you.
Thanks, operator, and thank you everyone for joining our call today, just before we wrap up the wrap up I'd like to thank Perry Carson and dinosaur as we noted in this mornings release various provide us noticed that he's resigning from our board of directors effective.
August 31st areas, joining the Stanford Distinguished careers Institute does a fellow.
And given the time constraints of that will no longer serve on our board effective at the end of the month.
And as also noted previously Dinos retired as our Chief Scientific officer, but we'll continue to consult with us and advise us.
Getting as part of our FCB. So just wanted to again, thank them and wish them, both the best of luck and.
I look forward to updating all of you on our progress again next quarter and as we see you between now and then thank you.
Ladies and gentlemen, thank you for participating in today's conference. This concludes today's program and you may all disconnect everyone have a wonderful day.
unknown: Ladies and gentlemen, thank you for participating in today's conference. This concludes today's program, and you may all disconnect. Everyone have a wonderful day.
unknown: .......