Q3 2025 Taysha Gene Therapies Inc Earnings Call

Your patients please continue to standby.

[music].

Good day, everyone and welcome to the patient gene therapies third quarter 'twenty 25 earnings call. At this time, all participants are in a listen only mode.

You will have the opportunity to ask questions. During the question and answer session.

You May register to ask a question at any time by pressing the star one on your telephone keypad, you may withdraw yourself from the queue by pressing star and two please.

Please note this call maybe recorded and I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Hayley Collins. Please go ahead.

Operator: It is now my pleasure to turn the conference over to Hayleigh Collins. Please go ahead.

Hayleigh Collins: Thank you. Good morning and welcome to our Q3 2025 Financial Results and Corporate Update Call. Earlier today, Taysha issued a press release announcing financial results for the Q3 ended 30 September 2025. A copy of this press release is available on the company's website and through our SEC filings. Joining me on today's call are Sean Nolan, Taysha's Chief Executive Officer, Sukumar Nagendran, President and Head of R&D, and Kamran Alam, Chief Financial Officer.

Thank you good morning, and welcome to our third quarter 2025 financial results and corporate update call earlier today <unk> issued a press release announcing financial results for the third quarter ended September 30 of 2025.

A copy of this press release is available on the company's website and through our SEC filings.

With me on today's call are Sean Nolan Tatius, Chief Executive Officer, Steve Good morning, Dan Dupree, President and head of R&D and camera long Chief Financial Officer.

Hayleigh Collins: We will hold a question and answer session following our prepared remarks. On today's call, we will be making forward-looking statements, including statements concerning the potential of TSHA-102, including the reproducibility and durability of any favorable results initially seen in patients dosed to date in clinical trials, including with respect to functional milestones to positively impact quality of life and alter the course of disease in the patients we seek to treat. Our research, development, and regulatory plans for our product candidates, including the timing of initiating additional trials, reporting data from our clinical trials, and making regulatory submissions. Timing or outcomes of communications with the FDA on the regulatory pathway for TSHA-102. The potential for the product candidate to receive regulatory approval from the FDA or equivalent regulatory agencies.

We will hold a question and answer session following our prepared remarks.

On today's call, we won't be making forward looking statements, including statements concerning the potential. It takes you 102, including the reproducibility and durability of any favorable results initially seen in patients dosed to date in clinical trials, including with respect to functional milestones to positively impact quality of life and alter the course of disease and the pay.

We seek to treat our research development and regulatory plans for product candidates.

Timing of initiating additional trials reporting data from our clinical trials and making regulatory submissions.

Her outcomes of communications with the FDA on the regulatory pathway for tissue I wanted to.

Hi, Shaul for the product candidate to receive regulatory approval from the FDA or equivalent regulatory agencies, our ability to realize the benefits of breakthrough therapy designation for tissue wanted too and the market opportunity for our program.

Hayleigh Collins: Our ability to realize the benefits of Breakthrough Therapy designation for TSHA-102, and the market opportunity for our program. This call may also contain forward-looking statements relating to Taysha's growth, forecasted cash runway and future operating results, discovery and development of product candidates, strategic alliances, and intellectual property, as well as matters that are not historical facts or information. Various risks may cause Taysha's actual results to differ materially from those stated or implied in such forward-looking statements. For a list and description of the risks and uncertainties that we face, please see the reports that we have filed with the SEC, including in our annual report on Form 10-K for the full year 31 December 2024, that we filed 26 February 2025. In our quarterly report on Form 10-Q for the quarter ended 30 September 2025, that we filed today.

This call May also contain forward looking statements relating to <unk> growth.

Forecast for cash runway in future operating results discovery and development of product candidates strategic alliances and intellectual property as well as matters that are not historical facts or information.

These risks may cause <unk> actual results to differ materially from those stated or implied in such forward looking statements.

And description of the risks and uncertainties that we face. Please see the reports that we have filed with the SEC, including our annual report on Form 10-K for the full.

All year December 31, 2024 that we filed February 26 2025.

Our quarterly report on Form 10-Q for the quarter ended September 30th 2025 that we filed today. This conference call contains time sensitive information, but is accurate only as of the date of this live broadcast November 4th 2025.

Hayleigh Collins: This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, 4 November 2025. Taysha undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as may be required by applicable securities laws. I would now like to turn the call over to our CEO, Sean Nolan.

Hey, Sean undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this conference call, except as may be required by applicable securities laws.

I would now like to turn the call over to our CEO Sean Mullen.

Sean Nolan: Thank you, Hayleigh, welcome everyone to our Q3 conference call. I will begin with an update of our recent corporate activities and progress across our TSHA-102 Rett syndrome program. Suku will then discuss the new supplemental analysis from Part A of our REVEAL phase I/II trials. Kamran will follow up with a financial update, and I will provide closing remarks before opening the call to questions. In the quarter, we believe we made meaningful progress that sets the stage for what could be a transformative period ahead for Taysha. The recent regulatory clarity and progress we've achieved, which was enabled by the strength of our REVEAL Part A data set, rigorous data evaluation methodology, and our natural history data analysis, allows us to focus on executing our REVEAL pivotal trial and advancing towards BLA submission with clarity and confidence.

Thank you Haley and welcome everyone to our third quarter conference call I will begin with an update of our recent corporate activities and progress across our tissue at one or two ret syndrome program.

<unk> will then discuss the new supplemental analysis from part a of our reveal phase one two trials camera will follow up with the financial update and I will provide closing remarks before opening the call to questions.

In the quarter.

We believe we've made meaningful progress that sets the stage for what could be a transformative period ahead for tisha. The recent regulatory clarity and progress we've achieved which was enabled by the strength of our reveal party dataset rigorous data evaluation methodology.

And our natural history data analysis allows us to focus on executing our reveal pivotal trial and advancing towards BLA submission with clarity and confidence are.

Sean Nolan: A major milestone was the receipt of FDA Breakthrough Therapy designation for TSHA-102 at the end of September. This designation is designed to expedite the development and review of therapies for serious conditions that have demonstrated preliminary clinical evidence of substantial improvement over available treatments in one or more clinically meaningful endpoints. TSHA-102 received Breakthrough Therapy designation based on the FDA's review of available safety and efficacy data from all 12 pediatric, adolescent, and adult patients treated with TSHA-102 in Part A of our REVEAL phase I/II trials, including clinical data from the previously disclosed May 2020, 2025 data cutoff.

A major milestone was the receipt of FDA breakthrough therapy designation for Tisha 102 at the end of September.

This designation is designed to expedite the development and review of therapies for serious conditions that have demonstrated preliminary clinical evidence of substantial improvement over available treatments and one or more clinically meaningful endpoints.

Chase you want them to receive breakthrough therapy designation based on the Fda's review of the available safety and efficacy data from all 12, pediatric adolescent and adult patients treated with Taishan 102, and part a of our reveal phase one two trials, including clinical data from the previously disclosed may 2020.

2025 data cutoff.

Sean Nolan: Receiving breakthrough designation highlights the FDA's recognition of both the significant unmet medical need among the estimated 10,000 patients suffering from Rett syndrome in the US and the therapeutic potential of TSHA-102 to redefine the treatment paradigm for this devastating disease. Over 80% of programs with Breakthrough Therapy designation that proceeded to file for approval have ultimately received FDA approval. We look forward to continued engagement with the FDA as we advance toward potential registration. In September, we finalized alignment with FDA on our REVEAL pivotal trial protocol and statistical analysis plan in support of our planned BLA submission for TSHA-102 following resolution of remaining clinical and statistical queries. Our previously aligned upon key design elements remain unchanged.

Receiving breakthrough designation highlights the fda's recognition of both the significant unmet medical need among the estimated 10000 patients suffering from ret syndrome in the U S.

The therapeutic potential of <unk> 102 to redefine the treatment paradigm for this devastating disease, notably over 80% of programs with breakthrough therapy designation that preceded the file for approval have ultimately received FDA approval, we look forward to continuing engagement with the FDA as we.

Lance towards potential registration.

In September we finalized alignment with FDA and are revealed pivotal trial protocol and statistical analysis plan in support of our planned BLA submission for <unk> 102.

Following resolution of remaining clinical and statistical queries.

Importantly, our.

Our previously aligned upon key design elements remain unchanged.

Sean Nolan: In line with FDA's guidance for cell and gene therapy programs that was issued in September, we believe that by prospectively aligning with FDA on the statistical analysis plan for our pivotal trial helps ensure that the dataset collected will be considered reliable and suitable for BLA submission. We are enrolling 15 patients in the developmental plateau population of Rett syndrome with a primary endpoint of response rate, which is defined as the percentage of patients who gain or regain one or more of the 28 natural history-defined developmental milestones. A response rate of 33%, equivalent to 5 out of 15 patients, is the minimum threshold for success sufficient to achieve our primary endpoint. Notably, we've observed a 100% response rate across the 10 patients in Part A of our REVEAL trials.

In line with the Fda's guidance for cell and gene therapy programs that was issued in September we believe that the prospectively aligned by that by prospectively aligning with FDA on the statistical analysis plan for our pivotal trial helps ensure that the dataset collected will be considered a reliable and suitable for BLA submission.

Mission.

We are enrolling 15 patients in the developmental plateau population of Ret syndrome.

The primary endpoint of response rate, which is defined as the percentage of patients who gain or regain one or more of the 28 natural history defined adult developmental milestones.

Response rate of 33% equivalent to five out of 15 patients as the minimum threshold for success sufficient to achieve our primary endpoint.

Notably we've observed 100% response rate across the 10 patients in part a of our reveal trials.

Sean Nolan: Additionally, we align with the FDA on a 6-month interim analysis that may serve as the basis for BLA submission, potentially accelerating our planned BLA submission by at least 2 quarters. As previously disclosed, the data from Part A of the REVEAL trials demonstrated an 83% response rate at 6 months post-treatment, with 5 of the 6 patients treated with the high-dose TSHA-102 achieving a developmental milestone. We observed a consistent pattern of sustained milestone gains with a deepening of effect or additional milestone gains over time. By 9 months post-treatment, the data demonstrated a 100% response rate across the 6 treated high-dose patients in Part A. We believe these data support both the suitability of the 6-month time point to demonstrate clinically meaningful efficacy and that the 6-month efficacy data may be representative of treatment effects at 12 months.

Additionally, we align with the FDA on a six month interim analysis analysis that may serve as the basis for BLA submission potentially accelerating our planned BLA submission by at least two quarters.

As previously disclosed the data from part a of the reveal trials demonstrated an 83% response rate at six months post treatment with five of the six patients treated with the high dose <unk> 102, achieving a developmental milestone.

We observed a consistent pattern of sustained milestone gains with the deepening of effect.

Or additional milestone gains over time.

By nine months post treatment the data demonstrated a 100% response rate across the six treated high dose patients in part a.

We believe these data support both the suitability of the six month time point to demonstrate clinically meaningful efficacy and that's a six month efficacy data may be representative of treatment effects at 12 months.

Sean Nolan: We believe this enabled our alignment with FDA that a 6-month interim analysis may serve as the basis for BLA submission. It's important to understand that we believe we received Breakthrough Therapy designation and achieved FDA alignment largely due to the results of the rigorous clinical evaluation methodology applied to our video evidence developmental milestone data from Part A of the REVEAL phase I, II trials. In Part A, videos were centrally rated by multiple independent reviewers using milestone definitions from the pivotal trial protocol to ensure an objective, consistent evaluation of milestone gain and regain in the developmental plateau population, where these gains are not expected to spontaneously occur. By adhering to rigorous milestone evaluation criteria based on natural history, this approach minimizes bias and avoids over-counting milestones by ensuring the milestones are truly eligible for gain or regain.

We believe this enabled our alignment with FDA that a six month interim analysis may serve as the basis for BLA submission.

It's important to understand that we believe we received breakthrough therapy designation and achieved FDA alignment largely due to the results of the rigorous clinical evaluation methodology applied to our video evidence developmental milestone data from part a of the reveal phase one two trials.

In part H videos were centrally rated by multiple independent reviewers using milestone definitions from the pivotal trial protocols to ensure an objective consistent devaluation of milestone gain and regain in the developmental plateau population, where these gains are not expected to.

Spontaneously occur.

By adhering to rigorous milestone evaluation criteria based on natural history. This approach minimizes bias and avoids over counting milestones by ensuring the milestones are truly eligible for gain or regain.

Sean Nolan: As a result, this provides a reliable reflection of TSHA-102's disease-modifying therapeutic effect and ensures that the pivotal trial is well-powered to demonstrate efficacy. We will continue to have frequent and consistent interactions with the FDA. We presented our REVEAL Part A data from the May 2025 data cutoff, including the new supplemental analysis, which provides supportive evidence that further reinforce TSHA-102's consistent multi-domain impact on activities of daily living at the Child Neurology Society Annual Meeting in October. Suku will discuss these results shortly. With the strength of our Part A clinical data and a clear FDA-aligned path to potential registration, we believe we are strongly positioned to initiate our REVEAL pivotal trial and accelerate execution towards BLA submission.

As a result, this provides a reliable reflection of tissue one O twos disease, modifying therapeutic effect and ensures that the pivotal trial is well powered to demonstrate efficacy. We will continue to have frequent and consistent interactions with the FDA.

We presented our reveal part a data from the May 2025 data cutoff, including the new supplemental analysis, which provide supportive evidence that further reinforce tisha 100, two's consistent multi domain impact on activities of daily living at the child Neurology Society annual meeting.

In October <unk> will discuss these results shortly.

With the strength of our part a clinical data and a clear F. D. A aligned path to potential registration. We believe we are strongly positioned to initiate our reveal pivotal trial and accelerate execution towards BLA submission.

Sean Nolan: Dosing of the first patient in our REVEAL pivotal trial is scheduled and on track for this quarter, with additional patient enrollment expected to continue across multiple sites this quarter. On the heels of our strong clinical and regulatory progress, we are thrilled to have regained full global rights to our TSHA-102 Rett syndrome program. We regained these rights in October following the expiration of our 2022 option agreement with Astellas, which had granted Astellas an exclusive option to enter into a negotiation period to license TSHA-102 and certain rights with respect to change in control transactions. We appreciate the collaborative relationship we've had with Astellas. The unencumbered rights to TSHA-102 that we now hold enable us to focus on driving long-term value with full strategic flexibility and optionality.

Hosting of the first patient in our reveal pivotal trial is scheduled and on track for this quarter with additional patient enrollment expected to continue across multiple sites this quarter.

On the heels of our strong clinical and regulatory progress. We are thrilled to have regained full global rights to our tissue went onto Ret syndrome program. We regained these rights in October following the expiration of our 2022 option agreement with Astellas.

Which had granted astellas and an exclusive option to enter into a negotiation period to license <unk> 102, and certain rights with respect to change in control transactions. We appreciate the collaborative relationship we have with Astellas in.

And the unencumbered rights to <unk>, one or two that we now hold enable us to focus on driving long term value with full strategic flexibility and optionality.

Sean Nolan: We continue to build out our infrastructure to support advancing TSHA-102 toward late-stage development and potential commercialization, if approved. This September, we strengthened our commercial leadership team with the appointment of David McNinch as Taysha's Chief Commercial Officer. David brings over two decades of experience in global commercialization and strategic market development across multiple therapeutic areas. Most recently, he served as Chief Business Officer at Encoded Therapeutics, where he led the commercial and partnering strategy across the company gene therapy portfolio. He previously held senior commercial roles at Prothena as well as InterMune, where he led the launch of Esbriet, the first FDA-approved treatment for idiopathic pulmonary fibrosis, and supported the company's acquisition by Roche. David reports to Sean McAuliffe, Taysha's Chief Business Officer.

We continue to build out our infrastructure to support advancing Tiatia 102 toward late stage development and potential commercialization. If approved this September we strengthened our commercial leadership team with the appointment of David Mcninch hesitation as Chief Commercial officer, David brings over two decades of <unk>.

Experience in global commercialization and strategic market development across multiple therapeutic areas.

Most recently he served as chief business officer at encoded Therapeutics, where he led the commercial and partnering strategy across the company.

Gene therapy Poli portfolio deep.

He previously held senior commercial roles at proteinuria as well as Intermune, where he led the launch of <unk>. The first FDA approved treatment for idiopathic pulmonary fibrosis and supported the company's acquisition by Roche.

David reports to Sean Mcauliffe.

<unk> Chief business Officer.

Sean Nolan: Previously, at AveXis, Sean led the development and execution of the commercial launch of Zolgensma for spinal muscular atrophy, the first FDA-approved gene therapy for the treatment of a monogenic CNS disease, which has reached blockbuster status. With an estimated 15,000 to 20,000 patients with Rett syndrome across the US, EU, and UK, compelling clinical data from Part A of our REVEAL trials, and a minimally invasive, commercially advantageous delivery approach, we see a significant opportunity to address a profound unmet medical need and drive long-term value. We believe our strong balance sheet, team with proven gene therapy experience, and the clear path to registration strongly position us to initiate our REVEAL pivotal trial and accelerate execution toward BLA submission. I will now turn the call over to Suku to discuss our clinical progress in more detail. Suku?

Previously at Abaxis, Sean loves the development and execution of the commercial launch of <unk> for spinal muscular atrophy. The first FDA approved gene therapy for the treatment of a monogenic CNS disease, which has reached blockbuster status.

With an estimated 15000 to 20000 patients with ret syndrome or cost the U S EU and U K.

Compelling clinical data from part a of our reveal trials in a minimally invasive commercially advantageous delivery approach, we see a significant opportunity to address a profound unmet medical need and drive long term value. We believe our strong balance sheet team with proven gene therapy experience and the <unk>.

<unk> path to registration and strongly position us to initially to initiate our reveal pivotal trial and accelerate execution towards BLA submission I will now turn the call over to <unk> to discuss our clinical progress in more detail <unk>.

Sukumar Nagendran: Thank you, Sean. As Sean mentioned, the regulatory progress we've achieved to date was enabled by the strength of our REVEAL Part A data and our natural history data analysis that allows us to objectively measure developmental milestone gain and regain in the developmental plateau population using each patient as their own control. At the Child Neurology Society Annual Meeting in October, we presented a comprehensive review of our Part A data set using the evaluation frame point and endpoint of our pivotal trial. As previously reported, 100% of the 10 patients in Part A achieved one or more natural history-defined developmental milestones following treatment with TSHA-102, with a consistent pattern of early gains that are sustained and new achievements continuing to emerge over time following TSHA-102 treatment.

Thank you Sean.

As Sean mentioned, the regulatory progress we've achieved today. It was enabled by the strength of the party data and natural history data analysis that allows us to objectively measure developmental milestone gain and regain in the development of plateau population using each patient as their own control.

And the child Neurology Society annual meeting in October we presented a comprehensive review of our party dataset using devaluation framed point and endpoint of our pivotal trial.

As previously reported 100% of the 10 patients in part achieved one or more natural history defined development milestones following treatment with dish on one or two.

System patent number any games that are sustained and new achievements continuing to emerge over time following <unk> treatment.

Sukumar Nagendran: These milestones were all video evidenced and assessed by independent central raters according to the definition of milestone achievement from our pivotal trial protocol. These criteria enabled a reliable, objective, and consistent assessment of TSHA-102's efficacy, and importantly, show that our pivotal trial is well-powered to establish the therapeutic impact of TSHA-102. We presented a new supplemental analysis of REVEAL Part A data that captures supportive evidence of additional skill gains and improvements outside of the 28 natural history-defined milestones. These gains were derived from the adapted Mullen Scales of Early Learning, the Revised Motor-Behavioral Assessment, or RMBA, and the Observer-Reported Communication Ability Assessment, which are revalidated structured assessments that evaluated pre-specified skills and quantifiable improvements.

These milestones were all video evidenced in assessed by independent Central Raters. According to the definition of milestone achievement from our pivotal trial protocol. These.

These criteria in their book are reliable objective and consistent assessment of de Silva not towards efficacy and importantly showed that a pivotal trial is well powered to establish the therapeutic impact of dish on one or two.

Additionally, we presented a new supplemental analysis I'll review, the <unk> data that capture supportive evidence of additional skill gains and improvements outside of the 20th natural history defined milestones. These gains are designed from the adapted mullen scale doubling up.

The revised motor behavior assessment, our RMB and the observer reported communication ability assessment, which are validated structured assessments that evaluated pre specified skills and quantifiable improvements.

Sukumar Nagendran: The results show that in addition to the developmental milestones achieved across the treatment cohort in Part A, patients consistently gained multiple additional skills and improvements in core disease characteristics across the domains of autonomic function, communication, fine motor, and gross motor areas. We believe these findings reinforce the consistent, broad therapeutic impact of TSHA-102 on activities of daily living that are important to caregivers and clinicians. As we continue to prioritize safety, I am pleased to share that TSHA-102 continues to be generally well-tolerated with no treatment-related serious adverse events or dose-limiting toxicities across the 12 pediatric, adolescent, and adult patients treated with the high and low doses of TSHA-102 in Part A of our REVEAL trials as of the October 2025 data cutoff.

The results show that in addition to the development milestones achieved across the treatment cohort in part D patients consistently gain multiple additional skills that improvements in core disease characteristics across the domains of autonomic function communications find motor and gross water area.

We believe these findings reinforce the consistent broad therapeutic impact of the extra one or two on activities of daily living that are important to caregivers and clinicians.

As we continue to prioritize safety I am pleased to share that Tessa one or two continues to be generally well tolerated with no treatment related serious adverse events or dose limiting toxicities across the 12 pediatric adolescent and adult patients treated with the high and low doses of T cell, one or two in potash.

Our reveal trials as of the October 2025 data cutoff.

Sukumar Nagendran: We are encouraged by the data we have collected from Part A of our REVEAL trials, which we believe support the potential of TSHA-102 to provide meaningful benefit to children, adolescents, and adults living with Rett syndrome. We look forward to reporting longer-term Part A clinical data in H1 2026. I will now turn the call over to Kamran to discuss financials. Kamran?

We are encouraged by the data that we've collected from par payoff, our reveal trials, which we believe support the potential of <unk> to provide meaningful benefit to children adolescents and adults living with Ret syndrome.

Forward looking reporting longer term positive clinical data in the first half of 2026.

I will now turn the call over to Cameron to discuss financials Kamran.

Kamran Alam: Thank you, Suku. Research and development expenses were $25.7 million for the 3 months ended 30 September 2025, compared to $14.9 million for the 3 months ended 30 September 2024. The increase was driven by BLA-enabling process performance qualification or PPQ manufacturing initiatives, REVEAL clinical trial activities, and higher compensation expenses as a result of increased headcount during the 3 months ended 30 September 2025. General and administrative expenses were $8.3 million for the 3 months ended 30 September 2025, compared to $7.9 million for the 3 months ended 30 September 2024.

Thank you Sue.

Research and development expenses were $25 $7 million for the three months and.

32025, compared to $14 9 million for the three months ended September 32024.

The increase was driven by a BLA, enabling process performance qualification or PQ manufacturing initiatives reveals clinical trial activity and higher compensation expenses as a result of increased head count during the three months ended September 32025.

General and administrative expenses were $8 $3 million for the three months ended September 32025, compared to $7 9 million for the three months ended September 32024.

Kamran Alam: The increase of $0.4 million was primarily due to debt issuance costs incurred in connection with the refinancing of our existing loan and security agreement with Trinity Capital that are recorded in general and administrative expense under the fair value option and was partially offset by lower legal and professional fees. Net loss for the three months ended 30 September 2025 was $32.7 million or $0.09 per share, compared to a net loss of $25.5 million or $0.10 per share for the three months ended 30 September 2024. As of 30 September 2025, Taysha had $297.3 million in cash and cash equivalents. We expect that our current cash resources will support planned operating expenses and capital requirements into 2028.

The increase of <unk> four.

$4 million was primarily due to debt issuance costs incurred in connection with the refinancing of our existing loan and security agreement with Trinity capital that are recorded in general and administrative expense under the fair value option and was partially offset by lower legal and professional fees.

Net loss for the three months ended September 32025 was $32 $7 million or <unk> <unk> per share compared to a net loss of $25 $5 million or <unk> <unk> per share for the three months ended September 32024.

As of September 32025, Acacia had $297 $3 million in cash and cash equivalents, we expect that our current cash resources will support planned operating expenses and capital requirements into 2028.

Kamran Alam: I will now turn the call over to Sean for his closing remarks. Sean?

I will now turn the call over to Sean for his closing remarks, Sean Thank you Cameron with.

Sean Nolan: Thank you, Kamran. With Breakthrough Therapy designation and finalized FDA alignment, together with our strong balance sheet and full strategic control of TSHA-102, we believe we are entering the pivotal phase of development with focus and confidence in our ability to redefine the treatment landscape for Rett syndrome while driving long-term value. We remain on track to dose the first patient in our REVEAL pivotal trial, with additional enrollment expected sites this quarter. We expect to report longer-term clinical data from Part A of our REVEAL Phase I-II trials in H1 2026. We look forward to providing further updates as we initiate our REVEAL pivotal trial and advance TSHA-102 towards BLA submission. I will now ask the operator to begin our Q&A session. Operator?

With breakthrough therapy designation and finalized FDA alignment together with our strong balance sheet and full strategic control of <unk> 102. We believe we are entering the pivotal phase of development with focus and confidence in our ability to redefine the treatment landscape for ret syndrome, while driving long term value.

We remain on track to dose the first patient in our reveal pivotal trial with additional enrollment expected.

Global sites this quarter.

Additionally, we expect to report longer term clinical data from part a of our reveal phase one two trials in the first half of 2026, we look forward to providing further updates as we initiate our reveal pivotal trial and advanced <unk> 102 towards BLA submission.

I'll now ask the operator to begin our Q&A session operator.

Operator: We do ask that you limit yourself to 1 question per person. We'll take our first question from Kristen Kluska with Cantor. Your line is open.

At this time, if you would like to ask a question. Please press the star and one on your telephone keypad, you may remove yourself from the queue at any time by pressing star two.

Ask that you limit yourself to one question per person.

Once again to ask a question that is star one.

We will take our first question from Christian <unk> with.

Your line is open.

Kristen Kluska: Hi. Good morning, everybody. Thanks so much for taking my question. Just curious, this time around in the pivotal trial, you have a lot more evidence going for you. Can you talk about the pipeline of interest and demand for being in this trial, and then your thoughts about how long it could take to fully enroll?

Hi, good morning, everybody. Thanks, so much for taking my question. Just curious this time around in the pivotal trial you have a lot more evidence going for you. So can you talk about the pipeline of interest and demand for being in this trial and then your thoughts about how long it could take to fully enroll.

Sean Nolan: Sure, Kristen. Thanks for the question. I would say unequivocally that the demand to be in the trial is exceptionally high. I think the fact that we've been, you know, relatively consistently putting out both safety and efficacy data as we have maturation occur in the study and keeping close contact with the advocacy groups, centers of excellence, and KOLs has led to a strong demand. With that as a backdrop, let me just turn it over to Suku to give a little bit more flavor and then maybe just give timeline, you know, parameters around what we expect enrollment could potentially take.

Sure Kristen Thanks for the question.

I would say unequivocally that the demand to be in the trial is exceptionally high.

The fact that we've been.

Relatively consistently putting out both safety and efficacy data as it as we have maturation occur in this study and keeping close contact with the advocacy groups centers of excellence and Kols has led to a strong demand so.

With that as a backdrop, let me just turn it over to sue to give a little bit more flavor and then maybe just give timeline parameters around what we expect enrollment could potentially take.

Sukumar Nagendran: Thanks for that question, Kristen. As Sean highlighted, we have multiple sites, more than 15 sites identified for our clinical trials program, Part B. All of these sites are at centers of excellence. Very interestingly, many of these sites have 100-plus patients per site who have the diagnosis of Rett syndrome, and many of these patients could qualify for our Part B trial. This includes pediatric, adolescent, and adult patients who will be part of the process. Furthermore, let me highlight that in the best-case scenario, we could potentially enroll and recruit all 15 patients within a 3-month time period, and a more conservative timeline could be between 3 to 6 months.

Thanks for that question Kristen.

As John highlighted.

We have multiple sites more than 15 sites identified for our clinical trials program part B all of these sites outlet centers of excellence and interestingly. Many of these sites have hundred cost patients per site.

The diagnosis of a syndrome and many of these patients could qualify for a part B trial and this includes pediatric adolescent and adult patients who will be part of the process now on the Furthermore, let me highlight that.

In the best case scenario, we could potentially enroll and record all 15 patients within a three month time period, and a more conservative timeline could be between three to six months and as I said many of these sites already have multiple patients identified and there's significant interest in our gene therapy program due to the efficacy already on safety.

Sukumar Nagendran: As I said, many of these sites already have multiple patients identified and there's significant interest in our gene therapy program due to the efficacy already and safety already disclosed in the Part A trial and the ease of route of administration that we have to deliver a gene therapy that already shows significant clinical impact. Thank you.

You already disclosed the partner trial and the Eastern route of administration that we have to.

To deliver a gene therapy that already shows significant clinical impact. Thank you.

Sean Nolan: Yeah, maybe just one more thing to add. We highlighted it in the press release, but, you know, to Suku's point, you know, we've got dosing schedules, you know, for the first patient, you know, already scheduled this quarter, and we expect other patients to enroll at multiple sites this quarter as well. I think that speaks to both the demand and the alacrity at which the sites have worked to initiate the pivotal trial.

And maybe just one more thing to add we highlighted in the press release, but you have to.

<unk> point, we're we've got dosing schedules.

For the first patient.

Scheduled this quarter and we expect other patients to enroll at multiple sites this quarter as well. So I think that speaks to both the demand and the alacrity at which the sites have worked to initiate the pivotal trial and then one more point I should emphasize is many of these sites maybe at most a dose more than one patient.

Sukumar Nagendran: You know, Kristen, one more point I should emphasize is many of these sites may be able to dose more than one patient in kind of a staggered parallel fashion. We might be able to get one, two, or three patients two, three weeks apart at some of these sites, which would further accelerate our timelines and hopefully make the submission of the BLA timeline even shorter and make this product available to deserving patients who have Rett syndrome.

And kind of a staggered parallel fashion, so we might be able to get one two or three patients two or three weeks apart. Some of these sites, which would further accelerate our timelines and hopefully make the submission of the BLA timeline, one charter and make this product available to does that mean patients who have ret syndrome.

[Analyst]: Thank you.

Thank you.

Operator: Our next question comes from Salveen Richter with Goldman Sachs. Your line is open.

Our next question comes from Sylvan Richter with Goldman Sachs. Your line is open.

Salveen Richter: Good morning. Thanks for taking my question. I was just wondering if you could touch on expectations for the longer-term data in H1 of next year. Also, you know, help us understand in the context of your discussions with the FDA, what they have signed off on in terms of that, you know, minimum threshold for success here that's sufficient for filing. Thank you.

Good morning, Thanks for taking my question I was just wondering if you could touch on expectations for the longer term data.

Sorry in the first half of next year.

And also help us understand in the context of your discussions with the FDA.

What they have signed off on in terms of that minimum threshold for success here that's sufficient for filing thank you.

Sean Nolan: Thanks for the question, Salveen. For the first part of the question relative to, you know, what updates will be given the H1 of next year, I think it'll be consistent with what you've seen. You know, as the data matures, we've tried to look at things as a full cohort. Ultimately, we wanna get to we have all 12 patients at 12 months. I think that'll be very important, you know, data to look at, you know, relative to the 6-month time point, where are we at 12 months with these patients? We'll do that. In addition to that, I think it's important to continue to provide updates relative to the safety profile.

Thanks for the question <unk>.

For the first part of the question relative to what updates will be given the first half of next year I think it'll be consistent with what you've seen.

As the data matures, we've tried to look at things as a whole cohort.

So ultimately we want to get too we have all 12 patients at 12 months.

And I think that'll be very important.

Data to look at relative to the six month time point, where are we at 12 months with these patients.

And so we will do that.

Additional to that I think it is important to continue to provide updates relative to the safety profile. So we went a little bit of flexibility here.

Sean Nolan: You know, we want a little bit of flexibility here that, you know, we could potentially give an update in Q1 with, you know, almost 12 months of data. We could wait for Q2. We wanna, we just wanna make sure that the market's aware of the fact that we do plan to give, you know, further updates both in terms of safety and efficacy that we think will be very enlightening and informative relative to the predictability of the approval of the pivotal trial. That's number 1.

We could potentially give an update in the first quarter with almost 12 months of data we could do we could wait for the second quarter, but we want to we would just want to make sure that the market's aware of the fact that we do plan to give.

Further updates both in terms of safety and efficacy that we think will be very enlightening and informative informative relative to the predictability of the approval of the pivotal trial. So that's number one number two I guess.

Sean Nolan: Number two, I, as it relates to FDA alignment, you know, we highlighted in the script, and, you know, I think it's really important that, you know, back in September, the FDA put out guidance that's very consistent with everything we've done to date in our interactions with them, which is very specifically, they want alignment on your SAP before you start your clinical trial. Like, that is the highly recommended path to take. That's exactly what we've done. You know, we submitted the SAP going back as far as January, when we got the okay to go ahead and submit the final SAP and the clinical protocol by the end of Q2 without an end of phase meeting. We did that. We've answered all the then subsequent queries from the statistical analysis plan question and clinical questions.

As it relates to FDA alignment.

We highlighted in the script and I think it's really important that unit back in September the FDA put out guidance.

That's very consistent with everything we've done to date and our interactions with them, which is very specifically they want alignment on your Asap before you start your clinical trial like that is the highly recommended path to take.

And that's exactly what we've done we submitted the SAP going back as far as January.

When we got the Okay to go ahead and submit the file.

And the clinical protocol by the end of the second quarter without a end of phase meeting.

Did that.

We've answered all of the subsequent queries from the statistical analysis plan question and clinical questions and we actually even reached out to the FDA.

Sean Nolan: We actually even, you know, reached out to the FDA because we had believed we'd answered all their questions, and we sent them a note and said, We just wanna confirm that there's no other outstanding statistical or clinical questions. They said, Confirmed. We feel everything that we've just presented, you know, with the NF 15, the threshold of a responder being, you know, the gain or regain of 1 milestone and crossing the threshold of having a 33% response rate all ties to the statistical plan that we've submitted. We feel we're very much in alignment with the FDA.

Because we believe we've answered all their questions and we sent them a note and said we just want to confirm that there is no other outstanding statistical or clinical questions and they've said confirmed so we feel everything that we've just presented with the end of 15, the threshold of a responder being a gain of <unk>.

One milestone and crossing the threshold of having a 33% response rate all ties to the statistical plan that we've submitted so we feel were very much in alignment with the FDA.

Sean Nolan: The other thing I would just note is that, you know, per the FDA's, you know, internal SOPs, you know, these milestone meetings where you're talking about, you know, the final protocol, the SAP, you know, internally the directors are at those meetings. So I can't give you specific names who are there, but that is the protocol. We feel, you know, again, supremely confident at this particular point in time. We've done everything that this FDA, you know, has asked us to do. We've been in full alignment with them the entire way. I would argue we were in full alignment with the Peter Marks regime as well, and I think that's all because of the integrity of the data and the quality and rigor of the data collection that we've put forward.

The other thing I would just note is that per the Fda's internal S op.

These milestone meetings, where you were talking about.

The final protocol the SAP.

Internally the directors are at those meetings.

I can't give you specific names who are there but that is the protocol. So we feel again supremely confident at this particular point in time, we've done everything that the FDA has asked us to do we've been in full alignment with on the entire way and I would argue we were in full alignment with the Peter marks version.

Jim as well and I think that's all because of the integrity of the data and the quality and rigor of the data collection that we've put forward. So we think we've checked all the boxes, we've double checked and we're told we're good to go and that's why it's full steam ahead on patient enrollment right now.

Sean Nolan: We think we've checked all the boxes, we've double-checked, and we're told we're good to go, and that's why it's full steam ahead on patient enrollment right now.

Salveen Richter: Thank you.

Thank you.

Sean Nolan: Thank you.

Thank you.

Operator: Our next question comes from Tazeen Ahmad with Bank of America. Your line is open.

Our next question comes from Cucina Mod with Bank of America. Your line is open.

Tazeen Ahmad: Hi, guys. Good morning. Thanks for taking my question. I wanted to get a little bit more color on how you're thinking about the way we should all be thinking about the data from the younger patients, meaning the 2 to 6-year-olds, relative to the 6-plus-year-olds as it relates to efficacy in particular. On safety, should we be expecting to see a staggered release of safety data on that younger population relative to the older population? Basically, when could we expect to see data start to come in from that cohort base? Thanks.

Hi, guys. Good morning, Thanks for taking my question.

Wanted to get a little bit more color on how you're thinking about the way we should all be thinking about the data from the younger patients, meaning the two the six year old relative to the six plus year olds answer really.

<unk> in particular, and then on safety.

We are expecting to see a staggered release of safety data on that younger population relative to the older population.

When can we expect to see data starts to come in from that cohort.

Sean Nolan: Yeah, sure. Thanks for the questions, Tazeen. Number 1, I think the headline is our goal is to ensure that by the time we submit the BLA under any circumstance that these 2 to 5-year-old population's included in that, okay? That we would have a, you know, a very broad, you know, 2 plus label effectively. The way we're stepping through that is this quarter we're in, we'll be having dialogue with the FDA. You know, we've submitted the protocol to them, we'll be getting some feedback, you know, on that. It is a safety-focused study. We have had discussions with the FDA, formal meetings with the FDA, where we've basically made the following request, that for this population, we wanna establish safety, number 1.

Yes sure. Thanks.

Thanks for the questions chasing number one I think the headline is our goal is to ensure that by the time, we submit the BLA under any circumstance.

As to the.

Five year old population included in that Okay. So that we would have a very broad two plus label effectively and so the way we're stepping through that is this quarter. We're in we will be having dialogue with the FDA. We've submitted the protocol to them. So we'll be getting some feedback.

On that.

It is a safety focus study.

We have had discussions with the FDA formal meetings with the FDA, where we basically made the following request.

So for this population we want to establish safety number one.

Sean Nolan: We will collect some efficacy data, of course, but what we proposed was that we could extrapolate efficacy from the 6 plus population and that that would be sufficient for, you know, getting this younger group into the label, and the FDA agreed to that. That's how we're gonna step through it. We would anticipate, you know, beginning to dose these patients, you know, once we have alignment with the FDA, probably towards the middle of 2026. Again, because it's safety, we think the trains will align on time in terms of BLA submissions, and then we'll follow, you know, efficacy over the course of time in this patient population to see, you know, if there's things that are unique there. If appropriate, you know, we could certainly update the label with any new data we have.

We will collect some efficacy data of course.

But what we've proposed was that we could extrapolate efficacy from the six plus population and that that would be sufficient for getting this younger group into the label.

And the FDA agreed to that.

So that's how we're going to step through it we would we would anticipate beginning to dose. These patients once we have alignment with the FDA is probably towards the middle of 2026.

Again, because it's safety, we think the trains will align on time in terms of BLA submissions and then we will follow.

Efficacy over the course of time in this patient population to see if.

If there's things that are unique there.

Appropriate we could certainly update the label with any new data, we have but again to just restate the primary goal.

Sean Nolan: Again, to just restate the primary goal, it's that at approval you would have a label of 2 plus with no, you know, specific constraints relative to efficacy that's been collected. It's the whole population that you're getting approval on.

At at approval you would have a label of <unk> II plus with with no specific constraints relative to efficacy. That's been collected it's the whole population that youre getting approval on.

Okay.

Operator: Our next question comes from Gil Blum with Needham & Company. Your line is open.

Our next question comes from Gil Blum with Needham <unk> Company. Your line is open.

Gil Blum: Good morning, and thanks for taking our question. Maybe just another one on protocols here. How much leeway do you think the agency provides regarding the method of video review? Is it fair to assume that all companies in the space receive the same guidance on that? Thank you.

Good morning, and thanks for taking our question. So maybe just another one on protocols here how much leeway do you think the agency provides regarding that.

The method of video review and is it fair to assume that all companies in the space received the same guidance on that thank you.

Sean Nolan: Yeah, Gil, I would say in our experience, the most time we spent in dialogue with the FDA was around the rigor of the data collection for the primary endpoint. They were very much focused on how we were gonna do that there was high fidelity in the data, and that there was high inter-rater reliability. In fact, what we did to further bolster our case with the FDA is we actually ran a pilot at multiple sites testing the DMA with multiple central raters. We submitted that as, you know, in part of our data package, you know, to get the protocol approved, also, you know, in the Breakthrough Therapy package as well.

Yes, Gil I would say in our experience.

So the most time, we spent in dialogue with the FDA was around the rigor of the data collection for the primary endpoint.

They were very much focused on how we were going to do that because there was high fidelity in the data and that there was high inter rater reliability.

And in fact, what we did to further bolster our case with the FDA as we actually ran a pilot.

At multiple sites testing, the DMA with multiple central raters and.

And we submitted that as in.

Part of our data package to get the protocol approved.

And also in the breakthrough therapy package as well.

Sean Nolan: You know, all I can say is that, like anything, you're as good, in our space, you're as good as the data that you're collecting. FDA was super focused on that. I'm assuming anyone going into a pivotal trial, you know, would be held to the standard of a minimum of video evidence and having it centrally adjudicated. I think the question is, you know, have you run the experiment, and do you know that the methodology you're employing is gonna give you the result that you anticipate? What we feel good about is we've run that result. You know, we've collected the data from, you know, our Part A study, and we've done, you know, central raters with that.

So all I can say is that.

Like anything here is good in our space you are as good as the data that you're collecting FCA was super focused on that so I'm, assuming any one going into a pivotal trial.

Would be held to the standard of a minimum of.

Leo evidence and having it centrally adjudicated I think the question is.

Have you run the experiment.

And do you know that the methodology or employing is going to give you. The result that you anticipate and what we feel good about is we've run that we've run that result.

We've collected the data from our part a study and we have done.

Central Raters with that but then the pilot study, which you really havent talked too much about but we ran that in the background again at multiple sites and that gives us the confidence and hopefully.

Sean Nolan: The pilot study, which we really haven't talked too much about, but we ran that in the background again at multiple sites, and that gives us the confidence and, hopefully, you know, gave the FDA confidence, that what we're putting forward is highly rigorous, high in fidelity, and, you know, high in inter-rater reliability.

The FDA confidence.

And what we're putting forward is highly rigorous high fidelity and.

Hi, and inter rater reliability.

Gil Blum: Thank you for all that.

Thank you for all that.

Sean Nolan: Thanks, Gil.

Thanks, Joe.

Operator: Our next question comes from Biren Amin with Piper Sandler. Your line is open.

Our next question comes from Byron Aman with Piper <unk> Piper Sandler Your line is open.

[Analyst] (Piper Sandler): Hey, good morning. Thank you for taking our questions. This is Michael on for Biren. Are there any updates on your plans in Europe or discussions with the EMA on the applicability of Part B? Separately, is the bar for the interim analysis similar to that for the final 12-month analysis? Thank you.

Hey, good morning. Thank you for taking our questions. This is Michael on for Purion are there any updates on your plans in Europe or discussions with the EMA on the applicability of part D and.

Separately as the bar for the interim analysis similar to that for the final 12 month analysis. Thank you.

Sean Nolan: Thanks, Michael. Thanks for the question. You know, first and foremost, you know, our focus has been and will be on the US number one, two, and three. I mean, that's the biggest market out there. You know, we've been historically resource constrained, both financially as well as human resource, capital wise. We're in a better position now, but we've really worked to make sure that we are as aligned as possible with the highest probability possible, you know, to get things approved as safely and as quickly as we can in the US. We will continue, what we've been doing, Michael, with Europe and the UK is working to enable them. You know, stepping through regulatory, you know, dialogues and things of that nature.

Yeah. Thanks, Michael Thanks for the question.

First and foremost.

Our focus has been and will be on the U S number one two and three I mean, that's that's the biggest market out there.

We've been historically resource constrained both financially as well as human resource capital Wise, we're in a better position now, but we've really worked to make sure that we are as aligned as possible with the highest probability possible to get things approved as safely and as quickly as we can.

In the U S.

We will continue and what we've been doing Michael with Europe.

In the UK is working to enable them so stepping through regulatory.

Okay.

Dialogues and things of that nature, we think that as we further generate data in part a.

Sean Nolan: We think that as we further generate data in Part A and also get into Part B, that will further inform those discussions and will give us even clearer line of sight to what the options we have. I mean, we know we're gonna have multiple options to go into Europe. You know, there are some that we've taken in the past that would be the most efficient and make the most sense for all parties involved. You know, we wanna see if we can work to enable that. The other thing too is, from a policy perspective, I think we all know the challenges on both sides of the pond. You know, we wanna make sure we focus here at home and lock in those things.

And also get into part B that will further inform those those discussions and will give us even clear line of sight to what the options. We have we know we're going to have multiple options to go into Europe.

Some that we've taken in the past that would be the most efficient and make the most sense for all parties involved we want to see if we can work to enable that.

The other thing too is from a policy perspective.

I think we all know the challenges on both sides of the pond.

Want to make sure we focus here at home and lock in those things and we can also take the time, where we're collecting the data to see how policy also shakes out from an ex U S perspective, as well so the long term goal is to enable Europe for sure.

Sean Nolan: We can also, you know, take the time while we're collecting the data to see how policy also shakes out from an ex-US perspective as well. The long-term goal is to enable Europe, for sure. It's just a question of stepping through it in a very thoughtful manner.

It's just a question of stepping through it in a very thoughtful.

Manner.

Operator: Our next question comes from Maury Raycroft with Jefferies. Your line is open.

Our next question comes from Maury Raycroft with Jefferies. Your line is open.

Maury Raycroft: Hi. Congrats on the progress, and thanks for taking my questions. Wondering if you'd tell us anything additional about timelines for IRB approvals for the additional two to five sites that you'll need for the pivotal. Just when thinking about enrollment for this study, is there anything more you could say about number of patients you could potentially have enrolled by end of this year? Just helping provide some line of sight to potentially getting to data from the pivotal by the end of next year.

Hi, Congrats on the progress and thanks for taking my questions.

I'm wondering if you could tell us.

Anything additional about timelines for IRB approvals for the additional $2 five sites that youll need for the pivotal.

And just when thinking about our enrollment for this study is there anything more you can say about number of patients you could potentially have enrolled by end of this year, just helping provide some some line of sight to potentially getting to data from from the <unk> pivotal by the end of next year.

Sean Nolan: Yeah, Maury, it's a great question. I think we can provide more information in either Q1 or, you know, sometime in the springtime, I think as we have better line of sight. Again, just from a how we're stepping through it, you know, we've submitted protocol to the FDA, have got a waiting for their feedback on that. You know, that'll certainly inform things. You know, we're doing I would say contextually, right, we're doing for the pivotal trial, 15 patients. This was a smaller subset of patients, so we would anticipate the number of patients to be less than 15 in this study.

Yes, it's a great question I think we can provide more information.

In either Q1 or sometime in the spring time, I think as we have better line of sight again just from a.

Power stepping through it we've submitted the protocol to the FDA <unk> got waiting for their feedback on that that will certainly inform things. We're doing I would say contextually right. We're doing for the pivotal trial 15 patients. This is a smaller subset of patients. So we would anticipate the number of patients to be.

Less than 15 in this study.

Sean Nolan: You know, I think that from a IRB perspective, it will be a new protocol, so it'll have to go through the process of, you know, contracting, IRB approval, ethics, you know, all the things that you have to do. I can tell you that there are, as you would anticipate, multiple sites, of course, that wanna be a part of this, so I don't think that's gonna be, you know, an issue. We just wanna make sure that, number 1, we get alignment, first and foremost, with the FDA on the protocol and the associated, you know, statistical plan that we're putting forward.

I think that.

From IRB perspective, it will be a new protocol. So it will have to go through the process of contracting IRB approval ethics all of the things that you that you have to do I can tell you that there are as you would anticipate multiple sites of course that want to.

Part of this so I don't think thats going to be.

An issue, we just want to make sure that number one we get alignment first and foremost with the FDA on the protocol and the associated.

Statistical plan that we're putting forward and then number two that from an operational perspective.

Sean Nolan: Number 2, that from an operational perspective, you know, we're doing things in a manner that is most efficient and doesn't by any way, you know, impede the enrollment of the 6-plus population. The way we see this, based on the fact that the primary endpoint in the little kids study is safety, you know, we think the 2 trains are gonna come back together. Again, just to make the point, that we do anticipate including that data along with the 6-plus pivotal data in the BLA submission with the goal of getting a broad label.

We're doing things in a manner that is most efficient and doesn't buy any way impede the enrollment of the <unk>.

<unk> population.

So the way we see this based on the fact that the primary endpoint in that.

The little Kid study.

Is safety.

We think the two trains are going to come back together and again just to make the point that we do anticipate including that data along with the six plus pivotal data in the BLA submission with the goal of getting a broad label.

Maury Raycroft: Got it. Okay, thanks for taking my questions.

Got it okay. Thanks for taking my questions.

Sean Nolan: Thanks, Maury.

Mark.

Operator: Our next question comes from Jack Allen with Baird. Your line is open.

Our next question comes from Jack Allen with Baird. Your line is open.

Jack Allen: Great. Thanks so much for taking the questions, and congrats on all the progress made over the course of the quarter. I guess my first one was on the broader sentiment of the FDA. There was quite a bit of news over the weekend and Monday morning surrounding CBER and some changes at CDER. I just wanted to get a sense for any thoughts that the team has as it relates to management interactions with the agency, whether the agency is functioning as expected, and what your plans are going forward to interact. Briefly on the, on the younger patient cohort, I also wanted to ask about how you're thinking about dose. As you go into younger patients, you could theoretically increase the relative exposure if you're treating smaller patients with a fixed dose.

Great. Thanks, so much for taking the questions and congrats on all the progress made over the course of the quarter I guess my first one was on the broader sentiment at the FDA there was quite a bit of news over the weekend and Monday morning, driving <unk> and some changes outside Cedar and I just wanted to get a sense for.

Any thoughts there the team has as it relates to management interactions with the agency whether the agency is functioning as expected and what your plans are going forward to interact and then briefly on that on the younger patient cohort I also wanted to ask about.

How youre thinking about dose.

As you go into younger patients you could theoretically increase the relative exposure youre trading smaller patients sort of fixed dose I'm. Just curious if you have any plans to address that potential issue.

Jack Allen: I'm just curious if you have any plans to address that potential issue.

Sean Nolan: Jack, let me start with the second part of your question on dose. It's gonna be 1E to the 15th, but we're gonna adjust for brain volume. We wanna make sure that none of those younger kids get any more dose on a per kilogram basis than anyone we've dosed so far safely. You know, we've given that a lot of thought. The clin dev team's done a super job. Again, we've got that in front of the FDA, so we're being very thoughtful about that safety perspective. More to come on that once we, you know, have the protocol finalized. You know, as it relates to the FDA, you know, what we can point to is a couple things.

Yes, Jack let me start with the second.

Part of your question on dose.

Going to be wanting to the 15th but we're going to adjust for bring volume. So we want to make sure that none of those younger kids get any more dose on a per kilogram basis than any one we've done so far safely. So we've given that a lot of thought.

The <unk> team has done a super job again, we've got that in front of the FDA. So we're being very thoughtful about that safety perspective, so more to come on that once we.

The protocol finalized.

As it relates to the to the FDA.

We can point to as a couple of things.

Sean Nolan: I said this earlier, we had good alignment with Nicole Verdun, right? I mean, nothing that we've changed, we've done nothing since the new regime's been in that's different in terms of our natural history assessment, our proposed endpoints, et cetera. I've used this term before, but no one has pushed us off the ball, and the reason we believe that is because we have levered data collected in a very rigorous manner to make our case with the FDA. Number 2, the approach that we're taking is exactly what the FDA wants, so that's why we reference this FDA guidance from September where they're basically saying, Hey, for gene and cell therapies, we want alignment on your protocol and your SAP before you start the study. What are we doing?

Said this earlier.

We had.

We had good alignment with Nicole for Dol.

Alright.

Nothing that we've changed that we've done nothing.

The new regime has been in that's different in terms of our natural history assessment, our proposed endpoints et cetera.

And I abuses.

Term before but no one has pushed us off the ball and the reason we believe that is because we have levered data collected in a very rigorous manner to make our case with the FDA.

Number two the approach that we're taking.

Exactly what the FDA wants so that's why we referenced this FDA guidance from September where they're basically, saying hey, we're seeing for gene and cell therapies, we want alignment on your protocol in your SAP before you start the study.

So what are we doing we've taken our first in human study.

Sean Nolan: We've taken our first in-human study, we've learned from that. We've done the natural history analysis. Now what we're saying is from based on what we learned, we're gonna propose a prospective pivotal trial with the following endpoint and the following statistical analysis plan, and we've worked with the FDA to get that into, you know, a situation where they've signed off on that. We've done exactly what they wanted. Our understanding is any of these milestone meetings, you know, like signing off on a protocol or, you know, Breakthrough designation, which I can talk about in a second, but internally the directors are in those meetings. You know, we've checked and double-checked to make sure we're not misinterpreting things. We've gotten confirmation of that. We feel like we've done everything that the FDA has asked us to do.

We've learned from that.

We've done the natural history analysis and now what we're saying is from based on what we learn and we're going to we're going to propose a prospective pivotal trial with the following endpoint and the following statistical analysis plan and we've worked with the FDA to get that into.

A situation, where they have signed off on that.

So we've done exactly what they wanted our understanding is any of these milestone meetings like signing off on a protocol or breakthrough designation, which I can talk about it in a second but internally.

The directors are in those meetings.

So.

We've checked and double check to make sure we're not misinterpreting things, we've gotten confirmation of that we feel like we've done everything to the FDA.

He has has asked us to do and more importantly, we're not asking them to do something that's out of course.

Sean Nolan: More importantly, we're not asking them to do something that's out of course. You know, what we're not doing is we're not taking the Part A data and saying, Oh, you know what, we want you guys to, you know, go back and we're gonna propose now that we're doing a DMA, and we're gonna do these developmental milestones, so we want you to approve our data based on, you know, a statistical plan we put in front of you after the fact. That is not something that we've done. We're taking a more traditional approach and starting a new study. Suku wants to add some information.

We're not doing is we're not taking this.

The part a data and saying Oh, you know what let's we're going to we want you guys to.

Go back and we're going to propose now that we're doing a DMA and we're going to do this developmental milestones. So we want you to approve our data based on.

Our statistical plan, we put in front of you. After the fact that it's not something that we've done we're taking a more traditional approach and starting a new study suite grew wants to add some information, yes, one thing I would add Sean is that Dr.

Sukumar Nagendran: One thing I would add, Sean, is that under Dr. Vinay Prasad and Vijay Kumar's current leadership of CBER, their team has followed the spirit of the RMAT designation in CBER and the breakthrough designation that we have achieved, our interactions have been very fluid and very constructive and very useful. I just wanted to emphasize that, Sean.

Dr <unk> and <unk> the current leadership of CEVA.

Team has followed the spirit of the Almac designation and Ciba and the breakthrough designation that we have achieved so our interactions have been very fluid and very constructive and very useful. So I just wanted to emphasize section yes, Jack one last thing on breakthrough to the <unk>, making.

Sean Nolan: I mean, Jack, one last thing on Breakthrough to the point Suku's making. The internal SOP at FDA for Breakthrough is that when a Breakthrough request comes in, the directors are made aware of it. They then send it to the review team and assign them to review it and let them know the recommendation. That means that eyes are on things. Again, we've done the best that we can to be data-driven in all of our requests, and therefore, again, we feel the fact that the Breakthrough was granted, you know, in September under this current regime in the manner that they like, we followed their guidance that they've issued in September in terms of protocol for pivotals as well as SAP.

The internal SLP.

EBITDA for breakthrough is that when a breakthrough request comes in the directors are made aware of it.

They then send it to the review team and assigned them to review it and let them know the recommendation.

And so.

That means that either on things.

And again, we've done the best that we can to be data driven and all of our requests and therefore again, we feel the fact that the breakthrough was granted.

In September under this current regime in the manner that they like we followed their guidance that they issued in September in terms of protocol for pivotal as well as us.

Sean Nolan: You know, we've tried to step through it, you know, in exact manner that they want, and I would argue the exact manner based on data that any administration would want. You know, that's why I kinda went back into the way back machine with the Peter Marks group, but it is important, and I do think it's relevant to say they agreed with what we were doing as well based on the way that we were going through it. I've always said data drives, you know, is the currency of the realm, and we believe that's the case. We're just gonna keep moving forward and be as transparent as we can with the agency.

We're.

We've tried to sell through at an exact manner that they want and I would argue the exact manner based on data that any administration would want so that's why I kind of went back into the way back machine with Peter marks group, but it is important that I do think it's relevant to say they agreed with what we were doing as well.

Based on the way that we were going through it. So I've always said data that drives the currency of the realm and we believe that's the case, we're just going to keep moving forward and be as transparent as we can with the agency and as a result of having breakthrough.

Sean Nolan: As a result of having breakthrough, you know, we now can set up even additional meetings with them, which we've already done, you know, to start to talk about BLA submission process and things of that nature.

We now can set up even additional meetings with them, which we've already done.

To start to talk about BLA submission process and things of that nature.

Jack Allen: Thank you so much. That's great color.

Thank you so much that's great color.

Sean Nolan: Thanks, Jack.

Thanks Jack.

Operator: Our next question comes from Chris Raymond with Raymond James. Your line is open.

Our next question comes from Chris Raymond with Raymond James Your line is open.

Chris Raymond: Hey, thanks. Just a couple of commercial questions here maybe. You're starting the commercial build-out now with the hiring of a chief commercial officer. Maybe talk about the footprint you'll need, how it will look, and maybe the milestones that we should expect, you know, in terms of, I guess, you know, access, progress. Maybe a related question, you know, of the 28 developmental milestones, are there any that you think matter more, you know, be it communication, fine motor, or gross motor milestones in terms of clinical acceptance among the physician community or in terms of ease of access that we should be thinking about? Thanks.

Hey, Thanks, just a.

A couple of commercial questions here, maybe so youre, starting the commercial build out now.

With the hiring of a chief commercial officer, maybe talk about the footprint you'll need.

How it will look and maybe the milestones that we should expect in terms of.

Yes.

Access.

Progress and then maybe a related question.

Of the 28 developmental milestones are there any that you think matter more b communication fine motor gross motor milestones in terms of clinical acceptance among the physician community or in terms of ease of access that we should be thinking about.

Thanks.

Sean Nolan: Yeah. I think to start with your second question, all of the 28 milestones that we've selected we did in concert with KOLs and with the advocacy community. Like, if you were talking to some of the KOLs, they would talk about higher order milestones. There's 51 milestones, Chris, in the natural history database. You'll hear like that language because these are the milestones that, you know, from a clinical and from a functional perspective really do matter across the three different domains. You know, I wouldn't say, you know, any one rises to the level more than anyone else. It's all relevant to the particular situation of each individual patient. I will say that when you talk to the parents, you know, communication is top of mind with them.

Yes, I think to start with your second question all of the 28 milestones that we've selected we did in concert with Kols and with the.

Advocacy community. So like if you were talking to some of the Kols They would talk about higher order.

Milestones, so theres 51 milestones Chris in the natural history database.

Youll hear like that language because these are the milestones that from a clinical and from a functional perspective really do matter across the three different domains.

So I wouldn't say any one rises to the level more than anyone else thats all relevant to the particular situation of each individual patient.

I will say that when you talk to the parents.

Communication is top of mind with them they want to know what hurts what do they want are they hungry.

Sean Nolan: You know, they wanna know, you know, what hurts, what do they want, are they hungry, you know, how can they make them feel better, you know, those kinds of things which make a lot of sense. That's why, you know, we feel we've reached that agreement with the FDA that any one of those 28 is relevant. I think what we're also trying to show is that, you know, over time, not only are there more milestones being gained of the 28, but the whole purpose of the supplemental analysis was to show that outside of that, I mean, the 28 are a mechanism for us to get approval. Outside of that, in multiple scales, whether it be done from the clinicians or rated independently like the Mullen or the ORCA, which is the parents, what they're saying that they're noticing.

How can they make them feel better those kinds of things, which make a lot of sense, but thats why we feel we've reached that agreement with the FDA that any one of those 28 is relevant and I think what we're also trying to show is that over time not only are there more milestones being gained at the 28.

The whole purpose of the supplemental analysis was to show that outside of that I mean, the 28 or a mechanism for us to get approval, but outside of that in multiple scales, whether it would be done from the clinicians or rated independently like the mullen or.

The Orca, which is the parents with what they're saying that they are noticing.

Sean Nolan: You know, the point of that was to say beyond the 28 that we've talked about, there's a lot of other things happening that are great. We're seeing good things. The parents are seeing things. The clinicians are seeing improvements in function. You know, and all of that is gonna be, you know, what we put forward to the FDA in the final package and would also be part of what we discuss with payers.

The point of that was to say beyond the 28 that we've talked about there's a lot of other things happening that are great and we're seeing good things. The parents are seeing things the clinicians are seeing improvements in function.

And all of that is going to be what we put forward to the FDA and the final package and would also be part of what we discussed with Payors.

Sukumar Nagendran: Yeah, yeah, thanks, Sean. One more thing I would add is that, Chris, as our trial design is patient as their own control, every milestone matters. It doesn't matter what the milestone is out of the 28 to the patient, to the parent or the caregiver. All of them actually matter, and all of them have impact on activities of daily living. Given our Part A data set, my hope as a physician and clinician is that there will be no patient left behind over time as we gather more data from Part B.

Yeah, Thanks, Sean and one more thing I would add is that.

Chris.

Our cloud designed as patient as their own control every milestone method. So it doesn't matter what the milestone is out of the 28 to the passion to the payment of the caveat all of the mentioned and I think all of them have impact on activities of daily living and given our partner dataset and my hope is a physician and clinician is that that will be.

No patient behind over time, as we gather more data from part B.

Sean Nolan: Yeah. The first part of your question, Chris, about commercial, you know, I'd say a couple things. First, you know, you're definitely on the leading edge of the curve here. You know, we think starting in Q1, you know, we really are going to put more color around how we see the commercial opportunity. I think for starters, it really is underappreciated how large the patient population is. We're doing a lot of work, you know, relative to claims data analysis and things of that nature to put finer points on things. We're also looking at the launch of DAYBUE. I mean, that's gonna be a good surrogate for potential uptake.

And then the first part of your question Chris about commercial.

I'd say a couple of things first.

You are definitely on the leading edge of the curve here, we think starting in the first quarter, we really are going to put more color around how we see the commercial opportunity I think for starters. It really is underappreciated how large the patient population is so.

We're doing a lot of work relative to claims data analysis and things of that nature to put finer points on things. We're also looking at the launch of debut I mean, thats going to be a good surrogate for potential uptake and the more that we're digging into things.

Sean Nolan: The more that we're digging into things, you know, the more robust we think the opportunity truly is, particularly in a situation where, you know, the data set that we're gonna be able to discuss with payers and also get the treating clinicians and the families, you know, hopefully excited about what they're seeing is that, you know, no one's been able to demonstrate functional gains before in a neurodevelopmental disease, even in adults. That opens up a really significant opportunity. You know, we also have known from the get-go that using CGI and RSBQ and those type of scales is gonna mean absolutely nothing to the payers. They do not care what you know, a CGI score actually is.

More robust we think the opportunity truly is particularly in a situation where the data set that we're going to be able to discuss with payers and also get the treating clinicians and the families. Hopefully excited about what they're seeing is that no one's been able to demonstrate functional gains before and a neurodevelopmental diseases.

Even though in adults so that opens up a really significant opportunity.

We also have known from the get go that using CGI and <unk> and those type of skills is going to mean, absolutely nothing to the pairs they do not care what.

CGI score actually is they want to know what they are paying for and what they're going to be paying for is going to be improvements in function or gains a function that havent been demonstrated which is why we feel so strongly that this endpoint for a gene therapy is the right way to go.

Sean Nolan: They wanna know what they're paying for, what they're gonna be paying for is going to be improvements in function or gains of function that haven't been demonstrated, which is why we feel so strongly that this endpoint for a gene therapy is the right way to go. You know, an example is in Canada, the HTA denied DAYBUE being reimbursed because they couldn't determine the clinical relevance of a 0.3 change in CGI. Again, I think we're gonna be on really strong ground with the data set that we're putting forward in a very significant patient population. The other thing I'll say, just in terms of the team, you know, David McNinch is our new Chief Commercial Officer. He's got a ton of experience.

An example is in Canada, the HCA denied debut being reimbursed because they couldnt determine the clinical relevance of a 0.3 change in CGI. So again I think we're going to be on really strong ground with the dataset that we're putting forward in a very significant patient population.

And the other thing I'll say just in terms of the team.

David Mcninch as our new Chief commercial officer. He has got a ton of experience he and I worked together at Intermune.

Sean Nolan: He and I worked together at InterMune, you know, on the launch of Esbriet, which was a big success. David was also recently at Encoded. He knows gene therapy very well. He reports to Sean McAuliffe, who's our chief business officer. Sean was on the Zolgensma launch team. you know, we've got, you know, a very stacked group internally. I would say on a medical affairs team, you know, our head of medical affairs, Alon, you know, ran med affairs in Canada for Acadia. Like we feel like the field team and the commercial team, call it the external facing group, we've got a just a stellar all-star team, and we'll continue to put out, you know, more perspective on that as we generate the data and move towards the BLA submission.

On the launch of <unk>, which was which was a big success.

David was also recently at encoded gene therapy very well.

He reports to Sean Mccullough, Who's our Chief business Officer, Sean.

Was was on this whole Johnson the launch team. So we've got a very stacked group internally and I would say on the medical affairs team.

Our head of medical Affairs along.

<unk> met affairs in Canada for Acadia, So look we feel like the field team and the commercial team called the external facing group. We've got just a stellar all star team and we will continue to put out more perspective on that as we generate the data and and move towards the BLA submission great <unk>.

Sean Nolan: Great question.

<unk>.

Chris Raymond: Excellent. Thanks.

Excellent. Thanks.

Operator: Our next question comes from Yanan Zhu with Wells Fargo Securities. Your line is open.

Our next question comes from Yolanda Hu with Wells Fargo Securities. Your line is open.

Yanan Zhu: Oh, great. Thanks for taking our questions. Wanted to dig into the statistical plan a little bit. Thanks for all the color so far on the call regarding alignment and the FDA. Given that the trial design is novel and there is not a external control arm per se, wonder how the P value is derived. Also, in terms of the interim analysis, how unambiguous or subjective the threshold is for triggering filing based on interim. In other words, do you run any risk if you file on interim? Just wondering with regard to the actual data and the P value in making that decision. Thank you.

Oh, great. Thanks for taking our questions I.

I wanted to dig into the statistical.

A little bit thanks for all the Connersville Hong Kong.

<unk> alignment and the FDA.

Given that the trial design is overall and there is not a external control arm per se.

Wonder how.

The P value is derived and also.

Terms of the interim analysis.

How.

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Our subjective.

Threshold.

Is for triggering.

And based on interim.

In other words do you run any risk.

If you file an insurance just wondering with regard.

The actual data on the P value in making that decision. Thank you.

Sukumar Nagendran: That's a good question, Yanan. I'll try to answer that for you in, in kind of very simple, straightforward terms. The evaluations are not subjective. They're actually quite objective, because remember, we have a natural history that is very tightly analyzed, and the FDA accepted our natural history analysis, but it's very clear on this, once these patients get above 6 years of age, they do not gain new milestones or they do not regain milestones. Our e-evaluation process for achievement of new milestones or regain of milestones is video recorded, and as Sean has pointed out earlier, it's very rigorously evaluated by blinded central reviewers. There are different reviewers for the 6-month interim analysis as well as the 12-month interim analysis, you have to keep that in mind as well.

So that's a good question so I'll try to answer that for you and kind of very simple straightforward terms. So.

The evaluations are not objected actually quite objective because remember we have a natural history that is very tightly analyzed and the FDA accepted our natural history analysis, that's very clear one of these once these patients get above six years of age do not gain new milestones that they do not regain milestones.

Elevation process for achievement of modern new milestones a regain of milestones as video recorder, then as Sean has pointed out earlier, it's very rigorously evaluated by blinded Central review is and Thats different reviews for the six month interim analysis as well as a 12 month interim analysis. So you have to keep that in mind as well now remember also the six months.

Sukumar Nagendran: Remember also the 6-month interim analysis, all 15 patients dosed have to reach that 6-month time point before we break the blind on the video evaluations and before we share the information of the data with the FDA for potentially filing on the BLA as we complete the study at 12 months, and that data set will also be available at the final filing of the BLA. What we do is, by the 6-month interim analysis process, we have the opportunity to shorten the timeline of filing of the BLA by 2 quarters or more. Again, the 6-month interim analysis also does not really have significant impact on the P value nor the power of the study given that the loss of the alpha is actually minimal.

Analysis, all 15 patients dosed have reached a six month time point before we break the blind on the video evaluations and before we share the information on the data with the FDA for potential filing of the BLA as we complete the study at 12 months and that data set will also be available at the final filing of the BLA.

We do it by the six month interim analysis process, we have the opportunity to shorten the timeline of filing of the BLA by two quarters or more so again.

The six month interim analysis also does not really cause have significant impact on the P value. The power of the study given that the loss of the outsized actually many months and its a 33% responder rate.

Sukumar Nagendran: It's a 33% responder rate is all that's needed really to meet our primary endpoint, whether it's a 6-month or 12-month analysis. Keep in mind that usually none of these patients at 6 months reach a new milestone or regain a lost milestone. Therefore, any milestone gain won by 1 patient is miraculous. I believe it at that from a clinician's perspective. I think we have something that we I hope that we can gather the data quickly and get our data set to the FDA so that we can make this therapy available to patients as soon as possible. I hope that answers your question, Yanan.

Thats needed agility to meet our primary endpoint with a six month or 12 month analysis and keep in mind that usually none of these patients at six months reached a new milestone of three <unk>.

In our last milestone therefore, any milestone gained one by one patient is Matthew so I'll leave it at that from a physician's perspective.

We have some things that I hope that we can gather the data quickly and get our datasets to the FDA. So that we can make this therapy available to patients as soon as possible.

I hope that answers your question or not.

Yanan Zhu: Yeah. Yes, great. Thanks for the comment.

Yeah, great. Thanks for color.

Okay.

Operator: Our next question comes from Joon Lee with Truist Securities. Your line is open.

Our next question comes from Joon Lee with <unk> Securities. Your line is open.

Mehdi Goudarzi: Hi, good morning. This is Mehdi Goudarzi for Joon Lee, and thanks for taking our question. The question is I just wanted to ask you to please remind us what is the actual definition of regaining again? Assuming that, you know, at the six month interim data is positive, how soon you can start filing for BLA? Thank you.

Hi, Good morning, this is Matt <unk>.

June and thanks for taking our question.

So.

The question is I just wanted to.

Ask you to please.

Remind us what is the actual definition of regaining.

Ken.

And assuming that.

At the six months.

Between there is positive how.

Sue Knutson start filing appropriately.

Okay.

Sukumar Nagendran: Yeah. Thanks for that question. This is Suku, and I'll respond to that question because it's thanks, because it's important that it's clearly defined and the audience understands what it means. Remember again, natural history, once patients with Rett syndrome reach the age of six and above, they do not regain a lost milestone. I'll give you an obvious one. Let's assume a patient before six years of age with Rett syndrome can sit up without support, and they lose it completely and now cannot sit up without support. Post-treatment with TSHA-102 or gene therapy through lumbar puncture, if that patient now again is able to sit without support, that is a regain of a lost milestone.

Yes. Thanks for that question. So this is <unk> and I'll respond.

To ask a question because it's a tax because it's important that scale as defined in the audience understands what it means.

So remember again natural history once patients with Ret syndrome reached the age of six and above there do not regain lost milestone. So I'll give you an obvious one let's assume a patient before six years of age with the ret syndrome setup without support and they lose it completely and now cannot sit up without support post treatment with <unk> or not.

Our gene therapy through lumbar puncture.

Now again as able to sit without support that is a regain of our last milestone.

Sukumar Nagendran: A gain of a new milestone is something where the patient before the age of 6, for example, can never use their fingers due to significant stereotypic movements and therefore cannot pick up a teaspoon or a cup to feed themselves. Post-treatment, this milestone is now achieved where the patient can actually use their fingers, which they're never done before, can pick up a spoon or a cup and feed themselves. That is the gain of a new milestone. It's very almost black and white. Which is actually makes it very easy both for the clinicians who are evaluating the patients, the video reviewers who are blinded, as well as when the FDA hopefully sees our videos, it'll make it obvious that our product actually works.

Again off a new milestone is something where the patient before the age of six example can never used the athene, thus due to significant stereotactic movements and therefore cannot pick up a teaspoon workup to feed themselves post treatment. This milestone has now achieved where the patient can actually use their fingers. We said never done before can pick up a spoon on.

Cup and feed themselves that is again off a new milestone sits very almost black and white, so which is actually makes it very easy for the clinicians are evaluated the patients. The video reviewers who are blinded as well as when the FDA hopefully see BT.

And also it will make it obvious that our product actually works and keep in mind that this entire process of video recording central Raters, blinding et cetera came from our <unk> experience many years ago and we have most of the team here at Asia that will continue to execute on this program and hopefully pretty swiftly pivoted off of SMA population using a <unk>.

Sukumar Nagendran: Keep in mind that this entire process of video recording, central raters, blinding, et cetera, came from our AveXis experience many years ago, and we have most of the team here at Taysha that will continue to execute on this program and hopefully reproduce what we were able to do for our SMA population using AVXS-101, which is now Zolgensma. Thank you.

101000, Jane Smith, Thank you.

Operator: It appears we have no further questions at this time. I'll turn the program back to the speakers for any additional or closing remarks.

It appears we have no further questions at this time I'll turn the program back to the speakers for any additional or closing remarks.

Sean Nolan: We appreciate everyone taking the time this morning to join us. Have a good day. Thank you.

We appreciate everyone taking the time this morning to join US have a good day. Thank you.

Operator: This concludes today's program. Thank you for your participation, and you may disconnect at any time.

This concludes today's program. Thank you for your participation and you may disconnect at any time.

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