Taysha Gene Therapies, Inc.

Thank you for standing by. This is the conference operator. Welcome to the Tayshia Gene Therapy's first quarter 2023 earnings conference call. As a reminder, all participants are in listen-only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. To join the question queue, you may press star then one on your telephone keypad. Should you need assistance during the conference call, you may signal an operator by pressing star and zero. I would now like to turn the conference over to Haley Collins, Director, Head of Corporate Communications. Please go ahead.

Thank you. Good afternoon and welcome to Tayshia's first quarter 2023 Financial Results and Corporate Update Conference Call. Earlier today, Tayshia issued a press release announcing financial results for the first quarter 2023. 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, Tayshia's CEO, Sukumar Nagandran, President and Head of Research and Development, Cameron Alam, Chief Financial Officer, and Salman Bhai, Assistant Professor of Neurology at UT Southwestern. We will hold a question and answer session following our prepared remarks. Please note that on today's call, we will be making forward-looking statements including statements relating to the existing clinical data for TASHA 120, the therapeutic and commercial potential of TASHA 120 and TASHA 102. These statements may include expected timing and results of clinical trials for our product candidates and other clinical and regulatory plans and the market opportunity for those programs. This call may also contain forward-looking statements relating to TASHA'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 Tayshia's actual results to differ materially from those stated or implied in such forward-looking statements. These risks include uncertainties related to the timing and results of clinical trials of and regulatory interactions for our product candidates, our dependence upon strategic alliances and other third-party relationships, our ability to obtain patent protection for our discoveries, limitations imposed by patents owned or controlled by third parties, and the requirements of substantial funding to conduct our research and development activities. For a list and description of these risks and uncertainties that we face, please see the reports we have filed with the Security and Exchange Commission, including our annual report on Form 10-K for the year ended December 31st, 2022. The conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 11th, 2023. 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. With that, I would now like to turn the call over to our CEO, Sean Nolan.

Thank you, Haley, and welcome, everyone, to our 2023 First Quarter Financial Results and Corporate Update Conference Call. Today, I will begin with a brief corporate update. Then Dr. Sukhu Nagendran, President and Head of R&D of Tayshia, will provide an update on our clinical development programs, along with our collaborator, Dr. Salman Bai, Assistant Professor of Neurology at UT Southwestern. Cameron Alam, our Chief Financial Officer, will then follow up with a financial update before I provide closing remarks and open the call up for questions. We've made significant progress across two lead programs, in Rett syndrome and giant axonal neuropathy this year and remain on track to deliver on multiple key milestones, including the generation of first-in-human clinical data for TASHA 102 in adult patients with Rett syndrome, the submission of a CTA to the MHRA to initiate expansion of TASHA 102 in pediatric patients, the submission of an IND application to the FDA for TASHA 102, and obtaining further clarity from the FDA on the regulatory path forward for TASHA 120 in GAN. Screening is completed and the dosing of our first potential patient with TASHA 102 in the Phase 1-2 Reveal Trial in adult Rett syndrome is scheduled for the second quarter of this year. For our GAN program, the new comprehensive analyses of the totality of the data for TASHA 120 continues to be encouraging and includes compelling findings that offer potential to further support a regulatory path forward. I want to highlight that much of the data presentation plan for the FDA will be new to the agency, and we will work to contextualize the data in a manner that clearly elucidates the potential for meaningful benefit to patients. We plan to submit the meeting request this quarter and expect the formal meeting to occur in the third quarter of this year. In the near term, we look forward to hosting an R&D day in June, where we will provide an overview of the GAN disease state and share these new clinical data analyses. Additionally, we plan to provide an update on our RET program. Sukku and Solomon will discuss this in more detail shortly. At the upcoming ASGTC conference, new preclinical data supporting TASHA-102 and the MI Rare technology in Rett syndrome will be presented as part of a poster presentation. We remain focused on achieving the anticipated near-term milestones for our Rett syndrome and GAN programs and continue to work towards our mission of bringing transformational new treatments to patients with these devastating neurodegenerative diseases. I will now turn the call over to Sukhu to provide a more in-depth discussion of our clinical programs in Rett Syndrome and GAN.