Taysha Gene Therapies, Inc.

Greetings and welcome to the Tayshia Gene Therapy's fourth quarter and full year 2022 earnings call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Haley Collins, Director and Head of Corporate Communications. Thank you, Ms. Collins. You may begin.

Thank you. Good afternoon and welcome to Tayshia's fourth quarter and full year 2022 Financial Results and Corporate Update Conference Call. I'm Haley Collins, Tayshia's recently appointed Director and Head of Corporate Communications. I will also be overseeing investor relations activities. I bring corporate communications experience in rare diseases, having previously served in a similar role at Jaguar Gene Therapy. I'm excited to join Tayshia at this pivotal time and look forward to working with the team to help bring potentially life-changing therapies to patients with rare diseases with high unmet medical needs. Earlier today, Tayshia issued a press release announcing financial results for the fourth quarter full year 2022. A copy of this press release website and through our SEC filings. Joining me on today's call are Sean Nolan, Taysha's CEO, Sukumar Nagendran, President and Head of R&D, and Cameron Alam, Chief Financial Officer. 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 Taysha 120 and and the therapeutic and commercial potential of Tayshia 120 and Tayshia 102. These statements may include expected timing and results of clinical trials of 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 Tayshia'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 TASHA'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 the risks and uncertainties that we face, please see the reports that we have filed with the Security and Exchange Commission, including our annual report on Form 10-K for the year ended December 31, 2022. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, March 28, 2023. Patients undertake 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 security 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 2022 fourth quarter and full year financial results and corporate update conference call. Today, I will begin providing a brief corporate outlook for 2023. Then, Sukhu Nagendra, President and Head of R&D of Kaysha, will provide an update on our clinical development programs, followed by a financial update from Cameron Alam, our Chief Financial Officer. I will then provide closing remarks before opening the call-up for questions. The actions taken earlier this year to improve execution and expedite progress with our two lead clinical programs in Rett Syndrome and GAN are having a positive effect. For TASIA-102 and Rett Syndrome, we remain on track to execute across our timelines for both initial available safety data and regulatory submissions this year in our ongoing Phase 1-2 Reveal Adult Study. Suku will provide further details here shortly. Fertatia 120 in GAN, an ultra-rare disease with no currently approved treatments. We recently received constructive feedback from the FDA regarding our follow-up questions to the Type B end of Phase II meeting. We are completing a comprehensive review of the data from the ongoing natural history and interventional trial, including functional, biological, and electrophysiological assessments. The preliminary analysis appears encouraging, and we believe there are some compelling new findings that we intend to share with the FDA to further discuss a potential regulatory path forward. Again, Sukhu will discuss this in further detail shortly. In the year ahead, we remain focused on achieving the anticipated near-term milestones in 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 Rett syndrome and GAN programs. Sukhu?