Taysha Gene Therapies, Inc.

Greetings. Welcome to the Tayshia Jean Therapy's second quarter 2022 financial results and corporate update conference call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a brief question and answer session. As a reminder, this call is being recorded today, August 11, 2022. I'll now turn the call over to Dr. Kimberly Lee, Chief Corporate Affairs Officer. Please go ahead.

Good morning and welcome to Tayshia's second quarter 2022 financial results and corporate update conference call. Joining me on today's call are Ari Session II, Tayshia's president, founder, and CEO, Dr. Fred Porter, chief technical officer, Dr. Suresh Prasad, chief medical officer and head of R&D, and Cameron Alam, chief financial officer. After our formal remarks, we will conduct a question and answer session and instructions will follow at that time. The lawyer today issued a press release announcing financial results for the second quarter ended June 30, 2022. A copy of this press release is available on the company's website and through our SEC filings. Please note that on today's call, we will be making forward-looking statements, including statements relating to the safety and efficacy and the therapeutic and commercial potential of our investigational product candidates. These statements may include the expected timing and results of clinical trials for our product candidates, are expectations regarding the data necessary to support regulatory approval of TASHA 120 and a regulatory status and market opportunity for those programs, as well as TASHA's manufacturing plans. This call may also contain foreign-looking statements relating to TASHA's growth and future operating results, discovery and development of product candidates, strategic alliances and intellectual property, as well as matters that are not of historical facts or information. Various risks may cause patients' 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 and preclinical studies of 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 we have filed with the Securities and Exchange Commission. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 11, 2022. TASIA 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 law. I would now like to turn the call over to our president, founder, and CEO, Ari Session II. Ari?

Thank you, Kim. Good morning and welcome, everyone, to our 2022 second quarter financial results and corporate update conference call. We continue to execute on the advancement of our core clinical programs and are excited to announce important data from our gynecological neuropathy, organ program, and Rett syndrome programs These data include stabilization and recovery of sensory nerve conduction in patients with GAN following treatment with TASIA-120, despite expectations of a rapid and irreversible decline in sensory function in untreated patients observed in natural history. Importantly, the measure of sensory nerve conduction represent a definitive clinical endpoint. In addition, we now have positive analytical comparability data demonstrating that our commercial grade and clinical trial material are functionally indistinguishable across all key quality attributes. Fred Porter, our Chief Technical Officer, will provide more details shortly. On the regulatory front, we had positive discussions with the UK's Medicine and Healthcare Products Regulatory Agency, or MHRA, and received feedback that we believe support our regulatory strategy. With full comparability data, in hand in conjunction with additional clinical data plus feedback from the MHRA, we believe this provides the most robust package to support our ongoing regulatory engagement. We expect to provide additional regulatory feedback, including from the FDA, by the end of this year. For Rett Syndrome, we are highly encouraged by late-breaking neonatal data in preclinical mouse models, demonstrating near normalization of survival and normalization of behavior. As you will hear from Suya shortly, we believe the totality of preclinical data generated to date by TASHA 102 is a comprehensive data set in Rett syndrome that further supports earlier treatment and clinical advancement of this promising product candidate. We look forward to reporting preliminary phase one slash two clinical data in adult females with Rett syndrome by the end of this year. Now we'll turn the call over to Fred to discuss updates on our comparability data for TASHA 120 and GAN. Fred?