Taysha Gene Therapies, Inc.

Thank you for standing by. Welcome to Tayshia Gene Therapy's third quarter 2022 financial results and corporate update conference call. At this time, all participants are in listen-only mode. Following management's prepared marks, we will hold a brief question and answer session. As a reminder, this call is being recorded today, November 8, 2022. I will now turn the call over to Dr. Kimberly Lee, Chief Corporate Affairs Officer. Please go ahead.

Good morning and welcome to Tayshia's Third 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. Suresh Prasad, Chief Medical Officer and Head of R&D, and Cameron Alon, Chief Financial Officer. After our formal remarks, we will conduct a question and answer session and instructions will follow at that time. Earlier today, Tayshia issued a press release announcing financial results for the third quarter ended September 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, as well as the strategic investment by Estellas. These statements may include the expected timing and results of clinical trials for our product candidates, our expectations regarding the data necessary to support regulatory approval of TASHA 120 and the regulatory status and market opportunity for TASHA 120, TASHA 102, and TASHA's other clinical programs, as well as the potential benefits of the strategic investment by Astellas, including the potential for Astellas to exercise any of the options we granted to them. This call may also contain forward-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 surgeries 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 that 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, November 8, 2022. 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 law. I would now like to turn the call over to our President, Founder, and CEO, R.A. Session II. R.A.?

Thank you, Kim. Good morning and welcome, everyone, to our 2022 Third Quarter Financial Results and Corporate Update Conference Call. I am very proud of what the company has accomplished in the past few months. The strategic investment from Astellas and the successfully completed public follow-on offering have strengthened our balance sheet and extended our cash runway into the first quarter of 2024. We are excited about the recent strategic investment from Astellas to support the development of TASHA 120 for gynexonal neuropathy, or GAN, and TASHA 102 for Rett syndrome. The partnership with Astellas underscores the therapeutic and market opportunity of these two programs, and importantly, further validates our scientific approach of combining established gene therapy technology with innovative targeted payload design. Under the terms of the agreement, Estellas will make a $50 million investment in Tayshia in exchange for 15% of Tayshia's outstanding shares pre-follow-on financing, as well as an exclusive option to license the worldwide development, manufacturing, and commercial rights to Tayshia 120 in GAN For a period of time after receipt of the formal Type B into Phase II meeting minutes from the FDA, a cellist will also receive an exclusive option to license the Worldwide Development, Manufacturing, and Commercial Rights to TASHA-102 in Rett Syndrome for a period of time after we provide a cellist access to certain clinical data from the planned Rett female pediatric studies. Estellas will also receive a right of first offer related to a change in control of Tayshia for a period of time after receipt of the REC clinical data package. To further strategically align the two companies, Estellas will also receive one board observer seat on the Tayshia Board of Directors, enabling us to leverage Estellas' clinical and commercial expertise. The economics associated with the potential licenses will be negotiated by both companies At a later date, should Astellas decide to exercise any of its options. Next slide. We believe we have selected the best possible partner in Astellas, a premier biopharmaceutical company that has built global R&D, manufacturing, and commercialization capabilities. Astellas is a dedicated leader in the field of gene therapy with large-scale, fully integrated, in-house GMP manufacturing. Building upon Astellas' acquisition of Audentes, This partnership fits strategically within their long-term vision of expanding its gene therapy capabilities and enhancing focus on genetic regulation to ultimately bring new transformative gene therapies for serious genetic diseases with limited treatment options. We believe Estella's clinical development and commercialization experience, combined with Tayshia's capabilities and know-how in gene therapy, will help us achieve our shared objectives, We look forward to this partnership and the potential to bring life-changing treatments to patients around the world. In 2023, we expect to provide an update on the regulatory pathway for TASHA 120 in GAN in January, following our Type B into Phase II meeting with the FDA. In addition, we intend to disclose preliminary clinical data for TASHA 102 from the first cohort of adult patients with Rett syndrome and initiate a Phase 1-2 clinical study for TASHA-102 in female pediatric patients with Rett syndrome in the first half of 2023. I will now turn the call over to Suyesh to discuss our clinical programs. Suyesh?