Applied Genetic Technologies Corporation (NASDAQ:AGTC) Q1 2020 Earnings Conference Call - Final Transcript

Nov 12, 2019 • 04:30 pm ET


Applied Genetic Technologies Corporation (NASDAQ:AGTC) Q1 2020 Earnings Conference Call - Final Transcript


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Good afternoon and welcome to the AGTC First Quarter Fiscal Year 2020 Financial Results Conference Call. Today's call is being recorded.

Before we get started I'd like to remind everyone that during this conference call, AGTC may make forward-looking statements, including statements about the company's financial results, financial guidance, its future business strategies and operations and its product development and regulatory progress. Actual results could differ materially from those discussed in these forward-looking statements due to a number of important factors, including uncertainty inherent in the clinical development and regulatory process and other risks described in the Risk Factors section of AGTC's Annual Report on Form 10-K for the fiscal year ended June 30th, 2019.

For introductions and opening remarks, I'd like to turn the call over to Sue Washer, Chief Executive Officer of AGTC. Please go ahead.

Sue Washer

Good afternoon, and thank you all for joining us today. With me on today's call is Bill Sullivan, our Chief Financial Officer; Mark Shearman, our Chief Scientific Officer; and Theresa Heah, our Chief Medical Officer.

The first quarter of fiscal year 2020 was a significant one for AGTC and the patients we seek to serve. In September, we reported top line six-month XLRP dose escalation data as well as preliminary three-month data from the XLRP dose expansion cohort, showing stability of visual function in the periphery and improvement of visual function centrally. We also provided an early look at data indicating biological activity in both of our achromatopsia trial. While Theresa will provide a brief recap of these data shortly, the bottom line is that data from all three trials are compelling. For XLRP, we plan to continue our interaction with the FDA with the goal of initiating a pivotal trial in the second half of 2020.

We are excited to announce that we'll host an R&D Day on January 28th, 2020 in New York City. This will be an opportunity for you to get an in-depth review of our clinical programs, interact with clinicians, surgeons and patients and also thoroughly analyze all the clinical data available by that date and our plans to move forward. We hope to see all of you there and we'll provide more detail as the time approaches.

We also expanded our preclinical pipeline, both through the advancement of multiple internal programs and with the establishment of a strategic collaboration with the San Diego-based otology focused company, Otonomy, to develop an AAV-based gene therapy for congenital hearing loss.

Additionally, last week we disclosed that Stargardt disease, an inherited form of macular degeneration that most often results from mutations in the ABCA4 gene, is our second internal preclinical ophthalmology program, along with dry MD. Mark will discuss these exciting new opportunities in detail a bit later in the call, but I want to highlight that collectively they give AGTC one of the most diverse pipelines in the gene therapy space, and we believe that each of these programs provides the opportunity to significantly help patients and create value for