Applied Genetic Technologies Corporation (NASDAQ:AGTC) Q4 2020 Earnings Conference Call - Final Transcript
Sep 09, 2020 • 08:00 am ET
Good morning, and welcome to the AGTC Fourth Quarter and 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, including statements about its planned Phase 2/3 clinical trial.
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, the extent and duration of the impact of the COVID-19 pandemic, and other risks described in Risk Factors section of AGTC's most recently filed annual report on Form 10-K and other periodic reports filed with the SEC. AGTC undertakes no obligations to update any forward-looking statements after the date of this call.
For introductions and opening remarks, I'd like to turn the call over to Sue Washer, Chief Executive Officer of AGTC. Ms. Washer, please go ahead.
Good morning, and thank you all for joining us. With me on today's call are Bill Sullivan, our Chief Financial Officer; and Mark Shearman, Chief Scientific Officer.
Today, we will begin by providing a management update on our plans for our X-linked retinitis pigmentosa or XLRP clinical program and a brief overview of our other activities.
Next, Mark will review our clinical programs with additional details on our XLRP Phase 2/3 plans based on FDA feedback, as well as new preliminary data for the higher dose Group 5 from the ongoing Phase 1/2 trial review our preclinical pipeline, and then Bill will review our fourth quarter and fiscal year-end 2020 financial results. We will then take your questions.
I would like to begin today's call by noting that we have achieved several critical milestones. As we announced in July, the FDA provided a comprehensive written feedback on our End of Phase 2 submission regarding the protocol design and conduct of our next trial to support future regulatory submissions related to our clinical program and patients with XLRP due to mutations in the RPGR gene.
We continue to move forward as planned with manufacturing, clinical site preparation and other activities to enable initiation of a Phase 2/3 study in the first quarter of 2021. Mark will provide additional information about the expected design of the Phase 2/3 trial a bit later in the call.
In parallel, we plan to expand the ongoing Phase 1/2 trial in order to dose approximately 12 patients in two randomized and masked dosing arms to collect additional data, including a functional mobility course added as a supplemental endpoint. This type of mobility course was used to support FDA approval of Luxturna, the first gene therapy for an inherited retinal disease.
We have already begun prescreening additional patients and expect to begin enrolling in the fourth quarter of 2020. Mark will also provide details on new preliminary data for the