Applied Genetic Technologies Corporation (NASDAQ:AGTC) Q2 2019 Earnings Conference Call Transcript

Feb 07, 2019 • 08:00 am ET

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Applied Genetic Technologies Corporation (NASDAQ:AGTC) Q2 2019 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Good morning, and welcome to the AGTC Second Quarter Fiscal Year 2019 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 uncertainties 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 30, 2018.

For introductions and opening remarks, I would like to turn the call over to Sue Washer, Chief Executive Officer of AGTC. Please go ahead, Ms. Washer. You may begin.

Executive
Susan Washer

Good morning, and thank you all for joining us today.

With me this morning is Bill Sullivan, our Chief Financial Officer; and Matt Feinsod, our Chief Medical Officer. During today's call, Matt will provide a brief overview of our clinical and preclinical programs, and Bill will then review our financial results for the second quarter of fiscal year 2019. We will then be available to answer your questions.

AGTC's broad pipeline, combined with our strong financial position, affords us multiple opportunities for value inflection in 2019. And we remain confident in our ability to advance new treatment approaches for patients that today have few or no options. In December, we announced that we will regain rights to the X-linked retinitis pigmentosa or XLRP clinical program and three preclinical programs from Biogen, effective as of March 8, 2019.

We have received approximately $146 million from Biogen to date, all of which we will retain, and Biogen remains responsible for reimbursing costs related to our XLRP clinical program and certain other costs through March 8, 2019. We believe that regaining 100% control of these programs while retaining the progress that resulted from Biogen's investment will allow the Company more control and optionality to create value for AGTC, patients and shareholders as we continue to move our programs forward.

As Bill will discuss in a moment, we have a strong balance sheet with $96.1 million in cash, cash equivalents and investments on hand as of December 31, 2018. This gives us the financial resources to execute on our current and planned clinical trials as well as research and preclinical programs for at least the next two years, during which time we will have multiple data readouts from the achromatopsia and XLRP programs.

Top line interim six months data from the X-linked retinoschisis or XLRS trial demonstrated that our gene delivery platform is generally safe and well tolerated, but did not show evidence of clinical activity in either children or adults. While we were hopeful to see activity, the results of the study provide us with important insights that we believe are directly applicable to our other gene therapy trials. The