Applied Genetic Technologies Corporation

Net loss for the three months ended December 31, 2021 was $19.1 million, versus $15.5 million in the prior-year period. Net loss for the six months ended December 31, 2021 was $36.3 million, versus $30.8 million in the prior-year period. Cash, cash equivalents and investments were $72.8 million as of December 31, 2021. Management said those funds should support ongoing and planned clinical programs and planned research and discovery programs into calendar year 2023. Forward milestones include SKYLINE three-month interim data in the second quarter of calendar year 2022, 12-month SKYLINE and interim VISTA results in the first half of calendar year 2023, and end-of-Phase-2 feedback for achromatopsia in the first half of 2022.

Sue Washer emphasized that AGTC made significant progress in its lead clinical programs and said the body of data to date increases confidence in both AGTC-501 for XLRP and AGTC-401 for achromatopsia B3. She highlighted the expanded management team, the addition of a Board member with commercial experience, and the company’s intent to move both programs toward late-stage development and possible commercialization. Her tone was upbeat but data-driven, repeatedly tying success to upcoming readouts and FDA interactions.

Jon Lieber said construction of the new lease manufacturing and quality control facility is underway and initial operations are expected in the fourth quarter of calendar year 2022. On the financials, he reported a $19.1 million quarterly net loss and $36.3 million six-month net loss, both larger than the comparable 2020 periods, and said AGTC ended the quarter with $72.8 million in cash, cash equivalents and investments. He said the company expects those funds to last into calendar year 2023 and noted hiring for the manufacturing facility should continue, but at a slower pace than in the prior year.

Analysts focused on the SKYLINE maze endpoint, the bar for success in visual sensitivity and BCVA, and whether VISTA or achromatopsia development plans might change based on interim data. Management said the maze uses multiple standardized configurations to reduce learning effects, that visual sensitivity success is tied to a seven-decibel change in at least five loci, and that BCVA response is defined as a five-letter improvement. On VISTA, management said it is not waiting for SKYLINE to start and that any design adjustments would depend on data and FDA discussion, while for achromatopsia they said an end-of-Phase-2 meeting is scheduled and they expect to update the public by the end of June.