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Applied Genetic Technologies Corp (AGTC) SEC Filing 10-Q Quarterly Report for the period ending Thursday, March 31, 2022

Applied Genetic Technologies Corp

CIK: 1273636 Ticker: AGTC

Exhibit 99.1

AGTC Announces Financial Results and Business Update for the Quarter Ended December 31, 2021

-Company on track to provide 3-month interim SKYLINE trial results in 2Q 2022-

-Company to host management update and webcast today at 8:00 a.m. ET-

GAINESVILLE, Fla. and CAMBRIDGE, Mass., February 14, 2022 —

 Applied Genetic Technologies Corporation (Nasdaq: AGTC), a clinical stage biotechnology company focused on the development and commercialization of adeno-associated virus (AAV)-based gene therapies for the treatment of rare and debilitating diseases with an initial focus on inherited retinal diseases (IRDs), today announced financial results for the quarter ended December 31, 2021.

“We enter 2022 with significant momentum from the recent buildout of our management team, completion and reporting of several milestones, and updates on future milestones across our development pipeline, including key events for our achromatopsia and X-linked retinitis pigmentosa programs in the first half of the year,” said Sue Washer, President and CEO of AGTC. “In achromatopsia, we believe we have identified an appropriate dose for a potential Phase 2/3 trial in achromatopsia B3 program and intend to move that program forward subject to the receipt of end of phase 2 feedback from the FDA, expected in the first half of this year. In the second quarter, we expect to provide an update on our XLRP program with interim 3-month data from the SKYLINE trial. We believe both the XLRP and achromatopsia B3 programs have the potential to be best in class therapies for patients and are excited to move these important therapies one step closer to potential approval and commercialization. We are also seeing progress in our earlier stage programs in ophthalmology, otology and CNS and look forward to providing additional updates on each of those programs throughout the year in addition to the completion of our new manufacturing facility.”

Recent Highlights

AGTC-501 for X-linked Retinitis Pigmentosa (XLRP)

The Company is currently conducting multiple clinical trials of AGTC-501, its lead gene therapy development program for the treatment of XLRP, including the ongoing Phase 1/2 dose ranging trial, the Phase 2 SKYLINE trial, and the Phase 2/3 VISTA trial in support of a potential filing of a Biologics License Application (BLA). Earlier this year, the Company announced it had exceeded the enrollment target in the Company’s Phase 2 SKYLINE trial with a total of 14 patients enrolled across the high and low dose groups.

In May 2021, the Company reported positive 12-month data from the highest dose groups in the Phase 1/2 clinical trial, including 12-month data from Groups 5 and 6 that reflected a 50% response rate among patients who meet the inclusion criteria for the SKYLINE and VISTA trials. Based on the data generated to date, AGTC-501 also has a favorable safety profile. These data, together with the data presented at the Fourteenth International Symposium on Retinal Degeneration in September 2021 that indicated a correlation between improvements in macular structure and visual function, add to the growing body of evidence suggesting that AGTC-501 has the potential to be a best-in-class treatment for patients with XLRP.

 

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The following information was filed by Applied Genetic Technologies Corp (AGTC) on Monday, February 14, 2022 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Applied Genetic Technologies Corp's 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Cover Page
Condensed Balance Sheets (Unaudited)
Condensed Balance Sheets (Unaudited) (Parenthetical)
Condensed Statements Of Cash Flows (Unaudited)
Condensed Statements Of Operations (Unaudited)
Condensed Statements Of Stockholders' Equity (Unaudited)
Collaboration Agreements And Contract Liabilities
Collaboration Agreements And Contract Liabilities - Additional Information (Detail)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Detail)
Commitments And Contingencies - Schedule Of Rent Payable By Maturity (Detail)
Debt
Debt - Additional Information (Detail)
Investments And Fair Values Of Financial Instruments
Investments And Fair Values Of Financial Instruments (Tables)
Investments And Fair Values Of Financial Instruments - Additional Information (Detail)
Investments And Fair Values Of Financial Instruments - Schedule Of Major Category Of Company's Financial Assets And Liabilities Measured At Fair Value On Recurring Basis (Detail)
Organization And Operations
Organization And Operations - Additional Information (Detail)
Share-Based Compensation Plans
Share-Based Compensation Plans (Tables)
Share-Based Compensation Plans - Additional Information (Detail)
Share-Based Compensation Plans - Stock Option Pricing Model Assumption (Detail)
Share-Based Compensation Plans - Summary Of Stock Option Activity (Detail)
Stockholders' Equity
Stockholders' Equity - Additional Information (Detail)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies - Additional Information (Detail)

Material Contracts, Statements, Certifications & more

Applied Genetic Technologies Corp provided additional information to their SEC Filing as exhibits

Ticker: AGTC
CIK: 1273636
Form Type: 10-Q Quarterly Report
Accession Number: 0001193125-22-151743
Submitted to the SEC: Mon May 16 2022 4:15:51 PM EST
Accepted by the SEC: Mon May 16 2022
Period: Thursday, March 31, 2022
Industry: Biological Products No Disgnostic Substances

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