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Applied Genetic Technologies Corp (AGTC) SEC Filing 10-K Annual Report for the fiscal year ending Wednesday, June 30, 2021

Applied Genetic Technologies Corp

CIK: 1273636 Ticker: AGTC

Exhibit 99.1

AGTC Provides Financial Results for the Fourth Quarter and Year Ended June 30, 2021

-Data from ongoing clinical trials in XLRP and ACHM shows evidence of clinical activity and tolerability;

multiple data readouts expected in 2021 and 2022-

-Pre-Clinical programs moving to IND enabling animal studies-

-Company adds experienced industry veterans to board and management team-

-Company to host management update and webcast today at 4:30pm ET-

GAINESVILLE, Fla. and CAMBRIDGE, Mass., Sept. 23, 2021— Applied Genetic Technologies Corporation (Nasdaq: AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare inherited retinal diseases (IRDs), today announced financial results for the fourth quarter and fiscal year ended June 30, 2021.

“During the past 12 months, we made significant progress towards our corporate and clinical goals with the release of meaningful data in our two wholly-owned lead programs and the addition of key industry leaders to our board and executive team as we begin to plan for potential commercialization of these programs,” said Sue Washer, President and CEO of AGTC. “We expect the next 12 months to be a catalyst-rich period as we prepare for data readouts in the XLRP and ACHM programs, additional clinical data from our partnered optogenetics program and the advancement of one or more of our pre-clinical programs towards a potential IND filing.”

Recent Highlights

X-linked Retinitis Pigmentosa (XLRP)

Earlier in the year, the Company reported positive 12-month data from the highest dose groups in the Company’s ongoing XLRP Phase 1/2 clinical trial, including 12-month data from Groups 5 and 6 reflecting a 50% response rate among patients who meet the inclusion criteria for the Skyline and Vista trials and 24-month data from the two of three Group 4 patients providing preliminary evidence of response durability. The third patient was not a responder at month 12 and the Company is awaiting data on the remaining four Group 4 patients. Taken together, these data add to the body of evidence suggesting that durable improvements in visual sensitivity and visual acuity may be achieved in patients receiving AGTC’s XLRP product candidate while continuing to demonstrate a favorable safety profile.

The Company is currently conducting the Skyline and Vista Phase 2/3 clinical trials to support a potential filing of a biologics license application, or BLA.    Due to several challenges related to the COVID pandemic, including a greater than 50% patient screening cancellation rate in July and August, AGTC is amending its guidance on the three-month Skyline interim data release to the first half of 2022, but maintaining the six-month Vista interim data release for 4Q 2022.

In July 2021, The United States Adopted Name (USAN) Council notified the Company that it has formally assigned the USAN name laruparetigene zosaparvovec for its XLRP product candidate. Subject to positive data readouts in 2022, the Company intends to evaluate potential commercial or trade names for this product candidate.


The following information was filed by Applied Genetic Technologies Corp (AGTC) on Thursday, September 23, 2021 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Applied Genetic Technologies Corp's Definitive Proxy Statement (Form DEF 14A) filed after their 2021 10-K Annual Report includes:

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Inside Applied Genetic Technologies Corp's 10-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Cover Page
Balance Sheets
Balance Sheets (Parenthetical)
Statements Of Cash Flows
Statements Of Operations
Statements Of Stockholders' Equity
Accrued And Other Liabilities
Accrued And Other Liabilities (Tables)
Accrued And Other Liabilities - Additional Information (Detail)
Accrued And Other Liabilities - Schedule Of Accrued And Other Liabilities (Detail)
Collaboration Agreements, Revenue And Contract Liabilities
Collaboration Agreements, Revenue And Contract Liabilities - Additional Information (Detail)
Commitments And Contingencies
Commitments And Contingencies - Additional Information (Detail)
Debt
Debt - Additional Information (Detail)
Defined Contribution Plan
Defined Contribution Plan - Additional Information (Detail)
Fair Value Of Financial Instruments And Investments
Fair Value Of Financial Instruments And Investments (Tables)
Fair Value Of Financial Instruments And Investments - Additional Information (Detail)
Fair Value Of Financial Instruments And Investments - Schedule Of Major Category Of Company's Financial Assets And Liabilities Measured At Fair Value On Recurring Basis (Detail)
Income Taxes
Income Taxes (Tables)
Income Taxes - Additional Information (Detail)
Income Taxes - Reconciliation Of Income Tax Expense (Detail)
Income Taxes - Schedule Of Reconciliation Of The Unrecognized Tax Benefit (Detail)
Income Taxes - Significant Components Of Deferred Tax Assets And (Liabilities) (Detail)
Income Taxes - Summary Of Federal And State Income Tax Provision (Benefit) (Detail)
Intangible Assets, Net
Intangible Assets, Net (Tables)
Intangible Assets, Net - Additional Information (Detail)
Intangible Assets, Net - Schedule Of Estimated Amortization Expense (Detail)
Intangible Assets, Net - Schedule Of Intangible Assets, Net As Of The Dates Indicated (Detail)
Investments
Investments (Tables)
Investments - Summary Of Company's Debt Securities Held-To-Maturity (Detail)
Leases
Leases (Tables)
Leases - Additional Information (Detail)
Leases - Summary Of Company Annual Base Rent (Detail)
Leases - Summary Of Company Annual Base Rent (Parenthetical) (Detail)
Leases - Summary Of Future Minimum Commitments For The Company's Operating And Financing Leases (Detail)
Leases - Summary Of Lease Costs And Other Information Pertaining To The Company's Operating And Finance Leases (Detail)
Organization And Operations
Organization And Operations - Additional Information (Detail)
Property And Equipment, Net
Property And Equipment, Net (Tables)
Property And Equipment, Net - Additional Information (Detail)
Property And Equipment, Net - Components Of Property And Equipment (Detail)
Quarterly Financial Information
Quarterly Financial Information (Tables)
Quarterly Financial Information - Summary Of Quarterly 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)
Share-Based Compensation Plans - Summary Of Stock Options Exercisable, And Vested And Expected To Vest (Detail)
Share-Based Compensation Plans - Summary Of Total Share-Based Expense Associated With Stock Options And Restricted Shares (Detail)
Stockholders' Equity And Related Matters
Stockholders' Equity And Related Matters (Tables)
Stockholders' Equity And Related Matters - Additional Information (Detail)
Stockholders' Equity And Related Matters - Shares Of Common Stock Reserved For Future Issuance (Detail)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies - Additional Information (Detail)
Ticker: AGTC
CIK: 1273636
Form Type: 10-K Annual Report
Accession Number: 0001193125-21-280686
Submitted to the SEC: Thu Sep 23 2021 4:13:44 PM EST
Accepted by the SEC: Thu Sep 23 2021
Period: Wednesday, June 30, 2021
Industry: Biological Products No Disgnostic Substances

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