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Applied Genetic Technologies Corp (AGTC) SEC Filing 10-K Annual report for the fiscal year ending Tuesday, June 30, 2015

Applied Genetic Technologies Corp

CIK: 1273636 Ticker: AGTC

Exhibit 99.1

 

AGTC Announces Financial Results for the Quarter and Fiscal Year Ended June 30, 2015

 

GAINESVILLE, Fla., (September 10, 2015) – Applied Genetic Technologies Corporation (NASDAQ: AGTC), a clinical stage biotechnology company developing adeno-associated virus (AAV)-based gene therapies for the treatment of rare eye diseases, today announced financial results for the quarter and fiscal year ended June 30, 2015.

 

“This has been an exciting and transformative period for AGTC,” said Sue Washer, President and CEO. “In addition to commencing enrollment in our clinical trial for XLRS, our recent collaboration with Biogen will enable us to expedite development of our lead programs as well as advance additional therapeutic targets that are in our pipeline. As we continue to expand our pipeline and bring additional programs into the clinic, we are confident that our thorough, rational approach to product candidate selection as well as our expanded team and capabilities will continue to distinguish AGTC as a leader in ophthalmology gene therapy.”

 

Recent Highlights

 

 

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Earlier this month, the company announced the opening of a second U.S. location in Cambridge, Massachusetts.  The new location, consisting of office and laboratory space, will focus on business development, pharmacology and basic research and development.

 

 

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In July, the company announced a broad collaboration and license agreement with Biogen under which it received up-front payments of $124 million in August, including a $30 million equity investment in AGTC by Biogen. The collaboration covers the development of gene-based therapies for multiple ophthalmic diseases with a focus on the development of a portfolio of AGTC’s therapeutic programs, including both a clinical stage candidate and a pre-clinical candidate for orphan diseases of the retina that can lead to blindness in children and adults. The agreement also includes options for early stage discovery programs in two ophthalmic diseases and one non-ophthalmic condition, and a license agreement for manufacturing rights.  In August, the company achieved the first milestone under the Biogen collaboration for X-linked retinoschisis (XLRS) clinical trial enrollment, which triggers an additional $5 million payment.

 

 

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In June, there were two key additions to its senior management team: Mark Shearman, Ph.D. was appointed Chief Scientific Officer and Rabia Ozden, M.D. was appointed Vice President of Clinical Research and Development.

 

 

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In May, the company announced new preclinical data which further supports the safety of its AAV vector gene therapies for the treatment of achromatopsia (ACHM) and XLRS. Additionally, new safety data were presented on AGTC's proprietary manufacturing process. Study results were presented at the 18th annual meeting of the American Society of Gene & Cell Therapy.

 

Financial Results for the Quarter Ended June 30, 2015

 

Total revenue for the three months ended June 30, 2015 increased by $589,000 to $713,000 compared to the same period in 2014.  The increase was driven by higher grant and sponsored research revenue, triggered primarily by the approval of the company’s Investigational New Drug (IND) application for XLRS that was filed with the U.S. Food and Drug Administration (FDA) in March 2015.

 

Research and development expense for the three months ended June 30, 2015 increased by $1.9 million to $4.6 million compared to the same period in 2014.  The increase was primarily the result of increased research and development activity relating to the company’s XLRS, ACHM, X-linked retinitis pigmentosa (XLRP), and other product candidates. In addition, employee-related costs were up compared to the same period last year due largely


The following information was filed by Applied Genetic Technologies Corp (AGTC) on Thursday, September 10, 2015 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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Inside this 10-K Annual Report

Document And Entity Information
Schedule Ii - Valuation And Qualifying Accounts (detail)
Balance Sheets
Balance Sheets (parenthetical)
Statements Of Cash Flows
Statements Of Operations
Statements Of Stockholders' Equity (deficit)
Accrued Expenses
Accrued Expenses (tables)
Accrued Expenses - Schedule Of Accrued Expenses (detail)
Commitments And Contingencies
Commitments And Contingencies (tables)
Commitments And Contingencies - Additional Information (detail)
Commitments And Contingencies - Future Annual Minimum Lease Payments Under Non-cancelable Operating Leases (detail)
Common Stock And Stockholders' Equity
Common Stock And Stockholders' Equity (tables)
Common Stock And Stockholders' Equity - Additional Information (detail)
Common Stock And Stockholders' Equity - Shares Of Common Stock Reserved For Future Issuance (detail)
Defined Contribution Plan
Defined Contribution Plan - Additional Information (detail)
Fair Value Measurements
Fair Value Measurements (tables)
Fair Value Measurements - 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 - Significant Components Of Deferred Tax Assets And (liabilities) (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 Subject To Amortization (detail)
Investment - Summary Of Debt Securities Held-to-maturity (detail)
Investments
Investments (tables)
Investments - Summary Of Amortized Cost And Fair Value Of Held-to-maturity Debt Securities (detail)
Investments - Summary Of Company's Investments (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)
Schedule Ii-valuation And Qualifying Accounts
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 Outstanding And Exercisable (detail)
Share-based Compensation Plans - Summary Of Total Share-based Expense Associated With Stock Options And Restricted Shares (detail)
Subsequent Events
Subsequent Events - Additional Information (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: 0001564590-15-007858
Submitted to the SEC: Thu Sep 10 2015 4:04:29 PM EST
Accepted by the SEC: Thu Sep 10 2015
Period: Tuesday, June 30, 2015
Industry: Biological Products No Disgnostic Substances

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