Applied Genetic Technologies Corp (AGTC) 10-K Annual Report Thu Sep 10 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

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.

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.

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.

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 18^th 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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Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

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

Exhibit 10.1: Material Contract

Exhibit 10.2: Material Contract

Exhibit 10.7: Material Contract

Exhibit 10.8: Material Contract

Exhibit 10.9: Material Contract

Exhibit 10.10: Material Contract

Exhibit 10.11: Material Contract

Exhibit 10.12: Material Contract

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

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

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