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AGTC Announces Financial Results and Business Update for the Quarter and Fiscal Year Ended June 30, 2017
GAINESVILLE, Fla., and CAMBRIDGE, Mass., September 13, 2017 Applied Genetic Technologies Corporation (NASDAQ: AGTC), a clinical-stage biotechnology company that uses its proprietary gene therapy platform to develop transformational genetic therapies for patients suffering from rare and debilitating diseases, today announced financial results for the quarter and fiscal year ended June 30, 2017.
AGTCs lead product candidates are designed to treat inherited orphan diseases of the eye, caused by mutations in single genes that significantly affect visual function and currently lack effective medical treatments. AGTCs pipeline includes clinical-stage ophthalmology programs in X-linked retinoschisis (XLRS), achromatopsia (ACHM) caused by mutations in the CNGB3 and CNGA3 genes, and X-linked retinitis pigmentosa (XLRP) as well as a preclinical optogenetics program.
|||In June, the company announced topline safety data for the dose escalation phase of the companys Phase 1/2 XLRS clinical trial.|
|||Also in June, Investigational New Drug application (IND)-enabling preclinical data for the companys gene therapy product candidate to treat ACHM due to mutations in the CNGA3 gene was published in Human Gene Therapy Clinical Development.|
|||In August, the U.S. Food and Drug Administration (FDA) granted orphan drug designation for AGTCs gene therapy product candidate for the treatment of XLRP.|
|||Also in August, the company filed an IND with the FDA to support initiation of a Phase 1/2 clinical trial of the companys gene therapy product candidate for XLRP.|
|||The company appointed William Sullivan as Chief Financial Officer and Andrew Ashe as General Counsel. Both Mr. Sullivan and Mr. Ashe are industry veterans with more than 20 years of financial and life sciences leadership experience.|
|||AGTC and the Foundation Fighting Blindness (FFB) announced a partnership agreement to support the organizations shared mission to advance gene therapy research to treat inherited retinal diseases through expanded patient genotyping and registry efforts.|
We remain focused on the ongoing clinical advancement of our XLRS and ACHM studies. Completing the dose escalation phase of our Phase 1/2 trial in XLRS and continuing site initiation and patient enrollment in the Phase 1/2 trials of our ACHM programs demonstrate our commitment to accelerate the clinical development of our product candidates, said Sue Washer, President and CEO of AGTC. This is further demonstrated by the progress of our XLRP program, where we have received orphan drug designation from the FDA, published important work on the design of the product and recently filed an IND application. Now that our IND has been filed and cleared by the FDA, we expect to initiate patient enrollment in the XLRP program in the first quarter of 2018 and look forward to expanding our clinical pipeline.
The following information was filed by Applied Genetic Technologies Corp (AGTC) on Wednesday, September 13, 2017 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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