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Exhibit 99.1
AGTC Announces Financial Results and Business Update for the Quarter Ended December 31, 2018
GAINESVILLE, Fla., and CAMBRIDGE, Mass., February 7, 2019 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 diseases, today announced financial results for the quarter ended December 31, 2018.
AGTC is positioned for significant progress in 2019, including data readouts from our achromatopsia B3, achromatopsia A3 and X-linked retinitis pigmentosa clinical trials, said Sue Washer, President and CEO of AGTC. We also expect that our optogenetics partner, Bionic Sight, will file an Investigational New Drug application with the U.S. Food and Drug Administration in the first half of 2019. This diverse pipeline, combined with our strong financial position, affords us multiple opportunities to advance new approaches for patients experiencing vision loss that today have few or no treatment options.
AGTC Clinical Program Update
AGTC continues to enhance its clinical infrastructure resulting in the acceleration of clinical enrollment in all the Companys ongoing clinical trials. These resources have allowed AGTC to expand patient recruitment efforts, introduce new clinical trial sites, conduct surgical training and enhance clinical site support.
X-linked Retinitis Pigmentosa (XLRP) Phase 1/2 Clinical Trial
AGTC completed enrollment of the nine patients in the dose escalation portion of the Phase 1/2 clinical trial of its product candidate for XLRP in December and has also treated three patients in the expansion group of the Phase 1/2 clinical trial. The Company expects to:
| Complete enrollment in the expansion group of the trial in the first quarter of 2019; |
| Provide interim six-month data on the dose escalation portion of the trial in the third quarter of 2019; and |
| Provide interim six-month data on the expansion group portion of the trial in the fourth quarter of 2019. |
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Applied Genetic Technologies Corp's Definitive Proxy Statement (Form DEF 14A) filed after their 2019 10-K Annual Report includes:
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We do not allocate personnel-related costs, including stock-based compensation, costs associated with broad technology platform improvements or other indirect costs, to specific programs, as they are deployed across multiple projects under development and, as such, are separately classified as internal research and development expenses in the table above.
General and administrative expense General and administrative expense for the three months ended December 31, 2018 decreased by $0.3 million to $3.0 million compared to the same period in 2017.
General and administrative expense General and administrative expense for the six months ended December 31, 2018 decreased by $0.8 million to $6.2 million compared to the same period in 2017.
The increase in license and related service revenue was due to the Companys revised pattern of revenue recognition under Topic 606.
For the three months ended December 31, 2018, license and related services, which includes the Pre-Funded Activities associated with each program under the Biogen Collaboration, are recognized on a proportional performance basis under Topic 606.
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Financial Statements, Disclosures and Schedules
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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: 0001193125-19-030848
Submitted to the SEC: Thu Feb 07 2019 11:06:34 AM EST
Accepted by the SEC: Thu Feb 07 2019
Period: Monday, December 31, 2018
Industry: Biological Products No Disgnostic Substances