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Applied Genetic Technologies Corp (AGTC) SEC Filing 10-Q Quarterly report for the period ending Sunday, March 31, 2019

Applied Genetic Technologies Corp

CIK: 1273636 Ticker: AGTC

Exhibit 99.1

 

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AGTC Announces Financial Results and Business Update for the Quarter Ended March 31, 2019

GAINESVILLE, Fla., and CAMBRIDGE, Mass., May 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 March 31, 2019.

“Completing enrollment in the dose escalation portion of our Phase 1/2 trial in patients with achromatopsia due to mutations in the CNGB3 gene and the expansion cohort of our Phase 1/2 trial in patients with X-linked retinitis pigmentosa demonstrates our clinical development progress and keeps us on track to report multiple data sets in the second half of 2019,” said Sue Washer, President and CEO of AGTC. “Achieving these clinical milestones reflects our continued progress and commitment to developing new approaches to treat inherited retinal diseases positioning AGTC well to create value for patients and shareholders.”

AGTC Clinical Program Update

AGTC remains on track to meet its current enrollment milestones across its three Phase 1/2 clinical programs:

X-linked Retinitis Pigmentosa (XLRP) Phase 1/2 Clinical Trial

To date, AGTC has completed enrollment of ten patients in the dose escalation portion of the XLRP trial and six patients in the expansion portion of the trial. The Company expects to:

 

   

Provide interim six-month data for the dose escalation group in the third quarter of 2019; and

 

   

Provide interim six-month data for the expansion group in the fourth quarter of 2019.

Achromatopsia (ACHM) Phase 1/2 Clinical Trials

The Company is enrolling patients in two parallel Phase 1/2 clinical trials of its product candidates for ACHM caused by mutations in the two most common ACHM genes, CNGB3 and CNGA3. To date, AGTC has enrolled twelve patients in the ACHM CNGB3 trial and seven patients in the ACHM CNGA3 trial. The Company expects to:

 

   

Complete enrollment of the dose escalation portion of the CNGA3 trial in the second quarter of 2019;

 

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The following information was filed by Applied Genetic Technologies Corp (AGTC) on Tuesday, May 7, 2019 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-Q Quarterly 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 2019 10-K Annual Report includes:

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Inside Applied Genetic Technologies Corp's 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Condensed Balance Sheets (Unaudited)
Condensed Balance Sheets (Unaudited) (Parenthetical)
Condensed Statement Of Stockholders' Equity (Unaudited)
Condensed Statements Of Cash Flows (Unaudited)
Condensed Statements Of Operations (Unaudited)
Collaboration Agreement
Collaboration Agreement (Tables)
Collaboration Agreement - Components Of Collaboration Revenue (Detail)
Collaboration Agreement - Summary Of Performance Obligations And Transaction Price (Detail)
Collaboration Agreements - Additional Information (Detail)
Collaboration Agreements - Summary Of Changes In Contract Assets And Liabilities (Detail)
Fair Value Of Financial Instruments And Investments
Fair Value Of Financial Instruments And Investments (Tables)
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)
Investments
Investments (Tables)
Investments - Summary Of Company's Debt Securities Held-To-Maturity (Detail)
Investments - Summary Of Company's Investments (Detail)
Organization And Operations
Organization And Operations - Additional 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)
Summary Of Significant Accounting Policies - Additional Information (Detail)
Summary Of Significant Accounting Policies:
Summary Of Significant Accounting Policies: (Policies)

Material Contracts, Statements, Certifications & more

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: 0001193125-19-139735
Submitted to the SEC: Tue May 07 2019 12:33:07 PM EST
Accepted by the SEC: Tue May 07 2019
Period: Sunday, March 31, 2019
Industry: Biological Products No Disgnostic Substances

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