Applied Genetic Technologies Corp (AGTC) 10-Q Quarterly Report May 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:

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

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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:

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

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

Financial - Expense Highlight
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.

Revenue - Product Highlight
The increase in license and related services revenue was primarily due to recognizing revenue of $18.0 million as result of the termination of the Collaboration Agreement with Biogen effective March 8, 2019, partially offset by decreased license and related service revenue, when excluding amounts recognized upon the termination of the Collaboration Agreement, due to the Companys revised pattern of revenue recognition under ASC 606.
Financial - Expense Highlight
The decrease was primarily driven by lower employee-related costs and share-based based compensation of $0.3 million and lower other general and administrative expenses of $0.7 million attributable to decrease in bad debt expense and other administrative expenses incurred during normal business operation.
Financial - Expense Highlight
General and administrative expense General and administrative expense for the three months ended March 31, 2019 decreased by $0.8 million to $3.1 million compared to the same period in 2018.
Financial - Expense Highlight
General and administrative expense General and administrative expense for the nine months ended March 31, 2019 decreased by $1.7 million to $9.3 million compared to the same period in 2018.
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Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Material Contracts, Statements, Certifications & more

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

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-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