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Exhibit 99.1
AGTC Provides Financial Results for the Fourth Quarter and Year Ended June 30, 2021
-Data from ongoing clinical trials in XLRP and ACHM shows evidence of clinical activity and tolerability;
multiple data readouts expected in 2021 and 2022-
-Pre-Clinical programs moving to IND enabling animal studies-
-Company adds experienced industry veterans to board and management team-
-Company to host management update and webcast today at 4:30pm ET-
GAINESVILLE, Fla. and CAMBRIDGE, Mass., Sept. 23, 2021 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 inherited retinal diseases (IRDs), today announced financial results for the fourth quarter and fiscal year ended June 30, 2021.
During the past 12 months, we made significant progress towards our corporate and clinical goals with the release of meaningful data in our two wholly-owned lead programs and the addition of key industry leaders to our board and executive team as we begin to plan for potential commercialization of these programs, said Sue Washer, President and CEO of AGTC. We expect the next 12 months to be a catalyst-rich period as we prepare for data readouts in the XLRP and ACHM programs, additional clinical data from our partnered optogenetics program and the advancement of one or more of our pre-clinical programs towards a potential IND filing.
Recent Highlights
X-linked Retinitis Pigmentosa (XLRP)
Earlier in the year, the Company reported positive 12-month data from the highest dose groups in the Companys ongoing XLRP Phase 1/2 clinical trial, including 12-month data from Groups 5 and 6 reflecting a 50% response rate among patients who meet the inclusion criteria for the Skyline and Vista trials and 24-month data from the two of three Group 4 patients providing preliminary evidence of response durability. The third patient was not a responder at month 12 and the Company is awaiting data on the remaining four Group 4 patients. Taken together, these data add to the body of evidence suggesting that durable improvements in visual sensitivity and visual acuity may be achieved in patients receiving AGTCs XLRP product candidate while continuing to demonstrate a favorable safety profile.
The Company is currently conducting the Skyline and Vista Phase 2/3 clinical trials to support a potential filing of a biologics license application, or BLA. Due to several challenges related to the COVID pandemic, including a greater than 50% patient screening cancellation rate in July and August, AGTC is amending its guidance on the three-month Skyline interim data release to the first half of 2022, but maintaining the six-month Vista interim data release for 4Q 2022.
In July 2021, The United States Adopted Name (USAN) Council notified the Company that it has formally assigned the USAN name laruparetigene zosaparvovec for its XLRP product candidate. Subject to positive data readouts in 2022, the Company intends to evaluate potential commercial or trade names for this product candidate.
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Applied Genetic Technologies Corp's Definitive Proxy Statement (Form DEF 14A) filed after their 2021 10-K Annual Report includes:
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The decrease in ACHM expenses was primarily due to reduced patient enrollment, patient visits and new site activations during the year ended June 30, 2021 when compared to the prior year, all of which reduce our overall clinical programs costs, partially offset by incremental expenses for our mobile vision center.
We do not allocate employee-related costs, including share-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.
Most recently, we received: (i) $34.8 million of proceeds from the issuance of our common stock, net of issuance costs, in February 2020; (ii) $9.9 million of loan proceeds, net of debt discounts, during each of June 2020 and May 2021; and (iii) net proceeds of $69.3 million in February 2021 from the underwritten public offering that is described above under "Recent Developments."
Such increase was primarily attributable to: $8.8 million of increased external spending for our XLRP trials due to our planned manufacturing, clinical site preparation and other activities related to our Skyline and Vista trials; $1.0 million of increased external spending for our research and discovery programs, which was primarily due to planned material production costs in connection with our CNS preclinical program targeting FTD; and $0.6 million of increased other internal research and development expenses for temporary staffing and consultants while we recruit new employees, partially offset by a reduction in laboratory supply costs due to the timing of our needs.
Promised goods or services are considered distinct when (i) the customer can benefit from the good or service on its own or together with other readily available resources and (ii) the promised good or service is separately identifiable from other promises in the contract.
Secondary endpoints include mean change...Read more
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Consistent with previously reported 6-month...Read more
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Data from three of the...Read more
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Seven of the 16 patients...Read more
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None of these three patients...Read more
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Data from all 28 patients...Read more
Importantly, through a tenant improvement...Read more
To date, we have not...Read more
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Retinal sensitivity, as measured by...Read more
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Moreover, we may need to...Read more
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We generate revenue primarily through:...Read more
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Our optogenetics program is being...Read more
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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-K Annual Report
Accession Number: 0001193125-21-280686
Submitted to the SEC: Thu Sep 23 2021 4:13:44 PM EST
Accepted by the SEC: Thu Sep 23 2021
Period: Wednesday, June 30, 2021
Industry: Biological Products No Disgnostic Substances