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Archive for September, 2021

AGTC Clinical Trial Investigators to Present Data from Ongoing XLRP and Achromatopsia Phase 1/2 Trials at the Fourteenth International Symposium on Retinal Degeneration

September 28, 2021 at 8:00 AM EDT

Dr. Rachel Huckfeldt and Dr. Paul Yang to Present 12-Month Findings and Analysis from AGTC’s Clinical Trials
GAINESVILLE, Fla. and CAMBRIDGE, Mass., Sept. 28, 2021 (GLOBE NEWSWIRE) — 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, today announced a presentation of the Company’s ongoing clinical trials in achromatopsia (ACHM) and X-linked retinitis pigmentosa (XLRP) at the Fourteenth International Symposium on Retinal Degeneration (RD2021).

Rachel Huckfeldt, MD, PhD, Assistant Professor of Ophthalmology at Harvard Medical School will present Twelve-month Findings from Two Phase 1/2 Clinical Trials of Subretinal Gene Therapy for Achromatopsia in adults and low-dose pediatrics on September 29, 2021, at 9:35 AM ET.

Paul Yang, MD, PhD, Assistant Professor of Ophthalmology at the Casey Eye Institute, Oregon Health & Science University in Portland, will present Twelve-Month Analysis of Macular Structure using Optical Coherence Tomography (OCT) from a Phase 1/2 Clinical Study of Subretinal Gene Therapy Drug AGTC-501 for X-Linked Retinitis Pigmentosa, on September 29, 2021, at 10:35 AM ET.

“We look forward to our investigators having the opportunity to share analysis of these results with members of the eye health community,” said Sue Washer, President and CEO of AGTC. “We believe the data provide important validation for the broad application of our AAV technology platform, including the best-in-class potential for our XLRP therapy candidate and further clinical investigation of our therapy to treat ACHM.”

“ACHM is an inherited condition caused by mutations in one of several genes, including the CNGB3 or CNGA3 genes, resulting in nonfunctioning “cone” photoreceptors responsible for color vision, and is associated with poor visual acuity, extreme light sensitivity leading to daytime blindness, and partial or complete loss of color discrimination,” said Dr. Huckfeldt. “These results are very encouraging, and I look forward to sharing them with my fellow retinal specialists.”

“Patients with XLRP experience damage to photoreceptors in the retina (both rods and cones) leading to declining vision in dim light conditions and progressive peripheral vision loss that can eventually result in legal blindness,” said Dr. Yang. “The sustained durability of improved visual function over 12 months is compelling evidence of biological activity for this XLRP gene therapy.”

AGTC plans to advance its ACHM program to the next stage of clinical development and is moving forward on an End-of-Phase 2 (EOP2) briefing packet to submit to the U.S. Food and Drug Administration, developing assays for pivotal ready testing, and planning production of clinical trial material. Along with the 12-month results in XLRP and other key XLRP data previously released by the company, AGTC is currently executing the Skyline and Vista Phase 2/3 trials that will expand safety and efficacy analyses, including microperimetry and luminance mobility maze outcomes.

Learn more and register here for the virtual/digital event to attend these important presentations: https://bit.ly/3z9uHre.

About AGTC
AGTC is a clinical-stage biotechnology company developing genetic therapies for people with rare and debilitating ophthalmic, otologic and central nervous system (CNS) diseases. AGTC is a leader in designing and constructing all critical gene therapy elements and bringing them together to develop customized therapies that address real patient needs. AGTC’s most advanced clinical programs leverage its best-in-class technology platform to potentially improve vision for patients with an inherited retinal disease. AGTC has active clinical trials in X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHMB3 and ACHMA3). Its preclinical programs build on the Company’s industry leading AAV manufacturing technology and scientific expertise. AGTC is advancing multiple important pipeline candidates to address substantial unmet clinical need in optogenetics, otology and CNS disorders. In recent years AGTC has entered into strategic partnerships with companies including Otonomy, Inc., a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, and Bionic Sight, LLC, an innovator in the emerging field of optogenetics and retinal coding.

Forward-Looking Statements
This release contains forward-looking statements that reflect AGTC’s plans, estimates, assumptions and beliefs, including statements about the potential of the Company’s late-stage development programs in X-Linked Retinitis Pigmentosa (XLRP) and Achromatopsia (ACHM). Forward-looking statements include information concerning possible or assumed future results of operations, financial guidance, business strategies and operations, preclinical and clinical product development and regulatory progress, potential growth opportunities, potential market opportunities, the effects of competition and the impact of the COVID-19 pandemic, including the impact on its ability to obtain the raw materials necessary to conduct its clinical trials. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “seeks,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Actual results could differ materially from those discussed in the forward-looking statements, due to a number of important factors. Risks and uncertainties that may cause actual results to differ materially include, among others: gene therapy is still novel with only a few approved treatments so far; AGTC cannot predict when or if it will obtain regulatory approval to commercialize a product candidate or receive reasonable reimbursement; uncertainty inherent in clinical trials and the regulatory review process; risks and uncertainties associated with drug development and commercialization; the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations, and financial condition; factors that could cause actual results to differ materially from those described in the forward-looking statements are set forth under the heading “Risk Factors” in our most recent annual report on Form 10-K and subsequent periodic reports filed with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent management’s plans, estimates, assumptions and beliefs only as of the date of this release. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

PR Contact:
Bryan Blatstein
Spectrum Science Communications
T: (212) 468-5379 or (917) 714-2609
[email protected]

Corporate Contact:
Stephen Potter
Chief Business Officer
Applied Genetic Technologies Corporation
T: (617) 413-2754
[email protected]

 


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Source: Applied Genetic Technologies Corporation

AGTC to Host Fourth Quarter and 2021 Fiscal Year End Financial Results Conference Call and Webcast on September 23, 2021

September 16, 2021 at 8:00 AM EDT

GAINESVILLE, Fla. and CAMBRIDGE, Mass., Sept. 16, 2021 (GLOBE NEWSWIRE) — 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 that it will report financial results for the quarter and year ended June 30, 2021 after the market closes on Thursday, September 23, 2021. AGTC management will host a conference call beginning at 4:30 PM Eastern Time on the same date to review results and provide a corporate update.

To access the call, dial (844) 646-2697 (US) or (918) 922-6902 (outside of the US). A live webcast will be available in the Events and Presentations section of the Investor Relations page at http://ir.agtc.com/events-and-presentations. Please log in approximately 10 minutes prior to the scheduled start time. The archived webcast will be available in the Events and Presentations section of the company’s website.

About AGTC

AGTC is a clinical-stage biotechnology company developing genetic therapies for people with rare and debilitating ophthalmic, otologic and central nervous system (CNS) diseases. AGTC is a leader in designing and constructing all critical gene therapy elements and bringing them together to develop customized therapies with the potential to address real patient needs. AGTC’s most advanced clinical programs leverage its best-in-class technology platform to potentially improve vision for patients with an inherited retinal disease. AGTC has active clinical trials in X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM CNGB3 and ACHM CNGA3). Its preclinical programs build on the Company’s industry leading AAV manufacturing technology and scientific expertise. AGTC is also advancing multiple important pipeline candidates to address substantial unmet clinical need in optogenetics, otology and CNS disorders, including entering into strategic partnerships with companies including Otonomy, Inc., a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, and Bionic Sight, LLC, an innovator in the emerging field of optogenetics and retinal coding.

IR CONTACT:

Jonathan Nugent

Stern IR

T: 212-698-8698

[email protected]

Corporate Contacts:

Stephen Potter

Chief Business Officer

Applied Genetic Technologies Corporation

T: (617) 413-2754

[email protected]

 


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Source: Applied Genetic Technologies Corporation

AGTC to Participate in Clinical Trials in Rare Diseases Conference Panel and Case Study

September 9, 2021 at 8:00 AM EDT

AGTC patient advocacy executive director and director of patient enrollment to speak at Clinical Trials in Rare Diseases Conference

GAINESVILLE, Fla. and CAMBRIDGE, Mass., Sept. 09, 2021 (GLOBE NEWSWIRE) — 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 that Jill Dolgin, PharmD, Executive Director of Global Patient Advocacy, and Halley Losekamp, Director of Patient Enrollment, will participate as speakers at the Clinical Trials in Rare Diseases Conference, September 14, 2021 starting at 9 AM ET.

Dr. Dolgin will join Stephanie Kalley of Crinetics Pharmaceuticals, Wendy Erler of Alexion Pharmaceuticals, and a senior representative of Scout Clinical to discuss how to work effectively with patients and advocacy groups to ensure studies are accessible and of maximum benefit to patients. This panel discussion will be moderated by a senior representative of GlobalData. Ms. Losekamp will present a case study on patient recruitment and retention in a rare disease setting.

“AGTC understands the need for and benefit of accessible and diverse studies that facilitate trial accessibility for all potential participants,” said Dr. Dolgin. “It is an honor to join a panel of industry experts to address how we can work better with patients and advocacy groups to create inclusive, diverse, and accessible studies to maximize the potential for patient benefits.”

“Our clinical trial and patient recruitment work at AGTC has provided us with many perspectives on how to recruit and retain patients in a rare disease setting,” said Ms. Losekamp. “AGTC is excited to share our work and lessons learned in patient recruitment, including virtual recruitment and factors to take into account to improve patient experience, especially during the COVID-19 pandemic.”

Dr. Dolgin’s panel entitled, “Working effectively with patients and advocacy groups to ensure your study is accessible and of maximum benefit to patients,” begins at 11:15 AM ET, and Ms. Losekamp’s case study entitled, “Patient recruitment and retention in a rare disease setting,” begins at 1:30 PM ET. To register for the event, visit https://bit.ly/3ywCb7j.

About AGTC
AGTC is a clinical-stage biotechnology company developing genetic therapies for people with rare and debilitating ophthalmic, otologic and central nervous system (CNS) diseases. AGTC is a leader in designing and constructing all critical gene therapy elements and bringing them together to develop customized therapies that address real patient needs. AGTC’s most advanced clinical programs leverage its best-in-class technology platform to potentially improve vision for patients with an inherited retinal disease. AGTC has active clinical trials in X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM CNGB3 and ACHM CNGA3). Its preclinical programs build on the Company’s industry leading AAV manufacturing technology and scientific expertise. AGTC is advancing multiple important pipeline candidates to address substantial unmet clinical need in optogenetics, otology and CNS disorders. In recent years AGTC has entered into strategic partnerships with companies including Otonomy, Inc., a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, and Bionic Sight, LLC, an innovator in the emerging field of optogenetics and retinal coding.

Forward-Looking Statements

This release contains forward-looking statements that reflect AGTC’s plans, estimates, assumptions and beliefs, including statements about the potential of the Company’s late-stage development programs in X-Linked Retinitis Pigmentosa (XLRP) and Achromatopsia (ACHM). Forward-looking statements include information concerning possible or assumed future results of operations, financial guidance, business strategies and operations, preclinical and clinical product development and regulatory progress, potential growth opportunities, potential market opportunities, the effects of competition and the impact of the COVID-19 pandemic, including the impact on its ability to obtain the raw materials necessary to conduct its clinical trials. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “seeks,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Actual results could differ materially from those discussed in the forward-looking statements, due to a number of important factors. Risks and uncertainties that may cause actual results to differ materially include, among others: gene therapy is still novel with only a few approved treatments so far; AGTC cannot predict when or if it will obtain regulatory approval to commercialize a product candidate or receive reasonable reimbursement; uncertainty inherent in clinical trials and the regulatory review process; risks and uncertainties associated with drug development and commercialization; the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations, and financial condition; factors that could cause actual results to differ materially from those described in the forward-looking statements are set forth under the heading “Risk Factors” in our most recent annual or quarterly report and in other reports we have filed with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent management’s plans, estimates, assumptions and beliefs only as of the date of this release. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

PR Contact:

Bryan Blatstein
Spectrum Science Communications
T: (212) 468-5379 or (917) 714-2609
[email protected]

Corporate Contact:

Stephen Potter
Chief Business Officer
Applied Genetic Technologies Corporation
T: (617) 413-2754
[email protected]

AGTC is Excited to Announce Seasoned Healthcare Financial and Operations Executive Jonathan I. Lieber as their new Chief Financial Officer

September 8, 2021 at 8:00 AM EDT

GAINESVILLE, Fla. and CAMBRIDGE, Mass., Sept. 08, 2021 (GLOBE NEWSWIRE) — 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 retinal diseases, today announced Jonathan I. Lieber as their new Chief Financial Officer.

“We are thrilled to welcome Jonathan Lieber to the AGTC team,” said Sue Washer, President and CEO of AGTC. “He’s a seasoned financial and operations executive with valuable experience in the healthcare sector, making him a great addition to the AGTC team. We are excited to see his strategic perspective and apply it to our operational planning.”

Mr. Lieber brings 30 years of experience as a both CFO for emerging growth public and private life sciences companies and an investment banker. In his role as a CFO, Mr. Lieber has led numerous capital raises and had responsibility for financial reporting and regulatory compliance. He has developed relationships with investors, and provided strategic counsel to C-suite executives and Boards of Directors to support strategic planning, business development, and investor relations activities.

“I’m excited to become a part of the exciting work that AGTC is doing in the gene therapy world,” said Mr. Lieber. “AGTC’s work is leading the way to meet an unmet medical need in the ophthalmology community, and I’m thrilled that I have the opportunity to help AGTC execute on its future plans.”

About AGTC

AGTC is a clinical-stage biotechnology company developing genetic therapies for people with rare and debilitating ophthalmic, otologic and central nervous system (CNS) diseases. AGTC is a leader in designing and constructing all critical gene therapy elements and bringing them together to develop customized therapies that address real patient needs. AGTC’s most advanced clinical programs leverage its best-in-class technology platform to potentially improve vision for patients with an inherited retinal disease. AGTC has active clinical trials in X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM CNGB3 and ACHM CNGA3). Its preclinical programs build on the Company’s industry leading AAV manufacturing technology and scientific expertise. AGTC is advancing multiple important pipeline candidates to address substantial unmet clinical need in optogenetics, otology and CNS disorders. In recent years AGTC has entered into strategic partnerships with companies including Otonomy, Inc., a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, and Bionic Sight, LLC, an innovator in the emerging field of optogenetics and retinal coding.

Forward-Looking Statements

This release contains forward-looking statements that reflect AGTC’s plans, estimates, assumptions and beliefs, including statements about the potential of the Company’s late-stage development programs in X-Linked Retinitis Pigmentosa (XLRP) and Achromatopsia (ACHM). Forward-looking statements include information concerning possible or assumed future results of operations, financial guidance, business strategies and operations, preclinical and clinical product development and regulatory progress, potential growth opportunities, potential market opportunities, the effects of competition and the impact of the COVID-19 pandemic, including the impact on its ability to obtain the raw materials necessary to conduct its clinical trials. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “seeks,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Actual results could differ materially from those discussed in the forward-looking statements, due to a number of important factors. Risks and uncertainties that may cause actual results to differ materially include, among others: gene therapy is still novel with only a few approved treatments so far; AGTC cannot predict when or if it will obtain regulatory approval to commercialize a product candidate or receive reasonable reimbursement; uncertainty inherent in clinical trials and the regulatory review process; risks and uncertainties associated with drug development and commercialization; the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations, and financial condition; factors that could cause actual results to differ materially from those described in the forward-looking statements are set forth under the heading “Risk Factors” in our most recent annual or quarterly report and in other reports we have filed with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent management’s plans, estimates, assumptions and beliefs only as of the date of this release. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

Corporate Contact:

Stephen Potter

Chief Business Officer

Applied Genetic Technologies Corporation

T: (617) 413-2754

[email protected]

Source: Applied Genetic Technologies Corporation

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