AGTC names two leaders
About Eyes
Applied Genetic Technologies Corporation (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), recently announced the appointment of Susan Schneider, M.D., as Chief Medical Officer (CMO) and Sarah C. DiSalvatore, M.P.H., as Vice President of Clinical Operations.
“We are excited to welcome Dr. Susan Schneider and Ms. Sarah DiSalvatore to AGTC during a pivotal time in our company’s history as we advance our X-Linked Retinitis Pigmentosa program into late-stage clinical development and prepare the End-of-Phase 2 submission for our Achromatopsia B3 program,” said Sue Washer, president and chief executive officer of AGTC. “Dr. Schneider’s wealth of ophthalmology experience and impressive accomplishments bring valuable expertise to AGTC’s leadership team. We believe our XLRP and Achromatopsia B3 programs have best-in-class data, and Susan’s perspective will help drive forward and optimize our development of gene therapies in inherited diseases as our clinical trials continue to progress.”
According to Washer, Dr. Schneider is a biopharmaceutical leader with a proven track record of delivering high quality clinical development results, globally, across the eyecare industry. An ophthalmologist by training, her expertise in developing high performing ophthalmic therapeutic teams and building strong cross-functional programs will further strengthen AGTC’s leadership in advancing their clinical stage assets.
Prior to joining AGTC, Dr. Schneider served in various positions in clinical and medical affairs, most recently as senior vice president, clinical development, ophthalmology at Ji Xing Pharmaceuticals, where she was responsible for project leadership, growth and development of ophthalmology programs and for providing clinical input on business development interests. Previous roles include serving as senior vice president, clinical development, ophthalmology at Eloxx Pharmaceuticals, chief marketing officer at Oxurion (formerly ThromboGenics) and vice president and therapeutic area head of glaucoma and retina at Allergan. She began her corporate career in clinical development at Genentech where she worked extensively on the ranibizumab program, leading to the approval and launch of LUCENTIS.
Dr. Schneider completed her residency in ophthalmology at the Medical College of Virginia followed by fellowships in ocular oncology at Thomas Jefferson Wills Eye Hospital and in ophthalmic pathology at The Johns Hopkins Wilmer Eye Institute. She will join AGTC on November 8, 2021.
“I’m thrilled to bring my passion and expertise in ocular diseases to AGTC as the company progresses its gene therapy clinical trials,” said Dr. Schneider. “AGTC is a leader in the field and working to meet important unmet medical needs in the ophthalmology community. I look forward to partnering with the team to push forward groundbreaking research and treatments.”
Additionally, AGTC named Sarah C. DiSalvatore, M.P.H., as vice president of clinical operations. DiSalvatore has extensive experience in strategic leadership, having served most recently as associate vice president of clinical operations for Rocket Pharma, where she was responsible for multiple rare disease and gene therapy programs in the U.S. and Europe. Prior to Rocket Pharma, she held senior leadership positions at Stemline Therapeutics and Nucana and has contributed to the FDA approval of several products. She is an accomplished pharmaceutical professional who brings deep experience in research and development to our clinical operations team, ranging from laboratory bench work to Investigational New Drug preparations and New Drug Applications/ Biologics License Applications filings. DiSalvatore will join AGTC on November 1, 2021.
Applied Genetic Technologies Corporation, a publicly traded clinical-stage biotechnology company that is part of the NASDAQ Biotechnology Index, was founded in 1999 and has its headquarters in Alachua, Florida. AGTC focuses on ophthalmologic genetic diseases. AGTC develops genetic therapies for people with rare and debilitating ophthalmic, otologic and central nervous system (CNS) diseases. It designs and constructs critical gene therapy elements and brings them together to develop customized therapies with the potential to address 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 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 and has entered into strategic collaborations 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.
In 2020 the company reported positive results from a Phase 1/2 trial for its investigational gene therapy for retinitis pigmentosa. A few weeks later, the company reported interim six-month data from the dose-escalation cohorts of its ongoing Phase 1/2 clinical programs in patients with achromatopsia due to mutation in the ACHM CNGB3 or ACHM CNGA3 genes. Applied Genetic Technologies Corporation is a patient partner within the blinding eye disease and rare disease community, including organizations like Foundation for Fighting Blindness and Global Genes.
In addition to its clinical trials, AGTC has preclinical programs in optogenetics, other ophthalmology, central nervous system and otology indications. In addition to its product pipeline, AGTC has a significant intellectual property portfolio and extensive expertise in the design of gene therapy products including capsids, promoters and expression cassettes, as well as expertise in the formulation, manufacture and physical delivery of gene therapy products.
In 2021, AGTC's revenue was $500,000, a decrease of -79.62 percent, compared to the previous year's $2.45 million. Losses were -$57.83 million, 26.0 percent more than in 2020. Still, according to eight analysts, the average rating for AGTC stock is a "Strong Buy." The 12-month stock price forecast is 15.67, which is an increase of 493.56% from the latest price. Some analysts think that AGTC is good value based on its book value relative to its share price (1.33 times), compared to the US Biotechnology industry average (6.53 times). AGTC's cash and short-term investments ($107.05 million) can cover AGTC's cash burn for the next year ($52.63 million), even accounting for increasing cash burn (83.69 percent).