This presentation contains forward-looking statements that reflect AGTC's plans, estimates, assumptions and beliefs. Forward-looking statements include statements regarding its proposed Phase 2/3 trial design for XLRP, its anticipated timeline and potential to receive FDA approval to begin the XLRP pivotal trial, the timing for reporting data in its XLRP and ACHM clinical programs, its ability to enroll patients for its clinical trials, the expected costs of its clinical programs and its planned manufacturing activities, regulatory progress, potential growth and market opportunities, and the effects of competition. 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: AGTC cannot predict when or if it will obtain regulatory approval to continue to progress its clinical trials, 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; risks related to the COVID-19 outbreak that may delay clinical trial enrollment; gene therapy is still novel with only a few approved treatments so far; 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 the Company's 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 presentation. 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.
Science
Differentiated With
Demonstrated
Capabilities
Superior pre-clinical data
Robust use of disease- specific animal modeling
Manufacturing XLRP
Unmatched | Best-in-Class |
Productivity, | Late-Stage |
Scalability & Quality | Asset |
10-fold reduction in | Improvements in visual |
process residuals and | function sustained for at |
10-fold increase in | least six months |
productivity | No SAEs across |
At commercial scale: 40 L | 100-fold dose range |
≥ 2000 ophthalmic doses |
Diversified
Pipeline
High-Value
Programs
Diversified across
ophthalmology,
neurodegenerative and
otology indications
Foundational data
supports development of next-gen technology concepts
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Applied Genetic Technologies Corp. published this content on 23 December 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 23 December 2020 21:34:03 UTC