This presentation contains forward-looking statements that reflect Applied Genetic Technologies Corporation's ("AGTC" or the "Company") plans, estimates, assumptions and beliefs. Forward-looking statements include statements regarding AGTC's proposed Phase 2/3 trial design for XLRP and the proposed Phase 1/2 expansion trial for XLRP, including the effectiveness of AGTC's pre-selection methodology for pre-specifying loci, its anticipated timeline and potential to receive FDA approval to begin the XLRP pivotal trial, the timing for completing and 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, business strategies and operations, 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, AGTC assumes no obligation to update or revise these forward-looking statements publicly, whether as a result of new information, new events or otherwise.

  • Recent accomplishment and latest developments - Sue Washer, CEO

  • Clinical program update - Dr. Mark S. Shearman, CSO

  • Q2 2021 financial results review - Bill Sullivan, CFO

  • Q&A

  • Closing Remarks - Sue Washer

  • ACHM study is the first to report sensitivity improvement following treatment - January 2021 results support the previously presented positive patient-reported outcomes and provide a path forward to collect additional data to fully realize the potential of our ACHM therapies

  • Reported additional positive data from the Phase 1/2 XLRP clinical trial

    • - November 2020 data indicated durable improvements observed in visual sensitivity and visual acuity over a wide dose range with a favorable safety profile out to month 12 in two of the dose groups

    • - AGTC believes the Company has a best-in-class product that may provide significant benefit to patients with XLRP

  • Successfully completed a public offering of common stock and warrants, raising approximately $69 million in net proceeds

    - Current cash runway into calendar year 2023

This is an excerpt of the original content. To continue reading it, access the original document here.

Attachments

  • Original document
  • Permalink

Disclaimer

Applied Genetic Technologies Corp. published this content on 11 February 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 11 February 2021 13:42:08 UTC.