Earnings release
Page 1
FREQUENCY THERAPEUTICS Frequency Therapeutics Provides Business Updates and Third Quarter 2021 Financial Results Enrollment Underway for FX - 322-208 Phase 2b Study in Subjects with Sudden and Noise - Induced Sensorineural Hearing Loss ; Aligns with FDA on Speech Perception as Primary Endpoint for FX - 322 Studies Expands Pipeline with New Pre - Clinical Program for Hearing Restoration that May Provide Broader Cochlear Exposure and the Potential to Address Expanded SNHL Patient Populations Introduces Remyelination Program in Multiple Sclerosis ( MS ) , Sharing In Vivo Data Showing Substantially Greater Activity than Biologic or Small Molecule Comparators LEXINGTON , Mass . , Nov. 15 , 2021 – Frequency Therapeutics , Inc. ( Nasdaq : FREQ ) , a clinical - stage regenerative medicine company focused on developing therapeutics to activate a person's innate regenerative potential to restore function , today announced business updates and financial results for the third quarter ended September 30 , 2021 . " Frequency has made significant operational progress throughout this year , highlighted by the initiation of a Phase 2b study ( FX - 322-208 ) of FX - 322 , our lead program for sensorineural hearing loss ( SNHL ) . We have designed this study following careful analysis of multiple completed FX - 322 exploratory clinical studies , and through this work , we've increased our understanding of the specific patient etiologies and severities where hearing benefits were observed . We have also reached alignment with the U.S. Food and Drug Administration ( FDA ) on speech perception as the primary efficacy endpoint that we believe helps de - risk future development activities , ” said David L. Lucchino , Frequency's Chief Executive Officer . " At our recent R & D event , we detailed results from our completed FX - 322 clinical studies , showing all of the data demonstrating a clear signal of clinical benefit in a significant segment of individuals with SNHL . We also showed how the breadth of our clinical efforts informed the inclusion criteria of our ongoing FX - 322-208 Phase 2b study . Furthermore , we were excited to introduce two new research programs , the first a pre - clinical development candidate to treat SNHL that can reach deeper into the cochlea and which may provide the opportunity to treat different patient populations . The second is a novel candidate for remyelination in MS that has shown significant remyelinating effect in vivo and has the potential to provide a highly differentiated offering compared to currently approved MS treatments . " FX - 322 Clinical Study Overview and Recent Corporate Highlights FX - 322-208 Phase 2b Study in Acquired SNHL : In October , Frequency announced that the first subject was dosed in a new Phase 2b study of acquired SNHL . FX - 322-208 is a randomized , placebo - controlled , multi - center study designed to evaluate the impact of a single administration of FX - 322 on speech perception in approximately 124 subjects with SNHL .