Earnings release
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FREQUENCY = 1 THERAPEUTICS Exhibit 99.1 Frequency Therapeutics Provides Business Updates and Second Quarter 2021 Financial Results Company Plans to Commence New FX - 322 Phase 2 Study in Q4 2021 in a Refined Population of Individuals with Sensorineural Hearing Loss ( SNHL ) Will Host R & D Event on November 9th to Provide Detailed Insights into FX - 322 Clinical Data , Plans for Continued FX - 322 Development and New Pipeline Advancements for Hearing Loss and Multiple Sclerosis LEXINGTON , Mass . , Aug. 12 , 2021 - Frequency Therapeutics , Inc. ( Nasdaq : FREQ ) , a clinical - stage biotechnology company focused on harnessing the body's innate biology to repair or reverse damage caused by a broad range of degenerative diseases , today announced business updates and financial results for the second quarter ended June 30 , 2021 . " We have made important progress in our efforts to advance FX - 322 , our lead program for SNHL , toward its next step in clinical development . We are now completing a thorough analysis of our FX - 322 exploratory clincial studies , which has served to increase our understanding of the etiologies and severities where hearing benefits have been observed in study subjects . Based on the overall learnings from multiple completed studies , we plan to initiate a randomized and well- controlled Phase 2 trial in the fourth quarter of this year , using a single administration of FX - 322 in a refined population of subjects with SNHL . In addition , this trial will incorporate several novel study design elements that we believe will help address previously observed study bias , ” said David L. Lucchino , Frequency's Chief Executive Officer . “ In the fourth quarter , we also intend to share topline data from our FX - 322 Phase 1b learning study of subjects with severe SNHL ( FX- 322-113 ) . Our plan is to maintain flexibility in the design of the new Phase 2 trial so we may also incorporate insights from the study of severe SNHL subjects . " " This November , we will host an R & D event for investors where we will detail findings from all of our FX - 322 clinical studies . These insights have provided the basis for our enthusiasm in the program and have informed the design of our upcoming Phase 2 clinical trial . In addition , we plan to discuss other potential near- term and longer - term areas of pipeline expansion , including continued advancements in hair cell regeneration , as well as the progress we have made in our preclinical program for remyelination in multiple sclerosis ( MS ) , our scientific approach toward compound selection and the in vivo data that we believe supports our MS program , " Mr. Lucchino concluded . Clinical Study Overview and Recent Corporate Highlights Sensorineural hearing loss is the most common form of hearing loss , typically resulting from damage to auditory sensory hair cells in the inner ear . These cells convert sound waves to signals sent to the brain . Sensory hair cells may be lost due to noise exposure , aging , certain viral infections or exposure to drugs that are toxic to the ear .