Frequency Therapeutics, Inc. announced clinical results from the placebo-controlled Phase 2b study of FX-322 in individuals with acquired Sensorineural Hearing Loss (SNHL). The study, which enrolled 142 people with either sudden or noise-induced sensorineural hearing loss, failed to achieve its primary efficacy endpoint of an improvement in speech perception. Data showed no statistically meaningful difference at day 90 between those administered FX-322 versus those receiving placebo in the proportion of individuals that demonstrated an improvement in speech perception.

There were also no measurable improvements observed in any of the study's secondary endpoints. Prior FX-322 studies had been designed to best understand patient etiologies and severities where a hearing signal could be observed. FX-322-208 was statistically powered with a balanced placebo and active group.

The safety profile associated with FX-322 was favorable and no study participants experienced a serious adverse event that was associated with treatment. The Company will now discontinue the FX-322 development program. In addition, while dosing of FX-345, asecond program to treat SNHL, has been completed in the initial safety cohort of an ongoing Phase 1b trial, that development program will also be discontinued.

The Company will now focus its resources to advance its remyelination in MS program into the clinic. Frequency's efforts now will focus on continuing to develop novel therapeutics to induce remyelination for individuals living with MS. The Company previously reported that it had identified a novel target relevant to myelination. Modulation of this target drives robust oligodendrocyte differentiation and expression of myelin proteins in vitro.

The Company has identified multiple novel chemical entities that induce robust remyelination following demyelination in an adult in vivo animal model. The MS program is independent of the hearing program, with a distinct molecular target, mechanism, progenitor cell population, and small molecule drug candidates. Further, a well-defined clinical path with objective biomarkers such as visual evoked potential (VEP) and magnetic resonance imaging (MRI) exist for studying the performance of remyelination therapies in MS patients.

Frequency's agents substantially outperform other clinically studied remyelination agents in head-to-head in vivo studies. Frequency plans to begin its clinical program for remyelination in 1H 2024. The Company will immediately reduce headcount as part of an overall restructuring, downsizing personnel by approximately 55 percent.

The Company believes that the restructuring will generate sufficient cost savings to extend its runway into 2025 and enable it to completeafirst clinical trial of its MS program in 2H 2024. As of December 31, 2022, Frequency had cash, cash equivalents and marketable securities of $83.1 million (excluding restricted cash).