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Frequency Therapeutics, Inc. (Nasdaq: FREQ) has announced updates and financial results for Q4 and the full year 2022. The company reported a cash position of $83.1 million as of December 31, 2022, which is expected to fund operations into Q1 2025. CEO David L. Lucchino confirmed plans to initiate a clinical trial for a remyelination therapy targeting multiple sclerosis in H1 2024. However, the FX-322-208 study for hearing restoration failed its primary endpoint, leading to the discontinuation of related programs. R&D expenses decreased to $10.6 million in Q4 2022, while the net loss was $17.4 million, down from $21.5 million in Q4 2021.
Frequency Therapeutics, Inc. (NASDAQ: FREQ) announced that interim CEO Christopher Loose, Ph.D., will present at two major healthcare investor conferences in March. He will participate in a panel at the 43rd Annual Cowen Healthcare Conference on March 8 at 12:50 p.m. ET and provide a company overview at the 33rd Annual Oppenheimer Healthcare Conference on March 13 at 8:00 a.m. ET. Live webcasts of these events will be available on the company’s website, with replays posted afterward. Frequency Therapeutics focuses on regenerative medicine aimed at restoring human function through the activation of progenitor cells, particularly targeting potential therapies for multiple sclerosis.
Frequency Therapeutics announced that the Phase 2b clinical study of FX-322 in treating acquired sensorineural hearing loss did not meet its primary endpoint, showing no significant improvement in speech perception compared to placebo. No measurable improvements were noted in secondary endpoints either. As a result, the company will discontinue FX-322 and FX-345 development programs and will focus on advancing its remyelination program for multiple sclerosis (MS). The company plans a corporate restructuring, reducing its workforce by approximately 55%, to generate cost savings to support its MS program, targeting a clinical trial in 2H 2024.
Frequency Therapeutics (NASDAQ: FREQ) announced key advancements in its remyelination program for multiple sclerosis (MS), planning a regulatory filing in 2023. A Clinical Advisory Board has been established, featuring prominent neurology experts to aid in clinical development. The company also expanded its Regenerative Medicine Advisory Board with Nobel Laureate Dr. James Rothman, enhancing its scientific expertise. The initiative aims to address neurodegeneration in MS, which remains a significant unmet medical need.
Frequency Therapeutics announced the dosing of the first patient in the Phase 1b study of FX-345, its second therapy for sensorineural hearing loss (SNHL). This study aims to evaluate the safety of FX-345, featuring a more potent GSK3 inhibitor to enhance drug exposure in the cochlea. Results are expected in H2 2023. Additionally, the ongoing Phase 2b trial of FX-322 is fully enrolled, with results anticipated in Q1 2023. Frequency targets to advance regenerative treatments for SNHL, impacting around 40 million people in the U.S.
Frequency Therapeutics (Nasdaq: FREQ) announced a virtual investor event on December 13, 2022, to discuss its lead candidate, FX-322, for treating acquired sensorineural hearing loss. The fully enrolled Phase 2b study (FX-322-208) aims to evaluate speech perception enhancements, with results expected in Q1 2023. Key opinion leaders will provide insights on potential market opportunities and the drug's integration with hearing devices. FX-322 has shown promise in previous studies, demonstrating a favorable safety profile with no severe adverse events reported.
Frequency Therapeutics reported business updates and financial results for Q3 2022, highlighting significant progress in its clinical studies. Enrollment for the Phase 2b study of FX-322 for sensorineural hearing loss is complete, with data readout expected in Q1 2023. The company anticipates a Phase 1b trial for its second candidate, FX-345, soon. Financially, it holds $99.3 million in cash, projected to fund operations into 2024. However, there was no revenue recorded for Q3 2022 due to a previous upfront payment recognition.