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Frequency Therapeutics, Inc. (Nasdaq: FREQ) has initiated its Phase 2b study (FX-322-208) for sensorineural hearing loss (SNHL) and reached an FDA agreement on speech perception as the primary efficacy endpoint. The company introduced FX-345, a new candidate for SNHL, and a remyelination program for multiple sclerosis (MS) showcasing promising in vivo results. Financially, cash reserves are at $160.5 million, with a net loss of $25.2 million for Q3 2021, marking a significant increase from 2020. Revenue dropped to $14.1 million for the first nine months of 2021.
Frequency Therapeutics (FREQ) is hosting a virtual R&D event to discuss completed clinical data for FX-322 in patients with sensorineural hearing loss (SNHL). The company highlights significant clinical improvements in speech perception and FDA alignment on this as a primary efficacy endpoint. Additionally, it introduces FX-345 for a broader cochlear approach to SNHL treatment and discusses promising remyelinating agents for multiple sclerosis (MS). The event features insights from key executives and experts, underscoring the potential of their regenerative therapies.
Frequency Therapeutics will host a virtual R&D event on November 9, 2021, focusing on FX-322 clinical study results for sensorineural hearing loss (SNHL) and the new FX-322-208 Phase 2b study. Key findings from nearly 170 subjects will be reviewed, highlighting potential patient populations likely to benefit from FX-322. The FDA has agreed to use speech perception as the primary endpoint. Additionally, the company will introduce a second hearing restoration program and a remyelinating agent for multiple sclerosis, showcasing advancements in regenerative medicine.
Frequency Therapeutics has initiated its FX-322-208 Phase 2b clinical study, focusing on acquired sensorineural hearing loss (SNHL). The randomized, placebo-controlled study will assess speech perception improvements in 124 subjects. The FDA validated speech perception as a primary endpoint in a recent meeting. Previous studies showed significant efficacy, with FX-322 demonstrating safety across 175 patients. An R&D event is scheduled for
Frequency Therapeutics (NASDAQ: FREQ) announced positive results from its FX-322-111 study, where four additional subjects with sensorineural hearing loss showed statistically significant improvements in speech perception up to 12 months after treatment. This brings the total to nine subjects showing significant improvements, suggesting prolonged benefits from a single dose of FX-322. The study aims to further evaluate long-term effects and refine trial designs. Frequency plans to initiate a new Phase 2 trial soon, focusing on the treatment of hearing loss.
Frequency Therapeutics, Inc. (NASDAQ: FREQ) announced that CEO David L. Lucchino will present at two upcoming investor conferences. The H.C. Wainwright 23rd Annual Global Investment Conference will be available for on-demand viewing from September 13, 2021, at 7:00 a.m. ET. Additionally, the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit is scheduled for September 22, 2021, at 8:15 a.m. ET. The presentations can be accessed via the investors section of Frequency's website, where replays will also be available.
Frequency Therapeutics (Nasdaq: FREQ) reported significant updates for Q2 2021, including progress on FX-322, their treatment for sensorineural hearing loss (SNHL). They plan to initiate a Phase 2 trial in Q4, guided by insights from previous studies. Financially, the company reported revenues of $9.4 million, lower than the previous year's $14.1 million. Research and development expenses increased significantly to $17.4 million. Net loss widened to $17.7 million, up from $6.0 million in Q2 2020, primarily due to rising R&D and administrative costs.
Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage biotechnology firm, has announced that CEO David L. Lucchino will present at two upcoming investor conferences. The presentations are scheduled for the Jefferies Virtual Healthcare Conference on June 2, 2021, at 2:30 p.m. EDT, and the Goldman Sachs 42nd Annual Global Healthcare Conference on June 10, 2021, at 8:00 a.m. EDT. Live webcasts can be accessed on the investors section of Frequency's website, with replays available post-event.
Frequency focuses on developing therapies that activate progenitor cells to treat degenerative diseases, including FX-322 for hearing restoration.
Frequency Therapeutics, Inc. (Nasdaq: FREQ) supports the Hearing Loss Association of America (HLAA) in its groundbreaking Externally-Led Patient-Focused Drug Development (EL-PFDD) meeting focused on sensorineural hearing loss (SNHL). This initiative aims to provide the FDA with insights from patients affected by SNHL, a common hearing loss form impacting millions globally. Frequency Therapeutics is advancing treatments for hearing restoration, particularly through its lead candidate FX-322, aimed at regenerating auditory hair cells. The meeting is scheduled for May 25, 2021.
Frequency Therapeutics (Nasdaq: FREQ) reported its financial results for Q1 2021, revealing revenue of $4.7 million compared to $7.3 million in Q1 2020. The company experienced a net loss of $20.4 million, significantly up from $4.9 million year-over-year. Research and development expenses soared to $15.1 million, driven by costs linked to FX-322 trials. Despite challenges, including non-significant treatment effects in a recent study, Frequency continues refining its clinical approach for hearing loss treatments, with sufficient cash reserves expected to last into 2023.