FREQ Frequency Therapeutics Inc.

47.2
-0.8  -2%
Previous Close 48
Open 48.66
52 Week Low 14.5
52 Week High 58.37
Market Cap $1,592,277,462
Shares 33,734,692
Float 30,636,476
Enterprise Value $1,438,094,193
Volume 238,360
Av. Daily Volume 311,726
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Drug Stage Catalyst Date
FX-322
Acquired Sensorineural Hearing Loss (SNHL)
Phase 2a
Phase 2a
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FX-322
Age-Related Hearing Loss
Phase 1b
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FX-322
Severe Sensorineural Hearing Loss (SNHL)
Phase 1b
Phase 1b
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Latest News

  1. Results Published in Leading Peer-Reviewed Otolaryngology Journal, Otology & Neurotology

    Statistically Significant Improvements Observed in Word Recognition Tests in Quiet and in Noise; Suggests Potential to Improve Speech Intelligibility, a Major Unmet Need for Individuals with Hearing Loss

    Company Expects Interim FX-322 Phase 2a Study Data Later this Quarter

    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 the publication of its FX-322 Phase 1/2 study results in Otology & Neurotology, a leading peer-reviewed journal focused on disorders of the ear. The data show…

    Results Published in Leading Peer-Reviewed Otolaryngology Journal, Otology & Neurotology

    Statistically Significant Improvements Observed in Word Recognition Tests in Quiet and in Noise; Suggests Potential to Improve Speech Intelligibility, a Major Unmet Need for Individuals with Hearing Loss

    Company Expects Interim FX-322 Phase 2a Study Data Later this Quarter

    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 the publication of its FX-322 Phase 1/2 study results in Otology & Neurotology, a leading peer-reviewed journal focused on disorders of the ear. The data show hearing improvements in adults with acquired sensorineural hearing loss (SNHL) and the first-known linkage of pharmacokinetics and pharmacodynamics for a potential hearing restoration therapy.

    Findings from the Phase 1/2 study of FX-322, the company's lead product candidate to treat SNHL, showed statistically significant increases in word recognition (WR) and words-in-noise (WIN) scores. Individuals with stable SNHL that received a single dose of FX-322 showed improvements in the number of words recognized in quiet from baseline to day 90 in the WR test (p=0.029) and the level of background noise in which words could be identified in the WIN test (p=0.012). There were no meaningful changes in the WR and WIN scores of the placebo group. FX-322 was also shown to be well tolerated. The publication includes data demonstrating consistent cochlear drug delivery in both preclinical and human studies. FX-322 is currently being evaluated in a larger Phase 2a study, with results anticipated later this quarter.

    The study data will be presented today at the leading international hearing research conference, the Association for Research in Otolaryngology 44th Annual MidWinter Meeting.

    "Healthy hearing is not just about the volume of sound, but about the broader ability to communicate. The most frequent complaint from patients with hearing loss is their inability to understand speech, which is due to a lack of clarity and loss of intelligibility where patients can't recognize words and follow conversations, particularly in background noise," said Christina Runge, Ph.D., a professor in the Department of Otolaryngology and Communication Sciences at the Medical College of Wisconsin, Director of the Koss Cochlear Implant Program, a member of the Company's clinical advisory board and an author on the publication. "These Phase 1/2 data are the first to show a potential therapeutic solution to address intelligibility, a key unmet need for those with SNHL."

    SNHL accounts for more than 90 percent of all hearing loss and results from damage to auditory sensory hair cells due to chronic noise exposure, aging, certain viral infections or from toxic medications. SNHL impacts more than 40 million people in the U.S. and hundreds of millions of people globally.

    "Having a treatment that regenerates sensory hair cells would have a profound impact on the field, providing physicians with a meaningful intervention for restoring hearing loss," said Ravi N. Samy, M.D., FACS, Professor of Otolaryngology & Neurosurgery and Chief of the Division of Otology/Neurotology at the University of Cincinnati / Cincinnati Children's. "These exciting early clinical data begin to show the potential of a localized approach to repairing the cochlea, the ability to deliver a treatment to an area of the body that historically has been impossible to access and restore, and above all, clinically meaningful hearing improvements in patients."

    Hearing loss typically begins in higher frequencies and often impacts the ability to hear and distinguish between certain consonants, making it difficult to understand words, especially in noise. Hearing aids amplify sound but do not improve hearing clarity in higher frequencies or repair the underlying damage to the inner ear. FX-322, an injectable treatment candidate made up of two small molecules, is designed to activate progenitor cells (pre-programmed stem cells) to regenerate auditory hair cells in the cochlea and restore hearing function.

    "These Phase 1/2 study data build upon the favorable word recognition performances that we previously reported, while bolstering the trends we saw in words-in-noise scores," said Will McLean, Ph.D., Frequency's Vice President of Biology and Regenerative Medicine, a Company co-founder and the lead author on the paper. "Increases in speech intelligibility and improvements when listening in noisy environments can have a significant impact on quality of life, and we are excited about the potential of our approach for patients and to advance the field of hearing restoration."

    FX-322 Development Program

    FX-322 is Frequency's lead product candidate for the treatment of acquired SNHL. The Phase 1/2 study was a randomized, double-blind, placebo-controlled, single-dose, multi-center study to assess the safety of FX-322 in 23 patients with stable SNHL. Patients received an intratympanic injection of FX-322 or placebo in one ear during an office-based procedure. In the study, 15 patients received a single dose of FX-322 in one ear while eight patients received placebo.

    Of the six patients treated with FX-322 who had baseline word recognition in quiet scores of below 90 percent, four showed clinically meaningful improvements. Also, when assessed at the group level, patients treated with FX-322 outperformed the placebo group in word recognition in a quiet background when averaged across all time points.

    The FX-322 Phase 2a study is a randomized, double-blind, placebo-controlled, single- and repeat-dose study in which the Company enrolled 95 patients aged 18 to 65 with mild to moderately severe SNHL. The study uses validated measures of hearing function including WR, WIN and pure tone audiometry.

    Tinnitus and quality-of-life measures will be evaluated using the Tinnitus Functional Index and the Hearing Handicap Inventory for Adults, respectively, and the study also includes testing of extended high frequencies (up to 16 kHz). The Phase 2a study has four dose cohorts, and hearing function will be regularly tested over the course of seven months following the first dosing.

    The Company is conducting Phase 1b clinical studies to evaluate the potential of FX-322 in additional patient groups, including patients with age-related hearing loss and with severe SNHL. The Company is also conducting an open-label safety study looking at the administration conditions for FX-322.

    A link to the publication, Improved Speech Intelligibility in Subjects with Stable Sensorineural Hearing Loss Following Intratympanic Dosing of FX-322 in a Phase 1b Study (W.J. McLean, et. al.) can be found here. The Editor-in-Chief of Otology and Neurotology is Lawrence Lustig, M.D., Chair, Department of Otolaryngology - Head & Neck Surgery at Columbia University.

    About Frequency Therapeutics

    Frequency Therapeutics is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The Company's progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue with the aim of developing disease modifying therapies. The Company's lead product candidate, FX-322, is designed to regenerate auditory hair cells to restore hearing function. FX-322 is being evaluated in multiple ongoing clinical studies in patients with sensorineural hearing loss. The Company also is evaluating additional diseases where its PCA approach could create functional tissue, including in a pre-clinical program in multiple sclerosis.

    Headquartered in Woburn, Mass., Frequency has an ex-U.S. license and collaboration agreement with Astellas Pharma Inc. for FX-322, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including Massachusetts Eye and Ear, Mass General Brigham, the Massachusetts Institute of Technology, The Scripps Research Institute and Cambridge Enterprises Limited. For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the Phase 2a clinical trial, the timing of top-line data from the Phase 2a clinical trial, the timing and results of top-line data from the Phase 1b studies in age-related hearing loss and severe SNHL, the implications of the results of the Phase 1/2 data, the timing and results of the open-label safety study evaluating the administration conditions for FX-322, the ability of our technology platform to provide patient benefit, estimates of the size of the hearing loss population and population at risk for hearing loss, the Company's ability to advance its hearing program and further diversify its portfolio and the potential application of the PCA platform to other diseases.

    These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of COVID-19 on the Company's ongoing and planned clinical trials, research and development and manufacturing activities, the relocation of the Company's offices and laboratory facilities, the Company's business and financial markets; the Company has incurred and will continue to incur significant losses and is not and may never be profitable; the Company's need for additional funding to complete development and commercialization of any product candidate; the Company's dependence on the development of FX-322; the unproven approach of the PCA platform; the lengthy, expensive and uncertain process of clinical drug development and regulatory approval; limited experience successfully obtaining marketing approval for and commercializing product candidates; the results of earlier clinical trials not being indicative of the results from later clinical trials; differences between preliminary or interim data and final data; adverse events or undesirable side effects; disruptions at the FDA and other regulatory agencies; failure to identify additional product candidates; new or changed legislation; failure to maintain Fast Track designation for FX-322 and such designation failing to result in faster development or regulatory review or approval; costly and damaging litigation, including related to product liability or intellectual property or brought by stockholders; dependence on Astellas Pharma Inc. for the development and commercialization of FX-322 outside of the United States; misconduct by employees or independent contractors; reliance on third parties, including to conduct clinical trials and manufacture product candidates; compliance with laws and regulations, including healthcare and environmental, health, and safety laws and regulations; failure to obtain, maintain and enforce protection of patents and other intellectual property; security breaches or failure to protect private personal information; attracting and retaining key personnel; and ability to manage growth.

    These and other important factors discussed under the caption "Risk factors" in the Company's Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 16, 2020 and its other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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  2. Dr. Franck joins from Massachusetts Eye and Ear, where he was Director of Audiology and Harvard Medical School Faculty in the Department of Otolaryngology-Head and Neck Surgery

    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 the appointment of Kevin Franck, Ph.D., as Senior Vice President of Strategic Marketing and New Product Planning. Dr. Franck will lead pre-commercial strategy and launch planning for Frequency's clinical pipeline, including its lead program aimed at developing a restorative treatment for sensorineural hearing loss (SNHL), the most common form of…

    Dr. Franck joins from Massachusetts Eye and Ear, where he was Director of Audiology and Harvard Medical School Faculty in the Department of Otolaryngology-Head and Neck Surgery

    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 the appointment of Kevin Franck, Ph.D., as Senior Vice President of Strategic Marketing and New Product Planning. Dr. Franck will lead pre-commercial strategy and launch planning for Frequency's clinical pipeline, including its lead program aimed at developing a restorative treatment for sensorineural hearing loss (SNHL), the most common form of hearing loss.

    Dr. Franck is a leader in the hearing field with 25 years of experience including the development and commercialization of medical devices for people with hearing loss. A licensed audiologist, Dr. Franck joins Frequency from Massachusetts Eye and Ear, where he served as Director of Audiology and Harvard Medical School Faculty of the Department of Otolaryngology-Head and Neck Surgery. Prior to Mass Eye and Ear, he was Head of Marketing for Bose Hear, a division of Bose Corporation, where he led new product management and channel marketing of an emerging category of business focused on hearing loss. Dr. Franck co-founded Ear Machine, a startup funded by the National Institutes of Health before it was acquired by Bose in 2014. He has held senior roles at Cochlear Ltd., Artisan Healthcare Consulting and BiOM and worked as a clinician at the University of Michigan and the Children's Hospital of Philadelphia.

    "We are thrilled to have Kevin join Frequency. He has dedicated his career to improving the lives of those with hearing loss by advancing innovative technologies to market, through his work in research, commercial marketing, advocacy and as a clinician," said David Lucchino, Frequency's President and Chief Executive Officer. "Our objective is to help hundreds of millions of people globally with sensorineural hearing loss to more clearly hear speech and sound and to better communicate. Kevin's leadership will be critical as we advance our lead candidate FX-322 in pivotal clinical trials and prepare for potential commercialization in the US, and with our partner Astellas in the rest of the world."

    Dr. Franck holds an MBA in Healthcare Management from the Wharton School of the University of Pennsylvania, a Ph.D. in hearing science from the University of Washington, an MSE in biomedical engineering from Johns Hopkins University and a B.A. in engineering from Dartmouth College. He is the incoming Board Chair of the Hearing Loss Association of America.

    "I'm excited to join Frequency at this important time and contribute to advancing the field toward hearing regeneration," said Dr. Franck. "Currently available hearing devices have been an incomplete solution and many patients continue to struggle to understand speech and with sound clarity. Repairing the underlying damage that is the primary cause of acquired hearing loss has always been the ultimate objective, and Frequency may be on the cusp of addressing this ambitious goal."

    Frequency's lead product candidate FX-322 is designed to treat the underlying cause of SNHL by regenerating sensory hair cells through activation of progenitor cells already present in the cochlea. Sensory hair cells are responsible for amplifying, filtering, tuning and converting sounds, enabling people to clearly understand sounds and speech. The Company plans to share interim day-90 group-level data from its Phase 2a study of FX-322 late in Q1 2021, and is planning an end-of-study data read-out in late Q2 2021.

    About Frequency Therapeutics

    Frequency Therapeutics is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The Company's progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue with the aim of developing disease modifying therapies. The Company's lead product candidate, FX-322, is designed to regenerate auditory hair cells to restore hearing function. In a FX-322 Phase 1/2 study, statistically significant and clinically meaningful improvements in key measures of hearing function in patients with sensorineural hearing loss were observed. FX-322 is being evaluated in multiple ongoing clinical studies in patients with sensorineural hearing loss. The Company also is evaluating additional diseases where its PCA approach could create functional tissue, including in a pre-clinical program in multiple sclerosis.

    Headquartered in Woburn, Mass., Frequency has an ex-U.S. license and collaboration agreement with Astellas Pharma Inc. for FX-322, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including Massachusetts Eye and Ear, Mass General Brigham and the Massachusetts Institute of Technology, The Scripps Research Institute and Cambridge Enterprises Limited, Cambridge University, UK. . For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

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  3. 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 the appointment of Quentin McCubbin, Ph.D., as chief manufacturing officer. Dr. McCubbin will oversee Company technical operations, leading drug product formulation, chemistry manufacturing and controls (CMC) and supply chain, to support the development of Frequency's pipeline of product candidates.

    Dr. McCubbin joins Frequency from Cerevel Therapeutics, a clinical-stage biotechnology company where he served as head of technical operations. Prior to Cerevel, he spent 19 years at Takeda/Millennium Pharmaceuticals in various…

    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 the appointment of Quentin McCubbin, Ph.D., as chief manufacturing officer. Dr. McCubbin will oversee Company technical operations, leading drug product formulation, chemistry manufacturing and controls (CMC) and supply chain, to support the development of Frequency's pipeline of product candidates.

    Dr. McCubbin joins Frequency from Cerevel Therapeutics, a clinical-stage biotechnology company where he served as head of technical operations. Prior to Cerevel, he spent 19 years at Takeda/Millennium Pharmaceuticals in various roles progressing in responsibility, including six years as vice president of pharmaceutical sciences and global head of process chemistry.

    "Quentin's background and leadership in technical operations will be critical as we prepare for larger studies in support of our lead FX-322 program that aims to treat the most common form of hearing loss, and as we look to diversify and expand our clinical pipeline with a program for remyelination in multiple sclerosis," said David Lucchino, Frequency's President and Chief Executive Officer. "I am excited to have Quentin join our leadership team and believe his operational and technical expertise will play an essential role as we look to advance and commercialize a medicine for the tens of millions of patients in the U.S. with sensorienural hearing loss, and aim to leverage the broad potential of our progenitor cell activation platform."

    Frequency's lead product candidate FX-322 is designed to treat the underlying cause of sensorineural hearing loss (SNHL) by regenerating sensory hair cells by activating progenitor cells already present in the cochlea. Sensory hair cells are responsible for filtering, tuning and converting sounds, enabling people to clearly understand sounds and speech. The Company plans to share interim day-90 group-level data from its Phase 2a study of FX-322 late in Q1 2021, and is planning an end-of-study data read-out in late Q2 2021.

    Dr. McCubbin began his career as a chemist, completing a post-doctoral fellowship at Imperial College in London. He earned his B.S. and Ph.D. in chemistry from Monash University in Australia. He is an inventor on several patents and has published numerous peer-reviewed articles.

    "I'm excited to join Frequency at this critical point in the Company's evolution and to have an opportunity to play a role in advancing potential novel treatments for such profoundly vexing medical conditions," said Dr. McCubbin. "Frequency's platform and small molecule approach provides a unique opportunity to pursue a broad range of degenerative diseases and I'm thrilled to be a part of something with the potential to improve quality of life for so many."

    About Frequency Therapeutics

    Frequency Therapeutics is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The Company's progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue with the aim of developing disease modifying therapies. The Company's lead product candidate, FX-322, is designed to regenerate auditory hair cells to restore hearing function. In a FX-322 Phase 1/2 study, statistically significant and clinically meaningful improvements in key measures of hearing function in patients with sensorineural hearing loss were observed. FX-322 is being evaluated in multiple ongoing clinical studies in patients with sensorineural hearing loss. The Company also is evaluating additional diseases where its PCA approach could create functional tissue, including in a pre-clinical program in multiple sclerosis.

    Headquartered in Woburn, Mass., Frequency has an ex-U.S. license and collaboration agreement with Astellas Pharma Inc. for FX-322, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including The Scripps Research Institute, Massachusetts Eye and Ear, Cambridge Enterprises Limited, Mass General Brigham and the Massachusetts Institute of Technology. For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

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  4.  Company to Review FX-322 Clinical Development Program, Progress and Upcoming Milestones for the First Potential Medicine to Treat Sensorineural Hearing Loss

    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 that Chief Executive Officer David L. Lucchino will present a Company overview at the 39th annual J.P. Morgan Healthcare conference.

    Mr. Lucchino's presentation will take place on Wednesday, January 13th at 7:30 a.m. ET. The presentation will be followed by a question and answer session to be held at 8:00 a.m. ET. A live webcast of both the presentation and the breakout…

     Company to Review FX-322 Clinical Development Program, Progress and Upcoming Milestones for the First Potential Medicine to Treat Sensorineural Hearing Loss

    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 that Chief Executive Officer David L. Lucchino will present a Company overview at the 39th annual J.P. Morgan Healthcare conference.

    Mr. Lucchino's presentation will take place on Wednesday, January 13th at 7:30 a.m. ET. The presentation will be followed by a question and answer session to be held at 8:00 a.m. ET. A live webcast of both the presentation and the breakout session can be accessed on the investors section of Frequency's website, investors.frequencytx.com. A replay of the presentation will be posted on the Frequency website following the event.

    About Frequency Therapeutics

    Frequency Therapeutics is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The Company's progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue with the aim of developing disease modifying therapies. The Company's lead product candidate, FX-322, is designed to regenerate auditory hair cells to restore hearing function. In a FX-322 Phase 1/2 study, statistically significant and clinically meaningful improvements in key measures of hearing function in patients with sensorineural hearing loss were observed. FX-322 is being evaluated in multiple ongoing clinical studies in patients with sensorineural hearing loss. The Company also is evaluating additional diseases where its PCA approach could create functional tissue, including in a pre-clinical program in multiple sclerosis.

    Headquartered in Woburn, Mass., Frequency has an ex-U.S. license and collaboration agreement with Astellas Pharma Inc. for FX-322, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including The Scripps Research Institute, Massachusetts Eye and Ear, Cambridge Enterprises Limited, Mass General Brigham and the Massachusetts Institute of Technology. For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

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  5. Event to be Held January 19, 2021 at 8:00 am ET; Will Feature Prominent Otolaryngology and Audiology Key Opinion Leaders

    Phase 2a Day-90 Readout for FX-322, Frequency's Lead Product Candidate, for Acquired Sensorineural Hearing Loss Anticipated in Late Q1 2021; End of Study Readout in Late Q2 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 plans to host a virtual event and live Q&A session on Tuesday, January 19, 2021 at 8:00 am ET.

    Leading researchers and clinicians, along with Company executives, will discuss current interventions for the treatment of acquired…

    Event to be Held January 19, 2021 at 8:00 am ET; Will Feature Prominent Otolaryngology and Audiology Key Opinion Leaders

    Phase 2a Day-90 Readout for FX-322, Frequency's Lead Product Candidate, for Acquired Sensorineural Hearing Loss Anticipated in Late Q1 2021; End of Study Readout in Late Q2 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 plans to host a virtual event and live Q&A session on Tuesday, January 19, 2021 at 8:00 am ET.

    Leading researchers and clinicians, along with Company executives, will discuss current interventions for the treatment of acquired sensorineural hearing loss (SNHL), unmet medical needs for hearing loss patients and the potential of FX-322 to transform the current standard of care.

    Presenters to include:

    • Robert S. Langer, Sc.D., Scientific Co-Founder; Member of Frequency's Board of Directors; David H. Koch Institute Professor, Massachusetts Institute of Technology
    • Lawrence R. Lustig, M.D., Chair, Department of Otolaryngology – Head and Neck Surgery, Columbia University
    • René H. Gifford, Ph.D., Professor, Hearing and Speech Sciences, Director, Cochlear Implant Program, Vanderbilt University
    • Frank Lin, M.D., Ph.D., Director, Cochlear Center for Hearing and Public Health, Johns Hopkins Bloomberg School of Public Health

    FX-322 is being evaluated in an ongoing double-blind, placebo-controlled, single and repeat dose Phase 2a study in patients aged 18 to 65 with mild to moderately severe acquired SNHL. Frequency expects to share day-90 results from the study in late Q1 2021 and end of study results in late Q2 2021. Acquired SNHL is the primary cause of more than 90 percent of all hearing loss, impacting more than 40 million people in the US alone. Efficacy measures for the Phase 2a study include speech intelligibility (clarity), as measured by standard, validated word recognition (WR) and words-in-noise (WIN) testing. Exploratory efficacy measures include pure tone audiometry at extended high frequencies (up to 16kHz) that are known to contribute to speech intelligibility, as well as assessments of tinnitus and quality of life measures.

    The Company is also conducting two Phase 1b clinical studies to evaluate the potential of FX-322 to provide benefit to additional patient groups, including patients with age-related hearing loss, and individuals with severe SNHL. Clinical study results are also expected in Q2 2021 for a Phase 1b study of FX-322 in patients with age-related hearing loss and in Q3 2021 for the Phase 1b study in patients with severe SNHL.

    Event Details:

    To join the webcast and live Q&A on Tuesday, January 19, 2021 at 8:00 a.m. ET, please visit the "Investors & Media" section of the Frequency website at www.investors.frequencytx.com. A webcast replay will be archived on the Frequency Therapeutics website for up to 60 days following the event.

    About Frequency Therapeutics

    Frequency Therapeutics is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The Company's progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue with the aim of developing disease modifying therapies. The Company's lead product candidate, FX-322, is designed to regenerate auditory hair cells to restore hearing function. In a FX-322 Phase 1/2 study, statistically significant and clinically meaningful improvements in key measures of hearing function in patients with sensorineural hearing loss were observed. FX-322 is being evaluated in multiple ongoing clinical studies in patients with sensorineural hearing loss. The Company also is evaluating additional diseases where its PCA approach could create functional tissue, including in a pre-clinical program in multiple sclerosis.

    Headquartered in Woburn, Mass., Frequency has a license and collaboration agreement with Astellas Pharma Inc. for FX-322, for which it retains U.S. rights, as well as additional collaboration and licensing agreements with academic and nonprofit research organizations including The Scripps Research Institute, Massachusetts Eye and Ear, Cambridge Enterprises Limited, Mass General Brigham and the Massachusetts Institute of Technology. For more information, visit www.frequencytx.com and follow Frequency on Twitter @Frequencytx.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the Phase 2a clinical trial, the Phase 1b study of age-related hearing loss, the Phase 1b study of severe SNHL, design, pace and timing of enrollment for the Phase 1b studies in age-related hearing loss and severe SNHL, the timing and completeness of data readouts from the Phase 2a clinical trial and the Phase 1b studies in age-related hearing loss and severe SNHL, the impact of COVID-19 on the Company's on-going and planned clinical trials and business, estimates of the size of the hearing loss population and population at risk for hearing loss, the Company's ability to advance its hearing program and further diversify its portfolio and the potential application of the PCA platform to other diseases.

    These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of COVID-19 on the Company's ongoing and planned clinical trials, research and development and manufacturing activities, the relocation of the Company's offices and laboratory facilities, the Company's business and financial markets; the Company has incurred and will continue to incur significant losses and is not and may never be profitable; the Company's need for additional funding to complete development and commercialization of any product candidate; the Company's dependence on the development of FX-322; the unproven approach of the PCA platform; the lengthy, expensive and uncertain process of clinical drug development and regulatory approval; limited experience successfully obtaining marketing approval for and commercializing product candidates; the results of earlier clinical trials not being indicative of the results from later clinical trials; differences between preliminary or interim data and final data; adverse events or undesirable side effects; disruptions at the FDA and other regulatory agencies; failure to identify additional product candidates; new or changed legislation; failure to maintain Fast Track designation for FX-322 and such designation failing to result in faster development or regulatory review or approval; costly and damaging litigation, including related to product liability or intellectual property or brought by stockholders; dependence on Astellas Pharma Inc. for the development and commercialization of FX-322 outside of the United States; misconduct by employees or independent contractors; reliance on third parties, including to conduct clinical trials and manufacture product candidates; compliance with laws and regulations, including healthcare and environmental, health, and safety laws and regulations; failure to obtain, maintain and enforce protection of patents and other intellectual property; security breaches or failure to protect private personal information; attracting and retaining key personnel; and ability to manage growth.

    These and other important factors discussed under the caption "Risk factors" in the Company's Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 16, 2020 and its other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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