Press Release

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

WOBURN, Mass.--(BUSINESS WIRE)--Dec. 18, 2020-- 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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201218005149/en/

Investor Contact:
Carlo Tanzi, Ph.D.
Kendall Investor Relations
Tel: 617-914-0008
ctanzi@kendallir.com

Media Contact:
Suzanne Day
Frequency Therapeutics
Tel: 781-496-2211
Email: sday@frequencytx.com

Source: Frequency Therapeutics, Inc.