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Frequency Therapeutics Provides Statement of Support for the Hearing Loss Association of America’s Externally-Led Patient-Focused Drug Development Meeting to Address Sensorineural Hearing Loss

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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.

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  • Frequency Therapeutics is actively involved in advancing patient voices in drug development through its support for HLAA's EL-PFDD meeting.
  • The company is developing FX-322, a potential therapy to restore hearing function for those with SNHL.
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Frequency Therapeutics, Inc., (Nasdaq: FREQ) today shared a statement from David L. Lucchino, Frequency’s Chief Executive Officer, in support of the Hearing Loss Association of America (HLAA) and its efforts to advance the voice of the patient in leading the first-ever Externally-Led Patient-Focused Drug Development (EL-PFDD) meeting on sensorineural hearing loss (SNHL).

Patient-Focused Drug Development meetings are designed to provide the U.S. Food and Drug Administration (FDA) an opportunity to hear directly from patients, their families, caregivers and advocates on the impact of disease on daily life and their experiences with currently available interventions. This input helps inform the FDA’s decisions and oversight both during drug development and review of marketing applications for new drugs. This is the first program focused specifically on SNHL, the most common form of hearing loss.

SNHL typically results from damage to the inner ear, also called the cochlea. This damage may occur due to chronic noise exposure, aging, certain viral infections or exposure to drugs that are toxic to the ear. This type of damage impacts hundreds of millions of individuals worldwide.

“HLAA has been empowering patients with hearing loss for decades and continues to be at the forefront of championing the needs of individuals impacted by hearing loss. Their efforts are essential to elevating the voice of patients and caregivers by building awareness of the need for greater access to treatment and to advance new areas of innovation. As ongoing research and development progresses for a wide range of therapeutics and modalities to potentially repair or restore hearing, understanding the benefits and gaps in the current standard of care will be crucial in helping inform future discussions on the role of new treatment options for patients and providers. HLAA’s impact is evident by the breadth of organizations they have convened for this meeting, spotlighting the extent of the need for new advances in the field of hearing and the impact of hearing health on overall health. Their work to drive this EL-PFDD meeting will provide a crucial window into the lives of individuals who struggle with sensorineural hearing loss, the impact of the condition on their quality of life and the need to bring new solutions to patients in this underserved area of medicine.”

The Externally-Led Patient Focused Drug Development meeting on SNHL will be held on Tuesday, May 25, from 10 a.m. to 3 p.m. ET. Interested parties may register for the virtual interactive meeting through HLAA’s website, www.hearingloss.org.

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 Lexington, 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, 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.

FAQ

What is Frequency Therapeutics doing regarding sensorineural hearing loss?

Frequency Therapeutics is supporting HLAA's Externally-Led Patient-Focused Drug Development meeting to advocate for patient input on treatments for sensorineural hearing loss.

When is the EL-PFDD meeting on sensorineural hearing loss scheduled?

The EL-PFDD meeting will be held on May 25, 2021, from 10 a.m. to 3 p.m. ET.

What is FX-322 and how does it relate to hearing loss?

FX-322 is Frequency Therapeutics' lead product candidate designed to regenerate auditory hair cells to restore hearing function in patients with sensorineural hearing loss.

Frequency Therapeutics, Inc.

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