Frequency Therapeutics Virtual R&D Event to Detail FX-322 Clinical Advances, a New Program for Hearing Restoration and In Vivo Data from its MS Remyelination Program

Rhea-AI Summary

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.

Positive

• FDA agreed on speech perception as the primary endpoint for FX-322 studies.
• New FX-322-208 Phase 2b study initiated focusing on enriched patient populations for improved speech perception.
• Company's second hearing restoration program may expand treatment options for SNHL.

Negative

• None.

At Nov. 9 Event, Management and Key Opinion Leaders to Review Detailed FX-322 Clinical Study Results in Patients with Sensorineural Hearing Loss (SNHL) and Design of New FX-322-208 Phase 2b Study

Company to Introduce a Second Hearing Restoration Program with a Differentiated Biological Profile and Greater Coverage into the Cochlea, Providing Potential to Expand Addressable SNHL Patient Populations

Key Research Findings for a Novel Remyelinating Agent Being Advanced for Multiple Sclerosis (MS) also to be Presented

LEXINGTON, Mass.--(BUSINESS WIRE)-- Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative medicine company focused on developing therapeutics to activate a person’s innate regenerative potential to restore function, today announced that the Company will be hosting a virtual R&D event on November 9, 2021.

At the event, Frequency’s clinical leaders will provide a detailed review of data from nearly 170 subjects dosed with FX-322. A rigorous statistical analysis of these clinical data uncovered the patient populations most likely to benefit from FX-322 and these patients are now being recruited in the Company’s recently initiated FX-322 Phase 2b study (FX-322-208). Key opinion leaders in auditory science and clinical study design will provide insights on FX-322 clinical results and the strategy supporting the new FX-322-208 trial.

The FX-322-208 study is designed to demonstrate improved speech perception in an enriched population of individuals with SNHL where statistically significant and clinically meaningful hearing improvements in speech perception were observed in prior trials. The U.S. Food and Drug Administration (FDA) recently agreed with speech perception as the primary endpoint for FX-322 development, including for the FX-322-208 study and all future FX-322 studies.

In addition to discussing clinical development advances, the company will unveil two new advanced research programs:

• A new candidate to treat sensorineural hearing loss that delivers a regenerative therapeutic that may provide greater coverage and increased potency at the site of action within the inner ear, that may enable the treatment of different SNHL patient populations at varying dose levels and;
• A novel approach for remyelination in multiple sclerosis, including in vivo findings showing potent biological activity and a comparison of this program to other leading approaches.

Event Details and Agenda:

The webcast event is scheduled for November 9 from 8 a.m. to 10 a.m. ET, and will include a live Q&A session. Following are the list of management and key opinion leaders that are expected to present and their areas of focus:

• David L. Lucchino, Chief Executive Officer: Strategic Company overview.
• Robert S. Langer, ScD, a Frequency Therapeutics scientific co-founder and MIT Institute Professor: Pioneering a new category in regenerative medicine.
• Carl LeBel, PhD, Chief Development Officer: FX-322 hearing restoration program and the clinical development path.
• Sumit Dhar, PhD, Hugh Knowles Professor of Hearing Science and Associate Provost for Faculty at Northwestern University: Cochlear pathology and the impact of high frequencies on speech perception.
• Kevin Franck, PhD, SVP, Strategic Marketing and New Product Planning: FX-322 clinical data and review of responders.
• Steven D. Targum, MD, Scientific Director, Signant Health: Best-practice approaches for addressing placebo response in clinical trials.
• Christopher Loose, PhD, Chief Scientific Officer: Continued progenitor cell activation (PCA) research, drug delivery advances and overview of a new regenerative hearing program.
• Sanjay Magavi, PhD, VP, Myelination Research: In Vivo data for a novel pre-clinical program for remyelination in multiple sclerosis.

To register for the virtual event and watch a live webcast of the presentation, please visit the Investor’s & Media section of the Frequency Therapeutics website at https://investors.frequencytx.com/2021_Virtual_R-D_Event. An archived replay will be available for at least 30 days following the presentation.

About Frequency Therapeutics

Frequency Therapeutics is leading a new category in regenerative medicine that aims to restore human function – first in hearing loss and then in multiple sclerosis (MS) – by developing therapeutics that activate a person’s innate regenerative potential within the body through the activation of progenitor cells. Frequency’s hearing research focuses on cochlear restoration and auditory repair, and its lead asset, FX-322, is a small-molecule product candidate that is the first to show statistically significant and clinically meaningful hearing improvements in clinical trials for sensorineural hearing loss. Frequency is also following early restorative signals in MS to develop medicines with the same underlying regenerative science being brought to hearing loss.

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, 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 design of the new Phase 2 trial of FX-322, including, the type of SNHL that the enrolled patients will have, the interpretation and implications of the results and learnings of other FX-322 clinical studies, the acceptance by the FDA of particular endpoints in the Company’s trials, the treatment potential of FX-322 as well as the novel approach for remyelination in multiple sclerosis and our new candidate to treat SNHL, the speakers, timing of and topics to be discussed during the R&D event,, the ability of our technology platform to provide patient benefit, the ability to continue to develop our Progenitor Cell Activation (PCA) platform and identify additional product candidates, 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 August 12, 2021 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/20211027005536/en/

Investors:

Carlo Tanzi, Ph.D.

Kendall Investor Relations

ctanzi@kendallir.com

617-914-0008



Media:

Suzanne Day

Frequency Therapeutics

sday@frequencytx.com

781-496-2211

Source: Frequency Therapeutics, Inc.

FAQ

What is Frequency Therapeutics announcing on November 9, 2021?

Frequency Therapeutics is hosting a virtual R&D event to discuss FX-322 clinical study results and the design of the new FX-322-208 Phase 2b study.

What are the key findings of the FX-322 clinical study?

The study involved nearly 170 subjects and identified patient populations likely to benefit from FX-322, with a focus on improved speech perception.

What is the purpose of the FX-322-208 study?

The FX-322-208 study aims to demonstrate improved speech perception in individuals with sensorineural hearing loss.

What new programs will be introduced at the Frequency Therapeutics event?

The company will introduce a second hearing restoration program and a novel remyelinating agent for multiple sclerosis.

How does the FDA's agreement impact FX-322 development?

The FDA's agreement to use speech perception as a primary endpoint supports the clinical development strategy for FX-322.