Item 7.01. Regulation FD Disclosure.
On
The information in Item 7.01 of this Current Report, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as expressly set forth by specific reference in such filing. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.
Item 8.01. Other Events.
On
Including the five initial responders, there are now a total of nine subjects that participated in the FX-322-111 study (n=32) that have been shown to have statistically significant improvements in word recognition scores, a key measure of speech perception, at time points between 90 days and one year.
These new results suggest that the hearing of individuals administered with a single dose of FX-322 may improve over extended periods. The longer-term measures of their treated ear demonstrated word recognition score improvements when compared to pre-treatment baseline levels and no significant changes were detected in their untreated ears. Of the five subjects that had a statistically significant response at day-90, the four that returned for evaluation had scores that remained above their baseline word recognition measures, though were below the threshold for statistical significance. The Company plans to assess individuals treated in its other studies to evaluate if those subjects may have experienced these longer-term benefits.
FX-322 is the Company's lead product candidate for the treatment of acquired SNHL, which is the primary cause of more than 90 percent of all cases of hearing loss. FX-322 is designed to regenerate auditory sensory hair cells located in the cochlea within the inner ear and to potentially restore hearing in individuals with SNHL.
The FX-322-111 study is an open-label, multi-center, single-dose trial designed to evaluate the impact of FX-322 injection conditions on tolerability, as well as key measures of hearing benefit. In the study, subjects with mild to severe SNHL (n=33) were injected in one ear with FX-322, with the untreated ear serving as the control. Hearing function was tested in 32 subjects (one subject did not finish the study) over the course of 90 days following dosing. Twenty-five subjects were subsequently evaluated at 8-12 months following FX-322 dosing, with four subjects that had shown improvement trends in word recognition scores at day-90 reaching statistically significant scores when tested at the later time points.
Subjects in the study had an array of hearing loss etiologies, including sudden SNHL, noise-induced SNHL and idiopathic SNHL. Additionally, the subjects ranged in severity from mild to severe. The single dose had a favorable safety profile and both injection conditions were well tolerated. Based on the overall learnings from the multiple FX-322 learning studies, the Company plans to initiate a new FX-322 Phase 2 trial in the fourth quarter of this year to evaluate the impact of single-dose FX-322 administration in a refined population of individuals with SNHL.
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Forward-Looking Statements
This Current Report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Current Report that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the initiation, timing and design of the new Phase 2 trial of FX-322, the interpretation and implications of the results of the FX-322-111 study as well as the results from the follow-up to the FX-322-111 study, the plan to assess individuals in earlier trials for longer-term benefits, and the treatment potential of FX-322.
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 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
Company's 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
These and other important factors discussed under the caption "Risk factors" in
the Company's Form 10-Q filed with the
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
The following exhibit relates to Item 7.01, and shall be deemed to be furnished, and not filed:
Exhibit No. Description 99.1Frequency Therapeutics, Inc. Corporate Slide Presentation as ofSeptember 22, 2021 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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