Frequency Therapeutics Provides Business Updates and Third Quarter 2021 Financial Results
Frequency Therapeutics, Inc. (Nasdaq: FREQ) has initiated its Phase 2b study (FX-322-208) for sensorineural hearing loss (SNHL) and reached an FDA agreement on speech perception as the primary efficacy endpoint. The company introduced FX-345, a new candidate for SNHL, and a remyelination program for multiple sclerosis (MS) showcasing promising in vivo results. Financially, cash reserves are at $160.5 million, with a net loss of $25.2 million for Q3 2021, marking a significant increase from 2020. Revenue dropped to $14.1 million for the first nine months of 2021.
- Initiation of Phase 2b study FX-322-208 for SNHL, potentially improving treatment outcomes.
- FDA alignment on speech perception as the primary endpoint mitigates future development risks.
- Introduction of FX-345 could broaden treatment options for SNHL patient populations.
- Promising data from the remyelination program for MS shows significant activity compared to current treatments.
- Cash position of $160.5 million expected to fund operations into late 2023.
- Revenue decreased to $14.1 million for the first nine months of 2021 compared to $27.0 million in 2020.
- Net loss increased to $25.2 million for Q3 2021, up from $5.3 million in Q3 2020.
- Research and development expenses rose significantly, indicating higher operational costs.
Enrollment Underway for FX-322-208 Phase 2b Study in Subjects with Sudden and Noise-Induced Sensorineural Hearing Loss; Aligns with FDA on Speech Perception as Primary Endpoint for FX-322 Studies
Expands Pipeline with
Introduces Remyelination Program in Multiple Sclerosis (MS), Sharing In Vivo Data Showing Substantially Greater Activity than Biologic or Small Molecule Comparators
“Frequency has made significant operational progress throughout this year, highlighted by the initiation of a Phase 2b study (FX-322-208) of FX-322, our lead program for sensorineural hearing loss (SNHL). We have designed this study following careful analysis of multiple completed FX-322 exploratory clinical studies, and through this work, we’ve increased our understanding of the specific patient etiologies and severities where hearing benefits were observed. We have also reached alignment with the
“At our recent R&D event, we detailed results from our completed FX-322 clinical studies, showing all of the data demonstrating a clear signal of clinical benefit in a significant segment of individuals with SNHL. We also showed how the breadth of our clinical efforts informed the inclusion criteria of our ongoing FX-322-208 Phase 2b study. Furthermore, we were excited to introduce two new research programs, the first a pre-clinical development candidate to treat SNHL that can reach deeper into the cochlea and which may provide the opportunity to treat different patient populations. The second is a novel candidate for remyelination in MS that has shown significant remyelinating effect in vivo and has the potential to provide a highly differentiated offering compared to currently approved MS treatments.”
FX-322 Clinical Study Overview and Recent Corporate Highlights
FX-322-208 Phase 2b Study in Acquired SNHL: In October, Frequency announced that the first subject was dosed in a new Phase 2b study of acquired SNHL. FX-322-208 is a randomized, placebo-controlled, multi-center study designed to evaluate the impact of a single administration of FX-322 on speech perception in approximately 124 subjects with SNHL.
The study’s primary endpoint is speech perception, a measure of sound clarity and understanding speech. FX-322-208 will include subjects with hearing loss associated with either noise-induced or sudden SNHL. The FDA, in a recent Type-C meeting with the Company, agreed that speech perception is an acceptable primary efficacy endpoint. A variety of other listening tests, including multiple measures of speech perception and pure tone thresholds, will also be assessed. Based on learnings from prior studies, extensive study design elements have been included in FX-322-208 to mitigate potential bias and help ensure the consistency of baseline hearing assessments.
Since 2018, Frequency has run exploratory learning studies with the aim of determining the optimal patient populations where FX-322 may restore lost hearing. Given the diversity of etiologies and severities and the heterogeneity of hearing loss, this comprehensive approach was utilized to narrow in on the target population for further development. Data from these studies has enabled Frequency to design the FX-322-208 study inclusive of the hearing loss etiologies and severities where speech perception improvements were observed in prior FX-322 clinical studies.
To date, 169 individuals have been dosed with FX-322 across previous studies and no drug-related serious adverse events have been reported. The Company is also planning in Q4 2021 to report data from its FX-322-113 Phase 1b study in subjects with severe SNHL.
Introduction of FX-345, a
Frequency developed multiple novel chemical entities that induce robust remyelination in vivo, including FREQ-162, which is its most advanced compound to date. A single dose of FREQ-162 induces robust increases in oligodendrocyte differentiation throughout the brain and significant remyelination in extensively demyelinated, aged mice. The Company is progressing these assets in dose range finding studies and IND-enabling toxicology studies in order to advance the program into clinical trials. FREQ-162 is one of several compounds Frequency has discovered that show potent remyelination activity. Remyelination is believed to slow or even reverse progression of disability in MS patients.
Third Quarter 2021 Financial Results
Cash Position: Cash, cash equivalents and marketable securities as of
Revenue: Revenue was
Research & Development Expenses: Research and development expenses were
General and Administrative Expenses: General and administrative expenses were
Net Loss: Net loss was
About
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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 2b trial of FX-322, including the type of SNHL that the enrolled patients will have and the ability of design features to reduce bias, 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, FX-345, and the novel approach for remyelination in multiple sclerosis, the timing and progress of the FX-345 and remyelination programs, 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, the potential application of the PCA platform to other diseases, the license and collaboration with Astellas Pharma Inc., and the sufficiency of the Company’s capital resources.
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 PCA platform and the inability to identify additional potential product candidates; the lengthy, expensive and uncertain process of clinical drug development and regulatory approval; the Company’s 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; ability to seek and receive Breakthrough Therapy designation for FX-322; the Company’s ability to enroll and retain patients in clinical trials; 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
Consolidated Statements of Operations (in thousands, except share and per share amounts) (unaudited)
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Three Months Ended
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Nine Months Ended
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2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
||||
Revenue |
|
$ |
— |
|
|
$ |
11,247 |
|
|
$ |
14,068 |
|
|
$ |
27,034 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
15,662 |
|
|
|
10,153 |
|
|
|
48,169 |
|
|
|
25,587 |
|
General and administrative |
|
|
9,328 |
|
|
|
6,512 |
|
|
|
28,571 |
|
|
|
18,720 |
|
Total operating expenses |
|
|
24,990 |
|
|
|
16,665 |
|
|
|
76,740 |
|
|
|
44,307 |
|
Loss from operations |
|
|
(24,990 |
) |
|
|
(5,418 |
) |
|
|
(62,672 |
) |
|
|
(17,273 |
) |
Interest income |
|
|
172 |
|
|
|
74 |
|
|
|
315 |
|
|
|
962 |
|
Interest (expense) |
|
|
(182 |
) |
|
|
— |
|
|
|
(582 |
) |
|
|
— |
|
Realized (loss) gain on investments |
|
|
(9 |
) |
|
|
— |
|
|
|
(23 |
) |
|
|
65 |
|
Foreign exchange (loss) gain |
|
|
(4 |
) |
|
|
18 |
|
|
|
16 |
|
|
|
27 |
|
Other (expense), net |
|
|
(139 |
) |
|
|
— |
|
|
|
(227 |
) |
|
|
— |
|
Loss before income taxes |
|
|
(25,152 |
) |
|
|
(5,326 |
) |
|
|
(63,173 |
) |
|
|
(16,219 |
) |
Income taxes |
|
|
(3 |
) |
|
|
(15 |
) |
|
|
(13 |
) |
|
|
(60 |
) |
Net loss |
|
$ |
(25,155 |
) |
|
$ |
(5,341 |
) |
|
$ |
(63,186 |
) |
|
$ |
(16,279 |
) |
Net loss per share attributable to common stockholders-basic and diluted |
|
$ |
(0.73 |
) |
|
$ |
(0.16 |
) |
|
$ |
(1.84 |
) |
|
$ |
(0.51 |
) |
Weighted-average shares of common stock outstanding-basic and diluted |
|
|
34,448,746 |
|
|
|
33,073,889 |
|
|
|
34,268,736 |
|
|
|
31,729,702 |
|
Consolidated Balance Sheet Data (in thousands) (unaudited)
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|
|
|
|
|
|
|
||
Cash, cash equivalents and marketable securities |
|
$ |
160,471 |
|
|
$ |
220,341 |
|
Working capital |
|
|
139,424 |
|
|
|
198,430 |
|
Total assets |
|
|
202,185 |
|
|
|
264,722 |
|
Total liabilities |
|
|
55,069 |
|
|
|
72,231 |
|
Accumulated deficit |
|
|
(158,585 |
) |
|
|
(95,399 |
) |
Total stockholders' equity |
|
|
147,116 |
|
|
|
192,491 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20211115005072/en/
Investor:
Kendall Investor Relations
ctanzi@kendallir.com
617-914-0008
Media:
sday@frequencytx.com
781-496-2211
Source:
FAQ
What is the FX-322-208 Phase 2b study for FREQ?
When did Frequency Therapeutics report its third quarter financial results?
What were the revenue figures for Frequency Therapeutics in Q3 2021?
What is the cash position of Frequency Therapeutics as of September 30, 2021?
What are the plans for FX-345 and the remyelination program?
