Q1 2023 Readout Planned for FX-322-208 Phase 2b
Sensorineural Hearing Loss Study, with Enrollment Completion
Anticipated in Q3
Q4 Enrollment Start Planned for Phase 1b Study
of Second Hearing Restoration Program, FX-345
Company Advances Remyelination in Multiple
Sclerosis Program, Remains on Pace for 2023 Clinical Start
Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage
regenerative medicine company focused on developing therapeutics to
activate a person’s innate potential to restore function, today
announced business updates and financial results for the second
quarter ended June 30, 2022.
“I am very pleased with our team’s pipeline execution and the
clear progress across all of our clinical and pre-clinical
programs. We have reached a predictable cadence in our FX-322-208
enrollment, giving us confidence in our timelines for a Phase 2b
study readout in Q1 2023. The rigorous FX-322-208 study design
includes an extended lead-in period to ensure the stability of an
individual’s hearing prior to entering the trial, and we have
narrowed participation to individuals with the etiologies and
severities where we have observed the strongest hearing signal in
prior FX-322 studies,” said David L. Lucchino, Frequency’s chief
executive officer.
“Our second hearing restoration candidate, FX-345, which is
designed to gain better distribution in the cochlea to potentially
address sensorineural hearing loss in a broader set of individuals,
remains on track to commence enrollment later this year. Our
remyelination in multiple sclerosis program also is progressing
very well as we advance a candidate toward IND-enabling studies,
and I am very pleased with the pace and productivity of our
research group as we work to move that program into the clinic in
2023. Across the enterprise, we continue to carefully manage
expenses and have cash sufficient to move our programs through
important data events and milestones.”
Recent Pipeline Progress and Corporate
Highlights
FX-322-208 Phase 2b Study in Acquired Sensorineural Hearing
Loss (SNHL): FX-322-208 is a randomized, placebo-controlled,
multi-center study designed to evaluate the efficacy of a single
administration of FX-322 on speech perception in approximately 124
subjects with SNHL. The FX-322-208 Phase 2b study includes subjects
with hearing loss associated with either noise-induced or sudden
SNHL. The study’s pre-specified primary efficacy endpoint is the
improvement in a measure of speech perception, the ability to hear
more words correctly, and the Company has aligned with the US Food
and Drug Administration (FDA) on this endpoint. Study enrollment is
progressing with approximately 30 clinical sites in operation
across the US.
FX-345, a Second Program for SNHL: FX-345 is the
Company’s second investigational therapeutic candidate for SNHL.
Pharmacokinetic measures and human modeling data suggest that
administration of FX-345 can result in therapeutically active drug
levels in a larger portion of the cochlea, which could potentially
address a broader set of patients with SNHL. The Company intends to
conduct a Phase 1b study in subjects with SNHL to assess safety,
exposure and preliminary impact on a number of audiometric measures
and anticipates the study commencing in the fourth quarter of this
year.
Pre-clinical Program for Remyelination in Multiple Sclerosis
(MS): The Company is advancing to IND-enabling studies its
program for remyelination in MS. As announced late last year, the
Company identified a new biological target relevant to myelination
and demonstrated that modulation of this target drives robust
oligodendrocyte differentiation and expression of myelin proteins
in vitro. Multiple novel chemical entities have been identified
that induce robust remyelination in an in vivo animal model. The
Company plans to advance a candidate into clinical studies in
2023.
Sublease Agreement: On July 8, 2022, the Company entered
into a two-year agreement to sublease excess laboratory and office
space, significantly reducing expenses. The Company has sufficient
laboratory and other workspace for its teams and to support
upcoming milestones and future plans.
Second Quarter 2022 Financial
Results
Cash Position: Cash, cash equivalents and marketable
securities as of June 30, 2022, were $111.0 million (excluding
restricted cash). The Company is believed to be appropriately
resourced to advance its pipeline of potential first-in-class
treatments through key development milestones, including completion
of the Phase 2b study of FX-322, a Phase 1b study of FX-345 and a
Phase 1 study for the MS program.
Based on current plans and assumptions, the Company believes its
existing cash, cash equivalents and marketable securities will be
sufficient to fund its operations into 2024. This guidance does not
include potential future milestones which could be received from
Astellas Pharma Inc. (Astellas) for continued FX-322
development.
Revenue: The $80.0 million upfront payment from Astellas,
initially recorded as deferred revenue, was fully recognized as of
June 30, 2021. As such, no revenue was recorded for the three and
six months ended June 30, 2022, compared to $9.4 million and $14.1
million in the comparable periods of 2021.
Research and Development Expenses: Research and
development expenses were $13.3 million for the three months ended
June 30, 2022, as compared to $17.4 million for the comparable
period of 2021. Research and development expenses were $27.1
million for the six months ended June 30, 2022, as compared to
$32.5 million for the comparable period of 2021. Excluding
stock-based compensation expense of $1.6 million for the three
months ended June 30, 2022 and $3.9 million for the six months
ended June 30, 2022, research and development expenses for the
three and six months ended June 30, 2022, were $11.7 million and
$23.2 million, respectively.
General and Administrative Expenses: General and
administrative expenses were $8.0 million for the three months
ended June 30, 2022, as compared to $9.5 million for the comparable
period of 2021. General and administrative expenses were $17.5
million for the six months ended June 30, 2022, as compared to
$19.2 million for the comparable period of 2021. Excluding
stock-based compensation expense of $3.0 million for the three
months ended June 30, 2022 and $5.9 million for the six months
ended June 30, 2022, general and administrative expenses for the
three and six months ended June 30, 2022 were $5.0 million and
$11.6 million, respectively.
Net Loss: Net loss was $21.3 million for the three months
ended June 30, 2022, as compared to $17.7 million for the
comparable period of 2021. Net loss was $44.7 million for the six
months ended June 30, 2022, as compared to $38.0 million for the
comparable period of 2021. The period over period increases in net
loss were primarily due to a decrease in revenue for the three and
six months ended June 30, 2022.
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 – 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 and the Scripps Research
Institute.
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 timing and design of the Phase 2b study (FX-322-208),
including the timing of topline results 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 timing
and progress of the FX-345 and remyelination programs, including
the timing of INDs and clinical trials, the treatment potential of
FX-322, FX-345, and the novel approach for remyelination in MS, the
sufficiency of the Company’s laboratory and other workspaces, the
sufficiency of the Company’s capital resources, the acceptance by
the FDA of particular endpoints in the Company’s trials, the
license and collaboration with Astellas Pharma Inc., and the
potential application of the progenitor cell activation (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 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 the United
States; misconduct by employees or independent contractors;
reliance on third parties, including to conduct clinical trials and
manufacture product candidates; compliance with changing laws and
regulations, including healthcare and environmental, health, data
privacy and safety laws and regulations; failure to obtain,
maintain and enforce protection of patents and other intellectual
property rights covering product candidates; security breaches or
failure to protect private personal information; attracting and
retaining key personnel; and the Company’s 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 9, 2022 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.
Frequency Therapeutics,
Inc.
Consolidated Statements of
Operations
(in thousands, except share
and per share amounts)
(unaudited)
Three Months Ended June
30,
Six Months Ended June
30,
2022
2021
2022
2021
Revenue
$
—
$
9,417
$
—
$
14,068
Operating expenses:
Research and development
13,273
17,401
27,054
32,507
General and administrative
8,000
9,499
17,477
19,243
Total operating expenses
21,273
26,900
44,531
51,750
Loss from operations
(21,273
)
(17,483
)
(44,531
)
(37,682
)
Interest income
425
118
520
143
Interest expense
(208
)
(182
)
(386
)
(400
)
Realized gain (loss) on investments
2
(10
)
2
(14
)
Foreign exchange (loss) gain
(3
)
(1
)
(2
)
20
Other expense, net
(226
)
(88
)
(260
)
(88
)
Loss before income taxes
(21,283
)
(17,646
)
(44,657
)
(38,021
)
Income taxes
(2
)
(10
)
(14
)
(10
)
Net loss
$
(21,285
)
$
(17,656
)
$
(44,671
)
$
(38,031
)
Net loss per share attributable to common
stockholders-basic and diluted
$
(0.61
)
$
(0.52
)
$
(1.28
)
$
(1.11
)
Weighted-average shares of common stock
outstanding-basic and diluted
34,976,409
34,238,394
34,894,001
34,177,262
Frequency Therapeutics,
Inc.
Consolidated Balance Sheet
Data
(in thousands)
(unaudited)
June 30, 2022
December 31, 2021
Cash, cash equivalents and marketable
securities
111,016
142,426
Working capital
96,660
123,319
Total assets
149,658
185,358
Total liabilities
53,805
54,534
Accumulated deficit
(224,756
)
(180,085
)
Total stockholders' equity
95,853
130,824
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220809005645/en/
Investor: Carlo Tanzi, Ph.D. Kendall Investor Relations
ctanzi@kendallir.com 617-914-0008
Media: Frequency Therapeutics Email: media@frequencytx.com
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