FX-322-208 Phase 2b Study in Individuals with
Acquired Sensorineural Hearing Loss Remains on Track for a Readout
in Q4 2022 or Q1 2023
Reports Cash and Cash Equivalents of $124.8M,
Providing Runway into 2024; Funds Enable Company to Meet Multiple
Clinical Milestones for Programs Targeting Hearing Loss and
Multiple Sclerosis
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 business updates and financial results
for the first quarter ended March 31, 2022.
“Frequency continues to make important progress executing our
pipeline of therapeutic programs for hearing loss and remyelination
in multiple sclerosis (MS). We have taken steps to preserve
capital, extending our cash runway into 2024 to ensure we have the
resources to advance all of our programs through the next set of
anticipated clinical milestones. These milestones include: FX-322
Phase 2b study results in hearing restoration, which are
anticipated in Q4 2022 or Q1 2023; Phase 1 study results of FX-345,
our second hearing restoration program that aims to distribute drug
deeper into the cochlea and potentially treat additional
individuals with hearing loss; and Phase 1 safety study results for
our remyelination in MS program,” said David L. Lucchino,
Frequency’s Chief Executive Officer.
“Enrollment for the FX-322-208 study in individuals with sudden
and noise-induced sensorineural hearing loss is progressing well
and we are seeing strong patient interest in this trial. We remain
confident that the robust study protocol is driving recruitment of
individuals with the severities and etiologies where we expect
FX-322 to demonstrate the most profound clinical benefits,”
Lucchino added. “We are on track to submit an investigational new
drug application (IND) for FX-345 in the second half of the year
and continue to gain compelling pre-clinical insights as we prepare
to commence our remyelination study in 2023. Overall, we are
encouraged by the advances across our pipeline and in the potential
for these therapeutic candidates to fundamentally transform the
treatment of patients living with hearing loss and MS.”
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 impact 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 endpoint is a measure of
speech perception. Study enrollment is progressing with more than
25 clinical sites in operation across the US, including the first
site at a Veteran’s Administration hospital, which began recruiting
subjects in April.
Based on learnings from five prior FX-322 studies, extensive
design elements have been included in FX-322-208 to mitigate
potential bias and to help ensure the consistency of baseline
hearing assessments. Data from these studies have also enabled
Frequency to design the FX-322-208 study inclusive of the hearing
loss etiologies and severities where speech perception improvements
were previously observed. To date, no drug-related serious adverse
events have been reported by individuals who have been dosed in any
FX-322 study.
FX-345, a Second Sensory Hair Cell Regeneration Program for
SNHL: In November 2021, Frequency announced FX-345 as a new,
highly potent, 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 hearing loss severities and etiologies.
FX-345 is being evaluated in IND-enabling studies and Frequency
anticipates filing an IND application for FX-345 in the second half
of 2022.
Pre-clinical Program for Remyelination in MS: In November
2021, Frequency announced a discovery effort to remyelinate neurons
in the central nervous system to treat MS. The Company has
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 vivo. The Company expects to
finalize selection of a remyelination development candidate in 2022
with plans for an IND submission in 2023.
First Quarter 2022 Financial
Results
Cash Position: Cash, cash equivalents and marketable
securities as of March 31, 2022, were $124.8 million (excluding
restricted cash). These resources are sufficient to fund the
ongoing Phase 2b clinical program for the Company’s lead candidate
for hearing restoration (FX-322); a second pre-clinical program for
hearing restoration (FX-345); and a pre-clinical program for
remyelination in MS. The Company is 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 1 study of FX-345 and a Phase 1 study in
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, representing an
extension to its previously announced guidance. 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
months ending March 31, 2022, compared to $4.7 million in the
comparable period of 2021.
Research & Development Expenses: Research and
development expenses were $13.8 million for the three months ending
March 31, 2022, as compared to $15.1 million for the comparable
period of 2021. The decrease was due to reduced costs for the
direct research and development of MS as the Company progressed in
its research such that it could narrow the scope of efforts leading
up to the selection of a lead remyelination development candidate
for advancement into clinical development. Excluding stock-based
compensation expense of $2.3 million for the three months ending
March 31, 2022, research and development expenses for the three
months ending March 31, 2022, were $11.5 million.
General and Administrative Expenses: General and
administrative expenses were $9.5 million for the three months
ending March 31, 2022, as compared to $9.7 million for the
comparable period of 2021. The decrease was primarily due to a
decrease in professional services fees as the Company leveraged
internal resources. Excluding stock-based compensation expense of
$3.0 million for the three months ending March 31, 2022, general
and administrative expenses for the three months ending March 31,
2022, were $6.5 million.
Net Loss: Net loss was $23.4 million for the three months
ending March 31, 2022, as compared to $20.4 million for the
comparable period of 2021. The period over period increase in net
loss was primarily due to a decrease in revenue for the three
months ended March 31, 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, 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 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, clinical trials and candidate selection, the
treatment potential of FX-322, FX-345, and the novel approach for
remyelination in MS, the sufficiency of the Company’s capital
resources, 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 May 4, 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 March
31,
2022
2021
Revenue
$
—
$
4,651
Operating expenses:
Research and development
13,781
15,106
General and administrative
9,477
9,744
Total operating expenses
23,258
24,850
Loss from operations
(23,258
)
(20,199
)
Interest income
95
25
Interest expense
(178
)
(218
)
Realized loss on investments
-
(4
)
Foreign exchange gain
1
21
Other expense, net
(34
)
—
Loss before income taxes
(23,374
)
(20,375
)
Income taxes
(12
)
—
Net loss
$
(23,386
)
$
(20,375
)
Net loss per share attributable to common
stockholders-basic and diluted
$
(0.67
)
$
(0.60
)
Weighted-average shares of common stock
outstanding-basic and diluted
34,810,676
34,115,682
Frequency Therapeutics,
Inc.
Consolidated Balance Sheet
Data
(in thousands)
(unaudited)
March 31, 2022
December 31, 2021
Cash, cash equivalents and marketable
securities
124,771
142,426
Working capital
107,766
123,319
Total assets
164,939
185,358
Total liabilities
52,269
54,534
Accumulated deficit
(203,471
)
(180,085
)
Total stockholders' equity
112,670
130,824
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220504005229/en/
Investor: Carlo Tanzi, Ph.D. Kendall Investor Relations
ctanzi@kendallir.com 617-914-0008 Media: Suzanne Day Frequency
Therapeutics Tel: 781-496-2211 Email: sday@frequencytx.com
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