Company Plans to Commence New FX-322 Phase 2
Study in Q4 2021 in a Refined Population of Individuals with
Sensorineural Hearing Loss (SNHL)
Will Host R&D Event on November 9th to
Provide Detailed Insights into FX-322 Clinical Data, Plans for
Continued FX-322 Development and New Pipeline Advancements for
Hearing Loss and Multiple Sclerosis
Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage
biotechnology company focused on harnessing the body’s innate
biology to repair or reverse damage caused by a broad range of
degenerative diseases, today announced business updates and
financial results for the second quarter ended June 30, 2021.
“We have made important progress in our efforts to advance
FX-322, our lead program for SNHL, toward its next step in clinical
development. We are now completing a thorough analysis of our
FX-322 exploratory clinical studies, which has served to increase
our understanding of the etiologies and severities where hearing
benefits have been observed in study subjects. Based on the overall
learnings from multiple completed studies, we plan to initiate a
randomized and well-controlled Phase 2 trial in the fourth quarter
of this year, using a single administration of FX-322 in a refined
population of subjects with SNHL. In addition, this trial will
incorporate several novel study design elements that we believe
will help address previously observed study bias,” said David L.
Lucchino, Frequency’s Chief Executive Officer. “In the fourth
quarter, we also intend to share topline data from our FX-322 Phase
1b learning study of subjects with severe SNHL (FX-322-113). Our
plan is to maintain flexibility in the design of the new Phase 2
trial so we may also incorporate insights from the study of severe
SNHL subjects.”
“This November, we will host an R&D event for investors
where we will detail findings from all of our FX-322 clinical
studies. These insights have provided the basis for our enthusiasm
in the program and have informed the design of our upcoming Phase 2
clinical trial. In addition, we plan to discuss other potential
near-term and longer-term areas of pipeline expansion, including
continued advancements in hair cell regeneration, as well as the
progress we have made in our preclinical program for remyelination
in multiple sclerosis (MS), our scientific approach toward compound
selection and the in vivo data that we believe supports our MS
program,” Mr. Lucchino concluded.
Clinical Study Overview and Recent Corporate
Highlights
Sensorineural hearing loss is the most common form of hearing
loss, typically resulting from damage to auditory sensory hair
cells in the inner ear. These cells convert sound waves to signals
sent to the brain. Sensory hair cells may be lost due to noise
exposure, aging, certain viral infections or exposure to drugs that
are toxic to the ear.
Frequency’s lead clinical development program has included
numerous learning studies that have examined different SNHL
severities and etiologies, as well as durability of benefit and the
impact of various delivery approaches to best understand target
populations and administration approaches for continued FX-322
development. In a Phase 1/2 study of subjects with mild to
moderately severe SNHL (FX-322-201) the Company observed
statistically significant and clinically meaningful improvements in
key measures of hearing loss. In March 2021, the Company shared
data from an open-label study of FX-322 (FX-322-111), that, similar
to the Phase 1/2 study, showed an improvement in word recognition
scores, including a near doubling of these scores in certain
patients with stable SNHL.
FX-322-113 Phase 1b Study in Severe SNHL: In November
2020, Frequency commenced a Phase 1b study in patients aged 18-65
with severe SNHL (FX-322-113). The study is fully enrolled with 31
subjects. The primary objectives of the study are to assess the
local and systemic safety of a single dose of FX-322 and evaluate
hearing responses in a more severe adult cohort. Study participants
are randomized 4:1 to receive either FX-322 or placebo in one ear.
Validated measures of hearing function including speech perception
and pure tone audiometry are utilized in the study. Safety,
otologic and audiologic assessments are being conducted at days 30
and 90 following administration of FX-322 or placebo. Frequency
expects to share topline results from this study in Q4 2021.
Remyelination in Multiple Sclerosis: Frequency continues
to advance its preclinical research efforts designed to repair
neurological damage in patients with MS. Research efforts are
underway to optimize lead compounds with potent remyelination
activity that have favorable brain penetration and pharmacokinetic
properties. The Company plans to provide additional details on its
MS preclinical program at its November 2021 R&D event.
Support for Patient-Focused Drug Development Event on
Sensorineural Hearing Loss: In May 2021, the Company issued a
statement of support for the Hearing Loss Association of America’s
externally led Patient-Focused Drug Development (PFDD) meeting held
to address the patient experience in sensorineural hearing loss.
The meeting was designed to provide the U.S. Food and Drug
Administration (FDA) with an opportunity to hear directly from
patients, their families and caregivers, and advocates on the
impact of hearing loss on daily life and their experiences with
currently available interventions in order to inform the FDA’s
decisions and oversight both during drug development and review of
marketing applications for new drugs.
Second Quarter 2021 Financial Results
Cash Position: Cash, cash equivalents and marketable
securites as of June 30, 2021 were $175.5 million, as compared to
$220.3 million as of December 31, 2020. Based on current plans and
assumptions, the Company expects its existing cash, cash
equivalents and marketable securities will be sufficient to fund
its operations into 2023. This guidance does not include potential
future milestones which could be received from Astellas for
continued FX-322 development.
Revenue: Revenue was $9.4 million and $14.1 million for
the three and six month periods ended June 30, 2021, respectively.
The Company had revenue of $8.5 million and $15.8 million in the
comparable periods of 2020.
Research & Development Expenses: Research and
development expenses were $17.4 million and $32.5 million for the
three and six month periods ended June 30, 2021, respectively, as
compared to $8.8 million and $15.4 million for the comparable
periods of 2020. The increase was due to increased costs related to
the Company’s lead product candidate, FX-322, including external
development costs related to the Company’s ongoing trials for
FX-322, as well as increased personnel-related costs due to
additional headcount to support the growth of Frequency’s research
and development organization. Excluding stock-based compensation
expense of $3.1 million for the three months ended June 30, 2021
and $4.6 million for the six months ended June 30, 2021, research
and development expenses for the three and six months ended June
30, 2021 were $14.3 million and $27.9 million, respectively.
General and Administrative Expenses: General and
administrative expenses were $9.5 million and $19.2 million for the
three and six months ended June 30, 2021, respectively, as compared
to $6.0 million and $12.2 million for the comparable periods of
2020. The increase was primarily due to an increase in
personnel-related costs, including stock-based compensation, for
additional headcount required to support the growth of the Company
as well as costs associated with being a public company, primarily
comprised of professional fees. Excluding stock-based compensation
expense of $3.0 million for the three months ended June 30, 2021
and $6.1 million for the six months ended June 30, 2021, general
and administrative expenses for the three and six months ended June
30, 2021 were $6.5 million and $13.1 million, respectively.
Net Loss: Net loss was $17.7 million and $38.0 million
for the three and six months ended June 30, 2021, respectively, as
compared to $6.0 million and $10.9 million for the comparable
periods of 2020. The increase in net loss reflects the increase in
research and development costs associated with the growth of
Frequency’s research and development organization as well as the
increase in general and administrative expenses required to support
the growth of Frequency as a public company.
About Frequency Therapeutics
Frequency Therapeutics is a leader in the development of
medicines designed to activate progenitor cells within the body to
treat degenerative diseases. The Company’s progenitor cell
activation (PCA) approach stimulates progenitor cells to create
functional tissue with the aim of developing disease modifying
therapies. The Company’s lead product candidate, FX-322, is
designed to regenerate auditory hair cells to restore hearing
function. FX-322 is being evaluated in multiple ongoing clinical
studies in patients with sensorineural hearing loss. The Company
also is evaluating additional diseases where its PCA approach could
create functional tissue, including in a pre-clinical program in
multiple sclerosis.
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 initiation, timing and design of the new Phase 2
trial of FX-322, including the ability of study design to address
study bias, the interpretation and implications of the results of
the Phase 2a, FX-322-111, FX-322-201 and FX-322-112 data, the
timing and results of top-line data from the Phase 1b study
(FX-322-113) in severe SNHL, the design and timing of future
studies of and clinical development path of FX-322, the treatment
potential of FX-322, and our program to develop a product candidate
for the treatment of multiple sclerosis; the ability of our
technology platform to provide patient benefit, the ability to
continue to develop our PCA platform and identify additional
product candidates, the timing of and content to be disclosed
during the R&D event, the timing and progress of the Company’s
remyelination program, the sufficiency of the Company’s capital
resources, the implementation of our strategic plans for our
business, product candidates and technology, the license and
collaboration agreements, including with Astellas Pharma Inc., 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.
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,
2021
2020
2021
2020
Revenue
$
9,417
$
8,523
$
14,068
$
15,787
Operating expenses:
Research and development
17,401
8,764
32,507
15,434
General and administrative
9,499
5,959
19,243
12,208
Total operating expenses
26,900
14,723
51,750
27,642
Loss from operations
(17,483
)
(6,200
)
(37,682
)
(11,855
)
Interest income
118
178
143
888
Interest (expense)
(182
)
—
(400
)
—
Realized (loss) gain on investments
(10
)
(4
)
(14
)
65
Foreign exchange (loss) gain
(1
)
8
20
9
Other (expense), net
(88
)
—
(88
)
—
Loss before income taxes
(17,646
)
(6,018
)
(38,021
)
(10,893
)
Income taxes
(10
)
(7
)
(10
)
(45
)
Net loss
$
(17,656
)
$
(6,025
)
$
(38,031
)
$
(10,938
)
Net loss per share attributable to common
stockholders-basic and diluted
$
(0.52
)
$
(0.19
)
$
(1.11
)
$
(0.35
)
Weighted-average shares of common stock
outstanding-basic and diluted
34,238,394
31,066,686
34,177,262
30,967,453
Frequency Therapeutics, Inc.
Consolidated Balance Sheet Data (in thousands)
(unaudited)
June 30, 2021
December 31, 2020
Cash, cash equivalents and marketable
securities
$
175,524
$
220,341
Working capital
163,333
198,430
Total assets
220,213
264,722
Total liabilities
54,173
72,231
Accumulated deficit
(133,430
)
(95,399
)
Total stockholders' equity
166,040
192,491
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210812005055/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
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