TIDMSYNC
RNS Number : 8653R
Syncona Limited
10 November 2021
Syncona Limited
Freeline reports new data from FLT190 and Third Quarter
Financial Results
10 November 2021
Syncona Ltd, a leading healthcare company focused on founding,
building and funding a portfolio of global leaders in life science,
notes that its portfolio company, Freeline Therapeutics Holdings
plc ("Freeline"), a clinical-stage biotechnology company developing
transformative AAV-mediated gene therapies for patients suffering
from inherited systemic debilitating diseases, has announced new
data from its ongoing Phase I/II MARVEL-1 dose-finding clinical
trial of FLT190 for the treatment of Fabry disease and provided
updates on its pipeline programs. Freeline also announced that
Pamela Foulds, MD has been appointed as Chief Medical Officer (CMO)
and reported financial results for the third quarter of 2021.
Highlights:
-- Second patient dosed in Phase I/II trial for Fabry disease
has generated encouraging data, the patient remains off enzyme
replacement therapy more than 16 weeks post-dosing; first patient
shows durable expression of the key enzyme (<ALPHA>-Gal A),
which is absent or markedly deficient in patients, over two years
with promising efficacy
-- Third patient in the trial for Fabry's disease will be dosed
at the same dose level as the second patient with additional safety
monitoring after a case of mild and transient myocarditis was
observed
-- Freeline is evaluating whether additional studies will be
required to enable the business to progress Haemophilia A into the
clinic and the necessity of conducting these additional studies
Outlook: three clinical studies by the end of CY2021 and
multiple data read-outs in CY2022
-- Freeline remains on track to report long-term durability data
from Phase I/II dose-finding trial for Haemophilia B by end of
CY2021
-- The Haemophilia B Phase I/II dose-confirmation study will now
start in Q1 CY2022, instead of by end of CY2021 as the business
engages with the regulatory authorities to update study
protocols
-- In the Phase I/II trial for Fabry's disease, the company
expects to continue patient dosing in Q1 CY2022 with further
interim data outs from the study expected in CY2022
-- On track for trial site initiation for the Phase I/II study
for Gaucher Type 1 by end of CY2021 with data read-outs from the
trial expected in CY2022
Chris Hollowood, Chief Investment Officer of Syncona Investment
Management Limited and Chair of Freeline said: "We are pleased that
Freeline has been able to re-initiate clinical studies and are
encouraged by the data generated by the second patient dosed in the
Phase I/II Fabry's study. We are fully supportive of the safety
protocols recommended by the data monitoring committee and look
forward to seeing further progress from this study.
By the end of the calendar year, the business will have three
live clinical studies with the expected site initiation of its
Phase I/II programme for Gaucher's disease and multiple data
read-outs expected across these programmes in 2022 with the
potential to drive value for the business. We remain excited by the
potential of the therapies the company is developing to have a
meaningful impact on the lives of patients."
The announcement can be accessed on Freeline's website at:
https://www.freeline.life/investors-media/newsroom/ and the full
text of the announcement from Freeline is contained below.
[S]
Enquiries
Syncona Ltd
Annabel Clay / Fergus Witt
Tel: +44 (0) 20 3981 7940
FTI Consulting
Ben Atwell / Natalie Garland-Collins / Tim Stamper
Tel: +44 (0) 20 3727 1000
About Syncona
Syncona's purpose is to invest to extend and enhance human life.
We do this by founding and building a portfolio of global leaders
in life science to deliver transformational treatments to patients
in areas of high unmet need.
Our strategy is to found, build and fund companies around
exceptional science to create a diversified portfolio of 15-20
globally leading healthcare businesses for the benefit of all our
stakeholders. We focus on developing treatments for patients by
working in close partnership with world-class academic founders and
management teams. Our balance sheet underpins our strategy enabling
us to take a long-term view as we look to improve the lives of
patients with no or poor treatment options, build sustainable life
science companies and deliver strong risk-adjusted returns to
shareholders.
Freeline Reports New Data from Fabry Disease Program, Pipeline
and Company Updates, Including Appointment of Pamela Foulds, MD as
Chief Medical Officer, and Third Quarter 2021 Financial Results
Lowest dose cohort of MARVEL-1 trial of FLT190 for Fabry disease
demonstrates durable <ALPHA>-Gal A expression over two years
in the first patient and promising efficacy with near normal
<ALPHA>-Gal A levels in the second patient, who remains off
enzyme replacement therapy more than 16 weeks post-dosing
Third patient in MARVEL-1 to be dosed at 7.5e11 vg/kg dose level
in first quarter 2022 with additional safety monitoring after case
of mild and transient myocarditis observed
FLT201 Phase 1/2 trial for Gaucher disease Type 1 on track for
trial site initiation by year-end; FLT180a Phase 1/2 dose
confirmation trial for hemophilia B to be in clinic by first
quarter 2022
LONDON, November 9, 2021 - Freeline Therapeutics Holdings plc
(Nasdaq: FRLN) (the "Company" or "Freeline"), a clinical-stage
biotechnology company developing transformative AAV-mediated gene
therapies for patients suffering from inherited systemic
debilitating diseases, today announced new data from its ongoing
Phase 1/2 MARVEL-1 dose-finding clinical trial of FLT190 for the
treatment of Fabry disease and provided updates on its pipeline
programs. The Company also announced that Pamela Foulds, MD has
been appointed as Chief Medical Officer (CMO) and reported
financial results for the third quarter of 2021.
"Today we are pleased to announce that enzyme expression data
from the second patient in our Phase 1/2 dose-finding trial of
FLT190 are highly encouraging, with expression of
alpha-galactosidase A reaching near-normal levels and the patient
thus far remaining off enzyme replacement therapy since dosing,"
said Michael Parini, Chief Executive Officer of Freeline. " These
results were achieved in our lowest dose cohort and already FLT190
appears to be having a significant impact on <ALPHA>-Gal A
activity and disease process in Fabry, which is the underlying goal
and promise of the FLT190 program. We also learned that our
proactive immune management regimen, which is being deployed across
all of our programs, has been effective as no elevations of liver
enzymes have been observed throughout the treatment period."
"We are also delighted to further build our leadership team with
the addition of Dr. Pamela Foulds , whom we welcome to Freeline as
our new Chief Medical Officer," said Mr. Parini. "Given our
continued focus on delivering our clinical-stage assets and
identifying new disease opportunities to tackle with our potent
capsid and strong protein engineering capabilities, Pam's expertise
will be invaluable as we evaluate our programs and determine how to
best advance them and unlock the value in our pipeline."
"We will be dosing a third patient in the first dose cohort of
MARVEL-1, which will allow us to gather additional information on a
potential risk of mild and transient myocarditis in this patient
population with underlying and contributory cardiac disease. This
step is consistent with the recommendation of our independent Data
Monitoring Committee, with whom we have worked to review the
data."
" The mild and transient myocarditis was an unexpected
observation in the MARVEL-1 study given the very strong safety
record Freeline has established in hemophilia, where myocarditis
was not observed in the 10 patients treated in the B-AMAZE study,"
said Dr. Atul B. Mehta, formerly Clinical Director of the Lysosomal
Storage Disorders Unit at the Royal Free London NHS Foundation
Trust and Emeritus Professor of Haematology at University College
London. "It's likely that Fabry patients are predisposed to
developing this by virtue of the pre-existing cardiomyopathy they
often have as a result of the disease. Appropriate measures for
even closer observation and monitoring have been introduced to
ensure the safety of future trial participants."
Mr. Parini continued, " As Freeline and others continue to
explore the potential of gene therapy, we are working with
regulatory authorities to update study protocols for FLT180a for
hemophilia B and FLT201 for Gaucher disease Type 1 to include
additional data collection. We believe this proactive step is the
right approach for patients. As a result of these updates, we
expect to initiate the trial of FLT180a in the first quarter of
2022 instead of by the end of this year and continue to anticipate
interim data readouts in 2022 from both trials. We also are working
with regulatory authorities to augment data monitoring for FLT190
and expect to continue patient dosing in the first quarter of 2022
following these updates."
Key Pipeline and Operational Updates
Fabry Disease
-- The Company reported an interim program update on Patients
One and Two and progress in its Phase 1/2 MARVEL-1 dose-finding
trial of FLT190. The data cutoff date was October 6, 2021.
-- Patient Two:
o Patient Two was dosed at the lowest dose cohort of 7.5e11
vg/kg in June 2021 and experienced a sustained and durable response
with an increase in expression of plasma
<ALPHA>-galactosidase A (<ALPHA>-Gal A), the missing
enzyme in Fabry disease, to near normal levels, from 0.0 nmol/hr/mL
at baseline to an average of 3.9 nmol/hr/mL from weeks 6 to 16
post-dosing. Thus far, the patient remains off enzyme replacement
therapy (ERT).
o With respect to safety, the treatment was well-tolerated with
no dose-limiting toxicities or serious adverse events (SAEs). As of
the cutoff date, there were no adverse events higher than Grade 1
(mild). Patient Two has a history of cardiac disease and on routine
weekly monitoring, an incidental finding of changes in cardiac
markers, t roponin-T and electrocardiogram (ECG), was observed,
although the patient was asymptomatic. After evaluation, these
findings were determined to be consistent with mild and transient
myocarditis. Patient 2's troponin-T has since reverted to baseline,
and the ECG remained stable as of the cutoff date. Ventricular
functioning in the heart has remained normal throughout.
o Patient Two has experienced no elevations in liver enzymes
under our current immune management regimen, which has evolved in
response to patient data in the hemophilia B and Fabry
programs.
o The total vector genome (vg) dose Patient Two received was
approximately 40% higher than Patient One due to differences in
their weights. Patient Two saw a 400% increase in enzyme levels
compared with Patient One.
-- Patient One:
o Long-term follow-up from Patient One shows durable response
with plasma <ALPHA>-Gal A activity levels remaining elevated
at two years post-dose and generally steady at an average of three
times baseline. The patient had a subtherapeutic response with
plasma <ALPHA>-Gal A at 0.8-1.3 nmol/hr/mL and restarted ERT
at week six.
o Patient One has experienced no enduring clinical sequelae of
the transient mild myocarditis episode previously reported in 2019.
Ventricular functioning in the heart remained normal throughout
with cardiac magnetic resonance imaging (MRI) showing no evidence
of scarring on follow-up at one- and two-years post-dosing.
-- An independent Data Monitoring Committee (DMC) conducted a
comprehensive review of safety and efficacy data from the two
patients dosed in the lowest dose cohort in the MARVEL-1 trial. The
DMC has recommended that Freeline proceed with dosing a third
patient in the first cohort at the same 7.5e11 vg/kg dose level
with additional cardiac monitoring, which will be followed by an
additional DMC meeting.
-- The Company is engaging with regulatory authorities to update
the study protocols and trial design for FLT190 and expects to
continue patient dosing in the first quarter of 2022 following
these updates. Freeline continues to anticipate interim data
readouts from the MARVEL-1 trial in 2022, sharing further efficacy
and safety data.
Hemophilia B
-- On track to report long-term durability data from the
Company's Phase 1/2 dose-finding trial of FLT180a for the treatment
of hemophilia B by year-end.
-- The Company is engaging with regulatory authorities to update
the study protocol for the Phase 1/2 B-LIEVE dose-confirmation
trial of FLT180a. The protocol changes and subsequent review shifts
guidance by approximately one quarter for the FLT180a program, with
study start expected in the first quarter of 2022 instead of by
year-end 2021. We are currently evaluating the timing of our Phase
3 pivotal trial and filing of a Biologics License Application and
will provide more concrete guidance next year. The Company
continues to anticipate interim data readouts in 2022.
-- Pursuing Accelerated Approval with the U.S. Food and Drug
Administration (FDA) using the surrogate endpoint of factor IX
(FIX) activity levels combined with demonstration of a positive
correlation between 26-week FIX activity levels and 52-week
annualized bleeding rate (ABR), assuming robust data at 26
weeks.
-- Enrollment in the ECLIPSE run-in study for the Phase 1/2
B-LIEVE dose-confirmation trial of FLT180a is proceeding more
quickly than expected. As a result, we believe we have identified a
sufficient number of patients to fully enroll the B-LIEVE
trial.
Gaucher Disease Type 1
-- Announced Orphan Drug Designations for FLT201 for the
treatment of Gaucher disease Type 1 from the FDA and European
Commission (EC).
-- The Company is engaging with regulatory authorities to update
the study protocol for the Phase 1/2 dose-finding trial of FLT201
and remains on track for trial site initiation by year end 2021. We
continue to expect trial start and interim data readouts on safety
and efficacy in 2022.
Hemophilia A
-- The Company expects to complete ongoing preclinical studies
of FLT210 for the treatment of hemophilia A by year end as
previously anticipated. Based on data generated in these studies to
date, the Company is evaluating whether additional studies will
enhance an IND filing and the necessity of conducting these
additional studies.
Platform Technology
-- The Company presented two preclinical posters at the 2021
European Society for Gene and Cell Therapy Virtual Congress
detailing analysis methods for liver transduction and expression in
non-human primate liver after AAVS3 delivery and the Company's
second generation two-plasmid packaging system for AAV vectors to
improve quality and yield.
Corporate
-- Today the Company announced the expansion and strengthening
of its executive leadership team with the appointment of Pamela
Foulds, MD as Chief Medical Officer. Dr. Foulds is a US-trained
physician, with over 20 years of experience as a leader in the life
sciences sector and extensive practice in the rare disease field.
She is an experienced CMO, having served in that capacity at both
Auregen BioTherapeutics SA and Aegerion Pharmaceuticals Inc. Prior
to that, she spent eight years at Biogen Inc., working in both
hemophilia and neurology. Earlier in her career, Dr. Foulds oversaw
medical affairs for the lysosomal storage disease programs at
Genzyme. Dr. Foulds will report to Chief Executive Officer Michael
Parini and serve on the executive leadership team. She will be
based in the US leading the Company's global clinical, medical and
regulatory activities. Dr. Foulds holds a Bachelor of Science
degree from Georgetown University and a medical degree from
Georgetown University Medical School. She was trained in Neurology
at Stanford University Hospital.
Q3 2021 Financial Highlights
-- Cash Position: Cash and cash equivalents were $136.4 million
as of September 30, 2021, as compared to $230.0 million as of
December 31, 2020. Based on the Company's revised operating plan,
Freeline expects that its current level of cash and cash
equivalents will enable the Company to fund its operating expenses
into the first quarter of 2023. The Company continues to review its
operations to focus resources on efforts that are expected to
return the highest value to its shareholders.
-- R&D Expenses: Research and development ("R&D")
expenses for the nine months ended September 30, 2021 were $70.8
million, as compared to $55.3 million for the same period in 2020.
The increase of $15.5 million was driven by increased investment in
activities related to the current and proposed clinical trials for
FLT201, facilities and overall R&D, which includes earlier
pipeline programs and further development of Freeline's platform
technology.
-- G&A Expenses: General and administrative ("G&A")
expenses for the nine months ended September 30, 2021 were $37.2
million, as compared to $14.9 million for the same period in 2020.
The increase of $22.3 million was driven primarily by an increase
in legal and professional fees, related to expenses associated with
the Company's status as a public company, including annual and
periodic reporting, implementation of equity compensation programs,
more extensive governance requirements, and increased audit fees
and expenses related to US GAAP requirements, as well as an
increase in non-cash share-based compensation expense, primarily
due to equity grants to employees related to the completion of the
Series C financing and the IPO.
-- As of September 30, 2021, the Company had 35,814,255 ordinary shares issued and outstanding.
About Freeline Therapeutics
Freeline is a clinical-stage biotechnology company developing
transformative adeno-associated virus (AAV) vector-mediated
systemic gene therapies. The Company is dedicated to improving
patient lives through innovative, one-time treatments that provide
functional cures for inherited systemic debilitating diseases.
Freeline uses its proprietary, rationally designed AAV vector,
along with novel promoters and transgenes, to deliver a functional
copy of a therapeutic gene into human liver cells, thereby
expressing a persistent functional level of the missing or
dysfunctional protein into the patient's bloodstream. The Company's
integrated gene therapy platform includes in-house capabilities in
research, clinical development, manufacturing and
commercialization. The Company has clinical programs in hemophilia
B and Fabry disease, as well as preclinical programs in Gaucher
disease Type 1 and hemophilia A. Freeline is headquartered in the
UK and has operations in Germany and the US.
About Hemophilia
Hemophilia is a genetic bleeding disorder caused by a deficiency
in clotting factor protein that impairs blood clot formation. In
hemophilia A, there is a deficiency of the clotting factor VIII
(eight) protein and in hemophilia B, there is a deficiency of the
clotting factor IX (nine) protein. Hemophilia A and B are X-linked
diseases that mainly affect boys and men; however, women who carry
an affected copy of the clotting factor gene may also experience
symptoms. Hemophilia A is the most common type of hemophilia
affecting about one in every 5,000 males, while hemophilia B
affects about one in every 30,000 males. Hemophilia is classified
as mild, moderate or severe, depending on the level of clotting
factor VIII or IX in the blood and is diagnosed through blood
tests.
About FLT180a for Hemophilia B
The Freeline hemophilia B program, FLT180a, uses a potent,
rationally designed capsid (AAVS3) containing an expression
cassette encoding a gain of function Padua variant of human factor
IX (FIX). FLT180a was studied in B-AMAZE, a Phase 1/2 dose-finding
trial in patients with severe and moderately severe hemophilia B
with the goal of normalizing FIX activity in patients with moderate
and severe hemophilia. Patients treated in B-AMAZE are being
followed in a long-term follow-up study. A Phase 1/2
dose-confirmation trial of FLT180a called B-LIEVE is planned.
About Fabry Disease
Fabry disease is a genetic lysosomal disease that leads to a
deficiency in <ALPHA>-galactosidase A (<ALPHA>-Gal A),
which is a key enzyme needed to break down a fatty substance called
globotriaosylceramide (Gb3) and lyso-Gb3. Without the enzyme, this
fatty substance builds up throughout the body, affecting tissues
and organs including skin, kidneys, heart and the nervous system.
Fabry disease occurs in all ethnic groups and is estimated to
affect one in every 40,000 people. Freeline is currently focused on
classic Fabry disease where patients have little to no functional
<ALPHA>-Gal A enzyme. The current standard of care is
lifelong intravenous infusions of enzyme replacement therapy (ERT)
or pharmacological chaperone therapy (PCT). Certain treatments can
carry a significant burden on the patient. The aim of Freeline's
investigational gene therapy program is to deliver a one-time
treatment of a long-lasting gene therapy that will provide a
sustained, therapeutically relevant level of <ALPHA>-Gal A
that we believe would eliminate the need for ERT or PCT.
About FLT190 for Fabry Disease
FLT190 is an investigational AAV gene therapy in development as
a potential treatment for patients with Fabry disease. FLT190
consists of a potent, rationally designed capsid (AAVS3) containing
an expression cassette with a codon-optimized human
<ALPHA>-Gal A cDNA under the control of a liver-specific
promoter. The Company's current MARVEL-1 Phase 1/2 dose-finding
trial evaluates the safety and efficacy of FLT190 in Fabry
patients, who often have pre-existing cardiac manifestations due to
underlying substrate accumulation and disease progression in the
heart. The treatment is administered by intravenous infusion that
lasts approximately one hour and does not require the patient to
undergo stem cell harvest or conditioning with chemotherapy.
About Gaucher Disease
Gaucher disease is a genetic disorder in which a fatty substance
called glucosylceramide accumulates in macrophages in certain
organs due to the lack of functional glucocerebrosidase (GCase).
The disorder is hereditary and presents in various subtypes.
Freeline is currently focused on Gaucher disease Type 1, the most
common type, which impacts the health of many organs of the body
including the spleen, liver, blood system and bones. The current
standard of care is intravenous infusion of ERT every two weeks,
which is a significant treatment burden on the patient.
About FLT201 for Gaucher Disease
FLT201 is an investigational gene therapy for the treatment of
Gaucher disease Type 1. It consists of a potent, rationally
designed AAV capsid (AAVS3) containing an expression cassette that
encodes for a novel glucocerebrosidase variant (GCase(var85) )
under the control of a liver-specific promoter. The GCase(var85)
contains two novel amino acid substitutions to the wild-type human
GCase, which results in a 20-fold increase in GCase half-life at
lysosomal pH conditions, but similar catalytic parameters to those
of wild-type GCase and ERT. The Company's high-transducing AAVS3
capsid advances its goal to address unmet needs for those affected
by Gaucher disease by potentially enabling sustained, endogenous
production of GCase following a one-time intravenous infusion. The
aim of Freeline's investigational gene therapy program is to
deliver a one-time treatment of a long-lasting gene therapy that
will provide a sustained, therapeutically relevant level of
endogenous GCase, thus eliminating the need for ERT.
Forward-Looking Statements
This press release contains statements that constitute "forward
looking statements" as that term is defined in the United States
Private Securities Litigation Reform Act of 1995, including
statements that express the Company's opinions, expectations,
beliefs, plans, objectives, assumptions or projections regarding
future events or future results, in contrast with statements that
reflect historical facts. Examples include, among other topics,
discussion of the Company's strategies, anticipated operating and
financial performance and financial condition; the Company's
expectations regarding its use of cash and cash runway; statements
regarding the initiation, timing, progress and results of the
Company's preclinical studies and clinical trials, including dosing
of a third patient in the Phase 1/2 MARVEL-1 dose-finding clinical
trial of FLT190, commencement of the Phase 1/2 B-LIEVE
dose-confirmation clinical trial of FLT180a and trial site
initiation in the Phase 1/2 dose-finding clinical trial of FLT201
and data readouts from those trials, whether we have identified a
sufficient number of patients to fully enroll the B-LIEVE trial and
completion of pre-clinical studies of FLT210 ; statements regarding
the expected timing of regulatory filings; and manufacturing,
research, pipeline, and clinical trial plans, including anticipated
clinical development milestones for the Company's product
candidates. In some cases, you can identify such forward-looking
statements by terminology such as "anticipate," "intend,"
"believe," "estimate," "plan," "seek," "project" or "expect,"
"may," "will," "would," "could" or "should," the negative of these
terms or similar expressions. Forward-looking statements are based
on management's current beliefs and assumptions and on information
currently available to the Company, and you should not place undue
reliance on such statements. Forward-looking statements are subject
to many risks and uncertainties, including the Company's recurring
losses from operations; the uncertainties inherent in research and
development of the Company's product candidates, including
statements regarding the timing of initiation, completion and the
outcome of clinical studies or trials and related preparatory work
and regulatory review, regulatory submission dates, regulatory
approval dates and/or launch dates, as well as risks associated
with preclinical and clinical data, including the possibility of
unfavorable new preclinical, clinical or safety data and further
analyses of existing preclinical, clinical or safety data; the
Company's ability to design and implement successful clinical
trials for its product candidates; the recent departures of a
number of executive officers of the Company, and the Company's
ability to fill open positions, implement an orderly transition
process and retain key talent; whether the Company's cash resources
will be sufficient to fund the Company's foreseeable and
unforeseeable operating expenses and capital expenditure
requirements for the Company's expected timeline; the potential for
a pandemic, epidemic or outbreak of infectious diseases in the US,
UK or EU, including the COVID-19 pandemic, to disrupt and delay the
Company's clinical trial pipeline; the Company's failure to
demonstrate the safety and efficacy of its product candidates; the
fact that results obtained in earlier stage clinical testing may
not be indicative of results in future clinical trials; the
Company's ability to enroll patients in clinical trials for its
product candidates; the possibility that one or more of the
Company's product candidates may cause serious adverse, undesirable
or unacceptable side effects or have other properties that could
delay or prevent their regulatory approval or limit their
commercial potential; the Company's ability to obtain and maintain
regulatory approval of its product candidates; the Company's
limited manufacturing experience, which could result in delays in
the development, regulatory approval or commercialization of its
product candidates; and the Company's ability to identify or
discover additional product candidates, or failure to capitalize on
programs or product candidates. Such risks and uncertainties may
cause the statements to be inaccurate and readers are cautioned not
to place undue reliance on such statements. We cannot guarantee
that any forward-looking statement will be realized. Should known
or unknown risks or uncertainties materialize or should underlying
assumptions prove inaccurate, actual results could vary materially
from past results and those anticipated, estimated or projected.
Investors are cautioned not to put undue reliance on
forward-looking statements. A further list and description of
risks, uncertainties and other matters can be found in the
Company's Annual Report on Form 20-F for the fiscal year ended
December 31, 2020 and in subsequent reports on Form 6-K, in each
case including in the sections thereof captioned "Cautionary
Statement Regarding Forward-Looking Statements" and "Item 3.D. Risk
factors." Many of these risks are outside of the Company's control
and could cause its actual results to differ materially from those
it thought would occur. The forward-looking statements included in
this press release are made only as of the date hereof. The Company
does not undertake, and specifically declines, any obligation to
update any such statements or to publicly announce the results of
any revisions to any such statements to reflect future events or
developments, except as required by law. For further information,
please reference the Company's reports and documents filed with the
U.S. Securities and Exchange Commission (the "SEC"). You may review
these documents by visiting EDGAR on the SEC website at www.sec.gov
.
Contact
David S. Arrington
Vice President Investor Relations & Corporate
Communications
Freeline Therapeutics
david.arrington@freeline.life
+1 (646) 668 6947
Freeline Therapeutics Holdings plc
Unaudited Condensed Consolidated Statements of Operations
Data
(in thousands of U.S. dollars, except per share data)
For the Nine Months Ended
September 30,
---------------------------------------------------------------------
2021 2020
-------------------------------- -----------------------------------
OPERATING EXPENSES:
Research and development $ 70,827 $ 55,267
General and administrative 37,219 14,923
Total operating expenses 108,046 70,190
-------------------------------- -----------------------------------
LOSS FROM OPERATIONS: (108,046) (70,190)
OTHER INCOME (EXPENSE) NET:
Other income (expense), net 493 748
Interest income, net 350 144
Benefit from R&D tax credit 1,541 11,127
-------------------------------- -----------------------------------
Total other income (expense),
net 2,384 12,019
-------------------------------- -----------------------------------
Loss before income taxes (105,662) (58,171)
Income tax expense (29) (74)
-------------------------------- -----------------------------------
Net loss (105,691) (58,245)
================================ ===================================
Net loss per share attributable
to ordinary
shareholders-basic and diluted $ (2.96) $ (8.39)
================================ ===================================
Weighted average ordinary shares
outstanding-basic
and diluted 35,686,751 6,940,608
================================ ===================================
Freeline Therapeutics Holdings plc
Unaudited Condensed Consolidated Balance Sheet Data
(in thousands of U.S. dollars, except per share data)
September
30, December 31,
----------------------------- -----------------------------
2021 2020
----------------------------- -----------------------------
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 136,377 $ 229,974
Account receivable - 97
Prepaid expenses and other current assets 22,161 28,105
----------------------------- -----------------------------
Total current assets 158,538 258,176
Property and equipment, net 10,141 8,608
Intangible assets, net 10 23
Other non-current assets 2,077 1,805
Total assets $ 170,766 $ 268,612
============================= =============================
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 5,665 $ 8,093
Accrued expenses and other current liabilities 12,303 10,719
Total current liabilities 17,968 18,812
----------------------------- -----------------------------
Total liabilities 17,968 18,812
============================= =============================
Commitments and contingencies
SHAREHOLDERS' EQUITY:
Deferred shares 137 155
Additional paid-in capital 465,285 456,293
Accumulated other comprehensive loss 9,057 9,342
Accumulated deficit (321,681) (215,990)
----------------------------- -----------------------------
Total shareholders' equity 152,798 249,800
TOTAL LIABILITIES AND SHAREHOLDERS'
EQUITY $ 170,766 $ 268,612
============================= =============================
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
PFUKKLFBFFLZFBK
(END) Dow Jones Newswires
November 10, 2021 02:00 ET (07:00 GMT)
Syncona (LSE:SYNC)
Gráfica de Acción Histórica
De Mar 2024 a Abr 2024
Syncona (LSE:SYNC)
Gráfica de Acción Histórica
De Abr 2023 a Abr 2024