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RNS Number : 0197L
Syncona Limited
11 May 2022
Syncona Limited
Freeline reports Q1 2022 Financial Results and Business
Highlights
11 May 2022
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 Plc
(NASDAQ: FRLN) ("Freeline"), announced its operational and
financial results for the first quarter ended March 31, 2022.
The announcement can be accessed on Freeline's website at:
www.freeline.life/investors/ and the full text of the announcement
from Freeline is contained below.
[S]
Enquiries
Syncona Ltd
Natalie Garland-Collins / Fergus Witt
Tel: +44 (0) 7714 916615
FTI Consulting
Ben Atwell / Julia Bradshaw / 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 First Quarter 2022 Financial Results and
Business Highlights
Phase 1/2 clinical programs in Hemophilia B, Gaucher disease and
Fabry disease
on track to deliver 2022 milestones
Recent appointment of new Chief Financial Officer further
strengthens leadership team
LONDON, May 10, 2022 - Freeline Therapeutics Holdings plc
(Nasdaq: FRLN) (the "Company" or "Freeline") today reported
financial results for the first quarter of 2022 and provided a
business update.
"We continue the transformation of Freeline to unlock its
untapped value, focusing on executing our clinical programs with
urgency, demonstrating financial discipline and operational
excellence in our business and developing our new R&D strategy
to explore the application of our science and platform technologies
to new disease areas," said Michael Parini, Chief Executive Officer
of Freeline. "Following a successful equity offering in March, we
are leveraging our strengthened balance sheet to advance all three
clinical programs and deliver their 2022 milestones. The addition
of Paul Schneider as Freeline's new Chief Financial Officer further
strengthens our highly experienced leadership team. We are excited
and confident about continuing our evolution as a company in the
second half of the year."
Key Clinical Program Updates
FLT180a in Hemophilia B - On track to fully enroll Phase 1/2
B-LIEVE dose confirmation trial by the end of the third quarter of
2022, which would enable pivotal Phase 3 start-up activities in the
first half of 2023.
-- The trial is currently underway to confirm the 7.7e11 vg/kg
dose and prophylactic immune management to be used in the pivotal
Phase 3 study.
-- The first cohort was completed in April 2022 following the
dosing of the first patient in March 2022. Reporting of initial
data from the first cohort is expected in the first half of
2022.
-- FLT180a is positioned to be a best-in-class gene therapy
candidate with the potential to provide a functional cure through
durable and predictable normalization of Factor IX activity as
demonstrated in the long-term follow-up study of the Phase 1/2
dose-finding trial, B-AMAZE.
-- In market research, physicians ranked predictable and durable
Factor IX levels in the normal range as the preferred attributes of
an AAV gene therapy so that eligible patients can be free of
bleeds.
FLT190 in Fabry Disease - Updated clinical development plan and
timelines for Phase 1/2 MARVEL-1 trial accelerated dose escalation
to mid-year 2022.
-- The Company has proceeded to the second dose cohort (1.5e12
vg/kg) with dosing expected by mid-2022.
-- This acceleration occurred following a comprehensive review
of the pre-clinical data and the efficacy and safety data generated
to date in the MARVEL-1 trial with the study's independent Data
Monitoring Committee in March 2022.
-- The Company expects to provide a program update in the second half of 2022.
FLT201 in Gaucher Disease - On track to initiate dosing in
first-in-human, Phase 1/2 GALILEO-1 adaptive dose escalation trial
in the first half of 2022.
-- The Company expects to complete dosing of the first cohort by
mid-2022 and complete the second cohort in the second half of 2022,
with initial data expected in the second half of the year.
-- GALILEO-1 will identify a dose of FLT201 with prophylactic
immune management for a pivotal Phase 3 trial in adults with
Gaucher disease Type 1. The prophylactic immune management regimen
is the same as for FLT180a in Hemophilia B and FLT190 in Fabry
disease.
Key Corporate Updates
Continued strengthening of leadership team
Following the appointment of Henning Stennicke, PhD, as Chief
Scientific Officer in March 2022, Paul Schneider will be joining
Freeline as its new Chief Financial Officer on May 16, 2022, as
announced in April 2022.
Q1 2022 Financial Highlights
1. Cash Position: Cash and cash equivalents were $113.1 million
as of March 31, 2022, as compared to $117.7 million as of year-end
2021. On March 15, 2022, Freeline closed a $26.1 million registered
direct offering with certain long-term shareholders. The proceeds
will support the advancement of Freeline's clinical-stage programs
and the extension of the Company's scientific capabilities and
platform technologies to additional disease areas. Freeline expects
that its current level of cash and cash equivalents will enable the
Company to fund its operating expenses into the second half of
2023.
2. Research and Development ("R&D") Expenses: R&D
expenses for the three months ended March 31, 2022 were $19.9
million, as compared to $23.9 million for the same period in 2021.
The decrease of $3.9 million was driven by decreases in spending
related to FLT210, our former product candidate for the treatment
of Hemophilia A, FLT180a and FLT201, as well as in personnel
expenses and non-cash share-based compensation expense. These
decreases were partially offset by an increase in spending related
to other expenses, mainly due to increases in facility-related
expenses and CMO fees and in spending related to FLT190, which is
primarily related to higher clinical trial costs for the ongoing
Phase 1/2 MARVEL-1 clinical trial in 2022.
3. General and Administrative ("G&A") Expenses: G&A
expenses for the three months ended March 31, 2022 were $8.2
million, as compared to $10.1 million for the same period in 2021.
The decrease of $1.9 million was driven by decreases in legal and
professional fees, non-cash share-based compensation expense,
facilities and other expenses resulting from a decrease in D&O
insurance expense. The decreases were partially offset by a slight
increase in personnel expenses, primarily related to personnel
hired in corporate, general and administrative functions.
4. As of March 31, 2022, the Company had 62,345,313 ordinary shares outstanding.
About Freeline Therapeutics
Freeline is a clinical-stage biotechnology company developing
transformative adeno-associated virus 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 and commercialization. The Company has
clinical programs in Hemophilia B, Fabry disease, and Gaucher
disease Type 1. Freeline is headquartered in the UK and has
operations in Germany and the U.S.
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. All statements, other than historical
facts, including statements regarding the potential of FLT180a to
provide a functional cure through durable and predictable
normalization of Factor IX activity and to be positioned as a
best-in-class gene therapy, the timing of initiation, enrollment,
continuation, completion and the outcome of clinical trials and
related preparatory work, including full enrollment of the Phase
1/2 B-LIEVE dose-confirmation clinical trial of FLT180a, the timing
of start-up activities for the pivotal Phase 3 clinical trial of
FLT180a, dosing of the second dose cohort in the Phase 1/2 MARVEL-1
dose-finding clinical trial of FLT190, and dosing in the Phase 1/2
dose-finding clinical trial of FLT201 and data readouts from such
trials, the use of the proceeds from the registered direct
offering, and the Company's expectations regarding its use of cash
and cash runway, are forward-looking statements. In some cases, you
can identify such forward-looking statements by terminology such as
"anticipate," "intend," "believe," "estimate," "plan," "seek,"
"project" "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, enrollment,
continuation, 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 United States, United Kingdom or
European Union, 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;
business interruptions resulting from geopolitical actions,
including global hostilities, war and terrorism, global pandemics
or natural disasters, including earthquakes, typhoons, floods and
fires; 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 history, 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. The Company 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, 2021, 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
.
Unaudited Condensed Consolidated Statement of Operations
Data
(in thousands of U.S. dollars, except per share data)
For the Three Months Ended March 31,
------------------------------------------
2022 2021
-------------------- ----------------
OPERATING EXPENSES:
Research and development $ 19,948 $ 23,863
General and administrative 8,223 10,078
---------------- ---------------
Total operating expenses 28,171 33,941
---------------- ---------------
LOSS FROM OPERATIONS: (28,171) (33,941)
OTHER INCOME (EXPENSE), NET:
Other income (expense), net 990 (1,733)
Interest income, net 84 140
Benefit from R&D tax credit 386 598
---------------- ---------------
Total other income (expense), net 1,460 (995)
---------------- ---------------
Loss before income taxes (26,711) (34,936)
Income tax expense (22) (9)
---------------- ---------------
Net loss $ (26,733) $ (34,945)
---------------- ---------------
Net loss per share attributable to ordinary
shareholders-basic and diluted (0.63) (0.98)
================ ===============
Weighted average ordinary shares outstanding-basic
and diluted 42,644,340 35,655,443
================ ===============
Unaudited Condensed Consolidated Balance Sheet Data
(in thousands of U.S. dollars)
March 31, December 31,
--------- --------------
2022 2021
--------- --------------
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 113,098 $ 117,662
Prepaid expenses and other current assets 9,251 10,630
-------- ----------
Total current assets 122,349 128,292
NON-CURRENT ASSETS:
Property and equipment, net 9,635 9,906
Intangible assets, net 6 8
Operating lease right of use assets 60,055 -
Other non-current assets 4,128 2,919
-------- ----------
Total assets $ 196,173 $ 141,125
======== ==========
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 9,141 $ 5,187
Accrued expenses and other current liabilities 8,841 15,497
Operating lease liabilities, current 7,412 -
-------- ----------
Total current liabilities 25,394 20,684
-------- ----------
NON-CURRENT LIABILITIES:
Operating lease liabilities, non-current 52,217 -
-------- ----------
Total liabilities $ 77,611 $ 20,684
======== ==========
Commitments and contingencies (Note 9)
SHAREHOLDERS' EQUITY:
Deferred shares 137 137
Additional paid-in capital 494,797 467,213
Accumulated other comprehensive gain 6,742 9,472
Accumulated deficit (383,114) (356,381)
-------- ----------
Total shareholders' equity 118,562 120,441
-------- ----------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 196,173 $ 141,125
======== ==========
Media Contact:
Arne Naeveke, PhD
Vice President, Head of Corporate Communications
arne.naeveke@freeline.life
+1 617 312 2521
IR Contact:
investor@freeline.life
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