REG - Syncona Limited - Freeline reports Q1 2023 Financial Results
30/05/2023 12:45
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RNS Number : 0461B Syncona Limited 30 May 2023
Syncona Limited
Freeline reports Q1 2023 Financial Results and Corporate Update
30 May 2023
Syncona Ltd, a leading healthcare company focused on creating, building and
scaling a portfolio of global leaders in life science, notes that its
portfolio company, Freeline Therapeutics Holdings plc (Nasdaq: FRLN)
("Freeline"), announced its first quarter results and a corporate update for
the full year ended December 31, 2023.
Key highlights include:
· Company expects to report initial data from its FLT201 trial in
Gaucher disease in the second half of CY2023. Syncona continues to believe in
the potential for the Gaucher programme to be a first- and best-in-class
therapy for patients with Gaucher disease type 1 1 (#_ftn1)
· FLT201 has been granted an Innovation Passport for the treatment of
Gaucher disease type 1 under the Innovative Licensing and Access Pathway
(ILAP) by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA).
This is the first step in the ILAP process, which aims to accelerate time to
market for life-threatening or seriously debilitating conditions
· The company has regained compliance with the Nasdaq minimum bid
price requirement, and will continue to be traded on the Nasdaq Capital Market
under the ticker symbol FRLN. This follows completion of the change of its
American Depositary Share ("ADS") to ordinary share ratio from one ADS to one
ordinary share to the new ratio of one ADS to fifteen ordinary shares
· Freeline expects that its current level of cash and cash equivalents
will enable the company to fund its planned operations into the second quarter
of 2024
The announcement can be accessed on Freeline's website at:
www.freeline.life/investors/ (http://www.freeline.life/investors/) and the
full text of the announcement from Freeline is contained below.
ENDS
Enquiries
Syncona Ltd
Annabel Clark / Fergus Witt
Tel: +44 (0) 20 3981 7940
FTI Consulting
Ben Atwell / Natalie Garland-Collins / 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
creating 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 create, build and scale companies around exceptional
science to create a diversified portfolio of 20-25 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 2023 Financial Results and Business Highlights
Expect to report initial clinical data for FLT201 in Gaucher disease in third
quarter of 2023
FLT201 granted ILAP designation, which aims to accelerate time to market and
facilitate patient access in the UK for medicines that address significant
unmet needs
Regained compliance with Nasdaq listing requirements
LONDON, May 30, 2023 - Freeline Therapeutics Holdings plc
(http://www.freeline.life) (Nasdaq: FRLN) today reported financial results for
the first quarter of 2023 and provided a business update.
"FLT201 is a potential first- and best-in-class gene therapy for people with
Gaucher disease, potentially improving clinical outcomes with a one-time
treatment," said Michael Parini, Freeline's Chief Executive Officer. "The
granting of the ILAP designation by UK regulators further highlights the
significant need for more effective and less burdensome therapies for people
with Gaucher disease. Advancing FLT201 toward initial clinical data is our
greatest near-term strategic imperative, and we expect to deliver meaningful
safety and enzyme data from the first cohort of the GALILEO-1 Phase 1/2 trial
in the third quarter of this year.
"Importantly, we continue to make significant strides as a company in driving
greater focus, financial discipline, and operational efficiency," Parini
continued. "Over the past year, we have prioritized the clinical portfolio,
streamlined the organization, and reduced operating costs by approximately 30
percent. Our first quarter results reflect our commitment to focus on what we
believe will provide the greatest benefit for patients and drive the greatest
value for Freeline and its shareholders."
Anticipated Clinical Data for FLT201
· Report initial data, including assessments of safety and enzyme
activity, from the first cohort of the GALILEO-1 trial of FLT201 in Gaucher
disease in the third quarter of 2023.
Recent Corporate Highlights
· Freeline received notice on May 26 from The Nasdaq Stock Market LLC
(Nasdaq) informing the company that it has regained compliance with the Nasdaq
minimum bid price requirement. The company is now in compliance with all
applicable listing standards and its American Depositary Shares will continue
to be traded on the Nasdaq Capital Market under the ticker symbol FRLN.
· Freeline also announced that it has entered into a favorable mutual
release and settlement agreement with Brammer Bio MA, LLC to resolve the
arbitration arising from the Dedicated Manufacturing and Commercial Supply
Agreement. Pursuant to the terms of the settlement agreement, Freeline paid
Brammer $2.25 million and no longer has any ongoing or future obligations to
Brammer.
· Earlier this month, FLT201 was granted an Innovation Passport for the
treatment of Gaucher disease type 1 under the Innovative Licensing and Access
Pathway (ILAP) by the U.K. Medicines and Healthcare Products Regulatory Agency
(MHRA). The Innovation Passport is the first step in the ILAP process, which
aims to accelerate time to market and facilitate patient access to medicines
in the UK for life-threatening or seriously debilitating conditions, or
conditions for which there is a significant patient or public health need.
Q1 2023 Financial Results
· Cash position: As of March 31, 2023, unrestricted cash and cash
equivalents were $55.4 million, compared to $47.3 million as of December 31,
2022. The $8.1 million net increase was primarily driven by the closing of the
previously announced sale of the company's CMC-focused German subsidiary,
Freeline Therapeutics GmbH, and certain related intellectual property to
Ascend Gene and Cell Therapies Ltd. Freeline expects that its current level of
cash and cash equivalents will enable the company to fund its planned
operations into the second quarter of 2024.
· Total operating expenses: Total operating expenses for the three
months ended March 31, 2023 were $20.1 million, compared to $28.2 million for
the same period in 2022. The decrease in total operating expenses of $8.1
million was primarily attributable to a decrease in expenditures related to
the company's deprioritized FLT180a and FLT190 programs, including CMC costs,
and reduced headcount-related costs, including share-based compensation
expense. These decreases were partially offset by a one-time restructuring
charge of $1.1 million and $2.2 million in fees associated with the sale of
the company's German subsidiary.
· Net income: Net income was $1.2 million, or $0.02 per basic and
diluted share, for the first three months ended March 31, 2023, as compared to
a net loss of $26.7 million, or $0.63 per basic and diluted share in the same
period in 2022.
About Freeline Therapeutics
Freeline is a clinical-stage biotechnology company focused on developing
transformative gene therapies for chronic debilitating diseases. Freeline
uses its proprietary, rationally designed AAV vector and capsid (AAVS3), 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 a patient's
bloodstream. The company is currently advancing FLT201, a highly
differentiated gene therapy candidate that delivers a novel transgene, in a
Phase 1/2 clinical trial in people with Gaucher disease type 1. Freeline is
headquartered in the UK and has operations in the United States. For more
information, visit www.freeline.life (http://www.freeline.life) or connect
with Freeline on LinkedIn (https://www.linkedin.com/company/freelinelife)
and Twitter (https://twitter.com/FreelineLife) .
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 opinions,
expectations, beliefs, plans, objectives, assumptions or projections
of Freeline Therapeutics Holdings plc (the "Company") regarding future
events or future results, in contrast with statements that reflect historical
facts. Examples include, among other topics, statements regarding the
Company's strategies, anticipated operating and financial performance and
financial condition; the potential of FLT201 to be a first- and best-in-class
gene therapy for Gaucher disease and change the lives of and improve clinical
outcomes for people with Gaucher disease type 1 with a one-time therapy, the
Company's expectations regarding its use of cash and cash runway; and the
timing of data readouts from the Company's GALILEO-1 Phase 1/2 clinical
trial. 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,
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; 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 in light of management's substantial doubt
regarding the Company's ability to continue as a going concern for at least 12
months from the issuance date of this press release; 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 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, 2022, 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
(http://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,
2023 2022
OPERATING EXPENSES:
Research and development $ 10,893 $ 19,948
General and administrative 8,052 8,223
Restructuring expense 1,137 -
Total operating expenses 20,082 28,171
LOSS FROM OPERATIONS: (20,082) (28,171)
OTHER INCOME (EXPENSE) NET:
Gain on sale of Freeline Therapeutics GmbH 20,279 -
Other income, net 664 990
Interest income, net 206 84
Benefit from R&D tax credit 261 386
Total other income, net 21,410 1,460
Net income (loss) before income taxes 1,328 (26,711)
Income tax expense (162) (22)
Net income (loss) $ 1,166 $ (26,733)
Net income (loss) per share:
Basic 0.02 (0.63)
Diluted 0.02 (0.63)
Weighted average ordinary shares outstanding:
Basic 65,130,907 42,644,340
Diluted 65,763,794 42,644,340
Unaudited Condensed Consolidated Balance Sheet Data
(in thousands of U.S. dollars)
March 31, December 31,
2023 2022
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 55,415 $ 47,279
Prepaid expenses and other current assets 8,454 6,235
Assets held for sale - 14,113
Total current assets 63,869 67,627
NON-CURRENT ASSETS:
Property and equipment, net 9,347 9,007
Operating lease right of use assets 5,435 6,014
Other non-current assets 2,715 3,993
Total assets $ 81,366 $ 86,641
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 12,453 $ 10,058
Accrued expenses and other current liabilities 7,538 7,908
Operating lease liabilities, current 2,750 2,663
Liabilities related to assets held for sale - 10,337
Total current liabilities 22,741 30,966
NON-CURRENT LIABILITIES:
Operating lease liabilities, non-current 2,639 3,261
Total liabilities $ 25,380 $ 34,227
SHAREHOLDERS' EQUITY:
Deferred shares 137 137
Additional paid-in capital 501,754 500,781
Accumulated other comprehensive gain (1,718) (3,151)
Accumulated deficit (444,187) (445,353)
Total shareholders' equity 55,986 52,414
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 81,366 $ 86,641
Media and Investor Contact:
Naomi Aoki
naomi.aoki@freeline.life
(https://www.globenewswire.com/Tracker?data=Jh6c5xik4HX6bIPQmuUSzZCihZ0wTWzpMGf5QyRgE15WUwozv2VznhRHMdPJmyQuP-EdxpTxM3qQ-X_oDYhkk0dUyi1jW2bihv5PFDbtSL4=)
Senior Vice President, Head of Investor Relations & Communications
+ 1 617 283 4298
1 (#_ftnref1) The most common type of Gaucher disease with ~18k patients in
established markets (US, UK, EU4, Israel)
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