Freeline Reports Second Quarter 2023 Financial Results and Business Highlights
15 August 2023 - 1:00PM
Freeline Therapeutics Holdings plc (Nasdaq: FRLN) today reported
financial results for the second quarter of 2023 and provided a
business update.
“FLT201 is a potential first- and best-in-class gene therapy for
Gaucher disease Type 1, the most common type of the disease,” said
Michael Parini, Chief Executive Officer of Freeline. “Advancing the
program is our top strategic priority, and we are extremely pleased
with our recent progress and the momentum in the trial. The
completion of dosing in the first cohort of our GALILEO-1 trial of
FLT201 represents a significant milestone for the program, for
Freeline and for the Gaucher community. We believe FLT201 has the
opportunity to dramatically reduce the disease and treatment burden
for people with Gaucher disease. We look forward to reporting
initial clinical data in the third quarter of this year.”
“In the second quarter, we also unveiled our lead research
program in GBA1-linked Parkinson’s disease, which leverages the
same longer-acting GCase variant as FLT201,” Parini continued. “As
in Gaucher disease, GBA1 mutations lead to a deficiency of the
GCase enzyme and an accumulation of pathological substrates.
Approximately 200,000 people with Parkinson’s disease in the US, UK
and four major European markets have GBA1 mutations, making it the
most common genetic risk factor for the disease. Our GBA1-linked
Parkinson’s disease program is a natural extension of our work in
Gaucher and an opportunity to extend the therapeutic potential of
our longer-acting GCase variant into a genetically defined patient
population with a serious unmet need.”
Anticipated Clinical Data for FLT201
- Initial clinical data, with a focus on assessments of safety
and enzyme activity, from the first cohort of the GALILEO-1 Phase
1/2 trial of FLT201 is expected in the third quarter of 2023.
GALILEO-1 is a first-in-human, international, multicenter Phase 1/2
dose-finding study assessing the safety, tolerability, and efficacy
of a single intravenous dose of FLT201, the company’s
adeno-associated virus (AAV) gene therapy candidate for Gaucher
disease Type 1.
Recent Corporate Highlights
- Today, Freeline announced the dosing of the second patient in
its GALILEO-1 trial of FLT201, marking the completion of dosing in
the first cohort.
- In June, the company announced the dosing of the first patient
in its GALILEO-1 trial.
- Also in June, Freeline unveiled its research program in
GBA1-linked Parkinson’s disease. The program builds on its work in
Gaucher disease, leveraging the same rationally engineered
longer-acting GCase variant as used in FLT201 to develop a gene
therapy candidate for a subset of Parkinson’s disease patients with
mutations in the GBA1 gene. In preclinical studies, Freeline’s
GCase variant has demonstrated at least 20-fold greater activity
levels compared to wildtype enzyme in various cell lines, including
brain epithelial and neuroblastoma cells.
Q2 2023 Financial Results
- Cash Position: As of June 30, 2023,
unrestricted cash and cash equivalents were $38.8 million, compared
to $55.4 million as of March 31, 2023. Freeline expects its current
level of cash and cash equivalents will enable the company to fund
its planned operations into the second quarter of 2024.
- Research and Development (R&D)
Expenses: R&D expenses were $19.7 million for the
six months ended June 30, 2023, as compared to $38.8 million for
the same period in 2022. The $19.1 million decrease was primarily
attributable to a decrease in expenditures related to the company’s
deprioritized FLT180a and FLT190 programs, including CMC costs and
capacity fees, and reduced headcount-related costs, including
share-based compensation expense.
- General and Administrative (G&A) Expenses:
G&A expenses for the six months ended June 30, 2023, were $17.6
million, as compared to $16.3 million for the same period in 2022.
The increase of $1.3 million was driven by $2.2 million in costs
associated with the sale of Freeline Therapeutics GmbH and $2.0
million associated with the ADS depositary fees in connection with
the ADS ratio change. These increases were offset by reduced
G&A headcount-related costs, including share-based compensation
expense.
- Gain on Settlement Agreement: The
company recorded a gain of $2.2 million due to the mutual release
and settlement agreement with Brammer Bio MA, LLC announced in May,
which included the release of approximately $4.5 million of
discharged net liabilities offset by a settlement payment of $2.3
million.
- Net Loss: Net loss was $14.8 million, or $0.23
per ordinary share, for the six months ended June 30, 2023, as
compared to a net loss of $51.1 million, or $0.95 per ordinary
share, in the same period in 2022.
About Freeline TherapeuticsFreeline 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 has
additional programs in research, including one focused on
GBA1-linked Parkinson’s disease that leverages the same novel
transgene as FLT201. Freeline is headquartered in the UK and has
operations in the United States. For more information, visit
www.freeline.life or connect with Freeline on LinkedIn and
Twitter.
Forward-Looking StatementsThis 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 results, in
contrast with statements that reflect historical
facts. Examples include, among other topics, statements
regarding the potential of FLT201 to be a first- and best-in-class
gene therapy for Gaucher disease; the opportunity to extend the
therapeutic potential of the Company’s longer-acting GCase variant
into a genetically defined patient population with a serious unmet
need; 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 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 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. 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.
Unaudited Condensed Consolidated Statements of
Operations(in thousands of U.S. dollars, except per share
data) |
|
|
For the Six Months Ended June 30, |
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
|
License revenue |
$ |
617 |
|
|
$ |
— |
|
OPERATING EXPENSES: |
|
|
|
|
|
Research and development |
|
19,720 |
|
|
|
38,785 |
|
General and administrative |
|
17,581 |
|
|
|
16,278 |
|
Gain on legal settlement |
|
(2,227 |
) |
|
|
— |
|
Restructuring expense |
|
1,276 |
|
|
|
— |
|
Total operating expenses |
|
36,350 |
|
|
|
55,063 |
|
LOSS FROM OPERATIONS: |
|
(35,733 |
) |
|
|
(55,063 |
) |
OTHER INCOME (EXPENSE)
NET: |
|
|
|
|
|
Gain on sale of Freeline Therapeutics GmbH |
|
20,279 |
|
|
|
— |
|
Other (expense) income, net |
|
73 |
|
|
|
2,973 |
|
Interest income, net |
|
240 |
|
|
|
335 |
|
Benefit from R&D tax credit |
|
464 |
|
|
|
721 |
|
Total other income, net |
|
21,056 |
|
|
|
4,029 |
|
Net loss before income
taxes |
|
(14,677 |
) |
|
|
(51,034 |
) |
Income tax expense |
|
(168 |
) |
|
|
(46 |
) |
Net loss |
$ |
(14,845 |
) |
|
$ |
(51,080 |
) |
Net loss per share
attributable to ordinary shareholders—basic and diluted |
$ |
(0.23 |
) |
|
$ |
(0.95 |
) |
Weighted average ordinary
shares outstanding—basic and diluted |
|
65,140,334 |
|
|
|
53,587,167 |
|
|
Unaudited Condensed Consolidated Balance Sheets(in
thousands of U.S. Dollars) |
|
|
June 30, |
|
|
December 31, |
|
|
2023 |
|
|
2022 |
|
ASSETS |
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
Cash and cash equivalents |
$ |
38,797 |
|
|
$ |
47,279 |
|
License receivable |
|
631 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
6,385 |
|
|
|
6,235 |
|
Assets held for sale |
|
— |
|
|
|
14,113 |
|
Total current assets |
|
45,813 |
|
|
|
67,627 |
|
NON-CURRENT ASSETS: |
|
|
|
|
|
Property and equipment, net |
|
9,284 |
|
|
|
9,007 |
|
Operating lease right of use assets |
|
4,792 |
|
|
|
6,014 |
|
Other non-current assets |
|
2,764 |
|
|
|
3,993 |
|
Total assets |
$ |
62,653 |
|
|
$ |
86,641 |
|
LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
Accounts payable |
$ |
6,875 |
|
|
$ |
10,058 |
|
Accrued expenses and other current liabilities |
|
8,963 |
|
|
|
7,908 |
|
Operating lease liabilities, current |
|
2,842 |
|
|
|
2,663 |
|
Liabilities related to assets held for sale |
|
— |
|
|
|
10,337 |
|
Total current liabilities |
|
18,680 |
|
|
|
30,966 |
|
NON-CURRENT LIABILITIES: |
|
|
|
|
|
Operating lease liabilities, non-current |
|
1,957 |
|
|
|
3,261 |
|
Total liabilities |
|
20,637 |
|
|
|
34,227 |
|
SHAREHOLDERS’ EQUITY: |
|
|
|
|
|
Deferred shares |
|
137 |
|
|
|
137 |
|
Additional paid-in capital |
|
502,861 |
|
|
|
500,781 |
|
Accumulated other comprehensive (loss) gain |
|
(784 |
) |
|
|
(3,151 |
) |
Accumulated deficit |
|
(460,198 |
) |
|
|
(445,353 |
) |
Total shareholders’ equity |
|
42,016 |
|
|
|
52,414 |
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
$ |
62,653 |
|
|
$ |
86,641 |
|
|
Media and Investor Contact:Naomi
Aokinaomi.aoki@freeline.lifeSenior Vice President, Head of
Investor Relations & Communications+ 1 617 283 4298
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