Freeline Reports First Quarter 2023 Financial Results and Business Highlights
30 5월 2023 - 8:30PM
Freeline Therapeutics Holdings plc (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
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 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 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.
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
Aokinaomi.aoki@freeline.lifeSenior Vice President, Head of
Investor Relations & Communications+ 1 617 283 4298
Freeline Therapeutics (NASDAQ:FRLN)
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