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 teamFollowing 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
- 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.
- 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.
- 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.
- 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, PhDVice President, Head of Corporate
Communicationsarne.naeveke@freeline.life +1 617 312 2521
IR Contact:
investor@freeline.life
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