REG - Syncona Limited - Freeline reports Q1 2022 Financial Results

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11/05/2022 07:00

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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/ (http://www.freeline.life/investors/) and the
full text of the announcement from Freeline is contained below.

  ENDS 

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 (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,
                                                         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                      (0.63       )                          (0.98       )

    shareholders-basic and diluted
 Weighted average ordinary shares outstanding-basic               42,644,340                             35,655,443

    and diluted

 

 

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 (mailto:arne.naeveke@freeline.life)

+1 617 312 2521

IR Contact:

 

investor@freeline.life

 

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