REG - Syncona Limited - Freeline reports Q2 2023 Financial Results

SynconaAnnouncement

15/08/2023 12:15

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RNS Number : 3729J  Syncona Limited  15 August 2023

Syncona Limited

Freeline reports Q2 2023 Financial Results and Business Highlights

15 August 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 financial results and a corporate update for the
second quarter ended June 30, 2023.

Key highlights include:

·      Announced completion of dosing in the first dose cohort of the
Phase I/II trial of FLT201 in Gaucher disease, following dosing of the second
patient

·      Initial clinical data from the FLT201 trial is expected in the
second half of CY2023

·      Unveiled research programme in Parkinson's disease in June,
leveraging technology from the FLT201 programme to develop a gene therapy
candidate for a subset of Parkinson's disease patients with mutations in the
GBA1 gene 1 

·      Cash position of $38.8 million, which Freeline expects 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. Management
will also be hosting a conference call at 08:00 am ET / 1:00 pm BST today, to
discuss the results.

  ENDS 

Enquiries

Syncona Ltd

Annabel Clark / Fergus Witt

Tel: +44 (0) 20 3981 7940

 

FTI Consulting

Ben Atwell / Natalie Garland-Collins / 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 Second Quarter 2023 Financial Results and Business Highlights

Completed dosing in first cohort of Phase 1/2 GALILEO-1 trial of FLT201 in
Gaucher disease; expect to report initial clinical data in third quarter of
2023

Extending impact of its novel GCase variant with research program for
GBA1-linked Parkinson's disease

Management to host conference call at 8:00 a.m. ET today

 

LONDON, August 15, 2023 - Freeline Therapeutics Holdings plc
(http://www.freeline.life/) (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 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 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 (https://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 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
(http://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         $       (0.23       )               $       (0.95       )

   shareholders-basic and diluted
 Weighted average ordinary shares outstanding-basic          65,140,334                          53,587,167

   and diluted

 

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 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  As in Gaucher disease, GBA1 mutations lead to a deficiency of the GCase
enzyme, and increase the risk of developing Parkinson's disease by up to
30-fold

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