Silence Therapeutics plc, Nasdaq: SLN (“Silence” or “the
Company”), an experienced and innovative biotechnology company
committed to transforming people’s lives by silencing diseases
through precision engineered medicines, today reported its
financial results for the third quarter ended September 30, 2022
and reviewed recent business highlights.
“Silence’s third quarter was one of strong execution across our
business,” said Craig Tooman, President and Chief Executive Officer
of Silence. “We strengthened our balance sheet in August and made
excellent progress advancing our pipeline programs. We’re looking
forward to initiating the SLN360 phase 2 study in ASCVD and the
SLN124 phase 1/2 study in PV.”
Third Quarter 2022 & Recent Highlights
mRNAi GOLD™ Proprietary Program
Updates
SLN360 (cardiovascular disease)
- Presented a new analysis from the APOLLO phase 1 single dose
study of SLN360 in healthy adults with high lipoprotein(a), a key
genetic risk factor for cardiovascular disease, in a moderated
poster session at the American Heart Association (“AHA”) 2022
Annual Meeting.
- Assessment showed participants who received a single dose of
SLN360 maintained median Lp(a) reductions over 80% over a
five-month period. Additionally, extension data to day 365 showed
no new drug related safety findings.
SLN124 (hematological diseases)
- Reported preliminary single dose results from the GEMINI II
phase 1 study of SLN124 in non-transfusion dependent thalassemia
patients.
- Data showed no serious adverse events (“AEs”), no severe
treatment emergent AEs that were SLN124 related and no TEAEs
leading to withdrawal.
- No dose limiting toxicity or drug related liver injury was
observed.
- Received FDA Fast Track Designation for SLN124 for the
treatment of polycythemia vera (PV).
Anticipated Milestones
- SLN360 phase 2 study in patients with atherosclerotic
cardiovascular disease (“ASCVD”) and high Lp(a) expected to start
in the fourth quarter of 2022.
- SLN124 phase 1/2 study in PV patients expected to start in the
fourth quarter of 2022.
Third Quarter 2022 Financial Results
For the three-month period ending September 30, 2022, the net
loss after tax was £7.1 million, or weighted average loss per share
of 7.2 pence, compared to a loss of £9.9 million, or weighted
average loss per share of 11.1 pence, for the same period in 2021.
For the nine-month period ending September 30, 2022, the net loss
after tax was £26.7 million, or weighted average loss per share of
28.8 pence, compared to £30.0 million, or weighted average loss per
share of 33.8 pence, for the same period in 2021. The decrease in
net loss was primarily related to increase in revenues from our
collaboration agreements as we continue to further advance the
programs.
On August 11, 2022 the Group announced a registered direct
offering (“Offering”) of 5,950,000 of the Company’s ADSs, each
representing three ordinary shares, at a price of $9.50 per ADS,
with new and existing institutional and accredited investors. The
aggregate gross proceeds of the Offering was $56.5 million
(approximately £46.4 million) before deducting $4.1 million
(approximately £3.3 million) in placement agent fees and other
expenses.
Revenue Revenue recognized for the three months period
ending September 30, 2022 grew by £0.2 million to £3.4 million from
£3.2m in the same period in 2021. For the nine-month period ending
September 30, 2022, revenue grew by £3.7 million from £9m in the
same period in 2021. The growth is a result of the further
advancement of the partner programs. During the first nine-months
ended September 30, 2022, two additional milestones for a total of
$5 million were achieved and received.
Cost of sales Cost of sales increased £0.3 million for
the three months ended September 30, 2022, as compared to the same
period in 2021. For the nine months ended September 30, 2022 cost
of sales increased £1.6 million. This was mainly due to increased
activity associated with our collaboration agreements.
Research and Development Research and development
expenditure for the three months ended September 30, 2022 were £8.8
million compared to £7.9 million for the same three month period
ending September 30, 2021. Research and development expenditures
for the nine months ending September 30, 2022 was £27.2 million
(nine months ended September 30,2021: £23.5 million). This was due
to an increase in contracted research and development expenses
resulting from advancement of studies for SLN124 and SLN360.
General and Administrative General and administrative
expenses for the three-month period ended September 30, 2022
increased by £0.4 million to £5.8 million from £5.5 million for the
same corresponding period in 2021. For the nine-month period ended
September 30, 2022, general and administrative expenses increased
£1.5 million as compared to the same period in 2021 primarily due
to the growth of the organization and continued public company
requirements.
Liquidity, cash and cash equivalents As of September 30,
2022, the Company had cash and cash equivalents of £90.0 million
(approximately $113.3 million). In August 2022 the Company raised
additional funds through a registered direct offering with
aggregate gross proceeds of $56.5 million (approximately £46.4
million) before deducting $4.1 million (approximately £3.3 million)
in placement agent fees and other expenses. During the year, the
Company received two financial milestones from our existing
collaboration agreements totaling $5 million.
About Silence Therapeutics Silence Therapeutics is
developing a new generation of medicines by harnessing the body's
natural mechanism of RNA interference, or RNAi, to inhibit the
expression of specific target genes thought to play a role in the
pathology of diseases with significant unmet need. Silence's
proprietary mRNAi GOLD™ platform can be used to create siRNAs
(short interfering RNAs) that precisely target and silence
disease-associated genes in the liver, which represents a
substantial opportunity. Silence's wholly owned product candidates
include SLN360 designed to address the high and prevalent unmet
medical need in reducing cardiovascular risk in people born with
high levels of lipoprotein(a) and SLN124 designed to address rare
hematological diseases. Silence also maintains ongoing research and
development collaborations with AstraZeneca, Mallinckrodt
Pharmaceuticals, and Hansoh Pharma, among others. For more
information, please visit
https://www.silence-therapeutics.com/.
Forward-Looking Statements Certain statements made in
this announcement are forward-looking statements within the meaning
of the U.S. Private Securities Litigation Reform Act of 1995 and
other securities laws, including with respect to the Company’s
clinical and commercial prospects, regulatory approvals of the
Company’s product candidates, potential partnerships or
collaborations or payments under new and existing collaborations,
the initiation or completion of the Company’s clinical trials and
the anticipated timing or outcomes of data reports from the
Company’s clinical trials. These forward-looking statements are not
historical facts but rather are based on the Company's current
assumptions, beliefs, expectations, estimates and projections about
its industry. Words such as 'anticipates,' 'expects,' 'intends,'
'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions
are intended to identify forward-looking statements. These
statements are not guarantees of future performance and are subject
to known and unknown risks, uncertainties, and other factors, some
of which are beyond the Company's control, are difficult to
predict, and could cause actual results to differ materially from
those expressed or forecasted in the forward-looking statements,
including those risks identified in the Company’s most recent
Admission Document and its Annual Report on Form 20-F filed with
the U.S. Securities and Exchange Commission (the “SEC”) on March
17, 2022. The Company cautions security holders and prospective
security holders not to place undue reliance on these
forward-looking statements, which reflect the view of the Company
only as of the date of this announcement. The forward-looking
statements made in this announcement relate only to events as of
the date on which the statements are made. The Company will not
undertake any obligation to release publicly any revisions or
updates to these forward-looking statements to reflect events,
circumstances, or unanticipated events occurring after the date of
this announcement except as required by law or by any appropriate
regulatory authority.
Condensed consolidated income statement (unaudited)
Three months ended
Three months ended
Nine months ended
Nine months ended
September 30, 2022
September 30, 2021
September 30, 2022
September 30, 2021
£000s (except per share information)
'£000s
'£000s
'£000s
'£000s
Revenue
3,371
3,156
12,736
9,001
Cost of sales
(2,394
)
(2,052
)
(7,021
)
(5,414
)
Gross profit
977
1,104
5,715
3,587
Research and development expenses
(8,771
)
(7,916
)
(27,206
)
(23,541
)
General and administrative expenses
(5,827
)
(5,472
)
(16,141
)
(14,597
)
Operating loss
(13,621
)
(12,284
)
(37,632
)
(34,551
)
Finance and other expenses
(34
)
(64
)
(34
)
(86
)
Finance and other income
4,329
296
5,348
8
Loss for the period before
taxation
(9,326
)
(12,052
)
(32,318
)
(34,629
)
Taxation
2,223
2,123
5,592
4,653
Loss for the period after
taxation
(7,103
)
(9,929
)
(26,726
)
(29,976
)
Loss per ordinary equity share (basic
and diluted)
(7.2) pence
(11.1) pence
(28.8) pence
(33.8) pence
Condensed consolidated balance sheet (unaudited)
September 30, 2022
December 31, 2021
£000s
£000s
Non-current assets
Property, plant and equipment
2,319
1,944
Goodwill
7,958
7,592
Other intangible assets
20
24
Financial assets at amortized cost
284
301
10,581
9,861
Current assets
Cash and cash equivalents
90,017
73,537
R&D tax credit receivable
12,966
6,945
Other current assets
10,343
5,520
Trade receivables
130
331
113,456
86,333
Non-current liabilities
Contract liabilities
(63,973
)
(72,501
)
(63,973
)
(72,501
)
Current liabilities
Contract liabilities
(10,624
)
(4,247
)
Trade and other payables
(14,810
)
(10,783
)
Lease liability
(499
)
(137
)
(25,933
)
(15,167
)
Net(liabilities)/assets
34,131
8,526
Capital and reserves attributable to
the owners of the parent
Share capital
5,384
4,489
Capital reserves
276,163
225,462
Translation reserve
2,228
1,541
Accumulated losses
(249,644
)
(222,966
)
Total shareholders
(deficit)/equity
34,131
8,526
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221110005384/en/
Enquiries: Silence Therapeutics plc Gem Hopkins,
Head of IR and Corporate Communications ir@silence-therapeutics.com
Tel: +1 (646) 637-3208
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