SLN124 phase 1/2 study in polycythemia vera
progressing well – data expected in mid-2024
Zerlasiran multiple dose study in patients with
high Lp(a) and stable ASCVD showed significant and durable
reductions in Lp(a) of up to 99%
Fully enrolled zerlasiran phase 2 study in
patients with high Lp(a) at high risk of ASCVD events on-track for
36-week topline data readout in 1Q 2024
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, 2023
and reviewed recent business highlights.
“This has been a year of strong execution across Silence,” said
Craig Tooman, President and CEO at Silence. “We continue to see
great results emerge from our mRNAi GOLD™ platform, including the
very rapid enrollment of our zerlasiran phase 2 trial for high
Lp(a) in just four months, the initiation and good progression of
our PV trial, and the important milestones achieved in our
AstraZeneca and Hansoh research collaborations. We remain well
positioned with important additional data milestones in the short
term.”
Third Quarter 2023 and Recent Business Highlights
mRNAi GOLD™ Proprietary Program
Updates
Zerlasiran (cardiovascular disease)
- Announced positive topline data in the multiple dose portion of
the APOLLO phase 1 study in subjects with high lipoprotein(a)
(“Lp(a)”) and stable atherosclerotic cardiovascular disease
(“ASCVD”). Data highlights included:
- Showed significant and durable reductions in Lp(a) of up to
99%
- Lp(a) levels remained around 90% lower than baseline at study
endpoint
- Well tolerated; no clinically important safety concerns were
identified
- Continued to advance the fully enrolled ALPACAR-360 phase 2
study in subjects with high Lp(a) at high risk of ASCVD
events.
SLN124 (hematological disorders)
- Advanced enrollment into the phase 1 portion of the SANRECO
phase 1/2 study in polycythemia vera (“PV”) patients and provided
guidance for data in mid-2024.
- Completed the multiple dose portion of the GEMINI II phase 1
study in non-transfusion dependent thalassemia patients. SLN124 was
well tolerated at all doses with no safety issues identified. While
proof of mechanism has been established in healthy volunteers, the
effects on indicators of iron metabolism were variable in this
study population of heterogeneous thalassemia subjects. Silence is
prioritizing R&D efforts on the ongoing PV program and does not
have plans to advance development in thalassemia at this time.
Anticipated Milestones
- Zerlasiran phase 2 topline 36-week data in the first quarter of
2024 and topline 48-week data in the second quarter of 2024.
- SLN124 data from the phase 1 portion of the SANRECO PV study
expected in mid-2024.
Third Quarter 2023 Financial Results
For the three-month period ending September 30, 2023, the net
loss after tax was £8.3 million, or weighted average loss per share
of 7.4 pence, compared to £7.1 million, or weighted average loss
per share of 7.2 pence, for the same period in 2022. The increase
in net loss was primarily related to a decrease in finance and
other income as a result of fluctuations in foreign exchange
rates.
For the nine-month period ending September 30, 2023, the net
loss after tax was £28.9 million, or weighted average loss per
share of 26.4 pence, compared to £26.7 million, or weighted average
loss per share of 28.8 pence, for the same period in 2022. The
increase in net loss for the nine-month period was primarily
related to an increase in research and development expense as we
advance our pipeline partially offset by an increase in gross
profit from our collaboration agreements.
Revenue
Revenue recognized for the quarter ending September 30, 2023 was
£2.8 million, compared to £3.4 million for the quarter ending
September 30, 2022. For the nine-month period ending September 30,
2023, revenue recognized was £23.3 million, compared to £12.7
million for same period in 2022. The Company records revenue from
collaborations based on percentage of contract completion. The
increase in 2023 was primarily a result of our Mallinckrodt
collaboration, in which we reacquired exclusive worldwide rights to
two preclinical siRNA assets resulting in a modification of the
agreement and the achievement of a $14 million in milestones from
our existing collaboration agreements.
Cost of sales
The cost of sales decreased for the three months ending
September 30, 2023 to £1.6 million from £2.4 million in the
three-month period ending September 30, 2022. The cost of sales
increased for the nine-month period ending September 30, 2023 to
£9.0 million from £7.0 million for the same period in 2022. Cost of
sales includes research and development expenditure that is
directly related to work carried out on revenue-generating
contracts. The increase for the nine-month period was largely due
to the further advancement of collaboration programs.
Research and Development
During the three-month period ending September 30, 2023,
research and development expenditures were £8.9 million compared to
£8.8 million for the same three-month period in 2022. Research and
development expenditures increased for the nine-month period ending
September 30, 2023 to £34.1 million from £27.2 million for the same
period in 2022. This was largely due to an increase in contracted
research and development expenses as we continue to advance the
SLN124 and SLN360 studies.
General and Administrative
General and administrative expenses decreased by £0.9 million to
£5.0 million for the three-month period ending September 30, 2023
from £5.8 million for the corresponding period in 2022. For the
nine-month period ending September 30, 2023, general and
administrative expenses increased to £16.5 million compared to
£16.1 million for the same period in 2022. This increase was
predominantly related to the increase in equity-based
compensation.
Liquidity, cash and cash equivalents
As of September 30, 2023, the Company had £58.8 million of cash
and cash equivalents and U.S. Treasury Bills, or approximately
$71.7 million. During the three months ended September 30, 2023, we
raised net proceeds of approximately $15.2 million. We believe that
our current cash, cash equivalents and U.S. Treasury Bills will
extend the ability to fund operations into the first quarter of
2025.
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 zerlasiran 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
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 cash
runway and forecast operating cash flow, 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
“anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,”
“estimate,” 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
on March 15, 2023. 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, 2023
September 30, 2022
September 30, 2023
September 30, 2022
£000s (except per share information)
£000s
£000s
£000s
£000s
Revenue
2,798
3,371
23,276
12,736
Cost of sales
(1,607
)
(2,394
)
(8,972
)
(7,021
)
Gross profit
1,191
977
14,304
5,715
Research and development costs
(8,934
)
(8,771
)
(34,088
)
(27,206
)
General and administrative expenses
(4,956
)
(5,827
)
(16,521
)
(16,141
)
Operating loss
(12,699
)
(13,621
)
(36,305
)
(37,632
)
Finance and other expenses
(8
)
(34
)
(97
)
(34
)
Finance and other income
2,046
4,329
1,058
5,348
Loss for the period before
taxation
(10,661
)
(9,326
)
(35,344
)
(32,318
)
Taxation
2,411
2,223
6,489
5,592
Loss for the period after
taxation
(8,250
)
(7,103
)
(28,855
)
(26,726
)
Loss per ordinary share (basic and
diluted)
(7.4) pence
(7.2) pence
(26.4) pence
(28.8) pence
Condensed consolidated balance sheet (unaudited)
September 30, 2023
December 31, 2022
£000s
£000s
Non-current assets
Property, plant and equipment
1,927
2,201
Goodwill
7,835
8,009
Other intangible assets
293
320
Financial assets at amortized cost
284
284
10,339
10,814
Current assets
Cash and cash equivalents
58,812
54,816
Financial assets at amortized cost
-
16,328
R&D tax credit receivable
17,006
14,882
Other current assets
11,323
9,745
Trade receivables
462
915
87,603
96,686
Non-current liabilities
Contract liabilities
(59,813
)
(63,485
)
Lease liability
(114
)
-
(59,927
)
(63,485
)
Current liabilities
Contract liabilities
(5,871
)
(8,864
)
Trade and other payables
(11,945
)
(12,633
)
Lease liability
(201
)
(446
)
(18,017
)
(21,943
)
Net assets
19,998
22,072
Capital and reserves attributable to
the owners of the parent
Share capital
5,800
5,390
Capital reserves
302,848
277,860
Translation reserve
1,955
2,085
Accumulated losses
(290,605
)
(263,263
)
Total shareholders' equity
19,998
22,072
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231114340624/en/
Inquiries: Silence Therapeutics plc Gem Hopkins,
VP, IR and Corporate Communications ir@silence-therapeutics.com +1
(646) 637-3208
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