Company to host fourth quarter conference call and webcast today
at 8 a.m. EDT / 12 p.m. GMT
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 fourth quarter and full year ended
December 31, 2022 and reviewed recent business highlights.
“With a strong finish to 2022 and a great start to 2023, Silence
is well positioned for an impactful year highlighted by our
advancing clinical pipeline,” said Craig Tooman, President and CEO
of Silence. “We remain very focused on executing against the
zerlasiran (SLN360) and SLN124 clinical programs while continuing
to buildout our broader pipeline both internally and through our
partnerships. Along with our clinical advancements, our technology
is increasingly being acknowledged as a platform.”
“We are committed to responsibly investing in initiatives that
will advance our pipeline and expanding our platform into new
targets,” said Rhonda Hellums, Chief Financial Officer of Silence.
“We believe we are well positioned to advance our clinical pipeline
and will continue to evaluate collaborations that could provide
additional non-dilutive funding opportunities.”
Fourth Quarter 2022 and Recent Business Highlights
Wholly Owned Programs
Zerlasiran (SLN360) - cardiovascular disease
- In November 2022, we presented a further analysis from the
APOLLO phase 1 program in healthy adults with high Lp(a) in a
moderated poster session at the American Heart Association Annual
Meeting. The analysis showed median time-averaged reductions during
150 days of follow up exceeded 80% in 300 mg and 600 mg treatment
groups.
- In December 2022, SLN360's INN (international nonproprietary
name) was approved – zerlasiran.
- In January 2023, we started dosing subjects in the ALPACAR-360
phase 2 clinical trial evaluating zerlasiran in patients with high
Lp(a) ≥ 125 nmol/L at high-risk of atherosclerotic cardiovascular
disease (ASCVD) events.
- In February 2023, we started dosing the last subject in the
multiple dose portion of the APOLLO phase 1 study of zerlasiran in
people with high Lp(a) ≥ 150 nmol/L and stable ASCVD. We remain
on-track to report topline data in the fourth quarter of 2023.
SLN124 - hematological conditions
- In January 2023, we opened sites for enrollment in the SANRECO
phase 1/2 clinical program of SLN124 in polycythemia vera
patients.
- In March 2023, we completed dosing in the multiple dose portion
of the GEMINI II phase 1 study of SLN124 in thalassemia patients.
We remain on track to report topline data in the fourth quarter of
2023.
Partnered Programs
Hansoh Collaboration
- In December 2022, we initiated work on the second target under
our Hansoh collaboration. We retain global rights to this target
outside the China Region.
Fourth Quarter and Full Year 2022 Financial Results
For the twelve-month period ending December 31, 2022, the net
loss after tax was £40.5 million, or weighted average loss per
share 41.9 pence compared to the same period in 2021 of £39.4
million, or weighted average loss per share 44.3 pence. The
increase in net loss was primarily related to an increase in
R&D expenditures as the Company continues to further advance
and expand its pipeline of innovative medicines.
Revenue Revenue recognized for the year ending December
31, 2022 increased to £17.5 million, compared to £12.4 million for
the year ending December 31, 2021. The Company records revenue from
collaborations based on percentage of contract completion and the
increase was driven by the advancement of current collaboration
programs. As the Company’s current collaboration programs progress
and additional programs are initiated revenues are also expected to
increase over time.
Cost of sales The cost of sales increased for the twelve
months ending December 31, 2022 to £10.9 million from £7.5 million
in the period ending December 31, 2021. Cost of sales includes
research and development expenditure that is directly related to
work carried out on revenue generating contracts.
Research and Development During the year ending December
31, 2022, research and development expenditures were £35.6 million,
compared to £30.8 million for the year ending December 31, 2021.
The increase is a result of additional clinical studies and an
increase in contract manufacturing activities for Silence’s
proprietary programs, as well as an increase in personnel costs to
expand internal capabilities and expertise to further advance the
Company’s siRNA platform.
General and Administrative General and administrative
expenses decreased by £0.4 million to £19.6 million for the year
ending December 31, 2022 from £20.0 million for the same
corresponding period in 2021. The decrease was mainly due to a
reduction in consulting and recruiting costs as well as the
monitoring of administrative expenses.
Liquidity, cash and cash equivalents As of December 31,
2022, we had cash, cash equivalents and U.S. Treasury Bills of
£71.1 million ($86.0 million), which reflects the registered direct
offering of 5,950,000 ADSs in August 2022. Our aggregate gross
proceeds from this offering were $56.5 million (approximately £46.4
million) before deducting $4.1 million (approximately £3.3 million)
in underwriting discounts, commissions and estimated offering
expenses. We believe that our current cash, cash equivalents and
U.S. Treasury Bills will be sufficient to fund our operating
expenses and capital expenditure requirements through the first
quarter of 2024. We may also achieve further milestones from our
current collaboration partners which will further extend our cash
runway.
Conference Call & Webcast
Company management will host a conference call and webcast
today, Wednesday, March 15, 2023, at 8 a.m. EDT / 12:00 p.m. GMT to
discuss fourth quarter and full year 2022 results.
Webcast link:
https://edge.media-server.com/mmc/p/7vduw4ku
Conference call registration link:
https://register.vevent.com/register/BIbe6ada25ddb74c528acb36048aec7227
The conference call and webcast will also be archived on the
Company’s website at www.silence-therapeutics.com.
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 (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 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 the date hereof. 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.
SILENCE THERAPEUTICS
plc
CONSOLIDATED INCOME
STATEMENTS
(in thousands, except for loss
per share)
2022
2021
2020
£000s
£000s
£000s
Revenue
17,501
12,415
5,479
Cost of sales
(10,880
)
(7,456
)
(3,762
)
Gross profit
6,621
4,959
1,717
Research and development costs
(35,605
)
(30,765
)
(20,209
)
General and administrative expenses
(19,609
)
(20,008
)
(13,983
)
Other losses - net
-
-
(3,372
)
Operating loss
(48,593
)
(45,814
)
(35,847
)
Finance and other expenses
(47
)
(52
)
(323
)
Finance and other income
1,272
10
129
Loss for the year before
taxation
(47,368
)
(45,856
)
(36,041
)
Taxation
6,879
6,446
3,494
Loss for the year after
taxation
(40,489
)
(39,410
)
(32,547
)
Loss per ordinary equity share (basic
and diluted)
(41.9) pence
(44.3) pence
(39.8) pence
SILENCE THERAPEUTICS
plc
CONSOLIDATED BALANCE
SHEETS
(in thousands)
December 31,
2022
2021
£000s
£000s
Non-current assets
Property, plant and equipment
2,201
1,944
Goodwill
8,009
7,592
Other intangible assets
320
24
Financial assets at amortized cost
284
301
10,814
9,861
Current assets
Cash and cash equivalents
54,816
73,537
Financial assets at amortized cost
16,328
-
R&D tax credit receivable
14,882
6,945
Other current assets
9,745
5,520
Trade receivables
915
331
96,686
86,333
Non-current liabilities
Contract liabilities
(63,485
)
(72,501
)
(63,485
)
(72,501
)
Current liabilities
Contract liabilities
(8,864
)
(4,247
)
Trade and other payables
(12,633
)
(10,783
)
Lease liability
(446
)
(137
)
(21,943
)
(15,167
)
Net assets
22,072
8,526
Capital and reserves attributable to
the owners of the parent
Share capital
5,390
4,489
Capital reserves
277,860
225,462
Translation reserve
2,085
1,541
Accumulated losses
(263,263
)
(222,966
)
Total shareholders equity
22,072
8,526
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230315005297/en/
Enquiries: Silence Therapeutics plc Gem Hopkins,
Head of IR and Corporate Communications ir@silence-therapeutics.com
+1 (646) 637-3208
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