– Positive SLN360 data to be presented in late
breaker at the American College of Cardiology (ACC) Annual Meeting
on April 3, 2022
– SLN124 phase 1 study in thalassemia now fully
enrolled; on-track for topline data in Q3 2022
– SLN124 granted FDA orphan drug designation in
polycythemia vera; on-track to start phase 1 study in H2 2022
Silence Therapeutics plc, Nasdaq: SLN (“Silence” or “the
Company”), a leader in the discovery, development and delivery of
novel short interfering ribonucleic acid (siRNA) therapeutics for
the treatment of diseases with significant unmet medical need,
today reported its financial results for the fourth quarter and
full year ended December 31, 2021 and reviewed recent business
highlights.
“2021 was a remarkable year for Silence,” said Craig Tooman,
President and Chief Executive Officer at Silence. “We successfully
delivered the first clinical data from our proprietary mRNAi GOLD™
platform, advanced two wholly owned programs in the clinic and made
excellent progress across both our proprietary and partnered
pipelines. This momentum has continued into 2022 with the positive
SLN360 data and we look forward to the late breaking presentation
at ACC on April 3rd. With clinical data now demonstrated in two
separate programs, we are optimistic about what we can deliver from
our platform and look forward to a very exciting year ahead.”
Rhonda Hellums, Chief Financial Officer at Silence commented,
“We continued to benefit from our hybrid business model in 2021,
receiving around $58 million in non-dilutive capital from our
collaborations. We moved exclusively to the Nasdaq and
significantly expanded our global shareholder base. We ended the
year with £73.5 million in cash, cash equivalents and term deposits
and we will continue to prioritize non-dilutive financing
solutions.”
Fourth Quarter 2021 Business Highlights
mRNAi GOLD™ Proprietary Program
Updates
SLN360 Lp(a) Lowering Program
- Extended follow-up period in the single-ascending dose cohorts
up to 365 days to further assess the duration of action.
- Established therapeutic dose range based on single-ascending
dose cohorts 1-4 to proceed to the multiple-ascending dose
portion.
SLN124 Hepcidin Regulation Program
- Presented clinical data from the SLN124 healthy volunteer study
at the 2021 American Society of Hematology Annual Meeting. Key data
included:
- All 3 dose levels were well tolerated with no serious or severe
treatment emergent adverse events (TEAEs) or TEAEs leading to
withdrawal.
- Average hepcidin, a key endogenous regulator of iron balance
and distribution, increased up to ~4-fold after a single dose with
effect sustained for at least 2 months.
- Serum iron reduced by ~50% after a single dose with effect
sustained for at least 2 months.
mRNAi GOLD™ Partnered Program
Updates
- Secured new collaboration with Hansoh Pharma to develop
therapeutics leveraging the Silence mRNAi GOLD™ platform, providing
the Company with exclusive rights to two undisclosed targets in all
territories except the China region (Greater China, Hong Kong,
Macau and Taiwan). Hansoh received an exclusive option to license
rights to those two targets in the China region and global rights
to a third undisclosed target.
Post Year-end Highlights
- Announced positive topline data in the SLN360 phase 1
single-ascending dose study in 32 healthy adults with high Lp(a) (≥
60 mg/dL or 150 nmol/L). Topline data included:
- SLN360 was well tolerated with no clinically important safety
concerns identified.
- SLN360 reduced Lp(a) in a dose dependent manner from 46% up to
a maximum of 98% with up to an 81% reduction persisting at 150
days.
- Detailed results from the SLN360 phase 1 single-ascending dose
study will be presented in a late-breaker at the American College
of Cardiology (ACC) Annual Meeting on April 3, 2022.
- Started dosing in the SLN360 phase 1 multiple-ascending dose
study in adults with high Lp(a) that have a confirmed history of
stable atherosclerotic cardiovascular disease (“ASCVD”).
- Completed enrollment in the SLN124 phase 1 single-ascending
dose study in thalassemia patients and remain on-track to report
topline data in the third quarter of 2022.
- SLN124 granted FDA orphan drug designation in polycythemia vera
(PV) and the Company remains on-track to start a phase 1 study in
PV in the second half of 2022.
- Discontinued further enrollment in the myelodysplastic syndrome
(MDS) arm of the SLN124 phase 1 program due to recruitment
challenges in this population and the decision to prioritize spend
in thalassemia and PV indications where the Company believes it can
derive the most value in the near term.
2021 Financial Results
For the twelve-month period ending December 31, 2021, the net
loss after tax was £39.4 million, or weighted average loss per
share 44.3 pence compared to the same period in 2020 of £32.5
million, or weighted average loss per share 39.8 pence. The
increase in net loss was primarily related to increase in R&D
expenditures as the Company continues to further advance and expand
its pipeline of novel medicines.
Revenue
Revenue recognized for the year ending December 31, 2021 was
£12.4 million, compared to £5.5 million for the year ending
December 31, 2020. 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
well as the execution of new collaboration agreements in 2021.
Therefore, 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, 2021 to £7.5 million from £3.8 million in the period
ending December 31, 2020. Cost of sales includes research and
development expenditure that is directly related to work carried
out on revenue generating contracts. The increase was largely due
to the further advancement and initiation of new collaboration
programs.
Research and Development
During the year ending December 31, 2021, research and
development expenditures increased by £10.6 million to £30.8
million from £20.2 million in the year ending December 31, 2020.
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 the internal capabilities and expertise to further advance
the Company’s siRNA platform.
General and Administrative
General and administrative expenses increased by £6.0 million to
£20.0 million for the year ending December 31, 2021 from £14.0
million for the same corresponding period in 2020. This increase
was predominantly related to requirements for public company
compliance and support of the R&D portfolio including
personnel.
Liquidity, cash and cash equivalents
As of December 31, 2021, the Company had £73.5 million of cash
and cash equivalents. During 2021, the Company received $40.0
million or £30.8 million from its partner AstraZeneca, and
milestones totaling $4.0 million or £2.9 million from its partner
Mallinckrodt. The Company also received a $16.0 million upfront
payment, or £10.7 million net of taxes, from the execution of a
collaboration agreement with Hansoh in the fourth quarter of 2021.
Since 2019, Silence has received over $100 million in upfront and
milestone payments from its collaboration partners. These proceeds
provide non-dilutive capital for the continued development and
advancement of the Company’s proprietary and partnered product
candidates. The Company believes that its cash and cash equivalents
of £73.5 million as of the end of December 2021 is sufficient to
fund its operations through early 2023.
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, the initiation or completion of the
Company’s clinical trials, the anticipated timing or outcomes of
data reports from the Company’s clinical trials and the Company’s
anticipated cash runway. 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 to be 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.
Conference Call
Company management will host a live webcast to discuss its
fourth quarter and full year 2021 results and recent business
performance today at 8:00 a.m. EDT / 12:00 p.m. GMT.
Webcast link:
https://edge.media-server.com/mmc/p/k2gmhpy6
Dial-in details: New York, United States: +1 646 741 3167
United States: 1 877 870 9135 London, United Kingdom: +44 2071
928338 United Kingdom: 08002796619
Passcode: 3055614
SILENCE THERAPEUTICS
PLC
Consolidated income
statements
(in thousands, except for loss
per share)
2021
2020
£000s
£000s
Revenue
12,415
5,479
Cost of sales
(7,456)
(3,762)
Gross profit
4,959
1,717
Research and development costs
(30,765)
(20,209)
General and administrative expenses
(20,008)
(13,983)
Other losses - net
-
(3,372)
Operating loss
(45,814)
(35,847)
Finance and other expenses
(52)
(323)
Finance and other income
10
129
Loss for the year before
taxation
(45,856)
(36,041)
Taxation
6,446
3,494
Loss for the year after
taxation
(39,410)
(32,547)
Loss per ordinary equity share (basic
and diluted)
(44.3) pence
(39.8) pence
SILENCE THERAPEUTICS
PLC
Consolidated balance
sheets
(In thousands)
December 31, 2021
December 31, 2020
£000s
£000s
Non-current assets
Property, plant and equipment
1,944
1,127
Goodwill
7,592
8,125
Other intangible assets
24
17
Financial assets at amortized cost
301
303
9,861
9,572
Current assets
Cash and cash equivalents
73,537
27,449
Derivative financial instrument
-
1,492
Financial assets at amortized cost – term
deposit
-
10,000
R&D tax credit receivable
6,945
3,536
Other current assets
5,520
4,616
Trade receivables
331
29,306
86,333
76,399
Non-current liabilities
Contract liabilities
(72,501)
(51,337)
(72,501)
(51,337)
Current liabilities
Contract liabilities
(4,247)
(17,042)
Trade and other payables
(10,783)
(8,192)
Lease liability
(137)
(341)
(15,167)
(25,575)
Net assets
8,526
9,059
Capital and reserves attributable to
the owners of the parent
Share capital
4,489
4,165
Capital reserves
225,462
186,891
Translation reserve
1,541
2,218
Accumulated losses
(222,966)
(184,215)
Total shareholders equity
8,526
9,059
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220317005327/en/
Silence Therapeutics plc Gem Hopkins, Head of IR and
Corporate Communications Tel: +1 (646) 637-3208
ir@silence-therapeutics.com
Media Relations MKC Strategies Mary Conway Tel: +1
(516) 606-6545 mconway@mkcstrategies.com
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