TIDMSLN
RNS Number : 4607S
Silence Therapeutics PLC
16 November 2021
Silence Therapeutics Reports Third Quarter 2021 Financial
Results
16 November 2021
LONDON, Silence Therapeutics plc , AIM: SLN and 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 unaudited financial
results for the quarter and nine months ended September 30,
2021.
Financial Highlights
-- Revenue for the three-month period ended September 30, 2021
increased by GBP1.2 million from the same three-month period in
2020. The growth is a result of the further advancement of the
partner programs, as well as the introduction of additional
programs with our partners. For the nine months ended September 30,
2021 revenue was GBP9.0 million (nine months ended September 30,
2020: GBP3.1 million).
-- Research and development expenses for the three months ended
September 30, 2021 were GBP7.9 million, compared to GBP3.5 million
for the three months ended September 30, 2020. For the nine months
ended September 30, 2021, research and development expenses were
GBP23.5 million as compared to GBP13.6 million for the nine months
ended September 30, 2020, an increase of GBP9.9 million. The
largest contributor to the increase in R&D spend is contracted
research and development expenses which increased by GBP5.5 million
due to the advancement of clinical studies and manufacturing of
clinical supply.
-- Administrative expenses increased GBP2.8 million for the
three months ended September 30, 2021 as compared to the same
period in 2020. For the nine months ended September 30, 2021,
administrative expenses were GBP14.6 million as compared to GBP7.8
million for the nine months ended September 30, 2020.
-- As of September 30, 2021, we had cash, cash equivalents and
term deposits of GBP76.5 million (September 30, 2020: GBP43.9
million).
De-Listing from AIM
-- On October 15, 2021, we announced our intention to cancel the
admission of our ordinary shares of nominal value GBP0.05 each
trading on AIM, with effect from November 30, 2021. Shareholders
approved the delisting on November 1, 2021. Our last day of trading
on AIM will be November 29, 2021. We will retain our listing on the
Nasdaq Global Market of American Depositary Shares, of which each
represents three Ordinary Shares, under ticker symbol "SLN". We
expect Nasdaq to become the primary trading venue for our equity
securities.
Shelf Filing Registration
-- On October 15, 2021, we filed Form F-3 registration statement
to cover the offering, issuance and sale of our securities from
time to time in one or more offerings, for an aggregate initial
offering price not to exceed $300,000,000, which includes a
prospectus supplement covering the offering, issuance and sale of
up to a maximum aggregate offering price of $100,000,000 of our
American Depositary Shares ("ADSs") each representing three
ordinary shares that may be issued and sold under the an Open
Market Sale Agreement, dated October, 15, 2021 with Jefferies
LLC.
Enquiries:
Silence Therapeutics plc Tel: +1 (646) 637-3208
Gem Hopkins, Head of IR and Corporate Communications
ir@silence-therapeutics.com
Investec Bank plc (Nominated Adviser and Tel: +44 (0) 20
Broker) 7597 5970
Daniel Adams/Gary Clarence
European PR Tel: +44 (0) 20
Consilium Strategic Communications 3709 5700
Mary-Jane Elliott/ Angela Gray / Chris Welsh
silencetherapeutics@consilium-comms.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(TM) 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
iron-loading anemia conditions. 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 and
the anticipated timing 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 expectations,
estimates, and projections about its industry; its beliefs; and
assumptions. 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 amended Annual Report on Form 20-F filed
with the U.S. Securities and Exchange Commission on April 29, 2021.
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 Three months Nine months Nine months
ended ended ended ended
--------------- -------------- --------------- ---------------
September 30, September 30, September 30, September 30,
2021 2020 2021 2020
GBP 000s (except per
share information)
-------------------- -------------- -------------- --------------- ---------------
Revenue 3,156 1,988 9,001 3,134
Cost of sales (2,052) (2,331) (5,414) (2,331)
-------------- -------------- --------------- ---------------
Gross profit 1,104 (343) 3,587 803
Research and
development costs (7,916) (3,468) (23,541) (13,647)
Administrative
expenses (5,472) (2,666) (14,597) (7,826)
Other losses - net - (3,091) - (3,091)
-------------- -------------- --------------- ---------------
Operating loss (12,284) (9,568) (34,551) (23,761)
Finance and other
expenses (64) (119) (86) (119)
Finance and other
income 296 147 8 1,011
-------------- -------------- --------------- ---------------
Loss for the period
before taxation (12,052) (9,540) (34,629) (22,869)
Taxation 2,123 462 4,653 2,762
-------------- -------------- --------------- ---------------
Loss for the period
after taxation (9,929) (9,078) (29,976) (20,107)
============== ============== =============== ===============
Loss per ordinary
equity share (basic
and diluted) (11.1) pence (11.0) pence (33.8) pence (24.7) pence
Condensed consolidated statement of comprehensive income
(unaudited)
Three months Three months Nine months Nine months
ended ended ended ended
---------------- ---------------- ---------------- ----------------
September 30, September 30, September 30, September 30,
2021 2020 2021 2020
GBP 000s GBP 000s GBP 000s GBP 000s
----------------- ---------------- ---------------- ---------------- ----------------
Loss for the period
after taxation (9,929) (9,078) (29,976) (20,107)
Other
comprehensive
expense, net of
tax:
Items that may
subsequently be
reclassified to
profit and
loss:
Foreign exchange
differences
arising on
consolidation of
foreign
operations 18 (12) (434) 573
--------------- ---------------- ---------------- ----------------
Total other
comprehensive
income/(expense)
for the period 18 (12) (434) 573
--------------- ---------------- ---------------- ----------------
Total comprehensive
expense for the
period (9,911) (9,090) (30,410) (19,534)
=============== ================ ================ ================
Condensed consolidated balance sheet (unaudited)
September 30, 2021 December 31, 2020
GBP 000s GBP 000s
-------------------------------------------------------------- ------------------- -----------------
Non-current assets
Property, plant and equipment 1,535 1,127
Goodwill 7,786 8,125
Other intangible assets 3 17
Financial assets at amortized cost 302 303
------------------ -----------------
9,626 9,572
-------------------------------------------------------------- ------------------ -----------------
Current assets
Cash and cash equivalents 71,469 27,449
Derivative financial instrument - 1,492
Financial assets at amortized cost - term deposit 5,000 10,000
Financial assets at amortized cost - other - -
R&D tax credit receivable 3,778 3,536
Other current assets 2,882 4,616
Trade receivables - 29,306
------------------ -----------------
83,129 76,399
-------------------------------------------------------------- ------------------ -----------------
Non-current liabilities
Contract liabilities (57,998) (51,337)
------------------ -----------------
(57,998) (51,337)
-------------------------------------------------------------- ------------------ -----------------
Current liabilities
Contract liabilities (9,030) (17,042)
Trade and other payables (9,236) (8,192)
Lease liability (131) (341)
------------------ -----------------
(18,397) (25,575)
-------------------------------------------------------------- ------------------ -----------------
Net assets 16,360 9,059
================== =================
Capital and reserves attributable to the owners of the parent
Share capital 4,489 4,165
Capital reserves 223,637 186,891
Translation reserve 1,784 2,218
Accumulated losses (213,550) (184,215)
------------------ -----------------
Total shareholders equity 16,360 9,059
================== =================
Condensed consolidated statement of changes in equity
(unaudited)
Share Capital Translation Accumulated
Capital Reserves Reserve Losses Total
GBP 000s GBP 000s GBP 000s GBP 000s GBP 000s
------------------------- --------- --------- ----------- ----------- --------
At January 1, 2020 3,919 167,243 1,746 (151,999) 20,909
Recognition of
share-based payments - 4,395 - - 4,395
Options exercised in the
period - (331) - 331 -
Proceeds from shares
issued 246 15,584 - - 15,830
-------- --------- ----------- ----------- --------
Transactions with owners
recognized directly
in equity 246 19,648 - 331 20,225
-------- --------- ----------- ----------- --------
Loss for the period - - - (32,547) (32,547)
Other comprehensive
income
Foreign exchange
differences arising on
consolidation of foreign
operations - - 472 - 472
-------- --------- ----------- ----------- --------
Total comprehensive expense
for the period - - 472 (32,547) (32,075)
-------- --------- ----------- ----------- --------
At December 31, 2020 4,165 186,891 2,218 (184,215) 9,059
-------- --------- ----------- ----------- --------
At January 1, 2021 4,165 186,891 2,218 (184,215) 9,059
Recognition of
share-based payments - 6,790 - - 6,790
Options exercised in the
period - (641) - 641 -
Proceeds from shares
issued 324 30,597 - - 30,921
-------- --------- ----------- ----------- --------
Transactions with owners
recognized directly
in equity 324 36,746 - 641 37,711
-------- --------- ----------- ----------- --------
Loss for the period - - - (29,976) (29,976)
Other comprehensive
expense
Foreign exchange
differences arising on
consolidation of foreign
operations - - (434) - (434)
-------- --------- ----------- ----------- --------
Total comprehensive expense
for the period - - (434) (29,976) (30,410)
-------- --------- ----------- ----------- --------
At September 30, 2021 4,489 223,637 1,784 (213,550) 16,360
======== ========= =========== =========== ========
Condensed consolidated statement of cash flows (unaudited)
Nine months ended
----------------------------------------
September 30, 2021 September 30, 2020
GBP 000s GBP 000s
-------------------------------------------------------------- ------------------- ------------------
Cash flow from operating activities
Loss before tax (34,629) (22,869)
Depreciation charges 347 295
Amortization charges 14 15
Charge for the period in respect of share-based payments 6,790 1,353
Net foreign exchange (gain)/loss (226) 3,410
Finance and other expenses 86 (801)
Finance and other income (8) (91)
Decrease/(increase) in trade and other receivables 29,306 (31,905)
Decrease/(increase) in other current assets 1,735 (2,325)
Decrease in current financial assets at amortized cost - other - 7
Increase/(decrease) in trade and other payables 1,044 (912)
Decrease in derivative financial instrument 1,492 -
(Decrease)/increase in contract liabilities (1,351) 48,454
------------------ ------------------
Cash provided/(spent) on operations 4,600 (5,369)
R&D tax credits received 4,411 -
------------------ ------------------
Net cash inflow/(outflow) from operating activities 9,011 (5,369)
------------------ ------------------
Cash flow from investing activities
Redemption of financial assets at amortized cost - term
deposits 5,000 10,000
Purchase of financial assets at amortized cost - term deposits - (20,021)
Interest received 8 86
Purchase of property, plant and equipment (784) (417)
------------------ ------------------
Net cash (outflow)/inflow from investing activities 4,224 (10,352)
------------------ ------------------
Cash flow from financing activities
Repayment of lease liabilities (210) (272)
Proceeds from issue of share capital 30,921 15,806
------------------ ------------------
Net cash inflow from financing activities 30,711 15,534
------------------ ------------------
Increase/(decrease) in cash and cash equivalents 43,946 (187)
------------------ ------------------
Cash and cash equivalents at start of the period 27,449 13,515
Effect of exchange rate fluctuations on cash and cash
equivalents held 74 587
------------------ ------------------
Cash and cash equivalents at end of the period 71,469 13,915
================== ==================
Notes to the financial statements
Nine months ended September 30, 2021
1. General information
Silence Therapeutics plc and its subsidiaries (together the
'Group') are primarily involved in the discovery, delivery and
development of RNA therapeutics. Silence Therapeutics plc, a public
company limited by shares registered in England and Wales, with
company number 02992058, is the Group's ultimate parent Company.
The Company's registered office is 27 Eastcastle Street, London,
W1W 8DH and the principal place of business is 72 Hammersmith Road,
London, W14 8TH.
These condensed interim financial statements were approved for
issue on 15 November 2021.
These condensed interim financial statements do not comprise
statutory accounts within the meaning of section 434 of the
Companies Act 2006. Statutory accounts for the year ended 31
December 2020 were approved by the board of directors on 31 March
2021 and delivered to the Registrar of Companies. The report of the
auditors on those accounts was unqualified, did not contain an
emphasis of matter paragraph and did not contain any statement
under section 498 of the Companies Act 2006.
The financial statements have not been reviewed or audited.
The Company announced on October 15, 2021, its intention to
cancel the admission of the Company's ordinary shares of nominal
value GBP0.05 each trading on AIM, with effect from November 30,
2021. Shareholders approved the delisting on November 1, 2021. The
last day of trading for the Company's ordinary shares on AIM will
be November 29, 2021.
Basis of Preparation and Accounting Policies
On 31 December 2020, IFRS as adopted by the European Union at
that date was brought into UK law and became UK-adopted
international accounting standards, with future changes being
subject to endorsement by the UK Endorsement Board. Silence
Therapeutics Plc transitioned to UK-adopted international
accounting standards in its consolidated financial statements on 1
January 2021. This change constitutes a change in accounting
framework. However, there is no impact on recognition, measurement
or disclosure in the period reported as a result of the change in
framework.
This condensed consolidated financial report for the interim
reporting period ended 30 September 2021 has been prepared in
accordance with UK-adopted International Accounting Standard 34,
'Interim Financial Reporting' (IAS 34)
The interim report does not include all of the notes of the type
normally included in an annual financial report. Accordingly, this
report is to be read in conjunction with the annual report for the
year ended 31 December 2020, which was prepared in accordance with
"international accounting standards in conformity with the
requirements of the Companies Act 2006".
The accounting policies adopted are consistent with those of the
previous financial year and corresponding interim reporting
period.
The preparation of interim financial statements requires
management to make judgements, estimates and assumptions that
affect the application of accounting policies and the reported
amounts of assets and liabilities, income and expense. Actual
results might differ from these estimates.
In preparing these condensed interim financial statements, the
significant judgements made by management in applying the Group's
accounting policies and the key sources of estimation uncertainty
are disclosed in the 'Critical Accounting Policies, Judgments and
Estimates' section on Page 21.
2. Going concern
The financial statements have been prepared on a going concern
basis that assumes that the Group will continue in operational
existence for the foreseeable future.
Since 2020, the coronavirus (COVID-19) pandemic has been
prevalent in Europe, the UK and the US where the Group's principal
operations are conducted. Significant restrictions have been
imposed by the governments of those countries where the Group has
operations, as well as the countries of external parties with which
we conduct our business. In compliance with these restrictions, the
Group and its employees have adapted to new working arrangements to
ensure business continuity as far as is reasonably practicable in
the short to medium term. This has so far proven to be effective,
with Management maintaining a strong line of communication with all
employees during this period.
The main risk posed to the Group by the pandemic is the
potential slowing of Research & Development activities
including possible knock-on delays in clinical trial data and
sustained fixed costs during periods of relative inactivity. Whilst
this would result in a lengthening of the Group's cash runway in
the medium term, in the longer term these factors could limit the
Group's ability to meet its corporate objectives. This risk is
mitigated by the receipt of $60 million (GBP47.9 million) of the
upfront payments in respect of the AstraZeneca collaboration, the
$45 million private placement (or approximately $42.0 million /
GBP30.8 million, net of expenses) and the expected mid-December
2021 receipt of $14.4 million of the upfront payment, net of taxes
withheld, related to Hansoh collaboration executed on October 14,
2021, all of which significantly increase the Group's forecasted
baseline cash runway.
Based on the current operating forecasts and plans and,
considering the cash, cash equivalents and term deposit at
September 30, 2021, the Directors are confident that the Group has
sufficient funding through early 2023. For this reason, they
continue to adopt the going concern basis in preparing the
financial statements.
3. Revenue
Revenue from collaboration agreements for the nine months ended
September 30, 2021 relates to the research collaboration agreements
the Group entered into with Mallinckrodt plc in July 2019, Takeda
Pharmaceutical Company Limited in January 2020 and AstraZeneca plc
in March 2020.
Revenue for the nine months ended September 30, 2021 comprised
GBP8,728k of research collaboration income (nine months to
September 30, 2020: GBP2,983k) and GBP273k of royalty income (nine
months to September 30, 2020: GBP151k).
Three months ended Nine months ended
------------------------------------ -----------------------------------
September 30, September 30, September 30, September 30,
2021 2020 2021 2020
GBP 000s GBP 000s GBP 000s GBP 000s
----------------- ---------------- ---------------- -----------------
Revenue from
Contracts with
Customers
Research
collaboration -
Mallinckrodt
plc 2,574 1,826 6,362 2,300
Research
collaboration -
AstraZeneca 506 11 1,777 11
Research
collaboration -
Other (29) 151 589 672
---------------- ---------------- ---------------- -----------------
Research
collaboration -
total 3,051 1,988 8,728 2,983
Royalties 105 - 273 151
---------------- ---------------- ---------------- -----------------
Total revenue from
contracts with
customers 3,156 1,988 9,001 3,134
================ ================ ================ =================
Under our collaboration agreement with Mallinckrodt, we received
an upfront cash payment of GBP16.4 million ($20 million) in 2019
and are eligible to receive specified development, regulatory and
commercial milestone payments. We received milestone payments of
GBP2.9 million (or $4 million) during the nine months ended
September 30, 2021, and GBP1.4 million (or $2 million) in respect
of the nine months ended September 30, 2020. In addition to these
payments, Mallinckrodt has agreed to fund some of our research
personnel and preclinical development costs. We recognize the
upfront payment, milestone payments, payments for personnel costs
and other research funding payments over time, in accordance with
IFRS 15. During the nine months ended September 30, 2021, we
recognized a total of GBP6.4 million in revenue under this
agreement.
Under our collaboration agreement with AstraZeneca, we received
an upfront cash payment of GBP17.1 million ($20 million) in 2020
with a further amount of GBP30.8 million ($40 million) received in
May 2021. We recognize the upfront payment and milestone payments
over time, in accordance with IFRS 15. During the nine months ended
September 30, 2021, we recognized a total of GBP1.8 million in
revenue under this agreement.
We entered into a Technology Evaluation Agreement with Takeda on
January 7, 2020 to explore the potential of our platform to
generate siRNA molecules against a novel, undisclosed target
controlled by Takeda. Under our collaboration agreement, we
received a milestone payment of GBP1.6 million ($2 million) during
the year ended December 31, 2020. We recognize the milestone
payments over time, in accordance with IFRS 15. Our activities
under the Technology Evaluation Agreement were effectively complete
as of September 30, 2021. We may negotiate to enter into an
exclusive follow-on license and collaboration agreement covering
the Takeda target at some point in the future.
4. Segment reporting
Operating segments are reported in a manner consistent with the
internal reporting provided to the Board. The chief operating
decision maker (CODM), who has been identified as the Chief
Executive Officer responsible for allocating resources and
assessing performance of the operating segments.
For the nine months ended September 30, 2021 and nine months
ended September 30, 2020, the CODM determined that the Group had
one business segment, the development of RNAi-based medicines. This
is in line with reporting to senior management. The information
used internally by the CODM is the same as that disclosed in the
financial statements.
U.S. U.K. Germany Total
GBP 000s GBP 000s GBP 000s GBP 000s
--------- -------- -------- --------
Non-current assets
As at December 31, 2020 54 689 8,829 9,572
As at September 30, 2021 17 521 9,088 9,626
Revenue analysis for the year ended December 31,
2020
Research collaboration - 5,253 - 5,253
Royalties - - 226 226
-------- -------- -------- --------
- 5,253 226 5,479
==================================================== ======== ======== ======== ========
Revenue analysis for the nine months ended September
30, 2021
Research collaboration - 8,728 - 8,728
Royalties - - 273 273
-------- -------- -------- --------
- 8,728 273 9,001
==================================================== ======== ======== ======== ========
5. Loss per ordinary equity share (basic and diluted)
The calculation of the loss per share is based on the loss for
the nine months to September 30, 2021 after taxation of GBP29,976k
(nine months ended September 30, 2020: loss of GBP20,107k) and on
the weighted average ordinary shares in issue during the nine
months ended September 30, 2021 of 88,670,141 (nine months ended
September 30, 2020: 81,360,203). For the three months ended
September 30, 2021, the calculation of the loss per share is based
on the loss after taxation of GBP9,929k (three months ended
September 30, 2020: loss of GBP9,078k) and on the weighted average
ordinary shares in issue during the three months ended September
30, 2021 of 89,740,014 (three months ended September 30, 2020:
82,826,351).
The options outstanding at September 30, 2021 and September 30,
2020 are considered to be anti-dilutive as the Group is
loss-making.
6. Goodwill
September 30, 2021 December 31, 2020
GBP 000s GBP 000s
------------------- -----------------
Balance at start of the period 8,125 7,692
Translation adjustment (339) 433
------------------ -----------------
Balance at end of the period 7,786 8,125
================== =================
7. Derivative financial instruments
Derivative financial instruments related to an open forward
currency contract measured at fair value through the income
statement. The fair value was calculated from data sourced from an
independent financial market data provider using
mid-market-end-of-day data as of December 31, 2020. The derivative
contract in place at December 31, 2020 was closed out on May 28,
2021.
The fair value of the derivative is calculated based on level 2
inputs under IFRS 13.
September 30, 2021 December 31, 2020
GBP 000s GBP 000s
------------------- -----------------
Derivatives carried at fair value - 1,492
The fair value of financial instruments that are not traded in
active market, in the case of an over-the-counter derivative, is
determined using valuation techniques which maximize the use of
observable market data and rely as little as possible on entity
specific estimates. As all significant inputs required to fair
value an instrument are observable, this derivative financial
instrument is included in level 2.
The specific valuation technique used to value this derivative
is the present value of future cash flow based on the forward
exchange rate relative to its value based on the year-end exchange
rate.
The derivative fair value movement is disclosed in the Income
Statement under "Other (losses)/gains - net". For the nine-month
period to September 30, 2021 the gain on the derivative financial
instrument (GBP1.02 million), which was closed out in May 2021,
matched the related loss (GBP1.02 million) on the receivable,
resulting in a net nil impact on the Income Statement.
8. Contract liabilities
Contract liabilities comprise entirely deferred revenue in
respect of the Mallinckrodt, Takeda and AstraZeneca plc Research
collaborations. The current contract liabilities represent the
amount of estimated revenue to be reported in the next 12 months
related to amounts invoiced to our partners. The current and
non-current contract liabilities include only recharge expenses and
milestones achieved through September 30, 2021.
September 30, 2021 December 31, 2020
GBP 000s GBP 000s
------------------- -----------------
Contract liabilities:
Current 9,030 17,042
Non-current 57,998 51,337
------------------ -----------------
Total contract liabilities 67,028 68,379
================== =================
Current Non-current Total
------------------- ----------------- --------
GBP 000s GBP 000s GBP 000s
Contract liabilities:
At January 1, 2020 2,478 15,515 17,993
Additions during period 19,779 35,822 55,601
Revenue unwound during period (5,215) - (5,215)
------------------ ----------------- --------
At December 31, 2020 17,042 51,337 68,379
================== ================= ========
At January 1, 2021 17,042 51,337 68,379
Additions during period 3,419 3,958 7,377
Revenue unwound during period (8,728) - (8,728)
Program rephasing (2,703) 2,703 -
------------------ ----------------- --------
At September 30, 2021 9,030 57,998 67,028
================== ================= ========
9. Taxation
A GBP3.8 million current tax asset was recognized in respect of
research and development tax credits in the nine months ended
September 30, 2021 (nine months ended September 30, 2020: GBP5.8
million). The asset at September 30, 2020 comprised GBP2.8 million
in respect of research and development activity for the nine months
ended September 30, 2020 and GBP3.0 million in respect of the year
ended 31 December 2019. Additionally, during the third quarter of
2021, we received research and development tax credits for the year
ended December 31, 2020 of GBP4.4 million, which resulted in an
adjustment to the credit recorded in the year ended December 31,
2020 of a further GBP0.9 million.
10. Capital reserves
Share based Capital
Share premium Merger payment redemption
account reserve reserve reserve Total
GBP 000s GBP 000s GBP 000s GBP 000s GBP 000s
-------------- ------------- ------------ ------------- --------
At January 1,
2019 133,242 22,248 2,437 5,194 163,121
Shares issued 3,767 - - - 3,767
On options in
issue during
the year 1,141 - 584 - 1,725
On vested
options
lapsed
during the
year - - - - -
On options
exercised
during the
year - - (1,370) - (1,370)
------------- ------------- ------------ ------------- --------
Movement in
the year 4,908 - (786) - 4,122
------------- ------------- ------------ ------------- --------
At December 31,
2019 138,150 22,248 1,651 5,194 167,243
============= ============= ============ ============= ========
Shares issued 15,396 - - - 15,396
On options in
issue during
the year 188 - 4,395 - 4,583
On vested
options
lapsed
during the
year - - - - -
On options
exercised
during the
year - - (331) - (331)
------------- ------------- ------------ ------------- --------
Movement in
the year 15,584 - 4,064 - 19,648
------------- ------------- ------------ ------------- --------
At December 31,
2020 153,734 22,248 5,715 5,194 186,891
============= ============= ============ ============= ========
Shares issued 32,585 - - - 32,585
On options in
issue during
the period - - 7,090 - 7,090
On vested
options
lapsed during
the period - - (300) - (300)
On options
exercised
during the
period 459 - (641) - (182)
Costs
capitalized
in respect of
issuance of
shares during
the period (2,447) - - - (2,447)
------------- ------------- ------------ ------------- --------
Movement in
the period 30,597 - 6,149 - 36,746
------------- ------------- ------------ ------------- --------
At September 30,
2021 184,331 22,248 11,864 5,194 223,637
============= ============= ============ ============= ========
September 30, 2021 December 31, 2020
GBP 000s GBP 000s
------------------- -----------------
Authorized, allotted, called up and fully paid ordinary shares, par
value GBP 0.05 4,489 4,165
Number of shares in issue 89,777,000 83,306,259
The Group has only one class of share. All ordinary shares have
equal voting rights and rank pari passu for the distribution of
dividends.
On February 5, 2021 the Group announced a private placement of
2,022,218 of the Company's American Depositary Shares ("ADSs"),
each representing three ordinary shares, at a price of US $22.50
per ADS, with new and existing institutional and accredited
investors (the "Private Placement"). The aggregate gross proceeds
of the Private Placement was US $45 million (approximately GBP33
million) before deducting approximately GBP2.4 million in placement
agent fees and other expenses. The financing syndicate included
Adage Capital Management LP, BVF Partners L.P., Consonance Capital,
Great Point Partners, LLC, and other investors.
On October 15, 2021, the Company filed a registration statement
on Form F-3 with the SEC to cover the offering, issuance and sale
of securities from time to time in one or more offerings. The
aggregate initial offering price is not to exceed $300,000,000,
which includes a sale of up to a maximum aggregate offering price
of $100,000,000 of ADSs that may be issued and sold under an Open
Market Sale Agreement, dated October 15, 2021 with Jefferies
LLC.
The Company also announced on October 15, 2021, its intention to
cancel the admission of the Company's ordinary shares of nominal
value GBP0.05 each trading on AIM, with effect from November 30,
2021. Shareholders approved the delisting on November 1, 2021. The
last day of trading for the Company's ordinary shares on AIM will
be November 29, 2021. The Company intends to retain the listing on
the Nasdaq Global Market ('Nasdaq') of ADSs under ticker symbol
SLN. The Nasdaq Global Market is expected to become the primary
trading venue for the Company's equity securities.
Details of the shares issued by the Company during the nine
months ended September 30, 2021 are as follows:
Number of shares in issue at January 1, 2020 78,370,265
Shares issued during the period 4,276,580
Options exercised at GBP 0.05 496,666
Options exercised at GBP 0.85 56,470
Options exercised at GBP 1.00 60,000
Options exercised at GBP 1.90 46,278
----------
Number of shares in issue at December 31, 2020 83,306,259
Shares issued during the period 6,066,654
Options exercised at GBP 0.05 59,114
Options exercised at GBP 0.60 80,302
Options exercised at GBP 1.06 25,000
Options exercised at GBP 1.90 198,119
----------
Number of shares in issue at June 30, 2021 89,735,448
Options exercised at GBP 0.05 10,407
Options exercised at GBP 0.60 31,145
----------
Number of shares in issue at September 30, 2021 89,777,000
----------
11. Related party transactions
Transactions between the Group and its subsidiaries, which are
related parties, have been eliminated on consolidation and are not
disclosed in this note.
During the nine months to September 30, 2021 the Group paid
GBPnil (nine months to September 30, 2020: GBP75k) to Gladstone
Partners Limited, a company controlled by Director Iain Ross. The
amounts payable were settled before the relevant period ends.
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
The statements in this discussion with respect to our plans and
strategy for our business, including expectations regarding our
future liquidity and capital resources and other non-historical
statements, are forward-looking statements. These forward-looking
statements are subject to numerous risks and uncertainties,
including the risks and uncertainties described in Exhibit 99.1
filed on Form 6-K on August 12, 2021. Our actual results may differ
materially from those contained in or implied by any
forward-looking statements.
Overview
Silence Therapeutics plc ("we", "us", "our", "the Company" or
"Silence") is a biotechnology company focused on discovering and
developing novel molecules incorporating short interfering
ribonucleic acid, or siRNA, to inhibit the expression of specific
target genes thought to play a role in the pathology of diseases
with significant unmet medical need. Our siRNA molecules are
designed to harness the body's natural mechanism of RNA
interference, or RNAi, by specifically binding to and degrading
messenger RNA, or mRNA, molecules that encode specific targeted
disease-associated proteins in a cell. By degrading the message
that encodes the disease-associated protein, the production of that
protein is reduced, and its level of activity is lowered. In the
field of RNAi therapeutics, this reduction of disease-associated
protein production and activity is referred to as "gene silencing."
Our proprietary mRNAi GOLD(TM) (GalNAc Oligonucleotide Discovery)
platform is a platform of precision engineered medicines designed
to accurately target and 'silence' specific disease-associated
genes in the liver, which represents a substantial opportunity.
Using our mRNAi GOLD(TM) platform, we have generated siRNA product
candidates both for our internal development pipeline as well as
for out-licensed programs with third-party collaborators. In May
2021, we presented the first clinical data from our mRNAi GOLD
platform that successfully translated the results from pre-clinical
models into humans.
Our proprietary clinical programs include SLN360 designed to
address the high and prevalent unmet need in reducing
cardiovascular risk in people born with high levels of
lipoprotein(a), or Lp(a), and SLN124 designed to address rare
hematological disorders, including thalassemia and myelodysplastic
syndrome, or MDS, and polycythemia vera, or PV. We are evaluating
SLN360 in the APOLLO phase 1 single-ascending dose study in healthy
individuals with high levels of Lp(a) >= 60 mg/dL. In August
2021, we announced complete enrollment in the SLN360
single-ascending dose study and we anticipate topline data in the
first quarter of 2022. We are evaluating SLN124 in the GEMINI II
phase 1 single-ascending dose studies in patients with thalassemia
and MDS. We anticipate topline data from both studies in the third
quarter of 2022. In May 2021, we reported positive topline results
from the SLN124 GEMINI healthy volunteer study, which was the first
clinical data from our mRNAi GOLD (TM) platform. The SLN124 healthy
volunteer study demonstrated safety and proof-of-mechanism to
support the ongoing SLN124 phase 1 studies in patients with
thalassemia and MDS.
Our partnered pipeline includes ongoing research and development
collaborations with leading pharmaceutical companies, such as
AstraZeneca plc, or AstraZeneca, Mallinckrodt plc, or Mallinckrodt,
Takeda Pharmaceutical Company Limited, or Takeda and Hansoh
Pharmaceutical Group Company Limited or Hansoh. These
collaborations collectively represent up to 14 pipeline programs
and up to $6 billion in potential milestones plus royalties.
There are approximately 14,000 liver-expressed genes and only
around one percent of them have been targeted by publicly known
siRNAs. We aim to maximize the substantial opportunity of our mRNAi
GOLD(TM) platform through a combination of building and advancing
our proprietary and partnered pipelines. Through this hybrid model,
we plan to significantly expand our portfolio of mRNAi GOLD (TM)
platform programs by delivering 2-3 initial new drug applications
per year from 2023.
Recent Corporate Highlights
We held a R&D Day on October 21, 2021 to provide updates on
our mRNAi GOLD(TM) platform and pipeline. The updates included the
following :
Proprietary Pipeline
SLN360
-- The independent safety review committee recommended to extend the follow-up period in the single-ascending dose study from 150 days to 365 days to fully assess the duration of action, which may be longer than initially anticipated based on preclinical modelling. The therapeutic dose range has been established based on Cohorts 1-4 (optional Cohort 5 not needed) and the study can now proceed to the multiple-ascending dose phase.
SLN124
-- We plan to pursue new polycythemia vera (PV) indication and
start a phase 1 trial in the second half of 2022.
-- We received the FDA Acceptance of the US IND in
myelodysplastic syndrome (MDS) on October 20, 2021.
-- The positive results from the healthy volunteer study
reported in May 2021 was accepted for poster presentation at the
American Society of Hematology (ASH) Annual Meeting being held
December 11-14, 2021.
Partnered Pipeline
-- On October 15, 2021, we announced a collaboration agreement with Hansoh, one of the leading biopharmaceutical companies in China, to develop siRNAs for three undisclosed targets leveraging Silence's proprietary mRNAi GOLD(TM) platform. Under the terms of the agreement, Hansoh will have the exclusive option to license rights to the first two targets in Greater China, Hong Kong, Macau and Taiwan following the completion of phase 1 studies. We will retain exclusive rights for those two targets in all other territories. Silence will be responsible for all activities up to option exercise and will retain responsibility for development outside the China region post phase 1 studies. Hansoh will also have the exclusive option to license global rights to a third target at the point of IND filing. Hansoh will be responsible for all development activities post option exercise for the third target. Hansoh will make a $16 million upfront payment and Silence is eligible to receive up to $1.3 billion in additional development, regulatory and commercial milestones. Silence will also receive royalties tiered from low double-digit to mid-teens on Hansoh net product sales.
-- In our Mallinckrodt collaboration for complement-mediated
diseases, we are progressing IND-enabling studies for SLN501 C3
targeting program and expect to initiate a phase 1 study in the
first half of 2022.
De-Listing from AIM
-- On October 15, 2021, we announced our intention to cancel the
admission of our ordinary shares of nominal value GBP0.05 each
trading on AIM, with effect from November 30, 2021. Shareholders
approved the delisting on November 1, 2021. Our last day of trading
on AIM will be November 29, 2021. We will retain our listing on the
Nasdaq Global Market of American Depositary Shares, of which each
represents three Ordinary Shares, under ticker symbol "SLN". We
expect Nasdaq to become the primary trading venue for our equity
securities.
Shelf Filing Registration
-- On October 15, 2021, we filed a registration statement on
Form F-3 to cover the offering, issuance and sale of our securities
from time to time in one or more offerings, for an aggregate
initial offering price not to exceed $300,000,000, which includes a
prospectus supplement covering the offering, issuance and sale of
up to a maximum aggregate offering price of $100,000,000 of our
American Depositary Shares ("ADSs") each representing three
ordinary shares that may be issued and sold under the an Open
Market Sale Agreement, dated October 15, 2021 with Jefferies
LLC.
Upcoming Events and Anticipated Data Milestones
-- Additional results from the SLN124 healthy volunteer study
will be presented at ASH Annual Meeting being held December 11-14,
2021.
-- Topline data from the SLN360 phase 1 single-ascending dose
study in people with high Lp(a) is anticipated in the first quarter
of 2022. The Company plans to start phase 2 development in the
second half of 2022 pending regulatory discussions.
-- Topline data from the SLN124 phase 1 single-ascending dose
studies in people with thalassemia and MDS is anticipated in the
third quarter of 2022.
-- Silence plans to initiate a phase 1 study of SLN124 in PV
patients in the second half of 2022.
-- We anticipate initiating a phase 1 study of SLN501 in our Mallinckrodt collaboration for complement-mediated diseases in the first half of 2022.
Collaboration Agreement with AstraZeneca
In March 2020, we entered into a collaboration agreement with
AstraZeneca to discover, develop and commercialize siRNA
therapeutics for the treatment of cardiovascular, renal, metabolic
and respiratory diseases. Under this agreement, AstraZeneca made an
upfront cash payment to us of $20.0 million in May 2020 (equivalent
to GBP 17.1 million as of the payment date) with a further GBP30.8
million ($40 million) received in May 2021 . In March 2020, an
affiliate of AstraZeneca also subscribed for 4,276,580 new ordinary
shares for an aggregate subscription price of $20.0 million.
We anticipate initiating work on five targets within the first
three years of the collaboration, with AstraZeneca having the
option to extend the collaboration to an additional five targets.
AstraZeneca has agreed to pay us $10.0 million upon the exercise of
each option to collaborate on an additional target. For each target
selected, we will be eligible to receive up to $140.0 million in
potential milestone payments upon the achievement of milestones
relating to the initiation of specified clinical trials, the
acceptance of specified regulatory filings and the first commercial
sale in specified jurisdictions. For each target selected, we will
also be eligible to receive up to $250.0 million in potential
commercial milestone payments, upon the achievement of specified
annual net sales levels, as well as tiered royalties as a
percentage of net sales ranging from the high single digits to the
low double digits.
We continue to advance the research and development workplans
for each identified target as scheduled and agreed to with our
collaboration partner.
Collaboration Agreement with Mallinckrodt
In July 2019, we entered into a collaboration agreement with
Mallinckrodt Pharma IP Trading DAC, a wholly owned subsidiary of
Mallinckrodt plc, to develop and commercialize RNAi drug targets
designed to silence the complement cascade in complement-mediated
disorders. Under the agreement, we granted Mallinckrodt an
exclusive worldwide license to our C3 targeting program, SLN500,
with options to license two additional complement-mediated disease
targets from us. Mallinckrodt exercised options to license two
additional complement targets from us in July 2020.
While we are responsible for the Phase 1 clinical trial in each
case, Mallinckrodt will be funding all of our research personnel
costs on a full-time equivalent, or FTE, basis associated with
preparing for and conducting the Phase 1 clinical trials. We are
also responsible for the provision of drug product for preclinical
activities and for the Phase 1 clinical trials, but any
manufacturing expense relating to the Phase 1 trial will be paid
for by Mallinckrodt. After completion of the Phase 1 clinical
trials, Mallinckrodt will assume clinical development and
responsibility for potential global commercialization.
The collaboration provides for potential additional development
and regulatory milestone payments in aggregate of up to $100
million for the initial C3 target and up to $140 million for each
of the two optioned complement-mediated disease targets, with such
milestones relating to the initiation of specified clinical trials
in specified jurisdictions, and upon the receipt of regulatory
approvals by specified authorities, in each case for multiple
indications. We are also eligible to receive potential commercial
milestone payments of up to $562.5 million upon the achievement of
specified levels of annual net sales of licensed products for each
program. We are also eligible to receive tiered, low double-digit
to high-teen percentage royalties on net sales for licensed
products for each program. We received a research milestone payment
of $2 million in October 2019 upon the initiation of work for the
first complement C3 target. In September 2020, we received another
$2 million research milestone payment following the initiation of
work on a second complement target. In February 2021, we initiated
work on the third complement target which triggered another $2
million research milestone payment. In April 2021, we received
another $2.0 million research milestone for the initiation of the
toxicology study for the first identified target.
In connection with the execution of this agreement, Mallinckrodt
made an upfront cash payment in 2019 of $20.0 million (equivalent
to GBP16.4 million as of the payment date). Under a separate
subscription agreement, Cache Holdings Limited, a wholly owned
subsidiary of Mallinckrodt plc, concurrently subscribed for
5,062,167 new ordinary shares for an aggregate subscription price
of $5.0 million (equivalent to GBP4.0 million as of the payment
date).
We continue to advance the research and development workplans
for each identified target as scheduled and agreed to with our
collaboration partner.
Financial Operations Overview
Revenue
We do not have any approved products. Accordingly, we have not
generated any revenue from product sales, and we do not expect to
generate any revenue from the sale of any products unless and until
we obtain regulatory approvals for, and commercialize any of, our
product candidates. In the future, we will seek to generate revenue
primarily from product sales and, potentially, regional or global
strategic collaborations with third parties.
Under our collaboration agreement with AstraZeneca, we received
an upfront cash payment of GBP17.1 million ($20.0 million) and an
additional payment of GBP30.8 million ($40.0 million) in May 2021.
We are also eligible to receive specified development and
commercial milestone payments as well as tiered royalties on net
sales, if any. We recognize the upfront payment and milestone
payments over time, in accordance with IFRS 15. During the nine
months ended September 30, 2021, we recognized a total of GBP 1.8
million in revenue under this agreement.
Under our collaboration agreement with Mallinckrodt, we received
an upfront cash payment of $20.0 million (GBP16.4 million as of the
payment date) and are eligible to receive specified development,
regulatory and commercial milestone payments. We received a
milestone payment of $2.0 million (GBP1.7 million as of the payment
date) in 2020 and 2 other milestone payments totaling $4.0 million
(GBP2.9 million as of the payment date) in the first half of 2021.
In addition to these potential payments, Mallinckrodt has agreed to
fund some of our research personnel and preclinical development
costs. We recognize the upfront payment, milestone payments,
payments for personnel costs and other research funding payments
over time, in accordance with IFRS 15. During the nine months ended
September 30, 2021, we recognized a total of GBP 6.4 million in
revenue under this agreement.
We entered into a Technology Evaluation Agreement with Takeda on
January 7, 2020 to explore the potential of our platform to
generate siRNA molecules against a novel, undisclosed target
controlled by Takeda. Under our collaboration agreement, during the
nine months ended September 30, 2021 we received a milestone
payment of GBPnil (nine months ended September 30, 2020: GBP0.4
million). We recognize the milestone payments over time, in
accordance with IFRS 15. Our activities under the Technology
Evaluation Agreement with Takeda were effectively complete as of
September 30, 2021. We may negotiate to enter into an exclusive
follow-on license and collaboration agreement covering the Takeda
target at some point in the future.
In December 2018, we entered into a settlement and license
agreement with Alnylam Pharmaceuticals Inc., or Alnylam, pursuant
to which we settled outstanding patent litigation with Alnylam
related to its RNAi product ONPATTRO. As part of the settlement, we
license specified patents to Alnylam, and Alnylam pays us a tiered
royalty of up to one percent of net sales of ONPATTRO in the EU. We
are eligible to receive these royalties until 2023. We invoice
Alnylam quarterly in arrears based on sales data for that quarter
as reported to us by Alnylam. Royalty revenue is recognized based
on the level of sales when the related sales occur. During the nine
months ended September 30, 2021, we recognized a total of GBP0.3
million in royalty income from Alnylam.
Cost of Sales
Cost of sales consists of research and development expenditure
that is directly related to work carried out on revenue generating
contracts. This includes salary costs that are apportioned based on
time spent by employees working on these contracts as well as costs
of materials and costs incurred under agreements with contract
research organizations, or CROs.
Operating Expenses
We classify our operating expenses into two categories: research
and development expenses and administrative expenses. Personnel
costs, including salaries, benefits, bonuses and share-based
payment expense, comprise a significant component of each of these
expense categories. We allocate expenses associated with personnel
costs based on the function performed by the respective
employees.
Research and Development Expenses
The largest component of our total operating expenses since
inception has been costs related to our research and development
activities, including the preclinical and clinical development of
our product candidates. We account for research and development
costs on an accruals basis.
Our contracted research and development expense primarily
consists of:
-- costs incurred under agreements with CROs and investigative
sites that conduct preclinical studies and clinical trials;
-- costs related to manufacturing active pharmaceutical
ingredients and drug products for preclinical studies and clinical
trials; and
-- costs for materials used for in-house research and development activities.
Our research and development personnel expense primarily
consists of:
-- salaries and personnel-related costs, including bonuses,
benefits, recruitment costs and any share-based payment expense,
for our personnel performing research and development activities or
managing those activities that have been out-sourced;
-- consultants' costs associated with target selection,
preclinical and clinical research activities, and the progression
of programs towards clinical trials;
Other research and development expense primarily consists
of:
-- costs of related facilities, equipment and other overhead
expenses that are considered directly attributable to research and
development;
-- costs associated with obtaining and maintaining patents for intellectual property; and
-- depreciation of capital assets used for research and development activities.
The successful development of our product candidates is highly
uncertain. Product candidates in later stages of clinical
development generally have higher development costs than those in
earlier stages of clinical development, primarily due to the
increased size and duration of later-stage clinical trials.
Accordingly, we expect research and development costs to increase
significantly for the foreseeable future as programs progress.
However, we do not believe that it is possible at this time to
accurately project total program-specific expenses through
commercialization. We are also unable to predict when, if ever,
material net cash inflows will commence from our product candidates
to offset these expenses. Our expenditures on current and future
preclinical and clinical development programs are subject to
numerous uncertainties in timing and cost to completion.
The duration, costs and timing of clinical trials and
development of our product candidates will depend on a variety of
factors, including:
-- the scope, rate of progress, results and expenses of our
ongoing and future clinical trials, preclinical studies and
research and development activities;
-- the potential need for additional clinical trials or
preclinical studies requested by regulatory agencies;
-- potential uncertainties in clinical trial enrollment rates or
drop-out or discontinuation rates of patients;
-- competition with other drug development companies in, and the
related expense of, identifying and enrolling patients in our
clinical trials and contracting with third-party manufacturers for
the production of the drug product needed for our clinical
trials;
-- the achievement of milestones requiring payments under in-licensing agreements, if any;
-- any significant changes in government regulation;
-- the terms and timing of any regulatory approvals;
-- the expense of filing, prosecuting, defending and enforcing
patent claims and other intellectual property rights; and
-- the ability to market, commercialize and achieve market
acceptance for any of our product candidates, if they are
approved.
We have not historically tracked research and development
expenses on a program-by-program basis for our preclinical product
candidates.
Administrative Expenses
Administrative expenses consist of personnel costs, including
salaries, bonuses, benefits, recruitment costs and share-based
payment expense for personnel in executive, finance, business
development and other support functions. Administrative expenses
also include those costs associated with being a public company,
such as general and D&O insurance, legal, audit, tax, public
relations and investor relations services.
Finance and Other Income (Expense)
Finance and other income primarily relates to interest earned on
our cash, cash equivalents and short-term deposits, as well as
foreign exchange gains. Finance and other expense primarily relates
to lease liability interest expense and foreign exchange losses.
Foreign exchange gains and losses relate to cash held in foreign
currencies (primarily Euros).
Taxation
We are subject to corporate taxation in the United Kingdom,
Germany and the United States. Due to the nature of our business,
we have generated losses since inception. Our income tax credit
recognized represents the sum of the research and development, or
R&D, tax credits recoverable in the United Kingdom. The U.K.
R&D tax credit, as described below, is fully refundable to us
and is not dependent on current or future taxable income. As a
result, we have recorded the entire benefit from the U.K. R&D
tax credit as a credit to "Taxation."
As a company that carries out extensive research and development
activities, we currently benefit from the U.K. research and
development tax credit regime for small or medium-sized
enterprises, or SMEs. Under the SME regime, we are able to
surrender some of the trading losses that arise from qualifying
R&D activities for a cash rebate of up to 33.35% of such
qualifying R&D expenditures. Qualifying expenditures are net of
any revenue contribution and largely comprise employment costs for
research staff, materials, outsourced CRO costs and R&D
consulting costs incurred as part of research projects, clinical
trial and manufacturing costs, including outsourced CRO costs,
employment costs for relevant staff and consumables incurred as
part of research and development projects. Certain subcontracted
qualifying research and development expenditures are eligible for a
cash rebate of up to 21.68%. A large portion of costs relating to
our research and development, clinical trials and manufacturing
activities are eligible for inclusion within these tax credit cash
rebate claims. We recognize research and development tax credits
when receipt is probable.
We may not be able to continue to claim research and development
tax credits in the future under the current research and
development tax credit scheme if we cease to qualify as a small or
medium-sized company which is not anticipated at the time of this
filing. However, should this occur in the future we may be able to
file under the U.K. research and development expenditure credit, or
RDEC, regime for large companies. However, the relief available
under RDEC is not as favorable as that of the SME regime.
Total estimated tax losses of GBP 142.0 million as of September
30, 2021 were available for relief against our future profits.
Unsurrendered U.K. tax losses may be carried forward indefinitely
to be offset against future taxable profits, subject to numerous
utilization criteria and restrictions. The amount that can be
offset each year is limited to GBP5.0 million plus an incremental
50% of U.K. taxable profits. After accounting for tax credits
receivable, we had accumulated tax losses for carry forward in the
United Kingdom of GBP84.1 million as of December 31, 2020. However,
in the event of a change in ownership of a U.K. company, certain
provisions may apply to restrict the utilization of carried forward
tax losses in future periods. These provisions apply where there is
a major change in the nature or conduct of a trade in connection
with the change in ownership. For the avoidance of doubt, we do not
recognize a deferred tax asset in respect of the accumulated tax
losses. In addition to our accumulated tax losses in the United
Kingdom, we also had GBP51.5 of accumulated tax losses as of
December 31, 2020 related to our operations in Germany.
In the event we generate revenues in the future, we may benefit
from the U.K. "patent box" regime that allows profits attributable
to revenues from patents or patented products to be taxed at an
effective rate of 10%.
Value Added Tax, or VAT, is charged on all qualifying goods and
services by VAT-registered businesses. Where applicable, an amount
of 20% of goods and services is added to all sales invoices and is
payable to the U.K. tax authorities. Similarly, VAT paid on
purchase invoices is reclaimable from the U.K. tax authorities.
Results of Operations
Comparison of the Three Months and Nine Months Ended September 30, 2021 and 2020
The following tables summarize the results of our operations for
the three months and nine months ended September 30, 2021 and
2020.
Consolidated Income Statements (unaudited)
Three months ended Nine months ended
---------------------------------- ---------------------------------
September 30, September 30, September 30, September 30,
2021 2020 2021 2020
GBP 000s (except per
share information)
-------------------- --------------- --------------- --------------- ---------------
Revenue 3,156 1,988 9,001 3,134
Cost of sales (2,052) (2,331) (5,414) (2,331)
--------------- --------------- --------------- ---------------
Gross profit 1,104 (343) 3,587 803
Research and
development costs (7,916) (3,468) (23,541) (13,647)
Administrative
expenses (5,472) (2,666) (14,597) (7,826)
Other (losses)/gains -
net - (3,091) - (3,091)
--------------- --------------- --------------- ---------------
Operating loss (12,284) (9,568) (34,551) (23,761)
Finance and other
expenses (64) (119) (86) (119)
Finance and other
income 296 147 8 1,011
--------------- --------------- --------------- ---------------
Loss for the period
before taxation (12,052) (9,540) (34,629) (22,869)
Taxation 2,123 462 4,653 2,762
--------------- --------------- --------------- ---------------
Loss for the period
after taxation (9,929) (9,078) (29,976) (20,107)
=============== =============== =============== ===============
Loss per ordinary
equity share (basic
and diluted) (11.1) pence (11.0) pence (33.8) pence (24.7) pence
Revenue
Revenue for the three-month period ended September 30, 2021
increased by GBP1.2 million from the same three-month period in
2020. The growth is a result of the further advancement of the
partner programs, as well as introduction of additional programs
with our partners. For the nine months ended September 30, 2021
revenue was GBP9.0 million ( nine months ended September 30, 2020:
GBP3.1 million). The increase was primarily due to the AstraZeneca
and Mallinckrodt collaborations which delivered GBP1.8 million
(nine months ended September 30, 2020: GBPnil) and GBP6.4 million
(nine months ended September 30, 2020: GBP2.3 million) of revenue
respectively in 2021.
Research and Development Expenses
The following table summarizes our research and development
expenses for the nine months ended September 30, 2021 and 2020,
based on their classification.
Three months ended Nine months ended
------------------------------------ ------------------------------------
September 30, September 30, September 30, September 30,
2021 2020 2021 2020
GBP 000s GBP 000s GBP 000s GBP 000s
----------------- ----------------- ----------------- -----------------
Research and
development
expenses
Contracted
development
costs 4,171 1,576 13,084 7,573
Personnel costs 3,268 1,561 9,284 5,126
Other costs 477 331 1,173 948
---------------- ----------------- ----------------- -----------------
Total 7,916 3,468 23,541 13,647
================ ================= ================= =================
Research and development expenses for the three months ended
September 30, 2021 were GBP7.9 million, compared to GBP3.5 million
for the three months ended September 30, 2020. For the nine months
ended September 30, 2021, research and development expenses were
GBP23.5 million as compared to GBP13.6 million for the nine months
ended September 30, 2020, an increase of GBP9.9 million. The
largest contributor to the increase in R&D spend is contracted
research and development expenses which increased by GBP5.5 million
due to the advancement of clinical studies and manufacturing of
clinical supply. Personnel expenses (including payroll,
consultants, share-based payment expense and recruitment fees),
also increased by GBP4.2 million as a result of the advancement and
addition of new R&D programs.
Administrative Expenses
Administrative expenses increased GBP2.8 million for the three
months ended September 30, 2021 as compared to the same period in
2020. The increase is primarily due to the growth of the
organization, as well as the increase in share-based payment
expense. For the nine months ended September 30, 2021,
administrative expenses were GBP14.6 million as compared to GBP7.8
million for the nine months ended September 30, 2020.
Administrative expenses consist of personnel costs, allocated
expenses and other expenses for outside professional services,
including legal, audit, tax and accounting services and public
relations and investor relations services. Personnel costs consist
of salaries, bonuses, benefits, recruitment costs and share-based
payment expense for personnel in executive, finance, business
development and other support functions. Other administrative
expenses include office space-related costs not otherwise allocated
to research and development expense, costs of our information
systems and costs for compliance with the day-to-day requirements
of being a listed public company. We anticipate that our
administrative expenses will continue to increase in the future to
support our continued research and development activities of our
product candidates.
Finance and Other Income (Expense)
Finance income/(expense) includes:
-- interest income on our cash, cash equivalents and short-term
deposits of GBP6 thousand for the three-months ended September 31,
2021 compared to GBP23 thousand for the three-months ended
September 31, 2020. For the nine-month period ended September 30,
2021, interest income was GBP8 thousand compared to GBP86 thousand
for the nine-months ended September 30, 2020. The decrease is
primarily attributable to fewer instances of funds being placed on
term deposits in 2021 primarily due a general decrease in interest
rates being offered by Deposit Taking Institutions.
-- net foreign exchange income was GBP226 thousand for the
three-months ended September 31, 2021 compared to GBP5 thousand for
the three-months ended September 31, 2020. For the nine-month
period ended September 30, 2021, net foreign exchange loss was
GBP86 thousand compared to GBP806 thousand for the nine-months
ended September 30, 2020.; foreign exchange gains/losses relate to
cash held in foreign currencies.
Taxation
We have recognized U.K. research and development tax credits of
GBP2.1 million for the three months ended September 30, 2021 as
compared to GBP0.5 million for the nine months ended September 30,
2020. For the nine-months ended September 40. 2021, we recognized
GBP3.8 million for the nine months ended September 30, 2021 and an
additional GBP0.9 million recognized and received as part of the
full year 2020 submission. This compares to GBP2.8 million for the
nine months ended September 30, 2020. We expect to receive the
amount in respect of the full year 2021 in 2022.
Quantitative and Qualitative Disclosures about Market Risk
Market risk arises from our exposure to fluctuation in interest
rates and currency exchange rates. These risks are managed by
maintaining an appropriate mix of cash deposits in the two main
currencies we operate in, which is placed with a variety of
financial institutions for varying periods according to expected
liquidity requirements.
Interest Rate Risk
As of September 30, 2021, we had cash, cash equivalents and term
deposits of GBP76.5 million (September 30, 2020: GBP43.9 million).
Our exposure to interest rate sensitivity is impacted primarily by
changes in the underlying U.K. bank interest rates. Our surplus
cash and cash equivalents are invested in interest-bearing savings
accounts and fixed term and fixed interest rate term deposits from
time to time. We have not entered into investments for trading or
speculative purposes in the year ended December 31, 2020 or the
nine months ended September 30, 2021. Due to the conservative
nature of our investment portfolio, which is predicated on capital
preservation of investments with short-term maturities, an
immediate one percentage point change in interest rates would not
have a material effect on the fair market value of our portfolio,
and therefore we do not expect our operating results or cash flows
to be significantly affected by changes in market interest
rates.
Currency Risk
Our functional currency is U.K. pounds sterling, and our
transactions are commonly denominated in that currency. However, we
receive payments under our collaboration agreements in U.S. dollars
and we incur a portion of our expenses in other currencies,
primarily Euros, and are exposed to the effects of these exchange
rates. We seek to minimize this exposure by maintaining currency
cash balances at levels appropriate to meet foreseeable short to
mid-term expenses in these other currencies. Where significant
foreign currency cash receipts are expected, we consider the use of
forward exchange contracts to manage our exchange rate exposure. A
10% increase in the value of the pound sterling relative to the
U.S. dollar or Euro would not have had a material effect on the
carrying value of our net financial assets and liabilities in
foreign currencies at September 30, 2021.
Counterparty, Credit and Liquidity Risk
Our cash, cash equivalents and term deposits are on deposit with
financial institutions with a credit rating equivalent to, or
above, the main U.K. clearing banks. We invest our liquid resources
based on the expected timing of expenditures to be made in the
ordinary course of our activities. All financial liabilities are
payable in the short term, meaning no more than three months, and
we maintain adequate bank balances in either instant access or
short-term deposits to meet those liabilities as they fall due. We
believe we have had minimal credit risk relating to our trade
receivables as of September 30, 2021 and 2020, which consisted
solely of amounts due from AstraZeneca, Mallinckrodt and
Alnylam.
Critical Accounting Policies, Judgments and Estimates
In the application of our accounting policies, we are required
to make judgments, estimates, and assumptions about the value of
assets and liabilities for which there is no definitive third-party
reference. The estimates and associated assumptions are based on
historical experience and other factors that are considered to be
relevant. Actual results may differ from these estimates. We review
our estimates and assumptions on an ongoing basis. Revisions to
accounting estimates are recognized in the period in which the
estimate is revised if the revision affects only that period or in
the period of the revisions and future periods if the revision
affects both current and future periods.
The following are our critical judgments that we have made in
the process of applying our accounting policies and that have the
most significant effect on the amounts recognized in our
consolidated financial statements included elsewhere in this
report.
Revenue Recognition under Collaboration Agreements
During the nine months ended September 30, 2021 and the nine
months ended September 30, 2020, a significant portion of our
revenue from collaboration agreements was derived from our
agreements with AstraZeneca (in 2021), Mallinckrodt ( in 2020 and
2021) and Takeda (2020 through the six months ended June 30,
2021).
For the nine months ended September 30, 2021 and 2020, we
determined actual costs and forecast costs for the remainder of the
contract. We then calculated total contract costs across the
contract term, including costs that will be reimbursed to us, and
costs incurred to date as a percentage of total contract costs. We
then multiplied this percentage by the consideration deemed
probable, calculating the cumulative revenue to be recognized. When
variable consideration increases due to a further milestone
becoming probable, a catch-up in revenue is recorded to reflect
efforts already expended by us up to that point.
AstraZeneca Research Collaboration, Option and License
Agreement
We have out-licensed the rights to some of our intellectual
property associated with our siRNA stabilization chemistry
technology to AstraZeneca through a Research Collaboration, Option
and License Agreement, dated March 24, 2020, under which we and
AstraZeneca will collaborate to discover, develop and commercialize
siRNA therapeutics for the treatment of cardiovascular, renal,
metabolic and respiratory diseases.
AstraZeneca agreed to make an upfront cash payment of $60
million, of which $20 million was paid in May 2020 and the
remaining $40 million was paid in May 2021. AstraZeneca also made
an equity investment of $20 million in the Company. We have
initially started working on two targets and anticipate initiating
work on an additional three targets within the first three years of
the collaboration, with AstraZeneca having the option to extend the
collaboration to a further five targets. AstraZeneca would be
obligated to pay us an option exercise payment of $10 million for
each option exercised.
For each target selected under the collaboration, we will be
eligible to receive up to $140 million in milestone payments upon
the achievement of milestones relating to initiation of specified
clinical trials, the acceptance of specified regulatory filings and
the first commercial sale in specified jurisdictions. For each
target selected, we are also eligible to receive up to $250 million
in sales-based milestone payments upon the achievement of specified
annual net sales levels, as well as tiered royalties as a
percentage of net sales ranging from the high single digits to the
low double digits.
As there is only a single performance obligation per target
under the collaboration agreement, the revenue for each element of
consideration will be recognized over the contract period based on
a cost-to-cost method, which is considered to be the best available
measure of our effort during the contract period. The total cost
estimate for the contract includes costs expected to be incurred
during a Phase 1 clinical trial for which we will be reimbursed.
Other variable elements of consideration will only begin to be
recognized when the amounts are considered probable.
Mallinckrodt License and Collaboration Agreement
On July 18, 2019, Mallinckrodt obtained an exclusive worldwide
license from us for an early-stage RNAi program targeting C3 in the
complement cascade (known as SLN500), with options to license
additional complement-mediated disease targets. The license of the
intellectual property and the R&D services are not distinct, as
Mallinckrodt cannot benefit from the intellectual property absent
the R&D services, since R&D services are used to discover
and develop a drug candidate and to enhance the value in the
underlying intellectual property. On this basis, we have concluded
that there is a single performance obligation covering both the
R&D services and the license of the intellectual property in
respect of each target (i.e., one for the initial target and one
for each additional optioned complement-mediated disease targets
which represent material rights). We recognize revenue over the
duration of the contract based on an input method based on cost to
cost.
The agreement with Mallinckrodt has four elements of
consideration:
-- a fixed upfront payment, which we received in July 2019;
-- subsequent milestone payments, which are variable and depend
upon our achievement of specified development, regulatory and
commercial milestones;
-- payments in respect of certain research personnel costs on an
FTE, basis, which costs are variable depending on activity under
the collaboration; and
-- funding for Phase 1 clinical development and certain
preparatory activities, including GMP manufacturing, which costs
are also variable.
The upfront payment has been allocated evenly between the
initial target and the optioned complement-mediated disease
targets, because the compounds are at a similar stage of
development, on the basis of a benchmarking exercise that took into
account the standalone selling price per target, of similar
precedent transactions that had been publicly announced by
comparable companies. The upfront payment will be recognized as
revenue in line with the time period over which services are
expected to be provided.
As there is only a single performance obligation per target
under the collaboration agreement, the revenue for each element of
consideration will be recognized over the contract period based on
a cost-to-cost method, which is considered to be the best available
measure of our effort during the contract period. The total cost
estimate for the contract includes costs expected to be incurred
during a Phase 1 clinical trial for which we will be reimbursed.
Other variable elements of consideration will only begin to be
recognized when the amounts are considered probable.
Takeda Technology Evaluation Agreement
We entered into a Technology Evaluation Agreement with Takeda on
January 7, 2020 to explore the potential of our platform to
generate siRNA molecules against a novel, undisclosed target
controlled by Takeda. Our activities under the Technology
Evaluation Agreement with Takeda were effectively complete as of
September 30, 2021. We may negotiate to enter into an exclusive
follow-on license and collaboration agreement covering the Takeda
target at some point in the future.
Recognition of Clinical Trial Expenses
As part of the process of preparing our consolidated financial
statements, we may be required to estimate accrued expenses related
to our preclinical studies and clinical trials. In order to obtain
reasonable estimates, we review open contracts and purchase orders.
In addition, we communicate with applicable personnel in order to
identify services that have been performed, but for which we have
not yet been invoiced. In most cases, our vendors provide us with
monthly invoices in arrears for services performed. We confirm our
estimates with these vendors and make adjustments as needed.
Examples of our accrued expenses include fees paid to CROs for
services performed on preclinical studies and clinical trials and
fees paid for professional services.
Recent Accounting Pronouncements
We have reviewed new IFRS standards issued and updates to
existing standards in the reporting period and concluded that none
of the recent pronouncements are relevant to Silence Therapeutics
plc (either because they relate to standards not relevant to
Silence Therapeutics plc or because they have not yet become
effective; and there is currently no preference for early
adoption). The group did not have to change its accounting policies
or make retrospective adjustments as a result.
Implications of Being an Emerging Growth Company and a Foreign
Private Issuer
We have taken advantage of reduced reporting requirements in
this report. Accordingly, the information contained herein may be
different than the information you receive from other public
companies in which you hold equity securities.
Emerging Growth Company
As of the date of this filing, we are an "emerging growth
company" as defined in the Jumpstart Our Business Startups Act of
2012, or the JOBS Act. As such, we may take advantage of certain
exemptions from various reporting requirements that are applicable
to publicly traded entities that are not emerging growth companies.
These exemptions include:
-- an exemption from the auditor attestation requirement in the
assessment of our internal control over financial reporting
pursuant to the Sarbanes-Oxley Act of 2002, as amended;
-- to the extent that we no longer qualify as a foreign private
issuer, (i) reduced disclosure obligations regarding executive
compensation in our periodic reports and proxy statements and (ii)
exemptions from the requirement to hold a non-binding advisory vote
on executive compensation, including golden parachute compensation;
and
-- an exemption from compliance with the requirement that the
Public Company Accounting Oversight Board has adopted regarding a
supplement to the auditor's report providing additional information
about the audit and the financial statements.
We will remain an emerging growth company until the earliest of
(a) the last day of our fiscal year during which we have total
annual gross revenue of at least $1.07 billion; (b) December 31,
2025; (c) the date on which we have, during the previous three-year
period, issued more than $1.0 billion in non-convertible debt; or
(d) the date on which we are deemed to be a "large accelerated
filer" under the Securities Exchange Act of 1934, as amended, which
would occur if the market value of our equity securities that are
held by non-affiliates exceeds $700 million as of the last business
day of our most recently completed second fiscal quarter. As of
September 30, 2021, we did not exceed this threshold. Once we cease
to be an emerging growth company, we will not be entitled to the
exemptions provided in the JOBS Act.
Foreign Private Issuer
We report under the Securities Exchange Act of 1934, as amended,
or the Exchange Act, as a non-U.S. company with foreign private
issuer status . Even after we no longer qualify as an emerging
growth company, as long as we continue to qualify as a foreign
private issuer under the Exchange Act, we are exempt from certain
provisions of the Exchange Act that are applicable to U.S. domestic
public companies, including:
-- the rules under the Exchange Act requiring domestic filers to
issue financial statements prepared under U.S. GAAP;
-- the sections of the Exchange Act regulating the solicitation
of proxies, consents or authorizations in respect of a security
registered under the Exchange Act;
-- the sections of the Exchange Act requiring insiders to file
public reports of their share ownership and trading activities and
liability for insiders who profit from trades made in a short
period of time; and
-- the rules under the Exchange Act requiring the filing with
the SEC of quarterly reports on Form 10-Q containing unaudited
financial statements and other specified information, and current
reports on Form 8-K upon the occurrence of specified significant
events.
Notwithstanding these exemptions, we will file with the SEC, per
foreign private issuer requirements.
We may take advantage of these exemptions until such time as we
are no longer a foreign private issuer. We would cease to be a
foreign private issuer at such time as more than 50% of our
outstanding voting securities are held directly or indirectly by
U.S. residents and any of the following three circumstances
applies: (i) the majority of our executive officers or directors
are U.S. citizens or residents, (ii) more than 50% of our assets
are located in the United States or (iii) our business is
administered principally in the United States.
Liquidity and Capital Resources
Overview
Since our inception, we have incurred significant operating
losses. We anticipate that we will continue to incur losses for at
least the next several years. We expect that our research and
development and administrative expenses will increase in connection
with conducting clinical trials and seeking marketing approval for
our product candidates, as well as costs associated with operating
as a public company. As a result, we will need additional capital
to fund our operations, which we may obtain from additional equity
financings, debt financings, research funding, collaborations,
contract and grant revenue or other sources.
As of September 30, 2021, we had cash, cash equivalents and term
deposits of GBP76.5 million (December 31, 2020: GBP37.4
million).
We do not currently have any approved products and have never
generated any revenue from product sales or otherwise. To date, we
have financed our operations primarily through the issuances of our
equity securities and from upfront, milestone and research payments
under collaboration agreements with third parties.
We have no ongoing material financing commitments, such as lines
of credit or guarantees, that are expected to affect our liquidity
over the next five years, other than leases.
Cash Flows
The following table summarizes the results of our cash flows for
the nine months ended September 30, 2021 and 2020.
Nine months ended
September 30, 2021 September 30, 2020
GBP 000s GBP 000s
------------------- ------------------
Net cash inflow/(outflow) from operating activities 9,011 (5,369)
Net cash inflow/(outflow) from investing activities 4,224 (10,352)
Net cash inflow from financing activities 30,711 15,534
------------------ ------------------
Increase/(decrease) in cash and cash equivalents 43,946 (187)
================== ==================
Operating activities
The increase in net cash generated from operating activities of
GBP9.0 million for the nine months ended September 30, 2021 from
net cash outflow of GBP5.4 million for the nine months ended
September 30, 2020 was primarily due to the $40 million ( GBP30.8
million) upfront payment from AstraZeneca in the first half of 2021
partially offset by higher research, development and administrative
costs.
Investing activities
Net cash inflow from investing activities was GBP4.2 million for
the nine months ended September 30, 2021, compared to GBP10.4
outflow for the nine months ended September 30, 2020 which was
primarily due to the purchase of short-term deposits. Short-term
deposits for the nine months ended September 30, 2021 were GBP5.0
million.
Financing activities
The increase in net cash from financing activities to GBP30.7
million for the nine months ended September 30, 2021 ( nine months
ended September 30, 2020: GBP15.5 million), was due to the proceeds
from the issuance of share capital. The only other financing
activity for the nine months ended September 30, 2021 of GBP0.2
million ( nine months ended September 30, 2020: GBP0.3 million) was
the repayment of lease liabilities.
Operating and Capital Expenditure Requirements
We have not achieved profitability on an annual basis since our
inception, and we expect to incur net losses in the future. We
expect that our operating expenses will increase as we continue to
invest to grow our product pipeline, hire additional employees and
increase research and development expenses.
Additionally, as a public company, we incur significant
additional audit, legal and other expenses. We believe that our
existing capital resources will be sufficient to fund our
operations, including currently anticipated research and
development activities and planned capital spending, at least
through the end of 2022.
Our future funding requirements will depend on many factors,
including but not limited to:
-- the scope, rate of progress and cost of our clinical trials,
preclinical programs and other related activities;
-- the extent of success in our early preclinical and
clinical-stage research programs, which will determine the amount
of funding required to further the development of our product
candidates;
-- the cost of manufacturing clinical supplies and establishing
commercial supplies of our product candidates and any products that
we may develop;
-- the costs involved in filing and prosecuting patent
applications and enforcing and defending potential patent
claims;
-- the outcome, timing and cost of regulatory approvals of our product candidates;
-- the cost and timing of establishing sales, marketing and distribution capabilities; and
-- the costs of hiring additional skilled employees to support
our continued growth and the related costs of leasing additional
office space.
Trend Information
Other than as disclosed elsewhere in this Report, we are not
aware of any trends, uncertainties, demands, commitments or events
since December 31, 2020 that are reasonably likely to have a
material adverse effect on our net revenues, income from continuing
operations, profitability, liquidity or capital resources, or that
would cause the disclosed financial information to be not
necessarily indicative of future operating results or financial
conditions. For more information, see Exhibit 99.1 filed on Form
6-K on August 12, 2021.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and do not
currently have, any off-balance sheet arrangements.
Contractual Obligations and Commitments
The following table summarizes our contractual commitments and
obligations as of September 30, 2021 and December 31, 2020.
September 30, 2021 December 31, 2020
GBP 000s GBP 000s
------------------- -----------------
Lease liability 131 341
We have agreed to make payments to CROs and manufacturers under
various CRO and manufacturing agreements that generally provide for
our ability to terminate on short notice. We have not included any
such contingent payment obligations in the table above as the
amount, timing and likelihood of such payments are not fixed or
determinable.
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END
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(END) Dow Jones Newswires
November 16, 2021 02:00 ET (07:00 GMT)
Silence Therapeutics (LSE:SLN)
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