Silence Therapeutics plc, Nasdaq: SLN (“Silence” or “the
Company”), an experienced and innovative biotechnology company
committed to transforming people’s lives by silencing diseases
through precision engineered medicines, today reported its
financial results for the first quarter ended March 31, 2023 and
reviewed recent business highlights.
“2023 has been marked by strong execution across all areas of
our business,” said Craig Tooman, President and Chief Executive
Officer at Silence. “We completed enrollment in the zerlasiran
phase 2 study in four months which exceeded expectations, advanced
SLN124 in the clinic and expanded our wholly owned pipeline with
two very promising complement assets. We also made great headway
with our partnered programs, including the achievement of a key
milestone which will result in a $10 million payment in our
AstraZeneca collaboration. Our technology is increasingly being
recognized as a platform and we expect this to continue along with
our clinical advancement.”
First Quarter 2023 and Recent Business Highlights
mRNAi GOLD™ Proprietary Program
Updates
zerlasiran (cardiovascular disease)
- In January 2023, we initiated the ALPACAR-360 phase 2 study in
subjects with atherosclerotic cardiovascular disease (“ASCVD”) and
high lipoprotein(a) (“Lp(a)”). In May 2023, we announced complete
enrollment in the ALPACAR-360 phase 2 study. We expect to report
topline data in mid-2024.
- In April 2023, we completed dosing in the multiple dose portion
of the APOLLO phase 1 study in subjects with stable ASCVD and high
Lp(a). We remain on-track to report topline data in the fourth
quarter of 2023.
SLN124 (hematological disorders)
- In January 2023, we initiated the SANRECO phase 1/2 study in
patients with polycythemia vera (“PV”).
- In March 2023, we completed dosing in the multiple dose portion
of the GEMINI II phase 1 study in thalassemia patients. We remain
on-track to report topline data in the fourth quarter of 2023.
mRNAi GOLD™ Partnered Program
Updates
- In March 2023, we acquired back exclusive worldwide rights to
two preclinical siRNA assets under our Mallinckrodt collaboration
for complement-mediated diseases. Under the terms of the agreement,
Silence did not make any upfront payment and Mallinckrodt is
eligible to receive future success-based milestones and low single
digit royalties on net sales if the projects advance. SLN501, the
C3 targeting program, remains under the original collaboration
agreement.
- In May 2023, we achieved a $10.0 million milestone payment from
AstraZeneca following the nomination of the first product candidate
under our siRNA (“short interfering RNA”) collaboration focused on
cardiovascular, renal, metabolic and respiratory diseases.
“We remain committed to responsibly investing in our pipeline
and on initiatives where we see high value potential,” said Rhonda
Hellums, Chief Financial Officer at Silence. “We ended March with
approximately $77.8 million in cash and cash equivalents. In May,
we achieved a $10 million milestone from our AstraZeneca
collaboration, and we expect to receive additional non-dilutive
capital from our existing partnerships, which we believe will
further extend our cash runway beyond the zerlasiran phase 2 data
readout.”
First Quarter 2023 Financial Results
For the three-month period ending March 31, 2023, the net loss
after tax was £10.2 million, or weighted average loss per share of
9.5 pence, compared to £7.7 million, or weighted average loss per
share of 8.6 pence, for the same period in 2022. The increase in
net loss was primarily related to increased research and
development spend offset by an increase in revenues from our
collaboration agreements as we achieved an additional milestone and
continue to further advance the programs.
Revenue
Revenue recognized for the quarter ending March 31, 2023 was
£11.4 million, compared to £5.7 million for the quarter ending
March 31, 2022. The Company records revenue from collaborations
based on percentage of contract completion and the increase was
primarily a result of our Mallinckrodt collaboration in which we
reacquired exclusive worldwide rights to two preclinical siRNA
assets. This resulted in a modification of the agreement triggering
additional revenue recognized.
Cost of sales
The cost of sales increased for the three months ending March
31, 2023 to £4.5 million from £2.3 million in the period ending
March 31, 2022. 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 of collaboration programs.
Research and Development
During the period, research and development expenditures were
£12.5 million compared to £7.6 million for the same three-month
period ending March 31, 2022. This was largely due to an increase
in contracted research and development expenses of £4.2 million
resulting from advancement of the studies for SLN124 and zerlasiran
compared to the corresponding three-month period in the prior
year.
General and Administrative
General and administrative expenses increased by £0.7 million to
£6.5 million for the three-month period ending March 31, 2023 from
£5.8 million for the corresponding period in 2022. This increase
was predominantly related to increased personnel costs related to
equity-based compensation.
Liquidity, cash and cash equivalents
As of March 31, 2023, the Company had £62.9 million of cash and
cash equivalents, and U.S. Treasury Bills or approximately $77.8
million. We believe that our current cash, cash equivalents and
U.S. Treasury Bills, as well as the receipt of the $10 million
milestone achieved in May 2023 and anticipated additional future
milestone payments of up to $14 million from existing collaboration
agreements will extend the ability to fund operations through the
third quarter of 2024.
About Silence Therapeutics Silence Therapeutics is
developing a new generation of medicines by harnessing the body's
natural mechanism of RNA interference, or RNAi, to inhibit the
expression of specific target genes thought to play a role in the
pathology of diseases with significant unmet need. Silence's
proprietary mRNAi GOLD™ platform can be used to create siRNAs
(short interfering RNAs) that precisely target and silence
disease-associated genes in the liver, which represents a
substantial opportunity. Silence's wholly owned product candidates
include zerlasiran designed to address the high and prevalent unmet
medical need in reducing cardiovascular risk in people born with
high levels of lipoprotein(a) and SLN124 designed to address
hematological diseases. Silence also maintains ongoing research and
development collaborations with AstraZeneca, Mallinckrodt
Pharmaceuticals, and Hansoh Pharma, among others. For more
information, please visit
https://www.silence-therapeutics.com/.
Forward-Looking Statements Certain statements made in
this announcement are forward-looking statements within the meaning
of the U.S. Private Securities Litigation Reform Act of 1995 and
other securities laws, including with respect to the Company’s cash
runway and forecast operating cash flow, the Company’s clinical and
commercial prospects, regulatory approvals of the Company’s product
candidates, potential partnerships or collaborations or payments
under new and existing collaborations, the initiation or completion
of the Company’s clinical trials and the anticipated timing or
outcomes of data reports from the Company’s clinical trials. These
forward-looking statements are not historical facts but rather are
based on the Company's current assumptions, beliefs, expectations,
estimates and projections about its industry. Words such as
“anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,”
“estimate,” and similar expressions are intended to identify
forward-looking statements. These statements are not guarantees of
future performance and are subject to known and unknown risks,
uncertainties, and other factors, some of which are beyond the
Company's control, are difficult to predict, and could cause actual
results to differ materially from those expressed or forecasted in
the forward-looking statements, including those risks identified in
the Company’s most recent Admission Document and its Annual Report
on Form 20-F filed with the U.S. Securities and Exchange Commission
on March 15, 2023. The Company cautions security holders and
prospective security holders not to place undue reliance on these
forward-looking statements, which reflect the view of the Company
only as of the date of this announcement. The forward-looking
statements made in this announcement relate only to events as of
the date on which the statements are made. The Company will not
undertake any obligation to release publicly any revisions or
updates to these forward-looking statements to reflect events,
circumstances, or unanticipated events occurring after the date of
this announcement except as required by law or by any appropriate
regulatory authority.
Condensed consolidated income statement (unaudited)
Three months ended
Three months ended
March 31, 2023
March 31, 2022
£000s (except per share information)
'£000s
'£000s
Revenue
11,374
5,722
Cost of sales
(4,534
)
(2,275
)
Gross profit
6,840
3,447
Research and development costs
(12,539
)
(7,603
)
General and administrative expenses
(6,450
)
(5,766
)
Operating loss
(12,149
)
(9,922
)
Finance and other expenses
(860
)
-
Finance and other income
336
350
Loss for the period before
taxation
(12,673
)
(9,572
)
Taxation
2,469
1,888
Loss for the period after
taxation
(10,204
)
(7,684
)
Loss per ordinary equity share (basic
and diluted)
(9.5) pence
(8.6) pence
Condensed consolidated balance sheet (unaudited)
March 31, 2023
December 31, 2022
£000s
£000s
Non-current assets
Property, plant and equipment
2,101
2,201
Goodwill
7,962
8,009
Other intangible assets
310
320
Financial assets at amortized cost
284
284
10,657
10,814
Current assets
Cash and cash equivalents
46,731
54,816
Financial assets at amortized cost
16,135
16,328
R&D tax credit receivable
10,736
14,882
Other current assets
8,385
9,745
Trade receivables
1,693
915
83,680
96,686
Non-current liabilities
Contract liabilities
(59,765
)
(63,485
)
Lease liability
(218
)
-
(59,983
)
(63,485
)
Current liabilities
Contract liabilities
(4,338
)
(8,864
)
Trade and other payables
(13,246
)
(12,633
)
Lease liability
(180
)
(446
)
(17,764
)
(21,943
)
Net assets
16,590
22,072
Capital and reserves attributable to
the owners of the parent
Share capital
5,403
5,390
Capital reserves
281,552
277,860
Translation reserve
2,046
2,085
Accumulated losses
(272,411
)
(263,263
)
Total shareholders equity
16,590
22,072
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230516005922/en/
Inquiries: Silence Therapeutics plc Gem Hopkins,
VP, IR and Corporate Communications ir@silence-therapeutics.com
Tel: +1 (646) 637-3208
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