TIDMSLN
RNS Number : 7278Q
Silence Therapeutics PLC
23 June 2020
Business Update
23 June 2020
LONDON, Silence Therapeutics plc (LON: SLN) ("Silence" or "the
Company"), a leader in the discovery, development and delivery of
novel RNA therapeutics for the treatment of serious diseases, today
provides a mid-year business update. The Company has today
separately announced that it has confidentially submitted a
registration statement to the U.S. Securities and Exchange
Commission (the "SEC") in connection with a proposed listing of
American Depositary Shares ("ADSs") representing the Company's
ordinary shares on the Nasdaq Capital Market ("Nasdaq").
The Company confirms the progress on the clinical development of
its lead assets and a further strengthening of its senior
leadership team and Scientific Advisory Board as follows:
Pipeline and clinical development remain on track
SLN360
Preparations to submit to the FDA an investigational new drug
(IND) package for the prioritised and wholly-owned asset, SLN360,
are on schedule for later this year.
SLN124
-- SLN124, in late stage pre-clinical development, has received
Rare Paediatric Disease Designation (RPDD) for beta-thalassaemia
and Orphan Drug Designation for myelodysplastic syndrome (MDS) from
the FDA. Patient recruitment will recommence under two new
protocols, SLN124-002 and SLN124-003, with clinical trial
applications (CTAs) to be filed in H2 2020 for both protocols.
-- SLN124-002 will be a global, randomized, single-blind,
placebo-controlled Phase Ib single-ascending dose and multiple dose
study in up to 112 adults with non-transfusion dependent
thalassemia and very low- and low-risk MDS. The study is designed
to investigate the safety, tolerability, pharmacokinetic and
pharmacodynamic response to SLN124.
-- SLN124-003 will be a randomised, double-blind
placebo-controlled Phase I single-ascending dose study in healthy
volunteers to evaluate the safety, tolerability, pharmacokinetics
and pharmacodynamics of SLN124. Up to 24 healthy volunteers are
expected to be treated.
Strengthened team
-- Eric Floyd has been appointed as SVP, Head of Global
Regulatory Affairs, as from July, following an effective
consultancy role with the Company during which time he played a
pivotal role in securing the RPDD and Orphan Drug Designation
granted for SLN124 by the FDA. Eric will be based in our US
Office.
-- Dr. John Whittaker has joined the Scientific Advisory Board.
John is currently a VP in Human Genetics at GSK, where his main
role is working on the identification of the causal genes and
mechanisms underlying genetic association signals. Prior to GSK,
John was Professor of Genetic Epidemiology and Statistics at the
London School of Hygiene and Tropical Medicine.
Strong cash position
-- As of 29 May 2020, the Company had cash, cash equivalents and
short-term deposits of GBP52.0 million, reflecting the proceeds
from the issuance of ordinary shares to AstraZeneca in March 2020
and a $20 million upfront payment from AstraZeneca received in May
2020. The Company is unconditionally entitled to receive a further
$40.0 million from AstraZeneca no later than the first half of
2021.
Iain Ross, Executive Chairman of Silence Therapeutics, said:
"2020 to date has seen Silence continue to make exceptional
progress in securing additional high value partnerships, advancing
our proprietary pipeline and further augmenting our senior team.
The Board is continuing its search for a new CEO as we move on to
the next exciting phase of expansion for the Company with our
intention to issue ADSs on Nasdaq. We continue to monitor the
evolving COVID-19 pandemic but are pleased to note that we have not
experienced any significant disruption to our operations. Our
significantly strengthened balance sheet ensures that we are in a
robust position to weather any uncertainty whilst equipping us with
the capital to further accelerate our important RNAi programmes and
platform."
For more information, please contact:
Silence Therapeutics plc Tel: +44 (0)20 3457
Iain Ross, Executive Chairman 6900
Dr Rob Quinn, Chief Financial Officer
Investec (Nominated Adviser and Broker) Tel: +44 (0) 20
Daniel Adams/Gary Clarence 7597 5970
European IR Tel: +44 (0) 20
Consilium Strategic Communications 3709 5700
Mary-Jane Elliott/Chris Welsh/Angela Gray
silencetherapeutics@consilium-comms.com
U.S. IR Tel: +1 (443) 213-0505
Westwicke
Peter Vozzo
peter.vozzo@westwicke.com
About Silence Therapeutics plc
Silence Therapeutics is developing a new generation of medicines
by harnessing the body's natural mechanism of RNA interference, or
RNAi, within its cells. Its proprietary technology can selectively
inhibit any gene in the genome, specifically silencing the
production of disease-associated proteins. Silence's proprietary
RNA chemistries and delivery systems are designed to improve the
stability of molecules and enhance effective delivery to target
cells, providing a powerful modular technology well suited to
tackle life-threatening diseases. The Company has secured high
value research and collaboration agreements with AstraZeneca,
Mallinckrodt Pharmaceuticals and Takeda. For more information,
please visit: https://www.silence-therapeutics.com/
Forward Looking Statements
Certain statements made in this announcement are forward-looking
statements including with respect to the proposed listing of ADSs
representing the Company's ordinary shares on Nasdaq and the timing
and design of any planned clinical trials of the Company's product
candidates. 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 if the Company's registration statement is not declared
effective by the SEC or if Nasdaq fails to approve the Company's
ADS listing application, or if applicable regulatory authorities
fail to approve the Company's applications to undertake clinical
trials in the manner requested by the Company. The Company cautions
securityholders and prospective securityholders 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.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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