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Silence additionally introduced optimistic topline 36-week information from ongoing part 2 examine of zerlasiran in sufferers with excessive lipoprotein(a)
Firm to host convention name and webcast right now at 8 a.m. EDT / 12 p.m. GMT
LONDON, March 13, 2024–(BUSINESS WIRE)–Silence Therapeutics plc, Nasdaq: SLN (“Silence” or “the Firm”), an skilled and modern biotechnology firm dedicated to reworking folks’s lives by silencing ailments by precision engineered medicines, right now reported its monetary outcomes for the complete 12 months ended December 31, 2023, and reviewed current enterprise highlights.
“2023 was a 12 months of sturdy execution throughout Silence as we superior our proprietary pipeline within the clinic,” mentioned Craig Tooman, President and CEO of Silence. “That’s clearly bearing fruit right now with the optimistic topline 36-week information we introduced from the continued part 2 examine of zerlasiran in sufferers with excessive Lp(a). We’re enthusiastic about these information and the potential for zerlasiran to deal with the wants of as much as 1.4 billion worldwide dwelling with excessive Lp(a). Along with zerlasiran, we’ve made wonderful progress advancing divesiran in PV and stay on-track to report part 1 information by June. On the partnering aspect, we had been happy for AstraZeneca to enter the clinic with the primary product candidate beneath our collaboration final month, additional highlighting the productiveness of our mRNAi GOLD™ platform. We sit up for extra scientific information unfolding within the coming 12 months from our proprietary applications and constructing recognition of Silence as a real platform firm.”
Current Enterprise Highlights
Zerlasiran for heart problems
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In November 2023, reported optimistic topline information in a number of dose portion of the APOLLO part 1 examine of zerlasiran in sufferers with excessive Lp(a).
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In the present day introduced optimistic topline 36-week information from the continued ALPACAR-360 part 2 examine of zerlasiran in sufferers with a median baseline Lp(a) of roughly 215 nmol/L. Zerlasiran was administered at 300 mg subcutaneously each 16 or 24 weeks and 450 mg each 24 weeks.
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Research demonstrated extremely vital reductions in Lp(a) in contrast with placebo to week 36 (main endpoint)
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Median share discount in Lp(a) of 90% or larger had been noticed for each doses at week 36
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No new security considerations had been recognized throughout this remedy interval
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The 60-week examine is ongoing and secondary endpoints, together with change in Lp(a) from baseline to week 48 (finish of remedy interval), week 60 (finish of examine) and potential results on different lipids/lipoproteins, can be evaluated
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48-week topline information anticipated within the second quarter of 2024
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Divesiran for hematological ailments
Collaborations
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In February 2024, achieved a $10 million milestone following the initiation of a part 1 trial of the primary product candidate beneath AstraZeneca collaboration.
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In March 2024, Mallinckrodt notified Silence that they won’t pursue additional improvement of SLN501 following the completion of the part 1 scientific trial. It will conclude all actions and commitments beneath the collaboration settlement.
“We ended December 2023 with roughly $68.8 million and considerably elevated our money place in early 2024 to over $200 million,” mentioned Rhonda Hellums, Chief Monetary Officer of Silence. “We’re excited to have a number of applications advancing within the clinic, supported by a considerable money place that extends our estimated runway into 2026. We additionally proceed to judge partnering alternatives that would present further non-dilutive funding and additional prolong our money runway. Trying forward, we stay dedicated to responsibly investing in initiatives that can advance our pipeline and increase our platform into new targets the place there’s clear unmet want and alternative to ship worth to sufferers.”
Monetary Highlights for 12 months Finish 2023
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Money Place: Money and money equivalents of £54.0 million ($68.8 million) as of December 2023, in contrast with £71.1 million as of December 31, 2022.
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Collaboration Income: Collaboration income was £25.4 million for the 12 months ended December 31, 2023, and £17.5 million for the 12 months ended December 31, 2022, and associated to analysis companies carried out beneath the collaboration agreements with AstraZeneca, Hansoh and Mallinckrodt.
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R&D Bills: Analysis and improvement (R&D) bills had been £44.0 million for the 12 months ended December 31, 2023, in comparison with £35.6 million for the 12 months ended December 31, 2022. The rise is a results of further scientific research and a rise in contract manufacturing actions for Silence’s proprietary applications.
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G&A Bills: Normal and administrative (G&A) bills had been £20.6 million for the 12 months ended December 31, 2023, in comparison with £19.6 million for the 12 months ended December 31, 2022. The rise is primarily resulting from non-cash inventory compensation prices.
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Web Loss: Web loss was £43.3 million, or 38.9 pence primary and diluted internet loss per share for the 12 months ended December 31, 2023, in comparison with a internet lack of £40.5 million, or 41.9 pence primary and diluted internet loss per share for the 12 months ended December 31, 2022.
Put up-Interval Monetary Highlights
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In January 2024, obtained whole proceeds of roughly $30 million (consists of roughly $20 million from ADS gross sales beneath Silence’s Gross sales Settlement and roughly $10 million in R&D tax credit score).
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In February 2024, introduced a personal placement of ADSs with gross proceeds of roughly $120 million (£94.5 million).
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In February 2024, achieved a $10 million scientific milestone beneath AstraZeneca collaboration. This can be obtained in April 2024.
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Whole ADSs excellent had been roughly 46,502,272, as of March 1, 2024.
Money and Liquidity Replace
As of December 31, 2023, we had money and money equivalents of £54.0 million ($68.8 million). With the addition of gross proceeds from our non-public placement in February 2024 of $120 million (roughly £94.4 million) earlier than deducting charges and estimated providing bills, the $30 million from proceeds from sale of ADSs beneath our ATM and receipt of our UK R&D tax credit score, and the receipt of the AstraZeneca $10 million milestone within the second quarter of 2024, we imagine that our money of over $200 million and anticipated milestones from present collaborations can be ample to fund our working bills and capital expenditure necessities into 2026. We may additionally obtain additional milestones from our present collaboration companions which is able to additional prolong our money runway.
Convention Name & Webcast Particulars
Firm administration will host a convention name and webcast right now, Wednesday, March 13, 2024, at 8 a.m. EDT / 12:00 p.m. GMT.
Webcast hyperlink: https://edge.media-server.com/mmc/p/rkramk2y
Convention name registration hyperlink: https://register.vevent.com/register/BIa97253e879ff493bb6fe3a99a6ba3532
The convention name and webcast may also be archived on the Firm’s web site at www.silence-therapeutics.com.
About Silence Therapeutics
Silence Therapeutics is creating a brand new technology of medicines by harnessing the physique’s pure mechanism of RNA interference, or RNAi, to inhibit the expression of particular goal genes thought to play a task within the pathology of ailments with vital unmet want. Silence’s proprietary mRNAi GOLD™ platform can be utilized to create siRNAs (quick interfering RNAs) that exactly goal and silence disease-associated genes within the liver, which represents a considerable alternative. Silence’s wholly owned product candidates embrace zerlasiran (SLN360) designed to deal with the excessive and prevalent unmet medical want in decreasing cardiovascular threat in folks born with excessive ranges of lipoprotein(a) and divesiran (SLN124) designed to deal with hematological ailments. Silence additionally maintains ongoing analysis and improvement collaborations with AstraZeneca and Hansoh Pharma, amongst others. For extra info, please go to https://www.silence-therapeutics.com/.
Ahead-Trying Statements
Sure statements made on this announcement are forward-looking statements throughout the which means of the U.S. Non-public Securities Litigation Reform Act of 1995 and different securities legal guidelines, together with with respect to the Firm’s money runway and forecast working money stream, the Firm’s scientific and business prospects, regulatory approvals of the Firm’s product candidates, potential partnerships or collaborations or funds beneath new and present collaborations, the initiation or completion of the Firm’s scientific trials and the anticipated timing or outcomes of knowledge stories from the Firm’s scientific trials. These forward-looking statements are usually not historic information however quite are based mostly on the Firm’s present assumptions, beliefs, expectations, estimates and projections about its trade. Phrases similar to “anticipate,” “count on,” “intend,” “plan,” “imagine,” “search,” “estimate,” and related expressions are supposed to establish forward-looking statements. These statements are usually not ensures of future efficiency and are topic to recognized and unknown dangers, uncertainties, and different elements, a few of that are past the Firm’s management, are tough to foretell, and will trigger precise outcomes to vary materially from these expressed or forecasted within the forward-looking statements, together with these dangers recognized within the Firm’s most up-to-date Admission Doc and its Annual Report on Kind 20-F filed with the U.S. Securities and Trade Fee on the date hereof. The Firm cautions safety holders and potential safety holders to not place undue reliance on these forward-looking statements, which replicate the view of the Firm solely as of the date of this announcement. The forward-looking statements made on this announcement relate solely to occasions as of the date on which the statements are made. The Firm won’t undertake any obligation to launch publicly any revisions or updates to those forward-looking statements to replicate occasions, circumstances, or unanticipated occasions occurring after the date of this announcement besides as required by legislation or by any acceptable regulatory authority.
SILENCE THERAPEUTICS plc CONSOLIDATED INCOME STATEMENTS (in hundreds, apart from loss per share) |
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2023 |
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2022 |
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2021 |
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£000s |
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£000s |
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£000s |
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Income |
|
|
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25,375 |
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17,501 |
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12,415 |
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Price of gross sales |
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|
|
|
(10,318 |
) |
|
|
(10,880 |
) |
|
|
(7,456 |
) |
Gross revenue |
|
|
|
|
15,057 |
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|
|
6,621 |
|
|
|
4,959 |
|
Analysis and improvement prices |
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|
|
|
(44,025 |
) |
|
|
(35,605 |
) |
|
|
(30,765 |
) |
Normal and administrative bills |
|
|
|
|
(20,636 |
) |
|
|
(19,609 |
) |
|
|
(20,008 |
) |
Working loss |
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|
|
|
(49,604 |
) |
|
|
(48,593 |
) |
|
|
(45,814 |
) |
Finance and different bills |
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|
|
|
(2,152 |
) |
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|
(47 |
) |
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|
(52 |
) |
Finance and different earnings |
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|
|
|
1,446 |
|
|
|
1,272 |
|
|
|
10 |
|
Loss for the 12 months earlier than taxation |
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|
|
|
(50,310 |
) |
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|
(47,368 |
) |
|
|
(45,856 |
) |
Taxation |
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|
|
|
7,043 |
|
|
|
6,879 |
|
|
|
6,446 |
|
Loss for the 12 months after taxation |
|
|
|
|
(43,267 |
) |
|
|
(40,489 |
) |
|
|
(39,410 |
) |
Loss per strange fairness share (primary and diluted) |
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|
|
(38.9) pence |
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(41.9) pence |
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(44.3) pence |
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SILENCE THERAPEUTICS plc CONSOLIDATED BALANCE SHEETS (in hundreds) |
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December 31, |
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2023 |
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2022 |
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£000s |
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£000s |
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Non-current property |
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Property, plant and gear |
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1,813 |
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2,201 |
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Goodwill |
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7,840 |
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|
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8,009 |
|
|
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Different intangible property |
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|
|
284 |
|
|
|
320 |
|
|
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Different long run property |
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|
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2,580 |
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|
|
|
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Monetary property at amortized price |
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|
|
284 |
|
|
|
284 |
|
|
||
|
|
|
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12,801 |
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|
|
10,814 |
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Present property |
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|
|
|
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Money and money equivalents |
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|
54,031 |
|
|
|
54,816 |
|
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Monetary property at amortized price |
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|
– |
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16,328 |
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R&D tax credit score receivable |
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17,627 |
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|
|
14,882 |
|
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Different present property |
|
|
|
9,135 |
|
|
|
9,745 |
|
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Commerce receivables |
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|
|
228 |
|
|
|
915 |
|
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|
|
|
|
81,021 |
|
|
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96,686 |
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Non-current liabilities |
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|
|
|
|
|
|
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Contract liabilities |
|
|
|
(58,910 |
) |
|
|
(63,485 |
) |
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Lease legal responsibility |
|
|
|
(93 |
) |
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|
– |
|
|
||
|
|
|
|
(59,003 |
) |
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|
(63,485 |
) |
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Present liabilities |
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|
|
|
|
|
|
|
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Contract liabilities |
|
|
|
(5,161 |
) |
|
|
(8,864 |
) |
|
||
Commerce and different payables |
|
|
|
(12,429 |
) |
|
|
(12,633 |
) |
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||
Lease legal responsibility |
|
|
|
(179 |
) |
|
|
(446 |
) |
|
||
|
|
|
|
(17,769 |
) |
|
|
(21,943 |
) |
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Web property |
|
|
|
17,050 |
|
|
|
22,072 |
|
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Capital and reserves attributable to the house owners of the mum or dad |
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|
|
|
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Share capital |
|
|
|
5,942 |
|
|
|
5,390 |
|
|
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Capital reserves |
|
|
|
313,769 |
|
|
|
277,860 |
|
|
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Translation reserve |
|
|
|
1,951 |
|
|
|
2,085 |
|
|
||
Accrued losses |
|
|
|
(304,612 |
) |
|
|
(263,263 |
) |
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||
Whole shareholders fairness |
|
|
|
17,050 |
|
|
|
22,072 |
|
|
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View supply model on businesswire.com: https://www.businesswire.com/news/home/20240313711941/en/
Contacts
Inquiries:
Silence Therapeutics plc
Gem Hopkins, Head of IR and Company Communications
ir@silence-therapeutics.com
Tel: +1 (646) 637-3208
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