Silence Therapeutics Reports First Quarter 2024 Results and Highlights Pipeline Progress
Phase 1Clinical ResultFinancial StatementPhase 2
LONDON--(BUSINESS WIRE)--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, 2024 and reviewed recent business highlights.
“Silence’s first quarter performance reflects another period of solid execution with the continued advancement of both our wholly owned and partnered pipelines in the clinic,” said Craig Tooman, President and Chief Executive Officer at Silence. “Silence is well positioned heading into key data readouts in our zerlasiran and divesiran programs, and we remain excited about the potential for our mRNAi GOLD™ platform to address a wide range of genetic diseases.”
First Quarter 2024 & Recent Business Highlights
Zerlasiran for cardiovascular disease
In March 2024, we announced positive topline 36-week data from the ongoing 60-week ALPACAR-360 phase 2 study of zerlasiran in patients with a median baseline Lp(a) of approximately 215 nmol/L.
Study met primary endpoint and demonstrated highly significant reductions in Lp(a) to week 36
No new safety concerns were identified during this treatment period
48-week data (end of treatment period) expected in the second quarter of 2024
In April 2024, additional phase 1 data from the APOLLO single and multiple dose study of zerlasiran in subjects with baseline Lp(a) levels at or over 150 nmol/L were published in the Journal of the American Medical Association (JAMA), linked here.
Divesiran for hematological diseases
Advanced the SANRECO phase 1 study of divesiran in polycythemia vera (PV) patients.
Emerging data from the open-label study continue to look promising
On-track to report phase 1 data by the end of June 2024
Collaborations
In February 2024, we achieved a $10 million milestone following the initiation of a phase 1 trial of the first product candidate under our AstraZeneca collaboration.
First Quarter 2024 Financial Highlights
Cash Position: Cash, cash equivalents and U.S. Treasury Bills of £152.8 million ($192.8 million) as of March 31, 2024, compared with £62.9 million ($77.8 million) as of March 31, 2023.
Collaboration Revenue: Collaboration revenue was £12.4 million, an increase of £1.0 million compared with the first quarter of 2023. The increase was primarily driven by a £9.2 million milestone received from our AstraZeneca collaboration. This was offset by a decrease in revenue from our Mallinckrodt collaboration of £8.5 million as we reacquired exclusive worldwide rights to two preclinical siRNA assets under our modified Mallinckrodt collaboration in March 2023.
R&D Expenses: Research and development (R&D) expenses were £9.2 million, a decrease of £3.4 million compared to the first quarter of 2023. The was primarily due to a decrease in contracted R&D expenses of £2.5 million resulting from the completion of the divesiran phase 1 study in thalassemia patients and timing of manufacturing activities for divesiran compared to the same period in 2023.
G&A Expenses: General and administrative (G&A) expenses were £5.2 million, a decrease of £1.3 million compared to the first quarter of 2023. The decrease is primarily due to decreased payroll costs and equity-based compensation.
Net Loss: Net loss was £1.9 million, or 1.4 pence basic and diluted net loss per share, compared to a net loss of £10.2 million, or 9.5 pence basic and diluted net loss per share for the first quarter of 2023.
Total ADSs outstanding were approximately 46,575,984, as of March 31, 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 (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 divesiran (SLN124) designed to address rare hematological diseases including polycythemia vera. Silence also maintains ongoing research and development collaborations with AstraZeneca and Hansoh Pharma, among others. For more information, please visit .
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 13, 2024. 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, 2024
March 31, 2023
£000s (except per share information)
'£000s
'£000s
Revenue
12,406
11,374
Cost of sales
(2,213
)
(4,534
)
Gross profit
10,193
6,840
Research and development costs
(9,179
)
(12,539
)
General and administrative expenses
(5,170
)
(6,450
)
Operating loss
(4,156
)
(12,149
)
Finance and other expenses
(13
)
(860
)
Finance and other income
804
336
Loss for the period before taxation
(3,365
)
(12,673
)
Taxation
1,489
2,469
Loss for the period after taxation
(1,876
)
(10,204
)
Loss per ordinary equity share (basic and diluted)
(1.4) pence
(9.5) pence
Condensed consolidated balance sheet (unaudited)
March 31, 2024
December 31, 2023
£000s
£000s
Non-current assets
Property, plant and equipment
1,791
1,813
Goodwill
7,731
7,840
Other intangible assets
275
284
Other long term assets
2,565
2,580
Financial assets at amortized cost
284
284
12,646
12,801
Current assets
Cash and cash equivalents
113,056
54,031
Financial assets at amortized cost
39,698
-
R&D tax credit receivable
10,690
17,627
Other current assets
10,149
9,135
Trade receivables
8,140
228
181,733
81,021
Non-current liabilities
Contract liabilities
(56,208
)
(58,910
)
Lease liability
(93
)
(93
)
(56,301
)
(59,003
)
Current liabilities
Contract liabilities
(3,505
)
(5,161
)
Trade and other payables
(10,487
)
(12,429
)
Lease liability
(184
)
(179
)
(14,176
)
(17,769
)
Net assets
123,902
17,050
Capital and reserves attributable to the owners of the parent
Share capital
6,986
5,942
Capital reserves
420,759
313,769
Translation reserve
1,861
1,951
Accumulated losses
(305,704
)
(304,612
)
Total shareholders equity
123,902
17,050
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