Silence Therapeutics Reports First Quarter 2024 Results and Highlights Pipeline Progress

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 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 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

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20240516057102/en/

Inquiries:

Silence Therapeutics plc Gem Hopkins, VP, IR and Corporate Communications [e-mail] Tel: [phone]