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 third quarter ended September 30, 2022 and reviewed recent business highlights.
“Silence’s third quarter was one of strong execution across our business,” said Craig Tooman, President and Chief Executive Officer of Silence. “We strengthened our balance sheet in August and made excellent progress advancing our pipeline programs. We’re looking forward to initiating the SLN360 phase 2 study in ASCVD and the SLN124 phase 1/2 study in PV.”
Third Quarter 2022 & Recent Highlights
mRNAi GOLD™ Proprietary Program Updates
SLN360 (cardiovascular disease)
-
Presented a new analysis from the APOLLO phase 1 single dose study of SLN360 in healthy adults with high lipoprotein(a), a key genetic risk factor for cardiovascular disease, in a moderated poster session at the American Heart Association (“AHA”) 2022 Annual Meeting.
- Assessment showed participants who received a single dose of SLN360 maintained median Lp(a) reductions over 80% over a five-month period. Additionally, extension data to day 365 showed no new drug related safety findings.
SLN124 (hematological diseases)
-
Reported preliminary single dose results from the GEMINI II phase 1 study of SLN124 in non-transfusion dependent thalassemia patients.
- Data showed no serious adverse events (“AEs”), no severe treatment emergent AEs that were SLN124 related and no TEAEs leading to withdrawal.
- No dose limiting toxicity or drug related liver injury was observed.
- Received FDA Fast Track Designation for SLN124 for the treatment of polycythemia vera (PV).
Anticipated Milestones
- SLN360 phase 2 study in patients with atherosclerotic cardiovascular disease (“ASCVD”) and high Lp(a) expected to start in the fourth quarter of 2022.
- SLN124 phase 1/2 study in PV patients expected to start in the fourth quarter of 2022.
Third Quarter 2022 Financial Results
For the three-month period ending September 30, 2022, the net loss after tax was £7.1 million, or weighted average loss per share of 7.2 pence, compared to a loss of £9.9 million, or weighted average loss per share of 11.1 pence, for the same period in 2021. For the nine-month period ending September 30, 2022, the net loss after tax was £26.7 million, or weighted average loss per share of 28.8 pence, compared to £30.0 million, or weighted average loss per share of 33.8 pence, for the same period in 2021. The decrease in net loss was primarily related to increase in revenues from our collaboration agreements as we continue to further advance the programs.
On August 11, 2022 the Group announced a registered direct offering (“Offering”) of 5,950,000 of the Company’s ADSs, each representing three ordinary shares, at a price of $9.50 per ADS, with new and existing institutional and accredited investors. The aggregate gross proceeds of the Offering was $56.5 million (approximately £46.4 million) before deducting $4.1 million (approximately £3.3 million) in placement agent fees and other expenses.
Revenue
Revenue recognized for the three months period ending September 30, 2022 grew by £0.2 million to £3.4 million from £3.2m in the same period in 2021. For the nine-month period ending September 30, 2022, revenue grew by £3.7 million from £9m in the same period in 2021. The growth is a result of the further advancement of the partner programs. During the first nine-months ended September 30, 2022, two additional milestones for a total of $5 million were achieved and received.
Cost of sales
Cost of sales increased £0.3 million for the three months ended September 30, 2022, as compared to the same period in 2021. For the nine months ended September 30, 2022 cost of sales increased £1.6 million. This was mainly due to increased activity associated with our collaboration agreements.
Research and Development
Research and development expenditure for the three months ended September 30, 2022 were £8.8 million compared to £7.9 million for the same three month period ending September 30, 2021. Research and development expenditures for the nine months ending September 30, 2022 was £27.2 million (nine months ended September 30,2021: £23.5 million). This was due to an increase in contracted research and development expenses resulting from advancement of studies for SLN124 and SLN360.
General and Administrative
General and administrative expenses for the three-month period ended September 30, 2022 increased by £0.4 million to £5.8 million from £5.5 million for the same corresponding period in 2021. For the nine-month period ended September 30, 2022, general and administrative expenses increased £1.5 million as compared to the same period in 2021 primarily due to the growth of the organization and continued public company requirements.
Liquidity, cash and cash equivalents
As of September 30, 2022, the Company had cash and cash equivalents of £90.0 million (approximately $113.3 million). In August 2022 the Company raised additional funds through a registered direct offering with aggregate gross proceeds of $56.5 million (approximately £46.4 million) before deducting $4.1 million (approximately £3.3 million) in placement agent fees and other expenses. During the year, the Company received two financial milestones from our existing collaboration agreements totaling $5 million.
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 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 SLN124 designed to address rare 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 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 '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 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 (the “SEC”) on March 17, 2022. 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 |
|
|
Nine months ended |
|
|
Nine months ended |
|
|
|
September 30, 2022 |
|
|
September 30, 2021 |
|
|
September 30, 2022 |
|
|
September 30, 2021 |
|
|
£000s (except per share information) |
'£000s |
|
|
'£000s |
|
|
'£000s |
|
|
'£000s |
|
|
Revenue |
3,371 |
|
|
3,156 |
|
|
12,736 |
|
|
9,001 |
|
|
Cost of sales |
(2,394 |
) |
|
(2,052 |
) |
|
(7,021 |
) |
|
(5,414 |
) |
|
Gross profit |
977 |
|
|
1,104 |
|
|
5,715 |
|
|
3,587 |
|
|
Research and development expenses |
(8,771 |
) |
|
(7,916 |
) |
|
(27,206 |
) |
|
(23,541 |
) |
|
General and administrative expenses |
(5,827 |
) |
|
(5,472 |
) |
|
(16,141 |
) |
|
(14,597 |
) |
|
Operating loss |
(13,621 |
) |
|
(12,284 |
) |
|
(37,632 |
) |
|
(34,551 |
) |
|
Finance and other expenses |
(34 |
) |
|
(64 |
) |
|
(34 |
) |
|
(86 |
) |
|
Finance and other income |
4,329 |
|
|
296 |
|
|
5,348 |
|
|
8 |
|
|
Loss for the period before taxation |
(9,326 |
) |
|
(12,052 |
) |
|
(32,318 |
) |
|
(34,629 |
) |
|
Taxation |
2,223 |
|
|
2,123 |
|
|
5,592 |
|
|
4,653 |
|
|
Loss for the period after taxation |
(7,103 |
) |
|
(9,929 |
) |
|
(26,726 |
) |
|
(29,976 |
) |
|
Loss per ordinary equity share (basic and diluted) |
(7.2) pence |
|
|
(11.1) pence |
|
|
(28.8) pence |
|
|
(33.8) pence |
|
|
Condensed consolidated balance sheet (unaudited)
|
|
September 30, 2022 |
|
|
December 31, 2021 |
|
|
|
£000s |
|
|
£000s |
|
Non-current assets |
|
|
|
|
|
|
Property, plant and equipment |
|
2,319 |
|
|
1,944 |
|
Goodwill |
|
7,958 |
|
|
7,592 |
|
Other intangible assets |
|
20 |
|
|
24 |
|
Financial assets at amortized cost |
|
284 |
|
|
301 |
|
|
|
10,581 |
|
|
9,861 |
|
Current assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
90,017 |
|
|
73,537 |
|
R&D tax credit receivable |
|
12,966 |
|
|
6,945 |
|
Other current assets |
|
10,343 |
|
|
5,520 |
|
Trade receivables |
|
130 |
|
|
331 |
|
|
|
113,456 |
|
|
86,333 |
|
Non-current liabilities |
|
|
|
|
|
|
Contract liabilities |
|
(63,973 |
) |
|
(72,501 |
) |
|
|
(63,973 |
) |
|
(72,501 |
) |
Current liabilities |
|
|
|
|
|
|
Contract liabilities |
|
(10,624 |
) |
|
(4,247 |
) |
Trade and other payables |
|
(14,810 |
) |
|
(10,783 |
) |
Lease liability |
|
(499 |
) |
|
(137 |
) |
|
|
(25,933 |
) |
|
(15,167 |
) |
Net(liabilities)/assets |
|
34,131 |
|
|
8,526 |
|
Capital and reserves attributable to the owners of the parent |
|
|
|
|
|
|
Share capital |
|
5,384 |
|
|
4,489 |
|
Capital reserves |
|
276,163 |
|
|
225,462 |
|
Translation reserve |
|
2,228 |
|
|
1,541 |
|
Accumulated losses |
|
(249,644 |
) |
|
(222,966 |
) |
Total shareholders (deficit)/equity |
|
34,131 |
|
|
8,526 |
|
