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4週前
Silence Therapeutics Highlights Follow-Up Data at EHA 2026 Demonstrating Durable Efficacy and Potential Best-in-Class Profile for Divesiran in Polycythemia VeraJune 11, 2026 7:30 AM
Business Wire New analyses from the Phase 1 SANRECO study demonstrate potential improvements in PV symptoms and quality-of-life Follow-up data show substantial reductions in phlebotomy use persisting after final dose Phase 2 SANRECO study evaluating Q6W and Q12W dosing remains on-track for topline results in August 2026 Silence Therapeutics plc (Nasdaq: SLN), a global clinical-stage biotechnology company developing novel siRNA (short interfering RNA) therapies, today presented follow-up and quality-of-life data from the Phase 1 SANRECO study evaluating divesiran, a first-in-class siRNA therapy targeting TMPRSS6, in 21 phlebotomy-dependent patients with polycythemia vera (PV) at the European Hematology Association (EHA) 2026 Annual Congress. Divesiran data presented at EHA show improvements in PV-related symptoms and quality-of-life, complementing the substantial reductions in phlebotomy use as previously reported. Additional analyses also showed substantial reductions in phlebotomy use persisted well beyond the final dose. “Data presented at EHA continue to reinforce divesiran’s potential to transform the treatment paradigm for patients with polycythemia vera,” said Curtis Rambaran, MD, Chief Medical Officer at Silence Therapeutics. “In Phase 1, we observed sustained hematocrit control, symptom improvement, and robust and durable reductions in phlebotomy burden, which persisted after the final dose. These findings further support the potential for less frequent dosing, including the Q12W regimen being evaluated in our ongoing Phase 2 SANRECO study, and we look forward to reporting topline results in August 2026.” Key EHA 2026 Data Highlights In the six months prior to treatment, the 21 enrolled patients required a total of 80 phlebotomies. During the active treatment period, only 5 phlebotomies were required, all occurring in patients classified as “uncontrolled” at baseline with HCT levels greater than 45%. During the 16-week follow-up period after the final dose, only 4 phlebotomies were reported, supporting the prolonged duration of divesiran’s effect. Among 14 patients with further follow-up data, the median time to first phlebotomy was 287 days. The majority of patients experienced improvements in MPN-10 total symptom scores from baseline through Week 34, indicating potential improvements in disease-related symptoms and overall quality of life. Divesiran was well tolerated, with no dose-limiting toxicities observed. The most common treatment-emergent adverse events (TEAEs) were mild and transient injection-site reactions. No treatment-related serious adverse events or TEAEs leading to discontinuation were reported. The 2026 EHA poster presentation is linked here. The ongoing Phase 2 SANRECO study (NCT05499013) is evaluating divesiran using Q6W and Q12W dosing regimens in patients with PV. Topline data are expected in August 2026. SANRECO Phase 1 Study Design
The Phase 1 portion of SANRECO was a 34-week, open-label study evaluating divesiran (3 mg/kg, 6 mg/kg and 9 mg/kg) administered subcutaneously (s.c.) Q6W for four doses, with a 16-week follow-up period following the date of the last administered dose in 21 PV patients. Key inclusion criteria included a PV diagnosis and a history of requiring at least three phlebotomies in the last six months or five in the last year prior to screening. Patients were allowed to be on stable doses of cytoreductive agents. Given the exploratory nature of this Phase 1 study, both well-controlled patients - defined as those with HCT levels ≤ 45% – as well as those with HCT levels > 45% at baseline on current standard-of-care treatment were enrolled. SANRECO Phase 2 Study Design
The Phase 2 portion of SANRECO is an ongoing, three-part, global, randomized, placebo-controlled, double-blind study evaluating divesiran in 48 phlebotomy-dependent PV patients. The trial is evaluating the safety and efficacy of divesiran 6 mg administered s.c. Q6W or Q12W in patients with uncontrolled HCT who are phlebotomy-dependent despite standard-of-care treatment which could include hydroxyurea, interferon and/or ruxolitinib. The primary endpoint of the study is the proportion of patients achieving a response during weeks 18-36, which is defined as the absence of “phlebotomy eligibility.” To meet phlebotomy eligibility, patients in the study are required to have HCT ≥ 45%. Following the placebo-controlled portion of the trial, patients enter the 3-year, double-blind and open label extension periods. About PV
PV is a rare, myeloproliferative neoplasm – a type of blood cancer - characterized by the excessive production of red blood cells, often resulting in elevated hematocrit levels. Elevated hematocrit above 45-percent is associated with a four-times higher rate of death from cardiovascular and thrombotic events. PV is associated with a range of burdensome symptoms including fatigue, cognitive disturbance and pruritus and additionally, longer term can transform to myelofibrosis and Acute Myeloid Leukemia. The aim of treatment is to maintain hematocrit less than 45%, a level that is associated with a reduced incidence of thrombosis and CV-associated death. The current standard of care includes repeated phlebotomies to reduce hematocrit and/or cytoreductive agents to reduce red blood cell production. There are currently no approved therapies that specifically target red blood cells and hematocrit. About Divesiran
Divesiran is Silence’s wholly owned siRNA product candidate developed from its proprietary mRNAi GOLD™ platform that “silences” TMPRSS6 expressed almost exclusively in the liver. TMPRSS6 is a negative regulator of hepcidin, the body's master regulator of iron metabolism including its absorption, distribution, and storage. By silencing TMPRSS6 in PV patients, divesiran aims to increase hepcidin production and release by liver hepatocytes, leading to the restriction of iron to the bone marrow and, thus, reducing the excessive production of red blood cells, a process dependent on availability of iron. Divesiran is currently in Phase 2 development for PV and has FDA Fast Track and Orphan Drug designations for PV. About Silence Therapeutics
Silence Therapeutics is a global clinical-stage biotechnology company committed to transforming people’s lives by silencing diseases through precision engineered medicines created with proprietary siRNA (short interfering RNA) technology. Silence leverages its mRNAi GOLD™ platform to create innovative siRNAs designed to precisely target and silence disease-associated genes in the liver, which represents a substantial opportunity. Silence focuses on areas of high unmet medical need with programs advancing in cardiovascular disease, hematology and rare diseases. For more information, please visit https://www.silence-therapeutics.com/. Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: continued clinical development of divesiran including the proposed SANRECO Phase 2 clinical activities and timelines; the potential therapeutic benefits of the Company’s product candidates; and the anticipated timing of topline and future results from the SANRECO Phase 2 trial. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the company’s history of net operating losses; the company’s ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company’s product candidates; the company’s ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company’s product candidates; the company’s reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company’s ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled “Risk Factors” contained in the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company’s other filings with the SEC. Any forward-looking statements that the Company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. View source version on businesswire.com: https://www.businesswire.com/news/home/20260611005104/en/ Inquiries: Silence Therapeutics plc
Gem Hopkins, VP, Head of IR and Corporate Communications
+1 (646) 637-3208
ir@silence-therapeutics.com Media Relations
MKC Strategies
Mary Conway
+1 (516) 606-6545
mconway@mkcstrategies.com Original: Silence Therapeutics Highlights Follow-Up Data at EHA 2026 Demonstrating Durable Efficacy and Potential Best-in-Class Profile for Divesiran in Polycythemia Vera
US Market News
4月前
Silence Therapeutics Highlights Recent Business Achievements and Reports Fourth Quarter and Full Year 2025 Financial ResultsMarch 5, 2026 7:30 AM
Business Wire
Topline results for Phase 2 SANRECO trial of divesiran, a first-in-class siRNA for polycythemia vera (PV), on-track for third quarter of 2026
Silence Therapeutics plc, Nasdaq: SLN, a global clinical-stage company developing novel siRNA (short interfering RNA) therapies, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided an update on recent business achievements.
“The past year was focused on clinical execution, demonstrated by the expedited enrollment in the Phase 2 SANRECO trial of divesiran in PV which is on-track for topline results in third quarter of 2026,” said Iain Ross, Chairman and Interim Principal Executive Officer at Silence. “Divesiran is a first-in-class siRNA product candidate in PV with broad potential in blood disorders and this program is our highest priority. We believe we are well positioned today with excellent optionality and multiple near-term value drivers ahead.”
Business Highlights
Divesiran: First-in-class siRNA for PV
Accelerated timing for topline results in the Phase 2 SANRECO trial of divesiran, a first-in-class siRNA for PV; now anticipated in 3Q’26 (formerly 2H’26) due to faster than expected enrollment.
Zerlasiran: Phase 3 ready program for cardiovascular disease due to high Lp(a)
Completed core Phase 3 readiness activities; program is well positioned for a potential third-party partner to initiate Phase 3 development.
SLN312: Phase 1 siRNA with a competitive profile for dyslipidemia
AstraZeneca shared results from an interim analysis of a Phase 1 randomized, single-blind, placebo-controlled trial of SLN312, an siRNA silencing ANGPTL3 discovered using Silence’s mRNAi GOLD™ platform and developed by AstraZeneca, in 98 patients with dyslipidemia. Data highlights include:
SLN312 demonstrated durable dose-dependent reductions in ANGPTL3, triglycerides and atherogenic lipoproteins after single and multiple doses.
Strong durability profile observed supporting potential for infrequent dosing.
SLN312 was well tolerated with no safety concerns identified.
Phase 1 data presentations are planned for medical and research congresses in 2026.
On March 4, 2026, AstraZeneca notified Silence that they will not pursue further development of SLN312 beyond Phase 1. Silence will re-gain exclusive rights globally to this clinical asset following Phase 1 and is evaluating plans for further development. AstraZeneca and Silence maintain a broader collaboration leveraging Silence's mRNAi GOLD™ platform for cardiovascular, cardiometabolic, renal and respiratory diseases.
Discovery Pipeline
Generated promising preclinical data for two new mRNAi GOLD™ platform programs.
SLN365, a potential first-in-class siRNA silencing GPR146, a novel mechanism-of-action for cholesterol management independent of LDL-C receptor function.
SLN098, an siRNA silencing INHBE, a novel target for obesity supported by human genetics and strong pre-clinical data.
Advanced extra-hepatic cell targeting leveraging the Company’s proprietary siRNA platform, generating promising preliminary results in several cell types.
Anticipated 2026 Milestones
Topline results for Phase 2 SANRECO trial of divesiran in PV in third quarter of 2026.
Additional preclinical data for SLN365 (GPR146) in second quarter of 2026.
Additional preclinical data for SLN098 (INHBE) in second quarter of 2026.
Phase 1 data presentations for SLN312 at medical and research congresses in 2026.
Corporate Updates
On December 15, 2025, Iain Ross, Chairman of the Board of Directors, was announced as Interim Principal Executive Officer following the departure of the Company’s former CEO; a search is underway for a new CEO.
In December 2025, James Ede Golightly, a former Silence Non-Executive Director, was reappointed to the Board. Additionally, Rhonda Hellums, CFO of Silence, was appointed to the Board as an Executive Director.
Full Year 2025 Financial Results
Cash Position: Cash, cash equivalents, and short-term investments were $85.1 million as of December 31, 2025. This includes cash and cash equivalents of $11.3 million and short-term investments of $73.8 million.
Collaboration Revenue: Collaboration revenue was $0.6 million for the year ended December 31, 2025, compared to $43.3 million for the year ended December 31, 2024. The decrease for 2025 was primarily due to revenue associated with the Hansoh collaboration that concluded in 2024 and a $17.4 million decrease in revenue related to the AstraZeneca collaboration.
R&D Expenses: Research and development (R&D) expenses were $67.8 million for the year ended December 31, 2025, compared to $67.9 million for the year ended December 31, 2024.
G&A Expenses: General and administrative (G&A) expenses were $22.3 million for the year ended December 31, 2025, compared to $26.9 million for the year ended December 31, 2024. The decrease for 2025 was primarily a result of a decrease in SEC reporting requirements and other cost-savings initiatives.
Net Loss: Net loss was $88.6 million, or $0.63 basic and diluted net loss per share for the year ended December 31, 2025, compared to a net loss of $45.3 million, or $0.33 basic and diluted net loss per share for the year ended December 31, 2024.
Total outstanding shares were 141,701,848 ordinary shares (including shares in the form of American Depositary Shares) as of December 31, 2025.
About Silence Therapeutics
Silence Therapeutics is a global clinical-stage biotechnology company committed to transforming people’s lives by silencing diseases through precision engineered medicines created with proprietary siRNA (short interfering RNA) technology. Silence leverages its mRNAi GOLD™ platform to create innovative siRNA therapies designed to precisely target and silence genes that cause disease. The Company is advancing a growing pipeline of siRNA product candidates targeting areas of high unmet need across rare and common diseases where treatments are limited or inadequate. For more information, please visit https://www.silence-therapeutics.com/.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements about: the Company’s business strategy and plans, including the Company’s clinical development activities and timelines; the potential therapeutic benefits of the Company’s product candidates; the anticipated timing of initial topline and future results from the SANRECO Phase 2 trial; the Company’s ability to deliver near- or long-term value; the Company’s ability to advance additional candidates from its mRNAi GOLD™ platform; the Company’s ability to advance extra-hepatic cell targeting or identify extra-hepatic product candidates; and the Company’s ability to identify and engage potential third-party partners for one or more of its product candidates, including the Company’s preclinical and Phase 3 ready assets. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the company’s history of net operating losses; the company’s ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company’s product candidates; the company’s ability to obtain regulatory approval of and successfully commercialize its product candidates either on its own or with potential partners; any undesirable side effects or other properties of the company’s product candidates; the company’s reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company’s ability to adequately maintain intellectual property rights for its product candidates. These and other risks are described in greater detail under the section titled “Risk Factors” contained in the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company’s other filings with the SEC. Any forward-looking statements that the Company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
SILENCE THERAPEUTICS plc
Consolidated Statements of income (loss)
(in thousands, except for loss per share and share data)
Year ended December 31,
Note
2025
2024
Revenue
3
$
559
$
43,258
Cost of sales
(215
)
(11,810
)
Gross profit
344
31,448
Research and development costs
(67,753
)
(67,883
)
General and administrative expenses
(22,344
)
(26,884
)
Restructuring charges
6
(1,324
)
-
Operating loss
(91,077
)
(63,319
)
Foreign currency (loss)/gain, net
(8,467
)
646
Other income, net
7
3,480
4,472
Benefit from R&D credit
7,463
13,737
Loss before income tax expense
(88,601
)
(44,464
)
Income tax expense
18
(11
)
(845
)
Net Loss
$
(88,612
)
$
(45,309
)
Loss per share (basic and diluted)
8
$
(0.63
)
$
(0.33
)
Weighted average shares outstanding
(basic and diluted)
141,694,702
138,752,224
The accompanying notes form an integral part of these consolidated financial statements.
SILENCE THERAPEUTICS plc
Consolidated balance sheets
(in thousands, except share data)
Year ended December 31,
Note
2025
2024
Current assets
Cash and cash equivalents
12
$
11,277
$
121,330
Short-term investments
12
73,837
26,004
R&D benefit receivable
22,007
24,396
Other current assets
13
11,537
14,664
Trade receivables
14
-
972
Total current assets
118,658
187,366
Property, plant and equipment, net
9
1,581
1,818
Operating lease right-of-use assets
16
167
157
Goodwill
10
10,621
9,392
Intangible assets
11
288
312
Other long-term assets
13
127
3,590
Total assets
$
131,442
$
202,635
Current liabilities
Contract liabilities
17
$
(168
)
$
(306
)
Trade and other payables
15
(13,356
)
(16,399
)
Operating lease liabilities, current
16
(89
)
(117
)
Total current liabilities
(13,613
)
(16,822
)
Contract liabilities
17
(55,454
)
(51,790
)
Operating lease liabilities, long-term
16
(71
)
-
Total liabilities
$
(69,138
)
$
(68,612
)
Commitments and contingencies (Note 21)
Shareholders’ equity
Ordinary shares - par value £0.05 per share; 141,701,848 shares issued at December 31, 2025 (2024: 141,674,074)
19
(10,290
)
(10,288
)
Additional paid-in capital
(617,562
)
(609,560
)
Accumulated deficit
562,572
474,044
Accumulated other comprehensive loss
2,976
11,781
Total shareholders' equity
(62,304
)
(134,023
)
Total liabilities and shareholders' equity
$
(131,442
)
$
(202,635
)
The accompanying notes form an integral part of these consolidated financial statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260305236008/en/
Inquiries:
Silence Therapeutics plc
Gem Hopkins, VP, IR and Corporate Communications
ir@silence-therapeutics.com
Tel: +1 (646) 637-3208
Original: Silence Therapeutics Highlights Recent Business Achievements and Reports Fourth Quarter and Full Year 2025 Financial Results
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