Item 7.01 Regulation FD Disclosure. On August 10, 2026, Silence Therapeutics plc (the “Company”) issued a press release announcing positive topline results from the Phase 2 SANRECO trial of divesiran in polycythemia vera (“PV”). A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.…
Filed Aug 10, 2026Accepted Aug 10, 2026, 7:57 AM EDTCIK 1479615Accession 0001193125-26-341293
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/.
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Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On August 10, 2026, Silence Therapeutics plc (the “Company”) issued a press release announcing positive topline results from the Phase 2 SANRECO trial of divesiran in polycythemia vera (“PV”). A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
As described in the accompanying press release, the Company will host a conference call and live audio webcast today, August 10, 2026 at 8:00 a.m., Eastern Time, to discuss the presentation of data described above.
The live audio webcast may be accessed through the “Events and Presentations” section of the Company’s website at silence-therapeutics.com. A copy of the presentation to be used by the Company during the conference call is furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.
The Company’s website and any information contained on the Company’s website are not incorporated into this Current Report on Form 8-K.
Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events.
On August 10, 2026, the Company issued a press release announcing positive topline results from the Phase 2 SANRECO trial, a 36-week, randomized, double-blind, placebo-controlled portion of the Phase 2 trial evaluating divesiran (6 mg/kg) administered subcutaneously every six weeks (“Q6W”) or every twelve weeks (“Q12W”) met its primary endpoint and secondary endpoints. Based on the Phase 2 results, the Company expects to initiate a Phase 3 trial evaluating divesiran for Q12W dosing vs. placebo in the first half of 2027.
Key findings from the study include:
The primary endpoint was met, with a significantly higher proportion of clinical responders among divesiran-treated patients with PV compared to those who received placebo (88% for divesiran versus 19% for placebo; p<0.0001). The primary endpoint was the proportion of patients achieving a response, which was defined as the absence of phlebotomy and maintenance of hematocrit (HCT) below 45% during weeks 18-36.
Importantly, both divesiran dose groups showed substantial primary endpoint efficacy with response rates of 93.8% and 81.3% for Q6W and Q12W, respectively.
The key secondary endpoint of phlebotomy rate during weeks 0-36 was also met with the mean number of phlebotomies per patient in the divesiran groups significantly reduced compared to placebo (0.2 for divesiran versus 2.1 for placebo; p<0.0001).
Divesiran groups also showed improvements in hematocrit control, iron markers including ferritin, and patient reported outcomes using the MPN-SAF Total Symptom Score (MPN-SAF TSS).
Divesiran was observed to be well tolerated and safety was in line with previous trials. No new safety findings were observed in the trial. Injection site reactions were infrequent and self-limiting. There were two investigator reported grade 1 anemia adverse event cases.
Cautionary Regarding Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of hereof, and involve certain risks and uncertainties. Forward-looking statements include, but are not limited to, statements herein with respect to the timing and the Company’s ability to initiate Phase 3 trial of divesiran in PV. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, the factors that are described under the caption “Risk Factors” in the Company’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 5, 2026, and its subsequent filings with the SEC. The forward-looking statements herein are based on information available to the Company as of the date hereof, and the Company disclaims any obligation to update any forward looking statements, except as required by law.
Filed exhibits (2)
EX-99.1 (by filename) d12947dex991.htm
EX-99.1
2
d12947dex991.htm
EX-99.1
EX-99.1
Exhibit 99.1
Silence Therapeutics Announces Positive Topline Results from Phase 2 SANRECO
Trial of Divesiran in Polycythemia Vera, Supporting its
Potential Best-in-Class Profile
Trial met its primary endpoint, with a significantly higher proportion of clinical responders on divesiran
(88%) compared to placebo (19%); placebo-adjusted response rate = 69%
Both divesiran dose groups showed substantial primary endpoint efficacy; 93.8% response rate at Q6W and 81.3%
response rate at Q12W
Divesiran was observed to be well tolerated with no new safety findings
Phase 3 PV trial evaluating divesiran Q12W vs. placebo anticipated to initiate in 1H’27
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Investor conference call and webcast to be held today, August 10, 2026 at 8:00 a.m. ET
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10 August 2026
LONDON, Silence
Therapeutics plc (Nasdaq: SLN), a global clinical-stage biotechnology company developing novel siRNA (short interfering RNA) therapies, today announced positive topline results f…
EX-99.2
3
d12947dex992.htm
EX-99.2
EX-99.2
August 10, 2026 SANRECO Phase 2
Topline Results in Polycythemia Vera Exhibit 99.2
Forward-Looking Statements The
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