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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 8, 2025

 

 

Silence Therapeutics plc

(Exact name of registrant as specified in its charter)

 

 

 

England and Wales
  001-39487
  Not Applicable
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)

 

72 Hammersmith Road

London

United Kingdom

  W14 8TH
(Address of principal executive offices)   (Zip Code)

+44 20 3457 6900

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading
Symbol(s)

 

Name of each exchange
on which registered

American Depositary Shares, each representing 3 ordinary shares, nominal value £0.05 per share   SLN   The Nasdaq Stock Market LLC
Ordinary share, nominal value £0.05 per share*   *   The Nasdaq Stock Market LLC

 

*

Not for trading, but only in connection with the listing of the American Depositary Shares on The Nasdaq Stock Market LLC.

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 
 


Item 2.02.

Results of Operations and Financial Condition.

On May 8, 2025, Silence Therapeutics plc (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2025, as well as recent business highlights. A copy of the press release is furnished as Exhibit 99.1 to this report and incorporated by reference.

The information in this Item 2.02 of this Current Report on 8-K, including Exhibits 99.1 hereto, is being furnished and 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 (the “Securities Act”), 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 references in such filing.

 

Item 9.01.

Financial Statements and Exhibits

(d) Exhibits.

 

Exhibit
No.
  

Description

99.1    Press Release dated May 8, 2025.
104    Cover Page Interactive Data File (embedded within the Inline XBRL document).

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    SILENCE THERAPEUTICS PLC
Dated: May 8, 2025     By:  

/s/ Craig Tooman

    Name:   Craig Tooman
    Title:   President and Chief Executive Officer (Principal Executive Officer)
EX-99.1 2 d932196dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

Silence Therapeutics Reports First Quarter 2025 Financial Results and Recent Business Highlights

Company further extends cash guidance into 2028

8 May 2025

LONDON, Silence Therapeutics plc, Nasdaq: SLN (“Silence” or “the Company”), a global clinical-stage company developing novel siRNA (short interfering RNA) therapies, today reported its financial results for the first quarter ended March 31, 2025, and reviewed recent business highlights.

“Silence delivered another strong quarter focused on clinical and operational execution,” said Craig Tooman, President and Chief Executive Officer at Silence. “We remain focused on advancing enrollment into the SANRECO Phase 2 study of divesiran, a first-in-class siRNA program in PV, and continue to be on-track to complete enrollment by the end of this year. We are also looking forward to sharing additional results from the Phase 1 portion of the SANRECO study during an oral presentation at EHA next month.”

Rhonda Hellums, Chief Financial Officer at Silence, added, “We ended the first quarter with over $136 million in cash, cash equivalents, and short-term investments. To maintain a healthy financial position while prioritizing the advancement of our core PV program, we are implementing cost savings initiatives and further extending our cash guidance into 2028. We remain committed to realizing the vast potential of our proprietary mRNAi GOLD™ platform and will continue to invest prudently in areas where we see the greatest opportunity to enhance value to Silence stakeholders.”

First Quarter 2025 & Recent Business Highlights

Divesiran for Polycythemia Vera (PV)

 

   

Additional Phase 1 results from the SANRECO study of divesiran in PV patients have been accepted for oral presentation during the European Hematology Association (EHA) 2025 Annual Congress being held in Milan, Italy from June 12 – 15, 2025.

 

   

Advanced patient enrollment into the Phase 2 portion of the SANRECO study of divesiran in PV patients and remain on-track to complete enrollment by year-end 2025.

Zerlasiran for Cardiovascular Disease

 

   

Advanced core Phase 3 readiness activities, including manufacturing and supply scale up, which remain on-track to complete by mid-2025. Partnering discussions for potential Phase 3 development are ongoing.

Collaborations

 

   

A Phase 1 study of SLN312 (licensed to AstraZeneca) is ongoing.

Corporate Updates

 

   

Appointed Tim McInerney to the Company’s Board of Directors, effective May 5, 2025. Mr. McInerney is a seasoned executive and board member with over 30 years of experience in both the investment and pharmaceutical industries.

First Quarter 2025 Financial Highlights

 

   

Cash Position: Cash and cash equivalents, and short-term investments of $136.5 million as of March 31, 2025, compared with $147.3 million as of December 31, 2024.


LOGO

 

   

R&D Expenses: Research and development (R&D) expenses were $20.8 million, an increase of $9.0 million compared to the first quarter of 2024. The increase was primarily due to the advancement of our clinical trials and an increase in manufacturing activities for our proprietary programs.

 

   

G&A Expenses: General and administrative (G&A) expenses were $7.7 million, an increase of $1.0 million compared to the first quarter of 2024. The increase is primarily due to the cost of additional reporting and compliance requirements in connection with our transition to becoming a domestic issuer and large accelerated filer.

 

   

Net Loss: Net loss was $28.5 million, or $0.20 basic and diluted net loss per share, compared to a net loss of $2.3 million, or $0.02 basic and diluted net loss per share for the first quarter of 2024.

 

   

Total ADSs outstanding were approximately 47,230,283 as of March 31, 2025.

Updates to 2025 Financial Guidance

 

   

Silence has implemented cost savings initiatives to strengthen its financial position and further extend its cash runway into 2028. These measures include general and administrative reductions, as well as further prioritizing early-stage research projects and resources. The Company remains committed to realizing the vast potential of its proprietary mRNAi GOLD™ platform and will continue to invest prudently in key areas focused on enhancing value to Silence stakeholders.

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: the Company’s business strategy and plans, including the Company’s clinical development activities and timelines; the progression and advancement of collaborations; the expected benefits of the Company’s cost saving initiatives; the Company’s ability to enhance stakeholder value; and the Company’s anticipated extended cash runway. 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.


LOGO

 

Inquiries:

 

Silence Therapeutics plc

Gem Hopkins, VP, IR and Corporate Communications

ir@silence-therapeutics.com

   Tel: +1 (646) 637-3208


LOGO

 

Silence Therapeutics plc

Condensed Consolidated Balance Sheets

(Unaudited, in thousands, except share and per share data)

 

     Period ended  
     March 31,
2025
    December 31,
2024
 
Current assets     

Cash and cash equivalents

   $ 64,886     $ 121,330  

Short-term investments

     71,648       26,004  

R&D benefit receivable

     16,796       24,396  

Other current assets

     16,419       14,664  

Trade receivables

     41       972  
  

 

 

   

 

 

 
Total current assets      169,790       187,366  

Property, plant and equipment

     1,693       1,818  

Operating lease right-of-use assets

     107       157  

Goodwill

     9,784       9,392  

Other intangible assets

     310       312  

Other long-term assets

     3,614       3,590  
  

 

 

   

 

 

 
Total assets    $ 185,298     $ 202,635  
  

 

 

   

 

 

 
Current liabilities     

Contract liabilities

   $ (392   $ (306

Trade and other payables

     (18,812     (16,399

Operating lease liabilities, current

     (60     (117
  

 

 

   

 

 

 
Total current liabilities      (19,264     (16,822

Contract liabilities

     (53,291     (51,790
  

 

 

   

 

 

 
Total liabilities    $ (72,555   $ (68,612
  

 

 

   

 

 

 

Commitments and contingencies (Note 20)

    
Shareholders’ equity     

Ordinary shares - par value £0.05 per share; 141,690,850 shares issued at March 31, 2025 (December 31, 2024: 141,674,074)

     (10,289     (10,288

Additional paid-in capital

     (613,074     (609,560

Accumulated deficit

     502,536       474,044  

Accumulated other comprehensive loss

     8,084       11,781  
  

 

 

   

 

 

 
Total shareholders’ equity      (112,743     (134,023
  

 

 

   

 

 

 

Total liabilities and shareholders’ equity

   $ (185,298   $ (202,635
  

 

 

   

 

 

 


LOGO

 

Silence Therapeutics plc

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited, in thousands, except share and per share data)

 

     Three months ended March 31,  
     2025     2024  

Revenue

   $ 142     $ 15,699  

Cost of sales

     (54     (2,800
  

 

 

   

 

 

 

Gross profit

     88       12,899  

Research and development costs

     (20,813     (11,845

General and administrative expenses

     (7,684     (6,635
  

 

 

   

 

 

 

Operating loss

     (28,409     (5,581

Foreign currency (loss)/gain, net

     (3,769     351  

Other income, net

     969       667  

Benefit from R&D credit

     2,679       2,495  
  

 

 

   

 

 

 

Loss before income tax expense

     (28,530     (2,068
  

 

 

   

 

 

 

Income tax expense

     —        (244
  

 

 

   

 

 

 

Net Loss

   $ (28,530   $ (2,312
  

 

 

   

 

 

 

Loss per share (basic and diluted)

   $ (0.20   $ (0.02