UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 6-K

 

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

April 2021

 

 

 

Commission File Number:  0001723069

 

 

 

Tiziana Life Sciences plc

(Exact Name of Registrant as Specified in Its Charter)

 

 

 

3rd Floor,

11-12 St James’s Square

London SW1Y 4LB

United Kingdom

(Address of registrant’s principal executive office)

 

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F ☒  Form 40-F ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

 

 

 

 

 

 

INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K

 

On April 13, 2021, Tiziana Life Sciences plc (the “Company”) issued a regulatory news service announcement in the United Kingdom announcing Plans to List Accustem Sciences Limited in the U.S. (the “RNS Announcement”).

 

The RNS Announcement is furnished herewith as Exhibit 99.1 to this Report on Form 6-K. The information in the attached Exhibit 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.

 

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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, thereunto duly authorized.

 

  TIZIANA LIFE SCIENCES PLC
       
Date: April 13, 2021 By: /s/ Kunwar Shailubhai
    Name:  Kunwar Shailubhai
    Title: Chief Executive Officer

 

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EXHIBIT INDEX

 

Exhibit No.  Description
    
99.1  Regulatory News Service Announcement, dated April 13, 2021

 

 

3

 

 

Exhibit 99.1

 

Tiziana Life Sciences plc

 

(“Tiziana” or the “Company”)

 

Tiziana Life Sciences plc Announces Plans to List Accustem Sciences Limited in the U.S.

 

NEW YORK and LONDON, April 13, 2021 - Tiziana Life Sciences plc (NASDAQ: TLSA; LSE: TILS), today announced that its former subsidiary, Accustem Sciences Limited (“Accustem”), intends to file a listing application with the Nasdaq Stock Market shortly after completion of the distribution of shares in Accustem to Tiziana Life Sciences plc shareholders.

 

The board of directors of Accustem has resolved that the Nasdaq listing venue is more appropriate to the nature of Accustem’s business.

 

About Accustem Sciences

 

StemPrintER is a multi-gene prognostic assay intended to predict the risk of recurrence of R+/HER2- breast cancer, and Spare, a derivative of StemPrintER, combines StemPrintER with two clinical markers. This gives a more refined risk model.

 

These assays are intended for the prediction of the risk of recurrence of breast cancer, based on the detection of 20 stem cell markers. The assay has been evaluated in an initial retrospective validation study using a consecutive cohort of approximately 2,400 patients with breast cancer. Subsequently, StemPrintER has been further validated in an independent retrospective cohort of more than 800 ER+/HER2- postmenopausal patients from the TransATAC trial.

 

A poster presented at the American Society of Clinical Oncology (ASCO) Virtual Conference in May 2020, demonstrated the superiority of StemPrintER stem cell based genomic prognostic tool versus the market leader, Oncotype DX, in predicting recurrence in ER+/HER2- postmenopausal breast cancer patients.

 

Endocrine receptor-positive (ER+) breast cancers make up most breast cancer cases, however display significant variability in clinical behaviour, this makes prognosis and therapy response challenging. Although the overall prognosis of patients is good, a significant proportion of these women will experience distant recurrence in the first 10 years post-surgery.

 

For patients who also have a negative HER2 status (HER2-) and risk of recurrence, the standard of care is endocrine therapy, with the addition of chemotherapy in patients. However, these parameters are often insufficient to predict risk of recurrence in ER+/HER2- breast cancer patients, and consequently, these patients are either over- or under-treated.

 

Accustem anticipates this prognostic test to be used in conjunction with clinical evaluation to identify those patients at increased risk for early and/or late metastasis.

 

For further enquiries:

 

United Kingdom Investors:

 

Tiziana Life Sciences plc (TLSA)

 

Gabriele Cerrone, Chairman and founder +44 (0)20 7495 2379

 

U.S. Investor Relations Contact:

 

RedChip Companies, Inc.

 

Dave Gentry

 

407-491-4498

 

dave@redchip.com