SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
Commission File Number: 0001723069
Tiziana Life Sciences plc
(Exact Name of Registrant as Specified in Its Charter)
11-12 St James’s Square
London SW1Y 4LB
(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 May 11, 2020, Tiziana Life Sciences plc (the “Company”) issued a regulatory news service announcement in the United Kingdom announcing that Tiziana Life Sciences is to present two studies featuring StemPrintER, a stem cell biology-based Breast Cancer Prognostic Tool during the American Society of Clinical Oncology (ASCO) Virtual Conference (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.
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: May 11, 2020||By:||/s/ Kunwar Shailubhai|
|Title:||Chief Executive Officer|
|99.1||Regulatory News Service Announcement, dated May 11, 2020|
Tiziana Life Sciences plc
(“Tiziana” or the “Company”)
Tiziana Life Sciences to present two studies featuring StemPrintER, a stem cell biology-based Breast Cancer Prognostic Tool during the American Society of Clinical Oncology (ASCO) Virtual Conference
Two additional abstracts featuring Milciclib in treating Hepatocellular Carcinoma to be published online
New York/London – May 11, 2020 – Tiziana Life Sciences plc (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for inflammatory and autoimmune diseases, announces that two abstracts on the Company’s stem cell biology-based genomic tool, StemPrintER, for the prediction of disease recurrence in breast cancer patients, will be presented at the American Society of Clinical Oncology’s 2020 Virtual Conference. All abstracts, including Abstract #1020, which compares Tiziana’s product to current market leader Oncotype DX as part of a poster discussion session, will be available online beginning May 13, 2020 beginning at 5:00 PM ET at abstracts.asco.org. The American Society of Clinical Oncology (ASCO) Virtual Conference will be held from May 29-31, 2020.
In addition, the Company will publish online two e-abstracts featuring its Miliciclib compound for the treatment of hepatocellular carcinoma on 13 May 2020 but which will not be presented as part of the conference.
Poster Discussion Session, Breast Cancer, Metastatic:
|●||Abstract #1020: “Comparison of StemPrintER, a novel biology-based genomic predictor of distant recurrence in breast cancer, with Oncotype DX in the TransATAC cohort”|
Poster Session, Breast Cancer, Metastatic:
|●||Abstract #1057: “Integration of the stem cell biology-based genomic tool, StemPrintER, with clinicopathological parameters for the prediction of distant recurrence in ER+/HER2- breast cancer (BC) patients”|
|●||e16711: “Phase 2a safety and efficacy of Milciclib, a pan-cyclin dependent kinase inhibitor, in unresectable, sorafenib-refractory or -intolerant hepatocellular carcinoma patients”|
|●||e16634: “Safety and clinical activity of combination treatment with regorafenib and milciclib in liver transplant patients with hepatocellular carcinoma recurrence”|
“These data being presented at ASCO are significant for our oncology portfolio and highlight a complementary technology for detection of breast cancer,” said Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences. “Of particular note is that one of these studies was selected to be part of a poster discussion session during the meeting. We look forward to sharing these critical data on our StemPrintER clinical diagnostic for ER+/HER2- breast cancer patients and its utility in potentially optimizing therapeutic decision-making, especially in the discussion of StemPrintER relative to the current market leader, Oncotype DX.”
StemPrintER is a multi-gene prognostic assay intended for the prediction of the risk of recurrence in luminal, estrogen receptor-positive HER2-negative breast cancer patients, based on the detection of 20 cancer 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.
Milciclib is a potent, small molecule inhibitor of multiple cyclin-dependent kinases (CDKs), tropomycin receptor kinases and Src family kinases controlling cell growth and malignant progression of cancer. Milciclib has demonstrated safety in 316 patients with advanced solid cancers in Phase I and II studies and shown indications of efficacy. In two completed Phase II thymic cancer trials, Milciclib successfully increased overall survival and met both primary and secondary endpoints. While the current standard of care for hepatocellular carcinoma (HCC), the most common liver cancer, is only effective in a small percentage of patients, Milciclib has the potential to be broadly effective because it targets the underlying cause of disease. A unique feature of Milciclib is its ability to reduce microRNAs, miR-221 and miR-222, that promote the formation of blood vessels (angiogenesis) to facilitate the spread of cancer cells. Levels of these microRNAs are consistently increased in HCC patients and may contribute towards resistance to treatment with Sorafenib.
About Tiziana Life Sciences
Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, multiple sclerosis, type-1 diabetes (“T1D”), Crohn’s disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.
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Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry; its beliefs; and assumptions. 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. 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.
Tiziana Life Sciences plc
Gabriele Cerrone, Chairman and founder +44 (0)20 7495 2379
Cairn Financial Advisers LLP (Nominated adviser)
Liam Murray / Jo Turner + 44 (0)20 7213 0883
Shore Capital (Broker)
Antonio Bossi / Fiona Conroy +44 (0)20 7601 6125