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Tiziana Life Sciences #TILS – Demerger of StemPrintER Genomics-Based Personalized Medicine business as a separate listed company

New York and London, May 22, 2020 – Tiziana Life Sciences plc (NASDAQ: TLSA, AIM: TILS), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, today announces that it intends to demerge its StemPrintER and SPARE (together “StemPrintER”) genomics-based personalized medicine businesses into a separate company and effect a capital reductionto facilitate the spin-out and listing of StemPrintER as an independent entity.

Following the Company’s recent announcement concerning the trial conducted by scientists from the European Institute of Oncology in Milan in collaboration with the Royal Marsden Hospital and Queen Mary University in London on the Company’s stem cell biology-based genomic tool, StemPrintER, for the prediction of disease recurrence in breast cancer patients, the Company’s Board, which has been considering options for StemPrintER for some time, is pleased to announce that they consider that the results of the trial and the progress made substantiate the viability of StemPrintER as having the potential to be a standalone business and accordingly intend to proceed with steps for a spin-out, by way of demerger, and listing on a public market of a new independent genomics-based personalized medicine company focused on the StemPrintER business.

The rationale of this decision is that, as a standalone genomics-based personalized medicine company and separate legal entity, StemPrintER could:

  • Secure separate financial resources, with the goal of enabling accelerated development of the StemPrintER genomic test;
  • Separate StemPrintER from Tiziana’s biotechnology and pharmaceutical businesses so it may focus on the personalized medicine market; and
  • Allow Shareholders to benefit from both Tiziana’s rapidly developing drug portfolio and the standalone value of StemPrintER as it progresses through its own development milestones and the path to commercialization and allow shareholders to receive the maximum potential value from StemPrintER as a standalone entity.

The Board is taking the necessary preliminary steps in preparation for a potential spin-out, including the incorporation of a new subsidiary to hold the relevant assets. The Company will also put proposals to shareholders at the Annual General Meeting to obtain the approval necessary for a capital reduction which will be required to implement the demerger.

Notwithstanding that the required approval for the capital reduction will be sought, these considerations remain at an early stage and there can be no guarantee that the demerger will be completed. The approval of the capital reduction will enable the Board, in due course, to declare distribution in specie of shares in the new StemPrintER entity to existing Tiziana shareholders.

No record date has yet been set for the entitlement to shares in the new StemPrintER entity as a number of technical, legal and accounting processes need to be completed before the demerger can be formally put to shareholders of Tiziana for approval. For the avoidance of doubt StemPrintER will remain a group business until such time as shareholders formally approve proposals for a demerger.

For shareholder interest and information, StemPrintER will be the subject of a poster discussion session (https://meetinglibrary.asco.org/record/185144/abstract) on 29 May 2020 titled “Comparison of StemPrintER, a novel stem cell biology-based genomic predictor of distant recurrence in breast cancer, with Oncotype DX in the TransATAC cohort” at the virtual annual meeting of American Society of Clinical Oncology 2020 (ASCO20).

Further announcements will be made at the appropriate time.

About StemPrintER and SPARE

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.

For more information go to http://www.tizianalifesciences.com

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

THE PERSON WHO ARRANGED FOR THE RELEASE OF THIS INFORMATION IS DR KUNWAR SHAILUBHAI, THE COMPANY’S CHIEF EXECUTIVE AND CHIEF SCIENTIFIC OFFICER.

Contacts:

Tiziana Life Sciences plc

United Kingdom:

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

United States:

Investors –

CORE IR

(516) 222-2560

ir@coreir.com

Media
Jules Abraham

CORE IR

(917) 885-7378

julesa@coreir.com

Tiziana Life Sciences #TILS – ASCO Conference – StemPrintER Study Presentation

Tiziana Life Sciences Announces Data Demonstrating StemPrintER’s Superiority Compared to OncotypeDX in Providing Prognostic Information to Conventional Clinical Parameters in Breast Cancer Patients in Poster Discussion Session at the American Society of Clinical Oncology (ASCO) Virtual Conference 

Additional data to be presented validating the SPARE Model for Distant Metastasis Prediction utilizing the Company’s StemPrintER Platform

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

 

New York/London – May 14, 2020 – Tiziana Life Sciences plc (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces today that a new study will be presented by scientists from the European Institute of Oncology in Milan in collaboration with the Royal Marsden Hospital and Queen Mary University in London on the Company’s stem cell biology-based genomic tool, StemPrintER, for the prediction of disease recurrence in breast cancer patients during a poster discussion session at the American Society of Clinical Oncology (ASCO) Virtual Conference. The study demonstrates greater refinement and superiority of StemPrintER over current market leader Oncotype DX in delivering prognostic information as part of the therapeutic decision-making process in ER+/HER2- breast cancer patients. An additional abstract from the scientists at the European Institute of Oncology will be presented in a separate poster session, which details a further refined risk model, the SPARE model, based on the combination of StemPrintER with clinical parameters for distant metastasis prediction. Both abstracts, became available May 13, 2020, while the posters and discussion session will be held during The American Society of Clinical Oncology (ASCO) Virtual Conference May 29-31, 2020.

Each of these studies independently provides significant additional information on the value of StemPrintER — and its derivative SPARE (detailed below) — as clinical tools to aid personalized therapeutic decision-making in women with ER+/HER2- breast cancer. Of particular note is the comparative precision of StemPrintER over Oncotype DX in predicting the potential recurrence of certain types of breast cancer following treatment. The two studies highlight the importance of the stem cell approach to develop a potentially powerful prognostic tool to predict breast cancer prognosis.

Abstract #1020, “Comparison of StemPrintER, a novel biology-based genomic predictor of distant recurrence in breast cancer, with Oncotype DX in the TransATAC cohort,” is an independent validation of the prognostic value of StemPrintER in a cohort of more than 800 luminal ER+/HER2- postmenopausal breast cancer patients from the international TransATAC study and a head-to-head comparison of the prognostic power of StemPrintER with OncotypeDx. Results provide independent validation of StemPrintER as a potentially powerful prognostic tool to stratify patients for the risk of early or late recurrence independently of other clinicopathological parameters. Importantly, the study also shows that StemPrintER is superior to OncotypeDX in the prediction of 10-year recurrence risk in all patients, as well as in N0 and N1-3 patients. The study further demonstrates that StemPrintER is capable of outperforming OncotypeDX in providing additional prognostic information to the standard clinicopathological parameters.

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,” develops a more refined risk model for distant metastasis prediction, which combines StemPrintER with tumor size (pT) and nodal status (pN). The new model is termed SPARE (StemPrintER for Personalized Adjuvant Therapy in Endocrine Receptor-Expressing Patients) and, in the analysis of a consecutive-retrospective cohort of more that 1,800 ER+/HER2- breast cancer patients with 15-year complete follow-up from the European Institute of Oncology (IEO) in Milan, revealed to be an even more powerful tool, compared to the original StemPrintER for predicting early and late distant metastasis risk independently of standard clinical parameters.

“These data sets demonstrate that StemPrintER has the potential to become an essential prognostic tool that will help clinicians to tailor more or less aggressive therapy based on a more accurate risk assessment of disease recurrence compared to what we have seen to date,” added Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences. “This product also represents an important addition to our existing therapeutic pipeline as it opens Tiziana into the area of precision medicine, creating an entirely new business line beyond our current patented technology in offering new delivery mechanisms for monoclonal antibodies.”

About StemPrintER

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.

The person who arranged for the release of this information is Dr Kunwar Shailubhai, the Company’s Chief Executive Officer and Chief Scientific Officer.

About Tiziana Life Sciences

Tiziana Life Sciences plc is a dual listed (NASDAQ: TLSA & UK AIMS: TILS) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn’s Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn’s Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

 

Receive news and updates from Tiziana Life Sciences plc by signing up to get email alerts at https://ir.tizianalifesciences.com.

 

Forward-Looking Statements

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.

  

Contacts:

Tiziana Life Sciences plc

United Kingdom:

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

 

United States:

Investors

CORE IR

ir@coreir.com

 

Media

Jules Abraham

CORE IR

(917) 885-7378

julesa@coreir.com

Tiziana Life Sciences #TILS to present two studies featuring StemPrintER during the American Society of Clinical Oncology (ASCO) Virtual Conference

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. 

Abstracts include:

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”

e-Abstracts include:

·      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.”

About StemPrintER

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. 

About Milciclib

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.

Receive news and updates from Tiziana Life Sciences plc by signing up to get email alerts at https://ir.tizianalifesciences.com.

 

Forward-Looking Statements

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.

Contacts:

Tiziana Life Sciences plc

United Kingdom:

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

 

United States:

Investors

CORE IR

ir@coreir.com

 

Media

Jules Abraham

CORE IR

(917) 885-7378

julesa@coreir.com

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