Benzinga | Sep 16, 2020 06:01AM EDT

Tiziana Life Sciences Announces Planned Spin Out of StemPrintER into a New Publicly Listed Company, Accustem Sciences

NEW YORK and LONDON, Sept. 16, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, and focused on innovative therapeutics for oncology, inflammation and infectious disease, today announced plans for demerging its StemPrintER asset into a separate and independently listed public company, Accustem Sciences Limited.



StemPrintER is a best-in-class genomic signature-based assay for the prognosis of early and late recurrence of ER+/HER2 breast cancer in early stage breast cancer patients. In a side-by-side comparison study, StemPrintER was 40% more accurate than the Oncotype DX assay. In 2019, Tiziana presented two posters at the American Society for Clinical Oncology (ASCO) that showed StemPrintER outperformed OncoType DX in a 10-year risk prediction in more than 800 ER+/HER2 postmenopausal breast cancer patients. Results demonstrated that the next-generation StemPrintER Risk Score (SPARE) model is approximately 20% superior to the traditional clinicopathological parameters in providing prognostic information in more than 1,800 tissue samples from patients with ER+/HER2- breast cancer and is 40-50% more accurate in lymph node-negative (N0) and 1 to 3 lymph node-positive (N1-3) patients. Notably, Exact Sciences purchased the Oncotype DX assay from Genomic Health for $2.8 billion.

The Company will hold a shareholders meeting on October 2, 2020 to vote on the planned demerger. As part of the demerger, Tiziana will provide the new entity with $1.3M in cash.

Accustem Sciences intends to list on the London Stock Exchange (LSE) in late Q4 2020, and potentially a dual listing on NASDAQ in 2021. To effect the demerger, Tiziana plans to distribute a 1:1 share dividend to its shareholders with a record date of 0700 London time on October 30, 2020.

Accustem Sciences will begin the process of seeking CE Mark approval in November of 2020 with anticipated commercialization in Europe in the second quarter of 2021. Subsequently, the Company also intends to seek FDA approval.

Gabriele Cerrone, Chairman of Tiziana, commented: "We are extremely pleased to announce the planned spin out of our StemPrintER technology. We believe that we have not received the proper valuation for the technology while it has been part of Tiziana. Thus, we are now fulfilling our promise to shareholders to demerge the asset and create a new public company that will focus exclusively on the commercialization of StemPrintER. Our research indicates we have a far more accurate assay than our competitors, which gives us great confidence as we begin the final steps in monetizing this important technology.

For more details about the planned demerger and spin out, please see the Company's Form 6-K filed with the U.S. Securities and Exchange Commission on September 16 2020 and the Company's website http://www.tizianalifesciences.com/about-us/