NEW YORK – Clinical stage biotechnology company Tiziana Life Sciences said on Wednesday it plans to spin off its StemPrintER asset into a separate and independently listed public company called Accustem Sciences.
StemPrintER is a genomic signature-based assay for the prognosis of early and late recurrence of ER-positive, HER2-negative breast cancer in early-stage cancer patients. In 2019, Tiziana said it presented two posters at the American Society for Clinical Oncology's annual meeting that showed StemPrintER outperformed Exact Sciences' OncoType DX breast cancer prognostic recurrence assay in a 10-year risk prediction in more than 800 ER-positive, HER2-negative postmenopausal breast cancer patients. The company also said that its results from a study of more than 1,800 tissue samples from patients with ER-positive, HER2-negative breast cancer showed that the StemPrintER Risk Score (SPARE) model was approximately 20 percent superior to traditional clinicopathological parameters in providing prognostic information, and was 40 percent to 50 percent more accurate in lymph node-negative and 1 to 3 lymph node-positive patients.
Tiziana first announced plans in June for a possible demerger of its genomics-based personalized medicine business into a firm focused on breast cancer recurrence prediction. It will now hold a shareholders meeting on Oct. 2 to vote on the details of the plan.
As part of the demerger, Tiziana said it will provide the new entity with $1.3 million in cash. The firm will also distribute a 1-to-1 share dividend to its shareholders, effective Oct. 30. Accustem's shares will be listed on the London Stock Exchange late in the fourth quarter of 2020, and may potentially become listed on the Nasdaq in 2021.
Accustem will seek CE marking in November for StemPrintER, and the company anticipates being able to commercialize the assay in Europe in the second quarter of 2021. The company also intends to seek approval from the US Food and Drug Administration, Tiziana said.
"We believe that we have not received the proper valuation for the [StemPrintER] technology while it has been part of Tiziana," Tiziana Chaiman Gabriele Cerrone said in a statement. "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."