NovelStem Increases NewStem Ownership to 33% as NewStem Prepares for First-Half 2021 FDA Filing for Approval of its Stem-Cell Based Anti-Cancer Drug Resistance Diagnostic; NovelStem Initiates Process to Become Publicly-Reporting with S.E.C. and to Up-Lis

BOCA RATON, Fla. and JERUSALEM, Dec. 01, 2020 (GLOBE NEWSWIRE) -- NovelStem International Corp. (OTC Pink: NSTM), a biotechnology company focused on its stem cell-based technology platform, developed by Israel-based affiliate, NewStem, Ltd., announced today:

• NovelStem has completed the final $1M tranche of its NewStem investment, increasing its ownership to 33%, following NewStem’s successful, on-time completion of all development milestones set in July 2018.
• NovelStem has commenced a process to become an SEC reporting company and to up-list its shares in order to enhance the Company’s visibility and trading liquidity.
• NovelStem has a $3.6M market cap based on approximately 49M shares outstanding and a recent closing price of $0.0725. NovelStem has no debt and enough cash for the next 12 months of operations based on the current run rate of expenses.
• Development affiliate NewStem expects to file for FDA approval for its first diagnostic product in the first half of 2021 and targets the commercial launch of its first diagnostic product in second half 2021.
• NewStem has approximately $1.7M in cash which is expected to support it through the commercialization of its first product. NewStem wishes to secure one or more strategic partners to support commercialization of its diagnostic solution.
  

NewStem has developed a novel stem-cell-based technology platform used in the development of diagnostics and therapeutics. Using this technology, NewStem has identified and completed the analysis of resistance to the most frequently prescribed standard-of-care cancer treatments. NewStem is a spinoff of Yissum, The Hebrew University of Jerusalem’s technology-transfer company. NewStem holds intellectual property rights related to stem cells, including genome-wide screening methodologies. Its main patents were filed and allowed in both the United States (September 2020) and the European Union (June 2020).

In the first half of 2021 NewStem expects to file for approval for its first diagnostic product with the U.S. Food and Drug Administration's Center for Devices and Radiological Health. Given the anticipated review and approval timeline, NewStem is well positioned to potentially launch its first commercial diagnostic product in the second half of 2021.

NewStem’s diagnostic solutions are based on the research of specialized stem cells that carry just one set of chromosomes (haploid cells) by Professor Nissim Benvenisty, Director of the Azrieli Center for Stem Cells and Genetic Research at the Hebrew University. These unique cells “provide novel means for studying human functional genomics” (Nature, 2016), and their genetic manipulation “constructed an atlas of essential and growth-restricting genes in human pluripotent stem cells” (Nature Cell Biology, 2018). NewStem’s most advanced solution is a diagnostic product and database that enables NewStem to predict patients’ resistance to certain anti-cancer therapies, allowing for better, targeted personal-oncology treatments with the potential to reduce incidents of anti-cancer drug resistance which occurs in nearly 50% of all cancer cases. NewStem technology has the potential to significantly reduce ineffective treatments, thereby improving patient outcome while also potentially providing hundreds of millions of dollars in savings from unnecessary treatment costs.