Ann: Investor Presentation, page-248

Also worth a read regarding the recent unfounded claims of IPSC MSCs vs sub-par Bone-marrow derived MSCs.

All cells, including stem cells/iPSCs, have the potential to mutate.

Most cancer cases arise due to mutations in a person's own cells.

Mutations causing cancer is a theoretical risk for all cell-based therapies.

CAR T cells may have a possible risk of secondary T cell malignancies, but they are not derived from iPSCs.

The risk of cancer due to iPSCs arises from their ability to self-renew and differentiate, similar to other cells.

Most mutations are harmless and do not necessarily have consequences.

Mutation risk is influenced by cell type and processing methods.

The iPSC reprogramming method used avoids "insertional mutagenesis" and other risk factors like advanced cellular age.

MSCs don’t persist long after administration, reducing their cancer risk.

Some cell-based therapies that engraft and remain in the body have a higher cancer risk.

Each batch of cells is screened for genetic abnormalities and tumorigenicity.

iPSCs are genomically stable during in vitro expansion, as shown in a 2020 Nat Med paper.:

“Comparative genomic hybridization (CGH) and single-nucleotide polymorphism (SNP) analysis showed there were no differences in iPSC samples taken before and after expansion through ten passages, indicating that iPSCs are genomically stable during in vitro expansion. The results from the iPSC samples were also compared to an Agilent Reference genome, and there were no mutations of known or potential clinical significance.”