ORGENESIS INC., (ORGS) 05/25
A gene therapy biotech company with multiple red flags to watch out for
We have selected to cover ORGS due to a recent press release touting revenue increases. We decide to mainly
ORGS (Orgenesis Inc.)
52-week chart
Business Description - ORGS is a clinical and commercial-stage biotech company focusing on advanced (personalized) cell and gene therapies. The prime focus is the Point of Care (POC) platform specialized for automated and mechanized processing of patients’ own cells to undergo autologous therapies.
Next catalyst date - unknown
Key drug/asset: ORGS has been developing and commercializing the Point of Care (POC) platform as personalized cell and gene therapies for various medical conditions.
Why do we believe it is Tier 3?
Acquired from Kecellitics Biotech, the cancer treatment pipeline ORGCAR19 clinical trial is underway in China and Israel and the status of the development is unknown. Not just the phases or the status of the clinical trials unknown, the underlying science appears to be sketchy. Another product, Kyslecel, acquired from Koligo Therapeutics, is minimally manipulated and not-so-tightly regulated by the USFDA. Kyslecel is essentially the patient’s own cells that are processed in the laboratory before being injected back into the patient’s body to treat chronic pancreatitis. The product is being commercialized without being reliably tested for the presence of harmful microorganisms and the surgical procedure carries significant risks1.
Initially, touted as a potent anti-cancer therapy, Ranpirnase (Onconase®) is another pipeline that was reported to be successful in early-stage experimental/laboratory animal studies. The development of Ranpirnase in human clinical trials as an anti-cancer treatment has been discontinued for unknown reasons. One independent study2 reported significant side effects of Ranpirnase on semen production mechanisms, which could impede the patient’s willingness to undergo or continue Ranpirnase treatment. This could be the possible reason for the discontinuation or no further development of Ranpirnase for various clinical trial indications.
Although these side effects were observed in experimental animal studies, they could likely show up in human clinical trials as well, which could stop further development of the asset. Ranpirnase has been in clinical trials for over two decades and almost all the clinical trials indications failed badly, were withdrawn, discontinued, or ended up with no further development even after years3 of early-phase clinical trial completion4 (Phase 1/2 clinical trials for genital warts5)
The same Ranpirnase is being investigated under a different name OKG-301 (licensed by Okogen from ORGS) as a treatment for viral conjunctivitis in a phase 2 study. The phase III results might not be a good surprise for ORGS longs!