Regeneus Ltd (ASX: RGS) (Regeneus or the Company), a clinical-stage regenerative medicine company, announced today that the Japanese Patent Office has decided to grant the Company a new key patent, covering the use of its lead stem cell technology Progenza™ to treat pain, through to 2032.
DISC: I don't hold but do hold OCC
Regeneus company focuses on improving pain management of patients, the company does this by using regenerative medicine (stem cells). This is achieved by interrupting the inflammatory cascade that leads to pain.
Total Addressable Market (TAM)
- Pain, 1.5 billion people suffer from pain and 50% report inadequate pain relief
- Osteoarthritis, 240M sufferers globally, expected to be a ~US$4bn market by 2026.
Their R&D partners include Monash Uni, Uni of Adelaide, UNSW, University of Tech Sydney and Agency for Science, Technology and Research (A*STAR) in Singapore.
Cellular therapy that targets pain/inflammation through the use of Secretome, this improves both resident tissue and Mesenchymal Signalling Cells (MSCs) aka the stem cells.
Progenza’s mechanism of actions turns inflammatory immune cells into anti-inflammatory cells, thereby addressing inflammation at its source. In turn this downregulates pain-causing signals and repairs damaged tissues, such as cartilage tissue, commonly found in joints such as knees and elbows
- Progenza completed Phase 1 of trials for knee osteoarthritis and showed that a single injection into the knee was safe and tolerable. Progenza showed significant, rapid and sustained reductions in knee pain for OA patients. The treatment showed positive signs of disease modification, showing no deterioration in the joint following the injection.
- Progenza OA phase 2 trials will be progressed soon as per 4C (30/10/20)
- Progenza got positive pre-clinical trial results in treating neuropathic pain, company looking to advance to phase 1 trial as per 4C (30/10/20)
- The company is aiming to have Progenza commercialised and on shelves in Japan for OA by 2023-2024.
Kyocera Progenza Deal
- Company recently signed a collaboration and licencing agreement with Kyocera, a Japanese company with a $21bn Market Cap. (13/8/20)
- The Progenza deal includes around $27M in upfront and milestone payments, with future royalties on future Progenza sales
- Japan with it’s ageing population has an estimated osteoarthritis patient population of around 26 million and the numbers are sharply increasing every year.
- This deal is exclusively for development and commercialisation of Progenza for knee osteoarthritis in Japan. Kyocera will fund manufacturing, development and commercialisation costs
- Sygenus is a cell-free topical (Topical meaning that it can be applied to a particular place on the body, an example can be creams that are applied to the skin) serum and gel treatment for pain and inflammation derived from Adipose MSCs. Sygenus reduces pain and inflammation, while accelerating tissue healing and repair. Its safety and tolerability have been confirmed in human pilot studies.
- The activity of Secretome gives Sygenus a significant advantage as a topical application to not only provide long lasting relief from the sensation of pain but modifying the cause of the pain.
- In 2017 Sygenus showed to be more potent and had a longer lasting effect on pain than morphine in a preclinical study.
- As per 4C(30/10/20) There should be a new patent to be granted in the US, expanding the tech into Aesthetics Therapeutic market. This patent covers a wide range of non-inflammatory skin conditions with adipose-derived cell secretions. (Age spots, wrinkles, and other age-related conditions through to 2032)
- Around $1.7M revenue FY2020
- Market Capitalisation of $38M @ 12.5 cents
- 277,824,988 million shares on issue
- With recent payment from Kyocera of $5.6M, the loan facilities have been cancelled meaning comp is Debt free. 4C(30/10/20)