Regeneus begins to etch pathway to drug commercialisation, exuding confidence in their tech

Modern medicine is akin to magic, a notion exemplified when looking at the regenerative power of stem cells. 

Whilst we’ve barely scraped the surface of what these powerful cells can do, regenerative medicine holds promise as a “magic fix” for many an ailment. 

Clinical stage regenerative medicine company Regeneus (ASX: RGS) is working to develop innovative stem cell based treatments for a variety of conditions including osteoarthritis, neuropathic pain, and skin conditions. Their lead assets are novel cell-based therapeutics Progenza™ and Sygenus- “novel approaches to pain that leverage stem cells as cellular pharmacies and utilise Secretome as a therapeutic agent.”

Confused? Allow me to break it down. 

Progenza™ is designed to treat pain and inflammation, namely in osteoarthritis where there are no current pharmacologic treatments. The therapy is designed as an alternative to more invasive interventions like surgery, and unlike analgesia often prescribed to manage osteoarthritis pain, Progenza™ meaningfully addresses the condition. Once injected, stem cells quell inflammation at the source by repairing damaged tissues and downregulating pain signals. The drug yielded positive Phase 1 trial results and is currently in Phase 2 trials. Additionally, the drug is being explored preclinically for neuropathic pain. 

Sygenus is a topical product that also reduces pain and inflammation whilst repairing tissues. Unlike Progenza™, Sygenus doesn’t include stem cells but rather, selective bioactive molecules. The cream promises to provide long lasting pain relief. Preclinical work is currently being carried out on the cream, with Phase 1 trials to commence once the Company has secured a suitable partnership. 

Regeneus is obviously keen to get the ball rolling when it comes to commercialising Progenza™. A global search has been initiated to secure additional partners for the drug’s commercialisation with over 30 South Korean companies contacted already. Over in China, Regeneus has appointed YAFO Capital to oversee the licensing process for the drug. YAFO has successfully seen multiple drugs through this process including Biosplice’s lorecivivint and Flexion’s Zilretta, both drugs indicated for use in osteoarthritis. 

In Japan, the Company saw partners, Kyocera Corporation continue discussions with regulators regarding relevant data to begin mapping out their path to commercialisation in the country. 

During the quarter, Regeneus has also applied attention to Progenza™’s other possible indications which include meniscus repair. A proof-of-concept study conducted in collaboration with the Kolling Institute delivered positive results on this front, proving the drug’s efficacy on the structural repair and pathology of the knee joint, further supporting it to become the first Disease-Modifying Osteoarthritis Drug (DMOAD). 

Finance wise, the Company claims to be on solid ground with $95k in the bank, and an untouched credit facility of $3 million.