RGS:ASX

Regeneus Ltd.

Regeneus Ltd. is a clinical-stage regenerative medicine company developing a patented portfolio of therapies to address significant unmet medical needs in the human and veterinary health markets. The company has four therapies targeting human conditions in various stages of development including two products approved for first-in-human Phase 1 trials: Progenza is an allogeneic off-the-shelf adipose stem cell therapy to treat osteoarthritis and other musculoskeletal conditions; RGSH4K is a human autologous personalized therapeutic cancer vaccine to treat a wide range of cancer types. Furthermore, Regeneus is developing therapies to target acne and other inflammatory skin conditions in humans, in addition to musculoskeletal and oncology treatments for animals.
RGS:ASX

Expert Comments:

Dennis Hulme, Edison Investment Research (4/24/17)
"Regeneus Ltd. is developing and commercializing its adipose-derived mesenchymal stem cell technology for musculoskeletal conditions in animals and humans. . .Regeneus entered into a US$16.5m collaboration with AGC Asahi Glass (AGC) for manufacture of Progenza for the Japanese market. . .recent Japanese legislation offers an accelerated path to market for regenerative medicine products. Regeneus also holds global rights to autologous cancer vaccine technologies for human (RGSH4K - Phase I began in Q215) and veterinary (Kvax) applications. . .Regeneus' strategy is to partner its product opportunities for development and commercialisation, allowing it to focus on early-stage product development."

Dennis Hulme, Edison Investment Research (3/23/17)
"Regeneus entered into a US$16.5m collaboration with AGC Asahi Glass (AGC) for manufacture of Progenza for the Japanese market. Regeneus and AGC have formed a 50:50 JV for clinical development and commercialisation of Progenza in Japan – we expect the JV to sub-license one or more partners to undertake clinical trials in a number of indications in Japan. . .Japanese legislation offers an accelerated path to market for regenerative medicine products. . . in addition to the AGC deal for Progenza in Japan, it has partnered with a top-5 global animal health company for development of CryoShot Canine."

Dennis Hulme, Edison Investment Research (2/16/17)
"Regeneus Ltd. and Asahi Glass have formed a 50/50 joint venture (JV) for clinical development and commercialization of Progenza in Japan. We expect the JV to sublicense one or more partners to undertake clinical trials in a number of indications in Japan. . .Regeneus will seek to identify wider applications of its off-the-shelf Progenza human stem cells beyond the initial development for osteoarthritis."

Regeneus, an Australian regenerative medicine company, has entered into a collaboration with a major Japanese firm to manufacture its stem cell therapy Progenza, a move that may accelerate approval and that has a pair of analysts optimistic about the company's future.
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"Recently, there was a deal between an Australian biotech called Regeneus Ltd. (RGS:ASX) and a very large Japanese corporate conglomerate called Asahi Glass (AGC). Now, the name doesn't really spell it out for you, but AGC is Japan's largest biologics CMO. AGC is basically saying it would like to expand its CMO offerings from a simple biologics manufacturing capacity to regenerative medicine. . . for a company of Asahi Glass' caliber to come out and say, "We're going to enter into the regenerative medicine space now," is highly indicative of the potential seen by the firm in the space. Also it highlights that when one looks to Japan, the usual suspects that are the pharmaceutical companies are not the only places to look; that's one thing that Regeneus was able to do. . .Regeneus licensed to AGC the right to manufacture Progenza for Japan; for that, AGC is paying US$5.5M up front and an additional US$11M in specified milestones, one or two of which will likely come within the 12 to 18 months. Another part of this deal that Regeneus and Asahi Glass signed was the formation of a subsidiary, 50% owned by each of the companies. This company will allow both involved companies to have a say in who the marketing partner for Progenza will be in Japan. . .This is a nicely designed deal. Regeneus gets the upfront payments and the milestone payments from AGC, but it also gets a portion of subsequent milestone payments and upfront payments from any pharmaceutical company that it teams up with for the commercialization rights." read more >

Dennis Hulme, Edison Investment Research (1/27/17)
"Regeneus Ltd. has entered into a US$16.5m collaboration with AGC Asahi Glass (AGC) for manufacture of Progenza for the Japanese market. Regeneus and AGC have formed a 50:50 JV for clinical development and commercialisation of Progenza in Japan. . .our valuation of Regeneus increases to A$120m or A$0.57/share, with the AGC cash and larger addressable market in Japan partly offset by longer timelines and revised assumptions for CryoShot and Kvax. . .The much-anticipated deal, which had taken 18 months to Regeneus brings cash, a manufacturing solution and a partner that can open doors in Japan."

Dennis Hulme, Edison Investment Research (12/8/16)
"Regeneus Ltd. is developing and commercializing its adipose-derived mesenchymal stem cell technology for musculoskeletal conditions in animals and humans. . .Recent Japanese legislation offers an accelerated path to market for regenerative medicine products and the company is currently working to finalise manufacturing and clinical development partnerships in Japan. Regeneus also holds global rights to autologous cancer vaccine technologies for human (RGSH4K - Phase I began in Q215) and veterinary (Kvax) applications. . .cancer immunotherapy, including cancer vaccines such as RGSH4K, is a biotech hotspot."

More Expert Comments

Experts Following This Company

Dennis Hulme, Analyst – Edison Investment Research
Maxim Jacobs – Edison Investment Research
Colin Lee Novick, Managing Director – CJ PARTNERS

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Investing Highlights
 
RGS entered into a strategic collaboration and licensing agreement with AGC Asahi Glass (AGC) for the exclusive manufacture of Progenza in Japan
 
Patented portfolio of personalized and off-the-shelf cell therapies for human and veterinary markets.
 
Veterinary products CryoShot Canine and Kvax are in advanced clinical stage and ready for partnering
 
Progenza and RGSH4K are in first-in-human clinical trials