Potentially two partnering deals in H215 Regeneus has sharpened its focus on its area of expertise in early-stage development of regenerative medicine products and cancer vaccines. This strategy appears to be bearing fruit, with partnering arrangements for both its human and veterinary off-the-shelf stem cell therapies expected to be finalised before the end of CY15. A partnering deal for Progenza in Japan is likely to be a re-rating catalyst. Our valuation is A$106m (A$0.51/share)… Two partnering deals expectedbefore year end The FY15 annual report indicated that it expects to finalise partnering discussions for both its human (Progenza) and veterinary (CryoShot) off-the-shelf stem cell products in the current half-year.Most significantly, it expects to finalise one or more deals with potential manufacturing, clinical and marketing partners for Progenza in Japan. Potential for two deals this calendar year Progenza The company is in discussions to establish a joint venture or other partnering arrangement to conduct a Phase II trial in osteoarthritis patients in Japan. Regeneus has encountered genuine interest from a number of potential partners, and anticipates finalising these discussions in H215.
Progenza is the key long-term value driver, with peak sales estimated at A$1.75bn. Therefore, clinical and regulatory progress over the next few years would significantly de-risk the product, which currently has a 15% probability of success. Cryoshot The company is looking to finalise arrangements in H215 with a marketing partner who would also support the final stages of development of canine CryoShot, including GMP manufacture and a pivotal clinical trial in dogs with osteoarthritis. (Deal 1?) Nov 2 2015: Unnamed “world’s top 5 animal health companies”; Upon completion of the study…anticipated Q3 2016…the unnamed animal health partner has “a period” in which to exercise it’s option to enter into an exclusive license over CryoShot technology. rgs to receive up front license fee and be entitled to other development milestones to be agreed at the time.
...earliest potential revenue "some period" after Q3 2016...when coy runs out of cash at current burn w/o additional revenue or cap raise. Annc. followed by 12% SP drop.
We estimate the company needs additional funds of A$2m for working capital in FY16 and A$4m in FY17. These funds could come from pending partnering deals, or potentially a capital raise.
Nov 2 2015 Cryoshot partnership: SP 13.5c
Nov 5 2015 (AGM): SP 12.0c
Nov 16 2015 Patent for allogenic stem cell technology platform: SP 11.5c
Nov 26 2015 Canine cancer vaccine commenced at SASH: SP 11.0c
Dec 7 2015 Presentation to AusTrade mission: SP 10.5c
Dec 14 2015 SP 10.0c
Dec 15 2015 Patent granted for cancer vaccine: SP 9.5c
Dec 16 2015 SP 9.6c
positive announcements absent revenue & declining SP.....certainly "no love for this turd".
Potential...expected...anticipated..discussions...anticipated finalising these discussions..?...but at least rgs are communicating now! Finalised discussions do not raise this coy revenue, mkt interest or lift SP. Signed contracts/agreements....
"We have assumed timely clinical and commercial progress in multiple regions, which should be achievable, but any delays/setbacks would have a negative impact on our valuation."
AusTrade mission present suggests delay in one or more Japan Progenza deals by year end. rgs informed & bought Edison report & built critical revenue & partnership performance expectations. Missing targets now after report discredited as wild optimistic "turd" a bad look.
Until rgs demonstrates commercial interest in its products/technologies & willingness for partners to put serious money on the table (& much needed revenue), SP will remain flat near low IMHO. Need to prove buyers for what rgs selling. If Japan Progenza partnering deals limited to canine Cryoshot trial type support-with option for future potential rgs revenue-look for cap raise & further ST SP/value erosion. AusTrade presentation mentions preference for non-dilutive revenue-sure SHers agree.
If rgs finalise Progenza contracts/agreements w/ serious up front partner cash before year end mkt might pay attention & lift SP. Time to see if outcomes of their working hard meets mkt expectations they've built.
RGS Price at posting:
9.6¢ Sentiment: Hold Disclosure: Held