Ann: CLINUVEL Newsletter, page-2

Fairly typical no news letter from Wolgren. Sowing the seed for a prolonged FDA appraisal, mentioning 24 months as a possible timeline for the first time. No mention of stalled EU rollout or UK appeal which is happening next week. No hint at last quarter sales despite it being due next week and high expectations built into the share price.

Wolgren for the first time highlighted the brilliance of Epitan (Clinuvel before Wolgren) to formulate the slow release delivery as a mechanism to reduce abuse. Perhaps highlighting this point of difference to the FDA (who I am sure read Clinuvel newsletters) from Palatin’s injection, bremelanotide. The NDA for bremelanotide as been submitted to the FDA in the form of a single dose injection. Bremelanotide will give a tan, appetite suppression and sexual arousal, clearly no chance for abuse of that injection. The irony is approval will probably be granted before Scenesse.

Another lie about releasing Singapore vitiligo results. The trial on 9 ( or thereabouts) patients finished years ago and results are essentially meaningless in such a small sample size. Wolgren prepared us for never seeing these results by saying that any vitiligo progress depends on successful FDA outcome for EPP. This to me doesn’t make any sense as the issue Clinuvel had with EMA/NICE etc is efficacy not safety. If Scenesse fails in US it will be because Wolgren has been unable to convince the FDA that the drug works for EPP, proving it works or otherwise for vitiligo will be a lot easier as success can be visualised and easily measured. Anyway they have stuck with this line of “reasoning” for the last while.

Perhaps the most disappointing aspect of the waffle was the further delay in the “new line”. We were told in March to expect an announcement in June, that was delayed to July and now we are told we may be drip fed information after regulatory and legal clearance is achieved. Pretty ordinary behaviour to promise something in March, months before regulatory clearance is achieved. Investors still have no idea what to expect in this space. Clearly Blijdorp does and he just dropped 13.5 million of his own personal billion into Clinuvel. So maybe it is good or maybe he just wanted a tax offset.

No mention of why Clinuvel’s two largest shareholders are selling down. All very good to shout about them buying and becoming substantial shareholders but when FIL and Lagoda are selling down consistently putting obvious downward pressure on the share price, all quiet on the Clinuvel front. I expect it is just a chance for them to cement a very healthy gain over a reasonably short time.

Also no mention of cutaneous porphyria trial due to start mid ’18. No mention of pilot study for second orphan indication in a new domain also due to start mid ’18.

All in all another typical newsletter from Wolgren with a lot of words not saying very much. Here’s hoping for a cracking quarterly and good news from the UK to get the share price moving again.