Hi folks
Well done Beale on getting the 4C forecast broadly correct and I agree with others on here about the uselessness of the projected number of quarters that can be funded from existing cash balances.
Anyway, as I mentioned in my post a week or so ago one of the reasons I am back in SUDA is due to Anagralide. There is alot of water that still needs to flow under the bridge of course but but if they can navigate their way through this product development it will make the company alot of money.
But that is a long way off and a lot needs to go right...
But they are taking steps forward. The AGM presentation provides a clear path that needs to be followed before the Phase 1 trial. See below:
So where are we at now? Its a good question... The below is from the Annual Report that came out in September.
Project Status
Anagrelide is a challenging drug to formulate. It is virtually insoluble in all major pharmaceutically acceptable solvents with a water
solubility of just 0.002mg/mL, which is over 1000 times less than needed for an oro-mucosal spray that requires a concentration of
~2.5mg/mL. It is insoluble in most non-aqueous solvents as well. SUDA’s technical team has been able to improve the solubility
by greater than 10,000-fold using novel solvent compositions and solubility enhancers. We are still working on developing a
formulation with the solubility and stability characteristics required for a pharmaceutical product. The technical team is confident
they can achieve this and are currently testing a number of formulations that have shown promise.
Assessment and optimisation of the permeability of the product in vitro has begun using artificial membrane models. Preliminary
flux rate estimates are very encouraging showing a high permeability for the drug. This is an ongoing process that will continue
throughout the formulation development and optimisation stage of product development.
Once a suitable oro-mucosal formulation has been developed, pre-clinical testing will be conducted to confirm the ability of an
oral spray formulation to reduce the formation of the cardio-toxic metabolite. This will pave the way for demonstrating proof-of concept (POC) in man
So my reading of that is that 4 months ago they were still in the formulation part of the development path. Once they have this sorted the next step is to undertake the pre-clinical testing.
They could very well have completed or be very close to completing the formulation. This would also then enable them to formalise the IP and apply for patent extension before coming out to the market with specifics of what they have done.
Anyway, why am I mentioning this now? Well I think it will be in the context of the next capital raising.
Given the negative sentiment on here if they just announced a capital raising for working capital than it is likely to be very poorly supported.
But on the other hand if the company makes an announcement stating that they have completed formulation work on a new Anagralide product with the solubility and permeability to warrant pre-clinical testing ahead of a first human trial then I think that not only would any CR be very well supported but also it would result in a significant increase in the share price.
All of this is predicated on the company and the lab having developed a suitable formulation of course and I have no idea if they are there yet.
But if I was the company that is what I would do.. align the need to raise money with the funding for the next stage of one its key internally developed projects.
(20min delay)