Member Info for olderbutwiser

I have some vague recollection that Nuformix had done some preliminary informal inhalation trials, or am i confused? Can anyone recall?
Or maybe it was not trials but general inhalation compound work.?

Anne seems very relaxed and positive. She has done well to get all the required studies up and running so quickly.
I have some vague recollection that Nuformix had done some preliminary informal inhalation trials, or am i confused? Can anyone recall?

"The FDA's proposal not to include tranilast in 503A Bulks List was contrary to the advice of the PCAC (Pharmacy Compounding Advisory Committee) who advised to keep it . They (PCAC) assert that FDA's view is based on a faulty understanding of the increased bilirubin observed in clinical trials and note that the proposed topical dosage is well below that used in those trials. "
With NXP002 release being so much better controlled, the dose required could be even smaller still and that it is given by inhalation to the lungs should also assist the FDA to reconsider Tranilast.

This is indeed great news.
As Soup says - another piece of the jigsaw that is eventually coming together for Nuformix.
The cancellations/ changes to the patent make no material difference as far as I can see - latest claims are a clearer and better way to word the claims - which is why they have done it.

ForFXSake
Similar sentiments- ! shall be staying put too - with the same hopes.
But I do get a distinct feeling that with the new BOD and Anne driving things that the BS has ended and real progress is being made and that she can and will close deals.
Although it does not reflect in the sp she has achieved a lot since coming on board and I believe the current research on NXP002 and NXP004 will help deliver deals and get this sp back up to where we investors are a lot happier.
ATB

Thanks Soup.
You are absolutely correct re NXP002.
My previous comment on cocrystals and clinical trials was solely related to NXP004 for oncology - a new cocrystal of NXP004 could potentially be brought to market with little clinical trials - subject to review by the FDA, etc.

A cocrystal version of an existing drug that is already on the market, does not necessarily have to go through clinical trials (full or otherwise). Depends whether it is considered a drug product intermediate by the FDA etc.
That can be one of the advantages of cocrystals, as well the IP benefits.

Soup
"Having a bit of trawl through the possibilities of what NXP004 might be working with.
To me, at the moment, there are two products that seem to fit the criteria we are aware of, these are Ibrance by Pfizer and Opdivo by Bristol Myers Squibb."
I did spend a bit of time a while back doing the same thing and was surprised how many £1B oncology drugs were listed - what I thought would be a shortlist ended up as a longlist.
Thanks for the cocrystal info - although it was 2007 still applicable.
Found this the other day - may be interesting to some https://fas.org/sgp/crs/misc/R46221.pdf

Possibly useful extracts from previous RNS's
"NXP004 represents novel forms of an undisclosed marketed oncology drug that has significant sales (more than £1 billion per annum in 2020) and is showing further growth. Nuformix filed one patent application on novel forms of this drug in 2020. Further outsourced research, through an expert contract organisation, on additional new forms and their properties has now commenced. If the research is positive, further patent applications may be filed."
"NXP004 uses Nuformix proprietary technology applied to the active drug of a multi-billion-dollar product currently marketed for oncology indications. Despite the commercial success of the marketed product, side-effects pose a significant challenge to its existing use and extension into new indications, that could also benefit from its mechanism of action. We are currently evaluating new IP that could overcome some of the challenges posed by the originator's formulation."
"The Company's instinct was to use cocrystal technology to overcome some of the formulation issues and open up potential new therapeutic applications for NXP004. "
So they are patent pending for some forms and further research may offer wider patent cover for NXP004 during next few weeks/ months.
So new cocrystal form which provides new IP and possibly better formulation / reduced side-effects.
They would be in position to initiate discussions (with NDA in place) once they submit second patent, or possibly even earlier, dependent upon what the first patent covers.
ATB TOODLEPIP

I think we may be talking at cross purposes.
I would rather work on what tangible statements there are from the company.
The following is taken from RNS 10th march:
"Should the further research be positive, there are two potential options for licensing the Company's IP to generate value from NXP004:
· license to the originator of the marketed drug to potentially extend its patent protection, thus potentially adding significant value for the originator; or
· license to generic companies to potentially allow commercialisation of a generic alternative to the marketed drug."

So Anne is directly writing that there are two competing routes for NXP004 licensing - that the originator will want to keep their £1Bn a year market share for another 20 years whereas the generic supplier will want to get into the market with that drug and could without waiting for IP expiry on the original drug.
My point is that both the originator and the generic supplier will be chasing Nuformix to close a deal quickly.
I am only talking about NXP004 here.
No one knows what happened with NXP002 negotiations other than the Nuformix BOD.
ATB

ForFXSake
Commercial discussions commonly involve knowledge that there are others interested and that therefore there is a need to move negotiations on quickly and commit to a deal.
Having more than one company interested and competing in buying a product is a very standard business situation - which obviously has to be handled with tact and care. It would be a very good situation for Nuformix to be in.
I feel sure Anne and the new BOD would be able to handle any competing negotiations for NXP004 between the originator and a generic manufacturer and drive such a situation to a good outcome. I was not thinking of a bidding war - .
Did they have a similar scenario with NXP002 - I am not aware that they did - from what little we know the asian discussions withered due to negotiations stalling possibly due to inadequate or poorly presented data from Nuformix at that time and possibly because there was no need for the asian company to move quickly ( I assume this based upon Anne's comments).
I cannot see it would be anything other than an extremely good situation to be in for Nuformix and for us investors.

I see real potential for negotiations and deal on NXP004 before a deal for NXP002 - because of the leverage that Nuformix could potentially have here.
Just my gut feel.

I see a lot benefits to NXP004 – Nuformix could be in the driving seat on this drug and set the pace of negotiations by approaching both the originator and potential generic manufacturers and see who bites first and with the best offer.
From earlier RNS
NXP004 (undisclosed drug) - Oncology
The Company has discovered novel forms of an undisclosed marketed oncology drug that has significant sales (more than £1 billion per annum in 2020) and is showing further growth. The Company has filed one patent application on these novel forms and is currently conducting further research on other new forms and their properties. Should the further research warrant it, the Company may file an additional patent application. In addition, the Company is evaluating the potential advantages of the new forms that have been discovered. If the patents on these new forms are granted there is potential for patent expiry to extend to 2040/2041. While there is literature data and preliminary preclinical data generated by the Company providing evidence for this drug's potential activity in fibrosis, it is the Company's strategy that in order to derive most value from the NXP004 asset, the opportunities in oncology should be exploited as a priority.
Should the further research be positive, there are two potential options for licensing the Company's IP to generate value from NXP004:
· license to the originator of the marketed drug to potentially extend its patent protection, thus potentially adding significant value for the originator; or
· license to generic companies to potentially allow commercialisation of a generic alternative to the marketed drug.

Good update.
Both research studies are outsourced.
Sounds like NXP002 research study has been under way for some time now and that NXP004 has just been started.
I am particularly intrigued by NXP004 - suggests that NXP004 is looking better than initially expected, since they seem to brought this research work forward compared to earlier RNS comments.
Oxilio negotiations on track.
Anne and the new BOD are doing the business.

Hi Soup
Just wondering about 60% churn comment.
The volume (shares traded) shown on share websites include both sells and buys - I have monitored it to check.
Churn involves moving shares to another person which involves a sell and a buy.
So by my reckoning it will probably be a 30% churn of shares.
Just my musings.

I believe Anne is doing the right thing - which is to put all resources , funding and effort into getting deals done for 001, 002 and 004, with most emphasis on 002.
Deals are needed to bring in cash flow and drive confidence. So all effort must be put into getting to a position where deals can be done. In the short term this requires a strict control of costs and directing effort to where it is most effective.
There is no point having an expensive scientist (about £140k per year cost ) working on yet more new research with new drugs which is not going to result in deals in the next year and will just result in existing funds being spread even wider and thinner. So Joanne 's amicable departure with future assistance being available is the optimum solution. Having two chemists is a luxury at this point.
Presumably once some deals are done then there may be the option for Joanne to return to pick up the research baton.
Anne is doing what should really have been done over a year ago.

ForFXSake
It is Anne Brindley who has the extensive expertise in inhaled therapies and also IPF - as she herself said in her first interview. Also read her CV.
Her experience is exactly what Nuformix requires.

"We are very pleased that Jo will continue to provide support as needed in these areas as the Nuformix portfolio moves forward in development. We sincerely wish Jo all the best in the future and look forward to our continued working together in a renewed capacity."
Joanne's leaving was obviously very amicable and she is still available - presumably to assist and guide Alex as required on remaining 001, 002 and 004 research.
" as the Nuformix portfolio moves forward in development" - suggests that Anne's plan is still proceeding
What we all need is for Anne to come out and say what is happening and reduce the uncertainty that has been generated.

Perhaps the situation is simpler than our imaginations let us believe.
Anne raised £1.5 million just a few weeks ago, and stated what those funds were to be used for and outlined a way forward with likely inflection points.
They need to do deals for the existing pipeline - currently there is no benefit in researching new cocrystals and adding them to the pipeline - so the need for Joanne becomes questionable.
Joanne is an expensive overhead and now without real research work to do - so her resignation seems logical for her to pursue other work and save the company unnecessary expense.
The proposed work phases would not really have needed much input from Joanne - so having her available to support when and if required is possibly the best option.
The new NED's, the new Chairman and the new PR outfit possibly suggests things are moving on as necessary.
But I agree it would be nice to have some update from Anne that things are on track and tickety-boo!

It is who owns those patents that is central and it will be Nuformix who own them - and there will be extensive background information within the company detailing any supporting data leading up to those patents. Important research data is not just held in peoples heads, it is carefully reported and recorded within the company.
While I was not expecting this, there is the old adage that 'no one is indispensible' - but I am pretty sure it will not affect potential future partners dealing with the company.
The company will need to change the assigned name for the patent - but that is fairly straightforward to do, as I have had to do that for companies I worked for and held patents in my name for.