Member Info for olderbutwiser

Hi FFS
Inhalation / nebuliser delivery is definitely the delivery method for NXP002 - it is a fundamental aspect.
I believe that Dan meant that they are redirecting what would have been an animal study using actual inhaled drug to investigate durability and instead are now planning to use a 3D model to investigate (virtually) certain aspects including durability.

Tue, 2nd Mar 2021 07:00
RNS Number : 7841Q
Nuformix Study results:
The preliminary data from this study shows that the combination of NXP002 with SOC provided strong evidence of additional effects compared to either SOC alone on both fibrotic and inflammatory markers. In addition, the results showed evidence of similar or better activity of lower doses of SOC in combination with NXP002, compared to higher doses of SOC alone, indicating a potential for a dose-sparing effect of the combination. These data supplement the previously reported study of NXP002 in the same preclinical model where positive effects were seen when NXP002 was dosed alone and now there is strong data in combination with SOC therapy.
Dr Lee Borthwick, Senior Lecturer in Fibrosis Biology at the Newcastle Fibrosis Research Group, Newcastle University, said: "The data from this most recent study of Nuformix's drug candidate, NXP002, are very encouraging in combination with current IPF drugs and show clear attenuation of both fibrosis and inflammatory markers in combination with pirfenidone or nintedanib. This reinforces previous work done in our laboratories on this compound."

Dan's words from interview:
"Recent research studies are still valid and of value having demonstrated good correlation of NP002 (Tranilast) with treatment efficacy - the timing of ERS was fortuitous – and now we just divert the intended costs and research studies into a 3D model of combination studies with NXP002. No change in R&D costs either."

Oddly the delays in 2020/ 21 may have been fortuitous! As had we been further forward and got pre-clinical data packages completed on the basis of NXP002 as a stand-alone drug any phase 1 clinical trials would have been scuppered by having no suitable patients available to test AND we would have been pursuing the wrong path re commercialization, based upon the now prevailing SOC treatment!
So it seems the company has had a ‘lucky’ break, re timing, and is able to further pursue the use of NXP002 as a combination drug, with very little/ no impact on future timescales or cost!

The sp is on the floor and long term investors pockets have been hammered.

Any chance of some positive action here soon.

Although AR has departed, presumably whatever outsourced activities and JH or DG activities carry on in the meantime. JH with 004 patents and 002 reformulation and DG with 002 development and commercial aspects.
So hopefully the second NXP004 patent will move from a provisional to a full patent submission quite soon with any additional findings from recent research incorporated.
The first NXP004 patent will hopefully be fully approved in the next few months, without any input required.

AB/ AR stated in the Proactive interview on 17th Nov 2021 that they’re next step was to talk to potential licensees – that was six months ago, so hopefully they did initiate talks and there has been some progress, if only getting it known to prospective parties. There should be a number of parties interested in NXP004.
They have now confirmed the enhanced performance and superiority of NXP004 compared to Olaparib and a lead cocrystal has been selected to enter drug product development. They state that “Further updates on NXP004 will be announced in due course”.
So sounds like there are things expected to happen here – so hopefully further news soon to expand on the rather too brief comments on 004 .

DG is already back into the company as a consultant.
Since AR effectively had to become interim CEO and Chairman on AB going and perhaps it has gone on too long for his plans.
Could it be that AR resigned with immediate effect to try to force DG's hand to pick up the CEO reins.

So few words such large effect!
So we have eighteen months of funding covering the planned studies, based upon current projections - which presumably assumes this low sp for Lanstead funds.
NXP002 now has a question mark against it which needs resolving and seems to effectively mean a nine month delay.
NXP001 moves forward with Oxilio unchanged.
No CEO found.
The only real positive seems to be NXP004 where they have confirmed the superiority of NXP004 compared to Olaparib and are progressing it saying that “Further updates on NXP004 will be announced in due course” - sounds like there are things happening here – so why are they not telling us any more now!!
I have stated for some time that I see a deal for NXP004 happening first ,either with the originator or generic competitors, and that seems more likely to be the case now.
The first NXP004 patent will hopefully be fully approved in the next few months and hopefully the second patent will move from a provisional to a full patent submission quite soon.
Also as stated in the Proactive interview 17th Nov 2021 they were planning to talk to potential licensees having filed the second patent.

"Just to be clear about this, licensing discussions with pharmaceutical companies take a long time and when you get to the beginnings of a deal usually takes six to twelve months for that to happen"
So we may be approaching that six month point now on NXP004 - who knows!
DG has presumably already had talks in Japan taking up where they left off two years ago before the pandemic.
So lots tom play for in two billion pound amrkets.
Apologies for corrected posts - fat finger syndrome with phone
ATB

NXP002 more quotesToday 09:59
Just to remind ourselves - further quotes from AR later in the same interview.
"These NXP002 results really do give the BOD confidence that this is worth investing in and that we will become very interesting to the industry ........ and that it will be given orphan drug status, which is quite important from a marketing point of view, and that two existing drugs for IPF each have annual sales in excess of 2.5 billion dollars"

Just to remind ourselves - further quotes from AR later in the same interview.
"These NXP002 results really do give the BOD confidence that this is worth investing in and that we will become very interesting to the industry ........ and that it will be given orphan drug status, which is quite important from a marketing point of view, and that two existing drugs for IPF each have annual sales of 2.5 billion pounds"

Proactive interview 26th Nov 2021 at 2:42 in AR mentions "We have also discovered during the studies we have been doing some interesting data which may lead to expanding our patent estate on this - this obviously builds (further) value into the product"
So is a further patent for NXP002 on the cards?

Proactive interview 26th Nov at 2:42 in AR mentions "We have also discovered during the studies we have been doing some interesting data which may lead to expanding our patent estate on this - this obviously builds (further) value into the product"
So is a further patent for NXP002 on the cards?

Good spot Filter29.
That they are now looking at website to update known/ declared data could possibly be the precursor to also preparing website for new unknown/ undeclared data to be released very soon!
That is probably how I would do it myself.
But that really is me just guessing!

Morning Mars1 - all I have done is quote statements made by Anne and Alastair in writing and interviews, as per below their verbatim words - watch the video guys to check, don't take my word for it.
Proactive interview 17th Nov 2021 at 4.14 minutes in, the interviewer asks “So whats your next steps for the drug Anne” Anne replies “Yes, so we plan to start to talk to potential licensees now we have filed that application and also, as I mentioned, potentially do a bit more work to supplement the filing, because you can do that with this provisional filing, and that will also strengthen the licensing package for the asset”.
Also, and separately, I have been directly told that they would not be waiting for patents to be approved before approaching the originators or potential partners.

There are a couple of significant issues that I am hoping to see RNS’d soon:
• The results of the NXP002 durability trials .
• Announcement that any further research associated with the NXP004 second patent has been completed and that the patent has been amended accordingly and changed from a provisional filing to a full filing submission. While they have up to a year to do this with a provisional filing, there is a commercial urgency to do this much sooner and I think 6 months on from the provisional filing we may now hear something.

Thereafter it would be nice to have RNS’s on the CEO situation and an overall update on all programmes – but that may have to wait for Final Results which is only couple of months away now!
Sorry for piece-meal messages and any errors, but writing on phone as my travel allows (business unfortunately).
ATB

Before spending considerable funds on clinical research it is a fundamental requirement that a company (Joanne Holland in particular and AB) carry out as full a search of existing patents around Lynparza as possible – examining any and all aspects that may preclude Nuformix patents being approved. Such searches are also carried out by the patent agent as part of the patent filing process paid for by the company. However there is always the risk that the patent office will find prior art or that a blocking patent has been filed just prior to the Nuformix patent. We will soon know regarding the first NXP004 patent.
Once a patent is officially filed then patent protection applies and the inventor can negotiate deals with potential partners with any potential deals being dependent upon patent approval being given.
Last year I specifically asked the company if it would be talking to potential partners on NXP004 once the second patent was filed or would they be waiting for patent approval. They replied that once the NXP004 second patent was filed they would be approaching potential partners. My only subsequent uncertainty with their statement is that since they filed a provisional patent does that mean that they could have already been speaking to potential partners OR does it mean that only once any additions are made to the provisional patent will they be speaking to potential partners?

Morning Soup
I totally agree that NXP002 is our lead drug and due to where it is in clinical trials and its approved patents it is well ahead of NXP004 in the normal pharma timelines, and with the announcement of Dan being taken on as a consultant - just one day after Japan opened up for business travel - then it seems a strong bet that he has already picked up from where it was last discussed – only this time with a lot more pre-clinical studies and formal data to show that it is a viable drug and with further reported studies re the efficacy of Tranilast for the treatment IPF and indeed Covid over the last two years.
However there is a distinct difference between NXP002 and NXP004 and it is those differences that make me wonder which will be the first to announce formal negotiations for a deal.
Whereas we are developing NXP002 as a new version of tranilast that is inhaled and for a new indication for the drug (ie IPF) and therefore needs a lot more pre-clinical proof of efficacy and satisfactory use. Whereas, I believe, for NXP004 we have patents for new co-crystals for existing indications for Lynparza, but where the new co-crystals provide better efficacy with less side-effects and with patent protection till 2040. So there are potentially a lot fewer unknowns and less risk to potential partners to sign up to a deal. Also there is the potential aspect of patent expiry looming and the risk that Nuformix could sell to another pharma who take overshadow their blockbuster moneyspinner with a better drug than Lynparza, one with less side-effects and improved efficacy.
TBC

NFT's I think your statements are right on the money - NXP004 could be massive.
Timescales are interesting as they could be talking to potential partners already (patent is protected once it is filed) or may be waiting until the further research is completed and incorporated into the second (preliminary) patent which could be about now. I doubt they will waste time waiting for the patents to be fully approved before talking to potential partners.
I strongly believe that significant good news is just around the corner on NXP004 and also NXP002.