Member Info for Mars1

Would think a complete set of IP is necessary for any deal more so than orphan status

Also bear in mind we are in a new tax year so will pharma R&D budgets be driven by tax relief or Financial year constraints. According to consultants pharma have the firepower this year.

Trans there is no easy answer to timing but you can look at the history all dates relate to RNSs

18/5 formal partnering for 002 commences suggesting the period before discussions were being held but probably more about requirements hence the delivery of the oral test results

18/9 raise to pay for additional data to support partnering process

18/12 partnering process continues for both products

1/3 wording changes to focus on discussions with licensing partners which suggests due diligence is complete

Same wording was reiterated in the Tim email last week with the emphasis this was the priority. Your guess is as good as mine.

My take of current events not that it is anything but guesswork is that the co is talking to AZ but they are not interested in repurposing although there is no good reason not to find better uses for derivatives of existing drugs so are not there for 002. So AZ are there for 004 that means a different licensee for 002. I think they will not retain any royalty income it will be a clean break. Then they will reverse Oxilio into the Nuformix shell.

Could also be an after market deal which will be reported in the am

Should have been down 5 to 8% today so the up is 13 to 16%

Something has caused this to be blue is it an off market deal mms do not mark stocks up for no reason.

PS I also meant to say that if the Ctte for the orphan application raises questions does the stock answer take priority ie the company is focusing on licensing discussions and will the orphan answers have to wait.

Soups last post was 13/3, the day before the last RNS from the co. He is not dealing with the licensees is he?

FX I see Olders post was 29th Feb which was only about 7 weeks ago. I read through his other notes at the time, co seemed keen to submit the orphan application at that point with an eta of 90 days so the end of May, that allows for questions from the Ctte. 7 weeks is not a long time for any govt dept so it may just require patience.

The only comment I have, is the stock answer from the co atm gives the impression that the only priority is liscensing discussions which suggests they are fully occupied. If the ctte raises questions on the application that extends the approval from 60 days to 90 days. I don’t think there is any doubt that IPF is a rare disease so it might be a cart and horse issue.

One question does arise is what keeps you so busy you cannot multitask ie pursue orphan status in addition to outlicensing. A huge part of the process is due diligence but providing data to be analysed by the counterparts does not create that pressure there are periods of high activity and then awaiting the outcome from activity from the other side of the fence. There may be other requirements that exist but full blown involvement is required looking at alternative results or legal agreements. Wishful thing I know

We certainly would but the reply from donttelltoomuchTim indicates they are too busy dealing with licensing to pursue the orphan application atm

PWC need to tell AZ

“Biotech acquisitions to fend off patent cliffs: Large-cap pharma companies will continue to face patent cliffs and gaps in their pipelines in the latter half of this decade and will look for M&A opportunities to achieve their growth plans. Small and midsize biotech companies that can fill in pipeline gaps in the back half of the decade will receive significant attention in 2024. However, the threshold rates of return which these acquisition targets must clear are now higher because of higher risk-free interest rates; as such, the competition will be fierce for truly innovative targets whose clinical differentiation is backed by good data.”

https://www.pwc.com/gx/en/services/deals/trends/health-industries.html

Maybe they need to tell the pharmas

EY 2024 Pharma M&A

“M&A targets: oncology and rare diseases

The huge growth potential of the oncology market is reflected in companies’ M&A spending over the past five years, with oncology dominating industry acquisitions in both value and volume terms…..

With legislation such as the IRA unlikely to affect the price point for orphan drugs, companies specializing in rare diseases have become significant M&A targets, “

https://www.ey.com/en_gl/newsroom/2024/01/deals-are-back-surge-in-life-sciences-m-a-fueled-by-sector-s-capital-reserves-and-quest-for-new-revenue-growth

FX that was true however one can only guess that they were advised by pharmas they were talking to, to prove the duration tests as inhalation was a new process for forms of Tranilast and this completed the data set. Of course increasing data sets would have taken time during the process which we have been told is 6 months +

Thought I would check back to see if I could identify when the co thought they were ready to recommence discussions. The first clear notice and the last separate update on NXP002 was 18th May 23. Since then we have had patent updates with notice that discussions are ongoing. Data sets have had to be increased. There would have been some initial foraging before the process started and delays with summer breaks but if things started moving in September it should mean activity is in the final phases possibly

“Following the success achieved in these studies the Company's next steps include:

· Expansion of the current studies to include tissue from further human IPF tissue donors to demonstrate the robustness of NXP002's anti-fibrotic response alone and in SoC combinations in multiple patients; and

· Formally commencing the NXP002 partnering process now that Company has the minimum dataset required to support NXP002's development as an inhaled treatment for IPF, for use alongside SoC's.

Commenting, Dr Dan Gooding, Executive Director of Nuformix, said: "I'm absolutely delighted with the data we've generated over recent months - all the results we've achieved are as good as we could have hoped for and are the first results from advanced 'close to patient' IPF and inflammation human tissue disease models. The inflammation data was perhaps expected given past results but provides further support of NXP002's potential to deliver increased performance on top of existing standards of care. However, the positive duration of action data is a first for the NXP002 programme and allows the Company to discharge one of the programme's last remaining development risks that hasn't previously been addressed.

"The combined data gives us great confidence in NXP002's potential as an inhaled therapy for IPF treatment and allows the Company to tell a more complete pre-clinical story to potential licensing partners for the first time. We will now look for opportunities to share this important new data with key players in the rare disease and respiratory disease sectors as we explore all opportunities to progress the NXP002 programme."

The other interesting point in the reply is that they are in discussions with more than one potential licensee

FX not that vague. The answer is it has not been granted yet, so the application is in, it can only have a possibility of been granted if it is applied for.

It also means that the application could have been made anytime after 3rd January RNS

Just seen that orphan designation applications are free from fees so that scuppers the reason for the raise unless they needed consultation input for the application

From the 3/1 results RNS -NXP002 is a likely candidate for Orphan Drug Designation, which could provide additional product protection against potential competitors.

The raise on 1/3 was funding to progress NXP002 discussion with partners and progress NXP002 development so was that partly for the fee for the application for Orphan status if so estimated submission date is mid-March.