Member Info for YoungHarry

Not quite I agree but near enough. The market interest is in the HAV results and the farm in deal, the rest as freestanding assets don't count for much...yet.

The valuing numbers caught my eye are worth a further look.

'If the find is commercial, the price of gold is cUSD1300+ and estimated AISC of USD800, each oz of gold is worth USD500 or USD500m for each million ozs. That is worth USD125m to GGP and USD375m to Newcrest.

This assumes GGP sell 5% to NC, if not then GGP's share would be $150m US per 1 m oz or circa £120m.

The current market cap of £52m therefore assumes 1m oz of recoverable gold at a 43% discount.

Given HAD005 is a world class intersection on the up side and that 10m oz discoveries are v rare, it is reasonable to bet the find will be nearer 5m oz than 1 or 10.

Navid Malik has through a presentation of data and reasoned analysis identified the critical parameter for patient selection in a second PIII trial to be the anti-ds DNA auto anti body level – a marker for both diagnosis and efficacy.

Further to a review of critiques of previous PIII trials and published proposals for more effective Lupus trials, he proposes a new paradigm for the second PIII trial design.

Old model: double arm with a mix of patients with and without the anti-ds DNA bio marker = weak clinical effect

New model: single arm, all patients with the bio marker – high response rate

Evidence has been presented to the FDA about:
- The reliability of clinical end points in studies grounded by complexity of outcome measures
- Heterogeneity of the disease / spectrum of disease best approached through a precision medicine approach
- Superior and high compliance to medication in the clinical trial setting – not a real-world adherence to medication – risks over performance of the placebo arm

The 2019 EULAR recommendation for management of SLE notes that clinical trials need to:
- handle background medication to avoid polypharmacy and can result in dilution of the positive effets of the drug under study
- consider inclusion of organ specific end points and disease activity measures.

From the above it can be concluded that advise IMM is seeking from its regulatory advisers concerns a pathway towards approval for its second PIII trial based on:
- Patients with the bio marker
- Assessment of the right primary end points
- Assessment of the right standard of care

Small wonder potential partners are in discussions with IMM, they are going to have come up with some very punchy terms. Small wonder Navid has set a target price of 92p

I like this post so much I posted it again...
It could be argued this interview provides investors with the most significant news since the PIII read out.
First, it provides a third party endorsement of the Board's view that Lupuzor will reach the market.
Second, it explains this endorsement by arguing a second PIII trial with patients who have 'the true Lupus condition' (ie those with high levels of anti-ds DNA positive) has a real prospect of success.
Third, it refers to the responder rate of 71.% among the European cohort of patients with the above biomarker. A response rate not achieved in any other Lupus PIII trial. This is of course a cohort within a cohort and the responder rate was 35.7% among the equivalent US cohort. However Navid argues a PIII trial could combine:
I) A better targeted patient group: the target patients being those with the biomarker who account for around 70% of the Lupus patient population (in the PIII trial this group on active accounted for 58.5% of the Europe cohort (actual 38 out of 65) and 38.9% of the US cohort (actual numbers 14 of 36)
2) A more helpful regulatory regime with evidence of a pragmatism around end points and trial design.
On this basis it is easier to understand the company's confidence in Lupuzor and prospects for a licence deal and second PIII trial

It could be argued this interview provides investors with the most significant news since the PIII read out.
First, it provides a third party endorsement of the Board's view that Lupuzor will reach the market.
Second, it explains this endorsement by arguing a second PIII trial with patients who have 'the true Lupus condition' (ie those with high levels of anti-ds DNA positive) has a real prospect of success.
Third, it refers to the responder rate of 71.% among the European cohort of patients with the above biomarker. A response rate not achieved in any other Lupus PIII trial. This is of course a cohort within a cohort and the responder rate was 35.7% among the equivalent US cohort. However Navid argues a PIII trial could combine:
I) A better targeted patient group: the target patients being those with the biomarker who account for around 70% of the Lupus patient population (in the PIII trial this group on active accounted for 58.5% of the Europe cohort (actual 38 out of 65) and 38.9% of the US cohort (actual numbers 14 of 36)
2) A more helpful regulatory regime with evidence of a pragmatism around end points and trial design.
On this basis it is easier to understand the company's confidence in Lupuzor and prospects for a licence deal and second PIII trial

TLSD is a specialist investment bank to global life science companies.
The 42 page report on IMM contends Lupuzor will reach the market through, most likely, a 2nd PIII clinical trial targeted to patients who are selected on the basis of precise medical application for the spectrum of disease through clinical bio marker of severity. It identifies UREKA as a potential disruptive therapeutic platform with a key advantage over competing technologies as evidenced by the GLP-1 candidate molecule.
The report author is Navid Malik who old IMM hand will recall was at Cenkos Securities. The report - available only to institutional investors - is a marketing communication based on non independent research. But then is company research ever truly independent?

Key points summary
Just under £5m cash at year end
Lupuzor: pursuing a number of discussions, finding right path to market, still has opportunity to be a blockbuster
Nucant and Ureka: lot of interest, route to the value to be recognised, move the programmes and add value
Extension study: on track to report end of H1
'Life Sciences Division' Research Note: price target 92p (that's the share price not the research note), highlights:
- advantages of Lupuzor - mode of action and safety profile and lack of market competition
- potential to target patient groups (presumably the ds DNA anti body group) and refine PIII trial design
- Ureka
News flow: Extension study (we will see these before the AGM for sure) and within next 12 months Lupuzor discussions and Nucant / Ureka spin out.
Scott was too polite to mention Incanthera.
The market isn't going to take the BoD's word for the potential of Lupuzor (although I do) until a partner commits and when one does, the sp will fly.

The next IMM AGM is due to be held soon and I'm wondering what achievements the BoD will have to present to shareholders. Here are a few things we can be certain they will not be planning to present:
a) Enterprise value: market cap is down from around £38m this time last year to circa £14m today.
b) Investments: £2m of cash invested in Incanthera, an unlisted company with a post money valuation of £13.33m
c) Directors remuneration: Unadjusted to reflect failure to meet PIII trial end points (which can be argued reflected failures in recruitment and power)
Some would view this as shameless conduct in the light of the PIII trial results, flawed decision to invest in Incanthera and destruction of the company's enterprise value.
On the plus side, the BoD may wish to bury all of the bad news and treat shareholders to a full explanation as to why they remain focussed on achieving full regulatory approval of Lupuzor: Here are some clues...
a) The PIII data (full analyses were expected in October last year) so full data should be the subject of a peer reviewed article before too long
b) Extension study, results due end of June
c) The prolonged discussions with commercial partners
d) The Nucant / Ureka liquidity event
e) Exploratory work with P140: Speculation on my part but the PIII data may have identified clinical impact for patients with other auto immune indications, this may explain c) and d) above as routes to progress further work to bring other indications 'into the clinic in due course.'
To remind ourselves: Of the 202 PIII patients, 107 had the ds DNA anti body positive bio marker. The responder rates were 61.5% on active and 47.3% on placebo, a clinical impact of 14.2% and a p vlaue of 0.0967. In the Europe cohort, the responder rates were 71.1% on active (27 of the 38 patients) and 48.8% on placebo (20 of the 41 patients) a clinical impact of 22.3% and a p value of 0.0218. In the US cohort, the responder rates were 35.7% on active (4 of 14 patients) and 42.8% on placebo (6 of 14 patients) a clinical impact of (7.1%).

On Dallo's scenarios:

1 Lupuzor
A partnership with a large Pharma to develop Lupuzor: IMM has clearly signalled a deal is under discussion, to the extent they have postponed the MAP. Having spent time in the data room, it is possible the party has reasons to be attracted by the opportunity to trial Lupuzor on other indications as well as Lupus. A deal with a pharma with credibility to progress to another PIII trial would trigger a rerating of the sp.

2 Elro Pharma / Ureka merger
A trade buyer found or an announcement to float on European Stock Market: IMM have clearly spent time assessing the potential of the Ureka peptide platform and optimal route to realising value from this and the Nucant programme. A float is the more likely outcome as IMM could take forward the drug development programmes.

3 Extension Trials
A positive result from the limited Extension Trials. News of a possible deal during the late stages of the study could be linked. However, the results will be of limited value as the number of participants is small and it is not a randomised double blind study with a balance between patients on active and placebo.

4 Incanthera
Incanthera announce a date to float on AIM. Only a genius could put a positive spin on spending £2m on an unlisted company with no early possibility of an exit. Utter madness, what on were the directors thinking?

5 Offer for Immupharma
A bid for the entire company for a price that would be petty cash for a large Pharma: In our collective wildest dreams. Zimmer isn't selling, he'll take his shares to his grave and beyond.

So we live in hope: 2 a real possibility within say 12 months, 1 a possibility. More news has been flagged for the end of the month, ie next week and after that a AGM is due as are the Extension Study results. All fuel to power the sp pending announcement re deal and float.

For the avoidance of doubt, the reference to the 'rest of the pipeline' should have read, 'rest of the pipeline excluding Lupuzor / P140 platform.' So £10m pre money for the above in addition to the value of Lupuzor / P140 platform.

Today's RNS hints at IMM becoming a two deal play in a much faster lane than that offered via the MAP. The latter being a low cost but time consuming way of collecting data to attract a partner / funding for a further trial.

I) A possible corporate deal under which the partner funds and takes forward the P140 platform through a series of say PI trials (if they want to reformulate the drug) or PII (if not) with IMM collecting milestones along the way and, subject to FDA approval, royalties from sales. The references to P140 platform in the main body of the RNS and notes to editors giving a strong clue as to the focus of interest. Further evidence to support this was given at the AGM that the results in respect of 'other indications' were interesting.

2) A market valuation of a new company combining the Nucant Programme with the peptide platform technology either through either private equity investors or a listing on a European stock exchange

Such deals would give the market greater visibility to IMM's value and investment potential. Those who heard Vadim Alexandre discuss the value of 'rest of the pipeline' could agree that a valuation of £10m pre money would be reasonable.

Should the above speculative comments come to pass, the IMM could be subject of a rerating.

Here he goes again, one man vendetta against Lupuzor, IMM, Tim and so on.
Must be eating you up, what a way to spend your early retirement. Grow up, get a life and move on.

A few answers to your questions.
Data from the PIII trial is expected by mid August, full analyses mid October and answers to key question mid December, data to be published in peer reviewed scientific journals. The findings to inform presentations to regulators. The key matter is whether or not there is a clear scientific explanation for the low level of US bio marker responders on active. The Merrill study provides a clue noting control of steroids is very important to testing efficacy of the active drug. As you know only 5/14 of the above US patients on active were responders, based on the Europe responder rate, the expected result would have been 10/14. So it all hinges on what went on with the 9 non responders on active. If steroids or other elements of the SoC provide an explanation, there is a route for an application to the EMA for a conditional temporary approval. With such approval, IMM could progress a second PIII study with 200 bio marker patients with regulated steroid dosing. I trust you find this summary more helpful than merde.

IMM may have something to announce soon in respect of closing recruitment to the OLS.

The forecast was first published before the PIII read out and based on the assumption the trial would meet its primary end point. The current questions are how much is IMM worth on the basis of the PIII secondary data in respect of patients with positive ds DNA auto anti bodies a) prior to a licence deal and b) after such a deal? In respect of a) the market is saying £32m but of this only £12m is for the Lupuzor data room and patents (after deducting cash, £25m in tax losses and say £3m for the rest of the pipeline). This suggests the market is betting on a 1:3 - 1:4 chance of a deal for markets caps and share prices of £56 - £68m or 40 - 49p per share.

The post on the web site posted 6th June 2018 Patient name timwatt561, age 31 years, location Mauritius States, disease lupus pneumonitis, started 1st September 2017 (presumably this refers to the drug) and comments, 'another ten on trial clear of Lupus at present.' This raises interesting questions concerning: - treatment: last dosing was end of December so first dosing should have been at end of January, not 1st September - placebo: as discussed widely, responder rates on the placebo may have been inflated by the ability of patients to swap notes through the Mauritius Lupus patient network - clinical effect: last dosing was in December and yet the claim is that 11 patients are still clear of Lupus Before credibility can be attached to the timwatt post, we need to see posts from other patients on their experience.

The company has promoted a narrative that the PIII study failed due to the high placebo rate. This line doesn't work when you consider that the Benlysta BLISS 52 study had the following responder rates, 60.8% on active and 48.5% on placebo (against the PIII study responder rates of 52.5% and 44.6% respectively). Interestingly, the company narrative about the anti ds DNA antibody patient results is all about the higher responder rate on active of 61.5%, no need in this case to blame the responder rate of 47.3% on placebo (which is higher than in the study as a whole). Note the similarities between the BLISS 52 and ds DNA patient results in percentage terms, however BLISS 52 met the end point because it was the subject of a powered study. This makes it clear that a powered study is the way to go.

NKOTBUK From memory the US patent for Lupuzor runs until 2027 and 2032 for the other indications. As a patent runway to 2032 is very much more attractive to putative commercial partners than one to 2027 and IMM are otherwise engaged in fattening the goose, it follows they will be looking to find a way to extend the patent life for Lupuzor to 2032.

Sorry fat thumb the new reality is the P140 platform can only be taken forward by a big pharma. In the light of this they appear to be packaging up the platform for a deal by carrying out further data analyses, running the open label study and preparing for discussions in respect of a new regulatory pathway. They may also undertake work required to extend the Lupuzor patent life in the US. The question for investors is then not will they do a deal but do any pharma want to do a deal? It's not a certainty but there appears to be something interesting in the ds DNA data and there is some encouraging pre clinical data in respect of other indications. Investors buying in the 20s are taking a risk but could be rewarded on a 12 month view.

NKOTBUK It is a little unfair to suggest that RZ / DD are wholly tied their (what is now a failed) go it alone strategy, after all they did licence Lupuzor drug before. Further, give the gents credit, they set up this company and have taken a drug to PIII whilst retaining 100% ownership. They are then bright enough to recognise the realities of the post read out era, lasie tehm