Member Info for CauldStream7

Loads:

There are many of us, like you, facing huge losses, if the company were to go under or be taken over at the present SP. But its clear from Oscar22's posts that this is very unlikely to happen. There are just too many of the senior management/directors/founders who hold large bundles of shares, to let this happen if at all possible.

As to Tim McC and his happy-clappy interviews in past years upon which little confidence could be put, I detect a change in the past year. First, information via RNS notices and Proactive interviews featuring Tim, have been more frequent. Second, they contain more detailed information than in the past about we can expect by way of progress in obtaining FDA approvals and in relation to negotiations with other pharmas for the financing of ROW Lupuzor and for North America and ROW CIDP trials.

Moreover, we have been getting on this board clarifications and analysis by a contributor calling himself/herself Oscar22. It is obvious that whoever this person is, they have much more information than the rest of us about what is really going on within IMM.

For proof, read Oscar's post about Tim's latest Proactive interview. It summarises it into about 9 different headings which actually contain more information than Tim supplied in his interview. Obviously, he didn't have time, or her forgot to mention them all! If you doubt me, listen again to the interview and compare it with Oscar's summary (dated I think, 5th July).

So thanks Tim and thanks Oscar22. I'm encouraged to hold my shares, optimist that I am! And cheer up, Loads!

Lambo:

You are a needle stuck on the same groove of an old record.

As Oscar wrote in his summary of Tim's Proactive interview summary last week, and reiterated yesterday, Tim is convinced that IMM's finances are "robust" and sufficient until 2024. So just use your eyes and read what has been stated on this bb by Oscar who obviously has an inside track as to what is going on in IMM.

I think we are now in a much better place than in previous years when Tim's claims of ROW Lupuzor deals being under discussion had to be taken with a pinch of salt. Now, Tim is actually sticking his neck out and indicating that one or two deals are expected to be signed before the end of this year, one for Lupuzor and one or two (North America and ROW) for CIDP.

So please give up rabbiting on about a 2p share placement. It's not going to happen if Tim and his board have anything to do with it.

Loadsof.....

IMM has no intention or wish to sell out to Avion and as far as one can assess the present actions of Avion and IMM, the former has no intention or desire to buy IMM.

The summary of Tim's Proactive interview supplied last week by Oscar, makes that very point. Tim believes that IMM is on the cusp of major development through agreements with other pharmas for the ROW rights to Lupuzor, and to North American and ROW rights to CIDP. These agreements will involve upfront payments to IMM, says Tim, that will leave it with plentiful cash for its own remaining pipeline and provide uplift to its SP. He made it clear that he wants to change the background of an ultra-low SP as soon as possible.

There are plenty of examples in history of such dramatic changes of fortune, so don't denigrate IMM's efforts.

Avion:

Thanks for your summary of the CEO's interview last week. It is all very positive but I'm left with some questions.

1. What is the timetable for completion of the Phase 2/3 trial?

2. Until there are clear signs that either the Lupuzor or the CIDP trials are completed AND successful, what upward impetus to the SP will take place?

3. Are there any other pharma products in the IMM pipeline which will be ready for the market before Lupuzor and/or CIDP such as BioAMB which have gone off the radar for a while?

As things stand, the market is not yet impressed with IMM's outlook. Let's hope that changes soon.

Apologies WILDBUNCH for misspelling your name. And thanks for explaining your nom de plume.

Wildbush

In my point about CIDP, I meant to write "how confident Tim was of finding a partner to finance the CIDP trials". And that is why I can't understand why you replied to my question on this that he referred only to Lupuzor not CIDP when discussing the next stage of trials.

Wildbush:

Thanks for your clarifications, but I am still puzzled.

From the previous interviews on Proactive, Tim made it clear how confident of finding a partner to finance the CIDP trials.

As far as Phase 2 is concerned, which you say is for Lupuzor, since Avion is already committed to financing Lupuzor in the USA, I presume that you mean the Lupuzor trial in the ROW.? Would it not also be a Phase 2/3 trial similar to the one agreed with the FDA?

Forgive me for all these questions. I am an ignoramus compared to Nolupus as far as IMM is concerned.

Wildbunch:

Thanks for sharing the info you have from the AGM.

However, there are a few points within your info that are unclear to me

First. You say that IMM is advanced on finding a partner to manage Phase 2. Is this Phase 2 of CIDP?

Second, the statement of the Lupuzor 2/3 trial taking 3 to 4 years. OMG; that is much longer than I anticipated. And what does "Going towards 3 years "if outstanding date shown in Phase 3" mean?

Third, is "expectation rather than hope" a good sign? Do you mean that any agreement with a partner to finance the CIDP trial process, and/or a similar agreement with a partner to advance the ROW rights for Lupuzor, is likely to contain a clause to pay IMM a lump sum on signing of the agreement?

Fourth, the $5 payable on acceptance by the FDA that Lupuzor is an acceptable drug for use against Lupus is surely at least 3 or 4 years down the line because it will only happen after the 2/3 trial is successful. So how that does help any short term need for funding for IMM?

Wildbunch: Thank you. That is very welcome news. I hope you will have time to supply a few details in the near future.

Let's hope that happy days will come soon. ATB

Wildbunch: I totally agree with you. Like you, I emailed IMM a few days before Tim's latest interview to clear up the ambiguity (not that I saw any) over whether Avion would fund the 2/3 trial. To my mind that was never a realistic possibility; it would have been a clear case of cutting off one's nose if they had.

I suspect that many shareholders and non-shareholders who fulminate about Tim McCarthy realise that the FDA has made IMM and Avion jump through various hoops like the PK study before giving their approval to the new adaptive study and have also forced/persuaded both IMM and Avion to adopt a much higher dosage rate and frequency of administration than the two firms were advocationg.

But as Tim has said, it pays to listen and cooperate with the FDA who now seem to be in complete agreement on the road ahead. As Tim said in his interview, IMM could be on the cusp of a very major development which will be reflected in a large improvement in its SP.

No doubt I'll be accused of being a hapless stooge of the IMM cause. We shall see.

By the way, during that interview, Tim often repeated the phrase "few years", not "two years" when describing the passage of time between the original agreement between Avion and IMM and the present one. Nothing wrong with that is there?

At the very least, this interview should have silenced the doubters that the original agreement with Avion for financing the Phase 3 Lupuzor trial did not apply to phase 2 of the newly approved FDA adaptive 2/3 trial. I'm glad to have been proved correct that it would have been nonsensical if it had been so. Avion will indeed pay for the entire adaptive 2/3 trial and their preliminary costings indicate that the $25 million budget for the trial still looks sufficient to cover the costs of the new trial.

Lambo:

It has been emphasised by IMM that the FDA has approved an adaptive 2/3 trial, meaning that having determined the optimum dosage for client treatment in Phase 2, they can proceed to phase 3 without having to obtain any further approval from FDA. This would considerably reduce the time required to complete the combined trial.

In any case, Wildbunch will be at the AGM to ask Tim to give us a timeline for commercialisation of Lupuzor which would include the time required to complete the 2/3 trial.

Wildbunch:

I omitted the work "funding" from the first line of my first question .

Wildbunch.

If you do attend the AGM, please ask the following:

Where is IMM going to obtain from to meet its expenses over the period, (18 months?) until it receives its first contractual payments from Avion?

2. In his interview on the 24th May with Proactive Investors, Tim McC expressed his satisfaction with the great amount of interest amongst big pharma companies in partering IMM to commercialise Lupuzor in the Rest of the World outside North America. This is just the last of many similar statements so they are losing their credibility. Can he now put a date on when a deal will be signed with another pharma and will it include a downpayment to IMM to ensure its continuing viability as a going concern?

3. In the same interview, our Chairman said there was real enthusiasm amongst the pharma community for the potential of IMM's P140 peptide to provide improved treatment for CIDP. Another month gone by- where has all this enthusiasm gone? When will it result in a partnership with IMM?

Michael2021

In my opinion it's too soon to say that you will not get your money back if your average SP is 25. In the not so far distant past, that price would have been regarded as low.

Few if any investors back in 2018 before the failure of the last Phase 3 trial failure was announced, would have imagined where the price would be now. Even a year ago, with the price over 5p, I did not foresee that the price would fall below 2p. Let us suppose that the new adaptive 2/3 trial for Lupuzor is successful, not too fanciful a supposition, and that the CIDP trial is similarly successful within the same time frame, ie. around the end of 2024, a price of 25p will be in the rear view mirror. That is my expectation, and not just a forlorn hope as some might characterise it.

My main fear is that IMM's Board will recommend a takeover which will be at a SP below 20p which will leave long term shareholders like us out of pocket. I think this is still unlikely if the Lupuzor and CIDP trials are going well.

Nolupus:

It is clear that IMM and Avion have had to accept the FDA view that much higher dosage rates were required for the next adaptive 2/3 trial. I think they accept their past mistakes. Who could have known beforehand that their chosen dosage rates would be too low to treat some types of Lupus?

Were these mistakes arrogant? Perhaps, in that it would seem that it was only strong pressure from the FDA that persuaded IMM and Avion to accept these much higher dosage rates. I am no pharmacist, but the logic of the situation indicates that both FDA and Avion/IMM believe that Lupuzor now stands a good chance of success in the upcoming 2/3 trial.

Nolupus:

Thank you for your apology.

Thanks Frits for your encouragement. We all need that from time to time.

Actually, I do firmly believe in the strength of IMM's science and in particular its leader, Prof. Sylviane Muller. And I still continue to accumulate shares albeit on a small scale. So even if at times I despair, I still believe.

Is this what Nolupus defines as following IMM dogma?

Nolupus.

I am sorry to have caused you pain by my comments. And thank you for clarifying the significant meaning of your nom de plume.

And for the record, I first invested in Lupuzor because I believed it held out real prospects of curing autoimmune diseases from which two of my children suffer.

I do not slavishly follow anything as you allege, and certainly not IMM dogma. You might explain what you mean by IMM dogma and cite some examples of my slavish following of it. Can you, and if not, can I have an apology?

I think that yesterday's RNS marks a significant milestone for Lupuzor and I'm surprised that the market's reaction is a damp squib. The only upside is that I can still add modest amounts to my shareholding without breaking the bank.

What I find most interesting is the evidence of a joint discussion between FDA and Avion/IMM about the trial protocols. There have obviously been compromises on the protocol. On the side of Avion/IMM there has been acceptance of the FDA's preference to take advantage of Lupuzor's safety record to use a much higher dosage rate for patients taking part in the adaptive Phase 2/3 trial. On the FDA side, they have accepted the preference of Avion/IMM for delivery via SC (as you have pointed out).

This collaborative approach suggests to me that there is now a much better chance of success in this new trial than in the Phase 3 trial in 2018.

Nolupus:

You are a highbrow version of Lambo. You have been peddling doubts about the efficacy of Lupuzor for several years. Even your nom de plume seems to indicate that you don't believe there is an actual disease that goes by the way of Lupus. Instead, in the past your view seemed to be that Lupus is a syndrome of various illnesses that have similar symptoms but different underlying causes. Thus you believe they cannot be treated by a single treatment like Lupuzor.

In this latest case, Avion/IMM is being critised by you for what they have not said rather than what they have. Why would they have done so when for months they have clearly stated the a Phase 2/3 adaptive trial should be treated as a single trial, not two, because they can move on from Phase 2 to Phase 3 without obtaining any further permission from the FDA.

So don't tell us that your feelings have been hurt because I have called a scaremonger. When it has suited you that is the role you have chosen from time to time going back years.