Member Info for CauldStream7

Nolupus. You are scaremongering when you suggest that Avion might not be prepared to finance stage 2 of the new adaptive 2/3 Trial. It has been stated in previous RNS announcements, that the adaptive 2/3 Study is the preferred option of Avion and IMM, instead of separate Phase 2 and Phase 3 Trials. Now that FDA has agreed to that and to the trial protocols based as much on the FDA proposals as on Avion's, it is inconcievable that Avion would now sit on its hands and

do nothing until a separate funder for the Phase 2 part of this new adaptive trial has been found.

How absurd a position to take when one considers the time and great expense that Avion has already spent in getting FDA approval to start the adaptive 2/3 trial.

Nolupus.

To judge the importance of a scientific discovery by the number of employees involved in the lab and behind-the-scenes work is daft. One Sherlock Holmes is worth a 1000 plods on the beat.

In any case, P140 was discovered around 10 years ago by Prof Sylvane Muller so what does that have to do with current employee numbers at CNRS?

Nolupus:

My assessment of the relationship between CNRS and IMM is not overblown. I believe that it is not one of thousands of the same between CNRS and other companies. The agreement for the sharing of patents relating to P140 is of major importance and could have huge implications for the health of millions of sufferers from diseases of the immune system, as well as the earnings of IMM and CNRS through its licensing agreement with IMM for the P140 patents.

Oscar22.

I appreciate your analysis of IMM's strengths and the excellent prospects the company has of success in the use of the P140 platform in treating two autoimmune diseases, Lupus and CIDP.

Another reason (not mentioned by Oscar) to believe in the wide potential of IMM's peptide's platform, is the strength which the company derives from its exclusive right to commercialise the discoveries of France's principal scientific research institute, CNRS. And so, on its scientific team it has Prof. Sylvane Muller, one of the research directors of CNRS, and inventor of P140.

Eventually, and likely within 2 to 3 years, we can expect a further roll-out of the P140 as an effective treatment of other autoimmune diseases such as asthma, which have huge market potential.

Moreover, IMM's link to the CNRS, may ensure that IMM remains true to its mission to bring to market a wide range of treatments based on the P140 platform and prevent it from becoming an easy prey to large pharma companies with deep pockets.

Returning to Oscar's post, it would be a rash person who would contradict his evident confidence that Lupuzor will get FDA approval to proceed to a Phase 2/3 trial on the basis of its protocol and that the trial has a very good prospect of success.

Wildbunch: Like you, I have been very happy to let the short-term traders keep the price dotting up and down just above the floor. It allows me and I'm sure many others to accumulate bit by bit at absurdly low prices. Low anyway in my estimation given the hard science and experience behind P140 and its derivant, Lupuzor.
I'm obviously looking forward to the CIDP meeting with the FDA on 16 May and the Lupuzor meeting on 7th June for important positive news for IMM. Additionally, I am hoping to see an RNS about a financial and licensing deal with a larger, richer pharma to finance the Phase 2/3 trial for CIDP. That is the real trial of Tim McC's capabilities.

llofl: Let's look at the content of the last 3 RNS announcements. They state quite simply the steps being taken with the FDA to obtain approval for the protocols for the final Phase 2/3 trials of P140 adapted for Lupus and CIDP respectively. They signal progress not promises. I fail to see anything other than statements of facts from which I derive encouragement that these Trials will begin in H2 2023. Nothing misleading there.

How could the retreat of the SP have anything to do with either Tim?
Even a shallow understanding of where we are with Lupuzor and P140 should make it clear that the Tims have little to do with the submission of the protocols for these drugs entering into Phase 2/3 trials. In the case of Lupuzor, it is Avion and its scientists, aided by IMM scientists, who have prepared the protocols for testing the drug. If the Type C meeting on 7 JUne with the FDA does not lead to agreement with the latter, it will be Avion that will be at fault, not IMM or Tim McC.
Likewise with CIDP, the preparations for the meeting with the FDA on 16 May have been in the hands of Immupharma Biotech in France, not Tim in London.
What we are seeing is short term traders/speculators trying to make money out of small price movements. Some will succeed, others will lose, in equal numbers. What is clear is that they are NOT interested in the science behind IMM/Avion's design of Lupuzor trial protocols.
I wouldn't try to join in their games; I would be a minnow amongst sharks!

draye: There was news of CIDP on 12 April, namely that a meeting with the FDA has been arranged to discuss the upcoming trial of P140 to treat CIDP.

The latest 3 RNS annoucements from IMM all point in one direction. Progress towards Phase 2/3 Trials for 2 applications of the P140 peptide platform. I refer to Lupuzor for Lupus and another formulation of P140 for CIDP.
You would think that anyone who takes an interest in the science behind IMM's new drug candidates would either buy shares at the present lows, or at the very least, delay selling until it becomes clear that BOTH drug candidates were likely to fail.
But no. There is little let up in the number of sellers who are more or less in balance with buyers.
I think the answer must lie in that there are two types of buyer and seller for IMM's shares. The first type, are those who believe in the excellence in the science behind IMM, namely the discoveries of senior researchers at France's leading pharma research centre which has given the franchise rights to IMM to commercialise them
Then there is the second type of buyer/seller who regards IMM shares as a commodity to be bought and sold on a daily basis, just as one would trade commodities like copper and rubber. These traders regard IMM as one of several commodities/shares which they can trade, making their profits on often small differences between the prices they have bought and sold at. It is fair game for them to spread any rumour and lie to either depress or improve sentiment about whatever they are dealing in in order to improve their trading profits.
In the short term these trading effects on the IMM sp can hurt the company because it impacts for example on how much they receive from Lanstead but in the long term, if IMM has got its science right, it will prosper.
Having held IMM's shares for many years, that's what I believe. It's also what I want to believe: 2 of my children suffer from autoimmune diseases, in one case severely so.

Nolupus:
What are you referring to " in the current fundraising". I have not heard of any current fundraising. And where is there any reference to the latest Lanstead and L1 warrants being exercisable at a price lower than 11p?

Nolupus; that's a good point about Avion's support for IMM. It could mean that they will do a similar deal for a Phase2/3 trial for the use of P140 for the treatment of CIDP as they have done for Lupuzor for Lupus.

Nolupus. I agree that IMM needs to show that it can finance its pipeline development products incl, CIDP, BioAMB, etc about which there has been no news since the publication of the Interim Results on 30 Sept, 2022.
Oscar22 suggested that the finance IMM needed would come from the revenue it would make from finding sales for Avion's FDA approved drugs in Europe. But as I asked him, what track record has IMM got of selling anything, let alone proprietary drugs for an American company. Am I alone in my lack of confidence in IMM's ability in this area?

Oscar22. Thanks for summarising the potential for short term inflows of money from earnings. But I can't take this without a large dose of salt. IMM has consistently failed to achieve deals for selling the rights to Lupuzor ex-USA despite being repeated assurances that a deal is close. CIDP - we were promised that this might reach a P3 result ahead of Lupuzor but this seems to have disappeared from sight.
As for selling Avion's successful drugs ex-USA, I don't see how IMM can manage, lacking as it does any sales force or sales structure. After all, this is not what IMM was set up for. Unless Avion is prepared to send some of its salesmen to Europe to help IMM to set up and train a team or teams of sales people to sell Avion's specialist products, I'm afraid that this prospect for IMM earning substantial fees, royalties will remain just that, - a prospect that recedes with time.

Oscar 22. Your posts seem much better informed than those on any other contributor to this BB. Based on your posts, the future for Lupuzor looks bright, but only if investors are prepared a further 3 years for final FDA approval. According to you, we can expect the Adaptive Phase 2/3 trial to begin in H2 2023, approval of the Phase 2 phase in 2024 and completion of Phase 3 in late 2025, with FDA approval presumably arriving in 2026 - ie 3 years from now.
Even for long suffering IMM investors, that is a long wait, and although the propects of FDA approval look bright, there is no certainty in this business.
I guess this is why the SP is so low. Investors have begun to realise that it will be a long wait before Hallelujah day arrives and many are voting to get out even at rock bottom prices.
With all Oscar's optimistism and his/her Strong Buy recommendation, there is no mention of the likelihood of interim cash inflows for IMM, such as a successful CIDP P3 trial, or collaboration with larger pharma companies that will yield upfront payments. No mention of any income flows from the agreement to market Avion's drugs in Europe, so no short term good news for investors.
So a wait of 3 years before FDA approval of Lupuzor with all the risks of a cheap buy-out, or a failure to meet the P3 outcomes, etc, etc, is bound to dampen the spirits of even the most loyal longterm IMM investors.

Oscar22. While I agree with you, it is likely that you will be submerged under a load of people decrying your views as hyperbole. Why they can't read the RNS news dispassionately I don't understand. Perhaps they are only in the business of making short term gains by jumping and pumping.
Like you, I believe in the solid science behind the P140 platform. Only time will tell but I feel that within a year or so some of us will be saying "I told you so" and others will be either red-faced or pretending they always backed IMM.

Nolupus - thank you for advising us to google Saphnelo. I have just done so and after reading of all the possible side effects of the this drug, I would run a mile before taking it.
Lupuzor with its lack of side effects will surely be the preferred if it reaches its P3 objective.
In my view, the failings that maidit308 enumerated about anifrolumab ( trade name Saphnelo!) are very valid whatever name you give it.

Jenforluck; Absolutely agree with you. The agreement between Avion and FDA on the Protocol whereby all prospective patients in the new P3 Lupuzor trial will be pre-screened so that only only those with positive biomarkers for Lupus will be included in the trial is an indication of the productive negotiations that have been going on between the two organisations beforehand. Therefore, I would be very surprised if FDA does not agree with Avion's proposals for the new Phase 3 trial. The research note by Stanford Capital Partners explains all this in greater detail and deserves a close read. I think it is very positive for IMM.

Like Notaflipper, I thought today'sRNS was an excellent piece of research and a timely estimation of the fair value of IMM's shares. At the present valuation of 37p that seems much more realistic than the ludicrous estimates of 20p, and lower, featured in some of this BB's poster boys. And unless one needs the money, why sell now when in a couple of years time we could be looking at a share price of at least twice as high if the P3 trial comes up trumps?

Leas - We are in a different ballgame compared to the situation in the Spring of 2018 in the months the results of the last P3 trial were announced. In that period IMM has a share placing at 144p because there was excited speculation that the results would be successful (they weren't).
We are now in a different situation where Avion have submitted their proposal to the FDA on the structure of the new P3 trial including the Protocal that the only patients that will take part in the trial are those that are bio-marker positive and have been shown to react better to Lupuzor than those that have tested bio-marker negative.
I cannot believe that Avion have made their submission for a Type C meeting with the FDA without being very sure that it will meet with FDA approval. After all, they have discussed this in detail with the FDA in the preceding months.
So we are in a very different place to 2018 when awaiting the results of the P3 trial.

Lambo - your logic is very curious. It would be crazy for IMM to raise funds from a share placing at 5p when if the news is good on 29 August, they could go for a placing at 11p (or more) as they did at their earlier fund raising last December. No sensible person who holds shares wants an undue dilution through an offer of shares at an ultra low price. And IMM is extremely unlikely to wish to do so either.