Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
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.
Lukehear: You state that the Type C meeting with the FDA has been requested by Avion.
But according to today's RNS, which states that " Avion has submitted, via a Type C Meeting, the positive results from the Lupuzor/P140 PK Study to the FDA".
Therefore, it seems that the Type C Meeting with the FDA has taken place and approval/guidance in now awaited from them as to whether the Avion design for the Phase 3 Lupuzor can go ahead with or without modifications.
Is there a time limit on when FDA must reply?
,
Thanks Lambo. I missed the reference to a type C meeting with the FDA in today's RNS.
Explanations are needed.
I have read the latest RNS with disappointment. It looks more or less the same as the wording of the RNS dated 4 May. It also announced "with delight" that Avion has was seeking final guidance from the FDA on the design of the Lupuzor P3 trial. In fact, the two RNS are so similar it could be a cut and paste job.
Can someone tell me if I have got this wrong?
Nolupus. The article you highlight does not make me wonder at all. What makes you wonder?
Pokerchips: I think many shareholders in IMM have the same question. We were incredulous that the IMM Board was handing over its much needed cash to Incanthera. The link being TM who was chairman of both companies. And what became of Sol, Incanthera's wonder suncream touted as protective against skin cancer? TM promised a big marketing deal with a major company a year or two ago. Since then, silence apart from the squeaky noise of hot air escaping a balloon.
If anyone deserves the sack, he does.
Are you sure it's a buy?
dallo: Very pertinent points you have made in your post. I think Avion will pull out all the stops to get the architecture of the Lupuzor P3 trial approved by FDA and to bring it to a successful conclusion.
Many months ago we were informed that Avion had signed up some of the leading figures in the Lupus research community in the US and had close connections with the most important Lupus patient groups there. So the groundwork has been done to ensure a successful trial.
I am expecting an announcement soon about the start of a trial of P140 (ie Lupuzor) for treating CIDP. Perhaps Avion will be involved in this as far as the US is concerned, just as in the case of Lupus.
It would be daft to exit IMM anytime soon when there are so many good indications for its future.