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Here is my message from earlier today. Ignore flash and his pals. They drove price down with the cash flow issue-RNS-price rise-they sell-now want price down again. Seen it done before. We must ignore them for our financial health and sanity.
Of course they have gone silent. Pushed the price down-loaded up-RNS positive-as expected-price doubles-sell.
Worked in top broking house years ago-switched on sales partner gets an idea-buys-tell other partners -they buy-all tell their clients-they buy-original partner sells.
Ignore the aptly named flash and his pals-it's the same old-same old.
GLA proper investors
" Pushed the price down-loaded up"
well you loaded up too wildbunch and were very pleased to have had the opportunity...so maybe they were not so bad then
What investors should into account in relation to any commercial deals on the RoW rights to Lupuzor, Global rights to CIDP and the anti infective programme is that the Alora Pharma Group has , in effect , made a staggering $25 m "upfront payment" to Immupharma in funding the Phase 3 Lupuzor trial in return for the US rights to Lupuzor and thereby obviating the need for Immupharma to raise this amount in the markets which dare I say would be extremely difficult if not impossible.
So Immupharma's shareholders get a risk free bet on a potential blockbuster drug in return for ceding the US rights to Lupuzor but still retain the royalties, milestone payments and sub licensing fees on the US Lupuzor revenues
How if anyone thinks that in agreeing a Rest of World deal on Lupuzor will not entail substantial upfront payment on a fully funded trial , they are not in the real world.
Also given the Alora Pharma commitment the negotiations on the CIDP commercial deal , where the Phase 2/3 trial on the drug is being conducted in parallel with Lupuzor by Simbec-Orion , the benchmark has been set by Aloras $25m funding.
So there is plenty of scope for successful commercial transactions on all Immupharma's drug products and in relation to the going concern issue for the Auditors the 3 funding options of warrants, commercial deals and the use of the Incanthera financial asset ( as security for a Convertible Loan for example) will be more than reassuring in this regard imo.
Accordingly as a Director and Chartered Accountant myself ,I would be more that happy to sign off on the 12 months going concern statement in respect of Immupharma.
For its worth and given Alora/Avion is funding the trial I would be disappointed if Immupharma didn't secure a minimum of $10m on the RoW Lupuzor rights plus royalties, milestone payments etc.
Imho
DYOR
Finally you must remember that the Alora group has expended enormous amount of management time and expense in dealing with the US FDA on trial protocols and procedures over the past 2 years to get us to this stage as well as investing c£1m in a 80% premium placing at 11p over 2 years ago.
Flash
If McCarthy and the Board of Immupharma have lied and a placing at the levels you are talking about is done I would no longer be a supporter of the company and its management.
I hope that clarifies my position
" They have been trying to do a deal on row rights for years,"
Flash
They have been WORKING on deal RELATIONSHIPS ....and the deals are a PROCESS that takes time and are normally dependent on other events reaching a certain achievement
so..the "deal" relationships have been steadily growing as progress is made ...
so
Pokerchips
You are indeed correct
After exhaustive analysis on dosage , trial protocols patients selection and costings et al, Simbec-Orion were finally appointed on the 19th December 2023.
That to me was a major milestone and then allowed Immupharma management to have bullets in the gun in terms of negotiating with interest parties on RoW Lupuzor rights plus CIDP where Simbec-Orion will be conducting trials in parallel with Lupuzor.
With actual trials commencing the game is totally different from an negotiating standpoint.
Immupharma now has a strong hand to play with rather than we hope to start trials with Alora/Avion in the undefined future.
That's why now Immupharma is in a much stronger position imho.
At my advanced age and experience in the Stock Markets ( including some right disastrous investments offset by some good ones) I am confident of one matter in relation to Immupharma in that if a commercial deal(s)) on Lupuzor and CIDP plus the anti infective drugs plus the Incanthera revenues soar for it anti cancer suncream , Sol , Immupharma will have a market cap of minimum £50m plus before trial results are announced in 2 years or so.
Assuming the company is not bought out before that.
Remember the £50m tax losses are another tempting attraction as McCarthy alluded to at the AGM.
And all for a market cap of c£8m
I hope I have got it right and hate rampers but if anyone wishes to have a counter argument I would welcome it.
DYOR
ATB to the long termers ...8 years for me .. Doh!
D
Dallo: You are a far more experienced stock market investor than I am. Do you have any insight into why the recently acquired small pharma called Amolyt which has one peptide drug in a Phase 3 trial, has been valued by AZN at $800 million up front plus a further $205 million dependent on achieving sales targets? At the same time IMM, with more peptide drugs on its P140 platform at |Phase 3 stage than Amolyt, is presently valued at £8 million and estimated by you to be worth £50 million. Why the enormous disparity in the value of these two small pharmas? I don't get it.
Cauldstream
Amolyt's endocrine parathyroid drug entered Phase 3 trials in 2023 with top line results expected in 1st Half 2025...2 /3 years after trial initiation.
The world market for hyperthyroidism treatments is c $1.5b.
The market for Lupus is c4 b and CIDP is c $1/2 b
Amolyt Pharma raised over €250m in funding over the past 5 years..the French are different!!!.
So the takeover valued at $1b is based on the belief that the Phase 3 will be successful...some punt by AstraZ.
So why Immupharma is valued at £8m is beyond comprehension imho.
Hyperparatyroidism treatment, I should say
Dallo:
Well, it's beyond my comprehension, too.
You say the French are better at raising finance for their small research pharmas. But IMM has good French links - its labs are in Bordeaux, I believe, and the whole purpose of IMM is to commercialise the research by France's leading scientific organisation into peptides, etc. So why on earth does it not carry the sort of market valuation which Amolyt has?
Cauldstream
My wife has a thyroid condition and she takes calcium tablets.
Hence I cannot see the logic in the Amolyt valuation but there you go.
So much I don't understand in this crazy world.
ATB
Cauldstream
When I said Immupharma should have at least a £50m market cap, I meant after a commercial deal is done in the near term but the valuation should move much higher as the trials progress.
The World Bio Technology markets are coming back to life and the acquisition of Karuna Therapeutics by Bristol Myers for $14b for its Schizophrenia drug KarXT drug awaiting FDA approval in September this year is an example of the prices being paid by the majors as their existing drugs programmes go generic.
By the way KarXT was developed by Puretech, where I have a big investment, and from Puretech is is set to make hundreds of millions of $ even though it offloaded the development risks years by setting up Karuna as a separate entity funded by outside funding and investors.
Sound familiar?
Cauldstream
When I said Immupharma should have at least a £50m market cap, I meant after a commercial deal is done in the near term but the valuation should move much higher as the trials progress.
The World Bio Technology markets are coming back to life and the acquisition of Karuna Therapeutics by Bristol Myers for $14b for its Schizophrenia drug KarXT drug awaiting FDA approval in September this year is an example of the prices being paid by the majors as their existing drugs programmes go generic.
By the way KarXT was developed by Puretech, where I have a big investment, and from which Puretech is is set to make hundreds of millions of $ even though it offloaded the development risks years ago by setting up Karuna as a separate entity funded by outside funding and investors.
Sound familiar?
Flash
You obviously don't know much about medicines and drugs.
For instance there has no new antibiotics developed since 1987, the treatment for Diabetes is still injecting insulin into the body after 50 years , Glaucoma is still treated by eye pressure reducing drops as it was for 60 years etc etc.
Where progress has been made in chemotherapy for instance, is that the sclentists / chemists have developed the ability to mix old drugs together to get better outcomes.
Lupuzor was successful in Lupus patients who were Antibody Positive Lupus sufferers but the trial included all Lupus patients including in Mozambique
where the trial cohort was badly run.
In fact the original Lupuzor trial was badly designed with low dosages and inadequate resources and management.
Following the the exhaustive discussions with the FDA and a total overhaul of dosages and patient selection et al the new trial is a totally different beast.
In relation to my previous post on Karuna's KarXt schizophrenia drug , this is a reconfigured therapy based on previous drugs but now has been modified to allow intravenous doses to be replaced by slow release tablets .
So nothing really new or novel in the world of new drugs but great strides made in adapting and reformulating old drugs in combination with other therapies and being able to get these combo drugs into the human body without causing the immune system to reject them...
That's what Lupuzor does for Lupus patients in its reformulated new dosage and drug transmission protocols agreed with the FDA and the scientists in Alora Pharma and Immupharma France.
Or this is what we hope will lead to a successful Phase 3 trial if all goes well....but there is a risk it will fail.
Cheers
Thanks everyone
dallo- that makes sense, and by taking fda/Scientists advise on board, Tim and team could turn this around.
Gla
GoldGirl - you should be aware they HAVEN’T totally taken the FDA’s advice on board in terms of the new trial protocol.
Going straight to another P3 trial is against the FDA’s recommendation.
The FDA doesn't make recommendations in trial procedures and protocol but gives certain guidance to companies undertaking these trials.
The FDA wanted a dose ranging study done for Lupuzor which was the basis of the original Phase2/3 but after consultation between the parties it was decided to move directly to Phase 3 with a dose ranging process to be integrated into the new Phase 3 hence the delay , in part, in appointing Simbec-Orion as the trial managers.
Dallo, you are right to stress the importance of dose and formulation (BioAmb being a particularly relevant example for us) , though, of course, many of the latest immunotherapies are genuinely novel as is Lupuzor's mode of action. I also agree that there were problems with inclusion criteria, recruitment (very heavy on the Mauritius centre) and clinical end points. For instance, a drug that causes no symptomatic improvement compared tp placebo but which alows the clinician to drastically cut the dose of steroids the patient takes would be a huge step forward but would be classed a failure unless steroid dose was one of the predetermined end points. Let's hope we have learned the lesson from the first phase 3 study, though the positive phase 2 study it was based on was less than striking. I reckon they will have to develop a peptide that significantly prolongs life if I am ever to get my investment back here!
Jonah,
You are quite correct and it was the trial in Mauritius not Mozambique that eyebrows were raised over in the last Phase 3 trial.
The comments by Lord of Lolly are another example of some of the posts here recently saying that Avion and Immupharma went against the recommendation of the FDA in going straight to a Phase 3 Lupuzor trial.
This is totally wrong and deeply damaging to the company. The FDA asked for a dosing testing programme to be included in the trial as a proactive suggestion.
Initially Avion and Immupharma considered doing a short Phase 2 trial on a dosing regime ( over months) and immediately merging into a Phase 3 proper.
However after further review and consultation between all parties, it was considered that a full Phase 3 incorporating a dosage testing regime , the results of which would be released during a number of interim breakpoints in the trial. The FDA is apparently satisfied with this strategy and honestly does any rational person think that Avion is going to risk the wrath of the FDA and lose $25m by telling it to stuff its guidelines and advice particularly after 2 years of intensive discussions with the FDA.
Please contact Tim or Lisa to obtain independent clarification on this and any other matter.
"...but there is a risk it will fail. "
It is all about reducing the probability of failure , and it is evedent many steps have be taken and decisions made, over many months to reduce that probability
Lower probability of failure is obviously teh, a higher probability of success
Avion clearly greatly involved in those decisions and steps, which although is a long process , means it more likely to be worth it....in the end
A further interesting fact on the BMS takeover of Karuna is that BMS completed the deal in the knowledge that there are potential royalties payable to Puretech and Royalty Pharma of over $1billion..yes Royalty Pharma where our Non Executive Director, Laurence O'Toole is a Senior Vice President..
Laurence Reilly I should say
My phone is going bonkers tonight on fast text
Too old for this technical challenge..doh