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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.
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.
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
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?
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
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.
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
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.
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.
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
Flash
So a Chairman and CEO of a listed public company issued a declaration via a RNS supported by the Board of Directors and sanctioned by the Nomad that no funds are required and there are other routes to non dilution funding should Immupharma require such funds in the future.
Either Mc Carthy is an absolute charlatan who has acted in a cynical and criminal fashion to deliberately deceive investors or he has acted in accordance with fiduciary responsibilities.
If a placing was announced at 1p in a couple of weeks he would be ruined as would the rest of the Board.
By the way the 2p warrants of £2m are on the threshold of being exercised.
Bought again today
Now about to go through 2p and £2m warrants exercise price.
A long way from liquidation and a further death spiral funding from Lanstead.
I wonder is there anything substantive driving this rally.
A lot of buying going on.
Cauldstream
I think the risk reward ratio is very good at sub 2p for the many reasons already discussed and these factors plus losses forward for tax purposes of c £50m after allowing for R&D credits makes Immupharma an interesting proposition as M&A activity is finally hotting up in the International Pharma sector.
Doff
I have been investing in the Stock Markets for nearly 50 years and nothing surprises me anymore.
However Puretech come close as , despite excellent news, the share price never reacts the way you think
It should .
The share price is not much higher than it was in 2015 despite the major progress made in a number of its wholly-owned drug portfolio, the enormous amount
of cash generated from its founded entity ,Karuna including a further cash bonanza of $325m on completion of the BMS takeover plus $400m due from Royalty Pharma plus further royalties , milestone payments and sub Licensing fees.
Add in its own cash of c$300m, Vedanta, Seaport , Gallop etc etc and no wonder investors are mystified by the SP.
None of the major shareholders are selling otherwise we would get a TR-1 Form and the free float is miniscule after the recent $50m buyback.
No wonder I am befuddled and confused.