Just to say I’m back in. News expected soon…
“ Lupuzor(TM) Phase 2/3 Adaptive Study
As announced in June 2023, following the receipt of comprehensive guidance from the FDA, in conjunction with our US partner Avion, a Phase 2/3 adaptive clinical trial of P140 (Lupuzor(TM)) in patients with Lupus will commence in H2 2023.
The trial design and protocol is substantially different from previous clinical trials that ImmuPharma has completed and includes maintaining subcutaneous dosing but at much higher concentrations and significant changes to patient inclusion criteria and primary and secondary clinical endpoints.
The detailed protocol and key elements of the clinical trial design will be communicated at a later stage once the details of the trial are available on clinicaltrials.gov (a comprehensive database of privately and publicly funded clinical studies conducted around the world).” |
Well into Q4 now, some news on any newsworthy front would be welcome. |
Former disgruntled holder perhaps? |
12p technical target. |
The imperialist - I guess it might.
But the time to do what exactly? Buy? Sell? Panic? Fire Tim? Pop to the loo?
Answers on a postcard please.
Clue: Nobody has a clue how this (or any other share) will turn out. |
Now might be the time. |
 Yup, it smacks of desperation when the RNS keeps trying to make out there'll be positive newsflow going forward. And that this in turn SHOULD lead to an improved share price. Let's just look at the past sharing agreements shall we? And I quote directly from the RNS:
"The Sharing Agreement is similar in structure to those undertaken by the Company with Lanstead in February 2016, June 2019, March 2020, December 2021 and August 2022 respectively. The first three of these arrangements have completed their settlement periods. The February 2016 agreement yielded a net gain to ImmuPharma of approximately £0.6 million more than originally subscribed by Lanstead. The June 2019 and March 2020 agreements yielded approximately £0.9 million and £1.0 million less than originally subscribed by Lanstead respectively. The fourth arrangement runs to March 2024 and is currently yielding approximately £1.1 million less than the pro rata amount originally subscribed by Lanstead on cumulative settlements to date. The fifth arrangement runs to August 2024 and is currently yielding approximately £0.3 million less than the pro rata amount originally subscribed by Lanstead on cumulative settlements to date."
So that's five agreements in total, one of which yielded a positive result (+ £0.6m approx). Currently the other four - of which two are already complete - have yielded a cumulative LOSS of £3.3m versus the current share price. WHAT A TRIUMPH!
Given the above, how many private investors are likely to beat a path to the Winterflood Retail Access Platform so they can subscribe to the Retail Offer? Answers on a postcard please. Clue: the answer may be a nice round figure. At least it can't be negative. Unlike the Sharing Agreement outcomes to date. |
What a shocker. Last time McCarthy did a Lanstead deal because he was confident the price was going up, it plummeted and shareholders were screwed. Never mind, the lifestyle company continues on for him… |
Final flush before an update? |
Chart still looks primed. I don't think today's RNS is the catalyst for the longer term trend change though. |
Looks like you guys are heading in the right direction. The chart would suggest you'll see 15p-ish in the not too distant. |
My that's a long one !!!
------------------------------------------------
11/08/2023 12:04pm
UK Regulatory (RNS & others)
Immupharma (LSE:IMM)
Intraday Stock Chart
Friday 11 August 2023
Click Here for more Immupharma Charts.
TIDMIMM
RNS Number : 1084J
Immupharma PLC
11 August 2023
11 August 2023
ImmuPharma PLC
("ImmuPharma" or the "Company")
BOARD STRENGTHENED AHEAD OF NEXT PHASE OF COMPANY PROGRESSION
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, provides notification of changes to its Board of Directors.
It has been a pivotal 2023 for ImmuPharma, specifically within its P140 autoimmune platform.
Most recently in June, the Company announced that, after receiving comprehensive guidance from the Food & Drug Administration ("FDA") on the new Phase 2/3 adaptive clinical trial protocol for the lead programme for the treatment of patients with systemic lupus erythematosus ("SLE/Lupus"), it is moving forward with the study, together with its US partner Avion.
Positive progress on the P140 platform was also announced in May for a second high medical need disease, chronic idiopathic demyelinating polyneuropathy ("CIDP"). The Company received positive feedback from the FDA at a pre-IND meeting for a late-stage Phase 2/3 adaptive clinical program in patients, which is a further debilitating auto-immune condition within the Company's P140 platform.
In parallel with advancements in the late-stage clinical developments, the Company is also actively in discussions with a number of potential licensing partners for programmes across the Company's development portfolio.
In order to align with the new phase of progress, the Company recognised the need to add further skills and experience to the Board to ensure that we have the requisite Board composition for the next stage of evolution of the business.
We are therefore delighted to announce today the appointment of Dr Laurence Reilly as Senior independent Non-Executive Director and Chair of the Audit Committee. Dr Reilly brings extensive experience in managing late-stage clinical programs through to approval, in addition to commercial and business development experience.
He is currently Vice President of Research & Investments, working with Royalty Pharma, a New York based life science investment company focussing on acquisition of biopharmaceutical royalties and funding of innovation across the biopharmaceutical industry.
Through his consulting practice (Acumen Life Science Investment Consulting) Dr Reilly has provided strategic consulting and due-diligence services to biotech companies, life science venture capital and private equity clients. He also served as Chief Medical Officer for Cellectar Biosciences, New Jersey, a late-stage oncology biotech company. Prior to founding his consulting practice , Dr Reilly served as Chief Scientific Officer and Vice President at Avillion, a drug development company focused on the co-development and financing of drug candidates, where he was responsible for clinical and strategic oversight of co-development programs and partnering with both large pharma and biotech, including Pfizer, Merck KGaA and AstraZeneca. Dr Reilly previously served as a Clinician - Clinical Development & Medical Oversight at Pfizer and at Lundbeck as Medical & Scientific Advisor.
Dr Reilly earned his medical degree from the University of Liverpool Medical School, U.K., and practiced as Neurosurgery Resident at Queen Elizabeth University Hospital in Birmingham. Dr Reilly also holds a Masters Degree in Law from De Montfort University, U.K.
We are also extremely pleased to welcome Dr Sébastien Goudreau to the Board.
Dr Goudreau joined ImmuPharma in 2014 as research director and established the research laboratories of Ureka Pharma (now ImmuPharma Biotech, the Company's French subsidiary) in Bordeaux, being promoted in 2021 to Chief Executive Officer of ImmuPharma Biotech. Notably, working directly with Dr Tim Franklin (ImmuPharma COO), Dr Goudreau and his team are credited for the development of, among others, the Company's anti-infective programmes, BioAMB and BioCin.
Dr Goudreau has also been a key contributor to the progression of the P140 autoimmune platform including the PK study, successfully concluded in 2022, and supported the new protocol design of the Phase 2/3 adaptive clinical studies for both Lupus and CIDP.
Dr Goudreau obtained his PhD in Chemistry at the Université of Montréal as a NSERC fellow before moving to Switzerland to conduct postdoctoral studies at the ETH Zürich as an FRQNT fellow.
At this time, Dr Sanjeev Pandya, has informed the Board that he wishes to step down from his Non-Executive Director position, in order to pursue a number of other external opportunities.
All Board changes take place with immediate effect.
Commenting on the Board changes, Tim McCarthy, Chief Executive Officer said:
"I am delighted to welcome Laurence to the Board. His deep centred experience of late-stage drug development, together with his international business development expertise, will perfectly complement with and support the executive management team and together will ensure that we have the essential skills and knowledge required for the next stage of ImmuPharma's evolution.
I am also extremely pleased to welcome Sébastien to the Board. Having now worked closely with Sébastien over the last 2 years and seen first-hand how he has added invaluable insight and clinical direction within our drug portfolio, his appointment will be an extremely positive addition to the Board.
We are now on a pivotal course for ImmuPharma. As a Board, we remain focused on bringing our two key late stage P140 clinical assets in Lupus and CIDP through their final clinical trials and to the market.
We also continue to concentrate on further commercial and partnering opportunities and with these new Board appointments believe this may be accelerated over the next period. " |
IMM back in play? |
Yes it would be worth trading IMM about 6 months before the results are due but this is a barge pole stock at present. Unless they can pull another rabbit out of the hat, this is going nowhere. Yes there is the other indication but their reputation for non delivery goes before them…. |
Problem is Nobby we just don't know if all three would fail or pass, its an element of luck (on a 1 shot), which is why Supers comment is so practical - there are so many variables as you obviously know. Supers last bit says it all.
I guess on Covid there is now massive info on effects - good and bad, unfortunately the bad only really comes out with real world use, just as it did with Thalidomide (Abstract from link below is interesting in this context). On news - there should be more this year on test and if the test starts some bits in 2024 on progress and maybe the final result, which is why its a good trade unless those in the market have other intentions?
You accept there is a chance the trial will be successful so I guess you agree there is reason to be positive and see trading the churn as a realistic policy!
The problem for IMM is that its a small guy (even with Avion), a big Pharma with P140 would have had more clout with Regulators and if the 1st trial had been done by a big Pharma I suggest things would be quite different on progress. Maybe IMM should have done a deal with a big Pharma, unless of course there is something in the agreement with CNRS to stop that.
Over and out but it seems this is one to watch - corporate action or share price trading opportunities?
From Supers
"and even then one would have to ask was it the increased dosing, or the narrower selection of patients, or something else entirely...?" |
We won’t find out for at least 3 years so that isn’t the reason it’s going down now. More probable it’s just there won’t be any news for a while now |
2.55p on the bid now. collapsing
does the market actually know? |
so whats the market chances off this coming off?
THAT is how its being priced right now
the markets saying it could be a negative |
It wasn’t even close to significance so it would have failed 3 out of 3! For the record I think it has a chance this time but of course it depends on what dosing regime they have chosen as it needs to be much higher… |
markets starting to price up a negative
will drop another 70%if it is |
Question is guys - if the 1st P3 had been carried out three times would the result be:
- 3 fail, or 1 pass, or 2 pass, or 3 pass? Maybe the issue highlighted here is that the testing regime the industry uses is: - lucky to pass and the stuff isn't much good (or worse), or unlucky to fail and the stuff works.
IMO the useful action from the original P3 would be to start a use on market, could even be a Covid like emergency use, to get a so called real world result. After all it seems the stuff has, at the dosage level used, no or very little negative effect. Industry was very keen to get a real world Covid result! So regulators seem to have some interesting approval for market use!
The risk reward currently for the P3 test seems a good bet which is why trading until result would seem a good policy.
Supper's comment is perhaps the most practical on:
"First you aren't yet proven right - it will take a successful trial to be able to say that, and even then one would have to ask was it the increased dosing, or the narrower selection of patients, or something else entirely...? |
Yes. By "worked", he meant it didn't kill anyone! |
Plus the statement in an interview after the failed phase III that the drug ‘worked’ was unforgivable! McCarthy has a lot to answer for…. |
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