Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
As you can all see so much has happened in 12 months or as Tim likes to now say H1 & H2 of 2023
11 Nov 2022 07:31
RNS Number : 1192G
Immupharma PLC
11 November 2022
11 November 2022
ImmuPharma PLC
("ImmuPharma" or the "Company")
Avion confirms its continued support to the Lupuzor™ clinical program in Lupus
whilst exploring broader collaboration opportunities
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is pleased to update the market on a recent meeting in Atlanta, USA with our US partner, Avion Pharmaceuticals, LLC ("Avion") for strategic discussions around ImmuPharma's Lupuzor™ clinical program.
This included Avion continuing its support to the clinical program of Lupuzor™ for Lupus, as well as a wider discussion on how the two companies could potentially further collaborate.
Key highlights:
· Lupuzor™ for Lupus clinical program to be redesigned on key protocols following written response from FDA, in order to enhance the probability of success.
· Potential of product sales revenues for ImmuPharma by introducing certain Avion drugs into the European market.
Lupuzor™ for Lupus
At the recent meeting in Atlanta, Avion confirmed its support for the Lupuzor™ clinical program in Lupus. This follows on from the receipt in September of the written response from the Food and Drug Administration ("FDA") to the Type C meeting.
In its written response, the FDA provided significant and extremely valuable guidance on the study protocol, that could be amended, to improve the regulatory outcome. This primarily focussed on a recommendation to explore higher dosing levels (given the robust safety profile of Lupuzor™) than have been used in the clinical program to date, to enhance the probability of meeting the primary endpoint of statistically significant efficacy. The ImmuPharma/Avion team, together with external advisors, are preparing a proposed updated clinical programme. This is considering either a Phase 2 dose ranging study to identify the optimum dose level, followed by a Phase 3 study with that optimum dose; or alternatively a Phase 2/3 adaptive study which would encompass the same dose ranging, albeit within one continuous study. The chosen route will be agreed with the FDA. Further details on the study design and progress of the program will be communicated to the market once the FDA has been consulted and their response has been provided.
Potential Distribution Agreement
We have agreed to explore the opportunity of a mutually beneficial route to allow ImmuPharma to introduce certain Avion products into the European market. If this is successful, this would generate top-line product sales revenue for the first time in ImmuPharma's history and contribute net positive cash flow to the Company.
We in turn, have identified an established European partner who could provide the infrastruct
Pokerchips,
I believe both Imm and Avion have blatantly lied and deceived all shareholders and H2 was so vague, if they get any slower
Planning and communicating we will be in 2025 as I've said pre iuosly their last proper RNS was June 2022 and we are now Nov 2023 and all we know is the CRO has been chosen no plan communicated.
Lambo222 I would contact Tim until the end of the month as he's still in hibernation and won't awake until he can start to open his advent calender. I wonder what excuses he will come up with for the delay and the lack of comms in H2 which should have been a ery busy time for Immupharma. They have hidden behind the FDA for too long now and should be delivering value to shareholders Tim must go if there is a delay again.
This was my post on the 15 Dec 2022, and we are nearly a month away from the anniversary of it and we are still in the dark over whether Lupazor will ever get to market or even through a trial with Imm involved. If this is what Tim keeps promising about more frequent comms then as shareholders we don't stand a chance of seeing our investments returning any profit.
Don't Tim and Art want to help Lupus sufferers or are they not truly convinced about the drug anymore?
Question are these comments by Tim and Art back in June the most misleading and worst comments they have made this year? If you think yes click on the recommend below.
RNS: RELEASE 27 JUNE 2022
Commenting on the announcement, Tim McCarthy, Chief Executive Officer, said: "This final step by Avion is a pivotal moment for the Company and for the progress of Lupuzor™ towards becoming a groundbreaking new treatment for Lupus patients. Lupuzor's™ unique mechanism of action and robust safety profile will, we believe, position Lupuzor™ as a first line therapy to many Lupus sufferers globally."
Art Deas, Chief Executive Officer of Avion further commented: "Having met all the FDA's requirements, we are delighted to be seeking the FDA's final guidance on moving Lupuzor™ forward into the new international Phase 3 trial. We anticipate Lupuzor™ becoming the leading product in our portfolio and that it will be instrumental in bringing an innovative treatment to Lupus patients, which is not currently available on the market today."
Lambo
You should know by now that Tim either exaggerates on dates or keeps things from us regarding the FDA. We should all know by now that we can only trust Tim as far as we can throw him. He's a wheeler dealer and has never delivered on anything apart from reducing the share price and losing money for long term shareholders, we just have to hope the medicine delivers what the scientists promise.
Tim does not come out of his hibernation until the second or third week of November, so we just need to wait until then as we all know H2 last until the 31st of December so he could wait until just before Xmas thinking he’s given us all a Xmas present with an announcement that it’s started but patients won’t be selected until Q1 of 2024 and trial starting Q2.
Blue apple it should be 100 times more value but Immupharma and Tim McC always over promise and never deIiver. In 2018 we were told by Tim that signing up with Avion was going to push us on over the next 2 years it did not happen, the SP back then was almost 14 times what it is now. In Tim's book long term is 10 years of a large salary and pension pot for him.
He never give informative target dates its H2 rather than Q4 and now his latest promise is I quote "the next period" is that 3, 6, 9 or 12 months or years or decades. Basically he does not know and he does not know how to deliver anything positive.
This must be the weirdest, odd or bizarre acquisition ever by Mr C. I don't know if he was in Vegas going a few parties and while tanked up he offered to buy the company from someone or its all to do with them having licences in the US. Can someone else shed so light?
Robbie I agree with most of what you say but is it a great buying opportunity as the SP has dropped considerably year on year. That is why my 4 year investment is down overall 58% and I feel like a long term hostage rather than a shareholder.
Ocelot, George said the same in last years half year report but the truth is from last year the SP is down over 36% so he's not really looking after shareholders and his progress is extremely slow and worrying. He knows that shareholders are tied in because selling up now would mean large loses for most long term shareholders, I'm down 58% on my long term investment so I cannot just sell up and get out. I wish he could be honest with us for once and not keep over promising and under delivering.
Good RNS update apart from the last sentence of Tim's comment - "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."
When does the "next period" start and finish? Come on Tim read back your comment before you put it out and say to yourself would I be happy with such wishy washy timeline.
And the good news from Tim Mc is he's worth every penny of his salary and he's doing a great job for us shareholders. I would like to live in his world, he's obviously thick skinned and happy with mediocre.
If anyone close to Tim Mc monitors this board can you please ask Tim Mc to pull his finger out and give us an update on planning or when we can expect trials to start. I don't think he fully appreciates how much value on our investments if we are long term shareholders that we have, mine is down 75% and now I'm retired I don't have a work income that I can invest more and reduce my average. He keeps telling us he cares and will communicate more but neither are being evidenced.
Even if once a month the update says we are 50% through our planning phase or we are looking to start in September or October telling us he wants to start as quickly as possible is rubbish, Tim please give us something concrete if you don't my 75% will soon become 80% and depress me even more, I'm not in a position to get out and dont want this to be my children's inheritance i would like it to be my enjoyable retirement.
Wild bunch your rightly mistake but still morethan a couple of years.
I've watched Tim's interview a couple of times now and he does have a very poor memory for important things that interest shareholders.
1st point Tim the agreement with Avion was not a couple of years ago it was November 2018.
2nd point Tim your communications are getting worse because after each one you have to do an interview to clarify your previous communication.
3rd point Tim since being CEO the shareprice has dropped from 8.15 in July 21 to 2.10 now, and you are happy with what you have done. I hope you feel guilty about what has been lost on shareholders hard earned money, we believe in the drugs but not you as keep disappointing some of us.
My take away was Tim said at the beginning of the interview there were questions not answered by the RNS and guess what Tim failed yet again no detail or answers. Why we ask well the answer is Avion hold the purse strings and if they don't start spending the $25m soon it won't happen in H2. If they have to get a team together to run the trial most people in the positions they are looking to fill will have to give 3 months notice so after all the interview process they probably won't start until Sept/Oct at the earliest. Then the planning starts and the picking of patients etc for the trial. It does show a lack of confidence from both Imm and Avion that they were going to getapproval from the FDA. Wildtiger one question I would ask Tim would be for the salary he's being paid has he delivered for shareholders?
Come on Tim and Art you should be in a position now to tell us actual planned start date of the P2/P3 trial. Unless like previously they have just sat around waiting for the FDA feed back before they start planning and agreeing the start date and the number of people required for the trial. Very frustrating yet again with urgency of both Imm and Avion.
Below is a link to a recent Guardian Article
https://www.theguardian.com/world/2023/jun/18/georgians-dream-of-eu-membership-as-their-leaders-move-closer-to-putin
If Zenith are successful then they should pay a special dividend for all holders from yesterday's date.
Wild bunch it is not worth speaking to him he does not respond, as others have said fingers crossed for something just before the Lupuzor C meeting next week. I'm just frustrated like the rest of the shareholders who have been invested over 6 years.