Member Info for Faxandtheinfinit

ABBVIE only have a market cap of $258 billion so let’s hope they got the minerals to buy Sareums Molecules?? Lock stock gla

Well anyway growing excitement would be the evidence of institutional investment of a grand scale this has got to be somewhere close to the bottom should be time to load up??? Maybe hopefully time will tell GLA X

I like it

Dr Tim Mitchell, CEO of Sareum, commented:

"We close this financial year with growing excitement around the potential for our portfolio of differentiated TYK2/JAK1 inhibitors.

"Our lead programme, SDC-1801, is a TYK2/JAK1 inhibitor which we believe has significant potential for superior efficacy in autoimmune disease compared to oral therapies currently available and in development. We have submitted a Clinical Trial Authorisation (CTA) application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) and, subject to the required approval, hope to begin clinical trials in healthy volunteers before the end of 2022, with a psoriasis trial planned for 2023. This comes against a background of increased recognition around the potential for the TYK2/JAK1 class, and we have been encouraged by the recent FDA approval of BMS's Sotyktu, the first approved TYK2 therapeutic, and the interest building around the space."

"Our expertise in kinase inhibition, alongside momentum in our translational work, also supports confidence in SDC-1802, our immunotherapy programme targeting cancer. We are working to further define an appropriate patient population for clinical work and look forward to continued progress with this and our other programmes.

"We are pleased to have clarity on SRA737 and to be able to plan the next steps for SRA 737 together with CPF. We continue to believe that SRA737 has great potential for the treatment of cancer, particularly in combination settings."

The places are taken get ready for next RNS lol x

Frankenstein….it’s alive

CTA application to MHRA and Corporate Update

Thu, 28th Jul 2022 07:00

RNS Number : 9953T
Sareum Holdings PLC
28 July 2022

Sareum Holdings PLC

("Sareum" or the "Company")

Sareum submits Clinical Trial Authorisation application to UK MHRA for development of TYK2/JAK1 inhibitor SDC-1801 and provides an Operational Update

á Clinical Trial Authorisation application for a Phase 1a/b clinical trial with SDC-1801 submitted to the UK Medicines and Healthcare Products Regulatory Agency

á Sareum has made significant progress advancing SDC-1801 towards clinical development and plans to initiate Phase 1 clinical trials in 2022, with a study in psoriasis targeted for 2023

á The Company continues to progress translational studies to support its cancer immunotherapy candidate, SDC-1802

á New EU patent granted (April 2022), protecting the SDC-1802 molecule and pharmaceutical preparations as a therapeutic to treat T-cell acute lymphoblastic leukaemia

á Sareum had a cash position of approximately £4.3 million as at 30 June 2022

á A presentation to investors will take place on 4 August 2022 at 10.00am via the Investor Meet Company platform. See below for registration details.



Cambridge, UK, 28 July 2022 Ð Sareum Holdings plc (AIM: SAR), the specialist drug development company, today announces that it has submitted an application for a Clinical Trial Authorisation ("CTA") to the UK Medicines and Healthcare Products Regulatory Agency ("MHRA") for the development of SDC-1801 as a potential new therapeutic for a range of autoimmune diseases with a focus on psoriasis.

Sareum also provides a broader update on operational activities and pipeline progress.

Hopefully by the AGM that historically has been in December the trials and investment or licence will be well underway with the share price reflecting the value of such monumental achievements..
l personally don’t want there to be an AGM as HOPEFULLY all this will be passed on to a bigger pharmaceutical company for the right price of course ASAP so the products that Tim and John have created can reach there potential faster then we. And of course reinvest my money in the local hairdressers as the Raging bull style ride of AIM is no good for my ticker GLA.. come on sar!

IMHO the RNS 737 update was designed to spook the market and private investors whom hold a lot of SAR stock. It was the last ditch attempt to lower the share price. Question??? was that 76000 share trade a sell that dropped it initially?? Everyone knows 1801 is going to clinic and SAR need investment. This drop was designed to benefit institutional investors, a licence or a buyout???? Everything from here is uphill obviously 737 was returned but as a phase 2 complete drug .. trials stated in SARS pipeline chart.. Anyway BUYOUT, LICENCE OR INVESTMENT inbound only positive news from here. I’m an investor so only going to be positive

IMHO the RNS 737 update was designed to spook the market and private investors whom hold a lot of SAR stock. It was the last ditch attempt to lower the share price. Question??? was that 76000 share trade a sell that dropped it initially?? Everyone knows 1801 is going to clinic and SAR need investment. This drop was designed to benefit institutional investors, a licence or a buyout???? Everything from here is uphill obviously 737 was returned but as a phase 2 complete drug .. trials stated in SARS pipeline chart.. Anyway BUYOUT, LICENCE OR INVESTMENT inbound only positive news from here. I’m an investor so only going to be positive

I posted last about 1801 had moved into the clinical section of the pipeline chart. Dividing line between pre and clinical has gone so not clear on progress probably want to keep price down as PIs not in favour???

Another observation that obviously occurs on other stocks I hold is there are no RNSs referring to holdings in the company weather poss or neg?? Obviously the odd one with accumulating value would be seen as a positive? What the blue blazes has PEEL HUNT been up to??? clarity surely is needed now

Positive news on 1801 CTA and funding in the coming days/weeks will lighten the confusion of yesterdays RNS. Or Is there grounds to call an EGM because it’s all become a little misty to me.

Snippet from 28 July RNS

TYK2/JAK1 inhibition has demonstrated benefits in maintaining a healthy immune system and has strong clinical validation in psoriasis and psoriatic arthritis. Psoriasis is an autoimmune dermatological condition affecting more than 60 million adults worldwide, with a market size for potential treatments worth more than US$30 billion. Sareum believes that TYK2/JAK1 inhibition offers potential for increased efficacy in psoriasis, compared with existing approved therapies.

Gunner… bidding war springs to mind… bring it on gla

Yep

Just looked on sareums website pipeline … Proprietary programmes chart tells of 1801 has entered clinical stage.. gla

Well it must be a Mount Everest size price of news?????

RNS from GSK last year was 27th Oct 2021 12:00 pm RNS 3rd Quarter Results… Hopefully the long awaited update for progressing our 737 will headline?? Not long now gla

The BOD already know the outcome of the application, how long to RNS

Assessment of your submission

The initial combined review assessment will be completed within 30 days of being submitted. Applications for healthy volunteer trials and sponsor-determined phase I trials in non-oncology patients may qualify for a shortened assessment time and MHRA will work with the research ethics committee to endeavour to expedite these applications. You should state on your covering letter if you think your trial is eligible. Note that trial designs that stretch to investigating the benefit of the treatment to participants may not be eligible for the expedited assessment timeframe.

We will tell you the outcome of your submission along with the outcome of the research ethics committee review, via the combined review process, which could be:

acceptance of the request for a clinical trial authorisation
acceptance of the request for a clinical trial authorisation subject to conditions
grounds for non-acceptance of the request for a clinical trial authorisation
If we raise grounds for non-acceptance you will have the opportunity to respond, usually within 14 days; however this may be extended on request.

Communication informing the applicant of the MHRA and ethics committee decision following receipt of the responses will usually be sent within 60 days of us receiving the original valid application. If an extension to the response date has been agreed this will impact the final decision timeline.

Hopefully the share price will wake up also!!???