GreenRoc Accelerates their World Class Project to Production as Early as 2028. Watch the full video here.
Potnak, Val went to Georgia to some cancer trial on pregnant women as could not get anyone insane enough this side of Europe to take on the trial.
We have no hallmarks to Val believe me- just relax and watch the story of Sar 10yrs+ in the making come to fruition.
I see me fud post has been deleted as it highlights what I have said before that bashers only go for good stocks- and we have had our fair share all the way to clinic and it will continue until we licence out 1801.
Then it starts again with 1802 and chk1- unless we get a buy-out- but judging the statements about the $4bn takeda nimbus deal from our bod only a take out of epic proportions will make them sell as we keep getting those patents and hence the patent clock ticks forward- chinese for 1801 and us auto-immune for 1802 as backup to 1801- absolute masterstroke by our genius Dr Reader.
True, but we think we will licence 1801 once we get to ph1b well at least that's the idea.
I think most agree 1802 is the biggie as nearly ph1 ready and no direct competiton in the cancer immuno marketspace and in my opinion I believe we held on to 1801 long enough and it's getting in thre way of 1802.
Potnak, I believe we maybe surprised how quickly we get 1802 into clinic-
Half yearly Inv meet-
https://m.youtube.com/watch?v=KJFhOEmaPFw
12.10- Dr Reader on 1802, it has shown good efficacy in pre-clinical cancer and just need to complete translational studies to define optimal cancer application and then select cancer population and begin ph1 trials.
12.40- 1801 and 1802 derived from same chemical class, so can push forward with 1802 learning from 1801 experience.
26.15- 1802 translation studies are in progress and done some short term acute tox studies already all of which were fine. Manufacture will be in line with 1801 process so no hanging about when they are ready.
27.20- 1802 will begin clinical trials in patients not healthy subjects.
Australia is built on first-in-human on healthy subjects so may not be in Australia.
And will be quiet a different ph1 clinical trial than that envisaged for 1801.
In my opinion- looks as though they have prepd it super primo pronto insofar.
T.at- obnoxious maybe yes to a certain type of poster but stupid no and certainly not a ramper-
It's enthusiam not ramping, maybe over enthusiatic yes- but then I have seen my 30k investment go as low as 9k as high as 300k and everything inbetween even after selling half to meet costs associated with my fathers death I am in healthy profit and Sareum are a totally more validated company then when I invested over 10yrs+ ago- so anyone who has been through a similar path as me would be a tad bit enthusiatic now we are finally in clinic first dosed on 6 June and the safety committee have not pulled the plug.
Let the price yoyo continue, add at these low prices as 1st dosed on 1st June and ph1a is alive and kicking.
Wk8 and overdue news- in my opinion if we get a change of trial design you will not be able to buy under £1.20 minimum as safety will be nailed on as no mtd visible from a distance.
Part 2- this is more akin to 1802 I believe as cancer but goes to show if ph1b efficacy data is semi-outstanding the effects it can have on the price and company-
Forty Seven (‘47’) was founded in 2015.
In October 2019, 47 traded at $6 per share.
Magrolimab was 47’s monoclonal antibody. I.e. A type of protein that is made in the lab and can bind to certain targets in the body, such as antigens on the surface of cancer cells.
There is an urgent need for new, transformative medicines for myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).
47’s investigational therapy targets CD47, a “do not eat me” signal that allows cancer cells to avoid destruction thereby permitting the patient’s own innate immune system to engulf and eradicate those cancer cells.
In December 2019, 47 presented promising results from their Phase 1b study of magrolimab in patients with MDS and AML at the American Society of Hematology meeting.
At the time Magrolimab had been granted Fast Track designation by the FDA for the treatment of MDS and AML.
As of the data cutoff of November 18, 2019, 62 patients had been treated with in the Phase 1b portion of the trial, including 35 patients with MDS and 27 patients with AML.
46 patients were evaluable for response assessment, including 24 patients with untreated higher-risk MDS and 22 patients with untreated AML, who were ineligible for induction chemotherapy.
In higher-risk MDS, the overall response rate (ORR) was 92 percent, with 12 patients (50 percent) achieving a complete response (CR), eight patients (33 percent) achieving a marrow CR and two patients (8 percent) achieving hematologic improvement. Two patients (8 percent) had stable disease.
In untreated AML, the ORR was 64 percent, with nine patients (41 percent) achieving a CR, three patients (14 percent) achieving a CR with complete blood count recovery (CRi) and one patient (5 percent) achieving a morphologic leukemia-free state (MLFS). Seven patients (32 percent) had stable disease and one patient (5 percent) had progressive disease.
The median time to response among MDS and AML patients treated with the combination was 1.9 months.
Median duration of response and median overall survival have not been reached for either MDS or AML patients, with a median follow-up of 6.4 months (range 2.0 to 14.4 months) for MDS and 8.8 months (range 1.9 to 16.9 months) for AML.
I.E. this data demonstrated 47 had gone *part way* to validating an immune invasion response.
This data took 47 from $15 > $40 in 2 weeks.
Gilead paid $95 in Mar 2020, 3.5m after the data was released.
That equated to $4.9Bn.
5 months to move: $6>$95
As always lets get to ph1b gamechanging stage and see how things pan out- Sareum will not take 1801 to market it is not their business model and ph2 is doubtful as well so ph1b for me is as Dr Reader mentions gamechanging.
Many happy returns chaps- let the price y
Dr Reader has mentioned ph1b to be gamechanging so I have tried to understand why the excitement and here is my take from what has been said in the investormeets-
27:10- Are we being out competed as market is increasingly competitive now- Dr Mitchell advising 2 leading Tyk2 are pure Tyk2 which are allosteric. As we are dual Tyk2/Jak1 we could go down both markets and there is space for us and early clinical data will indicate how competitive we are in Psoriasis but also other auto-immune indications. So plenty of space and not concerned about being over competed and leading product give good validation for Tyk2.
https://m.youtube.com/watch?v=1x1_ktQPLik
4.17- Dr Parker again reiterating that the upfront $4bn Takeda Nimbus Tyk2 deal underscores the great potential of this class. (We are Jak1/Tyk2 and Sareum believe we are superior as per RNS).
30:10- Is there clinical validation on Tyk2/Jak1 approach- Dr Mithell advising yes and of Pfizer who did phase 2 in Psoriasis and Psoriatic Arthritis which was very similar to us and they are also looking at Lupus (remember 1802 was tested successfully by the US Army in Lupus)-
1802 has received a US patent for auto-immune this year.
57:13- Absolutely key we get 1801 into clinic, ph1b will be gamechanging as we will be able to compare against Pfizer and pre-clinically we have shown good safety.
1:03- Dr Reader very much gunning for partnering early or late clincial and also advising 1801 could be licenced and used in other indications- he has a suspicion that Jak1/Tyk2 pathway could be used in several different therapeutic areas.
https://m.youtube.com/watch?v=KJFhOEmaPFw
5.55- Dr Mitchell mentioning the Takeda Nimbus $4bn upfront saying 'it very nicely undescores the commercial potential of these types of inhibitors'. (Sar benchmarking what they potentially want I think).
7.55- Dr Reader reader mentioning Tyk2 and viral bacterial pneumonia, then advising Tyk2/Jak1 has the potential to yield superior efficacy against Tyk2 alone. (It's a biggie all respiratory illness, covid etc.)
8.05- Dr Reader- 'We believe Tyk2/Jak1 are optimal targets for auto-immune diseases'.
Also advising Jak2 and Jak3 have lead to unwanted side affects in some patients.
31.35- Moving swiftly on, Dr Parker- 'we do believe that we are very firmly in one of the most exciting periods of the companys history'.
Further Information on the Phase 1a Trial of SDC-1801
The phase 1a trial includes a single ascending dose study (Part 1), a multiple ascending dose study (Part 2) and a food effects study (Part 3). Part 1 will consist of at least 6 sequential, ascending dose cohorts of 8 subjects each (total of 48 subjects) randomised to receive SDC-1801 or matched placebo in a 3:1 ratio. Each subject will be in Part 1 for approximately 6 weeks (screening visit to follow-up visit). Part 2 (multiple ascending dose) is planned to commence after the Safety Review Committee (SRC) has evaluated the available data from at least Cohorts A, B, and C in Part 1.
The multiple ascending dose part of the trial will consist of at least 4 sequential, ascending doses of SDC-1801 or matched placebo cohorts (cohorts A to D). Each cohort in Part 2 will consist of 8 subjects (a total of 32 subjects). Each subject will be in the study for approximately 8 weeks. Part 3 of the study is expected to run in parallel with Part 2, and will examine how food affects the absorption of SDC-1801.
The Company expects to provide a further update on the trial once initial safety and pharmacokinetic data observed in the single ascending dose study provide sufficient support for progression to Part 2 of the study, expected in H2 2023.
So lets see how it pans out shall we- the important thing is it is safe no one has died- so all eyes are on Mr Safety Committee mens- could he change the trial design, seen it happen before because safety was so good mtd was miles away.
Funny you moron, I don't believe I said it wouldn't go under 90p, I said it would be amazing if it did as most would swoop to increase their positions.
In regards to ph1a next cohort delay-
The safety committee are in charge nothing to do with Sar it is out of their hands- they are controlling the trial and would have stopped the trial in week 1 and we are week 8 where as per the RNS the next cohort should have moved on at wk 6.
So either dose escalation is being chosen or trial design is being changed as initial safety has been aced with no sign of mtd- either or is a massive positive.
But I have said it before inflection point for price will be ph1b as by then we will have a set dose going into efficacy studies in Psoriasis hospital patients and will also determine the amount for ph2 and ph3 for whomever on-licences 1801. Until then the price will yoyo as predicted by many. However, ph1a safety data will also have a positive effect as we will be able to compare it against invivo pre-clinical studies and will set the scene for future trials.
So nothing to be concerned about- it is first in-human let the safety committee decide what to do next and then watch to see how we go.
I said ph1b efficacy will be a major price inflection point. But we cannot underestimate the other inflection point for 1801 which is publishing of the ph1a safety data.
At this point we will be able to see exactly the dose and tox level to used for all future trials going to hospitwl patients.
It will the industry, investors and those of us like Sad, RMM etc who understand the science an insight into how we compared against in-vivo studies pre-clinically and first in-human.
It will provide a fascinating indication as to how safe and potentially potent 1801 will be going into clinic with the intention of becoming a best in class once daily capsule to treat Psoriasis.
Many happy returns chaps- remember 1st dosed on 6th June, 6wks for cohort escalation so overdue news.
They also have this money to come in-
Australia offers state-of-the-art research facilities and an efficient approval process, making it an attractive location for research and development. Moreover, the country provides significant tax incentives for companies that conduct their research there, allowing them to claim up to 43.5% of their eligible R&D expenditure as a cash payment. As such, Sareum has established the required local presence by setting up a legal entity in Australia.
No one cares- the price from here leading up to ph1b will be seen as a blip.
Seen your type many times before all the way up to clinic- so lets see how it pans out.
Remember-
- 100% owned once daily capsule
- Tyk2/Jak1 route superior to Allosteric Tyk2 approved for NHS and by FDA
- Ph1a safety at present not stopped by safety committee since first dose 6th June
- 1801 chinese patent with Aus seen as direct route to market
- 1802 new patent US for auto-immune to go with cancer patent making it a backup for 1801 but has had acute tox studies done in cancer and no direct competition cancer immuno market but we brinking ph1.
- Chk1 speaks for itself ph2/ph3 ready lots interest to us and cancer research- form a orderly queue as per investor meet.
I am very confident in us acing ph1a and getting to ph1b for 1801 the rest (1802, chk1) will follow it's natural course- the science is good or we would not get patent approval or be in clinic
Just a massive opportunity to buy more at these ridicously low prices- we are a clinical stage now and if were going to the pits then 1. We funding would have been obtained in the first place and more importantly 2. The safety committee who are controlling the trial would have stopped the trial in week 1 and we are week 8 where as per the RNS the next cohort should have moved on at wk 6.
So either dose escalation is being chosen or trial design is being changed as initial safety has been aced with no sign of mtd- either or is a massive positive.
But I have said it before inflection point for price will be ph1b as by then we will have a set dose going into efficacy studies in Psoriasis patients and will also determine the amount for ph2 and ph3 for whomever on-licences 1801. Until then the price will yoyo as predicted by many.
Potnak, I sort of understand where your going with it and the negative noise from the Fuds don"?'t help. But it was far worse when we had £4m from York/Master back in 2012 and we were pre-clinical then but we survived.
But no way can we be compared to Val- I'm still invested in them and we are no way similar to them from Board to Science- much better position.
Tyk2/Jak1 is the auto-immune future direction for majors since the Sotyktu FDA approval and we have 1802 on the brink of clinic which has had acute tox studies done all well and will go into hospital patient and Chk1 speaks for itself.
Above all the SKIL Platform (the goose that lays the golden eggs) is invaluable at present, consider it churned out chk1, auro, both Tyk2's and has the capacity to do more- what would big pharma pay for it if 1801 gets to Ph1b with high mtd and low to little tox issues and we get some efficacy data showing this. All a big if, but we are in clinic and the bashers gave us no hope of getting here after the MHRA nonsence.
Dr Mitchell has stated on the latest RNS "Our lead candidate SDC-1801 is progressing well in its development". The Majors and the 125m sufferers of Psoriasis want safe treatments and the Tyk2/Jak1 route pre-clinically has shown excellence in this field hence why Sareum were so eager to get to clinic.
https://m.youtube.com/watch?v=1x1_ktQPLik
57:13- Absolutely key we get 1801 into clinic, ph1b will be gamechanging as we will be able to compare against Pfizer and pre-clinically we have shown good safety.
1:03- Dr Reader very much gunning for partnering early or late clincial and also advising 1801 could be licenced and used in other indications- he has a suspicion that Jak1/Tyk2 pathway could be used in several different therapeutic areas.
Once we get some efficacy data in ph1b and it is good the price will be £5+ easily as we will be gunning for Humira which is intravenous (injection) and has load of issues but still pulls in $1bn per month.
No wonder Fudt.attery is in full flow as they want in lower for this once in a lifetime company before we get to Ph1b as then we will be in hospital and patients and it is where in pharma historically you see signs of real fruition- hence Dr Readers "gamechanging" remark.
Additionally as most have pointed out we may never need to take the full money and could return it and we also looked at other avenues of funding- this part of yesterdays RNS indicates as much-
Full safety data from this trial are expected to be available during the first half of 2024 and, provided satisfactory results are obtained and funding is available under the Facility or otherwise, a Phase 1b clinical study is expected to commence as soon as possible thereafter in psoriasis patients.
The Directors have assessed a number of financing options for the Company including an equity raise and believe that the Facility is the best option available to the Company at the present time in order to further fund its progress.
F...g death spiral my a.se
Aye, I posted this from the September 2012 RNS when majy woof was making out we were death spiralling-
Financing
Sareum, the specialist cancer drug discovery business, is pleased to announce that it has entered into a £4 million Standby Equity Distribution Agreement ("SEDA") with YA Global Master SPV Ltd, an investment fund managed by Yorkville Advisors LLC ("Yorkville").
The SEDA is intended to provide a flexible source of future funding to the Company to support its on-going drug research activities as well as reassurance to Sareum's potential commercial partners that it has access to other funds, in addition to any anticipated licence deal income.
We had nothing in the clinic at that time chk1 was very early pre-clinical and we had 1 tyk2 and the rage was about aurora.
Now we are clinical stage chk1 ph2/3 ready and 1801 in ph1a and 1802 almost ph1 ready and they think we are in the proverbial because we've took some money to get to ph1b 🤦
Lesson 1
Bashers never bash bad stocks. You can watch the board for stocks with no potential. You’ll see pretty quickly that those stocks don’t have bashers. Bashers only go after stocks that are going upwards or have excellent potential to go up. Bashers get left behind, so they want to bring the price down.
Lesson 7: Bashers play on your lack of patience. You have held a stock for a while. You knew it will be a big stock someday, but the BASHER CAN GET TO YOU BECAUSE YOU ARE TIRED OF WAITING FOR YOUR GAIN. That's when the Basher is best. You are tired. You have forgotten the goal for the stock was to hold it for one year. The Basher is bothersome, so you dump it on a bad day. Some others also dump. Then you get mad for your loss and return to let everyone know how mad you are. Then you turn into a semi-Basher as well. THE BASHER HAS WON, AND GAINED A NEW ALLY - YOU!
Lesson 8: BRING THE PRICE DOWN. That is the Basher's job. The truth is not important. Lies are the norm. Post continuously on the board every day. They are trying to scare the newbies that are just investigating a stock. They are trying to wear down the faithful longs on the board and gain free reign and control and they will do whatever it takes.
Dr Tim Mitchell, CEO of Sareum, commented:
"Our lead candidate SDC-1801 is progressing well in its development. This agreement with RiverFort provides important support for the trial and general working capital.
"This funding, if fully drawn, alongside anticipated tax credits, allows us to complete plans for the Phase 1b portion of the trial once the Phase 1a part is concluded, and provides cash runway into Q4 2024.
T.AT a funny one at that- toodle pip