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When there is a progress to price disconnect, an example of what can happen.
Tempest Therapeutics
A clinical-stage oncology company, announces a partnership with Roche today.
SP went from 23 cents to $9.27 in one trading session. A rise of 3000% in one day.
From their 8K...
"Unfortunately, Tempest, like many other biotechnology companies, continues to experience a significant and ongoing dislocation in the trading price of its common stock" and so on...
Proof that these things can happen in bio industry.
From that fierce article-
“There’s been such a consistent pick up in momentum in anything above a billion [dollars]," Cody Powers, principal at ZS, said in an interview. "I think we’re back on the gravy train of where we were a couple of years ago in terms of premiums."
Billions are a standard nowadays- I did say a while ago that the Takeda Nimbus 4bn deal set the benchmark for Tyk2 deals going forward so not at all sirprised by Dr Mitchell showcasing BMS figs.
Patience indeed Belhus-
https://www.fiercepharma.com/pharma/patient-cliffs-divestitures-and-biotechs-maturing-its-prime-time-ma-analysts
"During second quarter earnings calls, many heavy-hitters—including Johnson & Johnson, Bristol Myers Squibb and Merck—expressed urgency in their quest for deals. With so many buyers in competition, sellers are finding offers that are more attractive".
Someone tell magy t.at that we have a new Chinese patent and US auto-immune patent for 1802 which cross overs and cover 1801 this year.
Master-stroke in my opinion- you didn't think they applied for them for no reason. And China seems to be the target market as Aus is the feeder apparently.
Ph1b is efficacy- it pretty much concludes that sdc-1801 is safe and can be used as a treatment. So beyond this the majors can takeover and licence to commercialisation at a relatively good price.
If we do a ph2 then the price goes up exponentially for a licencee but also a large cost to us to initiate it. So it is in the best interests of both parties to licence up after ph1b.
Also it could well be that a potential licencee has already asked for ph1b to be completed before any serious negotations.
In my opinion it is likely the BOD have decided ph1b to be sufficient enough for a licence as per the agm meet where Dr Reader said at 57:13 ph1b will be gamechanging as we will be able to compare against Pfizer and pre-clinically we have shown good safety.
Posting on a bb is relatively easy as not a lot time is needed to do it, it's not as if you have to sit there and concentrate on what is being said in a live meet. I have posted whilst in a on-line teams meet at work so doesn't take a whole lot of effort. Infact I am posting now whilst on hold to a internal department.
I guess no one will be surprised that I am optomisitic about the future since only in March the FUD was giving us no hope when we were pre-clinical and now less than 4months in we are doing a dual ph1a trial.
Anyhoo, in relation to this-
Of particular importance are the pharmacokinetics findings demonstrating that patients will be able to receive SDC-1801 orally once daily. During this next phase of the study, we expect valuable biomarker data to be generated, that will be available upon completion of this part of the trial.
I would be grateful if anyone could ask if they are seeing any early efficacy in the ph1a insofar.
Thank you in advance.
Ha,sly try to see how it works really-
I think the below paragraph pretty much tells us it works, however, we still have to go through the regulatory hurdles of ph1b, ph2 etc-
Of particular importance are the pharmacokinetics findings demonstrating that patients will be able to receive SDC-1801 orally once daily. During this next phase of the study, we expect valuable biomarker data to be generated, that will be available upon completion of this part of the trial.
Oh and talking of Abbvies Humira, our capsule and early efficacy data. Sareum have already mentioned this so we maybe pleasantly surprised sooner rather than later if we continue on the current trajectory-
"Of particular importance are the pharmacokinetics findings demonstrating that patients will be able to receive SDC-1801 orally once daily. During this next phase of the study, we expect valuable biomarker data to be generated, that will be available upon completion of this part of the trial".
Now you have to ask yourself why would mention patients being able to receive 1801 in capsule form if safety wasn't being aced and they are mentioning pk data already which means they already have grasp of how good 1801 is.
The pk data will determine all the dosage and trial design for all future trials up to commercialisation it is a biggy and what will drive the upward shareprice momentum once we receive some efficacy data in ph1b trial.
Nonsense, I have no agenda unlike you and a few others. People can see posting histories and can make their own minds as to who is what etc.
There is no bad news at all and there is a price to progress disconnect. Just after consolidation we were at over £2 and pre-clinical.
We are now a clinical stage company and doing a dual ph1a trial after just 3 out of 6 cohorts recommended by the safety committee who are in full control of the trial deeming the safety profile of 1801 to be good insofar.
So the question here is we have a once daily capsule in ph1a human clinical trials showing good safety insofar doing a dual trial earlier than expected trying to address an auto-immune illness Sareum describe in todays RNS as follows-
"Psoriasis is an autoimmune dermatological condition affecting more than 125 million adults worldwide, with a market size for potential treatments estimated to be worth US$27.0 billion. Sareum believes that TYK2/JAK1 inhibition offers the potential for increased efficacy in psoriasis, compared with existing approved therapies".
And we are sitting below £2 financing or not that is a massive price to progress disconnect. And remember market leader is Abbvies Humira which intravenous (injection) with loads of issues but pulling in $1bn per month. A big if, but if we show any early efficacy in the ph1a pk data then people can go figure what will happen to the price.
All in my opinion as always.
I've said it before ph1b data can do extraordinary things. This example is more akin to our 1802 as cancer but goes to show how things unfold if data is good-
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
Lets see how things pan out we are still in clinic nothing has failed and 1802 will use 1801 learning as pointed out by the BOD.
Potnak, I understand them saying ph2 will be 2025.
But we have to take into consideration that ph1a was meant to have 6 cohorts before we went on the multi-ascending dose study.
It is not in Sareums hands anymore all they do is report now- So the safety committee which is controlling the trial, timescales and everything else has not only moved the trial early on to a multi-ascending but kept the initial trial so we are now doing a dual trial.
My point is that at the rate we are presently going anything could happen i.e. trial design could change as early efficacy from the biomarker data expected end of year together with the pk data for ph1a could show substantial promise or we could stay as we are to 2025 ph2.
I have seen bio's change ph1b to act like ph2's because of good early efficacy data from ph1a so it is possible.
To add to that- I take note from AGM when we were told the following-
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.
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.
So we have site of what pure Tyk2 has done in clinic if our approach i.e. Tyk2 Jak1 turns out to be superior and the biomarker, pk data are robust we're off to the races so to speak as large pharma is on the hunt for safer and more effiecient treatments.