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Celtic, I'm on Potnak thinking that once the pk data is released we might well get an offer.
In regards to 1802 we have been toldnin the investor meets pres. that it has had good acute tox studies done already and will be going straight into patients as opposed to healthy volunteers like 1801.
So a takeover could be on the cards if the ph1a data is good as 1802 has the same chemical makeup at 1801.
Just realised Potnak Sareum already have the funds to complete ph1b-
As per the finance RNS-
The Company intends to use the Facility, if fully drawn, together with the receipt of anticipated tax credits to the amount of £1.6 million, to complete the Phase 1a/b clinical development of the Company's lead candidate SDC-1801, which is expected to be a primary catalyst for driving shareholder value, and for general working capital to Q4 2024.
So it looks like Sar can go for the mega bucks deal afterall if we show good efficacy in ph1b. Which leads us nicely on the reasoning behind the finance as some have suggested to stop a potential low ball offer or takeover.
Many happy returns chaps- here to an excellent ph1a pk data we are afterall doing the multi-ascending trial earlier than expected with the safety committee giving the green light after just 3 cohorts out of the intended 6 benchmarked.
DeAar, did you not read the ph1a trial post-
Each participant will be in the study for approximately 9 weeks (Screening Visit to Follow-up Visit) and will receive 2 doses of SDC-1801.
So that is mid to late Nov 2023 for a RNS, we also have the final results, AGM and anything else leading up to the end of the year when Ph1a will be complete.
So puts your no news to bed a little doesn't it you t..t.
Can't seem to find it, but did find this one where he mentions Dr Mike Owen bought into focus on Tyk2's at 6mins.
https://m.youtube.com/watch?v=N0bWyjpTv-c&pp=ygUvVGltIG1pdGNoZWxsIHNhcmV1bSBob2xkaW5ncyBwcm9hY3RpdmUgaW52ZXN0b3I%3D
Hot, Sareum posted this in the 2018 finals RNS, so have an idea already of how much they want the Sotyktu and Nimbus Takeda will only have added fuel to the fire so to speak-
Sareum believes SDC-1801 represents a strong candidate entering an area of increasing industry interest with substantial clinical validation. The Company's view has been formed based on the progress of molecules in clinical development by Bristol-Myers Squibb (BMS-986165; TYK2 inhibitor) and Pfizer (PF-06700841; TYK2/JAK1 inhibitor) in psoriasis and other autoimmune diseases, which has been promising but also shown signals that suggest there is an opportunity for a molecule with best-in-class properties.
Furthermore, several licensing deals for preclinical and clinical-stage assets have been completed recently in the sector with highly attractive economic terms, such as:
· TD-1473 (a pan-JAK inhibitor) - licensed by Janssen from Theravance (2018) at the end of Phase 1 studies for $100M cash up-front, up to $900M in milestone payments, plus royalties*
· Filgotinib (JAK1 inhibitor) - licensed by Gilead from Galapagos (2015) at the end of Phase 2 trials for $300M cash and $425M equity investment up-front, up to $1,350M in milestone payments, plus 20%+ royalties*
· Undisclosed TYK2 inhibitor (plus other assets) - Celgene formed an alliance with Nimbus Therapeutics (2017) in preclinical stage for undisclosed up-front and milestone payments
Approved products targeting the JAK family with blockbuster sales potential, despite warnings based on side effects related to JAK2/JAK3 activity, include:
· Xeljanz® tofacitinib (Pfizer) (JAK1/JAK3 inhibitor) - approved for rheumatoid and psoriatic arthritis and ulcerative colitis, with 2017 sales of $1.35Bn*, despite black box warnings for serious infections and lymphoma
· Olumiant® baricitinib (Eli Lilly) (JAK1/JAK2 inhibitor) - approved from rheumatoid arthritis, with expected peak sales of approximately $1Bn*, but with black box warnings for serious infections, lymphoma and thrombosis
· Jakafi® ruxolitinib (Incyte/Novartis) - approved for myelofibrosis and polycythemia vera (a type of blood cancer) with 2017 sales of $1.1Bn* despite warnings of infections and blood cell counts
The scale of the deals and sales delivered/forecast for these candidates and products targeting TYK2 and related JAK family members gives Sareum confidence in the exciting, high value market opportunity for SDC-1801.
*Sources include company information and analyst consensus as reported in BioWorld "FDA approves Lilly and Incyte's baricitinib for second-line RA treatment" 4 June 2018
I agree that would be what the licencee will want.
So that's where Dr Mike Owen comes in, he knows value better than most and will likely be pitching for as big a deal as possible esp. after the Sotyktu FDA approval and the Takeda Nimbus deal.
We need fantastic ph1a results and the pk data and safety needs to be aced for a mega mega deal then they can piggy back off the Nimbus and Sotyktu and close up shop.
I sense that may well be the case. However, something tells me that Sar might want to get though ph1b if safety is still good to increase the overall value of the licencing deal and inturn see 1802's value increase as well. Ofcourse funding would be needed to complete ph1b.
Is it reasonable to assume we should get an update in late November vai RNS-
Each participant will be in the study for approximately 9 weeks (Screening Visit to Follow-up Visit) and will receive 2 doses of SDC-1801.
I think this puts the adverse effects concern you had Damion to bed-
The SDC-1801 dose to be administered will be decided by the Safety Review Committee (SRC) based upon the SDC-1801 pharmacokinetic (PK) and safety profiles observed in Part 1 of the study. The dose that is selected for Part 3 of the study will have been demonstrated to be well tolerated, and the exposure at that dose would not have exceeded that seen at the no-observed-adverse-effect-level (NOAEL) (in the most sensitive toxicology species, the dog) in Part 1 of the study.
We still have some money to potentially clawback as well-
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 in Australia, 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.
Wait I have the answer-
THEPUMA
Posts: 532
Price: 80.00
No Opinion
RE: RNS. Director buys.5 Sep 2023 10:06
Ahfam
I reckon 50p in 1-2 months, 30p in 2-3 months, 20p in 3-4 months.
But it’s not an exact science.
So right about the time of the ph1a trial results.
Ermmmm T.AT 🙃