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Interestingly we shouldn't be drawing down further on the RF facility during Q1 or until we have results from the P1a /
"The First Deposit, Further Deposits and anticipated tax credits during the remainder of 2023 are expected to be sufficient to enable the Company to complete the Phase 1a part of the SDC-1801 clinical study, and to provide funding through to Q1 2024.
In the event that the Company is unable to draw down the majority of the additional £2.4 million potentially available under the Facility as and when expected, the Company will require alternative funding to complete the Phase 1b clinical developments activities being progressed and to provide working capital."
Anyone doubting the value here take a look at the “pre clinical” asset sale below. A T/O can happen at anytime…..
https://quoteddata.com/2019/05/amgen-takeover-nuevolution-rare-valuation-preclin-immuneinflam-assets/
So many positives that are being clouded by the current share price, SDC 1801 I've got that at 90% dosed with no trial halt, best guess all cohorts completed 4th March and full data In April. SRA737 financially to Sar is pretty much where we left off so a big + and US bios can move fast so many Indications & possibilities Registrational Trials.
Always darkest before the dawn and we must be technically oversold now.
Trial timelines cont.
Trial should play out similar to the picture link below with 6 cohorts in the SAD and 4 cohorts in the MAD gives a clearer idea of where we are at with the dates in previous post.
https://www.researchgate.net/figure/Study-design-with-overlapping-SAD-MAD-cohorts-where-treatment-periods-took-place-in-a_fig1_299547400
The Food Effects (FE) study is usually conducted with 2 cohorts of 8 healthy participants from the SAD study. (Unless they recruited separately) Subjects from FE Cohort receive the study drug under both fasting (in a first period) and fed conditions (in a second period) with a washout period of at least 14 days between dosing of the fasting and the fed periods. The FE Cohort can be dosed in parallel of the SAD Cohort receiving the two higher doses.
Trial timelines:
(6th June) Approaching 8 months since the first subjects in the SAD were dosed.
*** 4th Sep First 3 cohort’s of 6 data reviewed authorising MAD study ***
(4th Sept) Nearly 5 months since the first subjects in the MAD were dosed.
(9th Nov) Nearly 3 Months since the first subjects in the Food Effects were dosed.
Looking at similar size P1 trials we can’t be a million miles off based on the amount of cohorts we have in the MAD study (4 cohorts). The SAD part should be well completed and data analysed some report this with some data via RNS some don’t that’s for the Bod to decide.
I think at the end of the day we all would like to see a decent PR push at the end of P1a something NG was really good at during his time at Sierra. Something similar to Ventyx TYK2 P1 results below would be welcomed.
https://ir.ventyxbio.com/static-files/86f7fa3c-c39a-4cc5-b057-4bca3fd752b7
--------------------------------------
News due soon for the single ascending dose (SAD) part of P1a should be completed now and data finalising, let's see if the bod capitalise on the opportunity and RNS to gain some attention.....
Sareum Holdings plc today announces Positive Topline P1 SAD Study Results for SDC-1801
Https://www.nature.com/articles/s41388-024-02939-z
WEE1 and CHEK1 (CHK1) kinases are critical regulators of the G2/M cell cycle checkpoint and DNA damage response pathways. The WEE1 inhibitor AZD1775 and the CHK1 inhibitor SRA737 are in clinical trials for various cancers, but have not been thoroughly examined in prostate cancer, particularly castration-resistant (CRPC) and neuroendocrine prostate cancers (NEPC). Our data demonstrated elevated WEE1 and CHK1 expressions in CRPC and NEPC cell lines and patient samples. AZD1775 resulted in rapid and potent cell killing with comparable IC50s across different prostate cancer cell lines, while SRA737 displayed time-dependent progressive cell killing with 10- to 20-fold differences in IC50s. Notably, their combination synergistically reduced the viability of all CRPC cell lines and tumor spheroids in a concentration- and time-dependent manner. Importantly, in a transgenic mouse model of NEPC, both agents alone or in combination suppressed tumor growth, improved overall survival, and reduced the incidence of distant metastases, with SRA737 exhibiting remarkable single agent anticancer activity. Mechanistically, SRA737 synergized with AZD1775 by blocking AZD1775-induced feedback activation of CHK1 in prostate cancer cells, resulting in increased mitotic entry and accumulation of DNA damage. In summary, this preclinical study shows that CHK1 inhibitor SRA737 alone and its combination with AZD1775 offer potential effective treatments for CRPC and NEPC
Aren't RF about to get another sh*t ton of shares on the 6th month anniversary of the first deposit 4th Feb ? could be up to 3.4 million + shares if I've read it right and could explain any further drop & weight on the share price /
There’s no guarantee of a license deal or T/O at the end of P1 the Psoriasis P1b data would need to be exceptional, the real concern then starts on funding to run a small trial in an indication to get a license deal on the table as was mentioned in the Q&A of the last Investor meet.
Highlightll Pharmaceutical looking to Partner and P3 global trial now for RA after TLL-018’s head to head data against Tofa bodes well as we already have early data on Tofa vs SAR-20347…
Plus only a few weeks until we get brepocitinib’s top line data on Lupus (SLE) which should de-risk us further with the data SDC-1802 (SAR-20351) pulled in this indication:
https://investor.roivant.com/static-files/d86da666-36ec-4888-8241-e66731df0ab7#page=63
Page 63 - 82
To be fair Sfif's timeline is realistic on previous comments from the bod, and even then there is no guarantee of a licence deal, won't be a comfortable place to be but there options beyond that point covered in the recent IM Q&As
In other news...
https://www.fiercebiotech.com/biotech/ventyx-sees-stock-plummet-70-phase-2-success-not-enough-rescue-tyk2-inhibitors-psoriasis
Someone's dumping a few today RF? quick scan of news feeds not much to report still waiting on some P2 data due soon.. one interesting article though and one to keep an eye on going forwards as below:
"A selective, oral STAT3 inhibitor has potential to replace JAK/TYK2 inhibitors and biologics for multiple inflammatory diseases".
https://www.bloomberg.com/press-releases/2023-10-17/recludix-pharma-presents-preclinical-data-from-its-stat3-inhibitor-program-at-the-international-conference-of-the-inflammation
https://recludixpharma.com/wp-content/uploads/2023/10/Recludix_IRA-Conference_Final10172023.pdf