Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
There is certainly additional value with SDC-1802 being patented up in Autoimmune. Was interesting reading on why Brepocitinib TYK2/JAK1 failed its Lupus registration intent Phase 2 Unlucky for them and a bonus for SDC-180 (SAR20347) / SDC-1802 (SAR20351) https://apps.dtic.mil/sti/trecms/pdf/AD1087498.pdf
“Gline blamed the failure on high placebo response in the trial, according to a statement. Brepocitinib was tested in adult patients with moderate to severe active systemic lupus erythematosus. Efficacy was measured using a common scale for lupus called the Systemic Lupus Erythematosus Responder Index change of 4 (SRI-4).
We saw some of the highest SRI-4 responder rates ever observed in a lupus study in the active arm of this trial, along with a favorable safety and tolerability profile,” Gline said in the Monday release. “Unfortunately, we also saw the highest placebo response rate observed in any significant SLE study, and as such it was not possible to truly assess the impact of the drug, or to establish sufficient differentiation from other therapies in lupus patients.”
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Reading between the lines and only IMO if not already they are now gunning for a license deal at the end of P1a and packaging up SDC-1801 as a Phase 2 ready asset. I think the P2a is just to show intent moving forwards. Noting the company presentation and of interest they were only £1.2m shy of continuing on the previous trajectory of p1b in Aus interesting to limit the WRAP offer….
2024 Anticipated Milestones
SDC-1801: Clinical development roadmap
Multiple Ascending Dose (MAD) and topline data analysis expected to complete in Q2
Assess options for further financing or SDC-1801 licence in Q3
Potential for phase 2a trial in psoriasis patents or SDC-1801 licence from Q4
+ potential for (timing unknown)
SRA737 Update
Share of $1M milestone payment, identification of US partner, clinical plans ($1 million due within 12 months or on licensee’s funding milestone)
https://sareum.com/wp-content/uploads/2024/03/Sareum-Company-March-2024-for-website.pdf
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Yep a fair point HbD that’s why they raise so much to cover working capital :) If memory serves correctly NG at Sierra was on record quoting a P2 Registration-Intent trial in anogential would come in around @ $10m. Not a large sum at all for some of these small US Bio's.
"SRA737+LDG warrants additional registration-intent clinical development focused on patients with anogenital cancer, an indication for which the second line metastatic setting represents a significant unmet medical need with no approved therapies and very poor life expectancy."
Striking anti-tumor activity was observed in subjects with advanced anogenital cancer (Overall Response Rate (ORR) = 30%; Disease Control Rate (DCR) = 60%), encompassing noteworthy tumor decreases (e.g. -66% tumor decrease; resolution of pleural effusion) and promising durations of treatment (e.g. ~11 months).
Most likely a long shot but Avenzo Theraputics looks a bit interesting experienced Bod, timeline of in licensing fits and looking to IPO this year. Maybe one to watch for further in license deals / combos…..
https://avenzotx.com/news
The SP is a reflection of poor financing nothing more nothing less which is now sorted, all positive RNS’s and forward momentum on both SDC-1801 & SRA737 in the last 12 months have been clouded by RF.
Previously under RF we could have drawn down a further £2.7m + £1.2m Tax credits / totalling £3.9m being enough to fully complete P1a & P1b Inc working capital till Q4 2024.
With the current raise of £2.2m Inc 700k Tax credits and with a deferred portion of salaries that gives us a very comfortable cash runway into 2025 Interestingly we are only £1.7m short on a 24 patient trial in either P1b or P2a Trial - Not a huge shortfall /
IMO SDC-1801 is being packaged up for a partnership / license deal on good P1a results without progressing further and may explain why the switch to naming a P2a trail. As a bonus upcoming news is blinded from the Bod / Markets and brepocitinib P1 data is in the public domain for all to compare.
As always DYOR - Value Play Mk Cap a crazy £7m.
Clear road ahead now Huge Value Play @ £7m Mk Cap, any news will send this flying North, Preliminary Mad results, US 1801 Patent, SRA737 News even an appearance from the shadows, Full SDC-1801 P1a data...
I will 2nd a previous post and mark this as a strong buy....
Robin with the raise + tax credits more chance of a License deal on good P1a data than this failing / feels like the for sale board is up highest bidder most likely not the billions that some talk of but on results any deal should be substantially above the current Mk Cap / value play DYOR
It is what it is LTH 's have been shafted and a real shame on P1b / 2a whatever were calling it, but new money has an opportunity now with good P1a results and with the tax credits they are funded through so we have the potential of a license deal just not in the 100s of millions...
Let’s not forget the Bod is on record stating no one will have conversations until end of P1b feels like a Fire Sale won’t be surprised now at a £2m license deal to an undisclosed private pharma on positive P1a data sometime in Q3…. Cant see P1b happening now
Best guess they are expecting the MAD preliminary data this week which will be released alongside the interim results, If preliminary data is good enough the city will accept a heavily discounted placing if not then its a Fire Sale.... GLA
Currently - is the stand out word and August 25" being the maximum term wouldn't be surprised if more shares are issued or RF sell down previous shares held and we still end up owing a substantial amount come Aug 25"
Roivant ends longshot lupus program after phase 2 fail
Roivant’s CEO Matt Gline always knew the lupus drug brepocitinib was a longshot: “Anybody who is not afraid of a lupus study is an idiot, you shouldn’t trust them,”
With RF not willing to continue further financing for whatever reason they most probably want to recoup as much money as possible regardless of price (a bird in the hand) plus they are still carrying additional £1.3 quid's worth - how many shares is that a few mil ? from previous.