Member Info for Krone

Apologies, ignore this. Previously confirmed that the CSR was received in Q4 2024.

Do we know if the confidential Phase I CSR (as distinct from the journal paper which JR confirmed has been submitted) and which was originally scheduled for completion in 2024 Q3 has been completed?

The toxicology trial failed not because of issues with SDC-1801, which achieved better than hoped for results in Australia, but with some, as yet to be determined, aspect of the placebo arm of the trial. MTD has yet to been achieved. The current formulation is absolutely doing what’s expected. Reformulation would surely require starting from scratch? C79 - would you be so kind as to share your expert opinion on this.

ATB

SDC-1802 (cancer immunotherapy)

· Translational studies with SDC-1802 have been completed, providing a solid data package to support potential further development.

· The strongest cancer response was seen in cancers with a significant level of unmet medical need including indications affecting relatively small patient populations, which are best suited to targeted development approaches.

· The Company is reviewing how best to progress SDC-1802 into clinical development and notes that partnering may be the preferred route at this stage.

Arguably the clearest message from the IMC meeting on Thursday was that given the completion of the translational study SDC-1802 will be progressed via a partnership. Given that 1802 reportedly has a very similar chemical structure to 1801, a question must be whether the current Pharma interested in 1801 will also want to pick up 1802 given that the clinical work undertaken thus far has to a large extent derisked the target and if so whether they will want to wait for the readout from the delayed toxicology study? Similarly, if a different Pharma is interested will they progress on the basis of the existing trial data alone or will they want to see the toxicology data? The ‘first in class’ potential was reiterated a few times! If a new Pharma picks it up the partnership could presumably progress quickly?

As others have suggested, the change in strategy and decision to pivot from Phase Ib to Phase II Ready with the extended toxicology study is likely to have been at the behest of one of the Pharma with which Sareum has reportedly been in discussions for many years. If this in indeed the case it raises serious questions as to the extent to which all the SDC-1801 eggs are in one basket and the extent to which Sareum is actually in control of its destiny. What’s to stop the said Pharma, which potentially has us over a barrel, from simply walking away when the toxicology study is concluded?

Notwithstanding the terms of any NDA, is the existence of an ‘agreement’ between the Pharma and Sareum to develop SDC-1801 to Phase II Ready a matter which should properly be reported to the market? More importantly perhaps is the question of what is Sareum doing to strengthen its bargaining position whilst at the same time hedging bets in the case that said Pharma walks away? Is the board proactively and energetically courting other Pharma in case the current situation doesn’t come to fruition and if not why not?

The upcoming Results presentation provides an opportunity for clarity….let’s hope for once that there is a bold, unambiguous and forthright statement which doesn’t create more questions and increase speculation. If not now, when?

Orbital is a long way from showing its approach works. The biotech is currently running IND-enabling studies with a view to having OTX-201 ready for clinical development in the first half of next year.

BMS has seen enough promise in the technology to pay $1.5 billion to expand in an area that has been on the radar of its cell therapy team. Lynelle Hoch, who leads BMS’ cross-functional cell therapy business, commented on in vivo technology at a Bernstein event last month. Hoch told analysts that her team has been investing in what it sees as a promising but early-stage modality.

https://www.fiercebiotech.com/biotech/bms-inks-15b-vivo-car-t-buyout-pull-orbital-its-sphere-influence

The BJP website indicates a ‘Submission to first decision’ timescale of 11 days. If indeed the 1801 paper has been submitted to the BJP it seem reasonable for this to be confirmed? We then have 8-9 months to wait for publication!

Thanks Georgehume,

Niraparib, a GSK asset…interesting in light of previous references to Luke Miels and his involvement with Sierra Oncology!

Https://x.com/edison_inv_res/status/1974066294451253311?s=46&t=_cUs6qcowyQbbF4MoPYSCw

Apols if posted previously.

The toxicology study readouts can’t come soon enough!

“ Analysts at Jefferies estimated last month that icotrokinra could bring in peak sales of $7.5 billion in the U.S. across various indications, with another $2.1 billion coming from international sales. Meanwhile, analysts at Spherix were suggesting back in April that the drug could be a “game changer” for psoriasis off the back of “robust phase 3 results and clear differentiation from existing oral therapies.”

https://www.fiercebiotech.com/biotech/jjs-il-23-drug-defeats-reigning-champ-sotyktu-phase-3-psoriasis-trial

13th March 2025

Dr Stephen Parker, Executive Chairman of Sareum, said: "We believe SRA737 remains a valuable asset, and gaining control of the licence puts us in a stronger position to explore potential partnerships or development opportunities. Given the existing clinical data, we remain optimistic about identifying a path forward that maximises SRA737's value."

Interestingly the incoming CEO Luke Miels was involved in the Sierra Oncology deal and will presumably therefore be familiar with SRA737 and Sareum. Tenuous link perhaps but you never know!

paraphrase)

• The PREM14A (Sierra proxy/disclosure filed with the SEC, April 12–13, 2022) records a sequence of contacts between Sierra and GSK in March–April 2022. It documents that on March 7, 2022 Mr. Luke Miels (then GSK Chief Commercial Officer) met with Sierra’s CEO (Dr. Dilly), expressed acquisition interest, and on March 8 delivered an initial non-binding $46/share proposal. Revised proposals of $51/share (Mar 11) and $55/share (Apr 2) were later delivered; the filings record follow-up calls, due diligence access and negotiations about exclusivity. The PREM14A shows Miels acting on behalf of GSK in the commercial/transaction negotiations rather than in a scientific role. 

Good morning Citizen,

Unlike you to drift from the science and delve into speculation mode but much appreciated! Whichever way one looks at this it does seem that we are sitting on a number of targets with massive potential. The question remains as to whether the BoD supported by their advisors can actually concretise the potential. Not much longer to wait….

ATVB

Https://www.fiercebiotech.com/biotech/merck-inks-349m-biobuck-deal-apply-ai-challenging-targets

Https://x.com/sparksinsurrey/status/1970475673606332873?s=46&t=_cUs6qcowyQbbF4MoPYSCw

Dr Parker is clearly looking to capitalize on the apparently massive potential created by the white hot CNS/AI space. The Edison piece below highlights further the opportunity and the fact that SP recently appointed Receptor.AI to look at BBB/CNS potential is extremely exciting! We should hear something in the Final Results about SDC-1803/4/5 i.e. the 'three compounds which demonstrated meaningful BBB penetration with one showing strong levels of free drug in the brain'. In the meantime a tweet from SP highlighting the Sareum interest in the Edison article may be forthcoming.

"Central nervous system (CNS) conditions are among the most significant unmet medical needs globally, with neurological conditions now one of the leading causes of disabilities, and having an impact on over 3.4 billion people worldwide. After decades of limited progress, the CNS field is experiencing a renaissance marked by novel technological advances that are overcoming barriers to effective drug development. Sophisticated blood-brain barrier crossing technologies are finally solving the fundamental delivery challenge, while AI-powered platforms are making unprecedented advances in drug discovery and biomarker identification. Most critically, the development of blood-based biomarkers is enabling early diagnosis and precision patient monitoring, addressing key issues that have historically limited CNS therapeutic success rates."

https://www.edisongroup.com/thematic/the-cns-renaissance-innovations-are-reshaping-neurological-therapies/BM-2199/

JR was clear that the readouts from toxicology study would take an absolute minimum of 6 months. As noted by PCS and SOG the 'initiation' of the study is just that. Given the technical complexities, for the full study to be up and running would take some time so its probably unlikely that we'll hear much before the end of the year. That said, the Final Results due next month provide an opportunity for a robustly positive, bold and unambiguous update.

In the meantime, it is nearly 9 months since SRA737 was handed back and 6 months since Sareum acquired the licence....surely time enough to decide whether it is a dead duck of a golden egg laying goose.

GLA

…The company's lead asset is brepocitinib, a dual selective inhibitor of TYK2 and JAK1. Through dual TYK2/JAK1 inhibition, brepocitinib distinctively suppresses key cytokines linked to autoimmunity—including type I IFN, type II IFN, IL-6, IL-12, and IL-23—with a single, targeted, once-daily oral therapy. Brepocitinib recently generated positive Phase 3 data in dermatomyositis, and an NDA submission is planned for the first half of 2026.

https://www.globenewswire.com/news-release/2025/09/17/3151491/34323/en/Roivant-and-Priovant-Announce-Positive-Phase-3-VALOR-Study-Results-for-Brepocitinib-in-52-Week-Placebo-Controlled-Trial-in-Dermatomyositis-DM.html

Good morning PCS et al,

The absence of a visible marketing/comms strategy has been a bone of contention with Sareum for many many years. We are now apparently either in or fast approaching a pivotal stage and one can only hope and pray that all opportunities to optimise Sareum's exposure are energetically utilised. I am confident that Dr P is on this!

Just to note that in respect of SRA737, it's coming up to 5 months since the comment:

'With full operational control attained, Sareum is now positioned to conduct a comprehensive review of the programme's potential. Strategic options under consideration include re-licensing the asset or advancing it in-house with or without a partner......A decision on the optimal path forward will be made in the context of broader pipeline priorities including the opportunity to enhance shareholder value through partnering or re-licensing.'

GLA