Member Info for HotblackDesiato

Fearg/SOG - I think we can safely say the BoD took advice on the completion of the CTA - they wouldn't let things get this far then choose to submit anything less than a 100% viable CTA.

See Part B.4 here (click on the wee arrow to the left of where it says B.4) - https://eudract.ema.europa.eu/help/Default.htm#eudract/section_b_sponsor_id.htm

"This section should identify the major organisations providing monetary or material support for the conduct of the trial. In many cases this will be the same as the sponsor. Where there are other organisations providing significant funding or material support these should be identified (e.g. where a funding organisation or pharmaceutical company provide support for a non-commercial trial ( including (but not limited to) funding, design, implementation, data analysis and reporting)."

I don't know if the review panel would accept an applicant's proposal if it stated something like, "if we pass P1a then we'll do a raise for P1b", hence why I think the BoD need to show that they can fund the whole trial before it starts. If I'm right, then the only way would be to have a partner primed and ready.

Evening SOG - below is a link to the EU CTA validation rules for a third country i.e. the UK.

https://eudract.ema.europa.eu/docs/userGuides/schematron/CTAThirdCountry.html

See the 10th entry from the top - "B.4 Source(s) of Monetary or Material Support for the clinical trial (repeat as necessary)". I'd say it looks like they have to detail where the funds will come from for the full trial, not just the 1a part.

The BoD must have known they'd be asked where the money was coming from. If they didn't have a license partner lined up, they would surely have needed to announce a fund raise by now.

Hi Silver - what we have witnessed is a knee-jerk reaction by a market that only reads the headline "GSK/Sierra hand back 737". The more informed punter knows 737 has not failed and there are many articles written by ACTUAL ONCOLOGY EXPERTS(!) noting the fantastic results observed in their own trials.

Hopefully we'll get more clarity on what happens next in the coming week or two.

I'd have hoped WIP might have been around to give his thoughts - rather conspicious by his absence!

Dang right, they'd have known how good 737 is in combo - https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/a-phase-1b2-trial-to-assess-sra737-in-combination-with-niraparib/

And from 2019 - In multiple mammary and ovarian cancer lines SRA737 synergized with the PARP1 inhibitors olaparib and niraparib to cause cell death - https://pubmed.ncbi.nlm.nih.gov/30024813/

I'd be astonished if 737 wasn't picked up soon.

In a wildly optimistic effort to convince the naysayers that 737 has greater value now than when Sierra took it over -

Sierra ran two Phase1/2 trials. The definition of a P1/2 trial is given here - https://www.lawinsider.com/dictionary/phase-1-2-clinical-trial
"Phase 1/2 Clinical Trial means, in reference to a clinical trial of a Licensed Product, that such trial combines both a Phase 1 Clinical Trial and a Phase 2 Clinical Trial of such Licensed Product into a single protocol, where the Phase 1 Clinical Trial portion is performed first to (a) establish initial safety, tolerability, pharmacokinetic and pharmacodynamic information for the Licensed Product as a monotherapy or in combination with another agent or (b) determine the maximum tolerable dose of such Licensed Product in subjects, and the Phase 2 Clinical Trial portion is performed second to further evaluate safety and/or efficacy of such Licensed Product as a monotherapy or in combination with another agent in subjects treated with a selected dose."

By this point the trolls will be bored and will have stopped reading but I'll press on.

First trial as a monotherapy & results - https://clinicaltrials.gov/ct2/show/study/NCT02797964?term=SRA-737&draw=1&rank=1

Second trial in combo with Gemcitabine plus Cisplatin or Gemcitabine alone & results - https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-004467-36/results

So what about a valuation then?

The link below outlines how value increases at each phase, "Drugs become exponentially more valuable over time: Drugs aren't really that valuable until around Phase 2. This is why most venture capitalists prefer to fund companies that develop their own drugs rather than just discover new targets or hits and then try to sell them to pharma. In our model, each hit is worth $2.7M and it costs $2.1M to get each hit. A Phase 2 molecule is worth $249M and it costs $74M to get to Phase 2. A Phase 3 molecule is worth $1.1B and it costs $154M to get to that point. Unless you can generate high-quality hits or leads very quickly and cheaply, you're better off taking drugs to the clinic yourselves rather than partnering too early."

https://www.baybridgebio.com/drug_valuation.html

To avoid the inevitable flak from glass-half-full merchants, I'm not saying 737 is now worth $1.1bn but what I am saying is if it can be licensed to another pharma then our share at that stage will be worth far more than when the agreement was entered with Sierra. So why did GSK/Sierra hand it back if it's so valuable? It looks like time ran out and they defaulted on some part of the license agreement.

Regards.

Stoney/SOG - glad to see we will not be interfacing with a barrel any time soon!

Just one question re the agreement, part 15.1 states 'Upon the termination (but not expiration) of this Agreement for any reason:' - assuming an expiration date was set, any idea what the date was? Just wondering if they ran out of time or made a conscious decision not to progress 737.

Hi Stoney,

I'm not a patent expert so will leave you/others to look through the links below:

https://worldwide.espacenet.com/publicationDetails/biblio?FT=D&date=20200219&DB=EPODOC&locale=en_EP&CC=EP&NR=3609884A1&KC=A1&ND=8#

https://worldwide.espacenet.com/publicationDetails/originalDocument?FT=D&date=20201001&DB=EPODOC&locale=en_EP&CC=WO&NR=2020198510A1&KC=A1&ND=4#

https://worldwide.espacenet.com/publicationDetails/originalDocument?FT=D&date=20201119&DB=EPODOC&locale=en_EP&CC=WO&NR=2020232154A2&KC=A2&ND=5#

I did reply to a post yesterday from BenH on the patent issue - "If Sierra keep ownership of the combo patent then they might have us over a barrel to some degree - whoever carries on further development of 737 would have to buy the patent from Sierra/GSK or come to some other deal as 737 works best in combo.

Without knowing all the details of the revised license agreement, we just don't know if the hand back is a good thing or not."

Subsequently, SOG gave his opinion that everything would be handed over.

It'll only be when the BoD make a more complete statement (possibly in the forward look section of the imminent year-end results), that we'll hopefully know where we stand.

Hi Warty - perhaps the imbalance of debate is common to all boards. If an investor repeatedly posts negativity or nit-picks insignificant points then it shouldn't be surprising if they receive flak. Yes, we should discuss key events as and when they happen but you do have to question why some remain invested here if they feel the overall outlook is bleak.

If the BoD were constantly raising funds and spaffing it on non-critical things then that deserves to be called out but when people moan about squeeky chairs or how someone speaks then they may be missing the bigger picture - a bit like complaining about stepping on a sharp rock at the beach whilst never mentioning the ocean view.

Yes, yesterday's announcement was a setback but we need to look at what opportunities it may provide. To think 737 is dead in the water is perhaps shortsighted. GSK/Sierra apparently didn't move quickly enough on 737 therefore the clock ran down and they had to hand it back. That does not mean it's junk.

Does removing GSK from the picture make SAR a better or worse target for a takeover - discuss!

Morning SOG - thanks for the info. I'd have been worried if only 737 & the trial data were returned but Sierra retained that 'combo' patent.

Let's see what today brings.

Aye, Fearg, I'm hoping the license agreement stated if 737 were ever to be handed back then all data and IP rights aquired by Sierra during their tenure would also transfer to the original owner(s).

If the BoD could clarify that aspect with an RNS tomorrow then I think the sp would rebound a bit.

Looks like Edison have now corrected the last close price.

Good question, Ben.

Methods of Treating Cancer Using CHK1 Inhibitors - https://worldwide.espacenet.com/publicationDetails/biblio?II=1&ND=3&adjacent=true&locale=en_EP&FT=D&date=20220721&CC=US&NR=2022226338A1&KC=A1#

If Sierra keep ownership of the combo patent then they might have us over a barrel to some degree - whoever carries on further development of 737 would have to buy the patent from Sierra/GSK or come to some other deal as 737 works best in combo.

Without knowing all the details of the revised license agreement, we just don't know if the hand back is a good thing or not.

Ben - just saw your next post - no worries!

Hi Ben - if it were a complete turkey then the sells would outweigh the buys, no?

Good grief, the forum filter has starred-out the last few letters because of what it spells out.....!

If the LSE algorithm is to be believed then there were circa 323k sold and 507k bought yet the sp stayed quite flat....almost as if it were being controlled.

I'm not a conspi****** but it does seem a bit odd.

I've contacted Edison to see if they could get their website to accurately reflect the sp as it still shows the pre-consolidation price.

The curious thing is in WIP's last post, he said, 'Once we see GSK's plans (note, plural) for SRA737...'

Something's afoot.

Hi Potnak - on one hand it is very disappointing but on the other, the fact that Sierra were able to gather positive data must suggest that 737 is worth progressing.

Just for the record, I don't think WIP knew that 737 was coming back but now that the news is out, maybe he's heard more of the detail surrounding it.

Morning all - if all the 737 results so far have been positive, what made GSK decide it wasn't for them?

If WIP is looking in - any idea what's going on?