Member Info for HotblackDesiato

Hi CJH - see link below re JNJ-2113 (also known as PN-235). Trials carried out in US/Canada/Europe.

https://beta.clinicaltrials.gov/search?intr=PN-235

Maybe more interesting for us though are the details of the on-license & milestones -

From 27/11/23: https://www.biospace.com/article/releases/protagonist-announces-two-new-phase-3-iconic-studies-in-psoriasis-evaluating-jnj-2113-in-head-to-head-comparisons-with-deucravacitinib/

and from 28/7/21: https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-amendment-of-agreement-with-janssen-biotech-for-the-continued-development-and-commercialization-of-il-23-antagonists-301343621.html

Just in case there're other studies currently on the go, I searched the ANZCTR website for all psoriasis trials registered or started this year in Oz - just 3 results: the SAD/MAD, food effects and Adults with Plaque Psoriasis trials run by SAR.

Onwards!

Just going off piste for a moment - if RF can't lose, why is their own sp a disaster?

Didn't Tim once put a price of £800m each for 1801/2?

Hi Potnak - the potential value would depend on two factors. Firstly, how does 1801 compare to Sotyktu in psoriasis? Our JAK1 side of things may work in our favour and prove to give better results compared to pure TYK2 - time will tell.

Secondly, what other ailments could be treated with Sotyktu or 1801? We know that 1801 can potentially treat Psoriasis, RA, Iupus, IBD, MS and acute respiratory symptoms of viral infections, including Covid 19 so IF it could be proven that 1801 works against those then the sky's the limit. However! That would be a long way off so assuming good results from P1 in psoriasis I'm guessing £500m+ for 1801 IF all goes well and there is strong evidence of potential efficacy in other indications.

The difficulty is answering your question on the probability of 1801 doing well in P2 if it has done well in P1. The target sample size for the P1b is just 12 participants. This is a tiny number but remember the P1 trial is mainly just to get safety data. The P2 study would require maybe 70-100 patients and so this ups the ante quite a bit. Place your bets now.

For the nerds - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3504941/

I think Nimbus are also due another $2bn in milestones in addition to the $4bn so not a bad payday for someone.

IF 1801 does well in P1 and 1802 is a similar compound, add in something (eventually!?) for 737 and I'm happy to sell up for £20 a share. Disclaimer: I'm a blithering idiot so what do I know?

Hi Silver - the Takeda deal was to aquire the subsidiary company Nimbus Lakshmi Inc. and like you, I couldn't find anything regarding a share price. It looks like they might be financed via private equity rather than through public offerings hence no share price as such.

Hi Silver - 1801 is TYK2/JAK1 so it differs from deucravacitinib as that's just TYK2. SOG has often posted on the differences and it's possible our approach may be more beneficial thanks to the JAK1 element.

Evening Laz - the food effects trial could be completed just prior to the AGM. The first dosing was announced on the 9th Nov and the final follow-up visit is 29 days later. If all 16 participants started dosing that same week then we could see a pre-AGM RNS to say the safety committee now have all the data required to make a decision on whether the trial can proceed or not.

If there had been any nasty adverse events then the food effects trial wouldn't have been given the go-ahead. This suggests the safety committee just have to decide on the dose to be given to psoriasis patients and whether or not 1801 should be taken with food or on an empty stomach.

The Nucleus Network aren't advertising yet for psoriasis patients so I'm not sure if they'll wait until the New Year or if they can pre-empt things and get people on the register prior to the final safety review.

Surely once the final stage of this trial starts then the sp should recover despite RF's sales. (Wishful thinking but once we get into the serious end of the trial I'd expect to see new investors taking a punt on us.)

Very interesting, C79.

I imagine the BoD are already aware of the Nimbus trials and tribulations via the biotech grapevine.

Evening GlenF - Although it's pretty much ancient history now, you could either post an InvestorMeets question or corner JR directly if you're at the AGM next month to state you felt misled by the BoDs comments.

The current sp is a shytshow and hindsight is a wonderful thing but without knowing all that's gone on at SAR HQ, I don't see much point in playing the "if only they'd..." game that others seem to enjoy as that just seems to be the other side of the "if only I'd sold at 9p" coin.

Regards.

Hi GlenF - not sure why Spondulicks reposted my original post without any comment of their own but anyway, I vaguely recall something about getting full AGILE funding/fast tracking was reliant on a candidate drug having at least P1 data which 1801 didn't obviously have at the time.

Although the current 1801 trial is aimed at psoriasis we shouldn't forget 1801 may prove to be effective against respiratory symptoms of viral infections, including Covid 19. Reading the news report below suggests there may be a pressing need for urgent treatments in the first nation to grant us a patent.

https://www.bbc.co.uk/news/world-asia-china-67505218

Even if the Chinese patent office probably only exists to keep other nations happy (and I wouldn't be too surprised if some agency there is able to see live data from the trial in Oz), I wonder if a Chinese pharma might try to pick up 1801 before Phase 1 is complete to fast track its development for respiratory infections.

Hi Leggster - I don't think the ethics committee will have any bearing on our trial now. Our next hurdle is for the safety review panel to look at all the data from the SAD/MAD and food stages once they're complete. Assuming we get the all clear at that point, the safety panel will determine what dose we can give to psoriasis patients.

Whatever data the BoD have access to at that stage will maybe allow them to compare 1801 with competing compounds - though only up to a point. However the dosage allowed for psoriasis patients will be a good indication of what's to come.

The latest entry in the link below shows we've now paid the first annual fee so only a few days perhaps until it's fully granted.

https://worldwide.espacenet.com/publicationDetails/inpadoc?CC=JP&NR=2022514799A&KC=A&FT=D&ND=3&date=20220215&DB=EPODOC&locale=en_EP#

Hi Leggster - my own thinking is we won't get a 1801-specific RNS until after the food effects part of the study. Only once all safety data from the SAD/MAD/Food studies is signed off do we get to move on to psoriasis patients.

We may see some other update prior to the AGM which might include a general '1801 is progressing well' statement but at least this food study is relatively quick - now that the screening is complete and dosing has started, the 16 people are on the study for just under a month so it may well finish before Christmas.

According to the link below, it appears that our very own Mike Owen sits on the Scientific Advisory Board of the CRT Pioneer Fund LP.

https://biography.omicsonline.org/france/blink-biomedical/mike-owen-174464

No idea when that webpage was last updated but even if he is no longer linked with CRT PF, at least he might still have contacts and may know the current state of play re 737.

If we don't get an update before the meeting in December, perhaps one of the attendees could corner him (off the record) to pump him vigorously for info.

Hi SOG - just by chance I was reading about the Consilium meeting when your post popped up.

"PANEL 2: Are we nearly there yet?

Private financing has dominated the sector recently and although public markets are showing signs of life, caution remains the watchword.

Our panel talks about how to play the current financing outlook."

Although the BoD said they're committed to the next installments from RF, they've not announced when the money will transfer. Maybe a Monday morning RNS is in the pipeline.

I see we're off to Consilium's Annual Healthcare Conference and also the Jefferies London Healthcare Conference next week.

https://sareum.com/events/

https://consilium-comms.com/news-insights/11th-annual-healthcare-conference/

https://www.jefferies.com/IdeasAndPerspectives/Conferences/325/111621

Morning SOG - so do you envisage RF holding onto the next batch of issued shares rather than selling them? If so, the sp might recover a bit.

I don't recall any large sells appearing this week (assuming previous ones were mostly down to RF).

I wonder if RF have either now sold all those initial shares via the market or have found someone to directly buy whatever they had on left. If they did find a bulk buyer, I doubt we'd find out.

With the 3mth anniversary of the initial funding now past and the BoD saying they've committed to the next two £300k drawdowns, I presume we'll see an RNS next week unless someone (or something!) has stepped into the frame to save us from the sp doldrums.