Member Info for Noise

http://www.arianapharma.com/2018/10/ariana-pharma-helps-valiseek-demonstrate-efficacy-of-its-lung-cancer-therapy-in-phase-2-clinical-trial/

I didn't notice Ariana had some Valirx PR up last week. Nothing massively exciting but shows they have been in contact about putting the trial data online.

No, I just believe in checks and balances where appropriate.

He is free to criticise Valirx, but in return his motives and transparency are debtable, considering the obvious rivalry of two companies with anti-NSCLC products.

Hi Chelsea, pleasure to see you again, for transparency, could you remind this board how you are connected to Scancell and their NSCLC trials?

Excuse my cynicism, but with 33k posts, exclusively positive and gushing with praise for Scancell (and their NSCLC drug trials), while also being stingingly negative on Valirx (with their lead drug going in to Phase 3 for NSCLC), it's relatively safe to assume that you are commercially involved with Scancell in some regard.

Considering your track record, perhaps an e-mail to the Scancell directors to confirm who you are would be appropriate.

In general, I would not suggest RNS for a patent publication, it is not entirely appropriate, but could be included in perhaps a quarterly update.

A key patent grant would be an ideal candidate for an RNS, as it would potentially confer a specific item of value that could materially change a company valuation.

Interesting additional piece of news made public in the last fortnight. It appears that Valirx have filed for an Endometriosis patent, which was published on Sep 27th 2018 (note: published does NOT mean granted, it just means it has been made public).

http://www.freepatentsonline.com/20180273585.pdf

Couple of interesting notes here. In animal studies, 3 out of 4 mice did not show any endometriosis growth at all on Val301. In control groups, 4 out of 5 developed endometriosis. Fertility was not affected.

The HE3DA factory has the roof on and sounds like the utilities are being installed. Sounds like serial production is scheduled for late 2019.

https://www.he3da.cz/single-post/2018/09/17/Stavba-nejmodern%C4%9Bj%C5%A1%C3%AD-evropsk%C3%A9-tov%C3%A1rny-na-v%C3%BDrobu-bateri%C3%AD-MES-v-Horn%C3%AD-Such%C3%A9-m%C3%A1-st%C5%99echu-a-prvn%C3%AD-technologie

Translated:

"The construction of the state-of-the-art Magna Energy Storage (MES) factory for the production of backup energy sources according to the Czech patent in Horní Suchá near Havířov has moved to the next stage. The building is fully roofed and technology is starting to be installed. Serial production of HE3DA batteries with an annual production capacity of 1.2 GWh will mean that the factory will be one of the largest suppliers of comparable lithium batteries, at the same time it will be the most environmentally friendly operation of its kind in the world and will be fully robotic.
..
The factory will be one of the most modern of its kind, currently at the top of Europe. Once completed, we will be one of the largest similar investments in Europe. We can start producing serially at the end of next year"

Freddie, taking the existing £10m market cap, I would expect a deal to provide enough funding for a phase 3 with a token £10-30m payment for historic works. I think a £20-30m mcap in 6 months is not unrealistic, assuming the product works.

I suspect 201 will become interesting by next summer, by then any interested partners will have phase 2 trial data and if they want to expand into endo/breast/ovarian etc. But I would suggest patience is key here.

I see no reason why with good trial data £150m in 3 years time would not be unrealistic, but market pressures are what they are, product efficacy is not fully transparent and supply/demand dictates that if you persistently go to market with cheap equity investors will run away until value is undeniable. I suspect some of Val's competitors like to visit this board, because big global pharma's have invested tens of billions on products that in theory are easily surpassed by 201.

From what I could tell, our old pr manager from a tech company basically spent all his dad on Facebook telling people who had issues with our products they were wrong.

Pr/advertisers are useless 98% of the time.

Sshhh now, they have provided PSA level data and scan results in the past, was the last update 18months ago? They must have dosed at least 1.5 patients since then, frankly I nearly had kittens the last time I saw the results.

Do you reckon that new data is available, but perhaps undergoing peer review at UCLH before publication?

"A post period preliminary inspection (announced 06/09/18) of the clinical data derived from the original dosing regimen has been completed regarding all the subjects that have been treated to date. This inspection considered all dosing regimens. In summary, the preliminary observations highlighted a dose-related impact on patients' physiology and chemistry, such as androgen PSA and various cell and protein turnover factors, which are important in the treatment of cancer. These are in line with anticipated outcomes as far as cancer reduction is concerned. Meanwhile, the Company continues to recruit appropriate patients for this second part of the trial"

Hmm. If you wanted to sell some equity all they have to do is post the PSA results etc. It's been some time now since they posted an update on that.

Do we have any consensus yet whether the 8/16mg dosing has been attained? Or is that rumbling on into 2019? That might be enough for a 201 buyout trigger

Nice (highly technical) article to VAL201 and breast cancer from August 2018.

The author is one of the original Italian academics who wrote the patent now owned by Valirx. Only a small mention - but the method of action graphic shows what VAL201 is trying to do (and nicely compares other approaches).

https://www.frontiersin.org/articles/10.3389/fendo.2018.00492/full

Immunotherapy is a sexy in vogue field right now, but it won't work for all cancers, while several types of immunotherapy have a particularly bad success rate.

I note some key breakthroughs going through clinical trials, but I typically read 50-80% success rate.

Ta, any idea what the next timeline is now?

I recall there being early talk of Valiseek going for an IPO around for around this time, hard to say what's happening behind closed doors. I think things will be moving faster by December, as you'd like to think they'ed schedule VAL401 workload to reduce in time for pharm off VAL201.

VAL401 is a small molecule drug (i.e. not a peptide I don't think). It basically interferes with the function of the HSD10 enzyme mitochondrial function, in some cancers the mitochondria get stuck on "cell growth accelerator mode" (about 10x normal function, resulting in uncontrolled tumour growth), VAL401 in theory inhibits HSD10 back to relatively normal function, although depending on the specific genetic fault it may not cure the original fault.

In theory we also know VAL401 is broadly safe in humans and appears to work well in a petri dish and animal models, indicating it will probably be useful in some manner in humans, how useful is the big question.

This is my own laymans understanding and may not be 100% correct.

Couple of points:

22.5m trade earlier - dya reckon that's an early transfer of new equity to a broker, for slow dumping onto the market?

Trying to figure out what this means: "the net proceeds of the placing will be used to extend and expand the scope of the clinical trial of VAL201 to treat prostate cancer".

"extend and expand" - are they rolling out to the long rumoured additional trial site at long, long last? I recall George was talking about moving to the final (16mg?) dosing.

Well, you cannot ask for much more from VAL at the moment. They promised a phase 3 trial for a key HSD10 regulator with 20 years medicines history, they are commercialising that.

They promised us a phase 2 VAL201 trial, we're currently 4 years into that, no adverse affects of note are reported, efficacy has been consistently reported, the latest updates on it show confirmed efficacy on PSA levels and scans (on patients that current medicine has given up on), the latest feedback is "it has performed extremely well", it is "well tolerated and safe, efficacious and works". Full data expected by let's say...January?

Interesting that Valirx are now positioning VAL201 as a potential agent for preventing metastatic growths, I presume this is for hormone-related cancer conditions. I'm not sure how they'll target the testing/commercial elements of that but it's another potential there.

The ASX is a vertiable haven of sensibility compared to the crap of AIM.

Jonjo, frankly, after 5 years investing on the stock market, I would suggest there is a great deal of merit in his argument.

Until we cut off the AIM stockbroker/forward-sold equity racket at the knees, AIM will resemble a casino of poor investment choices in the bottom half of the market.

That said, I'm reasonably positive on Valirx's drugs at the moment.

It's an interesting timeline of events

July - VAL401 comes into commercial discussions
4th July - Dr Dilly attends US bioconference
10th July - Align Research (affiliated with UK investors, Tom Winnifrith sort of crowd) go apecrap and write a 'shareholder revolt 'letter (perhaps trying to stop VAL going stateside?)

Vague rumours they are actually in discussions with partners on VAL401 now. Who knows where this will lead (if, of course, it leads anywhere). The 401 product is either fabulous or duff, I cannot personally tell.