Member Info for The_Bit_Before

Around a year ago, a very well liked and highly respected private investor in Valirx sadly died. He had committed substantial amounts of money in confidence that the quality of the science underpinning the Valirx portfolio of assets was both credible and held huge potential.
Much ink has been spilled discussing the business acumen of former leadership within this company and the reflection of their successes in the share price. I am not going to rehearse any of that or speculate as to the impact of their actions upon LTHs.
I am of the firm belief that this share should be suspended with investigations undertaken on several fronts. I have to confess my disappointment that, notwithstanding a change in corporate leadership, we have once again witnessed an arrangement of financing at bucket shop prices and followed by a profiteering manipulation of the share price.
The current delay in processing data from the completed VAL201 trial is a disgrace. That data has a material bearing on the SP and should be processed and published. It would not be unreasonable for a timetable for doing so to be released by RNS.
The decision not to notify the market regarding bids made by several entities (as mentioned by some individuals on social media) is wrong and a failure by the BoD and nomad. The fact that Japanese interest was only confirmed in response to pressure from shareholders and after the bucket-shop placing was already arranged, was also wrong and a failure by the BoD and nomad.
I have been in and around Valirx since c2011 and am not a trader. I know several other individuals who hold significant and expensive volumes of shares and have done so with integrity for many years. It is very wrong for anyone on here to cast aspersions about long term holders in the manner that is sadly all too common and has been witnessed even today.

Borgie asked the question. It's a good one. Interest in an AIM company should always be driven by doing your own research. You have to ask which Japanese pharma have an interest in Oncology and, more specifically, in hormone driven cancers (which is what 201 (from which 301 targets a secondary indication in endometriosis). You measure that by looking at their current pipeline. So here are some starting points: Chugai, Takeda, Daiichi Sankyo and Astellas

Takeda have Relugolix currently at ph3 with both prostate and endometriosis indications. Also Niraparib currently at ph2, both for prostate cancer.
Their clinical trials search facility online is very easy to navigate and shows lots of activity in these two Oncology indications
https://www.takedaclinicaltrials.com/

Daiichi Sankyo are very busy in Oncology. They describe it as a "Primary Focus Area"
Their pipeline is full of assets in trials with Oncology indications - http://org.daiichisankyo.com/rd/pipeline/pdf/20200430_Pipeline_EN.pdf
http://org.daiichisankyo.com/rd/our_approach/vision/index.html

Astellas have a partnership with Pfizer where they have licensed an androgen receptor inhibitor (sound familiar) for castration resistant prostate cancer - it's called xtandi.
Astellas are quite busy in Oncology
https://www.astellas.com/us/innovation/areas-of-interest

Chugai (part owned by Roche (global top-10)) - have a big focus in Oncology and currently have a drug candidate in ph1 trials for endometriosis. Of course, their parent company, Roche, have a huge Oncology interest which is bolstered by Genentech.
https://www.chugai-pharm.co.jp/english/ir/reports_downloads/pipeline.html

I'm not making any statements or drawing any conclusions.
I've not posted on here in a long time.
I am in excess of 90% down on my investments in Valirx.
I have been in and around Valirx since around 2011 and my interest is primarily the science.
Do your own research.

Those of you who have been in and around Valirx for a number of years will perhaps know the name, John Gilchrist. It is with sadness that I inform you that he died in late April this year.

John was scrupulous in his research, investigation, assessment and engagement with the BoD. Amidst the often vacuous and self-centred noise on this board and others, he was conspicuous for speaking openly, honestly and yet with integrity and dignity. He would never stoop to name calling and slander.

He put his money where his mouth was and held a significant stake here. I am unsure as to whether he ever exited. As did many of us who discovered the fantastic pre-clinical science behind VAL201 almost 10 years ago, John believed in what remains a fantastic oncology pipeline. Nonetheless, he shared the dismay that many of us have felt at the way that commercial management has not matched the level of scientific competence.

Out of respect, I urge you to receive this news as it is and not do John's memory the indignity of using this merely as a platform to sound off about Valirx. That wasn't John's style and it would be a poor way to mark his untimely death.

PI101? Yes, I remember that name. Did you get in to trouble with admin and get your profile deleted?

This week, I've been working on a project in pre-clinical drug discovery and external innovation for a global top-10 pharma. There's a huge appetite for innovation in many therapeutic areas, oncology included. The big BMS-Celgene deal announced at the start of January will hopefully be the starting bell for a surge in M&A activity this year. Where a company has good assets in the pipeline, market sentiment on the likes of AIM is quite irrelevant.

One of the biggest problems faced by Valirx is the simple fact that the British biotech market is quite immature in contrast to the US. If you look at the numbers of deals completed, this stands up. But in terms of the quality of the science, I regularly hear senior level voices across big pharma acknowledging the quality of science in Britain. I'm quite sure that if Valirx were in the US, it would have been bought out a long time ago. Could 2019 be the year that M&A kicks off in the British biotech space? I sure hope so.

By the way, you questioned my being genuine as a long term holder. My history on this site is there for anyone to review. I first put money in to Valirx back in 2010-11. I've currently got several different holdings in here, having used accounts in the names of my wife and children as well as my own. I've managed to make a small profit on some, but across the board, like most other LTH, I'm a good way down on what I've put in. "swinging from the rafters in anger"? I don't see that it's going to help me. I'm better off keeping a close eye on the science and then taking every opportunity I have to mention the Valirx pipeline to those in meaningful positions in global pharma - which I do.

I haven't logged in here for a long time. Thank you for your post, gisehecube, as it reminded me why I've kept away.

You have a record of just 30 posts here on the LSE boards and yet you feel you have the longevity and credibility to make pronouncements beginning with "lest we forget"? Forget what? You weren't here.

Like many other LTHs in Valirx, I undertook research based on the pre-clinical science - yes, that does date my plug in here back to c2010 - and have always sought to encourage others to interrogate the science in order to understand the value of the assets. I maintain that the Valirx pipeline comprises several very interesting and potentially high value assets.

I'm not naive and I understand that any asset is ultimately only worth as much as the value assigned by the market in which it is sold. But notwithstanding moans and complaints about how Valirx has been managed over the years, it is quite fair to say that this company has been and continues to be willfully targeted by a good many individuals who are concerned only with making a profit by hammering the share price downwards.

Personally, though I'm sure there are a good many other genuine private investors both LTH and newbies who would share this sentiment, I'd politely invite you to take your negativity elsewhere. Of course, if you've got some helpful insights to share at a scientific level, pointers to key players in the oncology markets, comparisons with other biopharma working on breakthrough oncology, etc, please do share.

If our BoD enter in to negotiations of any sort, whether a licencing or sale of an asset or assets, it is a significant weakening of their position if they can be seen to be dependent on such a deal in order to proceed. As a listed business, the financial position is in the public domain and any suitor will do their due diligence and take this in to account.

I do not wish for our BoD to be forced to accept a poor quality deal for less than market value. As a shareholder, I want the BoD to be equipped in every aspect to hold firm and negotiate the very best deal so as to maximise the value of my shareholding. I assume that other posting here will feel likewise. On that basis, before posting any further vitriol decrying the BoD wanting to have a cash-strong position at this time, please consider context and strategy. And if you don't have the commercial understanding and/or experience to be able to do this, hold off your keyboard and listen and learn from those who do.

Which "other companies" are you referring to? I fear that you're making a comparison between experience you might have with oil&gas companies on AIM where, you're right, the likes of a Sound Energy, have regular "fireside chat" events as well as an award winning website.

That kind of cross-sector comparison simply doesn't work. If you're wanting to invest in a biotech, you have to understand the context in which biotech companies work, the regulatory framework that constrains them, the industry-wide timescales through which drug development processes work, etc. Of course, surely it goes without saying that you should at least have a basic understanding of the science upon which the pipeline is based.

There's a wealth of information in the public domain for any investor or potential investor in Valirx who wishes to understand the above. I assume, given your enthusiasm to comment on here, flipsome, that you've undertaken some very thorough research including:

- the outstanding pre-clinical results that were obtained
- oncology drug development processes
- peer-comparisons (you'll have a ready list of other pharma and biotech working on products in the same therapeutic areas)
- financing for drug development and commercial deals with examples drawn from deals concluded in biopharma within the last 3-5 years

Might I respectfully suggest that, if you can't answer in the affirmative regarding the above, you should be really careful about the tone and extent of your comments, if only for fear of coming across as a commentator lacking in credbility and substance.

I headhunt for big pharma at a senior leadership level. From a very recent conversation, I can tell you that the Chief Scientific Officer at a UK-based, privately held biotech with only two products (one in pre-clinical, one in phase 1b) is on £150k base plus package. That base salary is largely reflective of that type and level of role.

Please, everyone, be very careful about making judgements based on your at-a-glance opinion. Ultimately, as with all things, the market decides the value of business leaders and that's no different amongst the talent pool in which the BoD of Valirx sit.

So far as I'm aware, there's nothing that Align Research know that anyone else doesn't know. Let's be clear, they make a living out of putting themselves about as an outfit that's in the know. It's not in their interests to clarify:

who they met with
how long a conversation they had
the headings/primary foci of the conversation
etc

Instead, so long as people on this and other boards continue to perpetuate the unsubstantiated belief that there's 'insider' knowledge that Align have managed to tap into, everyone can continue arguing, ramp and de-ramp as much as they like, ignore their personal responsibility to do their own research for their own investments and the boys in the City will play everyone for a profit.

The BoD have been consistent in divulging very little in what is arguably a wise approach given the very time and cash intensive processes of drug development. Why does anyone here think that because Align Research made a very unprofessional attempt to gain attention, the BoD would suddenly shift on that?

VAL401 and 201 have far greater potential value than Imfinzi due to a much bigger and broader target patient population. If I've understood correctly, Imfinzi has a relatively small patient population to serve: "One clinical trial focuses on patients who do not have either an EGFR or an ALK gene mutation and therefore cannot receive treatments targeted for patients with those gene mutations." "As understanding of the pathobiology of NSCLC has improved, small molecules that target genetic mutations known to play a critical role in its progression have been developed. Epidermal growth factor receptor (EGFR) is a protein on the surface of cells which normally helps the cells grow and divide. Some NSCLC cells have too much EGFR, making them grow faster. The estimated proportion of EGFR mutations in NSCLC in England and Wales is 16.6%. About 5% of NSCLCs have a rearrangement in a gene called anaplastic lymphoma kinase (ALK). This rearrangement produces an abnormal ALK protein that causes the cells to grow and spread. Mutations in EGFR and ALK are mutually exclusive in patients with NSCLC. Their presence influences patient responses to targeted therapy. The majority of people with NSCLC do not have these mutations, and have EGFR or ALK wild type NSCLC." http://www.io.nihr.ac.uk/wp-content/uploads/migrated_new/14916-Durvalumab-monotherapy-for-NSCLC.pdf

ValJu - I don't do medical recruitment. You're right, that'd be manic. I headhunt senior international and global leaders for pharmaceutical and life sciences companies. By no stretch do I feel I have an "intricate" knowledge of Valirx. But I feel that I have enough research behind my investment here to be confident that I'll see a return. And that's the point - I've done my research. Don't invest in a biotech if you've not done your research. If people don't understand the timescales and processes and regulations around drug discovery and development, they're going to do something stupid like expecting that it'll mirror the timescales and processes and regulations around O&G... and then, in unresearched confusion and unwarranted disappointment, they'll get very upset and start sounding stupid on an online discussion forum. You're absolutely right that the share price is being held. The boys in the city have been happy to take money from unresearched and naive private investors in Valirx for a number of years. Granted, it could be argued that fund raising decisions along the way have played in to that. But look at the biotech and pharma sectors more broadly and you'll find many instances of the same. For example, Mallinckrodt (who do have some problems in their business) have been shorted to well below any reasonably reflection of fair value. Analysts keep claiming that EPS is going to be poor ahead of each quarterly announcement and then they show the market that they've outperformed the predictions of those naysayers. Elsewhere, AbbVie and AstraZeneca are still struggling to restore their share price against the games of the boys in the city who are exploiting some bad news stories from recent clinical trials. The bottom line is, in order for there to be helpful and balanced discussion on this and other forums, we need well-researched and substantiated comment. Please post links to sources and then we can better understand each other. And if there's stuff that you don't understand or are worried about, why not get in touch with the BoD? It's not as if they're hiding - their contact details are in the public domain. Better still, get yourself to Edinburgh on 30 May and speak with Dr Morris face to face. https://www.sharesmagazine.co.uk/events/event/shares-investor-evening-edinburgh-310518

Phase 3? What kind of news are you looking for? There's plenty in the public domain regarding the plans that Dr Dilly has for both funding and executing the progression of VAL401 to phase 3 trials. I wouldn't say that there's news that's overdue, though there is some expectation that we might have further analysis of the data that was obtained in the phase 2b trial.

Adam - a point of correction... Only VAL401 is a reformulation - based on Risperidone. Even so, the reformulation is patented by ValiSeek All other assets in the Valirx portfolio are wholly owned and patented accordingly. Whilst you're correct in saying that there is some benefit in a reformulation - this was realised in the regulators granting a bye for VAL401 to go straight to a phase 2b trial based on the safety and tolerability data from Risperidone - it can be a big put off to big pharma who tend to prefer original formulations.

Pharmaceutical companies have vast teams of people who work in 'external innovation', 'business development & licensing' and other similar and related teams. It is the remit of these people to build and retain relationships with biotech companies across the world so that the very best innovation is identified, its' development is monitored and de-risked opportunities are captured. Our BoD have been in this industry sufficiently long enough to have extensive contact books. Additionally, there are many publications which carry news and peer reviews of clinical trials - a feeding ground for acquisition hungry pharma companies. There is a big problem amongst those who comment on this board that there is a lack of awareness of how deals in the pharmaceutical sector are done and, seemingly, an unwillingness to learn in preference for a rapid readiness to complain. Jaynet had it exactly right in her comment this morning

cristalball - with respect, again, you're wrong. "big pharma" are quite happy to pay a premium for de-risked assets. In pharma, de-risked equates to an asset having made it to at least phase 3. As demonstrated recently by AbbVie, the cost of failure in a trial is huge - have you seen their share price? Find us some recent (last 12 months) examples of "big pharma" buying oncology assets that are early clinical phase and then come back and share the substantiation of your comments. Personally, I feel it apt for me to humbly bow to the statistical analysis of MIT. They would argue that VAL201 is not "so unlikely to work". I think it likely that either you haven't read through the reports and analysis at the links I posted, or you found that it didn't support your rhetoric. When you've got some strong, credible research that you can share on this board, please do. Until then, I fear that your commentary sounds rather empty.

Cristalball - like a fairground fraud, your comment is based on nothing. What research are you offering to substantiate your comment that "the chances of success are probably low single digits"? I don't want to sound or be confrontational here. That's not at all my intention. But as ever, I do want to ask for good, well-researched and carefully substantiated comment. Can I suggest that the chances of success for VAL201 are actually very good and improving all the time. As per Satu's comments at the Investor Show (listen between 8:10-8:30 on the video) which follow on from information in the public domain regarding the sign off the regulators gave to the scope of the trial, "we have agreement for" lung, breast and ovarian cancers as well as endometriosis. The latest research coming out of MIT states a 13.8% chance of success for any drug development prospect. https://academic.oup.com/biostatistics/advance-article/doi/10.1093/biostatistics/kxx069/4817524 If you factor in that we have no less than five indications (prostate cancer plus the four mentioned above), the chances of success only increase. For the sake of balance, I should note that if the MOA is found not to work, then it doesn't matter what indication you test against - all results would be negative. However, we have already had confirmation, both verbally and with some data drawn from results at below the MAD, that there have been signs of efficacy. All of this to say, I would conjecture (not calculate) that chances of success for VAL201 are looking better than evens. By the way, this is the kind of document that you need to be reading as a starting point before posting comments about clinical trial success rates on here: https://labiotech.eu/clinical-trials-success-rate/

On that question, I'd urge you to contact Dr Morris and he'll explain to you

a direct answer: I haven't interviewed our BoD, so I don't know. I headhunt in the pharmaceutical and life sciences sectors. My research is something of a bi-product of what I do for a day job as I always take advantage of conversations with global leaders in oncology drug development to glean all I can. I know that there are so many facets to the drug development process that are out of the hands of the executives of biotech companies. The regulators set the boundaries and requirements. If you want to get a product to market, you have no choice but to play by the rules of the game. When our BoD got an extension to their discussions about the 201 trial, I missed out on an opportunity for an 8-bagger in an O&G company I'd planned to jump in to once there'd be a lift on the announcement of the 201 trial. The memory of that stings as it'd have been worth a lot of money to me. However, the BoD were absolutely right to work with the MHRA and, consequently, they obtained a pass on a phase 1 trial and got an accelerated pass to the phase 1b/2a trial that we currently have. That was very good. If not for that, we wouldn't be as advanced as we now are in the development of 201. Are there factors that concern me or that I'd choose to be different? Yes. But I don't see that voicing those hear is a positive for my investment.

ValJu - I think you've just explained yourself. This isn't the O&G sector. We don't have drilling schedules. We have a very highly regulated, IP sensitive, clinically fragile drug development process that is entirely different to sucking products out of the ground. Can you name for us a single O&G executive who is in charge of or even on the board of a biotech? I think the answer to that is worth reflecting on before you attempt any further comparative analysis.

ValJu - with respect, all I'm hearing from you on here is a lot of moaning and complaining. What I'm not hearing is any contribution at all from your research and understanding of the science that underpins your investment. If you've suffered the deaths of friends and relatives through cancer as you've mentioned, surely you appreciate even just a little of the complexity of oncology medicine? Ultimately, please reflect on whether or not your complaints are going to support the share price improvement that you long for or hinder it. And if you've researched and understood the portfolio of the business and appreciated the value of it, what good reason do you have for not giving at least an equal voice to that?