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I'm afraid that declaration of patents isn't "the final check box". It's a necessary step in drug discovery and development. If you don't own the IP, why would you invest any money (wherever that comes from) in further development? If you do a bit of general online searching around patent claims in the pharma sector, you'll find that there are plenty of current cases between companies large and small. If you're on the cusp of a potential blockbuster drug, it matters that you can substantiate your claim on it. And all of that is before you factor in the nuisance of copycat efforts in APAC. The BoD have been entirely right to take time and care to secure IP. In particular, the quality of the US patent grant is quite exceptional and I mean that in the literal sense. For a relatively small biotech to be granted such a strong and full patent is very rare as the US is a notoriously difficult environment in which to get that. Naturally, the stronger the Valirx IP, the greater the potential value of the assets. Yes, it does strengthen the position for negotiating a JV and I'm as hopeful as the next person about an announcement along those lines. But I'm happier about strong IP and no JV announcement soon than weak IP and a JV where we could get stung.
WillyW - the thing is, for the share price to lift, we need well-researched and well-informed investors. Such people will be able to appreciate the value of the portfolio, understand that the current price is a massive under-valuation and seize the opportunity to buy in. It's buying that will lift the price - that's how the market works. I fear that you'll respond by repeating your previous comment and point the finger at the BoD and decry the seeming lack of information flow. However, that would be to ignore the information we already have, both scientific and commercial. Bleating on with moaning and complaints drives potential investors away, so it doesn't help the likes of you and I. For my part, I want to help people to take a careful and well-researched approach to investing in Valirx. I have a part in two stakes in Valirx, one of them over 90% down and the other a mere 35-40% down. But I've done my research and I understand the science and I understand the pharmaceutical industry and I'm confident that at some future point I'm going to make a lot of money here.
"we have agreement for..." - listen to Satu's words from the April Investor Show. You'll find them at 8:10-8:30 in the video. No, this isn't new news. But for our many under-researched contributors on here and potential investors looking in, you'll want to refer back to the original text of the regulators' green light for our current VAL201 phase 1/2 trial. Under the umbrella of "solid tumours" VAL201 has a reach to lung, breast and ovarian cancers and as we know, VAL301 is being set up for endometriosis. When any pharmaceutical business is conducting assessment and evaluation of early clinical phase assets, the potential for drug development of a single asset for multiple indications is a major value generator. How about, instead of another afternoon of moaning and complaining on this board with little if any reference to substantive research, we share informed opinion drawing on the plethora of information and data in the public domain regarding drug valuations in the therapeutic areas that Valirx are exploring? I'm sure that such discussion would be far more useful both for us long term holders and for newer or soon to be investors.
I can't quickly find a document specifically referring to phase 2 trials, but the following link is well worth having a glance through: https://www.abpi.org.uk/media/1627/guidelines_phase1_clinical_trials.pdf Specifically, you might read p37: "The trial findings should be published,35 as an electronic and/or paper document, within a reasonable time after the end of the trial. The sponsor and investigator should agree the publication policy in the protocol or contract, before the start of the trial. The sponsor must be allowed enough time to obtain any patent protection. Either party may prepare a manuscript for publication in a peer-reviewed journal. Each party should allow the other at least 30 days to comment before any results are submitted for publication. Authorship should reflect work done by both parties, in accordance with recognised principles of scientific collaboration. " This isn't oil and gas. Private investors who complain that "other" AIM companies provide more results data are almost certainly not referring to biotech companies. The regulatory framework around drug development and launch, including clinical trials, is necessarily rigorous and robust. Notice the reference in the above to "the end of the trial". There are also protections for the patients on the trial to guard confidentiality but also to guard against any placebo effect that might be brought about by a patient being able to identify their results during the trial. Such an event might be deemed to compromise the integrity of the trial data. It's reasonable for us to be asking questions of each other and helping fellow investors as we share from our research and volunteer opinion based on good information. However, it's totally unreasonable and frankly unhelpful and financially dangerous to be posting either grumbling and complaints or excited fluff and noise.
notwithstanding the positive note struck by the comment and opinion in the article that you cite, you have to remember that it is now 5 months old and that it is US-centric. The US pharma-biotech market is far more risk-embracing than the risk-averse UK market. If you look through the PWC write ups on M&A over the last few years, they do a good job of highlighting how, during a downturn in global M&A in healthcare and lifesciences, it has continued to be the case that most action has been in the US. To assess where Valirx are in the big picture, you need to find examples of UK or European biotech being acquired or having key assets licensed by big pharma. There's very little evidence of that to point to. Big deals like Sanofi's acquisition of BioVerativ or the Takeda-Shire deal artificially inflate the numbers. Did anyone spot the relatively small value sell off of Shire's oncology business to Servier? "a bumper crop of deals"? If there's going to be, it's going to be a very busy H2!
To clarify, I wasn't directing the "blithering nonsense" remark at you. I think we can all name a few contributors to this board whose comments fall in to that bracket. The links I provided weren't meant to reference Valirx. Like I said earlier, you have to look at trends in the market. Are big pharma ready and willing to spend on M&A? Are we seeing patterns of mid clinical stage biotech being acquired or entering high value licensing agreements? I could name people who've died of cancer since I first invested in Valirx. I have close friends who work in senior clinical development roles for Cancer Research, primarily out of The Christie in Manchester. I ran 26.2 miles on the third Sunday in April to raise funds for CRUK. I'm with you in terms of patient benefit. But drug discovery and development takes time. Have a look at the chart: http://www.compoundchem.com/2016/01/16/drug-discovery/ With regard to financing, I'd encourage you to do some research as per my previous post
Those "patent paperwork exercises" are the difference between launching a product that is all but generic because it can be readily copied, versus launching a product that is the next oncology blockbuster and makes Valirx worthy of a multi-X's bid. Please research and understand the drug development and launch process properly before making comments like this. With the greatest respect, your admin person would get nowhere near processing an international scientific patent in oncology.
Have you communicated with Dr Morris or his colleagues? Have you explored what's going on with the withdrawn items from the AGM re wiggle room for financing? Have you looked in to the set up or not of an EGM to revisit those? Have you looked at the information in the public domain regarding Dr Dilly's approach to supporting the movement of 401 to phase 3 trials? Why assume "the next fund raise"? Such a negative assumption, though that's not to say it won't happen. Why not assume other eventualities?
https://www.pwc.com/us/en/health-industries/publications/pharma-life-sciences-quarterly-deals-insights.html https://www.pharmamedtechbi.com/deals This is the kind of insight that any PI either invested or considering investing in Valirx would do well to keep abreast of. It keeps your opinion informed and realistic and protects you from the blithering nonsense that some of the voices on here would like to scare or excite you with.
Whilst I appreciate your enthusiasm and am in agreement that we have a good portfolio of products, you have to carefully look at the market and think through what is reasonable and likely. Whilst you refer to "the big boys" - and wouldn't we all love for AstraZeneca, MSD or similar to launch a bid - you have to see if there's precedent for that kind of deal. That's especially the case if you're going to claim that "we have a pipeline worth billions". I might believe that my shares are worth �1 each, but the market disagrees and without a buyer prepared to pay my price, all I have is a fist full of shares. Likewise, a portfolio full of high potential assets. We have several mid clinical stage assets that big pharma would perceive as still relatively high risk. They have the potential to deliver billions in value given the size of the unmet clinical needs they seek to address. However, they could still fall over in late stage clinical trials. Let's retain hope, but equally, and for the sake of helping guard against the wild ramping and deramping trends that plague this board, let's be realistic and evidence our assertions with some good strong evidence from the pharmaceuticals market.
It never ceases to amaze me how people moan and complain here on LSE. I don't just mean regarding Sound Energy, but we're a strong case in point at the moment. What industries do you work in where deals worth hundreds or even thousands of millions are wrapped up in just a handful of weeks or months and without the benefit of years of careful R&D, operations, project management and commercial wranglings? Granted, there are those who approach investment on AIM like a day at the races with a quick glance at the going, a browse of the form guide and a hunch as to which nag looks least likely to fall at the last few fences. If that's you, all the best to you, but would you please shut up and leave the discussion space to us who've done some proper research? Your high energy noise contributes little of value. For those of us who have done our research and bought in because we perceive the potential for a brilliant result, let's show some patience. You may or may not get to buy a new motor, go on that holiday of a lifetime or pay off your mortgage this year, but surely next year is just as good?! So far as I can see, there are no signs of mismanagement or the BoD playing this like some kind of prop for a luxury lifestyle. I want JP to behave like a Chief Executive, not a newspaper editor, so I expect him to discreetly get on with his job and keep us informed as far as he is able and is appropriate. If anyone is in any doubt, this share price is being played. The salaries of traders need to be paid and the cash of private investors behaving like flighty bleating sheep and selling out in false panic will do them nicely. It also gives them a strong holding so as to sell in the rise that we can reasonably expect to see in due course. All my opinion and based on my own research to support my own investment of my hard earned cash (and quite a large chunk of it at that!).
Applegarth - there's credibility in your theory and I hope that it proves to be true. I would, however, sound a note of caution regarding the potential partners with whom we might strike a deal. It's unlikely that a tier 1, big name pharma would be interested in Valirx. Far more likely is a tier 2 or 3 - an acquisitive smaller player with aspirations to grow (doesn't everyone want to be like Shire?!) who have experience of getting products through late stage and launched. That would make it a name that many people wouldn't immediately recognise. Of course, there are other possibilities that aren't as clear cut as either the sale of 201 or a full licensing deal.
There are too many bombastic know-it-alls around and often plenty on here. I don't want to be counted among them. I posted "No Placing in May" on Friday morning. Clearly, I was wrong. As I understand it, resolutions 6 and 7 need to be passed at today's AGM in order to give the BoD some necessary room to manoeuvre. There was sufficient concern that these wouldn't be passed and so, taking up the flexibility they still had ahead of the AGM, they announced the placing. I'm not going to comment on what the share price is, what the terms of the placing were relative to it or how I feel about the whole situation. I've been in and around Valirx since about 2010/11. I'm fairly confident that one of my large holdings here is at an average that is far bigger than many of you that complain the most. I don't see that whingeing and moaning of the sort that so often fills this board is very helpful for anyone. As I said at the top, my apologies. It was only my opinion, but I was wrong.
Can I respectfully ask, ValJu, from your research, can you provide examples from amongst biotech peers of Valirx, where a similar product pipeline has developed as rapidly as you seem to suggest you expect of Valirx and with names of big pharma sniffing round it throughout? As far as I understand, from working very closely with people in clinical development and those leading M&A activity in pharma, there aren't immediate equivalents, certainly not on this side of the Atlantic. If any big pharma were in discussions with our BoD, it is unrealistic to expect that we would hear anything of that until a deal formulating process were underway. If you do not understand the pre-clinical science that has formed the basis of our portfolio being progressed from the laboratory to the clinic and if you do not understand the therapeutic areas and unmet clinical needs that our products are being developed for, it would be very worthwhile for you to undertake some thorough research.
Let's please put a stop to the speculation about a placing, at least, for the possibility of one happening in May. Unquestionably, clinical development is very expensive. I trust that contributors to this board undertake even some basic research before risking sounding stupid on here and, if you have, you'll have seen numbers that make the eyes water. Whilst there are many reasonable criticisms that might be put regarding some of the management approach of our BoD, one can equally point to a number of points at which they have saved huge amounts of money. The accelerated move to a phase 1b/2a trial for VAL201 is one example; the successful application for a phase 2b trial for VAL401 is another. There is no secret that more cash will be needed to continue clinical development of the portfolio. There is evidence in the public domain of Dr Dilly's ongoing efforts to attract investment to support VAL401. The BoD are exploring many avenues for funding of the rest of the portfolio. So why am I confident that we won't see a placing this month? https://www.sharesmagazine.co.uk/events/event/shares-investor-evening-edinburgh-310518 Much as Dr Morris is not a shy gentleman (!) I simply don't believe that he would choose to stand in front of a potentially hostile audience of private investors who have just seen their shareholding diluted. Is it possible that the presentation is a precursor to a potential placing in June? Yes, I think that would be a quite reasonable hypothesis, though no more than that. In the meantime, we can hope that long awaited updates on the VAL201 trial may be published.
Correct me if I'm wrong but, surely, if there is some kind of share price impacting news coming, the Directors would not be permitted to exercise their options at 4p if the price were to reach that mark before an RNS? Doing so would be insider trading, would it not?
I'm not invested here and have to confess that before last Thursday's presentation in Manchester, I'd not heard of the company. Jerry presented very strongly. He was confident and clear, balanced operational and commercial detail and pointed to where future success and growth is expected. I was left with two concerns: 1. Why was Jerry there and presenting? Is VLG flying under the radar and simply needing some PR to stir interest amongst PIs to trigger trading and get the share price moving? Is liquidity an issue? 2. The old saying "if it sounds too good to be true, it probably is". Cash in the bank, spare manufacturing capacity, increasing commercial deals, ... ... Where's the catch? Posting my reflections on the presentation and lingering questions here with no agenda other than to engage with those of you on here who are more fully researched and perhaps bought in as well.
boomorbust - sincere apologies, I didn't make it to the presentations last night. Got off the tram at Old Trafford and got a call to head to A&E for a clumsy family member who needed stitches! Sorry. Am going to have a watch of the presentations when published online. You're right about this being a lonely place! Doesn't exactly stir interest for an outsider looking in.
I’m heading to the presentation event at Old Trafford this evening. Have to confess that I’m not too familiar with this company, so will be listening and learning. Anything any long term holders or well-researched contributors on here would flag to me? Am happy to ask questions on behalf of any of you and will endeavour to live tweet (under the same username as on here) and even post to this board from the event.
I’m heading to the presentation event at Old Trafford this evening. Have to confess that I’m not too familiar with this company, so will be listening and learning. Anything any long term holders or well-researched contributors on here would flag to me? Am happy to ask questions on behalf of any of you and will endeavour to live tweet (under the same username as on here) and even post to this board from the event.