Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
Sam, it just shows how utterly useless the NHS really is when they are still saying the indication is for Anaemia and IBD! The UK is too poor, too focused on cost rather than outcome, and too small in the market to make any difference to Shield's outcome. It is ALL about progress in the US and China.
Yes, but he is not allowed to know that the numbers are good, or looking good, or likely to be good, and not release that information to the market immediately.
DaveBoy, AIM rule no.11: General disclosure of price sensitive information
11. An AIM company must issue notification without delay of any new developments which
are not public knowledge which, if made public, would be likely to lead to a significant
movement in the price of its AIM securities. By way of example, this may include matters
concerning a change in:
— its financial condition;
— its sphere of activity;
— the performance of its business; or
— its expectation of its performance.
I'd be surprised if a placing is announced. I recall there is funding to the end of the year. That would put them on the road in the third quarter. They won't be in any hurry for a funding round with the sp where it is. They may be holding out to show some traction in the markets with the hope it'll boost the sp. Problem being, if they did have any traction to show they would be legally obliged to share that data as soon as possible, as it's material to the sp, and they haven't. So we can assume that's not the case as of figures to end March. They may be able to argue that figures for April are not fully consolidated as yet.
Good points. US launch is an easy milestone to meet. More milestones like that please! Tim pumped price on the fact a US deal would be signed, and then paid the price when it didn't materialize. From what I understand, the 30p placing should have been 40p, right up until the last minute, when they were again naive. The fact though is that for anyone who has looked at the fundamentals of the drug and its competition in the market, and taken into consideration the fact it already has broad approval in the US and Europe, it is a no-brainer that this will eventually be a billion dollar company. That might not have been possible with a US partner. With self-commercialization it is a very real prospect. The potential upside is so much greater. So perhaps we should be thankful for the way things have played out.
It would have been sensible to use that wording in the original. But changing it now ... sigh.
The former CEO was the driver. Tim filled vacuum when he left. There was so much interest from US companies in a deal (and a deal was just ink on paper away from being done on at least one occasion) that it was almost inconceivable it wouldn't happen. The mistake that was made was letting the market know this and putting a "deadline" on it. That was entirely unnecessary and so everything that followed -- including the 30p debacle -- was self-inflicted. You would have thought the lesson would have been learned. So why on earth give yourself a June deadline on US operations when other factors could intervene to delay a few weeks, a month, or two?
Hi Shandy - I've been in this share since day one. The 2017 dip was due to a failed trial. It was later discovered that doctors in the trial were topping up iron for some participants on the control side, those patients were eliminated from the study, and the results were confirmed as positive for the drug. But the fail had immediately been released to the market, as required, the share price had tanked, the damage was done. There was no way back. Prior to its Aim listing, Shield was tantalizing within couple of days of a main board listing when the markets crashed and funding disappeared. Things would have been very different with a $300m+ valuation on listing. The former CEO's favoured route to market in the US was always self-commercialization, but the VC blocked it at every turn. That relationship was never good after the initial funding round. Follow that through to last year's admin slip in the head-to-head data release and the mechanisms behind the departure of the former CEO last year can easily be deduced.
There would seem to be a very good chance STX will get taken out if FDA approval is forthcoming later this month. At the current market cap, it will be a no brainer for any company that was looking at a licensing deal in the US. The only question is, at what multiple on the current share price, x2, x3, x4, ... ?
Never any guarantees. Not with Motif Bio (in which I was invested), not with Shield, and not with life in general. Saying so really is no more than stating the obvious.
However, one difference is that a knock-back for Shield from the FDA won't kill the company. Feraccru is approval in Europe with a wide indication and a favourable licensing deal, sales under way, milestone payments coming in and cash in the bank. If approval in the US isn't forthcoming, for whatever reason, it simply addresses the problem and goes again. And in the meantime gets on with business elsewhere.
So it is considerably de-risked in comparison with Motif bio, which might live to fight another day, but currently has no clarity from the FDA (last time I looked), is running on fumes, has no income, and a cash call is imminent.
Any new funds Motif is currently negotiating are likely to come at a valuation heavily discount against the current share price because the company has it's back to the wall. And without clarity from the FDA, it's a punt. And that would hit investors (who didn't see the same kind of rise ahead of the pdufa date that Shield is seeing) hard ... again.
92p and rising ...
Yes, now 81p.
Looks like sp will continue rising into the July pdufa date.
If successful with New Drug Approval in the US, as seems probable, given the fact the drug is already widely available in Europe, Shield will seek a licensing deal with a US partner similar to the very good one done in Europe in September.
Given the attractive market cap, sensible money would be on Shield getting taken out for a high premium on the sp at that time. If there were any competition in the bidding process, given projected revenues over the patented period we would likely be looking at Shield being taken out for a multiple of the share price at some point later this year.
STX continues to rise and with a pdufa date in July you have to expect that looking at its current market cap it will double again before then. Similar stage companies in the US are valued around 0.5bn and STX still under 0.1bn.
I'm afraid calamari is right. This seems to confirm that this is a safety issue the FDA had clearly raised with the company such that it went out and got opinions from three liver experts. The fact that they were aware of the issue and "provided a comprehensive response" but failed to convince the FDA IMO strongly suggests new trials. (The.Italian - they would be on dodgy ground legally if they tried to cover the fact they provided these opinions, as I'm sure the lawyers will have advised.)
That means new funding. So the question is, how much dilution? That will depending on timing. Which will depend on how much cash the company has left. Does it have enough cash to carry it through a meeting with the FDA before it raises funds? If not, and it has to raise funds before any such meeting, then any investor would not have clarity re. the fda. That investment then becomes a massive gamble, which coupled with the fact that Motif might have no option but to accept money at whatever level it was offered, is likely to mean it would only be offered at a very substantial discount on the current valuation. Beggars can't be choosers.
If they do have enough money to take them through a meeting with the FDA before starting a fundraise, the position might be better. But only depending on the outcome of the meeting. Which is anybody's guess. Hmmm
Very interesting, given this failed patent challenge came from Teva, who are clearly extremely worried Shield's Feraccru is about to replace their annual billion-dollar-plus Ferinject intravenous iron market with a simple pill
Nda is a collaborative process and this drug was on priority review. Liver tox is the concern with this class of drugs. Hard to believe it never came up. More likely Motif was asked for data (if it hadn't provided it up front) and the FDA wasn't convinced. Which likely means new data is required. Which will mean new funding is required
The Pdufa is the latest date the FDA can give it's decision. It can always play a joker and push the decision back. But in that case, it would have had to inform MTFB. And MTFB is then legally bound to release the information to the markets at the earliest opportunity as it is material
But the FDA doesn't always fall over itself to share its decisions. I've heard of companies awaiting various FDA decisions/communications phoning three days after the expected date only to be told a letter is in the mail. I don't think this necessarily applies to PDFUA decisions, but it gives an idea of how they roll over there in Maryland
If that is the case, then the company is legally obligated to release the information at its earliest opportunity, as it's clearly "material"
I’ve been holding MTBF for nearly a year and regularly follow this chat but rarely make comments. I have two stocks that hang on pdufa dates in my portfolio. The other is Shield Therapeutics. Can anyone enlighten me as to why STX is up from 15p to 58p over the time I’ve held MTBF based primarily on its FDA filing while MTFB has barely moved? STX now seems to have gathered momentum and continues on a strong regular upward curve. My broker tells me new funds are getting in now with a pdufa date in late July and it is likely to continue to print higher. Why not MTFB?