Shield Therapeutics Share Discussion Threads

[daveboy1] 26/5/2020 09:57

Same here, but it's difficult to do much else when the latest interviews usually start with 'Well, we gained FDA broad label approval in 2019' ... Even my Nan knows that by now! :-)

[stevee1234] 26/5/2020 09:42

The new Chairman's CV looks as if he's been around quite a bit. I have no personal knowledge but it might be that he saw an opportunity for a more profitable approach and volunteered it and it has been adopted. He might be the deal maker and Tim his helper.
Maybe after the AGM things will start to happen, I'm sure some will start to get some idea of what's going on soon. Personally from my point of view it's all just guess work.

[daveboy1] 26/5/2020 09:19

That also sounds plausible when factoring in time delay, as it seems a lot has gone by when looking at what the company has publicly stated thus far. Also, from before, fits in with how Americans work. They want the whole thing I reckon, CS probably said no way.

[stevee1234] 26/5/2020 09:08

Yes I agree that is the obvious conclusion given that both appointments are from within, however with the European and Chinese deals done I wonder if it might be split up somehow.

[daveboy1] 26/5/2020 09:02

My pure guess is it could get gobbled up by a bigger fish.

[stevee1234] 26/5/2020 08:56

I think it's clear there has been a difference of opinion on the way forward for the company and the two new appointments are a direct result on a change of strategy. I am very keen to understand what this strategy will be, I wonder how long we will have to wait before we see it being enacted.

[daveboy1] 26/5/2020 08:38

Negative market reaction when people depart, and none when new ones are announced, as ever.

[stevee1234] 26/5/2020 08:11

From Tim Watt's comments it sounds as if the new CEO and Chairman come as a matched pair.

[nobbygnome] 25/5/2020 21:25

Apologies best, a flippant comment. Not in a good mood today....

[peachie 74] 25/5/2020 21:22

I don’t think it was reference to you as an investor. But we are where we are now, and so another month is frustrating but not the end of the world. The right deal is the most important thing.
It’s frustrating agreed. But I’m sure the company is trying all they can , pushed by some large II’s

[daveboy1] 25/5/2020 21:20

Nobby has never lost yet - fair play to the bloke, lol. 45p here. GL all.

[best1467] 25/5/2020 20:33

NBG I would hardly call Myself a short term investor I’ve been invested here from the mid to high 30/40p range along time before you came on board unless you were already invested prior to posting.
My comment was Based from the CEO comment it’s more likely Longer and let’s not forget we originally expected end of 2019 or Early 2020 I’ve no intention to offload will quite possibly add if it gets cheaper.
ButI’m frustrated with the running of the company and lack of clear communication they seem to have with Nordgine along with using the wrong protocol in confirming the H2H study Results

[daveboy1] 25/5/2020 12:31

Afternoon peachie - great find there, cheers. I hope they do push home all these points to bolster any arrangements. Surely cost saving is a big advantage factor here, and in the corporate world, especially now, cash is king as was said earlier by another poster. I know it's been said before, but I can't see why they haven't got this product out there by now generating revenue and garnering acclaim.

[stevee1234] 25/5/2020 11:19

Very interesting article Peachie, thanks for posting.

[peachie 74] 25/5/2020 10:38

Interesting point raised in the above article regarding lost income from missing a days work for IV delivery. I wonder how much Licensing companies will push this point as a sales pitch ?

[peachie 74] 25/5/2020 09:08

Very interesting section from medical paper link posted above re ferric Maltol/Feraccru......


3.3. Ferric Maltol
In recent years, a new oral iron therapy composed of a complex of ferric iron (Fe+++) and maltol, a sugar derivative, has been developed and is now available [29]. Free iron can damage the intestinal mucosa and modify the gut microbiota [29]. The ferric maltol complex makes iron stable and prevents the formation of iron hydroxide polymers, increasing iron bioavailability and reducing the risk of mucosal toxicity [29]. A randomized Phase 3 study evaluated the efficacy and safety of ferric maltol in IBD patients with iron-deficiency anemia who were unresponsive or intolerant to oral ferrous forms [20]. The drug allowed a rapid improvement in Hb values, since there was a mean Hb increase of 1.04 g/dL, compared to the placebo, after four weeks of treatment [20]. Furthermore, the mean Hb value in patients treated with ferric maltol was significantly higher than in the placebo group, after 12 weeks, with a mean Hb increase of 2.2 g/dL [20]. There was no difference in treatment compliance between the two groups (98% for both arms), and the percentage of adverse events between the experimental group and the control group was comparable (58% vs. 72%, respectively), indicating a good drug safety profile [20]. Long-term extension data of this Phase 3 trial confirmed the efficacy of ferric maltol [21]. In fact, 97 of the 111 patients who completed the first 12 study weeks were enrolled in an open-label trial, receiving ferric maltol 30 mg twice a day, for an additional 52 weeks [21]. Patients who were treated with the placebo in the previous phase were switched to oral iron [21]. A mean increase of 3.07 g/dL in Hb concentration was found after 64 weeks of treatment [21]. Interestingly, an Hb mean increase of 2.19 g/dL was reported in the switch population [21]. Resolution of anemia occurred in over 80% of patients, and adherence to therapy was maintained in 84% of cases [21]. The drug appeared safe, as only 27 patients (24%) experienced drug-related adverse events (abdominal pain, constipation, flatulence, and diarrhea), and most of them were mild or moderate in intensity [21]. Similarly, a recent Cochrane review highlighted an acceptable safety profile for ferric maltol, as fewer adverse events and serious adverse events were reported in patients treated with ferric maltol, as compared to the placebo (51% vs. 71% and 8% vs. 13%; low certainty

J. Clin. Med. 2020, 9, 1536 6 of 10
evidence for both findings) [22]. Furthermore, preliminary data from an ongoing observational cohort study showed that two-thirds of the patients treated with ferric maltol achieved normalization of Hb levels after three months of oral supplementation in a real-life setting [23]. A real-life cohort study investigated IBD patient′s tolerability toward ferric maltol [24]. It was well tolerated by 67% of patients, and 50% of patients, who did not tolerate other oral forms of iron, tolerated ferric maltol [24]. Recently, an open-label, Phase 3B non-inferiority trial compared ferric maltol and intravenous iron, focusing on the loss of productivity in IBD patients [25]. Ferric maltol was not inferior to intravenous iron to achieve normalization or increase in hemoglobin values of ≥2 g/dL after three months of follow-up [25]. Oral iron was not associated with a reduction in productivity [25]. In contrast, 50% of the intravenous group patients lost at least one day of work, and 6.7% of them lost four-to-six working days, causing up to 775 € of daily losses per patient [25]. Interestingly, the physical component summary of the short form health survey (SF-36) and the mental component summary (MCS) values were slightly higher (p-value not significant) in patients treated with oral medication, suggesting a greater improvement in quality of life at the end of the study period [26]. In addition, total treatment costs per patient were lower in the oral drug group than in the intravenous arm (302.27 € vs. 489.37 €, respectively) [27]. Influencing factors on the high cost of intravenous treatment were not only the greater cost of the drug, but also the number of hospitalizations/outpatient visits for each patient (2.30) [27].

[nobbygnome] 25/5/2020 07:32

>> best

Oh dear, you mean you might have to wait a whole one more month.....it is tragic everyone is so short term these days!

[peachie 74] 24/5/2020 22:40

FinnCap 22/05/2020

Shield Therapeutics (STX): Corp
FY 2019 results
Shield reported FY 2019 results that showed sustained momentum from Norgine’s promotional activity of Feraccru in England and Germany, with in-market pack volumes c.70% higher than in 2018. Revenues of £0.7m compared with £11.9m in 2018, which included £11m of milestones. This resulted in an adjusted net loss of £6.3m (vs +£1.1m). Net cash at 30 June was £4.1m, providing a cash runway into Q1 2021, which excludes potential significant up-front payments and milestones for US rights to Accrufer, which are currently being negotiated. Despite minor changes to forecasts, reflecting the later-than-modelled introduction of Feraccru/Accrufer into the broader EU market and US, we reiterate our 350p target price, which reflects the long-term nature of market exclusivity, peak market share (20% assumption) and rolling forward the start year for our DCF calculation, rather than near-term sales. This excludes the potential value of the US milestone, which we have stated in the past could be $50m with $100m+ of commercial milestones.

[peachie 74] 24/5/2020 21:59

“Our UK manufacturer is currently working on a campaign to manufacture around 12.5 metric tonnes of ferric maltol which should be completed by the end of September 2020. This will provide us with sufficient API to last throughout 2021.”
Quote from trading update

So what does 12.5 tonnes relate to...

7.4m bottles of 56 caps at 30mg each. A lot. If you guess a 20% royalty on gross revenue and a UK list price of £47.60 in all markets that is £70m from that one order of API. If anyone gets a different number , fire away ..... Not insignificant!

[nobbygnome] 24/5/2020 20:13

>> ewan

It is patently clear that we haven't got a US licensing deal yet. It also clear that in the short term the signing of said deal will be the value driver particularly from the current lowly level. Simples!

[peachie 74] 24/5/2020 16:54

Fair enough Ewan. Perhaps better you don’t top up then. Good luck.

[ewanwhose] 24/5/2020 15:44

Peachie,I may be showing some lack of knowledge of the pharma processes (in which case I am very happy to be enlightened) but the 'solid results' I was expecting were :US outlicencing. The lack of this is an increasing concern and moving towards a 'red flag' if we don't get something in the revised timescale of H1/2020 (just over a month away). We were in discussions with potential licencees even before FDA approval. Commencement of sales into Europe ex UK and Germany. I thought that Norgine would crack on with that, but it seems they are still some time away from commencing sales. Development of Australia and New Zealand. I have found nothing on this since the announcement. We aren't even mentioned on the norgine.com.au website.Big increase in UK and German sales. 67% increase looks impressive initially but arguably not from a low start and comparing our small, specialised and cash-strapped sales team against the might of Norgine's machine.It would be reassuring if you could counter the above points, because I am increasingly nervous. Thanks!

[peachie 74] 24/5/2020 12:48

Haha. Dave you shouldn’t judge a book by its cover !
A finance guy is perhaps what they need atm

[daveboy1] 24/5/2020 12:44

Yep, fair enough. You've met him and I haven't. Hope it works out for everyone concerned in the not too distant future. Fingers crossed etc.