Shield Therapeutics Share Discussion Threads

[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.

[nobbygnome] 24/5/2020 12:34

I have spoken to him at length 1:1 on a number of occasions and he is not quite as you describe. He certainly has lots of ideas and came up with various different scenarios when I was talking to him. Admittedly Carl was much more of a showman but maybe that is not what you want when negotiating a complex deal where you have to be a detail person to sort out all the issues the other party has.

[daveboy1] 24/5/2020 12:29

My further take on him - Finance guy (different skill set), a bit wooden and uninspiring maybe to the workforce? That bloke that never comes to the pub because he's getting ready for the auditors coming etc. Hasty replacement just suggested to me a plan is already in the pipeline and perhaps he is a figurehead to bridge the gap. As ever, happy to stand corrected if he can pull the rabbit out of his WH Smith leather briefcase, instead of his chicken sandwiches that Mrs Watts made for him !!

[peachie 74] 24/5/2020 11:53

NG .... fair point.

[nobbygnome] 24/5/2020 11:37

>> peachie To be fair and balanced Carl did strongly suggest that a deal would be done before the end of 2019. In private conversations with him after various presentations last year he was very confident they would deliver in that time frame. In fact maybe that is part of the reason why he has gone because he talked a good story and didn't deliver. Famously at one Priactive presentation last Summer before the approval he said he expected a quick deal because 'every day the product is not on the market in the US we are losing revenue'! Here we are almost a year later with no immediate sign of a deal.....and they are indeed losing revenue.

[peachie 74] 24/5/2020 10:54

Morning Dave Fair enough. Let’s hope the Americans come in with an offer they can’t refuse ! I suppose from my naive point of view , I struggle to see how people know TW may or may not do a good job. He has no CEO experience, but surely that doesn’t mean he cannot be good at the job and excel. Most people’s judgements are I presume are being made at face value on the back of the brisk videos from Proactive investors etc. Personally I thought Frank Lampard might not be a good manager, but without experience in management he has done well ( bad analogy I know !). Behind the scenes he may be a great man manager , negotiator etc. I think he has just been judged on face value , when none of us know him. He may be useless! But also he may excel I would think the large shareholders might have an opinion ? Ewan post 3236 Lack of solid results ? Results in 2019-20..... FDA broad label approval Swiss approval Uptake by third of UK formularies H2H providing good long term results To be used moving forward Sales in Europe up 70% from 2018 I genuinely not sure what more you might want. The US deal , but that was never going to happen in 2019-2020 ?

[daveboy1] 24/5/2020 10:34

Morning peachie, Yes, that’s half of it. The other half (which ties in) is that Americans are, for the most part dynamic go getters who can vision what they want to happen immediately, and then plan around that. He’s not that, and a late substitute to boot. I’ve had direct experience of this in a company a relative owned and I had a stake in. Interested parties were just usurped by the Americans who came in with a knockout takeover offer that couldn’t be refused. They also made it blatantly obvious that they didn’t want anyone of the workforce from the top down as they had all their own people experienced and ready. Not saying it will go down like that here, just my direct experience. More than once as well.

[peachie 74] 24/5/2020 10:20

5. Conclusions Anemia is a frequent complication of patients with chronic IBD. Oral iron, including both the ferrous forms and the new ferric complexes, is effective and is recommended for the treatment of mild anemia. However, in the context of the COVID-19 health emergency, which requires maximum respect for the social-distancing rules and the reduction of nonessential hospital activities, the oral supplementation could be a suitable alternative for anemia therapy. We have learned an important lesson from the current pandemic and have provided an ambitious algorithm for the management of patients with martial-deficiency anemia, highlighting that patients can be managed at home and, only in urgent cases, in the hospital. Head-to-head comparative trials are needed to define which is the best oral iron formulation for the treatment of IBD patients with anemia. Author Contributions: S.D. and L.P.B. conceived of the study. F.D. wrote the first

[peachie 74] 24/5/2020 10:18

In relation to COVID...someone did ask ,, https://res.mdpi.com/d_attachment/jcm/jcm-09-01536/article_deploy/jcm-09-01536.pdf

[ewanwhose] 24/5/2020 09:25

I was looking to top up on the drop but I'm afraid that video has put me off. So much that should sound positive but somehow highlights the lack of solid results. If it wasn't for that nice up-front from ASK, I'd be comparing this to VRS.

[peachie 74] 24/5/2020 09:20

Out of interest , why is he not CEO material Dave. I have a medical , not corporate background , so have no idea Is that just your impression or based on factual knowledge about TW’s drive , ambition, negotiating skills, man management etc ?

[daveboy1] 24/5/2020 09:10

I’d go along with that summary, NG. My corporate experience of dealing with US ‘partners̵7; was they come along and want the whole thing, and aren’t interested in being second fiddle. I wonder if that’s the bit Carl didn’t like.

[nobbygnome] 24/5/2020 07:40

Don't forget they have a consultancy firm helping them sort out the deal too. I don't disagree that the management is looking a little flaky and perhaps that reflects actually they are close to throwing in the towel and might just get acquired. That would be a little disappointing but I think most investors ultimately would not be unhappy with that scenario. The bottom line is that despite the negatives which we can all see, the company is fundamentally undervalued because of the asset they have which is close to being licensed....or the company getting taken over!