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Shield Therapeutics PLC Heading for a US approval decision

Shield Therapeutics PLC Heading for a US approval decision

Shield Therapeutics (LON:STX) is making excellent progress having reported two sets of new supportive clinical data on its lead product Feraccru, a low dose oral iron capsule. Feraccru is being positioned as an alternative therapy for patients with iron deficiency (ID) and iron deficiency anaemia (IDA) unable to tolerate or unresponsive to first-line oral iron tablets and as an alternative to second line invasive intravenous (IV) iron.

  • New data from AEGIS H2H multi-national phase IIIb randomised, active-controlled trial, announced in March, showed non-inferiority to a market leader Ferinject. The latest head-to-head data is compelling and presents a clear commercial challenge to market incumbents.
  • The value of the iron replacement market is approaching $3bn, while Ferinject achieved FY18 in-market sales of CHF 900m in a global IV iron market worth $1.8bn, according to IQVIA. Sales in some geographies are growing at a double-digit rate. Feraccru’s convenience could lead to better compliance and improved penetration – growing the overall market size.

  • The positive outcomes triggered a €2.5m development milestone receivable from European/Australasia license partner Norgine out of total potential development and sales milestones of up to €54.5m over the life of the deal.

  • Phase III AEGIS CKD (chronic kidney disease) long-term follow-up study results announced in January showed that Feraccru’s long-term efficacy and tolerability was maintained at 52 weeks, having met the original primary endpoint at 16 weeks (announced in 2018). The study provided additional evidence of the maintained benefit with continued Feraccru therapy, a lack of relapse and therefore no requirement for IV iron.

  • We contend that Feraccru can command a high market share as well as premium pricing because of its convenience and supported by further evidence emerging from clinical studies that it provides a long-term treatment for maintaining the body’s iron stores, thereby preventing recurrence of IDA.

  • If the US approval decision is positive, Feraccru has a strong data package to support partnering discussions and facilitate commercial success. A late-stage asset such as Feraccru would likely command attractive royalties as well as upfront and commercial milestone payments.

  • Shield has a cash reach into Q320 on its end-December 2018 net cash position of £9.8m.

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Shield Therapeutics PLC Timeline

Related Researches

April 09 2019

  • Avacta Group PLC (LON:AVCT) reported interim results to January 2019, confirming good progress on key development programmes
  • Lead immune checkpoint inhibitor programmes continue to move towards in-man clinical data in 2020
  • Major development partnership and licence agreement with LG Chem potentially worth more than US$300mln plus royalties, announced in December
  • Post-period end, the additional licensing deal with Moderna provides further validation of Avacta’s Affimer platform
  • Appointment of Jose Saro as the chief medical officer strengthens Avacta’s capabilities for evolving from pre-clinical to clinical
  • The Research and Diagnostic Reagents business reports a record sales pipeline

Avacta (LON:AVACT) reported revenues of £1.0mln, down from £1.5mln the year before, largely due to the absence of research services revenues for FTEs working on the Moderna collaboration now that assets have been transferred into their development pipeline. We expect revenues from the LG Chem deal to offset this during the remainder of 2019.

The company reported a cash outflow from operations of £2.9mln and ended the period with £11.8mln net cash following the £11.6mln fund-raise in August. We believe that Avacta can comfortably fund ongoing development programmes into 2020.

The company will be moving its year-end from July to December, meaning that the current year will be reported on the basis of a

17-month period (see table below).

July 30 2018

Avacta Group Plc (LON:AVACT) has recently finalised a co-development partnership with Boston-based Bach BioSciences, to exploit the potential of the Affimer platform for the development of a novel class of drug conjugates.

September 03 2018

Legendary Investments (LON:LEG) creates value through privately held and pre-market investment opportunities with the potential for outsized returns. The company has a strong track record with:

  • Total investments valued at of £6.2mln (from zero in 2011)
  • Out of 12 investees in total, five are exhibiting multiple returns from 1.3x to 35x
  • Two crystallised with exits at a multiple of the initial investment

We believe this is an interesting time to revisit the investment case, as the shares are currently trading at a discount to net asset value (NAV), which has not been the case in the past.

N.B. Legendary plans to change its name to Eight Peaks Group (LON: 8PG) in the near future.


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