Market update post FDA meeting

6th April 2018

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Agenda

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Today’s announcement, vision and ambition

Topic

Carl Sterritt, CEO

Speakers

Feraccru® study details Dr Mark Sampson, CMO

Feraccru® US next steps Carl Sterritt, CEO

Q&A

Today’s announcement

Results of Shield’s Pre-NDA Submission Meeting with FDA: Confirms plans to submit New Drug Application for Feraccru® as soon as possible, provides a strategic review update and announces appointment of Non-Executive Director

Vision & ambition

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We aim to transform patients’ lives by helping them become people again, by enabling them to enjoy the things that make the difference to them in their everyday lives, whilst delivering value to all of our stakeholders

One drug product in one indication

Today

Leverage Feraccru across adjacent indications & expand geographies

Near term

Build a sustainable, profitable specialty pharma company

Ambition

Feraccru® profile

1Iron deficiency anemia2Inflammatory bowel disease

Novel oral, twice a day, (tablet) ferric

iron therapy

Now approved in Europe for the

treatment of ID in adults

Non-salt

Simple oral administration

Efficient absorption

Rapid Hb rise

Placebo-like safety

More cost effective than IV

Taken without food

Important advantages and differentiated mechanism

of action compared to current standard-of-care

for IDA

Geographic and label expansions expected to increase Feraccru’starget patient population *

First-line therapy, salt-based oral irons

Current standard-of-care IDA

Second-line, intravenous irons

* Now approved in EU for Iron Deficiency

AEGIS-CKD Readout

Dr Mark Sampson

Overview of non-dialysis dependent chronic kidney disease and iron deficiency anemia

Chronic kidney disease (CKD)– Chronic progressive condition– “Renal” diet limits protein and can lead to low iron intake– Iron absorption poor with iron salts– Increases blood loss through kidneys

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*Centers for Disease Control and Prevention. National Chronic Kidney Disease Fact Sheet, 2017

Overall prevalence of CKD in the United States is c.14%*

Anaemia is a major complication of CKD

Average of 15.4%of patients having anemia

Prevalence increases with the stage of CKD, rising from around 10% at stage 1 to approximately 55% at stage 5 and is associated with:

• Fatigue, lethargy, decreased quality of life and is also believed to be associated with cardiovascular complications, hospitalisations, and increased mortality.

• As with IDA, due to other diseases, currently available oral iron supplements are associated with limited efficacy and dose-limiting tolerability issues.

Kidney damage w/ normal GFR1 ≥90

Description eGFR (mL/min/1.73m2)Stage

Kidney damage w/ mildly reduced GFR2 60-89

Mild to moderately reduced GFR 3a 45-59

Moderately reduced GFR 3b 30-44

Severely reduced GFR4 15-29

Kidney failure5 <15 or dialysis

Normal Kidney Function

CKD background and staging

Sources: Mayo Clinic; National Kidney Foundation; National Kidney Disease Education Program

CKD Clinical staging

ST10-01-303 Study Schema

ScreeningUp to 14

DaysRandomisation

Ferric Maltol30mg bd

Placebo bd

36 week open label Ferric Maltol 30mg bd

End of studyWeek 52

Telephone Follow up

16 week double blind phase

A Phase 3, Randomized, Placebo Controlled, Prospective, Multicenter Study with Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects with Chronic Kidney Disease

Change in Hb from Baseline (g/dL) – ITT*

ITT: intention-to-treat *Based on SAP V1.0

0.19

0.51

0.45

-0.01

0.05

0.15

-0.1

0

0.1

0.2

0.3

0.4

0.5

0.6

Week 4 Week 8 Week 16

Hb–

g/dl

Feraccru Placebo

p = 0.0009

p = 0.1686

N=56N=111

Concomitant Medications – Not permitted

• IV iron injections, intramuscular or depot iron administrations• Single agent oral iron supplementation, taken specifically to treat anemia (e.g. ferrous

sulfate, fumarate and gluconate) • Ferric citrate or sucroferric oxyhydroxide• ESAs• Blood transfusions or donations• Dimercaprol, chloramphenicol or methyldopa

Removal of subjects from study criteria (selected)

• Use of prohibited concomitant medications• Initiation of dialysis• Blood transfusions or donations for any cause• Any dose or frequency changes to myelosuppressants during the double-blind treatment

period• Requirement for major surgery. Minor surgeries not associated with significant blood loss,

in the Investigator’s judgement, are permitted (e.g. surgery related to fistulae or vascular access, minor dental extractions, incision and drainage of abscess or simple excisions)

Summary of Subjects with Data Removed from ITT Analysis as a result of Confounding Events

Event Ferric maltol subjects Placebo subjects

Haemorrhage1 2 0

Haemorrhagic anemia 0 1

ESA 4 0

RBC/RBC concentrate 3 0

Haematochezia 1 0

Blood/Blood related products 0 2

IV iron 0 3

Ferrous sulfate 3 2

Total (N) subjects 13 8

ESA: erythropoietin stimulating agent; RBC: red blood cell; IV: intravenous; 1. Gastrointestinal haemorrhage (1), haemorrhoid haemorrhage (1)

Change in Hb from Baseline (g/dL) – ITT (MI)*

0.16

0.49 0.5

0.03 0.03

-0.02

-0.1

0

0.1

0.2

0.3

0.4

0.5

0.6

Week 4 week 8 week 16

g/dL

Feraccru

P=0.3259

P=0.0149P=0.0052

N=56N=111

ITT: intention-to-treat; MI: multiple imputations*Based on SAP v1.1

Change in Hb is more apparent by week 16 in subjects with serum ferritin <250ng/ml

Change in Hb: Ferritin <250ng.ml Change in Hb: Ferritin >250ng.ml

Summary of Ferritin (µg/L) (ITT - LOCF)

Visit Mean (SD)

Ferric Maltol (N=111) Placebo (N=56)

Baseline 97.03 (88.499) 104.21 (80.035)

Week 4 101.32 (86.768) 98.23 (78.813)

Week 8 108.20 (91.739) 96.77 (73.622)

Week 16 123.22 (109.003) 94.57 (78.982)

ITT: intention-to-treat; LOCF: last observation carried forward

Analysis of Change (ANCOVA) from Baseline in Ferritin (µg/L) at Week 16 (ITT – LOCF)

Assessment LS Means (SE) LSM Difference (SE)

95% CI p-value

Ferric Maltol

Placebo Ferric Maltol -Placebo

Week 4 4.23 (2.360) -5.87 (3.328)

10.10 (4.088) (2.029, 18.174)

0.0145

Week 8 10.93 (3.429)

-6.96 (4.836)

17.89 (5.940) (6.160, 29.620)

0.0030

Week 16 25.49 (5.400)

-8.25 (7.614)

33.73 (9.354) (15.264, 52.205)

0.0004

ITT: intention-to-treat; LOCF: last observation carried forwardLS = Least Squares; SE = Standard Error; LSM = Least Squares Means; CI = Confidence Interval

Feraccru® US next steps

Carl Sterritt, CEO

Adults in the US with IDA related to CKD

1US Rental Data Service 2017 Annual Report

31m CKD

16m CKD 3-5

15.5m CKD 3+

4m

661 K

468 K Dialysis

Renal Failure

193 K Transplanted

Non- Dialysis

14% of the Adult Population (244m)

7.7%Age 20+

26.4% Stage 3+4 Anemia (Stauffer et al)

Anaemia

Key messages and near term news flow

AEGIS-CKD study will be filed with US FDA as soon as possible• Timelines will be communicated in due course

AEGIS-CKD results highlights • Study meets primary endpoint (change in Hb from baseline at 16 weeks ) when

confounding measurements are excluded from ITT analysis• Change in Hb already statistically significant at Week 8• No additional pivotal clinical trials needed• Work will be funded within current cash resources

Strategic review update• EU licensing options• US market opportunity for Feraccru

Group’s 2017 preliminary results – 11 April 2018

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Q&A