Improving lives together

H1-2016 Interim Results, 20th September 2016

Carl Sterritt, CEORichard Jones, CFO

Paul Steckler, VP Commercial Ops

DisclaimerThe information contained in these slides has been prepared by Shield Therapeutics plc (the "Company"). It has not been approved by the United Kingdom Listing Authorityunder the Prospectus Rules (made under Part VI of the Financial Services and Markets Act 2000) or otherwise, or by the London Stock Exchange plc. Nothing in these slides,nor in any information communicated to you in the presentation of these slides, constitutes or forms part of any offer for sale or solicitation of any offer to buy or subscribefor any securities nor shall these slides, such presentation or any part of them form the basis of or be relied on in connection with, or act as any inducement to enter into,any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information or opinions contained in these slides or thepresentation of them or on the completeness, accuracy or fairness thereof.

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3

Highlights(including post period end)

Operational

• 1st revenues of £240k from sales of Feraccru, following MA approval

• Initial stages of Feraccru’s European commercial launch progressing in line with expectations:

– UK commercial activities accelerating as per plan with access to Formularies and approvals by CCGs being achieved to cover an increasing number of prescribers

– Now >10 members of Shield Therapeutics’ team interacting with UK customers on a daily basis

– Feraccru pricing of £47.60 per 28-day treatment pack agreed with the UK NHS

– Higher pricing of €64.00 per 28-day treatment pack agreed and published in Germany, with sales operations to commence in October 2016

• Key Composition of Matter patent granted, significantly increasing the level and duration of intellectual property protection afforded to Feraccru from 2023 to at least 2034

• AEGIS-H2H and AEGIS-CKD Phase 3 studies of Feraccru progressing on track

• Discussions progressing well with potential licensing partners in some non-core markets

• PT20 and PT40 activities continue in-line with plan

4

Financial1

5

• Successful completion of an IPO on AIM raising £32.5m (gross) and further potential gross proceeds of £17.5m, subject to the full exercise of Warrants

• First reported UK revenues of £240k

• Net loss for period of £8.9m on an IFRS basis. Adjusted net loss for period of £5.1m1

• Period end cash balance of £28.4m

1Note: the Company’s 2016 interim results include certain items relating to the structure of the group pre-IPO and pre-acquisition of Phosphate Therapeutics Limited which completed in February 2016.

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Feraccru launch progress

• UK commercialisation gaining traction

– DoH has agreed £1.70/day & formulary access opening across England (~84% of UK opportunity)

– >10 field-based headcount working across key disciplines (Prescribers/Clinical Commissioning Groups (CCGs)/Formularies) in the UK

• Germany launch plans

– German price now published at €64 per pack (€2.29/day)

– Significant promotional presence at DGVS (German gastro meeting) in Sep-16

– German team readying for launch (based in Munich) with Medical Science Liaisons in the field

– Sales Representatives (x8) and Sales Manager provided by Inventiv Health:

i. more streamlined start-up logistics in 1st overseas market and

ii. ability to ‘try before we buy’

• Continued planning for rest of EU5

– Considering the premium price-points achieved in UK and Germany, and following specialist research/advice:

i. France to launch after H2H data available to facilitate optimum pricing in ‘price giving’ market

ii. Similar specialist research ongoing in Spain and Italy

7

Shield core markets

Inward enquires

AOP Pharma

Non-core markets

Active discussions

Business development

8

• AEGIS-H2H

– ~50 sites in total to be opened in Europe and the USA

– Recruitment momentum building as expected:

• 66% of sites in Europe have screened patients

• >50% of sites in Europe have recruited patients

• Screening to randomization ratio running at a very healthy 2:1

– US patient recruitment anticipated to commence in October and will facilitate a more efficient

NDA pathway

– Guidance on timing of data read-out remains H1’17

• AEGIS-CKD

– Trial sites being selected and initiated in the USA

– First Patient In (FPI) expected in Q4-16

– Pivotal data expected to be available as previously guided

9

Clinical development

10

• Data and Marketing exclusivity applied to Feraccru in EEA – Provides protection through to Feb-26

• Patent #12 (composition of matter on polymorphs of ferric maltol)– UK grant received– Subsequent applications ongoing in Europe, US, Canada, China, Japan, South Korea, Australia &

India

• Patent #5 (manufacturing & formulation)– 5yr SPC extension application made following MA approval

• Patent #7 (use in achlorhydria)– US grant received

• Patent #15 – Interesting new application filed re Hepcidin

Significant IPR progress

Financial performance

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Results - P&L

H1’16£’000

H1’15£’000

2015£’000

Revenue 240 - -

Gross Profit 180 - -

Operating costs (S,G &A) 4,964 574 1,371

Other operating income 40 120 221

Reseach and development 787 1215 (5,284)

Operating loss 5,565 1,669 (6,434)

Financing costs1 (18,054)

Net Loss (8,851) (30,027) (24,488)

Adjusted net loss (5,081) N/A (5,279)

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Results - Balance sheet

13

H1’16£’000

H1’15£’000

2015£’000

Intangible assets 27,550 514 530

Current assets 29,883 3,803 2,330

Total assets 57,433 4,317 2,860

Current liabilities (3,159) (13,171) 3,575

Non-current liabilities (3,159) (52,790) (17,928)

Total Liabilities (3,159) (52,790) (24,488)

Net Assets/(Liabilities) 54,274 (48,473) (18,643)

Results - Cashflow

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H1’16£’000

H1’15£’000

2015£’000

Cashflow from operating activities

(4,394) (1,283) (4,183)

Cashflow from investingactivities

(1,383) (94) (132)

Cashflow from financing activities

33,507 4,563 4,563

Net increase in cash 27,730 3,186 248

Cash at start of period 725 477 477

Cash at period end 28,455 3,663 725

Accounting items post IPO

• R&D capitalisation- new components relating to R&D Projects for Feraccru in approved indication (IBD):

– Phase 3 H2H study costs (amortised over patent life)

– CMC relating to Feraccru project, excluding COGS (amortised over 5 years)

– Associated regulatory costs

– External costs only, no capitalisation of internal costs

– In total £0.9m capitalised in H1’16

• Share based payments– Related to LTIP awards in H1’16

– Hurdle rate of CAGR in share price of 11.47% each year for three years

– Std option pricing models used

• PTL acquisition- £27.0m capitalised under intangible assets representing fair value of the acquisition in February 2016.

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Future newsflow

16

EMA approval of Feraccru

Feraccru launches in UK in

IBD (first reference price)

H2H study starts

Phase IIIb 12 week data (H2H vs. IV)

results for Feraccru

Feraccru launches in Germany

(second reference price)

PT20 out-licensing opportunities

Label expansion in Europe based

on further clinical data

Feraccru US approval

2016 2017 2018 2019

H1 H2 H1 H2 H1 H2 H1 H2

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Shield Therapeutics’ key value-driving events through 2019

CKD study starts

Feraccru US label phase 3 data readout

Feraccru launches in Austria and

Ireland

Feraccru to launch across a wider set of European markets

1st non-core market out-

licensing deals for Feraccru

Summary

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• Feraccru’s initial commercial activities progressing to plan

– First revenues generated in the UK with promotional activities well underway alongside

reimbursement activities at both CCG and Formulary levels

– German launch is imminent and attractive pricing of €64/pack achieved without HTA review,

further supporting high value proposition of Feraccru for stakeholders

– Licensing: actively pursuing discussions in a number of non-core markets

• Feraccru’s further clinical development progressing as plan in both phase 3 studies

• Significant value enhancement achieved through granting of composition of matter patent

• Financial performance in line with expectations

• Identifying opportunities that would more rapidly build a presence/revenues in key

geographies or provide a broader product portfolio

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Summary

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Appendix

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Oral Iron Tolerant

Able to take oral ferrous iron products (OFP)

Many patients are intolerant of OFP, especially those with other diseases (e.g. IBD, CKD)

Intravenous Iron (IV)

Simple oral administration

Efficient absorption

Rapid IV-like effect

Placebo-like safety

More cost effective

Iron directly into the blood But:

– Allergic reactions– Iron overload– Hospital only– Resuscitation team required– High overall cost

No patients in long term study of Feraccru required interventional IV therapy

• IDA arises in diseases like Inflammatory Bowel Disease (“IBD”), Chronic Kidney Disease (“CKD”), Congestive Heart Failure (“CHF”) and in women with excessive uterine bleeding etc.

• Failure to treat leads to lethargy as well as much more serious consequences (e.g. immune & heart complications)

Feraccru overview A compelling alternative to IV iron

Fe2+

Fe2+

Insoluble complexes + Radicals

Gut damage side effects

Fe3+ cannot be oxidised – no radicals

Iron remains soluble

High iron channel affinity

Patient diagnosed with Iron Deficiency Anaemia

(IDA)

Oral Iron Intolerant

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11

12

13

14

0 4 8 12

Ab

solu

te H

b(g

/dl)

Duration of treatment (weeks)Feraccru Placebo

• Phase III study in 128 patients

• A clinically relevant haemoglobin (Hb) increase isconsidered to be 1g/dL

– Feraccru delivered highly relevant and rapid 2.3g/dLrise inside 12 weeks with 1g/dL in only 4 weeks

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P < 0.0001

By wk-12 mean Hb of the treated group had normalised

Long term compliance levels of 97%

With chronic therapy patients’ anaemia did not recurand iron indices continued to improve

Ongoing Feraccru therapy may prevent need for IV iron

Majority of adverse events were related to IBD status

Feraccru-treated patients had fewer adverse events thanplacebo-treated patients

Neither short or long-term Feraccru therapy lead to ironoverload

Source: Marketing Authorisation Application (MAA)

11

12

13

14

0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64

Ab

solu

te H

b (

g/d

l)

Weeks of treatment

Normalisation of males

Normalisation of females

010203040506070

% o

f su

bje

cts

Feraccru Placebo

Feraccru provides rapid and effective results...

…works over the long term

Source: Marketing Authorisation Application (MAA)

…and demonstrates “placebo-like” safety

Source: Marketing Authorisation Application (MAA)

Feraccru has demonstrated efficacy with tolerability comparable to placebo in IBD patients

Feraccru: Market Opportunity£500m+ annual sales targeted in EU10 and US

…addressed with a phased approach

Note: EU 10 denotes Belgium, France, Germany, Greece, Italy, Netherlands, Poland, Romania, Spain, UK.Source: Company estimates

1.1m2.3m

4.3m

8.2m

33.8mGeographic expansion

Indication expansion

EU/USPaediatricIndication

US CKD (1.3m)

US IBD (0.7m)

EU 10 CKD

EU 10 IBD

Global potential patient numbers – all indications…

Medium to longer termNear term addressable market

Total:5.8 million

EU 10 IBD1.1 million

US CKD1.3 million

US IBD0.7 million

EU10 CKD1.2 million

CKD other1.1 million

IBD other0.4 million

Womens’ Health12.5 million

CHF3.8million

Paediatric (all causes)4.9 million

Elderly (all causes)3.6 million

Surgery (PBM)1.1 million

Oncology2.0 million

Total:33.8 million

Initial targetpopulation4.3 million

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Prevalent population with IBD 2.5 million

% ID

A 4

0%

(1

mill

ion

)

% receiving oral iron therapy 31% (310,000)

% receiving IV iron therapy 24% (240,000)

% receiving no iron therapy 45% (450,000)

Market expansion• Dissatisfied patients have access to well

tolerated oral therapy• Increasing capacity in hospital clinics

increases access to untreated patients

2nd line treatment• Feraccru is first option for Ferrous

intolerant patients in treatment guidelines

• Reduces the requirement for IV therapy

Switch & step down• Capacity limits help switch from IV to

Feraccru• Patients can be sent home with Feraccru

to continue treatment of anaemia

Feraccru: Access to full IDA patient poolFeraccru has a significantly greater market potential than current IV therapy

Note (1): GFK market research 2015 25

Feraccru: Pricing StrategyPrice at IV iron levels; health system saves administration cost

Payer research is supportive of Feraccru’s positioning at a price broadly comparable with Ferinject (IV) drug pricing, with significant overall savings to the payers after taking account of total cost

In addition to the drug cost for IV iron there are additional costs associated with administration

– requires hospital administration due to risk of anaphylaxis

Payers have recognised the significant cost of administration

– evidenced by high approved prices for Ferinject vs Venofer

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IV (Ferinject / Injectafer) - Annual estimated treatment cost

--

£1,000

£2,000

£3,000

£4,000

£5,000

Germany2 gms/yr

IBDFerinject

Germany4 gms/yr

CKDFerinject

US2 gms/yr

IBDInjectafer

US4 gms/yr

CKDInjectafer

Drug cost Admin cost

Note (1): Source: Gfk(2): Source: Company estimate

1 2

Feraccru pricing window

-- 1 2 3 4 5 6 7 8 9 10 11 12

Feraccru targetpricing

Ferinject (EU)

Injectafer (US)

Daily price (£)

EU

Broad range in pricing dueto differing amounts usedby patients

US

PT20 pivotal phase IIb study

Results

• Primary endpoint met with a p value of <0.001

• All 4 doses reduced serum phosphate levels

• Data suggests possibility of reduced pill burden in

phase III and of aggressively dosing resistant

patients

• Ferritin score (measurement of iron status) after 2

weeks of IV iron withdrawal suggests PT20 positively

impacts iron levels as well as binding phosphate

– will need to be explored further in phase III

study using suitable endpoints

– if confirmed, will provide additional USP for

PT20 launch

Design

• Conducted in 20 US dialysis centres

• Randomised study of 4 fixed dose levels of PT20 and

placebo

• 153 randomised subjects, study powered >90%

Difference in Ferritin scores after removing IV iron for 14 days

Source: Company Phase IIb results

28 day change in serum phosphate baseline

(60)

(40)

(20)

--

20

40

60

PT20 Placebo

Ferr

itin

ng/

mL

Screening up to 14 days

Washout period up to 28 days

Pre-treatment

up to 7 days

Treatment period 29 days

Follow up 14 days

Stop phosphate-binder Randomise

Start study medication

Complete treatment period

Placebo 400mg tid 800mg tid 1600mg tid 3200mg tid

(2.0)

(1.5)

(1.0)

(0.5)

--

Seru

m p

ho

sph

ate

mg/

dL

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HyperphosphataemiaA significant and growing market opportunity

0

100,000

200,000

300,000

400,000

500,000

1981 1984 1987 1990 1993 1996 1999 2002 2005 2008 2011

Note (1): Run-rate(2): Based on estimates from Decision Resources 2014, with data sourced from US and EU renal registries

$0

$200

$400

$600

$800

$1,000

$1,200

$1,400

$1,600

$1,800

2010 2011 2012 2013 2014R12M*

Fosrenol (Shire) Calcium Acetate Renvela (Sanofi)

Annual US sales of phosphate binding drugs(1)

CAGR (1981 - 2012): 7%

US dialysis patient prevalence 1980-2012

Source: United States Renal Data System (USRDS)

Source: United States Renal Data System (USRDS)

(1)

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Pricing is attractive

• New entrants have achieved broadly comparable pricing to market leading products

• Price will likely play a role in the uptake of PT20 given increasing genericisation of older products

$15,341

$10,235

$12,136 $13,061

$0

$2,000

$4,000

$6,000

$8,000

$10,000

$12,000

$14,000

$16,000

Renvela Fosrenol Velphoro Auryxia

Yearly cost of phosphate binders per patient

PT40 presents an attractive near-term partnering opportunity

Market opportunity

• >£220m Venofer sales in US & Europe1

• FDA has attempted to fast-track the development of generics by issuing Guidance on the studies necessary to register an iron sucrose in America

• No generic Venofer is available, there are iron sucrose similars in some European and Indo-Asian markets, but not recognised as true generics

The challenge

• Ill-defined nature of Venofer’s amorphous iron core and its complex organic shell

• Failure to replicate these precisely results in divergent physicochemical behaviour and consequently disparate clinical profile

• Interactions with FDA have confirmed what would be necessary to seek an ANDA for PT40

1 IMS data 2012

Front left and centre, commercial Venofer® solutions; front right, MRC batch (fully processed/formulated)

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PT40

• The Medical Research Council’s Biomineral Research (BMR) group are experts in the synthesis of nanoparticulate iron oxides

• BMR have developed proprietary in-house assays to characterise Venofer’s complex

• Coupling these techniques with a sequential synthetic approach has led to a highly scaleable and tuneable process suitable for manufacturing a genuine iron sucrose generic to target the US market