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MIDATECH 2015 ANNUAL RESULTS APRIL 2016

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Page 1: MIDATECH 2015 ANNUAL RESULTSmidatechpharma.com/uploads/investor_files...Zuplenz (ondansetron) is a highly effective 5HT3 antagonist approved as an anti-emetic by the ... • Non-patch

MIDATECH 2015 ANNUAL RESULTSAPRIL 2016

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Disclaimer

Certain statements in this presentation may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such forward-lookingstatements include, but are not limited to, statements regarding the expected completion of the acquisition, any expected free cash flow generation, any expected NASDAQ listing, anymarket and growth opportunities, the amount of anticipated cost synergies and other benefits associated with the acquisition and other statements that are not historical fact. In somecases, you can identify forward-looking statements by the use of words such as “may,” “could,” “expect,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “potential,” “estimate,”“predict,” “potential,” or “continue” or the negative of these terms or other comparable terminology. You should not place undue reliance on forward-looking statements because theyinvolve known and unknown risks, uncertainties and other factors that are, in some cases, beyond our control and that could materially affect actual results, the acquisition, levels ofactivity, performance, or achievements.

Any forward-looking statements are based on currently available competitive, financial and economic data together with management’s views and assumptions regarding future eventsand business performance as of the time the statements are made and are subject to risks and uncertainties. We wish to caution you that there are some known and unknown factorsthat could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements, including but notlimited to uncertainties as to how DARA stockholders may vote in respect to the merger proposal, the possibility that competing offers may be made, the possibility that various closingconditions for the Acquisition may not be satisfied or waived, operational challenges in achieving strategic objectives and executing plans, the risk that markets do not evolve asanticipated, the potential impact of the general economic conditions and competition in the industry. The risks included are not exhaustive.

Reference should be made to those documents that Midatech and DARA shall file from time to time or announcements that may be made by Midatech and/or DARA, in the case ofMidatech, in accordance with the London Stock Exchange AIM Rules for Companies (“AIM Rules”) and the Disclosure and Transparency Rules (“DTRs”) and in the case of DARA the USSecurities and Exchange Commission (“SEC”), including the section titled “Risk Factors” of DARA’s most recent Annual Report filed on Form 10-K and Quarterly Reports on Form 10-Q. Thisis in addition to the proxy statement/prospectus to be filed by Midatech and DARA, which shall contain and identify other important factors that could cause actual results to differmaterially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequentwritten and oral forward-looking statements by or concerning Midatech or DARA are expressly qualified in their entirety by the cautionary statements above. Except as may be requiredunder the AIM Rules or the DTRs or by relevant law in the UK or the US, Midatech and DARA do not undertake any obligation to publicly update or revise any forward-looking statementsbecause of new information, future events or otherwise arising.

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A Rapidly Growing International Specialty Pharmaceutical Company

Organisation

Technology

Organisation

CommercialForce

Technology

UK-based public company (plc)• IPO on London’s AIM (MTPH) raising £32 million in 2014• ADRs listed on NASDAQ (as MTP) in Dec 2015• c.100 employees across Europe & the USA • Multiple acquisitions driving fast revenue growth• £16.2m / $24m cash as of December 31st 2015

Oncology / US Commercial Team (40)• 6 fast-growth marketed products • Including 1 mature product in US• Multiple topline growth expected in 2016 vs 2015

Fully integrated R&D capabilities with two platform technologies• Full R&D capability• Glycan coated gold nanoparticles• CAD “printed” sustained release particles

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Using Midatech Technologies

Oncology / Neuroscience/Diabetes

Late Stage

Strategic & Synergistic Assets

Orphan Oncology/ Immunotherapy

Neuro / Ophthalmology

Partners

CommercialOncology & Supportive Care (US)

Acquisitions

Research & Development

Our Approach – Business Model

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Acquired Dara Biosciences, an oncology supportive care pharmaceutical company

• Adds an attractive portfolio of cancer supportive care products

• Establishes fully integrated US-based commercial organisation (Midatech Pharma US)

2015 Highlights

In 2015 Midatech executed against all key areas of its business model

Established two research collaborations that expanded pipeline• Dana Farber to test Midatech’s targeted nanomedicines against glioblastoma

• Ophthotech Corporation to explore opportunities in ocular indications

Acquired Zuplenz (ondansetron), a marketed anti-emetic approved in the US• Approved for use in multiple indications and recently launched into the $10bn US market

• Bolsters marketed oncology product portfolio

Established supply agreement for Q-Octreotide signed with Centurion Pharma• Focused on development and commercialisation of products in Turkish market

Commencement of Phase IIa study of Midaform Insulin Type 1 Diabetes Program• Small trial to establish PK/PD profile of MSL-001

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Total revenue for the year up 763% to £1.38m (2014: £0.16m, 2013: £0.15m)

£16.18m cash and deposits at 31 December 2015 (2014: £30.33m, 2013: £2.39m)

Net loss after tax of £11.74m (2014: £8.82m, 2013: £4.08m)

Net cash outflow in the year of £14.17m (2014: £27.94m inflow, 2013: £2.25m inflow)

Tax credit receivable of £1.20m (2014: £0.84m, 2013: £0.80m)

2015 Financial Highlights

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Terms of the deal

• Issue of 5,422,028 Midatech ordinary shares valued at £14.43m

in the form of American Depositary Receipts ("ADRs“)

• The ADRs were admitted to trading on the NASDAQ Stock

Market LLC trading platform on 4 December 2015

• Additional consideration was paid in the form of a

preference share settlement and the assumption

of share options and warrants

• Adds NASDAQ listing and headquarters in Raleigh, NC

• Merger establishes Midatech Pharma’s US-based commercial

arm

• Products focused on oncology and supportive care

• Portfolio of six approved products

• US field organisation of 32

• Provides platform for additional product license and acquisition

opportunities

Acquired DARA BioSciences in June 2015

National Coverage

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DARA Brings a Portfolio of US Marketed Products

Comprehensive offering of oral supportive care products for cancer patients

Buccal Tablet For Oral Candidiasis In Adults

Serious complication for patients undergoing radio/chemotherapy

Launched H2 2015 – first full year of sales 2016

Hyaluronic Acid Oral Gel For Oral Mucositis

85-100% of H&N cancer patients on chemo/radiotherapy develop OM

Leads market in US strong growth expected 2016

Dual Iron Delivery

Anaemia treatment

Oral Spray Treatment For Dry Mouth

Xerostomia

The only liquid oral tamoxifen available in the US

Breast Cancer

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Acquired Zuplenz (ondansetron) in December 2015

Product launched by Midatech on April 11TH

• Will be sold through Midatech Pharma US• Product will be first position product detailed by 32 sales reps

Zuplenz (ondansetron) is a highly effective 5HT3 antagonist approved as an anti-emetic by the US Food & Drug Administration (FDA)

Product is an oral soluble transmucosal film approved for the prevention of:• Chemotherapy-induced nausea and vomiting (CINV)• Radiotherapy-induced nausea and vomiting (RINV)• Post-operative nausea and vomiting (PONV)

Favourable delivery profile to currently marketed products• No injection needed• Non-gritty delivery mechanism• Non-patch delivery

Patent protected up to 2029 provides a long-duration asset for Midatech

• Discreet on-the-go usage• Removal of the burden of swallowing pills during emesis• No sedative side effects

Midatech paid to Galena Biopharma a total of $3.75 million in cash• Potential for additional payments of up to $26 million if sales milestones are achieved

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Diabetes: Treatment For Type 1 Diabetes (T1D)

• Self-dissolving, oral, postage stamp-sized strip containing GNP conjugated insulin

•More convenient, safer and more discrete form of insulin delivery than injections• Enhanced patient compliance, and easy to use•No lipohypertrophy

MidaSol (JV with MonoSol, USA)

• Phase I (2012) ‐ No safety concerns‐ Suggests insulin enters blood, faster to max effect

• Phase IIa ‐ Completed in life phase January 2016‐ Clinical Study Report is expected in April/May 2016

• Phase II data will inform strategic opportunities (license or exit)

MidaForm Insulin PharmFilm® – GNP buccal insulin therapy for needle-free delivery of insulin for diabetes treatment

+

+

+

+ Au

(Driven by osmotic pressure)

(Slow-disolving)

(Fast-disolving)

Transbuccal insulin

Outer inactive strip

Buccal mucosa

Inner active strip containing GNPs

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Carcinoid & Acromegaly: Octreotide - Long-Acting Drug Delivery

Once-monthly injectable depot with lower CoGs

Market worth over $2bn

(Sandostatin LAR $1.5bn)

Significantly easier to reconstitute and

administer than current Sandostatin product

• Seconds to reconstitute vs 35 minutes

• In home administration with patient

friendly device vs. current administration

in clinic via IV

• Smaller needle

• Can reduce clinical visit time by more

than half

Long-acting formulation of Octreotide

acetate for chronic treatment of

Acromegaly/Cancer

Currently in final stages preclinical development

• Entering bio-equivalance studies in 2016/7

• Planned US Launch in 2018/9

• Sales by our own team

• Peak market potential in USA c$100m pa

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Key post approval activities (where needed) : Reimbursement submissions; Promotional material submission/approval; Notification of launch

Q1

17

Phase1/Bioequivalent study

CTA application for TE study

Q2

17

Manufacture of Clinical Trial Material

TE study

Manufacture of Registration batches

Eligibility for Centralised Procedure

Suitability of Tradename

NDA/MAA preparation

NDA/MAA Review

Q3

17

Q4

17Q1

18

Q2

18

Q3

18

Q4

18

Q1

19

Q2

19

Q3

19

Q4

19

Estimated Timeline & Key Milestones to Commercial Launch

Single Dose BE/PK

Earliest

date

Earliest

date

Latest

date

Latest

date

BIOEQUIVALENCE

ROUTE

THERAPEUTIC

EQUIVALENCE ROUTE

Multi Dose BE

12

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Integrin α6 Receptor

• Over-expressed poorly-differentiated GBM

• Binds laminin in extracellular matrix

• GNP synthetic peptide sequences used as ligands for receptor

CXCR4

• Over-expressed in differentiated GBM tissue

• Important in neovascularisation, blockade reduces invasiveness and growth

• Multiple targeting possibilities (small molecule, recombinant peptide, synthetic peptide, monoclonal antibody)

S i g n e d C o l l a b o rat i v e D e a l w i t h D a n a - Fa r b e r C a n c e r I n s t i t u t e I n A p r i l 2 0 1 5

G B M : G l i o b l a sto m a

Candidate selection ongoing, and IND enabling planned to commence end 2016

Dana-Farber is the principal teaching Institute of Harvard Medical School in Boston, MA and one of the premier cancer institutes in the US

Worldwide, there are an estimated 240,000 cases of brain and nervous system tumours per year• GBM is the most common, and the most lethal, of these tumours

Survival typically 12 to 15 months with less than 5% surviving longer than five years

Receptors on GBM tumour cells bind and internalise GNPs where the therapeutic payload is released

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Ophthotech (Nasdaq: OPHT) is a biopharma company specialising in treating diseases of the back of the eye

Collaboration will test the feasibility of using Midatech’s Q Sphera microencapsulation technology

for sustained delivery of select Ophthotech products

Q Sphera uses inkjet printing technology to produce monodisperse microparticles

• Flow process: tanks of ink replaced by drug & polymer

• Microparticles are homogeneous and degrade in a predictable and tuneable fashion

• Compatible with small molecules, peptides, oligonucleotides and small proteins

• Easily scalable printing ‘000,000 particles per second

Signed Collaborative Deal with Ophthotech in August 2015

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0

20

40

60

80

0 7 14 21 28 35 42 49 56 63 70 77 84 91 98105112119126133

CsA

Rele

as

e / μ

g/m

g

Time / Days

Cyclosporine in vitro Release (P.B.S. receptor solution)

Intravitreal injection via 27-30G needle directly to vitreous and posterior eye, with minimal transfer to the blood

Preclinical in 2016

Uveitis growing rapidly ~$1.3bn market, current

treated by eyedrops, immuno-suppresives or

systemic

Successful PoC completed in

several animal models

OpsiSporin is 3-monthly injectable formulation of

cyclosporine for treatment of non-

infective uveitis

Product will be steroid and immunosuppressant sparing

Delivered intravitreal at 1000 fold lower doses than oral cyclosporine

Currently no approved intravitreal cyclosporine or other immunosuppressant treatment option available

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Uveitis: OpsiSporin - Long-Acting Drug Delivery

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Research Preclinical Phase I Phase II Market $

> $ .64 bn

> $ 2 bn

> $ .5 bn

> $ .5 bn

> $ 20 bnMidaform® Insulin (JV MonoSol) MTD101

Joint Venture Product

ImmunotherapyType 1 Diabetes Vaccine MTX102

Cancer

OpsiSporin MTD202

CNS/Ocular

DIPG Pontine Glioma MTX110 Experimental Use NPS Program Underway

Q-Octreotide MTD201

Glioblastoma MTR103

Liver Hepatocellular Carcinoma MTR104

Development Pipeline

Squamous Cell Carcinoma MTR105

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01

02

03

04

05

Dosing commenced 29/02/2016 (NPS)• Compassionate use request received from Bristol Royal

Infirmary Oncology to treat young girl suffering from DIPG

• Midatech formulated drug for administration via CED (in 3 months)

• Patient doing well post dosing, and additional patients planned

Ultra rare childhood tumour300 cases / year, no survivors

Ultrahigh unmet need

Opportunity to earn revenue prior to registration

Could result in a fast tracked product to market for Midatech

DIPG: Diffuse Interstitial Pontine Glioma (MTX110)

Midatech actively pursuing local delivery directly into the tumour

through Convection Enhanced Delivery (CED) that delivers

therapeutic constructs directly into the tumour via a series of catheters fixed

into the substance of the tumours

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Executing on Strategic Objectives to 2019

To have acquired at least 2 other value enhancing businesses Q-Chip in 2014 DARA BioSciences – Dec 2015Zuplenz (product) – Dec 2015

Established and continue to expand US commercial presence

Establish EU commercial organisation

To have >2 products licensed to partners • 1 to date

To have >1 own product marketed • Q-Octreo on course

To be breaking-even

To be growing top-line revenue each year by minimum 50% • Estimate for 2015 Vs 2014 = 700% Growth• Market expectation 2016 Vs 2015 = 700% Growth

To be recognised as a leading emerging specialty pharma company globally

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2016 Expected News Flow

Zuplenz: US commercial launch in H1

Gelclair: Maintenance of growth & leadership position in US market

Oravig: First full year of sales in US post launch in Q4 2015

First brain tumour cancer therapy into patients H1

First immunotherapy vaccine in clinical trials in H1

Joint venture insulin Phase IIaresults H1

AGM in MayFurther deployment of core technologies via licensing deals to new & existing partners increasing revenue

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Income Statement for the year ended 31 December 20152015 2014 2013

£’000 £'000 £'000

Revenue 775 25 147

Grant revenue 600 132 -_________ _________ _________

Total revenue 1,375 157 147

Cost of sales (70) - -_________ _________ _________

Gross profit 1,305 157 147

Research and development costs (5,920) (5,439) (1,925)

Distribution costs, sales and marketing (374) - -

Administrative costs (7,929) (4,405) (2,721)_________ _______ _______

Loss from operations before listing and acquisition expenses (9,927) (8,752) (4,499)

Listing and acquisition expenses included in administrative costs(2,991) (935) -

Loss from operations (12,918) (9,687) (4,499)

Finance income 1,691 8 1

Finance expense (5) (161) (385)_________ _______ _______

Loss before tax (11,232) (9,840) (4,883)

Taxation 1,133 1,018 799________ _______ _______

Loss after tax attributable to the owners of the parent (10,099) (8,822) (4,084)________ _______ _______

Loss per share

Basic and diluted loss per ordinary share - pence (36p) (98p) (71p)________ _______ _______

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Audited Financials – Consolidated Balance Sheet2015 2014 2013

£’000 £’000 £'000

Non-current assets

Property, plant and equipment 1,984 1,516 684

Intangible assets 41,339 13,094 4

Investment in equity accounted joint venture - - 12

Other receivables due in greater than one year 387 425 379_______ _______ _______

43,710 15,035 1,079_______ _______ _______

Current assets

Inventories 459 - -

Trade and other receivables 2,496 462 909

Taxation 1,201 841 799

Cash and cash equivalents 16,175 30,325 2,387_______ _______ _______

20,331 31,628 4,095_______ _______ _______

Total assets 64,041 46,663 5,174_______ _______ _______

Non-current liabilities

Borrowings 1,508 1,488 2,119

Deferred tax liability 6,547 354 -_______ _______ _______

8,055 1,842 2,119_______ _______ _______

Current liabilities

Trade and other payables 7,084 2,341 1,047

Borrowings 442 491 1,248

Derivative financial liability – equity settled 1,573 - -_______ _______ _______

9,099 2,832 2,295_______ _______ _______

Total liabilities 17,154 4,674 4,414_______ _______ _______

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Cash Flow Statement for the year ended 31 December 20152015 2014 2013

£’000 £’000 £'000

Cash used in operations (13,067) (6,249) (5,024)

Taxes received 646 794 588

_______ _______ _______

Net cash used in operating activities (12,421) (5,455) (4,436)

_______ _______ _______

Investing activities

Purchases of property, plant and equipment (922) (1,030) (47)

Purchase of intangibles (3) - (3)

Acquisition of subsidiary, net of cash acquired 1,867 115 -

Acquisition of business, net of cash acquired (2,528) - -

Interest received 53 8 -

_______ _______ _______

Net cash used in investing activities (1,533) (907) (50)

Financing activities

Interest paid (5) (48) (15)

Payments to finance lease creditors (49) (48) (93)

Repayment of borrowings (165) (346) (200)

Issue of convertible debt - - 1,251

Loan finance raised - 890 -

Share issues net of costs - 33,852 5,797

_______ _______ _______

Net cash (used in)/generated from financing activities (219) 34,300 6,740

Net (decrease)/increase in cash and cash equivalents (14,173) 27,938 2,254

Cash and cash equivalents at beginning of year 30,325 2,387 133

Exchange gains on cash and cash equivalents 23 - -

_______ _______ _______

Cash and cash equivalents at end of year 16,175 30,325 2,387

_______ _______ ________

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Summary

Leading Platform Technologies

• GNP Technology

• Sustained Release

• US commercial arm has 4 products in oncology, driving fast revenue growth

• Own product launches from 2018-19 at high margin

Midatech Pharma

An International Specialty Pharma Company

• Driving revenue growth

• Developing clinical portfolio

• Seeking attractive acquisition targets

On-track Execution Of Three-Pronged

Strategy For Growth And Value Creation

Photograph of section through needle showing microspheres

Representation of a gold nanoparticle

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Thank You