Presentación de PowerPoint - Midatech Pharma AGM Presentation 2017.… · The securities of the...

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Corporate Presentation Midatech Pharma plc May 2017

Transcript of Presentación de PowerPoint - Midatech Pharma AGM Presentation 2017.… · The securities of the...

Page 1: Presentación de PowerPoint - Midatech Pharma AGM Presentation 2017.… · The securities of the Company have not been registered under the Securities Act and may not be offered or

Corporate Presentation

Midatech Pharma plcMay 2017

Page 2: Presentación de PowerPoint - Midatech Pharma AGM Presentation 2017.… · The securities of the Company have not been registered under the Securities Act and may not be offered or

Disclaimer

THIS PRESENTATION MAY NOT BE COPIED OR REPRODUCED IN ANY FORM, FURTHER DISTRIBUTED OR PASSED ON, DIRECTLY OR INDIRECTLY, TO ANY OTHER PERSON, OR PUBLISHED, IN WHOLE OR IN PART, FOR ANY PURPOSE. IN PARTICULAR, THIS PRESENTATIONAND ITS CONTENTS ARE NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN OR INTO OR FROM THE UNITED STATES, CANADA, AUSTRALIA, SOUTH AFRICA OR JAPAN OR ANY JURISDICTION WHERE SUCH DISTRIBUTION IS UNLAWFUL. ANY FAILURE TO COMPLYWITH THESE RESTRICTIONS MAY CONSTITUTE A VIOLATION OF APPLICABLE SECURITIES LAWS.

This presentation does not constitute or form part of any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for, any securities of the Company, nor shall it or any part of it nor the fact of its distribution form the basis of, or berelied on in connection with, any contract commitment or investment decision in relation thereto.

The information contained in this presentation has been prepared by Midatech Pharma plc ("Midatech" or the "Company"). It has not been fully verified and is subject to material updating, revision and further amendment. This presentation has not been approvedby an authorised person in accordance with Section 21 of the Financial Services and Markets Act 2000 (“FSMA”) and therefore it is being delivered for information purposes only to a very limited number of persons and companies who are persons who haveprofessional experience in matters relating to investments and who fall within the category of person set out in Article 19 of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) or are high net worth companies within themeaning set out in Article 49 of the Order or are otherwise permitted to receive it. Any other person who receives this presentation should not rely or act upon it. By accepting this presentation and not immediately returning it, the recipient represents andwarrants that they are a person who falls within the above description of persons entitled to receive the presentation. This presentation is not to be disclosed to any other person or used for any other purpose.

Please note that the information in this presentation has yet to be announced or otherwise made public and as such constitutes inside information for the purposes of Article 14 of the Market Abuse Regulation (596/2014/EU) and the Criminal Justice Act 1993. Youshould not therefore deal in any way in the securities of the Company until after the formal release of an announcement by the Company as to do so may result in civil and/or criminal liability.

Panmure Gordon (UK) Limited ("Panmure Gordon") is acting in the provision of corporate finance business to the Company, within the meaning of the Financial Conduct Authority’s Conduct of Business Sourcebook (“COBS”), and no-one else in connection with theproposals contained in this Presentation. Accordingly, recipients should note that Panmure Gordon is neither advising nor treating as a client any other person and will not be responsible to anyone other than the Company for providing the protections afforded toclients of Panmure Gordon under the COBS nor for providing advice in relation to the proposals contained in this presentation.

While the information contained herein has been prepared in good faith, neither the Company nor any of its shareholders, directors, officers, agents, employees or advisers give, have given or have authority to give, any representations or warranties (express orimplied) as to, or in relation to, the accuracy, reliability or completeness of the information in this presentation, or any revision thereof, or of any other written or oral information made or to be made available to any interested party or its advisers (all suchinformation being referred to as “Information”) and liability therefore is expressly disclaimed. Accordingly, neither the Company nor any of its shareholders, directors, officers, agents, employees or advisers take any responsibility for, or will accept any liabilitywhether direct or indirect, express or implied, contractual, tortious, statutory or otherwise, in respect of, the accuracy or completeness of the Information or for any of the opinions contained herein or for any errors, omissions or misstatements or for any loss,howsoever arising, from the use of this presentation. In particular, unless expressly stated otherwise, the financial information contained in this presentation relates to the Company and its subsidiary undertakings. To the extent available, the industry and marketdata contained in this presentation has come from official or third party sources. Third party industry publications, studies and surveys generally state the data contained therein have been obtained from sources believed to be reliable, but that there is noguarantee of the accuracy or completeness of such data. While the Company believes that each of these publications, studies and surveys has been prepared by a reputable source, the Company has not independently verified the data contained therein. In addition,certain of the industry and market data contained in this presentation come from the Company’s internal research and estimates based on the knowledge and experience of the Company’s management in the market in which the Company operates. While theCompany believes that such research and estimates are reasonable and reliable, their underlying methodology and assumptions, have not been verified by any independent source for accuracy or completeness and are subject to change without notice. Accordingly,undue reliance should not be placed on any of the industry or market data contained in this presentation.

Neither the issue of this presentation nor any part of its contents is to be taken as any form of commitment on the part of the Company to proceed with any transaction and the right is reserved to terminate any discussions or negotiations with any prospectiveinvestors. In no circumstances will the Company be responsible for any costs, losses or expenses incurred in connection with any appraisal or investigation of the Company. In furnishing this presentation, the Company does not undertake or agree to any obligationto provide the recipient with access to any additional information or to update this presentation or to correct any inaccuracies in, or omissions from, this presentation which may become apparent.

This presentation should not be considered as the giving of investment advice by the Company or any of its shareholders, directors, officers, agents, employees or advisers. In particular, this presentation does not constitute an offer or invitation to subscribe for orpurchase any securities and neither this presentation nor anything contained herein shall form the basis of any contract or commitment whatsoever. Each party to whom this presentation is made available must make its own independent assessment of theCompany after making such investigations and taking such advice as may be deemed necessary. In particular, any estimates or projections or opinions contained herein necessarily involve significant elements of subjective judgment, analysis and assumptions andeach recipient should satisfy itself in relation to such matters.

This presentation and the information contained herein are not an offer of securities for sale and are not for publication and or distribution in the United States or to any US person (within the meaning of Regulation S under the United States Securities Act of 1933,as amended (the “Securities Act”)) or in Canada, Australia, South Africa or Japan or any jurisdiction where such offer or distribution is unlawful. Any failure to comply with this restriction may constitute a violation of United States securities laws.

The securities of the Company have not been registered under the Securities Act and may not be offered or sold in the United States or to any US person unless the securities are registered under the Securities Act or an exemption therefrom is available.

Certain statements in this presentation may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. In some cases, 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 statementsbecause they involve 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 of activity, performance, or achievements. Any forward-lookingstatements are based on currently available competitive, financial and economic data together with management’s views and assumptions regarding future events and business performance as of the time the statements are made and are subject to risks anduncertainties. We wish to caution you that there are some known and unknown factors that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Referenceshould be made to those documents that Midatech shall file from time to time or announcements that may be made by Midatech in accordance with the London Stock Exchange AIM Rules for Companies (“AIM Rules”), the Disclosure and Transparency Rules(“DTRs”) and the rules and regulations promulgated by the US Securities and Exchange Commission, which contains and identifies other important factors that could cause actual results to differ materially from those contained in any projections or forward-lookingstatements. These forward-looking statements speak only as of the date of this presentation. All subsequent written and oral forward-looking statements by or concerning Midatech are expressly qualified in their entirety by the cautionary statements above. Exceptas may be required under the AIM Rules or the DTRs or by relevant law in the United Kingdom or the United States, Midatech does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future eventsor otherwise arising.

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Page 3: Presentación de PowerPoint - Midatech Pharma AGM Presentation 2017.… · The securities of the Company have not been registered under the Securities Act and may not be offered or

A rapidly growing international specialty pharmaceutical company

UK-based public company (LON: MTPH / Nasdaq: MTP)• >100 employees across Europe and the US

• Diversified strategy and sources of revenue with innovative R&D pipeline

• Highly experienced pharma management team

Established US commercial presence (40 team members)• Six marketed products: potential aggregate peak sales of $50 million

• Double-digit top-line growth expected over the next 12 months

• Plan for lead product Q-Octreotide to be filed for marketing authorisation in 2018

Fully integrated R&D capabilities with two platform technologies• Glycan coated gold nanoparticles (GNP)

• CAD “printed” sustained-release particles (Q-Sphera)

• Drives a novel, low risk development pipeline based on known therapeutic agents

• 3-4 clinical trials planned in 2017

Organisation

CommercialForce

R&D

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Page 4: Presentación de PowerPoint - Midatech Pharma AGM Presentation 2017.… · The securities of the Company have not been registered under the Securities Act and may not be offered or

2016 operational highlights

• Successful integration and strong sales performance from our recently acquired US commercial business• Total revenue for 2016, £9.2m, growth of 510% vs. 2015 (£1.5m)

• Launch of anti-nausea product Zuplenz in the US• Approved for use in multiple indications in a $10bn US market

• Bolsters marketed oncology product portfolio and leverages US commercial infrastructure

• Preparation for final development & commercialisation of Q-Octreotide• Manufacturing scale up in H1 – successful regulatory inspection

and final process validation completed at the Bilbao manufacturing facility

• Good in vivo data achieved

• Planned bioequivalence study to start H1 2017 and filing for first marketing authorisations anticipated by 2018

• Product candidate testing in-vivo for hepatocellular carcinoma (HCC) and glioblastoma (GBM) • Dana Farber testing Midatech’s targeted nanomedicines

against glioblastoma

• Lead product selected for both GBM and HCC programmes

• Dosing commenced in first immunotherapy Phase I study for type I diabetes

• Further positive progress seen in the period in the Company’s OpsiSporin and MTX110/111 (DIPG) programmes

Midatech Pharma continues to executeagainst all key areas of its business model

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*Pro forma revenue for Midatech plus DARA BioSciences, Inc. for 2015 was £4.9m

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Products and commercial platform

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Midatech Pharma US (MTPUS): fully integrated commercial platform

MTPUS commercial operations

• MTPUS has an effective and established commercial platform to sell and market our current oncology supportive care portfolio (6 products)

• 25 representatives with access and established relationships in the highest prescribing oncology markets

• Established through acquisition of DARA BioSciences, Inc. for $24 million and of the complementary product Zuplenz for $3.75 million

MTPUS commercial strategy

• Leverage oncology platform and access to acquire complementary products that enhance portfolio and increase revenues

• Utilise commercial operations to:

• Acquire additional products and launch internally developed pipeline products

• Fund on-going R&D programmes from long-term cash flows

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Page 7: Presentación de PowerPoint - Midatech Pharma AGM Presentation 2017.… · The securities of the Company have not been registered under the Securities Act and may not be offered or

Zuplenz

• Post-chemo radiotherapy anti-nausea and vomiting product

• Acquired for $3.75m (plus back-end milestones based onexcess over forecast sales)

• Expected pay-back time <18 months from point of acquisition

• Entrant into $10bn / 20m prescription per annum US 5HT3 market • 0.25% market share would give sales of $25m/pa

• 0.5% market share would give sales of $50m/pa

• Covered by 11/13 commercial insurers (>250m population)

• Competitive pricing $500/pack (range of competition $250-$1,800)• Superior support and presentation

• Zero patient co-pay program

• May be taken with or without water and dissolves in seconds

• No stickiness from a patch or gritty sensation from a tablet

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Gelclair

• Acquired via DARA BioSciences acquisition

• Indicated for oral mucositis (caused by chemotherapy or radio therapy), with approx. 400,000 annual sufferers in the US• Expansion study starting in 2017

• Lead product in uncompetitive environment (compounded magic mouthwash)

• Covered by 11/13 commercial insurers (>250m population)

• Superior support and mechanism of action vs. magic mouthwash• Zero patient co-pay program

• 3rd year of sales in 2016

• Estimated peak annual sales potential c.$10m

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Page 9: Presentación de PowerPoint - Midatech Pharma AGM Presentation 2017.… · The securities of the Company have not been registered under the Securities Act and may not be offered or

Oravig

• Buccal tablet for treatment of oral “thrush” associated with radio/chemo therapy and in HIV patients

• Launched in October 2015

• Covered by 11/13 commercial insurers (>250m population)

• Over 4m rx written annually for localised treatment

• 0.1% market share = c.$3m annual sales (targeting 0.3%-0.5% market share)

• Superior support and presentation• Zero patient co-pay program

• Once-daily, local treatment

• Does not interrupt eating or drinking

• Revised annual sales potential c.$10m

• Acquired intangible asset has been impaired due to sales performance being below original forecast

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Page 10: Presentación de PowerPoint - Midatech Pharma AGM Presentation 2017.… · The securities of the Company have not been registered under the Securities Act and may not be offered or

Research and development

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CED/DIPG MTX111

Development pipeline: up to 4 programmes entering clinic in 2017

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RESEARCH PRECLINICAL CLINICAL / REGULATORY PHASES

Immunotherapy

Cancer

Ophthalmology

Q-Octreotide carcinoid MTD201

Glioblastoma MTR103

Opsisporin be out-licensed

Liver hepatocellular carcinoma MTR104

Immuno-oncology vaccine MTR

Immuno-oncology TAM MTR

Type 1 diabetes vaccine MTX102

Development of multiple high-value, targeted therapies for major diseases with unmet medical need

DIPG pontine glioma MTX110 named patient basis + clinical trials

Uses gold nanoparticle technology

Uses polymer microsphere technology Uses nano-inclusion technology

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Q-Octreotide (MTD201)

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Currently in final stages pre-clinical development• Formulation complete• Entering bio-equivalence or therapeutic equivalence studies 2017• Planned US marketing submission in 2018/9 followed by launch

Manufactured in house with terminal sterilisation• Saves time (c6 months from CMO)• Investing now in preparation of full commercialisation• Enable other projects using Q-Sphera technology (e.g. Ophthotech), to

capture more value

Peak market potential c$100m p.a.• Own sales targeted in the USA• Centurion out-licence achieved for Turkish rights

Long-acting formulation of Octreotide acetate for chronic treatment of carcinoid (cancer) and acromegaly

Market worth over $2bn (Sandostatin LAR $1.6bn)

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Uses Midatech’s polymerMicrosphere technology

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Q-Octreotide (MTD201)

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Positive pre-clinical data• Compares favourably with Sandostatin

LAR• Pharmacokinetic data correlates well

with PD effects• Injections well tolerated with no site

reactionSteps to commercialisation• Pilot human pharmacokinetic study

planned 2017, followed by bioequivalence or therapeutic equivalence programme in H2 2017

• Marketing authorisation submission anticipated in the period Q4/17 -Q4/18

Advantages• 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

Market entry plan• Product could be commercially available in

2018/19 with (internal) estimated peak sales of $100m

• Representing c5% of $2bn a year market

Uses Midatech’s polymerMicrosphere technology

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DIPG: diffuse interstitial pontine glioma (MTX110)

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Direct administration of Midatech Nanotherapeutics into the tumour through Convection Enhanced Delivery (CED):• Delivers therapeutic constructs via a series of catheters fixed directly into

the substance of the tumours

Ultra-high unmet need, potential orphan indication• No treatment options currently available

Compassionate use/named patient programme: MTX110 • Four patients treated with MTX110 to date UK and US• First patient continues to be infused monthly (10 infusions to date)

Ultra rare childhood brain tumour• c.1,000 cases / year worldwide• Average survival = 7-9 months; universally fatal

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Uses Midatech’s nano-inclusion technology

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DIPG: diffuse interstitial pontine glioma (MTX110)

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Uses Midatech’s nano-inclusion technology

Research & Development next steps:• Regulatory interactions throughout

2017 – high level of support for program by regulatory agencies

• MTX110: planning for main US and EU studies at advanced stage –estimated start H2 2017

• MTX111: follow-on programme

MTX 111• Other DIPG constructs in R&D:

Maytansinoids (AT), Doxorubicin (TPI2), Irinotecan (TPI1), HDACi’s

Market entry plan• FDA study requirement TBC• File for pivotal study in Europe• Product could be commercially

available in 2018• Market entry plan via specialist

centres in USA/EU/RoW – c5 in each geography

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Targeted maytansinoid for HCC (MTR104)

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Currently in pre-IND development• Particle construction & targeting complete• Two step targeting – passive to liver and active to tumour cell receptors• Plan to file for FIH study in Q4 2017

Significant progress to date• Manufacturing scale up underway to GMP• Orphan Designation applied for • Clear dose responses• Very significant tumour reduction seen at 450μg/kg

Peak market potential >$500m p.a.• Co-promote / Midatech own sales force in the USA• Global partner sought to co-develop this program

Compelling data to date shows animals thrive on targeted chemo, at a level of dose (450μg/kg) that is lethal without the targeting

Market worth over $1.5bn by 2019• Sorafenib only current approved product but too toxic for most patients

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Uses Midatech’s gold nanoparticle technology

Tumour Volume following dosing with DM1-GNP, DM1, and vehicle only controls

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MTR104 – No effects off-target demonstrated…

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Uses Midatech’s gold nanoparticle technology

MTR104 candidate tolerability

Page 18: Presentación de PowerPoint - Midatech Pharma AGM Presentation 2017.… · The securities of the Company have not been registered under the Securities Act and may not be offered or

2016 financials

Page 19: Presentación de PowerPoint - Midatech Pharma AGM Presentation 2017.… · The securities of the Company have not been registered under the Securities Act and may not be offered or

2016 financial highlights

• Total gross revenues for the year up 510% to £9.21m (2015: 844% to £1.51m)

• Statutory revenue for the year up 718% to £6.38m (2015: 2,500% to £0.78m)

• £17.61m cash and deposits at 31 December 2016 (2015: £16.18m)

• Net loss after tax of £20.16m (2015: £10.10m) with net cash inflow in the year of £0.97m (2015: £14.17m outflow)

• Tax credit receivable of £1.44m (2015: £1.20m)

• Entered into a senior secured £6 million loan agreement with Silicon Valley Bank in Q1 2017

• October 2016 Gross £16.7m Equity Raise completed in London

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Consolidated income statement

(audited) Year ended 31 Dec 2016

Year ended31 Dec 2015

£'000 £'000

Gross revenue 8,659 914Grant revenue 547 600

_______ ________Total revenue 9,206 1,514

_______ ________

Total net revenue 6,923 1,375

Cost of sales (667) (70)_______ ________

Gross profit 6,256 1,305

Research and development costs (6,684) (5,920)Distribution costs, sales and marketing (9,523) (374)Administrative costs (9,222) (7,929)Impairment of intangible asset (11,413) -

_______ ________Loss from operations (30,586) (12,918)

Finance income 1,337 1,691Finance expense (73) (5)

_______ ________

Loss before tax (29,322) (11,232)

Taxation 9,160 1,133_______ ________

Loss after tax attributable to the owners of the parent (20,162) (10,099)________ ________

Loss per share Basic and diluted loss per ordinary share – pence (56p) (36p)

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(audited) As at31 Dec 2016

As at31 Dec 2015

£’000 £’000Non-current assetsProperty, plant and equipment 2,766 1,984Intangible assets 31,172 41,339Other receivables due in greater than one year 448 425

_______ _______

34,386 43,710_______ _______

Current assetsInventories 817 459Trade and other receivables 2,439 2,496Taxation 1,439 1,201Cash and cash equivalents 17,608 16,175

_______ _______

22,303 20,331_______ _______

Total assets 56,689 64,041_______ _______

Non-current liabilitiesBorrowings 1,620 1,508Deferred tax liability - 6,547

_______ _______

1,620 8,055_______ _______

Current liabilitiesTrade and other payables 8,407 7,084Borrowings 538 442Derivative financial liability – equity settled 400 1,573

_______ _______

9,345 9,099_______ _______

Total liabilities 10,965 17,154_______ _______

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Consolidated balance sheet

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Consolidated cash flow statement

(audited) Year ended 31 Dec 2016

Year ended31 Dec 2015

£’000 £’000

Cash used in operations (14,736) (13,067)

Taxes received 1,650 646_______ _______

Net cash used in operating activities (13,086) (12,421)_______ _______

Investing activitiesPurchases of property, plant and equipment (1,347) (922)Purchase of intangibles (19) (3)Acquisition of subsidiary, net of cash acquired - 1,867Acquisition of business - (2,528)Interest received 164 53

_______ _______Net cash used in investing activities (1,202) (1,533)

Financing activitiesInterest paid (74) (5)Payments to finance lease creditors (69) (49)Repayment of borrowings (235) (165)Issue of borrowings 65 -Loan finance raised - -Share issues net of costs 15,568 -

_______ _______Net cash (used in)/generated from financing activities 15,255 (219)

Net (decrease)/increase in cash and cash equivalents 967 (14,173)

Cash and cash equivalents at beginning of year 16,175 30,325

Exchange gains on cash and cash equivalents 466 23_______ _______

Cash and cash equivalents at end of year 17,608 16,175_______ _______

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2017 possible news flow

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• Q-Octreotide human bio-equivalence studies to commence in Q2-Q3

• Further updates on brain tumour cancer therapy programme (DIPG) for compassionate use patients

• Lead candidate selected for HCC - orphan status and possible IND submission

• Further preclinical data across multiple programmes

• Licensing of Bilbao facility to GMP manufacture Q-Sphera based products like Q-Octreo

• Expansion (Ph4) study for Gelclair in bone marrow transplant in USA

• Filing for potential pivotal studies in the USA and Europe for MTX110

Page 24: Presentación de PowerPoint - Midatech Pharma AGM Presentation 2017.… · The securities of the Company have not been registered under the Securities Act and may not be offered or

Summary

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On-track for execution of three-pronged strategy for growth and value creation• Continue to invest in products and technology to drive value for stakeholders in the business• Developing novel pre-clinical and clinical portfolio pipeline• Seeking attractive acquisition targets, products and technology• Strong cash position to drive towards profitability

Leading proprietary platform technologies

• Gold nanoparticles• Sustained-release delivery• Targeted delivery and release of existing therapeutics to the “right place” at the “right time”

Midatech Pharma an international specialty pharma company• Focused on development and commercialisation of multiple high-value, targeted therapies for

major diseases with unmet medical needs• US commercial arm has six products in oncology treatment and supportive care, driving revenue

growth• Own product launches from 2018-19 at high margin

Photograph of section through needle showing microspheres

Representation of a gold nanoparticle