midatech pharma corporate overvie · the company (the “offering”). the information in the...

Midatech Pharma

Corporate Overview

July 2020

Disclaimer

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MIDATECH PHARMA CORPORATE OVERVIEW 2


Improving the Biodelivery and Biodistribution of Medicines

Drug delivery biotechnology company with disruptive proprietary micro and nano technology platforms

Rapid R&D innovation core to success, delivering First-in-Class sustained/ modified release therapeutics

Dual-listed on LSE AIM: MTPH and NASDAQ: MTP

Headquarters, R&D, non-GMP pilot scale manufacturing in Cardiff, UK

Approximately 20 employees

Corporate Overview

MidaSolve™

MidaCore™Q-Sphera™


2000

Establishment

• Company formed, acquired GNP

technology from CSIC, Madrid

2014

IPO

• IPO on AIM market, London

• Acquired Q-Chip, Q-Sphera

technology

Public Listing

• Listing on NASDAQ

• Acquired DARA Biosciences,

renamed MPUS

2018

2019

Growth

• Sale of MPUS

• MTD201 ‘101 trial reports

Growth

• MTX110 receives orphan status

2020

Realignment

• MTD201 ‘102 trial reports

• Strategic Review

2015

Midatech History and Milestones

Technology

that improves bio-delivery

& bio-distribution on several levels:


Targeted Delivery

• Ultra-small size

• Can bind multiple

agents: Targeting,

Therapeutic

Local Delivery

• Converts oral meds into

liquid meds

• Increases routes of

administration

• Enables direct tumor

injection

Sustained Delivery

• Precision Clinical

performance

• Advanced technology

manufacturing

• Distinct competitive

advantage

Q-Sphera™ MidaSolve™ MidaCore™

• Optimizing clinical solutions

• Improving health economics

• Ongoing clinical programmes

• Reducing production cost

• Opportunities to extend life

cycles of maturing drugs

Industry Leading Technology


Q-Sphera™

Next Generation Microsphere Technology for

Sustained Release Applications

Next Generation Microsphere Technology


Sustained Release Polymer microsphere

Precision particle sizePredictable release kinetics

(from 1 to 6 months)

Technology

•Micro-encapsulation PLGA polymer depot system

•Advanced piezo printing technology

•Several million microspheres produced per second

Clinical

•Extended dosing intervals from days/hours to months

• Improved usability, patient experience & compliance

•Enhanced dosing and administration routes

Production

•Scalable, efficient high yield manufacturing

•Modest infrastructure, environmentally friendly

•Low CoGS and broad API compatibility

Q-SpheraTM

• Adapted for microsphere manufacture with

controlled solvent exchange

• Piezoelectric droplet ejection from MicroDrop

dispenser head with internal diameter 30/70 μm

• Droplet ejection frequency 6 kHz enabling

laboratory scale production of 10-250 mg mass of

dried, solid microparticles

• Scale-up manufacturing blueprint established


3D Pharmaceutical Printing Process:

Unique 3D Microsphere Printing

Q-SpheraTM

MicroDrop Diagram

Proteins, MAbs, FAbs, evaluated on case by case basis

Typically a maximum drug loading (drug:polymer) ~ 25% w/w

Vastly superior homogeneity vs traditional PLGA manufacturing

Small molecule to large peptide – experience up to 50aa

APIs


Mean 26.3 54.8

St. Dev 2.4 12.1

% CV 9.2 22.0

Dimensions/Variability

Q-Sphera™ Sandostatin® LAR

Flexible, Monodispersed Formulation Capabilities

Looking at the ScienceQ-SpheraTM


Pharmacokinetics Favourable Release Kinetics and Less Variability

Needle Size Smaller and Less Painful

• Small 21G needle for MTD201, whereas SLAR uses

19G needle – 40% smaller surface area

• Lower injection pain (8% vs. 25%) and lower injection

site tenderness (8% vs 83%) (MTD201-101)

Reconstitution Time Quicker; and Stability Longer

• MTD201 Reconstitution from opening pack to injection in

under 10 minutes, stable for 2 hrs

• SLAR reconstitution around 40 minutes by the published

method, must be used immediately

Administration Similar plasma octreotide SC and IM injection

MTD201 Compelling Advantages

Q-SpheraTM


Significant clinical and commercial opportunity for longer acting mAbs/proteins

Unique Possibility of Creating Long Acting proteins / mAbs

Emulsion-based manufacture:

Q Sphera™ manufactured microspheres:

• Localisation of encapsulated protein within unavoidable voids; polymer hydrolysis induces acidic

environment and loss of activity of protein/mAb

• Microsphere production process exposes protein to substantial surface area of liquid-liquid

(water or solvent) interfaces, high shear and heat, all of which contribute to API degradation

• Surfactants and solvents used are toxic to proteins

• Homogeneous structure and no voids allows even API distribution

• Open polymer microstructure permits easy fluid ingress and egress

• No surfactants, toxic solvents, biphasic mixtures, shear or heat forces

• Enables the preservation of therapeutic activity beyond processing

Q-SpheraTM


MidaSolve™

Solubilising Insoluble Drugs For Direct-to-Tumour

Administration


Local Delivery Nano inclusion

Solubilises otherwise insoluble drugsIncreases routes of administration direct

to tumour administration

Technology

•Solubilises inherently insoluble drugs

•Nano inclusion technology for chemotherapeutics

•Complex of hydrophobic core and hydrophilic surface

Clinical

•Converts oral drugs into liquid administration forms

•Enables infusion directly into the tumour

•Aim to enhance efficacy and reduce toxicity

Production

•Simple manufacturing process

•No solvents, non-toxic

•Lyophilized powder, long shelf-life

Solubilizing Insoluble DrugsMidaSolveTM


Childhood tumour market size $0.5bn;

Adult GBM market size $3bn - $5bn

No effective

treatments (more

than 200 clinical

trials), drugs cannot

cross blood-brain

barrier.

• Median survival of children with DIPG is 9 months and remains

unchanged despite decades of clinical research.

• $100 million market opportunity

• Medullobastoma (similar epidemiology) is initially treated with surgery

and radiation or chemotherapy, with no standard of care for recurrent

disease.

MTX110: Market Opportunity in Childhood Brian CancersMidaSolveTM

TreatmentGlioblastoma (GBM)Diffuse Intrinsic Pontine Glioma (DIPG)

• Worldwide there are 1,000 patients suffering from DIPG

ultra-orphan disease, a highly infiltrative brainstem high

grade glioma.


1Q20 2Q20 3Q20 4Q20 1H21 2H21 1H22 2H22

DIPG Tolerability UCSF

Medulloblastoma

Exploratory

University

of Texas

DIPG Exploratory Columbia

DIPG Efficacy Zurich

Other eg GBM N/A

Phase I

Phase I

Phase I

Phase II

Pre-Clinical

MTX110: Clinical Programme, Multiple PossibilitiesMidaSolveTM

Competitive Advantage in Establishing a New Treatment Paradigm

• MTX110 received orphan status in the US in 2019

• Combined Phase I / II study underway with children

suffering from DIPG and medulloblastoma

• Panobinostat demonstrated pre-clinically as a most potent

agent against human DIPG cells

• Increases available routes of administration via liquid form


MidaCore™

Working at the Nanoscale


Targeted deliveryGold nanoparticle

Ultra-small sizeCan bind multiple agents

(targeting and therapeutic)

Technology

•Gold nanotechnology to deliver chemo / immuno therapeutics

•Key attributes are small size and multi-functional valency

•Decorated with therapeutic + targeting moieties

Clinical

•Size 2-4nm improves delivery, targeting, reduces toxicity

•Enhanced uptake into cancer cells and cells of the immune system controlling responses to disease

•Research programmes in psoriasis and solid tumours

Production

•Bio-inert and non-toxic

Working At The NanoscaleMidaCoreTM

18|

• Skin thickening significantly reduced with MTX-GNP – significantly greater effect than Daivobet

(calcipotriol/betamethasone dipropionate)

• Confirmed imiquimod-induced psoriasis mouse model results

MTX114: GNP Normalises Skin In Xenotransplant Mouse ModelMidaCoreTM

Daivobet(standard of care) MTX-GNPVaseline


Strategy: Partnerships to Create Value

• Licensing of pipeline products

• Technology partnerships


Business Development: Dual Strategy for Success

Develop in-house enhanced formulations of existing APIs in orphan/specialty

indications to create valueStrategy 1:

Strategy 2: Fee-for-service, third party proprietary APIs

Partner underwrites clinical programme / scale-up.

Midatech receives milestones / royalties.

API Selection

FormulationAnalytics/characteri

zationIn virto

dissolution

Optimization/Manufacture

PoCIn vivo

Partnering/tech transfer

---1 month --- ------------------------------------------------ 3 months ----------------------------------------------- -- 3 months --


2019 (£m) 2018 (£m)

Revenue 0.7 1.9

R&D (7.8) (9.4)

Distribution (0.3) -

Administrative (3.8) (4.4)

Loss from operations 11.3 11.8

Loss before tax 10.9 12.4

Cash at 31 December 10.9 2.3

• Revenues approx. 50% grant, 50% fees

• R&D includes:

• £4.3m MTD201

• £1.5m MTX110; and

• Full year of Bilbao costs

• Administrative includes:

• £1.6m personnel costs

• £1.3m professional fees

• Cash on hand offset by £4.9m soft loans

• Current cash runway through to 2Q21

Financial – Year Ended 31 December 2019


Multiple applications:

Robust IP portfolio:

Licensing strategy:

Modest cash burn:

Summary

Improving bio-delivery and bio-availability of approved and unapproved drugs

All technologies into humans, Lead programs in clinic, technologies validated, defined development paths

First-in-class SR applications, marketed and development compounds, all therapeutic areas

Clinically validated technology:

Superior drug delivery platforms:

36 patent families with 107 issued patents covering core technology platforms

Feasibility to pre-clinical in-house; partner before clinical

£0.4m per month, cash runway to 2Q21

Thank You.


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