In Interim Results ts 2016 - September 2016 Midatech Pharma plc - - PowerPoint PPT Presentation
In Interim Results ts 2016 - September 2016 Midatech Pharma plc - - PowerPoint PPT Presentation
In Interim Results ts 2016 - September 2016 Midatech Pharma plc 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
Disclaimer
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- uncertainties. 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. Reference
should 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-looking
- statements. 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. Except
as 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 events
- r otherwise arising.
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A Rapidly Growing International Specialty Pharmaceutical Company
UK-based public company (plc)
- c.100 employees across Europe & 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
- Expect lead product Q-Octreotide to be filed for marketing authorisation by end 2017/beginning of 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, lower risk development pipeline based on known therapeutic agents
Organisation Commercial Force R&D
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2016 H1 Operational Highlights
- Successful integration and good sales performance
from our newly acquired US commercial business
- Six months to June $4.58m (£3.19m), growth of 104% vs. H1
2015 ($2.24m)*
- Launch of our 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 started in H1 – investment in our
Bilbao facility
- Good in vivo data achieved
- Planned bioequivalence study to start H1 2017 and filing for
first marketing authorisations anticipated by 2018
Prior to its acquisition by Midatech, DARA Biosciences, Inc. had revenue from product sales of $2.24m in the six months to 30 June 2015
- Product candidate testing in-vivo for glioblastoma
(GBM) and hepatocellular carcinoma (HCC)
- Dana Farber testing Midatech’s targeted nanomedicines
against glioblastoma
- GBM and HCC programmes on track for product selection
by the end of 2016
- Dosing due to commence in Q3 2016 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
In 2016, Midatech Pharma continues to execute against all key areas of its business model
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DIPG (MTX110) named patient basis Ferralet Aquoral Soltamox Gelclair Oravig Zuplenz
Since IPO, Midatech’s R&D portfolio has grown significantly and a US-marketed portfolio has been established
Early-stage portfolio at IPO Progress into a well-balanced portfolio with revenues and pipeline
Brain
Oncology Endocrinology Ophthalmology, Neurology & Others
Ovary Liver Pancreas Q-Cancer Beads GLP1 / Q-Exenatide Combo Q-Octreotide Eye Disease Programmes Blood Brain Barrier Programme Psoriasis Research Collaboration Peptide Research Collaboration Research Pre-C
- Ph. I
Insulin
IPO proceeds and listing facilitated a portfolio step-change
Oncology
Research Pre-C
- Ph. I
- Ph. II
- Ph. III
Sub. Marketed Q-Octreotide (MTD201) Glioblastoma (MTR103) Liver Hepatocellular Carcinoma (MTR104) Squamous Cell Carcinoma (MTR105) GNP TAM Programme GNP Dendritic Vaccine Programme
CNS / Ophthalmology
OpsiSpirin (MTD202)
Partnered Programmes
Ophthotech 1 Ophthotech 2 EU Biotech A – Ophtha Programme Type 1 diabetes vaccine MTX102 FP7 EU
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IPO funds provided:
- Significant uplift in
R&D productivity
- Facilitated on-market
product acquisitions
- Enabled
commercialisation
Marketed in the US
CED/DIPG (MTX111)
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Products & commercial platform
Midatech Pharma US (MTPUS): Fully Integrated Commercial Platform
MTPUS Commercial Operations
- MTPUS has an effective commercial platform to sell and market our
current oncology supportive care portfolio (6 products)
- 25 representatives in the highest prescribing oncology markets
- Year-on-year sales up 104% to $4.5 million
- Established through acquisition of DARA BioSciences, Inc. for $24 million
the complementary product Zuplenz for $3.75 million*
- Creates potential peak sales opportunity of $50 million
- Internal development pipeline will help to achieve scale
- Long-term cash flows to fund on-going biotechnology programmes
Initial consideration subject to certain adjustments and additional, conditional payments
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Zuplenz
- Post-chemo radiotherapy anti-nausea and vomiting product
- Acquired for $3.75m (plus back-end milestones based on
excess over forecast sales)
- Expected pay-back time <18 months
- 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
- Coverage 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)
- Lead product in uncompetitive environment
(compounded magic mouthwash)
- Coverage 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
- Sales history 2014-5 :
- 2014 – Gross $2.1m / Net $1.7m
- 2015 – Gross $4.5m / Net $3.3m
- Estimated peak annual sales potential c$10m
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Oravig
- Buccal Tablet for treatment of Oral “Thrush” associated with
Radio/ Chemo and in HIV patients
- Launched in October 2015
- Coverage by 11/13 Commercial Insurers (>250m Population)
- Over 4m rx written annually for localised treatment
- 0.1% market share = $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
- Annual sales potential c$10m
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Research & development
Development Pipeline: 10 Programs
12 RESEARCH PRECLINICAL PHASE I PHASE II
Immunotherapy Cancer
OpsiSporin Uveitis MTD202
CNS/Ocular
Q-Octreotide Carcinoid MTD201 Glioblastoma MTR103 DIPG Pontine Glioma MTX110 named patient basis Liver Hepatocellular Carcinoma MTR104 Immuno-Oncology Vaccine MTR
Immuno-Oncology TAM MTR
PHASE III
Squamous Cell Carcinoma MTR105 Type 1 Diabetes Vaccine MTX102
Development of multiple, high-value, targeted therapies for major diseases with unmet medical need
CED/DIPG MTX111
Key Partnerships Pipeline
13 RESEARCH PRECLINICAL PHASE I PHASE II
Immunotherapy CNS/Ocular
- Partnered development programmes for high-value, targeted therapies for further indications
- Partnerships and collaborations with specialty and major pharmaceutical companies and universities
- Already revenue generating
Ophthotech 1 Ophthotech 2 EU Biotech A – Ophtha Programm Type 1 Diabetes Vaccine MTX102 FP7 EU
Sustained Release Microsphere Technology
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 reaction
Steps to commercialisation
- Pilot human pharmacokinetic study planned Q1 2017,
followed by bioequivalence or therapeutic equivalence programme in H1 2017
- Marketing authorisation submission anticipated in the
period Q4/17 - Q4/18
Currently in final stages pre-clinical development
- Formulation complete
- Entering bio-equivalence or therapeutic equivalence studies end 2016/7
- Planned US launch in 2018/9
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 pa
- Own sales targeted in the USA
- Centurion out-licence achieved for Turkish rights
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
Long-acting formulation of Octreotide acetate for chronic treatment of carcinoid (cancer) & acromegaly Market worth over $2bn (Sandostatin LAR $1.6bn)
01 02 03 04 05
Opsisporin (MTD202)
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Development pathway
- IND enabling to commence Q4 2016
- toxicology program will complete approx. Q4 2017
- Phase I Q4 2017/Q1 2018
Successful PoC completed in several animal models
- Clear dose response established in prophylactic model
- Efficacy to be established in therapeutic model
- Terminal sterilisation study underway
Intravitreal injection via 27-30G needle directly to vitreous and posterior eye, with minimal transfer to the blood Orphan Indication. Designation application to be submitted September 2016
Advantages
- 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 OpsiSporin is injectable sustained release formulation
- f cyclosporine for treatment of non-infective uveitis
Uveitis growing rapidly ~$1.3bn market, current treated by eyedrops, immuno-suppressives or systemic
01 02 03 04 05
GNP Oncology Nanotechnology
Glioblastoma (GBM) (MTR103)
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Combined targeting and therapeutic
- Development in conjunction with Dana Farber institute
- Candidate selection planned Q3 2016
- IND enabling to commence by end of 2016
- Filing for marketing authorisation anticipated by 2018
Survival typically 12 to 15 months
- Less than 5% surviving greater than five years
Orphan Indication – designation application to be submitted
- GNP’s targeted to bind tumour
specific receptors on GBM cells; internalised GNPs developed to release therapeutic payload intracellularly
- GNP design customised to maximise
uptake for specific GBM indication Worldwide estimated 240,000 cases of brain and nervous system tumours per year
- GBM is most common, and most lethal, of these tumours
Systemic and intra-tumoural administration
01 02 03 04 05
Liver Hepatocellular Carcinoma (HCC) (MTR104)
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Combined targeting and therapeutic
- Candidate selection planned H2 2016
- IND enabling to commence Q4 2016, Q1 2017
Surgical resection major treatment option
- But only 10 – 20% can be removed completely
Current chemotherapeutic options too toxic
- Opportunity to reduce through targeting
- Target receptors on HCC tumour
cells GPC3 to bind and internalise GNPs where the therapeutic payload would be released Sixth most frequent cancer globally and the second leading cause of cancer death Orphan Indication – designation application to be submitted
01 02 03 04 05
DIPG: Diffuse Interstitial Pontine Glioma (MTX110)
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Midatech actively pursuing local delivery directly into the tumour through Convection Enhanced Delivery (CED) that delivers therapeutic constructs via a series of catheters fixed into the substance of the tumours Ultra-high unmet need, potential orphan indication Compassionate use/named patient program: MTX110
- UK: the first UK patient continues to be infused
monthly (6 infusions to date)
- US: a single patient received their first dose In August
MTX 111
- Other DIPG constructs in R&D:
Maytansinoids (AT), Doxorubicin (TPI2), Cilengitide (RGD), Irinotecan (TPI1), Aurostatins (AT; vedotins), HDACi’s
Ultra rare childhood brain tumour
- c1,000 cases / year worldwide
- Average survival, 7 months; universally fatal
Research & Development next steps:
- Regulatory interactions through 2016 – high level of support for
program by regulatory agencies
- Evaluating clinical trial with ultimately selected construct
01 02 03 04 05
GNP Immunotherapy
GNP ASI Immunotherapy vaccine (MTX102)
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- Combination of Midatech GNP technology and
Antigen Specific Immunotherapy (ASI)
- 20% of population suffer from autoimmune disease
- Current autoimmune treatments suppress whole immune
system which increases risk of infection and cancer
- GNP ASI stimulates a disease-regulating response without
affecting the rest of the immune system
- Initial focus is largest autoimmune disease, diabetes,
however the programme also has broad potential applicability in oncology
- Positive pre-clinical data
- GNP ASI substantially enhances disease-regulating response
- Preferentially targets specific immune cells
- Clinical and commercial production
- Manufactured in-house with fill and finish by CMO
- DEVELOPMENT
- Phase I study start Q3 2016, complete Q4 2016
- Regulatory approvals for studies obtained in UK and
Sweden
Immunotherapy ‘Pipeline’
Antigen Specific Immunotherapy (ASI):
- GNP ASI data suggests enhanced tolerogenic response in autoimmune disease
Dendritic or Peptide Vaccine
- GNP peptide conjugates enhance proliferation of cytotoxic antigen-specific CD8+ T cells
Tumour Associated Macrophages
- GNP conjugates activate M2 macrophages towards a classical M1 cancer killing phenotype
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Financials
2016 H1 Financial Highlights
- Total revenue grew from £0.32 million in H1 2015 to £3.80 million (up 1,088%)
- Research and development costs of £2.05 million, a 13% increase from £1.82 million in H1 2015
- Administrative expenses increased from £3.77 million in H1 2015 to £6.82 million (up 81%), primarily due
to the Company’s enlarged commercial infrastructure from the acquisition of Midatech Pharma US
- Net cash outflow used in operations (after changes in working capital) was £8.25 million, up 55% from
£5.31 million in H1 2015. The cash balance at 30 June 2016 was £7.23 million
- Loss per share increased by 39% to 25p (H1 2015: 18p)
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Consolidated Income Statement
Six months ended 30 June 2016 Six months Ended 30 June 2015
£'000 £'000 Revenue 3,456 121 Grant revenue 347 203 _______ _______ Total revenue 3,803 324 Cost of sales (1,032)
- _______
_______ Gross profit 2,771 324 Research and development costs (2,048) (1,822) Distribution costs, sales and marketing (4,237)
- Administrative costs
(6,821) (3,768) _______ _______ Loss from operations (10,335) (5,266) Finance income 765 28 Finance expense
- (12)
_______ ________ Loss before tax (9,570) (5,250) Taxation 1,365 356 _______ ________ Loss after tax attributable to the owners of the parent (8,205) (4,894) ________ ________ Loss per share Basic and diluted loss per ordinary share – pence (25p) (18p)
As at 30 June 2016 As at 31 Dec 2015 £’000 £’000
Non-current assets Property, plant and equipment 2,469 1,984 Intangible assets 42,510 41,339 Other receivables due in greater than one year 387 425
_______ _______
45,366 43,710
_______ _______
Current assets Inventories 787 459 Trade and other receivables 1,503 2,496 Taxation 1,723 1,201 Cash and cash equivalents 7,226 16,175
_______ _______
11,239 20,331
_______ _______
Total assets 56,605 64,041
_______ _______
Non-current liabilities Borrowings 1,440 1,508 Deferred tax liability 6,520 6,547
_______ _______
7,960 8,055
_______ _______
Current liabilities Trade and other payables 5,790 7,084 Borrowings 360 442 Derivative financial liability – equity settled 965 1,573 Provisions 799
- _______
_______
7,914 9,099
_______ _______
Total liabilities 15,874 17,154
_______ _______
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Consolidated Balance Sheet
28
Consolidated Cash Flow Statement
Six months ended 30 June 2016 Six months Ended 30 June 2015 £’000 £’000
Cash used in operations (8,248) (5,307) Taxes received 204
- _______
_______ Net cash used in operating activities (8,044) (5,307) _______ _______ Investing activities Purchases of property, plant and equipment (753) (733) Interest received 158
- _______
_______ Net cash used in investing activities (595) (733) Financing activities Payments to finance lease creditors (15) (11) Repayment of borrowings (149) (34) Issue of borrowings
- 102
Share issues net of costs
- 1
_______ _______ Net cash (used in)/generated from financing activities (164) 58 Net (decrease)/increase in cash and cash equivalents (8,803) (5,982) Cash and cash equivalents at beginning of year 16,175 30,325 Exchange gains on cash and cash equivalents (146)
- _______
_______ Cash and cash equivalents at end of year 7,226 24,343 _______ _______
2016 and H1 2017 Expected News Flow
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- Gelclair: Maintenance of growth and leadership
position in US market
- Oravig: First full year of sales in US post launch in
Q4 2015
- Zuplenz: First full year of sales in US post launch
in Q2 2016
- Q-Octreotide human bio-equivalence studies to
commence in H1 2017
- Further preclinical data across multiple
programmes
- Further updates on brain tumour cancer therapy
programme (DIPG) for initial compassionate use patients in H2 2016
- First immunotherapy vaccine to commence
dosing in clinical trials in Q3 2016
- Further deployment of core technologies via
licensing deals to new and existing partners
- Completion of expansion of Bilbao
manufacturing facility for scale-up of sustained release technology in late 2016
Summary
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Leading proprietary platform technologies
- Gold nanoparticles
- Sustained-release delivery
- Targeted delivery and release of existing therapeutics to the “right place” at the “right time”
- 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
Midatech Pharma an international specialty pharma company
- 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
On-track for execution of three-pronged strategy for growth and value creation
Photograph of section through needle showing microspheres Representation of a gold nanoparticle