Recent Updates
Recently added Catalysts
BDRX

June 2020 Midatech Pharma Plc ("Midatech" or the "Company") Preliminary results for the year ended 31 December 2019 Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), a drug delivery technology company focused on improving

Key Takeaway: ("Midatech" or the "Company") Preliminary results for the year ended Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), a drug delivery technology company focused on improving the bio-delivery and bio-distribution of medicines announces its audited preliminary results for the ye

Full Press Release Details

("Midatech" or the "Company")
Preliminary results for the year ended
Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), a drug delivery
technology company focused on improving the bio-delivery and bio-distribution of medicines announces its audited preliminary results
for the year ended 31 December 2019.
Financial highlights
Operational highlights
Post period end highlights
Stephen Stamp, CEO and CFO commented "This has been an
extremely difficult period for Midatech with the termination of in-house development of our lead programme, closure of our Bilbao
operations and the loss of 47 jobs, over two-thirds of our employees. I should like to recognise the professionalism of the team
in making these difficult decisions and the grace with which they have been accepted. Our focus now is to evaluate
all available options for extracting maximum value from Midatech's platform technologies."
For more information, please contact:
Midatech Pharma PLC
Stephen Stamp, CEO, CFO
Tel: +44 (0)1235 888300
www.midatechpharma.com
Panmure Gordon (UK) Limited (Nominated Adviser and Broker)
Freddy Crossley, Emma Earl (Corporate Finance)
James Stearns (Corporate Broking)
Turner Pope Investments (TPI) Limited (Joint Broker)
Andrew Thacker (Corporate Broking)
Tel: +44(0)20 3657 0050
IFC Advisory Limited (Financial PR and UK Investor Relations)
Tim Metcalfe / Graham Herring
Tel: +44 (0)20 3934 6630
Email: midatech@investor-focus.co.uk
Edison Group (US Investor Relations) Joseph Green/ Laine Yonker Tel: (646) 653-7030/ 7035 jgreen@edisongroup.com/ lyonker@edisongroup.com
Listed on AIM and NASDAQ, Midatech is headquartered in Cardiff,
UK. Following the announcement of a strategic review on 31 March 2020, the Company has terminated in-house development of MTD201
and is in the process of closing down its operations in Bilbao, Spain. After the closure, Midatech's remaining 20 employees
will be focused on extracting value from its technology platforms. On 20 April 2020, the Company provided a further update to the
strategic review including the appointment of Noble Capital Markets, Inc. to advise the Board and the initiation of a "formal
sale process" under the City Code on Takeovers and Mergers.
Midatech is focused on developing products based on its three
proprietary platform technologies, designed to deliver therapeutic drugs to the right place at the right time. The Company has
three proprietary drug delivery technologies based on 120 granted patents, 70 applications in-process across 36 patent families:
Q-Sphera MidaSolve MidaCore
Technology Micro-encapsulation PLGA polymer depot system Advanced piezo printing technology Several million microspheres produced per second Solubilises inherently insoluble drugs Nano inclusion technology for chemotherapeutics Complex has hydrophobic core and hydrophilic surface Gold nanotechnology to deliver chemo / immuno therapeutics Key attributes are small size and multi-valent binding sites Decorated with therapeutic and targeting moieties
Clinical Superior sustained-release pharmacokinetics Improves usability, patient experience and compliance Enhanced dosing and administration routes Converts oral drugs into liquid administration forms Enables infusion directly into the tumour Aim to enhance efficacy and reduce toxicity Size (2-4nm) improves delivery, targeting, reduces toxicity Enters immune cells to enhance immune responses against tumour cells Research programmes in psoriasis and solid tumours
Manufacture Scalable, efficient high yield manufacture Modest infrastructure, environmentally very friendly Low CoGS and broad API compatibility Multiple patent families Simple manufacturing process No solvents, non-toxic Lyophilised powder, long shelf-life Product-specific patents Simple manufacturing process Modest infrastructure Multiple patent families
We have established proof of concept formulations using all
three drug delivery platforms and have been tested in human clinical trials
CHIEF EXECUTIVE'S REVIEW
The decisions we took in the second half of 2018 to sell our
US sales and marketing business and close our Abingdon R&D facility, while painful at the time, resulted in increased focus
and determination to advance our lead programmes through the clinic.
The clarity of our strategy and the simplification of the investment
case enabled us to attract new investment, both dilutive and non-dilutive, into the Company during 2019. That, in turn, allowed
us to start Phase I studies in each of our two lead programmes and report our MTD201 102 study in January 2020.
Like most development-stage biotech companies, Midatech is reliant
on licensing revenues and/or cash injections from investors to fund operations. Unfortunately, in view of the precipitous fall
in global capital markets in the first quarter of 2020 and the prospects for raising additional funds and partnering of assets,
the Board concluded Midatech could no longer continue to fund MTD201. As a direct consequence, the Company's operations in
Bilbao which are largely dedicated to the manufacturing and scale-up of MTD201, will be closed. Significant progress was made in
the development of MTD201 during 2019 and early 2020 and the asset remains available for licensing to a third party.
Our R&D strategy remains clear and robust. By applying our
proprietary drug delivery technology to existing approved medicines, we can make them better, generate new products, and/or give
products new patent life. We do not take typical biotech' risks on the side effects or efficacy of the medicine, since
these are already approved products. We only need prove that our technology delivers the drug as required and confers one or more
advantages over the originator product such as usability, greater efficacy, lower side effects, ease of manufacture and/or lower
MTD201 (octreotide using Q-Sphera technology)
The 101 Phase I study which reported in August 2018
in 24 healthy volunteers comparing MTD201 with Sandostatin LAR (SLAR) demonstrated MTD201 had a host of advantages over SLAR.
These include a longer dosing profile, less inter patient release kinetics variability, no initial burst release, smaller needle
gauge resulting in less painful injections and injection site reactions and quicker, simpler reconstitution of the product. Based
on extensive regulatory and opinion leader input, we determined that developing MTD201 as a differentiated product would be more
valuable commercially and medically than a generic version of SLAR. We initiated the '102 Phase I study in 28 healthy volunteers
comparing subcutaneous versus intramuscular administration of MTD201 which reported headline data in January 2020 and showed similar
kinetics and bioavailability for the two routes of administration. These latest results further differentiated MTD201 from SLAR
and offer the potential for patients to administer therapy themselves at home, significantly reducing the frequency of hospital
visits and therefore payer costs.
Our two Phase I trials have already established a number of
key advantages of MTD201 compared with the currently available therapies in the market as illustrated in the following table:
Demonstrated Advantages of MTD201 vs. Sandostatin LAR Study Information Status
Clinical Study Phase Subjects Design
Favourable release profile (with intramuscular injection) MTD201-101 Phase I 24 healthy volunteers Randomized, double blind Completed
Minimal burst release
Less painful injections & injection site reactions
Smaller needle gauge
Quicker, simpler reconstitution and injection
Confirmation of higher strengths (30mg - 90mg) MTD201-Lab Research None Laboratory research Completed
Subcutaneous dosing in addition to intramuscular dosing MTD201- 102 Phase I 24 healthy volunteers Randomized, open label Completed, preliminary data
The next step for MTD201 would be the preparation for the pivotal
trial in acromegaly. These preparations were underway and a CRO had been appointed to manage the trial. Following the Board's
decision in March 2020 to terminate in-house development of MTD201, all MTD201 activities are being wound down as expeditiously
MTX110 (panobinostat using MidaSolve technology)
DIPG is an intractable cancer of the brain, most common in children.
MTX110 may be an important advancement in transforming patient outcomes. Our 101 Phase I study being conducted by UCSF requires
the recruitment of one more patient in the first in-human clinical trial of MTX110 and is expected to report safety and tolerability
in mid 2020. This study which includes dose escalation, is designed to confirm the dose for a Phase II trial of safety and efficacy
study in 19 patients with Kinderspital, Zurich and the Princess M xima Center, Utrecht using a Convection Enhanced Delivery
(CED) system whereby MTX110 will be infused under slight pressure directly into and around the tumour. The primary endpoint of
the study will be patient survival rates after 12 months. Start of the Zurich / Utrecht study was contingent on the receipt of
the 2.7 million GlioKIDS grant from the EU. Receipt of this grant, which was provisionally awarded in December 2019, is dependent
upon confirmation of Midatech falls within the EU definition of an SME. Following the successful fundraising in May 2020, the Phase
II trial will now move ahead. We have also initiated an exploratory trial in five patients with DIPG at Columbia University, New
York using an alternative CED infusion system although recruitment may be impacted by restrictions on movement of patients due
MTX110 was awarded orphan drug designation for DIPG in October
2019 and, subject to further favourable results from the studies, we could pursue accelerated approval, a fast track process generally
reserved for orphan conditions where there are no existing treatments.
We are evaluating other indications in which MTX110 might make
Whilst we have directed our resources to the MTD201 and MTX110
products, there are several early phase programmes based on the MidaCore gold nanoparticle targeted delivery platform that may
be progressed, subject to receiving further funding. First among these will be MTX114, a topical methotrexate-complexed gold nanoparticle
that has been shown to be better tolerated and more effective than systemic methotrexate in animal psoriasis models.
Financing activities
Like many companies in our sector, funding and therefore resource
allocation is an ongoing challenge. We met this challenge head-on in 2019, raising a total of 17.2 million in additional
funding, net of expenses. This included 3.1 million of non-dilutive funding and 14.1 million of equity and equity-related
funding. The company recognised 1.1m as a warrant liability in relation to the fundraising completed on NASDAQ in October
Non-dilutive funding in the year was a 6.6 million ( 5.6
million) loan under the Spanish Government's Reindus programme, offset by a deposit by the Company of 3.0 million ( 2.5
million). In addition, we were awarded a 1.5 million ( 1.3 million) soft loan (Guazatu) from the Basque regional government,
which was not drawn down during 2019. Both loans were earmarked to support the commercial scale-up for MTD201 and the Q-Sphera
platform in our Bilbao manufacturing site. As a result of the Strategic Review announced in March 2020 the Reindus loan will be
repaid and the Guazatu loan cancelled following the decision to terminate inhouse development of MTD201 and close Bilbao operations.
In December 2019 we were awarded, subject to meeting the EU's definition of an SME, of a grant from the EU of 2.7 million
( 2.3 million) to support the Phase II trial of MTX110 in DIPG at Kinderspital, Zurich and Princess M xima Center,
In terms of equity and equity-related financings, there were
two events. In February 2019, we raised a total of 12.3 million, net of expenses, from a combined subscription, placing
and open offer of "Units" comprising one ordinary share at 3.85p and one warrant exercisable at 50p, adjusted to 77p
and 10.00 respectively on a post share consolidation basis. Of the total invested, 8.0 million was subscribed by
Last updated: Jun 16, 2020