Full Press Release Details
for the six months ended 30 June 2021
PLC (AIM: MTPH.L; NASDAQ: MTP), a drug delivery technology company focused on improving the bio-delivery and biodistribution of medicines,
announces its unaudited interim results for the six months ended 30 June 2021.
the Company announced significant progress across a number of R&D programmes including:
FINANCIAL HIGHLIGHTS
(including post period end)
Stamp, CEO and CFO of Midatech said: "We are pleased to report good progress throughout the Company and an expanded and exciting
pipeline of programmes and opportunities. The disruption and costs of the restructuring in 2020 are now behind us. The first half of 2021
has been highly productive with three potentially viable Q-Sphera formulations, one internal and two for a collaboration partner. We believe
the breakthrough data on the encapsulation of a protein could prove to be a very significant opportunity for Midatech."
Company will be hosting a webinar at 5.30pm BST / 12.30pm EST on Monday 20 September 2021. The webinar is open
to all existing and potential shareholders and those interested in attending may register via the following link where, following registration,
they will be provided with access details:
may submit questions during the webinar or in advance via email to: midatech@investor-focus.co.uk
announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) 596/2014 as it forms part of
UK domestic law by virtue of the European Union (Withdrawal) Act 2018 ("MAR"), and is disclosed in accordance with the
company's obligations under Article 17 of MAR.
For more information,
| Midatech Pharma PLC |
| Stephen Stamp, CEO, CFO |
| Tel: +44 (0)29 2048 0180 |
| www.midatechpharma.com |
| Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker) |
| Freddy Crossley, Emma Earl (Corporate Finance) |
| Rupert Dearden (Corporate Broking) |
| Tel: +44 (0)20 7886 2500 |
| Turner Pope Investments (TPI) Limited (Joint Broker) |
| Andrew Thacker / James Pope (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 |
About Midatech Pharma
Midatech Pharma PLC (dual
listed on LSE AIM: MTPH; and NASDAQ: MTP) is a drug delivery technology company focused on improving the bio-delivery and biodistribution
of medicines. The Company combines approved and development medications with its proprietary and innovative drug delivery technologies
to provide compelling products that have the potential to powerfully impact the lives of patients.
The Company has developed
three in-house technology platforms, each with its own unique mechanism to improve delivery of medications to sites of disease. All of
the Company's technologies have successfully entered human use in the clinic, providing important validation of the potential for
The platform nature of
the technologies offers the potential to develop multiple drug assets rather than being reliant on a limited number of programmes. Midatech's
technologies are supported by 36 patent families including 120 granted patents and an additional 70 patent applications. Midatech's headquarters
and R&D facility is in Cardiff, UK. For more information please visit www.midatechpharma.com
Forward-Looking Statements
Certain statements in
this press release may constitute "forward-looking statements" within the meaning of legislation in the United Kingdom and/or
United States Private Securities Litigation Reform Act. All statements contained in this press release that do not relate to matters of
historical fact should be considered 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 announcement. 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 or otherwise arising.
following the announcement of our Strategic Review, we have rationalised operations including the shutdown of our Bilbao operations, thereby
halving our monthly cash burn rate and pivoted from a largely singular focus on one Phase III ready asset (MTD201, Q-Sphera octreotide)
to a "multiple shots on goal" strategy with an expanded pipeline of 10 earlier stage programmes as follows:
| ID | API | Therapeutic Area | Administration | Formulation | Pre- clinical | Phase I | Phase II | Partnering Status |
| Q-Sphera | ||||||||
| Internal: | ||||||||
| MTD211 | brexpiprazole | Psychosis, MDD (adjunct) | Long acting Injectable | X | X | |||
| MTD214 | tacrolimus | Anti-rejection | Long acting Injectable | X | X | |||
| MTD220 | Proteins (incl mAb) | Undisclosed | Long acting Injectable | Investigational | ||||
| External: | ||||||||
| MTX213 | Undisclosed | Undisclosed | Undisclosed | X | X | |||
| MTX214 | Undisclosed | Undisclosed | Undisclosed | X | X | |||
| MTX216 | Undisclosed | Undisclosed | Undisclosed | X | ||||
| MidaSolve | ||||||||
| MTX110 | panobinostat | Glioblastoma Multiforme (GBM) | Direct to tumour via CED | X | X | |||
| MTX110 | panobinostat | Diffuse Intrinsic Pontine Glioma (DIPG) | Direct to tumour via CED | X | X | X | ||
| MTX110 | panobinostat | Medulloblastoma | Direct to tumour | X | X | X | ||
| MidaCore | ||||||||
| MTX114 | methotrexate | Psoriasis | Topical | X | X |
of 2021 was highly productive in terms of advancing our R&D pipeline, culminating in the announcement of breakthrough data on the
successful encapsulation of a biologic using Q-Sphera technology and significant progress across multiple other R&D programmes on
Q-Sphera technology employs proprietary 3-D printing techniques to encapsulate drugs in polymer-based bioresorbable microspheres which
may be injected to form depots in the body which release drug over predictable, sustained periods from one week to several months. Progress
of the Q-Sphera pipeline in 1H21 includes:
(incl mAb) formulation
are no approved long-acting injectable formulations of biologic products such as mAbs or other high molecular weight proteins primarily
because they are delicate and easily de-natured in manufacture. We have been working on several proteins including two exemplar mAbs and
thus far, have demonstrated encapsulation of the mAb and most importantly, preservation of its functional integrity and antigen binding
in vitro. We believe no other commercial or academic organisation has been able to successfully deliver therapeutic proteins over
extended periods using methods capable of commercial scaling.
believe these results could open up very significant opportunities for our Q-Sphera technology. A significant number of latest generation
medicines are protein based and reformulation as long-acting injectables could provide significant benefits to patients, physicians and
at reduced cost to payors. In 2020, the top 10 mAbs recorded aggregate sales of US$74.9 billion1 and all mAbs US$154 billion1
steps will be to further optimise the drug loading and dissolution profile for encapsulated mAbs. In parallel, we are seeking to replicate
the data seen with the first exemplar mAb and we are evaluating multiple high value mAb therapeutics to add to our internal pipeline.
MTX214 and MTX216 are being developed under collaboration agreements with the European affiliate of a global healthcare company. We manufactured
and delivered proof of concept formulations of both MTX214 and MTX216 to the collaboration partner who, in turn, is undertaking in
vivo studies with both formulations.
of our internal pipeline, we have successfully developed a long-acting formulation of brexpiprazole. In in vivo studies, MTD211
was well tolerated and demonstrated that a single injection of MTD211 is expected to deliver therapeutic blood levels of brexpiprazole
over a period of three months.
under the brand name Rexulti , brexpiprazole is indicated for the treatment of schizophrenia and adjunctive treatment of major depressive
disorder (MDD) and is currently only available as an immediate release oral tablet. The market for anti-psychotic drugs is shifting towards
long-acting formulations for reasons of improved patient compliance and lowering of payor costs associated with patient hospitalisation
events as evidenced by the recent approval of Invega Hafyera for schizophrenia. Sales of long-acting anti-psychotic products in
2020 were approximately US$5.7 billion2 globally.
initiated discussions with third parties about a potential licencing of MTD211. There can be no assurance on
the timing for concluding these discussions nor any assurance that the parties will enter into definitive agreements.
formulation of panobinostat administered through convection enhanced delivery, is in clinical development for intractable brain cancers
including Diffuse Intrinsic Pontine Glioma (DIPG) and Glioblastoma Multiforme (GBM).
Following a constructive
pre-IND meeting with the FDA in June 2021, we are planning to initiate a Phase II study in DIPG as soon as possible after the recruitment
and treatment of the remaining four patients in the ongoing Phase I study at Columbia University. The Phase II study is expected to be
open label with two doses in newly diagnosed patients. Administration of MTX110 will be via convection enhanced delivery (CED) over 48
hours in six cycles, two to four weeks apart. Primary endpoints will be safety, tolerability and overall survival at 12 months (OS12).
Approximately 1,000 patients3 globally are diagnosed with DIPG per annum and median survival is approximately 10 months4.
in vivo data that were presented at the 2020 annual meeting of The Society of Neuro-Oncology which demonstrated the efficacy of
MTX110 against two GBM cell lines in an ectopic tumour model, in 1H21 we demonstrated the potency, at therapeutic concentrations, of MTX110
against a further four patient-derived GBM cell lines in vitro. We are planning a Phase I pilot study in GBM patients to begin
enrolment in the next few months. There are GBM diagnoses of 2 to 3 per 100,000 population per annum5 and survival ranges from
13 to 30 months depending on MGMT methylation6.
("Secura Bio"), the owner of Panobinostat, terminated the Company's licence to certain panobinostat patents in June
2020. Notwithstanding Secura Bio refusing in writing three times to withdraw that termination, the Company has received further correspondence
claiming termination in May 2021, this time for material breach of the terms of the licence and is demanding, among other things, that
the Company grant Secura Bio a non-exclusive, free licence to its intellectual property and know-how. The Company believes that such claims
and demands are without any merit and will defend them robustly.
Contract negotiations
with a third party in respect of a potential co-development deal are continuing, although at a slower pace than anticipated due to issues
associated with COVID-19.