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September 2020 Midatech Pharma Plc ("Midatech" or the "Company") Interim results for the six months ended 30 June 2020 R&D Collaboration Strategy Gaining Traction Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), a drug de

Key Takeaway: ("Midatech" or the "Company") Interim results for the six months ended R&D Collaboration Strategy Gaining 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

Full Press Release Details

("Midatech" or the "Company")
Interim results for the six months ended
R&D Collaboration Strategy Gaining
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 unaudited interim results for the six months ended 30 June 2020.
OPERATIONAL HIGHLIGHTS (including
FINANCIAL HIGHLIGHTS (including
announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
For more information, please contact:
Midatech Pharma PLC
Stephen Stamp, CEO, CFO
Tel: +44 (0)29 20480 180
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 (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) Megan Paul Tel: +1 (646) 653 7034 Email: mpaul@edisongroup.com
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 bio-distribution 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 each platform:
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.
CHIEF EXECUTIVE'S REVIEW
The first half of 2020 proved to be a period
of significant transition for Midatech. We began the half-year with positive results from our Phase I study comparing subcutaneous
and intramuscular administration of MTD201, conferring the potential for an additional patient and cost benefit of the product.
Preparations for Phase III were well advanced when the dislocation in the capital markets which began in mid-February combined
with the limited prospects for partnering of assets at that time, caused the Board to reassess and the Company began a wide-ranging
strategic review of its operations.
Strategic Review and Formal Sale Process
On 31 March 2020 we announced that the
Company was initiating a formal Strategic Review. The Board had concluded that, in the context of its cash runway, the Company
was unlikely to consummate a license transaction or raise sufficient funds to continue the required remaining investment in MTD201
of approximately US$30 million on a timely basis. We therefore decided to terminate further inhouse development of the MTD201 programme
with immediate effect, although the asset remains available for licensing. We also took the difficult decision to close the Company's
MTD201 dedicated manufacturing facilities in Bilbao, Spain and offer redundancy to all 42 employees. In addition, a further five
UK-based employees in clinical research and administrative roles were also offered redundancy.
On 20 April 2020, we announced that we
had appointed Noble Capital Markets Inc. to advise the Board in considering all options for extracting value from its technologies
and optimising outcomes for the Company's shareholders including partnering clinical stage assets, partnering or selling
one or more technologies, or selling the Company by way of a "Formal Sale Process" under the Takeover Code. We did
not receive any proposals for the acquisition of the Company under the Code and, accordingly, the Formal Sale Process was terminated
in July. We are evaluating expressions of interest from third parties for the potential acquisition of certain assets of the Company
All activities connected with MTD201 have
been wound down expeditiously and the manufacturing facilities in Bilbao have been closed. Following the termination of in-house
development of MTD201, we realigned our strategy for exploiting our Q-Sphera technology as discussed under Commercial Update
As a result of the Strategic Review, Midatech's
remaining 20 employees and operations are now concentrated in Cardiff. The Company's strategy was immediately pivoted to
deploy its proprietary Q-Sphera drug delivery technology to (1) formulate a compelling portfolio of novel products with significant
commercial potential for licensing to pharmaceutical company partners; and (2) formulate proprietary compounds of pharmaceutical
partners under collaboration agreements.
The Company's commercial strategy
is gaining traction. On 8 June 2020, we announced a collaboration with Dr Reddy's Laboratories Ltd and on 21 July 2020 we announced
a second collaboration with a European affiliate of a global pharmaceutical company, in each case to explore the feasibility of
applying Midatech's Q-Sphera technology to the partners' proprietary products. One of our partners has extended the initial collaboration
to two products. We believe the collaborations are encouraging early validation of the technology platform and, if successful,
we would expect to enter into licensing and technology transfer agreements with partners including milestone payments and royalties
with the medium term goal of becoming a self-sustaining, profitable business.
With termination of further inhouse development
of MTD201 and change in strategic emphasis towards collaborating and partnering at proof-of-concept stage, the Company's
R&D portfolio is significantly more diversified as follows:
ID API Therapeutic Area Administration Formulation Pre- clinical Phase I Phase II Partnering Status
Q-Sphera
MTD211 Small molecule CNS Long acting Injectable X
MTD214 Small molecule Anti-rejection Long acting Injectable X
MTD215 Monoclonal Antibody Undisclosed Long acting Injectable Investigational
External: MTX212 Undisclosed Undisclosed Long acting Injectable X Partnered
External: MTX213 Undisclosed Undisclosed Undisclosed X Partnered
MTX214 Undisclosed Undisclosed Undisclosed X
MTD201 Octreotide Carcinoid cancer and acromegaly Long acting injectable In-house development terminated
MidaSolve
MTX110 Panobinostat Brain cancer in children (DIPG) Direct to tumour via CED X X X
MTX110 Panobinostat Medulloblastoma Direct to tumour X X
MTX110 Panobinostat Glioblastoma Direct to tumour via CED X
MidaCore
MTX114 Methotrexate Psoriasis Immuno-rx Topical X X
Since the start of the Strategic Review
the Company has developed two formulations for its internal Q-Sphera pipeline: one in CNS (MTD211) and one in transplant anti-rejection
(MTD214). Each of the APIs was identified after a comprehensive evaluation of potential candidates. Both MTD211 and MTD214 address
large markets and, as long-acting injectables, have the potential to offer significant clinical benefits compared with current
therapies and, importantly for reimbursement, savings to the healthcare system. Both formulations are currently being optimised
in preparation for IND-enabling in vivo studies later this year. Once completed, we will seek licensing and technology transfer
agreements with partners for further development and, ultimately marketing.
Insofar as the Company is aware, there
are no FDA approved long-acting injectable formulations of biologic products such as monoclonal antibodies or other forms of high
molecular weight proteins. Proteins are delicate and easily de-natured in manufacturing processes which require significant shear
forces, heat and/or certain types of solvent. Midatech's Q-Sphera encapsulation printing technology is inherently less harmful
than most traditional PLGA manufacturing methods. A significant number of latest generation medicines are protein based and could
benefit from alternative dosing with long-acting injectables and, although there remain significant technical challenges, Midatech's
MTD215 programme is investigating the feasibility of encapsulating a monoclonal antibody using a model protein, representative
of closely related therapeutics, to demonstrate proof of concept. If successful, the Company plans to apply the know-how to commercial
MTD201, a long-acting Q-Sphera formulation
of octreotide for the treatment of acromegaly and neuroendocrine tumours, reported a second Phase I study ("Study 102")
in 28 healthy volunteers comparing subcutaneous versus intramuscular routes of administration. The results showed similar pharmacokinetics
and bioavailability for the two routes of administration. Although inhouse development of MTD201 has been terminated, the pre-clinical
and two Phase I studies have demonstrated Q-Sphera proof-of-concept as a long-acting injectable formulation technology with several
potential advantages compared with other PLGA-based technologies including; predictable kinetics, minimal burst release, improved
injectability, simpler reconstitution and now, subcutaneous administration.
The Company's MidaSolve project,
MTX110, is being developed initially for the treatment of an ultra-rare, highly aggressive and inoperable form of childhood brain
Last updated: Sep 10, 2020