Full Press Release Details
("Midatech" or the "Company"
or, together with its subsidiaries, the "Group")
Preliminary Results for the Year Ended 31 December
Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), a drug delivery technology
company focused on improving the bio-delivery and biodistribution of medicines, announces its audited preliminary results for the year
ended 31 December 2021.
For more information, please contact:
| Midatech Pharma PLC |
| Stephen Stamp, CEO, CFO |
| Tel: +44 (0)29 2048 0180 |
| www.midatechpharma.com |
| Strand Hanson Limited (Nominated and Financial Adviser) |
| James Dance / Matthew Chandler / Rob Patrick |
| Tel: +44 (0)20 7409 3494 |
| Turner Pope Investments (TPI) Limited (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 |
| Edison Group (US Investor Relations) Alyssa Factor Tel: +1 (860) 573 9637 Email: afactor@edisongroup.com |
About Midatech Pharma PLC
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 each platform:
Q-Sphera platform: a disruptive micro-technology
used for sustained release to prolong and control the release of therapeutics over an extended period of time (from weeks to months).
MidaSolve platform: an innovative nanotechnology
used to dissolve insoluble drugs so that they can be administered in liquid form directly and locally into tumours.
MidaCore platform: a leading-edge nanotechnology
used for targeting medications to sites of disease.
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 announcement 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 announcement 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.
Headquartered in Cardiff, UK, and quoted on the AIM market of the London
Stock Exchange and on NASDAQ in the US, Midatech is an R&D biotechnology company focused on improving the bio-delivery and biodistribution
of medicines using its three proprietary drug delivery technologies.
Our strategy is based on two key themes: multiple shots on goal and
time and cost to partnerability.
Since the announcement of a Strategic Review in March 2020, we have
sought to broaden our R&D pipeline by initiating internal programmes, collaborating with third party pharmaceutical companies on their
proprietary active pharmaceutical ingredients, or APIs, and adding new indications to MTX110, our novel formulation and delivery system
Our realigned strategy is to advance our development programmes to
proof of concept stage before seeking licensee partners to fund further development, manufacturing scale-up and commercialisation.
| Strategic Imperatives | Progress in 2021 | Priorities for 2022 |
| Develop and broaden applications for our three primary drug delivery technologies | In June we announced that we had successfully encapsulated a large molecule protein using Q-Sphera technology and, importantly, preserved the functional integrity and antigen binding of the protein in vitro. In December we filed a patent covering pharmaceutical compositions and use thereof in combination therapy for brain cancer which is expected to offer opportunities to study MTX110 in combination with other, synergistic drugs. Additionally, we filed a new divisional patent around our microparticle production device which is intended to protect a new component in the flow process. | Refine processes to extend the capacity of Q-Sphera to accommodate a wider range of biopharmaceuticals. Generate in vivo data to demonstrate intratumoral delivery of drugs using Q-Sphera technology. Expand further our patent portfolio to cover new inventions and divisionals to strengthen existing patent families. |
| Apply our proprietary technologies to develop compelling products to proof of concept stage | In June, we delivered proof of concept formulations, MTX214 and MTX216, to Janssen Pharmaceutica NV, or Janssen, our collaboration partner. Janssen is a wholly-owned subsidiary of Johnson & Johnson. Janssen then undertook in vivo pre-clinical studies for both formulations. Also in June, we reported that we had successfully developed a long-acting formulation of brexpiprazole using our Q-Sphera technology. In an in vivo study, MTD211 demonstrated that a single dose of MTD211 could deliver therapeutic blood levels of brexpiprazole over a period of three months. There are no long-acting formulations of brexpiprazole currently available. Also using Q-Sphera technology, we developed a long-acting formulation of tacrolimus. In an in vivo study, MTD219 demonstrated a potential dose interval of three-weeks. Currently there are only twice- or once-daily formulations available. In December the 30-day FDA review period expired for our Investigational New Drug application ( IND') for a planned Phase I study of MTX110 in recurrent Glioblastoma Multiforme ( GBM'). The study has been judged safe to proceed. Accordingly, we have initiated preparations for the study to begin enrolling patients in mid-2022. | Identify one or two suitable candidates to add to our internal Q-Sphera pipeline. Secure a partnership with a contract manufacturing organisation, or CMO, to manufacture Q-Sphera products to GMP standards in their facilities such that the products may be used for clinical studies. Market our technologies, their features and benefits at scientific and/or partnering conferences with a view to identifying suitable candidates for our technologies within the R&D portfolios of to third party pharmaceutical companies. We plan to target companies working in the field of peptides and proteins. Obtain preliminary results, likely to be progression-free survival data in a limited number of patients, from our Phase I study of MTX110 in recurrent GBM. |
| Enter into R&D collaborations at the feasibility stage followed by technology and commercialisation licenses post proof of concept | Mid-year, we delivered two proof of concept Q-Sphera formulations as referenced above, to Janssen. We continued to work on the formulation of Janssen's proprietary protein and, in January 2022, we announced that the R&D collaboration with Janssen had been extended to focus on maximizing drug loading and optimizing in vitro duration of release of Janssen's experimental molecule using our Q-Sphera technology. We have initiated discussions with third parties regarding the potential licensing of MTD211 (Q-brexpiprazole). | Enter into R&D collaborations with third parties to formulate their proprietary molecules using Q-Sphera technology with an emphasis on proteins. Secure a licensee on appropriate terms for one of our internal Q-Sphera programmes. Seek a partner to develop, or co-develop, MTX110 once preliminary data from our Phase I study in recurrent GBM become available. |
| Provide a healthy and stimulating environment in which our staff members can continue to thrive and innovate | We established a Task Force to monitor governmental advice and regulation regarding the COVID-19 pandemic. We took appropriate steps to safeguard the health of staff members including remote working where feasible and social distancing in the workplace. In August we moved into new offices and purpose-built laboratories in Cardiff. The new laboratories facilitate improved workflow and a safer, cleaner work environment for our staff. We have been compliant with ISO 9001 since 2014 and again passed an external audit of our quality management system, obtaining the highest level of compliance. During the year, we introduced a new COSHH assessment procedure to better quantify the safety of chemicals and third parties' APIs being deployed in our laboratories. | Continue to monitor third party advice and regulation to maintain a safe environment for our staff members. Develop individualised learning programmes for staff members through participation in conferences, webinars and/or training programmes. |
Since our Strategic Review in March 2020, we have reverted to a traditional
biotech business model. We aim to deploy our proprietary technologies to develop proof of concept formulations and then enter into licensing
agreements with third party pharmaceutical companies.
Our intention is to build a balanced portfolio of Q-Sphera programmes
employing a bi-fold strategy to create an:
We have applied our MidaSolve technology to
panobinostat to create our proprietary product, MTX110. Our development strategy for MTX110 is to demonstrate its utility in a range of
intractable brain cancers with a series of pilot proof of concept studies before seeking licensee partners.
Once a licensing partner has been secured, we would expect any future
development costs to be reimbursed by that partner and for Midatech to receive milestone payments and, ultimately, royalties on sales
To establish proof-of-concept
in pre-clinical studies for potential licensees, we are able to manufacture non-GMP Q-Sphera products at pilot scale at our Cardiff facility.
Our intention is to technology transfer GMP manufacture of clinical trial supplies and ultimately full GMP commercial manufacture to a
third party CMO. We would expect a licensee to assume the cost of manufacturing GMP product and commercial scale-up pursuant to a technology
MTX110 is currently being manufactured
to GMP standards at a CMO.
Once proof-of-concept has been established, we intend to seek to license
our products to a partner who would complete the clinical development and subsequently market and sell them in the licensed territory.
In addition to reimbursement of development costs, the partner would be expected to make milestone payments based on sales targets and
In 2020 Midatech pivoted from a largely singular focus on the clinical
development and manufacturing scale up of MTD201 to a strategy based on a broader, but earlier stage, pipeline. The two strategic drivers
behind Midatech's development pipeline, "multiple shots on goal" and "time and cost to partnerability",
are designed to provide optimal opportunities for partnering success while focusing our resources on those projects that will deliver
near term data that could attract a development partner.
Our development pipeline includes eight projects of which two are partnered
| ID | Technology | API | Therapeutic Area | Administration | Formulation | Pre- clinical | Phase I | Phase II | Partner |
| MTX110 | MidaSolve | Panobinostat | Recurrent Glioblastoma Multiforme | Direct to tumour via CED | X | X | X | ||
| MTX110 | MidaSolve | Panobinostat | Paediatric brain cancer (DIPG) | Direct to tumour via CED | X | X | X | ||
| MTX110 | MidaSolve | Panobinostat | Medulloblastoma | Direct to tumour via CED | X | X | X | ||
| MTD211 | Q-Sphera | Brexpiprazole | Schizophrenia, MDD | Long acting Injectable | X | X | |||
| MTD219 | Q-Sphera | Tacrolimus | Anti- transplant rejection | Long acting Injectable | X | X | |||
| MTX213 | Q-Sphera | Undisclosed | Undisclosed | Undisclosed | X | Janssen Pharmaceutica | |||
| MTX223 | Q-Sphera | Undisclosed | Undisclosed | Undisclosed | X | Janssen Pharmaceutica | |||
| MTX114 | MidaCore | Methotrexate | Mild to moderate psoriasis | Topical | X |
Our Q-Sphera technology employs 3-D printing techniques
to encapsulate medicines in polymer-based bioresorbable microspheres. The microspheres may be injected to form depots in the body which
release drug over predictable, sustained periods from one week up to several months. The features and benefits of Q-Sphera technology
offer numerous potential advantages to patients and payors compared with immediate release products and other polymer-based technologies:
| FEATURES | ||||||
| Biocompatible biodegradable | Small footprint, scalable manufacturing | Low viscosity, small gauge needles | Tuneable, predictable | Homogenous, monodispersed | Localised delivery | Sub cutaneous Intra muscular Intra tumoral Intra articular Intra ocular |
| Increased dosage intervals | Low cost, environment friendly | Improved injectability | Targeted to therapeutic window | Low inter-patient variability | Targeted site of action, lower systemic toxicity | |
| BENEFITS |
In addition, Q-Sphera products offer the possibility
for targeted delivery to the site of disease including intra tumoral, intra articular and intra ocular applications, in each case offering
the potential for reduced dose and reduced systemic toxicity.
We have an internal Q-Sphera pipeline including
MTD211, a long-acting injectable formulation of brexpiprazole. Brexpiprazole, marketed as Rexulti , is indicated for schizophremia
and as an adjunct in the treatment of Major Depressive Disorder, or MDD.
We are also developing MTD219, a long-acting
injectable formulation of tacrolimus, marketed as ProGraf for the prophylaxis of transplant rejection.
In addition, we are working to optimise the
drug loading and dissolution profiles of two large molecules, MTX213 and MTX223 under collaboration agreements with our partner Janssen.
Our MidaSolve technology increases the aqueous
solubility of certain classes of anti-cancer drugs using complexes that solubilize these agents in water, thereby enabling them to be
injected in liquid form directly into tumours.
The MidaSolve complexation agents (cyclodextrins)
comprise a hydrophobic inner surface and a hydrophilic outer surface, and as a result are capable of forming host-guest complexes with
normally water-insoluble molecules. The hydrophobic, poorly water-soluble drug associates with the inner, more hydrophobic surface of
the MidaSolve host, while the hydrophilic outer surface allows the complex to dissolve at biological pH.
Using our MidaSolve technology in combination with panobinostat, an