Midatech Pharma total gross revenue increases to £0.58m

Midatech Pharma PLC (LON:MTPH), a drug delivery technology company focused on improving the bio-delivery and biodistribution of medicines, has announced its audited preliminary results for the year ended 31 December 2021.

2021 HIGHLIGHTS

Operational

· In June 2021, in an R&D update we announced:

o  Breakthrough data on the successful encapsulation of a biologic using Q-Sphera technology. We believe no other commercial or academic organisation has been able to successfully deliver therapeutic proteins over extended periods using methods capable of commercial scale up.

o  Delivery of proof of concept formulations of MTX214 and MTX216 to our collaboration partner Janssen for them to undertake in vivo studies.

o  Successful development of a long-acting formulation of MTD211 (Q-brexpiprazole) which, in in vivo studies, demonstrated that a single injectable dose could deliver therapeutic blood levels of brexpiprazole over a period of three months.

· In July 2021, we closed a Placing of 35.1m new ordinary shares with investors in the UK to raise gross proceeds of £10m (£9m net of expenses).

· In August 2021, we announced that the Company had moved its headquarters, including offices and custom built laboratories to new facilities at Caspian Point in Cardiff. The new premises were officially opened by Vaughn Gething MS, Welsh Government Minister for the Economy.

· In December 2021, we announced the successful completion of the 30-day FDA review period of our   Investigational New Drug Application for a planned Phase I study of MTX110 in recurrent Glioblastoma Multiforme.

Post period end

· In January 2022, we announced an extension of our R&D collaboration with Janssen. Under the extended collaboration we will focus on maximizing drug loading and optimizing in vitro duration of release for Janssen’s undisclosed experimental molecule using our Q-Sphera technology.

· In February 2022, we announced Janssen had added a second molecule to the collaboration with the same objectives of maximizing drug loading and optimizing in vitro duration of release.

Financial

· Total gross revenue⁽¹⁾ for the year of £0.58m (2020: £0.34m).

· Customer revenue⁽²⁾ for 2021 of £0.58m (2020: £0.18m).

· UK Placing in July 2021 raised £9.0m, net of expenses.

· Cash and deposits at 31 December 2021 of £10.06m (2020: £7.55m).

· Net loss from continuing operations of £5.46m (2020: £22.19m loss).

· Net cash inflow in the year of £2.52m (2020: £3.64m outflow).

· Tax credit receivable of £0.67m (2020: £1.16m).

	1.  Total gross revenue represents collaboration income from continuing operations plus grant revenue.
	2.  Customer revenue represents total gross revenue, excluding grant revenue.

INTRODUCTION

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.

STRATEGY

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 for panobinostat.

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.

BUSINESS MODEL

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.

Development

Our intention is to build a balanced portfolio of Q-Sphera programmes employing a bi-fold strategy to create an:

· internal pipeline of long-acting injectable products by re-formulating existing, approved therapies; and

· external pipeline by entering into research collaborations with partners to formulate their proprietary products into long-acting injectable products.

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 of the product.

Manufacturing

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 transfer agreement.

MTX110 is currently being manufactured to GMP standards at a CMO.

Commercialisation

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 royalty payments.

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 with Janssen:

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 actingInjectable	X	X
MTD219	Q-Sphera	Tacrolimus	Anti- transplant rejection	Long actingInjectable	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

TECHNOLOGIES

Q-Sphera

Technology

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.

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.

Pipeline

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.

MidaSolve

Technology

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.

MTX110

Using our MidaSolve technology in combination with panobinostat, an otherwise insoluble drug, MTX110 is designed for direct-to-tumour treatment of intractable brain cancers. Panobinostat is currently marketed under the brand Farydak® which is used orally in combination therapy for the treatment of multiple myeloma. We are currently researching the utility of MTX110 to proof of concept stage in three indications:

Glioblastoma Multiforme (GBM):

GBM is the most common and aggressive form of brain cancer in adults, usually occurring in the white matter of the cerebrum. Treatments include radiation, surgical resection and chemotherapy although, in almost all cases, tumours recur. There are approximately 2-3/100,000⁽¹⁾ population diagnoses of GBM per annum.   Survival with standard of care treatment ranges from approximately 13 months in unmethylated MGMT patients to approximately 30 months in highly methylated MGMT patients⁽²⁾.

Following IND approval in December 2021, we are in the process of planning for enrolment of patients in a Phase I exploratory study to assess the utility of MTX110 in recurrent GBM.

Diffuse Intrinsic Pontine Glioma (DIPG):

DIPG tumours are located in the pons (middle) of the brain stem and are diffusely infiltrating. Occurring mostly in children, approximately 1,000 patients⁽³⁾ worldwide are diagnosed with DIPG per annum and median survival is approximately 10 months⁽⁴⁾. There is no effective treatment since surgical resection is not possible.  The standard of care is radiotherapy, which transiently improves symptoms and survival.  Chemotherapy does not improve survival and one likely reason is that many anti-cancer drugs cannot cross the blood-brain barrier to access the tumour.

In October 2020, we reported the first-in-human study by the University of California, San Francisco (“UCSF”) of MTX110 in DIPG using a convection enhanced delivery (“CED”) system. The Phase I study established a recommended dose range for Phase II, a good safety and tolerability profile but also encouraging survival data in the seven patients treated.

We are in the process of planning for a Phase II study to confirm the safety and efficacy of MTX110 in DIPG.

Medulloblastoma:

Medulloblastomas are malignant embryonal tumours that start in the cerebellum. They are invasive and, unlike most brain tumours, spread through the cerebrospinal fluid  (“CSF”) and frequently metastasize to different locations in the brain and spinal cord. Treatments include resection, radiation and chemotherapy. Approximately 350 patients⁽⁵⁾ are diagnosed with medulloblastoma per annum and 3,800 people are living with the disease in the US. The cumulative survival rate is approximately 60%, 52%, and 47% at 5 years, 10 years, and 20 years, respectively⁽⁶⁾; however, recurrence is nearly always fatal with no established standard of care.

The University of Texas is undertaking a Phase I exploratory study in recurrent medulloblastoma patients using direct administration of MTX110 into the fourth ventricle, enabling it to circulate throughout the CSF.

(1)  American Association of Neurosurgeons

(2)  Radke et al (2019). Predictive MGMT status in a homogeneous cohort of IDH wildtype glioblastoma patients. Acta Neuropathologica Communications 7:89 Online: https://doi.org/10.1186/s40478-019-0745-z

(3)  Louis DN, Ellison DW, et al. The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary. Acta Neuropathol 2016; 131:803-820 

(4)  Jansen et al, 2015. Neuro-Oncology 17(1):160-166

(5)  Aboian et al (2018). Neuro-Oncology Practice, Volume 5, Issue 4, December 2018

(6)  Smoll NR (March 2012). “Relative survival of childhood and adult medulloblastomas and primitive neuroectodermal tumors (PNETs)”. Cancer. 118 (5): 1313-22

MidaCore

Technology

The MidaCore technology platform is based on ultra-small gold nanoparticle (GNP) drug conjugates, which at 2-4nm and among the smallest particles in biomedical use. They are composed of a core of gold salts decorated with an array of therapeutic and/or targeting ligands. The small size and multi-functional arrangement around the gold core underpin the ability to improve biodistribution and target tumour and/or immune sites.

MidaCore design and synthesis GNP technology enables the production of nano-medications, which we believe are five-to-tenfold smaller than any other delivery vehicle in medical use.

MTX114

Using MidaCore technology, we have developed a re-engineered version of methotrexate, an immuno-suppressant for topical application in psoriasis. If successful, MTX114 would be a topical formulation of methotrexate, thus avoiding the need for potentially toxic systemic administration. Pre-clinical data have shown that MTX114 normalises skin thickness in psoriatic skin models. We are continuing the pre-clinical development programme of MTX114 through an in vivo programme looking at the immuno-suppressive effect and local staining.

CHIEF EXECUTIVE’S REVIEW

Introduction

2021 was the first full year since the announcement of our Strategic Review in March 2020 and realignment of our strategy. We have consolidated operations in our new facilities in Cardiff, expanded our R&D pipeline to eight programmes, secured a world-class collaboration partner for two of those programmes and significantly expanded the opportunities for our technology with the successful encapsulation of proteins in Q-Sphera.

Execution on Realigned Strategy

The Strategic Review was a catalyst for a re-evaluation of our priorities in the context of available resources. We quickly pivoted away from a largely single focus on MTD201 towards a more broadly-based collaborative strategy. Our realigned strategy is focused on exploiting our technologies to develop multiple products to proof of concept stage before seeking partners to fund pivotal studies and take those products through to market. Our financial returns will come from development and sales milestone payments and, ultimately, royalties.

Our intention is to maintain a balanced portfolio of internal and external Q-Sphera projects. Internal projects are based on already marketed APIs. External projects may be proposed by partners and based on their proprietary APIs. We have secured two R&D collaborations with Janssen.

Similarly, our re-alignment of the MTX110 clinical programme to prioritise GBM, an opportunity 30-50 times the size of DIPG, significantly enhances the potential for that product.

We retain the capability to manufacture Q-Sphera products to non-GMP pilot scale in our laboratory in Cardiff. Following the closure of our Bilbao operations, we are working to technical transfer our process to a CMO for GMP manufacture of clinical trial supplies and commercial products.

The clarity of our realigned strategy and the simplification of the investment case enabled us to attract new investment in July which, in turn, allowed us to continue executing on our strategy.

Commercial Update

Our commercial strategy is gaining traction. In July 2020 we announced a collaboration with Janssen to explore the feasibility of applying our Q-Sphera technology to Janssen’s chosen APIs. Following our success in the encapsulation of an exemplar protein, we announced in January 2022 that Janssen has extended our collaboration to optimise the drug loading and in vitro dissolution of Janssen’s proprietary protein.

 In March 2022 we announced that Janssen had further extended the collaboration to include the optimisation of drug loading and in vitro dissolution of a second protein. It is reassuring to have a collaboration partner of Janssen’s status validate the work we are doing with Q-Sphera.

R&D Update

With the change in strategic emphasis towards collaborating and partnering at proof-of-concept stage, our R&D portfolio has evolved as follows:

Q-Sphera

Each of the APIs we have developed for our internal Q-Sphera pipeline was identified after a comprehensive evaluation of potential candidates. Both address large markets and, as first in class long-acting injectables, have the potential to offer significant clinical benefits compared with current therapies and, importantly for reimbursement, savings to the healthcare system.

MTD211 (Q-brexpiprazole)

We have successfully developed a long-acting formulation of brexpiprazole. In in vivo studies, MTD211 demonstrated that a single dose is expected to deliver therapeutic blood levels of brexpiprazole over a period of three months. Marketed 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. Sales of long-acting anti-psychotic products in 2020 were approximately US$5.7 billion² globally.

MTD219 (Q-tacrolimus)

We are refining the development of a long-acting formulation of tacrolimus. In in vivo studies, MTD219 indicated a single dose of MTD29 could deliver therapeutic blood levels of tacrolimus over a period of two to three weeks. Marketed under the brand name ProGraf® among others, tacrolimus is indicated for the prophylaxis of transplant rejection and is currently only available as a once- or twice-daily oral tablet. Tacrolimus has a relatively narrow therapeutic index with potential for negative clinical outcomes from over- or under-dosing. The steady, predictable pharmacokinetics characteristics of Q-Sphera could offer significant advantages to patients and payors. 

In June 2020 we announced, as part of an R&D Review, breakthrough data on the successful encapsulation of a protein using Q-Sphera technology. There are no approved long-acting injectable formulations of biologic products such as monoclonal antibodies (mAbs) or other high molecular weight proteins because they are delicate and easily de-natured in manufacture. We demonstrated encapsulation of an exemplar mAb and most importantly, were able to preserve the functional integrity and antigen binding in vitro. The Company believes no other commercial or academic organisation has been able to successfully deliver therapeutic proteins over extended periods using methods capable of commercial scaling. We believe these results could potentially 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 payors. In 2020, the top 10 mAbs recorded aggregate sales of US$74.9 billion¹ and all mAbs recorded sales of US$154 billion¹ globally.

We are collaborating with Janssen on two large molecule APIs to optimize their respective drug loading and in vitro dissolution profiles.

MidaSolve / MTX110

Employing our MidaSolve technology, MTX110 solubilises panobinostat, a histone deacetylase (HDAC) inhibitor currently used in the treatment of multiple myeloma. In a liquid formulation as MTX110, panobinostat can be delivered directly to a patient’s tumour under constant pressure via a catheter system (Convection Enhanced Delivery, or “CED”) thereby bypassing the blood-brain barrier and allowing for high drug concentrations and broader drug distribution in and around the tumour while simultaneously minimising systemic toxicity and other side effects.

During 2021, following receipt of promising pre-clinical data from tumour models and in vitro patient-derived cell lines, we re-prioritised our development of our, MTX110, in favour of GBM, potentially a very significant opportunity with annual diagnoses of 2-3/100,000 population and global market potential of US$3-5 billion . In December 2021 we announced the successful completion of the 30-day FDA review period of our IND has been judged safe to proceed with a Phase I study in recurrent GBM. Accordingly, we have begun has preparations for patient enrolment to begin mid-2022 with the possibility of initial progression-free survival data in a limited number of patients by the end of the year.

We initially began developing MTX110 for DIPG, the ultra-rare, highly aggressive and inoperable form of childhood brain cancer. We have an ongoing Phase I study in the US with two more patients required for completion. Thereafter, we plan to initiate a Phase II study in DIPG with safety and efficacy endpoints. We are also evaluating the utility of MTX110 in medulloblastoma in a pilot study at the University of Texas.

As announced in June 2020, we received a letter from counsel to Secura Bio Inc. (Secura Bio), the licensor of panobinostat and API component of MTX110, purporting to terminate the Company’s license to panobinostat. Secura Bio three times declined to withdraw its termination of the license. We received a further letter sent on behalf of Secura Bio dated in May 2021 purporting to terminate the Secura License Agreement a second time for alleged material breaches of the agreement, and demanding a non-exclusive, fully paid-up, royalty-free, perpetual license to Midatech’s MTX110 intellectual property. This demand was refused based upon, among other things, Secura Bio’s previous termination of the license in 2020. We continue to enjoy freedom to use panobinostat for research purposes and believe the relevant Secura Bio patents may marginally delay a launch of MTX110 for DIPG but not MTX110 for GBM.

MidaCore

For MTX114 we have deployed our GNP technology to engineer a formulation of methotrexate for the topical treatment of psoriasis. If successful, MTX114 would be a topical formulation of methotrexate, thus avoiding the need for potentially toxic systemic administration. Pre-clinical data have shown that MTX114 normalises skin thickness in mouse psoriatic skin models. There are estimated to be over 100 million⁽²⁾ people who suffer from psoriasis worldwide.

(1)  Global Data

(2)  Psoriasis.org

Financing

Following the positive news in our R&D Update announcement in June 2021, we raised £10 million gross proceeds through the issue of 35.1 million new ordinary shares via a UK Placing in July. The Company currently has funding, assuming zero incoming license fees, into the first quarter of 2023. The financing was a key strategic decision of the Board. The Board balanced the impact of dilution on existing investors with the opportunities for growth in shareholder value afforded by the fundraise.

COVID-19

In response to the pandemic and government imposed restrictions on movement, we have established a COVID-19 Task Force with the dual objectives of safeguarding the health and wellbeing of our staff members and monitoring the impact of COVID-19 on our vendors and collaborators. We have organised the layout of our offices and laboratories in Cardiff to permit, as far as reasonably practical, social distancing and allow employees to work safely in our offices and laboratories. Notwithstanding these actions, there has been disruption to internal workplans and delays in the recruitment of patients to ongoing clinical trials.

Outlook

The breakthrough data on the encapsulation of a protein using Q-Sphera and retention of its integrity over a significant period is, as far as we know, unique and could offer game-changing opportunities for Midatech Pharma. We believe we have reasons to view the future with confidence.