MTP Stock Price Increases Over 35% Pre-Market: Why It Happened

By Amit Chowdhry ● Jun 17, 2021
  • The stock price of Midatech Pharma plc (NASDAQ: MTP) increased by over 35% pre-market. This is why it happened.

The stock price of Midatech Pharma plc (NASDAQ: MTP) – an R&D biotechnology company focused on improving the bio-delivery and biodistribution of medicines – increased by over 35% pre-market. Investors are responding positively to the company announcing breakthrough in vitro data that demonstrate Q-Sphera’s potential to formulate proteins into long-acting injectable products, as well as significant progress across multiple other programs.

In the 13 months since the announcement of a Strategic Review, Midatech Pharma has shut down its Bilbao operations, thus halving its monthly cash burn rate and pivoted from a largely singular focus on one Phase III ready asset (MTD201, Q-Sphera octreotide) to ‘multiple shots on goal’ with an expanded pipeline of 9 earlier stage programs. And the company’s strategy is to develop each program to proof of concept before seeking licensing partners to undertake later-stage development, manufacturing, and commercialization.

Q-Sphera pipeline

The company’s 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 that release drug over predictable, sustained periods from one week to several months. Including:

Monoclonal antibody (mAb) formulation

There are no approved long-acting injectable formulations of biologic products like mAbs or other high molecular weight proteins since they are delicate and easily de-natured in manufacture. And the company has been working on an exemplar mAb and thus far, has demonstrated encapsulation of the mAb and most importantly, preservation of functional integrity and antigen binding in vitro. The company said it believes no other commercial or academic organization has been able to successfully deliver therapeutic proteins over extended periods using methods capable of commercial scaling.

The company believes these results may potentially open up very significant opportunities for its Q-Sphera technology. And 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. Last year, the top 10 mAbs recorded aggregate sales of US$74.9 billion1 and all mAbs US$154 billion globally.

The next steps for the company will be to further optimize the drug loading and dissolution profile for encapsulated mAbs. In parallel the company will seek to replicate the data seen in this exemplar mAb and is evaluating multiple high value mAb therapeutics for addition to its internal pipeline.

MTX214 and MTX216

Both MTX214 and MTX216 are being developed under collaboration agreements with the European affiliate of a global healthcare company. And the company has manufactured and delivered proof of concept formulations of MTX214 and MTX216 to the collaboration partner who, in turn, is expected to begin dosing for in vivo studies in the next few weeks.

MTD211

As part of its internal pipeline, the company successfully developed a long-acting formulation of brexpiprazole. And in in vivo studies, MTD211 was well tolerated and demonstrated that a single dose of MTD211 is expected to deliver therapeutic blood levels of brexpiprazole over a period of 3 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. And sales of long-acting anti-psychotic products in 2020 were approximately US$5.7 billion globally.

The company initiated discussions with third parties about a potential licensing of MTD211. And there can be no assurance on the timing for concluding these discussions nor any assurance that the parties will enter into definitive agreements.

MTX110

MTX110 — a novel 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 pre-IND meeting with the FDA on 15 June 2021, the company is expecting to initiate a Phase II study in DIPG later this year. This study will be open label, single arm, in 21 newly diagnosed patients. And administration of MTX110 will be via convection enhanced delivery (CED) over 48 hours in 6 cycles, 2 to 4 weeks apart. The primary endpoints will be safety, tolerability and overall survival at 12 months (OS12). Approximately 1,000 patients globally are diagnosed with DIPG per annum and median survival is approximately 10 months.

Building on the in vivo data that were presented at the 2020 annual meeting of The Society of Neuro-Oncology which demonstrated the efficacy of MTX110 against 2 GBM cell lines in an ectopic tumor model, the company has recently demonstrated the potency, at therapeutic concentrations, of MTX110 against a further 4 patient-derived GBM cell lines in vitro. The company is planning a Phase I pilot study in GBM to begin enrollment later this year. There are GBM diagnoses of 2 to 3 per 100,000 population per annum and survival ranges from 13 to 30 months depending on MGMT methylation.

Along with the announcement made in June 2020, the company has received a further communication from counsel to Secura Bio, the owner of panobinostat patents that were formerly licensed to the company. Secura Bio had terminated the company’s license to the patents in June 2020. 

Notwithstanding that termination, Midatech Pharma recently received a letter from Secura Bio claiming material breach of the terms of the license and is demanding, among other things, that the company grant Secura Bio a non-exclusive, free license to its intellectual property and know-how. Midatech Pharma believes that such claims and demands are without any merit.

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 the COVID-19 pandemic. But there can be no assurance on the timing for concluding the discussions nor any assurance that the parties will enter into definitive agreements.

Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.