By David Bautz, PhD
READ THE FULL MTP RESEARCH REPORT
Business UpdateMidatech Pharma Plc (MTP) is a biotechnology aggregation with three atypical biologic commitment technologies that all advance bio-distribution and bio-delivery of drugs. The technologies accomplish this via either the targeted delivery, abiding release, or solubilized bounded commitment of absolute ameliorative drugs.
The Q-Sphera™ next-generation abiding absolution (SR) technology platform, with abundant and audible advantages over acceptable polymer microsphere production, utilizes absolutely and consistently bogus monodispersed micro particles such that alive biologic compounds are appear into the anatomy in a deeply controlled and anticipated abode over an continued aeon of time (e.g., weeks to months).
The MidaCore™ technology belvedere is based on gold nanoparticle (GNP) biologic conjugates, which at 2 nm are amid the aboriginal particles in biomedical use. They are composed of a amount of gold atoms amidst by a band of carbohydrates and linkers for adapter of baby molecules (e.g., chemotherapeutics, peptides, etc.) and targeting agents. The baby admeasurement and multi-valency adjustment about the gold amount affirm the adeptness to advance biodistribution and appropriately assurance and adeptness of absolute drugs.
The MidaSolve nanosaccharide admittance (NI) technology is activated for almighty baby atom chemotherapeutics that accept basal solubility at biological pH, which banned them to articulate administration. Back reformulated with the MidaSolve technology, the complexed molecules solubilize such that parenteral routes of administering can be employed. This enables bounded administering anon into the tumor.
Proposed Auction of Midatech Pharma US Inc.On September 27, 2018, Midatech appear the proposed auction of Midatech Pharma US Inc., which runs the company’s U.S. bartering operations, for an upfront acquittal of $13 actor and the abeyant for up to $6 actor in added application based on net sales of assertive Midatech US accessories in 2018 and 2019. Aloft achievement of the sale, Midatech is appropriate to accord the outstanding antithesis of the accommodation from MidCap Banking of $7.0 actor added accommodation costs and added fees, appropriately abrogation about $4.5 actor in proceeds. The denial of the company’s U.S. bartering operations is actuality undertaken to acquiesce all assets to be activated for the advance of the company’s advance development products, which are apparent in the amount below. The transaction is accidental aloft actor approval and we ahead it closing in the fourth division of 2018.
View Exhibit I
Positive Acting Abstracts for MTD201On August 31, 2018, Midatech appear absolute acting after-effects from a proof-of-concept abstraction for the company’s advance development artefact MTD201 (Q-octreotide), a abiding absolution artefact of octreotide that utilizes the company’s Q-Sphera™ abiding absolution technology.
This aboriginal in-human, bifold blind, randomized, alongside accumulation abstraction enrolled 24 advantageous volunteers and was advised to analyze the abiding absolution contour amid MTD201 and Sandostatin® LAR® (SLAR) both pharmacokinetically (PK abstracts on octreotide levels in the blood) and pharmacodynamically (PD abstracts on advance hormone biomarker levels).
Results showed that MTD201 produces a favorable analytic contour and potentially bigger artefact compared to Novartis’ SLAR. The afterward amount shows boilerplate claret octreotide levels for the capacity administered SLAR and MTD201. Interestingly, MTD201 has a bland uptake and aisle with about no antecedent “burst” appearance or dosage dumping, while SLAR has ailing controlled bimodal absolution kinetics characterized by two peaks over the aboriginal 7 canicule afore the artefact accomplish down, as apparent in the afterward figure.
View Exhibit II
The ample absurdity confined axiomatic for the SLAR abstracts shows the aerial airheadedness of claret octreotide release, which is in abrupt adverse to the actual baby absurdity confined for the MTD201 data. This is exemplified in the afterward graphs that shows claret octreotide levels for anniversary subject. Afterward the antecedent access phase, claret octreotide levels in those administered SLAR alter by up to 100-fold. The graphs for anniversary accountable administered MTD201 are consistent, deeply grouped, and linear, which is in abrupt adverse to the capricious and capricious graphs for those administered SLAR.
View Exhibit III
The afterward amount shows the boilerplate akin of claret octreotide over 63 canicule for those administered MTD201 and SLAR. The claret akin of octreotide for those administered MTD201 steadily rises, settles at a plateau for the continuance of the analysis period, afresh boring tapers off, while the claret akin of octreotide peaks at about day 1, afresh at day 5, and afresh tapers off for those administered SLAR.
View Exhibit IV
These differences in claret octreotide akin amid those administered MTD201 and SLAR translates into differences in the analytic aftereffect of advance hormone reduction, the anatomy afflicting acromegaly patients. As allotment of the trial, advantageous volunteers were accustomed advance hormone absolution hormone (GRHR) and the % abridgement in advance hormone (GH) akin was recorded afterward administering of MTD201 or SLAR. The afterward table shows that MTD201 resulted in at atomic commensurable normalization of GH levels and conceivably alike a greater abridgement as advised by the breadth beneath the ambit (AUC) and Cmax.
View Exhibit V
Additional appearance in which MTD201 may be aloft to SLAR include:
1) A faster reconstitution time (10 min for MTD201 vs. 40 min for SLAR); 2) Added time to use the artefact (up to two hours column reconstitution for MTD201 vs. defective to use anon column reconstitution for SLAR);3) The adeptness to use a abate barometer aggravate (21G aggravate acclimated to administrate MTD201 vs. 19G aggravate acclimated to administrate SLAR, although sometimes an 18G aggravate charge be acclimated due to blockages of 19G needles)
The aftermost point aloft was exemplified by the actuality that compared to SLAR, those administered MTD201 had abundant lower ante of affliction at bang armpit (8% vs. 25%) and bang armpit amore (8% vs. 83%).
The aggregation will be affair with the FDA to get acknowledgment on the aing analytic trial, and based aloft this advice the aggregation will adjudge whether to go for an adequation characterization or a differentiated label. The accommodation about which characterization to ambition will be dictated by the quickest avenue to approval and we abide to accept an NDA will be filed in 2020.
Q-Sphera™ OverviewThe Q-Sphera™ belvedere was advised to abode several problems associated with microencapsulation and polymer-depot based biologic delivery. The aerial activity reactor-based chrism processes such as those acclimated to accomplish SLAR crave a ample basement and are added careless in that they aftermath ample quantities of abstract particles (i.e., either too ample or too small). In addition, these chrism processes use ample volumes of abortive amoebic solvents (such as ethyl acetate and dichloromethane). Particles produced from these bread-and-er solutions charge be anxiously evaporated and done to aish antithesis traces of solvent. The ‘printer’ access MTP takes is different in that it ‘prints’ the microspheres at several actor spheres per second, uses non-toxic solvents calmly removed via extraction, and is completed in a baby infrastructure. The key advantage that the Q-Sphera™ access offers is artefact monodispersity and geneity. Actual bound atom admeasurement distributions can be produced, which increases the accessible artefact crop and leads to an bigger analytic contour and injectability characteristics compared to acceptable accomplishment methods. For example, the Q-Sphera™ belvedere after-effects in accessories with the abridgement of a access phase, lower variability, and bargain bang armpit affliction (as apparent in the after-effects from the MTD201 proof-of-concept study) through the use of abate barometer all-overs accustomed by the constant atom sizes. The end aftereffect of the Q-Sphera™ action is a conception that produces constant and reproducible biologic concentrations in the anatomy aural actual attenuated limits.
MTX110 Abstraction UnderwayOn May 25, 2018, Midatech appear that dosing has commenced in the abstraction of MTX110 for the analysis of broadcast built-in pontine glioma (DIPG), a awful infiltrative brainstem aerial brand glioma that occurs mostly in children. The tumors are aggressively infiltrative such that blight tissue about cannot be differentiated from accustomed academician tissue. The all-embracing average adaptation of accouchement with DIPG is about 9 months and charcoal banausic admitting decades of analytic balloon research.
The balloon is a accumulated Appearance 1 and 2 abstraction that will accept up to about 40 patients. The Appearance 1 assurance allocation of the abstraction is advanced on agenda and could potentially complete in aboriginal 2019.
View Exhibit VI
The alive basic of MTX110 is the ailing acrid hydroxamic acerbic biologic panobinostat, a histone deacetylase inhibitor (HDACi), which until afresh could not be formulated for parenteral administration. Midatech’s MidaSolve technology enabled the aqueous solubility of this chic of baby atom blight therapeutic, which expands parenteral commitment options that in about-face are accepted to advance the assurance and adeptness of the treatment.
Panobinostat does not cantankerous the blood-brain barrier finer back accustomed orally, appropriately necessitating an alternating agency of delivery. Direct commitment of MTX110, the acrid anatomy of panobinostat, bypasses the claret academician barrier and ensures able biologic acknowledgment to bump cells. This occurs through convection-enhanced commitment (CED), a adjustment acclimated to bear drugs into the academician through a burden acclivity in adjustment to bathe the extracellular aqueous alcove (Bobo et al., 1994). In adverse to diffusion, which depends absolutely aloft a absorption acclivity to administer the molecules, the use of hydraulic burden in CED allows for akin administration over ample distances by displacing the interstitial fluid.
To date, MTX110 has been acclimated on a compassionate use base to amusement bristles DIPG patients, area the biologic was able-bodied tolerated. Treating DIPG represents a abeyant $50-$100 actor common befalling based on the accessible accommodating citizenry and abeyant for drop biologic pricing.
Financial UpdateOn September 27, 2018, Midatech appear banking after-effects for the aboriginal six months of 2018. Total acquirement from continuing operations for the aboriginal six months of 2018 was £0.55 million, compared to £0.47 actor for the agnate time aeon in 2017. Analysis and development costs were £4.6 actor for the aboriginal bisected of 2018, compared to £4.2 actor for the aboriginal bisected of 2017. The access was primarily due to analytic balloon costs for MTD201 and MTX110 that were not incurred during 2017. Administering costs for the aboriginal bisected of 2018 were £2.1 million, compared to £2.7 actor for the aboriginal bisected of 2017.
Total banknote bake for the aboriginal bisected of 2018 was £8.4 actor and the aggregation exited the aboriginal bisected of 2018 with about £4.4 actor in banknote and banknote equivalents. We accept the company’s accepted banknote position, forth with the net gain from the auction of Midatech U.S., will be abundant to armamentarium operations through the aboriginal division of 2019.
ValuationMidatech’s three proprietary biologic commitment technologies (Q-Sphera™ for abiding absolution of already marketed products, MidaCore™ gold nanoparticles (GNP) for targeted delivery, and MidaSolve nanosaccharide admittance (NI) for bounded delivery) advice differentiate it from added biotechnology companies and the abeyant quick aisle to bazaar for MTD201 and MTX110 could bear cogent revenues alpha in aloof a few years. We appearance the auction of the bartering accumulation in the U.S. as a acute move by administration such that assets can be absolutely focused on advancing the activity candidates advanced to bazaar as bound as possible.
The acting after-effects from the proof-of-concept abstraction of MTD201 are absolutely auspicious and the abeyant for the artefact to be an advance over SLAR is abrupt and increases the abeyant for the Q-Sphera™ platform. Our appraisal currently stands at $5.50 per share, and with the banal currently trading at a abundant abatement to our accepted appraisal we accept investors would be able-bodied served to booty a afterpiece attending at the aggregation afore this appraisal gap closes as added investors become accustomed with the story.
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