Biodexa Pharmaceuticals plc · NASDAQ:BDRX
Biodexa Pharmaceuticals — Midatech Pharma — Investor Presentation (December 2022)
32 slides from Biodexa Pharmaceuticals's investor presentation, Dec 13, 2022
Slide 1: Investor Presentation November 2022
NASDAQ:MTP AIM:MTPH Investor Presentation November 2022
Slide 2: Important notice
2 The following presentation, including a hard copy of these slides, the information communicated during any delivery of the presentation and any question and answer session, and any document or material distributed at or in connection with the presentation (together, the “Presentation”), has been p
Slide 3: Risk factors
3 Investing in our securities includes a high degree of risk . You should consider carefully the specific factors discussed below, together with all of the other information contained in our SEC filings . If any of the following risks actually occurs, our business, financial condition, results of op
Slide 4: Acquisition Overview
4 • Midatech Pharma plc ( NASDAQ:MTP | AIM:MTPH ) has conditionally agreed to the terms of an acquisition of Bioasis Technologies Inc. ( TSXV:BTI ) to create a multi - asset rare and orphan disease drug company that will be renamed Biodexa Pharmaceuticals. Structure Stock - for - Stock Timing Antici
Slide 5: Combined Company Overview
5 • Focused on therapeutics for rare and orphan drug diseases in oncology and neurodegenerative disorders. • Clinical pipeline is enabled by a suite of delivery and therapeutic platforms. • Epidermal Growth Factor Therapeutics Aimed at treating rare neurodegenerative disorders • xB 3 Delivery Platfo
Slide 6: Clinical Pipeline
Clinical Pipeline 6 Product Preclinical Phase I Phase II Upcoming Catalysts MTX110 (to be renamed BDX110) Panobinostat • H1 2023 Phase II IND filing • H1 2023 First Patient First Visit • H2 2023 Cohort A data CRES101 1 (to be renamed BDX101 ) EGF1 - 48 DIPG (Diffuse Intrinsic Pontine Glioma) Gliobla
Slide 7: Strategic Partners Utilizing Midatech's and Bioasis' Delivery Platform
Partner Overview Platform(s) Indication(s) Proceeds Received Potential Future Proceeds 2020 revenue of USD$2.3B xB 3 • Four undisclosed lysosomal disorders • USD$3.0M • Up to USD$138M • Royalty on net sales NASDAQ:PRTA xB 3 • Undisclosed neurodegenerative disease • USD$1.0M • Up to USD$33M • Royalty
Slide 8: Anticipated Catalysts
Q2’ 23 Q3’ 23 Q4’ 23 Anticipated Catalysts 8 Q1’ 23 BDX110 rGBM First Patient F irst Visit (FPFV) BDX101 Commence GMP manufacture BDX102 Orphan Drug Designation filings GBS BDX110 Phase II DIPG IND submitted BDX103 Orphan Drug Designation filing CIDP EGF Platform presentation Symposium Molecular Med
Slide 9: BDX110
BDX110 CONFIDENTIAL – NOT FOR PUBLIC DISTRIBUTION
Slide 10: BDX110 Direct Delivery of Panobinostat
BDX110 Direct Delivery of Panobinostat • BDX110 • Direct delivery treatment of Panobinostat • Re - fillable pump implanted in abdomen • Delivers drug intra - tumorally to target location • Bypasses blood brain barrier • Opportunity to deliver maximal therapeutic dose • Minimises potential for system
Slide 11: Panobinostat: A promising therapy for DIPG
Panobinostat A promising therapy for DIPG (Brain Cancer in Children) • In a screen of 83 drugs panobinostat was among the most effective agents 1 • Convection - enhanced delivery (CED) to directly infuse panobinostat into the pons of a DIPG orthotopic xenograft model showed: • A marked effect on the
Slide 12: BDX110 Diffuse Intrinsic Pontine Glioma (DIPG)
BDX110 Diffuse Intrinsic Pontine Glioma (DIPG) • Significant unmet medical need • About 300 children diagnosed in the US pa 1 , over 1,100 worldwide 2 • Median survival of approximately 10 months • Resection not possible, no effective treatment 3 • Phase I programme: • ‘201 study (UCSF) n=7 showed:
Slide 13: BDX110 DIPG – Clinical Data
BDX110 Diffuse Intrinsic Pontine Glioma (DIPG) – Clinical Data 13 The median overall survival (OS) for cohort was 26.1 months (95% confidence interval) Median survival based on a cohort of 316 cases was 10.0 months 1 1. Jansen et al, 2015. Neuro - Oncology 17(1):160 - 166 CONFIDENTIAL – NOT FOR PUBL
Slide 14: BDX110 Glioblastoma (GBM)
• Problem: • Many drug failures due to poor BBB penetration • Potential Solution: • BDX110 is delivered intra - tumorally at high doses via CED, by - passing BBB • Compelling mechanism and preclinical evidence of efficacy in GBM models • Encouraging data from DIPG studies • Phase I (MAGIC – G1 study
Slide 15: BDX110 Glioblastoma (GBM) Background
BDX110 Glioblastoma (GBM) Background • Survival with standard of care treatment ranges from approximately 13 to 30 months depending on MGMT methylation. • Standard of care: resection, radiation, limited drug options • Near 100% recurrence • More than 13,000 GBM diagnoses pa in US 1 . • Global incide
Slide 16: BDX101 BDX102 BDX103
BDX101 BDX102 BDX103 CONFIDENTIAL – NOT FOR PUBLIC DISTRIBUTION
Slide 17: Epidermal Growth Factor (EGF) Platform
Epidermal Growth Factor (EGF) Platform Novel Treatment Approach For Neurodegenerative Disorders 17 • Epidermal Growth Factor (“ EGF ”) • Protein that stimulates cell growth and differentiation • Stimulates oligodendrocyte and Schwann cell differentiation and maturation for remyelination • Neurodegen
Slide 18: EGF Decreases Inflammation and Prevents Demyelination
EGF Decreases Inflammation and Prevents Demyelination • MOG - induced EAE (a model of MS) mouse brain demonstrated absence of any demyelination when treated with EGF ( Luxol fast blue stained sections of spinal cord). 18 • The staining with LFB shows the formation of demyelination plaques occurred i
Slide 19: EGF Effectively Treats Neuroinflammation in EAN
EGF Effectively Treats Neuroinflammation in EAN 19 • EAN is the animal model of CIDP and Guillain - Barre Syndrome. Nicoletti et al J Neuroimmunol . 2019 CONFIDENTIAL – NOT FOR PUBLIC DISTRIBUTION
Slide 20: BDX101 Optic Neuritis
BDX101 Optic Neuritis 20 • BDX101 is being developed for optic neuritis associated with multiple sclerosis to reduce demyelinating inflammation of the optic nerve. PREVALENCE/INCIDENCE MARKET 100,000 1 US Annual Incidence estimated at 6.4 per 100,000 2 Recent UK study demonstrated annual incidence o
Slide 21: Proposed Phase 2 Study Design BDX101 – Optic Neuritis
Proposed Phase 2 Study Design BDX101 – Optic Neuritis 21 BDX101 Phase 2 POC 1 - 5 Population ▪ 40 Design: ▪ 2 groups receiving either EGF 1 - 48 subcutaneously on alternate days daily for 10 days or placebo as an add - on therapy to standard methylprednisolone treatment (250mg every six hours) Prima
Slide 22: BDX102 Guillain-Barré Syndrome (GBS)
BDX102 Guillain - Barré Syndrome (GBS) 22 1. CDC 2. Journal of Neuroinflammation 3. Research and Markets PREVALENCE/INCIDENCE MARKET 3000 to 6000 people develop GBS every year in the US 1 150,095 total cases of GBS worldwide 2 in 2019 6.4% global increase in the age - standardized prevalence of GBS
Slide 23: BDX103 CIDP
BDX103 Chronic Inflammatory Demyelinating Polyradiculoneuropathy ( CIDP ) 23 • BDX103 is indicated for CIDP, a rare neurological disorder in which there is inflammation of nerve roots and peripheral nerves and destruction of the fatty protective covering (myelin sheath) of the nerve fibers. PREVALEN
Slide 24: xB Platform
xB 3 Platform CONFIDENTIAL – NOT FOR PUBLIC DISTRIBUTION
Slide 25: xB Platform
xB 3 Platform • xB 3 platform utilises the low - density lipoprotein - related protein 1 (LRP1) receptor • Carries payloads across the BBB via a process of endocytosis and transcytosis • Applicable to variety of actives including monoclonal antibodies, enzymes and oligonucleotides 25 Partners Utiliz
Slide 26: xB Platform vs. Other Blood Brain Barrier Technologies
xB 3 Platform vs. Other Blood Brain Barrier Technologies • The xB 3 Platform Technology delivers therapeutics across the blood - brain barrier to treat orphan and rare genetic diseases and has been demonstrated to outperform competing blood - brain barrier technologies. 26 Outperforms competing Bloo
Slide 27: Q-Sphera Technology Platform
Q - Sphera Technology Platform CONFIDENTIAL – NOT FOR PUBLIC DISTRIBUTION
Slide 28: Q-Sphera Technology Platform
Q - Sphera Technology Platform 28 • Q - Sphera is a polymer microsphere microtechnology used for sustained delivery to prolong and control the release of therapeutics over an extended period of time, from weeks to months. • Industrial printing technology reinvented • Controlled piezoelectric droplet
Slide 29: Pro-Forma Financials and Capitalization
Pro - Forma Financials and Capitalization CONFIDENTIAL – NOT FOR PUBLIC DISTRIBUTION
Slide 30: Pro-Forma Financials and Capitalization
30 Capitalization 2,3 ADS Equivalents ADS 7,524,289 Warrants ( WAEP USD$10.78) 1,784,136 Options ( WAEP USD$5.45) 584,110 Fully Diluted 9,892,535 Financial Overview As of June 30, 2022 Cash USD$8.2M Debt 1 USD$1.6M Pro - Forma Financials and Capitalization 1. Debt outstanding based on IFRS GAAP bala
Slide 31: Investment Summary
31 • Company focused on therapeutics for rare and orphan drug diseases in oncology and neurodegenerative disorders. • Clinical pipeline is enabled by a suite of delivery and therapeutic platforms. • Epidermal Growth Factor Therapeutics Aimed at treating rare neurodegenerative disorders • xB 3 Delive
Slide 32: Proposed Board of Directors
Proposed Board of Directors 32 Stephen Parker Chairman Stephen Stamp CEO/CFO Deborah Rathjen Non - executive Director Mario Saltarelli Non - executive Director Simon Turton Non - executive Director Mr. Stamp has held senior positions in a number of significant healthcare companies including as Group
Midatech Pharma — Investor Presentation (December 2022) on 6ix