Biodexa Pharmaceuticals plc · NASDAQ:BDRX
Biodexa Pharmaceuticals — Bio International 2023
25 slides from Biodexa Pharmaceuticals's conference presentation, June 2023
Slide 1: Bio International
Bio International Boston – June 2023
Slide 2: Disclaimer
Disclaimer The following presentation, including a hard copy of these slides/the talks given by the presenters, 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
Slide 3: Biodexa Pharmaceuticals Overview
Biodexa Pharmaceuticals Overview Clinical stage biopharmaceutical company Currently focussed on treatments for rare primary and metastatic cancers of the brain Publicly traded NASDAQ: BDRX Headquartered in UK About 15 employees based out of facilities in Cardiff, South Wales 3
Slide 4: Our Team
Our Team Dmitry Steve Ellul Stephen Stamp Zamoryakhin VP Business Chief Scientific Development CEO/CFO Officer Fiona Sharp Dan Palmer Group VP Financial Technology Controller 4
Slide 5: Development Pipeline
Development Pipeline Indication Preclinical Phase 1 Phase2 Phase3 MTX110 Diffuse Midline (panobinostat) Glioma Glioblastoma Medulloblastoma MTD217 (Panobinostat + Leptomeningeal OXPHOS Disease inhibitor)
Slide 6: Company Strategy
Company Strategy BUILD DEVELOP PARTNER Acquire portfolio of assets Validate assets through License out to pharma focussed on the oncology / proof of principle studies in partners rare orphan space humans Partners to sponsor phase Target assets in late pre- Progress through to 3 programme and clinica
Slide 7: MTX110
MTX110 Intratumoral Panobinostat for Treatment for Brain Cancers
Slide 8: Why Panobinostat?
Why Panobinostat? • In a screen of 83 drugs panobinostat was among the most effective agents1 • Convection-enhanced delivery (CED) to directly infuse panobinostat into the pons of a DMG orthotopic xenograft model showed: • A marked effect on the rate of DMG xenograft growth1 • Significantly prolonge
Slide 9: MTX110 Product Concept
MTX110 Product Concept Optimised Therapeutic Dose with Minimal Potential for Systemic Exposure Delivered directly Drug bypasses into tumour blood brain barrier Re-fillable implanted pump
Slide 10: MTX110 Diffuse Midline Glioma (DMG)
MTX110 Diffuse Midline Glioma (DMG) • Significant unmet medical need • About 300 children diagnosed in the US pa1, over 1,100 worldwide2 • Median survival of approximately 10 months [ref] • Resection not possible, no effective treatment3 • Phase I programme: • ‘201 study (UCSF) n=7 showed • ‘203 stu
Slide 11: MTX110 DMG – Clinical Data
MTX110 Diffuse Midline Glioma (DMG) – Clinical Data 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 months1 1. Jansen et al, 2015. Neuro-Oncology 17(1):160-166 11
Slide 12: MTX110 Glioblastoma (GBM) Background
MTX110 Glioblastoma (GBM) Background • Most common and aggressive form of brain cancer in adults • 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 •
Slide 13: MTX110 Glioblastoma (GBM)
MTX110 Glioblastoma (GBM) 1400 Control TumVolume (mm3) 1200 MTX110 • Problem: 1000 800 • Many drug failures due to poor BBB penetration 600 400 • Potential Solution: 200 0 • MTX110 is delivered intra-tumorally at high doses via 0 5 10 15 Days 20 25 30 35 40 CED, by-passing BBB Figure 1. Tumour volum
Slide 14: MTX110 Medulloblastoma Background
MTX110 Medulloblastoma Background • Cancerous brain tumour that starts in the cerebellum in the lower back part of the brain • Most common cancerous brain tumour in children • Accounts for 20% of childhood brain tumours • 5-year relative survival rate for children age 14 and younger of 72% • About 5
Slide 15: MTD217 Leptomeningeal Disease (LMD) Background
MTD217 Leptomeningeal Disease (LMD) Background • Cancer in the cerebrospinal fluid and leptomeninges caused by metastases • Most commonly arises from breast and lung cancers • Approximately 5% of people who have cancer develop1 LMD • No effective treatments currently exist for LMD • With treatment,
Slide 16: Corporate Milestones
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Slide 17: MTX110 Milestones - 2023
MTX 110 Milestones - 2023 Phase 1 ‘203 study FPFV in Phase 2 data in DMG study in DMG Q1 Q3 Phase 2 IND in MAGIC-G1 study DMG submission cohort A PFS data DSMB clearance to escalate dose in MAGIC-G1 study MAGIC-G1 study cohort A PFS data Q2 Q4
Slide 18: Cap Table
Cap Table Excersize Date Excersize Price Shares ADS's in issue 18,925,882 Warrants Oct-19 $ 4.00 30,000 Oct-19 $ 125.00 1,499 May-20 $ 4.00 32,550 May-20 $ 41.00 33,357 May-20 $ 41.25 1,476 May-20 £ 34.00 70,000 Sep-22 £ 13.50 3,333 Feb-23 $ 0.0004 1,710,005 Stock Options WAV Exercise Price Shares B
Slide 19: Backup
biodexa pharmaceuticals e Backup
Slide 20: MTX110-V0024P Inhibition of HDAC by MTX110
MTX110-V0024P Inhibition of HDAC by MTX110 Activity of MTX110 was assessed against HDAC class I/II in ThP cell line in vitro, followed by assessing MTX110 activity against specific HDAC isoforms (1-11) in IC50 MTX110-10.9nM vitro and panobinostat DMSO 2.61nM against HDAC Class I/II enzymes demonstra
Slide 21: MTX110-V0287P Cytotoxicity in DMG Cell Lines
MTX110-V0287P Cytotoxicity in DMG Cell Lines The cytotoxicity effects of MTX110 +/- gadolinium in a range of patient derived • MTX110 was cytotoxic with IC50 values in the low nM DIPG and HGG cells. range, across a range of DIPG and GBM cell lines, with varying mutation status profiles Cell lines we
Slide 22: MTX-110 in vivo DIPG and GBM models
MTX-110 in vivo DIPG and GBM models
Slide 23: MTX110-R0288P Efficacy in an orthotopic DIPG Rat Model
MTX110-R0288P Efficacy in an orthotopic DIPG Rat Model • CED infusion of MTX110 @100µM twice weekly extended survival to 64 days compared with 52 days in control group (p<0.037). Six-week-old male athymic rats were injected intracranially with SF8628-luc DIPG cell suspensions and tumour growth measu
Slide 24: MTX110-M0221P Efficacy in an ectopic GBM Mouse Model
MTX110-M0221P Six-week-old male and female athymic mice (BALB/c Efficacy in an ectopic GBM Mouse Model (nu/nu) were injected subcutaneously at an injection volume of 50 μL with D08-0308MG cells (IDH1 WT). • Systemic administration of MTX110 resulted in non significant extensions in survival in an ID
Slide 25: MTX110-R0250K Distribution of MTX110 after single CED administration
MTX110-R0250K Distribution of MTX110 after single CED administration Brain panobinostat was highest in the convected region of the brain. Concentrations declined after cessation of CED with a calculated half life of 2h. Brain panobinostat concentrations were measured (n = 3/time) at time 0, 2, 4, 8