Biodexa Pharmaceuticals plc · NASDAQ:BDRX
Biodexa Pharmaceuticals — IPO Roadshow (December 2023)
33 slides from Biodexa Pharmaceuticals's IPO roadshow presentation, Dec 7, 2023
Slide 1: Corporate Presentation December 2023
Corporate Presentation NASDAQ:BDRX December 2023 Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration Statement No. 333-274895 December 7, 2023
Slide 2: Disclaimer & cautionary language regarding forward-looking statements
Disclaimer & cautionary language regarding forward - looking statements The following presentation, including a hard copy of these slides/the talks given by the presenters, the information communic ate d during any delivery of the presentation and any question and answer session and any document or
Slide 3: Disclaimer & cautionary language (cont'd)
Disclaimer & cautionary language regarding forward - looking statements (cont’d..) The forward - looking statements contained in this Presentation (including assumptions, opinions and views of the Company or opini ons cited from third party sources) are subject to risks, uncertainties and other fact
Slide 4: Free Writing Prospectus
Free Writing Prospectus This presentation highlights basic information about the Company and the offering. Because it is a summary that has been prep are d solely for informational purposes, it does not contain all of the information that you should consider before investing in our Company. Exc ept
Slide 5: Risk factors
Risk factors 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, including the list of risk factors in the Risk Factors section of the Company's most
Slide 6: Risk factors (cont'd)
Risk factors (cont’d..) 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, including the list of risk factors in the Risk Factors section of the Comp
Slide 7: Biodexa Expanded Clinical Pipeline
Indication Preclinical Phase 1 Phase2 Next Milestone MTX 110 ( panobinostat ) Diffuse Midline Glioma IND for DMG Phase II submission Q3 - 2024 MTX 110 ( panobinostat ) Glioblastoma Initiation of cohort B Q4 - 2023 Tolimidone (Lyn Kinase activator) Type 1 Diabetes Initiation of Phase Ib dose - rangin
Slide 8: Anticipated catalysts
Q1’ 24 Q2’ 24 Q3’ 24 Anticipated catalysts 8 Q4’ 23 MTX110 Initiation of Cohort B of Magic - G1 study in rGBM Q4’ 24 CONFIDENTIAL – NOT FOR PUBLIC DISTRIBUTION Tolimidone Initiation of Phase Ib dose - ranging study in T1D Multiple pre - clinical data expected from MTD217 program Tolimidone Initiatio
Slide 9: Tolimidone in Type 1 Diabetes
Tolimidone in Type 1 Diabetes The potential to restore β - Cell Function
Slide 10: Type 1 vs Type 2 Diabetes
Type 1 vs Type 2 Diabetes Type 1 Diabetes • Primarily juvenile onset • An autoimmune process destroying pancreatic - cells • Reduced to no insulin production • Presence of autoantibodies • Not preventable • 10% of all DM patients Type 2 Diabetes • Usually late adult onset • (Partially) functional
Slide 11: Type 1 Diabetes Epidemiology and Market Size
Type 1 Diabetes Epidemiology and Market Size PREVALENCE/INCIDENCE MARKET 8.4 million People living with T1DM worldwide in 2021 1 500,000 New cases per year 1 Global T1DM market estimated at US$7.59bn in 2022 3 Prevalence of T1DM increases annually by 0.34% 2 CAGR of 7.6% forecast across 2023
Slide 12: Lyn kinase as target in T1D
Lyn kinase as target in T1D • Lyn is a tyrosine kinase signaling protein which modulates key intracellular functions such as proliferation, differentiation, apoptosis, migration and metabolism • In fat cells it increases utilization of insulin and thus decreases blood sugar without having an effect
Slide 13: Characterization of lyn kinase as a target
Characterization of lyn kinase as a target In mice with ‘switched off’ lyn kinase ( lyn knock - out mice) increased β - cell death is observed via apoptosis staining (shown in red below) At the same time, staining for active β - cells demonstrates decrease in their mass in lyn knock - out animals Da
Slide 14: Tolimidone: Potential to change the paradigm in Type 1 Diabetes
Tolimidone Potential to change the paradigm in Type 1 Diabetes Phase II ready small molecule lyn kinase activator demonstrated in preclinical studies significant increase in beta - cell survival. It benefits from a complete toxicology and safety study package in humans. 14 • Discovered by Pfizer in
Slide 15: Tolimidone effects in T1D mouse model
Tolimidone effects in T1D mouse model • Tolimidone increases β - cell mass by promoting their survival as demonstrated by insulin staining in the images below • β - cell function preservation may be due to a direct protective activity of tolimidone on the cells, or reduction of glucotoxicity Tolimid
Slide 16: Improved glucose control and islet health markers
Improved glucose control and improvement in islet health markers Improved glucose control in non - obese mouse model (NOS model) with preserved effect after treatment termination – protective effect of tolimidone Improvement in markers of islet health confirm protective effect of tolimidone Tolimido
Slide 17: Clinical development of tolimidone
Clinical development of tolimidone Phase Ib : • Phase I efficacy dose selection study to confirm Phase II dose. Safety data to be derived from earlier Pfizer/ Melior studies • N ≈ 12 - 15 patients, 3 - 4 dose/escalations • Runs in parallel with preparations for Phase II Phase II: • Aiming to open re
Slide 18: MTX110
biodexa pharmaceuticals MTX110
Slide 19: MTX110 Rationale for panobinostat
• 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 DMG orthotopic xenograft model showed: • A marked effect on the rate of DMG xenograft growth 1 • Significantly prolonged survival c
Slide 20: MTX110 Product concept
Delivered directly into tumor Drug bypasses blood brain barrier Re - fillable implanted pump Optimized Therapeutic Dose with Minimal Potential for Systemic Exposure MTX110 Product concept 20
Slide 21: MTX110 Diffuse Midline Glioma (DMG) Opportunity
MTX110 Diffuse Midline Glioma (DMG) Opportunity • Significant unmet medical need • About 300 children diagnosed in the US pa 1 , over 1,100 worldwide 2 • Median survival of 8 - 11 months 3 • Resection not possible, no effective treatment 4 • Phase I programme: • ‘201 study (UCSF) n=7 results publish
Slide 22: MTX110 DMG clinical data from study
MTX110 Diffuse Midline Glioma (DMG) – clinical data from 201 study 22 CONFIDENTIAL – NOT FOR PUBLIC DISTRIBUTION 1. Jansen et al, 2015. Neuro - Oncology 17(1):160 - 166 The median overall survival (OS) for cohort was 26.1 months (95% CI) Median survival based on a cohort of 316 cases was 10.0 months
Slide 23: MTX110 Glioblastoma (GBM) Opportunity
MTX110 Glioblastoma (GBM) Opportunity • 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 1 . • Standard of care: resection, radiation, limited drug options • Near 100% recurren
Slide 24: MTX110 Glioblastoma preclinical data
MTX110 Glioblastoma (GBM) preclinical data 24 • Problem: • Many drug failures due to poor BBB penetration • Potential Solution: • MTX110 is delivered intra - tumorally at high doses via CED, by - passing BBB • Compelling mechanism and preclinical evidence of efficacy in GBM models • Encouraging data
Slide 25: Transaction overview
Transaction overview Biodexa Pharmaceuticals PLC ( NASDAQ:BDRX ) has entered into conditional agreements with Melior Pharmaceuticals and Adhera Therapeutics Inc ( ATRX ) to acquire global rights to tolimidone - a Phase II ready asset for the treatment of Type 1 diabetes Building a portfolio of high
Slide 26: Transaction terms
1 Priced a t Offering Price, assumed to be $3.75 2 Assumes Adhera noteholoders subscribe $4MM in offering, otherwise $2MM 3. Priced at 10% discount to 5 - day VWAP or payable in cash Lock Up: 90 Days from Closing; Leak Out Agreement once resale registration statement declared effective. Consideratio
Slide 27: Pro-forma cap table
biodexa pharmaceuticals PRO-FORMA CAP TABLE 27
Slide 28: Pro-forma cap table
Pro - forma cap table Excluding F - 1 financing 28 BDRX has zero debt No Rachets or Resets 1. Assumes Adhera noteholders subscribe $4MM in offering at offer price of $3.75 per ADS 2. Melior / Bukwang to receive 9.9% of diluted in - the - money BDRX post F - 1 financing ADSs % WAV exercise price % Is
Slide 29: Biodexa value cycle
Biodexa value cycle 29 Identify attractive opportunities In license late preclinical to early clinical stage assets Generate financing to enable development Complete proof of concept clinical studies to add value Out licence prior to late stage clinicals
Slide 30: Appendix
biodexa pharmaceuticals Appendix 30
Slide 31: MTD217
biodexa pharmaceuticals MTD217 31
Slide 32: 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 develop 1 LMD • No effective treatments currently exist for LMD • With treatment,
Slide 33: MTD217 hypothesis and clinical approach
MTD217 hypothesis and clinical approach Literature suggests cancer cells in LMD exist in a metabolic equilibrium between adherent and floating states Hypothesis: Simultaneous OXPHOS inhibition (with water - soluble OXPHOS inhibitor) and glycolysis inhibition (with MTX110) may kill both floating and
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