Biodexa CEO Issues Shareholder Letter Highlighting Progress in 2023 and Expected Milestones in 2024 - Seite 2

We are also in the process of setting up a Phase IIa study of tolimidone in approximately 16 patients with Type 1 diabetes. The study will be open-label with three tolimidone doses tested in parallel. The study will include measurement of C-peptide (a marker of insulin), HbA1c (a measure of plasma glucose levels) and number of hyperglycemic events. We expect to be able to announce preliminary data before the end of 2024.

MTX110

Recurrent Glioblastoma Multiforme

Our unique formulation of panobinostat in combination with Convection Enhanced Delivery direct to the tumor continued to advance in the clinic. Because we saw no drug-related adverse events during dose escalation, we were able to recruit the minimum number in the first cohort of patients in our Phase I study (called the MAGIC-G1 study) in recurrent glioblastoma multiforme, or GBM. GBM is the most common form of adult brain cancer with incidence of 3 -4 per 100,000¹ and overall survival of 13 to 30 months depending on numerous factors, including MGMT methylation². GBM universally recurs and, once recurred, median overall survival is approximately 6.5 months³. We expect to announce Progression Free Survival data on the first cohort of patients in mid-2024.

Diffuse Midline Glioma (formerly categorized as Diffuse Intrinsic Pontine Glioma, or DIPG)

Diffuse Midline Glioma, or DMG, is a fatal pediatric brain cancer with approximately 1,100 diagnoses per annum globally⁴ and overall survival of 8 to 10 months⁵. Building on our first Phase I study in DMG, which showed median overall survival of 26 months, recruitment of a second Phase I study at Columbia University was completed in mid-2023. We expect publication of results at a major conference around the end of the first quarter of 2024. Based on the combined results of the two Phase I studies, we will evaluate the potential for an IND for what could prove a pivotal Phase II study towards the end of the year.

MTD217

When under stress from chemotherapy, to generate energy, cancer cells often switch from aerobic glycolysis pathway to an alternative oxidative phosphorylation, or OXPHOS, pathway. In 2023 we initiated a preclinical program to explore the simultaneous inhibition of both aerobic and OXPHOS pathways and we have already been able to demonstrate up to a six-fold synergistic effect of co-administering MTX110 with an OXPHOS inhibitor in three patient-derived cells lines. We have also established new patent positions to protect these combinations. Our initial target for MTD217 is leptomeningeal disease, or LMD, a lethal complication in which metastatic cancer cells, most commonly from breast and lung tumors, invade the cerebrospinal fluid and central nervous system. Approximately 5% of all cancer patients develop LMD⁶ and, with no effective treatments currently available, median overall survival is just three to six months post- diagnosis⁶. In the fourth quarter of 2023 we set up and validated a mouse LMD model. We expect to report data from the in vivo LMD efficacy model by the end of the first quarter of 2024. If positive, we aim to open an IND before year end 2024 and start a first clinical study by the end of the first quarter of 2025.