VAL-083 Overview - VAL-083 is a first-in-class, small molecule, DNA-targeting agent with proven biological and tumor-effecting activity, and has prolonged life in a human brain tumor study[4] - The lead indication is biomarker-driven, MGMT-unmethylated glioblastoma multiforme (GBM), with three distinct GBM patient populations in Phase 2 studies[4] - The 505(b)(2) path allows the use of prior toxicology and clinical data from the National Cancer Institute and other studies to support FDA filings[4] - Fast Track Designation and Orphan Drug Designations have been granted in the US and EU[4] Clinical Development and Efficacy - A previous randomized trial at the National Cancer Institute (NCI) in 42 brain cancer patients showed that radiation only patients had a median overall survival (mOS) of 35 weeks, while radiation and VAL-083 patients had a mOS of 67 weeks[8] - In the newly-diagnosed study arm, 53% of patients assessed showed Complete Response, and 41% assessed showed Stable Disease[27] - In recurrent patients, 28% have been assessed as Stable Disease[24] Market Opportunity and Capital Management - The company spent only $40.5 million in shareholder capital to establish multiple clinical programs as of June 30, 2019[12] - The total quarterly burn is approximately $1.6 million[12] - GBM has an annual incidence of approximately 29,000 new cases in the US and EU[28] - There are >17,000 newly-diagnosed and adjuvant MGMT-unmethylated patients annually[28] - There are >12,000 recurrent MGMT-unmethylated patients annually[28]
DelMar Pharmaceuticals (DMPI) Presents At MicroCap Rodeo Investor Conference - Slideshow