NovAccess is a pre-revenue biopharmaceutical company developing an immunotherapy for glioblastoma, the most common and lethal primary brain tumor in adults. NovAccess' lead candidate, TLR-AD1, is a dendritic cell-based vaccine that uses a patient's own tumor cells and immune cells to generate an anti-tumor immune response. After surgery, a patient's tumor cells are harvested and mixed with the patient's own dendritic cells outside the body, activating them to recognize the tumor; these activated cells are then reinjected into the patient to trigger the immune system to destroy remaining cancer cells. NovAccess has not yet begun human clinical trials and plans to submit an IND application to the FDA in 2026 to initiate Phase I or Phase IIa trials. The company funds operations through capital raises and loans. NovAccess' intended business model is licensing — rather than commercializing TLR-AD1 directly, NovAccess plans to license TLR-AD1 and its broader patent portfolio to larger biopharmaceutical companies. NovAccess holds an exclusive license from Cedars-Sinai covering TLR ligand adjuvant patents in brain tumor vaccine therapy, and has also filed patents on the IDH1 protein as a biomarker to predict which patients are most likely to respond to dendritic cell immunotherapy. NovAccess has received orphan drug designation from the FDA for TLR-AD1, which provides tax credits, fee exemptions, and up to seven years of post-approval marketing exclusivity.