Overview

We are a clinical pharmaceutical company focused on developing anti-cancer drug candidates for the treatment of brain and central nervous system (CNS) tumors. Our two lead drug candidates are TPI 287 and Berubicin.

TPI 287

• TPI 287 is an abeotaxane, a type of chemotherapy drug related to the taxane family.
• It has been granted Orphan Drug Designation by the FDA, which provides market exclusivity for 7 years upon approval.
• TPI 287 has shown promise in early-phase clinical trials for treating various cancers, including Glioblastoma, metastatic breast cancer, and lung cancer.
• Its key advantages are improved brain penetration and reduced susceptibility to drug resistance compared to earlier taxane drugs.

Berubicin

• Berubicin is an anthracycline, a powerful class of chemotherapy drugs.
• It was discovered at the University of Texas M.D. Anderson Cancer Center and initially licensed to Reata Pharmaceuticals.
• We obtained the rights to Berubicin through a series of transactions and have initiated a Phase II clinical trial to evaluate its efficacy in treating Glioblastoma Multiforme.
• The trial compares Berubicin to the current standard of care, Lomustine, in 252 patients. While the topline data did not show a statistically significant improvement in overall survival, the results suggest Berubicin may have potential value as a treatment for Glioblastoma.

Financial Performance

Table 1: Financial Highlights

• General and administrative expenses decreased slightly due to lower stock-based compensation and marketing costs, offset by higher legal, professional, and travel expenses.
• Research and development expenses increased significantly due to costs associated with the Berubicin clinical trial data preparation and analysis.
• The net loss grew by 21.3% year-over-year, driven by the higher R&D costs and license fees related to the Cortice Agreements.

Liquidity and Capital Resources

• As of March 31, 2025, the company had $13.0 million in cash and $10.9 million in working capital.
• During Q1 2025, the company raised $9 million through an at-the-market (ATM) equity offering program, bringing the total raised under the ATM to $22.8 million.
• Subsequent to Q1, the company completed a $4.5 million public offering, providing additional capital.
• The company estimates it has sufficient capital to fund operations into the second half of 2026, which should allow it to initiate a trial of TPI 287 and complete the Berubicin trial.
• However, significant additional financing will be required to bring TPI 287 through regulatory approval, as the company does not currently have a firm trial design and associated cost estimates.

Outlook

• The company faces uncertainty around the future development of Berubicin, as the recent trial did not meet the primary endpoint of statistically significant improvement in overall survival.
• Securing additional capital through equity or debt financing will be crucial to advancing the company’s pipeline, particularly the TPI 287 program, which has shown promise but requires further clinical development.
• The company will need to carefully manage its cash runway and explore all options to fund its operations and drug development activities going forward.