MediciNova (MNOV) investor relations material

Key clinical programs and catalysts

• Two major clinical readouts are expected: MN-001 in September and COMBAT-ALS by year-end, with both trials fully enrolled and focused on high unmet medical needs.

• MN-166 (ibudilast) is the core ALS program, targeting neuroinflammation and neuroprotection, with a pivotal phase II-B/III trial (COMBAT-ALS) in early-stage ALS patients; top-line data is anticipated by year-end.

• MN-001 targets hypertriglyceridemia, type 2 diabetes, and NAFLD; a phase II trial with 40 patients is set to report top-line results in September, aiming to confirm prior metabolic signals.

• Additional pipeline programs in oncology and acute lung injury are externally funded, providing optionality without requiring shareholder capital.

• Expanded access and government-funded studies, such as the $22 million ALS program at Mayo Clinic, further support the ALS franchise.

Financial position and operational model

• Cash balance at end of Q2 2026 was $25.4 million, with an annual operating burn of $12–13 million and no debt or warrants.

• Current cash is expected to fund operations through both key clinical milestones, reducing immediate financing risk.

• Lean management structure and external funding for non-core programs help preserve capital and operational flexibility.

• Potential partnership transactions are being explored to further extend cash runway.

• Dual listing on Nasdaq and Tokyo Stock Exchange enhances access to capital markets.

Strategic outlook and differentiation

• MN-166 is positioned for a broad ALS population, not limited to genetic subtypes, and offers an oral formulation.

• Orphan Drug Designation in the U.S. and Europe, plus Fast Track status in the U.S., support regulatory strategy.

• Competitive landscape is shaped by recent drug withdrawals, highlighting the need for new ALS therapies with meaningful clinical benefit.

• Upcoming data readouts are expected to drive principal valuation events and inform future partnering or development decisions.

• Multiple shots on goal from non-core programs provide additional upside potential.