KalVista Pharmaceuticals Highlights Strategic Plans for Coming Fiscal Year

KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced its strategic plans for fiscal year 2025, beginning May 1, including for sebetralstat, the Company’s investigational novel, oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE).

“2024 has been an exciting and busy year for KalVista, as we achieved key milestones with our positive phase 3 KONFIDENT data and the completion of a substantial financing,” said Ben Palleiko, Chief Executive Officer of KalVista. “For the coming fiscal year, we have set a high bar as we finalize multiple regulatory filings for sebetralstat and plan for rapid commercialization upon approval. Given the scale of that opportunity, we will focus our resources on activities that support the launch, enabling sebetralstat to become the leading on-demand therapy for all people living with HAE and allowing us to work towards positive cash flow within the first few years of commercialization.”

Fiscal Year 2025 Strategic Plans:

Regulatory filings and commercial partners for sebetralstat, to support global launch plans

• New Drug Application submission to US FDA planned for June 2024
• Market Authorization Application submissions to both European Medicines Agency and UK MHRA planned for Q3 2024
• JNDA submission to Japanese Pharmaceuticals and Medical Devices Agency planned for Q4 2024
• Regulatory review timelines enable potential launches of sebetralstat in these territories in calendar 2025 and early 2026
• To enable the broadest possible global launch, we intend to engage commercial partners in certain international markets, targeting to select initial partners over the course of 2024

Continued lifecycle extension activities for sebetralstat, to grow the market opportunity

• Commence pediatric trial (KONFIDENT-KID) in Q3 2024, using an orally disintegrating tablet (ODT) formulation developed specifically for pediatric use. If approved, sebetralstat would be the first oral therapy in pediatric patients under age 18. In addition, sebetralstat would be only the second FDA-approved on-demand therapy of any type in this population
• Conversion of adolescent and adult participants in the ongoing KONFIDENT-S study to an ODT formulation in Q4 2024, enabling a potential 2026 sNDA approval. If approved, the ODT formulation would provide people living with HAE with an additional novel option for oral on-demand treatment

Resources focused on sebetralstat for on-demand HAE with goal of positive cash flow