KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary Angioedema Page 1

KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for sebetralstat, a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adult and pediatric patients 12 years of age and older. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of June 17, 2025. If approved, sebetralstat would be the first oral, on-demand treatment for HAE in adult and pediatric patients 12 years of age and older. The FDA does not currently plan to hold an advisory committee meeting to discuss the application.

“We are pleased with the FDA’s acceptance of our NDA for sebetralstat as it brings us one step closer to bringing a potentially transformative therapy to the HAE community,” said Ben Palleiko, Chief Executive Officer of KalVista. “We understand that people living with HAE and their families carry a tremendous burden every day, not knowing when the next attack might occur or whether it might have life-threatening consequences. The compelling data in our NDA package demonstrate that sebetralstat has the potential to significantly change the way people treat and manage their disease. As the first on-demand oral treatment for HAE, we continue to receive strong support and a sense of urgency from healthcare providers, advocates, patients and their families for sebetralstat. I am proud of the team at KalVista for their dedication to achieving this milestone and deeply grateful for the support of patients living with HAE, their families, the HAE scientific community, and HAEA and HAEi patient advocacy organizations.”

The NDA submission was supported by previously announced results, including data from the KONFIDENT Phase 3 clinical trial and the ongoing KONFIDENT-S open label extension study. Sebetralstat met the primary endpoint for its Phase 3 trial with both 300 mg and 600 mg formulations achieving the onset of symptom relief significantly faster than placebo (p