KalVista Pharmaceuticals (KALV) Cantor Global Healthcare Conference 2025 summary

Company overview and recent milestones

• Transitioned to commercial stage with FDA approval of EKTERLY for acute hereditary angioedema (HAE) attacks in July, followed by immediate U.S. launch and U.K. approval.

• EU CHMP recommended approval, with formal EU approval expected in October; additional approvals pursued in four more countries.

• Closed first fiscal quarter as a commercial company on July 31.

Clinical data and product differentiation

• EKTERLY supported by the largest HAE clinical trial program, including robust phase II, phase III, and open-label extension studies.

• Demonstrated efficacy across all attack severities and locations, including laryngeal attacks, and a pristine safety profile.

• Open-label data show patients treat attacks within 10 minutes, with rapid symptom relief and end of progression in under 20 minutes.

• Oral tablet offers injectable-like efficacy with a simple, patient-friendly label and flexible dosing.

Real-world impact and patient behavior

• Existing injectable therapies are effective but have significant barriers, leading to delayed or missed treatments.

• EKTERLY's ease of use encourages earlier treatment, especially among adolescents, who historically delayed therapy due to limited options.

• Open-label study participants consistently treat attacks earlier, and real-world use is expected to mirror these results.

• Concerns about unnecessary treatment are minimal, as patients are well-versed in recognizing true attacks.