KalVista Pharmaceuticals (KALV) Jefferies London Healthcare Conference 2024 summary

Product development and clinical data

• Sebetralstat is under FDA review for on-demand treatment of hereditary angioedema (HAE), with a PDUFA date set for June 17, 2025, and global filings underway.

• The clinical program is the largest in HAE, treating over 2,000 attacks, including all severities, locations, and both adults and adolescents.

• Phase III trials showed initial symptom relief at 1.6 hours post-dose, with efficacy on par or better than injectables and a pristine safety profile.

• Open label extension data confirm broad efficacy and safety across diverse patient populations, including laryngeal attacks.

• Post-hoc analyses highlight real-world treatment delays and the need for early intervention, supporting guideline-based early treatment.

Market dynamics and unmet need

• On-demand HAE market is stable, with current therapies being injectable or infused and limited competition.

• Prophylaxis market is crowded and competitive, but adherence challenges and breakthrough attacks sustain demand for on-demand options.

• Many patients delay treatment due to the burden of injectables, and a significant portion of attacks remain untreated.

• Adolescents and patients with frequent breakthrough attacks represent high unmet need segments.

• Oral on-demand therapy is expected to disrupt the paradigm, increasing the proportion of treated attacks and attracting some prophylaxis users.

Competitive landscape and differentiation

• Competitor Pharvaris uses older trial designs and endpoints, making direct comparison difficult; no clear differentiation in efficacy.

• Sebetralstat’s trial allowed early treatment of all attack severities, aligning with guidelines and real-world practice.

• Label expected to be broad, covering adolescents and all attack types, including laryngeal, unlike some competitors.

• Data-driven approach and robust safety/efficacy profile position sebetralstat as a preferred oral option.