KalVista Pharmaceuticals (KALV) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Product and clinical development

• Sebetralstat, an oral therapy for hereditary angioedema (HAE), has completed Phase III trials and NDA/MA filings in the US and Europe for on-demand treatment of HAE attacks.

• The CONFIDENT Phase III study was the largest and most inclusive HAE trial, enrolling all attack types and severities, including laryngeal attacks, and allowing patients on prophylaxis.

• Sebetralstat demonstrated rapid onset, with symptom relief in 1.6 hours for the 300mg dose, and a safety profile comparable to placebo.

• Open label data show patients treat attacks much earlier (within 9 minutes on average) and at higher rates (over 85% of attacks) compared to standard care.

• The re-dose rate in open label studies is around 25%, aligning with real-world data for existing therapies.

Market landscape and competitive positioning

• The on-demand HAE market remains stable at over 120,000 prescriptions annually, with a market size north of $1 billion, despite the rise of prophylactic therapies.

• Two stable patient segments drive demand: those satisfied with on-demand therapy and those on prophylaxis with frequent breakthrough attacks.

• Sebetralstat is positioned to become a foundational therapy, potentially shifting treatment discussions away from default prophylaxis.

• Competitor programs use less inclusive trial designs, focusing on subsets of attacks, while sebetralstat's data support efficacy across all attack types.

• Payers are increasingly aware of high prophylaxis costs and may welcome alternatives that reduce overall spend.

Commercial strategy and outlook

• Plans are in place for direct launches in the US, Europe, and Japan, with experienced teams and distributor partnerships for other regions.

• The commercial infrastructure is lean, with a small sales force and limited late-stage R&D spend, supporting a path to cash flow positivity.

• Significant global interest has been received from potential partners in various geographies.

• Within a few years post-launch, the product is expected to be available in 10 or more countries.

• Key goals for the next 12 months include US launch, near-term European launch, and advancing additional global launches.