KalVista Pharmaceuticals

KalVista Pharmaceuticals appoints Jebediah T. Ledell as COO to support its evolution into a commercial entity, preparing for the global launch of sebetralstat, an investigational drug for hereditary angioedema. The company focuses on developing oral medicines for rare diseases.

KalVista Pharmaceuticals reports a $(45.8) million operating loss, driven by increased expenses, and a $(42.3) million net loss. The company advances sebetralstat, an oral therapy for hereditary angioedema (HAE), with successful Phase 3 trials and regulatory submissions to the FDA, EMA, and other authorities. KalVista plans to move to a new headquarters in 2025 and anticipates continued investment in sebetralstat's commercialization, despite expected losses.

KalVista Pharmaceuticals reported Q2 fiscal 2024 results, highlighting FDA acceptance of sebetralstat's NDA with a PDUFA date of June 17, 2025, and multiple international MAA submissions. Financials include pro forma cash and equivalents of $292.2 million, no revenue, R&D expenses of $16.6 million, and G&A expenses of $29.2 million, primarily due to pre-commercial activities.

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KalVista Pharmaceuticals secures up to $184 million synthetic royalty financing from DRI Healthcare Trust to fund the commercial launch of sebetralstat, an oral on-demand therapy for hereditary angioedema (HAE), with a potential U.S. approval in June 2025.

DRI Healthcare Trust acquires royalty interest in sebetralstat from KalVista for up to $179M, including $100M upfront, $57M in sales-based milestones, and a $22M optional payment. Additionally, the Trust invests $5M in KalVista's common stock. Sebetralstat, an oral on-demand therapy for HAE, shows significant efficacy and safety in trials. FDA and EMA are reviewing the NDA and MAA, respectively, with potential approval by June 2025. The deal includes tiered royalties on net sales and a potential $50M milestone payment.

KalVista Pharmaceuticals presented data at ACAAI showing sebetralstat's potential for HAE on-demand treatment, with faster attack resolution when treated early. Sebetralstat reduced symptom burden significantly compared to placebo and showed no significant differences in symptom relief timing compared to IV rhC1-INH. The drug has Fast Track and Orphan Drug Designations from the U.S. FDA and is under regulatory review with a PDUFA goal date of June 17, 2025. KalVista continues to develop sebetralstat and other treatments for rare diseases.