Analyst Summary: Clinical-stage pharmaceutical company KalVista Pharmaceuticals (NASDAQ: KALV) has issued an operational update, along with its Q3 financial results. CEO Andrew Crockett noted that sebetralstat is still being publicized, including in influential medical journals such as The Lancet, with presentations at medical and patient meetings. The data showed the impact of HAE attacks on anxiety and quality of life in people living with HAE, which sebetralstat significantly decreased, while research and development remain a priority. In addition, the Company received FDA regulatory guidance that efficacy tests are not required to support a supplemental FDA filing for the orally disintegrating tablet (ODT) formulation of sebetralstat.
Moreover, the Company has made progress in securing financing, announcing new funding, via a registered direct offering of USD 58 million. The company is now expected to fund operations till 2025. However, the Company has reported no revenue for the three months ending 31 January 2023, and its net loss has increased to USD 21.9 million from USD 20.7 million reported in the same period last year. Risk factors include, but are not limited to, the outcomes of communications with the FDA, the success of its clinical trials and ability to obtain regulatory approvals for sebetralstat and other candidates in development, and its oral Factor XIIa program.