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.

XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT

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Form 8-K - Current report - Item 2.02 Item 9.01

KalVista Pharmaceuticals Inc

$KALV reports Q3 results & sebetralstat update; secures funding

Performance Analysis:

KalVista Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing small molecule protease inhibitors. The company has applied its expertise to develop a portfolio of novel small molecule plasma kallikrein inhibitors and is developing a range of oral drug candidates targeting HAE, for which there are currently limited oral options available. The company's lead drug candidate, sebetralstat, has already demonstrated statistically and clinically significant responses across all primary and secondary endpoints during a Phase 2 clinical trial. The drug has received Fast Track and Orphan Drug designations in the U.S. and the EU.

As of early 2022, the company has initiated the Phase 3 KONFIDENT clinical trial to further evaluate the drug's impact on HAE, which is expected to support a New Drug Application (“NDA”) filing. KalVista Pharmaceuticals anticipates receiving the data from KONFIDENT in the second half of 2023, with an NDA filing planned for the first half of 2024. In addition, the company's discovery research team has discovered a range of low nanomolar potency Factor XIIa inhibitors that are selective and orally bioavailable, which the company is looking to move into clinical development in 2023.

Forward-Looking Analysis:

KalVista Pharmaceuticals is aiming to develop a complete range of oral drugs to offer patients suffering from HAE. There is significant potential for KalVista Pharmaceuticals, given the limited oral treatments on the market, and the company's strong scientific foundations position it well to lead the market in the next generation of HAE therapies. The success of sebetralstat would be a significant milestone for the company, and the results from the KONFIDENT study will be a critical catalyst for the shares. 

The company's strategies and focus on expansion into other high unmet need indications in the future are promising, and the anticipated IND filing for Factor XIIa inhibitors suggests that the company's progress in this field is quite positive. However, the company's future financial performance is likely to be impacted by a number of risks and uncertainties, such as macroeconomic conditions, regulatory approvals, and the success of clinical trials. Additionally, competition in the pharmaceutical industry is intense, and companies with deeper pockets could outmatch KalVista Pharmaceuticals in targeting new opportunities. Nonetheless, the company's strong scientific foundations, pipeline of products, and focus on developing proprietary technologies support a favorable outlook for KalVista Pharmaceuticals.

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Form 10-Q - Quarterly report [Sections 13 or 15(d)]

KalVista Pharmaceuticals: Developing New Oral Treatments for HAE.

Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend]

$KALV reports Q3 results & sebetralstat update; secures funding

$KALV reports Q3 results & sebetralstat update; secures funding

KalVista Pharmaceuticals: Developing New Oral Treatments for HAE.

KalVista Pharmaceuticals: Developing New Oral Treatments for HAE.

Announcement: KALV SC 13G/A Statement of acquisition of beneficial ownership by individuals - amendment

Announcement: KALV SC 13G/A Statement of acquisition of beneficial ownership by individuals - amendment

Announcement: KALV SC 13G/A Statement of acquisition of beneficial ownership by individuals - amendment

Announcement: KALV SC 13G/A Statement of acquisition of beneficial ownership by individuals - amendment

Announcement: KALV SC 13G/A Statement of acquisition of beneficial ownership by individuals - amendment

Announcement: KALV SC 13G/A Statement of acquisition of beneficial ownership by individuals - amendment

Announcement: KALV SC 13G/A Statement of acquisition of beneficial ownership by individuals - amendment

Announcement: KALV SC 13G/A Statement of acquisition of beneficial ownership by individuals - amendment