KalVista Q1 Earnings On Deck - Will Sebetralstat's EU Nod Be The Catalyst It Needs?

(RTTNews) - KalVista Pharmaceuticals Inc. (KALV) is due to release its Q1 results on September 4, 2025, before the market opens. Wall Street expects the Cambridge, Massachusetts-based company to post a loss of $0.96 per share on revenue of $2.09 million, marking a potential shift from the zero-revenue quarters that have defined its recent history.

For the first fiscal quarter ended July 31, 2024, the company had net loss of $40.4 million or $0.87 per share. No revenue was recognized for the three months ended July 31, 2024, or July 31, 2023, respectively.

Product Momentum

KalVista's lead asset, EKTERLY, has gained significant regulatory momentum in recent months. In July, EKTERLY received marketing authorization in the UK, becoming the first and only oral on-demand treatment for HAE attacks.

On August 11, KalVista announced that the EMA's Committee for Orphan Medicinal Products reaffirmed orphan designation for sebetralstat, highlighting its role in addressing unmet needs in hereditary angioedema (HAE). The oral plasma kallikrein inhibitor has received a positive CHMP opinion in July, with a final decision from the European Commission expected by early October. If approved, sebetralstat will gain 10 years of market exclusivity in the EU.

Beyond EKTERLY, KalVista is advancing a suite of oral formulations under the KONFIDENT banner, including pediatric (KONFIDENT-KID) and adolescent/adult (KONFIDENT-S) programs, as well as a preclinical Factor XIIa inhibitor targeting HAE.

FY Numbers

The company incurred a net loss of $183.4 million or $3.69 per share for the fiscal year ended April 30, 2025, wider than the prior year's loss of $126.6 million or $3.44 per share. Operating loss was $187.9 million versus a loss of $140.4 million incurred a year ago.

Research and development expenses declined to $71.7 million from $86.2 million last year, largely reflecting reduced clinical trial expenses, preclinical activities, and recognizing expense associated with EKTERLY (sebetralstat) pre-commercial awareness within General & Administrative.

"The FDA approval of EKTERLY represents a major milestone—not only as the first commercial product for KalVista, but more importantly, as the first and only oral on-demand therapy for people living with HAE," said Ben Palleiko, CEO of KalVista Pharmaceuticals.

"EKTERLY delivers a long-awaited treatment that is safe, effective, and easy to administer. Our commercial team is actively engaging in the field, leveraging their expertise to educate and activate patients and physicians to enable timely access, drive awareness, and support informed treatment decisions around this important new therapy," added Ben Palleiko.

With commercial partners now established in Canada and Japan, and six global regulatory submissions under review, the company believes that EKTERLY is poised to become the foundational therapy for HAE management worldwide.

Cash, cash equivalents, and marketable securities were $220.6 million on April 30, 2025, compared to $210.4 million on April 30, 2024.

Stock Movement

The stock, KALV, which has been trading between $7.30 and $16.32 for the past 52-week period, closed Wednesday's trade at $14.16, down 13 cents or 0.91%, with trading volume of over 1.409 million shares versus an average volume of 1.229 million shares. In the after-hours session, the stock declined further to $13.80, down 36 cents or 2.54%.