Kalvista Pharm Stock Price, News & Analysis

KalVista Pharmaceuticals (NASDAQ: KALV) has appointed Brian Piekos as its new Chief Financial Officer. Piekos brings over 25 years of financial and strategic planning experience in the biopharmaceutical industry. He joins KalVista from Elicio Therapeutics, where he served as CFO. The appointment comes as KalVista prepares for the commercialization of sebetralstat, a potential novel therapy for hereditary angioedema.

As part of his employment agreement, Piekos received inducement options to purchase 100,000 shares of KalVista's Common Stock at an exercise price of $11.87 per share. These options will vest over a four-year period, subject to his continued service.

KalVista Pharmaceuticals (NASDAQ: KALV) presented additional analyses of sebetralstat, its investigational oral plasma kallikrein inhibitor for hereditary angioedema (HAE) attacks, at the Bradykinin Symposium 2024. The data from phase 2 and 3 trials, including the KONFIDENT-S open-label extension, demonstrated consistent efficacy and safety profiles across the clinical program.

Key findings include:

• Sebetralstat showed rapid symptom relief and a safety profile comparable to placebo
• Median time to treatment was 9 minutes for all attacks and 8 minutes for laryngeal attacks
• Median time to beginning of symptom relief was 1.8 hours for all attacks and 1.3 hours for laryngeal attacks

The oral administration of sebetralstat may address challenges associated with current injectable treatments, potentially transforming HAE management if approved.

KalVista Pharmaceuticals (NASDAQ: KALV) reported significant progress in Q1 2025 fiscal year. The FDA accepted their New Drug Application for sebetralstat, setting a PDUFA date of June 17, 2025. The EMA also validated their Marketing Authorization Application. KalVista plans to file for approval in the UK, Japan, and other countries later in 2024.

Financial highlights include:

• R&D expenses increased to $26.6 million from $19.3 million year-over-year
• G&A expenses rose to $17.6 million from $9.8 million
• Net loss widened to $40.4 million, or $(0.87) per share
• Cash position decreased to $174.3 million from $210.4 million in April 2024

The company initiated a pediatric clinical trial (KONFIDENT-KID) for sebetralstat and published phase 3 KONFIDENT trial data in the New England Journal of Medicine.

KalVista Pharmaceuticals (NASDAQ: KALV) has granted inducement options to nine newly-hired employees. The options allow for the purchase of a total of 55,000 shares of KalVista common stock at an exercise price of $12.37 per share, matching the closing price on September 3, 2024. These options vest over four years, with 25% vesting after one year and the remainder vesting monthly over the following three years. The grants, made under KalVista's Inducement Equity Incentive Plan, are subject to continued employment and have a 10-year term. This action aligns with Nasdaq Listing Rule 5635(c)(4), which allows for inducement grants to new employees.

KalVista Pharmaceuticals (NASDAQ: KALV) announced FDA acceptance of its New Drug Application (NDA) for sebetralstat, an oral plasma kallikrein inhibitor for on-demand treatment of hereditary angioedema (HAE) attacks. The FDA set a PDUFA goal date of June 17, 2025. If approved, sebetralstat would be the first oral, on-demand treatment for HAE in patients aged 12 and older.

The NDA is supported by data from the KONFIDENT phase 3 trial and ongoing KONFIDENT-S open label extension trial. Sebetralstat met the primary endpoint, achieving faster symptom relief than placebo and demonstrating a favorable safety profile. The KONFIDENT-KID trial for pediatric patients aged 2-11 years has begun dosing. KalVista has also submitted a Marketing Authorization Application to the European Medicines Agency and plans to file for approval in other countries in 2024.

KalVista Pharmaceuticals (NASDAQ: KALV) announced the acceptance of six abstracts for presentation at the 2024 Bradykinin Symposium in Berlin, Germany. The event, scheduled for September 5-6, 2024, will feature four oral presentations and two poster presentations on Friday, September 6.

The presentations cover various aspects of sebetralstat, KalVista's drug for Hereditary Angioedema (HAE) treatment. Topics include delayed on-demand treatment, pooled safety and efficacy data, a specific assay for measuring plasma kallikrein activity, and interim analysis of the KONFIDENT-S study. The European subgroup results from the Phase 3 KONFIDENT trial will also be presented.

All presentations will be available on KalVista's website under 'Publications'.

KalVista Pharmaceuticals (NASDAQ: KALV) announced that the European Medicines Agency (EMA) has validated the submission of a Marketing Authorization Application (MAA) for sebetralstat, an oral plasma kallikrein inhibitor for on-demand treatment of hereditary angioedema (HAE). If approved, sebetralstat would be the first oral, on-demand treatment for HAE in Europe. The MAA is supported by results from the KONFIDENT phase 3 clinical trial and ongoing KONFIDENT-S open label extension trial.

Key findings include:

• Sebetralstat met the primary endpoint in phase 3 trials
• Both 300 mg and 600 mg formulations achieved faster symptom relief than placebo
• Median time to beginning of symptom relief for laryngeal attacks was 1.3 hours
• KalVista submitted a New Drug Application (NDA) to the U.S. FDA in June 2024
• KONFIDENT-KID clinical trial initiated to evaluate sebetralstat in pediatric patients aged 2-11 years

KalVista Pharmaceuticals (NASDAQ: KALV) has granted inducement options to eleven newly-hired employees to purchase a total of 90,000 shares of KalVista common stock. The options, issued on August 1, 2024, have an exercise price of $13.83 per share, matching the closing price on the grant date. The vesting schedule includes 25% after one year, with the remainder vesting in equal monthly installments over three years, subject to continued employment. Each option has a 10-year term and falls under KalVista's Inducement Equity Incentive Plan, complying with Nasdaq Listing Rule 5635(c)(4).

KalVista Pharmaceuticals has submitted a New Drug Application (NDA) for sebetralstat, an oral treatment for hereditary angioedema (HAE) attacks, potentially launching in the first half of 2025. The phase 3 KONFIDENT trial data, published in The New England Journal of Medicine, supports the drug's efficacy. The company began a pediatric trial and plans additional regulatory submissions across Europe and Japan this year. Financially, KalVista reported no revenue for the fiscal year ending April 30, 2024. R&D expenses rose to $86.2 million, while G&A expenses increased to $54.3 million. The net loss widened to $126.6 million, or $(3.44) per share. Cash reserves grew to $210.4 million, primarily due to a stock offering in February 2024.