Kalvista Pharm Stock Price, News & Analysis

KalVista Pharmaceuticals (NASDAQ: KALV) announced that its compensation committee has granted stock options to twelve newly-hired employees. The inducement grants total 78,000 shares of common stock with an exercise price of $10.61 per share, matching the closing price on November 1, 2024. The options vest over four years, with 25% vesting after one year and the remainder vesting monthly over three years, contingent on continued employment. These 10-year term options were granted under KalVista's Inducement Equity Incentive Plan in accordance with Nasdaq Listing Rule 5635(c)(4).

KalVista Pharmaceuticals (KALV) has announced the pricing of an underwritten offering of 5.5 million shares at $10.00 per share, expecting to raise $55 million. Concurrently, the company entered a private placement agreement with DRI Healthcare Acquisitions LP for an additional 500,000 shares at the same price, raising an additional $5 million. The proceeds will fund the clinical development of sebetralstat and its planned commercialization. The offerings are expected to close on November 5, 2024, with Jefferies, BofA Securities, TD Cowen, and Stifel acting as joint book-running managers.

KalVista Pharmaceuticals (NASDAQ: KALV) has secured a synthetic royalty financing agreement with DRI Healthcare Trust worth up to $184 million to support the commercial launch of sebetralstat, potentially the first oral on-demand therapy for hereditary angioedema (HAE). The deal includes a $100 million upfront payment, an optional $22 million payment upon U.S. approval, and up to $57 million in sales-based milestones. The FDA has set a PDUFA target date of June 17, 2025. Under the agreement, KalVista will pay DRI tiered royalties ranging from 0.25% to 5.00% based on annual global net sales thresholds. DRI has also expressed interest in a potential $5 million equity investment in KalVista.

KalVista Pharmaceuticals (NASDAQ: KALV) presented new data for sebetralstat at the 2024 American College of Allergy Asthma and Immunology. Phase 3 trial results showed that early treatment leads to faster attack resolution in hereditary angioedema (HAE) patients. The data demonstrated that sebetralstat 300mg and 600mg achieved faster reduction in symptom burden compared to placebo, with median times of 5.0 and 5.2 hours versus >12 hours. A network meta-analysis found no significant differences between sebetralstat 300mg and IV recombinant C1-inhibitor in time to symptom relief. For laryngeal attacks, sebetralstat 600mg showed median time to symptom relief of 1.5 hours.

KalVista Pharmaceuticals (NASDAQ: KALV) announced the acceptance of five abstracts for e-Poster presentation at the 2024 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Boston, MA from October 24-28. The presentations focus on various aspects of hereditary angioedema (HAE) treatment, including:

• Patient-reported anxiety impacts on injectable on-demand treatment utilization
• Sebetralstat's effectiveness in treating laryngeal HAE attacks
• Reduction of HAE attack symptom burden in the KONFIDENT Phase 3 trial
• Indirect treatment comparison between oral sebetralstat and intravenous rhC1-INH
• Correlation of treatment timing with attack duration in the KONFIDENT Phase 3 trial

The e-Poster presentations are scheduled for October 25 at various times in Exhibit Hall A. Links to all posters and presentations will be available on the KalVista website under "Publications".

KalVista Pharmaceuticals presented data at the 2024 HAEi Global Angioedema Forum showing the effectiveness of sebetralstat in reducing anxiety during hereditary angioedema (HAE) attacks. The data, from the KONFIDENT phase 3 clinical trial, revealed that sebetralstat significantly reduced anxiety compared to placebo, especially in patients with moderate-to-extreme anxiety.

Key findings include:

• Anxiety reduction correlated with earlier symptom relief
• Sebetralstat 300mg and 600mg doses showed significant anxiety reduction versus placebo
• For moderate-to-extreme anxiety, sebetralstat showed greater improvement at 4 and 12 hours compared to placebo

Additional presentations highlighted the impact of HAE attacks on quality of life, work productivity, and the potential benefits of early treatment with oral on-demand therapies.

KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) has announced the granting of inducement options to six newly-hired employees. These options, totaling 31,000 shares of KalVista common stock, were granted on October 1, 2024, in compliance with Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $11.39 per share, matching the closing price of KalVista common stock on the grant date.

The vesting schedule for these options includes 25% vesting on the one-year anniversary of the vesting commencement date, with the remaining 75% vesting in equal monthly installments over the following three years. Each option has a 10-year term and is subject to KalVista's Inducement Equity Incentive Plan and a stock option agreement.

KalVista Pharmaceuticals (NASDAQ: KALV) has submitted Marketing Authorization Applications (MAAs) for sebetralstat in the United Kingdom, Switzerland, Australia, and Singapore. Sebetralstat is an investigational oral plasma kallikrein inhibitor for on-demand treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 and older. The submissions were made through the Access Consortium framework, designed to maximize regulatory collaboration and support timely review.

The MAAs are supported by results from the KONFIDENT phase 3 clinical trial and ongoing KONFIDENT-S open label extension trial. Sebetralstat met its primary endpoint, achieving faster symptom relief than placebo, and demonstrated a consistent safety profile. The KONFIDENT-KID trial for pediatric patients aged 2-11 began dosing ahead of schedule in June 2024.

If approved, sebetralstat would be the first oral on-demand treatment for HAE, addressing a significant unmet need globally.

KalVista Pharmaceuticals (NASDAQ: KALV) announced the acceptance of nine abstracts for poster presentation at the HAEi Global Angioedema Forum (GAF) in Copenhagen, Denmark on October 4-5, 2024. The presentations cover various aspects of Hereditary Angioedema (HAE) and its treatment, including:

1. Impact of oral sebetralstat on anxiety associated with HAE attacks
2. Anxiety associated with parenteral on-demand HAE treatment
3. Conceptual model of patient anxiety and treatment burden during HAE attacks
4. Effects of delayed HAE attack treatment on quality of life and work ability
5. Impact of HAE attacks on patients receiving long-term prophylaxis or on-demand treatment
6. Analysis of European and US patient subgroups in the Phase 3 KONFIDENT trial
7. Patient-reported benefits of early on-demand HAE attack treatment
8. Patient perspectives on future oral on-demand therapies for HAE attacks
9. Global frequency and diagnosis of HAE with normal C1INH