Sebetralstat

Positioned to Expand Patient Access and Accelerate Impact in Rare Diseases PARMA, Italy & FRAMINGHAM, Mass.--(BUSINESS WIRE)--Chiesi Group (“Chiesi”), an international research-focused biopharmaceutical group and certified B Corp, today announced the completion of its acquisition of KalVista Pharmaceuticals, Inc. (“KalVista”). KalVista is now part of Chiesi Group and will contribute to the growth of the Rare Diseases business unit, focused on research, development and commercialization of therapies for rare and ultra-rare conditions. With the completion of the transaction, Chiesi assumed ownership of EKTERLY ® (sebetralstat), the first and only oral, on-demand treatment for hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older. EKTERLY is already approved in the United States, United Kingdom, European Union, Japan and other regions, with ongoing studies exploring its use for treating HAE attacks in children aged 2 to 11, and multiple regulatory applications under review in key global markets. Completion of the Tender Offer and Transaction Details On June 11, 2026, Chiesi successfully completed its tender offer for all outstanding shares of KalVista common stock for $27.00 per share in cash and accepted for payment all shares validly tendered and not validly withdrawn as of the expiration time of the tender offer, which shares represented approximately 77.8% of KalVista’s outstanding shares. Following completion of the offer, Chiesi completed its acquisition of KalVista through a merger of a wholly owned subsidiary of Chiesi with and into KalVista, in connection with which the outstanding shares of KalVista common stock were cancelled and converted into the right to receive the same $27.00 per share in cash. As a result of the merger, KalVista became a wholly owned subsidiary of Chiesi and KalVista’s common stock ceased trading on the Nasdaq Global Market. Additional details regarding the tender can be found in a form 8-K filed by KalVista today with the Securities and Exchange Commission. Advisors Lazard served as exclusive financial advisor to Chiesi and Ropes & Gray LLP served as legal advisor. Centerview Partners LLC acted as financial advisor to KalVista and Kirkland & Ellis LLP and Fenwick & West LLP served as legal advisors. ****** About EKTERLY ® (sebetralstat) EKTERLY (sebetralstat) is a novel plasma kallikrein inhibitor approved in the United States, European Union, United Kingdom, Switzerland, Australia, Singapore and Japan for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older. For more information, including the full US Prescribing Information , visit EKTERLY.com . About Hereditary Angioedema Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. Treatment guidelines recommend treating attacks as early as possible to prevent progression of swelling and shorten the time to attack resolution, and to consider treatment for all attacks, regardless of anatomic location or severity. About Chiesi Group Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By changing its legal status to a Benefit Corporation in Italy, the US, France and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet verified standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,900 employees. The Group’s research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. For more information, visit or the website of your local Chiesi affiliate. About Chiesi Global Rare Diseases Chiesi Global Rare Diseases is a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases. As a family business, Chiesi Group strives to create a world where it is common to have therapy for all diseases and acts as a force for good, for society and the planet. The goal of the Global Rare Diseases unit is to ensure equal access so as many people as possible can experience their most fulfilling life. The unit collaborates with the rare disease community around the globe to bring voice to underserved people in the health care system. For more information, visit . About KalVista Pharmaceuticals, Inc. KalVista is a global pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. The KalVista team discovered and developed sebetralstat—the first and only oral on-demand treatment for hereditary angioedema (HAE)—and continues to work closely with the global HAE community to improve treatment and care for this disease around the world. For more information about KalVista, please visit and follow us on LinkedIn , X , Facebook and Instagram . INDICATION AND IMPORTANT SAFETY INFORMATION INDICATION EKTERLY ® (sebetralstat) is a plasma kallikrein inhibitor indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. IMPORTANT SAFETY INFORMATION Adverse reactions: The most commonly reported adverse reaction was headache. Drug interactions: EKTERLY is a substrate of CYP3A4. Concomitant use of EKTERLY with a strong CYP3A4 inhibitor increases sebetralstat exposure, which may increase the risk of sebetralstat adverse reactions. Avoid use of EKTERLY with strong CYP3A4 inhibitors and reduce the dose of EKTERLY to one dose of 300 mg (one tablet) with moderate CYP3A4 inhibitors. Concomitant use of EKTERLY with a strong or moderate CYP3A4 inducer decreases sebetralstat exposure, which may decrease efficacy. The use of EKTERLY with strong or moderate CYP3A4 inducers is not recommended. Use in specific populations: Avoid use of EKTERLY in patients with severe hepatic impairment (Child-Pugh Class C). The recommended dosage of EKTERLY is one dose of 300 mg (one tablet) in patients with moderate hepatic impairment (Child-Pugh Class B). There are no available data on EKTERLY in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are no data on the presence of sebetralstat or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. The safety and effectiveness of EKTERLY in pediatric patients aged under 12 years of age have not been established. To report SUSPECTED ADVERSE REACTIONS, contact KalVista Pharmaceuticals, Inc. at 1-855-258-4782 or FDA at 1-800-FDA-1088 or . Please see full Prescribing Information . FORWARD-LOOKING STATEMENT This communication contains forward-looking statements related to Chiesi and KalVista. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “target,” “seek,” “believe,” “project,” “estimate,” “expect,” “position,” “strategy,” “future,” “likely,” “may,” “should,” “will” or the negative of these terms or similar references to future periods, although not all forward-looking statements contain these words. In this communication, forward-looking statements include statements about the post-closing operations and the outlook for the parties’ businesses, including, without limitation, the ability to commercialize current and future product candidates (including further commercialization of EKTERLY). Forward-looking statements are subject to certain risks, uncertainties or other factors that are difficult to predict, and could cause actual events or results to differ materially from those currently indicated in any such statements due to a number of risks and uncertainties. Those risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include, among other things: the effects of the transaction on relationships with employees, other business partners or governmental entities; the difficulty of predicting the timing or outcome of U.S. Food and Drug Administration approvals or actions, if any; the impact of competitive products and pricing; the risk that the businesses will not be integrated successfully and that Chiesi may not realize the potential benefits of the transactions; other business effects, including the effects of industry, economic or political conditions outside of the companies’ control; actual or contingent liabilities; the success of the parties’ efforts to commercialize EKTERLY, including revenues from sales of EKTERLY; the ability to successfully obtain additional foreign regulatory approvals for sebetralstat; expectations about the safety and efficacy of sebetralstat; and expectations regarding market adoption and utilization trends. You should not place undue reliance on these statements. All forward-looking statements are based on information currently available to Chiesi and KalVista, and Chiesi and KalVista disclaim any obligation to update the information contained in this communication as new information becomes available. PP-RA-02172 V1.0 Contacts Press Info: Chiesi Group: Anna Bonisoli Alquati, Head of Global External Communications: mediarelations@chiesi.com Chiara Travagin, Head of Global Communications, Rare: mobile +39 348.8818985, e-mail: c.travagin@chiesi.com Michela Lijoi, Global External Communications Sr. Manager: mobile +39 328.6353044, e-mail: m.lijoi@chiesi.com

Presentations at ISPOR and the Eastern Allergy Conference highlight substantial treatment burden, caregiver anxiety, delayed or untreated HAE attacks, and high healthcare resource utilization among children aged 2–11 living with HAE FRAMINGHAM, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals , Inc. (Nasdaq: KALV) today announced new data highlighting the burden of injectable on-demand treatment in children aged 2–11 with hereditary angioedema (HAE) presented at ISPOR 2026 and the Eastern Allergy Conference (EAC). “These data highlight the significant unmet needs that exist for children living with HAE and the families who care for them,” said Ben Palleiko, Chief Executive Officer of KalVista. “Currently, the only FDA-approved on-demand treatment for children ages 2–11 requires intravenous administration, which can place a considerable burden on both children and caregivers during already stressful attacks. Across real-world treatment patterns, healthcare resource utilization, and caregiver experiences, these findings reinforce the need for new treatment options that are easy to use and support early, consistent treatment of attacks. As the first and only oral on-demand treatment for HAE, EKTERLY ® has the potential to meaningfully improve the treatment experience for this pediatric population and serve as a family-wide solution across generations.” On-Demand Treatments for Hereditary Angioedema and Healthcare Resource Utilization in Pediatric (2–11 Years) Patients: A US Claims Database Analysis was presented at ISPOR by Alice Wang, Senior Director, Global Health Economics and Value Demonstration, KalVista Pharmaceuticals. Real-world claims data showed that while about two thirds of children aged 2–11 were prescribed IV pdC1INH—the only FDA-approved on-demand HAE treatment for this population—the majority of treatments utilized were off-label (primarily icatibant), suggesting families and providers may be seeking less invasive treatment options. Although the mean on-demand dosing rate was 0.43 per patient per month, the rate for pdC1INH was far less (0.28) than that of icatibant (0.72). Healthcare resource utilization was substantial with 47% of patients requiring emergency room care and 17% utilizing home-health services. Burden of Injectable On-Demand Treatment for Hereditary Angioedema Attacks in Children will be presented at EAC by Timothy Craig, DO, Professor, Departments of Medicine and Pediatrics, Division of Pulmonary, Allergy and Critical Care Medicine, Penn State Health. A caregiver survey found that nearly half of children did not receive on-demand treatment for their most recent HAE attack. Among children who did treat their last attack, 93.7% experienced anxiety about using injectable on-demand treatment, with 68.8% reporting extreme anxiety. Among the most common reasons for not treating or feeling anxious about treatment were fear of needles and anticipated burning, stinging or pain from the injection. Seventy-five percent experienced a side effect from treatment, most commonly pain from the needle and burning, stinging or pain while injecting treatment. Caregiver Burden Associated with Injectable On-Demand Treatment of Hereditary Angioedema Attacks in Children will be presented at EAC by H. Henry Li, MD, Institute for Asthma and Allergy. The same caregiver survey found that during their child’s last HAE attack, 43% occurred outside the home and 37% occurred while they were not with their child. 63% of caregivers had difficulty administering treatment and 31% took their child to a hospital or emergency center for treatment. Caregiver anxiety was high, with 90% of caregivers reporting anxiety about deciding to treat, including 60% who felt extremely anxious. Mean time to treatment was 2.8 hours, with only 31% of caregivers treating in less than one hour. The majority of caregivers reported that the most important factor that could make on-demand treatment better for their child would be an oral therapy. “Across real-world datasets, we consistently see a substantial treatment burden for young children with HAE and their caregivers, often resulting in treatment avoidance or long delays in on-demand treatment. We also observe high rates of anxiety among children and caregivers related to injectable treatments. We believe these challenges drive higher-than-expected healthcare resource utilization, including emergency room visits and home healthcare support for treatment administration,” said Paul Audhya, MD, MBA, Chief Medical Officer of KalVista. “It is therefore not surprising that caregivers identify oral therapy as the most important factor that could improve on-demand treatment for their child. Ultimately, these presentations reinforce the value of an oral on-demand therapy that can be taken anytime, anywhere, without the challenges associated with injectables, and may help enable guideline-aligned care for the first time.” KalVista continues to execute the KONFIDENT-KID trial—the fastest-enrolling pediatric HAE trial conducted to date—and intends to submit a new drug application for sebetralstat in children aged 2–11 in the third quarter of 2026. A link to the presentation is available on the KalVista website under Publications . About Hereditary Angioedema Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. Treatment guidelines recommend treating attacks as early as possible to prevent progression of swelling and shorten the time to attack resolution, and to consider treatment for all attacks, regardless of anatomic location or severity. About KONFIDENT-KID KONFIDENT-KID is an open label clinical trial of sebetralstat for on-demand treatment of HAE attacks in pediatric patients. Originally designed to enroll 24 pediatric patients, the trial was met with high demand and will ultimately enroll approximately 36 children aged 2-11 years across seven countries in North America, Europe and Asia. KONFIDENT-KID will collect safety, pharmacokinetic and efficacy data for each patient for up to one year and features a proprietary pediatric oral disintegrating tablet (ODT) formulation of sebetralstat. If approved, sebetralstat would be the first oral on-demand therapy for this age group, and only the second FDA-approved on-demand therapy of any type for this population. About EKTERLY ® (sebetralstat) EKTERLY (sebetralstat) is a novel plasma kallikrein inhibitor approved in the United States, European Union, United Kingdom, Switzerland, Australia, Singapore and Japan for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older. EKTERLY is the first and only oral on-demand treatment for HAE, offering efficacious and safe treatment of attacks without the burden of injections. With a US regulatory filing planned for 2026 to expand use to children aged 2–11, and additional filings anticipated in key global markets, EKTERLY has the potential to become the foundational therapy for HAE management worldwide. For more information, including the full US Prescribing Information , visit EKTERLY.com . About KalVista Pharmaceuticals, Inc. KalVista is a global pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. The KalVista team discovered and developed EKTERLY ® —the first and only oral on-demand treatment for hereditary angioedema (HAE)—and continues to work closely with the global HAE community to improve treatment and care for this disease around the world. For more information about KalVista, please visit and follow us on LinkedIn , X , Facebook and Instagram . Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "position," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, information relating to our business and business plans, the success of our efforts to commercialize EKTERLY ® (sebetralstat), our ability to successfully obtain foreign regulatory approvals for sebetralstat, our expectations about the safety and efficacy of sebetralstat, the timing of clinical trials and their results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-KID trial, and the ability of EKTERLY to treat HAE. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our transition report on Form 10-KT for the transition period from May 1, 2025 to December 31, 2025, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Contacts Ryan Baker Head, Investor Relations (617) 771-5001 ryan.baker@kalvista.com Molly Cameron Senior Director, Corporate Affairs (978) 339-3378 molly.cameron@kalvista.com