Latest news with #KalVistaPharmaceuticals
Business Wire
5 days ago
- Health
- Business Wire
KalVista Pharmaceuticals to Present New Sebetralstat Data at the European Academy of Allergy and Clinical Immunology Congress 2025
CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced the acceptance of six scientific abstracts at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025 taking place in Glasgow, United Kingdom from June 13–16, 2025. Details are as follows: Potential for Sebetralstat to Address Pseudo-allergic Reaction Burden Secondary to Icatibant in HAE (D1.324): Sally L. Hampton, Paul K. Audhya, Michael D. Smith, Christopher M. Yea. Results will be shared as a poster presentation from 12:00–1:00 pm BST in the Poster Zone. Saturday, June 14 Psychological Burden Associated with Injectable HAE On-Demand Treatments: A Patient and Caregiver Interview Study (D2.324): Sorena Kiani-Alikhan, Aleena Banerji, Paula Busse, Timothy Craig, Patrick Yong, Rebekah Hall, Siu Hing Lo, Caleb Dixon, Paul Audhya, Alice Wang, Tomaz Garcez. Results will be shared as a late poster presentation from 12:00–1:00 pm BST in the Poster Zone. Sebetralstat for Treatment of HAE Attacks in Patients Receiving Berotralstat, Lanadelumab, or C1 Inhibitor for Long-term Prophylaxis: Interim Analysis from KONFIDENT-S (001408): Marc A. Riedl, Emel Aygören-Pürsün, Jonathan A. Bernstein, Paula J. Busse, Mauro Cancian, Danny M. Cohn, Timothy Craig, Henriette Farkas, Sorena Kiani-Alikhan, Tamar Kinaciyan, H. Henry Li, William R. Lumry, Michael E. Manning, Jason Raasch, Daniel F. Soteres, Raffi Tachdjian, H. James Wedner, James Hao, Michael D. Smith, Paul K. Audhya, Andrea Zanichelli. Results will be shared as an oral presentation from 3:36–3:48 pm BST in the Innovation Hub. Sunday, June 15 Adherence to Long-Term Prophylaxis for Hereditary Angioedema and the Impact on On-demand Treatment Claims in the US (000644): Daniel F. Soteres, Raffi Tachdjian, Maeve O'Connor, Chirag Maheshwari, Alice Wang, Paul K. Audhya, Timothy Craig. Results will be shared as a flash talk presentation from 9:21–9:28 am BST in the Dochart 1 room. Anxiety Associated with Parenteral On-Demand Treatment for Hereditary Angioedema Attacks in Patients from Italy (D3.394): Mauro Cancian, Paola Triggianese, Pietro Accardo, Francesco Arcoleo, Donatella Bignardi, Caterina Colangelo, Francesco Giardino, Antonio Gidaro, Marica Giliberti, Maria Domenica Guarino, Paola Lucia Minciullo, Stefania Nicola, Francesca Perego, Riccardo Senter, Giuseppe Spadaro, Massimo Triggiani, Sherry Danese, Julie Ulloa, Vibha Desai, Paul Audhya, Andrea Zanichelli. Results will be shared as a poster presentation from 12:45–1:45 pm BST in the Poster Zone. Monday, June 16 Impact of Delayed Treatment of Hereditary Angioedema Attacks: Insights from Patient Surveys Across France, the United Kingdom, and the United States (000325): Alexis Bocquet, Paula J. Busse, Timothy Craig, Tariq El-Shanawany, Tomaz Garcez, Padmalal Gurugama, Rashmi Jain, Sorena Kiani-Alikhan, Maeve O'Connor, Cristine Radojicic, Sinisa Savic, H. James Wedner, Patrick Yong, Sherry Danese, Julie Ulloa, Vibha Desai, Paul K. Audhya, Sandra Christiansen. Results will be shared as a flash talk presentation from 11:34–11:41 am BST in the Dochart 2 room. KalVista is also sponsoring a symposium for healthcare professionals on Saturday, June 14, from 5:15–6:15 pm BST in the Alsh Ballroom, titled 'Closing Gaps in HAE Management: Understanding what control means for your HAE patients'. Chaired by Douglas Jones (USA), this panel discussion will feature presentations by Stephen Betschel (Canada), Thomas Buttgereit (Germany) and Sinisa Savić (UK). Links to all presentations can be found on the KalVista website under Publications. About Sebetralstat Sebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older, with ongoing studies exploring its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide. 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. All currently approved on-demand treatment options require either intravenous or subcutaneous administration. About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities. For more information about KalVista, please visit or follow us on social media at @KalVista and LinkedIn. 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," "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, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. 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 annual report on Form 10-K for the year ended April 30, 2024, 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.
Yahoo
7 days ago
- Business
- Yahoo
KalVista Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
CAMBRIDGE, Mass. & SALISBURY, England, June 03, 2025--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV), today announced that the compensation committee of KalVista's board of directors granted five newly-hired employees inducement options to purchase an aggregate of 50,000 shares of KalVista common stock on June 1, 2025 as inducements material to each employee entering into employment with KalVista. The options have an exercise price that is equal to the closing price of KalVista common stock on the grant date. One-fourth of the options vest on the one-year anniversary of the vesting commencement date and the remainder vest in equal monthly installments over the next three years, in each case subject to the new employee's continued service with the company. Each stock option has a 10-year term and is subject to the terms and conditions of KalVista's Inducement Equity Incentive Plan and a stock option agreement covering the grant. The options were granted in accordance with Nasdaq Listing Rule 5635(c)(4). About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities. For more information about KalVista, please visit or follow on social media at @KalVista and LinkedIn. View source version on Contacts KalVista Pharmaceuticals, Inc. Investors: Ryan BakerHead, Investor Relations(617) Media: Molly CameronDirector, Corporate Communications(857)
Yahoo
02-06-2025
- Business
- Yahoo
KalVista Pharmaceuticals Medical Congress Presentations Highlight Potential of Sebetralstat to Redefine Hereditary Angioedema Management
–Attack progression halted in median 19.8 minutes after treatment with sebetralstat in both KONFIDENT and KONFIDENT-S trials– –Sebetralstat data demonstrated rapid relief and resolution of severe HAE attacks– CAMBRIDGE, Mass. & SALISBURY, England, June 02, 2025--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced new sebetralstat findings related to time to end of progression of hereditary angioedema (HAE) attacks, and the effectiveness of treatment of attacks considered the most debilitating by patients, mucosal attacks, and attacks that have progressed in severity after a treatment delay. These data were presented at two congresses taking place concurrently: the 14th C1-inhibitor Deficiency & Angioedema Workshop in Budapest, Hungary, and the Eastern Allergy Conference (EAC) in Palm Beach, Florida, from May 29–June 1, 2025. Time to End of Progression of Hereditary Angioedema Attacks Treated with Sebetralstat was presented by William Lumry, M.D., Clinical Professor of Internal Medicine at the University of Texas Southwestern Medical School in Dallas and Director at Allergy and Asthma Research Associates, Dallas, Texas, United States. Time to end of attack progression (n=1591 attacks) in KONFIDENT-S: median 19.8 minutes Results from the open-label extension (KONFIDENT-S) aligned closely with the pivotal phase 3 trial, KONFIDENT, reinforcing the rapid effect of sebetralstat after absorption "Stopping the progression of an HAE attack as early as possible is paramount to mitigating its impact on patients," said Dr. Lumry. "In both the KONFIDENT and KONFIDENT-S studies, sebetralstat halted attack progression in a median time of 19.8 minutes. As prior data have demonstrated near-complete plasma kallikrein inhibition 15 minutes after treatment, this analysis reveals that attacks are halted minutes after absorption. The consistency of findings across the KONFIDENT and KONFIDENT-S trials underscores the potential of sebetralstat as an effective and rapid-acting on-demand treatment for HAE attacks." Effectiveness of sebetralstat for the on-demand treatment of mucosal hereditary angioedema attacks: interim analysis from KONFIDENT-S was presented by Henriette Farkas, M.D., PhD, DSc, Professor of Allergology and Clinical Immunology at Semmelweis University and Head of the Hungarian Angioedema Center of Reference and Excellence, Budapest, Hungary. Patients were able to self-administer sebetralstat quickly, with a median time to treatment of 20 minutes for abdominal attacks and 11.5 minutes for laryngeal attacks The median time to beginning of symptom relief was 1.3 hours for both abdominal and laryngeal attacks Of attacks reaching symptom relief within 12 hours, 96% did so before or without the need for an additional sebetralstat administration Sebetralstat was well-tolerated, even in laryngeal attacks, with no reported difficulties swallowing the oral tablet "Mucosal HAE attacks, particularly those affecting the larynx, are a significant concern for patients and clinicians due to the risk of rapid progression and severe consequences, including the possibility of asphyxiation if left untreated," said Dr. Farkas. "These interim data from KONFIDENT-S demonstrate that sebetralstat provided rapid relief and resolution of both abdominal and laryngeal attacks with a favorable safety profile. Patients were able to self-administer sebetralstat very early in the course of an attack, when most attacks were still mild or moderate in severity." Effectiveness of Sebetralstat for Severe or Very Severe Hereditary Angioedema Attacks in KONFIDENT-S was presented by H. Henry Li, M.D., Director of Immunology at the Institute for Asthma and Allergy, Wheaton, Maryland, United States. Sebetralstat was used to treat 76 attacks that had progressed to severe or very severe after a median of 2.16 hours from attack onset, demonstrating its utility in more advanced stages of HAE attacks The median time to beginning of symptom relief for these attacks was 1.36 hours, with reduction in attack severity and substantial reduction of symptom burden in a median of 1.77 hours and 9.15 hours, respectively "When attacks are not treated early in accordance with guidelines, they can escalate and become severe," said Dr. Li. "We conducted this analysis of KONFIDENT-S to assess the utility of sebetralstat in more advanced stages of attacks that were associated with delayed treatment. Sebetralstat delivered symptom relief in a median time of 1.36 hours, reinforcing its potential as an on-demand treatment for challenging attack scenarios." "These new data underscore the potential of sebetralstat to fundamentally change HAE attack management," stated Paul Audhya, M.D., MBA, Chief Medical Officer of KalVista. "Even in real-world, high-stakes scenarios—be it mucosal attacks or severe attacks due to delayed treatment—sebetralstat consistently delivered rapid and reliable relief. The uniformity of these results, paired with an oral tablet formulation, solidifies our belief that sebetralstat can empower patients to act swiftly and recover quickly. We remain committed to bringing this innovative therapy to the HAE community as quickly as possible." Links to all presentations can be found on the KalVista website under Publications. About SebetralstatSebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older, with ongoing studies exploring its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide. About Hereditary AngioedemaHereditary 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. All currently approved on-demand treatment options require either intravenous or subcutaneous administration. About KalVista Pharmaceuticals, Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities. For more information about KalVista, please visit or follow us on social media at @KalVista and LinkedIn. Forward-Looking StatementsThis 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," "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, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. 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 annual report on Form 10-K for the year ended April 30, 2024, 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. View source version on Contacts Ryan BakerHead, Investor Relations(617) Molly CameronDirector, Corporate Communications(978)
Business Wire
02-06-2025
- Health
- Business Wire
KalVista Pharmaceuticals Medical Congress Presentations Highlight Potential of Sebetralstat to Redefine Hereditary Angioedema Management
CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced new sebetralstat findings related to time to end of progression of hereditary angioedema (HAE) attacks, and the effectiveness of treatment of attacks considered the most debilitating by patients, mucosal attacks, and attacks that have progressed in severity after a treatment delay. These data were presented at two congresses taking place concurrently: the 14th C1-inhibitor Deficiency & Angioedema Workshop in Budapest, Hungary, and the Eastern Allergy Conference (EAC) in Palm Beach, Florida, from May 29–June 1, 2025. Time to End of Progression of Hereditary Angioedema Attacks Treated with Sebetralstat was presented by William Lumry, M.D., Clinical Professor of Internal Medicine at the University of Texas Southwestern Medical School in Dallas and Director at Allergy and Asthma Research Associates, Dallas, Texas, United States. Time to end of attack progression (n=1591 attacks) in KONFIDENT-S: median 19.8 minutes Results from the open-label extension (KONFIDENT-S) aligned closely with the pivotal phase 3 trial, KONFIDENT, reinforcing the rapid effect of sebetralstat after absorption 'Stopping the progression of an HAE attack as early as possible is paramount to mitigating its impact on patients,' said Dr. Lumry. 'In both the KONFIDENT and KONFIDENT-S studies, sebetralstat halted attack progression in a median time of 19.8 minutes. As prior data have demonstrated near-complete plasma kallikrein inhibition 15 minutes after treatment, this analysis reveals that attacks are halted minutes after absorption. The consistency of findings across the KONFIDENT and KONFIDENT-S trials underscores the potential of sebetralstat as an effective and rapid-acting on-demand treatment for HAE attacks.' Effectiveness of sebetralstat for the on-demand treatment of mucosal hereditary angioedema attacks: interim analysis from KONFIDENT-S was presented by Henriette Farkas, M.D., PhD, DSc, Professor of Allergology and Clinical Immunology at Semmelweis University and Head of the Hungarian Angioedema Center of Reference and Excellence, Budapest, Hungary. Patients were able to self-administer sebetralstat quickly, with a median time to treatment of 20 minutes for abdominal attacks and 11.5 minutes for laryngeal attacks The median time to beginning of symptom relief was 1.3 hours for both abdominal and laryngeal attacks Of attacks reaching symptom relief within 12 hours, 96% did so before or without the need for an additional sebetralstat administration Sebetralstat was well-tolerated, even in laryngeal attacks, with no reported difficulties swallowing the oral tablet 'Mucosal HAE attacks, particularly those affecting the larynx, are a significant concern for patients and clinicians due to the risk of rapid progression and severe consequences, including the possibility of asphyxiation if left untreated,' said Dr. Farkas. 'These interim data from KONFIDENT-S demonstrate that sebetralstat provided rapid relief and resolution of both abdominal and laryngeal attacks with a favorable safety profile. Patients were able to self-administer sebetralstat very early in the course of an attack, when most attacks were still mild or moderate in severity.' Effectiveness of Sebetralstat for Severe or Very Severe Hereditary Angioedema Attacks in KONFIDENT-S was presented by H. Henry Li, M.D., Director of Immunology at the Institute for Asthma and Allergy, Wheaton, Maryland, United States. Sebetralstat was used to treat 76 attacks that had progressed to severe or very severe after a median of 2.16 hours from attack onset, demonstrating its utility in more advanced stages of HAE attacks The median time to beginning of symptom relief for these attacks was 1.36 hours, with reduction in attack severity and substantial reduction of symptom burden in a median of 1.77 hours and 9.15 hours, respectively 'When attacks are not treated early in accordance with guidelines, they can escalate and become severe,' said Dr. Li. 'We conducted this analysis of KONFIDENT-S to assess the utility of sebetralstat in more advanced stages of attacks that were associated with delayed treatment. Sebetralstat delivered symptom relief in a median time of 1.36 hours, reinforcing its potential as an on-demand treatment for challenging attack scenarios.' 'These new data underscore the potential of sebetralstat to fundamentally change HAE attack management," stated Paul Audhya, M.D., MBA, Chief Medical Officer of KalVista. "Even in real-world, high-stakes scenarios—be it mucosal attacks or severe attacks due to delayed treatment—sebetralstat consistently delivered rapid and reliable relief. The uniformity of these results, paired with an oral tablet formulation, solidifies our belief that sebetralstat can empower patients to act swiftly and recover quickly. We remain committed to bringing this innovative therapy to the HAE community as quickly as possible.' Links to all presentations can be found on the KalVista website under Publications. About Sebetralstat Sebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older, with ongoing studies exploring its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide. 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. All currently approved on-demand treatment options require either intravenous or subcutaneous administration. About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities. For more information about KalVista, please visit or follow us on social media at @KalVista and LinkedIn. 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," "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, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. 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 annual report on Form 10-K for the year ended April 30, 2024, 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.
Yahoo
22-05-2025
- Health
- Yahoo
KalVista Pharmaceuticals to Present New Sebetralstat Data With 10 Abstracts Accepted at Upcoming Medical Meetings
CAMBRIDGE, Mass. & SALISBURY, England, May 22, 2025--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that it will present new sebetralstat data at two upcoming congresses taking place concurrently from May 29–June 1, 2025: the 14th C1-inhibitor Deficiency & Angioedema Workshop in Budapest, Hungary, and the Eastern Allergy Conference (EAC) in Palm Beach, Florida. The presentations will include new findings on the potential of sebetralstat to rapidly relieve symptoms and halt progression of hereditary angioedema (HAE) attacks, including mucosal and severe cases, underscoring the importance of early intervention and the role of an oral on-demand treatment option. Details of the presentations are as follows: C1-inhibitor Deficiency & Angioedema Workshop The following poster presentations will take place during Poster Session I on Friday, May 30, from 3:45–5:30 pm CEST (9:45–11:30 am ET): In their own words, patient perspectives on time to feeling in control of an HAE attack (P-18): Doug Jones, Anna Valerieva, Mar Guilarte, Neil Malloy, Sally van Kooten, Markus Heckmann, Markus Magerl. Time to end of progression of hereditary angioedema attacks treated with sebetralstat (P-25): William R. Lumry, John Anderson, Jonathan A. Bernstein, Mauro Cancian, Danny M. Cohn, Henriette Farkas, Henry Li, James Hao, Michael Smith, Paolo Bajcic, Paul Audhya, Markus Magerl. Impact of injectable HAE on-demand treatments on health-related quality of life: a patient and caregiver interview study (P-29): Patrick Yong, Aleena Banerji, Paula Busse, Timothy Craig, Sorena Kiani-Alikhan, Rebekah Hall, Siu Hing Lo, Caleb Dixon, Paul Audhya, Alice Wang, Tomaz Garcez. The following oral presentation will take place during Scientific Session III on Saturday, May 31, from 2:30–2:45 pm CEST (8:30–8:45 am ET): Effectiveness of sebetralstat for the on-demand treatment of mucosal hereditary angioedema attacks: interim analysis from KONFIDENT-S (O-29): Jonathan A. Bernstein, Emel Aygören-Pürsün, Vesna Grivcheva-Panovska, Inmaculada Martinez-Saguer, Danny M. Cohn, William R. Lumry, Marc A. Riedl, Andrea Zanichelli, Laurence Bouillet, Ya-Hsiu Chuang, Michael D. Smith, Christopher M. Yea, Paul K. Audhya, Henriette Farkas. The following oral presentation will take place during Scientific Session V on Saturday, May 31, from 3:15–3:30 pm CEST (9:15–9:30 am ET): Anxiety associated with hereditary angioedema attacks: results from the phase 3 KONFIDENT trial of oral sebetralstat (O-32): Timothy J. Craig, Emel Aygören-Pürsün, Jonathan A. Bernstein, Paula J. Busse, Teresa Caballero, Danny M. Cohn, Mar Guilarte, Henriette Farkas, Douglas H. Jones, Sorena Kiani-Alikhan, Michael E. Manning, Marcus Maurer, Marc A. Riedl, Sinisa Savic, H. James Wedner, Patrick F. K. Yong, Andrea Zanichelli, Erik Hansen, James Hao, Michael D. Smith, Christopher M. Yea, Paul K. Audhya, William R. Lumry. The following poster presentation will take place during Poster Session II on Saturday, May 31, from 4:15–5:45 pm CEST (10:15–11:45 am ET): Survey results from Italy, the US, UK, and France: Anxiety in patients using injectable on-demand treatments for hereditary angioedema attacks (P-32): Mauro Cancian, Alexis Bocquet, Paula J. Busse, Timothy Craig, Tariq El-Shanawany, Tomaz Garcez, Padmalal Gurugama, Rashmi Jain, Sorena Kiani-Alikhan, Maeve O'Connor, Cristine Radojicic, Sinisa Savic, Paola Triggianese, H. James Wedner, Patrick Yong, Andrea Zanichelli, Vibha Desai, Julie Ulloa, Sherry Danese, Paul K. Audhya, Sandra Christiansen. KalVista is also sponsoring a pre-workshop symposium for healthcare professionals on Thursday, May 29, from 1:00–2:00 pm CEST (7:00–8:00 am ET) in the Magnolia room, titled "Interplay Between On-Demand Treatment Guidelines and Clinical Trials in HAE." Chaired by Dr. William Lumry, Clinical Professor of Internal Medicine at the University of Texas Southwestern Medical School and Medical Director of AARA Research Center, this symposium will highlight insights from Dr. Mauro Cancian (University Hospital of Padova, Italy) and Dr. Danny Cohn (University of Amsterdam, Netherlands), addressing the evolution of on-demand treatment guidelines in HAE, real-world challenges in guideline adherence, and advancements in clinical trial designs to support guideline adherence. EAC The following poster presentations will take place on Saturday, May 31, from 9:45–11:00 am ET: Effectiveness of Sebetralstat for Severe or Very Severe Hereditary Angioedema Attacks in KONFIDENT-S: Henry Li, William R. Lumry, Michael E. Manning, Marc A. Riedl, James Wedner, James Hao, Michael D. Smith, Paul K. Audhya, Jonathan A. Bernstein. On-demand Treatment of Hereditary Angioedema Attacks with Sebetralstat in Older Adults: Interim Analysis from KONFIDENT-S: Daniel F. Soteres, Alan P. Baptist, Jonathan A. Bernstein, Timothy Craig, William R. Lumry, James Hao, Michael D. Smith, Paolo Bajcic, Paul K. Audhya, Marc A. Riedl. Time to End of Progression of Hereditary Angioedema Attacks Treated with Sebetralstat: Daniel F. Soteres, William R. Lumry, John Anderson, Jonathan A. Bernstein, Mauro Cancian, Danny M. Cohn, Henriette Farkas, Henry Li, James Hao, Michael D. Smith, Paolo Bajcic, Paul K. Audhya, Markus Magerl. Long-Term Prophylaxis Compliance and Healthcare Resource Utilization in Hereditary Angioedema: A Claims Database Analysis: Raffi Tachdjian, Daniel F. Soteres, Maeve O'Connor, Chirag Maheshwari, Alice Wang, Paul K. Audhya, Timothy Craig. Links to all presentations can be found on the KalVista website under Publications. About SebetralstatSebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older, with ongoing studies exploring its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide. About Hereditary AngioedemaHereditary 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. All currently approved on-demand treatment options require either intravenous or subcutaneous administration. About KalVista Pharmaceuticals, Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities. For more information about KalVista, please visit or follow us on social media at @KalVista and LinkedIn. Forward-Looking StatementsThis 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," "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, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. 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 annual report on Form 10-K for the year ended April 30, 2024, 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. View source version on Contacts Ryan BakerHead, Investor Relations(617) Molly CameronDirector, Corporate Communications(857) Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
