Summary of RAPID-3 Topline Data Webcast Company and Industry - **Company**: Pharvaris - **Industry**: Biotechnology, specifically focusing on treatments for Hereditary Angioedema (HAE) Core Points and Arguments 1. **Introduction of Deucrictibant**: The RAPID-3 study is a phase 3 clinical trial for deucrictibant, an immediate release capsule designed for on-demand treatment of hereditary angioedema attacks [2][6] 2. **Study Design**: RAPID-3 was a double-blind crossover study involving 124 adults and 10 adolescents, treating various severities of HAE attacks [13][14] 3. **Diversity of Participants**: The study included a diverse population with approximately 70% Caucasians, over 14% Asians, and around 7% Black or African Americans, making it the most representative HAE study to date [14] 4. **Efficacy Results**: Deucrictibant demonstrated a median time to onset of symptom relief of 1.28 hours, significantly faster than placebo, which had a median time of over 12 hours [16][19] 5. **Substantial Symptom Relief**: 85% of deucrictibant-treated attacks achieved symptom relief within four hours, compared to around 30% for placebo [17] 6. **End-of-Progression Milestone**: The end-of-progression was achieved within 17.5 minutes for deucrictibant-treated attacks, indicating rapid absorption and effectiveness [18] 7. **Safety Profile**: Deucrictibant was well tolerated, with most adverse events being mild or moderate. There were no significant safety signals identified [19][20] 8. **Market Positioning**: Deucrictibant's dual formulation for both on-demand and prophylactic treatment is seen as a strategic advantage, potentially enhancing market share and patient adoption [24][25] 9. **Future Plans**: Pharvaris aims to submit for global marketing authorization for deucrictibant in the on-demand treatment of HAE attacks in 2026 [22][37] Other Important Content 1. **Unmet Needs in HAE Treatment**: Despite advancements in long-term prophylactic treatments, there remains a critical need for effective on-demand therapies due to the unpredictable nature of HAE attacks [9][10] 2. **Patient-Centric Approach**: The development of deucrictibant aligns with the company's mission to provide patient choice and reduce treatment burden [25][26] 3. **Upcoming Data Presentations**: Further data from the RAPID-3 study will be presented at the AAAAI conference in February 2024, with additional studies planned for the prophylactic treatment of HAE [26][37] 4. **CYP3A4 Interaction**: Deucrictibant is primarily metabolized by CYP3A4, and caution is advised when used with strong CYP3A4 inhibitors or inducers [32] 5. **Patient Preferences**: A significant majority (80%-85%) of patients expressed interest in switching to oral rescue treatments, although some may prefer injectable options due to familiarity and perceived effectiveness [50] This summary encapsulates the key findings and strategic insights from the RAPID-3 Topline Data webcast, highlighting the potential impact of deucrictibant on the treatment landscape for hereditary angioedema.

Summary of KalVista Pharmaceuticals Conference Call Company Overview - **Company**: KalVista Pharmaceuticals - **Product**: Ekterly, an oral therapy for the on-demand treatment of acute attacks of Hereditary Angioedema (HAE) - **FDA Approval**: Received in July 2025, with a launch shortly thereafter [4][5] Key Points Product Launch and Market Penetration - **Patient Adoption**: Over 1,000 patients currently on Ekterly, representing over 10% of the market, with expectations to reach 12-13% [5][6] - **Treatment Guidelines**: Ekterly encourages early treatment of attacks, aligning with guidelines that suggest treating all attacks, even mild ones [6][7] - **Patient Satisfaction**: High satisfaction reported among patients, attributed to the convenience of oral administration [7] Prescription and Refill Mechanics - **Initial Prescription Process**: Patients receive a free drug sample and then transition to commercial coverage, which may take 6-8 weeks initially [10][14] - **Refill Rates**: Patients with severe disease (15-20% of the population) are the highest users, refilling every 3-4 weeks [17][18] - **Stockpiling**: Patients are expected to stockpile Ekterly due to its convenience, although dramatic stockpiling is not anticipated [28][29] Market Dynamics and Competition - **Market Transition**: The market is expected to shift towards oral therapies, reducing the reliance on injectables [24][44] - **Pharvaris Competition**: Upcoming data from Pharvaris is viewed as a data event for investors but is not expected to impact KalVista's commercial trajectory significantly [38][39] - **Market Leadership**: Confidence expressed in maintaining market leadership post-Pharvaris entry due to patient satisfaction and the advantages of Ekterly [44] International Expansion - **Global Launch Plans**: First shipment to Germany in October 2025, with launches in the U.K. and Japan expected in early 2026 [46] - **Pricing Strategy**: International pricing is anticipated to be significantly lower than U.S. pricing, with estimates around 20% of U.S. prices [48][52] Pediatric Market Insights - **Pediatric Need**: Approximately 500 pediatric patients in the U.S. with HAE, highlighting an unmet need for non-injectable therapies [57][58] - **Efficacy in Pediatrics**: Initial data shows that pediatric patients experience similar efficacy and safety profiles as adults, with previously unrecognized higher attack rates [59][60] Additional Insights - **Patient Services**: Robust patient services are in place, contributing to high patient retention and satisfaction [33] - **Safety Profile**: No significant adverse events reported post-launch, maintaining a pristine safety profile [35] This summary encapsulates the key aspects of KalVista Pharmaceuticals' conference call, focusing on the company's product, market dynamics, and future outlook.

KalVista Pharmaceuticals (NasdaqGM:KALV) Q3 2025 Earnings Call November 11, 2025 08:30 AM ET Company ParticipantsBen Palleiko - CEONicole Sweeny - Chief Commercial OfficerBrian Piekos - CFOPaul Audia - CMORyan Baker - Head of Investor RelationsConference Call ParticipantsNone - AnalystNone - AnalystJoe Schwartz - AnalystStacy Ku - AnalystDebanjana Chatterjee - AnalystMaury Raycroft - AnalystNone - AnalystOperatorThank you for standing by. Welcome to KalVista Pharmaceuticals' 2025 third-quarter financial upd ...

Financial Data and Key Metrics Changes - Sales of EKTERLY reached $13.7 million for the launch period through September 30, which includes $1.4 million recorded in July [21] - Total operating expenses for the period were $59.7 million, consisting of approximately $12 million in R&D expenses and approximately $46.5 million in SG&A expenses [23] - Gross to net came in toward the low end of the expected range this quarter, driven largely by lower copay utilization typical for this time of year [23] Business Line Data and Key Metrics Changes - The U.S. launch of EKTERLY has seen strong adoption, with 937 start forms received, representing over 10% of the HAE community [15] - The average number of cartons per shipment is on the high end of expected ranges, aligning with utilization among high-burden patients [22] - Patients refilling prescriptions are doing so every three to four weeks, indicating a growing reliance on EKTERLY [17] Market Data and Key Metrics Changes - The approval footprint for EKTERLY continues to grow, with recent approvals in Australia, Germany, and ongoing discussions for launches in the U.K. and Japan [5][19] - Awareness levels among healthcare providers are exceptionally high, with 100% of tier one HCPs and 95% of all target HCPs reporting awareness of EKTERLY [16] Company Strategy and Development Direction - The company aims to establish EKTERLY as the foundational therapy for HAE treatment, focusing on aggressive execution and scaling in the U.S. while expanding access globally [24] - The strategy includes evaluating optimal strategies to expand access in geographies where the company will not launch on its own, with more agreements anticipated [5] Management's Comments on Operating Environment and Future Outlook - Management is encouraged by the early momentum and rapid growth of EKTERLY, reinforcing the belief in its long-term success as market awareness continues to grow [24] - The company expects refill patterns to normalize as adoption expands beyond the highest burden patients [17] Other Important Information - The company has recently hired key personnel, including a Chief Operating Officer and a Chief People Officer, to support its growth [6] - The company is fully financed through profitability, allowing it to focus on executing the EKTERLY launch while evaluating additional growth opportunities [6] Q&A Session Summary Question: Trends for types of patients switching to EKTERLY - Management noted that roughly half of the patients who switched to EKTERLY self-report an attack rate of two or more attacks per month, indicating a high burden [27] Question: Proportion of paid versus free drug - The paid rate for EKTERLY continues to grow, with successful use of medical exceptions for access [31] Question: Refill rates for high-burden patients - Refill frequencies for high-burden patients are currently about once a month, significantly higher than the average for other therapies [38] Question: Insurance negotiations and payer policies - The company is seeing favorable policies being established by regional and national payers, with expectations to finalize discussions early in 2026 [73] Question: Revenue trajectory in the next couple of quarters - Initial fills are expected to continue, but refill rates may decline as the burden of disease on patients decreases [75]

Financial Data and Key Metrics Changes - The company reported $1.4 million in net revenue for EKTERLY during the launch period, primarily from stocking orders by specialty pharmacies [13] - Total operating expenses for the period were $60.4 million, with approximately $15 million in R&D expenses and $45 million in SG&A expenses, driven by external spending related to the EKTERLY launch [13] - The company had approximately $191 million in cash and investments as of July 31, 2025, expected to fund operations into 2027 [14] Business Line Data and Key Metrics Changes - EKTERLY is positioned as the first and only oral on-demand therapy for acute HAE attacks, with initial launch metrics showing that nearly 5% of the U.S. HAE population has submitted a prescription [4][7] - The company has activated 253 unique prescribers, with 38% starting multiple patients on EKTERLY [11] - Early demand has come from patients previously on other therapies, with strong interest from a broad base of providers [11][12] Market Data and Key Metrics Changes - In Europe, sebetralstat received a positive CHMP opinion for the treatment of acute HAE attacks, with a final decision expected in October [7] - The UK MHRA granted marketing authorization for EKTERLY, with a commercial launch anticipated in the first half of 2026 [8] - The company is progressing towards anticipated approval in Japan by the end of the year [8] Company Strategy and Development Direction - The company aims to transform the treatment paradigm for HAE with EKTERLY, focusing on global expansion and establishing it as the foundational therapy for HAE [4][15] - The management emphasizes the importance of executing a disciplined commercial strategy and driving meaningful long-term value creation for shareholders [8][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong early response to EKTERLY, highlighting the unmet need in HAE and the transformational potential of the therapy [15] - The company anticipates that operating expenses will remain consistent as they continue to invest in the EKTERLY launch [13] Other Important Information - The company is changing its fiscal year end to December 31, starting with the quarter ending September 30, 2025 [14] - The quick start program provides immediate access to EKTERLY at no charge while working with physician offices to gain paid access [19][29] Q&A Session Summary Question: Can you further speak to the quick start program and expectations for timing to paid drug? - The quick start program provides immediate access to EKTERLY at no charge, with efforts to gain paid access through medical exceptions [19][20] Question: How many of the 4,000 patients in the database are individual patients or caregivers? - The majority of patients in the database are individual patients, with efforts to engage them through local education programs [23] Question: What are your expectations for launch metrics moving forward? - The company plans to share more KPIs as the launch progresses, including repeat prescribers and utilization rates [28] Question: Can you provide a breakdown of the 460 start forms? - All 460 start forms received quick start access, with some paid shipments already going out [34] Question: What feedback have you received regarding side effects observed so far? - Adverse events reported have been minimal, with no significant GI-related issues noted during the launch [37][38]