Financial Data and Key Metrics Changes - The company reported $1.4 million in net revenue for the launch period, primarily from stocking orders by specialty pharmacies [12] - 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, reflecting a quarter-over-quarter increase in SG&A driven by external spending related to the ECTERLEET launch [12][13] - The company had approximately $191 million in cash and investments as of July 31, 2025, which is expected to fund operations into 2027 [13][14] Business Line Data and Key Metrics Changes - ECTERLEET is positioned as the first and only oral on-demand therapy for acute hereditary angioedema (HAE) attacks, with initial launch metrics showing that nearly 5% of the entire U.S. HAE population has submitted a prescription [4][6] - The company has activated 253 unique prescribers, with 38% starting multiple patients on ECTERLEET, indicating strong early adoption [10] - The field sales team has reached over 72% of the total physician base, including 96% of tier one physicians [11] 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, and a staged launch anticipated over the next 12 to 18 months [6] - The UK MHRA granted marketing authorization for ECTERLEET, with a commercial launch expected in the first half of 2026 [7] - The company is progressing towards anticipated approval in Japan by the end of this year [7] Company Strategy and Development Direction - The company aims to redefine the standard of care for HAE with ECTERLEET, focusing on executing its commercial strategy with discipline and driving global expansion [15] - The management emphasizes the importance of early treatment and adherence to treatment guidelines to achieve total disease control for HAE patients [5] - The company is also exploring partnerships for regulatory filings in Canada and discussions with potential partners worldwide [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong response to ECTERLEET, highlighting the rapid adoption and engagement from patients and physicians [15] - The company anticipates that operating expenses will remain consistent as it continues to invest in the ECTERLEET launch [12] - Management noted that the early demand for ECTERLEET has exceeded expectations, indicating a broad interest across various patient demographics [42] Other Important Information - The company is transitioning its fiscal year end to December 31, with the next reporting period capturing the three-month period from July through September [14] - The management team includes key executives such as the CEO, CCO, and CFO, who are actively involved in the call [2][3] 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 ECTERLEET at no charge while pursuing medical exceptions for paid access [19][20] Question: How many of the 4,000 patients and caregivers signed up for ECTERLEET updates are individual patients? - The majority of the 4,000 individuals in the database are patients, with caregivers also included [23] Question: What are the expectations for launch metrics moving forward? - The company plans to share more detailed KPIs as the launch progresses, including actual doses prescribed [25][27] Question: Can you provide a breakdown of the 460 start forms? - All 460 start forms received quick start access, and paid shipments have started going out to patients [33] Question: Any feedback on side effects observed so far? - Adverse event reports have been minimal, with no significant GI-related adverse events reported [36][38] Question: What is the expected cadence for shifting patients from OLE to commercially reimbursed scripts? - The transition from OLE to commercial scripts is gradual, with no dramatic immediate shifts expected [56] Question: What are the expectations for formulary coverage? - The company anticipates parity access to branded therapies, with ongoing efforts to secure coverage [66]

KalVista Pharmaceuticals, Inc. (KALV) came out with a quarterly loss of $1.12 per share versus the Zacks Consensus Estimate of a loss of $0.91. This compares to a loss of $0.87 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -23.08%. A quarter ago, it was expected that this company would post a loss of $0.77 per share when it actually produced a loss of $0.99, delivering a surprise of -28.57%.Over the last four quarters, the c ...

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Product Approval and Market Authorization - EKTERLY (sebetralstat) received FDA approval on July 3, 2025, becoming the first and only oral, on-demand therapy for hereditary angioedema (HAE) in patients aged 12 years and older[81] - The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK granted marketing authorization for EKTERLY in July 2025, providing up to 10 years of market exclusivity[83] - The European Medicines Agency (EMA) adopted a positive opinion for sebetralstat, with a final decision from the European Commission expected in October 2025[84] Financial Performance - Product revenue for the three months ended July 31, 2025, was $1.426 million, compared to zero for the same period in 2024, due to the commercial launch of EKTERLY[88] - Net cash used in operating activities was $54.5 million for the three months ended July 31, 2025, compared to $40.2 million for the same period in 2024, reflecting a significant increase in net loss adjustments[103] - The net loss for the three months ended July 31, 2025, was $60.0 million, adjusted for stock-based compensation and other factors, compared to a net loss of $40.4 million in the same period in 2024[103] Expenses - Research and development expenses decreased by $11.452 million to $15.162 million for the three months ended July 31, 2025, primarily due to reduced spending on EKTERLY and other R&D activities[90] - Selling, general and administrative expenses increased by $27.082 million to $44.683 million for the three months ended July 31, 2025, driven by higher personnel costs and commercial expenses[92] - Total operating expenses for the three months ended July 31, 2025, were significantly impacted by the increase in selling, general and administrative expenses, reflecting the company's focus on commercialization efforts[92] Cash Flow and Financing - Net cash provided by investing activities was $21.3 million for the three months ended July 31, 2025, down from $37.2 million in the prior year, primarily due to changes in marketable securities transactions[104] - Net cash provided by financing activities increased to $23.2 million in the three months ended July 31, 2025, compared to $3.0 million in the same period in 2024, driven by a milestone payment related to FDA approval[105] - The company reported a net decrease in cash, cash equivalents, and restricted cash of $7.3 million for the three months ended July 31, 2025, contrasting with a slight increase of $59,000 in the prior year[102] Contracts and Accounting - The company has ongoing contracts with research organizations and clinical trial sites, which are generally cancelable and not included in the contractual obligations table[106] - There have been no material changes to the company's critical accounting estimates in the three months ended July 31, 2025[107] - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[109] Licensing and Partnerships - KalVista Pharmaceuticals received a one-time payment of $22 million from DRI Healthcare following FDA approval, increasing the royalty rate on net sales up to $500 million from 5% to 6%[87] - The company entered into a License, Supply and Distribution Agreement with Kaken Pharmaceutical for exclusive commercialization rights in Japan, receiving an upfront payment of $11 million[100] Royalty Liabilities - The company experienced a significant increase in the royalty liability of $22.0 million related to the drawdown of the milestone payment after FDA approval of EKTERLY[105]

Exhibit 99.1 KalVista Pharmaceuticals Provides Operational Update and Reports Fiscal Quarter Financial Results -EKTERLY® now approved in the US and UK; first and only oral on-demand therapy for acute attacks of hereditary angioedema- -Initiated US EKTERLY launch in July; received 460 patient start forms through August- -European Medicines Agency adopted a positive opinion recommending approval of sebetralstat and confirmed maintenance of orphan designation in EU; decision expected early October- -$191M in c ...

Group 1 - KalVista Pharmaceuticals is set to release its first-quarter earnings results on September 11, with analysts expecting a loss of $0.96 per share compared to a loss of $0.87 per share in the same quarter last year [1] - The company is projected to report quarterly revenue of $2.09 million [1] - On August 11, KalVista announced the maintenance of Orphan Designation for Sebetralstat in the European Union [2] Group 2 - KalVista Pharmaceuticals shares experienced a decline of 2.2%, closing at $15.61 [2] - Analysts have provided various ratings for KalVista, with HC Wainright & Co. maintaining a Buy rating and a price target of $27 [4] - JMP Securities increased its price target for KalVista from $19 to $27 while maintaining a Market Outperform rating [4]

Negative Earnings: Analysts predict an EPS of -$0.91 and revenue of approximately $2.1 million.Financial Challenges: Despite a P/E ratio of -4.32, challenges in generating positive cash flow are evident, with an enterprise value to operating cash flow ratio of -4.61.Strong Liquidity: KalVista maintains a current ratio of 5.35, indicating a strong liquidity position to cover short-term liabilities.KalVista Pharmaceuticals, Inc. (NASDAQ:KALV) is a biopharmaceutical company focused on developing small molecule ...

Company Overview - KalVista Pharmaceuticals is a newly commercial stage pharmaceuticals company [2] - The company has launched its drug EKTERLY for the treatment of acute attacks of hereditary angioedema, which was approved by the FDA in early July [2] Product Launch and Approvals - EKTERLY was launched immediately after FDA approval and the company closed its first fiscal quarter as a commercial entity on July 31 [2] - The drug has also received approval from the U.K. MHRA and is set to launch in the U.K. next year [3] - The CHMP in the EU recommended approval for EKTERLY at the end of July, with formal approval expected in October [3] - KalVista is pursuing approvals in four additional countries, indicating a strategy for global expansion [3]

Market Overview - U.S. stock futures are lower, with Dow futures down approximately 100 points on Monday [1] - Ultragenyx Pharmaceutical Inc. shares fell 8% to $27.15 after receiving a Complete Response Letter from the FDA for its gene therapy UX111 [1] Company-Specific Movements - MiNK Therapeutics, Inc. shares dropped 31% to $44.25 after a significant 730% increase on Friday due to a publication announcement [3] - Above Food Ingredients Inc. shares decreased 21.3% to $2.84 following a 134% rise on Friday after announcing a merger agreement [3] - Newegg Commerce, Inc. shares fell 11.3% to $43.66 after a 71% gain on Friday [3] - CEL-SCI Corporation shares declined 11% to $3.08 after an 8% drop on Friday, following a partnership announcement with a Saudi Arabian company [3] - Unusual Machines, Inc. shares slipped 8% to $11.13 after a 39% increase on Friday [3] - Gossamer Bio, Inc. shares fell 6.6% to $1.2700 after completing enrollment in a Phase 3 study for pulmonary arterial hypertension [3] - Gilat Satellite Networks Ltd. shares decreased 4.1% to $7.22 after announcing over $22 million in orders from satellite operators [3] - KalVista Pharmaceuticals, Inc. shares dipped 4% to $13.94 after reporting a wider-than-expected quarterly loss [3] - Apple Inc. shares fell 1% to $209.22 amid a significant management reshuffle, with CEO Tim Cook remaining in charge despite challenges [3]

Core Insights - KalVista Pharmaceuticals' shares have increased by 36% following the FDA's approval of its lead drug, sebetralstat, for hereditary angioedema (HAE) [1][6] - Sebetralstat, marketed as Ekterly, is the first oral on-demand therapy for HAE, marking a significant milestone for KalVista as it transitions into a commercial-stage biotech [2][6] Company Overview - Ekterly is designed for the treatment of acute HAE attacks in individuals aged 12 and older, providing a more convenient alternative to existing injectable treatments [2][5] - The approval of Ekterly allows KalVista to tap into a niche but lucrative market, potentially generating recurring revenue [2] Stock Performance - Year-to-date, KalVista's shares have surged by 89%, significantly outperforming the industry average growth of 5% [3] Treatment Paradigm Shift - Ekterly's oral formulation offers a game-changing advancement in HAE treatment, allowing for timely administration at the onset of symptoms, which is crucial for effective management [5][7] - The drug's safety profile is favorable compared to Takeda's Kalbitor, which has a boxed warning for anaphylaxis, potentially influencing prescribing decisions [8][9] Clinical Data - The FDA approval was supported by data from the KONFIDENT study, which demonstrated that Ekterly provided faster symptom relief and reduced attack severity compared to placebo [9] - KalVista is also conducting a phase III study, KONFIDENT-KID, to evaluate Ekterly in pediatric patients aged 2-11, with results expected later this year [10]