Drug Development and Regulatory Submissions - KalVista submitted a New Drug Application (NDA) for sebetralstat to the FDA in June 2024, aiming for approval and launch in the US in the first half of 2025[1]. - The KONFIDENT phase 3 trial results for sebetralstat were published in the New England Journal of Medicine, supporting its potential as a therapy for hereditary angioedema (HAE) attacks[1]. - The company is on track for Market Authorization Application submissions to the European Medicines Agency and UK Medicines and Healthcare Products Regulatory Agency in Q3 2024[7]. - A pediatric clinical trial (KONFIDENT-KID) for sebetralstat is underway, enrolling approximately 24 children aged 2 to 11 years across seven countries[1]. - KalVista plans to submit a JNDA to the Japanese Pharmaceuticals and Medical Devices Agency in Q4 2024[8]. - The company is evaluating the potential for further development of its preclinical Factor XIIa inhibitor program[9]. Financial Performance - Net loss for the fiscal year ended April 30, 2024, was $126.6 million, or $(3.44) per share, compared to a net loss of $92.9 million, or $(3.33) per share in the prior fiscal year[5]. - The net loss for the three months ended April 2024 was $(44,650,000), compared to a net loss of $(26,305,000) in the same period last year, indicating a deterioration of 70%[25]. - The net loss per share, basic and diluted, was $(1.02) for April 2024, compared to $(0.77) for April 2023, representing a decline of 32.5%[25]. - The company reported a total operating loss of $48,455,000 for the three months ended April 2024, compared to $31,728,000 for the same period last year, an increase of 52.7%[25]. Expenses - Research and development expenses increased to $86.2 million for the fiscal year ended April 30, 2024, up from $80.3 million in the prior fiscal year, primarily due to the KONFIDENT trial[5]. - General and administrative expenses rose to $54.3 million for the fiscal year ended April 30, 2024, compared to $30.6 million in the prior fiscal year, driven by employee-related and commercial planning expenses[5]. - Research and development expenses for the three months ended April 2024 were $25,248,000, up from $23,951,000 in the same period last year, an increase of 5.4%[25]. - General and administrative expenses surged to $23,207,000 in April 2024, compared to $7,777,000 in April 2023, reflecting a significant increase of 198%[25]. Assets and Liabilities - Cash, cash equivalents, and marketable securities totaled $210.4 million on April 30, 2024, compared to $149.4 million on April 30, 2023, reflecting proceeds from a February 2024 stock offering[5]. - Total current assets increased to $225,690,000 in April 2024 from $172,326,000 in April 2023, representing a growth of 31%[23]. - Total liabilities increased to $28,822,000 in April 2024 from $22,177,000 in April 2023, marking a rise of 30%[23]. - Stockholders' equity rose to $206,582,000 in April 2024, up from $161,025,000 in April 2023, an increase of 28.2%[23]. Other Income and Shares - Total other income decreased to $3,805,000 in April 2024 from $5,423,000 in April 2023, a decline of 30%[25]. - Weighted average common shares outstanding increased to 43,590,657 in April 2024 from 34,342,664 in April 2023, an increase of 27%[25].

Financial Performance and Losses - The company has incurred significant operating losses since inception and expects to continue incurring losses for the foreseeable future[112]. - Additional funding will be necessary to support ongoing operations and product development, which may lead to dilution of stockholder ownership[117]. - The company has not yet commercialized any product candidates and does not expect to generate product revenues for many years[118]. - The company anticipates that approximately $76.7 million of its net operating losses (NOLs) will go unutilized due to past ownership changes, limiting future tax benefits[234]. - The company’s ability to utilize NOLs is contingent upon achieving profitability and generating taxable income, which remains uncertain[234]. - The company has incurred significant costs due to operating as a public entity, including legal, accounting, and compliance expenses, which may affect financial performance[223]. Regulatory and Approval Challenges - An NDA for sebetralstat as an on-demand HAE therapy was submitted to the FDA in June 2024, targeting adults and adolescents over age 12[113]. - The company has not yet demonstrated the ability to obtain marketing approvals[121]. - The regulatory approval process is expensive and can take many years, with no guarantee of approval, which could materially harm the company's financial condition[130]. - The FDA has granted orphan drug designation for sebetralstat, which may not effectively protect it from competition as it does not preclude different drugs from being approved for the same condition[139]. - The company must obtain separate marketing approvals in jurisdictions outside the U.S., which may involve additional testing and regulatory requirements[141]. - The approval of a product candidate in one jurisdiction does not guarantee approval in other jurisdictions, which could limit the company's market opportunities[141]. - The FDA's fast track designation for sebetralstat does not guarantee a faster development or approval process[140]. - The company may face significant penalties if found in violation of healthcare laws and regulations, which could adversely affect its financial results[136]. Clinical Development and Trials - The company anticipates substantial increases in expenses related to clinical development, marketing approvals, and commercialization efforts[116]. - Delays in clinical trials could lead to increased development costs and negatively impact the company's ability to secure additional financing[127]. - The company may face challenges in patient enrollment for clinical trials, particularly due to the rarity of HAE[126]. - The company expects to conduct ongoing clinical trials, including the KONFIDENT-KID trial for sebetralstat, but is dependent on third parties for timely execution[190]. - There are risks associated with investigator-sponsored trials, including lack of control over design and execution, which could lead to delays in clinical development[192]. Market and Competitive Landscape - The company faces substantial competition from larger pharmaceutical and biotechnology firms, which may have greater resources and expertise[164]. - Market acceptance of product candidates is uncertain and depends on factors such as efficacy, safety, and competitive pricing[160]. - The uncertainty surrounding insurance coverage and reimbursement for newly approved products could limit the company's ability to market these products and generate revenue[165]. - The company may face significant pricing pressures due to governmental and third-party payors' efforts to cap healthcare costs, impacting reimbursement levels for new products[167]. Intellectual Property and Legal Risks - The company faces challenges in obtaining and maintaining intellectual property protection, which is essential for preventing competitors from commercializing similar technologies[195]. - The patent prosecution process is expensive and time-consuming, and the company may not be able to file all necessary patent applications in a timely manner[196]. - The company may be subject to challenges regarding its patent rights, which could reduce the scope of protection or invalidate patents[198]. - There is a risk of third-party legal proceedings alleging infringement of intellectual property rights, which could materially affect the company's business success[204]. - If found infringing on third-party intellectual property, the company may need to obtain licenses that could be costly or non-exclusive, impacting its competitive position[205]. Operational and Management Challenges - The company will need to transition from a research-focused entity to one capable of supporting commercial activities upon regulatory approval[115]. - Retaining key executives and qualified personnel is critical for the company's success, and losing them could delay product development[207]. - The company anticipates significant growth in operations, particularly in drug development and regulatory affairs, which may lead to management challenges[210]. - Strategic transactions, such as collaborations or acquisitions, may not yield expected synergies and could pose operational and financial risks[184]. External Factors and Risks - Changes in trade relations, particularly with Chinese biotechnology companies, could disrupt the supply of materials necessary for product development[179]. - The ongoing conflicts in Ukraine and the Middle East could potentially affect the company's clinical trial operations in Eastern Europe[236]. - Legislative initiatives at the state level are increasingly controlling pharmaceutical pricing, which could limit government payments for pharmaceuticals and reduce demand for future product candidates[150]. - Future healthcare reforms may impose more rigorous coverage criteria and downward pressure on prices, potentially affecting revenue generation and profitability[151]. Financial and Market Conditions - The company is exposed to foreign exchange rate risk, primarily incurring expenses in GBP, but does not engage in hedging activities[315]. - The company does not currently intend to pay dividends on its common stock, which means stockholders' returns will depend on future appreciation in stock price[240]. - The company’s financial results could be adversely affected by unstable global market conditions, including inflation and supply chain disruptions[235]. - Changes in tax laws, such as the TCJA and IRA, could materially affect the company's financial position and results of operations[237].

Core Insights - KALV's flagship drug candidate, Sebetralstat, is positioned to become the first oral therapy for acute hereditary angioedema (HAE), targeting a $900 million on-demand market and potentially expanding to a total addressable market (TAM) of $2.9 billion [5][12][14] - The company has submitted a New Drug Application (NDA) for Sebetralstat, with plans for additional regulatory submissions in the EU, UK, and Japan in the second half of 2024, aiming for a potential launch in 2025 [6][11] - KALV's recent equity offering raised $150.1 million, providing sufficient liquidity for commercialization efforts and extending the cash runway to approximately 2.2 years post-raise [7][8][11] Company Overview - KalVista Pharmaceuticals, established in 2011, focuses on developing oral small-molecule therapies for HAE, leveraging expertise in the Kallikrein-Kinin System (KKS) [12][13] - The company’s primary value driver is Sebetralstat, which has completed phase 3 clinical trials and is awaiting regulatory approval [12][14] - HAE is a rare genetic disease with an incidence of 1 in 10,000 to 1 in 50,000, affecting approximately 6,500 to 8,000 patients in the US [14] Financial Position - As of January 2024, KALV's balance sheet included approximately $23.1 million in cash, $52.5 million in marketable securities, and an R&D tax credit receivable of $23.0 million, totaling about $248.7 million in available short-term funds [7] - Following the recent equity raise, KALV's diluted shares outstanding increased from 34.7 million to 45.2 million, resulting in a fully diluted market cap of $530.9 million [7][8] - The company's book value post-raise is estimated at approximately $238.7 million, indicating a price-to-book (P/B) ratio of 2.2, slightly undervalued compared to the sector median of 2.32 [7][8] Market Potential - Sebetralstat's approval could significantly enhance KALV's competitive profile in the HAE market, which currently includes injectable alternatives [12][14] - The ongoing KONFIDENT-S trial aims to provide additional safety data, while the company is also preparing for a supplemental New Drug Application (sNDA) for orally disintegrating tablets (ODTs) [14] - KALV's strategic partnerships and research initiatives are designed to reduce R&D expenses and facilitate regulatory approval processes [4][6]

Clinical Trials and Drug Development - The Phase 3 KONFIDENT clinical trial for sebetralstat enrolled 136 patients across 66 clinical sites in 20 countries, making it the largest trial conducted for hereditary angioedema (HAE) to date[67]. - Sebetralstat demonstrated a median time to symptom relief of 1.61 hours for the 300 mg dose and 1.79 hours for the 600 mg dose, compared to 6.72 hours for placebo, achieving statistical significance (p<0.0001 for 300 mg, p=0.0013 for 600 mg)[68]. - The company plans to submit a New Drug Application (NDA) for sebetralstat to the FDA in the first half of 2024, with additional filings expected in the European Union and Japan later in 2024[69]. - The company has received Fast Track and Orphan Drug designations from the FDA for sebetralstat, along with Orphan Drug Designation from the European Medicines Agency[72]. - The company is developing an oral Factor XIIa inhibitor program, which targets a key enzyme in the HAE biochemical pathway, with potential future applications in other therapeutic areas[73]. - Research and development expenses for the sebetralstat program increased significantly due to ongoing Phase 3 trials, with expectations to maintain expenses at current levels[90]. Financial Performance and Revenue - The company has not generated any revenue in the current fiscal year and does not expect to do so until regulatory approval and commercialization of its product candidates[78]. - Revenue for the three months ended January 31, 2024, was $0, consistent with the same period in 2023[88]. - Other income decreased by $1.5 million to $4.1 million for the three months ended January 31, 2024, largely due to a reduction in research and development tax credits[95]. Expenses and Losses - Research and development expenses increased by $2.5 million to $22.5 million for the three months ended January 31, 2024, driven by personnel costs and sebetralstat spending[89]. - General and administrative expenses rose by $3.7 million to $10.6 million for the three months ended January 31, 2024, primarily due to employee-related expenses[94]. - For the nine months ended January 31, 2024, research and development expenses totaled $60.9 million, an increase of $4.6 million compared to the prior year[96]. - The net cash used in operating activities was $74.1 million for the nine months ended January 31, 2024, compared to $52.6 million in the same period in 2023[107]. - The company anticipates continued losses as it develops and seeks regulatory approvals for product candidates, with sufficient funding to operate for at least the next twelve months[111]. Capital and Financing - The company raised approximately $57.7 million from a registered direct offering of 9,484,199 shares at $6.00 per share in December 2022[74]. - An underwriting agreement was entered into on February 14, 2024, to sell 7,016,312 shares at $15.25 per share, with net proceeds expected to be approximately $150.1 million[76]. - The company expects to finance cash needs through equity and debt financings, collaborations, strategic partnerships, and licensing arrangements[112]. - Additional capital raised through stock or convertible debt may dilute existing stockholders' ownership interests[112]. - Debt financing may involve increased fixed payment obligations and covenants that restrict business operations[112]. Accounting and Reporting - Financial statements are prepared in accordance with U.S. GAAP, requiring estimates and assumptions that may affect reported amounts[114]. - Actual results may differ from estimates based on various factors, impacting the carrying value of assets and liabilities[114]. - Recent accounting pronouncements and their expected effects on operations and financial condition are detailed in the Interim Financial Statements[115]. - The company is classified as a smaller reporting company and is not required to provide certain market risk information[116].

Revenue Generation - The company has not generated any revenue in the current fiscal year and does not expect to do so until regulatory approval is obtained for its product candidates[67]. - The company has not generated any revenue from product sales and anticipates continued losses as it develops and seeks regulatory approvals for product candidates[101]. Research and Development Expenses - Research and development expenses for the three months ended October 31, 2023, were $19.1 million, an increase of $1.0 million compared to $18.1 million in the same period of 2022[78]. - Research and development expenses increased by $0.9 million due to the impact of exchange rates in the three months ended October 31, 2023, compared to the same period in the prior fiscal year[79]. - For the six months ended October 31, 2023, total research and development expenses were $38.4 million, an increase of $2.1 million (5.8%) from $36.3 million in the prior year[86]. - Sebetralstat program expenses increased by $3.3 million to $8.3 million due to ongoing Phase 3 KONFIDENT and KONFIDENT-S trials[80]. - KVD824 expenses decreased by $1.8 million to $0.5 million following the termination of the Phase 2 KOMPLETE clinical trial[81]. General and Administrative Expenses - General and administrative expenses increased to $10.7 million for the three months ended October 31, 2023, compared to $7.8 million in the same period of 2022, reflecting an increase of $2.9 million[78]. - General and administrative expenses rose by $2.8 million to $20.4 million, driven by employee-related expenses and commercial strategy costs[84]. Clinical Trials and Regulatory Approvals - The company achieved the target of 252 treated attacks in the KONFIDENT trial and expects topline data readout in early 2024, with an NDA submission anticipated in the first half of 2024[59]. - Sebetralstat has received Fast Track and Orphan Drug designation from the FDA, and Orphan Drug designation in the E.U., indicating regulatory support for its development[62]. - The company is developing an oral disintegrating tablet formulation of sebetralstat, with FDA feedback received on the proposed development program[61]. - The company has treated over 600 attacks across the KONFIDENT and KONFIDENT-S trials to date, supporting the safety database for the planned NDA filing[61]. - The company has not completed the development of any product candidates and is subject to risks related to obtaining regulatory approvals[66]. Financing and Cash Flow - The company entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co. for an aggregate offering price of up to $100 million, but has conducted no sales under this agreement[64]. - Cash flows used in operating activities for the six months ended October 31, 2023, were $46.6 million, compared to $43.3 million in the same period of 2022[97]. - Net cash provided by investing activities was $48.2 million for the six months ended October 31, 2023, primarily from sales and maturities of marketable securities[99]. - The company expects to finance its cash needs through a combination of equity and debt financings, collaborations, and strategic partnerships[102]. Other Income - Other income decreased by $1.5 million due to changes in the U.K. research and development tax credit program, reducing tax credit rates from 130% to 86%[85].

PART I. FINANCIAL INFORMATION This section presents KalVista Pharmaceuticals' unaudited condensed consolidated financial statements, detailing financial position, performance, and cash flows [Item 1. Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents KalVista's unaudited condensed consolidated financial statements, covering balance sheets, operations, equity, and cash flows [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This statement provides a snapshot of the company's assets, liabilities, and equity at specific points in time | Metric | July 31, 2023 (in thousands) | April 30, 2023 (in thousands) | | :-------------------------------- | :--------------------------- | :-------------------------- | | Total current assets | $149,842 | $172,326 | | Total assets | $160,332 | $183,202 | | Total current liabilities | $14,132 | $15,032 | | Total long-term liabilities | $6,865 | $7,145 | | Total stockholders' equity | $139,335 | $161,025 | | Total liabilities and equity | $160,332 | $183,202 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This statement details the company's revenues, expenses, and net loss over specific reporting periods | Metric | Three Months Ended July 31, 2023 (in thousands) | Three Months Ended July 31, 2022 (in thousands) | | :------------------------------------------ | :-------------------------------------------- | :-------------------------------------------- | | Revenue | $— | $— | | Research and development | $19,307 | $18,186 | | General and administrative | $9,786 | $8,130 | | Total operating expenses | $29,093 | $26,316 | | Operating loss | $(29,093) | $(26,316) | | Total other income | $3,776 | $3,274 | | Net loss | $(25,317) | $(23,042) | | Comprehensive (loss) | $(25,148) | $(23,331) | | Net loss per share, basic and diluted | $(0.74) | $(0.94) | | Weighted average common shares outstanding | 34,414,226 | 24,557,615 | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) This statement tracks the changes in the company's equity components over specific reporting periods - For the three months ended July 31, 2023, total stockholders' equity decreased from **$161,025 thousand** to **$139,335 thousand**, primarily due to a net loss of **$25,317 thousand**, partially offset by stock-based compensation expense of **$3,254 thousand** and unrealized holding gains on marketable securities[18](index=18&type=chunk) - For the three months ended July 31, 2022, total stockholders' equity decreased from **$185,093 thousand** to **$164,572 thousand**, driven by a net loss of **$23,042 thousand**, partially offset by stock-based compensation expense of **$2,642 thousand**[20](index=20&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This statement summarizes the cash inflows and outflows from operating, investing, and financing activities | Cash Flow Activity | Three Months Ended July 31, 2023 (in thousands) | Three Months Ended July 31, 2022 (in thousands) | | :--------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | $(26,730) | $(22,742) | | Net cash provided by investing activities | $19,613 | $30,044 | | Net cash provided by financing activities | $204 | $168 | | Effect of exchange rate changes | $84 | $(339) | | Net (decrease) increase in cash | $(6,829) | $7,131 | | Cash and cash equivalents at end of period | $49,409 | $37,863 | [Notes to the Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) These notes provide additional detail and context to the condensed consolidated financial statements [Note 1. The Company](index=8&type=section&id=Note%201.%20The%20Company) KalVista is a clinical-stage pharmaceutical company focused on HAE treatments, with lead candidate sebetralstat in Phase 3 trials - KalVista is a clinical-stage pharmaceutical company developing small molecule protease inhibitors, with an initial focus on hereditary angioedema (HAE)[26](index=26&type=chunk) - Sebetralstat, an oral on-demand therapy for HAE attacks, has completed enrollment for its Phase 3 KONFIDENT trial, with data expected in **Q4 2023** and an NDA submission planned for **H1 2024**[27](index=27&type=chunk) - As of July 31, 2023, the Company had an accumulated deficit of **$368.4 million** and **$123.3 million** in cash, cash equivalents, and marketable securities, anticipating sufficient funding for at least the next twelve months but requiring additional financing for long-term operations[30](index=30&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=9&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) This note details the company's significant accounting policies, including consolidation, GAAP, and fair value measurements - The company operates as a single operating segment and prepares financial statements in accordance with U.S. GAAP for interim financial information[34](index=34&type=chunk)[35](index=35&type=chunk) - ASU 2016-13, effective **May 1, 2023**, regarding credit losses, did not have a material impact on the consolidated financial statements[36](index=36&type=chunk) - Fair value measurements for cash equivalents and marketable securities primarily utilize **Level 1** (quoted market prices) and **Level 2** (observable inputs) hierarchy inputs[42](index=42&type=chunk)[43](index=43&type=chunk) [Note 3. Marketable Securities](index=11&type=section&id=Note%203.%20Marketable%20Securities) This note describes the company's investment policy for marketable securities, focusing on safety, liquidity, and classification - The company's investment policy focuses on safety, preservation of funds, and liquidity, investing in high-credit-quality debt securities[44](index=44&type=chunk) - All debt securities are classified as available-for-sale, with unrealized gains and losses recognized in accumulated comprehensive loss[45](index=45&type=chunk) | Type of Security | Amortized Cost (July 31, 2023, in thousands) | Estimated Fair Value (July 31, 2023, in thousands) | | :------------------------------- | :------------------------------------------- | :----------------------------------------------- | | Corporate debt securities | $58,307 | $58,513 | | U.S. Government agency securities | $15,094 | $15,335 | | Total | $73,401 | $73,848 | | Maturity | July 31, 2023 (in thousands) | | :-------------------------------- | :--------------------------- | | Maturing in one year or less | $50,347 | | Maturing after one year through two years | $12,188 | | Maturing after two years through four years | $11,313 | | Total | $73,848 | [Note 4. Accrued Expenses](index=12&type=section&id=Note%204.%20Accrued%20Expenses) This note provides a breakdown of the company's accrued expenses by category at specific dates | Accrued Expense Category | July 31, 2023 (in thousands) | April 30, 2023 (in thousands) | | :----------------------- | :--------------------------- | :-------------------------- | | Accrued compensation | $2,501 | $4,207 | | Accrued research expense | $3,925 | $3,817 | | Accrued professional fees | $1,376 | $906 | | Other accrued expenses | $148 | $198 | | Total | $7,950 | $9,128 | [Note 5. Prepaid Expenses and Other Current Assets](index=12&type=section&id=Note%205.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) This note details the company's prepaid expenses and other current assets, categorized by type | Prepaid Expense Category | July 31, 2023 (in thousands) | April 30, 2023 (in thousands) | | :----------------------- | :--------------------------- | :-------------------------- | | Prepaid clinical expenses | $3,175 | $1,724 | | Other prepaid expenses | $2,840 | $2,583 | | Interest and other receivables | $469 | $654 | | VAT receivable | $1,044 | $1,422 | | Total | $7,528 | $6,383 | [Note 6. Commitments and Contingencies](index=12&type=section&id=Note%206.%20Commitments%20and%20Contingencies) This note outlines the company's contractual obligations, indemnification agreements, and contingent liabilities - Contractual obligations for preclinical studies and clinical trials totaled **$26.2 million** at July 31, 2023, with cancellation provisions[51](index=51&type=chunk) - The company has indemnification obligations but has not paid any claims or recorded associated charges to date[52](index=52&type=chunk) - No contingent liabilities required accrual as of July 31, 2023[53](index=53&type=chunk) [Note 7. Leases](index=13&type=section&id=Note%207.%20Leases) This note details the company's operating lease agreements for office and laboratory spaces and associated expenses - The company has lease agreements for headquarters in Cambridge, MA (through **Sept 2028**), office/lab space in Porton Down, UK (through **April 2028**), and office space in Salt Lake City, UT (through **Feb 2032**)[54](index=54&type=chunk) - Total rent expense was approximately **$0.5 million** for both the three months ended July 31, 2023, and 2022[55](index=55&type=chunk) | Years ending April 30, | Operating Leases (in thousands) | | :----------------------- | :------------------------------ | | 2024 | $1,308 | | 2025 | $1,777 | | 2026 | $1,814 | | 2027 | $1,853 | | 2028 | $1,848 | | Thereafter | $1,537 | | Total minimum lease payments | $10,137 | | Present value of minimum payments | $7,987 | [Note 8. Subsequent Event](index=13&type=section&id=Note%208.%20Subsequent%20Event) This note reports a new one-year office lease signed in August 2023 for space in Zug, Switzerland - In **August 2023**, the Company signed a new one-year lease for office space in Zug, Switzerland, with monthly payments of approximately **$10,000**, commencing in **September 2023**[57](index=57&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=14&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses KalVista's financial condition, operational results, and strategic focus as a clinical-stage HAE developer [Management Overview](index=14&type=section&id=Management%20Overview) KalVista is a clinical-stage pharmaceutical company focused on HAE treatments, with sebetralstat in Phase 3 and a preclinical program - KalVista is a clinical-stage pharmaceutical company developing small molecule protease inhibitors, primarily for hereditary angioedema (HAE)[59](index=59&type=chunk) - The Phase 3 KONFIDENT clinical trial for sebetralstat, an oral on-demand HAE therapy, achieved its enrollment target of **114 patients** in **July 2023**, with data expected in **Q4 2023** and an NDA submission anticipated in **H1 2024**[61](index=61&type=chunk) - The company is also developing an oral Factor XIIa inhibitor program for HAE and other indications, with multiple compounds in IND-enabling studies[65](index=65&type=chunk) - In **December 2022**, KalVista completed a registered direct offering, raising approximately **$57.7 million** in net proceeds from the sale of common stock and pre-funded warrants[67](index=67&type=chunk) [Financial Overview](index=15&type=section&id=Financial%20Overview) The company has no product sales revenue, expects substantial R&D expenses, and anticipates continued net losses - The company has not generated any product sales revenue and does not expect to until regulatory approval and commercialization of its product candidates[69](index=69&type=chunk) - Research and development expenses are expensed as incurred and are expected to remain substantial and increase as product candidates progress through clinical development[70](index=70&type=chunk)[72](index=72&type=chunk) - Other income comprises interest income, UK R&D tax credits, and foreign currency exchange gains/losses[76](index=76&type=chunk) [Results of Operations](index=17&type=section&id=Results%20of%20Operations) The company reported no revenue, an increased net loss, and higher operating expenses for the three months ended July 31, 2023 | Metric | Three Months Ended July 31, 2023 (in thousands) | Three Months Ended July 31, 2022 (in thousands) | Increase (decrease) (in thousands) | | :---------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :--------------------------------- | | Revenue | $— | $— | $— | | Research and development expenses | $19,307 | $18,186 | $1,121 | | General and administrative expenses | $9,786 | $8,130 | $1,656 | | Interest, exchange rate gain and other income | $3,776 | $3,274 | $502 | - Research and development expenses increased by **$1.1 million**, primarily due to a **$3.4 million** increase in sebetralstat spending and a **$1.1 million** increase in personnel costs, offset by a **$2.7 million** decrease in KVD824 spending[80](index=80&type=chunk)[81](index=81&type=chunk) - General and administrative expenses increased by **$1.7 million**, mainly due to a **$1.3 million** increase in employee-related expenses and a **$0.4 million** increase in professional fees[85](index=85&type=chunk) - Other income increased by **$0.5 million**, driven by a **$1.0 million** increase in currency exchange rate gains and a **$0.7 million** increase in interest income, partially offset by a **$1.5 million** decrease in R&D tax credits[86](index=86&type=chunk) [Liquidity and Capital Resources](index=18&type=section&id=Liquidity%20and%20Capital%20Resources) The company funds operations through equity offerings, anticipates sufficient liquidity for 12 months, and plans future financing - The company has funded operations primarily through the issuance of capital stock and pre-funded warrants and anticipates sufficient funding for at least the next twelve months[87](index=87&type=chunk)[94](index=94&type=chunk) - Future cash needs will be financed through equity offerings, debt financings, collaborations, strategic partnerships, and licensing arrangements, which may lead to stockholder dilution or restrictive covenants[95](index=95&type=chunk) | Cash Flow Activity | Three Months Ended July 31, 2023 (in thousands) | Three Months Ended July 31, 2022 (in thousands) | | :--------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | $(26,730) | $(22,742) | | Net cash provided by investing activities | $19,613 | $30,044 | | Net cash provided by financing activities | $204 | $168 | | Net increase (decrease) in cash | $(6,829) | $7,131 | [Contractual Obligations and Commitments](index=19&type=section&id=Contractual%20Obligations%20and%20Commitments) This section outlines the company's cancelable contractual agreements and operating lease commitments - The company has cancelable contractual agreements with CROs and vendors for clinical trials and services[96](index=96&type=chunk) - KalVista is party to several operating leases for office and laboratory space as of July 31, 2023[96](index=96&type=chunk) [Off-Balance Sheet Arrangements](index=19&type=section&id=Off-Balance%20Sheet%20Arrangements) As of July 31, 2023, the company had no off-balance sheet arrangements as defined by SEC regulations - As of July 31, 2023, the company was not a party to any off-balance sheet arrangements[97](index=97&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=19&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) This section highlights critical accounting policies and estimates used in preparing financial statements under U.S. GAAP - Financial statements require estimates and assumptions affecting reported amounts, based on historical experience, known trends, and other factors[98](index=98&type=chunk) - Critical accounting policies and estimates are discussed in Note 2 of the interim financial statements and the Annual Report on Form 10-K[98](index=98&type=chunk) [Recently Issued Accounting Pronouncements](index=20&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) Details on recently issued accounting pronouncements and their potential impact are provided in Note 2 - Details on recently issued accounting pronouncements are provided in Note 2 of the Interim Financial Statements[99](index=99&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=20&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, KalVista is exempt from providing quantitative and qualitative market risk disclosures - KalVista is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[100](index=100&type=chunk) [Item 4. Controls and Procedures](index=20&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes in internal control - Management concluded that disclosure controls and procedures were effective as of July 31, 2023[101](index=101&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended July 31, 2023[102](index=102&type=chunk) PART II. OTHER INFORMATION This section covers other information not included in financial statements, such as legal proceedings and risk factors [Item 1. Legal Proceedings](index=21&type=section&id=Item%201.%20Legal%20Proceedings) The company is not aware of any legal proceedings expected to materially affect its business or financial condition - The company is not aware of any legal proceedings or claims that would have a material adverse effect on its business[105](index=105&type=chunk) [Item 1A. Risk Factors](index=21&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors from the Annual Report on Form 10-K were identified for this period - No material changes to the risk factors described in the Annual Report on Form 10-K for the fiscal year ended April 30, 2023[106](index=106&type=chunk) - Investors should consider factors discussed in the Annual Report on Form 10-K and other reports, as additional unknown risks may also have a material adverse effect[107](index=107&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=21&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported for the current period - Not applicable for sales of unregistered securities[108](index=108&type=chunk) - No use of proceeds to report[109](index=109&type=chunk) - Not applicable for issuer purchases of equity securities[110](index=110&type=chunk) [Item 3. Defaults Upon Senior Securities](index=21&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company for the current reporting period - Not applicable[111](index=111&type=chunk) [Item 4. Mine Safety Disclosures](index=21&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company for the current reporting period - Not applicable[112](index=112&type=chunk) [Item 5. Other Information](index=21&type=section&id=Item%205.%20Other%20Information) This item is not applicable to the company for the current reporting period - Not applicable[113](index=113&type=chunk) [Item 6. Exhibits](index=22&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including officer certifications and Inline XBRL documents - Exhibits include certifications from the Principal Executive Officer and Principal Financial Officer (Exhibits **31.1**, **31.2**, **32.1**) and Inline XBRL documents (Exhibits **101.INS**, **101.SCH**, **101.CAL**, **101.DEF**, **101.LAB**, **101.PRE**, **104**)[115](index=115&type=chunk) Signatures This section contains the official signatures for the report, confirming its submission and accuracy [Signatures](index=23&type=section&id=Signatures) The report was signed on September 7, 2023, by the Chief Executive Officer and Chief Financial Officer - The report was signed on **September 7, 2023**, by T. Andrew Crockett (CEO) and Benjamin L. Palleiko (President, CBO, CFO)[120](index=120&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Exact name of Registrant as specified in its Charter) (State or other jurisdiction of incorporation or organization) 55 Cambridge Parkway Suite 901 East Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended April 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commissio ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q (Mark One) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended January 31, 2023 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from to . Commission File No. 001-36830 KALVISTA PHARMACEUTICALS, INC. WASHINGTON, DC 20549 (Exact name of registrant as specified in its charter) Delaware 20-0915291 (State or other jur ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION KALVISTA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) WASHINGTON, DC 20549 FORM 10-Q (Mark One) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended October 31, 2022 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from to . Commission File No. 001-36830 Delaware 20-0915291 (State or other jur ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended July 31, 2022 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from to . Commission File No. 001-36830 KALVISTA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 20-0915291 (State or other jurisd ...