Clinical Development - The Phase 3 KONFIDENT clinical trial for sebetralstat enrolled 136 patients across 66 sites in 20 countries, meeting all primary and key secondary endpoints with a safety profile similar to placebo [70]. - A New Drug Application (NDA) for sebetralstat was filed with the FDA in June 2024, with a PDUFA notification date set for June 17, 2025 [71]. - The European Medicines Agency (EMA) is currently reviewing the Marketing Authorization Application (MAA) for sebetralstat, which aims for broad availability across 27 EU member states [72]. - The company initiated a pediatric clinical trial for an orally disintegrating tablet formulation of sebetralstat, targeting patients aged 2 to 11 years [76]. Financial Performance - General and administrative expenses increased by $18.5 million to $29.2 million for the three months ended October 31, 2024, primarily due to increases in personnel costs and commercial expenses [98]. - General and administrative expenses increased by $26.4 million to $46.8 million for the six months ended October 31, 2024, primarily due to increases in commercial strategy expenses and personnel costs [104]. - Research and development expenses decreased by $2.5 million to $16.6 million for the three months ended October 31, 2024, compared to $19.1 million in the same period in 2023 [94]. - Research and development expenses increased by $4.8 million to $43.2 million for the six months ended October 31, 2024, compared to $38.4 million in the same period in 2023 [101]. - Net cash used in operating activities was $79.9 million for the six months ended October 31, 2024, compared to $46.6 million in the same period in 2023 [112]. - Net cash provided by investing activities was $85.8 million for the six months ended October 31, 2024, compared to $48.2 million in the same period in 2023 [113]. Funding and Capital Structure - The subsidiary received an upfront payment of $100 million from DRI Healthcare Acquisitions LP in exchange for tiered payments on future worldwide net sales of sebetralstat [80]. - The tiered payment structure includes 5% on annual net sales up to $500 million, 1.1% on sales between $500 million and $750 million, and 0.25% on sales above $750 million [80]. - In November 2024, the company entered into a royalty purchase agreement for $100.0 million in exchange for tiered royalty payments on worldwide net sales of sebetralstat [111]. - The company anticipates sufficient funding to operate for at least the next twelve months based on current capital resources [119]. - The company expects to finance cash needs through equity and debt financings, collaborations, strategic partnerships, and licensing arrangements [120]. - Existing stockholders may face dilution if additional capital is raised through stock or convertible debt securities [120]. - Debt financing may involve increased fixed payment obligations and covenants that could restrict business operations [120]. - The company entered into an underwriting agreement to issue 5,500,000 shares at $10.00 per share, netting approximately $51.3 million [82]. Tax and Regulatory Considerations - The company has incurred net losses historically and has no corporation tax liabilities, benefiting from research and development tax credits in the UK [91]. - Financial statements are prepared in accordance with U.S. GAAP, requiring estimates and assumptions that may affect reported amounts [122]. - Actual results may differ from estimates based on various factors, impacting the carrying value of assets and liabilities [122]. - Recent accounting pronouncements and their expected effects on operations and financial condition are detailed in the Interim Financial Statements [124]. - The company qualifies as a smaller reporting company and is not required to provide certain market risk disclosures [125]. Operational Considerations - The company expects to continue significant investment in research and development activities, particularly for clinical development and manufacturing [87]. - The company is party to several operating leases for office and laboratory space as of October 31, 2024 [121]. - Other income increased by $1.5 million, primarily due to an increase in foreign currency exchange rate gains of $1.4 million [99].

Financial Performance - KalVista Pharmaceuticals reported no revenue for the first fiscal quarter ended July 31, 2024, consistent with the same period in the prior fiscal year[5]. - The net loss for the quarter was $40.4 million, or $(0.87) per share, compared to a net loss of $25.3 million, or $(0.74) per share, in the prior year[6]. - Total operating expenses for the quarter were $44.2 million, compared to $29.1 million in the same period last year[11]. Research and Development - Research and development expenses increased to $26.6 million for the quarter, up from $19.3 million year-over-year, primarily due to the phase 3 KONFIDENT trial and increased personnel costs[5]. - The KONFIDENT-KID pediatric clinical trial has been initiated, enrolling approximately 24 children aged 2 to 11 years across seven countries[3]. Administrative Expenses - General and administrative expenses rose to $17.6 million, compared to $9.8 million in the same quarter last year, driven by higher commercial planning and employee-related expenses[5]. Cash Position - Cash, cash equivalents, and marketable securities decreased to $174.3 million as of July 31, 2024, down from $210.4 million on April 30, 2024, due to cash consumption from operating expenses[6]. Regulatory Developments - The FDA accepted the NDA for sebetralstat with a PDUFA goal date of June 17, 2025, and the EMA validated the MAA submission[2]. - KalVista plans to file for approval in the UK, Japan, and other countries later in 2024, aiming for the first commercial launch of sebetralstat in June 2025[2]. - The company expects to maximize regulatory collaboration across countries through engagement with the Access Consortium[3].

Revenue Generation - 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[55]. - The company has not generated any revenue from product sales and expects to continue incurring losses as it develops and seeks regulatory approvals for product candidates[77]. Research and Development Expenses - Research and development expenses increased by $7.3 million to $26.6 million for the three months ended July 31, 2024, compared to $19.3 million in the same period in the prior fiscal year[65]. - The increase in research and development expenses was driven by $3.3 million in spending on the sebetralstat program, $2.3 million in personnel costs, and $1.9 million in preclinical and other activities[65]. - Research and development expenses totaled $26.6 million for the three months ended July 31, 2024, an increase of $7.3 million compared to $19.3 million in the same period of 2023[66]. - Personnel expenses rose by $2.3 million to $9.1 million, driven by higher headcount in research and development and medical teams[67]. - The increase in research and development tax credit receivable was $1.3 million for the three months ended July 31, 2024[71]. General and Administrative Expenses - General and administrative expenses rose by $7.8 million to $17.6 million for the three months ended July 31, 2024, compared to $9.8 million in the same period in the prior fiscal year[65]. - General and administrative expenses increased by $7.8 million, primarily due to a $4.5 million rise in commercial expenses and a $2.5 million increase in employee-related expenses[68]. Clinical Trials and Regulatory Approvals - The company filed a New Drug Application (NDA) with the FDA in June 2024 for sebetralstat, with a PDUFA notification date of June 17, 2025[47]. - The KONFIDENT clinical trial for sebetralstat enrolled 136 patients across 66 clinical sites in 20 countries, meeting all primary and key secondary endpoints[46]. - The European Medicines Agency (EMA) is currently reviewing the Marketing Authorization Application (MAA) for sebetralstat, with plans to file for approval in the U.K., Japan, and other countries later in 2024[48]. - The company initiated a pediatric clinical trial (KONFIDENT-KID) for an orally disintegrating tablet formulation of sebetralstat, targeting patients aged 2 to 11 years old[51]. - The company has received Fast Track and Orphan Drug designations from the FDA for sebetralstat, indicating its potential significance in treating HAE[52]. Financial Activities - The company raised approximately $150.1 million from a stock offering in February 2024, selling 7,016,312 shares at $15.25 per share[53]. - Net cash used in operating activities was $40.2 million for the three months ended July 31, 2024, compared to $26.7 million for the same period in 2023[71]. - Net cash provided by investing activities was $37.2 million for the three months ended July 31, 2024, compared to $19.6 million in the prior year[72]. - The company anticipates sufficient funding to operate for at least the next twelve months based on current capital resources[69]. - In February 2024, the company raised approximately $150.1 million from the sale of 7,016,312 shares at $15.25 per share[70]. - The company filed a Registration Statement in July 2024 to offer securities with an aggregate public offering price of up to $300 million[70].

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].

FORM 10-Q (Mark One) UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended July 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. (Exact name of registrant as specified in its charter) Delaware 20-0915291 (State or other jurisd ...

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 ...