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 ...

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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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, 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 Number 001-36830 KalVista Pharmaceuticals, Inc. (Exact name of Registrant as specified in its Charter) Delaware 20-0915291 (State or other jurisdic ...

K KalVista Pharmaceuticals Corporate Overview June 2022 Forward-Looking Statements This presentation and the accompanying oral presentation contain "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future, "likely," "may," "should," "will" and similar re ...