PART I. FINANCIAL INFORMATION Financial Statements (unaudited) For the quarter ended July 31, 2021, the company reported no revenue, a net loss of $16.1 million, and a decrease in total assets to $259.1 million, driven by increased expenses and reduced cash holdings Condensed Consolidated Balance Sheets As of July 31, 2021, total assets decreased to $259.1 million from $272.0 million, primarily due to reduced cash and marketable securities, with total stockholders' equity also decreasing to $244.4 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | July 31, 2021 | April 30, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $48,343 | $50,592 | | Marketable securities | $182,288 | $198,337 | | Total Assets | $259,133 | $272,013 | | Total current liabilities | $8,229 | $9,774 | | Total Liabilities | $14,703 | $14,820 | | Total Stockholders' Equity | $244,430 | $257,193 | Condensed Consolidated Statements of Operations and Comprehensive Loss For the three months ended July 31, 2021, the company reported no revenue and a net loss of $16.1 million, an increase from $10.8 million in the prior year, driven by higher R&D and G&A expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended July 31, 2021 | Three Months Ended July 31, 2020 | | :--- | :--- | :--- | | Revenue | $— | $— | | Research and development | $13,669 | $11,165 | | General and administrative | $5,847 | $3,278 | | Operating loss | ($19,516) | ($14,443) | | Net loss | ($16,109) | ($10,814) | | Net loss per share, basic and diluted | ($0.66) | ($0.61) | Condensed Consolidated Statements of Changes in Stockholders' Equity Total stockholders' equity decreased to $244.4 million by July 31, 2021, primarily due to the $16.1 million net loss, partially offset by stock-based compensation and common stock issuances - The primary driver for the decrease in stockholders' equity during the three months ended July 31, 2021 was the net loss of $16.1 million17 Condensed Consolidated Statements of Cash Flows For the three months ended July 31, 2021, net cash used in operating activities was $17.7 million, leading to a net decrease of $2.2 million in cash and equivalents, ending the period with $48.3 million Summary of Cash Flows (in thousands) | Activity | Three Months Ended July 31, 2021 | Three Months Ended July 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($17,735) | ($3,588) | | Net cash provided by investing activities | $14,881 | $5,513 | | Net cash provided by financing activities | $608 | $46 | | Net (decrease) increase in cash | ($2,249) | $2,225 | | Cash and cash equivalents at end of period | $48,343 | $18,014 | Notes to the Condensed Consolidated Financial Statements The notes detail the company's focus on developing small molecule protease inhibitors for HAE and DME, confirming sufficient funding for the next twelve months and outlining contractual commitments - The company is a clinical-stage pharmaceutical firm focused on small molecule protease inhibitors for hereditary angioedema (HAE) and diabetic macular edema (DME)22 - The company anticipates it has sufficient funding to operate for at least the next twelve months, with $230.6 million in cash, cash equivalents, and marketable securities as of July 31, 202127 - The company has contractual obligations of $29.1 million at July 31, 2021, related to ongoing preclinical studies and clinical trials45 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the clinical development of oral plasma kallikrein inhibitors for HAE and DME, highlighting KVD900's Phase 2 success and KVD824's ongoing trial despite a U.S. clinical hold, while confirming sufficient capital for the next twelve months Management Overview The company focuses on developing oral plasma kallikrein inhibitors for HAE, with KVD900 showing positive Phase 2 results and KVD824's Phase 2 trial progressing outside the U.S. despite an FDA clinical hold - KVD900, an on-demand HAE therapy, met all primary and secondary endpoints in its Phase 2 trial, and the company is preparing for a Phase 3 trial pending FDA feedback5760 - KVD824, a prophylactic HAE therapy, is under an FDA clinical hold in the U.S.; however, the Phase 2 KOMPLETE trial has commenced enrollment in Canada, Australia, New Zealand, and the UK6263 - A new oral Factor XIIa inhibitor program is in lead optimization, with plans to initiate IND-enabling studies in 20216869 Results of Operations For the three months ended July 31, 2021, R&D expenses increased by $2.5 million to $13.7 million, and G&A expenses rose by $2.6 million to $5.8 million, primarily due to preclinical activities and higher compensation Research and Development Expenses by Program (in thousands) | Program | Three Months Ended July 31, 2021 | Three Months Ended July 31, 2020 | | :--- | :--- | :--- | | KVD001 | $32 | $86 | | KVD900 | $4,097 | $4,451 | | KVD824 | $2,380 | $2,288 | | Preclinical activities | $7,160 | $4,340 | | Total | $13,669 | $11,165 | - R&D expenses increased by $2.5 million, mainly due to a $2.8 million rise in spending on preclinical activities84 - General and administrative expenses increased by $2.6 million, primarily from a $1.4 million increase in compensation expense due to higher headcount and stock-based compensation89 Liquidity and Capital Resources The company funds operations primarily through equity issuances, confirming sufficient working capital for the next twelve months, despite using $17.7 million in operating cash for the quarter and no sales under its $100.0 million equity offering agreement - The company anticipates its working capital, primarily cash and marketable securities, will fund operations for at least the next twelve months91 - Net cash used in operating activities was $17.7 million for the three months ended July 31, 2021, compared to $3.6 million in the prior-year period93 - In May 2021, the company entered into a sales agreement to offer and sell up to $100.0 million of its common stock; however, No shares were sold during the three months ended July 31, 20219697 Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, KalVista is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, KalVista is not required to provide quantitative and qualitative disclosures about market risk104 Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective as of July 31, 2021, with no material changes in internal control over financial reporting during the quarter - Based on an evaluation as of July 31, 2021, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective105 - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls106 PART II. OTHER INFORMATION Legal Proceedings The company is not currently aware of any legal proceedings expected to have a material adverse effect on its business, financial condition, or operating results - The company is not currently aware of any legal proceedings that would have a material adverse effect on its business109 Risk Factors No material changes have been made to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended April 30, 2021 - No material changes have been made to the risk factors described in the Annual Report on Form 10-K for the fiscal year ended April 30, 2021110 Unregistered Sales of Equity Securities and Use of Proceeds This section is not applicable to the current report - This item is not applicable112 Exhibits This section lists the exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer and Inline XBRL documents - The report includes certifications from the CEO and CFO pursuant to Sarbanes-Oxley Act Sections 302 and 906, along with XBRL data files117
KalVista Pharmaceuticals(KALV) - 2022 Q1 - Quarterly Report