KalVista Pharmaceuticals Reports Third Fiscal Quarter Results and Provides Operational Update - March 11, 2024

2024-03-11

临床3期财报高管变更临床结果

Sebetralstat Phase 3 KONFIDENT clinical trial met all endpoints and demonstrated a favorable safety pro first oral on-demand therapy for hereditary angioedema CEO transition supports ongoing evolution into commercial company CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors protease inhibitors, today provided an operational update and released financial results for the third fiscal quarter ended January 31, 2024. “This has been an exciting and busy period for KalVista, as we achieved key milestones with the release of our phase 3 KONFIDENT data and the completion of a substantial financing,” said Ben Palleiko, Chief Executive Officer of KalVista. “We remain on track to NDA with the U.S. Food and Drug Administration in the first half of this year, and we look forward to presenting further phase 3 data for sebetralstat at upcoming patient and medical meetings. We also continue to grow the commercial organization to enable us to deliver on the promise of providing the first oral, on-demand treatment option to the HAE community.” Third Fiscal Quarter and Recent Business Highlights: In February, the Company announced positive topline data from the Phase 3 KONFIDENT clinical trial evaluating the safety and efficacy of sebetralstat as the potential first oral, on-demand therapy for hereditary angioedema (HAE). KONFIDENT was the largest and most representative trial ever conducted in HAE, enrolling a total of 136 patients from 66 clinical sites across 20 countries. Eligible participants included adolescents, patients using long-term prophylaxis, and the trial evaluated all attack severities and locations. The clinical trial met all primary and key secondary endpoints across both the 300 and 600 mg doses and demonstrated a safety pro to placebo. Also in February, KalVista closed an underwritten offering to sell an aggregate of 7,016,312 shares of common stock at price of $15.25 per share and pre-funded warrants to purchase up to 3,483,688 shares of common stock at a price of $15.249 per pre-funded warrant. The net proceeds from the offering were approximately $150.1 million and are expected to provide funding into 2026. The Company announced that Benjamin L. Palleiko, the Company’s prior President, CBO and CFO, was appointed as Chief Executive Officer and a director of the Company. This appointment is the result of a planned transition as KalVista prepares to become a commercial entity following the success of the KONFIDENT Phase 3 trial for its program sebetralstat. The UK Medicines and Healthcare products Regulatory Agency (MHRA) awarded the Innovation Passport for sebetralstat, providing entry to the UK Innovative Licensing and Access Pathway (ILAP), which aims to accelerate time to market and facilitate patient access to innovative medicines. Presented additional Phase 3 KONFIDENT data as well as data on unmet need in HAE from a patient perspective at the 2024 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) in Washington, D.C. Announced publication of the first report of a potent and specific Factor XIIa inhibitor Factor XIIa inhibitor with high oral availability in a peer-reviewed journal. The Frontiers in Pharmacology article describes the pharmacology of a representative compound from KalVista’s portfolio of structurally diverse, oral Factor XII inhibitors. Third Fiscal Quarter Financial Results: Revenue: No revenue was recognized for the three months ended January 31, 2024, or January 31, 2023. R&D Expenses: Research and development expenses were $22.5 million for the three months ended January 31, 2024, compared to $20.1 million for the same period in the prior fiscal year. The increase in R&D expenses during the quarter primarily reflects the ongoing Phase 3 KONFIDENT and KONFIDENT-S trials. G&A Expenses: General and administrative expenses were $10.6 million for the three months ended January 31, 2024, compared to $6.9 million for the same period in the prior fiscal year. The increase in G&A expenses was primarily due to increases in employee-related expenses and commercial planning expenses. Net Loss: Net loss was $29.0 million, or $(0.84) per weighted average basic and diluted share, for the three months ended January 31, 2024, compared to net loss of $21.3 million, or $(0.75) per weighted average basic and diluted share for the same period in the prior fiscal year. The increase in net loss primarily resulted from the increase in operating expenses, primarily research and development. Cash Position: Cash, cash equivalents and marketable securities were $75.6 million as of January 31, 2024, compared to $149.4 million as of April 30, 2023. The decrease in the net cash and marketable securities position was due to cash consumption from operating expenses. About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors protease inhibitors for diseases with significant unmet need. KalVista disclosed positive phase 3 data for the KONFIDENT trial for its oral, on-demand therapy sebetralstat in February 2024. The Company anticipates submitting a new drug application to the U.S. Food and Drug Administration (FDA) for sebetralstat in the first half of 2024 and expects to approval in Europe and Japan later in 2024. In addition, KalVista’s oral Factor XIIa inhibitor Factor XIIa inhibitor program represents a new generation of therapies that may further improve the treatment for people living with HAE and other diseases. For more information about KalVista, please visit . Forward-Looking Statements This press release contains "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 references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates, our ability to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2023, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. KalVista Pharmaceuticals Inc. Condensed Consolidated Balance Sheets (in thousands, except share and per share amounts) (Unaudited) January 31, April 30, 2024 2023 Assets Current assets: Cash and cash equivalents $ 23,056 $ 56,238 Marketable securities 52,530 93,137 Research and development tax credit receivable 23,011 16,568 Prepaid expenses and other current assets 5,506 6,383 Total current assets 104,103 172,326 Property and equipment, net 2,423 2,948 Right of use assets 7,045 7,822 Other assets 397 106 Total assets $ 113,968 $ 183,202 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 3,101 $ 4,817 Accrued expenses 14,840 9,128 Lease liability - current portion 1,187 1,087 Total current liabilities 19,128 15,032 Long-term liabilities: Lease liability - net of current portion 6,257 7,145 Total long-term liabilities 6,257 7,145 Stockholders’ equity: Common stock, $0.001 par value 34 34 Additional paid-in capital 516,920 507,133 Accumulated deficit (425,077 ) (343,082 ) Accumulated other comprehensive loss (3,294 ) (3,060 ) Total stockholders’ equity 88,583 161,025 Total liabilities and stockholders' equity $ 113,968 $ 183,202 KalVista Pharmaceuticals Inc. Condensed Consolidated Statement of Operations (in thousands, except share and per share amounts) (Unaudited) Three Months Ended Nine Months Ended January 31, January 31, 2024 2023 2024 2023 Revenue $ — $ — $ — $ — Operating expenses: Research and development 22,523 20,063 60,919 56,325 General and administrative 10,628 6,882 31,071 22,818 Total operating expenses 33,151 26,945 91,990 79,143 Operating loss (33,151 ) (26,945 ) (91,990 ) (79,143 ) Other income: Interest income 684 732 2,383 1,424 Foreign currency exchange rate gain (loss) 1,120 597 277 (237 ) Other income 2,319 4,313 7,335 11,354 Total other income 4,123 5,642 9,995 12,541 Net loss $ (29,028 ) $ (21,303 ) $ (81,995 ) $ (66,602 ) Net loss per share, basic and diluted $ (0.84 ) $ (0.75 ) $ (2.37 ) $ (2.58 ) Weighted average common shares outstanding, basic and diluted 34,723,379 28,278,453 34,567,853 25,810,369 KalVista Pharmaceuticals Inc. Condensed Consolidated Statements of Cash Flows (in thousands, unaudited) Nine Months Ended January 31, 2024 2023 Cash flows from operating activities Net loss $ (81,995 ) $ (66,602 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 597 530 Stock-based compensation expense 9,172 7,481 Realized (gain) loss from sale of marketable securities (1,130 ) 84 Non-cash operating lease expense (11 ) 52 Amortization of premium on marketable securities 88 890 Foreign currency exchange loss (gain) 596 (1,339 ) Changes in operating assets and liabilities: Research and development tax credit receivable (6,215 ) 2,049 Prepaid expenses and other current assets 906 4,440 Accounts payable (1,778 ) (1,911 ) Accrued expenses 5,644 1,701 Net cash used in operating activities (74,126 ) (52,625 ) Cash flows from investing activities Purchases of marketable securities (47,687 ) (63,757 ) Sales and maturities of marketable securities 89,475 112,509 Acquisition of property and equipment (27 ) (1,127 ) Website development costs (294 ) — Net cash provided by investing activities 41,467 47,625 Cash flows from financing activities Issuance of common stock from equity incentive plans 616 482 Issuance of common stock, net of offering expenses of $0.3 million — 56,582 Issuance of pre-funded warrants, net of offering expenses — 1,085 Net cash provided by financing activities 616 58,149 Effect of exchange rate changes on cash and cash equivalents (1,139 ) 1,168 Net (decrease) increase in cash and cash equivalents (33,182 ) 54,317 Cash and cash equivalents at beginning of period 56,238 30,732 Cash and cash equivalents at end of period $ 23,056 $ 85,049 View source version on businesswire.com: Contacts KalVista Pharmaceuticals, Inc. Jarrod Aldom Vice President, Corporate Communications (201) 705-0254 jarrod.aldom@kalvista.com Ryan Baker Head, Investor Relations (617) 771-5001 ryan.baker@kalvista.com Source: KalVista Pharmaceuticals, Inc. View this news release online at: