Full Press Release Details
KalVista Pharmaceuticals Provides Operational Update and Fiscal Year Financial Results
- FDA End-of-Phase 2 Meeting on KVD900 Oral HAE Phase 3 Program Scheduled for Late Q3 2021 -
- FDA Response Submission for KVD824 Phase 2 Clinical Hold Expected Q3 2021 -
Cambridge, MA and Salisbury, England, July 13, 2021 - KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today provided an operational update and released financial results for the fiscal year ended April 30, 2021.
"This past fiscal year we made great strides in providing data to support the development of the candidates in our oral hereditary angioedema franchise," said Andrew Crockett, Chief Executive Officer of KalVista. "Now we are at an important inflection point as we work with regulatory agencies to both finalize the Phase 3 program for KVD900 and begin the Phase 2 clinical trial of KVD824. With our financing earlier this year we are well-capitalized to focus on execution of these activities, and we look forward to providing additional details on the trials later this year as they begin."
Fiscal 2021 and Recent Business Highlights:
Fourth Quarter and Full Year Financial Results:
On July 11, 2021, the Board of Directors adopted the KalVista Pharmaceuticals, Inc. 2021 Inducement Equity Incentive Plan (the "Plan"). The Plan reserves 350,000 shares of common stock to be used exclusively for grants of awards to individuals that were not previously employees or directors of KalVista, as an inducement material to the individual's entry into employment with KalVista within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. The Plan was approved by Board of Directors without stockholder approval pursuant to Rule 5635(c)(4), and the terms and conditions of the Plan are substantially similar to KalVista's stockholder-approved 2017 Equity Incentive Plan, as amended.
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet need. KalVista has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema (HAE) and diabetic macular edema (DME). KalVista is developing KVD900 as an oral on-demand therapy for acute HAE attacks, which completed a Phase 2 efficacy trial in February 2021, demonstrating statistical and clinical significance across all endpoints. KVD824 is in development for prophylactic treatment of HAE. In addition, KalVista's oral Factor XIIa inhibitor program represents a new generation of therapies that may further improve the treatment of HAE for patients. In DME, an intravitreally administered plasma kallikrein inhibitor, called KVD001, has completed a Phase 2 clinical trial.
For more information, please visit www.kalvista.com.
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, including the potential impact of COVID-19, that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence or complete clinical studies and to obtain regulatory approvals for KVD900, KVD824 and other candidates in development, our ability to resolve a clinical hold with regards to KVD824, the ability of KVD900, KVD824 and other candidates in development to treat HAE or DME, the future progress and potential success of our oral Factor XIIa program, and the sufficiency of our cash, cash equivalents and investments to fund our operations. Further information on potential risk factors that could affect our business and financial results are detailed in our annual report on Form 10-K filed on July 1, 2020, our quarterly reports on Form 10-Q, and other filings 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.
Senior Director, Corporate Communications & Investor Relations
| KalVista Pharmaceuticals Inc. | |||||||
| Condensed Consolidated Balance Sheets | |||||||
| (in thousands, except share and per share amounts) | |||||||
| (Unaudited) | |||||||
| April 30, | April 30, | ||||||
| 2021 | 2020 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 50,592 | $ | 15,789 | |||
| Marketable securities | 198,337 | 51,925 | |||||
| Research and development tax credit receivable | 10,418 | 16,527 | |||||
| Prepaid expenses and other current assets | 4,917 | 4,455 | |||||
| Total current assets | 264,264 | 88,696 | |||||
| Property and equipment, net | 1,791 | 2,043 | |||||
| Right of use assets | 5,758 | 1,612 | |||||
| Other assets | 200 | 178 | |||||
| Total assets | $ | 272,013 | $ | 92,529 | |||
| Liabilities and stockholders' equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 1,981 | $ | 1,677 | |||
| Accrued expenses | 6,930 | 5,455 | |||||
| Lease liability - current portion | 863 | 588 | |||||
| Total current liabilities | 9,774 | 7,720 | |||||
| Long-term liabilities: | |||||||
| Lease liability - net of current portion | 5,046 | 1,057 | |||||
| Total long-term liabilities | 5,046 | 1,057 | |||||
| Stockholders' equity: | |||||||
| Common stock, $0.001 par value | 24 | 18 | |||||
| Additional paid-in capital | 426,437 | 207,208 | |||||
| Accumulated deficit | (167,836 | ) | (121,592 | ) | |||
| Accumulated other comprehensive loss | (1,432 | ) | (1,882 | ) | |||
| Total stockholders' equity | 257,193 | 83,752 | |||||
| Total liabilities and stockholders' equity | $ | 272,013 | $ | 92,529 |
| KalVista Pharmaceuticals Inc. | |||||||||||||||
| Condensed Consolidated Statement of Operations | |||||||||||||||
| (in thousands, except share and per share amounts) | |||||||||||||||
| (Unaudited) | |||||||||||||||
| Three Months Ended | Years Ended | ||||||||||||||
| April 30, | April 30, | ||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||
| Revenue | $ | - | $ | 3,824 | $ | - | $ | 12,690 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 11,877 | 9,485 | 41,286 | 40,194 | |||||||||||
| General and administrative | 6,165 | 3,296 | 16,637 | 13,029 | |||||||||||
| Total operating expenses | 18,042 | 12,781 | 57,923 | 53,223 | |||||||||||
| Operating loss | (18,042 | ) | (8,957 | ) | (57,923 | ) | (40,533 | ) | |||||||
| Other income: | |||||||||||||||
| Interest income | 314 | 363 | 903 | 1,830 | |||||||||||
| Foreign currency exchange rate gain (loss) | 132 | (613 | ) | 847 | (367 | ) | |||||||||
| Other income | 2,639 | 2,498 | 9,929 | 9,830 | |||||||||||
| Total other income | 3,085 | 2,248 | 11,679 | 11,293 | |||||||||||
| Loss before income taxes | (14,957 | ) | (6,709 | ) | (46,244 | ) | (29,240 | ) | |||||||
| Income tax (benefit) expense | - | (124 | ) | - | (124 | ) | |||||||||
| Net loss | $ | (14,957 | ) | $ | (6,585 | ) | $ | (46,244 | ) | $ | (29,116 | ) | |||
| Net loss per share, basic and diluted | $ | (0.65 | ) | $ | (0.37 | ) | $ | (2.42 | ) | $ | (1.64 | ) | |||
| Weighted average common shares outstanding, basic and diluted | 23,118,127 | 17,845,599 | 19,094,440 | 17,748,666 |
| KalVista Pharmaceuticals Inc. | |||||||
| Condensed Consolidated Statements of Cash Flows | |||||||
| (in thousands, unaudited) | |||||||
| Years Ended | |||||||
| April 30, | |||||||
| 2021 | 2020 | ||||||
| Cash flows from operating activities | |||||||
| Net loss | $ | (46,244 | ) | $ | (29,116 | ) | |
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
| Depreciation and amortization | 537 | 512 | |||||
| Stock-based compensation expense | 7,118 | 4,448 | |||||
| Realized (gain) from sale of marketable securities | (153 | ) | (300 | ) | |||
| Non-cash operating lease expense | 114 | 13 | |||||
| Amortization of premium on available for sale securities | 685 | 193 | |||||
| Foreign currency exchange (gain) loss | (574 | ) | 74 | ||||
| Changes in operating assets and liabilities: | |||||||
| Research and development tax credit receivable | 7,457 | (5,781 | ) | ||||
| Prepaid expenses and other current assets | (222 | ) | (1,112 | ) | |||
| Other assets | (22 | ) | (5 | ) | |||
| Accounts payable | 150 | (1,004 | ) | ||||
| Accrued expenses | 983 | (48 | ) | ||||
| Deferred revenue | - | (12,690 | ) | ||||
| Net cash used in operating activities | (30,171 | ) | (44,816 | ) | |||
| Cash flows from investing activities | |||||||
| Purchases of available for sale securities | (201,210 | ) | (49,797 | ) | |||
| Sales and maturities of available for sale securities | 53,638 | 66,770 | |||||
| Acquisition of property and equipment | (82 | ) | (220 | ) | |||
| Net cash provided by (used in) investing activities | (147,654 | ) | 16,753 | ||||
| Cash flows from financing activities | |||||||
| Issuance of common stock, net of offering expenses | 210,582 | 11,422 | |||||
| Issuance of common stock from equity incentive plans | 1,535 | 216 | |||||
| Finance lease principal payments | - | (54 | ) | ||||
| Net cash provided by financing activities | 212,117 | 11,584 | |||||
| Effect of exchange rate changes on cash and cash equivalents | 511 | 262 | |||||
| Net increase (decrease) in cash and cash equivalents | 34,803 | (16,217 | ) | ||||
| Cash and cash equivalents, beginning of year | 15,789 | 32,006 | |||||
| Cash and cash equivalents, end of year | $ | 50,592 | $ | 15,789 |