Full Press Release Details
KalVista Pharmaceuticals Reports Fiscal Third Quarter Results
- Oral Hereditary Angioedema Franchise Phase 2 Clinical Trials on Track -
Cambridge, MA and Salisbury, England, March 10, 2020 - 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 third quarter ended January 31, 2020.
"Our work to bring multiple best-in-class oral therapies to patients with hereditary angioedema is advancing well," said Andrew Crockett, Chief Executive Officer of KalVista. "First, we look forward to delivering data in the second quarter of this year from our Phase 2 clinical trial with KVD900, our on-demand therapy for HAE attacks. We believe KVD900 has the potential to offer patients an attractive option for control of their disease through a fast-acting tablet that can be taken at the earliest stages of an incipient attack. Second, we continue to make progress in our optimization of KVD824 as a potential oral prophylactic treatment. We still plan to initiate a Phase 2 trial of KVD824 for prophylaxis of HAE attacks in the second half of the year."
Third Quarter and Recent Business Highlights:
Fiscal Third Quarter Financial Results:
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. The initial focus is on inhibitors of plasma kallikrein, which is an important component of the body's inflammatory response and which, in excess, can lead to increased vascular permeability, edema and inflammation. KalVista has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema (HAE) and diabetic macular edema (DME). The Company has created a structurally diverse portfolio of oral plasma kallikrein inhibitors and is advancing multiple drug candidates for HAE as well as DME. KalVista has selected KVD900 as its program to be advanced as an on-demand therapy for acute HAE attacks and is conducting a Phase 2 proof-of-concept study in HAE patients with data expected in the second quarter of 2020. KVD824 is in development for prophylactic treatment of HAE and is expected to enter a Phase 2 clinical trial in the second half of 2020. In DME, an intravitreally administered plasma kallikrein inhibitor known as KVD001, completed a Phase 2 clinical trial in 2019.
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 that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, available funding, our cash runway, potential future clinical trial timing and results. Further information on potential risk factors that could affect our business and its financial results are detailed in the annual report on Form 10-K filed on July 16, 2019, the quarterly report on Form 10-Q filed on March 10, 2020, and other reports as filed 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) | |||||||
| January 31, | April 30, | ||||||
| 2020 | 2019 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 18,615 | $ | 32,006 | |||
| Marketable securities | 61,955 | 68,805 | |||||
| Research and development tax credit receivable | 14,803 | 11,315 | |||||
| Prepaid expenses and other current assets | 3,632 | 3,420 | |||||
| Total current assets | 99,005 | 115,546 | |||||
| Right of use assets | 1,497 | - | |||||
| Property and equipment, net | 2,260 | 2,413 | |||||
| Other assets | 173 | 173 | |||||
| Total assets | $ | 102,935 | $ | 118,132 | |||
| Liabilities and Stockholders' Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 2,951 | $ | 2,860 | |||
| Accrued expenses | 4,876 | 5,647 | |||||
| Deferred revenue - current portion | 1,343 | 9,545 | |||||
| Lease liability - current portion | 592 | - | |||||
| Total current liabilities | 9,762 | 18,052 | |||||
| Long-term liabilities: | |||||||
| Deferred revenue - net of current portion | 2,500 | 3,342 | |||||
| Lease liability - net of current portion | 926 | - | |||||
| Total long-term liabilities | 3,426 | 3,342 | |||||
| Stockholders' equity: | |||||||
| Common stock, $0.001 par value | 18 | 17 | |||||
| Additional paid-in capital | 206,119 | 191,123 | |||||
| Accumulated deficit | (115,008 | ) | (92,476 | ) | |||
| Accumulated other comprehensive loss | (1,382 | ) | (1,926 | ) | |||
| Total stockholders' equity | 89,747 | 96,738 | |||||
| Total liabilities and stockholders' equity | $ | 102,935 | $ | 118,132 |
| 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, | ||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||
| Revenue | $ | 1,577 | $ | 3,890 | $ | 8,866 | $ | 13,201 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 11,233 | 7,650 | 30,709 | 23,882 | |||||||||||
| General and administrative | 3,068 | 2,900 | 9,733 | 7,879 | |||||||||||
| Total operating expenses | 14,301 | 10,550 | 40,442 | 31,761 | |||||||||||
| Operating loss | (12,724 | ) | (6,660 | ) | (31,576 | ) | (18,560 | ) | |||||||
| Other income: | |||||||||||||||
| Interest income | 372 | 723 | 1,467 | 1,016 | |||||||||||
| Foreign currency exchange gain | 138 | 248 | 245 | 83 | |||||||||||
| Other income | 2,923 | 1,733 | 7,332 | 5,171 | |||||||||||
| Total other income | 3,433 | 2,704 | 9,044 | 6,270 | |||||||||||
| Net loss | $ | (9,291 | ) | $ | (3,956 | ) | $ | (22,532 | ) | $ | (12,290 | ) | |||
| Net loss per share to common stockholders, basic and diluted | $ | (0.52 | ) | $ | (0.23 | ) | $ | (1.27 | ) | $ | (0.85 | ) | |||
| Weighted average common shares outstanding, basic and diluted | 17,838,872 | 17,231,449 | 17,717,057 | 14,379,872 |
| KalVista Pharmaceuticals Inc. | |||||||
| Condensed Consolidated Statements of Cash Flows | |||||||
| (in thousands, unaudited) | |||||||
| Nine Months Ended | |||||||
| January 31, | |||||||
| 2020 | 2019 | ||||||
| Cash Flows from Operating Activities | |||||||
| Net loss | $ | (22,532 | ) | $ | (12,290 | ) | |
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
| Depreciation and amortization | 382 | 256 | |||||
| Stock-based compensation expense | 3,358 | 2,120 | |||||
| Realized (gain) from available for sale securities | (229 | ) | - | ||||
| Amortization of right of use assets | 418 | - | |||||
| Amortization of discount/premium on available for sale securities | 136 | - | |||||
| Foreign currency exchange gain | (224 | ) | (20 | ) | |||
| Changes in operating assets and liabilities: | |||||||
| Research and development tax credit receivable | (3,405 | ) | (2,409 | ) | |||
| Prepaid expenses and other current assets | (187 | ) | (2,475 | ) | |||
| Accounts payable | 133 | 1,748 | |||||
| Accrued expenses | (766 | ) | 417 | ||||
| Lease obligations | (416 | ) | - | ||||
| Deferred revenue | (8,866 | ) | (13,201 | ) | |||
| Net cash used in operating activities | (32,198 | ) | (25,854 | ) | |||
| Cash Flows from Investing Activities | |||||||
| Acquisition of property and equipment | (212 | ) | (806 | ) | |||
| Purchases of available for sale securities | (45,114 | ) | (55,419 | ) | |||
| Sales and maturities of available for sale securities | 52,052 | 850 | |||||
| Net cash provided by (used in) investing activities | 6,726 | (55,375 | ) | ||||
| Cash Flows from Financing Activities | |||||||
| Capital lease principal payments | (53 | ) | (155 | ) | |||
| Issuance of common stock from equity incentive plans | 214 | 132 | |||||
| Issuance of common stock, net of offering expenses | 11,422 | 87,811 | |||||
| Net cash provided by financing activities | 11,583 | 87,788 | |||||
| Effect of exchange rate changes on cash and cash equivalents | 498 | (1,269 | ) | ||||
| Net (decrease) increase in cash and cash equivalents | (13,391 | ) | 5,290 | ||||
| Cash and cash equivalents at beginning of period | 32,006 | 51,055 | |||||
| Cash and cash equivalents at end of period | $ | 18,615 | $ | 56,345 |
KalVista Pharmaceuticals, Inc.
Senior Director, Corporate Communications & Investor Relations