Full Press Release Details
KalVista Pharmaceuticals Provides Operational Update and Fiscal Year Financial Results
- KVD900 Phase 2 Clinical Trial for Oral Treatment of Hereditary Angioedema (HAE) Data Expected in 2H 2020 -
- Oral HAE Prophylactic Candidate KVD824 Phase 2 Clinical Trial Planned to Commence in 2H 2020 -
- Operations Funded into 2022 -
Cambridge, MA and Salisbury, England, July 1, 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 year ended April 30, 2020.
"We have two oral candidates in clinical trials that have the potential to provide HAE patients with a complete set of options to treat their disease," said Andrew Crockett, Chief Executive Officer of KalVista. "We are pleased with our progress with the formulation work for KVD824 to deliver a twice-daily treatment for prevention of HAE attacks. Subjects have begun dosing with these new formulations to obtain additional pharmacokinetic and pharmacodynamic data, and we look forward to providing these data later this year in advance of starting a Phase 2 clinical trial. Patients also continue to be treated in our Phase 2 clinical trial for KVD900 as an on-demand therapy, and we expect data from that trial in the second half of this year."
Fiscal 2020 and Recent Business Highlights:
Fourth Quarter and Full Year 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 half 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, potential benefits of our product candidates, and the impact of COVID-19. Further information on potential risk factors that could affect our business and its 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, 2020 once filed, and our other reports that we may file 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, | ||||||
| 2020 | 2019 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 15,789 | $ | 32,006 | |||
| Marketable securities | 51,925 | 68,805 | |||||
| Research and development tax credit receivable | 16,527 | 11,315 | |||||
| Prepaid expenses and other current assets | 4,455 | 3,420 | |||||
| Total current assets | 88,696 | 115,546 | |||||
| Property and equipment, net | 2,043 | 2,413 | |||||
| Right of use assets | 1,612 | - | |||||
| Other assets | 178 | 173 | |||||
| Total assets | $ | 92,529 | $ | 118,132 | |||
| Liabilities and stockholders' equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 1,677 | $ | 2,860 | |||
| Accrued expenses | 5,455 | 5,647 | |||||
| Deferred revenue - current portion | - | 9,545 | |||||
| Lease liability - current portion | 588 | - | |||||
| Total current liabilities | 7,720 | 18,052 | |||||
| Long-term liabilities: | |||||||
| Deferred revenue - net of current portion | - | 3,342 | |||||
| Lease liability - net of current portion | 1,057 | - | |||||
| Total long-term liabilities | 1,057 | 3,342 | |||||
| Stockholders' equity: | |||||||
| Common stock, $0.001 par value | 18 | 17 | |||||
| Additional paid-in capital | 207,208 | 191,123 | |||||
| Accumulated deficit | (121,592 | ) | (92,476 | ) | |||
| Accumulated other comprehensive loss | (1,882 | ) | (1,926 | ) | |||
| Total stockholders' equity | 83,752 | 96,738 | |||||
| Total liabilities and stockholders' equity | $ | 92,529 | $ | 118,132 |
| 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, | ||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||
| Revenue | $ | 3,824 | $ | 2,926 | $ | 12,690 | $ | 16,127 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 9,485 | 11,139 | 40,194 | 35,021 | |||||||||||
| General and administrative | 3,296 | 3,047 | 13,029 | 10,926 | |||||||||||
| Total operating expenses | 12,781 | 14,186 | 53,223 | 45,947 | |||||||||||
| Operating loss | (8,957 | ) | (11,260 | ) | (40,533 | ) | (29,820 | ) | |||||||
| Other income: | |||||||||||||||
| Interest income | 363 | 381 | 1,830 | 1,397 | |||||||||||
| Foreign currency exchange rate gain (loss) | (613 | ) | (34 | ) | (367 | ) | 49 | ||||||||
| Other income | 2,498 | 2,511 | 9,830 | 7,682 | |||||||||||
| Total other income | 2,248 | 2,858 | 11,293 | 9,128 | |||||||||||
| Loss before income taxes | (6,709 | ) | (8,402 | ) | (29,240 | ) | (20,692 | ) | |||||||
| Income tax (benefit) expense | (124 | ) | 124 | (124 | ) | 124 | |||||||||
| Net loss | $ | (6,585 | ) | $ | (8,526 | ) | $ | (29,116 | ) | $ | (20,816 | ) | |||
| Net loss per share, basic and diluted | $ | (0.37 | ) | $ | (0.49 | ) | $ | (1.64 | ) | $ | (1.38 | ) | |||
| Weighted average common shares outstanding, basic and diluted | 17,845,599 | 17,253,938 | 17,748,666 | 15,080,863 |
| KalVista Pharmaceuticals Inc. | |||||||
| Condensed Consolidated Statements of Cash Flows | |||||||
| (in thousands, unaudited) | |||||||
| Years Ended | |||||||
| April 30, | |||||||
| 2020 | 2019 | ||||||
| Cash flows from operating activities | |||||||
| Net loss | $ | (29,116 | ) | $ | (20,816 | ) | |
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
| Depreciation and amortization | 512 | 378 | |||||
| Stock-based compensation expense | 4,448 | 2,966 | |||||
| Realized (gain) from sale of marketable securities | (300 | ) | (23 | ) | |||
| Non-cash operating lease expense | 13 | - | |||||
| Amortization of premium on available for sale securities | 193 | - | |||||
| Foreign currency exchange (gain) loss | 74 | (80 | ) | ||||
| Changes in operating assets and liabilities: | |||||||
| Research and development tax credit receivable | (5,781 | ) | (4,883 | ) | |||
| Prepaid expenses and other current assets | (1,112 | ) | (1,979 | ) | |||
| Other assets | (5 | ) | - | ||||
| Accounts payable | (1,004 | ) | 1,534 | ||||
| Accrued expenses | (48 | ) | 2,665 | ||||
| Deferred revenue | (12,690 | ) | (16,127 | ) | |||
| Net cash used in operating activities | (44,816 | ) | (36,365 | ) | |||
| Cash flows from investing activities | |||||||
| Purchases of available for sale securities | (49,797 | ) | (79,889 | ) | |||
| Sales and maturities of available for sale securities | 66,770 | 11,548 | |||||
| Acquisition of property and equipment | (220 | ) | (1,081 | ) | |||
| Net cash provided by (used in) investing activities | 16,753 | (69,422 | ) | ||||
| Cash flows from financing activities | |||||||
| Issuance of common stock, net of offering expenses | 11,422 | 87,910 | |||||
| Issuance of common stock from equity incentive plans | 216 | 242 | |||||
| Finance lease principal payments | (54 | ) | (209 | ) | |||
| Net cash provided by financing activities | 11,584 | 87,943 | |||||
| Effect of exchange rate changes on cash and cash equivalents | 262 | (1,205 | ) | ||||
| Net decrease in cash and cash equivalents | (16,217 | ) | (19,049 | ) | |||
| Cash and cash equivalents, beginning of year | 32,006 | 51,055 | |||||
| Cash and cash equivalents, end of year | $ | 15,789 | $ | 32,006 |
KalVista Pharmaceuticals, Inc.
Senior Director, Corporate Communications & Investor Relations