Full Press Release Details
KalVista Pharmaceuticals Provides Operational Update and Fiscal Year Financial Results
- KVD900 Enrolling Phase 2 Clinical Trial for Oral Treatment of Hereditary Angioedema (HAE) with Data Expected in Late 2019 -
- Enrollment Complete in KVD001 Phase 2 Clinical Trial for Patients with Diabetic Macular Edema (DME) with Data Expected in H2 2019 -
- Operations Funded into 2021 -
Cambridge, MA and Salisbury, England, July 15, 2019 - 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, 2019.
"This fiscal year has been busy as we prepare for data in two Phase 2 clinical trials before the end of 2019," said Andrew Crockett, Chief Executive Officer of KalVista. "We believe the use of KVD900 has the potential to be a compelling option for patients in search of an oral on-demand therapy for HAE because of its rapid and high exposure levels and favorable tolerability to date. We believe equally that KVD001 could represent an important therapeutic alternative for DME patients, especially for those patients whose disease is inadequately treated with anti-VEGF."
In addition to KVD900 and KVD001, KalVista's next clinical stage oral plasma kallikrein inhibitor, KVD824, has now completed dosing in a first-in-human study. Preliminary data show high exposure levels and no concerning tolerability signals in single ascending dose, multiple ascending dose, and food effect cohorts. KVD824 also demonstrated significant effects in relevant pharmacology models of HAE and DME which support progression of the compound in either indication. The Company is conducting additional formulation work to optimize the exposure profile of the drug before deciding which indication to pursue. This additional work is expected to be completed in 2019 and KalVista is currently planning to initiate a Phase 2 clinical trial in the chosen indication in the first half of 2020.
Fiscal 2019 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. The Company has selected KVD900 as its program to be advanced as an on-demand therapy for HAE attacks and commenced a Phase 2 proof-of-concept study in HAE patients in late 2018. In DME, KalVista's most advanced program, an intravitreally administered plasma kallikrein inhibitor known as KVD001, began a Phase 2 clinical trial in 2017 that is anticipated to complete in the second half of 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 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. | |||||||
| Condensed Consolidated Balance Sheets | |||||||
| (in thousands, except share and per share amounts) | |||||||
| (Unaudited) | |||||||
| April 30, | April 30, | ||||||
| 2019 | 2018 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 32,006 | $ | 51,055 | |||
| Marketable securities | 68,805 | - | |||||
| Research and development tax credit receivable | 11,315 | 6,834 | |||||
| Prepaid expenses and other current assets | 3,420 | 1,491 | |||||
| Total current assets | 115,546 | 59,380 | |||||
| Other assets | 173 | 173 | |||||
| Property and equipment, net | 2,413 | 1,836 | |||||
| Total assets | $ | 118,132 | $ | 61,389 | |||
| Liabilities and Stockholders' Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 2,860 | $ | 1,433 | |||
| Accrued expenses | 5,593 | 3,087 | |||||
| Deferred revenue - current portion | 9,545 | 18,475 | |||||
| Capital lease liability - current portion | 54 | 221 | |||||
| Total current liabilities | 18,052 | 23,216 | |||||
| Long-term liabilities: | |||||||
| Deferred revenue - net of current portion | 3,342 | 10,862 | |||||
| Capital lease liability - net of current portion | - | 58 | |||||
| Total long-term liabilities | 3,342 | 10,920 | |||||
| Stockholders' equity: | |||||||
| Common stock, $0.001 par value | 17 | 11 | |||||
| Additional paid-in capital | 191,123 | 100,011 | |||||
| Accumulated deficit | (92,476 | ) | (71,660 | ) | |||
| Accumulated other comprehensive loss | (1,926 | ) | (1,109 | ) | |||
| Total stockholders' equity | 96,738 | 27,253 | |||||
| Total liabilities and stockholders' equity | $ | 118,132 | $ | 61,389 |
| 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, | ||||||||||||||
| 2019 | 2018 | 2019 | 2018 | ||||||||||||
| Revenue | $ | 2,926 | $ | 4,840 | $ | 16,127 | $ | 8,394 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 11,139 | 5,852 | 35,021 | 18,237 | |||||||||||
| General and administrative | 3,047 | 1,957 | 10,926 | 8,862 | |||||||||||
| Total operating expenses | 14,186 | 7,809 | 45,947 | 27,099 | |||||||||||
| Operating loss | (11,260 | ) | (2,969 | ) | (29,820 | ) | (18,705 | ) | |||||||
| Other income: | |||||||||||||||
| Interest income | 381 | 65 | 1,397 | 82 | |||||||||||
| Foreign currency exchange rate gain (loss) | (34 | ) | 262 | 49 | (1,574 | ) | |||||||||
| Other income | 2,511 | 1,985 | 7,682 | 4,392 | |||||||||||
| Total other income | 2,858 | 2,312 | 9,128 | 2,900 | |||||||||||
| Loss before income taxes | (8,402 | ) | (657 | ) | (20,692 | ) | (15,805 | ) | |||||||
| Income tax expense | 124 | - | 124 | - | |||||||||||
| Net loss | $ | (8,526 | ) | $ | (657 | ) | $ | (20,816 | ) | $ | (15,805 | ) | |||
| Net loss per share, basic and diluted | $ | (0.49 | ) | $ | (0.06 | ) | $ | (1.38 | ) | $ | (1.53 | ) | |||
| Weighted average common shares outstanding, basic and diluted | 17,253,938 | 10,797,055 | 15,080,863 | 10,321,780 |
| KalVista Pharmaceuticals Inc. | |||||||
| Condensed Consolidated Statements of Cash Flows | |||||||
| (in thousands, unaudited) | |||||||
| Years Ended | |||||||
| April 30 | |||||||
| 2019 | 2018 | ||||||
| Cash Flows from Operating Activities | |||||||
| Net loss | $ | (20,816 | ) | $ | (15,805 | ) | |
| Adjustments to reconcile net loss to net cash (used in) provided by operating activities | |||||||
| Depreciation and amortization | 378 | 180 | |||||
| Stock-based compensation expense | 2,966 | 1,060 | |||||
| Realized (gain) loss from available for sale securities | (23 | ) | - | ||||
| Foreign currency remeasurement gain | (80 | ) | (651 | ) | |||
| Changes in operating assets and liabilities: | |||||||
| Research and development tax credit receivable | (4,883 | ) | (4,256 | ) | |||
| Grants and other receivables | - | 319 | |||||
| Prepaid expenses and other current assets | (1,979 | ) | (746 | ) | |||
| Other assets | - | (123 | ) | ||||
| Accounts payable | 1,534 | 217 | |||||
| Accrued expenses | 2,665 | 1,132 | |||||
| Deferred revenue | (16,127 | ) | 29,231 | ||||
| Net cash (used in) provided by operating activities | (36,365 | ) | 10,558 | ||||
| Cash Flows from Investing Activities | |||||||
| Purchases of available for sale securities | (79,889 | ) | - | ||||
| Sales and maturities of available for sale securities | 11,548 | - | |||||
| Acquisition of property and equipment | (1,081 | ) | (1,427 | ) | |||
| Net cash used in investing activities | (69,422 | ) | (1,427 | ) | |||
| Cash Flows from Financing Activities | |||||||
| Proceeds from issuance of common stock, net of issuance costs | 87,910 | 9,137 | |||||
| Proceeds from issuance of common stock from exercise of stock options | 242 | - | |||||
| Capital lease principal payments | (209 | ) | (151 | ) | |||
| Net cash provided by financing activities | 87,943 | 8,986 | |||||
| Effect of exchange rate changes on cash and cash equivalents | (1,205 | ) | 1,988 | ||||
| Net (decrease) increase in cash and cash equivalents | (19,049 | ) | 20,105 | ||||
| Cash and cash equivalents, beginning of year | 51,055 | 30,950 | |||||
| Cash and cash equivalents, end of year | $ | 32,006 | $ | 51,055 |
KalVista Pharmaceuticals, Inc.
Senior Director, Corporate Communications & Investor Relations