Full Press Release Details
KalVista Pharmaceuticals Reports Fiscal Second Quarter Results
Regulatory Filing Submitted for Second Candidate in Oral Hereditary Angioedema
(HAE) Plasma Kallikrein Inhibitor Portfolio
Cash Through Data Inflection Points in Both HAE and Diabetic Macular Edema Programs
Cambridge, MA, December 14, 2017 KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company
focused on the discovery, development, and commercialization of small molecule protease inhibitors, today reported operational and financial results for the fiscal second quarter ended October 31, 2017.
Since announcing the collaboration agreement with Merck, we have been focused on finalizing a Phase 2 clinical trial design for KVD001 that will enable
our best chance for success, and we remain on track to initiate that trial this year, said Andrew Crockett, Chief Executive Officer of KalVista. We also submitted the regulatory filing to enter the clinic with our second oral plasma
kallikrein inhibitor candidate for potential treatment of hereditary angioedema, KVD900, and there will be at least one additional HAE portfolio candidate entering the clinic in 2018.
Recent Business Highlights:
Fiscal Second Quarter Financial Results:
About KalVista Pharmaceuticals, Inc.
Pharmaceuticals, Inc. is a pharmaceuticals 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 from which it plans to select multiple drug
candidates to advance into clinical trials for HAE. KalVista s most advanced program, an intravitreally administered plasma kallikrein inhibitor known as KVD001, has successfully completed its first-in-human study in patients with DME and is being prepared for Phase 2 studies in 2017.
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 and 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 27, 2017, our most recent Quarterly Report on Form 10-Q, 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.
Director, Corporate Communications &
KalVista Pharmaceuticals Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
| October 31, 2017 | April 30, 2017 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 28,128 | $ | 30,950 | ||||
| Research and development tax credit receivable | 3,718 | 2,250 | ||||||
| Grants and other receivables | 893 | 297 | ||||||
| Prepaid expenses and other current assets | 1,400 | 751 | ||||||
| Total current assets | 34,139 | 34,248 | ||||||
| Property and equipment, net | 602 | 97 | ||||||
| Total assets | $ | 34,741 | $ | 34,345 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Accounts payable | $ | 1,040 | $ | 1,153 | ||||
| Accrued expenses | 2,253 | 1,865 | ||||||
| Capital lease liability - current portion | 220 | |||||||
| Total current liabilities | 3,513 | 3,018 | ||||||
| Long-term liabilities: | ||||||||
| Capital lease liability, net of current portion | 149 | |||||||
| Total long-term liabilities | 149 | |||||||
| Stockholders equity | ||||||||
| Common stock, $0.001 par value | 11 | 10 | ||||||
| Additional paid-in capital | 99,408 | 89,815 | ||||||
| Accumulated deficit | (65,769 | ) | (55,855 | ) | ||||
| Accumulated other comprehensive loss | (2,571 | ) | (2,643 | ) | ||||
| Total stockholders equity | 31,079 | 31,327 | ||||||
| Total liabilities and stockholders' equity | $ | 34,741 | $ | 34,345 |
KalVista Pharmaceuticals Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
| Three Months Ended October 31, | Six Months Ended October 31, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Revenue | $ | 1,127 | $ | 197 | $ | 1,223 | $ | 1,141 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 4,361 | 2,929 | 7,837 | 6,330 | ||||||||||||
| General and administrative | 2,703 | 1,293 | 4,776 | 3,946 | ||||||||||||
| Total operating expenses | 7,064 | 4,222 | 12,613 | 10,276 | ||||||||||||
| Operating loss | (5,937 | ) | (4,025 | ) | (11,390 | ) | (9,135 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 1 | 10 | 3 | 24 | ||||||||||||
| Foreign currency exchange gain (loss) | 83 | 352 | 51 | 1,706 | ||||||||||||
| Other income | 867 | 368 | 1,422 | 650 | ||||||||||||
| Total other income | 951 | 730 | 1,476 | 2,380 | ||||||||||||
| Net loss | $ | (4,986 | ) | $ | (3,295 | ) | $ | (9,914 | ) | $ | (6,755 | ) | ||||
| Net loss per share to common stockholders, basic and diluted | $ | (0.50 | ) | $ | (5.98 | ) | $ | (1.01 | ) | $ | (12.66 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 10,003,963 | 709,500 | 9,858,502 | 690,719 |
KalVista Pharmaceuticals Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands, unaudited)
| Six Months Ended October 31 | ||||||||
| 2017 | 2016 | |||||||
| Cash Flows from Operating Activities | ||||||||
| Net loss | $ | (9,914 | ) | $ | (6,756 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation expense | 79 | 19 | ||||||
| Stock-based compensation | 494 | 67 | ||||||
| Foreign currency exchange rate (gain) loss | 31 | (1,706 | ) | |||||
| Changes in operating assets and liabilities: | ||||||||
| Research and development tax credit receivable | (1,397 | ) | (650 | ) | ||||
| Prepaid expenses and other current assets | (636 | ) | 272 | |||||
| Grants and other receivables | (590 | ) | 148 | |||||
| Accounts payable | (139 | ) | (74 | ) | ||||
| Accrued expenses | 365 | (1,122 | ) | |||||
| Due to related parties | (39 | ) | ||||||
| Net cash used in operating activities | (11,707 | ) | (9,841 | ) | ||||
| Cash Flows from Investing Activities | ||||||||
| Acquisition of property and equipment | (161 | ) | (61 | ) | ||||
| Net cash used in investing activities | (161 | ) | (61 | ) | ||||
| Cash Flows from Financing Activities | ||||||||
| Capital lease principal payments | (49 | ) | ||||||
| Issuance of common stock | 9,100 | |||||||
| Net cash provided by financing activities | 9,051 | |||||||
| Effect of exchange rate changes on cash | (5 | ) | (1,177 | ) | ||||
| Net decrease in cash and cash equivalents | (2,822 | ) | (11,079 | ) | ||||
| Cash and cash equivalents, beginning of year | 30,950 | 21,764 | ||||||
| Cash and cash equivalents, end of year | $ | 28,128 | $ | 10,685 |