Full Press Release Details
KalVista Pharmaceuticals Reports Fiscal Second Quarter Results
- KVD900 Enlarged Phase 2 Trial on Track for Potential On-Demand Treatment of Attacks in Patients with Hereditary Angioedema -
- Intravitreal Diabetic Macular Edema Candidate KVD001 Phase 2 Trial Enrollment on Track with Completion Expected in H2 2019 -
- Operations Funded into 2021 -
Cambridge, MA and Salisbury, England, December 14, 2018 - 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 second quarter ended October 31, 2018.
"We are still on track with our robust Phase 2 study for KVD900 as a potential acute therapy for patients with hereditary angioedema, or HAE," said Andrew Crockett, Chief Executive Officer of KalVista. "Our intention is to have an aggressive development plan for KVD900, and use this Phase 2 data set as a basis for discussions with regulators about a faster approval pathway. KVD001, our intravitreal candidate for potential treatment of diabetic macular edema, or DME, currently enrolling a Phase 2 clinical trial, will complete in the second half of 2019."
Second Quarter and Recent Business Highlights:
Presentation Date: Saturday, February 23, 2019
Presentation Time: 9:45am-10:45am PT
Abstract Title: KVD900 as a Single Dose, Rapid, Oral Plasma Kallikrein Inhibitor for the On-Demand Treatment of Hereditary Angioedema Attacks: Pharmacokinetic and Pharmacodynamic results from a Phase 1 Single Ascending Dose Study.
Session: 2209; Poster 116
Session Title: Urticaria and Angioedema
Fiscal Second 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 into Phase 1 clinical trials for HAE. The Company has selected KVD900 as its program to be advanced as an on-demand therapy for HAE attacks, and anticipates commencing 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 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 30, 2018 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 & Investor Relations
| KalVista Pharmaceuticals Inc. | |||||||
| Condensed Consolidated Balance Sheets | |||||||
| (in thousands, except share and per share amounts) | |||||||
| (Unaudited) | |||||||
| October 31, | April 30, | ||||||
| 2018 | 2018 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 121,116 | $ | 51,055 | |||
| Research and development tax credit receivable | 7,032 | 6,834 | |||||
| Prepaid expenses and other current assets | 1,922 | 1,491 | |||||
| Total current assets | 130,070 | 59,380 | |||||
| Other assets | 173 | 173 | |||||
| Property and equipment, net | 2,316 | 1,836 | |||||
| Total assets | $ | 132,559 | $ | 61,389 | |||
| Liabilities and Stockholders' Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 3,018 | $ | 1,433 | |||
| Accrued expenses | 2,994 | 3,087 | |||||
| Deferred revenue - current portion | 14,769 | 18,475 | |||||
| Capital lease liability - current portion | 157 | 221 | |||||
| Total current liabilities | 20,938 | 23,216 | |||||
| Long-term liabilities: | |||||||
| Deferred revenue - net of current portion | 4,670 | 10,862 | |||||
| Capital lease liability - net of current portion | - | 58 | |||||
| Total long-term liabilities | 4,670 | 10,920 | |||||
| Stockholders' equity: | |||||||
| Common stock, $0.001 par value | 17 | 11 | |||||
| Additional paid-in capital | 189,164 | 100,011 | |||||
| Accumulated deficit | (79,994 | ) | (71,660 | ) | |||
| Accumulated other comprehensive loss | (2,236 | ) | (1,109 | ) | |||
| Total stockholders' equity | 106,951 | 27,253 | |||||
| Total liabilities and stockholders' equity | $ | 132,559 | $ | 61,389 |
| KalVista Pharmaceuticals Inc. | |||||||||||||||
| Condensed Consolidated Statement of Operations | |||||||||||||||
| (in thousands, except share and per share amounts) | |||||||||||||||
| (Unaudited) | |||||||||||||||
| Three Months Ended | Six Months Ended | ||||||||||||||
| October 31, | October 31, | ||||||||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||||||||
| Revenue | $ | 5,592 | $ | 1,127 | $ | 9,311 | $ | 1,223 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 7,876 | 4,361 | 16,232 | 7,837 | |||||||||||
| General and administrative | 2,609 | 2,703 | 4,979 | 4,776 | |||||||||||
| Total operating expenses | 10,485 | 7,064 | 21,211 | 12,613 | |||||||||||
| Operating loss | (4,893 | ) | (5,937 | ) | (11,900 | ) | (11,390 | ) | |||||||
| Other income: | |||||||||||||||
| Interest income | 204 | 1 | 293 | 3 | |||||||||||
| Foreign currency exchange rate gain (loss) | (231 | ) | 83 | (165 | ) | 51 | |||||||||
| Other income | 1,616 | 867 | 3,438 | 1,422 | |||||||||||
| Total other income | 1,589 | 951 | 3,566 | 1,476 | |||||||||||
| Net loss | $ | (3,304 | ) | $ | (4,986 | ) | $ | (8,334 | ) | $ | (9,914 | ) | |||
| Net loss per share to common stockholders, basic and diluted | $ | (0.22 | ) | $ | (0.50 | ) | $ | (0.64 | ) | $ | (1.01 | ) | |||
| Weighted average common shares outstanding, basic and diluted | 15,108,272 | 10,003,963 | 12,954,083 | 9,858,502 |
| KalVista Pharmaceuticals Inc. | |||||||
| Condensed Consolidated Statements of Cash Flows | |||||||
| (in thousands, unaudited) | |||||||
| Six Months Ended | |||||||
| October 31 | |||||||
| 2018 | 2017 | ||||||
| Cash Flows from Operating Activities | |||||||
| Net loss | $ | (8,334 | ) | $ | (9,914 | ) | |
| Adjustments to reconcile net loss to net cash used in operating activities | |||||||
| Depreciation and amortization | 153 | 79 | |||||
| Stock-based compensation expense | 1,323 | 494 | |||||
| Foreign currency remeasurement loss | 226 | 31 | |||||
| Changes in operating assets and liabilities: | |||||||
| Research and development tax credit receivable | (692 | ) | (1,397 | ) | |||
| Prepaid expenses and other current assets | (517 | ) | (636 | ) | |||
| Grants and other receivables | - | (590 | ) | ||||
| Accounts payable | 2,088 | (139 | ) | ||||
| Accrued expenses | 66 | 365 | |||||
| Deferred revenue | (9,311 | ) | - | ||||
| Net cash used in operating activities | (14,998 | ) | (11,707 | ) | |||
| Cash Flows from Investing Activities | |||||||
| Acquisition of property and equipment | (786 | ) | (161 | ) | |||
| Net cash used in investing activities | (786 | ) | (161 | ) | |||
| Cash Flows from Financing Activities | |||||||
| Capital lease principal payments | (104 | ) | (49 | ) | |||
| Issuance of common stock from stock option exercises | 25 | - | |||||
| Issuance of common stock, net of offering expenses | 87,811 | 9,100 | |||||
| Net cash provided by financing activities | 87,732 | 9,051 | |||||
| Effect of exchange rate changes on cash and cash equivalents | (1,887 | ) | (5 | ) | |||
| Net decrease in cash and cash equivalents | 70,061 | (2,822 | ) | ||||
| Cash and cash equivalents, beginning of period | 51,055 | 30,950 | |||||
| Cash and cash equivalents, end of period | $ | 121,116 | $ | 28,128 |