Full Press Release Details
KalVista Pharmaceuticals Provides Operational Update and Fiscal Year Financial Results
- KVD900 Selected to Advance to Phase 2 as Potential On-Demand Treatment of Acute Attacks in Patients with Hereditary Angioedema (HAE) -
- KVD001 Phase 2 Clinical Trial for Patients with Diabetic Macular Edema (DME) Enrollment Remains on Track with Data Expected in H2 2019 -
- $14.6 Million Financing Funds into H1 2020, Past Anticipated Key Milestones for Both Programs -
Cambridge, MA and Salisbury, England, July 31, 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 fourth quarter and full year ended April 30, 2018. KalVista also announced the sale of approximately $14.6 million in common stock to Venrock Healthcare Capital Partners (Venrock) and BVF Partners L.P. (BVF) in a registered direct transaction.
"We are pleased to announce that based upon results observed in our Phase 1 trial of KVD900, we will be moving the compound forward as a potential on-demand therapy for acute HAE attacks, and anticipate beginning a Phase 2 clinical trial before the end of 2018," said Andrew Crockett, Chief Executive Officer of KalVista. "We believe that a conveniently administered oral, on-demand product for acute HAE attacks could capture a significant portion of a currently all injectable acute market, as well as offer a better option for many patients who may currently use prophylactic therapies because of the lack of suitable options. In DME, our Phase 2 clinical trial of KVD001 continues to enroll patients and, based on recruitment rates seen to date, we remain on track to have data from this trial available in the second half of 2019. Finally, the sale of common stock to Venrock and BVF provides us with sufficient capital to advance our programs beyond the anticipated dates of key data points, funding the Company into the first half of 2020."
Fiscal 2018 Business Highlights:
HAE Portfolio Update:
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 into Phase 1 clinical trials for HAE. The Company has
selected KVD900 as its program to be advanced as an on-demand therapy for acute 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 report data 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) | |||
| April 30, | April 30, | ||
| 2018 | 2017 | ||
| Assets | |||
| Current assets: | |||
| Cash and cash equivalents | $51,055 | $30,950 | |
| Research and development tax credit receivable | 6,834 | 2,250 | |
| Grants and other receivables | - | 297 | |
| Prepaid expenses and other current assets | 1,491 | 701 | |
| Total current assets | 59,380 | 34,198 | |
| Other assets | 173 | 50 | |
| Property and equipment, net | 1,836 | 97 | |
| Total assets | $61,389 | $34,345 | |
| Liabilities and Stockholders' Equity | |||
| Current liabilities: | |||
| Accounts payable | $1,433 | $1,153 | |
| Accrued expenses | 3,087 | 1,865 | |
| Deferred revenue - current portion | 18,475 | - | |
| Capital lease liability - current portion | 221 | - | |
| Total current liabilities | 23,216 | 3,018 | |
| Long-term liabilities: | |||
| Deferred revenue - net of current portion | 10,862 | - | |
| Capital lease liability - net of current portion | 58 | - | |
| Total long-term liabilities | 10,920 | - | |
| Stockholders' equity: | |||
| Common stock, $0.001 par value | 11 | 10 | |
| Additional paid-in capital | 100,011 | 89,815 | |
| Accumulated deficit | (71,660) | (55,855) | |
| Accumulated other comprehensive loss | (1,109) | (2,643) | |
| Total stockholders' equity | 27,253 | 31,327 | |
| Total liabilities and stockholders' equity | $61,389 | $34,345 |
| 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, | |||||
| 2018 | 2017 | 2018 | 2017 | |||
| Revenue | $4,840 | $114 | $ 8,394 | $ 1,504 | ||
| Operating expenses: | ||||||
| Research and development | 5,852 | 2,996 | 18,237 | 12,666 | ||
| General and administrative | 1,957 | 2,204 | 8,862 | 11,177 | ||
| Total operating expenses | 7,809 | 5,200 | 27,099 | 23,843 | ||
| Operating loss | (2,969) | (5,086) | (18,705) | (22,339) | ||
| Other income: | ||||||
| Interest income | 65 | 5 | 82 | 36 | ||
| Foreign currency exchange rate gain (loss) | 262 | (140) | (1,574) | 1,371 | ||
| Other income | 1,985 | 1,019 | 4,392 | 2,329 | ||
| Total other income | 2,312 | 884 | 2,900 | 3,736 | ||
| Net loss | $(657) | $(4,202) | $ (15,805) | $ (18,603) | ||
| Net loss per share to common stockholders, basic and diluted | $(0.06) | $(0.43) | $ (1.53) | $ (4.47) | ||
| Weighted average common shares outstanding, basic and diluted | 10,797,055 | 9,713,042 | 10,321,780 | 4,646,764 |
| 3 KalVista Pharmaceuticals Inc. | |||
| Condensed Consolidated Statements of Cash Flows | |||
| (in thousands, unaudited) | |||
| Years Ended | |||
| April 30 | |||
| 2018 | 2017 | ||
| Cash Flows from Operating Activities | |||
| Net loss | $ (15,805) | $ (18,603) | |
| Adjustments to reconcile net loss to net cash provided by (used in) operating activities | |||
| Depreciation and amortization | 180 | 40 | |
| Stock-based compensation expense | 1,060 | 394 | |
| Foreign currency remeasurement (gain) loss | (651) | (1,371) | |
| Changes in operating assets and liabilities: | |||
| Research and development tax credit receivable | (4,256) | (600) | |
| Grants and other receivables | 319 | 29 | |
| Prepaid expenses and other current assets | (746) | (81) | |
| Other assets | (123) | - | |
| Accounts payable | 217 | (1,599) | |
| Accrued expenses | 1,132 | (1,931) | |
| Deferred revenue | 29,231 | - | |
| Net cash provided by (used in) operating activities | 10,558 | (23,722) | |
| Cash Flows from Investing Activities | |||
| Cash acquired in transaction | - | 34,139 | |
| Acquisition of property and equipment | (1,427) | (74) |
| Net cash provided by (used in) investing activities | (1,427) | 34,065 | |
| Cash Flows from Financing Activities | |||
| Capital lease principal payments | (151) | - | |
| Proceeds from issuance of common stock | 9,137 | 2 | |
| Net cash provided by financing activities | 8,986 | 2 | |
| Effect of exchange rate changes on cash and cash equivalents | 1,988 | (1,159) | |
| Net increase in cash and cash equivalents | 20,105 | 9,186 | |
| Cash and cash equivalents, beginning of year | 30,950 | 21,764 | |
| Cash and cash equivalents, end of year | $51,055 | $ 30,950 |