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 –
“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
Recent Business Highlights:
-
Announced collaboration with Merck for investigational plasma
kallikrein inhibitors for treatment of diabetic macular edema (DME).
Under the terms of the agreement, KalVista has granted to Merck
certain rights including an option to acquire KVD001 through a period
following completion of the Phase 2 proof-of-concept trial that
KalVista intends to commence this year. KalVista also granted to Merck
a similar option to acquire investigational orally delivered molecules
for DME that KalVista will continue to develop as part of its ongoing
research and development activities. Merck paid KalVista a
$37 million upfront fee and KalVista is further eligible to receive payments associated with the exercise of the options by Merck and the achievement of milestones for each program that potentially total up to$715 million . KalVista also will receive tiered royalties on net sales for therapeutic candidates commercialized under this agreement. In addition to the collaboration, KalVista entered into a separate$9.1 million private placement transaction with Merck under which Merck acquired a 9.9% ownership stake in KalVista concurrent with the execution of the Option Agreement.
Fiscal Second Quarter Financial Results:
-
Revenue: Revenue was
$1.1 million for the three months endedOctober 31, 2017 , compared to$0.2 million for the same period in 2016. The increase in revenue is primarily due to revenue recognized from the Merck collaboration fee. -
R&D Expenses: Research and development expenses were
$4.4 million for the three months endedOctober 31, 2017 , compared to$2.9 million for the same period in 2016. The increase in R&D expense is due to an overall increase in research activities, primarily driven by preparations for the KVD001 Phase 2 trial as well as spending on our other development programs. -
G&A Expenses: General and administrative expenses were
$2.7 million for the three months endedOctober 31, 2017 , compared to$1.3 million for the same period in 2016. The increase was primarily due to$1.2 million of payroll related expenses and$0.2 million of other administrative expenses related to the increased cost of operations as a public company. -
Net Loss: Net loss was
$5.0 million , or$(0.50) per basic and diluted share for the three months endedOctober 31, 2017 , compared to a net loss of$3.3 million , or$(5.98) per basic and diluted share, for the same period in 2016. -
Cash: Cash and cash equivalents were
$28.1 million as ofOctober 31, 2017 . The$37 million Merck upfront payment was received inNovember 2017 .
About
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
KalVista Pharmaceuticals Inc. | ||||||||||
Condensed Consolidated Balance Sheets | ||||||||||
(in thousands, except share and per share amounts) | ||||||||||
(Unaudited) | ||||||||||
October 31, | April 30, | |||||||||
2017 | 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) | ||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||||||
October 31, | 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 |
View source version on businesswire.com: http://www.businesswire.com/news/home/20171214005189/en/
Source:
KalVista Pharmaceuticals, Inc.
Leah Monteiro, 857-999-0808
Director,
Corporate Communications & Investor Relations
leah.monteiro@kalvista.com