KalVista Pharmaceuticals Provides Operational Update and Reports Fiscal Fourth Quarter and Full Year Financial Results
– Oral Plasma Kallikrein Inhibitor Portfolio for Treatment of Hereditary Angioedema Continues to Advance –
– Intravitreal Diabetic Macular Edema Phase 2 On Track to Initiate in 2017 –
“KalVista has been making substantial advances with our portfolio of oral small molecule plasma kallikrein inhibitors for treatment of hereditary angioedema (HAE), and our intravitreal program in diabetic macular edema (DME),” said
Fiscal 2017 Business Highlights:
- Closed merger with
Carbylan Therapeutics, Inc. onNovember 21, 2016 , becoming listed on NASDAQ under the ticker symbol “KALV”. - Built out executive team with key hires
Benjamin L. Palleiko as Chief Financial Officer,Edward P. Feener , Ph.D. as Chief Scientific Officer and Andreas Maetzel, M.D., M.Sc., Ph.D. as Senior Vice President, Medical.
HAE Portfolio:
- KalVista continues to pursue a strategy of developing a portfolio of oral molecules and evaluating multiple candidates in the clinic to provide a best-in-class therapy for HAE patients. As part of this strategy, we will select molecules whose properties can support multiple therapies for HAE patients, such as for prophylactic as well as acute treatment.
- KVD818: The initial clinical candidate in our HAE portfolio is nearing completion of the first-in-human study. Early data for KVD818 indicate good exposure and a good tolerability profile. We intend to evaluate final data and determine future development plans while the other molecules in the portfolio advance.
- KVD900: Anticipated to be the next program to enter clinical testing, with regulatory filing before end of the calendar year. KVD900 represents the continual evolution of the portfolio, with a differentiated set of properties compared to KVD818 that may support development in multiple regimens of HAE therapy.
- A diverse and expanding portfolio containing multiple additional oral candidates is under development and will continue to be advanced as progression criteria are met. We anticipate at least one additional candidate will enter the clinic in 2018.
DME Programs:
- KVD001: Intravitreal therapy for DME advancing into a Phase 2 trial this year. This trial is expected to evaluate DME patients who experience an inadequate response to VEGF inhibitors. This will be a sham-controlled trial, with patients receiving four injections over a period of three months. The primary efficacy endpoint will be a change in BCVA (Best Corrected Visual Acuity) which measures a patient’s ability to read a standardized chart of letters. Other endpoints will include optical computerized tomography to assess changes in retinal thickness due to edema. We expect to provide additional details when the trial commences.
- We continue to take steps in designing an oral plasma kallikrein therapy for DME, based upon the knowledge gained through our oral HAE portfolio as well as research conducted by our Chief Scientific Officer, Dr.
Edward Feener . We believe that an orally delivered therapeutic could provide significant clinical benefit to DME patients compared to the current approved DME drugs, which are all delivered via injection.
Recent and Upcoming Events:
Edward Feener , Ph.D., gave a talk at theInternational Society on Thrombosis andHaemostasis (ISTH) Congress entitled “Contact System in Diabetic Retinopathy,” onJuly 9, 2017 inBerlin, Germany .Wedbush PacGrow Healthcare Conference onAugust 15, 2017 inNew York, NY .- 19th
Royal Society of Chemistry Medicinal Chemistry Symposium , presenting KVD001 data onSeptember 10, 2017 inCambridge, United Kingdom . - Cambridge Healthtech Institute’s Fifth Annual
Targeting Ocular Disorders Conference presentation “Plasma Kallikrein Inhibition as a VEGF-Independent Treatment for Diabetic Macular Edema,” onSeptember 28, 2017 inBoston, MA.
Fourth Quarter and Full Year Financial Results:
- Revenue: Revenue/Grant income was
$0.1 million for the three months endedApril 30, 2017 , compared to$0.3 million for the same period in the prior year. Grant income was$1.5 million for the fiscal year endedApril 30, 2017 , compared to$2.1 million in the prior year. Revenue in both periods consisted primarily of payments under the terms of a research and development grant. - R&D Expenses: Research and development expenses were
$3.0 million for the three months endedApril 30, 2017 , compared to$4.4 million for the same period in the prior year. Research and development expenses were$12.7 million for the fiscal year endedApril 30, 2017 , compared to$14.7 million in the prior year. The decline in R&D expense primarily reflects the completion of a trial for KVD001 that was ongoing in 2016 and lower spending on other programs, as well as the impact of a decline in the value of the British Pound on the costs of KalVista’s scientific operations in theU.K. - G&A Expenses: General and administrative expenses were
$2.2 million for the three months endedApril 30, 2017 , compared to$1.0 million for the same period in the prior year. General and administrative expenses were$11.2 million for the fiscal year endedApril 30, 2017 , compared to$2.7 million in the prior year. This was primarily due to costs associated with the share purchase transaction completed inNovember 2016 and additional payroll costs and other expenses as we expanded the management team and other key positions, and incur costs associated with operations as a public company. - Net Loss: Net loss was
$4.2 million , or$0.43 per weighted average basic and diluted share, for the three months endedApril 30, 2017 , compared to net loss of$4.9 million , or$9.37 per share for the same period in the prior year. Net loss was$18.6 million , or$4.47 per weighted average basic and diluted share for the fiscal year endedApril 30, 2017 , compared to a net loss of$11.4 million , or$26.17 per weighted average basic and diluted share in the prior year. This increase in the net loss was primarily due to costs associated with the share purchase transaction completed inNovember 2016 and additional payroll costs and other expenses as we expand the management team and other key positions, and incur costs associated with operations as a public company. - Cash Position: Cash and cash equivalents were
$31.0 million as ofApril 30, 2017 , compared to$21.8 million as ofApril 30, 2016 .
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 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 definitive proxy statement filed on
KalVista Pharmaceuticals Inc. | |||||||
Condensed Consolidated Balance Sheets | |||||||
(in thousands, except share and per share amounts) | |||||||
(Unaudited) | |||||||
April 30, | April 30, | ||||||
2017 |
2016 |
||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 30,950 | $ | 21,764 | |||
Research and development tax credit receivable | 2,250 | 1,883 | |||||
Grants receivable | 297 | 356 | |||||
Prepaid expenses and other current assets | 751 | 668 | |||||
Total current assets | 34,248 | 24,671 | |||||
Property and equipment, net | 97 | 74 | |||||
Total assets | $ | 34,345 | $ | 24,745 | |||
Liabilities and Stockholders' Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,153 | $ | 1,135 | |||
Accrued expenses | 1,865 | 2,114 | |||||
Total current liabilities | 3,018 | 3,249 | |||||
Redeemable Convertible Preferred Stock, $0.0016 par value | - | 58,608 | |||||
Stockholders’ equity (deficit) | |||||||
Ordinary shares, $0.0016 par value | - | 3 | |||||
Common stock, $0.001 par value | 10 | - | |||||
Additional paid-in capital | 89,815 | 212 | |||||
Accumulated deficit | (55,855 | ) | (37,252 | ) | |||
Accumulated other comprehensive loss | (2,643 | ) | (75 | ) | |||
Total stockholders’ equity (deficit) | 31,327 | (37,112 | ) | ||||
Total liabilities and stockholders' equity | $ | 34,345 | $ | 24,745 | |||
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, | ||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||
Grant income | $ | 114 | $ | 314 | $ | 1,504 | $ | 2,133 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 2,996 | 4,414 | 12,666 | 14,661 | |||||||||||
General and administrative | 2,204 | 986 | 11,177 | 2,653 | |||||||||||
Total operating expenses | 5,200 | 5,400 | 23,843 | 17,314 | |||||||||||
Operating loss | (5,086 | ) | (5,086 | ) | (22,339 | ) | (15,181 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest income | 5 | 18 | 36 | 50 | |||||||||||
Foreign currency exchange rate gain (loss) | (140 | ) | (508 | ) | 1,371 | 1,661 | |||||||||
Other income | 1,019 | 707 | 2,329 | 2,034 | |||||||||||
Total other income | 884 | 217 | 3,736 | 3,745 | |||||||||||
Net loss | $ | (4,202 | ) | $ | (4,869 | ) | $ | (18,603 | ) | $ | (11,436 | ) | |||
Net loss per share to common stockholders, basic and diluted | $ | (0.43 | ) | $ | (9.37 | ) | $ | (4.47 | ) | $ | (26.17 | ) | |||
Weighted average common shares outstanding, basic and diluted | 9,713,042 | 630,921 | 4,646,764 | 591,298 |
KalVista Pharmaceuticals Inc. | ||||||||
Condensed Consolidated Statements of Cash Flows | ||||||||
(in thousands, unaudited) | ||||||||
Years Ended | ||||||||
April 30 | ||||||||
2017 | 2016 | |||||||
Cash Flows from Operating Activities | ||||||||
Net loss | $ | (18,603 | ) | $ | (11,436 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities | ||||||||
Depreciation expense | 40 | 33 | ||||||
Stock-based compensation | 394 | 118 | ||||||
Foreign currency exchange rate gain | (1,371 | ) | (1,661 | ) | ||||
Changes in operating assets and liabilities: | ||||||||
Research and development tax credit receivable | (600 | ) | (1,148 | ) | ||||
Prepaid expenses and other current assets | (81 | ) | (137 | ) | ||||
Grants receivable | 29 | (475 | ) | |||||
Accounts payable | (1,599 | ) | 374 | |||||
Accrued expenses | (1,931 | ) | 1,176 | |||||
Net cash used in operating activities | (23,722 | ) | (13,156 | ) | ||||
Cash Flows from Investing Activities | ||||||||
Cash acquired in transaction | 34,139 | - | ||||||
Purchases of property and equipment | (74 | ) | (11 | ) | ||||
Net cash provided by (used in) investing activities | 34,065 | (11 | ) | |||||
Cash Flows from Financing Activities | ||||||||
Proceeds from issuance of preferred stock | - | 33,002 | ||||||
Proceeds from issuance of common stock | 2 | 1 | ||||||
Net cash provided by financing activities | 2 | 33,003 | ||||||
Effect of exchange rate changes on cash | (1,159 | ) | (598 | ) | ||||
Net increase in cash and cash equivalents | 9,186 | 19,238 | ||||||
Cash and cash equivalents, beginning of year | 21,764 | 2,526 | ||||||
Cash and cash equivalents, end of year | $ | 30,950 | $ | 21,764 | ||||
Contact:KalVista Pharmaceuticals , Inc.Leah Monteiro ,Corporate Communications & Investor Relations 857-999-0808 lmm@KalVista.com