UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 14, 2017
KALVISTA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
| Delaware | 001-36830 | 20-0915291 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) | ||
| 55 Cambridge Parkway Suite 901E Cambridge, Massachusetts | ||||
| (Address of Principal Executive Offices) (Zip Code) | ||||
(857) 999-0075
(Registrant’s telephone number, including area code)
One Kendall Square
Building 200, Suite 2203
Cambridge, Massachusetts 02139
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
| Item 2.02. | Results of Operations and Financial Condition. |
On December 14, 2017, KalVista Pharmaceuticals, Inc. (the “Company”) reported its financial results for the three months ended October 31, 2017. A copy of the press release issued by the Company is furnished as Exhibit 99.1 to this report.
The information furnished with Item 2.02 of this report, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Exchange Act or under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
| Item 9.01. | Financial Statements and Exhibits. |
| Exhibit |
Description | |
| 99.1 | Press release dated December 14, 2017. | |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| KALVISTA PHARMACEUTICALS, INC. | ||||||
| Date: December 14, 2017 | By: | /s/ Benjamin L. Palleiko | ||||
| Benjamin L. Palleiko | ||||||
| Chief Financial Officer | ||||||
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Exhibit 99.1
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:
| • | 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 ended October 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 ended October 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. |
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| • | G&A Expenses: General and administrative expenses were $2.7 million for the three months ended October 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 ended October 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 of October 31, 2017. The $37 million Merck upfront payment was received in November 2017. |
About KalVista Pharmaceuticals, Inc.
KalVista 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.
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 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.
Contact:
KalVista Pharmaceuticals, Inc.
Leah Monteiro
Director, Corporate Communications & Investor Relations
857-999-0808
leah.monteiro@kalvista.com
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KalVista Pharmaceuticals Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
(Unaudited)
| October 31, 2017 |
April 30, 2017 |
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| Assets |
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| Current assets: |
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| 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 | ||||||
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| Total current assets |
34,139 | 34,248 | ||||||
| Property and equipment, net |
602 | 97 | ||||||
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| Total assets |
$ | 34,741 | $ | 34,345 | ||||
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| Liabilities and Stockholders' Equity |
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| Accounts payable |
$ | 1,040 | $ | 1,153 | ||||
| Accrued expenses |
2,253 | 1,865 | ||||||
| Capital lease liability - current portion |
220 | — | ||||||
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| Total current liabilities |
3,513 | 3,018 | ||||||
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| Long-term liabilities: |
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| Capital lease liability, net of current portion |
149 | — | ||||||
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| Total long-term liabilities |
149 | — | ||||||
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| Stockholders’ equity |
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| 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 | ) | ||||
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| Total stockholders’ equity |
31,079 | 31,327 | ||||||
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| Total liabilities and stockholders' equity |
$ | 34,741 | $ | 34,345 | ||||
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KalVista Pharmaceuticals Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
| Three Months Ended October 31, |
Six Months Ended October 31, |
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| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Revenue |
$ | 1,127 | $ | 197 | $ | 1,223 | $ | 1,141 | ||||||||
| Operating expenses: |
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| Research and development |
4,361 | 2,929 | 7,837 | 6,330 | ||||||||||||
| General and administrative |
2,703 | 1,293 | 4,776 | 3,946 | ||||||||||||
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| Total operating expenses |
7,064 | 4,222 | 12,613 | 10,276 | ||||||||||||
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| Operating loss |
(5,937 | ) | (4,025 | ) | (11,390 | ) | (9,135 | ) | ||||||||
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| Other income (expense): |
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| Interest income |
1 | 10 | 3 | 24 | ||||||||||||
| Foreign currency exchange gain (loss) |
83 | 352 | 51 | 1,706 | ||||||||||||
| Other income |
867 | 368 | 1,422 | 650 | ||||||||||||
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| Total other income |
951 | 730 | 1,476 | 2,380 | ||||||||||||
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| Net loss |
$ | (4,986 | ) | $ | (3,295 | ) | $ | (9,914 | ) | $ | (6,755 | ) | ||||
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| 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 | ||||||||||||
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KalVista Pharmaceuticals Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands, unaudited)
| Six Months Ended October 31 |
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| 2017 | 2016 | |||||||
| Cash Flows from Operating Activities |
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| Net loss |
$ | (9,914 | ) | $ | (6,756 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: |
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| Depreciation expense |
79 | 19 | ||||||
| Stock-based compensation |
494 | 67 | ||||||
| Foreign currency exchange rate (gain) loss |
31 | (1,706 | ) | |||||
| Changes in operating assets and liabilities: |
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| 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 | ) | |||||
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| Net cash used in operating activities |
(11,707 | ) | (9,841 | ) | ||||
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| Cash Flows from Investing Activities |
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| Acquisition of property and equipment |
(161 | ) | (61 | ) | ||||
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| Net cash used in investing activities |
(161 | ) | (61 | ) | ||||
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| Cash Flows from Financing Activities |
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| Capital lease principal payments |
(49 | ) | — | |||||
| Issuance of common stock |
9,100 | — | ||||||
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| Net cash provided by financing activities |
9,051 | — | ||||||
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| Effect of exchange rate changes on cash |
(5 | ) | (1,177 | ) | ||||
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| Net decrease in cash and cash equivalents |
(2,822 | ) | (11,079 | ) | ||||
| Cash and cash equivalents, beginning of year |
30,950 | 21,764 | ||||||
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| Cash and cash equivalents, end of year |
$ | 28,128 | $ | 10,685 | ||||
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