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): March 16, 2018
KALVISTA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
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Delaware |
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001-36830 |
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20-0915291 |
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(State or Other Jurisdiction of Incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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55 Cambridge Parkway Suite 901E Cambridge, Massachusetts |
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(Address of Principal Executive Offices) (Zip Code)
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(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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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. ☒ |
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On March 16, 2018, KalVista Pharmaceuticals, Inc. (the “Company”) reported its financial results for the three months ended January 31, 2018. 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.
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Item 9.01. |
Financial Statements and Exhibits. |
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Exhibit |
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Description |
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99.1 |
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2
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.
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KALVISTA PHARMACEUTICALS, INC. |
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Date: March 16, 2018 |
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By: |
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/s/ Benjamin L. Palleiko |
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Benjamin L. Palleiko |
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Chief Financial Officer |
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KalVista Pharmaceuticals Reports Fiscal Third Quarter Results
– Enrollment Ongoing for a Phase 2 Clinical Trial of KVD001 in Diabetic Macular Edema (“DME”) and a Phase 1 Clinical Trial for the Second Candidate in the Oral Hereditary Angioedema (“HAE”) Portfolio –
Cambridge, MA, March 16, 2018 – 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 third quarter ended January 31, 2018.
“We are pleased to have the second candidate from our oral hereditary angioedema portfolio in a Phase 1 trial as we continue to pursue a best-in-class therapy,” said Andrew Crockett, Chief Executive Officer of KalVista. “Our diabetic macular edema compound KVD001 is enrolling in a Phase 2 clinical trial for which we expect to see data in the second half of 2019. The cash position of KalVista continues to be sufficient to reach data readouts in both of these ongoing trials.”
Recent Business Highlights:
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Announced initiation of two clinical trials: A Phase 2 proof-of-concept clinical trial evaluating the safety, tolerability, and efficacy of KVD001 as a treatment for DME, as well as a Phase 1 trial for KVD900, the second clinical candidate in the HAE portfolio. KalVista also intends to bring at least one additional HAE drug candidate to the clinic before the end of 2018. |
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KalVista’s Chief Scientific Officer, Edward Feener, Ph.D., presented at The International Symposium on Ocular Pharmacology and Therapeutics (ISOPT) on March 2, 2018, in Tel-Aviv, Israel. |
Upcoming Events:
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Presenting “A Novel Oral Plasma Kallikrein (PKal) Inhibitor KV123833 Blocks VEGF-Mediated Retinal Vascular Hyperpermeability in a Murine Model of Retinal Edema,” at The Association for Research in Vision and Ophthalmology (ARVO) on May 1, 2018, in Honolulu, Hawaii. |
Fiscal Third Quarter Financial Results:
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Revenue: Revenue was $2.3 million for the three months ended January 31, 2018, compared to $0.2 million for the same period in 2017. The increase in revenue is primarily due to revenue recognized from the Merck option agreement. |
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R&D Expenses: Research and development expenses were $4.5 million for the three months ended January 31, 2018, compared to $3.3 million for the same period in 2017. The increase in R&D expense is due to an overall increase in research activities, primarily driven by the KVD001 Phase 2 trial as well as spending on our other development programs. |
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and payroll expenses related to the share purchase transaction with Carbylan Therapeutics, Inc. in the prior year. |
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Net Loss: Net loss was $5.2 million, or $(0.49) per basic and diluted share for the three months ended January 31, 2018, compared to a net loss of $7.6 million, or $(1.03) per basic and diluted share, for the same period in 2017. |
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Cash: Cash and cash equivalents were $58.7 million as of January 31, 2018. |
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. 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 began a Phase 2 clinical trial 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. |
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Condensed Consolidated Balance Sheets |
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(in thousands, except share and per share amounts) |
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(Unaudited) |
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January 31, |
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April 30, |
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2018 |
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2017 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ |
58,678 |
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$ |
30,950 |
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Research and development tax credit receivable |
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4,989 |
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2,250 |
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Grants and other receivables |
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40 |
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297 |
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Prepaid expenses and other current assets |
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2,003 |
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701 |
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Total current assets |
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65,710 |
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34,198 |
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Other assets |
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173 |
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50 |
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Property and equipment, net |
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774 |
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97 |
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Total assets |
$ |
66,657 |
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$ |
34,345 |
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Liabilities and Stockholders' Equity |
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Accounts payable |
$ |
1,575 |
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$ |
1,153 |
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Accrued expenses |
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2,290 |
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1,865 |
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Deferred revenue - current portion |
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19,996 |
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- |
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Capital lease liability - current portion |
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222 |
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- |
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Total current liabilities |
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24,083 |
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3,018 |
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Long-term liabilities: |
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Deferred revenue - net of current portion |
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13,889 |
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- |
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Capital lease liability, net of current portion |
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117 |
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- |
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Total long-term liabilities |
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14,006 |
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- |
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Stockholders’ equity |
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Common stock, $0.001 par value |
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11 |
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10 |
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Additional paid-in capital |
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99,696 |
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89,815 |
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Accumulated deficit |
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(71,003 |
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(55,855 |
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Accumulated other comprehensive loss |
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(136 |
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(2,643 |
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Total stockholders’ equity |
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28,568 |
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31,327 |
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Total liabilities and stockholders' equity |
$ |
66,657 |
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$ |
34,345 |
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3
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KalVista Pharmaceuticals Inc. |
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Condensed Consolidated Statements of Operations |
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(in thousands, except share and per share amounts) |
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(Unaudited) |
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Three Months Ended |
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Nine Months Ended |
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January 31, |
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January 31, |
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2018 |
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2017 |
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2018 |
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2017 |
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Revenue |
$ |
2,331 |
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$ |
248 |
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$ |
3,554 |
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$ |
1,390 |
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Operating expenses: |
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Research and development |
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4,548 |
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3,339 |
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12,385 |
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9,670 |
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General and administrative |
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2,129 |
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5,026 |
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6,905 |
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8,973 |
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Total operating expenses |
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6,677 |
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8,365 |
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19,290 |
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18,643 |
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Operating loss |
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(4,346 |
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(8,117 |
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(15,736 |
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(17,253 |
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Other income (expense): |
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Interest income |
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14 |
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7 |
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17 |
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31 |
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Foreign currency exchange gain (loss) |
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(1,887 |
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(195 |
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(1,836 |
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1,511 |
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Other income |
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985 |
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661 |
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2,407 |
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1,310 |
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Total other income |
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(888 |
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473 |
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588 |
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2,852 |
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Net loss |
$ |
(5,234 |
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$ |
(7,644 |
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$ |
(15,148 |
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$ |
(14,401 |
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Net loss per share to common stockholders, basic and diluted |
$ |
(0.49 |
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$ |
(1.03 |
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$ |
(1.49 |
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$ |
(5.50 |
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Weighted average common shares outstanding, basic and diluted |
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10,788,556 |
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7,657,874 |
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10,168,520 |
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3,013,073 |
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4
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KalVista Pharmaceuticals Inc. |
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Condensed Consolidated Statements of Cash Flows |
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(in thousands, unaudited) |
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Nine Months Ended |
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January 31 |
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2018 |
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2017 |
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Cash Flows from Operating Activities |
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Net loss |
$ |
(15,148 |
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$ |
(14,401 |
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Adjustments to reconcile net loss to net cash provided by (used in) operating activities: |
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Depreciation and amortization |
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129 |
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29 |
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Stock-based compensation |
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779 |
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228 |
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Foreign currency remeasurement (gain) loss |
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(500 |
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(1,464 |
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Changes in operating assets and liabilities: |
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Research and development tax credit receivable |
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(2,383 |
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(1,303 |
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Prepaid expenses and other current assets |
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(1,206 |
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(689 |
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Grants and other receivables |
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281 |
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36 |
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Other assets |
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(123 |
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- |
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Accounts payable |
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548 |
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(1,957 |
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Accrued expenses |
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332 |
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(1,560 |
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Deferred revenue |
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33,804 |
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- |
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Net cash provided by (used in) operating activities |
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16,513 |
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(21,081 |
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Cash Flows from Investing Activities |
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Cash acquired in transaction |
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- |
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34,139 |
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Acquisition of property and equipment |
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(343 |
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(67 |
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Net cash provided by (used in) investing activities |
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(343 |
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34,072 |
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Cash Flows from Financing Activities |
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Capital lease principal payments |
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(101 |
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- |
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Issuance of common stock |
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9,100 |
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2 |
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Net cash from financing activities |
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8,999 |
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2 |
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Effect of exchange rate changes on cash |
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2,559 |
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(1,259 |
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Net increase in cash and cash equivalents |
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27,728 |
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11,734 |
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Cash and cash equivalents, beginning of period |
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30,950 |
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21,764 |
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Cash and cash equivalents, end of period |
$ |
58,678 |
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$ |
33,498 |
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5