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): August 4, 2016
MIRATI THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware |
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001-35921 |
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46-2693615 |
(State of incorporation) |
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(Commission File No.) |
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(IRS Employer Identification No.) |
9393 Towne Centre Drive, Suite 200
San Diego, California 92121
(Address of principal executive offices and zip code)
Registrants telephone number, including area code: (858) 332-3410
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 (see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02 Results of Operations and Financial Condition.
On August 4, 2016, Mirati Therapeutics, Inc. issued a press release announcing its financial results for the second quarter ended June 30, 2016. A copy of this press release is attached hereto as Exhibit 99.1.
The information in this Item 2.02 and the exhibit hereto are being furnished and shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liability of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
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Description |
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99.1 |
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Press Release dated August 4, 2016 |
SIGNATURES
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.
Date: August 4, 2016 |
MIRATI THERAPEUTICS, INC. | |
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By: |
/s/ Jamie A. Donadio |
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Jamie A. Donadio |
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Senior Vice President and Chief Financial Officer |
Exhibit 99.1
MIRATI THERAPEUTICS REPORTS FINANCIAL RESULTS AND PROVIDES
BUSINESS UPDATE FOR THE SECOND QUARTER 2016
SAN DIEGO August 4, 2016 Mirati Therapeutics, Inc. (NASDAQ: MRTX) (the Company or Mirati) today reported financial results for the second quarter ended June 30, 2016 and provided an update on its product development programs.
We reported progress across our pipeline during the second quarter, including clinical responses in patients treated with glesatinib and sitravatinib. We have since treated a number of patients with the new spray-dried dispersion formulation of glesatinib and have observed improved tolerability compared to the original formulation, said Charles M. Baum, M.D., Ph.D., President and CEO of Mirati. Confirming responses to this formulation is our highest priority. We are encouraged by enrollment rates in this clinical trial as well as our other trials, and will provide efficacy updates for all of our programs as they progress.
Current Programs
Glesatinib (MGCD265)
The Phase 2 clinical trial in non-small cell lung cancer (NSCLC) patients with MET genetic alterations is currently enrolling patients on the new spray-dried dispersion (SDD) formulation of glesatinib. Enrollment rates in the trial continue to increase, due in part to the Companys diagnostic partnerships. These have significantly increased the ability to identify and enroll patients and have further confirmed that approximately seven percent of NSCLC patients express the mutations of interest. To date, the SDD formulation is demonstrating improved tolerability. An update will be provided once data is collected on at least 15 patients.
Sitravatinib (MGCD516)
The Phase 1b clinical trial of sitravatinib continues to enroll patients with RET, CHR4q12 and CBL genetic alterations in NSCLC and other solid tumors. Patient enrollment is on track, and updates will be provided on the status of this clinical trial as we receive more data.
Mocetinostat (MGCD103)
The Phase 2 clinical trial for mocetinostat in combination with durvalumab, MedImmunes investigational anti-PD-L1 immune checkpoint inhibitor, was initiated in June 2016 and is progressing as planned. The clinical trial is exploring the potential of mocetinostat to enhance the effectiveness of checkpoint inhibitors in NSCLC and other solid tumors.
Second Quarter and First Half 2016 Financial Results
Cash, cash equivalents, and short-term investments were $91.3 million at June 30, 2016, compared to $122.3 million at December 31, 2015.
Research and development expenses for the second quarter of 2016 were $18.4 million, compared to $11.3 million for the same period in 2015. Research and development expenses for the six months ended June 30, 2016 were $36.4 million compared to $19.5 million for the same period in 2015. The increase in research and development expenses for both the three and six months ended June 30, 2016 primarily relates to an increase in expenses associated with ongoing clinical trials, primarily for glesatinib, as well as an increase in other research and development expenses, which reflects both higher compensation costs due to an increase in research and development employees during the three and six months ended June 30, 2016 compared to the same period of 2015, as well as a one-time license fee of $2.5 million related to an early stage discovery project.
General and administrative expenses for the second quarter of 2016 were $3.8 million, compared to $4.2 million for the same period in 2015. General and administrative expenses for the six months ended June 30, 2016 were $7.9 million compared to $8.0 million for the same period of 2015. The decrease in general and administrative expense for the second quarter primarily reflects a decrease in employee-related expense, which was primarily due to a reversal of non-cash stock-based compensation expense associated with unvested stock options granted to our former Chief Operations Officer, partially offset by a non-recurring severance charge associated with his resignation.
Net loss for the second quarter of 2016 was $22.0 million, or $1.11 per share, compared to net loss of $15.5 million, or $0.95 per share, for the same period in 2015. Net loss for the six months ended June 30, 2016 was $44.0 million, or $2.24 per share, compared to $27.4 million, or $1.74 per share, for the same period of 2015.
About Mirati Therapeutics
Mirati Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing a pipeline of targeted oncology products intended to treat specific genetic and epigenetic drivers of cancer in selected subsets of cancer patients with unmet needs. In addition, our product candidates will be evaluated in combination with checkpoint inhibitors (anti-PD1 and PD-L1) to determine whether they will enhance the efficacy of those agents in patients with non-small cell lung cancer (NSCLC) and other solid tumors. Our clinical pipeline consists of three product candidates: glesatinib, sitravatinib and mocetinostat. Both glesatinib and sitravatinib are orally bio-available, spectrum-selective kinase inhibitors with distinct target profiles that are in development for the treatment of patients with NSCLC and other solid tumors. Glesatinib is in Phase 2 clinical development, and targets the MET and Axl receptor tyrosine kinase families. Sitravatinib is in Phase 1b clinical development and targets genetic alterations in the RET rearrangements, CHR4q12 amplifications, and CBL mutations. Our third product candidate is mocetinostat, an orally bio-available, Class 1 selective histone deacetylase inhibitor. Mocetinostat is in Phase 2 clinical development in combination with durvalumab, MedImmunes anti-PD-L1 immune checkpoint inhibitor, for the treatment of patients with NSCLC. More information is available at www.mirati.com.
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Contacts:
Marcy Graham
Mirati Therapeutics Inc.
Vice President, Investor Relations and Corporate Communications
(858) 332-3557
grahamm@mirati.com
Jesse Baumgartner
Stern Investor Relations
Senior Associate
(212) 362-1200
jesse@sternir.com
Forward Looking Statements
Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, contain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve significant risks and uncertainties. For more detailed disclosures and discussions regarding such forward looking statements, please refer to Miratis filings with the U.S. Securities and Exchange Commission (SEC), including without limitation Miratis filings on Forms 10-K, 10-Q, and 8-K. Forward looking statements are based on the current expectations of management and upon what management believes to be reasonable assumptions based on information currently available to it. Such statements can usually be identified by the use of words such as may, would, believe, intend, plan, anticipate, estimate, expect, and other similar terminology, or by statements that certain actions, events or results may or would be taken, occur or be achieved. Such statements include, but are not limited to, statements regarding Miratis development plans and timelines, potential regulatory actions, expected use of cash resources, the timing and results of clinical trials, and the potential benefits of and markets for Miratis product candidates. Forward looking statements involve significant risks and uncertainties and are neither a prediction nor a guarantee that future events or circumstances will occur. Such risks include, but are not limited to, potential delays in development timelines or negative clinical trial results, reliance on third parties for development efforts, changes in the competitive landscape, changes in the standard of care, as well as other risks described in Miratis filings with the SEC. We are including this cautionary note to make applicable, and to take advantage of, the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The information in this news release is given as of the date above and Mirati expressly disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law.
Mirati Therapeutics, Inc.
Consolidated Balance Sheets
(in thousands)
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June 30, |
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December 31, |
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2016 |
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2015 |
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(unaudited) |
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Assets |
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Current assets |
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Cash, cash equivalents and short-term investments |
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$ |
91,313 |
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$ |
122,327 |
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Other current assets |
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1,726 |
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3,075 |
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Total current assets |
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93,039 |
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125,402 |
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Property and equipment, net |
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558 |
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614 |
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Other assets |
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2,396 |
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2,001 |
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Total assets |
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$ |
95,993 |
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$ |
128,017 |
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Liabilities and Stockholders Equity |
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Current liabilities |
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Accounts payable and accrued liabilities |
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$ |
13,790 |
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$ |
9,798 |
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Total current liabilities |
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13,790 |
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9,798 |
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Other liability |
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24 |
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43 |
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Total liabilities |
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13,814 |
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9,841 |
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Stockholders equity |
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82,179 |
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118,176 |
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Total liabilities and stockholders equity |
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$ |
95,993 |
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$ |
128,017 |
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Mirati Therapeutics, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands except per share data, unaudited)
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Three months ended |
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Six months ended |
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June 30, |
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June 30, |
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2016 |
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2015 |
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2016 |
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2015 |
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Expenses |
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Research and development |
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$ |
18,441 |
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$ |
11,276 |
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$ |
36,429 |
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$ |
19,483 |
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General and administrative |
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3,786 |
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4,240 |
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7,916 |
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8,019 |
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Total operating expenses |
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22,227 |
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15,516 |
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44,345 |
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27,502 |
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Loss from operations |
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(22,227 |
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(15,516 |
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(44,345 |
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(27,502 |
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Other income, net |
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166 |
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70 |
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370 |
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116 |
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Net loss |
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$ |
(22,061 |
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$ |
(15,446 |
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$ |
(43,975 |
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$ |
(27,386 |
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Unrealized gain (loss) on available-for-sale investments |
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33 |
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(9 |
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60 |
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(4 |
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Comprehensive loss |
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$ |
(22,028 |
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$ |
(15,455 |
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$ |
(43,915 |
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$ |
(27,390 |
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Basic and diluted net loss per share |
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$ |
(1.11 |
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$ |
(0.95 |
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$ |
(2.24 |
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$ |
(1.74 |
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Weighted average number of shares used in computing net loss per share, basic and diluted |
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19,912,938 |
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16,235,261 |
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19,646,889 |
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15,727,891 |
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