0001628280-22-020587.txt : 20220803 0001628280-22-020587.hdr.sgml : 20220803 20220803160423 ACCESSION NUMBER: 0001628280-22-020587 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20220803 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220803 DATE AS OF CHANGE: 20220803 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Mirati Therapeutics, Inc. CENTRAL INDEX KEY: 0001576263 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 462693615 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-35921 FILM NUMBER: 221132487 BUSINESS ADDRESS: STREET 1: 3545 CRAY COURT CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 858-332-3410 MAIL ADDRESS: STREET 1: 3545 CRAY COURT CITY: SAN DIEGO STATE: CA ZIP: 92121 8-K 1 mrtx-20220803.htm 8-K mrtx-20220803
0001576263false00015762632022-08-032022-08-03

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 3, 2022
  
MIRATI THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
 
Delaware 001-35921 46-2693615
(State of incorporation) (Commission File No.) (IRS Employer Identification No.)

3545 Cray Court, San Diego, California 92121
(Address of principal executive offices and zip code)
Registrant’s 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):
 
☐    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))
 
Securities registered pursuant to Section 12(b) of the Act:
Title of Each ClassTrading SymbolName of Each Exchange on Which Registered
Common StockMRTXThe Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
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 2.02Results of Operations and Financial Condition.

    On August 3, 2022, Mirati Therapeutics, Inc. issued a press release announcing its financial results for the three and six months ended June 30, 2022. 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 9.01Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
  
99.1 
104Cover Page Interactive Data File (embedded within the Inline XBRL document)



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.
 
    
 Mirati Therapeutics, Inc.
  
Date: August 03, 2022 By:/s/ Reena R. Desai
   Reena R. Desai
   Chief Legal Officer and Corporate Secretary

 EX-99.1 2 exhibit991-q22022.htm EX-99.1 Document



miratilogo2020a.jpg
Mirati Therapeutics Reports Second Quarter 2022 Financial Results and Recent Corporate Updates

SAN DIEGO – August 3, 2022 – Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, today reported financial results for the second quarter of 2022 and recent corporate updates.
“Mirati continues to advance the development of a broad portfolio of targeted oncology medicines,” said David Meek, chief executive officer, Mirati Therapeutics, Inc. “We are progressing toward the potential launch of adagrasib for patients with previously treated non-small cell lung cancer harboring a KRASG12C mutation in the U.S. this year. In addition, we have submitted a Marketing Authorization Application to the European Medicines Agency, bringing us one step closer to expanding the potential availability of adagrasib in the European Union. We continue to progress our sitravatinib and MRTX0902 clinical programs, which strengthen our targeted oncology portfolio. Our financial position remains strong, enabling continued investment and advancement of our extensive oncology pipeline.”
Pipeline Updates
Adagrasib (Potent and selective KRASG12C inhibitor)
•Presented full results from the registration-enabling Phase 2 cohort of the KRYSTAL-1 study evaluating adagrasib in patients with previously treated non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. These results were published concurrently in the New England Journal of Medicine.

•Presented late-breaking data on adagrasib in patients with KRASG12C-mutated NSCLC with active and untreated central nervous system (CNS) metastases at the 2022 ASCO Annual Meeting.

•Submitted a Marketing Authorization Application to the European Medicines Agency for adagrasib for the treatment of patients with previously treated NSCLC harboring a KRASG12C mutation.
Sitravatinib (Potent TAM receptor inhibitor)
•Anticipated to achieve the number of events needed to trigger an interim analysis of overall survival in the global, registrational Phase 3 SAPPHIRE study evaluating sitravatinib plus nivolumab (OPDIVO®)1 in second or third line non-squamous NSCLC in the fourth quarter of 2022.
MRTX0902 (Potent SOS1 inhibitor)
•Submitted an Investigational New Drug (IND) application to the U.S. FDA to evaluate MRTX0902, a selective SOS1 inhibitor, which shifts KRAS into its inactivated state resulting in significantly increased activity of adagrasib and other KRAS inhibitors in preclinical models and may improve clinical efficacy of adagrasib in patients with KRAS G12C mutations. The Company expects to initiate a Phase 1/2 clinical study by year-end 2022.
Recent Corporate Updates
•Announced the appointment of Laurie Stelzer as Chief Financial Officer.
1


Second Quarter 2022 Financial Results
•Cash, cash equivalents, and short-term investments of approximately $1.2 billion as of June 30, 2022
•Research and development expenses for the second quarter 2022 were $128.3 million, compared to $134.6 million for the same period in 2021. The decrease was primarily related to a decrease in manufacturing costs that occurred after our 2021 NDA filing for the adagrasib program, offset by increases in headcount-related costs, including share-based compensation, due to increased headcount associated with the growth of our portfolio. Research and development expenses for the six months ended June 30, 2022 were $259.3 million, compared to $238.6 million for the same period in 2021. The increase was primarily related to increases in headcount-related costs, including share-based compensation, due to increased headcount associated with the growth of our portfolio, offset by a decrease in manufacturing costs that occurred after our 2021 NDA filing for the adagrasib program. The Company recognized research and development-related share-based compensation expenses of $22.8 million during the second quarter of 2022, compared to $16.5 million for the same period in 2021, and $49.1 million during the six months ended June 30, 2022, compared to $31.0 million for the same period in 2021.

•General and administrative expenses for the second quarter of 2022 were $54.2 million, compared to $29.6 million for the same period in 2021. General and administrative expenses for the six months ended June 30, 2022 were $108.2 million, compared to $58.0 million for the same period in 2021. The increases were primarily due to an increase in commercial readiness costs, including increases in headcount-related costs, as we prepare for a potential product launch. The Company recognized general and administrative-related share-based compensation expenses of $15.9 million in the second quarter of 2022, compared to $11.5 million for the same period in 2021, and $32.5 million during the six months ended June 30, 2022, compared to $21.7 million for the same period in 2021.
•Net loss for the second quarter of 2022 was $176.4 million, or $3.18 per share basic and diluted, compared to a net loss of $166.4 million, or $3.23 per share basic and diluted for the same period in 2021. Net loss for the six months ended June 30, 2022 was $364.8 million, or $6.57 per share basic and diluted, compared to a net loss of $302.1 million, or $5.91 per share basic and diluted for the same period in 2021.
Conference Call Information
There will be a conference call on August 3, 2022 at 4:30 p.m. ET / 1:30 p.m. PT during which company executives will review financial information for the second quarter of 2022 and provide corporate updates.

Investors and the general public are invited to listen to a live webcast of the call at the “Investors and Media” section on Mirati.com or by dialing the U.S. toll free +1 313-209-4906 or international +1 877-502-9276, confirmation code: 1791105.
A replay of the call will be available approximately 2 hours after the event has ended at the same website.
About Mirati Therapeutics, Inc.
Mirati Therapeutics, Inc. is a clinical-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Unified for patients, Mirati’s vision is to unlock the science behind the promise of a life beyond cancer. For more information about Mirati, visit us at Mirati.com or follow us on Twitter, LinkedIn and Facebook.
2


Forward Looking Statements
This press release contains forward-looking statements regarding the business of Mirati Therapeutics, Inc. (“Mirati”). Any statement describing Mirati’s goals, expectations, financial or other projections, intentions or beliefs, development plans and the commercial potential of Mirati’s drug development pipeline, including without limitation adagrasib (selective KRASG12C inhibitor), sitravatinib (TAM receptor inhibitor), MRTX1719 (MTA cooperative PRMT5 inhibitor), MRTX0902 (SOS1 inhibitor), and MRTX1133 (selective KRASG12D inhibitor), is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to risks and uncertainties, particularly those challenges inherent in the process of discovering, developing and commercialization of new drug products that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.
Mirati’s forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Mirati’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Mirati. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Mirati’s programs are described in additional detail in Mirati’s quarterly reports on Form 10-Q and annual reports on Form 10-K, which are on file with the U.S. Securities and Exchange Commission (the “SEC”) available at the SEC’s Internet site (www.sec.gov). Mirati assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.
Mirati Contacts
Investor Relations: ir@mirati.com
Media Relations: media@mirati.com
+++
1OPDIVO® (nivolumab) is a registered trademark of Bristol Myers Squibb
3


Mirati Therapeutics, Inc.
Consolidated Balance Sheets
(in thousands)
June 30,December 31,
 20222021
Assets 
Current assets  
Cash, cash equivalents and short-term investments$1,181,328 $1,491,340 
Other current assets21,598 16,643 
Total current assets1,202,926 1,507,983 
Property and equipment, net17,163 15,824 
Long-term investment2,635 8,218 
Right-of-use asset36,823 37,680 
Other long-term assets20,243 19,049 
Total assets$1,279,790 $1,588,754 
Liabilities and Shareholders' Equity  
Current liabilities  
Accounts payable$24,269 $35,163 
Accrued liabilities94,878 108,495 
Total current liabilities119,147 143,658 
Lease liability45,823 45,879 
Other liabilities2,816 2,179 
Total liabilities167,786 191,716 
Shareholders’ equity1,112,004 1,397,038 
Total liabilities and shareholders’ equity$1,279,790 $1,588,754 

4


Mirati Therapeutics, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands)

 
Three Months Ended
June 30,
Six Months Ended
June 30,
 2022202120222021
(unaudited)(unaudited)
Revenue  
License and collaboration revenues$5,362 $— $6,071 $— 
Total revenue5,362 — 6,071 — 
Expenses    
Research and development128,339 134,575 259,315 238,646 
General and administrative54,228 29,611 108,179 57,961 
Total operating expenses182,567 164,186 367,494 296,607 
Loss from operations(177,205)(164,186)(361,423)(296,607)
Other income (expense), net760 (2,244)(3,408)(5,503)
Net loss$(176,445)$(166,430)$(364,831)$(302,110)
Unrealized (loss) gain on available-for-sale investments(909)145 (5,711)(158)
Comprehensive loss$(177,354)$(166,285)$(370,542)$(302,268)
Net loss per share, basic and diluted$(3.18)$(3.23)$(6.57)$(5.91)
Weighted average common shares outstanding, basic and diluted55,55251,47355,51151,128


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Cover Page
Aug. 03, 2022
Entity Addresses [Line Items]  
Entity Central Index Key 0001576263
Amendment Flag false
Document Type 8-K
Document Period End Date Aug. 03, 2022
Entity Registrant Name MIRATI THERAPEUTICS, INC.
Entity Incorporation, State or Country Code DE
Entity File Number 001-35921
Entity Tax Identification Number 46-2693615
Entity Address, Address Line One 3545 Cray Court
Entity Address, City or Town San Diego
Entity Address, State or Province CA
Entity Address, Postal Zip Code 92121
City Area Code 858
Local Phone Number 332-3410
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company false
Title of 12(b) Security Common Stock
Trading Symbol MRTX
Security Exchange Name NASDAQ
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