# EDGAR Filing Document

**Accession Number:** 0001576263
**File Stem:** 0001628280-23-005543
**Filing Date:** 2023-2
**Character Count:** 21709
**Document Hash:** 6e47d2f700ca91f26c132151a5c129a0
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001628280-23-005543.hdr.sgml**: 20230228

**ACCESSION NUMBER**: 0001628280-23-005543

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20230228

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230228

**DATE AS OF CHANGE**: 20230228

**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:** 23685220

**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

?xml version="1.0" ? mrtx-20230228

    

**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): February 28, 2023

**MIRATI THERAPEUTICS, INC.** 

(Exact name of registrant as specified in its charter)

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| | | |
|:---|:---|:---|
| **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):

☐&nbsp;&nbsp;&nbsp;&nbsp;Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐&nbsp;&nbsp;&nbsp;&nbsp;Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐&nbsp;&nbsp;&nbsp;&nbsp;Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐&nbsp;&nbsp;&nbsp;&nbsp;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:

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| | | |
|:---|:---|:---|
| **<u>Title of Each Class</u>** | **<u>Trading Symbol</u>** | **<u>Name of Each Exchange on Which Registered</u>** |
| **Common Stock** | **MRTX** | **The Nasdaq Global Select Market** |

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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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| | |
|:---|:---|
| **Item 2.02** | **Results of Operations and Financial Condition.** |

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&nbsp;&nbsp;&nbsp;&nbsp;On February 28, 2023, Mirati Therapeutics, Inc. issued a press release announcing its financial results for the three and twelve months ended December 31, 2022. A copy of this press release is attached hereto as Exhibit 99.1.

&nbsp;&nbsp;&nbsp;&nbsp;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.

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| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.** |

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**(d) Exhibits.**

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| | |
|:---|:---|
| **Exhibit No.** | **<u>Description</u>** |
| 99.1 | <u>[Press Release dated February 28, 2023](exhibit991-q42022.htm)</u> |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

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**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.

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| | | |
|:---|:---|:---|
| | **Mirati Therapeutics, Inc.** | **Mirati Therapeutics, Inc.** |
| Date: February 28, 2023 | By: | /s/ Reena R. Desai |
|  |  | Reena R. Desai |
|  |  | Chief Legal Officer and Corporate Secretary |

---

## Exhibit 99.1

![miratilogo2020.jpg](miratilogo2020.jpg)

**Mirati Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Corporate Updates**

SAN DIEGO – February 28, 2023 – Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, today announced financial results for the fourth quarter and full year of 2022 along with recent corporate updates.

"2022 was a momentous year for Mirati, culminating in the approval and launch of KRAZATI™ as a treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS<sup>G12C</sup> mutation. We believe this is the first of several potentially best-in-class products on the horizon for Mirati," said David Meek, chief executive officer, Mirati Therapeutics, Inc. "In addition to the approval of KRAZATI™ in 2022 we advanced MRTX1719 and MRTX0902 into clinical trials and filed an Investigational New Drug application for MRTX1133. These accomplishments bring us closer to realizing our vision to unlock the promise of a life beyond cancer. We look ahead to 2023 with excitement as the company enters a new phase of commercialization from a strong financial position."

**Pipeline Updates**

*Adagrasib (Potent and selective KRAS*<sup>G12C</sup> *inhibitor)* 

• In December 2022, the Company announced the U.S. Food and Drug Administration (FDA) granted accelerated approval of KRAZATI™ (*adagrasib*), a targeted treatment option for adult patients with KRAS<sup>G12C</sup>-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy.

• In December 2022, the Company announced the FDA granted Breakthrough Therapy Designation (BTD) for *adagrasib* in combination with cetuximab in patients with KRAS<sup>G12C</sup>-mutated advanced colorectal cancer (CRC) whose cancer has progressed following prior treatment with chemotherapy and an anti-VEGF therapy. The *New England Journal of Medicine* published these findings, which demonstrate promising clinical activity and a favorable tolerability profile. Based on recent FDA discussions, the Company expects to move forward with an application for Accelerated Approval in third-line or later KRAS<sup>G12C</sup>-mutated advanced CRC.

• In December 2022, the Company announced preliminary results from the KRYSTAL-7 Phase 2 study and KRYSTAL-1 Phase 1b cohort evaluating *adagrasib* concurrently combined with pembrolizumab in patients for the treatment of first-line NSCLC harboring a KRAS<sup>G12C</sup> mutation at the 2022 European Society for Medical Oncology (ESMO) Immuno-Oncology Annual Congress. The data demonstrated the combinability of KRAZATI™ with pembrolizumab as well as initial promising clinical activity.

• In November 2022, the Company announced a clinical study collaboration and supply agreement with Incyte to evaluate the combination of *adagrasib* and INCB099280, an oral PD1 inhibitor, in patients with KRAS<sup>G12C</sup>-mutant solid tumors.

• In October 2022, the Company announced a clinical collaboration with Aadi Bioscience to evaluate the combination of *adagrasib* and *nab*-sirolimus, an mTOR inhibitor complexed with human albumin, in KRAS<sup>G12C</sup>-mutant NSCLC and other solid tumors.

------

*Sitravatinib (Potent TAM receptor inhibitor)*

• The Company expects to provide topline final overall survival results from the global, registration-enabling Phase 3 SAPPHIRE study evaluating *sitravatinib* plus nivolumab (OPDIVO<sup>®</sup>)<sup>1</sup> in second or third line non-squamous NSCLC in the second quarter of 2023.

*MRTX1719 (MTA cooperative PRMT5 inhibitor)*

• A Phase 1/2 clinical study to evaluate MRTX1719, an MTA cooperative PRMT5 inhibitor, in patients with solid tumors harboring MTAP-gene deletions is ongoing. The study continues to enroll, and the Company expects to share the initial clinical data in the second half of 2023.

*MRTX0902 (Potent SOS1 inhibitor)* 

• The Company initiated a Phase 1/2 clinical study initially evaluating MRTX0902, a selective KRAS signal modifying SOS1 inhibitor, in an escalating dose cohort as a monotherapy and expects to initiate dose escalation cohorts combining MRTX0902 and *adagrasib* in the second half of 2023.

*MRTX1133 (Potent and selective KRAS*<sup>G12D</sup> *inhibitor)* 

• In December 2022, the Company submitted the IND application for MRTX1133, a potent and selective KRAS<sup>G12D</sup> inhibitor, which was cleared by the FDA in January 2023. The Company initiated a Phase 1/2 clinical study in February 2023 with plans for multiple expansion cohorts in pancreatic, colorectal, lung and other tumor types with KRAS<sup>G12D</sup> mutations.

**Recent Corporate Updates**

• In November 2022, the Company announced the appointment of Alan Sandler, M.D., as Chief Medical Officer and the planned retirement of Charles Baum, M.D., Ph.D., president, founder and head of research and development in the second quarter of 2023.

• The Company published the 2022 Corporate Sustainability Report, the Company's second annual report, which provides information describing investments and resources based on the biotechnology and pharmaceuticals framework of the Sustainability Accounting Standards Board.

**Fourth Quarter and Full-Year 2022 Financial Results**

• Cash, cash equivalents, and short-term investments of approximately $1.1 billion as of December 31, 2022.

• Net product revenue for both the fourth quarter 2022 and the twelve months ended December 31, 2022 was $0.7 million and was driven by sales of KRAZATI™, which received approval by the FDA and launched commercially in the U.S. in December 2022. There was no product revenue for the same periods in 2021.

• License and collaboration revenue for the fourth quarter 2022 was $0.2 million, compared to $0.3 million for the same period in 2021. License and collaboration revenues for the twelve months ended December 31, 2022 were $11.7 million, primarily driven by milestone payments received from Zai Lab in connection with the initiation of pivotal clinical studies of *adagrasib* for the first and second indications in the Zai Lab designated territories during 2022. This compares to license and collaboration revenues of $72.1 million for the same period in 2021, primarily driven by $66.6 million of revenue associated with the transfer of the license and know-how of *adagrasib* as part of our agreement with Zai

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Lab, and a $5.0 million milestone payment from BeiGene, associated with the start of the first pivotal *sitravatinib* clinical study in the BeiGene designated territories.

• Cost of product revenue for both the fourth quarter 2022 and the twelve months ended December 31, 2022 was $0.6 million and was primarily due to non-recurring, launch-related product distribution costs for KRAZATI™ following FDA approval in December 2022. There was no cost of product revenue for the same periods in 2021.

*•* Research and development expenses for the fourth quarter 2022 were $141.2 million, compared to $153.8 million for the same period in 2021. Research and development expenses for the twelve months ended December 31, 2022 were $531.6 million, compared to $508.6 million for the same period in 2021. The decrease in research and development expenses for the fourth quarter 2022 compared to the same period in 2021 was primarily due to the manufacturing costs incurred in 2021 to support our New Drug Application (NDA) and commercial launch, partially offset by an increase in headcount-related costs, including share-based compensation and salaries, due to the growth of our headcount to support our growing portfolio. The increase in research and development expenses for the twelve months ended December 31, 2022 compared to the same period in 2021 was primarily driven by an increase in development costs to advance our preclinical and clinical development programs, and an increase in headcount-related costs, including share-based compensation and salaries, offset primarily by a reduction in manufacturing costs for *adagrasib* to support our NDA and commercial launch. The Company recognized research and development-related share-based compensation expenses of $36.2 million during the fourth quarter 2022, compared to $21.8 million for the same period in 2021, and $113.5 million during the twelve months ended December 31, 2022, compared to $68.5 million for the same period in 2021.

*•* Selling, general and administrative expenses for the fourth quarter 2022 were $70.8 million, compared to $43.5 million for the same period in 2021. Selling, general and administrative expenses for the twelve months ended December 31, 2022 were $239.8 million, compared to $136.7 million for the same period in 2021. The increases were primarily due to an increase in headcount-related costs, including share-based compensation and salaries, and commercial readiness costs as we prepared for the commercial launch of KRAZATI™. The Company recognized selling, general and administrative-related share-based compensation expenses of $25.4 million in the fourth quarter 2022, compared to $12.1 million for the same period in 2021, and $72.6 million during the twelve months ended December 31, 2022, compared to $45.0 million for the same period in 2021.

• Net loss for the fourth quarter 2022 was $202.5 million, or $3.51 per share basic and diluted, compared to a net loss of $199.6 million, or $3.72 per share basic and diluted for the same period in 2021. Net loss for the twelve months ended December 31, 2022 was $740.9 million, or $13.18 per share basic and diluted, compared to a net loss of $581.8 million, or $11.21 per share basic and diluted for the same period in 2021.

**Conference Call Information** 

There will be a conference call on February 28, 2023 at 4:30 p.m. ET / 1:30 p.m. PT during which company executives will review financial information for the fourth quarter and full year 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 +1 773-305-6853 or international +1 888-394-8218, confirmation code: 2312901.

A replay of the call will be available approximately 2 hours after the event has ended at the same website.

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**About Mirati Therapeutics, Inc.**

Mirati Therapeutics, Inc. is a commercial 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.

**Forward Looking Statements**

This press release includes forward-looking statements regarding Mirati's business, financial guidance and the therapeutic and commercial potential of KRAZATI™ (*adagrasib*), *sitravatinib* (TAM receptor inhibitor), MRTX1719 (MTA-cooperative PRMT5 inhibitor), MRTX0902 (SOS1 inhibitor), and MRTX1133 (selective KRAS<sup>G12D</sup> inhibitor), Mirati's technologies and Mirati's other products in development. Any statement describing Mirati's goals, expectations, intentions or beliefs, financial or other projections, is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including those related to the impact COVID-19 could have on our business, and including those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines.

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 annual report on Form 10-K, and most recent Form 10-Q, which are on file with the Securities and Exchange Commission and available at the SEC's Internet site (www.sec.gov). These forward-looking statements are made as of the date of this press release, and 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

+++

<sup>1</sup>OPDIVO<sup>®</sup> (nivolumab) and the related logo are registered trademarks of Bristol-Myers Squibb Company

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**Mirati Therapeutics, Inc.**

**Consolidated Balance Sheets**

**(in thousands)**

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| | | |
|:---|:---|:---|
| | **December 31,**<br>**2022** | **December 31,**<br>**2021** |
| **Assets** |  |  |
| **Current assets** |  |  |
| &nbsp;&nbsp;&nbsp;Cash, cash equivalents and short-term investments | $1083837 | $1491340 |
| &nbsp;&nbsp;&nbsp;Accounts receivable, net | 865 |  |
| &nbsp;&nbsp;&nbsp;Inventory | 3020 |  |
| &nbsp;&nbsp;&nbsp;Other current assets | 21239 | 16643 |
| **Total current assets** | **1108961** | **1507983** |
| &nbsp;&nbsp;&nbsp;Property and equipment, net | 17540 | 15824 |
| &nbsp;&nbsp;&nbsp;Intangible asset, net | 14914 |  |
| &nbsp;&nbsp;&nbsp;Long-term investment | 3465 | 8218 |
| &nbsp;&nbsp;&nbsp;Right-of-use asset | 36122 | 37680 |
| &nbsp;&nbsp;&nbsp;Other long-term assets | 21645 | 19049 |
| **Total assets** | $**1202647** | $**1588754** |
| **Liabilities and Shareholders' Equity** |  |  |
| **Current liabilities** |  |  |
| &nbsp;&nbsp;&nbsp;Accounts payable | $38861 | $35163 |
| &nbsp;&nbsp;&nbsp;Accrued liabilities | 120587 | 108495 |
| **Total current liabilities** | **159448** | **143658** |
| &nbsp;&nbsp;&nbsp;Lease liability | 43661 | 45879 |
| &nbsp;&nbsp;&nbsp;Other liabilities | 3022 | 2179 |
| **Total liabilities** | **206131** | **191716** |
| **Shareholders' equity** | **996516** | **1397038** |
| **Total liabilities and shareholders' equity** | $**1202647** | $**1588754** |

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**Mirati Therapeutics, Inc.**

**Consolidated Statements of Operations and Comprehensive Loss**

**(in thousands)**

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| | | | | |
|:---|:---|:---|:---|:---|
| | **Three Months Ended**<br>**December 31,** | **Three Months Ended**<br>**December 31,** | **Twelve Months Ended**<br>**December 31,** | **Twelve Months Ended**<br>**December 31,** |
| | **2022** | **2021** | **2022** | **2021** |
| | (unaudited) | (unaudited) | | |
| **Revenue** |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Product revenue, net | $713 | $— | $713 | $— |
| &nbsp;&nbsp;&nbsp;License and collaboration revenues | 221 | 299 | 11723 | 72092 |
| **Total revenue** | **934** | **299** | **12436** | **72092** |
| **Expenses** |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Cost of product revenue | 600 |  | 600 |  |
| &nbsp;&nbsp;&nbsp;Research and development | 141236 | 153839 | 531627 | 508594 |
| &nbsp;&nbsp;&nbsp;Selling, general and administrative | 70821 | 43535 | 239798 | 136679 |
| **Total operating expenses** | **212657** | **197374** | **772025** | **645273** |
| **Loss from operations** | **(211723)** | **(197075)** | **(759589)** | **(573181)** |
| Other income (expense), net | 9502 | (2545) | 19230 | (5304) |
| **Loss before income taxes** | **(202221)** | **(199620)** | **(740359)** | **(578485)** |
| Income tax expense | 254 |  | 508 | 3299 |
| **Net loss** | $**(202475)** | $**(199620)** | $**(740867)** | $**(581784)** |
| Foreign currency translation adjustment | (78) |  | (9563) |  |
| Unrealized gain (loss) on available-for-sale investments | 2488 | (527) | (3224) | (691) |
| **Comprehensive loss** | $**(200065)** | $**(200147)** | $**(753654)** | $**(582475)** |
| Net loss per share, basic and diluted | $(3.51) | $(3.72) | $(13.18) | $(11.21) |
| Weighted average common shares outstanding, basic and diluted | 57672 | 53615 | 56232 | 51883 |

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