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Mirati Therapeutics, Inc.® (NASDAQ: MRTX) Announces Positive Third Quarter 2023 Results and Provides Pipeline and Corporate Updates

SAN DIEGO, Nov. 6, 2023 /PRNewswire/ — Mirati Therapeutics, Inc.┬«, a leading biotechnology company, reported its financial results for the third quarter of 2023, along with significant updates on its pipeline and corporate developments.

Significant Progress in the Third Quarter:

Mirati Therapeutics, Inc. saw significant progress in the third quarter of 2023, particularly with the advancement of its robust pipeline of targeted oncology programs and continued launch execution of its flagship therapy, KRAZATI®. According to Charles Baum, M.D., Ph.D., CEO, president, and founder of Mirati Therapeutics, Inc., the company believes that its pending acquisition by Bristol Myers Squibb will support the realization of the full potential of their therapies and enable the promise of a life beyond cancer. The company remains committed to improving the lives of people with cancer through the discovery and development of innovative therapeutics.

Updates on the Pipeline:

Adagrasib (Potent and selective KRASG12C inhibitor):

In November, the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) granted conditional marketing authorization approval for KRAZATI (adagrasib) as a monotherapy indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRASG12C mutation and progressive disease after prior therapy with platinum-based chemotherapy and/or anti-PD-1/PD-L1 immunotherapy.

In October, updated results from the KRYSTAL-7 Phase 2 study evaluating adagrasib combined with pembrolizumab in patients with first-line NSCLC with a KRASG12C mutation were presented at the European Society of Medical Oncology Congress (ESMO) 2023.

In September, two-year follow-up data from a pooled analysis of the Phase 1/1b Cohort and Phase 2 Cohort A for the KRYSTAL-1 study evaluating adagrasib in NSCLC patients harboring a KRASG12C mutation were presented at the 2023 World Conference on Lung Cancer (WCLC).

The National Comprehensive Cancer Network (NCCN) Guidelines for Colon and Rectal Cancer now include adagrasib for patients harboring a KRASG12C mutation. The Company completed enrollment in KRYSTAL-10, a Phase 3 registrational clinical study in second-line colorectal cancer patients with a KRASG12C mutation, evaluating the combination of adagrasib plus cetuximab versus chemotherapy. Enrollment is ongoing in KRYSTAL-12, a Phase 3 clinical study of adagrasib versus docetaxel in second-line NSCLC patients. Re-examination by the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) of the Conditional Marketing Authorisation Application (MAA) for KRAZATI (adagrasib) for the treatment of patients with KRASG12C-mutated advanced NSCLC is currently underway.

MRTX1719 (MTA cooperative PRMT5 inhibitor):

In August, initial clinical data in patients with MTAP-deleted cancers were shared. The Phase 1/2 clinical study is ongoing, and patients continue to be enrolled.

MRTX1133 (Potent and selective KRASG12D inhibitor):

The Phase 1/2 clinical study is ongoing, and patients continue to be enrolled.

MRTX0902 (Potent SOS1 inhibitor):

The Phase 1/2 clinical study evaluating the combination of MRTX0902 plus adagrasib is continuing to advance.

Recent Corporate Updates:

In October, Mirati Therapeutics, Inc. and Bristol Myers Squibb announced their entry into a merger agreement, under which Bristol Myers Squibb will acquire Mirati for $58.00 per share in cash, for a total equity value of $4.8 billion. Mirati stockholders will also receive one non-tradeable Contingent Value Right (CVR) for each Mirati share held, potentially worth $12.00 per share in cash, representing an additional $1.0 billion of value opportunity. The transaction is expected to close by the first half of 2024, subject to fulfillment of customary closing conditions, including approval of the Company’s stockholders and receipt of the required regulatory approvals.

In August, Mirati Therapeutics, Inc. executed an underwritten public offering.

Third Quarter Financial Results:

As of September 30, 2023, Mirati Therapeutics, Inc. had cash, cash equivalents, and short-term investments of approximately $976.4 million. This includes proceeds from an August 2023 public offering of their common stock that generated net proceeds of $332.5 million. Excluding the August 2023 financing, the net decrease in cash, cash equivalents, and short-term investments for the third quarter of 2023 was $135.5 million.

Net KRAZATI product revenue for the three and nine months ended September 30, 2023, was $16.4 million and $36.1 million, respectively. This includes commercial sales and sales to a third-party commercial customer for its clinical trials. There was no product revenue for the same periods in 2022.

License and collaboration revenue for the three and nine months ended September 30, 2023, was zero and $1.2 million, respectively, related to clinical supply revenue earned under the agreement with Zai Lab. License and collaboration revenue for the same periods in 2022 was $5.4 million and $11.5 million, respectively, related to milestone payments from Zai Lab and clinical supply revenue earned under the agreement with Zai Lab.

Cost of product revenue for the three and nine months ended September 30, 2023, was $1.7 million and $3.8 million, respectively, including product manufacturing and distribution costs and royalties incurred on net sales of KRAZATI®. There was no cost of product revenue for the same periods in 2022.

Research and development expenses for the three and nine months ended September 30, 2023, were $114.8 million and $365.6 million, respectively, compared to $131.1 million and $390.4 million for the same periods in 2022, respectively. The decrease was mainly due to reduced clinical development costs for sitravatinib and a decrease in share-based compensation, partially offset by increases in costs for earlier stage clinical development programs such as MRTX1133.

Selling, general, and administrative expenses for the three and nine months ended September 30, 2023, were $72.0 million and $221.0 million, respectively, compared to $60.8 million and $169.0 million, respectively, for the same periods in 2022. The increases were primarily due to increased headcount-related costs, including share-based compensation, and commercial-related costs to support the marketing and sales of KRAZATI®.

Net loss for the three months ended September 30, 2023, was $161.9 million, or $2.49 per share basic and diluted, compared to a net loss of $173.6 million, or $3.09 per share basic and diluted for the same period in 2022. Net loss for the nine months ended September 30, 2023, was $523.4 million, or $8.66 per share basic and diluted, compared to a net loss of $538.4 million, or $9.66 per share basic and diluted for the same period in 2022.

Mirati Therapeutics, Inc. Overview:

Mirati Therapeutics, Inc. is a commercial stage biotechnology company committed to discovering, designing, and delivering breakthrough therapies to transform the lives of cancer patients and their loved ones. The company focuses on areas of high unmet need, including lung cancer, and is dedicated to advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. With a vision to unlock the science behind the promise of a life beyond cancer, Mirati Therapeutics, Inc. is united in its mission to provide innovative treatment options for patients.

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