On November 6, 2023 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, reported financial results for the third quarter 2023 along with recent pipeline and corporate updates (Press release, Mirati, NOV 6, 2023, View Source [SID1234637038]).
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"We are pleased to share the significant progress made during the third quarter of 2023, highlighted by the advancement of our robust pipeline of targeted oncology programs and continued launch execution of KRAZATI," said Charles Baum, M.D., Ph.D., CEO, president and founder, Mirati Therapeutics, Inc. "As we shared last month, we believe our pending acquisition by Bristol Myers Squibb will support the realization of the full potential of our therapies and enable the promise of a life beyond cancer. We look forward to continuing our work to improve the lives of people with cancer through Mirati discovered and developed therapeutics."
Pipeline Updates
Adagrasib (Potent and selective KRASG12C inhibitor)
•In November, the Company announced 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 have progressive disease after prior therapy with, or intolerance to, platinum-based chemotherapy and/or anti-PD-1/PD-L1 immunotherapy.
•In October, the Company shared updated results from the KRYSTAL-7 Phase 2 study evaluating adagrasib combined with pembrolizumab in patients with first-line NSCLC with a KRASG12C mutation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO) (Free ESMO Whitepaper) 2023.
•In September, the Company shared 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 at 2023 World Conference on Lung Cancer (WCLC).
•In September, the Company shared that adagrasib has been included in the National Comprehensive Cancer Network (NCCN) Guidelines for Colon and Rectal Cancer 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.
•The Company continues to enroll 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 ongoing.
MRTX1719 (MTA cooperative PRMT5 inhibitor)
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•In August, the Company shared initial clinical data in patients with MTAP-deleted cancers. The Company continues to enroll patients in the Phase 1/2 clinical study.
MRTX1133 (Potent and selective KRASG12D inhibitor)
•The Company continues to enroll patients in the Phase 1/2 clinical study.
MRTX0902 (Potent SOS1 inhibitor)
•The Company continues to advance the Phase 1/2 clinical study evaluating the combination of MRTX0902 plus adagrasib.
Recent Corporate Updates
•In October, the Company and Bristol Myers Squibb announced their entry into a merger agreement under which Bristol Myers Squibb has agreed to 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 anticipated 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, the Company executed an underwritten public offering.
Third Quarter Financial Results
•Cash, cash equivalents and short-term investments of approximately $976.4 million as of September 30, 2023, including proceeds from an August 2023 public offering of our common stock that generated net proceeds of $332.5 million. Excluding the August 2023 financing, 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. Net product revenue during the three and nine months ended September 30, 2023 is comprised of $15.1 million and $33.1 million, respectively, of commercial sales and $1.3 million and $3.0 million, respectively, of 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, of which $1.4 million and $3.0 million, respectively, related to 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 primarily driven by a reduction in clinical development costs for sitravatinib as the Company is no longer pursuing further clinical development, 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 an increase in 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.