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Mirati (MRTX) Beats on Q3 Earnings, Begins NDA Adagrasib Filing
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Mirati Therapeutics reported third-quarter loss of $1.55 per share, which was narrower than the Zacks Consensus Estimate of a loss of $2.87 and the year-ago loss of $1.96.
While the company lacks marketed products in its pipeline, it reported $71.8 million as collaboration revenues for the third quarter as compared to $11.4 million in the year-ago quarter. The Zacks Consensus Estimate was $37.5 million.
Quarter in Detail
Research and development expenses rose 45.4% from the prior-year quarter to $116.1 million due to an increase in development expenses of adagrasib and preclinical as well as early discovery activities, and other employee-related expenses.
General and administrative expenses rose 73.8% from the year-ago quarter to $35.2 million due to an increase in professional services costs related to commercial scale-up, increased sponsorship agreement expenses and higher employee-related costs in the quarter.
Cash, cash equivalents and short-term investments as of Sep 30, 2021, were $1.2 billion, same as the last quarter.
Pipeline Update
The company’s clinical pipeline consists of two key candidates: adagrasib (MRTX849), a KRASG12C inhibitor, and sitravatinib, a multi-kinase inhibitor.
Adagrasib
Along with its earnings results, Mirati announced that it has initiated the submission of the new drug application (NDA) for adagrasib to treat patients with at least second-line non-small cell lung cancer (NSCLC) with KRAS G12C mutation, following prior systemic therapy under the Real-Time Oncology Review (RTOR) pilot program. The RTOR program aims to ensure that safe and effective treatments are available to patients as early as possible.
Shares of Mirati rose almost 9% in the after-hours trading on Monday, probably on the NDA-filing initiation news. Shares of the company have declined 27.2% in the year so far as compared to the industry’s 12.4% decline.
Image Source: Zacks Investment Research
The NDA was based on positive top-line data from the phase II potentially registration-enabling monotherapy-cohort evaluating adagrasib in the above-mentioned indication reported by the company in September. Data from the study demonstrated that treatment with adagrasib achieved an objective response rate of 43% and 80% disease control rate as of Jun 15, 2021. The NDA submission is expected to be completed by 2021-end.
The company also reported preliminary data from phase Ib cohort of the KRYSTAL-1 study, evaluating adagrasib plus Merck’s (MRK - Free Report) Keytruda for first-line NSCLC. Data from the study demonstrated that 400mg adagrasib administered twice daily in combination with a full dose of Keytruda achieved 100% disease control rate as of Oct 21, 2021. The preliminary data is also expected to support the ongoing phase II KRYSTAL-7 study, which will also evaluate 400mg adagrasib combined with Keytruda in NSCLC patients with KRAS G12C mutation.
Last month, Mirati entered into a non-exclusive clinical collaboration agreement with Sanofi (SNY - Free Report) to evaluate the combination of adagrasib with the latter's investigational SHP2 inhibitor SAR442720 (also known as RMC-4630) in a phase I/II dose escalation and expansion study in previously treated NSCLC patients with KRAS G12C mutations.
Apart from NSCLC, Mirati is evaluating adagrasib in other solid tumors as well. In September, the company reported positive data from a cohort of the phase I/II KRYSTAL–1 study, evaluating adagrasib in patients with heavily pre-treated colorectal cancer (CRC). This cohort evaluated adagrasib in two arms — as monotherapy and in combination with Eli Lilly’s (LLY) Erbitux. In both arms of the study, adagrasib achieved significant clinical activity and broad disease control in patients with KRAS G12C-Mutated CRC.
Sitravatinib
Sitravatinib has been designed to selectively target a spectrum of tyrosine kinases involved in both tumor growth and the suppression of immune responses to tumors. Mirati anticipates to provide updates based on an interim analysis of the overall survival from the currently enrolling phase III SAPPHIRE study in second-half 2022. The study is evaluating sitravatinib with Bristol Myers’ (BMY - Free Report) Opdivo in second or third-line non-squamous NSCLC.
Image: Bigstock
Mirati (MRTX) Beats on Q3 Earnings, Begins NDA Adagrasib Filing
Mirati Therapeutics reported third-quarter loss of $1.55 per share, which was narrower than the Zacks Consensus Estimate of a loss of $2.87 and the year-ago loss of $1.96.
While the company lacks marketed products in its pipeline, it reported $71.8 million as collaboration revenues for the third quarter as compared to $11.4 million in the year-ago quarter. The Zacks Consensus Estimate was $37.5 million.
Quarter in Detail
Research and development expenses rose 45.4% from the prior-year quarter to $116.1 million due to an increase in development expenses of adagrasib and preclinical as well as early discovery activities, and other employee-related expenses.
General and administrative expenses rose 73.8% from the year-ago quarter to $35.2 million due to an increase in professional services costs related to commercial scale-up, increased sponsorship agreement expenses and higher employee-related costs in the quarter.
Cash, cash equivalents and short-term investments as of Sep 30, 2021, were $1.2 billion, same as the last quarter.
Pipeline Update
The company’s clinical pipeline consists of two key candidates: adagrasib (MRTX849), a KRASG12C inhibitor, and sitravatinib, a multi-kinase inhibitor.
Adagrasib
Along with its earnings results, Mirati announced that it has initiated the submission of the new drug application (NDA) for adagrasib to treat patients with at least second-line non-small cell lung cancer (NSCLC) with KRAS G12C mutation, following prior systemic therapy under the Real-Time Oncology Review (RTOR) pilot program. The RTOR program aims to ensure that safe and effective treatments are available to patients as early as possible.
Shares of Mirati rose almost 9% in the after-hours trading on Monday, probably on the NDA-filing initiation news. Shares of the company have declined 27.2% in the year so far as compared to the industry’s 12.4% decline.
The NDA was based on positive top-line data from the phase II potentially registration-enabling monotherapy-cohort evaluating adagrasib in the above-mentioned indication reported by the company in September. Data from the study demonstrated that treatment with adagrasib achieved an objective response rate of 43% and 80% disease control rate as of Jun 15, 2021. The NDA submission is expected to be completed by 2021-end.
The company also reported preliminary data from phase Ib cohort of the KRYSTAL-1 study, evaluating adagrasib plus Merck’s (MRK - Free Report) Keytruda for first-line NSCLC. Data from the study demonstrated that 400mg adagrasib administered twice daily in combination with a full dose of Keytruda achieved 100% disease control rate as of Oct 21, 2021. The preliminary data is also expected to support the ongoing phase II KRYSTAL-7 study, which will also evaluate 400mg adagrasib combined with Keytruda in NSCLC patients with KRAS G12C mutation.
Last month, Mirati entered into a non-exclusive clinical collaboration agreement with Sanofi (SNY - Free Report) to evaluate the combination of adagrasib with the latter's investigational SHP2 inhibitor SAR442720 (also known as RMC-4630) in a phase I/II dose escalation and expansion study in previously treated NSCLC patients with KRAS G12C mutations.
Apart from NSCLC, Mirati is evaluating adagrasib in other solid tumors as well. In September, the company reported positive data from a cohort of the phase I/II KRYSTAL–1 study, evaluating adagrasib in patients with heavily pre-treated colorectal cancer (CRC). This cohort evaluated adagrasib in two arms — as monotherapy and in combination with Eli Lilly’s (LLY) Erbitux. In both arms of the study, adagrasib achieved significant clinical activity and broad disease control in patients with KRAS G12C-Mutated CRC.
Sitravatinib
Sitravatinib has been designed to selectively target a spectrum of tyrosine kinases involved in both tumor growth and the suppression of immune responses to tumors. Mirati anticipates to provide updates based on an interim analysis of the overall survival from the currently enrolling phase III SAPPHIRE study in second-half 2022. The study is evaluating sitravatinib with Bristol Myers’ (BMY - Free Report) Opdivo in second or third-line non-squamous NSCLC.
Mirati Therapeutics, Inc. Price
Mirati Therapeutics, Inc. price | Mirati Therapeutics, Inc. Quote
Zacks Rank
Mirati currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.