Mirati CEO Takes Battleground Stance Against Amgen, Bows Out From KRAS Race

Mirati Therapeutics set a course for a new leadership chapter on Tuesday, with founder and president Charles Baum taking the reins of the company while it searches for a permanent replacement after the surprise resignation of CEO David Meek.

After a “mutually agreed” decision, Mark Meek is stepping down from his role at Mirati. Despite his departure from the company, Meek will still lend his expertise to the biotech until Oct. 15 in an advisory capacity. He will also be vacating his position on the Mirati Board of Directors.

Under the exemplary leadership of David, Mirati has seen tremendous success. From the launch of Krazati to the rapid advancement of Mirati’s innovative pipeline and the expansion of its team, David has been pivotal in driving Mirati forward. Chairman of the Board Faheem Hasnain praised David as having “made a significant impact during his tenure.”

In December 2022, the FDA made a groundbreaking decision, awarding accelerated approval to Mirati’s small molecule KRAS inhibitor Krazati (adagrasib). This authorization is for use in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the G12C KRAS mutation, making it the second such therapeutic to receive the go-ahead from the agency. With Amgen’s KRAS therapeutic Lumakras (sotorasib) greenlit in May 2021 for the same indication, the field is now open to competitive market forces.

On Tuesday, Mirati happily announced a $13.4 million net revenue in the second quarter of 2023 for its drug, Krazati. Despite the good news, Amgen’s Lumakras sales were well ahead with a total of $77 million. Unfortunately, the European Medicine Agency’s Committee for Medicinal Products for Human Use issued a negative opinion for Krazati’s conditional marketing authorization, which may hinder its growth in the near future.

Mirati is making strides in its development of Krazati, including a Phase II study that could soon bring Krazati into the frontline setting in NSCL C and a Phase III trial testing its combination with Lilly’s EGFR blocker Erbitux (cetuximab) as a potential second-line treatment in colorectal cancer. With these efforts, Mirati is working hard to bring relief to those suffering from cancer.

Mirati announced in its second-quarter update that by the end of the year, a Phase III study will be launched in the first-line NSCLC to evaluate the combination regimen of Krazati and Merck’s revolutionary Keytruda (pembrolizumab). This high-stakes trial has the potential to redefine the treatment landscape for NSCLC and beyond.

After a major misstep in May 2023, when its investigational kinase inhibitor, sitravatinib, failed to hit the primary efficacy mark in the Phase III SAPPHIRE study, Mirati chose to discontinue all development of sitravatinib in combination with Bristol Myers Squibb’s Opdivo (nivolumab) for non-squamous NSCLC. This blunder ultimately led to Alan P. Meek’s resignation as president and CEO of Mirati Therapeutics.

Mirati rocked the market Wednesday with their announcement of a $300 million public offering of common stock. Although the company previously announced $250 million worth of sale, it increased the aggregate to a whopping $300 million just hours later. Investors reacted to this news with a 6% drop in after-hours trading.

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