After FDA rejection, ImmunityBio lays off staff in California and Florida

After an FDA rejection earlier this year, ImmunityBio has laid off around 50 employees across California and Florida—its second layoff wave in less than a year.

Forty-eight job cuts were reported in a Sept. 19 California Worker Adjustment and Retraining Notification (WARN) report. The permanent layoffs impacted employees located in El Segundo, California, one of the immunotherapy biotech’s seven locations, according to the company’s website.

The layoffs also impacted remote workers who report to the El Segundo office, according to an ImmunityBio letter (PDF) filed in Florida.

“We have provided WARN ACT notices to California state and local officials, but are also providing this notice to you out of an abundance of caution because one or more of the affected employees in the layoff works remotely and resides in your jurisdiction,” the letter reads.

The Florida letter breaks down each job eliminated for a total of 50 layoffs, with one of those layoffs occurring in Florida. It’s unclear if 48 or 50 employees total were laid off. The reductions were across 16 departments and multiple offices and impacted less than 10% of the company's total staff, an ImmunityBio spokesperson told Fierce Biotech over email.

The clinical-stage company expects the Florida layoff to be complete by Oct. 17. All of the cuts are occurring so ImmunityBio can “streamline operations” and reduce costs, according to the letter.

The job terminations are the company’s second wave of layoffs to occur in less than a year. Last October, the company backtracked on hiring for its New York facility. Initially, ImmunityBio had pledged to hire 300 employees at the site, but later said it planned to let go of 38 workers by the end of the year.

The most recent cuts follow an FDA rejection this spring. In May, the company was hit with a complete response letter from the agency for its bladder cancer prospect—a combination of its drug Anktiva with Bacillus Calmette-Guérin (BCG), a vaccine mainly used against tuberculosis. The treatment is designed for patients with BCG-unresponsive, non-muscle invasive bladder cancer.

“The deficiencies relate to the FDA’s pre-license inspection of the company’s third-party contract manufacturing organizations,” ImmunityBio said in a May 9 filing. “Satisfactory resolution of the observations noted at the pre-license inspection is required before the [application] may be approved.”

ImmunityBio said it will “diligently address and resolve the issues identified and seek approval as expeditiously as possible.”  

Earlier this month, the biotech announced a $200 million convertible debt note from Nant Capital, an entity affiliated with Patrick Soon-Shiong, ImmunityBio’s billionaire founder, executive chair and global chief scientific and medical officer.

The financing transactions also include a one-year extension of the nearest-term debt payments for existing obligations with Nant, pushing payments back to December 2024.

The changes make ImmunityBio “well-positioned” to fund business operations and pre-commercialization efforts for the potential regulatory approval of its bladder cancer prospect, according to a Sept. 11 release.