ImmunityBio, Inc. filed a Form 8-K on November 9, 2026, disclosing that ANKTIVA plus Bacillus Calmette-Guérin met the primary endpoint in Cohort A of its BCG-naive non-muscle invasive bladder cancer randomized QUILT-2.005 trial.

Key Highlights

  • Primary endpoint met: ANKTIVA plus BCG met the primary endpoint in Cohort A of the QUILT-2.005 trial, according to the filing.
  • Trial population: The QUILT-2.005 trial targets BCG-naive non-muscle invasive bladder cancer patients, as described in the disclosure.
  • Trial design: The company disclosed the QUILT-2.005 study is a randomized trial.
  • Announcement date: ImmunityBio issued a press release announcing the result on November 9, 2026.
  • Disclosure channel: The press release was furnished as Exhibit 99.1 and reported under Regulation FD (Item 7.01) of the current report.
  • Signatory: The filing was signed by David C. Sachs, Chief Financial Officer of ImmunityBio, Inc.

ImmunityBio Reports QUILT-2.005 Cohort A Primary Endpoint Result

ImmunityBio, Inc. (NASDAQ:IBRX) disclosed on November 9, 2026, through a Regulation FD current report, that its combination therapy of ANKTIVA and Bacillus Calmette-Guérin met the primary endpoint in Cohort A of the QUILT-2.005 trial. According to the filing, QUILT-2.005 is a randomized study evaluating BCG-naive patients with non-muscle invasive bladder cancer.

The company disclosed that a press release, dated November 9, 2026, containing the full details of the announcement was furnished as Exhibit 99.1 to the current report. The filing noted that the information reported under Item 7.01, including the attached press release, "shall not be deemed 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934" and is not subject to the liabilities of that section, nor is it deemed incorporated by reference into other company filings unless specifically stated.

The 8-K was signed by David C. Sachs, Chief Financial Officer of ImmunityBio, Inc., on November 9, 2026. ImmunityBio is a Delaware-incorporated company headquartered at 3530 John Hopkins Court, San Diego, California 92121, and its common stock, par value $0.0001 per share, trades on The Nasdaq Global Select Market under the ticker symbol IBRX.

What Was Disclosed

ImmunityBio filed an 8-K on November 9, 2026, reporting under Regulation FD that ANKTIVA plus BCG met the primary endpoint in Cohort A of the randomized QUILT-2.005 trial in BCG-naive non-muscle invasive bladder cancer. Full details were furnished via a press release as Exhibit 99.1.