Entry into a Material Definitive Agreement · Regulation FD Disclosure
Item 1.01. Entry into a Material Definitive Agreement. On May 14, 2026, ImmunityBio, Inc., a Delaware corporation (“ImmunityBio” or the “Company”), entered into an exclusive development and supply agreement (the “Agreement”) with Japan BCG Laboratory, a Japanese corporation (“JBL”).…
Filed May 18, 2026Accepted May 18, 2026, 5:20 PM EDTCIK 1326110Accession 0001193125-26-229153
ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by an investigational portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.
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Item 1.01Item 1.01 - Entry into Material Agreement
Item 1.01. Entry into a Material Definitive Agreement.
On May 14, 2026, ImmunityBio, Inc., a Delaware corporation (“ImmunityBio” or the “Company”), entered into an exclusive development and supply agreement (the “Agreement”) with Japan BCG Laboratory, a Japanese corporation (“JBL”). Pursuant to the Agreement, JBL will manufacture and exclusively supply Tokyo-172 strain of Bacillus Calmette-Guerin (“BCG”) (the “Product”) to ImmunityBio for use in the United States and its territories (the “Territory”), pursuant to the terms and subject to the limitations set forth in the Agreement.
JBL will manufacture and supply the Product to ImmunityBio, and ImmunityBio will be solely responsible for all development activities, including preclinical studies and clinical trials, as well as obtaining and maintaining all regulatory approvals required to market and sell the Product in the Territory.
The Agreement grants ImmunityBio exclusive rights to purchase, import, sell and distribute Product in the Territory for an initial term of ten (10) years from the date of FDA approval of the Product. The Agreement also provides ImmunityBio with a right of first negotiation to obtain rights to develop and commercialize the Product in jurisdictions outside the Territory (excluding certain Asian regions including Japan) following the commencement of commercial production.
No payment is due from ImmunityBio to JBL prior to FDA approval of the Product. All vials supplied for regulatory submission shall be provided at no cost to ImmunityBio. Following FDA approval, ImmunityBio has committed to purchase at least 2 batches of Product per year. ImmunityBio shall use commercially reasonable efforts to launch and commercialize the Product in the Territory upon obtaining FDA approval.
The Agreement contains customary representations, warranties, indemnification, and confidentiality provisions. Either party may terminate the Agreement upon written notice in the event of an uncured material breach by the other party or upon the other party’s insolvency. ImmunityBio may also terminate the Agreement for convenience upon prior written notice.
The foregoing is only a brief description of the material terms of the Agreement, does not purport to be a complete description of the rights and obligations of the parties thereunder, and is qualified in its entirety by reference to the full text of the Agreement, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2026.
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01. Regulation FD Disclosure.
On May 16, 2026, the Company issued a press release announcing the Agreement described in Item 1.01 above (the “Agreement Press Release”). The Agreement Press Release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated into this Item 7.01 by reference.
The information in this Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
Filed exhibits (1)
EX-99.1 (by filename) d75270dex991.htm
EX-99.1
2
d75270dex991.htm
EX-99.1
EX-99.1
Exhibit 99.1
ImmunityBio Signs Exclusive U.S. Agreement with Japan BCG Laboratory for the Tokyo Strain of BCG to
Enhance BCG Supply in the United States
Positive Phase III readout of National Cancer Institute sponsored SWOG S1602 randomized clinical trial
demonstrating non-inferior efficacy of the Tokyo strain of BCG (Tokyo-172 BCG) versus TICE BCG in BCG-naïve high-grade non-muscle invasive bladder cancer
ImmunityBio to serve as sole U.S. Biologics License Application applicant for the Tokyo strain of BCG and plans
to engage with U.S. Food and Drug Administration (FDA) on regulatory pathway to address the over decade long unresolved BCG shortage in the United States
Agreement positions ImmunityBio with second potential BCG source to help address U.S. supply needs
Through ImmunityBio’s ongoing partnership with Serum Institute of India, recombinant BCG (rBCG) remains
available to eligible patients under ImmunityBio’s FDA Expanded Access Program
Details of the Japan BCG Laboratory agreement will be shared during Dr. Patrick Soon-Shiong’s
presentation at the American Urological Association Annual Meeting (AUA 2026…