BCG Tokyo-172 Strain Vaccine / Japan BCG Laboratory, ImmunityBio - LARVOL DELTA

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 Press Release) - "At a median follow-up of 4.6 years, results presented at the February 2026 ASCO Genitourinary Cancers Symposium (Svatek RS, et al. J Clin Oncol. 2026;44[7 suppl]:LBA629) demonstrated non-inferiority of intravesical Tokyo strain of BCG versus intravesical TICE BCG on the primary endpoint of HGRFS (HR 0.82; 95.8% CI 0.63–1.08), with the upper confidence bound well below the pre-specified non-inferiority margin of HR 1.34. Complete response (CR) in carcinoma in situ (CIS) at 6 months was 66.4% (Tokyo) versus 70.2% (TICE). Progression-free survival was similar across arms. The estimated 5-year HGRFS was 64% in the Tokyo arm, 58% in the TICE arm....ImmunityBio is in discussions with the SWOG Cancer Research Network, the NCI, and Fred Hutchinson Cancer Research Center to establish a Data Use Agreement that would allow incorporation of the S1602 data into the company’s planned BLA submission."

P3 data • Bladder Cancer

ImmunityBio Signs Exclusive U.S. Agreement with Japan BCG Laboratory for the Tokyo Strain of BCG to Enhance BCG Supply in the United States (ImmunityBio Press Release) - "The agreement provides ImmunityBio exclusive U.S. rights to develop, import, and commercialize intravesical Tokyo-172 BCG....ImmunityBio plans to engage with the FDA to pursue U.S. approval of the Tokyo strain of BCG and will lead all regulatory submissions, clinical development, and commercialization in the United States as the sole BLA applicant. Upon any approval, ImmunityBio will be the sole Marketing Authorization Holder....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) in Washington, DC, on May 16, 2026 at 1:30 p.m. EDT."

FDA event • Licensing / partnership • Bladder Cancer

S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=1000 | Active, not recruiting | Sponsor: SWOG Cancer Research Network | Trial completion date: Sep 2025 ➔ Jun 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=1000 | Active, not recruiting | Sponsor: SWOG Cancer Research Network | Trial completion date: Feb 2025 ➔ Sep 2025 | Trial primary completion date: Dec 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer