Immunitybio Inc Stock Price, News & Analysis

ImmunityBio (NASDAQ: IBRX) announced that Houston's Michael E. DeBakey VA Medical Center has become one of the first VA hospitals in the United States to administer ANKTIVA® to veterans with bladder cancer. The treatment, recently FDA-approved, combines ANKTIVA with BCG for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

This development is particularly significant as a 2024 study revealed veterans face higher bladder cancer risks due to military exposure to carcinogenic agents. The initiative was led by urologic oncologists Dr. Jeffrey Jones and Dr. Jennifer Taylor, who were instrumental in bringing this treatment to veterans and enrolling the facility in ImmunityBio's Expanded Access Program for rBCG.

ImmunityBio (NASDAQ: IBRX) reported strong Q2 2025 financial results, with revenue reaching $26.4 million, a 60% increase from Q1 2025. Year-to-date sales reached $43 million, with ANKTIVA unit sales volume growing 246% in 1H 2025 compared to 2H 2024.

The company's financial position shows $153.7 million in cash and equivalents as of June 30, 2025, bolstered by an additional $80 million equity financing in July 2025. Despite revenue growth, the company reported a net loss of $92.6 million in Q2 2025, an improvement from the $134.6 million loss in Q2 2024.

Key developments include the launch of ResQ201A trial for non-small cell lung cancer, progress in the lymphopenia program, and UK MHRA approval for ANKTIVA in bladder cancer treatment. The company is addressing FDA requirements regarding its papillary NMIBC program and evaluating regulatory strategy options.

ImmunityBio (NASDAQ: IBRX) has secured an $80 million registered direct offering through a securities purchase agreement with two institutional investors. The offering includes common stock and warrants for additional share purchases.

The warrants, if fully exercised, could generate up to $96 million in additional gross proceeds. Piper Sandler & Co. is serving as the exclusive placement agent for this offering, which is being conducted under ImmunityBio's automatic shelf registration statement on Form S-3.

ImmunityBio (NASDAQ: IBRX) reported strong Q2 2025 financial results and clinical progress. The company achieved revenue of $26.4 million, a 60% increase from Q1 2025, with year-to-date sales reaching $43 million. ANKTIVA® unit sales volume grew 246% in 1H 2025 compared to 2H 2024. The company maintained a solid cash position of $153.7 million.

Key developments include initiating the ResQ201A trial for lung cancer, receiving MHRA marketing authorization for ANKTIVA, and ongoing FDA discussions regarding papillary NMIBC following a Refuse-to-File decision. The company is evaluating regulatory strategies for papillary-only NMIBC and has applied to NCCN for guideline expansion. Additionally, the FDA showed support for the lymphopenia program with an active Expanded Access Program.

ImmunityBio (NASDAQ: IBRX) has received UK MHRA approval for ANKTIVA® in combination with BCG to treat BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ. This marks ANKTIVA's first marketing authorization outside the United States.

ANKTIVA, a first-in-class IL-15 agonist, works by activating and proliferating natural killer (NK) and T cells. The therapy demonstrated impressive clinical results, with some patients showing complete response duration exceeding 47 months in a trial of 77 evaluable patients. The treatment offers new hope for the 16,400 to 18,000 people diagnosed with NMIBC annually in the UK.

The company is also pursuing regulatory approval with the European Medicines Agency (EMA) to expand ANKTIVA's availability across the EU member states, Iceland, Norway, and Liechtenstein.

ImmunityBio (NASDAQ: IBRX) presented groundbreaking results at ASCO 2025 for ANKTIVA, the first-ever treatment for lymphopenia, showing significant survival benefits in advanced pancreatic cancer patients. The study of 86 patients with 3rd-6th line metastatic pancreatic cancer demonstrated that ANKTIVA, combined with CAR-NK therapy and low-dose chemotherapy, successfully reversed lymphopenia in 67 patients. Those achieving lymphopenia reversal (ALC ≥1,000) showed significantly improved survival (P=0.005, HR: 0.46). Notably, patients with lower tumor burden and improved lymphocyte counts achieved a median overall survival of 10.1 months. ANKTIVA, approved in April 2024 for bladder cancer, represents the first lymphocyte-stimulating agent (LSA), addressing a critical gap in cancer treatment where only anemia (Epogen) and neutropenia (Neupogen) had existing therapies.

ImmunityBio (NASDAQ: IBRX) has received FDA Expanded Access authorization for ANKTIVA to treat lymphopenia in solid tumor patients who failed first-line treatments. Lymphopenia, a severe depletion of NK cells and T cells caused by cancer treatments, currently has no approved therapies despite being a major predictor of poor cancer outcomes. ANKTIVA, an IL-15 superagonist, is the first approved therapy to restore lymphocyte levels without triggering immunosuppressive effects. The company presented significant results at ASCO 2025 showing improved survival in late-stage pancreatic cancer patients using ANKTIVA with CAR-NK therapy. A notable case study showed a patient with 2nd line metastatic pancreatic cancer achieving 6+ years of remission using the full Cancer BioShield platform. In February 2025, the company received RMAT designation for ANKTIVA and CAR-NK therapy, potentially expediting development for lymphopenia reversal in cancer patients.

ImmunityBio (NASDAQ: IBRX) has signed a strategic MOU with Saudi Arabia's Ministry of Investment, King Faisal Specialist Hospital & Research Centre, and King Abdullah International Medical Research Center to introduce its FDA-approved Cancer BioShield platform to the Middle East. The platform, powered by Anktiva®, is the first FDA-approved IL-15 superagonist that proliferates NK and T cells. Unlike traditional cancer treatments that suppress immune cells, BioShield protects and activates the immune system's natural killer cells and T cells. The collaboration includes plans to establish Middle East subsidiaries, conduct clinical trials, and transfer scientific expertise. The partnership aims to create a regional center of excellence for next-generation immunotherapies and supports Saudi Arabia's goals to become a global biotechnology hub.

ImmunityBio (NASDAQ: IBRX) reported strong Q1 2025 financial results, with net product revenue reaching $16.5 million, a 129% increase from Q4 2024's $7.2 million. The company's ANKTIVA® unit sales volume grew 150% in Q1 2025 compared to Q4 2024, with March volumes up 69% over February. Nearly 200 urology practices are registering for ImmunityBio's rBCG Expanded Access Program. The company completed a $75 million equity financing in April 2025. Financial highlights include decreased R&D expenses to $48.2 million (down $5.1M YoY) and reduced SG&A expenses to $32.7 million (down $9.2M YoY). Net loss improved to $129.6 million from $134.1 million in Q1 2024. The company's cash position stood at $136.4 million after the equity financing.