Immunitybio Inc Stock Price, News & Analysis

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.

ImmunityBio (NASDAQ: IBRX) received a Refusal to File (RTF) letter from the FDA regarding their supplemental biologics license application (sBLA) for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) for papillary disease. This decision contradicts the unanimous guidance received during a January 2025 meeting where FDA leadership encouraged the company to submit the sBLA. The treatment showed promising results with a 99% disease-specific survival rate at 12 months and 96% at 36 months, with over 82% of patients avoiding bladder removal. ANKTIVA was previously approved in 2024 for NMIBC with Papillary tumors with CIS. The company has requested an urgent meeting with the FDA to address these inconsistencies and explore the path forward.

ImmunityBio (NASDAQ: IBRX) announced positive long-term results from its QUILT-3.032 study of ANKTIVA® plus BCG for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The study showed:

For CIS with/without papillary disease (N=100):

• 71% complete response rate with responses up to 53+ months
• 84.2% cystectomy avoidance rate at 36 months
• 99% disease-specific survival rate at 36 months

For papillary disease without CIS (N=80):

• 58.2% disease-free survival rate at 12 months
• 82% cystectomy avoidance rate at 36 months
• 96% disease-specific survival rate at 36 months

The treatment was well-tolerated with mostly grade 1-2 adverse events. ImmunityBio has submitted a supplemental BLA to FDA for ANKTIVA plus BCG in BCG-unresponsive NMIBC papillary disease indication.

ImmunityBio (NASDAQ: IBRX) will present new clinical findings for ANKTIVA® in non-muscle invasive bladder cancer at the American Urological Association Annual Meeting (AUA 2025) in Las Vegas, April 26-29. The company will showcase updates from the QUILT-3.032 trial, demonstrating long-term efficacy data for ANKTIVA plus BCG in BCG-unresponsive NMIBC CIS.

Key presentations include an oral session on complete responses to ANKTIVA plus BCG therapy, and keynote events by Dr. Patrick Soon-Shiong discussing innovation in urological cancers. The company has submitted a Supplemental Biologics License Application for BCG unresponsive NMIBC and applied for Expanded Access Authorization of ANKTIVA as a BioShield for patients receiving chemotherapy, radiation, and immunotherapy.

ImmunityBio (NASDAQ: IBRX) has made significant regulatory and commercial progress in Q1 2025. The company submitted a supplemental Biologics License Application (sBLA) for ANKTIVA® plus BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) for papillary disease indication. Clinical data showed 88% and 82% probability of avoiding bladder removal at 2 and 3 years respectively.

The company also submitted an Expanded Access Protocol (EAP) for ANKTIVA to treat lymphopenia, following a Regenerative Medicine Advanced Therapy (RMAT) designation. Commercially, with a permanent J-code (J9028) awarded in January 2025, Q1 2025 saw strong growth with:

• Net product revenue of $16.5M, up 129% from Q4 2024's $7.2M
• ANKTIVA unit sales volume increased 150% over Q4 2024
• March sales volume grew 69% compared to February 2025

ImmunityBio (NASDAQ: IBRX) has secured a $75 million equity financing through a registered direct offering with a single institutional investor. The agreement includes the issuance of common stock and warrants for additional share purchases. If the warrants are fully exercised, they could generate up to approximately $90 million in additional gross proceeds.

The securities will be offered under the company's automatic shelf registration statement on Form S-3, with a final prospectus supplement to be filed with the SEC. The financing aims to provide working capital and support ongoing business operations.

ImmunityBio (NASDAQ: IBRX) has announced an Investor Day program scheduled for Tuesday, April 15, 2025, at 10:00 am PDT. The event will feature comprehensive updates on:

• Business operations and regulatory advances
• Clinical programs including bladder cancer, non-small cell lung cancer, and metastatic pancreatic cancer trials
• Natural killer (NK) cell therapy program and Lynch syndrome accrual
• Discussions on virally induced cancers and Long-COVID

The event will include fireside chats with distinguished key opinion leaders and a presentation by Dr. Patrick Soon-Shiong on the company's technology platforms. The in-person event will be held in El Segundo, California, with space availability, requiring advance RSVP. A live stream option will be available for remote attendance.