Immunitybio Inc Stock Price, News & Analysis

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.

ImmunityBio (NASDAQ: IBRX) has announced an upcoming Investor Day scheduled for Tuesday, April 15, 2025, at 10:00 am PDT. The event will be hosted at their El Segundo, California facilities, offering both in-person attendance and live streaming options.

The program will feature comprehensive updates on business operations and R&D progress, including presentations from CEO Richard Adcock and Founder Dr. Patrick Soon-Shiong. Key highlights will include:

• Discussion of product candidate timelines and ongoing clinical trials
• Detailed overview of the company's technology platforms
• Presentation on ANKTIVA, their initial therapeutic
• Tour of manufacturing facilities demonstrating production capabilities

The company's focus remains on developing a Therapeutic BioShield across multiple tumor types, leveraging their innovative approach to immunology for long-term disease protection and prevention.

ImmunityBio (NASDAQ: IBRX) has initiated dosing of recombinant BCG (rBCG) in the U.S. through its FDA-authorized Expanded Access Program (EAP). U.S. Urology Partners is among the first providers to offer this alternative BCG treatment, with 60 sites preparing for launch.

The program addresses critical TICE® BCG shortages affecting bladder cancer treatment nationwide. A recent survey of 100 U.S. urologists revealed that 57% couldn't treat patients in the past year due to BCG access issues.

The rBCG, manufactured by the Serum Institute of India, has shown promising results in European clinical trials, demonstrating potent immunogenicity with CD8+ and CD4+ T cell stimulation and improved safety compared to earlier BCG formulations. The EAP is being managed by Anova Enterprises, Inc., providing an essential alternative source for this standard-of-care treatment in bladder cancer.

ImmunityBio (NASDAQ: IBRX) reported strong growth following its ANKTIVA product's permanent J-code issuance in January 2025. February 2025 unit sales volume increased 97% compared to December 2024, with a 67% month-over-month growth from January 2025.

Key financial highlights include Q4 2024 net product revenue of $7.2 million, a 21% increase from Q3's $6.0 million. The company's cash position stood at $149.8 million as of December 31, 2024. Annual net loss decreased to $413.6 million in 2024 from $583.2 million in 2023.

Notable developments include:

• FDA authorization for expanded access to alternative BCG source with 45,000 doses available
• MHRA and EMA acceptance of marketing authorization applications for ANKTIVA
• RMAT designation for ANKTIVA and CAR-NK combination therapy
• BeOne Medicines collaboration for Phase 3 NSCLC trial

ImmunityBio (NASDAQ: IBRX) has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for ANKTIVA® and CAR-NK therapy. This designation covers two key applications: reversing lymphopenia in patients receiving standard chemotherapy/radiotherapy, and treating multiply relapsed locally advanced or metastatic pancreatic cancer.

The designation follows clinical data from QUILT trials showing significant correlations between Absolute Lymphocyte Count (ALC) and Overall Survival (OS) across multiple tumor types. ANKTIVA has demonstrated ability to proliferate and activate NK cells, CD4+ T cells, CD8+ T cells, and memory T cells without increasing suppressive T regulatory cells.

The company plans to submit a Biologic License Application (BLA) for both indications and will provide data from fully enrolled clinical trials in metastatic pancreatic cancer (QUILT-88) and checkpoint relapsed NSCLC (QUILT-3.055). Additionally, ImmunityBio will file an Expanded Access Policy (EAP) for ANKTIVA and PD-L1 t-haNK in combination with standard care within 15 days.

ImmunityBio (NASDAQ: IBRX) has received FDA authorization for an expanded access program (EAP) to provide recombinant BCG (rBCG), addressing the critical shortage of TICE® BCG for bladder cancer treatment in the US. The alternative BCG source, developed by the Serum Institute of India, has shown promising results in European clinical trials, demonstrating potent immunogenicity and improved safety compared to earlier BCG strains.

A recent Sermo survey revealed that 57% of US urologists were unable to treat patients in the last 12 months due to TICE® BCG shortage. The company has thousands of vials ready for immediate shipment, potentially resolving this significant treatment impediment. The rBCG has completed Phase 2 clinical trials in Europe for non-muscle invasive bladder cancer (NMIBC).

ImmunityBio (NASDAQ: IBRX) announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has validated and accepted the marketing authorization application for ANKTIVA®. The application is for ANKTIVA® in combination with BCG for treating patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.

This acceptance follows the European Medicines Agency's recent review acceptance for 30 EU countries and comes 10 months after FDA approval in the United States. The MHRA will now begin assessing the marketing authorization application for potential approval in the UK market.