ImmunityBio, Inc. - IBRX STOCK NEWS

ImmunityBio (NASDAQ: IBRX) announces plans for three FDA submissions in 2025: a supplemental BLA for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) in papillary indication, a regulatory submission for an alternative BCG source in partnership with Serum Institute of India, and a BLA for second- and third-line non-small cell lung cancer (NSCLC) treatment.

For NMIBC, clinical data showed a 55% disease-free rate at 12 months and 93% cystectomy avoidance. The QUILT-3.055 Phase 2b study for NSCLC (N=86) demonstrated 14.1 months median overall survival for all patients, extending to 15.8 months in PD-L1 negative subjects, comparing favorably to standard docetaxel treatment's 7-10 months survival rate.

ImmunityBio (NASDAQ: IBRX) announced that its FDA-approved bladder cancer treatment ANKTIVA® has received a permanent J-code (J9028), effective January 1, 2025. The code will streamline billing and reimbursement processes for the drug, which is approved for adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.

The company highlighted that ANKTIVA, launched in May 2024, has demonstrated a 71% complete response rate in ongoing QUILT 3.032 study as of November 2024, with response duration up to 54 months. The treatment has secured coverage for over 200 million medical lives through various insurance programs, including VA, DoD, and Medicare.

ImmunityBio (NASDAQ: IBRX) has announced the pricing of its public offering of 33,333,334 shares of common stock at $3.00 per share, expecting to raise approximately $100.0 million in gross proceeds. The company has granted underwriters a 30-day option to purchase up to an additional 5,000,000 shares.

The offering is expected to close around December 12, 2024. The proceeds will be used to advance the commercialization of ANKTIVA® for BCG-unresponsive NMIBC treatment, fund trials in BCG-naïve NMIBC and NSCLC, support research and development, working capital needs, and general corporate purposes. Jefferies and Piper Sandler are serving as joint book-running managers.

ImmunityBio (NASDAQ: IBRX) has announced plans for an underwritten public offering of its common stock. The company will grant underwriters a 30-day option to purchase up to an additional 15% of offered shares. Proceeds will fund ANKTIVA® commercialization for BCG-unresponsive non-muscle invasive bladder cancer treatment, trials in BCG-naïve NMIBC and non-small cell lung cancer, R&D activities, working capital needs, and general corporate purposes. Jefferies and Piper Sandler are acting as joint book-running managers, while BTIG and H.C. Wainwright & Co. serve as co-lead managers.

ImmunityBio (NASDAQ: IBRX) and nCartes have entered a collaboration agreement to automate and streamline clinical trial data fulfillment processes. The partnership aims to replace manual data entry into Electronic Data Capture (EDC) systems with direct digital information transfer from electronic medical record (EMR) systems. This automation initiative is designed to make the process faster, more cost-effective, and reduce potential errors in data entry. The collaboration seeks to improve data quality and reduce the time required for source data verification, potentially accelerating the timeline for bringing therapies to market.

ImmunityBio (NASDAQ: IBRX) has announced new data from its QUILT 3.032 study, where 100 patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC CIS) were treated with ANKTIVA in combination with BCG. The treatment achieved a 71% complete response rate, with durable responses extending up to 54 months. The company plans to submit this updated data to the European Medicines Agency (EMA) in Q4 2024 as part of a Marketing Authorization Application. The results align with previous findings published in the New England Journal of Medicine and demonstrate ANKTIVA's potential in treating patients with treatment options.

ImmunityBio (NASDAQ: IBRX) reported Q3 2024 financial results, highlighting $6.0 million in net product revenue from ANKTIVA®, significantly up from $1.0 million in the previous quarter. The company secured coverage for over 200 million medical lives and received a J-code effective January 2025. ANKTIVA's shelf life was extended to three years with 125,000 doses available. The company submitted MAA applications in the UK and plans EU submission in Q4 2024. Financial results showed cash position of $130.4 million, with a net loss of $85.7 million compared to $95.6 million in Q3 2023. R&D expenses increased to $50.4 million, while SG&A expenses rose to $35.9 million.

ImmunityBio (NASDAQ: IBRX) has initiated dosing in its Phase 1 clinical trial of CAR-NK cell therapy for treating relapsed B-cell Non-Hodgkin Lymphoma. The QUILT 106 trial, testing CD19-targeted high-affinity natural killer cells, represents the first NK cell-based therapy study in Africa. The trial will enroll up to 10 participants across three South African cities. Initially testing the therapy as a single agent, the study will later combine it with rituximab after safety confirmation. Full enrollment is expected in Q1 2025, with topline data anticipated in H2 2025. This trial mirrors the company's U.S.-based QUILT 3.092 study.

ImmunityBio (NASDAQ: IBRX), an immunotherapy innovator, has announced its participation in the Jefferies London Healthcare Conference. The event is scheduled for November 19-21, 2024 at the Waldorf Hilton London. Company executives will engage in a fireside chat on Tuesday, November 19, 2024, at 2:30 PM GT.

Investors and interested parties can access a replay of the recorded presentation through the Events and Presentations section of ImmunityBio's website at https://ir.immunitybio.com/. The replay will be available for 90 days following the conference.