CULVER CITY, Calif. - ImmunityBio, Inc. (NASDAQ:IBRX), a biotechnology firm, has announced the assignment of a unique permanent J-code for ANKTIVA (nogapendekin alfa inbakicept-pmln) by the Centers for Medicare & Medicaid Services (CMS), effective January 1, 2025. The U.S. Food and Drug Administration (FDA) has approved ANKTIVA, combined with Bacillus Calmette-Guérin (BCG), for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
Healthcare providers can now use the J-code, J9028, to facilitate the billing process for ANKTIVA, which is administered intravesically. J-codes are part of a standardized coding system in the United States used by government and commercial payers to streamline the reimbursement process for medications and treatments. While the company maintains strong liquidity with a current ratio of 2.68, InvestingPro data reveals the company is rapidly burning through cash, a common characteristic among developing biotech firms. Subscribers can access 8 additional ProTips about ImmunityBio’s financial position.
Dr. Patrick Soon-Shiong, Founder and Chief Officer of ImmunityBio, stated that the J-code for ANKTIVA marks a significant step in their mission to advance immunotherapy by harnessing the power of natural killer (NK) cells to aid patients with bladder cancer.
Richard Adcock (JO:AIPJ), President and CEO of ImmunityBio, highlighted the drug’s impact, noting that approximately 30-40% of NMIBC patients do not respond to standard BCG therapy, and for half of those who do, the cancer recurs. He mentioned the QUILT 3.032 study, which showed a 71% complete response rate in patients with BCG-unresponsive NMIBC CIS as of November 2024, with responses lasting up to 54 months.
Since its launch in May 2024, ANKTIVA has become available to patients through commercial and government insurance programs, with ImmunityBio securing coverage for over 200 million individuals.
ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex that stimulates immune cells, including NK and CD8+ killer T cells, which are crucial for eliminating cancer cells. It has been designed to mimic the biological properties of the membrane-bound IL-15 receptor alpha and has shown improved pharmacokinetics and anti-tumor activity in vivo compared to non-complexed IL-15.
ImmunityBio is focused on developing therapies and vaccines to empower the natural immune system to combat cancers and infectious diseases. ANKTIVA has been designated a Breakthrough Therapy by the FDA for NMIBC CIS, activating various immune cells for a sustained response. Financial metrics from InvestingPro indicate analysts expect 25% revenue growth in FY2024, though the company is not anticipated to achieve profitability this year. With the next earnings report due on March 4, 2025, investors seeking detailed analysis can access comprehensive financial health scores and valuation metrics through InvestingPro’s advanced analytics platform.
This article is based on a press release statement, and the information it contains reflects the views of ImmunityBio at the time of the press release. The company’s forward-looking statements involve risks and uncertainties, and actual results may differ.
In other recent news, ImmunityBio, Inc. announced plans for a public stock offering and a partnership with software company nCartes, Inc. to streamline data processes in clinical trials. The public offering aims to fund the commercialization of ANKTIVA®, a treatment for bladder cancer, and other corporate purposes. The offering’s completion, timing, and size depend on market conditions and will be managed by Jefferies, Piper Sandler, BTIG, and H.C. Wainwright & Co.
The partnership with nCartes is expected to expedite data collection and potentially speed up the introduction of new therapies. The collaboration will also reduce costs associated with data verification. In the financial sector, EF Hutton issued a Buy rating for ImmunityBio with a stock target of $30.00, recognizing the potential of the company’s cancer therapy, Anktiva. Meanwhile, Piper Sandler maintained a Neutral rating on the company’s stock.
ImmunityBio also reported positive results from its QUILT 3.055 trial, which demonstrated prolonged survival in patients with advanced non-small cell lung cancer (NSCLC). The trial used ANKTIVA in combination with checkpoint inhibitors KEYTRUDA or OPDIVO, prompting the initiation of Phase 3 trials for 1st and 2nd line NSCLC treatment. Lastly, ImmunityBio re-elected nine directors at its Annual Meeting of Stockholders and approved an increase in the number of shares authorized for issuance under its 2015 Equity Incentive Plan.
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