ImmunityBio’s Anktiva Approved for Treating Non-Muscle Invasive Bladder Cancer (NMIBC)
ImmunityBio, Inc. has announced the FDA approval of Anktiva, its IL-15 immunotherapy, for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This is a major milestone for ImmunityBio, marking the first commercial product for the company founded a decade ago.
The approval is based on a trial involving 77 patients, in which Anktiva demonstrated a complete response rate (CR rate) of 62% and a duration of response (DOR) of 58% at 12 months. Anktiva is administered intravesically, directly into the bladder through a catheter, with an induction dosing schedule of once weekly for six weeks, followed by less frequent maintenance dosing.
Market Landscape for NMIBC Treatment
Anktiva enters a growing market for NMIBC treatment. Merck & Co.’s Keytruda, an immunotherapy, was approved for BCG-unresponsive NMIBC in 2020, while Adstiladrin, a gene therapy, received approval in 2022. Emerging therapies, such as TAR-200 (sustained local release of gemcitabine) and CG0070 (an oncolytic virus), are also showing promising results in clinical trials.
The US market for NMIBC was estimated at $1.7 billion in 2023 and is projected to continue growing. Analysts estimate that Anktiva could generate up to $1 billion in annual revenue within a few years. However, fierce competition is expected in the near future, which may limit Anktiva’s growth potential.
ImmunityBio’s Financial Standing
As of December 31, ImmunityBio had $265.4 million in cash and cash equivalents, which is expected to increase by $100 million following the FDA approval of Anktiva. The company has a strong current ratio, indicating its ability to meet short-term obligations. However, ImmunityBio also has a high debt burden, with a debt-to-asset ratio of 2.16.
In 2023, ImmunityBio reported a net loss of $583.8 million, primarily due to high operating expenses (R&D and SG&A) totaling $362.8 million. The company’s financial outlook beyond the next year is uncertain due to multiple obligations maturing over a longer period.
Analyst’s Recommendation
Despite the approval of Anktiva, analysts remain cautious about ImmunityBio’s long-term prospects. The competitive landscape and financial challenges facing the company raise concerns about Anktiva’s potential to sustain its growth. While Anktiva is a significant asset for ImmunityBio, its outlook in the second half of this decade is less optimistic than it appears now.
Given these factors, analysts recommend a “Sell” rating for ImmunityBio. However, it’s important to note that Anktiva’s success could alleviate some of the company’s financial challenges. Additionally, investigational therapies like TAR-200 may fail in later-stage trials, and Anktiva’s potential could be boosted if it proves effective in indications beyond NMIBC.
