Saudi Approval for ANKTIVA Expands Market but Fails to Mitigate ImmunityBio's Deep Financial and Regulatory Risks

What happened

The Saudi Food and Drug Authority granted accelerated approval to ImmunityBio's ANKTIVA plus BCG for bladder cancer, adding to existing regulatory clearances and potentially opening a new geographic market. This news follows the company's early commercial traction with ANKTIVA, which drove $75 million in revenue over nine months in 2025, up from $7.2 million in the prior year period. However, ImmunityBio remains structurally loss-making, reporting a $289.5 million net loss in the same nine months, with persistent cash burn of around $70-$100 million per quarter and negative equity. The approval does not address key overhangs such as pending EMA decisions, intense competition from Keytruda and Adstiladrin, or a complex capital structure including a $505 million related-party convertible note. Investors should see this as a minor positive that reinforces ANKTIVA's viability but does not materially de-risk the binary investment thesis centered on execution and financing.

Implication

Saudi approval expands ANKTIVA's addressable market, potentially contributing to future sales growth in a region with unmet medical needs. However, this incremental gain is overshadowed by the company's $257.8 million cash balance against ongoing quarterly cash burn, requiring further dilutive capital raises. Regulatory risks persist with pending EMA reviews and FDA demands for randomized trials in papillary NMIBC, which could delay label expansions. Competition remains intense from established therapies like Keytruda, limiting ANKTIVA's market share potential despite the new approval. Consequently, investors should maintain a cautious stance, as the news does not alter the high-risk profile tied to single-asset dependence and financial instability.

Thesis delta

The Saudi approval represents a positive regulatory milestone that extends ANKTIVA's global footprint, slightly enhancing revenue prospects. However, it does not meaningfully shift the investment thesis, as core risks—including persistent cash burn, regulatory setbacks in key markets, and reliance on dilutive financing—remain unaddressed. The overall 'WAIT' stance from the DeepValue report is unchanged, with continued monitoring needed for commercial execution and funding developments.