RE:total addressable market (“TAM”) = 500,000 patients TLT's treatment is not going the complicated route (BLA) that ImmunityBio is going. Much less risk for TLT.
A biotech with no products and no sources of income is always risky in a bear market. In a vacuum, ImmunityBio would be a buy on the strength of Antiva’s performance. But there are many moving parts, and not just with the company. ImmunityBio is unusual in that it doesn’t hold earnings calls; even a microcap like Galectin Therapeutics (GALT) with no catalysts on the horizon releases regular financial statements. More concerning is the lack of information on the FDA Type B Meeting scheduled for last month (Figure 4). The meeting would’ve concerned QUILT’s Cohort B (BCG-unresponsive high-grade Ta/T1 papillary NMIBC), which also recorded positive data.
There is a chance the BLA could get rejected for various reasons ranging from incompleteness, to concerns with adverse events, to deficiencies in areas other than clinical. Or it could be another Sesen situation. One of the company’s strengths is having its own GMP manufacturing facility, but inspectors might find problems with it. If there are delays in the BLA review, ImmunityBio will need to secure more financing, leading to more share dilution. But with its deep pipeline, the company should survive a rejection.
If Anktiva does earn an FDA nod, it could be priced competitively with Keytruda. At $200,000 per year, it would take 5,000 patients, a sizable fraction of NMIBC patients in the Tis stage, to be a blockbuster. However, another worsening of the global BCG shortage could render approval moot because it curtails the availability of the combo. Then there are indications ImmunityBio isn't ready for a potential launch. The company has not disclosed any plans on how to market Anktiva and no local partners to help in their respective territories. If they decide to go it alone to monopolize earnings, they have no sales force or other commercial infrastructure in place.