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The biotech firm posted a loss of $0.18 per share, wider than consensus estimates of about a $0.08 per-share loss.
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Anktiva combined with BCG met the primary goal of a Phase 3 trial in BCG-Naïve NMIBC
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Israel became the 35th country to approve Anktiva Plus BCG for BCG-Unresponsive NMIBC with Carcinoma in Situ with or without papillary tumors.
ImmunityBio (IBRX) shares crashed nearly 19% on Monday as investors weighed the biotech firm’s weaker-than-expected third-quarter earnings, despite positive results from a late-stage bladder cancer trial and another international approval for its flagship treatment, Anktiva.
IBRX shares slumped to their lowest levels in nearly nine months. The stock is also on track to decisively break below the crucial 200-day moving average (200-DMA) for the first time since January.
Q3 Revenue And Earnings Miss Estimates
ImmunityBio reported Q3 revenue of $48.8 million, sharply below Wall Street’s estimate of $59.2 million, according to Fiscal.ai. This was its first topline miss in six quarters. The company also posted a loss of $0.18 per share, wider than consensus estimates of about a $0.08 per-share loss.
ImmunityBio said the net loss was mainly driven by changes in the fair value of a related-party convertible note, and warrant and derivative liabilities due to an increase in the stock price, higher R&D and general and administrative expenses. It ended September with $334.3 million in cash, cash equivalents and marketable securities.
Anktiva + BCG Meets Phase 3 Trial Goal
Separately, the retail-favorite biotech firm announced that Anktiva combined with BCG met the primary goal of its Phase 3 Quilt-2.005 trial involving 370 patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC). The trial evaluated patients receiving BCG, a standard bladder cancer treatment, for the first time.
The combination showed a statistically significant improvement in treatment response compared with BCG alone in patients with carcinoma in situ, a form of early-stage bladder cancer. ImmunityBio plans to seek FDA approval for the expanded indication by year-end.
ImmunityBio also announced approval of Anktiva plus BCG in Israel for patients with BCG-Unresponsive NMIBC with Carcinoma in Situ with or without papillary tumors. The approval expands Anktiva’s reach to 35 countries.
Retail Sees Downside Until Q2 2027
While retail sentiment surrounding IBRX on Stocktwits improved to ‘neutral’ from ‘bearish’ over the past 24 hours, users highlighted the disappointing earnings.