ImmunityBio stock rises 27% on completing the regulatory filing process in the EU and the U.K. for the Anktiva/BCG combo to treat NMIBC CIS patients.
On Wednesday, ImmunityBio, Inc. IBRX released progress in its ongoing FDA discussions regarding three areas of its clinical development pipeline in non-muscle invasive bladder cancer (NMIBC) and non-small cell lung cancer (NSCLC).
ImmunityBio's recent $100M public offering was necessary to support ANKTIVA's commercialization and pipeline programs, despite the dilution and lower offering price of $3 per share. The company's cash burn rate and financial health remain concerns, but ANKTIVA's impressive performance and future milestones could drive substantial growth and extend the cash runway. IBRX's financial risks persist, and multiple offerings may be needed before profitability, but the potential for explosive revenue growth by 2029 supports a bullish outlook.
ImmunityBio's Anktiva shows promise with potential peak revenues of ~$900m annually, but faces significant competition and financial challenges, including a poorly timed $100m fundraising effort. Despite recent setbacks, including a Q3 net loss of $80m and a cash position of $130m, I maintain a "Buy" rating, anticipating positive 2025 catalysts. Anktiva's efficacy in NMIBC and potential in NSCLC + other cancers are potentially compelling, but the company needs substantial funding to complete ongoing and planned clinical studies.
The average of price targets set by Wall Street analysts indicates a potential upside of 184.4% in ImmunityBio (IBRX). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.
ImmunityBio (IBRX) came out with a quarterly loss of $0.14 per share versus the Zacks Consensus Estimate of a loss of $0.18. This compares to loss of $0.19 per share a year ago.
ImmunityBio's stock traded higher by 37% after dosing the first patient in its phase 1 QUILT 106 study for CD19+/CD20+ NHL, with data expected in 2025. The company's ANKTIVA therapy, combined with Keytruda or Opdivo, showed promising results in phase 2b for NSCLC, leading to upcoming phase 3 studies. The company has around $130.1 million in cash, bolstered by a $100 million infusion, enough to fund operations for at least the next 12 months.
ImmunityBio (IBRX) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.
EF Hutton has initiated coverage on ImmunityBio Inc. IBRX, a vertically integrated biotechnology company developing therapies and vaccines to bolster the natural immune system for cancers and infectious diseases.
ImmunityBio's ANKTIVA shows promising commercial and clinical progress, with expanded patient access and potential EU/UK regulatory filings, enhancing its global market penetration and revenue prospects. Recent positive clinical data for ANKTIVA in NSCLC and endometrial cancer trials highlight its potential beyond bladder cancer, boosting its long-term growth outlook. Despite significant advancements, risks include regulatory hurdles, commercialization challenges, high cash burn, and reliance on founder Dr. Patrick Soon-Shiong for funding.
Anktiva, ImmunityBio's lead molecule, shows promising results with a 71% CR rate and 100% survival at 24 months for BCG-unresponsive NMIBC. Despite Anktiva's potential, ImmunityBio faces financial challenges, relying heavily on loans from founder Dr. Soon-Shiong, leading to high indebtedness. The company has a market cap of $2.43bn but limited cash runway, raising concerns about its financial stability and lack of recent earnings calls.
ImmunityBio received FDA approval for ANKTIVA plus BCG for BCG-unresponsive bladder cancer in April. The drug has a unique mechanism of action. Immunity's early launch progress of Anktiva shows promising market access initiatives, but financial concerns remain due to high R&D costs. Analysts project peak revenues of ~$900m by 2028 for Anktiva, although at present, Immunity's pricing of the drug is a little hard to understand.