Edit for the traders

Short interest 29%, 49 million shares, 18 days to cover. For traders, this is set-up equals a perfect storm.

EDIT TODAY 9-9-2024

ImmunityBio Presents Positive Long-Term Overall Survival Data in Non-Small Cell Lung Cancer Patients and Announces Registrational Intent Phase 3 Trials with ANKTIVA® and Checkpoint Immunotherapy at World Conference on Lung Cancer

• Phase 2 data presented at the World Conference on Lung Cancer showing a prolonged median overall survival of over 14 months in 2^nd and 3^rd line NSCLC cancer patients who progressed on checkpoint inhibitors such as KEYTRUDA (pembrolizumab) and OPDIVO (nivolumab)
• ANKTIVA plus KEYTRUDA or OPDIVO rescued T cell activity in these patients who progressed on the same checkpoint inhibitor with overall survival of 57% at 12 months
• Long-term survival was independent of PDL1 tumor status and independent of 2^nd or 3^rd line of therapy
• The data continues to validate the mechanism of action of ANKTIVA in activating NK, CD8 killer, and Memory T cells resulting in prolonged overall survival in patients with advanced cancers
• Data supports global launch of Phase 3 randomized control of ResQ trials of ANKTIVA plus KEYTRUDA or OPDIVO in 1^st and 2^nd line NSCLC (ResQ301 and ResQ302) versus standard of care

8/9/2024

Bio Investments can be extremely risky. Once in a while we see a unique company pursuing unique science with massive potential.

• Immunity Bio's Anktiva a new blockbuster
  • ANKTIVA, developed by ImmunityBio, has received FDA approval for use in combination with BCG (Bacillus Calmette-Guérin) to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This drug leverages the immune system, particularly by stimulating natural killer (NK) cells and T cells, to fight cancer, offering a promising new treatment option for patients who previously faced invasive surgery
  • ANKTIVA is also being investigated for multiple other conditions, including various solid tumors, non-Hodgkin's lymphoma, non-small-cell lung cancer, and HIV
• Immunity Bio Finances at a glance
  • ImmunityBio is experiencing deficit and cash-flow challenges, according to the filing. As of June 30, the company had an accumulated deficit of $3.2 billion. It also had negative cash flows of $207.3 million during the six months ended June 30.
  • The company also said in the filing that it believes there is substantial doubt about its ability to continue without additional funding. However, it went on to note that its existing cash, cash equivalents and investments in marketable securities; sales of approved product; capital to be raised through equity offerings; and potential ability to borrow from affiliated entities will fund operations through at least 12 months.
• Understanding the CEO
  • Soon-Shiong's net worth is $6.2 billion as of 2024. He has been called the richest man in Los Angeles and one of the wealthiest doctors in the world.
  • Soon-Shiong purchased Fujisawa, which sold injectable generic drugs, in 1998. He used its revenues to develop Abraxane, which took an existing chemotherapy drug, Taxol, and wrapped it in protein that made it easier to deliver to tumors. He was able to quickly move it through the regulatory process and made his fortune with this medicine
    • https://en.wikipedia.org/wiki/Patrick_Soon-Shiong#References
• ImmunityBio Strategic partnership in India.
  • Collaboration will result in BCG manufacture at large scale for use in combination with ANKTIVA®, ImmunityBio’s recently approved treatment for non-muscle invasive bladder cancer (NMIBC)
  • Serum Institute of India (SII) will manufacture both standard BCG (“sBCG”) and next-generation recombinant BCG (“iBCG”), creating a long-term solution to chronic BCG supply shortage issues
• Next indication approval
  • ImmunityBio Announces Positive Overall Survival Results of Anktiva Combined With Checkpoint Inhibitors in Non-Small Cell Lung Cancer; Meeting Scheduled with FDA to Discuss Registration Path for ANKTIVA in Lung Cancer
    • QUILT 3.055 trial completed and shows median overall survival almost double that of standard of care chemotherapy in 2^nd– and 3^rd-line non-small cell lung cancer (NSCLC) patients whose cancer did not respond to checkpoint inhibitors with or without chemotherapy.
    • Positive results seen in both PD-L1 negative and PD-L1 positive participants with NSCLC
    • Data reaffirms the mechanism of action of ANKTIVA as an immune cell enhancer that activates natural killer (NK) cells and memory T cells to rescue checkpoint inhibitor (pembrolizumab, nivolumab, atezolizumab) failures across multiple tumor types
• Presentation TODAY (08/09/2024)
  • Results: The median OS (n=86) was 14.1 months (95% CI 11.7, 17.4) with 24 ongoing survival to date. In 3^rd line+ve (n=25) median OS was 14.8 months (95% CI 9.1, 26.7). OS for PDL1+ve (>1%) (N=53) was 13.8 months (95% CI 10.2, 17.4) versus PDL1-ve (N=33) blah blah blah……… https://cattendee.abstractsonline.com/meeting/20598/Session/142Conclusions: Anktiva plus CPI therapy in 2nd line or greater NSCLC demonstrated long-term median OS, independent of PDL1 status, and independent of prior lines of therapy in patients with acquired resistance to CPI. These findings support the novel mechanism of action of Anktiva to rescue CPI activity through the activation of NK and T cells, driving long-term memory, with median OS ongoing survival of 33% and 30% at 18 and 21 months respectively, exceeding the standard of care.
• Conclusion (or my opinion)
  • IBRX has in Dr. Soon a business man that knows how to invest and get returns. It is likely IBRX will have all rights to USA/North America – but will partner with Big Pharma (J&J, Astra or so) for EMEA region. Looking at his previous businesses, I assume he will do the same once again. Sell/partner at the right moment. Estimated sales is 900 million p/a by 2028. That is for 1 indication only.
  • A partnership will likely alter the balance sheet of IBRX, see an upfront payment and milestone payments too.
    • Part of my thesis is UK approval. While Europe approvals take time, UK approval is easier. due to the International Reliance Procedure [7]. If the MHRA decides to take this road for approving Anktiva, then (at least theoretically) a UK approval could be a fact within 2024………… And guess where the plane of the Dr. has been this month? Yes, Heathrow.