Nantkwest / Immunitybio -> IBRX WKN: A2QQ2E ISIN: US45256X1037 Kürzel: IBRX Forum: Aktien User: captainpump97

QUILT 3.055 Median overall survival almost double that ofstandard of care chemotherapy in 2nd- and 3rd-line non-small celllung cancer (NSCLC) patients whose cancer did not respond tocheckpoint inhibitors with or without chemotherapy.•FDA meeting June 2024•Oral Presentation at the IASLC 2024 World Conference on LungCancer (WCLC) Sept 8, 2024•“IL-15 Superagonist (N-803, Anktiva) + Checkpoint Inhibitor (CPI)Prolongs OS in 2nd line or Greater NSCLC Patients Failing CPI”

Complete response rate of85% with BCG andANKTIVA versus 61% atany time•Duration of responsestatistically significant at 9months at 84% versus52%•Continued trend of longduration of response at 12,15, 18, 21 and 24 monthswhen ANKTIVA iscombined with BCG

Initiated Resources for Global Filing Utilizing FDA BLA Registration DocumentationGlobal Regulatory Filing•EMA Filing – 30 Countries (27 EU + 3 European Economic Area EEA)oInitial EMA Filing Submitted June 2024oFull EMA Submission Anticipated October 2024•Canada•United Kingdom•Other Regions in Discussion

1.Strong Cash Position•$100 MM Non-dilutive Cash Infusion May 2024•Approximately $260 MM Cash on Hand*•Commercial Launch on May 6th, 2024

Market Access and Reimbursement Readiness•Compendia filing completed and accepted•NCCN Guidelines updated to include ANKTIVA•Payor discussions initiated and in progress•Large healthcare groups discussions initiated and in progress•HCPCS code application submitted2.ImmunityBio Cares Patient Assistance Program Implemented•Assist Patients and Practices to navigate their benefits•Team of fully staff health care professionals, including nurses and case manager to support patients andUrology Practices•Assistance with benefits question and process, including Benefits and Preauthorization•Deploying ANKTIVA Co-Pay Assistance and Patient Assistance ProgramoCo-Pay Assistance can be as low as $100/doseoPatient Assistance Program offers free drug for patients based on their individual financial situation

one day delivery, 24 month shelf life, no special freezers, no special cleaning agents, no change in bcg workflow, same order flow as bcg

1.Concentrated Urology Practices•Discussions Initiated in the Past Year and Ongoing•Key Opinion Leaders (KOLs) Discussions2.Urology Practice Clinical Workflow•Identical Schedule of dosing to BCG•Identical Ordering as for BCG•Simple Admixture of ANKTIVA and BCG with no special equipment or processes different from BCGadministration•Administration for up to 37 months3.Urology Backoffice Ordering and Workflow•Coding and Reimbursement Consistent with Current Workflow•Pricing $35,800 per dose4.No Change to Urology Practice Required

So wie ich verstanden habe werden aber keine Verkaufszahlen genannt

Das Highlight zum Schluss 😉

3. Anktiva mechanism of action 4. A. Safety, efficienty and durability 5.quality of live 6.clinical data 7.bcg supply 8A. In NSCLC

2. global regulatory filing status

1. approval and commercial lunch

Jetzt kommt ein Business Update

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