If correct, 40+ million short. Which is quite interesting. FDA is in labeling discussions, they would not do so if they had no intention of progressing.
* **First Finance, as reported:**
* Iovance had $427.8 million in cash, cash equivalents, investments and restricted cash at September 30, 2023, compared to $478.3 million at December 31, 2022. The current cash position and anticipated revenue in 2024 from lifileucel and Proleukin® is expected to be sufficient to fund current and planned operations into 2025.
* Iovance has reached an exciting point in its growth story. Regulators are reviewing the company’s lead product, lifileucel for advanced melanoma, and are set to issue a decision on or before Feb. 24. The drug could bring in global sales of as much as $959 million in 2029
* **2024 Outlook**
* FDA Priority Review of Biologics License Application (BLA) on Track for Lifileucel in Advanced Melanoma with Prescription Drug User Fee Act Action (PDUFA) Date of February 24, 2024
* Positive Regulatory Feedback Supports Lifileucel Regulatory Submissions in Europe and Canada in 2024
* A look at their career section, implies all wheel are in motion. If approved of course.
* **Additional**
* TIL therapies include IOV-GM1-201 to investigate PD-1 inactivated TIL therapy (IOV-4001) in previously treated advanced melanoma or NSCLC as well as pivotal Cohort 2 in the ongoing C-145-04 trial of lifileucel to support a BLA in cervical cancer following progression on or after chemotherapy and pembrolizumab.
* A novel interleukin-2 (IL-2) analog (IOV-3001) is in Investigational New Drug (IND)-enabling studies supporting its use as part of the TIL treatment regimen following TIL infusion.
* Additional research and preclinical studies are exploring approaches to increase TIL potency using CD39/69 double negative TILs and stable gene incorporation enhancements such as tethered cytokines.
* **Typical Bio setback**
* On Dec 22, 2023, the FDA placed a clinical hold on the IOV-LUN-202 study following a grade 5 (fatal) serious adverse effect, potentially related to the non-myeloablative lymphodepletion pre-conditioning regimen observed in the study.
* Nuance: What is reported but under-reported, is the patient being very ill already and could not be helped by regular treatments. Articles from sites that deliver analysis almost always ignore this. The trial is halted, which the FDA is morally and ethically obliged to do. But, my guess, it will continue.
* **Concluding**
* Getting its melanoma program approved would be huge, as it’d mark THE FIRST APPROVAL of a cell therapy for a solid tumor indication. The company would start to make sales for the first time, and it might even be profitable by early 2025.
If approved, history is made. As to the effect on the stock, over time….
