What happened
Shares of Iovance Biotherapeutics (IOVA +1.97%) were up by more than 14% late Monday afternoon. There were two factors that brought the clinical-stage biotech company's shares up Monday. The first was a counterpoint to the company's shares reaching a 52-year low on Friday at $5.28 a share. The other is the company's release of its annual report on Thursday, which gives investors more clarity about its plans for promoting its lead therapy. Iovance focuses on T-cell-based immunotherapy technology platforms to treat various solid tumors and blood cancers.
NASDAQ: IOVA
Key Data Points
So what
Investors like a bargain, and considering the potential for Iovance, the prospect on buying the stock on the dip was too difficult to pass up for many investors. In March, Iovance completed its biologics license application (BLA) for lifileucel as a treatment for patients with advanced melanoma who have already had anti-PD-1 therapy. The company said it expects to hear back from the FDA regarding the BLA this month. If approved, it would be the first approved therapy for this indication and the first experimental tumor infiltrating lymphocycte (TIL) therapy approved for a solid tumor.
It's important to note that Iovance, for a clinical-stage company, has an active pipeline with 18 programs. Beyond lifileucel, it also has high hopes for LN-145 as a monotherapy and combination therapy for non-small cell lung cancer (NSCLC) and as a treatment for cervical cancer.
Now what
iovance has no revenue yet, and last year, it lost $395.9 million, or $2.49 per share. As of Feb. 24, it said it had $669.8 million in cash, likely enough to fund operations into 2025. A lot is riding on the company receiving approval for lifileucel. That's not a given considering the FDA delayed the company's BLA submission for the therapy twice before this. Last November, the company said the delay was due to the agency's request for additional data on the drug. The BLA submission was also delayed in May of 2021 as the FDA asked for more data regarding Iovance's potency assays for lifileucel.
