NEW YORK – Iovance Biotherapeutics on Monday priced an underwritten public offering of common stock at $7.50 per share, which it expects to bring in gross proceeds of about $150 million.
The firm is selling 20,000,000 shares of its common stock and has also granted underwriters a 30-day option to purchase up to 3,000,000 additional shares of its common stock at the public offering price. Goldman Sachs and Jefferies are joint lead bookrunning managers for the offering, which is expected to close around July 13.
Iovance plans to use the funds to prepare for the commercial launch of its autologous tumor-infiltrating lymphocyte (TIL) therapy lifileucel, should the therapy garner approval from the US Food and Drug Administration later this year. The FDA recently accepted Iovance's biologics license application for lifileucel in advanced melanoma after a series of filing delays and roadblocks.
The San Carlos, California-based firm said it will also put the offering proceeds into its Philadelphia-based cell therapy manufacturing facility, the Iovance Cell Therapy Center.
Beyond the melanoma indication for lifileucel, for which Iovance is hoping to receive approval in late November, the firm is also developing autologous TIL therapies for treating non-small cell lung cancer and said in a separate announcement on Monday that it met with the FDA to discuss its plans. According to the firm, the agency said in that meeting that Iovance's ongoing Phase II trial, dubbed IOV-LUN-202, could provide data supporting an accelerated approval bid for the TIL therapy, called LN-145, in previously treated, advanced NSCLC. The firm plans to enroll roughly 120 patients with PD-1 immunotherapy-refractory disease onto the registrational trial by mid-2024.
Iovance said it has conducted a preliminary analysis of the ongoing lung cancer trial, in which 23 NSCLC patients have received the autologous TILs so far. Among treated patients, the overall response rate was 26.1 percent and the disease control rate was 82.6 percent. Durations of response ranged from 1.4 months to 9.7 months, though the median duration of response was not reached.
Looking ahead, Iovance said it also plans to meet with the FDA later this year to discuss a randomized clinical trial exploring LN-145 as a first-line advanced NSCLC treatment.
Given these ambitions, Iovance plans to use proceeds from the public offering to further advance these studies. It will also use the funds to study TILs in combination with immunotherapy, for example, in immune checkpoint inhibitor-naïve melanoma patients. Finally, Iovance will use the proceeds to integrate into its pipeline an interleukin-2 drug candidate that it acquired from the biotech Clinigen earlier this year and fund general corporate activities.