Iovance Biotherp Stock Price, News & Analysis

Iovance Biotherapeutics announced positive FDA feedback on April 1, 2022, regarding its potency assay matrix for the upcoming Biologics License Application (BLA) for lifileucel, a treatment for metastatic melanoma. With this feedback, Iovance plans to request a pre-BLA meeting in July 2022 and aims to submit the BLA by August 2022. In addition, the company will initiate a Phase III study of lifileucel combined with pembrolizumab, demonstrating a 67% overall response rate in prior trials. The FDA granted Fast Track Designation for this combination due to its potential advantages.

Iovance Biotherapeutics announced its participation in key healthcare conferences in March 2022. The schedule includes:

• Oppenheimer Healthcare Conference: Fireside Chat on March 16 at 12:40 p.m. ET
• Barclays Global Healthcare Conference: Fireside Chat on March 17 at 10:45 a.m. ET

Live and archived webcasts will be available on Iovance's investor calendar. The company is focused on pioneering T cell-based cancer immunotherapies, particularly lifileucel for metastatic melanoma.

Iovance Biotherapeutics (NASDAQ: IOVA) announced on March 14, 2022, the approval of inducement stock options and restricted stock units covering 667,725 shares to nineteen new non-executive employees. These awards were granted under the 2021 Inducement Plan, which complies with Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $12.38, and vesting occurs over three years. This initiative aims to attract talent to enhance Iovance's development of T cell-based cancer therapies, particularly its lead candidate, lifileucel, for metastatic melanoma.

Iovance Biotherapeutics announced that the FDA has approved an Investigational New Drug Application for IOV-4001, its first genetically modified TIL therapy, aimed at treating unresectable metastatic melanoma and stage III or IV NSCLC.

This therapy utilizes TALEN® gene-editing technology licensed from Cellectis to target the PD-1 protein, potentially improving T cell response against cancer. A clinical study is set to commence in 2022, marking a significant milestone in Iovance's TIL platform development.

Iovance Biotherapeutics (NASDAQ: IOVA) announced the acceptance of two abstracts for presentation at the AACR 2022 Annual Meeting, scheduled for April 8-13, 2022, in New Orleans, Louisiana, and virtually. The first abstract focuses on the preclinical activity of genetically modified PDCD-1 knockout TIL cell therapy, presented by Arvind Natarajan. The second abstract highlights a Phase 2 multicenter trial (IOV-LUN-202) of autologous TIL therapy in metastatic non-small cell lung cancer, presented by Jason Alan Chesney. Posters will be available from April 8 in the Virtual ePoster Hall.

Iovance Biotherapeutics reported its fourth quarter and full year 2021 results, highlighting continued advancements in TIL therapy for various solid tumors, notably melanoma and non-small cell lung cancer. The FDA granted fast track designation for lifileucel combined with pembrolizumab in metastatic melanoma. However, the company experienced a net loss of $99.3 million for Q4 2021 and $342.3 million for the full year, with rising R&D and administrative expenses. Iovance ended 2021 with a cash position of $602.1 million, projected to sustain operations into 2024.

Iovance Biotherapeutics announced the approval of stock options for 138,575 shares to nineteen new non-executive employees on February 17, 2022, under its 2021 Inducement Plan. The options, priced at $16.34 per share, will vest over three years, with one-third vesting on the first anniversary of each employee's start date. Iovance focuses on T cell-based cancer immunotherapy, aiming to deliver innovative treatments for solid tumors. The company’s lead candidate, lifileucel, shows potential to be the first approved one-time cell therapy for metastatic melanoma.

Iovance Biotherapeutics (NASDAQ: IOVA) will release its Q4 and full-year financial results on February 24, 2022, with a conference call at 4:30 p.m. ET. The company is focused on developing T cell-based cancer immunotherapies, particularly its lead product candidate, lifileucel, for metastatic melanoma, potentially becoming the first approved one-time cell therapy for solid tumors. The press release emphasizes ongoing innovation in cell therapy and highlights Iovance's commitment to improving cancer treatment.

Iovance Biotherapeutics announced the grant of 117,000 inducement stock options to 13 new non-executive employees as part of its 2021 Inducement Plan. The options were priced at $14.04, the closing stock price on January 21, 2022. Each option vests over three years, with one-third vesting on the first anniversary of the employee's start date and the remainder in quarterly installments. This action aligns with Nasdaq Listing Rule 5635(c)(4) and is part of Iovance's commitment to attract and retain talent in the field of cancer immunotherapy.