Iovance Biotherp Stock Price, News & Analysis

Iovance Biotherapeutics (NASDAQ: IOVA) announced the publication of clinical data and trial designs for its tumor infiltrating lymphocyte (TIL) therapies at the ESMO Congress 2022 in Paris, from September 9-13, 2022. Two key abstracts were presented: Abstract #844P on the efficacy of lifileucel in advanced melanoma and Abstract #883TiP detailing a study on PD-1 inactivated TIL. These advances are part of Iovance's commitment to developing TIL therapies aimed at transforming cancer treatment.

Iovance Biotherapeutics has initiated a rolling Biologics License Application (BLA) submission for lifileucel, a T cell-based therapy targeting advanced melanoma. This marks a significant step toward offering the first individualized, one-time cell treatment for patients with limited options. With no current FDA-approved therapies in this setting, Iovance's submission is anticipated to be completed by Q4 2022. The BLA is bolstered by positive clinical data from the C-144-01 trial, and the FDA has designated lifileucel as a regenerative medicine advanced therapy.

Iovance Biotherapeutics (NASDAQ: IOVA) reported its second quarter and first half 2022 results, highlighting a net loss of $99.3 million, or $0.63 per share, compared to $81.4 million, or $0.53 per share, in Q2 2021. The company is on track to submit its first Biologics License Application (BLA) for lifileucel in metastatic melanoma, having received favorable FDA feedback. Cash reserves stand at $430.9 million, sufficient to fund operations into 2024. Increased expenses in R&D and G&A are attributed to team growth and pre-commercial activities, reflecting ongoing development in their TIL therapy pipeline.

Iovance Biotherapeutics (NASDAQ: IOVA) will release its second quarter financial results on August 4, 2022. The company is focused on developing innovative T cell-based cancer therapies, particularly its lead product candidate, lifileucel, for metastatic melanoma. This therapy aims to be the first approved one-time cell treatment for solid tumors. Management will conduct a conference call to discuss the results, with listeners able to participate via registration. Further information is accessible on Iovance's investor relations website.

Iovance Biotherapeutics has granted inducement stock options totaling 39,400 shares to 15 new non-executive employees as of July 21, 2022. These options, part of the 2021 Inducement Plan, have an exercise price of $12.52, matching the closing stock price on the grant date. The options will vest over three years, with one-third vesting on the first anniversary of employment and the remainder in eight quarterly installments, contingent on continued employment. Iovance aims to lead in T cell-based therapies for cancer, particularly with lifileucel for metastatic melanoma.

Iovance Biotherapeutics approved the grant of 68,225 inducement stock options to 14 new non-executive employees on June 16, 2022. These options were issued under the 2021 Inducement Plan with an exercise price of $8.13, equal to the stock's closing price on the grant date. The options will vest over three years, with one-third vesting on the first anniversary of each employee's start date. This initiative aligns with Iovance's strategy to attract talent in the competitive biotechnology sector.

Iovance Biotherapeutics (NASDAQ: IOVA) announced the appointment of Wendy L. Dixon, Ph.D., to its Board of Directors, effective June 10, 2022. Dr. Dixon brings over 40 years of experience in the biopharmaceutical industry, having launched more than 20 major pharmaceutical products. Chairman Iain Dukes highlighted her track record in commercial leadership, essential as Iovance prepares to submit its first Biologics License Application (BLA). Dr. Dixon expressed enthusiasm for contributing to Iovance's pipeline innovation and TIL therapy, which aims to address unmet cancer treatment needs.

Iovance Biotherapeutics (NASDAQ: IOVA) announced its senior leadership will present at several upcoming conferences in June 2022. Key events include the Jefferies Healthcare Conference on June 9, the JMP Global Healthcare Conference on June 15, and the Goldman Sachs Global Healthcare Conference on the same day. Additionally, they will participate in the Stifel Virtual Cell Therapy Conference on June 29. Live and archived webcasts will be available on their investor calendar. Iovance focuses on developing T cell-based immunotherapies for cancer, particularly its lead product candidate, lifileucel.

On May 26, 2022, Iovance Biotherapeutics reported clinical results from its C-144-01 study for advanced melanoma patients. In Cohort 4 (n=87), the objective response rate (ORR) was 29% with three complete responses and 22 partial responses, demonstrating the potential of lifileucel therapy in heavily pre-treated patients. Median duration of response for Cohort 4 was 10.4 months. A Biologics License Application (BLA) for lifileucel is planned for submission in August 2022. The company emphasizes the significance of these results as a new treatment option for patients with unmet medical needs.