INOVIO Reports Fourth Quarter 2020 and Year-End Financial Results
INOVIO (NASDAQ: INO), a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today reported financial results for the quarter ended December 31, 2020. INOVIO`s management will host a live conference call and webcast at 4:30 p.m. Eastern Standard Time today to discuss financial results and provide a general business update, including: top-line efficacy data from REVEAL 1, a Phase 3 clinical trial of VGX-3100; a progress update for the company`s INNOVATE Phase 2/3 COVID-19 vaccine clinical trial and its development strategy regarding the new COVID-19 vaccine addressing the current and future COVID variants of concern (VOC); and a general update on its DNA medicines platform. The live webcast and a replay may be accessed by visiting INOVIO`s website at http://ir.inovio.com/events-and-presentations/default.aspx.
INOVIO Fourth Quarter and Year-End 2020 Highlights
- On March 1, 2021, INOVIO announced that it met primary and secondary efficacy endpoints among all evaluable subjects for the REVEAL 1 (Randomized Evaluation of VGX-3100 and Electroporation for the treatment of Cervical HSIL) trial. This trial is one of two ongoing pivotal, randomized, double-blind, multi-center, placebo-controlled, Phase 3 trials evaluating the safety, tolerability and efficacy of VGX-3100 to treat HPV-16/18-associated cervical high-grade squamous intraepithelial lesions (HSIL) using the company`s proprietary CELLECTRA® 5PSP device.
- In first quarter 2021, INOVIO completed enrollment of 400 subjects in the Phase 2 segment of the INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy) Phase 2/3 clinical trial.
- INOVIO is addressing the new COVID variants through evaluating the impact of newly circulating strains of the SARS-CoV-2 virus on the immune profile of the INO-4800 vaccine and developing next-generation, pan-COVID vaccine candidates whose design could potentially provide better protection against the known and currently unknown SARS-CoV-2 variants.
- In December, Phase 1 peer-reviewed clinical data from the first cohort of 40 participants administered with INO-4800 was published in The Lancet`s EClinicalMedicine.
- In November, INOVIO presented overall survival at 18 months (OS18) data from its novel combination trial of INO-5401 and INO-9012 in combination with PD-1 inhibitor Libtayo® at the Society for Neuro-Oncology (SNO) 2020 Annual Meeting. Median overall survival among the unmethylated Glioblastoma Multiforme (GBM) patients in the trial was 17.9 months, which compares favorably to historical controls.
Dr. J. Joseph Kim, INOVIO`s President and CEO, said, "We have had a productive fourth quarter across our DNA medicines platform, including significant developments within both our HPV and oncology programs. We presented encouraging clinical efficacy results in a landmark combination trial for INO-5401 in GBM at the SNO 2020 Annual Meeting last November. Most importantly, we announced that our REVEAL 1 Phase 3 clinical trial for VGX-3100 met primary and secondary endpoints among all evaluable subjects. We are truly proud to advance VGX-3100 as the first DNA medicine to reach this important milestone."
"INOVIO recognizes and applauds the incredible work to address the global COVID-19 pandemic across the industry, while also acknowledging the need for continued collaboration and coordination in vaccine development, manufacturing, and distribution. I am also extremely proud of the dedication and efforts of our INOVIO team in contributing to this global endeavor, grateful for the continued support of our partners, and thankful for all Phase 2 participants in our INNOVATE clinical trial for their help in the ongoing fight against the pandemic. We look forward to successfully completing our Phase 2 segment in the second quarter and seeking to advance to the Phase 3 portion of the trial."