INOVIO Reports Fourth Quarter 2021 and Year-End Financial Results

INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help protect people from infectious diseases and help treat people with cancer and HPV-associated diseases, today reported financial results for the quarter and year ended December 31, 2021. INOVIO`s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO`s website.

Dr. J. Joseph Kim, President and CEO of INOVIO, said, "COVID-19 represents a continued and persistent threat to the health of our global community. The highly transmissible Omicron variant underscores the ongoing challenge to improve access to both primary vaccines and boosters. In in vitrotesting we observed that INO-4800 maintained robust T cell responses against the Omicron variant, even though we saw significantly decreased levels of both neutralizing and binding antibodies against Omicron, consistent with the vaccines of other developers. Based on these preserved T cell responses, INOVIO plans to seek approval to amend the primary endpoint of the INNOVATE Phase 3 trial to prevention of severe disease. INOVIO is also evaluating the feasibility of conducting an additional heterologous boost trial for INO-4800, which, if undertaken, would complement the booster trial underway with INOVIO`s partner Advaccine in China."

"In parallel with our COVID-19 efforts, we are also pleased with the clinical progress to date across our DNA medicines platform, including our therapeutic programs in HPV-associated diseases. In the fourth quarter, we completed enrollment of REVEAL2, our second global Phase 3 clinical trial of VGX-3100 for cervical pre-cancer. In addition, we recently completed enrollment in our Phase 1/2 clinical trial for INO-3107, our DNA immunotherapy for the rare disease recurrent respiratory papillomatosis (RRP), which received orphan drug designation from the U.S. FDA. We have also completed enrollment in a Phase 1b trial for Lassa fever, a Phase 1b trial for an Ebola vaccine booster, as well as the first part of our Phase 2 trial for Middle East Respiratory Syndrome (MERS), showcasing the depth and breadth of our DNA medicines pipeline to support global public health efforts against potential pandemic threats," said Dr. Kim.

INOVIO 4Q21 and Year-End 2021 Highlights:

• INO-4800 was observed to provide full maintenance of T cell responses, but significantly decreased levels of antibodies against the Omicron variant in line with results observed with other COVID-19 vaccines.
• INOVIO plans to seek regulatory approval to amend the primary endpoint of the INNOVATE Phase 3 trial from prevention of virologically confirmed COVID-19 disease to prevention of severe disease due to COVID-19. INOVIO has paused enrollment in INNOVATE in preparation for this potential change.
• The Company is evaluating the feasibility of pursuing an INOVIO-sponsored heterologous boost non-inferiority clinical trial with INO-4800 compared to viral vector and inactivated COVID-19 vaccines.
• INOVIO`s partner Advaccine completed enrollment of its 200-participant homologous and 267-participant heterologous boost trial with INO-4800 in China.
• INO-4800 was selected by the World Health Organization (WHO) for inclusion in a global Phase 3 trial for COVID-19 (Solidarity Trial Vaccines).
• REVEAL2, the second of two Phase 3 trials for VGX-3100 for cervical high-grade squamous intraepithelial lesions (HSIL), completed enrollment, with top-line efficacy and safety data anticipated in the second half of 2022.
• INOVIO completed enrollment of its Phase 1/2 trial of INO-3107 for RRP.
• Enrollment completed for the Phase 1b heterologous booster clinical trial of INO-4201 as a potential Ebola booster vaccine in collaboration with GuardRX and Geneva University Hospitals, an effort funded by the Defense Advanced Research Projects Agency (DARPA).