INOVIO, 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 June 30, 2021.

The total revenue was US $ 273,000 for the three months ended June 30, 2021, compared to US $ 267,000 for the same period in 2020. Total operating expenses were US $ 83.5 million compared to US $ 33.4 million for the same period in 2020.

INOVIO's net loss for the three months ended June 30, 2021, was $82.1 million, or $0.39 per basic and diluted share, compared to net loss of $128.7 million, or $0.83 per basic and diluted share, for the three months ended June 30, 2020. 

Research and development ("R&D") expenses for the three months ended June 30, 2021, were US $ 70.8 million compared to US $ 22.4 million for the same period in 2020. The increase in R&D expenses was primarily attributable to manufacturing scale-up activities for INO-4800. These INO-4800 activities included the acquisition and installation of manufacturing equipment, drug manufacturing, outside services and clinical study expenses. Other increases included engineering services and expensed equipment related to our CELLECTRA 3PSP device array automation project, employee and contractor compensation and drug manufacturing expenses related to our RRP trial. These increases were offset by an increase in contra-research and development expense recorded from grant agreements of US $ 8.1 million, among other variances.

Dr. J. Joseph Kim, President and CEO of INOVIO, said, "With COVID-19 rates surging again globally and an increasing number of breakthrough infections, INOVIO recognizes the need for additional safe and effective first-line vaccines, particularly those which could offer potential boosting capabilities, to combat the spread of the virus and emerging variants, including the rapidly spreading delta variant. INO-4800's ability to generate CD8 T cells are important to mitigating against variants of concern, including the delta variant. Findings from a study using clinical samples showed that INO-4800 maintained a robust T cell level against the delta variant when compared to T-cell responses from the original wildtype strain. These findings further complement our previously published Phase 1 and 2 trial data for INO-4800.

 As a reminder, the key advantages of INOVIO's DNA medicines platform include the ability to generate a balanced immune response that includes engagement of both T cells and B cells, coupled with a favorable transport, thermostability, and tolerability profile. These advantages continue to be integral to our ongoing discussions with countries expected to participate in the global INNOVATE Phase 3 trial for INO-4800, some of which are also considering INO-4800 for both clinical trials and the eventual emergency use authorization (EUA)."

Dr. Kim continued, "In parallel with our global INNOVATE Phase 3 trial, we continue to prepare INOVIO's next-generation, pan-COVID vaccine candidate, INO-4802, in a Phase 1/2 trial entitled IMPACT (INOVIO INO-4802 Multi-variant Pan-COVID-19 Vaccine Trial), where the goal is to induce cross-reactive immune responses against current and emerging viral variants as either a first-line vaccine, or as a boost."