Shares of INOVIO (NASDAQ: INO) were down over 23% on Tuesday, a day after the company reported second quarter 2020 earnings results that failed to impress investors. The firm also provided an update on its COVID-19 vaccine candidate. INOVIO’s stock has jumped over 341% since the beginning of this year and 13% over the past three months.
Quarterly results
Total revenues almost doubled year-over-year to $267,000 but fell short of projections. Net loss widened to $0.83 per share from $0.30 per share last year, also missing estimates. Operating expenses increased 18% to $33.4 million.
COVID-19 vaccine
INOVIO reported positive data from its Phase 1 clinical trial in the US for INO-4800, its COVID-19 vaccine. The trial was done on 40 participants aged 18-50, enrolled into 1 mg and 2 mg dose cohorts. INO-4800 was safe and well-tolerated in all participants in both cohorts. The Phase 1 trial was recently expanded with 80 additional participants and the extension was fully enrolled by mid-July.
INOVIO has received significant funding from government and private sources in the first half of 2020 to support vaccine development and manufacturing expansion. This includes $71 million from the Department of Defense.
“We believe our DNA medicines are ideally suited to safely drive robust immune responses across infectious diseases and cancer, and we look forward to publishing our latest INO-4800 data, starting our Phase 2/3 COVID-19 clinical study in the U.S. in September, and expanding the manufacturing capacity to produce at least 100 million doses of INO-4800 in 2021 via our growing global coalition of partners and funders.” – Dr. J. Joseph Kim, President and CEO
INOVIO expanded its INO-4800 DNA manufacturing agreement with Richter-Helm and CEPI to support large-scale manufacturing. The company is looking forward to advancing INO-4800 into a Phase 2/3 trial in September and meeting its target to provide at least 1 million doses of its DNA vaccine this year and 100 million doses in 2021.
INOVIO is also working to expand its manufacturing alliance. INO-4800 does not require frozen shipping or storage and the vaccine is stable for a year at room temperature and has a five-year projected shelf life when refrigerated. The formulation consists of optimized DNA plasmids and contains no lipid nanoparticles or adjuvants, which leads to better stability and tolerability.
The company is finalizing additional manufacturing partnerships in the US and Europe to fulfil its production goals and hopes to reveal more about its manufacturing alliance in the coming months.
Pipeline
INOVIO presented positive interim data from its Phase 1/2a trial for its DNA vaccine INO-4700 for the coronavirus MERS-CoV that causes Middle East Respiratory Syndrome. The company is preparing for a Phase 2 clinical trial to begin in the Middle East later this year.
INOVIO presented positive 12 months data demonstrating an 85% survival rate for its DNA immunotherapy INO-5401 to treat glioblastoma multiforme. The company plans to report 18-month overall survival data in the fourth quarter of this year.