Inovio reports Q2 EPS (13c), consensus (19c)
Reports Q2 revenue $20.4M, consensus $16.29M.In June, Inovio commenced its phase 3 clinical program to evaluate the efficacy of Inovio's DNA-based immunotherapy, VGX-3100, to treat cervical dysplasia caused by human papillomavirus (HPV). Initiating Inovio's first phase 3 program marks a significant milestone for the company, for the next generation of DNA-based immunotherapies, and for women's health. In the phase 3 trial, Inovio will assess the efficacy of VGX-3100 in regressing cervical HSIL (high-grade squamous intraepithelial lesions; also called CIN2 or CIN3), a direct precursor to cervical cancer, and in eliminating the HPV infection that causes these lesions. The pivotal data from this program, if positive, could support the licensure of VGX-3100 as the first immunotherapy for this disease. HPV is the most common sexually transmitted infection, with over 14 million new infections annually. Inovio satisfied the FDA's request for information relating to its CELLECTRA(R) 5PSP delivery device, resulting in the FDA removing a previously imposed clinical hold on this program. During the hold period, Inovio prepared investigational sites for the phase 3 study, resulting in the company opening 27 sites in just over the first month since the hold was removed. Inovio is on track to open at least 50 sites by the end of the year.