Inovio Pharmaceuticals (NSDQ:INO) shares dipped after hours today after the company presented its fourth-quarter earnings and touted clinical trial results.
INO shares finished the day up 4.5% at $11.60 per share but have since dropped -2.2% after hours to $11.35 per share.
The Plymouth Meeting, Pa.-based company posted losses of -$24.3 million, or -14¢ per share, on sales of $5.6 million for the three months ended Dec. 31, 2020, for a 35.5% bottom-line gain on massive sales growth from revenues of just $279,000 in the fourth quarter of 2019.
Inovio’s EPS of -14¢ came in 8¢ ahead of Wall Street projections, while the $5.6 million in sales blew analysts’ projections of $1.1 million out of the water. The company did not offer financial guidance for 2021.
Additionally, the company touted results from the Reveal 1 Phase 3 clinical trial for its VGX-3100 in treating HPV-16/18-associated cervical high-grade squamous intraepithelial lesions (HSIL) using the company’s proprietary Cellectra 5PSP device.
Among 193 patients in a modified intention to treat population, the study observed 23.7% response to VGX-3100 in the treatment group versus 11.3% response in the placebo group, highlighting statistical significance, according to a news release.
All secondary efficacy endpoints — regression of cervical HSIL to normal tissue combined with HPV-16/18 viral clearance, regression of cervical HSIL alone, regression of cervical HSIL to normal tissue and HPV-16/18 viral clearance alone — were met.
In an intention to treat group with a population of 201, including subjects with missing endpoint data, 22.5% of subjects met the primary endpoint in the treatment group versus 11.1% in the placebo group, which was not statistically significant.
The missing endpoint data was a result of one subject being randomized but never dosed, one withdrawal due to pregnancy, one withdrawal due to administration error, one withdrawal due to post-administration pain, one loss of follow-up due to COVID-19-related travel restrictions and three losses of follow-up due to undetermined reasons.
There were no treatment-related serious adverse events, while most adverse events were self-resolving and were considered to be mild-to-moderate, consistent with earlier trials.
Inovio is currently following subjects in the Reveal 1 trial while enrolling subjects in a Reveal 2 study.
“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,” Inovio president & CEO J. Joseph Kim said in a news release containing the company’s quarterly earnings. “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.”
The company this year has also completed enrollment of 400 subjects in the Phase 2 segment of its Phase 2/3 clinial trial for the INO-4800 COVID-19 vaccine candidate.
“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 Inivio team in contributing to this global endeavor, grateful for the continued support of our partners, and thankful for all Phase 2 participants in our Inovio 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.”
