Inovio Reports Q4 Earnings Beat, Mixed REVEAL 1 Data And Coronavirus Vaccine Update

Inovio Pharmaceuticals Inc INO shares are lower in after-hours trading in reaction to multiple catalysts.

REVEAL 1 Study Reveals Mixed Results In Cervical Dysplasia: Inovio said a pivotal REVEAL 1 Phase 3 study of VGX-3100 in treating high-grade precancerous cervical dysplasia, caused by HPV-16 and/or HV-18 met primary and secondary endpoints among all evaluable subjects.

The trial is one of the two ongoing pivotal studies, evaluating the safety, tolerability and efficacy of VGX-3100 to treat HPV-16/18-associated cervical high-grade squamous intraepithelial lesions using the company's proprietary Cellectra 5PSP device.

Among the modified intention to treat population, the study achieved the primary endpoint of histopathological regression of HSIL combined with virologic clearance, with statistical significance. All secondary efficacy endpoints were also achieved.

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However, for the intention to treat population, comprising all randomized subjects regardless of availability of endpoint data, the percentage of subjects meeting the primary endpoint was not statistically significant.

On the safety front, the company said there were no treatment-related serious adverse events and most adverse events were self-resolving.

Inovio said it will continue to follow subjects in REVEAL 1 for safety and durability of response for 18 months following the last administration. The REVEAL 2 trial is currently enrolling.

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Inovio's Q4 Beats Estimates: Inovio reported fourth-quarter revenues of $5.6 million in 2020 compared to $279,000 in the year-ago quarter. Analysts, on average, estimated revenues of $1.11 million.

The net loss for the quarter was $24.3 million or 14 cents per share compared to a loss of $37.7 million or 38 cents per share for the year-ago quarter. The consensus had called for a loss of 22 cents per share.

As of Dec. 31, 2020, cash and cash equivalents and short-term investments were $411.6 million compared to $89.5 million as of Dec. 31, 2019.

Coronavirus Vaccine Update: Inovio said it completed enrollment of 400 subjects in the Phase 2 segment of the INNOVATE Phase 2/3 study that is evaluating its DNA vaccine, INO-4800, against SARS-CoV-2.

The company also said it's evaluating the impact of newly circulating strains of the SARS-CoV-2 virus on the immune profile of the INO-4800 vaccine. It's also developing next-generation, pan-COVID vaccine candidates that could be tailored to the known and potentially unknown SAR-CoV-2 variants.

In after-hours trading, Inovio shares were down 5.1% at $11.00. The stock closed the regular session higher by 4.5%.