Basic data (GAAP):

Revenue was $1 million, up sequentially from $0.3 million, and up from $ million in the year-earlier quarter. Revenue is from research collaborations and grants.

Net income was negative $107 million, down sequentially from negative $60 million, and down from negative $24 million year-earlier.

EPS (earnings per share, diluted) was negative $0.50, down sequentially from negative $0.29, and down from negative $0.14 year-earlier.

Guidance:

Has cash to support activities for multiple years.

Quarter Highlights:

Dr. J. Joseph Kim, Inovio's CEO said, "In parallel with our COVID-19 efforts, we are also pleased with the clinical progress to date across our DNA medicines platform, including our therapeutic programs in HPV-associated diseases. In the fourth quarter, we completed enrollment of REVEAL2, our second global Phase 3 clinical trial of VGX-3100 for cervical pre-cancer. In addition, we recently completed enrollment in our Phase 1/2 clinical trial for INO-3107, our DNA immunotherapy for the rare disease recurrent respiratory papillomatosis (RRP), which received orphan drug designation from the U.S. FDA. We have also completed enrollment in a Phase 1b trial for Lassa fever, a Phase 1b trial for an Ebola vaccine booster, as well as the first part of our Phase 2 trial for Middle East Respiratory Syndrome (MERS), showcasing the depth and breadth of our DNA medicines pipeline to support global public health efforts against potential pandemic threats."

In Q4 2021, on November 9, Inovio received FDA clearance to proceed with the Phase 3 covid vaccine trial in the U.S. But enrollment in INO-4800 trial has been paused to amend the primary endpoint to prevention of severe disease. In Q1 2022 Inovio and Advaccine completed enrollment in two clinical trials to combine INO-4800 with Sinovac sequentially, and with CoronoVac. Using a 2.0 mg dose for the Phase 3 global trial [2 doses one month apart] which is approved to proceed in seven nations. The WHO is also conducting a Phase 3 covid trial that includes INO-4800.

In Q4 2021 enrollment completed in the Phase 1B Lassa fever trial of INO-4500.

In Q3 the first patient was dosed in a Phase 2 trial of INO-4700 for MERS.

INO-4802 is a second-generation Covid 19 vaccine. Preclinical results look good.

Reveal 2 trial of VGX-3100 for cervical HSIL completed enrollment in December 2021, with topline data expected before the end of 2022. On March 1, 2021, Inovio had already announced positive topline results from Reveal 1 Phase 3 study of VGX-3100 for cervical dysplasia, for both primary and secondary efficacy endpoints. Later Reveal 1 data showed longer term efficacy. Reveal 2 continued enrollment. BLA submission still possible in 2021. Each trial will enroll 198 patients. Inovio has a collaboration and license agreement providing ApolloBio Corporation with the exclusive right to develop and commercialize VGX-3100 within Greater China. A Phase 2 study of VGX-3100 for HPV related vulvar neoplasia (VIN) continued. An anal dysplasia [high-grade squamous intraepithelial lesions (HSIL)] Phase 2 continued and is cosponsored by the AIDS malignancy consortium with both HIV positive and negative patients. In January 2021 reported positive results for Phase 2 trial of vulvar HSIL. Plans to apply for Orphan Drug status. Plans to discuss Phase 3 trial options for anal and vulvar dysplasia with FDA.

INO-3107 completed enrollment in a Phase 1/2 trial for treatment of recurrent respiratory papillomatosis (RRP), a rare disease cause by PPV.

INO-5401 for newly diagnosed glioblastoma multiforme (GBM) two year survival data was presented at SITC, Q4 2021.

Inovio also has a variety of other vaccines in clinical or preclinical study. See the Inovio Pipeline for an overview.

Cash and equivalents balance ended at $401 million, up sequentially from $395 million.

R&D expense was $92 million. General and administrative expense was $14 million. Total operating expenses were $106 million. Operating profit negative $ million. Interest and other expense $ million.

Q&A summary:

VGX-3100 FDA discussions? Qiagen is continuing to advance biomarker development. Hope to identify most likely responders; encouraged by progress to date. Engaging with FDA for biomarker path.

If Covid protocol amendment? Omicron has changed things with reduction in antibody responses from original vaccine. Our Omicron data shows maintains t cell responses. We believe we will have a stong position once we get the Phase 3 data.

4800 timeline? Steps to amending primary endpoint is in each country, hope will occur expediently. We think we have a strong case. We do not expect to change the trial size.

3100 timeline? Fully enrolled Reveal2. 40 week follow up. So preliminary data in Q4 2022.

4800 sample size with Omicron? We are powering to 90%, with higher Omicron incidence likely to compensate for lower rate of severe disease.

We expect burn per quarter to run in the $65 million range.

MERS vaccine trial could report data by Q3 2022.