Basic data (GAAP):

Revenue was $0.3 million, flat sequentially from $0.3 million, and up from $0.2 million in the year-earlier quarter. Revenue is from research collaborations and grants.

Net income was negative $60 million, up sequentially from negative $82 million, and down from $19 million year-earlier.

EPS (earnings per share, diluted) was negative $0.29, up sequentially from negative $0.39, and down from $0.11 year-earlier.

Guidance:

Has cash to support activities for multiple years.

Quarter Highlights:

Dr. J. Joseph Kim, Inovio's CEO said, "With much of the world still requiring broader access to vaccines, INO-4800 is particularly well-positioned to address global vaccine needs, having been shown, in clinical trials to-date, to be well-tolerated and to generate balanced immune responses which comprise both T and B cell engagement. In addition, INO-4800 has demonstrated a favorable thermostability profile that could facilitate global distribution. I am pleased to share that the dosing for INNOVATE Phase 3 segment is underway and we aim to have interim efficacy data in the first half 2022."

In Q4 2021, on November 9, Inovio received FDA clearance to proceed with the Phase 3 covid vaccine trial in the U.S. In Q3 2021 Inovio and Advaccine received Chinese regulatory approval to conduct 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.

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 for cervical HSIL expected to complete enrollment by the end of 2021. On March 1, 2021, Inovio had announced positive topline results from Reveal 1 Phase 3 study of VGX-3100 for cervical dysplasia, for both primary and secondary efficacy endpoints. Full results at a conference later in 2021. 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 is 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 should become available next week 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 $395 million, down sequentially from $444 million.

R&D expense was $47 million. General and administrative expense was $13 million. Total operating expenses were $60 million. Operating profit negative $60 million. Interest and other expense $1 million.

Q&A summary:

Lifting of partial clinical hold? That does not change our strategy that much. The huge unmet need is global. Authorizations from India, Thailand, Brazil, Columbia and the Philipines show the need.

If positive Phase 3, booster strategy? Phase 1 did have an optional booster. Safety and tolerability were favorable. With Phase 3, will be the 2 dose regimen. Once we establish efficacy, as we follow subjects, we will look at the booster setting. In China 4800 is being evaluated as a heterologous booster, so could be used with other primary vaccines.

Columbia agreement? First of many for advanced market commitment contracts to share our technology. Their outreach was positive and constructive.

Moderna IP v. government issue? We have received DOD funding for devices, but we believe the IP belongs to us.

The partial hold, particularly related to the device, was just in the U.S. The device was not a problem in the other nations. Dosing is underway. If is event driven, we are looking for 150 lab-confirmed cases. It will depend on the attack rates in the nations where the trial is run. So broadly in the first half of 2022. The WHO is conducting their trial separately, with multiple brands of vaccines.

INO-3107? Could have early data in 1H 2022.