Basic data (GAAP):

Revenue was $0.3 million, down sequentially from $0.4 million, and flat from $0.3 million in the year-earlier quarter. Revenue is from research collaborations and grants.

Net income was negative $82 million, down sequentially from negative $54.4 million, and up from negative $129 million year-earlier.

EPS (earnings per share, diluted) was negative $0.39, down sequentially from negative $0.77, and up from negative $0.83 year-earlier.

Guidance:

Has cash to support activities for multiple years.

Quarter Highlights:

Dr. J. Joseph Kim, Inovio's CEO said, "As a reminder, the key advantages of Inovio's DNA medicines platform include the ability to generate a balanced immune response that includes engagement of both T cells and B cells, coupled with a favorable transport, thermostability, and tolerability profile. These advantages continue to be integral to our ongoing discussions with countries expected to participate in the global INNOVATE Phase 3 trial for INO-4800, some of which are also considering INO-4800 for both clinical trials and the eventual emergency use authorization (EUA)."

In Q3 2021 Inovio and Advaccine received Chinese regulatory approval to conduct two clinical trials to comine INO-4800 with Sinovac sequentially, and with CoronoVac.

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

The U.S. government decided not to finance the Phase 3 trial for INO-4800. Will use a 2.0 mg dose for the Phase 3 global trial which will begin this summer. Already working on a next-generation variant, 4802.

INO-4500 for Lassa fever dosed its first patient in a Phase 1b trial in Q1 2021 in Ghana. It is the first vaccine o enter human human trials in the indication.

On March 1, 2021 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 in Q4 2021.

In Q1 2021 Inovio entered into a collaboration and license agreement for INO-4800 with Advaccine, who will have the exclusive right to develop, manufacture and commercialize INO-4800 within Greater China, which includes Mainland China, Hong Kong, Macao, and Taiwan. Advaccine will license its plasmid manufacturing process for use with INO-4800 and other Inovio pipeline product candidates to Inovio with the right to sublicense to Inovio's manufacturing partners. Inovio received an upfront payment of $3.0 million and is eligible to receive up to an aggregate of $108.0 million upon the achievement of specified development and sales-based milestones for INO-4800 in Greater China. Inovio is entitled to receive a royalty equal to a high single-digit percentage of annual net sales in each region within Greater China.

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 $444 million, down sequentially from $516 million.

R&D expense was $71 million. General and administrative expense was $13 million. Total operating expenses were $83 million. Operating profit negative $83 million. Interest and other expense $ million.

Q&A summary:

Increase in cases, variants, effects on trial enrollment? Starting in Latin America and Asia-Pacific, will also start in Africa, given its low vaccination rates.

Glioblastoma path? Still tracking the Phase 2 patients for 24 month results, to be presented in a Q4 conference. We wil have further discussions with regulators.

INO-4800 Phase 3 will happen in 2021. Was designed against wild type, so far it has held up against the new variants. We are encouraged by that data. We are getting data from 3 continents, making enrollment decisions in real time.

Yes, we have seen women prefer HSIL treatment over surgical, particulary because it can affect future pregnancies. VGX-3100 could be first non-surgical based treatment for the disease and virus. Reveal 2 should fully enroll before the end of 2021, data should be available in 2022. Patients now face the choice of surgery or potentially developing cancer. We are very confident in the approvability of the delivery device.

The Covid trial enrollments should complete this year with data readouts in first half of 2022. [If I heard right]. First dosing in September.

Zydus' vaccine results are encouraging for the DNA vaccines field. There were some differences: they used 3 doses and a different delivery mechanism.