Basic data (GAAP):

Revenue was $0.4 million, down sequentially from $5.6 million, and down from $1.3 million in the year-earlier quarter. Revenue is from research collaborations and grants.

Net income was negative $54.4 million, down sequentially from negative $24.3 million, and down from negative $32.5 million year-earlier.

EPS (earnings per share, diluted) was negative $0.77, down sequentially from negative $0.14, and up from negative $0.26 year-earlier.

Guidance:

Cash sufficient for multiple years. First to clinical trial with a Lassa vaccine.

Quarter Highlights:

Dr. J. Joseph Kim, Inovio's CEO said, "As the global community continues to contend with the Covid-19 pandemic, and as we prepare for endemic considerations to support the continued fight against variants, Inovio remains well-positioned to address the global demand for Covid-19 vaccines. We recognize that there is an opportunity to have a meaningful impact in the fight against Covid-19 outside the U.S. and, are planning for a global Phase 3 trial for INO-4800. Inovio is also encouraged by the positive data from the Phase 2 segment of our Phase 2/3 trial of INO-4800, which is being conducted in the United States. INO-4800 continues to be safe and well-tolerated and has been observed to support the body's ability to generate both robust neutralizing antibodies and T cell responses, which we believe to be essential in protecting against current and emerging variants of concern. Equally important, INO-4800 has a favorable thermostability profile and does not require cold or ultra-cold chain transport." Is in talks with several nations about advance purchase agreements.

The U.S. government will not finance the Phase 3 trial for INO-4800. The Phase 2 portion of the trial of INO-4800 for Covid-19 completed enrollment of its 400 subjects in Q1 2021. Positive preliminary Phase 2 data was released on May 10, 2021 and posted as a preprint. Worked against all current variants. 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. Reveal 2 continued enrollment. BLA submission still possible in 2021. Two phases each 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 later in 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 $516 million, up sequentially from $412 million. On January 25, 2021, the Company closed a public offering of 20,355,000 shares of common stock at a price of $8.50 per share, raising $162.1 million.

R&D expense was $39 million. General and administrative expense was $14 million. Total operating expenses were $53 million. Operating profit negative $53 million. Interest and other expense $2 million.

Q&A summary:

Clinical hold on Covid Phase 3? The ex-US strategy is not affected by the partial clinical hold in the US. However, we plan to open sites in the U.S. We plan to submit to lift the hold in Q2. But most Phase 3 patient will come from outside the US.

Reveal 1 full safety and efficacy data is due this year.

Do you have to update the filing for Phase 3 for the 2.0 dose? Only 5% of the global population has received a Covid vaccine so far. Inovio is drafting submissions for the 2.0 Phase 3 in each country. We are working with an experienced CRO, including in the nations we are using.

DOD funding discontinuation, impact on perception of the vaccine? We were surprised. They had not seen our Phase 2 trial data before making a decision. It was about vaccines in the US, not our data. We thank the DOD for funding Phase 2 and the prep work for Phase 3. We may have other potential funders.

3107 RP? Got orphan drug designation last year. Phase 1/2 trial is ongoing. Meaningful data not likely until 2022.

DNA vaccines, we believe, can be boosted over and over with great tolerability and no anti-vector response.