Basic data (GAAP):

Revenue was $5.6 million, up sequentially from $0.24 million, and up from $0.3 million in the year-earlier quarter. Revenue is from research collaborations and grants.

Net income was negative $24.3 million, down sequentially from negative $19 million, and up from negative $37.7 million year-earlier.

EPS (earnings per share, diluted) was negative $0.14, down sequentially from negative $0.11, and up from negative $0.38 year-earlier.

Guidance:

Cash sufficient for multiple years.

Quarter Highlights:

Dr. J. Joseph Kim, Inovio's CEO said, "We have had a productive fourth quarter across our DNA medicines platform, including significant developments within both our HPV and oncology programs. We presented encouraging clinical efficacy results in a landmark combination trial for INO-5401 in GBM at the SNO 2020 Annual Meeting last November. Most importantly, we announced that our REVEAL 1 Phase 3 clinical trial for VGX-3100 met primary and secondary endpoints among all evaluable subjects. We are truly proud to advance VGX-3100 as the first DNA medicine to reach this important milestone. Inovio recognizes and applauds the incredible work to address the global COVID-19 pandemic across the industry, while also acknowledging the need for continued collaboration and coordination in vaccine development, manufacturing, and distribution. I am also extremely proud of the dedication and efforts of our Inovio team in contributing to this global endeavor, grateful for the continued support of our partners, and thankful for all Phase 2 participants in our INNOVATE clinical trial for their help in the ongoing fight against the pandemic. We look forward to successfully completing our Phase 2 segment in the second quarter and seeking to advance to the Phase 3 portion of the trial."

The Phase 2 portion of the trial of INO-4800 for Covid-19 completed enrollment of its 400 subjects in Q1 2021. The trial should complete in Q2 2021. Looking at how to address new virus variants. In December 2020 clinical data from the Phase 1 study had been reported in The Lancet.

Abstract, "INO-5401 and INO-9012 delivered intramuscularly (IM) with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma" was accepted as a late-breaking presentation at the 24th Annual Scientific Meeting the Society for Neuro-Oncology. Presentation was made November 20, 2020. In Q2 2020 Inovio reported positive interim data from its ongoing Phase 2 trial of newly diagnosed GBM (glioblastoma multiforme), which combines Inovio's INO-5401 and INO-9012, in combination with Libtayo, a PD-1 blocking antibody produced by Regeneron Pharmaceuticals in collaboration with Sanofi.

On March 1, 2021 announced positive topline results from Reveal 1 Phase 3 study of VGX-3100 for cervical dysplasia. 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. Plans to report the data from AIN and VIN Phase 2 clinical trials in the fourth quarter of 2020. Plans to apply for Orphan Drug status.

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

MedImmune MEDI0457 (was INO-3112) combined with durvalumab, a PD-L1 inhibitor, for HPV-associated head and neck squamous cell carcinoma enrollment completed the Phase 2 trial early in Q3 2019. Also expanding to test for other HPV-associated cancers in a separate Phase 2 patient in Q1 2019. One head and neck patient achieved full remission. In December 2019 announced a second Phase 2 study of MEDI0457 with with durvalumab targeting a broad array of cancers associated with HPV. MedImmune has also selected MEDI0457 combined with durvalumab to treat a HPV cancer other than head and neck, with a third Phase 2 initiation milestone payment made in Q2 2019. MedImmune is a division of AstraZeneca.

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 $412 million, up sequentially from $338 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 $26.3 million. General and administrative expense was $8.6 million. Total operating expenses were $34.9 million. Operating profit negative $28 million. Interest and other expense $na million.

Q&A summary:

INO-4800 Phase 3, could it include boosters, variants? We are looking at 4800 and ten other covid vaccines. Moving along pan-Covid vaccine as rapidly as possible. The FDA guidance is helpful for planning.

INO-4800 funding include buying of doses? We have received funding for Phase 2 and 3 from the DOD. Also for the delivery device and a few hundred thousand doses for the DOD. Those paid dose numbers could be increased as the program progresses.

INO-4800 timeline details? Q2 will be busy. Expect Phase 2 topline data in early part of Q2. Device submissions in Q2. The FDA has 30 days to concur or not with plan. So could move forward in the later part of Q2.

VGX-3100? We are looking forward to bring this product out. Surgery is the only option now. Modified intent to treat and ITT were both prespecified endpoint, the differences were announced for completeness. They are assessed in total.

VGX-3100 durability? In Phase 2 responders there were no recurenced of viral infection, and no Pap smear regression.

VGX-3100 biomarkers? Aiming for a biomarker with a high level of predictability for responding.

Anal and vulvar biomarker? No decision made on that yet, but we hope to have more info as we go along.

For variants, would you need new Phase 1 trials? Per FDA guidance so far and our safety profile, we think we can more rapidly. We should have data from our booster study and from variants in Q2.

Reveal 2 timing for VGX-3100? Enrollment was hampered by the pandemic. Not providing guidance on finish data yet, but now back to pre-pandemic recruiting levels. Enrollment characteristics were similar, but 2 is more geographically varied.