Basic data (GAAP):

Revenue was $9 million, up sequentially from $0.8 million, and up from $0.3 million in the year-earlier quarter. Revenue is from research collaborations and grants.

Net income was negative $38 million, up sequentially from negative $108 million, and up from negative $60 million year-earlier.

EPS (earnings per share, diluted) was negative $0.15, up sequentially from negative $0.46, and down from negative $0.29 year-earlier.

Guidance:

Has cash to support activities to Q1 2025.

Quarter Highlights:

Dr. Jacqueline [Jackie] Shea, Inovio's CEO said, "Inovio continues to implement its strategy of delivering the potential of DNA medicines to patients, focusing its resources on those candidates that have the greatest opportunity for near-term success. In the third quarter, Inovio announced positive Phase 1/2 data for INO-3107, a promising DNA medicine candidate as a potential treatment for recurrent respiratory papillomatosis. These results are exciting to us because they build upon our ongoing work indicating that DNA medicines have the potential to treat HPV-associated diseases. We are also encouraged by other candidates in our pipeline, such as INO-5401, which has also shown positive results this year as a potential treatment for glioblastoma. We look forward to continuing to advance these programs as well as other pipeline programs for which we continue to anticipate data announcements in the coming months. In the third quarter, we also continued our efforts to create a more focused company rooted in operational excellence and optimized capital and resource allocation. Our decision to discontinue our internally funded development of INO-4800 as a heterologous COVID-19 booster is in line with this strategy and we will deploy cost savings from this effort to the development of other promising candidates. We will also leverage the strengths and capabilities developed by our COVID-19 program across our portfolio, where appropriate, such as our new intradermal 3PSP investigational delivery device."

INO-3107 completed enrollment in a Phase 1/2 trial for treatment of recurrent respiratory papillomatosis (RRP), a rare disease cause by HPV. Interim results reported in Q3 2022 were postive and statistically significant. Results from the second cohort are expected in 1H 2023.

Discontinued the INO-4800 Covid vaccine program. However Advaccine will continue to develop INO-4800.

Reveal 2 trial of VGX-3100 for cervical HSIL completed enrollment in December 2021, and topline data had been expected before the end of 2022. However, based on FDA feedback that Reveal2 study would not support approval, Inovio amended the Reveal2 trial to revise the primary analysis population from the all-comers population to the biomarker-positive population. The amendments have been submitted and both the biomarker-positive population and the all-comers population will be analyzed. The last patient visit is slated for September 2022. 40 week data will be reported in late 2022 or early 2023. Given the likelihood the FDA will require for at least one additional trial of the biomarker-positive population, Inovio no longer has a timeline for the BLA submission.

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 $282 million, down sequentially from $348 million.

R&D expense was $33 million. General and administrative expense was $12 million. Total operating expenses were $45 million. Operating profit negative $36 million. Interest and other expense $2 million.

Q&A selective summary:

Potential trial for INO-3107? Excited about 3107 data. Believes a meaningful efficacy signal. New study will be designed to progress the regulatory strategy. Hope the FDA will see the next trail as a registrational study.

Op ex going forward? Not providing guidance, but numbers should continue to decrease.

VGX-3100 plans? Reveal 2 data should come in late in 2022 or in Q1 2023. Hoping for more clinical benefit in the biomarker population, above that in the general population.

Prioritizing the pipeline? Glioblastoma, HPV. Looking for focus on rapid clinical benefit. Our platform has proven it can produce specific T cell responses.

5401 going forward? Thinking about the next steps with Regeneron. Will provide an update next year.