Basic data (GAAP):

Revenue was $125 thousand, down sequentially from $9 million, and down from $839 thousand in the year-earlier quarter. Revenue is from research collaborations and grants.

Net income was negative $54.5 million, down sequentially from negative $38 million, and up from negative $106 million year-earlier.

EPS (earnings per share, diluted) was negative $0.22, down sequentially from negative $0.15, and down from negative $0.50 year-earlier.

Full year 2022 revenue was $10.3 million. Net loss was $280 million. EPS loss was $1.17.

Guidance:

Has cash to support activities to Q1 2025. Q1 2023 cash burn expected at $32 million.

Quarter Highlights:

Dr. Jacqueline [Jackie] Shea, Inovio's CEO said, "The last year has been one of transition for Inovio. We chose to make some difficult but essential decisions to best position our pipeline and organization for the future, and we are a stronger company because of it. We've honed our strategic vision, strengthened our financial position, and maintained our cash runway into first quarter 2025, enabling us to focus energy and resources on advancing candidates with scientific promise, achievable pathways to market, and strong commercial potential. Our continued commitment to financial discipline and operational excellence will guide us as we work to get those candidates across the finish line and ultimately deliver on the promise of DNA medicines for patients." Has been reducing the cash burn, which is a priority.

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 were later reported as positive. Full data will be presented in May at a medical conference.

Reveal 2 trial of VGX-3100 for cervical HSIL completed enrollment in December 2021, and topline data was reported on March 1, 2023. Missed the primary endpoint in the biomarker positive population. Achieved statistical significance in the all particpatns population. In the biomarker group 28.6% met the endpoint (lession regression), vs. 0% in the placebo group, with only 25 total in the biomarker group. In the larger 203 patient group (134 treated, 69 placebo), 27.6% met the endpoint, v. 8.7% in the placebo group. Another endpoint, viral clearance, had 37.3% positive in the treatment group. "This combined data set will be used as supportive data in future regulatory interactions involving VGX-3100." The FDA had already indicated that at least one additional trial would be necessary.

In February 2022 INO-4201, an Ebola booster vaccine, reported posive Phase 1b results, boosting humoral response in 100% of healthy adults.

INO-3112 results for HPV-related cancers were published in Clinical Cancer Research in 2023. Looking for a partner.

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 $253 million, down sequentially from $282 million.

R&D expense was $42 million. General and administrative expense was $14 million. Total operating expenses were $56 million. Operating profit negative $na million. Interest and other expense $na million.

Q&A selective summary:

The VGX-3100 encouraging take away is seeing viral clearance and lesion regression. The parts of the data that were statistically significant indicate we should continue.

Preclinical targets? The focus is on the medicines with a clear path to a significant market. For now the focus is on HPV-related diseases.

We are in discussions with regulators on the path for RRP. We will be making announcements in the coming months.

How were the biomarkers themselves tested? Was the trial underpowered? We used an investigational biomarker, we are not disclosing that signal yet. We did expect a higher number of patients to have the biomarker, but the real problem was lower efficacy in that population. We are continuing our analysis. The biomarker was applied retrospectively; we did not select patients using it.

As to cash burn, it will include the hoped-for Phase 3 RRP trial that could start towards the end of 2023.