Basic data (GAAP):

Revenue was $115 thousand, down sequentially from $125 thousand , and down from $199 thousand in the year-earlier quarter. Revenue is from research collaborations and grants.

Net income was negative $40.6 million, up sequentially from negative $54.5 million, and up from negative $79.1 million year-earlier.

EPS (earnings per share, diluted) was negative $0.16, up sequentially from negative $0.22, and down from negative $0.36 year-earlier.

Guidance:

Has cash to support activities to Q1 2025.

Quarter Highlights:

Dr. Jacqueline [Jackie] Shea, Inovio's CEO said, "In the first quarter of 2023 we made solid progress with several key pipeline candidates, including important headway in our development plans for INO-3107, our DNA medicine candidate for the treatment of RRP (recurrent respiratory papillomatosis). From our ongoing discussions, we believe we are in alignment with the FDA on several critical design elements for our planned Phase 3 program for INO-3107, as we continue to work through a number of their questions. We were also encouraged to receive a positive opinion from the European Committee for Orphan Medicinal Products on our application for orphan drug designation for INO-3107. The final determination is now with the European Commission, which will decide on our application this month. We believe the committee's opinion is another step in the right direction for the development of this candidate on a global basis." Has been reducing the cash burn, which is a priority.

During the first quarter, Inovio shared topline results from REVEAL2, the second Phase 3 trial for VGX-3100 as a treatment for cervical HSIL. The trial results did not meet the primary endpoint in the biomarker-selected population, but the trial did achieve statistical significance in the all-participants population. Will provide detailed biomarker analysis in Q3 2023. Working with ApolloBio to continue development in China.

INO-3107 completed enrollment in a Phase 1/2 trial for treatment of recurrent respiratory papillomatosis (RRP), a rare disease cause by HPV. In Q2 2023 reported a strong immune response and statistically significant clinical benefit. 26 of 32 patients showed reduced surgical interventions. The final EU decision on orphan drug designation is expected in May 2023. Inovio plans to meet with EU authorities to discuss further development. Has had favorable FDA feedback for the Phase 3 trial.

The FDA had already indicated that at least one additional trial would be necessary for VGX-3100 for cervical HSIL.

Inovio has initiated discussions for further development of VGX-3100 for anal HSIL.

In Q2, 2023 presented data that INO-4201 is a potential booster for Ervebo for Ebola.

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 $224 million, down sequentially from $253 million.

R&D expense was $30 million. General and administrative expense was $14 million. Total operating expenses were $44 million. Operating profit negative $44 million. Interest and other expense $2 million.

Q&A selective summary:

3107 cohort differences? We are very encouraged by the data and our FDA interactions. We felt the 2 cohorts were very similar. Saw the same median decrease in surgeries.

Number of patients in Phase 3 trial? Size of market? Not disclosed trial size yet, but got statistical significance with small cohorts. Safety database may require a higher number, but overall should be very managable. Estimated 14,000 active RRP patients in the U.S., similar number in Europe. Current average cost of treatment in US is about $72,000 per year. We expect rate disease pricing for this high unmet medical need.

Anal HSIL? Very promissing Phase 2 results. Confident will see clearance of cells, but in discussions with agencies.

RRP can be a life-long disease. Really chronic. Disease course can be variable. Many people have it for decades. There are patients out there that have had hundred of surgeries.

We expect no problems with our electroporation device, FDA questions are routine.