Basic data (GAAP):

Revenue was $0.2 million, down sequentially from $1 million, and down from $0.4 million in the year-earlier quarter. Revenue is from research collaborations and grants.

Net income was negative $79 million, up sequentially from negative $107 million, and down from negative $54 million year-earlier.

EPS (earnings per share, diluted) was negative $0.36, up sequentially from negative $0.50, and down from negative $0.27 year-earlier.

Guidance:

Has cash to support activities for multiple years.

Quarter Highlights:

Dr. Kim is out, the new CEO is Dr. Jacqueline Shea.

Dr. Jacqueline [Jackie] Shea, Inovio's CEO said, "We believe in the potential of our DNA medicines and vaccines to combat infectious diseases, cancer and HPV-associated diseases. To achieve these goals, INOVIO must strategically prioritize our resources to capitalize on its demonstrated ability to generate functional T-cell and antibody immune responses, lack of anti-vector response, tolerability for re-administration and favorable temperature stability for transport, storage and distribution."

In Q4 2021, on November 9, Inovio received FDA clearance to proceed with the Phase 3 covid vaccine trial in the U.S. But In May 2022 Inovio announced it would instead focus on its heterologous booster strategy. Partner Advaccine reported positive T cell immune response with INO-4800 as a booster. Conducting non-inferiority trials while discussing with national regulators.

Reveal 2 trial of VGX-3100 for cervical HSIL completed enrollment in December 2021, with topline data expected before the end of 2022. However, based on FDA feedback that Reveal2 study would not support approval, Inovio plans to amend the fully enrolled Reveal2 trial to revise the primary analysis population from the all-comers population to the biomarker-positive population. Both the biomarker-positive population and the all-comers population will be analyzed. It will continue its Reveal2 trial to completion and assess the path forward for the VGX-3100 program following analysis of the Reveal2 results. Given the likelihood for at least one additional trial, Inovio no longer expects to submit a BLA in 2023 for VGX-3100.

In Q4 2021 enrollment completed in the Phase 1B Lassa fever trial of INO-4500.

Focussing resources on pipeline priorities.

INO-4802 is a second-generation Covid 19 vaccine. Preclinical results look good.

INO-3107 completed enrollment in a Phase 1/2 trial for treatment of recurrent respiratory papillomatosis (RRP), a rare disease cause by HPV. Preliminary data expected before the end of 2022.

INO-5401 plus INO-9012 for newly diagnosed glioblastoma multiforme (GBM) two year survival data was presented at SITC, Q4 2021. More data will be presented in the ASCO abstract on May 26, 2022.

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 $360 million, down sequentially from $401 million.

R&D expense was $56 million. General and administrative expense was $16 million. Total operating expenses were $72 million. Operating profit negative $72 million. Interest and other expense $5 million.

Q&A summary:

VGX-3100 powering of trial? Biomarker is to identify the population where we can ensure efficacy. The biomarker has been in developing. The current trial should have enough power in the biomarker population.

Heterologous booster path forward? This pathway has been evolving rapidly, we have been in discussion with a number of regulatory authorities. We are seeing more arguments for heterologous boosting. We will need a safety database, discussing with regulators on the size of that database.

Thermo-fisher remains a key manufacturing partner.

We expect our cash burn rate to decrease, we will provide updates when available.

Heterologous endpoint? Prevention of severe Covid is becoming more important. Non-inferiority of humeral response is the current standard, but we are having discussions with regulators.