Basic data (GAAP):

Revenue was $0.8 million, up sequentially from $0.2 million, and up from $0.3 million in the year-earlier quarter. Revenue is from research collaborations and grants.

Net income was negative $108 million, down sequentially from negative $79 million, and down from negative $82 million year-earlier.

EPS (earnings per share, diluted) was negative $0.46, down sequentially from negative $0.36, and down from negative $0.39 year-earlier.

Guidance:

Has cash to support activities to Q3 2024.

Quarter Highlights:

Dr. Jacqueline [Jackie] Shea, Inovio's CEO said, "During the second quarter, we focused on reshaping our organizational structure to help us achieve our product development goals. These efforts included strengthening our executive and R&D teams by appointing Dr. Michael Sumner as our Chief Medical Officer and extending our cash runway into the third quarter of 2024 through cost-savings measures and a corporate restructuring effort. During the quarter we also focused on advancing our strategies for those programs that have the greatest potential to deliver DNA medicine technology to the market. Those programs include our heterologous booster program for our COVID-19 vaccine candidate, INO-4800, as well as our HPV-associated programs. We were also encouraged by positive Phase 1/2 data presented at ASCO involving INO-5401, when used in combination with PD-1 inhibitor, Libtayo, against glioblastoma. With several additional pipeline milestones expected over the next several months, I look forward to sharing our progress in advancing our DNA medicines towards commercialization in the second half of 2022."

Focussing resources on pipeline priorities. That allowed it to reduce the workforce in Q2 by 18% and contractors by 86%. Op ex expected to decline by about 30% over the next 18 months. There will be a restructuring charge of $1.6 million in Q3.

In May 2022 Inovio announced it would instead focus on its heterologous booster strategy for its Covid vaccine. 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, 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.

In June 2022 Inovio announced additional results from a Phase 1/2 trial involving INO-5401 and INO-9012 at ASCO. INO-5401 + INO-9012 was observed to have favorable tolerability and immunogenicity results when administered with Libtayo and RT/TMZ (radiation and temozolomide) to newly diagnosed glioblastoma brain cancer patients. Notably, INO-5401 + INO-9012 elicited antigen-specific T cells that may infiltrate GBM tumors.

INO-4802 is a second-generation Covid 19 vaccine. Preclinical results look good. Work on 4800 continues as well. Waiting for final analysis on the heterologous booster trial, expected in late Q3.

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 plus Libtayo for newly diagnosed glioblastoma multiforme (GBM) two year survival data was presented at SITC, Q4 2021. Data was presented in the ASCO abstract on May 26, 2022. Survival data compares well to historical controls.

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 $348 million, down sequentially from $360 million.

R&D expense was $56 million. General and administrative expense was $48 million. Total operating expenses were $105 million. Operating profit negative $104 million. Interest and other expense $4 million.

Part of G&A expense was non-cash for planned issuance of stock in settlement of class action securities litigation. Also $6.9 million cash for severance of former CEO. In Q3 expects a $73 million cash burn, which will decline in following quarters.

Q&A summary:

INO 4800 commercial opportunity at this point? Heterologous boosters provide advantages over other vaccine types. It elicits cellular responses against multiple variants of concern. Tolerability is important.

3107 for RRP? Focus is on advancing this and other advanced candidates.

5401 next steps? Pleased with ASCO data. Discussing with Regeneron the path forward.

Market sizes for MERS, Ebola, Llassa fever? Will provide program updates later this year. These diseases are important, stockpiles may be created.

Continuing discussion with regulators in select countries for 4800. No disclosure yet.