Basic data (GAAP):

Revenue was $388 thousand, up sequentially from $226 thousand, and down from $9.2 million in the year-earlier quarter. Revenue is from research collaborations and grants.

Net income was negative $33.9 million, up sequentially from negative $35.5 million, and up from negative $37.8 million year-earlier.

EPS (earnings per share, diluted) was negative $0.13, flat sequentially from negative $0.13, and up from negative $0.15 year-earlier.

Guidance:

Cash runway to end of Q2 2025. Q4 2023 cash burn $26 million.

Quarter Highlights:

Dr. Jacqueline [Jackie] Shea, Inovio's CEO said, "The past quarter has seen significant progress for our lead candidate, INO-3107, for the treatment of Recurrent Respiratory Papillomatosis, or RRP. Following Breakthrough Therapy designation from the FDA in September and subsequent feedback that we no longer need to complete a Phase 3 trial prior to submitting a BLA under the accelerated approval program, our team is laser-focused on next steps. These steps include holding an Initial Comprehensive Multidisciplinary Breakthrough Therapy Meeting with the FDA in the near future to confirm alignment on our accelerated development plans and to clarify timing associated with potentially making INO-3107 available to patients suffering from this devastating disease. The progress we have achieved with INO-3107 exemplifies the strategy we have been implementing over the past year, as we have focused on advancing late-stage candidates and driving toward near, mid- and long-term milestones for our pipeline. In the past 18 months, we have reshaped our company, reduced our operating spend and reprioritized our pipeline with INO-3107 as our lead candidate. I am more confident than ever that our experienced team is prepared to deliver on the next critical steps of development and on the promise of DNA medicine for patients."

Closer than ever on bringing DNA based medicines to the U.S. markets. Continues to work on restructuring the organization.

The INO-3107 Phase 3 trial for RRP should begin in Q1 2024. The FDA granted Breakthrough Therapy designation in September 2023. FDA said will not require completion of a Phase 3 trial for submission of the BLA based on Phase 2 data under the accelerated approval program. Will also request a rolling review and priority review. But additional FDA meetings are necessary. Inovio has begun making commercial preparations to be ready if approval is granted, with a focus on laryngologists. Believe payers will treat INO-3107 as a specialty therapy. Believes there are about 14 thousand active RRP cases in the U.S.

On May 5, 2023, data from the Phase 1/2 trial of INO-3107 for RRP (Recurrent Respiratory Papillomatosis) were presented at American Broncho-Esophagological Association (ABEA) at the Combined Otolaryngology Spring Meetings (COSM) in Boston, Massachusetts. The presentation highlighted the safety profile of INO-3107, which was well tolerated by participants in the trial and resulted in mostly low-grade (Grade 1) treatment-emergent adverse effects (TEAEs). There were no high-grade TEAEs deemed related to treatment and no TEAEs leading to treatment discontinuation. Treatment with INO-3107 induced cellular immune responses against both HPV-6 and HPV-11, with activated CD4 and CD8 T cells, including cytotoxic CD8 T cells thought to be important for clearance of virally infected cells. Preliminary analysis indicates a potential correlation between T-cell responses and reduction of surgeries: 26 of 32 patients showed reduced surgical interventions. T-cell responses were also observed at Week 52, indicating a persistent cellular memory response. A positive EU orphan drug designation was aunnounced in May 2023. Inovio plans to meet with EU authorities to discuss further development. Has had favorable FDA feedback for the Phase 3 trial.

Pending discussions with regulators, Inovio plans to investigate opportunities to advance VGX-3100 as a potential treatment for anal HSIL, an indication that continues to have significant unmet need.

Inovio is also working to advance its oncology product candidates, INO-5401 and INO-3112, which target glioblastoma (GBM) and HPV-related cancers, respectively; other candidates in its early-stage clinical pipeline targeting infectious diseases; and the Ebola vaccine candidate, INO-4201. Progress for these candidates has continued in the areas of manufacturing, regulatory submissions, and partnership discussions. The next stage of clinical development will most likely require additional funding or partnerships.

Outlined three step process for DNA medicines: start with INO-3107 approval; then 8 additional clinical stage targets; then next generation DNA medicines including dMAbs (dna coded monoclonal antibodies).

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 $168 million, down sequentially from $195 million.

R&D expense was $16 million. General and administrative expense was $10 million. Goodwill impairment $11 million. Total operating expenses were $26 million. Operating profit negative $36 million. Interest and other income $2 million.

Q&A selective summary:

RRP BLA outstanding items, timing? We have been working to accelerate our timeline, put together a detailed package for next FDA meeting. Want agreement on what should be in BLA. Will rely on some data from 3100 program, like the device. We need Phase 3 protocol alighnment so we can start that trial and then submit the BLA.

Commercial costs v. runway? The FDA discussion will clarify the timeline. Because it is a rare disease the number of sales call points is small. We are set to manufacture. 300 to 400 laryngologists perform a majority of the RRP surgeries in the U.S. We have started working with payers. We plan to operating efficiently.

Patients redosed in trial? There is no antivector response, so we know redosing can be done. But we did not redose any patients in the study. Some patients had complete responses, some had very good partial responses, but some did not respond much. Redosing would not likely be in the label. We believe the value proposition is strong for payers. Some patients have hundreds of surgeries over their lifetimes.

Redosing in Phase 3 trial? Talking with FDA about that.