Basic data (GAAP):

Revenue was $103 thousand, down sequentially from $388 thousand, and down from $125 thousand in the year-earlier quarter. Revenue is from research collaborations and grants.

Net income was negative $25 million, up sequentially from negative $33.9 million, and up from negative $54 million year-earlier.

EPS (earnings per share, diluted) was negative $1.10, down sequentially from negative $0.13, and up from negative $2.61 year-earlier.

There was a 12:1 reverse stock split after the quarter ended on January 24, 2024.

Guidance:

Has cash to last into Q2 2025.

Quarter Highlights:

Dr. Jacqueline [Jackie] Shea, Inovio's CEO said, "The past year has been transformative as we have reshaped Inovio into a company that is focused on commercializing its first product candidate and bringing the benefits of DNA medicine to patients. We focused on the strengths of our platform and our strategic objectives: advancing candidates with scientific promise, achievable pathways to market, and strong commercial potential, while maintaining an ongoing commitment to financial discipline and operational excellence. In the past year we have taken our lead candidate, INO-3107 for RRP, from positive Phase 1/2 trial results to Breakthrough Therapy designation and an established path to BLA submission under the FDA's accelerated approval program. We've also announced a new clinical collaboration and supply agreement with Coherus BioSciences to advance our development of INO-3112 in combination with Loqtorzi (toripalimab-tpzi) for throat cancer, shared encouraging results for INO-4201 as an Ebola vaccine booster, continued to advance other clinical-stage candidates, and progressed important preclinical research opportunities. The year ahead will provide a critical opportunity to carry this positive momentum forward across our pipeline, particularly for INO-3107 as we prepare for BLA submission and the initiation of a confirmatory trial in the second half of 2024 and accelerate commercialization efforts for a potential 2025 launch."

Closer than ever on bringing DNA based medicines to the U.S. markets. Could submit the BLA for INO-3107 for RRP in 2024. Continues to work on restructuring the organization.

The INO-3107 Phase 3 trial for RRP should begin in 1H 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.

In January 2024 announced a collaboration with Coherus BioSciences to combine INO-3112 with Loqtorzi for high risk HPV positive oropharyngeal squamous cell carcinoma (throat cancer). Coherus will provide free Loqtorzi, a PD-1 inhibitor, for a Phase 3 trial.

Inovio is also working to advance its oncology product candidates, INO-5401 and INO-3112, which target glioblastoma (GBM) and HPV-related cancers, respectively. 5401 Phase 1/2 data is being finalized. The Ebola vaccine candidate, INO-4201, data from the Phase 1b trial was positive and now in discussions with FDA on future steps.. 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 $144 million, down sequentially from $168 million. In Q1 2024 expects $26 miillion regular cash burn plus $17 million repayment on convertible senior notes.

R&D expense was $17 million. General and administrative expense was $10 million. Goodwill impairment $0 million. Total operating expenses were $28 million. Operating profit negative $28 million. Interest and other income $3 million.

Q&A selective summary:

Confirmatory Phase 3 trial timeline, etc.? For BLA submission, finalizing Phase 3 field details with FDA. Will update when we know sample size, etc. Believes plenty of potential patients.

RRP KOSs, surgery cost, pricing of therapy? RRP is rare, expect rate disease pricing.

3107 scale of manufacturing? Models are we can meet all demand quickly. Because it is a rare disease we should be able to build out the launch inventory.

Believes the Phase 3 3112 study can serve as a registration study. Working with FDA on design and path to BLA.

Most resources are focussed on 3107, but are looking for funds for rest of pipeline, and some preclinical work requires minimal spend.

Any KOL pushback so far on 3107? We have had multiple advisory boards. Working with RRP Foundation. Physicians want an alternative to surgery, which does not address the underlying condition. Even surgeons think there should be a non-surgical treatment. Also easy to identify patients because of the impact of the disease.