Basic data (GAAP):

Revenue was $0 thousand, down sequentially from $103 thousand, and down from $115 thousand in the year-earlier quarter. Revenue is from research collaborations and grants.

Net income was negative $31 million, down sequentially from negative $25 million, and up from negative $41 million year-earlier.

EPS (earnings per share, diluted) was negative $1.31, down sequentially from negative $1.10, and up from negative $1.89 year-earlier.

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

Guidance:

Has cash to last into Q3 2025. Expects about $30 million cash burn in Q2 2024.

Quarter Highlights:

Dr. Jacqueline [Jackie] Shea, Inovio's CEO said, "In the first quarter of 2024, we continued to deliver on our priorities for the year. Of utmost importance, we remain on track to submit our BLA in the second half of 2024 under the accelerated approval pathway for INO-3107 as a treatment for RRP and are working to initiate our confirmatory trial as soon as possible based on feedback from the FDA on the trial's design. We are energized by the opportunity to potentially deliver the first FDA-approved therapy for this devastating disease and continue to work expeditiously to be prepared to serve RRP patients and the physicians caring for them. If approved, INO-3107 would also be the first DNA medicine on the market in the United States, representing a major milestone for our technology platform. In parallel, we also made progress with our plans to evaluate INO-3112 in combination with the PD-1 inhibitor, LOQTORZI, in a Phase 3 trial, as we believe the combination could address a substantial unmet need in patients with locoregionally advanced, high-risk, HPV-16/18 positive OPSCC, a type of head and neck cancer commonly known as throat cancer. We believe that we are aligned with the FDA on our proposed Phase 3 trial design, and we now plan to discuss these plans with European regulators. We look forward to sharing our continued progress throughout the year." In January 2024 did a 12 to 1 reverse stock split.

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 for recurrent respiratory papillomatosis (RRP) BLA submission is on track for 2H 2024. Will use the Accerated Approval pathway, based on Phase 2 data. The 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. Will also submit a redosing trial design to the FDA in Q3 2024.

INO-3112, which target HPV-related cancers, has received FDA feedback on the proposed trial design for HPV positive throat cancer. Plans discussion with EU regulators. Will becombined with Loqtorzi, a PD-1 inhibitor. The target is oropharyngeal squamous cell carcinoma (OPSCC).

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 candidate INO-5401 glioblastoma (GBM). 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 the Phase 2/3 trial. 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.

First dMAb trial for Covid-19 is being prepared.

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 $106 million, down sequentially from $144 million. In April 2024 generated $33 million from selling common stock and warrents. On March 1 retired $17 million in convertible notes. No debt at end of Q1.

R&D expense was $21 million. General and administrative expense was $11 million. Goodwill impairment $0 million. Total operating expenses were $31 million. Operating profit negative $31 million. Interest and other income $1 million.

Q&A selective summary:

HPV vaccines effects on disease prevalence? Launched in 2006 and 2009. They are lowering pediatric levels where vaccination rates are high, like Australia. But vaccination levels are in the low 60% for girls and lower for boys in the United States. Many adults have never been vaccinated. RRP disproportionately affects boys and men. RRP will be with us for decades to come.

Op ex increase with Phase 3? 3112 discussions with EU before trial is finalized. Believes burn should be fairly consistent with the $30 million number. Some potential increase from Phase 3 trial, once it is launched.

3107 device? We are aligning with all the latest regulations, we have lots of experience with the device from prior trials.

We think enrollment should be good as it will allow patients to access a commercial therapy. We just need to start the 3112 study before we submit the BLA.

3107 competition, device impact? Feedback is the device is tolerable to patients and easy for providers to use. We do not see it as a barrier compared to sub-q administration. Laryngologists are used to devices for administration.

Differences in Phase 2 and Phase 3 3107 populations? Minimal, but now may recruit patients with just 2 prior surgeries. We expect the overall population will be similar to the earlier trial. Median is 4 surgeries per year in this population.

We are very hopeful we will get priority review. That would mean a six-month review period. The full data from the confirmatory trial will be needed for full approval.