Results & Analyst Call Summary

Conference date: August 12, 2025 @ 1:30 PM Pacific Time
for quarter ending: June 31, 2025 (Q2, second quarter)

Forward-looking statements

Overview: On track for INO-3107 filing in 2H 2025 (delayed from midyear)

Basic data (GAAP):

Revenue was $0 thousand, down sequentially from $65 thousand, and down from $101 thousand in the year-earlier quarter. Revenue is from research collaborations and grants.

Net income was negative $23.5 million, down sequentially from negative $19.7 million, and up from negative $32.2 million year-earlier.

EPS (earnings per share, diluted) was negative $0.64, down sequentially from negative $0.51, and up from negative $1.19 year-earlier. Share count increase substantially y/y to nearly 39 million or 52 million fully-diluted.

Guidance:

Cash runway to Q2 2026.

Quarter Highlights:

Dr. Jacqueline [Jackie] Shea, Inovio's CEO said, "With device DV testing complete, we remain on track to submit our BLA for INO-3107 in the second half of this year, with the goal of having FDA acceptance of the file by year end. Utilizing our breakthrough therapy designation, we've requested rolling submission and expect to be able to immediately provide the clinical and non-clinical modules for review, while we complete work on the device-related sections and update our Investigational New Drug (IND) Application for our confirmatory trial. We believe that INO-3107 could become the preferred treatment option for Recurrent Respiratory Papillomatosis (RRP) patients and their physicians—a treatment option with the potential to change the trajectory of this disease. I look forward to building on the significant progress of this past quarter and providing updates as we work toward a potential approval date in mid-2026."

Plans to complete the rolling submition the BLA for INO-3107 for RRP (Recurrent Respiratory Papillomatosis) in 2025, including the device component. Design verification of Cellectra 5psp device is complete. INO-3107 planning go-to-market strategy. Pricing will be in line with rare disease pricing, feedback from payers is good. Will build field teams in 2025. Also planning confirmatory Phase 3 trial. PDUFA date could be mid 2026. Is currently manufacturing the new device. In Q2 2025 rleased new data in The Laryngoscope showing 3107 if effective in reducing surgeries as long as 3 years after treatment. Mean number of surgeries was reduced from 4.1 in the 52 week pre-treatment period to 1.7 for Year 1, then to 0.9 for Year 2. Half of patients required no surgeries at all. Believes there are about 14 thousand active RRP cases in the U.S. and similar prevalence in the EU. Working towards applying for authorization in EU, which will require the Phase 3 data.

Emphasized progress in the DMAb (DNA-encoded monoclonal antibody) technology. New data was released in July 2025 at the Orphan Drug Summit. Announced interim data from the proof-of-concept DMAb Phase 1 clinical trial (for Covid 19). 100% (24/24) of participants who reached week 72 maintained biologically relevant levels of DMAbs. Believes can address multiple diseases and is searching for partners for development.

In July 2025 Inovio raised $22.5 million with a public stock and warrant offering.

Described why 3107 will be the prefered treatment for RRP, even if a competitor gets FDA approval first. More tolerable, safe and effective. Regimen can be done in physician's office and no survery or scoping required. Negotiating with payers and HCPs.

Reduced op ex 26% y/y. So reduced net loss.

Inovio is also working to advance its oncology product candidate INO-5401 glioblastoma (GBM). 5401 Phase 1/2 data is being finalized. The next step will be a placebo-controlled Phase 2 trial. 5401 is also being studied at the Basser Center in a Phase 1 trial to prevent cancer in people with BRCA mutations.

Collaborator ApolloBio continues recruitment into its Phase 3 trial evaluating INO-3100 as a potential treatment for HPV 16/18 positive cervical dysplasia in China.

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 $47.5 million, down sequentially from $68.4 million. The $22.5 million raise came in Q3. No debt.

Q4 2024 R&D expense was $15 million. General and administrative expense was $9 million. Goodwill impairment $0 million. Total operating expenses were $23 million. Operating profit negative $23 million. Interest and other income net $0.6 million. Change in fair value of stock warrant liability $2 million. Gain on investment $1 million. Net unrealized gain on securities $1 million. Other expense $1 million.

Q&A selective summary:

Advisory Committee? Based on interactions to date, an Ad Com is unlikely, but it possible.

Competitor regulatory decision? There are a lot of differences between the two therapies. They maintained scoping and survery during dosing. Candidate pool was also different. Mechanism of action is different, virus v. DNA. Even the confirmatory trials have different designs, ours is placebo controlled, theirs is single arm.

Was there a delay in device preparation? DV tasking is a complicated process involving multiple external vendors. We did it and are focussed on the submission.

We will move forward with a redosing strategy, probably once per year. RRP can be a chronic, lifelong disease.

Any issue with enrolling patients for Phase 3? Even if Precigen therapy is approved, there will be a lag in coverage, so we should be able to enroll. Only about 100 patients in trial.

Because the limited number of treating physicians, the sales team can be relatively small.

Hopes to have acceptance of the BLA by the FDA by year end.

We are expecting rare disease pricing, which payers think is appropriate. Perhaps in the $300,000 per year range.

Any Eu differences for Phase 3? In Europe they tend to do the procedure in surgeries, which limit booking and reduces the number of surgeries.

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