Aug 12, 2026 earnings call — INO BLA review and launch preparations
FDA review advancing for BLA of INO-3.11 thousand; on track for the October 30 PDUFA date.
EPS $-0.07 (est $-0.22)
Key quotes
"We are on track for the October 30 target PDUFA date"
"To execute on this opportunity, we plan to leverage experienced field teams and we are pleased to share that Syneos Health, has deep experience in rare disease launches, will serve as Inovio's contract sales organization to support commercialization in the U.S."
"Net proceeds from the offering after deducting underwriter discounts, commissions, and operating expenses were $18.3 million."
Analyst Q&A 2
FDA meeting and follow-up trial plan
Q (Lian Chan · Jefferies): The analyst asked for details on the informal FDA meeting about INO-3.11 thousand and whether FDA raised new efficacy, safety, or CMC questions. He also asked for updates on the confirmatory trial design, patient population, endpoints, and timing to start after approval.
A: Management said the FDA had seen the full dataset and did not disagree with their efficacy and safety positioning, but the FDA would not comment on eligibility because the file is under active review. They are waiting for FDA comments on the protocol submitted to the IND and expect those comments to be forthcoming. They said they will discuss expectations for starting the trial with FDA and do not believe starting that trial will affect approvability or the PDUFA date.
"So the FDA had seen the entirety of the data that we submitted to them." — Michael Sumner
Cash runway and launch costs
Q (H.C. Wainwright): The analyst asked whether the company will need another capital raise before PDUFA or will bridge launch with revenue and a financing partner. A follow-up asked whether the funding through first quarter 27 includes prelaunch inventory and launch marketing spend.
A: Management said the company is funded through late first quarter 27, which is after the anticipated launch, so they are funded through the projected launch date. They confirmed that prelaunch inventory build and launch marketing spend are built into costs across fourth quarter and first quarter.
"So as we as we discussed on the call, we are currently funded through late first quarter 27." — Jacqueline E. Shea (CEO)