Inovio Pharmaceuticals (NASDAQ:INO) is preparing to launch its first approved product, VOCERYQ, after the Food and Drug Administration granted accelerated approval for the treatment of adults with recurrent respiratory papillomatosis, or RRP, the company said on its third-quarter earnings call.
Chief Executive Officer Jackie Shea said the company’s priority is to establish VOCERYQ as a preferred first-line treatment for adults with the disease, which often requires repeated surgeries. Inovio expects the product to be available to order and ship approximately 60 days after approval, with sales expected to begin in 2027.
“Our primary focus will be maximizing the opportunity we see for VOCERYQ and executing our commercial launch,” Shea said. The company also plans to explore pediatric use, continued treatment options for adults and international markets.
Approval and clinical evidence
VOCERYQ, formerly known as INO-3107, was approved to reduce the frequency of surgery in adults with RRP. Chief Medical Officer Mike Sumner described it as the first FDA-approved plasmid DNA-based immunotherapy. The product is administered using Inovio’s CELLECTRA delivery device.
In the RRP001 study, 32 adults who had undergone two to eight surgeries in the prior year had visible papillomas surgically removed before their first dose, then received four doses over nine weeks, Sumner said. A separate retrospective study assessed treatment effects for up to three years after initial dosing.
For accelerated approval, the FDA focused its efficacy evaluation on 26 patients who had required at least three surgeries in the prior 12 months. Their median number of surgeries before the first dose was 4.5, including the surgery immediately before treatment. In the 12 months following the end of the dosing window at week nine, 27% required no surgeries to manage their disease, Sumner said.
Sumner said study participants experienced mostly low-grade treatment-emergent adverse events, including injection-site pain and fatigue. Continued approval may depend on verification of clinical benefit in a confirmatory study.
Inovio expects to submit a draft confirmatory-study protocol before year-end and aims to agree on a final protocol with the FDA by mid-2027. The company and agency have agreed that the study should enroll at least 50 adult and pediatric patients who required at least three surgical interventions in the prior 12 months, Sumner said. Subject to regulatory feedback, the study is expected to track interventions for at least three years after treatment and compare results with an external control group or a scientifically justified threshold.
Launch and coverage plans
Chief Commercial Officer Steve Egge said Inovio estimates that at least 25,000 adults in the United States have RRP, based on its analysis of claims data. The company estimates that roughly 400 laryngologists treat the vast majority of patients and plans a 20-territory field organization using deployment partner Syneos Health.
Egge said the team is designed to reach about 90% of the company’s estimated RRP patient potential. Inovio plans to engage approximately 100 large academic and integrated delivery system accounts after the full field team is deployed, as well as community hospitals and physician practices.
Based on payer research, the company expects insurers covering approximately 80% of U.S. patients to have coverage policies in place within nine months of approval. It also plans to apply for a permanent reimbursement J-code and offer support with product ordering, benefit verification, copay assistance and patient assistance.
Sumner said device training takes approximately 30 minutes and will begin more broadly when the product becomes available. Inovio expects its existing inventory and manufacturing capacity to support the first year of the launch through at least 2027, Egge said.
Loss widens as company funds commercialization
Inovio reported a third-quarter net loss of $49.2 million, or $0.50 per share, compared with a loss of $45.5 million, or $0.87 per share, a year earlier. Operating expenses fell to $19.8 million from $21.2 million.
Chief Financial Officer Peter Kies said the wider loss was primarily driven by a $26.9 million noncash loss from fair-value adjustments to warrant liabilities, compared with $22.5 million a year earlier. He said those adjustments can cause significant variability in reported losses.
The company ended the quarter with $48.4 million in cash, cash equivalents and short-term investments. A recent equity offering provided approximately $80.5 million in net proceeds, while warrant exercises after Sept. 30 generated a further $10.9 million, Kies said.
Inovio expects those resources to support operations into late fourth quarter 2027, excluding anticipated VOCERYQ sales and any further fundraising. Its projection includes approximately $21 million in operational net cash burn for the fourth quarter of 2026.
Shea said Inovio plans to submit an application for conditional marketing authorization in Europe before the end of 2026 and is actively seeking partners outside the United States. The company also intends to pursue partnerships to advance other clinical and earlier-stage pipeline candidates.
About Inovio Pharmaceuticals (NASDAQ:INO)
Inovio Pharmaceuticals, Inc. is a biotechnology company focused on developing DNA medicines, including DNA-based vaccines and immunotherapies designed to treat or prevent infectious diseases, cancers and other serious conditions. The company’s platform is intended to stimulate targeted immune responses by delivering DNA medicines into cells. Inovio’s product pipeline has included investigational therapies such as INO-3107, a DNA immunotherapy being developed for recurrent respiratory papillomatosis, and other candidates targeting cancer and infectious diseases.
