Inovio Posts $49.2 Million Loss After VOCERYQ Approval
The DNA-medicine company reported a $49.2 million net loss for the three months ended September 30, 2026, as it prepared to ship the first FDA-approved DNA medicine.
Inovio Pharmaceuticals (INO), a commercial-stage biotechnology company developing DNA medicines for HPV-related diseases, cancer and infectious diseases, reported a net loss of $49.2 million, or $0.50 a share, for the three months ended September 30, 2026, compared with a net loss of $45.5 million, or $0.87 a share, a year earlier.
The company said the wider loss was primarily driven by a $26.9 million non-cash loss on the fair-value adjustment of warrant liabilities, versus a $22.5 million non-cash loss in the same period of 2025. It said the adjustment can produce significant variability in reported net loss as the fair value of the warrants fluctuates with the share price and other market inputs.
Revenue from collaborative arrangements was $298,901 in the quarter, versus zero a year earlier.
Research and development expenses fell to $10.6 million from $13.3 million. The company attributed the decrease primarily to lower engineering outside services related to device development and lower employee and consultant compensation, including stock-based compensation. Selling, general and administrative expenses rose to $9.2 million from $7.9 million, which the company said was due to the anticipated launch of VOCERYQ. Total operating expenses decreased to $19.8 million from $21.2 million.
On October 30, 2026, the U.S. Food and Drug Administration granted accelerated approval for VOCERYQ (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), previously INO-3107, to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis. The company said the product is expected to be available to order and ship in approximately 60 days from the approval date, with full commercial launch in the first quarter of 2027.
The indication was approved under the accelerated approval program based on a demonstrated complete response, defined as no requirement for surgical intervention in the 12 months after treatment in the efficacy population. VOCERYQ was approved in combination with CELLECTRA 5PSP, Inovio’s proprietary DNA medicine delivery device. The company said the approval was supported by data from its RRP-001 study in 32 adult patients and that the drug was found to be well tolerated.
President and Chief Executive Officer Jacqueline Shea said FDA described VOCERYQ as a groundbreaking therapy that fights RRP at its source, not only its symptoms, and that Inovio is now a commercial-stage company with a primary goal of establishing VOCERYQ as the preferred first-line immunotherapy for RRP patients.
A confirmatory study is expected to be conducted to verify clinical benefit. Inovio expects to submit a draft protocol to FDA by the end of 2026 and to align on a final protocol by mid-2027. It also plans to submit an application for conditional marketing authorization for VOCERYQ in Europe before the end of 2026. Current inventory and capacity are expected to support at least the first year of launch through 2027. The company has engaged Syneos Health to support recruitment and deployment of medical and commercial field teams.
Cash, cash equivalents and short-term investments were $48.4 million as of September 30, 2026, excluding net proceeds of approximately $80.5 million from a November 2026 public offering, compared with $58.5 million as of December 31, 2025.
Inovio estimates that current cash, cash equivalents and short-term investments will support operations into late fourth quarter 2027, past the launch of VOCERYQ. That projection includes the approximately $80.5 million of November offering proceeds, $10.9 million in proceeds from the exercise of warrants after September 30, 2026, and an estimated $21.0 million operational net cash burn for the fourth quarter of 2026. The company said the runway does not include revenues from VOCERYQ sales expected to commence in 2027 or any further capital-raising.
The company said it is continuing discussions with potential partners to accelerate development of its DNA-Encoded Protein programs in rare diseases, including Hemophilia A, Fabry Disease and hypophosphatasia.