INOVIO Reports First Quarter Financials, Prepares for Major Drug Submissions

INOVIO Pharmaceuticals

PLYMOUTH MEETING, PA — INOVIO Pharmaceuticals (NASDAQ: INO) has released its financial results for the first quarter of 2024, revealing significant developments in its drug pipeline and a strengthened balance sheet. The company is on track to submit a Biologics License Application (BLA) for INO-3107, which could become the first non-surgical treatment for recurrent respiratory papillomatosis (RRP).

This submission, scheduled for the second half of 2024, is part of an accelerated approval pathway. If approved, INO-3107 will be the first DNA medicine available in the United States, marking a significant milestone for INOVIO’s technology platform. Dr. Jacqueline Shea, INOVIO’s President and CEO, emphasized the importance of this potential breakthrough. “We are energized by the opportunity to potentially deliver the first FDA-approved therapy for this devastating disease,” she said.

Simultaneously, INOVIO is preparing a confirmatory trial for INO-3107 based on feedback from the Food and Drug Administration (FDA). This trial aims to validate the efficacy and safety of the treatment further, ensuring comprehensive data for final approval.

In another promising development, INOVIO is advancing plans for a Phase 3 trial of INO-3112 in combination with LOQTORZI™ (toripalimab-tpzi). This combination targets oropharyngeal squamous cell carcinoma (OPSCC), a type of head and neck cancer. The trial aims to address a substantial unmet need in patients with high-risk, HPV-16/18 positive OPSCC.

Dr. Shea highlighted the potential impact of this combination therapy. “We believe the combination could address a substantial unmet need in patients with locoregionally advanced, high-risk, HPV-16/18 positive OPSCC,” she said. The company plans to discuss the Phase 3 trial design with European regulators soon.

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Financially, INOVIO has bolstered its position through an underwritten offering of common stock and pre-funded warrants completed in April 2024. This move has extended the company’s cash runway into the third quarter of 2025, providing a robust financial foundation for ongoing and future projects.

The company projects an operational net cash burn of approximately $30 million for the second quarter of 2024. However, these projections do not account for any additional capital-raising activities that may occur.

The implications of these developments are significant. Approval of INO-3107 could revolutionize the treatment of RRP, offering a non-surgical option for patients. Moreover, the success of the INO-3112 and LOQTORZI combination could provide a new therapeutic avenue for OPSCC, potentially improving outcomes for patients with this aggressive form of cancer.

By progressing these key initiatives, INOVIO aims to solidify its position as a leader in the biotechnology sector, leveraging its DNA medicine platform to address serious medical conditions. The company’s strategic focus on regulatory alignment and financial stability positions it well for sustained growth and innovation in the coming years.

As INOVIO continues to navigate the complexities of drug development and regulatory approval, its advancements offer hope for patients and promise for investors, signaling a transformative period for the company.

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