Overview

INOVIO Pharmaceuticals is a clinical-stage biotechnology company focused on developing and commercializing DNA medicines to treat and protect people from diseases like HPV, cancer, and infectious diseases. The company uses proprietary technology to design DNA plasmids that can instruct the body’s cells to produce specific proteins to fight disease. INOVIO’s investigational CELLECTRA devices are designed to deliver these DNA plasmids into the body’s cells.

INOVIO’s lead candidate is INO-3107 for the treatment of recurrent respiratory papillomatosis (RRP), a rare and debilitating disease caused by HPV. The company received feedback from the FDA that the data from the completed INO-3107 trial could support a Biologic License Application (BLA) submission under the FDA’s accelerated approval program. However, INOVIO identified a manufacturing issue with the CELLECTRA 5PSP device that will be used in the confirmatory trial, which has delayed the BLA submission timeline to mid-2025.

INOVIO is also developing other DNA medicine candidates, including INO-3112 for oropharyngeal squamous cell carcinoma (a type of head and neck cancer) and INO-5401 for glioblastoma multiforme (an aggressive brain cancer). The company has partnerships and collaborations with various organizations to support its research and development efforts.

Financial Performance

INOVIO’s financial results for the years ended December 31, 2024 and 2023 are summarized in the table below:

Revenue was primarily derived from collaborative arrangements and other contracts, including a significant contribution from a single collaborator, ApolloBio, which accounted for 100% and 29% of revenue in 2024 and 2023, respectively.

The $11.1 million decrease in research and development expenses was primarily due to lower employee compensation, drug manufacturing costs, and clinical study expenses, partially offset by higher expenses related to INO-3107 and device development.

General and administrative expenses decreased by $10.6 million, mainly due to lower employee compensation and legal expenses.

INOVIO recognized a $10.5 million goodwill impairment charge in 2023 due to a decline in the company’s stock price and market capitalization.

The net loss decreased by $27.9 million (21%) in 2024 compared to 2023, primarily due to the lower operating expenses.

Strengths and Weaknesses

Strengths:

• Promising lead candidate INO-3107 for the treatment of RRP, with potential for accelerated approval
• Diversified pipeline of DNA medicine candidates targeting various diseases, including cancer and infectious diseases
• Partnerships and collaborations with various organizations to support research and development
• Proprietary CELLECTRA device technology for optimal delivery of DNA medicines

Weaknesses:

• Significant accumulated deficit of $1.7 billion and continued operating losses, indicating the company’s need for additional funding
• Delay in the BLA submission for INO-3107 due to a manufacturing issue with the CELLECTRA 5PSP device
• Discontinuation of development for the VGX-3100 candidate in the United States, although the collaborator in China continues to pursue it
• Reliance on a single collaborator, ApolloBio, for a significant portion of revenue

Outlook and Future Prospects

INOVIO’s current cash resources are not sufficient to complete the clinical development of its product candidates beyond INO-3107, and the company anticipates the need for additional financing to complete the development and potential commercialization of INO-3107 and other product candidates.

The company expects its cash runway to extend through the fourth quarter of 2025, without giving effect to any further capital raising activities. However, management believes there is substantial doubt about INOVIO’s ability to continue as a going concern beyond the fourth quarter of 2025 due to its history of losses and the need for additional funding.

The successful development and regulatory approval of INO-3107 and other product candidates, as well as the company’s ability to secure additional funding, will be critical to INOVIO’s future prospects. The resolution of the manufacturing issue with the CELLECTRA 5PSP device and the initiation of the confirmatory trial for INO-3107 will be important milestones in the near-term.

Additionally, the progress of INOVIO’s other pipeline candidates, such as INO-3112 and INO-5401, and the company’s ability to establish new partnerships and collaborations will also contribute to its long-term success.

Overall, INOVIO faces significant challenges in its quest to develop and commercialize its DNA medicine candidates, but the company’s proprietary technology, diversified pipeline, and existing partnerships provide a foundation for potential future growth, provided it can secure the necessary funding and overcome the current obstacles.