INOVIO Q2 2024 Financial Results and Business Highlights

PLYMOUTH MEETING, Pa., Aug. 8, 2024 -- INOVIO (NASDAQ:INO), a biotechnology company specializing in DNA medicines for HPV-related diseases, cancer, and infectious diseases, has announced its financial results for the second quarter of 2024 and provided updates on recent developments.

Dr. Jacqueline Shea, President and CEO of INOVIO, highlighted the progress of their lead candidate, INO-3107, aimed at treating Recurrent Respiratory Papillomatosis (RRP). Despite a recent manufacturing issue with the single-use disposable administration component of their device, INOVIO expects to submit their Biologics License Application (BLA) by mid-2025. The company is taking steps to address this issue, while continuing to advance regulatory progress in Europe and the U.K., and preparing for a potential launch upon approval.

INO-3107 has achieved several milestones, including receiving the Innovation Passport under the U.K.'s Innovative Licensing and Access Pathway (ILAP) and an Advanced Therapy Medicinal Product (ATMP) Certification from the European Medicines Agency. These recognitions offer accelerated access to regulatory support and development tools to potentially speed up approval timelines. Moreover, immunology data for INO-3107 will be presented at key conferences in the fourth quarter, including Fall Voice, the International Papillomavirus Conference, and the International Society for Vaccines Annual Congress.

INOVIO is also progressing with other significant projects. The company has submitted Phase 3 clinical plans for INO-3112, targeting oropharyngeal squamous cell carcinoma (OPSCC), to European regulatory authorities. This multi-center trial will evaluate the combination of INO-3112 and LOQTORZI, an FDA-approved PD-1 inhibitor, to address high-risk HPV-related throat cancer. However, the same manufacturing issue impacting INO-3107 needs resolution before the INO-3112 trial can commence.

Additionally, INOVIO plans to resubmit Phase 2 clinical plans for its Ebola booster vaccine, INO-4201, to the FDA in the third quarter. Previous Phase 1b trials showed that INO-4201 was well-tolerated and boosted immune responses in all participants.

Operational updates include the appointment of Steve Egge as Chief Commercial Officer. With extensive experience in HPV-related diseases, cancer, and immunology, he is expected to significantly contribute to the commercial strategies for INO-3107 and other pipeline candidates. Egge's background includes leadership roles at Merck, where he was involved in over 13 product launches.

Financially, INOVIO reinforced its position with a common stock and pre-funded warrant offering in April 2024, raising $33.2 million. As of June 30, 2024, the company held $110.4 million in cash, cash equivalents, and short-term investments, compared to $145.3 million as of December 31, 2023. The company's research and development expenses slightly decreased to $23.1 million, while general and administrative expenses fell to $10.2 million. Overall, total operating expenses were $33.3 million, down from $37.3 million in the same period in 2023. The net loss for the quarter was $32.2 million, or $1.19 per share, improving from a net loss of $35.5 million in the same quarter of the previous year. As of June 30, 2024, INOVIO had 26.0 million common shares outstanding.

INOVIO estimates its cash runway to last into the third quarter of 2025, factoring in an anticipated net cash burn of approximately $28 million for the third quarter of 2024. These projections do not account for potential additional capital-raising activities.

INOVIO's DNA medicines platform comprises precisely designed DNA plasmids delivered by the proprietary CELLECTRA® device, which enables targeted protein production to combat diseases. The company continues to innovate in the realm of DNA medicines, aiming to enhance treatment options for diseases caused by HPV, cancer, and other infections.

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