INOVIO Announces Q1 2024 Financial Results and Business Highlights

INOVIO, a biotechnology company focusing on DNA medicines for the treatment of HPV-related diseases, cancer, and infectious diseases, has announced its financial results for the first quarter of 2024 and provided updates on several key developments. Among the significant milestones, INOVIO is on track to submit a Biologics License Application (BLA) for INO-3107 in the latter half of 2024. If approved, this could mark the first non-surgical treatment for recurrent respiratory papillomatosis (RRP). The company is also preparing for a confirmatory trial for INO-3107, incorporating feedback from the FDA regarding the trial's design.

Dr. Jacqueline Shea, President and CEO of INOVIO, expressed enthusiasm about the potential impact of INO-3107 on RRP patients and noted the company's progress towards the Phase 3 trial of INO-3112 combined with LOQTORZI for oropharyngeal squamous cell carcinoma (OPSCC). This collaboration aims to address a significant unmet need for patients with high-risk HPV-16/18 positive OPSCC.

Key Business Developments:

1. INO-3107 for RRP: INOVIO is set to submit its BLA for INO-3107 in the second half of 2024, anticipating accelerated approval. The confirmatory trial, designed with FDA guidance, will focus on reducing the need for surgical intervention in RRP patients. Current treatments involve repeated surgeries, which pose risks of vocal cord damage. The trial aims to recruit about 100 patients, randomly assigning them to receive the treatment or a placebo, with a treatment option for the placebo group post-trial.

- Trial Design Advantages: INOVIO's previous Phase 1/2 trial for INO-3107 showed promising results, with 81.3% of participants experiencing a reduction in surgical interventions post-treatment. The treatment generated antigen-specific T cells targeting HPV-6 and HPV-11, crucial for its therapeutic effect. The confirmatory trial aims to validate these findings on a larger scale, potentially paving the way for global market expansion.

2. INO-3112 for OPSCC: The FDA reviewed the proposed Phase 3 trial design for INO-3112 combined with LOQTORZI. This trial will be conducted in both Europe and North America, aiming to improve treatment for high-risk HPV-16/18 positive OPSCC patients. LOQTORZI, an FDA-approved PD-1 inhibitor, is expected to enhance the tumor-infiltrating abilities of T cells generated by INO-3112.

3. Financial Highlights:
- Balance Sheet: INOVIO strengthened its financial position through an underwritten offering of common stock and pre-funded warrants, raising approximately $33.2 million in April 2024.
- Financial Performance: As of March 31, 2024, the company had $105.6 million in cash and investments, down from $145.3 million at the end of 2023. R&D expenses were reduced to $20.9 million from $30.2 million year-on-year, mainly due to decreased costs in discontinued COVID-19 studies. General and administrative expenses also decreased, primarily due to lower compensation and legal costs.
- Reverse Stock Split: A reverse stock split was effected in January 2024, consolidating every twelve shares into one.
- Net Loss: INOVIO reported a net loss of $30.5 million for the first quarter of 2024, compared to $40.6 million for the same period in 2023.

4. Cash Guidance: INOVIO projects its cash runway to extend into the third quarter of 2025, accounting for an estimated net cash burn of approximately $30 million for the second quarter of 2024.

INOVIO continues to advance its platform for DNA medicines, leveraging its proprietary CELLECTRA® devices for optimal delivery without the need for chemical adjuvants or lipid nanoparticles. This technology aims to enable the body to produce specific proteins that target and fight diseases.

In conclusion, INOVIO is making significant strides in its clinical programs and financial stability, positioning itself to potentially bring groundbreaking DNA medicines to market, thus addressing critical unmet medical needs.

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