Inovio Pharmaceuticals(INO) - 2024 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Inovio's net loss for Q4 2024 was $19.4 million or $0.65 per share, with a total net loss for the full year of 2024 amounting to $107.3 million or $3.95 per share [55] - Total operating expenses decreased from $27.5 million in Q4 2023 to $20.5 million in Q4 2024, and full-year operational expenses dropped 22% from $144.8 million in 2023 to $112.6 million in 2024 [54][55] - The company finished Q4 2024 with $94.1 million in cash, cash equivalents, and short-term investments, down from $145.3 million as of December 31, 2023, estimating a cash runway into Q1 2026 [55] Business Line Data and Key Metrics Changes - The primary focus is on advancing INO-3107, with plans to submit a Biologics License Application (BLA) under the FDA's rolling submission process in mid-2025 [9][31] - INO-3107 showed a complete response rate of 50% in the second year, with the mean number of surgeries per year reducing from 4.1 to 0.9 surgeries [23][24] - The ongoing efficacy of INO-3107 is supported by immunology data demonstrating an anti-viral immune response that correlates with reduced surgery needs [12][30] Market Data and Key Metrics Changes - Recurrent respiratory papillomatosis (RRP) affects around 14,000 people in the U.S., with repeated surgeries being the standard of care [34] - The market for RRP treatment is characterized by a need for non-surgical options, as surgeries pose risks and costs to patients [35] - The company anticipates that INO-3107 could become the preferred treatment option based on its efficacy and tolerability [36] Company Strategy and Development Direction - The company aims to transform into a commercial-stage entity by focusing on three strategic priorities: submitting the BLA for INO-3107, advancing the commercial plan, and leveraging its DNA medicines platform [9][10] - The company is also exploring next-generation DNA medicines, including DMAbs technology for long-term in-vivo production of therapeutic antibodies [13][42] - Plans for a Phase 3 trial for INO-3112 in combination with a PD-1 inhibitor for HPV-related throat cancer are underway [51] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of INO-3107 as a non-surgical treatment for RRP, emphasizing the importance of reducing the need for surgeries [11][26] - The company is optimistic about the durability of the immune response generated by INO-3107 and the potential for redosing strategies to enhance treatment outcomes [136] - Management highlighted the ongoing challenges in the adult RRP population, indicating that the disease is likely to persist for generations despite vaccination efforts [140] Other Important Information - The company raised over $72 million in gross proceeds from equity offerings in 2024 to support its operations [54] - The DMAb technology has shown promising results in producing antibodies durably and simultaneously in humans, with no serious adverse events reported [44][46] - The company is preparing for commercial launch by developing distribution strategies and pricing models for INO-3107 [39][40] Q&A Session Summary Question: BLA submission process for INO-3107 - Management confirmed that a pre-BLA meeting with the FDA was held, and no further meeting is required before the rolling submission [62][64] Question: Stability testing for the CELLECTRA device - The company needs to repeat several tests for device verification, which will be conducted by an external testing house [67][68] Question: Durability of DMAb technology - The company reported that DMAb production has shown durability for up to 72 weeks without significant drop in antibody levels [113] Question: Health economics research on INO-3107 - The company has conducted research with payers, indicating a potential pricing range for INO-3107 similar to other rare disease therapies [105][106] Question: Redosing strategy for INO-3107 - Management is still deciding on the redosing strategy, aiming to maintain and potentially enhance the immune response [134][136] Question: Epidemiology and addressable market for RRP - The company noted that RRP cases in adults remain steady despite vaccination efforts, indicating a significant addressable market [140]