Release Date: March 18, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Inovio Pharmaceuticals Inc (NASDAQ:INO) has resolved the manufacturing issue with the single-use array component of the Selectra device, which is crucial for their BLA submission for INO 3,107.
• The company plans to begin the BLA submission process in mid-2025, with the goal of FDA acceptance by the end of the year.
• Clinical data for INO 3,107 shows significant and durable clinical benefits, with a reduction in the need for surgeries for RRP patients.
• Inovio Pharmaceuticals Inc (NASDAQ:INO) has made progress in developing their DNA encoded monoclonal antibody technology, showing durable in vivo production in humans.
• The company has reduced operational expenses by 22% from 2023 to 2024, demonstrating effective cost management.

Negative Points

• Inovio Pharmaceuticals Inc (NASDAQ:INO) experienced delays in resolving the manufacturing issue, which took longer than initially expected.
• The company reported a net loss of $107.3 million for the full year of 2024, indicating ongoing financial challenges.
• Cash and cash equivalents decreased significantly from $145.3 million in 2023 to $94.1 million in 2024, raising concerns about financial sustainability.
• The company needs to initiate a confirmatory trial before the BLA submission, which could pose additional challenges and delays.
• There is uncertainty regarding the long-term epidemiology and market size for RRP, as vaccination rates and disease prevalence could impact future demand.

Q & A Highlights

• Warning! GuruFocus has detected 6 Warning Signs with INO.

Q: For the BLA submission request for INO 3,107, do you need to meet with the FDA, or is it just a written request? A: (Dr. Mike Sumner, Chief Medical Officer) We held a pre-BLA meeting with the FDA before resolving the single-use array issue. We had good alignment on the remaining modules, so we don't need another meeting. We plan to request the rolling submission in mid-2025.

Q: Regarding the stability test for the device, is it a single test or a series of tests, and who conducts them? A: (Dr. Mike Sumner, Chief Medical Officer) We need to repeat several tests for verification, which are conducted by an external testing house. This includes external certification required for our BLA.

Q: Can you provide insights into the durability of in vivo antibody production from the DMAP technology? A: (Dr. Jackie Shea, President and CEO) The DMAP technology has shown durable antibody production, with levels stable for 72 weeks. We are exploring inducible or repressible promoters for future trials to control expression.

Q: What are the commercial assumptions for INO 3,107, and how do you see it positioned against competitors? A: (Dr. Jackie Shea, President and CEO) INO 3,107 has a strong product profile with durable efficacy and a patient-centric regimen. It can be administered in a doctor's office without the need for surgery during dosing. We are confident in its competitive positioning.

Q: How should we think about the redosing strategy for INO 3,107, and what is the long-term outlook for the RRP market? A: (Dr. Mike Sumner, Chief Medical Officer) We are still deciding on the redosing strategy, aiming to reduce surgeries to zero. The RRP market remains significant, especially in adults, as vaccination rates are not yet high enough to impact adult cases significantly.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.