Release Date: November 14, 2024

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

Positive Points

• Inovio Pharmaceuticals Inc (NASDAQ:INO) reported significant progress in advancing their lead product candidate, INO-3107, towards commercialization.
• The company presented compelling immunology data supporting the mechanism of action for INO-3107, indicating its potential to reduce or eliminate surgeries for RRP patients.
• Inovio Pharmaceuticals Inc (NASDAQ:INO) held a positive pre-BLA meeting with the FDA and is on track to submit their BLA by mid-2025.
• The company has reduced operating expenses by 24% year-over-year, demonstrating financial discipline.
• Inovio Pharmaceuticals Inc (NASDAQ:INO) closed the third quarter with $84.4 million in cash, cash equivalents, and short-term investments, with no debt.

Negative Points

• Inovio Pharmaceuticals Inc (NASDAQ:INO) identified a manufacturing issue with the single-use component of their device, which needs resolution before proceeding with certain trials.
• The company's cash position decreased from $145.3 million at the end of 2023 to $84.4 million by the end of Q3 2024.
• The initiation of the Phase 3 trial for INO-3112 is dependent on resolving the device manufacturing issue.
• Inovio Pharmaceuticals Inc (NASDAQ:INO) has not yet reached out to regulatory bodies in Japan and China for INO-3107, potentially delaying market entry in these regions.
• The company faces potential competition from Precigen's product, which may launch in 2025, impacting market dynamics for INO-3107.

Q & A Highlights

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

Q: Can you talk about any regulatory updates for INO-3107 outside the US, particularly in the EU, UK, Japan, and China? A: (Dr. Mike Sumner, Chief Medical Officer) We have met with the UK and received similar advice to the EU, which requires compelling placebo-controlled data for approval. We need to complete this study before submitting in Europe. We have not yet reached out to Japan and China, but they are areas of interest for us to progress.

Q: Could you share any physician feedback on the new immunology data presented at AACR and IPVC? A: (Dr. Mike Sumner, Chief Medical Officer) The data is compelling and helps clinicians and scientists understand the immunological basis of INO-3107, which increases their confidence in the clinical data. This will tie in nicely with our BLA submission.

Q: Can you provide additional detail on the steps to resolve the manufacturing issue with the single-use component of your device? A: (Dr. Jackie Shea, President and CEO) We encountered the issue earlier this summer and have identified the appropriate resolution. We are making good progress in implementing this resolution.

Q: How does INO-3107 differ from Precigen's product, and how do you see the competitive landscape? A: (Dr. Jackie Shea, President and CEO) INO-3107 is a DNA medicine, while Precigen's product uses an adenoviral vector. Our trial design counted every surgery after day zero, emphasizing that every surgery matters to patients. The treatment regimens and trial designs are fundamentally different.

Q: What is the timeline for initiating the confirmatory trial for INO-3107, and how does it fit with the BLA submission? A: (Dr. Jackie Shea, President and CEO) We are targeting our BLA submission for mid-2025. The FDA requires us to start the confirmatory trial before commencing the BLA submission. We are actively preparing to demonstrate our commitment to delivering on this confirmatory study.

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