Inovio Pharmaceuticals, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Inovio Third Quarter 2024 Financial Results Conference Call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Thursday, November 14, 2024. I would now like to turn the conference over to Thomas Hong, Manager of Investor Relations. Please go ahead.

Good afternoon, and thank you for joining the Inovio Third Quarter 2024 Financial Results Conference Call. Joining me on today's call are Dr. Jackie Shea, President and Chief Executive Officer, Dr. Mike Sumner, Chief Medical Officer, Peter Keys, Chief Financial Officer, Steve Egge, Chief Commercial Officer, and Dr. Matthew Morrow, VP of Translational Sciences. Today's call will review our corporate and financial information for the quarter ended September 30th, 2024, as well as provide a general business update. Following prepared remarks, we will conduct a question and answer segment. During the call, we'll be making forward-looking statements regarding future events and the future performance of the company. These events relate to our business plans to develop Inovio's DNA medicines platform, which include clinical and regulatory developments, and timing of clinical data readouts and planned regulatory submissions, along with capital resources and strategic matters. All of these statements are based on the beliefs and expectations of management as of today. Actual events or results could differ materially. We refer you to the documents we file from time to time with the SEC, which under the heading Risk Factors, identify important factors that could cause actual results to differ materially from those expressed by the company verbally as well as statements made within this afternoon's press release. This call is being webcast live, and a link can be found on our website, ir.inovio.com, and a replay will be made available shortly after this call is concluded. I will now turn the call over to Inovio's President and CEO, Dr. Jackie Shea.

Good afternoon, and thank you to everyone for joining today's call. This quarter, We continue to make progress on the key objectives we've been focused on for 2024 to deliver value to stakeholders in the near, mid, and longer term, and most importantly, deliver on the promise of DNA medicine for patients. Those objectives include, firstly, advancing our lead product candidate, INO3107, towards commercialization. Secondly, advancing our pipeline, And thirdly, continuing to strengthen our business overall. Today, I will provide an overview of our progress and then ask my colleagues to provide greater detail. To begin with, we've recently announced important additional immunology data supporting the proposed mechanism of action for 3107 and its potential to eliminate or reduce the number of surgeries RRP patients have to face. This extensive immunological characterization data, highlighting the ability of 3107 to induce T-cell responses that correspond to the clinical benefit observed in our Phase I-II trial, has been presented at two scientific conferences, including the International Papillomavirus Conference this week. We have also presented the full safety and efficacy data, demonstrating that 3107 was shown to be well-tolerated and have clinical benefit, in our Phase 1-2 trial at two recent scientific conferences. We believe the powerful combination of this additional data further highlight the potential for 3107 to become the preferred choice for the broadest number of RRP patients, should it be approved. Mike and Steve will provide further details on this later in today's call. Moving on to regulatory matters, In August, we held a positive pre-BLA meeting with the FDA. Since then, we have continued preparing for submission of our BLA, targeted in mid-2025. We expect to have all non-device-related modules for the BLA completed by the end of this year. You'll recall during our last quarterly call, we announced we had recently identified a manufacturing issue for the single-use component of our devices. during the testing required for our BLA submission. We believe we have identified the appropriate resolution for this issue and are making good progress in implementation. In summary, we remain confident in our ability to deliver 3107 to the market for patients as an important and new therapeutic option to treat this devastating disease. As this is our primary focus, we are directing the majority of our resources, both people and financial, towards completion of development, BLA submission, and preparing for our potential commercialization of 3107. However, even with 3107 as our primary focus, we are mindful of the significant potential of the rest of our pipeline and have continued to make important progress on several other candidates as well. For INO3112, we've consulted with European regulators regarding the design of our proposed BASE-3 trial, evaluating 3112 in combination with the PD-1 inhibitor Loctorsi as a potential treatment for locally advanced HPV 16 and 18 positive high-risk oropharyngeal squamous cell carcinoma, also known as throat cancer. We anticipate conducting this trial in North America and Europe. Previous discussions with the FDA have indicated alignment with the proposed trial design. Continuing in oncology for INO5401, patients continue to be dosed in the GBM001 trial in newly diagnosed pleoblastoma that combines 5401 with Regeneron's PD-1 checkpoint inhibitor, Libteo. Regeneron and Inovio have discussed that an appropriate next step for GBM could be a controlled Phase II trial. A separate trial evaluating 5401 in patients with the BRCA mutation is ongoing at the Bassa Center at the University of Pennsylvania. We also have an upcoming meeting scheduled with the FDA later this quarter to discuss the Phase II trial design and development pathway for ino4201 as a heterologous boost to the FDA-licensed Ebola vaccine, Avibo. From our earlier stage candidates, we expect clinical data from an ongoing phase one study with DNA-encoded monoclonal antibodies to be submitted to a peer-reviewed publication by year-end. We believe this will be the first clinical data for DNA-delivered monoclonal antibodies to be reported and illustrates what we believe to be the transformational potential of our DNA medicines platform. Finally, Our commitment to financial discipline and strengthening our business is a core component of our strategy for success. While we've made substantial progress on our overall goals, we've done so while continuing to reduce our operating expenses. We closed the third quarter with $84.4 million in cash, cash equivalents and short-term investments, and with no debt. Now, I'll turn it over to Mike for some additional insights from the new data on 3107. Mike?