Inovio Pharmaceuticals, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Inovio fourth quarter and year end 2023 financial results conference calls. At this time, all lines are in 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 Wednesday, March 6th, 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 2023 Fourth Quarter and Full Year Financial Results Conference Call. Joining me on today's call are Dr. Jackie Shea, President and Chief Executive Officer, Dr. Michael Sumner, Chief Medical Officer, Mark Twyman, Chief Commercial Officer, and Peter Keyes, Chief Financial Officer. Today's call will review our corporate and financial information for the quarter and full year ended December 31st, 2023, as well as provide a general business update. Following prepared remarks, we will conduct a question and answer segment. During the call, we will 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, 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. The past 12 months have been transformational for Inovio. Today, we are a company planning to submit our first BLA in the second half of this year and preparing for the potential commercial launch of our first product in 2025. If approved, INO3107 could also become the first non-surgical therapeutic option for patients with RRP. and be the first DNA medicine available in the United States. To achieve this transformation, we have prioritized our product pipeline to focus on 3107 and other promising late-stage assets, all with high unmet medical need and strong commercial potential. We've remained committed to financial discipline, cutting our operating expenses nearly in half compared with 2022, and focused on leveraging the advantages of our platform to deliver on the promise of DNA medicine. In addition to the significant progress made with 3107, our strategic refocus helped drive progress across the pipeline, including a new clinical collaboration and supply agreement with Coheris Biosciences to develop INO3112 in combination with Loctorsi for throat cancer. We also shared encouraging results for INO4201 as an Ebola booster vaccine, continued to advance other clinical stage candidates, and made progress with promising preclinical research opportunities for next generation candidates, adding to the positive momentum. Looking ahead, several key catalysts will help continue that momentum across our pipeline. In addition to submitting our BLA for 3107 under FDA's accelerated approval program, we plan to initiate a confirmatory trial in the second half of 2024 and will continue preparations for a potential 2025 launch. For our immuno-oncology candidates, we plan to finalize the trial design for evaluation of 3112 in combination with Loctorsi in patients with throat cancer. as well as determine next steps for 5401 in glioblastoma, a deadly form of brain cancer. We also expect some key milestones for our infectious disease candidates, including discussions with collaborators and potential partners around development plans for INO4201 as an Ebola booster vaccine in the first half of 2024, and a readout of the first clinical data from the Phase 1 trial evaluating the anti-SARS-CoV-2 DMAB candidates in the second half of 2024. I'd now like to pass the call over to our CMO, Mike Sumner, who will provide some additional details on our clinical progress over the past year and our goals for the year ahead.