Inovio Pharmaceuticals, Inc.

Good afternoon and welcome to the Inovio Pharmaceuticals fourth quarter 2022 financial results conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star, then two. Please note, this event is being recorded. 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 2022 Fourth Quarter and Full Year Financial Results Conference Call. Joining me on today's call are Dr. Jackie Shea, President and CEO of Dr. Michael Sumner, Chief Medical Officer, and Mr. Peter Keyes, Chief Financial Officer. We also have other members of Inovio's leadership here with us today who will be part of our Q&A session. Today's call will review our corporate and financial information for the quarter and year ended December 31st, 2022, as well as provide an update on our efforts to develop our DNA medicines platform. 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.

Thank you, Thomas. Good afternoon and thank you to everyone for joining today's call. In the past year, Inovio has taken measured and at times difficult steps to prioritize our pipeline to focus on our programs with the highest probability of clinical and regulatory success and strongest commercial potential. Guided by our commitment to operational excellence and financial discipline, we are positioning Inovio to best advance our key clinical programs and realize the potential of DNA medicines for patients. In our press release today, we announced the top-line results from our Reveal 2 trial of VGX3100. Later in the call, our Chief Medical Officer, Dr. Mike Sumner, will provide a detailed summary of our clinical programs But I'd like to take this opportunity to highlight some key points about the REVEAL-2 trial, as well as our work on INO3107 as a potential treatment for recurrent respiratory papillomatosis, or RRP, both of which are HPV-related diseases. As you may recall, in April last year, we changed the primary endpoint of REVEAL-2 from an all participants population to an investigational biomarker selected population. We made this decision based on our analysis of data from Reveal 1, from which we had defined an investigational biomarker signature that may have the potential to identify those women more likely to respond to treatment with VGX3100. In Reveal 2, VGX3100 did not achieve statistical significance in the primary biomarker-selective population for the endpoint of lesion regression and viral clearance. However, VGX3100 did achieve statistical significance in the all-participants population, the original primary population for the trial, for the endpoint of lesion regression and viral clearance. Furthermore, the reveal to all-participants data and the combined data across Reveal 1 and Reveal 2 trials build upon the considerable data package that we have now obtained over multiple clinical trials that indicate DNA medicines are potentially able to clear the HPV virus and regress HPV-related lesions. It also strengthens our confidence in our other HPV-related programs, including INO3107 for RRP, where we recently reported encouraging data from the first and second cohorts from a Phase 1-2 trial. RRP is a truly devastating disease that can be overwhelming in patients' lives. And we believe INO3107 has the potential to help alleviate this burden and improve the quality of life for those suffering from this terrible disease. We are focused on advancing INO3107 to the next stage of development, and I look forward to sharing updates on our progress with you in the coming months. Moving on to our infectious disease portfolio, last month we announced positive results from a Phase 1B clinical trial evaluating INO4201 as a booster vaccine candidate in healthy adult participants who have previously received a single injection of Avibo an FDA-approved vaccine for Ebola. We believe this data supports our position that DNA medicines could be an important part of global medical countermeasures against infectious diseases, either as primary vaccines or as boosters to existing vaccines. Infectious diseases like Ebola remain an ever-present threat globally. We are currently in discussions with our collaborators and also potential partners regarding the next development steps for INO4201. In addition to the progress on the clinical front, we have been working to strengthen our financial position. Peter will provide the details, but our emphasis on pipeline prioritization, operational excellence, and financial discipline has allowed us to reduce our cash burn substantially since last year. Given these efforts, our cash runway is expected to take us into the first quarter of 2025. Financial prudence will continue to be an area of high importance at Inovio and underpin our decision-making process going forward. With that, I'd like to turn the call over to Mike to provide a more detailed update on our clinical pipeline and recent highlights.