Inovio Pharmaceuticals, Inc.

Good day, and welcome to the Inovio Second Quarter 2023 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 touchtone phone. 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 2023 Second Quarter Conference Call. Joining me on today's call are Dr. Jackie Shea, President and CEO, Dr. Michael Sumner, Chief Medical Officer, and Mr. Peter Keyes, Chief Financial Officer. Today's call will review our corporate and financial information for the quarter ended June 30th, 2023, as well as provide a development progress update for 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.

Good afternoon, and thank you to everyone for joining today's call. In the second quarter of 2023, We continue to make important progress with INO3107, our candidate for the treatment of recurrent respiratory papillomatosis, or RRP. Following positive results from our Phase 1 and 2 trial earlier this year, our team is working to initiate a pivotal Phase 3 trial in adults as quickly as possible. We are targeting the first patient, first dose, in the first quarter of 2024. which would move us one step closer to delivering on the promise of DNA medicines for patients suffering from this debilitating disease. We are excited about this next chapter for Inovio and focused on making sure our company is scaled to support advancing our pipeline. With that in mind, and in light of what we see as a particularly challenging funding environment for pre-commercial biotech companies like Inovio, we've made some key shifts in resource allocation for our pipeline. as well as the difficult decision to further reduce our headcount and operational spending to better align with our strategic priorities. As our CMO, Michael Sumner, and CFO, Peter Keyes, will describe in more detail shortly, we announced today our decision to stop further investment in VGX3100 for cervical age still in the U.S. market. We will continue to support our partner, ApolloBio, as they advance their phase three trial for cervical HCL in China in a non-biomarker selected population, and appreciate their ongoing efforts to advance promising DNA medicines for patients in that market. To provide a clearer picture of how these decisions fit with our larger pipeline strategy, I'd like to share an overview of our current product candidates. As you can see here, we have a diverse portfolio across therapeutic areas and phases of development. In the top right corner, we have INO3107, and advancing that candidate into Phase 3 is our first priority. As I mentioned previously, we are targeting to begin dosing patients in the first quarter of 2024. In addition, we intend to advance BGX3100 in anal H-cells, as well as INO3112 and INO5401, our oncology product candidates targeting HPV-related head and neck cancer and glioblastoma. We're also excited about the potential for our earlier stage candidates targeting infectious diseases, particularly INO4201, our Ebola booster vaccine candidate. We're also encouraged to see the next generation of infectious disease vaccine candidates based on DNA-launched nanoparticles into the clinic. On this slide, you can see the clinical trials currently being conducted with Inovio's DNA medicines. Not only does it highlight the extent of the work that is underway on a number of the key candidates I just mentioned, but it also highlights the importance of our partnerships and collaborations and the breadth of interest among external parties in our technology. Also on this slide, you can see we've included our plan phase three trial for INO3107 in preparation for that trial to commence. We are focused on driving clinical progress across our pipeline, particularly for those candidates that we believe are closest to market and have the greatest chance of delivering on the promise of DNA medicine for patients. From a business standpoint, we're focused on ensuring that we have the resources to reach important catalysts. With that in mind, we've taken further steps to right-size our business to match our current pipeline needs, reducing our workforce by approximately 30%, and adjusting our physical footprint by initiating relocation of one of our two R&D facilities in San Diego, California. We estimate these cost savings will enable the company to fund operations into the third quarter of 2025. With our current capital resources, we believe we can execute on our plans for IN03107 and, as I mentioned earlier, are targeting the start of the phase three trial in the first quarter of next year. We're also taking steps to advance other promising candidates, but the next stage of clinical development will most likely require additional funding or partnerships and we're actively pursuing those opportunities. The decision to reduce the size of our organization was not taken lightly, and I would like to take this moment to extend my deepest gratitude to all of our talented and committed employees, past and present, for their efforts on behalf of the company and contributions to the important progress we're making on our DNA medicines technology. that has the potential to treat and protect patients worldwide. With that, I'd like to turn it over to our Chief Medical Officer, Dr. Mike Sumner, to provide some important clinical highlights and details on our strategic pipeline updates. Mike?