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11/8/2022
Good day and welcome to the Endovio third quarter 2022 results conference call. All participants will be in a 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. And to withdraw your question, please press star then two. Please note that this event is being recorded. I would now like to turn the conference over to Mr. Thomas Hong. Please go ahead, sir.
Thank you. Good afternoon and thank you for joining the Inovio third quarter 2022 financial results conference call. Joining me on today's call are Dr. Jackie Shea, President and CEO, Mr. Peter Keys, Chief Financial Officer, and Dr. Michael Sumner, Chief Medical 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 ended September 30th, 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 third quarter, Inovio continued to implement our strategy of delivering the promise of DNA medicines by prioritizing our resources to those candidates that have the greatest near-term potential for patient benefit and commercialization. These include INO3107, our promising DNA medicine candidate for the treatment of HPV6, and or 11 caused recurrent respiratory papillomatosis or RRP. RRP is a debilitating, often lifelong condition characterized by the development of small wart-like growths or papillomas which while generally benign can cause severe life-threatening airway obstruction and respiratory complications. The papillomas have a tendency to grow back after they have been removed surgically which is the current standard of care. There are currently no FDA-approved therapeutic vaccines or drugs for the treatment of RRP. We are encouraged by the positive interim phase 1-2 results we announced last month, not only because they build upon our ongoing work, indicating that DNA medicines have the potential to treat HPV-associated diseases, but more importantly, because these data could be the first steps toward a new therapy to improve the lives of those patients suffering from this horrible disease. While Mike will talk about the INO3107 data in greater detail in just a moment, I'd like to highlight that Inovio has long been committed to developing innovative treatments for HPV-associated diseases. Our DNA medicines have a number of characteristics that make them uniquely suited to this therapeutic area. In previously completed trials, DNA medicines have been observed to induce antigen-specific, long-lived memory, helper, and killer T-cells, which we believe may play a role in clearing the HPV virus. DNA medicines also have exhibited the potential to be readministered without the loss of immunogenicity and have favorable safety and tolerability profiles, both of which we believe are important factors in the treatment of chronic HPV cases. associated conditions like RRP. We look forward to continuing to build upon the foundation of clinical data we have generated to date in our HPV franchise to bring potentially paradigm-shifting treatment options to patients in need. In addition, we expect to announce our Reveal 2 Phase 3 data with BGX3100 in cervical high-grade squamous intraepithelial lesions or HSIL, later this quarter or in the first quarter of 2023, which will help define the next steps for this HPV-related development program. Moving beyond our HPV franchise, we remain encouraged by other candidates in our pipeline, such as INO5401, which, as we reported earlier this year at ASCO, demonstrated positive results as a potential treatment for glioblastoma. and almost always fatal cancer of the brain. We've continued working on the next steps for this product candidate and look forward to sharing our plans with you next year once we finalize some key decisions. We also look forward to continuing to advance our other pipeline programs for which we anticipate data announcements in the coming months. Since I took over the reins of Inovio almost six months ago, we have been working on continuing to drive operational excellence throughout everything we do, from running clinical trials to managing our capital and other resources to optimize our chances of successfully bringing our product candidates to the market and helping patients. Our decision to discontinue our internally funded development of INO4800 as a heterologous COVID-19 booster vaccine due to changed market conditions is reflective of this strategy. We plan to deploy cost savings from this effort to the advancement of other promising candidates. We currently believe these cost savings will now extend our cash runway into the first quarter of 2025, and we will continue to evaluate how we best deploy those resources across our portfolio as we move ahead. With that, I'd like to turn it over to our Chief Medical Officer, Dr. Michael Sumner, to provide our clinical update for the quarter. Mike?
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