NASDAQ:INO Inovio Pharmaceuticals Q2 2024 Earnings Report $1.74 +0.02 (+1.16%) Closing price 04/17/2025 04:00 PM EasternExtended Trading$1.73 -0.01 (-0.52%) As of 04/17/2025 06:24 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Inovio Pharmaceuticals EPS ResultsActual EPS-$1.19Consensus EPS -$1.10Beat/MissMissed by -$0.09One Year Ago EPS-$1.56Inovio Pharmaceuticals Revenue ResultsActual Revenue$0.10 millionExpected Revenue$0.10 millionBeat/MissMet ExpectationsYoY Revenue GrowthN/AInovio Pharmaceuticals Announcement DetailsQuarterQ2 2024Date8/8/2024TimeAfter Market ClosesConference Call DateThursday, August 8, 2024Conference Call Time4:30PM ETUpcoming EarningsInovio Pharmaceuticals' Q1 2025 earnings is scheduled for Monday, May 12, 2025, with a conference call scheduled at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Inovio Pharmaceuticals Q2 2024 Earnings Call TranscriptProvided by QuartrAugust 8, 2024 ShareLink copied to clipboard.There are 11 speakers on the call. Operator00:00:00Good afternoon, ladies and gentlemen, and welcome to the Indovio Second Quarter 20 24 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. This call is being recorded on Thursday, August 8, 2024. I would now like to turn the conference over to Thomas Hong, Manager of Investor Relations. Operator00:00:32Please go ahead. Speaker 100:00:35Thank you. Operator00:00:36Good afternoon, ladies and gentlemen, and thank you for joining us for Acacia Research Second Quarter 2024 Earnings Conference Call. My name is Prilla, and I will be your conference operator today. All lines are currently on mute to prevent any background noise. I would like to remind you that this conference is being recorded today and is available through audio webcast on the company's website. Following the speakers' remarks, there will be time for questions. Operator00:01:01Analysts and investors are reminded that any additional inquiries Speaker 200:01:19Hello, operator? Operator00:01:38Good afternoon, ladies and gentlemen, and welcome to the Indovio Second 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. This call is being recorded on Thursday, August 8, 2024. I would now like to turn the conference over to Thomas Hall, Manager of Investor Relations. Operator00:02:11Please go ahead. Speaker 100:02:15Good afternoon and thank you for joining the Inovio's Q2 2024 Financial Results Conference Call. Joining me on today's call are Doctor. Jackie Hsieh, President and Chief Executive Officer Doctor. Michael Sumner, Chief Medical Officer Peter Kies, Chief Financial Officer and Steve Agee, Chief Commercial Officer. Today's call will review our corporate and financial information for the quarter ended June 30, 2024, as well as provide a general business update. Speaker 100:02:47Following 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. Speaker 100:03:22We 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. Will now turn the call over to Innovia's President and CEO, Doctor. Jackie Shea. Speaker 200:03:53Thank you, Thomas. Good afternoon, and thank you to everyone for joining today's call. To begin with today, I'd like to discuss the progress we've made thus far for 2024 based on the goals we set out at the beginning of this year. That includes advancing our lead INO-three thousand one hundred and seven development program, advancing other promising candidates in our pipeline and finally strengthening our business as a whole. Our primary focus has been working towards the potential commercialization of 3,107 for the treatment of recurrent respiratory papillomatosis or RRP. Speaker 200:04:36We have made significant progress preparing our BLA package and expect all non device related elements to be completed by year end. A positive pre BLA meeting with the FDA last week provided us with further confidence that we remain on the right track for submission. We've also made important regulatory progress in both UK and Europe and have continued to advance planning for our re dosing trial. However, as announced earlier today, we have identified a manufacturing issue with a single use disposable administration component of our device during the testing process required to support our BLA filing and that will impact the timing of our BLA submission. Every day matters to patients and we're working to resolve this issue as quickly as possible. Speaker 200:05:31Our Chief Medical Officer and RRP Program Lead, Mike Sumner will provide more details. But I want to emphasize that we're confident in our path forward and remain focused on the opportunity to deliver not only what could be the 1st FDA approved therapy for this devastating disease, but the 1st DNA medicine approved for use in the United States. What's more, Inovio has continued making progress on other key objectives for both the near and longer term to deliver value to stakeholders. Elsewhere in our pipeline, we've submitted our Phase III trial design for INO-three thousand one hundred and twelve in combination with LOPTORZY for the treatment of throat cancer to the European Medicines Agency for review. We're also planning to submit our Phase 2 trial for INO-four thousand two hundred and one as an Ebola vaccine booster to the FDA later this month and have advanced discussions with partners for the next trial for INO-five thousand four hundred and one in glioblastoma, a deadly brain cancer. Speaker 200:06:38At the same time, we've continued to strengthen our business by prioritizing financial discipline and operational excellence. As Peter will discuss shortly, we closed the Q2 with $110,000,000 in cash and short term investments with no debt on our balance sheet and raised approximately $33,000,000 through an offering of common stock and prefunded warrants this past April. We estimate that our current cash will be sufficient to fund our operations into the Q3 of 2025. We also recently welcomed Steve Eggie as our new Chief Commercial Officer and I'm delighted to have him join our leadership team. Steve has broad therapeutic area experience including in HPV related diseases in cancers, vaccines and rare disease And his career has spanned both biotech and large pharma. Speaker 200:07:34Steve recently launched a new women's health product at Myovant Sciences, which was later acquired by Sumitomo Pharma. He also spent 20 years at Merck, where he held a number of senior commercial leadership roles, including leading their HPV vaccines franchise and serving as Chief Marketing Officer for the Vaccine Division. Over the course of his career, he has overseen or contributed to more than a dozen commercial product launches. His broad commercial expertise will be invaluable as we work to advance 3,107 and our other promising candidates. I'd like to invite Steve to share more about why he joined Inovio and the potential he sees for 3,107. Speaker 200:08:16Steve? Speaker 300:08:18Thank you, Jackie, and hello, everyone. I'd like to start by saying how excited I am to be here and to be leading the very talented commercial team at Inovio, working to advance a lead candidate that I believe could transform the lives of people living with RRP and potentially bring the first DNA medicine to patients in the United States. I spent my career getting innovative medicines to market for patients with significant unmet medical needs and I believe 3,107 offers a compelling product profile that could make it the preferred choice for the broadest number of RRP patients, healthcare providers and payers. 3,107 demonstrated significant impact in our Phase onetwo trial where over 80% of patients across the disease severity continuum had a reduction in the number of surgeries compared to the previous year. It's important to note that our treatment regimen does not require surgeries during the dosing window to maintain minimal residual disease. Speaker 300:09:153,107 also targets and has shown efficacy against both HPV-six and 11, which cause RRP. 3,107 has demonstrated the ability to generate antigen specific T cells in patients that we believe leads to reduction in surgery by eliminating infected cells, thus preventing the papillomas from growing back. As DNA medicines do not generate anti vector immunity, we believe we will have the potential to redose 3,107 if needed to maintain or enhance clinical efficacy over time, which is likely to be important for a chronic and often lifelong viral disease. Administration with CELLECTRA, our proprietary electroporation device was well tolerated by patients and was considered easy to use by healthcare providers in 2 previous global Phase III trials. 3,107 also offers other important attributes typical of our DNA Medicines platform such as stability for up to 3 years at refrigerator temperature. Speaker 300:10:21We believe 3,107 represents a significant opportunity for Inovio in the U. S, Europe and rest of the world. As you can see here, in addition to its compelling product profile, there is significant unmet global need for treatment LYK-three thousand one hundred and seven. I'm pleased to report that we're making strong progress in key regions, including advancing our commercial preparations in the U. S. Speaker 300:10:41And making key regulatory progress in both Europe and K. We are going to be focused going forward on keeping this momentum going over the next quarter and look forward to sharing more in the coming months. Now I'll turn it over to Mike for some additional insights on 3,107 and a broader pipeline update. Mike? Thanks, Steve. Speaker 400:11:03We are really excited to have you on board. Before I dive in, I think it's important to provide a brief reminder about why we are working so hard to bring 3,107 to patients. This is a devastating disease that takes a huge toll on patients' health, time and emotional well-being. Repeated surgery and the repeated risk to vocal cords that comes with it is the mainstay of treatment. Patients are desperate and have said time and again that a reduction of even one surgery a year would be life changing. Speaker 400:11:40This is why we're working so hard to deliver on the promise of DNA medicine for the RRP community. As you've heard from Jackie, we have continued to make meaningful progress towards delivering 3,107 to patients. We expect to complete all non device related elements of our BLA package by the end of the year. Last week, we held our pre BLA meeting with the FDA, which I would characterize as being positive and supportive of our overall approach. With the device submission strategy for the CMC sections and the clinical components of our package. Speaker 400:12:22We are encouraged by the agency's level of engagement and have confidence that our approach and content for our BLA modules are on the right track. We also look forward to sharing important immunology data for 3,107 at 3 conferences in the 4th quarter. The Full Voice, a leading conference for clinicians focused on vocal disorders the 36th International Papillomavirus Conference, which is a platform designed for sharing cutting edge international HPV research and the International Society For Vaccines Annual Conference. While very pleased with this progress, we have unfortunately run into a manufacturing issue with a component of our CELLECTRA device. The single use disposable administration component otherwise known as the array. Speaker 400:13:19This is used to inject the DNA medicine and administer the electroporation. The issue stems from 1 of the plastic molded parts within this array and was identified during routine testing to support our BLA filing. This issue is not reflective of the broader safety and efficacy of our 5 PSP device or the array, which was used in 2 global Phase 3 studies. Our device teams with the support of our external component manufacturers are working to rapidly address the issue and then repeat the required testing for the array. The additional time needed for completing this work and testing has extended our anticipated timeline for BLA submission to mid-twenty 25. Speaker 400:14:11We will of course endeavor to complete this work on a faster timeline if possible and we'll have more updates for you at our next quarterly report. Moving on to our efforts to bring 3,107 to patients around the globe. We have made important progress as shown by our recent receipt of an advanced therapy medicinal product certification from the European Medicines Agency's Committee for Advanced Therapies. This is following review of our CMC and non clinical data. This certification confirms that the data reviewed complies with the standards that would be used to evaluate a European marketing authorization application and indicates that our work to advance 3,107 in Europe thus far is on the right track. Speaker 400:15:053,107 was also recently designated an innovative medicine as part of the UK's innovative licensing and access pathway. The designation called an innovation passport is the first step on a development pathway that offers enhanced access to regulators and development tools that could accelerate the timeline for achieving UK regulatory approval. This regulatory process builds on 3,107 receiving orphan drug designation in Europe in 2023. We will continue our conversations with regulators in ex U. S. Speaker 400:15:47Markets to frame the next steps for development of 3,107. European regulators have previously indicated that a placebo controlled study design such as the one we will conduct for our U. S. Confirmatory trial was their recommended pathway for potential licensure in the EU. This recommendation was one of the many reasons we selected a randomized placebo controlled design for our confirmatory study in the U. Speaker 400:16:16S. The use of a placebo controlled design enables us to include patients with only 2 surgeries in the prior year and does not require a year long observation period to establish a surgical baseline prior to commencement of treatment. We believe this clinical design strategy is highly representative of the broad spectrum of RRP disease and will likely be critical to support expansion into global markets. On a related note, we also successfully completed an unscheduled external quality system audit at our Mesa Ridge manufacturing site, which is required to maintain the company's ISO certification and CE mark for our Selectra device in the EU. The audit which occurred without prior warning or preparation time indicated that Inovio has a well established high functioning quality system. Speaker 400:17:19And the results provide further confidence that Inovio is on the right track in our preparations for global commercialization efforts. Turning now to one of our other promising late stage candidates, INO-three thousand one hundred and twelve. Last quarter, we received feedback from the FDA on our Phase 3 trial to investigate 3,112 as a potential treatment for HPV-sixteen and 18 related locoregionally advanced high risk throat cancer when used in combination with LOPTORZY, an anti PD-one monoclonal antibody recently approved for the treatment of nasopharyngeal carcinoma. We have continued to make progress with our plans to conduct a multicenter study in North America and Europe and have submitted the Phase 3 study package to European regulators. We believe this novel combination therapy has unique potential to meet the high unmet need within this rapidly growing patient group. Speaker 400:18:26The incidence of HPV positive throat cancer is on the rise in high income countries and has surpassed cervical cancer as the most common HPV related cancer diagnosed in the United States. Moving on to INO-four thousand two hundred and one, which is being studies as a heterologous boost to the FDA licensed Ebola vaccine of EVO. We plan to submit our Phase 2 and animal bridging study designs to the FDA for review later this month and are preparing to submit our Phase 1b trial data along with our collaborators to a peer reviewed journal. As I highlighted last quarter, we recently generated some encouraging new antibody response data from that trial by utilizing the FANG assay, which is the commonly utilized assay and indicated that 4,201 elicits a strong antibody response comparable to the AVEVO primary series vaccination. With that, I'll turn it over to Peter for a financial update for the quarter. Speaker 500:19:38Thank you, Mike. Today, I'd like to provide an overview of Inovio's operational highlights and financial condition for the Q2 of 2024. As Jackie noted at the start of the call, strengthening our financial position and business as a whole has been a critical part of our strategy to engage to enable us to focus on our internal resources and our late stage pipelines. I am pleased to report that we have again reduced our total operating spend dropping from $37,300,000 in the Q2 of 2023 to $33,300,000 in the Q2 of 2024 an almost 11% decrease. As noted last quarter, we paid the remaining balance of our convertible notes of $16,900,000 and have no debt on the balance sheet. Speaker 500:20:38Inovio's net loss for the quarter was $32,200,000 dollars or $1.19 per share basic and dilutive compared to a net loss of $35,500,000 or 1.61 dollars per share basic and dilutive for the Q2 of 2023. We finished the Q2 of 2024 with $110,400,000 in cash, cash equivalents and short term investments compared to $145,300,000 as of December 31, 2023. We estimate our cash runway to extend into the Q3 of 2025. This projection includes an operational net cash burn estimate of approximately 28,000,000 dollars for the Q3 of 2024. These cash runway projections do not include any further capital raise activities that Inovio may undertake. Speaker 500:21:43As a reminder, you can find our full financial statements in this afternoon's press release as well as in our Form 10 Q filed with the SEC. And with that, I'll turn it back to Jackie. Speaker 200:21:57Thanks, Peter. I'd now like to open up the call to answer any questions you might have. Operator? Operator00:22:07Thank you. Ladies and gentlemen, we will now begin the question and answer First question comes from the line of Gregory Renza with RBC Capital Markets. Please go ahead. Speaker 600:22:44Hi, Jackie and team. It's Anish on for Greg. Thanks for the updates and for taking our questions. Just a few from us on 3,107 and RRP and the manufacturing issues noted. Could you give us some more color on when along the timeline the noted manufacturing issues for the disposable administration component emerged and how it was detected? Speaker 600:23:04How is this reflected during your pre BLA discussions? And lastly, if you could help us understand the steps to resolve the issue and potential challenges you anticipate along the way? Thanks for the time. Speaker 200:23:16Hi, Anish. Nice to talk with you. So first of all, I'm happy to answer the questions about the recent manufacturing issue that's just come to light. And this has been a recent issue that we've literally just uncovered over the past week or couple of weeks as part of the BMV testing that's being conducted to support our BLA submission. So it's a very recent issue. Speaker 200:23:46And I think what I can say is that this issue is related to a plastic molded part that forms the part of the single use disposable array, which is the piece that's used to inject our DNA medicine and provide the electroporation. We are very confident that we'll be able to resolve this issue quickly. We're working with our external manufacturer who manufactures this component with us. And we're bringing all of our available resources to bear to solve this issue as quickly as possible. In terms of our recent BLA, I'll let Mike recent pre BLA meeting. Speaker 200:24:33I'll let Mike talk a bit more about that. Mike? Yes. Thank you, Jackie. Speaker 400:24:38So it wasn't part of our BLA into pre BLA interaction with the agency. And to be honest, I mean, as Jackie said, it arose fairly recently. But in the normal course of business, it would not be it would not have been part of the agenda for the pre BLA. I mean the pre BLA meeting was very much for us to align on the bigger picture of the components we need to include. As I mentioned in terms of sort of the overall device strategy, CMC and how we present the clinical components and we gained very good alignment from the agency with those. Speaker 400:25:17And really this recent issue will be an internal thing for us to appropriately fix the issue and document that we have fixed it adequately. And that will be part of our ongoing device verification. Speaker 200:25:34Yes. And Anish just to follow-up on the part of your question about why we've only just detected it now. So this issue occurs at a pretty low rate. And we picked it up as part of the VNB process, that's really designed to test all of the elements of the devices, part of the submission package that needs to go into the BLA. As we previously mentioned, we've used this device previously in 2 completed Phase III trials, globally. Speaker 200:26:04And that was those were trials that involved patients in more than 30 countries. So we have quite extensive experience with the device and the serrate component. Speaker 600:26:16Great. Thanks. Appreciate it. Operator00:26:20And your next question comes from the line of Roy Buchanan with Citizens GMP. Please go ahead. Speaker 700:26:28Hi, thanks Speaker 800:26:28for taking the questions. Just a couple of follow-up on the manufacturing. Just want to confirm that there's no expected impact to the timing or the conduct of the confirmatory trial. And it sounds like you maybe don't need to inform the FDA about this issue. Is that correct? Speaker 200:26:48Thanks Roy. Nice to talk with you. So in terms of timing of the confirmatory trial, we will need to resolve this issue before we can start dosing in the confirmatory trial. Mike, do you want to talk about the other element? Speaker 400:27:06Yes. So I mean, at the moment, the array is not being utilized in clinical practice. And so we will be resolving this as sort of part of our BLA filing aspects and we will obviously be sharing all the aspects of what we've done and how we've solved this issue with the FDA as part of our BLA filing. Speaker 800:27:34Okay. All right. Got it. All right. And then the immunological data that you're going to present at the 3 venues later this year, is that is it going to be all the same data or potentially one of the presentations going Speaker 900:27:47to be more impactful than the other? Speaker 400:27:52That's it. So I think where we have really focused our immunological data is at IPVC. But and that will be certainly very new data than we've presented before and really sort of confirm what we've spoken to and that we are seeing a difference in our immunological profile between responders and non responders. And I think it also really talks to the mechanism of action of 3,107. So we're very excited to present that upcoming data. Speaker 800:28:30Okay, great. And then last one for me and I'll jump back. The 3,107 Phase 3, have you discussed the design of that trial with the European regulators yet? Speaker 200:28:44Mike, do you want to? Speaker 400:28:45Yes. So I mean as part of our original submission, we did discuss clinical strategy and we do have alignment on how to approach the clinical aspects of a future filing. And as you heard me talk to today, one of the most significant elements of that was the placebo controlled nature of the study, which was really what guided us to do that as part of our U. S. Confirmatory study, along with the fact we were very keen to include patients who only had 2 surgeries in the prior year as we had done with our Phase onetwo study and believe that that really enables more treat patients to hopefully excess treatment in the future. Operator00:29:32Thank Speaker 800:29:35you. Speaker 300:29:38Thank you. Operator00:29:39And your next Thank you. And your next question comes from the line of Jay Olson with Oppenheimer. Please go ahead. Speaker 1000:29:45Hey, thank you for providing this update. We also had a couple of questions about the array device for 3,107. Will the manufacturing issue have any impact on the UK or European regulatory progress? And will it have any impact on operating expenses in the next few quarters? And then I had a follow-up. Speaker 200:30:08Yes. Great question, Jay and nice to hear from you. So we're really focused on resolving this issue as quickly as possible. We're putting all of our available resources into moving it forward as quickly as possible. Part of the reason why it's going to take some time is we have to rectify the issue and then we have to complete the testing that's required to support our BLA submission. Speaker 200:30:35And until we've completed that work, we're not going to be in a position to start our confirmatory trial. So in terms of the order of the different regulatory submissions, we're really focused on getting that confirmatory trial started in the U. S. First and that's really what's gating our progress at the moment. Speaker 1000:30:56Okay, great. Thank you. Speaker 400:30:57I was Speaker 1000:30:58super happy. Speaker 200:31:00Yes. And moving on in terms of operating expense, clearly this is a recent issue. We're bringing the resources to bear that we need to bring to bear to solve it. I think we'll be able to provide a bit more update on operating expenses on next call in November. Speaker 1000:31:21Okay. Thank you. We'll look forward to that. And then with regards to the RRP redosing study, would you plan to conduct that redosing study as part of the confirmatory study or would that be a separate trial? Speaker 200:31:36Yes, that's a great question, Jay. And we've tried to be pretty clear on that in the past. We view this as a separate study and we're not planning to conduct it as part of our confirmatory trial. Speaker 1000:31:49Okay, understood. Thank you very much. Operator00:32:04And your next question comes from the line of Sudan Loganathan with Stephens. Please go ahead. Speaker 900:32:11Hi, Nova your team. Thank you in advance for taking my questions. I have a few questions. First on the 3,107 manufacturing of the array part. If you only are using 1 third party manufacturer for this component, what would be the ramp up time to probably get another one started as a backup for this array in case the issues cannot be resolved to yours or the agency standards with this with the 1 the 3rd party that you're using currently. Speaker 900:32:36Just trying to get a feel for the sense of complexity of manufacturing this component. Speaker 200:32:43Yes. That's a great question Sudan. From my perspective and this is a recent issue, so I don't want to go into too much detail here. But from my perspective, we think that we have a pretty straightforward path to resolve this issue. I don't think at this stage it's going to be necessary to get another manufacturer up and ready to manufacture this part. Speaker 200:33:13I think it's more a case of working through this issue with the existing manufacturer. Speaker 900:33:20Got it. Thank you. And my last one, just staying on 3,107 opportunity OUS, can you update us on the significance of the innovation passport granted from the UK? And probably name some examples of some other notable drugs that may have also received this designation and the potential read through this could have for 3,107 launch in the OUS markets? And just kind of based on this potential delay in the U. Speaker 900:33:45S. BLA filing, could there be the first of 3107 OUS markets as early as late next year or early 2026? Speaker 200:33:56Again, great questions. I'll hand you over to Mike to talk about the ILAP pathway. But this is a relatively new mechanism that's come out really after Brexit to be honest. So but I'll hand you over to Mike. Yes, absolutely. Speaker 200:34:11So I see this pathway Speaker 400:34:13sort of similar to breakthrough therapy designation where you get increased access to the regulators to discuss your regulatory pathway. They do hint to the fact that there might be a sort of accelerated approval pathway, but we need we have not actually had that face to face discussion with them yet. That is upcoming and hopefully we'll be able to provide greater clarity on that at our next earnings call. But we're very excited. It's a great honor I think for us. Speaker 400:34:51I mean, we were excited about breakthrough therapy designation. It's nice to have another regulatory body acknowledge the uniqueness and how special our clinical data is to this patient population. I think we just need to wait and give you a little more guidance on that at our next earnings call. But we'll certainly look into what other drugs have received the same designation and let you know. But I don't think any drug to date has actually been approved under this pathway. Speaker 400:35:27But we'll confirm that. Speaker 900:35:32Thank you. I appreciate the Operator00:35:45Your next question comes from the line of Yi Chen with H. C. Wainwright. Please go ahead. Speaker 700:35:53Just to confirm that currently you plan to initiate both the confirmatory trial and the redosing trial towards mid-twenty 25, correct? Speaker 400:36:08So, we have always said that the confirmatory the re dosing study is going to be a post approval study. And the basis of that is, as you've seen from our Phase onetwo study, we had very significant efficacy in that study. And so to actually show enhancement on the already very good results, we're going to have to have a larger sample size. And so we always felt that they would be easier to achieve that study once we have the product approved and on the market and there are greater number of subjects that could actually be recruited into that study following receiving our primary series. Speaker 700:36:54Got it. So just confirmatory trial before the BOS submission. Is the redosing trial required by required for regulatory submission in Europe or UK? Speaker 400:37:09No. This is just our desire to further enhance our efficacy in line with what the RRP foundation want for their patients, a significant reduction in surgeries and every surgery matters to those patients. So if we can enhance our efficacy with further dosing beyond, we're already seeing 81% of patients respond. We're seeing 72% of patients have greater than 50% reduction. So you can now see why we need that larger population that we can only achieve post approval. Speaker 200:37:49And yes, I think when we publish our immunology data and are making those presentations at the upcoming conferences later on this year. I think you'll see from the immunology data that we're putting out there that we believe we have a good understanding of what are the immune responses that are driving that clinical benefit. So as Mike says, really what we're looking to do here is to get the relatively small number of people who are not responders at this time into response. And also importantly for what is a chronic potentially lifelong viral disease, make sure that we can maintain that production and protection and reduction for as long as it's necessary. So I think it's an important part of the life cycle management of 3,107. Speaker 700:38:45Got it. And lastly, do you currently have an estimated timeframe for regulatory submission in Europe and U. K? Is it going to be before or post FDA approval in the U. S? Speaker 400:39:03We haven't really guided to that at this moment in time. Speaker 700:39:08Okay. Thank you. Operator00:39:12And there are no further questions at this time. I would like to turn it back to Doctor. Jackie Hsieh for closing remarks. Speaker 200:39:21Thank you. I'd like to close today by reiterating that although we've met an unexpected challenge in our goal to submit our BLA for 3,107 by the end of this year, I'm confident in our team's ability to rapidly resolve the issue, and we remain focused on the opportunity to deliver a potentially life changing therapy for RRP. As I've highlighted previously, we believe that Inovio has the key drivers for success in place and we will leverage them to continue making progress on both near and long term key objectives to deliver value to all stakeholders. And as always, the transformational potential of DNA Medicine and the patients that could benefit from it continues to provide the inspiration to drive us forward. Have a good evening everyone. Operator00:40:13Thank you. And ladies and gentlemen, this concludes today's conference call. Thank you all for participating. You may now disconnect.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallInovio Pharmaceuticals Q2 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Inovio Pharmaceuticals Earnings HeadlinesInovio Pharmaceuticals Inc. stock rises Friday, still underperforms marketApril 11, 2025 | marketwatch.comNext-generation Covid-19 vaccines currently being testedApril 11, 2025 | finance.yahoo.comMusk’s AI Masterplan – Our #1 AI Stock to Buy NowDid Elon Musk just set the stage for the next AI stock explosion? One 30-year Wall Street veteran thinks so. 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Email Address About Inovio PharmaceuticalsInovio Pharmaceuticals (NASDAQ:INO), a biotechnology company, focuses on the discovery, development, and commercialization of DNA medicines to treat and protect people from diseases associated with human papillomavirus (HPV), cancer, and infectious diseases. Its DNA medicines platform uses precisely designed SynCon that identify and optimize the DNA sequence of the target antigen, as well as CELLECTRA smart devices technology that facilitates delivery of the DNA plasmids. Its products in pipeline include VGX-3100 for the treatment of HPV-related cervical high-grade dysplasia; INO-3107 for HPV-related recurrent respiratory papillomatosis and is under Phase 1/2 trial; INO-3112 for the treatment of HPV-related Oropharyngeal Squamous Cell Carcinoma and is under Phase 2 trial; INO-5401 for the treatment of glioblastoma multiforme and is under Phase 2 trial; INO-4201 for Ebola Virus Disease and is under Phase 1b trial; INO-4800 for COVID-19 and is under Phase 3 trial; and INO-6160 for the treatment of human immunodeficiency virus and is under Phase 1 trial. Its partners and collaborators include Advaccine Biopharmaceuticals Suzhou Co, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations, Defense Advanced Research Projects Agency, The U.S. Department of Defense, HIV Vaccines Trial Network, International Vaccine Institute, Kaneka Eurogentec, National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron Pharmaceuticals, Richter-Helm BioLogics, Thermo Fisher Scientific, the University of Pennsylvania, the Walter Reed Army Institute of Research, and The Wistar Institute. 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There are 11 speakers on the call. Operator00:00:00Good afternoon, ladies and gentlemen, and welcome to the Indovio Second Quarter 20 24 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. This call is being recorded on Thursday, August 8, 2024. I would now like to turn the conference over to Thomas Hong, Manager of Investor Relations. Operator00:00:32Please go ahead. Speaker 100:00:35Thank you. Operator00:00:36Good afternoon, ladies and gentlemen, and thank you for joining us for Acacia Research Second Quarter 2024 Earnings Conference Call. My name is Prilla, and I will be your conference operator today. All lines are currently on mute to prevent any background noise. I would like to remind you that this conference is being recorded today and is available through audio webcast on the company's website. Following the speakers' remarks, there will be time for questions. Operator00:01:01Analysts and investors are reminded that any additional inquiries Speaker 200:01:19Hello, operator? Operator00:01:38Good afternoon, ladies and gentlemen, and welcome to the Indovio Second 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. This call is being recorded on Thursday, August 8, 2024. I would now like to turn the conference over to Thomas Hall, Manager of Investor Relations. Operator00:02:11Please go ahead. Speaker 100:02:15Good afternoon and thank you for joining the Inovio's Q2 2024 Financial Results Conference Call. Joining me on today's call are Doctor. Jackie Hsieh, President and Chief Executive Officer Doctor. Michael Sumner, Chief Medical Officer Peter Kies, Chief Financial Officer and Steve Agee, Chief Commercial Officer. Today's call will review our corporate and financial information for the quarter ended June 30, 2024, as well as provide a general business update. Speaker 100:02:47Following 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. Speaker 100:03:22We 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. Will now turn the call over to Innovia's President and CEO, Doctor. Jackie Shea. Speaker 200:03:53Thank you, Thomas. Good afternoon, and thank you to everyone for joining today's call. To begin with today, I'd like to discuss the progress we've made thus far for 2024 based on the goals we set out at the beginning of this year. That includes advancing our lead INO-three thousand one hundred and seven development program, advancing other promising candidates in our pipeline and finally strengthening our business as a whole. Our primary focus has been working towards the potential commercialization of 3,107 for the treatment of recurrent respiratory papillomatosis or RRP. Speaker 200:04:36We have made significant progress preparing our BLA package and expect all non device related elements to be completed by year end. A positive pre BLA meeting with the FDA last week provided us with further confidence that we remain on the right track for submission. We've also made important regulatory progress in both UK and Europe and have continued to advance planning for our re dosing trial. However, as announced earlier today, we have identified a manufacturing issue with a single use disposable administration component of our device during the testing process required to support our BLA filing and that will impact the timing of our BLA submission. Every day matters to patients and we're working to resolve this issue as quickly as possible. Speaker 200:05:31Our Chief Medical Officer and RRP Program Lead, Mike Sumner will provide more details. But I want to emphasize that we're confident in our path forward and remain focused on the opportunity to deliver not only what could be the 1st FDA approved therapy for this devastating disease, but the 1st DNA medicine approved for use in the United States. What's more, Inovio has continued making progress on other key objectives for both the near and longer term to deliver value to stakeholders. Elsewhere in our pipeline, we've submitted our Phase III trial design for INO-three thousand one hundred and twelve in combination with LOPTORZY for the treatment of throat cancer to the European Medicines Agency for review. We're also planning to submit our Phase 2 trial for INO-four thousand two hundred and one as an Ebola vaccine booster to the FDA later this month and have advanced discussions with partners for the next trial for INO-five thousand four hundred and one in glioblastoma, a deadly brain cancer. Speaker 200:06:38At the same time, we've continued to strengthen our business by prioritizing financial discipline and operational excellence. As Peter will discuss shortly, we closed the Q2 with $110,000,000 in cash and short term investments with no debt on our balance sheet and raised approximately $33,000,000 through an offering of common stock and prefunded warrants this past April. We estimate that our current cash will be sufficient to fund our operations into the Q3 of 2025. We also recently welcomed Steve Eggie as our new Chief Commercial Officer and I'm delighted to have him join our leadership team. Steve has broad therapeutic area experience including in HPV related diseases in cancers, vaccines and rare disease And his career has spanned both biotech and large pharma. Speaker 200:07:34Steve recently launched a new women's health product at Myovant Sciences, which was later acquired by Sumitomo Pharma. He also spent 20 years at Merck, where he held a number of senior commercial leadership roles, including leading their HPV vaccines franchise and serving as Chief Marketing Officer for the Vaccine Division. Over the course of his career, he has overseen or contributed to more than a dozen commercial product launches. His broad commercial expertise will be invaluable as we work to advance 3,107 and our other promising candidates. I'd like to invite Steve to share more about why he joined Inovio and the potential he sees for 3,107. Speaker 200:08:16Steve? Speaker 300:08:18Thank you, Jackie, and hello, everyone. I'd like to start by saying how excited I am to be here and to be leading the very talented commercial team at Inovio, working to advance a lead candidate that I believe could transform the lives of people living with RRP and potentially bring the first DNA medicine to patients in the United States. I spent my career getting innovative medicines to market for patients with significant unmet medical needs and I believe 3,107 offers a compelling product profile that could make it the preferred choice for the broadest number of RRP patients, healthcare providers and payers. 3,107 demonstrated significant impact in our Phase onetwo trial where over 80% of patients across the disease severity continuum had a reduction in the number of surgeries compared to the previous year. It's important to note that our treatment regimen does not require surgeries during the dosing window to maintain minimal residual disease. Speaker 300:09:153,107 also targets and has shown efficacy against both HPV-six and 11, which cause RRP. 3,107 has demonstrated the ability to generate antigen specific T cells in patients that we believe leads to reduction in surgery by eliminating infected cells, thus preventing the papillomas from growing back. As DNA medicines do not generate anti vector immunity, we believe we will have the potential to redose 3,107 if needed to maintain or enhance clinical efficacy over time, which is likely to be important for a chronic and often lifelong viral disease. Administration with CELLECTRA, our proprietary electroporation device was well tolerated by patients and was considered easy to use by healthcare providers in 2 previous global Phase III trials. 3,107 also offers other important attributes typical of our DNA Medicines platform such as stability for up to 3 years at refrigerator temperature. Speaker 300:10:21We believe 3,107 represents a significant opportunity for Inovio in the U. S, Europe and rest of the world. As you can see here, in addition to its compelling product profile, there is significant unmet global need for treatment LYK-three thousand one hundred and seven. I'm pleased to report that we're making strong progress in key regions, including advancing our commercial preparations in the U. S. Speaker 300:10:41And making key regulatory progress in both Europe and K. We are going to be focused going forward on keeping this momentum going over the next quarter and look forward to sharing more in the coming months. Now I'll turn it over to Mike for some additional insights on 3,107 and a broader pipeline update. Mike? Thanks, Steve. Speaker 400:11:03We are really excited to have you on board. Before I dive in, I think it's important to provide a brief reminder about why we are working so hard to bring 3,107 to patients. This is a devastating disease that takes a huge toll on patients' health, time and emotional well-being. Repeated surgery and the repeated risk to vocal cords that comes with it is the mainstay of treatment. Patients are desperate and have said time and again that a reduction of even one surgery a year would be life changing. Speaker 400:11:40This is why we're working so hard to deliver on the promise of DNA medicine for the RRP community. As you've heard from Jackie, we have continued to make meaningful progress towards delivering 3,107 to patients. We expect to complete all non device related elements of our BLA package by the end of the year. Last week, we held our pre BLA meeting with the FDA, which I would characterize as being positive and supportive of our overall approach. With the device submission strategy for the CMC sections and the clinical components of our package. Speaker 400:12:22We are encouraged by the agency's level of engagement and have confidence that our approach and content for our BLA modules are on the right track. We also look forward to sharing important immunology data for 3,107 at 3 conferences in the 4th quarter. The Full Voice, a leading conference for clinicians focused on vocal disorders the 36th International Papillomavirus Conference, which is a platform designed for sharing cutting edge international HPV research and the International Society For Vaccines Annual Conference. While very pleased with this progress, we have unfortunately run into a manufacturing issue with a component of our CELLECTRA device. The single use disposable administration component otherwise known as the array. Speaker 400:13:19This is used to inject the DNA medicine and administer the electroporation. The issue stems from 1 of the plastic molded parts within this array and was identified during routine testing to support our BLA filing. This issue is not reflective of the broader safety and efficacy of our 5 PSP device or the array, which was used in 2 global Phase 3 studies. Our device teams with the support of our external component manufacturers are working to rapidly address the issue and then repeat the required testing for the array. The additional time needed for completing this work and testing has extended our anticipated timeline for BLA submission to mid-twenty 25. Speaker 400:14:11We will of course endeavor to complete this work on a faster timeline if possible and we'll have more updates for you at our next quarterly report. Moving on to our efforts to bring 3,107 to patients around the globe. We have made important progress as shown by our recent receipt of an advanced therapy medicinal product certification from the European Medicines Agency's Committee for Advanced Therapies. This is following review of our CMC and non clinical data. This certification confirms that the data reviewed complies with the standards that would be used to evaluate a European marketing authorization application and indicates that our work to advance 3,107 in Europe thus far is on the right track. Speaker 400:15:053,107 was also recently designated an innovative medicine as part of the UK's innovative licensing and access pathway. The designation called an innovation passport is the first step on a development pathway that offers enhanced access to regulators and development tools that could accelerate the timeline for achieving UK regulatory approval. This regulatory process builds on 3,107 receiving orphan drug designation in Europe in 2023. We will continue our conversations with regulators in ex U. S. Speaker 400:15:47Markets to frame the next steps for development of 3,107. European regulators have previously indicated that a placebo controlled study design such as the one we will conduct for our U. S. Confirmatory trial was their recommended pathway for potential licensure in the EU. This recommendation was one of the many reasons we selected a randomized placebo controlled design for our confirmatory study in the U. Speaker 400:16:16S. The use of a placebo controlled design enables us to include patients with only 2 surgeries in the prior year and does not require a year long observation period to establish a surgical baseline prior to commencement of treatment. We believe this clinical design strategy is highly representative of the broad spectrum of RRP disease and will likely be critical to support expansion into global markets. On a related note, we also successfully completed an unscheduled external quality system audit at our Mesa Ridge manufacturing site, which is required to maintain the company's ISO certification and CE mark for our Selectra device in the EU. The audit which occurred without prior warning or preparation time indicated that Inovio has a well established high functioning quality system. Speaker 400:17:19And the results provide further confidence that Inovio is on the right track in our preparations for global commercialization efforts. Turning now to one of our other promising late stage candidates, INO-three thousand one hundred and twelve. Last quarter, we received feedback from the FDA on our Phase 3 trial to investigate 3,112 as a potential treatment for HPV-sixteen and 18 related locoregionally advanced high risk throat cancer when used in combination with LOPTORZY, an anti PD-one monoclonal antibody recently approved for the treatment of nasopharyngeal carcinoma. We have continued to make progress with our plans to conduct a multicenter study in North America and Europe and have submitted the Phase 3 study package to European regulators. We believe this novel combination therapy has unique potential to meet the high unmet need within this rapidly growing patient group. Speaker 400:18:26The incidence of HPV positive throat cancer is on the rise in high income countries and has surpassed cervical cancer as the most common HPV related cancer diagnosed in the United States. Moving on to INO-four thousand two hundred and one, which is being studies as a heterologous boost to the FDA licensed Ebola vaccine of EVO. We plan to submit our Phase 2 and animal bridging study designs to the FDA for review later this month and are preparing to submit our Phase 1b trial data along with our collaborators to a peer reviewed journal. As I highlighted last quarter, we recently generated some encouraging new antibody response data from that trial by utilizing the FANG assay, which is the commonly utilized assay and indicated that 4,201 elicits a strong antibody response comparable to the AVEVO primary series vaccination. With that, I'll turn it over to Peter for a financial update for the quarter. Speaker 500:19:38Thank you, Mike. Today, I'd like to provide an overview of Inovio's operational highlights and financial condition for the Q2 of 2024. As Jackie noted at the start of the call, strengthening our financial position and business as a whole has been a critical part of our strategy to engage to enable us to focus on our internal resources and our late stage pipelines. I am pleased to report that we have again reduced our total operating spend dropping from $37,300,000 in the Q2 of 2023 to $33,300,000 in the Q2 of 2024 an almost 11% decrease. As noted last quarter, we paid the remaining balance of our convertible notes of $16,900,000 and have no debt on the balance sheet. Speaker 500:20:38Inovio's net loss for the quarter was $32,200,000 dollars or $1.19 per share basic and dilutive compared to a net loss of $35,500,000 or 1.61 dollars per share basic and dilutive for the Q2 of 2023. We finished the Q2 of 2024 with $110,400,000 in cash, cash equivalents and short term investments compared to $145,300,000 as of December 31, 2023. We estimate our cash runway to extend into the Q3 of 2025. This projection includes an operational net cash burn estimate of approximately 28,000,000 dollars for the Q3 of 2024. These cash runway projections do not include any further capital raise activities that Inovio may undertake. Speaker 500:21:43As a reminder, you can find our full financial statements in this afternoon's press release as well as in our Form 10 Q filed with the SEC. And with that, I'll turn it back to Jackie. Speaker 200:21:57Thanks, Peter. I'd now like to open up the call to answer any questions you might have. Operator? Operator00:22:07Thank you. Ladies and gentlemen, we will now begin the question and answer First question comes from the line of Gregory Renza with RBC Capital Markets. Please go ahead. Speaker 600:22:44Hi, Jackie and team. It's Anish on for Greg. Thanks for the updates and for taking our questions. Just a few from us on 3,107 and RRP and the manufacturing issues noted. Could you give us some more color on when along the timeline the noted manufacturing issues for the disposable administration component emerged and how it was detected? Speaker 600:23:04How is this reflected during your pre BLA discussions? And lastly, if you could help us understand the steps to resolve the issue and potential challenges you anticipate along the way? Thanks for the time. Speaker 200:23:16Hi, Anish. Nice to talk with you. So first of all, I'm happy to answer the questions about the recent manufacturing issue that's just come to light. And this has been a recent issue that we've literally just uncovered over the past week or couple of weeks as part of the BMV testing that's being conducted to support our BLA submission. So it's a very recent issue. Speaker 200:23:46And I think what I can say is that this issue is related to a plastic molded part that forms the part of the single use disposable array, which is the piece that's used to inject our DNA medicine and provide the electroporation. We are very confident that we'll be able to resolve this issue quickly. We're working with our external manufacturer who manufactures this component with us. And we're bringing all of our available resources to bear to solve this issue as quickly as possible. In terms of our recent BLA, I'll let Mike recent pre BLA meeting. Speaker 200:24:33I'll let Mike talk a bit more about that. Mike? Yes. Thank you, Jackie. Speaker 400:24:38So it wasn't part of our BLA into pre BLA interaction with the agency. And to be honest, I mean, as Jackie said, it arose fairly recently. But in the normal course of business, it would not be it would not have been part of the agenda for the pre BLA. I mean the pre BLA meeting was very much for us to align on the bigger picture of the components we need to include. As I mentioned in terms of sort of the overall device strategy, CMC and how we present the clinical components and we gained very good alignment from the agency with those. Speaker 400:25:17And really this recent issue will be an internal thing for us to appropriately fix the issue and document that we have fixed it adequately. And that will be part of our ongoing device verification. Speaker 200:25:34Yes. And Anish just to follow-up on the part of your question about why we've only just detected it now. So this issue occurs at a pretty low rate. And we picked it up as part of the VNB process, that's really designed to test all of the elements of the devices, part of the submission package that needs to go into the BLA. As we previously mentioned, we've used this device previously in 2 completed Phase III trials, globally. Speaker 200:26:04And that was those were trials that involved patients in more than 30 countries. So we have quite extensive experience with the device and the serrate component. Speaker 600:26:16Great. Thanks. Appreciate it. Operator00:26:20And your next question comes from the line of Roy Buchanan with Citizens GMP. Please go ahead. Speaker 700:26:28Hi, thanks Speaker 800:26:28for taking the questions. Just a couple of follow-up on the manufacturing. Just want to confirm that there's no expected impact to the timing or the conduct of the confirmatory trial. And it sounds like you maybe don't need to inform the FDA about this issue. Is that correct? Speaker 200:26:48Thanks Roy. Nice to talk with you. So in terms of timing of the confirmatory trial, we will need to resolve this issue before we can start dosing in the confirmatory trial. Mike, do you want to talk about the other element? Speaker 400:27:06Yes. So I mean, at the moment, the array is not being utilized in clinical practice. And so we will be resolving this as sort of part of our BLA filing aspects and we will obviously be sharing all the aspects of what we've done and how we've solved this issue with the FDA as part of our BLA filing. Speaker 800:27:34Okay. All right. Got it. All right. And then the immunological data that you're going to present at the 3 venues later this year, is that is it going to be all the same data or potentially one of the presentations going Speaker 900:27:47to be more impactful than the other? Speaker 400:27:52That's it. So I think where we have really focused our immunological data is at IPVC. But and that will be certainly very new data than we've presented before and really sort of confirm what we've spoken to and that we are seeing a difference in our immunological profile between responders and non responders. And I think it also really talks to the mechanism of action of 3,107. So we're very excited to present that upcoming data. Speaker 800:28:30Okay, great. And then last one for me and I'll jump back. The 3,107 Phase 3, have you discussed the design of that trial with the European regulators yet? Speaker 200:28:44Mike, do you want to? Speaker 400:28:45Yes. So I mean as part of our original submission, we did discuss clinical strategy and we do have alignment on how to approach the clinical aspects of a future filing. And as you heard me talk to today, one of the most significant elements of that was the placebo controlled nature of the study, which was really what guided us to do that as part of our U. S. Confirmatory study, along with the fact we were very keen to include patients who only had 2 surgeries in the prior year as we had done with our Phase onetwo study and believe that that really enables more treat patients to hopefully excess treatment in the future. Operator00:29:32Thank Speaker 800:29:35you. Speaker 300:29:38Thank you. Operator00:29:39And your next Thank you. And your next question comes from the line of Jay Olson with Oppenheimer. Please go ahead. Speaker 1000:29:45Hey, thank you for providing this update. We also had a couple of questions about the array device for 3,107. Will the manufacturing issue have any impact on the UK or European regulatory progress? And will it have any impact on operating expenses in the next few quarters? And then I had a follow-up. Speaker 200:30:08Yes. Great question, Jay and nice to hear from you. So we're really focused on resolving this issue as quickly as possible. We're putting all of our available resources into moving it forward as quickly as possible. Part of the reason why it's going to take some time is we have to rectify the issue and then we have to complete the testing that's required to support our BLA submission. Speaker 200:30:35And until we've completed that work, we're not going to be in a position to start our confirmatory trial. So in terms of the order of the different regulatory submissions, we're really focused on getting that confirmatory trial started in the U. S. First and that's really what's gating our progress at the moment. Speaker 1000:30:56Okay, great. Thank you. Speaker 400:30:57I was Speaker 1000:30:58super happy. Speaker 200:31:00Yes. And moving on in terms of operating expense, clearly this is a recent issue. We're bringing the resources to bear that we need to bring to bear to solve it. I think we'll be able to provide a bit more update on operating expenses on next call in November. Speaker 1000:31:21Okay. Thank you. We'll look forward to that. And then with regards to the RRP redosing study, would you plan to conduct that redosing study as part of the confirmatory study or would that be a separate trial? Speaker 200:31:36Yes, that's a great question, Jay. And we've tried to be pretty clear on that in the past. We view this as a separate study and we're not planning to conduct it as part of our confirmatory trial. Speaker 1000:31:49Okay, understood. Thank you very much. Operator00:32:04And your next question comes from the line of Sudan Loganathan with Stephens. Please go ahead. Speaker 900:32:11Hi, Nova your team. Thank you in advance for taking my questions. I have a few questions. First on the 3,107 manufacturing of the array part. If you only are using 1 third party manufacturer for this component, what would be the ramp up time to probably get another one started as a backup for this array in case the issues cannot be resolved to yours or the agency standards with this with the 1 the 3rd party that you're using currently. Speaker 900:32:36Just trying to get a feel for the sense of complexity of manufacturing this component. Speaker 200:32:43Yes. That's a great question Sudan. From my perspective and this is a recent issue, so I don't want to go into too much detail here. But from my perspective, we think that we have a pretty straightforward path to resolve this issue. I don't think at this stage it's going to be necessary to get another manufacturer up and ready to manufacture this part. Speaker 200:33:13I think it's more a case of working through this issue with the existing manufacturer. Speaker 900:33:20Got it. Thank you. And my last one, just staying on 3,107 opportunity OUS, can you update us on the significance of the innovation passport granted from the UK? And probably name some examples of some other notable drugs that may have also received this designation and the potential read through this could have for 3,107 launch in the OUS markets? And just kind of based on this potential delay in the U. Speaker 900:33:45S. BLA filing, could there be the first of 3107 OUS markets as early as late next year or early 2026? Speaker 200:33:56Again, great questions. I'll hand you over to Mike to talk about the ILAP pathway. But this is a relatively new mechanism that's come out really after Brexit to be honest. So but I'll hand you over to Mike. Yes, absolutely. Speaker 200:34:11So I see this pathway Speaker 400:34:13sort of similar to breakthrough therapy designation where you get increased access to the regulators to discuss your regulatory pathway. They do hint to the fact that there might be a sort of accelerated approval pathway, but we need we have not actually had that face to face discussion with them yet. That is upcoming and hopefully we'll be able to provide greater clarity on that at our next earnings call. But we're very excited. It's a great honor I think for us. Speaker 400:34:51I mean, we were excited about breakthrough therapy designation. It's nice to have another regulatory body acknowledge the uniqueness and how special our clinical data is to this patient population. I think we just need to wait and give you a little more guidance on that at our next earnings call. But we'll certainly look into what other drugs have received the same designation and let you know. But I don't think any drug to date has actually been approved under this pathway. Speaker 400:35:27But we'll confirm that. Speaker 900:35:32Thank you. I appreciate the Operator00:35:45Your next question comes from the line of Yi Chen with H. C. Wainwright. Please go ahead. Speaker 700:35:53Just to confirm that currently you plan to initiate both the confirmatory trial and the redosing trial towards mid-twenty 25, correct? Speaker 400:36:08So, we have always said that the confirmatory the re dosing study is going to be a post approval study. And the basis of that is, as you've seen from our Phase onetwo study, we had very significant efficacy in that study. And so to actually show enhancement on the already very good results, we're going to have to have a larger sample size. And so we always felt that they would be easier to achieve that study once we have the product approved and on the market and there are greater number of subjects that could actually be recruited into that study following receiving our primary series. Speaker 700:36:54Got it. So just confirmatory trial before the BOS submission. Is the redosing trial required by required for regulatory submission in Europe or UK? Speaker 400:37:09No. This is just our desire to further enhance our efficacy in line with what the RRP foundation want for their patients, a significant reduction in surgeries and every surgery matters to those patients. So if we can enhance our efficacy with further dosing beyond, we're already seeing 81% of patients respond. We're seeing 72% of patients have greater than 50% reduction. So you can now see why we need that larger population that we can only achieve post approval. Speaker 200:37:49And yes, I think when we publish our immunology data and are making those presentations at the upcoming conferences later on this year. I think you'll see from the immunology data that we're putting out there that we believe we have a good understanding of what are the immune responses that are driving that clinical benefit. So as Mike says, really what we're looking to do here is to get the relatively small number of people who are not responders at this time into response. And also importantly for what is a chronic potentially lifelong viral disease, make sure that we can maintain that production and protection and reduction for as long as it's necessary. So I think it's an important part of the life cycle management of 3,107. Speaker 700:38:45Got it. And lastly, do you currently have an estimated timeframe for regulatory submission in Europe and U. K? Is it going to be before or post FDA approval in the U. S? Speaker 400:39:03We haven't really guided to that at this moment in time. Speaker 700:39:08Okay. Thank you. Operator00:39:12And there are no further questions at this time. I would like to turn it back to Doctor. Jackie Hsieh for closing remarks. Speaker 200:39:21Thank you. I'd like to close today by reiterating that although we've met an unexpected challenge in our goal to submit our BLA for 3,107 by the end of this year, I'm confident in our team's ability to rapidly resolve the issue, and we remain focused on the opportunity to deliver a potentially life changing therapy for RRP. As I've highlighted previously, we believe that Inovio has the key drivers for success in place and we will leverage them to continue making progress on both near and long term key objectives to deliver value to all stakeholders. And as always, the transformational potential of DNA Medicine and the patients that could benefit from it continues to provide the inspiration to drive us forward. Have a good evening everyone. Operator00:40:13Thank you. And ladies and gentlemen, this concludes today's conference call. Thank you all for participating. You may now disconnect.Read morePowered by