Q2 2024 Inovio Pharmaceuticals Inc Earnings Call
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.
Speaker Change: I will now turn the call over to Inovio's President and CEO , Dr. Jackie Shea.
Jackie Shea: Thank you, Thomas. Good afternoon and thank you to everyone for joining today's call.
Jackie Shea: 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 INO3107 development program, advancing other promising candidates in our pipeline, and finally, strengthening our business as a whole.
Jackie Shea: Our primary focus has been working towards the potential commercialization of 3107 for the treatment of recurrent respiratory papillomatosis or RRP.
Jackie Shea: We have made significant progress preparing our BLA package and expect all non-device related elements to be completed by year end.
Jackie Shea: A positive pre-BLA meeting with the FDA last week provided us with further confidence that we remain on the right track for submission.
Jackie Shea: We've also made important regulatory progress in both the UK and Europe and have continued to advance planning for our re-dosing trials.
Jackie Shea: However, as announced earlier today, we have identified a manufacturing issue with the single-use disposable administration components of our device during the testing process required to support our BLA filing, and that will impact the timing of our BLA submission.
Jackie Shea: Every day matters to patients and we're working to resolve this issue as quickly as possible.
Mike Sumner: Our Chief Medical Officer and RRP Program Lead, Mike Sumner, will provide more details.
Mike Sumner: 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 first FDA-approved therapy for this devastating disease, but the first DNA medicine approved for use in the United States.
Jackie Shea: What's more, Inovio has continued making progress on other key objectives for both the near and longer term to deliver value to stakeholders.
Jackie Shea: Elsewhere in our pipeline, we've submitted our Phase III trial design for INO3112 in combination with Noctorzi for the treatment of throat cancer to the European Medicines Agency for review.
Jackie Shea: We're also planning to submit our Phase 2 trial for INO4201 as an Ebola vaccine booster to the FDA later this month.
Jackie Shea: And have advanced discussions with partners for the next trial for INO5401 in glioblastoma, a deadly brain cancer.
Jackie Shea: At the same time, we continue to strengthen our business by prioritizing financial discipline and operational excellence.
Speaker Change: As Peter will discuss shortly, we closed the second quarter with $110 million in cash and short-term investments, with no debt on our balance sheet, and raised approximately $33 million through an offering of common stock and pre-funded warrants this past April .
Peter: We estimate that our current cash will be sufficient to fund our operations into the third quarter of 2025.
Speaker Change: We also recently welcomed Steve Eggie as our new Chief Commercial Officer, and I'm delighted to have him join our leadership team.
Steve Beckett: Steve has broad therapeutic area experience, including in HPV-related diseases and cancers, vaccines, and rare disease, and his career has spanned both biotech and large pharma.
Speaker Change: Steve recently launched a new women's health product at My Advanced Sciences, which was later acquired by Sumitomo Pharma.
Speaker Change: 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.
Speaker Change: 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 3107 and are rather promising candidates.
Speaker Change: I'd like to invite Steve to share more about why he joined Inovio and the potential he sees for 3107.
Speaker Change: Steve.
Steve Beckett: Thank 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.
Speaker Change: I spent my career getting innovative medicines to market for patients with significant unmet medical needs, and I believe 3107 offers a compelling product profile that could make it the preferred choice for the broadest number of RRP patients, healthcare providers, and payers.
Speaker Change: 3107 demonstrated significant impact in our Phase 1-2 trial, where over 80% of patients across the disease severity continuum had a reduction in the number of surgeries compared to the previous year.
Speaker Change: It's important to note that our treatment regimen does not require surgeries during the dosing window to maintain minimal residual disease. 3107 also targets and has shown efficacy against both HPV6 and 11, which cause RRP.
Speaker Change: 3107 has demonstrated the ability to generate antigen-specific T cells in patients that we believe leads to a reduction in surgery by eliminating HPV-infected cells, thus preventing the papillomas from growing back.
Speaker Change: As DNA medicines do not generate anti-vector immunity, we believe we will have the potential to re-dose 3107, if needed, to maintain or enhance clinical efficacy over time, which is likely to be important for a chronic and often lifelong viral disease.
Speaker Change: Administration with Selectra, our proprietary electroporation device, was well tolerated by patients and was considered easy to use by health care providers in two previous global phase 3 trials.
Speaker Change: 3107 also offers other important attributes typical of our DNA medicines platform, such as stability for up to three years at refrigerator temperature.
Speaker Change: We believe 3107 represents a significant opportunity for Inovio in the U.S.
Speaker Change: Europe , and rest of the world.
Speaker Change: As you can see here, in addition to its compelling product profile, there is significant unmet global need for a treatment like 3107.
Speaker Change: I'm pleased to report that we're making strong progress in key regions, including advancing our commercial preparations in the U.S.
Speaker Change: and making key regulatory progress in both Europe and the UK. 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.
Speaker Change: Now, I'll turn it over to Mike for some additional insights on 3107 and a broader pipeline update. Mike? Thanks, Steve. We are really excited to have you on board.
Mike Sumner: Before I dive in, I think it's important to provide a brief reminder about why we are working so hard to bring 3107 to patients.
Speaker Change: This is a devastating disease that takes a huge toll on a patient's health, time, and emotional well-being.
Speaker Change: 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 Change: This is why we're working so hard to deliver on the promise of DNA medicine for the RRP community.
Speaker Change: As you've heard from Jackie, we have continued to make meaningful progress towards delivering 3107 to patients.
Speaker Change: We expect to complete all non-device related elements of our BLA package by the end of the year.
Speaker Change: 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 as submission strategy for the CMC sections and the clinical components of our package.
Speaker Change: We 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.
Speaker Change: We also look forward to sharing important immunology data for 3107 at three conferences in the fourth quarter. The Full Voice, a leading conference for clinicians focused on vocal disorders.
Speaker Change: The 36th International Papillomavirus Conference, which is a platform designed for sharing cutting-edge international HPV research.
Speaker Change: and the International Society for Vaccines Annual Conference.
Speaker Change: While very pleased with this progress, we have unfortunately run into a manufacturing issue with a component of our Selectra device, the Single-Use Disposable Administration Component, otherwise known as the Array.
Speaker Change: This is used to inject the DNA medicine and administer the electroporation.
Speaker Change: The issue stems from one of the plastic molded parts within this array and was identified during routine testing to support our BLA filing.
Speaker Change: This issue is not reflective of the broader safety and efficacy of our 5-PSB device or the array, which was used in two global Phase III studies.
Speaker Change: 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.
Speaker Change: The additional time needed for completing this work and testing has extended our anticipated timeline for BLA submission to mid-2025.
Speaker Change: We 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.
Speaker Change: Moving on to our efforts to bring 3107 to patients around the globe, we have made important progress as shown by our recent receipt of an Advanced Therapy Medicinal Product Certification.
Speaker Change: from the European Medicines Agency's Committee for Advanced Therapies.
Speaker Change: This is the following review of our CMC and non-clinical data.
Speaker Change: This certification confirms that the data reviewed complies with the standards that would be used to evaluate a European marketing authorization application.
Speaker Change: and indicates that our work to advance 3107 in Europe thus far is on the right track.
Speaker Change: 3107 was also recently designated an Innovative Medicine as part of the UK's Innovative Licensing and Access Pathway.
Speaker Change: 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.
Speaker Change: This regulatory process builds on 3107 receiving orphan drug designation in Europe in 2023.
Speaker Change: We will continue our conversations with regulators in ex-US markets to frame the next steps for development of 3107.
Speaker Change: 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.
Speaker Change: This recommendation was one of the many reasons we selected a randomized placebo-controlled design for our confirmatory study in the U.S.
Speaker Change: The use of a placebo-controlled design enables us to include patients with only two surgeries in the prior year, and does not require a year-long observation period to establish a surgical baseline prior to commencement of treatment.
Speaker Change: 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.
Speaker Change: On a related note, we also successfully completed an unscheduled external quality system audit at our Mesa Ridge manufacturing site.
Speaker Change: which is required to maintain the company's ISO certification and CE mark for a selected device in the EU.
Speaker Change: The audit, which occurred without prior warning or preparation time, indicated that Inovio has a well-established, high-functioning quality system.
Speaker Change: And the results provide further confidence that Inovio is on the right track in our preparations for global commercialization efforts.
Speaker Change: Turning now to one of our other promising late-stage candidates, INO 3112.
Speaker Change: Last quarter we received feedback from the FDA on our phase 3 trial to investigate 3112 as a potential treatment for HPV 16 and 18 related loco-regionally advanced high-risk throat cancer.
Speaker Change: when used in combination with Loctorzi, an anti-PD-1 monoclonal antibody.
Speaker Change: Recently approved for the treatment of nasopharyngeal carcinoma.
Speaker Change: We have continued to make progress with our plans to conduct a multi-center study in North America and Europe , and have submitted the Phase III study package to European regulators.
Speaker Change: We believe this novel combination therapy has unique potential to meet the high-armit need within this rapidly growing patient group.
Speaker Change: The 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.
Speaker Change: Moving on to INO4201, which is being studied as a heterologous boost to the FDA-licensed Ebola vaccine, Avibo.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: and indicated that 4201 elicits a strong antibody response comparable to the Avivo Primary Series vaccination.
Speaker Change: With that, I'll turn it over to Peter for a financial update for the quarter.
Peter: Thank you, Mike. Today I'd like to provide an overview of Inovio's operational highlights and financial condition for the second quarter of 2024.
Speaker Change: 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 enable us to focus on our internal resources and our late-stage pipelines.
Speaker Change: I am pleased
Speaker Change: to report that we have again reduced our total operating spend, dropping from $37.3 million in the second quarter of 2023 to $33.3 million in the second quarter of 2024, an almost 11% decrease.
Speaker Change: As noted last quarter, we paid the remaining balance of our convertible notes of $16.9 million and have no debt on the balance sheet.
Speaker Change: Inovio's net loss for the quarter was $32.2 million, or $1.19 per share, basic and dilutive, compared to a net loss of $35.5 million, or $1.61 per share.
Speaker Change: for share, basic and dilutive, for the second quarter of 2023.
Speaker Change: We finished the second quarter of 2024 with $110.4 million in cash, cash equivalents, and short-term investments, compared to $145.3 million as of December 31, 2023.
Speaker Change: We estimate our cash runway to extend into the third quarter of 2025. This projection includes an operational net cash
Speaker Change: burn estimate of approximately 28 million for the third quarter of 2024
Speaker Change: These cash runway projections do not include any further capital raise activities that Inovio may undertake.
Speaker Change: As 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.
Jackie Shea: Thanks Peter. I'd now like to open up the call to answer any questions you might have. Operator?
Speaker Change: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number 1 on your telephone keypad.
Speaker Change: You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the number 2. If you are using a speakerphone, please flip the handset before pressing any keys. One moment please for your first question.
Speaker Change: Thank you for watching, and I'll see you in the next video.
Speaker Change: The first question comes from the line of Gregory Renzo with RBC Capital Markets, please go ahead.
Speaker Change: Hi, Jackie and team, it's Anish on for Greg. Thanks for the updates and for taking our questions.
Anish: Just a few from us on 3107 and RRP and the manufacturing issues noted. Could you give us some more color on when along the timeline the noted manufacturing issues for
Speaker Change: the disposable administration component emerged and how it was detected.
Speaker Change: How 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 Change: Hi Anish, nice to talk with you.
Speaker Change: 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.
Speaker Change: as part of the B&B testing that's being conducted to support our BLA submission. So it's a very recent issue.
Speaker Change: And I think what I can say is that this issue is related to a
Speaker Change: 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.
Speaker Change: Um...
Mike Sumner: In terms of our recent BLA, I'll let Mike, our recent pre-BLA meeting, I'll let Mike talk a bit more about that. Mike? Yeah, thank you, Jackie. So it wasn't part of our BLA, pre-BLA interaction with the agency and to be honest, I mean, as Jackie said,
Mike Sumner: It arose fairly recently, but in the normal course of business 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.
Mike Sumner: and how we present the clinical components.
Mike Sumner: and we gained very good alignment from the agency with those.
Mike Sumner: And really this recent issue will be sort of 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.
Mike Sumner: Yeah, 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.
Mike Sumner: and we picked it up as part of the the V&V process.
Speaker Change: that's really designed to test all of the elements of the device as part of the submission package that needs to go into the BLA.
Mike Sumner: As we previously mentioned, we've used this device previously in two completed phase 3 trials globally, and those were trials that involved patients in more than 30 countries. So we have quite extensive experience with the device and this array component.
Speaker Change: Great. Thanks. Appreciate it.
Speaker Change: And your next question comes from the line up Roy Buchanan with Citizens GMP. Please go ahead.
Roy Buchanan: Hey, thanks for taking the questions. Just, yeah, a couple 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 Change: Thanks, Roy. Nice to talk with you.
Speaker Change: 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.
Speaker Change: Um...
Speaker Change: Mike, do you want to talk about the other element? Yes, so I mean at the moment the the array is not being utilized in clinical practice And so, you know, we we will be resolving this as sort of part of their
Mike Sumner: BLA filing aspects and we will obviously be sharing all the 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 Change: Okay, all right, got it. All right, and then the immunological data that you're going to present at the three venues later this year, is that, they're going to be all the same data or potentially one of the presentations going to be more impactful than the other?
Speaker Change: i
Speaker Change: So I think where we have really focused our immunological data is at IPVC.
Speaker Change: But, you know, and that will be certainly very new data than we've presented before.
Speaker Change: and really sort of confirm what we've spoken to in that we are seeing a difference in our immunological...
Speaker Change: Profile between responders and non-responders, and I think it also really talks to the mechanism of action of 3107. So we're very excited to present that upcoming data.
Speaker Change: Okay, great. And then last one for me, and I'll jump back. The 3107 Phase III, have you discussed the design of that trial with the European regulators yet?
Speaker Change: Mike, do you want to... Yeah, 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.
Speaker Change: of a future filing and, you know, as you heard me talk to today.
Mike Sumner: One of the most significant elements of that was the placebo-controlled nature of the study.
Speaker Change: 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.
Speaker Change: who only had two surgeries in the prior year as we had done with our Phase 1-2 study and believe that, you know, that really enables more patients to hopefully access treatment in the future.
Mike Sumner: Thank you.
Speaker Change: Thank you. And your next question comes from the line of Jay Olsen with Oppenheimer. Please go ahead.
Jay Olsen: Oh hey, thank you for providing this update. We also had a couple questions about the array device for 3107.
Jay Olsen: 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 Change: Yeah, great questions 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.
Jay Olsen: You know, 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. And until we've...
Jay Olsen: completed that work we're not going to be in a position to start our confirmatory trial.
Jay Olsen: 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 Change: Okay, great, thank you, that was super helpful.
Speaker Change: Yeah and you know moving on in terms of operating expense you know clearly this is a recent issue we get you know 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 and operating expenses our next call
Jay Olsen: in November .
Speaker Change: Okay, thank you. We'll look forward to that. And then, with regards to the RRP re-dosing study, would you plan to conduct that re-dosing study as part of the confirmatory study, or would that be a separate trial?
Shea: Yeah, that's a great question, Jay, and we've tried to be pretty clear on that in the past, but we view this as a separate study and we're not planning to conduct it as part of our confirmatory trial.
Shea: Okay, understood. Thank you very much.
Speaker Change: I'll be back with you in the next video.
Shea: www.InnovationBank.com
Speaker Change: And your next question comes from the line of Sudhan Loganathan with Stations. Please go ahead.
Sudhan Loganathan: Hi, Inovio team. Thank you in advance for taking my questions. I have a few questions. First, on the 3107 manufacturing of the array part, if you only are using one 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 the one third-party that you're using currently? Just trying to get a feel for the sense of complexity of manufacturing this component.
Sudhan Loganathan: Yeah, that's a great question, Sudhana.
Speaker Change: You know, from my perspective, and, you know, 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.
Speaker Change: I don't think at this stage it's going to be necessary to get another manufacturer up and ready to manufacture this part. I think it's more a case of working through this issue with the existing manufacturer.
Speaker Change: And my last one, just staying on 3107 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 3107 launch in the OUS markets?
Speaker Change: And just kind of based on this potential delay in the U.S. BLA filing, could there be the first launch of 3107 OUS markets as early as late next year or early 2026?
Speaker Change: Again, 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. But I'll hand you over to Mike. Yeah, absolutely. So.
Mike Sumner: I see this pathway sort of similar to breakthrough therapy designation where you get increased access to the regulators to discuss.
Mike Sumner: 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.
Mike Sumner: We haven't 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.
Mike Sumner: We're very excited. It's a great honor, I think, for us. I mean, we were excited about Breakthrough Therapy designation. It's nice to have another regulatory body acknowledge the uniqueness and
Mike Sumner: how special our clinical data is to this patient population. So I think we just need to wait and give you...
Mike Sumner: A little more guidance on that at our next earnings call.
Mike Sumner: But we'll certainly look into what other drugs have received the same designation.
Mike Sumner: and let you know, but I don't think any...
Mike Sumner: drug to date has actually been approved under this pathway.
Mike Sumner: But we'll confirm that.
Speaker Change: And once again if you would like to ask a question simply press the star followed by the number one on your telephone keypad.
Speaker Change: Your next question comes from the line of Yi Chen with HC Wainwright. Please go ahead. Thank you for taking my questions. Just to confirm that
Speaker Change: Currently, you plan to initiate both the confirmatory trial and the re-dosing trial towards mid-2025, correct?
Speaker Change: So we have always said that the re-dosing study is going to be a post-approval.
Speaker Change: study.
Speaker Change: And the basis of that is, as you've seen from our Phase I-II study, we had very significant efficacy.
Speaker Change: 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.
Speaker Change: And so we always felt that it would be easier to achieve that study once we have the product approved and on the market, and there are a greater number of subjects that could actually be recruited into that study following receiving our primary series.
Speaker Change: Got it. So just confirmatory trial before the BOA submission.
Speaker Change: Is the redosing trial required for regulatory submission in Europe or UK?
Speaker Change: No, this is just our desire to further enhance our efficacy to
Speaker Change: In line with what the RRP Foundation want for their patients, a significant reduction in surgeries.
Speaker Change: And every surgery matters to those patients, so if we can enhance our efficacy.
Speaker Change: with further dosing, you know, beyond.
Speaker Change: We're already seeing 81% of patients respond.
Speaker Change: 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 Change: 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,
Speaker Change: understanding what are the immune responses that are driving that clinical benefit.
Speaker Change: So, as Mike says, you know, 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.
Mike Sumner: And also, you know, importantly for what is a chronic, potentially lifelong viral disease, make sure that we can maintain that production.
Speaker Change: Protection and Reduction for as long as is necessary. So I think it's, you know, it's an important part of the lifecycle management of 3107.
Speaker Change: 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 Change: We haven't really guided to that at this moment in time.
Speaker Change: Okay, thank you.
Speaker Change: And there are no further questions at this time. I would like to turn it back to Dr. Jackie Shea for closing remarks.
Jacqueline Shea: Thank you.
Speaker Change: I'd like to close today by reiterating that although we've met an unexpected challenge in our goal to submit our BLA for 3107 by the end of this year,
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: 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.
Speaker Change: Have a good evening, everyone.
Speaker Change: Thank you. And ladies and gentlemen, this concludes today's conference call. Thank you all for participating. You may now disconnect.
Speaker Change: Thanks for watching!
Speaker Change: You You