Inovio Pharmaceuticals - Earnings Call - Q2 2025

Executive Summary

• Q2 2025 execution de-risked the regulatory path: design verification (DV) testing for CELLECTRA 5PSP is complete, INOVIO requested a rolling BLA, and subsequently received FDA agreement with its rolling submission timeline; management targets full BLA submission in 2H25 and FDA file acceptance by year-end with potential mid-2026 approval if priority review is granted.
• Operating discipline continued: total OpEx fell 31% YoY to $23.1M; net loss narrowed to $23.5M ($0.61/share) vs $32.2M ($1.19/share) in Q2 2024; Q2 EPS matched consensus at ($0.61)*.
• Balance sheet: cash, cash equivalents and short-term investments were $47.5M at 6/30/25, excluding $22.5M net proceeds from a July equity offering; runway now extends into Q2 2026 with estimated Q3 2025 operational cash burn of ~$22M.
• Clinical/market momentum: INO-3107 durability data published in The Laryngoscope (Year 2 overall response 86% vs 72% at Year 1; CR 50% vs 28%) supporting BLA; confirmatory RRP trial to enroll ~100 patients across ~20 US sites.
• Near-term stock catalysts: FDA updates on rolling submission modules and BLA acceptance, confirmatory trial IND update/enrollment start, and continued commercial build (pricing/market access groundwork).

What Went Well and What Went Wrong

• What Went Well

  • Regulatory de-risking: “With device DV testing complete, we remain on track to submit our BLA for INO-3107 in the second half of this year, with the goal of having FDA acceptance of the file by year end.” — CEO Dr. Jacqueline Shea.
  • Strong durability data: Year 2 ORR improved to 86% (from 72% in Year 1); Year 2 CR rose to 50% (from 28%); mean surgeries fell from 4.1 pre-treatment to 1.7 (Year 1) to 0.9 (Year 2).
  • Cost control: OpEx down 31% YoY; CFO emphasized continued discipline to prioritize 3107 (“we've been able to significantly reduce our operating expenses”).

• What Went Wrong

  • No revenue base: Q2 revenue was $0 (vs $0.10M in Q2 2024), leaving results entirely expense-driven and dependent on financing.
  • Liquidity still finite: Cash fell to $47.5M at 6/30 before July raise; company still guides to ~$22M operational net cash burn for Q3, implying continued need to execute on pipeline/regulatory milestones to support financing optionality.
  • DV testing timing questions: Analysts flagged DV testing had been guided to complete in 1H; management said the overall BLA timeline remains on track but DV required coordination with multiple vendors.

Transcript

Speaker 8

Good afternoon, ladies and gentlemen, and welcome to the Inovio Pharmaceuticals Second Quarter 2025 Financial Results Conference call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Tuesday, August 12, 2025. I would now like to turn the conference over to Jennie Willson. Please go ahead.

Good afternoon, and thank you for joining the Inovio Second Quarter 2025 Financial Results Conference call. Joining me on today's call are Dr. Jacqueline Shea, President and Chief Executive Officer, Dr. Michael Sumner, Chief Medical Officer, Peter Kies, Chief Financial Officer, and Steve Egge, Chief Commercial Officer. Today's call will review our corporate and financial information for the quarter ended June 30, 2025, as well as provide a general business update. Following prepared remarks, we will conduct a question-and-answer session. During the call, we will be making forward-looking statements regarding future events and the future performance of the company. These events relate to our business plans to develop Inovio's DNA medicines platform, which include clinical and regulatory developments and timing of clinical data readouts 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. We refer you to the documents we file from time to time with the SEC, which, under the risk factors heading, 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 the link can be found on our website, ir.inovio.com, and a replay will be made available shortly after this call is concluded. I will now turn the call over to Inovio's President and CEO, Dr. Jacqueline Shea.

Speaker 6

Good afternoon, and thank you for joining today's call. I'd like to start today by highlighting the important progress we've made so far this year as we work to achieve our key strategic priorities. Most importantly, I'm very pleased to report that we remain on track to submit our BLA for INO-3107 in the second half of this year, thanks to several key accomplishments. We have completed the design verification, or DV testing, of our SelectRe5 PSP device, which allows us to move forward with the next key regulatory milestones for this program. Utilizing the Breakthrough Therapy designation awarded by the FDA to INO-3107, we have also requested rolling submission of our BLA. Our goal is to complete the submission and receive file acceptance by year end.

We plan to request a priority review of our BLA, which, if accepted, would provide us six months for review of the file, potentially providing for a PDUFA date around the middle of 2026. I'm also pleased to report that in addition to the publication of our Phase 1-2 clinical data in Nature Communications earlier this year, data from our retrospective study on the long-term clinical effect of INO-3107 have been published in The Laryngoscope, the leading journal for physicians who treat RRP. These data are an integral part of our BLA submission package and core to our belief that INO-3107 could become the preferred product for patients and providers alike. Mike and Steve will provide further detail shortly.

While we continue to drive progress on the regulatory front, we have also continued working to advance our commercial plans, ensuring that we are prepared for a swift and efficient launch should INO-3107 be approved. That includes engaging in further market research and continuing to refine our go-to-market plans. Finally, while we are primarily focused on the BLA submission for our lead asset INO-3107, we are excited about the potential of our broader pipeline. Most recently, we've had opportunities to highlight the broad therapeutic potential of our next-generation DNA medicine technology, including sharing the top-line data from a Phase 1-2 trial of our DNA-encoded monoclonal antibody, or DMAP technology, in a preprint on ResearchSquare, and featuring DMAPs and our DNA-encoded protein replacement, or DPOT technology, in a presentation at the Orphan Drug Summit in Boston this past July.

We believe there are multiple diseases or medical conditions that our DPOT platform could successfully target, and we are actively seeking partnerships to advance this technology into the clinic. I look forward to sharing more on our progress there in the coming months. With that, I'll turn it over to Mike for an update on our progress with INO-3107.

Speaker 2

Thanks, Jackie. As Jackie highlighted, we have made significant progress so far this year towards our primary goal, which is to submit our BLA for INO-3107 in the second half of 2025. With DV testing for the SelectRe5 PSP device complete and non-device-related modules of the BLA ready for submission, we have moved forward with the next phase of our regulatory plans, requesting rolling submission of our BLA from the FDA in July. Rolling submission is one of the options available to candidates like INO-3107 that have been granted Breakthrough Therapy designation. We aim to complete our BLA submission over the next several months and request a priority review. If granted, this would allow for a six-month review period leading to a potential PDUFA date in the middle of 2026.

We are now focused on finalizing the device-related sections of the BLA and updating our active IND so that we can commence enrollment for our placebo-controlled randomized confirmatory trial, which will include 100 RRP patients and be conducted at approximately 20 sites across the U.S. Amidst our focus on preparing for our BLA submission, I'm also pleased to report that the FDA inspection of Inovio Pharmaceuticals as clinical sponsor of the Phase 1-2 trial was successfully completed. This is an important step in the regulatory process that's designed to assess compliance with FDA regulations for the conduct of clinical trials. Finally, we've continued to add to the body of research demonstrating the transformational potential of INO-3107.

In addition to the immunology and clinical data from our Phase 1-2 trial published in Nature Communications earlier this year, data from our retrospective study, RRP 002, investigating the long-term clinical efficacy in patients treated with INO-3107, have just been published in a peer-reviewed journal, The Laryngoscope, which targets the key physicians who treat RRP. As a reminder, we conducted this separate retrospective trial to collect long-term efficacy data on 28 of the original 32 patients, with a median follow-up of 2.8 years. We first announced the data in December of last year and later presented it at the Combined Otolaryngology Spring Meeting, otherwise known as COSM. It demonstrates that INO-3107 provided significant clinical benefit to RRP patients, as measured by reduction in surgery, that continued to improve in almost all patients through year two and into year three following initial treatment.

More specifically, in the first year, 72% of patients saw a 50 to 100% reduction in the number of surgeries after starting treatment with INO-3107. With no additional dosing, this number increased to 86% in the second 12-month period or year two, with half of the patients requiring no surgeries at all, an increase from 28% in year one. Focusing on the mean number of surgeries per year, you can see here that they continue to drop from 4.1 surgeries in the year prior to receiving INO-3107 to 1.7 for year one to 0.9 for year two.

Although we only have partial data for year three, the improvement seems to be holding steady, and we believe this presents an opportunity to consider a longer-term treatment strategy that leverages one of the core strengths of our DNA medicine platform, which is the ability to administer additional doses to continue to drive and amplify strong T-cell-based immune responses without having to worry about the impact of an anti-vector response. With that approach, we could potentially maintain complete and partial responses or extend clinical improvement, including the potential for non-responders to mount a clinical response. Collectively, we believe this research illustrates some of the foundational strengths of our RRP program, strengths that potentially position INO-3107 as a new standard of care for recurrent respiratory papillomatosis and the preferred treatment by patients and their healthcare providers.

First, there is a significant unmet need for a therapeutic option that reduces the number of surgeries patients face to control this debilitating rare disease. Aside from posing risks for permanent vocal cord damage and burdening patients with emotional and financial costs, these surgeries don't address the underlying disease, and that's where the potential of INO-3107 comes in. Our treatment is designed to reduce the need for surgery for a broad range of patients by teaching their immune system to fight the human papillomavirus causing their disease. In the Nature Communications paper, we described our proposed mechanism of action, showing that INO-3107 was able to elicit an antigen-specific T-cell response against both HPV6 and HPV11 proteins, the two strains known to cause the vast majority of recurrent respiratory papillomatosis cases. That T-cell response correlated to the reduction in surgery we observed in the trial.

Looking at our RRP 001 and 002 clinical trials together, we have demonstrated that treatment with INO-3107 resulted in long-term surgery reduction for patients, indicating that INO-3107, if approved, could be an effective treatment option for recurrent respiratory papillomatosis (RRP) with the potential to change the trajectory of patients' disease. Finally, we are working to initiate the confirmatory trial, which is a randomized placebo-controlled trial that takes into account both FDA feedback and patients' focus on reduction in surgery and is designed for patients who have had two or more surgeries in the year prior to treatment initiation. The design of the trial also aligns with feedback from European regulators, which is important for future development plans. With that, I'll turn it over to our Chief Commercial Officer, Steve Egge, for some additional commercial insights. Steve?

Speaker 4

Thanks, Mike. I'd like to take a few moments to highlight how we're leveraging and building on those foundational strengths that Mike just described in our commercial strategy and why they're central to our belief that INO-3107 will become the preferred product for patients and providers. Let's start with the patients and the market opportunity. In the U.S., the most widely cited U.S. epidemiology data published in 1995 estimated there were 14,000 active adult and juvenile RRP cases and about 1.8 per 100,000 new cases of RRP in adults each year. However, research and our own claims data analysis indicate that these estimates are likely underrepresenting the prevalence of the disease. Because HPV vaccination rates are plateauing and because the majority of the adult population remains unvaccinated, the risk of RRP remains steady.

In fact, HPV experts believe the HPV vaccine is unlikely to have a significant impact on RRP prevalence in adults for at least a generation. As Mike noted earlier, INO-3107 was designed with the understanding that every surgery matters because every surgery carries both a risk and a cost to the patient. We believe INO-3107 has the potential to address a significant unmet need by targeting the underlying cause of RRP to reduce the number of surgeries these patients face. We also see potential to provide continuation of therapy with INO-3107, meaning additional dosing over time to maintain or extend patient outcomes, which is important in a chronic lifelong disease. Not only is there significant market opportunity here, our market research continues to tell us that patients and providers find the combination of efficacy, tolerability, and simplicity that INO-3107 offers very compelling.

With respect to efficacy, the vast majority of patients saw significant benefit from INO-3107, and for many of them, that benefit continued to improve over time. The physicians we spoke to were most interested in the overall response rate, 72% in year one, with an increase to 86% in year two. They noted, while the complete response rate is good, a 50% to 100% reduction in surgeries in eight out of ten patients is most compelling. Similarly, when laryngologists look at the tolerability data, they see a generally well-tolerated treatment that would have a limited impact on patients' return to daily life, which is important when a patient is receiving four doses over a relatively short period of time.

Finally, with respect to the treatment regimen itself, INO-3107 could be administered in the physician's office. There is no need to refer patients out to an infusion center, so the physician maintains control. The device is also simple to use, and with INO-3107, there is no requirement for scoping or surgeries during the treatment window. This is important because, again, every single surgery carries both a risk and a cost to the patient. These market insights have been critical as we continue to advance our launch preparations. Key progress so far includes building our distribution and channel strategy and identifying partners. We have signed a contract with a 3PL provider and are in the process of negotiating contracts with our specialty pharmacy, specialty distributor, and patient hub partners.

We have also conducted research with payers and developed our initial pricing strategy, as well as developed our physician and patient targeting segmentation and product positioning work supporting positive differentiation. I look forward to providing more updates on our progress next quarter as we finalize our go-to-market model and plan the further build-out of the commercial organization. With that, I'll turn it over to Peter for a financial update.

Speaker 5

Thanks, Steve. Today, I'd like to provide an overview of Inovio Pharmaceuticals' financial results for the second quarter 2025 and provide a financial snapshot of the year so far. Our goal is to ensure that Inovio Pharmaceuticals' resources are strategically aligned to advance our lead candidate, INO-3107. I am pleased to report that in the second quarter, we've continued to work efficiently and with fiscal responsibility to support the important progress my colleagues have highlighted today. As you can see here, we've been able to significantly reduce our operating expenses over the past year. Our operating expenses dropped from $33.3 million in the second quarter of 2024 to $23.1 million in the second quarter of 2025, a 31% decrease. When you look at the first six months of 2025, we've reduced operating expenses by 26% compared to the same period last year.

This is due to a strategic effort to manage our resources with the efficiency and precision needed to support progress for the INO-3107 program. Inovio Pharmaceuticals' net loss for the second quarter of 2025 dropped 27% to $23.5 million from a net loss of $32.2 million in the second quarter of 2024. On a per-share basis, both basic and dilutive, the net loss for the second quarter of 2025 dropped 49% to $0.61 per share from $1.19 per share for the second quarter of 2024. You can see similar reductions in our net loss for the entire six months of 2025 versus 2024 as we continue to conserve our resources to support the INO-3107 program. We finished the second quarter of 2025 with $47.5 million in cash, cash equivalents, and short-term investments compared to $94.1 million as of December 31, 2024.

This excludes efforts to strengthen our balance sheet with an underwritten public offering of common stock and warrants in July 2025. Net proceeds from the offering, after deducting underwriter discounts, commissions, and operating expenses, were approximately $22.5 million. Including the funds from the public offering, we estimate our cash runway to take us into the second quarter of 2026. This projection includes an operational net cash burn estimate of approximately $22 million for the third quarter of 2025. These cash runway projections do not include any further capital-raising activities that we may undertake. As a reminder, you can find our full financial statements in this afternoon's press release, as well as in our quarterly report, Form 10-Q, filed today with the SEC. With that, I'll turn it back over to Dr. Jacqueline Shea.

Speaker 6

Thanks, Peter. While we've spent most of today's call talking about our focus on INO-3107, we are very excited about the potential of our overall pipeline that continues to make progress through the power of our partnership. Of particular note, the ongoing exciting research at the Bassett Center at the University of Pennsylvania on the potential for INO-5401 to prevent cancer in people with BRCA1 and BRCA2 mutations has recently been highlighted in the news. While our partner, Apollo Bio in China, has continued to advance the Phase 3 development of VGX-3100 for HPV 16 and 18 related cervical H cell for that marketplace. As I mentioned earlier, we and our partners at the Wistar Institute and University of Pennsylvania announced top-line clinical data for our promising next-gen DMAP programs.

It's worth noting that our BLA for INO-3107 would be the first filed for DNA medicine in the U.S., and if approved, could open the door for future partnerships and development opportunities across our pipeline, both in the U.S. and globally. I'd now like to open up the call to answer any questions you might have. Operator?

Speaker 8

Thank you. Ladies and gentlemen, we'll now begin the question-and-answer session. Should you have a question, please press the star followed by the number one on your touch-tone phone. 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 two. If you are using a speaker phone, please lift a handset before pressing any keys. One moment, please, for your first question.

Speaker 9

Your first question is from Ted Tentoff from Piper Sandler. Please go ahead.

Speaker 3

Great. Thank you very much. Congrats on the update. Looking forward to continued progress, not just with the lead asset, but also the pipeline as you outlined. I'm wondering, as you start to wrap up the filing, are you anticipating having an advisory committee meeting? What kind of prep work are you doing for a potential advisory? Adco. Thanks.

Speaker 6

Hi, Ted. It's nice to hear from you. I'll hand over to Mike to talk about the advisory committee potential. Mike.

Speaker 2

Yes, thank you. Hi, Ted. Based on all our interactions with the agency today, there's certainly been zero indication that this will go to an adcom. When I look at the sort of overall risk-benefit of the data we're presenting, I don't think there will be any requirement for the agency, but obviously, that is their call. I think the chance of it is relatively low.

Speaker 3

Gotcha. In terms of preparation and anything going on, any thoughts in terms of the upcoming regulatory decision for your competitor and how that can either set the stage or potentially prime the pump for your eventual launch, hopefully next year? Thanks.

Speaker 6

Yeah, thanks, Ted. That's a good question. I think it's important to bear in mind that there are quite a lot of differences between their program and ours. For instance, the way they conducted their initial clinical study was very different. As you know, they conducted scoping and surgeries during their dosing window to maintain minimal residual disease, and we didn't do that. With our focus on every surgery matters for patients, we counted every surgery after day zero after we started dosing. Real differences in the way the trials were conducted. I think also real differences as well in the candidates. Our candidate, INO-3107, is based on DNA medicines technology. We don't have a viral vector involved. Very different technologies there. I think their vector, this will be the first time this particular vector has gone to a Biologics License Application filing. Differences there.

Finally, in terms of the confirmatory trial, we're going for very different confirmatory trial designs. We're going for a placebo-controlled design. We're aiming that trial at patients who've had two or more surgeries in the prior year. In contrast, they're going for a single-arm design. I think they're targeting patients who've had three or more surgeries in the prior year. Some real differences between the programs. Mike, Steve, anything you want to add to that?

Speaker 9

No, I think that was comprehensive, Jackie.

Speaker 3

Great. Thank you for the color.

Speaker 9

Your next question is from Jay Olson from Oppenheimer. Please go ahead.

Speaker 1

Oh, hey, this is Chen on the line for Jay. Thanks for taking the question and congrats on the progress. Just on the DV testing first, congrats on the completion of that. It just appears to us that maybe the prior guidance was to complete the DV testing in the first half. We're just wondering if there's any delays there or anything that may have changed regarding your interaction with the regulators. We have a follow-up question. Thanks.

Speaker 6

Yeah, I think that's a great question. I think the important thing to bear in mind is our overall timelines. We remain on track for submitting our BLA in the second half of this year with the goal of file acceptance by year end. The DV testing is quite a complicated process. We had to work with multiple external vendors, so that wasn't entirely within our control. I'm pleased to say we're now past that point. We're very much focused on the rolling submission of our BLA, and we're looking forward to those future milestones.

Speaker 1

Got it. Thanks, Chen, for the color. Again, congrats on the recent data on the long-term surgery reduction results from RPO2. I think there's still pretty good protection at year three. I'm just wondering your latest thinking around maybe a re-dosing strategy for INO-3107 based on the new data. Thank you.

Speaker 2

Yeah, no. I mean, we mentioned this partly in the call today. We are seeing a sort of stabilization of the clinical effect as we go into the third year. One of the benefits of our DNA medicine platform, and I think in the last call, we talked about data from our 3100 program that really shows that we can boost that cytotoxic T-cell response. We are definitely going to move forward with a re-dosing strategy, most likely something relatively simple, such as annual dosing, so that it's easy for patients and physicians to remember. Hopefully, that should enhance the clinical effect that we're already very excited about.

Speaker 6

Yeah, I think it's important to note that RRP can be a chronic, often lifelong disease. I think it's going to be really important that once patients are starting to see this clinical benefit of reduction of surgery, we're able to maintain that benefit and even potentially improve upon it. I think that's really a key strength of our technology.

Speaker 1

Got it. Just a quick follow-up on that. Is the re-dosing strategy going to be part of the filing, or do you need some additional data or evidence to show that? Thank you.

Speaker 2

We will start discussing that strategy with the agency after we've submitted our BLA.

Speaker 1

Okay, thanks so much.

Speaker 9

Your next question is from Sudan Loganathan from Stephens Inc. Please go ahead.

Speaker 1

Hi, Inovio team. Thank you for the update and congrats on your progress towards the filing for INO-3107. First, I wanted to ask, it was great to see the long-term year two data for INO-3107 get published. Can you remind me what the median number of prior surgeries these patients had that were enrolled in your trial?

Speaker 2

Certainly. Hi, Sudan. The patients in the original study had a median of four surgeries. You will see that we've presented mean surgeries in the latest long-term follow-up, and that mean was 4.1. When you look at the mean surgeries over time, that dropped to 1.7 in the original phase 1-2 12-month period, and then had a further reduction down to 0.9 in the year two, the second 12-month period year two.

Speaker 1

Got it. Great. I appreciate that. Secondly, with the potential approval by the end of this month for Prestigen's asset in recurrent respiratory papillomatosis, do you anticipate any headwinds to enrolling the 100 patients that you need for the confirmatory trial since there would be a potentially approved option on the market? Would you be open to including patients in your confirmatory trial that were previously dosed on Prestigen's 201-2 asset?

Speaker 2

Yeah, thank you. Obviously, I mean, Prestigen is not on the market at the moment, so it'd be a long time before those patients came into the trial. We have gone with a strategy that's included sites across the entire U.S. Even if Prestigen are approved, there is usually a lag between this coverage in the people's insurance policy. Also, unfortunately, there'll be many patients that still won't have the ability to be covered by medical insurance or be able to afford the out-of-pocket expenses. I still feel with the prevalence of this disease that we're seeing, there'll be a sizable population that will be still accessible for our clinical trial.

Speaker 6

I think it's also important to sort of remember that this trial isn't a particularly large trial. We're looking at recruiting about 100 patients across about 20 different clinical sites in the U.S. We think it's very achievable even if they are approved.

Speaker 9

Your next question is from Yi Chen from H.C. Wainwright. Please go ahead.

Speaker 1

Hi, this is Eduardo Han for Yi. I guess maybe to get some understanding on how diffuse these physicians are that treat these RRP patients and the commercial infrastructure you guys would need to execute and deploy in order to get a meaningful launch. You get some color there.

Speaker 9

Steve?

Speaker 4

Yeah, sure. I believe we've mentioned before, there's 300 to 400 laryngologists that we believe treat the majority of RRP patients out there. It's a mix of these large kind of academic medical centers. It's probably 65% to 70% of the patients seek care there. There's also large community-based practices, you know, laryngology practices that are treating these patients. The numbers overall are small. The patients are treated in a very kind of concentrated fashion. In terms of the commercial organization required to go after that, it's quite small. We haven't kind of guided to specific numbers there.

When you think about, you know, medical science liaisons, an access team, a sales team, it's a very small kind of cost-efficient commercial organization that's needed, you know, to get out and to promote to, you know, 300 to 400 laryngologists that live in a very narrow set of locations in the U.S.

Speaker 1

Got it. That's really helpful. Going back to the confirmatory trial design, one of the questions earlier mentioned the fact that you had 4.1 average prior surgeries in the initial trial, and now you're going to drop that down to, I understand it's around two prior surgeries in the prior year. Do you have any data from your initial trial with patients in that subgroup with the fewer surgeries that you could potentially extrapolate to understand the relative impact and reduction of surgeries that you anticipate for the confirmatory trial?

Speaker 2

Yeah, that was the mean number of surgeries. In the original trial, we actually had patients from two up to eight and actually had a very good spread of those surgeries across the entire population. We saw clinical benefit regardless of how we cut the number of surgeries pre-treatment. We're very confident that this will carry forward into our confirmatory trial.

Speaker 6

I think it's important to note that the reason why we're focused on patients who've had two or more surgeries in the prior year is it's really important to intervene early with RRP. Every surgery comes at a cost and risk to the patient. The sooner that we can come in with a non-surgical therapeutic alternative, the better chance we have of minimizing permanent damage to the vocal cords. We believe it's very important to start treating these patients as early as possible.

Speaker 1

Got it. Do you have an estimate in terms of what fraction of current RRP patients meet that clinical criteria?

Speaker 4

Sure. Yeah, this is Steve. The 14,000 that we referenced, the widely published data, we do think that's an underestimate, and we do believe that it's best to try to treat early in the disease to kind of change the direct trajectory of the disease. Every, like we said, every surgery matters. The 14,000 published data did not provide kind of a segment of patients, kind of how they break out in terms of surgical burden. I think what Mike just shared, in the phase one, phase two, we treated patients with a range of surgeries from two to eight with a median of four, and that may be representative of what the general kind of RRP population looks like. That's really the kind of prevalent population of patients. Keep in mind, there's also an incident population, newly diagnosed patients every year that also kind of adds to the opportunity.

As we mentioned earlier, we do expect there'll be an opportunity for continued treatment or additional doses over time, which also expands the commercial opportunity.

Speaker 1

Got it. That's really helpful. Thanks for taking the question. The next question is from Roy Buchanan from Citizens JMP. Please go ahead.

Speaker 0

Hey, Greg. Thanks for taking the questions. I wonder if you can provide maybe greater detail on the timelines for the next major events. More importantly, I guess which ones you're going to announce. I'm thinking FDA is okay for the rolling submission, the IND revision acceptance, start of the confirmatory trial, and BLA acceptance.

Speaker 6

Great questions, Royce. As we have said in the call, we requested rolling submission in July. We would expect to hear back from the FDA on that rolling submission sometime in August. Once we hear back, we have modules that are available to submit pretty much immediately. We're working on updating the device sections of our IND to enable enrollment to start within the confirmatory trial. We're aiming to complete the submission of all of our modules of the BLA in the second half of this year with sufficient time to allow us to receive acceptance of the file by the FDA by year end. That's the overall timeline. We're working as quickly as we can to try and get through those steps.

Speaker 0

Okay, great. Do you think you'll announce all of those publicly?

Speaker 6

Yeah, we're certainly committed to using our normal channels of communication to provide updates as they occur.

Speaker 0

Okay, perfect. Any interactions with the FDA since the last report? I guess any impact from some of the volatility around Dr. Prasad on those interactions?

Speaker 6

Yeah, we're very focused on the things that we can control, and our interactions with the FDA to date have continued as normal. We're just very focused on the work that we need to do to get our submission in.

Speaker 0

Okay, perfect. The last couple of ones, I noticed this publication from yesterday that full year three results were from 6 out of the 28 patients. Are you going to present data from the additional patients completing year three, maybe this year? One for Steve, any change to the pricing outlook from your prior comments? Thanks.

Speaker 2

Yeah, in terms of the data, we obviously have, because it was a single retrospective look, variable lengths of data depending on when they originally entered into the original study. We have provided some of the data in the press release. Because there is a different amount of data for different patients, it becomes more difficult to interpret. I think sort of digging into that third-year data just isn't the best sort of scientific approach, which is why the publication really focused on year two, where we have a complete set of data and we can present the complete picture of the original population.

Speaker 6

I think your second question about pricing. We previously guided to Ogsiveo as a potential analog there. We're not expecting any changes in our thoughts around pricing. We're expecting rare disease pricing. In discussions with payers, they seem to believe that this is appropriate. Really, no changes there. Steve, anything you want to add?

Speaker 4

No, with respect to price, I mean, we've commented there earlier. We did a fair amount of research with payers reviewing the product profile. As Jackie mentioned, rare disease pricing certainly is appropriate. The SpringWorks Therapeutics product Ogsiveo, that's priced at $360,000 a year. That's kind of the range of pricing that we're thinking and that we've shared with payers. Obviously, we can't give more specifics than that, but that's kind of the guidance that we've provided thus far.

Speaker 0

Perfect. Thank you.

Speaker 9

Your next question is from Lianne Grant from Jefferies. Please go ahead.

Speaker 7

Great. Thanks for taking our questions. This is Yi Chen for Roger. Maybe quickly touch on the confirmatory study. Understanding that the study has about 20 sites across the U.S., and also you have aligned your study plan with probably U.K. regulators. How should we think about your ex-U.S. strategy regarding the confirmatory study? Thank you.

Speaker 2

Yeah, I mean, we've mentioned we were very strategic in making sure that our confirmatory trial in the U.S. will meet the requirements of the European and UK regulators. We don't anticipate any difference in terms of how we would structure any study or design it. The two patients were fully in line with what we studied in our phase one-two study. As we've said, they've requested along with the FDA to have an inclusion criteria of two surgeries, you need to provide placebo-controlled data.

Speaker 7

Are there, for ex-U.S., any differences in the current practice of treating RRP?

Speaker 2

The one difference that I will note is obviously the majority of European surgeries are actually conducted in the operating theater. Because access to operating theater time in Europe can often be a little longer, they tend to actually have a slightly lower number of surgeries, which is again having the inclusion criteria of just two surgeries was actually important for our Europe to make sure that we could include as many European patients in the future onto INO-3107.

Speaker 7

Great. Thanks for the insights.

Speaker 8

Ladies and gentlemen, as a reminder, should you have any questions, please press the star key followed by the number one. We'll pause for further questions. There are no further questions at this time. Please proceed with closing remarks.

Speaker 6

Thank you. Before we close today, I'd like to take a moment to note that Inovio will continue the scientific and medical outreach strategy we outlined last quarter with a full schedule of presentation opportunities this fall. We'll be focused on continuing to illustrate the strengths of our RRP program and the potential of INO-3107, as well as the great potential we see for our next-generation DMAP and DPOT technologies. I'd also like to briefly mention the key catalysts we are focused on. First and foremost, submitting our BLA for INO-3107 on a rolling basis, updating our active IND for our confirmatory trial with our completed device data, and continuing to advance our commercial preparations so that we'll be ready to launch INO-3107 quickly and efficiently if approved.

Finally, I would like to emphasize what's at the heart of the progress I've outlined here today, the potential to change the treatment paradigm for RRP, a debilitating rare disease. We continue to be driven by the fact that every day and every surgery matters to RRP patients and to our mission. Thank you for your attention and good evening, everyone.

Speaker 8

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.