Inovio Pharmaceuticals (INO) Q4 2024 Earnings Call Transcript todayheadline

Inovio Pharmaceuticals (INO -1.42%)
Q4 2024 Earnings Call
Mar 18, 2025, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good afternoon, ladies and gentlemen, and welcome to the INOVIO Pharmaceuticals fourth quarter 2024 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. [Operator instructions] This call is being recorded on Tuesday, March 18, 2025.

And I would now like to turn the conference over to Ms. Jenny Wilson. Thank you. Please go ahead.

Jennie Wilson — Investor Relations

Good afternoon, and thank you for joining the INOVIO fourth quarter 2024 financial results conference call. Joining me on today’s call will be Dr. Jackie Shea, president and chief executive officer; Dr. Mike 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 and year ended December 31st, 2024, as well as provide a general business update. Following prepared remarks, we will conduct a question-and-answer segment. During the call, we will be making forward-looking statements regarding future events and the future performance of the company. These events relate to our business plans to develop INOVIO’s DNA medicines platform, which include clinical and regulatory developments and timing of clinical data readouts 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 heading Risk Factors, identify important factors that could cause actual results to differ materially from those expressed by the company verbally, as well as statements made within this afternoon’s press release. This call is being webcast live, and a link can be found on our website, ir.inovio.com, and a replay will be made available shortly after this call is concluded.

I will now turn the call over to INOVIO’s president and CEO, Dr. Jackie Shea.

Jackie Shea — President and Chief Executive Officer

Good afternoon, and thank you to everyone for joining today’s call. After significant progress in 2024, we remain focused on transforming INOVIO into a commercial-stage company and delivering on the promise of DNA medicines for patients and shareholders alike. To achieve that goal, our work this year will be driven by three main strategic priorities: submitting our BLA for INO-3107, a lead candidate for recurrent respiratory papillomatosis; advancing our commercial plan and preparing for a fast and efficient launch; and leveraging the strengths of our platform to drive progress across our diversified pipeline. Advancing 3107 is our primary focus, and I’m very pleased to report that we have resolved the previously announced manufacturing issues, involving the single-use array component of the CELLECTRA device.

Our next step is to perform the FDA-required device verification testing known as DV testing for the combined handset and single-use array required for our IND and BLA submission. We now plan to begin submitting our BLA on the FDA’s rolling submission process as well as commencing our confirmatory trial and requesting priority review in mid-2025. With this timeline, we anticipate being able to complete rolling submission in the second half of the year to enable the FDA to accept our BLA filing before the end of the year. Most importantly, we remain confident that if approved, 3107 could be the preferred non-surgical treatment for RRP for both patients and their physicians, a position that is strengthened by the Year 2 and Year 3 clinical data announced in December and the detailed immunology data we published in February.

Mike will provide more detail later in the call, but in our retrospective trial of 3107, patients showed continued improvement in reduction in surgery after Year 1 with 50% meeting criteria for complete response in the second 12-month period or Year 2, meaning they were surgery-free. Overall, the mean number of surgeries across the patient population continued to decrease into Year 3. The ongoing efficacy was observed — observed is also supported by the immunology data published in Nature Communications demonstrating the ability of 3107 to drive an anti-viral immune response in airway tissue that correlated with a reduced or eliminated need for surgery. We also have published the full safety and efficacy data set for the completed Phase 1/2 trial, which shows that the administration of 3107 was well tolerated.

In summary, 3107 offers significant and durable clinical benefits, tolerability and a simple patient-centric dosing regimen that does not require scoping or surgery during the dosing window, all of which we believe could be compelling advantages once on the market. While our immediate focus is on advancing 3107, I’m also pleased to provide an important update from our work on next-generation DNA medicines. Together with our partners, we recently announced top-line interim results from an ongoing Phase 1 trial with our DNA-Encoded Monoclonal Antibodies technology, which we call DMAbs. This proof-of-concept trial involves two DMAbs targeting SARS-CoV-2 and showed that they can be durably and simultaneously produced in humans at biologically relevant levels.

We believe this technology has the potential to overcome some of the biggest challenges with traditional recombinant monoclonal antibodies and could also transform treatment for broad range of diseases by enabling long-term in-vivo production of therapeutic antibodies or other proteins. Now, I’ll turn it over to Mike for some additional insights on our progress and new data on 3107. Mike?

Mike Sumner — Chief Medical Officer and RRP Program Lead

Thank you, Jackie. As Jackie mentioned, we have made tremendous progress toward our primary goal, submitting our BLA for 3107. We have now completed the drafting of all non-device modules, including non-clinical, clinical, and CMC modules. And after extensive testing and internal quality sign-off, we have resolved the previously announced manufacturing issue involving the single-use array component of the CELLECTRA device.

To resolve the issue, our device team strengthened key components, reduced stress on breakage areas, and refined the production process for the plastic molded part of the array. We have tested the new array under similar testing to conditions to when the issue was first identified and have not been able to reproduce the breakage, which gives us great confidence that the modifications have resolved the issue. We began manufacturing our new commercial-grade arrays, which will now be utilized in the design verification testing, so we can move forward to completing our IND and BLA submissions. In addition, the full Phase 1/2 clinical data and accompanying detailed immunology data were recently published in Nature Communications.

These data further support the T-cell mechanism of action for 3107, which underpins the efficacy results we’ve seen. We also announced some very exciting clinical durability data, showing that patients treated with 3107 continue to show further reduction in the need for surgery to manage their disease in the second and third year. This data will be the subject of an oral presentation at the Combined Otolaryngology Spring Meeting to be held in New Orleans this May, one of the most frequented meetings by our target physicians treating RRP. We’ve also made important progress in preparing for our Phase 3 confirmatory trial.

As a reminder, this will be a randomized placebo-controlled trial enrolling patients with two or more surgeries in the prior year conducted at approximately 20 sites at major U.S. medical centers. This progress to date will enable us to enroll in a timely manner following submission of our updated IND. I’d like to spend some time now discussing the new data, as it paints a compelling product profile that strengthens our belief that 3107 could be the preferred product for RRP patients and their physicians.

As a reminder, we completed a Phase 1/2 open-label trial of 3107 in patients who required at least two surgeries in the previous year for the removal of HPV-6 and 11-related papillomas. It’s important to note that based on our understanding of the risk and cost to the patient of every single surgery, every surgery performed after day zero was counted against the efficacy endpoint in our trial where we followed the patients for 12 months. We then conducted RRP-002, a retrospective trial in which we were able to collect data on 28 of the original 32 patients to assess the longer-term treatment effect with a median follow-up of 2.8 years. RRP is a chronic often lifelong disease, and duration of efficacy is clearly important.

Here, we dive into the 002 data, looking at the longer-term efficacy results we observed in the trial. We were very pleased to see that patients continue to show improvement into years two and three following their initial dosing regimen. In fact, the complete response rate increased to 50% for the second 12-month period when evaluated at the end of Year 2. We also saw the overall response rate, that is the number of patients that had 50% to 100% fewer surgeries compared to their pretreatment baseline increased from 72% in the first 12-month treatment period or Year 1 to 86% for the second 12-month period or Year 2.

When you look at this in terms of the average or mean number of surgeries this patient group faced, it reduced by more than half from a mean of 4.1 surgeries per year prior to treatment to a mean of 1.7 surgeries at the end of Year 1 and then reduced further by the end of Year 2 to a mean of 0.9 surgeries. Across the population of patients treated with 3107, this is a reduction of greater than 75% following the initial treatment regimen alone. However, one of the core strengths of our DNA medicines platform is the ability to administer additional doses to continue to drive an amplify strong T-cell-based immune responses, without having to worry about the impact of an anti-vector response. Looking again at the mean surgeries per year across the population, we saw a significant decrease in the year following treatment and then a further decrease in the second 12-month period or Year 2.

Into Year 3, the improvement seems to be holding steady. And what we would like to be able to do is consider a longer-term treatment strategy that supports both the maintenance of that complete or partial response and potentially extending clinical improvement, including the potential for non-responders to mount a clinical response. We have published data from a similar DNA medicine that targeted the E6 and E7 antigens of HPV-16 and 18 that demonstrated we were able to augment the CD8 T-cell responses with a single additional dose, given after completion of the primary treatment course when compared to pre-dose levels. This further increase in cytotoxic T-cells supports the potential of extending the duration and improving upon the already excellent clinical response that we have seen to date.

Every surgery matters to patients, and our vision for INO-3107 is to further minimize or eliminate future surgeries for all RRP patients. As I said earlier, the immunology data we’ve recently published becomes important here as it underpins the mechanism of action of 3107 and how we believe treatment is providing the favorable efficacy results we observed. First, in our analysis, we found that all the patients were generating the right kind of anti-viral immune responses to fight HPV, specifically antigen-specific cytotoxic T-cells. And then we saw that these T-cells really got where they needed to go, traveling from the blood into the airway and papilloma tissue.

Once they were in the airway tissues, they created an antiviral immune response, which we believe is responsible for reducing or eliminating the need for surgery by eradicating HPV-infected cells. I would also like to note that while other investigators have suggested that multiple factors such as high viral loads or neutrophil infiltration in the papilloma microenvironment can be barriers to immunotherapy treatment of RRP. We didn’t see any such factors impacting the efficacy we observed in the trial. While all patients were generating the right kind of immune response, in our non-responders, this response wasn’t as large and tended to decrease faster than in our responders, which again is why we believe continued treatment may improve clinical outcomes in these patients.

Overall, our immunology data provide a clear demonstration of the mechanism of action behind INO-3107, showing that it is doing exactly what is needed to treat the underlying HPV infection that causes RRP. To wrap up, I want to provide some additional detail on our next steps for 3107. Now that we have resolved the array issue, we have commenced the manufacturing of the new arrays, which we will subsequently age-condition and utilize in the conduct of the FDA-required design verification or DV testing process, which we anticipate will be completed in the first half of this year. This testing is required to update the IND before we can dose patients in our confirmatory trial and is also part of the last remaining module of our BLA package we need to complete.

We plan to request rolling submission and priority review of our BLA. And if FDA agrees, we will begin submitting our modules in mid-2025 and complete the full submission three to four months later with the goal of having the FDA accept our complete BLA for filing by the end of the year. Once the entire BLA is submitted, we plan to finalize our long-term dosing study strategy and submit a proposed protocol to the FDA to support a supplemental BLA in the future. We also look forward to commencing onboarding of our field medical science liaison team and presenting this exciting data package at several upcoming conferences this spring, including the U.S.-based National HPV Conference, the European ALS Congress, and COSM, among others listed on the slide.

With that, I will now turn it over to our chief commercial officer, Steve Egge, for an update on our commercial efforts. Steve?

Steve Egge — Chief Commercial Officer

Thanks, Mike. I’d like to build on the 3107 data Mike shared by reviewing why our work on RRP is so important, what the market looks like, why 3107 could be the product of choice for patients and providers, and what we’re doing to prepare for potential commercialization. For those new to our work, RRP is a rare HPV-related disease that affects around 14,000 people in the U.S. It’s characterized by work-like growth called papilloma to grow in the respiratory tract and can cause difficulty speaking, swallowing, and breathing and repeated surgery is the standard of care today.

Every one of these surgeries matters to patients because every surgery poses a risk of irreversible damage to the vocal cords and carries costs, including the financial expense, but more importantly, the significant time and stress of preparing for and recovering from each surgery. Patients and their providers want a non-surgical option for RRP that addresses the underlying disease and that ultimately helps them avoid additional surgeries. We designed 3107 with the patient experience in mind, and we believe it has the potential to become the preferred treatment option for RRP based on the efficacy and tolerability results we’ve observed to date, as well as the simple patient-centric treatment regimen. As Mike discussed, not only do we observe favorable efficacy results in patients treated with 3107, we saw continued improvement into the second 12-month period or Year 2 for both complete and overall response rates.

3107 was well tolerated in the trial and there were no discontinuation. And finally, 3107 offers a simple patient-centric treatment regimen that does not require additional potentially unnecessary scoping and procedures during the treatment window. And finally, 3107 offers office-based administration without the need for referral, a preference that many physicians shared with us in market research. We’ve shared a few other insights on this slide from that research reinforcing our belief in the strength of 3107’s product profile.

One laryngologist told us the complete response rate of 50% is good, but a 50% to 100% reduction in surgeries in eight out of 10 patients is the most compelling. When laryngologists review our data, they quickly move to think about how they would describe the product to their patients. And they indicate they like being able to say the vast majority of patients see significant benefit from treatment. Likewise, both the tolerability profile and simple patient-focused treatment regimen were very well received by laryngologists, who are currently treating RRP patients.

Moving on, I’d like to share just a few updates on our commercial launch preparations. Since last quarter, we’ve made significant progress, including developing our distribution channel strategy and identifying channel partners, developing our initial pricing strategy, and completing targeting, segmentation, and product positioning work to establish positive differentiation. We’re currently developing our go-to-market model and planning a further build-out of the commercial organization. Given the RRP market is highly concentrated with the majority of RRP patients treated by relatively few laryngologists, we believe we will need a small and efficient field force footprint.

There’s still a lot of work ahead, but I’m energized by what we’ve built so far and look forward to providing an update on our progress next quarter. With that, I will turn it back to Jackie.

Jackie Shea — President and Chief Executive Officer

Thanks, Steve. While 3107 is at the forefront of our work, we are excited about the opportunities to leverage the strengths of our platform across the pipeline, including what we see as the next generation of DNA medicine technology. Harnessing the power of in vivo protein production and enabling the body to generate its own disease-fighting tools is a key strength of our DNA medicine platform and our DMAb technology leverages that strength in another way. Using our proprietary gene sequence optimization technology, we can create precisely designed DNA plasmids that encode for specific monoclonal antibodies.

These plasmids, also called the DNA, can then be delivered directly into muscle cells in the arm using our CELLECTRA delivery system. The heavy and light chain proteins that make up the DMAbs are produced and then assembled into functional antibodies within the muscle cells and are then secreted into the blood where they can circulate within the body. This contrasts with conventional monoclonal antibodies, which are manufactured in in-vitro systems and then need to be administered through regular infusion or injection. We recently announced top-line interim clinical data from an ongoing Phase 1 proof-of-concept trial evaluating DMAbs for COVID-19, led by Wistar Institute in collaboration with AstraZeneca, the University of Pennsylvania, and INOVIO and funded by DARPA and JPEO, this trial has provided the first clinical proof-of-concept that DMAbs can be durably and simultaneously produced inside the human body.

Specifically, we saw long-lasting in-vivo antibody production with DMAb levels remaining stable for 72 weeks in all participants who have reached that time point. No anti-drug antibodies or immune rejection of the DMAb was detected across approximately 1,000 blood samples, unlike other gene-based antibody delivery approaches. And treatment was well tolerated with the most common side effects being mild temporary injection site reactions such as pain and redness and no serious adverse events related to study drug. And we saw that the express DMAbs successfully balanced the SARS CoV-2 spike protein receptor-binding domain confirming functional activity through week 72.

I also just want to point out that the panel on the right-hand side of the slide shows the representative data from one dose-level cohort from the trial. The consortium plans to present its important clinical data in the first half of the year at various scientific conferences and has submitted a manuscript to a leading peer-review journal, which is currently available in preprint on Research Square. We believe this technology could have the potential to be a breakthrough that could overcome many of the challenges seen with traditional monoclonal antibody production. With rapid manufacturing, low cost of production, stable temperature storage, and distribution, and the ability to redose, DMAb technology could help expand use, reduce cost, and enable access in low-resource settings.

Importantly, unlike other delivery platforms, our DNA-based approach has demonstrated sustained antibody production without generating anti-drug antibodies, making it a potentially promising long-term solution for conditions requiring continuous therapeutic protein delivery. We see broad potential for this technology and we and our partners at Wistar have been investigating the feasibility of DMAb across multiple disease targets, mostly in a preclinical setting from flu to HIV to cancers and to the most recent clinical trial targeting COVID-19. I believe this is an excellent example of how we’ve been able to work through partnerships with non-dilutive funding to advance our DNA medicines platform. We look forward to continuing working with our partners to complete the current Phase 1 trial and on future research where we plan to explore a number of these broader applications of our technology for long-term therapeutic protein delivery.

Moving on to the rest of our pipeline. You’ll see here that we have two other novel technologies in the preclinical stage, DNA launch nanoparticle or DLNP candidates addressing infectious diseases. And following on from my comments on DMAb, DNA encoded protein replacement candidates or DPROT, addressing various disease targets where disease is caused by missing or defective protein. These fall into that next-generation category of our technology, and we’re very excited about what the future holds for these novel approaches.

With regards to our later-stage pipeline, we’re leveraging the opportunity to build on our extensive experience in HPV-related diseases and advancing plans for a Phase 3 trial to evaluate INO- 3112 in combination with the FDA-approved PD-1 inhibitor LOQTORZI, as a treatment for locoregionally advance, high-risk HPV-16 and 18 positive throat cancer. With the trial planned across both North America and Europe, we’ve discussed the trial design with FDA and most recently received some initial feedback from the European regulators on the trial design. We believe our current sign will be sufficient to address those comments and our next steps include finalizing the trial protocol and completing manufacture of the candidate. We’re also advancing discussions on the design for a Phase 2 trial of INO-5401 in newly diagnosed glioblastoma and we look forward to advancing this and other promising candidates through collaboration and other potential strategic opportunities.

I will now turn it over to our chief financial officer, Peter Kies, for a financial update. Peter?

Peter D. Kies — Chief Financial Officer

Thanks, Jackie. Today, I’d like to provide an overview of INOVIO’s financial results for the fourth quarter and full year of 2024. As Jackie noted at the start of our call, our primary goal is advancing INO-3107, being ready to begin the submission of our BLA in mid-2025, and ensuring that we have the resources to support this critical work. To that effect, we raised more than $72 million in gross proceeds from two equity offerings in April and December of 2024 and from equity sales from our ATM.

We also continue to decrease operational spending with our total operating expenses dropping from $27.5 million in fourth quarter of 2023 to $20.5 million in the fourth quarter of 2025. Our full-year operational expenses decreased 22% from $144.8 million in 2023 to $112.6 million in 2024. INOVIO’s net loss for the fourth quarter of 2024 was $19.4 million or $0.65 per share basic and dilutive, and our total net loss for the full year of 2024 was $107.3 million or $3.95 per share basic and dilutive. We finished the fourth quarter of 2024 with $94.1 million in cash, cash equivalents, and short-term investments compared to $145.3 million, as of December 31, 2023.

We estimate our cash runway to take us into the first quarter of 2026. This projection includes an operational net cash burn estimate of approximately $27 million for the first quarter of 2025. Historically, our first quarter operational net cash burn runs higher than other quarters. These cash projections — these cash runway projections do not include any further capital raise activity that INOVIO may undertake.

As a result, you can find our full financial statements in this afternoon’s press release as well as in our Form 10-K filed with the SEC. And with that, I’ll turn it back over to Jackie.

Jackie Shea — President and Chief Executive Officer

Thanks, Peter. I’d now like to open up the call to answer any questions you might have. Operator?

Questions & Answers:

Operator

Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. [Operator instructions] One moment, please, for your first question. Thank you.

And your first question comes from the line of Roy Buchanan from Citizens. Please go ahead.

Roy Buchanan — Analyst

Hey. Thanks for taking the questions. Glad to hear you’re on track with 3107. Had some, I guess, some details, let’s start with 3107.

So, the BLA submission request, do you need to meet with the FDA, or do you just request that in writing? And if you need to meet, have you requested that meeting?

Jackie Shea — President and Chief Executive Officer

Yeah. Good question, Roy. Mike, do you want to take that?

Mike Sumner — Chief Medical Officer and RRP Program Lead

Yeah, happily. So, we actually held a pre-BLA meeting with the FDA prior to the single-use array breakage that we found and have now resolved. And at that time, we actually had very good alignment with all the remaining modules. And so, we — as soon as we complete the device modules, our BLA will be complete.

And as we talked about today, we plan to hopefully start rolling submission in the middle of next — of this year, as all the other remaining modules are complete.

Roy Buchanan — Analyst

OK. Great. Just —

Jackie Shea — President and Chief Executive Officer

A request, yeah, we don’t need to have another meeting.

Mike Sumner — Chief Medical Officer and RRP Program Lead

No more meeting, but we do need to request the rolling submission.

Roy Buchanan — Analyst

Yeah. Got it. OK. And then — so for the stability test, is that — maybe you said — sorry, I missed it, but is that a single test, or do you need to repeat a whole battery of tests? And are you doing that yourself or is it a third party? Who conducts the test?

Jackie Shea — President and Chief Executive Officer

Yeah. That’s a great question, Roy. So, we need to repeat a number of the tests required for device verification or DV testing where we’re testing the array in combination with the handset. So, we need to repeat a number of those different tests.

And we use an external testing house to do that. So, we’ve previously worked extensively with the testing house. They’re great partners, but we do need to do that externally. And there’s also some external certification that’s required as part of this process that goes into our BLA as well.

Mike, anything to add there?

Mike Sumner — Chief Medical Officer and RRP Program Lead

No. I think you’ve covered all the major points.

Roy Buchanan — Analyst

OK. Great. And then maybe on the DMAb, I thought the data in the publication is pretty compelling, clearly differentiated from mRNA even self-amplifying RNAs in terms of durability. But I didn’t see anything in the publication about half life.

Seems like it’s clearly longer than even the extended half-life antibodies that you’re expressing. Do you have any sense of what the half-life from the DNA constructs themselves might be in people?

Jackie Shea — President and Chief Executive Officer

Yeah. I’m not sure if we’ve released all of that data yet, Roy, as part of the publication. What we do have in the publication is some details of some modifications we’ve made for these particular monoclonals to extend half-life. So, happy to follow up with you after the call on the specific details of those.

Roy Buchanan — Analyst

OK. Great. And then, Jackie, I know you mentioned some other wide range of potential applications for the technology and the publication mentions GLP-1, for example. Do you have any — anything you can disclose today about potential programs over the next 24 months or so? Thanks.

Jackie Shea — President and Chief Executive Officer

Yeah. I think first of all, I would say we were really excited to see that the level of functional antibody production that we saw over such a long time period and the fact that we didn’t see any anti-drug antibodies at all coming up. So, we were really excited about that. On today’s call, we shared with you a broad range of other targets that we previously worked on and are working on, and we hope to provide further updates on those targets in due course.

But we’re really excited by the power of this technology and the level that we’re producing these antibodies at the moment is biologically relevant and spans the levels needed for a wide range of targets. So, we’re really excited by this.

Roy Buchanan — Analyst

Yeah. OK. Sounds good. Thank you.

Jackie Shea — President and Chief Executive Officer

Thanks, Roy.

Operator

Thank you. And your next question comes from the line of Jay Olson from Oppenheimer. Please go ahead.

Jay Olson — Analyst

Hey, congrats on resolving the manufacturing issues with the CELLECTRA device, and thank you for providing this update. We had a question about the timeline for testing and validation of the new manufacturing process and how long it takes for validation before including the new manufacturing information in your filing package.

Jackie Shea — President and Chief Executive Officer

Yeah. Sure, Jay. So, first of all, I’m just really thrilled and delighted that we fixed the snap frame part, the single-use array component of the device that broke. The process did take a little longer than we initially expected as we needed to make some design changes to the part, which also required us to improve the actual molding process.

Now that we’ve got this behind us, we started manufacturing new arrays and we plan to start device verification testing very soon. And we anticipate we’re going to complete all of that in the first half of this year. As Mike said earlier on in the call, once this process is near completion, we’ll reach out to the FDA and request rolling submission of the BLA. Since we have all of the other modules completed and ready for submission.

And then once that’s granted, we expect to begin submitting the modules in mid-year and anticipate being able to complete the submission three to four months later with the expectation that FDA will accept full BLA for review prior to the end of the year.

Jay Olson — Analyst

OK. Great. Thank you so much for that detailed explanation. And maybe just one follow-up question.

Do you need to initiate the confirmatory study before the BLA submission?

Jackie Shea — President and Chief Executive Officer

So, we do need to initiate the confirmatory trial before the BLA submission, but we’ve made really good progress in terms of doing that. And Mike, do you want to jump in here?

Mike Sumner — Chief Medical Officer and RRP Program Lead

Yeah, absolutely. So, I mean, we’ve previously talked that we have identified the majority of the sites. We’ve actually advanced contracts and actually have IRB approvals at several sites. So, the whole reason the FDA usually asks you to commence that trial is so that they can feel confident that you are going to meet the commitment to complete the study.

We’ll be very easily able to demonstrate to the FDA the seriousness we’re approaching the study and the fact that we want to complete enrollment and the study as quickly as possible.

Jay Olson — Analyst

Great. That’s fantastic news. Thanks again for taking the questions, and congrats on all the progress.

Jackie Shea — President and Chief Executive Officer

Thanks, Jay.

Operator

Thank you. And your next question comes from the line of Sudan Loganathan from Stephens. Please go ahead.

Sudan Loganathan — Analyst

Hi. Good afternoon, and thank you for giving this update, and congrats again on the great progress here with this CELLECTRA device and resolving those issues. My question is on that topic. Just curious to hear your take on, aside from the initiation of the confirmatory trial needed to submit for the BLA, is there anything else holding you back from just starting to submit the non-device component modules, of the BLA now and starting the rolling process that way versus waiting a few more months to start submitting everything?

Jackie Shea — President and Chief Executive Officer

Yeah. That’s a really good question, Sudan. So, we have — as we said, we have all of the other modules ready to go. FDA normally once you’ve started rolling submission, FDA normally like you to submit all of your modules in a three- to four-month timeframe.

But it is a discussion that we can have with the FDA as to when we can start rolling submission. And I think the important thing is that we start our DV testing, have made good progress on the DV testing before we set that end timeline, for when we’re going to deliver all of the modules to the BLA. So, I think the guidance that we’re providing at the moment is that we’re going to start rolling submission mid-year, and we expect to complete that within three to four months. But obviously, we’re going to try and accelerate things as much as possible.

Every day matters to our RRP patients, and we’re very conscious of that.

Sudan Loganathan — Analyst

Got it. No, thank you for that. And quickly, just to hopefully jog my memory better, was the DV testing where the initial, the breakage of the CELLECTRA device component was discovered previously, or did — yeah, were you able to get to the DV testing point, last time, before?

Jackie Shea — President and Chief Executive Officer

Yeah. I mean, last time we were pretty far through our DV testing when I believe we identified the issue with the single-use array. Mike, do you want to add any detail there?

Mike Sumner — Chief Medical Officer and RRP Program Lead

Yeah. So, I mean, we identified the issue following the age conditioning. And we have actually, with the — as part of the progress that we made and how we develop this. We actually have already aged some of the arrays in similar manner and actually performed the testing.

So, we really are confident that we will — we’ve resolved the issue. We do, however, have to actually repeat the formal aging and the formal testing once we have actually signed off the fix, which we have done and we’ve started manufacturing those sort of commercial grade arrays. But we do not expect to see any issues going forward with the array.

Sudan Loganathan — Analyst

Got it. Thank you. And just really quick one last one. Just given the context for the RRP patients often require multiple surgeries per year and the substantial healthcare costs and risks associated with that, as you know.

Has there been any health economist or payer research conducted yet, on the potential pricing or the advantages of therapeutics such as 3107 that would in savings, for the healthcare, providers and/or the healthcare facilities and the system in general? Or is that something that could come maybe after approval, once we kind of get a better idea of pricing? Just kind of curious what — if that’s — anything has been done on your end on that.

Jackie Shea — President and Chief Executive Officer

Yeah. Steve, do you want to take that one?

Steve Egge — Chief Commercial Officer

Yeah. Sure. So, thanks for the question. So, we’ve done a fair amount of research with payers where we reviewed product profile, reviewed budget impact models, and talked to them about kind of price ranges.

This is rare disease. We do expect rare disease pricing. So, kind of what we’ve shared is that could be a pretty big range, anywhere from $200,000 to $2 million a year. But one analogy that we look at that’s pretty close, like, we’ve referenced it before, the OGSIVEO from SpringWorks Therapeutics.

It’s a product for desmoid tumors, kind of the first medical therapy. The standard-of-care kind of prior to that launching was repeated surgeries. They’re in the price range of $360,000 per year, that’s kind of a price that we referenced. And the feedback that we’ve gotten from payers is that that kind of rare disease pricing range is very acceptable to them.

So, we don’t expect any issues, kind of with rare disease pricing, if that helps.

Sudan Loganathan — Analyst

Yeah. That’s great. Thank you. Thank you again for all the answers here and congrats again on all the progress and looking forward to the progress going forward.

Jackie Shea — President and Chief Executive Officer

Thank you.

Operator

Thank you. And your next question comes from the line of Yi Chen from H.C. Wainwright. Please go ahead.

Yi Chen — H.C. Wainwright and Company — Analyst

Hi. Thank you for taking my questions. Regarding the utility of the DMAb technology, particularly in terms of the Phase 1 proof-of-concept trial evaluating DMAb causing COVID-19, could you tell us how durable is the in-vivo antibody production? And in future clinical trials, in case the produced antibody has some undesirable effects, is there a way that you can turn off the antibody production? Thank you.

Jackie Shea — President and Chief Executive Officer

Yeah. Hi, Yi. Those are both great questions. So, in terms of how durable the antibody production is, I mean, as I think you saw, on the slide, we presented and if you take a look at the preprint as well, we’re now out for 72 weeks, and we’re not seeing any drop in terms of the levels that we’re seeing secreted into the serum.

So, our production seems to be holding up over 72 weeks. So, we think that’s really excellent durability. And then in terms of future clinical trials, I mean, we’re excited by what this technology could mean across a wide range of targets. There are either inducible or repressible promoters that you could use to turn off the genes or turn on the genes to be able to control expression.

But I think initially, we’ll be focused on targets that were already in the right therapeutic range and where there’s less concern about potentially turning off those antibodies. So, I think those will be the targets that we focus on initially.

Yi Chen — H.C. Wainwright and Company — Analyst

And in terms of the location of the antibody production, is it primarily produced in certain parts of the body, or it’s produced throughout the body?

Jackie Shea — President and Chief Executive Officer

Yeah. Again, great question. So, we’re administering our DMAbs into the deltoid muscle in the arm. And the DMAbs are actually produced within the myocytes within the muscle cells.

They’re produced as heavy and light chain proteins, which then are self-assembled and then are secreted into the bloodstream from the myocytes. So, it’s actually production in these muscle cells, which are pretty long-lived cells, the myocytes.

Yi Chen — H.C. Wainwright and Company — Analyst

OK. Got it. Thank you.

Operator

Thank you. And your next question comes from the line of Gregory Renza from RBC Capital Markets. Please go ahead.

Anish Nikhanj — Analyst

Hi, guys. It’s Anish on for Greg. Congrats on the progress this quarter and thanks for taking our questions. Just a couple from us.

As you think about taking 3107 commercial, in the future potentially, what are your going assumption for labeling? And what particular points would you like to see that could play to the strengths of your program both on its own merits and even over competitors? Thanks so much.

Jackie Shea — President and Chief Executive Officer

Yeah. Great questions, Anish. I mean, first and foremost, I think we’re really, really confident in the very strong product profile that we’re seeing with INO-3107 with — we’ve observed great and durable efficacy. The treatment’s been very tolerable.

And then it’s, we’ve designed, really, 3107 with the patients in mind. So, we have a very patient-centric treatment regimen. We don’t require any scoping or any surgery during the dosing window. We’re able to administer the treatment in the doctor’s office, so there’s no need for them to go to, for instance, to an infusion center to receive the product.

So, we think that product profile is really, really compelling. I think, obviously, we’re still very close to filing our BLA. And so, I think we can’t really comment at the moment about the potential label implications. But I think the phase that we’ve generated in this patient population who previously had two or more surgeries is, it’s really compelling.

Mike, anything you want to add there?

Mike Sumner — Chief Medical Officer and RRP Program Lead

Yeah. I mean, I — when you have these discussions with the agency, your label is always a negotiation. But ultimately, it is about sharing the risk-benefit ratio for the physician and for the patient. And I think as you heard today, I mean, we’re able to now really demonstrate the durable clinical effect of INO-3107.

And I would hope we’ll be able to discuss that with the agency and get that taken into account because RRP is not a disease that’s defined by a 12-month period. It’s a chronic viral infection, and these patients have multiple surgeries. So, I think it’ll be an interesting discussion that we’ll have with the agency in the future.

Anish Nikhanj — Analyst

Great. Thank you so much.

Operator

Thank you. And your next question comes from the line of Roger Song from Jefferies. Please go ahead.

Liang Cheng — Jefferies — Analyst

Hey, team. Thank you for taking our question. This is Liang Cheng for Roger. So, I guess two questions from us regarding RRP and the 3107.

First one, really great to see the durability data of the 3107 up to two years, three years. So, just wondering how should we think about the redosing commercially, if you think about the durability and increased response there. And second, as we think about the treatment of RRP disease, so how should we think about, in a longer term the epidemiology and addressable market there? Thank you.

Jackie Shea — President and Chief Executive Officer

Thanks. I caught your first question about the redosing strategy. I’m sorry, I didn’t quite catch your second question. Could you repeat that?

Liang Cheng — Jefferies — Analyst

Yes. So, as we have — now have those 3107 and those treatment — new treatment for RRP, do we expect lower epidemiology like decreasing epidemiology over time? And how should we think about the addressable market there?

Jackie Shea — President and Chief Executive Officer

Yeah. Great question. OK. Mike, do you want to take the readout? And then I’ll take the EPI question.

Mike Sumner — Chief Medical Officer and RRP Program Lead

Yeah, absolutely. So, I mean, as we said in today’s call, we’re actually still deciding on the redosing strategy. I think as we looked to our sort of excellent efficacy, it did make us think about how we could design the clinical trial to get a future labeling change. I think we’re also sort of in the position now that we started off this process looking at it very much from a sort of regulatory lens of complete remission, partial remission, etc.

But really that isn’t how the physicians look at this. They look at this at a totality of the surgeries that these patients have. And so, we want to, as we think about this strategy, see what — see how we can reduce the surgeries to hopefully zero, and how we can maintain that excellent clinical response that we’ve seen. So, I mean, hopefully, we’ll have some more details in upcoming calls.

But at the moment, we really are still thinking about how best to accomplish the goals, knowing exactly what our platform is capable of doing with the redosing and being able to boost that CDA response that we’ve seen with 3107 in the past.

Jackie Shea — President and Chief Executive Officer

Yeah. I think that’s a really excellent point. With our DNA medicines platform, we’re able to redose from a previous product, VGX-3100. We’ve shown that we can boost the existing T-cell responses by going in with a single-dose laser.

So, we’re really confident that we can continue to maintain the immune response that’s associated with clinical benefit, potentially augment immune response. And so, we’re very, very excited by what that means for potential long-term treatment for RRP. And as Mike said, this is a chronic, often life-long disease. So, being able to provide durable clinical benefits is really incredibly important.

In terms of the epidemiology, what we’re seeing is in most developed countries where the vaccination rates are around sort of 50% or 60%, we’re still seeing large numbers of RRP cases in adults, which don’t seem to be affected by the vaccination rates yet. The level of cases in adult seems to be holding pretty steady. And if you think about the epidemiology of RRP, you see a peak of disease cases around age five to seven, another peak in the age sort of 30 group, and then another peak in the late 50s, early 60s. And currently in the U.S.

for instance, vaccination for HPV is only around 50% in males, below 60% in females. So, a large proportion of the adult population, I think it’s been estimated at around 70%, is not protected against HPV-6 and 11. And it’s also not entirely clear how long the vaccine, the vaccine protective effects remain as well. So, unfortunately, I think it looks as though RRP is going to be with us for several generations to come.

Where we are seeing a decrease in the number of patients and the impact of vaccination is in pediatric RRP, where the number of pediatric cases are declining. But we’re not seeing any impact on cases in the adult population. And in fact, we think this is actually an under-diagnosed disease in the adult population.

Liang Cheng — Jefferies — Analyst

Got it. Very helpful. Thank you, Jackie and Mike.

Jackie Shea — President and Chief Executive Officer

Thank you.

Operator

Thank you. And there are no further questions at this time. I will now hand the call back to Ms. Jackie Shea for any closing remarks.

Jackie Shea — President and Chief Executive Officer

Thank you. As we’ve outlined here today, we are moving into 2025 with very focused strategic priorities. First and foremost is completing the next steps necessary for submitting our BLA for 3107. At the same time, we’ll be continuing to advance our commercial readiness plan, so we can hit the ground running and use our compelling product profile to its full advantage.

And finally, we’ll continue driving progress across our pipeline, advancing commenting programs like 3112 and leveraging potential partnership opportunities. This includes building on the breakthrough potential of our DMAb program and other next-gen DNA medicine technology. I’ll close today by noting that the inspiration for all of this work continues to be the patients around the world who could benefit from the power and potential of DNA medicines. For those suffering from RRP in particular, we’re strongly motivated by the understanding that every day and every surgery matters.

Thank you for your attention, and good evening, everyone.

Operator

[Operator signoff]

Duration: 0 minutes

Call participants:

Jennie Wilson — Investor Relations

Jackie Shea — President and Chief Executive Officer

Mike Sumner — Chief Medical Officer and RRP Program Lead

Steve Egge — Chief Commercial Officer

Peter D. Kies — Chief Financial Officer

Roy Buchanan — Analyst

Jay Olson — Analyst

Sudan Loganathan — Analyst

Yi Chen — H.C. Wainwright and Company — Analyst

Anish Nikhanj — Analyst

Liang Cheng — Jefferies — Analyst

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