Inovio (INO) Q1 2026 Earnings Call Transcript

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Date

Wednesday, May 13, 2026 at 4:30 p.m. ET

Call participants

• President and Chief Executive Officer — Jacqueline E. Shea
• Chief Financial Officer — Peter D. Kies
• Chief Medical Officer — Michael Sumner
• Chief Commercial Officer — Steven Egge

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Takeaways

• Regulatory progress for INO-3.11 thousand -- The FDA completed mid-cycle review of the BLA with "no new significant issues being raised," and the late-cycle review is scheduled for the third quarter.
• Accelerated approval dialogue -- Michael Sumner reiterated intent to schedule an informal meeting to discuss "eligibility for review under the accelerated approval program" as noted in the file acceptance letter.
• Clinical efficacy of INO-3.11 thousand -- Phase 1/2 trial data showed "the vast majority of patients experienced a 50% to 100% reduction in surgery in year 1," with continued clinical improvement in year 2.
• Safety profile -- Management stated INO-3.11 thousand's dosing "does not include required surgery to maintain minimal residual disease during the dosing window."
• Differentiated mechanism -- The product's mechanism of action "does not come with the risk of reduced clinical effectiveness due to known immune factors" impacting the approved competitor (e.g., "Including preexisting neutralizing antibodies, or an immunosuppressive tumor microenvironment").
• Commercial readiness -- Inovio Pharmaceuticals (NASDAQ:INO) has "completed targeting, segmentation, and product positioning work," and identified commercial partners for product launch, including a 3PL provider, specialty distributor, and agency of record.
• Competitive positioning -- INO-3.11 thousand does not require "an ultra cold chain" or "surgery to maintain minimum residual disease," differentiating it from the currently approved gorilla adenoviral-based product.
• Market opportunity -- Management estimates a U.S. RRP patient population higher than 14,000 and referenced a competitor estimate of 27,000; they expect "the vast majority of the opportunity will remain" at launch.
• Pipeline expansion -- In March, Inovio announced a collaboration with Akeso and Dana-Farber Cancer Institute to evaluate INO-5.4 thousand in a Phase 2 glioblastoma study.
• Next-generation platform -- Positive preclinical data were presented for dPROT technology targeting Factor 8 in hemophilia A, with development expanding into Fabry disease and hypophosphatasia.
• Cash balance -- Ended the quarter with $37.7 million in cash, cash equivalents, and short-term investments, compared to $58.5 million at December 31, 2025; April public offering added $16 million in net proceeds, extending estimated cash runway into 2027.
• Operational cash burn -- Estimated 2026 operational net cash burn is approximately $18 million.
• Operating expenses -- Operating expenses decreased 13% to $21.9 million from $25.1 million in the prior-year period.
• Net loss -- Reported net loss of $19.7 million or $0.28 per share basic and dilutive, unchanged in dollar terms from the prior year, though the loss per share was $0.51 in the comparable 2025 period.

Summary

Inovio Pharmaceuticals advanced its lead asset, INO-3.11 thousand, through the FDA’s review process, receiving a mid-cycle review with no new significant issues and confirmation that a late-cycle review is scheduled. Management emphasized potential differentiation of INO-3.11 thousand in clinical benefit, safety, and patient experience compared to the current market entrant, supported by specific trial data and physician community feedback. Commercial preparations are complete, partnerships are established, and market analysis suggests a large unpenetrated patient pool at launch. Resources remain concentrated on INO-3.11 thousand’s approval, while next-generation pipeline efforts continue, and a recent equity offering has extended financial runway past anticipated regulatory milestones.

• The company highlighted communications from Michael Sumner stating, "reiterated their intent to schedule the previously agreed to informal meeting to discuss this potential review issue. Which they noted in their file acceptance letter."
• Leadership detailed that the assessment aid submitted in February "does not include any new clinical data, but it does include additional analysis of the data that we performed."
• Current clinical data for INO-3.11 thousand, including the absence of a need for additional surgeries during dosing, underpins Inovio’s case for "meaningful therapeutic benefit over existing treatments."
• Management identified that most of the addressable market is expected to remain available at launch, with competitor uptake described as "single digit penetration into the market in its first year."
• No additional long-term efficacy data for INO-3.11 thousand are expected this year, as ongoing clinical data collection is limited to previously dosed patients and retrospective analyses.
• Company stated that projected label could be "very similar label to the approved product," encompassing a broad patient population without additional restrictions.

Industry glossary

• BLA (Biologics License Application): A formal submission to the FDA requesting approval to market a biological product in the United States.
• PDUFA date: The Prescription Drug User Fee Act target action date by which the FDA aims to complete its regulatory review.
• RRP (Recurrent Respiratory Papillomatosis): A rare disease characterized by the growth of benign tumors in the respiratory tract, associated with HPV infection.
• dPROT technology: Inovio’s DNA-encoded protein platform designed for sustained in vivo expression of therapeutic proteins.
• 3PL provider: Third-party logistics provider, handling distribution and supply chain management for pharmaceutical products.

Full Conference Call Transcript

Jennie Willson: Good afternoon, and thank you for joining the Inovio First Quarter 26 Financial Results Conference Call. Joining me today on today's call are Doctor. Jacqueline E. Shea, President and Chief Executive Officer Doctor Michael Sumner, chief medical officer Steven Egge, chief commercial officer and Peter D. Kies, chief financial officer. Today's call will review our corporate and financial information for the quarter ended March 31, 2026 as well as provide a general business update. Following prepared remarks, we will conduct 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 statements relate to our business plans to develop Inovio's DNA medicines platform, including the FDA's ongoing review of our BLA for INO-3.11 thousand including the October 30, 2026 PDUFA target date and are yet to be scheduled meeting with the FDA to discuss eligibility for the Accelerated Approval Program. Our belief that INO-3.11 thousand fulfills the criteria for accelerated approval, the potential benefits of INO-3.11 thousand including our belief that it has a positively differentiated product profile and the potential to become the preferred product by patients and their physicians if approved. The anticipated commercial launch of INO-3.11 thousand if approved, and our engagement of commercial partners and preparation for a potential launch.

Our collaboration with Akeso, Inc. to evaluate INO-5.4 thousand in combination with a novel dual checkpoint inhibitor, the potential treatment of GBM, the advancement of our dPROT technology platform, capital resources, including our estimated operational net cash burn of approximately $818 million for 2026 and the expected sufficiency of our cash resources into 2027. And our expectations regarding competition market size, and acceptance of INO-3.11 thousand if approved. 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 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.enovio.com, and a replay will be made available shortly after the call is concluded. I will now turn the call over to Inovio's President and CEO, Doctor. Jacqueline E. Shea.

Jacqueline E. Shea: Good afternoon. And thank you to everyone for joining today's call. These are very busy times at Inovio. As we remain focused on achieving our top priority, advancing our lead candidate, INO-3.11 thousand through the regulatory process and toward its October 30 target PDUFA date. Our goal is to ensure that every patient with recurrent respiratory papillomatosis or RRP has access to a therapeutic option that can work for them to reduce the need for surgery. If approved, we believe that our innovative therapy has the potential to become the preferred product for patients suffering from RRP, a rare and debilitating disease of the respiratory tract. With a critically high unmet need for effective non surgical treatment options.

The BLA for INO-3.11 thousand has been in review since December. When the FDA accepted the path for review, under the accelerated approval program. While Mike will provide a more in-depth regulatory update, I would like to comment on a couple of key highlights. The FDA recently completed their standard mid cycle review with no new significant issues being raised. And scheduled the late cycle review for the third quarter. As you will recall from our last quarterly update, the FDA had previously agreed to an informal meeting to discuss the potential review issue they noted in their file acceptance letter. Regarding eligibility for review under the accelerated approval program.

As a part of communications, about the mid cycle review, they reiterated their intent to schedule that meeting, and we look forward to the discussion. While we make progress with INO-3.11 thousand on the regulatory front, we have been advancing our commercial readiness plans including continuing to gather key strategic insights from the RRP community. And while the majority of our resources are focused on INO-3.11 thousand we are continuing to leverage the power of partnerships to advance other promising candidates in our pipeline. Including an exciting opportunity to work with Akeso and the Dana-Farber Cancer Institute to build on our previous immuno oncology work in glioblastoma. or GBM.

We are also advancing our innovative next generation candidates, and I am pleased to have recently presented promising preclinical data on our DNA encoded protein or dPROT technology work targeting Factor 8 production in hemophilia A. And announced 2 new rare disease targets. In Fabry disease, and hypophosphatasia. For the platform. We are laser focused on these strategic priorities and excited about what is ahead for Inovio as we work deliver on the promise of DNA medicine for patients. I will now turn it over to Mike for some additional details on our regulatory progress with INO-3.11 thousand. Mike?

Michael Sumner: Thanks, Jackie. As Jackie noted, since our BLA for INO-3.11 thousand was accepted for review under the accelerated approval program, in December 2025, the FDA has been actively reviewing our submission. We have been responding to routine requests for information and meeting regular top milestones in the review process. Including the FDA completing its mid cycle review of our BLA. Where no new significant issues were raised. At the time of the mid cycle review, the FDA indicated that it is continuing to review the assessment aid we submitted in February. Which outlined our rationale for accelerated approval program eligibility They also reiterated their intent to schedule the previously agreed to informal meeting to discuss this potential review issue.

Which they noted in their file acceptance letter. In addition, we reported last quarter that we had submitted an updated protocol for our confirmed trial to the IND. Which is required under the accelerated approval program. We are waiting for feedback from the agency on both the informal meeting and the confirmatory trial protocol. So we can finalize the study design. We look forward to having the opportunity to discuss these issues further with the FDA. And to emphasize why we believe that INO-3.11 thousand fulfills the criteria for accelerated approval. By meeting a significant unmet need and providing a meaningful therapeutic benefit over existing treatments. I would like to take a moment now to elaborate on that rationale.

Based on published FDA guidance, our eligibility depends on the ability of INO-3.11 thousand to provide a meaningful therapeutic benefit over existing treatments. And the ability to meet a remaining critical unmet need among patients. We believe that INO-3.11 thousand meets both of these criteria, based on 3 factors. First, effectiveness as demonstrated in our Phase 1/2 trial. Where the vast majority of patients experienced a 50% to 100% reduction in surgery in year 1. And with continued clinical improvement in year 2. Second, an improved safety profile that does not include required surgery to maintain minimal residual disease during the dosing window.

And third, a differentiated mechanism of action that does not come with the risk of reduced clinical effectiveness due to known immune factors that impact the efficacy of the approved product. Including preexisting neutralizing antibodies, or an immunosuppressive tumor microenvironment thus providing an important opportunity to treat patients who are not served by existing therapy. It is important to emphasize again that at the heart of our belief in INO-3.11 thousand's eligibility for accelerated approval, are the patients. Patients who face the risk of permanent damage to the vocal cords and significant social, emotional, and financial costs every time they require surgery to manage their disease.

Every surgery matters to patients, and we believe that every patient has access to a treatment option that works for them. To reduce the need for surgery. A compelling example of the remaining unmet need for therapeutic options for RRP patients is the fact that the recently approved gorilla adenoviral-based immunotherapy does not work for a number of patients. According to that product's published data. Further, the treatment regimen for this product requires surgery prior to the 3rd and 4th doses if visible papilloma are present. To maintain a state of minimal residual disease.

This means that nonresponders or the patients for whom this product did not work had 2 surgeries during the treatment window and then saw no clinical benefit or improvement in the following year. According to the published clinical trial data. that is why additional treatment options are so critical for the RRP community. There will continue to be patients not served by existing therapy. This need was highlighted in a recently published RRP foundation sponsored physician statement, where 16 leading RRP physicians outlined a contemporary evidence based approach to the management of RRP in adults. They highlighted the benefits of HPV specific immunotherapy to address the underlying disease that causes RRP.

And recommended HPV specific immunotherapy as the preferred first line therapy for adults. Including the recently approved immunotherapy and INO-3.11 thousand should it be approved. These are some of the key discussion points we have provided to the FDA. And we look forward to having the opportunity to discuss them further. In the meantime, we will continue working collaboratively with the agency to advance our BLA through the regulatory process. I will now turn it over to Steven for a commercial update.

Steven Egge: Thanks, Mike. On the commercial front, we are continuing to advance our commercial readiness plans in anticipation of a potential US approval in 2020, and we are planning to manage commercialization ourselves with the support of a contract sales organization. We have completed targeting, segmentation, and product positioning work that supports a positively differentiated product profile. We have also engaged or identified key commercial partners including a 3PL provider, specialty distributor, specialty pharmacy, patient hub, and agency of record. In recent months, we have also been watching and incorporating key learnings from the launch of our competitor's recently approved product, noting where they seem to be having success or challenges in optimizing our own commercial plans accordingly.

Importantly, there are key differences between the gorilla adenoviral-based product and INO-3.11 thousand. And some of the challenges our competitor faced will not impact our launch. Including the fact that we do not require an ultra cold chain and we do not require surgery to maintain minimum residual disease. During the dosing window. We have also continued to gather important insights from the RRP community and recently attended the combined Otolaryngology Spring Meeting or COSM, a key conference for laryngologists. In conversations at that conference with physician specializing in the treatment of RRP, we heard repeatedly that there continues to be a high unmet need for effective immunotherapy options that work for each patient.

Both patients and doctors are highly motivated and very receptive to new treatments which indicates that this market has significant unmet need and commercial opportunity particularly for a potential product like INO-3.11 thousand that has a positively differentiated product profile across efficacy, tolerability, and simplicity of the treatment regimen.

Jacqueline E. Shea: I will now turn it back to Jackie for a pipeline update. Jackie? Thanks, Steven. With our resources focused primarily on INO-3.11 thousand partnerships will continue to be a key part of our strategy. To advance other promising candidates in our pipeline, In March, we announced an innovative collaboration with Akeso, to evaluate INO-5.4 thousand in combination with their novel dual checkpoint inhibitor as a potential treatment for glioblastoma. The most common and aggressive form of brain cancer. The study, which builds on our previous promising research in GBM, will be part of a Phase 2 adaptive platform trial sponsored by the Dana Farber Cancer Institute.

We have also continued to advance our exciting next generation DNA platform and shared research on our DNA-encoded protein or dPROT technology targeting Factor 8 at several key conferences including the World Federation of Hemophilia Global Conference, and the American Society of Gene and Cell Therapy Annual Meeting. Building on the promising DNA encoded monoclonal research published in Nature Medicine last year, Our dPROT technology aims to enable long term protein expression within the body. And address the shortcomings of conventional therapeutic protein or enzyme replacement therapies. Based on positive preclinical data on Factor 8 production for hemophilia A, Inovio is developing additional dPROT indications in the rare disease space. Including Fabry disease, and hypophosphatasia.

And is in discussions with potential partners to accelerate development of this promising platform. Now I will turn it over to our CFO, Peter D. Kies, for a financial update.

Peter D. Kies: Thanks, Jackie. Today, I would like to provide an overview of Inovio's financial results for the 2026. As Jackie noted, our primary goal is to advance INO-3.11 thousand towards approval. And we remain focused on optimizing resources to support that program. I am pleased to report that the company strengthened its balance sheet with an underwritten public equity offering in April 2026. Net proceeds from the offering after deducting underwriter discounts, commissions, and offering expenses, were approximately $16 million. We finished the 2026 with $37.7 million in cash, cash equivalents and short term investments. Compared to $58.5 million as of December 31, 2025. With the addition of the April public offering, we have extended our estimated cash runway into 2027.

Beyond the target PDUFA date, of INO-3.11 thousand. This projection includes an operational net cash burn estimate of approximately $18 million for 2026. These cash runway projections do not include any further capital raise activities that we may undertake and are based on current projections and assumptions. Turning our results to the first quarter, operating expenses dropped from $25.1 million in 2025 to $21.9 million in 2026, a 13% decrease. Inovio's net loss for the 2026 was $19.7 million or $0.28 per share basic and dilutive. Compared to a net loss of $19.7 million or $0.51 per share basic and dilutive for the 2025.

As a reminder, you can find our full financial statements in this afternoon's press release as well as in our quarterly report on Form 10 Q filed with the SEC. And with that, I will turn it back over to Jackie.

Jacqueline E. Shea: Thanks, Peter. I would now like to pause to open up the call to answer any questions you might have. Operator?

Operator: 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 1 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 2. If you are using a speaker phone, please lift the handset before pressing any keys. 1 moment please for your first question. Your first question comes from Ted Tenthoff with Piper Sandler. Please go ahead.

Analyst (Ted): Great. Thank you very much for taking the questions. I really appreciate it. And it sounds like, things are going well with the review. I saw the Papzimeos numbers of 2022 were $21.6 million, looks like pretty good. Any comments Can you expand a little more about how you expect to launch and differentiate versus the currently marketed product?

Jacqueline E. Shea: Hi, Ted. Nice to hear from you. Steven, you want to take that 1?

Steven Egge: Sure. Hey, Ted. Yeah. So we saw the depression performance as well, and kind of how we are thinking about the market and how we will compete is, we have a, we think, a positively differentiated product profile when we look across efficacy, tolerability, and the simplicity of the treatment regimen. So we think we can be well differentiated in the market. And then the overall market opportunity itself, you know, there is a very significant number of patients. 14 thousand RRP patients is the most kind of recently published number, although that is quite dated. And our own estimate of claims data, you know, demonstrates that is probably a significant underestimate.

I think Precigen has noted 27 thousand RRP patients. So by the time we get to market, we expect, you know, Precigen or Pepcimios would have had single digit penetration into the market in its first year. So the vast majority of the opportunity will remain by the time we get to market, and we do expect to be a fast-following second entrant, and there is many examples of second entrants, fast following that do very, very well in the market and in some cases, take, take market leadership.

Jacqueline E. Shea: And if I can just add here, Steven, I think the launch also gives us the opportunity to learn from their successes and challenges. And we will certainly be baking those learnings into our go to market plans as well. So I think the progress that we see Precision making in the market marketplace is really an indication of the high met need of these patients for therapeutic alternatives. Surgery. We are really excited by the opportunity for INO-3.11 thousand.

Analyst (Ted): Very great. And then if I may just a quick follow-up. When it comes to this informal meeting with FDA, the-- what are the primary issues that you intend to discuss there?

Jacqueline E. Shea: Mike?

Michael Sumner: Yes. Happy to. So, I mean, yeah, I mean, this is really about confirming accelerated approval eligibility. I think it is I do not think we will have much discussion around the, clinical unmet need. that is very-- it is very obvious, I think, to every concerned. So it is really around the discussion of meaningful therapeutic benefit. And as we have stated, we firmly believe we have a significant safety advantage without the requirement for those minimal residual disease surgeries, and a differentiated mechanism of action will enable us to treat patients that the existing product will not be able to. Great. that is really helpful. And I appreciate how you like laid it out on the call earlier.

Analyst (Ted): Thanks very much.

Operator: Thank you. Your next question comes from Jay Olson with Oppenheimer. Please go ahead.

Analyst (Jay): Oh, hey. Thanks for providing this update and taking the questions. Can you just maybe talk about some of the key discussion points with the FDA when you meet on INO-3.11 thousand and remind us any additional data or evidence that you have submitted or will submit And then, I had a follow-up if I could, please.

Jacqueline E. Shea: Yeah. Sure. So nice to hear from you, Jay. So I will start off, and then I will ask Mike to chip in here. So if you remember, we submitted our assessment aid to FDA back in February. Ahead of the informal meeting, and that was in direct response to a request from the agency And that assessment aid does not include any new clinical data, but it does include additional analysis of the data that we performed.

So at the upcoming meeting, as Mike indicated, what we expect to be discussing with the agency Are the arguments that we have laid out in the BLA and also in the assessment aid as to why we believe INO-3.11 thousand is eligible for review under the accelerated approval pathway. And that is really around providing meaningful therapeutic benefit over the existing product and that INO-3.11 thousand has the potential to meet this unmet need. Mike, do you want to go in there into some more specifics?

Michael Sumner: I mean, I certainly can. I mean, in terms of the differentiated mechanism of action, which should enable us to treat different patient population than Papzimeos. We have talked previously about the presence of neutralizing antibodies to the gorilla adenoviral platform that will decrease the immune response that those patients will see with Papzimeos. And we have also talked about the requirement that they have for performing those minimal residual disease surgeries is based on the immunosuppressive papilloma that they utilize those surgeries to overcome. We have shown with that data that was published in Nature Communications that the elements that Precigen identified did not impact the efficacy of INO-3.11 thousand.

So we believe there is a meaningful therapeutic difference of the 2 products. And I think also into when you look at the 2 different platforms, now we have talked about DNA medicines having the capability of redosing and continuing to generate that T cell response. RRP is a chronic viral illness. And we believe redosing is going to be an important part of the treatment regimen to ensure these patients can hopefully become surgery free long term.

Analyst (Jay): Great. that is super helpful. Thank you. And if I could just ask 1 follow-up. Could you please talk about when you expect to receive feedback from the FDA on the confirmatory study design and what sort of feedback you expect to receive from the FDA?

Michael Sumner: Yeah. Great question, Jay. I mean, we expect to as the confirmatory trial design is really linked to the review pathway and the requirement to conduct that confirmatory trial. We would expect that feedback to be linked to the informal meeting. So I think as part of the informal meeting and discussion of the review pathway, we would hope to learn when we will get feedback on that confirmatory trial design.

Analyst (Jay): Okay. Great. We will look forward to that. Thanks for taking the questions. My pleasure.

Operator: Thank you. Your next question comes from Sudan Loganathan with Stephens. Please go ahead.

Analyst (Sudan): Thanks. Hi, everyone. Thank you for the updates, and great to hear all the progress. To piggyback off of the confirmatory trial, question that was just asked, since there is still a high unmet medical need for RRP, despite the Papzimeos being on the market, can you let us know to what capacity you are still treating old or new patients with INO-3.11 thousand? And secondly, will you get any longer term durability of response data from INO-3.11 thousand this year since I remember correctly, yeah, INO-3.11 thousand shined on the previous long term analysis readout.

Michael Sumner: Yeah. Thanks, Sudan, for the question. I mean, our original Phase 1/2 trial incorporated the initial 4-dose regimen. And then the follow-up data was actually just a retrospective look back on the same patient population with no additional dosing. So we at present, we do not have any planned readout of data around INO-3.11 thousand with continued dosing. We have previously talked about data that we have for INO 31 hundred. Which has shown the ability to continue generate a T cell response 6 to 9 months after the completion of the initial treatment. So we are excited to discuss with the agency what a redosing strategy will look like following approval of INO-3.11 thousand. If it gets approved.

Analyst (Sudan): Great. And secondly, just wanted to ask also how have your interactions with the RRP Foundation been recently you near your PDUFA date, amid also the Papzimeos launch, currently happening? You feel like you have an opportunity here to further utilize this patient advocacy group as a resource to specifically reach the community setting that Papzimeos, I think, currently has only penetrated about 25% to date.

Jacqueline E. Shea: Yeah. that is a great question, Sudan. And I am very pleased to say that the RLPF Foundation and the RRP community have been incredibly supportive. And we are very much aligned with them. We recognize that the current approved therapy does not work for all RRP patients. And every RRP patient deserves a therapy that works for them. Every surgery matters to RRP patients So our goals are very much aligned with the foundation We continue to work very closely with them, and we are very grateful for their support. And we will obviously continue to work with them going forward.

But, yes, understanding the patient perspective and the remaining unmet need is absolutely critical to what we are trying to do with INO-3.11 thousand.

Michael Sumner: Sudan, any follow-up?

Analyst (Sudan): All good. Thank you so much. I appreciate the details.

Operator: Thank you. Your next question comes from Yi with H. C. Wainwright. Please go ahead.

Analyst (Yanzi): Thank you for taking my question. This is Yanzi sitting in for Yi Chen. I have 2 questions. The first is with respect to the FDA. Do you expect the resignation of the current FDA commissioner to introduce any sort of delay in the review timeline of INO-3.11 thousand?

Michael Sumner: Yep. I do not think we can really comment on the inner workings of the FDA at the moment. But what I can say is, you know, we continue to engage with our review team and respond to information requests, and the review seems to be proceeding. As we commented around the mid cycle review, they did reiterate they are still reviewing the assessment aid and that they plan to schedule the informal meeting. And we encourage them to we continue to encourage them to schedule that meeting. We are keen to discuss it with them.

So I think, you know, where we are at the moment is really just continuing to progress the review, and we are very keen to have that discussion.

Analyst (Yanzi): Thank you. And, my second question is about, when INO-31 zero 7 gets approval. So once that happens, what would be your marketing strategy or approach to seize market shares from Papzimeos?

Jacqueline E. Shea: Yeah. So we believe, as Steven has outlined, we believe INO-3.11 thousand has a positively differentiated product profile and could become the product of choice for patients and RRP physicians. And this is really based on our clinical effectiveness, tolerability, and a simple patient centric approach to treatment with INO-3.11 thousand. So, clearly, we will we have been learning from the Papzimeos's launch. We will be incorporating key learnings from their launch into our go to market plan. We are planning to be a fast follower.

As Steve also outlined, we are expecting the vast majority of the prevalent pool or the available market to still be available when we come to market if approved. and there are also new patients being diagnosed every year. So we think we are in a good position to be able to compete with the approved product. Steven, anything you want to add?

Steven Egge: No. I think that is good. You cannot anymore.

Analyst (Yanzi): Oh, thank you.

Operator: Last question comes from Liang Cheng with Jefferies. Please go ahead.

Analyst (Liang Chen): Hey. This is Liang Cheng on for Roger Song.Thank you for taking our questions. I guess from us, how should I think about the potential label at approval? Particularly the eligible patient population and anticipated restrictions versus the Phase 1/2 population.

Michael Sumner: Hi. Nice to hear from you. it is a great question. So we would expect to have a very similar label to the approved product, and that is based on the fact that we recruited patients who had between 2 to 8 surgeries in the prior year. In our patient population, we had a good balance of patients who were infected with HPV 6 and 11 and even a combination of them both. And we have no evidence from our mechanism of action that efficacy would depend on severity of disease or number of surgeries in the prior year. So we would expect a very similar label with no restrictions.

Analyst (Liang Chen): Okay. Got it. And the high the higher level, what how are you thinking about the pricing relative to Precigen?

Jacqueline E. Shea: Yep. So we are thinking of rare disease pricing. Clearly, in our payer research that we have conducted, payers recognize the rare disease pricing is appropriate for this indication. We will be conducting some price optimization research and then we will be commenting on pricing a bit closer to launch.

Analyst (Liang Chen): Got it. Thank you.

Operator: Thank you. There are no further questions at this time. I will turn the call back over to Jackie Shea.

Jacqueline E. Shea: Thank you. As we have outlined here today, Inovio is intent on meeting the milestones ahead for INO-3.11 thousand and the other promising candidates in our pipeline. We are motivated by the potential opportunity to deliver on the promise of DNA medicines for RRP patients. I am grateful for the support from the RRP Foundation and larger RRP community. They have waited so long for relief from the devastating impact of their disease. We believe every patient deserves access to a treatment option that works for them, because every patient matters and every surgery matters. We are working every day to help make that vision a reality. Thank you for your attention and good evening, everyone.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

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