Good afternoon, ladies and gentlemen, and welcome to the Inovio first -quarter 2026 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 Wednesday, May 13th, 2026. I would now like to turn the conference over to Jennie Willson. Please go ahead.
Good afternoon, and thank you for joining the Inovio first quarter 2026 financial results conference call. Joining me today on today's call are Dr. Jacqueline Shea, President and Chief Executive Officer; Dr. Michael Sumner, Chief Medical Officer; Steve Egge, Chief Commercial Officer; and Peter Kies, Chief Financial Officer. Today's call will review our corporate and financial information for the quarter ended March 31st, 2026, 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 statements relate to our business plans to develop Inovio's DNA medicines platform, including the FDA's ongoing review of our BLA for INO-3107, including the October 30, 2026, PDUFA target date, and our yet -to-be-scheduled meeting with the FDA to discuss eligibility for the accelerated approval program. Our belief that INO-3107 fulfills the criteria for accelerated approval and the potential benefits of INO-3107, 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-3107, if approved, and our engagement of commercial partners in preparation for a potential launch. Our collaboration with Akeso, Inc to evaluate INO-5412 in combination with a novel dual checkpoint inhibitor for the potential treatment of GBM.
The advancement of our dPROT technology platform; capital resources, including our estimated operational net cash burn of approximately $18 million for the second quarter of 2026, and the expected sufficiency of our cash resources into first quarter of 2027. Our expectations regarding competition, market size, and acceptance of INO-3107 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, 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. Jacqueline 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-3107, through the regulatory process and toward its October 30th 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 3107 has been in active review since December, when the FDA accepted the file for review under the Accelerated Approval program.
While Mike will provide a more in-depth regulatory update, I'd 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-3107 on the regulatory front, we've been advancing our commercial readiness plans, including continuing to gather key strategic insights from the RRP community.
While the majority of our resources are focused on INO-3107, we're 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're also advancing our innovative next-generation candidates and are pleased to have recently presented promising preclinical data on our DNA-encoded protein or dPROT technology work targeting factor VIII production in hemophilia A and announced two new rare disease targets. In Fabry disease and hypophosphatasia for the platform. We are laser-focused on these strategic priorities and excited about what's ahead for Inovio as we work to deliver on the promise of DNA medicine for patients. I'll now turn it over to Mike for some additional details on our regulatory progress with INO-3107. Mike?
Thanks, Jacque. As Jackie noted, since our BLA for INO was accepted for review under the Accelerated Approval Program in December of 2025, the FDA has been actively reviewing our submission. We have been responding to routine requests for information and meeting regular 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 confirmatory 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-3107 fulfills the criteria for accelerated approval by meeting a significant unmet need and providing a meaningful therapeutic benefit over existing treatments. I'd like to take a moment now to elaborate on that rationale. Based on published FDA guidance, our eligibility depends on the ability of INO-3107 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-3107 meets both of these criteria based on three factors. First, effectiveness as demonstrated in our phase I/II trial, where the vast majority of patients experienced a 50%-100% reduction in surgery in year one , and with continued clinical improvement in year two. Second, an improved safety profile that does not include required surgery to maintain minimal residual disease during the dosing window. 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-3107's eligibility for accelerated approval are the 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. We believe that every patient should have 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 adenovirus-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 third and fourth doses if visible papilloma are present to maintain a state of minimal residual disease.
This means that non-responders, or the patients for whom this product didn't work, had two 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's 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 position 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-3107 should it be approved.
These are some of the key discussion points we've 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'll now turn it over to Steve for a commercial update. Steve?
Thanks, Mike. On the commercial front, we are continuing to advance our commercial readiness plans in anticipation of a potential U.S. approval in 2026, and we're planning to manage commercialization ourselves with the support of a contract sales organization. We've completed targeting, segmentation, and product positioning work that supports a positively differentiated product profile. We've also engaged or identified key commercial partners, including a third-party logistics provider, specialty distributor, specialty pharmacy, patient hub, and agency of record. In recent months, we've 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 adenovirus-based product and INO-3107, and some of the challenges our competitor faced will not impact our launch, including the fact that we don't require an ultra-cold chain, and we don't require surgery to maintain minimum residual disease during the dosing window. We've also continued to gather important insights from the RRP community and recently attended the Combined Otolaryngology Spring Meetings, or COSM, a key conference for laryngologists. In conversations at that conference with physicians 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-3107 that has a positively differentiated product profile across efficacy, tolerability, and simplicity of the treatment regimen. I'll now turn it back to Jackie for a pipeline update. Jackie?
Thanks, Steve. With our resources focused primarily on INO-3107, partnerships will continue to be a key part of our strategy to advance other promising candidates in our pipeline. In March this year, we announced an innovative collaboration with Akeso to evaluate INO-5412 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 II adaptive platform trial sponsored by the Dana-Farber Cancer Institute. We've also continued to advance our exciting next-generation DNA medicine platform and shared research on our DNA-encoded protein, or dPROT , technology targeting factor VIII at several key conferences, including the World Federation of Hemophilia World Congress and the American Society of Gene & Cell Therapy Annual Meeting.
Building on the promising DNA-encoded monoclonal antibody 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 VIII 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'll turn it over to our CFO, Peter Kies, for a financial update. Peter?
Thanks, Jacque. Today I'd like to provide an overview of Inovio's financial results for the first quarter of 2026. As Jacque noted, our primary goal is to advance INO-3107 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 first quarter of 2026 with $37.7 million in 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 the first quarter of 2027, beyond the target PDUFA date of INO-3107.
This projection includes an operational net cash burn estimate of approximately $18 million for the second quarter of 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 to our results to the first quarter, operating expenses dropped from $25.1 million in the first quarter of 2025- $21.9 million in the first quarter of 2026, a 13% decrease. Inovio's net loss for the first quarter of 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 first quarter of 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. With that, I'll turn it back over to Jacque .
Thanks, Peter. I'd now like to pause to open up the call to answer any questions you might have. Operator?
Thank you. Ladies and gentlemen, we will now begin the question and answer session. One moment , please, for your first question. Your first question comes from Ted with Piper Sandler. Please go ahead.
Great. Thank you very much for taking the questions. I really appreciate it. It sounds like things are going well with the review. I saw the Papzimeos numbers of 22 versus 21.6, which look pretty good. Any comments? Can you expand a little more about how you expect to launch and differentiate versus the currently marketed products? Thanks.
Hi, Ted Nice to hear from you. Steve, do you want to take that one?
Sure. Hey, Ted. Yeah. We saw the Precigen performance as well. Kind of how we're thinking about the market and how we'll compete is, you know, we have a, we think, positively differentiated product profile when we look across efficacy, tolerability, and the simplicity of the treatment regimen. We think we can be well-differentiated in the market. The overall market opportunity itself, you know, there's a very significant number of patients. 14,000 RRP patients is the most kind of published number, although that's quite dated. Our own estimate of claims data, you know, demonstrates that that's probably a significant underestimate. I think Precigen has noted 27,000 RRP patients.
By the time we get to market, we expect, you know, Precigen, or Papzimeos would have had single-digit penetration into the market in the first year. The vast majority of the opportunity will remain by the time we get to market. We do expect to be a fast-following second entrant. There's many examples of second entrants, you know, fast following that do very, very well in the market and, in some cases, take market leadership.
If I can just add here, Steve. I think, you know, the Papzimeos launch also gives us the opportunity to learn from their successes and challenges, and we'll certainly be baking those learnings into our go-to-market plans as well. I think, you know, the progress that we see Precigen making in the marketplace is really an indication of the high met need, for these patients, for therapeutic-
Yep
alternatives to surgery.
Very great.
We're really excited by the opportunity for INO-3107.
Very great. If I may, just a quick follow-up. When it comes to this informal meeting with FDA, what are the primary issues that you intend to discuss there?
Mike?
Yeah, happy to. I mean, yeah, I mean, this is really about confirming our accelerated approval eligibility. I think it's —I don't think we'll have much discussion around the clinical unmet need. That's very, it's very obvious, I think—to everybody concerned. It's really around the discussion of meaningful therapeutic benefit. As we've stated, we firmly believe we have a significant safety advantage without the requirement for those minimal residual disease surgeries. Our differentiated mechanism of action will enable us to treat patients that the existing product won't be able to.
Great. That's really helpful. I appreciate how you laid it out in the call earlier. Thanks very much.
Thank you. Your next question comes from Jay with Oppenheimer. Please go ahead.
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 thirty-one oh seven and remind us any additional data or evidence that you have submitted or will submit? I had a follow-up, if I could, please.
Yeah, sure. Nice to hear from you, Jay. I'll start off, and then I'll ask Mike to chip in here. 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. That assessment aid doesn't include any new clinical data, but it did include additional analysis of the data that we performed. At the upcoming meeting, as Mike indicated, what we principally expect to be discussing with the agency are the arguments that we've laid out in the BLA and also in the assessment aid as to why we believe INO-3107 is eligible for review under the accelerated approval pathway.
That's really around providing meaningful therapeutic benefit over the existing product, and INO-3107 has the potential to meet this unmet need. Mike, do you want to go into some more specifics?
I mean, I certainly can. I mean, in terms of the differentiated mechanism of action, which should enable us to treat a different patient population than Papzimeos. We've 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. We've also talked about their the requirement that they have for performing those minimal residual disease surgeries is based on the immunosuppressive path and the microenvironment that they utilize those surgeries to overcome. We have shown with our data that was published in Nature Communications that the elements that Precigen identified did not impact the efficacy of INO-3107. We believe there's a meaningful therapeutic difference of the two products.
I think also when you look at the two different platforms, you know, we've 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.
Great. That's super helpful. Thank you. If I could just ask one 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 do you expect to receive from the FDA?
Yeah. Great, 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. I think as part of the informal meeting and discussion of the review pathway, we would hope to learn when we'll get feedback on that confirmatory trial design.
Okay, great. We'll look forward to that. Thanks for taking the questions.
My pleasure.
Thank you. Your next question comes from Sudhan with Stephens. Please go ahead.
Thanks. Hi, everyone. Thank you for the updates; it's great to hear all the progress. To piggyback off of the confirmatory trial question that was just asked, you know, since there is still a high unmet medical need for RRP, you know, despite Papzimeos being on the market, can you let us know to what capacity you're still treating old or new patients with INO-3107? Secondly, will you get any longer-term durability of response data from INO-3107 this year since, if I remember correctly, INO-3107 shined on the previous long-term analysis readout?
Thanks, Sudhan, for the question. Our original phase I/II trial incorporated the initial four-dose regimen. The follow-up data was actually just a retrospective look back on the same patient population with no additional dosing. We, at present, do not have any planned readout of data on INO-3107 with continued dosing. We have previously talked about data that we have for VGX-3100, which has shown the ability to continue generate a T-cell response six-nine months after the completion of the initial treatment. We are excited to discuss with the agency what a redosing strategy will look like following approval of INO-3107 if it gets approved.
Great. Secondly, I just wanted to also ask, how have your interactions with the RRP Foundation been recently as you near your PDUFA date amidst also the Papzimeos launch, currently happening? Do 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, has currently only penetrated about 25% to date?
That's a great question, Sudhan, and I'm very pleased to say that the RRPF Foundation and the RRP community have been incredibly supportive. We've, you know, we're very much aligned with them. We recognize that the current approved therapy doesn't work for all RRP patients, and every RRP patient deserves a therapy that works for them. Every surgery matters to RRP patients. Our goals are very much aligned with the foundation's. We continue to work very closely with them, and we're very grateful for their support, and we'll obviously continue to work with them going forward. Yes, understanding the patient perspective and the remaining unmet need is absolutely critical to what we're trying to do with INO-3107.
Sudhan, any follow-ups?
All good. Thank you so much. I appreciate the details.
Thank you. Your next question comes from Yi Chen with H.C. Wainwright. Please go ahead.
Thank you for taking my question. This is Yan Zi sitting in for Yi Chen. I have two questions. The first is with respect to the FDA. Do you expect the resignation of the current FDA commissioner to introduce any sort of uncertainty in the review timeline of INO-3107?
Yeah, I don't think we can really comment on the inner workings of the FDA at the moment. 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 that they're still reviewing the assessment aid and that they plan to schedule the informal meeting. We continue to encourage them to schedule that meeting. We're keen to discuss it with them. I think, you know, where we are at the moment is really just continuing to progress the review, and we're very keen to have that discussion.
Thank you. My second question is about when INO-3107 gets approval. Once that happens, what would be your marketing strategy or approach to seize market share from bexarotene?
Yeah. We believe, as Steve, I think, has outlined, that INO-3107 has a positively differentiated product profile and could become the product of choice for patients and RRP physicians. This is really based on our clinical effectiveness, our tolerability, and a simple patient-centric approach to treatment with INO-3107. Clearly, we've been learning from the bexarotene launch. We'll be incorporating key learnings from their launch into our go-to-market plan, and we're planning to be a fast follower. As Steve also outlined, we're expecting the vast majority of the prevalent pool, or the available market, to still be available when we come to market, if approved. There are also new patients being diagnosed every year. We think we're in a good position to be able to compete with the approved product.
Steve, anything you want to add?
No, I think that's good.
Anything. Any follow-up?
Thank you again.
Oh, thank you. Your last question comes from Liang Cheng with Jefferies. Please go ahead.
Hey, this is Liang Cheng, for Roger Song. Thank you for taking our questions. I guess, from us, how should we think about the potential label at approval, particularly the eligible patient population and the anticipated restrictions versus the phase I/II population?
Hi. Nice to hear from you, and it's a great question. We would expect to have a very similar label to the approved product, and that's based on the fact that we recruited patients who had had between two- eight surgeries in the prior year. In our patient population, we had a good balance of patients who were infected with HPV six and 11 and even a combination of them both. 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. We would expect a very similar label with no restrictions.
Okay. Got it. At a higher level, how are you thinking about the pricing relative to the procedure?
Yeah. We are thinking of rare disease pricing. Clearly, in our payer research that we've conducted, payers recognize that rare disease pricing is appropriate for this indication. We'll be conducting some price optimization research. We'll be commenting on pricing a bit closer to launch.
Got it. Thank you.
Thank you. There are no further questions at this time. I will turn the call back over to Jacqueline Shea.
Thank you. As we've outlined here today, Inovio is intent on meeting the milestones ahead for INO-3107 and the other promising candidates in our pipeline. We're motivated by the potential opportunity to deliver on the promise of DNA medicine for RRP patients and 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're working every day to help make that vision a reality. Thank you for your attention, and good evening, everyone.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.