Inovio Pharmaceuticals, Inc.INONASDAQ
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Operator: Good afternoon, ladies and gentlemen, and welcome to the Inovio Third Quarter 2025 Financial Results Conference Call. [Operator Instructions] This call is being recorded on Monday, November 10, 2025. And I would now like to turn the conference over to Jennie Wilson. Thank you. Please go ahead.
Jennie Willson: Good afternoon and thank you for joining the Inovio Third Quarter 2025 Financial Results Conference Call. Joining me today on today's call are Dr. Jacqui 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 ended September 30, 2025, as well as provide a general business update. Following prepared remarks, we will conduct a question-and-answer session. During the call, we will be making forward-looking statements regarding future events and the future performance of the company. These events relate to our business plans to develop Inovio's DNA medicines platform, which include clinical and regulatory developments and timing of clinical data readouts and planned regulatory submissions of our request for priority review by the FDA of our BLA submission for INO-3107 and our expectation that the FDA will accept the submission by the end of 2025, along with capital resources, including the sufficiency of our cash resources, our expectations regarding competition, the size and growth of the potential markets for INO-3107, if approved, and our ability to serve those markets, the rate and degree of market acceptance of INO-3107 and strategic matters. All of these statements are based on the beliefs and expectations of management as of today. Actual events or results could differ materially. We refer you to the documents we file from time to time with the SEC, which under the Risk Factors heading identify important factors that could cause actual results to differ materially from those expressed by the company verbally as well as statements made within this afternoon's press release. This call is being webcast live and 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. Jacqui Shea.
Jacqueline Shea: Good afternoon, and thank you for joining today's call. Today, I'm very pleased to share some important updates on the key progress we've made recently. First and foremost, we have achieved our primary objective for this year, which is completing the rolling submission of our BLA for INO-3107. This represents a milestone in our work to deliver on the promise of DNA medicine for the RRP community and is our first BLA submission, an important moment for Inovio as well. We are now focused on the next steps in the process of bringing 3107 to patients. First, we expect to receive file acceptance by the FDA by year-end, and we have requested a priority review of the BLA, which, if granted, would provide for a potential PDUFA date around mid-2026. Second, we are continuing to drive commercial efforts forward in preparation for a swift and efficient launch, if approved. Although we will be second to market, we continue to believe that INO-3107 has compelling advantages that could make it the preferred treatment by RRP patients and their health care providers. Based on its clinical results and tolerability to date and the simplicity of its patient-centric treatment regimen. As we work toward a potential launch date for our first commercial product, we're also advancing our next-generation DNA medicine candidates. I'm pleased to report that landmark proof-of-concept data on our DNA-encoded Monoclonal Antibody or DMAb technology was recently published in Nature Medicine. We are also preparing for an upcoming presentation of promising preclinical data from our DNA encoded protein or DPROT technology at the World Federation of Hemophilia Global Forum. Both of these programs leverage a key strength of our DNA medicine platform, the ability to drive sustained targeted protein production within the body. We believe our DMAb and DPROT technologies have immense potential to treat multiple diseases and I look forward to sharing more on our progress in the coming months. Now I'll turn it over to Mike for some additional details about our regulatory progress and next steps for 3107. Mike?
Michael Sumner: Thanks, Jacqui. This is indeed a pivotal moment for our RRP program and for Inovio. We completed the rolling submission of our BLA on October 30, submitting a strong application package that we believe clearly articulates the clinical efficacy of 3107 and demonstrates a tolerable safety profile in clinical trials to date. We submitted under the accelerated approval pathway and have requested a priority review. So we anticipate file acceptance by year-end. and if priority review is granted, a PDUFA date potentially mid next year. In the meantime, we are preparing for our pre-approval inspections for both in-house and external manufacturing sites. And you may remember that the FDA completed our clinical inspection in August this year. We are also working to finalize our confirmatory trial plans. We had previously aligned with the FDA on a design for a randomized placebo-controlled trial based on guidance indicating that a placebo control arm was required for an indication in patients who had two or more surgeries in the year prior to treatment. We now recognize that the landscape has changed following the recent full approval of Papzimeos including how the FDA might view data requirements to support product approvals. The agency has confirmed that we only need to have initiated the confirmatory trial and enrolled the patient prior to approval, which we believe is achievable based upon our progress to date. As you will recall, we are working with more than 20 U.S. academic sites and have made significant progress with site initiation activities, which should enable us to rapidly initiate our confirmatory trial and deliver results in a timely manner. We nevertheless want the opportunity to further discuss potential options for our confirmatory trial design with the agency and have submitted a request for a Type D meeting. With a potential approval approaching, I'd like to take a moment to highlight the strengths of our RRP program, strengths that have been foundational to our progress so far and that I believe have the potential to position 3107 as a paradigm-shifting treatment preferred by patients and their health care providers. First, we believe that there is a significant unmet need among the adult RRP patient community, even with an approved treatment on the market, and they deserve to have therapeutic options that work for them to reduce the number of surgeries needed to control their debilitating rare disease. Next, 3107 has a mechanism of action that elicited an antigen-specific T cell response that corresponded to a reduction in surgery in our Phase I/II trial. In fact, the majority of patients experienced fewer surgeries with most experiencing a 50% to 100% reduction compared to the year before treatment. That clinical benefit continued to improve for most patients in the second 12-month period post treatment without additional dosing. I also want to highlight that our innovative CELLECTRA administration technology is an integral part to the effectiveness of INO-3107, enabling the targeted localized delivery of a DNA immunotherapy and offering a simple, effective and well-tolerated treatment experience. Building on these foundational strengths, I think what really sets 3107 apart is its potential to address the biggest concern that RRP community has shared time and again. First and foremost, we know that RRP patients, every single surgery matters. As we shared at the European Society for Medical Oncology Congress recently, INO-3107 demonstrated continued clinical benefit with a persistent decline in the mean number of surgeries through year 2 post therapy. For patients, that means a substantially lower average number of surgeries per year, a 78% drop from baseline to year 2, meaning less exposure to the risks and costs of surgery. We also believe one of the key strengths of our DNA medicine platform is the ability to continue treatment beyond the initial treatment regimen, further enhancing the immune response as we have demonstrated with other HPV-targeted DNA medicines. We believe this provides an opportunity to consider a longer-term treatment strategy to potentially extend or further improve clinical response, which is important for a chronic often lifelong virally mediated disease. The RRP community has also been very clear in their goal to make surgery a last resort, not a first-line treatment. As I said earlier, that was top of mind when we set out to study 3107 and our treatment regimen stands in stark contrast to Precigen's recently approved product. In their clinical trial prior to the third and fourth doses, patients were scoped to identify any residual papilloma tissue. And if any was found, a surgery was performed to maintain what is referred to as minimal residual disease or MRD. This process is reflected in the dosage and administration section of the prescribing information. They report these surgeries are performed to mitigate the effect of the immunosuppressive papilloma microenvironment and maximize the chance of clinical benefit for their product. So what does this requirement for maintenance of MRD during the dosing window mean for patients? 83% of patients in their clinical study underwent at least one of these surgeries with 40% undergoing surgery at both time points. For the patients who later went on to have a complete response, 72% of patients or 13 out of 18 received surgery in the dosing window. These MRD surgeries during the dosing window were not counted against their efficacy endpoint as they only started counting surgeries following completion of dosing. In contrast, in our trial for 3107, we counted every surgery following the first day of treatment against our endpoint. We believe that every patient deserves a treatment that reduces the number of surgeries they face and that includes any surgeries that are part of a treatment regimen. That's just one of the core reasons we see so much potential for 3107 and believe it could become the product of choice for RRP patients and providers. With that, I'll turn it over to our Chief Commercial Officer, Steve Egge to provide an update on the commercial front. Steve? Thanks, Mike.
Steven Egge: I'd like to start with why we're confident that 3107 has the potential to become the product of choice in the RRP market. A key advantage for 3107 is a positively differentiated product profile that I believe will appeal to laryngologists and to their RRP patients who are looking for an effective, well-tolerated treatment that minimizes exposure to the risks and costs of surgery, including during the treatment window. And this belief is founded on market research. The physicians we've spoken to were most interested in the fact that the vast majority of patients saw a significant benefit of 50% to 100% reduction in surgeries from 3107. And for many of them, that benefit continued to improve over time. Physicians were similarly impressed with the tolerability data, which shows that 3107 was generally well tolerated, limiting the impact on patients' return to daily life. This is very important when considering the treatment protocol includes 4 doses over a relatively short period of time. And in terms of the treatment regimen itself, 3107 offers a more patient-centric approach that takes into account real concerns of both physicians and their RRP patients. It can be administered in the physician's office without an ultracold chain requirement. The device is simple to use. And as Mike noted, very importantly, there's no requirement for minimum residual disease surgeries during the treatment window. We believe and the market research supports that there are many laryngologists and RRP patients who, given a choice, don't want to risk additional surgeries as part of the treatment that is intended to provide relief from surgery. And finally, as Mike noted, 3107 has been studied in a broad population of RRP patients, specifically in patients with as few as two surgeries during the year prior to treatment. We believe it's important for patients to start treatment as soon as possible after diagnosis to avoid the risk of irreversible damage from repeated surgery. Of course, in addition to these strengths, we'll learn from the launch of Papzimeos, and we will plan to be a fast follower in a market that we believe will continue to have significant unmet need when we enter. Moving now to a few updates on launch preparations. We've continued on pace with our regulatory progress. Since our last quarterly report, we've made noted progress on both the market research and operational fronts. We've continued critical research with payers, developed our initial pricing strategy, commenced price optimization work and completed targeting segmentation and product positioning work supporting a positively differentiated product profile. We're preparing for commercialization. We're finalizing contracts with our specialty distributor, specialty pharmacy and patient hub partners, finalizing our go-to-market model and advancing the build-out of our commercial organization. I look forward to providing more updates on our progress next quarter as we further advance our commercial preparations. We're planning to get out of the gate quickly if approved and I'm excited about the opportunity to bring this much-needed treatment to the RRP community. With that, I'll turn it over to Peter for a financial update. Peter?
Peter Kies: Thanks, Steve. Today, I'd like to provide an overview of Inovio's financial results for the third quarter 2025 and provide a snapshot of the year so far. I am pleased to report that we have continued to align our resources to support the development of our lead candidate, INO-3107 and we will be focused on the critical needs ahead as we work towards a potential launch in mid-2026. As you can see here, we've continued to reduce our operating expenses over the past year. Operating expenses dropped from $27.3 million in the third quarter of 2024 to $21.2 million in the third quarter of 2025, a 22% decrease. When you look at the first 9 months of 2025, we reduced operating expenses by 25% compared to the same time period last year. Our net loss for the quarter increased to $45.5 million or $0.87 per share basic and dilutive, primarily driven by a $22.5 million noncash loss on fair value adjustments related to our warrant liabilities. As the fair value of the warrants fluctuate with our share price and other market inputs, this adjustment can result in significant variability in our reported net loss. However, the net loss from operations prior to other income and expense items for the third quarter of 2025 decreased 22% to $21.2 million from a loss from operations of $27.3 million in the third quarter of 2024. On a per share basis, both basic and dilutive, the loss from operations for the third quarter of 2025 dropped 58% to $0.41 per share from $0.97 per share for the third quarter of 2024. You can see similar reductions in our net loss from operations for the first 9 months of 2025 versus 2024 as we continue to conserve and direct our resources to support the 3107 program. We finished the quarter of 2025 with $50.8 million in cash, cash equivalents and short-term investments compared to $94.1 million as of December 31, 2024. We estimate our cash runway to take us into the second quarter of 2026. This projection includes a net operational cash burn estimate of approximately $22 million for the fourth quarter of 2025. These cash runway projections do not include any further capital raise activities that we may undertake. As a reminder, you can find our full financial statements in this afternoon's press release as well as in our quarterly report Form 10-Q filed with the SEC today. And with that, I'll turn it back over to Jacqui.
Jacqueline Shea: Thanks, Peter. While our primary focus continues to be on 3107 and a potential launch mid next year, we see immense opportunity across the rest of our pipeline as well. We're excited about the potential we see for INO-3112 for head and neck cancer and INO-5401 for glioblastoma as well as a potential cancer prevention treatment in people with BRCA mutations. And while we're currently focusing resources on 3107, we look forward to exploring opportunities to advance those programs. And as I mentioned during my opening comments, -- earlier in the clinical pipeline, proof-of-concept data on Inovio's DMAb technology was recently published in Nature Medicine. This study led by the Wistar Institute in collaboration with Inovio, AstraZeneca and clinical investigators at the Perelman School of Medicine at the University of Pennsylvania was the first clinical demonstration that monoclonal antibodies, which are complex proteins, can be durably and tolerably produced within the human body without generating antidrug antibodies. Our DPROT technology builds on this research and our promising preclinical work evaluating the potential to expand into vivo production of therapeutic proteins will be presented this week at the World Federation of Hemophilia Global Forum, including our first research on Factor VIII production. Our deep approach aims to address some of the shortcomings of conventional therapeutic protein replacement treatments, including gene therapy approaches. As we work to bring the first approved DNA medicine to the United States, we are actively looking for future partnerships and development opportunities to advance these and other promising candidates across our pipeline. I'd now like to open up the call to answer any questions you might have. Operator?
Operator: [Operator Instructions] And your first question comes from the line of Ted Tenthoff from Piper Sandler.
Edward Tenthoff: When it comes to Papzimeos, have you guys heard if they've officially launched yet? And I'm wondering how big of a deal do you think this head start that they have is, especially in a market where it's going to be a lot about education and educating physicians about new therapeutic options.
Jacqueline Shea: Thanks, Ted. Yes. So what we've heard from their public statements is that Papzimeos became available to order as of October 21. So Steve, do you want to talk about our expectations of being a fast follower and how we see our market entry?
Steven Egge: Sure. So we would expect when we look at rare disease analogies and in the time period kind of between when they're out and when we would expect to be approved in mid-'26, if the current time line holds, we would expect single-digit penetration into the prevalent population in that time period. So at the time we enter, the majority of the prevalent population will be available. Obviously, the incident annual diagnosed patients will be available. And then over time, we've talked about, we would expect continued treatment or redosing also to represent an opportunity. So by the time we arrive, the vast majority of the opportunity will remain. And like we've talked about previously, we do expect to have the preferred product profile in this space. So over time, we think there's still a significant opportunity, of course, for 3107.
Operator: And your next question comes from the line of Jay Olson from Oppenheimer.
Jay Olson: Congrats on the progress. Our first question is, do you expect to have a similar label for 3107 versus Papzymeos? And do you think the requirement for debulking with Papzymeos is something that could present a key differentiator in the label for 3107? And then our second follow-up question is related to -- I think you mentioned you're still planning to run a pivotal study for full FDA approval. Is that study also required for ex U.S. approval?
Jacqueline Shea: Thanks, Jake. Great question. So Mike, maybe I can ask you to take the label question, first of all.
Michael Sumner: Yes, certainly. So I mean, from a patient population perspective, we studied a broad population. We had 2 to 8 surgeries pretreatment with INO-3107. And we demonstrated clinical efficacy across the entire range of surgeries. As you are aware, we have a well-tolerated product profile. So we do believe our data would justify a broad label similar to what Papzimeos received.
Jacqueline Shea: So in terms of the minimal residual disease surgeries that Precigen's treatment regimen requires, we do think that, that's going to be a really key differentiator. What we're hearing from our market research is Physicians have questions around the logistics of scheduling those surgeries, so do payers as well. So we think in addition to what it means for patients, patients clearly don't want to undergo additional surgeries as part of the treatment regimen. But just from the logistical point of view as well, it also creates some challenges. Steve, Mike, I don't know if you'd like to add to that.
Michael Sumner: No, I think you've covered it. That's good.
Jacqueline Shea: And then in terms of the confirmatory trial, Mike?
Michael Sumner: Yes. So I mean, obviously, you heard me say today that we have submitted a Type D meeting request to the agency to align on what that confirmatory study is going to look like. It's difficult to say exactly the value of that study to a European filing without knowing the exact design. But clearly, any data collected under -- in a rigorous manner is going to help define our efficacy and safety profile. So I think any study that we perform will be of value to our European filing.
Operator: And your next question comes from the line of Sudan Loganathan from Stephens.
Felix Ampomah: Congrats on the quarter. This is Felix Ampomah for Sudan. I have 1 or 2 questions. Number one, can you please comment on the sales force preparedness post 3107 approval? And then secondly, if 3107 is approved, given that it's a DNA-based medicine and also Papzimeos is virus-based, can you comment on switching from Papzimeos to 3107, if there wouldn't be any cross reactivity issues there?
Jacqueline Shea: Great questions, Felix. So maybe, Steve, you can take the commercial readiness question.
Steven Egge: Yes. So we're -- as I mentioned in the prepared comments, we're advancing our launch preparations. In terms of what a field force would look like, we are planning to have MSLs as well as an access team out ahead of approval to begin to engage in scientific exchange as well as work with payers on pre-approval information exchange. And then we haven't guided in terms of the timing on the sales force. You've probably heard Precigen has shared that they expect a sales team of 18 or 18 territories. And I think it's a safe assumption that we would be kind of in that neighborhood, but we haven't provided specific guidance there. But we're certainly advancing commercial plans and plan to get out of the gate very, very quickly post approval.
Jacqueline Shea: Mike, the cross-reactivity?
Michael Sumner: Yes, certainly. So there's certainly no reason to suspect there would be any cross-reactivity issues for patients who have previously received Papzimeos to receive INO-3107. The one thing we would anticipate, though, is it will be important to give the entire treatment regimen as clearly, we present different epitopes to patients. So they will need to have all 4 courses of the treatment.
Operator: And your next question comes from the line of Ram Selvaraju from H.C. Wainwright.
Eduardo Martinez-Montes: This is Eduardo on for Ram. I guess some questions related to the DMAb and the DPROT technologies. I was hoping if you could comment a bit on the levels of expression that you're achieving for the DMAb. I know that there was a SARS-CoV neutralizing antibodies that you guys published in Nature Medicine, as you mentioned. Curious about what kind of titers you guys are achieving and if that compares favorably to kind of existing recombinant kind of titers and doses and where you can -- how you're envisioning prioritizing programs within each of these technologies and platforms?
Jacqueline Shea: Yes. That's a really great question. So we're excited around our DMAb technology. In the Nature Medicine paper, we described production of 2 different monoclonal antibodies against SARS-CoV-2 within the body. We were able to get sustained expression over 72 weeks. We didn't see any antidrug antibodies being produced. And this was a dose escalation and safety study, and we were able to see a dose response with an increasing amount of the DNA medicine being administered and we were able to increase the dose by giving -- sorry, increase the amount of monoclonal antibodies that we were able to detect in the blood by giving a second dose. So we were able to demonstrate in this first clinical proof-of-concept study, a concentration in the blood of about of over 1 microgram per ml. And that would certainly put us into the right range for a number of different antibody therapies as well as potentially some protein replacement candidates as well. But this was the first proof-of-concept study. We were able to show that these monoclonal antibodies were functional as well and as functional as the native monoclonal that we designed this program around. So we think this is very promising and has read through to production of other proteins within the body. At the end of the day, monoclonal antibodies are a complex protein to produce and we think this data bodes extremely well.
Eduardo Martinez-Montes: Great. And any thoughts or comments on what specific programs you're going to potentially prioritize in further development down the line?
Jacqueline Shea: Yes. So we've -- this week, we're going to be presenting our first data on some of the preclinical work on some undisclosed targets that we've been conducting. And this first target that we're presenting on is Factor VIII for the treatment of hemophilia A. As we're progressing these programs, clearly, the majority of our resources are going towards 3107 at the moment supporting the potential launch of 3107. And so we're going to be looking to advance these programs once we get into the clinic through partnerships or once we have additional financial resources available.
Operator: And there are no further questions at this time. I will now hand the call back to Jacqui Shea for any closing remarks.
Jacqueline Shea: Thank you. Before we close, I'd like to reiterate the key catalysts ahead. We're now focused on the next milestones for 3107, which include expected BLA file acceptance by year-end and a potential PDUFA date in mid-2026. We'll also finalize our confirmatory trial design with FDA and have this study underway before approval. And we'll continue to advance our commercial preparations so that we'll be ready to launch our first commercial product in the year ahead. In closing, I'd like to take a moment to thank all the patients, advocates and doctors of the RRP community who have made our progress with 3107 possible. You are at the heart of our efforts to deliver on the promise of DNA medicine and our mission to provide every RRP patient with effective and durable relief from the devastating cycle of surgical interventions. As always, we're moving forward with the patient in mind, knowing that every day and every surgery matters. Thank you for your attention, and good evening, everyone.
Operator: And this concludes today's call. Thank you for participating. You may all disconnect.