Prepared remarks
Good afternoon, ladies and gentlemen, and welcome to the Inovio Second Quarter 2026 Financial Results Conference Call. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press 0 for the operator. This call is being recorded on Wednesday, 08/12/2026. I would now like to turn the conference over to Jennie Willson, Director of Communications. Please go ahead.
Thank you. Good afternoon, and thank you for joining the Inovio Second Quarter 2026 Financial Results Conference Call. Joining me today are Dr. Jacqueline E. Shea, President and Chief Executive Officer, Dr. 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 06/30/2026 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 10/30/2026 PDUFA date and our recently completed informal meeting with the FDA; our belief that INO-3107 fulfills the criteria for accelerated approval; the potential benefits of INO-3107, including our belief that it has a positively differentiated product profile; our belief regarding its competitive advantages relative to existing treatments, including PAPZIMEOS, and the potential to become the preferred product and new standard of care for patients and their physicians if approved; our expectation to receive orphan drug market exclusivity for INO-3107 if approved; the anticipated timing of label negotiations; the anticipated commercial launch of INO-3107 if approved; our commercial launch infrastructure and preparations; our engagement of commercial partners, including Syneos Health and other third-party partners in preparation for a potential launch; the recent positive Phase III data announced by our partners in Greater China for VGX-3100 as a potential treatment for cervical dysplasia and ApolloBio plans to seek regulatory approval for VGX-3100 in China based on that data; the advancement of our DPROT technology platform; capital resources, including our estimated operational net cash burn of $18 million for the third quarter of 2026 and the expected sufficiency of our cash resources into late first quarter 2027, and through a potential launch of INO-3107; and 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. Jackie Shea.
Good afternoon. And thank you to everyone for joining today's call. Since our last quarterly call in May, the FDA's review of our BLA for INO-3107 has continued to advance, with several important steps in the regulatory process now complete. We are on track for the October 30 target PDUFA date. While Mike will go into greater detail on our regulatory progress, the highlights are that the FDA has completed its late cycle review meeting and completed all of the scheduled prelicensure inspections. The FDA also granted the previously requested informal meeting where we had the opportunity to present the totality of data supporting INO-3107's safety and efficacy and its highly differentiated approach in treating recurrent respiratory papillomatosis, RRP, a chronic HPV-related disease that has a devastating impact upon patients. We believe there remains significant unmet need for treatment options that reduce the need for RRP-related surgery, and we believe the efficacy, tolerability, and patient-centric approach of INO-3107 could enable it to become established as the new standard of care. With that goal in mind, we have continued advancing our commercial launch preparations, including initiating the build of our critical launch infrastructure, which Steven will expand upon. We also completed an equity offering that provided $18.3 million in net proceeds in late July to support these efforts, which we expect to extend our runway into late first quarter 2027 and through a potential launch of INO-3107 if approved. While our resources are focused on advancing INO-3107, Inovio's partnerships have enabled important progress with other promising candidates across our pipeline. ApolloBio, our partner for VGX-3100 in Greater China, announced positive topline results from its pivotal Phase III trial as a potential treatment for HPV 16 or 18-positive cervical dysplasia. This further highlights the potential of Inovio's DNA medicine platform as a non-surgical treatment option for HPV-related diseases. Inovio also presented promising preclinical data on our next-generation DNA-encoded protein, or DPROT, technology targeting Factor VIII production for the treatment of hemophilia A at several scientific conferences during the second quarter. Of note, we have added two new rare disease targets for the platform, Fabry disease and hypophosphatasia. I will now turn it over to Mike for some additional details on our regulatory progress with INO-3107.
Thanks, Jackie. As Jackie noted, over the past several months, we have made considerable progress with INO-3107 on the regulatory front. As the FDA's review of the BLA continues to advance under the agency's accelerated approval program, the FDA has now completed its late cycle review meeting and all scheduled prelicensure inspections, which included clinical, drug manufacturing, in-house drug testing, and our delivery device facility. I am pleased to say that there was only one reported observation from the inspections, which we believe we have appropriately addressed, and we are in the process of submitting our response to the FDA. Following the recent change of leadership at CBER and the Office of Therapeutic Products, the FDA also held our clinical informal meeting in July. During this meeting, we had the opportunity to present the totality of data supporting the safety and efficacy of INO-3107 and highlight its highly differentiated approach in treating RRP. We continue to believe we have provided a strong rationale for eligibility under the accelerated approval program, highlighting the ongoing need in the RRP community for therapeutic alternatives to existing treatments, while also sharing our rationale for how INO-3107 demonstrates a meaningful therapeutic benefit over those existing treatments. During this informal meeting, the FDA noted that the December 2025 final acceptance letter. They did, however, indicate that their feedback on the design of our confirmatory trial will be forthcoming. To provide more context around INO-3107's eligibility for accelerated approval, when there is already an existing product that has received a full approval, the FDA's guidance indicates that a product candidate reviewed under the accelerated approval program should provide both a meaningful therapeutic benefit over existing treatments and meet a remaining critical unmet need among patients. We believe that INO-3107 meets both of those criteria based on three factors. First, clinical efficacy as demonstrated in our Phase I/II trial where the vast majority of patients experienced a 50% to 100% reduction in surgery in year 1, with continued clinical improvement in year 2. Second, INO-3107 has been shown in clinical studies to be well tolerated, potentially offering a beneficial safety profile that does not include the requirement for scoping and surgery during the dosing window to maintain minimal residual disease, or MRD, which is required for PAPZIMEOS and included in their labeling. Third, INO-3107 has a differentiated mechanism of action not impacted by preexisting neutralizing antibodies or an immunosuppressive tumor microenvironment, both of which may impact the efficacy of PAPZIMEOS. These three key strengths—clinical efficacy, safety, and a differentiated mechanism of action—underpin why we believe INO-3107 is eligible for review under the accelerated approval program and has the potential to become the new standard of care for RRP. Importantly, a representative from the RRP Foundation and a healthcare provider specializing in the treatment of RRP were able to join the informal meeting as well. Both provided statements reiterating the significant continuing unmet need in the RRP community and their belief in the ability of INO-3107 to meet those needs. From the start of our development work on a treatment for RRP, we have been working closely with the foundation, patients, and other RRP experts to understand and highlight what matters most to them—providing every patient with relief from the risks and costs that come with every surgery. We are thankful for their continued support as we work to deliver on the promise of INO-3107 for patients. We believe we are now in the final stages of the regulatory review process and anticipate starting label negotiations in September. It is also important to note here that if approved, we would expect to receive seven years of orphan drug market exclusivity for INO-3107 based on our differentiated delivery and mechanism of action. Finally, we are also initiating our medical science liaison team to begin scientific engagement with potential customers. With that, I will now turn it over to Steven to provide an update on our commercial progress and strategy.
Thanks, Mike. We are excited about the opportunity to bring INO-3107 to patients who are waiting for new treatment options. We see a significant unmet need in the market for alternatives to surgery, and certainly, the early uptake of PAPZIMEOS validates this unmet need. The early reported uptake is encouraging, with approximately 200 patients treated. This still only represents low single-digit penetration among a prevalent population, so the vast majority of RRP patients in this market are still open for a new treatment option. INO-3107 is a product that was designed to deliver what we believe patients and healthcare providers want most: clinical efficacy, tolerability, and a simple patient-centric treatment approach that reduces the need for surgery. As you can see on this slide, INO-3107 offers many competitive advantages. First, INO-3107 treats RRP without requiring additional scoping and surgeries during the dosing window. In the dosing section of the prescribing information for PAPZIMEOS, scoping and surgeries to remove any papilloma are required prior to doses 3 and 4. In the Phase I/II trial for PAPZIMEOS, the vast majority (83%) of participants required at least one MRD surgery during the dosing window. When given a choice, we believe patients would prefer a therapeutic option that does not require additional surgery, as every surgery comes with a risk and a cost to patients. An additional advantage of not requiring surgery during the dosing window is that this also helps minimize any recovery days needed during treatment. As Mike noted, with INO-3107, there is no potential impact on clinical benefit from an immunosuppressive papilloma microenvironment and no potential impact on clinical benefit due to preexisting neutralizing antibodies. And finally, INO-3107 does not require specialized ultra-cold chain handling, so there is more flexibility in terms of care settings where the product can be administered. These competitive advantages are foundational to our belief that INO-3107 has the potential to become the new standard of care for RRP, should it be approved. To execute on this opportunity, we plan to leverage experienced field teams, and we are pleased to share that Syneos Health, which has deep experience in rare disease launches, will serve as Inovio's contract sales organization to support commercialization in the U.S. We also plan to execute targeted marketing in partnership with our agency of record and establish a strong patient support team with our hub partner. Together, these efforts will enable us to establish access with payers and hospital systems, drive preference with healthcare providers and patients, and over time grow the market by educating patients and caregivers. We are now ready to move to the implementation phase of our launch planning. There is important work ahead, and it will continue to be driven by the needs of our RRP patients and the opportunities we see for INO-3107 to meet those needs. I will now turn it back over to Jackie for a pipeline update.
Thanks, Steven. All our resources are focused primarily on INO-3107. We have continued to look to partnerships to help advance other promising candidates in our pipeline. Collaborations will continue to be essential to the growth and evolution of our platform. An example of this is the partnership with ApolloBio I mentioned earlier. They recently announced positive topline results from their pivotal Phase III trial of VGX-3100 for the treatment of cervical dysplasia patients. The trial successfully met its predefined primary efficacy endpoint of CIN 2 or CIN 3 lesion regression and HPV 16 and 18 viral clearance and demonstrated an overall favorable safety and tolerability profile. ApolloBio plans to use the results from the study to support a future filing for regulatory approval for VGX-3100 in China. Furthermore, the positive data from this trial provide additional support for the potential of DNA medicine to treat related diseases and eliminate and/or reduce the need for surgical interventions to control the potentially devastating implications caused by HPV infection. We are also working to build and accelerate the development of our next-generation DNA medicine platform. During the second quarter, we shared exciting research on our DNA-encoded protein, or DPROT, technology targeting Factor VIII for hemophilia A at several scientific conferences, including the American Society of Gene and Cell Therapy Annual Meeting and the World Orphan Drug Congress. Based on this promising research, we are looking to form partnerships to advance DPROT candidates in various rare diseases, including Fabry disease and hypophosphatasia, and have ongoing discussions with a number of potential partners. Now I will turn it over to our CFO, Peter D. Kies, for a financial update. Peter?
Yes. Thanks, Jackie. Today, I would like to provide an overview of Inovio's financial results for the second quarter of 2026. As Jackie noted, our primary goal is to advance INO-3107 towards approval and to enable an efficient launch, if approved. We are now entering an important phase of the build-out of critical commercial work streams requiring additional resources. To that end, I am pleased to report that the company strengthened its balance sheet with an underwritten public offering in July 2026. Net proceeds from the offering after deducting underwriter discounts, commissions, and offering expenses were $18.3 million. We ended the second quarter of 2026 with $36.7 million in cash, cash equivalents, and short-term investments compared to $58.5 million as of 12/31/2025. With the addition of the July public offering, we expect to extend our estimated cash runway into late first quarter 2027 and through a potential launch of INO-3107. This projection includes an operational net cash burn estimate of $18 million for the third quarter of 2026. These cash runway projections do not include any further capital raising activities that we may undertake and are based on current projections and assumptions. We will continue to be mindful of our cash burn while ensuring we are ready to launch INO-3107 if approved. Turning to our operating results for the second quarter, operating expenses dropped from $23.1 million in the second quarter of 2025 to $18.6 million in the second quarter of 2026, a 19% decrease. When you look at the first six months of 2026, we reduced operating expenses by 16% compared to the same period last year. Again, this is due to ongoing strategic efforts to manage our resources to support progression of the INO-3107 program. Inovio's net loss for the second quarter was $6.0 million, or $0.07 per share basic and diluted, compared to a net loss of $23.5 million, or $0.61 per share basic and diluted, for the second quarter of 2025. The decrease in net loss was primarily driven by a $13.9 million noncash gain on fair value adjustment related to our warrant liabilities for the three months ended 06/30/2026. As the fair value of the warrants fluctuates with our share price and other market inputs, this adjustment can result in significant variability in our reported net loss. 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.
Thanks, Peter. I would now like to open up the call to answer any questions you might have. Operator?
Questions and answers
Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press star followed by the number 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 number 2. If you are using a speaker phone, please lift the handset. One moment please for your first question. Your first question comes from the line of Liang Chan from Jefferies.
I guess for me, I wonder could you provide more detail on the INO-3107 informal clinical meeting and whether any new efficacy, safety, or CMC-related questions were briefed by the FDA?
Hi, Liang. Nice to hear from you. Mike, do you want to provide a bit more detail on that informal clinical meeting?
Yeah. Happy to. We were delighted that the FDA granted the meeting as it really gave us an opportunity to share with them the entirety of our compelling dataset as it relates to the efficacy and safety of INO-3107. During the review process, we have had the opportunity to submit the assessment back in February and respond to some clinical questions, so the FDA had seen the entirety of the data that we submitted to them, and we really did not get into too much discussion around that. They certainly have not disagreed with our positioning in terms of how we have presented our efficacy and safety data. But, unfortunately, as you heard me say, they were not in a position to comment on the eligibility question as the file is under active review.
Okay. And could you provide any updates on the confirmatory trial design, including the patient population, endpoints, and the potential initiation following approval?
Yes. So we are still awaiting the FDA's comments on our submitted protocol to the IND. They did say during that informal meeting that comments would be forthcoming. This is relatively late in the review process now, so we obviously will be discussing with them their expectations around starting that trial, but we have no reason to believe that getting that trial up and running will impact our approvability or our PDUFA date. Thank you.
As a reminder, if you have any questions or follow-up, please press *. There are no further questions at this time. Oh, we do have one question coming from Yi Chen from H.C. Wainwright. Please go ahead.
Hey. This is Katie on for Yi Chen. Should investors expect another capital raise before the PDUFA or is the plan to bridge launch through revenue and a financing partner?
Hi, Katie. Nice to hear from you. As we discussed on the call, we are currently funded through late first quarter 2027, which is after the anticipated launch. So we are currently funded through the projected launch date. Peter, do you want to comment further?
No, Jackie. I think you covered it. Thank you. Just as a quick follow-on, does that first quarter 2027 projection bake in prelaunch inventory build and launch marketing spend or does it assume a straight-to-launch scenario without those costs? No. Those are built in throughout fourth quarter and first quarter.
There are no further questions at this time. I will now turn the call over to Dr. Jacqueline E. Shea. Please continue.
Thank you. As we enter the critical final stages of the BLA review and prepare for a potential launch of INO-3107, we are focused on the important work ahead and excited about the potential we see to meet the unmet needs of the RRP community. We are grateful for the continued collaboration and support of the RRP Foundation, whose advocacy inspires our work every day. Together, we are driven by the understanding that every surgery matters, every patient matters, and every patient deserves a treatment that works for them. I look forward to sharing more on Inovio's progress in the pivotal months ahead. Thank you for your attention, and good evening, everyone.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.