Inovio Pharmaceuticals, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Inovio Second Quarter 2026 Financial Assaults Conference Call. At this time, all lines are in a 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, August 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 Adnopio Second Quarter 2026 Financial Results Conference Call. Joining me today are Dr. Jackie Shea, President and Chief Executive Officer, Dr. Mike Sumner, Chief Medical Officer, Steve Ege, Chief Commercial Officer, and Peter Kies, Chief Financial Officer. Today's call will review our corporate and financial information for the quarter ended June 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 Thank you for joining us today. Our belief regarding its competitive advantages relative to existing treatments, including Pepsimios, 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, and the anticipated timing of label negotiations. The anticipated commercial launch of INO 3107, if approved. Our commercial launch infrastructure and preparations. are engagement of commercial partners including Cineos Health and other third-party partners in preparation for a potential launch. The recent positive phase 3 data announced by our partners for Greater China for VGX3100 as a potential treatment for cervical dysplasia and ApolloBio plans to seek regulatory approval for VGX3100 in China based on that data. The advancement of our DProt technology platform, capital resources, including our estimated operational net cash burn of approximately $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. 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 IMO 3107 has continued to advance, with several important steps in the regulatory process now complete. We are on track for the October 30th target PDUFA date, and 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 pre-license year inspections. The FDA also granted the previously requested informal clinical meeting where we had the opportunity to present the totality of data supporting INO3107's safety and efficacy and highly differentiated approach in treating 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 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 Steve will expand upon. We also completed an equity offering that provided approximately $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 3107 if approved. While our resources are focused on advancing 3107, Inovio's partnerships have enabled important progress with other promising candidates across our pipeline. Apollo Bio, our partner for BGX 3100 in Greater China, announced positive top-line results from its pivotal Phase 3 trials, as the 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 pre-clinical data on our next-generation DNA-encoded protein or DPOP technologies, targeting Factor VIII production, for the treatment of haemophilia ray at several scientific conferences during the second quarter. Of note, we have added two new rare disease targets for the platform, Fabry disease and hyperphosphatasia. I'll now turn it over to Mike for some additional details on our regulatory progress with 3107. Thanks, Jackie.

As Jackie noted, over the past several months we have made considerable progress with INO3107 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 pre-licensure inspections, which included clinical, drug manufacturing, in-house drug testing, and our delivery device facility. I'm 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 Ciba 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 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 3107 demonstrates a meaningful therapeutic benefit over those existing treatments. During this informal meeting, the FDA noted that the BLA review was ongoing and did not discuss their preliminary conclusion regarding accelerated approval eligibility, which was noted as a potential review issue in the December 2025 file acceptance letter. They did, however, indicate that their feedback on the design of our confirmatory trial will be forthcoming. To provide more context around 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 3107 meets both of those criteria based on three factors. First, clinical efficacy 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 with continued clinical improvement in Year 2. Second, 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 pap semios and included in their labeling. Third, 3107 has a differentiated mechanism of action. These three key strengths, clinical efficacy, safety, and a differentiated MOA, underpin why we believe 3107 is eligible for review under the Accelerated Approval Program. Thank you for joining us today. 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 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 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 Steve to provide an update on our commercial progress and strategy. Steve?

Thanks, Mike. We're excited about the opportunity to bring 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 Papsimeos validates this unmet need. Thank you for joining us. and a simple patient-centric treatment approach that reduces the need for surgery. As you can see on this slide, 3107 offers many competitive advantages. First, 3107 treats RRP without requiring additional scoping and surgeries during the dosing window. In the dosing section of the prescribing information for papzimios, scoping and surgeries to remove any papilloma are required prior to dose 3 and 4. In the Phase 1-2 trial for Pepsimios, 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 at 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 3107, there's 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, 3107 does not require specialized ultra-cold chain handling, so there's more flexibility in terms of care settings where the product can be administered. These competitive advantages are foundational to our belief that 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're pleased to share that Cineos Health, who has deep experience in rare disease launches, will serve as an OVO'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 for 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're now ready to move to the implementation phase of our launch planning. There's important work ahead and it will continue to be driven by the needs of our RP patients and the opportunities we see for 3107 to meet those needs. I'll now turn it back over to Jackie for a pipeline update. Jackie?

Thanks, Steve. All our resources are focused primarily on 3107. We continue 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 Apollo Bio I mentioned earlier. They recently announced positive top-line results from their pivotal Phase 3 trial of EGX3100 for the treatment of cervical dysplasia patients. The trial successfully met its predefined primary efficacy endpoint of SYN2 or SYN3 lesion regression and HPV16 and 18 viral clearance. and demonstrate an overall favorable safety and tolerability profile. Apollo Bio plans to use the results from the study to support a future filing for regulatory approval for BGX 3100 in China. Furthermore, the positive data from this trial provide additional support for the potential of DNA medicine to treat HPV-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 partnerships to accelerate the development of our next-generation DNA medicine platform. During the second quarter, we shared exciting research on our DNA-encoded protein, or D-PROC technology, targeting Factor VIII per Haemophilia 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 DPOP candidates in various rare diseases, including Fabry disease and hypophosphatasia, and have ongoing discussions with a number of potential partners. Now I'll turn it over to our CFO, Peter Kies, for a financial update. Peter?

Hello?

Hello? Here, go ahead. Yes. Thanks, Jackie. Today I'd 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're now entering an important phase of the build-out of critical commercial work streams requiring additional resources. To that end, I'm 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 operating expenses were approximately $18.3 million. We ended the second quarter of 2026 with a $36.7 million in cash, cash equivalents, and short-term investments, compared to $58.5 million as of December 31, 2025. With the addition of the 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 approximately $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 estimates while ensuring we are ready to launch 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 was due to ongoing strategic efforts to manage our resources to support progression of the 3107 program. Inovio's net loss for the second quarter was $6 million, or $0.07 per share, basic and dilutive, compared to a net loss of $23.5 million, or $0.61 per share, basic and dilutive, for the second quarter of 2025. The decrease in net loss was primarily driven by a $13.9 million non-cash gain on fair value adjustment related to our warrant liabilities for the three months ended June 30, 2026. As the fair value of the warrants fluctuates with our share price and other market inputs, this adjustment can result in a 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 10Q filed with the FCC. And with that, I'll turn it back over to Jackie.

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. Should you have a question, please press star followed by the number one on your touchtone 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 two. If you are using a speakerphone, please lift the handset. One moment please for your first question. The first question comes from the line of Lian Chan from Jefferies. Please go ahead.

Good afternoon. I guess for me, I wonder, could you provide more detail on 30107, informal clinical meeting and whether any new efficacy safety or CMC-related questions were raised by FDA? Okay.

Eileen Chen, nice to hear from you. Mike, do you want to provide a bit more detail on that informal clinical meeting?

Yeah, happy to. I mean, we were delighted that FDA granted the meeting as it really gave us an opportunity to share with them the entirety of our compelling data set as it relates to the efficacy and safety of 3107. I mean, during the review process, we've had the opportunity to submit the Assessment Aid back in February and obviously respond to some clinical questions. So the FDA had seen the entirety of the data that we submitted to them, and we really didn't get into too much discussion around that. They certainly have not disagreed with our positioning in terms of how we've presented our efficacy and safety data. But unfortunately, as you heard me say, they weren't 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 endpoint and potential initiation following approval?

Yes, so we are still awaiting the FDA's comments on our submitted protocol to the IMD. They did say during that informal meeting that comments would be forthcoming. Obviously, 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 As a reminder, if you have any questions or follow-up, please press star 1.

There are no further questions at this time. Oh, we do have one question coming from Yi Chen from FC Wainwright. Please go ahead.

Hey, this is Katie on for you. Should investors expect another capital raise before the PDUFA or is the plan to bridge launch through revenue and financing partner?

Hi, Katie. Nice to hear from you. Hi. So, as we... As we discussed on the call, we're currently funded through late first quarter 2027, which is after the anticipated launch. So we're currently funded through 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 27 baked 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.

Perfect. Thank you.

There are no further questions at this time. I will now turn the call over to Dr. Jackie Shea. Please continue.

Thank you. As we enter the critical final stages of the BLA review and prepare for a potential launch of INO3107, 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 and 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.