Inovio Pharmaceuticals (NASDAQ:INO) reported first-quarter financial results on Wednesday. The transcript from the company’s first-quarter earnings call has been provided below.
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Access the full call at https://app.webinar.net/LJpjgyEg2Oa
Summary
Inovio Pharmaceuticals Inc reported a net loss of $19.7 million for Q1 2026, with operating expenses dropping by 13% compared to the previous year.
The company’s lead candidate, INO 3107, is under active FDA review with an anticipated PDUFA date of October 30, 2026, and is being considered for accelerated approval.
Inovio is advancing its commercial readiness plans for INO 3107, leveraging insights from the RRP community and preparing for a potential U.S. launch.
The company is collaborating with Akizo Inc. to evaluate INO 5412 for glioblastoma treatment, and is advancing its next-gen DNA medicine platform, including DProt technology for rare diseases.
Inovio strengthened its balance sheet with a $16 million public equity offering, projecting cash runway into Q1 2027, with a net cash burn of approximately $18 million for Q2 2026.
Full Transcript
OPERATOR
Good afternoon ladies and gentlemen and welcome to the Inovio Pharmaceuticals Inc 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 13, 2026. I would now like to turn the conference over to Jenny Wilson. Please go ahead.
Jenny Wilson (Moderator)
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. Jackie Shea, President and Chief Executive Officer, Dr. Mike Sumner, Chief Medical Officer Steve Egy, Chief Commercial Officer and Peter Keys, Chief Financial Officer. Today’s call will review our corporate and for the quarter ended March 31, 2026 as well as provide a general business update. Following prepared remarks we will conduct question and answer segment. During the call we will be making forward looking statements regarding future events and the future performance of the company. These statements relate to our business plans to develop Inovio Pharmaceuticals Inc’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 scheduled meeting with the FDA to discuss eligibility for the Accelerated Approval program. Our belief that INO 3107 fulfills the criteria for accelerated approval the potential benefits of INO3107, 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 INO3107 if approved and our engagement of commercial partners in preparation for a potential launch our collaboration with Akizo 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 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 Pharmaceuticals Inc’s President and CEO, Dr. Jackie Shea.
Dr. Jackie 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, INO3107 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
Dr. Jackie Shea
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
Dr. Jackie Shea
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 3107 on the regulatory front, we’ve been advancing our commercial readiness plans, including continuing to gather key strategic insights from the RRP community, and while the majority of our resources are focused on 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 Akizo and the Dana Fabra 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 8 production in hemophilia A and announced two new rare disease targets in fabri disease and hypophosphatasia for the platform.
Dr. Jackie Shea
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 3107.
Mike Sumner (Chief Medical Officer)
Mike thanks Jackie. As Jackie noted, since our BLA for INO 3107 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.
Mike Sumner (Chief Medical Officer)
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 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 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 3107 meets both of these criteria based on three factors. First, effectiveness as demonstrated in our phase 12 trial where the vast majority of patients experienced a 50 to 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 and third, a differentiated mechanism of action that does not come with the risk of reduced clinical effectiveness due to known immune factors that impact the efficacy of the approved product, including pre existing neutralizing antibodies or an immunosuppressive tumour 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 3107’s eligibility for accelerated approval are the patients, patients who face the risk of permanent damage to the vocal cords and significant social, …
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