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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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
Jenny Wilson (Moderator)
Dr. Jackie Shea
Dr. Jackie Shea
Dr. Jackie Shea
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)
Steve Egy (Chief Commercial Officer)
Dr. Jackie Shea
Peter Keyes (Chief Financial Officer)
Dr. Jackie Shea
Thanks, Peter. I'd now like to pause to open up the call to answer any questions you might have. Operator.
OPERATOR
Ted
Great. Thank you very much for taking the question. I really appreciate it and it sounds like things are going well with the review. I saw the Pepcinios numbers of 22, 21.6, which looks pretty good. Any comments? Can you expand a little more about how you expect to launch and differentiate versus the currently marketed product?
Steve Egy (Chief Commercial Officer)
Dr. Jackie Shea
Mike Sumner (Chief Medical Officer)
Jay
Thank you. Your next question comes from Jay with Oppenheimer. Please go ahead. Oh, 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 3107 and remind us any additional data or evidence that, that you have submitted or will submit. And then I had a follow up, if I could, please.
Dr. Jackie Shea
Mike Sumner (Chief Medical Officer)
Jay
Great, that's super helpful, thank you. And 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 you expect to receive from the fda?
Mike Sumner (Chief Medical Officer)
Yeah, great question, Jay. I mean we expect 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. So 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.
Jay
Okay, great. We'll look forward to that. Thanks for taking the questions.
Mike Sumner (Chief Medical Officer)
My pleasure.
Sudan
Mike Sumner (Chief Medical Officer)
Sudan
Great. And secondly, just wanted to ask also, how have your interactions with the RRP foundation been recently as you near your PDUFA data admits? Also the papcemios 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 Papademios I think currently has only penetrated about 25% to date?
Dr. Jackie Shea
Sudan
Saddam. Any follow ups? All good. Thank you so much. I appreciate the details.
Ying
Thank you. Your next question comes from Ying with H.C. wainwright. Please go ahead.
Yanzi
Thank you for taking my question. This is Yanzi 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 ino3107?
Dr. Jackie Shea
Yanzi
Thank you. And my second question is about when INO 3107 gets approval. So once that happens, what would be your marketing strategy or approach to seize market shares from Bev Zumios?
Dr. Jackie Shea
Yi Chen
Yi Chen, any follow up? Oh, thank you. Your last question comes from Liang Chen with Jeffries. Please go ahead.
Liang Cheng
Hey, this is Liang Cheng for Rajaston. Thank you for taking our questions, I guess, from us. How. How should we think about the potential label at approval, particularly the eligible patient population and anticipated restrictions versus the Phase 12 population?
Dr. Jackie Shea
Liang Cheng
And at a higher level, how are you thinking about pricing relative to precision?
Dr. Jackie Shea
Yeah, so we're thinking of rare disease pricing. Clearly, in our peer research that we've conducted, pears recognize that rare disease pricing is appropriate for this indication. We'll be conducting some price optimization research. And. And we'll be commenting on pricing a bit closer to launch. Got it. Thank you.
OPERATOR
Thank you. There are no further questions at this time. I will turn the call back over to Jackie Shea.
Dr. Jackie Shea
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