Inovio Pharmaceuticals, Inc. (NASDAQ:INO) Q4 2022 Earnings Call Transcript

Michael Sumner: So I always feel bad because I can’t give too much information about this. The biomarker signature that we used as the primary biomarker to select the population was not the only biomarker that we looked at — so we will actually have more data in the database. But again, we haven’t disclosed that level of detail at the moment, I’m afraid.

Jacqueline Shea : I think what we can say though is we’re working with our partner, QIAGEN, to develop these biomarkers. And this data is very new. It’s very recent for us and we’re going to need to dig down into it and hopefully, come back to you with some further updates over the coming months.

Yi Chen : Got it. Did the FDA say that future trials have to use a biomarker?

Michael Sumner: I don’t believe they stipulated that. That was our decision after we saw the data from REVEAL 1 in terms of our proposal to them. I mean, what they did say that by switching to the biomarker population, it became a more exploratory study, and we would have had to do or we will have to do one or two more trials before we could file for a BLA in that investigator in the biomarker investigational population.

Yi Chen : Okay. Got it. And did the does the fact that the combined data set for both the biomarker selected population and the amortization population but sell the statistical significance. Does that mean I mean the biomarker really doesn’t add much to the final results?

Michael Sumner: I guess it depends what you mean by it doesn’t add much. But I mean, clearly, the efficacy rate in the biomarker-selected population in the combined group was, I believe, 54%. So I mean there was a significantly increased efficacy seen in that population. So I mean, there was clearly an indication of a predictive nature of that biomarker.

Operator: This concludes our question-and-answer session. I would like to turn the conference back over to Jacque Shea for any closing remarks.

Jacqueline Shea : Thank you for your questions and to everyone joining us today. To summarize, as you’ve heard on the call today, — in the past year, we’ve taken measured steps to prioritize our pipeline and focus our efforts on the programs with the highest probability of clinical and regulatory success and strongest commercial potential. These steps are underpinned by our commitment to operational excellence and financial discipline and our belief in the potential of DNA medicines to improve the lives of patients. We’re excited about our plans to advance our key programs, such as INO-3107 to the next stage of clinical development and look forward to providing you with updates on our progress in the coming quarters. With that, thank you again for your attention, and have a great evening, everyone.