Aspira Women’s Health Inc. (NASDAQ:AWH) Q4 2022 Earnings Call Transcript

Nicole Sandford: So we’ve mentioned in the past that we are pursuing a number of different potential paths for the launch of an endometriosis test which could include an FDA path or an LDT. So we’re not ruling either out at this point or remove them all in, I guess, I would say. So from a regulatory standpoint, that’s still sort of developing as we continue to think about what makes the most sense from a launch perspective. What needs to happen, as Ryan mentioned, the biggest barrier to a completed test is in remains, the availability of acceptable samples for the validation of the test. That has been a challenge and it continues to be a challenge. It doesn’t do us with any good whatsoever to try to validate or continue development with samples that are not high quality and that don’t line up exactly with the test that we’re developing.

So that is a challenge. So we continue to seek out additional sources and as we said in the remarks earlier, we were very pleased to see that we were able to identify a number of additional samples in our own biobank as we continue to refine the test and the requirements.

Operator: Our next question comes from the line of Andrew Brackmann with William Blair.

Griffin Soriano: This is Griffin, on for Andrew. Thank you taking our questions. Maybe just to start on OvaWatch, can you talk a little bit about the stock feedback that you’re getting on OvaWatch? Are you seeing an expanded ordering population that you have that expanded label? And then I think there was some expectation for some cannibalization of OVA1Plus, has that played out as sort of expected so far?

Nicole Sandford: Thanks for the question. I’ll say on the cannibalization side, we have not seen that. We’ve continued to see growth in OVA1Plus. We were really thoughtful about how we presented the test to the physicians and the intended each very, very clear. We’ve found that they’ve been able to understand very easily which test is appropriate given the intended use. So happy to say that has not materialized as of yet. Of course, it’s early days. And in terms of physician response, so far, it’s been overwhelmingly positive. As you know, it takes a while to get the word out on a new test. So we continue to go out in the field and also as a company, we’re investing in a lot of additional physician conferences and higher impact at the conferences were attending to get the word out.

But people seem to be really open to the intended use and they understand the value of taking what turns out is a pretty significant number of masses that sort of fall into the indeterminant category which frankly means they really don’t have a good sense of what to do with that patient; and it’s a large percentage. Having a tool that helps them to reduce that number or to just have better insight into that number of patients is incredibly valuable. We’ve heard that time and again. So as they’ve learned how the test works and the value of being able to isolate the patients that really do need additional scrutiny or additional clinical intervention and rule out to some extent, the women that are in that indeterminate category has been very, very valuable.

Griffin Soriano: Okay. And that corporate deck, I think, has a potential of watches $300 million to $420 million. Obviously, serial monitoring is really a big part of that. Can you just go in a little bit more detail on the time line for the serial launch indication? I know you talked about a prospective study that’s enrolling but any sense of time lines for launch there?