Natera, Inc. (NASDAQ:NTRA) Q3 2023 Earnings Call Transcript

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And if we do move the ball forward the — I think, the next steps would really be in 2025 in 2026, where we’ll be operating in a different environment where we think we’ll be cash flow positive.

Dan Brennan: Got it. Thanks a lot. And then maybe just another one on NTCN, just if you are successful getting, an inclusion maybe as a footnote in the current update that you expect early next year like what would that what does that mean? Obviously commercial coverage could start and you’d likely I guess see a volume benefit to maybe just clarify. And then as a related question, obviously, the GALAXY 24-month data and the MRD-positive arm looked really impressive. How much does that derisk ALTAIR? I know you kind of mentioned — but I think the regimen might be a little bit different ALTAIR. Just wondering how much of confidence that gives you in ALTAIR positive readout. Thank you.

Steve Chapman: Yes. Let me just talk quickly about guidelines and then I’ll have Alex comment on the CIRCULATE data. So the — why do you — you need guidelines to grow volume and to get commercial reimbursement. And we’re growing volume right now at a really fast pace. And we’re also now seeing commercial reimbursement coming on, and because of the biomarker bill, we think that’s going to continue. So at this point, it’s — I think guidelines obviously would quicken the pace of those things. But, we’re going to get really far along here without guidelines coming in. And I think importantly for Natera, we don’t need guidelines to achieve cash flow breakeven and continue to significantly grow the business. So we’ll wait and see what happens — but if we don’t end up getting it this time around we have the ALTAIR study coming out and we’ll be in a great position. So Alex, do you want to comment on the CIRCULATE data whether that’s derisked ALTAIR Vega.

Alexey Aleshin: Yes, absolutely Steve. So we definitely have seen continuation of separation of the curves in the CT positive arm in the CIRCULATE study. And furthermore, we’ve seen that in the CT negative arm, we continue to see very little if any benefit from adjuvant chemotherapy. And that absolute difference has shrunken and actually we’ve seen those curves now reverse. We think actually both of those help derisk not just the ALTAIR study but also the Vega study. And since ALTAIR is coming up just around the corner, I think the way we are extrapolating these findings is that CT positive patients have almost 100% risk of recurrence without treatment. We’ve seen that adjuvant chemotherapy helps reduce that risk but does not eliminate that.

And the way that healthcare is designed, we are adding a known active agent TAS-102 that’s already approved in colorectal cancer and is none to have efficacy even in the second and third-line setting. So by adding that and randomizing patients to either get that drug or get placebo, we are pretty confident that there will be an effect that should be able to bear out from that study. Again, we won’t know the results until the study is unblinded. But I think given the study design, given the findings so far from the CIRCULATE data, we’re very positive. But we should be able to see something if the effect is there.

Dan Brennan: Great. Thank you.

Operator: This does conclude the allotted time that we have for question and answers. I will now hand the call back over to our presenters for any closing remarks.

Michael Brophy: Hey, thanks operator, and thanks to everyone for joining us today. We’re really excited about these results, and we’re very pleased to share with you. So, thanks again for joining.

Operator: This concludes today’s call. Thank you for joining. You may now disconnect your lines.

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