Keros Therapeutics Inc to Host Conference Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Kripa Devarakonda - Truist Securities, Inc. - Analyst : Hey, guys. Thank you so much for taking my question and congrats on all the progress. I have a question for Dr. Gomberg on the effect on erythropoiesis. This could be potentially a key differentiator versus the sotatercept. Having seen data from sotatercept, how big of a challenge do you think that sotatercept could impact on hemoglobin is? And also, on the other differentiator that has impact on BMP sparing and effect on telangiectasias. Based on the biomarker data that you've seen so far, what is the level of confidence you have that KER-012 can have an impact on vascular integrity or not have an impact? Thank you. Mardi Gomberg - George Washington University, School of Medicine Health Sciences - Chief Clinical Research Officer & Director of the Pulmonary Hypertension Program Thank you so much for that question. I think that what is clear from the data in the preclinical study is that KER-012 did not have any effect on the recent [hypothesis] and has limited sparing of the BMPs in general, including the BMP-9. So we can only hypothesize but it is favorable that we didn't see any issues in our healthy volunteer study. So whether or not that happens in clinical Phase 2, this is why we're doing the trial. We're hopeful that we won't see it, but time will tell.

Question: Tyler Van Buren - TD Cowen - Analyst : Hey, guys. Good morning. Thanks very much for the presentation. A couple for you, Dr. Gomberg, I appreciate your thoughts. So clearly, patients were dosed aggressively on the STELLAR trial to push efficacy higher that led to an increased telangiectasias and bleeding events that you referred REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. to. At six months, which was at the same level that was observed to eight months previously in [Pulsar]. So what is your level of concern related to these events and their ability to increase over time? That's the first question. And then the second one is just related to the ability to push efficacy higher. If 012 is able to push the dose significantly higher than sotatercept, do you believe we will see better efficacy in patients? Mardi Gomberg - George Washington University, School of Medicine Health Sciences - Chief Clinical Research Officer & Director of the Pulmonary Hypertension Program So as I'm guessing, most of you know (technical difficulty) for the sotatercept database. And so what I can tell you is that based on the publication, there was an instant (technical difficulty) in telangiectasias. The dose is 0.7. I'm not sure that you could frame that we pushed it so that we could have more adverse events. But it's clear that we saw this happen. Whether or not Keros, because we don't have issues with the rest of (technical difficulty), whether or not we can actually have more targeting. I think that's what we're hoping. We're hoping that we can have more direct effect, and perhaps increase the dose without having a side effect profile. But again, a lot of this is unknown. I cannot comment on whether or not I think it's going to increase over time. I think nobody knows the answer to that. And we'll see what happens when we start to coach from the long-term extension data, safety data for the period.

Question: Greg Harrison - Bank of America - Analyst : Hey, good morning. Thanks for the detailed update and for taking the questions. How would you expect enrollment in the Phase 2 study to be impacted by an increasing number of treatment options in PAH, especially sotatercept down the road?

Question: Greg Harrison - Bank of America - Analyst : Great. If I could sneak one more in, you show on slide 17 that KER-012 does bind to some BMP ligands. What are the risks associated with those specific BMPs, if any?

Question: Eun Yang - Jefferies Group LLC - Analyst : Thank you. I have a question for Dr. Gomberg. So [market's] running Phase 3 trial for sotatercept in newly diagnosed PAH patients. Can you talk about the potential of activin receptor ligand trap in the first line of a PAH, and what would you like to see novel to incorporate the sotatercept or can also draw if we run a Phase three in first line to incorporate it to product in your first line patients? Thank you. Mardi Gomberg - George Washington University, School of Medicine Health Sciences - Chief Clinical Research Officer & Director of the Pulmonary Hypertension Program Sure. So I think from a clinical trial, we need to see the data. And right now, all of our trials are on background therapy. Whether it's initiated within the six months a year, we asked this earlier, but we're not currently looking in any of our clinical studies at immediate use as a first line. It's visible, but not all of our studies dependent of the [telesales]. So right now, we have to use our medications based on what the clinical trial tells us.

Question: Andreas Argyrides - Wedbush Securities Inc. - Analyst : Good morning and thanks for taking our questions. Is there any concern that the wide entry criteria for six-minute walk distance could introduce the risk that less severe patients can be rolled in the trial as physicians might decide to say they're more severe patients for sotatercept if it gets approved? Then also, what is your targeted timeline for enrollment? And then I have one follow-up. Thanks. Mardi Gomberg - George Washington University, School of Medicine Health Sciences - Chief Clinical Research Officer & Director of the Pulmonary Hypertension Program So I guess I'm trying to understand the question, but I think what you're asking is if you allow folks that walk 500 meters, are you going to have less sick patients? And I think over time, we've seen that patients that have elevated PPR still can walk a lot like any cardiovascular disease, the heart accommodates. And you have folks running marathons when they have to be (inaudible). So I'm not concerned that we're going to have less sick patients. I think function class II and function class III have actually brought in six-minute walk distance because we know it's not a perfect test. People can only walk so far in six minutes. It's only to easily differentiate them enough. It's really the hemodynamics that makes the difference.

Question: Andreas Argyrides - Wedbush Securities Inc. - Analyst : Okay, great. And then just one quick one on slide 24 where you have the TROPOS trial design. And the placebo switch to the 3 mg per kg dose. Think you can provide us now behind that, is that potentially the go-ahead dose in future study? Thank you.

Question: Joe Catanzaro - Piper Sandler & Co. - Analyst : Hi, everybody. Thanks for taking my questions here. Maybe first one here on the BMP binding profile as a follow-up to an earlier discussion. I guess my question largely centers around your level of confidence that it's possible to decouple the telangiectasias on the positive benefits on vascular health that you have with this mechanism. And I guess, relatedly, it may be a silly question, but in preclinical rodent models, I guess, Jas, with your experience, is it possible to see some of these bleeding events if you're fully blocking the BMP signaling pathway? Thanks, and I have a follow-up.

Question: Joe Catanzaro - Piper Sandler & Co. - Analyst : Yeah. That's helpful. I guess my follow-up maybe for the company, but also Dr. Gomberg-Maitland. I know the initial focus here is group 1 pulmonary hypertension. But based on 012's mechanism, is there any rationale to potentially exploring the future other WHO pulmonary hypertension groups? Thanks. Mardi Gomberg - George Washington University, School of Medicine Health Sciences - Chief Clinical Research Officer & Director of the Pulmonary Hypertension Program Sure. So the asset four is the fast answer. The company has already started a very small study to kind of test the waters in the heart failure preserved via the [heart failure with reduced IAS] because there's a potential that we can help the heart and the lung. And I think that PAH left heart disease is an area that they can investigate. We need to show evidence of PAH first and then move forward.

Question: Thomas Smith - Leerink Partners LLC - Analyst : Hey, guys. Good morning. Thanks for taking the questions and congrats on the progress. Just two quick ones on TROPOS trial design. I guess first, can you talk a little bit more about the risk factors you're using to stratify patients across the various arms? And then secondly, can you elaborate a little bit on the powering assumptions here and what you're doing with placebo and treatment in factor of PVR and six-minute walk distance? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.

Question: Thomas Smith - Leerink Partners LLC - Analyst : Okay. Understood. Can you elaborate a little bit on some of the assumptions made behind the powering?

Question: Thomas Smith - Leerink Partners LLC - Analyst : Okay, understood. And then can you just comment a little bit on sort of the regional balance between the sites and how you're thinking about US versus ex-US enrollment here?