Keros Therapeutics Inc To Host Update Call Transcript

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

Question: Greg Harrison - Scotiabank - Analyst : Thanks for taking the question. I'm wondering if you could just give a couple more details about the number of patients who experienced the pericardial effusion, how severe the events were, and how they have resolved or if they've resolved.

Question: Greg Harrison - Scotiabank - Analyst : That's helpful. Thanks.

Question: Tyler Van Buren - TD Cowen - Analyst : Thanks for the update. Is there any indication that this could be due to manufacturing of the product potentially? And have you seen any of these events in the placebo arm as the disease is getting worse?

Question: Joseph Catanzaro - Piper Sandler & Co. - Analyst : Hey guys, thanks for taking my question. Maybe one for me on your understanding around whether this is dose related or not. Whether you're seeing this occur at a higher rate of 4.5 mgs/kg. And then I guess maybe somewhat relatedly your comfort level around 1.5 mg/kg dose, whether you've seen any events there, but the risk benefit is still favorable enough to continue? And then I guess the last question. In the events you've seen, have these been associated with PVRs or pulmonary pressure actually going up and whether you know that or not?

Question: Joseph Catanzaro - Piper Sandler & Co. - Analyst : Okay. Thanks. Maybe on my last question, maybe you don't know or can't say, but whether the events you've seen have been associated with PVR or pulmonary pressure actually going up in those patients.

Question: Joseph Catanzaro - Piper Sandler & Co. - Analyst : Okay, got it. Thanks so much.

Question: Thomas Smith - Leerink Partners LLC - Analyst : Hey guys, good morning. Thanks for taking the questions. When you're looking across the baseline characteristics here for the patients that were enrolled in TROPOS, how do these patients compare versus stellar or pulsar these patients with more or less severe disease at baseline? And then I guess as a follow up with no changes to the low dose arm, can you just remind us the level of target engagement you're observing there and what your expectations are for treatment affected that dose?

Question: Thomas Smith - Leerink Partners LLC - Analyst : Understood. That makes sense. And just with respect to the 1.5 mg/kg dose level, can you just remind us on the target engagement there and what your expectations are in terms of treatment effect?

Question: Thomas Smith - Leerink Partners LLC - Analyst : Got it. That makes sense. Thanks for taking the questions. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 12, 2024 / 1:00PM, KROS.OQ - Keros Therapeutics Inc To Host Update Call

Question: Vamil Divan - Guggenheim Securities, LLC - Analyst : Thanks for taking the question. So I think along the same lines of some of the other questions, I'd appreciate -- you may not be able to answer this fully but yes, I guess just given your experience with this mechanism and prior work from the other companies in the space, I'm just curious if this is sort of mechanism related? If it is drug related, kind of what would be the mechanism driving the development of pericardial effusion? I don't know if you can comment on that. And also I'm curious with all the work you've done with other TGF- in other disease conditions. Can you comment on this? I think we look back and look like at least with [one seller on] product this was seen in a patient was increased for DMD. I'm just trying to see beyond PAH any experience or history you can share with pericardial effusion that have been seen with other agents would be helpful.

Question: Vamil Divan - Guggenheim Securities, LLC - Analyst : Okay. All right, thank you.

Question: Matt Phipps - William Blair & Company, L.L.C. - Analyst : Thanks for taking my question. Sorry for the -- hear the update. Is there rationale or possibility to add a lower dose or move patients who are still on the 3 or 4.5 to a lower dose? And then also, I know you mentioned the change in bone-specific (inaudible) at these lower doses. But did you see changes in NT-proBNP at a, 1.5 mg/kg dose?

Question: Matt Phipps - William Blair & Company, L.L.C. - Analyst : And then it changes an NT-proBNP that I want (inaudible) --

Question: Matt Phipps - William Blair & Company, L.L.C. - Analyst : Okay, thanks Jas.

Question: Jason Zemansky - BofA Global Research - Analyst : Good morning, apologies on the setback. And thank you for taking our question. I just wanted to follow up on a couple of your previous comments here. First, regarding the timing of updates. Do you imagine that you'll have an ability to comment prior to the second quarter '25 top-line release? Have any of the regulatory bodies including FDA commented on this decision to discontinue these dosing at the higher levels. And then any possibility that you'll be able to adjust the trial to eventually potentially move some of these individuals at the higher doses to the lower doses? I guess, curious as to whether there's confidence that the pericardial effusion won't manifest at these lower doses.

Question: Jason Zemansky - BofA Global Research - Analyst : About the trial design (inaudible). REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 12, 2024 / 1:00PM, KROS.OQ - Keros Therapeutics Inc To Host Update Call

Question: Jason Zemansky - BofA Global Research - Analyst : Got it. Thank you so much for the color.

Question: Prakhar Agrawal - Cantor Fitzgerald & Co. - Analyst : Thanks for taking my questions. So maybe on the background rate of pericardial effusion in PAH patients. Are there sub-segments that seem to have a higher rate of these events like PH CTD, the connective tissue disease? And yeah, and maybe if you can comment on the time course of these events, if that's something that you can disclose? When did these events happened, was it at the initial part of dosing or towards the latter part of dosing? And then I have one more? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 12, 2024 / 1:00PM, KROS.OQ - Keros Therapeutics Inc To Host Update Call

Question: Prakhar Agrawal - Cantor Fitzgerald & Co. - Analyst : Okay. And so maybe on the 1.5 mg/kg dose. So maybe just to follow up on some prior questions. Do you expect this dose to match so that an [efficacy] based on whatever you have seen in terms of the target engagement and the PK/PD differences? And do you still expect the drug to have safety differentiation on the bleeding side of things?

Question: Yun Zhong - Wedbush Securities Inc. - Analyst : Thank you very much for taking the questions. Just wanted to confirm the top-line data in second quarter of 2025. Would that be from the 1.5 mg/kg dose cohort alone or will you also report some type (inaudible) from the other two dose cohort? And secondly, say, well, assuming you find some important information regarding the cause of the side effect. So do you plan to provide an update before the second quarter top-line data readout if you do find something?

Question: Andreas Argyrides - Oppenheimer & Co. Inc. - Analyst : Thanks for taking our questions and I'll let go the shock and the disappointment for today's update. Lots of good questions asked and I can appreciate that you guys can't give too much color. But maybe just going back to the dose selection and talking about the target engagement that you've seen at the multiple dose levels. And what was necessarily the rationale to go to 3 or 4.5 mgs which are magnitudes above what sotatercept is currently dosed at? And then as far as ongoing safety updates, how frequently does the DSMB check and monitor? And I guess it's been asked again, but when they -- when we possibly could expect the next update?

Question: Andreas Argyrides - Oppenheimer & Co. Inc. - Analyst : Okay. Thanks for the update, guys. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 12, 2024 / 1:00PM, KROS.OQ - Keros Therapeutics Inc To Host Update Call

Question: Tyler Van Buren - TD Cowen - Analyst : Thanks so much for taking the follow up. I was just wondering if you can comment on the timing of the onset of the events and when they start to appear because you started the trial late July 2023, enrollment completed recently at the end of September '24. So I presume these events must have occurred more recently. So they're either occurring many months into dosing patients or somehow they occurred quickly in the final patients that were enrolled in the trial.

Question: Tyler Van Buren - TD Cowen - Analyst : Okay. Thanks. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 12, 2024 / 1:00PM, KROS.OQ - Keros Therapeutics Inc To Host Update Call