The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Corinne Johnson - Goldman Sachs & Co. LLC - Analyst
: Good morning. Thanks guys. Maybe a couple of questions from us. On the Phase 3 design, I guess what portion of the patients and what absolute
number of patients with the ESA naive in the Phase 3 study? And I guess, how are you thinking about that in terms of positioning this drug for
potentially is it frontline usage? And then how big of a front-line population will be needed to support that approval?
Question: Corinne Johnson - Goldman Sachs & Co. LLC - Analyst
: Okay, it was a bit confusing. I thought it was the [ESAs] and then ineligible as a separate group, but that makes more sense. And then in terms of
then the number of patients like that, is that present with or are ESA ineligible at diagnosis, I guess, can you remind us what the size of that patient
population is?
Question: Corinne Johnson - Goldman Sachs & Co. LLC - Analyst
: Yeah. Just what portion of patients kind of present with disease that is ESA ineligible or that would be within that cohort?
Question: Corinne Johnson - Goldman Sachs & Co. LLC - Analyst
: Okay. Thank you.
Question: Kripa Devarakonda - Truist Securities, Inc. - Analyst
: Hey, guys. Thank you so much for taking my question and congrats on all the progress. I just have a follow-up question to the previous questions,
continuing on the Phase 3 trial design. One would, (inaudible) you talked about more operational steps remaining. Can we just get a sense what
time lines we can expect in terms of the initiation.
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And on the non-RS patients may continue to have smaller group at least where we see the response rate in the target population. Just broadly
thinking about the Phase 3 trials, do you expect there to be a minimum percent of non-RS patients that you would want to enroll so that you could
be considered for an all-comers approval? Thank you.
Question: Kripa Devarakonda - Truist Securities, Inc. - Analyst
: Yeah. Thank you. Thank you so much.
Question: Thomas Smith - Leerink Partners LLC - Analyst
: Hey, guys, good morning. Thanks for taking the questions and congrats on the data updates. Just two on Elritercept, please. With respect to the
Phase 3 pivotal trial design, can you comment on how you're thinking about the underlying patient population and their baseline transfusion
burden? Are you going to trying to enrich for those high transfusion burden patients where you're clearly having an outsized effect?
And then secondly, we know the agency has been focused on quality of life improvements here beyond just the transfusion in dependence rates.
It looks like you're seeing nice improvements in the FACIT-Fatigue scores. Can you just talk about how you're thinking about incorporating this
into a Phase 3 study? Is there anything you can do to help enrich the patient population to show benefit there?
Question: Thomas Smith - Leerink Partners LLC - Analyst
: Got it. That makes sense. And if I could just squeeze in one follow-up question on Cibotercept. Just wondering if you could comment on the feedback
you're receiving from your clinical trial sites and investigators in the US posted titers at approval. Are there certain patients at these sites see a
better candidate score, the 012 study rather than trying them on commercially available [Cibotercept].
Question: Thomas Smith - Leerink Partners LLC - Analyst
: Got it. That's helpful color. Thanks for taking the questions, Jas, appreciate it.
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JUNE 17, 2024 / 12:00PM, KROS.OQ - Keros Therapeutics Inc to Host a Corporate Update Call
Question: Tyler Van Buren - TD Securities (USA) LLC - Analyst
: Hey, guys, good morning. Thanks for the presentation. Couple. First one, so for Elrit, the goal is clearly to replicate these results in Phase 3 and your
Phase 3 design seems pretty straightforward so far. So I guess just to be clear, can you highlight the key difference -- any key differences to the
luspatercept Phase 3 COMMANDS trial that will allow you to differentiate if there are any.
And then the second one is just regarding your update on plan for enrollment completion for the Phase 2 TROPOS for Cibotercept by Q4. Can you
tell us what percent of patients have been enrolled in the trial to date so we can get a sense of how far along you guys are.
Question: Jason Zemansky - BofA Securities, Inc. - Analyst
: Good morning. Congratulations on the progress and thanks so much for taking our questions, two, if we may. It seems that there was a pretty stark
difference between responders and non, at least in terms of durability according to your KM curve. Any sense of what's driving that or any insights
behind that?
And then secondarily, congratulations, it looks like FDA was willing to go along with kind of opening up the population to the broadest measures
there. But I'm curious, was there anything or anything you can share regarding their openness or willingness to look at particularly those ring with
and without ring sideroblasts in terms of giving them comfort there. Thanks so much.
Question: Jason Zemansky - BofA Securities, Inc. - Analyst
: Great. Thanks for the color.
Question: Matt Phipps - William Blair - Analyst
: Thanks for taking my question and congrats on the updates and FDA feedback. I was curious in the MDS trial, how many patients end up getting
up titrated to that 5 mgs per kg level? And I assume you'll use similar criteria and ability to up titrate in the Phase 3 trial? And also will you include
any (inaudible) experienced patients. Thank you.
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JUNE 17, 2024 / 12:00PM, KROS.OQ - Keros Therapeutics Inc to Host a Corporate Update Call
Question: Julian Harrison - BTIG, LLC - Analyst
: Good morning. Thank you for taking my questions. I'm curious if you can share the median time from diagnosis to enrollment both for your Phase
2 MDS and MF trials. Also, if you've identified any mutations that look predictive of response in either trial, that would be helpful to know. And then
finally, can you remind us why you believe COMMANDS is not a good reference point for your Phase 2 MDS results.
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