Ascendis Pharma A/S R&D Update Transcript

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

Question: Michelle Lim Gilson - Canaccord Genuity Corp., Research Division - Analyst : I guess I'll just do one on kind of each of the 3 programs that you gave clinical updates for. The first on TransCon PTH. You associate this need for -- the increased need for PTH and kind of increased doses over time being related to the bone normalizing and stabilizing. And it seems like in the Phase II extension, it starts around week 26, the bone turnover markers start to come down. And I'm just curious, when you move from Phase II to Phase III, there was a change in the dose titration algorithm and also patients aren't continually titrated. How do you expect those -- do you expect that, that increased or that need for an increased dose of TransCon PTH will be -- I guess will affect the results of the Phase III study at all? And kind of how do you translate that from Phase II to Phase III with the changes you made in those studies?

Question: Michelle Lim Gilson - Canaccord Genuity Corp., Research Division - Analyst : Okay. And do you think that this higher requirement of PTH does the Phase II open-label extension kind of satisfy what the FDA might need to see around it? And has it come up in your discussions with the agencies?

Question: Michelle Lim Gilson - Canaccord Genuity Corp., Research Division - Analyst : Okay. Also for TLR7/8 Agonist program, will you see additional updates -- since it seems like week 9 may not be a long enough time here. And then you saw some very good responses in these early data. And does that suggest that maybe your trial plans are too narrow with only HPV-associated tumors? And then I was wondering if you could comment, you saw some of the scope effects but not affect the original -- at the injected tumor? And can you kind of explain what you're seeing and how you think that this -- do you expect a more robust response over time?

Question: Michelle Lim Gilson - Canaccord Genuity Corp., Research Division - Analyst : And if I can sneak one in on TransCon also. You mentioned that you don't think you need to go above 100 micrograms. How did you determine this because your Phase II dose escalation study, I don't think evaluated doses higher than 100? And then maybe you can touch on the end point in the ACcomplisH infant study?

Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst : First, and maybe this is following up on the last question, but I just want to make sure I understood. Can you just elaborate on what specifically in the blinded data for TransCon CNP helped inform the dose selection for the ACcomplisH China trial? Is the decision to select 1,500 based on biomarkers or blinded height data or both? And if biomarkers, can you tell us which biomarkers informed the dose selection?

Question: Jessica Macomber Fye - JPMorgan Chase & Co, Research Division - Analyst : Great. And can you talk about when we could expect data from ACcomplisH China to get some larger sample size at those higher doses? And I guess related to that, when could we expect Phase III to start for TransCon CNP?

Question: Anita Dushyanth - Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst : Just as a follow-up to the PTH candidate. And at some point you said that the patients would need to have a higher dosing to promote the bone turnover activity. And when that happened, would they still be needing that 600-milligram per day calcium supplement?

Question: Anita Dushyanth - Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst : Okay. That was very helpful. And then my second question is on CNP. Now the candidate is for -- is aching a different place and different joints. So can you maybe just talk about how you sort of plan to check on that in the different joints, the effect of CNP? 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 14, 2021 / 2:00PM, ASND.OQ - Ascendis Pharma A/S R&D Update