FSCD KOL Conversation Takeaways

Research evidence excerpt

FSCD KOL Conversation Takeaways

r and whose clinical work includes active Q2 (34.78) - (0.34) - -

Q3 (34.78) - (0.40) - -

involvement in the STAR Consortium with an aim toward pioneering novel Q4 (38.89) - (0.62) - -

endpoints for intestinal fibrosis. Much of our conversation focused on Agomab’s e = Morgan Stanley Research estimates

development efforts and potential regulatory dynamics in FSCD. Recall, FSCD is a

severe complication of Crohn's disease caused by a narrowing of the intestinal

lumen due to fibrosis with no approved pharmacologic therapies. Ontunisertib is a

gut-restricted ALK5 inhibitor that may be able to address fibrosis without the

systemic toxicity risk associated with historic ALK5/TGF-ß approaches. In the coming

months, AGMB will continue to lead the industry's clinical and regulatory efforts in

FSCD with the dosing of the first patient in the Ph2b NOV-ERA study and disclosure

of the full Part B (OLE) data from the Ph2a STENOVA study, where we will be

looking for a consistent safety profile and potentially (numerically) improved event

rates vs. natural history in the context of (ideally) supportive imaging measures.

Learnings from the Ph2a STENOVA study. The KOL noted uncertainty around

safety heading into STENOVA because of the historic toxicity (e.g., cardiac valve

damage) associated with systemic ALK5/TGF-ß inhibition. However, the KOL was

very positive on safety data reported from the study so far, which did not point to a Morgan Stanley does and seeks to do business with

serious safety signal or ALK5-related toxicity (we also note recent FDA alignment on companies covered in Morgan Stanley Research. As a result,

investors should be aware that the firm may have a conflict of

inclusion of the higher 400mg BID dose in the Ph2b study).