INM-901 — FDA meeting
Q3 2026
Conduct a pre-IND meeting with the U.S. Food and Drug Administration in the third quarter of 2026.Source filing
INMED PHARMACEUTICALS INC · Data as of 2026-09-08
Q3 2026
Conduct a pre-IND meeting with the U.S. Food and Drug Administration in the third quarter of 2026.Source filing
Q4 2026
Planning for a pre-IND meeting with the FDA in Q4 2026.Source filing
2027
• Subject to regulatory feedback and completion of IND-enabling activities, the Company targets submission of an IND and initiation of a Phase 1 clinical trial in 2027.Source filing
2027
These programs include MT-001, an anti-PACAP (pituitary adenylate cyclase-activating polypeptide) monoclonal antibody with Phase 2a proof-of-concept data expected in 2028, and MT-002, a potentially first-in-class anti-CGRP (calcitonin gene-related peptide) and anti-PACAP bispecific antibody with Phase 1 healthy volunteer data expected in 2027.Source filing
1Q 2027
First-in-human regulatory filings for MT-001 (anti-PACAP) and MT-002 (anti-CGRP x PACAP bispecific) expected mid-2026 and 1Q 2027, respectivelySource filing
2028
These programs include MT-001, an anti-PACAP (pituitary adenylate cyclase-activating polypeptide) monoclonal antibody with Phase 2a proof-of-concept data expected in 2028, and MT-002, a potentially first-in-class anti-CGRP (calcitonin gene-related peptide) and anti-PACAP bispecific antibody with Phase 1 healthy volunteer data expected in 2027.Source filing
into 2029
The financing, based on current plans, extends Mentari's cash runway into 2029 and through phase 2a readout on each of the two PACAP-targeted lead programs, including MT-002.Source filing