
Clinical Programs - Roluperidone (MIN-101) is in Phase 3 development for negative symptoms in schizophrenia, with top-line results expected in Q4 2019 [3, 6, 65] The Phase 3 study design replicates the successful Phase 2b trial [6] The study involves 501 patients randomized 1:1:1 to 32 mg and 64 mg doses of MIN-101 versus placebo [15] - Seltorexant (MIN-202) Phase 2b trial (aMDD2001) showed a statistically significant improvement in MADRS total score at the 20 mg dose compared to placebo (p=0083) [3, 36, 40] A key secondary outcome showed an even greater difference from placebo for the seltorexant 20 mg arm in patients with clinically significant insomnia (ISI ≥ 15) with LS mean difference versus placebo of 49 on the MADRS total score and a 2-sided p-value of 0050 [36] Two further Phase 2b trials with TLR are expected in the near future [44] - MIN-117 is in an ongoing Phase 2b study for major depressive disorder and anxiety, with top-line results anticipated in Q4 2019 [3, 65] The study involves 324 patients [62] Financial Status - The company had a cash balance of $793 million as of March 31, 2019, providing a cash runway to early 2021 [65] Market Opportunity - Negative symptoms are identified as the leading unmet need in schizophrenia by treating physicians [32] - MDD affects 173 million adults in the US (71% of the population over age 18 and over) [47]