Phase III Psychedelic Study Nearing Completion - MDD Depression Data in Q4:26

Research evidence excerpt

Phase III Psychedelic Study Nearing Completion - MDD Depression Data in Q4:26

USA | Pharmaceuticals

Helus Pharma EquityJuneResearch24, 2026

FLASH NOTEPhase III Psychedelic Study Nearing Completion

RATING BUY- MDD Depression Data in Q4:26

PRICE $5.08^

We flag HLP003's (oral d-psilocin) pivotal Phase III (APPROACH) in adjunct

PRICE TARGET | % TO PT $22.00 | +333%

MDD has exceeded 86% of patient enrollment (N=189/220), so 12-week topline

52W HIGH-LOW $5.34 - $4.99

data is on track for Q4:26. Ultimately, showing a robust and durable efficacy

FLOAT (%) | ADV MM (USD) 92.5% | 3.48

profile should support a +100-200% stock move (or more), especially following

DFTX's price action after DT120's (oral LSD) Phase III MDD success. HLP003's MARKET CAP $215.8M

second Phase III dataset in 2027 (EMBRACE) implies a pot'l 2028 approval. TICKER HELP ^Prior trading day's closing price unless otherwise

noted.

Big picture: The psychedelic macro backdrop continues to improve, given Big Pharma's

rising interest, JNJ Spravato's (intranasal esketamine) commercial success ($2B+ runrate), a

collaborative FDA (here, here, here, here), and the emergence of several (+) datasets that suggest

psychedelics can profoundly benefit hard-to-treat $1B+ CNS disorders (MDD, TRD, PTSD, SAD,

etc). Looking ahead, COMP360's (oral psilocybin) pot'l FDA approval as early as YE:26/early 2027

could drive significant mindshare. Meanwhile, HLP003 (oral d-psilocin) should have a 60%+ PoS of

succeeding in a Phase III MDD study in Q4:26. The compound has earned an FDA breakthrough

designation (BTD) already on strong Phase II data, with top dose (2x16mg) achieving a 12-month

remission rate of 71% (N=5/7).

In Q4:26, we believe HLP003's 12-week Phase III APPROACH data (N=220) in adjunct MDD could

yield +100-200% stock upside.