Helus Pharma says Phase 3 results for its psilocin analog CYB003 are due this quarter

What Helus says about the results

On Oct. 21, Helus said its "HLP003 APPROACH Phase 3 topline data readout is on track for Q4 2026."¹ HLP003 is the company's new name for CYB003, which is still the name on the trial registry.⁷ On Oct. 27 the company repeated that it "continues to anticipate reporting topline data" from APPROACH this quarter.² Topline results are a company's first summary of the main outcome, not the full data.

No results were public as of Nov. 2. The company's latest report to the SEC, filed Oct. 27, didn't include them, and none were posted on the registry.⁹⁴

Cybin Inc. legally became Helus Pharma Inc. on Oct. 1, after shareholders approved the change Sept. 22; its shares trade as HELP on Nasdaq and Cboe Canada.³ On Oct. 27, co-founders Eric So and Paul Glavine stepped down from their executive and consulting roles and stayed on the board.²

Is CYB003 psilocybin?

No. The registry describes CYB003 as "a Deuterated Psilocin Analog."⁴ Psilocin, also spelled psilocyn, is what the body makes from psilocybin; a DEA notice calls it "the active metabolite of psilocybin."⁸ Deuteration means some hydrogen atoms are swapped for deuterium, a heavier form of hydrogen; Helus describes its method as "selective substitution of hydrogen atoms with deuterium."⁷ CYB003 is a lab-made molecule related to psilocin. It isn't psilocybin, and it isn't a mushroom product.

How the APPROACH trial worked

APPROACH enrolled 223 adults with major depressive disorder who were on a stable antidepressant but, in the company's words, "responding inadequately," and they stayed on it.⁴⁷ Participants received either 16 mg of CYB003 or a placebo in two sessions about three weeks apart, with psychological support in both groups.⁴ The main measure is the change in the MADRS depression score six weeks after the first session.⁷ The registry lists 45 U.S. sites, primary completion on Sept. 4, 2026 and study completion on Oct. 23, 2026.⁴

Which South Florida clinics took part?

APPROACH's record lists eight Florida sites. Three are in South Florida: Floridian Neuroscience Institute in Miami, Research Centers of America in Hollywood, and a site named Segal Trials West Broward whose listed city is North Miami. The others are in Maitland, Orlando (three) and Tampa.⁴

The second Phase 3 trial, EMBRACE, is still recruiting, with Florida sites in Jacksonville, Maitland, Naples and Tampa and none in Miami-Dade, Broward or Palm Beach.⁵ EXTEND, a long-term follow-on study, enrolls by invitation from the two trials; its Florida sites include Hollywood and Lauderhill.⁶

Why it matters in Miami

These will be the first Phase 3 efficacy results for this drug, from a trial that listed clinics in Miami-Dade and Broward among its 45 U.S. sites.⁷⁴ They'll help show whether a second psilocybin-related drug follows Compass Pathways' COMP360, which Compass expects to finish filing with the FDA this quarter.

Helus says it expects to file its own New Drug Application in 2028.¹ On March 13, 2024, it announced that the FDA had granted the drug Breakthrough Therapy designation.⁷ The FDA says that designation is not "an FDA determination of safety or effectiveness."¹⁰ For South Floridians looking for a study, our Florida trials tracker lists what's recruiting.