Helus Pharma (HELP) investor relations material

Company overview and leadership

• Focuses on developing novel serotonergic agonists for mental health, with a platform spanning late, mid, and early-stage programs.

• Lead program is deuterated psilocin for adjunctive major depressive disorder (MDD), with phase III data expected in Q4.

• Mid-stage program HLP004 targets generalized anxiety disorder, with phase II completed and next trial design to be announced soon.

• Early-stage HLP005 is a preclinical library for mental health indications, aiming to advance a lead molecule in 2027.

• CEO joined in August, citing strong assets, team quality, and robust IP as key attractions.

Clinical development and strategy

• Execution is the top priority, focusing on clinical milestones and scalable infrastructure for future commercialization.

• Adjunctive MDD chosen for its broad reach: 23 million in the US with MDD, 70% on standard care, and 2/3 not getting optimal benefit.

• Adjunctive approach allows adding therapy without washout, aligning with real-world clinical practice.

• HLP003 phase III PARADIGM program includes two pivotal trials (APPROACH and EMBRACE) and a long-term extension, supporting an NDA filing in 2028.

• FDA breakthrough therapy designation and rolling submission process could enable approval in 2028.

Clinical data and expectations

• Phase II data for HLP003 showed 13-14 MADRS point improvement after one dose, with further gains after a second dose and durable effects up to a year.

• 100% responder rate and over 70% remission observed, with mild to moderate, transient adverse events and no severe events.

• Clinically meaningful MADRS difference is 4-5 points; HLP003's phase II results exceed this benchmark.

• Q4 APPROACH trial readout will include primary and key secondary endpoints, plus safety data.