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NASDAQ: HELP |  CBOE CA: HELP

Development Pipeline

Pioneering the Development of Innovative, Next-Generation Therapies

Turning Novel Serotonergic Agonists into Breakthroughs in Mental Health
PROGRAM
INDICATION
  • PRECLINICAL
  • PHASE 1
  • PHASE 2
  • PHASE 3
NEXT MILESTONES 1, 2
HLP003
 Deuterated
NSA
(Oral)
Adjunctive treatment of Major Depressive Disorder (MDD)
Phase 3 study dosing underway. Granted FDA Breakthrough Therapy Designation
Q4 2026: Phase 3 APPROACH topline data
HLP004
 Deuterated
NSA
(Intramuscular)
Generalized Anxiety
Disorder (GAD)
Phase 2 study enrolment complete
Q1 2026: Phase 2 topline data readout
HLP005
 Phenethylamines
and
tryptamines
CNS Disorders
Preclinical

HLP003
Deuterated NSA (Oral)

Indication:

Adjunctive treatment of Major Depressive Disorder (MDD)

Phase:

Phase 3 study dosing underway. Granted FDA Breakthrough Therapy Designation

Next Milestones: 1,2

Q4 2026: Phase 3 APPROACH topline data

HLP004
Deuterated NSA (Intramuscular)

Indication:

Generalized Anxiety Disorder (GAD)

Phase:

Phase 2 study enrolment complete

Next Milestones: 1,2

Q1 2026: Phase 2 topline data readout

CYB005
Phenethylamines and tryptamines

Indication:

CNS Disorders

Phase:

Preclinical

Next Milestones: 1,2

Coming Soon

Notes:

1) Forward-looking statements are subject to risks and assumptions.
2) Subject to receipt of all necessary regulatory approvals from all applicable governmental authorities, including, as applicable, the academic and scientific organizations with which Helus is working. There are multiple risk factors regarding the ability to successfully commercially scale a chemically synthesized process to obtain psilocin and other analogues.

We are a Clinical Stage Biopharmaceutical Company Approaching Key Near-Term Milestones

  1. Lead program HLP003, which has been granted FDA Breakthrough Therapy Designation, is in Phase 3 development for the adjunctive treatment of MDD1
  2. HLP004 in development for generalized anxiety disorder with top line Phase 2 safety and efficacy data expected in Q1 2026.
  3. Robust pipeline of proprietary NSAs with potential for expansion into additional mental health indications with high unmet need affecting >200M people in the U.S.2
  4. Strong Intellectual Property Portfolio with over 100 granted patents and over 250 patent applications pending
Notes:

1) Forward-looking statements are subject to risks and assumptions.
2) Based on estimated addressable markets for indications including depression, anxiety disorders/PTSD, bipolar disorder, substance use/addiction, eating disorders, cluster headaches/migraine, and chronic pain management

Lead Clinical Development Programs

HLP003:
Deuterated Novel Serotonergic Agonist Program
Designated as a Breakthrough Therapy by the FDA

HLP003 is a proprietary molecule, which is part of a family of molecules that includes more common neurotransmitters like serotonin. HLP003 produces pharmacological effects primarily by activating the serotonin 5-HT2A, as well as other serotonin receptors. HLP003 is being developed with the goal of creating a paradigm shift in efficacy and durability for major depressive disorder (MDD). HLP003 is protected by a U.S. composition of matter patent expected to provide coverage until at least 2041. 

HLP003 has received the first known FDA Breakthrough Therapy Designation for an adjunctive NSA for MDD, expediting the clinical development timeline and the regulatory pathway towards potential approval. 

Development status: Dosing underway in Phase 3 PARADIGM program evaluating HLP003 in participants with moderate to severe MDD 

Upcoming milestones: APPROACH topline data in Q4 2026 

For more details on the Company’s HLP003 program, please visit the HLP003 Page.

HLP004:
Deuterated Novel Serotonergic Agonist Program

HLP004, Helus Pharma’s proprietary deuterated NSA program, is in development for the potential treatment for Generalized Anxiety Disorder (“GAD”). HLP004 is protected by a U.S. composition of matter patent expected to provide coverage until at least 2041. 

Helus Pharma has leveraged clinical data from its completed clinical trials, to optimize the development of the HLP004 program. To date, Helus Pharma has completed five clinical trials across several molecules: HLP004 (IV), SPL028 (IV/IM), and SPL026 (IV/IM). This has led to the development of a convenient and scalable intramuscular formulation, demonstrating proof-of-concept in treating depression, supporting the development of HLP004 for the treatment of anxiety disorders. 

Development status: Phase 2 study enrollment complete

Upcoming milestones: Phase 2 HLP004 safety and efficacy data in GAD expected Q1 2026.

For more details on the Company’s HLP004 program, please visit the HLP004 page.