Slide 1: HLP004 Positive Phase 2 Data in Generalized Anxiety Disorder
HLP004 Helus Pharma Announces Positive Phase 2 Data For Its Novel Serotonergic Agonist in Generalized Anxiety Disorder (GAD) Helping Minds Heal March 2026 Nasdaq: HELP Cboe CA: HELP
Slide 2: Cautionary Statement
Cautionary Statement The information contained in this presentation has been prepared by the Company. The information contained in this presentation: (a) is provided as at the date hereof, is subject to change without notice, and is based on publicly available information, internally developed data
Slide 3: Leading the Development of Novel Serotonergic Agonists (NSAs)
Leading the Development of Novel Serotonergic Agonists (NSAs) 1,2 Two proprietary clinical programs, HLP003 and HLP 004, targeting major depressive disorder ("MDD") and 1 generalized anxiety disorder ("GAD") with positive Phase 2 safety and efficacy results Lead program HLP003 has been granted U.S.
Slide 4: Executing on Our Innovative Pipeline to Enable a Paradigm Shift in Mental Health
Executing on Our Innovative Pipeline to Enable a Paradigm Shift in Mental Health Indication Preclinical Phase 1 Phase 2 Phase 3 Key Milestones1,2 HLP003 Deuterated Novel Adjunctive Q4 2026: Phase Phase 3 study dosing underway Serotonergic treatment of 3 APPROACH Granted FDA Breakthrough Therapy Desi
Slide 5: HLP004's Emerging Best-in-Class Profile
HLP004’s Emerging Best-in-Class Profile Positive Phase 1 and Phase 2 Results in Moderate-to-Severe Generalized Anxiety Disorder Rapid, Robust Clinically meaningful 10-point HAM-A reduction at 6 weeks (p<0.0001) Treatment Effect with effects seen as early as Day 2 Effects in Real World Effects seen a
Slide 6: Comprehensive Studies Characterizing DMT Pharmacological Properties
Comprehensive Studies Characterizing Dimethyltryptamine (DMT) Pharmacological Properties Study Key Findings Phase 1/2a study with IV DMT in moderate to severe MDD Rapid and durable antidepressant and anxiolytic effects after single administration (no SSRIs)1 Phase 1 IV/IM study1 Characterized safe a
Slide 7: HLP004 Designed to Improve Upon IV DMT
HLP004 Was Designed To Improve Upon IV DMT To Deliver Rapid & Durable Symptom Relief Via Single Treatment Cycle Limitations of IV DMT HLP004 Improved Pharmacokinetic Properties vs. IV DMT • Unfavorable pharmacokinetics: rapid peak, rapid elimination resulting in short-lived, intensive <30 min experi
Slide 8: Linear, Predictable and Reproducible Pharmacokinetics and Pharmacodynamics
Phase 1 Dose Ranging Trial Linear, Predictable and Reproducible Pharmacokinetics and Pharmacodynamics Concentration (ng/mL) Pharmacokinetics Emotional Breakthrough Inventory (EBI)1 • Emotional Breakthrough HLP004 Plasma as measured using EBI is considered predictive of therapeutic changes2 • In the
Slide 9: Intramuscular Administration Permits Rapid Discharge Within 3 Hours
Phase 1 Dose Ranging Trial Intramuscular Administration Permits Rapid Discharge Within 3 Hours N=10 N=6 Acute effects last 90 minutes only3 N=6 N=6 Ready for discharge within 3 hours4 N=6 N=6 allowing for access into existing Spravato LSD2 treatment paradigm Time to Discharge1 (Hours; Mean + SEM) No
Slide 10: Phase 2 Topline Data: HLP004 in Generalized Anxiety Disorder
Phase 2 Topline Data HLP004 in Generalized Anxiety Disorder
Slide 11: High Patient Burden and Persistent Treatment Gaps in GAD
High Patient Burden and Persistent Treatment Gaps in GAD Create a Clear Opportunity for Innovation Significant Unmet Need in GAD Current Treatments Continue to Fail GAD Patients >300M >20M ▪ 2/3 of GAD patients experience no relief with persons worldwide with anxiety persons with GAD in the US2 init
Slide 12: HLP004 Phase 2 Signal Detection Study in GAD
Phase 2 Signal Detection Trial HLP004 Phase 2 Signal Detection Study in GAD Double-blinded Phase 2 study of HLP004 as an adjunctive treatment on top of SOC for patients suffering with GAD HLP004 Phase 2 Clinical Trial Design • Age 18–65 with diagnosis of GAD Key • Currently on stable dose of antidep
Slide 13: Baseline Characteristics Demonstrate Real World Treatment Paradigm
Phase 2 Signal Detection Trial Baseline Characteristics Demonstrate Real World Treatment Paradigm 20 mg 2 mg Overall Characteristic (n=25) (n=11) (n=36) Key Takeaways Age (years); Mean (SD) 34.6 (9.92) 42.4 (12.14) 37.0 (11.08) ▪ Moderate-to-severe patients (average HAM-A lower than monotherapy tria
Slide 14: Generally Well-Tolerated, Transient Adverse Events, No Drug Related SAEs
Phase 2 Signal Detection Trial Generally Well-Tolerated, Adverse Events were Transient, with No Drug Related Serious Adverse Events Recorded SOC Psychiatric Disorders 20 mg 2 mg Total All AEs were mild/moderate AEs > 10% across all participants N (%) N (%) N (%) No severe or serious AEs Hallucinatio
Slide 15: Rapid and Profound Effects over SoC, Sustained Through at Least 6 Months
Phase 2 Signal Detection Trial HLP004 Demonstrated Rapid and Profound Effects over SoC, with Effects Sustained Through at Least 6 Months Anxiety Symptom Improvement Meets Durable Anxiety Symptom Primary Endpoint at 6 Weeks Improvement Through 6 Months Treatment Period HAM-A Total Not powered to show
Slide 16: Single Treatment Cycle Resulted in ~70% Responders and ~40% Remitters at 6 Months
Phase 2 Signal Detection Trial Single HLP004 Treatment Cycle Resulted in ~70% Responders and ~40% Remitters at 6 months Responders and Remitters at 6 Weeks Responders and Remitters at 6 Months % Responder or Remitter % Responder or Remitter N=12/18 No observed N=13/22 regression to baseline unlike p
Slide 17: Impact of HLP004 in Real World Clinical Setting
Impact of HLP004 in Real World Clinical Setting Illustrative Benefit of Adjunctive Treatment in GAD 22.4 * Adjunctive HLP004 Effect Illustrative data only; from multiple different trials, study designs; therefore, not like-for-like comparison +10.4 Approved Monotherapies 13.4 12.4 12.5 11.9 10.9 11.
Slide 18: HLP004's Emerging Best-in-Class Profile As a Short Acting Treatment
HLP004’s Emerging Best-in-Class Profile As a Short Acting Treatment for Psychiatric Conditions Fits Spravato’s Durability with Patient Acute Subjective Ready to Single Treatment Intellectual Commercial Single Treatment Population in AEs Effects Discharge Cycle Property Model Cycle Trial 100% Real- H
Slide 19: Leading the Development of Novel Serotonergic Agonists (NSAs)
Leading the Development of Novel Serotonergic Agonists (NSAs)1,2,3 Following HLP004’s positive Phase 2, Helus now has two late-stage programs in large psychiatry markets of 1 MDD and GAD with near-term valuation catalysts Proprietary novel entities supported by robust intellectual property portfolio
Slide 20: Thank You
Thank You HELUS PHARMA