Grace Therapeutics, Inc. · NASDAQ:GRCE
Grace Therapeutics — Investor Presentation (2026)
29 slides from Grace Therapeutics's investor presentation, 2026
Slide 1: Corporate Presentation Fall 2026
Corporate Presentation Fall 2026
Slide 2: Forward Looking Statements
Forward Looking Statements Summary Statements in this presentation that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as
Slide 3: Executive Summary
Executive Summary Summary GTx-104 | aSAH Nimodipine is the SoC and GTx-104 – novel intravenous Pivotal Phase 3 STRIVE-ON clinically de-risked; however, nimodipine – well positioned to safety trial met primary endpoint; significant unmet needs remain solve oral challenges and clinical evidence of GTx
Slide 4: Path to NDA Resubmission Following FDA Type A Meeting
Path to NDA Resubmission Following FDA Type A Meeting A CMC and manufacturing matter — CRL did not identify any clinical safety or efficacy deficiencies and did not request additional clinical data The CRL in context Defined path to resubmission What it is NOT Current CDMO • Not an efficacy or safet
Slide 5: aSAH is a Rare and Severe Acute Brain Injury
aSAH is a Rare and Severe Acute Brain Injury • aSAH results in bleeding over the surface of the Occurs in Relatively Young Patients (~50% <60 yrs) brain in the space between the brain and skull • Primary cause is rupture of an aneurysm • Condition can occur quickly, immediate intervention is key to
Slide 6: Oral Nimodipine – The aSAH Standard of Care for >3 Decades
Oral Nimodipine – The aSAH Standard of Care for >3 Decades 2023 AHA/ASA Guidelines For the management of patients with aSAH Nimodipine is the only approved therapy to improve neurological outcomes Limited use of off-label therapies due to The Joint Commission monitoring adherence to care guidelines
Slide 7: Nimodipine – Consistent Drug Administration Drives Positive Patient Outcomes
Nimodipine – Consistent Drug Administration Drives Positive Patient Outcomes Infarction Rates by Nimodipine Dose Reduction Status Hunt Hess 1-3 Received Reduced Nimodipine Course P = 0.037 Received Full Nimodipine Course Hunt Hess 4-5 Received Reduced Nimodipine Course P = 0.061 Received Full Nimodi
Slide 8: Substantial Shortcomings of Oral Nimodipine
Substantial Shortcomings of Oral Nimodipine Administration Challenges 3 Sub-optimal Therapeutic Benefit with Oral Administration • High dosing burden of 60mg (2 x 30mg High Pharmacokinetic Variability capsules), 6 times per day • Inconsistent plasma concentration in both inter and intra subject • 45
Slide 9: GTx-104 is a Novel IV Nimodipine Designed to Overcome Oral Delivery Challenges
GTx-104 is a Novel IV Nimodipine Designed to Overcome Oral Delivery Challenges Supported by Strong IP, Ph. III Trial Success GTx-104 A novel intravenous nimodipine that is well positioned to solve oral challenges and potentially displace oral as SoC Orphan Drug Status with the potential Pivotal Phas
Slide 10: Established Scientific Bridge between GTx-104 and Oral Nimodipine
Phase 1 Trial Established Scientific Bridge between GTx-104 and Oral Nimodipine Trial met all primary and secondary endpoints; enabling the 505(b)2 regulatory pathway GTx-104 IV infusion vs Oral Capsule: 1000 AUC Day 3 0-24hr GTx-104 900 800 700 Consistent and predictable AUC dav-3 0-24hour plasma c
Slide 11: STRIVE-ON Phase 3 Trial
STRIVE-ON Phase 3 Trial
Slide 12: GTx-104 STRIVE-ON Phase 3 Pivotal Safety Trial Design
GTx-104 STRIVE-ON Phase 3 Pivotal Safety Trial Design Trial complete and reported topline data in January 2025 STRIVE-ON (NCT05995405) is a ~100-patient prospective, open-label, randomized (1:1 ratio), parallel group trial of GTx-104 compared with nimodipine oral capsules in patients hospitalized fo
Slide 13: STRIVE-ON Trial Data Support Potential Clinical, Pharmacoeconomic, and Dosing Benefits
STRIVE-ON Trial Data Support Potential Clinical, Pharmacoeconomic, and Dosing / Administration Benefits over Current SoC, Nimodipine Oral Capsules 90-DAY OUTCOMES (MRS*) HYPOTENSION EVENTS DOSE INTENSITY CLINICAL +29% relative increase in -19% reduction 54% vs. 8% with oral capsules patients with go
Slide 14: Demographics & Baseline Characteristics
Demographics & Baseline Characteristics Demographics well-balanced, except higher proportion of most severe with worst prognosis (Grade V) in GTx-104 GTx-104 Nimodipine Oral Capsules (N = 50) (N = 52) Age (mean) 55 56 Sex, n (%) Female 33 (66.0%) 33 (63.5%) Male 17 (34.0%) 19 (36.5%) Hunt & Hess Gra
Slide 15: Primary Endpoint – Clinically Significant Hypotension
Primary Endpoint – Clinically Significant Hypotension ~19% relatively fewer patients with clinically significant hypotension in GTx-104 GTx-104 Nimodipine Oral Capsules (N = 50) (N = 52) n (%) n (%) Clinically Significant 14 (28%) 18 (35%) Hypotension* * Clinically significant hypotension: decrease
Slide 16: Relative Dose Intensity (RDI)
Relative Dose Intensity (RDI) 54% of patients on GTx-104 had RDI of 95% or higher versus 8% on Nimodipine Oral Capsules GTx-104 Nimodipine Oral Capsules % (N) PATIENTS BY RDI 8% (4) 54% (27) 38% (20) 14% (7) 37% (19) 14% (7) 18% (9) 17% (9) GTX-104 (N=50) ORAL NIMODIPINE (N=52) <80 80-89 90-94 >=95
Slide 17: Clinical Outcomes – mRS (day 90)
Clinical Outcomes – mRS (day 90) ~29% relative increase in patients with good recovery in GTx-104 CLINICAL OUTCOMES 0% (0) GTx-104 (N=47*) 15% (7) 26% (12) 21% (10) 15% (7) 6% (3) 17% (8) ~29% Nimodipine Oral Capsules (N=46**) 20% (9) 13% (6) 15% (7) 24% (11) 9% (4) 11% (5) 9% (4) No Symptoms No Sig
Slide 18: Clinical Outcomes – QoL (Quality of Life; day 90)
Clinical Outcomes – QoL (Quality of Life; day 90) Patient-reported health scores favor GTx-104 QoL GTx-104 Nimodipine Oral Capsules (N = 381) (N = 402) Your Health Today Score 75 70 mean (0 = being worst -> 100 = great) Mobility, n (%) I have no or some problems 38 (100%) 35 (88%) I am confined to b
Slide 19: Safety
Safety Overall safety was comparable between the two groups Summary of Adverse Events (AEs) GTx-104 Nimodipine Oral Capsules (entire study duration of 90 days) (N = 50) (N = 52) All AEs, n (%) # of events 44 (88%) 157 43 (83%) 193 All AEs, events per n 3.6 4.5 All SAEs1, n (%) # of events 18 (36%) 3
Slide 20: ICU Length of Stay, Mechanical Ventilator & Readmissions
ICU Length of Stay (los), Mechanical Ventilator & Readmissions 1.5 fewer ICU days, 5 fewer ventilator days, and 48% relatively fewer ICU readmissions in GTx-104 GTx-104 Nimodipine Oral Capsules (N = 50) (N = 52) ICU los, days 16.4 (6.7) 17.9 (10.4) Mean (SD) Mechanical Ventilation days 5.6 (5.7) 10.
Slide 21: Pharmacoeconomics
Pharmacoeconomics Major patient resource utilization drivers in aSAH favor GTx-104 GTx-104 Nimodipine Oral Capsules (N = 50) (N = 52) n* n* Day 1 Day 14 % change Day 1 Day 14 % change Mechanical Ventilation 14 1 -93% 12 7 -42% External Ventricular Drain 32 10 -69% 35 17 -51% Deep Sedation 5 1 -80% 8
Slide 22: Commercial Preparation
Commercial Preparation A) 3<8lace
Slide 23: aSAH Market Opportunity
aSAH Market Opportunity Addressable Patients Most Critical Unmet Needs • Literature, typically limited to basal cistern aSAH • ~45% of treated patients are unconscious or (~80% of aSAH), suggests ~42.5K U.S. hospital- dysphagic (nasogastric tube) treated patients • Claims analysis suggests incidence
Slide 24: GTx-104 target product profile is seen as valuable for improved tolerability, cost savings, and easy IV use
GTx-104 target product profile is seen as valuable for its improved tolerability, cost savings, and easy IV use – with broad formulary inclusion by P&T committee Primary Market Research Insights (2Q 2025) EFFICACY PHARMACOECONOMIC ROA (route of admin) Respondents emphasized that reduction in HCPs hi
Slide 25: Independent Medical Education Deepens Physician Engagement in aSAH Care
Independent Medical Education Deepens Physician Engagement in aSAH Care Reach & Independence Educational Impact • 7,181 total HCP learners engaged — including 434 neurosurgeons, 510 neuro critical care specialists, and 2,237 nurses (plus NPs, PAs, and pharmacists) • Relative increase in aSAH knowled
Slide 26: Concentration of aSAH Care – Efficient Commercialization
Concentration of aSAH Care – Efficient Commercialization Concentration of aSAH Patients aSAH-Treating Institutions Concentration Analysis includes n = 3,227 institutions where at least one aneurysmal SAH patient is treated 100% 80% 60% ~80% of aSAH patients % of Patients spread across 880 centers 40
Slide 27: Intellectual Property Portfolio
Intellectual Proper ty Portfolio Multi-layered intellectual property protection strategy GTx-104 received orphan drug status designation from the FDA • Potential 7 years of marketing exclusivity in US upon NDA approval US and international patent estate • Consists primarily of formulation and method
Slide 28: Capitalization
Capitalization Grace Therapeutics, Inc. (GRCE) Cap Table (as of August 11, 2026) Cash & Cash Equivalents Balance USD $22.2 M Outstanding Common Stock 21,035,930 Debt NONE Stock options granted and outstanding 1,345,453 Total Fully Diluted Shares Outstanding1 27,795,635 Potential Gross Proceeds from
Slide 29: Experienced Leadership Team
Experienced Leadership Team Management Team Prashant Kohli Loch Macdonald, MD, PhD Amresh Kumar, PhD Robert J. DelAversano Chief Executive Officer Chief Medical Officer VP Program Management Principal Financial Officer and Principal Accounting Officer Scientific Advisory Board Andrew Ducruet, MD Ale