Grace Therapeutics, Inc. · NASDAQ:GRCE
Grace Therapeutics — Investor Presentation (February 2025)
35 slides from Grace Therapeutics's investor presentation, Feb 10, 2025
Slide 1: Corporate Presentation February 2025
Corporate Presentation February 2025
Slide 2: Forward Looking Statements
Summary 2 Forward Looking Statements 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, a
Slide 3: Summary
Summary GTx-104 – novel intravenous nimodipine – well positioned to solve oral challenges and potentially displace oral as SoC Nimodipine is the SoC and clinically de-risked; however, significant unmet needs remain with its only available oral form Phase 3 STRIVE-ON safety trial supports GTx-104 ben
Slide 4: Experienced Leadership Team
Experienced Leadership Team 4 Carrie D'Andrea VP Clinical Operations Loch Macdonald, MD, PhD Chief Medical Officer Prashant Kohli Chief Executive Officer Amresh Kumar, PhD VP Program Management Robert J. DelAversano Principal Financial Officer and Principal Accounting Officer Alejandro A. Rabinstein
Slide 5: aSAH is a Rare and Severe Acute Brain Injury
aSAH is a Rare and Severe Acute Brain Injury Subarachnoid Hemorrhage aSAH results in bleeding over the surface of the 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 survival Patients require surgica
Slide 6: Oral Nimodipine – The aSAH Standard of Care for >3 Decades
Oral Nimodipine – The aSAH Standard of Care for >3 Decades 6 Sources: Hoh (2023). Hernandez-Duran (2019). Sandow (2016). DCI: Delayed Cerebral Infarction The Joint Commision is a hospital accredation agency 2023 AHA/ASA GuidelinesFor the management of patients with aSAH Nimodipine is the only approv
Slide 7: Nimodipine – Consistent Drug Administration Drives Positive Patient Outcomes
Nimodipine – Consistent Drug Administration Drives Positive Patient Outcomes 7 Sources: Hoh (2023). Hernandez-Duran (2019). Sandow (2016). aOR: adjusted odds ratio; CI: Confidence Interval Nimodipine cessation or dose reduction independently associated with poor functional outcomes (aOR 0.89, 95% CI
Slide 8: Substantial Shortcomings of Oral Nimodipine
8 Substantial Shortcomings of Oral Nimodipine Sources: Nimodipine Prescribing Label, Sandow et al., Mahmoud et al., Abboud et al., Soppi et al., Rabaut et al., Ho et al., Fletcher Spaght market research. Administration Challenges High dosing burden of 60mg (2 x 30mg capsules), 6 times per day 45% of
Slide 9: GTx-104 Technology Overview
GTx-104 Technology Overview Breakthrough formulation of GTx-104 is the result of a decade of research by Grace scientific team GTx-104 Drug Delivery Technology Drug loaded micelles Nimodipine 10– 15 nm Blank micelles Surfactant Monomers Hydrophilic Part Hydrophobic Part GTx-104 is a novel formulatio
Slide 10: GTx-104 Value Proposition
GTx-104 Value Proposition 10 Risk of Fatal Parenteral Use Requires Feeding Tube Excipient Intolerance Hemodynamic Control Dose Compliance Markets Nimodipine Capsules Yes Yes No Poor Poor U.S. / WW NYMALIZE (Oral Liquid) Yes (Reduced) Yes Yes Poor Poor U.S. / Select WW NIMOTOP (Injectable) No No Yes
Slide 11: GTx-104 Phase 1 Trial Summary
GTx-104 Phase 1 Trial Summary 11 Source: GTx-104-002 CSR; results announced May 2022. Cmax: Maximum observed concentration; AUC: Area under the Curve. The trial met all primary and secondary endpoints Achieved pharmacokinetic bridge of IV GTx-104 with oral nimodipine Bioavailability of GTx-104 was 1
Slide 12: GTx-104 Phase 1: Results
GTx-104 Phase 1: Results 12 Source: GTx-104-002 CSR; results announced May 2022 Consistent, predictable plasma concentrations allow for tighter control of hypotension Significantly lower dose variability relative to oral capsule Consistent and predictable plasma concentrations GTx-104 IV infusion vs
Slide 13: STRIVE-ON Phase 3 Trial
STRIVE-ON Phase 3 Trial
Slide 14: GTx-104 STRIVE-ON Phase 3 Pivotal Safety Trial Design
GTx-104 STRIVE-ON Phase 3 Pivotal Safety Trial Design 14 mRS: modified Rankin Scale STRIVE-ON (NCT05995405) is a ~100-patient prospective, open-label, randomized (1:1 ratio), parallel group trial of GTx-104 compared with oral nimodipine in patients hospitalized for aSAH Screening Period (within 96 h
Slide 15: Demographics & Baseline Characteristics
15 Demographics & Baseline Characteristics GTX-104 (N = 50) Oral Nimodipine (N = 52) Age (mean) 55 56 Sex, n (%) Female Male 33 (66.0%) 17 (34.0%) 33 (63.5%) 19 (36.5%) Hunt & Hess Grade, n (%) I II III IV V 10 (20%) 15 (30%) 15 (30%) 6 (12%) 4 (8%) 8 (15%) 15 (29%) 16 (31%) 12 (23%) 1 (2%) Demograp
Slide 16: Primary Endpoint – Clinically Significant Hypotension
16 Primary Endpoint – Clinically Significant Hypotension ~19% relatively fewer patients with clinically significant hypotension in GTx-104 GTX-104 (N = 50) n (%) Oral Nimodipine (N = 52) n (%) Clinically Significant Hypotension 14 (28%) 18 (35%) Clinically significant hypotension: decrease in systol
Slide 17: Relative Dose Intensity (RDI)
17 Relative Dose Intensity (RDI) 54% of patients on GTx-104 had RDI of 95% or higher versus 8% on Oral Nimodipine GTx-104 Oral Nimodipine RDI = (total dose administered / total amount of expected dose) * 100.
Slide 18: Clinical Outcomes – mRS (day 90)
18 Clinical Outcomes – mRS (day 90) ~29% relative increase in patients with good recovery in GTx-104 ~29% * 3 patients did not complete physician-conducted mRS at day-90. However, all 3 were confirmed alive at day-90 ** 6 patients did not complete physician-conducted mRS at day-90. 5 were confirmed
Slide 19: Clinical Outcomes – QoL (day 90)
19 Clinical Outcomes – QoL (Quality of Life; day 90) Patient-reported health scores favor GTx-104 QoL GTx-104 (N = 381) Oral Nimodipine (N = 402) Your Health Today Score mean (0 = being worst -> 100 = great) 75 70 Mobility, n (%) I have no or some problems I am confined to bed 38 (100%) 0 35 (88%) 5
Slide 20: Safety
20 Safety Overall safety was comparable between the two groups Summary of Adverse Events (AEs) (entire study duration of 90 days) GTx-104 (N = 50) Oral Nimodipine (N = 52) All AEs, n (%) # of events 44 (88%) 158 43 (83%) 193 All AEs, events per n 3.6 4.5 All SAEs1, n (%) # of events 18 (36%) 34 25 (
Slide 21: ICU Length of Stay, Mechanical Ventilator & Readmissions
21 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 (N = 50) Oral Nimodipine (N = 52) ICU los, days Mean (SD) 16.4 (6.7) 17.9 (10.4) Mechanical Ventilation days Mean (SD) 5.6 (5.7)
Slide 22: Pharmacoeconomics
22 Pharmacoeconomics Major patient resource utilization drivers in aSAH favor GTx-104 GTx-104 (N = 50) n* Oral Nimodipine (N = 52) 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 5 -38
Slide 23: Commercial Preparation
atest Commercial Preparation OD 3eBlace
Slide 24: aSAH Market Opportunity
~45% of treated patients are unconscious or dysphagic (nasogastric tube) >25% of treated patients have poor dose compliance / blood pressure control aSAH Market Opportunity 24 Literature, typically limited to basal cistern aSAH (~80% of aSAH), suggests ~42.5K U.S. hospital-treated patients Claims an
Slide 25: GTx-104 Market Research Survey
GTx-104 Market Research Survey Insights from hospital Pharmacy & Therapeutics (P&T) committee decision makers 31 hospital administrators, critical and neuro intensive care physicians at Comprehensive or Advanced Stroke Centers involved in purchasing decisions 20 respondents are current or former mem
Slide 26: Concentration of aSAH Care
Concentration of aSAH Care 26 aSAH-Treating Institutions Concentration PatientVolume Analysis includes n = 3,227 institutions where at least one aneurysmal SAH patient is treated Concentration of aSAH Patients % of Institutions % of Patients ~80% of aSAH patients spread across 880 centers ~15 rep sa
Slide 27: Intellectual Property Portfolio
Intellectual Property Portfolio 27 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-o
Slide 28: Closing Remarks
Closing Remarks
Slide 29: GTx-104 Conclusions & Next Steps
29 GTx-104 Conclusions & Next Steps Phase 1 trial met the scientific bridge criteria (bioequivalence) of GTx-104 with oral nimodipine – paving the way for pivotal safety trial and 505(b)2 pathway STRIVE-ON Phase 3 pivotal safety trial data suggest significant advantages vs oral nimodipine Primary en
Slide 30: GTx-102 Program Overview & Regulatory Update
30 GTx-102 Program Overview & Regulatory Update GTx-102 Novel oral spray formulation of betamethasone intended to improve neurological symptoms of A-T patients Proof of concept supported by well-controlled Phase 1 trial with A-T patients PK bridging study topline results announced on 12/18/22 met al
Slide 31: Appendix
— aa 4 Appendix
Slide 32: GTx-104 Patent Landscape: IV formulation
GTx-104 Patent Landscape: IV formulation 32 *Granted patent applications in Europe (validation completed in Austria, Belgium, Bulgaria, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Netherlands, Norway, Roman
Slide 33: GTx-104 Phase 1: Results
GTx-104 Phase 1: Results Established pharmacokinetic bridge with oral nimodipine Mean Plasma Nimodipine Concentration GTx-104 (IV) Nimodipine Capsules 90% Confidence Limits (%) PK Parameters Geometric Mean Geometric Mean Lower Upper C max Day_1 0-4 hr (ng/mL) 63.1 68.6 81.7 103.6 AUC Day_3 0-24hr (n
Slide 34: GTx-104 Phase 1: Results
GTx-104 Phase 1: Results Observed improved or comparable hypotension and safety profile 19 25 39 39 GTx-101 IV Nimodipine Capsules Hypotension 1 SBP <90 mmHg or DBP <60 mmHg Hypotension 2 SBP <90 mmHg or DBP <60 mmHg or decrease in SBP or DBP >10 mm Hg compared with baseline 34 Source: GTx-104-002 C
Slide 35: Thank You
Prashant KohliChief Executive Officer Thank You Grace Therapeutics Contact: Investor Contact: Mike MoyerLifeSci Advisors
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