Grace Therapeutics, Inc. · NASDAQ:GRCE
Grace Therapeutics — Acasti Pharma — Investor Presentation (April 2024)
18 slides from Grace Therapeutics's investor presentation, Apr 1, 2024
Slide 1: Company Overview April 2024
Company Overview NASDAQ: ACST April 2024
Slide 2: Forward Looking Statements
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, as amended,
Slide 3: Late-stage biopharma company poised to disrupt Standard of Care in aSAH
Late-stage, biopharma company poised to disrupt Standard of Care (SoC) in treatment of aneurysmal Subarachnoid Hemorrhage (aSAH) Summary GTX-104 – novel intravenous nimodipine – well positioned to solve oral challenges and potentially displace it as the SoC Nimodipine is the SoC and clinically de-ri
Slide 4: aSAH Overview
Sources: Fletcher Spaght market research report; Rinkel G. (2016); Becske T. (2018) Life threatening acute brain injury associated with high mortality and morbidity aSAH Overview Subarachnoid hemorrhage aSAH results in bleeding over the surface of the brain in the space between the brain and skull P
Slide 5: Substantial barriers to administering oral nimodipine
Soppi V. (2007); Abboud T. (2015); Connolly ES. (2012) Substantial barriers to administering oral nimodipine aSAH Current Standard of Care Current limitations Many aSAH patients are unconscious, cannot swallow oral medication - delivery via nasogastric tube often necessary, resulting in significant
Slide 6: GTX-104: Technology Overview
Potentially improve administration of nimodipine and better manage hypotension GTX-104 is a novel formulation of nimodipine for IV infusion in aSAH patients Overcomes solubility limitations of nimodipine in current formulations Patented formulation uses non-ionic surfactant micelles as the drug carr
Slide 7: GTX-104: Potentially Strong Value Proposition
GTX-104: Potentially Strong Value Proposition Nimodipine administration in aSAH patients is a key Joint Commission (JC) quality measure for hospitals with stroke certification Sources: Nimodipine capsule packaging insert; Fletcher Spaght market research report; Soppi V. (2007) Effective hypotension
Slide 8: GTX-104-002 Phase 1 Trial: Successful Proof of Concept
GTX-104-002 Phase 1 Trial: Successful Proof of Concept 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 Conclusions Results met the scientific bridge criteria (bioequivalence) of GTX
Slide 9: GTX-104-002 Phase 1: Results
GTX-104-002 Phase 1: Results Source: GTX-104-002 CSR; results announced May 2022 Established pharmacokinetic bridge with oral nimodipine GTX-104 is 100% bioavailable vs. 7.20% for oral Mean Plasma Nimodipine Concentration GTX-104 (IV) Nimodipine Capsules 90% Confidence Limits (%) PK Parameters Geome
Slide 10: GTX-104-002 Phase 1: Results
GTX-104-002 Phase 1: Results Source: GTX-104-002 CSR; results announced May 2022 Consistent, predictable plasma concentrations allow for tighter control of hypotension 37% 15% 37% 11% Significantly lower dose variability relative to oral capsule Consistent and predicable plasma concentrations GTX-10
Slide 11: GTX-104-002 Phase 1: Results
GTX-104-002 Phase 1: Results Demonstrated improved or comparable hypotension and safety profile Source: GTX-104-002 CSR; results announced May 2022 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
Slide 12: GTX-104 Next Steps: STRIVE-ON Pivotal Safety Trial
GTX-104 Next Steps: STRIVE-ON Phase 3 Pivotal Safety Trial DCI: delayed cerebral ischemia; mRS: modified Rankin Scale; C-SSRS: Columbia-Suicide Severity Scale First patient enrolled in Oct 2023 – potential NDA submission 1H 2025 STRIVE-ON (NCT05995405) is a 100-patient prospective, open-label, rando
Slide 13: aSAH Addressable Market
aSAH Addressable Market Sources: Fletcher Spaght market research report; Rinkel G. (2016); Becske T. (2018) ~$300 million US market opportunity ~50,000 individuals experience aSAH annually in US Average cost per patient hospital stay is ~$220,000, one of the most expensive acute conditions to treat
Slide 14: GTX-104 Market Opportunity
GTX-104 Market Opportunity Sources: January 2024 third-party market research survey targeting hospital decision makers view of GTX-104 Insights from Hospital Pharmacy & Therapeutics (P&T) Committee Decision Makers Survey Design 31 hospital administrators, critical and neuro intensive care physicians
Slide 15: Intellectual Property Portfolio
Strong and multi-layered intellectual property protection strategy Intellectual Property Portfolio GTX-104 received orphan drug status designation from the FDA Potential 7 years of marketing exclusivity in US upon NDA approval Strong US and international patent estate Consists primarily of compositi
Slide 16: Experienced Leadership Team
Experienced Leadership Team Proven drug development and commercialization expertise Carrie D'Andrea VP Clinical Operations Loch Macdonald, MD, PhD Chief Medical Officer Prashant Kohli Chief Executive Officer Amresh Kumar, PhD VP Program Management Brian Ford, CPA-CA CFO Robert J. DelAversano Princip
Slide 17: Financial Overview
Financial Overview * Pre-Paid Warrants, Common Warrants, and Outstanding Grants Acasti Pharma Inc. Cap Table (as of December 31, 2023) Cash Balance USD $25.1 M Common Shares 9,399,404 Debt NONE Stock options granted and outstanding 561,365 Total Fully Diluted Shares Outstanding (including unallocate
Slide 18: Acasti Contact
Acasti Contact: Prashant Kohli Chief Executive Officer Email: p.kohli@acasti.com Website: www.acasti.com Investor Contact: Mike Moyer LifeSci Advisors Email: mmoyer@lifescieadvisors.com