Grace Therapeutics, Inc. · NASDAQ:GRCE
Grace Therapeutics — Acasti Pharma — Merger or Acquisition (May 2021)
21 slides from Grace Therapeutics's merger presentation, May 7, 2021
Slide 1: Non-Confidential Information Presentation May 2021
1 Non - Confidential Information Presentation May 2021 DW1
Slide 2: Disclaimer
Disclaimer This presentation does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval . The proposed transaction will be submitted to the shareholders of Acasti Pharma Inc . (“Acasti”) for their consideration . Acasti will a
Slide 3: Forward-Looking Statements
Forward - Looking Statements This presentation contains forward - looking statements, which are protected as forward - looking statements under the Private Securities Litigation Reform Act of 1995 , that are not limited to historical facts, but reflect Acasti’s and Grace’s current beliefs, expectati
Slide 4: Transaction Highlights
Transaction Highlights » Acasti and Grace are a strong strategic fit: » Acasti gains a new pipeline of high potential clinical and preclinical programs » Acasti expands its expertise with Grace’s competencies in novel drug delivery technology and rare diseases » Combined company has significant drug
Slide 5: About Grace Therapeutics
About Grace Therapeutics » Leverage proprietary drug delivery capability and technologies to address rare and orphan diseases where there are significant unmet medical needs : » Focus on well - understood diseases that are poorly served by available therapies or have no approved therapies » Apply un
Slide 6: Grace's Lead Assets
Grace’s Lead Assets » GTX - 104: Subarachnoid Hemorrhage (SAH) – Intravenous Infusion » Disease Target : SAH is a rare and life - threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull » Product Description : Novel a
Slide 7: Near-Term Milestones for Lead Drug Candidates
Product Candidate Planned Regulatory Pathway Target Indication Near - Term Milestones GTX - 104 505(b)(2) Subarachnoid Hemorrhage (SAH) – ODD status granted • PK bridging study results expected Q1’22 • Start of Phase 3 safety study expected Q3’22 * GTX - 102 505(b)(2) Ataxia Telangiectasia (A - T) –
Slide 8: Subarachnoid Hemorrhage (SAH) Overview
Subarachnoid Hemorrhage (SAH) Overview Devastating neurological condition that can cause coma, paralysis and is often fatal SAH results in bleeding over the surface of the brain in the space between the brain and the skull A primary cause of such bleeding is rupture of an aneurysm ( aSAH ) The
Slide 9: GTX-104: Novel Nanoparticle Formulation for IV Infusion
9 GTX - 104: Novel Nanoparticle Formulation for IV Infusion 0 10 20 30 40 50 60 0 10 20 30 40 50 60 Plasma Concentration ng/mL Time (Hr) Nimodipine Plasma Concentration (GTX - 104 infusion 1.22 mg / hr vs Oral) GTX-104 Infusion 1.22mg/hr Oral Capsule 60 mg/4 hour Box and Whiskers Plot: AUC 12 - 16hr
Slide 10: GTX-104: Superior Value Proposition
10 GTX - 104: Superior Value Proposition Hospital Value x IV form is 100% bioavailable versus only 13% for oral x Potential to better manage hypotension x Reduced food effects and DDI x Reduced drug intake x Potentially Safer x Potentially improved outcomes x Convenient (2x vs 6x per day) x Potentia
Slide 11: Ataxia-Telangiectasia (A-T) Overview
11 Ataxia - Telangiectasia (A - T) Overview Existing Treatment s: Ataxia - Telangiectasia Complex genetic neurodegenerative disorder often diagnosed during infancy or early childhood Typically characterized by: Progressively impaired coordination Development of reddish lesions of the skin du
Slide 12: GTX-102: Targeted A-T Therapy with Indicative Clinical Data
GTX - 102: Targeted A - T Therapy with Indicative Clinical Data » GTX - 102 is a novel formulation of betamethasone intended to improve neurological symptoms of A - T: » Potential to decrease symptoms including posture and gait disturbance, as well as kinetic, speech and oculomotor functions » Conce
Slide 13: GTX-102: Zannolli Clinical Data
13 GTX - 102: Zannolli Clinical Data Clinical Study Results in A - T Patients Administered Oral Betamethasone Betamethasone significantly reduced ICARS* total score relative to placebo (P = .01). The median ICARS change score (change in score with Betamethasone minus change in score with placebo) wa
Slide 14: GTX-102: Nonclinical PK Comparison
14 GTX - 102: Nonclinical PK Comparison: Betamethasone Oral Spray (Grace) vs. Oral Solution Or al mucosal spray is equivalent at 1/70 th the volume of the o ral solution Note: Values are mean ± SD (% CV); [a] represents Median (minimum - maximum); ROA=Route of administration; CV=Coefficient of varia
Slide 15: Postherpetic Neuralgia (PHN)
15 Postherpetic Neuralgia (PHN) PHN is clinically defined as pain persisting 3 months or more after onset of rash • Leading cause of debilitating pain in elderly • 60% of PHN patients have pain that persists over a year • Half of patients describe their pain as “horrible” or “excruciating” • Many cl
Slide 16: GTX-101: Novel Thin Film Bioadhesive Bupivacaine Spray
16 GTX - 101: Novel Thin Film Bioadhesive Bupivacaine Spray • Metered - dose of bupivacaine spray forms a thin bioadhesive topical film : » Touch - free, non - greasy application » Convenient, portable 30mL plastic bottles • Biphasic delivery mechanism enables rapid onset and is expected to provide
Slide 17: GTX-101: Superior Value Proposition
Easier, more convenient application • Potential for rapid onset of action and extended relief • Easy to use (no peeling and cutting patches to size) • Ability to precisely cover the affected area • No skin sensitivity or irritation in Phase 1 trial • More potent analgesic and opioid - sparing • Well
Slide 18: Transaction Structure and Financial Highlights
18 Transaction Structure and Financial Highlights » Structure: Acquisition of Grace by Acasti via merger in a 100% stock transaction, with Grace becoming a direct wholly - owned subsidiary of Acasti » Ownership: Acasti shareholders owning 55% and Grace stockholders owning 45% of the combined company
Slide 19: Experienced Acasti/Grace Leadership Team
19 Experienced Acasti/Grace Leadership Team Pierre Lemieux, Ph.D. COO & CSO, Acasti Jan D’Alvise President & CEO, Acasti Prashant Kohli VP, Commercial Operations, Grace George Kottayil, Ph.D. CEO and Co - Founder of Grace Brian Ford CFO, Acasti
Slide 20: Grace Board of Directors
20 Grace Board of Directors Name & Title Biography Experience Vimal Kavuru, RPh Chairman & Co - Founder • Founder, Chairman & CEO of Rising Pharma Holdings, Inc., one of the top 20 US generic pharmaceutical companies. Previously, Mr. Kavuru was Founder of Citron Pharma & Lucid Pharma which were sold
Slide 21: Contact Information
Contact Information Acasti Contact: Jan D’Alvise Chief Executive Officer Tel: 450 - 686 - 4555 Email: info@acastipharma.com www.acastipharma.com Investor Contact: Crescendo Communications, LLC Tel: 212 - 671 - 1020 Email: ACST@crescendo - ir.com 21