Grace Therapeutics, Inc. · NASDAQ:GRCE
Grace Therapeutics — Acasti Pharma — IPO Roadshow (November 2017)
46 slides from Grace Therapeutics's IPO roadshow presentation, Nov 24, 2017
Slide 1: Company Overview November/December 2017
NASDAQ & TSX-V: ACST Company Overview November/December 2017 Issuer Free Writing Prospectus Filed Pursuant to Rule 433 of the Securities Act of 1933, as amended Registration Statement No. 333-220755 COMPANY OVERVIEW
Slide 2: Notices
Notices This presentation contains information that may be forward-looking statements within the meaning of applicable securities laws. Forward-looking statements can be identified by the use of terms such as “may”, “will”, “should”, “expect”, “plan”, “anticipate”, “believe”, “intend”, “estimate”, “
Slide 3: Overview of Acasti Pharma
Overview of Acasti Pharma 3 Biopharmaceutical company: spun out of Neptune Technologies in 2008 to develop innovative drugs for cardiometabolic diseases Headquartered in Montreal, Quebec, Canada Listed as ACST on TSXV and NASDAQ: first public offering late 2013 Phase 3-ready lead drug candidate, CaP
Slide 4: Offering Summary
Offering Summary Offering Type: Follow-On NASDAQ/TSX-V Symbol: ACST 11/22/2017 Stock Price: Anticipated Gross Proceeds: $15.0 Million Use of Proceeds: Further development of CaPre; expansion of business development activities; working capital; and other general corporate purposes Joint Book Running
Slide 5: Key Investor Considerations
Key Investor Considerations $2.3 Billion Global Prescription OM3 Market, $750M in the US (2015) Five million scripts written annually, only two branded competitors with ~ 30% price differential with generics CaPre’s initial indication targets 3 - 4M patients with severe HTG in the US Underserved Mar
Slide 6: Recent Developments
Recent Developments Execution of non-binding term sheet with a leading Chinese pharmaceutical partner: Term Sheet contemplates payments to Acasti of: Completion of transaction subject to further negotiation and execution of definitive agreement US$8.0 million upon signing Potential additional regula
Slide 7: Hypertriglyceridemia is a Large and Undertreated Problem
Hypertriglyceridemia: Levels elevated >150 mg/dL 40M people in US have TG levels >200mg/dL and should be treated ~4M people in US w/TG levels >500mg/dl (CaPre’s first indication) at greater risk of diabetes, heart disease, renal failure, and pancreatitis Hypertriglyceridemia is a Large and Undertrea
Slide 8: CaPre's Novel Formulation Combines Phospholipids and Free Fatty Acid Forms of EPA and DHA
CaPre’s Novel Formulation Combines Phospholipids and Free Fatty Acid Forms of EPA and DHA A novel formulation of polyunsaturated fatty acids, primarily OM3s (principally EPA and DHA), delivered as phospholipid esters and free fatty acids for rapid absorption Essential components are extracted and pu
Slide 9: CaPre's Phospholipid Free Fatty Acid Composition Delivers Superior Absorption
CaPre’s Phospholipid Free Fatty Acid Composition Delivers Superior Absorption vs. Competitor Rx OM3s Prescription OM3s Are Poorly Absorbed with Low Fat Diet Potent Composition, Efficient Absorption Advantage: CaPre has no food effect But, esterified OM3s have a significant food effect – require a hi
Slide 10: Therapeutic (Rx) OM3 Fish Oil Competitors
Therapeutic (Rx) OM3 Fish Oil Competitors Like CaPre, all competitor OM3 Rx products effectively reduce TGs, however there are important differences: • LOVAZA and VASCEPA OM3s are “esterified” and require a high fat content meal for optimal absorption EPANOVA OM3s are delivered as free fatty acids,
Slide 11: Prescription OM3s: Higher Purity and Potency Compared to Dietary Supplements
Prescription (Rx) OM3s: Much Higher Purity and Potency Compared to Dietary Supplements (DS) DS OM3 differ from Rx OM3s in significant ways: DS often contain triglycerides; not recommended for HTG patients DS may contain other impurities, and relative safety is unknown DS contain significantly lower
Slide 12: CaPre Has Been Studied in Patients and is Phase 3 Ready
CaPre Has Been Studied in 773 Patients to Date and is Phase 3 Ready Good bioavailability even under fasting conditions, no significant food effect Significantly lowers triglycerides (TGs) and non-HDL-C No deleterious effects on LDL-C (“bad cholesterol”); potential to reduce LDL-C Potential to increa
Slide 13: CaPre May Deliver a More Complete Lipid Management Solution
CaPre May Deliver a More Complete Lipid Management Solution for Patients with Severe HTG¹ EPA + DHA Omega-3LOVAZA Ethyl Esters & Generics Significant EPA + DHA Omega-3EPANOVA Free Fatty Acids None ¹ In Phase 2 clinical studies, CaPre showed positive effects on TGs, HDL-C and non-HDL-C, and no delete
Slide 14: Phase 3 Program: Expected to Reduce Time, Cost and Risk
Phase 3 Program: Expected to Reduce Time, Cost and Risk Clinical program reviewed and clarified with FDA; site initiation expected by end of 2017 Long term (1 year) safety data not required – PK safety bridge successfully established with LOVAZA, supporting 505(b)(2) pathway Two Phase 3 clinical stu
Slide 15: CaPre Could Fill a Significant Unmet Medical Need
CaPre Could Fill a Significant Unmet Medical Need Physicians interviewed said they would switch ~35 - 53% of their HTG patients within 2 years depending on the CaPre target profile tested¹ Low KOLs/HVPs were asked to assess the level of unmet medical need for treating patients with HTG based on curr
Slide 16: $2.3 Billion Global Rx OM3 Market for HTG
$2.3 Billion Global Rx OM3 Market for HTG1 LOVAZA GENERICS BRANDED VASCEPA BRANDED LOVAZA US Market - $750 Million3 $536M Global Market - $2.3 Billion2 $1.1B $750M $466M NORTH AMERICA EUROPE ASIA PACIFIC ¹ 2015 data expressed in US dollars 2 GOED proprietary research; Global EPA and DHA Pharmaceutic
Slide 17: Attractive US Rx OM3 Market for Treating HTG
Attractive US Rx OM3 Market for Treating HTG Large, underserved market; HTG affects ~one-third of the U.S. population1 Only 3.6% of patients with TG ≥ 200 mg/dl are treated with TG lowering meds1,2 ~5 million scripts written each year2 Only two marketed branded competitors (LOVAZA & VASCEPA) LOVAZA
Slide 18: Opportunity May Exist for OM3 Market Expansion
Opportunity May Exist for OM3 Market Expansion Diabetes Epidemic Obesity Epidemic Aging US Population Evidence suggests potential for OM3s in other cardiometabolic indications 1Qualitative market research with Key Opinion Leaders (KOLs) and High Volume Prescribers (HVPs) conducted for Acasti in Augu
Slide 19: Acasti's Strong and Growing IP Portfolio
Acasti’s Strong and Growing IP Portfolio Patent “Concentrated Therapeutic Phospholipid Composition” has been filed in 24 jurisdictions including Europe, North America, Asia, and Australia: Broad “Composition of Matter” claims allowed comprising phospholipid content between 60% - 99% “Method of Treat
Slide 20: cGMP Manufacturing Process Has Been Scaled
cGMP Manufacturing Process Has Been Scaled to Meet Projected Early Commercial Forecasts CaPre is manufactured under strict cGMP as per 21 CFR parts 210 and 211: RKO NKPL66 (Drug substance) Extraction, Decantation CaPre (Drug product) Encapsulation & Banding Packaging: Blisters and Bottles Clinical /
Slide 21: CaPre Development Timeline and Key Milestones
CaPre Development Timeline and Key Milestones 2016 2017 2018 2019 2020 2021 2022 Mfg Scale-up and Clinical Study Planning FDA Mtgs Conduct Two Phase 3 Trials (Double Blind, Placebo Controlled) Initiate cGMP Clinical Lot Builds File IND amendment and initiate sites Enroll patients End Enrollment End
Slide 22: Strengthened Acasti Leadership Team
Strengthened Acasti Leadership Team Board of Directors Rick Schottenfeld Director Dr. Roderick Carter, MD Chairman of Board Senior Management John Canan Audit Committee Chair Jan D’Alvise President & CEO, Acasti Katherine Crewe Director Jan D’Alvise President & CEO Linda O’Keefe, CPA CFO Pierre Lemi
Slide 23: Acasti Pharma Inc. Cap Table as of November 20, 2017
Acasti Pharma Inc. Cap Table as of November 20, 2017 Acasti Corporate Snapshot Common Shares Exchange/Ticker : NASDAQ/TSXV: ACST 14.7M Convertible Debt Equivalent Shares Stock Price Nov 22nd: US $2.04 1.1M Allocated Stock Options 52 Wk High/Low: US $3.36 – US $1.11 2.4M Unallocated Stock Options Mar
Slide 24: Why Invest in Acasti?
Why Invest in Acasti? Highly Differentiated and Proprietary Asset Targets “Trifecta” effect on blood lipids, and no food effect Strong and growing IP portfolio Developing global partnering opportunities Well Positioned Experienced and Accomplished Management, Board of Directors and Scientific Adviso
Slide 25: Clinical Data Summaries
Clinical Data Summaries COMPANY OVERVIEW
Slide 26: Why CaPre Does Not Have a Significant Food Effect Compared to Ethyl Esters
Why CaPre Does Not Have a Significant Food Effect Compared to Ethyl Esters (EE) Fatty acid Ethyl Ester Ethyl Ester Fatty acid Fatty acid glycerol PO4 Choline Fatty acid Phospholipid Free Fatty acid Ethyl Esters (LOVAZA, VASCEPA) Hydrolysis is mediated by carboxyl ester lipase (CEL), a bile-salt depe
Slide 27: Successful Phase 1 and Phase 2 Studies Reduce Phase 3 Program Risk
Successful Phase 1 and Phase 2 Studies Reduce Phase 3 Program Risk Clinical Studies Completed # Patients Enrolled 2013 2014 2015 2016 Phase 1 (PK) Single & mutiple doses Phase 2 (COLT) Safety & efficacy HTG Open-label, 8-week Phase 2 (TRIFECTA) Safety & efficacy HTG Double-blind, 12-week Phase 1 (PK
Slide 28: Single Dose Comparative Bridging Study Achieved All Objectives
Single Dose Comparative Bridging Study¹ Achieved All Objectives: Results Expected to Support 505(b)(2) Regulatory Pathway ¹ PK Bridging Study Protocol: 2016-4010: A Single-Dose, Comparative Bioavailability Study of CaPre 1 g Capsules Compared to LOVAZA 1 g Capsules Under Fasting and Fed Conditions B
Slide 29: CaPre Contains 2.5 Times Less EPA and DHA Compared to LOVAZA
CaPre Contains 2.5 Times Less EPA and DHA Compared to LOVAZA, and Yet Reaches Similar Blood and Therapeutic Levels Baseline-adjusted Plasma Concentration (nmol/mL) 0 100 200 300 CaPre (4 grams/day x 14 days on a low fat meal) Time (hour post-dose) 024681012141618202224 CAP13-101 Final study report,
Slide 30: CaPre Single and Multiple Dose Pharmacokinetics: No Significant Food Effect
CaPre Single and Multiple Dose Pharmacokinetics No Significant Food Effect¹ The bioavailability of CaPre (total EPA+DHA) does not appear to be meaningfully affected by the fat content of a meal after multiple daily doses @4g/day (< 20% difference in AUC) Baseline-adjusted Plasma Concentration (nmol/
Slide 31: Phase 2 Study Results Show CaPre Dose Response
Phase 2 Study Results¹ Show CaPre Dose Response and Potential for Trifecta Lipid Effect * Indicates results reached statistical significance ¹ COLT and TRIFECTA study data (TG population in mild to moderate is 90%. About 10% were severe. Only 30% of all patients were on statins). TRIFECTA for 1g (N=
Slide 32: Sub-Group Analysis in Patients with Severe HTG
Sub-Group Analysis in Patients with Severe HTG: CaPre¹ at 1 & 2 Grams Compares Well with Competition² at 2 & 4 Grams *Indicates results reached statistical significance ¹ Subgroup analysis on CaPre® Phase 2 TRIFECTA study data in patients with severe HTG; (N=10 for 1g & N=14 for 2g). Results are not
Slide 33: Subgroup Analyses in Patients Treated with Statins
* Indicates results reached statistical significance ¹ CaPre subgroup analyses on patients treated with statins: TRIFECTA for 2g (N=39) and COLT for 4g (N=22). For CaPre 2g, results for LDL-C, HDL-C, and non HDL-C are based on descriptive statistics only (no statistical testing was conducted). For C
Slide 34: Phase 3 Primary Endpoint and Study Design
PRIMARY ENDPOINT: To determine the efficacy of CaPre 4g daily, compared to placebo, in lowering fasting TG levels in subjects with fasting TG levels ≥500 mg/dL and ≤1500 mg/dL (≥5.7 mmol/L and ≤17 mmol/L) STUDY DESIGN: 4–6 WEEK SCREENING PERIOD V1 V2 V3 4 weeks if no change 1 week 2–3 WEEK TG QUALIF
Slide 35: Rationale Supporting Likelihood of Positive CV Outcome Trials with OM3s
Rationale Supporting Likelihood of Positive CV Outcome Trials with OM3s Focus for decades was on LDL, and then on HDL as keys to reducing CVD risk Association between LDL and CVD, and benefits of LDL reduction are well established However, a significant residual coronary risk remains after statin tr
Slide 36: REDUCE-IT Has Several Design Advantages Compared to JELIS
REDUCE-IT Has Several Design Advantages Compared to JELIS REDUCE-IT population is sicker vs JELIS: TG mean/median of 200 for REDUCE-IT vs 150 for JELIS HDL expected to be lower in REDUCE–IT (<40 mg/dL in 50% of patients) Patients enrolled have established CVD or at risk for CVD (Diabetes + risk fact
Slide 37: Reducing TGs in Patients Taking Statins with Low HDL Suggests Added CAD Benefit
Reducing TGs in Patients Taking Statins with Low HDL Levels and TG Levels >200mg/dl, Suggests Added CAD Benefit Trial/Date Published TG Therapy Subgroup Size (N) Statin Use Subgroup Data Published Endpoints Subgroup RRR (p-value) JELIS 2007 EPA only (Epadel) 957 Yes TG >150 mg/dl HDL <40 mg/dl Expan
Slide 38: Positive Outcome Trials Could Be Major Catalyst for OM3 Market Expansion
Positive Outcome Trials Could Be Major Catalyst for Significant OM3 Market Expansion If results of one or both of these two independent studies are positive, they could be significant value drivers for Acasti, especially if CaPre Phase 3 program confirms “best-in-class” effect on all major blood lip
Slide 39: Appendices
Appendices COMPANY OVERVIEW
Slide 40: Scientific Advisors and Key Clinical/Regulatory Collaborators
Scientific Advisors and Key Clinical/Regulatory Collaborators Robert Hegele, MD, FRCPC, FACP, FAHA, FCAHS Professor at Western University Director of London Regional Genomics Centre at Robarts Research Institute in London. Ont. Canada Robert H. Eckel, MD Charles A. Boettcher II Endowed Chair in Athe
Slide 41: Industry 101: Breakdown of the Science
Industry 101: Breakdown of the Science What is hypertriglyceridemia (HTG)? Hypertriglyceridemia is a condition in which there are excess or elevated triglyceride (TG) levels in the blood. In layman's terms this means that fat levels in the blood are elevated to dangerous levels, and even with diet a
Slide 42: An Industry Breakdown Continued
An Industry 101 Breakdown Continued… What role do OM3 fatty acids play? Clinical studies conducted with OM3 drugs showed their safety and efficacy in patients with HTG. For now, the FDA has approved OM3 drugs for the treatment of severe HTG. Outcome studies are currently ongoing to assess the safety
Slide 43: Schedule A – Market Research Methodology and Assumptions
SCHEDULE A – Market Research Methodology and Assumptions DP Analytics, A Division of Destum Partners (“Destum”), an independent market research firm, conducted a qualitative U.S. commercial and market assessment for Acasti dated August 19, 2016, which is referred to in this presentation as the “Prim
Slide 44: Schedule A – Market Research Methodology and Assumptions, Continued
SCHEDULE A – Market Research Methodology and Assumptions, Continued Based on the PBM interviews, Destum assumed CaPre would be viewed favorably by payers at launch (e.g. Tier 2 or 3 depending on payer plan, which is comparable to VASCEPA) Upon completion of the screening questionnaire and approval f
Slide 45: CaPre IP Status in the U.S.
CaPre® IP Status in the U.S. Claim Status Expiration Date Territories Additional protections could include NCE - exclusivity (5 years), Patent Term Restoration (PTR), etc... Granted Granted Pending TBD U.S. 15/258044 October 2030 October 2031 U.S. (8586567) U.S. (9475830) Method of Use Composition o
Slide 46: CaPre Ex-US IP Status
CaPre® Ex-US IP Status Claim COMPANY OVERVIEW Status Expiration Date Territories Granted Allowed Pending TBD TBD Argentina (20100104020) Brazil (1120120114786) Canada (2779162) Chile (01124-2012) China (201410490601.5) Hong Kong (13102756.5 and 15109467.8) India (4273/DELNP/2012) Japan (2015-081001)