Grey Matters Health Inc · CSE:GREY
Grey Matters Health — Algernon Pharmaceuticals — Investor Presentation (March 2023)
40 slides from Grey Matters Health's investor presentation, March 2023
Slide 1: Algernon Pharmaceuticals Q1 2023
CSE : AGN | O T C Q B : AGN PF | X F RA : AGW0 Q1, 2023 C SE : A G N | OTCQB: AGNPF | XFRA: AGW
Slide 2: Disclaimer
DISCLAIMER Certain statements in this presentation (the “Presentation”) are forward-looking statements, which are made as of the date of this Presentation or as of the date of the effective date of information described in this presentation, as applicable. Forward-looking statements relate to future
Slide 3: Disclaimer (cont.)
DISCLAIMER (cont.) This Presentation provides general background information about the activities of Algernon. The Presentation also contains projections and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry and our busi
Slide 4: Algernon is a Clinical Stage Drug Development Company
BUSINESS MODEL ALGERNON MODEL Algernon is a Clinical Stage Drug Development Company Global Disease Indications – Unmet Needs CSE:AGN | OTCQB: AGNPF | X F R A : AGW0 4
Slide 5: Algernon is Advancing 3 Drugs
BUS I N E S S M O D E L Algernon is Advancing 3 Drugs NP–120 (Ifenprodil): Idiopathic Pulmonary Fibrosis and Cough Repurposed AP-188 (DMT): Psychedelic Drug – Stroke Naturally Occurring NP-251 (Repirinast): – Chronic Kidney Disease Repurposed CS E : AG N | OT C : A G N PF | XF R A : AG W 0 5
Slide 6: Drug Repurposing is the Process of Discovering New Therapeutic Uses for Approved Drugs
BUSINESS MODEL ALGERNON MODEL *Drug Repurposing is the Process of Discovering New Therapeutic Uses for Approved Drugs RISK REDUCTION – CAPITAL EFFICIENT – SHORTER DEVELOPMENT PATHWAY * Drugs Not Approved or Marketed in U.S.or Europe. CS E : AG N | OT C : A G N PF | XF R A : AG W 0 6
Slide 7: New Chemical Entity Development Pathway and Failure Rates
N EW CHEMICAL ENTITY (NCE) DEVELOPMENT PATHWAY AND FAILURE RATES 90% 34% 51% 41% FA I L U R E FA I L U R E FA I L U R E FA I L U R E PRE-CLI N I C AL PHASE I PHASE II PHASE III MARKET Many Phase II & III trial failures due to non-efficacy issues. Efficacy Safety Strategic PK Commercial Not financial
Slide 8: Drug Repurposing: Case Studies
BUS I N E S S M O D E L DRUG REPURPOSING: CASE STUDIES COMPANY DRUG OLD INDICATION N E W INDICATION NOTES - Drug Only Approved in Germany (50 yrs) BIOGEN Tecfidera Psoriasis Multiple sclerosis - Blockbuster (>US$1B in Sales) - Drug wasWithdrawn from the Market Morning - Blockbuster (>US$1B in Sales)
Slide 9: Algernon Pharmaceuticals Lead Drug Candidates
ALGERNON PHARMACEUTICALS LEAD DRUG CANDIDATES 9
Slide 10: Lead Drug: NP-120 (Ifenprodil)
LEAD DRUG: NP-120 (IFENPRODIL) Prior / Existing Our Current Sales / Market Indications Indications Therapies Size Idiopathic Pulmonary Fibrosis • Peripheral Arterial • Ofev (Nintedanib) • Ofev - $2.28B(1) Obstructive Disease • Esbriet (Pirfenidone) • Esbriet - >$1B(2) (France until 2015) Phase 2 • V
Slide 11: IPF – Bleomycin Animal Study
IPF – BLEOMYCIN ANIMAL STUDY FIBROSIS • N=10 / Arm REDUCTION(TRICHROME) • Treatment Day 7-21 • Clinically Relevant Doses 55.3% p = 0.015 43.9% 50.6% p = NS p < 0.05 IFENPRODIL PIRFENIDONE NINTEDANIB (4mg/kg) TID (100mg/kg) BID (60mg/kg) QD C S E : AG N | OT C : A G N P F | X F R A : AG W0 11
Slide 12: Mechanism of Action – Cough
MECHANISM OF ACTION – COUGH CLINICAL CANDIDATES 12
Slide 13: Acute Cough – Citric Acid Model Study
ACUTE COUGH – CITRIC ACID MODEL STUDY • Acute Guinea Pig Citric Acid Model • (n=6/arm) Using Clinically Relevant Doses of Ifenprodil and Gefapixant Data – Cough Count • Ifenprodil = 42% Reduction (p < 0.01) • Gefapixant† = 20% Reduction (p < 0.05) †Unlike Gefapixant, Ifenprodil Has No Effect on Tast
Slide 14: Acute Cough – Citric Acid Model Study: Onset of First Cough
ACUTE COUGH – CITRIC ACID MODEL STUDY Data – Onset of First Cough (Seconds) • Ifenprodil = 75% Delay (p < 0.05) • Gefapixant = 45% Delay (p = NS) *p<0.05 compared to placebo C S E : AG N | OT C : A G N P F | X F R A : AG W0 14
Slide 15: IPF & Cough Experts
IPF & COUGH EXPERTS Dr. Martin Kolb MD, PhD Dr. Jacky Smith, MB, ChB, FRCP, PhD Dr. Peter Dicpinigaitis, MD, FCCP CS E : AG N | OT C : A G N PF | XF R A : AG W 0 15
Slide 16: AGN-120-1: Phase 2a Clinical Trial in IPF & Chronic Cough
AGN-120-1: PHASE 2a CLINICAL TRIAL IN IPF & CHRONIC COUGH • 20 Patient Open-Label IPF Patients With Cough • 12 Weeks of Treatment, 20 mg Ifenprodil 3 x per day • Endpoints: ü Primary for Cough: Reduction in 24-hour and Waking Cough Counts vs. Baseline, Measured by Ambulatory Cough Monitor ü Primary
Slide 17: IPF – Lung Function Data
IPF – LUNG FUNCTION DATA • 13/20 Patients (65%) in the Intent-to-Treat Set Experienced 120 Baseline Week 12 Error bars represent SD no Worsening of FVC (Co-primary Endpoint, p=0.0225). 100 This Was Superior to a Hypothesized Placebo Effect of 40% (Taken From Clinical Trials of Pirfenidone1 and Exper
Slide 18: IPF – Patient Quality of Life
IPF – PATIENT QUALITY OF LIFE 100 Error bars represent SD • Quality of Life was Measured using the King’s Brief 90 King’s brief interstitial lung disease Interstitial Lung Disease Questionnaire. 80 68.54 70 • Patients Report Symptoms on a 7-Point Likert Scale, and questionnaire score 60.76 60 Answer
Slide 19: Cough - Response Rates
COUGH - RESPONSE RATES 100% • 6/20 Patients (30%) in the Intent-to-Treat Set 90% Proportion of subjects achieving outcome Experienced a >50% Reduction in Cough at 12- 80% 75% weeks (Co-primary Endpoint). This Was Not 70% Significant Compared to a Hypothesized Placebo 60% 55% Effect of 25% (Selected
Slide 20: Cough – Geometric Mean Cough Counts
COUGH – GEOMETRIC MEAN COUGH COUNTS • “These data are quite compelling… To see effects of this magnitude in an IPF population, where other drugs have failed to demonstrate a benefit, is notable…” Dr. Jacky Smith, Manchester University • “The NMDA receptor is a fascinating target, and Ifenprodil, if
Slide 21: Cough – Quality of Life
COUGH – QUALITY OF LIFE 21.00 19.00 Baseline Error bars represent SD • Quality of Life was Measured with the Leicester Cough 17.00 Questionnaire. Leicester cough questionnaire score Week 12 15.81* 15.00 14.06 • Patients answer Questions in Three Domains, Each Scored 13.00 from 1 – 7; Domains are Sum
Slide 22: Cough – Quality of Life
COUGH – QUALITY OF LIFE Cough VAS Global Rating of Change 90 70% • Cough VAS, a Patient-Reported Measure 80 Proportion of subjects achieving outcome 60% 58% of Cough Severity, was Improved by 70 63.1 50% Cough severity VAS (mm) 37.4% (23.6 mm, p – 0.001). 17 mm is 60 regarded as the MCID in acute co
Slide 23: Safety
SAFETY • The Adverse Events Observed in this Trial were Consistent with the Clinical History of NP-120, Established in Post-Marketing Surveillance of over 8,000 Patients. • The Majority of AEs were Mild or Moderate in Severity. • The Most Commonly Observed Treatment Related TEAEs in the Study were G
Slide 24: Next Step Phase 2b Refractory Cough Trial
NEXT STEP PHASE 2B REFRACTORY COUGH TRIAL • Multinational, Three-arm, Randomized, Double-blind, Placebo-controlled Trial to Evaluate Ifenprodil in Approximately 180 patients with Refractory Chronic Cough • 3 Arms: Ifenprodil Low Dose, High Dose and Placebo • 12 Weeks Treatment • Primary Endpoint: Re
Slide 25: Public Company Comparables for Chronic Cough
PUBLIC COMPANY COMPARABLES FOR CHRONIC COUGH • Announced Positive Interim Phase 2b Results; Acquired by Merck and Co. for $1.25B • Positive Phase 2b Results: Current Market Cap of $1B CS E : AG N | OT C : A G N PF | XF R A : AG W 0 25
Slide 26: Regulatory Status and Intellectual Property
REGULATORY STATUS AND INTELLECTUAL PROPERTY CHRONIC COUGH • Patents Pending in Canada, US, EU, Japan and China (Int’l Priority Date: Mar 6, 2020) • FDA Responses Received on Pre-IND Filing; Agency Agrees with Proposed Study Design IPF • Granted Patent for Treatment of IPF with Ifenprodil in Canada (
Slide 27: AP-188 (N,N-Dimethyltryptamine) DMT
AP-188 (N,N-DIMETHYLTRYPTAMINE) DMT Prior / Existing Our Current Sales / Market Indications Indications Therapies Size • None • Tissue Plasminogen • Global Stroke Activator (“TPA”) Treatment Market is Expected to Reach a • Surgical removal of Value of ~ US 15B by blockage the Year 2027(4) (“thrombec
Slide 28: DMT Stroke Program Preclinical Data
DMT STROKE PROGRAM Preclinical Data • InVitro Research Shows DMT has Neuroplastic and Neurogenesis Effects in Cortical Neuron Assay(7) • Research Confirms Sub-psychedelic Dose Active in Depression and Anxiety Model(8) • DMT was Effective in an Animal Stroke Study(9) (7) Olsen in vitro study:Cell Rep
Slide 29: DMT Promotes Neuritogenesis and Synaptic Growth
CL I N I CA L P RO G RA M S – OV ERV I EW DMT PROMOTES NEURITOGENESIS AND SYNAPTIC GROWTH • Psychedelics Increased Dendritic Arbour Complexity After 72 Hr Treatment InVitro(10) (10) Olsen in vitro study:Cell Reports (2018) 23:3170-82 CS E : AG N | OT C : A G N PF | XF R A : AG W 0 25
Slide 30: DMT Stimulates Neuritogenesis Through BDNF
CL I N I CA L P RO G RA M S – OV ERV I EW DMT STIMULATES NEURITOGENESIS THROUGH BDNF • When Cortical Neurons Were • Application of BDNF to Treated With DMT for 24 HR Cortical Neurons Showed a a 2X Increase in BDNF Protein Dose-Dependent Response on was Observed. Neuritogenesis. CS E : AG N | OT C :
Slide 31: DMT Stroke Preclinical In Vivo
DMT STROKE PRECLINICAL IN VIVO • Transient (60 Min) MCAO was Applied to Male Wistar Rats. • DMT was Infused Immediately Before Removal of the Filament and Continued for 24 Hr. • Individual T2 Lesion Volumes 24 Hr After MCAO Were Significantly Lower in DMT Treat Animals Compared to Controls and Anima
Slide 32: DMT Stroke Program
DMT STROKE PROGRAM ü IP Filed for New Salt Forms of DMT, Dosing, Formulation, Method of Use and Combination Therapy for Stroke Rehabilitation. ü Algernon has Received Approval to Conduct a Phase I Clinical Study of Intravenous Formulation of DMT for the Treatment of Stroke in the Netherlands. ü Phas
Slide 33: DMT Stroke Program Phase 1 Study
DMT STROKE PROGRAM PHASE 1 STUDY • Up to 60 Healthy Volunteers - Psychedelic Experienced and Psychedelic Naïve Patients. • Identify Safety, Tolerability, and Pharmacokinetics of DMT - Intravenous Bolus Followed by Prolonged Infusion for Durations Which Have Never Been Studied Clinically. • Study Pha
Slide 34: DMT Stroke Program Experts
DMT STROKE PROGRAM EXPERTS Dr. David Nutt DM, FRCP, FRCPYCH, FSB, FMEDSCI Dr. Rick Strassman MD Author of the book DMT: The Spirit Molecule (2001) CS E : AG N | OT C : A G N PF | XF R A : AG W 0 34
Slide 35: NP-251 (Repirinast)
NP-251 (REPIRINAST) Prior / Existing Our Current Sales / Market Indications Indications Therapies Size • Sold for 25 years in • Focus on managing • CKD market Japan under Romet™ symptoms and opportunity expected for Asthma complications that to reach $15.8B by include high blood 2024(11) • Pediatric
Slide 36: Chronic Kidney Disease – UUO Model Study
CHRONIC KIDNEY DISEASE – UUO MODEL STUDY 2 U N I L AT E R A L U R E T E R FIBROSIS REDUCTION(SIRIUS RED) OBSTRUCTION MODEL 54.2% 50.6% p < 0.000001 • N=10 / Arm p<0.000001 • Start Treatment Day 0-14 • Post Bonferroni Corrected • Reduction in Fibrosis vs Negative Control • Once a Day (QD) Treatment 3
Slide 37: Upcoming Milestones & Potential Catalysts
UPCOMING MILESTONES & POTENTIAL CATALYSTS Q1 2023 Q2 2023 Q3 2023 Q4 2023 CHRONIC COUGH US FDA IND Filing Begin Phase 2b Study US FDA IND filing / Fast IPF Track Application DMT / STROKE Began Phase 1 Study Phase 1 DMT Data Begin Phase 2 CKD Complete Manufacture Begin Phase 1 Study 37
Slide 38: Clinical Trial Experienced Management Team
CLINICAL TRIAL EXPERIENCED MANAGEMENT TEAM Christopher J.Moreau Dr. Christopher Bryan,PhD James Kinley,CPA,CA C H I EF EX EC U T I V E O F F I C E R V P R E SE A R C H A N D O P E R A T I O N S C H I EF FI N A N C I A L O FFI C ER • President, CEO & director of a TSX:V listed • Graduated from the Un
Slide 39: Balance Sheet & Capitalization
BALANCE SHEET & CAPITALIZATION Estimated Cash (as of March 9 , 2022) th $0.3M CDN Debt (as of March 9 2022) th - Capitalization Common Stock Equivalents Common Stock 9,653,656 Warrants (WAEP $2.05) 2,769,768 Options (WAEP $1.01) 931,000 RSU’s 780,004 Total Fully Diluted 14,134,428 Recent Share Price
Slide 40: CS E : AG N | O T C Q B : AG N
CS E : AG N | O T C Q B : AG N P F | X F RA : AG W0
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