Neurizon Therapeutics Limited · ASX:NUZ
Neurizon Therapeutics — PharmAust — Investor Presentation (August 2017)
36 slides from Neurizon Therapeutics's investor presentation, August 2017
Slide 1: Investor Presentation (August 2017)
For personal use only A Investor Presentation (August 2017) PharmAust Investor Presentation (Aug 2017) 1
Slide 2: Disclaimer
Disclaimer DISCLAIMER This presentation has been prepared by PharmAust Limited (ASX: PAA) (ACN: 094 006 023) (the “Company”). It does not purport to contain all the information that a prospective For personal use only investor may require in connection with any potential investment in the Company. Y
Slide 3: Corporate Structure
Corporate Structure For personal use only Epichem Pitney Pharmaceuticals PharmAust Investor Presentation (Aug 2017) 3
Slide 4: Corporate Overview
Corporate Overview For personal use only • PharmAust: Clinical-stage oncology company • Lead product is Monepantel (MPL) – a repurposed drug already approved for Veterinary use • PharmAust patented MPL as a novel anticancer drug • Unique clinical strategy targeting MPL for both human and vet applica
Slide 5: Corporate Snapshot
Corporate Snapshot ASX Code: PAA Total Shares on Issue 146,694,903 For personal use only Market Cap $10M Options (Unlisted) 42,547,078 Cash1 $2.59M Debt2 $0.5 Top 20 Own 35% Epichem Revenue $3.05M (FY17) Board/Exec Own 13% 1. As of 30 June, 2017 2. EFIC loan to Epichem: Mar 31, 2017 PharmAust Invest
Slide 6: Experienced Board & Management Team
Experienced Board & Management Team Dr. Roger Aston, Executive Chairman Dr. Wayne Best, Director For personal use only • >20 years experience in the pharmaceutical and • 30 years experience in synthetic and medicinal healthcare industries. chemistry in academia and industry. • Director or chairman o
Slide 7: Repurposing MPL for accelerated path to commercial returns
For personal use only Repurposing MPL for accelerated path to commercial returns PharmAust Investor Presentation (Aug 2017) 7
Slide 8: Drug Repurposing = Capital efficient path to market
Drug Repurposing = Capital efficient path to market For personal use only Typical Drug Development Phases Discovery Preclinical Phase I Phase 2 Phase 3 FDA Market 3-6 yrs 6-7 yrs 0.5-2 yrs 10+yrs. ~$1-2 billion Drug repurposing/repositioning 6yrs. ~$300 million Drug repurposing/repositioning 3-5yrs.
Slide 9: Value can be unlocked early in development cycle
Value can be unlocked early in development cycle For personal use only Discovery Preclinical Phase 1 Phase 2 Phase 3 Market Average upfront human oncology licensing deal values at different development stages (US$millions) 120 102 100 78 80 60 45 40 22 20 0 Preclinical Phase 1 Phase 2 Phase 3 Av Upf
Slide 10: Monepantel Oncology Programme: Progressing towards key clinical and commercial catalysts
For personal use only Monepantel Oncology Programme: Progressing towards key clinical and commercial catalysts PharmAust Investor Presentation (Aug 2017) 10
Slide 11: MPL targets the mTOR pathway: common to many cancers
MPL targets the mTOR pathway: common to many cancers Two complexes of mTOR For personal use only (mammalian target of rapamycin) mTORC1 mTORC2 s6K 4EBP Akt eIF4E Increased Expression CANCER! Cell Growth Cell Proliferation Cell Survival Saxton, R. A., & Sabatini, D. M. (2017). mTOR Signaling in Growt
Slide 12: >$2 Billion market for approved mTOR Drugs
>$2 Billion market for approved mTOR Drugs For personal use only Drug Approved Indications Company 2016 Sales (US$m)1 Sirolimus Transplantation Pfizer 170 Transplantation Renal Cell Carcinoma Rapalogues Breast Cancer Novartis/Pfizer >2,000 (Affintor/Torisel) Pancreatic Neuroendocrine Tumours Mantle
Slide 13: PharmAust's strong MPL patent position
PharmAust’s strong MPL patent position For personal use only • > 47 patents and patent applications • 5 patent families • Granted patents in US, Aus, China, NZ and Europe • Broad 'method of use’ for MPL across cancer and non-cancer applications • Joint portfolio of MPL analogues (composition of matt
Slide 14: Why MPL for Cancer: Comprehensive Preclinical Data-pack
Why MPL for Cancer For personal use only In vitro: MPL kills wide range of cancer cell lines MPL Approved for Animal Health In vivo: MPL monotherapy inhibits tumours in mice xenografts (pancreatic, ovarian, colorectal) In vivo: MPL combined with front-line drugs improves potency in mouse xenografts
Slide 15: Recent clinical outcomes promote commercial opportunities
Recent clinical outcomes promote commercial opportunities For personal use only Phase II pilot lymphoma trial in dogs MPL used as front-line therapy • 1st report of MPL clinical tumour inhibition Preliminary Results: ¾ (75%) treated dogs showed stable disease and tumour reduction • 1st report mTOR d
Slide 16: MPL Achieved Key Preclinical and Phase I Clinical Endpoints
MPL Achieved Key Preclinical and Phase I Clinical Endpoints For personal use only 1. Safety: Excellent safety profile in dogs & man as predicted by pre-clinical models 2. Efficacy: Observed reduction of key cancer biomarkers (p70s6K and p4E-BP-1) and reduction in tumours in dogs (3/4) diagnosed with
Slide 17: Strategy to develop MPL as a Cancer Therapeutic
Strategy to develop MPL as a Cancer For personal use only Therapeutic for: - Veterinary Health - Humans PharmAust Investor Presentation (Aug 2017) 17
Slide 18: Rationale for dual clinical development strategy
Rationale for dual clinical development strategy 70% oncology drugs fail in clinical trial due to: For personal use only • Poor Efficacy • Poor Safety Mouse Cancer Model Human Clinical Trial Mouse cancer models often poor Traditional Development Path predictors of drug activity in humans Mouse Cance
Slide 19: Rationale for dual clinical development strategy
Rationale for dual clinical development strategy Vet Oncology Development Human Oncology Development For personal use only Canine Outcomes Informs Human Clinical Development Efficacy Pharmacology Generates high quality preclinical data-pack Preclinical Models Biomarkers Combination therapy Clinical
Slide 20: Trends in Companion Animal Health Market (US:2016)
Trends in Companion Animal Health Market (US:2016) For personal use only Total Pet Expenditure: $70b1 US Dog/Cat Populations (2016)1 Vet Care Expenditure $17b1 94m 90m Pet drug market $10.2b by 20182 (8% CAGR) $ Willingness to pay more for treatment3 ($2K-$5K/treatment) 1. http://www.americanpetprod
Slide 21: Pets and Cancer
Pets and Cancer For personal use only ● 1 in 4 dogs die of cancer ● Pets are living longer (50% dogs >10yrs die of cancer) ● 6 million dogs diagnosed with cancer in US/yr ● Significant unmet need for new oncology drugs ($500m-$1b market) ● Vet therapeutic market dominated by repurposed drugs already
Slide 22: Multiple options for MPL in dog Lymphoma market
Multiple options for MPL in dog Lymphoma market For personal use only 200K/Yr Lymphoma in US Maintenance/PFS General Vet Practitioner Market MPL Diagnosis ($2K) Maintenance/PFS MPL Remission/PFS (80%) Niche Vet Oncology MPL MaintenancePFS Relapse PFS: Progression Free Survival MPL PharmAust Investor
Slide 23: Animal Health Commercialisation Strategy
Animal Health Commercialisation Strategy: Target General Vet Practitioner Market For personal use only ● Monepantel: Meets requirements to target Vet General Practise market ● Monepantel can be delivered orally, is non-toxic (safe) and amenable to daily dosing ● Target vets in major markets: US (90K
Slide 24: Epichem
For personal use only Epichem PharmAust Investor Presentation (Aug 2017) 24
Slide 25: About Epichem
About Epichem For personal use only ● Specialist Synthetic & Medicinal Chemistry Services ● Highly awarded West. Aust. Company (Founded 2003) ● Staff of 23 (15 PhD's) Revenues Drug Discovery & Technical Proprietary Drug Fine Chemicals Catalogue Services Discovery Platform - Fee for Service Consultan
Slide 26: Epichem Revenues
Epichem Revenues For personal use only $6.2m Revenues Phase 2 Lab Expansion $5,000,000 $4.3m $4,000,000 Phase 1 Lab Expansion $3,000,000 $2,000,000 $1,000,000 $0 2008-09 2010-11 2012-13 2014-15 2015-16 2016-17 2018-19 2020-21 Revenues Record $3.05m revenues achieved in 2017 FY PharmAust Investor Pre
Slide 27: Key Drivers for Epichem Growth
Key Drivers for Epichem Growth For personal use only • Planned Phase 2 Lab Expansion increases capacity to meet demand • Pursuing ISO17025/34 accreditation – highest ‘calibration and testing’ stds. • Facilitates expansion of high margin catalogue business • Lower Australian Dollar maintains global c
Slide 28: Next Steps and Roadmap
For personal use only Next Steps and Roadmap PharmAust Investor Presentation (Aug 2017) 28
Slide 29: Key Drivers for 2017
Key Drivers for 2017 For personal use only Complete Phase II Lymphoma Trial in Dogs Q3/Q4 Complete MPL Reformulation Q4 Initiate Phase II Clinical Trial in Dogs using Q4 reformulated product Growth of Epichem Business Q2-Q4 Progress Novartis/ELANCO Option Q4 PharmAust Investor Presentation (Aug 2017
Slide 30: Reformulation to resolve MPL palatability
Reformulation to resolve MPL palability For personal use only 2017 Pills/Capsules Gelatin Reformulate GMP-grade Scaled production encapsulation manufacture for clinical trial MPL 25 mg/ml MPL 250 mg/tablet Taste Reformulation achieves 3 strategic outcomes: • Overcome foul taste of Zolvix which has r
Slide 31: PharmAust's Therapeutic Pipeline
PharmAust’s Therapeutic Pipeline For personal use only Compound Discovery Screening Preclinical Phase 1 Phase 2 Phase 3 PAA1 Solid Tumours PAA1 Non-Cancer PAA1 Solid Tumours (Dogs) PAA1 Lymphoma (Dogs) Novel PAA1 analogues PharmAust Investor Presentation (Aug 2017) 31
Slide 32: Pet market value comparators (2017)
Pet market value comparators (2017) For personal use only Nexvet: Acquired by Zoetis (Pfizer) for US$85m @66% premium to closing share price Oasmia Pharma: Spun out 2 Vet assets to wholly-owned subsidiary valued at US$75-80m Assets include Doxphos (reformulated doxorubicin) and Paccal Vet (reformula
Slide 33: Australian Peer Companies
Australian Peer Companies Company Description Market Cap ($Aus)1 For personal use only Antara Lifesciences Animal/Human Health Antimicrobial (Detach) $47m (ASX: ANR) Revenues 2017 FY $1m, EBITDA -3.4m National Vet Care Consolidated Vet Practices $127m (ASX: NVL) Apiam Animal Heath Consolidated Vet P
Slide 34: Global Peer Animal Health Companies
Global Peer Animal Health Companies Company Description Market Cap ($US)1 For personal use only Zoetis Worlds largest diversified animal health company $29b (NASDAQ) Masitinib for human (Ph3) and pet cancers (Registered). AB-Science Validates PAA model of developing one drug for $483m (Euronext) mul
Slide 35: PharmAust's Value Proposition
PharmAust’s Value Proposition For personal use only • $10m Market Cap = Enterprise Value (revenue + cash + phase II ready asset) • Developing a single product for multiple markets in human & animal health. • Validated model: Lower costs/development risks, accelerates path to multiple value accretion
Slide 36: Contact
For personal use only Epichem Pitney Pharmaceuticals Dr Richard Hopkins Dr Roger Aston CEO Executive Chairman ASX: PAA [email protected] [email protected] ACN 094 006 023 Phone: +61 (0) 405 656 868 Phone: +61 (0) 402 762 204 PharmAust Investor Presentation (Aug 2017) 36