PAA 4.35% 22.0¢ pharmaust limited

READ AND THOROUFGHLY DIGEST

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    PharmAust is a clinical-stage company developing novel targeted cancer, neurodegenerative and antiviral therapeutics for humans and cancer therapeutics for animals. The company specializes in repurposing marketed drugs lowering the risks and costs of development
    ASX: PAA
    ACN 094 006 023
    Broker Briefing: September 2021
    PharmAust
    Company Snapshot
    Summary Share Price Movement
    Column 1 Column 2
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    1 {col}{/col}{col}{/col}
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    3 ASX Code: PAA
    4 Market Cap at $0.091 $28.87M
    5 Cash (June 2021) 3.02M
    6 Debt $0k
    7 Total Shares on Issue 317M
    8 Options (Unlisted) 5.3M
    9 Top 20 Own 37%
    10 Board/Exec Own 9.3%
    Broker Briefing: September 2021
    ~Repurposing
    1. MPL: AChR - mTOR
    2. Viagra: cardiovascular - men’s health 3. Tamoxifen: contraceptive - anti-cancer 4. Exanatide: diabetes – weight loss
    Anti-Wormicide: AChR
    Rufener et al., 2013
    Easter Island: mTOR
    Anti-Cancer: dog and human
    Monepantel (MPL) and mTOR
    MPL from Sheep Drench to Anticancer, Anti-neurodegenerative and Antiviral Agent
    Anti-Covid19; Anti-HTLV1
    PharmAust
    Anti-MND
    Berkshire Community College
    Aurbina
    Eckert and Higgins
    Broker Briefing: September 2021
    PharmAust Patent Portfolio
    Patents and Expiry
    1. USE OF AMINOACETONITRILES (MPL) IN CANCER
    ~2032
    2. TREATMENT OF DISEASES WITH AMINOACETONITRILES OPERATING THROUGH mTOR PATHWAY
    ~2032
    3. MPL IN COMBINATION WITH OTHER CANCER DRUGS
    ~2034
    4. MPL ANALOGUES IN CANCER ~2034
    5. MPL IN VIRAL DISEASE COVID-19 and HTLV1 ~2040
    MPL composition of matter patent owned by major company expires in 2024 in most jurisdictions.
    Broker Briefing: September 2021 4
    Dosage Form
    From Sheep Drench to At-Home Tablet
    Exceptional Safety Profile Convenient at-home tablet
    Broker Briefing: September 2021
    PharmAust: Canine Anticancer
    Pet Dog Phase 2 Trial
    • Prednisolone alone = 4 to 6 weeks OST
    • Post trial MPL + prednisolone, 4 of 6 dogs OST > 14 weeks
    • High QOL indices
    • CHOP alternative = 26 weeks @ $10 000 and many side effects
    Dogs on trial going camping and playing in the park
    Broker Briefing: September 2021 6
    PharmAust: Motor Neurone Disease/ Fight MND
    Motor Neurone Disease
    MND/ALS
    o Amyotrophic lateral sclerosis (ALS); Lou Gehrig’s Disease
    • Brain and spinal nerve stop working.
    • Associated with “proteinopathy” or toxic protein build up in nerve cells.
    • Life Expectancy 1-5 years
    • About 1 in 400 people
    • There are no cures
      Preclinical Data
    • Hypothesis: MPL induces autophagy to clear protein build up in nerve cells
    FightMND
    • AUD 881 085 funding for a Phase I/II clinical trial
      o Associate Professor Susan Mathers, Calvary Health Care
      Bethlehem, Melbourne
      o Professor Dominic Rowe, Macquarie University
    • Commencing early next year
    Berkshire Community College
    David Goodsell, Cell, 2016
    Brain
    Nerve
    Muscle
    FightMND
    Broker Briefing: September 2021 7
    PharmAust: Antiviral
    COVID-19/ HTLV-1
    Preclinical Data: SARS-CoV2
    • Three laboratories: MPL and MPLS both protect against SARS-CoV2 induced cell death
    • Two of two laboratories: MPL and MPLS reduce viral RNA in culture media
    • Two of two laboratories (similar conditions): MPL and MPLS reduce viral secondary
      infection
    • Very different conditions in third laboratory give no effect on secondary infection –
      good data for determining method of action
    • Combined: secondary infection data suggest late-stage viral lifecycle inhibitor
    • Consistent with hypothesis for autophagy-mediated mechanism
    • Hypothesis: MPL competes to prevent hijacking of host autophagy machinery and
      permits virus destruction
      HTLV-1
    • Retrovirus – like HIV
    • But makes blood cells divide like cancer
    • 20 million people worldwide; certain Australian indigenous populations
    • Very good preclinical models
    • Hypothesis: MPL competes to prevent hijacking of host autophagy machinery
      and permits virus destruction while also exerting anticancer effects
    Other antivirals
    MPL, MPLS
    NIAID
    Arsensio, Nature, 2020
    David Goodsell, Cell, 2016
    Broker Briefing: September 2021 8
    PharmAust: Human Anticancer
    Human Phase I, Moving to Phase II
    Clinical Data: Phase I
    • Treatment refractory progressing cancer patients
    • Three of four Level 1 patients had stable disease by CT scans
    • Three of four Level 1 patients had reduced mTOR (increased
      autophagy) markers
    • 92% of adverse events were mild
    • No myelosuppression (immune system still intact unlike chemo)
    • Very good blood plasma drug data
      Phase II: Set up
      • Anticancer activity plasma levels from tablets in pet dogs
      • Plasma levels from FightMND and Covid trials for tablet dosing
      • Preclinical data shows very effective combination
      • Physicians excited by combination: pancreatic, gastric and esophageal
    Broker Briefing: September 2021 9
    PharmAust: Clinical Programs
    Activity
    Indication
    Source
    Trial Phase
    Tablet No
    Treatment
    General Market size
    Sept 2021- March 2022
    Ongoing Pet Dog Cancer Trials
    Lymphoma
    Existing Mpl; Existing Catalent tablets
    Phase II/III
    ~ 12 000 CHOP, pred and Mpl
    US$ 500M – 1000M
    March 2022
    Phase 3 Pet Dog Cancer Trials
    Lymphoma
    Existing Mpl; New Syngene tablets
    Phase III
    ~ 25 000
    e.g. CHOP, pred and Mpl US$ 500M – 1000M
    April 2022
    FightMND and COVID19 Human Trials
    ALS/MND, SARS-CoV2 infections
    New Mpl;
    New Catalent tablets
    Phase I/II
    ~ 11 000
    MND: Riluzole COVID: e.g. Remdesivir
    MND: US$ 1B COVID: US$ 7.7B
    October 2022
    Human Cancer Trials
    Pancreatic, Gastric, Esophageal
    New Mpl;
    New Syngene tablets
    Phase I/II
    ~ 25 000
    e.g. Gemcitabine e.g. Platinum drugs
    US$ 125B
    Target Activity Timelines
    Broker Briefing: September 2021 10
    EXPERIENCED BOARD AND EXECUTIVE
    Dr Roger Aston, Executive Chairman & CEO
    • > 35 years experience in the pharmaceutical & healthcare industries
    • Director or chairman on a number of boards carrying out late-stage drug development
    • Former CEO of Mayne Pharma Ltd
      Robert Bishop, Executive Director
    • > 35 years experience in corporate finance & equity capital markets
    • Lawyer & investment banker
      Sam Wright, Finance Director & Co Sec
    • > 20 years experience in biotech & healthcare
    • Extensive experience in relation to public company responsibilities, including ASX & ASIC compliance, corporate governance & statutory financial reporting
    Neville Bassett, Non-Executive Director
    • Member of the Order of Australia (AM)
    • > 35 years working in accounting, finance & stockbroking• Chairman of Westar Capital Ltd
    Dr Richard Mollard, Chief Scientific Officer (CEO Pitney Pharmaceuticals)
    • > 25 years national and international pharmaceutical and biotech
    • CEOofsubsidiaryPitneyPharmaceuticalsPtyLimited
    • Honorary Fellow, Faculty of Veterinary and Agricultural Science, University of Melbourne
 
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