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
Broker Briefing: September 2021
Column 1 Column 2 0 {colgroup} 1 {col}{/col}{col}{/col} 2 {/colgroup} 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%
~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
Dogs on trial going camping and playing in the park
- 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
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
• Hypothesis: MPL induces autophagy to clear protein build up in nerve cells
- 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
FightMND
Berkshire Community College
- 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
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-1Other antivirals
- 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
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
Broker Briefing: September 2021 9
- 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
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 SecNeville Bassett, Non-Executive Director
- > 20 years experience in biotech & healthcare
- Extensive experience in relation to public company responsibilities, including ASX & ASIC compliance, corporate governance & statutory financial reporting
• 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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Last
22.0¢ |
Change
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Mkt cap ! $86.90M |
Open | High | Low | Value | Volume |
23.0¢ | 23.5¢ | 22.0¢ | $111.9K | 495.0K |
Buyers (Bids)
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4 | 128392 | 22.0¢ |
Sellers (Offers)
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23.0¢ | 48891 | 4 |
View Market Depth
No. | Vol. | Price($) |
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4 | 128392 | 0.220 |
4 | 62328 | 0.215 |
4 | 136395 | 0.210 |
6 | 63967 | 0.205 |
6 | 79900 | 0.200 |
Price($) | Vol. | No. |
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0.230 | 48891 | 4 |
0.235 | 159983 | 3 |
0.245 | 61000 | 4 |
0.250 | 364000 | 5 |
0.255 | 75500 | 2 |
Last trade - 16.10pm 02/05/2024 (20 minute delay) ? |
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Change
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