Arovella Therapeutics Limited · ASX:ALA
Arovella Therapeutics — Investor Presentation (March 2021)
24 slides from Arovella Therapeutics's investor presentation, Mar 30, 2021
Slide 1: SUDA Investor Presentation
SUDA Investor Presentation 30th March 2021 © Copyright SUDA Pharmaceuticals Ltd 2021
Slide 2: Company Highlights Focus – Oncology and CNS
Company Highlights Focus – Oncology and CNS ▪ Refreshed Board and Management Team: Actively seeking new deal flow for technologies with a focus on oncology and the central nervous system ▪ Unique Platform Technology – OroMist™: Reformulate existing billion-dollar drugs for oral delivery, faster path
Slide 3: Company Overview
Company Overview Financial Snapshot ASX CODE SUD Market capitalisation* $16.5 million Shares on issue 386.66 million 52-week low / high $0.025 / $0.97 Cash (31st Dec 2020) $5.47 million Sector Biotechnology Major Shareholders Shareholder Ownership (%)* ZERRIN INVESTMENTS PTY LTD 15,000,000 (3.90%) K
Slide 4: Technology Highlights - OroMist
Technology Highlights - OroMist™ ▪ Clinical Data1 Demonstrates: ▪ Increased Bioavailability The most effective drug dosing methods ▪ The drug bypasses the gastro-intestinal tract preventing breakdown so patients can potentially take less drug Bioavailability (% absorbed) ▪ Faster onset of action: ▪
Slide 5: IP & Platform Strategy
IP & Platform Strategy INTELLECTUAL PROPERTY ▪ Multiple patent families covering: ▪ Many high-usage existing drugs formulated into oral sprays ▪ Hydrotrope technology for better delivery of drugs across the oral mucosa ▪ Anagrelide use in metastatic disease – granted in Europe, Japan and Australia P
Slide 6: Pharmaceutical Partnership Strategy
Pharmaceutical Partnership Strategy 6 © Copyright SUDA Pharmaceuticals Ltd 2021
Slide 7: Business Strategy - Develop and License
Business Strategy - Develop and License License Internal Sales Drug Regulatory Development Feasibility Preclinical Clinical trials Approved (royalties) Submissions ZolpiMist* (insomnia) Sumatriptan (migraine) Medical Grade Target Assets Cannabis Undisclosed Anagrelide (solid tumours) Value *ZolpiMis
Slide 8: Expanding our Portfolio
Expanding our Portfolio ▪ Over 18-24 months SUDA has refreshed the board and senior management group ▪ The team has expertise in sourcing, evaluating and acquiring novel technologies ▪ SUDA’s key areas of focus are oncology and the central nervous system ▪ SUDA will continue to source deal flow and
Slide 9: Board & Senior Management
Board & Senior Management Chairman CEO & Managing Director Executive Director Director Paul Hopper Dr. Michael Baker David Phillips David Simmonds Over 25 years experience in the Over 15 years experience in scientific Senior Business Development Executive David was a senior audit partner with medica
Slide 10: Our Focus For The Year Ahead
Our Focus For The Year Ahead ▪ ZolpiMist commercialization – assist current partners and secure additional partnerships ▪ Work with MedPharm to stabilise the anagrelide formulation and initiate preclinical studies ▪ Continue development work with our partners - Sanofi, Strides Pharma and Cann Pharma
Slide 11: Strategic Future
Strategic Future ▪ SUDA will continue to source, evaluate and acquire new technologies ▪ Continue to expand the team with deep Biotechnology/Drug Development/Pharma experience ▪ Build out the intellectual property portfolio – patents and knowhow ▪ Build out the OroMist platform to reformulate existi
Slide 12: Anagrelide - Reformulating to Treat Cancer
Anagrelide - Reformulating to Treat Cancer ▪ Anagrelide: An approved generic drug to treat a rare blood disorder ▪ Research Shows: Cancer patients with high platelet counts have a poor prognosis and lowering platelets may increase survival rates ▪ Making Anagrelide Safer: The capsule has unwanted si
Slide 13: Anagrelide Highlights
Anagrelide Highlights Anagrelide has been The range of solid Anagrelide has been in approved to treat tumours that present clinical use for >20 Essential with increased platelet years and has a Thrombocythemia in the levels suggest demonstrated safety US and the EU significant therapeutic profile po
Slide 14: Broad Technology Applicability
Broad Technology Applicability Lung Multiple Opportunities Cancer1 Breast 22% Ovarian ▪ Thrombocytosis is implicated in a number of different Cancer6 Cancer1 cancer types 18.2% 29% ▪ Increased platelet levels are prognostic for poor survival rates in numerous cancer types Vulva Renal Cancer5 Cell1 L
Slide 15: Increased Platelets = Reduced Cancer Patient Survival Rates
Increased Platelets = Reduced Cancer Patient Survival Rates Overall survival (months); high ▪ Thrombocytosis is implicated in Cancer multiple cancer types platelet vs low platelet* ▪ Cancer patient survival rates Lung1 38 vs 63 are decreased in the background of increased Ovarian2 31.2 vs 55.8 plate
Slide 16: Why Anagrelide is Unique
Why Anagrelide is Unique ▪ Anagrelide blocks cancer cell stimulation of platelet production which otherwise encourages cancer development ▪ Anagrelide acts directly by blocking cancer cell migration from the blood stream to lungs or bone marrow ▪ Anagrelide acts indirectly by reducing platelet numbe
Slide 17: Improving Anagrelide's Safety Profile
Improving Anagrelide’s Safety Profile 50 Background INCREASE IN BLOOD CONCENTRATION 40 ▪ Anagrelide was approved by the FDA in 1997 and the EMA in 2004 RELATIVE TO THE CAPSULE (%) ▪ From clinical data, serious cardiovascular events, including 30 congestive heart failure, were reported. ▪ In a recent
Slide 18: Intellectual Property Strategy
Intellectual Property Strategy SUDA holds the IP for use of anagrelide to treat cancer ▪ “Prevention and treatment of metastatic disease in thrombocytotic cancer patients” Priority date 22 December 2014. ▪ Europe Grant - June 2019 ▪ Japan Grant - May 2020 ▪ Australia Grant - Sept 2020 ▪ SUDA continu
Slide 19: Anagrelide Preclinical Development Strategy
Anagrelide Preclinical Development Strategy Formulation Development ▪ Convert anagrelide from solid dose form to an oral spray ▪ Target delivery volume is a maximum of 140 µl for the optimal residency time ▪ Optimize solubility and stability using an FDA acceptable dosing vehicle Ongoing with MedPha
Slide 20: ZolpiMist® - Insomnia
ZolpiMist® - Insomnia ▪ ZolpiMist is SUDA’s spray version of the insomnia drug Ambien ▪ Ambien was Sanofi’s blockbuster insomnia drug ▪ Short-term insomnia has an estimated prevalence of 9.5% in the US1 ▪ TGA approval for ZolpiMist was granted in July 2020 – SUDA is continuing to advance discussions
Slide 21: ZolpiMist – Sleep Response
ZolpiMist – Sleep Response ZolpiMist™ induced sleepiness significantly ZolpiMist™ 5mg induced sleepiness faster faster than Ambien® than Ambien® 10mg tablets Reduction in DSST Score from baseline at 13 min. Reduction in DSST Score from baseline at 13 min. 1 1 10mg 5mg 10 mg 5 mg 0 0 -2 -2 -4 -3.7 -3
Slide 22: Sumatriptan - Migraine
Sumatriptan - Migraine ▪ Sumatriptan is the generic name for Glaxo’s blockbuster migraine drug known as Imitrex. Similar class drugs were developed by Merck & J&J ▪ Migraine has a prevalence of ~13% in the US and ~15% in Europe making this a large opportunity for SUDA ▪ Attractive licensing deal for
Slide 23: Disclaimer
Disclaimer The purpose of the presentation is to provide an update of the business of SUDA PHARMACEUTICALS LTD (ASX:SUD) [‘SUDA’]. These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. Accordingly, these slid
Slide 24: Contact Dr Michael Baker CEO & Managing Director
The CFO Solution Level 3 62 Lygon Street Carlton VIC 3053 (T) +61 8 6142 5555 (F) +61 8 9443 8858 CONTACT Dr Michael Baker CEO & Managing Director Email: mbaker@sudapharma.com Mobile: +61 403 468 187 © Copyright SUDA Pharmaceuticals Ltd 2021
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