Investor Presentation
2024-06-03 · Island Pharmaceuticals · original irmau.com ↗
Island Pharmaceuticals Limited ACN 641 183 842 | Registered office: Suite 201, 697 Burke Rd, Camberwell VIC 3124, Australia Page 1 of 2 3 June 2024 ASX Announcement Island presentation for Australian investor roadshow MELBOURNE Australia, 3 June 2024: Australian antiviral drug development company, Island Pharmaceuticals Ltd (ASX: ILA; “Island”; “the Company”) is pleased to release a copy of the presentation that will be delivered by Dr David Foster, CEO and Managing Director during investor meetings over the coming fortnight. Highlights from the presentation include: Pharmacokinetic modeling updates, following the recent completion of Island’s single ascending dose study Proposed updates to the approach for Island’s Phase 2 clinical study for ISLA-101 in dengue fever A copy of the presentation is appended to this announcement. To subscribe to Island’s monthly newsletter, IslandWatch, and other forms of email communications, please visit this page of our website. Approved for release to the ASX by: Dr Paul MacLeman Executive Chairman Island Pharmaceuticals Ltd [email protected] Investors and media, for further information, please contact: Jane Lowe IR Department Mobile: +61 411 117 774 [email protected] About Island Pharmaceuticals Island (ASX: ILA) is a drug repurposing company, focused on areas of unmet need for antiviral therapeutics to address infectious diseases. Our lead asset is ISLA-101, a drug with a well- established safety profile, being repurposed for the prevention and treatment of dengue 2 fever and other mosquito (or vector) borne diseases. Island Pharmaceuticals Limited ACN 641 183 842 | Registered office: Suite 201, 697 Burke Rd, Camberwell VIC 3124, Australia Page 2 of 2 If ISLA-101 achieves FDA approval, and certain other criteria are met, Island may be eligible to obtain a "Priority Review Voucher" at the time of FDA approval. This means that as well as getting approval to manufacture and sell ISLA-101, the Priority Review Voucher (PRV) could permit Island to expedite the FDA approval process for a new drug or sell the PRV in a secondary market. Island encourages all current investors to go paperless by registering their details with the Company's share registry, Automic Registry Services, whose contact info is housed on the Shareholder Services page of the Company’s website. Visit www.islandpharmaceuticals.com for more on Island. ISLAND PHARMACEUTICALS JUNE 20241 COMBATTING URGENT VIRAL DISEASE THREATS WITH A KEY FOCUS ON DENGUE FEVER (ASX: ILA)JUNE 2024 ISLAND PHARMACEUTICALS JUNE 20242 DISCLAIMER This presentation has been prepared by Island Pharmaceuticals Limited (ABN 641 183 842) (Company or Island Pharmaceuticals). Not an offer or financial product advice The Company is not licensed to provide financial product advice. This presentation is not and should not be considered, and does not contain or purport to contain, an offer or an invitation to sell, or a solicitation of an offer to buy, directly or indirectly any securities, to any person in any jurisdiction to whom or in which such offer or solicitation is unlawful nor shall it (or any part of it), or the fact of its distribution, form the basis of, or be relied on in connection with or act as any inducement or recommendation to enter into, any contract whatsoever relating to any securities. This presentation is for information purposes only and is not a prospectus, product disclosure statement, pathfinder document for the purposes of section 734(9) of the Australian Corporations Act 2001 (Cth) (Corporations Act) or other offer document under Australian law or the law of any other jurisdiction. This presentation does not constitute an invitation to apply for or purchase Securities and does not include any application form for Securities. This presentation does not constitute an advertisement for an offer or proposed offer of Securities. Neither this presentation nor anything contained in it shall form the basis of any contract or commitment and it is not intended to induce or solicit any person to engage in, or refrain from engaging in, any transaction. Nothing in this presentation constitutes legal, financial, tax or other advice. Recipients of the presentation should conduct their own investigation, evaluation and analysis of the business and other data and information set out in the presentation. Financial data All dollar values are in Australian dollars ($ or A$) unless otherwise stated. Any financial data in this presentation is unaudited. Past performance The operating and historical financial information given in this presentation is given for illustrative purposes only and should not be relied upon as (and is not) an indication of the Company's views on its future performance or condition. Actual results could differ materially from those referred to in this presentation. You should note that past performance of the Group is not and cannot be relied upon as an indicator of (and provides no guidance as to) future Group performance. Future performance This presentation contains certain "forward-looking statements". The words "expect", "anticipate", "estimate", "intend", "believe", "guidance", "propose", "goals", "targets", "aims", "outlook", "forecasts", "should", "could", "would", "may", "will", "predict", "plan" and other similar expressions are intended to identify forward-looking statements. Any indications of, and guidance on, future operating performance, earnings and financial position and performance are also forward-looking statements. Forward-looking statements in this presentation include statements regarding the Company's future growth options, strategies and new products. Forward-looking statements, opinions and estimates provided in this presentation are based on assumptions and contingencies which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations of current market conditions. Forward-looking statements, including projections, guidance on future operations, earnings and estimates (if any), are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. No representation is given that the assumptions upon which forward looking statements may be based are reasonable. This presentation contains statements that are subject to risk factors associated with the Group's industry. These forward-looking statements may be affected by a range of variables which could cause actual results or trends to differ materially, including but not limited to earnings, capital expenditure, cash flow and capital structure risks and general business risks. No representation, warranty or assurance (express or implied) is given or made in relation to any forward- looking statement by any person (including the Company). In particular, but without limitation, no representation, warranty or assurance (express or implied) is given that the occurrence of the events expressed or implied in any forward looking statements in this presentation will actually occur. Actual operations, results, performance or achievement may vary materially from any projections and forward- looking statements and the assumptions on which those statements are based. Any forward looking statements in this presentation speak only as of the date of this presentation. Subject to any continuing obligations under applicable law, the Company disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this presentation to reflect any change in expectations in relation to any forward-looking statements or any change in events, conditions or circumstances on which any such statement is based. Nothing in this presentation will under any circumstances create an implication that there has been no change in the affairs of the Group since the date of this presentation. ISLAND PHARMACEUTICALS JUNE 20243 Island Pharmaceuticals (ASX: ILA) is an antiviral therapeutics company targeting infectious diseases ISLAND PHARMACEUTICALS JUNE 20244 INVESTMENT HIGHLIGHTS Lead product ISLA-101 targeting dengue fever (lead indication) with further potential across a range of other mosquito-borne viruses: Zika, yellow fever and Chikungunya. Dengue fever infects up to 400m per year.* Endemic in >100 countries. Major market with no current pharmaceutical treatment. Potential preventative and therapeutic for travellers, military and governments. All endpoints achieved with recent Single Ascending Dose study. Data now being submitted to US FDA – Island is seeking to expand study to include both prophylactic and therapeutic arms (prev. focused on prophylactic alone.) Addressing a high unmet need Significant market opportunity Expanding clinical use cases Tropical diseases like dengue qualify under FDA’s Priority Review Voucher scheme. Open to ISLA-101 at the time of FDA approval. Last ten PRVs sold for an average of US~$110M – significant potential and relevance to Island. Eligible for high value PRV Targeting other viruses with significant unmet need and limited competition.Pipeline expansion underway * WHO data – as at 30 May 2024: https://www.who.int/news-room/fact-sheets/detail/dengue-and-severe-dengue ISLAND PHARMACEUTICALS JUNE 20245 “About half of the world's population is now at risk of dengue with an estimated 100–400 million infections occurring each year” World Health Organisation, 30 May 2024 ISLAND PHARMACEUTICALS JUNE 20246 DENGUE IS CLOSE TO HOME Source 1 Source 4 Source 3 Source 2 Article sources: 1. https://www.news.com.au/travel/travel-updates/travel-stories/deadly-viral-infection-doubles-in-popular-tourists-spots- for-aussies/news-story/fc32fa4fc37ee1ed4ca48a4deb44f51c 2. https://shorturl.at/NsvwY 3. https://www.nbcnews.com/health/health-news/dengue-fever-climate-change-mosquitos-tropical-disease-rcna149366 4. https://www.euronews.com/health/2024/04/24/france-warns-of-surge-in-imported-dengue-cases-ahead-of-olympics ISLAND PHARMACEUTICALS JUNE 20247 DENGUE IS A WIDESPREAD ISSUE https://www.healthmap.org/dengue/en - visited May 30, 2024 Dengue outbreaks occurred in many countries of the world in the Americas, Africa, the Middle East, Asia, and the Pacific Islands HealthMap: recent reports of local or imported dengue cases ISLAND PHARMACEUTICALS JUNE 20248 DENGUE IN 2050 – A GLOBAL DISEASE Prediction based on projections of future temperatures, rainfall, and mosquito populations NASA Earth Observatory map by Lauren Dauphin based on data from Janey Messina, University of Oxford - https://earthobservatory.nasa.gov/features/disease-vector USA Europe Australia ISLAND PHARMACEUTICALS JUNE 20249 INFECTION AND SPREAD Uninfected mosquito Mosquito bites infected person Mosquito is infected (10-14 days incubation)Mosquito bites / infects a healthy person 1-14 day incubation time Why the surge in dengue infections? Warmer temperatures • Accelerate development • Increase activity of female mosquitoes • Reduce incubation time for mosquito to become infectious • Allow mosquitoes to survive longer through winter High humidity • Improves mosquitoes’ chance of survival Extreme weather • Disrupts water / sanitation • Increased flooding can enhance breeding How dengue fever spreads ISLAND PHARMACEUTICALS JUNE 202410 DENGUE CAN BE LETHAL IF NOT MANAGED ON TIME • Headache • Pain behind the eyes • Nausea • Vomiting • Diarrhea • There is no specific treatment for dengue or dengue haemorrhagic fever • Symptomatic relief (paracetamol etc) only. • High fever • Rashes • Muscle pain • Flu-like symptoms • Joint and muscle pain • Antibody detection • Antigen detection • RNA detection • Viral isolation • Vaccines with limited availability • Mosquito nets • Insect sprays • Wearing protective clothing (hard in hot climates) • Fumigation • Covering containers and showing vigilance around water Moderate symptoms: • Shock • Severe pain in the stomach • Blood pressure drops • Severe bleeding • Severe vomiting Severe symptoms: • Difficulties affecting the heart, lungs or liver • Bruising and pooling of blood under the skin • Seizure It directly impacts both white blood cell count and platelets, which are vital for body protective mechanisms US$8.9B Estimated impact to the economy from dengue fever Diagnosis: Treatment: Prevention: ISLAND PHARMACEUTICALS JUNE 202411 Travelers Military National Outbreaks Malaria is also a mosquito borne disease and therefore a proxy for dengue. Market for anti-malarials is expected to reach US$1B1 by 2026 Relationship with US Army in place for Phase 2 study (CRADA.) Will continue discussions as program advances Millions of patients in Latin America offer potential for sales in disease suppression and treatment during outbreaks COMMERCIAL OPPORTUNITY 1. https://www.alliedmarketresearch.com/anti-malarial-drug-market Government Stockpiles Priority Review Voucher Potential for endemic countries to establish and maintain drug stockpiles as happens with influenza Last ten PRVs sold for an average of US~$110M, with potential for ISLA-101 at the time of FDA approval ISLA-101 has potential as both a prophylactic and therapeutic ISLAND PHARMACEUTICALS JUNE 202412 About ISLA-101 ISLAND PHARMACEUTICALS JUNE 202413 ISLA-101 BROAD ACTIVITY EVIDENT • In in-vitro models ISLA-101 has demonstrated broad anti-viral activity • In in-vitro models using fresh human cells, ISLA-101 has demonstrated potent anti dengue-1 activity • In animal models, ISLA-101 is protective in dengue fever and Zika • In extremely lethal animal models, ISLA-101 was shown to prevent death in 70% of subjects • Increasing concentrations of ISLA-101 prevent death induced by an otherwise lethal dengue fever infection • 45 HUMAN Clinical Studies of ISLA-101 completed in other indications • Island’s own Single Ascending Dose study and further modelling reinforced safety / tolerability and identified Phase 2 dosing Dengue 1-4 Zika West Nile Yellow Fever Demonstrated activity against flaviviruses (a subgroup of arboviruses) in multiple models of infection ISLAND PHARMACEUTICALS JUNE 202414 ISLA-101 PREVENTS VIRAL REPLICATION ISLA-101 inhibits propagation of flaviviruses • To replicate, the virus needs to hijack the nucleus of the host cell • Studies demonstrated ISLA-101 prevents this, therefore preventing virus replication • Same mechanism of action for a therapeutic or prophylactic – either before or after exposure to the virus Mechanism of action (how it works) ISLA-101 reduces viral load1 Above: dose response showing ISLA-101’s ability to protect against dengue infection • In freshly isolated human cells, ISLA-101 was shown to potently reduce viral infection with a sub micromolar EC50 • Island’s SAD study was designed to also investigate the ability to achieve appropriate blood concentrations in healthy human volunteers (slide 16)1. Fraser et al. J. Infect. Dis 2014 ISLAND PHARMACEUTICALS JUNE 202415 ISLA-101 PREVENTS ANIMAL DEATHS FROM LETHAL DENGUE Survival curve showing protection from lethal dengue challenge by increasing dose of ISLA101 (mouse model). Fraser et al. J. Infect. Dis 2014 ISLA-101 has also been shown to be protective in animal models of both dengue and Zika Virus. Two doses of ISLA-101 prevent 70% of deaths by otherwise lethal dengue ISLAND PHARMACEUTICALS JUNE 202416 SINGLE ASCENDING DOSE STUDY DATA ACHIEVES ENDPOINTS, CONFIRMS PHASE 2 PLAN • Island completed a 24-subject Single Ascending Dose study for ISLA-101 in early 2024, with highly positive outcomes: ISLA-101 was safe and well tolerated Data analysis showed required levels of ISLA-101 concentration in the blood were observed after only a single dose, achieving the study's purpose Reinforcing the drug's safety and tolerability, in this study, Island dosed at levels equivalent to up to 10x the dose given in successful preclinical animal models (adjusted for differences in species) Also helped to build our experience with the drug, manufactured at today's standards and in a modern clinical setting • Post study in silico modelling confirmed the appropriate single, multi-day dose of 600 mg/m2/day (300 mg/m2 twice daily) for the coming Phase 2 study, enabling Island to be more targeted with dosing, and in turn reducing timeline / cost structure • Predicted blood concentration of ISLA-101 was 1.5 µM, well above calculated EC50 demonstrated to be effective in human cells (0.81 µM) Data modelling predicts 300 mg/m2 twice daily dose for Phase 2 study ISLAND PHARMACEUTICALS JUNE 202417 ISLA-101 DEVELOPMENT MILESTONES • With data from the Single Ascending Dose study in hand, Island now plans to interact with the US FDA regarding the study outcomes and strategies for how to maximise the data obtained from the Phase 2 study • Plan is to incorporate a proposed therapeutic arm into the Phase 2 study, as well as the originally planned prophylactic arm • Based on in silico modelling data, protocol expected to be single-level, multi-day dose (rather than multiple ascending dose per original plans) • Plan is to incorporate a proposed therapeutic arm into the Phase 2 study, as well as a modified prophylactic arm • Revised protocol being submitted to FDA • Island has agreements and study partners in place for the study, so would expect it to commence quickly following submission of revised protocol • Trial costs being finalised – further information to be released shortly ISLAND PHARMACEUTICALS JUNE 202418 WHY TARGET DENGUE FIRST? Significant unmet need for disease with increasing incidence ISLAND PHARMACEUTICALS JUNE 202419 LIMITED SOLUTIONS Dengue fever West Nile Zika Virus Yellow Fever Japanese encephalitis Comments Worldwide prevalence 400 million n/a Up to 1.5 million 130,000 70,000 Viral diseases are a leading cause of hospitalization and death Effective drug therapy available? No No No No No Other drugs have been explored in clinical trials but none approved. J&J is in Phase 2 with a dengue-specific anti-viral; Atea recently canceled their program following unsuccessful trials. Vaccine available? Limited No No Limited Limited Vaccine development has been wrought by years of failures. Challenge is that the vaccine needs to protect against all 4 strains of dengue to an equivalent level. Sanofi has an approved vaccine that was approved following controversial clinical trials. It currently has a very limited label. Takeda is developing a vaccine that is being approved but does not equally protect against all 4 strains of dengue. Deformities in babies from mothers with Zika ISLAND PHARMACEUTICALS JUNE 202420 BUILDING OUR PIPELINE • In addition to ISLA-101, Island is exploring the acquisition or in-licensing of new drug candidates • Specific screening and scoring criteria being applied, based in part on the following criteria: • small molecule program • anti-viral • eligible for a Priority Review Voucher • national and military preparedness focus • possible non-dilutive funding to support clinical studies. ISLAND PHARMACEUTICALS JUNE 202421 CORPORATE SNAPSHOT Share price (AUD1) $0.075 Market cap1 $8.59m Shares on issue1 114,536,544 Options with piggy-back right2 31,746,700 Cash3 $1.6m 1. As at 29 May 2024 | 2. ILAO Option terms: Exercise price $0.06 expire 14 March 2025. Piggy Back Right: If the Options are exercised on or before 14 June 2024, optionholders will be issued one Further Option (Piggy Back Option) for every Option exercised on the same terms | 3. As at 31 March 2024 – does not take into consideration cash burn since March or injections from option conversions | 4. Shares held per ASX lodged substantial holder notices | Share price data sourced from asx.com.au Key data Recent ILA trading history Board of Directors Ownership breakdown Dr Paul MacLeman, Executive Chairman Dr David Foster, CEO and Managing Director Dr David Brookes, Non-Executive Director Mr Albert Hansen, Non-Executive Director Dr Anna Lavelle, Non-Executive Director • Top 201: 73.77% • Board and management1: 15.11% Shareholder Ownership4 Dr William James Garner 22,056,105 (19.26%) Mr Jason Alan Carroll 20,000,000 (17.46%) Albert Hansen / Kesa Partners 11,104,034 (9.69%) Substantial shareholders ISLAND PHARMACEUTICALS JUNE 202422 SCIENTIFIC ADVISORY BOARD Dr Leigh Farrell Leigh has over 30 years’ experience in the biotechnology and pharmaceutical industry and is Head of Health Security Systems Australia, a Division of DMTC Ltd, is a non-executive director of Pro Medicus Ltd, Ena Respiratory Pty Ltd and Axelia Oncology ty Ltd, and is a member of the Walter and Eliza Hall Institute of Medical Research Board Commercialisation Committee and a member of the Independent Advisory Council of Medicines Australia. Leigh’s past appointments include: Senior Vice President, Commercial at Certara USA, Inc where he was responsible for Asia Pacific Commercial and global government engagement for the preparedness, planning and response to major health emergencies; Chairman & COO of d3 Medicine, LLC; Vice President of Business Development at Biota Pharmaceuticals Ltd, Research Manager Johnson & Johnson Research and CEO of Gene Shears Pty Ltd. Leigh holds a PhD in Biochemistry and a Bachelor of Science (Honours) from Monash University and is a Fellow of the Australian Institute of Company Directors. Prof Stephen Thomas MD Professor Stephen Thomas, MD has an international leadership role as Lead Principal Investigator for Pfizer/BioNTech global Phase III COVID-19 vaccine trial now being deployed globally. Prof. Thomas is a world-renowned virologist and vaccinologist and has authored numerous papers and articles on dengue fever, Zika and many other infectious diseases. Chief, Division Of Infectious Diseases, New York Upstate Medical University; Professor of Medicine, Professor of Microbiology & Immunology, and Infectious Diseases physician-scientist from the State University of New York (SUNY), Upstate Medical University; Chief, Division of Infectious Diseases and Director, Institute for Global Health and Translational Science (IGHTS.) He had twenty years in the U.S. Army Medical Corps serving at the Walter Reed Army Institute of Research (WRAIR.) Dr Amy Patick Amy Patick is a scientific consultant with deep expertise in antiviral drug discovery, development and viral resistance with broad know how in emerging virus epidemics and translational medicine. Previously, Dr. Patick has served as Vice President, Research at Adamas Pharmaceuticals, Vice President, Biological Sciences at Genelabs Technologies, Head of the Antiviral Biology Therapeutic Area at Pfizer, Inc. and Research Scientist at Bristol-Myers Squibb Company. Dr. Patick has also served as President for the International Society of Antiviral Research. Dr. Patick was a postdoctoral fellow in immunology at the Mayo Clinic/Foundation in Rochester, MN and received her PhD in Medical Microbiology from the University of Wisconsin, Madison. ISLAND PHARMACEUTICALS JUNE 202423 UPCOMING MILESTONES** • Key US and Australian patents granted for ISLA-101 • Obtain HREC (i.e. IRB) approval • Screen, enrol and dose volunteers in SAD study • Successful progression through cohorts H1 FY 2024 (Jul – Dec 2023; Completed) H2 FY 2024 (Jan – Jun 2024) • Dose final Single Ascending Dose study subject • Single Ascending Dose study read out • FDA interaction on Phase 2 study protocol • Pipeline expansion efforts • Complete in silico modelling of multiple dosing regimen H1 FY 2025 (Jul – Dec 2024) • Initiate Phase 2 trial • First patient dosed in Phase 2 trial • Advances through Phase 2 study cohorts • Continue pipeline expansion efforts • Ongoing discussions with potential partners H2 FY 2025 (Jan – Jun 2025) • Data readout from Phase 2 study • End of Phase 2 meeting anticipated with FDA • Plans announced for next steps in clinical program • Ongoing discussions with potential partners ISLAND PHARMACEUTICALS JUNE 202424 RECAP: FILLING A FAST-GROWING UNMET NEED Lead product ISLA-101 targeting dengue fever (lead indication) with further potential across a range of other mosquito-borne viruses: Zika, yellow fever and Chikungunya. Dengue fever infects up to 400m per year.* Endemic in >100 countries. Major market with no current pharmaceutical treatment. Potential preventative and therapeutic for travellers, military and governments. All endpoints achieved with recent Single Ascending Dose study. Data now being submitted to US FDA – Island is seeking to expand study to include both prophylactic and therapeutic arms (prev. focused on prophylactic alone.) Addressing a high unmet need Significant market opportunity Expanding clinical use cases Tropical diseases like dengue qualify under FDA’s Priority Review Voucher scheme. Open to ISLA-101 at the time of FDA approval. Last ten PRVs sold for an average of US~$110M – significant potential and relevance to Island. Eligible for high value PRV Targeting other viruses with significant unmet need and limited competition.Pipeline expansion underway * WHO data – as at 30 May 2024: https://www.who.int/news-room/fact-sheets/detail/dengue-and-severe-dengue ISLAND PHARMACEUTICALS JUNE 202425 Island Pharmaceuticals (ASX: ILA) islandpharmaceuticals.com @IslandPharma Island Pharmaceuticals
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