Cresaryn

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About Cresaryn

A privately held Australian company advancing a patented drug-delivery platform toward commercialisation.

Building on eight years of development

Pilot Human Pharmacokinetic Study

Cresaryn was established to apply the NanoCelle delivery platform to a clear unmet need in erectile-dysfunction treatment. The company licensed exclusive rights within the erectile-dysfunction field and selected tadalafil as its lead molecule because of its established PDE5 mechanism and long-duration profile.

The programme builds on approximately eight years of wider NanoCelle research and development, supported by substantial historical investment in formulation science, manufacturing and platform development. Cresaryn has since focused on product-specific formulation selection, analytical methods, stability, manufacturing preparation, local-tolerance work and the design of a pilot human pharmacokinetic study.

Professional experience relevant to pharmaceutical development

The company is led and governed by founder-shareholders and investors with professional experience relevant to pharmaceutical development, manufacturing, commercialisation and transactions. Its objective is to generate the evidence required to validate the product profile and position the company for ownership by a strategic pharmaceutical partner capable of accelerating global development and launch.

Key milestones include securing the exclusive field licence, selecting the lead tadalafil formulation, defining a proposed 505(b)(2) development strategy, contracting bioanalytical and local-tolerance activities and funding the program through its major near-term development milestones. Future milestones include preliminary minipig local-safety data, pilot human pharmacokinetic results, FDA alignment and IND opening. Dates and results remain subject to development and regulatory outcomes.

Cresaryn is a privately held Australian company governed by a board whose directors are founder-shareholders and investors.

Guided by a dedicated board

of pharmaceutical specialists

Mark Hickey

Founder and Chairman

Mark Hickey is a founder and director of Cresaryn and an experienced corporate lawyer with more than 30 years of professional experience. His background spans corporate governance, commercial transactions, property and investment. Mark is a director of Merano Partners and a graduate member of the Australian Institute of Company Directors. His broader leadership experience includes board and industry roles, and he was awarded the Bravery Medal in 2016.

Ross Sharpe

Founder and Director

Associate Professor Ross Sharpe is a founder and director of Cresaryn and an experienced physician, interventional cardiologist and endovascular specialist. He has more than 20 years of clinical practice and extensive experience in coronary, structural and congenital heart interventions. Ross is an Adjunct Associate Professor at Bond University and founder of Outreach Hearts, Heart Brain Private Clinic and the PFO Research Foundation Australia. He brings clinical, research and medical-device insight to the Cresaryn board.

Michael Hall

Founder and Director

Michael Hall is a founder and director of Cresaryn with more than 35 years of experience building and managing Australian nutrition and healthcare businesses. His career began in accounting, retail and private banking before progressing into senior operating and investment roles. Michael founded and helped build BioCeuticals and later served as Managing Director of FIT-BioCeuticals before its sale. He subsequently served as Chairman of Medlab Clinical. Michael holds a Bachelor of Commerce from UNSW and is a retired Certified Practising Accountant.

Alan Dworkin

Chief Financial Officer

Alan Dworkin is Chief Financial Officer of Cresaryn and a Chartered Accountant and Chartered Secretary with more than 20 years of finance and operational-management experience. Alan was CFO and Company Secretary of FIT-BioCeuticals and contributed to its sale to Blackmores. He subsequently served in senior financial, operational and company-secretarial roles at Medlab Clinical, supporting its ASX listing and growth. His experience spans pharmaceutical research, nutraceuticals, retail, resources, governance and listed-company financial management.

Prof. Luis Vitetta

Scientific Adviser

Professor Luis Vitetta is an experienced medical researcher with expertise in clinical trials, research policy, nutrition, probiotics, the human microbiome, epidemiology and integrative medicine. He is Professor at the University of Sydney Faculty of Medicine and Health and serves as Chief Medical Officer and consultant to the Medlab Group. Luis previously directed the Centre for Integrative Clinical and Molecular Medicine at the University of Queensland. He holds a BSc (Honours), PhD and postgraduate qualifications in integrative and nutritional environmental medicine.

A differentiated Erectile Dysfunction company approaching its transaction inflection