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In the opinion of the Directors:

1. the financial statements and notes of the consolidated entity are in accordance with the Corporations Act 2001, including:

a) giving a true and fair view of the consolidated entity’s financial position as at 30 June 2020 and of its performance for the year ended on that date; and

b) complying with Accounting Standards; and

c) complying with International Financial Reporting Standards as disclosed in Note 1

1. there are reasonable grounds to believe that the Company will be able to pay its debts as and when they become due and payable; and
2. the audited remuneration disclosures set out in pages 36 to 47 of the Directors Report comply with Section 300A of the Corporations Act 2001.

This declaration is made in accordance with a resolution of the Board of Directors. The Directors have been given the declarations by the Chief Executive Officer and Chief Financial Officer required by Section 295A of the Corporations Act 2001.

ALPHA-MELANOCYTE STIMULATING HORMONE 

(α-MSH)

A peptide hormone which activates or stimulates the production and release of (eu)melanin in the skin (melanogenesis).

EUROPEAN MEDICINES AGENCY (EMA)

The decentralised body of the European Union regulating medical drugs and devices.

EUMELANIN

A black or brown pigment mainly concerned with the protection of the skin by absorbing incoming UV radiation. This protective ability warrants melanin to be termed a photoprotectant (a substance capable of providing protection against radiation from the sun). α-MSH acts specifically to stimulate (eu)melanin synthesis.

FOOD AND DRUG ADMINISTRATION (FDA)

The USA’s regulatory agency for food, tobacco, medicines, and devices.

MELANIN

The dark pigment synthesised by melanocytes; responsible for skin pigmentation.

MELANOCORTINS

Melanocortins are a group of peptide hormones, consisting of adrenocorticotropin hormone (ACTH), α-melanocyte stimulating hormone (α-MSH), beta-melanocyte-stimulating hormone (β-MSH), and gamma-melanocyte-stimulating hormone (γ-MSH) and are derived from proopiomelanocortin (POMC) in the pituitary gland. 

MELANOCORTIN RECEPTORS

Melanocortins exert their effects by binding to and activating melanocortin receptors, a family of five (MC1R to MC5R) seven-transmembrane G-protein coupled receptors (GPCRs) that affect different body functions. The receptors are widespread throughout the body, exhibiting myriad ligand affinities, tissue and cell distribution, and downstream effects.

MELANOGENESIS

The process whereby melanin is produced in the body.

NARROWBAND ULTRAVIOLET B (NB-UVB) PHOTOTHERAPY

Therapy which utilises an ultraviolet B light source to activate melanin in vitiliginous lesions of the skin.

OECD

The Organisation for Economic Co-operation and Development. A group of 34 member countries that discuss and develop economic and social policy.

PHASE I

The first trials of a new drug candidate in humans, Phase I trials are designed to evaluate how a new drug candidate should be administered, to identify the highest tolerable dose and to evaluate the way the body absorbs, metabolises and eliminates the drug.

PHASE II

A Phase II trial is designed to continue to test the safety of the drug candidate, and begins to evaluate whether, and how well, the new drug candidate works (efficacy). Phase II trials often involve larger numbers of patients.

PHASE IIB/PHASE III

Advanced-stage clinical trials that should conclusively demonstrate how well a therapy based on a drug candidate works. Phase III trials can be longer and typically much larger than Phase II trials, and frequently involve multiple test sites. The goal is statistically determining whether a therapy clinically improves the health of patients undergoing treatment while remaining safe and well tolerated.

PHARMACODYNAMICS

The study of the time course of a drug’s actions in the body.

PHARMACOKINETICS

The part of pharmacology that studies the release and availability of a molecule and drug in the human body.

PHOTODERMATOSES

Photodermatoses are a variety of skin conditions that develop as a result of exposure to ultraviolet radiation or visible light.

PHOTOPROTECTION

Protection from light and ultraviolet radiation. Melanin provides natural photoprotection to skin, whilst sunscreens provide artificial photoprotection.

SUBCUTANEOUS 

Underneath the skin.

SUSTAINED RELEASE/CONTROLLED-RELEASE 

Process whereby a drug is released from a formulation over a period of time.

THERAPEUTIC GOODS ADMINISTRATION (TGA) 

Australia’s regulatory agency for medicinal products and devices.

ULTRAVIOLET (UV) RADIATION

Part of the electromagnetic spectrum at wavelengths below 400 nanometers, also called the invisible portion of light. There are three sub-types of UV: UVC <280 nm; UVB 280 – 320 nm; UVA 320 – 400 nm