BOTANIX PHARMACEUTICALS LTD — Regulatory Filings 2018

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ASX/Media Release

7 November 2018

Botanix treats first patient in BTX 1308 psoriasis patient study

Key highlights

• Botanix has treated the first patient in its BTX 1308 psoriasis Phase 1b patient study

• Study is being conducted in partnership with international psoriasis model experts - Bioskin GmbH , using their unique clinically validated system

• Study represents the 3[rd] clinical program to commence within 12 months for Botanix, demonstrating the Company's ability to accelerate the addition of clinical programs across a range of skin diseases

Philadelphia PA and Sydney Australia, 7 November 2018: Medical dermatology company Botanix Pharmaceuticals Limited (ASX:BOT, “Botanix” or “The Company”) is pleased to announce the treatment of the first patient in its Phase 1b BTX 1308 psoriasis patient study. The study is testing a new formulation of synthetic cannabidiol combined with the Company’s novel Permetrex skin delivery technology.

The Phase 1b patient study is being conducted in collaboration with BioSkin GmbH (“Bioskin”), a German clinical contract research organisation (based in Hamburg), and an Australian dermatology clinic. Bioskin is internationally recognised for their experience with the ‘psoriasis plaque test’ - which is clinically validated and utilised by a number of leading dermatology companies. The study is designed to assess the safety and efficacy of BTX 1308 on psoriasis plaques or lesions, with the ability to compare multiple formulations and test products at the same time, and on the same patient.

Botanix Founder and Executive Director Matt Callahan: “We are pleased to have enrolled and treated our first patient in the BTX 1308 psoriasis study. The unique design of this patient study which allows us to compare multiple drugs in the same patient at the same time, means that the treatment duration can be shortened, while the quality of data can also be enhanced.”

“BTX 1308 is our third product to commence a patient study in the last 12 months, which demonstrates our ability to rapidly add new indications to the pipeline, as we can leverage the studies already successfully completed with synthetic cannabidiol in acne and atopic dermatitis.”

The Phase 1b patient study will test BTX 1308 against a vehicle (placebo) and an active comparator in 15 patients at a single study site in Australia. Because all test articles are compared on psoriasis plaques on the same patient, at the same time, the study protocol is recognised as a powerful proof of concept tool by dermatology companies. The study is expected to take approximately 3 to 4 months to complete and data is expected to be available in 1Q CY2019.

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There is a significant unmet need for a safe and effective product for mild to moderate psoriasis, particularly a topical product that can modulate inflammation, address bacterial infection and potentially have an impact on the immune pathways associated with disease progression. BTX 1308 provides a potential treatment that addresses these three needs with a safety profile that ensures that it can be used for long periods in adolescents and adults.

About Botanix Pharmaceuticals

Botanix Pharmaceuticals Limited (ASX:BOT) is a clinical stage medical dermatology company based in Perth, Australia and Philadelphia, PA. The Company’s focus is the development of safe and effective topical treatments for acne, psoriasis, atopic dermatitis and other skin conditions. The active ingredient contained in Botanix products is a synthetic form of a widely studied natural compound. Treatment targets include inflammation, deterioration of the of the skin barrier, skin cell proliferation, pruritus (itch), excess sebum production and bacterial infection.

Botanix has an exclusive license to use a proprietary drug delivery system (Permetrex[TM] ) for direct skin delivery of active pharmaceuticals in all skin diseases. Botanix is working with multiple parties to test the application of Permetrex[TM] on both a fee-for-service and traditional license basis.

Botanix pursues a rapid clinical development strategy aimed at accelerating product commercialisation. The patient treatment duration of clinical studies is generally completed within a 4 to 12-week timeframe.

The Company completed its first acne patient studies with BTX 1503 in January 2018 and has commenced a Phase 2 clinical trial in June 2018 with completion expected in mid-2019. The Phase 1b BTX 1204 atopic dermatitis patient study concluded in June 2018 and preparation is underway for a Phase 2 clinical trial. The Phase 1b BTX 1308 psoriasis patient study commenced in 4Q CY2018.

To learn more please visit: https://www.botanixpharma.com/

For more information, please contact:

General enquiries Investor enquiries Media enquiries Matt Callahan Joel Seah Julia Maguire Botanix Pharmaceuticals Vesparum Capital The Capital Network Founder & Executive Director +1 215 767 4184 P: +61 3 8582 4800 P: +61 419 815 386 [email protected] [email protected] [email protected]