Biome Australia : Clinical Development Update

onlyBiome Australia Limited

Clinical useDevelopment

Update

ersonalBiome Australia Limited - 21 February 2022

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Clinical Overview

Biome Australia (ASX: BIO) is focusing on becoming a global leader in the complementary medicine industry, offering clinically-provencondition-specific probiotic products.

onlyBiome is supporting novel clinical research

The current ongoing clinical trials are being conducted by Biome's academic research partners La Trobe University and Federation University.

Expanding the evidence base of Biome's products is key to increasing health professional trust in product efficacy.

This strengthens one of Biome's key strategies, which is to promote the user commendation of its products alongside prescription medications for

specific health concerns in order to improve patient outcomes.

This level of research also solidifies Biome's competitive advantage and will support commercial growth opportunities for the business.

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CMA Industry Audit 2021 p. 2

CMA Industry Audit 2021 p. 5 (Biome Australia has access to 80.3% of CM market via pharmacy, health food stores, online, speciality retailers and direct selling)

Revenue up 100% in H1 FY22 vs PCP

2500+ distribution points and growing

7 out of 10 Australians regularly use a

complementary medicine1

Biome has the opportunity to access up to

80.3% of this addressable market2

Probiotics - a fast growing market

There is a strong body of literature supporting probiotic efficacy across multiple health conditions, elevating their position within conventional medicine settings. However, this evidence base requires deeper investigation which is specific to its intended application outside of general gastrointestinal health.

In 2020, probiotics were one of the top three fastest growing ingredients within complementary medicine year on onlyear according to the CMA Industry Report 2021.

Live biotherapeutics are the next stage of development within the probiotic category, which involves the development of targeted strains of live probiotic bacteria that support specific pathological processes and disease states.

useersonal(1)

(2)

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Study on osteoporosis

prevention

Study on subthreshold

depression

Study on paediatric

immune health

Clinical Trial Programs

The clinical trial programs currently underway will expand the evidence of efficacy of existing products to support new and more specific applications.

onlyThis research is helping to increase the validity of a number of non-pharmaceutical based interventions for key chronic health conditions with reduced side effects and lower risk profiles.

Biome's clinical pipeline currently includes

useersonalBiome's Activated Probiotics range has 13 condition targeted probiotics ranging from eczema, bone health, asthma and other conditions that are traditionally supported by prescription medications and community pharmacies.

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Current evidence of efficacy of existing products

Products undergoing additional research were previously brought to market based on the following clinical research

only	Product name	Evidence	Subject of the
			evidence
	Biome	Publication:	Exact
	Lift	Marotta A, Sarno E, Casale A Del, Pane M, Mogna L, Amoruso A, et al. Effects of	combination of
	probiotics on cognitive reactivity, mood, and sleep quality. Front Psychiatry.
	Probiotic	probiotic strains
	2019;10(164):1-11.	used in Biome
			Lift
use
Biome	Publication:	Exact
	Osteo	Jansson PA, Curiac D, Lazou Ahrén I, Hansson F, Martinsson Niskanen T, Sjögren K,	combination of
	et al. Probiotic treatment using a mix of three Lactobacillus strains for lumbar
	Probiotic	probiotic strains
	spine bone loss in postmenopausal women: a randomised, double-blind,	used in Biome
		placebo-controlled, multicentre trial. Lancet Rheumatol [Internet].	Osteo
		2019;1(3):e154-62.
ersonal	Biome	Publication:	Specific probiotic
Daily Kids	Gawrońska A, Dziechciarz P, Horvath A, Szajewska H. A randomized double-blind	ingredients
placebo-controlled trial of Lactobacillus GG for abdominal pain disorders in
Probiotic	within Biome
	children. Aliment Pharmacol Ther. 2007;25(2):177-84	Daily Kids
		Publication:
		Liu S, Hu P, Du X, Zhou T, Pei X. Lactobacillus rhamnosus GG supplementation for
		preventing respiratory infections in children: A Meta-analysis of Randomized,
		Placebo-controlled Trials. Indian Pediatr [Internet]. 2013 Apr 25;50(4):377-81, 3.
		Publication:
		Szajewska H, Canani RB, Guarino A, Hojsak I, Indrio F, Kolacek S, et al. Probiotics for
		the Prevention of Antibiotic-Associated Diarrhea in Children. J Pediatr
		Gastroenterol Nutr. 2016 Mar;62(3):495-506.
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