Announcement PDF ASX ANNOUNCEMENT 14 February 2022 Supplementary Announcement: Full clinical results cement product expansion plans Highlights ● ● ● 4-arm randomized, double-blind, placebo-controlled study completed on acne patients cements viability and commercial value of new product; Biome AcneTM Probiotic Results for the probiotic arm demonstrate a 38.89% decrease in acne lesions at 8 weeks These results reinforce the commercial potential of Biome AcneTM Probiotic which is expected to launch in Q4 FY22 Microbiome health company Biome Australia Limited (ASX: BIO) (‘Biome’ or ‘the company’) is pleased to provide additional information pertaining to recently announced clinical trials results at the request of the ASX. On the 9th of February 2022, the company announced the results from the probiotic arm of the recently published double-blind, randomised, placebo-controlled clinical trial that analysed the efficacy of specialised probiotic strains (alongside two other interventions) on mild to moderate acne which have been peer-reviewed and published in the Journal of Dermatology and Therapy, titled ‘Facial Acne: A Randomized, Double-Blind, Placebo-Controlled Study on the Clinical Efficacy of a Symbiotic Dietary Supplement’1. The company is pleased to now release detailed results from the entire trial, encompassing each of the four arms (“Groups”). 1 Rinaldi, F., Marotta, L., Mascolo, A., Amoruso, A., Pane, M., Giuliani, G., & Pinto, D. (2022). Facial Acne: A Randomized, Double-Blind, Placebo-Controlled Study on the Clinical Efficacy of a Symbiotic Dietary Supplement. Dermatology and Therapy. https://doi.org/10.1007/s13555-021-00664-z 1 Trial overview The trial was conducted by Giuliani S.p.A in Italy and tested the effectiveness of three different treatments on mild to moderate acne on 114 subjects over four Groups. Each of the subjects were dosed once daily for eight weeks with their corresponding Group’s study treatment and results were compared with the Control Group. Group I - 28 subjects: Placebo / Control Group Group II - 30 subjects: A dietary supplement containing probiotics (Bifidobacterium breve BR03, Lacticaseibacillus casei LC03, and Ligilactobacillus salivarius LS03) & botanical extract (lupeol from Solanum melongena L. and Echinacea extract) Group III - 29 subjects: A botanical extract alone containing lupeol from Solanum melongena L. and Echinacea extract Group IV - 27 subjects: A probiotic alone containing Bifidobacterium breve BR03, Lacticaseibacillus casei LC03, Ligilactobacillus salivarius LS03 The clinical results pertinent to Biome Australia are solely those reported on Group IV vs Control Group and cement Biome’s decision to proceed with the launch of Biome AcneTM Probiotic in Q4 2022. The Study’s endpoints were evaluated at each post-baseline visit and included the following. - - The percent change from baseline in facial comedones, papules, pustules, and nodules, measured using the global acne grading system (GAGS) score that gives a weight to each region (face and back) with a severity score Porphyrins, evaluated by the VISIA system Erythema and desquamation, measured according to a four-point qualitative scale. Sebum level, measured by a microcamera equipped with 200× Optic system Microbial dysbiosis, expressed as the relative abundance of bacterial DNA of main bacterial species on the skin: Cutibacterium acnes, Staphylococcus epidermidis, and Staphylococcus aureus Trial results Full results from the Trial and each Group’s performance against the Study’s endpoints are included in annexure A. 2 Group IV results (probiotics alone) Using the global acne grading system (GAGS) score, results from Group IV vs Control Group showed that at week 4, there was a 31.11% (p < 0.05) decrease in the number of superficial inflammatory acne lesions in the subjects taking probiotics compared to placebo (-10%) and at 8 weeks there was a 38.89% (p < 0.05) decrease vs placebo (18.89% decrease). The mean erythema score was significantly reduced after 8 weeks of treatment with probiotics (T0 1.82 ± 0.06 vs T2 0.73 ± 0.74, p < 0.05), while no reduction was reported in the placebo Group. There was also a significant reduction in the abundance of the main bacteria implicated in the pathogenesis of acne, Cutibacterium acnes (26.8 vs 21.7 log RA, p < 0.01), in those in Group IV at the end of the study, providing evidence for the ability of this oral probiotic to impact the skin microbiome. Group II and Group III also reported a decrease in the number of superficial inflammatory acne lesions at 8 weeks recording -56.67% and -40% respectively. The two Groups also reported a significantly reduced sebum secretion rate and mean erythema score of 0.27 ± 0.45 (p < 0.05) for Group II and 0.50 ± 0.63 (p < 0.05) for Group III. The mean erythema score at baseline for all Groups was 1.82 ± 0.06. Biome AcneTM Probiotic to launch in Q4 FY22 The results of the probiotic arm support new product opportunities that are aligned with Biome’s expertise: specialised probiotic products. This trial has helped to establish the viability, efficacy and commercial value of Biome Australia’s latest product, Biome AcneTM Probiotic, formulated using the probiotic strains tested on the 27 subjects. These significant clinical results cement the company’s growth strategy to launch well-researched and novel probiotic products that address prevalent health concerns in new ways and expand its product portfolio. Production and manufacturing of Biome AcneTM Probiotic remains on track and upon launch will be sold via the company’s extensive network of over 2300 community pharmacies and independent health practitioners across Australia. It will also be launched into the UK and New Zealand markets as Biome DermaTM. -ENDS- 3 Disclaimer: The information within this document is for educational purposes only, and any information or products described within are not intended to diagnose, treat, cure or prevent any disease. The information contained in this document is in no way intended to be prescriptive or replace medical advice by a healthcare physician. Approved for release by the Biome Australia Board of Directors. About Biome Australia Limited Biome Australia develops, licenses, commercialises and markets innovative, evidence-based live biotherapeutics (probiotics) and complementary medicines, many of which are supported by clinical research. Biome aims to improve health outcomes and quality of life, and make its products accessible to all. Incorporated in Australia in 2018, Biome distributes locally and abroad. In partnership with some of the world's leading organisations in microbiome research and development, Biome produced several unique live biotherapeutic (probiotic) products with innovative delivery technologies that improve their stability and efficacy to create its flagship range of complementary medicines: Activated Probiotics®. Supported by clinical research, including randomised double-blind placebocontrolled trials, Activated Probiotics help prevent and support the management of various health concerns, including low mood and sleep, bone health, iron malabsorption, mild eczema and IBS. Through practitioner-only distribution, Biome is committed to educating health professionals on the newfound systemic health effects of the gut microbiota, helping them to provide innovative, evidence-based natural medicines for the management of some of humanity's most prevalent and chronic health concerns. Biome also develops, licenses and distributes a scientifically formulated, organic nutraceutical range, Activated Nutrients® and a sports performance and recovery range, Activated X Performance®, which is made exclusively for professional athletes. For more information visit: www.biomeaustralia.com 4 Investor Relations WE Communications Hannah Howlett +61 450 648 064 hhowlett@we-worldwide.com Media enquiries media@activated.co Forward looking statements This release may contain forward looking statements, including but not limited to projections, guidance on future revenues, earnings, other potential synergies and estimates and the future performance of Biome (Forward Looking Statements). Forward Looking Statements are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. Actual results, performance or achievements may differ materially from those expressed or implied in such Forward Looking Statements and any projections and assumptions on which these Forward Looking Statements are based. Such statements may assume the success of Biome's business strategies. You are cautioned not to place undue reliance on Forward Looking Statements. The Forward Looking Statements are based on information available to Biome as at the date of this release. Any Forward Looking Statements containing forward looking financial information provided in this release is for illustrative purposes only and is not represented as being indicative of Biome's views on its future financial condition and/or performance. The historic financial information for the September 2021 financial quarter and revenue figures for October and November 2021 have not been audited or reviewed by Biome's auditors. Such information should not be taken as a guide for future performance. Nothing in this release is a promise or representation as to the future. No representation or warranty, express or implied, is made as to the accuracy, likelihood of achievement or reasonableness of any Forward Looking Statements contained in this release. 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ANNEXURE A Results from Group IV (probiotics alone) Endpoint Results at 4 weeks Results at 8 weeks The percent change from baseline in the global acne grading system (GAGS) score −31.11% (p < 0.05) −38.89% (p < 0.05) Erythema score No statistically significant reductions The mean erytheme score at baseline for all groups was 1.82 ± 0.06 and reduced to 0.73 ± 0.74 (p < 0.05) for group IV Desquamation score No statistically significant reductions –33.30% (p < 0.01) Sebum secretion rate No statistically significant reductions Significantly reduced Porphyrin No statistically significant reductions No statistically significant reductions Microbial dysbiosis Significant (p < 0.01) decrease in C. acnes (from 26.8 to 24.2 log RA, respectively). No statistically significant changes to S. aureus or S. epidermis. Significant (p < 0.01) decrease in C. acnes (21.7 log RA). No statistically significant changes to S. aureus or S. epidermis. Results from Group II (probiotics and botanicals) Endpoint Results at 4 weeks Results at 8 weeks The percent change from baseline in the global acne grading system −36.67% (p < 0.05) −56.67% (p < 0.05) 6 (GAGS) score Erythema score No statistically significant reductions The mean erythema score at baseline for all groups was 1.82 ± 0.06 and reduced to 0.27 ± 0.45 for group II (p < 0.05) Desquamation score −33.30% (p < 0.05) –55.60% (p < 0.05) Sebum secretion rate No statistically significant reductions Significantly reduced Porphyrin No statistically significant reductions −45.49% (p < 0.05) Microbial dysbiosis Significant (p < 0.01) decrease in C. acnes (from 29.7 to 21.4 log RA, respectively). Significant (p < 0.01) decrease in C. acnes (8.8 log RA) S. aureus was significantly S. aureus was significantly (p < 0.05) reduced in group (p < 0.05) reduced (from 1.4 II (0.2 log RA) to 1.1 log RA) Significant (p < 0.05) No statistically significant increase in S. epidermidis changes to S. epidermis (from 0.6 to 1.2 log RA). Results from Group III (botanicals) Endpoint Results at 4 weeks Results at 8 weeks The percent change from baseline in the global acne grading system (GAGS) score −33.33% (p < 0.05) −40.00% (p < 0.05) Erythema score No statistically significant reductions The mean erythema score at baseline for all groups was 1.82 ± 0.06 and reduced to 0.50 ± 0.63 (p < 0.05) for group III Desquamation score No statistically significant –43.40% (p < 0.01) 7 reductions Sebum secretion rate No statistically significant reductions Significantly reduced Porphyrin No statistically significant reductions −34.25% (p < 0.01) Microbial dysbiosis No statistically significant changes to C. acnes or S. epidermis. No statistically significant changes to C. acnes S. aureus was significantly S. aureus was significantly (p < 0.05) reduced (0.7 log (p < 0.05) reduced (from 1.8 RA) to 0.9 RA) Significant (p < 0.05) increase in S. epidermidis was reported in group III (from 1.1 to 1.6 log RA) Results from Group I (placebo) Endpoint Results at 4 weeks Results at 8 weeks The percent change from baseline in the global acne grading system (GAGS) score No statistically significant reductions No statistically significant reductions Erythema score No statistically significant reductions No statistically significant reductions Desquamation score No statistically significant reductions No statistically significant reductions Sebum secretion rate No statistically significant reductions No statistically significant reductions Porphyrin No statistically significant reductions No statistically significant reductions Microbial dysbiosis No statistically significant changes No statistically significant changes 8