• First participants have been successfully dosed in a Phase I Clinical Trial of MAP 315, Microba’s lead  Therapeutic Program in Inflammatory Bowel Disease. 
• MAP 315, is a novel live biotherapeutic product being developed for the treatment of ulcerative colitis and  was discovered and developed using Microba’s data-driven Therapeutics Platform. 
• This milestone transitions Microba into a clinical stage drug development company with results from the  trial expected in December 2023. 

• A video presentation of this milestone by Microba CEO Dr Luke Reid and SVP, Therapeutics Prof Trent  Munro can be viewed here https://ir.microba.com/presentations/

Professor Trent Munro, SVP of Therapeutics at Microba said: “Microba has now matured into a clinical stage drug  development company. I am proud of our team and what we have built to bring novel microbiome drugs all the way from  human-data guided discovery, through to an orally delivered drug product now dosed in a first in human clinical trial. We  are uniquely positioned at the forefront of drug development from the microbiome and excited about the future potential  impact of MAP 315 as a new treatment for Inflammatory Bowel Disease sufferers.” 

The Phase I clinical trial is a randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability and  pharmacokinetics of MAP 315 in 32 healthy adults. The trial is being conducted by Nucleus Network in Melbourne,  Australia, under the Company’s Human Research Ethics Committee (HREC) approval and in alignment with formal feedback  received from an FDA pre-IND engagement. 

MAP 315 Phase 1 Clinical Trial Details 

The clinical trial is titled “A Phase 1, Randomised, Double-Blind, Placebo- Controlled, Study to Evaluate the Safety,  Tolerability and Pharmacokinetics of MAP 315 in Healthy Adults”. The study will enroll 2 cohorts of 16 participants each,  who will be randomised 3:1 to receive MAP 315 or its matching placebo for 14 consecutive days (2 weeks). Results from the  trial are expected to be available in December 2023. Full study details can also be found in the Australian New Zealand  Clinical Trials Registry (ANZCTR) under study ID: ACTRN12623000291684. 

Microba’s Novel Drug Candidate MAP 315 

MAP 315 was identified using Microba’s unique analysis of its large proprietary human databank, demonstrating that this  previously uncharacterised and novel bacterial species is commonly observed in healthy individuals but consistently  deficient in individuals with IBD. Subsequent pre-clinical investigation of MAP 315 through both in vitro and in vivo models  demonstrated that MAP 315 promotes epithelial restitution and mucosal healing - biological activities that are critical for sustained disease remission but not adequately addressed through existing therapy. 

MAP 315 is a live biotherapeutic product (LBP) consisting of lyophilised bacteria in an enteric coated capsule which is orally  administered and being developed as an investigational product for the treatment of ulcerative colitis (UC). Microba  worked in partnership with leading microbiome contract drug manufacturer Bacthera to produce GMP compliant MAP 315  at large-scale in their state-of-the-art facilities in Europe to supply material for the MAP 315 clinical trial. 

Inflammatory Bowel Disease – Large unmet need & commercial opportunity 

IBD causes prolonged inflammation of the digestive tract and now affects more than 7 million people globally, with this  number increasing each year1. Ulcerative colitis (UC) is one of the two major forms of IBD, which results in inflammation  and ulcers (sores) in the digestive tract, causing a debilitating chronic condition. Patients are currently treated with anti 

inflammatory and immunomodulatory medication to dampen the disease and control symptoms, often with significant side  effects. These available treatment options commonly fail, with more than 50% of patients unable to achieve sustained  remission2, which sees them experiencing regular episodes of inflammation, diarrhoea, bleeding and abdominal pain3, with  as many as 25% of patients requiring hospitalisation4. The market for UC treatment was valued at US$7.5 billion in 2020 and  is forecast to grow to US$10.8 billion by 20305. Microba’s novel drug candidate MAP315 presents an opportunity to  improve the current standard of care and treatment for millions of people suffering from the debilitating effects of UC. 

Therapeutic Platform & Programs 

There is a growing body of evidence that the gut microbiome plays a central role in the maintenance of health and the  development of chronic disease. With microbiome-based therapeutics now in clinical development and the first FDA  approvals, these novel drugs represent an exciting new opportunity for the treatment of chronic diseases that are  underserved by current pharmaceuticals. 

Microba is at the forefront of this field using its advanced proprietary metagenomics technology developed by leading  Australian researchers in the top 1% of cited researchers globally. Using this technology, Microba has established a data driven platform for drug discovery and development from the human gut microbiome. This platform leverages a large,  growing, proprietary databank collected through the Company’s Microbiome Testing Services, and is generating multiple  potent therapeutic candidates to address chronic diseases. Microba has established three therapeutic programs spanning  IBD, Immuno-Oncology and Autoimmune Diseases, with lead candidate MAP 315 under the Company’s IBD program the  first program to enter human clinical trials.