4D pharma’s Blautix has met its primary endpoint in the Phase II irritable bowel syndrome (IBS) trial of improving overall response rate (ORR) in IBS patients with either IBS-Constipation and IBS-Diarrhoea vs. placebo, although we note a lower level of significance (0.1) was used. Whilst this presents a statistical concern, the results do enough to show a efficacy signal in IBS and the observed ORR effect size demonstrated by Blautix vs. placebo is numerically comparable to other drugs approved solely in either IBS-C or IBS-D. There is currently no approved therapy for IBS-mixed but the safety profile of Blautix was also comparable to placebo, indicating a favourable safety profile that may provide future differentiation vs. current approved IBS drugs. We look forward to more detailed trial data expected by YE 2020. IBS is a vast market opportunity, and there is currently no approved disease modifying therapy available in any IBS subtype, any therapy that can treat all subtypes, or specifically addressing patients with IBS-mixed (fluctuating symptoms of constipation and diarrhoea), which represents c. 30% of all IBS patients. As such, Blautix has the potential to be a first-theclass drug, and management believe this data in its totality will be sufficient to progress the programme into a Phase III pivotal programme, whether independently or with a licensing partner (TBC). We note that 4D are in ongoing discussions with leading pharmaceutical developers in the IBS space, and data should be viewed with interest by potential partners