The information contained within this announcement is deemed by the Company to constitute inside information stipulated under the Market Abuse Regulation (EU) No. 596/2014.  Upon the publication of this announcement via the Regulatory Information Service, this inside information is now considered to be in the public domain.

4D pharma plc

(the "Company" or "4D")

Issue of Equity

4D pharma plc (AIM: DDDD), a pharmaceutical company focusing on the development of live biotherapeutics, announces that it allotted 635,692 new ordinary shares on 23 August 2017.               

The allotment represents deferred consideration in respect of the acquisition of the entire issued share capital of 4D Pharma Cork Limited (formerly Tucana Health Limited), which completed in February 2016; and follows the achievement of 4D Pharma Cork's initial milestone.

The milestone achieved reflects the technical validation of the MicroDx diagnostic platform enabling the stratification of IBS patients.  MicroDx has been designed to diagnose, stratify and monitor the treatment of patients based on their gut microbiome, the bacteria which colonise the human gastrointestinal tract. 

IBS is a functional bowel disorder characterised by discomfort, pain and changes in bowel habits, affecting 10-15% of the population.  It is subdivided into constipation (C), diarrhoea (D) and mixed (M) subtypes. 

The MicroDx platform has now completed its first clinical trial, validating the platform (the 'MicroDx trial').  The MicroDx trial profiled 80 clinically diagnosed IBS patients (recruited across all subtypes according to the Rome III/IV criteria) and 65 healthy volunteers, with MicroDx demonstrating the ability to differentiate between IBS patients and healthy volunteers.  As reported earlier in the year, this research had also given insights into the disease, such as the marked difference between the microbiome of healthy volunteers and IBS patients, and the commonalities of microbiome across all IBS subtypes.

The differences between healthy and IBS patients demonstrated in the MicroDx trial support the findings from the phase I Blautix trial, which primarily demonstrated the safety and tolerability of Blautix, but also showed a positive trend of an increasing stability and diversity of the microbiome of patients on Blautix as opposed to placebo.  The combination of these results provides further evidence implicating the microbiome as a potential causative or exacerbating factor of IBS, and gives 4D further confidence as the Company progresses towards the phase II trial of Blautix.  Additionally, with 80 well-defined IBS patients, the MicroDx trial also provides access to patients eligible for the upcoming phase II Blautix trial.

Duncan Peyton, 4D's Chief Executive Officer, commented: "These results confirm the potential of the  microbiome as a means to provide rapid and accurate diagnosis of disease.  In respect of IBS, a disease which affects up to 10-15% of the population, MicroDx may offer clinicians a tool to provide diagnosis, and in turn provide better outcomes for the patients of what is a misunderstood disease.  The work carried out by the 4D team in Cork has also built further evidence supporting the use of a live biotherapeutic across all subtypes of the disease, and the trial itself provides a well understood cohort to potentially kick start our phase II Blautix trial.  Further, having validated the platform in IBS, we will look to develop MicroDx across other disease areas, in conjunction with the upcoming trials of our live biotherapeutics in cancer and asthma." 

The new 4D ordinary shares have been allotted for an aggregate value of €2.6 million* (at £3.7575 per 4D share, being the average mid-market price of a 4D share for the five business days immediately preceding the date of allotment).  Application has been made for the new 4D shares to be admitted to trading on AIM ("Admission"), and it is expected that Admission will take place on 31 August 2017.

Following Admission, the Company's issued share capital will consist of 65,493,842 ordinary shares.  There are no ordinary shares held in treasury.  Therefore, in accordance with the FCA's Disclosure and Transparency Rule 5.6.1, the Company confirms that, following Admission, the total number of voting rights in the Company will be 65,493,842.

*Exchange rate used: £1 : €1.0885

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About 4D

Founded in February 2014, 4D is a world leader in the development of live biotherapeutics, a novel and emerging class of drugs, defined by the FDA as biological products that contain a live organism, such as a bacteria, that is applicable to the prevention, treatment or cure of a disease.  4D has developed a proprietary platform, MicroRx, that rationally identifies novel bacteria that have a precise and evolved therapeutic effect.  All of 4D's live biotherapeutic products are orally delivered single strains of bacteria that are naturally found in the healthy human gut.  4D currently has a pipeline of 13 preclinical programmes, covering disease areas such as rheumatoid arthritis, multiple sclerosis and cancer, and is currently conducting subject trials in Irritable Bowel Syndrome and Paediatric Crohn's Disease.  The programmes in Paediatric Ulcerative Colitis and Paediatric Crohn's Disease have both been granted Orphan Drug Status by the FDA.