Interim results

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", "4D Pharma" or "the Company")

Interim results for the six months ended 30 June 2017

4D pharma plc (AIM: DDDD), a pharmaceutical company focussing on the development of live biotherapeutics targeting important new therapeutic areas, is pleased to announce the interim results for the Company and its subsidiaries (together "the Group") for the six months ended 30 June 2017.

Financial highlights

· Net assets as at 30 June 2017 of £75.3 million (30 June 2016: £92.1 million and 31 December 2016: £86.5 million)

· Cash and cash equivalents and short-term deposits at 30 June 2017 of £59.8 million (30 June 2016: £75.4 million and 31 December 2016: £68.8 million)

· Loss attributable to the owners of the parent undertaking for the six months ended 30 June 2017 of £11.3 million* (30 June 2016: £4.6 million and 31 December 2016: £10.3 million)

· Research and development expenditure for the six months ended 30 June 2017 of £8.3 million (30 June 2016: £4.1 million and 31 December 2016: £10.2 million)

Operational and clinical highlights

· In relation to MicroDx, 4D Pharma Cork's diagnostic platform enabling the stratification of IBS patients, interim analysis of data generated in a clinical study demonstrating the ability to differentiate between IBS patients and healthy volunteers, the commonalities of microbiome across all IBS subtypes, and the ability to differentiate between IBS patients and healthy volunteers based on metabolite profiles

Since the period end

· Completion of the first clinical trial of the MicroDx diagnostic platform, validating the platform and representing achievement of the initial milestone from the acquisition of 4D Pharma Cork Limited in February 2016

* Note: this includes a £3.5 million non-recurring charge in relation to the successful completion of the first milestone for 4D Pharma Cork Limited.

Chairman's statement

David Norwood, Chairman of 4D pharma, commented: "2017 has seen 4D continue to make significant progress expanding the scope of our research, developing our manufacturing capability and progressing through the clinic towards our aim of delivering live biotherapeutics in a number of exciting disease areas. I would once again like to thank the Board, our employees and our shareholders for their continued support."

For further information please contact:

For further information please also visit: www.4dpharmaplc.com.

Chairman and Chief Executive Officer's Joint Review

David Norwood, Non-executive Chairman and Duncan Peyton, Chief Executive Officer

Overview

The development of the microbiome and its exploitation as a therapeutic continues at an unprecedented pace, and 4D continues to lead this exciting new area through developing science and delivering therapies.

For over a century it has been well understood that a single bacteria can affect our health; Robert Koch, the founding father of microbiology, identified pathogenic bacteria as the causative agents of several important diseases, demonstrating the negative impact of a single strain on our health. However, through recent advances made by 4D we are now starting to understand the positive impact of a single strain on our health.

Whilst there has long been a correlation between the presence or absence of certain bacteria and disease, it is only now that we are starting to see the influence that specific strains of bacteria can have on our immune system, increasingly acknowledged as being central to the pathology of many diseases. It is only with the advent of groundbreaking technological advances in the fields of genetics and molecular and cell biology that 4D is starting to uncover the key role bacteria play in our health, through the development and maintenance of a healthy immune system.

The understanding of the interaction between the host and the bacteria in the gut is central to the approach at 4D. As with traditional drug development, we look at the host, understanding the pathways associated with disease; we then look at bacteria isolated from a healthy human microbiome and understand whether or not they can impact those pathways. If we can overlay the bacteria and the pathway, we have the starting point for a 4D therapeutic.

This targeted approach is the backbone of 4D's proprietary platform, MicroRx. To date, MicroRx has led 4D to identify 17 therapeutic single strains that act individually across a wide range of diseases including cancer, asthma and autoimmune disorders. This research has shown that whilst some bacteria act on the same pathways as "traditional" blockbuster drugs, others appear to act via novel mechanisms. This discovery opens up the possibility of developing better ways to treat diseases where conventional therapies have significant side effects or low efficacy, in addition to breaking new ground in areas of significant unmet clinical need.

In addition to direct therapeutic effect, 4D is beginning to understand the wider impact of our single-strain therapeutics. Leading from our pre-clinical work we are seeing how a single strain can positively impact the microbiome in patients, increasing the stability and diversity of the range of bacteria found in the gut. This may provide answers as to how to improve the efficacy and response rates of existing traditional pharmaceuticals and newer immunotherapies.

Our recent progress and continued investigations into the microbiome are fundamentally changing our understanding of disease in terms of causation, diagnosis and potential therapeutic approaches.

The microbiome may be a new breakthrough for the pharmaceutical industry, but unlike so many potential new breakthroughs, through our understanding of research, development, manufacturing and delivery, we believe manipulation of the microbiome and our health through 4D's novel therapeutics is within reach in the next few years.

Developing science

We continue to invest in our understanding of the microbiome.

We have over 65 scientists in house and collaborations with leading academic institutions, working to uncover new possibilities for therapeutics as well as how we translate this research though the clinic to the patient.

We are targeting a new, safer approach to drug development.

One of the key areas of interest within the development of 4D's therapeutics is their exceptional safety profile.

Traditionally, the pharmaceutical industry struggled with the issue of relative benefit over side effects and toxicity. It is common within the pharmaceutical industry that drug development fails due to safety and toxicity issues; it is also common that those drugs that do gain approval and come to the market do so with severe warnings over side effects. This is not restricted to those drugs that treat rare or life-threatening conditions, but includes diseases that are becoming more commonplace, such as Crohn's and rheumatoid arthritis, that are treated by some of the biggest selling drugs on the market.

At 4D, our bacteria are commensal, being isolated from healthy humans, and therefore present a lower risk from a safety standpoint. Throughout the development of this novel and emerging field, 4D has continually interacted with the regulators, particularly on matters of safety, as we target bringing our drugs to market. This position has been further reinforced by our findings from patients in the clinic, where our products have presented a similar safety profile to placebo.

Our learning of disease continues.

We have seen from 4D Pharma Cork's work in irritable bowel syndrome ("IBS") the importance of the role of the microbiome both in the causative element of the disease and also in identifying signatures to enable us to diagnose and stratify patients efficiently. This work is not only important in the upcoming phase II trial of Blautix, our treatment for IBS, but will also allow 4D to look at using the microbiome as a diagnostic across our portfolio.

Through our collaboration with Baylor College of Medicine, 4D is furthering the understanding of the role of the microbiome as a key protagonist in diseases such as asthma. This work and learning has led our team to accelerate the asthma programme through development, targeting the clinic next year.

We are actively targeting cancer.

4D will aim to start a first-in-man cancer monotherapy trial later this year. This trial is unusual in that, rather than beginning our clinical studies in patients who have received multiple conventional therapies, we are planning to dose patients who have recently been diagnosed with cancer and are "treatment naïve". This approach is possible due to the anticipated safety profile of our therapeutic and will allow us to investigate the potential impact of our drug on the immune system at an earlier stage of the disease.

The trial is the culmination of just over two years' work from the point when our research team in Aberdeen first identified strains within the human gut that were immune-stimulatory and hypothesised the potential role of these strains in immuno-oncology. Since this discovery in May 2015, the team has been able to take that work forward from discovery, through industry standard models, to understand the potential efficacy, to the point where 4D has drug product ready for trial.

To put this achievement of the 4D team in perspective, the majority of cancer drugs can take up to eight years (and perhaps longer) before they can be given to a patient, and generally those patients have had several failed therapeutic interventions prior to this, and are therefore compromised in terms of the response of the immune system. The speed of progress to the clinic and design of the trial is a signal of the safe, cost-effective and rapid development of this new generation of drugs.

At 4D we believe that the microbiome has a greater role to play in immunology, not only in how our drugs can potentially impact cancer as a standalone therapy, but also in understanding their potential as adjuvants or combinations to existing therapies, and 4D will continually look at how to expand and integrate into this space over the coming months.

We continue to lead the way in targeting new disease areas.

The microbiome is associated with the gut; linking this to diseases of the gut, such as IBS, inflammatory bowel disease or C. difficile infections, is common sense, and in a sense obvious. Indeed, 4D's initial research and development programmes targeted IBS, Crohn's disease and ulcerative colitis.

However, at 4D, as we grew our understanding of the role bacteria play and the impact they have with the immune system, we developed our research and learning to investigate the impact beyond the gut, moving into autoimmune conditions and cancer. This drive forward has not stopped; 4D, alongside many leading institutions, has begun investigations into how our microbiota interact with the gut-brain axis. This work could lead to new approaches to those diseases which to date science has simply failed to address, such as Parkinson's disease, Alzheimer's and autism. Whilst this work is still at an early stage, at 4D we are beginning to observe similar patterns to our earlier work, with single strains being able to influence many known pathways associated with these diseases, as well as opening up new possibilities.

Our intellectual property estate is the largest in the field.

With our ongoing efforts across research, development and clinical studies, 4D continues to build on our extensive patent portfolio. 4D now holds 32 patent families, with 86 granted patents and 170 patent applications, including our most recent filings in the neurodegeneration space.

Delivering therapies

Central to the development of any new scientific breakthrough is the ability to reliably and repeatedly manufacture product.

From inception, 4D understood the need for manufacturing to keep pace with the momentum generated by our research teams. After working with a number of outsourced partners on the initial projects, 4D acquired the production assets of Instituto Biomar in León, now our primary site for development and manufacturing.

4D pharma León is hugely significant, as it is a cGMP-approved site for the manufacture of live biotherapeutics. It has the capacity to run to 20 million capsules per annum, as well as the infrastructure and capability to perform scale-up from glassware in the research labs, through development and pilot scale.

To date our development team at 4D has taken five different programmes from the research lab to clinical/production scale, resulting in a product with up to 24 months' stability. The ability to control our development schedules and end up with stable, reproducible product gives 4D the confidence that going forward we can address all issues within our existing and future programmes to deliver product to the clinic and ultimately the patient.

Our understanding of the relationship between the bacteria in our gut and the ability to translate this into a stable therapeutic demonstrates that 4D's therapeutics are a reality. The ability at this stage of our development to be confident of succeeding in taking our research to reliably and repeatedly deliver drug to patients is a strong position on which to build.

Going forward

4D has a busy schedule of clinical trials coming up.

The next 12-18 months includes commencement of first-in-man trials in cancer and asthma, and commencement of the phase II trial for Blautix, as well as the conclusion of our phase I study in Paediatric Crohn's and commencement of a phase II study.

We will also continue our work in new fields, further exploring and understanding our efforts in areas such as neurodegeneration, and how our therapeutics can work alongside and potentially improve existing therapeutic approaches.

From inception in 2014, 4D has made solid progress. The Company has a class-leading platform which to date has generated 17 programmes across many disease areas. Two programmes have already been in patients and we have two first-in-man studies about to commence in cancer and asthma, and importantly 4D has the ability to develop, manufacture and deliver our products.

4D has a strong position to build on. We recognise that the field is still evolving, but we also recognise that 4D is leading its evolution.

David Norwood

Non-executive Chairman

Duncan Peyton

Chief Executive Officer

27 September 2017

Group Statement of Total Comprehensive Income

For the six months to 30 June 2017

Group Statement of Financial Position

At 30 June 2017

Approved by the Board and authorised for issue on 27 September 2017.

Duncan Peyton

Director

27 September 2017

Group Statement of Changes in Equity

For the six months to 30 June 2017

Group Cash Flow Statement

For the six months to 30 June 2017

Notes to the Interim Financial Report

For the six months ended 30 June 2017

1. Basis of preparation

The Group's half-yearly financial information, which is unaudited, consolidates the results of 4D pharma plc and its subsidiary undertakings up to 30 June 2017. The Group's accounting reference date is 31 December. 4D pharma plc's shares are quoted on the AIM Market of the London Stock Exchange (AIM).

The Company is a public limited liability company incorporated and domiciled in the UK. The consolidated financial information is presented in round thousands of Pounds Sterling (£000).

The financial information contained in this half-yearly financial report does not constitute statutory accounts as defined in section 434 of the Companies Act 2006. It does not therefore include all of the information and disclosures required in the annual financial statements.

The financial information for the six months ended 30 June 2016 and 30 June 2017 is unaudited.

Full audited financial statements of the Group in respect of the year ended 31 December 2016, which received an unqualified audit opinion and did not contain a statement under sections 498(2) or (3) of the Companies Act 2006, have been delivered to the Registrar of Companies.

The accounting policies used in the preparation of the financial information for the six months ended 30 June 2017 are in accordance with the recognition and measurement criteria of International Financial Reporting Standards as adopted by the European Union ("IFRS") and are consistent with those which will be adopted in the annual financial statements for the year ending 31 December 2017.

Whilst the financial information included has been prepared in accordance with the recognition and measurement criteria of IFRS, the financial information does not contain sufficient information to comply with IFRS.

4D pharma plc has not applied IAS 34 Interim Financial Reporting, which is not mandatory for UK AIM-listed groups, in the preparation of this interim financial report.

2. Going concern

Having prepared management forecasts and made appropriate enquiries, the directors are satisfied that the Group has adequate resources for the foreseeable future as the Group is in the start-up stage of its business lifecycle. Accordingly they have adopted the going concern basis in preparing the financial information.

3. Taxation

The tax credit is made up as follows:

4. Loss per ordinary share

(a) Basic and diluted

The basic and diluted loss per share are the same as the effect of share options is anti-dilutive.

(b) Adjusted

Adjusted loss per share is calculated after adjusting for the effect of non-recurring expenses in relation to the reassessment of the contingent liability.

Reconciliation of adjusted loss after tax:

5. Non-recurring costs

As detailed in post-balance sheet events (see note 7) and other payables (see note 6) on 23 August 2017 contingent consideration became due following the achievement of 4D Pharma Cork Ltd's initial milestone.

The contingent liability was initially calculated upon the acquisition based on the discounted probability of the potential liability at the time of acquisition. With the successful completion of the first milestone the management have had to re-assess the probability of success of subsequent milestones and therefore increase the contingent liability. This has resulted in the non-recurring cost in the period to 30 June 2017 of £3.474 million.

6. Other payables

Contingent consideration:

The above contingent consideration relates to the amounts due on the remaining contingent milestones in relation to the acquisition of Tucana Health Limited (now 4D Pharma Cork Limited) on 10 February 2016. As detailed in note 7, the first milestone has been achieved and so a reassessment has been made of the potential liability arising on the discounted probability of the remaining milestones.

7. Post-balance sheet events

On 23 August 2017 635,692 new ordinary shares were issued. The allotment represents contingent 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.

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) and were admitted on 31 August 2017.

Following Admission, the Company's issued share capital is 65,493,842 ordinary shares.