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Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
---|---|---|---|---|---|
4d Pharma Plc | LSE:DDDD | London | Ordinary Share | GB00BJL5BR07 | ORD 0.25P |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 16.36 | 0.00 | 00:00:00 |
Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
---|---|---|---|---|---|
0 | 0 | N/A | 0 |
TIDMDDDD
RNS Number : 2473C
4d Pharma PLC
28 September 2018
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 2018
4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics, is pleased to announce the interim results for the Company and its subsidiaries (together "the Group") for the six months ended 30 June 2018.
Financial highlights
-- Net assets as at 30 June 2018 of GBP58.7 million (30 June 2017: GBP75.3 million and 31 December 2017: GBP69.8 million)
-- Cash and cash equivalents and short-term deposits at 30 June 2018 of GBP36.6 million (30 June 2017: GBP59.8 million and 31 December 2017: GBP50.0 million)
-- Loss attributable to the owners of the parent undertaking for the six months ended 30 June 2018 of GBP11.3 million (30 June 2017: GBP11.3 million* and 31 December 2017: GBP19.4 million*)
-- Research and development expenditure for the six months ended 30 June 2018 of GBP11.8 million (30 June 2017: GBP8.3 million and 31 December 2017: GBP16.9 million)
Operational and clinical highlights
-- Entering into clinical collaboration agreement with subsidiary of MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA) to conduct a clinical trial evaluating the combination of KEYTRUDA(R) (pembrolizumab), an anti-PD-1 therapy marketed by MSD, and 4D's Live Biotherapeutic candidate MRx0518 in patients with solid tumours; the phase I study will evaluate safety, tolerability and preliminary clinical benefit of the combination of KEYTRUDA(R) with MRx0518 in patients who progressed on prior PD-1 inhibitor therapy with renal, bladder, melanoma and non-small cell lung cancer
-- Clearance by the Medicines and Healthcare Products Regulatory Agency ("MHRA") of the Clinical Trial Application for MRx0518, the first Live Biotherapeutic trial in cancer; the first-in-human, two-part phase Ib study will evaluate the safety, tolerability and anti-tumour immuno-modulatory effects of MRx0518 in patients with multiple solid tumour types
-- Clearance by the US Food and Drug Administration ("FDA") of an Investigational New Drug Application for Blautix, the Group's Live Biotherapeutic for the treatment of Irritable Bowel Syndrome ("IBS"); the double-blind, placebo-controlled multicentre phase II study will evaluate the efficacy and safety of Blautix in patients with IBS with constipation ("IBS-C") and IBS with diarrhoea ("IBS-D")
-- Clearance by the MHRA and the Health Products Regulatory Authority ("HPRA") to commence the phase II study of Blautix at sites in the UK and Ireland
Since the period end
-- Positive top-line results for the Phase Ib study of the Company's Live Biotherapeutic Thetanix in paediatric patients with Crohn's disease; achieving the primary objective of demonstrating that Thetanix was well tolerated with a good safety profile
* Note: this includes a GBP3.5 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: "Through the successful development of its clinical programmes in the first half of 2018, the Company continues to lead the development of Live Biotherapeutics, as we seek to secure robust clinical data to support the use of this new class of drugs across multiple indications, and from there to progress towards our goal of producing Live Biotherapeutics as safe and effective therapies. I would once again like to thank the Board, our employees and our shareholders for their continued support."
For further information please contact:
4D +44 (0)113 895 0130 Duncan Peyton, Chief Executive Officer Zeus Capital Limited - Nomad and Joint Broker Dan Bate / Jordan Warburton / Jamie Peel +44 (0)161 831 1512 Bryan Garnier & Co. Limited - Joint Broker Dominic Wilson / Phil Walker +44 (0)20 7332 2500
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
The microbiome
Whilst 4D is founded on science, innovation and forward thinking, it is history that tells us the most.
The work of von Behring and the development of serum therapy evolved through decades of research into the multi-billion dollar industry of antibody technology. The approval of Epogen in 1989 is another example, beginning in the 17th century with the first blood transfusions in animals that eventually led to the development of Epogen, one of the first drugs to come out of the biotech industry. Both the development of antibodies and Epogen show us that from a complex source (whether this be blood or serum), through scientific endeavour, the focus ultimately ends on functional singularity.
At 4D we believe the development of Live Biotherapeutics is another example of form following function. From the initial reports of faecal matter used in the fourth century to treat food poisoning and diarrhoea, through the development and use of faecal transplants to treat clostridium difficile infection in the 1950s, we are now seeing the first Live Biotherapeutics entering the clinic. However, whereas early Chinese medicine and faecal transplants primarily treated gastrointestinal issues, the Live Biotherapeutics developed by 4D not only treat disease of the gut, but also address the major challenges of cancer, asthma and autoimmune conditions.
Today, rather than form following function, development of new drugs is arguably restricted by the common tools available (i.e. small molecules, proteins and antibodies), and could be considered function following form. Furthermore, drug development is targeted towards a single "validated" target, despite the knowledge that disease pathways do not operate in isolation. Considering this, it is perhaps no surprise that drugs have significant side effects, and that not all drugs are effective in all patients.
At the level of complex organisms, functionality exists at different levels (organs, tissues and cells), with cells being the simplest unit of independent functionality. Considering more recent history, if the functionality of a single cell can be harnessed in context (i.e. in the state in which it exists naturally), for example with Chimeric Antigen Receptor (CAR-T) or stem cell transplants, the effects are remarkable.
Within the microbiome, a single strain is the simplest cellular unit of functionality, and the microbiome is now understood to have significant functionality relevant to human health.
It is this potential that 4D is seeking: form following function, single strains impacting known disease pathways.
Working with pharma
As more research is done within the field of the microbiome and more papers are published, whether by third parties or those more recently published by the 4D research teams, the stronger the interest grows in the microbiome from the pharmaceutical industry.
The pharmaceutical industry is actively seeking out new innovation, not only in new therapeutics, but also in ways to enhance their existing therapies.
An example of this innovation is the clinical collaboration agreement 4D announced in early June, with a subsidiary of MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA).
This trial will evaluate MRx0518, 4D's lead oncology programme, which has shown therapeutic potential in a variety of tumour types in pre-clinical models and has the potential for synergy in combination with checkpoint inhibitor therapies. The phase I study will evaluate safety, tolerability and preliminary clinical benefit of the combination of KEYTRUDA(R) with MRx0518 in patients who progressed on prior PD-1 inhibitor therapy with renal, bladder, melanoma and non-small cell lung cancer.
Working within a developing regulatory and clinical environment
The microbiome and Live Biotherapeutics is an emerging field, and as such the regulations are evolving.
The US Food and Drug Administration ("FDA") issued a guidance document in 2016 relating to early stage clinical development of Live Biotherapeutic products. Following on from this, the European Pharmacopoeia has adopted three new quality standards for Live Biotherapeutics for human use in April 2018, with the new texts becoming effective in April 2019. 4D contributed to the development of these quality standards, acting as the UK's representative on the working party that developed the standards.
Throughout regulatory discussions relating to the development of 4D's own products, the focus has primarily been on the safety of patients, but also on developing the thinking surrounding Live Biotherapeutics through rigorous scientific debate. This interaction has led to 4D conducting phase I trials in patients as opposed to healthy subjects, not only demonstrating the potential to develop safer drugs, but also granting us an insight, albeit at a low level, into what we may expect to see in patient population earlier than under traditional development timelines.
Notwithstanding that our trials to date have been in patients, 4D is now preparing to expand these trials to generate data that is both significant and statistically relevant to further demonstrate the potential in the microbiome. An example of this is our phase II study in Irritable Bowel Syndrome ("IBS"), a double-blind, placebo-controlled multicentre trial currently being conducted with 500 patients across sites in Europe and the United States. As previously announced, this is the largest trial being conducted with a Live Biotherapeutic which, if successful, we believe will be sufficient to demonstrate efficacy and bring more understanding to the development of Live Biotherapeutics.
Developing a scientific viewpoint/standing
At 4D the bedrock of our business is research; only if 4D continues to build world-leading research will we ultimately succeed.
Whilst we continuously push our programmes through development, the innovative work of our scientific teams continues. One measure of success of our research is the development of our intellectual property estate and 4D continues to lead the field. We now have 355 granted patents across 46 patent families. As our teams uncover new bacteria that are therapeutically relevant, and unpick the mechanism of action or develop novel production techniques, the intellectual property estate will continue to grow in size and value.
Having secured a class leading patent position, our research teams are able to lead the debate on the role of the microbiome and development of Live Biotherapeutics.
Over the last six months the research teams have presented at key microbiome conferences and published papers on some of their findings with immediate relevance to our clinical programmes, such as the potential of the microbiome to serve as novel therapeutic inhibitors of the human enzyme histone deacetylase ("HDAC"), which could lead to new programmes in cancer or neurodegeneration. As we continue our world-leading research, and build our patent portfolio, we will continue to publish and discuss our work.
Conclusion
At 4D pharma we face the challenge of bringing a new blockbuster drug, in a new therapeutic class, to transform patient lives.
We can only continue to meet this challenge if we focus on the core principles of developing science and delivering therapies.
David Norwood
Non-Executive Chairman
Duncan Peyton
Chief Executive Officer
27 September 2018
Group Statement of Total Comprehensive Income
For the six months to 30 June 2018
Unaudited Unaudited six months six months Audited ended ended year to 30 June 30 June 31 December 2018 2017 2017 Notes GBP000 GBP000 GBP000 ------------------------------------------------- ----------- ----------- ------------ Research and development costs (11,829) (8,305) (16,911) Administrative expenses (1,969) (1,047) (3,529) Foreign currency gains/(losses) 605 (439) (431) ------------------------------------------------- ----------- ----------- ------------ Operating loss before non-recurring cost (13,193) (9,791) (20,871) Non-recurring costs - (3,474) (3,474) ------------------------------------------------- ----------- ----------- ------------ Operating loss after non-recurring cost (13,193) (13,265) (24,345) Finance income 190 287 482 Finance expense (167) (17) (123) ------------------------------------------------- ----------- ----------- ------------ Loss before taxation (13,170) (12,995) (23,986) Taxation 3 2,520 1,179 3,541 ------------------------------------------------ ----------- ----------- ------------ Loss for the year (10,650) (11,816) (20,445) Other comprehensive income Exchange differences on translating foreign operations (652) 566 1,057 ------------------------------------------------- ----------- ----------- ------------ Loss for the year and total comprehensive income for the year (11,302) (11,250) (19,388) ------------------------------------------------- ----------- ----------- ------------ Loss per share Basic and diluted for the year 4 (16.26)p (18.22)p (31.41)p ------------------------------------------------ ----------- ----------- ------------
Group Statement of Financial Position
At 30 June 2018
At At At 30 June 30 June 31 December 2018 2017 2017 Notes GBP000 GBP000 GBP000 ---------------------------------------------- -------- -------- ------------ Assets Non-current assets Property, plant and equipment 5,001 4,782 5,211 Intangible assets 14,515 14,604 14,674 Taxation receivables 84 23 56 ---------------------------------------------- -------- -------- ------------ 19,600 19,409 19,941 ---------------------------------------------- -------- -------- ------------ Current assets Inventories 262 194 253 Trade and other receivables 2,193 2,813 3,238 Taxation receivables 6,442 3,892 4,308 Short-term investments and cash on deposit 15,151 10,000 38,133 Cash and cash equivalents 21,405 49,772 11,865 ---------------------------------------------- -------- -------- ------------ 45,453 66,671 57,797 ---------------------------------------------- -------- -------- ------------ Total assets 65,053 86,080 77,738 ---------------------------------------------- -------- -------- ------------ Liabilities Current liabilities Trade and other payables 3,251 7,899 4,982 ---------------------------------------------- -------- -------- ------------ 3,251 7,899 4,982 ---------------------------------------------- -------- -------- ------------ Non-current liabilities Deferred tax 965 963 965 Other payables 5 2,165 1,875 2,005 ------------------------------------- ------- -------- -------- 3,130 2,838 2,970 ---------------------------------------------- -------- -------- ------------ Total liabilities 6,381 10,737 7,952 ---------------------------------------------- -------- -------- ------------ Net assets 58,672 75,343 69,786 ---------------------------------------------- -------- -------- ------------ Capital and reserves Share capital 164 162 164 Share premium account 108,296 105,909 108,296 Merger reserve 958 958 958 Translation reserve 16 177 668 Other reserve (864) (864) (864) Share-based payments reserve 628 248 440 Retained earnings (50,526) (31,247) (39,876) ---------------------------------------------- -------- -------- ------------ Total equity 58,672 75,343 69,786 ---------------------------------------------- -------- -------- ------------
Approved by the Board and authorised for issue on 27 September 2018.
Duncan Peyton
Director
27 September 2018
Group Statement of Changes in Equity
For the six months to 30 June 2018
Share- based Share Share Merger Translation Other payment Retained capital premium reserve reserve reserve reserve earnings Total GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 --------------------------------------- -------- -------- ----------- -------- -------- --------- -------- At 1 January 2017 162 105,909 958 (389) (864) 138 (19,431) 86,483 Loss and total comprehensive income for the period - - - - - - (11,816) (11,816) Foreign currency gains/losses arising on consolidation of subsidiaries - - - 566 - - - 566 Issue of share-based compensation - - - - - 110 - 110 ---------------------------------- --- -------- -------- ----------- -------- -------- --------- -------- At 30 June 2017 162 105,909 958 177 (864) 248 (31,247) 75,343 Issue of share capital (net of expenses) 2 2,387 - - - - - 2,389 ---------------------------------- --- -------- -------- ----------- -------- -------- --------- -------- Total transactions with owners recognised in equity for the year 2 2,387 - - - - - 2,389 ---------------------------------- --- -------- -------- ----------- -------- -------- --------- -------- Loss and total comprehensive income for the period - - - - - - (8,629) (8,629) Foreign currency gains/losses arising on consolidation of subsidiaries - - - 491 - - - 491 Issue of share-based compensation - - - - - 192 - 192 ---------------------------------- --- -------- -------- ----------- -------- -------- --------- -------- At 31 December 2017 164 108,296 958 668 (864) 440 (39,876) 69,786 Loss and total comprehensive income for the period - - - - - - (10,650) (10,650) Foreign currency gains/losses arising on consolidation of subsidiaries - - - (652) - - - (652) Issue of share-based compensation - - - - - 188 - 188 ---------------------------------- --- -------- -------- ----------- -------- -------- --------- -------- At 30 June 2018 164 108,296 958 16 (864) 628 (50,526) 58,672 ---------------------------------- --- -------- -------- ----------- -------- -------- --------- --------
Group Cash Flow Statement
For the six months to 30 June 2018
Unaudited Unaudited six months six months Audited ended ended year to 30 June 30 June 31 December 2018 2017 2017 GBP000 GBP000 GBP000 --------------------------------------------------- ----------- ----------- ------------ Loss after taxation (10,650) (11,816) (20,445) Adjustments for: Depreciation of property, plant and equipment 443 324 730 Amortisation of intangible assets 148 117 252 Loss on disposal of property, plant and equipment - 78 79 Finance income (190) (287) (482) Finance expense 167 17 123 Non-recurring contingent consideration - 3,474 3,474 Share-based compensation 188 110 302 --------------------------------------------------- ----------- ----------- ------------ Cash flows from operations before movements in working capital (9,894) (7,983) (15,967) Changes in working capital: (Increase)/decrease in inventories (9) 44 (15) Decrease/(increase) in trade and other receivables 393 (23) (588) Increase in taxation receivables (2,164) (578) (1,009) (Decrease)/increase in trade and other payables (1,614) 519 389 --------------------------------------------------- ----------- ----------- ------------ Cash outflow from operating activities (13,288) (8,021) (17,190) --------------------------------------------------- ----------- ----------- ------------ Cash flows from investing activities Purchases of property, plant and equipment (259) (1,078) (1,885) Purchase of software and other intangibles (4) (43) (194) Interest received 115 147 509 Monies placed on/(drawn from) deposit 22,982 30,111 1,978 --------------------------------------------------- ----------- ----------- ------------ Net cash outflow from investing activities 22,834 29,137 408 --------------------------------------------------- ----------- ----------- ------------ Cash flows from financing activities Hire purchase payments (6) (5) (14) --------------------------------------------------- ----------- ----------- ------------ Net cash inflow from financing activities (6) (5) (14) --------------------------------------------------- ----------- ----------- ------------ Increase/(decrease) in cash and cash equivalents 9,540 21,111 (16,796) Cash and cash equivalents at the start of the year 11,865 28,661 28,661 --------------------------------------------------- ----------- ----------- ------------ Cash and cash equivalents at the end of the year 21,405 49,772 11,865 --------------------------------------------------- ----------- ----------- ------------
Notes to the Interim Financial Report
For the six months ended 30 June 2018
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 2018. 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 (GBP'000).
The financial information for the six months ended 30 June 2018 and 30 June 2017 is unaudited.
Full audited financial statements of the Group in respect of the period ended 31 December 2017, which received an unqualified audit opinion and did not contain a statement under section 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 2018 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 2018.
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 at the start-up stage of its business lifecycle. Accordingly they have continued to adopt the going concern basis in preparing the financial information.
3. Taxation
The tax credit is made up as follows:
Unaudited Unaudited six months six months Audited ended ended year to 30 June 30 June 31 December 2018 2017 2017 GBP000 GBP000 GBP000 ----------------------------------------------- ----------- ----------- ------------ Current income tax Total current income tax 2,520 1,169 3,557 Adjustment in respect of prior years - 10 (16) ----------------------------------------------- ----------- ----------- ------------ Total income tax credit recognised in the year 2,520 1,179 3,541 ----------------------------------------------- ----------- ----------- ------------
4. Loss per share
(a) Basic and diluted
Unaudited Unaudited six months six months Audited ended ended year to 30 June 30 June 31 December 2018 2017 2017 GBP000 GBP000 GBP000 ------------------------------------------------------ ----------- ----------- ------------ Loss for the year attributable to equity shareholders (10,650) (11,816) (20,445) ------------------------------------------------------ ----------- ----------- ------------ Weighted average number of shares: Ordinary shares in issue 65,493,842 64,858,150 65,084,561 ------------------------------------------------------ ----------- ----------- ------------ Basic loss per share (pence) (16.26)p (18.22)p (31.41)p ------------------------------------------------------ ----------- ----------- ------------
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:
Unaudited Unaudited six months six months Audited ended ended year to 30 June 30 June 31 December 2018 2017 2017 GBP000 GBP000 GBP000 -------------------------------------- ----------- ----------- ------------ Reported loss after tax (10,650) (11,816) (20,445) Non-recurring costs - 3,474 3,474 -------------------------------------- ----------- ----------- ------------ Adjusted loss after tax (10,650) (8,342) (16,971) -------------------------------------- ----------- ----------- ------------ Adjusted basic loss per share (pence) (16.26)p (12.86)p (26.08)p -------------------------------------- ----------- ----------- ------------
5. Other payables
Unaudited Unaudited six months six months Audited ended ended year to 30 June 30 June 31 December 2018 2017 2017 GBP000 GBP000 GBP000 --------------------------------------------- ----------- ----------- ------------ Non-current payables Contingent consideration (see below and note 6) 2,144 1,875 1,979 Hire purchase and finance leases 21 - 26 --------------------------------------------- ----------- ----------- ------------ 2,165 1,875 2,005 --------------------------------------------- ----------- ----------- ------------
Contingent consideration
The non-current contingent consideration is made up as follows:
Unaudited Unaudited six months six months Audited ended ended year to 30 June 30 June 31 December 2018 2017 2017 GBP000 GBP000 GBP000 -------------------------------------------- ----------- ----------- ------------ Brought forward 1,979 774 774 Reassessment of contingent consideration to be satisfied in shares - 4,395 4,395 Discounting of estimated future cash flows - (921) (921) Part settlement of contingent consideration in shares - - (2,389) Unwinding of discount 165 16 120 -------------------------------------------- ----------- ----------- ------------ 2,144 4,264 1,979 -------------------------------------------- ----------- ----------- ------------ Analysed as follows: Within one year - 2,389 - More than one year 2,144 1,875 1,979 -------------------------------------------- ----------- ----------- ------------ 2,144 4,264 1,979 -------------------------------------------- ----------- ----------- ------------
6. Contingent consideration
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 EUR2.6 million (at GBP3.7575 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.
This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
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