Motif is developing novel antibiotics designed to be effective against serious and life-threatening infections caused by multi-drug resistant bacteria. Motif has a lead antibiotic candidate, iclaprim, and MTF-001, a preclinical program to design a best-in-class dihydrofolate reductase inhibitor (DHFRi). Discussions and negotiations with academic institutes are under way to build a portfolio of antibiotic candidates through licensing. It is anticipated that Motif’s lead antibiotic candidate could be ready for commercialization as early as 2018.

At Motif, members of our team have already developed blockbuster new drugs at the world’s leading pharmaceutical companies and are the named inventors on over 160 U.S.‐issued patents. With our deep drug discovery and development expertise, we have unique proprietary insights to fix flaws of existing first‐in‐class drugs and to design best‐in‐class compounds. We have partnered with leading drug discovery and development companies. Together with a seasoned management team, Motif is positioned to rapidly identify and commercialize novel antibiotics.

Antibiotic resistance has limited the effectiveness of many existing drugs. The discovery of new antibiotics to address this resistance has not kept pace with the increasing incidence of difficult‐to‐treat bacteria. Without new antibiotics effective against resistant bacteria, the risk is that within five to ten years, routine surgeries such as hip and knee replacements, cardiac catheterization, caesarian section, and coronary artery bypass grafts would be impossible without effective antibiotics. One of the biggest threats is from methicillin‐resistant staphylococcus aureus (“MRSA”), a leading cause of hospital‐acquired infections and a growing cause of infections in healthy people. In 2013, the Centers of Disease Control (“CDC”) reported that at least 2M people became infected with bacteria that are resistant to antibiotics and at least 23,000 Americans died as a direct result of these infections – more than the annual number of deaths of people diagnosed with AIDS.

Given the urgent need to find new antibiotics to address this problem, Motif has a dedicated effort in developing new best‐in‐class antibiotics, each targeting different and unique mechanisms of action to be effective against bacteria that are resistant to most currently available antibiotics.


First Day of Dealings: Clinical stage biopharmaceutical company developing new antibiotics admitted to AIM April 2, 2015



http://www.motifbio.com/

RNS out.

Motif partners with Leading Global CRO
RNS
RNS Number : 7104O
Motif Bio PLC
01 June 2015

1 June 2015

Motif Bio Plc

("Motif" or the "Company")

Motif partners with Leading Global CRO for Phase III Clinical Trials with Iclaprim

Motif Bio plc (LSE: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announced today that its wholly-owned subsidiary, Motif BioSciences Inc., has signed Letters of Intent (LOIs) and interim agreements with a leading global Clinical Research Organisation (CRO). Under the terms of these interim agreements, the CRO will undertake preparations for two Phase III, randomised, double-blind, multicenter clinical trials to evaluate the efficacy and safety of intravenous iclaprim versus vancomycin in the treatment of acute bacterial skin and skin structure infections ("ABSSSIs") suspected or confirmed to be due to Gram-positive pathogens.

Iclaprim is a broad-spectrum antibiotic designed to be effective against multi-drug resistant bacteria. Motif is investing over US$950,000 under the terms of the interim agreements, to be paid by 31 July 2015. Pursuant to the LOIs, the parties will negotiate the terms and conditions of a mutually acceptable formal agreement for the conduct of the two studies.



The selected CRO is one of the world's top five providers of Phase I-IV clinical trial management services and to date, has contributed to the development of all of the top 50 prescription medicines on the market. The CRO has unique insights into infectious disease clinical trials with over 17,000 patients in more than 150 studies.



Graham Lumsden, CEO of Motif Bio plc, commented:

"Retaining this leading global CRO is the first major step for Motif in achieving our goal of successfully completing Phase III clinical trials with iclaprim. The safety and efficacy of this broad spectrum antibiotic has already been proven in many patients, and we believe that iclaprim may be an important treatment option for ABSSSIs. Combining the knowledge and experience of Motif's management and directors with the infectious diseases expertise of our selected CRO is expected to add tremendous value for our investors."

1 Jun Northland... 89.00 Buy

Up 15% today.

A further 22% today

RNS
RNS Number : 5772P
Motif Bio PLC
09 June 2015

9 June 2015

Motif Bio plc



Motif BioSciences, Inc.

Audited non-statutory financial statements for the

year ended 31 December 2014



Motif Bio plc (LSE: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, reports to the market today the non-statutory financial statements of its wholly-owned subsidiary, Motif BioSciences, Inc. for the year ended 31 December 2014 - a period prior to the completion of the Company's merger, acquisition, and admission to AIM.



Since the end of the period covered by these financial statements, Motif Bio plc has completed the Group re-organisation, a necessity of becoming the holding company of the Group. Motif has also converted and restructured its liabilities, acquired the iclaprim assets, and raised new funds of approximately US $4.3 million, before issue costs of approximately US $1.0 million, through a placing and subscription of new shares and seen its shares admitted to trading on AIM.

These financial statements have been published to enable Motif Bio plc to comply with its financial reporting obligations under the AIM Rules and are presented and prepared in a form consistent with the financial information, and on the basis of the accounting policies of Motif BioSciences, Inc. set out in Part IV of the AIM admission document published by Motif Bio plc on 27 March 2015.

POST BALANCE SHEET HIGHLIGHTS:



· A transformational period including completion of the Group's re-organisation, acquisition of iclaprim's assets, US $4.3 million raised in new funds and successful listing on AIM.



· On 15 April 2015, the U.S. Food and Drug Administration (FDA) agreed to the proposed Phase III clinical development programme for iclaprim.



· On 1 June 2015, Motif BioSciences, Inc. signed Letters of Intent and interim agreements with a leading global Clinical Research Organisation - one of the world's top five providers of Phase I-IV clinical trial management services and to date, has contributed to the development of all of the top 50 prescription medicines on the market.



· Motif Bio plc selected to present at the 2015 BIO Equity Conference and at the 2015 BIO International Convention, two leading global partnering and investor events for the Biotechnology sector.



· One of the few opportunities for AIM investors to gain exposure to a late stage clinical asset that already has a wealth of safety and efficacy data from previously completed Phase III trials.



Richard Morgan, Chairman of Motif Bio plc, commented:



"Motif Bio plc has made excellent progress in a short period of time towards the goal of completing the clinical development of iclaprim and bringing this novel antibiotic to market. It is unusual to have a late stage clinical asset that already has a wealth of safety and efficacy data from previously completed Phase III trials, and that now has agreement from the FDA to initiate a new Phase III programme. The scientists at Motif Bio plc have been able to identify a number of ways to improve this new Phase III programme, based on careful analysis of the existing data, the evolving knowledge of infectious diseases, and the improved regulatory environment.



"With new incentives from governments, including the GAIN Act in the US, broad recognition by politicians and regulators of the need to help speed the development of novel antibiotics, and the unique properties of iclaprim, Motif Bio plc is well placed to make an important contribution in response to the challenges of anti-microbial resistance and the need for novel antibiotics."

9 Jun Northland... 89.00 Buy

10 Jun Beaufort... 110.00 Speculative Buy

On Wednesday, Motif Bio PLC (MTFB:LSE) closed at 70.00, 8.9 % below its 52-week high of 76.83, set on Jun 04, 2015.

24 Jun Beaufort... 110.00 Speculative Buy

New Addition to Scientific Advisory Board
RNS
RNS Number : 0497T
Motif Bio PLC
15 July 2015

15 July 2015

Motif Bio plc

("Motif" or the "Company")



Motif Bio Appoints Dr. Thomas M. File to its Scientific Advisory Board

Motif Bio plc (LSE: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, today announced the appointment of Dr. Thomas M. File to its Scientific Advisory Board. Currently, Dr. File, a renowned expert in infectious diseases, Chairs the Division of Infectious Diseases at Summa Health System, Akron, Ohio, is Professor of Internal Medicine and Master Teacher, and the Chair of the Infectious Disease Section of Northeast Ohio Medical University (NEOMED).

Dr. File is a highly respected and internationally recognized expert on infectious diseases including skin and skin structure infections (SSSIs) and pneumonia. Previously, Dr. File served as Past-President and as a member of the Board of Directors for the National Foundation for Infectious Diseases and on the Board of Directors for the Infectious Disease Society of America. In 2010, he was elected as a Faculty Member to the Alpha Omega Alpha Honorary Society and in 2013, was recipient of the Watanakunakorn Clinician Award of the Infectious Diseases Society of America.

Over the last 38 years, Dr. File has published over 275 original papers and numerous review articles and delivered some 145 presentations on various aspects of infectious diseases at scientific meetings throughout the USA and internationally. He currently, serves on the Editorial Boards of Infectious Diseases in Clinical Practice, where he is Editor-in-Chief; Infectious Disease News; plus the Journal of Microbiology and Immunology and Infection.

Dr. David Huang, Chief Medical Officer at Motif Bio plc, commented: "We are very pleased to welcome Dr. Tom File to our team of scientific experts. Dr. File's extensive clinical and research knowledge in infectious diseases, especially in the management and treatment of SSSIs and pneumonia, will provide critical expert input into the clinical development of our anti-bacterial programmes for serious and life threatening conditions."

15 Jul Northland... 89.00 Buy

FDA QIDP Designation for Iclaprim for HABP
RNS
RNS Number : 3158T
Motif Bio PLC
17 July 2015

17 July 2015

Motif Bio plc.

("Motif" or the "Company")

FDA QIDP Designation for Motif's Lead Antibiotic Candidate Iclaprim for HABP



Motif Bio plc. (LSE: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announces that the U.S. Food & Drug Administration (FDA) has designated iclaprim, a broad-spectrum antibiotic designed to be effective against multi-drug resistant bacteria, as a Qualified Infectious Diseases Product (QIDP) for hospital acquired bacterial pneumonia (HABP)

The Company requested QIDP designation for Iclaprim for two serious and life threatening infections, HABP and acute bacterial skin and skin structure infections (ABSSSI). QIDP designation has been confirmed for HABP and an additional administrative step has been requested by FDA in order to confirm QIDP designation also for ABSSSI. Motif has already complied with the requested additional administrative step and is awaiting confirmation from FDA, expected within the next few days.

The Directors, having consulted with the Company's regulatory and legal advisers, are confident that QIDP designation for ABSSSI will be granted

QIDP designation, provided under the Generating Antibiotic Incentives Now Act (GAIN Act), makes iclaprim eligible for certain incentives, including priority review and fast track designation. If ultimately approved by the FDA, iclaprim will be eligible for an additional five-year extension of Hatch-Waxman exclusivity, for a total of 10 years of market exclusivity, starting from the date of NDA approval.

On 23 June 2015, the Company announced a £22 million placing conditional upon the Company receiving the grant of QIDP status for iclaprim not later than 24 July 2015 and upon shareholders approving the resolution at the General Meeting on 10 July 2015. The shareholder resolutions were approved at the General Meeting.

The Company looks forward to updating the market shortly.

17 Jul Northland... 89.00 Buy

Final condition of �22m placing satisfied
RNS
RNS Number : 7048T
Motif Bio PLC
22 July 2015

22 July 2015

Motif Bio plc

("Motif" or the "Company")

Final condition of £22 million placing satisfied with FDA QIDP Designation for iclaprim



Motif Bio plc (LSE: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announces that further to the Company's announcement on Friday 17 July 2015, the US Food & Drug Administration ("FDA") has designated iclaprim, a broad-spectrum antibiotic designed to be effective against multi-drug resistant bacteria, as a Qualified Infectious Diseases Product ("QIDP") for hospital acquired bacterial pneumonia ("HABP"), the final condition of the £22 million placing which was announced on 23 June 2015 has been satisfied. The satisfaction of the other condition, the shareholders approving resolutions related to the placing at a General Meeting, was announced by the Company on 10 July 2015.

The Company expects that admission and dealings in the 44,000,000 placing shares (the "Placing Shares") will commence on 27 July 2015.

As previously announced, the Company requested QIDP designation for iclaprim for two serious and life threatening infections, HABP and acute bacterial skin and skin structure infections ("ABSSSI"). QIDP designation has been confirmed for HABP and an additional administrative step has been requested by the FDA in order to confirm QIDP designation for ABSSSI. Motif has already complied with the requested additional administrative step and is awaiting confirmation of the grant of QIDP designation for ABSSSI from the FDA, which is expected shortly.

QIDP designation, provided under the Generating Antibiotic Incentives Now Act ("GAIN Act"), makes iclaprim eligible for certain incentives, including priority review and fast track designation. QIDP designation also means that iclaprim is eligible for an additional five-year extension of Hatch-Waxman exclusivity, giving a total of 10 years of market exclusivity which will run from the date of approval.

Graham Lumsden, CEO of Motif Bio plc said:



"QIDP designation for iclaprim for HABP is an important step in continuing to build the value of iclaprim and is another positive for Motif and our investors. We believe that iclaprim is the first and only dihydrofolate reductase inhibitor to receive QIDP designation.



"Further, we are delighted to have satisfied the final condition of our recently announced placing, and with the support of our investors look forward to commencing the Phase III trials for iclaprim and further advancing the Company's portfolio."








Total Voting Rights

Following admission of the Placing Shares, the total issued share capital of the Company will be 108,346,216 ordinary shares with one voting right each. The Company does not hold any shares in treasury.

Accordingly, the total voting rights in the Company will be 108,346,216. This figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the share capital of the Company under the Disclosure and Transparency Rules of the UK Financial Conduct Authority.

22 Jul Northland... 103.00 Buy

23 Jul Beaufort... 110.00 Speculative Buy
23 Jul Northland... 114.00 Buy
22 Jul Northland... 103.00 Buy

shard-market-eye-motif-bio-all-set-for-the-clinical-trial-programme

Interims Results for the 6 months to 30 June 2015
RNS
RNS Number : 2268X
Motif Bio PLC
27 August 2015

Motif Bio plc

("Motif" or the "Company")



Interims Results for the 6 months to 30 June 2015



27 August 2015 - Motif Bio plc (AIM: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announced today its maiden interim financial results as an AIM-listed Company.



Corporate/operational highlights:



· On 2 April 2015, the Company completed an AIM listing raising £2.8 million at 20 pence per share;



· The U.S. Food and Drug Administration (FDA) agreed to Phase III trials of iclaprim; and



· Motif partnered with a global leading CRO for Phase III clinical trials of iclaprim.



Financial Highlights:



· Cash and cash equivalents as at 30 June 2015 of $2.8 million (31 December 2014: nil)



Since Period End:



· QIDP designation granted by the FDA for iclaprim in ABSSSI and HABP;



· Successful placing on 22 July 2015 raising £22 million at 50 pence per share;



· Independent tests by JMI Laboratories showed iclaprim to be effective in vitro against a range of Gram-positive bacteria and 16 times more potent than trimethoprim; and



· Appointment on 15 July of Dr. Thomas M. File, and the appointments today of Dr. Matthew Dryden, and Dr. Antoni Torres to the Scientific Advisory Board.



Graham Lumsden, CEO of Motif Bio plc said:



"This has been a truly transformational period for Motif. In April, the Company completed its IPO and listing on AIM raising £2.8 million, which was followed by FDA approval to enter Phase III with iclaprim and a further successful share placing in July, which raised £22 million from institutional investors, enabling Motif to proceed with its plans to conduct Phase III trials with iclaprim. Iclaprim is a broad-spectrum antibiotic designed to be effective against multi-drug resistant bacteria.



"Since the period end, Motif has achieved some important milestones. In July, we received QIDP (Qualified Infectious Disease Product) designation for iclaprim for two indications, ABSSSI (Acute Bacterial Skin and Skin Structure Infections) and HABP (Hospital Acquired Bacterial Pneumonia). In addition, as reported on 24 August, JMI Laboratories' independent report showed iclaprim to be effective in vitro against a broad range of Gram-positive bacteria. The results showed iclaprim to be 16 times more potent than trimethoprim, which is the only other antibacterial dihydrofolate reductase inhibitor administered alone in today's market.



"We continue to build value for our shareholders and are making excellent progress with the preparations for commencing the Phase III trials."



Chairman's Statement

I am pleased to report to shareholders today on the Company's maiden interim financial results as an AIM-listed Company, which covers the period of the 6 months to 30 June 2015.



Progress to Date

On 2 April 2015, Motif Bio plc successfully completed its AIM listing raising £2.8 million at 20 pence per share. We were delighted to announce on 23 June 2015, a conditional placing of 44 million new ordinary shares at a placing price of 50 pence per ordinary share with institutional investors to raise £22 million. On 22 July 2015, the FDA designated iclaprim as a Qualified Infectious Diseases Product (QIDP) for hospital acquired bacterial pneumonia (HABP). This satisfied the final condition of the placing, with admission of the 44 million new ordinary shares occurring on 27 July 2015.



Further on 22 July 2015, the Company reported that the FDA had also designated iclaprim as QIDP for acute bacterial skin and skin structure infections (ABSSSI), the second of two serious and life threatening infections for which we applied for QIDP status. With QIDP designation, iclaprim is now eligible for a total of 10 years of market exclusivity, thus making this development an important step in continuing to build the value of iclaprim for Motif and our investors. The Board believes that iclaprim is the first and only dihydrofolate reductase inhibitor to receive QIDP designation. With the support of our investors we look forward to commencing the Phase III trials for iclaprim and further advancing the Company's portfolio.



Most recently, on 24 August 2015, the Company updated shareholders on the results of an independent report from microbiology specialists, JMI Laboratories. The report showed that iclaprim is effective in vitro against a range of Gram-positive bacteria, including Staphylococcus aureus, one of the key causes of ABSSSI and HABP. The recently completed laboratory study tested iclaprim against more than 2,000 bacterial strains, including 1,178 strains of Staphylococcus aureus collected in 2014 from patients in the U.S.A., Europe, Asia Pacific, and Latin America. Iclaprim was found to be 16 times more potent than trimethoprim, the only other antibacterial dihydrofolate reductase inhibitor (DHFRi) administered alone in today's market. The tests were conducted according to Clinical and Laboratory Standards Institute (CLSI) methods. CLSI develops clinical laboratory testing standards based on input from and consensus among industry, government, and health care professionals around the world.



After the reporting period, Motif further strengthened its Scientific Advisory Board with the appointment of three new advisors. As previously reported, Motif appointed Dr. Thomas File, an internationally recognised expert in infectious diseases including skin structure infections (SSSIs) and pneumonia. We are pleased to announce today the additional appointments of Dr. Matthew Dryden and Dr. Antoni Torres. Dr. Dryden is an Infectious Diseases Specialists who serves as the Director of Infection, Hampshire Hospitals, Winchester and University of Southampton, United Kingdom. Dr. Dryden's research interests have been in staphylococcal infection, the development of new antibiotics, the management of MRSA infections, and Lyme disease in the UK. Dr. Torres is a Pulmonologist and he currently serves as the Head of the Respiratory Intensive Care Unit in the Department of Pneumology and Respiratory Allergy, Clinical Institute of the Thorax, Hospital Clinic of Barcelona. He is Professor of Medicine at the University of Barcelona.



Addressing a Global Crisis

Resistance to antibiotics is a major global health threat. So-called "superbugs" are developing resistance to currently available antibiotics faster than new, effective antibiotics are being developed. In June 2013, Dr. Margaret Chan, Director-General of the World Health Organisation stated that, "a post-antibiotic era means, in effect, an end to modern medicine as we know it. Things as common as strep throat or a child's scratched knee could once again kill. Some sophisticated interventions, like hip replacements, organ transplants, cancer chemotherapy, and care of preterm infants, would become far more difficult or even too dangerous to undertake."



Outlook

Iclaprim is being designed to be administered in hospitals as an intravenous infusion. The directors believe the most urgent need for novel antibiotics effective against multi-drug resistant bacteria is in the hospital setting where patients often succumb to serious, life-threatening infections that require immediate treatment with the best available antibiotic. In the case of HABP, mortality rates for infected patients are currently between 20 per cent. and 50 per cent. The directors believe that commercialisation of hospital products can be done with fewer resources than commercialisation in the community because there are fewer hospital healthcare professionals to communicate with, compared to launching and educating the larger number of primary care and general practitioners in most countries.



This has been a truly transformational period for Motif. We continue to build value for our shareholders and are making excellent progress with the preparations for commencing the Phase III trials.

Beaufort -


Motif Bio (LON:MTFB) – Speculative Buy

Half year results released yesterday were largely academic, detailing Total loss for the period of US$1.86m (US$0.55m), while cash and cash equivalents as at 30th June 2015 of US$2.8m (31st December 2014: nil). By comparison, operational highlights for the period were anything but, with the US Food and Drug Administration (FDA) agreed to Phase III trials of iclaprim, while partnering with a global leading CRO for Phase III clinical trials. Since the period end, it has also been granted QIDP designation by the FDA in ABSSSI and HABP, while independent tests by JMI Laboratories demonstrated iclaprim to be effective in vitro against a range of Gram-positive bacteria and 16 times more potent than trimethoprim. A successful placing on 22nd July 2015 raising £22m at 50 pence/share also left the group cash rich ahead of commencing the Phase III trials.

Our view: While the interim results told shareholders little that they did not already know, they do serve as a reminder of exactly why Beaufort is such a supporter of Motif shares. They present shareholders with a genuine ‘bonanza’ opportunity. Management is building exceptional value while making significant progress in preparation for commencing the Phase III trials. Iclaprim is being designed to be administered in hospitals as an intravenous infusion. A most urgent need for novel antibiotics effective against multi-drug resistant bacteria is in the hospital setting where patients often succumb to serious, life-threatening infections that require immediate treatment with the best available antibiotic has clearly been established. In the case of HABP, for example, mortality rates for infected patients are currently between 20% and 50% and, in response, Motif seeks to accelerate its speed to market by targeting commercialisation as a hospital product rather than through the wider medical community. Indeed, given the opportunity already identified in HABP and ABSSSI along with a number of other potential indications, the prospective market value for this novel antibiotic is very large indeed, potentially running in billions of US dollars. The much publicised global need for such new drugs means that iclaprim must already be under review by Big Pharma, with a view to farming-in to Motif’s opportunity in exchange for financing late stage development and subsequent commercialisation. Realistically, such an outcome might be expected before end-2016. The value this will accrue to Motif should then be quite considerable. Beaufort repeats its Speculative Buy rating for Motif Bio and confirms a price target of 110p/share.