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/

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.

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Appointment of IR Adviser
RNS
RNS Number : 8020X
Motif Bio PLC
02 September 2015



2 September 2015



Motif Bio plc

("Motif" or the "Company")

Motif Appoints Westwicke Partners as Investor Relations Adviser in U.S.



Motif Bio plc (LSE: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announced today that it has appointed Westwicke Partners as its investor relations adviser in the U.S. Westwicke Partners provides strategic investor relations and capital markets advisory services exclusively to public and private companies in the healthcare sector.

Graham Lumsden, CEO of Motif, said: "We look forward to building a relationship with the Westwicke team and to leveraging their experience as we continue to move our clinical development programs forward".

FDA Grants Fast Track Designation for Iclaprim
RNS
RNS Number : 9151X
Motif Bio PLC
03 September 2015

3 September 2015



Motif Bio plc

("Motif" or the "Company")

FDA Grants Fast Track Designation for Iclaprim



Motif Bio plc (AIM: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for iclaprim intravenous (IV) to treat Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Hospital Acquired Bacterial Pneumonia (HABP).

The FDA's Fast Track programme is designed to aid the development and accelerate the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Drugs with Fast Track designation typically qualify for priority review, which expedites the FDA review process and market approval. Companies that receive Fast Track designation for a drug benefit from more frequent interactions with the FDA during clinical development and can submit completed sections of their New Drug Application (NDA) on a rolling basis.

Graham Lumsden, Chief Executive Officer at Motif, said: "This is excellent news for Motif and comes on the back of the QIDP designation for iclaprim in late July. This Fast Track designation means we will benefit from greater FDA support and that we remain on our Phase III development timeline. "

The FDA has previously designated iclaprim for the treatment of ABSSSI and HABP as a Qualified Infectious Disease Product (QIDP). The QIDP designation will make iclaprim eligible to benefit from certain incentives as provided under the Generating Antibiotic Incentives Now (GAIN) Act. These incentives include FDA priority review, eligibility for fast-track status, and if ultimately approved by the FDA, iclaprim would 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.

Shares - Motif Bio the best IPO of 2015 up 168% since admission 7 Apr 15

Results of Two Posters on Iclaprim at ID Week 2015
RNS
RNS Number : 0311C
Motif Bio PLC
13 October 2015

13 October 2015



Motif Bio plc

("Motif" or the "Company")

Announces Results of Two Posters on Iclaprim at ID Week 2015

Motif Bio plc (AIM: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, today announced results of two iclaprim clinical studies that were presented at the Infectious Disease Week 2015 (ID Week) conference in San Diego, California on 9 October, 2015. Iclaprim is a novel antibiotic, targeting the bacterial dihydrofolate reductase enzyme, which is currently starting two Phase III clinical trials to treat acute bacterial skin and skin structure infections (ABSSSI).

Dr. David Huang, Chief Medical Officer at Motif, commented: "Data from these studies provides us with further confidence that iclaprim can perform well in the two Phase III trials in ABSSSI. Furthermore, the Phase II data in nosocomial pneumonia caused by Gram-positive bacteria, which are commonly identified as Staphylococcus aureus, including MRSA, provides good evidence that iclaprim may also be successful in our planned Phase III clinical trials to treat hospital-acquired and ventilator-associated bacterial pneumonia."

The two posters:

(1) "Cessation of Spread of Lesion and Absence of Fever at 72 hours in Complicated Skin and Skin Structure Infection (cSSSI): Reanalysis of the Combined ASSIST Phase III Study Comparing Iclaprim and Linezolid."

This poster presented data on the reanalysis of two Phase III studies to treat cSSSI comparing iclaprim to linezolid, a standard of care treatment for SSSI, using endpoints similar to those based on the US Food and Drug Administration's (FDA) recently changed guidelines for ABSSSI trials.

In the first Phase III study, patients who received iclaprim and linezolid had an early clinical response, defined as cessation of lesion spread and fever resolution at 72 hours of 73.9% and 71.4%, respectively: difference 2.5%; 95% confidence interval -5.6% to 10.6%.

In the second Phase III study, patients treated under the same treatment regimen had an early clinical response of 73.3% and 73.7%, respectively: difference -0.4%; 95% confidence interval -8.4% to 7.7%.

These data show that iclaprim achieved a high rate of early clinical response among patients with cSSSI.



(2) "Randomized, Double-Blind, Multicenter Phase II Study to Evaluate Efficacy and Safety of Intravenous Iclaprim versus Vancomycin in the Treatment of Hospital-Acquired, Ventilator-Associated, or Health-Care-Associated Pneumonia Suspected or Confirmed Caused by Gram-positive Pathogens."

This poster presented data on outcomes related to treatment with iclaprim compared to vancomycin, a standard of care treatment for Hospital-acquired bacterial pneumonia (HABP), ventilator-associated pneumonia (VAP) and healthcare-associated pneumonia (HCAP).

Patients who received a low dose of iclaprim, a high dose of iclaprim, and vancomycin had a clinical cure rate of 73.9%, 62.5%, and 52.2%, respectively. Under the same treatment regime patients had a Day 28 mortality rate of 8.7%, 12.5%, and 21.7%, respectively.

These data show that iclaprim had high clinical cure rates and relatively low mortality rates among patients with HABP, VAP, and HCAP.

Leading CRO to Conduct Iclaprim Phase III Trials
RNS
RNS Number : 4594C
Motif Bio PLC
16 October 2015

16 October 2015



Motif Bio plc

("Motif" or the "Company")

Contract Signed With Leading CRO to Conduct Iclaprim Phase III Clinical Trials



Motif Bio plc (AIM: MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, today announced the signing of a clinical trials agreement with Covance, a leading global Contract Research Organisation (CRO), and a wholly owned subsidiary of Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH). The trials under the agreement are for iclaprim, a targeted spectrum antibiotic designed to be effective against multi-drug-resistant bacteria, including MRSA.

Covance will run two Phase III randomised, double blind, multicentre clinical trials with iclaprim. The trials will evaluate the efficacy and safety of intravenous iclaprim versus intravenous vancomycin in the treatment of acute bacterial skin and skin structure infections (ABSSSI). In addition to Covance's considerable experience running antibiotic trials, a key consideration for Motif in selecting Covance as its development partner, was the ability to leverage LabCorp's powerful patient data for these trials.

David Huang, Chief Medical Officer at Motif, said: "The signing of this agreement with Covance is a great step forward for Motif and its development strategy for iclaprim, and ensures a timely start of the Phase III programme. We are now progressing with the selection of countries and investigator sites; programme study drug logistics; and submission of regulatory documents to health authorities, institutional review boards, and independent ethics committees worldwide. Motif remains firmly on track to meet its goal of marketing iclaprim in 2018."

Who Should Attend?Date:

Wednesday 4th November 2015

Venue:

Novotel Tower Bridge, London EC3N, 10 Pepys Street, London, EC3N 2NR

Event Timings:Sponsored by:

European Agreement for Iclaprim Development
RNS
RNS Number : 2712F
Motif Bio PLC
11 November 2015

11 November 2015



Motif Bio plc

("Motif" or the "Company")



European Agreement for Iclaprim Phase III Clinical Development Programme



Motif Bio plc (AIM:MTFB), the clinical stage biopharmaceutical company specialising in developing novel antibiotics, announced today that it has received written advice from a Scientific Advice Meeting with the Medicines Evaluation Board (MEB) in Utrecht, The Netherlands, held on 16 September 2015, in relation to the Phase III Clinical Development Programme for iclaprim.

The MEB's advice confirms that two Phase III clinical trials plus microbiological data derived from the planned surveillance studies, are acceptable as pivotal registration studies for approval in the European Union through the "centralized" regulatory procedure of intravenous iclaprim, a targeted spectrum antibiotic designed to be effective against multi-drug-resistant bacteria, including MRSA.



Dr. David Huang, Chief Medical Officer at Motif, said: "With MEB acceptance of our proposal for two Phase III clinical trials for iclaprim, Motif remains firmly on track to meet its goal of completing the two ABSSSI trials in 2017, and submitting a Marketing Authorisation Approval in Europe

Proactive investors -

Broker upgrade for Motif Bio with NASDAQ listing ahead


15:35 27 Jul 2016

Analysts at Northlands Capital said there was a “chronic under-investment” in antibiotic resistance.

Resistant bacterium

Anti-biotic resistance is a major health concern for medical bodies across the world.


Anti-biotic resistance is a major health concern for medical bodies across the world and one that needs to be addressed fast.

The world could face 10mln lives lost every year and up to US$100trn in lost productivity by 2050, according to experts.

An estimated 50,000 deaths already occur annually across Europe and the US due to antibiotic resistance.

Currently listed on London’s junior market AIM, the biotech group Motif Bio Plc (LON:MTFB) is developing new types of anti-biotics to combat resistance.

The development of novel antibiotics is an important part of the solution to this looming crisis.

In preparation for its up-coming US drug launch, earlier this month Motif Bio said it planned to list on NASDAQ.

Analysts at Northlands Capital said there was a “chronic under-investment” in the area by the pharmaceutical industry, but that means big potential for Motif.

The broker said that a US listing could help bridge the significant valuation gap between Motif and its US peers.

Other companies operating in the same field in the US include Cempra (NASDAQ:CEMP) and Paratek (NASDAQ:PRTK), both listed on NASDAQ, are valued significantly more than Motif.

“We believe that the discrepancy in pricing between the group and its US-peers would be thrown into sharp relief,” said the analysts.

Motif already has all-important FDA consent to conduct Phase 3 clinical trials for iclaprim in two requested indications, Acute Bacterial Skin and Skin Structure Infections and Hospital Acquired Bacterial Pneumonia.

Northland estimates sales of the treatments could easily reach billions of dollars a year once it reaches the commercial market.

Through the listing, Motif expects to raise up to US$60mln selling around 100mln shares.

With the potential of the drug in the US and the up-coming listing, Northlands Capital has raised its target price from 114p to 140p, indicating a significant potential upside of 200% on the current price of 48p per share.

Can Motif Bio really surge 400%? - By David Brenchley | Wed, 5th April 2017 - 13:14

When was the last time you were told there was an investment that could make five times your money? Well, broker finnCap thinks Motif Bio (MTFB), the company behind a late-stage antibiotic called iclaprim, could do the job.

Initiating coverage of the AIM-listed shares, analyst Alex Pye thinks they could be worth 125p. After funding concerns last autumn dumped the shares from 53p to 21p – just a penny above the 2015 IPO price of 20p - that bullish target implies potential upside of a colossal 400%.

However, don't put that deposit down on the new Ferrari just yet! Pye's objective is the product of a 13-year view, reflecting a net present value of £245 million using a risk-adjusted discounted cash flow model.

So, it could be a long road, and there's a bucketload of risk here, but there are also plenty of potential catalyst events to get the shares shifting in the right direction. And finnCap believes a re-rating, at least, could begin soon.



Watch for a positive phase III REVIVE data readout in the second quarter of 2017, says Pye. This is the clinical trial investigating the safety and efficacy of iclaprim to treat patients with Acquired Bacterial Skin and Skin Structures Infection (ABSSSI).

He points out that shares in Nasdaq–listed Achaogen more than tripled overnight last December following positive phase III results for its gram-negative candidate plazomicin, another drug which attacks super bugs.

But Motif Bio is short of cash and needs another $10 million to complete its second phase III trial, REVIVE-2. FinnCap believes that a positive REVIVE-1 readout should attract potential backers and make an equity fundraising much easier.

"Motif worked closely with the US Food and Drug Administration (FDA) in designing these pivotal trials and if primary endpoints are reached successfully, we expect the shares to be re-rated," writes Pye.

There could also be upside if Motif Bio agrees a partnering licence agreement with a "notable and respected pharmaceutical company for upfront payments and reduced development costs", Pye says. Grant funding from numerous possible sources would be a further catalyst.

Comparable antimicrobials have already gained approval, he explains: "Daptomycin [achieved] more than $1 billion global sales, all with similar clinical trial designs."

Motif Bio shares are already inching higher as finnCap's argument is very persuasive, but small biotechs like this are incredibly high risk.

Confidence took a huge hit late last year funding issues arose and, although money was forthcoming, the company needs more, potentially up to $42 million to complete Phase III trials in Hospital-Acquired Bacterial Pneumonia (HABP) for iclaprim. Thankfully, REVIVE-1 results are expected before net cash falls below zero.

There's also a chance that these results will be disappointing. But here, too, Pye thinks risk is mitigated by the "overwhelmingly positive" historical Phase II and III data that support the safety and efficacy of iclaprim.

As we wrote in June 2015, one to watch.

Is this massive fall ( 40p to abt 7p, mid-Feb 2019 ), only due to repaying a large loan? Surely Motif knew it would become due.... and where will the money come from... is this asking Shareholders for cash likely - about that 7p point?
How is the Bio-part going? I see no mention of any "Failure" but wonder why the sp rose from 25p last Dec.up to 40p - this is usually in anticipation of Trial-Success. Must presume "Fall" is the likelyhood of a cash-call. . . . . Anyone?