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.
- 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.
- 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.”
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.”
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.
Richard C.E. Morgan
27 August 2015
Motif Bio plc
Graham Lumsden, Chief Executive Officer
Robert Bertoldi, Chief Financial Officer
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Notes to Editors
Motif is a clinical stage biopharmaceutical company, which specialises in developing novel antibiotics designed to be effective against serious and life-threatening infections caused by multi-drug resistant bacteria.
Iclaprim is being developed for the treatment of the most common and serious bacterial infections such as acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), including those caused by resistant strains such as MRSA (methicillin-resistant Staphylococcus aureus) and MDRSP (multi-drug resistant Streptococcus pneumoniae) that have become prevalent in patients in both the community and hospital settings.
The Company is in discussions with pharmaceutical companies and universities to build a pipeline of innovative antibiotics targeting Gram-positive and Gram-negative bacteria.