MGB Biopharma provides update on business performance for 2014

Highlights

• In September 2014, MGB Biopharma secured £4M ($6.4M) from leading Scottish investors and Innovate UK for further clinical development of lead antibiotic MGB-BP-3
• Significant progress in manufacturing the MGB-BP-3 API - agreements with Almac Group Ltd and Encap Drug Discovery
• Oral formulation of MGB-BP-3 for the treatment of Clostridium difficile infections on track to enter the clinic in Q2 2015
• Novel preclinical I.V. formulation successfully developed for the treatment of hospital-acquired Gram-positive infections and the programme is expected to progress further towards IND-ready stage through 2015
• Internationally renowned medical microbiologist Dr Stephanie Dancer appointed to MGB's Scientific Advisory Board
• MGB Biopharma nominated and shortlisted for Scottish Enterprise Life Sciences Awards 2015

MGB Biopharma, a biopharmaceutical company developing a truly novel class of anti-infectives, provides an update on its business performance for 2014. MGB Biopharma is developing a pipeline of novel antimicrobials that puts it at the forefront of addressing the major global problem of antimicrobial resistance.

"MGB Biopharma has made excellent progress across all areas of the business in 2014," said Dr Miroslav Ravic, MGB Biopharma's CEO. "We secured £4 million, including a £1.3 million funding award from the Biomedical Catalyst programme in September 2014 to advance our novel antibiotic candidate MGB-BP-3. The equity funding, from a syndicate of Scotland's leading investors, clearly highlights their ongoing commitment to our business and to our unique approach to develop differentiated antibacterials. We concluded significant manufacturing agreements with Almac and Encap for the supply of our forthcoming trials with MGB-BP-3. As a result, we remain on track to start Phase I trials with the oral formulation of MGB-BP-3 for C.difficile in the first half of 2015 and expect the preclinical I.V. formulation for hospital-acquired Gram-positive infections to be IND-ready by the end of 2015.

"With our truly novel anti-infective candidates that have a unique mode of action and a broad platform, we are well positioned to address the global call for better anti-infectives that can help solve the major problem of resistance. We believe 2015 will be a pivotal year for the Company and the progress of MGB-BP-3 as we deliver important milestones that will significantly increase the value of our business."

£4 million in funding secured

In September 2014, MGB Biopharma secured £4 million ($6.4M) for the further development of its novel lead antibiotic candidate MGB-BP-3. MGB-BP-3 is being developed against a range of Gram-positive infections including C. difficile (oral) and resistant and susceptible Staphylococcus and Streptococcus species (I.V.). MGB-BP-3 is the first antibacterial for over a decade with a novel mode of action from a truly novel class to be developed globally.

£2.7m of this funding came from a syndicate of investors, led by Archangels, and includes existing investors Barwell PLC, TRI Cap and the Scottish Investment Bank, the investment arm of Scottish Enterprise. In addition, MGB Biopharma was the recipient of a prestigious £1.3m funding award announced in June by Innovate UK, formerly the Technology Strategy Board (TSB), under its Biomedical Catalyst programme.

Further development of MGB-BP-3 on track

MGB Biopharma has made substantial progress in finalising preparations for the Phase I trial for the oral formulation of lead candidate MGB-BP-3 for the treatment of C. difficile infections. In December 2014 MGB Biopharma concluded manufacturing agreements with Almac Group Ltd and Encap Drug Delivery to manufacture and fill and coat the MGB-BP-3 API respectively. These companies will supply MGB-BP-3 for upcoming clinical trials.

The Phase I trial is on track to start in the first half of 2015. Approximately 40 healthy subjects are expected to be enrolled into the single centre, double-blind, placebo controlled trial to determine the safety and tolerability of single and multiple ascending doses of oral MGB-BP-3. The trial will also examine the effect of MGB-BP-3 on normal gut flora.

In parallel, MGB Biopharma expects to complete the preclinical development of an injectable formulation of its lead product MGB-BP-3 by the end of 2015. The I.V. formulation will target major hospital-acquired Gram positive infections caused by Methicillin Resistant Staphylococcus aureus (MRSA), Vancomycin Resistant Enteroccoci (VRE) and Streptococci.

New antibiotics to treat hospital-acquired infections are urgently needed as the current last-line treatments are becoming less and less effective due to an increasing number of resistant strains of pathogenic bacteria.

Dr Stephanie Dancer joins MGB Biopharma's SAB

In June 2014, Dr Stephanie Dancer, an internationally renowned medical microbiologist, joined MGB Biopharma's scientific advisory board (SAB) to help oversee the development of MGB-BP-3.

Dr Dancer is currently a medical microbiologist in NHS Lanarkshire and has been editing the Journal of Hospital Infection for 18 years, five of which as editor-in-chief. Her current research focuses on the role of antibiotics, screening and cleaning in the control of Methicillin-resistant Staphylococcus aureus (MRSA) and other hospital pathogens.

Dr Dancer has published books, book chapters and over 120 microbiological papers in peer-reviewed journals on hospital cleaning, antimicrobial management, infection and MRSA. She trained at St Bartholomew's Hospital, London, followed by postgraduate studies at Guy's Hospital. She gained a thesis on epidemiology and biochemistry of toxin-producing Staphylococci.

Scottish Enterprise Life Sciences award shortlist

In December 2014, MGB Biopharma announced that it had been nominated and shortlisted for the 2015 Scottish Enterprise Life Sciences Annual Award for "Investment of the Year".

The awards, for which there are six categories this year, recognise excellence in companies and individuals who are making a significant contribution to the life sciences industry. MGB Biopharma is one of three shortlisted finalists in the "Investment of the Year" category. Judging criteria includes the significance of the investment to the sector and improving the Company's ability to get products to the market faster, show advancement in technology and an innovative approach to investment. The winners will be announced at the Scottish Life Sciences Annual Dinner in February.

SOURCE MGB Biopharma