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F2G Ltd announces the appointment of Ralf Schmid to the position of Chief Financial Officer

MANCHESTER, UK – 11 July 2016 – F2G Ltd, the UK-based antifungal drug discovery and development company, today announced the appointment of Ralf Schmid to the position of Chief Financial Officer, effective from 4th July 2016. Ralf brings over 20 years’ experience to F2G, with considerable expertise in M&A, licensing, public and private market transactions.

Ralf Schmid joins F2G from Nabriva Theraputics AG (NASDAQ:NBRV), where he served on the management board since the company’s inception in 2006. In his role as Chief Financial and Chief Operating Officer, Ralf was instrumental in taking the company public on NASDAQ in September 2015. He has held various senior positions in finance and administration at several multi-national companies including Sandoz where he led the spin-off of Nabriva. Ralf holds a Master’s degree in finance and economics from Otto-Friedrich-Universität Bamberg, Germany.

Ian Nicholson, CEO of F2G, commented, “Following our successful $60 million financing, I am delighted to welcome Ralf to the F2G team. His strong track record in fundraising, M&A transactions and deal structuring will be invaluable as we continue to generate positive data from our clinical trials and position the company for success.”

Ralf Schmid added, “I am very pleased to be joining F2G at this pivotal stage as the company transitions its lead programme into Phase II development and onto the market. I look forward to working with the highly experienced board and dynamic team at the company as we progress the pipeline.”

About F2G Ltd: F2G is a world leading UK biotech company focused on the discovery and development of novel therapies to treat life threatening invasive fungal infections, with experienced management & board.  F2G has discovered and developed a completely new class of antifungal agents called the orotomides. The orotomides are active against Aspergillus and other rare and resistant moulds and act via a completely different mechanism than currently marketed antifungal agents. Due to their new mechanism of action, orotomides are active against fungal infections resistant to current therapies, a growing problem globally. A small PK Phase 2 clinical trial for F901318 is planned for 2H 2016 with pivotal registration trials in Invasive Aspergillosis planned for 1H 2017 based on an accelerated regulatory pathway agreed with the relevant agencies. F901318 is being developed both as IV and oral formulations and promises to have a safe and well-tolerated profile. The company recently announced a $60 million financing to develop its pipeline of novel therapies to treat life threatening invasive fungal infections.

Contact:

F2G Ltd
Ian Nicholson | Chief Executive Officer
inicholson@f2g.com | +44 (0)161 785 1271 | www.f2g.com

Hume Brophy
Mary Clark, Supriya Mathur
f2g@humebrophy.com | +44 (0)207 862 6475

F2G Ltd Announces $60 Million Financing to Progress Development of Novel Antifungal Agents

Funding to Take Lead Compound Through to Product Approval and Development of Pipeline Assets

MANCHESTER, UK – 20 June 2016 – F2G Ltd, the UK-based antifungal drug discovery and development company, today announced that it has raised $60 million in financing to develop its pipeline of novel therapies to treat life threatening invasive fungal infections. The round was led by Sectoral Asset Management, with participation from Novo A/S, Aisling Capital and Brace Pharma Capital. Existing investors Advent Life Sciences LLP, Novartis Venture Fund, Sunstone Capital and Merifin Capital each participated in the round.

F2G has discovered and developed a completely new class of antifungal agents called the orotomides. The orotomides are active against Aspergillus and other rare and resistant moulds and act via a completely different mechanism than currently marketed antifungal agents. Existing antifungal therapies have known safety limitations and between 10-30% of patients cannot tolerate any initial given therapy. Due to their new mechanism of action, orotomides are active against infections resistant to current therapies, a growing problem globally.

F2G plans to advance its lead compound, F901318, a novel clinical stage candidate for the treatment of invasive aspergillosis and other serious rare mould infections, to completion of a pivotal registration study, and to further develop earlier stage assets in its pipeline. Aspergillosis is a serious pulmonary infection caused by Aspergillus, a common fungus that affects people with weakened immune systems or lung diseases.

Ian Nicholson, Chief Executive Officer, F2G Ltd commented: “F2G has made significant progress in the last 12 months and this financing, achieved in a tough funding environment, demonstrates investor confidence in our novel class of therapies and outstanding team. We welcome our new investors to the company and thank our existing investors for their continuing support and confidence in our team and strategy. We are now well positioned to achieve our goal of product approval in an area with significant unmet medical need and look forward to conducting our pivotal registration study.”

Dr Maha Katabi, Private Equity Partner, Sectoral Asset Management added: “We look forward to working with the F2G team and a high quality venture capital syndicate to bring an important medicine to patients with life-threatening fungal infections. We have been impressed by the progress that F2G has made to date and are pleased to support its next phase of growth.”  Dr Maha Katabi, Private Equity Partner at Sectoral Asset Management and Dr Martin Edwards, Senior Partner at Novo A/S will join the F2G Board of Directors.

About F2G Ltd: F2G is a world leading UK biotech company focused on the discovery and development of novel therapies to treat life threatening invasive fungal infections, with experienced management & board.  F2G has discovered and developed a completely new class of antifungal agents called the orotomides. The orotomides are active against Aspergillus and other rare and resistant moulds and act via a completely different mechanism than currently marketed antifungal agents. Due to their new mechanism of action, orotomides are active against fungal infections resistant to current therapies, a growing problem globally. A small PK Phase 2 clinical trial for F901318 is planned for 2H 2016 with pivotal registration trials in Invasive Aspergillosis planned for 1H 2017 based on an accelerated regulatory pathway agreed with the relevant agencies. F901318 is being developed both as IV and oral formulations and promises to have a safe and well-tolerated
profile.

Contact:
F2G Ltd
Ian Nicholson | Chief Executive Officer
inicholson@f2g.com | +44 (0)161 785 1271 | www.f2g.com

Hume Brophy
Mary Clark, Supriya Mathur
f2g@humebrophy.com | +44 (0)207 862 6475

NOVEMBER 30TH 2015. F2G Ltd, a UK based antifungal drug discovery and development company, today announced that its novel systemic antifungal product F901318 has been accepted to participate in the European Medicines Agency’s (EMA) Adaptive Pathways pilot programme.


Initiated in March 2014, the Adaptive Pathways (formerly Adaptive Licensing) pilot programme forms part of the EMA’s strategy to provide improved access to new therapies treating serious conditions where there is a high unmet medical need.
The concept of Adaptive Pathways foresees either an initial approval in a well-defined patient subgroup with a high medical need and subsequent widening of the indication to a larger patient population, or an early regulatory approval (e.g. conditional approval) which is prospectively planned, and where uncertainty is reduced through the collection of post-approval data on the medicine’s use in patients. This approach is particularly relevant for medicines with the potential to treat serious conditions with an unmet medical need and may reduce the time to a medicine’s approval or to its reimbursement for targeted patient groups. It involves balancing the importance of timely patient access with the need for adequate, evolving information on a medicine’s benefits and risks. The Adaptive Pathways approach builds on regulatory processes already in place within the existing European Union legal framework. F2G Ltd is one of only a small number of companies who have been accepted into this programme and will seek initial approval for F901318, a novel IV and oral, systemic antifungal targeted at Invasive Aspergillosis on the basis of a Phase IIb randomised controlled clinical trial.
Mr Ian Nicholson CEO said “We are delighted to have been accepted into the EMA Adaptive Pathways programme which has the potential to accelerate the approval process for F901318. This will ultimately lead to patients receiving our drug sooner than would normally be the case and will provide treatment options in settings where current choices are inadequate. We would like to thank the EMA and the European HTAs who contributed to the review and collaborative feedback on our proposal at a recent EMA/HTA parallel scientific advice meeting.”
Mr Nicholson concluded “this has been a tremendous effort by our internal team and external collaborators in order to submit such a detailed proposal to the EMA and we are grateful for the EMA’s positive review.”

About F2G Ltd

F2G is a world leading UK biotech company focusing on the discovery and development of novel therapies to treat life threatening invasive fungal disease. F2G have discovered and developed a completely new class of antifungal agents called the orotomides. The orotomides are active against Aspergillus and other filamentous moulds and act via a completely different mechanism than currently marketed antifungal agents. This means that orotomides are active against infections resistant to current therapies, a growing problem globally.
F901318 is the leading member of the orotomide class and is currently completing Phase One Intravenous and Oral clinical trials. Phase Two clinical trials in Invasive Aspergillosis and Scedosporium prolificans infections are planned for the end of 2016.
F2G is backed by leading venture capital companies including Advent Life Sciences, Novartis Venture Fund, Sunstone Capital and Merifin Capital.

SEPTEMBER 9TH 2014 | F2G Limited, the UK-based antifungal drug discovery and development company, today announced a major funding award from the Technology Strategy Board’s Biomedical Catalyst.
The prestigious £1.4 million award will expedite the development of F2G’s novel IV/oral systemic antifungal F901318. The Biomedical Catalyst project will focus on the oral Phase I clinical development of F901318 and supporting studies, and will allow the company to accelerate its clinical development activities.

F901318 is being developed by F2G as an IV and oral therapy to treat invasive aspergillosis and other life-threatening fungal infections and is a new class of antifungal acting against a new cellular target. The discovery and development of F901318 represents a major advance in the treatment of serious fungal disease as currently there are very limited treatment options and resistance is becoming a serious problem. F901318 is highly active against all known azole-resistant aspergilli.

Dr Mike Birch, F2G’s Chief Operating Officer said: “We are delighted to have been chosen to receive funding from Biomedical Catalyst as this is a highly competitive programme. The award represents significant validation of the project and project team and follows on from our successful Framework 7 award last year.”
Ian Nicholson, F2G’s CEO commented: “The Technology Strategy Board plays a major role in developing and promoting world class UK science. F901318 is a significant addition to the antifungal armoury and the Biomedical Catalyst award will accelerate its development and entry into Phase II trials.”

About F2G Ltd: Based in Manchester, UK, F2G Ltd is dedicated to the discovery and development of new and clinically superior drug classes to treat life-threatening systemic fungal infections in at-risk patient populations. The antifungal market is currently estimated at over 6 billion dollars annually and is growing steadily year on year. Market growth is expected to increase with the emergence of new clinical indications in allergies and asthma. The company has impressive internal capabilities, employing a core team of scientists with a unique understanding of the antifungal arena, supported by an experienced management team. For more information visit www.f2g.com

The Technology Strategy Board is the UK’s innovation agency. Its goal is to accelerate economic growth by stimulating and supporting business-led innovation. Sponsored by the Department for Business, Innovation and Skills (BIS), the Technology Strategy Board brings together business, research and the public sector, supporting and accelerating the development of innovative products and services to meet market needs, tackle major societal challenges and help build the future economy. For more information please visit www.innovateuk.org

PRESS RELEASE

SEPTEMBER 2ND 2014 | F2G Limited, the UK-based antifungal drug discovery and development company, today announces commencement of a Phase 1 single ascending dose study of a novel antifungal agent, F901318.

F2G Limited, the antifungal research and development company today announced a major milestone in the development of its novel IV/ oral systemic antifungal (F901318) with the commencement of a Phase I clinical study. This study initiates the IV Phase I clinical development of F901318 with the oral programme expected to commence in the near future.
F901318 is being developed by F2G to treat invasive aspergillosis and other life-threatening fungal infections and is of a novel class of antifungals acting against a new cellular target. The discovery and development of F901318 represents a major advance in the treatment of serious fungal disease as currently there are very limited treatment options and resistance to existing drugs is becoming a serious problem. F901318 is highly active against all known azole-resistant aspergilli.
Dr Tony Kennedy, F2G’s Chief Scientific Officer said: “We are delighted to commence our clinical development of F901318 based on encouraging preclinical safety and efficacy studies and I look forward to rapidly progressing both our oral and IV programmes.”
Ian Nicholson, F2G’s CEO commented: “F901318 is a significant addition to the antifungal armamentarium as there have not been any new classes of antifungal agents s approved for many years and growing resistance presents a considerable challenge in this seriously ill patient population. We believe that F901318 represents a truly innovative approach in this area and we are dedicated to providing improved treatment options for patients with life threatening aspergillus infections.”
About F2G Ltd: Based in Manchester, UK, F2G Ltd is dedicated to the discovery and development of new and clinically superior drug classes to treat life-threatening systemic fungal infections in at-risk patient populations. The antifungal market is currently estimated at over 6 billion dollars annually and is growing steadily year on year. Market growth is expected to increase with the emergence of new clinical indications in allergies and asthma. The company has impressive internal capabilities, employing a core team of scientists with a unique understanding of the antifungal arena, supported by an experienced management team. For more information visit www.f2g.com

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F2G Ltd
Lankro Way
Eccles
Manchester
United Kingdom
M30 0LX

Telephone | +44 (0)161 785 1270
Fax | +44 (0)161 785 1273
email |  contact@f2g.com


Registered in England and Wales. Company Registration No. 03578625, VAT Reg No. 712680645.