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F2G Ltd Receives European Orphan Drug Designation for its Lead Candidate F901318

MANCHESTER, UK – 09 January 2017 – F2G Ltd, a UK Biotech developing novel therapies for life threatening fungal infections, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products has granted orphan drug status to its lead clinical candidate, F901318, for the treatment of invasive Aspergillosis and rare mould infections caused by Scedosporium species.

Orphan drug designation will allow F901318 up to ten years market exclusivity following market authorisation in the EU.

F901318 is the first member of a novel class of systemic antifungal agents targeting life threatening mould infections and acting through a completely novel cellular target. F901318 is being developed for both intravenous and oral formulations and will enter Phase II clinical development in mid-2017.

Dr John H. Rex, Chief Medical Officer, F2G Ltd, said: “Given the global acknowledgement of increasing resistance of moulds to the azole antifungal class, we are delighted that the EMA has granted orphan drug status to F901318. We believe this agent will offer important therapeutic options to clinicians treating these deadly infections.”

Ian Nicholson, Chief Executive Officer, F2G Ltd, added: “Receiving the European orphan drug designation for F901318 offers certain benefits and incentives, including marketing exclusivity, that are strategically important from a regulatory and commercial perspective. The positive decision of the EMA orphan drug committee is further validation of F901318 and our development program as we look forward to accelerating our Phase II clinical programme this year. ”

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About European Union (EU) Orphan Drug Designation: The European Commission grants orphan drug designation status to provide incentives to develop medicinal products to treat, prevent or diagnose diseases or conditions that affect no more than five in 10,000 persons in the European Union.

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 limited Phase II study for F901318 is planned imminently with pivotal registration trials in Invasive Aspergillosis planned for 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
Conor Griffin, Alexia Faure, Alex Protsenko
f2g@humebrophy.com | +44 (0)207 862 6481

F2G Ltd announces the appointment of John H. Rex, MD, FACP to the position of Chief Medical Officer

MANCHESTER, UK – 05 December 2016 –  F2G Ltd, the UK-based antifungal drug discovery and development company, today announced the appointment of John H. Rex, MD, FACP to the position of Chief Medical Officer, effective from 2nd November 2016.

Dr Rex is a distinguished research scientist and a key opinion leader in the field of infectious disease therapy, in particular antifungal agents. He held the position of Senior Vice President and Head of Infection, Global Medicines Development at AstraZeneca until October 2016. Prior to joining AstraZeneca in 2003, Dr Rex was Professor of Medicine at the University of Texas Medical School at Houston. Dr Rex has been the Industry Representative on the US FDA Anti-Infective Drug Advisory Committee (2007-2011), has served as Chair of the Consensus Committee on Microbiology for the Clinical Laboratory Standards Institute (CLSI, formerly NCCLS), is a member of the Wellcome Trust Seeding Drug Discovery Committee, was formerly an Editor for Antimicrobial Agents and Chemotherapy and currently serves on several editorial boards. He holds a BA in Biochemistry from Rice University as well as an MD from Baylor College of Medicine in Texas. Dr Rex has served as a non-executive director of F2G since September 2012 and is an Operating Partner at Advent Life Sciences.

Ian Nicholson, Chief Executive Officer, F2G Ltd commented: “John’s guidance and insight have been instrumental in shaping F2G’s development and regulatory strategy.  We are delighted that he is now able to increase his commitment to the company as we progress our new class of antifungal agents into our next clinical trials.”

John Rex added: “I am delighted to have the opportunity to work more closely with F2G as we take the first orotomide antifungal forward through Phase 2 and Phase 3. Just as with antibacterial resistance, antifungal resistance is a growing threat and F2G’s discovery of an entirely novel class of IV/PO antifungal agent is a key part of the global response to this challenge.”

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 limited Phase II study for F901318 is planned imminently with pivotal registration trials in Invasive Aspergillosis planned for 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
Conor Griffin, Alexia Faure, Alex Protsenko
f2g@humebrophy.com | +44 (0)207 862 6475

F2G Ltd announces publication of initial F901318 data in scientific journal PNAS

F901318 represents a novel class of antifungal drug, the orotomides

Currently in clinical development for the treatment of invasive aspergillosis

MANCHESTER, UK – 26 October 2016 – F2G Ltd, the UK-based antifungal drug discovery and development company, today announced the publication of the initial F901318 data in the prestigious scientific journal Proceedings of the National Academy of Sciences (PNAS), of their work in elucidating the mechanism of action of its novel orotomide antifungal – lead candidate F901318. The study entitled “F901318 represents a novel class of antifungal drug that inhibits dihydroorotate dehydrogenase” can be found here: http://www.pnas.org/content/early/2016/10/24/1608304113.abstract

The identification of dihydroorotate dehydrogenase (DHODH) as the mechanism by which F901318 inhibits and kills Aspergillus fumigatus was a major breakthrough differentiating F901318 from all other systemic antifungal agents. DHODH represents one of only a handful of clinically validated antifungal drug targets. The paper describes the genetic and biochemical techniques used to identify and conclusively confirm DHODH as the target of F901318 and also the in vivo activity of the drug in severe infection models.

Aspergillosis is a serious pulmonary infection caused by Aspergillus, a common fungus that affects people with weakened immune systems or lung diseases. Due to its novel mechanism of action, F901318 is active against drug resistant Aspergillus species and other rare moulds offering potentially life-saving therapy options.

Dr Jason Oliver, Lead author and Head of Biochemistry, F2G Ltd said: “We are delighted that PNAS recognised the importance of our work in the identification and validation of DHODH as an antifungal target. New antifungal drugs that act via novel mechanisms are urgently needed to combat the high mortality of invasive fungal disease and the emergence of resistance to existing therapies. We are focussed on exploiting DHODH fully to develop the next generation of systemic antifungals.”

Ian Nicholson, Chief Executive Officer, F2G Ltd added: “The antifungal pipeline has failed to produce new antifungal drugs with mechanisms of action different from those of existing classes in the past 15 years since caspofungin was licensed in 2001. F901318 is active against drug resistant Aspergillus species and other rare moulds offering potentially life-saving therapy options. We are thrilled that the hard work and dedication of Jason and his team has resulted in this publication in such a leading peer reviewed international journal.”

F2G plans to advance its lead compound, F901318 to completion of a pivotal registration study, and to further develop earlier stage assets in its 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 limited Phase II study for F901318 is planned imminently with pivotal registration trials in Invasive Aspergillosis planned for 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, Alex Protsenko
f2g@humebrophy.com | +44 (0)207 862 6475

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

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Contact us

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.