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F2G to Present at the Evercore ISI HealthCONx Conference

F2G will be present in the Evercore ISI HealthConX Conference on Wednesday 28th November 2018 at the Boston Harbor Hotel, Boston MA. Ian Nicholson, Chief Executive, will participate in the Antifungal panel discussion at 11:45am Eastern time.


PRESS RELEASE

Luxembourg, 22 November 2018

EU supports F2G Biotech in Austria with EUR 24 million for antifungal research and innovation

● EIB financing strengthens F2G´s research and innovation
● Financing is provided under the InnovFin Infectious Diseases Finance Facility (IDFF) funded by Horizon 2020, the EU’s research and innovation programme

The European Investment Bank (EIB) is lending EUR 24 million to Austrian F2G Biotech GmbH, a research-intensive company, focusing on the discovery and development of novel drugs to treat life threatening fungal diseases. EIB´s transaction is supported by ‘InnovFin – Infectious Diseases Finance Facility’ (IDFF) run under Horizon 2020, the EU research and innovation programme. This allows EIB to fund high-risk projects in the area of infectious diseases, where the risk is linked to the successful development of a compound, drug or medical device, and to its future commercialisation. F2G will be spending most of its resources on R&D, in particular on the clinical trials of its lead compound “Olorofim”.

EIB Vice-President Andrew McDowell, who is responsible for operations in Austria at the Bank, underlined: “Fungal infection typically affects the immune-compromised patient where mortality rates are often very high. Our investment in F2G contributes to fighting Antimicrobial Resistance (“AMR”), which is an area of significant concern for the scientific medical community. In particular, in the area of resistant fungi, there are very few drug candidates available, whereas resistance against the incumbent treatments is increasing year after year in multiple countries. To support a highly innovative company such as F2G demonstrates true European added value.”

Ian Nicholson, CEO of F2G Ltd commented: “We are very pleased by this support and strong endorsement from the EIB. InnovFin aims to support innovation and fast growing European companies. The funding will allow F2G to continue the development of a new, first- in-class anti-fungal drug for a patient population with very limited treatment options and a high medical need. Due to its novel mechanism of action, our lead candidate, Olorofim, is active against drug resistant Aspergillus species and other rare moulds offering potentially life-saving therapy options.”

Ralf Schmid, CFO and Managing Director of F2G Biotech GmbH, added: “F2G is a truly European company. Our clinical studies have a strong focus in Europe given the high prevalence of Aspergillosis and other rare moulds in several European countries. The EIB financing recognises the potential of orotomides, a completely new class of antifungal agents”.
Carlos Moedas, Commissioner for Research, Science and Innovation, said: “This loan demonstrates how we can use innovative financing mechanisms to address important public health needs. Antifungal resistance has been rising over the recent years and represents a major concern in clinical practice. This is why we support the discovery and development of new drugs to treat life-threatening fungal diseases through the EU research and innovation programme, Horizon 2020.”

Background:

European Investment Bank
The European Investment Bank (EIB) is the long-term lending institution of the European Union, owned by its Member States. It makes long-term finance available for sound investment in order to contribute towards EU policy goals.

About F2G
F2G is a world-leading UK and Austrian based Biotech company (F2G Ltd and F2G Biotech GmbH) focused on the discovery and development of novel therapies to treat life threatening invasive fungal infections. F2G has discovered and developed a completely new class of antifungal agents called the orotomides, active against Aspergillus and other rare and resistant moulds, that act via a completely different mechanism than currently marketed agents. A Phase IIb Open Label study is currently ongoing focussing on invasive aspergillosis, scedosporiosis and other rare and resistant mould infections. Olorofim is being developed both as IV and oral formulations and promises to have a safe and well-tolerated profile.

About EU´s InnovFin IDFF programme
Under Horizon 2020, the EU research and innovation programme for 2014-20, the ‘Infectious Diseases Finance Facility (IDFF)’ provides financial products ranging from standard debt to equity-type financing for amounts typically between EUR 7.5 million and EUR 75 million, to innovative players active in developing innovative vaccines, drugs, medical and diagnostic devices or novel research infrastructures for combatting infectious diseases. Project costs may include clinical trial costs, set-up of commercialization such as market access, development of prototypes or industrial roll out of novel equipment, pre-clinical R&D costs and working capital requirement. This facility is delivered directly by the EIB.

Press contacts:

EIB: Christof Roche, c.roche@eib.org, tel.: +352 43 79 89013/mobile: +32 479 65 05 88
Website: www.eib.org/press – Press Office: +352 4379 21000 – press@eib.org

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

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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.