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F2G expands investor syndicate and progresses Phase IIb study for novel antifungal

● New investor Morningside Venture joins existing blue-chip investor syndicate
● Company accelerates global phase 2b study of lead candidate olorofim to develop its novel antifungal in an area of high unmet medical need

MANCHESTER, UK – 07 January 2019 – F2G Ltd, a UK- and Austria-based Biotech developing novel therapies for life-threatening fungal infections, today announced that it has raised funding from life science investor Morningside Venture Investments Ltd. (Morningside). This funding follows a EUR 24 million loan from the European Investment Bank (EIB) in November 2018 and allows F2G to accelerate its worldwide Phase 2b study for its lead candidate olorofim (formerly F901318) as a treatment for invasive fungal infections due to difficult to treat moulds such as azole-resistant aspergillosis.

F2G has discovered and is developing the orotomides, a novel class of antifungal agents. The orotomides act via a different mechanism than currently marketed antifungal agents and are active against Aspergillus and other rare and resistant moulds. Due to their mechanism of action, orotomides have fungicidal activity against fungal infections resistant to current therapies, a growing global problem where limited treatment options have led to a high medical need.

The Phase 2b study for olorofim is a global open-label study in patients who have limited treatment options for difficult-to-treat invasive fungal mould infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mould infections. There will be study sites across at least 6 countries. With 12 centres open in 5 countries (AU, BE, ES, NL, US), investigators in the study are recruiting patients well ahead of schedule. A further 20 centres will open in 2019. Olorofim is being developed both as IV and oral formulations.

Ian Nicholson, CEO of F2G Ltd commented: “The investment from Morningside represents further validation and support of our strategy to develop a new, first-in-class anti-fungal drug. Morningside’s addition further strengthens our investor syndicate which includes Novo Holdings, Advent Life Sciences, Merifin Capital and Brace Pharma, who represent a renowned and committed shareholder base with a track record of supporting successful next-generation companies.

“The recent funding from the EIB along with this additional investment from Morningside will allow F2G to progress the development of our lead candidate olorofim for a patient population with very limited treatment options and a high medical need. Recruitment for our phase 2b programme is ongoing and has already seen the enrolment of patients in Europe, Australia, and the US.”

Jason Dinges, an investment advisor to Morningside added: “We believe F2G’s programmes have the potential to bring real impact in the treatment of life-threatening fungal diseases. We are very excited to support this proven management team as it seeks to further the development of olorofim in treating drug-resistant Aspergillus species and other rare moulds.”

In November 2018, F2G’s Austrian branch, F2G Biotech GmbH, received a EUR 24 million loan from the European Investment Bank (EIB) under the ‘InnovFin – Infectious Diseases Finance Facility’ (IDFF) run under Horizon 2020, the EU research and innovation programme. The EIB financing recognises the potential of orotomides, a completely new class of antifungal agents to treat life-threatening fungal diseases.

Contact:

F2G Ltd
Ian Nicholson | Chief Executive Officer
Ralf Schmid | Chief Financial Officer

Tel: +44 (0)161 785 1271 (UK)
+43 (0)1 997 4267 (A)

Optimum Strategic Communications
Mary Clark / Supriya Mathur / Ellie Blackwell
Email: F2G@optimumcomms.com
Tel: +44 (0) 203 950 9144

About F2G
F2G is a world-leading UK- and Austria-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. The orotomides target dihydroorotate dehydrogenase (DHODH), a key enzyme in the de novo pyrimidine biosynthesis pathway. This is a completely different mechanism from that of the currently marketed antifungal agents and gives the orotomides fungicidal activity against a broad range of rare and resistant fungal mould infections. Olorofim (formerly, F901318) is F2G’s leading candidate from this class and is in a Phase 2b open-label study focussing on rare and resistant invasive fungal infections such as aspergillosis (including azole-resistant strains), scedosporiosis, and lomentosporiosis. Olorofim is being developed both as IV and oral formulations. www.f2g.com

Morningside Group
Morningside is a diversified investment group founded in 1986 by the Chan family of Hong Kong. It is engaged primarily in private equity and venture capital investments. The group has investments in North America, Europe, across Asia-Pacific, and since 1992, in Mainland China. Morningside is an active investor in early-stage life science companies formed around new technologies that represent a high degree of novelty over existing technologies. More information is available at www.morningside.com

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. ”

###

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

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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.