F2G

Press Release.

Application submitted under priority review with PDUFA target action date set for June 17, 2023

NDA submission is based on positive data from ongoing Phase 2b open-label study of oral olorofim in 100 patients with invasive fungal infections with limited or no treatment options

F2G is continuing preparations for a possible U.S. commercial launch of oral olorofim in 2nd half of 2023

PRINCETON, New Jersey, December 19, 2022 – F2G Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for olorofim for the treatment of invasive fungal infections in patients who have limited or no treatment options.

F2G has requested approval of the NDA under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) for a limited, well-defined population with invasive fungal infections and limited or no treatment options. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of June 17, 2023

The NDA is supported by strong efficacy data and a good tolerability profile seen during treatment of the first 100 patients in the Phase 2b open-label study, all of whom had limited or no treatment options for either proven invasive fungal infection (including aspergilllosis, lomentosporiosis, scedosporiosis, Scopulariopsis infections, and refractory extrapulmonary coccidioidomycosis) or probable pulmonary invasive aspergillosis (Study 32, NCT03583164).

“Invasive fungal infections cause substantial morbidity and mortality, particularly among immunosuppressed patients, and can prove to be lethal in also healthy individuals when they get into deeper tissues. Effective therapies do not currently exist for some of these fungi. And even when therapies exist, some patients with invasive infections may be refractory or unable to tolerate existing antifungal treatments, thus underscoring the urgent need for new and effective treatments,” said John H. Rex, MD, chief medical officer of F2G. “Olorofim is a novel mechanism antifungal therapy from the newly discovered orotomide class. It provides a new option for patients who have exhausted treatment alternatives.”

Francesco Maria Lavino, chief executive officer of F2G, added,

“We are committed to addressing rare fungal infections, and the acceptance of filing of olorofim NDA for use in this well-defined and high-need population marks a major milestone toward our goal of bringing new options to these patients. We are building an experienced commercial team in preparation for U.S. launch, pending FDA approval. If approved, olorofim will be the first of a new class of antifungal drugs.”

Olorofim is the only antifungal medication to be awarded Breakthrough Therapy Designation by the FDA. Olorofim works through a novel mechanism of action, different from existing classes of antifungals, exerting fungal cell death through inhibition of the enzyme dihydroorotate dehydrogenase (DHODH) in the pyrimidine synthesis pathway. It is active in vitro against Aspergillus spp. (including azole-resistant and cryptic species), rare molds (e.g., Lomentospora prolificans, Scedosporium spp., Scopulariopsis spp.), and dimorphic fungi (e.g., Coccidioides spp.).

About Olorofim

Olorofim (formerly, F901318) is F2G’s leading candidate from the orotomide class and is currently being investigated in a Phase 2b open-label study in patients who have limited treatment options for difficult-to-treat invasive, rare fungal mold infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mold infections. F2G has initiated a global Phase 3 trial (“OASIS”) to compare treatment with olorofim versus AmBisome® followed by standard of care (SOC) in patients with proven or probable invasive fungal infection due to Aspergillus species (NCT05101187). Olorofim has received orphan drug designation from the FDA for the treatment of coccidioidomycosis, scedosporiosis (including lomentosporiosis), invasive Scopulariopsis, and invasive aspergillosis. Olorofim has also received orphan drug designation from the European Medicines Agency (EMA) for the treatment of invasive aspergillosis, invasive scedosporiosis (including lomentosporiosis), and invasive Scopulariopsis. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis. Olorofim has received Breakthrough Therapy Designation for both “treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species” and “treatment of Central Nervous System (CNS) coccidioidomycosis refractory or otherwise unable to be treated with standard of care therapy.” Olorofim is not approved by the FDA or any other regulatory agency.

About F2G

F2G is a biotech company with operations in the UK, US, and Austria focused on the discovery and development of novel therapies to treat potentially life-threatening invasive fungal infections. F2G has discovered and developed a completely new class of antifungal agents called the orotomides which selectively target 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 mold infections. For more information, please visit: www.f2g.com

Forward-Looking Statements

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also, for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

Media Contact:

Gloria Gasaatura
LifeSci Communications
+1 646 970 4688
ggasaatura@lifescicomms.com

Press Release.

MANCHESTER, UK, 4 August 2022 – F2G Ltd, a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat life-threatening rare fungal infections with a high unmet medical need, today announces a $70 million financing. The financing was co-led by new investors Forbion and Sofinnova Partners with strong participation from existing investors, Novo Holdings, Morningside Ventures, Cowen Healthcare Investments and Advent Life Sciences. The proceeds from the financing in addition to the $480 million from the recent strategic collaboration with Shionogi & Co., Ltd., will enable F2G to advance late-stage development and commercialization in the US of olorofim, a novel oral antifungal therapy to treat invasive aspergillosis (IA) and other rare mold infections. Nanna Lüneborg of Forbion and Joe Anderson of Sofinnova Partners will join the F2G Board of Directors.

Olorofim represents the first novel class of antifungals developed in the past 20 years and is the only antifungal medication to be awarded a Breakthrough Therapy Designation for multiple indications by the US Food and Drug Administration (FDA). Olorofim works through a unique mechanism of action, different from existing classes of antifungals, exerting fungicidal activity through inhibition of the pyrimidine synthesis pathway. It is anticipated to be used to treat patients with a serious invasive, rare fungal disease where existing treatments are inappropriate or no longer effective. Data from F2G’s open Phase 2b study in patients with rare and resistant molds, who have limited treatment options, will be presented at ID Week annual conference in October.

Francesco Maria Lavino, Chief Executive Officer of F2G, said:

“We are delighted to attract this additional capital from such high caliber late-stage investors to F2G, and welcome Nanna and Joe to the Board. Their experience will be invaluable as we move to our next stage of growth. This is a pivotal year for the Company. We are building a world class team with commercial, operational and dealmaking experience as we prepare for final development and commercialization of olorofim in the US. If approved, olorofim is expected to be the first new class of anti-fungal with a novel, differentiated mechanism of action in more than 20 years and will address genuine unmet needs in conditions with high morbidity and mortality.”

Nanna Lüneborg, General Partner at Forbion, commented:

“The Forbion Growth Opportunities Fund II focuses on promising late-stage European life sciences companies like F2G. We have been very impressed with the significant progress achieved to date and we are pleased to support this highly impactful Company in its next stage of growth as it pursues commercialization of olorofim in the US.”

Joe Anderson, Partner at Sofinnova Partners, said:

“We aim to support outstanding companies developing innovative treatments for life-threatening disease. With its highly experienced team, F2G has made significant progress over recent years and is now close to bringing its breakthrough product to market for patients with limited treatment options. We look forward to working with management, the board and our co-investors as the company moves into this important phase in its development and growth.”

In May 2022, F2G entered a $480million strategic collaboration with Shionogi & Co., Ltd. to develop and commercialize olorofim in Europe and Asia which included $100 million in upfront payment and $380 million in regulatory and commercialization milestones plus double-digit royalties on sales.

END

For further information please contact:

F2G Ltd
Francesco Maria Lavino | 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 / Charlotte Hepburne-Scott / Manel Mateus / Zoe Bolt
Email: F2G@optimumcomms.com
Tel: +44 (0) 203 882 9621

Notes to Editors

About F2G

F2G is a biotech company with operations in the UK, US, and Austria focused on the discovery and development of novel therapies to treat potentially life-threatening invasive fungal infections. F2G has discovered and developed a completely new class of antifungal agents called the orotomides which selectively target 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 mold infections. For more information, please visit: www.f2g.com

About olorofim

Olorofim (formerly, F901318) is F2G’s leading candidate from the orotomide class and is currently in a Phase 2b open-label study (ClinicalTrials.gov Identifier: NCT03583164) in patients who have limited treatment options for difficult-to-treat invasive, rare fungal mold infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mold infections. F2G has initiated a global Phase 3 trial (“OASIS”)2 to compare treatment with olorofim versus AmBisome® followed by standard of care (SOC) in patients with lower respiratory tract invasive fungal disease caused by proven or probable infection with Aspergillus species. Olorofim has received orphan drug status from the European Medicines Agency for the treatment of invasive aspergillosis and invasive scedosporiosis. Olorofim has also received orphan drug status from the FDA for the treatment of coccidioidomycosis scedosporiosis, and invasive aspergillosis. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis.

About invasive aspergillosis

Aspergillosis is a fungal infection caused by Aspergillus species of mold which are commonly found all over the world. Most of these molds, in most people, are harmless. However, aspergillus is transmitted to humans through inhalation and may cause a broad spectrum of disease ranging from hypersensitivity reactions to direct invasion and destruction of tissue. Invasive aspergillosis is a rare disease that can occur in over 10% of some high-risk immunosuppressed populations with mortality exceeding 80%.

About Forbion
Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the (bio-) pharmaceutical space. Forbion manages well over €2 billion across multiple fund strategies that cover all stages of (bio-) pharmaceutical drug development. Forbion’s current team consists of over 30 life sciences investment professionals that have built an impressive performance track record since the late nineties with successful investments in 92 companies. The firm is a signatory to the United Nations Principles for Responsible Investment. Besides financial objectives, Forbion selects investments that will positively affect the health and well-being of patients. Its investors include the EIF, through its European Recovery Programme (ERP), LfA, Dutch Venture Initiative (DVI), AMUF and EFSI facilities and KfW Capital through the Programme, “ERP – Venture Capital Fonds investments.” Forbion operates a joint venture with BGV, the manager of seed and early-stage funds, especially focused on Benelux and Germany.
For more information, please visit: www.forbion.com

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm in life sciences, specializing in healthcare and sustainability. Based in Paris, London and Milan, the firm brings together a team of professionals from all over the world with strong scientific, medical and business expertise. Sofinnova Partners is a hands-on company builder across the entire value chain of life sciences investments, from seed to later-stage. The firm actively partners with ambitious entrepreneurs as a lead or cornerstone investor to develop transformative innovations that have the potential to positively impact our collective future.

Founded in 1972, Sofinnova Partners is a deeply established venture capital firm in Europe, with 50 years of experience backing over 500 companies and creating market leaders around the globe. Today, Sofinnova Partners has over €2.5 billion under management. For more information, please visit: www.sofinnovapartners.com.

Press Release.

• Shionogi to conduct clinical trials, subsequent registration and commercialization of olorofim for invasive aspergillosis IA in Europe and Asia
• F2G to receive u pfront payment of $100 m and share development costs
• F2G will also be eligible for additional regulatory and commercial milestones of up to $380 m , as well as double digit royalties on net sales

OSAKA, Japan, and MANCHESTER, UK, May 16, 2022 – Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) and F2G Ltd.（Head Office: Manchester, UK; CEO: Francesco Maria Lavino; hereafter “F2G”）today announced that they have entered a strategic collaboration to develop and commercialize the new antifungal agent olorofim for invasive fungal infections in Europe and Asia.

Olorofim is a novel oral antifungal therapy developed by F2G to treat invasive aspergillosis (IA) and other rare mold infections. Olorofim works through a unique mechanism of action, different from existing classes of antifungals, exerting fungicidal activity through inhibition of the pyrimidine synthesis pathway. Olorofim represents the first novel antifungal class developed in the past 20 years and is the only antifungal medication to be awarded a Breakthrough Therapy Designation (BTD) for multiple indications by the FDA.

Under the terms of the agreement, Shionogi will conduct the clinical trials and subsequent registration and commercialization of olorofim for IA in Europe and Asia. Shionogi will make an upfront payment to F2G of $100 million and share development costs in global studies. F2G will also be eligible to receive additional regulatory and commercial milestones of up to $380 million, as well as double-digit royalties on net sales.

“We are delighted to announce this partnership. By joining forces with Shionogi, we will be able to progress the development of olorofim with a partner which has a proven track record in both global drug development and business development to effectively deliver a potentially life-saving therapy to patients globally,”

said Francesco Maria Lavino, Chief Executive Officer of F2G.

 

“As F2G prepares to commercialize olorofim in the US, we are excited to work closely together with Shionogi to address the unmet medical need caused by invasive aspergillosis and other rare mold diseases around the world.”

“Shionogi is committed to ‘Protect people worldwide from the threat of infectious diseases’ as our key focus. We are pleased to partner with F2G, which is boldly tackling fungal infections where new drug development is difficult.”

said Isao Teshirogi, Ph.D., CEO of Shionogi.

“We will continue to address unmet medical needs in infectious diseases, and to work towards total care for this area. As part of this mission and through our partnership with F2G, we hope to be able to provide new antifungal drugs to patients to protect people’s health from life-threatening, invasive fungal infections.”

Invasive aspergillosis is a rare disease that can be fatal, occurring primarily in immunocompromised patients, including those having received cancer chemotherapy or hematopoietic stem cell transplantation. Other rare fungi, such as scedospurium or lomentospora, may also infect patients with compromised immunity. Existing antifungal therapies may not be appropriate treatments due to drug-drug interactions, tolerability or other serious side-effects, or are not effective due to resistance. For these patients, treatment options are limited.

Olorofim is anticipated to be used to treat patients with serious invasive fungal disease where existing treatments are inappropriate or no longer effective. Both companies believe olorofim provides hope to patients with, and physicians treating, serious invasive fungal infections.

About Shionogi

Shionogi & Co., Ltd. is a leading global research-driven pharmaceutical company based in Japan, dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.”

The company has discovered and developed novel medicines for HIV, influenza and antimicrobial resistance, and currently markets products in several therapeutic areas including anti-infectives with the first siderophore cephalosporin, cefiderocol. For more information, please visit https://www.shionogi.com/global/en

About F2G

F2G is a biotech company with operations in the UK, US, and Austria focused on the discovery and development of novel therapies to treat potentially life-threatening invasive fungal infections. F2G has discovered and developed a completely new class of antifungal agents called the orotomides which selectively target 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 mold infections. For more details, please visit the F2G web site.

About olorofim

Olorofim (formerly, F901318) is F2G’s leading candidate from the orotomide class and is currently in a Phase 2b open-label study1. F2G is currently initiating a global Phase 3 trial (“OASIS”)2 to compare treatment with olorofim versus AmBisome® followed by standard of care (SOC) in patients with lower respiratory tract invasive fungal disease caused by proven or probable infection with Aspergillus species. Olorofim has received orphan drug status from the European Medicines Agency for the treatment of invasive aspergillosis and invasive scedosporiosis. Olorofim has also received orphan drug status from the FDA for the treatment of coccidioidomycosis scedosporiosis, and invasive aspergillosis. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis.

About invasive aspergillosis

Aspergillosis is a fungal infection caused by Aspergillus species of mold which are commonly found all over the world. Most of these molds, in most people, are harmless. However, aspergillus is transmitted to humans through inhalation and may cause a broad spectrum of disease ranging from hypersensitivity reactions to direct invasion and destruction of tissue. Invasive aspergillosis is a rare disease that can occur in over 10% of some high-risk immunosuppressed populations with mortality exceeding 80%.

Forward-Looking Statements

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also, for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

References
1.  https://clinicaltrials.gov/ct2/show/NCT03583164
2.  https://clinicaltrials.gov/ct2/show/NCT05101187

For Further Information, Contact:
SHIONOGI Website Inquiry Form https://www.shionogi.com/global/en/contact.html.

For F2G, contact Petra Taylor-Stadler
Email: ptaylor@f2g.com
Tel: +43 (0)1 997 4267

Optimum Strategic Communications
Mary Clark/ Charlotte Hepburne-Scott/ Supriya Mathur/ Zoe Bolt
Email: F2G@optimumcomms.com
Tel: +44 (0) 203 882 9621

Press Release.

• Brings substantial pharmaceutical expertise to lead the development and commercialization of olorofim in the USA
• Ian Nicholson stepping down to pursue non-executive roles

MANCHESTER, UK / VIENNA, AUSTRIA, April 12, 2021 — F2G Limited (“F2G”), a clinical-stage biopharmaceutical company focused on life threatening fungal diseases, announces that Francesco Maria Lavino has been appointed Chief Executive Officer (CEO) and member of the Board of F2G. Mr. Lavino brings substantial specialty pharmaceutical leadership and expertise in the antifungal arena, including most notably, serving as AVP, Global Brand Leader, Anti-infectives portfolio at Merck & Co. and as Chief Commercial Officer of Nabriva Therapeutics, Inc. (NASDAQ: NBRV). Ian Nicholson is stepping down as CEO following eight years of dedicated service to F2G to pursue non-executive roles and will provide support to ensure an effective transition.

Mr. Lavino is based in Princeton, New Jersey, USA, and will lead the development and commercialization of olorofim for the treatment of patients who have limited treatment options for difficult-to-treat invasive fungal mold infections such as azole-resistant aspergillosis, coccidioidomycosis, scedosporiosis, lomentosporiosis, and other rare mold infections.

“We are delighted to welcome Francesco Lavino to F2G. He is a highly experienced leader with a proven track record of working to create significant value for shareholders. We believe we have a strong team in place to lead F2G into its next phase of growth. The team will focus on the US and worldwide opportunities to help patients with serious fungal infections in need of additional treatment options,”

said Patrick Vink, Chairman of F2G Ltd.

“I would like to thank Ian Nicholson for his dedicated leadership in transforming F2G from a preclinical company into the strong Company it is today with two FDA Breakthrough Therapy designations for its lead compound olorofim, and an NDA filing expected in 2022. Ian has successfully raised significant capital, most recently a $60 million round in 2020, which has enabled the generation of excellent data supporting the strong efficacy and safety profile of olorofim in rare fungal infections. I am pleased he will continue to support the transition to ensure the further success of F2G.”

Francesco Maria Lavino, CEO of F2G Ltd, commented:

“This is a transformational time to join F2G and I am very excited to lead the Company through its next phase of growth and to maximize the full potential of olorofim, a first-in-class, oral agent for the treatment of severe fungal infections including invasive pulmonary aspergillosis and Valley Fever. The fact that olorofim is the only anti-fungal agent ever to have been granted FDA Breakthrough Therapy designation underscores its potential to positively impact the treatment of patients with these life-threatening diseases.”

Francesco has over twenty years of pharma and biotech experience in strategic and operational roles in US, Europe and Emerging Markets. He served as Chief Commercial Officer at Nabriva Therapeutics from July 2017 where he led the US commercial organization buildout and the launch of Xenleta, a first-in-class new antibiotic treatment. Prior to Nabriva, he spent almost 15 years at Merck and Cubist Pharmaceuticals in different commercial roles and therapeutic areas at global, regional and country level. He held the position of Global Brand Leader for the Anti-Infective Portfolio (2015-2017) and was the commercial lead of the Merck Antifungal Portfolio in EMEAC (2009-2010) and Globally (2011-2013). Francesco began his career in pharmaceutical sales in Italy and holds a BS in Pharmacy from Federico II University of Naples, Italy and a MBA from SDA Bocconi School of Management in Milan, Italy.

Contact:

F2G Ltd
Francesco Maria Lavino | 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 / Charlotte Hepburne-Scott
Email: F2G@optimumcomms.com
Tel: +44 (0) 203 950 9144

Notes to Editors:

About Olorofim / Clinical trial
The Phase 2b study for olorofim (ClinicalTrials.gov Identifier: NCT03583164) is a global open-label study in patients who have limited treatment options for difficult-to-treat invasive fungal mold infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mold infections.

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 selectively target fungal 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 mold infections. Olorofim (formerly, F901318) is F2G’s leading candidate from this class and is in a Phase 2b open-label study focusing on rare and resistant invasive fungal infections such as aspergillosis (including azole-resistant strains), scedosporiosis (including lomentosporiosis). Olorofim has received orphan drug status from the European Medicines Agency for the treatment of invasive aspergillosis and invasive scedosporiosis. Olorofim has received orphan drug status from the US FDA for the treatment of coccidioidomycosis, lomentosporiosis/scedosporiosis, and invasive aspergillosis. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation Invasive for aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis. www.f2g.com

Press Release.

In Phase 2b development for the treatment of life-threatening fungal infections

First antifungal agent to receive Breakthrough Therapy Designation

New second Breakthrough Therapy Designation for CNS Valley Fever (coccidioidomycosis)

MANCHESTER, UK / VIENNA, Austria – October 22, 2020 – F2G Ltd, a UK- and Austria-based biotech company developing novel therapies for life-threatening systemic fungal infections, announced today that the US Food and Drug Administration (FDA) has granted an additional Breakthrough Therapy Designation to its lead first-in-class candidate, olorofim, for the indication of ‘Treatment of Central Nervous System (CNS) coccidioidomycosis refractory or otherwise unable to be treated with standard of care therapy’. This is the second Breakthrough Therapy Designation for olorofim; a designation was granted previously on 11 November 2019 for ‘Treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species’. Olorofim (formerly F901318) is the first antifungal agent to be granted Breakthrough Therapy Designation.

Olorofim has orphan drug designation in the United States for coccidioidomycosis, an endemic fungal infection with a geographic distribution focused mainly in the desert Southwest of the United States but also including Mexico, Central America, and South America. Infection begins by inhalation and can spread to any part of the body, even in otherwise healthy individuals. Spread to the brain is particularly feared as it produces a devastating illness that cannot always be controlled with any currently available agent.

Patients with coccidioidomycosis are being studied in an ongoing open-label single-arm Phase 2b study (ClinicalTrials.gov Identifier: NCT03583164) in patients with proven invasive fungal disease (IFD) or probable invasive aspergillosis (IA) and either refractory disease, resistance, or intolerance to available agents. Olorofim has been well tolerated across more than 30 years of cumulative patient dosing days with a median therapy duration of 12 weeks. Preliminary data from this study were provided to the FDA as part of the Breakthrough Therapy Designation submission.

Breakthrough Therapy Designation is an FDA process designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition and is granted based on preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

Breakthrough Therapy Designation conveys all the features of fast track designation, more intensive FDA guidance on an efficient drug development program, an organisational commitment by FDA to involve senior managers, and eligibility for rolling review and priority review.

Commenting on the news, Ian Nicholson, CEO of F2G Ltd, said:

“The granting of a second FDA Breakthrough Therapy Designation will further support our goal of rapidly developing this novel treatment for patients suffering from serious and life-threatening fungal infections. Olorofim acts via a novel and differentiated mechanism to traditional antifungals, and preliminary data have indicated that it is efficacious in tackling life-threatening invasive fungal infections that cannot be managed with currently approved agents.

“Our Phase 2b programme is on track with over 85 patients recruited in Europe, Asia, and the US. We look forward to working closely with the US FDA to accelerate development of this therapy for patients having limited or no approved treatment options for an invasive mold infection.”

Professor George Thompson, UC Davis and Investigator for the Phase 2b study said:

“This news is very exciting for clinicians caring for patients with Valley Fever (coccidioidomycosis) as spread to the brain is the most-feared complication of infection with this fungus. Unfortunately, available drugs are not curative, must be administered as life-long therapy, and are associated with substantial toxicity. The news that olorofim has encouraging preliminary clinical data that support Breakthrough Therapy Designation brings realistic hope that we can change the paradigm for managing this devastating infection.”

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 / Charlotte Hepburne-Scott
Email: F2G@optimumcomms.com
Tel: +44 (0) 203 950 9144

Notes to Editors:

About Olorofim / Clinical trial
The Phase 2b study for olorofim (ClinicalTrials.gov Identifier: NCT03583164) is a global open-label study in patients who have limited treatment options for difficult-to-treat invasive fungal mold infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mold infections. More than 40 centres are currently open in nine countries (AU, BE, DE, ES, IS, NL, TH, UK, USA) and a further 10 will open in 2020/2021. Olorofim is being developed both as IV and oral formulations.

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 selectively target fungal 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 mold 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 (including lomentosporiosis). Olorofim has received orphan drug status from the European Medicines Agency for the treatment of invasive aspergillosis and invasive scedosporiosis. Olorofim has received orphan drug status from the US FDA for the treatment of coccidioidomycosis, lomentosporiosis/scedosporiosis, and invasive aspergillosis. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation Invasive for aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis. Olorofim is being developed both as IV and oral formulations. www.f2g.com

Press Release.

Press Release.

MANCHESTER, UK / VIENNA, Austria – November 11, 2019 – F2G Ltd, a UK- and Austria-based biotech company developing novel therapies for life-threatening systemic fungal infections, announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its lead first-in-class candidate, olorofim (formerly F901318) for the indication of ‘Treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species’. Olorofim is the first antifungal agent to be granted Breakthrough Therapy designation.

Olorofim is currently being investigated in an open-label single-arm Phase 2b study (ClinicalTrials.gov Identifier: NCT03583164) in patients with proven invasive fungal disease (IFD) or probable invasive aspergillosis (IA) and either refractory disease, resistance, or intolerance to available agents. Olorofim has been well tolerated across more than 10 years of patient dosing days with a median therapy duration of 12 weeks. Preliminary data from this study were provided to the FDA as part of the Breakthrough Therapy designation submission.

Breakthrough Therapy designation is an FDA process designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition and is granted based on preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

Breakthrough Therapy designation conveys all the features of fast track designation, more intensive FDA guidance on an efficient drug development program, an organisational commitment by FDA to involve senior managers, and eligibility for rolling review and priority review.

Commenting on the news, Ian Nicholson, CEO of F2G Ltd, said:

“The granting of FDA Breakthrough Therapy designation is a truly transformational step for our company and will support our goal of rapidly developing this novel treatment for patients suffering from serious and life-threatening fungal infections. Olorofim acts via a novel and differentiated mechanism to traditional antifungals, and preliminary data have indicated that it is efficacious in tackling life-threatening invasive fungal infections that cannot be managed with currently approved agents.

“Our Phase 2b programme is on track with over 40 patients recruited in Europe, Australia and the US. We look forward to working closely with the FDA to accelerate development of this therapy for patients having limited or no approved treatment options for an invasive mold infection.”

Professor Sharon Chen, Westmead Hospital Sydney and Principal Investigator for the Phase 2b study said:

“This news is very exciting for clinicians caring for patients with these very serious, and devastating mold infections. We have had limited treatment options for many years and now the news about olorofim brings realistic hope that we can cure these previously treatment–refractory infections.”

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 / Charlotte Hepburne-Scott
Email: F2G@optimumcomms.com
Tel: +44 (0) 203 950 9144

Notes to Editors:

About Olorofim / Clinical trial
The Phase 2b study for olorofim (ClinicalTrials.gov Identifier: NCT03583164) is a global open-label study in patients who have limited treatment options for difficult-to-treat invasive fungal mold infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mold infections. 26 centres are currently open in six countries (AU, BE, ES, NL, USA, IS) and a further 20 will open in 2019/2020. Olorofim is being developed both as IV and oral formulations.

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 selectively target fungal 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 mold 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 (including lomentosporiosis). Olorofim has received orphan drug status from the European Medicines Agency for the treatment of invasive aspergillosis and invasive scedosporiosis. Olorofim is being developed both as IV and oral formulations. www.f2g.com

Press Release.

Brings successful track record of building and growing global businesses

MANCHESTER, UK & VIENNA, AUSTRIA – 8 April 2019 – F2G Ltd, the European biotech company developing novel therapies for life-threatening fungal infections, today announces the appointment of Dr Patrick Vink as Chairman of the Board of Directors with immediate effect. Dr Vink replaces Dr Richard J. White who stood down in December 2018.

Dr Vink has over 30 years of experience in the biotechnology and pharmaceutical industry and has a successful track record of building and growing global pharmaceutical businesses.  He was previously Chief Operating Officer at Cubist Pharmaceuticals Inc, with responsibility for global commercial operations, and the development and implementation of long- and short-term strategy. During his term, Cubist was acquired by Merck & Co.  Prior to Cubist, he was Head of the Global Hospital Business at Mylan Inc. as part of the global executive team. Before this, he was Head of Global Biopharmaceuticals at Sandoz (division of Novartis) and held senior positions at Biogen Inc Sanofi-Synthelabo, and Numico.

Dr Vink is currently on the board of several US and European publicly listed and private companies including Chairman of Acacia Pharma, Targovax and NMD Pharma and non-executive director of Spero Therapeutics, Arch Biopartners and Santhera AG. Dr Vink has an MD from the University of Leiden and an MBA from University of Rochester. He has attended a number of executive post-graduate courses at Insead and Harvard.

Ian Nicholson, CEO of F2G Ltd, said:

“We are delighted to welcome Patrick to the Board. During his career, he has been responsible for several successful new product launches and held senior roles overseeing R&D, commercial and technical operations. His breadth and depth of experience will be invaluable as we accelerate the development of our lead candidate olorofim as a treatment for rare invasive fungal infections. On behalf of the Board of Directors I would like to thank Richard for his dedication, commitment and steadfast leadership during the evolution of F2G from discovery to late stage clinical development.”

Dr Patrick Vink, Chairman of F2G, added:

“I am very pleased to join as Chairman and look forward to working closely with the team. F2G’s highly experienced management team and board, backed by renowned and committed investors, will enable the company to drive forward the development of these novel antifungals which have the potential to make a real impact to patients with life-threatening fungal diseases.”

F2G recently raised funding from life science investor Morningside Venture Investments Ltd and received a EUR 24 million loan from the European Investment Bank (EIB).

Ian Nicholson, CEO and Ralf Schmid, CFO will be attending and presenting at the 18th Annual Needham Healthcare Conference at 10:40am EDT on April 10, 2019 in New York.

For further information please contact:

F2G Ltd
Ian Nicholson | Chief Executive Officer
Tel: +44 (0)161 785 1271
Ralf Schmid | Chief Financial Officer
Tel: +43 (0)1 997 4267 (Austria)

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

Notes to Editors

About F2G

F2G is a world leading European biotech company 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

Press Release.

KaNDy Therapeutics launched to advance a breakthrough treatment in Women’s Health

Press Release:
KaNDy Therapeutics launched to advance a breakthrough treatment in Women’s Health

First-in-class once daily NT-814 spun out of NeRRe Therapeutics into new company

Stevenage, UK, September 27th 2017 – KaNDy Therapeutics has been launched today to maximise the value of NT-814, a potential breakthrough medicine for the treatment of chronic debilitating Women’s Health conditions and is backed by internationally recognised life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed Advisors.

NT-814 is a first-in-class, once daily, dual mechanism neurokinin-1,3 receptor antagonist. The medicine is being developed as a non-hormonal alternative to hormone replacement therapy for the treatment of postmenopausal vasomotor symptoms (PMVMS). NT-814 has been spun out of NeRRe Therapeutics Holdings Ltd into KaNDy Therapeutics Ltd a separate legal entity.

KaNDy Therapeutics will advance the development of NT-814 into Phase 2b in the lead indication PMVMS while also exploring its potential in other Women’s Health conditions. All formulation, pre-clinical and clinical safety and efficacy data, and intellectual property associated with NT-814 have been transferred to the new company. KaNDy Therapeutics is led by Managing Director Mary Kerr and chaired by Iain Dukes, Venture Partner at OrbiMed Advisors. The company is based at the Stevenage Bioscience Catalyst in the UK.

NT-814 has significant potential to treat multiple debilitating Women’s Health conditions by virtue of the ability to beneficially modulate dysfunctional temperature control and reproductive hormone pathways. NT-814 has already successfully completed a Phase 2a proof of concept study demonstrating its potential to reduce the frequency and severity of PMVMS, and is now being prepared to enter an international Phase 2b study in this anchor indication.

Iain Dukes, Chairman of KaNDy Therapeutics, said, “The formation of KaNDy Therapeutics enables us to maximise the potential of NT-814 in a range of debilitating Women’s Health conditions. We believe NT-814 is one of the few true innovations in Women’s Health in more than two decades and potentially represents a major breakthrough in areas of significant unmet medical need such as PMVMS. Mary has built up an excellent team who have made substantial progress with NT-814 and we’re looking forward to advancing this exciting new product into a Phase 2b programme.”

Professor Richard Anderson, Clinical Adviser, University of Edinburgh, commented, “For many women, menopausal symptoms such as hot flashes are debilitating and long-lasting, and can have a major impact on quality of life. As a potential once daily alternative to HRT without the issues surrounding hormone replacement, NT-814 could bring them considerable relief.”

–ENDS–

For further information, please contact:

Mary Kerr, Managing Director of KaNDy Therapeutics

Tel:  +44 1438 906960
Email: info@kandytherapeutics.com

Notes for editors

About KaNDy Therapeutics
KaNDy Therapeutics is a UK based clinical-stage company focused on optimizing the potential of its unique NK-1,3 receptor antagonist NT-814 in the treatment of common, chronic debilitating female sex-hormone related conditions. NT-814 is in development initially as a non-hormonal therapy to treat moderate to severe post-menopausal vasomotor symptoms (PMVMS)).

PMVMS affect up to 75% of peri-menopausal women. Symptoms last for 1–2 years after menopause in most women, but may continue for up to 10 years or longer in others. Approximately 20% of women will have debilitating symptoms. Hot flashes are the primary reason women seek medical care at menopause. Hot flashes not only disturb women at work and interrupt daily activities, but also have a detrimental effect on sleep. Post-menopausal vasomotor symptoms are experienced by millions of women globally on a daily basis.

The company is led by an experienced management team including Dr Mary Kerr (Managing Director), formerly SVP and Global Franchise lead at GSK and Dr Mike Trower (CSO/COO), formerly VP & Head of the External Drug Discovery Group in the Neurosciences CEDD at GSK and Dr Steve Pawsey (CMO) formerly at Circassia and Vernalis.

KaNDy Therapeutics was spun out of NeRRe Therapeutics in September 2017, and is backed by internationally recognised life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed Advisors. KaNDy Therapeutics is based at Stevenage Bioscience Catalyst. You can find more information about KaNDy Therapeutics at www.kandytherapeutics.com.