MANCHESTER, United Kingdom – June 18, 2025 – 51������ Ltd, a clinical-stage biopharmaceutical company developing olorofim, a novel therapy to treat life-threatening rare fungal infections with high unmet medical need, today announced the publication of the full data set from its Phase 2b open-label study.¹ The study evaluated oral olorofim in patients with invasive fungal diseases (IFDs) who had limited or no treatment options. The results, now published in The Lancet Infectious Diseases (“The Lancet ID”), highlight olorofim’s encouraging therapeutic responses across a broad range of difficult-to-treat fungal pathogens and expands on data presented at the Trends in Medical Mycology (TIMM) meeting in October 2023.

“The publication of our data in The Lancet ID validates our efforts to develop olorofim as a treatment for serious invasive fungal  diseases, including those resistant or refractory to all approved antifungals,” said John H. Rex, MD, Chief Medical Officer of 51������. “Olorofim, the first in a new class of antifungals, has a novel mechanism of action and shows potential in addressing rare fungal infections in well-defined and high need populations. We are committed to developing olorofim for patients who have exhausted treatment options and are in need of a new effective therapy.”

Johan Maertens, MD, PhD, Professor of Hematology at University Hospitals Leuven (Belgium), the study’s Principal Investigator, added, “There is a critical unmet need for novel antifungal therapies as lifesaving interventions. Cancer treatments and organ transplants, combined with an aging population, have led to a rise in individuals at risk of invasive fungal infections—many of which are increasingly difficult to treat. The data published in The Lancet ID show successful global and clinical responses in patients with both brief and lengthy periods from diagnosis to initiation of olorofim treatment, with infections due to highly resistant organisms and those in difficult-to-treat sites such as brain and bone. We were also pleased to see the accompanying editorial by Paccoud and Lanternier² which concludes by noting that ‘these important findings underscore olorofim’s clinical value in addressing unmet needs in the management of difficult-to-treat fungal infections across a diverse patient population.’”

The Phase 2b study (Study 32; ) enrolled 202 patients with proven or probable IFDs, including infections caused by Aspergillus spp. (including azole-resistant strains), Lomentospora prolificans, Scedosporium spp., Coccidioides spp., and other rare moulds. Patients were treated with oral olorofim and evaluated for treatment response over 84 days with extended therapy available as needed beyond Day 84.

Patient Demographics and Dosing:

• Phase 2b open-label study of oral olorofim in 203 patients with limited treatment options for IFD.
  • 202 patients were confirmed by the Data Review Committed to have IFDs defined as proven or probable pulmonary invasive aspergillosis (IA) per EORTC-MSG³ criteria and efficacy analysis was done on those patients that met the modified ITT (mITT) criteria.
  • Causative organisms included Aspergillus species (101, including 22 cases with azole-resistant strains), Lomentospora prolificans (26), Scedosporium spp. (22), Coccidioides spp. (41), and other fungi (12).
• Treatment was given for up to 84 days +/- 6 days with extended therapy permitted when clinically indicated.
  • The mean dosing duration was 73 days in the 203 patients dosed in the main phase of the study and 361 days for 114 subjects who received extended treatment.
  • During the main treatment phase, 61.9% of patients received olorofim entirely as monotherapy and 70.8% received ≤ 7 days of concomitant administration of a potentially effective second antifungal agent.

Efficacy and Safety Results:

• Olorofim demonstrated an acceptable benefit-risk profile.
  • The rate of successful global response for the entire mITT population at day 42 (primary endpoint), as determined by an independent DRC applying the MSG/EORTC criteria⁴, was 28.7%, and 27.2% at day 84.
  • When considering stable disease as a successful global response, the rates of successful outcome for the entire mITT population at day 42 and day 84 rose to 75.2% and 63.4%, respectively.
  • Successful clinical response was 59.9% and 54.0% at day 42 and day 84, respectively.
  • Clinical response was similar across all levels of immunosuppression
• All-cause mortality at day 42 and day 84 was 11.9% and 16.3%, respectively.
• Olorofim was generally well-tolerated, even with dosing >2 year in extension therapy.
  • Changes in liver biochemistry that were deemed at least possibly due to olorofim were seen in 9.9% of study subjects overall (main phase + extended therapy). All events were successfully managed by dose modifications (pausing or reducing, including successful restarting).
  • Changes in the liver biochemistry led to permanent discontinuation in 3%.
  • Gastrointestinal intolerance to olorofim, generally self-limiting, was noted in 9.9%.

51������ and Shionogi & Co., Ltd. are collaborating to develop and commercialise olorofim, bringing the novel antifungal therapy to patients with invasive fungal infections. Shionogi has commercial responsibility for olorofim in Europe and Asia Pacific and 51������ has commercial responsibility for olorofim in North America, and rest of the world. 51������ and Shionogi are currently enrolling patients with invasive aspergillosis in a global Phase 3 study (OASIS) to compare treatment with olorofim versus AmBisome® followed by standard of care ().

About Study 32 

Study 32 was a multicenter, open-label, Phase 2b study to evaluate the safety and efficacy of olorofim (formerly F901318) in patients ≥ 18 years of age with probable pulmonary invasive aspergillosis or proven invasive fungal infections due to Lomentospora prolificans, Scedosporium spp., Aspergillus spp., and other resistant fungi with limited or no treatment options. It enrolled patients between June 2018 and September 2022.

Enrolled patients received an initial loading dose of 150 mg BID (twice a day) of oral olorofim on day one, and subsequent oral doses of 90 mg BID for up to 90 days. Patients were followed for another four weeks after the end of treatment, while some received extended therapy for as long as thought clinically beneficial. For more information on Study 32, visit ClinicalTrials.gov (). These data enable continued clinical development and support future regulatory and commercial planning.

About Olorofim

Olorofim (formerly, F901318) is 51������’s leading candidate from the orotomide class and is currently in a global Phase 3 trial (“OASIS”) (). 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. Olorofim is an investigational therapy and has not been approved by any regulatory authorities.

About 51������

51������ is a clinical-stage biopharmaceutical 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. 51������ has discovered and developed a completely new class of antifungal agents called the orotomides, which selectively target a key enzyme in the pyrimidine biosynthesis pathway, a novel mechanism of action that is distinct from currently marketed antifungal agents. This mechanism provides the orotomides with fungicidal activity against a broad range of rare and resistant fungal mould infections. For more information, please visit: www.f2g.com

About Shionogi & Co. Ltd.

Shionogi & Co., Ltd. is a 147-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is 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 currently markets products in several therapeutic areas including anti-infectives, pain, CNS disorders, cardiovascular diseases and gastroenterology. Shionogi’s research and development currently target two therapeutic areas: infectious diseases, and pain/CNS disorders.

For more information on Shionogi & Co., Ltd., please visit  .

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:
Jonathan Pappas
LifeSci Communications
+1 646 970 4688
JPappas@lifescicomms.com

SHIONOGI Website Inquiry Form .
EU Media: pressoffice:shionogi.eu

¹ Maertens JA, Thompson GR, Spec A, Donovan FM, Hammond SP, Bruns AH, et al. Olorofim for the treatment of invasive fungal diseases in patients lacking suitable therapeutic options. Lancet Infectious Disease. 2025; DOI: 10.1016/S1473-3099(25)00237-3  

² Paccoud O, Lanternier F. Olorofim: addressing unmet needs of patients with difficult-to-treat fungal infections. Lancet Infectious Disease. 2025; DOI: 10.1016/S1473-3099(25)00237-3

³ De Pauw B, Walsh TJ, Donnelly JP, Stevens DA, Edwards JE, Calandra T, et al. Revised definitions of invasive fungal disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. Clinical Infectious Diseases. 2008;46(12):1813-21.

⁴ Segal BH, Herbrecht R, Stevens DA, Ostrosky-Zeichner L, et al. Defining responses to therapy and study outcomes in clinical trials of invasive fungal diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer consensus criteria. Clinical Infectious Diseases. 2008 Sep 1;47(5):674-83. doi: 10.1086/590566. PMID: 18637757; PMCID: PMC2671230.

MANCHESTER, United Kingdom, September 12, 2024 – 51������ 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 announced a $100 million financing round. The financing is being led by new investor AMR Action Fund and co-led by ICG, with strong participation from existing investors Novo Holdings, Advent Life Sciences, Sofinnova Partners, Forbion, Blue Owl Healthcare Opportunities, Morningside Ventures, Brace Pharmaceuticals, and Merifin Capital. The proceeds from the financing will enable 51������ to complete late-stage development, seek regulatory approval, and prepare for commercialization in the US of olorofim, a novel oral antifungal therapy to treat invasive aspergillosis (IA) and other invasive fungal infections. Henry Skinner, Ph.D., Chief Executive Officer of AMR Action Fund and Toby Sykes Ph.D., Managing Director of ICG Life Sciences, will join the 51������ Board of Directors. The financing is subject to customary Foreign Direct Investment (FDI) clearance by local authorities in Austria, where 51������ has a 100%-owned subsidiary, and expected to close in the fourth quarter of 2024.

Olorofim is the first orotomide antifungal, an entirely novel class of antifungal agents 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 novel 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.

Francesco Maria Lavino, Chief Executive Officer of 51������, said: “We are delighted to attract this additional capital investment into 51������, and we are thrilled to be working with the AMR Action Fund, an important player in the antimicrobial space, and ICG, a leading alternative asset manager. The addition of Dr. Skinner and Dr. Sykes to our Board will be invaluable as we move to our next stage of growth. This is a pivotal period for the Company as we conclude the final stages of development and preparation for commercialization of olorofim in the US and elsewhere. If approved, olorofim is expected to be the first of a new class of antifungal agents with a novel, differentiated mechanism of action and will address genuine unmet needs in conditions with high morbidity and mortality.”

Dr. Skinner commented: “Fungal infections are a growing threat to patients around the world and have a disproportionate impact on vulnerable populations, yet there has been a paucity of innovation in the field of antifungals. For decades, clinicians have relied on a handful of antifungal classes, with few mechanisms of action and significant limitations due to spectrum of activity, drug toxicities, or drug-drug interactions. These therapies are increasingly failing in patients. We are thrilled to support 51������’s team as they develop this urgently needed therapy and seek regulatory approval.”

Dr. Sykes commented: “Fungal pathogens continue to emerge and spread. This evolving threat underscores an urgent unmet medical need for advanced antifungal treatments. By investing in the development of novel antifungal drug candidates like olorofim, we hope to address this critical gap, ultimately making a meaningful and sustainable social impact on patients, their caregivers, and healthcare systems.”

About 51������
51������ is a clinical-stage biopharmaceutical 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. 51������ 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: 

About olorofim
Olorofim (formerly, F901318) is 51������’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. 51������ has initiated a global Phase 3 trial (“OASIS”) to compare treatment with olorofim versus liposomal amphotericin B followed by standard of care (SOC) in patients with invasive fungal disease caused by proven Invasive Aspergillus or probable lower respiratory tract disease by 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, do not cause disease. 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, especially in immunocompromised hosts. Invasive aspergillosis is a rare disease that can occur in over 10% of some high-risk immunosuppressed populations with mortality exceeding 80%.

Media Contact
Kristin Politi, Ph.D.
LifeSci Communications
kpoliti@lifescicomms.com
646-876-4783

MANCHESTER, United Kingdom, June 15, 2023 – 51������ Ltd. today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for olorofim, an investigational antifungal, for the treatment of invasive fungal infections in patients who have limited or no treatment options. 

According to the CRL, FDA was not able to approve olorofim at this time, requesting additional data and analyses. The additional information requires time and resources that extend beyond the current review period. The FDA encouraged the company to work with the agency to plan for the new analyses and develop the NDA package.

The initial NDA included data from the first 100 patients enrolled in the then-ongoing Phase 2b single-arm, open-label study (Study 32, NCT03583164). The NDA was accepted for review by the FDA with a PDUFA target action date set for June 17, 2023. Study 32 has now completed enrollment with a total of 203 patients, and the full data set is planned to be submitted as part of the revised NDA package.

“While 51������ is disappointed with this outcome, we remain optimistic about olorofim’s potential to address an unmet need for patients with invasive fungal infections who have exhausted their treatment alternatives,” said Francesco Maria Lavino, chief executive officer of 51������. “We are assessing the details of the CRL and we plan to meet with the FDA to discuss it further, but we are confident that we can identify a regulatory path forward in the US.”

In parallel, 51������ continues to expand olorofim’s clinical development program, and along with its partner Shionogi & Co., Ltd. is enrolling patients with proven or probable invasive aspergillosis in a global Phase 3 trial (“OASIS”) to compare treatment with olorofim versus AmBisome^® followed by standard of care (). 51������ has commercial responsibility for olorofim in North America, and Shionogi has commercial responsibility for olorofim in Europe and Asia Pacific.

About Olorofim
Olorofim (formerly, F901318) is 51������’s leading candidate from the orotomide class. A Phase 2b single-arm 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 has recently completed enrollment. To expand on the studied patient population, 51������ 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 (). 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 �����DZ�ܱ��������DZ��������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 �����DZ�ܱ��������DZ��������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. 

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

About 51������
51������ 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. 51������ 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: 

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

The new 51������ office space within the flexible ARRIVE workspace in MediaCity’s Blue tower allows the company room for future expansion, and access to the White and Tomorrow facilities including additional space for hosting events for its entire UK workforce and partners.

Stephen Kirk, Head of Property for MediaCity, said, “51������’s work in the treatment of life threatening fungal infections is groundbreaking and as a world class tech, digital and innovation hub which attracts many dynamic sectors from fintech and gaming to medical science we’re delighted 51������ has based its UK headquarters here.”

Mike Birch, Chief Operating Officer of 51������, added, “MediaCity was an easy choice to make for our new UK headquarters because of its proximity to our research facility in Eccles and the sense of community that has been created amongst the companies that call this place home. We look forward to being an active member of the MediaCity community.”

Manchester is a big part of 51������’s history – its major scientific discoveries around the new class of antifungals called, orotomides, were made in a research lab less than a mile away from MediaCity. The company was established in Manchester leveraging the teams’ fungal genetics expertise to discover cellular targets to use in drug discovery. For twenty years the team has been on a journey to unlock the potential of its science and is now on the verge of bringing an entirely new class of systemic antifungal agents to treat patients with life-threatening systemic fungal infections.

About MediaCity
MediaCity is a waterside community that’s part of Salford Quays in Salford, Greater Manchester. It’s home to some of the world’s most exciting creative, tech and media brands, from BBC North and ITV to Ericsson, The Hut Group Group, Kellogg’s and over 250 creative and tech businesses. Three education establishments are based there, including the University of Salford’s dedicated MediaCity campus, while at its heart is HOST, the Home of Skills & Technology, which supports innovators in data, analytics, cybersecurity, AI, gaming and immersive technologies. Alongside a growing roster of local, independent food, drink and retail operators is a dedicated shopping centre, parks and public spaces, and one of the UK’s most visited arts centres, The Lowry. Sustainability is core to MediaCity’s future: home to the UK’s largest cluster of net zero carbon buildings, it has two dedicated Metrolink tram stops, while 100% of its energy comes from renewable sources. It is also a popular residential neighbourhood, with MediaCity as a whole set to double in size within the next decade. 

MediaCity is a joint venture between Peel L&P and Landsec. Together, their inclusive and collaborative approach to the development of MediaCity will ensure that it grows into a community united by creativity, and a place of play, imagination, and innovation. 

About 51������
51������ 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. 51������ 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: 

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

The Investment Deal of the Year award, sponsored by QIAGEN, is in recognition of 51������’s strategic collaboration with Shionogi Co., Ltd. to develop and commercialize a new class of antifungal drugs for invasive fungal infections in Europe and Asia, bringing the drug to patients 51������ alone would not have reached. The deal terms between 51������ Ltd., and Shionogi & Co. Ltd were notably above benchmarks for the antifungal space.

“We are honored to be recognized and celebrated by our peers with the prestigious award from Bionow. It is a testament to the hard work and commitment of our team to advance a novel antifungal therapy for patients with invasive fungal infections who have exhausted their treatment options,” said Francesco Maria Lavino, Chief Executive Officer of 51������. “We are grateful for the support of our investors, partners, and collaborators, particularly our colleagues at Shionogi who continue to believe in the potential of our transformational science and look forward to bringing a new antifungal to global markets.”

About Bionow Awards
The prestigious Bionow Awards is a highlight of the life sciences calendar and celebrates the achievements of the sector, showcasing the very best in the industry.

About 51������
51������ 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. 51������ 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:

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

Francesco Maria Lavino will discuss the Company’s lead antifungal drug candidate, olorofim, a first-in-class, oral small molecule with a novel, differentiated mechanism of action for the treatment of invasive fungal infections. Last month, the U.S. Food and Drug Administration (FDA) accepted for filing a New Drug Application (NDA) for olorofim for the treatment of invasive fungal infections in patients who have limited or no treatment options with a PDUFA date set for June 17, 2023.

Details for the presentation are as follows:

Date: Wednesday, January 11, 2023

Time: 10:00 a.m. PT

Location: Yosemite-C, Ballroom Level, Hilton San Francisco Union Square

About Olorofim

Olorofim (formerly, F901318) is 51������’s leading candidate from the orotomide class and the company recently completed enrollment of an ongoing Phase 2b open-label study in patients who have limited treatment options for difficult-to-treat, invasive, rare fungal mold infections including azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, invasive Scopulariopsis, and other rare mold infections (). Initial data were presented at ID Week in Washington DC in October 2022 and the full data will be presented at a global conference later this year. 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 () is currently enrolling. 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 51������

51������ 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. 51������ 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: 

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

PRINCETON, New Jersey, December 19, 2022 – 51������ 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.

51������ 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, ).

“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 51������. “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 51������, 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 51������’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. 51������ 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 (). 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 51������
51������ 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. 51������ 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: 

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

MANCHESTER, United Kingdom, October 21, 2022 – 51������ 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 announced at IDWeek 2022 positive data from the first 100 patients who completed study treatment in its ongoing Phase 2b open-label study (Study 32,��) of oral olorofim as a treatment for invasive fungal infections. 

“Invasive fungal infections are a major problem, particularly among immunosuppressed patients. Patients may be refractory or unable to tolerate existing antifungal treatments and, in some cases, fungi are resistant to available therapies, underscoring the need for new and effective antifungal treatments. Approximately 75% of patients in this analysis had moderate to high levels of immunosuppression, with about half suffering from fungal infections due to Aspergillus. Other causes of infection included filamentous fungi such as Lomentospora prolificans and dimorphic fungi such as Coccidioides species (which causes Valley Fever),” said John H. Rex, MD, chief medical officer of 51������. “We are encouraged by these results because they demonstrate a positive risk-benefit profile for olorofim as an oral therapeutic option for the treatment of serious or life-threatening invasive fungal infections in patients who have limited or no treatment options.”

Key findings:

• Data came from 100 patients with proven invasive fungal infection or probable pulmonary invasive aspergillosis (IA). Causative organisms included Aspergillus spp., Lomentospora prolificans, Scedosporium spp., Scopulariopsis spp., Coccidioides spp., and other olorofim-susceptible fungi. Patients had limited alternative treatment options; reasons for this included failure of available therapy, resistance of infecting isolate to all licensed agents, intolerance to available therapy, inability to manage drug-drug interactions, and/or inability to produce therapeutic drug levels.
• The median dosing duration in the main phase of the study was 84 days; patients (n=42) who entered the extension phase of the study were dosed for a median of 308 days.
• Olorofim demonstrated a positive risk-benefit profile 
  • At day 42, 44% of patients had a complete or partial response to treatment
  • With stable response rate included, the overall response rate was 69%
• All-cause mortality (ACM) at day 42 and day 84 were 15% and 20%, respectively. 
• Olorofim was generally well tolerated
  • The only significant serious adverse event was drug-induced liver injury (DILI) which was thought to be possibly related to olorofim in 8 (8%) study patients; only 2 (2%) patients required discontinuation of olorofim due to DILI.
  • Other non-serious adverse events observed included diarrhea, nausea, and vomiting.

“Mortality remains unacceptably high in patients with severe and life-threatening fungal infections being treated with currently available therapies. Developing new antifungals, like olorofim, that can meet this clear unmet need is a priority. With its novel mechanism of action, olorofim has shown activity against a wide range of fungi, including some for which there is currently no approved treatment. These data provide evidence that we are on the path to meeting this need in patients currently with limited or no treatment options,” added Johan Maertens, MD, PhD, Professor of Hematology at University Hospitals Leuven (Belgium) and primary author for Study 32.

Olorofim is the only antifungal medication to be awarded Breakthrough Therapy Designation by the US Food and Drug Administration (FDA). Olorofim works through a novel mechanism of action, different from existing classes of antifungals, exerting fungicidal activity 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, Scopulariopsis), and dimorphic fungi (e.g., Coccidioides spp.). 

About Study 32 

Study 32 is an ongoing multicenter, open-label, Phase 2b study to evaluate the safety and efficacy of olorofim (formerly F901318) in patients ≥ 18 years of age with probable pulmonary invasive aspergillosis or proven invasive fungal infections due to Lomentospora prolificans, Scedosporium spp., Aspergillus spp., and other resistant fungi with limited or no treatment options. 

Enrolled patients receive an initial loading dose of 150 mg BID (twice a day) of oral olorofim on day one, and subsequent oral doses of 90 mg BID for up to 90 days. Patients are followed for another four weeks after end of treatment, while some receive extended therapy for as long as thought useful. For more information on Study 32, visit ClinicalTrials.gov ().

About Olorofim

Olorofim (formerly, F901318) is 51������’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. 51������ has initiated a global Phase 3 trial (“OASIS”) 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 Scopulariopsisspecies, 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 Scopulariopsisspecies” and “treatment of Central Nervous System (CNS) coccidioidomycosis refractory or otherwise unable to be treated with standard of care therapy.” The scientific information discussed in this news release related to olorofim is preliminary and investigative. Olorofim is not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding its safety or efficacy. 

About 51������

51������ 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. 51������ 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: 

Media Contact

Kara Stephens-Weaver
LifeSci Communications
407-765-1185
KStephens-Weaver@LifeSciComms.com

Oral presentations will include the first presentation of efficacy and safety data from the Phase 2B trial of ofolorofim (ClinicalTrials.gov Identifier: NCT03583164) the company’s novel orotomide antifungal, active against Aspergillus (including azole-resistant and cryptic species), resistant molds (e.g., Lomentospora prolificans, Scopulariopsis) and dimorphic fungi (e.g., Coccidioides). The Company will also present posters on pharmacokinetic data from Phase 1 and Phase 2B studies of olorofim antifungal therapy.

Oral Presentation Details:

Presentation Title: Olorofim for treatment of invasive fungal infections (IFI) due to moulds in patients with limited or no treatment options: Interim results from a Phase 2b open-label study (NCT03583164, Study 32)
Presentation Number: 754
Session: Medical Mycology
Presenting Author: Johan A. Maertens, M.D., Ph.D., Professor of Internal Medicine and Hematology, Acute Leukemia and Transplantation Unit at University Hospitals Leuven; Department of Microbiology, Immunology and Transplantation at KULeuven, Leuven, Belgium
Presentation Date and Time: Thursday October 20, 2022; 2:30-2:45 PM ET

Presentation Title: Olorofim for the treatment of invasive mould infections in patients with limited or no treatment options: Comparison of interim results from a Phase 2B open-label study with outcomes in historical control populations (NCT03583164, FORMULA-OLS, Study 32)
Presentation Number: 870
Session: Antifungal Clinical Trials & PK/PD Studies
Presenting Author: Johan A. Maertens, M.D., Ph.D., Professor of Internal Medicine and Hematology, Acute Leukemia and Transplantation Unit at University Hospitals Leuven; Department of Microbiology, Immunology and Transplantation at KULeuven, Leuven, Belgium
Presentation Date and Time: Friday October 21, 2022; 11:00-11:15 AM ET

Presentation Title: Olorofim – the first of a novel class of antifungals, the orotomides; 51������ Inc.
Presentation Number: 1618
Session: New Antimicrobials and ID Diagnostics in the Pipeline – Fungal
Presenting Author: John H. Rex, M.D., Chief Medical Officer, 51������
Presentation Date and Time: Saturday October 22, 2022; 8:20-8:30 AM ET

Poster Presentation Details:

Presentation Title: An Open-Label Study in Healthy Volunteers to Determine the Absolute Bioavailability of the Effect of Food and Dosing by Nasogastric Tube upon the Pharmacokinetics of a Single Oral Dose of Olorofim (OLO)
Poster Number: 594
Session: PK/PD Studies
Presenting Author: Karen Cornelissen, PhD, Senior Director, Early Clinical Development, 51������

Presentation Title: Olorofim (OLO) for treatment of invasive mould infections in patients with limited or no treatment options: PK data from a Phase 2b open-label study (NCT03583164, Study 32)
Poster Number: 595
Session: PK/PD Studies
Presenting Author: Karen Cornelissen, PhD, Senior Director, Early Clinical Development, 51������

About 51������
51������ 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. 51������ 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: 

About Olorofim
Olorofim (formerly, F901318) is 51������’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. 51������ 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%.

Kara Stephens-Weaver
LifeSci Communications
407-765-1185
KStephens-Weaver@LifeSciComms.com

MANCHESTER, UK, 4 August 2022 – 51������ 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 51������ 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 51������ 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 51������’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 51������, said: “We are delighted to attract this additional capital from such high caliber late-stage investors to 51������, 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 51������. 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, 51������ 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, 51������ 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:

51������ 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: 51������@optimumcomms.com
Tel: +44 (0) 203 882 9621

Notes to Editors

About 51������
51������ 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. 51������ 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:

About olorofim
Olorofim (formerly, F901318) is 51������’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. 51������ 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:

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: