New Risk • Jun 25
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended September 2025. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 13% per year for the foreseeable future. Revenue is less than US$1m. Market cap is less than US$10m (€5.85m market cap, or US$6.65m). Minor Risks Latest financial reports are more than 6 months old (reported September 2025 fiscal period end). Currently unprofitable and not forecast to become profitable next year (UK£2.5m net loss next year). Board Change • May 21
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Non-Executive Chair David Alastair Smith was the last independent director to join the board, commencing their role in 2025. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Aankondiging • Jan 27
Theracryf plc Receives Notice of Allowance from the Canadian Patent Office for Its Orexin-1 Addiction Programme TheraCryf plc announced that it has received a Notice of Allowance from the Canadian Patent Office for its Orexin-1 (Ox-1) addiction programme, alongside a positive update on ongoing preclinical development. The Canadian patent represents the final major market to grant for this intellectual property, completing broad protection across the US, Europe, Canada and key Asian territories. The patent provides Composition of Matter, the strongest form of patent cover available, conferring long-term exclusivity and significantly strengthening the commercial and partnering proposition for the programme. The Group also reports continued progress on its Maximum Tolerated Dose (MTD) and Dose Range Finding (DRF) studies, which commenced earlier this month. The MTD have now been successfully completed, with two species dosed up to the regulatory maximum, 1g/kg of the orexin-1 blocker, with no adverse clinical observations reported. This favourable outcome further de-risks the programme and enables progression into repeat-dose DRF studies, the results of which will inform the dosing for the planned 28-day regulatory toxicity studies scheduled in First Quarter and Second Quarter 2026, depending on species. This is a near final step on the path to IND/CTA readiness targeted for 2026. TheraCryf's lead programme, is a novel, best-in-class orexin-1 blocker., being developed as a potential treatment for addiction, including alcohol and other substance use disorders. The programme demonstrates class-leading selectivity and high receptor occupancy, characteristics which are expected to translate into improved tolerability and efficacy. Blocking the orexin-1 pathway has been shown to reduce aberrant substance-seeking behaviour in animal models, and the orexin pathway has attracted strong interest in the pharmaceutical sector. Addiction represents a large and growing global market, with substantial unmet medical need and significant human, social and economic impact, making it an attractive indication for development and commercialisation. Aankondiging • Jan 05
Theracryf Plc Starts 2026 Positive, A Key Milestone on the Path to Clinical Ready for Its Ox-1 Orexin Bladder Potential Treatment for Addiction Disorders TheraCryf plc has started 2026 positively, achieving a key milestone on the path to clinical readiness for its Ox-1 orexin blocker potential treatment for addictive disorders. Process for large-scale manufacturing of drug substance established Scale-up achieved on schedule with a manufacturing yield in excess of target 10.6kg produced to supply critical 28-day regulatory toxicology studies. Dosing in two species has now commenced to identify maximum tolerated dose for 28-day regulatory toxicology study. These studies will begin in first quarter of 2026, depending on species. All studies on schedule to complete third quarter of 2026. Manufacturing scale-up and completion of 28-day toxicology studies were highlighted, during the successful placing in March 2025, as the two key milestones remaining in the Ox-1 programme to achieve clinical readiness. Scale-up of the Ox-1 compound to 10kg has now been achieved on schedule and with a yield in excess of expectations. This drug substance will be used in the 28-day regulatory toxicology projects scheduled to commence, in first quarter and second quarter of 2020 in two species. These studies will provide essential data for the planned regulatory submission later in the year and represent the last major hurdle to achieving that goal. Before starting the 28-day toxicology studies, the Maximum Tolerated Dose and Dose Range Finding studies need to be completed. This work has now started. These studies will identify the 'therapeutic index' of the orexin-1 blocker - that is the range between which the dose is expected to have a therapeutic effect and the highest dose of compound reached before any harmful effects are observed. Ox-1 is TheraCryf's lead asset, an orexin-1 blocker, being developed as a potential treatment for addiction, blocks a pathway in the brain (orexin-1) known to be over-active in individuals with addiction. This group of conditions have significant human and economic impact globally. Blocking the overactivity of this pathway is known to reduce aberrant substance seeking behaviour in animal models. Drugs that can block this pathway have generated significant commercial interest and TheraCryf's orexin-1 blocker is the most selective yet developed, indicating class leading potential. Aankondiging • Nov 24
Theracryf Plc to Report First Half, 2026 Results on Dec 03, 2025 Theracryf Plc announced that they will report first half, 2026 results on Dec 03, 2025 Aankondiging • Nov 05
TheraCryf plc Provides an Update on Key Activity in its Ox-1 Development Programme TheraCryf plc provided an update on key activity in its Ox-1 development programme. 0.5kg scale-up completed, ahead of schedule; Manufacturing of 2kg human grade material initiated; 10kg manufacturing scale-up proceeding to plan. Successful achievement of compound scale-up, from small gram quantities to 0.5kg, is a significant milestone for the Company. This milestone was reached ahead of schedule and with no issues. After formulation to the optimal dosage form, the compound will be used in an in vivo study to identify the 'therapeutic index' this is the range between which the dose is expected to have a therapeutic effect and the highest dose of compound reached before any harmful effects are observed. Data from this study will inform dosing in the key 28-day toxicology studies scheduled to commence in early 2026. The 28-day toxicology studies will be supplied by the 10kg compound scale-up which is currently proceeding to plan and schedule. The Company have also now initiated work through its partner, Pharmaron, to manufacture drug product for human use in the Ph1 healthy volunteer study. This process is conducted under special conditions, referred to as GMP (Good Manufacturing Practice), a regulatory standard to ensure safety and quality in order that the product can be given to people. Data from this activity will form part of the regulatory package required for the clinical trial application. Aankondiging • Jun 17
Theracryf Plc, Annual General Meeting, Jul 09, 2025 Theracryf Plc, Annual General Meeting, Jul 09, 2025. Location: the royal society of medicine, 1 wimpole street, w1g 0ae, london United Kingdom Aankondiging • May 23
Theracryf Plc to Report Fiscal Year 2025 Results on Jun 03, 2025 Theracryf Plc announced that they will report fiscal year 2025 results on Jun 03, 2025 Aankondiging • May 02
Theracryf Plc Announces Appointment of Edward Wardle as Non-Executive Director, Effective 1 May 2025 Theracryf Plc announced the appointment of Edward Wardle to the Board as a Non-Executive Director, effective 1 May 2025. Edward is nominated by Tracarta Ltd, TheraCryf's largest shareholder. He brings board-level experience in strategy, corporate governance, and business development. Edward has founded and led multiple businesses and is currently an investment advisor with Tracarta Ltd. and Northern Standard Ltd, focusing on critical industries and cutting-edge technologies. He also serves as Senior Business Development Executive at Ironveld PLC. Aankondiging • Feb 19
Theracryf Plc has completed a Follow-on Equity Offering in the amount of £4.25 million. Theracryf Plc has completed a Follow-on Equity Offering in the amount of £4.25 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,288,800,000
Price\Range: £0.0025
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 11,200,000
Price\Range: £0.0025
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 400,000,000
Price\Range: £0.0025
Transaction Features: Subsequent Direct Listing Aankondiging • Nov 14
Theracryf Plc to Report First Half, 2025 Results on Nov 28, 2024 Theracryf Plc announced that they will report first half, 2025 results on Nov 28, 2024 Board Change • Nov 08
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 2 non-independent directors. Independent Non-Executive Director Alan Barge was the last independent director to join the board, commencing their role in 2015. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Aankondiging • Nov 05
Theracryf Plc Announces Demise of Sue Foden, Chair TheraCryf plc announced with deep sadness the sudden passing of Dr. Sue Foden, the Company's Chair. Sue was appointed as a non-executive director to TheraCryf plc (then Evgen Pharma plc) in 2015, becoming Chair in September 2023. Over the past nine years, she has been a valuable advisor and support to the leadership team and Company overall. Her passing is a great loss to the Biotech sector in the UK and beyond. The Company will seek an additional non-executive director as soon as practicable. Aankondiging • Jun 22
Theracryf Plc, Annual General Meeting, Jul 18, 2024 Theracryf Plc, Annual General Meeting, Jul 18, 2024. Location: the block 11 lecture theatre, alderley park conference centre, nether alderley, cheshire, sk10 4tg, United Kingdom Aankondiging • May 21
Theracryf Plc to Report Fiscal Year 2024 Results on May 28, 2024 Theracryf Plc announced that they will report fiscal year 2024 results on May 28, 2024 New Risk • May 19
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended September 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (25% average weekly change). Earnings have declined by 7.3% per year over the past 5 years. Shareholders have been substantially diluted in the past year (55% increase in shares outstanding). Market cap is less than US$10m (€3.75m market cap, or US$4.07m). Minor Risks Latest financial reports are more than 6 months old (reported September 2023 fiscal period end). Revenue is less than US$5m (UK£838k revenue, or US$1.1m). New Risk • Apr 09
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 55% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (95% average weekly change). Earnings have declined by 7.3% per year over the past 5 years. Shareholders have been substantially diluted in the past year (55% increase in shares outstanding). Market cap is less than US$10m (€3.99m market cap, or US$4.34m). Minor Risk Revenue is less than US$5m (UK£838k revenue, or US$1.1m). Aankondiging • Apr 04
Evgen Pharma plc has completed a Follow-on Equity Offering in the amount of £0.05167 million. Evgen Pharma plc has completed a Follow-on Equity Offering in the amount of £0.05167 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 5,167,000
Price\Range: £0.01
Transaction Features: Regulation S Aankondiging • Feb 27
Evgen Pharma plc Announces That the Laboratories of Professor Grace Chen, Associate Professor Justin Colacino, and Professor Duxin Sun At the University of Michigan, Usa Have Observed Activity of Sfx-01 in Models of Colon Cancer Evgen Pharma plc announced that the laboratories of Professor Grace Chen, Associate Professor Justin Colacino, and Professor Duxin Sun at the University of Michigan, USA have observed activity of SFX-01 in models of colon cancer. The in vitro and in vivo studies, funded by the USA National Cancer Institute and the University of Michigan will be generating data continuously throughout the project. Aankondiging • Feb 20
Evgen Pharma plc Announces That the Laboratory of Dr Marjolein Geurts, Neuro-Oncologist At the Erasmus University Medical Centre Has Observed Continuing Activity of Sfx-01 in Gbm Cells Evgen Pharma plc announced that the laboratory of Dr Marjolein Geurts, neuro-oncologist at the Erasmus University Medical Centre has observed continuing activity of SFX-01 in GBM cells. The in vitro studies, which are supported by a grant awarded by the KWF Dutch Cancer Society for a €1.1m project, are designed to investigate the activity of SFX-01 in preclinical GBM models. This work is to be followed by administration of SFX-01 to patients with GBM in a clinical Investigator Sponsored Study (ISS). The scientific collaboration, which commenced in October 2023, will run for three years, generating data continuously throughout the period. Aankondiging • Jan 17
Evgen Pharma plc announced that it has received $17.4 million in funding from Stalicla SA Evgen Pharma plc announced a private placement for the gross proceeds of $17,400,000 on January 16, 2024. The transaction included participation from new investor Stalicla SA. Aankondiging • Oct 27
Evgen Pharma plc Announces Erasmus Medical Center Commences Sfx-01 Glioblastoma Studies Evgen Pharma plc and Dr Marjolein Geurts, neuro-oncologist at the Erasmus University Medical Center, announce the formal start of their collaborative project in glioblastoma, supported with a grant awarded by the KWF Dutch Cancer Society. The grant start conditions and documentation have been satisfied and the project formally commenced on 1 October. The studies, which are funded by a grant towards total project costs of approx. EUR 1.1 million awarded by the KWF Dutch cancer Society, will investigate the use of SFX-01 in pre-clinical glioblastoma models, followed by a clinical Investigator Sponsored Study (ISS), aiming to establish the presence of the drug in human brain tumours and engagement with relevant molecular targets in excised tumour tissue. The Erasmus University Medical Center team has also appointed a dedicated, grant funded PhD student, who starts in early November. The project is being carried out in the laboratory and clinic of Dr Marjolein GeURts, neuro-oncologists at Erasmus Medical Center, Cancer Institute, Rotterdam, in the Netherlands and will run for three years, generating data continuously throughout the period. Standard of care for glioblastoma patients is surgery, radiotherapy and chemotherapy, however it is still a disease of significant high unmet need where patient survival rates from diagnosis are between 1 and 3 years and new effective treatment options are sorely needed. Aankondiging • Aug 17
Evgen Pharma plc Announces Final Clinical Study Report from Phase 1B PK/PD Study of New SFX-01 Tablet Formulation Approved Evgen Pharma plc reported the final data from its Phase 1b healthy volunteer study using the Company's new enteric coated tablet formation of lead asset SFX-01. The data are contained in the extensive Clinical Study Report (CSR) which has been approved by the Company and its providers in compliance with good clinical practice (GCP). Highlights · As reported in March 2023, based on the time course seen, sulforaphane was released by the new enteric coated tablet beyond the acid environment of the stomach · No serious adverse events were observed · Total blood levels of sulforaphane (SFN) and SFN-metabolites were confirmed in the micromolar range, where efficacy is seen in vitro · Additional pharmacodynamic exploratory investigation, utilising mRNA sequencing, showed changes in gene expression after dosing with SFX-01 even in healthy volunteers In addition to the biomarkers analysed in the study and contained within the CSR, changes in gene expression were measured by mRNA sequencing on participants' blood, for placebo and SFX-01 treated subjects that received 600mg once daily. The initial analysis identified a large number of significant differentially expressed genes in the SFX-01 treated group, between blood samples taken before the first dose was administered (baseline) and blood samples taken after the first dose timepoint (6 hours after first dose). Further analysis will be undertaken on this large and complex dataset to gain insight into the particular genes identified. Further disease-related mechanistic insight will also be provided from future clinical studies in patients. New Risk • Aug 03
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: €8.94m (US$9.79m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (13% average weekly change). Earnings have declined by 5.9% per year over the past 5 years. Revenue is less than US$1m (UK£442k revenue, or US$562k). Market cap is less than US$10m (€8.94m market cap, or US$9.79m). Minor Risk Currently unprofitable and not forecast to become profitable next year (UK£3.6m net loss next year). Aankondiging • Jun 21
Evgen Pharma plc, Annual General Meeting, Jul 20, 2023 Evgen Pharma plc, Annual General Meeting, Jul 20, 2023, at 13:00 Coordinated Universal Time. Location: the Block 11 Lecture Theatre, Alderley Park, Congleton Road, Nether Alderley, Cheshire, SK10 4TG London United Kingdom New Risk • Jun 08
New major risk - Revenue and earnings growth Earnings have declined by 5.9% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (10% average weekly change). Earnings have declined by 5.9% per year over the past 5 years. Revenue is less than US$1m (UK£442k revenue, or US$549k). Minor Risks Currently unprofitable and not forecast to become profitable next year (UK£3.6m net loss next year). Market cap is less than US$100m (€11.7m market cap, or US$12.5m). Aankondiging • May 27
Evgen Pharma plc to Report Q4, 2023 Results on Jun 07, 2023 Evgen Pharma plc announced that they will report Q4, 2023 results on Jun 07, 2023 Aankondiging • Jan 25
Evgen Pharma plc Announces Update on Study to Investigate Performance of New SFX-01 Tablet Formulation - All Cohorts Dosed Evgen Pharma plc announced that further to its announcement of 16 November 2022, it has completed the dosing of all three cohorts of its placebo-controlled, dose-escalating, randomised Phase I/Ib clinical trial. The study aims toprovide further insight into the pharmacokinetic and pharmacodynamic characteristics of the new enteric coated tablet formulation of the Company's lead asset SFX-01, as well asinvestigating how sulforaphane released from SFX-01 engages with molecular targets of interest. Each cohort comprises 8 healthy volunteers dosed with either SFX-01 or placebo. The dosing has been completed on schedule and analysis of the data is ongoing. The trial is on track to report full data in the second quarter of the year as indicated previously. The new enteric-coated tablet formulation will replace the previous prototype capsule formulation. It releases sulforaphane to a targeted part of the intestine, with the goals of predicable release and minimisation of gastro-intestinal side effects. The new formulation, if it performs as expected, will be suitable for large scale trials and commercial supply. Aankondiging • Dec 02
Evgen Pharma plc to Report First Half, 2023 Results on Dec 08, 2022 Evgen Pharma plc announced that they will report first half, 2023 results on Dec 08, 2022 Board Change • Nov 18
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 2 highly experienced directors. Independent Non-Executive Director Susan Clement-Davies was the last director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Aankondiging • Oct 12
Evgen Pharma plc Announces Clinical Trial Update Evgen Pharma plc announces the start of recruitment for the pharmacokinetic/pharmacodynamic trial in healthy volunteers (HV) and the decision to commence an Investigator Sponsored clinical study (ISS) for the glioblastoma programme. The purpose of the HV study is to examine the performanceof Evgen's new enteric coated tablet formulation of lead asset SFX-01. Following the regulatory approval announced on 3 October 2022, the study is now open for recruitment and the first subjects are expected to enter the trial on schedule this week. The trial is a placebo-controlled, dose-escalating, randomised trial that will assess how SFX-01 in its new form and formulation is absorbed and circulates in the body, and how it engages with target molecules. Results of the HV study are expected during the first half of 2023. In glioblastoma (GBM), Evgen has been consulting widely with world-renowned experts in the treatment of brain cancers with regards to the planned study. These key opinion leaders have advised that further pre-clinical work and an early-stage clinical trial of SFX-01 in patients with GBM should be conducted, to acquire more clarity on sulforaphane entering the brain tumour and its interaction with molecular targets in the tumour tissue of GBM patients. The Company expects that this approach will further de-risk the Phase 2 clinical trial. This preliminary clinical work will be conducted as an Investigator Sponsored Study, led byDr Marjolein Geurts, neuro-oncologist at the Erasmus University Medical Centre, the Netherlands. The Erasmus group has extensive experience in glioblastoma research, with several studies and numerous publications in this field. Evgen has already received positive and supportive regulatory scientific advice from the Dutch Medicines Evaluation Board (MEB), which also states that there are no specific concerns related to the clinical safety profile of SFX-01 based on available data. If the pre-clinical and ISS clinical work is successful, the trial programme is likely to be continued as an Evgen-sponsored trial. Evgen will update on the timing of this trial in due course. Aankondiging • Sep 29
Evgen Pharma plc Receives Regulatory and Ethical Approvals for A Healthy Volunteer, Pharmacokinetic and Pharmacodynamic, Study Toexamine the Performance of the Company's New Enteric Coated Tablet Formulation of Lead Asset SFX-01 Evgen Pharma plc has received regulatory and ethical approvals for a healthy volunteer, pharmacokinetic and pharmacodynamic, study toexamine the performance of the Company's new enteric coated tablet formulation of lead asset SFX-01. As well as safety, the study will investigate how sulforaphane released from SFX-01 engages with key molecular targets that are of interest to Evgen's plans for clinical trials in cancer and other indications. Evgen developed the enteric-coated tablet formulation to replace previously used hand-filled capsules. The new coating is expected to release sulforaphane to a targeted part of the intestine, improving pharmacokinetic properties and minimising gastro-intestinal side effects. The new formulation, if it performs as expected, will be suitable for large scale trials and commercial supply. SFX-01 is the only stabilised sulforaphane suitable for clinical research and eventual approval as a medicine. Aankondiging • Jul 07
Evgen Pharma plc, Annual General Meeting, Jul 21, 2022 Evgen Pharma plc, Annual General Meeting, Jul 21, 2022, at 13:00 Coordinated Universal Time. Location: Alderley Park, Congleton Road, SK10 4TG Nether Alderley Cheshire United Kingdom Aankondiging • Jun 07
Evgen Pharma plc to Report Fiscal Year 2022 Results on Jun 08, 2022 Evgen Pharma plc announced that they will report fiscal year 2022 results on Jun 08, 2022 Board Change • Apr 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. No highly experienced directors. Independent Non-Executive Director Susan Clement-Davies was the last director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Aankondiging • Jan 12
Evgen Pharma plc Announces Progress Discussions with the UK Medicines and Healthcare Products Regulatory Agency and the US Food and Drug Administration Evgen Pharma plc announced that it has progressed discussions with the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA) in relation to two clinical trials set to commence in 2022. The first trial is a Phase I human volunteer study to investigate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of Evgen's new SFX-01 tablet formulation. In addition, the study, which will recruit volunteers randomised to active and placebo arms, will generate data on dose escalation and target pathway engagement. Evgen held a scientific advice meeting with the MHRA in December 2021 at which the draft trial protocol was discussed and the MHRA's written advice, which will reflect the discussions on the data to be submitted in support of approval of the trial, is expected in late January. Board Change • Dec 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. No highly experienced directors. Independent Non-Executive Director Susan Clement-Davies was the last director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Aankondiging • Jul 15
Evgen Pharma plc Announces Early Data for SFX-01 in Leukaemia Cell Lines Evgen Pharma plc announced preclinical data demonstrating that SFX-01 was effective in vitro models of certain blood cancers. The data were generated by Dr. Eleni Louka and Professor Adam Mead of the MRC Weatherall Institute of Molecular Medicine at Oxford University. The study investigated the effect of SFX-01 on cells from tissue donated by patients with Juvenile Myelomonocytic Leukaemia ("JMML"), through the UK Paediatric MDS/JMML study. These patients carry a specific mutation of the PTPN11 gene. The data demonstrated significant reduction of cell proliferation and increased apoptosis (cell death) of JMML stem cells in the presence of SFX-01, compared to normal controls. The study also showed that SFX-01 significantly impacted cell proliferation and increased cytotoxicity in GDM-1 cells, an Acute Myelomonocytic Leukaemia cell line ("AML"). Whilst this is preliminary data from a small sample size, the Company was encouraged to observe a statistically significant effect in reducing cell proliferation and increasing apoptosis. The PTPN11 gene codes for the SHP2 protein (Src homology-2 domain-containing protein tyrosine phosphatase-2). In January, Evgen announced in-vitro and in-vivo data generated by Professor Philip Eaton, Queen Mary University of London, demonstrating that SFX-01 modifies SHP2. Mutations of the PTPN11 gene are among the commonest molecular defects described in JMML patients, indicating that SFX-01 should be investigated further as a potential disease modifying agent in PTPN11-mutated haematological malignancies. The Company is now assessing the optimal preclinical and clinical strategy for a development programme of SFX-01 in blood cancers such as JMML and AML and will update shareholders when this is completed. Aankondiging • Jul 14
Evgen Pharma plc Announces Glioma Orphan Drug Application Submitted to US FDA Evgen Pharma plc announced the filing of an Orphan Drug Designation Request with the US Food and Drug Administration (''FDA'') for use of SFX-01 to treat malignant glioma. Over the last year a strong package of preclinical data has been developed in vitro and in vivo glioblastoma ("GBM") models. In particular, data generated at University L'Aquila showed that with in vivo pre-clinical subcutaneous and orthotopic models (where glioma cells are implanted in brain tissue representing a more disease-relevant model), SFX-01 produced tumour shrinkage and significantly extended survival times. SFX-01 was also found to potentiate (i.e. substantially increase) the therapeutic effect of radiotherapy in these models. Recently the in vitro data from these experiments have been reproduced with very similar results at the University of Auckland using cells generated from freshly extracted patient GBM tissue, rather than the standard GBM cell lines established many decades previously. The Company, with its regulatory advisers has submitted an Orphan Drug application to the FDA. It is expected that, if granted, Orphan Drug ("OD") status would be conferred for SFX-01 in the US this year. OD is usually granted when there are fewer than 200,000 patients with a given disease in the United States and there is a scientific rationale for potential use of the product in that condition. In addition to recognising the relative rareness of a disease and the implications for clinical trials, a successful OD confers separate intellectual property cover to an investigational drug in the form of data protection which is additional to any patent cover in force. Ultimately tax credits are possible on eventual US sales of an approved orphan drug. In parallel, an Investigational New Drug dossier is being prepared for submission to the FDA around the end of the year, to support a Phase II trial in glioma/glioblastoma that is being planned for commencement in the first half of 2022. Aankondiging • Mar 12
Evgen Pharma plc Provides Update on Data Safety Review for STAR COVID-19 Trial Evgen Pharma plc announced that after a review of the first 60 patients enrolled, the Data Safety Monitoring Committee ("DMC") for the STAR COVID-19 ("SFX-01 Treatment for Acute Respiratory infections") trial has concluded that there are no concerns regarding patient safety or data quality that would prevent continuation of the trial. The Phase II/III trial is a double blind, randomised, placebo-controlled study of the Company's lead asset, SFX-01, in patients with acute respiratory distress syndrome (''ARDS''). The trial is co-sponsored by the University of Dundee and NHS Tayside and funded by the UK charity LifeArc. It is investigating whether the Company's lead asset, SFX-01, can reduce the severity, or prevent the onset of, acute respiratory distress syndrome in patients with suspected COVID-19. Patients may be included in the study if they are infected with SARS-CoV-2 or other respiratory infections causing community-acquired pneumonia. Following this positive step, the next event in the trial involves an assessment of safety and futility by the DMC of unblinded data on the first 100 patients treated. In addition to the DMC safety and futility assessment, Dundee University has decided to review the top-level unblinded data in a preliminary assessment of possible efficacy. This may lead to adjustments to the design of the trial for remaining patients, including in-patient numbers, and possibly early termination for either safety, futility or alternatively, strong efficacy. It is expected that this initial data will be available during Second Quarter of the calendar year 2021. Completion of recruitment to the STAR trial is anticipated at the end of 2021/early 2022, assuming there are no substantial changes in the total patients to be recruited. Aankondiging • Feb 18
Evgen Pharma plc Updates on Patient Recruitment Evgen Pharma plc announced that as of 16 February, a total of 102 patients had been recruited and randomised to the STAR trial ("SFX-01 Treatment for Acute Respiratory infections"). This Phase II/III trial is a randomised, placebo-controlled trial, sponsored by the University of Dundee and funded by the UK charity LifeArc. It is investigating whether the company's lead asset, SFX-01, can reduce the severity, or prevent the onset of, acute respiratory distress syndrome ("ARDS") in patients with suspected COVID-19. Patients may be included in the study if they are infected with SARS-CoV-2 or another respiratory infections causing community-acquired pneumonia. The trial design includes an assessment of safety and futility by a Data Safety and Monitoring Board ("DSMB") who will review unblinded data on the first 100 patients treated. In addition to the DSMB safety and futility assessment, Dundee University ("the Sponsor") has decided to review the top-level unblinded data in a preliminary assessment of possible efficacy. This may lead to adjustments to the design of the trial for remaining patients, including in patient numbers, and possibly early termination for either safety, futility or alternatively, strong efficacy. It is expected that this initial data will be available during the second quarter of calendar 2021. The Sponsor has also requested that the DSMB review data from the first 60 patients solely for safety and this process will be starting shortly. The outcome of this is expected to be available in early Second Quarter 2021. Completion of recruitment to the STAR trial is anticipated at the end of 2021/Q1 2022, assuming there are no substantial changes in the total patients to be recruited. Aankondiging • Feb 03
Evgen Pharma plc, Annual General Meeting, Mar 03, 2021 Evgen Pharma plc, Annual General Meeting, Mar 03, 2021, at 10:00 Coordinated Universal Time. Aankondiging • Jul 17
Evgen Pharma plc to Report Fiscal Year 2020 Results on Jun 15, 2020 Evgen Pharma plc announced that they will report fiscal year 2020 results on Jun 15, 2020