Anuncio • May 22
ValiRx plc has completed a Follow-on Equity Offering in the amount of £0.15 million. ValiRx plc has completed a Follow-on Equity Offering in the amount of £0.15 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 75,000,000
Price\Range: £0.002 Board Change • May 20
Less than half of directors are independent There are 4 new directors who have joined the board in the last 3 years. Of these new board members, 1 was an independent director. The company's board is composed of: 4 new directors. 7 experienced directors. 1 highly experienced director. 1 independent director (3 non-independent directors). CFO, Company Secretary & Executive Director James Desler is the most experienced director on the board, commencing their role in 2006. Independent Non-Executive Chairman Martin Gouldstone was the last independent director to join the board, commencing their role in 2024. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of experienced directors. Anuncio • Nov 20
ValiRx plc has completed a Follow-on Equity Offering in the amount of £0.74 million. ValiRx plc has completed a Follow-on Equity Offering in the amount of £0.74 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 112,304,600
Price\Range: £0.0025
Security Features: Attached Warrants
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 183,695,400
Price\Range: £0.0025
Security Features: Attached Warrants
Transaction Features: Subsequent Direct Listing Anuncio • Nov 04
ValiRx plc has completed a Follow-on Equity Offering in the amount of £0.151806 million. ValiRx plc has completed a Follow-on Equity Offering in the amount of £0.151806 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 60,722,400
Price\Range: £0.0025
Security Features: Attached Warrants Anuncio • Oct 30
ValiRx plc has filed a Follow-on Equity Offering in the amount of £0.74 million. ValiRx plc has filed a Follow-on Equity Offering in the amount of £0.74 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 112,304,600
Price\Range: £0.0025
Security Features: Attached Warrants
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 183,695,400
Price\Range: £0.0025
Security Features: Attached Warrants
Transaction Features: Subsequent Direct Listing Anuncio • Jun 07
ValiRx plc, Annual General Meeting, Jun 30, 2025 ValiRx plc, Annual General Meeting, Jun 30, 2025. Location: the offices of fieldfisher llp, riverbank house, 2 swan lane, ec4r 3tt, london United Kingdom Anuncio • Mar 27
ValiRx plc Announces Directorate Changes and Formation of New Advisory Board ValiRx Plc announced the resignation of Adrian de Courcey from its Board of Directors and that Cathy Tralau-Stewart has agreed with the Board to transition to a role as Non-Executive Director of the Company. The Company also announced the formation of its new Advisory Board which will replace its current Scientific Advisory Board. Cathy Tralau-Stewart, Chief Scientific Officer and Director of the Company, has agreed with the Board to transition to a role as Non-Executive Director of the Company with immediate effect. Cathy will be appointed as Chair of the new Advisory Board set up to deliver Scientific, Commercial and Strategic Advice to the Company. Adrian de Courcey has informed the Board that he has resigned as Non-Executive Director of the Company with immediate effect, to focus on other opportunities. During her tenure as the fractional CSO, Cathy has been instrumental in developing ValiRx's pipeline strategy, identifying, reviewing and advising on a series of Evaluation and In-licensing options. Cathy brings a wealth of experience in drug development as well as industry contacts and recognition which ValiRx wishes to retain. During Adrian's tenure as a ValiRx Non-Executive Director, he has helped the Company navigate a major strategic and organisational overhaul with the new management team to achieve significant operational efficiencies and reduce cash burn. These changes at the Board level form part of implementing a significant restructure and reduction in headcount across the Company As part of the restructure, the Company has hired a new, full time, Director of Research (non-board role), Michelle Barnard, who brings over 10 years' experience as a Senior Scientist specialising in Oncology Biology at Cancer Research Horizons and in Drug Discovery at the University of Graz prior. The Inaphaea team will also be supported by a specialist technician. These changes are expected to reduce annual costs by approximately £200,000. New Advisory Board: ValiRx has also assembled a range of experts to establish its new Advisory Board ("AB"). The initial members of the AB, in addition to Cathy Tralau-Stewart as chair, will comprise: Dr Heather Wilson Robles, a clinical oncologist and former President of the Veterinary Cancer Society, specialising in veterinary medicine is based at United Veterinary Care and Ethos Discovery based in Washington DC US. Dr Simon Wheeler, a former member of Novartis Ventures tasked with finding Veterinary medicine investments and now an Independent Animal Health and Veterinary Consultant. The AB brings a combination of scientific and commercial expertise as well as contacts within the industry. The AB also brings a balance of human and veterinary medicine expertise as the company explore opportunities to leverage the preclinical data for earlier access to the veterinary market in addition to the primary focus on the human market. Anuncio • Dec 10
ValiRx plc has completed a Follow-on Equity Offering in the amount of £1.573 million. ValiRx plc has completed a Follow-on Equity Offering in the amount of £1.573 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 182,000,000
Price\Range: £0.0065
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 21,538,461
Price\Range: £0.0065
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 35,384,615
Price\Range: £0.0065
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 3,076,923
Price\Range: £0.0065
Transaction Features: Subsequent Direct Listing Board Change • Oct 23
Less than half of directors are independent There are 4 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 4 new directors. 7 experienced directors. 1 highly experienced director. 2 independent directors (3 non-independent directors). CFO, Company Secretary & Executive Director James Desler is the most experienced director on the board, commencing their role in 2006. Independent Non-Executive Chairman Martin Gouldstone was the last independent director to join the board, commencing their role in 2024. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of experienced directors. Anuncio • Oct 18
ValiRx plc Announces Resignation of Martin Lampshire as A Non-Executive Director ValiRx plc announced the resignation of Martin Lampshire as a Non-Executive Director of the Company, effective from 18 October 2024. Martin has decided to step down from the Board of ValiRx to concentrate on his other commitments. During Martin's four year tenure as a ValiRx Non-Executive Director, he has made significant contributions to the development of the strategy and helped the Company build relationships with various City stakeholders. Anuncio • Jul 25
ValiRx plc Announces Board Changes ValiRx plc announced that Martin Gouldstone, a current Independent Non-Executive Director of the Company, has been appointed Independent Non-Executive Chairman with immediate effect. In addition, the Company announces that Cathy Tralau-Stewart has been appointed to the Board as Executive Director with immediate effect and Dr. Mark Eccleston is proposed to the join the Board as Chief Executive Officer subject to standard regulatory due diligence. Dr. Mark Eccleston: Mark has worked as a scientific consultant and served on both the Commercial and Scientific Advisory Boards of ValiRx and Inaphaea gaining comprehensive knowledge of the Company's development programmes. With over 30 years' experience working in translation science in both drug and biomarker development, Mark is a former BBSRC Enterprise fellow and holds an MBA (Entrepreneurship). He is an inventor of 26 published patents ranging from peptide and CAR-T cell therapies to nucleosome enrichment as well as biodegradable chewing gum. Mark is the Managing Director of OncoLytika Ltd, a UK based technology consultancy company with a successful track record of securing grant funding (close to €3 million in Eurostar funding), strategic business development and client project management. He is also a scientific founder of several companies, including Volition, US listed biomarker company established as a spin out from ValiRx which reached a peak valuation of over $250 million. Mark currently serves as an independent scientific advisor supporting Nu.Q Discover services and sits on Volition's Scientific Advisory Board as well as being a shareholder. In addition to his commercial activities, Mark has supervised multiple industry funded PhD and Masters students at various universities, including the Open University, Greenwich University and DKFZ in Germany. He also serves as an external advisor to the Open University, contributing to modules focused on employability of biosciences graduates and employer expectations from graduates in terms of bioinformatics training. Further to the announcement on 19 March 2024, Suzanne Dilly will remain with the Company for a one-month handover period to ensure business continuity and will step down from the ValiRx Group after that period. Dr. Cathy Tralau-Stewart: Additionally, further to the announcement of 3 July 2024, the Company has appointed Dr. Cathy Tralau-Stewart as Executive Director with immediate effect. Cathy will also continue to hold the position of Chief Scientific Officer. Anuncio • Jun 19
Valirx plc Announces Resignation of Kevin Cox as Chairman and Director ValiRx plc announced that Kevin Cox has resigned as Chairman and Director of the Company with immediate effect. Anuncio • May 17
ValiRx plc, Annual General Meeting, Jun 20, 2024 ValiRx plc, Annual General Meeting, Jun 20, 2024. Location: the offices of dac beachcroft llp, the walbrook building, 25 walbrook, ec4n 8af, london United Kingdom Anuncio • Apr 23
Valirx plc Announces Directorate Changes ValiRx plc announced that, further to the announcements of 29 February and 19 March 2024, the Company has appointed Martin Gouldstone and Adrian de Courcey as Non-executive Directors with immediate effect, following completion of standard regulatory due diligence. In addition, Ray Horn has been appointed as a Board observer. Director Appointments: Adrian de Courcey: Adrian de Courcey is a business executive with experience in both corporate and entrepreneurial environments in the UK and internationally. He began his career with KPMG and held strategy roles with Shell and Johnson & Johnson, with experience within the SME sector and built a transportation business. Adrian graduated from the University of Warwick and obtained an MBA from the University of Cambridge in 2020. Current Directorships: Inishbofin Holdings Limited, Mike De Courcey Travel Limited, Tydfil Training Consortium Limited. 1Adrian de Courcey was appointed as a director of Mike De Courcey Travel Limited on 1 July 2006. On 3 August 2021 the company was placed in a creditors voluntary liquidation. The liquidation process is ongoing, Adrian de Courcey was appointed as a director of West Midlands Transport Information Services Limited on 5 October 2011. On 21 September 2018 the company appointed a voluntary liquidator to conduct a members voluntary liquidation. The Company was dissolved 30 November 2021 with no creditor shortfall. Previous Directorships held in the past five years: Leofric Biomass Limited, West Midlands Transport Information Services Limited. Martin Gouldstone is currently CEO of Oncimmune Holdings plc and has 30 years of corporate finance and business development experience in contract research organisations, healthcare and pharmaceutical sectors. Previously, Martin was a Global Senior Vice President of Business Development at Owkin Inc., where he managed the commercial teams in the USA and Europe and led new strategic research partnerships. More recently, Martin was Chief Business Officer at Sensyne Health; Global Senior Vice President and Head of Capital Solutions for Syneos Health; Chief Business Officer at BenevolentAI. Current Directorships: hVIVO PLC (previously Open Orphan PLC), Novara Therapeutics Limited, Oncimmune Holdings PLC, Sempiternum Ltd. Previous Directorships held in the past five years: Orthopaedic Research UK. Board Change • Apr 18
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 Chairman Kevin Cox was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. New Risk • Mar 11
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 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 (12% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (€5.83m market cap, or US$6.38m). Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Shareholders have been diluted in the past year (47% increase in shares outstanding). Anuncio • Feb 29
Valirx plc Intends to Appoint Martin Gouldstone as Non-Executive Director ValiRx Plc announced that, subject to normal regulatory due diligence, it intends to appoint Martin Gouldstone as a Non-Executive Director of the Company. Martin is currently CEO of Oncimmune Holdings plc and has 30 years of corporate finance and business development experience in contract research organisations, healthcare and pharmaceutical sectors. Previously, Martin was a Global Senior Vice President of Business Development at Owkin Inc., where he managed the commercial teams in the USA and Europe and led new strategic research partnerships. More recently, Martin was Chief Business Officer at Sensyne Health; Global Senior Vice President and Head of Capital Solutions for Syneos Health; Chief Business Officer at BenevolentAI. Martin was previously a Partner at Results Healthcare (now CG Results Healthcare), where he co-led the healthcare practice; Head of Lifesciences in the UK for BDO, M&A Lead for Europe at Quintiles (now IQVIA Inc), and held business development and licensing lead roles at Confirmant Ltd. and Sareum Holdings PLC. Martin has extensive experience buying and selling deals across Europe and the US, and in negotiating multi-year research partnerships. Currently, Martin is also a Non-Executive Director of hVIVO plc (formerly Open Orphan plc) and sits on the Board of Trustees of Orthopaedic Research UK. Martin holds a BSc in Genetics and has completed a range of postgraduate management courses. Anuncio • Jan 18
ValiRx plc Announces Resignation of Stella Panu as A Non-Executive Director, Effective from 15 April 2024 ValiRx plc announced the resignation of Stella Panu as a Non-Executive Director of the Company, effective from 15 April 2024. Following the fundraise in January 2024, Stella has decided to step down from the Board to concentrate on her other commitments. Stella has agreed to a 3-month handover period to allow sufficient time for the Board to identify an appropriate replacement and ensure a smooth transition of responsibilities. During Stella's tenure as a Non-Executive Director, she has made significant contributions to the development of the strategy and the changes required to ensure the Company achieves its longer-term growth goals. Stella's expertise and guidance have been invaluable, and the Company would like to express its gratitude for her dedicated service. With Stella's support, the Company will be working diligently to identify a suitable candidate to fill the vacancy created by her departure. Anuncio • Dec 21
ValiRx plc has completed a Follow-on Equity Offering in the amount of £0.192244 million. ValiRx plc has completed a Follow-on Equity Offering in the amount of £0.192244 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 3,204,068
Price\Range: £0.06 Anuncio • Dec 14
ValiRx plc, Annual General Meeting, Jan 04, 2024 ValiRx plc, Annual General Meeting, Jan 04, 2024, at 11:00 Coordinated Universal Time. Location: the offices of DAC Beachcroft LLP, 25 Walbrook London United Kingdom Agenda: To approve the issuance of the Placing Shares, the Retail Offer Shares, and the Subscription Shares. New Risk • Dec 12
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: €8.52m (US$9.17m) 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. This is currently the only risk that has been identified for the company. New Risk • Oct 05
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 15% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-UK£2.6m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (€8.18m market cap, or US$8.60m). Minor Risk Shareholders have been diluted in the past year (39% increase in shares outstanding). Anuncio • Jun 15
ValiRx plc (AIM:VAL) acquired scientific assets of Imagen Therapeutics Limited from Imagen Therapeutics Ltd for £0.17 million. ValiRx plc (AIM:VAL) acquired scientific assets of Imagen Therapeutics Limited from Imagen Therapeutics Ltd for £0.17 million on June 14, 2023. Transaction is financed from ValiRx plc's existing resources. Liam Murray, Jo Turner and Ludovico Lazzaretti of Cairn Financial Advisers LLP acted as financial advisor to ValiRx plc in the transaction.
ValiRx plc (AIM:VAL) completed the acquisition of scientific assets of Imagen Therapeutics Limited from Imagen Therapeutics Ltd on June 14, 2023. New Risk • Jun 09
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: €9.20m (US$9.90m) 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 Less than 1 year of cash runway based on free cash flow trend (-UK£1.7m free cash flow). Revenue is less than US$1m. Market cap is less than US$10m (€9.20m market cap, or US$9.90m). Minor Risks Share price has been volatile over the past 3 months (7.0% average weekly change). Shareholders have been diluted in the past year (39% increase in shares outstanding). Anuncio • Jun 05
ValiRx plc, Annual General Meeting, Jun 28, 2023 ValiRx plc, Annual General Meeting, Jun 28, 2023, at 10:00 Coordinated Universal Time. Location: At the offices of DAC Beachcroft LLP at The Walbrook Building, 25 Walbrook, London EC4N 8AF London United Kingdom Anuncio • May 26
ValiRx plc to Report Q4, 2022 Results on Jun 05, 2023 ValiRx plc announced that they will report Q4, 2022 results on Jun 05, 2023 Anuncio • Jan 31
ValiRx plc Appoints Cathy Tralau-Stewart as Chief Scientific Officer ValiRx plc confirmed the permanent appointment of Dr. Cathy Tralau-Stewart as Chief Scientific Officer. Dr. Cathy Tralau-Stewart was appointed as Interim CSO for ValiRx in 2022 under a consultancy arrangement. the company now announced that Cathy has agreed to become CSO on a permanent basis, focusing on developing a risk-balanced, collaborative preclinical pipeline. She will also actively support the Company strategically through membership of the Executive team and as a Board observer. Board Change • Nov 16
Less than half of directors are independent There are 4 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 4 new directors. 6 experienced directors. 1 highly experienced director. 2 independent directors (3 non-independent directors). CFO & Executive Director James Desler is the most experienced director on the board, commencing their role in 2006. Independent Non-Executive Chairman Kevin Cox was the last independent director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of experienced directors. Anuncio • Oct 11
ValiRx plc Appoints Stella Panu as Non-Executive Director ValiRx Plc announced the company has appointed Ms Stella Panu as Non-executive Director with immediate effect, following completion of standard regulatory due diligence. Stella was a founding Partner of Maven Capital Partner UK LLP ("Maven"), an investment management company, created after a management buyout of the private equity business of Aberdeen Asset Management plc ("AAM") in 2009, and led the business through to its sale in July 2021. Maven has a focus on venture growth and innovation and during her time at Maven, Stella led the AIM Investment team and was the lead investor in private equity across Maven. Stella was recently appointed a Non-executive Director of Vianet Group plc, an international provider of actionable data and business insight through devices connected to its Internet of Things platform ("IOT"). Having previously been at AAM and Seymour Pierce Ltd. and had seats on numerous company boards, Stella brings with her a wealth of private equity M&A and AIM experience. Stella has also previously worked for Pricewaterhouse Coopers, The World Bank, and Raifessen Investment Fund and holds a Bachelor's degree in Economics and an MA in Applied Economics and Statistics. Stella was previously a director of Dalglen (No. 1148) Limited. This company was one of Maven's VCT investments. The trading assets were sold to an acquiror in an asset sale and purchase transaction. Following the sale of the assets, the company was placed into voluntary liquidation and was dissolved on 7 June 2019. There were no outstanding amounts owed to creditors. Stella was previously director of Space Student Living Limited, a company in which Maven was invested. The Company was placed into liquidation on 12 December 2012 and subsequently dissolved on 9 December 2016. There were no amounts outstanding to creditors. Stella was previously a director of Wey Bridging Ltd. from 25 January 2010 to 26 November 2010. The company was placed into liquidation via a creditor's voluntary liquidation on 2 November 2011. There were no amounts outstanding to creditors. Stella was previously appointed a director ofCenturion Underwriting Agency Limited,a subsidiary of Torridon Capital Limited,on 9 February 2010. On 21 December 2010 the company was placed into liquidation and subsequently dissolved on 5 April 2011. There were no amounts outstanding to creditors. Additionally, Stellawas a director of the following companies that were dissolved via voluntary wind-up at the time of or in the 12 months following her directorship: Campsie Capital Limited; Cox Associates Limited; Elite Litigation Funding Limited; Perfect Consulting Limited; Sopco Management Limited; SPSAV investment Limited; SPSAV Management Company Limited Ms. Stella Panu does not own any ordinary shares or options over ordinary shares in the Company. Board Change • Sep 20
Less than half of directors are independent There are 4 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 4 new directors. 6 experienced directors. 1 highly experienced director. 2 independent directors (3 non-independent directors). CFO & Executive Director James Desler is the most experienced director on the board, commencing their role in 2006. Independent Non-Executive Chairman Kevin Cox was the last independent director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of experienced directors. Anuncio • Sep 08
ValiRx Plc Announces Appointment of Dr. Catherine Tralau Interim Chief Scientific Officer ValiRx Plc announced the appointment of Dr. Catherine ("Cathy") Tralau-Stewart as interim Chief Scientific Officer (a non-board position). Dr. Tralau-Stewart has experience working across leading pharmaceutical companies and academic groups, with a particular focus on the interaction between industry and academia. Her role within the Company will encompass the review of new, incoming science; enhancing the progress of existing projects; and influencing the overall strategic scientific direction of the Company. Anuncio • Jul 01
Kevin Alexander Ceased to Be Director of ValiRx ValiRx Plc announced that at its Annual General Meeting ("AGM") held earlier June 30, 2022, all resolutions were duly passed. As announced on 7 June 2022, Kevin Alexander has ceased to be a director of the Company following the conclusion of the AGM. Anuncio • Jun 08
ValiRx plc, Annual General Meeting, Jun 30, 2022 ValiRx plc, Annual General Meeting, Jun 30, 2022, at 10:00 Coordinated Universal Time. Location: DAC Beachcroft LLP at the The Walbrook Building 25 Walbrook, London EC4N 8AF London United Kingdom Recent Insider Transactions • Feb 19
Non-Executive Director recently bought €115k worth of stock On the 18th of February, Martin Lampshire bought around 440k shares on-market at roughly €0.26 per share. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought €139k more in shares than they have sold in the last 12 months. Anuncio • Feb 16
London, Uk - Valirx plc Announces That It Has Entered into A New Agreement with Physiomics Plc London, UK - ValiRx plc announced that it has entered into a new agreement with Physiomics plc, the oncology consultancy using mathematical models to support the development of cancer treatment regimens and personalised medicine solutions. The new agreement supersedes the agreement between Physiomics and the Group which was announced on 13 September 2011. Under the terms of the new agreement, ValiRx will benefit from Physiomics' experience in modelling the effects of prostate cancer treatment, as well the use of the latest version of its Virtual Tumour technology, which will be applied to derive valuable information from the additional data generated by the completed clinical trial of VAL201. Physiomics will also support ValiRx in modelling the use of the VAL201 peptide in endometriosis and Coronavirus. Anuncio • Dec 02
Valirx plc Receives the Full Dataset to Be Used for the Clinical Study Report from the Phase 1/2 Clinical Trial of Its Lead Asset, VAL201 ValiRx plc reports that it has received the full dataset to be used for the Clinical Study Report from the Phase 1/2 clinical trial of its lead asset, VAL201, for the treatment of locally advanced or metastatic prostate cancer and performed at University College Hospital (UCLH), London. This expands the positive headline results announced on 28 September 2020. The dataset provides a complete breakdown of the full data of safety and tolerability as well as evidence for encouraging disease impact as observed during the clinical trial. Recruitment Criteria: Twelve patients were recruited according to the criteria of having incurable, locally advanced or metastatic prostate cancer with rising PSA[1] (Prostate-Specific Antigen) on three consecutive samples and absent or very mild prostate cancer-related symptoms; The demographics and a detailed breakdown of the patients recruited is provided in the download.
Disease Impact: The headline results released in the Company announcement on 28 September 2020 highlighted the response rate of 54.5%, where response was confirmed by a lack of disease progression by PCWG2 (Prostate Cancer Working Group 2) criteria. The dataset now received provides the detailed breakdown of this by providing both the PSA modulation afforded by the treatment, and the tumour response; The PSA data, a recognised surrogate of disease progression, shows two patients seeing a decrease in PSA during their treatment period, one of which maintained the decrease throughout the trial. An analysis of the doubling time of patients shows a statistically significant (p<0.05, two-tailed Wilcoxon Signed-Rank test for paired samples) increase in PSA doubling time comparing pre-treatment doubling time to post-treatment doubling time. The PSA doubling time would be expected to be unchanged if the treatment was having no impact, so an increase in doubling time demonstrates a slowing rate of growth of PSA levels; The tumour response data demonstrates that patients did not have an increase in metastatic lesions during the treatment period, and that metastatic lesions already present did not grow at all in two out of three patients, suggesting a positive influence of VAL201 on the disease. Anuncio • Sep 30
ValiRx plc Reports Headline Results from the Recently Completed Phase 1/2 Clinical Trial of its Lead Asset VAL201 ValiRx plc reported that it has received headline results from the recently completed Phase 1/2 clinical trial of its lead asset VAL201, for the treatment of advanced prostate cancer, held at University College Hospital (UCLH), London. The headline results, detailed below, provide a summary of the top-level data of safety and tolerability as well as evidence for disease impact as observed during the clinical trial. Full data and details of from the clinical trial are expected to be received by the Company by end the fourth quarter of 2020. Evidence for positive disease impact has been measured using PCWG2 (Prostate Cancer Working Group 2) guidelines. These industry standard guidelines take into account both the primary tumour and metastatic tumours alongside prostate specific antigen (PSA) levels to assess whether the disease has progressed, or whether the patient has responded and halted disease progression. These guidelines provide a more comprehensive measure of disease impact than just primary tumour imaging. Of the 12 patients dosed with VAL201, 11 patients had sufficient PCWG2-relevant data collected across multiple cycles. 6 of these 11 have been categorised as responding throughout treatment. That is, when the treatment with VAL201 was halted for a defined reason, whether or not the 6 standard cycles had been completed, these patients showed no disease progression by PCWG2 criteria with stable disease. As the first clinical trial of VAL201, safety and tolerability data are of paramount importance. The headline safety and tolerability results demonstrated only one dose-limiting toxicity event occurred. This was at a maximum dose of 8 mg/kg, with the patient having raised blood pressure (severe hypertension). Following treatment for the raised blood pressure, the patient completed the remainder of the trial. A Maximum Tolerated Dose has not been determined for VAL201, and all doses remain available for further testing. No deaths were reported in patients during the clinical trial. Further minor events listed as likely to be related to the administration of VAL201 are: Injection site disorders in 11 out of 12 patients; fatigue (5/12); dyspepsia (1/12); muscle spasm (1/12); hypertension (2/12); bradycardia (1/12). During the fourth quarter of 2020, the Company expects to receive the full Clinical Study Report and will use the complete data to publish the results on the National Institute of Health's (NIH) public database ClinicalTrials.gov, as well as to produce research papers for peer-reviewed publications. The company intends to share these results with potential industry partners to evaluate all options for further clinical development of VAL201. Is New 90 Day High Low • Sep 23
New 90-day high: €0.38 The company is up 388% from its price of €0.078 on 25 June 2020. The German market is up 3.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 2.0% over the same period.