Aankondiging • Jun 29
Redx Pharma Plc Reports Encouraging Zamaporvint (RXC004) Phase 2 Combination Data in MSS mCRC at ESMO GI Congress Redx Pharma Plc announced data from all Phase 2 clinical trial modules of zamaporvint (RXC004), a potent, selective, orally-active Porcupine inhibitor in development for Wnt-ligand dependent, hard-to-treat GI cancers at the European Society for Medical Oncology Gastrointestinal Cancers (ESMO GI) Congress. These data were from small, signal searching patient cohorts in the PORCUPINE study, investigating genetically-selected patients (RNF43_mutant/RSPO-fusion subgroup) with microsatellite stable metastatic colorectal cancer (MSS mCRC) as monotherapy and in combination with anti-PD-1 (NCT04907539); and the PORCUPINE2 study investigating all-comers biliary tract cancer (BTC) as monotherapy and anti-PD-1 combination, as well as genetically-selected pancreatic cancer as monotherapy (NCT04907851). Zamaporvint has been shown to have a tolerable safety profile and is the first Porcupine inhibitor to demonstrate efficacy across this hard-to-treat RNF43/RSPO patient subgroup. Partial responses observed in approximately 30% (2/7) of genetically-selected patients when combined with nivolumab in the PORCUPINE MSS mCRC module is encouraging in a late-line patient population who have previously undertaken a median of two prior lines of therapy, and where anti-PD-1 alone is not effective. This suggests activity levels potentially better than late-line standard of care in this setting. Furthermore, a disease control rate =16 weeks of 57% (4/7), higher than zamaporvint monotherapy at 15% (2/13), indicates the potential for zamaporvint in combination with immune checkpoint inhibition to drive durable efficacy outcomes. Consistent with this, robust metabolic (FDG-PET) and molecular (ctDNA) responses were observed in all patients that achieved disease control (partial response or stable disease) following zamaporvint treatment with or without nivolumab. The results from the PORCUPINE2 study also showed some durable clinical benefit in the BTC module in an all-comers (unselected) patient group, albeit at a lower level than that observed in genetically-selected MSS mCRC. In the RNF43 mutated pancreatic ductal adenocarcinoma (PDAC) cohort, although one partial response was observed in the monotherapy module, participant numbers in the present study are too low to support any conclusion on efficacy. However, further investigator sponsored studies in this indication are being planned. In both the PORCUPINE and PORCUPINE2 studies all patients received prophylactic denosumab that successfully prevented any treatment related bone effects, a known effect of Wnt inhibition. Overall, the data from these signal searching studies show enhanced activity of zamaporvint within the RNF43/RSPO MSS subgroup of GI cancers. Furthermore, they support clinical development in this subgroup in combination with anti-PD-1 where see an exciting opportunity for Wnt pathway inhibition by zamaporvint to reverse innate anti-PD-1 resistance. Other rational zamaporvint combination opportunities to enhance patient benefit, such as with early line chemotherapies or with EGFR/MAPK pathway inhibitors, also exist in wider GI cancer patient populations. Redx is seeking a partner to support ongoing clinical development. Aankondiging • Jun 21
Redx to Present Zamaporvint Phase2 Data At Esmo Gi Redx Pharma announced that Phase 2 data from zamaporvint (RXC004), a Porcupine inhibitor targeting Wnt-ligand dependent GI cancers, will be presented at the European Society for Medical Oncology Gastrointestinal Cancers Congress (ESMO GI), 26-29th June, Munich, Germany. Zamaporvint is a potent, selective, orally-active Porcupine inhibitor in development for hard-to-treat GI cancers. The principal efficacy hypothesis for zamaporvint is for use in combination, which has been investigated in Phase 2 signal searching patient cohorts with anti-PD-1 therapy. Monotherapy for single agent activity has also been investigated. The PORCUPINE study was in genetically-selected patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) as monotherapy and immuno-oncology combination (clinicaltrials.govNCT04907539). The PORUPINE2 study was in all-comers biliary tract cancer as monotherapy and immuno-oncology combination, and in genetically selected pancreatic cancer as monotherapy. The data will be presented in two posters, one on the PORCUPINE study and one on the PORCUPINE2 study. Notably, these data demonstrate that zamaporvint, in combination with an anti-PD-1 agent in genetically-selected patient populations has the potential to improve upon efficacy outcomes achieved with standard of care alone. Aankondiging • Jun 18
Redx to Present Preclinical Data on RXC008 in an Oral Presentation at ECM Congress Redx Pharma announced that preclinical data from the Company's oral GI-targeted pan-ROCK inhibitor, RXC008, will be presented in an oral presentation at the Extracellular Matrix Pharmacology Congress ('ECM'), being held in Copenhagen, Denmark, 17-19th June 2024. RXC008 is a potential first-in-class treatment for fibrostenotic Crohn's disease and is specifically designed to target fibrosis in the gastrointestinal tract and to degrade quickly, if absorbed into the bloodstream, through enzyme-mediated metabolism. Preclinical data from RXC008 has shown strong anti-fibrotic therapeutic effects in multiple animal models of inflammatory bowel disease. A Phase 1 Healthy Volunteers study of RXC008 (RXC008-0001) commenced in early 2024, with data expected by the year end. Dr. Kirsty Houslay, Principal Scientist at Redx, will make an oral presentation discussing preclinical data from studies of RXC008 in various animal models of fibrosis and Crohn's disease. Crohn's disease affects 1.7m1 people globally and >70,000 new cases are diagnosed each year. More than 50% of patients2 with Crohn's disease can develop significant fibrosis and stricture formation within ten years after diagnosis; this fibrosis associated with Crohn's disease is known as fibrostenotic Crohn's disease. The current management of fibrotic strictures of the gastrointestinal tract is primarily surgical as no drugs are specifically approved for fibrosis, which can progress despite intervention with anti-inflammatory therapies. Aankondiging • Apr 30
Redx Pharma Provides Update on AIM Delisting Redx Pharma Plc provided a further update with respect to the cancellation of the admission of its ordinary shares of 1 pence each to trading on AIM, as originally announced on 2 April 2024. As previously announced, the last day of trading in the Ordinary Shares on AIM will be 30 April 2024 and the AIM Delisting will become effective at 7:00 a.m. on 1 May 2024. Details of the matched bargain facility to be provided by J P Jenkins to assist shareholders wishing to trade in Ordinary Shares following the AIM Delisting will be available on the Company's website www.redxpharma.com. The matched bargain facility will be effective from 7:30 a.m. on 1 May 2024. Aankondiging • Feb 28
Redx Announces That First Participant Dosed in Phase 1 Trial of RXC008 Redx announced that the first participant has been dosed in a Phase 1 clinical trial for RXC008. RXC008 is a wholly-owned gastro-intestinal (GI) targeted Rho Associated Coiled-Coil Containing Protein Kinase (ROCK) inhibitor, being developed as a potential first-in-class treatment for patients with fibrostenotic Crohn's disease. The primary objective of this first-in-human study is to evaluate the safety and pharmacokinetic (PK) profile of the drug and it is expected that results from the healthy volunteer cohorts will be available by the end of 2024. Fibrostenotic Crohn's disease is a chronic condition that causes inflammation and fibrotic stricture formation in the GI-tract. Over 50% of patients diagnosed with Crohn's disease will develop fibrostenosis within 10 years of diagnosis. There are currently no drugs specifically approved for the underlying fibrosis, which can progress despite intervention with anti-inflammatory therapies. The only current treatment options are invasive surgical procedures to remove the affected part of the GI-tract with the majority of patients requiring many successive surgical interventions. The Phase 1 clinical study consists of two parts. The first in healthy volunteers includes both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, the latter being dosed for 14 days. The primary endpoint for the healthy volunteer cohorts will be safety, with secondary endpoints being related to RXC008's PK profile. The second part of the study will investigate patients with fibrostenotic Crohn's disease who will be dosed for a one-month duration with a placebo control, to show safety along with PK profile, target engagement and changes in circulating biomarkers. Data from the healthy volunteer cohorts are expected to be available by the end of 2024. RXC008 is a potent, oral, small molecule non-systemic ROCK 1/2 inhibitor that avoids the significant cardiovascular side effects of pan-ROCK inhibitors, including tachycardia and hypotension, by being restricted to the GI-tract via high efflux and low permeability. This results in virtually no systemic breakthrough, with the molecule being rapidly metabolised by paraoxonase enzymes in the plasma should any breakthrough occur under particular circumstances. RXC008 has a strong preclinical package across multiple therapeutic models, data from which was presented at the 2022 Inflammatory Bowel Disease (IBD) Nordic Conference, including results from a therapeutic 12-week DSS model with a closely related GI-targeted ROCK inhibitor, REDX08087. In this model Redx was able to show complete reversal of preformed GI-fibrosis as measured by trichome collagen staining, fully reversing fibrosis back to baseline levels. This level of anti-fibrotic effect is the strongest seen in any of Redx's fibrosis models and modes of action to date. RXC008 is being developed to be used in conjunction with anti-inflammatories and other symptomatic treatments for Crohn's to address the underlying fibrosis of the disease. Reported Earnings • Feb 19
Full year 2023 earnings released: UK£0.099 loss per share (vs UK£0.061 loss in FY 2022) Full year 2023 results: UK£0.099 loss per share (further deteriorated from UK£0.061 loss in FY 2022). Revenue: UK£4.20m (down 78% from FY 2022). Net loss: UK£33.2m (loss widened 84% from FY 2022). Products in clinical trials Phase II: 2 Revenue is expected to decline by 47% p.a. on average during the next 2 years, while revenues in the Pharmaceuticals industry in Germany are expected to grow by 3.1%. Over the last 3 years on average, earnings per share has fallen by 9% per year but the company’s share price has fallen by 31% per year, which means it is performing significantly worse than earnings. Aankondiging • Feb 17
Redx Pharma Plc, Annual General Meeting, Mar 14, 2024 Redx Pharma Plc, Annual General Meeting, Mar 14, 2024, at 11:00 Coordinated Universal Time. Location: Cooley (UK) LLP,22 Bishopsgate London United Kingdom Agenda: To receive the Company's annual accounts for the financial year ended 30 September 2023 together with the directors' report, the directors' remuneration report and the auditors' report on those accounts; to re-appoint Ernst & Young LLP as auditors of the Company and to authorise the directors to determine their remuneration; to elect Dr Joseph Anderson as a director of the Company, who was appointed as a director on 6 September 2023 by the board of directors of the Company, in accordance with article 24.3 of the Company's articles of association; and to consider other matters. New Risk • Feb 08
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 9.4% a week. This is considered a minor risk. Share price volatility indicates 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. It also 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. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 16% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (UK£45m net loss in 2 years). Share price has been volatile over the past 3 months (9.4% average weekly change). Shareholders have been diluted in the past year (16% increase in shares outstanding). New Risk • Jan 30
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: €91.3m (US$98.9m) This is considered a minor 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 Risk Earnings are forecast to decline by an average of 6.2% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (UK£41m net loss in 2 years). Shareholders have been diluted in the past year (16% increase in shares outstanding). Market cap is less than US$100m (€91.3m market cap, or US$98.9m). Reported Earnings • Dec 16
Full year 2023 earnings released: UK£0.099 loss per share (vs UK£0.061 loss in FY 2022) Full year 2023 results: UK£0.099 loss per share (further deteriorated from UK£0.061 loss in FY 2022). Revenue: UK£4.20m (down 78% from FY 2022). Net loss: UK£33.2m (loss widened 84% from FY 2022). Aankondiging • Dec 12
Redx Pharma Plc to Report Fiscal Year 2023 Results on Dec 15, 2023 Redx Pharma Plc announced that they will report fiscal year 2023 results on Dec 15, 2023 New Risk • Dec 03
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended March 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: Minor Risks Latest financial reports are more than 6 months old (reported March 2023 fiscal period end). Currently unprofitable and not forecast to become profitable next year (UK£31m net loss next year). Shareholders have been diluted in the past year (17% increase in shares outstanding). Aankondiging • Oct 30
Redx Pharma plc to Present Preclinical Data on RXC009, A Selective Discoidin Domain Receptor 1 Inhibitor Redx Pharma Plc announced that it will present preclinical data from its recently-nominated development candidate, RXC009 at the American Society of Nephrology (ASN) Annual Meeting (2-5 November 2023, Philadelphia, PA). Redx nominated RXC009 as a development candidate in October 2023. RXC009 is a small molecule, orally available, highly potent and selective DDR1 inhibitor and a potential first-in-class treatment for chronic kidney disease (CKD). CKD affects 8% to 16% of the population worldwide and is most commonly attributed to diabetes and hypertension. Renal fibrosis, characterized by tubulointerstitial fibrosis and glomerulosclerosis, is one of the final manifestations of CKD as it progresses and is associated with high morbidity. DDRs have recently gained traction as druggable targets with the potential to treat multiple fibrotic conditions, including kidney fibrosis associated with CKD such as in Alport Syndrome, butto date, no selective inhibitors of DDR1 have entered the clinic. Aankondiging • Oct 18
Redx Pharma Plc has completed a Follow-on Equity Offering in the amount of £14.059359 million. Redx Pharma Plc has completed a Follow-on Equity Offering in the amount of £14.059359 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 54,074,458
Price\Range: £0.26
Transaction Features: Subsequent Direct Listing Aankondiging • Sep 07
Redx Pharma plc Appoints Joseph Anderson as Non-Executive Director Redx Pharma Plc announced the appointment of Dr. Joseph Anderson as a Non-Executive Director on the Board of Directors of the Company (the ‘Board’), effective immediately. Dr. Anderson will join the Board as a representative of Sofinnova Crossover I SLP (‘Sofinnova’), one of the Company's major shareholders. As previously announced on 3 July 2023, Dr. Anderson's appointment was subject to due diligence and other appointment processes which have now completed. Dr. Joseph Anderson, aged 64, holds or has previously held the following directorships: Current directorships: F2g Ltd. and Autolus Therapeutics Plc; Former directorships: Arix Bioscience Plc. Aankondiging • Aug 22
Redx Pharma Plc Announces Executive Changes Redx Pharma Plc announced that Sarah Gordon-Wild, independent non-executive director on the Board of Directors has resigned, for personal reasons, as a director of the company effective at the end of the company's current financial year on 30 September 2023. Ms. Gordon-Wild was appointed to the Board on 1 June 2020. At this time, the Company does not intend to appoint a replacement independent non-executive director to the Board following Ms. Gordon-Wild's resignation becoming effective. Ms. Gordon-Wild is currently Chair of the Remuneration Committee and a member of the Audit Committee of the Board. Following her resignation becoming effective, it is intended that Dr. Bernhard Kirschbaum will be appointed Chair of the Remuneration Committee. The Board does not currently intend to appoint a replacement director for Ms. Gordon-Wild to either Committee. Aankondiging • Aug 21
Redx Pharma plc Zelasudil Receives FDA Orphan Drug Designation Redx announces that zelasudil (RXC007), an oral, selective Rho Associated Coiled-Coil Containing Protein Kinase 2 (ROCK2) inhibitor, has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for the potential treatment of Idiopathic Pulmonary Fibrosis (IPF). Zelasudil is currently in a Phase 2a clinical study for IPF, with topline data expected in first quarter of 2024. The FDA can grant Orphan Drug Designation to support the development and evaluation of new treatments to prevent, diagnose or treat a rare disease or condition that affects fewer than 200,000 in the US. The designation provides Redx with various development and commercial incentives, including market exclusivity, in order to address this unmet need for patients suffering from IPF. New Risk • Aug 04
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: €89.4m (US$97.9m) This is considered a minor 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£30m free cash flow). Earnings are forecast to decline by an average of 5.2% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable next year (UK£41m net loss next year). Market cap is less than US$100m (€89.4m market cap, or US$97.9m). Aankondiging • Jul 04
Redx Pharma Plc Announces Directorate Changes Redx Pharma Plc announces that Dr. Thomas Burt, Non-Executive Director, has informed the Board of Directors of the Company ("the Board") of his intention to resign as a Director of the Company with effect from 1 September 2023. Dr. Burt is currently the representative of Sofinnova Crossover 1 SLP ("Sofinnova"), one of the Company's major shareholders. Sofinnova has nominated Dr. Joe Anderson to be their new representative. It is therefore anticipated that Dr. Anderson will, subject to due diligence and other appointment processes, join the Board following Dr. Burt's resignation becoming effective. Reported Earnings • May 18
First half 2023 earnings released: UK£0.062 loss per share (vs UK£0.035 loss in 1H 2022) First half 2023 results: UK£0.062 loss per share (further deteriorated from UK£0.035 loss in 1H 2022). Revenue: UK£2.31m (down 72% from 1H 2022). Net loss: UK£20.8m (loss widened 113% from 1H 2022). Revenue is forecast to grow 103% p.a. on average during the next 2 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany. Aankondiging • May 13
Redx Pharma Plc's Discovery of Pirtobrutinib Recognised with Unveiling of Commemorative Plaque At Alderley Park Redx Pharma plc announced that a commemorative plaque has been unveiled by Bruntwood SciTech at their Alderley Park campus, where Redx is headquartered, in recognition of the team's discovery of pirtobrutinib, the active pharmaceutical ingredient (API) in Eli Lilly's Jaypirca. On 27 January 2023, Lilly announced the approval of pirtobrut inib by the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. More recently, in April 2023, the drug also received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP). Pirtobrutinib, is a highly selective kinase inhibitor and is the first and only FDA approved non-covalent (reversible) BTK inhibitor available. PirtobrutinIB, formerly known as RXC005, was discovered by Dr. Nicolas Guisot, Vice President, Drug Discovery and the team at Redx. The team at Redx should be incredibly proud to have originated a molecule that has made it to market given that fewer than 5% of preclinical projects currently achieve this milestone. It also serves to highlight that an FDA approval is the culmination of years of work, requiring significant investment, which often forces the UK biotech community to secure partnerships and investment from outside the UK so their research can become reality. With its world-class innovation capabilities, of which pirtobrutinIB offers a shining example, the UK can be a real force in the global biotech market and greater financial and political support from within will help ensure more of the ultimate returns are captured by the UK economy. Redx has a strong track record of discovering new drug candidates through its core strengths in medicinal chemistry and translational science, enabling the Company to discover and develop potential best-in-class, or first-in-class therapeutics. Pirtobrut inib is one of five molecules originat. Aankondiging • May 11
Redx Pharma Plc Presents Preclinical Efficacy Data for RXC007 Showing Significant Results in Cancer-Associated Fibrosis Models Redx Pharma Plc announced additional preclinical data for its lead fibrosis asset, RXC007, and the Discodin Domain Receptor (DDR)1/2 discovery programme, as presented at the Resistant Tumour Microenvironment, Keystone Symposia, in Vancouver, BC. The data presented were from preclinical models of pancreatic ductal adenocarcinoma (PDAC) and triple negative breast cancer (TNBC), in combination with chemotherapy and immunotherapy, as current standard of care. RXC007, in combination with gemcitabine/Abraxane® in metastatic and high- extra cellular matrix (ECM) patient-derived PDAC models, was shown to increase survival compared to single agent standard of care alone. The combination of RXC007 with standard of care provided a significant increase in median survival days from date of treatment in a dose dependent manner. These new data on RXC007 complement those also presented at the meeting by collaboration partner the Garvan Institute of Medical Research on REDX10616, a close analogue of RXC007, which were also presented at the Extracellular Matrix Pharmacology congress last year. These data show REDX10616, in combination with FOLFIRINOX, re-sensitised a FOFIRINOX-resistant patient derived xenograft (PDX) model to treatment and led to a striking increase in survival in combination with the standard of care triplet chemotherapy. Taken together, these data provide a strong rationale for the potential of ROCK2 inhibition in combination with standard of care as a potential treatment for cancer-associated fibrosis. Redx plans to further investigate this treatment setting with the Company's next-generation ROCK2 inhibitor, RXC007, in the clinic. Additionally, at the Keystone Symposia, further data were also presented from Redx's DDR1/2 programme in combination with anti-PD-1 in TNBC models. Using a tool DDR1/2 inhibitor, in combination with anti-PD-1, in the TNBC E0771 model resulted in a statistically significant increase in survival when compared to the control group, an effect not observed with either single agent alone. Aankondiging • May 10
Redx Pharma Plc to Report First Half, 2023 Results on May 17, 2023 Redx Pharma Plc announced that they will report first half, 2023 results on May 17, 2023 Reported Earnings • Feb 18
Full year 2022 earnings released: UK£0.061 loss per share (vs UK£0.084 loss in FY 2021) Full year 2022 results: UK£0.061 loss per share (improved from UK£0.084 loss in FY 2021). Revenue: UK£18.7m (up 86% from FY 2021). Net loss: UK£18.0m (loss narrowed 17% from FY 2021). Products in clinical trials Phase II: 2 Revenue is expected to decline by 2.6% p.a. on average during the next 2 years, while revenues in the Pharmaceuticals industry in Germany are expected to grow by 3.5%. Aankondiging • Feb 16
Redx Pharma Plc, Annual General Meeting, Mar 14, 2023 Redx Pharma Plc, Annual General Meeting, Mar 14, 2023, at 11:00 Coordinated Universal Time. Location: The offices of Cooley (UK) LLP 22 Bishopsgate London United Kingdom Aankondiging • Feb 10
Redx Pharma Plc Provides Progress Updates on RXC007 Clinical Programme Redx Pharma Plc announced a progress update on lead fibrosis candidate RXC007. RXC007 is an oral, selective Rho Associated Coiled-Coil Containing Protein Kinase 2 (ROCK2) inhibitor which is currently being assessed in a Phase 2a study in idiopathic pulmonary fibrosis (IPF). The Phase 2a IPF study is a multi-cohort, randomised, double-blind, placebo-controlled dose ranging study to assess safety and tolerability over a 12-week dosing period, as well as early signals of efficacy. In parallel, the study incorporates a translational science sub-study to evaluate target engagement and fibrosis modification over a 28-day dosing period. Following the announcement on 11 October 2022 of first patient enrolment in the trial, regulatory and ethics approvals for both the 28-day and the 12-week cohorts have been received in five countries across Europe, and recruitment is progressing at a number of study sites. Additionally, there is an open IND in the US and study sites are currently being initiated, allowing enrolment into the 28-day translational science sub-study. US enrolment into the 12-week cohorts of the study has not commenced and is currently under an FDA partial clinical hold pending the data readout from an ongoing non-clinical programme. The requested data, at clinically relevant doses, is expected later this year and Redx believe will support the longer dosing duration. Ongoing US site set up and enrolment into the 28-day cohort is unaffected. Overall, based on the current patient recruitment rate, topline data from this Phase 2a study are expected to be available in First Quarter 2024. ROCK2 inhibition is now a commercially validated target with potential in multiple disease areas, following the recent FDA approval and launch of the first drug with this mechanism of action for the treatment of chronic graft versus host disease (cGvHD). In addition to the ongoing clinical development plan in IPF, Redx has also generated consistently supportive preclinicaldata thathighlights the broad potential of next-generation ROCK2 inhibitors across a number of fibrotic indications where there remains a significant unmet need. Redx recently presented proof-of-concept data at the International Colloquium on Lung and Airway Fibrosis (ICLAF)1 that detailed development work in immune mediated models of cGvHD, wherethe underlying disease mechanisms that drive pathology in the model show similarities to those observed in the lung pathology of auto-immune driven fibrotic diseases such as systemic sclerosis and interstitial lung disease (ILD).Furthermore, encouraging data from an ongoing collaboration with the Garvan Institute of Medical Research, presented at the Antifibrotic Drug Development Summit (AFDD)2, has shown the potential of Redx's ROCK2 inhibitors in cancer-associated fibrosis, such as that seen in pancreatic cancer. Redx plans to provide updates on further development as appropriate. Reported Earnings • Dec 21
Full year 2022 earnings released: UK£0.061 loss per share (vs UK£0.084 loss in FY 2021) Full year 2022 results: UK£0.061 loss per share (improved from UK£0.084 loss in FY 2021). Revenue: UK£18.7m (up 86% from FY 2021). Net loss: UK£18.0m (loss narrowed 17% from FY 2021). Revenue is forecast to grow 32% p.a. on average during the next 2 years, compared to a 4.0% growth forecast for the Pharmaceuticals industry in Germany. Aankondiging • Dec 13
Redx Pharma Plc to Report Q4, 2022 Results on Dec 20, 2022 Redx Pharma Plc announced that they will report Q4, 2022 results on Dec 20, 2022 Board Change • Nov 17
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Non-Executive Director Rob Donald Scott was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Nov 07
Redx Pharma plc to Present on Potential of RXC007 in Fibrotic Diseases at Antifibrotic Drug Discovery Meeting Redx announced that Dr. Nicolas Guisot, VP, Drug Discovery at Redx Pharma, will speak at the Antifibrotic Drug Discovery (AFDD) Meeting (9-11 November 2022, Boston, MA) and present a poster on the Company's lead fibrosis asset, RXC007. In the presentation, which will take place on Friday 11 November at 09:30 am (EST), Dr Guisot will discuss RXC007, focusing on selectiveRho-Associated Coiled-Coil Containing Protein Kinase 2 (ROCK2) inhibition in lung fibrosis, other fibrotic diseases and in cancer- associated fibrosis. In addition to Dr Guisot's presentation, Redx will present a poster at the AFDD Meeting on Thursday 10 November at 3:00 pm (EST), which details the potential of RXC007 in the treatment of fibrosis, including foridiopathic pulmonary fibrosis (IPF) and chronic fibrosing interstitial lung disease (CF-ILD), where there is robust preclinical efficacy data across disease models supporting clinical development in these areas. RXC007 is a highly potent, selective and orally-active ROCK2 inhibitor targeting multiple diseases associated with fibrosis, being developed for interstitial lung disease, including IPF. A Phase 2a study assessing RXC007as a potential treatment for patients withIPF began in October 2022, with headline data anticipated to be available in H2 2023. Aankondiging • Oct 11
Redx Pharma plc Announces First Patient Dosed in Phase 2a Trial for RXC007 Redx announces the first patient has been dosed in the Phase 2a study assessing RXC007, a wholly-owned Rho Associated Coiled-Coil Containing Protein Kinase 2 (ROCK2) selective inhibitor, as a potential treatment for patients with idiopathic pulmonary fibrosis (IPF). The Phase 2a study is a 12-week multi-cohort, randomised, double-blind, placebo-controlled dose ranging study to assess early signals of efficacy as well as the safety and tolerability of RXC007 in IPF patients. Both treatment-naïve patients and patients already on approved IPF therapy will be included in the study. Key endpoints for the study will be safety and pharmacokinetic profile; changes from baseline in lung function of forced vital capacity (FVC) and carbon monoxide diffusion coefficient (DLCO); and changes from baseline in Quantative Lung Fibrosis Score (QLFS), airway volume and resistance on high resolution computerised tomography (HRCT) scan. In the study three dose escalation cohorts of 16 patients will be assigned a dosing period of three months, with patients potentially continuing for longer if they are seen to be tolerating their assigned treatment and there are no signs of disease progression. A translational science sub-study will commence in parallel to evaluate target engagement and disease interaction. Endpoints for this sub-study will include changes from baseline in blood biomarkers, proteins and genes from broncho-alveolar lavage (BAL) fluid, BAL-fluid cells and bronchial epithelial cells. Aankondiging • Jun 28
Redx Pharma Announces Two Presentations Were Delivered at the Inaugural Extracellular Matrix Pharmacology Congress in Copenhagen, 23-25 June Redx Pharma Plc announced that two presentations were delivered at the inaugural Extracellular Matrix Pharmacology Congress ("ECM 2022") in Copenhagen, 23-25 June. The presentations highlighted novel preclinical research performed by the Company and academic collaborators including encouraging data supporting Redx's Porcupine and ROCK inhibitors as potential novel treatments for cancer-associated fibrosis. Collaboration partner, Professor Marina Pajic of the prestigious Garvan Institute of Medical Research (the "Garvan") in New South Wales, Australia presented the RXC004 (PORCUPINE) and ROCK2 selective inhibitor data showing that targeting fibrosis associated with pancreatic cancer led to increased survival in mouse models. The collaboration between Redx and the Garvan was announced on 5 April 2022. In a second presentation,Head of Inflammation and Fibrosis at Redx, Dr Peter Bunyard, presented data supporting RXC008, a GI-targeted ROCK inhibitor, as a potential first-in-class treatment for fibrostenotic Crohn's disease. The presented results were from a research collaboration between Redx and scientists at Belgium's Ghent University and assessed the preclinical efficacy of RXC008 based on the use of magnetic resonance imaging (MRI) texture analysis to determine fibrotic changes in the colon. The data showed that RXC008 could significantly reduce fibrosis in the mouse dextran sulfate sodium(DSS) model measured by both histology and, for the first time, non-invasive MRI. This study therefore highlights that RXC008 has the potential to be the first pharmaceutical treatment for fibrostenotic Crohn's disease, reducing or replacing the need for repeated and debilitating surgical interventions, currently the only treatment option for patients, and that MRI could be used to monitor the effectiveness of new treatments in the clinic without the need for invasive biopsy. Reported Earnings • Jun 24
First half 2022 earnings released First half 2022 results: Revenue: (down 100% from 1H 2021). Net income: (up UK£12.7m from 1H 2021). Profit margin: (up from net loss in 1H 2021). The move to profitability was driven by lower expenses. Over the next year, revenue is expected to shrink by 52% compared to a 7.7% growth forecast for the industry in Germany. Aankondiging • Jun 16
Redx Pharma Plc to Report Q2, 2022 Results on Jun 23, 2022 Redx Pharma Plc announced that they will report Q2, 2022 results on Jun 23, 2022 Aankondiging • May 20
Redx Pharma Plc has completed a Follow-on Equity Offering in the amount of £34.261864 million. Redx Pharma Plc has completed a Follow-on Equity Offering in the amount of £34.261864 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 58,070,956
Price\Range: £0.59
Transaction Features: Regulation S; Rule 144A; Subsequent Direct Listing Board Change • Apr 27
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Non-Executive Director Rob Donald Scott was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Apr 10
Redx Pharma Plc Presents Encouraging RXC004 Preclinical Data Redx Pharma Plc announced that its poster at the American Association for Cancer Research (AACR) Annual Meeting will be available for viewing from 8 April 2022. A formal presentation of the poster by the authors will be made at the conference on 12 April. RXC004, a highly potent and selective, orally active once-daily Porcupine inhibitor, is being developed as a targeted therapy for Wnt-ligand driven cancer. It is currently being evaluated as monotherapy in Phase 2 proof-of-concept clinical trials in genetically selected patients with pancreatic cancer and metastatic colorectal cancer and in unselected patients with biliary cancer. Additionally, RXC004 is in a Phase 1 combination study with nivolumab, an anti-PD-1 antibody from which a dose for the combination arm of the Phase will be selected this year. Data readouts from the Phase 2 studies are expected in 2023. The poster presented at the AACR meeting and entitled 'Pre-clinical efficacy of the Wnt pathway inhibitor RXC004 in combination with anti-cancer therapies' describes preclinical data which demonstrate that RXC004 in combination with clinically relevant standard of care chemotherapy regimens could lead to potential benefit, including survival, over chemotherapy alone. The poster hypothesised that the RXC004-induced downregulation of DNA repair pathway genes observed in vitro could contribute to the beneficial effect seen in combination with a PARP inhibitor in vitro as well as the combination effect observed in vivo with the standard of care chemotherapy agents. Aankondiging • Mar 30
Redx Pharma plc Announces Nomination of Clinical Development Candidate Redx Pharma Plc announced the nomination of RXC008, a potential first in class treatment for fibrostenotic Crohn's disease, as its next clinical development candidate. RXC008 is a Gastrointestinal (GI) targeted Rho Associated Coiled-Coil Containing Protein Kinase (ROCK) inhibitor designed to act exclusively in the GI tract at the site of fibrosis in Crohn's disease patients. Up to 50% of patients with Crohn's disease can develop significant fibrosis and stricture formation within ten years after diagnosis; this fibrosis associated with Crohn's disease is known as fibrostenotic Crohn's Disease. The current management of fibrotic strictures of the GI tract is primarily surgical as no drugs are specifically approved for fibrosis, which can progress despite intervention with anti-inflammatory therapies. RXC008 is designed to work specifically at the site of fibrosis in the GI tract and to degrade quickly, if absorbed into the bloodstream, through enzyme-mediated metabolism. Preclinical data from Redx's GI-targeted ROCK inhibitor research project shows strong anti-fibrotic therapeutic effects in multiple animal models of inflammatory bowel disease. RXC008 could address the high unmet need in the treatment of fibrostenotic Crohn's disease by potentially slowing or reversing disease progression and avoiding the need for surgical intervention, thereby improving patients' quality of life. The Company plans to initiate a Phase 1 study with RXC008 at the end of 2023. This programme will be the third development candidate that Redx has progressed in the area of fibrosis. RXC007, an orally available, selective ROCK2 inhibitor for development in idiopathic pulmonary fibrosis (IPF), commenced first in human studies in June 2021 and RXC006, an orally available porcupine inhibitor is being progressed in Phase 1 studies by AstraZeneca, following a partnership deal in August 2020. Aankondiging • Mar 10
Redx Pharma Plc Announces Committee Changes Redx announced that its Board of Directors has established a Science Committee. The Science Committee will be responsible for reviewing and assessing Redx's R&D programs and strategies, in addition to overseeing the Company's progress in achieving its R&D goals and objectives. The new Committee will be chaired by Dr. Bernhard Kirschbaum, a longstanding member of the Board with over 25 years of experience in pharmaceutical research and drug development. The Committee will also consist of Chief Executive Officer, Lisa Anson and Non-Executive Director, Dr. Rob Scott as members. As a result of his new responsibilities, Dr. Kirschbaum will step down from his role as Chair of the Remuneration Committee, but will remain a member of this committee. The Board has appointed Sarah Gordon Wild as the new Chair of the Remuneration Committee. Sarah has extensive experience in the biotechnology sector and capital markets, including over 20 years as a senior biotechnology/healthcare analyst on Wall Street. Dr. Kirschbaum will also step down from his role as a committee member on the Audit Committee, and will be replaced by Dr. Rob Scott. The changes are all effective immediately. Aankondiging • Feb 12
Redx Pharma Plc, Annual General Meeting, Mar 08, 2022 Redx Pharma Plc, Annual General Meeting, Mar 08, 2022, at 11:00 Coordinated Universal Time. Location: 85 Gresham Street London EC2V 7NQ London United Kingdom Board Change • Feb 02
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Non-Executive Director Rob Donald Scott was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Jan 28
Full year 2021 earnings: EPS in line with expectations, revenues disappoint Full year 2021 results: UK£0.084 loss per share (down from UK£0.054 loss in FY 2020). Revenue: UK£10.0m (up 77% from FY 2020). Net loss: UK£21.6m (loss widened 134% from FY 2020). Revenue missed analyst estimates by 11%. Over the next year, revenue is forecast to grow 20%, compared to a 7.0% growth forecast for the pharmaceuticals industry in Germany. Reported Earnings • Jun 10
First half 2021 earnings released: UK£0.053 loss per share (vs UK£0.027 loss in 1H 2020) The company reported a mediocre first half result with increased losses and weaker control over costs, although revenues improved. First half 2021 results: Revenue: UK£2.10m (up 79% from 1H 2020). Net loss: UK£12.7m (loss widened 219% from 1H 2020). Executive Departure • Jun 09
Non-Executive Chairman Iain Ross has left the company On the 1st of June, Iain Ross' tenure as Non-Executive Chairman ended after 4.1 years in the role. As of March 2021, Iain still personally held 251.00k shares (€216k worth at the time). A total of 2 executives have left over the last 12 months. The current median tenure of the management team is less than a year, which is considered inexperienced in the Simply Wall St Risk Model. Aankondiging • Jun 03
Redx Pharma Announces First Subject Dosed in Phase 1 Study with Lead Fibrosis Candidate RXC007, a ROCK2 Selective Inhibitor Redx Pharma Plc announced that the first subject has been dosed in a Phase 1 study in healthy volunteers evaluating the Company's lead fibrosis drug candidate RXC007, a Rho Associated Coiled-Coil Containing Protein Kinase 2 (ROCK2) selective inhibitor. The primary objective of this first-in-human study is to evaluate the safety profile of this orally bioavailable, small molecule. Results from the study are expected to be available in H1 2022. ROCK2 is a biologically validated target that has been shown to sit at a nodal point in a cell signaling pathway, thought to be central to fibrosis. As a selective ROCK2 inhibitor, RXC007 has the potential to treat several fibrotic diseases and has demonstrated robust anti-fibrotic effects in a range of industry-standard in vivo preclinical models. It is the Company's intention to clinically evaluate RXC007 initially as a treatment for idiopathic pulmonary fibrosis (IPF), a severe and life-threatening chronic lung condition, with limited treatment options, which is estimated to affect 170,000(1) patients globally. IPF has an addressable market opportunity estimated to be worth $3.6 billion by 2029. Phase 1 clinical study overview: The Phase 1, single centre, open label, adaptive clinical study will evaluate single and multiple ascending doses of RXC007, administered as an oral capsule once daily, to cohorts of healthy volunteers. The primary objective of the study is to evaluate the safety and tolerability of RXC007. Secondary objectives include characterising the pharmacokinetic profile. Headline results from the study are expected to be available in 2022, and will be used to inform a planned Phase 2 programme evaluating RXC007 as a treatment in IPF patients. Aankondiging • Mar 04
Redx Pharma Announce Mead Will Step Down from the Board Redx Pharma announced that Mead will step down from the Board with immediate effect and will cease to be a Director of the company. Going forward, the Board will therefore consist of five non-executive directors and one executive director, the CEO. Finally on a personal basis I would like to thank James for his contribution to the Board over the last two years, and his ongoing commitment as a member of the executive management team going forward. Aankondiging • Mar 03
Redx Pharma plc Announces Search for A US Based Chief Financial Officer Has Been Initiated Redx Pharma Plc announced a search for a US based Chief Financial Officer has been initiated. James Mead will continue in his role as Chief Financial Officer until a new appointment has been made at which point Dr. Mead will assume the role of Chief Operating Officer. In conjunction with these changes, Dr. Mead will step down from the Board with immediate effect and will cease to be a Director of the Company. Executive Departure • Mar 03
Chief Medical Officer has left the company On the 1st of March, Andrew Saunders' tenure as Chief Medical Officer ended after 3.1 years in the role. We don't have any record of a personal shareholding under Andrew's name. Andrew is the only executive to leave the company over the last 12 months. Aankondiging • Feb 06
Redx Pharma Plc, Annual General Meeting, Mar 02, 2021 Redx Pharma Plc, Annual General Meeting, Mar 02, 2021, at 11:00 Coordinated Universal Time. Location: Block 33 Mereside, Alderley Park Macclesfield United Kingdom Reported Earnings • Jan 28
Full year 2020 earnings released The company reported a mediocre full year result with increased losses and weaker control over costs, although revenues improved. Full year 2020 results: Revenue: UK£5.69m (up 82% from FY 2019). Net loss: UK£9.21m (loss widened 113% from FY 2019). Analyst Estimate Surprise Post Earnings • Jan 28
Revenue misses expectations Revenue missed analyst estimates by 55%. Over the next year, revenue is forecast to grow 82%, compared to a 2.4% growth forecast for the Pharmaceuticals industry in Germany. 