Ankündigung • Jun 18
GENinCode Plc, Annual General Meeting, Jul 01, 2026 GENinCode Plc, Annual General Meeting, Jul 01, 2026. Location: the offices of cavendish capital markets, one bartholomew close, ec1a 7bl, london United Kingdom New Risk • Jun 10
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 British stocks, typically moving 12% 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 Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings have declined by 14% per year over the past 5 years. Shareholders have been substantially diluted in the past year (162% increase in shares outstanding). Market cap is less than US$10m (UK£6.78m market cap, or US$9.06m). Minor Risks Currently unprofitable and not forecast to become profitable next year (UK£5.0m net loss next year). Revenue is less than US$5m (UK£3.1m revenue, or US$4.1m). Reported Earnings • Jun 09
Full year 2025 earnings: EPS and revenues miss analyst expectations Full year 2025 results: UK£0.021 loss per share. Revenue: UK£3.08m (up 14% from FY 2024). Net loss: UK£5.71m (loss widened 29% from FY 2024). Revenue missed analyst estimates by 1.1%. Earnings per share (EPS) also missed analyst estimates by 14%. Ankündigung • May 23
GENinCode Plc to Report Fiscal Year 2025 Results on May 22, 2026 GENinCode Plc announced that they will report fiscal year 2025 results at 8:00 AM, GMT Standard Time on May 22, 2026 Ankündigung • May 22
GENinCode Plc to Report Fiscal Year 2025 Results on Jun 08, 2026 GENinCode Plc announced that they will report fiscal year 2025 results at 8:00 AM, GMT Standard Time on Jun 08, 2026 New Risk • Apr 19
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 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 Share price has been highly volatile over the past 3 months (15% average weekly change). Shareholders have been substantially diluted in the past year (162% increase in shares outstanding). Minor Risks Latest financial reports are more than 6 months old (reported June 2025 fiscal period end). Currently unprofitable and not forecast to become profitable next year (UK£4.2m net loss next year). Revenue is less than US$5m (UK£2.9m revenue, or US$3.9m). Market cap is less than US$100m (UK£9.04m market cap, or US$12.2m). Ankündigung • Jan 27
GENinCode Plc has completed a Follow-on Equity Offering in the amount of £0.200141 million. GENinCode Plc has completed a Follow-on Equity Offering in the amount of £0.200141 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 20,014,095
Price\Range: £0.01 Ankündigung • Oct 28
GENinCode plc Announces the Publication of Major Clinical Study in JACC: Advances Evaluating the Company's Cardio InCode-Score®? Polygenic Risk Score for Coronary Heart Disease GENinCode Plc announced the publication of a major clinical study in JACC: Advances evaluating the Company's CARDIO inCode-Score®? Polygenic Risk Score ("PRS") for coronary heart disease ("CHD"). JACC: Advances, a medical journal which is part of the Journal of the American College of Cardiology (JACC), specifically focuses on the latest research in cardiovascular medicine including new treatments, technologies and scientific discoveries in Cardiology leading to better clinical practices in the medical field. The peer-reviewed study, titled "Joint Consideration of LDL-C and Polygenic Risk for Coronary Heart Disease Risk Assessment", was conducted by researchers at Kaiser Permanente's Department of Research and Department of Cardiology in San Francisco, California, USA. The Kaiser Permanente study followed over 47,000 individuals of diverse ancestry for 14 years, analysing the relationship between low-density lipoprotein cholesterol (LDL-C) and polygenic risk for coronary heart disease. Participants were assessed for the incidence of CHD events including myocardial infarction (heart attack). The CARDIO inCode-Score(®? PRS was used to quantify each participant's inherited risk of CHD based on genetic variation across the genome. The study examined whether the effect of LDL-cholesterol on CHD risk was modified by an individual's underlying genetic risk. The results demonstrated that genetic risk significantly influences the relationship between LDL-cholesterol and coronary heart disease, with the combination of elevated LDL-C and high PRS conferring substantially greater risk. Individuals with high polygenic risk experienced a 75% increase in CHD risk at LDL-C levels as low as 100 mg/dL (2.6 mmol/L) (Hazard Ratio: 1.75); The combination of a high PRS and LDL-C of 190 mg/dL (4.9 mmol/L) or higher was associated with a greater than 3.5-fold increase in CHD risk, comparable to the risk observed in patients with heterozygous familial hypercholesterolemia (FH), a well-established genetic condition conferring very high cardiovascular risk. These findings confirm that polygenic risk acts as a powerful modifier of LDL-cholesterol-related CHD risk, supporting its use in clinical decision-making and preventive care. Clinical and Preventive Implications This study underscores the critical role that integrating genetic data with clinical assessments can play in revolutionising cardiovascular risk stratification and prevention and guide earlier intervention in at-risk populations. Individuals with high genetic risk may benefit from more proactive lipid management and lifestyle or therapeutic intervention, even at LDL-C levels traditionally considered low or moderate. By integrating polygenic risk assessment into existing clinical pathways, healthcare providers can more accurately identify individuals at heightened lifetime risk of CHD and personalise prevention strategies. This can also reduce the incidence of severe cardiovascular events, such as heart attacks and strokes, and potentially mitigate the economic costs associated with long-term heart disease care. This approach can be seen as a significant step toward improving public health outcomes, particularly in addressing the global burden of cardiovascular disease. Dr. Richard Kovacs, Q.E. and Sally Russell Professor of Cardiology at the Indiana University School of Medicine and Chief Medical Officer of the American College of cardiology and Past President of the American College of Cardology said: " These results provide further compelling clinical evidence for the inclusion of polygenic risk scores (PRS) in conjunction with clinical risk for improved risk assessment of CHD. The polygenic risk score is especially important in relation to patients clinically classified at borderline/intermediate risk and younger patients with a family history of CHD. The recent scientific statements and acknowledgment of the value of PRS by the American College of Cardiology and American Heart Association is also welcome". Reported Earnings • Oct 06
First half 2025 earnings released: UK£0.012 loss per share (vs UK£0.014 loss in 1H 2024) First half 2025 results: UK£0.012 loss per share. Revenue: UK£1.60m (up 15% from 1H 2024). Net loss: UK£2.96m (loss widened 22% from 1H 2024). Ankündigung • Sep 05
GENinCode Plc to Report First Half, 2025 Results on Sep 30, 2025 GENinCode Plc announced that they will report first half, 2025 results on Sep 30, 2025 Ankündigung • Jul 07
GENinCode Plc Announces an Update on Its Food and Drug Administration De Novo Submission GENinCode Plc announced an update on its Food and Drug Administration (FDA) De Novo submission. In response to a request by the Company for a Supervisory Review, the FDA recently provided a review of its April 2025 assessment. While the number of the outstanding deficiencies has been reduced, the review upheld the FDA's prior view that there remains certain outstanding elements, including further information in relation to clinical validation. With the feedback from the Supervisory Review, the Board remains of the view that there is a path forward to provide the further information to resolve these deficiencies to obtain De Novo classification. Discussions with the FDA have been productive with the outstanding deficiencies reducing. The Board does not believe that there are any elements that it cannot address, however there can be no certainty that the information provided will be sufficient. The Company has arranged further ongoing clarifictory discussions with the FDA and will provide a further update if this provides additional information. Ankündigung • Jun 13
GENinCode Plc, Annual General Meeting, Jun 30, 2025 GENinCode Plc, Annual General Meeting, Jun 30, 2025. Location: the offices of cavendish capital markets, one bartholomew close, ec1a 7bl, london United Kingdom Reported Earnings • Jun 04
Full year 2024 earnings released: UK£0.025 loss per share (vs UK£0.073 loss in FY 2023) Full year 2024 results: UK£0.025 loss per share (improved from UK£0.073 loss in FY 2023). Revenue: UK£2.70m (up 25% from FY 2023). Net loss: UK£4.43m (loss narrowed 37% from FY 2023). Over the last 3 years on average, earnings per share has increased by 20% per year but the company’s share price has fallen by 52% per year, which means it is significantly lagging earnings. Ankündigung • May 16
GENinCode Plc to Report Fiscal Year 2024 Results on Jun 04, 2025 GENinCode Plc announced that they will report fiscal year 2024 results at 8:00 AM, GMT Standard Time on Jun 04, 2025 New Risk • May 02
New major risk - Revenue and earnings growth Earnings have declined by 37% 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 (14% average weekly change). Earnings have declined by 37% per year over the past 5 years. Shareholders have been substantially diluted in the past year (62% increase in shares outstanding). Market cap is less than US$10m (UK£4.37m market cap, or US$5.81m). Minor Risks Latest financial reports are more than 6 months old (reported June 2024 fiscal period end). Revenue is less than US$5m (UK£2.6m revenue, or US$3.5m). Ankündigung • May 02
Genincode plc Announces an Update on Its Food and Drug Administration De Novo Submission GENinCode Plc announced an update on its Food and Drug Administration De Novo submission. The FDA has provided full feedback on the application and determined that there remains certain outstanding elements, including deficiencies in relation to clinical validation, that need to be addressed. The Company has initiated a Supervisory Review with the FDA to address these elements and is holding ongoing discussions and in-person meetings with the FDA to resolve these deficiencies. The Board does not believe that there are any elements that it cannot address, however there can be no certainty that the information provided will be sufficient. The Company will provide a further update at the Preliminary Results at the end of May 2025. New Risk • Apr 14
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2024. 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). Shareholders have been substantially diluted in the past year (62% increase in shares outstanding). Market cap is less than US$10m (UK£7.17m market cap, or US$9.38m). Minor Risks Latest financial reports are more than 6 months old (reported June 2024 fiscal period end). Currently unprofitable and not forecast to become profitable next year (UK£4.6m net loss next year). Revenue is less than US$5m (UK£2.6m revenue, or US$3.4m). New Risk • Mar 31
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 62% 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 (25% average weekly change). Shareholders have been substantially diluted in the past year (62% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable next year (UK£4.6m net loss next year). Revenue is less than US$5m (UK£2.6m revenue, or US$3.4m). Market cap is less than US$100m (UK£8.18m market cap, or US$10.6m). Board Change • Mar 02
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 6 experienced directors. No highly experienced directors. Independent Non-Executive Director Felix Frueh was the last director to join the board, commencing their role in 2022. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Ankündigung • Jan 23
GENinCode plc Announces Inclusion of Cardio inCode inCode in the US 2025 Clinical Lab Fee Schedule GENinCode Plc announced the inclusion of CARDIO inCode (for the polygenic risk assessment of coronary heart disease) in the US 2025 Clinical Lab Fee Schedule (CLFS) to enable reimbursement from Medicare and Medicaid across the US. The company also announces the implementation of CARDIO inCode for the prevention of coronary heart disease (CHD) in the Spanish region of Barcelona. The CARDIO inCode-Score test is being clinically adopted across leading US healthcare institutions and has now been included in the Centers for Medicare and Medicaid Services (CMS) Clinical Lab Fee Schedule (CL FS) from 2025. The CARDIO inCode test (CPT code: 0401U) price varies on a state by state basis ranging from $450 - $570 with a median price of ~ $500/test. The company is also progressing its FDA ' de novo' submission for CARDIO inCode and expects to provide an update on progress over the coming months. Following earlier CARDIO inCode test pilots across Spain, the Barcelona ministry of health has agreed to implement CARDIO inCode to improve the risk assessment of cardiovascular disease in primary care through the Barcelona Health Institute - ICS ("Institut Catala de la Salut"). Barcelona is one of 17 Spanish regions providing state based health services to prevent CHD. Out of a total Spanish population of approximately 48 million, the Barcelona region has a population of 7.7m. CARDIO inCode will be provided to patients aged between 45 to 64 years targeting those at risk of CHD estimated at up to 476,000 patients in the Barcelona region. Test volumes are expected to escalate up to approximately 1,000 patient tests through this year with volumes expanding as increasing numbers of physicians, community practices and regions are educated and onboarded for testing. The Company is also progressing pilot preparations for CARDIO inCode in other Spanish regions. GENinCode specialises in polygenic risk assessment for the prevention of CHD. CHD is the most common form of heart disease and the leading cause of death worldwide and in the United Kingdon and United States. In the UK around 7.6m people live with heart and circulatory disease, which causes 25% of all deaths annually. CHD can be reduced by identifying and treating individuals at risk, and the NHS 10 Year Plan (2019) focused on addressing CVD prevention. New Risk • Oct 23
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: UK£6.94m (US$8.97m) 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£6.1m free cash flow). Share price has been highly volatile over the past 3 months (10% average weekly change). Earnings have declined by 37% per year over the past 5 years. Shareholders have been substantially diluted in the past year (85% increase in shares outstanding). Market cap is less than US$10m (UK£6.94m market cap, or US$8.97m). Minor Risk Revenue is less than US$5m (UK£2.6m revenue, or US$3.4m). Reported Earnings • Sep 28
First half 2024 earnings released: UK£0.014 loss per share (vs UK£0.037 loss in 1H 2023) First half 2024 results: UK£0.014 loss per share (improved from UK£0.037 loss in 1H 2023). Revenue: UK£1.39m (up 46% from 1H 2023). Net loss: UK£2.43m (loss narrowed 31% from 1H 2023). Over the last 3 years on average, earnings per share has increased by 24% per year but the company’s share price has fallen by 48% per year, which means it is significantly lagging earnings. New Risk • Sep 16
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 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 Less than 1 year of cash runway based on free cash flow trend (-UK£7.5m free cash flow). Share price has been highly volatile over the past 3 months (10% average weekly change). Earnings have declined by 46% per year over the past 5 years. Shareholders have been substantially diluted in the past year (85% increase in shares outstanding). Minor Risks Latest financial reports are more than 6 months old (reported December 2023 fiscal period end). Currently unprofitable and not forecast to become profitable next year (UK£5.3m net loss next year). Revenue is less than US$5m (UK£2.2m revenue, or US$2.8m). Market cap is less than US$100m (UK£11.9m market cap, or US$15.7m). Ankündigung • Sep 09
GENinCode Plc to Report First Half, 2024 Results on Sep 25, 2024 GENinCode Plc announced that they will report first half, 2024 results on Sep 25, 2024 Ankündigung • Jun 09
GENinCode Plc, Annual General Meeting, Jun 27, 2024 GENinCode Plc, Annual General Meeting, Jun 27, 2024. Location: the offices of cavendish capital markets, one bartholomew close, ec1a 7bl, london United Kingdom New Risk • Jun 04
New major risk - Revenue and earnings growth Earnings have declined by 46% 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 Less than 1 year of cash runway based on free cash flow trend (-UK£7.5m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings have declined by 46% per year over the past 5 years. Shareholders have been substantially diluted in the past year (85% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable next year (UK£4.6m net loss next year). Revenue is less than US$5m (UK£2.2m revenue, or US$2.8m). Market cap is less than US$100m (UK£13.7m market cap, or US$17.5m). Reported Earnings • Jun 04
Full year 2023 earnings released: UK£0.07 loss per share (vs UK£0.058 loss in FY 2022) Full year 2023 results: UK£0.07 loss per share (further deteriorated from UK£0.058 loss in FY 2022). Revenue: UK£2.16m (up 51% from FY 2022). Net loss: UK£7.02m (loss widened 26% from FY 2022). Ankündigung • May 24
GENinCode Plc to Report Fiscal Year 2023 Results on Jun 03, 2024 GENinCode Plc announced that they will report fiscal year 2023 results on Jun 03, 2024 New Risk • Apr 07
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 (16% average weekly change). Shareholders have been substantially diluted in the past year (85% increase in shares outstanding). Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Currently unprofitable and not forecast to become profitable next year (UK£5.6m net loss next year). Revenue is less than US$5m (UK£1.7m revenue, or US$2.2m). Market cap is less than US$100m (UK£16.6m market cap, or US$21.0m). Ankündigung • Apr 04
GENinCode Plc Announces Publication by the American Journal of Preventive Cardiology of A Study on 'Polygenic Risk and Incident Heart Disease in a Large Multiethnic Cohort GENinCode Plc announced the publication by the American Journal of Preventive Cardiology of a study on 'Polygenic Risk and Incident Heart Disease in a large multiethnic cohort'. The Kaiser Permanente Division of Research study investigated more than 63,000 adult individuals with no history of Coronary Heart Disease (CHD) who are part of the Kaiser Permanente Northern California Genetic Epidemiology Resource in Adult Health and Aging (GERA) multi-ethnic cohort. The GERA cohort followed the membership over an average of 14 years, using CARDIO inCode-Score® to assess the polygenic risk of CHD and future incidence of risk of CHD. The study found that CARDIO inCode-Score®can identify individualsatthe highestrisk ofCHD. These individuals shouldthenbe prioritised for lifestyle adviceand where appropriate therapeutic interventionas they will benefit the most. Previous data with CARDIO inCode-Score®has shown that, for individuals with a high genetic risk, a favourable lifestyle is associated with a 52% lower rate of CHD compared with an unfavourable lifestyle. CHD 'event' includes:non-fatal AMI, angina or coronary atherosclerosis, coronary revascularisation procedures (coronary by-pass or percutaneous intervention) or CHD death. The study underlines the need for 'polygenic risk score' lifetime risk assessment in conjunction with traditional clinical risk assessment to optimise preventive care strategies to lower the future risk of CHD. Polygenic risk assessment can be undertaken in younger people, before conventional clinical risk factors (such as high blood pressure, diabetes etc.) have developed and can be combined with conventional risk scoring in older people. In this way clinicians can better identify those most likely to benefit from lifestyle and therapeutic intervention.GENinCode is commencing its commercialisation ofCARDIO inCode-Score®(or CIC-SCORE) with leading healthcare institutions in the United States to provide an improved estimation of an individual's risk of heart attack over their lifetime. CIC-Score is being delivered from the GENinCode CLIA and CAP approved laboratory in Irvine, California. The Company filed its CIC-Score 'De Novo' medical device submission with the FDA at the end of last year. The Company continues to progress its submission for FDA approval of the CIC-SCORE medical device to enable the scale up and processing by labs across the United States. New Risk • Mar 22
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 British stocks, typically moving 12% 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 Share price has been highly volatile over the past 3 months (12% average weekly change). Shareholders have been substantially diluted in the past year (85% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable next year (UK£5.6m net loss next year). Revenue is less than US$5m (UK£1.7m revenue, or US$2.2m). Market cap is less than US$100m (UK£8.49m market cap, or US$10.7m). Ankündigung • Dec 28
GENinCode Plc has completed a Follow-on Equity Offering in the amount of £4.057378 million. GENinCode Plc has completed a Follow-on Equity Offering in the amount of £4.057378 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 67,576,000
Price\Range: £0.05
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 12,424,000
Price\Range: £0.05
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,147,560
Price\Range: £0.05
Transaction Features: Rights Offering; Subsequent Direct Listing Ankündigung • Nov 29
GENinCode plc Agrees with the Food and Drug Administration to Create New Regulatory Class for Polygenic Risk scores and Transition Its Premarket Notification 510(K) Submission to A De Novo Pathway GENinCode Plc announced it has agreed with the Food and Drug Administration (FDA) to create a new regulatory class for polygenic risk scores and transition its premarket notification 510(k) submission to a De Novo submission. The new regulatory class clearance of CARDIO inCode will enable GENinCode to commercially advance US national distribution of the CARDIO inCode-Score polygenic test kit (medical device) for the risk assessment and prevention of Coronary Heart Disease ("CHD"). Following the CARDIO inCode- Score 510(k) medical device submission in August 2023, the FDA has reviewed the submission and recently noted CARDIO inCode-Score's 'first in class' position and the deep clinical evidence for polygenic risk assessment of CHD. Based on these factors and the novel position of CARDIO inCode-Score, the FDA has requested the Company to transition to a De Novo pathway for market approval. The crossover to a De Novo pathway enables the Company to work with the FDA to establish a new polygenic regulatory class for the CARDIO inCode- score medical device based on its favourable benefit-risk profile and associated special controls thereby setting a new regulatory standard for future polygenic tests in this class. Following the FDA request, the Company has now submitted its De Novo submission for market clearance and expects a timeline to clearance broadly in line with earlier the earlier 510(k) submission forecasts of late first quarter/early second quarter 2024. CARDIO inCode-Score or CIC-SCORE is an in-vitro diagnostic test used to assess an individual's polygenic risk of CHD based on DNA analysis. Published clinical evidence amassed over the past 15 years shows that the test when combined with traditional clinical risk assessment, provides a comprehensive risk assessment of CHD for use in primary preventive care. GENinCode processes and delivers the CIC-SCORE test results to physicians via its online 'SITAB' cloud based reporting system. The CIC-SCORE test addresses the well-recognised need to improve the CHD standard of care by providing a genetic (polygenic) risk assessment for CHD, thereby improving preventive care, patient management, and personalised treatment. GENinCode has commenced Early Access Programs for CARDIO inCode-Score with leading institutions in the United States to provide an improved estimation of an individual's risk of heart attack over their lifetime. The test is currently being delivered from the GENinCode CLIA and CAP approved laboratory in Irvine, California. New Risk • Oct 10
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: UK£7.90m (US$9.71m) 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£7.1m free cash flow). Earnings are forecast to decline by an average of 12% per year for the foreseeable future. Market cap is less than US$10m (UK£7.90m market cap, or US$9.71m). Minor Risks Currently unprofitable and not forecast to become profitable next year (UK£7.5m net loss next year). Share price has been volatile over the past 3 months (7.5% average weekly change). Revenue is less than US$5m (UK£1.7m revenue, or US$2.1m). Reported Earnings • Sep 22
First half 2023 earnings released: UK£0.037 loss per share (vs UK£0.024 loss in 1H 2022) First half 2023 results: UK£0.037 loss per share (further deteriorated from UK£0.024 loss in 1H 2022). Revenue: UK£950.0k (up 43% from 1H 2022). Net loss: UK£3.50m (loss widened 50% from 1H 2022). Revenue is forecast to grow 57% p.a. on average during the next 3 years, compared to a 5.9% growth forecast for the Healthcare industry in the United Kingdom. Ankündigung • Sep 22
GENinCode Plc Provides Revenue Guidance for the Second Half of 2023 GENinCode Plc provided revenue guidance for the second half of 2023. Over the second half of 2023 the company will continue to strengthen revenues across its UK and EU business and transition its US Early Access Program to start commercially selling CARDIO inCode-Score (CIC-SCORE) and LIPID inCode. The company is focused on scale-up and revenue growth across its core EU, UK and US markets, gaining FDA regulatory approval and reimbursement coverage for CARDIO inCode-Score whilst taking advantage of US reimbursement coverage for its familial hypercholesterolemia test LIPID inCode. Over the remainder of this financial year, the company expects to complete the following key deliverables: Significant growth in year-on-year revenues. Successful delivery of US Early Access Programs and first US revenues. Ankündigung • Sep 14
GENinCode Plc to Report First Half, 2023 Results on Sep 20, 2023 GENinCode Plc announced that they will report first half, 2023 results on Sep 20, 2023 Ankündigung • Sep 01
Genincode plc Announces CARDIO inCode study on risk of incident Coronary Heart Disease GENinCode Plc announced the presentation by Kaiser Permanente, US on the ' Utility of the CARDIO inCode-Score®? CHD polygenic risk score for incident coronary heart disease interplay with lifestyle in a multi-ethnic cohort of more than 60,000 individuals'. The presentation was made at the Annual Meeting of the European Society of Cardiologists Congress over 25-28 August 2023 in Amsterdam. The study investigated over 60,000 adult individuals with no history of Coronary Heart Disease (CHD) from the Genetic Epidemiology Resource in Adult Health and Aging (GERA) multi-ethnic cohort of the Kaiser Permanente Medical Care plan of Northern California, USA. The GERA cohort followed the membership over an average of 14 years, using CARDIO inCode-Score to assess the polygenic risk of CHD, interplay with lifestyle and the incidence of CHD. Other recently announced news As previously announced, GENinCode is commencing Early Access Programs for CIC-SCORE (or CARDIO inCode- Score®?) with leading healthcare institutions in the United States to provide an improved estimation of an individual's risk of heart attack over their lifetime. CIC-Score is now being commercially delivered from the GENinCode CLIA and CAP approved laboratory in Irvine, California. As also announced, the Company has recently filed its CIC-Score pre-market notifification (510k) medical device filing with the FDA. The Company expects to receive FDA approval for the CIC-SCORE medical device over the next 6 months enabling scale up and processing by CLIA labs across the United States. In the UK around 7.6m people live with heart and circulatory disease, which causes 25% of all deaths annually. CVD can be reduced by identifying and treating individuals at risk, and the NHS 10 Year Plan (2019) sets out to address CVD prevention. Ankündigung • Aug 17
GENinCode plc Files its Premarket Notification (510k) with the Food and Drug Administration to Expand Its US Commercial Distribution of the Cardio InCode-Score Polygenic Test for the Risk Assessment and Prevention of Coronary Heart Disease GENinCode Plc announced it has filed its Premarket Notification (510k) with the Food and Drug Administration (FDA) to expand its US commercial distribution of the CARDIO inCode-Score ("CIC-SCORE") polygenic test for the risk assessment and prevention of Coronary Heart Disease ("CHD"). CIC-SCORE is a in-vitro diagnostic test used to assess an individual's polygenic risk of CHD based on DNA analysis. The test is based on published clinical evidence amassed over the past 15 years which combined with traditional clinical risk provides a comprehensive risk assessment of CHD for use in primary preventative care. GENinCode processes and delivers the CIC-SCORE test results to physicians via its online 'SITAB' cloud based reporting system. The CIC-SCORE test addresses the well-recognised need to improve the CHD standard of care by providing a step change in patient risk assessment for CHD thereby improving preventative care, patient management, and personalised treatment. GENinCode has commenced Early Access Programs for CIC-SCORE with leading institutions in the United States to provide an improved estimation of an individual's risk of heart attack over their lifetime. The test is currently being delivered from the GENinCode CLIA approved laboratory in Irvine, California. The Company expects to receive FDA approval of the premarket notification for the CIC-SCORE kit/medical device over the next 6 months enabling scale up and processing by CLIA labs across the United States. The Company also announces that it has received the College of American Pathologist ("CAP") laboratory accreditation for the CIC-SCore test delivered from the Company's US laboratory based in Irvine, California. This follows receipt of California State Licensing and CLIA approval earlier this year. The 510k filing follows the recently announced CPT PLA code (0401U) for CIC-SCORE which was approved and published by the AMA CPT Editorial Panel. A payment rate for the new code will be established for Medicare patients through the Clinical Lab Fee Schedule ("CLFS") Annual Public Meetings with a pricing decision on CIC-SCORE expected in October. This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014, as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018. Identifying those at highest risk of CVDs and ensuring they receive appropriate treatment can prevent premature deaths. Access to noncommunicable disease medicines and basic health technologies in all primary health care facilities is essential to ensure that those in need receive treatment and counselling. The current standard of care for assessing cardiovascular risk is primarily based on traditional clinical risk factors such as age, sex, smoking, body mass, blood pressure and cholesterol levels from which individuals are categorised as being at low, moderate or high risk of a CVD event. This categorisation is imperfect as CVD events frequently occur in those thought to be at low or moderate risk. The size of the populations at low or moderate risk are much larger than those at high or very high risk so whilst the relative risk of a CVD event may be small, the absolute number of CVD events in low and moderate risk populations is much greater than the number of events in higher risk categories. Clinicians have for many years recognised the importance of prior CVD events within the families of their patients because genetic factors contribute to the development of atherosclerosis and a patient's family history has become a surrogate for their inherited genetic risk. In recent years, with the advances of genomics, it has proved possible to add genetic profiling to conventional CVD risk factors, the combination of the two (genetics and conventional clinical risk factors) enhancing the predictive capability of patient risk thereby resulting in a personalised and preventative approach to CVD. New Risk • Jul 03
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -UK£4.6m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. 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£4.6m free cash flow). Earnings are forecast to decline by an average of 18% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (UK£8.0m net loss in 2 years). Revenue is less than US$5m (UK£1.4m revenue, or US$1.8m). Market cap is less than US$100m (UK£11.5m market cap, or US$14.6m). Ankündigung • Jun 09
GENinCode Plc, Annual General Meeting, Jun 30, 2023 GENinCode Plc, Annual General Meeting, Jun 30, 2023, at 13:00 Coordinated Universal Time. Location: the offices of Cenkos Securities plc 6,7,8 Tokenhouse Yard, London EC2R 7ASon London United Kingdom Reported Earnings • Jun 07
Full year 2022 earnings: Revenues exceed analyst expectations Full year 2022 results: Revenue: UK£1.43m (up 24% from FY 2021). Net loss: UK£5.56m (loss widened 34% from FY 2021). Revenue exceeded analyst estimates by 3.2%. Revenue is forecast to grow 51% p.a. on average during the next 3 years, compared to a 5.3% growth forecast for the Healthcare industry in the United Kingdom. Ankündigung • Jun 05
GENinCode Plc to Report Fiscal Year 2022 Results on Jun 06, 2023 GENinCode Plc announced that they will report fiscal year 2022 results on Jun 06, 2023 Ankündigung • Jan 04
Genincode plc Announces Approval of California State License and Clia Certification Opens Us Market GENinCode Plc announces California state licensing approval and CLIA certification of its Irvine laboratory in California, enabling the provision of its products for the risk assessment of CVD to patients across 49 states in the United States. The approval of the California state license by the California Department of Public Health and CLIA certification from the Centers for Medicare and Medicaid Services (CMS) marks a major milestone in the commercialisation of the Company's 'first in class' polygenic CVD products CARDIO inCode®and LIPID inCode®, which can now to be sold across the US and serviced from the Company's California CLIA lab. CARDIO inCode®measures an individuals inherited genetic risk of coronary heart disease with the complementary FDA 510K submission for a CARDIO inCode®kit (for use by other CLIA labs) to be filed shortly. LIPID inCode®measures an individuals inherited genetic inability to metabolise LDL-C cholesterol (LDL-C is often referred to as 'bad cholesterol') giving rise to accelerated onset of heart disease. CARDIO inCode®and LIPID inCode®are now being prepared for entry into Early Access Programs with US revenue growth forecast from 2023. CARDIO inCode®measures the coronary genetic risk of a patient suffering a heart attack or cardiovascular event. This new genetic information allows physicians to gain insight to a patient's coronary genetic risk score allowing more effective and earlier treatment to prevent heart disease. Physicians can now advise patients on their genetic risk of a coronary event and establish necessary changes to their lifestyle (e.g. reducing smoking, drinking or improving eating habits) as well as prescribing therapeutic treatment (e.g. statins, PCSK9i or other cholesterol lowering drugs) to prevent heart disease. Board Change • Nov 16
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Non-Executive Director Felix Frueh 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 • Sep 27
First half 2022 earnings released: UK£0.027 loss per share (vs UK£0.088 loss in 1H 2021) First half 2022 results: UK£0.027 loss per share. Revenue: UK£664.0k (up 11% from 1H 2021). Net loss: UK£2.33m (loss widened 131% from 1H 2021). Revenue is forecast to grow 87% p.a. on average during the next 2 years, compared to a 5.5% growth forecast for the Healthcare industry in the United Kingdom. Ankündigung • May 24
GENinCode plc, Annual General Meeting, Jun 23, 2022 GENinCode plc, Annual General Meeting, Jun 23, 2022, at 13:00 Coordinated Universal Time. Location: Walbrook PR,75 King William Street London United Kingdom Reported Earnings • May 19
Full year 2021 earnings: Revenues miss analyst expectations Full year 2021 results: Revenue: UK£1.15m (up 20% from FY 2020). Net loss: UK£4.14m (loss widened 255% from FY 2020). Revenue missed analyst estimates by 6.9%. Over the next year, revenue is forecast to grow 170%, compared to a 60% growth forecast for the industry in the United Kingdom. Ankündigung • May 03
GENinCode plc to Report Fiscal Year 2021 Results on May 17, 2022 GENinCode plc announced that they will report fiscal year 2021 results on May 17, 2022 Board Change • Apr 27
Less than half of directors are independent There are 5 new directors who have joined the board in the last 3 years. Of these new board members, 3 were independent directors. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Non-Executive Director Huon Gray was the last independent director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Board Change • Apr 13
Less than half of directors are independent There are 5 new directors who have joined the board in the last 3 years. Of these new board members, 3 were independent directors. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Non-Executive Director Huon Gray was the last independent director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Ankündigung • Apr 06
Genincode plc Announces the Appointment of Felix Frueh, as Non-Executive Director GENinCode Plc announced the appointment to the Board of Felix Frueh, PhD ("Felix") as a Non-Executive Director. Felix is a senior life sciences executive with in-depth expertise in corporate, regulatory, and commercialisation strategies, with a particular focus on precision medicine. He has over 25 years of experience setting scientific and corporate strategy in precision medicine, and has founded several start-ups in the diagnostics and pharmaceutical sectors. He has worked in the regulatory space for 18 years, including five years working with the FDA. In addition to his FDA career, Felix oversaw the creation and operations of the world's next-generation, Clinical Laboratory Improvement Amendments (CLIA)-certified, whole human genome sequencing laboratory, as the Chief Scientific Officer of Human Longevity (HLI). Prior to this, he served as President of Medco Research Institute, Research Director for Pharmacogenetics of Transgenomic, and Assistant Director of Protogene Laboratories. He is Founder and Executive Partner of Opus Three, Co-Founder and Partner of Profound Ventures, and Co-Founder and Chief Scientific Officer of Selva Therapeutics. He also co-founded and formerly served as the Chief Executive Officer of Intellos Health. Ankündigung • Feb 22
Genincode plc Appoints Huon Gray Cbe as an Independent Non-Executive Director GENinCode plc announced on 21 January 2022, Professor Huon Gray CBE has been appointed to the board as an independent non-executive director with immediate effect. Ankündigung • Feb 08
GENinCode plc Provides Positive Results for Lipid InCode in NHS Study GENinCode plc announced the successful completion of its NHS clinical study and positive results for its Lipid inCode® test for hypercholesterolemia including Familial Hypercholesterolemia, undertaken at Royal Brompton and Harefield Hospitals, recently merged with Guy's and St Thomas' NHS Foundation Trust. The peer reviewed study, which has been published in Global Cardiology Science and Practice, involved DNA samples from 40 index cases who had been referred for FH testing in an ISO15189-accredited NHS genetic screening service. These samples were then retrospectively tested using the Lipid inCode® assay with the results compared with those from the initial NHS testing. The study concluded that "the Lipid inCode® diagnostic test can be undertaken with rapid turnaround and gave the same results as those reported by standard NHS genetic laboratory testing." This is expected to increase diagnostic efficiency and support timely clinical management. Furthermore, the study found that Lipid inCode® offers additional genetic information such as a polygenic risk score for hypercholesterolemia, pharmacogenomic testing for statin intolerance, and genetic predisposition to raised Lp, an important independent cardiovascular risk factor. Lipid inCode® also provides a coronary Genetic Risk Score which indicates the genetic contribution to an individual's overall risk of future coronary heart disease events, based on the genetic variants analysed. In the UK around 7.6m people are living with heart and circulatory disease causing 25% of all deaths annually in the UK. Cardiovascular disease can be reduced by diagnosing and treating individuals at risk, and the NHS 10 Year Plan (2019) sets out significant ambitions to address the prevention of CVD, including identifying individuals with hypercholesterolemia and particularly those with FH. Lipid inCode offers genetic testing for the causes of high cholesterol, with rapid results and a comprehensive report to clinicians. Lipid inCode® will be offered at a reduced cost to the NHS to help support the NHS meet its declared ambition to detect 25% of people with FH by 2024. Familial Hypercholesterolemia is an inherited monogenic condition which affects an individual's ability to regulate and remove cholesterol from their blood. FH affects approximately 1 in 250 people in the UK population and globally. The NHS Long Term Plan sets out to expand access to genetic testing for FH, which causes early heart attacks and sudden cardiac death. Individuals suffering with FH have a higher risk of heart disease and death at a younger age. For individuals suffering with FH it is important to lower their cholesterol to healthy levels as early as possible, often requiring medicines such as statins or more aggressive treatment to help better control cholesterol levels. GENinCode specialises in polygenic assessment to identify those at risk of developing CVD, with the aim of preventing future cardiovascular events. CVD is a broad disease classification which encompasses conditions such as coronary artery disease, cerebrovascular disease, peripheral vascular disease and venous thromboembolism. CVD is the leading cause of death and disability worldwide accounting for one in every four deaths in the United States. According to the US National Institutes of Health (NIH), by 2030, the global cost of CVD is set to rise to US$1,044 billion, from approximately US$863 billion in 2010, and is both a major health issue and global economic burden. GENinCode and RB&H have a shared vision to assist clinicians and inform patients in interpreting cardiovascular risk, and to improve public health using the predictive capability of genomics. High genetic risk patients are assisted in making lifestyle choices and can receive targeted treatment to improve outcomes.Over the past 15 years GENinCode has made a substantial investment in its research, bioinformatic data, technology, and product development to assess disease risk, in order to help clinicians and patients prevent the onset of CVD. Ankündigung • Jan 12
GENinCode Plc Announces FDA Pre-Submission for Cardio inCode-Score GENinCode Plc announces the filing of its Pre-Submission for Cardio inCode-SCORE with the Food and Drug Administration (FDA). Cardio inCode-SCORE is an in-vitro diagnostic test which assesses an individual's combined genetic and clinical risk to predict and prevent cardiovascular disease. Following extensive exchange of information and constructive discussions with the FDA, GENinCode has been invited by the FDA to file its Pre-Submission for Cardio inCode-SCORE. This marks the commencement of the regulatory pathway for US market approval, which is anticipated later this year. The FDA views Pre-Submission as a structured process for managing and tracking interactions between manufacturers and the FDA about the application for approval or clearance, prior to final submission. It is an interactive process designed to give the opportunity to obtain FDA feedback on the application with the goal of making the end submission process more efficient. The Cardio inCode-SCORE test assesses an individual's inherited genetic (DNA) risk of cardiovascular disease together with their clinical risk to provide a comprehensive risk assessment of CVD for use in primary preventative care. It also addresses the well-recognised need for improvement in CVD standard of care practices. The test provides a greatly improved estimation of an individual's risk of a CVD event (e.g. heart attack) particularly within a 10-year period following the test. Cardio inCode-SCORE provides a step change in patient risk assessment for CVD thereby providing a major improvement in preventative care, patient management, diagnosis, and personalised treatment. Board Change • Nov 29
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 Bill Rhodes was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Executive Departure • Nov 29
Independent Non-Executive Director David Evans has left the company On the 29th of November, David Evans' tenure as Independent Non-Executive Director ended after 1.6 years in the role. As of September 2021, David still personally held 3.32m shares (UK£1.3m worth at the time). David is the only executive to leave the company over the last 12 months. Ankündigung • Nov 27
GENinCode plc (AIM:GENI) acquired Assets of Ferrer inCode and Gendiag.exe Businesses from Grupo Ferrer Internacional, S.A. GENinCode plc (AIM:GENI) acquired Assets of Ferrer inCode and Gendiag.exe Businesses from Grupo Ferrer Internacional, S.A. on September 2018. The technology and products acquired included Cardio inCode, Lipid inCode, Thrombo inCode and Sudd inCode.
GENinCode plc (AIM:GENI) completed the acquisition of Assets of Ferrer inCode and Gendiag.exe Businesses from Grupo Ferrer Internacional, S.A. on September 2018. Ankündigung • Jul 23
GENinCode Plc has completed an IPO in the amount of £17.000001 million. GENinCode Plc has completed an IPO in the amount of £17.000001 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 38,636,366
Price\Range: £0.44
Transaction Features: Direct Listing; Regulation S; Sponsor Backed Offering 
