Announcement • Jun 25
Sareum Holdings PLC Publishes Phase 1 Clinical Data on SDC-1801 in British Journal Of Clinical Pharmacology Sareum Holdings PLC announced the publication of the full dataset from the Phase 1 clinical trial of its lead asset, SDC-1801, in the peer-reviewed British Journal of Clinical Pharmacology. The paper, titled 'First-in-human, phase I, randomised, safety, pharmacokinetic, food-effect, and pharmacodynamic study of a tyrosine kinase 2/janus kinase 1 inhibitor, SDC-1801', presents the findings from a randomised, double-blind, placebo-controlled study conducted in 95 healthy adult participants. The paper confirms the results previously disclosed by the Company with comprehensive clinical and pharmacological characterisation of SDC-1801. Key results include: SDC-1801 was well tolerated across all doses tested, from 5-150 mg, with no deaths and no treatment-related serious adverse events. Pharmacokinetics (PK) analysis demonstrated a half-life of approximately 15-27 hours, supporting once or twice-daily oral dosing. Computational PK modelling demonstrated that SDC-1801 at 70mg twice-daily achieved blood exposure levels comparable to brepocitinib, a clinically validated dual TYK2/JAK1 inhibitor, at 100mg once-daily without the side effects observed with brepocitinib at this exposure level. Pharmacodynamic biomarker analysis provided evidence of sustained target engagement of both TYK2 and JAK1. The PK data from the Phase 1 trial informed the ongoing Phase 2-enabling formulation programme to optimise the capsule, aimed at improving drug release at higher doses and reducing the capsule burden in future clinical trials. Formulation optimisation and the ongoing toxicology programme is being undertaken using the Company's existing cash resources, with a complete Phase 2-enabling regulatory package anticipated by year-end. New Risk • Mar 12
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£3.3m 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£3.3m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings have declined by 24% per year over the past 5 years. Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (UK£20.7m market cap, or US$27.6m). Announcement • Mar 03
Sareum Holdings plc to Report First Half, 2026 Results on Mar 12, 2026 Sareum Holdings plc announced that they will report first half, 2026 results on Mar 12, 2026 Announcement • Feb 18
Sareum Holdings plc Restart of Phase 2-Enabling Toxicology Programme for SDC-1801 Sareum Holdings plc announced that it has restarted the Phase 2-enabling toxicology programme for SDC-1801, a selective TYK2/JAK1 inhibitor being developed as a potential treatment for a range of autoimmune diseases, with an initial focus on psoriasis. The Company has appointed a leading global contract research organisation (CRO), with extensive experience in long-term toxicology studies to conduct the programme following the discontinuation of a previous study, as announced on 10 October 2025. Before restarting, the Company completed preliminary pharmacokinetic (PK) work to evaluate tolerability and exposure levels across different formulations allowing selection of a vehicle with some precedent in long-term studies. The toxicology programme is being conducted using the Company's existing cash resources and toxicology batch of SDC-1801. Completion of this programme, together with ongoing CMC and formulation development activities, will form the Phase 2-enabling regulatory package, positioning the programme for Phase 2 clinical development. The dosing phase of the toxicology studies is expected to complete in mid-2026, with the full Phase 2-enabling package expected to be complete by year-end. As previously reported, the Phase 1 clinical study of SDC-1801 in healthy volunteers met its primary objectives and characterised a pharmacokinetic profile consistent with once-daily dosing. No safety concerns were identified. Announcement • Nov 17
Sareum Holdings plc, Annual General Meeting, Dec 09, 2025 Sareum Holdings plc, Annual General Meeting, Dec 09, 2025. Location: the offices of icr healthcare, 85 gresham street, ec2v 7nq, london United Kingdom Announcement • Oct 24
Sareum Holdings plc Provides Update on Operational Activities and Pipeline Progress Sareum Holdings plc provided a broader update on operational activities and pipeline progress, highlighting the successful completion of the Phase 1 clinical trial for SDC-1801, a TYK2/JAK1 inhibitor being developed for a range of autoimmune diseases with an initial focus on psoriasis, several successful fundraises, providing sufficient cash runway to advance the development of SDC-1801, including longer-term toxicology studies, to prepare the asset for Phase 2 clinical trials. Operating HIGHLIGHTS - Including Post-PERIOD UPDATES SDC-1801 (autoimmune disease) After the period, the 16-week GLP preclinical toxicology study was discontinued following unexpected findings, which were observed more frequently in control-group animals that did not receive SDC-1801. The Company is in discussions with several contract research organizations (CROs) to restart the study as soon as possible, using existing cash resources. Positive topline data from the Phase 1 clinical trial both single ascending dose (SAD) and multiple ascending dose (MAD) reported, demonstrating a favourable safety and tolerability profile, pharmacokinetics supportive of once-daily dosing and dose-responsive pharmacodynamic (PD) biomarker reductions. The full dataset from the Phase 1 clinical trial has been submitted to an academic journal and is going through the journal's review process prior to publication. Phase 2-enabling work, including non-clinical studies and formulation optimisation, is continuing and will support the initiation of Phase 2 clinical trials. None of the potentially dose-limiting side effects which were observed in brepocitinib, Pfizer/Priovant's investigational dual JAK1 and TYK2 inhibitor being developed as an oral treatment for inflammatory autoimmune diseases. The company's intellectual property position has been strengthened with new allowances in key territories, and continued to manage resources prudently, including additional funding during and after the period. The company enter the new financial year with a clear set of milestones: complete the Phase 2-enabling package for SDC-1801 and prepare for the next stage of clinical development, progress partnering for SDC-1802, define the optimal path for SRA737, and advance the CNS discovery programme. PROGRAMME UPDATES SDC- 1801 is a selective TYK2/JAK1 inhibitor being developed for cancer and cancer immunotherapy applications. Preclinical data in disease models also demonstrate the potential for SRA737 to be effective in combinations with Wee1 or PARP targeted therapies in ovarian cancers, and with low-dose gemcitabine and immunotherapy in lung and colon cancers. These funds will support further development of SDC-1802, including completion of the Phase 2-enabling toxicology studies, which are expected to restart as soon as possible, to prepare the asset for phase 2 clinical trials thereby enhancing its potential value. There are adequate technical support for the Phase 2 clinical trials and development and regulatory submissions. SDC-1801 is a TYK2/Jak1 inhibitor. New Risk • Oct 12
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 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 (13% average weekly change). Earnings have declined by 25% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Latest financial reports are more than 6 months old (reported December 2024 fiscal period end). Shareholders have been diluted in the past year (15% increase in shares outstanding). Market cap is less than US$100m (UK£21.4m market cap, or US$28.6m). Announcement • Oct 07
Sareum Holdings plc to Report Fiscal Year 2025 Results on Oct 23, 2025 Sareum Holdings plc announced that they will report fiscal year 2025 results on Oct 23, 2025 New Risk • Sep 02
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 11% 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 (11% average weekly change). Earnings have declined by 25% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (27% increase in shares outstanding). Market cap is less than US$100m (UK£30.2m market cap, or US$40.4m). Announcement • May 29
Sareum Holdings plc Announces Initiation of Toxicology Studies for Lead TYK2/JAK1 Inhibitor, SDC-1801 Sareum Holdings plc announced the initiation of a programme of toxicology studies for its lead TYK2/JAK1 inhibitor, SDC-1801. The studies, designed to support longer-term dosing of SDC-1801, will investigate the general toxicology and potential of SDC-1801 to interact with other drugs. These are key regulatory requirements ahead of the planned Phase 2 clinical development programme, which is expected to focus initially on psoriasis. This marks an important step in advancing Sareum's autoimmune pipeline, following the successful completion of its Phase 1 clinical trial in healthy volunteers, which demonstrated a favourable safety and pharmacokinetic profile. The toxicology studies required to prepare for Phase 2 clinical trials are being conducted at an established Contract Research Organisation and are expected to complete in Fourth Quarter 2025. Sareum continues to make progress, in parallel, with its manufacturing and formulation optimisation activities to support the next stages of development. Announcement • Mar 20
Sareum Holdings plc to Report First Half, 2025 Results on Mar 25, 2025 Sareum Holdings plc announced that they will report first half, 2025 results on Mar 25, 2025 New Risk • Feb 15
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 British stocks, typically moving 7.0% 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 Risks Earnings have declined by 29% per year over the past 5 years. Shareholders have been substantially diluted in the past year (78% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (UK£2.4m net loss next year). Share price has been volatile over the past 3 months (7.0% average weekly change). Market cap is less than US$100m (UK£24.4m market cap, or US$30.7m). Announcement • Dec 31
Sareum Holdings plc Provides an Update on the Status of SRA737 Sareum Holdings plc provided an update on the status of SRA737. SRA737 is a clinical-stage oral, selective Checkpoint kinase 1 inhibitor that targets cancer cell replication and DNA damage repair mechanisms. It was discovered and initially developed by scientists at The Institute of Cancer Research in collaboration with Sareum, with funding from Sareum and Cancer Research UK. In January 2024, Sareum announced that its co-development partner the CRT Pioneer Fund, had entered into a development and commercialisation license for SRA737 with a private biopharma company in the US. Sareum has been notified by CPF that it received notice of termination of the SRA737 licence from the US-based licensee on 26 December 2024. The notice period runs for 90 days and Sareum will meet the team from CPF to discuss what steps, if any, are appropriate to seek an alternative licensee once the asset has returned to CPF on 27th March 2025. Announcement • Nov 28
Sareum Holdings plc, Annual General Meeting, Dec 19, 2024 Sareum Holdings plc, Annual General Meeting, Dec 19, 2024. Location: 88 wood street, ec2v 7qr, london United Kingdom New Risk • Nov 01
New major risk - Revenue and earnings growth Earnings have declined by 29% 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 Earnings have declined by 29% per year over the past 5 years. Shareholders have been substantially diluted in the past year (83% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (UK£2.4m net loss next year). Share price has been volatile over the past 3 months (7.2% average weekly change). Market cap is less than US$100m (UK£31.2m market cap, or US$40.3m). Announcement • Oct 24
Sareum Holdings plc to Report Fiscal Year 2024 Results on Oct 29, 2024 Sareum Holdings plc announced that they will report fiscal year 2024 results at 8:00 AM, GMT Standard Time on Oct 29, 2024 Announcement • Oct 21
Sareum Holdings plc has completed a Follow-on Equity Offering in the amount of £1 million. Sareum Holdings plc has completed a Follow-on Equity Offering in the amount of £1 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 4,444,444
Price\Range: £0.225
Transaction Features: Subsequent Direct Listing New Risk • Oct 14
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 Earnings have declined by 26% per year over the past 5 years. Shareholders have been substantially diluted in the past year (59% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Latest financial reports are more than 6 months old (reported December 2023 fiscal period end). Market cap is less than US$100m (UK£29.1m market cap, or US$38.1m). Announcement • Sep 16
Sareum Holdings plc Receives Notice of Allowance from the China National Intellectual Property Administration Sareum Holdings plc announced that it has received a Notice of Allowance from the China National Intellectual Property Administration. This notice pertains to a patent application protecting certain crystalline forms of SDC-1801, a dual TYK2/JAK1 kinase inhibitor being developed as a potential new therapeutic for a wide range of autoimmune diseases. The Chinese patent, application number 2021800259993, will provide significant protection on several crystalline forms of SDC -1801 and in the methods of their preparation. The Company anticipates the Chinese patent to be granted by the end of 2024, subject to the fulfilment of certain formalities. This is the first patent allowance protecting crystalline forms of S DC-1801 in any territory. Patent applications in other key territories, including the US, Europe, Japan are under review. Announcement • Sep 02
Sareum Holdings plc Receives A Notice of Allowance from the US Patent and Trademark Office for A Patent on SDC-1801 Sareum Holdings plc announced that it has received a Notice of Allowance from the US Patent and Trademark Office (USPTO) for a patent on SDC-1801, a dual TYK2/JAK1 kinase inhibitor being developed as a potential new therapeutic for a range of autoimmune diseases. The US patent, will offer substantial protection on the chemical structure of SDC-1801 and an analogue, their use in treating inflammatory diseases and in certain methods of their chemical synthesis. Sareum has now secured patent coverage in the major territories, following patent approvals by the European Patent Office, China National Intellectual Property Administration and Japan Patent Office for the same protections. The Company expects the US patent to be granted by the end of 2024, subject to the fulfilment of certain formalities with the USPTO. Announcement • Jul 01
Sareum Holdings plc Announces Positive Data from SDC-1801 Phase 1 Clinical Trial Sareum Holdings plc announced positive topline data from its Phase 1a clinical trial of SDC-1801, a dual TYK2/JAK1 kinase inhibitor being developed as a potential new therapeutic for a range of autoimmune diseases. Following the dosing of the final cohort in the Multiple Ascending Dose stage of the trial, and review of the initial data by the Safety Review Committee, the Company reports that: · Blood plasma levels of SDC-1801 significantly in excess of the predicted therapeutic exposure were achieved, with a half-life of between 17 and 20 hours observed, which suggests that once-daily dosing will be possible· No deaths or serious adverse events due to SDC-1801 were reported · Although data remains blinded, there appear to be no significant changes in blood cell counts or increases in serum creatinine levels, which may be dose limiting side-effects of brepocitinib, currently the most advanced TYK2/JAK1 dual inhibitor The Company expects that further data, unblinded from drug/placebo recipients, including details of any mild or moderate adverse events and biomarkers of TYK2 and/or JAK1 inhibition, will be available in Third Quarter 2024. New Risk • Jun 05
New major risk - Revenue and earnings growth Earnings have declined by 26% 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 (28% average weekly change). Earnings have declined by 26% per year over the past 5 years. Shareholders have been substantially diluted in the past year (59% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (UK£45.3m market cap, or US$58.0m). New Risk • Apr 21
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 54% 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 (24% average weekly change). Shareholders have been substantially diluted in the past year (54% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (UK£24.8m market cap, or US$30.7m). Announcement • Apr 04
Sareum Holdings plc has completed a Follow-on Equity Offering in the amount of £1.268973 million. Sareum Holdings plc has completed a Follow-on Equity Offering in the amount of £1.268973 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 9,550,000
Price\Range: £0.0125
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 2,450,000
Price\Range: £0.0125
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 11,189,733
Price\Range: £0.1
Transaction Features: Subsequent Direct Listing Announcement • Mar 29
Sareum Holdings plc has filed a Follow-on Equity Offering in the amount of £0.1875 million. Sareum Holdings plc has filed a Follow-on Equity Offering in the amount of £0.1875 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 9,550,000
Price\Range: £0.0125
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 2,450,000
Price\Range: £0.0125
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 3,000,000
Price\Range: £0.0125
Transaction Features: Subsequent Direct Listing New Risk • Mar 28
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: UK£7.55m (US$9.53m) 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£4.6m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (UK£7.55m market cap, or US$9.53m). Minor Risk Shareholders have been diluted in the past year (3.2% increase in shares outstanding). Breakeven Date Change • Feb 27
Forecast to breakeven in 2026 The 2 analysts covering Sareum Holdings expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of UK£27.2m in 2026. Average annual earnings growth of 90% is required to achieve expected profit on schedule. New Risk • Feb 20
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 14% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-UK£3.3m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (UK£3.4m net loss next year). Shareholders have been diluted in the past year (3.2% increase in shares outstanding). Market cap is less than US$100m (UK£28.1m market cap, or US$35.5m). Announcement • Feb 15
Sareum Holdings plc Announces Completion of the Single Ascending Dose (SAD) Part and the Food Effect Study of its Phase 1a Clinical Trial for the Lead Programme SDC-1801 Sareum Holdings plc announced the completion of the single ascending dose (SAD) part and the food effect study of its Phase 1a clinical trial for the lead programme SDC-1801. SDC-1801 is a dual TYK2/JAK1 kinase inhibitor being developed as a potential new therapeutic for a range of autoimmune diseases with an initial focus on psoriasis, an autoimmune condition affecting the skin. The Phase 1a trial is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of an oral formulation of SDC-1801 in healthy subjects (trial ID ACTRN12623000416695p). This is a randomised, placebo-controlled trial with single and multiple ascending oral dose studies. This trial includes a single ascending dose study (Part 1), a multiple ascending dose study (Part 2) and a food effects study (Part 3). Dosing of the final subjects in the SAD part of the trial has now concluded and the safety review committee for the trial has reviewed available data. The SAD study randomised participants in a 3:1 ratio to a single dose of SDC-1801 or placebo in six dose cohorts. Preliminary blinded safety, tolerability and pharmacokinetics data from the trial indicate a favourable profile and support oral dosing of patients once daily. These preliminary results indicate that SDC-1801 has the potential to achieve therapeutically effective dose levels with no serious adverse events. The food effect study part of the trial has also been completed. The results of this study demonstrated no significant food effect on SDC-1801 blood levels, which will allow full flexibility in dose timing in future clinical studies. The multiple ascending dose study is ongoing and full safety data from the Phase 1a clinical trial are expected to be available during the first half of 2024. If the results are satisfactory and subject to financing, regulatory requirements, and recruitment preparations, the Company plans to initiate a Phase 1b clinical study. The goal is to recruit up to 24 psoriasis patients, with the study expected to be completed by the end of 2024. Announcement • Dec 14
Sareum Holdings plc Provides Update on Operational Activities and Pipeline Progress Sareum Holdings plc announced that at its Annual General Meeting to be held on 14 December 2023, the Company made good progress in 2023 with its lead programme, SDC-1801, with a Phase 1a clinical trial underway in Australia. SDC-1801 (autoimmune disease) SDC-1801, Sareum's TYK2/JAK1 inhibitor, continues to demonstrate promise as a potential new treatment for autoimmune diseases with an initial focus on psoriasis, an autoimmune condition affecting the skin. The Phase 1a clinical trial, evaluating SDC-1801 in healthy subjects, commenced in May 2023 at a specialist clinical unit in Melbourne, Australia. Following approval by the safety review committee, based on preliminary data from the initial cohorts in the single ascending dose part of the study, dosing began in the multiple ascending dose escalation phase of the study in September 2023. The Company has also recently started a food effects study for the compound. This part of the study will inform whether the drug should be taken with food or on an empty stomach, optimising its potential benefits while potentially minimising any possible side effects. Full safety data from the Phase 1a clinical trial are expected to be available during the first half of 2024 and, provided satisfactory results are obtained and subject to financing and regulatory and recruitment preparations, the Company plans to initiate a Phase 1b clinical study, aiming to recruit up to 24 psoriasis patients. This study is expected to be completed before the end of 2024. Also in 2023, the first patent for SDC-1801 was granted by the China National Intellectual Property Administration. This expansion effectively broadens the compound's protective reach beyond its primary focus in immuno-oncology. Sierra Oncology Inc, a subsidiary of GSK plc, has completed the return of the Clinical Study Reports and other associated documents and data related to SRA737 to Sareum's co-development partner, the CRT Pioneer Fund LP ("CPF"). CPF is actively engaged in evaluating potential further development opportunities for SRA737. Further updates will be provided as soon as possible. Sareum drew down an additional PS0.3 million as the Second Deposit under this Facility on 23 November 2023. If fully drawn down, the Facility, together with anticipated tax incentives of PS1.6 million (of which PS0.4 million has already been received), should enable the completion of the Phase 1a/b clinical development of SDC-1801, expected to be a catalyst for driving shareholder value, and for general working capital to fourth quarter 2024. Summary In conclusion, the Board remains optimistic about Sareum's pipeline of kinase inhibitors. Shareholders are reminded that attendance online will not constitute attendance at the AGM and shareholders will not be able to vote on the day. Announcement • Nov 21
Sareum Holdings plc, Annual General Meeting, Dec 14, 2023 Sareum Holdings plc, Annual General Meeting, Dec 14, 2023, at 10:00 Coordinated Universal Time. Location: 85 Gresham Street, London EC2V 7NQ Londoin United Kingdom Announcement • Nov 11
Sareum Holdings plc Initiates Food Effects Study in Phase 1a Trial for SDC-1801 Sareum Holdings plc announced the dosing of the first subjects in the food effects part of its Phase 1a clinical trial of lead programme SDC-1801. Dosing has started at a specialist clinical unit in Melbourne, Australia. The food effects study is a key part of the Phase 1a trial, designed to determine how the presence of food might affect the absorption and pharmacokinetic profile of SDC-1801. This part of the study will inform whether the drug should be taken with food or on an empty stomach, optimising its potential benefits whilst potentially minimising any possible side effects. This study runs in conjunction with the Single Ascending Dose (SAD) and the Multiple Ascending Dose (MAD) parts of the trial, which are concurrently dosing subjects as planned, ensuring a robust assessment of SDC-1801's pharmacological profile. SDC-1801 is a dual TYK2/JAK1 kinase inhibitor being developed as a potential new therapeutic for a range of autoimmune diseases with an initial focus on psoriasis, an autoimmune condition affecting the skin. Full safety data from the Phase 1a trial are expected to be available during the first half of 2024 and, provided satisfactory results are obtained, a Phase 1b clinical study is expected to commence as soon as possible thereafter in psoriasis patients. New Risk • Nov 10
New minor risk - Insider selling There has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: UK£70k This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. 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£3.3m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (UK£3.6m net loss next year). Share price has been volatile over the past 3 months (7.3% average weekly change). Shareholders have been diluted in the past year (3.2% increase in shares outstanding). Significant insider selling over the past 3 months (UK£70k sold). Market cap is less than US$100m (UK£40.4m market cap, or US$49.3m). New Risk • Nov 05
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 3.2% This is considered a minor 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 Less than 1 year of cash runway based on free cash flow trend (-UK£3.3m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (UK£3.6m net loss next year). Share price has been volatile over the past 3 months (7.7% average weekly change). Shareholders have been diluted in the past year (3.2% increase in shares outstanding). Market cap is less than US$100m (UK£43.9m market cap, or US$54.3m). New Risk • Oct 08
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2022. 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 Risk Revenue is less than US$1m. Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Currently unprofitable and not forecast to become profitable over next 2 years (UK£1.8m net loss in 2 years). Share price has been volatile over the past 3 months (8.5% average weekly change). Market cap is less than US$100m (UK£54.5m market cap, or US$66.7m). Announcement • Oct 05
Sareum Holdings plc to Report Fiscal Year 2023 Results on Oct 09, 2023 Sareum Holdings plc announced that they will report fiscal year 2023 results on Oct 09, 2023 Announcement • Sep 05
Sareum Holdings plc Starts Dosing First Subjects in the Multiple Ascending Dose Part of Phase 1a Clinical Trial for SDC-1801 Sareum Holdings plc announced the successful dosing of the first subjects in the multiple ascending dose part of its Phase 1a clinical trial for lead programme SDC-1801. Dosing has started at a specialist clinical unit in Melbourne, Australia, and subjects will receive SDC-1801 orally once daily for 10 days. This follows approval by the safety review committee granted upon review of preliminary data generated from the initial three cohorts in the single ascending dose part of the study. The committee deemed these data as satisfactory for the multiple ascending dose part of the study to commence, as well as for continued dose escalation in the single ascending dose part the study. SDC-1801 is a dual TYK2/JAK1 kinase inhibitor being developed as a potential new therapeutic for a range of autoimmune diseases with an initial focus on psoriasis, an autoimmune condition affecting the skin. The Phase 1a trial is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of an oral formulation of SDC-1801 in healthy subjects (trial ID ACTRN12623000416695p). This is a randomised, placebo-controlled trial with single and multiple ascending oral dose studies. This trial includes a single ascending dose study (Part 1), a multiple ascending dose study (Part 2) and a food effects study (Part 3). The safety and pharmacokinetics data from the initial cohorts in Part 1 of the trial indicate a favourable profile and fully support oral dosing of patients once daily. Full safety data from the Phase 1a trial are expected to be available during the first half of 2024 and, provided satisfactory results are obtained, a Phase 1b clinical study is expected to commence as soon as possible thereafter in psoriasis patients. Announcement • Aug 17
Sareum Holdings plc Provides Earnings Guidance for the Year to 30 June 2023 Sareum Holdings plc provides earnings guidance for the year to 30 June 2023. The loss for the year to 30 June 2023 is expected to be around £3.3 million after tax, (2022: £2.2 million), which is in-line with market expectations and reflects the increased costs associated with setting up for and commencing clinical studies. New Risk • Jul 21
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 11% 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 (11% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (UK£1.3m net loss in 2 years). Market cap is less than US$100m (UK£74.9m market cap, or US$96.2m). New Risk • Jul 12
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: UK£76.6m (US$99.5m) 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 Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (UK£1.3m net loss in 2 years). Share price has been volatile over the past 3 months (9.8% average weekly change). Market cap is less than US$100m (UK£76.6m market cap, or US$99.5m). Announcement • May 19
Sareum Holdings plc Announces the Commencement of A Phase 1a Clinical Trial for SDC-1801 Sareum Holdings plc announced the initiation of a Phase 1a clinical trial for its lead product SDC-1801. The trial has started with patient recruitment in progress at specialist clinical units located in Victoria, Australia. SDC-1801 is a TYK2/JAK1 inhibitor being developed as a potential new therapeutic for a range of autoimmune diseases with an initial focus on psoriasis, an autoimmune condition affecting the skin. This follows the recent approval of the Company's application under the Clinical Trial Notification (CTN) scheme by the Human Research Ethics Committee (HREC). Australia's medicines regulator, the Therapeutic Goods Administration (TGA), has also acknowledged the application, allowing for the Phase 1a trial to proceed. The initial Phase 1a trial is designed to investigate the safety and pharmacokinetics of an oral formulation of SDC-1801 in healthy subjects (trial ID ACTRN12623000416695p). provided satisfactory safety data are obtained from this initial study, a Phase 1b clinical study is expected to commence in psoriasis patients in 2024. Board Change • Nov 16
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 1 highly experienced director. Independent Non-Executive Director Mike Owen was the last director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Board Change • Apr 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 1 highly experienced director. Independent Non-Executive Director Mike Owen was the last director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Board Change • Jan 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 1 highly experienced director. Independent Non-Executive Director Mike Owen was the last director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Board Change • Dec 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 1 highly experienced director. Independent Non-Executive Director Mike Owen was the last director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Recent Insider Transactions Derivative • Nov 04
Founder exercised options and sold UK£123k worth of stock On the 3rd of November, John Reader exercised 3m options at a strike price of around UK£0.012 and sold these shares for an average price of UK£0.06 per share. This trade did not impact their existing holding. Since March 2021, John has owned 51.63m shares directly. Company insiders have collectively sold UK£246k more than they bought, via options and on-market transactions in the last 12 months. Announcement • Jul 22
Sareum Holdings plc Provides Financial Guidance for Fiscal 2021 Sareum Holdings plc announced that based on the dynamic business performance in the first half, strong order intake, and on expanded production capacities, management raised its full-year growth forecast again at the beginning of July for fiscal 2021. Accordingly, the Sartorius Group projects consolidated sales growth of around 45%(previously around 35%). For the Bioprocess Solutions Division, sales are anticipated to increase by about 50% (previously about 40%). Sales growth for the Lab Products & Services Division is expected to be around 30% (previously around 20%). Announcement • Feb 16
Sareum Holdings plc Launched of Its AGILE Clinical Development Platform to Fund Phase 1 Trials and Fast-Track the Development of Potentially Ground-Breaking COVID-19 Treatments Sareum Holdings plc launched of its AGILE clinical development platform to fund Phase 1 trials and fast-track the development of potentially ground-breaking Covid-19 treatments. The Company views this new platform as a welcome source of funding to support the early clinical development of promising new candidates to address the breadth of symptoms that affect patients with Covid-19. As previously announced, Sareum is currently investigating SDC-1801, its selective, small molecule TYK2/JAK1 kinase inhibitor, in a preclinical Covid-19 research programme. The programme, which commenced in December 2020 with grant funding from the UK government, is expected to take approximately six months to complete and aims to investigate the effects of SDC-1801 on cytokine signalling after human cells are infected with SARS-CoV-2, to confirm whether an over-active inflammatory response (known as a 'cytokine storm') via the Interferon Type 1 pathway can be blocked in this disease. The Company is also investigating whether treatment with SDC-1801 in disease models can re-establish protection against bacterial pneumonia following SARS-CoV-2 infection. The company has previously stated it would require additional funding to advance SDC-1801 into clinical trials depending both on positive results from its ongoing Covid-19 research programme and on the successful outcome of the Company's broader preclinical development programme with SDC-1801. The Company believes that, should the current preclinical work programme be successful and indicate that SDC-1801 is a potential treatment for severe-phase Covid-19, the Company may be eligible for an AGILE grant. Announcement • Jan 09
Sareum Holdings plc Provides Update on FLT3+Aurora Kinase Inhibitor Programme Sareum Holdings plc reported that the licensing partner for its FLT3+Aurora kinase programme has decided not to exercise its option to continue the development of the programme. Sareum received formal confirmation of the Licensee's decision. Worldwide rights to the FLT3 programme, as well as data relating to progress made by the Licensee, will therefore revert to Sareum. Announcement • Dec 16
Sareum Holdings plc Announces TYK2 as Key Causative Genetic Mechanism and Potential Target for Therapy Sareum Holdings plc noted that a multi-centre analysis of DNA samples from patients with severe forms of Covid-19, including symptoms caused by the over-active inflammatory response (cytokine storm), has identified TYK2 as a key causative genetic mechanism and a potential target for therapy. This observation, which was published online as an Accelerated Article Preview by Nature on 11 December 2020 (Pairo-Castineira, E. et al.) is consistent with the scientific rationale supporting Sareum's recent successful UK Research & Innovation (UKRI) grant application for its proprietary TYK2/JAK1 inhibitor, SDC-1801. The funding from this grant (announced by the Company on 3 December 2020) will be used to investigate the therapeutic potential of SDC-1801 in severe phase Covid-19, in a six-month research project, with results expected around mid-2021. This research will treat cells infected with the SARS-CoV-2 virus with SDC-1801 to evaluate its potential to block the immune pathway that leads to the cytokine storm in this life-threatening disease. Sareum also intends to investigate if treatment with SDC-1801 in disease models can re-establish protection against bacterial pneumonia following SARS-CoV-2 infection. Announcement • Nov 19
Sareum Holdings plc, Annual General Meeting, Dec 15, 2020 Sareum Holdings plc, Annual General Meeting, Dec 15, 2020, at 10:00 Coordinated Universal Time. Location: 2a Langford Arch Cambridge United Kingdom Announcement • Oct 08
Sareum Holdings plc Announces That US Patent Allowance for Sareum's SDC-1802 TYK2/JAK1 Inhibitor Sareum Holdings plc announced that the United States Patent and Trademark Office has issued a Notice of Allowance for a patent in respect of an invention associated with Sareum's proprietary SDC-1802 TYK2/JAK1 Kinase Inhibitor Programme. This programme is in preclinical development and targets cancer and cancer immunotherapy. The patent (US Patent Application no. 16/351,620) will protect the SDC-1802 molecule and pharmaceutical preparations thereof. Subject to certain formalities being completed, the Company expects that the patent will be granted within three months. Following the grant of this patent, Sareum will have approved patent protection in the US for its SDC-1802 Programme and the grant will complete the patent protection for this programme across all major territories. This follows similar patent protection being granted to the Company in Europe, announced on 10 November 2014, and in Japan and China, announced on 19 December 2017. 