Aankondiging • Apr 28
MEDLEAP Pharma Confirms Enrollment in Phase II Clinical Trial for Accrufer in Japan Shield Therapeutics plc announced that its partner, MEDLEAP Pharma, a subsidiary of Vital KSK Holdings Inc. has confirmed its first patient enrollment for the Phase II clinical trial for ACCRUFeR (ferric maltol), a new drug candidate for Pulmonary Arterial Hypertension (PAH), for patients in Japan. This clinical trial is an exploratory study intended to support a planned Phase III trial. It follows the Pharmaceuticals and Medical Devices Agency's (PMDA) confirmation of the development plan for the drug as a PAH treatment in Japan, based on the drug's prior clinical results from trials in Europe, the UK, and the USA. Trial Details: Trial Name: An Exploratory Phase II Study to Evaluate the Efficacy and Safety of Ferric Maltol in Patients with Pulmonary Arterial Hypertension. Target Disease: Pulmonary Arterial Hypertension. Trial Location: Japan. ACCRUFeR/FeRACCRU (ferric maltol) is a novel, stable, non-salt-based oral therapy for patients suffering from iron deficiency, with or without anemia. The drug has a novel mechanism of absorption compared to other oral iron therapies and has been shown to be an efficacious and well-tolerated therapy in a range of clinical trials. More information about ACCRUFeR/FeRACCRU, including the product label, can be found at: www.accrufer.com and www.feraccru.com. PAH (Pulmonary Arterial Hypertension) market in 2024 is estimated to be worth over $230M in Japan. Iron supplementation is strongly recommended for PAH patients with iron deficiency anemia according to both European and Japanese guidance (ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension 2022 and Japan Pulmonary Hypertension and Pulmonary Circulation Society Guidance 2024) [Recommendation Class I]. (1) Humbert M, et al. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J. 2023; 61(1):2200879. (2) Japanese Pulmonary Hypertension and Pulmonary Circulation Society. Pulmonary Hypertension Treatment Guidance 2024. Aankondiging • Apr 11
Shield Therapeutics plc, Annual General Meeting, Jun 18, 2026 Shield Therapeutics plc, Annual General Meeting, Jun 18, 2026. Location: the offices of shield therapeutics plc, northern design centre, baltic business quarter, gateshead quays, england, ne8 3df, United Kingdom Aankondiging • Apr 02
Shield Therapeutics plc Announces European Medicines Agency Approves Extension of Indication for FeRACCRU to Include Adolescents Shield Therapeutics plc announced that the European Medicines Agency (EMA) have published the CHMP meeting highlights in which they confirm their adoption of a positive opinion for the extension of the indication for FeRACCRU (ferric maltol) to include adolescents. FeRACCRU will now be indicated for the treatment of iron deficiency in adult and pediatric patients 12 years of age and older. EMA have also confirmed that all measures in the agreed Pediatric Investigation Plan (PIP) for FeRACCRU have been fulfilled. The indication expansion was supported by positive results from the Phase 3 pediatric clinical trial (FORTIS/ST10-01-305) that confirmed the efficacy, safety, and tolerability of the new oral liquid pediatric formulation in children aged 1 month and above with iron deficiency, presenting as iron deficiency anemia (IDA). Shield's licensing partner, Norgine B.V. holds the marketing authorisation and is responsible for commercialising FeRACCRU in the European Union. Shield will receive a milestone payment of EUR 500,000 from Norgine related to this EMA approval for the term of the agreement. Clinically low iron levels (aka iron deficiency, ID) can cause serious health problems for adults of all ages, across multiple therapeutic areas. Together, ID and ID with anemia (IDA) affect about 20 million people in the US and represent a $2.3B market opportunity. As the first and only FDA approved oral iron to treat ID/IDA, ACCRUFeR has the potential to meet an important unmet medical need for both physicians and patients and is now the #1 branded prescription oral iron the market today (*data source - IQVIA Xponent PlanTrak). ACCRUFeR/FeRACCRU (ferric maltol) is a novel, stable, non-salt-based oral therapy for adults with ID/IDA. The drug has a novel mechanism of absorption compared to other oral iron therapies and has been shown to be an efficacious and well-tolerated therapy in a range of clinical trials. More information about ACCRUFeR/FeRACCRU, including the product label, can be found at: www.accrufer.com and www.feraccru.com. The open label randomized Phase 3 study included children aged 1 month to 17 years with mild to moderate IDA, who also had serum ferritin levels below 30 µg/L or ferritin levels below 50 µg/L and transferrin saturation below 20%. Children aged 2 to 17 years were randomized 1:1 to receive either ferric maltol (N=31) or ferrous sulphate (N = 30). Children 1 month to under 2 years (N=4) were all assigned to receive ferric maltol treatment. The full data sets have been submitted for peer-review and subsequent presentation/publication. The trial is the final study in the comprehensive pediatric development program that Shield committed to implement with both the European EMA and the US FDA. Aankondiging • Mar 05
Shield Therapeutics Plc Announces Chinese NMPA Accepts MAA Submission For ACCRUFeR Shield Therapeutics plc announced the filing, and acceptance by the Chinese National Medical Products Administration ('NMPA'), of a Marketing Authorisation Application ('MAA') for ACCRUFeR for the treatment of adults with Iron Deficiency by its licensing partner, Beijing Aosaikang Pharmaceutical Co. Ltd. ('ASK Pharm'). The MAA is supported by the data Package used to obtain USA FDA approval for ACCRUFeR for the treatment of iron deficiency in adults, supplemented by Phase 3 data confirming the effectiveness of ACCRUFeR in an adult Chinese population. This follows the successful completion and outcome of a Phase 3 efficacy and safety clinical study in Chinese adults with iron deficiency anemia ('IDA') and inflammatory bowel disease who are intolerant to oral ferrous products. The study demonstrated clinically and statistically relevant efficacy and good tolerance in Chinese adults. ACCRUFeR/FeRACCRU (ferric maltol) is a novel, stable, non-salt-based oral therapy for adults with ID/IDA. The drug has a novel mechanism of absorption compared to other oral iron therapies and has been shown to be an efficacious and well-tolerated therapy in a range of clinical trials. China's iron deficiency anemia (IDA) therapy market is growing rapidly, projected to double from around $280 million in 2022 to over $600 million by 2030. This growth is driven by increased healthcare access, government initiatives, and rising awareness. High-risk groups include women of reproductive age, pregnant women, and children-particularly in central-south and western regions. ACCRUFeR/FeRACCRU has patent coverage until the mid-2030s. ACCRUFeR/FeRACCRU are registered trademarks of Shield Therapeutics. The double-blind placebo-controlled randomized Phase 3 study included adults with mild to moderate iron-deficiency anemia (IDA) and Inflammatory Bowel Disease (IBD) who are intolerant to oral ferrous product, and who also had serum ferritin levels below 100 µg/L and transferrin saturation below 20%. Subjects were randomized 1:1 to receive either ferric maltol (N=60) or placebo (N = 61) bid for 12 weeks. Aankondiging • Feb 18
Shield Therapeutics plc Announces U.S. Food and Drug Administration Approval of ACCRUFeR Shield Therapeutics plc announced that ACCRUFeR (ferric maltol) is the first and only prescription oral iron treatment approved by the U.S. Food and Drug Administration for the treatment of iron deficiency in children age 10 and older. ACCRUFeR has been FDA-approved and prescribed for adults with iron deficiency since 2019. Iron deficiency affects about 2.4 million children in the United States, with adolescents at a particularly high risk. Up to 40% of females age 12-21 may be affected due to periodation and increased iron needs during period. Other common risk factors include not eating enough iron-rich foods, high-intensity athletic training, obesity, and growth spurts. Early treatment of iron deficiency in children is critical. Un unnoticed or untreated iron deficiency can lead to developmental delays, difficulty with learning and concentration, decreased academic performance, behavioral issues, and a weakened immune system. Common signs of low iron in children include unusual fatigue, paleness, irritability, or difficulty keeping up in school or activities. If parents have concerns surrounding iron deficiency they should speak with their child's doctor who may recommend performing blood tests to diagnose iron deficiency or iron deficiency anemia. Many families have experienced challenges with traditional iron supplements, which can cause stomach upset, nausea, or constipation - side effects that make it difficult for children to stick with treatment. ACCRUFeR®? was designed with tolerability in mind. For children ages 10 and up, ACCRUFeRACCRU®? is a new option that can help restore iron levels while minimizing the risk of GI side effects. Aankondiging • Feb 11
Shield Therapeutics plc Announces FDA Grants Additional 3 Years Exclusivity for ACCRUFeR Shield Therapeutics plc announced that the US Food and Drug Administration (FDA) has granted to Shield an additional 3 years of Data Exclusivity for ACCRUFeR (ferric maltol). This is due to the new clinical investigation conducted by Shield that was essential to the approval of the extension of the indication to include pediatric patients 10 years of age and older. This exclusivity remains in place until 19 December 2028 in addition to the ACCRUFeR)/FeRACCRU patent coverage valid until the mid-2030s. The indication expansion was supported by positive results from the Phase 3 pediatric clinical trial (FORTIS/ST10-01-305) that confirmed the efficacy, safety, and tolerability of the new oral liquid pediatric formulation in children aged 1 month and above with iron deficiency, presenting as iron deficiency anemia (IDA). Aankondiging • Nov 11
Shield Therapeutics plc Announces the Presentation of Accrufer Pediatric Pharmacokinetic (Pk) Study Shield Therapeutics plc announced the presentation (Abstract/Video and in person Poster) of a PK study (conducted as a sub-study of the positive FORTIS efficacy, tolerability and palatability pediatric ferric maltol clinical trial) at the American Society of Hematology (ASH) National Conference on 06 December 2025 in Orlando, Florida. Key Results: The PK profile in children and adolescents demonstrated ferric maltol's suitability for iron replacement in all age groups; Iron was well-absorbed at the age-appropriate doses used in the Phase 3 study; Maltol was rapidly metabolised and excreted in the urine with no accumulation in any age group; First data that confirms maltol metabolism and rapid excretion in the urine in infants 1 month to less than 2 years. The FORTIS study, including the PK data, is pivotal in supporting the Clinical Supplement assigned Priority Review by the US FDA to extend the indication for ACCRUFeR®? to include adolescents aged 10 years and above. Aankondiging • Nov 09
Shield Therapeutics plc Receives Marketing Authorisation by Korean Ministry of Food and Drug Safety Shield Therapeutics plc announced that the Korean Ministry of Food and Drug Safety (MFDS) has granted regulatory approval for ACCRUFeR (Ferric Maltol) in the Republic of Korea (South Korea) for the treatment of iron deficiency in adult subjects. This approval is an important milestone and follows the successful completion of a pharmacokinetic (PK) study which confirmed that the absorption of iron from ACCRUFeR was comparable between patients in South Korea and the patient population enrolled in the key clinical studies supporting ACCRU FeR®? effectiveness and safety and the subsequent submission of a New Drug Application (NDA) by Korea Pharma ("KP") in 2024. This approval marks a significant step forward in expanding access to ACCRUFeR for patients in South Korea suffering from iron deficiency. Shield is eligible to receive payments upon the first sale, as well as performance-based sales milestones and royalties on net sales of ACCRUFeR of South Korea. Aankondiging • Sep 15
Shield Therapeutics plc has completed a Follow-on Equity Offering in the amount of £1.5 million. Shield Therapeutics plc has completed a Follow-on Equity Offering in the amount of £1.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 20,000,000
Price\Range: £0.075
Transaction Features: Subsequent Direct Listing Aankondiging • Sep 04
Shield Therapeutics plc Announces ACCRUFeR® Assigned Priority Review in US by FDA Shield Therapeutics plc announced that the US Food and Drug Administration (FDA) has accepted ACCRUFeR®/FeRACCRU® (ferric maltol) as a Clinical Supplement and assigned Priority Review to extend the indication for ACCRUFeR®/FeRACCRU® to include adolescents aged 10 years and above. Following the positive results from the Phase 3 pediatric clinical trial (FORTIS/ST10-01-305) that confirmed the efficacy, safety, and tolerability of the new oral liquid pediatric formulation in children with (IDA), Shield submitted a clinical supplement application to the FDA in June 2025 for the approval of ACCRUFeR®/FeRACCRU® in the pediatric population. FDA has granted Priority Review for the supplement as it supports the extension of the label to a pediatric population based on a final agreed pediatric study report. Pending successful review, approval is anticipated in 2026. Shield plans to file for a further extension of the indication to include children 1 month and above in conjunction with the submission of an NDA for a new pediatric formulation (ferric maltol suspension) which was used in the successful FORTIS Phase 3 study in this population. If approved, this formulation may also offer an alternative approach for adults who can't swallow current capsule formulation. Shield's licensing partner in the EU, Norgine B.V., also filed a regulatory submission to the EMA in Second Quarter 2025 for the approval of FeRACCRU® (ferric maltol) in the adolescent population. Pending successful review, approval is also anticipated in 2026. Aankondiging • Aug 28
Shield Therapeutics plc Announces Positive Efficacy and Safety Results in the Orion-Hf Study Shield Therapeutics plc announced positive efficacy and safety results in the ORION-HF study showing improvements in haemoglobin and other iron markers, exercise capacity, and quality of life (QoL) in patients with heart failure (HF) and iron deficiency anemia (IDA), after 16 weeks of treatment with FeRACCRU®? (ferric maltol). These results were published in the European Journal of Heart Failure on 21 July 2025. The ORION-HF study was a multicenter, European, open-label, prospective clinical study, to investigate the impact of orally formulated ferric maltol (30 mg bid) in 50 patients with symptomatic HF and IDA. Positive and clinically meaningful efficacy and safety results were achieved in the study: Significant increase in haemoglobin (Hb) concentration (Primary endpoint): Oral ferric maltol treatment resulted in significantly increased haemoglobin (from 11.4 [10.9-11.9] to 12.8 [11.8-13.8] g/dl) from baseline to week 16 (p<0.001). Statistically significant differences from baseline to week 16 in 6-minute walk test (6MW) (p<0.001) and Quality of Life scores (p=0.004) o Oral ferric maltol treatment resulting in significant increase in distance walk in 6MW test (from 298 [220-405] to 335 [255-430] meters). Oral ferric maltol treatment result in a significant increase in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score (from 65 [44-82] to 76 [55-86] score points). Statistically significant differences from base to week 16 in Other Iron Markers (ferritin, iron, transferrin saturation) (p<0.1). Ferric maltol was well-tolerated with no serious related adverse events reported o Adverse event profiles were consistent with previous Phase 3 studies. o AEs (N=19) were mainly GI related. These positive results published in the European Journal of heart failure - Kempf - European Journal of Heart Failure - Wiley Online Library,) are consistent with results reported from an earlier study in patients with pulmonary hypertension (PH) and anemia published in the European Respiratory Society (Oral iron supplementation with ferric maltol in patients with pulmonary hypertension | European Respiratory Society). Shield's licensing partner in Japan (VITAL-NET Inc. (VITAL-NET)) has recently had an IND approved to further investigate the impact of ferric maltol treatment in Japanese patients with PH and anemia in Japan. Reported Earnings • Aug 24
First half 2025 earnings released: US$0.009 loss per share (vs US$0.02 loss in 1H 2024) First half 2025 results: US$0.009 loss per share (improved from US$0.02 loss in 1H 2024). Revenue: US$21.4m (up 77% from 1H 2024). Net loss: US$9.54m (loss narrowed 38% from 1H 2024). Revenue is forecast to grow 30% p.a. on average during the next 3 years, compared to a 2.8% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 66% per year but the company’s share price has fallen by 8% per year, which means it is significantly lagging earnings. Breakeven Date Change • Aug 21 The 3 analysts covering Shield Therapeutics previously expected the company to break even in 2027. New consensus forecast suggests losses will reduce by 66% per year to 2026. The company is expected to make a profit of US$32.1m in 2027. Average annual earnings growth of 131% is required to achieve expected profit on schedule.
Aankondiging • Mar 12
Shield Therapeutics plc Launches ACCRUFeR in Partnership with Kye Pharmaceuticals, Inc Shield Therapeutics plc announced that it has launched ACCRUFeR® in Canada in partnership with its Canadian partner, Kye Pharmaceuticals Inc. ("Kye"). This follows approval in August 2024 from Health Canada for ACCRUFeR(r) (ferric maltol) as a prescription drug for the treatment of adults with iron deficiency anemia ("IDA"). ACCRUFeR® is currently the sole prescription-only oral treatment option indicated for IDA in Canada and is available by prescription through pharmacies across Canada. Shield will be responsible for all manufacturing and supply to the Canadian market. In accordance with the collaborative agreement Shield is eligible to receive further milestone payments upon the achievement of specified calendar net sales targets and will also receive double-digit royalties on net sales of ACCRUFeR®, for the term of agreement. Aankondiging • Dec 08
Shield Therapeutics plc has filed a Follow-on Equity Offering in the amount of £8.692308 million. Shield Therapeutics plc has filed a Follow-on Equity Offering in the amount of £8.692308 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 256,410,256
Price\Range: £0.03
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 33,333,333
Price\Range: £0.03
Transaction Features: Subsequent Direct Listing Breakeven Date Change • Oct 30
No longer forecast to breakeven The 3 analysts covering Shield Therapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$29.3m in 2025. New consensus forecast suggests the company will make a loss of US$3.77m in 2025. New Risk • Sep 06
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next year. Trailing 12-month net loss: US$36m Forecast net loss in 1 year: US$4.2m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (26% average weekly change). Minor Risks Less than 1 year of cash runway based on current free cash flow (-US$23m). Currently unprofitable and not forecast to become profitable next year (US$4.2m net loss next year). Shareholders have been diluted in the past year (9.7% increase in shares outstanding). Market cap is less than US$100m (€45.0m market cap, or US$49.9m). Aankondiging • Aug 27
Shield Therapeutics plc Announces Health Canada Approves ACCRUFeR as Prescription Drug for the Treatment of Adults with Iron Deficiency Anemia Shield Therapeutics plc announced that Health Canada has approved ACCRUFeR (ferric maltol) as a prescription drug for the treatment of adults with iron deficiency anemia. This development allows Shield's partner, Kye pharmaceuticals Inc., to launch ACCRUFeR in Canada. Shield will be responsible for all manufacturing and supply to the Canadian market. In accordance with the collaborative agreement, Shield is now due to receive a £250,000 milestone payment. For the remaining term of the agreement, Shield will receive additional revenue-based milestone payments along with double-digit royalties on net sales of ACCRUFeR. Aankondiging • Aug 14
Shield Therapeutics plc to Report First Half, 2024 Results on Sep 04, 2024 Shield Therapeutics plc announced that they will report first half, 2024 results on Sep 04, 2024 Buy Or Sell Opportunity • Aug 02
Now 29% overvalued after recent price rise Over the last 90 days, the stock has risen 175% to €0.038. The fair value is estimated to be €0.03, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has grown by 14% over the last 3 years. Earnings per share has declined by 3.8%. Revenue is forecast to grow by 155% in a year. Earnings are forecast to grow by 49% in the next year. Aankondiging • Jul 24
Shield Therapeutics plc Announces CEO Changes Shield Therapeutics plc announced that Greg Madison, Chief Executive Officer, will be stepping down from the Board by mutual consent to pursue other opportunities and will be leaving the Company with immediate effect. Anders Lundstrom, one of the Company's independent non-executive Directors was appointed interim Chief Executive Officer. Anders, who is based in Boston, Massachusetts, has strong international and US senior commercial and general management experience gained from a range of pharmaceutical and biotech companies including AstraZeneca, Biogen and Orexo (where he was president and CEO). Aankondiging • Jul 03
Rudolf Widmann Joins Board of Shield Therapeutics plc as Non-Executive Director Shield Therapeutics plc announced that AOP's founder, Dr. Rudolf Widmann, will join the Shield Board as a Non-Executive Director, effective immediately. Dr. Rudolf Widmann is an experienced pharmaceutical scientist, seasoned executive and entrepreneur who has devoted his career to advancing the care of patients with rare diseases. He foundedAOP Health (AOP Orphan Pharmaceuticals GmbH)in 1996, starting as Chief Executive Officer and Chief Therapeutics Development Officer and later elected to serve as a governing Board Member of the AOP Health Group. Dr. Widmann holds a degree in pharmacy studies and a PhD in pharmacology from the University of Innsbruck. Shield also discloses the following information in accordance with Schedule 2(g) of the AIM Rules for Companies. Full name: Dr. Rudolf Stefan Widmann. Age: 67 years. Current directorships/partnerships: AOP Health International Management AG and Wirucon GmbH. Previous directorships/partnerships held in the past 5 years: AOP Orphan Limited, Irorph GmbH, Orphanidis Pharma Research GmbH, and OrphaCare GmbH. Dr. Widmann does not hold any ordinary shares in Shield. Board Change • Jul 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. 9 experienced directors. 1 highly experienced director. CEO & Executive Director Greg Madison was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Aankondiging • May 15
Shield Therapeutics plc, Annual General Meeting, Jun 20, 2024 Shield Therapeutics plc, Annual General Meeting, Jun 20, 2024. Location: the offices of shield therapeutics plc, northern design centre, baltic business quarter, ne8 3df, gateshead quays United Kingdom Reported Earnings • May 13
Full year 2023 earnings released: US$0.05 loss per share (vs US$0.21 loss in FY 2022) Full year 2023 results: US$0.05 loss per share (improved from US$0.21 loss in FY 2022). Revenue: US$13.1m (up 142% from FY 2022). Net loss: US$33.3m (loss narrowed 32% from FY 2022). Revenue is forecast to grow 32% p.a. on average during the next 3 years, compared to a 3.3% growth forecast for the Pharmaceuticals industry in Germany. Aankondiging • May 01
Shield Therapeutics plc to Report Fiscal Year 2023 Final Results on May 10, 2024 Shield Therapeutics plc announced that they will report fiscal year 2023 final results on May 10, 2024 New Risk • Apr 24
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 Risk Share price has been highly volatile over the past 3 months (37% average weekly change). Minor Risks Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Shareholders have been diluted in the past year (34% increase in shares outstanding). Market cap is less than US$100m (€13.0m market cap, or US$13.9m). Aankondiging • Apr 16
Shield Therapeutics plc to Report Fiscal Year 2023 Final Results on Apr 30, 2024 Shield Therapeutics plc announced that they will report fiscal year 2023 final results on Apr 30, 2024 Aankondiging • Jan 10
Shield Therapeutics Appoints Santosh Shanbhag as New CFO, Effective January 16, 2024 Shield Therapeutics plc appointed Santosh Shanbhag as Chief Financial Officer, effective January 16, 2024. The company's previous finance chief Hans-Peter Rudolf had stepped down from the post in October to pursue other opportunities. Before joining Shield, Shanbhag, with more than 20 years of experience in leading finance roles, was workingwith Akili Inc. as CFO. Recent Insider Transactions • Nov 30
Independent Non Executive Chairman recently bought €140k worth of stock On the 21st of November, Hans-Peter Hasler bought around 2m shares on-market at roughly €0.07 per share. This transaction amounted to 57% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Hans-Peter's only on-market trade for the last 12 months. New Risk • Nov 17
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: -US$30m 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 (-US$30m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Shareholders have been substantially diluted in the past year (204% increase in shares outstanding). Minor Risk Market cap is less than US$100m (€54.1m market cap, or US$58.8m). Aankondiging • Oct 12
Shield Therapeutics plc Announces Hans-Peter Rudolf Is Standing Down from His Role as Chief Financial Officer on 20 October 2023 Shield Therapeutics plc announces that Hans-Peter Rudolf is standing down from his role as Chief Financial Officer ("CFO") of the Group to pursue other opportunities. Hans-Peter will step down from this role as of 20 October 2023, and is available for consulting through to the end of the month. His resignation is not the result of any dispute or disagreement with Shield on any matters relating to Shield's financial statements, internal controls, operations, policies or practices. Shield also announces that Paul Spoors, Group Company Controller since 2019, will assume additional responsibility and report directly to the Shield's Chief Executive Officer, Greg Madison, on an interim basis. The Company has hired an executive search firm to identify a new Chief Financial Officer and a further announcement relating to this appointment will be made in due course. Aankondiging • Oct 05
Shield Therapeutics plc has completed a Follow-on Equity Offering in the amount of £5.109782 million. Shield Therapeutics plc has completed a Follow-on Equity Offering in the amount of £5.109782 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 41,380,508
Price\Range: £0.08
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 21,012,552
Price\Range: £0.08
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,479,211
Price\Range: £0.08
Transaction Features: Regulation S; Subsequent Direct Listing Reported Earnings • Sep 29
First half 2023 earnings released: US$0.025 loss per share (vs US$0.069 loss in 1H 2022) First half 2023 results: US$0.025 loss per share (improved from US$0.069 loss in 1H 2022). Revenue: US$4.33m (up 69% from 1H 2022). Net loss: US$12.6m (loss narrowed 16% from 1H 2022). Revenue is forecast to grow 62% p.a. on average during the next 3 years, compared to a 3.5% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 46% per year but the company’s share price has fallen by 58% per year, which means it is performing significantly worse than earnings. Aankondiging • Sep 29
Shield Therapeutics plc has completed a Follow-on Equity Offering in the amount of £4.991445 million. Shield Therapeutics plc has completed a Follow-on Equity Offering in the amount of £4.991445 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 41,380,508
Price\Range: £0.08
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 21,012,552
Price\Range: £0.08
Transaction Features: Regulation S; Subsequent Direct Listing New Risk • Sep 28
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£19m 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£19m free cash flow). Share price has been highly volatile over the past 3 months (27% average weekly change). Shareholders have been substantially diluted in the past year (177% increase in shares outstanding). Minor Risk Market cap is less than US$100m (€63.4m market cap, or US$67.1m). Aankondiging • Sep 08
Shield Therapeutics plc to Report First Half, 2023 Results on Sep 28, 2023 Shield Therapeutics plc announced that they will report first half, 2023 results on Sep 28, 2023 Aankondiging • May 20
Shield Therapeutics plc, Annual General Meeting, Jun 28, 2023 Shield Therapeutics plc, Annual General Meeting, Jun 28, 2023, at 13:00 Coordinated Universal Time. Location: Northern Design Centre, Baltic Business Quarter, Gateshead Quays, England NE8 3DF England United Kingdom Breakeven Date Change • May 05
Forecast breakeven date pushed back to 2025 The 4 analysts covering Shield Therapeutics previously expected the company to break even in 2024. New consensus forecast suggests losses will reduce by 84% per year to 2024. The company is expected to make a profit of UK£28.9m in 2025. Average annual earnings growth of 99% is required to achieve expected profit on schedule. Breakeven Date Change • Apr 28
Forecast breakeven date pushed back to 2025 The 4 analysts covering Shield Therapeutics previously expected the company to break even in 2024. New consensus forecast suggests losses will reduce by 86% per year to 2024. The company is expected to make a profit of UK£30.9m in 2025. Average annual earnings growth of 96% is required to achieve expected profit on schedule. Breakeven Date Change • Apr 06
Forecast breakeven date pushed back to 2025 The 4 analysts covering Shield Therapeutics previously expected the company to break even in 2024. New consensus forecast suggests the company will make a profit of UK£30.9m in 2025. Average annual earnings growth of 75% is required to achieve expected profit on schedule. Breakeven Date Change • Dec 20
No longer forecast to breakeven The 3 analysts covering Shield Therapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of UK£12.9m in 2024. New consensus forecast suggests the company will make a loss of UK£2.89m in 2024. Breakeven Date Change • Nov 16
No longer forecast to breakeven The 4 analysts covering Shield Therapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of UK£12.9m in 2024. New consensus forecast suggests the company will make a loss of UK£7.74m in 2024. Aankondiging • Nov 01
Shield Therapeutics plc Announces Regulatory Pathway and Timelines for Accrufer® Approval in the Republic of Korea Shield Therapeutics plc announced that the Korean Food and Drug Administration has agreed that a single pharmacokinetic (PK) study is the only additional study requirement to support a New Drug Application (NDA) submission for Accrufer®. The study is expected to be initiated in fourth quarter 2022 and will be conducted by the company's partner, Korea Pharma Co. Ltd. (Korea Pharma), who have development and commercialisation rights for Accrufer® in the Republic of Korea. Korea Pharma expects regulatory approval allowing the commercial launch of Accrufer® in the Republic of Korea in late 2023. Aankondiging • Oct 27
Shield Therapeutics plc Announces That Shelf-Life for Accrufer® Extended to 48 Months Shield Therapeutics plc announced that US Food and Drug Administration ('FDA') has approved the extension of the expiration for Accrufer® (ferric maltol) from 36 months to 48 months. Breakeven Date Change • Oct 24
No longer forecast to breakeven The 4 analysts covering Shield Therapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of UK£12.9m in 2024. New consensus forecast suggests the company will make a loss of UK£7.74m in 2024. Reported Earnings • Sep 09
First half 2022 earnings released: UK£0.05 loss per share (vs UK£0.04 loss in 1H 2021) First half 2022 results: UK£0.05 loss per share (further deteriorated from UK£0.04 loss in 1H 2021). Revenue: UK£2.03m (up 322% from 1H 2021). Net loss: UK£11.8m (loss widened 62% from 1H 2021). Revenue is forecast to grow 103% p.a. on average during the next 3 years, compared to a 4.0% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 56% per year whereas the company’s share price has fallen by 60% per year. Aankondiging • Sep 01
Shield Therapeutics plc to Report First Half, 2022 Results on Sep 08, 2022 Shield Therapeutics plc announced that they will report first half, 2022 results on Sep 08, 2022 Aankondiging • Jul 14
Shield Therapeutics plc Announces New Drug Submission Accepted by Health Canada Shield Therapeutics plc announced that Health Canada have screened and accepted the Accrufer® New Drug Submission, filed by Shield's Licensing Partner, KYE Pharmaceuticals Inc. earlier this year. Health Canada are expected to complete their regulatory review in mid-2023 and a successful outcome will allow KYE to marketAccrufer®in Canada. Shield will be responsible for all manufacturing and supply to the Canadian market. Upon regulatory approval of Accrufer® by Health Canada, Shield is due to receive a £250,000 milestone payment. In addition, Shield would be eligible for an additional £600,000 in milestone payments upon the achievement of specified calendar net sales targets. For the term of the agreement, Shield will also receive double-digit royalties on net sales of Accrufer®. Reported Earnings • Jul 01
Full year 2021 earnings released: UK£0.09 loss per share (vs UK£0.022 loss in FY 2020) Full year 2021 results: UK£0.09 loss per share (down from UK£0.022 loss in FY 2020). Net loss: UK£19.3m (loss widened UK£16.7m from FY 2020). Over the next year, revenue is forecast to grow 446%, compared to a 7.5% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 12 percentage points per year, which is a significant difference in performance. Aankondiging • Jun 30
Shield Therapeutics plc, Annual General Meeting, Jul 27, 2022 Shield Therapeutics plc, Annual General Meeting, Jul 27, 2022, at 13:00 Coordinated Universal Time. Location: at the offices of Shield Therapeutics plc Northern Design Centre, Baltic Business Quarter, Gateshead Quays England United Kingdom Aankondiging • Jun 29
Shield Therapeutics plc to Report Fiscal Year 2021 Results on Jun 30, 2022 Shield Therapeutics plc announced that they will report fiscal year 2021 results on Jun 30, 2022 Breakeven Date Change • May 09
Forecast breakeven date pushed back to 2024 The 4 analysts covering Shield Therapeutics previously expected the company to break even in 2023. New consensus forecast suggests the company will make a profit of UK£33.2m in 2024. Average annual earnings growth of 68% is required to achieve expected profit on schedule. Executive Departure • Oct 07
Executive Director Timothy Watts has left the company On the 30th of September, Timothy Watts was replaced as CEO by Gregory Madison after 1.1 years in the role. As of June 2021, Timothy still personally held 1.00m shares (€590k worth at the time). Timothy is the only executive to leave the company over the last 12 months. The current median tenure of the management team is less than a year, which is considered inexperienced in the Simply Wall St Risk Model. Under Timothy's leadership, the company delivered a total shareholder return of -39%. Reported Earnings • Aug 21
First half 2021 earnings released: UK£0.04 loss per share (vs UK£0.027 profit in 1H 2020) First half 2021 results: Net loss: UK£7.28m (down 333% from profit in 1H 2020). Over the last 3 years on average, earnings per share has increased by 17% per year whereas the company’s share price has increased by 14% per year. Aankondiging • Jun 25
Shield Therapeutics plc Confirms to Launch Accrufer® in the US on July 1, 2021 Shield Therapeutics plc confirmed that, in line with prior guidance, it will launch Accrufer® in the US on July 1, 2021. Launch stocks of Accrufer® are currently being distributed through the wholesaler channels and will be available to doctors and other prescribers in all parts of the US by July 1, 2021. A sales force including 30 sales representatives has been recruited and trained and will be starting to contact key prescribers during next week. Aankondiging • May 28
Shield Therapeutics (Stx): Accrufer Launch on Schedule Shield Therapeutics (Shield) with an initial focus on treating iron deficiency (ID). Feraccru(R)/Accrufer(R) has been approved by the regulators in both Europe and the US. Following completion of a capital increase in March 2021 to raise the necessary funds, momentum has picked up significantly in preparing for the US launch of Accrufer, which is due around the end of June. Even on conservative forecasts with respect to the speed and quantum of market penetration, Shield is forecast to become profitable in 2023. Aankondiging • May 21
Shield Therapeutics plc Confirms It Remains on Track to Launch Accrufer® in the US by End of June 2021 Shield Therapeutics plc provides an update on its preparations to launch Accrufer® in the US, confirming the Group remains on track to launch by end of June 2021. Since the fundraise in mid-March 2021, preparatory work has accelerated dramatically. There are five key workstreams underway which are addressed in turn below. Working in conjunction with a well-established contract sales organisation have designed and contracted a scalable sales team that will be working to build awareness and educate health care providers on the clinical value of Accrufer®. This sales organisation will be 100% dedicated to the promotion of Accrufer®. The company are planning to launch initially with 30 sales representatives and are now in the process of hiring them. The recruitment should be completed by early June and the representatives will then be trained and ready to promote Accrufer® at launch. The purpose of medical affairs is to provide scientific and clinical support about Accrufer® to the medical community. The company have developed the necessary materials which will be made available to healthcare professionals online and through a team of medical science liaison (MSL) employees. The company plan to run several Advisory Board meetings targeted at relevant specialists and Key Opinion Leaders. The Advisory Board meetings are planned to take place between late May and mid-July. Market access covers price setting and discounting with US payers which include private insurance plans and the Federal Medicare and Medicaid plans. It also includes mechanisms to support patients by reducing patient co-pay requirements. The headline price of a pharmaceutical product in the US is known as the Wholesaler Acquisition Cost (WAC) and for Accrufer® this has been set at $500 per pack (which contains 30 days' supply at two capsules per day) and has now been published by First Data Bank and Red Book. National Account Managers are already actively engaging payer organisations to provide their patients access to Accrufer®. This process is underway but it will take 12-18 months before have comprehensive coverage across a large proportion of payers and sales forecasts in the early months take account of this. Aankondiging • May 18
Shield Therapeutics plc Announces Study Results in Inflammatory Bowel Diseases Shield Therapeutics plc noted the recent publication in the journal Inflammatory Bowel Diseases of positive long-term results from a study comparing the effectiveness of ferric maltol 30 mg bid with intravenous (IV) iron (ferric carboxymaltose given according to each centre's standard practice) over 52 weeks. The primary endpoint was haemoglobin responder rate (=2 g/dL increase or normalization) at week 12, with a 20% noninferiority limit in the intent-to-treat and per protocol populations. The open label Phase 3B study included adults with non-severe active IBD and iron-deficiency anaemia (IDA) and who also had serum ferritin levels below 30 µg/L or ferritin levels below 100 µg/L and transferrin saturation below 20%. The report of this first comparative trial, reflecting real-world conditions in patients with quiescent or mild to moderate IBD and mild to severe IDA, concluded that both oral ferric maltol and standard regimens of IV ferric carboxymaltose achieved clinically meaningful increases in Hb over 12 weeks of treatment, although ferric maltol did not meet the prespecified noninferiority margin vs IV iron. Over the longer term, ferric maltol showed comparable efficacy in maintaining Hb improvements and increasing ferritin up to week 52, consistent with IV iron. The safety profile of each treatment was consistent with previous studies. Reported Earnings • May 01
Full year 2020 earnings released: UK£0.02 loss per share (vs UK£0.075 loss in FY 2019) The company reported a solid full year result with reduced losses, improved revenues and improved control over expenses. Full year 2020 results: Revenue: UK£10.4m (up UK£9.67m from FY 2019). Net loss: UK£2.63m (loss narrowed 70% from FY 2019). Over the last 3 years on average, earnings per share has increased by 78% per year but the company’s share price has only increased by 38% per year, which means it is significantly lagging earnings growth. Aankondiging • Mar 19
Shield Therapeutics plc has completed a Follow-on Equity Offering in the amount of £4.183919 million. Shield Therapeutics plc has completed a Follow-on Equity Offering in the amount of £4.183919 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 13,946,397
Price\Range: £0.3
Transaction Features: Regulation S Aankondiging • Mar 10
Shield Therapeutics plc Announces Australia's Therapeutic Goods Administration Approves Feraccru to Treat Iron Deficiency with or Without Anaemia in Adults Shield Therapeutics plc noted that Australia's Therapeutics Goods Administration has registered Feraccru® in the Australian Register of Therapeutic Goods to treat iron deficiency with or without anaemia in adults. Feraccru® is already approved in the UK, European Union, Switzerland and United States for the treatment of iron deficiency with or without anaemia in adults. Norgine Pty Ltd. will lead all marketing activities in Australia. The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for medicinal products (therapeutic goods). Recent Insider Transactions • Mar 07
Independent Non Executive Chairman recently bought €87k worth of stock On the 5th of March, Hans-Peter Hasler bought around 200k shares on-market at roughly €0.43 per share. This was the largest purchase by an insider in the last 3 months. Hans-Peter has been a buyer over the last 12 months, purchasing a net total of €153k worth in shares. Is New 90 Day High Low • Mar 02
New 90-day low: €0.49 The company is down 59% from its price of €1.19 on 02 December 2020. The German market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 4.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €76.79 per share. Aankondiging • Feb 27
Shield Therapeutics plc has completed a Follow-on Equity Offering in the amount of £25 million. Shield Therapeutics plc has completed a Follow-on Equity Offering in the amount of £25 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 83,333,333
Price\Range: £0.3
Transaction Features: Regulation S; Subsequent Direct Listing Recent Insider Transactions • Jan 21
CEO & Director recently bought €68k worth of stock On the 19th of January, Timothy Watts bought around 100k shares on-market at roughly €0.68 per share. In the last 3 months, they made an even bigger purchase worth €76k. Timothy has been a buyer over the last 12 months, purchasing a net total of €144k worth in shares. Is New 90 Day High Low • Jan 12
New 90-day low: €0.55 The company is down 62% from its price of €1.44 on 14 October 2020. The German market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 12% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €4.13 per share. Recent Insider Transactions • Dec 15
CEO & Director recently bought €76k worth of stock On the 11th of December, Timothy Watts bought around 100k shares on-market at roughly €0.76 per share. This was the largest purchase by an insider in the last 3 months. This was Timothy's only on-market trade for the last 12 months. Is New 90 Day High Low • Dec 11
New 90-day low: €1.13 The company is down 1.0% from its price of €1.14 on 11 September 2020. The German market is up 2.0% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Pharmaceuticals industry, which is down 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €6.24 per share. Is New 90 Day High Low • Oct 19
New 90-day high: €1.67 The company is up 66% from its price of €1.01 on 21 July 2020. The German market is flat over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is down 11% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €4.73 per share. Is New 90 Day High Low • Sep 19
New 90-day high: €1.51 The company is up 52% from its price of €0.99 on 19 June 2020. The German market is up 6.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is down 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €4.11 per share. Reported Earnings • Sep 18
First half earnings released Over the last 12 months the company has reported total losses of UK£1.49m, with earnings decreasing by UK£3.49m from the prior year. Total revenue was UK£9.21m over the last 12 months, down 22% from the prior year.