New Risk • Mar 14
New major risk - Revenue and earnings growth Earnings have declined by 4.1% 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 (26% average weekly change). Earnings have declined by 4.1% per year over the past 5 years. Shareholders have been substantially diluted in the past year (448% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (UK£9.92m market cap, or US$12.8m). New Risk • Jan 21
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 448% 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 (21% average weekly change). Shareholders have been substantially diluted in the past year (448% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (UK£4.5m net loss next year). Market cap is less than US$100m (UK£19.8m market cap, or US$24.3m). New Risk • Dec 19
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: UK£7.59m (US$9.51m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-UK£6.6m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (UK£7.59m market cap, or US$9.51m). Minor Risk Currently unprofitable and not forecast to become profitable next year (UK£4.5m net loss next year). New Risk • Sep 26
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£6.6m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-UK£6.6m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (UK£7.05m market cap, or US$9.45m). Minor Risk Currently unprofitable and not forecast to become profitable next year (UK£4.5m net loss next year). New Risk • Sep 16
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (15% average weekly change). Revenue is less than US$1m. Minor Risks Latest financial reports are more than 6 months old (reported December 2023 fiscal period end). Currently unprofitable and not forecast to become profitable over next 2 years (UK£3.0m net loss in 2 years). Market cap is less than US$100m (UK£8.16m market cap, or US$10.7m). Announcement • Sep 05
Synairgen plc Announces Stepping Down of Phillip Monk from the Board, Effective December 31, 2024 Synairgen plc announced that, following 18 years of service, Dr. Phillip Monk is stepping down from the Board and will leave the Company on December 31, 2024. With Synairgen's resources dedicated to the clinical development of SNG001, Dr. Marcin Mankowski became the Company's Chief Medical Officer in 2023 and will continue to lead the clinical development strategy for SNG001. The Company looks forward to announcing further Board changes ahead of hosting its Annual General Meeting in early October. New Risk • Aug 07
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: UK£7.34m (US$9.31m) 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 Share price has been highly volatile over the past 3 months (15% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (UK£7.34m market cap, or US$9.31m). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (UK£3.0m net loss in 2 years). New Risk • Apr 11
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of British stocks, typically moving 12% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings have declined by 37% 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 June 2023 fiscal period end). Market cap is less than US$100m (UK£15.2m market cap, or US$19.0m). New Risk • Apr 08
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 37% 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 June 2023 fiscal period end). Share price has been volatile over the past 3 months (8.9% average weekly change). Market cap is less than US$100m (UK£9.83m market cap, or US$12.4m). New Risk • Nov 28
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 Share price has been highly volatile over the past 3 months (14% average weekly change). Earnings have declined by 37% per year over the past 5 years. Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (UK£19.7m market cap, or US$25.1m). Announcement • Oct 05
Synairgen plc Announces Appointment of Dr. Marcin Mankowski as Chief Medical Officer Synairgen plc announces the appointment of Dr. Marcin Mankowski as Chief Medical Officer (CMO), effective immediately. Marcin is a seasoned pharmaceutical physician and drug developer with more than 27 years of pharmaceutical industry experience and a strong background in infectious diseases and respiratory medicine. Marcin joins Synairgen on a full-time basis having worked with the Company as acting CMO and a clinical trials consultant since 2018. Prior to joining Synairgen, Marcin was Co-Founder and Chief Executive Officer at tranScrip Ltd, a leading contract drug development business, where he played an integral strategic role in both driving investment as well as leading a vast range of projects across all stages of drug development and multiple therapy areas. Announcement • May 25
Synairgen plc, Annual General Meeting, Jun 29, 2023 Synairgen plc, Annual General Meeting, Jun 29, 2023, at 09:00 Coordinated Universal Time. Location: Numis, 45 Gresham Street, London EC2V 7BF London United Kingdom Announcement • Dec 24
Synairgen plc Announces the Online Publication of Data from Its Phase 3 Sprinter Trial in the Peer Reviewed European Respiratory Journal Open Research Synairgen plc announces the online publication of data from its Phase 3 SPRINTER trial in the peer reviewed European Respiratory Journal Open Research(ERJOR).Topline results from this global, double-blind, placebo-controlled trial were first shared in February 2022, with the data analysis presented at the American Thoracic Society International Conference in San Francisco in May 2022. While the SPRINTER trial did not meet the primary endpoints of discharge from the hospital and recovery, there was an encouraging signal in reduction in the relative risk (RRR) of progression to severe disease or death within 35 days (25.7% reduction in the Intention-to-Treat population and 36.0% reduction in the Per Protocol population). SNG001 was well tolerated as has been seen in previous clinical trials. Announcement • Dec 01
Synairgen plc Appoints Amanda Radford FCA to the Board as an Independent Non-Executive Director and Chair of the Audit Committee Synairgen plc announced the appointment of Amanda Radford FCA to the board as an independent non-executive director and chair of the audit committee. Amanda is an internationally experienced finance leader with substantial listed company expertise and is currently the Group Financial Controller of BSI Group. Over the course of her career, Amanda has held senior finance roles in a number of public companies and has signi. Price Target Changed • Nov 16
Price target decreased to UK£2.20 Down from UK£7.60, the current price target is provided by 1 analyst. New target price is 1,157% above last closing price of UK£0.17. Stock is down 90% over the past year. The company is forecast to post a net loss per share of UK£0.12 next year compared to a net loss per share of UK£0.24 last year. Board Change • Nov 16
No independent directors There is 1 new director who has joined the board in the last 3 years. The new board member was not an independent director. The company's board is composed of: 1 new director. 2 experienced directors. 7 highly experienced directors. No independent directors (8 non-independent directors). Non-Executive Director Flic Gabbay was the last director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Insufficient board refreshment. Announcement • Oct 05
Synairgen plc Announces Topline Data for Participants Treated with Sng001 in the Us National Institutes of Health (Nih)/ Aids Clinical Trials Group (Actg)-Led Activ-2 Phase 2 Adaptive Platform Trial for Covid-19 Synairgen plc announced topline data for participants treated with SNG001 in the US National Institutes of Health (NIH)/AIDS Clinical Trials Group (ACTG)-led ACTIV-2 Phase 2 adaptive platform trial for COVID-19. Between February and August 2021, 221 symptomatic, non-hospitalised adult participants with COVID-19 were enrolled in the Phase 2 SNG001 evaluation and randomised between active drug (N=110 treated) and placebo (N=110 treated[1]), across 25 US sites. There were no statistically significant differences between SNG001 and placebo with respect to the primary outcomes of safety (SNG001 was well-tolerated), symptom resolution, or virology. Fewer participants required hospitalisation following treatment with SNG001 (N=1/110, [1%]) compared to placebo (N=7/110, [6%]),an 86% relative risk reduction, that was not statistically significant (P=0.07; two-sided Fisher's exact test). There were no deaths in either arm. There were 13 participants with treatment-emergent Grade 3 or higher Adverse Events (AE) with four on SNG001 [3.6%] and nine on placebo [8.2%]. Based on the study results, the Independent Data Safety Monitoring Board for ACTIV-2 recommended SNG001 advance from Phase 2 into Phase 3 in the ACTIV-2 trial in October 2021. Later, in March 2022, the NIH decided to halt all participant recruitment in the trial due to the significant shift in the nature of the pandemic which would necessitate a substantial modification of the study design which was not feasible in a multiple treatment-arm platform trial of this size. Announcement • Sep 29
Synairgen plc Announces Changes to Its Board Synairgen plc announced the appointment of Dr Felicity (Flic) Gabbay to the Board as Non-Executive Director. Theodora Harold is stepping down from the Board with immediate effect. Flic has extensive experience within the life sciences sector including holding several senior and CEO positions in big pharma, biotech and CROs in both Europe and North America. As Founder and Managing Partner at TranScrip LLP, founded in 2008, she has overseen drug development work with companies at all stages of the drug development cycle, as well as securing private equity investment and the acquisition of Real Regulatory. Starting Felicity career as a medical doctor, Flic held various medical posts across Europe before moving into the biotechnology sector. She is the current President of the Faculty of Pharmaceutical Medicine for the three Royal Colleges of Physicians. In 2020, Flic was awarded the Fellowship of the Academy of Medical Science and is passionate about bringing pharmaceutical medicine into mainstream medical science and its application to public health. Felicity completed a BSc in Pharmacology and a Bachelor of Medicine and Surgery degree at the University of Manchester. Announcement • Sep 21
Synairgen plc to Present 60 and 90-Day Long COVID Data from Phase 3 SPRINTER Study in Hospitalised COVID-19 Patients at IDWeek 2022 Synairgen plc announced it will present its positive findings from the analysis of data from 60 and 90-day follow-up visits from the Phase 3 SPRINTER trial in patients hospitalised with COVID-19 at IDWeek 2022 to be held 19-23 October 2022 in Washington, D.C. The analysis shows that when compared to placebo, SNG001 reduced the relative risk of recognised symptoms of Long COVID at day 60 and/or day 90: The full analysis, including several patient-reported outcome measures, which is ongoing, will be presented in October at IDWeek 2022 and submitted for publication in a peer-reviewed journal. SNG001 is not approved for use anywhere in the world. The SPRINTER trial (SG018; NCT04732949) was a global Phase 3, randomised, placebo-controlled, double-blind, clinical trial assessing the efficacy and safety of inhaled SNG001 on top of standard of care (SOC) for the treatment of adults hospitalised due to COVID-19 requiring treatment with supplemental oxygen by mask or nasal prongs. Patients requiring high-flow nasal oxygen therapy, non-invasive ventilation, or endotracheal intubation (invasive ventilation) at randomisation were excluded. COVID-19 was confirmed using a validated molecular test for the presence of the SARS-CoV-2 virus. Patients were randomised to receive SNG001 (N=314) or placebo (N=309) once daily for 14 days, plus standard-of-care. Long-COVID symptoms (checklist) were assessed as a secondary endpoint at follow-up visits via telephone/video call on Day 60 and Day 90. The PRO measures assessed were: General Anxiety Disorder 7 Questionnaire (GAD-7), Patient Health Questionnaire-9 (PHQ-9), Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale and Brief Pain Inventory (Short Form). SNG001 is a pH-neutral formulation of interferon-beta (IFN-beta) for inhalation that is delivered directly into the lungs using a mesh nebuliser, which the Company is developing as a potential host-directed antiviral treatment for patients hospitalised with severe viral lung infections, including COVID-19. SNG001 has broad potential applicability for patients hospitalised with respiratory symptoms due to viral infections such as SARS-CoV-2, complicated influenza, RSV, adenovirus, para-influenza and rhinoviruses. Viruses have been shown to suppress the production of IFN-beta, a naturally occurring protein that orchestrates the body's antiviral defences, with the aim of evading host immune responses. By administering IFN-beta into the lungs, the aim is to correct this deficiency, potentially switching back on the lungs' antiviral pathways to clear the virus. SNG001 has been shown to demonstrate potent in vitro antiviral activity against a broad range of viruses including SARS-CoV-2 and Alpha, Beta, Gamma, Delta and Omicron variants. Announcement • Sep 08
Synairgen Announces Positive Findings from Analysis of Lung Samples from the SG015 Trial of SNG001 in Virally Infected COPD Patients Synairgen plc announces positive data from additional assessments of lung sputum samples from its Phase 2 clinical trial of inhaled SNG001 in Chronic Obstructive Pulmonary Disease (COPD) patients with a confirmed respiratory viral infection (SG015, NCT03570359). In early 2020, due to the emergence of SARS-CoV-2, Synairgen’s SG015 trial in COPD patients was paused with 109 out of the targeted 120 patients recruited. An interim analysis of the data was reported in September 2020 which demonstrated that SNG001 boosted lung antiviral responses as assessed using sputum biomarkers, and led to a significant difference in the lung function of exacerbating patients. Sputum samples were collected where possible at study visits conducted during and after the 14-day dosing period. Assessment of viral clearance focused on the most frequently detected virus, human rhinovirus (HRV), which accounted for approximately 50% of infections. The results suggest that HRV was cleared more rapidly in patients treated with SNG001 than placebo with a statistically significant difference in the proportion of patients with detectable HRV in sputum at Day 7. In COPD exacerbations, sputum purulence and elevated levels of serum C-reactive protein (CRP) are associated with the presence of bacteria in the lower respiratory tract. In the second week of treatment, a greater proportion of patients in the placebo group had purulent sputum or elevated serum CRP. Announcement • Sep 05
Synairgen plc Announces Collaboration on Universal Trial Synairgen plc announced its collaboration on the UNIVERSAL trial, an observational study being led by the Clinical Trials Unit of the University of Southampton to explore and better understand the varied nature of acute respiratory viral infection and recovery seen in patients admitted to hospital with respiratory symptoms. The Understanding Infection, Viral Exacerbation and Respiratory Symptoms at Admission-Longitudinal (UNIVERSAL) trial seeks to develop a prospective longitudinal clinical database of respiratory viral infections in hospitalised patients to inform the development of potential antivirals to treat severe viral lung infections caused by seasonal viruses and emerging viral threats. Patients admitted to hospital due to a range of different respiratory viruses will be sampled to determine the clinical and biological predictors of progression of disease, recovery and length of hospital stay. As an observational study, no treatments are being investigated. The trial, which aims to recruit 1,000 patients, will be initiated at 10 sites across the UK following enrolment of its first patient which occurred on 1 September 2022. Viral testing equipment already owned by Synairgen and nursing staff at the Southampton clinical trial site are being provided by Synairgen, funding for the trial is being provided by Janssen. Announcement • Jun 07
Synairgen plc, Annual General Meeting, Jun 30, 2022 Synairgen plc, Annual General Meeting, Jun 30, 2022, at 08:00 Coordinated Universal Time. Location: Fieldfisher LLP, 9th Floor, Riverbank House, 2 Swan Lane London United Kingdom Announcement • May 18
Synairgen Presents Detailed Analysis of Phase 3 Sprinter Trial Evaluating Sng001 in Hospitalised Covid-19 Patients At ATS 2022 Synairgen plc announces the first presentation of the full data analysis from its Phase 3 SPRINTER trial evaluating the efficacy and safety of SNG001 in patients hospitalised with COVID-19. SPRINTER (SG018; NCT04732949) was a global, randomised, placebo-controlled, double-blind clinical trial assessing the efficacy and safety of inhaled SNG001 for the treatment of adults hospitalised due to COVID-19 who required treatment with supplemental oxygen. The trial recruited a total of 623 patients who were randomised to receive SNG001 (n=309) or placebo (n=314) on top of standard of care (SOC). The data from this pivotal trial will be presented at the Clinical Trials Symposium of the American Thoracic Society 2022 (ATS 2022) International Conference, being held in San Francisco, California from 13-18 May 2022. A separate poster presentation is scheduled for 17 May 2022. Synairgen announced in February 2022 that the Phase 3 SPRINTER trial did not meet the primary endpoints of discharge from hospital and recovery. There was, however, an encouraging signal in reduction in the relative risk (RRR) of progression to severe disease or death within 35 days (25.7%1 reduction in the Intention-to-Treat population and 36.3% reduction in the Per Protocol population). To assess the strength of this signal and identify specific patient populations that might benefit most from treatment, post hoc analyses were performed on groups of patients recognised to be at greater risk of developing severe disease in hospital. These analyses included patients =65 years old, those with co-morbidities associated with worse COVID-19 outcomes, and those who, at baseline, despite receiving low flow oxygen, had clinical signs of compromised respiratory function (defined as oxygen saturation of = 92% or respiratory rate = 21 breaths/min). These analyses showed stronger treatment effects with SNG001 in these high-risk patient sub-groups, with the strongest effect observed in those who had clinical signs of compromised respiratory function. In these patients, who represented approximately one-third of the SPRINTER trial population, SNG001 significantly reduced the risk of progression to severe disease and death compared to placebo by 70% in the Per Protocol population (Odds Ratio (95% Confidence Interval) 0.23 (0.06, 0.98); p=0.046). SNG001 was well tolerated in the SPRINTER trial with a favourable safety profile consistent with previous studies: The proportion of patients with any treatment-emergent adverse events (TEAE) related to study treatment was 22.6% for SNG001 vs. 25.4% for placebo. The proportion of patients with any serious TEAE was 12.6% for SNG001 vs. 18.2% for placebo. The proportion of patients with a serious respiratory3 TEAE was 4.7% for SNG001 vs. 9.9% for placebo. Board Change • Apr 27
Less than half of directors are independent There is 1 new director who has joined the board in the last 3 years. The new board member was an independent director. The company's board is composed of: 1 new director. 2 experienced directors. 7 highly experienced directors. 1 independent director (7 non-independent directors). Independent Non-Executive Director Theo Harold was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Announcement • Apr 05
Synairgen plc to Report Fiscal Year 2021 Results on May 25, 2022 Synairgen plc announced that they will report fiscal year 2021 results on May 25, 2022 Announcement • Mar 04
Synairgen plc Provides Update on SNG001 in the ACTIV-2 Phase 3 Trial for COVID-19 and on SNG001 Activity Against Delta and Omicron Variants Synairgen plc announced an update on SNG001 in the ACTIV-2 Phase 3 trial for COVID-19 and on SNG001 activity against Delta and Omicron variants. ACTIV-2 Phase 3 trial for COVID-19: Due to the need to modify the study design in light of the emergence of the Omicron variant of SARS-CoV-2, the U.S. National Institutes of Health (NIH) ACTIV-2 trial team has asked Synairgen to temporarily pause activities to prepare clinical supplies for ACTIV-2 Phase 3 until the timeline for the activation of this agent in the trial is clarified. Synairgen continues to await the Phase 2 data from the U.S. NIH ACTIV-2 trial in home-based COVID-19 participants, expected by mid-year. Update on SNG001 and Delta and Omicron variants: The Company also announced that in vitro studies conducted at Viroclinics-DDL in the Netherlands have shown that SNG001 has potent antiviral activity against SARS-CoV-2 Delta and Omicron variants at concentrations that are readily achievable following inhaled delivery of interferon beta. Further SPRINTER Phase 3 analysis: As announced on 21 February 2022, Synairgen is in the process of analysing the topline and full dataset from the SPRINTER Phase 3 study in order to better understand all of the findings. The findings of this analysis will be announced without delay once complete in accordance with regulatory obligations and presented and/or published in a peer-review journal. The SPRINTER trial pointed to an encouraging trend in prevention of progression to severe disease and death (36% reduction in the pre-defined per protocol population), which the Company and its clinical advisors strongly believe merits further investigation in a platform trial which the Company is actively investigating. Price Target Changed • Feb 21
Price target decreased to UK£2.20 Down from UK£7.48, the current price target is provided by 1 analyst. New target price is 709% above last closing price of UK£0.27. Stock is down 84% over the past year. The company is forecast to post a net loss per share of UK£0.33 next year compared to a net loss per share of UK£0.095 last year. Announcement • Feb 21
Synairgen plc Announces Topline Results from Phase 3 SPRINTER trial of SNG001 Synairgen plc announced that the international Phase 3 SPRINTER trial of SNG001 in patients hospitalised with COVID-19 did not meet its primary or key secondary efficacy endpoints. SNG001 demonstrated a favourable safety profile and was well tolerated in this population. A total of 623 patients were randomised to receive SNG001 (n=309) or placebo (n=314) in addition to standard of care (SOC). The primary analysis was conducted in the intention-to-treat population. Data for the per protocol population is also shown. The PP population excludes patients with major protocol violations that may have confounded the results. Regarding the primary endpoints, patients who received SNG001 were no more likely to be discharged from hospital than patients who received placebo, and patients who received SNG001 were also no more likely to recover to 'no limitation of activities' than patients who received placebo, in both the ITT and PP populations. The evolution in standard of care over the course of the pandemic may have compromised the potential of SNG001 to show a clinical benefit in respect of the primary endpoints for this study. For the key secondary endpoints, there was a trend in favour of SNG001 for the endpoint measuring progression to severe disease or death within 35 days of randomisation with a 27% and 36% relative risk reduction, for the ITT and PP populations respectively, in the proportion of patients who were treated with SNG001 compared to patients on placebo. SNG001 was well tolerated in the SPRINTER trial with a favourable safety profile consistent with previous studies. The proportion of patients with any serious treatment-emergent adverse events was 12.3% on SNG001 and 18.2% on placebo. The proportion of patients with any treatment-emergent adverse events related to study treatment was 22.3% on SNG001 and 25.7% on placebo. Synairgen will now review the study's full dataset to better understand the detailed results and implications for development for SNG001 and will provide an update in due course. The study results will also be submitted for publication in a peer-reviewed journal. SNG001 is being investigated for possible use in COVID-19 patients at home as part of the US National Institute of Health's ACTIV-2 trial. In October 2021 Synairgen announced that SNG001 had been recommended to advance from Phase 2 into Phase 3 in this trial in mild to moderate COVID-19 patients. Announcement • Dec 08
Synairgen plc Presents In Vitro Potency Data for Interferon Beta Against SARS-CoV-2 Variants and Lung Antiviral Biomarker Data for Inhaled SNG001 at the 8th ESWI Influenza Conference Synairgen plc has presented in vitro and clinical data demonstrating antiviral activity for SNG001 in a poster and an oral presentation respectively at the 8thEuropean Scientific Working Group in Influenza (ESWI) Influenza Conference, which was held virtually 4-7 December, 2021. In the poster session, Synairgen presented in vitro data demonstrating that SNG001, formulation of the naturally-occurring antiviral protein interferon beta, potently reduced virus to undetectable levels in cells infected with SARS-CoV-2 including the Alpha, Beta and Gamma variants of concern (VOC), at concentrations that are readily achievable following inhaled delivery of interferon beta. Synairgen is investigating the in vitro activity of SNG001 against the Delta and Omicron variants of SARS-CoV-2 and will make data available as soon as possible. In a separate oral session on 6 December, Dr Monk presented data showing that inhaled SNG001 significantly increased interferon beta-dependent antiviral biomarkers in the lungs of asthma and chronic obstructive pulmonary disease (COPD) patients enrolled in Phase 2 trials. Announcement • May 25
Synairgen plc Announces Results of in Vitro Studies Synairgen plc announced results from in vitro studies showing the antiviral activity of SNG001 against two SARS-CoV-2 variants. Interferon beta ('IFN-beta') is a naturally-occurring protein, which orchestrates the body's antiviral responses by triggering the production of hundreds of antiviral proteins which act across the viral replication cycle to confer broad-spectrum antiviral activity. Nebulised SNG001 is delivered directly into patients' lungs, the primary site of virus infection, to prevent severe lower respiratory tract illness caused by the SARS-CoV-2 virus. Since the first outbreak of COVID-19 in Wuhan, a number of variants of SARS-CoV-2 have emerged that are spreading globally. Changes to the virus have the potential to make it more transmissible or to enable the virus to evade the immune system, prompting concerns that some vaccines and therapeutics developed to prevent/treat COVID-19 may become less effective against certain variants. So-called variants of concern such as the Kent, South African and Indian variants have potential to halt or slow the reopening of societies despite progress with vaccination programmes. In the UK, alarm about the rapid growth of the so-called Indian variant has led to speculation that authorities may need to bring in renewed restrictions. In vitro experiments were conducted at Viroclinics-DDL in the Netherlands to confirm that SNG001 had activity against the B.1.1.7 ("UK or "Kent") and B.1.351 ("South African") variants. In these experiments, Vero E6 cells were treated with SNG001 prior to and after infection with SARS-CoV-2. 16-24 hours after infection, the presence of SARS-CoV-2 viral proteins was determined using an immunostaining method. SNG001 potently reduced virus to undetectable levels in cells infected with Wuhan-like (virus strain: Germany/BavPat1/2020), the UK/Kent variant and the South African variant. Concentrations, readily achievable following inhaled delivery of interferon beta, that gave 90% inhibition (IC--90) were 3.2, 4.0 and 3.4 IU/mL respectively. Announcement • Apr 30
Synairgen Announces Data from Home Cohort of SG016 Phase II Trial of Inhaled Interferon Beta in COVID-19 Patients and Encouraging Combined Data for Whole SG016 Trial Synairgen plc announces results from the Home Cohort of its SG016 Phase II trial of SNG001 in SARS-CoV-2 infected patients and data from the combined analysis of the Hospital and Home Cohorts. SNG001 is a formulation containing IFN-beta for nebulisation, allowing it to be delivered directly into patients' lungs. A number of studies have reported that the SARS-CoV-2 virus suppresses natural production of IFN-beta and prevents induction of anti-viral responses by infected cells. Furthermore, some people have deficiencies in antiviral IFN signalling that make them more vulnerable to spread of the virus from the nose into the lungs where it can cause severe breathing difficulties. These findings provide a rationale to deliver IFN-beta directly to the surface epithelial cells of the lungs, the primary site of virus infection in the lungs, to prevent severe lower respiratory tract illness caused by the SARS-CoV-2 virus.
Synairgen's placebo-controlled Phase II trial evaluated SNG001 for the prevention of severe lower respiratory tract (LRT) illness caused by SARS-CoV-2, determined by evaluating change in condition measured using the WHO Ordinal Scale for Clinical Improvement (OSCI) during the dosing period (the primary endpoint). The SG016 trial involved 221 patients in two cohorts: Hospital Cohort: 101 patients in the hospital setting, where patients on SNG001, compared to placebo were twice as likely to recover from severe LRT illness to the point where they had 'no limitation of activities' (level 1 on the OSCI) without rebound, and had reduced breathlessness. Home Cohort: 120 'at risk' (aged over 65 or over 50 with a risk factor) patients in the home setting to investigate if SNG001 could prevent development of severe LRT illness. In total, only two patients were admitted to hospital during the treatment period, both from the placebo group. The hospitalisation rate (approximately 3% in the placebo group) in this 'at risk' COVID-19 patient population was lower than had been originally anticipated, but is in line with other recent large peer-reviewed therapeutic studies.2 Consequently, the prevention of severe LRT illness could not be determined. The majority of patients exhibited only mild disease which believe compromised the possibility of showing treatment effects in the Home Cohort. Therefore decided to analyse the subset of patients with most severe symptoms. A post hoc analysis was conducted focusing on the 12% of patients who had significant breathlessness (marked or severe, as defined in Note a) at the time they began treatment. In these patients, the recovery to level 1 on the OSCI ('no limitation of activities') followed a similar pattern to that observed previously in the hospital population where SNG001 accelerated recovery. This led to an analysis of the impact of SNG001 across the Home and Hospital Cohorts in breathless patients. A combined analysis of the Hospital and Home Cohorts data was conducted to explore the impact of the different levels of breathlessness, which is one of the most prominent symptoms of COVID-19, on time to recovery. An assessment of placebo patients only indicated that those with marked or severe breathlessness at time of treatment initiation had slower recovery to no limitation of activities than those patients who were not as breathless. In the Hospital Cohort (reported in July 2020) patients were 2.19 times more likely to recover to level 1 on the Ordinal Scale compared to placebo, HR 2.19, p=0.043. The addition of the 12 markedly and severely breathless Home Cohort patients changes the Hazard Ratio to 2.49, p=0.009. Interestingly, not all hospitalised patients were markedly or severely breathless at time of treatment initiation. An analysis including only patients who were markedly or severely breathless at the time of treatment initiation, irrespective of whether they were in hospital or at home, showed that those treated with SNG001 (n=33) were 3.41 times more likely to recover than those on placebo (n=36) (HR 3.41 [95% confidence interval 1.47- 7.94], p=0.004). Announcement • Feb 16
Synairgen Announces Dosing Has Commenced with Its Inhaled Interferon Beta Product in US Government-Funded NIH ACTIV-2 Trial in COVID-19 Outpatients Synairgen plc announced that dosing has begun in the inhaled interferon beta formulation (SNG001) sub-study of the ACTIV-2 Phase II/III trial, evaluating patients with mild to moderate COVID-19 symptoms not yet requiring hospitalisation. If an investigational agent shows promise by demonstrating safety and reducing COVD-19 symptoms through 28 days following administration, the ACTIV-2 trial is designed to expand seamlessly from a Phase II to a Phase III study to gather additional critical data from a larger pool of volunteers without delay. Phase II sub-studies enrol up to 220 volunteers, while exact enrolment size of Phase III sub-studies will vary depending on mode of administration of the investigational agent. The adaptive nature of the ACTIV-2 trial allows for comparison of multiple interventions with a shared group of placebo recipients. In addition to safety and symptomatic efficacy signals, the sub-studies in ACTIV-2 assess whether an investigational agent can reduce the amount of SARS-CoV-2 virus detectable in the nasopharynx. Is New 90 Day High Low • Feb 16
New 90-day high: UK£1.90 The company is up 81% from its price of UK£1.05 on 18 November 2020. The British market is up 8.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 32% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is UK£9.04 per share. Is New 90 Day High Low • Jan 26
New 90-day high: UK£1.88 The company is up 5.0% from its price of UK£1.79 on 27 October 2020. The British market is up 16% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 15% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is UK£8.77 per share. Announcement • Jan 26
Synairgen Announces Inclusion of Its Inhaled Interferon Beta Treatment in US NIH ACTIV-2 trial in COVID-19 outpatients Synairgen plc announces a clinical trial agreement to include its inhaled interferon beta-1a treatment (SNG001) in the ACTIV-2/A5401 Phase II/III trial in patients with COVID-19 not yet requiring hospitalisation. The trial is sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). The Phase II/III ACTIV-2 study, led by the NIAID-funded AIDS Clinical Trials Group (ACTG), is an adaptive, randomised, blinded, placebo-controlled trial. The Phase II evaluation of SNG001 will see the recruitment of up to a maximum of 220 participants across US sites, in a home-based setting, split between SNG001 and placebo, and a positive result enables progression into the Phase III part of the study. NIAID is the regulatory sponsor and holder of the Investigational New Drug application to conduct the ACTIV-2 study, which is funded by Operation Warp Speed, a partnership led by the US Department of Health and Human Services through NIAID, to investigate and coordinate the development, manufacturing, and distribution of COVID-19 diagnostics, therapeutics and vaccines. Announcement • Jan 22
Synairgen plc Announces Completion of Recruitment into Its Phase Ii Home-Based Covid-19 Study of Inhaled Interferon Beta Synairgen plc announced that recruitment of 120 COVID-19 patients into its Phase II trial evaluating inhaled formulation of interferon-beta-1a (SNG001) conducted in the home setting has now been completed. Results from the trial are expected in Second Quarter 2021. Synairgen’s two-part, placebo-controlled trial evaluating SNG001 as a treatment for COVID-19 infection involved dosing of 101 patients in the hospital setting, the positive results from which were published in The Lancet Respiratory Medicine in November 20201, and 120 ‘at risk’ patients in the home setting, recruitment for which completed yesterday. The study targeted patients with a positive SARS-CoV-2 test result aged over 65, and those over the age of 50 with 'high risk' medical conditions. The trial was designed to make it easy and safe for trial participants and researchers to conduct the study; all supplies were delivered directly to the patient's door by a courier, and all trial assessments were conducted remotely by study doctors and nurses via video call. The study has confirmed the feasibility of rapid roll-out of antiviral treatment in the context of a pandemic, where there is a need to limit the movement of people to minimise risks to patients, the public and healthcare providers. The trial was conducted in collaboration with the NIHR Southampton Clinical Trials Unit and TranScrip Partners. Announcement • Jan 13
Synairgen Announces Commencement of Dosing in Its International Phase III Study of Inhaled Interferon Beta in Hospitalised COVID-19 Patients Synairgen plc announced that the first patient has been dosed in the UK as part of its global Phase III trial (SG018) evaluating Synairgen’s inhaled formulation of interferon beta-1a (SNG001), for the treatment of hospitalised COVID-19 patients. As previously announced, Synairgen has appointed Parexel Biotech, to help conduct the Phase III trial and several UK sites have now been initiated, with further sites in the US and the EU expected to follow. The trial is deemed an Urgent Public Health study by the UK’s National Institute for Health Research (NIHR). In the US, SNG001 has been granted Fast Track status from the US Food and Drug Administration (FDA). The Company is seeking further equivalent prioritisations and support from governments in participating countries. Synairgen’s SG018 trial is a randomised placebo-controlled study being conducted in approximately 20 countries enrolling a total of 610 COVID-19 patients who require supplemental oxygen. After reporting the results for the primary and key secondary endpoints of the study, enrolled patients will continue to be assessed for long-COVID-19 symptoms. Announcement • Dec 19
Synairgen plc Provides COVID-19 Clinical Programme Update Synairgen plc announced updates to the Company’s Phase III trial design evaluating SNG001 as a treatment for patients with COVID-19 and positive progress on the regulatory path. Initiation of the first SG018 sites has commenced in the UK, with dosing expected to commence imminently. The SG018 trial was deemed an Urgent Public Health study and recognised as a National Priority by the National Institute for Health Research (NIHR) in October 2020. Synairgen’s Investigational New Drug (IND) application to the FDA to evaluate SNG001 as a treatment for patients with COVID-19, has been cleared, enabling Synairgen to initiate its SG018 trial in the US. Furthermore, the FDA has awarded SNG001 Fast Track status, enhancing the ability of Synairgen to interact with the FDA and shortening review timelines. This trial targets patients with a positive SARS-CoV-2 test result who are aged over 65 and those over the age of 50 with ‘high risk’ medical conditions. It is a trial designed to make it easy and safe for trial participants and researchers to conduct the research; all supplies for the trial are delivered directly to the patient’s door by courier, and all trial visits and assessments are conducted virtually by video call. After a slow start in the summer, recruitment and dosing are now progressing well with a noticeable increase in the last two months. Is New 90 Day High Low • Dec 04
New 90-day low: UK£0.77 The company is down 61% from its price of UK£2.00 on 04 September 2020. The British market is up 11% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs 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 UK£7.78 per share. Announcement • Oct 04
Clinigen Group plc Signs Managed Access Program Agreement with Synairgen plc Synairgen plc and Clinigen Group plc have signed an agreement to launch a Managed Access Program for Synairgen's inhaled formulation of interferon beta (IFN-beta), SNG001, in the UK and the EU for the treatment of hospitalised COVID-19 patients. SNG001 is an inhaled formulation of IFN-beta for direct delivery to the lungs via nebulisation. Synairgen announced positive topline data generated from 101 patients hospitalised with COVID-19 in its phase II trial, SG016, on the 20 July 2020. The trial of SNG001 in hospitalised patients produced very encouraging findings; patients who received SNG001 were more than twice as likely to recover over the course of the treatment period compared to those receiving placebo. Synairgen is currently in discussions with regulatory agencies to progress this potential COVID-19 treatment. 