Southampton, UK – 27 April 2023: Synairgen plc (LSE: SNG), the respiratory company developing SNG001, an investigational formulation for inhalation containing the broad-spectrum antiviral protein interferon beta, today announces its preliminary statement of audited results for the year ended 31 December 2022.
Highlights (including post period-end)
Operational
Completed further analysis of data accumulated from the more than 750 patients dosed to date with SNG001. Findings included:
- Development of stratification criteria to target specific populations in future trials;
- SNG001 reduced the risk of several recognised Long COVID symptoms;
- Evidence of accelerated viral clearance of rhinovirus from the lung in COPD patients; and
- Further demonstration of the well-tolerated safety profile of SNG001.
Announced data from the US NIH-led ACTIV-2 Phase 2 trial for SNG001 in COVID-19 which showed an encouraging reduction in hospitalisation with SNG001 versus placebo in home-based patients.
Published data from the Phase 3 SPRINTER trial for SNG001 in hospitalised COVID-19 in the European Respiratory Journal Open Research in December 2022. Data from the trial, which did not meet primary or key secondary endpoints, included the observation of an encouraging signal in the reduction in progression to severe disease or death for patients treated with SNG001.
Gained a deeper understanding of the extent of the mechanism of action of SNG001 as a host directed, variant-agnostic antiviral agent:
- Potent antiviral activity was shown in vitro against SARS-CoV-2 Alpha, Beta, Delta, Gamma and Omicron Variants of Concern, adding to our existing in vitro studies which showed potent antiviral activity against a wide variety of seasonal respiratory and pandemic viruses including RSV, rhinovirus, various influenza strains including H5N1, and MERS-CoV.
Undertook a thorough evaluation of clinical development options to map out a route to conducting a Phase 3 registrational programme required for a regulatory submission.
- Identified a clinical development plan for SNG001 designed to address the unmet need in targeted, high-risk patient populations that appear to be most responsive to SNG001 in previous clinical trials, for example elderly patients and those with certain co-morbidities.
- In addition, we plan to assess SNG001 in immunocompromised patients who are particularly vulnerable to respiratory viral infections, ventilated patients with confirmed viral pneumonia, and also those who appear unable to clear virus and become long term “shedders” and mutation hosts.
- Plan will start with a series of focused, investigator-led/Synairgen-sponsored studies, using existing resources, which are intended to lead towards a Phase 3 registrational programme. Preparation is underway for these focused trials to initiate in H2 2023.
Financial
Loss from operations for the year ended 31 December 2022 of £20.3 million (2021: £57.9 million), with R&D expenditure decreasing to £14.9 million (2021: £52.9 million).
Cash and deposit balances of £19.7 million at 31 December 2022 (31 December 2021: £33.8 million).
Richard Marsden, CEO of Synairgen, said: “2022 was an insightful year for Synairgen, pointing us towards a clear clinical development plan following analysis of the Phase 3 SPRINTER data and other important data.
“We confirmed with our clinical collaborators the significant unmet need for broad-spectrum antivirals to help address both the ongoing need to treat viral lung infections, and in preparation for future pandemics. We believe that SNG001 has the potential to help fill this important gap in respiratory treatments for high-risk patient groups and we look forward to initiating the first trials in the second half of this year.”
For further enquiries, please contact:
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MKC STRATEGIES, LLC (US Media Relations)
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Notes for Editors
About Synairgen
Synairgen is a UK-based respiratory company focused on drug discovery, development and commercialisation. The Company’s primary focus is developing SNG001 (inhaled interferon beta) for the treatment of severe viral lung infections, including COVID-19, as potentially the first host-targeted, broad-spectrum antiviral treatment delivered directly into the lungs. SNG001 has been granted Fast Track status from the US Food and Drug Administration (FDA). Founded by University of Southampton Professors Sir Stephen Holgate, Donna Davies and Ratko Djukanovic in 2003, Synairgen is quoted on AIM (LSE: SNG). For more information about Synairgen, please see www.synairgen.com.
CHAIRMAN’S STATEMENT
2022 started with high hopes for the success of our Phase 3 clinical trial of SNG001 for the treatment of COVID-19 in hospitalised patients. Unfortunately, the trial did not meet its primary endpoints, which was most likely due to improvements in standards of care and is further discussed in this report. However, the data did provide significant insights into the patient groups that appeared to benefit most from SNG001. This has enabled Synairgen to refocus on SNG001’s potential both in the hospital and the home environment as a broad-spectrum antiviral for those most at risk of severe respiratory problems. This obviously includes COVID-19, however the Group’s work in 2022 has shown that there is a significant unmet need in the broader respiratory antiviral area, in addition to the need to find potential treatment solutions for future viral pandemics. Respiratory virus infections remain a leading cause of death globally.
Working closely with our partners, including academic institutions, diagnostic and medical device companies, advisors, and our strong team of researchers, scientists and regulatory experts, and building on the substantial body of trial evidence we have for SNG001, the team spent much of the year advancing the clinical development plans to pursue this goal. These are in the process of being discussed with potential trial sites and investigators with a view to commencing later this year.
I would like to take this opportunity to thank the Board of Directors for their unwavering support during this challenging time. Their guidance and expertise have been invaluable in helping us navigate both the challenges and analysis of the opportunities. I would also like to note the retirement of Theo Harold and Iain Buchanan, both of whom have made significant contributions to Synairgen. At the same time, we are pleased to welcome Amanda Radford and Flic Gabbay to our Board of Directors. Their experience and insight will be instrumental in helping us achieve our goals.
I am proud of the dedication and hard work of our entire team in a particularly challenging year, and I am excited for our future progress in developing this novel treatment for a wide range of viral respiratory diseases.
Simon Shaw
Chairman
OPERATIONAL REVIEW
Overview
2022 was an important year for Synairgen, providing the Group with insights and data that have helped refine and clarify the potential for SNG001.
In the first quarter of 2022 the Group received the disappointing news that the Phase 3 SPRINTER trial of SNG001 in hospitalised patients with COVID-19 did not meet the trial’s primary endpoints. Following the announcement of the topline results, post hoc analyses subsequently showed positive trends in subsets of higher risk patient groups within the trial. Through this work and months of investigation, both in-house and with clinical collaborators on both sides of the Atlantic, we have established a number of ways forward for the SNG001 development programme. We are embarking on these with renewed vigour in 2023.
From a clinical perspective, alongside the safety data accumulated to date from the more than 750 patients dosed with SNG001, we gained important new insights about the specific patient populations to target in future clinical trials, particularly in relation to the potential for reducing the risk of disease progression – whether in the hospital setting or the home environment. We can also see from the SPRINTER trial that SNG001 may have a positive effect in reducing the risk of several recognised Long COVID symptoms. Finally, a further analysis during the year of the SG015 Phase 2 trial in patients with COPD showed accelerated viral clearance of human rhinovirus in patients receiving SNG001 compared to placebo.
On the non-clinical side, we learned more about the mechanism of action of SNG001 as a host directed, variant-agnostic antiviral agent. Adding to our existing in vitro studies which showed potent antiviral activity against a wide variety of seasonal respiratory and pandemic viruses including RSV, rhinovirus, various influenza strains including H5N1 and MERS-CoV, we showed potent antiviral activity in further in vitro studies against SARS-CoV-2 Alpha, Beta, Gamma, Delta and Omicron Variants of Concern.[1]
The market context is clear: there are no approved antiviral therapies for the majority of hospitalised adult patients due to respiratory viral lung infections, and the pandemic has highlighted the significant issues for health systems and patients as a result. In the US alone, approximately three million people are hospitalised every year due to viral lung infections such as rhinovirus, Respiratory Syncytial Virus (RSV), COVID-19, influenza and others.[2]
Our work in 2022 has shown that there is a significant unmet need in this broader antiviral area, in addition to the need to find potential treatment solutions for future viral pandemics. Our clinical work over many trials to date indicates that SNG001 has potential utility against a wide spectrum of respiratory viruses in certain high-risk patient groups.
Development Plan
This accumulated non-clinical and clinical data, together with third party research and feedback from the clinical community, has strengthened our conviction that SNG001 has potential as a broad-spectrum antiviral which could be directed towards certain types of patients infected with a wide range of respiratory viruses. The Synairgen team, and our collaborators and advisors, have assessed many different options for an optimal clinical development programme, and have mapped out a series of focused clinical trials to confirm the signals we have seen and investigate SNG001 against this wide spectrum of respiratory viruses in specific high-risk patient groups.
Mindful of the insights gained in 2022 and the challenges outlined, Synairgen continues to explore the potential of SNG001 in three settings:
- For use as a broad-spectrum antiviral in people hospitalised with severe viral lung infections, particularly those in high-risk groups;
- To prevent progression of disease/hospitalisation in high-risk patient groups with a range of respiratory viruses in the home setting; and
- As a possible future pandemic preparedness option for government agencies.
We are now progressing protocols specific to three main opportunities for the next stage of the development programme, namely in the patient populations identified: in the elderly (who were most at risk during the pandemic); immunocompromised (such as patients taking chemotherapy for whom even a common cold can delay effective treatment of their underlying disease); and other patients who may benefit most from the use of SNG001 (including ventilated patients with confirmed viral pneumonia and those who appear unable to clear virus and become long term “shedders” and mutation hosts). Both individually and collectively, these are significant unaddressed market opportunities.
Clinical Development Outlook
The Group and its clinical advisors believe that based on the safety data and body of pre-clinical and clinical data for SNG001 it has the potential to be the first inhaled broad-spectrum antiviral for the patients who are at high risk of disease progression.
The development of a broad-spectrum antiviral treatment has been a significant challenge in the field of antiviral research. The search for a broad-spectrum antiviral treatment can be traced back several decades, with a growing recognition of the need for a treatment that can effectively target a wide range of different viral infections.
In recent years, there has been increased recognition in the importance of developing broad-spectrum antivirals that target the host cell rather than the virus itself. However, despite this growing interest, there is currently no precedent for a broad-spectrum antiviral clinical development programme.
Many of the platform trials that emerged during the COVID-19 pandemic have completed or wound down in part due to lower rates of severe illness or changes in funding. Synairgen has been and remains in contact with the relevant platform trial investigators and will continue to evaluate options should they arise; however, in parallel, wanting to move forward at pace, we believe that implementing our own current clinical development plan as quickly as possible will provide promising opportunities to collect appropriate and meaningful data to support an eventual regulatory submission.
Over the past year, the Group has undertaken a thorough evaluation of clinical development options with the aim of conducting a Phase 3 registrational programme required for a regulatory submission. As there is no precedent for a broad-spectrum antiviral clinical development programme, designing and determining a clinical pathway is complex as there are multiple viruses being targeted for different high-risk patient groups. It has been determined that to achieve this aim, a multi-staged clinical development plan is required.
The Group is now advancing a clinical development plan for SNG001 designed to address the unmet need in targeted patient populations that appear to be most responsive to SNG001 in previous clinical trials, as well as in immunocompromised patients who are particularly vulnerable to respiratory viral infections, and also ventilated patients with confirmed viral pneumonia. This plan will start with a series of focused, investigator-led/Synairgen-sponsored studies that build a pathway towards a Phase 3 registrational programme. Preparation is underway for these focused trials to initiate in H2 2023.
Clinical Need
Severe viral lung infections can be caused by a variety of viruses, including influenza, coronaviruses, RSV, rhinovirus, and adenovirus, among others. These infections can lead to serious complications, including pneumonia, acute respiratory distress syndrome (ARDS), and death, particularly in vulnerable populations such as elderly individuals, those with COPD and asthma, and people with weakened immune systems.
In the US, severe viral lung infections are responsible for upwards of three million hospitalisations annually, at a cost of $50 billion.[3]
Current antiviral treatments are limited in their efficacy, as they are typically specific to a single virus. For example, while certain antivirals are effective against influenza, they are not effective against other viruses that can cause severe lung infections, such as coronaviruses or RSV.
This highlights the need for a broad-spectrum antiviral that can effectively treat a range of different viral lung infections, regardless of the specific virus causing the infection. A broad-spectrum antiviral would be a valuable addition to the healthcare arsenal, as it would improve outcomes for patients and reduce the spread of viral infections in healthcare settings. Additionally, a broad-spectrum antiviral would be useful in the event of a pandemic caused by a novel virus, as it would provide a treatment option even if the aetiology of the specific virus is not yet known.
In summary, the need for a broad-spectrum antiviral to treat severe viral lung infections is driven by the high incidence of severe lung infections caused by a variety of different viruses, the limited number and efficacy of current antivirals, and the potential to improve outcomes for patients and reduce the spread of viral infections.
The annual cost of hospitalisations for severe lung infections illustrates the substantial market opportunity for an effective broad-spectrum antiviral to treat such infections.
Rationale for SNG001 as a broad-spectrum antiviral
There is a strong scientific rationale underpinning SNG001 for use in treating patients infected with a broad range of respiratory viruses, combined with its safety profile and a growing body of encouraging clinical and non-clinical data which has helped us better understand the potential role SNG001 might play in treating patients at risk of developing severe illness due to these respiratory viruses.
The Group has conducted in vitro testing of SNG001 against a broad range of respiratory viruses ranging from seasonal cold and flu viruses like RSV and rhinovirus; highly pathogenic viruses such as H5N1, a form of ‘bird flu’, MERS-CoV, SARS-CoV-2 variants of concern including Alpha, Beta, Gamma, Delta and Omicron.[4] In vitro tests have shown potent antiviral activity at concentrations that are readily achievable following inhaled delivery of interferon beta. We believe these concentrations could not be accomplished at the lining of the lungs via the injected route, and indeed recent studies have shown systemic use of IFN-B through injection is ineffective in fighting COVID-19 in the lungs.[5]
2022 Clinical Summary and Progress
SPRINTER – Investigating SNG001 in the hospitalised environment
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.
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 the key secondary endpoint of reduction in the relative risk (RRR) of progression to severe disease or death within 35 days including a 25.7% reduction in the Intention-to-Treat population and 36.3% reduction in the Per Protocol population (though neither was statistically significant).
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 high-risk patient subgroups, 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 or 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).
The data from this pivotal trial was presented at the Clinical Trials Symposium of the American Thoracic Society 2022 (ATS 2022) International Conference in San Francisco, California in May 2022 and appeared in the peer-reviewed European Respiratory Journal Open Research (ERJOR) in December 2022.
In addition to this, Long COVID symptoms and patient reported outcome measures were assessed as a secondary endpoint of the SPRINTER trial at follow-up visits via telephone/video call on Day 60 and 90. Patients on SNG001 saw the relative risk of fatigue/malaise reduced [RRR=35.4%], one of the most common symptoms of Long COVID.
ACTIV-2 - Investigating antiviral treatments in the home environment
In October 2022, Synairgen received the positive topline results for outcomes through 28 days of follow-up from the Phase 2 evaluation of SNG001 from the US National Institute of Allergy and Infectious Diseases (NIAID) ACTIV-2 trial (Protocol ACTIV-2/A5401: “Adaptive Platform Treatment Trial for Outpatients with COVID-19 [Adapt out COVID]”; Appendix B). This trial was established to investigate potential therapies in adults experiencing mild to moderate COVID-19 outside of the hospital setting. Based on the study results, the Independent Data Safety Monitoring Board for ACTIV-2 recommended SNG001 advance from Phase 2 into Phase 3 but 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. At that point, the Phase 3 component, including SNG001, was halted.
Overall SNG001 was well-tolerated and there was no statistically significant difference between SNG001 and placebo with respect to the primary safety outcome measure, and there were no statistically significant differences in the other primary outcomes namely time to symptom improvement or viral clearance. It is notable that one patient was hospitalised in the SNG001 treatment group compared with seven in the Placebo group (1/110 SNG001 versus 7/110 placebo, representing an 86% relative risk reduction p=0.07). While the Phase 2 stage of the trial was not powered to prove this, the promising decrease in hospitalisations in patients that received SNG001 may be important, especially combined with a good safety profile.
The data from the ACTIV-2 trial was presented at the Conference on Retroviruses and Opportunistic Infections Conference (CROI) in February 2023 by Dr William Fischer from the University of North Carolina at Chapel Hill and have been submitted for publication in a peer-reviewed journal.
To build on the results of the ACTIV-2 trial, one of the clinical opportunities we are investigating for SNG001 is its use in the home environment to help prevent hospitalisation in high-risk patients with a wide range of viral lung infections.
SG015 COPD trial virology
In early 2020, due to the emergence of SARS-CoV-2, Synairgen's SG015 (NCT03570359) 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 a significant improvement in the lung function of exacerbating patients.
In September 2022, Synairgen reported positive data from post hoc assessments of lung sputum samples from SG015 which showed that SNG001 accelerated clearance of rhinovirus (which approximately half of the trial participants had) from the lungs. This builds on existing data supporting SNG001's mechanism of action.
Manufacturing
As we look ahead to delivering the clinical development programme, we have made the strategic decision to focus our manufacturing efforts on the supply of additional pre-filled syringe drug product and placebo for clinical trials. While we remain committed to exploring new packaging options, such as blow-filled sealed delivery, we believe that at this time it is important to prioritise the production of SNG001 to fulfil current requirements, using current proven process and materials.
FINANCIAL REVIEW
Consolidated Statement of Comprehensive Income
The loss from operations for the year ended 31 December 2022 was £20.3 million (2021: £57.9 million loss) with research and development expenditure amounting to £14.9 million (2021: £52.9 million) and other administrative expenses of £5.4 million (2021: £5.0 million).
Research and development expenditure continued to be focussed on clinical trials and manufacturing activities.
Clinical trial expenditure on SPRINTER, SG015 and SG016 reduced markedly compared to 2021. Additional preparatory costs for the ACTIV-2 Phase 3 study were incurred in 2022 prior to the trial being halted.
Manufacturing activities (including procurement of long lead time items) also reduced significantly in 2022 with the main area of expenditure being on outsourced activities, including blow fill seal drug product development, release testing, stability testing and comparison testing, with all costs being expensed to the income statement.
Other administrative expenses, which comprises all expenses which are not research and development expenditure, of £5.4 million in 2022 remained broadly in line with the total expenditure of £5.0 million in 2021. There was greater expenditure on medical affairs and corporate communications in 2022 compared to 2021 when there was a greater expenditure on pre-commercialisation activities.
Interest receivable increased from £nil to £0.2 million as deposit interest rates increased during the second half of 2022.
The research and development tax credit decreased from £9.2 million to £2.4 million in line with reduced qualifying research and development expenditure. The credit equates to 16% of our 2022 research and development expenditure (2021: 17%).
The loss after tax for 2022 was £17.6 million (2021: £48.7 million) and the basic loss per share was 8.76p (2021: basic loss per share of 24.28p).
Consolidated Statement of Financial Position and Cash Flows
At 31 December 2022, net assets amounted to £20.3 million (2021: £37.0 million), including cash and deposit balances of £19.7 million, comprising cash and cash equivalents of £15.9 million and other financial assets – bank deposits of £3.8 million, (2021: £33.8 million cash and cash equivalents).
The principal elements of the £14.1 million decrease during the year ended 31 December 2022 (2021: £41.2 million decrease) in cash and deposit balances were:
- Cash outflows from operations before changes in working capital: £19.3 million (2021: £57.2 million), with the reduction being attributable to the lower research and development expenditure as explained above;
- Changes in working capital: £4.1 million outflow (2021: £12.2 million inflow), on account of the reduction in trade and other payables as discussed below. In 2021 there was a reduction in trade and other receivables of some £7.8 million and an increase in trade and other payables of £4.4 million;
- Interest received £0.1 million (2021: £nil); and
- Research and development tax credits received: £9.1 million (2021: £3.9 million) on account of receipt of the 2021 tax credit.
The other significant changes in the Statement of Financial Position were:
- Current tax receivable decreased from £9.1 million to £2.4 million on account of the lower research and development tax credit receivable; and
- Trade and other payables decreased from £7.6 million to £3.3 million as trade payables reduced from £4.2 million to £0.5 million in line with the reduction in the level of operating expenditure.
OUTLOOK
Underpinned by the encouraging data accumulated to date for SNG001 and that respiratory virus infections remain a leading cause of death globally, we remain excited by its potential to be the first inhaled broad-spectrum antiviral for patients at high risk of disease progression, in both the hospital and home environment.
Based on the significant clinical need and the insights gained from our clinical and pre-clinical data, the Group will advance its clinical development plan for SNG001 with a series of focused, investigator-led/Synairgen-sponsored studies, commencing in H2 2023 utilising existing cash resources, to build a pathway towards a Phase 3 registrational programme.
We continue to gather valuable insights from studies conducted and look forward to presenting our latest analysis of the Phase 3 SPRINTER trial data at ISIRV and ATS in May and updating all our shareholders on our progress in due course.
Consolidated Statement of Comprehensive Income
for the year ended 31 December 2022
Year ended 31 December 2022 | Year ended 31 December 2021 | |||
Notes | £000 | £000 | ||
Research and development expenditure | (14,936) | (52,857) | ||
Other administrative expenses | (5,364) | (5,009) | ||
Total administrative expenses and Loss from operations | (20,300) | (57,866) | ||
Finance income | 207 | 11 | ||
Finance expense | - | (2) | ||
Loss before tax | (20,093) | (57,857) | ||
Tax | 2 | 2,448 | 9,194 | |
Loss and total comprehensive loss for the period attributable to equity holders of the parent | (17,645) | (48,663) | ||
Loss per ordinary share | 3 | |||
Basic and diluted loss per share (pence) | (8.76)p | (24.28)p | ||
Consolidated Statement of Changes in Equity
for the year ended 31 December 2022
Share capital | Share premium | Merger reserve | Retained deficit | Total | ||
£000 | £000 | £000 | £000 | £000 | ||
At 1 January 2021 | 1,999 | 125,245 | 483 | (42,586) | 85,141 | |
Loss and total comprehensive loss for the year | - | - | - | (48,663) | (48,663) | |
Transactions with equity holders of the Group | ||||||
Issue of ordinary shares | 14 | - | - | - | 14 | |
Recognition of share-based payments | - | - | - | 508 | 508 | |
14 | - | - | 508 | 522 | ||
At 31 December 2021 | 2,013 | 125,245 | 483 | (90,741) | 37,000 | |
Loss and total comprehensive loss for the year | - | - | - | (17,645) | (17,645) | |
Transactions with equity holders of the Group | ||||||
Issue of ordinary shares | 1 | - | - | - | 1 | |
Recognition of share-based payments | - | - | - | 919 | 919 | |
1 | - | - | 919 | 920 | ||
At 31 December 2022 | 2,014 | 125,245 | 483 | (107,467) | 20,275 | |
Consolidated Statement of Financial Position
as at 31 December 2022
31 December 2022 £000 | 31 December 2021 £000 | ||||
Assets | |||||
Non-current assets | |||||
Intangible assets | 44 | 53 | |||
Property, plant and equipment | 86 | 173 | |||
Right-of-use assets | - | - | |||
130 | 226 | ||||
Current assets | |||||
Current tax receivable | 2,415 | 9,055 | |||
Trade and other receivables | 1,308 | 1,530 | |||
Other financial assets – bank deposits | 3,750 | - | |||
Cash and cash equivalents | 15,926 | 33,827 | |||
23,399 | 44,412 | ||||
Total assets | 23,529 | 44,638 | |||
Liabilities | |||||
Current liabilities | |||||
Trade and other payables | (3,254) | (7,638) | |||
Total liabilities | (3,254) | (7,638) | |||
Total net assets | 20,275 | 37,000 | |||
Equity | |||||
Capital and reserves attributable to equity holders of the parent | |||||
Share capital | 2,014 | 2,013 | |||
Share premium | 125,245 | 125,245 | |||
Merger reserve | 483 | 483 | |||
Retained deficit | (107,467) | (90,741) | |||
Total equity | 20,275 | 37,000) | |||
Consolidated Statement of Cash Flows
for the year ended 31 December 2022
Year | Year | |
ended 31 | ended 31 | |
December | December | |
2022 | 2021 | |
£000 | £000 | |
Cash flows from operating activities | ||
Loss before tax | (20,093) | (57,857) |
Adjustments for: | ||
Finance income | (207) | (11) |
Finance expense | - | 2 |
Lease adjustment | - | (4) |
Depreciation of property, plant and equipment | 93 | 92 |
Depreciation of right-of-use assets | - | 94 |
Amortisation of intangible fixed assets | 9 | 9 |
Share-based payment charge | 919 | 508 |
Cash flows from operations before changes in working capital | (19,279) | (57,167) |
Decrease in inventories | - | 41 |
Decrease in trade and other receivables | 289 | 7,841 |
(Decrease)/Increase in trade and other payables | (4,384) | 4,359 |
Cash used in operations | (23,374) | (44,926) |
Tax credit received | 9,088 | 3,910 |
Net cash used in operating activities | (14,286) | (41,016) |
Cash flows from investing activities | ||
Interest received | 140 | 12 |
Purchase of intangible assets | - | (18) |
Purchase of property, plant and equipment | (6) | (15) |
Increase in other financial assets | (3,750) | - |
Net cash used in investing activities | (3,616) | (21) |
Cash flows from financing activities | ||
Proceeds from issue of ordinary shares | 1 | 14 |
Principal paid on lease liabilities | - | (124) |
Interest paid on lease liabilities | - | (2) |
Net cash generated from/(used in) financing activities | 1 | (112) |
Decrease in cash and cash equivalents | (17,901) | (41,149) |
Cash and cash equivalents at beginning of the year | 33,827 | 74,976 |
Cash and cash equivalents at end of the year | 15,926 | 33,827 |
Notes
1. Basis of preparation
The financial information of the Group set out above does not constitute “statutory accounts” for the purposes of Section 435 of the Companies Act 2006. The financial information for the year ended 31 December 2022 has been extracted from the Group’s audited financial statements which were approved by the Board of directors on 26 April 2023 and will be delivered to the Registrar of Companies for England and Wales in due course. The financial information for the year ended 31 December 2021 has been extracted from the Group’s audited financial statements for that period which have been delivered to the Registrar of Companies for England and Wales. The reports of the auditors on both these financial statements were unqualified, did not include any references to any matters to which the auditors drew attention by way of emphasis without qualifying their report and did not contain a statement under Section 498(2) or Section 498(3) of the Companies Act 2006. While the financial information included in this preliminary announcement has been prepared in accordance with the recognition and measurement criteria of UK adopted International Financial Reporting Standards (‘IFRSs’), this announcement does not itself contain sufficient information to comply with those IFRSs. This financial information has been prepared in accordance with the accounting policies set out in the December 2022 report and financial statements.
2. Tax
The tax credit of £2,448,000 (2021: £9,194,000) relates to research and development tax credits in respect of the year ended 31 December 2022 (£2,415,000) and an adjustment in respect of prior periods (£33,000).
3. Loss per ordinary share
Basic loss per share is calculated by dividing the loss attributable to ordinary equity holders of the parent company by the weighted average number of ordinary shares in issue during the year.
The loss attributable to ordinary shareholders and weighted average number of ordinary shares for the purpose of calculating the diluted earnings per ordinary share are identical to those used for basic loss per share. This is because the exercise of share options would have the effect of reducing the loss per ordinary share and is therefore antidilutive under the terms of IAS 33.
[1] Synairgen on file.
[2] IQVIA market research Q4 2022; Sources: US CDC, HCUP, IQVIA Claims Data, PubMed; data on file.
[3] Hartnett J. Influenza Other Respir Viruses. 2022;16:906–915; Pastula ST et.al.,OFID, 2017, ofw270; Zhou JA et.al., CID, 2020, 70(5): 773-779; Disease Burden of Flu | CDC; Preliminary Medicare COVID-19 Data Snapshot (Dec 2021); ICER Report: Special Assessment of Outpatient Treatments for COVID-19 (Feb 2022).
[4] Synairgen on file.
[5] WHO Solidarity Trial Consortium. Repurposed Antiviral Drugs for Covid-19 — Interim WHO Solidarity Trial Results. N Engl J Med. 2021;384:497–511.