4basebio PLC
("4basebio", the "Company" or the “Group”)
Half-year Report
for the six months ended 30 June 2022
4basebio PLC (AIM: 4BB), the specialist life sciences group focused on exploiting intellectual property in the field of cell and gene therapies and DNA vaccines, announces its unaudited half-year results for the six months ended 30 June 2022.
Operational Highlights (including post period end)
-- Clean rooms for DNA manufacturing commissioned -- Commercial sale of proprietary DNA -- Strengthening IP with three further patent filings -- Development of application specific suite of proprietary DNA constructs -- Evaluation and collaboration agreements signedFinancial Highlights
-- Cash balances of £5.6 million at period end -- Cash runway into 2023 before utilisation of available debt facility -- Loss for the period of £2.4 million (H1 2021 loss: £1.7 million) -- Net cash outflow from operating activities of £2.5 million (H1 2021: £1.7 million)Commenting on the interim results, Dr Heikki Lanckriet, CEO and CSO, said “We continue to make excellent progress and are pleased to report our first DNA sales in the period. While revenues will remain modest for 2022, we have now made multiple sales and we are confident in the overall commercial prospects of both our synthetic DNA and non-viral vector technology.
“We have also now taken possession of our manufacturing suites and are working hard to implement systems and processes which will enable the manufacture of GMP DNA as early as possible in 2023. Alongside this, we continue to develop our intellectual property, with three further patents filings in July 2022.
“We are very excited to be demonstrating the flexibility of our DNA technology having developed a suite of proprietary application specific synthetic DNA constructs optimised for the AAV, mRNA, gene editing and DNA vaccine markets.
“We continue to invest in our technology platforms, with overall cash expenditure during the period as expected. Looking forward to 2023, further funding will be required. We remain open to a possible capital increase where this is at a meaningful premium to the Company’s prevailing share price; however, at this time, we expect to draw down on our available debt facilities during H1 2023.”
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
For further enquiries, please contact:
4basebio PLC +44 (0)12 2396 7943 Heikki Lanckriet, CEO and CSO Cairn Financial Advisers LLP (Nominated Adviser) +44 (0)20 7213 0880 Jo Turner / Sandy Jamieson finnCap Ltd (Broker) Geoff Nash/Richard Chambers/Charlotte Sutcliffe +44 (0)20 7220 0500Notes to Editors
4basebio (AIM: 4BB) is a specialist life sciences group focused on therapeutic DNA for cell and gene therapies and DNA vaccines and providing solutions for effective and safe delivery of these DNA based products to patients. It is the intention of the Company to become a market leader in the manufacture and supply of high purity, synthetic DNA for research, therapeutic and pharmacological use and develop non-viral vectors for the efficient delivery of payloads. The immediate objectives of 4basebio are to continue the validation of its DNA products and Hermes™ technology and commence revenue generation during 2022. 4basebio also continues to advance its collaborations to facilitate the functional validation of its DNA based products and cell and gene delivery solutions.
Chairman’s Statement
Introduction
The Board is pleased to report that 4basebio continued to make good progress in the first half of the year in validating and commercialising 4basebio DNA and targeted nanoparticle delivery technologies. Both technologies have broad application in gene and cell therapy as well as vaccines; and as reported previously, we see particular near-term opportunities in AAVs (adeno-associated viral vectors) for gene therapy and in-vitro transcription (IVT) for the production of mRNA vaccines.
During the period, as noted above, 4basebio also recorded its first DNA revenues and completed the development of its manufacturing facility comprising seven DNA production suites.
As expected, and as indicated in our 2021 Annual Report, 4basebio continued with its investment in its technologies with the result that the Group incurred a net loss for the first half of 2022.
Operational Review
4basebio continues to operate from three locations near Cambridge, UK and Madrid, Spain and has established strong R&D groups in both countries. These groups remained focussed on enhancing and scaling processes around its synthetic DNA manufacture, its targeted nanoparticle technology, as well as product and process innovation, strengthening the 4basebio’s intellectual property.
Alongside its R&D activities, the Group has scaled up its manufacturing and quality assurance teams significantly during the period. This coincides with 4basebio taking full control of its manufacturing facility near Cambridge and progressing with its operational validation. The next objective is to implement GMP processes and procedures during the second half of 2022 with a view to manufacturing first GMP batches in 2023.
In order to support both its research and manufacturing activities, the Group continues to recruit, principally in the UK, with overall headcount increasing from 33 at 31 December 2021 to 51 at 30 June 2022. It is anticipated this will grow further during the second half of the year.
The commercial development of the Group also continued apace, with first synthetic DNA revenues recorded in H1 2022. 4basebio is now working to develop a pipeline of commercial opportunities. Currently, these are typically early-stage projects where customers are evaluating 4basebio technology with their customer specific application needs. The Group expects its pipeline to grow with further DNA and nanoparticle revenues in H2 2022. Visibility on the impact on revenue and overall financial performance is however limited.
During the half year, 4basebio also announced further collaborations:
-- research collaboration with Teesside University and the University of Alabama for the treatment of Neurofibromatosis Type 1; -- joint development agreement with Heqet Therapeutics for the development of a non-viral vector therapy for cardiac regeneration; and -- strategic research collaboration with eTheRNA immunotherapies relating to the evaluation of linear DNA for mRNA production.(The Group also has further evaluation projects ongoing which are subject to non-disclosure agreements.)
In summary, during the first half of 2022 4basebio has built critical mass in its R&D and manufacturing teams as well as progressing its commercial objectives. The Directors consider the Group to be extremely well placed to continue the commercial exploitation of its DNA and nanoparticle technology.
Business outlook
Overall revenues are expected to be consistent with previous periods, reflecting some revenues from DNA and Hermes™ services, offsetting a decline in legacy revenues with certain historic one-time orders now not expected to repeat.
The Group expects to continue investing in its technologies and staff team during the remainder of 2022. The ongoing expenditure will continue to be much greater than revenues, with the Group reporting a loss for the full year. This is as previously indicated.
Financial Review
The results for the period ended 30 June 2022 and the consolidated balance sheet at that date reflect the consolidated performance and position of 4basebio PLC and all its subsidiary companies.
Revenue
Revenue in the first six months of 2022 (“H1 2022”) was £0.15 million (H1 2021: £0.18 million). This reflects a fall in legacy revenue from kit sales and licence income offset by modest sales from DNA.
Cost of sales
Cost of sales in H1 2022 was £37k (H1 2021: £38k). Cost of sales reflects a combination of amortisation on previously capitalised intangible assets linked to kit sales and inputs for DNA production.
Selling and administration expenses
Selling, general and administrative expenses were a combined £1.4 million in H1 2022 (H1 2021: £1.2 million) reflecting the underlying growth in the scale of the business.
Operations expense
Operations expense is a new expenditure line for the Group, capturing expenditure relating to manufacturing and quality assurance. Operations expense includes primarily payroll and consumables spend.
Research and development
Overall research and development expenditure for H1 2022 was £1.6 million (H1 2021: £0.86 million), of which £0.55 million was capitalised in the period (H1 2021: £0.23 million). Overall expenditure increased due to the ongoing expansion of the UK team and investment in R&D programs. Capitalised expenditure relates to platform research undertaken in Spain.
Tax
Tax represents R&D tax credits expected to be recovered in relation to expenditure during the first half of the year.
Balance sheet
Non-current assets increased to £5.5 million at 30 June 2022 from £4.1 million at 31 December 2021; this related to additions of tangible fixed assets in the UK and capitalised R&D expenditure in Spain as shown in notes 6 and 7 to the half year results. Current assets fell to £6.9 million at 30 June 2022 from £10.6 million at 31 December 2021, due primarily to cash outflows during the first half of 2022. As a result, closing cash balances at 30 June 2022 stood at £5.6 million (31 December 2021: £9.6 million).
Current liabilities increased to £1.6 million at 30 June 2022 from £1.5 million at 31 December 2021 due primarily to an increase in trade payables associated with fixed asset additions. Long term financial liabilities reduced due to reclassification of soft loans from long term to short term liabilities. As a result, overall long term liabilities stood at £1.3 million as at 30 June 2022 (31 December 2021: £1.5 million). Other long term liabilities represent deferred grant income in Spain.
Share Capital at both 30 June 2022 and 31 December 2021 reflects the capital contributions arising from the 2020 spin out process as explained in note 3.2 to the financial statements included in the Annual Report for 2021.
Cash flow
Net cash outflows from operations were £2.5 million for the period ended 30 June 2022 (period ended 30 June 2021: outflows of £1.7 million). This reflects an increase in operating cashflows directly arising from the growth in operations between the periods as presented in the profit and loss account.
Cash outflows from investing activities increased significantly with the investment in tangible fixed assets £1m for the period ended 30 June 2022 (period ended 30 June 2021: £0.1 million) relating to both the manufacturing facility and expansion of R&D laboratories. In addition, capitalised development expenditure in 4basebio S.L.U. increased to £0.4 million from £0.2 million in period ended 30 June 2021.
Cashflows from financing for the period ended 30 June 2022 were relatively flat against the previous period, with the change dictated by the level of Spanish soft loan repayments.
Exchange differences for the period represent changes in the British pound value of cash balances held in foreign currency, almost entirely euro denominated.
Tim McCarthy
Chairman
29 September 2022
Consolidated statement of profit or loss and other comprehensive income
for the six months ended 30 June 2022
All of the loss for each period is from continuing operations.
Consolidated statement of financial position
30 June 2022
Consolidated statement of changes in equity
for the six months ended 30 June 2022
Consolidated statement of cash flows
for the six months ended 30 June 2022
Notes to the financial statements
For the six months ended 30 June 2022
1.General information
4basebio PLC is registered in England and Wales as a public limited company since 20 July 2021. Prior to that date it was registered as a United Kingdom Societas under the name 4basebio UK Societas. The conversion to a public limited company occurred following shareholder approval of the conversion at its Annual General Meeting held on 30 June 2021. With the conversion, the name of the Company changed to 4basebio PLC.
The Company is domiciled in England and the registered office of the Company is 25 Norman Way, Over, Cambridge, CB24 5QE. 4basebio PLC is the parent of a group of companies. The group structure remains the same as that shown in the Company’s financial statements for the year ended 31 December 2021. The Group focusses on life sciences and in particular the development of synthetic DNA and nanoparticles suitable for inclusion in, or delivery of, therapeutic payloads for cell or gene therapies and gene vaccines.
The interim report was approved by the board of directors on 29 September 2022.
The Company’s shares are traded on London Stock Exchange’s AIM market, having been admitted on 17 February 2021. The international securities number (ISIN) number for its AIM traded shares is GB00BLD8ZL39; its ticker symbol is 4bb.l.
2.Significant accounting policies
Basis of preparation
This half year report, which is not audited, has been prepared in accordance with the measurement and recognition criteria of UK adopted International Accounting Standards. It does not include all the information required for full annual financial statements and should be read in conjunction with the financial statements of the Company and its subsidiaries (the “Group”) for the year ended 31 December 2021.
The accounting policies applied in this half year report are consistent with those in the financial statements for the year ended 31 December 2021, as described in those financial statements.
Significant judgments
In the application of the Group’s accounting policies, management is required to make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The significant judgments made in relation to the financial statements are further set out below.
Going concern
The directors have, at the time of approving the half year report, a reasonable expectation that the Group has adequate resources to continue in operational existence for the foreseeable future. Thus, they continue to adopt the going concern basis of accounting in preparing the financial statements.
Internally?generated intangible assets – research and development expenditure
Development expenditure is capitalised when the conditions referred to in Note 3.2 of the Company's 2021 annual report are met. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognised in the period in which the estimate is revised if the revision affects only that period or in the period of the revision and future periods if the revision affects both current and future periods.
3.Foreign currencies
The functional currency of the Group is British Pounds.
The principal currency rate of the Group other than the British Pounds is the euro which has developed as follows in relation to the equivalent of one pound (GBP/£):
[in GBP] Closing exchange rate Average exchange rate 30 June 2022 31 December Six months Six months Year ended 31 2021 ended 30 June ended 30 June December 2021 2022 2021 Euro 0.8582 0.8403 0.8424 0.8678 0.85944.Income taxes
The Group anticipates claiming R&D tax credits in both the UK and Spain in relation to the year ended 31 December 2022 and 2021. The quantum of such claims for the first half of 2022 is estimated at £0.3 million (period ending 30 June 2021: £0.2 million).
5.Loss per share
Six months ended 30 Six months ended 30 Year ended 31 June 2022 June 2021 December 2021 Numerator [in £‘000] Loss for the period (2,430) (1,650) (3,235) Denominator [number of shares] Weighted average number of registered 12,317,473 12,317,473 12,317,473 shares in circulation (ordinary shares) for calculating the undiluted earnings per share Diluted and Undiluted (0.20) (0.13) (0.26) earnings per share (£/share)6.Intangible assets
[in £‘000] Development costs Licences Total Cost or acquisition value 01 January 2021 1,987 128 2,115 Additions 545 83 628 Exchange differences (142) (11) (153) 31 December 2021 2,390 200 2,590 01 January 2022 2,390 200 2,590 Additions 331 72 403 Exchange differences 56 6 62 30 June 2022 2,777 278 3,055 Cumulative amortisation and impairment 01 January 2021 1,304 26 1,330 Amortisation 69 9 78 Exchange differences (87) (2) (89) 31 December 2021 1,286 33 1,319 01 January 2022 1,286 33 1,319 Amortisation 7 6 13 Exchange differences 27 1 28 30 June 2022 1,320 40 1,360 Net book value 31 December 2021 1,104 167 1,271 30 June 2022 1,457 238 1,6957.Property, plant and equipment
[in £‘000] Operating Land and buildings Right of use Assets under Total equipment assets construction Cost or acquisition value 01 January 2021 598 997 166 1,761 Additions 308 - 478 751 1,537 Transfers - - - - - Exchange (24) - (9) - (33) differences 31 December 2021 882 997 635 751 3,265 01 January 2022 882 997 635 751 3,265 Additions 909 43 - - 952 Transfers 751 - - (751) - Exchange 7 1 3 - 11 differences 30 June 2022 2,549 1,041 638 - 4,228 Cumulative amortisation and impairment 01 January 2021 249 5 29 - 283 Depreciation 124 46 72 - 242 Exchange (16) - (3) - (19) differences 31 December 2021 357 51 98 - 506 01 January 2022 357 51 98 - 506 Depreciation 115 67 43 - 225 Exchange 5 1 3 - 9 differences 30 June 2022 477 119 144 - 740 Net book value 31 December 2021 525 946 537 751 2,759 30 June 2022 2,072 922 494 - 3,4888.Cash and cash equivalents
[in £‘000] 30 June 2022 31 December 2021 Bank balances and cash in hand 5,597 9,586 Cash and cash equivalents 5,597 9,5869.Equity
The share capital of 4basebio PLC as of 30 June 2022 and 31 December 2021 amounts to a total of €12,317,473 divided into 12,317,473 shares of €1. These are all registered ordinary shares. There are no shares with special rights or other restrictions on voting rights.
Share-based payments
During H1 2022, 53,000 share options to subscribe for shares in the Company were granted to employees with an average weighted exercise price of £5.59 per share. The share options awarded vest one quarter on the anniversary of grant, over four years. Consistent with previous awards as explained in note 25 to the 2021 financial statements, the awards were valued using a Black Scholes valuation model.
An overall share-based payments charge of £51,000 has been expensed in the period with a corresponding amount recognised in equity based on fair values of between £0.22 and £2.36 per option, as at the dates of grant.
10.Approval of the half year report
The half year report was approved by the board of directors and authorised for publication on 29 September 2022.
Forward-looking statements
This announcement may contain certain statements about the future outlook for the 4basebio. Although the directors believe their expectations are based on reasonable assumptions, any statements about future outlook may be influenced by factors that could cause actual outcomes and results to be materially different.
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