REG - Theracryf PLC - Half-year Report
28/11/2024 07:00
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RNS Number : 9118N Theracryf PLC 28 November 2024
TheraCryf plc
("TheraCryf" or "the Company" or "the Group")
Half Year Report to 30 September 2024
Alderley Park, UK 28 November 2024. TheraCryf plc (AIM: TCF), the clinical
stage drug development company focusing on oncology and neuropsychiatry,
announces its unaudited interim results for the six months ended 30 September
2024.
Operational highlights
· Acquisition of Chronos Therapeutics Ltd (Chronos) in April 2024 added a
late pre-clinical stage neuropsychiatry portfolio - integration now complete,
Chronos is now a wholly owned subsidiary
· Placing, Subscription and Retail Offer in April 2024 raised gross
proceeds of £0.9m, with directors and PDMRs investing c.10% of gross proceeds
· R&D Day in June 2024 presented extensive data on SFX-01 in models
of glioblastoma (GBM) by colleagues from Erasmus Medical Centre, Rotterdam
showing effectiveness of SFX-01 in these models, the third such observation in
different academic centres
o Presentations also included data on acquired Chronos assets - DAT, an
atypical dopamine reuptake inhibitor with potential utility in fatigue and
narcolepsy; and OX-1, an orexin-1 receptor antagonist with potential utility
in addiction and anxiety disorders
· Publication of full paper on effectiveness of SFX-01 in models of
childhood cancer rhabdomyosarcoma by collaborators at University La Sapienza,
Rome in peer-reviewed journal BMC Cancer, confirming effects of SFX-01 as a
radiosensitising agent as seen in models of glioblastoma
Post period
· Sudden passing of Chair of the Board and highly respected biotech
executive, Dr Sue Foden, in November 2024
· Publication of full paper on SFX-01 Phase 1b healthy volunteer PK
study published in peer reviewed journal Advances in Therapy in November 2024
· Amicable discussions continue with partner Stalicla SA on optimal
design of the Phase 2 study in autism spectrum disorder and ongoing dispute
· European Patent Office decision to grant composition of matter patent
for acquired Ox-1 antagonist in Europe - formal grant to be made on 18
December 2024
Financial highlights
· Financial performance in line with expectations:
o Post-tax loss of £1.1m (2023: £1.5m)
o Cash outflow from operations of £1.1m (2023: £1.3m)
o Cash deposits, cash and cash equivalents balance on 30 September 2024 of
£1.2m (30 September 2023: £3.7m)
· Cash runway unchanged to end of 2025 excluding any potential
milestone payments.
Dr Huw Jones, Chief Executive Officer of TheraCryf, said:
"The first half of the year saw a transformation of the Company with the
integration of the acquired Chronos assets, thus tripling the size of our
R&D portfolio and expanding the potential opportunities for substantial
monetisation. Planning for the atypical dopamine uptake inhibitor (DAT) and
Orexin-1 antagonist programmes has also started in earnest.
"We saw further data generated on lead asset SFX-01 by collaborators on our
grant funded GBM programme from the Erasmus MC in Rotterdam - triangulating
data published by two other collaborators and further de-risking the
programme, showing different cell lines and tissues all responding to SFX-01
in independent laboratories with varying methodologies. Data demonstrating
SFX-01's effectiveness in radiosensitisation in rhabdomyosarcoma was also
published in a prestigious cancer journal by our collaborators from University
La Sapienza, Rome.
"Post period, data from our Phase 1b healthy volunteer PK study of SFX-01 was
published in peer reviewed journal Advances in Therapy, showing the
effectiveness of our new enteric coated tablet formation in proceeding beyond
the acid environment of the stomach and releasing active drug where desired,
in the small intestine. Concentrations of sulforaphane and metabolites were
observed in the range where biological activity is seen in models of various
diseases of interest."
"Recently we have had a notification from the European Patent Office of an
intention to grant a composition of matter patent for our acquired OX-1
antagonist asset in December 2024. This complements patents already granted in
territories such as the USA."
"In November, we were shocked and saddened at the sudden and unexpected death
of our Chair Dr Sue Foden. Sue was highly supportive of management in the
development and delivery of our plans and I re-iterate our deepest sympathies
to her family and friends."
"Despite the recent sad news, we are better positioned than ever to execute on
our business model to generate compelling data sets and commercialise our
assets via accretive industry collaborations."
Dr Huw Jones, CEO, and Toni Hänninen, CFO will provide a live results
presentation via the Investor Meet Company platform at 11am GMT on Thursday,
28 November 2024.
The presentation is open to all existing and potential shareholders and can be
accessed via https://www.investormeetcompany.com/
Enquiries:
TheraCryf PLC +44 1625 466591
Dr Huw Jones, CEO
Toni Hänninen, CFO
Cavendish Capital Markets (Nominated Advisor and Broker) +44 20 7220 0500
Geoff Nash / Teddy Whiley / Rory Sale (Corporate Finance)
Nigel Birks/Harriet Ward (ECM)
Vigo Consulting +44 (0)20 7390 0231
Rozi Morris
theracryf@vigoconsulting.com
Notes to Editors
About TheraCryf plc
TheraCryf is the clinical stage drug development company focussing on oncology
and neuropsychiatry. The Company has a broad clinical and preclinical pipeline
in indications including glioblastoma* neurodevelopmental disorders,
addiction, anxiety and narcolepsy [*orphan indication].
The Company's strategy is to generate compelling data sets to preclinical
and/or clinical proof of concept and partner its clinical programmes with
mid-size to large pharma for larger trials and commercialisation. As well as a
number of industry partnerships with companies, including Stalicla SA, in
neurodevelopmental disorders. The Company has sourced know how for
programmes from companies such as Shire (now Takeda) via the recent
acquisition.
TheraCryf has worked with and has ongoing collaborations with major
universities and hospitals such as the University of Manchester, La Sapienza
(Università di Roma), the Erasmus Medical Centre, Rotterdam, Kings College
London and the University of Michigan.
The Company has its headquarters and registered office at Alderley
Park, Cheshire. It is quoted on AIM in London and trades under the
ticker symbol TCF.
For further information, please visit: www.theracryf.com
(http://www.theracryf.com/)
OPERATIONAL UPDATE
PIPELINE
During the first half of the year, TheraCryf has been delivering on
challenging objectives with the backdrop of a difficult market for listed
biotech companies. The Company's pipeline has tripled in size and with that,
the opportunities for monetisation by delivering on its business model have
increased proportionately.
In April 2024 the Company acquired the entire issued share capital of Chronos
for a total combined consideration of £968k payable in cash (£78k) and
Ordinary Shares (£890k) at a price of 1.44 pence per Ordinary Share,
potentially increasing up to a total of c.£3.4 million subject to the
achievement of certain milestones (the "Acquisition") (see note 5). A Placing
and Subscription raised £0.85 million (before expenses) and a
further £0.05 million via a Retail Offer, resulting in gross proceeds of
£0.9m. Over 10% of the proceeds were via participation by the Company's
Directors and PDMRs.
Chronos became a wholly owned subsidiary of the Company at that time. The
acquired programmes comprise two late pre-clinical stage assets; an orexin-1
receptor antagonist (Ox-1) targeting addition, impulsivity and anxiety and an
atypical dopamine transporter inhibitor (DAT) targeting fatigue and
narcolepsy. These neuropsychiatric indications are in a resurgent area for
large pharmaceutical companies with two multi-billion dollar acquisitions of
clinical stage companies being announced in December 2023.
The acquisition increases the Company's research and development portfolio by
a factor of three, increasing opportunities to deliver on the business model
of creating compelling pre-clinical and/or clinical data sets then monetising
assets by out licensing to large companies thus enhancing shareholder value.
The diversity of the pipeline has broadened significantly also, adding two
additional programmes in new areas of high unmet medical need and potential
partner interest to the GBM programme on lead clinical asset SFX-01.
Reflecting this broader mission, Evgen Pharma plc was renamed TheraCryf plc
and the ticker symbol changed to TCF.L effective on 26 April 2024. The name,
TheraCryf, is a blend of the Greek for treating medically 'Thera' and the
Welsh for strong, 'Cryf', to reflect the aims of the Company to develop a new
generation of innovative therapeutics in attractive segments within oncology
and neuropsychiatry.
Looking forward, the Company is focussed on preparing SFX-01 for the grant
funded clinical study in GBM patients, to continuing to work amicably with its
partner Stalicla and to unlock the value of its new programmes via the
acquisition of Chronos whilst remaining true to its strategy of capital
efficient drug development.
CLINICAL STAGE PROGRAMMES
Glioblastoma, GBM
GBM, the most severe form of the primary brain cancer glioma has an incidence
of 3.8 per 100,000 people. Prognosis with this severe form is poor with median
survival of approximately 14 months and five-year survival of around 5% of
diagnosed patients. With treatment options being limited to surgery followed
by radiotherapy and only one drug approved for the condition, there is a very
high need for novel treatments.
SFX-01 has already been awarded orphan drug status in this indication by the
US FDA and regulatory scientific advice received subsequently from the Dutch
Medicines Evaluation Board confirming there are no specific concerns regarding
the clinical safety profile of SFX-01.
During the period, collaborator Dr Marjolein Geurts, neuro-oncologist at the
Erasmus Medical Centre Rotterdam, NL continued to lead the SFX-01 GBM
pre-clinical and clinical grant from the Netherlands government administered
by the Dutch cancer society, KWF for a €1.1m total project value. As
presented during the June R&D day, in vitro experiments from tumour
tissue donated by patients at Dr Geurts' clinic showed SFX-01 to be active in
these samples, corroborating prior published work from collaborators in
Abruzzo, Italy and Auckland, New Zealand. The Company is working closely
with Dr Geurts' group on the project providing expertise, research quality
SFX-01 and eventually SFX-01 enteric-coated tablets for use in the clinical
study. The clinical study is expected to commence in early 2026 following
completion of the laboratory experiments and approval from European regulatory
authorities for conduct of the study. The window of opportunity study aims to
confirm that sulforaphane and/or metabolites from SFX-01 enters the tumour
tissue in patients and also to assess interactions of sulphoraphane with
molecular targets in excised tumour tissue.
Phase1/1b Human Volunteer Study
A Phase 1/1b study in healthy volunteers of the novel SFX-01 enteric-coated
tablet formulation was completed in 2023. The trial comprised three cohorts of
eight volunteers each, of which two in each cohort received a matching
placebo. The trial was randomised and double-blinded.
The full clinical study report (CSR) was completed for the PK data from the
study for future submission to regulatory authorities. The report confirmed
that the PK data showed absorption of sulforaphane at a time scale consistent
with the objective for the new formulation. Results showed release in the
small intestine and protection by the enteric coat on the tablet and the
reliable conversion in the body to active metabolites. The total sulforaphane
and active metabolite levels were found at concentrations that, in the test
tube, are responsible for biological activity. There were no serious adverse
events reported. During the period, the Company submitted the study for
publication in a reputable, peer reviewed research journal. (See Post Period
Events).
PRE-CLINICAL PROGRAMMES
TheraCryf continues to support academic research to broaden the potential
range of applications for SFX-01 and increase mechanistic understanding in
various disease areas of high unmet medical need.
Erasmus Medical Centre (MC) Rotterdam, Netherlands
As described in the clinical section above, and as presented at the R&D
day, experiments conducted at the Erasmus MC using tissue from GBM tumours
have shown biological activity of SFX-01. This work continues as a precursor
to proceeding to a clinical trial in the same centre.
Università Sapienza di Roma, Italy
Based on previous findings from pre-clinical work in glioma, the Company
worked with Prof. Francesco Marampon, of Università Sapienza di Roma to
investigate the hypothesis that SFX-01 could enhance the action of
radiotherapy in cancer patients. The scientific work evaluated the anti-tumour
activity of SFX-01 in two preclinical cellular models of rhabdomyosarcoma
(RMS) tumours, the most frequent soft tissue sarcoma in childhood. This
disease is mostly diagnosed in children under 10 years old.
The in vitro data showed that SFX-01 reduced tumour cell growth by
inducing G2 cell cycle arrest and triggering early-apoptosis (cell
death). In addition, SFX-01 was shown to be effective both as a single agent
and in combination with radiotherapy where it was found to be synergistic; it
created a more positive outcome than would be expected by simply adding the
two agents together. The results also showed that SFX-01 was able to reduce
tumour cell growth in clinically relevant radioresistant RMS cells,
substantially inhibiting the formation of cancer stem cell-derived
tumourspheres (rabdospheres).
The experiments were then extended to in vivo mouse models whereby
rhabdomyosarcoma cells are implanted into the animals allowing treatment
effects to be evaluated in life, in a more disease relevant condition. SFX-01
was shown to be effective in these models after oral administration
complementing the earlier in vitro results. SFX-01 was also given in
combination with a radiotherapy regime where it was shown to act
synergistically, resulting in a more positive outcome than would be expected
by simply adding the two agents together. A full paper on effectiveness of
SFX-01 in models of this, the most common childhood cancer in under 10's, was
published in the prestigious journal BMC Cancer,
[https://bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12536-8] in
July 2024, confirming effects of SFX-01 as a radiosensitising agent as seen in
models of glioblastoma.
OUTLICENSING
STALICLA partnership
In October 2022, the Company licensed the global rights for lead asset SFX-01
in neurodevelopmental disorders and schizophrenia to STALICLA SA (Stalicla),
a Swiss company specialising in the identification of specific phenotypes of
ASD, using its proprietary precision medicine platform. The Company retains
the global rights for all other indications.
The financial terms included a signing fee of $0.5m to acquire the license
and $0.5m on completion of the human volunteer Phase 1/1b study; TheraCryf
would provide data to support Stalicla's clinical trials and both would
contribute to the costs of supplying SFX-01 and placebo for these trials.
Thereafter, milestone payments that reflect progress by Stalicla in their
development programme up to commercial launch amount to $26.5m,
including $5m on grant of IND by the FDA (originally anticipated by the end
of 2024). Total milestones of up to $160.5m are payable. Royalties
payable to TheraCryf on sales are in the low to medium double-digit range in
all scenarios, including on-licensing by Stalicla and use of SFX-01 in further
licensed indications.
Previous studies with other sources of sulforaphane have shown evidence of
clinical efficacy in improving symptoms of ASD (e.g., Singh et al 2014).
However, patient heterogeneity provides a challenge in identifying those
individuals likely to respond to therapy. Stalicla has a unique, proprietary
technology to identify ASD patients who are most likely to respond to SFX-01.
This screening approach has already been used successfully to identify ideal
patients for other ASD drug trials and is a key differentiator for Stalicla in
developing drugs for such a wide spectrum disorder as ASD.
In February 2024 TheraCryf gave a notice of dispute to Stalicla.
The TheraCryf board of directors believes that the Company has met the terms
required to satisfy the $0.5m milestone, according to the License Agreement,
and thus the payment is due. In order to effect the payment, the Company has
taken the decision to formally implement the dispute resolution process
detailed in the License Agreement, the first step of which is the issuance of
a dispute notice.
As stated previously the Company has not included any milestone payments from
Stalicla in its financial forecasting and the cash runway remains unchanged.
The Company continues to discuss amicably a route to resolve the current
dispute with Stalicla management and will provide updates once these
discussions conclude.
POST PERIOD EVENTS
Post period, the Phase 1 healthy volunteer study on the new enteric coated
SFX-01 tablet was published in the peer reviewed journal Advances in Therapy
[https://link.springer.com/article/10.1007/s12325-024-03018-1] demonstrating
the effectiveness of the enteric coat in proceeding beyond the acid
environment of the stomach and releasing active drug where desired, in the
small intestine. SFX-01 was well tolerated by the healthy volunteers and there
were no serious adverse events of any sort. Concentrations of sulforaphane and
metabolites in volunteers' blood were observed in the range where biological
activity is seen in models of various diseases of interest including in vitro
and in vivo models of GBM.
FINANCIAL REVIEW
The financial performance for the six-month period to 30 September 2024 was in
line with expectations. Operating losses reduced in the period by £0.35m to
£1.11m compared with £1.46m in the prior period. Use of cash reflects the
completion and publication of the SFX-01 Phase 1b healthy volunteer clinical
trial plus continued SFX-01 manufacturing process development and product
manufacture to support the grant funded clinical trial to be conducted by
Erasmus MC, Rotterdam, NL in early 2026. Costs of the acquisition and
integration of Chronos were modest and are also included in use of cash.
Consequently, the total comprehensive loss for the period was £1.11m (30
September 2023: £1.46m).
The net cash outflow for the period was £0.81m (2023: £1.27m); the similar
comparison with the prior period reflects working capital movements and the
receipt of the R&D credit of £nil (respective £0.91m in FY 2023). In
2023 the R&D tax credit of £0.91m was received during the period, however
in 2024 the Company expects the receipt of £0.39m during Q4 2024.
The total cash position (including cash deposits, short term investments and
cash equivalents) as at 30 September 2024 was £1.20m (30 September 2023:
£3.73m).
The Directors estimate that the cash held by the Group will be sufficient to
support the current level of activities to the end of 2025. They have
therefore prepared the financial statements on a going concern basis.
OUTLOOK
In the last six months the Company has completed a transformative and largely
share-based acquisition which broadens the pipeline considerably in both
number of research programmes and variety of disease targets. In turn, the
opportunities for generating long-term value have increased proportionally.
Active searches for non-dilutive funding of the new programmes are underway
and the Company will provide updates as these come to fruition.
The SFX-01 grant funded programme in glioblastoma at the Erasmus Cancer
Center, Rotterdam continues apace with progression to in vivo rodent models
shortly and in 2026 dosing of first GBM patients.
The Company's cash position remains healthy, especially in comparison to
European peers with a runway to the end of 2025, allowing headroom to continue
to progress the multiple opportunities for the expanded pipeline.
The Board would like to thank all shareholders for their support and look
forward to progressing the Company's strategy which remains focused on
commercializing the potential of its expanded pipeline.
Dr Alan Barge
Dr Huw Jones
Senior Independent Non-executive
Director
CEO
28 November 2024
Consolidated Statement of Comprehensive Income
for the six months ended 30 September 2024 - unaudited
Six months ended Six months ended Year
30 September 2024 30 September 2023 ended
31 March 2024
£'000 £'000 £'000
Notes Unaudited Unaudited Audited
Revenue - 396 396
Operating expenses
Operating expenses (1,229) (1,802) (3,825)
Share based compensation 4 (21) (53) (137)
Total operating expenses (1,250) (1,855) (3,962)
Operating loss (1,250) (1,459) (3,566)
Finance income 5 - -
Loss on ordinary activities before taxation (1,245) (1,459) (3,566)
Taxation - - 429
Loss and total comprehensive expense attributable to equity holders of the (1,245) (1,459) (3,137)
parent for the period
Loss per share attributable to equity holders of the parent (pence)
Basic loss per share 3 (0.29) (0.53) (1.14)
Diluted loss per share 3 (0.29) (0.53) (1.14)
Consolidated Statement of Financial Position
as at 30 September 2024 - unaudited
As at As at As at
30 September 2024 30 September 2023 31 March 2024
£'000 £'000 £'000
Notes Unaudited Unaudited Audited
ASSETS
Non-current assets
Property, plant and equipment - 1 -
Intangible assets 1,097 39 34
Total non-current assets 1,097 40 34
Current assets
Trade and other receivables 408 582 595
Current tax receivable 429 - 429
Short-term investments and cash on deposit 5 - -
Cash and cash equivalents 1,196 3,728 2,004
Total current assets 2,038 4,310 3,028
Total assets 3,135 4,350 3,062
LIABILITIES AND EQUITY
Current liabilities
Trade and other payables 467 415 722
Total current liabilities 467 415 722
Equity
Ordinary shares 5 1,068 687 687
Share premium 29,040 27,870 27,870
Merger reserve 2,067 2,067 2,067
Share based compensation 222 562 635
Retained deficit (29,729) (27,251) (28,918)
Total equity attributable to equity holders of the parent 2,668 3,935 2,341
Total liabilities and equity 3,135 4,350 3,062
The registered number of TheraCryf plc is 09246681.
Consolidated Statement of Changes in Equity
for the six months ended 30 September 2024 - unaudited
Ordinary Share Merger Share based Retained
shares premium reserve compensation Deficit Total
£'000 £'000 £'000 £'000 £'000 £'000
Balance at 1 April 2024 687 27,870 2,067 635 (28,918) 2,341
Total comprehensive expense for the period - - - - (1,245) (1,245)
Transactions with owners
Share issue - cash 225 676 - - - 901
Share issue - cost - (240) - - - (240)
Share issue - acquisition 156 734 - - - 890
Share based compensation - lapsed options - - - (434) 434 -
Share based compensation - share options - - - 21 - 21
Total transactions with owners 381 1,170 - (413) 434 1,572
Balance at 30 September 2024 1,068 29,040 2,067 222 (29,729) 2,668
Ordinary Share Merger Share based Retained
shares premium reserve compensation Deficit Total
£'000 £'000 £'000 £'000 £'000 £'000
Balance at 1 April 2023 687 27,870 2,067 509 (25,792) 5,341
Total comprehensive expense for the period - - - - (1,459) (1,459)
Transactions with owners
Share based compensation - share options - - - 53 - 53
Total transactions with owners - - - 53 - 53
Balance at 30 September 2023 687 27,870 2,067 562 (27,251) 3,935
Ordinary Share Merger Share based Retained
shares premium reserve compensation Deficit Total
£'000 £'000 £'000 £'000 £'000 £'000
Balance at 1 April 2023 687 27,870 2,067 509 (25,792) 5,341
Total comprehensive expense for the period - - - - (3,137) (3,137)
Transactions with owners
Share issue - lapsed options - - - (11) 11 -
Share based compensation - share options - - - 137 - 137
Total transactions with owners - - - 126 11 137
Balance at 31 March 2024 687 27,870 2,067 635 (28,918) 2,341
Consolidated Statement of Cash Flows
for the six months ended 30 September 2024 - unaudited
Six months ended Six months ended
30 September 2024 30 September 2023 Year ended 31 March 2024
£'000 £'000 £'000
Unaudited Unaudited Audited
Cash flows from operating activities
Loss before taxation for the period (1,245) (1,459) (3,566)
Depreciation and amortisation 35 6 12
Share based compensation 21 53 137
(1,189) (1,400) (3,417)
Changes in working capital
Increase in trade and other receivables 208 (367) (379)
(Decrease)/increase in trade and other payables (406) (418) (113)
Cash used in operations (198) (785) (492)
Taxation received - 913 913
Net cash used in operating activities (1,387) (1,272) (2,996)
Cash flows (used in)/generated from investing activities
Interest income (5) - -
Acquisition of subsidiary (78)
Net cash (used in)/generated from investing activities (83) - -
Cash flows from financing activities
Gross proceeds from issue of shares 901 - -
Issue Costs (240)
Net cash generated from financing activities 661 - -
Movements in cash and cash equivalents in the period (808) (1,272) (2,996)
Cash and cash equivalents at start of period 2,004 5,000 5,000
Cash and cash equivalents at end of period 1,196 3,728 2,004
1. GENERAL INFORMATION
THERACRYF PLC ("TheraCryf", "the Group" or "the Company") is a public limited
company incorporated in England & Wales whose shares are traded on the AIM
market of the London Stock Exchange under the symbol TCF.
The address of its registered office is Alderley Park, Congleton Road, Nether
Alderley, SK10 4TG. The principal activity of the Group is clinical stage drug
development.
2. BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES
Basis of preparation
The Group's half-yearly financial information, which is unaudited,
consolidates the results of TheraCryf plc and its subsidiaries undertaking up
to 30 September 2024. The Group's accounting reference date is 31 March.
TheraCryf plc's shares are quoted on the AIM Market of the London Stock
Exchange.
The Company is a public limited liability company incorporated and domiciled
in the UK. The consolidated financial information is presented in round
thousands of Pounds Sterling (£'000).
The financial information contained in this half-yearly financial report does
not constitute statutory accounts as defined in section 435 of the Companies
Act 2006. It does not therefore include all of the information and disclosures
required in the annual financial statements. The financial information for the
six months ended 30 September 2023 and 30 September 2024 is unaudited.
Full audited financial statements of the Group in respect of the period ended
31 March 2024, which received an unqualified audit opinion and did not contain
a statement under section 498(2) or (3) of the Companies Act 2006, have been
delivered to the Registrar of Companies.
The accounting policies used in the preparation of the financial information
for the six months ended 30 September 2024 are in accordance with the
recognition and measurement criteria of UK-adopted International Accounting
Standards and are consistent with those which will be adopted in the annual
financial statements for the year ending 31 March 2025.
Whilst the financial information included has been prepared in accordance with
the recognition and measurement criteria of international accounting
standards, the financial information does not contain sufficient information
to comply with international accounting standards.
The Group has not applied IAS 34, Interim Financial Reporting, which is not
mandatory for UK AIM listed Groups, in the preparation of this interim
financial report.
Going concern
At 30 September 2024, the Group had cash and cash equivalents of £1.20
million.
The Directors have prepared detailed financial forecasts and cash flows
looking beyond 12 months from the date of the approval of these financial
statements. In developing these forecasts, the Directors have made assumptions
based upon their view of the current and future economic conditions that will
prevail over the forecast period.
The Directors estimate that the cash and cash equivalents held by the Group
together with known receivables will be sufficient to support the current
level of activities into the end of calendar year 2025. They have therefore
prepared the financial statements on a going concern basis.
Significant management judgement in applying accounting policies and
estimation uncertainty
When preparing the condensed consolidated interim financial information, the
Directors make a number of judgements, estimates and assumptions about the
recognition and measurement of assets, liabilities, income and expenses.
The following are significant management judgements and estimates in applying
the accounting policies of the Group that have the most significant effect on
the condensed consolidated interim financial information. Actual results may
be substantially different.
Share-based payments
The Group measures the cost of equity-settled transactions with employees by
reference to the fair value of the equity instruments at the date at which
they are granted. The fair value of the options granted is determined using
the Black Scholes model, taking into consideration the best estimate of the
expected life of the options and the estimated number of shares that will
eventually vest.
Research and development expenditure
All research and development costs, whether funded by third parties under
license and development agreements or not, are included within operating
expenses and classified as such. Research and development costs relating to
clinical trials are recognised over the period of the clinical trial based on
information provided by clinical research organisations. All other expenditure
on research and development is recognised as the work is completed.
All ongoing development expenditure is currently expensed in the period in
which it is incurred. Due to the regulatory and other uncertainties inherent
in the development of the Group's programmes, the criteria for development
costs to be recognised as an asset, as prescribed by IAS 38, 'Intangible
assets', are not met until the product has been submitted for regulatory
approval, such approval has been received and it is probable that future
economic benefits will flow to the Group. The Group does not currently have
any such internal development costs that qualify for capitalisation as
intangible assets.
3. LOSS PER SHARE
Basic loss per share is calculated by dividing the loss for the period
attributable to equity holders by the weighted average number of ordinary
shares outstanding during the period.
For diluted loss per share, the loss for the period attributable to equity
holders and the weighted average number of ordinary shares outstanding during
the period is adjusted to assume conversion of all dilutive potential ordinary
shares. As the effect of the share options would be to reduce the loss per
share, the diluted loss per share is the same as the basic loss per share.
The calculation of the Group's basic and diluted loss per share is based on
the following data:
Six months ended Six months ended Year ended
30 September 2024 30 September 2023 31 March 2024
£'000 £'000 £'000
Unaudited Unaudited Audited
Loss for the period attributable to equity holders (1,245) (1,459) (3,137)
As at As at As at
30 September 2024 30 September 2023 31 March 2024
Number Number Number
Unaudited Unaudited Audited
Weighted average number of ordinary shares 424,014,463 274,888,117 274,888,117
Effects of dilution:
Share options - - -
Weighted average number of ordinary shares adjusted for the effects of 424,014,463 274,888,117 274,888,117
dilution
Pence Pence Pence
Loss per share - basic and diluted (0.29) (0.53) (1.14)
4. SHARE-BASED PAYMENTS
As at the end of the period, the reconciliation of share option scheme
movements is as follows:
As at 30 September 2024
Number WAEP
Outstanding at 1 April 2024 14,574,910 0.0568
Granted during the period 28,731,578 0.0070
Exercised during the period - -
Lapsed/cancelled during the period (13,683,995) 0.0685
Outstanding at 30 September 2024 29,622,493 0.0114
WAEP is an abbreviation for weighted average exercise price.
During the six-month period ended 30 September 2024, a share-based payment
charge of £21,092 (six months to 30 September 2023: £52,627) was expensed to
the consolidated Statement of Comprehensive Income.
The fair values of the options granted have been calculated using a
Black-Scholes model.
5. ISSUED CAPITAL AND RESERVES
Ordinary shares
Company
Share Capital
Number £'000
As at 31 March 2024 274,888,117 687
Issued on acquisition 62,291,778 156
Issued under placing agreement 90,167,000 225
At 30 September 2024 427,346,895 1,068
New shares were issued during six-month period ended 30 September 2024 in
relation to a placing agreement and an acquisition. (see note 6)
6. ACQUISITION
On 05 April 2024, the Group acquired the entire share capital of Chronos
Therapeutics Limited via a combination of equity and cash for a total combined
consideration of £968k, which is deemed to be the provisional fair value of
the consideration subject to an assessment of the fair value of contingent
consideration. The fair values attributable to the assets and liabilities
acquired are provisional. The acquisition accounting will be finalised as part
of the FY25 Annual Report as the relevant information was not available at the
date of this report.
Chronos Therapeutics Limited
Provisional Fair Values
(Unaudited)
£'000
Intangible assets 504.16
Cash and cash equivalents 9.12
Trade and other receivables 11.77
Trade and other payables (149.76)
Net assets acquired 375.29
Cash consideration 78.40
Shares consideration 889.48
Total consideration cash and shares 967.88
Balance to Goodwill 592.59
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