REG - Theracryf PLC - Final Results - Correction
28/05/2024 16:15
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RNS Number : 1456Q Theracryf PLC 28 May 2024
This announcement replaces the Final Results announcement released at 07:00 on
28 May 2024 and includes a correction to the cash outflow bullet in the
financial highlights. The line should read: Cash outflow from operations of
£3.4m (2023: outflow of £4.9m).
TheraCryf plc
("TheraCryf", the "Company" or the "Group")
Final Results for year to 31 March 2024
Alderley Park, 28 May 2024 - TheraCryf plc (AIM: TCF), formerly Evgen Pharma
plc, the clinical stage drug development company focussing on oncology and
neuropsychiatry, announces its audited results to 31 March 2024.
Operational Update
· Grant awarded by the Netherlands government administered by the
Dutch Cancer Society for pre-clinical work and a clinical trial in
glioblastoma (GBM) led by Dr Marjolein Geurts, Erasmus MC, Rotterdam, €1.1m
project
o Activity of SFX-01 in GBM cells from Netherlands' patients corroborating
previous data from academic partners in Italy and New Zealand
· Full clinical study report issued for the SFX-01 Phase 1b study
confirming PK profile and absence of SAEs for commercial grade formulation
· Evidence of activity of SFX-01 observed in models of colon cancer
(University of Michigan, USA) and further SFX-01 activity seen in vivo in
models of rare childhood cancer rhabdomyosarcoma (La Sapienza University,
Rome)
· Partners: Constructive discussions continue with Stalicla SA on
dispute resolution
· Board changes
o Dr Susan Foden appointed Chair, succeeding Barry Clare following his
retirement from board
o CFO Toni Hänninen appointed as Executive Director, Dr Alan Barge
appointed Senior Independent Non-executive Director; Susan Clement-Davies
retired from board
o Retirement of CFO and Executive Director, Richard Moulson
Post period Highlights
· Acquisition of Chronos Therapeutics Ltd adding substantial
pre-clinical neuropsychiatry portfolio effective 5 April 2024; integration
progressing well
o Adds addiction/anxiety/fatigue programmes in resurgent areas for pharma
· Company name change to TheraCryf plc and ticker symbol change to
TCF effective 26 April 2024
· £0.9m raised in a placing and retail offer; management and board
invested approximately 10% of the raise
Financial Highlights
Financial performance in-line with expectations:
· Post tax loss of £3.1m (2023: loss of £4.0m)
· Cash outflow from operations of £3.4m (2023: outflow of £4.9m)
· Cash and short-term investments and cash on deposit at 31 March
2024 of £2.0m (31 March 2023: £5.0m)
Outlook
· Regulatory work and approvals in support of GBM clinical trial
via the grant to Erasmus MC, Rotterdam
· Completion of integration of Chronos Therapeutics Ltd
· Grant of further patents for former Chronos programmes
· Non-dilutive Grants sought for acquired Ox-1 and DAT programmes
· Publication of clinical paper on SFX-01 Phase 1b pharmacokinetic
study
· Further PD data from SFX-01 Phase 1b study
Dr Huw Jones, CEO of TheraCryf, said:
"The past 12 months and the post period end have been transformative for the
Company. We succeeded in securing a grant for our lead clinical asset in GBM
leading to a grant funded clinical trial in patients with this devastating
disease in 2026. We observed activity of SFX-01 in models of another cancer,
colorectal and have seen further corroborative evidence of SFX-01
effectiveness in GBM models in a third academic centre. Our Phase 1b healthy
volunteer study using our commercial grade tablet of SFX-01 was successful and
will be published in due course.
"I'd like to thank former Chair Barry Clare and former NED Susan Clement
Davies for their service on our board and add my sincere thanks for the
support of Dr Susan Foden who became chair during the reporting period. Toni
Hänninen joined the company as CFO in late 2023 and the board in January
2024, we welcome and thank him for the contribution he is already making.
"Post period we acquired the neuropsychiatry company, Chronos Therapeutics,
tripling the size of our portfolio and the opportunities for monetisation. The
teams have integrated well together, and in common with the non-dilutive
funding already in place for SFX-01 in glioblastoma, we are actively seeking
non-dilutive funding for our acquired programmes.
"I am very proud of the work we have done at Evgen, and the future we have as
a broader company, now called TheraCryf. To date, we have demonstrated we can
work productively with academic centres to generate non-dilutive funding and
critical positive data. Most recently, we have also shown we are adept at the
acquisition of assets that complement our portfolio and that will ultimately
enhance shareholder value. We thank our shareholders for their loyalty in a
challenging market for public Biotech companies as we unlock the undoubted
value in our enhanced portfolio."
- Ends-
Investor FY results webinar
The TheraCryf management team will conduct a live presentation via the
Investor Meet Company webinar platform to Investors at 15.00 BST on 28 May
2024.
The online presentation is open to both existing and potential shareholders.
Questions will be addressed at the end of the presentation and may be
submitted up to 9am the day before the meeting or during the presentation via
the webinar platform.
To register, please sign up to Investor Meet Company for free and add to meet
TheraCryf via:
https://www.investormeetcompany.com/theracryf-plc/register-investor
(https://www.investormeetcompany.com/theracryf-plc/register-investor)
Investors who already follow TheraCryf on the Investor Meet Company platform
will automatically be invited.
Enquiries
TheraCryf plc +44 (0)1625 315 090
Dr Huw Jones, CEO
enquiries@theracryf.com
Toni Hänninen, CFO
Dr Helen Kuhlman, CBO
Cavendish Capital Markets (NOMAD and Broker) +44 20 7220 0500
Geoff Nash / Teddy Whiley / Rory Sale (Corporate Finance)
Nigel Birks / Harriet Ward (ECM)
Instinctif Partners +44 207 457 2020
theracryf@Instinctif.com
Melanie Toyne-Sewell / Jack Kincade
About TheraCryf plc
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.
TheraCryf is a clinical stage drug development company. The Company's lead
clinical asset, SFX-01, is a patented composition of synthetic sulforaphane
and alpha-cyclodextrin and has undergone clinical trials for
oestrogen-positive (ER+) metastatic breast cancer and most recently, a Phase
1b study of the Company's new enteric coated tablet formulation. The FDA has
granted Orphan Drug status to SFX-01 in malignant glioma. SFX-01 will be
investigated initially in this indication as an investigator sponsored study
in the Netherlands funded via a grant from the Netherlands government to the
Erasmus Medical centre, Rotterdam. TheraCryf has a wide number of
collaborations with leading academic centres in the UK, Europe and USA. The
Company completed an out-licensing transaction in 2022 with Stalicla SA, a
Swiss specialist company in neurodevelopmental disorders. The collaboration,
if successful, will generate milestone payments of $160.5m and a double-digit
royalty on sales.
TheraCryf acquired neuropsychiatry company, Chronos Therapeutics Limited, in
April 2024, which is now a wholly owned affiliate of TheraCryf plc. The
acquired assets comprise an orexin-1 antagonist (Ox-1) in late pre-clinical
development targeting impulsivity and anxiety disorders and an atypical
dopamine transporter inhibitor (DAT) also in late pre-clinical development for
fatigue, e.g. due to long COVID or multiple sclerosis and the orphan
condition, narcolepsy.
The Company has its headquarters and registered office at Alderley
Park, Cheshire. It is listed on AIM in London and trades under the ticker
symbol TCF.
For further information, please visit: www.theracryf.com
(http://www.theracryf.com) .
STRATEGIC REPORT
CHAIR'S STATEMENT
In a challenging period for non-revenue Biotech companies, we have delivered
against our strategic objectives in the year whilst conserving cash. We
completed a strategic review in the period that demonstrated the need to
broaden our pipeline and reduce reliance on a single asset. The internal focus
on SFX-01 in brain cancer coupled with an out-license transaction in
neurodevelopmental disorders led us, post period, to conclude a major
acquisition of Chronos Therapeutics Ltd, a company focused on behavioural
brain disease.
Successful delivery against our strategic objectives has included the
following: extending our cash runway through prudent financial management,
securing non-dilutive funding for our lead internal programme for SFX-01 in
GBM through to clinical evaluation and, with our other academic collaborators,
observing further evidence of potential utility of SFX-01 in cancers that we
have not studied before and that represent high unmet medical needs.
We have further characterised SFX-01 by completing the clinical study report
for our Phase 1b healthy volunteer study using our commercial grade tablet
that performed as expected. This is in readiness for interactions with
regulatory authorities as we prepare for further clinical trials in patients,
notably in GBM through our collaboration with the Erasmus Medical Centre in
the Netherlands. Initial pre-clinical results from this collaboration are
encouraging.
Whilst we have announced a dispute with our partner Stalicla SA on delivery of
a financial milestone, I am pleased to report that constructive discussions
continue on its resolution.
During the year we said goodbye to Barry Clare who retired as Chairman in
September 2023. We would like to express our gratitude and thanks to Barry for
the enormous contributions to the Company over the years. Susan Clement Davies
retired from the Board in December 2023 after five years' service to pursue
other commitments to whom we also express our thanks for her guidance and
support as a NED.
In September 2023, we extended a warm welcome to Toni Hänninen as our new CFO
and later in January 2024, as an executive director of the Company. Toni
brings considerable experience to the Company from his time in large public
and private companies and AIM listed biotech companies, most recently Faron,
and has been instrumental in the successful delivery of the acquisition of
Chronos. We are delighted to have him on board.
Post period we delivered against another strategic objective, the expansion of
our pipeline via acquisition of complementary assets. Chronos Therapeutics Ltd
has potential class leading assets in behavioural brain disorders, areas that
are both resurgent for our potential pharma partners and represent high unmet
medical needs. The accompanying small capital raise announced in early April
2024 allows us to extend our cash runway further whilst we seek non-dilutive
funding for these exciting programmes.
In this spirit, all members of the management team have foregone opportunities
for cash bonus payments for the year 2023-2024 and have agreed to take share
options to an equivalent value in their place.
I thank all the whole team for their continuing loyalty and dedication during
this time.
Finally, it gives me great pleasure to share with you that Professor Allan
Young, Chair of Mood Disorders and Director of the Centre for Affective
Disorders at the Institute of Psychiatry, Kings College London has accepted
our invitation to guide us in clinical strategic planning for our two new
assets. Allan brings extensive knowledge and experience in a wide area of
neuroscience, is recognised worldwide as a leading expert in his field and a
clinical leader in the evaluation of promising new approaches to address
complex neuropsychiatric disorders.
The board looks forward to another year of delivery on SFX-01 approaching the
first clinical trial in GBM, to completing the integration of Chronos
Therapeutics and to further funding and development of our expanded portfolio
of potentially class-leading medicines.
Dr Susan Foden
Chair
CHIEF EXECUTIVE'S REVIEW OF PERFORMANCE
The past year has been one of delivery against challenging objectives with the
backdrop of a difficult market for listed biotech companies.
We have responded positively to the environmental headwinds by securing
non-dilutive funding for our lead clinical stage programme in GBM that enables
us to study SFX-01 in patients in early 2026. We have also completed to a
regulatory standard, the report on our internally funded Phase 1b study on our
commercial grade SFX-01 tablet. More data on the pharmacodynamic effects of
SFX-01 in this healthy volunteer study are being generated and will be made
public in due course. We have continued to optimise manufacturing for SFX-01
in preparation for administration of these novel SFX-01 tablets to patients.
Our pre-clinical academic collaborations continue to deliver positive data on
SFX-01 in cancers that we have not hitherto studied and that represent high
unmet medical needs including the childhood cancer rhabdomyosarcoma and one of
the most common malignancies worldwide, colorectal cancer.
Immediately post period we concluded an acquisition that was a long standing
internal strategic objective. We performed an extensive worldwide search of
companies or assets that were complementary to our existing portfolio and core
competencies and concluded that the behavioural brain disease company Chronos
Therapeutics in Oxford, UK was the best fit of hundreds of opportunities we
evaluated. We acquired Chronos in early April of this year and are in advanced
stages of completing the integration of the company. The pre-clinical
neuropsychiatry assets within Chronos represent potentially class leading
profiles in addiction/impulsivity/anxiety and in fatigue and the orphan
condition, narcolepsy. The programmes fit well with our business model and
represent a substantial expansion and diversification of our research
pipeline.
Looking forward we are focussed on preparing SFX-01 for the grant funded
clinical study in GBM patients, to continuing to work amicably with our
partner Stalicla and to unlocking the value of our acquisition of Chronos
whilst remaining true to our 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 was awarded orphan drug status in this indication by the US FDA in late
2021 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 reporting period our collaborator Dr Marjolein Geurts,
neuro-oncologist at the Erasmus Medical Centre Rotterdam, NL was awarded a
grant from the Netherlands government administered by the Dutch cancer
society, KWF for a €1.1m total project value. The grant was for in vitro, in
vivo pre-clinical experiments on SFX-01 followed by a window of opportunity
clinical study in GBM patients. The project started on schedule in October
2023 with in vitro experiments from tumour tissue donated by patients at Dr
Geurts' clinic. SFX-01 was shown to be active in these samples, corroborating
prior published work from our 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
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 from SFX-01
enters the tumour tissue in patients and also to assess interactions of the
agent with molecular targets in excised tumour tissue.
Phase1/1b Human Volunteer Study
A Phase 1/1b study in healthy volunteers of our novel SFX-01 formulation was
completed in 2023. The trial comprised three cohorts of eight volunteers each,
of which two in each cohort received a placebo. The trial was randomised and
double-blinded. All participants had received their final dose on schedule by
the end of January 2023. Analysis of the pharmacokinetic (PK) data was
completed whilst analysis of effects of SFX-01 administration on gene
expression data on the entire genome of the volunteers on active drug and
placebo is underway.
During the period, 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 reliable 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 profound biological activity.
There were no serious adverse events reported. The Company plans to publish
the study in a reputable, peer reviewed research journal in 2024. As further
data on the pharmacodynamic effect of SFX-01 on whole genome expression vs
placebo in these volunteers become available, they will be made public.
PRE-CLINICAL PROGRAMMES
We continue to support academic research to broaden the potential range of
applications for SFX-01 and increase our mechanistic understanding in various
disease areas of high unmet medical need.
Erasmus Medical Centre (MC) Rotterdam, Netherlands
As described in the clinical section above, experiments conducted under the
Dutch government grant to the Erasmus MC using tissue from GBM tumours has
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, in May 2022 the
Company commenced a collaboration 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
results were presented in a poster at the ESMO Sarcoma and Rare Cancers
Congress (March 2023), in Lugano Switzerland.
During the reporting period these experiments were 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. These data are due to be submitted
for publication in a peer reviewed journal once finalised.
University of Michigan
Colorectal cancer is considered to be the third most common form of cancer
worldwide, with between 1.5-2 million annual diagnoses, and the second leading
cause of cancer-related deaths. There has also been an alarming global rise
in early-onset colorectal cancer occurring in individuals under 50 years of
age. Treating colorectal cancers can be difficult and does not always lead
to a cure especially in advanced stages. Therefore, there is a strong need
to develop chemoprevention strategies as well as better treatment options.
A collaboration with the laboratories of Professor Grace Chen, Associate
Professor Justin Colacino, and Professor Duxin Sun at the University
of Michigan, USA have generated data during 2024 where activity of SFX-01
was observed in models of colon cancer. The in vitro and in vivo studies,
funded by the USA National Cancer Institute and the University
of Michigan will be generating data continuously throughout the project. The
project is ongoing and further data will be made public in due course.
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 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 (anticipated by the end of 2024. Total milestones of up to
$160.5m are payable. Royalties payable to us 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 we gave a notice of dispute to Stalicla. The TheraCryf board
of directors believes that the Company has met the terms required to satisfy
the milestone, according to the License Agreement, and thus the payment 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 in the half year results in October 2023, we have not anticipated
any milestone payments from Stalicla in our financial forecasting and our cash
runway remains unchanged. We continue to discuss amicably with Stalicla board
members a route to resolve the current dispute and will provide updates once
these discussions conclude.
PEOPLE
After a substantial period chairing the board both as a private and public
company since 2007, founding Chair Barry Clare announced his intention to
retire from the board. This was effective on 21 September 2023.
Dr Susan Foden, previously senior independent non-executive director was
appointed Chair from the same date. Dr Alan Barge, previously NED became
senior independent non-executive director and chair of the Remuneration and
audit committees on Dr Foden's appointment as Chair.
After five years as a non-executive director of the Company, Susan
Clement-Davies retired from the board effective on 31 December 2023.
Following an extensive recruitment project through an executive search
company, Toni Hänninen agreed to serve as Chief Financial Officer in
September 2023. He was appointed to the Board as an Executive director in
January 2024.
The Company would like to thank former Chair, Barry Clare and former NED,
Susan Clement Davies for their service on the board and add our sincere thanks
for the support of Dr Susan Foden who became chair during the reporting
period. Toni Hänninen joined the company as CFO in late 2023 and the board in
January 2024, and is already making a significant contribution.
POST PERIOD EVENTS
In April 2024 the Company announced that, following a general meeting, it had
agreed to acquire the entire issued share capital of Chronos Therapeutics
Limited (Chronos), for an initial consideration of £899,481 payable in
Ordinary Shares at a price of 1.44 pence per Ordinary Share, potentially
increasing to up to c.£3.4 million subject to the achievement of certain
milestones (the "Acquisition"). The Company further announced that it had
raised £0.85 million (before expenses) via a Placing and Subscription and a
further £0.05 million via a retail offer making gross proceeds of £0.9m.
Over 10% of the proceeds were via participation in placing or subscription by
the Company's board and management.
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 the orphan
condition 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 this enhancing shareholder value.
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.
OUTLOOK
The outlook for the coming year is looking promising, including non-dilutive
funding, high quality academic collaborations and our recent acquisition and
new programmes. We look forward to supporting the grant funded work for SFX-01
on GBM in Rotterdam. This will lead to a clinical trial in this devastating
disease once our manufacturing and increased interactions with European
regulatory authorities are complete. We expect the start of clinical read outs
in in GBM during 2026. We anticipate publication of our Phase 1/1b PK study in
a peer reviewed journal in the coming year and to making public the effects of
SFX-01 on gene expression data versus placebo from the same study. Our
pre-clinical collaborations continue to generate data on the effectiveness of
SFX-01 as a sole agent and as an enhancer of radiotherapy and we anticipate
more data from those collaborations in the coming year.
We will continue to protect our intellectual property, with the grant of
further composition of matter patents on our acquired neuropsychiatry assets
from Chronos. We also plan the development of at least one of those assets via
non-dilutive funding in 2024/25.
With an extended cash runway an expanded, balanced and risk-adjusted
portfolio, we believe that we have the strategy and team to deliver
substantial shareholder value at a difficult time. Thank you to our loyal
shareholders for their commitment and support.
Dr Huw Jones
CEO
Financial Review
The financial performance for the year ended 31 March 2024 was in line with
expectations.
Losses
The total loss for the year was £3.1m (31 March 2023: £4.0m) including a
charge for share-based compensation of £0.1m (2023: £0.2m). Operating
expenses excluding share-based compensation were lower than in 2023 at £3.8m
(2023: £5.4m) due to less manufacturing costs incurred in 2024.
Research and development (R&D) expenditure
Our external spend on R&D expenditure decreased by £1.6m on the prior
year to £1.7m (31 March 2023: £3.3m). This reflects reduction of product
manufacturing work and earlier completion of our Phase 1/1b clinical study.
Share-based compensation
Accounting standards require a charge to be made against the grant of share
options and recognised in the Consolidated Statement of Comprehensive Income.
Where such options lapse ahead of their vesting date the relevant charges are
written back. There was an overall charge for the year in relation to
share-based payments of £0.1m (2023 : £0.2m), which has no impact on cash
flows.
Headcount
Average headcount of the Group for the year was 9 (2023: 10).
Taxation
The Group has elected to claim research and development tax credits under the
small or medium enterprise research and development scheme of £0.43m (2023:
£0.96m).
Share capital
No issues of shares were made during the year. At 31 March 2024 and 31 March
2023 there were 274,888,117 shares of 0.25p each in issue.
Cash flows and financial position
The cash position (including short term deposits) at 31 March 2024 decreased
to £2.0m (31 March 20223: £5.0m) reflecting R&D and corporate costs,
less £0.91m received from R&D tax credits.
Principal Risks and Uncertainties
TheraCryf is a biopharmaceutical company and, in common with other companies
operating in the sector, is subject to a number of risks. The principal risks
and uncertainties identified by the Group for the year ending 31 March 2024
are set out below.
Development
The Group is at a relatively early stage of development and may not be
successful in its efforts to develop approved or marketable products.
Technical risk is present at each stage of the development process which is a
highly regulated environment which presents technical and operational risk.
There can be no guarantee that the Group will be able to, or that it will be
commercially advantageous for the Group to, develop its Intellectual Property
through entering into licensing deals with pharmaceutical companies.
Commercial
The biotechnology and pharmaceutical industries are very competitive. The
Group's competitors include major multinational pharmaceutical companies,
biotechnology companies and research institutions. Many of its competitors
have substantially greater financial, technical and other resources. The
Group's competitors may succeed in developing, acquiring or licensing drug
product candidates that are more effective or less costly than those the Group
is developing, or may develop, and this may have a material adverse impact on
the Group.
Regulatory
The Group's operations are subject to laws, regulatory approvals, and certain
government directives, recommendations and guidelines. There can be no
assurance that future legislation will not impose further government
regulation which may adversely affect the business or financial condition of
the Group.
Intellectual property (IP)
The Group's success depends in part on its ability to obtain and maintain
patent protection for its technology and potential products in the United
States, Europe and other countries. If the Group is unable to obtain and
maintain patent protection for its technology and potential products, or if
the scope of patent protection is not sufficiently broad, competitors could
develop and commercialise similar technology and products, which could
materially affect the Group's ability to successfully commercialise its
technology and potential products. The Group is exposed to additional IP
risks, including infringement of IP rights, involvement in lawsuits and the
inability to protect the confidentiality of its trade secrets which could have
an adverse effect on the success of the Group.
Financial
The Group has a limited operating history, has incurred significant losses
since its inception and does not have any approved or revenue generating
products. The Group expects to incur losses for the foreseeable future, and
there is no certainty that the business will generate a profit. The Group may
not be able to raise additional funds that will be required to support its
product development programs or commercialisation efforts, and any additional
funds that are raised may cause dilution to existing shareholders.
Operational
The Group's future development and prospects depend to a material extent on
the experience, performance and continued service of its senior management
team including the Directors. The Directors believe the senior management team
is appropriately structured for the Group's size and stage of development and
is not overly dependent on any one individual. The Group has entered into
contractual arrangements with these individuals with the aim of securing the
services of each of them. Retention of these services or the identification of
suitable replacements cannot be guaranteed. The loss of the service of any of
the Directors or senior management and the cost of recruiting replacements may
have a material adverse effect on the Group and its commercial and financial
performance.
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
for the year ended 31 March 2024
Year ended 31 March 2024 Year ended 31 March 2023
Notes £'000 £'000
Revenue 396 442
Operating expenses
Operating expenses 5 (3,825) (5,389)
Share based compensation 4 (137) (157)
Total operating expenses (3,962) (5,546)
Operating loss 5 (3,566) (5,104)
Finance income - 98
Loss on ordinary activities before taxation (3,566) (5,006)
Taxation 429 963
Loss and total comprehensive expense attributable to equity holders of the (3,137) (4,043)
parent for the year
Loss per share attributable to equity holders of the parent (pence) 6
Basic loss per share (1.14) (1.47)
Diluted loss per share (1.14) (1.47)
CONSOLIDATED AND COMPANY STATEMENTS OF FINANCIAL POSITION
as at 31 March 2024
Group Company
Restated Restated
As at As at As at As at As at
31 March 2024 31 March 31 March 2024 31 March 2023 31 March 2022
2023
£'000 £'000 £'000 £'000 £'000
ASSETS
Non-current assets
Property, plant and equipment - 3 - 2 3
Intangible assets 34 43 - - -
Investments in subsidiary undertaking - - 73 73 73
Balances due from group undertaking - - 10,181 10,281 10,376
Total non-current assets 34 46 10,254 10,356 10,452
Current assets
Trade and other receivables 595 216 594 185 111
Current tax receivable 429 912 385 842 361
Short-term investments and cash on deposit - - - - 4,520
Cash and cash equivalents 2,004 5,000 1,953 4,708 3,812
Total current assets 3,028 6,128 2,932 5,735 8,804
Total assets 3,062 6,174 13,186 16,091 19,256
LIABILITIES AND EQUITY
Current liabilities
Trade and other payables 722 833 708 786 369
Total current liabilities 722 833 708 786 369
Equity
Ordinary shares 687 687 687 687 687
Share premium 27,870 27,870 27,870 27,870 27,870
Merger reserve 2,067 2,067 - - -
Share based compensation 635 509 635 509 490
Retained deficit (28,918) (25,792) (16,714) (13,761) (10,160)
Total equity attributable to equity holders of the parent 2,341 5,341 12,478 15,305 18,887
Total liabilities and equity 3,062 6,174 13,186 16,091 19,256
No Statement of Comprehensive Income is presented in these financial
statements for the parent company as provided by Section 408 of the Companies
Act 2006. The loss for the financial year dealt with in the financial
statements of the parent company was £2,963k (2023: £3,739k).
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
for the year ended 31 March 2024
Ordinary Share Merger Share based Retained
shares premium reserve compensation deficit Total
£'000 £'000 £'000 £'000 £'000 £'000
Balance at 31 March 2022 687 27,870 2,067 490 (21,887) 9,227
Total comprehensive expense for the period - - - - (4,043) (4,043)
Transactions with owners
Share issue - lapsed options - - - (138) 138 -
Share based compensation - share options - - - 157 - 157
Total transactions with owners - - - 19 138 157
Balance at 31 March 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 AND COMPANY STATEMENTS OF CASH FLOWS
for the year ended 31 March 2024
Group Company
Year ended 31 March 2024 Year ended 31 March 2023 Year ended 31 March 2024 Year ended 31 March 2023
£'000 £'000 £'000 £'000
Cash flows from operating activities
Loss before taxation (3,566) (5,006) (3,351) (4,628)
Interest (income) / expense - (98) - (98)
Depreciation and amortisation 12 13 2 1
Share based compensation 137 157 137 157
(3,417) (4,934) (3,212) (4,568)
Changes in working capital
(Increase)/decrease in trade and other receivables (379) (91) (309) 21
(Decrease)/increase in trade and other payables (113) 423 (78) 417
Cash used in operations (492) 332 (387) 438
Taxation received 913 475 844 408
Net cash used in operating activities (2,996) (4,127) (2,755) (3,722)
Cash flows (used in)/generated from investing activities
Transfer from Short-term investments and cash on deposit to Cash and cash - 4,520 - 4,520
equivalents
Interest income / (expense) - 98 - 98
Acquisition of tangible fixed assets - (1) - -
Net cash (used in)/generated from investing activities - 4,617 - 4,618
Movements in cash and cash equivalents in the period (2,996) 490 (2,755) 896
Cash and cash equivalents at start of period 5,000 4,510 4,708 3,812
Cash and cash equivalents at end of period 2,004 5,000 1,953 4,708
NOTES TO THE FINANCIAL STATEMENTS
1. GENERAL INFORMATION
Theracryf plc (formerly Evgen Pharma plc) ('the Company') is a public limited
company incorporated in England & Wales and whose shares are traded on the
AIM market of the London Stock Exchange under the symbol EVG. The address of
its registered office is Alderley Park, Congleton Road, Nether Alderley,
Cheshire, United Kingdom, SK10 4TG. The principal activity of the Company is
clinical stage drug development.
Change of Company Name Disclosure
The Company changed its name from Theracryf plc to Evgen Pharma plc on 25
April 2024. This change of name has been reflected in the financial statements
and all necessary legal and regulatory requirements have been complied with.
2. SIGNIFICANT ACCOUNTING POLICIES AND BASIS OF PREPARATION
Basis of preparation
The financial statements for the year have been prepared in accordance with
applicable law and UK adopted international accounting standards and, as
regards the parent company financial statements, as applied in accordance with
the provisions of the Companies Act 2006.
The consolidated financial statements have been prepared under the historical
cost convention.
The consolidated financial statements are presented in Sterling (£) and
rounded to the nearest £'000. This is the predominant functional currency of
the Group, and is the currency of the primary economic environment in which it
operates. Foreign transactions are accounted for in accordance with the
policies set out below.
The financial information does not include all information required for full
annual financial statements and therefore does not constitute statutory
accounts within the meaning of section 435(1) and (2) of the Companies Act
2006 or contain sufficient information to comply with the disclosure
requirements of UK-adopted International Accounting Standards. These should be
read in conjunction with the Financial Statements of the Group for the year
ended 31 March 2024 which were approved by the Board of Directors on 27 May
2024. The report of the auditors for the year ended 31 March 2024 was (i)
unqualified, (ii) did not include a reference to any matters to which the
auditors drew attention by way of emphasis without qualifying their report,
and (iii) did not contain a statement under section 498 (2) or (3) of the
Companies Act 2006.
Basis of consolidation
The financial statements incorporate the financial statements of the Company
and entities controlled by the Company. Control is achieved when the Company
has the power over the investee; is exposed, or has rights, to variable return
from its involvement with the investee; and, has the ability to use its power
to affect its returns. The Company reassesses whether it controls an investee
if facts and circumstances indicate that there are changes to one or more of
the three elements of control listed above.
Consolidation of a subsidiary begins when the Company obtains control over the
subsidiary and ceases when the Company loses control of the subsidiary.
Specifically, the results of subsidiaries acquired or disposed of during the
period are included in the Consolidated Statement of Comprehensive Income from
the date the Company gains control until the date when the Company ceases to
control the subsidiary.
Where necessary, adjustments are made to the financial statements of
subsidiaries to bring the accounting policies used into line with the Group's
accounting policies.
All intragroup assets and liabilities, equity, income, expenses and cash flows
relating to transactions between the members of the Group are eliminated on
consolidation.
3. GOING CONCERN
At 31 March 2024, the Group had cash and cash equivalents of £2.0 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 coming cash flow predictions are based upon a period of closely controlled
cash flows in order to maintain ongoing development at a level fit to our
means. Non - dilutive sources of funding are being explored in order to
accelerate development of the Chronos portfolio in line with our corporate
objectives.
The Directors estimate that the cash held by the Group together with known
receivables will be sufficient to support the current level of activities into
the fourth quarter of 2025. They have therefore prepared the financial
statements on a going concern basis.
4. SHARE-BASED PAYMENT CHARGE
During the year ended 31 March 2024, the Group did not issue any new share
options. There were several options issued to certain employees in the year
ended 31 March 2023. A Black-Scholes model was used to calculate the
appropriate charge for these periods. The use of this model to calculate a
charge involves using a number of estimates and judgements to establish the
appropriate inputs to be entered into the model, covering areas such as the
use of an appropriate risk-free rate and dividend rate, exercise restrictions
and behavioural considerations. A significant element of judgement is
therefore involved in the calculation of the charge. The total charge
recognised in the year to 31 March 2024 was £136,554 (year to 31 March 2023:
£156,809).
5. OPERATING LOSS
An analysis of the Group's operating loss has been arrived at after
charging/(crediting)
Year ended 31 March 2024
Year ended 31 March 2023
£'000 £'000
Research and development expenses:
Amortisation of licenses 9 10
Other research and development 1,727 3,330
Staff costs (including share based compensation) - Note 6 1,043 1,390
Establishment and general:
Depreciation of property, plant and equipment 3 3
Operating lease cost - land and buildings 15 14
Foreign exchange loss/(profit) 6 34
Other administrative expenses 1,159 765
Total operating expenses 3,962 5,546
The Group has one reportable segment, namely the development of pharmaceutical
products all within the United Kingdom.
6. 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 year.
As at 31 March 2024 the Group had 14,574,910 (2023: 20,730,037) share options
outstanding which are potentially dilutive.
The calculation of the Group's basic and diluted loss per share is based on
the following data:
Year ended 31 March 2024
Year ended 31 March 2023
£'000 £'000
Loss for the year attributable to equity holders for basic loss and adjusted (3,137) (4,043)
for the effects of dilution
Year ended 31 March 2024
Year ended 31 March 2023
Number Number
Weighted average number of ordinary shares for basic loss per share 274,888,117 274,888,117
Effects of dilution:
Share options - -
Weighted average number of ordinary shares adjusted for the effects of 274,888,117 274,888,117
dilution
Year ended 31 March 2024
Year ended 31 March 2023
Pence Pence
Loss per share - basic and diluted (1.14) (1.47)
The weighted average numbers of ordinary shares for the years ended 31 March
2023 and 2024 used for calculating the diluted loss per share are identical to
those for the basic loss per share. This is because the outstanding share
options would have the effect of reducing the loss per ordinary share and
would therefore not be dilutive under the terms of International Accounting
Standard (''IAS'') No 33.
7. ISSUED CAPITAL AND RESERVES
Group and Company
Ordinary shares of 0.25p each Share Capital Share Premium Total
Number £'000 £'000 £'000
As at 31 March 2023 & 31 March 2024 274,888,117 687 27,870 28,557
There were no new shares issued in the year ending 31 March 2024.
All shares in issue are fully paid.
The ordinary shares rank pari passu in all respects in relation to dividends
and repayment of capital and have equal voting rights with one vote per share.
There are no restrictions on the transferability of the shares.
The Group and Company do not have an authorised share capital as provided by
the Companies Act 2006.
Other reserves
The share premium reserve represents the difference between the net proceeds
of equity issues and the nominal share capital of the shares issued.
The merger reserves at 31 March 2024 and 2023 arose from the acquisition of
Theracryf's sole subsidiary, Theracryf Pharma Limited (formerly Evgen
Limited), in 2014 which is accounted for using the merger method of
accounting.
The share-based compensation reserve reflects the aggregate fair value of
equity-settled share-based payment transactions.
Reserves classified as retained deficit represent accumulated losses. None of
the reserves are distributable.
8. RELATED PARTY TRANSACTIONS
Group
Transactions between the Company and its subsidiaries, which are related
parties, have been eliminated on consolidation and are not disclosed in this
note.
Key management compensation and Directors' emoluments are disclosed in the
Remuneration Committee Report of the Annual Report.
During the year ended 31 March 2024, the Group purchased consultancy services
totalling £nil (year ended 31 March 2023: £2,630) from FD Consult Ltd, a
company controlled by Richard Moulson. The amount owed to FD Consult Ltd at 31
March 2024 was £nil (31 March 2023: £nil).
During the year the Group purchased services from Biotech industry membership
organisation OBN Ltd, a company for which Huw Jones acts as a non-executive
director, totalling £1,440 (2023: £1,440). The amount owed to OBN at 31
March 2024 was £nil (31 March 2023: £nil).
During the year the Group purchased services from Daffodil Consulting LLP, a
partnership for which Huw Jones is a designated member, totalling £9,689
(2023: £9,176). The amount owed to Daffodil Consulting LLP at 31 March 2024
was £867 (31 March 2023: £nil).
During the year the Group purchased services from Borealito GmbH, a company
controlled by Toni Hänninen, totalling £98,766 (2023: £nil). The amount
owed to Borealito GmbH at 31 March 2024 was £20,632 (31 March 2023: £nil).
Company
The Company is responsible for financing and setting Group strategy. The
Company's subsidiary carried out the Group's development strategy and managed
the Group's intellectual property. The Company provides interest free and
unsecured funding to its subsidiary with no fixed date of repayment. Details
of intercompany balances can be found in Note 12 in the Annual Report.
9. REPORT AND ACCOUNTS
A copy of the Annual Report and Accounts will shortly be sent to all
shareholders shortly with notice of the Annual General Meeting and will also
be available to download from the Group's website at www.theracryf.com
(http://www.theracryf.com) .
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