19 April 2024
Biodexa Pharmaceuticals
PLC(“Biodexa” or the “Company” or, together with its
subsidiaries, the “Group”)
Preliminary Results for the Year Ended 31
December 2023
Biodexa Pharmaceuticals PLC (NASDAQ: BDRX), a
clinical stage biopharmaceutical company developing a pipeline of
products aimed at primary and metastatic cancers of the brain,
announces its audited preliminary results for the year ended 31
December 2023.
For more information, please contact:
Biodexa Pharmaceuticals PLC |
Stephen Stamp, CEO, CFO |
Tel: +44 (0)29 2048 0180 |
www.biodexapharma.com |
About Biodexa Pharmaceuticals
PLC
Biodexa Pharmaceuticals PLC (listed on NASDAQ:
BDRX) is a clinical stage biopharmaceutical company developing a
pipeline of innovative products for the treatment of diseases with
unmet medical needs. The Company’s lead development programmes
include tolimidone, under development as a novel agent for the
treatment of type 1 diabetes and MTX110, which is being studied in
aggressive rare/orphan brain cancer indications.
Tolimidone is an orally delivered, potent and
selective inhibitor of Lyn kinase. Lyn is a member of the Src
family of protein tyrosine kinases, which is mainly expressed in
hematopoietic cells, in neural tissues, liver, and adipose tissue.
Tolimidone demonstrates glycemic control via insulin sensitization
in animal models of diabetes and has the potential to become a
first in class blood glucose modulating agent.
MTX110 is a solubilised formulation of the
histone deacetylase (HDAC) inhibitor, panobinostat. This
proprietary formulation enables delivery of the product via
convection-enhanced delivery (CED) at chemotherapeutic doses
directly to the site of the tumour, by-passing the blood-brain
barrier and potentially avoiding systemic toxicity.
Biodexa is supported by three proprietary drug
delivery technologies focused on improving the bio-delivery and
bio-distribution of medicines. Biodexa’s headquarters and R&D
facility is in Cardiff, UK. For more information visit
www.biodexapharma.com.
Forward-Looking Statements
Certain statements in this announcement are
forward-looking statements or information (collectively,
forward-looking statements). Biodexa hereby provides cautionary
statements identifying important factors that could cause the
actual results to differ materially from those projected in the
forward-looking statements. Any statements that express, or involve
discussions as to, expectations, beliefs, plans, objectives,
assumptions or future events or performance (often, but not always,
through the use of words or phrases such as “may”, “is expected
to”, “anticipates”, “estimates”, “intends”, “plans”, “projection”,
“could”, “vision”, “goals”, “objective” and “outlook”) are not
historical facts and may be forward-looking and may involve
estimates, assumptions and uncertainties which could cause actual
results or outcomes to differ materially from those expressed in
the forward-looking statements.
By their nature, forward-looking statements
involve numerous assumptions, inherent risks and uncertainties,
both general and specific, which contribute to the possibility that
the predicted outcomes may not occur or may be delayed. The risks,
uncertainties and other factors many of which are beyond the
control of Biodexa, that could influence actual results include,
but are not limited to: a limited operating history; regulatory
risks; substantial capital and liquidity requirements; financing
risks and dilution to shareholders; competition; reliance on
management and dependence on key personnel; conflicts of interest
of management; exposure to potential litigation, and other factors
beyond the control of Biodexa.
Forward looking statements are based on
estimates and assumptions made by management in light of their
experience of historical trends, current conditions and expected
future developments, as well as factors that are believed to be
appropriate. Such factors include, among others, Biodexa’s future
product revenues, stage of development, additional capital
requirements, risks associated with the completion and timing of
clinical trials and obtaining regulatory approval to market
Biodexa’s products, the ability to protect its intellectual
property, dependence upon collaborative partners, changes in
government regulation or regulatory approval processes and rapid
technological change in the industry. These factors should be
considered carefully and readers are cautioned to not place undue
reliance on such forward-looking statements.
Further, any forward-looking statement speaks
only as of the date on which such statement is made, and, except as
required by applicable law, Biodexa undertakes no obligation to
update any forward-looking statement to reflect events or
circumstances after the date on which such statements are made or
to reflect the occurrence of unanticipated events. New factors
emerge from time to time, and it is not possible for management to
predict all such factors and to assess in advance the impact of
each such factor on the business of the Company or the extent to
which any factor, or combination of factors, may cause actual
results to differ materially from those contained in any
forward-looking statement.
Comparisons of results for current and any prior
periods are not intended to express any future trends or
indications of future performance, unless expressed as such, and
should only be viewed as historical data. You should, however,
review the factors and risks we describe in the reports we will
file from time to time with the US Securities and Exchange
Commission after the date of this announcement. As a result of
these factors, we cannot assure you that the forward-looking
statements in this announcement will prove to be accurate.
Furthermore, if our forward-looking statements prove to be
inaccurate, the inaccuracy may be material. In light of the
significant uncertainties in these forward-looking statements, you
should not regard these statements as a representation or warranty
by us or any other person that we will achieve our objectives and
plans in any specified timeframe, or at all.
INTRODUCTION
Headquartered in Cardiff, UK, with its American
Depositary Shares (“ADSs”) quoted on the NASDAQ exchange in the US,
Biodexa is a clinical-stage biotechnology company developing a
pipeline of innovative products for the treatment of diseases with
unmet medical needs including Type 1 diabetes and rare / orphan
brain cancers. The Company de-listed from the AIM market as of 26
April 2023.
STRATEGY
In the course of seeking additional funding for
the Company, it became clear that raising significant funds for a
drug delivery platform company was going to be difficult, if not
impossible, in the then prevailing financial markets. Accordingly,
we decided to re-position the Company as a therapeutics company and
began looking for assets to complement our MTX110 programmes.
Following the re-positioning of the Company, our
priorities for 2024 reflect our modified strategy as follows:
Strategic Imperatives |
Progress in 2023 |
Priorities for 2024 |
|
|
|
Advance our clinical -stage assets through to proof-of-concept
data |
We announced the completion of recruitment into Cohort A of our
MAGIC-G1 study of MTX110 in patients with recurrent glioblastoma
(rGBM).In an Investigator Initiated Trial, Columbia University
completed recruitment of a Phase I study of MTX110 in patients with
Diffuse Midline Glioma (DMG). |
In respect of our Phase I study in rGBM, deliver interim safety and
efficacy data (in the form of Progression Free Survival data) in
respect of Cohort A patients and begin recruitment of Cohort B
patients.Initiate recruitment of a Phase IIa dose confirmation
study of tolimidone in Type 1 diabetes patients.Seek an IND from
FDA to commence a Phase II study of MTX110 in DMG. |
Develop and broaden our drug development pipeline |
We in-licensed tolimidone, a Phase II ready asset with very
substantial preclinical and toxicology data which has been studied
in over 700 patients. In preclinical experiments, tolimidone showed
potential to be disease modifying in Type 1 diabetes.We initiated a
new research programme, coded MTD217, to explore the potential for
MTX110 in combination with an OXPHOS inhibitor for the treatment of
Leptomeningeal Disease, a severe complication of solid cancers with
metastasis in the leptomeningeal space of the CNS. |
Generate in vitro data to support the disease modifying potential
of tolimidone in Type 1 diabetes.Generate in vitro and in vivo data
to demonstrate the effectiveness of MTD217 in Leptomeningeal
Disease models.Seek additional pre-IND and/or clinical-stage assets
to acquire or in-license.Expand further our patent portfolio to
cover new inventions and divisionals to strengthen existing patent
families. |
Provide a healthy and stimulating environment in which our staff
members can continue to thrive |
We have been compliant with ISO 9001 since 2014. Implement the new
COSHH assessment procedures developed in 2023. |
Continue to monitor third party advice and regulation to maintain a
safe environment for our staff members.Develop individualised
learning programmes for staff members through participation in
conferences, webinars and/or training programmes. |
BUSINESS MODEL
In order to make the Company more investable and
secure additional financing, the Board decided to re-position the
Company as a therapeutics (as opposed to drug delivery) company in
early 2023. As a result, the delivery of proof-of-concept clinical
data is the primary focus of our business model going forward.
Development
Our intention is to build a balanced portfolio
of clinical-stage development assets, ideally with a focus on rare
/ orphan indications. Tolimidone, which was in-licensed in December
2023, is a Phase II ready asset which we intend to develop for Type
1 diabetes. MTX110 is currently in Phase I development for three
rare / orphan brain cancers.
Our aim is to develop our clinical assets to
proof of concept stage before securing partners to undertake the
most expensive, later stage development.
Manufacturing
We do not intend to establish our own
manufacturing capabilities. For clinical trial material we utilise
GMP-certified contract manufacturers.
Commercialisation
Once proof-of-concept has been established, we
intend to seek to license our products to a partner who would
complete the clinical development and subsequently market and sell
them in the licensed territory. In addition to reimbursement of
development costs, the partner would be expected to make milestone
payments based on sales targets and royalty payments.
Our development pipeline now includes five
projects, four of which are at clinical stage, as follows:
CLINICAL-STAGE ASSETS
Tolimidone
Tolimidone was originally discovered by Pfizer
Inc. (“Pfizer”) and was developed through Phase II for the
treatment of gastric ulcers. Pfizer undertook a broad pre-clinical
program to characterise the pharmacology, pharmacokinetics,
metabolism and toxicology of tolimidone. Pfizer discontinued
development of the drug due to lack of efficacy for that indication
in Phase II. Tolimidone is a selective activator of the enzyme Lyn
kinase which increases phosphorylation of insulin substrate -1,
thereby amplifying the signalling cascade initiated by the binding
of insulin to its receptor.
We intend to develop tolimidone for the
treatment of Type-1 diabetes (“T1D”). As a Lyn kinase activator,
tolimidone has been shown in preclinical experiments to have a role
in beta cell survival and proliferation. If replicated in clinical
studies, tolimidone could have the potential to be disease
modifying and change the treatment paradigm for T1D. T1D affects
approximately 8.4 million people worldwide and there are
approximately 500,000 new diagnoses per annum.
As a first step in the planned continued
clinical development of tolimidone, we intend to initiate a Phase
IIa dose confirmation study to establish the optimum dose of
tolimidone in patients with T1D. The Phase IIa study will be
open-label in approximately 15 patients with T1D treated over a
period of three months with endpoints of change in C-peptide
levels, HbA1c and number of hyperglycaemic events.
MTX110
Using our MidaSolve technology in combination
with panobinostat, an otherwise insoluble drug, MTX110 is designed
for direct-to-tumour administration via a catheter system
(Convection Enhanced Delivery, or "CED") thereby bypassing the
blood-brain barrier and allowing for high drug concentrations and
broader drug distribution in and around the tumour while
simultaneously minimising systemic toxicity and other side effects.
Panobinostat is currently marketed under the brand Farydak® which
is used orally in combination therapy for the treatment of multiple
myeloma. We are currently researching the utility of MTX110 to
proof of concept stage in three indications:
Glioblastoma Multiforme (GBM):GBM is the most
common and aggressive form of brain cancer in adults, usually
occurring in the white matter of the cerebrum. Treatments include
radiation, surgical resection and chemotherapy although, in almost
all cases, tumours recur. There are approximately 2-3/100,000(1)
population diagnoses of GBM per annum. Survival with standard of
care treatment ranges from approximately 13 months in unmethylated
MGMT patients to approximately 30 months in highly methylated MGMT
patients(2). Once it has recurred, median survival is 6.5
months(3).
During 2023 we completed recruitment of patients
in the first cohort of a Phase I study to assess the utility of
MTX110 in recurrent GBM. The Phase I study is an open-label, dose
escalation study designed to assess the feasibility and safety of
intermittent infusions of MTX110 administered by convection
enhanced delivery (CED) via implanted refillable pump and catheter.
The study aims to recruit two cohorts, each with a minimum of four
patients; the first cohort received MTX110 only and the second
cohort will also receive MTX110 but, at the option of the treating
clinician, the catheter may be re-positioned once recurrence
occurs.
Diffuse Midline Glioma (DMG), formerly known as
Diffuse Intrinsic Pontine Glioma, or DIPG:DMG tumours are located
in the pons (middle) of the brain stem and are diffusely
infiltrating. Occurring mostly in children, approximately 1,000
patients(4) worldwide are diagnosed with DIPG per annum and median
survival is approximately 10 months(5). There is no effective
treatment since surgical resection is not possible. The standard of
care is radiotherapy, which transiently improves symptoms and
survival. Chemotherapy does not improve survival and one likely
reason is that many anti-cancer drugs cannot cross the blood-brain
barrier to access the tumour.
In October 2020, we reported the first-in-human
study by the University of California, San Francisco (“UCSF”) of
MTX110 in DIPG using a convection enhanced delivery (“CED”) system.
The Phase I study established a recommended dose range for Phase
II, a good safety and tolerability profile but also encouraging
median survival data of 26 months in the seven patients
treated.
An additional Phase I Investigator Initiated
Trial by Columbia University is expected to report data in 2Q24.
Thereafter, we intend to explore the possibility of seeking an IND
for a Phase II study of MTX110 in
DMG.Medulloblastoma:Medulloblastomas are malignant embryonal
tumours that start in the cerebellum. They are invasive and, unlike
most brain tumours, spread through the cerebrospinal
fluid (“CSF”) and frequently metastasize to
different locations in the brain and spinal cord. Treatments
include resection, radiation and chemotherapy. Approximately 350
patients(6) are diagnosed with medulloblastoma per annum and 3,800
people are living with the disease in the US. The cumulative
survival rate is approximately 60%, 52%, and 47% at 5 years, 10
years, and 20 years, respectively(7); however, recurrence is nearly
always fatal with no established standard of care.
The University of Texas is undertaking a Phase I
exploratory study in recurrent medulloblastoma patients using
direct administration of MTX110 into the fourth ventricle, enabling
it to circulate throughout the central spinal fluid.
PRECLINICAL ASSET
MTD217Our programme is centred around a
water-soluble drug formulation that can be easily infused or
injected simultaneously, or sequentially, directly into the cancer
microenvironment, disrupting metabolic functions in a highly
localised manner and limiting off-target toxicity. Our initial
target is treatment of leptomeningeal disease (“LMD”), a lethal
complication in which metastatic cancer cells invade the
cerebrospinal fluid and central nervous system. Approximately 5% of
all cancer patients develop LMD and, with no effective treatments
currently available, median overall survival is just three to six
months post- diagnosis(8).
(1) American Association of
Neurosurgeons
(2) Radke et al (2019). Predictive
MGMT status in a homogeneous cohort of IDH wildtype glioblastoma
patients. Acta Neuropathologica Communications 7:89 Online:
https://doi.org/10.1186/s40478-019-0745-z
(3) J Neurooncol. 2017; 135(1):
183–192
(4) Louis DN, Ellison DW, et al.
The 2016 World Health Organization Classification of Tumors of the
Central Nervous System: a summary. Acta Neuropathol 2016;
131:803–820
(5) Jansen et al, 2015.
Neuro-Oncology 17(1):160-166
(6) Aboian et al (2018).
Neuro-Oncology Practice, Volume 5, Issue 4, December 2018
(7) Smoll NR (March 2012).
"Relative survival of childhood and adult medulloblastomas and
primitive neuroectodermal tumors
(PNETs)". Cancer. 118 (5): 1313–22
(8)
https://my.clevelandclinic.org/health/diseases/22737-leptomeningeal-disease
CHIEF EXECUTIVE’S REVIEW
Introduction
With the backdrop of a continued difficult
market for financing biotech companies, 2023 was again dominated by
efforts to re-finance the Company and bring in additional
clinical-stage assets into the development pipeline to diversify
risk, enhance news flow and provide more opportunities for
success.
R&D Update
TolimidoneIn December 2023 we were delighted to
secure the global rights to develop and commercialise tolimidone.
It is not often a company of Biodexa’s size and resources has an
opportunity to in-license a Phase II ready product supported by
very substantial preclinical data, that has been exposed to more
than 700 patients and has demonstrated compelling preclinical data
to support our chosen indication of T1D.
In T1D, the body’s immune system attacks
pancreatic beta cells such that they can no longer produce insulin
which is required to regulate plasma glucose levels. The causes of
T1D are not fully understood and there is currently no cure.
Patients with T1D are dependent on daily administration of insulin
(via injection or infusion).
Tolimidone is a Lyn kinase activator and its
potential utility in T1D was first demonstrated by several
ground-breaking preclinical studies conducted at the University of
Alberta, where Lyn kinase was identified as a key factor for beta
cell survival and proliferation in in vitro and in vivo models.
Tolimidone was shown to both prevent beta cell degradation and to
stimulate beta cell proliferation.
As soon as we closed the in-license of
tolimidone we began preparing for a Phase IIa dose confirming study
which is expected to begin recruitment in the second quarter of
2024. The Phase IIa study will be open-label and include three
doses with approximately 15 patients studied over three months with
a follow up period. End points are expected to include C-peptide
levels (a marker for insulin), HbA1c levels (a marker for plasma
glucose) and number of severe hyperglycaemic events. Thereafter, we
expect to follow up by a double-blind, placebo-controlled Phase IIb
study in approximately 40-45 patients with similar clinical
endpoints.
MTX110In October 2023, we announced completion
of recruitment of Cohort A of our ongoing open-label Phase I
dose-escalation study which is designed to assess the feasibility
and safety of intermittent infusions of MTX110 administered by CED
via implanted refillable pump and catheter. Because no drug-related
adverse events were observed within the first 30 days from the
start of treatment, the minimum number of four patients were
recruited into Cohort A. Patient #1 received weekly infusions of
60µM of MTX110 and Patients # 2, 3 and 4 each received 90µM, the
expected optimum dose. The study site reported 12 months of
survival from the start of the treatment in the 1st patient (OS=12
months).
We initially began developing MTX110 for DMG,
the ultra-rare, highly aggressive and inoperable form of childhood
brain cancer. In February 2024 we announced the results of a Phase
I study conducted by Columbia University Irving Medical Center. As
this was the first ever study of repeated infusions to the pons via
an implanted CED catheter, the primary objective of the study was
safety and tolerability and, accordingly, the number of infusions
was limited to two, each of 48 hours, 7 days apart. Nine patients
were treated in the study (30 M group, n=3; 60 M group, n=4; 90 M
group (optimal dose), n=2). One patient in the 60 M group suffered
a severe adverse event assessed by the investigators as not related
to the study drug but related to the infusion and tumour anatomy.
Although the study was not powered to reliably demonstrate
efficacy, median overall survival (OS) of patients in the study was
16.5 months. We are also evaluating the utility of MTX110 in
medulloblastoma in a pilot study at the University of Texas.
MTD217During the year we initiated a new
preclinical programme, coded MTD217, to explore the simultaneous
inhibition of two key metabolic pathways used by cancer cells to
generate ATP. Blocking mitochondrial oxidative phosphorylation
limits metabolic plasticity that enables cancer cells to adapt and
survive. Our initial target for MTD217 is treatment of
Leptomeningeal Disease, a lethal complication in which metastatic
cancer cells invade the cerebrospinal fluid and central nervous
system. In collaboration with a CRO, we developed a Leptomeningeal
Disease in vivo model and awaiting results.
Financings
Private Placement, February 2023On 15 February
2023 we raised $6.0 million before expenses through a Private
Placement in the US of 3,250,200 Ordinary Shares (8,125 ADSs) and
62,184,525 Pre-funded Warrants (155,461 ADSs). We also issued to
investors Series A Warrants exercisable into 12,931,200 Ordinary
Shares (32,327 ADSs) and Series B Warrants exercisable into
19,396,400 Ordinary Shares (48,491 ADSs). We also issued Series A
Warrants exercisable into 625,000 Ordinary Shares (1,562 ADSs) to a
former investor in return for a waiver from an obligation under a
prior financing. All of the Series A and Series B Warrants have
been exercised.
Registered Direct Offering, May 2023On 26 May
2023 we raised $3.3 million before expenses via a Registered Direct
Offering in the US of 110,679,610 Ordinary Shares (279,999 ADSs).
We also issued to investors Series C Warrants exercisable into
166,017,700 Ordinary Shares (415,044 ADSs) and Series D Warrants
exercisable into 110,679,610 Ordinary Shares (279,699 ADSs). All of
the Series C Warrants have been exercised. None of the Series D
Warrants, exercisable at $16.00 per ADS, have been exercised. The
Series D Warrants may be exercised at any time until May 2028.
Registered Offering, December 2023In connection
with Assignment and Exchange Agreement with Adhera Therapeutics,
Inc and the in-license from Melior Pharmaceuticals I, Inc. of
tolimidone, on 21 December 2023 we raised $6.0 million in an F-1
offering in the US of 435,544,800 Ordinary Shares (1,088,887 ADSs)
and 1,911,176 Pre-funded Warrants (764,470,400 Ordinary Shares). We
also issued to investors Series E Warrants exercisable into
1,200,025,200 Ordinary Shares (3,000,063 ADSs) and Series F
Warrants exercisable into 1,200,025,200 Ordinary Shares (3,000,063
ADSs). None of the Series E Warrants or the Series F Warrants have
been exercised. The Series E Warrants and the Series F Warrants are
exercisable at $2.20 per ADS and expire in December 2024 and
December 2028, respectively. In addition, because the Adhera
Secured Noteholders, as a group, subscribed for $4.0 million in
total of Class A and Class B Units in the offering, we paid a
further $0.4 million in cash to Adhera and issued a further $3.0
million of our ADSs, valued at the Class A Offering Price, to the
Adhera Secured Noteholders. This resulted in the issue of
49,836,400 ordinary shares (328,000 ADSs) and 550,163,200
pre-funded warrant ordinary shares (1,375,408 pre-funded warrant
ADSs).
De-listing from AIM
Following shareholder approval at a General
meeting on 24 March 2023, the Company was de-listed from the AIM
market with effect from 26 April 2023. The Board decided to
recommend cancelling the Company’s AIM listing for a number of
reasons including: an increasingly smaller proportion of trading in
the Ordinary Shares is conducted on AIM compared to NASDAQ ;
improved liquidity through concentration of trading in the
Company’s securities on a single market; and, the cost, management
time commitment and the burden of complying with the AIM Rules and
maintaining a quotation on AIM is duplicative of that for complying
with the NASDAQ rules. In addition, as was demonstrated with the
in-licensing of tolimidone, we intend to seek opportunities to
expand our pipeline through the acquisition and / or in-licensing
of additional development programmes. Given our market
capitalisation, most transactions are likely to be deemed reverse
takeovers under AIM rules, requiring suspension and re-listing via
a new Admission Document which is both time-consuming and
costly.
Change of Name
Our intention is that re-positioning as a
therapeutics company should represent a “fresh start” for the
Company. To reflect this change the Company’s name was changed to
Biodexa Pharmaceuticals PLC following a General Meeting on 24 March
2023.
Outlook
Taking into account the $15.3 million (gross) we
raised in 2023, we have the resources to deliver two sets of
preclinical data and three sets of clinical data in 2024. Our
development pipeline now includes five programs, of which four are
at clinical stage. With the pipeline stronger than it has ever
been, we are enthusiastic about the potential for our Company in
2024 and beyond.
FINANCIAL REVIEW
Introduction
Biodexa Pharmaceuticals PLC (the "Company") was
incorporated as a company on 12 September 2014 and is domiciled in
England and Wales.
Financial analysis
Key performance indicators
|
2023 |
2022 |
Change |
|
|
|
|
Total gross revenue(1) |
£0.38m |
£0.70m |
(46)% |
R&D expenditure |
£4.07m |
£5.11m |
(20)% |
R&D as % of operating costs |
48% |
53% |
n/a |
Net cash inflow/(outflow) for the year |
£3.14m |
(£7.22m) |
n/m |
|
============ |
============ |
============ |
|
|
|
|
(1) |
Total gross revenue represents collaboration income. |
Revenue
In the year ended 31 December 2023, Biodexa
generated consolidated total gross revenue of £0.38m (2022:
£0.70m), a decrease of 46% on the prior year, this arose from
customer revenue as in 2022. Customer revenue was derived entirely
from the Group’s R&D collaboration agreements with Janssen in
both years which has now ceased.
Research and development expenditure
Research and development costs were £4.07m, a
reduction of £1.04m, or 20% on 2022 (2022: £5.11m). The percentage
of R&D costs as a percentage of operating costs also reduced to
48% from 53% in the prior year. The reduction in the year reflects
the Directors decision to reposition as a therapeutics company and
to not expand our internal drug delivery platform, resulting in a
reduction in pre-clinical expense of £0.87m. Personnel costs also
reduced by £0.39m as a result of the cost reduction program in
March 2023 where eight staff members were made redundant at a
one-time cost of £105k. Expenditure on the MTX110 clinical program
increased during the year by £0.41m offsetting in part the reduced
expense on pre-clinical programs and staffing.
Administrative costs
Administrative costs in the year reduced by
£0.2m to £4.34m (2022: £4.54m). During the year the Company
expensed £1.31m on legal and professional fees in connection with
the successful financing transactions in the year, the acquisition
of the tolimidone licence in December 2023 and aborted
acquisitions, this compares to £1.36m spent in 2022 on the aborted
acquisition of Bioasis Technologies Inc (“Bioasis”). During the
year the Company provided a loan to Adhera Therapeutics, Inc.
(“Adhera”) of £0.08m, which was forgiven on completion of the
acquisition of the global rights to develop and commercialise
tolimidone in December 2023 transaction.
Staff costs
During the year, the average number of staff
decreased to decreased to 21 (2022: 27), reflecting the cost
reduction program undertaken in March 2023. Total staff cost
reduced 19% to £2.06m (2022: £2.52m).
Taxation
During 2023 and 2022 we recognized U.K research and
development tax credits of £0.41m and £0.83m in respect of R&D
expenditure incurred. The lower tax credit in the current year is
due to the reduced R&D spend compared to 2022.
Capital expenditure
Purchase of tangible fixed assets in 2023 was
£0.03m (2022: £0.06m) and related to investment in laboratory
equipment. In addition, in December 2023, the Company purchased an
intangible asset being the global rights to develop and
commercialise tolimidone for total consideration of £2.94m, this
was satisfied £0.24m in cash and £2.70m by the issue of ordinary
shares and pre-funded warrants.
Cash flow
Net cash outflow from operating activities in
2023 was £6.83m (2022: outflow £7.05m) driven by a net loss of
£7.08 (2022: loss £7.66m) and after negative movements in working
capital of £0.05m (2022: positive £0.52m), taxes received of £0.84m
(2022: £0.68m), and other net negative adjustments for non-cash
items totalling £0.54m (2022: negative £0.59m).
Investing activities outflow in 2023 of £0.27m
(2022: outflow of £0.22m) included purchases of property, plant and
equipment of £0.03m (2022: £0.06m), purchase of tolimidone licence
for total consideration of £2.94m including cash of £0.24m. These
cash outflows are offset interest income from bank deposits of
£0.07m (2022: £0.03m).
Financing activities inflow in 2023 of £10.23m
(2021: inflow of £0.05m) was driven by receipts from share issues
of £10.43m (2022: £0.24m). The other principal outflows related
interest paid of £0.01m (2022: £0.02m) and payments on lease
liabilities of £0.19m (2022: £0.18m).
As a result of the foregoing, net cash inflow
for the year was £3.14m (2022: outflow of £7.22 m).
Share consolidation and ADS
Ratio
At a General Meeting on 24 March 2023,
shareholders approved a consolidation of the Company’s Ordinary
Shares on a one for 20 basis. As a result the par value of the
Ordinary Shares was changed from £0.001 per share to £0.02 per
share. At the same time, the ratio of the Company’s Ordinary Shares
to ADSs was changed from each ADS representing 25 Ordinary Shares
to each ADS representing 5 Ordinary Shares.
At a General Meeting on 14 June 2023,
shareholders approved the subdivision and redesignation of the
Company’s Issued Ordinary Shares of £0.02 each into to one Ordinary
Share of £0.001 each and 19 ‘B’ Deferred Shares of £0.001 each. The
‘B’ Deferred Shares have limited rights and are effectively
valueless.
On 5 July 2023 the Company affected a change in
the ratio of the Company’s Ordinary Shares from each ADS
representing 5 Ordinary Shares to each ADS representing 400
Ordinary Shares.
Going Concern – material
uncertainty
The Group and Company has experienced net losses
and significant cash outflows from cash used in operating
activities over the past years as it develops its portfolio. For
the year ended 31 December 2023, the Group incurred a consolidated
loss for the year of £7.08m and negative cash flows from operations
of £6.83m. As of 31 December, 2023, the Group had an accumulated
deficit of £142.82 m.
The Group’s future viability is dependent on its
ability to raise cash from financing activities to finance its
development plans until milestones and/or royalties can be secured
from partnering the Company’s assets. The Group’s failure to raise
capital as and when needed could have a negative impact on its
financial condition and ability to pursue its business
strategies.
The Directors believe there are adequate options
and time available to secure additional financing for the Company
and after considering the uncertainties, the Directors consider it
is appropriate to continue to adopt the going concern basis in
preparing these financial statements. The Group's consolidated
financial statements have therefore been presented on a going
concern basis, which contemplates the realization of assets and the
satisfaction of liabilities in the normal course of business.
As at 31 December 2023, the Group had cash and
cash equivalents of £5.97m. The Directors have prepared cash flow
forecasts and considered the cash flow requirement for the Group
for the next three years including the period 12 months from the
date of approval of the consolidated financial statements. These
forecasts show that further financing will be required before the
fourth quarter of 2024 assuming, inter alia, that certain
development programs and other operating activities continue as
currently planned. If the Company does not secure additional
funding before the fourth quarter of 2024, it will no longer be a
going concern and would likely be placed in Administration.
Our forecast of the period of time through which
our financial resources will be adequate to support our operations
is a forward-looking statement and involves risks and
uncertainties, and actual results could vary as a result of a
number of factors, including the timing of clinical trials. We have
based this estimate on assumptions that may prove to be wrong, and
we could utilize our available capital resources sooner than we
currently expect. If we lack sufficient capital to expand our
operations or otherwise capitalize on our business opportunities,
our business, financial condition and results of operations could
be materially adversely affected.
If we raise additional funds through the
issuance of debt securities or additional equity securities, it
could result in dilution to our existing shareholders, increased
fixed payment obligations and these securities may have rights
senior to those of our ordinary shares (including the ADSs) and
could contain covenants that would restrict our operations and
potentially impair our competitiveness, such as limitations on our
ability to incur additional debt, limitations on our ability to
acquire, sell or license intellectual property rights and other
operating restrictions that could adversely impact our ability to
conduct our business. Any of these events could significantly harm
our business, financial condition and prospects.
In the Directors’ opinion, the environment for
financing of small and micro-cap biotech companies remains
challenging. While this may present acquisition and/or merger
opportunities with other companies with limited or no access to
financing, as noted above, any attendant financings by Biodexa are
likely to be dilutive. The Directors continue to evaluate financing
options, including those connected to acquisitions and/or mergers,
potentially available to the Group. Any alternatives considered are
contingent upon the agreement of counterparties and accordingly,
there can be no assurance that any alternative courses of action to
finance the Company would be successful.
This requirement for additional financing in the
short term represents a material uncertainty that may cast
significant doubt upon the Group and Parent Company’s ability to
continue as a going concern. Should it become evident in the future
that there are no realistic financing options available to the
Company which are actionable before its cash resources run out then
the Company will no longer be a going concern. In such
circumstances, we would no longer be able to prepare financial
statements under paragraph 25 of IAS 1. Instead, the financial
statements would be prepared on a liquidation basis and assets
would be stated at net realizable value and all liabilities would
be accelerated to current liabilities.
Macro-economic environment
The invasion by the Russian Federation military
in Ukraine in early 2022 and the recent Israeli/Palestinian
conflict in the Middle East has had a destabilising impact on the
global economy. Although there has been no immediate impact on the
Group, it is not possible to assess the medium- and long-term
impact of these conflicts on the Group and the global economy
generally.Environmental matters, community, human rights
issues and employees
As at 31 December 2023 the Group had 16
employees, of whom 10 were routinely based at its offices in
Cardiff, Accordingly the Company believes it has a relatively
modest environmental impact. All materials imported into the
Company’s laboratories are assessed for safety purposes and
appropriate handling and storage safeguards imposed as necessary.
Any small quantities of hazardous materials are removed by licensed
waste management contractors. A number of policies and procedures
governing expectations of ethical standards and the treatment of
employees and other stakeholders are set out in the Company’s
Employee Handbook. The Company has also established an anti-slavery
policy pursuant to the Modern Slavery Act 2015.
The Company strives to be an equal opportunity
employer, irrespective of race or gender. At 31 December 2023, the
number of male/female employees was 31%/69%, the number of
male/female senior managers was 67%/33% and the number of
male/female Directors was 80%/20%.
Annual greenhouse gas
emissions
We measure our environmental performance by
reporting our carbon footprint in terms of tonne CO2 equivalent. We
report separately on our indirect emissions from consumption of
electricity (Scope 2) and emissions consisting of employee travel
in cars on Group business estimated on the basis of miles travelled
(Scope 3). The Group have elected to monitor and report its energy
efficiency using tonnes of CO2 per employee as an intensity
ratio.
Methodology
In calculating the reported energy usage and
equivalent greenhouse gas emissions the Group have referred to the
HM Government Environment Reporting Guidelines and the GHG
Reporting Protocol. A location-based allocation methodology was
used to calculate electricity usage.
Tonnes CO2e |
2023 |
2022 |
Scope 2 |
18 |
15 |
Scope 3 |
3 |
3 |
Total |
21 |
18 |
Intensity ratio (tonnes of CO2
per employee) |
1.0 |
0.7 |
|
|
|
The Group’s electricity costs for 2023 were
approximately £30,000 (2022: £23,000). The kWh usage in the year
was 87,780 (2022: 78,017). The Group has no immediate plans to
improve energy efficiency.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE
INCOME
For the year ended 31 December
|
Note |
2023£’000 |
2022£’000 |
2021£’000 |
Revenue |
|
381 |
699 |
578 |
Other income |
|
14 |
22 |
24 |
Research and development costs |
|
(4,067) |
(5,111) |
(4,654) |
Administrative costs |
|
(4,342) |
(4,542) |
(2,946) |
Loss from operations |
|
(8,014) |
(8,932) |
(6,998) |
Finance income |
2 |
570 |
497 |
936 |
Finance expense |
2 |
(41) |
(53) |
(44) |
Loss before tax |
|
(7,485) |
(8,488) |
(6,106) |
Taxation |
3 |
406 |
832 |
646 |
Loss for the year attributable to the owners of the
parent |
|
(7,079) |
(7,656) |
(5,460) |
Other comprehensive income: |
|
|
|
|
Items that will or may be reclassified subsequently to profit or
loss: |
|
|
|
|
Total other comprehensive income net of tax |
|
– |
– |
– |
Total comprehensive loss attributable to the owners of the
parent |
|
(7,079) |
(7,656) |
(5,460) |
Loss per share |
|
|
|
|
Continuing operations |
|
|
|
|
Basic and diluted loss per ordinary share - pence |
4 |
(2)p |
(155) p |
(136) p |
The notes form an integral part of these
consolidated financial statements.
CONSOLIDATED STATEMENTS OF FINANCIAL
POSITION
At 31 December
Company number 09216368 |
Note |
2023£’000 |
2022£’000 |
2021£’000 |
Assets |
|
|
|
|
Non-current assets |
|
|
|
|
Property, plant and equipment |
|
571 |
831 |
1,152 |
Intangible assets |
5 |
2,941 |
6 |
– |
|
|
3,512 |
837 |
1,152 |
Current assets |
|
|
|
|
Trade and other receivables |
|
637 |
1,006 |
1,034 |
Current taxation receivable |
|
422 |
846 |
670 |
Cash and cash equivalents |
|
5,971 |
2,836 |
10,057 |
|
|
7,030 |
4,688 |
11,761 |
Total assets |
|
10,542 |
5,525 |
12,913 |
Liabilities |
|
|
|
|
Non-current liabilities |
|
|
|
|
Borrowings |
6 |
295 |
463 |
620 |
|
|
295 |
463 |
620 |
Current liabilities |
|
|
|
|
Trade and other payables |
|
1,240 |
1,447 |
1,092 |
Borrowings |
6 |
169 |
161 |
146 |
Provisions |
7 |
– |
207 |
50 |
Derivative financial liability |
8 |
4,160 |
85 |
553 |
|
|
5,569 |
1,900 |
1,841 |
Total liabilities |
|
5,864 |
2,363 |
2,461 |
CONSOLIDATED STATEMENTS OF FINANCIAL
POSITION(CONTINUED)At 31
December |
|
Note |
2023£’000 |
2022£’000 |
2021£’000 |
Issued capital and reserves attributable to owners of the
parent |
|
|
|
|
Share capital |
9 |
6,253 |
1,108 |
1,098 |
Share premium |
|
86,732 |
83,667 |
83,434 |
Merger reserve |
|
53,003 |
53,003 |
53,003 |
Warrant reserve |
|
3,457 |
720 |
720 |
Accumulated deficit |
|
(144,767) |
(135,336) |
(127,803) |
Total equity |
|
4,678 |
3,162 |
10,452 |
Total equity and liabilities |
|
10,542 |
5,525 |
12,913 |
CONSOLIDATED STATEMENTS OF CASH
FLOWS
For the year ended 31 December
|
Note |
2023£’000 |
2022£’000 |
2021£’000 |
Cash flows from operating activities |
|
|
|
|
Loss for the year |
|
(7,079) |
(7,656) |
(5,460) |
Adjustments for: |
|
|
|
|
Depreciation of property, plant and equipment |
|
143 |
174 |
213 |
Depreciation of right of use asset |
|
137 |
166 |
190 |
Amortisation of intangible fixed assets |
5 |
3 |
3 |
– |
Loss/(Profit) on disposal of property, plant and equipment |
|
2 |
14 |
(39) |
Impairment of loan |
|
79 |
207 |
– |
Finance income |
2 |
(570) |
(497) |
(936) |
Finance expense |
2 |
41 |
53 |
44 |
Share-based payment charge |
|
28 |
123 |
89 |
Taxation |
3 |
(406) |
(832) |
(646) |
Foreign exchange gains |
|
– |
(1) |
(3) |
Cash flows from operating activities before changes in
working capital |
|
(7,622) |
(8,246) |
(6,548) |
Decrease/(Increase) in trade and other receivables |
|
365 |
7 |
(487) |
(Decrease)/Increase in trade and other payables |
|
(207) |
356 |
(130) |
(Decrease)/Increase in provisions |
7 |
(207) |
157 |
– |
Cash used in operations |
|
(7,671) |
(7,726) |
(7,165) |
Taxes received |
|
845 |
678 |
1,157 |
Net cash used in operating activities |
|
(6,826) |
(7,048) |
(6,008) |
CONSOLIDATED STATEMENTS OF CASH
FLOWS(CONTINUED)
For the year ended 31 December
|
Note |
2023£’000 |
2022£’000 |
2021£’000 |
Investing activities |
|
|
|
|
Purchases of property, plant and equipment |
|
(26) |
(62) |
(320) |
Proceeds from disposal of fixed assets |
|
4 |
20 |
42 |
Purchase intangible asset |
5 |
(237) |
– |
– |
Loan granted |
|
(79) |
(207) |
– |
Interest received |
|
73 |
29 |
– |
Net cash (used in)/generated from investing
activities |
|
(265) |
(220) |
(278) |
Financing activities |
|
|
|
|
Interest paid |
|
(13) |
(18) |
(15) |
Amounts paid on lease liabilities |
|
(188) |
(178) |
(112) |
Repayment from Government loan |
|
– |
– |
(103) |
Share issues including warrants, net of costs |
|
10,427 |
243 |
9,035 |
Net cash generated from financing activities |
|
10,226 |
47 |
8,805 |
Net increase/(decrease) in cash and cash
equivalents |
|
3,135 |
(7,221) |
2,519 |
Cash and cash equivalents at beginning of
year |
|
2,836 |
10,057 |
7,546 |
Exchange (losses)/gains on cash and cash equivalents |
|
– |
– |
(8) |
Cash and cash equivalents at end of year |
|
5,971 |
2,836 |
10,057 |
CONSOLIDATED STATEMENTS OF CHANGES IN
EQUITY
For the year ended 31 December
|
Note |
Sharecapital£’000 |
Sharepremium£’000 |
Merger reserve£’000 |
Warrant reserve £’000 |
Accumulateddeficit£’000 |
Totalequity£’000 |
At 1 January 2023 |
|
1,108 |
83,667 |
53,003 |
720 |
(135,336) |
3,162 |
Loss for the year |
|
– |
– |
– |
– |
(7,079) |
(7,079) |
Total comprehensive loss |
|
– |
– |
– |
– |
(7,079) |
(7,079) |
Transactions with owners |
|
|
|
|
|
|
|
Shares issued on 15 February 2023 |
9 |
1,956 |
3,013 |
– |
– |
– |
4,969 |
Costs associated with share issue on 15 February 2023 |
9 |
– |
(903) |
– |
– |
– |
(903) |
Shares issued on 26 May 2023 |
9 |
2,380 |
|
– |
|
(355) |
2,025 |
Costs associated with share issue on 26 May 2023 |
9 |
– |
– |
– |
|
(527) |
(527) |
Shares issued on 21 December 2023 |
9 |
485 |
– |
– |
1,315 |
(1,273) |
527 |
Costs associated with share issue on 21 December 2023 |
9 |
– |
– |
– |
– |
(441) |
(441) |
Issue of shares to purchase intangible asset |
5 |
324 |
955 |
– |
1,422 |
– |
2,701 |
Share-based payment charge |
|
– |
– |
– |
– |
244 |
244 |
Total contribution by and distributions to
owners |
|
5,145 |
3,065 |
– |
2,737 |
(2,352) |
8,595 |
At 31 December 2023 |
|
6,253 |
86,732 |
53,003 |
3,457 |
(144,767) |
4,678 |
CONSOLIDATED STATEMENTS OF CHANGES IN
EQUITY(CONTINUED)
|
Note |
Sharecapital£’000 |
Sharepremium£’000 |
Merger reserve£’000 |
Warrant reserve £’000 |
Accumulateddeficit£’000 |
Totalequity£’000 |
At 1 January 2022 |
|
1,098 |
83,434 |
53,003 |
720 |
(127,803) |
10,452 |
Loss for the year |
|
– |
– |
– |
– |
(7,656) |
(7,656) |
Total comprehensive loss |
|
– |
– |
– |
– |
(7,656) |
(7,656) |
Transactions with owners |
|
|
|
|
|
|
|
Exercise of warrants on 22 March 2022 |
14,21 |
– |
– |
– |
– |
– |
– |
Shares issued on 19 December 2022 |
14,21 |
10 |
311 |
– |
– |
– |
321 |
Costs associated with share issue on 19 December 2022 |
14,21 |
– |
(78) |
– |
– |
– |
(78) |
Share-based payment charge |
|
– |
– |
– |
– |
123 |
123 |
Total contribution by and distributions to
owners |
|
10 |
233 |
– |
– |
123 |
366 |
At 31 December 2022 |
|
1,108 |
83,667 |
53,003 |
720 |
(135,336) |
3,162 |
NOTES FORMING PART OF THE FINANCIAL
STATEMENTS
For the year ended 31 December
2023
- Basis of
preparation
The consolidated financial statements have been
prepared in accordance with international accounting standards in
conformity with the requirements of the Companies Act 2006, and
they are prepared in accordance with international financial
reporting standards. The consolidated financial statements have
been prepared on a historical cost basis except that the following
assets and liabilities are stated at their fair value: certain
financial assets and financial liabilities measured at fair value,
and liabilities for cash-settled share-based payments.
The financial information contained in this
final announcement does not constitute statutory financial
statements as defined in Section 435 of the Companies Act 2006. The
financial information has been extracted from the financial
statements for the year ended 31 December 2023 which have been
approved by the Board of Directors, and the comparative figures for
the year ended 31 December 2022 and 31 December 2021 are based on
the financial statements for that year.
The financial statements for 2022 and 2021 have
been delivered to the Registrar of Companies and the 2023 financial
statements will be delivered after the Annual General Meeting.
The auditor’s report for the Company’s 2023
Annual Report and Accounts was unqualified but did draw attention
to the material uncertainty relating to going concern. The
auditor’s report did not contain statements under s498(2) or (3) of
the Companies Act 2006.
Whilst the financial information included in
this results announcement has been prepared in accordance with
International Financial Reporting Standards (IFRSs) this
announcement does not itself contain sufficient information to
comply with IFRSs. The information in this results announcement was
approved by the board on • April 2024.
Going concern – material
uncertainty
The Group and Company has experienced net losses
and significant cash outflows from cash used in operating
activities over the past years as it develops its portfolio. For
the year ended 31 December 2023, the Group incurred a consolidated
loss for the year of £7.08m and negative cash flows from operating
activities of £6.83m. As of 31 December 2023, the Group had an
accumulated deficit of £142.82m.
The Group’s future viability is dependent on its
ability to raise cash from financing activities to finance its
development plans until milestones and/or royalties can be secured
from partnering the Company’s assets. The Group’s failure to raise
capital as and when needed could have a negative impact on its
financial condition and ability to pursue its business
strategies.
The Directors believe there are adequate options
and time available to secure additional financing for the Company
and after considering the uncertainties, the Directors consider it
is appropriate to continue to adopt the going concern basis in
preparing these financial statements. The Group's consolidated
financial statements have therefore been presented on a going
concern basis, which contemplates the realization of assets and the
satisfaction of liabilities in the normal course of business.
As at 31 December 2023, the Group had cash and
cash equivalents of £5.97m. The Directors have prepared cash flow
forecasts and considered the cash flow requirement for the Group
for the next three years including the period 12 months from the
date of approval of the consolidated financial statements. These
forecasts show that further financing will be required before the
fourth quarter of 2024 assuming, inter alia, that certain
development programs and other operating activities continue as
currently planned. If the Company does not secure additional
funding before the fourth quarter of 2024, it will no longer be a
going concern and would likely be placed in Administration.
Our forecast of the period of time through which
our financial resources will be adequate to support our operations
is a forward-looking statement and involves risks and
uncertainties, and actual results could vary as a result of a
number of factors, including the timing of clinical trials. We have
based this estimate on assumptions that may prove to be wrong, and
we could utilize our available capital resources sooner than we
currently expect. If we lack sufficient capital to expand our
operations or otherwise capitalize on our business opportunities,
our business, financial condition and results of operations could
be materially adversely affected.
If we raise additional funds through the
issuance of debt securities or additional equity securities, it
could result in dilution to our existing shareholders, increased
fixed payment obligations and these securities may have rights
senior to those of our ordinary shares (including the ADSs) and
could contain covenants that would restrict our operations and
potentially impair our competitiveness, such as limitations on our
ability to incur additional debt, limitations on our ability to
acquire, sell or license intellectual property rights and other
operating restrictions that could adversely impact our ability to
conduct our business. Any of these events could significantly harm
our business, financial condition and prospects.
In the Directors’ opinion, the environment for
financing of small and micro-cap biotech companies remains
challenging. While this may present acquisition and/or merger
opportunities with other companies with limited or no access to
financing, as noted above, any attendant financings by Biodexa are
likely to be dilutive. The Directors continue to evaluate financing
options, including those connected to acquisitions and/or mergers,
potentially available to the Group. Any alternatives considered are
contingent upon the agreement of counterparties and accordingly,
there can be no assurance that any alternative courses of action to
finance the Company would be successful.
This requirement for additional financing in the
short term represents a material uncertainty that may cast
significant doubt upon the Group and Parent Company’s ability to
continue as a going concern. Should it become evident in the future
that there are no realistic financing options available to the
Company which are actionable before its cash resources run out then
the Company will no longer be a going concern. In such
circumstances, we would no longer be able to prepare financial
statements under paragraph 25 of IAS 1. Instead, the financial
statements would be prepared on a liquidation basis and assets
would be stated at net realizable value and all liabilities would
be accelerated to current liabilities.
2 Finance
income and expense
|
2023£’000 |
2022£’000 |
2021£’000 |
Finance income |
|
|
|
Interest received on bank deposits |
73 |
29 |
– |
Other interest receivable |
10 |
– |
– |
Gain on equity settled derivative financial liability |
487 |
468 |
936 |
Total finance income |
570 |
497 |
936 |
|
2023£’000 |
2022£’000 |
2021£’000 |
Finance expense |
|
|
|
Interest expense on lease liabilities |
28 |
43 |
36 |
Other loans |
13 |
10 |
8 |
Total finance expense |
41 |
53 |
44 |
The gain on the equity settled derivative financial
liability in 2023, 2022 and 2021 arose as a result of the movement
in share price.
3
Taxation
|
2023£’000 |
2022£’000 |
2021£’000 |
Current tax credit |
|
|
|
Current tax credited to the income statement |
407 |
825 |
646 |
Adjustment in respect of prior year |
(1) |
7 |
– |
|
406 |
832 |
646 |
Deferred tax credit |
|
|
|
Reversal of temporary differences |
– |
– |
– |
Total tax credit |
406 |
832 |
646 |
The reasons for the difference between the actual
tax charge for the year and the standard rate of corporation tax in
the United Kingdom applied to losses for the year are as
follows:
|
2023£’000 |
2022£’000 |
2021£’000 |
Loss before tax |
(7,485) |
(8,488) |
(6,106) |
Expected tax credit based on the standard rate of United Kingdom
corporation tax at the domestic rate of 23.52% (2021: 19%; 2020:
19%) |
(1,764) |
(1,613) |
(1,160) |
Expenses not deductible for tax purposes |
408 |
392 |
75 |
Income not taxable |
(5) |
(4) |
(2) |
Adjustment in respect of prior period |
1 |
(7) |
– |
Effect of R&D relief |
26 |
(357) |
(280) |
Deferred tax not recognised |
928 |
757 |
721 |
Total tax credited to the income statement |
(406) |
(832) |
(646) |
The taxation credit arises on the enhanced research
and development tax credits accrued for the respective periods.
4 Loss
per share
|
2023£’000 |
2022£’000 |
2021£’000 |
Numerator |
|
|
|
Loss used in basic EPS and diluted EPS: |
|
|
|
Continuing operations |
(7,079) |
(7,656) |
(5,460) |
Denominator |
|
|
|
Weighted average number of ordinary shares used in basic EPS: |
315,849,600 |
4,941,793 |
4,027,345 |
Basic and diluted loss per share: |
|
|
|
Continuing operations – pence |
(2)p |
(155) p |
(136) p |
At a General Meeting on 24 March 2023,
shareholders approved a consolidation of the Company’s Ordinary
Shares on a one for 20 basis. As a result, the par value of the
Ordinary Shares was changed from £0.001 per share to £0.02 per
share. The denominator has been calculated to reflect the share
consolidation in the current and prior periods.
At a General Meeting on 14 June 2023,
shareholders approved the subdivision and redesignation of the
Company’s Issued Ordinary Shares of £0.02 each into to one Ordinary
Share of £0.001 each and 19 ‘B’ Deferred Shares of £0.001 each. The
‘B’ Deferred Shares have limited rights and are effectively
valueless. The share sub-division and redesignation did not impact
the calculation of the denominator as the number of Issued Ordinary
Shares did not change.
During the year the Company issued warrants that
were accounted through the Warrant Reserve as detailed in note
9.
The Company has considered the guidance set out
in IAS 33 in calculating the denominator in connection with the
issuance of Pre-Funded, Series A, Series B and Series C warrants as
disclosed in note 9. Management have recognised the warrants from
the date of grant rather than the date of issue of the
corresponding Ordinary Shares when calculating the denominator.
The Group has made a loss in the current and
previous periods presented, and therefore the options and warrants
are anti-dilutive. As a result, diluted earnings per share is
presented on the same basis as basic earning per share.
5 Intangible
assets
|
In-process research and
development£’000 |
Goodwill£’000 |
IT/Website costs£’000 |
Total£’000 |
Cost |
|
|
|
|
At 1 January 2021 |
13,378 |
2,291 |
– |
15,669 |
At 31 December 2021 |
13,378 |
2,291 |
– |
15,669 |
Transfer from property, plant and equipment |
– |
– |
122 |
122 |
Disposal |
– |
– |
(12) |
(12) |
At 31 December 2022 |
13,378 |
2,291 |
110 |
15,779 |
Acquisition |
2,938 |
– |
– |
2,938 |
At 31 December 2023 |
16,316 |
2,291 |
110 |
18,717 |
|
In-processresearch
anddevelopment£’000 |
Goodwill£’000 |
IT/WebsiteCosts£’000 |
Total£’000 |
Accumulated amortisation and impairment |
|
|
|
|
At 1 January 2021 |
13,378 |
2,291 |
– |
15,669 |
At 31 December 2021 |
13,378 |
2,291 |
– |
15,669 |
Amortisation charge for the year |
– |
– |
3 |
3 |
Transfer from property, plant and equipment |
– |
– |
113 |
113 |
Disposal |
– |
– |
(12) |
(12) |
At 31 December 2022 |
13,378 |
2,291 |
104 |
15,773 |
Amortisation charge for the year |
– |
– |
3 |
3 |
Disposal |
– |
– |
– |
– |
At 31 December 2023 |
13,378 |
2,291 |
107 |
15,776 |
Net book value |
|
|
|
|
At 31 December 2023 |
2,938 |
– |
3 |
2,941 |
At 31 December 2022 |
– |
– |
6 |
6 |
At 31 December 2021 |
– |
– |
– |
– |
The individual intangible asset which is material
to the financial statements is as follows:
|
Carrying amount |
Remaining amortisation period |
2023£’000 |
2022£’000 |
2021 £’000 |
2023(years) |
2022(years) |
2021(years) |
MTX228 tolimidone acquired IPRD* |
2,938 |
– |
– |
n/a |
n/a |
n/a |
*asset is not yet in use and has not started
amortising
On 21 December 2023 the Company executed an
Assignment and Exchange Agreement with Adhera for assignment of
Adhera’s rights and a new licence for tolimidone (MTX228) with
Melior for total consideration of $11.12million. The initial
consideration was settled as follows:
|
$’000 |
£’000 |
Cash paid to Adhera |
300 |
237 |
100,356 ADSs, valued at the Offer price issued to Adhera Loan
Noteholders |
201 |
159 |
899,642 Pre-funded warrants at the Offering price issued to Adhera
Loan Noteholders |
1,799 |
1,422 |
708,856 ADSs at the Offer price issued to Melior |
1,418 |
1,120 |
Recognised as intangible asset purchase |
3,718 |
2,938 |
In addition, conditional upon Adhera Loan
Noteholders subscribing for not less than $4 million in the
Registered Offering the company paid a further $0.4million in cash
and as an adjustment to equity of $3.0million satisfied by the
issue of 124,591 ADSs and 1,375,408 pre-funded warrants and not as
consideration for the acquisition of the intangible asset. These
have been accounted for within the December 2023 Registered
Offering
The Assignment and Exchange Agreement also
provides for deferred consideration totalling $4.0 million payable
upon in part upon the completion of a positive Phase II clinical
study of Tolimidone in Type-1 diabetes and in part upon the first
commercial sale of tolimidone. In addition, the Company is
obligated to pay single digit tiered royalties on net sales of
tolimidone to Melior.
The ADSs issued under the transaction are
subject to restrictions on their resale.
The Group reviews the carrying amounts of its
intangible assets to determine whether there are any indications
that those assets have suffered an impairment loss. If any such
indications exist, the recoverable amount of the asset is estimated
in order to determine the extent of the impairment loss. Impairment
indications include events causing significant changes in any of
the underlying assumptions used in the income approach utilised in
valuing in process R&D. The key assumptions are : estimation of
future cash flows which is dependent on the probability of success,
the discount factor, the timing of future revenue flows, market
penetration and peak sales assumptions, and expenditure required to
complete development, estimation of the long-term rate of growth
for the business, estimation of the useful life over which cash
flows will occur and determination of our weighted-average cost of
capital.
6 Borrowings
|
2023£’000 |
2022£’000 |
2021£’000 |
Current |
|
|
|
Lease liabilities |
169 |
161 |
146 |
Total |
169 |
161 |
146 |
Non-current |
|
|
|
Lease liabilities |
295 |
463 |
620 |
Total |
295 |
463 |
620 |
Book values approximate to fair value at 31
December 2023, 2022 and 2021.
Obligations under finance leases are secured by a
fixed charge over the fixed assets to which they relate.
Government loans in Spain
During 2021 a euro denominated government and
research loan of £103k was repaid. This amount translated at year
end rate was £107k. The loan was repaid in February 2021 prior to
the liquidation of MPE.
7 Provisions
|
2023£’000 |
2022£’000 |
2021£’000 |
Opening provision at 1 January |
207 |
50 |
50 |
Utilisation of provision |
(207) |
(43) |
– |
Provision recognised in the year |
– |
200 |
– |
At 31 December |
– |
207 |
50 |
Less: non-current portion |
– |
– |
– |
Current portion |
– |
207 |
50 |
The provision as at 31 December 2021 represents
management’s best estimate of the ‘making good’ clause on the
Cardiff office which was vacated during the fourth quarter of 2021.
This liability was settled during 2022.
Bioasis Loans
On 19 December 2022 the Company entered into a
Promissory Note and Security Agreement with Bioasis to assist in
the short term with Bioasis’ working capital requirements. Under
the agreement the Company agreed to advance Bioasis up to
US$750,000 in 3 tranches payable on 19 December 2022, 3 January
2023 and 6 February 2023.
The Company advanced US$250,000 to Bioasis in
the year to 31 December 2022. A further advance of US$250,000 was
made to Bioasis on 3 January 2023.
Management considered recovery of the debt to be
uncertain and in 2022 recognised an impairment provision of
£207,000 against the advance made in December 2022, and a provision
of £207,000 against future credit losses resulting from the
Promissory Note.
On 3 February 2023 Bioasis announced they were
‘urgently exploring and evaluating all financing and strategic
alternatives that may be available to address its liquidity
requirements’ which triggered an event of default. As a result of
this the 3rd payment under the agreement was not made in the post
year end period. On 5 March 2023 Bioasis were served with a notice
of an event of default. On 20 June 2023 Bioasis announced the
suspension of operations.
In 2023 the provision was utilised against the
advance made to Bioasis in January 2023.
8 Derivative
financial liability – current
|
2023£’000 |
2022£’000 |
2021£’000 |
Equity settled derivative financial liability |
|
|
|
At 1 January |
85 |
553 |
1,559 |
Warrants issued |
4,562 |
– |
– |
Transfer to share premium on exercise of warrants |
– |
– |
(70) |
Gain recognised in finance (income)/expense within the consolidated
statement of comprehensive income |
(487) |
(468) |
(936) |
At 31 December |
4,160 |
85 |
553 |
Equity settled derivative financial liability is
a liability that is not to be settled for cash.
No warrants recognised as equity settled
derivatives were exercised in 2023, 2022 or 2021.
The Company issues warrants in the ADSs of the
Company as part of registered direct offerings and private
placements in the US. The number of ADSs to be issued when
exercised is fixed, however the exercise price is denominated in US
Dollars being different to the functional currency of the Company.
Therefore, the warrants are classified as equity settled derivative
financial liabilities recognised at fair value through the profit
and loss account (‘FVTPL’). The financial liability is valued using
the Black-Scholes model in 2023, in previous periods the Monte
Carlo model was used. The change in methodology is as result of the
Company de-listing from AIM in 2023 and no longer needing to
consider foreign exchange movements in fair value calculation.
Financial liabilities at FVTPL are stated at fair value, with any
gains or losses arising on re-measurement recognised in profit or
loss. The net gain or loss recognised in profit or loss
incorporates any interest paid on the financial liability and is
included in the ‘finance income’ or ‘finance expense’ lines item in
the income statement. A key input in the valuation of the
instrument is the Company share price.
Details of the warrants are as follows:
December 2023 warrants
In December 2023 the Company issued 3,000,063
Series E ADS Warrants and 3,000,063 Series F ADS Warrants as part
of the Registered Offering in the US. The exercise price per ADS is
$2.20.
May 2023 warrants
In June 2023 the Company issued 276,689 Series D
ADS Warrants as part of a registered direct offering and private
placement in the US after securing shareholder approval. The
exercise price per ADS was $16.00.
May 2020 warrants
In May 2020 the Company issued 838 ADS warrants
as part of a registered direct offering in the US.
October 2019 warrants
In October 2019 the Company issued 392 ADS
warrants as part of a registered direct offering in the US.
May 2020 and October 2019 warrant
re-price
On 13 December 2022 the Company entered into a
Securities Purchase Agreement with Armistice Capital Master Fund
Ltd (‘Armistice’) to re-price previously issued ADS warrants issued
to Armistice to $320 per ADS. The impact of the re-pricing is shown
in the table below: The warrant exercise price per ADS for the
remaining warrants remains unchanged as follows: October 2019
warrants at $10,000 per ADS; May 2020 warrants at $3,280 and $3,300
per ADS.
|
ADS Warrants Number* |
Original price per ADS* |
New price per ADS |
Equivalent Ordinary Shares (400 ordinary shares per
ADS)Number |
October 2019 warrants |
375 |
$10,000 |
$320 |
150,000 |
May 2020 warrants |
406 |
$3,280 |
$320 |
162,400 |
*Number and original price of warrants have been
adjusted to reflect the share consolidation and ratio change of
ADS’s to ordinary shares that occurred on 2 March 2020 and 24 March
2023 and the ratio change of ADS’s to ordinary shares on 26
September 2022 and 5 July 2023.
DARA warrants and share
options
The Group also assumed fully vested warrants and
share options on the acquisition of DARA Biosciences, Inc. (which
took place in 2015). The number of ordinary shares to be issued
when exercised is fixed, however the exercise prices are
denominated in US Dollars. The warrants are classified equity
settled derivative financial liabilities and accounted for in the
same way as those detailed above. The financial liability is valued
using the Black-Scholes option pricing model. The exercise price of
the outstanding options is $1,903.40.
The following table details the outstanding
warrants over ADSs and ordinary shares as at 31 December and also
the movement in the year:
|
At 1 January 2021 |
Lapsed |
Exercised |
At 31 December 2021 |
Lapsed |
At 31 December 2022 |
Lapsed |
Granted |
At 31 December 2023 |
ADSs |
|
|
|
|
|
|
|
|
|
December 2023 grant |
– |
– |
– |
– |
– |
– |
|
6,000,126 |
6,000,126 |
May 2023 grant |
– |
– |
– |
– |
– |
– |
|
276,689 |
276,689 |
May 2020 grant |
876 |
– |
(38) |
838 |
– |
838 |
– |
– |
838 |
October 19 grant |
392 |
– |
– |
392 |
– |
392 |
– |
– |
392 |
Ordinary Shares |
|
|
|
|
|
|
|
|
|
DARA Warrants |
231 |
(27) |
– |
204 |
(204) |
– |
– |
– |
– |
DARA Options |
138 |
– |
– |
138 |
|
138 |
(10) |
– |
128 |
*Number and original price of warrants have been
adjusted to reflect the share consolidation and ratio change of
ADS’s to ordinary shares that occurred on 2 March 2020 and 24 March
2023 and the ratio change of ADS’s to ordinary shares on 26
September 2022 and 5 July 2023.
9 Share
capital
Authorised, allotted and fully paid –
classified as equity |
2023Number |
2023£ |
2022Number |
2022£ |
2021Number |
2021£ |
At 31 December |
|
|
|
|
|
|
Ordinary shares of £0.001 each |
1,189,577,722 |
1,189,578 |
5,417,137 |
108,343 |
4,923,420 |
98,468 |
‘A’ Deferred shares of £1 each |
1,000,001 |
1,000,001 |
1,000,001 |
1,000,001 |
1,000,001 |
1,000,001 |
‘B’ Deferred shares of £0.001 each |
4,063,321,418 |
4,063,321 |
– |
– |
– |
– |
Total |
|
6,252,900 |
|
1,108,344 |
|
1,098,469 |
At a General Meeting on 24 March 2023,
shareholders approved a consolidation of the Company’s Ordinary
Shares on a one for 20 basis. As a result, the par value of the
Ordinary Shares was changed from £0.001 per share to £0.02 per
share. At the same time, the ratio of the Company’s Ordinary Shares
to ADSs was changed from each ADS representing 25 Ordinary Shares
to each ADS representing five Ordinary Shares.
At a General Meeting on 14 June 2023,
shareholders approved the subdivision and redesignation of the
Company’s Issued Ordinary Shares of £0.02 each into to one Ordinary
Share of £0.001 each and 19 ‘B’ Deferred Shares of £0.001 each. The
‘B’ Deferred Shares have limited rights and are effectively
valueless. The previously issued Deferred Shares were redesignated
‘A’ Deferred Shares.
On 5 July 2023 the Company effected a ratio
change in the number of Ordinary Shares represented by ADSs from
five Ordinary Shares per ADS to 400 Ordinary Shares per ADS.
On 26 May 2023 the Company entered into Private
Placement and on 21 December 2023 the Company entered into a
Registered Offering. As no share premium was recognised in relation
to these transactions the transaction costs have been charged to
retained earnings.
During the year the Company issued the following
warrants over ADSs, and these were recognised in the warrant
reserve until exercise:
|
Pre-Funded Warrants |
Series A Warrants |
Series B Warrants |
Series C Warrants |
Exercise price |
£0.0001 |
$214.40 |
$214.40 |
$16.00 |
As at 1 January 2023 |
– |
– |
– |
– |
Issued: |
|
|
|
|
Private Placement February 2023 |
155,461 |
32,327 |
48,491 |
– |
Registered Direct Offering May 2023 |
– |
– |
– |
415,043 |
Registered Offering December 2023 |
1,911,176 |
– |
– |
– |
Adhera Assignment and Exchange Agreement |
899,642 |
– |
– |
– |
Exercised |
(155,461) |
(32,327) |
(48,491) |
(415,043) |
As at 31 December 2023 |
2,810,818 |
– |
– |
– |
The Series A, Series B and Series C warrants are
exercisable on an ‘alternative cashless basis’ effectively allowing
the holders to exercise for nil consideration.
Numbers of shares and share options/ warrants
and related exercise/issue prices are after the impact of the 24
March 2023 share consolidation, ADS ratio changes on 24 March 2023
and 5 July 2023.
In accordance with the Articles of Association
for the Company adopted on 14 June 2023, the share capital of the
Company consists of an unlimited number of ordinary shares of
nominal value £0.001 each. Ordinary and deferred shares were
recorded as equity.
Rights attaching to the shares following
the incorporation of Biodexa Pharmaceuticals plc
Shares classified as equity
The holders of ordinary shares in the capital of
the Company have the following rights:
(a) to receive notice of, to attend and to vote
at all general meetings of the Company, in which case shareholders
shall have one vote for each share of which he is the holder;
and,
(b) to receive such dividend as is declared by
the Board on each share held.
The holders of both classes of deferred shares
in the capital of the Company:
(a) shall not be entitled to receive notice of
or to attend or speak at any general meeting of the Company or to
vote on any resolution to be proposed at any general meeting of the
Company; and
(b) shall not be entitled to receive any
dividend or other distribution of out of the profits of the
Company.
In the event of a distribution of assets, the
deferred shareholders shall receive the nominal amount paid up on
such share after the holder of each ordinary share shall have
received (in cash or specie) the amount paid up or credited as paid
up on such ordinary share together with an additional payment of
£100 per share. The Company has the authority to purchase the
deferred shares and may require the holder of the deferred shares
to sell them for a price not exceeding 1p for all the deferred
shares.
|
|
Ordinary SharesNumber |
‘A’ Deferred SharesNumber |
‘B’ Deferred SharesNumber |
Share
Price£ |
Total consideration£’000 |
At 1 January 2021 |
3,153,694 |
1,000,001 |
|
|
|
19 February 2021 |
Exercise of warrants |
15,340 |
|
|
5.960 |
91 |
6 July 2021 |
Placing |
1,754,386 |
|
|
5.700 |
10,000 |
At 31 December 2021 |
4,923,420 |
1,000,001 |
|
|
|
22 March 2022 |
Exercise of Warrants |
1 |
|
|
200.000 |
- |
3 May 2022 |
Share issue to SIPP trustee |
1,250 |
|
|
0.001 |
- |
19 December 2022 |
Registered District Offering |
492,466 |
|
|
0.666 |
321 |
At 31 December 2022 |
5,417,137 |
1,000,001 |
|
|
|
15 February 2023 |
Private Placements* |
98,387,275 |
|
|
0.0505 |
4,967 |
26 May 2023 |
Registered Direct Offering* |
276,697,310 |
|
|
0.0097 |
2,690 |
14 June 2023 |
Share sub-division and re-designation |
|
|
4,063,321,418 |
n/a |
n/a |
21 December 2023 |
Shares issued to purchaseIntangible asset (see note 5) |
323,684,800 |
|
|
0.0040 |
1,279 |
21 December 2023 |
Registered Offering |
485,391,200 |
|
|
0.0040 |
1,918 |
At 31 December 2023 |
1,189,577,722 |
1,000,001 |
4,063,321,418 |
|
|
*Number of shares issued includes exercise of
pre-funded warrants and Series A, Series B and Series C warrants
that were exercisable on an ‘alternative cashless basis’.
10 Contingent liabilities
The Company entered into an Arrangement
Agreement with Bioasis on 13 December 2022 as amended on 18
December 2022. Under the agreement the Company agreed to acquire
the entire issued share capital of Bioasis for consideration of, in
aggregate, approximately C$7.4 million (c£4.4 million). The
agreement was subject to shareholder approval. On 23 January 2023
at the General Meeting to approve the Arrangement Agreement none of
the special resolutions were passed and, accordingly, the
acquisition of Bioasis did not proceed. Under the agreement the
Company agreed to reimburse Bioasis US$225,000 expenses relating to
the transaction should the Company’s shareholders not approve the
transaction. On 3 March 2023 the Company advised Bioasis that it
would offset this liability against the sums it advanced as
disclosed in note 13.
As at 31 December 2023 and 31 December 2022 the
Company had a contingent liability of $225,000 in relation to this
potential liability.
11 Post Balance Sheet Events
On 22 January 2024 membership of the Board
Committees were changed to the following:
|
Audit Committee |
Remuneration Committee |
Nominations Committee |
Stephen Parker |
X |
|
X* |
Sijmen de Vries |
|
X* |
X |
Ann Merchant |
X |
X |
|
Simon Turton |
X* |
X |
X |
*Chair of Committee |
|
|
|
Biodexa Pharmaceuticals (NASDAQ:BDRX)
Historical Stock Chart
From Apr 2024 to May 2024
Biodexa Pharmaceuticals (NASDAQ:BDRX)
Historical Stock Chart
From May 2023 to May 2024