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BE IN THE PUBLIC DOMAIN.
BIVICTRIX THERAPEUTICS
PLC
("BiVictriX" or "the Company" or "the
Group")
Final results for the year
ended 31 December 2023
· Significant scientific and corporate
progress towards first clinical study for BVX001 in Acute Myeloid
Leukaemia ("AML")
·
Expansion of
the Bi-Cygni® discovery across ten solid and haematological tumour
types and strengthening of our IP portfolio
· BVX001 - Positive INTERACT
meeting with the FDA with strong regulatory alignment of our
ongoing IND-enabling plans; US Orphan Drug Designation granted by
the FDA for BVX001, post period end
·
Targeting two
ready-for-clinic Bi-Cygni® antibody drug conjugates ("ADCs") in
2026
Alderley Park, 31 May 2024
- BiVictriX Therapeutics
plc (AIM: BVX), a drug discovery and development company applying
an innovative, proprietary approach to develop a new class of
highly selective, next generation cancer therapeutics, bispecific
antibody drug conjugates (Bi-Cygni® ADCs),
which exhibit superior potency, whilst eliminating
treatment-related toxicities, today announces its audited results
for the twelve months ended 31 December 2023. The
Annual Report and Accounts for the year ended 31 December 2023,
will be posted to shareholders in due course together with the
notice of the 2024 Annual General Meeting.
Corporate Highlights including post
period end events
·
Compelling data generated to demonstrate the potential
and differentiation of the drug in the treatment of AML, including
improved characterisation of BVX001's target patient population,
clinical position and commercial opportunity
·
Interim data from an established preclinical
model delivered promising safety data for BVX001, highlighting our
potential starting dose selection for first-in-human studies and
the product's wide therapeutic window
·
Successful fund raise of £2.1 million gross proceeds with
support from existing and new investors, completed on 8th August
2023 at a subscription price of 13p/share
·
Selection of a preclinical lead for BVX002, our
lead solid tumour targeting product with a lead target indication
of ovarian cancer identified based on strong data
·
Strengthening of our external scientific and
clinical advisory network to include Dr Eric Rowinsky and Dr Tami
Rashal, experts in the solid tumour and haematological fields,
respectively
·
Two leadership appointments including Dr Michael Kauffman as
Non-Executive Chairman and Dr Adrian Howd as Chief Financial
Officer (CFO) and Chief Business Officer (CBO)
Financial highlights
·
Investment in R&D of £2.0 million (2022: £2.1
million)
·
Loss after tax of £2.5 million (2022: £2.5
million)
·
Cash and cash equivalents of £3.3 million at 31
December 2023 (2022: £3.3 million)
Tiffany
Thorn, Chief Executive Officer of BiVictriX,
commented: "2023 has been a remarkable year for
BiVictriX. We have made considerable progress with BVX001, the
Company's lead bispecific ADC, towards getting this asset ready for
the clinic, identifying our route to market and attracting the
support of globally recognised KOLs in the AML space. Post period
end, we have continued to make significant progress across our
wider portfolio, and we are on track to nominate a clinical
candidate for our solid tumour programme, BVX002, and further
expand our IP portfolio, increasing the value proposition for our
shareholders. I would like to thank our dedicated scientific team
and our valued shareholders for their continued support as we look
to forward to realising the value across our next-generation
therapeutic programmes."
For more information, please
contact:
BiVictriX
Therapeutics plc
|
|
Tiffany Thorn, Chief Executive
Officer
|
Email:
info@bivictrix.com
|
|
|
SP Angel
Corporate Finance LLP (NOMAD and Broker)
|
Tel: +44 (0) 20 3470 0470
|
|
David Hignell, Caroline Rowe, Kasia Brzozowska
(Corporate Finance)
Vadim Alexandre, Rob Rees (Sales and
Broking)
|
|
|
Panmure Gordon (UK) Limited (Joint Broker)
|
Tel: +44 (0) 20 7886 2500
|
|
Rupert Dearden/Freddy
Crossley/Emma Earl
ICR
Consilium
|
|
Mary-Jane Elliott, Namrata Taak,
Max Bennett, Emmalee Hoppe, Dylan
Wilks
|
Tel: +44 (0) 20 3709 5700
Email:
Bivictrix@consilium-comms.com
|
|
|
|
|
About BiVictriX
Therapeutics plc
BiVictriX is a UK-based drug
discovery and development company which is focused on leveraging
clinical experience to develop a new class of highly selective,
next generation cancer therapeutics which exhibit superior potency,
whilst significantly reducing treatment-related
toxicities.
The Company utilises a
first-in-class approach to generate a proprietary pipeline of
Bi-Cygni® Antibody Drug Conjugate therapeutics which are designed
to selectively target cancer-specific antigen pairs, or "Bi-Cygni®
fingerprints", on tumour cells, which are largely absent from
healthy cells.
BiVictriX has established a
growing proprietary library of cancer-specific Bi-Cygni®
fingerprints, which enable the Company to target a diverse array of
different cancer types. The Company utilises these novel Bi-Cygni®
fingerprints, together with the Company's novel Antibody Drug
Conjugate therapeutic design, to develop more effective and safer
therapeutics to target cancers that are expected to constitute
orphan indications and areas of high unmet medical need.
Find out more about BiVictriX
online at www.bivictrix.com
Chairman's
Statement
For the year
ended 31 December 2023
It is a pleasure to report on the Company's
developments and progress in 2023, which was my first year as the
Company's Chairman. Our science continues to deliver differentiated
data and I look forward to meeting our objectives of becoming a
clinical ADC company.
My first year as Chairman of BiVictriX has
seen considerable progress on multiple fronts and I have enjoyed
working with our CEO, Tiffany Thorn, the Senior Management Team and
the Board to ensure we are well placed to make the best of what we
have and achieve our goal of developing novel, differentiated
bispecific ADCs.
During 2023, we generated promising
preclinical safety and efficacy data for our lead product, BVX001.
The data supports our view of a differentiated clinical profile
which may offer distinct advantages for the treatment of AML, a
disease with significant unmet medical need.
I have been working closely with the team to
sharpen our clinical trial plan for BVX001, complete a robust
preclinical data package and ensure we maximise our first-in-human
study and position the product accordingly.
To that end, we were delighted to be granted
an INTERACT meeting with the FDA after period end, and our initial
regulatory interactions have been highly constructive and aligned
with our strategic thinking.
In December 2023 we held an inaugural key
opinion leader meeting with a number of world-renowned AML experts
to appraise BVX001, which I chaired. We gained positive endorsement
for our approach and data from which we will leverage, particularly
as we move to the next phase of clinical trial planning and
principal investigator contact.
Our technology platform continues to offer
significant opportunities in the larger solid tumour space, and we
accelerated our efforts in relation to BVX002 during 2023, with an
initial therapeutic focus in the ovarian cancer setting. New target
pairs are rapidly emerging from our R&D activities, and we look
to broaden the applicability of our technology and further
developing our pipeline of novel therapies during 2024.
We have achieved a lot whilst prudently
managing our cost base in 2023, and I have worked with the team to
ensure we focus on the generation of the optimal data sets to
properly evaluate our assets and their path to the
clinic.
The opportunity from our science is
significant, and I am proud of the differentiation and progress we
have made in 2023 and the trajectory of our business in this highly
valuable therapeutic segment.
I would like to take this opportunity to thank
my fellow Directors for their strategic input, governance and
oversight during the year. The whole team at Alderley Park led by
our CEO, Tiffany Thorn, have made much progress through their hard
work and I thank them all.
Lastly, I wish to thank all of our
shareholders for their loyal support of our vision and for enabling
us to continue striving to develop new, game changing cancer
therapeutics.
Michael
Kauffman, M.D., Ph.D.
Non-Executive
Chairman of BiVictriX Therapeutics PLC
31 May
2024
Chief Executive
Officer's Review
For the year ended 31 December 2023
It is my privilege to present the
Company's third Annual Report as CEO of BiVictriX Therapeutics plc.
I am delighted to report the achievements we have made to advance
our novel approach to develop more effective and safer anti-cancer
therapeutics - targeting the cancer, not the patient. This would
not be possible without the valued support of our talented staff
and our shareholders, to whom I am thankful for their confidence
and trust in BiVictriX.
The business
BiVictriX is a UK-based drug
discovery and development company which is focused on leveraging
clinical experience to develop a new class of highly selective,
next generation cancer therapeutics which exhibit superior potency,
whilst significantly reducing treatment-related
toxicities.
The Company utilises a
first-in-class approach to generate a proprietary pipeline of
Bi-Cygni® Antibody Drug Conjugate ("ADC") therapeutics which are
designed to selectively target cancer-specific antigen pairs, or
"Bi-Cygni® fingerprints", on tumour cells, which are largely absent
from healthy cells. BiVictriX operates in the ADC space, which
showed a very significant year of corporate activity in 2023, and I
am pleased to report the Company has continued to make strong
progress in line with our strategy.
There are over 180 ADCs in
clinical development, but only 3 of these are bispecific ADCs that
target twin antigens in a similar manner to BiVictriX. Global
revenues of the 16 approved ADC therapies reached $9.7
billion[1] in 2023
and are forecasted to grow to $19.8bn by 20281. BiVictriX has established a
growing proprietary library of cancer-specific Bi-Cygni®
fingerprints, enabling the Company to target a diverse array of
different cancer types.
Our lead programme, BVX001, is
focused on Acute Myeloid Leukaemia ("AML"), one of the most
aggressive forms of blood cancer with one of the poorest overall
survival rates across all cancers. All currently approved AML
therapies are associated with severely toxic side effects,
including potentially fatal infections and sepsis, limiting their
use to younger, fitter patients.
Bi-Cygni®: A first-in-class approach to treat
cancer
Bi-Cygni® is a unique, proprietary
platform which combines the discovery of novel, cancer-selective
twin-antigen pairs or "fingerprints" (typically two different
proteins), with bispecific antibody engineering insights; to create
a new class of highly selective, next-generation anti-cancer
therapeutics. Together with our proprietary library of these novel
cancer-specific fingerprints, which are found to be aberrantly
present on tumour cells, but largely absent from normal, healthy
cells; we develop first-in-class bispecific therapeutics (Bi-Cygni®
therapeutics) that are highly cancer-selective.
As our Bi-Cygni® therapeutics have
high selectivity for cancer cells with reduced toxicity on normal
cells, we have the potential to generate a pipeline of anti-cancer
drugs across both solid and haematologic cancers with very wide
therapeutic windows. Consequently, these drugs have the potential
to reduce the development of treatment-limiting (and sometimes
life-threatening) toxicities and enable clinicians to give patients
higher, more effective doses of therapy over prolonged periods, to
improve both depth and duration of anti-tumour responses with
reduced likelihood of causing harm.
The Company has maintained its
vision to combine innovation in therapeutic design with
established, clinically validated, therapeutic modes of action.
Applying advances in our understanding of precision targeting
through the Bi-Cygni® platform to the established, highly potent
ADC concept enables us to generate a broad pipeline of next
generation ADC therapeutics which could deliver increased tumour
cell kill while reducing effects on normal cells.
Thus, my fellow Directors and I
believe that in the clinic, these therapeutics will have the
potential to deliver very high response rates and longer-term
tolerability over and above the standard ADC design, while
effectively reducing early developmental risk and time-to-market.
This will enable, for the first time, the broader utilisation of
this therapeutic class across a wider range of difficult-to-treat
solid tumour and haematologic cancers.
Key achievements in 2023
Having continued to prioritise
R&D progress, particularly BVX001 and successfully completed a
£2.1 million (gross) fundraise in August 2023, we have made good
progress in the period, which additionally included:
·
Strengthened the BVX001 preclinical data package
for AML with positive data from a toxicity evaluation study and
from two in vivo efficacy
studies in murine models
·
Patents granted in the United States and Japan
providing very broad protection for BVX001 with patent protection
being prosecuted in a further six jurisdictions
·
Two leadership appointments including Dr Michael
Kauffman as Non-Executive Chairman and Dr Adrian Howd as Chief
Financial Officer (CFO) and Chief Business Officer (CBO)
·
Hosted inaugural roundtable discussion with
globally renowned clinical experts in the ADC space to assist in
shaping a route for BVX001 to patients
A more detailed description of our
progress and key drivers follows below.
Board and Leadership Team
On 6 January 2023, we announced
that Dr Michael Kauffman, M.D., Ph.D. was appointed as
Non-Executive Chairman of BiVictriX. Dr Kauffman took over the role
from Iain Ross, who continued as a Non-Executive Director at
BiVictriX until 5 December 2023.
Dr Kauffman has taken over as
Non-Executive Chairman at a crucial time for the Company, as we
progress BVX001 towards first in human studies. Since his
appointment to the Board of Directors in January 2022, Dr Kauffman
has seen us rapidly progress BVX001 from an early-stage asset
towards a clinical candidate.
Having been instrumental in the
approval of several oncology therapeutics, including XPOVIO®,
Kyprolis® and Velcade®, and bringing over twenty-five years of
working across preclinical research, clinical development,
regulatory strategy and commercialisation, Dr Kauffman is very well
placed to draw from his experience as a seasoned cancer drug
developer to support the business at this juncture.
I would like to personally thank
Iain Ross for his commitment and support of the business. His
mentorship, and his valued guidance were instrumental to taking the
Company from a private entity to a publicly listed business and
beyond, and I would like to wish him all the very best for the
future.
On 3 October 2023, we appointed
Adrian Howd as CFO and CBO. Adrian joined
BiVictriX with over 20 years of strategic, financial and commercial
experience in the biopharmaceutical industry, having held various
financial roles, private and public executive management positions
and board roles across the sector, including Chief Investment
Officer and Chief Executive Officer at investment firm, Malin
plc.
During his career, he has led
multiple asset and corporate business development transactions, as
well as numerous equity capital market fundraises totalling over
€430 million in the UK and overseas, gained during his previous
senior roles at Malin, Berenberg, ABN Amro, and
Nomura.
Notably, Adrian led early
investments in, and served on the Boards of Immunocore (a UK based
company with an FDA approved bispecific cancer therapy, KIMMTRAK)
and Kymab, two highly successful UK platform-based therapeutic
companies, which both achieved multi $bn exits on NASDAQ and
through M&A respectively.
These additions strengthen the
BiVictriX team for the next phase of growth.
Internal R&D capabilities
In 2023, we dedicated significant
operational and financial resources to R&D, having invested
£2.0 million. This investment has enabled us to advance our lead
asset BVX001 to IND-enabling studies and accelerate solid tumour
focus with BVX002, advancing the Group's lead and pipeline
programmes. Ultimately, this will reduce the time-to-market and
increase patent life for each asset, as well as drive further value
in the platform offering of the business.
Scientific progress
Over the last year, we have
continued to execute our development plan for our lead asset,
BVX001, marked by the achievement of several key preclinical
milestones essential for progressing this molecule towards the
clinic.
Following the identification of a
development lead for BVX001 in December 2022, the Company announced
in January 2023 additional data to strengthen the preclinical data
package for this asset in AML. This included positive in vivo results from a toxicity
evaluation study for BVX001, conducted head-to-head with the
approved clinical comparator gemtuzumab ozogamicin
("GO").
GO, marketed as Mylotarg™, is
currently the only approved ADC for the treatment of AML. These
data showed a highly favourable safety profile and reduced
off-target effects across two doses of BVX001 versus the reported
maximum tolerated dose of Mylotarg™ in a well validated toxicity
model.
These results were bolstered by
two further in vivo
efficacy studies in murine models of AML. In June 2023, we
announced the nomination of a clinical candidate for our lead
BVX001 programme following results of a four-week study. In this
study, the nominated clinical candidate demonstrated highly
statistically significant tumour regressions of up to 93% at day 28
(p-value <0.001) when compared to the untreated negative control
group, with seven of the nine animals treated reported as either
completely tumour free or with non-measurable tumours, at the end
of dosing. Importantly, no adverse effects, including weight loss,
were reported with BVX001 in these studies even, at the higher
doses tested.
Following the 28-day dosing period
and efficacy assessment, the duration of survival post treatment
was determined. In October 2023, we announced that BVX001 increased
survival rates in this difficult-to-treat pre-clinical model of AML
by 126% when compared to untreated control. The data here
demonstrating that BVX001 provides clear survival benefits, even in
this challenging AML setting.
This strong data was supported by
a second study, in which the AML tumours were established at a much
larger size relative to the first study (~650mm3 vs ~200mm3), prior
to the initiation of BVX001 dosing. Of note, many anti-cancer
agents perform less favourably in larger tumours due to reduced
drug penetration, making any anti-tumour response more significant.
In July 2023, we announced full results indicating that BVX001
retains its potent anti-tumour activity even in this more difficult
setting, demonstrating highly statistically significant tumour
regressions of 97% at day 28 (p-value <0.001), with five of the
six animals treated reported as either completely tumour free or
with non-measurable tumours at the end of dosing; all placebo
treated animals had growing tumours. Again, there were no
observed adverse effects with BVX001. Further preclinical studies
will be progressed to support regulatory approvals to initiate
human trials.
Together, these studies offer a
strong preclinical data package, demonstrating the significant
potential of BVX001 as an effective treatment for AML offering a
much wider therapeutic window, supporting our plans to progress
BVX001 into the clinic. Further, it provides validation of our
wider Bi-Cygni® platform to improve cancer-specific targeting,
reducing potentially harmful or fatal side effects across a broad
range of cancer indications.
We have continued to broaden our
patent portfolio with the addition of new filings to provide
further robust protection for BVX001 and the wider platform,
including BVX002 and our proprietary bispecific antibody format. We
also received notice that our patent from the initial broad patent
family, which provides wide protection for BVX001 at the antigen
fingerprint level, has been granted in the United States and
Japan.
The claims granted provide broad
protection to prevent any third party from developing an
antibody-based therapeutic which is linked to a cytotoxic payload
and requires binding to CD33 and CD7, for use across any CD7+CD33+
haematological cancer type. Along these lines, in addition to
AML, both CD33 and CD7 are expressed in a subset of patients with
Myelodysplastic Syndromes and T-Cell Acute Lymphoblastic Leukaemia,
as well as patients with other cancer types.
In addition to the aforementioned,
the Company is pursuing prosecution for this patent family in a
further six global jurisdictions. This will ultimately provide
worldwide protection for the therapeutic asset, at the broadest
level, across all relevant markets, with further patent grants
anticipated within the coming months.
Good progress has also been made
across our two discovery-stage, solid tumour programmes, BVX002 and
BVX003. The Company is on track to nominate a clinical candidate
for BVX002, the Company's second proprietary programme targeting
high unmet in Ovarian Cancer, in the second half of this year,
following the successful identification of a development lead
earlier in the year. Mounting early-stage third-party interest in
this asset is currently being explored by the Company.
Further to this, we have
successfully taken our third programme, BVX003, which can target a
range of solid tumour types, from initial pipeline discovery
through to the identification of a therapeutic development lead.
This programme is now available for partnership; enabling the core
R&D team at BiVictriX to focus internally on progressing BVX001
and BVX002 towards the clinic.
Commercial strategy
The Board and our team believe the
Bi-Cygni® platform can create a portfolio of first-in-class
therapeutics for various solid and blood cancer types, providing a
competitive edge over the current drugs under development and
meeting critical market needs.
BiVictriX's goal is to prove the
Bi-Cygni® method in a range of hard-to-treat cancer types, starting
with BVX001 in AML, to show the broad potential of the concept,
driving the Group as a world leader in the field.
We are dedicated to achieving
maximum value by developing our therapeutic pipeline in a focused
and effective manner, reaching key milestones that validate the
wide applicability of our exclusive Bi-Cygni® method for treating
various cancer types. We aim to do this while also ensuring we
utilise our capital in the most efficient manner to reach the
value-enhancing milestones that matter to our shareholders. For
this reason, we have decided to dedicate our internal R&D focus
on our two leading assets, BVX001 and BVX002, which together
showcase the Company's technology platform across both solid and
liquid tumour types, and which are already gaining traction with
potential partners. The Company is looking to explore all options
regarding early-stage collaborations which may support the
progression of the pipeline towards key value-inflection
points.
We believe that BVX001, as our
most advanced asset, is critical in providing validation to the
market for the wider Bi-Cygni® platform as a disruptive new
approach in the oncology therapeutic sector. Based upon the
promising data generated to date, our aim is to progress this asset
to achieve full IND approval and establish early clinical proof of
concept through an initial Phase I/II clinical trial, with the
focus on attracting third party interest at key junctures within
this development pathway, who may be interested in partnerships
and/or licensing opportunities, providing long-term revenue streams
to BiVictriX. To support this, our next immediate goal is to
finalise our initial preclinical data package with a key readout on
the safety of the therapeutic in a well-established model of
toxicity, with final data expected by end H1 2024.
As we near completion of this
major corporate milestone, we will continue to drive interest in
the Company at relevant sector conferences, building upon our
well-received presentations and active involvement at the
Immuno-Oncology Summit Europe and PEGS Europe during the
period.
I was also delighted by BiVictriX
being included in the 2023 roundup of
BusinessCloud's MedTech 50, an
annual ranking of the most innovative medical technology creators
in the UK. We have also increased our engagement with key
consultants in the field to support our business development focus
and to optimise our potential opportunities.
We have received interest in our
platform, and our goal is to balance the commercial value of both
our platform and our specific programmes, with suitable deal
structures for the Company and our stakeholders.
Immediate goals
Through our expanding pipeline,
broad patent portfolio and internal know-how, the Company is well
positioned to progress our pipeline and build collaborative
alliances.
To succeed at achieving these
goals we are focused on delivering upon the following key
milestones:
·
Generation of further preclinical data for BVX001
to complete the safety and efficacy data package
·
Further engagement with the FDA and MHRA to
finalise the regulatory pathway to the clinic
·
Finalise the manufacturing strategy for
BVX001
·
Nomination of a clinical candidate for the BVX002
programme, targeting ovarian cancer, our first solid tumour
programme
·
Securing discovery and clinical development stage
collaborations with industry partners to support and accelerate the
progression of our lead assets to clinical proof of concept,
regulatory approvals and commercialisation
Financials
Management controls operate across
the business to ensure that our financial resources are prioritised
towards further development of the Company's therapeutic programmes
and platform to reach the key value points.
This focus was reflected in the
R&D expenditure for the year of £2.0 million, broadly
consistent with that reported in the prior year (2022: £2.1
million); together with a loss after tax of £2.5 million (2022:
£2.5 million).
The Group ended the year with a
cash balance of £3.3 million (2022: £3.3 million) following the
successful fundraising in August 2023, raising £2.1 million
(gross).
Summary and outlook
I am extremely encouraged by the
progress we have made during and after the period, including the
striking progression of our lead therapeutic programme towards the
clinic, together with the development of our solid tumour assets
and further strengthening of our broad IP portfolio.
As we draw closer to reaching key
inflection points during 2024, our focus will be on increasing the
visibility of the Company and demonstrating the clear value
proposition to third parties.
I remain fully committed to our
business goals, our continued delivery against objectives and to
prioritising our capital allocation to create further significant
value and multiple potential opportunities for financial return to
our valued shareholders.
Finally, and on a personal note, I
would like to thank our exceptional scientific and corporate team
for their enthusiasm, commitment, and hard work over the past
twelve months, without which our progress to date would not have
been possible, the Board for their guidance throughout the period
and of course, our shareholders for their continued support and
investment in our business.
Tiffany
Thorn
Chief
Executive Officer
31 May 2024
Consolidated Statement of Comprehensive
Income
For
the year ended 31 December 2023
|
Notes
|
Year Ended
31 December
2023
|
Year
Ended
31
December 2022
|
£'000
|
£'000
|
Operating expenses
|
|
|
|
Research and
Development
|
3
|
(2,047)
|
(2,110)
|
General and
Administration
|
3
|
(904)
|
(738)
|
Share based
compensation
|
14
|
(74)
|
(127)
|
Total operating expenses before non-recurring
costs
|
|
(3,025)
|
(2,975)
|
Operating loss
|
|
(3,025)
|
(2,975)
|
Finance income/(cost)
|
|
22
|
4
|
Loss on ordinary activities before taxation
|
|
(3,003)
|
(2,971)
|
Taxation
|
6
|
458
|
474
|
Loss and total comprehensive expenses attributable to equity
holders of the parent for the year
|
|
(2,545)
|
(2,497)
|
Loss per share attributable to equity holders of the parent
(pence)
|
7
|
|
|
|
|
|
|
Basic loss per share
(pence)
|
|
(3.50)
|
(3.78)
|
Diluted loss per share (pence)
|
|
(3.50)
|
(3.78)
|
|
|
|
| |
Consolidated and
Company Statements
of Financial Position
as at
31 December
2023
|
|
Group
|
Company
|
|
|
Notes
|
As at
31 December
2023
£'000
|
As
at
31
December 2022
£'000
|
As at
31 December
2023
£'000
|
As
at
31
December 2022
£'000
|
Assets
|
|
|
|
|
|
Non-current assets
|
|
|
|
|
|
Property, plant and equipment
|
8
|
476
|
571
|
-
|
-
|
Investment in subsidiary undertakings
|
9
|
-
|
-
|
7,040
|
5,387
|
Total non-current assets
|
|
476
|
571
|
7,040
|
5,387
|
Current assets
|
|
|
|
|
|
Trade and other
receivables
|
10
|
144
|
224
|
48
|
74
|
Current tax
receivable
|
|
396
|
454
|
-
|
-
|
Cash and cash
equivalents
|
11
|
3,279
|
3,287
|
3,126
|
3,002
|
Total current assets
|
|
3,819
|
3,965
|
3,174
|
3,076
|
Total assets
|
|
4,295
|
4,536
|
10,214
|
8,463
|
Liabilities and equity
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
|
Trade and other
payables
|
12
|
496
|
284
|
74
|
43
|
Lease liabilities
|
15
|
128
|
107
|
-
|
-
|
Total current liabilities
|
|
624
|
391
|
74
|
43
|
Non-current liabilities
|
|
134
|
188
|
-
|
-
|
Total liabilities
|
|
758
|
579
|
74
|
43
|
Equity
|
|
|
|
|
|
Ordinary shares
|
13
|
825
|
661
|
825
|
661
|
Share premium
|
13
|
13,939
|
12,052
|
9,889
|
8,002
|
Share based
compensation
|
13
|
425
|
351
|
425
|
351
|
Warrant reserve
|
13
|
73
|
73
|
73
|
73
|
Merger reserve
|
13
|
(2,834)
|
(2,834)
|
-
|
-
|
Retained losses
|
13
|
(8,891)
|
(6,346)
|
(1,072)
|
(667)
|
Total equity attributable to equity holders of the
parent
|
|
3,535
|
3,957
|
10,140
|
8,420
|
Total liabilities and equity
|
|
4,295
|
4,536
|
10,214
|
8,463
|
|
|
|
|
|
| |
Consolidated
Statement of Changes
in Equity
for
the year
ended
31 December
2023
|
Ordinary
shares
|
Share
Premium
|
Merger
reserve
|
Share
based compensation
|
Warrant
reserve
|
Retained
deficit
|
Total
|
|
£'000
|
£'000
|
£'000
|
£'000
|
£'000
|
£'000
|
£'000
|
Balance at 31 December 2021
|
661
|
12,052
|
(2,834)
|
224
|
73
|
(3,849)
|
6,327
|
Total comprehensive expense for the
period
|
-
|
-
|
-
|
-
|
-
|
(2,497)
|
(2,497)
|
Transactions with owners
|
|
|
|
|
|
|
|
Share based compensation - share
options
|
-
|
-
|
-
|
127
|
-
|
-
|
127
|
Total transactions with owners
|
-
|
-
|
-
|
127
|
-
|
-
|
127
|
Balance at 31 December 2022
|
661
|
12,052
|
(2,834)
|
351
|
73
|
(6,346)
|
3,957
|
Total comprehensive expense for the
period
|
-
|
-
|
-
|
-
|
-
|
(2,545)
|
(2,545)
|
Transactions with owners
|
|
|
|
|
|
|
|
Share issue - cash
|
164
|
1,969
|
-
|
-
|
-
|
-
|
2,133
|
Expense of share issue
|
-
|
(82)
|
-
|
-
|
-
|
-
|
(82)
|
Share based compensation - share
options
|
-
|
-
|
-
|
74
|
-
|
-
|
74
|
Total transactions with owners
|
164
|
1,887
|
-
|
74
|
-
|
-
|
2,125
|
Balance at 31 December 2023
|
825
|
13,939
|
(2,834)
|
425
|
73
|
(8,820)
|
3,537
|
Company Statement
of Changes
in Equity
for
the year
ended
31 December
2023
|
Ordinary shares
|
Share
premium
|
Share based compensation
|
Warrant
reserve
|
Retained deficit
|
Total
|
|
£'000
|
£'000
|
£'000
|
£'000
|
£'000
|
£'000
|
Balance
at 31 December
2021
|
661
|
8,002
|
224
|
73
|
(331)
|
8,629
|
Total comprehensive
expense for the period
|
-
|
-
|
-
|
-
|
(336)
|
(336)
|
|
|
Transactions with owners
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share
based compensation -
share
o options op options
|
-
|
-
|
127
|
-
|
-
|
127
|
|
|
|
|
|
|
|
options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total transactions with owners
|
-
|
-
|
127
|
-
|
-
|
127
|
Balance
at 31 December
2022
|
661
|
8,002
|
351
|
73
|
(667)
|
8,420
|
Total comprehensive
expense for the period
|
-
|
-
|
-
|
-
|
(405)
|
(405)
|
Transactions with owners
|
|
Transactions with owners
|
|
|
|
|
|
|
Share issue - cash
|
164
|
1,969
|
-
|
-
|
-
|
2,133
|
Expense of share issue
|
-
|
(82)
|
-
|
-
|
-
|
(82)
|
Share
based compensation -
share options
|
-
|
-
|
74
|
-
|
-
|
74
|
Total transactions with owners
|
-
|
-
|
74
|
-
|
-
|
2,125
|
Balance
at 31 December
2023
|
825
|
9,889
|
425
|
73
|
(1,072)
|
10,140
|
|
|
|
|
|
|
| |
Consolidated
and Company Statements of Cash Flows
for
the year ended 31 December 2023
|
Group
|
Company
|
Year ended 31 December 2023
£'000
|
Year ended 31 December 2022
£'000
|
Year ended 31 December 2023
£'000
|
Year ended 31 December 2022
£'000
|
Cash flows
from operating activities
|
|
|
|
|
Loss
before
taxation
|
(3,003)
|
(2,971)
|
(405)
|
(336)
|
Depreciation and amortisation
|
165
|
151
|
-
|
-
|
Share
based compensation
|
74
|
127
|
74
|
127
|
Asset write off
|
3
|
-
|
-
|
-
|
Finance costs
|
(8)
|
(4)
|
-
|
-
|
|
(2,769)
|
(2,697)
|
(331)
|
(209)
|
Changes in working capital
|
|
|
|
|
(Increase)/decrease
in trade and other receivables
|
80
|
63
|
26
|
(63)
|
Increase/(decrease)
in trade and other payables
|
213
|
25
|
31
|
41
|
Cash used in operations
|
293
|
88
|
57
|
(22)
|
Taxation received
|
516
|
212
|
-
|
-
|
Net cash used in operating activities
|
(1,960)
|
(2,397)
|
(274)
|
(231)
|
Cash flows (used in)/generated from investing
activities
|
|
|
|
|
Acquisition of tangible fixed
assets
|
(5)
|
(389)
|
-
|
-
|
Disposal of tangible fixed
assets
|
-
|
10
|
-
|
-
|
Interest received
|
22
|
-
|
-
|
-
|
Loans to subsidiary
|
-
|
-
|
(1,653)
|
(2,267)
|
Net cash (used in)/generated from investing
activities
|
17
|
(379)
|
(1,653)
|
(2,267)
|
Cash flows
from financing activities
|
|
|
|
|
Proceeds from issue of
shares
|
2,133
|
-
|
2,133
|
-
|
Issue
costs
|
(82)
|
-
|
(82)
|
-
|
Repayment of lease
liabilities
|
(116)
|
-
|
-
|
-
|
Net cash generated from financing activities
|
1,935
|
-
|
2,051
|
-
|
Movements in cash
and cash equivalents in the period
|
(8)
|
(2,776)
|
124
|
(2,498)
|
Cash
and cash equivalents
at start
of period
|
3,287
|
6,063
|
3,002
|
5,500
|
Cash and cash equivalents at end of period
|
3,279
|
3,287
|
3,126
|
3,002
|
Notes to the Financial Statements
1. General Information
BiVictriX Therapeutics plc ('the Company') is
a public limited company incorporated in England and Wales and was
admitted to trading on the AIM market of the London Stock Exchange
under the symbol "BVX" on 11 August 2021. The address of its
registered office is Mereside, Alderley Park, Alderley Edge,
Macclesfield, England, SK10 4TG and the registered company number
is 13470690. The principal activity of the Company is research and
experimental development of pharmaceutical
products.
2. Significant Accounting Policies and Basis of
Preparation
Basis of preparation
Information in this preliminary
announcement does not constitute statutory accounts of the Group
within the meaning of section 434 of the Companies Act 2006.
The annual financial information presented in this preliminary
announcement is based on, and is consistent with, the accounting
policies as disclosed in the Group's annual financial statements
for the year ended 31 December 2022 and the Group's audited
financial statements for the year ended 31 December 2023. Those
financial statements will be delivered to the Registrar of
Companies following the Company's Annual General Meeting. The
independent auditors' report on those financial statements is
unqualified and does not contain any statement under section 498
(2) or 498 (3) of the Companies Act 2006.
The consolidated financial statements have
been prepared in accordance with United Kingdom International
Financial Reporting Standards ('IFRS') as adopted by the UK, IFRIC
interpretations and the Companies Act 2006 applicable to companies
reporting under IFRS. The Company's financial statements have been
prepared in accordance with Financial Reporting Standard 102
(United Kingdom Generally Accepted Accounting
Practice).
The 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 in accordance with the policies set out
below.
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 intra-Group assets and liabilities,
equity, income, expenses and cash flows relating to transactions
between the members of the Group are eliminated on
consolidation.
Going
concern
In considering the Group's
financial commitments and forecasts, the Board have followed the
guidelines published by the Financial Reporting Council entitled
''Guidance on Risk Management and Internal Control and Related
Financial and Business Reporting''.
In the normal course of business,
the Directors regularly review rolling cash flow forecasts.
The review of financial forecasts and cash flows looking
at least 12 months from the approval of these financial statements
includes levers and controls which could be applied, if
necessary.
The Board has considered ongoing
international conflicts and the impact that they may have on
worldwide supplies; together with foreign exchange risk and the
reducing inflationary outlook. These risks are closely monitored as
part of controlled, defined expenditure to meet business
objectives.
Operational cashflows focus on
planned research and development activities to advance the Group's
lead and pipeline programmes. The timing and quantum of this
expenditure is under the control and direction of management with
oversight provided by the Board.
After considering cash flow
forecasts and associated risks, the Directors have a reasonable
expectation that the Group has adequate resources to continue in
operational existence for the foreseeable future.
Accordingly, the Company continues to adopt the going concern basis
in preparing these financial statements.
At 31 December 2023, the Group had
cash and cash equivalents of £3.3 million.
Standards, interpretations and amendments to published
standards not yet effective
The Directors have considered those standards
and interpretations, which have not been applied in these financial
statements, but which are relevant to the group's operations, that
are in issue but not yet effective and do not consider that they
will have a material effect on the future reported performance,
position or disclosure of the Group.
Currencies
Functional and presentational
currency
Foreign currency transactions are
translated into the functional currency using the exchange rates
prevailing at the dates of the transactions or at an average rate
for a period if the rates do not fluctuate significantly. Foreign
exchange gains and losses resulting from the settlement of such
transactions and from the translation at year-end exchange rates of
monetary assets and liabilities denominated in foreign currencies
are recognised in the Consolidated Statement of Comprehensive
Income. Non-monetary items that are measured in terms of historical
cost in a foreign currency are not retranslated. The presentational
currency is also the functional currency.
Property, plant and equipment
Property, plant and equipment are
stated at cost less accumulated depreciation and any impairment
losses. Cost includes the original purchase price of the asset and
the costs attributable to bringing the asset to its working
condition for its intended use.
Office equipment - 25% straight
line
Plant and equipment - 16% straight
line
Furniture, fixtures and fittings -
25% straight line
The gain or loss arising on the
disposal of an asset is determined as the difference between the
sales proceeds and the carrying amount of the asset and is
recognised in the Consolidated Statement of Comprehensive
Income.
At each reporting date, the Group
reviews the carrying amounts of its property, plant and equipment
assets to determine whether there is any indication that those
assets have suffered an impairment loss. If any such indication
exists, the recoverable amount of the asset is estimated in order
to determine the extent of the impairment loss (if
any).
Leases
The Group assesses at contract
inception whether a contract is, or contains, a lease. That is, if
the contract conveys the right to control the use of an identified
asset for a period of time in exchange for
consideration.
The Group applies a single
recognition and measurement approach for all leases, except for
short-term leases and leases of low-value assets. The Group
recognises lease liabilities, representing obligations to make
lease payments and right-of-use assets representing the right to
use the underlying assets.
Right-of-use assets
The Group recognises right-of-use
assets at the commencement date of the leases (i.e., the date the
underlying asset is available for use). Right-of-use assets are
measured at cost, less any accumulated depreciation and impairment
losses, and adjusted for any remeasurement of lease liabilities.
The cost of right-of-use assets includes the amount of lease
liabilities recognised, initial direct costs incurred, and lease
payments made at or before the commencement date less and lease
incentives received. Right-of-use assets are depreciated on a
straight-line basis over the remainder of the lease
term.
Lease liabilities
At the commencement date of the
lease, the Group recognises lease liabilities measured at the
present value of lease payments to be made over the lease term. The
lease payments include fixed payments less any lease incentives
receivable, variable lease payments that depend on an index or a
rate, and amounts expected to be paid under residual value
guarantees. The lease payments also include the exercise price of a
purchase option reasonably certain to be exercised by the Group and
payments of penalties for terminating the lease, if the lease term
reflects the Group exercising the option to terminate. The Group's
lease liabilities are included in interest-bearing loans and
borrowings.
Short-term leases and leases of low-value
assets
The Group applies the short-term
lease recognition exemption to its short-term leases of machinery
and equipment (i.e., those leases that have a lease term of 12
months or less from the commencement date and do not contain a
purchase option). It also applies the lease of low-value assets
recognition exemption to leases of office equipment that are
considered to be low value. Lease payments on short-term leases and
leases of low-value assets are recognised as an expense on a
straight-line bases over the lease term.
Extension and termination options
The Group determines the lease
term as the non-cancellable term of the lease, together with any
periods covered by an option to extend the lease if it is
reasonably certain to be exercised, or any periods covered by an
option to terminate the lease, if it is reasonably certain not to
be exercised.
The Group applies IAS 36 to
determine whether a right-of-use asset is impaired and accounts for
any identified impairment loss.
Research and development
Expenditure on pure and applied
research is charged to the profit and loss account in the year in
which it is incurred. Development costs are charged to profit and
loss account unless it can be demonstrated that the costs represent
an intangible asset which meets all of the criteria for
capitalisation set out in para 57 of
IAS38.
Income tax
The tax expense or credit
represents the sum of the tax currently payable or recoverable and
the movement in deferred tax assets and
liabilities.
(a) Current income
tax
Current tax, including R&D tax
credits which have the characteristics of income tax, is based on
taxable income for the period and any adjustment to tax from
previous periods. Taxable income differs from net income in the
Consolidated Statement of Comprehensive Income because it excludes
items of income or expense that are taxable or deductible in other
periods or that are never taxable or deductible. The calculation
uses the latest tax rates for the period that have been enacted or
substantively enacted by the dates of the Consolidated Statement of
Financial Position.
(b) Deferred tax
Deferred tax is calculated at the
latest tax rates that have been substantially enacted by the
reporting date that are expected to apply when settled. It is
charged or credited in the Consolidated Statement of Comprehensive
Income, except when it relates to items credited or charged
directly to equity, in which case it is also dealt with in
equity.
Deferred tax is the tax expected
to be payable or recoverable on differences between the carrying
amounts of assets and liabilities in the financial statements and
the corresponding tax bases used in the computation of taxable
income, and is accounted for using the liability
method.
Deferred tax liabilities are
generally recognised for all taxable temporary differences and
deferred tax assets are recognised to the extent that it is
probable that taxable income will be available against which the
asset can be utilised. Such assets are reduced to the extent that
it is no longer probable that the asset can be
utilised.
Deferred tax assets and
liabilities are offset when there is a legal right to offset
current tax assets and liabilities, and when the deferred tax
assets and liabilities relate to taxes levied by the same taxation
authority on either the same taxable entity or different taxable
entities where there is an intention to settle the balances on a
net basis.
Deferred tax assets are not
recognised due to uncertainty concerning
crystallisation.
Payroll expense and related
contributions
Wages, salaries, payroll tax, paid
annual leave and sick leave, bonuses, and non-monetary benefits are
accrued in the period in which the associated services are
rendered.
Pension costs
The Group makes contributions to
the private pension schemes of Directors and employees.
Contributions are recognised in the periods to which they
relate.
Share-based compensation
The Group issues share based
payments to certain employees and Directors and warrants have been
issued to certain suppliers. Equity- settled share-based payments
are measured at fair value at the date of grant and expensed on a
straight-line basis over the vesting period, along with a
corresponding increase in equity.
At each reporting date, the Group
revises its estimate of the number of equity instruments expected
to vest as a result of the effect of non-market based vesting
conditions. The impact of any revision is recognised in the
Consolidated Statement of Comprehensive Income, with a
corresponding adjustment to equity reserves.
The fair value of share options
and warrants are determined using a Black-Scholes model, taking
into consideration the best estimate of the expected life of the
option or warrant and the estimated number of shares that will
eventually vest.
Operating
segments
Operating segments are reported in a manner
consistent with the internal reporting provided to the chief
operating decision-maker. The chief operating decision-maker is
responsible for allocating resources and assessing performance of
operating segments.
The Directors consider that there are no
identifiable business segments that are subject to risks and
returns different to the core business. The information reported to
the Directors, for the purposes of resource allocation and
assessment of performance is based wholly on the overall activities
of the Group. The Group has therefore determined that it has only
one reportable segment under IFRS 8.
The results and assets for this segment can be determined by reference to the
Consolidated Statement of Comprehensive Income and Consolidated
Statement of Financial
Position.
Investment in
subsidiaries
Investment in subsidiaries is
shown in the Company Statement of Financial Position at cost and
are reviewed annually for
impairment.
Financial
instruments
Financial assets and financial
liabilities are recognised in the Group's Consolidated Statement of
Financial Position when the Group becomes party to the contractual
provisions of the instrument. Financial assets are derecognised
when the contractual rights to the cash flows from the financial
asset expire or when the contractual rights to those assets are
transferred. Financial liabilities are derecognised when the
obligation specified in the contract is discharged, cancelled or
expired.
Trade and
other receivables
Trade and other receivables that
do not contain a significant financing component are initially
recognised at fair value and subsequently held at amortised cost
less provision for impairment. Provisions for impairment are based
on an expected credit loss model as required by IFRS
9.
Cash, cash equivalents and short-term
investments
Cash and cash equivalents consist
of cash on hand, demand deposits, and other short-term highly
liquid investments that are readily convertible to a known amount
of cash and are subject to an insignificant risk of changes in
value.
Trade and other payables
Trade and other payables are not
interest-bearing and are stated at nominal value.
Classification as debt or equity
Debt and equity instruments issued
by the Group are classified as either financial liabilities or as
equity in accordance with the substance of the contractual
arrangements and the definitions of a financial liability and an
equity instrument.
Equity instruments
An equity instrument is any
contract that evidences a residual interest in the assets of an
entity after deducting all its liabilities. Equity instruments
issued by the Group are recognised as the proceeds received, net of
direct issue costs.
Capital risk management
The Group has been funded by
equity. The components of shareholders' equity
are:
(a) The share capital and share
premium account arising on the issue of shares.
(b) Merger reserve, which was
created as a result of the acquisition by the Company of the entire
issued share capital of BiVictriX Limited on 9 August
2021.
(c) The share-based compensation
reserve results from the Group's grant of equity-settled share
options to selected employees and Directors.
(d) The retained deficit
reflecting comprehensive loss to date.
The Group's objective when
managing capital is to maintain adequate financial flexibility to
preserve its ability to meet financial obligations, both current
and long term. The capital structure of the Group is managed and
adjusted to reflect changes in economic conditions. The Group funds
its expenditures on commitments from existing cash and cash
equivalent balances, primarily received from issuances of
shareholders' equity. There are no externally imposed capital
requirements. Financing decisions are made based on forecasts of
the expected timing and level of capital and operating expenditure
required to meet the Group's commitments and development
plans.
Fair value estimation
The carrying value less impairment
provision of trade receivables and payables are assumed to
approximate their fair values because of the short-term nature of
such assets and the effect of discounting liabilities is
negligible.
Significant management judgement in applying accounting
policies and estimation uncertainty
When preparing the financial
statements, the Directors make estimates and assumptions about the
recognition and measurement of assets, liabilities, income and
expenses during the reporting period.
Estimates and judgements are
continually evaluated and based on historical experience and other
factors, including expectations of future events that are believed
to be reasonable under the circumstance.
The following are the significant
judgements and estimates used in applying the accounting policies
of the Company.
Estimation uncertainty
Receivables from the subsidiary,
being amounts due from BiVictriX Limited advanced to support the
Group's research expenditure, will be recoverable from future
commercial revenues or capital receipts in the subsidiary, which
are not certain to arise. As at 31 December 2023 the
receivable balance from the subsidiary was £7.0 million (2022: £5.4
million).
Treatment of research and development
expenditure
Expenditure on pure and applied
research is charged to the profit and loss account in the year in
which it is incurred. Development costs are charged to profit and
loss account unless it can be demonstrated that the costs represent
an intangible asset which meets all the criteria for capitalisation
set out in para 57 of IAS38. As BiVictriX's lead
programme is in the early stages of clinical development, all costs
are expenses to the income statement.
Taxation
In recognising income tax assets
and liabilities, management makes estimates of the likely outcome
of decisions by tax authorities on transactions and events whose
treatment for tax purposes is uncertain. In particular, amounts
claimed for R&D tax credits may not be receivable. The balance
recoverable is only confirmed at the point the claim is approved by
the tax authority. The calculation is consistent with prior periods
where claims have been approved and external tax advisors review
the submission. Where the outcome of such matters is different, or
expected to be different, from previous assessments made by
management, a change to the carrying value of income tax assets and
liabilities will be recorded in the period in which such a
determination is made. The carrying values of current tax are
disclosed separately in the statement of financial
position. As at 31 December 2023 the expected R&D tax
credits claimable for the period was £0.4 million (2022: £0.5
million).
3. Operating Loss
An
analysis of the Group's operating loss has been arrived at after charging:
|
Year ended
31 Dec
2023
|
Year ended
31 Dec
2022
|
|
£'000
|
£'000
|
Research and
development:
|
|
|
Other research and
development
|
1,058
|
1,237
|
Staff
costs (see note 5)
|
824
|
722
|
Depreciation of
property, plant and equipment
|
165
|
151
|
General and Administrative:
|
|
|
Staff
costs (see note 5)
|
320
|
314
|
Administration expenses
|
584
|
424
|
Share based
compensation
|
74
|
127
|
Total operating expenses
|
3025
|
2,975
|
The Group has one reportable
segment, namely the development of pharmaceutical products all
within the United Kingdom.
4. Auditor's Remuneration
The analysis of the auditor's remuneration is as follows:
|
Year ended
31 Dec
2023
|
Year ended
31 Dec
2022
|
|
£'000
|
£'000
|
Fees payable to the Group's auditors for the audit of:
|
|
|
the
annual accounts
|
43
|
38
|
Total audit
fees
|
43
|
38
|
Audit related services
|
4
|
4
|
Total audit
related fees
|
47
|
42
|
Other services
|
-
|
-
|
Total non-audit fees
|
-
|
-
|
5.
Employees and Directors
The average monthly number of persons (including Executive
Directors) employed by the Group was:
|
Group
|
Company
|
|
Year ended
31 Dec
2023
Number
|
Year
ended
31
Dec
2022
Number
|
Year ended
31 Dec
2023
Number
|
Year
ended
31
Dec
2022
Number
|
Directors
|
5
|
6
|
5
|
6
|
Scientists and administration
staff
|
12
|
10
|
-
|
-
|
Average total persons employed
|
17
|
16
|
5
|
6
|
At 31 December 2023 the Group had
17 employees (31 December 2022: 16).
Staff costs in respect of these employees were:
|
Group
|
|
|
Year ended
31 Dec
2023
£'000
|
Year ended
31 Dec
2022
£'000
|
Salaries and other
short-term employee
benefits
|
967
|
899
|
Employer's
National Insurance
|
106
|
102
|
Pension contributions
|
71
|
35
|
Options
vesting under share option schemes
|
86
|
127
|
Total remuneration including vesting of share options
|
1,230
|
1,163
|
|
|
| |
The Group makes
contributions to pension schemes on behalf of the Director and
employees.
The total remuneration
of the highest paid Director excluding share-based payments was
£226,375 (31 December 2022: £212,950).
The Directors have the
authority and responsibility for planning, directing and
controlling, directly or indirectly, the activities of the Group
and they therefore comprise key management personnel as defined by
IAS 24.
Aggregate emoluments of the Directors of BiVictriX Therapeutics
plc:
|
Group
|
|
Year ended
31 Dec
2023
|
Year ended
31 Dec
2022
|
|
£'000
|
£'000
|
|
|
|
Salaries and other
short-term employee
benefits
|
415
|
375
|
Employer's
National Insurance
|
44
|
38
|
Pension contributions
|
12
|
8
|
Options
vesting under share option schemes
|
62
|
106
|
Total remuneration including vesting of share options
|
533
|
527
|
6. Taxation
|
Year ended
31 Dec
2023
£'000
|
Year ended
31 Dec
2022
£'000
|
Current tax
|
|
|
Research and development income tax credit
receivable
|
396
|
454
|
Adjustments in
respect of prior periods
|
62
|
20
|
Net tax credit
|
458
|
474
|
Deferred income tax
|
|
|
Deferred tax asset from share based
payments
|
88
|
-
|
Deferred tax liability from accelerated
capital allowances
|
(88)
|
66
|
Net deferred taxes
|
-
|
66
|
The Group has a deferred tax
liability being accelerated capital allowances, for which the tax,
measured at a standard rate of 25% (2022: 19%) in all periods is 31
December 2023 £87,501 (2022: £262).
The Group has a deferred tax asset
for share-based payments, for which the tax, measured at a standard
rate of 25% in all periods is 31 December 2023 £87,501 (2022:
£66,000). No deferred tax assets have been recognised due to the
uncertainty of the availability of future profits.
At 31 December 2023
the Group had UK carried forward tax losses of £5.1 million (2022:
£3.7 million). A deferred tax asset has been recognised in respect
of these losses to the extent of the accelerated capital allowances
within the group. No deferred tax asset has been recognised
in respect of the carried forward losses over and above the group's
deferred tax liabilities due to the uncertainty of the availability
of future profits.
The tax credit
for each period can be reconciled
to the
loss per Consolidated Statement of Comprehensive Income as follows:
|
Year ended
31 Dec
2023
£'000
|
Year ended
31 Dec
2022
£'000
|
Loss
on ordinary activities before taxation
|
(3,003)
|
(2,971)
|
Loss
before
tax at
the effective
rate of corporation tax in the United Kingdom of 23.52% (2022 19%)
|
(706)
|
(566)
|
Effects of:
|
|
|
Fixed asset differences
|
-
|
(15)
|
Expenses not deductible for tax
purposes
|
20
|
59
|
Additional deduction for R&D
expenditure
|
(316)
|
(336)
|
Surrender of tax losses for R&D tax credit
refund
|
642
|
596
|
Movement in deferred tax not
recognised
|
411
|
262
|
Adjustment to tax charge in respect of
previous periods
|
(62)
|
(20)
|
Remeasurement of deferred tax for changes in
tax rates
|
(33)
|
-
|
Timing differences not recognised
in the computation
|
(18)
|
|
R&D tax credit
|
(396)
|
(454)
|
Tax credit
for the year
|
(458)
|
(474)
|
7. 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.
For diluted loss per share, the
loss for the year attributable to equity holders and the weighted
average number of ordinary shares outstanding during the year is
adjusted to assume conversion of all dilutive potential ordinary
shares.
As at 31 December 2023, the Group
had 8,744,184 (2022: 8,734,184)
share options outstanding.
The calculation of the Group's
basic and diluted loss per share is based on the following
data:
|
Year ended
31 Dec
2023
£'000
|
Year ended
31 Dec
2022
£'000
|
Loss for the year attributable to
equity holders for basic loss and adjusted for the effects of
dilution
|
(2,545)
|
(2,497)
|
|
Year ended
31 Dec
2023
|
Year ended
31 Dec
2022
|
Weighted average
number
of ordinary shares for basic loss per share
|
72,645,075
|
66,115,171
|
Effects
of dilution:
|
-
|
-
|
Share options
|
|
|
Weighted average
number
of ordinary shares adjusted for the effects of dilution
|
72,645,075
|
66,115,171
|
|
Year ended
31 Dec
2023
£'000
|
Year ended
31 Dec
2022
£'000
|
Loss
per share - basic and diluted
|
(3.50)
|
(3.78)
|
The loss and the weighted average
number of ordinary shares for the years ended 31 December 2023 and
2022 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.
8. Property,
Plant and
Equipment
|
Office
equipment, fixtures and fittings
|
Building
improvements
|
Plant
and machinery
|
Motor
Vehicles
|
Right of
Use Asset
|
Total
|
|
£'000s
|
£'000s
|
£'000s
|
£'000s
|
£'000s
|
£'000s
|
Cost
|
|
|
|
|
|
|
At 31 December 2022
|
17
|
5
|
319
|
4
|
423
|
768
|
Adjustment to opening balance
|
-
|
-
|
2
|
-
|
(162)
|
(160)
|
Additions
|
2
|
-
|
3
|
-
|
160
|
165
|
Disposals
|
-
|
-
|
-
|
(4)
|
-
|
(4)
|
At 31 December
2023
|
19
|
5
|
324
|
-
|
421
|
769
|
|
|
|
|
|
|
|
Accumulated
Depreciation
|
|
|
|
|
|
|
At 31 December 2022
|
6
|
2
|
58
|
-
|
131
|
197
|
Adjustment to opening balance
|
-
|
-
|
-
|
-
|
(69)
|
(69)
|
Provided during the year
|
4
|
1
|
55
|
-
|
105
|
165
|
Disposals
|
-
|
-
|
-
|
-
|
-
|
-
|
At 31 December
2023
|
10
|
3
|
113
|
-
|
167
|
293
|
|
|
|
|
|
|
|
Net Book
Value
|
|
|
|
|
|
|
At 31 December 2022
|
11
|
3
|
261
|
4
|
292
|
571
|
At 31 December
2023
|
9
|
2
|
211
|
-
|
254
|
476
|
Depreciation is
charged to operating expenses.
|
Office
equipment, fixtures and fittings
|
Building
improvements
|
Plant
and machinery
|
Motor
Vehicles
|
Right of
Use Asset
|
Total
|
|
£'000s
|
£'000s
|
£'000s
|
£'000s
|
£'000s
|
£'000s
|
Cost
|
|
|
|
|
|
|
At 31 December 2021
|
12
|
3
|
97
|
-
|
275
|
387
|
Additions
|
5
|
2
|
229
|
4
|
148
|
388
|
Disposals
|
-
|
-
|
(7)
|
-
|
-
|
(7)
|
At 31 December
2022
|
17
|
5
|
319
|
4
|
423
|
768
|
|
|
|
|
|
|
|
Accumulated
Depreciation
|
|
|
|
|
|
|
At 31 December 2021
|
2
|
1
|
16
|
-
|
29
|
48
|
Provided during the year
|
4
|
1
|
43
|
-
|
102
|
150
|
Disposals
|
-
|
-
|
(1)
|
-
|
-
|
(1)
|
At 31 December
2022
|
6
|
2
|
58
|
-
|
131
|
197
|
|
|
|
|
|
|
|
Net Book
Value
|
|
|
|
|
|
|
At 31 December 2021
|
10
|
2
|
81
|
-
|
246
|
339
|
At 31 December
2022
|
11
|
3
|
261
|
4
|
292
|
571
|
9. Investment
in Subsidiary Undertakings
The consolidated
financial statements of the Group at 31 December 2023
include:
Name
of subsidiary
|
Class of share
|
Place of incorporation
|
Principle activities
|
Proportion of ownership interest
|
Proportion of voting rights held
|
BiVictriX Limited
|
Ordinary
|
United Kingdom
|
Research and
development
|
100%
|
100%
|
|
Company
|
|
2023
£'000
|
2022
£'000
|
Cost at 1 January
|
214
|
214
|
Acquisitions during the year
|
-
|
-
|
Cost at 31 December
|
214
|
214
|
Carrying Value as at
31 December
|
214
|
214
|
|
Company
|
Break down of
carrying
value of
investment:
|
2023
£'000
|
2022
£'000
|
BiVictriX Limited -
equity
|
214
|
214
|
BiVictriX Limited -
loan
|
6,826
|
5,173
|
|
7,040
|
5,387
|
Investments are tested for
impairment at the reporting date. No impairment loss was
recognised.
10. Trade
and Other Receivables
|
Group
|
Company
|
|
As at
31 Dec
2023
£'000
|
As
at
31 Dec
2022
£'000
|
As at
31 Dec
2023
£'000
|
As
at
31 Dec
2022
£'000
|
Amounts receivable within one year
|
|
|
|
|
Other taxation and social security
|
58
|
111
|
11
|
32
|
Prepayments
|
86
|
113
|
37
|
42
|
Trade and
other receivables
|
144
|
224
|
48
|
74
|
The Directors believe that the
carrying value of trade and other receivables represents their fair
value. In determining the recoverability of trade receivables, the
Group considers any change in the credit quality of the receivable
from the date credit was granted up to the reporting date. In
addition, an expected credit losses model is used which broadens
the information that an entity is required to consider when
determining its expectations of impairment. Under this model,
expectations from future events are considered which could result
in the earlier recognition of impairments. Details on the Group's
credit risk management policies are shown in Note 16. The Group
does not hold any collateral as security for its trade and other
receivables.
Amounts due to the
Company from subsidiary undertakings are not considered to be
receivable within one year - see notes 17 and
18.
11. Cash,
Cash Equivalents and Short-Term Investments
|
Group
|
Company
|
|
Year ended
31 Dec
2023
£'000
|
Year
ended
31 Dec
2022
£'000
|
Year ended
31 Dec
2023
£'000
|
Year
ended
31 Dec
2022
£'000
|
Cash in bank and in hand
|
3,279
|
3,287
|
3,126
|
3,002
|
12. Trade
and Other Payables
|
Group
|
Company
|
|
Year ended
31 Dec
2023
£'000
|
Year ended
31 Dec
2022
£'000
|
Year ended
31 Dec
2023
£'000
|
Year ended
31 Dec
2022
£'000
|
|
Amounts falling due within one year
|
|
|
|
|
|
Trade payables
|
209
|
112
|
8
|
-
|
|
Other taxation and social security
|
42
|
40
|
-
|
-
|
|
Accrued
expenses
|
245
|
132
|
66
|
43
|
|
Trade and
other payables
|
496
|
284
|
74
|
43
|
|
Trade and other payables
principally consist of amounts outstanding for trade purchases and
ongoing costs. They are non-interest bearing and are normally
settled on 30 to 45 day terms. The Directors consider that the
carrying value of trade and other payables approximates to their
fair value. All trade and other payables are denominated in
Sterling. The Group has financial risk management policies in place
to ensure that all payables are paid within the credit timeframe
and no interest has been charged by any suppliers because of late
payment of invoices during the period.
The fair value of trade and other payables approximates to their current book
values.
13. Issued Capital and Reserves
Ordinary shares
|
Company
|
Ordinary shares of 1p
each:
|
Number
|
Share
Capital
|
Share
Premium
|
Total
|
|
|
£'000
|
£'000
|
£'000
|
At 31 December 2022
|
66,115,171
|
661
|
12,052
|
12,713
|
Prior period adjustment
|
30
|
-
|
-
|
-
|
Issued of share capital
|
16,410,887
|
164
|
1,969
|
2,133
|
Expenses of share issue
|
-
|
-
|
(82)
|
(82)
|
At 31 December 2023
|
82,526,088
|
825
|
13,939
|
14,764
|
The prior period adjustment
relates to 30 shares which were incorrectly omitted from the prior
year balance.
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 reserve at 31
December 2023 arose from the acquisition of
BiVictriX Limited on 9 August 2021, which is accounted for using
the merger method of accounting.
The share-based compensation
reserve reflects the cumulative expense for
outstanding share based instruments.
Reserves classified as retained
deficit represent accumulated losses. None of the reserves are
distributable.
14. Share-based Payments
Certain Directors and employees of the Group
are granted options to subscribe for shares in the Group in
accordance with the rules of the Company's share option schemes.
The number of shares subject to options, the periods in which they
were granted and the period in which they may be exercised are
given below.
As at 31 December 2023,, the Group operated
one share option scheme. Options are currently granted
for £nil consideration and are exercisable at a price determined on
the date of the grant.
At 31 December 2023 the Company had 8,744,184
(2022: 8,734,184) unissued ordinary shares of 1p under the
Company's share option schemes, details of which are as
follows:
Exercise
price
|
At 1 Jan 2023
|
Granted
|
Lapsed
|
At
31 Dec 2023
|
Date from
which
exercisable
|
Expiry
date
|
0.150
|
-
|
33,333
|
10,000
|
23,333
|
10 May
2024
|
10 May
2033
|
0.150
|
-
|
33,333
|
10,000
|
23,333
|
10 May
2025
|
10 May
2033
|
0.150
|
-
|
33,334
|
10,000
|
23,334
|
10 May
2026
|
10 May
2033
|
0.250
|
156,056
|
-
|
10,000
|
146,056
|
13 Dec
2022
|
13 Dec
2032
|
0.250
|
156,056
|
-
|
10,000
|
146,056
|
13 Dec
2023
|
13 Dec
2032
|
0.250
|
156,056
|
-
|
10,000
|
146,056
|
13 Dec
2024
|
13 Dec
2032
|
0.250
|
10,000
|
-
|
10,000
|
-
|
3 May
2023
|
3 May
2032
|
0.250
|
10,000
|
-
|
10,000
|
-
|
3 May
2024
|
3 May
2032
|
0.250
|
10,000
|
-
|
10,000
|
-
|
3 May
2025
|
3 May
2032
|
As
at 31 December
2023, the share option scheme movements was as follows:
|
As
at 31 Dec 2023
|
As at
31 Dec 2022
|
|
Number
|
Weighted average exercise price Pence
|
Number
|
Weighted average exercise price Pence
|
Outstanding at
start of the year
|
8,734,184
|
20.16
|
8,614,184
|
2016
|
Granted
|
100,000
|
15.00
|
120,000
|
20.17
|
Lapsed
|
(90,000)
|
20.07
|
-
|
-
|
Outstanding at end of year
|
8,744,184
|
20.11
|
8,734,184
|
20.16
|
Exercisable at end
of year
|
4,522,500
|
20.10
|
4,900,677
|
19.54
|
The fair
values of share options granted during the period were calculated
using the Black Scholes option pricing model. The inputs into the
model for awards granted were as follows:
Options issued
|
100,000
|
Grant date
|
10 May
2023
|
Expiry date
|
10 May
2033
|
Vesting period
|
One
third each year from grant
|
Share price (pence)
|
15.0p
|
Exercise price (pence)
|
15.0p
|
Expected volatility
|
48.00%
|
Risk free rate
|
3.46%
|
Fair value of options
granted
|
£3,002
|
15. Lease liabilities
Amounts recognised in the
statement of financial position
Right-of-use
assets
Details of the
Right-of-use assets held at 31 December 2023 can be found in note
8.
Lease
liabilities
|
As at 31 Dec
2023
|
As at 31
Dec 2022
|
|
£'000
|
£'000
|
Current
|
128
|
107
|
Non-current
|
134
|
188
|
|
262
|
295
|
Future minimum lease payments are
as follows:
|
|
|
Not later than one year
|
128
|
107
|
Later than one year and not later
than 5 years
|
134
|
188
|
Total gross payments
|
262
|
295
|
Impact of finance
expenses
|
-
|
-
|
Carrying amount of liability
|
262
|
295
|
Adjustments have been made to reflect the
recalculation of prior period cost and accumulated depreciation of
Right of Use assets (see note 8) and to reduce the opening balance
on lease liabilities accordingly.
Lease liabilities have been recognised on the
incremental borrowing rate for Land and Buildings and Office
Equipment.
Amounts
recognised in the statement of comprehensive
income
|
As
at
31 Dec 2023
|
As
at
31 Dec 2022
|
|
£'000
|
£'000
|
Depreciation charge
|
(105)
|
(103)
|
Interest on lease
liabilities
|
(14)
|
(12)
|
Rental payments with lease term
less than 12 months
|
|
-
|
|
(119)
|
(115)
|
Amounts
recognised in the statement of cash flows
|
As at
31 Dec
2023
|
As
at
31 Dec
2022
|
|
£'000
|
£'000
|
Principal elements of lease
payments
|
(102)
|
(75)
|
Interest on lease
liabilities
|
(14)
|
-
|
Rental payments with lease term
less than 12 months
|
-
|
-
|
|
(116)
|
(75)
|
16. Financial
Risk Management
The main risks arising from the
Group's financial instruments are cash flow and liquidity and
credit risk. The Group's financial instruments comprise
cash and various items such as trade
payables, which arise directly from its
operations.
Cash flow and
liquidity risk
Management monitors the level
of cash on a regular basis to ensure
that the Group has sufficient funds to meet its commitments where
due. The table below analyses the Group and Company's financial
liabilities by category:
|
|
|
|
|
|
|
Group
|
Company
|
|
|
Year ended 31 Dec 2023 Financial
assets at
amortised
cost
£'000
|
Year
ended 31 Dec 2022 Financial
assets
at amortised Cost
£'000
|
Year ended 31 Dec 2023 Financial
assets at
amortised
cost
£'000
|
Year
ended 31 Dec 2022 Financial
assets
at amortised
cost
£'000
|
|
|
|
|
|
|
Trade payables
|
209
|
112
|
8
|
-
|
|
|
|
|
|
|
|
Other creditors and accruals
|
287
|
172
|
66
|
43
|
|
|
496
|
284
|
74
|
43
|
|
|
|
|
|
|
|
|
|
|
|
|
|
All liabilities are due within 30
days except for lease liabilities
which are dealt with in note 15.
Credit
risk
The Group considers which
organisations it uses for banking in order
to minimise credit risk. The Group holds cash with one large bank
in the UK. The amounts of cash held at the reporting date can be
seen in the financial assets table above. All of the cash and
equivalents were denominated in UK Sterling. The Group's policy is
to minimise the risks associated with cash
and cash equivalents by placing these deposits with institutions
with a recognised high credit rating.
The carrying amount of financial
assets recorded in the Consolidated
Statement of Financial Position, net of any allowances for losses,
represents the Group's maximum exposure to credit risk without
taking account of the value of any collateral
obtained.
No allowance has been
made for impairment losses. In the
Directors' opinion, there has been no impairment of financial
assets during the period.
An allowance for impairment
is made where there is an identified
credit loss which, based on previous experience, is evidence of a
reduction in the recoverability of the cash flows. The Directors
consider the above measures to be sufficient to control the credit
risk exposure. No collateral is held by the Group as security in
relation to its financial assets.
Foreign
currency risk
The Group's exposure to the risk
of changes in foreign exchange rates relates solely to the Group's
use of suppliers operating overseas, primarily
denominated in Euros and US Dollars. The Group's
use of foreign suppliers is minimal and as such exposure to foreign
currency changes is not material.
The carrying amounts
of the Group's foreign currency
denominated monetary assets and monetary liabilities at the year
end were £164,000 (2022: £16,000).
At present the Group does not make
use of financial instruments to minimise any foreign exchange gains
or losses so any fluctuations in foreign exchange movements may have a material adverse impact on the
results from operating activities.
Fair
value of financial assets and liabilities
There is no material difference
between the fair value and the carrying values of the financial
instruments because of the short maturity period of these financial
instruments and their intrinsic size and risk.
Capital
risk management
The Group considers capital to be
shareholders' equity as shown in the consolidated statement of
financial position, as the Group is primarily
funded by equity finance. The Group is not yet in
a position to pay a dividend.
The objectives when managing
capital are to safeguard the Group's ability to continue as a going
concern in order to provide returns for shareholders and for other
stakeholders. In order to maintain or adjust the capital structure
the Group may return capital to shareholders and issue new
shares.
17. Related Party Transactions
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 is
disclosed in Note 5.
18.
Transactions with shareholders
The following transactions with
shareholders and companies controlled by directors or former
directors of BiVictriX were recorded, excluding VAT, during the
year:
|
|
Year to 31 Dec
2023
|
Year to 31 Dec
2022
|
|
|
£'000
|
£'000
|
HAD Consulting (Michael Kauffman)
|
|
|
Consultancy fees
|
|
2
|
-
|
|
|
|
| |
Company
The Company is responsible for financing and
setting Group strategy. The Company's subsidiary carried out the
Group's research and development strategy including the management
of the Group's intellectual property. The Company provides funding
to its subsidiary in the form of a loan. This loan is classified as
non-current to reflect the likely repayment schedule of the loan.
Balance outstanding, at the 31 December 2023 was £6.8 million (31
December 2022: £5.2 million).
19. Contingent Liabilities
The Group has no contingent
liabilities at 31 December 2023 (2022: nil).
20. Events after the Reporting Date
There are no events after the reporting date
to disclose.
21. Ultimate Controlling Party
There is no ultimate controlling
party of the Group.