REG - BiVictriX Therapcts. - BiVictriX – Full Year Results 2023
31/05/2024 08:45
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RNS Number : 6353Q BiVictriX Therapeutics PLC 31 May 2024
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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, Tel: +44 (0) 20 3709 5700
Max Bennett, Emmalee Hoppe, Dylan Wilks 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
(http://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
(#_ftn1) 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
(https://businesscloud.co.uk/medtech-50-uks-most-innovative-medical-technology-creators/)
, 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
Year Ended Year Ended
31 December 2023 31 December 2022
Notes
£'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 (2,545) (2,497)
parent for the year
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
As at As at As at As at
31 December 2023 31 December 2022 31 December 2023 31 December 2022
£'000 £'000 £'000 £'000
Notes
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 - - 127 - - 127
o options op options
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 Year ended 31 December 2022 Year ended 31 December 2023 Year ended 31 December 2022
£'000 £'000 £'000 £'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 Year ended
31 Dec 31 Dec
2023 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 Year ended
31 Dec 31 Dec
2023 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 Year ended Year ended Year ended
31 Dec 31 Dec 31 Dec 31 Dec
2023 2022 2023 2022
Number Number Number 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 Year ended
31 Dec 31 Dec
2023 2022
£'000 £'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 Year ended
31 Dec 31 Dec
2023 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 Year ended
31 Dec 31 Dec
2023 2022
£'000 £'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 Year ended
31 Dec 31 Dec
2023 2022
£'000 £'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 (706) (566)
of 23.52% (2022 19%)
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 Year ended
31 Dec 31 Dec
2023 2022
£'000 £'000
Loss for the year attributable to equity holders for basic loss and adjusted (2,545) (2,497)
for the effects of dilution
Year ended Year ended
31 Dec 31 Dec
2023 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 72,645,075 66,115,171
dilution
Year ended Year ended
31 Dec 31 Dec
2023 2022
£'000 £'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 2022
£'000 £'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 2022
£'000 £'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 As at As at As at
31 Dec 31 Dec 31 Dec 31 Dec
2023 2022 2023 2022
£'000 £'000 £'000 £'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 Year ended Year ended Year ended
31 Dec 31 Dec 31 Dec 31 Dec
2023 2022 2023 2022
£'000 £'000 £'000 £'000
Cash in bank and in hand 3,279 3,287 3,126 3,002
12. Trade and Other Payables
Group Company
Year ended Year ended Year ended Year ended
31 Dec 31 Dec 31 Dec 31 Dec
2023 2022 2023 2022
£'000 £'000 £'000 £'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
Number Share Capital Share Premium Total
Ordinary shares of 1p each:
£'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 Granted Lapsed At Date from which exercisable Expiry
1 Jan 2023 31 Dec 2023 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 As at
31 Dec 2023 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 Year ended 31 Dec 2022 Financial assets at amortised Cost Year ended 31 Dec 2023 Financial assets at amortised cost Year ended 31 Dec 2022 Financial assets at amortised
cost
£'000 £'000 £'000
£'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.
1 (#_ftnref1) Roohi Mariam Peter, "M&As: what's up with the ADC buying
spree?," Labiotech.eu, 20 November 2023,
https://www.labiotech.eu/trends-news/antibody-drug-conjugates-investment-surge/
(https://www.labiotech.eu/trends-news/antibody-drug-conjugates-investment-surge/)
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