REG - BiVictriX Therapcts. - Interim Results
19/09/2023 07:00
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RNS Number : 8150M BiVictriX Therapeutics PLC 19 September 2023
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BIVICTRIX THERAPEUTICS PLC
("BiVictriX" or "the Company" or "the Group")
Interim results for the six months ended 30 June 2023
Alderley Park, 19 September 2023 - BiVictriX Therapeutics plc (AIM: BVX), an
emerging biotechnology company applying a differentiated approach to develop
novel, next-generation anti-cancer precision Antibody Drug Conjuagtes,
offering substantially improved cancer cell selectivity and therapeutic
activity, today announces its unaudited interim results for the six months
ended 30 June 2023.
Highlights, including post period:
· Nomination of a clinical candidate for the lead programme, BVX001
following compelling and differentiated in vivo efficacy and toxicity data in
three preclinical models of Acute Myeloid Leukaemia ("AML"), including studies
comparing BVX001 to the clinical comparator Mylotarg™. Further pre-IND
studies are ongoing.
· Continued progression of the BVX002 and BVX003 programmes to broaden
our therapeutic pipeline and further evaluate our proprietary approach's
utility in targeting multiple solid tumour indications.
· Further development of the Bi-Cygni® platform to provide BiVictriX
with diverse opportunities to pursue commercial partnerships.
· Cash and cash equivalents of £1.9 million at 30 June 2023, bolstered
post period end by an R&D tax credit payment of £0.5 million.
· Successful placing which raised gross proceeds of £2.1 million from
existing and new investors.
· Appointment of Dr. Michael Kauffman, M.D., Ph.D. as Non-Executive
Chairman, providing BiVictriX with over two decades of executive experience
working across preclinical research, clinical development, regulatory strategy
and commercialisation, including global approvals of several oncology
therapeutics.
· Granted US patent providing broad protection for BVX001 through to
2039. We anticpate that this patent will also be granted in Japan in the
forthcoming weeks, providing a strong IP position in these two key global
markets and we are pursuing prosecution for this patent family in a further
six global jurisdictions to provide BiVictriX with protection for our lead
therapeutic asset, at the broadest level, across all relevant markets.
Tiffany Thorn, Chief Executive Officer of BiVictriX Therapeutics plc,
commented: "Over the past six months, BiVictriX has made significant
advancements in executing its strategy, both during and after the reporting
period. The Company's leading clinical candidate, BVX001, has exhibited
positive pre-clinical results across three in vivo studies, reinforcing the
potential for improved efficacy and superior cancer selectivity of our
Bi-Cygni® approach over existing AML agents. This further strengthens our
data package to support the progression of BVX001 into the clinic for patients
with challenging-to-treat cancers. Our plans are bolstered by £2.1 of million
new investment. In addition to this, the Company has fortified its
intellectual property protection by obtaining broad patent protection for
BVX001 in the United States and has applied for patents in seven other
jurisdictions to create a robust patent protected portfolio."
For more information, please contact:
BiVictriX Therapeutics plc
Tiffany Thorn, Chief Executive Officer Email: info@bivictrix.com (mailto:info@bivictrix.com)
Michael Kauffman, Non-Executive Chairman
SP Angel Corporate Finance LLP (NOMAD and Broker)
David Hignell, Kasia Brzozowska (Corporate Finance)
Vadim Alexandre, Rob Rees (Sales and Broking) Tel: +44 (0) 20 3470 0470
Panmure Gordon (UK) Limited (Joint Broker)
Rupert Dearden/Freddy Crossley/Emma Earl
Tel: +44 (0) 20 7886 2500
ICR Consilium
Mary-Jane Elliott, Namrata Taak, Max Bennett, Emmalee Hoppe Tel: +44 (0) 20 3709 5700
Email: Bivictrix@consilium-comms.com (mailto:Bivictrix@consilium-comms.com)
About BiVictriX Therapeutics plc
BiVictriX (AIM: BVX) is an emerging biotechnology company leveraging clinical
experience and its proprietary discovery engine to advance a new class of
highly cancer-selective, next-generation precision cancer therapies in one of
the fastest-growing markets in oncology. BiVictriX's first-in-class Bi-Cygni®
Antibody Drug Conjugates ("ADCs") combine superior efficacy with substantially
improved cancer-selectivity and safety to provide opportunities for prolonged
dosing and greater efficacy in the clinic. The Company is advancing its
pipeline to deliver the future of cancer care across a broad range of
haematological and solid cancer indications in areas of high unmet medical
need.
Find out more at www.bivictrix.com (http://www.bivictrix.com/) and connect
with us on LinkedIn
(https://www.linkedin.com/company/bivictrix-therapeutics-plc/) and
Twitter @BiVictriX (https://twitter.com/BiVictriX) .
Chairman's Statement
I was honoured to join BiVictriX as a Non-Executive Director in January 2022
and have seen first-hand the significant progress made in the Company's
pipeline and corporate development. I am now pleased to be reporting, for the
first time in my role as Non-Executive Chairman, our most recent progress as
we continue to grow and mature into an established biotech company.
Since the Company was founded in 2017 and with our subsequent AIM listing in
2021, our team has been working tirelessly to maintain the strong momentum we
have achieved, and we remain focused on advancing our proprietary pipeline of
safer and more effective cancer-targeted Antibody Drug Conjugates ("ADCs")
towards the clinic. Our approach to revolutionise cancer therapy focuses on
delivering the next-generation of precision cancer therapeutics that target
the cancer cells, not the patient's normal cells. This profile results in
improved safety and higher treatment doses for prolonged periods of time in
one of the fastest-growing markets in oncology. This unique approach is made
possible by our proprietary Bi-Cygni® platform, which has enabled us to
combine novel cancer-specific twin antigen fingerprints, identified through
our discovery engine, with a unique ADC therapeutic design, allowing us to
deliver first-in-class bispecific ADCs with superior cancer-selectivity and
efficacy. Utilising the Bi-Cygni® platform, we are building a robust pipeline
of next-generation ADCs with improved safety and efficacy across a wide range
of solid tumour and haematological cancers. This broad platform provides
BiVictriX with opportunities to pursue and secure preclinical partnership
deals, as part of the Company's growth strategy.
Our primary focus during this period has been on advancing our lead asset,
BVX001, which targets Acute Myeloid Leukaemia ("AML"), the most aggressive
form of adult leukaemia linked to dismal survival rates. During the period we
reported positive pre-clinical results across three in vivo studies, further
strengthening our data package to support the progression of BVX001 into the
clinic. Firstly, we received positive in vivo safety data in a humanised
murine model assessing bone marrow toxicity. The study indicated that BVX001
is not only well-tolerated, but also did not show any evidence of significant
bone marrow toxicity - that is, markedly reduced infection-fighting white
blood cells, or neutrophils - when compared to typical chemotherapies as well
as Mylotarg™, the only approved ADC for AML. This finding is particularly
significant, as nearly all AML therapies are associated with significantly
reduced levels of normal neutrophils, which can lead to a condition known as
neutropenic sepsis, one of the leading causing of hospitalisation and death in
this patient group.
The positive in vivo safety data was followed by strong in vivo efficacy
data from two studies conducted in AML murine models. In the first,
significant tumour regressions of up to 93% at day 28 were observed with no
apparent adverse effects. These results led to a clinical candidate
nomination for BVX001. In the second preclinical study, of which full results
were received post period, we assessed the BVX001 clinical candidate in a
model where tumours were established at a much larger size, making any
anti-cancer effects more significant. Here, we were able to report highly
statistically significant tumour regressions of 97% at day 28, with the vast
majority of the treated animals reported as either completely tumour free or
with non-measurable tumours at the end of dosing. Excitingly, BVX001
retained its potent anti-tumour activity in this challenging model system with
no observed adverse effects.
During the reporting period and consistent with our progress with BVX001, we
have dedicated significant operational and financial resources to enhance our
internal Research & Development ("R&D") capabilities, with the Company
investing £1.1 million in the first half of the year. Post period, we
successfully raised £2.1 million (gross) from the issue of 16,410, 887 new
ordinary shares at a price of 13p per share with the use of proceeds including
progressing BVX001 into clinical trials for AML.
In August 2023, we are happy to report that our first patent was issued in the
United States. Alongside this, we have subsequently received a Notice of
Allowance from the Japanese Patent Office, both of which relate to our initial
broad patent application safeguarding BVX001 at the antigen level. In addition
to Japan, this patent family is also currently being prosecuted in a further
six jurisdictions worldwide, providing robust protection for the asset.
Looking ahead, with the strong fundamentals BiVictriX has built, we plan to
expand our IP portfolio, while working on receiving an orphan drug designation
for BVX001. With a strong precedent in AML for granting accelerated /
conditional approval, we believe there is substantial opportunity for high
returns to generate shareholder value.
We continue to be endorsed by a range of prestigious industry awards for our
scientific acumen and strong management team. Of note, Tiffany Thorn has been
profiled by KPMG Acceleris
(https://www.kpmgbeyond.co.uk/videos/EntrepreneurSpotlightTiffanyThorn) for
International Women's Day, where they showcased the work and achievements
accomplished on BiVictriX's journey to revolutionise cancer therapies for the
most difficult-to-treat tumours. Tiffany was also named alongside some
inspirational individuals in the UK's Top 100 Influential People
(https://top100influentialpeople.com/the-winners-3/) , which highlighted
individuals who affect and impact society across a broad range of sectors as
chosen by a set of independent judges. Most recently, we were 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.
In summary, we have made strong and steady progress with our R&D pipeline
and expanding our IP estate. These accomplishments, coupled with the promising
in vivo safety and efficacy data on BVX001 and the development of our BVX002
and BVX003 programmes, have established a solid foundation for BiVictriX,
setting us up for significant future growth.
I would like to extend my gratitude to Tiffany Thorn, our CEO, for her
leadership and to the entire team for their diligent work over the past six
months, which has been instrumental in establishing BiVictriX as a prominent
biotech company. In addition, I'd like to thank Iain Ross, our founding
Non-Executive Chairman, along with the BiVictriX Board for their diligence in
helping the company advance. I also express my appreciation to our
shareholders for their continued support. I eagerly look forward to updating
the market on our progress in the year ahead.
Michael Kauffman, M.D., Ph.D.
Chairman of BiVictriX Therapeutics plc
Chief Executive Officer's Report
The year to date has been a period of remarkable development, as we have made
promising headway in advancing our lead programme, BVX001, towards the clinic.
I am pleased to once again be reporting on behalf of BiVictriX the positive
preclinical milestones we have hit in this short space of time, as well as the
progress made across other areas of the business. While we have focused on
building a strong preclinical package for BVX001 in support of its development
in humans, we have continued to initiate work in parallel on our discovery
programmes, BVX002 and BVX003, demonstrating the wider potential of the
platform across a broad array of different cancer types. We have strengthened
our intellectual property portfolio post period with two additional patents,
including a new platform-based patent application which applies across all
programmes. Importantly, post period, we successfully completed a capital
raise with new and existing shareholders, providing a further £2.1 million to
invest in the advancement of our therapeutic programmes. In the next six
months and beyond, I will continue to work closely with our executive team and
Board to achieve key value-enhancing milestones for the business.
Meaningful scientific progress
Over the past six months, we have continued to execute our development plan
for our lead therapeutic 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 delivered additional animal data to strengthen the
preclinical data package for this asset in Acute Myeloid Leukaemia ("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 Antibody Drug Conjugate ("ADC") indicated 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 murine toxicity model. Of note, one of the
known toxicities of Mylotarg™ that we evaluated in this study was a
reduction in normal neutrophil count, which heightens the risk of developing
significant and potentially fatal infections and sepsis - a major concern and
one of the leading causes of death in patients suffering from AML. We observed
no significant reduction in the number of healthy human neutrophils following
treatment with BVX001, compared to a reported >99% reduction in healthy
human neutrophils seen with Mylotarg™. These findings place us in a strong
position to break into the ADC market with the goal to offer a next-generation
cancer treatment with improved safety leading to more prolonged anti-AML
activity for patients. The preclinical profile thus far observed with BVX001
is consistent with markedly reducing this potentially fatal toxicity for
patients with AML.
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, we have not
observed any adverse effects, including weight loss, with our treatment. This
strong data from our first clinical candidate was supported by a second study,
in which the AML tumours were established at a much larger size relative to
the first study (~650mm(3) vs ~200mm(3)), 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. Full results, received after the period end, indicate that BVX001
retains its potent anti-tumour activity even in the 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 make up a strong preclinical data package which
demonstrates the significant potential of BVX001 as an effective treatment for
AML with a potentially higher therapeutic window as compared with GO and
standard chemotherapies, supporting plans to progress BVX001 into the clinic.
Further, it provides preclinical validation of our wider Bi-Cygni® platform
approach in improving cancer-specific targeting, reducing potentially harmful
or fatal side effects across a broad range of cancer indications.
Post period, we have continued to expand our broad patent portfolio with the
addition of new filings to provide further robust protection for BVX001 and
the wider platform. We also received notice, post period, that our United
States ("US") patent from the initial broad patent family, which provides wide
protection for BVX001 at the antigen fingerprint level, has been granted in
the US. The claims granted provide broad protection in the US 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.
Further to this, we have also received, post period, a Notice of Allowance
from the Japanese Patent Office with respect to our Japanese patent from this
patent family. It is anticipated that this patent will be granted in Japan in
the forthcoming weeks. In addition to the aforementioned, the Company is also
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.
Work also continues on our two additional discovery phase programmes, BVX002
and BVX003, which target solid tumours.
Board changes
Our Board of Directors and executive management team is comprised of highly
experienced individuals whose wealth of expertise has provided valuable
support over the past six months.
In January 2023, we announced the appointment of Dr Michael Kauffman, M.D.,
Ph.D. as Non-Executive Chairman of BiVictriX. Dr Kauffman took over the role
from Iain Ross, who stepped down from the role of Chairman due to other work
commitments and continues to support BiVictriX as a Non-Executive Director.
Since Michael's appointment to the Board of Directors in 2022, he has seen the
progress of BVX001 from an early-stage asset to a nominated clinical
candidate, and his appointment to Chairman came at a pivotal time in
BiVictriX's development as the asset moves closer to the clinic. He has
brought more than two decades of experience working across preclinical
research, clinical development, regulatory strategy and commercialisation,
having been instrumental in the global approvals of several oncology
therapeutics, and we welcome his insight and expertise in his new role.
Business development
BiVictriX has continued to foster key external relationships over the period,
with an aim of building and maintaining a network of connections with
academia, key opinion leaders, clinicians, regulators and potential industry
partners, laying the groundwork for future manufacturing, clinical and
commercialisation activities.
In the past six months, we have attended major international scientific and
investor conferences to continue building on this network and showcase our
next-generation precision ADC approach. By "precision ADC," we mean ADCs that
have a higher preclinical kill ratio for tumour cells over normal cells.
Notably, we attended the business development partnering conference Bio-Europe
Spring in March 2023, where we were able to secure over 20 meetings with key
large pharma organisations, together with big players in the ADC field. We
continue to mature relationships from this initial outreach and have
subsequently continued to receive a high level of interest in our assets and
overall platform approach from third parties. Aligned with the interest seen,
post period end and post capital raise, we have recently bolstered our
business development resources through engaging with an experienced, US-based,
business development consultant. This consultant is supporting the Company
through a broader outreach exercise which will be complemented by management
attendance at the upcoming international partnering conference, Bio-Europe, in
November 2023. These initiatives are part of our increased focus on business
development activities in the coming period targeting commercial partnerships.
We continue to present key data underpinning our unique approach at
internationally renowned scientific conferences. This included securing a key
presentation slot at the 20(th) annual PEGS Boston Conference and Exposition
in May 2023, where we were invited by the organisers to present our strong
preclinical data evaluating the safety and efficacy of BVX001 in AML. Post
period, we received an invitation to present at Wuxi's 2nd Global ADC and XDC
Innovation Conference in China in September 2023 and at PEGS Europe during
November 2023; both presentations will be delivered to an ADC-sector strong
audience. The presentation opportunities awarded to the Company are testament
to the incredibly positive and exciting data we have generated in the last
period and the interest received from a respected scientific audience to
showcase our novel therapeutic approach.
Financial performance
The Groups's loss after tax for the period was £1.2 million (H1 2022: £1.3
million). This reflected investment in R&D of £1.1 million (H1 2022:
£1.2 million) and administrative expenses of £0.3 million (H1 2022: £0.3
million).
The Group closed the period with a cash balance of £1.9 million at 30 June
2023 (H1 2022: £4.5 million) which has been further bolstered with the
receipt, post the period end, of an R&D tax credit payment of £0.5
million for the year ended 31 December 2022.
On 10 August the Company successfully completed a placing to raise £2.1
million gross with the issue of 16,410,917 new ordinary shares. This
investment will be used to support the further progression of BVX001 towards
the clinic through seeking Orphan Drug Designation status from the FDA,
together with delivering initial non-GLP toxicity data. Use of proceeds also
include progressing other proprietary programmes to generate initial
efficacy and safety data,demonstrating the broader applicability of the
platform across different cancer types.
We are delighted by the support received from both new and existing investors,
recent preclinical milestones in the Company's BVX001 programme acted as the
catalyst for this capital raise.
Summary and outlook
BiVictriX is at a formative and exciting time in its development, delivering
the next wave of precision cancer medicines, with the potential to vastly
improve outcomes for patients and their families across a broad spectrum of
cancer indications.
It has been a positive six months, and I am very encouraged by the growth we
have made towards future-proofing the Company, supported by notable progress
towards moving our lead asset, BVX001, towards the clinic and broadened
internal capabilities and know-how. Over the next period and beyond, I remain
fully committed to our business goals, including identifying opportunities to
accelerate Company growth through partnerships, and I look forward to
achieving key value-enhancing milestones, with a primary focus on the
acceleration of BVX001 into clinical trials for AML.
I would like to thank our existing and new shareholders, the whole team at
BiVictriX and the Board, to whom we are incredibly grateful for their
continued support and confidence in BiVictriX's future as a leader in
developing next-generation cancer therapies.
Tiffany Thorn,
Chief Executive Officer of BiVictriX Therapeutics plc
BiVictriX Therapeutics plc
INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2023
Statement of Comprehensive Income
6 Months Ended 6 Months Ended Year Ended
30 Jun 2023 30 Jun 2022 31 Dec 2022
£'000 £'000 £'000
Notes
Unaudited Unaudited Audited
Research and development (1,051) (1,209) (2,110)
General and administrative (293) (277) (738)
Share based compensation 4 (46) (64) (127)
Total operating expenses before non-recurring costs (1,390) (1,550) (2,975)
Operating loss (1,390) (1,550) (2,975)
Finance costs - - 4
Loss before tax (1,390) (1,550) (2,971)
Taxation 219 210 474
Loss for the period (1,171) (1,340) (2,497)
Basic loss per share (pence) 3 (1.77) (2.03) (3.78)
Diluted loss per share (pence) 3 (1.77) (2.03) (3.78)
BiVictriX Therapeutics plc
INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2023
Statement of Financial Position
30 June 2023 30 June 2022 31 Dec 2022
£'000 £'000 £'000
Unaudited Unaudited Audited
Assets
Non-current assets
Property, plant and equipment 655 510 571
Total non-current assets 655 510 571
Current assets
Trade and other receivables 224 291 224
Current tax receivable 674 402 454
Cash and cash equivalents 1,904 4,548 3,287
Total current assets 2,802 5,241 3,965
Total assets 3,457 5,751 4,536
Liabilities and equity
Current liabilities
Trade and other payables 214 454 284
Lease liabilities 195 246 107
Total current liabilities 409 700 391
Non-current Liabilities 216 - 188
Total Liabilities 625 700 579
Equity
Ordinary shares 661 661 661
Share premium 12,052 12,052 12,052
Share based compensation 397 288 351
Warrant reserve 73 73 73
Merger reserve (2,834) (2,834) (2,834)
Retained (deficit)/profit (7,517) (5,189) (6,346)
Total equity attributable to equity holders of the parent 2,832 5,051 3,957
Total liabilities and equity 3,457 5,751 4,536
BiVictriX Therapeutics plc
INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2023
Consolidated Statement of Changes in Equity
Ordinary shares Share Merger reserve Share based compensation Warrant reserve £'000s Retained deficit
£'000 Premium £'000 £'000 £'000 Total
£'000 £'000
Balance at 31 December 2021 661 12,052 (2,834) 224 73 (3,849) 6,327
Total comprehensive expense for the period - - - - - (1,340) (1,340)
Transactions with owners
Share option grant - - - 64 - - 64
Total transactions with owners - - - 64 - - 64
Balance at 30 June 2022 661 12,052 (2,834) 288 73 (5,189) 5,051
Total comprehensive expense for the period - - - - - (1,157) (1,157)
Transactions with owners -
Share based compensation - - - 63 - - 63
Total transactions with owners - - - 63 - - 63
Balance at 31 December 2022 661 12,052 (2,834) 351 73 (6,346) 3,957
Total comprehensive expense for the period - - - - - (1,171) (1,171)
Transactions with owners
Share based compensation - - - 47 - - 47
Lapsed share options - - - (1) - - (1)
Total transactions with owners - - - 46 - - 46
Balance at 30 June 2023 661 12,052 (2,834) 397 73 (7,517) 2,832
BiVictriX Therapeutics plc
INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2023
Statement of Cash Flows
Period ended 30 Jun 2023 £'000 Period ended 30 Jun 2022 £'000 Year ended 31 Dec 2022 £'000
Unaudited Unaudited Audited
Cash flows from operating activities
Loss before taxation (1,390) (1,550) (2,971)
Depreciation and amortisation 76 23 151
Share based compensation 46 64 127
Finance costs - - (4)
(1,268) (1,463) (2,697)
Changes in working capital
(Increase)/decrease in trade and other receivables - (4) 63
Increase/(decrease) in trade and other payables 45 146 25
Cash used in operations 45 (142) 88
Taxation received - - 212
Net cash used in operating activities (1,223) (1,321) (2,397)
Cash flows (used in)/generated from investing activities
Acquisition of tangible fixed assets (160) (194) (389)
Disposal of tangible fixed assets - - 10
Net cash (used in)/generated from investing activities (160) (194) (379)
Cash flows from financing activities
Proceeds from issue of shares - - -
Issue costs - - -
Repayment of lease liabilities - - -
Net cash generated from financing activities - - -
Movements in cash and cash equivalents in the period (1,383) (1,515) (2,776)
Cash and cash equivalents at start of period 3,287 6,063 6,063
Cash and cash equivalents at end of period 1,904 4,548 3,287
BiVictriX Therapeutics plc
Notes to the financial information
1. Company Information
BiVictriX Therapeutics plc (BiVictriX' or 'the Company') is a public limited
company incorporated in England and Wales. 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
in biotechnology.
2. Significant Accounting Policies and Basis of Preparation
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 operating under IFRS.
These interim financial statements do not include all the information required
for a complete set of financial statements prepared in accordance with IFRS
Standards. However, selected explanatory notes are included to explain events
and transactions that are significant to an understanding of the changes in
the Group's financial position and performance since the last annual
consolidated financial statements.
The financial information provided for the six-month period ended 30 June 2023
is unaudited, however, the same accounting policies, presentation and methods
of computation have been followed in these interim financial statements as
those which were applied in the preparation of the Group's annual consolidated
financial statements for the year ended 31 December 2022.
These unaudited interim financial statements were authorised for issue by the
Company's board of directors on 18th September 2023.
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.
The nature of the Group's operations mean that recorded financial performance
is not seasonal or cyclical in nature.
Going concern
In the normal course of business, the Directors regularly review rolling cash
flow forecasts.
These operational cashflow forecasts include 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. The review of financial forecasts and
cash flows for a period of at least 12 months from the approval of these
interim financial statements includes levers and controls which could be
applied, if necessary.
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, they continue
to adopt the going concern basis in preparing these financial statements.
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 results of the
Group.
Research and development expenditure
Development costs and expenditure on pure and applied research are charged to
the profit and loss account in the year in which they are incurred.
Expenditure incurred on the development of internally generated products will
be capitalised from when Phase III trials are completed, and regulatory
approval is obtained.
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.
Share based payment charge
In the period, share options were issued to certain employees and a
Black-Scholes model was used to calculate the share-based payment charge.
The calculation involves estimates and judgements to establish the appropriate
inputs to be entered into the model, including interest rate, dividend rate,
exercise restrictions and behavioural considerations.
The total charge in the period was £46k (H1 2022: £64k).
3. Loss per Share
Basic loss per share is calculated by dividing the loss for the period
attributable to equity holders by the weighted average number of ordinary
shares outstanding during the year.
For diluted loss per share, the loss for the period attributable to equity
holders and the weighted average number of ordinary shares outstanding during
the period is adjusted to assume conversion of all dilutive potential ordinary
shares.
At 30 June 2023, the Group had 8,804,184 (30 June 2022: 8,644,184) share
options, warrants and subscriptions outstanding.
The calculation of the Group's basic and diluted loss per share is based on
the following data:
Period ended Period ended Year ended
30 Jun 30 Jun 31 Dec
2023 2022 2022
£'000 £'000 £'000
Loss for the period attributable to equity holders for basic loss and adjusted (1,390) (1,340) (2,497)
for the effects of dilution
Period ended Period ended Year ended
30 Jun 30 Jun 31 Dec
2023 2022 2022
Weighted average number of ordinary shares for basic loss per share 66,115,171 66,115,171 66,115,171
Effects of dilution:
Share options - - -
Weighted average number of ordinary shares adjusted for the effects of 66,115,171 66,115,171 66,115,171
dilution
Period ended Period ended Year ended
30 Jun 30 Jun 31 Dec
2023 2022 2022
£ £ £
Loss per share - basic and diluted (1.77) (2.03) (3.78)
The loss and the weighted average number of ordinary shares for the period
ended 30 June 2023 and 30 June 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.
4. Share-based Payments
Certain Directors and employees of the Group hold options to subscribe for
shares in the Group under 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.
The Group operates one share option scheme, in addition share options have
been granted under standalone unapproved share option agreements. Options are
currently granted for £nil consideration and are exercisable at a price
determined on the date of the grant.
At 30 June 2023 the Company had 8,804,184 (30 June 2022: 8,634,184) unissued
ordinary shares of 1p under the Company's share option schemes, details of
which are as follows:
Movements on share options during the period were as follows:
Exercise price At 31 Dec 2022 Granted Lapsed At 30 Jun Date from which exercisable Expiry date
2023
0.117 365,295 - - 365,295 11 Aug 2021 8 Apr 2031
0.200 3,290,875 - - 3,290,875 11 Aug 2021 8 Apr 2031
0.200 1,632,680 - - 1,632,680 11 Aug 2023 8 Apr 2031
0.200 2,449,000 - - 2,449,000 11 Aug 2024 8 Apr 2031
0.250 876,334 - 30,000 846,334 13 Dec 2024 13 Dec 2031
0.250 30,000 - - 30,000 3 May 2025 2 May 2032
0.205 40,000 - - 40,000 14 Sep 2025 13 Sep 2032
0.170 50,000 - - 50,000 22 Dec 2025 21 Dec 2032
0.150 - 100,000 - 100,000 10 May 2026 9 May 2033
8,734,184 100,000 30,000 8,804,184
5. Post balance sheet events
On 10 August 2023 the Company issued 16,410,887 new ordinary shares at a price
of 13 pence which raised gross proceeds of £2,133,415.
6. Copies of the interim report
Copies of the interim report are available on the Company's website at
www.bivictrix.com (http://www.bivictrix.com)
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