REG - BiVictriX Therapcts. - Interim Results
01/08/2024 07:00
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RNS Number : 6863Y BiVictriX Therapeutics PLC 01 August 2024
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BIVICTRIX THERAPEUTICS PLC
("BiVictriX" or "the Company" or "the Group")
Interim Results for the Six Months Ended 30 June 2024
Alderley Park, 1 August 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 reducing treatment-related toxicities, today
announces its unaudited interim results for the six months ended 30 June 2024.
Highlights, including post period:
· Safety data supports progression of BVX001 into the clinic. Data
compares favourably to approved ADCs with same linker and cytotoxic payload
and informs clinical dose selection ahead of final IND-enabling studies
· BVX001 granted Orphan Drug Designation by the FDA for the treatment
of AML, providing commercial and regulatory benefits
· Positive INTERACT meeting with the FDA for BVX001, providing
efficient route forward for IND submission
· Innovate UK grant provides non-dilutive capital to accelerate BVX002,
our second drug candidate which targets solid tumours
· Continued progression and expansion of target discovery platform with
Bi-Cygni® target pairs discovered in over ten different cancer types,
including lung, breast and bladder cancer
· Cash and cash equivalents of £1.7 million as at 30 June 2024 (£1.9
million at 30 June 2023)
Tiffany Thorn, Chief Executive Officer of BiVictriX Therapeutics plc,
commented: "In the first half of the year, BiVictriX has continued to execute
on its strategy of discovering and developing novel, potentially
best-in-class bispecific ADCs targeting multiple cancer types. Our lead
product, BVX001, has now shown positive preclinical safety and efficacy data
in multiple in vivo models, highlighting its potential for improved efficacy
and superior cancer selectivity compared with existing AML agents. I am
pleased with our initial interaction with the FDA, as we look to progress
BVX001 into the clinic. Furthermore, we have made significant progress in the
solid tumour space through the identification of a lead for our solid tumour
programme, BVX002, together with the expansion of our target discovery library
to include some of the largest commercial cancer types, including lung and
breast cancers."
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, Caroline Rowe (Corporate Finance)
Vadim Alexandre, Rob Rees (Sales and Broking) Tel: +44 (0) 20 3470 0470
Panmure Liberum (UK) Limited (Joint Broker)
Emma Earl, Freddy Crossley, Rupert Dearden
Tel: +44 (0) 20 7886 2500
ICR Consilium
Namrata Taak, Lucy Feathersone, 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 am pleased to report on our encouraging progress in the first half of 2024,
as we continue our path to becoming a clinical stage biotech company with a
novel and differentiated therapeutic pipeline of bispecific Antibody Drug
Conjugates ("ADCs") with enhanced selectivity for tumour over normal cells.
The BiVictriX team continues to expand our potential with a growing portfolio
of proprietary bispecific ADCs targeting both solid and liquid tumours. Our
unique approach with our proprietary Bi-Cygni® platform enables us to target
novel cancer-specific twin antigen fingerprints, with bespoke tuneable, ADC
therapeutics.
Our lead programme and primary focus, BVX001, targets Acute Myeloid Leukaemia
("AML"), the most aggressive form of adult leukaemia, a disease with dismal
clinical outcomes and poor survival rates.
During the period, we reported further positive preclinical safety and
efficacy results in established in vivo models and using AML cells directly
from patients. Our data package strongly supports the progression of BVX001
into the clinic, and we believe we have an emerging profile that could be
best-in-class targeting neoplastic cells whilst sparing normal myeloid cells,
including disease-fighting neutrophils. This has been further supported by
initial positive interactions with the FDA and with the recent grant of Orphan
Drug Designation for BVX001.
Consistent with our identification of BVX002 for the treatment of ovarian
cancer, our wider platform has the ability to address over ten different
cancer types. We have recently expanded our proprietary twin-antigen target
library to include novel, cancer-specific target pairs across a number of
commercially meaningful indications, including lung, breast and bladder
cancer, areas of significant and growing commercial interest.
During the reporting period and aligned with our focus, we have prioritised
our Research & Development ("R&D") capabilities, with the Company
investing £1.2 million in the first half of the year.
Outlook
Looking ahead, with the strong fundamentals BiVictriX has built, we plan to
expand our Intellectual Property portfolio and target discovery activities to
build a robust library of commercially attractive novel therapeutic leads,
while continuing to progress BVX001 and BVX002 towards the clinic.
The Directors believe BiVictriX has one of the leading platforms in the
bispecific ADC space and needs to be able to maintain competitiveness in a
rapidly expanding landscape by moving BVX001 as expeditiously as possible into
the clinic and demonstrating anti-leukemic activity and tolerability, as well
as to progress our other programmes at a competitive rate.
With recent precedents in AML for granting accelerated / conditional approval,
we believe there is a substantial opportunity to generate additional
shareholder value. As such, the Directors will continue to assess the various
commercial and strategic business development opportunities available to them
with regards to both the future funding and growth of the Company.
Conclusions
In summary, we have made encouraging progress with our R&D pipeline. These
accomplishments, coupled with the promising in vivo safety and efficacy data
on BVX001 and the development of our lead drug candidate in our solid tumour
programme, BVX002, have established a solid foundation for BiVictriX, setting
us up to take advantage of future opportunities.
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 the BiVictriX Board for their
diligence in helping the Company advance. I also express my appreciation to
our shareholders for their continued support, and I eagerly look forward to
updating the shareholders 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 significant progress towards advancing
our lead assets towards the clinic and establishing BiVictriX as a global
leader in the bispecific ADC space. We have once again met our challenging
R&D milestones and delivered highly compelling data across our lead AML
and solid tumour assets whilst prudently managing our capital. We have placed
an increased and significant emphasis on our corporate activities during the
period, to take advantage of the continuing global commercial interest in
novel ADC approaches by large pharma and other biotech companies, as
our technology gains greater visibility and appreciation.
Our R&D activities have centred upon the progression of BVX001 towards
clinical readiness, accelerating our path to the clinic for BVX002, and
scaling our drug discovery platform to address a wider range of solid tumours.
We continue to strengthen and maintain our Intellectual Property portfolio and
are very encouraged by our initial positive interactions with the FDA and
leading Key Opinion Leaders ("KOLs") in the AML space, highlighting a clear
path forward for BVX001. I continue to work closely with our executive team,
internal R&D teams and Board to achieve key value-enhancing milestones for
our business, with a key focus on value creation for our shareholders.
Meaningful scientific progress
Over the past six months, we have continued to execute on our development plan
for our lead therapeutic asset, BVX001. We have met several key preclinical
milestones which are essential for progressing this molecule towards the
clinic.
Since nominating our clinical candidate in June 2023, based on a positive in
vivo efficacy profile in murine models of disease, we have been able to
further demonstrate the potential efficacy of this therapeutic across a panel
of primary samples from patients with AML. The preclinical profile thus far
observed with BVX001 is consistent with the potential to result in deeper and
more durable regressions with markedly reduced activity against normal
infection-fighting white blood cells, thereby offering the possibility of
reducing potentially fatal toxicity for patients with AML and related
diseases.
Further to this, in June of this year, we reported data for BVX001 showing an
in vivo safety profile in an established rodent model of toxicity supporting
progression to final IND-enabling studies and towards clinical studies. This
repeat dose finding preclinical study assessed the tolerability, toxicity and
toxicokinetics of BVX001 at 10, 30 and 55mg/kg given intravenously, and
studied the effects on standard behavioural and clinical endpoints (including
haematology and serum chemistry) and macro/microscopic changes in a number of
organs and tissues. BVX001 was tolerated across the dose-range with adverse
clinical and anatomic pathology changes primarily observed only at the high
dose level, far in excess of doses required for anti-leukaemic activity as
discussed below. Ocular toxicity was not observed at mid to low doses, and
affects at higher doses were graded as minimal with no severe pathological
changes seen at all doses tested.
Importantly, if converted to human equivalent doses, the doses tested here
were up to 11-times higher than equivalent doses used in a mouse xenograft
study that showed significant tumour regressions (up to 97% versus control) in
a hard-to-treat AML tumour model, as we reported in 2023. These data provide
us with further confidence in the tolerability of this drug candidate at doses
that confer marked anti-leukemic activity in the preclinical models. Together,
they highlight the clear benefits of the Bi-Cygni® platform versus the de
facto (single antigen) ADC approach, where the safety window for killing
tumour versus normal cells reported is typically minimal.
We are greatly encouraged by these data as they round out our comprehensive
preclinical package. These data will be submitted for formal presentation at
forthcoming medical meetings, as part of our strategy to showcase our data to
a wider audience.
In total, our preclinical studies demonstrate the significant potential of
BVX001 as an effective treatment for AML with a potentially higher therapeutic
window as compared to existing therapeutic options and support our plans to
progress BVX001 into the clinic. In addition, progress with our lead
bispecific ADC validates the wider Bi-Cygni® platform approach to offer the
ability for improved cancer cell-specific targeting leading to the potential
for reduced serious side effects across a broad range of cancer indications.
Expanding and accelerating our BiVictriX Solid Tumour pipeline
Solid tumours represent the largest commercial opportunity for ADC
therapeutics, which aligns to BiVictriX's increased activities in this space
during 2023 to 2024. Our lead solid tumour asset, BVX002, is progressing well,
and we were delighted to receive an Innovate Grant from the UK Government in
recognition of the drug's potential in the ovarian cancer setting. This grant
of c. £0.4 million enables us to perform key preclinical work as we progress
our plans towards filing an IND for BVX002.
Additionally, we have expanded our Bi-Cygni® target pair library with the
identification of novel and proprietary, cancer-specific antigen pairs across
ten different cancer types, including breast and lung cancers which represent
some of the largest commercial opportunities. Our plans are to develop our
solid tumour pipeline to provide the Company with future partnership
opportunities.
Positive initial FDA interactions
During the first half of 2024, we concluded our first successful interactions
with the FDA, the key regulatory body in the United States, where we recently
received confirmation of grant of Orphan Drug Designation status for BVX001,
providing significant potential patent exclusivity and regulatory benefits to
BiVictriX as we progress the candidate towards clinical studies. Further to
this, we have also received positive feedback from the FDA via the INTERACT
meeting, providing initial support for our plans for an efficient path to IND
for BVX001. We now head towards our IND filing for BVX001 with increasing
confidence.
Business development
We have continued to build key external relationships over the period, with an
aim of establishing and maintaining a network of connections with academia,
KOLs, other clinicians, regulators and industry partners. There has been much
activity across all these fronts in 2024 to date, as we benefit from the
increasing acceptance of ADCs as a key component of cancer therapy in the
future. Ongoing and further work with these key partners will provide multiple
opportunities for future manufacturing, clinical and commercialisation
alliances to optimise the value potential of our entire business.
We have attended major international scientific and investor conferences to
continue building on this network and to highlight our next-generation
precision ADC approach. Notably, we attended the European Hematology
Association (EHA) meeting in May 2024, securing meetings with many global
leaders in the AML space. These relationships are key to optimise our clinical
trial design and ensure we are working with leading physicians to bring our
product to patients.
Financial performance
The Groups's loss after tax for the period was £1.3 million (H1 2023: £1.2
million), reflecting investment in R&D of £1.2 million (H1 2023: £1.1
million) and administrative expenses of £0.4 million (H1 2023: £0.3
million).
The Group closed the period with a cash balance of £1.7 million at 30 June
2024 (30 June 2023: £1.9 million). Excluding the manufacturing and clinical
trial costs for BVX001, the Company currently has sufficient capital to funds
its working capital requirements into Q2 2025.
Summary and outlook
BiVictriX is at a key juncture having achieved much success from our novel
technology with prudent capital utilisation. We are proud of our progress in
bringing our lead asset all the way from concept to "IND ready", at a fraction
of the cost of our peers, prioritising R&D expenditure towards key data
that will drive value in BiVictriX. As we move towards obtaining clinical data
across our portfolio, we believe we are well placed to scale our activities to
broaden our pipeline further. The increasing breadth of BiVictriX and the
ongoing interest in ADCs as a therapeutic class provides a significant
tailwind for our business.
I am encouraged by the continued progress made in the period, showcasing the
advantages of our novel therapeutic approach and believe that the progression
of our lead asset to reach early clinical efficacy data will help to ensure
the Company is well placed to feature on the global ADC stage, as a future
driver of this technology. Over the next period and beyond, I remain fully
committed to our key business goals, including identifying opportunities to
accelerate the Company's growth through partnerships and alliances, and I look
forward to achieving the next key value-enhancing milestones, with a primary
focus on the acceleration of BVX001 into clinical trials in AML and related
conditions, as well as expansion into the solid tumour space initially with
BVX002.
I would like to thank the entire BiVictriX team and Board for their hard work
in 2024 to date and express my gratitude to all of our existing shareholders
for their continued support, belief and confidence in BiVictriX's future as a
global leader delivering next generation, highly targeted cancer therapeutics.
Tiffany Thorn,
Chief Executive Officer and Founder of BiVictriX Therapeutics plc
BiVictriX Therapeutics plc
INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2024
Statement of Comprehensive Income
6 Months Ended 6 Months Ended Year Ended
30 Jun 2024 30 Jun 2023 31 Dec 2023
£'000 £'000 £'000
Notes
Unaudited Unaudited Audited
Other income 3 66 - -
Research and development (1,186) (1,051) (2,047)
General and administrative (424) (293) (904)
Share based compensation 5 (65) (46) (74)
Total operating expenses (1,675) (1,390) (3,025)
Operating loss (1,609) (1,390) (3,025)
Finance income 16 - 22
Loss on ordinary activities before taxation (1,593) (1,390) (3,003)
Taxation 296 219 458
Loss for the period (1,297) (1,171) (2,545)
Basic loss per share (pence) 4 (1.79) (1.77) (3.50)
Diluted loss per share (pence) 4 (1.79) (1.77) (3.50)
BiVictriX Therapeutics plc
INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2024
Statement of Financial Position
30 June 2024 30 June 2023 31 Dec 2023
£'000 £'000 £'000
Unaudited Unaudited Audited
Assets
Non-current assets
Property, plant and equipment 390 655 476
Total non-current assets 390 655 476
Current assets
Trade and other receivables 210 224 144
Current tax receivable 692 674 396
Cash and cash equivalents 1,689 1,904 3,279
Total current assets 2,591 2,802 3,819
Total assets 2,981 3,457 4,295
Liabilities and equity
Current liabilities
Trade and other payables 473 214 496
Lease liabilities 116 195 128
Total current liabilities 589 409 624
Non-current Liabilities 87 216 134
Total Liabilities 676 625 758
Equity
Ordinary shares 825 661 825
Share premium 13,939 12,052 13,939
Share based compensation 397 397 425
Warrant reserve 73 73 73
Merger reserve (2,834) (2,834) (2,834)
Retained (deficit)/profit (10,095) (7,517) (8,891)
Total equity attributable to equity holders of the parent 2,305 2,832 3,537
Total liabilities and equity 2,981 3,457 4,295
BiVictriX Therapeutics plc
INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2024
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 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 option grant - - - 46 - - 46
Total transactions with owners - - - 46 - - 46
Balance at 30 June 2023 661 12,052 (2,834) 397 73 (7,517) 2,832
Total comprehensive expense for the period - - - - - (1,374) (1,374)
Transactions with owners
Share issue - cash 164 1,969 - - - - 2,133
Expense of share issue - (82) - - - - (82)
Share based compensation - - - 28 - - 28
Total transactions with owners - - - 28 - - 28
Balance at 31 December 2023 825 13,939 (2,834) 425 73 (8,891) 3,537
Total comprehensive expense for the period - - - - - (1,204) (1,204)
Transactions with owners
Share based compensation - - - 65 - - 65
Share based compensation - lapsed options - - - (93) - - (93)
Total transactions with owners - - - (28) - - (28)
Balance at 30 June 2024 825 13,939 (2,834) 397 73 (10,095) 2,305
BiVictriX Therapeutics plc
INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2024
Statement of Cash Flows
Period ended 30 Jun 2024 £'000 Period ended 30 Jun 2023 £'000 Year ended 31 Dec 2023 £'000
Unaudited Unaudited Audited
Cash flows from operating activities
Loss before taxation (1,593) (1,390) (3,003)
Depreciation and amortisation 90 76 165
Share based compensation 65 46 74
Finance costs (9) - (8)
(1,447) (1,268) (2,769)
Changes in working capital
(Increase)/decrease in trade and other receivables (66) - 80
Increase/(decrease) in trade and other payables (23) 45 213
Cash used in operations (89) 45 293
Taxation received - - 516
Net cash used in operating activities (1,536) (1,223) (1,960)
Cash flows (used in)/generated from investing activities
Acquisition of tangible fixed assets (4) (160) (5)
Interest received 16 - 22
Net cash (used in)/generated from investing activities 12 (160) 17
Cash flows from financing activities
Proceeds from issue of shares - - 2,133
Issue costs - - (82)
Repayment of lease liabilities (66) - (116)
Net cash generated from financing activities (66) - 1,935
Movements in cash and cash equivalents in the period (1,590) (1,383) (8)
Cash and cash equivalents at start of period 3,279 3,287 3,287
Cash and cash equivalents at end of period 1,689 1,904 3,279
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
of pharmaceutical products.
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 2024
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 2023.
These unaudited interim financial statements were authorised for issue by the
Company's Board of Directors on 31 July 2024.
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. The review of financial forecasts and cash flows looking at
least 12 months from 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, they continue
to adopt the going concern basis in preparing these unaudited financial
statements.
At 30 June 2024, the Group had cash and cash equivalents of £1.7 million (30
June 2023: £1.9 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 of disclosure of the Group.
Government grants
UK government grants are for named projects and provide reimbursement of
specific costs incurred on these projects. The grants are paid after each
reporting period when the claim is submitted. The administering body has the
right to request information on any items included in each grant claim and to
request an Independent Auditor's report.
There are no clawback provisions relating to the grants as they are not paid
until after the relevant expenditure has been incurred and agreed, and this is
the only condition.
Revenue-based grants have been credited to the statement of comprehensive
income in the period to which they relate and reported as other income.
Research and development expenditure
Expenditure on pure and applied research are charged to the profit and loss
account in the year in which it is incurred. Development costs are charged to
the 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 expensed to the income
statement.
Share-based compensation
The Group has issued share options to certain employees and Directors.
Warrants have been issued to certain external third parties. Such
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.
Share based payment charges
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 £65,392 (H1 2023: £46,239).
3. Other Income
Other operating income of £66,107 (H1 2023: Nil) was derived from the first
quarter of a £0.4 million Innovate UK grant, which was awarded on 4 June
2024.
4. 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 2024, the Group had 10,533,616 (30 June 2023: 8,804,184) 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
2024 2023 2023
£'000 £'000 £'000
Loss for the period attributable to equity holders for basic loss and adjusted (1,297) (1,390) (2,545)
for the effects of dilution
Period ended Period ended Year ended
30 Jun 30 Jun 31 Dec
2024 2023 2023
Weighted average number of ordinary shares for basic loss per share 72,645,075 66,115,171 72,645,075
Effects of dilution:
Share options - - -
Weighted average number of ordinary shares adjusted for the effects of 72,645,075 66,115,171 72,645,075
dilution
Period ended Period ended Year ended
30 Jun 30 Jun 31 Dec
2024 2023 2023
£ £ £
Loss per share - basic and diluted (1.79) (1.77) (3.50)
The loss and the weighted average number of ordinary shares for the period
ended 30 June 2024 and 30 June 2023 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.
5. Share option grants
The Group operates an Enterprise Incentive (EMI) share option plan and an
Employee Related Share (ERS) scheme for employees, together with a
non-employee share option plan. Options are granted for nil consideration and
are exercisable at a price which is determined on the date of the grant.
Directors and employees hold options to subscribe for shares in BiVictrix
Therapeutics plc in accordance with the rules of the Group share option plans.
The maximum number of Ordinary shares which may be issued under the Group's
share option plans is 12,245,050. At 30 June 2024, this share option pool
represented 14.8 per cent of the issued share capital in BiVictrix
Therapeutics plc.
In addition to the Company share option pool of 12,245,050 share options,
Tiffany Thorn holds 2,023,500 share options arising from pre-existing share
options which were exchanged at Admission in August 2021, for new options over
ordinary shares in BiVictriX Therapeutics plc.
At 30 June 2024, the Company had 9,283,334 share options under grant. 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:
Exercise price At 31 Dec Granted Lapsed At 30 Jun Date from which exercisable Expiry date
2023 2024
0.117 365,295 - - 365,295 11 Aug 2021 3 Aug 2031
0.200 3,290,875 - (408,170) 2,882,705 11 Aug 2021 3 Aug 2031
0.200 2,449,000 - - 2,449,000 09 Feb 2022 3 Aug 2031
0.200 1,632,680 - (1,632,680) - 11 Aug 2021 3 Aug 2031
0.250 846,334 - 846,334 06 Jun 2023 12 Dec 2032
0.205 40,000 - (40,000) - 14 Sep 2023 13 Sep 2032
0.170 50,000 - - 50,000 22 Dec 2023 21 Dec 2032
0.150 70,000 (30,000) 40,000 10 May 2024 9 May 2033
0.1175 - 2,650,000 - 2,650,000 27 Mar 2025 26 Mar 2034
8,744,184 9,283,334
Of the 9,283,334 options in issue at 30 June 2024, 8,483,334 were issued to
employees including 4,036,334 options granted under the EMI scheme and
4,447,000 granted under the ERS. Option grants under the non-employee share
option plan were 800,000.
The total charge in the period relating to share based compensation was
£65,392 (H1 2023: £46,239).
6. Post balance sheet events
There were no post balance sheet events to report.
7. 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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