TIDMBVX
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(TM). 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(R) platform to provide
BiVictriX with diverse opportunities to pursue commercial
partnerships.
-- Cash and cash equivalents of GBP1.9 million at 30 June 2023 ,
bolstered post period end by an R&D tax credit payment of
GBP0.5 million.
-- Successful placing which raised gross proceeds of GBP2.1
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(R) 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 GBP2.1 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 Email: info@bivictrix.com
Officer
Michael Kauffman, Non-Executive
Chairman
SP Angel Corporate Finance LLP
(NOMAD and Broker) Tel: +44 (0) 20 3470 0470
David Hignell, 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 Email: 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(R) 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 and connect with us on
LinkedIn and Twitter @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(R) 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(R)
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(TM), 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
GBP1.1 million in the first half of the year. Post period, we
successfully raised GBP2.1 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 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 , 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 , 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 GBP2.1 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(TM), 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(TM) in a murine toxicity model.
Of note, one of the known toxicities of Mylotarg(TM) 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(TM).
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(R) 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 GBP1.2 million
(H1 2022: GBP1.3 million). This reflected investment in R&D of
GBP1.1 million (H1 2022: GBP1.2 million) and administrative
expenses of GBP0.3 million (H1 2022: GBP0.3 million).
The Group closed the period with a cash balance of GBP1.9
million at 30 June 2023 (H1 2022: GBP4.5 million) which has been
further bolstered with the receipt, post the period end, of an
R&D tax credit payment of GBP0.5 million for the year ended 31
December 2022.
On 10 August the Company successfully completed a placing to
raise GBP2.1 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 MONTHSED 30 JUNE 2023
Statement of Comprehensive Income
6 Months 6 Months Year Ended
Ended Ended 31 Dec
30 Jun 30 Jun 2022
Notes 2023 2022 GBP'000
GBP'000 GBP'000
--------------------------------- -------- ---------- ---------- -----------
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 MONTHSED 30 JUNE 2023
Statement of Financial Position
30 June 30 June 31 Dec
2023 2022 2022
GBP'000 GBP'000 GBP'000
-------------------------------- ---------- ---------- ---------
Unaudited Unaudited Audited
A ssets
N o n-cu rrent assets
P r o p e r t y , pl a nt a nd
eq u ip m e nt 655 510 571
T ot a l non-cu rrent assets 655 510 571
C u rren t assets
T rad e a nd o the r r ec e i
v ab les 224 291 224
C u r r e n t tax r ec e i v
ab le 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 MONTHSED 30 JUNE 2023
Consolidated Statement of Changes in Equity
Ordinary Share Merger Share based Warrant Retained
shares Premium reserve compensation reserve deficit Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000s GBP'000 GBP'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 MONTHSED 30 JUNE 2023
Statement of Cash Flows
Period Period Y ear ended
ended 30 ended 30 31 Dec
Jun 2023 Jun 2022 2022 GBP'000
GBP ' 000 GBP ' 000
Unaudited Unaudited Audited
Cas h fl o ws fr om ope r a ting
a c t i v i ties
L o s s b e f o re ta x ati on (1,390) (1,550) (2,971)
D ep r eci ati o n a nd a m o r t
i s a t i on 76 23 151
Sh a r e b as ed c o m p en s a t
i o n 46 64 127
Finance costs - - (4)
------------------------------------- ---------- ---------- -------------
(1,268) (1,463) (2,697)
Chang es i n w or k ing capit al
( I nc r e as e ) / dec r e as e i
n t rade a nd o ther r ec e i v ab
les - (4) 63
I nc r e as e / ( dec r e as e ) i
n t rade a nd o ther p a y ab les 45 146 25
---------- ---------- -------------
Cash used in operations 45 (142) 88
Taxation received - - 212
Net cas h used i n ope r a t ing
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)
Cas h fl o ws fr om fina ncing a
c t i v i ties
Proceeds from issue of shares - - -
Is s u e c os ts - - -
Repayment of lease liabilities - - -
------------------------------------- ---------- ---------- -------------
N et cash g e n e r a ted fr om fina - - -
ncing a c t i v i ties
------------------------------------- ---------- ---------- -------------
M o v e m en ts in cash a nd cash
eq u i v a lents in t he pe ri od (1,383) (1,515) (2,776)
------------------------------------- ---------- ---------- -------------
Cash a nd c ash eq u i vale n t s
at s t a rt of p e r i od 3,287 6,063 6,063
------------------------------------- ---------- ---------- -------------
Cas h a n d cash eq u i v a lents
at end of pe ri od 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. Sign ific a nt Acc ou nti ng P ol ici es a nd B a sis of P r
e p ar a ti on
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 (GBP) and
rounded to the nearest GBP000. 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.
G oi n g c o nce rn
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.
R es ea r ch and d e v e lop m e nt e xpe nd i t u re
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.
Sh ar e - based c om pe n sa ti o n
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.
Sh ar e b a sed p a y m e nt ch ar ge
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 GBP46k (H1 2022: GBP64k).
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.
T h e c a lc u l at ion o f the G r ou p 's b a s ic a nd d il u
t ed loss p er s h a re is b a s ed on the f o l l o w i ng d a t
a:
Period e nded Period ended Y ear en ded
3 0 Jun 30 Jun 3 1 Dec
2023 2022 20 22
GBP ' 000 GBP'000 GBP ' 000
----------------------------------- ------------- ------------ ------------
Loss for the period attributable
to equity holders for basic
loss and adjusted for the effects
of dilution (1,390) (1,340) (2,497)
----------------------------------- ------------- ------------ ------------
Period e nded Period ended Y ear en
3 0 Jun 30 Jun ded
2023 2022 3 1 Dec
20 22
------------------------------ ------------- ------------ ----------
W e ig h t ed a v e r a ge
num ber of o rd ina ry s ha
res for b asic loss per s ha
re 66,115,171 66,115,171 66,115,171
------------------------------ ------------- ------------ ----------
E ff e c ts of d il u t i o
n: - - -
Sh a r e o p ti o n s
------------------------------ ------------- ------------ ----------
W e ig h t ed a v e r a ge
num ber of o rd ina ry s ha
res adju s ted for t he ef
fects of dilu tion 66,115,171 66,115,171 66,115,171
------------------------------ ------------- ------------ ----------
Period e nded Period ended Y ear en
3 0 Jun 30 Jun ded
2023 2022 3 1 Dec
GBP GBP 20 22
GBP
------------------------------- ------------- ------------ --------
L o s s p er s h a re - b asic
a nd d il u t ed (1.77) (2.03) (3.78)
------------------------------- ------------- ------------ --------
T h e los s a nd the w e ig h t ed av era ge n um b er of o r d
i n a ry s h a r es f or the period en ded 30 June 2 0 23 a nd 30
June 2022 u s ed f or c a lc u l ati ng t he d il u t ed loss p er
s h a re a re i d e n t i c al to t ho se f or the b a s ic loss p
er s h a r e. T his is b e c a u se the outs t a nd i ng s h a re o
pt io ns w o u ld h ave t he eff e ct of r e duc i ng the loss p er
o r d i n a ry s h a re a nd w o u ld th e r e f o re n ot be d il
u t i ve u n d er the t e r ms of I n t e r n at ion al Acc o u n
ti ng S t a n d a rd ( ' IA S ') No 3 3.
4. Sh ar e-b a sed P a y m e nts
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 GBPnil 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:
M ov eme n t s on s h a re o pt io ns d u r i ng the period w e
re as f o l l o w s:
E x e A t 31 Dec Gra n L aps ed At 3 0 Da te f E xp i ry
r cis 20 22 ted Jun r om wh ich da te
e price 2023 ex e r cisable
-------- -------------- ------- ------------- --------- --------------- -----------
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
GBP2,133,415.
6. Copies of the interim report
Copies of the interim report are available on the Company's
website at www.bivictrix.com
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END
IR EVLFFXKLLBBQ
(END) Dow Jones Newswires
September 19, 2023 02:00 ET (06:00 GMT)
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