TIDMAVCT
RNS Number : 4469N
Avacta Group PLC
30 September 2021
30 September 2021
Avacta Group plc
("Avacta", the "Company" or the "Group")
Interim Results for the Period Ended 30 June 2021 and Business
Update
Transformative period for both Diagnostics and Therapeutics
Divisions
Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical
company developing innovative cancer therapies and powerful
diagnostics based on its proprietary Affimer(R) and pre|CISION(TM)
platforms, announces its interim results for the period ended
30(th) June 2021 and business update.
Operating Highlights
Avacta Diagnostics
Transformation of Diagnostics Division to become an ISO 13485
accredited in-vitro diagnostic (IVD) products business, and first
sales (post-period) of its high performance AffiDX (R) SARS-CoV-2
antigen lateral flow test. Global profile of Avacta and the
Affimer(R) diagnostic reagents platform substantially increased
over the period.
-- Clinical validation study of Avacta's AffiDX(R) SARS-CoV-2
antigen lateral flow test carried out on 98 positive COVID-19
samples (31 with Ct<26; 65 with Ct 26-30 and 2 with Ct 30-31)
and 102 negative samples demonstrates clinical sensitivity of 98.0%
and clinical specificity of 99.0%. Additional data obtained
post-period end from a further 134 negative samples has further
defined the clinical specificity to be 99.6%.
-- AffiDX(R) SARS-CoV-2 antigen lateral flow test shown to
detect the Delta variant of the SARS-CoV-2 virus in clinical
samples and to outperform two lateral flow antigen tests that are
widely commercially available in Europe. The test has also been
shown to detect the Alpha, Beta and Gamma variants in an earlier
study.
-- Declaration of conformity for CE mark for professional use of
AffiDX(R) SARS-CoV-2 antigen lateral flow test submitted to
Medicines and Healthcare products Regulatory Agency (MHRA).
-- Product registration received, in both the UK and EU, for the
professional use AffiDX(R) SARS-CoV-2 antigen lateral flow
test.
-- Multiple collaborations and commercial partnerships entered
into during the period and post-period end:
o Royalty bearing license agreement with Biokit, a Werfen
Company, to develop and commercialise an undisclosed Affimer (R)
-based in-vitro diagnostic test.
o Collaboration agreement with Bruker Corporation to evaluate
the clinical utility and commercial potential of a mass
spectrometry-based SARS-CoV-2 antigen test developed with Adeptrix
Inc.
o Global distribution agreement with ABCAM plc (AIM: ABC;
NASDAQ: ABCM) to sell the Group's recently developed AffiDX(R)
SARS-CoV-2 research ELISA Affimer(R) reagents.
o Non-exclusive distribution agreement with Calibre Scientific
Inc. ("Calibre"), a global provider of life science products, for
Avacta's AffiDX(R) SARS-CoV-2 antigen lateral flow test for
professional use in the UK and European Economic Area (EEA).
Post-period Highlights
-- ISO13485 certification attained by Avacta Diagnostics Division.
-- Shipment of AffiDX (R) SARS-CoV-2 antigen lateral flow test commenced.
Avacta Therapeutics
Avacta Therapeutics Division becomes a clinical stage oncology
drug company receiving approval from the MHRA for its phase I,
first-in-human clinical study for AVA6000 pro-doxorubicin with the
dosing of the first patient at the Royal Marsden Hospital in August
2021.
-- Licensing agreement with Point Biopharma Inc., to provide
access to Avacta's pre|CISION(TM) technology for the development of
tumour-activated radiopharmaceuticals. Under the terms of the
agreement, Avacta has received an upfront fee and will receive
development milestone payments for the first radiopharmaceutical
prodrug totalling $9.5 million. Avacta will also receive milestone
payments for subsequent radiopharmaceutical prodrugs of up to $8
million each, a royalty on sales of FAP-activated
radiopharmaceuticals by POINT and a percentage of any sublicensing
income received by POINT.
-- MHRA approved the CTA for AVA6000 pro-doxorubicin for a phase
I, first-in-human, open label, dose-escalation and expansion study
in patients with locally advanced or metastatic selected solid
tumours. AVA6000 is Avacta's first therapeutic product based on its
proprietary pre|CISION(TM) technology.
-- Series A venture capital investment round closed for AffyXell
Therapeutics ('AffyXell'), the joint venture with Daewoong
Pharmaceuticals ('Daewoong'), raising $7.3m to further develop its
pipeline of next generation Affimer-powered cell and gene
therapies.
Post-period Highlights
-- First patient dosed in the phase I multi-centre trial
evaluating AVA6000, a novel pre|CISION(TM) pro-drug of
doxorubicin.
-- Pre-clinical milestone achieved in LG Chem Life Sciences
partnership triggering undisclosed milestone payment.
-- Dr Mark Goldberg, a medical oncologist and haematologist on
the faculty of Brigham & Women's Hospital and Harvard Medical
School, a veteran biotech executive, appointed as Non-executive
Director to the Board of Directors of Avacta.
-- Dr Fiona McLaughlin appointed as Chief Scientific Officer of the Therapeutics Division.
-- N ew appointments to the Therapeutics Scientific Advisory
Board, reflecting the progress of the Therapeutics Division and
Avacta's transition to a clinical stage Company:
o Professor James Spicer MB., BA., PhD., FRCP.
o Professor Krishnan Komanduri, MD.
o Dr Ste phane Champiat MD, PhD.
Financial Highlights
-- Cash and short-term deposits of GBP37.0 million (30 June
2020: GBP54.5 million; 31 December 2020: GBP47.9 million).
-- Revenues increased to GBP2.3 million (6 months to 30 June
2020: GBP1.8 million; year ended 31 December 2020: GBP3.6
million).
-- Operating loss of GBP11.3 million (6 months to 30 June 2020:
GBP8.1 million; y/e 31 December 2020: GBP21.3 million), with
research and amortisation of development costs increasing to GBP6.7
million (6 months to 30 June 2020: GBP4.2 million; y/e 31 December
2020: GBP10.0 million).
-- Increased R&D investment leading to reported loss of
GBP10.2 million (6 months to 30 June 2020: GBP7.0 million, y/e 31
December 2020: GBP18.9 million).
Dr Alastair Smith, Chief Executive of Avacta Group plc,
commented:
"It has been a period of very significant progress for the Group
and a transformative one for both the Diagnostics and Therapeutics
Divisions. The progress made during the reporting period has been
extraordinary, as indeed it has been over the last 18 months, under
very challenging circumstances for staff with regards to
restrictions on working conditions and the effects of the pandemic
on our lives outside work. The progress that has been made is a
reflection of the commitment and skills of our exceptional
staff.
"Significant value inflection points lie ahead of us with the
potential to transform cancer therapy with the next generation of
safer preCISION(TM) chemotherapies and Affimer immunotherapies, and
with the opportunity to generate significant profitable revenues
from the market leading AffiDX(R) SARS-CoV-2 antigen lateral flow
test and future AffiDX(R) in-vitro diagnostic products.
"We are confident and excited about the immediate and long-term
future for the Group."
-Ends-
This announcement contains information which, prior to its
disclosure, was considered inside information for the purposes of
Article 7 of Regulation (EU) No 596/2014 (MAR).
For further information from Avacta Group plc, please
contact:
Avacta Group plc Tel: +44 (0) 844 414 0452
Alastair Smith, Chief Executive Officer www.avacta.com
Tony Gardiner, Chief Financial Officer
Michael Vinegrad, Group Communications
Director
Stifel Nicolaus Europe Limited (Nomad Tel: +44 (0) 207 710 7600
and Broker) www.stifel.com
Nicholas Moore / Nick Adams / Fred
Walsh / Ben Maddison
FTI Consulting (Financial Media and Tel: +44(0) 203 727 1000
IR) Avacta.LS@fticonsulting.com
Simon Conway / Stephanie Cuthbert
Zyme Communications (Trade and Regional Tel: +44 (0)7891 477 378
Media) lily.jeffery@zymecommunications.com
Lily Jeffery
About Avacta Group plc - https://www.avacta.com
Avacta Group is developing novel cancer immunotherapies and
powerful diagnostics based on its two proprietary platforms -
Affimer(R) biologics and pre|CISION(TM) tumour targeted
chemotherapies.
The Affimer(R) platform is an alternative to antibodies derived
from a small human protein. Despite their shortcomings, antibodies
currently dominate markets, such as diagnostics and therapeutics,
worth in excess of $100bn. Affimer technology has been designed to
address many of these negative performance issues, principally: the
time taken to generate new antibodies and the reliance on an
animal's immune response; poor specificity in many cases; their
large size, complexity and high cost of manufacture.
Avacta's pre|CISION(TM) targeted chemotherapy platform releases
active chemotherapy in the tumour, which limits the systemic
exposure that causes damage to healthy tissues, and thereby
improves the overall safety and therapeutic potential of these
powerful anti-cancer treatments.
The Group comprises two divisions: The therapeutics development
activities are based in London and Cambridge, UK and the Group is
generating near-term revenues from Affimer reagents for
diagnostics, bioprocessing and research, through a separate
diagnostics business unit based in Wetherby, UK.
Avacta's Diagnostics Division is developing an in-house pipeline
of Affimer-based diagnostic assays, including the AffiDX(R)
SARS-CoV-2 Lateral Flow Rapid Antigen Test, and works with partners
world-wide to develop bespoke Affimer(R) reagents for third party
products.
Avacta's Therapeutics Division is working to deliver a more
tolerable and durable treatment response for oncology patients who
do not respond to existing immunotherapies. By combining its two
proprietary platforms the Group is building a wholly owned pipeline
of clinically differentiated cancer therapies, aiming to extend the
therapeutic benefits to all cancer patients. In 2021 Avacta
transitioned to become a clinical stage biopharmaceutical company,
commencing a phase I first-in-human, open label, dose-escalation
and expansion study of AVA6000, a pro-doxorubicin, the Group's lead
pre|CISION(TM) prodrug, in patients with locally advanced or
metastatic selected solid tumours.
Avacta has established drug development partnerships with pharma
and biotech, including a research collaboration with ModernaTX,
Inc. (formerly Moderna Therapeutics Inc.), a multi-target deal with
LG Chem worth up to $400m, a joint venture in South Korea with
Daewoong Pharmaceutical focused on cell and gene therapies
incorporating Affimer immune-modulators and a collaboration with
Point Biopharma to develop radiopharmaceuticals based on the
pre|CISION(TM) platform. Avacta continues to actively seek to
license its proprietary platforms in a range of therapeutic
areas.
To register for news alerts by email go to www.avacta.com/investor-news-email-alerts
Chairman and Chief Executive Officer's Statement
Avacta Diagnostics Division
During the reporting period the Avacta Diagnostics Division has
transformed into an ISO13485 accredited in-vitro diagnostics
product business with the CE marking and subsequent commercial
launch of the first ever Affimer-powered diagnostic product, a
SARS-CoV-2 antigen lateral flow test .
There is significant commercial potential for this rapid antigen
test in the private UK market, in Europe and further afield and the
Company believes that it is well positioned to compete in these
markets because of the test's high quality and excellent clinical
performance; its UK origins; its ability to detect the variants of
the SARS-CoV-2 virus, in particular the Delta variant; and its
convenient nasal sampling method. What is now also clear is that
these commercial opportunities will persist for a much longer
period of time than initially anticipated, with the potential for
use in a seasonal testing market.
AffiDX (R) SARS-CoV-2 Antigen Lateral Flow Test
During the reporting period the Company completed the clinical
validation of the AffiDX(R) SARS-CoV-2 antigen lateral flow test
which was shown to have 100% sensitivity for clinical samples with
Ct<=27 (considered as a high to medium infectious viral load)
and 98% sensitivity for clinical samples with Ct values up to 31
(low viral load) obtained from 98 positive COVID-19 patients. The
clinical specificity was 99% obtained from 102 negative samples.
Additional data (a further 134 negative samples) obtained more
recently has further defined the clinical specificity to be
99.6%.
These data represent key differentiating features of the
AffiDX(R) SARS-CoV-2 antigen lateral flow test, allowing the
Company to compete on performance rather than price. Details of the
transfer pricing to distributors and the price of direct sales are
confidential, but the key performance benefits allow Avacta to
competitively maintain these prices above that of cheaper
tests.
The declaration of conformity for CE mark for professional use
of the AffiDX(R) antigen test was submitted to the Medicines and
Healthcare products Regulatory Agency (MHRA) and a European
competent authority in May, and the product registration, which
allows the test to be placed on the market, was obtained in both
the UK and EU in mid-June.
Early challenges with the supply chain were quickly resolved and
the commercial roll-out of the AffiDX(R) SARS-CoV-2 antigen lateral
flow test is progressing both through direct sales and through
distributors. Avacta's direct sales efforts are focused on large
businesses, primarily but not exclusively in the UK, for workforce
testing and on a range of other users of professional use tests
such as elite professional sports teams and the travel industry.
Commercial traction is building driven by the key benefits of the
test previously described.
The first distributor for the product in the UK and Europe,
Calibre Scientific, was appointed towards the end of June in a
non-exclusive capacity. Avacta is working with additional
distributors in the Asia Pacific (APAC) region, and in other
territories, to obtain the additional local regulatory approvals to
place an IVD product with a CE mark on the market in those
territories. These approvals are expected to be received in Q4 2021
which would allow for sales in those additional territories.
It is now widely expected that SARS-CoV-2 antigen testing will
be a long-term market and will become a seasonal testing market
similar to that for influenza. The high quality and excellent
performance of the AffiDX (R) SARS-CoV-2 antigen lateral flow test
puts Avacta in a strong position to gain market share in this
long-term diagnostic market. In 2020 the total global SARS-CoV-2
antigen test market size (including PCR and other antigen test
formats) was valued at $5.3 billion and is expected to expand at a
compound annual growth rate of 6.7% from 2021 to 2027 ( source
).
The APAC region accounted for the largest portion of the market
so far for SARS-CoV-2 antigen testing, representing 37.0% of the
market in 2020(1) and, in the lateral flow testing market, there is
a shift globally towards self-testing products. These market trends
are key drivers of Avacta's AffiDX (R) SARS-CoV-2 antigen lateral
flow test commercial strategy - to expand regulatory approvals in
the APAC region and to bring a self-test product to market.
The regulatory approval of a self-test version of the AffiDX(R)
SARS-CoV-2 antigen lateral flow test is a critical milestone
because self-administered testing represents a significantly larger
commercial opportunity than professional use testing. Avacta is
working closely with its partner Medusa19 to support Medusa19's
application for a CE mark for an AffiDX(R) SARS-CoV-2 antigen
self-test. Good progress is being made in this regard with the
submission of the regulatory documentation to a notified body in
Europe. Medusa19 and Avacta are currently awaiting the response of
the notified body and will update the market when a response is
received.
The AffiDX(R) SARS-CoV-2 antigen lateral flow test is being
manufactured by Global Access Diagnostics and the transfer of this
process to Abingdon Health is now being validated to allow
commercial product to be manufactured and released. In combination
these two UK-based manufacturers will be able to supply 3-5 million
tests per month. Further capacity, if required, is being put in
place in Europe and potentially in Asia.
Avacta Therapeutics Division
The past 12 months has seen significant progress in Avacta's
Therapeutics Division with the submission and approval of a
Clinical Trial Application in the UK leading to the dosing of the
first patient in the phase I, first-in-human, open label,
dose-escalation and expansion study of its lead pre|CISION(TM)
prodrug, AVA6000, in patients with locally advanced or metastatic
selected solid tumours. This marks the transformation of Avacta
into a clinical stage oncology drug company.
AVA6000 pro-doxorubicin
Anthracyclines such as doxorubicin, a generic chemotherapy for
which the broader market is expected to grow to $1.38bn by 2024,
are widely used as part of standard of care in several tumour
types, but their use is limited by cumulative toxicity, and, in
particular, cardiotoxicity. Avacta's pre|CISION(TM) pro-drug
approach is designed to reduce the systemic exposure of healthy
tissues to the active chemotherapy, leading to improved safety and
therapeutic index, potentially resulting in improved dosing
regimens, better efficacy and better outcomes for patients.
The AVA6000 phase I clinical trial involves a dose-escalation
phase I study in patients with locally advanced or metastatic
selected solid tumours, known to be fibroblast activation protein (
FAP)-positive, in which cohorts of patients receive ascending doses
of AVA6000 to determine the maximum tolerated dose and establish a
recommended phase II dose. The second part of the study is an
expansion phase where patients receive AVA6000 to further evaluate
the safety, tolerability and clinical activity at this recommended
phase II dose across selected tumour types. For more information
visit www.clinicaltrials.gov (NCT04969835).
The first patient received their first dose of AVA6000 at The
Royal Marsden NHS Foundation Trust post-period end in early August
2021 and has now received their second and third cycles of
treatment. The phase I study is being initiated across a small
group of leading UK cancer centres with an established reputation
for early cancer clinical research in the phase I setting. The dose
escalation phase is anticipated to complete by Q2 2022 followed by
the dose expansion phase which should complete by Q2 2023.
The Company also remains on track for an IND submission before
the end of 2021 for AVA6000 for a phase I clinical trial at two
identified clinical trial sites in the US.
Pipeline of pre|CISION(TM) chemotherapies
Avacta's pre|CISION (TM) platform is a proprietary chemical
modification which renders the modified chemotherapeutic drug
inactive in the circulation until it enters the tumour
micro-environment where it is activated by an enzyme called FAP.
FAP is in high abundance in most solid tumours but not in healthy
tissues such as the heart. This is expected to lead to a
significantly greater amount of active drug in the tumour tissue
compared with healthy tissues and a concomitant improvement in
tolerability for patients and better clinical outcomes.
If the AVA6000 study shows that the pre|CISION (TM) chemistry is
effective in reducing systemic toxicity of Doxorubicin in humans,
then it can be applied to a range of other established
chemotherapies to improve their safety and efficacy. This would be
a significant value inflection point since it would open up a
pipeline of next generation of safer chemotherapies for the Group
with significant clinical and commercial value in a chemotherapy
market that is expected to grow to $56 billion by 2024.
The next most advanced pre|CISION (TM) pro-drug is AVA3996, a
FAP-activated analogue of Velcade, Takeda's proteasome inhibitor
which comes off patent in 2022. The global proteasome inhibitors
market size is expected to be worth $1.7 billion by 2023 ( source )
and Velcade represents just over half of that market. As with all
chemotherapies the benefit of these drugs is limited by toxicities
and tolerability for patients. In the case of Velcade, there are
significant side effects such as peripheral neuropathy which has
limited its approval, principally to multiple myeloma. A
potentially safer proteasome inhibitor, such as AVA3996, could win
significant market share for the treatment of multiple myeloma and
also be used to treat solid tumours, such as pancreatic cancer.
Pancreatic cancer also exhibits the highest level of FAP activity
of any solid tumour and therefore a FAP activated pro-drug could
have significant potential in this area of high unmet need.
Excellent progress has been made in the AVA3996 programme which
remains on track for clinical development candidate selection by
the end of 2021. A number of in-vivo studies aimed at de-risking
the pre-clinical and clinical development of AVA3996 have been
completed. A contract manufacturing organisation for the drug
substance and drug product has been identified and the Company is
investigating potential fast-track approval options.
A longer term pipeline of preCISION pro-drug chemotherapies is
in the Company's early research pipeline working closely with
Professor Bill Bachovchin's group at Tufts University Medical
School.
Affimer Immunotherapy Programmes
One of the highest priorities for Avacta's Therapeutics Division
is to translate the Affimer (R) platform into human and demonstrate
the safety and tolerability of this novel therapeutic protein
platform.
In the oncology field it has become clear in recent years that
cancer immunotherapies used singly, so-called 'monotherapies', have
limited overall response rates. The Company's Affimer (R)
immunotherapy strategy is to harness the benefits of the Affimer
(R) platform to build bispecific drug molecules that can hit two
drug targets simultaneously and to use Affimer (R) molecules to
target toxic payloads using conventional and pre|CISION(TM)
linkers.
Steady progress has been made with the in-house Affimer(R)
bispecific programmes towards selection of a clinical development
candidate as quickly as possible. The two lead programmes build
upon the AVA004 PD-L1 antagonist; these are AVA027, a PD-L1/TGF-
receptor trap combination, and AVA028, a PD-L1/IL2 bispecific.
As a result of the clinical data from Merck KGaA and their
Bintrafusp alfa (a dual TGF-beta/PD-L1 inhibitor antibody), the
Company has decided to pause the AVA027 programme. This will afford
the Company time to further understand the issues arising in the
Bintrafusp alfa clinical trials and whether they are related to the
trial design, and can therefore potentially be dealt with by better
trial design, or whether there is a more fundamental issue with
this bispecific combination. In the meantime, the Company is using
this pause to focus resources on AVA028 to deliver an Affimer (R)
development candidate as quickly as possible.
AVA028 combines an Affimer PD-L1 antagonist with IL-2 which is a
cytokine that plays a signalling role in expanding the number of
activated immune cells (T and NK cells). IL-2 has been developed as
a stand-alone cancer therapy, but it suffers from challenging
systemic toxicity and therefore the concept of AVA028 is to combine
IL-2 with a PD-L1 inhibitor in a bispecific drug molecule to not
only support the immune response in the tumour through blocking of
the PD-L1 / PD-1 interaction but also to help target the IL-2 to
tumours which have an increased level of PD-L1 compared with
healthy tissue.
Good progress has been made in the AVA028 programme. Lead
candidate molecules have demonstrated in-vivo activity in a pilot
efficacy study. Further in-vivo efficacy and safety studies have
been initiated to confirm dose selection for further non-clinical
in-vivo studies and ultimately for a clinical first-in-human study.
A clinical development candidate selection decision is planned for
H1 2022.
TMAC (R) and other drug conjugates
Drug conjugates use a chemical linker to combine a toxic payload
such as a chemotoxin or radioligand with a targeting system such as
an Affimer(R) or antibody that binds to a cancer biomarker usually
on the surface of tumour cells. Conventional drug conjugates target
a biomarker that is frequently internalised by the tumour cells
taking with it the drug conjugate where the toxic payload is
released by enzymatic breakdown of the linker. The tumour
microenvironment activated drug conjugate (TMAC(R) ) uses the
pre|CISION(TM) chemistry in the linker so that the toxic payload
can be released outside the tumour cell in the tumour
microenvironment allowing different, synergistic, mechanisms of
action to be envisioned between the toxin and the targeting system
which could have immunotherapeutic properties. TMAC(R) is a new
class of drug conjugate for which the Company has made a patent
application with Tufts University Medical School.
In-vivo studies of the lead TMAC(R) programmes are ongoing to
support the selection of a clinical development candidate from the
pipeline. The first of these programmes is AVA04-VbP, a TMAC(R)
combining a PD-L1 Affimer(R) antagonist with a powerful
chemotherapy called AVA100 I-DASH (also known as Val-boro-Pro
(VbP)) that kills macrophage in the tumour microenvironment leading
to a significant inflammatory event that attracts the immune system
to the tumour. The postulated mechanism of action is that the
immune response to the pro-inflammatory cell killing in the tumour
is then supported by the presence of the Affimer(R) PD-L1 blockade.
The second TMAC(R) programme combines an Affimer(R) against an
undisclosed target with VbP. These in-vivo studies will continue
through 2021 with potential to select the first TMAC(R) drug
candidate during 2022 for pre-clinical and clinical
development.
The Therapeutics Division is also reviewing conventional drug
conjugate opportunities that leverage the key benefits of the
Affimer (R) platform to deliver toxic payloads into tumour
cells.
Partnered programmes
LG Chem Life Sciences : Very good progress has been made in our
strategic partnership with LG Chem Life Sciences towards the
clinical development of a novel checkpoint inhibitor utilising the
Affimer (R) platform. LG Chem Life Sciences has recently committed
to move from the discovery phase into pre-clinical develop and
ultimately IND-enabling studies with a PD-L1 antagonist candidate
drug molecule utilising Afffimer XT(R) half-life extension. This is
a major step forwards in our close collaboration with LG Chem Life
Sciences and moves the Affimer (R) platform significantly closer to
the clinic.
AffyXell : AffyXell is an Affimer-engineered cell therapy joint
venture with Daewoong Pharmaceuticals in South Korea. During the
reporting period AffyXell closed a Series A round of $7.3m with a
syndicate of venture capital firms including Samsung Venture
Investment Corporation. The company has made excellent progress,
advancing both its GMP-compliant human mesenchymal stem cell
technology and its Affimer (R) discovery programs against two of
the three initial targets. Proof-of-concept studies are planned for
2022 to form the basis for a Series B fund raise to move candidate
cell therapies into the clinic.
Moderna: In 2019 Moderna exercised a commercial option to an
Affimer (R) programme and took a number of lead Affimer molecules
against that particular target in-house for development. Avacta is
not actively involved with this ongoing internal development work
at Moderna. The next key milestone would occur if Moderna submits
an IND package to the FDA.
ADC Therapeutics : Avacta has provided Affimer (R) molecules to
ADC Therapeutics under the evaluation agreement. This evaluation
agreement has now concluded, and ADC Therapeutics is not taking
this programme further.
Chief Scientific Officer and Scientific Advisory Board
The Therapeutics Division has made a series of new appointments
in recent months with Dr Fiona McLaughlin joining as Chief
Scientific Officer and with several appointments to its Scientific
Advisory Board (SAB), reflecting Avacta's transition to a clinical
stage oncology drug company.
Dr McLaughlin is a highly experienced oncology drug developer,
bringing over 25 years' experience in research and translational
drug development in the pharmaceutical and biotech sectors, having
led teams from early research through to clinical development.
Fiona started her career at GlaxoSmithKline and has subsequently
held leadership positions in multiple biotech companies including
Vice President, Translational Research at Antisoma plc and Director
of Pre-clinical Development at BTG plc (now part of Boston
Scientific).
Other roles include Head of Biology at TopoTarget A/S, where she
was responsible for the pre-clinical development of belinostat
which went on to gain FDA approval to treat peripheral T-cell
lymphoma. Most recently, Fiona was Vice President of New
Opportunities at Algeta ASA (acquired by Bayer), a Norwegian
biotech developing alpha radio-pharmaceuticals, that gained FDA
approval of Xofigo to treat castration resistant prostate
cancer.
Fiona has also gained broad experience during her career as a
Consultant, providing scientific and strategic advice to biotechs,
Not-for-Profit Organisations, and Venture Capitalists in UK,
Europe, USA and Australia, including helping drive oncology
strategy at the CRUK/AstraZeneca Alliance Laboratory. Fiona
received a PhD from the Haematology Department at Cambridge
University and has a BSc in Biochemistry from Glasgow
University.
The SAB provides the Therapeutics Division with scientific and
clinical advice to support its drug development decision making and
pipeline strategy. The three new members of the SAB are Professor
James Spicer MB., BA., PhD., FRCP, Professor Krishnan Komanduri,
MD, and Dr Ste phane Champiat MD, PhD.
James Spicer is Professor of Experimental Cancer Medicine at
King's College London and Consultant in Medical Oncology at Guy's
& St. Thomas' Hospitals, London. He has established and runs a
world-leading Phase 1 clinical trials programme in solid tumour
oncology at Guy's Hospital, where the portfolio of studies includes
novel immunotherapies discovered and developed at King's as well as
many externally sponsored studies.
Krishna Komanduri is Chief of the Division of Transplantation
and Cellular Therapy, and Associate Chief Medical Officer for
Clinical Innovation, at the Sylvester Comprehensive Cancer Center,
Miami. He is also a Professor of Medicine, Microbiology and
Immunology and a physician-scientist with a laboratory focusing on
T-cell immunology in cancer. Dr. Komanduri serves on the United
Health Care Oncology Advisory Committee and is a past Chair of the
American Society of Hematology Scientific Committee on Host
Defense, is the current Chair of the ASTCT Cellular Therapy
Committee and Chair-Elect of the Government Relations
Committee.
Ste phane Champiat MD, PhD is a physician at the Gustave Roussy
Cancer Center in Paris, where he focuses on the development of
cancer therapeutics, in particular, new immunotherapies. He has
been principal investigator or co-investigator of more than 50
Phase I clinical trials run by many of the world's leading
pharmaceutical and biotech companies. He is particularly involved
in the coordination of the immunotherapy toxicity management
program and the development of the intra-tumoral immunotherapy
strategy at Gustave Roussy.
Avacta Animal Health Division
Avacta Animal Health provides specialised laboratory services to
veterinary professionals worldwide.
Trading over the reporting period has improved following the
re-focus of the business on its core product and service offerings
around allergy and therapy testing with growth in the UK and
overseas. Revenues for the period were GBP0.81 million compared to
GBP0.68 million in the comparable period in 2020. Operating costs
for the business have been reduced following the changes made last
year and this has seen the business achieve an operating break-even
position compared to an operating loss of GBP0.27 million in the
comparable period.
Trading since the end of the reporting period continues to
improve as the business strengthens its position providing
veterinary testing services, contract research services and sales
of laboratory testing kits in the UK and overseas.
Financial Review
Revenue for the 6 months ended 30 June 2021 increased to GBP2.32
million compared to the same period in 2020 (6 months to 30 June
2020: GBP1.81 million; year ended 31 December 2020: GBP3.64
million).
Revenue contribution from the Group's Therapeutics Division
increased to GBP1.43 million (6 months to 30 June 2020: GBP0.80
million; year ended 31 December 2020: GBP1.63 million) due to the
continuation of funded research projects and certain milestone
payments. Revenue from the Diagnostic Division decreased to GBP0.09
million (6 months to 30 June 2020: GBP0.34 million; year ended 31
December 2020: GBP0.52 million) as resources were focused on the
development and launch of the AffiDX(R) SARS-CoV-2 antigen lateral
flow test with a reduced number of custom projects during the
period. Revenues from Avacta Animal Health, the allergy and
diagnostic testing business, increased to GBP0.81 million (6 months
to 30 June 2020: GBP0.68 million; year ended 31 December 2020:
GBP1.49 million).
Research costs from the development of the AffiDX(R) SARS-CoV-2
antigen lateral flow test and the expanding Therapeutics Division
increased to GBP6.29 million (6 months to 30 June 2020: GBP3.57
million; year ended 31 December 2020: GBP8.96 million), as the
Company continues to make significant investments in the Affimer
(R) and pre|CISION(TM) therapeutics programmes.
Selling, general and administrative costs have increased to
GBP4.06 million (6 months to 30 June 2020: GBP3.14 million; year
ended 31 December 2020: GBP7.32 million). Depreciation has also
increased to GBP0.65 million (6 months to 30 June 2020: GBP0.52
million; year ended 31 December 2020: GBP1.13 million). Share-based
payment charges have remained constant at GBP1.44 million (6 months
to 30 June 2020: GBP1.44 million; year ended 31 December 2020:
GBP3.11 million).
Amortisation of development costs has reduced to GBP0.41 million
(6 months to 30 June 2020: GBP0.66 million; year ended 31 December
2020: GBP1.00 million) as the research and development costs for
the AffiDX(R) SARS-CoV-2 antigen lateral flow test and the
pre-clinical development costs of the Therapeutics Division have
been expensed during the period. The value of intangible assets on
the balance sheet, which includes capitalised development costs and
goodwill has reduced from the prior year end as a result of the
amortisation to GBP9.07 million (30 June 2020: GBP12.02 million; 31
December 2020: GBP9.42 million).
The Group's operating loss increased to GBP11.34 million (6
months to 30 June 2020: GBP8.11 million; year ended 31 December
2020: GBP21.29 million) and the reported loss after taxation
increased to GBP10.20 million (6 months to 30 June 2020: GBP6.99
million; year ended 31 December 2020: GBP18.89 million).
The basic loss per share increased to 4.09p (6 months to 30 June
2020: 3.74p; year ended 31 December 2020: 8.37p) due to the
increase in reported losses.
There was a cash outflow from operations and working capital
movements of GBP10.20 million (6 months to 30 June 2020: GBP4.39
million; year ended 31 December 2020: GBP13.35 million) and an
outflow from investing activities (excluding movements on
short-term deposits) of GBP0.80 million on capital expenditure and
capitalised development costs (6 months to 30 June 2020: GBP1.02
million; year ended 31 December 2020: GBP1.88 million). Cash inflow
from financing activities, being amounts received from the issue of
shares and exercise of share options net of lease payments amounted
to GBP0.11 million (6 months to 30 June 2020: inflow GBP51.09
million; year ended 31 December 2020: inflow GBP51.65 million). The
Group ended the period with GBP36.97 million net cash and
short-term deposits (30 June 2020: GBP54.45 million; 31 December
2020: GBP47.91 million).
Our people
We wish to acknowledge the continuing effort and commitment of
our staff in what has continued to be difficult circumstances
during the first half of 2021. We would like to thank them again
for their hard work and commitment that has led to the success of
all the Group's businesses and has delivered significant progress
towards numerous major value inflection points.
Effects of the COVID-19 pandemic
The Board continues to monitor and assess the impact of the
COVID-19 pandemic on staff and on the Group's businesses.
The Diagnostics Division has launched a high-performance
SARS-CoV-2 antigen lateral flow test and expects to see significant
revenue from sales of that product for a number of years. The
intense focus of technical resources on the SARS-CoV-2 lateral flow
test product development and the establishment of the Quality
Management System that supported the ISO13485 certification, is now
being eased and the business can turn the majority of its technical
resources to future product development that will underpin
non-COVID-19 related future revenue.
During the reporting period the Therapeutics Division overcame
the limitations on working practices imposed by the pandemic and
did not experience any significant delays with sub-contractors or
regulatory bodies, allowing it to successfully initiate the phase I
clinical study of AVA6000 in August 2021. The business is not
currently expecting to see any significant effects on the ability
of the phase I clinical trial sites to recruit patients but there
remains a potential risk of delays in this regard through the
autumn and winter.
Outlook
The Group has made strong progress during the reporting period,
and over the past 18 months, despite the additional pressures and
restrictions imposed on the businesses by the pandemic. This is a
testament to the commitment and hard work of our staff, and we will
continue to invest in them through training, development, and an
active focus on organisational mental health to continue to drive
performance.
The Board believe that the most significant near-term value
driver for the Group is the clinical data from the phase I study of
AVA6000. The pre|CISION prodrug approach has the potential to
complement chemotherapy and to create new oncology treatments that
are affordable for all. If the pre|CISION platform is shown to
improve the safety of Doxorubicin in the AVA6000 phase I study then
it not only creates a significant commercial opportunity for the
Group with a proprietary safer form of Doxorubicin, but also opens
up a large, and very valuable, pipeline of future pre|CISION(TM)
chemotherapy prodrugs.
The Diagnostics Division has launched its first Affimer-powered
in-vitro diagnostic product, the AffiDX(R) SARS-CoV-2 antigen
lateral flow test which has raised the global profile of the
Affimer platform and the Group immensely. It is clear that the
Diagnostics Division has the potential to generate significant
revenue from sales of this product over a longer period than
originally anticipated, creating the basis for a profitable
Diagnostics Division. The team will continue to expand its
distributor network and extend the regulatory approvals outside of
the UK and EU to drive sales over the longer term and will scale
its manufacturing capacity as required to meet demand, as well as
develop a pipeline of additional in-vitro diagnostic products.
In the next 12 months we expect to see further strong progress
in both Divisions and anticipate several significant value
inflection points to be achieved.
Dr Eliot Forster Dr Alastair Smith
Chairman Chief Executive Officer
30 September 2021 30 September 2021
Condensed Consolidated Statement of Profit or Loss
for the 6 months ended 30 June 2021
Unaudited Unaudited Audited
6 months ended 6 months ended 30 June 2020 Year ended
30 June 2021 31 December 2020
GBP000 GBP000 GBP000
Revenue 2,321 1,810 3,636
Cost of sales (811) (586) (1,455)
--------------- ---------------------------- ------------------
Gross profit 1,510 1,224 2,181
Research costs (6,285) (3,574) (8,961)
Share of loss of associate - - (217)
Amortisation of development costs (410) (664) (1,007)
Impairment of intangible fixed assets - - (1,741)
Selling, general and administrative expenses (4,062) (3,141) (7,315)
Depreciation expense (652) (515) (1,125)
Share-based payment charge (1,438) (1,435) (3,108)
----------------------------
Operating loss (11,337) (8,105) (21,293)
Finance income 13 15 43
Finance costs (72) (28) (93)
----------------------------
Net finance costs (59) (13) (50)
Loss before tax (11,396) (8,118) (18,891)
Taxation 1,199 1,124 2,452
Loss and total comprehensive loss for the
period (10,197) (6,994) (18,891)
--------------- ---------------------------- ------------------
Loss per ordinary share:
* Basic and diluted (4.09p) (3.74p) (8.37p)
All activities relate to the continuing operations of the
Group.
Condensed Consolidated Statement of Financial Position
as at 30 June 2021
Unaudited Unaudited Audited
As at As at As at
30 June 2021 30 June 2020 31 December 2020
GBP000 GBP000 GBP000
Assets
Property, plant, and equipment 2,920 2,020 2,696
Right-of-use assets 1,937 678 2,095
Intangible assets 9,069 12,018 9,417
-------------- -------------- ------------------
Non-current assets 13,926 14,715 14,208
-------------- -------------- ------------------
Inventories 222 161 248
Trade and other receivables 5,786 2,176 2,895
Income tax receivable 3,400 3,625 2,200
Short-term deposits 5,023 - 20,017
Cash and cash equivalents 31,951 54,451 27,894
Current assets 46,382 60,413 53,254
-------------- -------------- ------------------
Total assets 60,308 75,128 67,462
-------------- -------------- ------------------
Liabilities
Lease liabilities (1,599) (568) (1,752)
-------------- -------------- ------------------
Non-current liabilities (1,599) (568) (1,752)
-------------- -------------- ------------------
Trade and other payables (4,979) (2,969) (3,491)
Lease liabilities (300) (164) (290)
-------------- -------------- ------------------
Current liabilities (5,279) (3,133) (3,781)
-------------- -------------- ------------------
Total liabilities (6,878) (3,701) (5,533)
-------------- -------------- ------------------
Net assets 53,430 71,427 61,929
-------------- -------------- ------------------
Equity attributable to equity holders of the Company
Share capital 25,443 24,957 25,343
Share premium 54,297 53,797 54,137
Other reserve (1,729) (1,729) (1,729)
Reserve for own shares (2,961) (2,961) (2,961)
Retained earnings (21,620) (2,637) (12,861)
-------------- -------------- ------------------
Total equity 53,430 71,427 61,929
-------------- -------------- ------------------
Total equity is wholly attributable to equity holders of the
parent Company.
Approved by the Board and authorised for issue on 30 September
2021.
Dr Alastair Smith Tony Gardiner
Chief Executive Officer Chief Financial Officer
Condensed Consolidated Statement of Changes in Equity
for the 6 months ended 30 June 2021
Unaudited Unaudited Unaudited Unaudited Unaudited Unaudited
Share Share premium Other Reserve for own Retained earnings Total Equity
Capital reserve shares
GBP000 GBP000 GBP000 GBP000 GBP000 GBP000
--------------------- ---------- -------------- ---------- -------------------- ------------------ -------------
At 1 January 2020 17,671 9,877 (1,729) (2,932) 2,922 25,809
Total comprehensive
loss for the period - - - - (6,994) (6,994)
Total transactions
with owners of the
company:
Issue of shares 7,194 43,597 - - - 50,791
Exercise of options 82 304 - - - 386
Own shares acquired 10 19 - (29) - -
Equity-settled
share-based payment - - - - 1,435 1,435
At 30 June 2020 24,957 53,797 (1,729) (2,961) (2,637) 71,427
--------------------- ---------- -------------- ---------- -------------------- ------------------ -------------
Total comprehensive loss for the period - - - - (11,897) (11,897)
Total transactions with owners of the company:
Exercise of options 386 340 - - - 726
Equity-settled share-based payment - - - - 1,673 1,673
At 31 December 2020 25,343 54,137 (1,729) (2,961 (12,861) 61,929
------------------------------------------------ ------- ------- -------- -------- --------- ---------
Total comprehensive loss for the period - - - - (10,197) (10,197)
Total transactions with owners of the company:
Exercise of options 100 160 - - - 260
Equity-settled share-based payment - - - - 1,438 1,438
At 30 June 2021 25,443 54,297 (1,729) (2,961) (21,620) 53,430
------------------------------------------------ ------- ------- -------- -------- --------- ---------
Condensed Consolidated Statement of Cash Flows
for the 6 months ended 30 June 2021
Unaudited Unaudited Audited
6 months ended 6 months ended Year ended
30 June 2021 30 June 2020 31 December
2020
GBP000 GBP000 GBP000
Cash flow from operating activities
Loss for the period (10,197) (6,994) (18,891)
Adjustments for:
Amortisation 428 675 1,029
Impairment losses - - 1,741
Depreciation 652 515 1,125
Net (gain) / loss on disposal
of property, plant, and equipment - (1) 6
Share of loss of associate - - 217
Equity-settled share-based payment charges 1,438 1,435 3,108
Net finance costs 58 13 50
Taxation (1,199) (1,124) (2,452)
---------------
Operating cash outflow before changes in working capital (8,820) (5,481) (14,067)
Decrease / (increase) in inventories 26 (4) (91)
Increase in trade and other receivables (2,888) (95) (814)
Increase in trade and other payables 1,486 1,192 1,627
--------------- --------------- -------------
Operating cash outflow from operations (10,196) (4,388) (13,345)
Interest received 13 15 42
Interest elements of lease payments (66) (29) (93)
Tax credit received - - 2,754
Net cash used in operating activities (10,249) (4,402) (10,642)
--------------- --------------- -------------
Cash flows from investing activities
Purchase of plant and equipment (718) (128) (1,279)
Purchase of intangible assets (81) (3) (221)
Investment in associate - - (217)
Development expenditure capitalised - (889) (165)
Decrease/(increase) in balances on short-term deposit 14,994 - (20,017)
Net cash used in investing activities 14,195 (1,020) (21,899)
--------------- --------------- -------------
Cash flows from financing activities
Proceeds from issue of new shares - 53,750 53,750
Transaction costs related to issue of share capital** - (2,960) (2,960)
Proceeds from exercise of share options 259 386 1,112
Principal elements of lease payments (148) (91) (255)
--------------- --------------- -------------
Net cash flow from financing activities 111 51,085 51,647
--------------- --------------- -------------
Net increase/(decrease) in cash and cash equivalents 4,057 45,663 19,106
Cash and cash equivalents at the beginning of the period 27,894 8,788 8,788
--------------- --------------- -------------
Cash and cash equivalents at the end of the period 31,951 54,451 27,894
--------------- --------------- -------------
** Please see Note 1 for further information
Notes to the unaudited condensed consolidated financial
statements
for the 6 months ended 30 June 2021
1) Basis of preparation
Avacta Group plc ('the Company') is a company incorporated in
England and Wales under the Companies Act 2006. These condensed
consolidated interim financial statements ('interim financial
statements') as at and for the 6 months ended 30 June 2021 comprise
the Company and its subsidiaries (together referred to as 'the
Group').
The interim financial statements for the 6 months ended 30 June
2021 are unaudited. This information does not constitute statutory
accounts as defined in Section 435 of the Companies Act 2006. The
financial figures for the year ended 31 December 2020, as set out
in this report, do not constitute statutory accounts but are
derived from the statutory accounts for that financial year. The
statutory accounts for the year ended 31 December 2020 were
prepared under IFRS and have been delivered to the Registrar of
Companies. The auditors reported on those accounts. Their report
was unqualified, did not draw attention to any matters by way of
emphasis and did not include a statement under Section 498 of the
Companies Act 2006.
The Board confirms that, to the best of its knowledge, these
condensed financial statements have been prepared in accordance
with IAS34 Interim Financial Reporting and should be read in
conjunction with the Group's last annual consolidated financial
statements as at and for the year ended 31 December 2020 ('last
annual financial statements'). They do not include all the
financial information required for a complete set of IFRS financial
statements. 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 financial statements.
In the prior interim period, the Consolidated Statement of Cash
Flows presented proceeds from the issue of share capital net of
transaction costs related to the issue of share capital as
GBP50,790,000.
The Board approved these interim financial statements for issue
on 30 September 2021.
2) Use of judgements and estimates and significant accounting policies
The preparation of the interim financial statements requires
management to make judgements and estimates that affect the
application of accounting policies and the reported amounts of
assets and liabilities, income, and expense. Although these
estimates are based on management's best knowledge of the amount,
events or actions, actual events ultimately may differ from those
estimates.
The significant judgements made by management in applying the
Group's accounting policies, and the key sources of estimation
uncertainty were the same as those described in the last annual
financial statements.
The accounting policies applied in these interim financial
statements are the same as those applied in the Group's
consolidated financial statements as at and for the year ended 31
December 2020. A number of new standards are effective from 1
January 2021, but they do not have a material effect on the Group's
financial statements.
3) Segmental reporting
The Group has three distinct operating segments: Diagnostics,
Therapeutics and Animal Health. These are the reportable operating
segments in accordance with IFRS 8 Operating Segments. The
Directors recognize that the operations of the Group are dynamic
and therefore this position will be monitored as the Group
develops.
Segment revenue represents revenue from external customers
arising from sale of goods and services, plus inter-segment
revenues. Inter-segment transactions are priced on an arm's length
basis. Segment results, assets and liabilities include items
directly attributable to a segment as well as those that can be
allocated on a reasonable basis.
The Group's revenue to destinations outside the UK amounted to
77% (6 months to 30 June 2020: 73%; year to 31 December 2020: 70%).
The revenue analysis below is based on the country of registration
of the customer:
6 months ended 30 June 2021 6 months ended 30 June 2020 Year ended 31 December 2020
GBP000
UK 542 483 1,076
Rest of Europe 292 328 685
North America 748 239 402
Asia 739 759 1,473
2,321 1,810 3,636
---------------- ---------------------------- ---------------------------- ----------------------------
The central overheads, which primarily relate to the operation
of the Group function are not allocated to the operating
segments.
Operating segment analysis for the six months ended 30 June
2021
Diagnostics Therapeutics Animal
Health Total
GBP000 GBP000 GBP000 GBP000
Revenue 91 1,425 805 2,321
Cost of goods sold (50) (497) (264) (811)
------------- ------------- ------------- -------------
Gross profit 41 928 541 1,510
Research costs (2,068) (4,190) (27) (6,285)
Amortisation of development costs (410) - - (410)
Selling, general and administrative expenses (1,232) (869) (483) (2,584)
Depreciation expense (248) (376) (25) (649)
Share-based payment expense (371) (390) (17) (778)
------------- ------------- ------------- -------------
Segment operating loss (4,288) (4,897) (11) (9,196)
Central overheads (2,141)
------------- ------------- ------------- -------------
Operating loss (11,337)
Finance income 13
Finance expense (72)
-------------
Loss before taxation (11,396)
Taxation 1,199
-----------
Loss for the period (10,197)
-----------
Operating segment analysis for the six months ended 30 June
2020
Diagnostics Therapeutics Animal
Health Total
GBP000 GBP000 GBP000 GBP000
Revenue 337 795 678 1,810
Cost of goods sold (169) (192) (226) (587)
------------- ------------- ------------- -------------
Gross profit 168 603 452 1,223
Research costs (12) (3,543) (19) (3,574)
Amortisation of development costs (549) - (114) (664)
Selling, general and administrative expenses (1,151) (611) (553) (2,315)
Depreciation expense (142) (255) (14) (411)
Share-based payment expense (371) (389) (17) (777)
------------- ------------- ------------- -------------
Segment operating loss (2,057) (4,195) (265) (6,517)
Central overheads (1,588)
------------- ------------- ------------- -------------
Operating loss (8,105)
Finance income 15
Finance expense (28)
-------------
Loss before taxation (8,118)
Taxation 1,124
-----------
Loss for the period (6,994)
-----------
Operating segment analysis for the year ended 31 December
2020
Diagnostics Therapeutics Animal
Health Total
GBP000 GBP000 GBP000 GBP000
Revenue 519 1,625 1,492 3,636
Cost of goods sold (321) (641) (493) (1,455)
------------- ------------- ------------- -------------
Gross profit 198 984 999 2,181
Research costs (2,458) (6,432) (71) (8,961)
Share of loss of associate - (217) - (217)
Amortisation of development costs (824) - (183) (1,007)
Selling, general and administrative expenses (2,525) (1,702) (966) (5,193)
Impairment charge - - (1,741) (1,741)
Depreciation expense (357) (701) (62) (1,120)
Share-based payment expense (636) (893) (38) (1,567)
------------- ------------- ------------- -------------
Segment operating loss (6,602) (8,961) (2,062) (17,625)
Central overheads (3,668)
------------- ------------- ------------- -------------
Operating loss (21,293)
Finance income 43
Finance expense (93)
-------------
Loss before taxation (21,343)
Taxation 2,452
Loss for the period -------------
(18,891)
-----------
4) Revenue
The Group's operations and main revenue streams are those
described in the last annual financial statements. The Group's
revenue is all derived from contracts with customers.
Disaggregation of revenue
In the following table, revenue is disaggregated by its nature.
The table also includes a reconciliation of the disaggregated
revenue with the Group's reportable segments (see Note 4).
Six months ended 30 June 2021
GBP'000 Diagnostics Therapeutics Animal Health Total
------------------------ ------------ ------------- -------------- ------
Nature of revenue
Sale of goods - - 462 462
Provision of services 91 689 343 1,123
Licence-related income - 736 - 736
------------------------ ------------ ------------- -------------- ------
91 1,425 805 2,321
------------------------ ------------ ------------- -------------- ------
Six months ended 30 June 2020
GBP'000 Diagnostics Therapeutics Animal Health Total
------------------------ ------------ ------------- -------------- ------
Nature of revenue
Sale of goods - - 392 392
Provision of services 337 795 285 1,417
Licence-related income - - - -
------------------------ ------------ ------------- -------------- ------
337 795 677 1,809
------------------------ ------------ ------------- -------------- ------
Year ended 31 December 2020
GBP'000 Diagnostics Therapeutics Animal Health Total
------------------------ ------------ ------------- -------------- ------
Nature of revenue
Sale of goods - - 846 846
Provision of services 519 1,436 646 2,601
Licence-related income - 189 - 189
------------------------ ------------ ------------- -------------- ------
519 1,625 1,492 3,636
------------------------ ------------ ------------- -------------- ------
5) Earnings per share
Unaudited Unaudited Audited
6 months ended 30 June 6 months ended 30 June Year ended 31 December
2021 2020 2020
Loss (GBP000) 10,197 6,994 18,891
--------------------------- --------------------------- ---------------------------
Weighted average number of
shares (number) 249,127,610 187,187,754 225,578,759
--------------------------- --------------------------- ---------------------------
Basic and diluted loss per
ordinary share (p) (4.09) (3.74) (8.37)
--------------------------- --------------------------- ---------------------------
6) Standards issued but not yet effective
A number of new standards and amendments to standards are
effective for annual periods beginning after 1 January 2021 and
earlier application is permitted; however, the Group has not early
adopted any of the forthcoming new or amended standards in
preparing these condensed consolidated interim financial
statements.
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