Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM) today reports its
financial results for the fourth quarter and fiscal year ended 31
January 2018 and provides an update on operational progress.
Mr Glyn Edwards, Chief Executive Officer
of Summit, commented: “This was a landmark year for
Summit’s Duchenne muscular dystrophy programme where we saw a
statistically significant reduction in muscle damage and
inflammation in patients after just 24-weeks of ezutromid
treatment. This provides evidence that ezutromid is reducing the
severity of the disease for these patients.
“Strongly encouraged by these findings, we are
accelerating preparatory activities for a placebo controlled trial
of ezutromid and also preparing for a potential regulatory filing
of ezutromid based on top-line data from the full 48-week results,
which are expected in the third quarter of 2018.
“Our infectious disease business has also made
major strides over the past year. With funding support from BARDA,
we are preparing to initiate our Phase 3 trials for ridinilazole, a
precision antibiotic for the treatment of C. difficile infections.
Based on the discovery and development platform we acquired in
2017, we are also building a pipeline of new mechanism antibiotics
as we position ourselves as leaders in the field of
antibacterials.
“With two lead clinical programmes in DMD and
CDI, and a growing pipeline of early-stage compounds, we are
building a fully-integrated company focused on advancing novel
mechanism drugs as new standards of care.”
Rare Diseases
Highlights
- Announced positive 24-week interim data from PhaseOut DMD, a
Phase 2 proof of concept trial of ezutromid in patients with DMD,
which showed evidence of activity across three different measures.
Specifically, ezutromid:
- Maintained the production of utrophin, a naturally occurring
protein that can potentially substitute for dystrophin.
- Significantly and meaningfully reduced muscle damage.
- Significantly reduced muscle inflammation.
- Accelerating preparatory activities for a placebo controlled
clinical trial for ezutromid, and for a potential regulatory filing
of ezutromid based on the 48-week results from PhaseOut DMD.
- Received a $22 million milestone payment from our strategic
partner, Sarepta Therapeutics, for the completion of enrolment in
PhaseOut DMD.
- Maintaining leadership in utrophin modulation through our
strategic alliance with the University of Oxford to identify
utrophin modulator candidates.
Infectious Diseases
Highlights
- Awarded a contract worth up to $62 million from Biomedical
Advanced Research and Development Authority (‘BARDA’) to support
the clinical and regulatory development of ridinilazole for the
treatment of CDI.
- Outlined ridinilazole Phase 3 clinical programme following
input from the US Food and Drug Administration and European
Medicines Agency. The trials are expected to start in Q1 2019.
- Obtained a proprietary infectious disease discovery and
development platform through the acquisition of Discuva Limited in
December 2017, positioning Summit as a leader in the research and
development of new classes of antibiotics; in March 2018, announced
identification of novel mechanism antibiotic compounds for the
treatment of gonorrhoea using this platform.
Financial Highlights
- Cash and cash equivalents at 31 January 2018 of £20.1 million
compared to £28.1 million at 31 January 2017.
- In March 2018 (post fiscal year end), raised gross proceeds of
£15.0 million ($21.2 million*) through a placing of new ordinary
shares to investors in Europe.
- Loss for the year ended 31 January 2018 of £7.1 million
compared to a loss of £21.4 million for the year ended 31 January
2017.
Conference Call and Webcast
InformationSummit will host a conference call and webcast
to review the financial results for the fiscal year ended 31
January 2018 today at 1:00pm BST / 8:00am EDT. To participate in
the conference call, please dial +44 (0)330 336 9411 (UK and
international participants) or +1 646 828 8156 (US local number)
and use the conference confirmation code 1980085. Investors may
also access a live audio webcast of the call via the investors
section of the Company’s website, www.summitplc.com. A replay of
the webcast will be available shortly after the presentation
finishes.
About Summit TherapeuticsSummit
is a biopharmaceutical company focused on the discovery,
development and commercialisation of novel medicines for
indications for which there are no existing or only inadequate
therapies. Summit is conducting clinical programmes focused on the
genetic disease Duchenne muscular dystrophy and the infectious
disease C. difficile infection. Further information is available at
www.summitplc.com and Summit can be followed on Twitter
(@summitplc).
*Based on a conversion rate of US$1.4135 to
£1.00
This announcement contains inside information for the purposes
of Article 7 of EU Regulation 596/2014 (MAR).
For more information, please
contact:
Summit |
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Glyn
Edwards / Richard Pye (UK office) |
Tel: |
44
(0)1235 443 951 |
Erik
Ostrowski / Michelle Avery (US office) |
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+1
617 225 4455 |
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Cairn Financial Advisers LLP (Nominated
Adviser) |
Tel: |
+44
(0)20 7213 0880 |
Liam
Murray / Tony Rawlinson |
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N+1 Singer (Joint Broker) |
Tel: |
+44
(0)20 7496 3000 |
Aubrey Powell / Jen Boorer |
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Panmure Gordon (Joint Broker) |
Tel: |
+44
(0)20 7886 2500 |
Freddy Crossley, Corporate Finance |
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Tom
Salvesen, Corporate Broking |
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MacDougall Biomedical Communications (US) |
Tel: |
+1
781 235 3060 |
Karen
Sharma |
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ksharma@macbiocom.com |
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Consilium Strategic Communications (UK) |
Tel: |
+44
(0)20 3709 5700 |
Mary-Jane Elliott / Jessica Hodgson / |
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summit@consilium-comms.com |
Philippa Gardner |
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Forward Looking StatementsAny
statements in this press release about Summit’s future
expectations, plans and prospects, including but not limited to,
statements about the clinical and preclinical development of
Summit’s product candidates, the therapeutic potential of Summit’s
product candidates, the timing of initiation, completion and
availability of data from clinical trials, the potential submission
of applications for regulatory approvals, the sufficiency of
Summit’s cash resources, and other statements containing the words
“anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”
“intend,” “may,” “plan,” “potential,” “predict,” “project,”
“should,” “target,” “would,” and similar expressions, constitute
forward looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including: the
uncertainties inherent in the initiation of future clinical trials,
availability and timing of data from ongoing and future clinical
trials and the results of such trials, whether preliminary results
from a clinical trial will be predictive of the final results of
that trial or whether results of early clinical trials or
preclinical studies will be indicative of the results of later
clinical trials, expectations for regulatory approvals,
availability of funding sufficient for Summit’s foreseeable and
unforeseeable operating expenses and capital expenditure
requirements and other factors discussed in the “Risk Factors”
section of filings that Summit makes with the Securities and
Exchange Commission including Summit’s Annual Report on Form 20-F
for the fiscal year ended January 31, 2017. Accordingly,
readers should not place undue reliance on forward looking
statements or information. In addition, any forward-looking
statements included in this press release represent Summit’s views
only as of the date of this release and should not be relied upon
as representing Summit’s views as of any subsequent date. Summit
specifically disclaims any obligation to update any forward-looking
statements included in this press release.
CHAIRMAN’S STATEMENT
This past year has been marked by success and
progress across the business. Summit now has two clinical
programmes with positive clinical data in patients, external
validation for both our C. difficile infection (‘CDI’) and Duchenne
muscular dystrophy (‘DMD’) programmes, a strengthened pipeline for
a sustainable future and a strengthened team to guide the
development of novel drugs for serious illnesses.
Clinical SuccessWe delivered
the first clinical evidence of ezutromid activity in patients with
DMD. Ezutromid has the potential to profoundly improve the lives of
all patients living with DMD. The evidence we have seen after just
24 weeks of treatment indicates ezutromid is potentially reducing
the severity of the disease. To put the typical severity of the
disease in perspective, patients with DMD progressively lose muscle
function throughout their lives, ultimately resulting in premature
death in their late twenties. Changes to the inexorable disease
progression could provide meaningful benefit for patients. We
anticipate that the 48-week data has the potential to provide
continued evidence of improved disease progression through
measurements of muscle health, and we expect to report those data
in the third quarter of 2018.
The 24-week data have bolstered our confidence
that ezutromid could become the standard of care for all patients
with DMD. We are preparing ourselves to rapidly advance ezutromid
towards the market after receipt of the 48-week data. We see two
potential paths to get to market with positive 48-week data. In one
scenario, we could potentially pursue accelerated approval in the
US based on the 48-week data. In another scenario, we conduct a
pivotal, placebo controlled trial that would be the basis of
regulatory filings for approvals in the US and EU. Our recent
fundraise in Europe allows us to maintain clinical and regulatory
flexibility for both of these options. We remain committed to
independently commercialising ezutromid in the United States, one
the world’s most important pharmaceutical markets, while our
partner, Sarepta Therapeutics, has commercialisation rights in
Europe.
External ValidationOur
precision antibiotic for CDI garnered third-party US Government
support with a $62 million BARDA award. This is a major endorsement
for ridinilazole. These funds are helping to support the Phase 3
clinical and regulatory development of ridinilazole.
Ridinilazole’s potential to treat CDI and reduce
recurrent disease make it an attractive potential option for
front-line treatment. To support this positioning, we carefully
designed our Phase 3 programme to provide evidence of value for
patients, payors and healthcare providers. There is an urgent need
for new treatment options in CDI with over one million cases a year
in the US and Europe and we believe ridinilazole is the answer.
The external validation our CDI programme
received this year from BARDA complements the validation we
received of our DMD programme through our strategic partnership
with Sarepta. This partnership continues to provide us with
intangible benefits, such as access to Sarepta’s knowledge and
expertise in DMD drug development, as well as financial support.
This past year, we received a $22 million milestone payment from
Sarepta upon the completion of enrolment in our PhaseOut DMD
clinical trial, and as of January 2018, Sarepta is contributing a
45% share of our global DMD programme development costs.
A Sustainable Pipeline
Antibiotic resistance is an emerging global health and political
issue. We believe that our investments in antibiotic research and
development provide an opportunity for Summit to assume a
leadership role in this field. Our strategy is to develop new
mechanism antibiotics designed to treat specific diseases where we
can demonstrate clear advantages over existing standards of care
and have clear commercial value. We will pursue this strategy with
our recently acquired discovery and development platform.
Separately, we continue to secure our leadership
in utrophin modulation through our ongoing collaboration with the
University of Oxford. We intend to have the first- and
best-in-class molecules with the goal of one day being able to stop
DMD disease progression for all patients living with this
disorder.
A Bright FutureWe enter this
next year in a position of strength with great opportunities for
our products. Our progress brought us one step closer to realising
the significant value of ezutromid and ridinilazole for the
Company, shareholders and most importantly, patients. Our growth
over the past year ensures we have a strong team and a pipeline for
the future. We now look to an exciting year ahead with the full
results from PhaseOut DMD expected in the third quarter of this
year.
Having two clinical stage assets with compelling
patient data is a tremendous achievement and one that would not
have happened without the continued support from our shareholders
and dedication and professionalism from our employees. Finally, I’d
like to thank the patients, families and clinical sites involved in
our clinical trials. Without them, we would not be able to make
such progress in advancing our promising product candidates.
Frank Armstrong, FRCPE,
FFPMNon-Executive Chairman
OPERATIONAL REVIEW
Summit is a biopharmaceutical company focused on
the discovery, development and commercialisation of novel medicines
for indications in rare diseases and infectious diseases for which
there are no existing or only inadequate therapies. In rare
diseases, Summit is pioneering utrophin modulation as a potential
disease modifying treatment for all patients affected by the fatal
disorder DMD. In infectious diseases, Summit’s clinical focus is on
advancing the development of the precision antibiotic ridinilazole
that has the potential to not only treat the initial CDI infection,
but importantly to reduce rates of recurrent disease. In the
broader infectious disease area, Summit is developing new mechanism
antibiotics against pathogens where an urgent unmet need exists,
and where the Company can demonstrate advantages over current
treatments.
Rare Diseases: Duchenne Muscular
Dystrophy
Utrophin Modulation
Programme
DMD is the most common and severe form of
muscular dystrophy, impacting 50,000 patients in the developed
world alone. DMD is caused by the lack of dystrophin, a protein
that maintains healthy muscle function. The absence of dystrophin
results in a catastrophic cycle of muscle damage and repair that
leads to progressive loss of functional ability and ultimately in
premature death.
Utrophin and dystrophin play a similar role in
maintaining muscle function, but do so at different times. Utrophin
plays this role when new muscle fibres are being formed, or when
damaged fibres are being repaired, but then switches off to make
way for dystrophin to perform this role in mature muscle fibres.
Since patients with DMD are not able to produce dystrophin, a cycle
of muscle damage and repair occurs, which eventually leads to
muscle fibre failure. Utrophin modulation aims to address the root
cause of DMD by maintaining the production of utrophin to
substitute for the missing dystrophin. The presence of utrophin in
mature muscle fibres could break the cycle of damage and repair and
ultimately slow, or even stop, disease progression. Importantly,
this approach has the potential to treat all patients with DMD
regardless of their underlying dystrophin gene mutation.
Summit has established a leadership position in
the field of utrophin modulation with a pipeline of small molecule
utrophin modulator therapies. The Company’s lead utrophin
modulator, ezutromid, has shown evidence of reducing DMD disease
severity in patients in a Phase 2 clinical trial.
Ezutromid Clinical
Development
Ezutromid: PhaseOut DMD, a Phase 2 Proof of
Concept TrialPhaseOut DMD is a 48-week, open-label Phase 2 clinical
trial evaluating ezutromid in patients with DMD. The clinical trial
completed enrolment of 40 patients aged between their fifth and
tenth birthdays at multiple sites in the US and UK in May 2017. At
the end of 48 weeks of dosing, patients have the option of
continuing to be dosed with ezutromid in an extension phase.
Results from a planned 24-week interim analysis were announced in
January and February 2018. Top-line results from the full 48-week
trial are expected in the third quarter of 2018.
PhaseOut DMD aims to establish proof of concept
for ezutromid through the evaluation of muscle health and function.
Primary and secondary endpoints are focused on muscle health and
exploratory measures assess muscle function. With respect to muscle
health, PhaseOut DMD measures the change from baseline in magnetic
resonance parameters of the leg after 48 weeks of treatment as the
primary endpoint. Biopsy measures evaluating utrophin and muscle
damage are assessed as secondary muscle health endpoints. For
muscle function, PhaseOut DMD measures the North Star Ambulatory
Assessment and six-minute walk distance.
DMD progresses over many years, beginning with
instability of the muscle membrane that leads to a relentless cycle
of muscle damage and repair. The first anticipated evidence of drug
effect of ezutromid would therefore be related to utrophin protein
expression and reduced muscle fibre damage and inflammation.
Further downstream effects related to muscle health and function
are expected to be seen with longer dosing.
The PhaseOut DMD 24-week interim data show
ezutromid stabilised muscle fibre membranes as measured by a mean
increase in levels of utrophin protein. This led to a statistically
significant and meaningful decrease in muscle damage, as measured
by levels of the biomarker developmental myosin in muscle biopsies,
and a significant decrease in muscle inflammation as measured by
magnetic resonance spectroscopy.
The combination of these findings supports
ezutromid target engagement, and provides evidence of ezutromid’s
early impact on downstream muscle health. Importantly, ezutromid
was shown to be well tolerated.
Future Clinical and Regulatory Development Plans
The Company’s objective is to rapidly advance ezutromid’s
development. Summit will evaluate its clinical and regulatory
options after receipt of the PhaseOut DMD 48-week top-line data. To
maintain clinical and regulatory flexibility, the Company is
accelerating plans for a randomised, placebo-controlled clinical
trial for ezutromid alongside preparatory activities to support a
potential regulatory filing of ezutromid based on the 48-week
PhaseOut DMD clinical trial results if they are positive.
Pipeline Activities
As part of the Company’s strategy to maintain
its leadership position in the field of utrophin modulation, Summit
is developing a pipeline of future generation utrophin modulators.
This research, conducted as part of the strategic alliance with the
University of Oxford, is building on the promise of ezutromid to
identify new, structurally distinct molecules.
Sarepta Therapeutics Licence and
Collaboration Agreement
The clinical progress made with ezutromid
triggered a $22 million milestone payment from Sarepta as part of
the exclusive European licence and collaboration agreement that was
signed in October 2016. Starting 1 January 2018, Summit and Sarepta
share specified global research and development costs related to
Summit’s utrophin modulator pipeline at a 55%/45% split,
respectively.
Summit retains commercialisation rights in all
other countries, including the United States and Japan.
Other Activities
In September 2017, Summit joined the
Collaborative Trajectory Analysis Project (‘cTAP’) to support
cTAP’s mission of accelerating the development of drugs to treat
DMD through a coalition of Duchenne clinical experts, patient
advocates and biopharmaceutical companies. Summit believes cTAP’s
predictive models of disease progression could benefit the
development of its utrophin modulator pipeline.
Infectious Diseases
C. difficile InfectionCDI is a major healthcare
threat. There are over one million estimated cases of CDI
annually between the United States and Europe alone. Mainstay CDI
treatments are dominated by broad spectrum antibiotics that cause
substantial disruption to the collection of bacteria in the gut
flora, which leads to high rates of recurrent disease. Each
recurrent episode of CDI is typically more severe than the prior
episode, and carries an increased risk of mortality. As such,
disease recurrence is the key clinical issue facing CDI.
Ridinilazole is a novel class, precision
antibiotic designed to selectively target C. difficile bacteria
without causing collateral damage to the gut flora. Therefore, it
has the potential to be a front-line therapy that treats not only
the initial CDI infection, but importantly reduces the rate of CDI
recurrence. Ridinilazole has received Qualified Infectious Disease
Product designation and has been granted Fast Track designation in
the US.
Phase 2 Clinical ProgrammeSummit has generated a
comprehensive preclinical and clinical data package supporting
ridinilazole as a potential new front-line treatment for CDI. In a
Phase 2 proof of concept clinical trial called CoDIFy, ridinilazole
was shown to be highly preserving of the microbiome of patients
compared with the standard of care, vancomycin, and achieved a
substantial reduction in rates of recurrent disease. Ridinilazole
notably demonstrated statistical superiority over vancomycin in the
primary endpoint of the trial called sustained clinical response
(‘SCR’), an endpoint that combines cure at the end of treatment and
the number of recurrences in the subsequent 30-days. Results from
this 100-patient, double-blind clinical trial were published in The
Lancet Infectious Diseases in April 2017. Building on the CoDIFy
data, top-line data were reported from an exploratory Phase 2
clinical trial in September 2017 that showed ridinilazole preserved
the gut microbiomes of patients with CDI better than the marketed
narrow-spectrum antibiotic fidaxomicin.
Regulatory Update and Planned Phase 3 Clinical
ProgrammeIn February 2017, Summit outlined its Phase 3 development
programme for ridinilazole following input from the FDA and
European Medicines Agency. The Phase 3 programme aims to
differentiate this novel antibiotic from the current standard of
care treatment for CDI and help position the drug for commercial
success.
The two planned Phase 3 clinical trials are
expected to enrol approximately 700 patients each. The primary
endpoint is expected to be superiority in SCR, which was the
primary endpoint used in Summit’s Phase 2 proof of concept trial of
ridinilazole. Other planned endpoints will include health economic
outcome measures to support the commercial positioning of
ridinilazole as a front-line treatment for CDI. The Company expects
to initiate these clinical trials in the first quarter of 2019.
Funding and Licensing AgreementsIn September
2017, Summit was awarded a contract worth up to $62 million from
the US Biomedical Advanced Research and Development Authority
(‘BARDA’) to fund, in part, the clinical and regulatory development
of ridinilazole.
In December 2017, Summit entered into a licence
and commercialisation agreement to grant the Brazilian based
company Eurofarma Laboratórios (‘Eurofarma’) exclusive rights to
commercialise ridinilazole for CDI in certain countries in South
America, Central America and the Caribbean. Summit retains
commercial rights in the rest of the world including the United
States and Europe.
The Company believes these agreements are a
testament to the strength of ridinilazole’s clinical and
preclinical data.
Novel Antibiotic Discovery and Development
PlatformIn December 2017, Summit acquired an innovative bacterial
genetics-based platform to generate new mechanism antibiotics.
Summit intends to use the platform to develop compounds that target
pathogens where there is a serious unmet need and where the Company
can demonstrate advantages over the current standard of treatment.
This platform combines transposon technology with bioinformatics to
create a powerful tool to identify new antibacterial drug targets,
elucidate antibiotic mechanisms of action and optimise against
bacterial resistance.
In March 2018, the Company unveiled a series of
new mechanism antibiotics identified using this platform that
target gonorrhoea. In early testing, these compounds have been
shown to have high potency against strains of gonorrhoea with no
development of resistance to date. The Company expects to select a
candidate to advance into IND enabling studies in the second half
of 2018.
Operational Update
In January 2017, Dr David Roblin was appointed
as Chief Operating Officer (‘COO’) and President of Research &
Development and his role was expanded to include Chief Medical
Officer in May 2017. Dr Roblin has had a highly successful career
in the pharmaceutical industry, including senior leadership roles
at Pfizer and Bayer, which involved overseeing the research,
development and commercial launch of drugs across several therapy
areas including infectious diseases. His depth of knowledge and
expertise will help to ensure Summit is at the forefront of
utrophin modulation in DMD and innovative antibiotic
development.
FINANCIAL REVIEW
Revenue
Revenue increased by £23.1 million to £25.4
million for the year ended 31 January 2018 from £2.3 million for
the year ended 31 January 2017. The increase was due to income
recognised following the exclusive licence and collaboration
agreement entered into with Sarepta in October 2016. During the
year ended 31 January 2018, £6.9 million relating to the upfront
payment of $40.0 million (£32.8 million) received from Sarepta in
October 2016 was recognised compared to £2.3 million for the year
ended 31 January 2017. To date, an aggregate of £9.2 million of the
upfront payment has been recognised while the remaining £23.6
million is classified as deferred revenue and will continue to be
recognised as revenue over the development period. Revenue
recognised during the year ended 31 January 2018 also reflects the
receipt of a development milestone of £17.2 million ($22.0 million)
paid by Sarepta which was recognised in full and £0.9 million of
revenue in respect of specified research and development costs
funded by Sarepta. The Group also recognised £0.1 million of
revenue following receipt of a $2.5 million upfront payment in
respect of the licence and commercialisation agreement signed with
Eurofarma in December 2017, and £0.3 million of revenue pursuant to
a research collaboration agreement between the Group’s acquired
subsidiary Discuva Limited and F. Hoffmann - La Roche Limited.
Other Operating Income
Other operating income increased by
£2.6 million to £2.7 million during the year ended 31
January 2018 from £0.1 million during the year ended 31
January 2017. This increase resulted primarily from the recognition
of £1.8 million pursuant to Summit’s funding contract with BARDA
that was awarded to the Group in September 2017 and £0.9 million
resulting from the derecognition of a part of Summit’s financial
liabilities on funding arrangements.
Operating Expenses
Research and Development ExpensesResearch and
development expenses increased by £10.0 million, or 52.9 %, to
£29.0 million for the year ended 31 January 2018 from £19.0 million
for the year ended 31 January 2017. This was due to increased
spending related to both the DMD and CDI programmes. Investment in
the DMD programme increased by £6.5 million to £16.0 million from
£9.5 million for the year ended 31 January 2017. Costs associated
with the CDI programme increased by £1.5 million to £5.6 million
for the year ended 31 January 2018 from £4.1 million for the year
ended 31 January 2017. Other research and development expenses
increased by £2.0 million during the period which was primarily
attributable to an increase in headcount within the DMD and CDI
project teams.
General and Administration ExpensesGeneral and
administration expenses increased by £3.7 million, or 45.0 %, to
£12.0 million for the year ended 31 January 2018 from £8.3 million
for the year ended 31 January 2017. This increase was due to a net
negative movement in exchange rate variances of £1.5 million, an
increase of £1.3 million in staff related costs, an increase of
£0.6 million in overhead and facility related costs and an increase
of £0.3 million in share-based payment expense.
Finance Income
Finance income was £3.1 million for the year
ended 31 January 2018 and related primarily to the de-recognition
of part of the Group’s financial liabilities on funding
arrangements, specifically the remeasurements and discounts
associated with those liabilities since initial recognition.
Finance income recognised in comparative periods relates to
interest
received.
Finance Costs
Finance costs increased by £0.3 million, or
35.0%, to £1.2 million for the year ended 31 January 2018 from £0.9
million for the year ended 31 January 2017 and related to the
unwinding of the discount and remeasurements on financial
liabilities on funding arrangements.
Taxation
Our income tax credit decreased by £0.5 million,
or 13.2%, to £3.8 million for the year ended 31 January 2018 from
£4.3 million for the year ended 31 January 2017. This was driven by
our lower level of net loss during the year ended 31 January 2018
as compared to the year ended 31 January 2017, which impacts the
level of income tax credit receivable.
Losses
Loss before income tax was £10.9 million for the
year ended 31 January 2018 compared to £25.7 million for the year
ended 31 January 2017. Net loss for the year ended 31 January 2018
was £7.1 million with a net loss per share of 11 pence compared to
a net loss of £21.4 million for the year ended 31 January 2017 and
a net loss per share of 35 pence.
Cash Flows
The Group had a net cash outflow of £6.0 million
for the year ended 31 January 2018 as compared to a net cash inflow
of £12.5 million for the previous year.
For the year ended 31 January 2018 net cash used
by operating activities was of £14.7 million as compared to net
cash generated from operating activities of £12.1 million for the
year ended 31 January 2017. This net movement of £26.8 million was
driven by an increase in research and development costs during the
year ended 31 January 2018, and the receipt, during the year ended
31 January 2017, of a £32.8 million upfront payment as part of the
Sarepta agreement entered into in October 2016 which was partially
offset by the receipt of the development milestone from Sarepta of
£17.2 million during the year ended 31 January 2018, as well as the
funding received from BARDA and the upfront payment received from
Eurofarma during the year ended 31 January 2018.
Net cash outflows from investing activities for
the year ended 31 January 2018 of £5.2 million includes £4.8
million used in the acquisition of Discuva Limited in December
2017, net of cash acquired as part of the transaction, and a
further £0.5 million used to acquire property, plant and equipment
and intangible assets mainly in relation to the relocation of
Summit’s UK office in Oxford.
Net cash generated from financing activities for
the year ended 31 January 2018 of £13.9 million includes £13.5
million of proceeds, net of transaction costs, received following
the Company’s underwritten public equity offering in September 2017
and £0.4 million received following the exercise of warrants and
share options. During the year ended 31 January 2017 the Group
received proceeds of £0.4 million following the exercise of
warrants and share options.
Financial position
As at 31 January 2018, total cash and cash
equivalents held were £20.1 million (31 January 2017: £28.1
million).
In March 2018, post the period under review,
total gross proceeds of £15.0 million ($21.2 million) were raised
through a placing of new ordinary shares.
Headcount
Average headcount of the Group for the year was
60 (2017: 44).
Share Capital
In September 2017, the Group completed an
underwritten public offering on the NASDAQ Global Market issuing
1,677,850 American Depositary Shares (‘ADS’) at a price of $12.00
per ADS. Each ADS represents five ordinary shares of one penny
nominal value each in the capital of the Company, meaning 8,389,250
new ordinary shares were issued. Total gross proceeds of $20.1
million (£14.9 million) were raised and directly attributable
transaction costs of £1.4 million were incurred.
In December 2017, the Group acquired 100% of the
share capital of Discuva Limited. As part of the consideration the
Group issued £5.0 million in new ordinary shares to the former
Discuva shareholders at a price of 170.4 pence per share, meaning
2,934,272 ordinary shares were issued.
In February 2017, warrants over 50,000 ordinary
shares were exercised raising net proceeds of £0.01 million.
During the year 348,536 share options were
exercised raising net proceeds of £0.39 million.
Glyn Edwards
Erik Ostrowski Chief Executive Officer Chief Financial Officer
11 April 2018
FINANCIAL STATEMENTS
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
(audited) For the year ended 31 January 2018
|
|
Twelvemonths ended 31 January 2018 |
|
Twelve months ended 31 January
2018 |
|
Twelve
months ended 31 January 2017 |
|
|
Note |
$000s |
|
£000s |
|
£000s |
|
|
|
|
|
|
Revenue |
|
36,070 |
|
25,419 |
|
2,304 |
|
|
|
|
|
|
Other operating
income |
|
3,867 |
|
2,725 |
|
72 |
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
Research and
development |
|
(41,108 |
) |
(28,970 |
) |
(18,952 |
) |
General and administration |
|
(17,027 |
) |
(11,999 |
) |
(8,277 |
) |
Total operating
expenses |
|
(58,135 |
) |
(40,969 |
) |
(27,229 |
) |
|
|
|
|
|
Operating
loss |
|
(18,198 |
) |
(12,825 |
) |
(24,853 |
) |
|
|
|
|
|
Finance
income |
|
4,393 |
|
3,096 |
|
8 |
|
Finance
cost |
|
(1,652 |
) |
(1,164 |
) |
(862 |
) |
|
|
|
|
|
Loss before
income tax |
|
(15,457 |
) |
(10,893 |
) |
(25,707 |
) |
|
|
|
|
|
Income
tax |
|
5,338 |
|
3,762 |
|
4,336 |
|
|
|
|
|
|
Loss for the year |
|
(10,119 |
) |
(7,131 |
) |
(21,371 |
) |
|
|
|
|
|
Other
comprehensive (losses) / income |
|
|
|
|
Items that may be
reclassified subsequently to profit or loss |
|
|
|
|
Exchange
differences on translating foreign operations |
|
(18 |
) |
(13 |
) |
29 |
|
Total comprehensive loss for the year |
|
(10,137 |
) |
(7,144 |
) |
(21,342 |
) |
Basic and diluted loss per ordinary share from
operations |
2 |
(15)cents |
(11)pence |
(35)pence |
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
(unaudited) For the three months ended 31 January 2018
|
|
Threemonths ended 31 January2018 |
|
Threemonths ended 31 January2018 |
|
Threemonths ended 31 January2017 |
|
|
Note |
$000s |
|
£000s |
|
£000s |
|
|
|
|
|
|
Revenue |
|
4,274 |
|
3,012 |
|
1,728 |
|
|
|
|
|
|
Other operating
income |
|
1,633 |
|
1,151 |
|
- |
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
Research and
development |
|
(14,051 |
) |
(9,902 |
) |
(4,792 |
) |
General and administration |
|
(7,231 |
) |
(5,096 |
) |
(3,027 |
) |
Total operating
expenses |
|
(21,282 |
) |
(14,998 |
) |
(7,819 |
) |
|
|
|
|
|
Operating
loss |
|
(15,375 |
) |
(10,835 |
) |
(6,091 |
) |
|
|
|
|
|
Finance
income |
|
13 |
|
9 |
|
1 |
|
Finance
cost |
|
(702 |
) |
(495 |
) |
(215 |
) |
|
|
|
|
|
Loss before
income tax |
|
(16,064 |
) |
(11,321 |
) |
(6,305 |
) |
|
|
|
|
|
Income
tax |
|
(280 |
) |
(197 |
) |
1,380 |
|
|
|
|
|
|
Loss for the period |
|
(16,344 |
) |
(11,518 |
) |
(4,925 |
) |
|
|
|
|
|
Other
comprehensive losses |
|
|
|
|
Items that may be
reclassified subsequently to profit or loss |
|
|
|
|
Exchange
differences on translating foreign operations |
|
(11 |
) |
(8 |
) |
(14 |
) |
Total comprehensive loss for the period |
|
(16,355 |
) |
(11,526 |
) |
(4,939 |
) |
Basic and diluted loss per ordinary share from
operations |
2 |
(23)cents |
(16)pence |
(8)pence |
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
(audited)As at 31 January 2018
|
|
31 January2018 |
|
31 January2018 |
|
31
January2017 |
|
|
|
$000s |
|
£000s |
|
£000s |
|
ASSETS |
|
|
|
|
Non-current
assets |
|
|
|
|
Goodwill |
|
3,516 |
|
2,478 |
|
664 |
|
Intangible assets |
|
20,980 |
|
14,785 |
|
3,470 |
|
Property,
plant and equipment |
|
1,148 |
|
809 |
|
116 |
|
|
|
25,644 |
|
18,072 |
|
4,250 |
|
Current
assets |
|
|
|
|
Prepayments and other
receivables |
|
15,799 |
|
11,134 |
|
1,027 |
|
Current tax
receivable |
|
6,605 |
|
4,654 |
|
4,248 |
|
Cash and
cash equivalents |
|
28,525 |
|
20,102 |
|
28,062 |
|
|
|
50,929 |
|
35,890 |
|
33,337 |
|
|
|
|
|
|
Total assets |
|
76,573 |
|
53,962 |
|
37,587 |
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
Non-current
liabilities |
|
|
|
|
Deferred revenue |
|
(25,589 |
) |
(18,033 |
) |
(23,615 |
) |
Financial liabilities
on funding arrangements |
|
(4,385 |
) |
(3,090 |
) |
(5,919 |
) |
Provisions for other
liabilities and charges |
|
(2,329 |
) |
(1,641 |
) |
(85 |
) |
Deferred tax
liability |
|
(3,376 |
) |
(2,379 |
) |
(565 |
) |
|
|
(35,679 |
) |
(25,143 |
) |
(30,184 |
) |
Current
liabilities |
|
|
|
|
Trade and other
payables |
|
(12,675 |
) |
(8,932 |
) |
(3,984 |
) |
Deferred revenue |
|
(14,207 |
) |
(10,012 |
) |
(6,912 |
) |
|
|
(26,882 |
) |
(18,944 |
) |
(10,896 |
) |
|
|
|
|
|
Total liabilities |
|
(62,561 |
) |
(44,087 |
) |
(41,080 |
) |
|
|
|
|
|
Net assets / (liabilities) |
|
14,012 |
|
9,875 |
|
(3,493 |
) |
|
|
|
|
|
EQUITY |
|
|
|
|
Share capital |
|
1,044 |
|
736 |
|
618 |
|
Share premium
account |
|
85,476 |
|
60,237 |
|
46,420 |
|
Share-based payment
reserve |
|
9,568 |
|
6,743 |
|
5,136 |
|
Merger reserve |
|
4,295 |
|
3,027 |
|
(1,943 |
) |
Special reserve |
|
28,370 |
|
19,993 |
|
19,993 |
|
Currency translation
reserve |
|
53 |
|
37 |
|
50 |
|
Accumulated losses reserve |
|
(114,794 |
) |
(80,898 |
) |
(73,767 |
) |
Total equity /
(deficit) |
|
14,012 |
|
9,875 |
|
(3,493 |
) |
CONSOLIDATED STATEMENT OF CASH FLOWS (audited)
For the year ended 31 January 2018
|
Twelvemonthsended31
January2018 |
|
Twelvemonthsended31
January2018 |
|
Twelvemonthsended31 January2017 |
|
|
$000s |
|
£000s |
|
£000s |
|
Cash flows from
operating activities |
|
|
|
Loss before income
tax |
(15,457 |
) |
(10,893 |
) |
(25,707 |
) |
|
|
|
|
Adjusted for: |
|
|
|
Other operating income
on derecognition of financial liabilities on funding
arrangements |
(1,288 |
) |
(908 |
) |
- |
|
Finance income |
(4,393 |
) |
(3,096 |
) |
(8 |
) |
Finance cost |
1,652 |
|
1,164 |
|
862 |
|
Foreign exchange
loss |
2,781 |
|
1,960 |
|
711 |
|
Depreciation |
199 |
|
140 |
|
48 |
|
Amortisation of
intangible fixed assets |
150 |
|
106 |
|
10 |
|
Loss on disposal of
assets |
57 |
|
40 |
|
- |
|
Movement in
provisions |
(85 |
) |
(60 |
) |
12 |
|
Research and
development expenditure credit |
(33 |
) |
(23 |
) |
(3 |
) |
Share-based payment |
2,280 |
|
1,607 |
|
1,379 |
|
Adjusted loss from
operations before changes in working capital |
(14,137 |
) |
(9,963 |
) |
(22,696 |
) |
|
|
|
|
(Increase) / decrease
in prepayments and other receivables |
(12,761 |
) |
(8,993 |
) |
492 |
|
(Decrease) / increase
in deferred revenue |
(3,522 |
) |
(2,482 |
) |
30,527 |
|
Increase
in trade and other payables |
4,789 |
|
3,375 |
|
813 |
|
Cash (used by) /
generated from operations |
(25,631 |
) |
(18,063 |
) |
9,136 |
|
Taxation
received |
4,788 |
|
3,374 |
|
3,005 |
|
Net cash (used by) / generated from operating
activities |
(20,843 |
) |
(14,689 |
) |
12,141 |
|
|
|
|
|
Investing
activities |
|
|
|
Acquisition of
subsidiaries net of cash acquired |
(6,776 |
) |
(4,775 |
) |
- |
|
Purchase of property,
plant and equipment |
(511 |
) |
(360 |
) |
(81 |
) |
Purchase of intangible
assets |
(169 |
) |
(119 |
) |
(7 |
) |
Interest
received |
17 |
|
12 |
|
8 |
|
Net cash used in investing activities |
(7,439 |
) |
(5,242 |
) |
(80 |
) |
|
|
|
|
Financing
activities |
|
|
|
Proceeds from issue of
share capital |
21,187 |
|
14,931 |
|
- |
|
Transaction costs on
share capital issued |
(2,026 |
) |
(1,428 |
) |
- |
|
Proceeds from exercise
of warrants |
14 |
|
10 |
|
107 |
|
Proceeds from exercise
of share options |
556 |
|
392 |
|
283 |
|
Cash received from
funding arrangements accounted for as financial liabilities |
- |
|
- |
|
23 |
|
Net cash generated from financing activities |
19,731 |
|
13,905 |
|
413 |
|
|
|
|
|
(Decrease) /
Increase in cash and cash equivalents |
(8,551 |
) |
(6,026 |
) |
12,474 |
|
|
|
|
|
Effect of
exchange rates on cash and cash equivalents |
(2,744 |
) |
(1,934 |
) |
(716 |
) |
|
|
|
|
Cash and cash
equivalents at beginning of the year |
39,820 |
|
28,062 |
|
16,304 |
|
|
|
|
|
Cash and cash equivalents at end of the year |
28,525 |
|
20,102 |
|
28,062 |
|
CONSOLIDATED STATEMENT OF CHANGES IN
EQUITY (audited)
Year ended 31 January 2018
Group |
|
Sharecapital£000s |
Sharepremiumaccount£000s |
|
Share-basedpaymentreserve£000s |
Mergerreserve£000s |
|
Specialreserve£000s |
Currencytranslationreserve£000s |
|
Accumulatedlossesreserve£000s |
|
Total £000s |
|
At 1
February 2017 |
|
618 |
46,420 |
|
5,136 |
(1,943 |
) |
19,993 |
50 |
|
(73,767 |
) |
(3,493 |
) |
Loss
for the year |
|
- |
- |
|
- |
- |
|
- |
- |
|
(7,131 |
) |
(7,131 |
) |
Currency translation adjustment |
|
- |
- |
|
- |
- |
|
- |
(13 |
) |
- |
|
(13 |
) |
Total
comprehensive loss for the year |
|
- |
- |
|
- |
- |
|
- |
(13 |
) |
(7,131 |
) |
(7,144 |
) |
New
share capital issued |
|
84 |
14,847 |
|
- |
- |
|
- |
- |
|
- |
|
14,931 |
|
Transaction costs on share capital issued |
|
- |
(1,428 |
) |
- |
- |
|
- |
- |
|
- |
|
(1,428 |
) |
Issue
of ordinary shares as consideration for a business combination |
|
30 |
- |
|
- |
4,970 |
|
- |
- |
|
- |
|
5,000 |
|
New
share capital issued from exercise of warrants |
|
1 |
9 |
|
- |
- |
|
- |
- |
|
- |
|
10 |
|
Share
options exercised |
|
3 |
389 |
|
- |
- |
|
- |
- |
|
- |
|
392 |
|
Share-based payment |
|
- |
- |
|
1,607 |
- |
|
- |
- |
|
- |
|
1,607 |
|
At 31 January 2018 |
|
736 |
60,237 |
|
6,743 |
3,027 |
|
19,993 |
37 |
|
(80,898 |
) |
9,875 |
|
Year ended 31 January 2017
Group |
|
Share capital£000s |
Sharepremiumaccount£000s |
Share-basedpaymentreserve£000s |
Mergerreserve£000s |
|
Specialreserve£000s |
Currencytranslationreserve£000s |
Accumulatedlossesreserve£000s |
|
Total £000s |
|
At 1 February 2016 |
|
613 |
46,035 |
3,757 |
(1,943 |
) |
19,993 |
21 |
(52,396 |
) |
16,080 |
|
Loss for the year |
|
- |
- |
- |
- |
|
- |
- |
(21,371 |
) |
(21,371 |
) |
Currency
translation adjustment |
|
- |
- |
- |
- |
|
- |
29 |
- |
|
29 |
|
Total comprehensive
loss for the year |
|
- |
- |
- |
- |
|
- |
29 |
(21,371 |
) |
(21,342 |
) |
New share capital
issued from exercise of warrants |
|
2 |
105 |
- |
- |
|
- |
- |
- |
|
107 |
|
Share options
exercised |
|
3 |
280 |
- |
- |
|
- |
- |
- |
|
283 |
|
Share-based payment |
|
- |
- |
1,379 |
- |
|
- |
- |
- |
|
1,379 |
|
At 31
January 2017 |
|
618 |
46,420 |
5,136 |
(1,943 |
) |
19,993 |
50 |
(73,767 |
) |
(3,493 |
) |
NOTES TO THE FINANCIAL STATEMENTSFor the year
ended 31 January 2018
1. Basis of Accounting
This financial information for the years ended
31 January 2018 and 31 January 2017 does not constitute the
statutory financial statements for the respective years within the
meaning of Sections 434-436 of the Companies Act 2006 and is an
extract from the financial statements. It is based on, and is
consistent with, the Group’s statutory accounts for the year ended
31 January 2018 and those financial statements will be delivered to
the Registrar of Companies following the Company’s 2018 Annual
General Meeting. Financial statements for the year ended 31
January 2017 have been delivered to the Registrar of Companies. The
financial statements for the years ended 31 January 2018 and 2017
contain an unqualified report from the Group’s auditors.
The consolidated financial statements have been prepared in
accordance with International Financial Reporting Standards and
IFRS Interpretations Committee interpretations ('IFRS') as adopted
by the European Union and the Companies Act 2006 applicable to
companies reporting under IFRS. The Consolidated Financial
Statements have been prepared on a going concern basis and under
the historical cost convention.
Whilst the financial information included in
this preliminary announcement has been prepared in accordance with
IFRSs adopted for use in the European Union and as issued by the
International Accounting Standards Board, this announcement does
not itself contain sufficient information to comply with IFRSs.
This announcement is available from the Company
Secretary and is on the Company’s website.
The financial information for the three-month
periods ended 31 January 2018 and 2017 is unaudited.
Solely for the convenience of the reader, unless
otherwise indicated, all pound sterling amounts stated in the
Consolidated Statement of Financial Position as at 31 January 2018
and in the Consolidated Statement of Comprehensive Income and
Consolidated Statement of Cash Flows for the year and three months
ended 31 January 2018 have been translated into US dollars at the
rate on 31 January 2018 of $1.4190 to £1.00. These translations
should not be considered representations that any such amounts have
been, could have been or could be converted into US dollars at that
or any other exchange rate as at that or any other date.
The Board of Directors of the Company approved
this statement on 11 April 2018.
Adoption of IFRS 15 Revenue from
contracts with customers
IFRS 15 establishes comprehensive guidelines for determining
when to recognise revenue and how much revenue to recognise. The
core principle in that framework is that a company should recognise
revenue to depict the transfer of control of promised goods or
services to the customer in an amount that reflects the
consideration to which the company expects to be entitled in
exchange for those goods or services. The standard is
effective for reporting periods beginning on or after 1 January
2018 and replaces the accounting standard IAS 18 Revenue. The Group
will adopt this new standard effective 1 February 2018 as
required.
The Group has assessed the effect of adoption of this standard
as it relates to the licence and collaboration agreement with
Sarepta Therapeutics Inc. (‘Sarepta’), licence and
commercialisation agreement with Eurofarma Laboratórios SA
('Eurofarma') and the research collaboration agreement with F.
Hoffmann - La Roche Limited ('Roche'). Currently, the Group
anticipates the accounting for contingent milestone payments and
development cost share income to be the most significant change in
the accounting for its license and collaboration agreements. The
impact of the Group’s assessment would result in the contingent
milestone payments and development cost share income being
recognised over the estimated development services period, with
initial recognition when it becomes highly probable that a
significant reversal in the amount of cumulative revenue recognised
will not occur.
2. Loss per Share
Calculation
The loss per share has been calculated using the
loss for the period and dividing this by the weighted average
number of ordinary shares in issue during the twelve months ended
31 January 2018: 65,434,294 and during the three months ended 31
January 2018: 71,886,897 (for the twelve months ended 31 January
2017: 61,548,557 and for the three months ended 31 January 2017:
61,819,596).
Since the Group has reported a net loss, diluted
loss per share is equal to basic loss per share.
3. Issue of Share Capital
On 22 February 2017, warrants over 50,000 ordinary shares were
exercised at a price of 20 pence per share. The issue of
shares raised net proceeds of £10,000.
On 18 September 2017, the Group completed an underwritten public
offering on the Nasdaq Global Market issuing 1,459,000 American
Depositary Shares (‘ADS’) at a price of $12.00 per ADS. The
underwriters also exercised in full their over-allotment option to
purchase an additional 218,850 ADSs on the same terms which was
also completed on 18 September 2017. Each ADS represents five
ordinary shares of one penny nominal value each in the capital of
the Company, meaning 8,389,250 new ordinary shares were issued.
Total gross proceeds of $20.1 million (£14.9 million) were raised
and directly attributable transaction costs of £1.4 million were
incurred.
On 23 December 2017, the Group acquired 100% of the share
capital of Discuva Limited, a privately held UK-based company. As
part of the consideration the Group issued £5.0 million in new
ordinary shares of Summit of one penny nominal value to Discuva
shareholders at a price of 170.4 pence per share, meaning 2,934,272
ordinary shares were issued.
During the year to 31 January 2018 the following exercises of
share options took place:
Date |
Number of options exercised |
10 April 2017 |
16,667 |
27 June 2017 |
19,425 |
28 September 2017 |
32,500 |
29 September 2017 |
94,425 |
2 October 2017 |
97,199 |
4 October
2017 |
88,320 |
|
348,536 |
The total net proceeds from exercised share
options during the year was £0.39 million.
All new ordinary shares rank pari passu with
existing ordinary shares.
Following the public offering and exercise of
the over-allotment option, the issuance of shares as consideration
for the acquisition of Discuva Limited and the exercise of the
above share options and warrants, the number of ordinary shares in
issue was 73,563,624 at the end of 31 January 2018.
4. Business Combinations
On 23 December 2017, the Group acquired 100% of the share
capital of Discuva Limited ('Discuva'), a privately held UK-based
company. As part of the acquisition the Group has obtained a
bacterial genetics-based platform for the discovery and development
of new mechanism antibiotic compounds.
Under the terms of the acquisition, the consideration to Discuva
shareholders comprised of £6.1 million in cash (being £5.0 million
plus the value of net cash acquired by the Group as part of the
acquisition) and £5.0 million in new ordinary shares of Summit of
one penny nominal value issued to Discuva shareholders at a price
of 170.4 pence per share, representing 2,934,272 ordinary
shares.
5. Subsequent Event
Post year end on 29 March 2018, the Group completed a placing on
the AIM market of the London Stock Exchange, issuing 8,333,333 new
ordinary shares at a price of 180 pence per share. Total gross
proceeds of £15.0 million were raised (before expenses).
Following the placing the number of ordinary shares in issue was
81,901,173.
-END-
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Summit Therapeutics (NASDAQ:SMMT)
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From Jul 2023 to Jul 2024