TIDMOKYO
RNS Number : 2620H
OKYO Pharma Limited
02 August 2021
Final audited results for the year ended 31 March 2021
OKYO Pharma Limited (the "Company") is pleased to announce its
final audited results for the year ended 31 March 2021.
Summary of OKYO-101 studies during the last year
-- OK-101 is designed to target a chemokine-like receptor 1, or
CMKLR1, which is a G protein-coupled receptor, or GPCR, expressed
on macrophages, monocytes, plasmacytoid/myeloid dendritic cells,
natural killer cells and nonhemopoietic cell types, such as
endothelial and epithelial cells. Activation of CMKLR1 by its
endogenous peptide ligand chemerin is known to modulate
inflammation, but natural ligands for CMKLR1 have short half-lives
due to rapid inactivation.
-- To characterize the potential efficacy of OK-101 to treat
DED, OK-101 was tested in a mouse model of acute dry eye disease
induced with scopolamine that showed an increase in corneal
permeability relative to naïve animals. OK-101 demonstrated a
reduction of DED-induced corneal permeability (p <= 0.001).
-- OK-101's effect in reducing DED-induced corneal permeability
was virtually identical to that of the cyclosporine positive
control and close to the baseline corneal permeability observed in
control animals.
-- A separate series of experiments was also performed to
evaluate ocular tolerance of OK-101 in rabbits via repeated ocular
instillation followed by clinical ophthalmic observations. Rabbit
ocular tolerance tests on OK-101 showed no adverse signs such as
inflammation, chemosis or hyperemia and no signs of local
irritation.
-- We completed manufacturing a 25-gram batch of OK-101 drug
substance needed for initiating the IND-enabling studies.
-- We submitted a patent application to the United States Patent
and Trademark Office covering the use of chemerin and chemerin
analogues to treat the cytokine release syndrome associated with
COVID-19 infections and other conditions such as acute respiratory
distress syndrome (ARDS).
Summary of OKYO-201 studies during the last year
-- OK-201 is designed to activate a human MAS-Related G
Protein-coupled Receptor (MRGPR), which is a promising analgesic
target. This receptor is expressed mainly in sensory neurons and is
involved in the perception of pain. Activation of MRGPR by BAM
peptide inhibits pain by modulating Ca2+ influx.
-- On August 6, 2019 we signed a collaborative agreement with
TMC and Pedram Hamrah, MD, Professor of Ophthalmology at Tufts
University School of Medicine, Boston, MA as Principal Investigator
to evaluate our proprietary lead compounds as non-opioid analgesics
to suppress corneal neuropathic pain using a mouse ocular pain
model developed in Dr. Hamrah's laboratory.
-- We have synthesized a small library of lipidated BAM
analogues. The potencies of these analogues were determined using a
cell-based assay, and a small number of these analogues were
evaluated for their analgesic properties in the neuropathic pain
model developed by Dr. Hamrah's laboratory at TMC.
Future strategy of OKYO-101
Based on the results from the DED animal model and ocular
tolerance studies, we are presently moving forward with plans to
file an IND in the third quarter of 2022 on OK-101 to treat DED. To
support this work a
CRO specializing in ophthalmic drug development who will be
providing the following services:
-- Preparation of the OK-101 Pre-IND briefing document
-- Support in requesting and preparing for the OK-101 Pre-IND meeting with FDA
-- Support for regulatory publishing and submission of IND in eCTD format
-- Providing quality oversight for development of topical formulation for OK-101
-- Providing quality oversight for development and qualification
of a drug stability analysis method for OK-101 along with
conducting stability studies to establish formulated drug product
is stable for at least 90 days
-- Support for completing animal toxicology studies in two animal species
Future strategy of OKYO-201
During the next year, we will be continuing to conduct
preclinical studies and additional animal studies to further
evaluate the OK-201 preclinical candidate to treat corneal
neuropathic pain.
Financial Highlights
-- Total comprehensive loss of GBP2,994k ( 2020 : GBP1,211k )
-- Cash balance at 31 March 2020 of GBP4,991k (31 March 2020: GBP190k)
Enquiries:
+44 (0)20 7382
OKYO Pharma Limited Willy Simon 8300
Optiva Securities Limited +44 (0)20 3981
(Broker) Robert Emmet 4173
For further information, please visit the Company's website at
http://okyopharma.com/ .
Extracts from the annual accounts for the year ended 31 March
2021 are set out below
OKYO Pharma Limited
Strategic report
The Directors present their report and the financial statements
for the Company, OKYO Pharma Limited ("OKYO" or the "Company") and
its subsidiary, (together the "Group") for the year ended 31 March
2021.
Introduction
OKYO Pharma Limited (LSE: OKYO) is a preclinical
biopharmaceutical company developing next-generation therapeutics
to improve the lives of patients suffering from inflammatory eye
diseases and ocular pain. Our research program is focused on a
novel G protein coupled receptor (GPCR) which we believe plays a
key role in the pathology of the inflammatory eye diseases that are
the target of this technology. Previously we had focused on OK-113,
an agonist for chemokine-like receptor 1, or CMKLR1 receptor, as a
potential lead compound for the treatment of dry eye. However,
following further analyses of additional analogues tested in a
highly regarded animal model of dry eye disease (DED), we have
determined that OK-101 gave the highest potency and best results in
a number of biomarkers evaluated in the DED animal model studies.
Consequently, we have nominated OK-101 as our Investigational New
Drug ("IND") candidate and have initiated the IND-enabling studies
necessary for filing an IND. In addition to developing OK-101 for
the treatment of dry-eye, we also plan during the course of its
clinical development to evaluate OK-101 to treat two additional
related ophthalmic diseases: 1) uveitis and 2) allergic
conjunctivitis.
In a separate series of studies focused on developing a drug
from our technology to treat neuropathic ocular pain, we have also
been evaluating OK-201, a lipidated bovine adrenal medulla (BAM)
peptide analogue preclinical candidate for the treatment of this
condition. We are continuing these studies using a unique corneal
neuropathic pain animal model developed by our consultants at Tufts
Medical Center (TMC). Our therapeutic approach in all of these
studies has been focused on targeting inflammatory and pain
modulation pathways that drive these conditions.
We have not yet submitted an application to the Food and Drug
Administration ("FDA") for any of our product candidates. We have
however begun work on accomplishing all the studies necessary for
an IND submission for OK-101 to treat dry eye and are planning to
file an IND on OK-101 to treat dry eye in the third quarter of
2022.
OKYO R&D PROGRAMMES
1) OK-101 for Dry Eye Disease (DED)
OK-101, our lead preclinical product candidate, is focused on
keratoconjunctivitis sicca, commonly referred to as DED which is a
multifactorial disease caused by an underlying inflammation
resulting in the lack of lubrication and moisture in the surface of
the eye. DED is one of the most common ophthalmic conditions
encountered in clinical practice. Symptoms of DED include constant
discomfort and irritation accompanied by inflammation of the ocular
surface, visual impairment and potential damage to the ocular
surface. The disease affects over 35% of the population aged 50+,
with women representing approximately two-thirds of those affected.
Prevalence of DED is anticipated to increase substantially in the
next 10-20 years due to aging populations in the U.S., Europe,
Japan and China and use of contact lenses and increased digital
screen time in the younger population. We believe this increase in
prevalence of dry eye syndrome represents a major expanding
economic burden to public healthcare.
At present, there are three different categories of approved
drugs to treat DED: 1) Immunosuppressants (Restasis & Sequa),
2) Integrin antagonists (Xiidra) and 3) corticosteroids (e.g.,
Eysuvis for short term use only). However, DED continues to be a
major unmet medical need due to the large number of patients not
well served by the treatments available to them through the medical
community. A key driver in the development of OK-101 to treat DED
was an analysis of the inherent advantages and difficulties
associated with the treatment of ocular conditions. One of the
major issues with topical administration of any drug designed for
treating DED is the requirement that the drug have adequate
'residence' time at the ocular site to afford a pharmacologic
benefit before being washed out through natural processes of tear
enhancement and lacrimal tear drainage. The drug candidates we have
developed are designed to combat washout by including a lipid
'anchor' within the candidate drug molecule to enhance the
residence time of the drug in the eye. We refer to our candidates
for DED as "lipidated-chemerin" analogues to highlight this
pharmacologic characteristic.
OK-101 is designed to target a chemokine-like receptor 1, or
CMKLR1, which is a G protein-coupled receptor, or GPCR, expressed
on macrophages, monocytes, plasmacytoid/myeloid dendritic cells,
natural killer cells and nonhemopoietic cell types, such as
endothelial and epithelial cells. Activation of CMKLR1 by its
endogenous peptide ligand chemerin is known to modulate
inflammation, but natural ligands for CMKLR1 have short half-lives
due to rapid inactivation. Discovery of OK-101, a stable, high
potency CMKLR1 agonist by On Target Therapeutics (Note: technology
licensed to OKYO Pharma) provided an important step toward the
development of a new class of anti-inflammatory therapeutics that
can be applied to the treatment of ophthalmic diseases including
DED, uveitis and allergic conjunctivitis. (see Figure 2)
To further characterize the potential efficacy of OK-101 to
treat DED, OK-101 was tested in a mouse model of acute dry eye
disease induced with scopolamine that showed an increase in corneal
permeability relative to naïve animals. OK-101 demonstrated a
reduction of DED-induced corneal permeability (p <= 0.001).
OK-101's effect in reducing DED-induced corneal permeability was
virtually identical to that of the cyclosporine positive control
and close to the baseline corneal permeability observed in control
animals.
A separate series of experiments was also performed to evaluate
ocular tolerance of OK-101 in rabbits via repeated ocular
instillation followed by clinical ophthalmic observations. Rabbit
ocular tolerance tests on OK-101 showed no adverse signs such as
inflammation, chemosis or hyperemia and no signs of local
irritation.
We recently completed manufacturing a 25-gram batch of OK-101
drug substance needed for initiating the IND-enabling studies.
Future OK-101 DED Strategy
Based on the results from the DED animal model and ocular
tolerance studies, we are presently moving forward with plans to
file an IND in the third quarter of 2022 on OK-101 to treat DED.
This should enable us to begin clinical trials with OK-101 as early
as one month after submission of the IND to FDA. To support this
work, we recently signed an agreement with a major clinical CRO
specializing in ophthalmic drug development who will be providing
the following services:
-- Preparation of the OK-101 Pre-IND briefing document
-- Support in requesting and preparing for the OK-101 Pre-IND meeting with FDA
-- Support for regulatory publishing and submission of IND in eCTD format
-- Providing quality oversight for development of topical formulation for OK-101
-- Providing quality oversight for development and qualification
of a drug stability analysis method for OK-101 along with
conducting stability studies to establish formulated drug product
is stable for at least 90 days
-- Support for completing animal toxicology studies in two animal species
2) OK-101 for Non-ophthalmic Indications
On January 19, 2021, we announced that we submitted a patent
application to the United States Patent and Trademark Office
covering the use of chemerin and chemerin analogues to treat the
cytokine release syndrome associated with COVID-19 infections and
other conditions such as acute respiratory distress syndrome
(ARDS). On January 15, 2021 we signed a research and material
transfer agreement with the University of Alabama at Birmingham to
evaluate the potential of chemerin analogs to minimize the
inflammation triggered by SARS-CoV-2 in a model of lung
inflammation. Ex vivo lung tissue will be experimentally induced to
produce inflammation, and during the course of inflammation in the
absence and presence of a chemerin analogue, respectively, a panel
of cytokines including TNF<ALPHA>, IL-6, IL-1<BETA>
will be measured. Currently, experiments are underway at the
University of Alabama, but there is nothing to report yet on the
results of this study. Assuming the results are encouraging, our
plan is to advance this program as a potential prophylaxis to treat
COVID-19 infections, and other conditions such as acute respiratory
distress syndrome (ARDS). We plan this work to be under the
direction of Dr. Napoleone Ferrara, a member of our Scientific
Advisory Board.
3) OK-201 to treat corneal neuropathic pain
Our current focus is to develop first-in-class drug candidates
as non-opioid analgesics for ocular pain management without side
effects and the potential abuse associated with opioid medications.
Ocular pain occurs in several ophthalmic conditions including DED,
uveitis, diabetic retinopathy (DR), accidental trauma, surgery, and
is typically treated with oral steroids, neurotransmitters and
opioids in severe cases. There is no FDA approved drug yet for
ocular pain in the form of eye drops. Damage to the ocular surface
(nociceptive pain in response to inflammation) or to the
somatosensory nervous system (chronic neuropathic pain) due to the
underlying pathogenesis of eye disease is the main cause of
pain.
A lipidated BAM analogue (OK-201), a promising candidate for the
treatment of neuropathic and inflammatory pain, was licensed from
Tufts Medical Center (TMC), Boston, MA on February 21, 2018. OK-201
is designed to activate a human MAS-Related G Protein-coupled
Receptor (MRGPR), which is a promising analgesic target. This
receptor is expressed mainly in sensory neurons and is involved in
the perception of pain. Activation of MRGPR by BAM peptide inhibits
pain by modulating Ca2+ influx. On August 6, 2019 we signed a
collaborative agreement with TMC and Pedram Hamrah, MD, Professor
of Ophthalmology at Tufts University School of Medicine, Boston, MA
as Principal Investigator to evaluate our proprietary lead
compounds as non-opioid analgesics to suppress corneal neuropathic
pain using a mouse ocular pain model developed in Dr. Hamrah's
laboratory. Since acquiring the rights to OK-201, we have
synthesized a small library of lipidated BAM analogues. The
potencies of these analogues were determined using a cell-based
assay, and a small number of these analogues were evaluated for
their analgesic properties in the neuropathic pain model developed
by Dr. Hamrah's laboratory at TMC. These collaborative studies have
provided additional 'proof-of-concept' results for BAM analogues as
potential non-opioid analgesics. Our goal is to develop OK-201, as
well as explore additional analogues for their potential use in
treating ocular pain.
Future OK-201 Strategy
During the next year, we will be continuing to conduct
preclinical studies and additional animal studies to further
evaluate the OK-201 preclinical candidate to treat corneal
neuropathic pain.
Financial summary
Consolidated Statement of Comprehensive Income
The Group has made a loss for the year of GBP2,994k ( 2020 :
GBP1,211k). The loss is detailed in the consolidated statement of
comprehensive income on page 37.
The Group's expenditure on research and development was GBP133k
for the year ended March 31, 2021, as compared to GBP407k for the
year ended March 31, 2020. The reduction in expenditure was due an
elimination of R&D costs planned for OK-113 once the decision
was made to switch to OK-101 as the preclinical candidate for
filing an IND with FDA. The activities relating to OK-101 commenced
in the last few months of the period, post the recruitment of the
CEO.
Other operating expenses were GBP2,867k for the year ended March
31, 2021 as compared to GBP800k for the year ended March 31, 2020,
an increase of GBP2,067k. The increase in cost is a result of a
bonus that was awarded in the current year to the Non-Executive
Chairman for GBP887k, (on the basis of the co-invention of the use
of Chemerin in the COVID-19 indication when he was not a director
or employee of the Company (now the subject of a patent
application); work carried out in procuring, backing and completing
the refinancing the Company in 2020 and actions taken to make new
executive appointments and scientific advisory appointments to the
Board with the result that the Company now has a clear and
accelerated path), additional fair value charges of GBP375k
relating to the issuance of additional options, fundraising
expenses of GBP453k plus additional compliance, professional fees,
legal and foreign exchange costs of GBP352k due to increased
activity in the Company in the last 3 months of the period.
Consolidated Statement of Financial Position
At the end of the year, the Group cash balance stood at
GBP4,991k (31 March 2020: GBP190k). The Group successfully raised
GBP6,070k during the year via the issuance of Convertible loan
notes, private placements, and the exercise of options.
Fund raising
In the period, the Group successfully raised funds to further
progress its pre-clinical pipeline.
On 23 May 2020, the Group announced that further to the
announcement made on 23 March 2020, the Group raised GBP181,346
through a placing of a further 36,269,253 new ordinary shares.
On 29 May 2020, the Group announced that it had raised
GBP440,000 through the issue of convertible loan notes ("CLNs").
GBP50,000 of the CLN's were issued to Panetta Partners Ltd, the
ultimate parent company. The CLNs carry an interest rate of 20%
compounding and have maximum term of 4 years. The CLNs convert into
ordinary shares at a price of 0.4p per share and, when converted,
the shares will be issued with a warrant attached at an exercise
price of 0.4p (with a maximum life of 5 years from the date of
issue of the CLN, regardless of the conversion date).
On 28 July 2020, the Group announced that it had raised GBP3.5m
through the issuance of CLN's. The CLNs carry an interest rate of
2.15% compounding and have maximum term of 4 years. The CLNs
convert into ordinary shares at a price of 8.5p per share.
On 17 August 2020, the Group announced that it had raised a
further GBP1.437m through the issuance of CLN's. The CLNs carry an
interest rate of 2.15% compounding and have maximum term of 4
years. The CLNs convert into ordinary shares at a price of 8.5p per
share.
On 8 September 2020, the Group announced that it had raised a
further GBP0.5m through the issuance of CLN's. The CLNs carry an
interest rate of 2.15% compounding and have maximum term of 4
years. The CLNs convert into ordinary shares at a price of 8.5p per
share.
In March 2021, additional funds of GBP11,250 were raised through
the exercise of options.
Going Concern
The Group has experienced net losses and significant cash
outflows from cash used in operating activities over the past
years, and as of March 31, 2021, had an accumulated loss of
GBP72.5m, a net loss for the year ended March 31, 2021 of GBP3m and
net cash used in operating activities of GBP1.2m.
Based upon the current forecasts prepared by Management, the
potential use of cash flows from operations from the date of
approval of these accounts until 31 December 2022 is GBP4.4
million, of which GBP2.5m is to be spent on progressing the R&D
pipeline. When compared to the current cash balance at June 10,
2021 of GBP4.7 million, management projects a surplus of GBP0.3
million, thereby supporting Management's assertion that the Company
does have the ability to meet its obligations as they become due
until December 2022.
However, further funds will need to be raised within the
foreseeable future in order to progress it's pipeline and fund
ongoing business operations. The Directors are confident, based on
the previous fund-raising history that sufficient funds will be
forthcoming and accordingly they have prepared these financial
statements on a going concern basis. However, until and unless the
Group and Company secures sufficient investment to fund its
pipeline, there is a material uncertainty about the Group and
Company's ability to continue as a going concern, and therefore
about the applicability of the going concern basis of
preparation.
COVID-19
We remain cognisant of the potential impact of coronavirus
(COVID-19) on our operations and have taken the steps necessary to
maintain the integrity of the Company's assets and the health and
wellbeing of our employees. The Company is well financed, resilient
and well positioned to weather any financial downturn occurring as
a result of the outbreak. Indeed, the Company has raised additional
funds through the issuance of Convertible Loan Notes.
Remote working and outsourcing of research and development
activities has meant that progression of the project pipeline is
not impacted by the pandemic.
Outlook and Strategy
The development of new drugs to treat DED has been particularly
challenging due to the heterogeneous nature of the patient
population suffering from DED, and due to the difficulties in
demonstrating an improvement in both signs and symptoms of the
disease in well-controlled clinical trials. The evidence from over
40 years of scientific literature, however, suggests inflammation
as the most common underlying cause of DED. Consequently,
development of new therapeutic agents that target inflammatory
pathways is looking to be an attractive approach in improving
symptoms in DED patients.
During the next 12 months, OKYO is committed to a major effort
to accomplish the IND enabling activities necessary for filing an
IND on OK-101 to treat DED. These include:
-- Topical formulation of the OK-101 drug product and initial stability studies
-- Bioanalytical method development to support the OK-101 clinical program
-- Engineering batch manufacture of cGMP OK-101 for clinical trials
-- Toxicokinetic method development
-- Toxicology studies in rabbits and dogs
-- Clinical batch manufacturing and stability studies of OK-101
Once an IND on OK-101 to treat DED is in place, the virtue of
OK-101 being formulated as a topical drug that can be administered
to patients in the form of eye drops, means that our first clinical
trial after IND submission is expected to be a Phase 1/2a trial in
DED patients, potentially providing an early indication of drug
efficacy in DED patients. Should drug efficacy be borne out in this
first human trial with OK-101, we will have validated
proof-of-concept in this very first study. With this success in
hand, we believe that rapid further clinical development of OK-101
to treat DED will be in order. We anticipate that OK-101, in
addition to its potential to treat DED, can then also be evaluated
to treat uveitis and allergic conjunctivitis. Hence, once we are
clinically evaluating OK-101 to treat dry eye, we will also
undertake the plan to explore the drug candidate's potential to
suppress the inflammation associated with uveitis and allergic
conjunctivitis. In support of this plan, we will be exploring
preclinical development of OK-101 for the uveitis indication by
first establishing 'proof-of-concept' for this indication utilizing
animal model studies of anterior uveitis to evaluate the potential
of OK-101 to suppress the inflammation associated with uveitis. We
also plan on conducting 'proof-of-concept' studies using OK-101 for
the treatment of chronic and seasonal allergic conjunctivitis using
a conjunctival allergen challenge animal model to investigate the
potential of OK-101 to suppress the inflammation associated with
allergic conjunctivitis.
We will also continue to explore the potential use of chemerin
and chemerin analogues for prophylaxis against and treatment of
symptoms associated with, or resulting from, infection with
SARS-CoV-2 virus, including inflammation due to the cytokine storm
caused by COVID-19 disease and acute respiratory distress
syndrome.
Business review
A review of the business, its results and strategic outlook is
included in the Executive Chairman's Statement on page 2.
Key performance indicators
The Board monitors the Key Performance Indicators (KPIs) that it
considers appropriate for the industry and stage of development of
the Group. The Group is a research and development ("R&D")
based biotechnology Group concerned with a number of pre-clinical
projects. These projects require sufficient investment to reach
defined milestones by which the Group and its investors can judge
the chances of ultimate success and thereby the value of the Group.
At this stage of Group development significant sources of revenue
generation are unlikely, and due to the needs of an R&D based
biotechnology-based program, the Group is cash consuming. The Group
KPIs are therefore chosen to monitor the progress of the individual
scientific programmes, the external market environment for the
potential drugs being developed and the cash requirements of the
Group.
Financial KPIs
Cash consumption
The cash position of the business is measured on a continual
basis with reference both to the general and administrative
expenses required to run the Group, and more particularly to the
cash required for ongoing research, development and acquisition of
the Group's scientific assets. During 2020, the main use of the
Group's funds was progressing the animal model trials for OK-101
and OK-201, which was within the budget. The cash consumption,
which refers to cash used in operating activities of the Group,
during the year was GBP1.3m. Management monitors its cash
consumption on a monthly basis and a cash projection will be
presented at every board meeting.
The Group monitors current and projected cash consumption to
ensure that there are sufficient funds available to develop the
Group's scientific assets. The Group maintains a virtual operating
model resulting in low cash consumption for general and
administrative expenses during the period.
Non-financial KPIs for 2021.
Develop appropriate formulation of OK-101 for animal studies,
and conduct stability studies to ensure that the formulation is
stable for at least 28 days.
The Group is working towards this KPI. Additional preclinical
IND-enabling studies have been performed and peptide manufacturing
process has been scaled up to produce larger quantities of OK-101
for stability studies. A dose ranging study in rabbit was performed
to evaluate the effect of OK-101 on corneal permeability and to
assess local corneal irritation. OK-101 was found to be effective
in reducing corneal permeability and to show no sign of local
irritation. Rabbit ocular tolerance tests using OK-101 showed no
adverse signs such as inflammation, chemosis or hyperemia and no
signs of local irritation.
Other Considerations
External (life sciences) market environment
The Group monitors the life sciences market for a number of
factors:
-- New developments in drug research and development
-- New medical treatment paradigms
-- Patent filings by third parties pertinent to the Group's programmes
-- Existing and novel drugs in development by third parties
-- Healthcare regulation and policy in the major territories
-- Private and public financings of life science companies to
indicate investor appetite for life science risk
The Group is developing its scientific assets within the
European and US territories, but for potential global application.
The environment for life science companies was positive throughout
the year.
Principal risks and uncertainties
The Group assesses and monitors the inherent risks in the life
sciences industry, as well as other micro and macro-economic
factors that may present risk to the Group's progression. The Group
also considers Group-specific risks such as research progress,
personnel and operational facilities and collaborations.
There are significant risks associated with any life science
business. The Board believes that the following risks are the most
significant, however, the risks listed do not necessarily comprise
all those associated with an investment in the Group. In
particular, the Group's performance may be affected by changes in
market or economic conditions and in legal, regulatory and / or tax
requirements. The risks listed are not set out in any particular
order of priority and this is not an exhaustive list of risks.
If any of the following risks were to materialise, the Group's
business, financial condition, results or future operations could
be materially and adversely affected. In such cases, the Group's
share price may decline and an investor may lose part or all of
their investment.
The Board considers that the principal risks and uncertainties
facing the Group may be summarised as follows:
-- Clinical studies fail to generate encouraging data
The Group's product candidates have not been evaluated in
clinical trials and results in the clinic may not be reproduced in
human trials. There is a high degree of failure for product
candidates as they progress through clinical trials and clinical
trial data may be interpreted in varying ways which may delay,
limit or prevent future regulatory approvals.
-- Ability to scale up the Group
Growth may place significant demands on the Group's management
and resources. The Group expects to experience growth in the number
of its employees and the scope of its operations in connection with
the continued development and, in due course, the potential
commercialisation of its products. This potential growth could
place a significant strain on its management and operations, and
the Group may have difficulty managing this future potential
growth.
-- Intellectual property risk
The commercial success of the Group depends on its ability to
obtain patent protection for its pharmaceutical discoveries and to
preserve the confidentiality of its know-how. There is no guarantee
that patent applications will succeed or be broad enough to provide
protection for the Group's intellectual property rights and exclude
competitors with similar pharmaceutical products. The success of
the Group is also dependent on non-infringement of patents, or
other intellectual property rights, held by third parties.
Competitors and third parties may hold intellectual property rights
which the Group may not be able to license upon favourable terms,
potentially inhibiting the Group's ability to develop and exploit
its own business. Litigation may be necessary to protect the
Group's intellectual property, which may result in substantial
costs. The Group seeks to reduce this risk by seeking patent
attorney advice that patent protection will be available prior to
investing in a project, by seeking patent protection where
appropriate, and by minimising disclosure to third parties.
-- Competition risk
The Group faces significant competition from pharmaceutical
companies. The Group has competitors internationally, including
major multinational pharmaceutical companies, universities and
research institutions. In respect of Chemerin as an indication for
the treatment of DED, there are a number of established companies
engaged in the development and marketing of preparations addressing
the DED market. In addition, there is a wide range of products
addressing the DED market currently approved and marketed by a
number of large and small pharmaceutical companies.
-- Funding risk
The Group continues to consume cash resources. The Group only
recently committed to its new business and its chosen product
candidates are in the early stages of development and it may be
some years until the Group generates revenue, if at all. The Group
remains dependent upon securing funding through the injection of
capital from share issues. The Group may not be able to generate
positive net cash flows in the future or attract such additional
funding required at all, or on suitable terms. In such
circumstances, the Group's pre-clinical programmes may be delayed
or cancelled and the business operations curtailed. The Group seeks
to reduce this risk through tight financial control, prioritising
programmes which will generate the best returns, and keeping
shareholders informed on progress. Post period-end, the Group
raised GBP3.9 million (before expenses) to fund its pre-clinical
activities and strengthen its balance sheet.
-- Dependence on key personnel
The loss of one or more of its key personnel could have an
adverse impact on the business of the Group. Furthermore, it may be
particularly difficult for the Group to attract and retain suitably
qualified and experienced people, given the competition from other
industry participants and the relative size of the Group. The Group
has deliberately pursued a lean headcount policy to conserve
financial resources. Failure to continue to attract and retain such
individuals could adversely affect the Group's ability to conduct
and grow its operations effectively. The Group seeks to reduce this
risk by recruiting additional personnel and additionally
appropriate incentivisation of personnel through participation in
long term equity incentive schemes.
Gender of Directors and employees
We recruit individuals who have the skills, experience and
integrity needed to perform the roles to make OKYO Pharma Ltd a
successful company. We note that there are no women on the board
but that we recruit without regard to sex or ethnic origin,
appointing and thereafter promoting staff based upon merit.
The profile of the Group's directors, officers and employees at
March 31, 2020, was as follows:
March 31, 2021
----------------------
Male Female Total
----- ------- ------
Number or persons who were
Directors or officers of
the Group 5 1 6
----- ------- ------
Number of persons who were - - -
other employees of the Group
------------------------------- ----- ------- ------
Total Directors and employees
at March 31, 2021 5 1 6
------------------------------- ----- ------- ------
The lean staffing structure is supported by the outsourcing of
some administrative functions and the use of contract research
organisations (CROs).
Directors' duties in relation to s172 Companies Act 2006
The Board of Directors have considered the matters set out in
section 172 of the United Kingdom's Companies Act 2006 insofar as
Guernsey law requires consideration of the same.
The directors consider, that they have acted in the way they
believe, in good faith, to promote the success of the Company for
the benefit of its members as a whole and, in doing so, have regard
(amongst other matters) to:
-- the li kely consequences of any decisions in the
long-term,
-- the interests of the Company's employees,
-- the need to foster the Company's business relationships with
suppliers, customers and others,
-- the impact of the Company's operations on the community and
environment,
-- the desirability of the Company maintaining a reputation for
high standards of business conduct, and
-- the need to act fairly between the shareholders of the
Company.
Principal decisions in 2020
We have considered the decisions taken by the Board which will
have an impact on the longer-term performance and prospects for the
Group. The Board believes that the following decisions taken during
the year and since the year end fall into this category and were
made with full consideration of both internal and external
stakeholders. The Group's aim is to meet the needs of the key
stakeholders who ultimately wish for us to progress our pipeline of
drugs to treat rare cancers and autoimmune and inflammatory
diseases to commercial deployment.
Significant events/decisions Key s172 matter(s) Actions and impact
affected
Raised GBP6m of investment Shareholders Decisions were made by the
from existing and Board to raise additional
new investors, to funds enabling the company
enable Group to progress to pursue its R&D objectives
its pre -clinical thereby meeting core stakeholder
trials requirements. The cash funding
requirement offsets any
dilution experienced by
the existing shareholders.
----------------------- ----------------------------------
Filing of patent Staff and Shareholders Decisions were made by the
application covering executive team in consultation
the use of Chemerin with the Board after carefully
and associated analogues considering impact upon
to treat cytokine existing staff resources
storm associated and available funding. The
with COVID-19 and application has resulted
ARDS in an expanded project focus.
----------------------- ----------------------------------
Environmental matters
We currently outsource our research, development, testing and
manufacturing activities. These activities are subject to various
environmental, health and safety laws and regulations, which
govern, among other things, the controlled use, handling, release
and disposal of and the maintenance of a registry for hazardous
materials and biological materials. If we or our partners fail to
comply with such laws and regulations, we could be subject to fines
or other sanctions.
As with other companies engaged in activities similar to ours,
we face a risk of environmental liability inherent in our current
and historical activities, including liability relating to releases
of or exposure to hazardous or biological materials. Environmental,
health and safety laws and regulations are becoming more stringent.
We may be required to incur substantial expenses in connection with
future environmental compliance or remediation activities, in which
case, our production and development efforts may be interrupted or
delayed.
Gabriele Cerrone
Non-Executive Chairman
31 July 2021
Martello Court, Admiral Park, St Peter Port, Guernsey, GY1
3HB
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
ACSDKBBBKBKDOFK
(END) Dow Jones Newswires
August 02, 2021 06:32 ET (10:32 GMT)
Okyo Pharma (LSE:OKYO)
Historical Stock Chart
From Mar 2024 to Apr 2024
Okyo Pharma (LSE:OKYO)
Historical Stock Chart
From Apr 2023 to Apr 2024