TIDMIMM
RNS Number : 4390P
Immupharma PLC
29 May 2018
29 MAY 2018
ImmuPharma PLC
("ImmuPharma" or the "Company")
FINAL RESULTS ANNOUNCEMENT
for the twelve months ended 31 December 2017
ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the
specialist drug discovery and development company, is pleased to
announce its final results for the twelve months ended 31 December
2017 (the "Period").
Key Highlights (including post Period review)
-- Stable financial performance over the Period, in line with market expectations
o Cash balance of GBP2.7 million (31 December 2016: GBP1.9
million) which has since been augmented by the GBP10 million
(before expenses) placing in January 2018.
o Loss for the period of GBP6.2 million (31 December 2016:
GBP5.3 million)
-- Research and development expenses of GBP5.1 million (31
December 2016: GBP5.3 million)
o Basic and diluted loss per share of 4.75p (31 December 2016:
4.54p)
-- The Company's pivotal Phase III trial of Lupuzor(TM), the
Company's potential breakthrough compound for lupus, a potential
life threatening auto-immune disease, completed in January 2018
o Pivotal Phase III trial with 202 lupus patients
-- 11 sites in the US with 72 patients
-- 81 patients took part in the trial across 5 European
countries: France, Germany, Hungary, Czech Republic and Poland
-- 49 patients in Mauritius included in trial
-- Top line results of the Company's pivotal Phase III trial of
Lupuzor(TM) were announced on 17 April 2018- key highlights
include:
o Lupuzor(TM) plus Standard of Care ("SOC")* demonstrated a
superior response rate over placebo plus SOC (52.5% vs 44.6%
"responders"**) in the primary analysis on the Full Analysis Set of
all 202 patients (including withdrawals who are considered
non-responders). However, due to a high response rate in the
placebo plus SOC group, this superior response did not allow
statistical significance to be reached (p = 0.2631) and the primary
end point was not met.
o Lupuzor(TM) plus SOC also demonstrated a superior response
rate over placebo plus SOC (68.8% vs 59.2%) in the 153 patients who
completed the study.
o Importantly, in patients who were anti-dsDNA autoantibody
positive (a recognised biomarker for Systemic Lupus Erythematosus
('SLE'), Lupuzor(TM) plus SOC demonstrated a superior response rate
over placebo plus SOC (61.5% vs 47.3%). In addition, 7.6% of the
patients in the Lupuzor(TM) plus SOC group went into full remission
versus none in the placebo plus SOC group.
o The study confirmed the outstanding safety profile of
Lupuzor(TM), with zero drug-related serious adverse events reported
in the Lupuzor(TM) plus SOC group.
* "Standard of Care" includes treatment with other drugs such as
steroids, anti-malarials, methotrexate etc. It is important to note
that when reference is made to placebo, there are no patients who
were treated with just placebo as all were receiving other drug
treatments at the same time, in addition to Lupuzor(TM) .
** The definition of a "responder' is based on the SLE Responder
Index (SRI-4) score, which requires a reduction of at least four
points in this score. Therefore, patients who improve by less than
four points are not counted, but also no distinction is made
between patients who improve by more than 4 points, all being equal
"responders".
-- Follow-on 'extension' open label study
o As announced on 18 January 2018, following requests from both
investigators and patients involved in the Phase III trial,
ImmuPharma has initiated an additional clinical trial permitting
patients who participated in the Phase III study, to receive
Lupuzor(TM) plus SOC for six months in an open-label scheme.
Patient recruitment began in late 2017.
o 44 patients have already been recruited with recruitment being
closed by the end of June 2018.
o Results are anticipated in 2019.
-- Two successful, value accretive fundraisings to strengthen
the Company's financial position as
negotiations continue with potential partners for Lupuzor(TM)
and to support further investment in
ImmuPharma's product pipeline
o GBP4.1 million (gross) fundraising completed in March 2017,
including EIS qualifying shares
o GBP10 million (gross) fundraising in January 2018
o Both fundraisings were supported by existing long term
shareholders together with the addition of new institutional
investors and private investors
-- Other program developments
o ImmuPharma's subsidiary, Ureka, whose labs are based in
Bordeaux at the facilities of the CNRS has discovered inter alia a
new drug for the treatment of NASH (Non-Alcoholic-Steato-Hepatitis)
and Type II diabetes which has demonstrated significant efficacy in
recognised preclinical studies. ImmuPharma's new lead candidate in
this therapeutic area is code-named URK-614 and is a very
long-acting GLP-1 analogue with potential for once a month
administration. This promising novel molecule is protected by a
series of patents co-owned by Ureka and CNRS under the umbrella of
Ureka's URELIX(TM) technologies which facilitates the fabrication
of new drug compounds on the basis of physiologically active
peptides.
o A number of options are under review to further progress
ImmuPharma's Nucant program, IPP-204106 which showed promising
results in cancer and age-related macular degeneration (AMD)
models. Two Phase I trials have been completed (safety and
dose-finding studies).
-- Bryan Garnier & Co. appointed as Joint Broker on 28 March 2018
Commenting on the statement and outlook Tim McCarthy, Chairman,
said:
"As a Board, we continue to be excited by ImmuPharma's future
potential. Looking at the Lupuzor(TM) top line data announced in
April, the drug demonstrated a superior response rate over placebo
with an exceptional safety profile, giving it, we believe, a
compelling product profile. We believe Lupuzor(TM) has the
potential to bring a much needed safe treatment to the millions of
lupus sufferers around the world. The Company's remaining product
pipeline is also promising with notable developments in NASH and
Type II diabetes in particular. We continue to engage with
potential partners and are focused on moving forward with the
development and commercialisation of Lupuzor(TM) for lupus.
Although no guarantees of a successful outcome can be given at this
stage, we look forward to providing our shareholders with further
updates in due course.
"With a strong balance sheet following the GBP10 million fund
raising in January, ImmuPharma will look to progress its other
earlier stage pipeline candidates whilst also exploring other
opportunities based on Lupuzor(TM) 's mechanism of action and its
potential to expand into other autoimmune conditions.
"The Board would like to thank its shareholders, both long
standing and new for their support as well as its staff, scientific
and corporate collaborators including the CNRS, Simbec-Orion and
CAP Research."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014. ("MAR")
For further information please contact:
+ 44 (0)
ImmuPharma plc (www.immupharma.org) 20 7152 4080
Tim McCarthy, Chairman
Lisa Baderoon, Head of Investor Relations + 44 (0)
Twitter: @immupharma 7721 413496
Northland Capital Partners Limited
(NOMAD & Joint Broker)
David Hignell, Dugald Carlean, Jamie
Spotswood, Corporate Finance +44 (0)20
Rob Rees, Corporate Broking 3861 6625
Bryan, Garnier & Co. (Joint Broker)
Phil Walker, Corporate Finance +44 (0)20
Dominic Wilson, Sales 7332 2500
ImmuPharma plc
Chairman's Report
2017 and the beginning of 2018 marked an important milestone
event for ImmuPharma. The phase III clinical trial for our lead
program, Lupuzor(TM) was completed, and top line results for the
trial were announced post year-end. ImmuPharma completed two
successful fundraising rounds raising a total of GBP14.1 million
before expenses. In March 2017, the Company raised GBP4.1 million
before expenses. In addition, a further GBP10 million fundraising
round before expenses was completed in January 2018. These
fundraisings were supported by existing long term shareholders
together with the addition of new institutions and private
investors onto our share register.
Lupuzor(TM) : progress through 2017
Lupuzor(TM) , ImmuPharma's lead program for the treatment of
lupus completed its Phase III clinical trial in January 2018 which
involved patients in the US, Europe and Mauritius. Initial top line
results were announced on 17 April 2018, see details below.
The Phase III trial was a double-blind, randomised,
placebo-controlled trial. The study involved patients being dosed
for one year, receiving 0.2mg once per month subcutaneously. 293
patients were screened illustrating the demand from physicians for
a new, safe and effective treatment for lupus. Of these, the
required 202 patients were successfully recruited and randomised
(dosed). Patients participated in the trial in 7 countries across
28 sites.
The clinical trial was undertaken primarily by Simbec-Orion, an
international clinical research organisation, who specialises in
rare and orphan conditions and has previous direct experience in
lupus trials. This was a pivotal study designed to demonstrate the
safety and efficacy of Lupuzor(TM) .
Lupuzor(TM) received approval from the US Food and Drug
Administration (FDA) to start Phase III with a Special Protocol
Assessment (SPA) and Fast Track designation.
Lupuzor(TM) Phase III Top Line Results
On 17 April 2018 ImmuPharma announced top line results of its
pivotal Phase III trial of Lupuzor
Key highlights:
-- Lupuzor(TM) plus Standard of Care ("SOC")* demonstrated a
superior response rate over placebo plus SOC (52.5% vs 44.6%
"responders")** in the primary analysis on the Full Analysis Set of
all 202 patients (including withdrawals who are considered
non-responders). However, due to a high response rate in the
placebo plus SOC group, this superior response did not allow
statistical significance to be reached (p = 0.2631), and the
primary end-point was not met.
-- Lupuzor(TM) plus SOC also demonstrated a superior response
rate over placebo plus SOC (68.8% vs 59.2%) in the 153 patients who
completed the study.
-- Importantly, in patients who had anti-dsDNA autoantibodies (a
recognised biomarker for Systemic Lupus Erythematosus ('SLE')),
Lupuzor(TM) demonstrated a superior response rate over placebo
(61.5% vs 47.3%). In addition, 7.6% of these patients in the
Lupuzor(TM) group went into full remission versus none in the
placebo group.
-- The study confirmed the outstanding safety profile of
Lupuzor(TM), with zero drug-related serious adverse events reported
in the Lupuzor(TM) plus SOC group.
* "Standard of Care" includes treatment with other drugs such as
steroids, anti-malarials, methotrexate etc. It is important to note
that when reference is made to placebo, there are no patients who
were treated with just placebo as all were receiving other drug
treatments at the same time, in addition to Lupuzor(TM) .
** The definition of a "responder' is based on the SLE Responder
Index (SRI-4) score, which requires a reduction of at least four
points in this score. Therefore, patients who improve by less than
four points are not counted, but also no distinction is made
between patients who improve by more than 4 points, all being equal
"responders".
Extension Open Label Study
Following requests from both investigators and patients involved
in the Phase III trial, ImmuPharma has initiated an additional
clinical trial permitting patients who participated in the Phase
III study, to receive Lupuzor(TM) plus SOC for six months in an
open-label scheme. The results will be gathered as an "extension"
open label study, independent of the pivotal Phase III trial and
will provide additional data on the safety and efficacy of
Lupuzor(TM) . Patient recruitment began in late 2017 and 44
patients have already been recruited. Patient recruitment will be
closed by the end of June 2018, and it is anticipated that results
will be available in 2019.
Lupus Market
There are an estimated five million people globally suffering
from lupus, with approximately 1.5 million patients in the US,
Europe and Japan (Source: Lupus Foundation of America). Current
'standard of care' treatments, including steroids and
immunosuppressants, can potentially have either serious side
effects for patients or limited effectiveness, with over 60 per
cent of patients not adequately treated.
The Company beieves Lupuzor(TM) has the potential to be a novel
specific first-line drug therapy for the treatment of lupus by
specifically modulating the immune system and halting disease
progression in a substantial proportion of patients. Lupuzor(TM)
has a unique mechanism of action that modulates the activity of CD4
T-cells which are involved in the cell-mediated immune response
which leads to the lupus disease. Lupuzor(TM) , taken over the long
term, as indicated in earlier stage clinical trials, has the
potential to prevent the progression of lupus rather than just
treating its symptoms, with the rest of the immune system retaining
the ability to work normally.
Despite the top line results for the Phase III trial, the Board
believes there are still a number of routes to market for
Lupuzor(TM) which could include: a global licensing deal;
ImmuPharma partnering with regional distributors, globally or an
outright acquisition of Lupuzor(TM) or the Company. The prime
objective of any strategy would be to maximise shareholder
return.
Centre National de la Recherché Scientifique (CNRS)
ImmuPharma continues to have important collaboration
arrangements with the Centre National de la Recherché Scientifique
(CNRS), the French National Council for Scientific Research and the
largest basic research organisation in Europe, relating to the
therapeutic use of peptides and peptide derivatives. This is where
Lupuzor(TM) was invented by Prof. Sylviane Muller, Research
Director at CNRS. This successful and longstanding relationship
plays an important role in the progress of ImmuPharma's development
pipeline.
Pipeline Overview
Lupuzor(TM) / Forigerimod / P140 in Autoimmune Indicaitons
Lupuzor(TM) , is also known by its chemical name 'Forigerimod'
or P140. ImmuPharma in conjunction with the CNRS are exploring
opportunities on expanding into other auto immune indications, as
demonstrated by Lupuzor(TM) 's profile and by its mechanism of
action.
Certain auto immune indications, outside of lupus, have the
potential for Orphan Drug designation. Further assessment continues
with the objective of further indications moving into the clinic in
due course.
Nucant Program
Our cancer Nucant program, IPP-204106, is focused on combination
therapy approaches. Two Phase I/IIa trials were performed (focused
on safety and dose-range finding). ImmuPharma is now reviewing a
number of options to further progress this program. A grant was
awarded by the EU to different EU partners (EUR7 million total with
EUR430k awarded to ImmuPharma) to develop the Nucants in
combination with cytotoxic drugs linked to a solid support. The
molecule has also shown promising results in age-related macular
degeneration models.
Peptide Platform
ImmuPharma's subsidiary 'Ureka' has also initiated the
development of a novel and innovative peptide technology platform
through the collaboration with CNRS, thereby gaining access to
pioneering research centred on novel peptide drugs at the
University of Bordeaux and the Institut Européen de Chimie et
Biologie (IECB). Jointly, ImmuPharma and CNRS have filed a series
of new co-owned patents controlling this breakthrough peptide
technology. The first therapeutic area being targeted is diabetes
with glucagon-like peptide -1 agonists, a class of drugs for the
treatment of diabetes, as well as initiating the development of
novel peptides as glucagon agonists - one of the novel approaches
to treat Type I and Type II diabetes. These peptides could also
have a beneficial effect in the treatment of NASH for which very
few treatment options exist.
GBP14.1 million Fund Raising (GBP4.1 million in March 2017 and
GBP10 million post period end)
ImmuPharma strengthened its financial position through two
fundraisings. In March 2017, the Company announced the completion
of a placing of 7,884,623 new ordinary shares of 10p each at a
placing price of 52p raising a total of GBP4.1 million before
expenses. The shares are EIS and VCT qualifying. Major existing and
new institutional investors participated in the New Share
Placing.
In January 2018, the Company announced the completion of a
placing of 6,944,445 new ordinary shares of 10p each at a placing
price of 144p raising a total of GBP10 million before expenses. The
Company raised the funds in order to further strengthen the
Company's financial position as negotiations continue with
potential partners for Lupuzor(TM) and to support further
investment in ImmuPharma's earlier stage portfolio. The Company
continues to be a qualifying company for purposes of the Enterprise
Investment Scheme and the Venture Capital Trust rules.
The January 2018 placing gross proceeds of GBP10 million added
to the Group's cash and cash equivalent position of GBP2.7 million
(2016: GBP1.9 million) at 31 December 2017.
Completion of Lanstead Sharing Agreement
In September 2017, ImmuPharma announced the completion of the
Sharing Agreement entered into in February 2016. As announced on 5
February 2016, Lanstead subscribed for GBP4.4 million of new
ordinary shares in ImmuPharma, with both parties also entering into
the Sharing Agreement. All 18 settlements of the Sharing Agreement
have been completed. Through both the subscription and the Sharing
Agreement, ImmuPharma has received a total of just over GBP5
million from Lanstead since February 2016, with a net gain of
GBP0.6 million more than originally subscribed.
New Share Option Plan
Following the closing of the Company's previous share option
plan to new grants, ImmuPharma adopted a new 10 year employee share
option plan. The implementation of this share option plan is
intended to align the interests of the Company's executive
directors and eligible employees with shareholders, and to attract
talent in the future. Further details of the new share option plan
can be found in the Financial Review.
Current Activities and Outlook
As a Board, we continue to be excited by ImmuPharma's future
potential. Looking at the Lupuzor(TM) top line data announced in
April, the drug demonstrated a superior response rate over placebo
with an exceptional safety profile, giving it, we believe, a
compelling product profile. We believe Lupuzor(TM) has the
potential to bring a much needed safe treatment to the millions of
lupus sufferers around the world. We continue to engage with
potential partners and, although no guarantees of a successful
outcome can be given at present, we are focused on moving forward
with the development and commercialisation of Lupuzor(TM). The
remaining pipeline is also very promising with notable developments
in NASH and Type II diabetes. We look forward to providing our
shareholders with further updates in due course.
With a strong financial position following the recent GBP10
million fund raising, ImmuPharma will look to progress its other
pipeline candidates whilst continuing the development of
Lupuzor(TM) , in lupus as well as other autoimmune conditions based
on its mechanism of action.
The Board would like to thank its shareholders, both long
standing and new for their support as well as its staff, scientific
and corporate collaborators including the CNRS, Simbec-Orion and
CAP Research.
Tim McCarthy
Non-Executive Chairman
ImmuPharma plc
Financial Review
2017 was a year focused on strengthening ImmuPharma's financial
position and progressing our lead programme, Lupuzor(TM) and its
pivotal Phase III trial. A successful share placing was completed
in March 2017, raising GBP4.1 million (before expenses).
Income Statement:
The operating loss for the year ended 31 December 2017 was
GBP7.2 million up from GBP6.6 million for the year ended 31
December 2016. The increase in overall loss was mainly attributable
to share-based expense of GBP743k (2016: GBP89k) which was
attributable to the number of share options granted in 2017.
Research and development expenditure was GBP5.1 million down
slightly from GBP5.3 million in 2016. This reflects the
front-loading of a portion of the Lupuzor clinical trial expenses.
Administrative expenses were GBP1.5 million up from GBP1.4 million
in the year ended 31 December 2016. Finance income was GBP240k for
2017 which was down slightly from GBP298k for 2016. Finance income
is mainly attributable to a gain in fair value on the derivative
financial asset. Total comprehensive loss for the year was GBP6.3
million, which was up from GBP5 million in 2016.
Statement of Financial Position:
Cash and cash equivalents at 31 December 2017 amounted to GBP2.7
million (2016: GBP1.9 million). Financial borrowings were GBP260k
(2016: GBP360k). This balance is primarily the conditional advance
from the French Government for use in the development of our cancer
program. No interest is payable. In March 2017, ImmuPharma
successfully completed a share placing and subscription, raising
GBP4.1 million before expenses. In addition, a further share
placing, raising GBP10 million before expenses was completed in
January 2018. Further details can be found below.
Results:
The Group recorded a loss for the year of GBP6.2 million (2016:
GBP5.3 million). Basic and diluted loss per share was 4.75p (2016:
4.54p). In accordance with the Group's loss making position no
dividend is proposed.
March 2017 and January 2018 (post period) Placings - GBP14.1
million before expenses raised
ImmuPharma strengthened its financial position through two
fundraisings. In March 2017, the Company announced the completion
of a placing of 7,884,623 new ordinary shares of 10p each at a
placing price of 52p raising a total of GBP4.1 million before
expenses. The shares are EIS and VCT qualifying. Major existing and
new institutional investors participated in the New Share
Placing.
In January 2018, the Company announced the completion of a
placing of 6,944,445 new ordinary shares of 10p each at a placing
price of 144p raising a total of GBP10 million before expenses. The
Company raised the funds in order to further strengthen the
Company's Statement of Financial Position as negotiations continue
with potential partners for Lupuzor(TM) and to support further
investment in ImmuPharma's earlier stage portfolio. The Company
continues to be a qualifying company for purposes of the Enterprise
Investment Scheme and the Venture Capital Trust rules.
Completion of Lanstead Sharing Agreement
In September 2017, ImmuPharma announced the completion of the
Sharing Agreement entered into in February 2016. As announced on 5
February 2016, Lanstead subscribed for GBP4.4 million of new
ordinary shares in ImmuPharma, with both parties also entering into
the Sharing Agreement. All 18 settlements of the Sharing Agreement
have been completed. Through both the subscription and the Sharing
Agreement, ImmuPharma has received a total of just over GBP5
million from Lanstead since February 2016, with a net gain of
GBP0.6 million more than originally subscribed.
New Share Option Plan
Following the closing of the Company's previous share option
plan to new grants, ImmuPharma adopted a new 10 year employee share
option plan. The implementation of this share option plan is
intended to align the interests of the Company's executive
directors and eligible employees with shareholders, and to attract
talent in the future.
The key terms of the Share Option Plan are summarised below:
-- The Share Option Plan is used to grant options over the
Company's ordinary shares of 10p each ("Ordinary Shares") to
ImmuPharma's employees and executive directors;
-- The Company's non-executive directors or any self-employed
individuals who provide consultancy services to the Company will
not be granted options pursuant to the Share Option Plan;
-- Under the Share Option Plan, up to 10% of the Company's
issued share capital at any time is reserved for issuance, measured
over a rolling ten year period. This limit takes into account
Ordinary Shares or treasury shares that could be issued or used to
satisfy existing options;
-- The Company's Remuneration Committee may impose performance
conditions over the grant of options and these conditions may be
varied, substituted or waived as deemed appropriate by the
Remuneration Committee; and
-- Options will be granted with an exercise price equal to the
market value of the Company's shares at the date of grant, i.e. the
closing mid-market price from the preceding business day.
A number of options were granted during 2017. The total options
outstanding under both the 2017 Share Option Plan and the Company's
previous share option plan is 10,130,000, representing 7.64% (7.26%
post January 2018 placing) of ImmuPharma's Ordinary Shares and
total voting rights on a fully diluted basis. The total options
outstanding that have been granted to non-employees and consultants
is 6,085,000. The total warrants outstanding is 153,850. Taken
altogether, there are currently 16,368,850 outstanding options and
warrants, representing 12.35% (11.74% post January 2018 placing) of
ImmuPharma's Ordinary Shares and total voting rights on a fully
diluted basis.
Total Voting Rights
Following the admission of the shares placed in the above 2017
placings to trading on AIM, the Company had a total of 132,522,985
ordinary shares in issue at 31 December 2017 with each share
carrying the right of one vote. Following the post period placing
completed in January 2018, the Company has 139,467,430 ordinary
shares in issue with each share carrying the right of one vote.
Treasury Policy
The policy continues to be that surplus funds of the Group are
held in interest-bearing bank accounts on short or medium
maturities, until commitments to future expenditure are made, when
adequate funds are released to enable future expenditure to be
incurred. The Group's Treasury Policy and controls are
straightforward and approved by the Board.
Financial Strategy
The overall strategy is to maintain a tight control over cash
resources whilst enabling continued progress of the Company's
development assets.
Tracy Weimar
Vice President, Operations and Finance
ImmuPharma plc
CONSOLIDATED INCOME STATEMENT
FOR THE YEARED 31 DECEMBER 2017
Notes Year ended Year ended
31 December 31 December
2017 2016
GBP GBP
Continuing operations
Revenue 150,462 164,784
Research and development
expenses (5,121,388) (5,267,087)
Administrative expenses (1,520,356) (1,398,057)
Share based payment
expense (742,752) (88,801)
Operating loss (7,234,034) (6,589,161)
Finance costs (3,858) (23,085)
Finance income 240,447 297,809
Loss before taxation (6,997,445) (6,314,437)
Tax 774,244 990,421
Loss for the year (6,223,201) (5,324,016)
Attributable to:
Equity holders of the
parent company (6,223,201) (5,324,016)
Loss per ordinary share
Basic and diluted 2 (4.75p) (4.54p)
ImmuPharma plc
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE YEARED 31 DECEMBER 2017
Year ended Year ended
31 December 31 December
2017 2016
GBP GBP
Loss for the financial year (6,223,201) (5,324,016)
Other comprehensive income
Items that may be reclassified
subsequently to profit or
loss:
Exchange differences on
translation of foreign operations (91,568) 317,177
Other comprehensive income/(loss)
for the year, net of tax (91,568) 317,177
Total comprehensive loss
for the year (6,314,769) (5,006,839)
ImmuPharma plc
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 31 DECEMBER 2017
31 December 31 December
2017 2016
Notes GBP GBP
Non-current assets
Intangible assets 482,268 511,088
Property, plant and equipment 161,399 231,901
Total non-current assets 643,667 742,989
Current assets
Trade and other receivables 736,212 1,379,679
Derivative financial
asset - 1,554,866
Cash and cash equivalents 2,729,468 1,876,718
Current tax asset 907,916 1,155,586
Total current assets 4,373,596 5,966,849
Current liabilities
Financial liabilities
- borrowings (142,393) (143,109)
Trade and other payables (929,569) (786,191)
Provisions (57,517) -
Total current liabilities (1,129,479) (929,300)
Net current assets 3,244,117 5,037,549
Non-current liabilities
Financial liabilities
- borrowings (117,297) (219,445)
Provisions (195,989) (15,050)
Net assets 3,574,498 5,546,043
EQUITY
Ordinary shares 13,252,299 12,463,836
Share premium 18,728,519 15,678,054
Merger reserve 106,148 106,148
Other reserves (2,961,017) (3,373,745)
Retained earnings (25,551,451) (19,328,250)
Total equity 3,574,498 5,546,043
ImmuPharma plc
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE YEARED 31 DECEMBER 2017
Other
Other Other reserves-
Merger reserves reserves - Equity Retained
reserve - Translation shares earnings
Share Acquisition reserve to be Total
Share capital premium reserve issued equity
GBP GBP GBP GBP GBP GBP GBP GBP
At 1 January
2016 8,862,246 10,490,920 106,148 (3,541,203) (1,926,850) 1,703,380 (14,004,234) 1,690,407
Loss for the
financial
year - - - - - - (5,324,016) (5,324,016)
Exchange
differences
on
translation
of foreign
operation - - - - 317,177 - - 317,177
Transactions
with owners:
Share based
payments - - - - - 73,751 - 73,751
New issue of
equity
capital 3,601,590 5,798,410 - - - - - 9,400,000
Costs of new
issue of
equity
capital - (611,276) - - - - - (611,276)
At 31
December
2016 12,463,836 15,678,054 106,148 (3,541,203) (1,609,673) 1,777,131 (19,328,250) 5,546,043
Loss for the
financial
year - - - - - - (6,223,201) (6,223,201)
Exchange
differences
on
translation
of foreign
operations - - - - (91,568) - - (91,568)
Transactions
with owners:
Share based
payments - - - - - 504,296 - 504,296
New issue of
equity
capital 788,463 3,311,542 - - - - - 4,100,005
Costs of new
issue of
equity
capital - (261,077) - - - - - (261,077)
At 31
December
2017 13,252,299 18,728,519 106,148 (3,541,203) (1,701,241) 2,281,427 (25,551,451) 3,574,498
Attributable
to:-
Equity
holders of
the parent
company 13,252,299 18,728,519 106,148 (3,541,203) (1,701,241) 2,281,427 (25,551,451) 3,574,498
ImmuPharma plc
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE YEARED 31 DECEMBER 2017
Notes Year ended Year ended
31 December 31 December
2017 2016
GBP GBP
Cash flows from operating
activities
Cash used in operations 3 (5,439,079) (7,191,318)
Tax received 1,021,915 707,135
Interest paid (3,858) (1,917)
Net cash used in operating
activities (4,421,022) (6,486,100)
Investing activities
Purchase of property,
plant and equipment (25,491) (4,731)
Interest received 772 1,722
Net cash used in investing
activities (24,719) (3,009)
Financing activities
(Decrease)/increase
in bank overdraft (290) (1,091)
Loan repayments (114,386) (143,482)
Settlements from Sharing
Agreement 1,667,380 2,690,451
Gross proceeds from
issue of new share capital 4,100,005 9,400,000
Share capital issue
costs (261,077) (611,276)
Funds deferred per Sharing
Agreement - (3,949,230)
------------- -------------
Net cash generated from
financing activities 5,391,632 7,385,372
Net increase in cash
and cash equivalents 945,891 896,263
Cash and cash equivalents
at beginning of year 1,876,718 833,388
Effects of exchange rates
on cash and cash equivalents (93,141) 147,067
Cash and cash equivalents
at end of year 2,729,468 1,876,718
Notes
1 BASIS OF PREPARATION
The financial information set out in this
announcement does not comprise the Group's
statutory accounts as defined in section
434 of the Companies Act 2006 for the year
ended 31 December 2017 or 31 December 2016.
The financial information has been extracted
from the statutory accounts for the years
ended 31 December 2017 and 31 December 2016.
The auditors reported on those accounts;
their reports were unqualified and did not
contain a statement under either Section
498(2) or Section 498(3) of the Companies
Act 2006 in respect of the years ended 31
December 2017 and 31 December 2016 and did
not include references to any matters to
which the auditor drew attention by way of
emphasis.
The Group's statutory accounts for the year
ended 31 December 2016 have been delivered
to the Registrar of Companies, whereas those
for the year ended 31 December 2017 will
be delivered to the Registrar of Companies
following the Company's Annual General Meeting.
The accounting policies are consistent with
those applied in the preparation of the interim
results for the period ended 30 June 2017
and the statutory accounts for the year ended
31 December 2016, which have been prepared
in accordance with International Financial
Reporting Standards ("IFRS").
The financial information is for the year
ended 31 December 2017 and the comparatives
are for the year ended 31 December 2016.
The Group's statutory accounts incorporate
the financial statements of ImmuPharma plc
and other entities controlled by the company
("the subsidiaries"). Control is achieved
where the company has the power to govern
the financial and operating policies of an
investee entity so as to obtain benefits
from its activities.
2 LOSS PER SHARE Year ended Year
- Group 31 December ended
2017 31 December
2016
GBP GBP
Loss
Loss for the purposes of basic
loss per share being net loss
after tax attributable to
equity shareholders (6,223,201) (5,324,016)
Number of shares
Weighted average number of
ordinary shares for the purposes
of basic earnings per share 130,902,857 117,340,467
Basic loss per share (4.75)p (4.54)p
Diluted loss per share (4.75)p (4.54)p
There is no difference between basic loss
per share and diluted loss per share as the
share options are anti-dilutive.
3 CASH USED IN OPERATIONS
Group Group
31 December 31 December
2017 2016
GBP GBP
Operating loss (7,234,034) (6,589,161)
Depreciation
and amortisation 138,198 121,337
Share-based payments 504,296 73,751
Decrease/(increase)
in trade and
other receivables 643,466 (387,713)
Increase/(decrease)
in trade and
other payables 143,378 (403,414)
Increase/(decrease)
in provisions 238,456 15,050
Gain/(loss) on
foreign exchange 127,161 (21,168)
Cash used in
operations (5,439,079) (7,191,318)
4 SUBSEQUENT EVENTS
On 24 January 2018, the Company announced
the completion of a placing of 6,944,445
new ordinary shares of GBP0.10 each at a
placing price of GBP1.44 raising a total
of GBP10 million before expenses. Major existing
and new institutional investors have participated
in the New Share Placing. The Company raised
the funds in order to support further investment
in the P140 peptide platform and to provide
additional working capital to strengthen
the Company's Statement of Financial Position
as negotiations continue with potential partners
for Lupuzor(TM) . Following the Admission
of the shares placed, the Company has a total
of 139,467,430 ordinary shares in issue with
each share carrying the right of one vote.
On 17 April 2018, the Company announced the
initial results of the Phase III clinical
trial for Lupuzor(TM) . Lupuzor(TM) demonstrated
a superior response rate over placebo (52.5%
vs 44.6% "responders") in the primary analysis
on the Full Analysis Set of all 202 patients
(including withdrawals who are considered
non-responders). However, due to a high response
rate in the placebo group, this superior
response did not allow statistical significance
to be reached and the primary end-point was
not met. Lupuzor(TM) also demonstrated a
superior response rate over placebo (68.8%
vs 59.2%) in the 153 patients who completed
the study. Importantly in patients who had
anti-dsDNA autoantibodies (a recognised biomarker
for Systemic Lupus Erythematosus ('SLE')),
Lupuzor(TM) demonstrated a superior response
rate over placebo (61.5% vs 47.3%). In addition,
7.6% of these patients in the Lupuzor(TM)
group went into full remission versus none
in the placebo group. Importantly, the study
confirmed the outstanding safety profile
of Lupuzor(TM), with zero serious adverse
events reported.
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.
END
FR FMGZKMRRGRZZ
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