TIDMIMM
RNS Number : 9689W
Immupharma PLC
29 April 2021
ImmuPharma PLC
("ImmuPharma" or the "Company")
FINAL RESULTS ANNOUNCEMENT
for the twelve months ended 31 December 2020
ImmuPharma PLC (LSE:IMM), (Euronext Growth Brussels: ALIMM),
("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 2020 (the "Period").
Key Highlights (including post Period review)
-- Stable financial performance over the Period
o Cash balance of GBP5.9m (31 December 2019: GBP1.4m)
o Derivative financial asset of GBP1.2m (31 December 2019:
GBP2.3m)
o Incanthera financial asset of GBP1.8m (GBP0.7m at 31 December
2019) and warrants financial asset of GBP0.6m (GBPNil at 31
December 2019)
o Convertible loan notes of GBP0.6m (GBPNil at 31 December
2019)
o Loss for the period of GBP6.9m (31 December 2019: GBP6.1m)
o Research and development expenses of GBP2.4m (31 December
2019: GBP2.7m)
o Administrative expenses of GBP1.8m (31 December 2019:
GBP1.8m)
o Share based expense of GBP1.6m (31 December 2019: GBP2m)
o Finance cost of GBP1.7m (31 December 2019: GBP0.5m) due to
loss on derivative financial asset
o Basic and diluted loss per share of 3.43p (31 December 2019:
3.99p)
o GBP1.5m subscription agreement through the issue of 15,000,000
new ordinary shares - March 2020
o Funds raised from US healthcare investors of GBP2.4m/$3m (face
value) - June 2020
o US healthcare investors converted part of their loans into
equity, resulting in 7,437,226 ordinary shares issued in 2020
o Placing of new ordinary shares of GBP6.5m (gross) - September
2020
'Autoimmunity': Lupuzor(TM)
-- Licence and development agreement with Avion Pharmaceuticals progress:
o Avion has had a number of progressive discussions with the FDA
over 2020 culminating in a Type 'A' meeting on 4 December 2020
o Based on positive guidance and feedback from FDA there is now
a clear regulatory pathway to commence the Phase III trial in H2
2021
o Avion and ImmuPharma will develop and validate a bioanalytical
assay in order to confirm the unique pharmacokinetic profile of
Lupuzor(TM), prior to the commencement of the Phase III study
o Final guidance meeting between Avion and the FDA anticipated
in Q2 2021
o Discussions continue with potential partners for Lupuzor(TM)
outside of US in key territories
-- Proof of Concept study planned for Lupuzor(TM) in CIDP
patients - potential Orphan Drug designation
Other program developments through Ureka Pharma SAS
-- Three therapy areas: Anti-Infectives, Metabolism and Cancer - these programs include:
o Anti-Infective: BioAMB (Anti-Fungal) - lead optimisation
completion
o Metabolism: BioGlucagon - rescue therapy for low sugar events
in diabetes
o Cancer: Nucant, IPP-204106
o All programs provide potential future partnering
opportunities
Incanthera plc, oncology specialist where ImmuPharma retains
13.37% shareholding
-- Listed on Aquis Stock Exchange in February 2020
-- Successful study results for 'Sol', its skin cancer
technology and positive data from Sensitisation study
Audited Annual Report and Accounts
-- The Annual Report for the year ended 31 December 2020, will
today be published on the Company's website. Copies of this Report,
including the Notice of Annual General Meeting, will be posted to
shareholders in the near future. To view the Report please go to:
www.immupharma.co.uk .
Commenting on the statement and outlook Tim McCarthy, Chairman,
said: "Despite the continuing disruption of the Covid -19 pandemic,
we remain focused, in collaboration with our partner Avion, on
expediting Lupuzor(TM) into a new optimised, international Phase
III study in Lupus patients in H2 2021. The most recent positive
feedback from the FDA confirms our envisaged roadmap forward.
"In parallel, we continue to progress our other R&D programs
which includes our anti-fungal BioAMB therapy, which has the
potential of progressing quickly through initial bio-equivalence
trials. Discussions for potential partnering opportunities are
continuing. These initiatives create further opportunities in the
medium to long term.
"In response to strong investor interest last year, we were
delighted to welcome new and returning institutional and private
investors as part of three successful capital raisings. This has
created a robust financial position with an anticipated cash runway
until the end of 2023.
"As we move our key asset, Lupuzor(TM) into a new international
optimised Phase III trial and continue to progress our development
pipeline, the investment thesis of ImmuPharma continues to
strengthen and we look forward to providing further value enhancing
progress updates over the next period to create long term
shareholder value for our shareholders.
"Finally, the Board would like to take this opportunity to thank
its shareholders, new and longstanding, for their continued support
as well as its staff, corporate and scientific advisers and our
partners including, CNRS and Avion."
Market Abuse Regulation (MAR) Disclosure
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS STIPULATED
UNDER THE UK VERSION OF THE MARKET ABUSE REGULATION NO 596/2014
WHICH IS PART OF ENGLISH LAW BY VIRTUE OF THE EUROPEAN (WITHDRAWAL)
ACT 2018, AS AMED. ON PUBLICATION OF THIS ANNOUNCEMENT VIA A
REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO
BE IN THE PUBLIC DOMAIN.
For further information please contact:
ImmuPharma PLC ( www.immupharma.com )
Tim McCarthy, Chairman + 44 (0) 207 152 4080
Dimitri Dimitriou, Chief Executive Officer
Lisa Baderoon, Head of Investor Relations + 44 (0) 7721 413496
SPARK Advisory Partners Limited (NOMAD)
Neil Baldwin
Stanford Capital Partners (Joint Broker)
Patrick Claridge, John Howes +44 (0) 203 36 8 8974
SI Capital (Joint Broker) +44 (0) 203 815 8880
Nick Emerson +44 (0) 1483 413500
4Reliance (Euronext Growth Listing Sponsor)
Jean-Charles Snoy
Degroof Petercam (Liquidity Provider)
Erik De Clippel
+32 (0) 2 747 02 60
Backstage Communication +32 (0) 2 287 95 34
Olivier Duquaine +32 (0) 477 504 784
Gunther De Backer +32 (0) 475 903 909
ImmuPharma plc
Chairman's Report
The first half of 2020 saw a number of key developments for
ImmuPharma, despite the disruptions caused by the Covid-19 global
pandemic. These included progress within our flagship Lupuzor(TM)
program, expansion of the R&D pipeline, particularly within our
peptide platform technologies and securing strategic
investments.
During the second half of 2020, ImmuPharma successfully raised,
in response to investor demand, additional funding of GBP6.5m
(gross), bringing the total funds raised for the year to GBP10.2m
(gross). Additionally, ImmuPharma obtained further clarity
regarding the Phase III clinical trial for Lupuzor(TM), working
alongside its partner, Avion Pharmaceuticals. In parallel, outside
of the US, ImmuPharma continued to explore opportunities with other
potential commercial partners for Lupuzor(TM) and also within the
Company's extended pipeline.
Lupuzor(TM) - Opportunity and next steps
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 efficacy, with over 60 per cent of
patients not adequately treated.
ImmuPharma believes Lupuzor(TM) has the potential to be a novel
specific 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.
The Board is confident that there are a number of routes to
market for Lupuzor(TM), including corporate collaborations. Such a
collaboration was successfully completed at the end of November
2019, resulting in a signed exclusive Trademark, License and
Development Agreement with Avion Pharmaceuticals LLC ("Avion") in
the US. Positive discussions with a number of potential commercial
partners for Lupuzor(TM) in key territories outside of the US are
continuing.
Lupuzor(TM) and Avion Pharmaceuticals
On 28 November 2019, ImmuPharma and Avion Pharmaceuticals
("Avion") signed an exclusive Trademark, License and Development
Agreement for Lupuzor(TM), with Avion agreeing to fund a new
international Phase III trial and commercialising Lupuzor(TM) in
the US. Since then, both companies have been working closely on the
clinical trial design and strategy, bolstered by consultation with
an eminent group of key opinion leaders. This tripartite Phase III
protocol development approach provided thorough and detailed
support for developing the most relevant clinical trial for
Lupuzor(TM) in systemic lupus erythematosus ("SLE") patients. Data
and results from the first Phase III clinical study were analysed
and considered in detail and, as a result, a new optimised
international Phase III study protocol has been finalised.
Regulatory progress was announced in November 2020, whereby the
FDA offered to accept submission for a Type 'A' Meeting Request,
following which Avion submitted a full dossier on 6 November 2020
through the FDA Type 'A' route.
On 9 February 2021 ImmuPharma provided a progress update to the
market in respect to the feedback post the 'Type A' meeting between
the FDA and Avion. Based on the positive guidance and feedback from
FDA, it was confirmed that there is now a clear regulatory pathway
to commence the Phase III trial in H2 2021, fully funded by Avion,
estimated to be around $25 million investment. As part of this
feedback, Avion and ImmuPharma will develop and validate a
bioanalytical assay in order to confirm the unique pharmacokinetic
profile of Lupuzor(TM), prior to the commencement of the Phase III
study. This will be presented at the final guidance meeting between
Avion and the FDA currently scheduled for Q2 2021 as well as
confirming the previously submitted data on study design, clinical
end points and the pathway to approval.
ImmuPharma plc
Chairman's Report (continued)
Meanwhile, ImmuPharma has initiated the production of a new
batch of Lupuzor(TM) clinical trial material specifically for the
Phase III trial and it can be confirmed that this will be ready for
the start of the trial.
Centre National de la Recherche Scientifique (CNRS)
ImmuPharma continues to have important collaboration
arrangements with the Centre National de la Recherche Scientifique
("CNRS"), the French National Council for Scientific Research and
the largest basic research organisation in Europe. This is where
Lupuzor(TM) was invented by Prof. Sylviane Muller, former Research
Director at the CNRS. Through this partnership, the CNRS will be
entitled to receive from ImmuPharma, low double-digit royalty
payments of funds received by ImmuPharma from Avion through the
Licence and Development Agreement.
Pipeline Overview
ImmuPharma's pipeline includes novel peptide-based therapeutics
within four therapy areas: Autoimmunity; Anti-Infectives;
Metabolism and Cancer.
Autoimmunity / Lupuzor(TM) / Forigerimod / P140 Platform
Lupuzor(TM) , is also known by its chemical name 'Forigerimod'
or 'P140'. Outside of Lupuzor(TM) for lupus, ImmuPharma is
exploring opportunities of expanding into other autoimmune
indications that are directly linked to Lupuzor's(TM) ' unique
mechanism of action, chaperone mediated autophagy (CMA). The first
example of CMA action has been demonstrated in lupus with an
excellent safety profile.
Certain autoimmune indications, outside of lupus, have the
potential for Orphan Drug designation. One disease of key interest
to ImmuPharma's team is Chronic Inflammatory Demyelinating
Polyneuropathy ("CIDP"). CIDP is a neurological disorder targeting
the body's nerves. Further assessment continues with the objective
of moving CIDP forward into a Proof of Concept study, based on the
strong data already gained within ImmuPharma's lupus dossier.
Elro and Ureka combined to form Ureka Pharma SAS
On 1 January 2020, the Company combined its two subsidiaries,
Ureka Pharma SAS ('Ureka') and Elro Pharma SARL ('Elro') into one
entity Ureka Pharma SAS ("Ureka Pharma"). The intention was to
maximise value from the combined entity through scale and
synergies, whilst retaining an interest in any future commercial
success. There are three therapy areas within Ureka:
Anti-Infectives, Metabolism and Cancer.
Anti-Infectives
ImmuPharma has started exploring opportunities in research and
development of anti-fungal and anti-viral programs.
Within anti-fungal, ImmuPharma has developed BioAMB, a novel
peptide-based drug that offers a potential improvement on
Amphotericin-B ("AMB"). AMB is one of the few effective treatments
for many serious and life-threatening fungal infections
(aspergillosis) caused by the aspergillus family of fungi.
Although highly effective against aspergillus, the existing AMB
products are reserved for use after the azole (synthetic) class of
drugs due to their poor safety and tolerability profile. The
leading AMB, 'Ambisome' is known to cause serious kidney toxicity
in 14-15% of patients. ImmuPharma's BioAMB target profile is to
achieve a superior safety and tolerability profile compared to
Ambisome.
Sales of Ambisome in 2020 were $436 million. The next step for
ImmuPharma is to progress the lead optimised candidate through the
relevant pre-clinical safety and efficacy studies in animals in
comparison to existing AMB products. Following this, there is
potential to go immediately into a bioequivalence study in humans
and submission for marketing approval. Discussions for potential
partnering opportunities continue.
ImmuPharma plc
Chairman's Report (continued)
Within anti-viral, we have been investigating the application of
the Ureka peptide technologies, which suggests the potential to
create effective anti-fusion peptides with the goal to prevent
virus entry into the host cells, which may lead to novel peptide
based anti-viral therapies. Further exploratory work continues on
this program.
Metabolism | 'BioGlucagon'
BioGlucagon, is a potential new rescue therapy for low sugar
events in diabetes. Existing glucagon products have poor solubility
and are inconvenient with variable dosing due to poor solubility
creating risks for patients. BioGlucagon has 100% solubility, can
be formulated in pre-filled syringe pens and could be used in
insulin pumps. The next step is opening up partnering
discussions.
Metabolism & Urelix(TM) technology
This therapy area has been developing lead compounds from its
novel and patented peptide technology platform Urelix(TM) . The
laboratories are based at the Institut Europeen de Chimie et
Biologie (IECB) in Bordeaux, France, which is under the joint
authority of the CNRS, Inserm and the University of Bordeaux.
Urelix(TM) is focusing on oligourea foldamers as a tool to
improve the pharmaceutical properties of peptides. One of the first
focus areas has been GLP-1 analogues for the treatment of Type II
diabetes and NASH (Non- Alcoholic-Steato-Hepatitis) as proof of
concept for its technology. This proof of technical capability was
published in Nature Communications in 2019.
Further applications of the Urelix(TM) technology include
protein/protein interactions, notably in cancer, and improvement of
marketed efficacious peptides allowing additional long lasting
patent protection, paving the way for a life cycle management
franchise.
Cancer
ImmuPharma's Nucant cancer program, IPP-204106, is focused on
combination cancer therapy approaches. The molecule has also shown
promising results in ophthalmology (age-related macular
degeneration) models. Partnering discussions will be explored.
Capital Subscription
On 30 March 2020 ImmuPharma announced subscriptions to raise
GBP1.5 million (the "Subscriptions") through the issue of
15,000,000 new ordinary shares of 10 pence each in ImmuPharma
("Ordinary Shares") (the "Subscription Shares") at a price of 10p
per Ordinary Share ("Issue Price").
The Subscriptions comprised a GBP200,000 subscription from Dr
Robert Zimmer, (Director, President & Chief Scientific Officer
of ImmuPharma) through Luca and Associates AG ("Luca") ( a company
to which he is connected) and a further GBP1.3 million subscription
with Lanstead Capital Investors LP ("Lanstead"), an institutional
investor and substantial shareholder, together with a related
Sharing Agreement, to raise in aggregate GBP1.5 million before
expenses.
The GBP1.3 million gross proceeds of the Lanstead subscription
was followed by the sharing agreement with Lanstead (the "Sharing
Agreement") for 100% of these shares with a reference price of
13.33p per share. The Sharing Agreement is for a 24 month period.
The actual consideration is variable depending upon ImmuPharma's
share price and provides the opportunity for ImmuPharma to benefit
from a positive future share price performance.
The Company also agreed to issue Lanstead 650,000 ordinary
shares in connection with entering into the Sharing Agreement.
The new subscription from Lanstead followed the GBP2.66 million
investment from Lanstead secured in June 2019.
ImmuPharma plc
Chairman's Report (continued)
On 8 September 2020, as a consequence of the convertible
security deeds and option deeds with L1 Capital Global
Opportunities Master Fund ("L1") and Lind Global Macro Fund LP
("Lind"), the benchmark price referred to in the two Lanstead
sharing agreements has increased from 13.33p to 20p. The varied
benchmark price of 20p applied to 13 monthly settlements remaining
under the sharing agreement dated 26 June 2019 and 22 monthly
settlements under the sharing agreement dated 30 March 2020.
Investment from US healthcare investors
On 10 June 2020 ImmuPharma entered into agreements with two
specialist US healthcare investors for a total investment of up to
$6.30 million (GBP4.94 million) comprising an issue of unsecured
convertible securities ("Securities") and associated options to
purchase shares in ImmuPharma Plc in the future. ImmuPharma issued
$3 million (GBP2.35 million) in face value of Securities to L1 and
Lind, managed by The Lind Partners, LLC ("the Investors") with a
maturity period of 18 months. The Securities were issued for the
gross proceeds of $2.7 million (GBP2.15 million).
According to the agreement, at any time, during the maturity
period, the Investors may convert their Securities (in whole or in
part) to 13,086,619 ordinary shares in the Company, in aggregate,
at a price of 17.96p ("Conversion Price"), which is equivalent to
120% of the Volume Weighted Average Price ("VWAP") of the ordinary
shares for 9 June 2020. During the maturity period, the Company may
require the investors to convert their securities to ordinary
shares, if the VWAP on each of at least 20 consecutive trading days
shall be equal to or have exceeded 35.92p (200% of the Conversion
Price).
Should ImmuPharma raise additional funds, the Investors may
require the Company to repurchase any unconverted Securities, to
the value of up to 25% of the gross proceeds of the financing, at
105% of face value.
Should any securities remain unconverted on 10 December 2021 the
Company will repurchase, from the Investors, the outstanding face
value of the unconverted Securities.
In addition, the Investors have been granted 15,703,942 Options
in the Company, which may be exercised at any time up to 3 years,
with an exercise price the same as the Conversion Price, which, if
all exercised, would amount to $3.60 million (GBP2.82 million).
On 2 September 2020, as a consequence of the placement of new
ordinary shares of GBP6.5 million (before expenses), pursuant to
the terms of the convertible security deeds ("CSD") dated 10 June
2020 with each of Lind and L1: (i) the conversion price stated in
the CSD (previously 17.96p) has been adjusted downwards to the
placing price of 11p, meaning that, upon conversion in full of the
CSD, 21,369,354 new ordinary shares (subject to adjustment at the
time of conversion by reference to the sterling - US dollar
exchange rate at the time) would be issued in aggregate to L1 and
Lind (compared to 13,086,619 previously); and (ii) under the terms
of the option deeds, both the option exercise price and the number
of shares subject to the options will vary. In aggregate, following
the placing, 25,640,254 ordinary shares (compared to 15,703,942
previously) will be subject to the option deeds at an option
exercise price of 11p per share.
On 3 September 2020 L1 converted in total $150,000 (plus accrued
but unpaid interest) of the convertible security. The conversion
price was 11p per share resulting in the issue by the Company of
1,045,046 new ordinary shares of 10p each in the Company.
On 9 September 2020 L1 converted in total $200,000 (plus accrued
but unpaid interest) of the convertible security. The conversion
price was 11p per share resulting in the issue by the Company of
1,429,938 new ordinary shares of 10p each in the Company.
On 10 September 2020, Lind Global Macro Fund, LP converted
$150,000 of the convertible security issued pursuant to the
convertible security deed dated 10 June 2020. The conversion price
is 11p per share resulting in the issue by the Company of 1,026,750
new ordinary shares of 10p each in the Company.
ImmuPharma plc
Chairman's Report (continued)
On 22 September 2020, following the share placing by ImmuPharma
plc on 2 September 2020, in accordance with the terms of the
convertible security deed, Lind has requested repayment of part of
its convertible security. The amount repaid amounted to
$1,068,762.
On 23 November 2020, L1 converted in total $200,000 (plus
accrued but unpaid interest) of the convertible security. The
conversion price was 11p per share resulting in the issue by the
Company of 1,430,510 new ordinary shares of 10p each in the
Company.
On 24 November 2020, Lind converted in total $355,112.50 (plus
accrued but unpaid interest) of the convertible security. The
conversion price was 11p per share resulting in the issue by the
Company of 2,504,982 new ordinary shares of 10p each in the
Company. All of the convertible security issued to Lind has now
been repaid or converted.
Placement of GBP6.5m
On 2 September 2020 the Company announced that due to investor
demand, it had successfully raised GBP6.5 million, (before
expenses) via an oversubscribed placing of 59,090,909 new ordinary
shares of 10p each in the Company at a price of 11p per share.
Interest in Incanthera plc
In September 2018, ImmuPharma signed a Heads of Terms agreement
with Incanthera Ltd ("Incanthera") regarding a potential
collaboration on the Nucant program. Discussions were ultimately
terminated.
At the same time, ImmuPharma invested GBP2 million to purchase
363,637 shares at GBP5.50 per share in Incanthera and received
warrants for a further 363,637 shares at GBP5.50. This investment
represented a holding of approximately 15% in Incanthera in
2018.
On 26 February 2020 Incanthera entered into a Share Exchange
Agreement with its shareholders, whereby each shareholder in
Incanthera agreed to exchange their original shares for shares in
the new Company - Incanthera Plc, resulting in the allotment of
48,564,280 ordinary shares.
On 28 February 2020, Incanthera's shares were admitted to
trading on Aquis Stock Exchange ("AQSE", formerly NEX Exchange)
under the ticker (TIDM: INC). Following Admission to trading,
ImmuPharma retained 7,272,740 (from 363,637 held previously,
subject of 1:20 sub-division) ordinary shares in Incanthera,
representing 15% of Incanthera's enlarged issued ordinary share
capital.
ImmuPharma also has 7,272,740 warrants options in Incanthera plc
at an exercise price of 9.5p pence, being the price at which new
shares have been issued in the Placing accompanying Incanthera's
listing ("Issue Price").
In addition, ImmuPharma entered into a Subscription Agreement
with Incanthera. Under the Subscription Agreement, ImmuPharma
subscribed GBP250,000 for 2,631,579 new Ordinary Shares in
Incanthera. Following the execution of the subscription, announced
on 29 September 2020, ImmuPharma held 9,904,319, new Ordinary
Shares, equating to 15.35% of Incanthera's enlarged share capital
of 64,544,121 ordinary shares.
On the 23 March 2021 Incanthera raised GBP1,144,650 through the
issue of 9,538,750 new placing shares. As a result, ImmuPharma's
shareholding in Incanthera currently stands at 13.37%. As a major
shareholder ImmuPharma remains supportive of Incanthera and its
diverse oncology pipeline.
Incanthera recently announced that a new refined formulation of
Sol, its lead product for skin cancer and other topical
indications, demonstrated statistically significant greater dermal
delivery compared with four known oral delivery comparator
products.
ImmuPharma plc
Chairman's Report (continued)
Grant of Share Options and Warrants
On 25 November 2020, ImmuPharma approved the grant of options
over a total of 9,625,000 ordinary shares of 10p each in the
Company ("Ordinary Shares") to Directors, employees and consultants
representing 3.8% of ImmuPharma's Ordinary Shares and total voting
rights.
Upon the recommendation of the Company's remuneration committee,
the Company has granted the Options pursuant to the Company's Share
Option Plan which was adopted on 30 March 2017.
The exercise price for the Options is 20p being a 54% premium to
the closing middle market share price of 13p on 25 November 2020.
The Options will vest after three years and are exercisable between
three and ten years from the date of grant.
On 30 March 2020, in connection with its services in relation to
the Lanstead subscription, the Company has issued warrants over
915,205 Ordinary Shares with an exercise price of 10 pence per
share to Stanford Capital Partners Limited ("SCP"), the Company's
broker. These warrants have an exercise period of 10 years.
On 2 September 2020, in connection to the services related to
GBP6.5m placing, each of Company's brokers; SCP and SI Capital
Limited ("SI") received warrants over 1,213,920 of ImmuPharma's
Ordinary Shares with an exercise price of 11p per share. These
warrants have an exercise period of 10 years.
Current Activities and Outlook
Despite the continuing disruption of the Covid -19 pandemic, we
remain focused, (in collaboration with our partner Avion) on
expediting Lupuzor(TM) into a new optimised, international Phase
III study in Lupus patients in H2 2021. The most recent positive
feedback from the FDA confirms our envisaged roadmap forward.
In parallel, we continue to progress our other R&D programs
which includes our anti-fungal BioAMB therapy, which has the
potential of progressing quickly through initial bio-equivalence
trials. Discussions for potential partnering opportunities are
continuing. These initiatives create further opportunities in the
medium to long term.
In response to strong investor interest last year, we were
delighted to welcome new and returning institutional and private
investors as part of three successful capital raisings. This has
created a robust financial position with an anticipated cash runway
until the end of 2023.
As we move our key asset, Lupuzor(TM) into a new international
optimised Phase III trial and continue to progress our development
pipeline, the investment thesis of ImmuPharma continues to
strengthen and we look forward to providing further value enhancing
progress updates over the next period to create long term
shareholder value for our shareholders.
Finally, the Board would like to take this opportunity to thank
its shareholders, new and longstanding, for their continued support
as well as its staff, corporate and scientific advisers and our
partners including CNRS and Avion.
Tim McCarthy
Non-Executive Chairman
ImmuPharma plc
Financial Review
The financial results of the ImmuPharma Group in this report
cover the year ended 31 December 2020. The Group principal activity
is that of research and development of novel drugs to treat serious
medical conditions.
Income Statement
The operating loss for the year ended 31 December 2020 was
GBP5.6 million, down from GBP6.3 million for the year ended 31
December 2019. The research and development expenditure was GBP2.4
million, down from GBP2.7 million in 2019. Covid-19 disruption to
laboratory work was the main reason for this reduction.
Administrative expenses were GBP1.8 million (2019: GBP1.8 million).
The total fair value gain of GBP1.5 million (2019: fair value loss
of GBP1.3 million) comprises of the following components: fair
value gain on Incanthera's shares of GBP852k (2019: fair value loss
of GBP1,309k) and fair value gain on Incanthera's warrants of
GBP626k (2019: GBPnil). This has been charged to Statement of
Comprehensive Income. Finance income has decreased from GBP64k in
2019 to GBP41k in 2020. Finance costs amounted to GBP1.7 million,
up from GBP527k in 2019, caused largely by the loss on the Lanstead
derivative financial asset. Total comprehensive loss for the year
was GBP5.3 million, a decrease from GBP7.0 million in 2019.
Statement of Financial Position
The Group cash and cash equivalents at 31 December 2020 amounted
to GBP5.9 million with the increase related to successful
fundraising activities in 2020 (2019: GBP1.4 million). The
convertible loan notes amounted to GBP635k (2019: GBPnil),
following the issue of two convertible loans as discussed on pages
5-6. The total value of the financial asset equated to GBP2.4
million, comprising of shares in Incanthera of GBP1.8 million
(2019: GBP0.7 million) and warrants in Incanthera of GBP0.6 million
(2019: GBPnil). At 31 December 2020 the Lanstead derivative
financial asset amounted to GBP1.2 million (2019: GBP2.3 million).
The decrease was caused by the increase to the share benchmark
price from 13.33p to 20p and only 9 months remaining of the June
2019 Lanstead ("the Sharing Agreement") term.
Results
The Group recorded a loss for the year of GBP6.9 million (2019:
GBP6.1 million). Basic and diluted loss per share was 3.43p (2019:
3.99p). In accordance with the Group's loss making position, no
dividend is proposed.
Total Voting Rights
The Company had a total of 250,221,297 ordinary shares in issue
at 31 December 2020 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.
On behalf of the Board
Dimitri Dimitriou
Director
ImmuPharma plc
CONSOLIDATED INCOME STATEMENT
FOR THE YEARED 31 DECEMBER 2020
Year ended Year ended
Notes 31 December 31 December
2020 2019
GBP GBP
Continuing operations
Revenue 126,667 77,925
Other operating income - 119,901
Research and development
expenses (2,372,834) (2,664,550)
Administrative expenses (1,764,897) (1,831,395)
Share based expense (1,578,368) (1,983,525)
Operating loss (5,589,432) (6,281,644)
Finance costs (1,697,832) (526,734)
Finance income 41,089 64,014
Loss before taxation (7,246,175) (6,744,364)
Tax 386,248 620,774
Loss for the year (6,859,927) (6,123,590)
Attributable to:
Equity holders of the parent
company (6,859,927) (6,123,590)
Loss per ordinary share
Basic and diluted 2 (3.43)p (3.99)p
ImmuPharma plc
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE YEARED 31 DECEMBER 2020
Year Year
ended 31 ended 31
December December
2020 2019
GBP GBP
Loss for the financial period (6,859,927) (6,123,590)
Other comprehensive income
Items that will not be reclassified
subsequently to profit or loss:
Fair value gain/(loss) on investment 851,772 (1,309,090)
Fair value gain on warrants 625,576 -
Total items that will not be reclassified
subsequently to profit or loss 1,477,348 (1,309,090)
Items that may be reclassified
subsequently to profit or loss:
Exchange differences on translation
of foreign operations 42,207 438,810
Total items that may be reclassified
subsequently to profit or loss 42,207 438,810
Other comprehensive income/(loss)
for the period 1,519,555 (870,280)
Total comprehensive loss for the
period (5,340,372) (6,993,870)
ImmuPharma plc
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 31 DECEMBER 2020
31 December 31 December
2020 2019
GBP GBP
Non-current assets
Intangible assets 484,042 478,960
Property, plant and equipment 411,606 206,744
Derivative financial asset 174,488 843,147
Financial assets 2,418,258 690,910
Total non-current assets 3,488,394 2,219,761
Current assets
Trade and other receivables 161,998 153,609
Derivative financial asset 1,016,635 1,456,714
Cash and cash equivalents 5,862,057 1,364,840
Current tax asset 386,590 606,157
Total current assets 7,427,280 3,581,320
Current liabilities
Financial liabilities - borrowings (6,939) (26,778)
Trade and other payables (619,037) (505,089)
Convertible loan notes (634,902) -
Total current liabilities (1,260,878) (531,867)
Net current assets 6,166,402 3,049,453
Net assets 9,654,796 5,269,214
EQUITY
Ordinary shares 25,022,130 16,736,093
Share premium 27,237,329 27,187,316
Merger reserve 106,148 106,148
Other reserves 3,255,536 1,430,337
Retained earnings (45,966,347) (40,190,680)
Total equity 9,654,796 5,269,214
The financial statements were approved by the Board of Directors
and authorised for issue on 28 April 2021
They were signed on its behalf by:
Robert Zimmer Dimitri Dimitriou
Director Director
ImmuPharma plc
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE YEARED 31 DECEMBER 2020
Other
Merger Other Other reserves Other
reserve reserves reserves - Equity reserves Retained
- - shares - Convertible earnings
Share Share Acquisition Translation to be option Total
capital premium reserve reserve issued reserve equity
GBP GBP GBP GBP GBP GBP GBP GBP GBP
At 1 January
2019 13,946,744 27,320,145 106,148 (3,541,203) (1,789,497) 4,338,702 - (32,758,000) 7,623,039
Loss for the
financial
year - - - - - - - (6,123,590) (6,123,590)
Exchange
differences
on
translation
of foreign
operation - - - - 438,840 - - - 438,810
Transactions
with owners:
Share based
payments - - - - - 1,983,525 - - 1,983,525
New issue of
equity
capital 2,789,349 - - - - - - - 2,789,349
Costs of new
issue
of equity
capital - (132,829) - - - - - - (132,829)
Fair value
loss on
investments - - - - - - - (1,309,090) (1,309,090)
At 31
December
2019 16,736,093 27,187,316 106,148 (3,541,203) (1,350,687) 6,322,227 - (40,190,680) 5,269,214
Loss for the
financial
year - - - - - - - (6,859,927) (6,859,927)
Exchange
differences
on
translation
of foreign
operations - - - - 42,207 - - - 42,207
Transactions
with owners:
Share based
payments - - - - - 1,751,369 - - 1,751,369
Equity
component of
convertible
loan notes - - - - - - 31,623 - 31,623
New issue of
equity
capital 8,286,037 665,281 - - - - - - 8,951,318
Costs of new
issue
of equity
capital - (615,268) - - - - - (393,088) (1,008,356)
Fair value
gain on
investments - - - - - - - 851,772 851,772
Fair value
gain on
share
warrants - - - - - - - 625,576 625,576
At 31
December
2020 25,022,130 27,237,329 106,148 (3,541,203) (1,308,480) 8,073,596 31,623 (45,966,347) 9,654,796
Attributable
to:-
Equity
holders of
the
parent
company 25,022,130 27,237,329 106,148 (3,541,203) (1,308,480) 8,073,596 31,623 (45,966,347) 9,654,796
ImmuPharma plc
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE YEARED 31 DECEMBER 2020
Notes Year ended Year ended
31 December 31 December
2020 2019
GBP GBP
Cash flows from operating
activities
Cash used in operations 3 (3,879,936) (4,963,710)
Tax received 606,157 746,369
Interest paid (55,622) (4,045)
Net cash used in operating activities (3,329,401) (4,221,386)
Investing activities
Purchase of property, plant
and equipment (360,290) (107,111)
Interest received 41,089 5,743
Purchase of investments (250,000) -
Net cash used in investing activities (569,201) (101,368)
Financing activities
Decrease in bank overdraft (184) (14)
Loan repayments (21,256) (89,205)
Settlements from Sharing Agreement 1,292,393 414,930
Gross proceeds from issue
of new share capital 8,000,000 2,656,520
Share capital issue costs (702,133) -
Funds deferred per Sharing
Agreement (1,300,000) (2,656,520)
Gross proceeds from issue 2,152,252 -
of convertible loan notes
Convertible loan notes issue (235,552) -
costs
Convertible loan notes repaid (815,166) -
Net cash generated from financing
activities 8,370,354 325,711
Net increase/(decrease) in cash
and cash equivalents 4,471,752 (3,997,043)
Cash and cash equivalents
at beginning of year 1,364,840 4,911,448
Effects of exchange rates on
cash and cash equivalents 25,465 450,435
Cash and cash equivalents
at end of year 5,862,057 1,364,840
ImmuPharma plc
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 2020 or 31 December 2019.
The financial information has been extracted from the statutory
accounts for the years ended 31 December 2020 and 31 December
2019. 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 2020 and 31 December
2019. For the year ended 31 December 2020 it did include
an emphasis of matter paragraph relating to the carrying
value of Parent Company's investment in subsidiaries and
receivables due from group undertakings. For the year ended
31 December 2019, it did include an emphasis of matter paragraphs
relating to going concern and the carrying value of Parent
Company's investment in subsidiaries and receivables due
from group undertakings. The Group's statutory accounts
for the year ended 31 December 2019 have been delivered
to the Registrar of Companies, whereas those for the year
ended 31 December 2020 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 statutory accounts for the year
ended 31 December 2019 and interim results for the period
ended 30 June 2020, which have been prepared in accordance
with International Financial Reporting Standards ('IFRS').
The financial information is for the year ended 31 December
2020 and the comparatives are for the year ended 31 December
2019.
The Group's statutory accounts incorporate the financial
statements of ImmuPharma plc and other entities controlled
by the company ("the subsidiaries"). The control principle
in IFRS 10 sets out the following three elements of control:
power over the investee; exposure, or rights, to variable
returns from involvement with the investee; and. the ability
to use power over the investee to affect the amount of those
returns. The financial statements of these other entities
cease to be included in the Group financial statements from
the date that control ceases.
ImmuPharma plc
2 LOSS PER SHARE Year ended Year ended
- Group 31 December 31 December
2020 2019
GBP GBP
Loss
Loss for the purposes of basic loss
per share being net loss after tax
attributable to equity shareholders (6,859,927) (6,123,590)
Number of shares
Weighted average number of ordinary
shares for the purposes of basic earnings
per share 200,176,156 153,452,385
Basic loss per share (3.43)p (3.99)p
Diluted loss per share (3.43)p (3.99)p
There is no difference between basic loss per share and diluted
loss per share as the share options and warrants are anti-dilutive.
ImmuPharma plc
3 CASH USED IN OPERATIONS
Group Group
31 December 31 December
2020 2019
GBP GBP
Operating loss (5,589,432) (6,281,644)
Depreciation and
amortisation 170,954 88,038
Share-based payments 1,578,368 1,983,525
(Increase)/decrease
in trade and other
receivables (8,380) 177,878
Increase/(decrease)
in trade and other
payables 113,926 (408,818)
(Gain)/loss on foreign
exchange (145,372) (522,689)
Cash used in operations (3,879,936) (4,963,710)
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