REG - Immupharma PLC - Final Results
05/06/2024 07:00
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RNS Number : 1157R Immupharma PLC 05 June 2024
RNS: | 5 June 2024
ImmuPharma PLC
("ImmuPharma" or the "Company")
FINAL RESULTS
for the twelve months ended 31 December 2023
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 2023 (the "Period").
Key Highlights (including post Period review)
Financials
· Loss for the Period of £2.9m (2022: £3.8m)
· Research and development expenses of £2.0m (2022: £2.0m)
· Administrative expenses of £1.0m (2022: £0.8m)
· Share based expense of £0.14m (2022: £0.16m)
· Cash balance of £0.2m at 31 December 2023 (31 December 2022:
£0.7m)
· Lanstead derivative financial asset of £0.6m (2022: £0.3m)
· Basic and diluted loss per share of 0.81p ( 2022: 1.26p)
· Incanthera financial asset: shares of £0.6m (2022: £0.7m) -
warrants of £1 (2022: £1k)
· Fundraising in September 2023, comprising gross proceeds of £130,683
in addition to £1.35 million being raised in a Subscription and Direct
Subscription
Portfolio
SLE/Lupus
· A Phase 3 dose-range study of P140, rather than a Phase 2/3
adaptive study, is the preferred design.
· Importantly, the direct Phase 3 route is faster to filing for
approval whilst also incorporating the FDA's request for demonstration of a
dose-ranging in the pivotal program
· The international SLE Phase 3 dose-range study design and
protocol is substantially different from the previous Phase 3 clinical trial
completed by ImmuPharma in 2018
· Dosing will be significantly higher and subcutaneous injection,
once a month, will be administered with a highly convenient and patient
friendly autoinjector. The doses are safe and well tolerated.
· Two planned interim analyses during the study will allow early
detection of the effectiveness of P140
· Simbec-Orion appointed as the Contract Research Organisation
("CRO")
CIDP
· In May 2023, ImmuPharma received positive guidance from FDA
following the PIND meeting that confirms the route for a Phase 2/3 adaptive
clinical study of P140 in CIDP
· This will be the first pivotal stage study of P140 in patients
with CIDP: a rare neurological disease with high medical need
· An IND application is now close to submission to the FDA,
incorporating all guidance points
· An application for Orphan Drug status for CIDP will be also
submitted in parallel
· Simbec-Orion, has been appointed as the CRO for this program
P140 technology platform
· Recent further insights into P140's mechanism of action ("MOA")
confirms its position as the only non-immunosuppressing molecule in clinical
development in the industry
· The favourable impact of P140 on immune system homeostasis also
support P140 as a new potential standard of care not only for SLE sufferers,
but for patients suffering from a multitude of autoimmune diseases that are
caused by the same underlying malfunction
· In April 2024, the Company announced that it has initiated a new
intellectual property strategy to significantly enhance the patent life and
commercial value for its P140 technology platform
Anti-infectives | Bio-AMB
· After multiple in vivo studies assessing the
Pharmacokinetic/Pharmacodynamic ("PK/PD") and safety profile of BioAMB, the
dose-effect relationship has now been assessed in Part 1 of a new dose-range
pharmacodynamic study in an aspergillosis rat model. Part 1 has now been
completed - no toxicity related to BioAMB was observed at the active dose
· Part 2 of the study will further evaluate the safety of BioAMB at
the active dose and confirm the advantage of BioAMB over the other forms of
AMB
Cancer
· In March 2023 a collaboration with Orano SA on ImmuPharma's
peptide technology was established
Partnering
· Active discussions are ongoing with new potential corporate
partners across the P140 platform and anti-infective programs.
Corporate
· In August 2023, the Board was strengthened with two NED
appointments: Dr Laurence Reilly & Dr Sébastien Goudreau
Incanthera
· On 3 June 2024 the Company sold its investment in shares in
Incanthera plc. All of the 9,904,319 shares held at the year end were sold at
15p per share realising gross proceeds of £1.4 million. ImmuPharma continues
to hold 7,272,740 warrants in Incanthera plc.
Commenting on the statement and outlook Tim McCarthy, CEO and Chairman, said:
"As a Board, we remain focused on the development of our two key late stage
clinical assets, P140 (SLE) and P140 (CIDP), and on securing additional
partnering deals for each. .We have made significant scientific progress over
the last year, including further refinement of the protocol for the P140
(SLE) study and new insights into the MOA of P140, and as a result, we have
a high level of confidence of the success of the new study.
We look forward to providing further updates on the progress of this study,
together with progress on P140 (CIDP) and our earlier stage programs
throughout 2024.
We will also continue to concentrate on further commercial and partnering
opportunities. In conjunction with the above objectives, we continue to take
prudent measures on managing our cost base.
In closing, we would like to thank our shareholders for their support as well
as our staff, corporate and scientific advisers and our partners including
CNRS and Avion."
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS STIPULATED UNDER THE UK
VERSION OF THE MARKET ABUSE REGULATION NO 596/2014 WHICH IS PART OF UK LAW BY
VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018, AS AMENDED. 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.co.uk)
Tim McCarthy, Chief Executive Officer and Chairman
Lisa Baderoon, Head of Investor Relations + 44 (0) 7721 413496
SPARK Advisory Partners Limited (NOMAD) +44 (0) 203 368 8974 (tel:0113%20370%208974)
Neil Baldwin
Stanford Capital Partners (Joint Broker) +44 (0) 203 650 3650
Patrick Claridge, Bob Pountney
SI Capital (Joint Broker) +44 (0) 1483 413500
Nick Emerson
A copy of the interim report is available on the Company's website
www.immupharma.co.uk
A copy of the interim report is available on the Company's website
www.immupharma.co.uk
Chairman's Report
The first part of 2023 was a period of further progress for ImmuPharma, as we
continued to focus on progressing our late-stage pipeline assets specifically,
within our P140 autoimmune technology platform. The end of 2023 culminated in
a significant update which centred on progressing the systemic lupus
erythematosus ("SLE") international Phase 3 study. It was confirmed that
Simbec-Orion has been appointed as the Contract Research Organisation ("CRO")
to carry out the study, following extensive due-diligence and a six-month
tender process, involving three different CROs.
In addition, a Phase 3 dose-range study, rather than a Phase 2/3 adaptive
study, is the preferred design. Importantly, the direct Phase 3 route is
faster to filing for approval whilst also incorporating the Food and Drug
Administration (FDA's) request for demonstration of a dose-ranging in the
pivotal program.
The international SLE Phase 3 dose-range study design and protocol is
substantially different from the previous Phase 3 clinical trials completed by
ImmuPharma in 2018. Dosing will be significantly higher and subcutaneous
injection, once a month, will be administered with a highly convenient and
patient friendly autoinjector. The doses are safe and well. Two planned
interim analyses during the study will allow early detection of the
effectiveness of P140.
Recent further insights into P140's mechanism of action ("MOA") confirms its
position as the only non-immunosuppressing molecule in clinical development in
the industry. The favourable impact of P140 on immune system homeostasis also
support P140 as a new potential standard of care not only for SLE sufferers,
but for patients suffering from a multitude of autoimmune diseases that are
caused by the same underlying malfunction. This also agrees with many
preclinical animal models of autoimmune diseases where P140 has clearly
demonstrated efficacy.
Positive progress with P140 was also announced in May 2023 for another
autoimmune disease with high medical need disease, chronic idiopathic
demyelinating polyneuropathy ("CIDP"). The Company received positive feedback
from the Food and Drug Administration (FDA) at a Pre-Investigational New Drug
Application (pre-IND) meeting for a late-stage Phase 2/3 adaptive clinical
program. CIDP is a rare disease and will qualify as orphan indication
following full-IND submission.
Based on the progress of the clinical programs the Company is also actively in
discussions with a number of potential commercial partners for programmes
across the Company's development portfolio.
In September 2023, ImmuPharma also completed a successful fundraising
comprising gross proceeds of £130,683 via the Winterflood Retail Access
Platform ("WRAP"), in addition to £1.35 million being raised in a
Subscription and Direct Subscription in August 2023.
SLE/P140 New dose strategy, study design and MOA clarity
There are an estimated 1.5 million people suffering from SLE in the US
(Source: SLE Foundation of America), 5 million in the US/Europe but 16 million
globally. The prevalence in China may be 3-4 times that seen in the US.
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 P140 has the potential to be a novel specific drug therapy
for the treatment of SLE by specifically restoring an imbalanced immune system
and halting disease progression in many autoimmune diseases, of which SLE is a
well-known example.
To this end, the whole P140 program was re-examined in 2021/22, and the Board
decided that it required a completely different approach, not only to commence
a new Phase 3 study in SLE, but also to be clear on the product offering and
target product profile. The three pillars of strength and confidence in our
new program are dose, design and MOA.
After three FDA guidance meetings, further human and animal pharmacokinetics
studies and reconciliation with efficacy demonstrated in the animal models, it
was concluded that the previous dose used in clinical studies was
significantly too low. The new Phase 3 study will include a dose-range over 20
times higher than the previous Phases 3 which used 200 micrograms.
The design of the pivotal Phase 3 study includes a dose-range. This design is
faster to complete than a Phase 2/3 adaptive study, while at the same time
incorporating all the key objectives. We confidently expect the efficacious
dose to be within this dose-range and we expect no adverse events that could
lead to product label warnings seen with all other approved drugs and standard
of care, which are all immunosuppressants. The study design allows two interim
analyses, so there will be short term updates on clinical activity of the
drug. P140 is not an immunosuppressant, so a key objective will be to taper
the use of steroids which are currently the standard of care. The study will
also include analysis of certain biomarkers in relation to efficacy.
The lack of immunosuppression is explained by our refined MOA. All other
molecules currently in development possess varying degrees of
immunosuppression, which give rise to side effects and limit the dose that can
be used to achieve efficacy.
New MOA evidence shows that P140 restores the tolerance systems by enabling
tolerogenic antigen presenting cells (like dendritic cells) to function
properly. As malfunction of the tolerance systems seems to be the root cause
of most if not all autoimmune diseases, it explains why P140 is so broadly
efficient across most autoimmune indications in animal models. P140 is the
only non-immunosuppressive molecule in the industry in clinical development
for the treatment of SLE. These insights and new internal data will provide
the potential to significantly fortify the intellectual property position of
P140.
This target product profile of P140 is a new gold standard therapy,
conveniently self-administered by the patient with the autoinjector, once a
month, which is safe and well tolerated unlike standard of care or any other
molecule in development which are all immunosuppressants with significant
safety warnings and quality of life impacts. The new Phase 3 design will aim
to study the ability to significantly reduce or remove the need or harmful
standard of care therapy i.e. oral steroids or other immunosuppressants.
Simbec-Orion
Simbec-Orion is an experienced, full-service Contract Research Organisation,
with offices across the UK, Europe, and the United States, specialising in
Rare & Orphan conditions. Simbec-Orion has previous direct experience in
SLE trials including conducting ImmuPharma's last Phase 3 study completed in
2018 and more recently conducted ImmuPharma's Pharmacokinetics ("PK") study
completed in 2022.
P140 and Avion Pharmaceuticals | Background
On 28 November 2019, ImmuPharma and Avion signed an exclusive Trademark,
License and Development Agreement for P140 (P140/Lupuzor™), with Avion
agreeing to fund a new international Phase 3 trial and commercialising in the
US. The agreement also provides Avion an option on any other P140 indications.
Since then, there have been three guidance meetings with the FDA on the SLE
program. At the first meeting the FDA requested ImmuPharma complete a clinical
PK study of P140.
The study was a Phase 1, open-label, single dose pharmacokinetic study of P140
after subcutaneous and intravenous administration in healthy male volunteers.
Patients received a single subcutaneous injection of 200μg or 800μg P140 or
a single intravenous injection of 800μg P140. There was a clear time and
dose-related PK profile, which is detectable in the blood of human volunteers
and applicable for all potential clinical dosing regimens of P140. In-line
with all human dosing to date, P140 was safe and well tolerated across all
doses and in all subjects.
Following successful completion of the clinical PK study in 2022 the FDA
guided on a new dosing regimen and following the receipt of comprehensive
guidance from the FDA in June 2023, in conjunction with our US partner Avion,
a Phase 2/3 adaptive clinical trial of P140 (Lupuzor™) in patients with SLE
was agreed.
Importantly however, after further deliberation between our clinical team,
Avion and our CRO, Simbec-Orion, taking into account the further positive
findings within the MOA of P140 (Lupuzor™), a Phase 3 study is the optimum
route forward.
The new design of the international Phase 3 study includes a dose-range. We
confidently expect the efficacious dose to be within this dose-range and we
expect no adverse events that could lead to product label warnings seen with
all other approved drugs and standard of care, which are all
immunosuppressants. The study design allows two interim analyses, so there
will be short term updates on clinical activity of the drug. P140 is not an
immunosuppressant, so a key objective will be to taper the use of steroids
which are currently standard of care. The study will also include analysis of
certain biomarkers in relation to efficacy.
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) / P140
A new major opportunity for P140 is for the treatment of CIDP, a rare acquired
autoimmune disorder of peripheral nerves with high medical need. It is a
neurological disorder characterised by progressive weakness and impaired
sensory function in the legs and arms. CIDP is a potential orphan drug
indication which would provide patent life extension of 7 years
post-approval.
For P140 in CIDP, we announced in April 2023 that we had received confirmation
from the FDA for a pre-Investigational New Drug ("PIND") meeting date of 16
May 2023, to consider a Phase 2/3 adaptive trial study protocol.
In May 2023, ImmuPharma received positive guidance from FDA following the PIND
meeting that confirms the route for a Phase 2/3 adaptive clinical study of
P140 in CIDP.
The FDA feedback recognises that P140 is suitable to be studied in another
disease indication in addition to SLE and this strongly supports the
underlying science and mechanism of action of P140 across several
auto-immune/inflammatory diseases and is a significant breakthrough for the
P140 platform.
The Phase 2/3 adaptive clinical trial will be the first pivotal stage study of
P140 in patients with CIDP: a rare neurological disease with high medical
need.
An IND application is now being prepared for submission to the FDA,
incorporating all guidance points. An application for Orphan Drug status for
CIDP will be also submitted in parallel to the full IND application.
Simbec-Orion has been appointed as the CRO for this program.
The CIDP market is expected to reach global sales of US$2.7bn by 2029.
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™ /P140 platform was invented by Prof. Sylviane
Muller, Emeritus 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 and through further commercialisation deals for
territories outside of the US.
Pipeline Overview
ImmuPharma is a biopharmaceutical company that specialises in the usage and
development of biopolymers, specifically peptides.
Our research strategy is based on two strategic axes: research based on
external collaboration aimed at discovering new active ingredients, which has
led to the development of our most advanced project in terms of clinical
development: P140, an active peptide against the auto-immune disease, SLE and
internal research based on the use of molecular programming technologies,
which has notably led to the development of the BioAMB (antifungal) and BioCIN
(antibacterial) projects.
Pipeline Overview (continued)
This research, for original biopolymer-based active compounds, has led us to
collaborate with the world-renowned Centre National de la Recherche
Scientifique, (CNRS) in France and Imperial College London. These
collaborations enable us to access innovative research with substantial
embedded value and to work with many leading scientists and clinicians.
ImmuPharma has exclusive rights to all of its intellectual property assets.
Since a major Board and management restructuring, the team has refocused its
key pipeline portfolio to maximise long-term shareholder value.
Our late-stage to preclinical pipeline is focused on two core therapeutic
areas; autoimmunity & inflammation and anti-infectives.
We also look for valuable deals for non-core assets as evidenced by a
collaborative deal, signed in March 2023, with Orano on ImmuPharma's peptide
technology as a vector for cancer radiotherapy. The initial collaboration is
for 12 months and a small undisclosed upfront payment was paid to ImmuPharma.
Autoimmunity & Inflammation
P140 is a peptide discovered by Professor Sylviane Muller and licensed to the
Company by our long standing collaboration partner, the CNRS.
Due to its "restorative" action on the immune system, P140 is a technology
platform that can be applied across many autoimmune and inflammatory
conditions. The Company is currently in clinical development of P140 for
the treatment of SLE and CIDP.
P140 (Lupuzor™) for SLE
Lupuzor™, (forigerimod or P140) has commenced an international, Phase 3,
dose-range pivotal study for systemic lupus erythematosus (SLE).
P140 is a peptide technology platform that targets autoimmune diseases such as
SLE. Like all autoimmune diseases there is currently no cure against SLE.
There are 2 approved monoclonal antibody treatments that are prescribed, but
in only 3% of SLE patients, otherwise, treatments are mostly steroids.
Overall, the treatments are mainly immunosuppressants which can have
significant side effects.
· P140 has the potential to be a new standard of care therapy for
the treatment of SLE.
· P140 binds to heat shock protein 8 (HSPA8), which is
over-expressed in abnormal antigen presenting cells.
· P140 "restores" the immune system back to normal, by enabling
tolerogenic antigen presenting cells to function properly. P140 is not an
immunosuppressant unlike other molecules in development.
· P140 is extremely safe, well-tolerated and patient friendly, and
potentially can be self-administered through a subcutaneous injection, once a
month for SLE.
P140 for CIDP
P140 (forigerimod) shows compelling pre-clinical data in Chronic Inflammatory
Demyelinating Polyneuropathy ("CIDP"), a progressive inflammatory condition of
the nerves.
P140's efficacy has been proven in early pre-clinical models of CIDP.
A phase 2/3 adaptive trial is planned in 2024. Applications for full FDA IND
and orphan drug designation are being prepared for submission. Full FDA IND
approval and orphan drug designation is expected following the result of the
Pre IND meeting.
P140 offers the potential to:
· reduce the frequency of CIDP disease flares
· reduce the need for hospital Intravenous Immunoglobulin Therapy
(IVIg) therapy
· simple auto-injection 1/month by patient at home
· reduce costs for patient and healthcare system
P140 - Other indications
A number of additional autoimmune-related indications have been identified
within the P140 platform. They all share the same common cause at the
mechanistic level of the cell. Pre-clinical studies have now confirmed P140
activity in asthma (acute and chronic), gout, periodontitis and IBD. There
have been no new significant drug classes addressing these indications for
many years.
What next?...
ImmuPharma has built up invaluable scientific knowledge by developing a
peptide compound which can potentially treat a range of auto-immune diseases.
Building on this experience, we are developing a new active peptide, targeting
specific autoimmune pathologies. This new research programme is perfectly
aligned with our strategic priorities. It's a very exciting project that
should create further opportunities for the Company.
Anti-Infection
Anti-infectives were chosen as a core therapy focus because of the
ever-looming threat of new and resistant organisms, with few significant new
products or even classes having been discovered or developed now for many
years.
The innovative peptide technology at ImmuPharma Biotech has been a huge
success and very recently has given rise to a number of novel development
programs, out of which we have identified two core programs, in pre-clinical
development: BioAMB and BioCin, which we believe have the best commercial
opportunity and speed to market. Despite the preclinical stage, these programs
are based on existing drugs that have been used for decades so the PK,
efficacy and safety of those drugs is well understood. They will also be
patent protected.
BioAMB | for systemic fungal infections
BioAMB is a groundbreaking amphotericin-B variant that promises both
efficiency and safety.
Although AMB is highly effective, currently marketed AMB formulations may
cause serious kidney toxicity and other severe reactions. BioAMB is not a
typical reformulation but a Bio-drug entity which releases AMB as the active
agent.
BioAMB aims to:
· Significantly reduce toxicity and improve tolerance to
amphotericin-B therapy
· Use a simple injection vs IV infusion
· Improve the frequency & duration of therapy
· Provide a more powerful alternative to existing 1st line azole
antifungal therapy where there is increasing resistance.
BioCIN | for severe bacterial infections
BioCIN is an innovative vancomycin-based treatment for efficient, safe,
anti-infection treatment.
Vancomycin, a generic drug, is a last resort therapy for the treatment of
sepsis and lower respiratory tract, skin, and bone infections caused by
Gram-positive bacteria and the killer bug methicillin-resistant Staphylococcus
aureus (MRSA).
Marketed since 1954, it is poorly absorbed from the gut and currently requires
carefully controlled IV therapy over many hours.
BioCIN aims to:
· Significantly reduce toxicity and improve tolerance to vancomycin
therapy
· Use a simple injection &/or oral admin vs IV infusion
· Improve the frequency & duration of therapy
· Improve efficacy through improved tolerance
Interest in Incanthera Plc
As at 31 December 2023, ImmuPharma had a 12.73% interest in Oncology
specialist, Incanthera plc, which trades on Aquis Stock Exchange ("AQSE")
under the ticker (TIDM:INC).
ImmuPharma also has 7,272,740 warrants options in Incanthera at an exercise
price of 9.5p pence. As announced in August 2023, the term of these Warrants
has been extended by 12 months to 6 September 2024, being the same price at
which new shares were issued in the Placing accompanying Incanthera's listing
in 2020.
On 18 December 2023, Incanthera announced a significant commercial skincare
deal with Marionnaud (part of the A.S. Watson Group) initially across Europe
and further roll outs in Asia. It confirmed that this deal is expected to
generate significant revenues and profitability for Incanthera, in 2024 and
beyond.
In conjunction, Incanthera announced that it had concluded a successful
fundraise of £1,000,000, with new and existing institutional investors, which
was oversubscribed, and was priced at £0.07, a premium of 11.1% to the
mid-market price at the close of trading on Friday 15 December 2023.
As a major shareholder in Incanthera during the year, we believe this is a
significant milestone, which highlights the enormous opportunities within
Incanthera's revolutionary skincare range and as such ImmuPharma remains
supportive of Incanthera.
More recently in April 2024, Incanthera provided an update to the agreement
with Marionnaud.
Under the terms of the deal, Skin + CELL, the brand name of Incanthera's
luxury skin care range, will be initially launched in c. 100 of Marionnaud's
stores in Switzerland and Austria, followed by a planned roll out into the
remaining 1,100 European stores, with subsequent anticipated roll outs into
major Asian markets.
Incanthera has announced that the first order from Marionnaud has now doubled
from 25,000 units to 50,000 units due to the strong demand anticipated by
Marionnaud's management and that this first order, on track to be delivered
during Q2 2024, will generate c. £2m revenue for Incanthera.
Incanthera also confirms that it projects revenues of £10m and profitability,
for the financial year ("FY") to 31 March 2025, growing to revenues of £33m
and increased profitability, in the following FY to 31 March 2026.
More insight into Incanthera's technology and deal with Marionnaud is
illustrated through the initiation of a Research Note by Stanford Capital
Partners, which will shortly be available on the Incanthera plc website
www.incanthera.com (http://www.incanthera.com) .
On 3rd June 2024 the Company sold its investment in shares in Incanthera plc.
All of the 9,904,319 shares held at the year end were sold at 15p per share
realising gross proceeds of £1.5 million. ImmuPharma continues to hold
7,272,740 warrants in Incanthera plc.
Capital subscription
On 31 August 2023, ImmuPharma announced subscriptions to raise £1.44 million
through the issue of 76,500,000 new ordinary shares of 1 pence each in the
Company ("Ordinary Shares") at a price of 2 pence per Ordinary Share ("Issue
Price") utilising existing authorities to allot shares. This comprised a
subscription subject to a Sharing Agreement of £1.0 million ("Subscription")
and Direct Subscriptions of £0.44 million. The Company also entered into a
sharing agreement ("Sharing Agreement") with finance provider and existing
shareholder, Lanstead Capital Investors L.P. ("Lanstead") in relation to £1.0
million of the amount subscribed by them under the Subscription.
Further on 7 September 2023, the Company confirmed that it had conditionally
raised gross proceeds of £130,683 through the issue of 6,534,150 New Ordinary
Shares at a price of 2 pence to existing retail investors of the Company, via
the Winterflood Retail Access Platform ("WRAP"), in addition to the £1.44
million raised in the Subscription and Direct Subscription.
Following admission of shares on 12 September 2023, the Company currently has
416,437,265 Ordinary Shares in issue. Since the Company currently holds no
shares in treasury, the total number of voting rights in the Company will
therefore be 416,437,265.
Variation of terms of the 2021 Warrants and the 2022 Warrants
In August 2023, there were a total of 101,042,350 warrants in issue. Of these,
64,545,455 warrants, with an exercise price of 11p and an exercise period
ending 23 December 2031 ("2021 Warrants"), were issued under a warrant deed in
December 2021 (see RNS notification headed "Subscription and Placing to raise
£3.55million" dated 20 December 2021). The holders of these 2021 Warrants are
Lanstead (40,000,000), Alora Pharmaceuticals, LLC (21,818,182) and an
Institutional shareholder (2,727,273).
A further 30,000,000 warrants, with an exercise price of 5.5p and an exercise
period ending 15 August 2032 ("2022 Warrants") were issued under a warrant
deed in August 2022 (see RNS notification headed "Subscription/Placing to
raise £1.1m; Broker Option" dated 3 August 2022). The holder of these 2022
Warrants is Lanstead (30,000,000).
These warrants are currently significantly "out of the money".
The warrant deeds (between the Company and the respective counter-parties -
the holders of warrants) have been varied, such that the exercise price of the
2021 Warrants and 2022 Warrants is reduced from 11 pence and 5.5 pence
respectively to 2 pence.
The 2021 Warrants and 2022 Warrants will then be exercisable at the earlier of
(i) the five day volume weighted average price of Ordinary Shares attaining 4
pence or (ii) 12 months following First Admission or (iii) a takeover offer is
announced for the Company. The reduction in the warrant exercise prices was
agreed with all the warrant holders and from the Company's perspective, there
will be a higher probability of receiving additional funding from the exercise
of these warrants as the share price appreciates and the warrants are 'in the
money'.
Following Second Admission the 101,042,350 warrants in issue represent 18.29
per cent of the fully diluted share capital (as enlarged following full
exercise of these warrants and outstanding options and assuming full take up
of the Retail Offer).
The Company issued 500,000 new Ordinary Shares to SPARK, and 3,750,000 new
Ordinary Shares to SCP at an issue price of 2 pence per share in lieu of
fees ("Fee Shares"). The Fee Shares were issued credited as fully paid and
will rank pari passu in all respects with the Company's existing issued
Ordinary Shares.
Current Activities and Outlook
As a Board, we remain focused on bringing our two key late stage clinical
assets, P140 (Lupuzor™) and CIDP, closer to the market, as well as securing
partnering deals for our earlier stage assets, specifically within our
anti-infectives program.
It has however taken longer than we anticipated to be at this crucial stage of
development as we are now, particularly within our late stage asset of P140
(Lupuzor™) for SLE.
We however have made significant scientific progress over the last year and
most importantly, following further detailed analysis of the protocol of the
P140 (Lupuzor™) study; new insights into the MOA of P140, combined with the
outstanding safety profile of the drug, we have compelling evidence that
moving directly into a pivotal Phase 3 study for P140 (Lupuzor™), is the
most appropriate route forward and as a result, we have a high level of
confidence of the success of this study.
The second half of 2023 was an extremely busy but focused period for the team
and I acknowledge the frustration of shareholders for the protracted period of
time to reach decisions, including the appointment of the CRO Simbec-Orion for
the P140 (Lupuzor™) Phase 3 study.
I thank everyone for their continued patience. We look forward to providing
further updates on the progress of this study, together with progress on CIDP
and our earlier stage programs throughout 2024.
We will also continue to concentrate on further commercial and partnering
opportunities. In conjunction with the above objectives, we continue to take
prudent measures on managing our cost base.
As a major shareholder in Incanthera, we are delighted with its progress over
the last year and in particular its deal with Marionnaud, for its innovative
luxury skincare product range.
In closing, we would like to thank our shareholders for their support as well
as our staff, corporate and scientific advisers and our partners including
CNRS and Avion.
Tim McCarthy
Chairman & CEO
Financial Review
The financial results of the ImmuPharma Group in this report cover the year
ended 31 December 2023. The Group's principal activity is that of research and
development of novel drugs to treat serious medical conditions.
Income Statement and Statement of Comprehensive Income
The operating loss for the year ended 31 December 2023 was £3.2 million, up
from £3.0 million for the year ended 31 December 2022. The research and
development expenditure was £2.0 million, in line with £2.0 million in 2022.
Administrative expenses were £1.0 million (2022: £0.8 million).
Finance income has increased from £28k in 2022 to £122k in 2023. Finance
costs amounted to £0.4 million, down from £1.5 million in 2022, caused
largely by the comparative fair value calculations on the Lanstead derivative
financial asset. The loss after tax for the year was £2.9 million, a decrease
from £3.8 million in 2022.
The amounts recognised directly in the Statement of Comprehensive Income
include the total fair value loss of £46k (2022: fair value loss of £726k)
which comprises the following components: fair value loss on shares held in
Incanthera plc of £45k (2022: fair value loss of £520k) and fair value loss
on Incanthera's warrants of £1k (2022: fair value loss of £206k). Total
comprehensive loss for the year was £3.0 million, a decrease from £4.5
million in 2022.
Statement of Financial Position
The Group cash and cash equivalents at 31 December 2023 amounted to £0.2
million (2022: £0.7 million) with the decrease caused by the cash used in
operating activities including research and development expenditure related to
PK study offset by cash inflows from financing and investing activities. Trade
and other payables increased to £1.7 million (2022: £1.5 million) and was
largely due to PK study related expenditure. The total value of the financial
asset equated to £0.6 million, comprising of shares in Incanthera of £0.6
million (2022: £0.7 million) and warrants in Incanthera of £1 (2022: £1k).
At 31 December 2023 the Lanstead derivative financial asset amounted to £0.6
million (2022: £0.3 million). The increase was a result of the fair value
calculation performed at year end, reflecting the new sharing agreement in the
period offset by amounts received and losses recognised.
Results
The Group recorded a loss for the year of £2.9 million (2022: £3.8 million).
Basic and diluted loss per share was 0.81p (2022: 1.26p). In accordance with
the Group's loss making position, no dividend is proposed.
Total Voting Rights & Warrants
The Company had a total of 701,422,198 ordinary shares in issue at 31 December
2023. The Company's issued share capital now comprises 416,437,265 Ordinary
Shares with one voting right each and 284,984,933 deferred shares with no
rights to vote. Total warrants outstanding equal: 101,042,908.
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
Tim McCarthy
Director
CONSOLIDATED INCOME STATEMENT
FOR THE YEAR ENDED 31 DECEMBER 2023
Year ended Year ended
31 December 2023 31 December 2022
£ £
Continuing operations
Revenue - -
Research and development expenses (2,022,305) (2,022,507)
Administrative expenses (1,020,345) (846,571)
Share based payment expense (140,238) (159,874)
Other operating income 119,881 -
Operating loss (3,063,007) (3,028,952)
Finance costs (358,915) (1,455,966)
Finance income 3,025 28,585
Loss before taxation (3,418,897) (4,456,333)
Tax 497,102 648,902
Loss for the year (2,921,795) (3,807,431)
Attributable to:
Equity holders of the parent company (2,921,795) (3,807,431)
Loss per ordinary share
Basic and diluted (0.81)p (1.26)p
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE YEAR ENDED 31 DECEMBER 2023
Year Year
ended 31 December ended 31 December
2023 2022
£ £
Loss for the financial period (2,921,795) (3,807,431)
Other comprehensive income
Items that will not be reclassified subsequently to profit or loss:
Fair value loss on investment (44,569) (519,977)
Fair value loss on warrants owned (1,228) (206,279)
Total items that will not be reclassified subsequently to profit or loss (45,797) (726,256)
Items that may be reclassified subsequently to profit or loss:
Exchange differences on translation of foreign operations 857 79,104
Total items that may be reclassified subsequently to profit or loss 857 79,104
Other comprehensive loss for the period (647,152)
(44,940)
Total comprehensive loss for the period (2,966,735) (4,454,583)
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 31 DECEMBER 2023
31 December 2023 31 December 2022
£ £
Non-current assets
Intangible assets 447,571 473,892
Property, plant and equipment 102,075 389,716
Derivative financial asset 184,784 82,563
Financial assets 643,782 689,579
Total non-current assets 1,378,212 1,635,750
Current assets
Trade and other receivables 467,780 723,583
Derivative financial asset 432,797 252,258
Cash and cash equivalents 208,481 667,813
Current tax asset 234,141 695,297
Total current assets 1,343,199 2,338,951
Current liabilities
Financial liabilities - borrowings - (111)
Trade and other payables (1,665,122) (1,451,213)
Total current liabilities (1,665,122) (1,451,324)
Net current (liabilities)/assets (321,923) 887,627
Net assets 1,056,289 2,523,377
EQUITY
Ordinary shares 29,813,018 28,982,676
Share premium 29,317,444 28,788,377
Merger reserve 106,148 106,148
Other reserves 5,902,591 5,761,496
Retained earnings (64,082,912) (61,115,320)
Total equity 1,056,289 2,523,377
The financial statements were approved by the Board of Directors and
authorised for issue on 4(th) June 2024
They were signed on its behalf by:
Tim
McCarthy
Tim Franklin
Director
Director
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE YEAR ENDED 31 DECEMBER 2023
Other reserves - Share based payment reserve
Other reserves - Acquisition reserve Other reserves - Translation reserve Other reserves - Warrant reserve
Share capital Share premium Merger reserve Retained earnings
Total equity
£ £ £ £ £ £ £ £ £
At 1 January 2022 28,498,494 27,237,329 106,148 (3,541,203) (1,344,657) 8,690,019 1,349,000 (56,581,633) 4,413,497
Loss for the financial year - - - - - - - (3,807,431) (3,807,431)
Exchange differences on translation
of foreign operations - - - - 79,104 - - - 79,104
Transactions with owners:
Share based payments - - - - - 159,874 - - 159,874
New issue of equity capital 484,182 1,866,727 - - - - - - 2,350,909
Costs of new issue of equity capital - (165,679) - - - - - - (165,679)
Fair value loss on investments - - - - - - - (519,977) (519,977)
Fair value loss on share warrants - - - - - - - (206,279) (206,279)
Issue of warrants - (150,000) - - - - 369,359 - 219,359
At 31 December 2022 28,982,676 28,788,377 106,148 (3,541,203) (1,265,553) 8,849,893 1,718,359 (61,115,320) 2,523,377
Loss for the financial year - - - - - - - (2,921,795) (2,921,795)
Exchange differences on translation
of foreign operations - - - - 857 - - - 857
Transactions with owners:
Share based payments - - - - - 140,238 - - 140,238
New issue of equity capital 830,342 782,842 - - - - - - 1,613,184
Costs of new issue of equity capital - (253,775) - - - - - - (253,775)
Fair value loss on investments - - - - - - - (44,569) (44,569)
Fair value loss on share warrants - - - - - - - (1,228) (1,228)
At 31 December 2023 29,813,018 29,317,444 106,148 (3,541,203) (1,264,696) 8,990,131 1,718,359 (64,082,912) 1,056,289
Equity holders of the parent company 29,813,018 29,317,444 106,148 (3,541,203) (1,264,696) 8,990,131 1,718,359 (64,082,912) 1,056,289
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE YEAR ENDED 31 DECEMBER 2023
Year ended Year ended
31 December 2023 31 December
2022
£ £
Cash flows from operating activities
Cash used in operations (note 3) (2,320,679) (3,224,906)
Tax received 958,258 879,877
Interest paid (1,986) (2,036)
Net cash used in operating activities (1,364,407) (2,347,065)
Investing activities
Purchase of property, plant and equipment - (106,009)
Proceeds from sale of property, plant and equipment
185,737 -
Interest received 3,025 28,585
Net cash generated from/(used in) investing activities 188,762 (77,424)
Financing activities
Settlements from Sharing Agreement 362,688 362,500
Gross proceeds from issue of new share capital 1,480,683 2,350,909
Share capital issue costs (121,275) (165,679)
Funds deferred per Sharing Agreement (1,000,000) (1,000,000)
Net cash generated from financing activities 722,096 1,547,730
Net decrease in cash and cash equivalents (453,549) (876,759)
Cash and cash equivalents at beginning of year 667,813 1,649,374
Effects of exchange rates on cash and cash equivalents (5,783) (104,802)
Cash and cash equivalents at end of year (excluding overdraft) 208,481 667,813
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 2023 or 31 December 2022.
The financial information has been extracted from the statutory accounts for
the years ended 31 December 2023 and 31 December 2022. 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 2023 and 31 December 2022. For
the year ended 31 December 2023 and 31 December 2022 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, and a reference to which the auditor drew attention by way of
emphasis without qualifying their report in respect of going concern.
The Group's statutory accounts for the year ended 31 December 2022 have been
delivered to the Registrar of Companies, whereas those for the year ended 31
December 2023 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 2022 and interim
results for the period ended 30 June 2023, which have been prepared in
accordance with International Financial Reporting Standards ('IFRS').
The financial information is for the year ended 31 December 2023 and the
comparatives are for the year ended 31 December 2022.
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.
2 LOSS PER SHARE
- Group Year ended 31 December 2023 Year ended
31 December 2022
£ £
Loss
Loss for the purposes of basic loss per share being net loss after tax (2,921,795)
attributable to equity shareholders
(3,807,431)
Number of shares
Weighted average number of ordinary shares for the purposes of basic earnings
per share
362,004,551 302,912,903
Basic loss per share (0.81)p (1.26)p
Diluted loss per share (0.81)p (1.26)p
The Group has granted share options in respect of equity shares to be issued,
the details of which are disclosed in note 20.
There is no difference between basic loss per share and diluted loss per share
as the share options and warrants are anti-dilutive.
3. CASH USED IN OPERATIONS
Group Group Company Company
31 December 2023 31 December 2022 31 December 2023 31 December 2022
£ £ £ £
Operating loss (3,063,007) (3,028,952) (1,763,564) (1,567,079)
Depreciation and amortisation 37,607 117,563 3,050 4,312
Loss on sale of fixed assets 94,882 939 - 939
Share-based payments 140,238 159,874 112,676 129,799
Decrease/(increase) in trade and other receivables 255,803 (296,384)
183,155 37,900
Increase/(decrease) in trade and other payables 213,798 (132,392)
775,093 (505,554)
Gain on foreign exchange - (45,554)
(318,015) -
Cash used in operations (2,320,679) (3,224,906) (1,007,605) (1,899,683)
4. POST BALANCE SHEET EVENTS
On 3rd June 2024 the company sold its investment in shares in Incanthera plc.
The 9,904,319 shares held at the year end were sold at 15p per share realising
gross proceeds of £1.5million.
5. ANNUAL REPORT
The annual report for the year ended 31 December 2023 will be posted to
shareholders shortly and will be made available on the Company's website
www.immupharma.co.uk (http://www.immupharma.co.uk/) .
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