REG - Immupharma PLC - Half-year Report
09/09/2024 07:00
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RNS Number : 3290D Immupharma PLC 09 September 2024
RNS: RELEASE | 9 September 2024
ImmuPharma PLC
("ImmuPharma" or the "Company")
INTERIM RESULTS
for the six months ended 30 June 2024
ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug
discovery and development company, is pleased to announce its interim results
for the six months ended 30 June 2024 (the "Period").
Key Highlights (including post Period review)
Financials
· Loss for the Period of £0.4m (30 June 2023: £0.8m)
· Research and development expenses of £0.5m (30 June 2023: £0.8m)
· Administrative expenses of £0.3m (30 June 2023: £0.4m)
· Share based expense of £0.03m (30 June 2023: £0.1m)
· Cash balance of £1.1m as at 30 June 2024 (30 June 2023: £0.2m)
· Derivative financial asset of £0.5m as at 30 June 2024 (30 June
2023: £0.3m)
· Basic and diluted loss per share of 0.09p (30 June 2023: 0.25p)
Portfolio
P140 technology platform
· New insights into P140's mechanism of action ("MOA") confirms its
position as the only non-immunosuppressing therapy in clinical development in
the industry for autoimmune diseases
· P140's MOA support its potential not only for SLE sufferers, but
for patients suffering from a multitude of autoimmune diseases that are caused
by the same underlying immune system 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
SLE (Lupus)
· A Phase 3 dose-range study of P140 continues preparation in
collaboration with Simbec-Orion, the designated Contract Research Organisation
("CRO")
· The new 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
· The monthly dose level administered by subcutaneous injection
will be significantly higher
CIDP
· A Phase 2/3 adaptive clinical study of P140 in CIDP is planned
following positive guidance from a Pre-Investigational New Drug (PIND) meeting
with the FDA last year
· An IND application is now close to submission to the FDA,
incorporating all guidance points
· Simbec-Orion, has been appointed as the CRO for this program
Preclinical Portfolio
· The core anti-infective program with antifungal (BioAMB) and
antibacterial (BioCIN) candidates are progressing through pre-clinical studies
· The non-core anticancer collaboration with Orano SA is ongoing
Incanthera
· On 3 June 2024 ImmuPharma divested its investment in shares in
Incanthera. 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.
· Announced today: As confirmed by a separate announcement issued
today, the warrants of 7,272,740 held in Incanthera have been extended to 31
March 2025. See separate announcement for full details of the transaction.
Commenting on the statement and outlook Tim McCarthy, CEO and Chairman, said:
"We remain committed as a Board, on the development of P140 in SLE and CIDP,
our two key late-stage clinical assets, together with securing additional
partnering for P140. We have made significant scientific progress over the
last period, including refinement of the protocols for the SLE and CIDP
studies and new insights into the MOA of P140, and as a result, we have a high
level of confidence of the success of these new studies.
We will also continue to concentrate on securing further commercial and
partnering deals, on which we have made significant progress over the last 6
months.
On an operational level, we have continued our focus on tight cost controls
and maximising the use of outsourcing to keep our committed overhead costs to
the minimum. This is illustrated very clearly in the reduction of our
operating loss for the period to £0.4m down from £0.8m for the same period
last year. We have also strengthened the balance sheet and extended our cash
runway by successfully selling our shareholding in Incanthera, whilst still
retaining a further 7.3 million warrants.
We look forward to providing further updates on the progress of our pipeline
and commercial deals throughout the remaining period of 2024 and moving into
2025.
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."
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 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) + 44 (0) 2072 062650
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) 203 815 8880
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
ImmuPharma plc
INTERIM RESULTS
FOR THE SIX MONTH PERIOD ENDED 30 JUNE 2024
ImmuPharma plc
Chairman's Statement
Chairman's Report
The first part of 2024 has been a period of progress for ImmuPharma, with our
late-stage pipeline assets, specifically within our P140 autoimmune technology
platform, where we have gained new insights into the MOA which is
strengthening our discussions with potential partners.
There has also been continuing significant attention to tight financial
management and stability over the period, which is highlighted in the key
financial highlights. But in summary, this is reflected in the operating
loss for the period reducing to £0.4m down from £0.8m for the previous
period.
P140 / SLE & CIDP
Preparation for a new international, dose-range, Phase 3 study in systemic
lupus erythematosus ("SLE") is underway with Simbec-Orion, our appointed
Contract Research Organisation ("CRO").
There are a number of significant improvements in the new Phase 3 study
design compared to the one completed by ImmuPharma in 2018. Of particular note
are dose levels of P140, administered through subcutaneous injection, which
will be significantly higher.
Our second major clinical study addresses chronic idiopathic demyelinating
polyneuropathy ("CIDP"), a high medical need autoimmune disease. 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 qualifies as
an orphan indication.
An IND application is now being prepared for submission to the FDA,
incorporating all guidance points and Simbec-Orion has been appointed as the
CRO for this program.
New insights into P140's mechanism of action ("MOA") explain why it is the
only non-immunosuppressing therapy in clinical development in the industry for
autoimmune diseases. P140's MOA supports its potential as a therapy for
patients suffering from a multitude of autoimmune diseases that are caused by
the same underlying malfunction. This agrees with preclinical animal models
where P140 has demonstrated efficacy in several autoimmune diseases, for
example, asthma (acute and chronic), gout, periodontitis, IBD and Sjogren's
disease.
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.
Anti-Infection
Anti-infection (antifungal and antibacterial) was chosen as a core therapy
focus because of the continual emergence and threat of new and drug-resistant
fungi and bacteria.
The innovative peptide technology at ImmuPharma Biotech has been a huge
success and very recently has given rise to two 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. The new entities include BioAMB (a new
antifungal based on amphotericin-B) and BioCIN (a new antibacterial based on
vancomycin) and will be fully patent protected.
Interest in Incanthera Plc
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. As of 6 September 2024, the warrants
have been extended to 31 March 2025. See announcement issued on 9 September
2024 for further information.
Current Activities and Outlook
We remain committed as a Board, on the development of P140 in SLE and CIDP,
our two key late-stage clinical assets, together with securing additional
partnering for P140. We have made significant scientific progress over the
last period, including refinement of the protocols for the SLE and CIDP
studies and new insights into the MOA of P140, and as a result, we have a high
level of confidence of the success of these new studies.
We will also continue to concentrate on securing further commercial and
partnering deals, on which we have made significant progress over the last 6
months.
On an operational level, we have continued our focus on tight cost controls
and maximising the use of outsourcing to keep our committed overhead costs to
the minimum. This is illustrated very clearly in the reduction of our
operating loss for the period to £0.4m down from £0.8m for the same period
last year. We have also strengthened the balance sheet and extended our cash
runway by successfully selling our shareholding in Incanthera, whilst still
retaining a further 7.3 million warrants.
We look forward to providing further updates on the progress of our pipeline
and commercial deals throughout the remaining period of 2024 and moving into
2025.
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
6(th) September 2024
ImmuPharma plc
CONSOLIDATED INCOME STATEMENT
FOR THE PERIOD ENDED 30 JUNE 2024
Unaudited Audited Year ended 31 December 2023 Unaudited 6 months ended
6 months ended 30 June 2023
30 June 2024
Note
£ £ £
Continuing operations
Revenue - - 69,959
Research and development expenses (473,521) (2,022,305) (828,767)
Administrative expenses (258,023) (1,020,345) (412,277)
Share based expense (32,683) (140,238) (127,327)
Other operating income - 119,881 -
(764,227) (3,063,007) (1,298,412)
Operating loss
Finance costs 6 (3,150) (358,915) (931)
Finance income 172,610 3,025 162,286
Loss before taxation (594,767) (3,418,897) (1,137,057)
Tax 206,915 497,102 289,691
Loss for the period (387,852) (2,921,795) (847,366)
Attributable to:
Equity holders of the parent company (387,852) (2,921,795) (847,366)
Loss per ordinary share
Basic and diluted 2 (0.09)p (0.81)p (0.25)p
ImmuPharma plc
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
FOR THE PERIOD ENDED 30 JUNE 2024
Unaudited Audited Year Unaudited 6 months ended
6 months ended ended 31 December 2023 30 June
30 June 2023
2024
£ £ £
Loss for the financial period (387,852) (2,921,795) (847,366)
Other comprehensive income
Items that will not be reclassified subsequently to profit or loss:
Fair value gain/(loss) on investment 730,266 (44,569) (54,474)
Fair value gain/(loss) on warrants 1,240,831 (1,228) 7,421
Total items that will not be reclassified subsequently to profit or loss 1,971,097 (45,797) (47,053)
Items that may be reclassified subsequently to profit or loss:
Exchange differences on translation of foreign operations 19,008 857 (18,897)
Total items that may be reclassified subsequently to profit or loss 19,008 857 (18,897)
Other comprehensive gain/(loss) for the period
1,990,105 (44,940) (65,950)
Total comprehensive gain/(loss) for the period 1,602,253 (2,966,735) (913,316)
ImmuPharma plc
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 30 JUNE 2024
Note Unaudited Audited Year Unaudited 6 months ended
6 months ended ended 31 December 2023 30 June
30 June 2023
2024
£ £ £
Non-current assets
Intangible assets 460,182 447,571 463,207
Property, plant and equipment 87,580 102,075 332,992
Financial 1,240,826 643,782 642,526
asset
Derivative financial asset 4 83,561 184,784 36,466
Total non-current assets 1,872,149 1,378,212 1,475,191
Current assets
Trade and other receivables 348,718 476,780 705,867
Cash and cash equivalents 1,084,440 432,797 210,584
Current tax asset 345,942 208,481 624,429
Derivative financial asset 4 411,414 234,141 272,388
Total current assets 2,190,514 1,343,199 1,813,268
Current liabilities
Trade and other payables (1,371,438) (1,665,122) (1,551,071)
Total current liabilities (1,371,438) (1,665,122) (1,551,071)
Net current assets 819,076 (321,923) 262,197
Net assets 2,691,225 1,056,289 1,737,388
EQUITY
Ordinary shares 5 29,813,018 29,813,018 28,982,676
Share premium 29,317,444 29,317,444 28,788,377
Merger reserve 106,148 106,148 106,148
Other reserves 5,954,282 5,902,591 5,869,926
Retained earnings (62,499,667) (64,082,912) (62,009,739)
Total equity 2,691,225 1,056,289 1,737,388
ImmuPharma plc
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE PERIOD ENDED 30 JUNE 2023
Ordinary shares Other reserves -Share based payment reserve Total
£ £ Equity
£
Other Other Other reserves - Warrant reserve
reserves - reserves - £
Share premium Merger Acquisition Translation Retained
£ Reserve Reserve Reserve Earning
£ £ £ £s
At 1 January 2023 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 period - - - - - - - (847,366) (1,663,788)
Exchange differences (18,897) - (18,897)
- - - - - - -
Share based payments - - - - - 127,327 - - 127,327
Fair value loss on investments - - - - - - - (54,475) (54,475)
Fair value gain on warrants - - - - - - - 7,421 7,421
At 30 June 2023 unaudited 28,982,676 28,788,377 106,148 (3,541,203) (1,284,450) 8,977,220 1,718,359 (62,009,739) 1,737,388
At 1 January 2023 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 - - - - - - (3,807,431) (2,921,795)
Exchange differences - - - 857 - - - 857
Share based payments - - - - - 140,238 - - 140,238
New issue of equity capital 830,342 782,842 - - - - - - 1,613,184
Cost of new issue of equity capital - (253,775)) - - - - - - (253,775)
Fair value loss on investments - - - - - - - (44,569) (44,569)
Fair value loss on warrants - - - - - - - (1,228) (1,228)
At 31 December 2023 & 1 January 2024 audited 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
Loss for the financial period - - - - - - - (387,852) (387,852)
Exchange differences
- - - - 19,008 - - 19,008
Share based payments - - - - - 32,683 - - 32,683
Fair value loss on investments - - - - - - - 730,266 730,266
Fair value gain on warrants - - - - - - - 1,240,831 1,240,831
At 30 June 2024 unaudited 29,813,018 29,317,444 106,148 (3,541,203) (1,245,688) 9,022,814 1,718,359 (62,499,667) 2,691,225
ImmuPharma plc
CONSOLIDATED STATEMENT OF CASHFLOWS
FOR THE PERIOD ENDED 30 JUNE 2024
Note Unaudited Audited Year Unaudited 6 months ended
6 months ended ended 31 December 2023 30 June
30 June 2023
2024
£ £ £
Cash flows from operating activities
Cash used in operations 3 (1,085,950) (2,320,679) (990,977)
210,000 958,258 338,992
Tax received
Interest paid (776) (1,986) (932)
(876,726) (1,364,407) (652,917)
Net cash used in operating activities
Investing activities
Proceeds from sale of property, plant and equipment - 185,737 -
Proceeds from sale of investment 1,477,698 - -
Interest received 1,844 3,025 1,464
Net cash (used in)/generated from investing activities 1,479,542 188,762 1,464
Financing activities
Decrease in bank overdraft - - (109)
New loans/(loan repayments) - - -
Settlements from Sharing Agreement 293,372 362,688 184,951
Gross proceeds from issue of new share capital - 1,480,683 -
Share capital issue costs - (121,275) -
Funds deferred per Sharing Agreement - (1,000,000) -
Net cash generated from financing activities 293,372 722,096 184,842
Net (decrease) in cash and cash equivalents 896,188 (453,549) (466,612)
Cash and cash equivalents at start of period 208,481 667,813 667,813
Effects of exchange rates on cash and (20,229) (5,783) 9,382
cash equivalents
Cash and cash equivalents at end of period 1,084,440 208,481 210,583
ImmuPharma plc
NOTES TO THE CONSOLIDATED INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2024
1 ACCOUNTING POLICIES
Basis of preparation
The interim financial information in this report has been prepared using
accounting policies consistent with IFRS as adopted by the United Kingdom.
IFRS is subject to amendment and interpretation by the International
Accounting Standards Board (IASB) and the IFRS Interpretations Committee and
there is an ongoing process of review and endorsement by the UK Endorsement
Board. The financial information has been prepared on the basis of IFRS
expected to be adopted by the United Kingdom and applicable as at 31 December
2023. The Group has chosen not to adopt IAS 34 "Interim Financial Statements"
in preparing the interim financial information.
The accounting policies applied are consistent with those that were applied to
the financial statements for the year ended 31 December 2023.
Non-Statutory accounts
The financial information set out in this interim report does not constitute
the Group's statutory accounts, within the meaning of Section 434 of the
Companies Act 2006. The statutory accounts for the year ended 31 December 2023
have been filed with Registrar of Companies. The auditors reported on those
accounts; their report was unqualified, did not contain a statement under
either Section 498 (2) or Section 498 (3) of the Companies Act 2006 but did
include 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.
ImmuPharma plc
NOTES TO THE CONSOLIDATED INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2024
(Continued)
2 LOSS PER SHARE
Unaudited Audited Year Unaudited 6 months ended
6 months ended ended 31 December 2023 30 June
30 June 2023
2024
£ £ £
Loss
Loss for the purposes of basic and diluted loss per share being net loss (387,852) (2,921,795) (847,366)
attributable to equity shareholders
Number of shares
Weighted average number of ordinary shares for the purposes of basic loss per 416,437,268 362,004,551 333,403,115
share
(0.09)p (0.81)p (0.25)p
Basic loss per share
Diluted loss per share (0.09)p (0.81)p (0.25)p
There is no difference between basic loss per share and diluted loss per share
as the share options and warrants are anti-dilutive. Deferred shares are
excluded from the loss per share calculation as they have no attributable
earnings.
ImmuPharma plc
NOTES TO THE CONSOLIDATED INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2024
(Continued)
3 CASH USED IN OPERATIONS
Unaudited Audited Year Unaudited 6 months ended
6 months ended ended 31 December 2023 30 June
30 June 2023
2024
£ £ £
Operating loss (764,227) (3,028,952) (1,298,417)
Depreciation & amortisation 18,842 117,563 86,639
Share based payments 32,683 159,874 288,826
(Increase)/decrease in trade & other receivables (81,938) (132,392) 17,716
(Decrease)/increase in trade & other payables (293,684) (296,384) 99,858
Gain / (loss) on foreign exchange 2,374 (45,554) 3,752
Cash used in operations (1,085,950) (3,224,906) (990,977)
4 Derivative Financial Asset
As part of the placement completed in March 2020, the Company issued
13,000,000 new ordinary shares to Lanstead Capital Investors L.P. ("Lanstead")
at a price of 10p per share for an aggregate subscription price of £1.3m
before expenses. In December 2021, the Company issued 20,000,000 new ordinary
shares to Lanstead at a price of 11p per share to raise £2.2m before
expenses. In the placement completed in August 2022, the Company issued
20,000,000 new ordinary shares to Lanstead at a price of 5p per share to raise
£1m gross. In the placement completed in August 2023, the Company issued
50,000,000 new ordinary shares to Lanstead at a price of 2p per share to raise
£1m gross. All Subscriptions proceeds were pledged under the Sharing
Agreement, under which Lanstead made and will continue to make, subject to the
terms and conditions of that Sharing Agreement, monthly settlements to the
Company that are subject to adjustment upwards or downwards depending on the
Company's share price performance.
In December 2021 and August 2022, the Company also issued 1,400,000 new
ordinary shares consecutively and 4,750,000 in August 2023 to Lanstead as
value payments in connection with the Share Subscriptions and the Sharing
Agreements. The settlements from remaining agreements (December 2021, August
2022 and August 2023) will continue until 2025, completing in June 2024,
October 2024 and October 2025 respectively.
At the end of the accounting period the amount receivable has been adjusted to
fair value based upon the share price of the Company at that date. Any change
in the fair value of the derivative financial asset is reflected in the income
statement. As at 30 June 2024, the Company completed a calculation of fair
value of the derivative financial asset that resulted in a finance gain of
£170,766 (£142,439 loss at 30 June 2023), which was recorded in the income
statement. The restatement to fair value will be calculated at the end of each
accounting period during the course of each Sharing Agreement and will vary
according to the Company's share price performance.
ImmuPharma plc
NOTES TO THE CONSOLIDATED INTERIM ACCOUNTS FOR THE PERIOD ENDED 30 JUNE 2024
(Continued)
5 Issued share capital
At 30 June 2024, the Company had no limit on its authorised share capital.
Allotted, called up and fully paid 30 June 2024 No. 31 December 2023 No. 30 June 2024 £ 31 December
2023 £
At start of year:
Ordinary shares of £0.01 each 416,437,265 333,403,115 4,164,374 3,334,031
Deferred shares of £0.09 each 284,984,933 284,984,933 25,648,644 25,648,644
Movements during period:
Ordinary shares issued on 22 August - 76,500,000 - 765,000
2023
Ordinary shares issued on 7 September - 6,534,150 - 65,343
2023
At end of the period
Ordinary shares of £0.01 each 416,437,265 416,437,265 4,164,374 4,164,374
Deferred shares of £0.09 each 284,984,933 284,984,933 25,648,644 25,648,644
6. Subsequent events
On 6 September 2024, the 7,272,740 warrants held in Incanthera Plc were
extended from 6 September 2024 to 31 March 2025 for a consideration of
£75,000.
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