REG - Nuformix PLC - Half-year Report
13/12/2022 07:00
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RNS Number : 4440J Nuformix PLC 13 December 2022
Nuformix plc
("Nuformix", the "Company" or the "Group")
Half Year Report
13 December 2022: Nuformix plc (LSE: NFX), a pharmaceutical development
company targeting unmet medical needs in fibrosis and oncology via drug
repurposing, announces its unaudited results for the six months ended 30
September 2022.
Operational highlights (including post-period end)
· Initial pre-clinical inhalation studies undertaken with NXP002
demonstrated:
o the proprietary novel form can be delivered in-vivo by a range of
nebulisers at the optimum particle size for delivery to the deep lung;
o very high doses appear to be well-tolerated in the lung; and
o an in-vivo inhalation dose response was observed for both inflammatory and
fibrotic biomarkers associated with disease progression.
· Subsequently, the Company initiated studies in a state-of-the-art 3D
human Idiopathic Pulmonary Fibrosis ("IPF") lung tissue, using a disease and
species relevant model, which will focus firstly on the anti-inflammatory and
anti-fibrotic action of NXP002 in combination with current standards-of-care
and secondly investigate duration of action.
· The Company presented NXP002 for the first time to the global IPF
medical and pharmaceutical specialist community at the ERS Congress in
Barcelona.
· A programme of work to progress NXP004 was initiated:
o scale-up of lead cocrystal production processes; and
o in-vitro dissolution comparison of lead co-crystals to Lynparza®
(commercially available olaparib).
· Oxilio, the licensee of NXP001, is investigating aprepitant for the
potential new treatment of cancer indications. Continuing efforts are being
made with Quotient Sciences to explore the formulation development options of
NXP001 to understand the feasibility of achieving bioavailability and a dosing
regime adequate for treatment of this indication. This work, which is
contingent on the manufacturing and supply of additional cocrystal material
for testing and evaluation, is underway.
· Leadership team enhanced with the appointments of:
o Dr Julian Gilbert as Non-Executive Chairman, who brings significant pharma
and biotech business development, corporate development and general leadership
experience; and
o Dr Dan Gooding as Executive Director, who is a co-founder of Nuformix and
was the Company's CEO until June 2020. He instigated the Company's NXP002
programme as an inhaled therapy for the treatment of IPF and has been acting
as a consultant to the Company since March 2022.
Financial Highlights
· Loss before tax £423,677 (30 September 2021: loss of £449,023)
· Loss on ordinary activities (after tax credit) of £422,514 (30
September 2021: loss of £449,023)
· Loss per share 0.06p (30 September 2021: 0.08p)
· Net assets of £4,591,964 (30 September 2021: £5,250,968) including
£389,840 of cash and cash equivalents at 30 September 2022 (30 September
2021: £1,071,831)
Dr Dan Gooding, Executive Director of Nuformix, said: "Our pre-clinical
efforts to date demonstrate that inhaled treatment of IPF and related fibrotic
lung diseases via NXP002 is a viable concept, a concept that it is becoming
increasingly validated by clinical data emerging from the public domain. I
expect our on-going penultimate pre-clinical studies to conclude that our data
and IP support the progression of the programme towards patients for whom I
believe NXP002 can address both the side effect and efficacy limitations of
existing IPF treatment options. We hope to announce results for both NXP002
and NX004 in the near-term, with work on both programmes underway. Programme
progression is being achieved using existing funds thanks to a lean
operational model, which will continue to operate until our R&D and
targeted partnering activities require further resource. I am excited by our
prospects for the remainder of the year and look forward to sharing results as
they emerge."
Enquiries:
Nuformix plc
Dr Dan Gooding, Executive Director Via IFC Advisory
Stanford Capital Partners Limited
Tom Price / Patrick Claridge (Corporate Finance) +44 (0) 20 3650 3650
John Howes (Corporate Broking) +44 (0) 20 3650 3652
IFC Advisory Limited
Tim Metcalfe +44 (0) 20 3934 6630
Zach Cohen nuformix@investor-focus.co.uk
About Nuformix
Nuformix is a pharmaceutical development company targeting unmet medical needs
in fibrosis and oncology via drug repurposing. The Company aims to use its
expertise in discovering, developing and patenting novel drug forms, with
improved physical properties, to develop new products in new indications that
are, importantly, differentiated from the original (by way of dosage, delivery
route or presentation), thus creating new and attractive commercial
opportunities. Nuformix has a pipeline of pre-clinical assets with potential
for significant value and early licensing opportunities.
Nuformix plc shares are traded on the London Stock Exchange's Official List
under the ticker: NFX. For more information, please visit www.nuformix.com
(http://www.nuformix.com/) .
Chairman's statement
Operational review
NXP002 (new form of tranilast) - Idiopathic Pulmonary Fibrosis (IPF)
NXP002 is the Group's pre-clinical lead asset and a potential novel inhaled
treatment for IPF and possibly other fibrosing interstitial lung diseases
("ILDs"). It is a proprietary, new form of the drug tranilast, to be delivered
in an inhaled formulation.
IPF is a devastating lung disease associated with a higher mortality rate than
many cancers and where there is a need for additional treatment options. Thus,
IPF represents a high unmet medical need and a significant commercial
opportunity. IPF is classified as a rare disease and presents a global
commercial market that is forecast to grow to US$8.8bn by 2027. Sales of
standard-of-care therapies OFEV and Esbriet achieved US$2.5bn and US$1bn
respectively in 2021.
Tranilast has a long history of safe use as an oral drug for allergies, but
there is evidence that supports its potential in fibrosis, including IPF.
NXP002 is differentiated as it is a new form of tranilast that is being
formulated for delivery direct to the lungs by inhalation, a new route of
administration for this drug. The inhalation route is a well-known strategy
for treatment of lung diseases to yield greater efficacy and reduce systemic
side-effects compared to oral treatment. Nuformix has two patent families
protecting new forms of tranilast, some members of which have been granted in
major pharmaceutical territories, while others are still in prosecution. In
addition, in March 2022 a method of use patent application was filed.
NXP002, as a potential treatment for IPF, is a likely candidate for Orphan
Drug Designation which could provide additional product protection against
potential competitors. The positioning of such an inhaled treatment for IPF
could be either added to standard of care or administered as a monotherapy.
The pre-clinical inhalation strategy, initiated by the Company has
significantly progressed NXP002 demonstrating:
· it can be delivered in-vivo by a range of nebulisers at the
optimum particle size;
· very high doses appear to be well-tolerated; and
· an in-vivo inhalation dose response was observed for inflammatory
and fibrotic biomarkers that is consistent with previous ex-vivo human IPF
tissue studies.
However, the pre-clinical inhalation disease model chosen proved to be
complex, and unlike previous studies in human IPF tissue, it continues to be
challenging to achieve consistent and reproducible results, which will likely
increase in the study of combination therapies, which are now clearly required
given the clinical trends intelligence gathered at the ERS. As a consequence,
the Company initiated studies in 3D human IPF lung tissue using a disease and
species relevant model that is now available commercially via a CRO. Work will
focus on NXP002 in combination with current standards-of-care, with the
ultimate aim of reducing their negative side effects whilst enhancing their
efficacy.
NXP002 combinations have already shown great promise in human diseased IPF
tissue, showing a pleasing synergistic efficacy effect with low doses of
standards-of-care, resulting in the Group filing a new combination patent
application earlier in 2022. The change in pre-clinical strategy, supported by
intelligence gathered at ERS, is therefore aligned with and further enhances
the Company's overall patent position as it continues to build assets for
eventual out-licensing.
The Company presented NXP002 for the first time to the global IPF medical and
pharmaceutical specialist community at the ERS Congress in Barcelona. The
Company's NXP002 poster sessions were well-attended by, amongst others,
potential licensing partners, while the conference confirmed that inhalation
is now widely accepted as a future IPF treatment modality.
Overall, the Board is encouraged by the progress of the studies and the
positive data generated to date and is considering next steps, including
potential further R&D studies to add further value and licensing
activities.
NXP004 (novel forms of olaparib) - Oncology
The Group discovered novel forms of olaparib, a drug currently marketed by
AstraZeneca, a Lynparza®. Lynparza® was first approved in December 2014 for
the treatment of adults with advanced ovarian cancer and deleterious or
suspected deleterious germline BRCA mutation. Since then, it has secured
similar approvals in breast, pancreatic and prostate cancers with further
trials on-going. These approvals have propelled Lynparza® sales to US$2.7bn
in 2021 with industry analysts forecasting annual sales of US$9.7bn by 2028.
The Group has filed two patent applications on its novel forms of olaparib
with the potential for patent life to 2040/2041.
The Company demonstrated enhanced performance of NXP004 cocrystals compared to
olaparib. Subsequently, further preformulation studies allowed the Company to
identify lead cocrystals to be progressed for further development.
The Company initiated work to progress the NXP004 programme in three key
areas:
· commence scale-up of lead cocrystal production processes;
· compare in-vitro dissolution performance of lead co-crystals to
the marketed Lynparza product; and
· based on the results from these studies a formulation development
programme may be initiated. The aims of this work will be to develop prototype
formulations that offer the potential to be both bioequivalent and
'bio-better' versus the Lynparza product.
This work will direct and support future out-licensing discussions for NXP004.
NXP001 (new form of aprepitant) - Oncology
NXP001 is a proprietary new form of the drug aprepitant that is currently
marketed as a product in the oncology supportive care setting (chemotherapy
induced nausea and vomiting). Nuformix granted an exclusive licence to Oxilio
Ltd ("Oxilio"), a privately held pharmaceutical development company, to
license NXP001 globally for oncology indications on terms previously
disclosed. Continuing efforts are being made with Quotient Sciences to explore
the formulation development options of NXP001 to understand the feasibility of
achieving bioavailability and a dosing regime adequate for treatment of this
indication. This work which is contingent on the manufacturing and supply of
additional cocrystal material for testing and evaluation is underway.
Board changes
In the period from April 2022 to September 2022 a number of Board changes have
occurred:
· appointment of Dr Julian Gilbert as Non-Executive Chairman,
previously a Non-executive Director, replacing Dr Alastair Riddell who
resigned in May 2022
· appointment of Dr Dan Gooding as an Executive Director who is a was a
co-founder of Nuformix and the Company's CEO until June 2020
Outlook
The Company to continues to advance and exploit the current assets within the
portfolio through the R&D and business development activities as set out
above. The sharing agreement with Lanstead provides cash on a monthly basis to
the Company to fund its lean operations until the Group's R&D and targeted
partnering activities require further resource.
The strategy of the Group is to continue to increase the value of its existing
assets while maintaining tight control of costs, including conducting business
development/licensing activities using a structured and data-driven approach,
with the goal of seeking global licensing deals.
Financial Review
In the first half of the financial year, the Board has continued to focus
expenditure on R&D activities that add value to the current assets while
optimising the operation to minimise administrative expenditure and the
operational cost-base.
Dr Julian Gilbert
Non-Executive Chairman
12 December 2022
Statement of Directors' Responsibilities
We confirm that to the best of our knowledge:
1. this interim condensed set of financial statements has been prepared
in accordance with UK adopted IAS 34 'Interim Financial Reporting';
2. the condensed set of financial statements has been prepared in
accordance with ASB's 2007 Statement Half-Yearly Reports;
3. the condensed set of financial statements give a true and fair view
of the asset, liabilities, financial position and profit or loss of the group
and the undertakings included in the consolidation as a whole as required by
DTR 4.2.4R; and
4. the interim management report includes a fair review of the
information required by:
4.1. DTR 4.2.7R of the Disclosure Guidance and Transparency Rules, being an
indication of important events that have occurred during the first six months
of the financial year and their impact on the condensed set of financial
statements; and a description of the principal risks and uncertainties for the
remaining six months of the year; and
4.2. DTR 4.2.8R of the Disclosure Guidance and Transparency Rules, being
related party transactions that have taken place in the first six months of
the current financial year and that have materially affected the financial
position or performance of the entity during that period; and any changes in
the related party transactions described in the last annual report that could
do so.
The directors of Nuformix plc are listed in the Group's 2022 Annual Report and
Accounts and the current board are set out on the Investors Information
section of Nuformix's website at: Investors Information - Nuformix
(https://nuformix.com/investors/investors-information/)
Dr Julian Gilbert
Non-Executive Chairman
12 December 2022
Further copies of this document are available from the company's registered
address and will be available on the company's website later today.
Nuformix plc
Registration number: 09632100
Nuformix plc
Registration number: 09632100
Unaudited Interim Results
Consolidated Income Statement and Statement of Comprehensive Income for the
six months ended 30 September 2022
6 months ending 30 September 6 months ending 30 September
Year ending 31 March
2022 2021 2022
Unaudited Unaudited Audited
Note £ £ £
Revenue - 50,000 50,000
Cost of sales - (1,695) (1,695)
Gross profit - 48,305 48,305
Total administrative expenses (423,677) (497,327) (1,318,577)
Other operating income - - -
Operating loss (423,677) (449,022) (1,270,272)
Finance costs - - -
Loss before tax (423,677) (449,022) (1,270,272)
Income tax receipt 1,163 - 161,279
Loss for the period and total comprehensive income for the period (422,514) (449,022) (1,108,993)
Loss per share - basic and diluted 4 0.06p 0.08p 0.19p
Nuformix plc
Registration number: 09632100
Unaudited Interim Results
Consolidated Statement of Financial Position as at 30 September 2022
30 September 30 September 31 March
2022 2021 2022
Note Unaudited Unaudited Audited
£ £ £
Assets
Non-current assets
Property, plant and equipment 5 177 698 438
Intangible assets 6 4,132,182 4,168,640 4,150,411
4,132,359 4,169,338 4,150,849
Current assets
Trade and other receivables 257,327 53,663 199,600
Income tax asset - 121,020 161,279
Cash and cash equivalents 389,840 1,071,831 464,095
647,167 1,246,514 824,974
Total assets 4,779,526 5,415,852 4,975,823
Equity and liabilities
Equity
Share capital 7 709,309 591,609 615,609
Share premium 6,671,253 6,384,835 6,500,817
Merger relief reserve 10,950,000 10,950,000 10,950,000
Reverse acquisition reserve (8,005,195) (8,005,195) (8,005,195)
Share option reserve 2,039,044 2,019,681 2,026,664
Retained earnings (7,772,447) (6,689,962) (7,349,933)
Total equity 4,591,964 5,250,968 4,737,962
Current liabilities
Trade and other payables 187,562 164,884 237,861
187,562 164,884 237,861
Total equity and liabilities 4,779,526 5,415,852 4,975,823
Nuformix plc
Unaudited Interim Results
Consolidated Statement of Changes in Equity for the six months ended 30
September 2022
Share capital Share premium Merger Relief Reverse acquisition Share option Retained earnings Total
£ £ Reserve reserve reserve £ £
£
At 31 March 2021 591,609 6,384,835 10,950,000 (8,005,195) 2,005,952 (6,240,940) 5,686,261
Loss for the half-year and total comprehensive income
- - - - - (449,022) (449,022)
Share and warrant based payment - - - - 13,729 - 13,729
As at 30 September 2021 591,609 6,384,835 10,950,000 (8,005,195) 2,019,681 (6,689,962) 5,250,968
Loss for the half-year and total comprehensive loss
- - - - - (659,971) (659,971)
Issue of share capital 24,000 145,982 - - - - 169,982
Share issue costs - (30,000) - - - - (30,000)
Share and warrant based payment - - - - 6,983 - 6,983
At 31 March 2022 615,609 6,500,817 10,950,000 (8,005,195) 2,026,664 (7,349,933) 4,737,962
Loss for the half-year and total comprehensive income
- - - - - (422,514) (422,514)
Issue of share capital 93,700 170,436 - - - - 264,136
Share and warrant based payment - - - - 12,380 - 12,380
As at 30 September 2022 709,309 6,671,253 10,950,000 (8,005,195) 2,039,044 (7,772,447) 4,591,964
Nuformix plc
Unaudited Interim Results
Consolidated Statement of Cash Flows for the six months ended 30 September
2022
6 months ending 30 September 6 months ending 30 September
Year Ended
31 March
2022 2021 2022
Unaudited Unaudited Audited
£ £ £
Cash flows from operating activities
Loss for the year (422,514) (449,022) (1,108,993)
Adjustments to cash flows from non-cash items
Depreciation and amortisation 18,489 18,488 36,976
Income tax expense - - (161,279)
Share and warrant based payment 12,380 13,729 20,712
(391,645) (416,805) (1,212,584)
Working capital adjustments
(Increase) decrease in trade and other receivables (58,888) (21,403) (167,340)
Increase (decrease) in trade and other payables (50,300) (159,740) (86,763)
Cash generated from operations (500,833) (597,948) (1,466,687)
Income taxes (paid)/received 162,442 121,020
Net cash flow from operating activities (338,391) (597,948) (1,345,667)
Cash flows from investing activities
Net cash flows from investing activities - - -
Cash flows from financing activities
Proceeds of share issue 264,136 - 139,982
Net cash flows from financing activities 264,136 - 139,982
Net (decrease)/increase in cash and cash equivalents (74,255) (597,948) (1,205,685)
Cash and cash equivalents at start of period 464,095 1,669,780 1,669,780
Cash and cash equivalents at end of period 389,840 1,071,832 464,095
Nuformix plc Unaudited Interim Results
Notes to the Consolidated Financial Statements for the six month ended 30
September 2022
1. Basis of preparation of interim financial information
The consolidated interim financial statements have been prepared in accordance
with the recognition and measurement principles of International Accounting
Standards as endorsed by the UK Endorsement Board ("IAS"), and are compliant
with IAS34 "Interim Financial Reporting."
The Group prepares its accounts in accordance with applicable UK Adopted
International Accounting Standards.
The accounting policies and methods of computation followed in the condensed
consolidated interim financial statements are the same as those applied in the
most recent annual report
The consolidated interim financial statements are unaudited and do not
constitute statutory accounts within the meaning of Section 434 of the
Companies Act 2006. Statutory accounts for the year ended 31 March 2022,
prepared in accordance with IAS, have been filed with the Registrar of
Companies. The Auditors' Report on these accounts was unqualified and included
a reference to which the Auditors drew attention by way of an emphasis of
matter, without qualifying their report, that a material uncertainty existed
that might cast significant doubt on the Group's ability to continue as a
going concern at that time. The Auditors' Report did not contain any
statements under section 498 of the Companies Act 2006.
The condensed consolidated interim financial statements are for the 6 months
to 30 September 2022.
The condensed consolidated interim financial information does not include all
the information and disclosures required in the annual financial statements,
and should be read in conjunction with the group's annual financial statements
for the year ended 31 March 2022, which were prepared in accordance with UK
adopted International Accounting Standards ("IFRSs"). As explained above,
although this was a different accounting framework, there is no impact on
recognition, measurement or disclosure.
2. Basis of consolidation
On 16 October 2017 the Company acquired the entire issued ordinary share
capital of Nuformix Technologies Limited and became the legal parent of
Nuformix Technologies Limited. The accounting policy adopted by the Directors
applies the principles of IFRS 3 (Revised) "Business Combinations" in
identifying the accounting parent as Nuformix Technologies Limited and the
presentation of the Group consolidated statements of the Company (the legal
parent) as a continuation of financial statements of the accounting parent or
legal subsidiary (Nuformix Technologies Limited).
3. Going concern
The consolidated interim financial statements have been prepared on the going
concern basis of preparation which, inter alia, is based on the directors'
reasonable expectation that the Group has adequate resources to continue to
operate as a going concern for at least twelve months from the date of their
approval. In forming this assessment, the directors have prepared cashflow
forecasts covering the period ending 31 March 2024 which take into account the
likely run rate on overheads and planned research expenditure and the
expectations of a further fundraise to be completed in H1-23.
Whilst there can be no guarantee of the successful outcome of future studies,
in compiling the cashflow forecasts the directors have made cautious estimates
of the likely outcome of such studies, when a fundraise may complete and have
considered alternative strategies should projected funding be delayed or fail
to materialise. These strategies include postponing non-committed research
expenditure, securing alternative licensing arrangements from those currently
planned and additional corporate activity to support the business.
These circumstances indicate the existence of a material uncertainty which may
cast significant doubt on the Group's ability to continue as a going
concern. The consolidated interim financial statements do not include any
adjustments that would result if the company or Group was unable to continue
as a going concern.
After careful consideration, the directors consider that they have reasonable
grounds to believe that the Group can be regarded as a going concern and, for
this reason, they continue to adopt the going concern basis in preparing the
consolidated interim financial statements.
4 Loss per Share
Loss per share is calculated by dividing the loss after tax attributable to
the equity holders of the Group by the weighted average number of shares in
issue during the period.
The basic earnings per share for each comparative period is calculated by
dividing the loss in each of those periods by the legal entity's historical
weighted average number of shares outstanding.
30 September 30 September 31 March
2022 2021 2022
Unaudited Unaudited Audited
£ £ £
Loss after tax (422,514) (449,022) (1,108,993)
Weighted average number of shares 707,261,281 591,609,368 598,447,724
Basic and diluted loss per share 0.06p 0.08p 0.19p
5 Property, Plant and Equipment
Computer equipment
Total
£ £
Cost or valuation
At 31 March 2021 1,561 1,561
At 30 September 2021 1,561 1,561
At 31 March 2022 1,561 1,561
At 30 September 2022 1,561 1,561
Depreciation
At 31 March 2021 604 604
Charge 259 259
At 30 September 2021 863 863
Charge 260 260
At 31 March 2022 1,123 1,123
Charge 261 261
At 30 September 2022 1,384 1,384
Carrying amount
At 30 September 2021 698 698
At 31 March 2022 438 438
At 30 September 2022 177 177
6 Intangible Assets
Goodwill Patents Total
£ £ £
Cost
At 31 March 2021 4,023,484 449,611 4,473,095
At 30 September 2021 4,023,484 449,611 4,473,095
Written Off - (85,035) (85,035)
At 31 March 2022 4,023,484 364,576 4,388,060
At 30 September 2022 4,023,484 364,576 4,388,060
Amortisation
At 31 March
2021
- 286,227 286,227
Amortisation
charge
- 18,228 18,228
At 30 September
2021
- 304,455 304,455
Amortisation
charge
- 18,229 18,229
On Written
Off
- (85,035) (85,035)
At 31 March
2022
- 237,649 237,649
Amortisation charge
- 18,229 18,229
At 30 September 2022 -
255,878 255,878
Net book value
At 30 September 2021 4,023,484 145,156
4,168,640
At 31 March 2022 4,023,484 126,927
4,150,411
At 30 September 2022 4,023,484 108,698
4,132,182
For impairment testing purposes, management consider the operations of the
Group to represent a single cash-generating unit ("CGU") focused on research
and development. Consequently, the goodwill is effectively allocated and
considered for impairment against the business as a whole being the single
CGU.
7 Share Capital
Allotted, called up and fully paid shares
30 September 30 September 31 March
2022 2021 2022
Unaudited Unaudited Audited
No. £ No. £ No. £
Ordinary shares of £0.001 each 709,309,368 709,309 591,609,368 591,609 615,609,368 615,609
On 4 April 2022, the company completed a capital increase through the issue of
93,700,000 shares of £0.001 each in a share placement at a price of £0.015
per share. The Share Premium arising has been calculated in line with the
Sharing Agreement with Lanstead Capital Partners LP ("Lanstead") as outlined
below.
In December 2021 the Company entered into a Sharing Agreement with Lanstead,
split into two tranches of new shares issued with payments to be received over
a 20-month period from March 2022 to October 2023.
The agreement is structured in such a way that the proceeds received by the
Company are linked to the market price for the Company's shares. The proceeds
are calculated based on the volume-weighted average share price in the month
preceding the payment from Lanstead, compared to a target price of 2p per
share. Based on historic share prices, and a valuation as at the latest
available price the total proceeds from Tranche 2 (issued in April 2022) are
expected to be £264,136 (including Share Premium of £170,436), of which
£206,609 has been recognized in debtors.
8 Share Options and Warrants
The Group operates share-based payments arrangements to remunerate directors
and key employees in the form of a share option scheme. Equity-settled
share-based payments are measured at fair value (excluding the effect of
non-market-based vesting conditions) at the date of grant. The fair value
determined at the grant date of the equity-settled, share-based payments and
is expensed on a straight-line basis over the vesting period, based on the
Group's estimate of shares that will eventually vest and adjusted for the
effect of non-market based vesting conditions.
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