REG - Nuformix PLC - Half-year Report
18/06/2024 07:00
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RNS Number : 7742S Nuformix PLC 18 June 2024
Nuformix plc
("Nuformix", the "Company" or the "Group")
Half Year Report
18 June 2024: 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 31 March 2024.
Operational highlights (including post-period end)
· The Board continues to be encouraged by the positive data generated
to date on NXP002 in context to the evolving treatment landscape and
understanding of future patient needs in the treatment of fibrosing
interstitial lung diseases. Preliminary discussions have been initiated with
potential partners and are on-going.
· Notice of Allowance was received for the Japanese National Phase
Patent Application No. 2020-555115 for NXP002 entitled "CRYSTALLINE TRANILAST
SALTS AND THEIR PHARMACEUTICAL USE" which has now formally granted. Notice of
Allowance has also been received from the European Patent Office for the
European National Phase Application, with formal granting complete. This
patent describes proprietary new forms of tranilast being progressed by the
Company as NXP002 as a potential novel idiopathic pulmonary fibrosis ("IPF")
treatment. These proprietary drug forms uniquely enable drug delivery via an
inhaled nebulised formulation.
· Just prior to the beginning of the period, on 18 September 2023, the
Company announced that Oxilio had acquired ownership of its NXP001 patent
estate for which Nuformix received new immediate and near-term undisclosed
milestone payments, whilst retaining further development milestones and
royalties capped at £2 million per year.
· During the period the Company received proceeds from the Company's
subscription and associated sharing arrangements with Lanstead Capital
Investors L.P. ("Lanstead"). The sharing agreements ended in October 2023,
concluding this arrangement and the Company is due no further funds from
Lanstead.
· A subscription for 75,000,000 new ordinary shares at a price of 0.20
pence per share raised gross proceeds of £150,000, representing approximately
9.2 per cent. of the Company's enlarged issued share capital.
Financial Highlights
· Loss before tax of £242,529 (31 March 2023: loss of £337,622)
· Loss on ordinary activities (after tax credit) of £242,529 (31 March
2023: loss of £337,622)
· Loss per share 0.03p (31 March 2023: 0.05p)
· Net assets of £4,102,051 (31 March 2023: £4,228,204) including
£183,523 of cash and cash equivalents at 31 March 2024 (31 March 2023:
£259,259)
Dr Dan Gooding, Executive Director of Nuformix, said: "Our research efforts
and external discussions to date demonstrate that inhaled treatment of IPF and
related fibrotic lung diseases via NXP002 is a viable and attractive concept.
We remain focused on generating data and initiating, and further developing,
discussions with potential partners that will support our efforts to secure
out-license deals on NXP002 and NXP004. Progression of these opportunities 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
Bob Pountney (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 Group aim use its expertise
in discovering, patenting and subsequently developing and novel drug forms
with improved physical properties, to develop new product opportunities that
are differentiated from the original product (by way of dose, delivery route
or presentation), thus creating new and attractive commercial opportunities.
Nuformix has an early-stage pipeline of preclinical 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 (novel proprietary forms of tranilast): Interstitial Lung Diseases
("ILDs") including Idiopathic Pulmonary Fibrosis ("IPF") and Progressive
Pulmonary Fibrosis ("PPF")
NXP002 is the Group's preclinical lead asset and a potential novel inhaled
treatment for IPF and PPF and possibly other fibrosing ILDs. NXP002 is a
proprietary, new form of the drug tranilast. NXP002's enhanced physical
property profile uniquely delivery to the lung in an inhaled, smart nebuliser
formulation.
There are more than 200 types of interstitial lung diseases ("ILD"), which are
characterised by varied amounts of inflammation, scarring, or both, that
damage the lung's ability to absorb oxygen. IPF is the most well-known form of
ILD, affecting approximately 100,000 patients per year in the US. Progressive
Pulmonary Fibrosis (PPF), previously referred to as Progressive Fibrosing ILD
(PF-ILD), is a larger and even more poorly served segment of the ILD market,
affecting more than 200k patients per year in the US.
IPF and PPF are devastating lung diseases associated with a higher mortality
rate than many cancers with median survival of 3-5 years. Thus, IPF and PPF
represent a high unmet medical need such that the requirement for improved
treatment options represents 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 ("SoC")
therapies OFEV and Esbriet (now off patent) achieved US$3.5bn and US$0.8bn
respectively in 2022.
Tranilast has a long history of safe use as an oral drug for asthma, keloids
and hypertrophic scarring, but while there is growing evidence that supports
its potential use in other fibrotic conditions, including IPF, a combination
of poor physicochemical properties, variable pharmacokinetics and challenging
pharmacodynamics following oral delivery limit its potential use in ILDs.
NXP002 is differentiated as it is a patent protected, novel form of tranilast
that has been optimised for formulation and delivery direct to the lungs by
inhalation, potentially overcoming the issues using tranilast orally as a
chronic treatment for ILDs.
NXP002 as a potential treatment for IPF, is a likely candidate for Orphan Drug
Designation, which could provide additional product protection against
potential future competitors in addition to product development advantages.
The inhalation route is a well-known strategy for the treatment of lung
diseases to yield greater efficacy and reduce systemic, off-target
side-effects compared to oral treatment. Discontinuation of treatment in IPF
and PPF patients is currently an issue in the treatment of these diseases with
discontinuation rates for current SoCs up to 80% in certain patient groups due
to their debilitating systemic side-effects. Effective inhalation therapies
offer the potential to overcome these limitations of oral therapies.
The positioning of NXP002 as an inhaled treatment for IPF and PPF could be
either as added to SoC treatments or administered as a monotherapy for
patients non-responsive to SoCs and those declining these therapies due to
side effects which impact quality of life.
The Group's pre-clinical inhalation development strategy has significantly
progressed NXP002 towards validation of its Target Product Profile ("TPP")
demonstrating:
• NXP002 can be delivered in-vivo by a range of nebulisers at the optimum
particle size for delivery to the deep lung;
• 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 ex-vivo human IPF tissue studies
to date.
The Group conducted studies in a new iteration of a 3D human IPF lung tissue
using a disease and species relevant model that has been advanced to
significantly reduce output variability. The results from these studies of
NXP002 alone and in combination with current SoCs, can be summarised as
follows:
• NXP002 is well tolerated in ex-vivo human lung tissue with no signs of
toxicity events;
• NXP002 alone delivers a strong, consistent anti-fibrotic and
anti-inflammatory effect as demonstrated by modulation of the release of
multiple biomarkers of fibrosis and inflammation;
• both high and low concentrations of NXP002 show an additive anti-fibrotic
and anti-inflammatory effect to SoC;
• in particular, the higher concentrations of NXP002 with SoC's deliver a
near complete ablation of fibrosis biomarker release, yet at lower
concentrations than have been seen in other preclinical models to date; and
• the clear, pronounced additive benefit of NXP002 on top of SoCs observed
suggests that NXP002 may provide additional efficacy, even in patients
responding to SoC therapy.
This raises the possibility that NXP002 targets additional disease pathways to
SoC's when increasing the combined anti-fibrotic and anti-inflammatory
response. Following success in suppressing biomarkers of fibrotic disease
progression in human IPF lung tissue, the same samples were analysed to assess
additional mechanistic and anti-inflammatory benefits on top of SoC's and the
results are summarised as follows:
• NXP002 alone delivers a strong, consistent anti-inflammatory effect as
demonstrated by suppression of the release of inflammatory cytokines by over
90% for all cytokines studied; and
• the results further suggest that NXP002 may provide additional efficacy in
combination with SoC's, even in patients not responding to SoC therapy alone.
Nuformix's TPP for NXP002 seeks twice daily inhalation administration. To
assess NXP002's duration of action, the Group initiated work in an exploratory
model in healthy human lung tissue. The model also bridges the Group's
successful preclinical work across a variety of LPS-challenge studies. The
results are summarised as follows:
• NXP002 suppresses the release of inflammatory cytokines by healthy human
lung tissue following LPS challenge; and
• an anti-inflammatory effect remains at 12 hours post drug dosing
demonstrated by continued suppression of the release of inflammatory cytokines
following LPS challenge, confirming NXP002 has a duration of action that may
support twice daily dosing.
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 to the programme and
support on-going licensing activities.
NXP004 (novel forms of olaparib) - Oncology
The Group discovered novel forms of olaparib, a drug currently marketed by
AstraZeneca, as 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$2.6bn
in 2022 with industry analysts forecasting annual sales of US$9.7bn by 2028.
Subsequently, further preformulation and in-vitro studies allowed Nuformix to
identify lead cocrystals to be progressed for further development. Results
from in vitro dissolution studies demonstrated that the two lead NXP004
cocrystals out-performed Lynparza(®), both in terms of rate and extent of
dissolution and release of olaparib.
Enhancement of dissolution in the currently marketed formulation of
Lynparza(®) resulted in improved bioavailability versus the initial marketed
product. Therefore, NXP004 may offer potential to further increase olaparib's
bioavailability. In addition, the potential simplicity of NXP004-based
formulations may offer improvements in product cost-of-goods versus the
currently marketed product, which requires complex manufacturing methods.
These attributes position NXP004 for applications in line-extensions for the
currently marketed product, or for possible development in future
first-to-generic product opportunities. 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) initially exclusively licensed to Oxilio Limited
("Oxilio") for oncology indications. Oxilio has now acquired ownership of
Nuformix's NXP001 patent estate. Nuformix retained rights to receive further
development milestones and royalties capped at £2 million per year under the
terms of the acquisition.
Outlook
The Company continues to advance and exploit the current assets within the
portfolio through the R&D and business development activities as set out
above.
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
18 June 2024
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 2023 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
18 June 2024
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 31 March 2024
6 months ending 31 March 6 months ending 31 March 18 months ending 30 September
2024 2023 2023
Unaudited Unaudited Audited
Note £ £ £
Revenue - - -
Cost of sales - - -
Gross profit - - -
Total administrative expenses (242,529) (337,622) (927,972)
Other operating income - - -
Operating loss (242,529) (337,622) (927,972)
Finance costs - - -
Loss before tax (242,529) (337,622) (927,972)
Income tax receipt - - 68,505
Loss for the period and total comprehensive income for the period (242,529) (337,622) (859,467)
Loss per share - basic and diluted 4 0.03p 0.05p 0.12p
Nuformix plc Registration number: 09632100
Unaudited Interim Results
Consolidated Statement of Financial Position as at 31 March 2024
31 March 31 March 30 September
2024 2023 2023
Note Unaudited Unaudited Audited
£ £ £
Assets
Non-current assets
Property, plant and equipment 5 - - -
Intangible assets 6 4,072,770 4,113,953 4,081,277
4,072,770 4,113,953 4,081,277
Current assets
Trade and other receivables 31,136 128,547 66,857
Income tax asset 67,342 - 67,342
Cash and cash equivalents 183,522 259,259 202,548
282,000 387,806 336,747
Total assets 4,354,770 4,501,759 4,418,024
Equity and liabilities
Equity
Share capital 7 819,309 709,309 744,309
Share premium 6,731,348 6,635,378 6,656,802
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 2,058,518 2,048,781 2,058,518
Retained earnings (8,451,929) (8,110,069) (8,209,400)
Total equity 4,102,051 4,228,204 4,195,034
Current liabilities
Trade and other payables 252,719 273,555 222,990
252,719 273,555 222,990
Total equity and liabilities 4,354,770 4,501,759 4,418,024
Nuformix plc
Unaudited Interim Results
Consolidated Statement of Changes in Equity for the six months ended 31 March
2024
Share capital Share premium Merger Relief Reverse acquisition Share option Retained earnings Total
£ £ Reserve reserve reserve £ £
£
At 30 September 2022 709,309 6,671,253 10,950,000 (8,005,195) 2,039,044 (7,772,447) 4,591,964
Loss for the half-year and total comprehensive income - - - - - (337,622) (337,622)
Issue of share capital - (35,875) - - - - (35,875)
Share and warrant based payment - - - - 9,737 - 9,737
As at 31 March 2023 709,309 6,635,378 10,950,000 (8,005,195) 2,048,781 (8,110,069) 4,228,204
Loss for the half-year and total comprehensive loss - - - - - (99,331) (99,331)
Issue of share capital 35,000 25,724 - - - - 60,724
Share issue costs - (4,300) - - - - (4,300)
Share and warrant based payment - - - - 9,737 - 9,737
At 30 September 2023 744,309 6,656,802 10,950,000 (8,005,195) 2,058,518 (8,209,400) 4,195,034
Loss for the half-year and total comprehensive income - - - - - (242,529) (242,529)
Issue of share capital 75,000 74,546 - - - - 149,546
Share and warrant based payment - - - - - - -
As at 31 March 2024 819,309 6,731,348 10,950,000 (8,005,195) 2,058,518 (8,451,929) 4,102,051
Nuformix plc
Unaudited Interim Results
Consolidated Statement of Cash Flows for the six months ended 31 March 2024
6 months ending 31 March 6 months ending 31 March 18 months ending 30 September
2024 2023 2023
Unaudited Unaudited Audited
£ £ £
Cash flows from operating activities
Loss for the year (242,529) (337,622) (859,467)
Adjustments to cash flows from non-cash items:
Profit on sale of intangibles - - (35,552)
Depreciation and amortisation 8,507 18,406 55,124
Income tax expense - - (68,505)
Share and warrant based payment - 9,737 31,854
(234,022) (309,479) (876,546)
Working capital adjustments
(Increase) decrease in trade and other receivables 35,721 128,779 132,742
Increase (decrease) in trade and other payables 29,729 85,994 (14,870)
Cash generated from operations (168,572) (94,706) (758,674)
Income taxes (paid)/received - - 162,442
Net cash flow from operating activities (168,572) (94,706) (596,232)
Cash flows from investing activities
Proceeds from sale of intangibles - - 50,000
Net cash flows from investing activities - - 50,000
Cash flows from financing activities
Proceeds of share issue 149,546 (35,875) 284,685
Net cash flows from financing activities 149,546 (35,875) 284,685
Net (decrease)/increase in cash and cash equivalents (19,026) (130,581) (261,547)
Cash and cash equivalents at start of period 202,548 389,840 464,095
Cash and cash equivalents at end of period 183,522 259,259 202,548
Nuformix plc
Unaudited Interim Results
Notes to the Consolidated Financial Statements for the six months ended 31
March 2024
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 30 September 2023,
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 31 March 2024.
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 30 September 2023, 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 December 2025 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 H2 2024.
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.
31 March 31 March 30 September
2024 2023 2023
Unaudited Unaudited Audited
£ £ £
Loss after tax (242,529) (337,622) (859,467)
Weighted average number of shares 756,945,238 709,309,368 719,462,470
Basic and diluted loss per share (0.03)p (0.05)p (0.12)p
5 Property, Plant and Equipment
Computer equipment
Total
£ £
Cost or valuation
At 30 September 2022 1,561 1,561
At 31 March 2023 1,561 1,561
Disposals (1,561) (1,561)
At 30 September 2023 - -
At 31 March 2024 - -
Depreciation
At 30 September 2022 1,385 1,385
Charge 176 176
At 31 March 2023 1,561 1,561
On Disposals (1,561) (1,561)
At 30 September 2023 - -
At 31 March 2024 - -
Carrying amount
At 31 March 2023 - -
At 30 September 2023 - -
At 31 March 2024 - -
6 Intangible Assets
Goodwill Patents Total
£ £ £
Cost
At 30 September 2022 4,023,484 364,576 4,388,060
At 31 March 2023 4,023,484 364,576 4,388,060
Disposals - (72,915) (72,915)
At 30 September 2023 4,023,484 291,661 4,315,145
At 31 March 2024 4,023,484 291,661 4,315,145
Amortisation
At 30 September 2022 - 255,878 255,878
Amortisation charge - 18,229 18,229
At 31 March 2023 - 274,107 274,107
Amortisation charge - 18,228 18,228
On Written Off (58,467) (58,467)
At 30 September 2023 - 233,868 233,868
Amortisation charge - 8,507 8,507
At 31 March 2024 - 242,375 242,375
Net book value
At 31 March 2023 4,023,484 90,469 4,113,953
At 30 September 2023 4,023,484 57,793 4,081,277
At 31 March 2024 4,023,484 49,286 4,072,770
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
31 March 31 March 30 September
2024 2023 2023
Unaudited Unaudited Audited
No. £ No. £ No. £
Ordinary shares of £0.001 each 819,309,368 819,309 709,309,368 709,309 744,309,368 744,309
On 1 March 2024, the company completed a capital increase through the issue of
75,000,000 shares of £0.001 each in a share placement at a price of £0.002
per share.
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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