REG - Nuformix PLC - Half year Report
14/12/2021 07:00
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RNS Number : 5107V Nuformix PLC 14 December 2021
Nuformix plc
("Nuformix", the "Company" or the "Group")
Half year Report
14 December 2021: 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 2021.
Operational highlights (including post-period end)
● Gross proceeds of £1.565 million (net £1.4 million) raised from the placing
of new ordinary shares in March 2021 have been used to fund R&D work to
advance the pipeline assets of NXP002 (pre-clinical stage) and NXP004
(research phase)
● Successfully performed a number of pre-clinical studies on NXP002, which is
the lead asset being developed for the treatment of Idiopathic Pulmonary
Fibrosis ("IPF"), to generate a robust data package. Studies on the technical
feasibility of inhalation and the pharmacokinetic / pharmacodynamic profile of
NXP002 after inhalation in the rat have, in the opinion of the Company's
Directors, been positive to date and endorse the further progression of this
asset. The final study in the data package on the durability of the
pharmacodynamic response is expected to readout in early 2022
● NXP002 patent application granted in the USA, which is the most important
territory for IPF
● Filed a US patent application on 10 November 2021 in relation to NXP004, that
represents new forms of a blockbuster oncology drug, which has identified a
new family of co-crystals with benefits over the original drug
● Licensing agreement signed with Oxilio Ltd on 10 September 2021 for the
development and commercialisation of NXP001 for oncology indications
● Leadership team enhanced with the appointment of Dr Alastair Riddell as
Non-Executive Chairman (with post-period appointment as Executive Chairman
from 1 December 2021), who brings significant pharma and biotech experience in
R&D, corporate development and general leadership
● Dr Anne Brindley (CEO) resigned in July 2021 and will be leaving the Company
at the end of her six-month notice period. Dr Joanne Holland resigned as a
director and left the Company as an employee at the end of May 2021 but has
continued as a consultant advising on physical form science and research
Financial Highlights
● Total revenue of £50,000 (30 September 2020: £195,550)
● Loss before tax £449,022 (30 September 2020: loss of £475,874)
● Loss on ordinary activities (after tax credit) of £449,022 (30 September
2020: loss of £474,659)
● Loss per share 0.08p (30 September 2020: 0.10p)
● Net assets of £5,250,968 (30 September 2020: £4,301,236) including
£1,071,831 of cash and cash equivalents (30 September 2020: £216,412)
Dr Alastair Riddell, Executive Chairman of Nuformix, said: "The new positive
data sets on NXP002, patent progress on NXP004 and the licensing deal for
NXP001 form the basis for further value creation in the next 12 months. Both
our current lead assets address billion-dollar markets in fibrosis and
oncology. The results have given the Board the confidence to progress further
work on our products and investment in additional business development
resource for the Company."
Dr Anne Brindley, CEO of Nuformix, said: "We have made significant progress
on all three of our assets including successfully completed the licensing deal
for NXP001 with Oxilio, as well as significantly advancing the data package on
NXP002 that has shown positive data to date and filing a new patent
application on NXP004. We have achieved this with very prudent use of funds
ensuring the Company is on a firm financial footing for the foreseeable
future. Although regretfully I am moving on from Nuformix, I remain very
optimistic that Nuformix has assets of value that the Group can advance to
further develop the company and I wish the Board and the company much success
in these endeavours."
Enquiries:
Nuformix plc via Walbrook
Dr Alastair Riddell, Executive Chairman
Dr Anne Brindley, CEO
Allenby Capital Limited +44 (0) 20 3328 5656
Nick Athanas / George Payne (Corporate Finance)
Stefano Aquilino / Matt Butlin (Sales and Corporate Broking)
Walbrook PR nuformix@walbrookpr.com or
+44 (0)20 7933 8780
Anna Dunphy / Phillip Marriage Tel: +44 (0)7876 741 001 /
+44 (0)7867 984 082
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 an early-stage pipeline of preclinical and Phase
1-ready 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/) .
Executive 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. 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. 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 filed two patent applications on new forms of
tranilast, one of which is granted globally and a second has been issued
(granted) in the USA. The positioning of such an inhaled treatment for IPF
could be either added to standard of care or administered as a monotherapy.
Within the last six months, since the fundraise in March 2021, the Group has
utilised these proceeds to generate a robust data package with the goal of
increasing the value of this asset and rendering it more attractive to
licensing partners. The Company has successfully progressed studies on NXP002
as follows:
● Manufactured a supply of the active ingredient NXP002 to be used in
formulation development activities, nebulisation feasibility studies and in
vivo studies
● Progressed formulation and nebulisation studies and demonstrated that it is
feasible to formulate NXP002 into a simple and stable solution which has
suitable properties for delivery via nebulisation. The data generated on these
formulations also show that the drug can be efficiently delivered in the right
particle size range for lung delivery using off-the-shelf and commonly used
nebuliser devices. Thus, the Directors of the Company believe that the
delivery of NXP002 by nebulisation is feasible
● Progressed several in vivo pharmacokinetic and pharmacodynamic studies of
NXP002 formulated as a solution for inhalation (nebulisation) and delivered to
the rat
○ The first of the in vivo studies evaluated the pharmacokinetics of NXP002 when
delivered by nebulisation to rats. This study demonstrated that NXP002 can be
efficiently delivered to the lung, achieving significant drug levels, whilst
limiting systemic exposure compared to oral dosing
○ The second in vivo study evaluated the pharmacodynamics of NXP002 when
delivered by nebulisation. This study showed that inhaled NXP002 could
dose-dependently regulate the production of fibrosis-relevant mediators
● The final planned study as part of the NXP002 pre-clinical data package is an
in vivo study investigating the durability of the pharmacodynamic effect. This
study is ongoing and the Company anticipates receiving the data for this study
in early 2022.
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.
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). A disadvantage of aprepitant is that its
sub-optimal properties necessitate a complex formulation. The Group has
discovered new forms of aprepitant (NXP001) with improved properties and it
has been granted patents on these new forms. Literature data suggests that
aprepitant could have benefits in oncology, i.e., beyond the currently
marketed indications.
To date, the Group has conducted preclinical studies and a Phase 1 study,
which demonstrated bioavailability of NXP001, similar to the marketed product
but without requiring a complex formulation. Further refinement of the
formulation will be required ahead of initiating any future Phase 1 studies.
On 23 September 2020, Oxilio, a privately held pharmaceutical development
company, was granted a six-month option to license NXP001 globally for
repurposing in oncology. On 23 March 2021, Oxilio exercised the option and on
10 September 2021 a global license deal was executed. As a result, Nuformix
has licensed its patent estate and know-how on NXP001 in return for an upfront
payment, development milestones and a royalty on net sales, capped at £2
million per annum.
NXP004 (new forms of undisclosed drug) - Oncology
The Group has discovered novel forms of an undisclosed marketed oncology drug
that is approved globally for the treatment of several cancers, which has
significant sales (more than £1 billion per annum in 2020) and is showing
further sales growth. The Group filed one patent application in September 2020
on new forms of this drug and has utilised certain of the proceeds from the
March 2021 placing to do further research on novel forms. This research has
been successful, identifying a new family of co-crystal forms and on 10
November 2021, post period, the Company filed a second patent application.
This application complements the previous patent application on NXP004
co-crystals, thus expanding the Company's intellectual property portfolio. If
the patent applications on these new forms are granted, there is potential for
patent expiry to extend to 2040/2041. The Group will seek to license NXP004 to
the originator of the marketed drug to potentially extend their patent
protection, thus potentially adding significant value for the originator.
Board changes
In the period from April 2021 to September 2021 a number of Board changes have
occurred:
● May 2021 - appointment of Dr Alastair Riddell as Non-Executive Chairman,
replacing Dr Chris Blackwell who resigned in February 2021
● May 2021 - resignation of Dr Karl Keegan as Non-Executive Director
● May 2021 - resignation of Dr Joanne Holland as Chief Scientific Officer;
however, Joanne remains a consultant to Nuformix and is supporting physical
form research and science on Nuformix assets
● July 2021 - resignation of Dr Anne Brindley as CEO. Anne has continued to work
for the Company through her six-month notice period
On 1 December 2021 Dr Alastair Riddell was appointed as Executive Chairman to
ensure there is a suitable executive in place for when Anne Brindley leaves
the Company.
Outlook
The success of the fundraise earlier in the year has enabled the Company to
continue to advance and exploit the current assets within the portfolio
through additional R&D and business development activities as set out
above. R&D studies have progressed successfully on both NXP002 and NXP004,
while business development activities secured the license agreement for NXP001
and therefore good progress has been made on all fronts. Moreover, the
successful fundraise has provided a good cash runway for the Company to fund
limited operations for the foreseeable future.
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. The positive data
from the R&D studies performed in the last six months has increased the
Board's confidence that the Nuformix assets have significant value and thus
further investment in and progression of these assets are warranted.
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. Revenue was received from the second instalment of the
upfront payment from Oxilio on execution of the full licensing agreement for
NXP001.
Dr Alastair Riddell
Executive Chairman
14 December 2021
Nuformix plc
Unaudited Interim Results
Consolidated Income Statement and Statement of Comprehensive Income for the
six months ended 30 September 2021
6 months ending 30 September 6 months ending 30 September
Year ending 31 March
2021 2020 2021
Unaudited Unaudited Audited
Note £ £ £
Revenue 50,000 195,550 195,550
Cost of sales (1,695) (115,507) (62,307)
Gross profit 48,305 80,043 133,243
Total administrative expenses (497,327) (554,822) (1,507,221)
Other operating income - 1,300 1,300
Operating loss (449,022) (473,479) (1,372,678)
Finance costs - (2,395) (3,054)
Loss before tax (449,022) (475,874) (1,375,732)
Income tax receipt - 1,215 122,235
Loss for the period and total comprehensive income for the period (449,022) (474,659) (1,253,497)
Loss per share - basic and diluted 4 0.08p 0.10p 0.22p
Nuformix plc
Registration number: 09632100
Unaudited Interim Results
Consolidated Statement of Financial Position as at 30 September 2021
30 September 30 September 31 March
2021 2020 2021
Note Unaudited Unaudited Audited
£ £ £
Assets
Non-current assets
Property, plant and equipment 5 698 64,661 957
Intangible assets 6 4,168,640 4,225,381 4,186,868
4,169,338 4,290,042 4,187,825
Current assets
Trade and other receivables 53,663 88,956 32,260
Income tax asset 121,020 - 121,020
Cash and cash equivalents 1,071,831 216,411 1,669,780
1,246,514 305,368 1,823,060
Total assets 5,415,852 4,595,410 6,010,885
Equity and liabilities
Equity
Share capital 7 591,609 490,145 591,609
Share premium 6,384,835 4,480,400 6,384,835
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 2,019,681 1,847,988 2,005,952
Retained earnings (6,689,962) (5,462,102) (6,240,940)
Total equity 5,250,968 4,301,236 5,686,261
Current liabilities
Trade and other payables 164,884 243,846 324,624
Loans and borrowings 0 50,328 0
164,884 294,174 324,624
Total equity and liabilities 5,415,852 4,595,410 6,010,885
Nuformix plc
Unaudited Interim Results
Consolidated Statement of Changes in Equity for the six months ended 30
September 2021
Share capital Share premium Merger Relief Reverse acquisition Share option Retained earnings Total
£ £ Reserve reserve reserve £ £
£
£
At 31 March 2020 490,145 4,480,400 10,950,000 (8,005,195) 1,814,613 (4,987,443) 4,742,520
Loss for the half-year and total - - - - - (474,659) (474,659)
comprehensive loss
Issue of share capital - - - - - - -
Share and warrant based payment 33,375 33,375
As at 30 September 2020 490,145 4,480,400 10,950,000 (8,005,195) 1,847,988 (5,462,102) 4,301,236
Loss for the half-year and total comprehensive loss
- - - - - (778,838) (778,838)
Issue of share capital 101,464 2,113,535 - - - - 2,214,999
Share issue costs (209,100) (209,100)
Share and warrant based payment - - - - 157,964 - 157,964
-
- - - - - -
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
Nuformix plc
Unaudited Interim Results
Consolidated Statement of Cash Flows for the six months ended 30 September
2021
6 months ending 30 September 6 months ending 30 September
Year Ended
31 March
2021 2020 2021
Unaudited Unaudited Audited
£ £ £
Cash flows from operating activities
Loss for the year (449,022) (474,659) (1,253,497)
Adjustments to cash flows from non-cash items
Depreciation and amortisation 18,488 41,337 93,052
Loss on disposal of plant, property and equipment - - 6,179
Finance costs/ (income) - 2,395 3,054
Income tax expense - - (122,235)
Share and warrant based payment 13,729 33,375 191,339
(416,805) (397,552) (1,082,108)
Working capital adjustments
(Increase) decrease in trade and other receivables (21,403) (9,460) 47,237
Increase (decrease) in trade and other payables (159,740) (89,739) 16,099
Cash generated from operations (597,948) (496,751) (1,018,772)
Income taxes (paid)/received 172,391 173,606
Net cash flow from operating activities (597,948) (324,360) (845,166)
Cash flows from investing activities
Acquisitions of property plant and equipment - (605) (605)
Disposals of property plant and equipment - - 44,322
Net cash flows from investing activities - (605) 43,717
Cash flows from financing activities
Proceeds of share issue - - 2,005,899
Interest paid (2,395) (3,054)
Reduction in other loans - - (75,388)
Net cash flows from financing activities - (2,395) 1,927,457
Net (decrease)/increase in cash and cash equivalents (597,948) (327,360) 1,126,008
Cash and cash equivalents at start of period 1,669,780 543,772 543,772
Cash and cash equivalents at end of period 1,071,832 216,412 1,669,780
Nuformix plc
Unaudited Interim Results
Notes to the Consolidated Financial Statements for the six months ended 30
September 2021
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").
On 31 December 2020, IFRS as adopted by the European Union at that date was
brought into UK law and became UK-adopted International Accounting Standards,
with future changes being subject to endorsement by the UK Endorsement Board.
The Group transitioned to UK-adopted International Accounting Standards in its
consolidated financial statements on 1 April 2021. Whilst this change
constitutes a change in accounting framework, there is no impact on
recognition, measurement or disclosure.
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 2021,
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 consolidated interim financial statements are for the 6 months to 30
September 2021.
The 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 2021, which were prepared in
accordance with IFRS as adopted by the European Union. 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
2023 which take into account the likely run rate on overheads and research expenditure
and the prudent expectations of income from its lead programmes.
Whilst there can be no guarantee of the successful outcome of future trials,
in compiling the cashflow forecasts the directors have made cautious estimates
of the likely outcome of such trials, when income might be generated and have
considered alternative strategies should projected income be delayed or fail
to materialise. These strategies include postponing non-committed research
expenditure, securing alternative licensing arrangements from those currently
planned and using the Group's established network for fundraising.
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
2021 2020 2021
Unaudited Unaudited Audited
£ £ £
Loss after tax (449,022) (474,659) (1,253,497)
Weighted average number of shares 591,609,368 490,145,083 580,629,372
Basic and diluted loss per share 0.08p 0.10p 0.22p
5. Property, Plant and Equipment
Leasehold improvements Computer equipment Laboratory equipment
Total
£ £ £ £
Cost or valuation
At 31 March 2020 113,618 17,633 17,084 148,335
Additions - 605 - 605
At 30 September 2020 113,618 18,238 17,084 148,940
Disposals (113,618) (16,677) (17,084) (147,379)
At 31 March 2021 - 1,561 - 1,561
At 30 September 2021 - 1,561 - 1,561
Depreciation
At 31 March 2020 42,950 12,751 9,722 65,423
Charge 15,521 2,145 1,190 18,856
At 30 September 2020 58,471 14,896 10,912 84,279
Charge 11,846 917 439 13,202
Eliminated on disposal (70,317) (15,209) (11,351) (96,877)
At 31 March 2021 - 604 - 604
Charge - 259 - 259
At 30 September 2021 - 863 - 863
Carrying amount
At 30 September 2020 55,147 3,342 6,172 64,661
At 31 March 2021 - 957 - 957
At 30 September 2021 - 698 - 698
6. Intangible Assets
Goodwill Patents Total
£ £ £
Cost
At 31 March 2020 4,023,484 449,611 4,473,095
At 30 September 2020 4,023,484 449,611 4,473,095
At 31 March 2021 4,023,484 449,611 4,473,095
At 30 September 2021 4,023,484 449,611 4,473,095
Amortisation
At 31 March 2020 - 225,233 225,233
Amortisation charge - 22,481 22,481
At 30 September 2020 - 247,714 247,714
Amortisation charge - 38,513 38,513
At 31 March 2021 - 286,227 286,227
Amortisation charge - 18,228 18,228
At 30 September 2021 - 304,455 304,455
Net book value
At 30 September 2020 4,023,484 201,897 4,225,381
At 31 March 2021 4,023,484 163,384 4,186,868
At 30 September 2021 4,023,484 145,156 4,168,640
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
2021 2020 2021
Unaudited Unaudited Audited
No. £ No. £ No. £
Ordinary shares of £0.001 each 591,609,368 591,609 490,145,083 490,145 591,609,368 591,609
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.
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 interim management report includes a fair review of the
information required by:
2.1. 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
2.2. 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 2021 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/)
Dr Alastair Riddell
Executive Chairman
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
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