TIDMC4XD
RNS Number : 9911W
C4X Discovery Holdings PLC
29 April 2021
This announcement contains inside information
C4X Discovery Holdings plc
("C4XD", "C4X Discovery" or the "Company")
Half-year results for the six months ended 31 January 2021
Up to EUR414 million out-licensing to Sanofi of IL-17A oral
inhibitor programme
Drug discovery programmes advance across high value
portfolio
29 April 2021 - C4X Discovery Holdings plc (AIM: C4XD), a
pioneering Drug Discovery company, today announces its interim
results for the six months ended 31 January 2021.
Dr Clive Dix, CEO of C4X Discovery, commented: "C4X Discovery
has continued to advance its high value portfolio of commercially
attractive drug candidates for future partners and, post-period
end, a EUR414 million agreement was signed with Sanofi for our
IL-17A oral inhibitor programme, demonstrating the value of C4XD's
Drug Discovery expertise and our business model. C4XD's focus will
now be to further augment the portfolio, continue to build its
network of partnerships and advance the pipeline of proprietary and
partnered projects. With two programmes now successfully partnered
and a roadmap of potential cash milestones over the next 12-24
months, the Board is confident that, through the delivery of next
generation, high quality out-licensing opportunities, C4XD can
deliver significant value for shareholders ."
Operational highlights (including post-period events):
-- Indivior's Phase 1 with C4X_3256 progressing. Single
ascending dose study in healthy volunteers successfully completed
in April 2021 and preparation for multiple ascending dose study
underway
-- One of C4XD's NRF-2 lead activators C4X-6746 shown to
significantly inhibit disease score in a pre-clinical model of
inflammatory bowel disease ("IBD"). Candidate nomination and
preliminary safety studies continue
-- <ALPHA>4<BETA>7 integrin inhibitor programme for
the treatment of IBD demonstrated significant selectivity vs
<ALPHA>4<BETA>1 in vitro and oral bioavailability in PK
studies. Discussions with potential partners under CDA continue
-- C4XD and LifeArc risk-share collaboration to progress a small
molecule MALT-1 inhibitor programme has made progress, with three
novel series identified
-- Post-period
-- Exclusive worldwide licensing agreement with Sanofi for
C4XD's IL-17A oral inhibitor programme worth up to EUR414 million
including:
-- EUR7 million upfront
-- EUR407 million in potential development, regulatory and
commercialisation milestones, of which EUR11 million is in
pre-clinical milestones
-- Potential for single-digit royalties
-- Following scientific progress over the last year, C4XD is now
taking on the leadership of the MALT-1 programme from LifeArc to
drive it towards the later stages of drug discovery and deliver a
commercial deal
-- Appointment of Simon Harford as a Non-Executive Director to
the Board
Financial highlights:
-- Successful fundraise of GBP15.0 million (before expenses)
with a total of 107,142,858 shares issued to both new and existing
shareholders
-- R&D investment was GBP3.3 million in the six months
ending 31 January 2021, down GBP0.3million from the GBP3.6 million
in the six months ended 31 January 2020
-- Cash, cash equivalents, short-term investments and deposits
at 31 January 2021 of GBP15.4 million (31 July 2020: GBP5.6 million
and 31 January 2020: GBP5.5 million)
-- Cash events post-period:
- Imminent EUR7 million upfront payment following the deal with
Sanofi
- Received GBP1.8m R&D tax credit due in respect of the
financial year ended 31 July 2020
-- Strong cash position and manageable fixed cost base means the
Company has sufficient funding for the foreseeable future
-- Net assets at 31 January 2021 of GBP19.0 million (31 July
2020: GBP8.1 million and 31 January 2020: GBP10.3 million)
Analyst conference call today
Dr Clive Dix, Chief Executive Officer, and members of the
management team will host a webcast for analysts at 10.30am UK time
today. A copy of the final results presentation will be released
later this morning on the Company website at www.c4xdiscovery.com .
Please contact Consilium Strategic Communications for details on
C4XDiscovery@consilium-comms.com / +44 203709 5700.
For further information, please contact:
C4X Discovery Holdings plc
Mo Noonan, Communications +44 (0) 787 6444977
Panmure Gordon (UK) Limited (NOMAD and Broker) +44 (0) 20 7886 2500
Freddy Crossley, Emma Earl (Corporate Finance)
Rupert Dearden (Corporate Broking)
Consilium Strategic Communications
Mary-Jane Elliott, Chris Gardner, Matthew
Neal +44 (0) 20 3709 5700
Notes to Editors:
About C4X Discovery
C4X Discovery ("C4XD") is a pioneering Drug Discovery company
combining scientific expertise with cutting-edge Drug Discovery
technologies to efficiently deliver world--leading medicines, which
are developed by our partners for the benefit of patients. We have
a highly valuable and differentiated approach to Drug Discovery
through our enhanced DNA-based target identification and candidate
molecule design capabilities, generating small molecule drug
candidates across multiple disease areas including inflammation,
neurodegeneration, oncology and addictive disorders. Our
commercially attractive portfolio ranges from early stage novel
target opportunities to late stage Drug Discovery programmes ready
for a commercial deal and to date we have successfully out-licensed
two programmes with one candidate in clinical development.
We collaborate with leading pharmaceutical and life sciences
companies to enrich our expertise and take our assets through
pre-clinical and clinical development. Through early-stage
revenue-generating licensing deals, we realise returns from our
high value pre-clinical assets which are reinvested to maximise the
value of our Drug Discovery portfolio. For more information visit
us at www.c4xdiscovery.com or follow us on twitter @C4XDiscovery
.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014 (MAR).
Corporate Overview
C4XD saw progress across its drug discovery portfolio, with a
number of programmes making significant advances, particularly in
inflammation with the announcement post period of a EUR414 million
exclusive, worldwide out-licensing agreement with Sanofi for our
IL-17A inhibitor programme. Together with advancements in early
innovation projects and partnered collaborations, C4XD continues to
focus on building a sustainable pipeline of potential future
out-licensing opportunities.
The Company has a strong cash position and manageable fixed cost
base that means the Company has sufficient funding for the
foreseeable future. In October 2020, C4XD announced a GBP15 million
placing, providing the Company with a robust financial base from
which to advance its portfolio. Cash, cash equivalents, short-term
investments and deposits were at 31 January 2021 of GBP15.4 million
(31 July 2020: GBP5.6 million and 31 January 2020: GBP5.5 million).
Cash events post-period included the imminent EUR7 million upfront
payment following the deal with Sanofi and the Company has also
received GBP1.8m R&D tax credit due in respect of the financial
year ended 31 July 2020. Going forward any proceeds arising from
the exercise of the Warrants in the placing as announced 21 October
2020 will further strengthen the cash position of the Company.
R&D investment remained stable and was GBP3.3 million in the
six months ending 31 January 2021, down GBP0.3million from the
GBP3.6 million in the six months ended 31 January 2020. Likewise
Administrative Expenses were also down GBP0.1 million, to
GBP1.2million from GBP1.3 million in the prior year.
Post period, in April 2021, we welcomed Simon Harford to the
Board of C4XD as a Non-Executive Director. He joins with more than
30 years of expertise across key financial markets and will be a
valuable asset as we grow C4XD and expedite deals such as the one
recently announced with Sanofi.
Drug Discovery Pipeline
Oral Orexin-1 Antagonist (C4X_3256/INDV-2000) - Partnered with
Indivior
The US$294 million licensing deal with Indivior for C4XD's oral
Orexin-1 receptor antagonist C4X_3256, also known as INDV-2000, for
the treatment of addiction continues to progress. INDV-2000 has
recently completed a Phase I first in human single ascending dose
clinical trial for the treatment of opioid dependence
(https://www.clinicaltrials.gov/ct2/show/NCT04413552). Preparation
for the initiation of a multiple ascending dose study to be
conducted by Indivior is underway.
Oral IL-17A Inhibitor Programme - Partnered with Sanofi
C4XD has identified small molecules in its oral IL-17 inhibitor
programme that can selectively block IL-17 activity whilst
maintaining molecular size of the molecule in the traditional
"drug-like" range. A novel, potent oral series of IL-17 inhibitors
that significantly reduce IL-17 induced inflammation in vivo is
being optimised towards candidate shortlist. In April 2021, C4XD
announced an out-licensing agreement with Sanofi for its IL-17A
inhibitor programme for up to EUR414 million. The Company will
receive an upfront payment of EUR7 million and could receive up to
a further EUR407 million in potential development, regulatory and
commercialisation milestones, of which EUR11 million is in
pre-clinical milestones, in addition to single digit royalties.
Sanofi will take control of the programme but will continue to work
with C4XD in the next discovery phase to utilise our Conformetrix
technology and expertise as the programme progresses towards the
clinic.
Oral NRF-2 Activator Programme
The Company has identified a series of keap-1 inhibitors in its
oral NRF-1 activator programme, which have been found to
significantly activate NRF-2 following oral dosing, providing
anti-inflammatory and anti-oxidant activity. In C4XD studies,
multiple lead compounds show greater than 12-hour duration of
action following low oral dosing on activation of NRF-2 in key
tissues such as the lung, the liver and in blood. More recently,
one of C4XD's lead NRF-2 activator molecules has also been shown to
significantly inhibit the disease score in a pre-clinical model of
IBD in a dose-dependent manner. Candidate nomination studies and
preliminary safety studies are underway ahead of progressing to IND
enabling studies, which are considered to be required in order to
increase value and further differentiate from competitor
molecules.
Oral <ALPHA>4<BETA>7 integrin inhibitor
Programme
C4XD' s oral <ALPHA>4<BETA> 7 integrin inhibitor
programme has identified novel, potent and selective
<ALPHA>4<BETA> 7 integrin inhibitors for the treatment
of Inflammatory Bowel Disease ( "IBD" ). In August 2020, the
Company announced that significant progress has been made on C4XD's
early oral inhibitor programme targeting
<ALPHA>4<BETA>7 integrin for the treatment of IBD.
Effective antibody therapy against this target is already approved,
removing the clinical target risk, but effective oral therapy
remains highly sought after. C4XD has identified a second series of
novel, potent and selective inhibitors providing a further
competitive edge for this programme. This reaffirms the capability
of C4XD's Conformetrix technology to discover novel chemical
scaffolds for high value challenging drug targets.
Both series have recently demonstrated oral bioavailability in
PK studies with the current focus on improving PK properties to
demonstrate functional inhibition of <ALPHA>4<BETA>7
integrin in vivo following oral dosing. The Company is currently
generating improved molecules to move to in vivo studies and,
despite being early stage, the Company is in confidential
discussions with several potential partners.
Oral MALT-1 Inhibitor Programme
In November 2018, C4XD entered into a risk-share discovery
collaboration with LifeArc(R) , a UK medical research charity, to
progress medicinal chemistry efforts on a MALT-1 inhibitor
programme with applicability across oncology and inflammation
indications, with a primary focus of haematological cancers. Three
novel series have been identified by harnessing C4XD's Conformetrix
technology and data obtained in 2020 has demonstrated functional
cell activity and oral bioavailability. Optimisation studies
continue to increase cellular potency with the aim of showing in
vivo inhibition of the target for a prototype molecule. C4XD is now
taking on leadership of the MALT-1 programme from LifeArc to drive
it towards the later stages of drug discovery and deliver a
commercial deal.
Outlook
C4X Discovery has continued to advance its high value portfolio
of commercially attractive drug candidates for future partners and,
post-period end, a EUR414 million agreement was signed with Sanofi
for our IL-17A oral inhibitor programme, demonstrating the value of
C4XD's Drug Discovery expertise and our business model. C4XD's
focus will now be to further augment the portfolio, continue to
build its network of partnerships and advance the pipeline of
proprietary and partnered projects. With two programmes now
successfully partnered and a roadmap of potential cash milestones
over the next 12-24 months, the Board is confident that, through
the delivery of next generation, high quality out-licensing
opportunities, C4XD can deliver significant value for shareholders
.
Interim consolidated statement of comprehensive income
For the six months ended 31 January 2021
Six months Six months Year
to to to
31 January 31 January 31 July
2021 2020 2020
(Unaudited) (Unaudited) (Audited)
GBP000 GBP000 GBP000
Notes
Revenue - - -
Cost of sales - - -
Gross profit - - -
Research and development
expenses (3,304) (3,567) (6,858)
Administrative expenses (1,217) (1,322) (2,708)
Operating loss (4,521) (4,889) (9,566)
Finance income - - 5
Finance costs (7) (10) (18)
------------ ------------ ----------
Loss before taxation (4,528) (4,899) (9,579)
Taxation 3 888 910 1,790
Loss for the period
and total comprehensive
loss for the period (3,640) (3,989) (7,789)
============ ============ ==========
Loss per share :
Basic and diluted loss
for the period 4 (2.19)p (5.02)p (8.10)p
============ ============ ==========
Interim consolidated statement of changes in equity
For the six months ended 31 January 2021
Share
Issued based Capital
equity Share payment Merger contribution Revenue
capital premium reserve reserve reserve reserve Total
GBP000 GBP000 GBP000 GBP000 GBP000 GBP000 GBP000
At 01 August 2019 2,602 32,256 736 920 195 (29,724) 7,013
Impact of change in accounting
policy - - - - - (28) (28)
-------- -------- --------- -------- -------------- --------- --------
At 01 August 2019 adjusted 2,602 32,256 736 920 195 (29,724) 6,985
-------- -------- --------- -------- -------------- --------- --------
Loss for the six months
to 31 January 2020 - - - - - (3,989) (3,989)
Issue of share capital 507 7,079 - - - - 7,586
Expenses of placing,
open offer and subscription
by directors - (443) - - - - (443)
Share-based payments - - 107 - - - 107
At 31 January 2020 3,109 38,892 843 920 195 (33,713) 10,246
======== ======== ========= ======== ============== ========= ========
Loss for the six months
to 31 July 2020 - - - - - (3,800) (3,800)
Issue of share capital 107 1,519 - - - - 1,626
Expenses of placing and
open offer - (104) - - - - (104)
Share-based payments - - 99 - - - 99
At 31 July 2020 3,216 40,306 942 920 195 (37,513) 8,066
======== ======== ========= ======== ============== ========= ========
Loss for the six months
to 31 January 2021 - - - - - (3,640) (3,640)
Issue of share capital 1,072 13,928 - - - - 15,000
Expenses of placing,
open offer and subscription
by directors - (551) - - - - (551)
Share-based payments - - 117 - - - 117
At 31 January 2021 4,288 53,683 1,059 920 195 (41,153) 18,992
======== ======== ========= ======== ============== ========= ========
Interim consolidated statement of financial position
As at 31 January 2021
31 January 31 January 31 July
2021 2020 2020
(Unaudited) (Unaudited) (Audited)
GBP000 GBP000 GBP000
Notes
Assets
Non-current assets
Property, plant and
equipment 41 58 47
Intangible assets 88 228 157
Goodwill 1,192 1,192 1,192
Right-of-use assets 492 562 377
------------ ------------ ----------
1,813 2,040 1,773
------------ ------------ ----------
Current assets
Trade and other receivables 616 580 438
Income tax asset 2,668 3,610 1,780
Cash and cash equivalents 15,396 5,503 5,648
------------ ------------ ----------
18,680 9,693 7,866
------------ ------------ ----------
Total assets 20,493 11,733 9,639
------------ ------------ ----------
Liabilities
Current liabilities
Trade and other payables (985) (897) (1,166)
Lease liabilities (219) (316) (189)
------------ ------------ ----------
(1,204) (1,213) (1,355)
------------ ------------ ----------
Non-current liabilities
Lease liabilities (297) (246) (218)
(297) (246) (218)
------------ ------------ ----------
Total liabilities (1,501) (1,459) (1,573)
------------ ------------ ----------
Net assets 18,992 10,274 8,066
============ ============ ==========
Capital and reserves
Issued equity capital 5 4,288 3,109 3,216
Share premium 5 53,683 38,892 40,306
Share-based payment
reserve 1,059 843 942
Merger reserve 920 920 920
Capital contribution
reserve 195 195 195
Revenue reserve (41,153) (33,685) (37,513)
Total equity 18,992 10,274 8,066
============ ============ ==========
Approved by the Board and authorised for issue on 29 April
2021
Brad Hoy
Chief Financial Officer
28 April 2021
Interim consolidated cash flow statement
For the six months ended 31 January 2021
Six months Six months Year
to to to
31 January 31 January 31 July
2021 2020 2020
(Unaudited) (Unaudited) (Audited)
GBP000 GBP000 GBP000
Loss after tax and interest (3,640) (3,989) (7,789)
Adjustments for:
Depreciation of property, plant and
equipment 16 25 45
Depreciation of right-of-use assets 139 131 302
Amortisation of intangible assets 69 67 138
Share-based payments 117 107 206
Finance income - - (5)
Finance costs 7 10 18
Taxation (888) (910) (1,790)
Changes in working capital:
Decrease/(increase) in trade and other
receivables (178) 61 203
(Decrease)/increase in trade and other
payables (181) (755) (486)
Cash outflow from operating activities (4,539) (5,253) (9,158)
Research and development tax credit
received - 1,376 4,086
Net cash outflow from operating activities (4,539) (3,877) (5,072)
------------ ------------ ----------
Cash flows from investing activities:
Purchases of property, plant and equipment (11) (5) (14)
Finance income - - 5
------------ ------------ ----------
Net cash outflow from investing activities (1) (1) (9)
------------ ------------ ----------
Cash flows from financing activities:
Payment of lease liabilities (151) (141) (319)
Proceeds from the issue of ordinary
share capital 15,000 7,586 9,212
Expenses of placing, open offer and
subscription by directors (551) (443) (547)
Net cash inflow from financing activities 14,298 6,998 8,346
------------ ------------ ----------
Increase/(decrease) in cash and cash
equivalents 9,748 3,120 3,265
Cash and cash equivalents at the start
of the period 5,648 2,383 2,383
------------ ------------ ----------
Cash, cash equivalents and deposits
at the end of the period 15,396 5,503 5,648
============ ============ ==========
Notes to the interim financial report
For the six months ended 31 January 2021
1. Corporate information
The principal activity of the C4X Discovery Holdings plc is
research and development, a review of which is included in the
Chairman's and CEO's Statement.
C4XD is incorporated and domiciled in the United Kingdom and its
registered number is 09134041. The address of the registered office
is Manchester One, 53 Portland Street, Manchester, M1 3LD.
The interim financial information was approved for issue on 29
April 2021.
2. Accounting policies
Basis of preparation
The accounting policies adopted in this interim financial report
are consistent with those followed in the preparation of the
Group's annual report and accounts for the year to 31 July 2020,
except for the following changes:
The interim financial information for the six months ended 31
January 2021 and 31 January 2020 is unaudited and does not
constitute statutory accounts as defined in the Companies Act 2006.
This interim financial report includes audited comparatives for the
year to 31 July 2020. The 2020 annual report and accounts received
an unqualified audit opinion and has been filed with the Registrar
of Companies.
These interim financial statements have been prepared in
accordance with IAS34 Interim Financial Reporting. They do not
include all the information required for a complete set of IFRS
financial statements. However, selected explanatory notes are
included to explain events and transactions that are significant to
an understanding of the changes in the Group's financial position
and performance since the last annual consolidated financial
statements as at and for the year ended 31 July 2020.
Basis of consolidation
This interim financial report consolidates the financial
statements of C4X Discovery Holdings plc and the entities it
controls (its subsidiaries).
3. Taxation
Six months Six months Year to
to to
31 January 31 January 31 July
2021 2020 2020
GBP000 GBP000 GBP000
UK corporation tax losses in the - - -
period
Research and development income
tax credit receivable (888) (900) (1,780)
Adjustment in respect of prior
periods - (10) (10)
(888) (910) (1,790)
----------- ----------- --------
4. Loss per share
31 January 31 January 31 July
2021 2020 2020
GBP000 GBP000 GBP000
Loss for the financial period
attributable to equity shareholders (3,640) (3,989) (7,789)
-------------------------------------- ------------ ----------- -----------
Weighted average number of shares: No. No. No.
Ordinary shares in issue 166,412,628 79,385,238 96,123,309
-------------------------------------- ------------ ----------- -----------
Basic loss per share (pence) (2.19)p (5.02)p (8.10)p
-------------------------------------- ------------ ----------- -----------
Diluted loss per share has not been presented above as the
effect of share options issued is anti-dilutive.
5. Issued share capital and share premium
Deferred Ordinary Share Deferred Share
shares shares capital shares premium Total
Number Number GBP000 GBP000 GBP000 GBP000
-------------------------- ---------- ------------ --------- --------- --------- -------
Ordinary and deferred
shares as at 31 January
2020 2,025,000 108,366,444 1,084 2,025 38,892 42,001
-------------------------- ---------- ------------ --------- --------- --------- -------
Issue of share capital
on placing - 10,836,700 108 - 1,518 1,626
-------------------------- ---------- ------------ --------- --------- --------- -------
Expenses of placing - - - - (104) (105)
-------------------------- ---------- ------------ --------- --------- --------- -------
Ordinary and deferred
shares as at 31 July
2020 2,025,000 119,203,144 1,191 2,025 40,306 43,522
-------------------------- ---------- ------------ --------- --------- --------- -------
Issue of share capital
on placing - 99,169,286 992 - 12,892 13,884
Issue of share capital
on open offer - 7,973,572 80 1,036 1,116
Expenses of placing
and open offer - - - - (551) (551)
-------------------------- ---------- ------------ --------- --------- --------- -------
Ordinary and deferred
shares as at 31 January
2021 2,025,000 226,346,002 2,263 2,025 53,683 57,971
-------------------------- ---------- ------------ --------- --------- --------- -------
6. Interim financial report
A copy of this interim condensed financial report is available
on C4XD's website at www.c4xdiscovery.com .
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