REG - C4X Discovery - Half Year Results
28/04/2022 07:00
For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20220428:nRSb5963Ja&default-theme=true
RNS Number : 5963J C4X Discovery Holdings PLC 28 April 2022
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 2022
Third proprietary programme advancing towards partnership
Expansion of portfolio with the addition of six new early-stage programmes
28 April 2022 - C4X Discovery Holdings plc (AIM: C4XD), a pioneering Drug
Discovery company, today announces its half-year results for the six months
ended 31 January 2022.
Dr Clive Dix, CEO of C4X Discovery, said: "Following the successful
out-licensing agreement for our IL-17A inhibitor programme last year, we have
continued to make substantial progress across our portfolio with our NRF2
programme now in advanced commercial discussions with multiple partners. A
strong focal point for the Company over the past six months has been to expand
our portfolio. The team has analysed over 80 opportunities and selective
feasibility studies have led to six new projects entering our portfolio. We
are applying our rigorous assessment to ensure that each programme is
scientifically viable, commercially attractive and has the potential to offer
meaningful future returns to our investors. With our next key programme
advancing towards partnership, a strong and resilient approach to replenishing
the pipeline and having strengthened our leadership during the period, we
believe that C4XD is well positioned for ambitious future growth."
Operational Highlights (including post-period events)
· Indivior progressing the Phase 1 clinical trial of C4XD's oral
Orexin-1 receptor antagonist, C4X_3256, for addiction with preparations for
multiple ascending dose study ongoing
· C4XD's second out-licensed programme, IL-17A inhibitor for
inflammatory diseases, is making strong progress towards the next milestone
with our partner Sanofi
· Advanced commercial discussions with multiple potential partners for
NRF2 activator programme for inflammatory diseases with pre-candidate
nomination, preliminary safety and efficacy studies completed.
· α4β7 integrin inhibitor programme for inflammatory diseases
generated multiple chemical series showing activity and selectivity vs α4β1
matching or exceeding current clinical compounds
· MALT-1 inhibitor programme for cancer transitioned into lead
optimisation phase after demonstrating in vivo activity with multiple series
· C4XD programme portfolio expanded with the addition of six
early-stage pipeline programmes. These are being resourced to achieve
significant chemistry and biology progression milestones
· Board appointments of Dr Mario Polywka as Non-Executive Director
and Bhavna Hunjan as Chief Business Officer as Dr Harry Finch stepped down
from the Board. Dr Catherine Tralau-Stewart succeeds Craig Fox as Chief
Scientific Officer
Financial Highlights
· Revenue was £66,000 (January 2021: £nil)
· Total loss after tax of £4.5 million or 1.98 pence per share
(January 2021: £3.6m or 2.19 pence per share)
· R&D expenses were £3.9 million (January 2021: £3.3m),
reflecting focused investment in key Drug Discovery programmes
· Net assets of £15.2 million (January 2021: £19.0m)
· Net cash as at 31 January 2022: £11.7 million (31 January 2021:
£15.4m)
Analyst webcast and conference call today
Dr Clive Dix, Chief Executive Officer, and members of the management team will
host a webcast for analysts at 10am BST today. The webcast can be accessed
online at:
https://www.lsegissuerservices.com/spark/C4xDiscoveryHolding/events/be580a3b-99d2-433d-a6cc-82595bd2013d
(https://www.lsegissuerservices.com/spark/C4xDiscoveryHolding/events/be580a3b-99d2-433d-a6cc-82595bd2013d)
A copy of the final results presentation will be released later this morning
on the Company website at www.c4xdiscovery.com (http://www.c4xdiscovery.com) .
- Ends -
Contacts
C4X Discovery Holdings
Mo Noonan, Communications +44 (0)787 6444977
Panmure Gordon (UK) Limited (NOMAD and Broker)
Freddy Crossley, Emma Earl (Corporate Finance) +44 (0)20 7886 2500
Rupert Dearden (Corporate Broking)
C4X Discovery Media - Consilium Strategic Communications
Mary-Jane Elliott, Chris Gardner, Matthew Neal +44 (0)203 709 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 out-licensing
to partners and we have two commercially partnered 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 (http://www.c4xdiscovery.com) or follow us on
twitter @C4XDiscovery.
Corporate Overview
The first six months of the year has been a period of positive progress across
the entire portfolio. Following the successful €414 million exclusive,
worldwide out-licensing of our IL-17A inhibitor programme to Sanofi in April
last year, we have made strong headway working alongside Sanofi towards the
next milestone in the agreement. Our partner, Indivior, has continued to
advance the Orexin-1 antagonist programme for addictive disorders with
preparation ongoing for the multi-ascending dose study. We have continued to
drive key programmes towards partnering with significant advances in our NRF2
programme for inflammatory diseases, α4β7 integrin inhibitor programme for
inflammatory bowel disease ("IBD") and our MALT-1 inhibitor programme for
oncology and inflammation indications.
A key element of focus this year is to replenish and scale our pipeline of
programmes to ensure a strong and sustainable future for C4XD. The team has
analysed over 80 opportunities and following selective feasibility studies, we
now have six new early-stage programmes in the pipeline. These are
undergoing our rigorous evaluation process to ensure that the programmes we
have selected offer all the right attributes to deliver a successful molecule
for out-licensing. Each programme will go through a series of chemistry and
biological tests to begin building the dataset for that programme and to
stress test their viability. We believe in a kill fast policy and any
programmes that do not withstand our rigorous process will be discontinued to
redirect investment towards other programmes demonstrating greater
potential. That way we can ensure the continued consistency and quality of
molecules we have in our pipeline to date. In addition, to further build out
our portfolio, we are open to innovative and high-quality opportunities from
within academic research or through technology and industry collaborations.
We have a strong track record as a good partner, with the drive and focus to
deliver new molecules for out-licensing to the pharmaceutical industry.
The Company has a robust cash position and manageable fixed cost base. Cash,
cash equivalents, short-term investments and deposits were £11.7 million at
31 January 2022 (31 January 2021: £15.4 million). R&D investment
remained stable at £3.9 million in the six months ending 31 January 2022
(January 2021: £3.3 million). Administrative Expenses were £1.6 million
compared to £1.2 million in the prior year.
During the period we announced a number of senior appointments. In December,
we were delighted to welcome Catherine Tralau-Stewart to succeed Craig Fox as
C4XD's new Chief Scientific Officer. Cathy is a highly respected scientific
leader with strong and deep drug discovery expertise. Her broad and in-depth
knowledge of drug discovery and translation of early research innovation into
robust drug discovery programmes will further advance C4XD's scientific
portfolio and support effective decision-making. We also appointed Dr Mario
Polywka as a Non-Executive Director to replace Dr Harry Finch who stood down
from the Board. Mario joins C4XD with more than 20 years' experience across
the biotech industry and brings strong operational, commercial, strategic and
drug discovery expertise to the Board. In January, we strengthened the Board
with Bhavna Hunjan's appointment as Chief Business Officer and Emma Blaney
joined the Executive Team as Chief Operating Officer. These internal
promotions reflect the positive impact Bhavna and Emma have had on the
business overall and they have been fundamental to the success of the Company.
Portfolio Review
Addictive disorders (Orexin-1 Antagonist) - out-licensed to Indivior
Indivior progressing preparation for Phase 1 multiple ascending dose study
Under C4XD's milestone and royalties agreement with Indivior worth up to
US$284 million for C4XD's oral Orexin-1 receptor antagonist C4X_3256
(INDV-2000) for the treatment of addiction, Indivior has continued to make
preparatory progress on formulation and chemical development for the Phase I
multiple ascending dose study. INDV-2000 has successfully completed the
Phase I first in human single ascending dose clinical trial showing
encouraging safety and pharmacokinetics in healthy volunteers. The
additional U.S. FDA-requested 28-day repeat-dose toxicology study is
anticipated to read-out in Q2 2022.
Opioid addiction is an increasing burden on the healthcare system,
particularly in the US but is a growing global issue. For the first time
ever, the U.S. exceeded 100,000 overdose deaths, up by 21%, with synthetic
opioids including fentanyl accounting for 65% of fatal overdoses(1).
Inflammation (IL-17A Inhibitor) - out-licensed to Sanofi
Sanofi-led programme making significant progress
Last year, C4XD completed an out-licensing agreement with Sanofi for its
IL-17A inhibitor programme for up to €414 million with milestones and
royalties. The programme is now under Sanofi's leadership and is making
strong progress. The C4XD team have been working with Sanofi to utilise our
Conformetrix technology and expertise as the programme rapidly advances
towards the next milestone in the agreement.
Interleukin-17 (IL-17A) is a key cytokine that links T cell activation to
neutrophil mobilisation and activation. As such, IL-17 can mediate protective
innate immunity to pathogens or contribute to inflammatory disease
progression, such as psoriasis(2). U.S. FDA-approved injectable biologics
targeting IL-17, secukinumab and ixekizumab, generated combined net sales of
~$7bn in 2021 and have demonstrated that the mechanism is both safe and
efficacious.
C4XD's oral IL-17A inhibitor programme can selectively block IL-17 activity
whilst maintaining molecular size of the molecule in the traditional
"drug-like" range. This gives the potential to deliver the therapeutic
benefit of existing antibody therapeutics in a more convenient form and
thereby address the unmet need for a safe and effective oral therapy that can
expand the treated patient population across multiple inflammatory diseases.
Inflammation (NRF2 Activator)
Advanced commercial discussions with multiple potential partners
Inflammation is a key driver in many pathological conditions. NRF2 plays a
pivotal role in controlling the expression of antioxidant genes that
ultimately exert anti-inflammatory functions. Targeting the NRF2 pathway to
reduce inflammatory damage offers the potential for a new approach to treat a
variety of inflammatory diseases. Interest in this therapeutic approach
covers multiple therapeutic areas including chronic obstructive pulmonary
disease, atopic dermatitis, IBD, pulmonary arterial hypertension and sickle
cell disease.
Oral dosing in C4XD's NRF2 activator programme has shown to significantly
activate NRF2, providing anti-inflammatory and antioxidant activity. In C4XD
studies, multiple lead compounds show greater than 12-hour duration of action
following low oral dosing on activation of NRF2 in key tissues such as the
lung, the liver and in blood. Pre-candidate nomination and preliminary
safety studies including significant drug substance scale-up to support
longer-term studies have now been successfully completed.
Advanced partnering discussions are ongoing for this programme with multiple
parties and include partner-funded studies under Material Transfer Agreements
(MTA) to validate C4XD molecules in a partner's in-house biological assays and
disease models. This is in line with C4XD's strategy to out-licence our drug
discovery programmes at a pre-clinical stage to generate returns for our
investors.
Inflammation (α4β7 Integrin Inhibitor)
Multiple chemical series showing activity and selectivity vs α4β1 matching
or exceeding current clinical compounds
C4XD's oral α4β7 integrin inhibitor programme has identified multiple series
of novel, potent and selective α4β7 integrin inhibitors for the treatment of
IBD. Effective antibody therapy against this target is already approved,
removing the clinical target risk, but an effective oral therapy remains
highly sought after. During 2021, Morphic Therapeutic's Phase 1 clinical
study demonstrated high target occupancy in blood at developable doses but
with a twice daily profile. C4XD's programme is targeting a much desired
once-a-day profile.
Oral bioavailability, in C4XD's α4β7 integrin inhibitor programme for the
treatment of IBD, has been demonstrated and there is particular focus on
improving PK properties to achieve a good oral half-life. External interest
in this programme remains significant with the potential for out-licensing,
should further studies demonstrate the potential for a once-daily profile.
Haematological Cancer (MALT1 Inhibitor)
Lead optimisation phase
MALT1 is one of the key regulators of B-cell receptor (BCR) and T-cell
receptor (TCR) signalling. Mutations that lead to constitutive activation of
MALT1 are associated with aggressive forms of non-Hodgkin B-cell lymphoma and
inhibition of MALT1 has potential therapeutic applicability as a mono therapy
for MALT1-driven cancers such as activated B-cell diffuse large B-cell
lymphoma (ABC-DLBCL) and in combination with BTK inhibitors across multiple
haematological indications, as well as broader potential in solid tumours and
inflammation.
During the period, C4XD licensed the MALT1 Inhibitor programme from
LifeArc(®), a UK medical research charity, and is now leading the programme.
To date, three novel series have been identified by harnessing C4XD's
Conformetrix technology which demonstrate functional cell activity and oral
bioavailability. The programme has transitioned to lead optimisation having
demonstrated in vivo activity equivalent to that achieved with J&J's
clinical candidate JNJ-67856633 across multiple series.
Expansion of Pipeline
As we look to scale our portfolio, six new early-phase programmes are being
resourced to target significant chemistry and biology progression
milestones. These programmes target clear unmet medical need, combined with
significant commercial potential and a unique opportunity to produce valuable
chemical equity and IP through interpretation of conformational insight via
C4XD's Conformetrix and 4Sight technologies. Details of each programme will
be provided once robust data has been generated exemplifying novel chemical
matter.
Outlook
In the coming months, we will continue to work with our partners to progress
out-licensed programmes towards the next milestone, drive forward each
programme in our portfolio towards partnership and advance commercial
discussions for our third programme, NRF2. With a strong and resilient
approach to replenishing the pipeline and having strengthened our leadership
during the period, we believe that C4XD is well positioned for ambitious
future growth.
1.
https://www.indivior.com/resources/dam/id/838/Indivior%20FY%202021%20Presentation%20for%20Webcast.pdf
2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4530463/
3. Plaque Psoriasis: Global Drug Forecast and Market Analysis to 2027,
GlobalData, December 2018
Interim consolidated statement of comprehensive income
For the six months ended 31 January 2022
Six months Six months Year
to to to
31 January 2022 31 January 2021 31 July
2021
(Unaudited) (Unaudited) (Audited)
£000 £000 £000
Notes
Revenue 66 - 5,642
Cost of sales (59) - (90)
Gross profit 7 - 5,552
Research and development expenses (3,942) (3,304) (8,263)
Administrative expenses (1,595) (1,217) (3,182)
Operating loss (5,530) (4,521) (5,893)
Finance income - - 1
Finance costs (7) (7) (15)
Loss before taxation (5,537) (4,528) (5,907)
Taxation 3 1,020 888 2,063
Loss for the period and total comprehensive loss for the period (4,517) (3,640) (3,844)
Loss per share:
Basic loss for the period 4 (1.98)p (2.19)p (1.96)p
Diluted loss for the period 4 (1.81)p (2.18)p (1.82)p
Interim consolidated statement of changes in equity
For the six months ended 31 January 2022
Issued equity Share Warrant Share based payment Merger Capital contribution Revenue
capital premium reserve reserve reserve reserve reserve Total
£000 £000 £000 £000 £000 £000 £000 £000
At 01 August 2020 3,216 40,306 - 942 920 195 (37,513) 8,066
Loss for the six months to - - - - - - (3,640) (3,640)
31 January 2021
Issue of share capital 1,072 12,936 - - - - - 14,008
Expenses of placing, open offer and subscription by directors - (551) - - - - - (551)
Issue of warrants - - 992 - - - - 992
Share-based payments - - - 117 - - - 117
At 31 January 2021 4,288 52,691 992 1,059 920 195 (41,153) 18,992
Loss for the six months to - - - - - - (204) (204)
31 July 2021
Issue of share capital - - - - - - - -
Expenses of placing and open offer - - - - - - - -
Exercise of options 2 6 - - - - - 8
Exercise of warrants 13 345 (13) - - - 13 358
Share-based payments - - - 132 - - - 132
At 31 July 2021 4,303 53,042 979 1,191 920 195 (41,344) 19,286
Loss for the six months to - - - - - - (4,517) (4,517)
31 January 2022
Issue of share capital - - - - - - - -
Expenses of placing, open offer and subscription by directors - - - - - - - -
Exercise of warrants 11 297 (11) - - - 11 308
Share-based payments - - - 114 - - - 114
At 31 January 2022 4,314 53,339 968 1,305 920 195 (45,850) 15,191
Interim consolidated statement of financial position
As at 31 January 2022
31 January 2022 31 January 2021 31 July 2021
(Unaudited) (Unaudited) (Audited)
£000 £000 £000
Notes
Assets
Non-current assets
Property, plant and equipment 30 41 33
Intangible assets 67 88 69
Goodwill 1,192 1,192 1,192
Right-of-use assets 266 492 377
1,555 1,813 1,671
Current assets
Trade and other receivables 571 616 574
Income tax asset 3,073 2,668 2,053
Cash and cash equivalents 11,679 15,396 17,103
15,323 18,680 19,730
Total assets 16,878 20,493 21,401
Liabilities
Current liabilities
Trade and other payables (1,390) (985) (1,647)
Lease liabilities (171) (219) (217)
(1,561) (1,204) (1,864)
Non-current liabilities
Trade and other payables - - (64)
Lease liabilities (126) (297) (187)
(126) (297) (251)
Total liabilities (1,687) (1,501) (2,115)
Net assets 15,191 18,992 19,286
Capital and reserves
Issued equity capital 5 4,314 4,288 4,303
Share premium 5 53,339 52,691 53,042
Share-based payment reserve 1,305 1,059 1,191
Warrant reserve 968 992 979
Merger reserve 920 920 920
Capital contribution reserve 195 195 195
Revenue reserve (45,850) (41,153) (41,344)
Total equity 15,191 18,992 19,286
Approved by the Board and authorised for issue on 27 April 2022
Brad Hoy
Chief Financial Officer
27 April 2022
Interim consolidated cash flow statement
For the six months ended 31 January 2022
Six months Six months Year
to to to
31 January 31 January 31 July
2022 2021 2021
(Unaudited) (Unaudited) (Audited)
£000 £000 £000
Loss after tax and interest (4,517) (3,640) (3,844)
Adjustments for:
Depreciation of property, plant and equipment 12 16 33
Depreciation of right-of-use assets 111 139 254
Amortisation of intangible assets 3 69 88
Share-based payments 114 117 249
Finance income - - (1)
Finance costs 7 7 15
Taxation (1,020) (888) (2,063)
Changes in working capital:
Decrease/(increase) in trade and other receivables 3 (178) (136)
(Decrease)/increase in trade and other payables (321) (181) 545
Cash outflow from operating activities (5,608) (4,539) (4,860)
Research and development tax credit received - - 1,790
Net cash outflow from operating activities (5,608) (4,539) (3,070)
Cash flows from investing activities:
Purchases of property, plant and equipment (10) (11) (20)
Finance income - - 1
Net cash outflow from investing activities (10) (11) (19)
Cash flows from financing activities:
Payment of lease liabilities (114) (151) (271)
Proceeds from the issue of ordinary share capital 308 15,000 15,366
Expenses of placing, open offer and subscription by directors - (551) (551)
Net cash inflow from financing activities 194 14,298 14,544
Increase/(decrease) in cash and cash equivalents (5,424) 9,748 11,455
Cash and cash equivalents at the start of the period 17,103 5,648 5,648
Cash, cash equivalents and deposits at the end of the period 11,679 15,396 17,103
Notes to the interim financial report
For the six months ended 31 January 2022
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 27 April 2022.
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 2021, except for the following changes:
The interim financial information for the six months ended 31 January 2022 and
31 January 2021 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 2021. The 2021 annual report
and accounts received an unqualified audit opinion and have 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 2021.
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 to Six months to Year to
31 January 31 January 31 July
2022 2021 2021
£000 £000 £000
UK corporation tax losses in the period - - -
Research and development income tax credit receivable (1,020) (888) (2,053)
Adjustment in respect of prior periods - - (10)
(1,020) (888) (2,063)
4. Loss per share
31 January 31 January 31 July
2022 2021 2021
£000 £000 £000
Loss for the financial period attributable to equity shareholders (4,517) (3,640) (3,844)
Weighted average number of shares: No. No. No.
Ordinary shares in issue 228,177,371 166,412,628 196,261,295
Number of exercisable share options and warrants 22,005,021 438,078 14,531,129
Ordinary shares in issue for purposes of diluted EPS 250,182,392 166,850,706 210,792,424
Basic loss per share (pence) (1.98)p (2.19)p (1.96)p
Diluted loss per share (pence) (1.81)p (2.18)p (1.82p
Both basic and diluted loss per share are reported due to the effect of
exercisable share options and warrants in issue.
5. Issued share capital and share premium
Deferred shares Ordinary shares Share capital Deferred shares Warrant reserve Share premium Total
Number Number £000 £000 £000 £000 £000
Ordinary and deferred shares as at 31 January 2021 2,025,000 226,346,002 1,084 2,025 992 52,691 57,971
Issue of share capital on exercise of options - 188,125 2 - - 6 8
Issue of share capital on exercise of warrants - 1,278,570 13 - (13) 345 345
Ordinary and deferred shares as at 31 July 2021 2,025,000 227,812,697 2,278 2,025 979 53,042 58,324
Issue of share capital on exercise of options - - - - - - -
Issue of share capital on exercise of warrants - 1,100,000 11 - (11) 297 297
Ordinary and deferred shares as at 31 January 2022 2,025,000 228,912,697 2,289 2,025 968 53,339 58,621
6. Interim financial report
A copy of this interim condensed financial report is available on C4XD's
website at www.c4xdiscovery.com (http://www.c4xdiscovery.com) .
This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
or visit
www.rns.com (http://www.rns.com/)
.
RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
. END IR UBANRUSUSUARRecent news on C4X Discovery Holdings
See all newsREG - AIM C4X Discovery - Cancellation - C4X Discovery Holdings plc
AnnouncementREG - C4X Discovery - Last day of dealings and update on cancellation
AnnouncementREG - C4X Discovery - Holding(s) in Company
AnnouncementREG - FTSE Russell C4X Discovery - C4X Discovery Holdings
AnnouncementREG - C4X Discovery - Result of General Meeting
Announcement