This announcement contains inside information
("C4XD", "C4X Discovery" or the "Company")
Half-year results for the six months ended
Up to
Future strategic focus to deliver high value small molecules to treat immuno-inflammatory diseases
Launched PatientSeek, a Precision Medicine platform for optimised patient selection based on its Taxonomy3® genetic analysis technology
Dr
"C4XD has continued to make significant strides across our portfolio during the period, culminating in our third global out-licensing deal, this time with AstraZeneca for our NRF2 Activator programme worth up to
"I'm excited that following a review of our expertise and previous successes, our strategy is now focused on treatments for immuno-inflammatory diseases. With our proven expertise in drug discovery and our rigorous approach to programme development, we believe that a more focused approach on immuno-inflammatory diseases will allow us to harness our skillset and take the development of our programmes further, providing greater value for shareholders."
Operational Highlights (including post-period events)
- Indivior's Phase 1 multiple ascending dose clinical trial of C4XD's oral Orexin-1 receptor antagonist, C4X_3256 (INDV-2000), for substance use disorder is ongoing.
- Sanofi is progressing C4XD's IL-17A inhibitor programme for inflammatory diseases towards the next milestone.
- C4XD signed an exclusive worldwide licensing agreement with AstraZeneca in
November 2022 , worth up to$402 million , for its NRF2 Activator programme. - α4β7 integrin inhibitor programme for inflammatory bowel disease delivered compounds showing improved activity at a lower dose compared to example competitor clinical compounds in a pharmacodynamic model after oral dosing.
- MALT-1 inhibitor programme for cancer examined a lead compound in a mouse xenograft study that showed equivalent efficacy at equivalent dose to the Johnson & Johnson clinical compound JnJ-67856633 (in Phase 1) and the project is moving forward to identification of candidate shortlist molecules.
- C4XD internal portfolio expanded in inflammatory diseases and new programmes identified to progress into Lead Optimisation and beyond.
- C4XD launched PatientSeek, a Precision Medicine platform for optimised patient selection based on its Taxonomy3® genetic analysis technology, following key results from a collaboration with
Australia's Garvan Institute of Medical Research ("Garvan Institute "). - Dr
Nick Ray has been appointed as Chief Scientific Officer.
Financial Highlights
- Revenue was £1.7 million (
January 2022 : £0.1 million) - Total loss after tax of £3.9 million or
1.55 pence per share (January 2022 : £4.5m or1.98 pence per share) - R&D expenses was £5.2 million (
January 2022 : £3.9m), reflecting focused investment in key Drug Discovery programmes - Net assets of £13.6 million (
January 2022 : £15.2m) - Net cash as at
31 January 2023 : £9.6 million (31 January 2022 : £11.7m)
Analyst webcast and conference call today
Dr
https://www.lsegissuerservices.com/spark/C4xDiscoveryHolding/events/d062ff53-5db5-4b93-a428-089daeee0030
A copy of the final results presentation will be released later this morning on the Company website at www.c4xdiscovery.com.
1. Total deal value calculation based on exchange rates at the time of each deal.
- Ends -
Contacts
+44 (0)787 6444977 | |
+44 (0)20 7886 2500 | |
C4X Discovery Media - | |
+44 (0)203 709 5700 |
Notes to Editors:
About
For more information visit us at www.c4xdiscovery.com or follow us on twitter @C4XDiscovery.
Corporate Overview
We have continued to make strong progress across the entire portfolio, both during the period and into the beginning of 2023. Our most significant news was announced in November with the out-licensing of our NRF2 Activator programme to AstraZeneca for up to
Our portfolio of partnered programmes continues to advance. Indivior's Phase I multiple-ascending dose clinical trial of C4XD's Orexin 1 Antagonist candidate C4X_3256/INDV-2000 is underway and, following the first milestone received from Sanofi, our IL-17A Inhibitor programme is advancing through pre-clinical studies towards the next milestone. We look forward to hearing how these programmes progress throughout the year.
Following a review of our expertise and previous successes, C4XD is evolving its strategy to become a company focused on treatments for immuno-inflammatory diseases. With the majority of our portfolio already focused on immuno-inflammatory diseases, a proven drug discovery expertise and an expert team of scientists who understand this disease area, we believe that with this approach we can harness our skillset and take the development of our programmes further, providing greater value for shareholders.
Our internal portfolio will now focus on the discovery and development of novel small molecule medicines with Best-in-Class and First-in-Class potential to treat patients across a range of immuno-inflammatory diseases. Our lead internal programme, focused on oral small molecule inhibitors of α4β7, has the potential to expand patient access to α4β7 inhibitor therapy for the treatment of inflammatory bowel disease ("IBD"). This programme is making significant headway through late-stage discovery and progressing towards pre-clinical studies. We have further immuno-inflammatory programmes in early discovery and we anticipate moving the two most promising of these into Lead Optimisation within the next 18 months.
In line with our new focus on immuno-inflammatory diseases, the decision has been taken to streamline our portfolio and prioritise resources, and we therefore plan to out-license our pre-clinical MALT-1 inhibitor programme for oncology.
In
In
The Company has a sufficient cash position and manageable fixed cost base. Cash, cash equivalents, short-term investments and deposits were £9.6 million at
Portfolio Review
Addictive disorders (Orexin-1 Antagonist) - out-licensed to Indivior
Phase 1 multiple ascending dose study ongoing
Under C4XD's milestone and royalties agreement with Indivior worth up to
Opioid addiction is an increasing burden on the healthcare system, particularly in the US but is a growing global issue. According to the
Inflammation (IL-17A Inhibitor) - out-licensed to Sanofi
Sanofi-led programme making significant progress
Under the exclusive worldwide licensing agreement worth up to €414 million, Sanofi continues to make strong pre-clinical progress towards the second milestone; C4XD received the first milestone payment of €3 million in
Inflammation (NRF2 Activator) - out-licensed to AstraZeneca
Programme continues to move forward under AstraZeneca's ownership
C4XD signed an exclusive worldwide licensing agreement with AstraZeneca in
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.
Inflammation (α4β7 Integrin Inhibitor)
Programme transitioned into Lead Optimisation
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 has been demonstrated and there is particular focus on improving PK properties to achieve a good oral half-life. C4XD has compounds that match or exceed both whole blood potency and selectivity values when compared to examples from current clinical patent estates, with correspondingly improved activity at a lower dose when profiled in a T-cell gut-homing pharmacodynamic model.
Haematological Cancer (MALT1 Inhibitor)
Moving towards identification of pre-clinical candidate shortlist
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 and Bcl inhibitors across multiple haematological indications, as well as broader potential in solid tumours and inflammation.
Our Conformetrix technology has yielded multiple structurally distinct series, two of which have progressed into Lead Optimisation. Profiling of a Lead compound in a mouse xenograft study has shown equivalent efficacy at equivalent dose to the Johnson & Johnson clinical compound JnJ-67856633 (in Phase 1) and the programme is moving forward to identification of candidate shortlist molecules. C4XD has initiated partnering discussions for this programme.
Expansion of Pipeline
As we look to scale our portfolio, early-phase programmes targeting a number of targets across a range of immuno-inflammatory diseases are being resourced to identify those with the highest potential to warrant increased spend and prosecution to and through Lead Optimisation and eventually into the clinic. These programmes target clear unmet medical need, combined with significant commercial potential and a unique opportunity to produce valuable chemical equity through interpretation of conformational insight via C4XD's Conformetrix technology. Additionally, we are using our PatientSeek platform (vide infra) to inform our target selection choices, based on identification of patient stratification opportunities and improved trial design. Details of each programme will be provided once they have matured to Lead Optimisation stage.
PatientSeek
C4XD has launched a precision medicine platform, PatientSeek, based on its Taxonomy3® technology, following insights from a successful research collaboration with
Outlook
C4XD has continued to make huge strides across our portfolio during the period, including our third global out-licensing deal, this time with AstraZeneca for our NRF2 Activator programme worth up to
1. https://www.indivior.com/resources/dam/id/1147/Annual%20Report%20and%20Accounts%202022.pdf
2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4530463/
3. Plaque Psoriasis: Global Drug Forecast and Market Analysis to 2027, GlobalData,
Interim consolidated statement of comprehensive income
For the six months ended
Six months | Six months | Year | |||||
to | to | to | |||||
31 July 2022 | |||||||
(Unaudited) | (Unaudited) | (Audited) | |||||
£000 | £000 | £000 | |||||
Notes | |||||||
Revenue | 3 | 1,676 | 66 | 2,699 | |||
Cost of sales | (22 | ) | (59 | ) | (130 | ) | |
Gross profit | 1,654 | 7 | 2,569 | ||||
Research and development expenses | (5,194 | ) | (3,942 | ) | (9,426 | ) | |
Administrative expenses | (1,638 | ) | (1,595 | ) | (3,665 | ) | |
Operating loss | (5,178 | ) | (5,530 | ) | (10,522 | ) | |
Finance income | 15 | - | - | ||||
Finance costs | (12 | ) | (7 | ) | (12 | ) | |
Loss before taxation | (5,175 | ) | (5,537 | ) | (10,534 | ) | |
Taxation | 4 | 1,296 | 1,020 | 2,374 | |||
Loss for the period and total comprehensive loss for the period | (3,879 | ) | (4,517 | ) | (8,160 | ) | |
Loss per share: | |||||||
Basic loss for the period | 5 | (1.55)p | (1.98)p | (3.57)p | |||
Diluted loss for the period | 5 | (1.55)p | (1.98)p | (3.57)p |
Interim consolidated statement of changes in equity
For the six months ended
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 | 4,302 | 53,043 | 979 | 1,191 | 920 | 195 | (41,344 | ) | 19,286 | |||
Loss for the six months to | - | - | - | - | - | - | (4,517 | ) | (4,517 | ) | ||
Issue of share capital | - | - | - | - | - | - | - | - | ||||
Expenses of options | - | - | - | - | - | - | - | - | ||||
Exercise of warrants | 11 | 297 | (11 | ) | - | - | - | 11 | 308 | |||
Share-based payments | - | - | - | 114 | - | - | - | 114 | ||||
At | 4,313 | 53,340 | 968 | 1,305 | 920 | 195 | (45,850 | ) | 15,191 | |||
Loss for the six months to | - | - | - | - | - | - | (3,643 | ) | (3,643 | ) | ||
Issue of share capital | - | - | - | - | - | - | - | - | ||||
Exercise of options | 3 | 15 | - | - | - | - | - | 18 | ||||
Exercise of warrants | - | - | - | - | - | - | - | - | ||||
Share-based payments | - | - | - | 238 | - | - | - | 238 | ||||
At | 4,316 | 53,355 | 968 | 1,543 | 920 | 195 | (49,493 | ) | 11,804 | |||
Loss for the six months to | - | - | - | - | - | - | (3,879 | ) | (3,879 | ) | ||
Issue of share capital | 228 | 5,467 | - | - | - | - | - | 5,695 | ||||
Expenses of placing | - | (287 | ) | - | - | - | - | - | (287 | ) | ||
Exercise of options | 1 | 5 | - | - | - | - | - | 6 | ||||
Exercise of warrants | - | - | - | - | - | - | - | - | ||||
Share-based payments | - | - | - | 214 | - | - | - | 214 | ||||
At | 4,545 | 58,540 | 968 | 1,757 | 920 | 195 | (53,372 | ) | 13,553 |
Interim consolidated statement of financial position
As at
(Unaudited) | (Unaudited) | (Audited) | |||||
Notes | £000 | £000 | £000 | ||||
Assets | |||||||
Non-current assets | |||||||
Property, plant and equipment | 43 | 30 | 47 | ||||
Intangible assets | 59 | 67 | 61 | ||||
1,192 | 1,192 | 1,192 | |||||
Right-of-use assets | 563 | 266 | 707 | ||||
1,857 | 1,555 | 2,007 | |||||
Current assets | |||||||
Trade and other receivables | 567 | 571 | 3,069 | ||||
Income tax asset | 3,661 | 3,073 | 4,427 | ||||
Cash and cash equivalents | 9,642 | 11,679 | 5,079 | ||||
13,870 | 15,323 | 12,575 | |||||
Total assets | 15,727 | 16,878 | 14,582 | ||||
Liabilities | |||||||
Current liabilities | |||||||
Trade and other payables | (1,587 | ) | (1,390 | ) | (2,049 | ) | |
Lease liabilities | (329 | ) | (171 | ) | (305 | ) | |
(1,916 | ) | (1,561 | ) | (2,354 | ) | ||
Non-current liabilities | |||||||
Trade and other payables | - | - | - | ||||
Lease liabilities | (258 | ) | (126 | ) | (424 | ) | |
(258 | ) | (126 | ) | (424 | ) | ||
Total liabilities | (2,174 | ) | (1,687 | ) | (2,778 | ) | |
Net assets | 13,553 | 15,191 | 11,804 | ||||
Capital and reserves | |||||||
Issued equity capital | 6 | 4,545 | 4,314 | 4,316 | |||
Share premium | 6 | 58,540 | 53,339 | 53,355 | |||
Share-based payment reserve | 1,757 | 1,305 | 1,543 | ||||
Warrant reserve | 968 | 968 | 968 | ||||
Merger reserve | 920 | 920 | 920 | ||||
Capital contribution reserve | 195 | 195 | 195 | ||||
Revenue reserve | (53,372 | ) | (45,850 | ) | (49,493 | ) | |
Total equity | 13,553 | 15,191 | 11,804 |
Approved by the Board and authorised for issue on
Chief Financial Officer
Interim consolidated cash flow statement
For the six months ended
Six months | Six months | Year | ||||
to | to | to | ||||
31 January | 31 January | 31 July | ||||
2023 | 2022 | 2022 | ||||
(Unaudited) | (Unaudited) | (Audited) | ||||
£000 | £000 | £000 | ||||
Loss after tax and interest | (3,879 | ) | (4,517 | ) | (8,160 | ) |
Adjustments for: | ||||||
Depreciation of property, plant and equipment | 12 | 12 | 23 | |||
Depreciation of right-of-use assets | 143 | 111 | 212 | |||
Amortisation of intangible assets | 3 | 3 | 8 | |||
Share-based payments | 214 | 114 | 352 | |||
Finance income | (15 | ) | - | - | ||
Finance costs | 12 | 7 | 12 | |||
Taxation | (1,296 | ) | (1,020 | ) | (2,374 | ) |
Changes in working capital: | ||||||
Decrease/(increase) in trade and other receivables | 2,502 | 3 | (2,496 | ) | ||
(Decrease)/increase in trade and other payables | (462 | ) | (321 | ) | 338 | |
Cash outflow from operating activities | (2,766 | ) | (5,608 | ) | (12,085 | ) |
Research and development tax credit received | 2,063 | - | - | |||
Net cash outflow from operating activities | (703 | ) | (5,608 | ) | (12,085 | ) |
Cash flows from investing activities: | ||||||
Purchases of property, plant and equipment | (8 | ) | (10 | ) | (36 | ) |
Finance income | 15 | - | - | |||
Net cash outflow from investing activities | 7 | (10 | ) | (36 | ) | |
Cash flows from financing activities: | ||||||
Payment of lease liabilities | (155 | ) | (114 | ) | (229 | ) |
Proceeds from the issue of ordinary share capital | 5,701 | 308 | 326 | |||
Expenses of placing | (287 | ) | - | - | ||
Net cash inflow from financing activities | 5,259 | 194 | 97 | |||
Increase/(decrease) in cash and cash equivalents | 4,563 | (5,424 | ) | (12,024 | ) | |
Cash and cash equivalents at the start of the period | 5,079 | 17,103 | 17,103 | |||
Cash, cash equivalents and deposits at the end of the period | 9,642 | 11,679 | 5,079 |
Notes to the interim financial report
For the six months ended
1. Corporate information
The principal activity of the
C4XD is incorporated and domiciled in the
The interim financial information was approved for issue on
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
The interim financial information for the six months ended
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
Basis of consolidation
This interim financial report consolidates the financial statements of
3. Revenue
Six months to | Six months to | Year to | |
31 January | 31 January | 31 July | |
2023 | 2022 | 2022 | |
£000 | £000 | £000 | |
Revenue recognised at a point in time - Right-to-use licence revenue - Milestone revenue | 1,652 - | - - | - 2,555 |
Revenue recognised over time - Research services revenue - Consultancy services | 24 - | 66 - | 144 - |
Total Revenue | 1,676 | 66 | 2,699 |
Revenue in the current period has been generated from contracts with two customers.
In the current period a new contract was signed with a new customer which has been determined to have three performance obligations - the transfer of intellectual property which has been recognised as right-to-use licence revenue at a single point in time; the provision of consultancy and technical support which will be recognised over time in line with the level of consultancy provided; and the facility of on-going research which will be reimbursed on a pass-through cost basis.
The revenue attributed to the delivery of research services was generated from one customer and is recognised over time. The progress is measured based on costs incurred to date as compared with the total projected costs for both the current and prior periods.
Revenue In the prior periods was generated from a contract with a single customer. In the prior period, the milestone revenue was determined to have one performance obligation and was recognised at a point in time. The revenue attributed to the delivery of research services was recognised on the same basis as in the current period.
4. Taxation
Six months to | Six months to | Year to | ||||
31 January | 31 January | 31 July | ||||
2023 | 2022 | 2022 | ||||
£000 | £000 | £000 | ||||
- | - | - | ||||
Research and development income tax credit receivable | (1,296 | ) | (1,020 | ) | (2,365 | ) |
Adjustment in respect of prior periods | - | - | (9 | ) | ||
(1,296 | ) | (1,020 | ) | (2,374 | ) |
5. Loss per share
31 January | 31 January | 31 July | |
2023 | 2022 | 2022 | |
£000 | £000 | £000 | |
Loss for the financial period attributable to equity shareholders | (3,879) | (4,517) | (8,160) |
Weighted average number of shares: | No. | No. | No. |
Ordinary shares in issue | 250,048,502 | 228,177,371 | 228,675,845 |
Number of exercisable share options and warrants | 305,197 | 22,005,021 | 12,231,972 |
Ordinary shares in issue for purposes of diluted EPS | 250,353,700 | 250,182,392 | 240,907,817 |
Basic and diluted loss per share (pence) | (1.55)p | (1.98)p | (3.57)p |
The number of exercisable share options and warrants above are those deemed to be potentially dilutive in nature as their exercise price is less than the average share price for the period. As the group made a loss in the current and comparative period the effects of these potential ordinary shares are not dilutive.
6. 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 | 2,025,000 | 228,912,697 | 2,289 | 2,025 | 968 | 53,339 | 58,621 | ||
Issue of share capital on exercise of options | - | 319,275 | 3 | - | - | 15 | 18 | ||
Ordinary and deferred shares as at | 2,025,000 | 229,231,972 | 2,292 | 2,025 | 968 | 53,354 | 58,639 | ||
Issue of share capital on placing | - | 22,781,200 | 228 | - | - | 5,467 | 5,695 | ||
Issue of share capital on exercise of options | - | 106,425 | 1 | - | - | 5 | 6 | ||
Expenses of placing | - | - | - | - | - | (287 | ) | (287 | ) |
Ordinary and deferred shares as at | 2,025,000 | 252,119,597 | 2,521 | 2,025 | 968 | 58,539 | 64,053 |
7. Interim financial report
A copy of this interim condensed financial report is available on C4XD's website at www.c4xdiscovery.com.
Source:
2023 GlobeNewswire, Inc., source