CELYAD ONCOLOGY SA | ||||||
Date: August 5, 2022 |
By: |
/s/ Michel Lussier | ||||
Michel Lussier | ||||||
Interim Chief Executive Officer |
Exhibit 99.1
Regulated Information
Celyad Oncology Reports First Half 2022 Financial Results and Recent Business Highlights
August 5, 2022, 7:00 a.m. CEST
| Enrollment ongoing in Phase 1 dose-escalation IMMUNICY-1 trial for lead shRNA-based allogeneic CAR T candidate, CYAD-211, for relapsed/refractory (r/r) multiple myeloma (MM) |
| In July 2022, the U.S. Food and Drug Administration (FDA) lifted the clinical hold for the T-cell-inhibitory-molecule (TIM)-based allogeneic CAR T candidate CYAD-101 for metastatic colorectal cancer (mCRC) |
| Company to increase strategic focus on collaborations related to broad intellectual property portfolio |
| Conference call and webcast scheduled for today, August 5th, at 2:00 p.m. CEST / 8:00 a.m. EDT |
Mont-Saint-Guibert, Belgium Celyad Oncology SA (Euronext & Nasdaq: CYAD) (the Company), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, today announced an update on its financial results and recent business developments for the first half ended June 30, 2022.
As the Company continues to evolve, we are excited about a renewed focus on additional value drivers for Celyad Oncology. Importantly, with our world-class intellectual property focused on allogeneic CAR T technology, we have multiple opportunities for partnerships with peers in the industry, commented Michel Lussier, interim Chief Executive Officer of Celyad Oncology. We also were proud to recently announce that the FDA lifted the clinical hold on our CYAD-101 program. In addition, we look forward to the upcoming data read out for CYAD-211 in the second half of 2022. We are truly ushering in a new chapter for Celyad Oncology by unlocking the potential of not only our product candidates, but also our portfolio of IP, technology, and overall expertise in cell therapy.
Second Quarter 2022 and Recent Business Highlights
| The Board of Directors named Hilde Windels as Chair of the Board of Directors |
| Michel Lussier named Interim Chief Executive Officer of the Company |
Pipeline and Business Updates
CYAD-211 Allogeneic shRNA-based, anti-BCMA CAR T for r/r MM
CYAD-211 is an investigational, short hairpin RNA (shRNA)-based allogeneic CAR T candidate for the treatment of r/r MM. CYAD-211 is engineered to co-express a B cell maturation antigen (BCMA) targeting CAR and a single shRNA, which interferes with the expression of the CD3z component of the T-cell receptor (TCR) complex.
| Preliminary data reported in December 2021 from the dose-escalation segment of the IMMUNICY-1 Phase 1 trial evaluating CYAD-211 following cyclophosphamide/fludarabine (CyFlu) preconditioning chemotherapy in patients with r/r MM showed evidence of clinical activity with a good tolerability profile including no evidence of Graft versus Host Disease. In addition, all patients in the trial had detectable CYAD-211 cells in the peripheral blood. |
| Enrollment is currently ongoing in the IMMUNICY-1 Phase 1 trial to evaluate enhanced lymphodepletion (eLD) and increased CYAD-211 doses with the aim to improve cell persistence and potentially maximize the clinical benefit of CYAD-211. The IMMUNICY-1 protocol also allows for CYAD-211 redosing in certain patients. |
| Additional data updates from the eLD cohorts of the Phase 1 IMMUNICY-1 trial of CYAD-211 for r/r MM are expected during second half of 2022. |
CYAD-101 Allogeneic TIM-based NKG2D CAR T for mCRC
CYAD-101 is an investigational, non-gene edited, allogeneic CAR T candidate engineered to co-expresses the TIM peptide alongside a CAR based on NKG2D, a receptor expressed on natural killer (NK) and T cells, that binds to eight stress-induced ligands.
| In June 2022 we submitted our complete response to the clinical hold of the CYAD-101-002 phase 1b trial to the FDA stating our intent to amend the eligibility criteria to exclude patients who have bilateral lung metastases and patients who have received treatment with epidermal growth factor receptor (EGFR) targeting monoclonal antibodies within the previous 9 months prior to trial recruitment. In July 2022, based on that complete response, we received notification that the FDA lifted the clinical hold on the CYAD-101-002 phase 1b trial |
Celyad Oncology SA | Rue Édouard Belin 2, 1435 Mont-Saint-Guibert, Belgium | +32 10 39 41 00
shARC Platform
Discovery research continues on programs focused on the co-expression of Interleukin-18 in conjunction with our short hairpin RNA shRNA technology platform, also known as our shARC (shRNA Armored CAR) franchise, with a focus on the development of next-generation, allogeneic CAR T candidates.
CYAD-02 Autologous NKG2D CAR-T for r/r AML and MDS
CYAD-02 is an investigational, autologous CAR T therapy that co-expresses both the NKG2D CAR and a single shRNA targeting the NKG2D ligands MICA/MICB on the CAR T cells.
| In December 2021, the Company presented clinical results from the dose-escalation CYCLE-1 Phase 1 trial evaluating CYAD-02 for the treatment of r/r acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Data from the trial showed that a single shRNA can target two independent genes (MICA/MICB) to enhance the phenotype of the CAR T cells. In addition, the dual knockdown showed a positive contribution to the initial clinical activity of CYAD-02 as well as a trend towards increased engraftment and persistence compared to the first-generation, autologous NKG2D receptor CAR T. |
| The Company continues to explore potential partnership opportunities for the future development of CYAD-02. |
Strategic Focus on Intellectual Property
The Company maintains a robust intellectual property portfolio within the landscape of CAR T, including twelve foundational U.S.
patents associated with allogeneic CAR T for the treatment of cancer as well as patents for NKG2D receptor-based cell therapies. We believe these patents provide an avenue for the Company to develop its own programs as well as to seek potential partnership opportunities.
First Half 2022 Financial Results
Key financial figures for the first half of 2022, compared with the first half of 2021 and full year 2021, are summarized below:
Selected key financial figures ( millions) |
Half Year 30 June 2022 |
Half Year 30 June 2021 |
Full Year 31 December 2021 |
|||||||||
Revenue |
| | | |||||||||
Research and development expenses |
(10.5 | ) | (10.0 | ) | (20.8 | ) | ||||||
General and administrative expenses |
(6.2 | ) | (4.8 | ) | (9.9 | ) | ||||||
Change in fair value of contingent consideration |
1.1 | (2.0 | ) | 0.8 | ||||||||
Other income/(expenses) |
1.6 | 1.8 | 3.4 | |||||||||
Operating loss |
(14.1 | ) | (14.9 | ) | (26.4 | ) | ||||||
Loss for the period/year |
(14.1 | ) | (14.9 | ) | (26.5 | ) | ||||||
Net cash used in operations |
(16.3 | ) | (12.2 | ) | (26.6 | ) | ||||||
Cash and cash equivalents |
14.4 | 12.0 | 30.0 |
Research and Development expenses were 10.5 million for the first half of 2022, compared to 10.0 million for the first half of 2021. The 0.5 million increase was mainly driven by intellectual property filing and maintenance fees to strengthen intellectual property prosecution and the increase of employee expenses mainly related to the full expense impact of the employees recruited during 2021 to support the Groups preclinical and clinical programs, employee turnover and management changes, both of which were partially offset by the decrease in clinical activities resulting from the Phase 1b CYAD-101-002 (KEYNOTE-B79) trial which was on clinical hold during the second quarter of 2022.
General and Administrative expenses were 6.2 million for the first half of 2022, compared to 4.8 million for the first half of 2021. This increase is primarily attributable to an increase in insurance costs for the period, combined with an increase in employee expenses mainly related to management changes through the six-month period ended June 30, 2022.
A fair value adjustment of 1.1 million (non-cash income) related to the reassessment of the contingent consideration and other financial liabilities associated with the advancement of the Companys NKG2D-based CAR T candidates as of June 30, 2022, required by International Financial Reporting Standards (IFRS), was mainly driven by the updated assumptions on projected revenue associated with the Companys CYAD-101 program, for which the timing of the potential commercialization has been delayed by one year. Additionally, the addressable patient population for CYAD-101 has been reduced based on recent safety findings from the CYAD-101-002 Phase 1b trial. The fair value adjustment was also driven by updated assumptions to discount rate and revaluation of the U.S. dollar foreign exchange rate.
The Company also posted 1.6 million in net other income for the first half of 2022, compared to a net other income of 1.8 million for the first half of 2021. Other income for the first half of 2022 is primarily due to grant income from the Walloon Region of 1.4 million.
Net loss for the first half of 2022 was 14.1 million, or (0.62) per share, compared to a net loss of 14.9 million, or (1.02) per share, for the first half of 2021.
Net cash used in operations was 16.3 million for the first half of 2022, compared to 12.2 million for the first half of 2021.
As of June 30, 2022, the Company had cash and cash equivalents of 14.4 million ($15.0 million).
As of June 30, 2022, the total number of basic shares outstanding were 22.6 million similar to December 31, 2021.
Celyad Oncology First Half 2022 Conference Call Details
Date: Friday, August 5, 2022
Time: 2 p.m. CEST / 8 a.m. EDT
Dial-in: +1 201 493 6779 (International), + 1 877 407 9716 (United States) or +32 (0) 800 73 904 (Belgium). Please ask to be joined into the Celyad Oncology SA call.
The conference call will be webcast live and archived within the Events section of the Celyad Oncology website.
About Celyad Oncology
Celyad Oncology is a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer. The Company is developing a pipeline of allogeneic (off-the-shelf) and autologous (personalized) CAR T cell therapy candidates for the treatment of both hematological malignancies and solid tumors. Celyad Oncology was founded in 2007 and is based in Mont-Saint-Guibert, Belgium and New York, NY. The Company has received funding from the Walloon Region (Belgium) to support the advancement of its CAR T cell therapy programs. For more information, please visit www.celyad.com.
Forward-Looking Statement
This release may contain forward-looking statements, within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, without limitation, statements regarding: Celyad Oncologys ability to leverage its intellectual property to develop programs and seek potential partnership opportunities, the continued development of Celyad Oncologys TIM technology, the lifting of the clinical hold on CYAD-101-002 trial, the timing and outcomes of additional data from Phase 1 IMMUNICY-1 trial of CYAD-211, safety and clinical activity of the product candidates in Celyad Oncologys pipeline, Celyad Oncologys ability to effectively leverage its intellectual property portfolio, Celyad Oncologys financial condition and cash runway, and expected results of operations and business outlook. The words may, might, will, could, would, should, plan, anticipate, intend, believe, expect, estimate, future, potential, continue, target and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements may involve known and unknown risks and uncertainties which might cause actual results, financial condition, performance or achievements of Celyad Oncology to differ materially from those expressed or implied by such forward-looking statements. Such risk and uncertainty include, without limitation: Celyad Oncologys ability to continue to access to the equity purchase agreement with Lincoln Park Capital Fund, LLC, our financial and operating results, the duration and severity of the COVID-19 pandemic, and global economic uncertainty, including with respect to geopolitical conditions and attendant sanctions resulting from the conflict in Ukraine. A further list and description of these risks, uncertainties and other risks can be found in Celyad Oncologys U.S. Securities and Exchange Commission (SEC) filings and reports, including in its Annual Report on Form 20-F filed with the SEC on March 24, 2022 and subsequent filings and reports by Celyad Oncology. These forward-looking statements speak only as of the date of publication of this document and Celyad Oncologys actual results may differ materially from those expressed or implied by these forward-looking statements. Celyad Oncology expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless required by law or regulation.
Investor and Media Contacts:
Sara Zelkovic
Communications & Investor Relations Director
Celyad Oncology
investors@celyad.com
Source: Celyad Oncology SA
Celyad Oncology SA
Interim Consolidated Statement of Comprehensive Income (Unaudited)
(000) | For the Six-month period ended June 30, |
For the Six-month period ended June 30, |
||||||
2022 | 2021 | |||||||
Revenue |
| | ||||||
Cost of sales |
| | ||||||
Gross profit |
| | ||||||
Research and Development expenses |
(10 527 | ) | (9 956 | ) | ||||
General & Administrative expenses |
(6 245 | ) | (4 785 | ) | ||||
Change in fair value of contingent consideration |
1 128 | (1 961 | ) | |||||
Other income |
1 781 | 1 987 | ||||||
Other expenses |
(214 | ) | (162 | ) | ||||
Operating Loss |
(14 077 | ) | (14 877 | ) | ||||
Financial income |
148 | 166 | ||||||
Financial expenses |
(127 | ) | (143 | ) | ||||
Loss before taxes |
(14 056 | ) | (14 854 | ) | ||||
Income taxes |
| | ||||||
Loss for the period |
(14 056 | ) | (14 854 | ) | ||||
Basic and diluted loss per share (in ) |
(0.62 | ) | (1.02 | ) | ||||
|
|
|
|
|||||
Other comprehensive income/(loss) |
||||||||
Items that will not be reclassified to profit and loss |
| | ||||||
Remeasurement of post-employment benefit obligations, net of tax |
| | ||||||
Items that may be subsequently reclassified to profit or loss |
(9 | ) | 14 | |||||
Currency translation differences |
(9 | ) | 14 | |||||
Other comprehensive income / (loss) for the period, net of tax |
(9 | ) | 14 | |||||
|
|
|
|
|||||
Total comprehensive loss for the period |
(14 065 | ) | (14 840 | ) | ||||
Total comprehensive loss for the period attributable to Equity Holders |
(14 065 | ) | (14 840 | ) | ||||
|
|
|
|
Celyad Oncology SA
Interim Consolidated Statement of Financial Position (Unaudited)
(000) | June 30, | December 31, | ||||||
2022 | 2021 | |||||||
NON-CURRENT ASSETS |
43 760 | 45 651 | ||||||
Goodwill and Intangible assets |
36 589 | 36 168 | ||||||
Property, Plant and Equipment |
2 855 | 3 248 | ||||||
Non-current Trade and Other receivables |
| 2 209 | ||||||
Non-current Grant receivables |
4 094 | 3 764 | ||||||
Other non-current assets |
222 | 262 | ||||||
CURRENT ASSETS |
19 380 | 34 292 | ||||||
Trade and Other Receivables |
757 | 668 | ||||||
Current Grant receivables |
2 814 | 1 395 | ||||||
Other current assets |
1 424 | 2 211 | ||||||
Short-term investments |
| | ||||||
Cash and cash equivalents |
14 385 | 30 018 | ||||||
|
|
|
|
|||||
TOTAL ASSETS |
63 140 | 79 943 | ||||||
|
|
|
|
|||||
EQUITY |
30 650 | 43 639 | ||||||
Share Capital |
78 585 | 78 585 | ||||||
Share premium |
6 317 | 6 317 | ||||||
Other reserves |
34 239 | 33 172 | ||||||
Capital reduction reserve |
234 562 | 234 562 | ||||||
Accumulated deficit |
(323 053 | ) | (308 997 | ) | ||||
NON-CURRENT LIABILITIES |
21 134 | 22 477 | ||||||
Bank loans |
| | ||||||
Lease liabilities |
1 381 | 1 730 | ||||||
Recoverable Cash advances (RCAs) |
5 971 | 5 851 | ||||||
Contingent consideration payable and other financial liabilities |
13 551 | 14 679 | ||||||
Post-employment benefits |
53 | 53 | ||||||
Other non-current liabilities |
178 | 164 | ||||||
CURRENT LIABILITIES |
11 356 | 13 827 | ||||||
Bank loans |
| | ||||||
Lease liabilities |
783 | 902 | ||||||
Recoverable Cash advances (RCAs) |
669 | 362 | ||||||
Trade payables |
6 008 | 6 611 | ||||||
Other current liabilities |
3 896 | 5 952 | ||||||
|
|
|
|
|||||
TOTAL EQUITY AND LIABILITIES |
63 140 | 79 943 | ||||||
|
|
|
|
Forward-looking statements |
2 | |||||
1. |
Interim Management Report | 4 | ||||
1.1 |
Management’s discussion and analysis of financial condition and results of operations |
4 | ||||
1.2 |
Risks and uncertainties |
10 | ||||
2. |
Unaudited Condensed Consolidated Interim Financial Statements – Six-month period ended June 30, 2022 |
13 | ||||
2.1 |
Unaudited interim consolidated statement of Financial Position |
13 | ||||
2.2 |
Unaudited interim consolidated statement of comprehensive income |
14 | ||||
2.3 |
Unaudited interim consolidated statement of changes in equity |
15 | ||||
2.4 |
Unaudited interim consolidated statement of cash flows |
16 | ||||
2.5 |
Notes to the unaudited condensed consolidated interim financial statements – Six-month period ended June 30, 2022 |
17 | ||||
2.5.1 |
General Information |
17 | ||||
2.5.2 |
Basis of preparation and significant accounting policies |
17 | ||||
2.5.3 |
Segment reporting |
19 | ||||
2.5.4 |
Off-Balance Sheet Commitments |
20 | ||||
2.5.5 |
Capital Expenditures |
20 | ||||
2.5.6 |
Results of Operations |
20 | ||||
2.5.7 |
Liquidity and capital resources |
23 | ||||
2.5.8 |
Goodwill and Intangible assets |
24 | ||||
2.5.9 |
Non-current trade receivables and other non-current assets |
25 | ||||
2.5.10 |
Trade and Other receivables |
26 | ||||
2.5.11 |
Short-term investments and Cash and Cash equivalents |
26 | ||||
2.5.12 |
Capital and share premium |
26 | ||||
2.5.13 |
Recoverable Cash Advances |
27 | ||||
2.5.14 |
Other Non-Current liabilities |
28 | ||||
2.5.15 |
Trade payables and other current liabilities |
28 | ||||
2.5.16 |
Financial Instruments fair values disclosures |
28 | ||||
2.5.17 |
Leases |
31 | ||||
2.5.18 |
Related party transactions |
33 | ||||
2.5.19 |
Subsequent events |
33 | ||||
3. |
Responsibility Statement | 34 | ||||
4. |
Financial Calendar & Celyad Oncology Contact Details | 35 |
1. |
Interim Management Report |
1.1 |
Management’s discussion and analysis of financial condition and results of operations |
• | Short hairpin RNA (shRNA). z , a key component of the TCR complex. This results in durable high-level knockdown of the TCR on T cells to a level equivalent to that seen if the CD3z gene was gene edited with CRISPR/Cas9. In preclinical experiments, the persistence of non-CAR-bearing beta-2-microglobulin PD-1, MICA/MICB and the intracellular lipid kinase diacylglycerol kinase (DGK). In addition, we have demonstrated concurrent knockdown of multiple gene targets, or multiplexing, using our shRNA technology platform. |
• | T cell Inhibitory Molecule (TIM). z component of the TCR complex which lacks the critical signaling domains of the wild-type CD3z . In our allogeneic CAR T candidate CYAD-101, TIM is co-expressed with a NKG2D CAR to reduce the potential of the TCR to induce GvHD. Following the expression of TIM, the peptide acts as a competitive inhibitor to wild-type CD3z and is incorporated into the TCR complex. |
• | Enrollment continues in Phase 1 dose-escalation IMMUNICY-1 trial for lead shRNA-based allogeneic CAR T candidate, CYAD-211, for relapsed/refractory multiple myeloma (r/r MM). |
• | In February 2022, we voluntarily paused the Phase 1b CYAD-101-002 CYAD-101 after two fatalities occurred that presented with similar pulmonary findings. Subsequently, in March 2022, we were informed by the U.S. Food and Drug Administration that the CYAD-101-002 |
• | Research continues in multiple discovery programs focused on the co-expression of Interleukin-18 (IL-18) in conjunction with our short hairpin RNA (shRNA) technology platform, also known as our shARC (shRNA Armored CAR) franchise. |
• | In April, we decided to stop the development of CYAD-203, an allogeneic shRNA-based, IL-18-armored back-up allogeneic NKG2D receptor CAR T candidates currently in discovery stage that leverage our shARC platform. |
• | Report additional data for the Phase 1 IMMUNICY-1 trial of CYAD-211 for the treatment of r/r MM, which are expected during second half of 2022. |
Selected key financial figures (€ millions) |
Half Year 30 June 2022 |
Half Year 30 June 2021 |
Full Year 31 December 2021 | |||
Revenue |
— |
— |
— | |||
Research and development expenses |
(10.5) |
(10.0) |
(20.8) | |||
General and administrative expenses |
(6.2) |
(4.8) |
(9.9) | |||
Change in fair value of contingent consideration |
1.1 |
(2.0) |
0.8 | |||
Other income/(expenses) |
1.6 |
1.8 |
3.4 | |||
Operating loss 1 |
(14.1) |
(14.9) |
(26.4) | |||
Loss for the period/year |
(14.1) |
(14.9) |
(26.5) | |||
Net cash used in operations |
(16.3) |
(12.2) |
(26.6) | |||
Cash and cash equivalents |
14.4 |
12.0 |
30.0 |
1 |
The operating loss arises from the Company’s loss for the period before deduction of financial income, financial expenses and income taxes. The purpose of this measure by Management is to identify the Company’s results in connection with its operating activities. |
• | The increase of employee expenses mainly related to the full expense impact of the employees recruited during 2021 to support the Group’s preclinical and clinical programs, employee turnover and management changes. |
• | The increase of IP filing and maintenance fees to strengthen the IP prosecution, partly compensated by; |
• | The decrease of expenses on clinical activities mainly due to the Phase 1b CYAD-101-002 (KEYNOTE-B79) trial which was on clinical hold during the second quarter of 2022. |
• | The updated assumptions on projected revenue associated to the Group’s allogeneic CAR T program CYAD-101 for the treatment of mCRC for which the timing of the potential commercialization of the Group’s CYAD-101 program has been delayed by one year. Additionally, the addressable patient population has been reduced based on recent safety findings for the candidate from the CYAD-101-002 |
• | The update in discount rate (Weighted Average Cost of Capital, or WACC) used for fair value measurement purposes at June 30, 2022, which led to an increase of the WACC; and |
• | The revaluation of the U.S. dollar against the Euro. |
• | The diversion of healthcare resources away from the conduct of clinical trial matters to focus on pandemic concerns, including the attention of physicians serving as the Company’s clinical trial investigators, hospitals serving as the clinical trial sites and hospital staff supporting the conduct of the clinical trials; |
• | Some patients who would otherwise be candidates for enrollment in the Company’s clinical trials are at increased risk of severe effects of the coronavirus, which may lead to the death of some patients and render others too ill to participate, limiting the available pool of participants for the trials; |
• | The fact that there can be no guarantee that any proposed changes to the Company’s protocols, if necessary, would be acceptable to regulators; |
• | Limitations on travel that interrupt key trial activities, such as clinical trial site initiations and monitoring; and |
• | Interruption in global shipping affecting the transport of clinical trial materials being used in the Company’s trials. |
1.2 |
Risks and uncertainties |
• | The Company may need substantial additional funding, which may not be available on acceptable terms when needed, if at all. |
• | The Company has substantial financial commitments resulting from material agreements (with Celdara Medical, The Trustees of Dartmouth College, Horizon Discovery), for which the Company will need substantial additional funding. |
• | The Company has incurred net losses in each period since its inception and anticipate that it will continue to incur net losses in the future. |
• | The Company’s drug product candidates are new approaches to cancer treatment that present significant challenges. |
• | The Company’s drug product candidates are biologics, which are complex to manufacture, and the Company may encounter difficulties in production, particularly with respect to process development or scaling-out of its manufacturing capabilities. If the Company or any of its third-party manufacturers encounters such difficulties, its ability to provide supply of its drug product candidates for clinical trials or its products for patients, if approved, could be delayed or stopped, or the Company may be unable to maintain a commercially viable cost structure. |
• | The future commercial success of the Company’s product candidates will depend on the degree of market acceptance of its products among physicians, patients, healthcare payers and the medical community. |
• | The Company may face significant competition and technological change which could limit or eliminate the market opportunity for its product candidates. |
• | The Company may encounter substantial delays in its clinical trials or may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities. |
• | The Company may be adversely affected by natural disasters and/or global health pandemics (such as COVID-19), and its business, financial conditions and results of operations could be adversely affected. |
• | In previous clinical trials involving T cell-based immunotherapies, some patients experienced serious adverse events. The Company’s drug product candidates may demonstrate a similar effect or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences. |
• | The Company’s trials are ongoing and not complete. Initial success in its ongoing clinical trials may not be indicative of results obtained when these trials are completed. Furthermore, success in early clinical trials may not be indicative of results obtained in later trials. |
• | The Company is heavily dependent on the regulatory approval of CYAD-02, CYAD-101 and CYAD-211 in the United States and Europe, and subsequent commercial success of those product candidates, both of which may never occur. |
• | Nearly all aspects of the Company’s activities are subject to substantial regulation. No assurance can be given that any of the Company’s product candidates will fulfil regulatory compliance. Failure to comply with such regulations could result in delays, suspension, refusals, fines and withdrawal of approvals. |
• | The Company could be unsuccessful in obtaining, maintaining or protecting its intellectual property rights for one or more of its drug product candidates. |
• | The Company’s patents and other intellectual property rights portfolio is relatively young and may not adequately protect its research programs and product candidates, which may impede the Company’s ability to compete effectively. |
• | The Company depends on intellectual property licensed from third parties and termination of any of these licenses could result in the loss of significant rights, which would harm its business. |
• | The Company may infringe on the patents or intellectual property rights of others and may face patent litigation, which may be costly and time consuming. |
• | The Company has not yet finalized its clinical development program for its product candidates. The FDA and comparable foreign regulators may not agree with its proposed protocols for these clinical trials, or may withdraw approvals, which could result in delays or cancellation of the programs. |
• | Cell-based therapies rely on the availability of specialty raw materials, which may not be available to the Company on acceptable terms or at all. |
• | The Company relies on third parties to conduct, supervise and monitor its clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, the Company may not be able to obtain regulatory approval for or commercialize its drug product candidates and its business could be substantially harmed. |
• | The Company relies and will continue to rely on collaborative partners regarding the development of its research programs and product candidates. |
• | The general economic impacts of the conflict in Ukraine are unpredictable and could lead to market disruptions, including significant volatility in commodity prices, credit and capital markets. |
(€‘000) | June 30, |
December 31, |
||||||||||
Notes |
2022 |
2021 |
||||||||||
NON-CURRENT ASSETS |
43 760 |
45 651 |
||||||||||
Goodwill and Intangible assets |
2.5.8 | 36 589 | 36 168 | |||||||||
Property, Plant and Equipment |
2 855 | 3 248 | ||||||||||
Non-current Trade and Other receivables |
2.5.9 | — | 2 209 | |||||||||
Non-current Grant receivables |
2.5.9 | 4 094 | 3 764 | |||||||||
Other non-current assets |
2.5.9 | 222 | 262 | |||||||||
CURRENT ASSETS |
19 380 |
34 292 |
||||||||||
Trade and Other Receivables |
2.5.10 | 757 | 668 | |||||||||
Current Grant receivables |
2.5.10 | 2 814 | 1 395 | |||||||||
Other current assets |
2.5.10 | 1 424 | 2 211 | |||||||||
Short-term investments |
2.5.11 | — | — | |||||||||
Cash and cash equivalents |
2.5.11 | 14 385 | 30 018 | |||||||||
|
|
|
|
|||||||||
TOTAL ASSETS |
63 140 |
79 943 |
||||||||||
|
|
|
|
|||||||||
EQUITY |
2.3 |
30 650 |
43 639 |
|||||||||
Share Capital |
2.5.12 | 78 585 | 78 585 | |||||||||
Share premium |
2.5.12 | 6 317 | 6 317 | |||||||||
Other reserves |
2.5.12 | 34 239 | 33 172 | |||||||||
Capital reduction reserve |
2.5.12 | 234 562 | 234 562 | |||||||||
Accumulated deficit |
2.5.12 | (323 053 | ) | (308 997 | ) | |||||||
NON-CURRENT LIABILITIES |
21 134 |
22 477 |
||||||||||
Bank loans |
— | — | ||||||||||
Lease liabilities |
2.5.17 | 1 381 | 1 730 | |||||||||
Recoverable Cash advances (RCAs) |
2.5.13 | 5 971 | 5 851 | |||||||||
Contingent consideration payable and other financial liabilities |
2.5.16 | 13 551 | 14 679 | |||||||||
Post-employment benefits |
53 | 53 | ||||||||||
Other non-current liabilities |
2.5.14 | 178 | 164 | |||||||||
CURRENT LIABILITIES |
11 356 |
13 827 |
||||||||||
Bank loans |
— | — | ||||||||||
Lease liabilities |
2.5.17 | 783 | 902 | |||||||||
Recoverable Cash advances (RCAs) |
2.5.13 | 669 | 362 | |||||||||
Trade payables |
2.5.15 | 6 008 | 6 611 | |||||||||
Other current liabilities |
2.5.15 | 3 896 | 5 952 | |||||||||
|
|
|
|
|||||||||
TOTAL EQUITY AND LIABILITIES |
63 140 |
79 943 |
||||||||||
|
|
|
|
(€‘000) | For the Six-month period ended June 30, |
|||||||||||
Notes |
2022 |
2021 |
||||||||||
Revenue |
2.5.6 |
— |
— |
|||||||||
Cost of sales |
— | — | ||||||||||
Gross profit |
2.5.6 |
— |
— |
|||||||||
Research and Development expenses |
(10 527 | ) | (9 956 | ) | ||||||||
General & Administrative expenses |
(6 245 | ) | (4 785 | ) | ||||||||
Change in fair value of contingent consideration |
1 128 | (1 961 | ) | |||||||||
Other income |
1 781 | 1 987 | ||||||||||
Other expenses |
(214 | ) | (162 | ) | ||||||||
Operating Loss 2 |
2.5.6 |
(14 077 |
) |
(14 877 |
) | |||||||
Financial income |
148 | 166 | ||||||||||
Financial expenses |
(127 | ) | (143 | ) | ||||||||
Loss before taxes |
2.5.6 |
(14 056 |
) |
(14 854 |
) | |||||||
Income taxes |
— | — | ||||||||||
Loss for the period |
2.5.6 |
(14 056 |
) |
(14 854 |
) | |||||||
Basic and diluted loss per share (in €) |
(0.62 | ) | (1.02 | ) | ||||||||
Other comprehensive income/(loss) |
||||||||||||
Items that will not be reclassified to profit and loss |
— |
— |
||||||||||
Remeasurements of post-employment benefit obligations, net of tax |
— | — | ||||||||||
Items that may be subsequently reclassified to profit or loss |
(9 |
) |
14 |
|||||||||
Currency translation differences |
(9 | ) | 14 | |||||||||
Other comprehensive income / (loss) for the period, net of tax |
(9 | ) | 14 | |||||||||
Total comprehensive loss for the period |
(14 065 |
) |
(14 840 |
) | ||||||||
Total comprehensive loss for the period attributable to Equity Holders |
(14 065 |
) |
(14 840 |
) | ||||||||
2 |
The operating loss arises from the Company’s loss for the period before deduction of financial income, Financial expenses and Income taxes. The purpose of this measure by Management is to identify the Company’s results in connection with its operating activities. |
(€‘000) | Share capital (non-distributable) |
Share premium (non-distributable) |
Other reserves 3 (distributable²) |
Capital reduction reserve (distributable²) |
Accumulated deficit (distributable²) |
Total Equity |
||||||||||||||||||
Balance as of January 1, 2021 (as adjusted) 1 |
48 513 |
43 349 |
30 958 |
191 213 |
(283 039 |
) |
30 994 |
|||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Capital increase |
5 400 | 2 660 | — | — | — | 8 060 | ||||||||||||||||||
Transaction costs associated with capital increases |
— | (443 | ) | — | — | — | (443 | ) | ||||||||||||||||
Reduction of share premium by absorption of losses |
— | (43 349 | ) | — | 43 349 | — | — | |||||||||||||||||
Share-based payments |
— | — | 1 090 | — | — | 1 090 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total transactions with owners, recognized directly in equity |
5 400 |
(41 132 |
) |
1 090 |
43 349 |
— |
8 707 |
|||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Loss for the period |
— | — | — | — | (14 854 | ) | (14 854 | ) | ||||||||||||||||
Currency Translation differences |
— | — | 14 | — | — | 14 | ||||||||||||||||||
Remeasurements of defined benefit obligation |
— | — | — | — | — | — | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total comprehensive loss for the period |
— |
— |
14 |
— |
(14 854 |
) |
(14 840 |
) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance as of June 30, 2021 (as adjusted) 1 |
53 913 |
2 217 |
32 062 |
234 562 |
(297 893 |
) |
24 861 |
|||||||||||||||||
Balance as of July 1, 2021 (as adjusted) 1 |
53 913 |
2 217 |
32 062 |
234 562 |
(297 893 |
) |
24 861 |
|||||||||||||||||
Capital increase |
24 672 | 6 240 | — | — | — | 30 912 | ||||||||||||||||||
Transaction costs associated with capital increases |
— | (2 140 | ) | — | — | — | (2 140 | ) | ||||||||||||||||
Share-based payments |
— | — | 1 082 | — | — | 1 082 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total transactions with owners, recognized directly in equity |
24 672 |
4 100 |
1 082 |
— |
— |
29 854 |
||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Loss for the period |
— | — | — | — | (11 658 | ) | (11 658 | ) | ||||||||||||||||
Currency Translation differences |
— | — | 28 | — | — | 28 | ||||||||||||||||||
Remeasurements of defined benefit obligation |
— | — | — | — | 554 | 554 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total comprehensive loss for the period |
— |
— |
28 |
— |
(11 104 |
) |
(11 076 |
) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance as of December 31, 2021 |
78 585 |
6 317 |
33 172 |
234 562 |
(308 997 |
) |
43 639 |
|||||||||||||||||
Balance as of January 1, 2022 |
78 585 |
6 317 |
33 172 |
234 562 |
(308 997 |
) |
43 639 |
|||||||||||||||||
Capital increase |
— | — | — | — | — | — | ||||||||||||||||||
Transaction costs associated with capital increases |
— | — | — | — | — | — | ||||||||||||||||||
Share-based payments |
— | — | 1 076 | — | — | 1 076 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total transactions with owners, recognized directly in equity |
— |
— |
1 076 |
— |
— |
1 076 |
||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Loss for the period |
— | — | — | — | (14 056 | ) | (14 056 | ) | ||||||||||||||||
Currency Translation differences |
— | — | (9 | ) | — | — | (9 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Total comprehensive loss for the period |
— |
— |
(9 |
) |
— |
(14 056 |
) |
(14 065 |
) | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance as of June 30, 2022 |
78 585 |
6 317 |
34 239 |
234 562 |
(323 053 |
) |
30 650 |
|||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
For information on voluntary change in accounting policy, see note 5.2.16 of the 2021 Annual Report. |
(2) |
Pursuant to Belgian law (“CCA”), the calculation of amounts available for distribution to shareholders, as dividends or otherwise, must be determined on the basis of the Company’s standalone non-consolidated statutory financial statements of Celyad Oncology SA prepared under Belgian GAAP, and not on the basis of IFRS consolidated financial statements. For more information, see note 2.5.12. |
(3) |
Other reserves include Share-base payment reserve, Other equity reserve from conversion of convertible loan in 2013 and Currency Translation Difference. |
(€‘000) | For the Six-month period ended June 30, |
|||||||||||
Notes |
2022 |
2021 |
||||||||||
Cash Flow from operating activities |
||||||||||||
Loss for the period |
2.2 | (14 056 | ) | (14 854 | ) | |||||||
Non-cash adjustments |
||||||||||||
Goodwill and Intangibles assets - Amortization and impairment |
455 | 106 | ||||||||||
Property, plant & equipment - Depreciation |
516 | 735 | ||||||||||
Provision for onerous contract |
59 | — | ||||||||||
Change in fair value of contingent consideration payable and other financial liabilities |
2.5.6 | (1 128 | ) | 1 961 | ||||||||
Remeasurement of Recoverable Cash Advances (RCAs) |
2.5.6 | 66 | 129 | |||||||||
Grant income (RCAs and others) |
2.5.6 | (1 449 | ) | (1 604 | ) | |||||||
Share-based payment expense |
1 076 | 1 090 | ||||||||||
Post-employment benefits |
— | — | ||||||||||
Change in working capital |
||||||||||||
Trade receivables, other (non-)current receivables |
514 | (738 | ) | |||||||||
Trade payables, other (non-)current liabilities |
(2 361 | ) | 990 | |||||||||
Net cash used in operations |
(16 308 |
) |
(12 185 |
) | ||||||||
Cash Flow from investing activities |
||||||||||||
Acquisition of Property, Plant & Equipment |
(106 | ) | (160 | ) | ||||||||
Acquisitions of Intangible assets |
— | (62 | ) | |||||||||
Proceeds from net investment in lease |
156 | 128 | ||||||||||
Proceeds from short-term investments |
1 090 | — | ||||||||||
Net cash from/(used in) investing activities |
1 140 |
(94 |
) | |||||||||
Cash Flow from financing activities |
||||||||||||
Repayments of bank borrowings |
— | (37 | ) | |||||||||
Repayments of leases |
(494 | ) | (581 | ) | ||||||||
Net proceeds from issuance of shares and exercise of warrants |
(125 | ) | 7 617 | |||||||||
Proceeds from RCAs & other grants |
2.5.7 | 174 | 333 | |||||||||
Repayment of RCAs & other grants |
— | (280 | ) | |||||||||
Net cash from/(used in) financing activities |
(445 |
) |
7 052 |
|||||||||
Net cash and cash equivalents at beginning of the period |
30 018 |
17 234 |
||||||||||
Change in Cash and cash equivalents |
2.5.7 | (15 613 | ) | (5 227 | ) | |||||||
Effects of exchange rate changes on cash and cash equivalents |
(20 | ) | 10 | |||||||||
Net cash and cash equivalents at the end of the period |
14 385 |
12 017 |
||||||||||
• | the immuno-oncology segment regrouping all assets developed based on the CAR T cell platform, and. |
• |
the cardiology segment, regrouping the Cardiopoiesis platform, C-Cath ez . |
For the Six-month period ended June 30, 2021 |
||||||||||||||||
€‘000 | Cardiology | Immuno-oncology |
Corporate | Group Total |
||||||||||||
Revenue recognized at a point in time |
— | — | — | — | ||||||||||||
Revenue recognized over time |
— | — | — | — | ||||||||||||
Total Revenue |
— |
— |
— |
— |
||||||||||||
Cost of Sales |
— | — | — | — | ||||||||||||
Gross Profit |
— |
— |
— |
— |
||||||||||||
Research & Development expenses |
(57 | ) | (9 899 | ) | — | (9 956 | ) | |||||||||
General & Administrative expenses |
— | — | (4 785 | ) | (4 785 | ) | ||||||||||
Change in fair value of contingent consideration |
— | (1 961 | ) | — | (1 961 | ) | ||||||||||
Net Other income/(loss) |
(54 | ) | 1 670 | 209 | 1 825 | |||||||||||
Operating Profit/(Loss) |
(111 |
) |
(10 190 |
) |
(4 576 |
) |
(14 877 |
) | ||||||||
Net financial income/(loss) |
149 | (87 | ) | (39 | ) | 23 | ||||||||||
Profit/(Loss) before taxes |
38 |
(10 277 |
) |
(4 615 |
) |
(14 854 |
) | |||||||||
Income Taxes |
— | — | — | — | ||||||||||||
Profit/(Loss) for the six-month period ended June 30, 2021 |
38 |
(10 277 |
) |
(4 615 |
) |
(14 854 |
) |
For the Six-month period ended June 30, 2022 |
||||||||||||||||
(€‘000) |
Cardiology |
Immuno-oncology |
Corporate |
Group Total |
||||||||||||
Revenue recognized at a point in time |
— | — | — | — | ||||||||||||
Revenue recognized over time |
— | — | — | — | ||||||||||||
Total Revenue |
— |
— |
— |
— |
||||||||||||
Cost of Sales |
— | — | — | — | ||||||||||||
Gross Profit |
— |
— |
— |
— |
||||||||||||
Research & Development expenses |
(268 | ) | (10 259 | ) | — | (10 527 | ) | |||||||||
General & Administrative expenses |
— | — | (6 245 | ) | (6 245 | ) | ||||||||||
Change in fair value of contingent consideration |
— | 1 128 | — | 1 128 | ||||||||||||
Net Other income/(loss) |
(74 | ) | 1 641 | — | 1 567 | |||||||||||
Operating Profit/(Loss) |
(342 |
) |
(7 490 |
) |
(6 245 |
) |
(14 077 |
) | ||||||||
Net financial income/(loss) |
(19 | ) | (68 | ) | 108 | 21 | ||||||||||
Profit/(Loss) before taxes |
(361 |
) |
(7 558 |
) |
(6 137 |
) |
(14 056 |
) | ||||||||
Income Taxes |
— | — | — | — | ||||||||||||
Profit/(Loss) for the six-month period ended June 30, 2022 |
(361 |
) |
(7 558 |
) |
(6 137 |
) |
(14 056 |
) |
For the Six-month period ended June 30, |
||||||||
(€‘000) | 2022 |
2021 |
||||||
Out-licensing revenue |
— | — | ||||||
Other revenue |
— | — | ||||||
|
|
|
|
|||||
Total |
— | — | ||||||
|
|
|
|
For the Six-month period ended June 30, |
||||||||
(€‘000) | 2022 |
2021 |
||||||
Employee expenses |
5 432 | 4 530 | ||||||
Clinical study costs |
1 465 | 2 205 | ||||||
Preclinical study costs |
1 034 | 944 | ||||||
Depreciation |
721 | 708 | ||||||
Process development and scale-up |
459 | 407 | ||||||
IP filing and maintenance fees |
458 | 84 | ||||||
Rent and utilities |
323 | 337 | ||||||
Share-based payments |
212 | 331 | ||||||
Consulting fees |
126 | 152 | ||||||
Travel & Living |
76 | 17 | ||||||
Others |
221 | 241 | ||||||
|
|
|
|
|||||
Total R&D expenses |
10 527 |
9 956 |
||||||
|
|
|
|
• |
The increase of employee expenses mainly related to the full expense impact of the employees recruited during 2021 to support the Group’s preclinical and clinical programs, employee turnover and management changes; |
• |
The increase of IP filing and maintenance fees to strengthen the IP prosecution, partly compensated by; |
• |
The decrease of on clinical activities mainly due to the Phase 1b CYAD-101-002 (KEYNOTE-B79) trial which was on clinical hold during the second quarter of 2022. |
For the Six-month period ended June 30, |
||||||||
(€‘000) | 2022 |
2021 |
||||||
Employee expenses |
2 589 | 1 789 | ||||||
Insurances |
1 215 | 730 | ||||||
Consulting fees |
1 138 | 1 030 | ||||||
Share-based payments |
864 | 759 | ||||||
Communication & Marketing |
190 | 236 | ||||||
Depreciation |
102 | 133 | ||||||
Travel & Living |
57 | 12 | ||||||
Rent |
32 | 15 | ||||||
Other |
58 | 81 | ||||||
|
|
|
|
|||||
Total General and administrative expenses |
6 245 |
4 785 |
||||||
|
|
|
|
For the Six-month period ended June 30, |
||||||||
(€‘000) | 2022 |
2021 |
||||||
Change in fair value of contingent consideration |
1 128 | (1 961 | ) | |||||
|
|
|
|
|||||
Total Change in fair value of contingent consideration |
1 128 |
(1 961 |
) | |||||
|
|
|
|
• |
The updated assumptions on projected revenue associated to the Group’s allogeneic CAR T program CYAD-101 for the treatment of mCRC for which the timing of the potential commercialization of the Group’s CYAD-101 program has been delayed by one year. Additionally, the addressable patient population has been reduced based on recent safety findings for the candidate from the CYAD-101-002 |
• |
The update in discount rate (Weighted Average Cost of Capital, or WACC) used for fair value measurement purposes at June 30, 2022, which led to an increase of the WACC (see note 2.5.16.2); and |
• |
The revaluation of the U.S. dollar against the Euro. |
For the Six-month period ended June 30, |
||||||||
(€‘000) |
2022 |
2021 |
||||||
Grant income (RCAs) |
645 | 1 438 | ||||||
Grant income (Other) |
804 | 166 | ||||||
R&D tax credit |
329 | 339 | ||||||
Other |
3 | 44 | ||||||
|
|
|
|
|||||
Total Other Income |
1 781 |
1 987 |
||||||
|
|
|
|
• |
Grant income (RCAs): additional grant income has been recognized in 2022 on grants in the form of recoverable cash advances (RCAs) for contracts, mainly on conventions numbered 8212 (CYAD-101), 8436 (CYAD-211) and 1910028 (shARC franchise). According to IFRS standards, the Company has recognized grant income for the period amounting to €0.6 million and a liability component of €0.4 million is accounted for as a financial liability (see disclosure note 2.5.13). The decrease compared to June 30, 2021 is mainly associated with lower additional grant income recognized on conventions aligned with the decrease of clinical activities; |
• | Grant income (Others): additional grant income has been recognized in 2022 on grants received from the regional government for contract numbered 8516 (new engagers), not referring to RCAs and not subject to reimbursement. The increase compared to June 30, 2021 is mainly associated with additional grant income recognized on new convention signed during the last quarter of 2021 (contract numbered 8516 on new engagers) partly compensated by the decrease of grants received from the Federal Belgian Institute for Health Insurance (Inami) in the first half of 2021 fo r €0.2 million and for which no revenue has been recognized during the first half of 2022; and |
• | With respect to R&D tax credit, the curr e nt year income (€0.3 million) is in line with previous year. |
For the Six-month period ended June 30, |
||||||||
(€‘000) | 2022 |
2021 |
||||||
Clinical Development milestone payment |
— | — | ||||||
Remeasurement of RCAs |
66 | 129 | ||||||
Other |
148 | 33 | ||||||
Total Other Expenses |
214 |
162 |
||||||
For the Six-month period ended June 30, |
||||||||
(€‘000) |
2022 |
2021 |
||||||
Loss of the year attributable to Equity Holders |
(14 056 | ) | (14 854 | ) | ||||
Weighted average number of shares outstanding |
22 593 956 | 14 587 330 | ||||||
Earnings per share (non-fully diluted) in € |
(0.62 |
) |
(1.02 |
) | ||||
Outstanding warrants |
2 269 448 | 1 899 090 | ||||||
2.5.7 |
Liquidity and capital resources |
For the Six-month period ended June 30, |
||||||||
(€‘000) | 2022 |
2021 |
||||||
Net cash used in operations |
(16 308 | ) | (12 185 | ) | ||||
Net cash (used in)/from investing activities |
1 140 | (94 | ) | |||||
Net cash (used in)/from financing activities |
(445 | ) | 7 052 | |||||
Effects of exchange rate changes |
(20 | ) | 10 | |||||
Change in Cash and cash equivalents |
(15 633 |
) |
(5 217 |
) | ||||
Change in Short-term investments |
— | — | ||||||
Net cash burned over the period 3 |
(15 633 |
) |
(5 217 |
) | ||||
2.5.8 |
Goodwill and Intangible assets |
As at June 30, |
As at December 31, |
|||||||
(€‘000) | 2022 |
2021 |
||||||
OnCyte IPRD |
33 678 | 33 678 | ||||||
C-Cathez development cost s |
441 | 474 | ||||||
Goodwill |
883 | 883 | ||||||
Patents & Licenses |
884 | 1 099 | ||||||
Other intangible assets |
703 | 34 | ||||||
Total Goodwill and Intangible assets |
36 589 |
36 168 |
||||||
3 |
‘Net cash burn’ is an alternative performance measure determined by the year-on-year |
As at June 30, |
As at December 31, |
|||||||
(€‘000) | 2022 |
2021 |
||||||
Non-current trade receivables Mesoblast license agreement |
— | 2 209 | ||||||
Total Non-current Trade and Other receivables |
— |
2 209 |
||||||
As at June 30, |
As at December 31, |
|||||||
(€‘000) | 2022 |
2021 |
||||||
R&D Tax credit receivable |
4 094 | 3 764 | ||||||
Total Non-current Grant recevables |
4 094 |
3 764 |
||||||
Deposits |
222 | 262 | ||||||
Total Other non-current assets |
222 |
262 |
||||||
4 |
The Probability of Success (PoS) associated to the product candidate CYAD-211 also used by management within impairment testing of Goodwill and OnCyte IPRD are the same as the PoS associated with the product candidate CYAD-02 used for the contingent consideration liability reassessment (see note 2.5.16.2). |
As at June 30, |
As at December 31, |
|||||||
(€‘000) | 2022 |
2021 |
||||||
Trade receivables |
466 | 203 | ||||||
Advance deposits |
210 | 246 | ||||||
Net Investment in Lease |
81 | 219 | ||||||
Total Trade and Other receivables |
757 |
668 |
||||||
Current Grant receivables (RCAs) |
1 736 | 1 121 | ||||||
Current Grant receivables (Others) |
1 078 | 274 | ||||||
Total Current Grant receivables |
2 814 |
1 395 |
||||||
Prepaid expenses |
1 069 | 1 688 | ||||||
VAT receivable |
316 | 483 | ||||||
Income and other tax receivables |
39 | 40 | ||||||
Total Other current assets |
1 424 |
2 211 |
||||||
Total Trade receivables, current grant receivables and other current assets |
4 995 |
4 274 |
||||||
(€‘000) | As at June 30, 2022 |
As at December 31, 2021 |
||||||
Short-term investments |
— | — | ||||||
Cash at bank and on hand |
14 385 | 30 018 | ||||||
Total Short-term investments and Cash and cash equivalents |
14 385 |
30 018 |
||||||
(€‘000) | As at June 30, 2022 |
As at December 31, 2021 |
||||||
Capital |
78 585 | 78 585 | ||||||
Share premium |
6 317 | 6 317 | ||||||
Other reserves |
34 239 |
33 172 | ||||||
Capital reduction reserve |
234 562 |
234 562 | ||||||
Accumulated deficit |
(323 053 | ) | (308 997 | ) | ||||
Total number of issued and outstanding shares |
22 593 956 |
22 593 956 |
||||||
(€‘000) | As at June 30, 2022 |
As at December 31, 2021 |
||||||
Non-Current portion |
5 971 | 5 851 | ||||||
Current portion |
669 | 362 | ||||||
Total Recoverable Cash Advances |
6 640 |
6 213 |
||||||
(€‘000) | As at June 30, 2022 |
As at December 31, 2021 |
||||||
Other non-current liabilities |
178 | 164 | ||||||
Total Other non-current liabilities |
178 |
164 |
||||||
(€‘000) | As at June 30, 2022 |
As at December 31, 2021 |
||||||
Total Trade payables |
6 008 |
6 611 |
||||||
Other current liabilities |
||||||||
Social security |
262 | 332 | ||||||
Payroll accruals |
2 107 | 1 798 | ||||||
Onerous contracts - current liabilities |
256 | 388 | ||||||
Other current grant liabilities |
879 | 1 096 | ||||||
Others |
392 | 2 338 | ||||||
Total Other current liabilities |
3 896 |
5 952 |
||||||
Total Trade payables and other current liabilities |
9 904 |
12 563 |
||||||
(€‘000) |
As at June 30, 2022 |
As at December 31, 2021 |
||||||
Financial Assets (‘Amortized cost’ category) within: |
||||||||
Non-current Trade receivables |
— | 2 209 | ||||||
Other non-current assets |
222 | 262 | ||||||
Trade receivables and other current assets |
757 | 668 | ||||||
Short-term investments |
— | — | ||||||
Cash and cash equivalents |
14 385 | 30 018 | ||||||
Total |
15 364 |
33 157 |
||||||
(€‘000) |
As at June 30, 2022 |
As at December 31, 2021 |
||||||
Financial Liabilities (‘Amortized cost’ category) within: |
||||||||
Bank loans |
— | — | ||||||
Lease liabilities |
2 164 | 2 632 | ||||||
RCAs liability |
6 640 | 6 213 | ||||||
Trade payables |
6 008 | 6 611 | ||||||
Total |
14 812 |
15 456 |
||||||
(€‘000) |
Level I |
Level II |
Level III |
Total |
||||||||||||
Liabilities |
— |