- 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 , theU.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 5 th, at2:00 p.m. CEST /8:00 a.m. EDT
MONT-SAINT-GUIBERT,
"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
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 CD3ζ 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. InJuly 2022 , based on that complete response, we received notification that the FDA lifted the clinical hold on the CYAD-101-002 phase 1b trial
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
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 | Half Year | Full Year |
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 Group’s 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
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 Company’s NKG2D-based CAR T candidates as of
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
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
As of
Celyad Oncology First Half 2022 Conference Call Details
Date:
Time:
Dial-in: +1 201 493 6779 (International), + 1 877 407 9716 (
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,
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 Oncology’s ability to leverage its intellectual property to develop programs and seek potential partnership opportunities, the continued development of Celyad Oncology’s 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 Oncology’s pipeline, Celyad Oncology’s ability to effectively leverage its intellectual property portfolio, Celyad Oncology’s 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 Oncology’s ability to continue to access to the equity purchase agreement with
Investor and Media Contacts:
Communications & Investor Relations Director
Celyad Oncology
investors@celyad.com
Source:
Interim Consolidated Statement of Comprehensive Income (Unaudited)
For the Six-month period | For the Six-month period | |||
(€'000) | ended | ended | ||
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 | ) |
Interim Consolidated Statement of Financial Position (Unaudited)
(€’000) | ||||
2022 | 2021 | |||
NON-CURRENT ASSETS | 43 760 | 45 651 | ||
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 | ||
Source:
2022 GlobeNewswire, Inc., source