On April 2, 2025 Celyad Oncology (Euronext: CYAD) (the "Company"), reported its financial results for the fiscal year ended December 31, 2024, and provides a business update (Press release, Celyad, APR 2, 2025, View Source [SID1234651751]).
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Matt Kane, Chief Executive Officer of Celyad Oncology, commented: "2024 was an important and highly productive year for the Company as it emerged with a lean and efficient new structure. I am incredibly proud of the resilience and ingenuity demonstrated by the team throughout the year."
2024 business highlights
Monetization of its innovative approaches and technologies is a key objective. Celyad Oncology is progressing in this regard and is currently in discussion with potential partners for selected out-licensing of its technologies;
The Company continues to address current deficiencies in CAR-T approaches. It has published a review highlighting non-gene editing technologies for allogeneic CAR T-cell therapies in Cells[1] and a review providing an overview of engineering strategies to safely drive CAR T-cells into the future in Frontiers in Immunology [2];
In response to the request expressed by several companies and academic institutions engaged in gene and cell therapies for cardiac applications, the Company has re-initiated the manufacturing and commercialization of C-Cath, an intra-myocardial injection catheter developed and owned by the Company.
2024 operational highlights
Multiplex micro ribonucleic acid (miRNA)-based short hairpin RNA (shRNA) non-gene edited technology platform
Last year, the company introduced a chimeric micro-RNA (miRNA) cluster to enable multiplexing of shRNAs, and downregulation of up to four target genes simultaneously in CAR T-cells. In 2024, we further advanced this technology by expanding the platform to a 5-plex system. The novel chimeric cluster demonstrated high efficiency in knocking down five highly relevant genes in CAR T-cells simultaneously. Notably, our non-gene editing technology enabled independent modulation of each target gene to achieve the desired expression levels, thus fine-tuning the functional outcomes based on the specific biology of each target.
The feasibility and effectiveness of our multiplex approach to improve allogeneic CAR T-cell viability by avoiding graft-versus-host disease (GvHD) and host-versus-graft (HvG) reaction and promoting cell persistence was demonstrated. Additionally, the feasibility of this platform to withstand the immunosuppressive tumor microenvironment was further demonstrated. Lastly, the secretion of specific cytokines was modulated as a way to reduce the risk of CAR T-cell-related toxicity, and cytokine release syndrome, thus enhancing CAR T-cell safety.
Multispecific NKG2D-based CAR T-cell platform
PSMA/NKG2DL tandem CAR T-cells, that encompass the extracellular domain of the natural NKG2D receptor fused to an anti-PSMA CAR to overcome antigen heterogeneity were developed and demonstrated these CAR constructs are fully functional in vitro against prostate cancer cell lines that are positive or negative for the tumor-associated antigen PSMA. In vivo data confirmed the superiority of both PSMA/NKG2DL tandem CAR T-cells and NKG2DL single CAR T-cells over PSMA single CAR T-cells in a heterogeneous model of prostate cancer. These data provide a proof-of-concept that NKG2DL are valuable targets in a multispecific CAR approach to treat solid cancer indications;
In addition, the in vivo proof-of-concept of the previously developed CD19/NKG2DL tandem CAR T-cell candidate was provided in a B-ALL relapse model, showing that the Company’s multispecific CAR T-cell candidate has an enhanced anti-tumor efficacy in a lymphoma model of antigen-loss as compared to currently existing treatment options.
Full year 2024 financial review
As of December 31, 2024, the Company’s Treasury position amounts to €4.2 million.
The Company projects that its existing cash and cash equivalents should be sufficient to fund operating expenses and capital expenditure requirements into the third quarter of 2025. Hence, its existing cash and cash equivalents will not be sufficient to fund its estimated operating and capital expenditures over at least the next 12 months from the date that the financial statements are issued.
Refinancing discussions are ongoing.
Key financial figures for full-year 2024, compared with full-year 2023, are summarized below:
Selected key financial figures (€ millions) Full year 2024 Full year 2023
Revenue 0.2 0.1
Research and development expenses (3.2) (4.6)
General and administrative expenses (3.2) (6.0)
Other income/(expenses) 0.4 2.1
Operating loss (5.9) (8.5)
Loss for the period/year (5.8) (8.5)
Net cash used in operations (2.8) (15.2)
Treasury position (1) 4.2 7.0
(1) "Treasury position" is an alternative performance measure determined by adding Short-term investments and Cash and cash equivalents from the statement of financial position prepared in accordance with IFRS. Management’s purpose of this measure is to identify the level of cash available internally (excluding external sources of financing) within 12 months.
Research and Development (R&D) expenses were €3.2 million in 2024 as compared to €4.6 million in 2023, a year-over-year decrease of €1.4 million. The decrease in the Company’s R&D expenses is primarily driven by the Company’s continuous efforts to reduce significantly the preclinical and clinical costs following the change of business strategy by the Company end of 2022. Furthermore, employee expenses have decreased compared with the year 2023 as a consequence of the Company’s reorganization for the new business model in 2022 and 2023.
General and Administrative (G&A) expenses were €3.2 million in 2024 as compared to €6.0 million in 2023, a decrease of €2.8 million. This decrease is primarily related to the decrease of insurances costs, the decrease of employee and consulting fees expenses due to headcount reduction and management changes.
Until December 31, 2024, Management has determined that there has been no event (such as a firm sublicense or collaboration contract) that led to a change in fair value of the contingent consideration and other financial liabilities towards Dartmouth and Celdara.
The Company’s other income decrease of €1.9 million is mainly related to lower grants income from the Walloon Region of €0.8 million coupled to a one-time income of €1.1 million generated by the sale of certain fixed assets to Cellistic in 2023.
Net loss for the year ended December 31, 2024, was €5.8 million, or €0.14 per share, compared to a net loss of €8.5 million, or €0.34 per share, for the same period in 2023. As noted above, the decrease in net loss between periods was primarily due to the decrease of R&D and General and administrative expenses in 2024.
Net cash used in operations for the year ended December 31, 2024, which excludes non-cash effects, amounted to €5.7 million, which is far below the net cash used in operations of €15.2 million for the year ended December 31, 2023.
Alarm bell status
The net assets of the Company per 31 December 2024, on a BE-GAAP non-consolidated basis, having fallen below twenty-five percent of the Company’s capital, the board of directors will submit to the ordinary shareholders meeting on the 20th of May 2025 the proposal to continue the Company’s activities in accordance with article 7:228 of the Belgian Code for Companies and Associations. The board of directors will publish a special report in this respect, by the 18th of April 2024 together with the convening notice with proposed resolutions for the shareholders’ meeting.
Annual Report 2024
The Annual Report for the year ended December 31, 2024 will be published on April 04, 2025, and will be available on the Company’s website, www.celyad.com. The Company’s statutory auditor, BDO Réviseurs d’Entreprises SRL, has confirmed that the completed audit has not revealed any material misstatement in the consolidated financial statements. BDO also confirmed that the accounting data reported in the press release are consistent, in all material respects, with the consolidated financial statements from which it has been derived.
Financial Calendar 2025
May 20th, 2025 Annual shareholders meeting
September 25th, 2025 First Half 2025 Interim Results
The financial calendar is communicated on an indicative basis and may be subject to change.