H1 financial results

• The Company continues to bolster its intellectual property estate and to pursue options to monetize it
• The Company’s two main research and development platforms have delivered proof-of-concept and are ready to be incorporated into clinical candidates and/or to be further explored and exploited via potential partnerships
• The Company actively participated at several key international scientific conferences and published in well-renowned peer-reviewed journals which have raised the interest for the Company’s technologies and developments
• Operational expenses according to Budget allowing cash runway until third quarter 2025

Mont-Saint-Guibert, Belgium; September 13, 2024, 7:00 am CET; regulated information – Celyad Oncology (Euronext: CYAD) (the “Company”), today announces its financial results for the first half year 2024 ended June 30, 2024, and provides a business update.

Michel Lussier, interim Chief Executive Officer of Celyad Oncology, commented: “Celyad Oncology continues to make remarkable progress in developing cutting-edge technologies for chimeric antigen receptor (CAR) T-cell therapy. Our groundbreaking multiplex platform is revolutionizing the potential of CAR T-cells, while our pioneering NKG2D-based multispecific CAR T-cell platform is further paving the way to conquer current limitations of this transformative class of immunotherapy”

H1-2024 Business highlights

• The Company is pursuing a strategy of continued research and development, with a particular focus on intellectual property (IP). 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 out-licensing deals;
• With its research focus, the Company has made concrete progress by providing proof-of-concept of the multiplex short hairpin RNAs (shRNAs) non-gene edited technology platform and the multispecific NKG2D-based CAR T-cell platform, which provide unique options to tackle the major current limitations of CAR T-cell therapies. Options to further explore or validate these data through strategic partnerships, and/or to incorporate these technologies into clinical CAR-T candidates are actively pursued by the Company;
• The Company continues to share and discuss its latest advances at international scientific conferences throughout the first half of 2024 with updated results provided at the 27th ASGCT [1] Annual Meeting and the Recent insights into Immuno-Oncology VIB conference [2].
• The Company is also focusing on sharing data and views with the scientific community and has published a review highlighting the interest of non-gene editing technologies for allogeneic CAR T-cell therapies in Cells [3] and another review providing an overview of all engineering strategies to safely drive CAR T-cells into the future in Frontiers in Immunology [4], two well-renowned peer-reviewed scientific journals;
• 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.

H1-2024 operational highlights

• Multiplex shRNA non-gene edited technology – The Company developed a chimeric micro-RNA (miRNA) cluster to enable multiplexing of shRNAs, designed for easy, efficient, and tunable downregulation of up to four target genes simultaneously in CAR T-cells. 
  • Data successfully demonstrated the feasibility and effectiveness of the multiplex approach to improve allogeneic CAR T-cell viability by avoiding graft-versus-host disease (GvHD) via knocking down of CD3ζ, avoiding host-versus-graft (HvG) reaction and promoting cell persistence via knocking-down of β2M and CIITA, and avoiding CD95L-induced autophagy via knocking-down of CD95;
  • Another multiplex cassette focusing on the knock-down of co-inhibitory receptors (PD-1, LAG-3, TIM-3 and CD95) was also developed to decrease the expression of exhaustion markers at the surface of CAR T-cells.
• Multispecific NKG2D-based CAR T-cell platform – Different NKG2D-based multispecific CAR T-cells were developed to provide the proof-of-concept that NKG2D ligands (NKG2DL) are valuable targets in a multispecific CAR approach to counteract relapses due to antigen loss or antigen heterogeneity.
  • 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 and improve anti-tumor efficacy against prostate cancer were developed and demonstrated functionality in vitro against prostate cancer cell lines expressing or not the tumor-associated antigen PSMA;
  • In vivo proof-of-concept of the company’s CD19/NKG2DL tandem CAR T-cell candidate was also provided in a B-ALL relapse model, showing that this multi-specific CAR T-cell candidate has an enhanced anti-tumor efficacy against heterogeneous lymphoma tumors, or to counteract antigen loss, as compared to currently existing treatment options.

First Half 2024 financial review

As of June 30, 2024, the Company’s Treasury position amounts to €6.2 million.

After due consideration of detailed budgets and estimated cash flow forecasts for the years 2024 and 2025, the Company projects that its existing cash and cash equivalents will be sufficient to fund its estimated operating and capital expenditures into the third quarter of 2025.

Key financial figures for first half 2024, compared with the first half of 2023 and full year 2023, are summarized below:

Selected key financial figures (€ millions)	Half Year 30 June 2024	Half Year 30 June 2023	Full Year 31 December 2023
Revenue	–	–	0.1
Research and development expenses	(1.5)	(2.1)	(4.6)
General and administrative expenses	(1.7)	(3.7)	(6.0)
Change in fair value of contingent consideration	–	–	0
Impairment of Oncology intangible assets	–	–	0
Other income/(expenses)	0.2	2.1	2.1
Operating loss	(3.1)	(3.7)	(8.5)
Loss for the period/year	(3.0)	(3.7)	(8.5)
Net cash used in operations	(2.8)	(8.3)	(15.2)
Cash and cash equivalents	6.2	5.0	7.0

Research and Development (R&D) expenses were €1.5 million in June 2024 as compared to €2.1 million during the same period in 2023, a decrease of €0.6 million. The decrease in the Company’s R&D expenses is primarily driven by the Company’s strategic decision in 2022 and beginning of 2023 to discontinue clinical development and prioritization of most promising research programs.

General and Administrative (G&A) expenses were €1.7 million in June 2024 as compared to €3.7 million during the same period in 2023, a decrease of €2.0 million. This decrease is mainly related to the decrease in employee expenses related to headcount reduction and management changes to support the Company’s reorganization (notably resulting from Nasdaq delisting and SEC deregistration of the Company) and to a decrease in insurance costs and consulting fees.

As of June 30, 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. The Company’s other income is mainly associated with grants received and some insurance compensations.

Net loss for the first half of 2024, was €3.0 million, or € (0.07) per share, compared to a net loss of €3.7 million, or € (0.17) 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 partly compensated by lower amounts of grants revenues from public institutions.

Net cash used in operations was €2.8 million for the first half of 2024 compared to €8.3 million for the first half of 2023. The decrease of €5.5 million is primarily driven by the global decrease in preclinical and clinical activities, insurance costs and headcount.  In 2023 the deviation between Net cash used in operations and Loss of the period was mainly explained by the change in the working capital (Trade payables and other liabilities decrease). The decrease of these costs is in line with the Company’s decision to adopt and implement over the last few months of the year 2022 the new business strategy to focus on early-stage discovery research in areas of expertise where it can leverage the differentiated nature of its platforms.

Upcoming anticipated milestones

• More data and evidence in the context of the multispecific CAR and shRNA multiplex platforms, with the possibility of a clinical evaluation of assets and initiation of clinical trials either by the Company and/or through strategic partnerships afterwards;
• Celyad Oncology will attend and present updated data on its programs at the 9th CAR-TCR Summit in Boston, US (Sep. 17-20), the Advanced Therapies Europe in Estoril (Sep. 10-12) and present two posters at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Houston (Nov. 6-10);
• The Company anticipates the appointment of a new CEO in the second half of 2024.

Financial Calendar 2025

• April 2^nd  2025 : Full Year 2024 Financial Statements
• May 5^th 2025 : Annual shareholders meeting
• September 25^th 2025 : First Half 2025 Interim results

The financial calendar is communicated on an indicative basis and may be subject to change.

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[1] American Society of Gene & Cell Therapy Annual meeting, Baltimore, US (May 7-11, 2024)

[2] Recent insights into Immuno-Oncology VIB (Flemish Institute for Biotechnology) conference,  Antwerp (May 30-31, 2024)

[3] Cells 2024;13(2):146

[4] Front Immunol. 2024:15:1411393

• Georges Rawadi was appointed Chief Executive Officer as from April 27, 2023
• Celyad Oncology has received approximately EUR 9.8m in private placement commitments from historical shareholders
• Encouraging progress in multiplex shRNA platform development, which allows now targeting of up to four genes simultaneously, were presented at international meetings
• In vitro validation of NKG2D-based multi-specific CAR T-cell platform with a first candidate targeting both NKG2D ligands and CD19was also presented

Mont-Saint-Guibert, Belgium; September 4, 2023, 10:00 pm CET; regulated information – Celyad Oncology (Euronext: CYAD) (the “Company” or “Celyad Oncology”), today announces its financial results and recent business developments for the first half year, ended June 30, 2023.

“Celyad Oncology is now fully focused on maximizing the potential of its proprietary technology platforms and intellectual property, enabling the Company to be at the forefront of developing next-generation CAR T-cell therapies. We are eager to see the impact of our research efforts on the future of CAR T-cell treatments, with the goal to broaden the range of cancer indications and tackle the main limitations of current CAR T-cell therapies” commented Georges Rawadi, Celyad Oncology’s Chief Executive Officer.

First Half 2023 and recent corporate highlights:

• Georges Rawadi was appointed Chief Executive Officer of the Company as from April 27, 2023. Georges Rawadi is a seasoned executive with over 20 years of experience in pharma/biotech, as research director, business developer, CEO, and board member. He also has insightful knowledge of both the company and the CAR-T space as he spent four years at Celyad Oncology (2014-2018) as Vice-President Business Development & Intellectual Property (“BD & IP”). Georges Rawadi has a genuine passion for seeking and creating new business opportunities.
• On May 5th, 2023, the Company announced voluntary delisting of its American Depositary Shares representing ordinary shares (“ADSs”) from the Nasdaq Global Market. Delisting was effective as of July 20, 2023. The Company continues to be listed on Euronext Brussels and Euronext Paris.
• On August 24, 2023, the Company announced that it has obtained commitments from Fortress, Tolefi and other longstanding existing shareholders to subscribe to a capital increase of up to €9.8 million in 2 tranches:
  • A first tranche of 2.0 million was disbursed in the context of authorized capital as of September 4, 2023; and
  • A second tranche to be subscribed by Fortress is subject to the approval by the extraordinary shareholders’ meeting. Following this private placement, the Company believes that its existing cash and cash equivalents should be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements into the end of the fourth quarter of 2024.

First Half 2023 and recent operational highlights:

• Short hairpin ribonucleic acid (shRNA) non-gene edited technology – During this first half of 2023, we have collected and presented data validating our shRNA multiplexing approach:
  • We developed a micro-RNA (miRNA)-based multiplex shRNA platform designed for easy, efficient, and tunable downregulation of up to four target genes simultaneously; 
  • We showed that the downregulation of each target gene could be fine-tuned, from a moderate downregulation up to a functional knock-out, without the need of gene editing thereby avoiding associated potential safety issues;
  • The plug-and-play design of our platform is designed to allow swapping of each target sequence without affecting the performance of the technology and streamlining of the generation of engineered adoptive T-cell therapies;
  • To demonstrate the effectiveness of our approach, we have been able to simultaneous knock-down in CAR T-cells several genes involved in different cellular processes such as alloreactivity (CD3ζ), cell persistence (β2M, CIITA), T-cell exhaustion (PD-1, LAG-3), or ligand-induced apoptosis (CD95);
  • Data were presented at the World Oncology Cell Therapy Congress in Boston, US (April 25-26, 2023) and at the CAR-TCR Summit in Boston, US (August 29 – September 1).
• NKG2D-based CAR T-cells and multi-specific CAR T-cell platform – During this first half of 2023, we have published data validating our NKG2D-based CAR T-cell approach and presented data from our multi-specific CAR T-cell platform:
  • Results from 16 patients treated in the dose-escalation segment of the hematological arm of the Phase I THINK trial were published in The Lancet Haematology Journal (Lancet Haematol. 2023 Mar;10(3):e191-e202) and provided proof-of-concept for targeting NKG2D ligands (NKG2DL) with CAR T-cell therapy;
  • We have developed different CD19/NKG2DL multi-specific CAR T-cells, utilizing both tandem and dual NKG2D-based CARs that encompass the extracellular domain of the natural NKG2D receptor fused to an anti-CD19 scFv, or co-expressed with an anti-CD19 CAR, respectively;
  • The majority of our CD19/NKG2DL multi-specific CAR T-cell candidates were able to secrete cytokines, proliferate, and eliminate acute lymphoblastic leukemia tumor cells lacking the CD19 antigen in vitro. Interestingly, some of these multi-specific CAR T-cells displayed a better in vitro functionality against wild-type leukemia tumor cells expressing the CD19 antigen as compared to CD19-specific single targeting CAR T-cells, highlighting the potential of our approach against both CD19 positive and CD19 negative cancer cells;
  • First in vivo data suggest that our CD19/NKG2DL multi-specific CAR T-cell candidates have an enhanced anti-tumor efficacy against heterogeneous lymphoma tumors as compared to currently existing treatment options;
  • We are currently developing several NKG2D-based multi-specific CAR T-cells for the treatment of diverse solid cancers where there is a high heterogeneity in antigen expression;
  • Data were presented at the Immuno-Oncology Summit Europe 2023 held in London, UK (June 20-22, 2023).

Upcoming anticipated milestones

• More data and evidence in the context of the multi-specific CAR platform and shRNA multiplexing approach in H2 2023, with the aim of a clinical evaluation of assets and initiation of clinical trials either by the Company and/or through strategic partnerships afterwards;
• Relocation, in H2 2023, into a new research facility which fits better  its current needs after the strategic shift. The Company will remain headquartered at the Axis Parc, Mont-Saint-Guibert, Belgium but with its new business location at Dumont 9.

Upcoming Conferences

• The Company will take part in the 4th International Conference on Lymphocyte Engineering (ICLE) in Munich (September 12-14) and the annual congress of the Society for Immunotherapy of Cancer (SITC) in San Diego (November 1-5), as well at several business conferences in the second half of 2023.

First Half 2023 Financial Results

Key financial figures for the first half of 2023, compared with the first half of 2022 and full year 2022, are summarized below:

The Company’s license and collaboration agreements generated no revenue in the first half of 2023 similar to the first half of 2022.

The Research and Development (R&D) expenses have decreased primarily due to the Company’s decision to discontinue some of preclinical programs and manufacturing and clinical study activities after the Company’s decision to adopt and implement a new business strategy. Furthermore, there has been a decrease of employee expenses and related travel costs which is mainly related to headcount reduction through 2022, to support the Group’s reorganization around preclinical and clinical programs, as well as a decrease of the expenses associated  with share-based payments (non-cash expenses) related to the warrant plan offered to the Company’s employees, managers and directors.

General and Administrative (G&A) expenses were €3.7 million in 2023 as compared to €6.2 million in 2022. This decrease is primarily related to lower insurances costs, the decrease of employee expenses due to headcount reduction and management changes through 2022 to support the Company’s reorganization and the decrease of the expenses associated with the share-based payments (non-cash expenses) related to the warrants plan offered to the Company’s employees, managers and directors.

As of June 30, 2023, there was no change in fair value of the contingent consideration and other financial liabilities as Management has determined that there have been no event (such as a firm sublicense or collaboration contract) that increases the probability of the projected future cash outflow due to Celdara Medical, LLC and Dartmouth College, indicating that the probability is remote, similar to December 31, 2022.

Regarding the other income/other expenses, the Company recorded €2.1 million in net other income for the first half of 2023 compared to a net other income of €1.6 million for the first half of 2022. The net other income for the first half of 2023 is primarily due to the gain on the sale of certain fixed assets to Cellistic for €1.1 million and grant income from the Walloon Region of €0.8 million.

Net loss was €3.7 million, or €(0.17) per share, for the first half of 2023 compared to a net loss of €14.1 million, or €(0.62) per share, for the same period of 2022.

Net cash used in operations, was €8.3 million for the first half of 2023 compared to €16.3 million for the first half of 2022. The decrease of €8.0 million is primarily driven by the sale of the manufacturing activities in 2022 combined with global decrease on preclinical and clinical activities, insurance costs, headcount, management changes costs and associated impact on the change in working capital.

As of June 30, 2023, the Company had cash and cash equivalents of €5.0 million. No capital increase has occurred in the first half of 2023.

As of June 30, 2023, the total number of basic shares outstanding were 22.6 million similar to December 31, 2022.

Conference Call and Webcast Details

A conference call will be held on Tuesday 5^th of September at 1:00 p.m. CET / 7:00 a.m. EDT discuss half year 2023 financial results and provide an update on the Company’s recent changes and upcoming milestones.

Participants may access the conference call by dialing +1-877-407-9716 or +1-201-493-6779 (United States, International), +32 (0) 800-73-904  (Belgium Fixed) or +32 (0) 800-73-566 (Belgium Mobile). Participants may ask for instant telephone access to the event via the “Call me” link or attend the conference live webcast.

Archived recording will be available in the “Events” section of the Celyad website after the event.

Financial Calendar 2023

November 9th, 2023

Third Quarter 2023 Business Update

The financial calendar is communicated on an indicative basis and may be subject to change.