Celyad Oncology

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 that on March 1, 2022, the Company was informed via e-mail communication from the U.S. Food and Drug Administration that the CYAD-101-002 (KEYNOTE-B79) Phase 1b trial has been placed on clinical hold due to insufficient information to assess risk to study subjects. As previously disclosed, on February 28, 2022, the Company announced that it was voluntarily pausing the CYAD-101-002 trial to investigate reports of two fatalities in the study.

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 it has taken the decision to voluntarily pause the CYAD-101-002 (KEYNOTE-B79) Phase 1b trial (NCT04991948).

The CYAD-101-002 trial is part of a collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, through a subsidiary. The trial is evaluating the Company’s TCR Inhibitory Molecule (TIM)-based allogeneic NKG2D CAR T cell investigational therapy CYAD-101 administered concurrently with FOLFOX chemotherapy, followed by MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with refractory metastatic colorectal cancer.

The Company has received reports of two fatalities that presented with similar pulmonary findings. With a clear focus on patient safety and an overriding sense of caution, the Company has decided to voluntarily pause dosing and enrollment of patients in the CYAD-101-002 trial in order to investigate these events. The Company is currently investigating these reports and evaluating any similar events in additional patients treated on study. The Company is informing regulatory agencies, which may require additional actions of the Company. The Company expects to provide additional updates on the trial in the near future.

“Our primary commitment is to maintain patient safety, which is why we decided to place the trial on hold while we investigate these events,” said Filippo Petti, Chief Executive Officer of Celyad Oncology. “We are working diligently to better understand these events. In twenty-five patients previously treated with CYAD-101 in the alloSHRINK Phase 1 trial, which evaluated the TIM-based investigational candidate for the treatment of advanced mCRC, no-dose limiting toxicities were reported. Lastly, we anticipate no impact on our shRNA-based candidates, including CYAD-211 currently under investigation for the treatment of multiple myeloma.”  

Mont-Saint-Guibert, Belgium – Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, today announced that the Company plans to participate virtually in the following conference in February 2022:

Virtual 11th Annual SVB Leerink Global Healthcare Conference 2022

Dates: Monday, February 14 to Friday, February 18, 2022

Presentation: February 18, 8 a.m. ET / 2 p.m. CET

Presenter: Filippo Petti, CEO

Webcast: A live and archived webcast of the presentation will be available in the Events section of the Celyad Oncology website.

• KEYNOTE-B79 and IMMUNICY-1 clinical trials evaluating the Company’s allogeneic CAR T candidates, CYAD-101 and CYAD-211 respectively, expected to generate key data throughout 2022
• Company’s proprietary non-gene edited shRNA technology clinically validated as a novel platform for the development of next-generation, allogeneic CAR Ts
• Preclinical shRNA-based allogeneic pipeline continues to progress with IL-18-armored CAR T candidate CYAD-203 as well as discovery programs focused on in-licensed T-cell engagers targeting TAG72 and GPC3
• Recent $32.5 million private placement with Fortress Investment Group affiliate to fund further research and development of Company’s current allogeneic CAR T pipeline

MONT-SAINT-GUIBERT, Belgium, January 10, 2022 – Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, today announced a 2021 year-end review and provided an outlook for 2022.

Filippo Petti, Chief Executive Officer of Celyad Oncology, said, “Our clinical development team has continued to deliver a steady stream of data across multiple programs throughout 2021 that advanced our position as a leader in the field of allogeneic CAR T cell therapies. Singlehandedly, the validation of our proprietary shRNA platform this past year represented an incredible achievement for the Company as we continued to strategically transform the organization to a fully allogeneic CAR T platform Company. The power and versatility of our shRNA platform, including the ability to multiplex and modulate the levels of gene expression, continues to support its strength, value, and potential differentiation within the allogenic cell therapy landscape. We believe our non-gene edited technologies are well-positioned to drive a major impact on the CAR T industry as the approach that does not have the risks associated with gene-editing technologies, including the potential for translocation adverse events.”

“Our leading clinical CAR T assets, novel shRNA platform and foundational intellectual property within the allogeneic landscape has attracted widespread industry attention including most recently from Fortress Investment Group, which invested $32.5 million into the Company. We believe our cutting-edge research in the allogeneic CAR T field supported by clinical data presented at multiple medical conferences over the past year and combined with these broader resources place us on an accelerated path towards developing the therapeutic benefit of our extensive set of technologies. This is an exciting time at Celyad Oncology and we look forward to building upon our recent accomplishments throughout 2022 and beyond,” concluded Mr. Petti.

2021 Business Highlights

• Dosed first patient in KEYNOTE-B79 Phase 1b trial (NCT04991948), which will evaluate the TCR Inhibitory Molecule (TIM)-based allogeneic NKG2D CAR T cell investigational therapy CYAD-101 with MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with refractory metastatic colorectal cancer (mCRC) with microsatellite stable (MSS) / mismatch-repair proficient disease
• Data from the dose-escalation segment of the IMMUNICY-1 Phase 1 trial (NCT04613557) evaluating the allogeneic shRNA-based anti-BCMA CAR T candidate CYAD-211 in patients with relapsed or refractory multiple myeloma (r/r MM) showed evidence of clinical activity with a good tolerability profile including no evidence of Graft versus Host Disease (GvHD). In addition, all patients in trial had detectable CYAD-211 cells in the peripheral blood
• Research & Development Day in July showcased the Company’s current pipeline of allogeneic CAR T programs and shRNA-based preclinical concepts while also introducing CYAD-203 – an allogeneic shRNA-based interleukin-18 (IL-18)-armored NKG2D CAR T candidate
• Presented clinical results from the CYCLE-1 Phase 1 trial (NCT04167696) evaluating the next-generation, autologous NKG2D receptor CAR T candidate CYAD-02. Data from the study showed that a single shRNA can target two independent genes (MICA/MICB) to enhance the phenotype of the CAR T cells – a differentiated approach among currently available gene-expression control technologies
• Bolstered balance sheet with $32.5 million private placement with an affiliate of Fortress Investment Group. The Company believes its existing cash and cash equivalents combined with access to the equity purchase agreement established with Lincoln Park Capital Fund, LLC should be sufficient to fund operating expenses and capital expenditure requirements into the first half of 2023

Program Update and Anticipated Milestones for 2022

• Following the dose-escalation segment of the IMMUNICY-1 Phase 1 trial for CYAD-211, the next segment of the study will evaluate enhanced lymphodepleting regimens with the aim to improve cell persistence and potentially maximize the clinical benefit of the anti-BCMA CAR T candidate. The IMMUNICY-1 protocol also allows for CYAD-211 redosing in certain patients. Enrollment in the cohorts evaluating enhanced lymphodepletion is ongoing and additional data from the CYAD-211 IMMUNICY-1 trial are expected in mid-2022
• Enrollment continues in the KEYNOTE-B79 Phase 1b trial for CYAD-101. Preliminary data from the trial are expected in the second half of 2022
  • In addition, the KEYNOTE-B79 study will be the subject of a presentation at the upcoming American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) Symposium being held from January 20-22, 2022
• Investigational New Drug (IND)-enabling studies continue for CYAD-203. Submission of the IND application for CYAD-203 is expected in the second half of 2022

Mont-Saint-Guibert, Belgium – Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, announced the below information following the issuance on 8 December 2021 of 6,500,000 new shares of Celyad Oncology SA (the “Company”) to an affiliate of Fortress Investment Group (such affiliate “Fortress”). As a result, the Company’s share capital has been increased to 78,584,224.33 EUR and is represented by 22,593,956 shares.

This information is published in accordance with Article 15 of the Belgian Law of 2 May 2007 on the disclosure of major participations in issuers whose shares are admitted to trading on a regulated market and regarding miscellaneous provisions.

Figures – Modified on 8 December 2021 following the capital Increase:

Total amount of share capital (EUR)	78,584,224.33
Total Number of shares with single voting rights	20,225,931
Total Number of shares with double voting rights	2,368,025
Total Number of Shares	22,593,956
Total of voting rights	24,961,981
Total number of attributed warrants	1,997,190
Total number of shares with voting rights that could be created following the exercise of the attributed warrants	1,997,190
Total number of diluted shares (Outstanding shares + Warrants)	24,591,146
Total number of diluted shares with voting rights	26,959,171

Contact person for regulated information (financial, transparency)

By law, any transparency declaration must be sent to our Company by email to the attention of Filippo Petti, Chief Executive Officer (CEO): investors@celyad.com.

Further questions about the content of this release can be sent to investors@celyad.com.

Mont-Saint-Guibert, Belgium – Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, today announced that the Company plans to participate virtually in the following conference in January 2022:

H.C. Wainwright BioConnect 2022 Conference

Dates: Monday, January 10 to Thursday, January 13, 2022

Presentation: On-demand starting January 10, 7 a.m. ET / 1 p.m. CET

Presenter: Filippo Petti, CEO