Celyad Oncology

• Established a clinical trial collaboration with MSD to evaluate CYAD-101 with KEYTRUDA® in patients with microsatellite stable mCRC
• Expect to initiate the expansion cohort of the Phase 1 alloSHRINK trial for CYAD-101 in mCRC patients following FOLFIRI preconditioning chemotherapy by year-end 2020
• Phase 1 dose-escalation trial for lead shRNA-based allogeneic CAR T candidate, CYAD-211, for r/r MM on track to begin by year-end 2020

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 an update on its operational developments for the third quarter ended September 30, 2020.

“We are pleased with the continued momentum seen across our allogeneic clinical programs over the past few months,” commented Filippo Petti, Chief Executive Officer of Celyad Oncology. “Major milestones during third quarter 2020 include expanding the CYAD-101 clinical program for the treatment of metastatic colorectal cancer through our recent clinical trial agreement with MSD to conduct the KEYNOTE-B79 study which will evaluate the potential synergy of pairing CYAD-101 with KEYTRUDA. We are also steadily progressing towards the initiation of the Phase 1 IMMUNICY-1 study by end of year for our anti-BCMA shRNA-based candidate CYAD-211 for the treatment of relapsed/refractory multiple myeloma. In addition, upcoming data from our autologous NKG2D receptor-based CAR T candidates, which we plan to announce at the annual ASH congress, will help guide next steps for our AML franchise.”

Third Quarter 2020 and Recent Business Highlights

• Announced plans to conduct a Phase 1b KEYNOTE-B79 clinical study of non-gene edited allogeneic CAR T therapy CYAD-101 following FOLFIRI (combination of 5-fluorouracil, leucovorin and irinotecan) preconditioning chemotherapy, with MSD’s, a tradename of Merck, anti­PD-1 therapy, KEYTRUDA® (pembrolizumab) in refractory metastatic colorectal cancer (mCRC) patients with microsatellite stable (MSS) / mismatch-repair proficient (pMMR) disease.
• Hosted a Research & Development webinar for investors and analysts on September 29^th, with a replay currently available on the Events page of the Company’s website. Topics covered during the event included:
  • Presentation by Dr. Richard Kim, M.D., Professor of Oncology, Moffitt Cancer Center, on the immuno-oncology and treatment landscapes for mCRC and,
  • Overview of Celyad Oncology’s candidate CYAD-101 for mCRC and CYAD-211 for relapsed / refractory multiple myeloma (r/r MM), and the company’s short hairpin RNA (shRNA) platform and All-in-One vector approach.
• Announced U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application and approval of the Clinical Trial Application (CTA) by the Federal Agency for Medicines and Health Products (FAMHP) of Belgium for the Company’s lead shRNA-based allogeneic candidate CYAD-211, clearing the way to initiate the Phase 1 IMMUNICY-1 clinical trial by the end of 2020.
• Established an Open Market Sale Agreement^SM with Jefferies LLC, pursuant to which the Company may from time to time sell through “an at the market offering” up to $25,000,000 of new American Depositary Shares.

Third Quarter 2020 Financial Review

As of September 30, 2020, the Company ended the quarter with a treasury position of €20.0 million ($23.4 million). Net cash burn during the third quarter of 2020 amounted to €6.7 million ($7.8 million), in line with expectations. The Company confirms its previous guidance that its existing treasury position should be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements into the third quarter of 2021.

Update on Clinical and Preclinical Programs

CYAD-101 – Allogeneic TIM-based, NKG2D receptor-based CAR T for mCRC

Celyad Oncology’s first-in-class, non-gene edited clinical candidate CYAD-101 continues to advance in the alloSHRINK Phase 1 trial for the treatment of mCRC. CYAD-101 co-expresses the NKG2D receptor and the novel inhibitory peptide TIM (TCR Inhibitory Molecule), whose expression reduces signaling of the TCR complex by interfering with the CD3ζ component of the TCR complex. The Company plans to initiate the expansion cohort of the alloSHRINK trial which will evaluate CYAD-101 following FOLFIRI preconditioning chemotherapy in refractory mCRC patients, at the recommended dose of one billion cells per infusion. Enrollment in this expansion cohort is expected to start by year-end 2020.

Planning is also ongoing to initiate the Phase 1b KEYNOTE-B79 study of CYAD-101, following FOLFIRI preconditioning chemotherapy, with MSD’s KEYTRUDA® in refractory mCRC patients with MSS / pMMR disease during the first half of 2021. The Company believes the mechanism of actions between CYAD-101 and KEYTRUDA® are highly complementary and could help to drive meaningful clinical benefit in patients with advanced mCRC.

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 BCMA-targeting chimeric antigen receptor and a single shRNA, which interferes with the expression of the CD3ζ component of the T-cell receptor (TCR) complex. In July 2020, Celyad Oncology announced FDA clearance of its IND application for CYAD-211 and subsequently received CTA approval for CYAD-211 by the FAMHP. The Company plans to initiate the Phase 1 IMMUNICY-1 trial evaluating CYAD-211 following preconditioning chemotherapy in r/r MM by year-end 2020.

CYAD-01 – Autologous NKG2D receptor-based CAR T for r/r AML and MDS

The Company’s first-in-class NKG2D receptor-based CAR T clinical candidate CYAD-01 continues to advance in the ongoing Phase 1 THINK trial for the treatment of patients with r/r acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The Company is scheduled to announce preliminary data from CYAD-01 produced with the OptimAb manufacturing process from the expansion cohort of the Phase 1 THINK trial at the American Society of Hematology (ASH) conference in December 2020.

CYAD-02 – Next-Generation Autologous NKG2D receptor-based CAR T for r/r AML and MDS

CYAD-02 is an investigational CAR T therapy that engineers an All-in-One vector approach in patient’s T cells to express the NKG2D receptor CAR and shRNA to knockdown the expression of NKG2D ligands MICA and MICB on the CAR T cells. The Company is currently conducting the Phase 1 dose-escalation CYCLE-1 trial evaluating CYAD-02 for the treatment of r/r AML and MDS. During the third quarter, the Company initiated the third dose cohort of the trial. The CYCLE-1 trial is assessing the safety and clinical activity of a single infusion of CYAD-02 produced with the OptimAb manufacturing process following preconditioning chemotherapy with cyclophosphamide and fludarabine. Preliminary data from CYCLE-1 trial are expected at the ASH conference in December 2020.

Upcoming Milestones

• Plan to begin enrollment in the expansion cohort of the Phase 1 alloSHRINK trial evaluating CYAD-101 following FOLFIRI preconditioning chemotherapy in refractory mCRC patients by year-end 2020.
• Expect to initiate the dose-escalation Phase 1 IMMUNICY-1 trial evaluating CYAD-211 in r/r MM by year-end 2020.
• Expect to initiate the Phase 1b KEYNOTE-B79 clinical study of CYAD-101 following FOLFIRI preconditioning chemotherapy, with KEYTRUDA® in refractory mCRC patients in first half of 2021.
• Three abstracts accepted for presentation at the annual ASH Meeting & Exposition, being held December 5–8, including:
  • Poster presentation of the Company’s anti-BCMA allogeneic CAR T candidate, CYAD-211
  • Poster presentations of the Company’s autologous NKG2D receptor-based CAR T candidates, CYAD-01 and CYAD-02

Upcoming Conferences

Celyad Oncology’s management team is scheduled to participate in the following conferences during the remainder of 2020:

• Bryan, Garnier & Co. Virtual European Healthcare Conference, November 16, 2020
• Jefferies Virtual London Healthcare Conference, November 17, 2020
• SVB Leerink Oncology 1×1 Day, November 19, 2020
• 62^nd American Society of Hematology Annual Meeting & Exposition, December 5 – 8, 2020

• Three accepted abstracts will be presented virtually in a pre-recorded poster session

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 three abstracts have been accepted for presentation at the 62^nd American Society of Hematology (ASH) Annual Meeting and Exposition, which will be held virtually from December 5-8, 2020. The presentations will focus on the company’s anti-BCMA allogeneic CAR T candidate, CYAD-211, and autologous NKG2D receptor-based CAR T candidates CYAD-01 and CYAD-02. In addition, the abstracts will be published online in the November supplemental issue of peer-reviewed journal Blood.

ASH 2020 Presentation Details:

The following abstracts published today are now available on the ASH conference website. Following their presentation at the meeting, the posters will be available in the Scientific Publications section of Celyad Oncology’s website.

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 at the following conferences in November 2020:

Bryan, Garnier & Co. Virtual European Healthcare Conference

Date: Monday, November 16, 2020

Jefferies Virtual London Healthcare Conference

Date: Tuesday, November 17, 2020

Time: 2:55 p.m. ET / 8:55 p.m. CET

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

SVB Leerink Oncology 1×1 Day

Date: Thursday, November 19, 2020

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 today that the Company has entered into a clinical trial collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ., USA, through a subsidiary.

Celyad Oncology will conduct the Phase 1b KEYNOTE-B79 clinical trial, which will evaluate Celyad Oncology’s investigational non-gene edited allogeneic CAR T candidate, CYAD-101, following FOLFIRI (combination of 5-fluorouracil, leucovorin and irinotecan) preconditioning chemotherapy, with MSD’s anti-­PD-­1 therapy, KEYTRUDA® (pembrolizumab) in refractory metastatic colorectal cancer (mCRC) patients with microsatellite stable (MSS) / mismatch-repair proficient (pMMR) disease.

“We are extremely pleased to enter into this clinical collaboration with MSD, as we believe the mechanism of actions of CYAD-101 and KEYTRUDA are highly complementary and could help to drive meaningful clinical benefit in patients with advanced metastatic colorectal cancer, in particular with microsatellite stable disease where a high unmet medical need exists” said Filippo Petti, Chief Executive Officer of Celyad Oncology. “In addition, the collaboration with MSD adds an important dimension to our clinical program for CYAD-101 for the treatment of mCRC and provides us with the opportunity to build upon the encouraging clinical activity we’ve reported to date from the ongoing alloSHRINK trial.”

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About CYAD-101

CYAD-101 is an investigational, non-gene edited, allogeneic (healthy donor derived) CAR T candidate engineered to co-express a chimeric antigen receptor based on NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands and the novel inhibitory peptide TIM (TCR Inhibitory Molecule). The expression of TIM reduces signaling of the TCR complex, which is responsible for graft-versus host disease.

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 Filippo Petti, Chief Executive Officer, will participate in a fireside chat at the virtual Jefferies Cell Therapy Summit on Monday, October 5, 2020, at 11:00 a.m. EDT.

The live virtual event will be available for investors to listen to via a webcast made available on the Celyad Oncology website. An archived replay of the event will be available on the Company’s website for approximately 30 days.

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 it will host a Research & Development webinar on Tuesday, September 29^th at 11:00 a.m. EDT.

The program will provide insights into the company’s novel, non-gene edited allogeneic CAR T candidates CYAD-101 for metastatic colorectal cancer and CYAD-211 for relapsed / refractory multiple myeloma as well as the company’s short hairpin RNA (shRNA) platform and all-in-one vector approach. The featured speaker, Dr. Richard Kim, M.D., Professor of Oncology, Moffitt Cancer Center, will discuss the immuno-oncology and treatment landscapes for metastatic colorectal cancer. Members of Celyad Oncology’s management will highlight recent developments in the company’s pipeline and discuss the future direction for additional next-generation, allogeneic CAR T candidates.

The live webcast of the presentation can be accessed by visiting the “Events” section of the Celyad Oncology website.  Please connect to the webcast several minutes prior to the start of the event to ensure the connection. To register for the live webcast, click here.  After the conclusion of event, a replay of the webcast will also be available on the Celyad Oncology website.