Uncategorized

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 U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the CYAD-101-002 (KEYNOTE-B79) Phase 1b trial after the Company made changes to the eligibility criteria for the trial.

“We are pleased that the FDA lifted the clinical hold on this trial. We remain confident in the potential development of not only the candidate itself, but the continued development with our proprietary TIM technology. CYAD-101 is currently our only clinical candidate co-expressing NKG2D and TIM, and we hope to continue to showcase our expertise with our non-gene edited technologies and explore additional opportunities to utilize NKG2D in allogeneic CAR T,” said Dr. Charles Morris, Chief Medical Officer of Celyad Oncology.

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. The trial was subsequently put on clinical hold in March 2022 by the FDA.

The CYAD-101-002 Phase 1b trial evaluates 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.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. 

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 will report first half 2022 financial and operating results on the morning of Friday, August 5, 2022.

Following the press release, Celyad Oncology management will host a conference call that day Friday, August 5 at 2 p.m. CEST / 8 a.m. EDT to discuss first half 2022 results and provide an update on the Company’s recent progress and upcoming milestones.

Participants may access the conference call by dialing +1 201 493 6779 (International), + 1 877 407 9716 (United States) or +32 (0) 800 73 904 (Belgium) and ask to be joined into the Celyad Oncology SA call.

To access the live webcast and archived recording, visit the “Events” section of the Celyad Oncology website.

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 the Board of Directors has named Hilde Windels as Chairwoman of the Board of Directors, effective immediately. Ms. Windels has been a member of the Board of Directors since May 2018. Ms. Windels serves on multiple boards in the life sciences industry and has been an executive in the sector from 1999 through 2021, serving primarily as Chief Financial Officer and, over the last five years, as Chief Executive Officer. Ms. Windels succeeds Michel Lussier who has been named Interim Chief Executive Officer of the Company, effective immediately. Mr. Lussier is a co-founder of the Company and has been a member of the Board of Directors since 2007. Mr. Lussier succeeds Filippo Petti who has resigned as Chief Executive Officer, Chief Financial Officer and member of the Board of Directors to pursue other opportunities. Mr. Petti will serve as a consultant to the Company through July 31, 2022 to ensure an effective transition while the Board of Directors commences a search for a permanent Chief Executive Officer.

“I would like to thank Filippo for his significant contribution to Celyad Oncology. Under his leadership, the Company has become a key player in the CAR T cell therapy landscape, providing a strong foundation on which Celyad Oncology can enter its next strategic phase,” commented Michel Lussier, Interim Chief Executive Officer.

Hilde Windels, Chairwoman of the Board of Directors added, “On behalf of the Board of Directors, I would like to express our gratitude for Filippo’s dedication and efforts. We wish him all the success in his future endeavors as we look forward to continuing the execution of Celyad Oncology’s strategy of building a dynamic biotechnology company in the field of allogeneic CAR T.”

Mont-Saint-Guibert, Belgium – Celyad Oncology SA (Euronext & Nasdaq: CYAD) (the “Company”), a clinical-stage biotechnology company focused on the discovery and the development of Chimeric Antigen Receptor T cell (CAR T) therapies for cancer, announced that 350 registered shares benefit from a double voting right as of May 25, 2022. As a result, the Company’s total number of voting rights is now 24,962,331.

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 25 May 2022 following the Double Voting Rights:

Total amount of share capital (EUR)	78,584,224.33
Total Number of shares with single voting rights	20,225,581
Total Number of shares with double voting rights	2,368,375
Total Number of Shares	22,593,956
Total of voting rights	24,962,331
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	26,959,521

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) (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 the Company plans to participate virtually at the upcoming H.C. Wainwright Global Investment Conference, May 23 – 26, 2022.

The Company’s presentation will be available on-demand through the H.C. Wainwright conference portal, starting at 7:00 a.m. EST on Tuesday, May 24, 2022.

• Enrollment continues in Phase 1 dose-escalation IMMUNICY-1 trial for lead shRNA-based allogeneic CAR T candidate, CYAD-211, for relapsed/refractory multiple myeloma (r/r MM)
• Dialogue continues with regulatory agencies concerning CYAD-101-002 Phase 1b trial, which remains on clinical hold

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 an update on its financial results and recent business developments for the fiscal quarter ended March 31, 2022.

“The first quarter of 2022 brought us both challenges and opportunities that we are facing head-on. While we continue to investigate the recent developments in the CYAD-101 Phase 1b trial, we are making great progress with our shRNA-based allogeneic programs, including CYAD-211, for which we anticipate announcing additional data during the second half of the year,” commented Filippo Petti, Chief Executive Officer of the Company. “We are truly thankful for our hardworking team and the support of our shareholders while we advance towards our milestones for the year and further enhance our allogeneic CAR T investigational therapies with our proprietary non gene edited technologies.”

Update on Clinical and Preclinical Programs

CYAD-211 – Allogeneic shRNA-based, anti-BCMA CAR T candidate for r/r MM

• The dose-escalation Phase 1 IMMUNICY-1 trial is evaluating the tolerability and clinical activity of a single infusion of CYAD-211 following preconditioning with CyFlu (cyclophosphamide and fludarabine) in patients with relapsed / refractory multiple myeloma (r/r MM).
  • The current segment of the IMMUNICY-1 study is evaluating CYAD-211 following enhanced lymphodepleting (eLD) regimens with the aim to improve cell expansion and persistence and potentially maximize the clinical activity of CYAD-211. In addition, the IMMUNICY-1 protocol allows for redosing of CYAD-211 in certain patients.
  • Enrollment in the eLD cohorts of the IMMUNICY-1 trial continues with additional data expected from the program in the second half of 2022.

CYAD-101 – Allogeneic TIM-based, NKG2D CAR T Candidate for Metastatic Colorectal Cancer (mCRC)

• In February 2022, the Company voluntarily paused the Phase 1b trial of CYAD-101 after two fatalities occurred that presented with similar pulmonary findings. Subsequently, in March 2022, the Company was informed by the U.S. Food and Drug Administration that the CYAD-101-002 Phase 1b trial had been placed on clinical hold.
• The Company continues to investigate these findings in the CYAD-101-002 Phase 1b trial and is evaluating any similar events in additional patients treated in the study, while also working with appropriate regulatory authorities. The Company expects to provide additional updates on the trial in the future.

shRNA Armored CAR (shARC) Franchise

• Research continues in multiple discovery programs focused on the co-expression of Interleukin-18 (IL-18) in conjunction with our short hairpin RNA (shRNA) technology platform, also known as our shARC (shRNA Armored CAR) franchise.
• In April, the Company decided to stop the development of CYAD-203, an allogeneic shRNA-based, IL-18-armored NKG2D CAR T candidate following the analysis of preclinical data from multiple investigational new drug application (IND)-enabling studies. The Company continues to explore back-up allogeneic NKG2D receptor CAR T candidates currently in discovery stage that leverage the Company’s shARC platform. 

First Quarter 2022 Financial Review

As of March 31, 2022, the Company had cash and cash equivalents of €20.5 million ($22.9 million). Net cash burn during the first quarter of 2022 amounted to €9.5 million ($10.6 million), in line with expectations. The Company confirms its previous guidance that its existing cash and cash equivalents, combined with the remaining access to the equity purchase agreement established with Lincoln Park Capital Fund, LLC, should be sufficient to fund operating expenses and capital expenditure requirements until mid-2023.

Financial Calendar

First Half 2022 Financial Results …………………… August 5, 2022

Third Quarter 2022 Financial Results ……………….. November 10, 2022