Celyad Oncology Announces Third Quarter 2020 Financial Results and Recent Business Highlights
November 10, 2020 10:01 p.m. CET
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 29th, 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 AgreementSM 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.