Celyad Oncology SA announced a 2021 year-end review and provided an outlook for 2022. 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.