Celyad Announces Third Quarter 2019 Financial Results and Recent Business Highlights

Regulatory News:

Celyad (Brussels:CYAD) (Paris:CYAD) (NASDAQ:CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, today announced an update on its operational developments for the third quarter ended September 30, 2019.

Filippo Petti, CEO of Celyad stated, “We have reported a steady stream of encouraging news from our pipeline throughout the third quarter and subsequent weeks, including preliminary Phase 1 data for our first-in-class, non-gene edited allogeneic CYAD-101 CAR-T product candidate, the introduction of our proprietary OptimAb manufacturing process to our autologous relapsed/refractory acute myeloid leukemia program led by CYAD-01, and CYAD-02, the acceptance of the IND application for our next-generation candidate CYAD-02, and the advancement of our shRNA technology platform related to our CYAD-200 series of allogeneic product candidates. We continue to establish our position as innovative leaders in the industry as we focus on our core mission of developing innovative CAR-T therapies for cancer patients.”

“In addition, with the closing of our global equity offering in September, we believe the company has sufficient capital resources to enable it to complete its next major clinical milestones, including the upcoming data releases from the CYAD-01 program in relapsed/refractory acute myeloid leukemia,” continued Filippo Petti.

Third Quarter 2019 and Recent Business Highlights

• Successfully dosed the first relapsed/refractory (r/r) acute myeloid leukemia (AML) patient in the DEPLETHINK Phase 1 trial with CYAD-01 produced with OptimAb manufacturing process.
• Presented preliminary data from the ongoing dose-escalation Phase 1 alloSHRINK trial evaluating CYAD-101 at the Society for Immunotherapy of Cancer (SITC) 34^th Annual meeting.
  • Results from the trial demonstrated a favorable tolerability profile for CYAD-101, with encouraging anti-tumor activity in the refectory metastatic colorectal cancer (mCRC). Two patients experienced a confirmed partial response, and five patients experienced stable disease for a period of three months or more. In addition, there was no clinical or laboratory evidence of graft-versus-host disease (GvHD).
  • Completed enrollment in the dose-escalation segment of the alloSHRINK trial with additional results from the trial anticipated during first half 2020.
• Continued advancement of proprietary non-gene edited allogeneic short hairpin RNA (shRNA) platform related to the CYAD-200 series of shRNA-based allogeneic CAR-T candidates.
• Closed global equity offering with gross proceeds of $20.0 million (approximately €18.2 million) in September 2019.

Third Quarter 2019 Financial Review