Regulated

Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, today announced an update on operational developments for the first quarter ended March 31, 2020.

“I am extremely proud of our team’s dedication and focus over the past few months in progressing the development of our exciting CAR-T therapies during the COVID-19 pandemic. As a result of their efforts, we’ve continued to advance our programs, bringing us closer to several key milestones associated with our clinical and preclinical programs over the course of 2020. Specifically, we anticipate announcing additional data from our CYAD-101 alloSHRINK Phase 1 trial at ASCO, and filing the IND application for our lead shRNA-based allogeneic candidate CYAD-211 over the next few months, as well as providing a clinical update on our relpased/refractory AML and MDS program in the second half of the year,” commented Filippo Petti, CEO of Celyad.

First Quarter 2020 and Recent Business Updates

• Initiation of the Phase 1 CYCLE-1 trial evaluating the next-generation autologous NKG2D receptor CAR-T candidate, CYAD-02, for the treatment of relapsed/refractory (r/r) acute myeloid leukemia (AML) and myleodysplastic syndromes (MDS);
• Appointment of Dr. Stephen Rubino as Chief Business Officer as part of the strategic evolution of the management team;
• Appointment of Dr. Maria Koehler and Mr. Dominic Piscitelli to Board of Directors;
• Scheduled to present an update on the allogeneic NKG2D receptor CAR-T candidate, CYAD-101, for the treatment of refractory metastatic colorectal cancer (mCRC) at 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program on May 29 – 31.

First Quarter 2020 Financial Review

The Company ended first quarter 2020 with a treasury position of €33.8 million ($37.3 million). Net cash burn over the first quarter of 2020 amounted to €5.5 million, which is in line with expectations. The Company confirms its previous guidance that its treasury position should be sufficient to fund operating expenses and capital expenditure requirements, based on the current scope of activities,  through first half 2021.

Update on Clinical and Preclinical Programs

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

The Company’s first-in-class NKG2D CAR-T clinical candidate CYAD-01 continues to advance in Phase 1 trials for the treatment of patients with r/r AML and MDS. During the first quarter of 2020, the Company began recruitment within the expansion cohort of the Phase 1 THINK trial evaluating monotherapy CYAD-01. As reported in March 2020, the Company expects to announce preliminary data from CYAD-01 produced with OptimAb manufacturing process, including the expansion cohort of the Phase 1 THINK trial and the dose-escalation Phase 1 DEPLETHINK trial in the second half of 2020.

CYAD-02 – Autologous NKG2D CAR-T for r/r AML and MDS

In January 2020, the Company announced the first patient was dosed in the Phase 1 dose-escalation CYCLE-1 trial evaluating CYAD-02 for the treatment of r/r AML and MDS. In April, the Company began enrollment in the second 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.

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

The Company’s allogeneic clinical candidate, CYAD-101, which incorporates the non-gene edited T-cell receptor inhibitory molecule (TIM) technology, continues to advance in the Phase 1 alloSHRINK trial. Preliminary data to date has demonstrated no evidence of graft-versus-host disease (GvHD), no dose-limiting toxicity and promising early signals of clinical activity. Based on the initial data, the Company plans to progress to an expansion cohort of the trial to further evaluate CYAD-101 in refractory mCRC patients. The Company expects to report additional data from the dose-escalation segment of the CYAD-101 alloSHRINK Phase 1 trial at the 2020 ASCO Virtual Scientific Program on May 29 – 31.

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

CYAD-211 is the lead program from the Company’s CYAD-200 series of proprietary non-gene edited allogeneic short hairpin (shRNA)-based CAR-T candidates. CYAD-211 targets the B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma (r/r MM).

Upcoming Milestones

• Report additional data from dose-escalation segment of CYAD-101 Phase 1 alloSHRINK trial at ASCO Virtual Scientific Program;
• Submit Investigational New Drug (IND) application for shRNA-based allogeneic BCMA CAR-T candidate CYAD-211 for the treatment of patients with r/r MM by mid-2020;
• Begin expansion cohort of CYAD-101 alloSHRINK Phase 1 trial during second half 2020;
• Report preliminary data from CYAD-01 produced with OptimAb manufacturing process including expansion cohort of Phase 1 THINK and dose-escalation Phase 1 DEPLETHINK trials during second half of 2020; and
• Report preliminary data from dose-escalation Phase 1 CYCLE-1 trial for CYAD-02 by year-end 2020.

• Company postpones Extraordinary General Assembly from May 5, 2020 to June 8, 2020

Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, today announced the decision to host its 2020 Ordinary General Meeting remotely on May 5, 2020 and to postpone its Extraordinary General Meeting to June 8, 2020 from May 5, 2020.

Materials for both the Ordinary and Extraordinary Shareholders’ Meetings can be found on the Investors section of the Company’s website under “Shareholder Meetings”.

Ordinary Shareholders’ Meeting of May 5, 2020

In view of the current exceptional circumstances linked to the COVID-19 pandemic and in accordance with Belgian Royal Decree No. 4 of April 9, 2020, the Board of Directors of Celyad have decided to prohibit the physical presence of shareholders, and instead will webcast the Ordinary General Meeting of May 5, 2020 remotely, via an electronic means of communication.

The detailed practical arrangements for the broadcasting of this Ordinary General Meeting will be published on Celyad’s website.

Voting instructions can only be submitted by proxy to the proxyholder designated by the Board of Directors of Celyad. With respect to the right to ask questions, shareholders are allowed to submit their questions only in writing prior to the Ordinary General Meeting.

The other formalities for admission to and participation in the meeting (conditions of admission, right to ask questions and consultation of the available documents) remain unchanged from the information provided in the notice of meeting published on April 3, 2020.

Extraordinary Shareholders’ Meeting of May 5, 2020

In addition, the Board of Directors of Celyad have also decided to postpone the Extraordinary General Meeting initially scheduled for May 5, 2020 until June 8, 2020 at 3:00 pm CEST. The agenda of this meeting will remain the same, including:

1. Acknowledgement of the special report of the Board of Directors drawn up in accordance with article 7:199 of the Companies and Associations Code
2. Renewal of authorized capital
3. Change the Company’s name
4. Powers

This postponement decision was adopted in view of the exceptional circumstances related to the COVID-19 pandemic and, specifically, the difficulties encountered by our shareholders of the American depositary receipts in expressing their vote if the date of May 5, 2020 had been maintained. As a reminder, the meeting had been convened with a reduced notice period in application of article 7:128 §1 of the Code of Companies and Associations.

Information on the modalities and other arrangements made for the holding of this Extraordinary General Meeting will be communicated at a future date.

• First patient successfully dosed in expansion cohort of autologous CYAD-01 THINK trial  for  patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS)
• CYCLE-1 trial of autologous CYAD-02 for the treatment of r/r AML and MDS ongoing
• Expansion cohort of alloSHRINK trial evaluating allogeneic CYAD-101 for metastatic colorectal cancer (mCRC) on target to begin in second half 2020
• Submission of IND for short hairpin RNA (shRNA)-based allogeneic CYAD-211 candidate for multiple myeloma (MM) expected in mid-2020
• Treasury position of €39.3 million ($44.0 million) as of December 31, 2019

Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, today announced its consolidated financial results for fiscal year 2019 ended December 31, 2019 and provided a business update.

“This is an exciting time for us as we advance Celyad as an innovative leader in the industry which is focused on developing CAR-T therapies for cancer patients. The progress we made throughout 2019 positions Celyad with a balanced pipeline of clinical and preclinical CAR-T candidates as we enter the new decade with several milestones on the horizon,” commented Filippo Petti, Chief Executive Officer of Celyad. “We now have two autologous clinical CAR-T candidates in development for the treatment of r/r AML and MDS and a portfolio of promising allogeneic CAR-T candidates, led by CYAD-101, for the treatment of mCRC. We look forward to providing key updates on our clinical progress throughout 2020. Over the past year, we also progressed our shRNA platform for next-generation CAR-T candidates, including our preclinical allogeneic BCMA-targeted candidate, CYAD-211. I am extremely proud of our team’s achievements over the past twelve months and look forward to a productive 2020.”

Recent Business Highlights and Pipeline Updates

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

In January 2020, the Company announced the first patient has been dosed in the Phase 1 dose-escalation CYCLE-1 trial evaluating the next-generation NKG2D-based CAR-T candidate for the treatment of r/r AML and MDS. The CYCLE-1 trial will evaluate 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. The trial will evaluate three dose levels of CYAD-02 up to one billion cells per infusion.

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

The Company’s allogeneic NKG2D CAR-T clinical candidate CYAD-101, which incorporates the non-gene edited T-cell receptor Inhibitory Molecule (TIM) technology, continues to advance in the dose-escalation alloSHRINK trial assessing the safety and clinical activity of CYAD-101 administered concurrently with FOLFOX chemotherapy in patients with r/r mCRC. In November 2019, preliminary data  from the ongoing alloSHRINK trial were presented at the Society for Immunotherapy of Cancer annual meeting and showed no clinical evidence of Graft-versus-Host Disease post-infusion of CYAD-101. In addition, encouraging anti-tumor activity with two out of 12 patients experiencing a partial response and five patients experiencing stable disease with a minimum of three months of duration. Based on the preliminary data from the Phase 1 alloSHRINK trial, the Company plans to expand the trial to confirm initial safety and clinicial activity of  CYAD-101 with chemotherapy in refractory mCRC patients.

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

The Company continues to pursue the development of the proprietary non-gene edited allogeneic shRNA SMARTvector platform through the CYAD-200 series of product candidates. The Company’s lead preclinical CAR-T candidate from the series, CYAD-211, targets B-cell maturation antigen (BCMA) for the treatment of relapsed / refractory multiple myeloma (r/r MM). The Company continues to progress towards submitting an Investigational New Drug (IND) application for CYAD-211.

Update on COVID-19 Pandemic

In light of the outbreak of the novel coronavirus, COVID-19, the Company has implemented strong measures to help prevent the spread of the virus and protect our employees. In addition, we have put into practice our business continuity plan to minimize the impact on our operations. While the Company is not currently experiencing any major disruptions in its business related to COVID-19, given the recent developments associated with the virus both in Belgium and in the United States and due to recently adopted government policies, the Company does anticipate enrollment delays within our r/r AML and MDS program. The Company is continuing to monitor the impact of COVID-19 on both our clinical and non-clinical planned milestones below and will adjust accordingly as the pandemic continues to rapidly evolve. 

Upcoming Milestones

• Report additional data from the dose-escalation segment of the CYAD-101 alloSHRINK Phase 1 trial during the second quarter of 2020
• Submit IND application for an shRNA-based allogeneic BCMA CAR-T candidate, CYAD-211, for the treatment of patients with r/r MM by mid-2020
• Report preliminary data from expansion cohort of the Phase 1 THINK and dose-escalation Phase 1 DEPLETHINK trials evaluating CYAD-01 produced with OptimAb manufacturing process during second half of 2020, due to enrollment delays caused by the COVID-19 pandemic
• Begin expansion segment of the CYAD-101 alloSHRINK Phase 1 trial during the second half of 2020
• Report preliminary data from the dose-escalation Phase 1 CYCLE-1 trial for CYAD-02 by year-end 2020

2019 Financial Results

As of December 31, 2019, Celyad had a treasury postion of approximately €39.3 million ($44.0 million). The Company expects that the existing treasury position will be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements through the first half of 2021.

Key financial figures for full-year 2019, compared with full-year 2018, are summarized below:

1. Treasury position’ is an alternative performance measure determined by adding Short-term investments and Cash and cash equivalents from the statement of financial position prepared in accordance with IFRS.

The Company’s license and collaboration agreements generated no revenue for the year ended December 31, 2019, compared to €3.1 million for the year ended December 31, 2018.

Research and development expenses were €25.2 million for the year ended December 31, 2019, compared to €23.6 million for the year ended December 31, 2018. The €1.6 million increase was primarily driven by spending related to the Company’s preclinical product candidates and its investments in process development, scale-up and automation of its manufacturing processes.

General and administrative expenses were €9.1 million for the year ended December 31, 2019, compared to €10.4 million for the year ended December 31, 2018. The difference of €1.3 million was primarily due to the decrease of non-cash expense associated with the vesting of warrants and lower consulting fees for the period.

The Company’s other income/other expenses mainly include:

• Non-cash expenses relating to liability reassessment, required by International Financial Reporting Standards (IFRS), associated with the advancement in the Company’s NKG2D CAR-T candidates. Overall, the Company posted €0.3 million in net profit for the year ended December 31, 2019, compared to a net loss of €6.6 million for the year ended December 31, 2018;
• Government grant income of €3.3 million for the year ended December 31, 2019, primarily due to new grants from the Walloon Region received in the fourth quarter of 2019, compared to grant income of €0.8 million for the year ended December 31, 2018;
• R&D tax credit, recognized as income, of €1.6 million for the year ended December 31, 2019, compared to income of €0.3 million for the year ended December 31, 2018.

Net loss was €28.6 million, or €(2.29) per share, for the year ended December 31, 2019, compared to a net loss of €37.4 million, or €(3.36) per share, for the same period in 2018. The decrease in net loss between periods was primairly due to the increase in net other income.  

Net cash used in operations, which excludes non-cash effects, for the year ended December 31, 2019 amounted to €28.2 million, compared to €27.2 million for the same period in 2018. The difference was driven primarily by an increase in spend associated with Research and Development described above.

Annual Report 2019

The Annual Report for the year ended December 31, 2019 will be published tomorrow, March 25, 2020, and will be available on the Company’s website, www.celyad.com. The Company’s statutory auditor, BDO Réviseurs d’Entreprises SCRL (BDO), has confirmed that the completed audit has not revealed any material misstatement in the consolidated financial statements. BDO also confirmed that the accounting data reported in the press release are consistent, in all material respects, with the consolidated financial statements from which it has been derived.

Conference Call and Webcast Details

A conference call will be held on Wednesday, 25 March at 1:00 p.m. CET / 8:00 a.m. ET to review the financial and operating results for full year 2019. Please dial-in five to ten minutes prior to the call start time using the number and conference ID below:

Conference ID:                     1392585

International:                       +44 (0) 2071 928501

Belgium                               +32 (0) 24 01 70 35

France                                 +33 (0)1 76 72 89 28

Netherlands                          + 31 (0) 20 71 88 527

United States:                      +1 917 720 0181

Financial Calendar

                      Annual shareholders meeting                   May 5, 2020

                      First quarter 2020 business update           May 7, 2020

                      Half-year results 2019                             August 6, 2020

                      Third quarter 2020 business update          November 10, 2020