• Skip to primary navigation
  • Skip to main content
  • Skip to footer
Show Search
Home
EN / FR
  • LinkedIn
  • Twitter
  • YouTube
Celyad Oncology

Celyad Oncology

  • About Us
    • Overview
    • Management Team
    • Board Of Directors
    • Scientific Advisory Board
    • Partners
  • Science
    • Overview
    • Approach
    • Technology
      • TIM
      • shRNA
    • Manufacturing
    • Scientific Publications
  • Pipeline
  • Newsroom
    • Press Releases
    • Events
  • Investors
    • Overview
    • Analyst Coverage
    • Corporate Governance
    • Regulated Information
    • Shareholders Information
    • Shareholders Meeting
  • Contact Us
    • Careers

Celyad

Celyad to Host Remote 2020 Ordinary General Meeting

April 22, 2020 By Celyad

  • 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.

Download press release(s)
Communiqué de presse
Press Release

Filed Under: Corporate, Regulated

Celyad Reports Full Year 2019 Financial Results and Provides Business Update

March 24, 2020 By Celyad

  • 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

The Company’s lead NKG2D CAR-T clinical candidate CYAD-01 continues to advance in Phase 1 trials for the treatment of patients with r/r AML or MDS. In December 2019, the Company presented the latest data from the CYAD-01 Phase 1 THINK and DEPLETHINK clinical trials at the American Society of Hematology annual meeting. In February 2020, the Company began recruitment in the expansion cohort of the THINK trial evaluating CYAD-01 as a monotherapy. Both the expansion cohort of the THINK trial and the dose-esclation DEPLETHINK trial are now assessing CYAD-01 produced with the Company’s proprietary OptimAb manufacturing process.

CYAD-02 – 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:

 

Selected key financial figures (€ millions)
Full-Year 2019
Full-Year 2018
Revenue
                            –  
                  3.1
Research and Development expenses
                    (25.2)
             (23.6)
General and Administrative expenses
                       (9.1)
             (10.4)
Other income/(expenses)
                         5.4
                (7.3)
Operating loss
                    (28.9)
             (38.2)
Loss for the year
                   (28.6)
             (37.4)
Net cash used in operations
                    (28.2)
             (27.2)
Treasury position(1)
                      39.3
               49.7
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

Download press release(s)
Communiqué de presse
Press Release

Filed Under: Corporate, Regulated

Celyad to Announce Full Year 2019 Financial Results and Host Conference Call

March 12, 2020 By Celyad

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 that the Company will report full year 2019 financial and operating results on the evening of Tuesday, March 24, 2020.

Following the press release, Celyad management will host a conference call on Wednesday, March 25 at 1 p.m. CET / 8 a.m. ET to discuss full year 2019 results and provide an update on the Company’s recent progress and upcoming milestones.

Participants may access the conference call by dialing +44 (0) 2071 928501. The conference ID for the call is 1392585. Alternatively, participants may access the conference call by dialing the following local numbers: Belgium 02 401 70 35, France 01 76 72 89 28, Netherlands 020 7188527 and United States 1 917 720 0181.

To access the subsequent archived recording, visit the “Events & Webcasts” section of the Celyad website.

Additionally, in consideration of growing concerns over the spread of coronavirus disease, COVID-19, the Company has decided to postpone its upcoming Research & Development Day, previously scheduled for March 18th, until later in the year.

Download press release(s)
Communiqué de presse
Press Release

Filed Under: Corporate, Non-regulated

Celyad Appoints Stephen Rubino as Chief Business Officer

March 2, 2020 By Celyad

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 that Stephen Rubino, Ph.D. has been appointed Chief Business Officer. Dr. Rubino has more than 25 years of strong commercial and strategic development experience in the pharmaceutical and biotechnology industry, including 17 years at Novartis. He will serve on the executive leadership team and will lead business and corporate development for Celyad.

“We are excited to have Stephen join Celyad as we continue to grow our executive team’s presence in the U.S. while broadening our global perspective of the industry,” said Filippo Petti, Chief Executive Officer of Celyad. “Stephen has tremendous business development and commercial experience both in and out of the U.S., including directing the commercial development of products that will be invaluable as we advance our clinical CAR-T programs.”  

Most recently, Dr. Rubino was Chief Business & Strategy Officer at Omega Therapeutics. Prior to this position, Dr. Rubino served as Global Head of Business Development and Licensing and New Product Marketing for the Cell and Gene Therapies business unit at Novartis. There, he led growth opportunities including evaluation, licensure and commercial development across a pipeline of cell therapy products. He currently sits on the board of Sermonix Pharmaceuticals and Ilkos Therapeutic. Dr. Rubino received a Ph.D. in virology from Cornell University and an M.B.A. from Baruch College.

Download press release(s)
Communiqué de presse
Press Release

Filed Under: Corporate, Non-regulated

Celyad Announces February and March 2020 Conference Schedule

February 17, 2020 By Celyad

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 that the company plans to participate at the following conferences in February and March 2020:

9th Annual SVB Leerink Global Healthcare Conference
Date:                  Tuesday, February 25, 2020
Presentation time:3:30 p.m. ET
Location:             New York, New York
Webcast:             A live and archived webcast of the presentation will be available in the Events & Webcasts section of the Celyad website
 
3rd Annual CAR-TCR Summit Europe
Date:                  Wednesday, February 26, 2020
Time:                  12:30 p.m. GMT
Location:             London, United Kingdom 
 
27th International Molecular Med Tri-Conference
Date:                   Wednesday, March 4, 2020
Presentation Time:2:35 p.m. PT
Location:              San Francisco, California
 
Cambridge Healthtech Institute’s 5th Annual Immuno-Oncology Summit Europe 2020
Date:                   Wednesday, March 11, 2020
Presentation time: 9:05 a.m. GMT
Location:              London, United Kingdom 
 
BioCapital Europe 2020
Date:                   Thursday, March 12, 2020
Presentation time: 3:50 p.m. CET
Location:              Amsterdam, Netherlands   
 
VFB Congress Happening
Date:                   Saturday, March 28, 2020
Presentation time: 1:40 p.m. CET
Location:              Antwerp, Belgium
Download press release(s)
Communiqué de presse
Press Release

Filed Under: Corporate, Non-regulated

Letter to Shareholders – January 2020

January 28, 2020 By Celyad

Dear Shareholder,

Throughout the past year, we’ve generated a tremendous amount of positive change and focus throughout the company, which has positioned us to deliver new clinical data across our development pipeline in 2020. Each of our programs continue to build momentum as we move towards our goal of bringing cancer patients with poor prognosis innovative new CAR-T therapies. These advancements speak directly to our position as a leader in the CAR-T cell therapy industry.

This exciting time in Celyad’s history is only possible due to the hard work and dedication of each and every one of our team members, patients, physicians and collaborators. And of course, we must thank you, our shareholders, for your continued support and investment in the company as we look towards continued success and progress in 2020 and beyond.

Download press release(s)
Communiqué de presse
Press Release

Filed Under: Letter to Shareholders

  • « Go to Previous Page
  • Go to page 1
  • Go to page 2
  • Go to page 3
  • Go to page 4
  • Interim pages omitted …
  • Go to page 44
  • Go to Next Page »

Footer

  • About
  • Science
  • Pipeline
  • Investors
  • Contact Us
  • LinkedIn
  • Twitter
  • YouTube

Copyright © 2020 All Rights Reserved.
Cookie Policy | Privacy Policy | Terms of Use

Our website uses cookies including analytics cookies to help us improve it by collecting statistics on how visitors use our website. By clicking on “I accept”, you allow us to place these analytics cookies. We also use cookies that are necessary for the good-functioning of our website. You can find more information about the cookies we use by visiting our Cookie Policy.I AcceptI RefuseCookie Policy