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Uncategorized

Shareholders Approve Rebranding as Celyad

June 9, 2020 By Celyad

  • Shareholders approve new name which better reflects the Company’s ambition to pioneer CAR T cell therapies for cancer 

Mont-Saint-Guibert, Belgium – Celyad SA (Euronext & Nasdaq: CYAD), clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, today announced the launch of its corporate rebranding, including changing its name to Celyad Oncology. The new name highlights the Company’s significant progress with its next-generation CAR T programs and emphasizes its commitment to cancer patients. 

As part of the rebranding, the Company also introduced a new logo and launched a new corporate website, www.celyad.com. The Company’s common stock will continue trading on the Euronext and Nasdaq Global Market exchanges under the ticker symbol “CYAD”. 

“Our rebranding under Celyad Oncology more accurately reflects our team’s expertise in developing innovative cell therapies against cancer,” said Filippo Petti, CEO of Celyad Oncology. “As we embark on this next chapter, we look forward to our continued evolution as we strive to shape the future of our off-the-shelf and personalized CAR T cell therapies for cancer patients with unmet medical needs. In addition, today’s announcement offers us the opportunity to reiterate our strong position in the field of oncology and increased strategic focus in our allogeneic CAR T franchise on the heels of our recent update at the American Society of Clinical Oncology conference, which featured our non-gene edited allogeneic candidates and technology platforms.” 

About Celyad Oncology 

Celyad Oncology is a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer. The Company is developing a pipeline of allogeneic (off-the-shelf) and autologous (personalized) CAR T cell therapy candidates for the treatment of both hematological malignancies and solid tumors. Celyad Oncology was founded in 2007 and is based in Mont-Saint-Guibert, Belgium and New York, NY. The Company has received funding from the Walloon Region (Belgium) to support the advancement of its CAR T cell therapy programs. For more information, please visit www.celyad.com. 

Forward-Looking Statement 

This release may contain forward-looking statements, within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may include statements regarding: the safety and clinical activity of Celyad Oncology’s pipelines and financial condition, results of operation and business outlook. Forward-looking statements may involve known and unknown risks and uncertainties which might cause actual results, financial condition, performance or achievements of Celyad Oncology to differ materially from those expressed or implied by such forward-looking statements. Such risk and uncertainty includes the duration and severity of the COVID-19 pandemic and government measures implemented in response thereto. A further list and description of these risks, uncertainties and other risks can be found in Celyad Oncology’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in its Annual Report on Form 20-F filed with the SEC on March 25, 2020 and subsequent filings and reports by Celyad Oncology. These forward-looking statements speak only as of the date of publication of this document and Celyad Oncology’s actual results may differ materially from those expressed or implied by these forward-looking statements. Celyad Oncology expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless required by law or regulation. 

Investor and Media Contacts: 

Alexandrine Hazard 

Communications & Investor Relations Associate 

Celyad Oncology 

investors@celyad.com 

Daniel Ferry 

Managing Director 

LifeSci Advisors, LLC 

daniel@lifesciadvisors.com 

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Filed Under: Uncategorized

Celyad’s 2019 R&D Day Highlights shRNA Platform and Pipeline of Next-generation NKG2D-based and Off-the-Shelf Non-gene Edited CAR-T Candidates

March 18, 2019 By Celyad

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Celyad to Participate at Upcoming Healthcare Conferences

November 15, 2018 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 management will participate at both the Bryan, Garnier & Co 6th European Healthcare Conference and the Piper Jaffray 30th Annual Healthcare Conference.

The Bryan, Garnier & Co 6th European Healthcare Conference will take place in Paris, France, on November 22-23, 2018.  The Company will participate in investor meetings at the Conference.

The Piper Jaffray 30th Annual Healthcare Conference will take place in New York, NY on November 27-29, 2018 and the Company is scheduled to participate in a fireside chat on Tuesday, November 27 at 11:30 am Eastern Time.  A live webcast of the discussion can be accessed here.  An archived webcast recording will also be available under Events & Webcasts in the Investors section of the Company’s website.

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Filed Under: Corporate, Non-regulated, Uncategorized

Celyad to Present New CYAD-01 Data from THINK Study in Relapsed/Refractory Acute Myeloid Leukemia at 2018 ASH Annual Meeting

November 1, 2018 By Celyad

Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell-based therapies, today announced that two abstracts detailing updated clinical results from the Phase 1 THINK dose-escalation trial and anticipated clinical trials for the CYAD-01 program will be presented at the 60th American Society of Hematology (ASH) Annual Meeting in San Diego, December 1-4, 2018.

  • Oral presentation highlighting updated THINK study data evaluating CYAD-01 without preconditioning chemotherapy in relapsed or refractory (r/r) acute myeloid leukemia (AML)
  • As of July 2018, three out of seven (42%) r/r AML patients evaluable for response achieved a complete response (CRh/CRi) following treatment with the per-protocol dose of CYAD-01
  • Overall, five out of seven (71%) patients achieved meaningful decrease in bone marrow blasts
  • Company to host Analyst/Investor event on Monday, December 3, 2018

Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell-based therapies, today announced that two abstracts detailing updated clinical results from the Phase 1 THINK dose-escalation trial and anticipated clinical trials for the CYAD-01 program will be presented at the 60th American Society of Hematology (ASH) Annual Meeting in San Diego, December 1-4, 2018. Company management will also review the results of the THINK trial and provide an update on Celyad’s clinical development program for CYAD-01 at an Analyst/Investor event, which will also be available via webcast on December 3, 2018.

“We are encouraged by the preliminary THINK study data evaluating CYAD-01, without preconditioning chemotherapy in patients with relapsed or refractory acute myeloid leukemia,” said Dr. Christian Homsy, CEO of Celyad. “The data supplement a growing body of evidence that CYAD-01 shows encouraging clinical activity and is well-tolerated and suggests its potential for the treatment of acute myeloid leukemia, a challenging disease with limited therapeutic options. In addition to this important milestone, we continue to investigate CYAD-01 in alternative protocols to further optimize its clinical benefit.”

Updated data from the THINK trial of CYAD-01 in patients with r/r AML will be presented by Principal Investigator David A. Sallman, M.D., of the Moffitt Cancer Center, on December 3, 2018. The presentation will include new information on safety, activity and correlative science data of the complete dose-escalation segment of the trial.

Top-line data from the abstract as of a data cut-off date of July 31, 2018, included:

  • Of the seven response-evaluable r/r AML patients enrolled in the trial who received the per-protocol dose of CYAD-01, the best overall response rate was 42% (three patients). Two additional patients experienced important clinical benefit with hematologic improvement and bone marrow blasts decrease, leading to clinical activity of 71% (five patients).
  • One patient experienced a complete remission with partial hematologic recovery (CRh) and two patients experienced a complete remission with incomplete marrow recovery (CRi). One CRh and one CRi occurred at dose level 1 (DL1) with an additional CRi at dose level 3. All three responders achieved a response by day 29 (i.e., prior to the third administration of CYAD-01).
  • The patient with CRh from DL1 was bridged to allogeneic hematopoietic stem cell transplantation (allo-HSCT) on day +97 post treatment with CYAD-01. This patient remains in durable complete molecular remission (CRMRD-) for more than one year (ongoing). A detailed case report of this patient was published in Haematologica in April 2018.
  • Of the two additional r/r AML patients who experienced a clinical benefit, one patient had a decrease in blast counts from 24% to 10%, while a second patient had a decrease from 9.8% to 5.5%. Disease stabilization in these patients were observed for three months and over four months (ongoing), respectively. Both patients were treated in dose level 2 of the study.
  • Overall, 12 patients with hematological malignancies (AML, myelodysplastic syndrome and multiple myeloma) treated with CYAD-01 in the cohort had reached the safety follow-up. The most common treatment-related adverse events (AEs) included pyrexia, cytokine release syndrome (CRS), hypoxia, lymphopenia, fatigue and nausea. CRS occurred in five patients (three grade 1/2 AEs and two grade 3 AEs), with rapid resolution following the appropriate treatment, including tocilizumab. Overall, five patients experienced grade 3/4 treatment-related AEs. No neurotoxicity AEs were observed in patients treated with CYAD-01.

CYAD-01 and THINK Trial Design

CYAD-01 is an investigational CAR-T therapy in which a patient’s T cells are engineered to express the chimeric antigen receptor NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells.

The THINK trial (NCT03018405) is an open-label, dose-escalation Phase 1 trial assessing the safety and clinical activity of multiple CYAD-01 administrations without prior preconditioning in two parallel cohorts: i) patients with hematological malignancies, including r/r AML, and ii) patients with metastatic solid tumors. The dose escalation segment of the study evaluates three dose levels (300 million, 1 billion and 3 billion cells per injection) of one cycle of three CYAD-01 administrations with two-week intervals.

ASH Analyst/Investor Event and Webcast Information

Celyad will host an Analyst/Investor event on Monday, December 3, 2018, beginning at 8:30 p.m. PT to review data presented at ASH. The event will be webcast live and can be accessed under Events & Webcasts in the Investors section of the Company’s website.

A complete list of Celyad and collaborator presentations to be made at ASH appears below:

Oral Presentation

Remissions in Relapse/Refractory Acute Myeloid Leukemia Patients Following Treatment with NKG2D CAR-T Therapy Without a Prior Preconditioning Chemotherapy (Abstract #111326 – Publication Number 902)

Presenter: David A. Sallman, M.D., Moffitt Cancer Center

Date: Monday, December 3, 2018, 4:45 p.m. Pacific Time

Location: Manchester Grand Hyatt San Diego, Seaport Ballroom F

Poster Presentation

Phase 1 Studies Assessing the Safety and Clinical Activity of Multiple Doses of a NKG2D-based CAR-T Therapy, CYAD-01, in Acute Myeloid Leukemia (Abstract #114747 – Publication Number 1398)

Presenter: Jason B Brayer, MD, Moffitt Cancer Center

Date: Saturday, December 1, 2018, 6:15 PM – 8:15 PM

Location: San Diego Convention Center, Hall GH

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Celyad Reports First Half 2018 Financial Results and Operational Progress

August 23, 2018 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 therapies, today announced its consolidated financial results for the six-month period ending 30 June 2018 prepared in accordance with IFRS as endorsed by the European Union.

Conference call scheduled for Thursday, 23 August at 2:00 p.m. CEST / 8:00 a.m. EDT

  • Dose escalation portion of THINK[1] clinical trial in solid arm completed
  • Successful administration of CYAD-01 in first patients in SHRINK[2] and LINK[3]trials
  • Initiation of EPITHINK[4] and DEPLETHINK[5] clinical trials following FDA acceptance of IND applications
  • Haematologica publication of THINK study case report
  • Strong cash position after completion of Celyad’s €46.1 million global offering
  • Strengthening of the Board of Directors and Scientific Committee with the appointment of the former CSO of Kite Pharma, Dr. Margo Roberts

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 the six-month period ending 30 June 2018 prepared in accordance with IFRS as endorsed by the European Union. The full interim financial report is available on Celyad’s website in the “Investors” section. The half year 2018 consolidated financial statements were subject to a limited review by the company’s statutory auditors.

“We are very pleased with the progress made by Celyad in the first half of 2018, with significant advancement of our clinical programs for CYAD-01 across a number of programs in which, to date, we have observed preliminary signs of activity and a favorable tolerability profile”, commented Dr. Christian Homsy, CEO of Celyad. “We are particularly encouraged by the progress we have made in the hematological arm of our THINK trial and are thrilled that last month the FDA permitted our IND application to go into effect for CYAD-101, the world’s first non-gene edited allogeneic CAR-T clinical program. We are confident that 2018 will be a milestone year for Celyad as we continue to advance our platform across multiple indications.”

Operational Highlights

Progress made in Acute Myeloid Leukemia (AML)

THINK Trial

  • Interim results demonstrate signs of clinical activity ranging from complete responses to stable diseases at lower doses in AML patients receiving one cycle of CYAD-01 per protocol.
  • Twelve patients[6] have been enrolled to date. Enrollment for the highest dose (3×109) is expected to be completed in September 2018.
  • A complete second cycle of investigational therapy was administered in the first AML patient enrolled into the second dose level (1×109).  A second AML patient at the third dose level (3×109) has received the first injection of the second cycle. The second cycle is administered to determine the impact of the clinical benefit of additional CYAD-01 administrations. No dose-limiting toxicity has been observed to date.
  • The first ever reported complete response by an investigational CAR-T cell therapy without preconditioning in a patient with refractory and relapsed AML was published as a case study in Haematologica.
  • Preliminary results of the dose escalation segment will be reported in December during the American Society for Hematology (ASH) Annual Meeting (December 1-4, San Diego).

EPITHINK Trial

  • Based on feedback from the FDA, we finalized the EPITHINK protocol – a trial evaluating the synergetic effect of the concurrent administration of CYAD-01 (CAR-T NKG2D) with a standard of care hypomethylating agent (HMA) i.e. 5-azacytidine (AZA) in treatment-naïve Acute Myeloid Leukemia (AML) or myelodysplastic syndrome (MDS) patients not candidates for intensive therapy.

DEPLETHINK AML Trial

  • Based on feedback from the FDA, we finalized the DEPLETHINK AML protocol – a trial to evaluate administration of CYAD-01 after a traditional preconditioning regimen in refractory/relapsing AML and MDS patients.

Progress made in Colorectal Cancer (CRC)

THINK Trial

  • Fourteen solid cancer patients (one pancreas, two ovarian and eleven CRC) completed the three dose-levels evaluated in the dose escalation segment.
  • One dose-limiting toxicity (DLT) was reported at the highest dose-level (3×109) triggering the enrollment of three additional patients. No other DLT was reported in the three additional patients treated at the third dose level.
  • Preliminary results will be reported during the Society for Immunotherapy of Cancer (SITC) Annual Meeting (November 7-11, Washington).

SHRINK Trial

  • Three CRC patients were treated at the first dose level (1×108) with no dose-limiting toxicity reported to date in combination with current standard of care.

LINK Trial

  • One CRC patient has received three local hepatic transarterial injections at the first dose level (3×108) with no dose-limiting toxicity reported to date.

DEPLETHINK CRC Trial

  • This study evaluates the administration of CYAD-01 after traditional preconditioning regimen in patients suffering from colorectal cancer. The first patient has been registered.

Subsequent Operational Events to First Half

In July, Celyad’s Investigational New Drug (IND) application went into effect with the FDA for CYAD-101, the world’s first non-gene edited allogeneic CAR-T clinical program. CYAD-101 is the first of a family of investigational non-gene edited allogeneic CAR-T cell therapies that will draw on the experience from the SHRINK autologous CAR-T program to target colorectal cancer. The FDA also indicated that the Allo-SHRINK trial, evaluating the safety and clinical activity of CYAD-101 in patients with unresectable colorectal cancer in combination with standard chemotherapy, is allowed to proceed.  

Corporate and Financial Highlights for the First Half of 2018

In May, Celyad successfully completed a global offering with gross proceeds of approximately $54.4 million (approximately €46.1 million). At the end of June 2018, the Company reported total cash and short-term investments of €63 million, which are expected to be sufficient to support its operating capital expenditure into mid-2020.

In early August, Margo Roberts, Ph.D., joined Celyad’s Board of Directors and scientific committee. Dr. Roberts was Chief Scientific Officer at Kite Pharma, Inc., before becoming Senior Vice President of Discovery Research where she focused on next therapeutic approaches including Kite’s allogeneic T-cell programs. With Dr. David Gilham, Celyad’s VP of R&D, she will provide input into the scientific strategy of the company.

Also, in August, the Company announced the appointment of Filippo Petti as Chief Financial Officer as from 3 September, succeeding Patrick Jeanmart. Prior to joining Celyad, Mr. Petti served as VP of Healthcare Investment Banking at Wells Fargo Securities and William Blair & Company. His deep industry expertise, experience in oncology and connectivity within the U.S. investor community will help Celyad’s development in the U.S. capital and financial market.

Commenting on the 2018 half year results, Patrick Jeanmart, Chief Financial Officer of Celyad, said: “Thanks to the successful capital raise made last May, we reported a comfortable cash position which we expect will be sufficient to support Celyad’s operating expenses and capital expenditure requirements, based on the current scope of our activities, into mid-2020. We are committed to careful oversight of our cash and resource management allowing the meaningful advancement of our preclinical and clinical CAR-T platform across multiple indications.”

Selected First Half 2018 Financial Results

In million eurosH1 2018H1 2017
Revenues2.53.5
Research & development expenses(11.1)(11.1)
General & administrative expenses(5.5)(4.2)
Other income/(expenses)(4.7)(1.3)
Operating loss(18.8)(13.7)
Loss of the period(18.5)(14.4)
Loss per share (in €)(1.79)(1.52)
Net cash used in operations(13.9)(14.5)
Cash and short-term investment63.268.8

Conference Call Details

Celyad’s management will host a conference call on Thursday, 23 August 2018 at 2:00 p.m. (CEST) / 8:00 a.m. (EDT) to comment on the mid-year operational and financial results. Patrick Jeanmart, CFO, will deliver a brief presentation followed by a Q&A session.

Participants are asked to call the assigned numbers approximately five minutes before the conference call begins.

The call can be accessed by dialling the numbers below and using the passcode: 1835859

International:  +44 (0) 2071 928338
Belgium:02 793 3847
France:0805 101465
UK:0800 2796619
US:1 877 870 9135

***END***


[1] THINK – THerapeutic Immunotherapy with CAR-T NKG2D

[2] SHRINK – Standard cHemotherapy Regimen and Immunotherapy with CAR-T NKG2D

[3] LINK – Locoregional Immunotherapy with CAR-T NKG2D

[4] EPITHINK – EPIgenetic drug treatment and THerapeutic Immunotherapy with CAR-T NKG2D

[5] DEPLETHINK – LymphoDEPLEtion and THerapeutic Immunotherapy with CAR-T NKG2D

[6] Eight AML patients, one MDS (myelodysplastic syndrome) and three MM (Multiple Myeloma) patients

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Celyad announces launch of proposed global offering

May 15, 2018 By Celyad

Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of specialized CAR-T cell based therapies, today announces that it intends to offer and sell, subject to market and other conditions, up to 1,800,000 ordinary shares in a global offering, which is comprised of an offer of ordinary shares in the form of American Depositary Shares (ADSs) in the United States, Canada and certain countries outside of Europe, and an offer of ordinary shares in Europe and certain countries outside of the United States and Canada in a concurrent private placement (the “global offering”). 

Investors other than qualified investors under applicable law will not be eligible to participate in the ordinary share private placement. Each ADS offered represents the right to receive one ordinary share.

In connection with the global offering, Celyad intends to grant the underwriters a 30-day option to purchase additional ordinary shares, which may be in the form of ADSs, in an aggregate amount of up to 15% of the total number of ordinary shares (including in the form of ADSs) proposed to be sold in the global offering, on the same terms and conditions. 

The U.S. offering and the European private placement together constitutes a single offering of securities that will occur simultaneously. The total number of ordinary shares in the U.S. offering and the European private placement is subject to reallocation between them.  The closing of the global offering is subject to market and other conditions, and there can be no assurance as to whether or when the global offering may be completed or as to the actual size or terms of the global offering. The size of the global offering and the price per share of the ordinary shares and the ADSs placed in the global offering will be determined following the bookbuilding process.

Celyad’s ADSs are currently listed on the NASDAQ Global Select Market under the symbol “CYAD” and Celyad’s ordinary shares are currently listed on Euronext Brussels and Euronext Paris. Trading of Celyad’s ordinary shares will be suspended on the Euronext Brussels and Euronext Paris pending announcement of the pricing of the global offering.

Wells Fargo Securities, LLC and Bryan, Garnier & Co. are acting as joint bookrunning managers for the offering. Bank Degroof Petercam NV and LifeSci Capital LLC are acting as co-managers for the offering.  Kempen & Co NV is Celyad’s advisor in connection with the offering.

The securities are being offered pursuant to an effective shelf registration statement that was previously filed with, and declared effective by, the U.S. Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities, when available, can also be obtained for free from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, at (800) 326-5897 or email a request to cmclientsupport@wellsfargo.com; or from Bryan, Garnier & Co., Beaufort House, 15 Saint Botolph Street, London EC3A 7BB, United Kingdom, or by telephone at +44 20 7332 2500, or by email at info@bryangarnier.com.

This press release does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall there be any sale of securities in any state or jurisdiction in which such an offer, solicitation or sale is or would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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