CYAD Celyad Oncology SA

4.39
+0.04  (+1%)
Previous Close 4.36
Open 4.34
52 Week Low 3.76
52 Week High 10.31
Market Cap $68,095,937
Shares 15,493,956
Float 15,493,956
Enterprise Value $58,104,765
Volume 9,680
Av. Daily Volume 28,559
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Upcoming Catalysts

Drug Stage Catalyst Date
CYAD-02 CYCLE-1
Relapsed/refractory Acute myeloid leukemia (AML) and Myelodysplastic Syndrome (MDS)
Phase 1
Phase 1
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CYAD-211 ( IMMUNICY-1)
Multiple Myeloma
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
CYAD-101 - alloSHRINK
Colorectal cancer
Phase 1
Phase 1
Phase 1 preliminary data noted 2/15 partial responses from the dose-escalation segment. Median progression-free survival (mPFS) and median overall survival (mOS) was 3.9 months and 10.6 months, respectively.
CYAD-203
Solid tumors
Phase 1
Phase 1
Phase 1 IND submission expected mid-2022.
CYAD-101 and KEYTRUDA (pembrolizumab) - (KEYNOTE-B79)
Colorectal cancer
Phase 1b
Phase 1b
Phase 1b trial to be initiated 4Q 2021.
CYAD-01 and chemotherapy (DEPLETHINK)
AML or myelodysplastic syndrome (MDS)
Phase 1
Phase 1
Phase 1 data presented at ASH December 5, 2020.
CYAD-01 - THINK
Various cancers - solid and hematologic cancers
Phase 1/2
Phase 1/2
Phase 1 expansion data presented at ASH December 5, 2020. No objective responses. Development to be discontinued.
C-Cure - Chart 1 trial
Chronic Heart Failure secondary to ischemic cardiomyopathy
Phase 3
Phase 3
Phase 3 data did not meet primary endpoint

Latest News

  1. MONT-SAINT-GUIBERT, Belgium, Sept. 01, 2021 (GLOBE NEWSWIRE) -- Celyad Oncology SA ((Euronext &amp, NASDAQ:CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, today announced that the Company plans to participate at the following conferences in September 2021:

    2021 Wells Fargo Virtual Healthcare Conference
    Dates: Thursday, September 9 – Friday, September 10, 2021
    Presentation date: Thursday, September 9
    Time: 11:20 a.m. ET / 05:20 p.m. CET
    Presenter: Filippo Petti, CEO
    A webcast link will be available on the Events section of the Celyad Oncology website.

    H.C. Wainwright 23rd Annual Global Investment Conference
    Dates: Monday, September 13…

    MONT-SAINT-GUIBERT, Belgium, Sept. 01, 2021 (GLOBE NEWSWIRE) -- Celyad Oncology SA ((Euronext &, NASDAQ:CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, today announced that the Company plans to participate at the following conferences in September 2021:

    2021 Wells Fargo Virtual Healthcare Conference

    Dates: Thursday, September 9 – Friday, September 10, 2021

    Presentation date: Thursday, September 9

    Time: 11:20 a.m. ET / 05:20 p.m. CET

    Presenter: Filippo Petti, CEO

    A webcast link will be available on the Events section of the Celyad Oncology website.

    H.C. Wainwright 23rd Annual Global Investment Conference

    Dates: Monday, September 13 - Wednesday, September 15, 2021

    Presentation: On-demand starting September 13, 7 a.m. ET / 1 p.m. CET

    Presenter: Filippo Petti, CEO

    Baird's 2021 Virtual Global Healthcare Conference

    Dates: Tuesday, September 14 – Wednesday, September 15, 2021

    Presentation date: Tuesday, September 14

    Time: 3:45 p.m. ET / 9:45 p.m. CET

    Presenter: Filippo Petti, CEO

    About Celyad Oncology SA

    Celyad Oncology SA 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 expected date of the Phase 1 trial initiation by year-end 2020, our development of additional shRNA-based allogenic candidates from our CYAD-200 series towards clinical trial, and 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:
    Sara Zelkovic

    Communications & Investor Relations Director

    Celyad Oncology

    investors@celyad.com 
    Daniel Ferry

    Managing Director

    LifeSci Advisors, LLC

    daniel@lifesciadvisors.com 



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  2.  Enrollment continues at dose level three in Phase 1 IMMUNICY-1 trial evaluating CYAD-211 in relapsed/refractory multiple myeloma (r/r MM); next clinical update expected by year-end 2021
     Phase 1b KEYNOTE-B79 trial set to evaluate CYAD-101 with KEYTRUDA® in metastatic colorectal cancer (mCRC) patients with microsatellite stable disease on-track to begin in the fourth quarter of 2021
     IND-enabling studies in progress for first-in-class shRNA-based allogeneic, IL-18-armored CAR T candidate CYAD-203 for solid tumors; submission of IND application anticipated in mid-2022
     CYCLE-1 trial evaluating autologous candidate CYAD-02 in r/r AML / MDS ongoing; preliminary data from dose level three cohort showed CYAD-02 was well-tolerated with initial clinical
     Enrollment continues at dose level three in Phase 1 IMMUNICY-1 trial evaluating CYAD-211 in relapsed/refractory multiple myeloma (r/r MM); next clinical update expected by year-end 2021
     Phase 1b KEYNOTE-B79 trial set to evaluate CYAD-101 with KEYTRUDA® in metastatic colorectal cancer (mCRC) patients with microsatellite stable disease on-track to begin in the fourth quarter of 2021
     IND-enabling studies in progress for first-in-class shRNA-based allogeneic, IL-18-armored CAR T candidate CYAD-203 for solid tumors; submission of IND application anticipated in mid-2022
     CYCLE-1 trial evaluating autologous candidate CYAD-02 in r/r AML / MDS ongoing; preliminary data from dose level three cohort showed CYAD-02 was well-tolerated with initial clinical activity observed which appears greater than that previously reported from the first-generation autologous NKG2D candidate
     Conference call and webcast scheduled for tomorrow, August 5th, at 2:00 p.m. CEST / 8:00 a.m. EDT

    MONT-SAINT-GUIBERT, Belgium, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Celyad Oncology SA ((Euronext &, NASDAQ:CYAD) (the "Company"), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, today announced an update on its financial results and recent business developments for the fiscal quarter ended June 30, 2021.

    "We continue to blaze a path forward by developing new technologies to advance allogeneic CAR T therapies, including our proprietary shRNA platform for allogeneic CAR T production and ‘armored' CAR capabilities with co-expression of secreting cytokines, starting with IL-18. The innovations we are making through our clinical development pipeline and new technologies were the focus of our R&D day last month. This is an exciting time in our Company's history as we plan for a steady stream of milestones in the second half of 2021," commented Filippo Petti, Chief Executive Officer of Celyad Oncology. "We plan on announcing multiple clinical updates in the next six months that are expected to help further the progress of our lead programs and proprietary shRNA platform for the development of next-generation allogeneic CAR Ts."

    Second Quarter 2021 and Recent Business Highlights

     Dr. Charles Morris was appointed as Chief Medical Officer in April 2021.
     Preliminary data from the Phase 1 IMMUNICY-1 trial of CYAD-211 for the treatment of r/r MM were announced at the European Hematology Association (EHA) 2021 Virtual Congress.
     Research & Development Day held on July 20, 2021, during which the management team provided:
       Updates on the allogeneic CAR T clinical candidates CYAD-211 and CYAD-101.
       Highlights from the latest research from its proprietary shRNA platform, including the introduction of CYAD-203 – a novel allogeneic, IL-18-armored CAR T candidate for solid tumor now in IND-enabling studies.
       Acquisition of an exclusive license from the Moffitt Cancer Center for an antibody directed to Tumor-associated glycoprotein (TAG-72), which will form the basis of a T cell engager to be used with our shRNA platform technology.

    Pipeline Update

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

    CYAD-101 is the Company's first-in-class, allogeneic CAR T candidate engineered to co-express a chimeric antigen receptor (CAR) based on the NKG2D receptor and the novel inhibitory peptide TCR Inhibitory Molecule (TIM).

     To the Company's knowledge, CYAD-101 is the first investigational allogeneic CAR T candidate to generate evidence of clinical activity for the treatment of a solid tumor indication. This is based on data reported from the dose-escalation segment of the alloSHRINK Phase 1 trial evaluating CYAD-101 following FOLFOX (combination of 5-fluorouracil, leucovorin and oxaliplatin) preconditioning chemotherapy for the treatment of advanced metastatic colorectal cancer (mCRC).
       CYAD-101 following FOLFOX preconditioning chemotherapy was observed to be well-tolerated with no evidence of Graft-versus-Host Disease (GvHD). In addition, two of 15 patients from the dose-escalation segment of the alloSHRINK trial achieved a confirmed partial response (PR). Median progression-free survival (mPFS) and median overall survival (mOS) from the dose-escalation segment was 3.9 months and 10.6 months, respectively. In addition, tumor burden decrease based on RECIST 1.1 criteria was observed in eight of 15 patients, including six of nine patients at the recommended dose of 1×109 CYAD-101 cells per infusion.
     In September 2020, the Company entered a clinical trial collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ., USA, through a subsidiary. The Company will conduct the Phase 1b KEYNOTE-B79 clinical trial, which will evaluate CYAD-101 following FOLFOX preconditioning chemotherapy, with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in refractory mCRC patients with microsatellite stable (MSS) / mismatch-repair proficient (pMMR) disease. Initiation of the KEYNOTE-B79 trial is expected in the fourth quarter of 2021.

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

    CYAD-211 is an investigational, shRNA-based allogeneic CAR T candidate for the treatment r/r MM. CYAD-211 is engineered to co-express a B cell maturation antigen (BCMA) targeting CAR and a single shRNA, which interferes with the expression of the CD3ζ component of the T-cell receptor (TCR) complex.

     The Company recently announced preliminary data from the dose-escalation Phase 1 IMMUNICY-1 trial, evaluating the tolerability and clinical activity of a single infusion of CYAD-211 following preconditioning with cyclophosphamide (300 mg/m²) and fludarabine (30 mg/m²) given for three consecutive days.
       In June 2021, preliminary data from the Phase 1 IMMUNICY-1 trial was presented at the EHA congress that demonstrated no dose limiting toxicity (DLT), Graft-versus-Host disease (GvHD) or CAR T-cell-related encephalopathy syndrome (CRES) were observed in the first two dose levels (30×106 and 100×106 cells per infusion) of the trial. Two of the five evaluable patients at the first two dose levels achieved a partial response. In addition, CYAD-211 cells were detected by PCR-based methods in all six patients with evidence of a dose dependent increase in cell engraftment.
       In July 2021, the Company reported data from the first patient at dose level three (300×106 cells per infusion) which continues to show dose dependent engraftment of CYAD-211 with no GvHD reported to date.
     Enrollment in the trial is ongoing with plans to explore higher doses of preconditioning regimens in future cohorts.

    CYAD-203 – Allogeneic shRNA-based, IL-18-armored NKG2D CAR T for Solid Tumors

    CYAD-203 is the Company's first armored CAR T candidate engineered to co-express the cytokine interleukin-18 (IL-18) with the NKG2D CAR receptor. To the Company's knowledge, this therapy is on track to be the first IL-18 secreting allogeneic CAR T candidate. IL-18 is a proinflammatory cytokine that directly potentiates the anti-cancer activity of CAR T cells while also altering the balance of pro- and anti-inflammatory cells within tumor tissue.

     Investigational New Drug (IND)-enabling studies are currently in-progress for the program. Submission of the IND application for CYAD-203 for treatment of solid tumors is expected in mid-2022.

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

    CYAD-02, the Company's autologous CAR T candidate with shRNA technology that targets the NKG2D ligands MICA and MICB, is currently being evaluated for the treatment of r/r acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in the Phase 1 CYCLE-1 dose-escalation trial.

     To date, eleven patients have received treatment with CYAD-02 in the CYCLE-1 trial, with an enrollment of five patients at dose level three (1×109 cells per infusion).
       Preliminary data from the dose level three cohort demonstrated that CYAD-02 was generally well-tolerated. One dose-limiting toxicity was reported at dose level three (cytokine release syndrome, grade 4), leading to expansion of that cohort to six patients. In addition, initial clinical activity has been observed which appears greater than that previously reported from the first-generation autologous NKG2D candidate consistent with a positive contribution from the shRNA-mediated reduction in MICA/B production.
     Dose level three cohort of the CYCLE-1 trial is ongoing. Additional safety and efficacy data from the trial are expected by year-end 2021.

    Upcoming Anticipated Milestones

     Initiation of Phase 1b KEYNOTE-B79 trial evaluating CYAD-101 with KEYTRUDA® for advanced mCRC patients with MSS / pMMR disease in fourth quarter of 2021.
     Report additional data for the Phase 1 IMMUNICY-1 trial of CYAD-211 for r/r MM by year-end 2021.
     Submission of an IND application for CYAD-203 for solid tumors in mid-2022.
     Report additional data from the dose-escalation Phase 1 CYCLE-1 trial evaluating CYAD-02 in r/r AML and MDS by year-end 2021.

    First Half 2021 Financial Results

    Key financial figures for the first half of 2021, compared with the first half of 2020 and full year 2020, are summarized below:

    Selected key financial figures (€ millions)Half Year

    30 June 2021
    Half Year

    30 June 2020
    Full Year

    31 December 2020
    Revenue- - -
    Research and development expenses (10.0) (11.1) (21.5)
    General and administrative expenses (4.8) (4.8) (9.3)
    Change in fair value of contingent consideration (2.0) (2.4)9.2
    Other income/(expenses) 1.8 1.8 4.6
    Operating loss (14.9) (16.6) (17.0)
    Loss for the period/year (14.9) (16.6) (17.2)
    Net cash used in operations (12.2) (14.6) (27.7)
    Cash and cash equivalents 12.0 26.7 17.2

    Research and Development expenses were €10.0 million for the first half of 2021, compared to €11.1 million for the first half of 2020. The €1.1 million decrease was mainly driven by lower preclinical expenses, including process development, as well as decreased clinical costs associated with the autologous r/r AML and MDS franchise.

    General and Administrative expenses were €4.8 million for the first half of 2021, compared to €4.8 million for the first half of 2020. An increase in insurance costs for the period were compensated by savings on travel and living expenses due to COVID-19 pandemic travel restrictions and a decrease in expenses associated with the share-based payments related to the Company's warrants plan.

    A fair value adjustment of €2.0 million (non-cash expense) related to the reassessment of the contingent consideration and other financial liabilities associated with the advancement in the Company's NKG2D-based CAR T candidates as of June 30, 2021 required by International Financial Reporting Standards (IFRS) was mainly driven by time accretion as well as updated assumptions to discount rate and revaluation of the U.S. dollar foreign exchange rate.

    The Company also posted €1.8 million in net other income for the first half of 2021, compared to a net other income of €1.8 million for the first half of 2020. Other income for the first half of 2021 is primarily due to grant income from the Walloon Region and from the Federal Belgian Institute for Health Insurance (Inami) of €1.6 million.

    Net loss for the first half of 2021 was €14.9 million, or € (1.02) per share, compared to a net loss of €16.6 million, or €(1.19) per share, for the first half of 2020.

    Net cash used in operations, which excludes non-cash expenses, was €12.2 million for the first half of 2021, compared to €14.6 million for the first half of 2020.

    As of June 30, 2021, the Company had cash and cash equivalents of €12.0 million ($14.3 million). During the first half of 2021, the Company raised proceeds of €8.1 million ($9.7 million) from the sale of American Depositary Shares (ADSs), in aggregate, to Lincoln Park Capital Fund, LLC (LPC) and through its At-the-Market facility. The Company believes that its existing cash and cash equivalents combined with the remaining access to the equity purchase agreement established with LPC should be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements to the end of the third quarter of 2022.

    As of June 30, 2021, the total number of basic shares outstanding were 15.494 million, as compared to 13.942 million as of June 30, 2020.

    Celyad Oncology First Half 2021 Conference Call Details

    Date: Thursday, August 5, 2021

    Time: 2 p.m. CEST / 8 a.m. EDT

    Dial-in: +1 412 317 6060 (International), + 1 866 652 5200 (United States) or +32 (0) 800 389 13 (Belgium)

    Please ask to be joined into the Celyad Oncology SA call

    The conference call will be webcast live and archived within the "Events" section of the Celyad Oncology website.

    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 include statements regarding the clinical activity and safety and tolerability of CYAD-211, CYAD-203, CYAD-101 and CYAD-02; expectations regarding enrollment and the announcement of additional clinical data; outcomes and timelines for the IMMUNICY-1 and CYCLE-1 clinical trials and plans for initiating KEYNOTE-B79 Phase 1b trial; the timeline for submission an IND application for CYAD-203; and the Company's cash runway. 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 include 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 24, 2021, 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:

    Sara Zelkovic

    Communications & Investor Relations Director

    Celyad Oncology

    investors@celyad.com

    Daniel Ferry

    Managing Director

    LifeSci Advisors, LLC

    daniel@lifesciadvisors.com

    Source: Celyad Oncology SA



    Celyad Oncology SA

    Interim Consolidated Statement of Comprehensive Income (Unaudited)

    (€'000)For the Six-month periodFor the Six-month period
     ended June 30,ended June 30,
     20212020
    Revenue -   5  
    Cost of sales- - 
    Gross profit -   5  
    Research and Development expenses(9 956)(11 141)
    General & Administrative expenses(4 785)(4 789)
    Change in fair value of contingent consideration                                 (1 961)(2 445)
    Other income1 987 2 026 
    Other expenses(162)(211)
    Operating Loss (14 877) (16 555)
    Financial income166 112 
    Financial expenses(143)(154)
    Loss before taxes (14 854) (16 597)
    Income taxes- - 
    Loss for the period (14 854) (16 597)
    Basic and diluted loss per share (in €)                                   (1.02)(1.19)
    Other comprehensive income/(loss)  
    Items that will not be reclassified to profit and loss                          -   -  
    Remeasurement of post-employment benefit obligations, net of tax                                          - - 
    Items that may be subsequently reclassified to profit or loss                           14   7  
    Currency translation differences14 7 
    Other comprehensive income / (loss) for the period, net of tax                                         14 7 
    Total comprehensive loss for the period                  (14 840) (16 590)
    Total comprehensive loss for the period attributable to Equity Holders                   (14 840) (16 590)



    Celyad Oncology SA

    Interim Consolidated Statement of Financial Position (Unaudited)

    (€'000)June 30,December 31,
     20212020
    NON-CURRENT ASSETS 46 094   46 379  
    Goodwill and Intangible assets36 127 36 171 
    Property, Plant and Equipment3 592 4 119 
    Non-current Trade and Other receivables          2 135 2 117 
    Non-current Grant receivables4 002 3 679 
    Other non-current assets238 293 
    CURRENT ASSETS 16 594   19 705  
    Trade and Other Receivables712 615 
    Current Grant receivables1 912 145 
    Other current assets1 953 1 711 
    Short-term investments- - 
    Cash and cash equivalents12 017 17 234 
    TOTAL ASSETS 62 688   66 084  
    EQUITY 24 861   30 994  
    Share Capital53 913 48 513 
    Share premium2 217 43 349 
    Other reserves32 062 30 958 
    Accumulated deficit(63 331)(91 826)
    NON-CURRENT LIABILITIES 25 290   23 256  
    Bank loans- - 
    Lease liabilities2 104 2 525 
    Recoverable Cash advances (RCAs)4 935 4 220 
    Contingent consideration payable and other financial liabilities             17 487 15 526 
    Post-employment benefits614 614 
    Other non-current liabilities150 371 
    CURRENT LIABILITIES 12 537   11 834  
    Bank loans- 37 
    Lease liabilities977 1 076 
    Recoverable Cash advances (RCAs)340 371 
    Trade payables5 582 4 736 
    Other current liabilities5 638 5 614 
    TOTAL EQUITY AND LIABILITIES 62 688   66 084  

     

     



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  3. MONT-SAINT-GUIBERT, Belgium, July 30, 2021 (GLOBE NEWSWIRE) -- Celyad Oncology SA ((Euronext &amp, NASDAQ:CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, announced on July 30, 2021, a capital increase of 300,000 new shares of the Company to Lincoln Park Capital Fund, LLC ("LPC"), a Chicago-based institutional investor. As a result, the Company's share capital is increased to 54,956,224.33 EUR and is represented by 15,793,956 shares.

    This information is published in accordance with Article 15 of the Belgian Law of 2 May 2007 on the disclosure of major participations in issuers whose shares are admitted to trading on a regulated market and…

    MONT-SAINT-GUIBERT, Belgium, July 30, 2021 (GLOBE NEWSWIRE) -- Celyad Oncology SA ((Euronext &, NASDAQ:CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, announced on July 30, 2021, a capital increase of 300,000 new shares of the Company to Lincoln Park Capital Fund, LLC ("LPC"), a Chicago-based institutional investor. As a result, the Company's share capital is increased to 54,956,224.33 EUR and is represented by 15,793,956 shares.

    This information is published in accordance with Article 15 of the Belgian Law of 2 May 2007 on the disclosure of major participations in issuers whose shares are admitted to trading on a regulated market and regarding miscellaneous provisions.

    Figures – Modified on 30 July 2021 following the Capital Increase:

    Total amount of share capital (EUR)54,956,224.33
    Total Number of shares with single voting rights13,425,931
    Total Number of shares with double voting rights2,368,025
    Total Number of Shares15,793,956
    Total of voting rights18,161,981
    Total number of attributed warrants1,922,423
    Total number of shares with voting rights that could be created following the exercise of the attributed warrants1,922,423
    Total number of diluted shares (Outstanding shares + Warrants)17,716,379
    Total number of diluted shares with voting rights20,084,404

    Contact person for regulated information (financial, transparency)

    By law, any transparency declaration must be sent to our Company by email to the attention of Filippo Petti, Chief Executive Officer (CEO): investors@celyad.com.

    Further questions about the content of this release can be sent to investors@celyad.com.

    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 include statements regarding the clinical activity and safety and tolerability of CYAD-211, CYAD-203, and CYAD-101; expectations regarding enrollment and the announcement of additional clinical data; outcomes and timelines of the IMMUNICY-1 clinical trial and plans for initiating KEYNOTE-B79 Phase 1b trial; and the timeline for submission an IND application for CYAD-203. 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 include 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 24, 2021 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

    Sara Zelkovic

    Communications & Investor Relations Director

    Celyad Oncology

    investors@celyad.com

    Daniel Ferry

    Managing Director

    LifeSci Advisors, LLC

    daniel@lifesciadvisors.com

    Source: Celyad Oncology SA



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  4. MONT-SAINT-GUIBERT, Belgium, July 29, 2021 (GLOBE NEWSWIRE) -- Celyad Oncology SA ((Euronext &amp, NASDAQ:CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, today announced that the Company will report first half 2021 financial and operating results on the evening of Wednesday, August 4, 2021.

    Following the press release, Celyad management will host a conference call on Thursday, August 5 at 2 p.m. CEST / 8 a.m. EDT to discuss first half 2021 results and provide an update on the Company's recent progress and upcoming milestones.

    Participants may access the conference call by dialing +1 412 317 6060 (International), +1 866 652 5200 (United…

    MONT-SAINT-GUIBERT, Belgium, July 29, 2021 (GLOBE NEWSWIRE) -- Celyad Oncology SA ((Euronext &, NASDAQ:CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, today announced that the Company will report first half 2021 financial and operating results on the evening of Wednesday, August 4, 2021.

    Following the press release, Celyad management will host a conference call on Thursday, August 5 at 2 p.m. CEST / 8 a.m. EDT to discuss first half 2021 results and provide an update on the Company's recent progress and upcoming milestones.

    Participants may access the conference call by dialing +1 412 317 6060 (International), +1 866 652 5200 (United States) or +32 (0) 800 389 13 (Belgium), and ask to be joined into the Celyad Oncology SA call.

    To access the live webcast and archived recording, visit the "Events" section of the Celyad website.

    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 include statements regarding the clinical activity and safety and tolerability of CYAD-211, CYAD-203, and CYAD-101; expectations regarding enrollment and the announcement of additional clinical data; outcomes and timelines of the IMMUNICY-1 clinical trial and plans for initiating KEYNOTE-B79 Phase 1b trial; and the timeline for submission an IND application for CYAD-203. 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 include 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 24, 2021 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:

    Sara Zelkovic

    Communications & Investor Relations Director

    Celyad Oncology

    investors@celyad.com

    Daniel Ferry

    Managing Director

    LifeSci Advisors, LLC

    daniel@lifesciadvisors.com

    Source: Celyad Oncology SA



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    • Phase 1 IMMUNICY-1 trial evaluating CYAD-211 in relapsed/refractory multiple myeloma (r/r MM) showed dose dependent engraftment up to dose level three (300×106 cells per infusion) with no Graft-versus-Host disease reported to date
    • Submission of IND application for CYAD-203, a new first-in-class shRNA-based allogeneic, IL-18-armored CAR T candidate, expected in mid-2022
    • CYAD-101 following FOLFIRI preconditioning in advanced metastatic colorectal cancer (mCRC) was well-tolerated; cell kinetic and activity of alloSHRINK trial support the initiation of the KEYNOTE-B79 Phase 1b trial of CYAD-101 following FOLFOX preconditioning chemotherapy during early fourth quarter 2021

    MONT-SAINT-GUIBERT, Belgium, July 20, 2021 (GLOBE NEWSWIRE) -- Celyad Oncology…

    • Phase 1 IMMUNICY-1 trial evaluating CYAD-211 in relapsed/refractory multiple myeloma (r/r MM) showed dose dependent engraftment up to dose level three (300×106 cells per infusion) with no Graft-versus-Host disease reported to date
    • Submission of IND application for CYAD-203, a new first-in-class shRNA-based allogeneic, IL-18-armored CAR T candidate, expected in mid-2022
    • CYAD-101 following FOLFIRI preconditioning in advanced metastatic colorectal cancer (mCRC) was well-tolerated; cell kinetic and activity of alloSHRINK trial support the initiation of the KEYNOTE-B79 Phase 1b trial of CYAD-101 following FOLFOX preconditioning chemotherapy during early fourth quarter 2021

    MONT-SAINT-GUIBERT, Belgium, July 20, 2021 (GLOBE NEWSWIRE) -- Celyad Oncology SA ((Euronext &, NASDAQ:CYAD) (Celyad Oncology or the Company), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, highlighted a new preclinical allogeneic armored CAR T candidate developed from its shRNA platform and data updates to the shRNA-based allogeneic candidate CYAD-211 for r/r MM and allogeneic candidate CYAD-101 for mCRC today during a research and development day hosted by the Company's management team.

    "We are ushering in a new era of allogeneic CAR T candidates using novel technological advances, including our proprietary shRNA platform for allogeneic CAR T production and now the addition of our 'armored' CAR capabilities with co-expression of the cytokine IL-18," said Filippo Petti, Chief Executive Officer of Celyad Oncology. "We believe the advances we're making may address many of the current modality limitations and have the potential to provide real-world benefits for patients, including more accessible CAR T cell treatment options, if approved. This continued technological innovation, which is currently being validated in ongoing clinical studies, establishes Celyad Oncology as a leader in this adoptive cell therapy space."

    Latest Program Updates

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

    • CYAD-211 is the Company's first shRNA-based allogeneic CAR T candidate, which co-expresses a BCMA targeting chimeric antigen receptor while using shRNA to knockdown expression of the CD3ζ component of the T-cell receptor (TCR)
      • Currently, CYAD-211 is being evaluated in the Phase 1 IMMUNICY-1 trial in r/r MM following preconditioning with cyclophosphamide (300 mg/m²) and fludarabine (30 mg/m²) given three consecutive days.
      • In June, preliminary data from the Phase 1 IMMUNICY-1 trial was presented at the European Hematology Association (EHA) congress demonstrating no dose limiting toxicity (DLT), Graft-versus-Host disease (GvHD) or CAR T-cell-related encephalopathy syndrome (CRES) in the first two dose levels (30×106 and 100×106 cells per infusion) of the trial. Two of the five evaluable patients at the first two dose levels achieved a partial response. In addition, CYAD-211 cells were detected by PCR-based methods in all six patients with evidence of a dose dependent increase in cell engraftment.
    • Recent data from the first patient at dose level three (300×106 cells per infusion) continues to show dose dependent engraftment with no GvHD reported to date.
    • Enrollment in the trial is ongoing with plans to explore higher doses of preconditioning regimens in future cohorts.

    CYAD-203 – Allogeneic shRNA-based, IL-18-armored NKG2D CAR T for Solid Tumors

    • CYAD-203 is the Company's first armored CAR T candidate engineered to co-express the cytokine interleukin-18 (IL-18) with the NKG2D CAR receptor. To the Company's knowledge, this therapy is on track to be first ever IL-18 secreting allogeneic CAR T candidate.
      • IL-18 is a proinflammatory cytokine that directly potentiates the anti-cancer activity of CAR T cells while also altering the balance of pro- and anti-inflammatory cells within tumor tissue.
      • Investigational New Drug (IND)-enabling studies are currently ongoing. Submission of the IND application for CYAD-203 for treatment of solid tumors is expected in mid-2022.

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

    • To the Company's knowledge, CYAD-101 is the first investigational allogeneic CAR T candidate to generate evidence of clinical activity for the treatment of a solid tumor indication. This is based on data from the dose-escalation segment of the alloSHRINK Phase 1 trial evaluating CYAD-101 following FOLFOX (combination of 5-fluorouracil, leucovorin and oxaliplatin) preconditioning chemotherapy for the treatment of advanced metastatic colorectal cancer (mCRC).
    • Initial data from the dose expansion cohort evaluating CYAD-101 (1×109 cells per infusion) following FOLFIRI (combination of 5-fluorouracil, leucovorin and irinotecan) preconditioning chemotherapy showed CYAD-101 was generally well-tolerated with no dose limiting toxicities or evidence of GvHD. Overall, nine out of ten evaluable mCRC patients showed stable disease at first tumor assessment.
    • Data also showed shorter persistence of CYAD-101 cells observed after FOLFIRI preconditioning as compared to FOLFOX preconditioning. Based on better CYAD-101 cell kinetics and clinical activity data from the alloSHRINK FOLFOX cohort, the Company submitted a protocol amendment to regulatory agencies to modify the Phase 1b KEYNOTE-B79 trial to incorporate FOLFOX as preconditioning chemotherapy.
      • The KEYNOTE-B79 trial to evaluate CYAD-101 with Merck's anti-PD­1 therapy, KEYTRUDA® (pembrolizumab), in refractory mCRC patients with microsatellite stable / mismatch-repair proficient disease is expected to be initiated during the fourth quarter of 2021.

    Business Update

    • Celyad Oncology has acquired an exclusive license from the Moffitt Cancer Center for an antibody directed to Tumor-associated glycoprotein (TAG-72), which will form the basis of a T cell engager to be used with our proprietary shRNA platform technology. TAG-72 has been shown to be expressed in a wide variety of epithelial malignant tissues including breast, colon and pancreatic cells and will expand the Company's program portfolio in solid tumor targets.

    Upcoming Milestones

    • Additional clinical activity data for the Phase 1 IMMUNICY-1 trial of CYAD-211 for r/r MM are expected during second half 2021.
    • Study initiation for KEYNOTE-B79 Phase 1b is expected early fourth quarter 2021.
    • Submission of an IND application for CYAD-203 is expected in mid-2022.
    • Report additional data from the dose-escalation Phase 1 CYCLE-1 trial evaluating CYAD-02 in relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome in mid-2021.

    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 include statements regarding the clinical activity and safety and tolerability of CYAD-211, CYAD-203, and CYAD-101; expectations regarding enrollment and the announcement of additional clinical data; outcomes and timelines of the IMMUNICY-1 clinical trial and plans for initiating KEYNOTE-B79 Phase 1b trial; and the timeline for submission an IND application for CYAD-203. 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 include 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 24, 2021 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: 
      
    Sara ZelkovicDaniel Ferry

    Communications & Investor Relations DirectorManaging Director

    Celyad Oncology LifeSci Advisors, LLC

    investors@celyad.comdaniel@lifesciadvisors.com

    Source: Celyad Oncology SA

     



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