Corrections and exchanges: Celyad Oncology reports financial results for the first quarter of 2022 and recent company progress

  • In a complementary cohort of the IMMUNICY-1 dose escalation phase I trial of CYAD-211, an allogeneic shRNA-based CAR T candidate, in patients with relapsed / refractory multiple myeloma (MM r / r). Recruitment will continue.
  • Continuing dialogue with regulatory agencies regarding Phase 1 clinical trial CYAD-101-002, which is currently pending clinical trials

Belgium, Monsangibert – (Business Wire) – Regulatory News:

This press release replaces the one published at 10:01 pm on May 5th. The reasons are as follows: Updated “Financial Results for the First Quarter of 2022”.

CELYAD ONCOLOGY reports financial results for the first quarter of 2022 and recent company progress

Celyad Oncology SA (Euronext & Nasdaq: CYAD) (“Company”) is a clinical biotechnology company focused on the research and development of T cell-based chimeric antigen receptor (CAR T) cell therapies for the treatment of cancer. Announced that there is. The latest information on financial results and recent business trends for the fiscal quarter ended March 31, 2022.

“The first quarter of 2022 brought us a share of the challenges and opportunities we face. It is homologous to shRNA technology as we continue to analyze Phase 1 clinical trial CYAD-101-002. We are very pleased to announce that the program focused on the line products is on track and we are happy to announce additional data, “commented our CEO Filippo Petti. “We are deeply grateful to the team for their efforts and shareholder support to move towards our annual goal and continue to improve allogeneic CAR T therapy using our unique non-genome editing research techniques. increase.”

Updates to our clinical and preclinical programs

CYAD-211 – CAR T allogeneic, anti-BCMA, shRNA-based for the treatment of r / r MM

  • Phase 1 dose-escalation clinical trial IMMUNICY-1 provides safety and clinical activity of a single dose of CYAD-211 after preconditioning chemotherapy with cyclophosphamide and fludarabine (CyFlu) in patients with r / r MM. Is being evaluated.

    • The current segment of the IMMUNICY-1 study evaluates CYAD-211 after optimized lymphocyte depletion treatment aimed at improving cell proliferation and persistence and maximizing clinical activity of CYAD-211. doing. In addition, the IMMUNICY-1 protocol allows CYAD-211 to be redone in specific patients.

    • Recruitment for the IMMUNICY-1 trial in the eLD cohort is ongoing and additional data are expected in the second half of 2022.

CYAD-101 – TIM and NKG2D-based allogeneic CART candidates for the treatment of refractory metastatic colorectal cancer (mCRC)).

  • In February 2022, we voluntarily completed Phase 1b clinical trials evaluating CYAD-101 after the deaths of two people with similar lung lesions. Then, in March 2022, the US Food and Drug Administration notified us that the CYAD-101-002 Phase 1b trial was clinically discontinued.

  • We continued to investigate these cases in Phase 1b study CYAD-101-002 and are currently working with competent regulatory agencies to provide other potential similar in other patients treated in this study. I am evaluating the event. We look forward to providing additional information regarding clinical trials in the future.

Enhanced shRNA CART (shRNA Armored CAR) – Franchise shARC

  • Research continues through several discovery programs focused on co-expression of interleukin 18 (IL-18) and the short hairpin RNA (shRNA) technology platform (RNA). RNA) is also known as the franchise shARC (shRNA Armored CAR).

  • In April, we followed an analysis of preclinical data from several studies aimed at obtaining approval for new developments, followed by an allogeneic shRNA-based enhanced with IL-18-producing NKG2D receptors. We have decided to discontinue the development of the CART product CYAD-203. Research treatment (research that enables IND). We are leveraging our shARC platform to continue investigating allogeneic CART reserve candidates for the NKG2D receptor currently in the discovery stage.

First quarter 2022 financial results

As of March 31, 2022, our cash and cash equivalents were € 20.5 million ($ 22.9 million). Net cash burns in the first quarter of 2022 were, as expected, € 9.5 million ($ 10.6 million). We combine existing cash and cash equivalents with the remaining access to the share purchase agreement established with LPC to meet operating expense and capital spending needs based on our current scope of activity. Review previous guidance that it is sufficient to raise funds. Mid 2023.

Financial calendar

Financial results for the first half of 2022: August 5, 2022

Third Quarter 2022 Financial Results: November 10, 2022

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) -based cancer therapies for cancer. The company is developing a pipeline of allogeneic (ready-to-use) and self- (customized) CAR-T cell therapy candidates for the treatment of hematological malignancies and solid tumors. Founded in 2007, Celyad Oncology is based in Montsan Gibert, Belgium and New York, USA. The company is funded by the Wallonia region (Belgium) to support the advancement of the CAR-T cell therapy program. For more information, please visit our website.

Description of future prospects

This press release contains forward-looking statements within the meaning of applicable securities law, including the Private Securities Litigation Reform Act of 1995 (Amendment). The forward-looking statements for this release relate to, but are not limited to, the following topics: CYAD-101-002 study CYAD-101-002 study including clinical pending, timing, and supplemental data results for Phase 1 IMMUNICY-1 study of CYAD-211 Safety and clinical activity of product candidates in the Celyad Oncology pipeline, Celyad Oncology Financial position and cash business, and expected results and business outlook for the business. “May”, “Done”, “Do”, “Done”, “Should”, “Plan”, “Expect”, “Intention”, “Believe”, “Expect”, ” “Estimate”, “Future”, “Potential”, “Continuous”, “Target” and other similar words or expressions are intended to identify forward-looking statements, but all The forward-looking statement does not contain such specific words. Forward-looking statements are based on management’s current expectations, and Celyad Oncology’s actual results, financial position, performance, or performance are expressed, expressed, or implied by these forward-looking statements. It may carry known and unknown risks and uncertainties that may differ materially from what is being done. These risks and uncertainties include the timing, duration, and results of clinical discontinuation of the CYAD-101-002 Phase 1b trial, as well as Celyad Oncology’s ability to continue to access the stock purchase agreement with Lincoln Park Capital Fund LLC. However, it is not limited to these. Global economic uncertainties, including those relating to our financial and operating results, the duration and severity of the COVID-19 pandemic, and the geopolitical situation and related sanctions resulting from the conflict in Ukraine. A detailed list and description of these risks, uncertainties, and other risks can be found in Celyad Oncology’s US Securities and Exchange Commission (SEC) filings and reports, including the latest annual report. It has been. Subsequent submissions and reports of the SEC and Celyad Oncology. These forward-looking statements are stated only as of the date of this document and the actual results of Celyad Oncology may differ materially from those expressed or implied by these forward-looking statements. there is. Celyad Oncology has an obligation to update the forward-looking statements in this document to reflect changes in expectations regarding the matters discussed or changes in the events, conditions and circumstances underlying the forward-looking statements. I deny it. Unless law or regulation requires it.

contact address

Investors and Media:
Sarah Zelkovich

Communication & Investor Relations Director

Celiyad Oncology

[email protected]