UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the Month of May 2022

Commission File Number: 001-37452

 

 

CELYAD ONCOLOGY SA

(Translation of registrant’s name into English)

 

 

Rue Edouard Belin 2

1435 Mont-Saint-Guibert, Belgium

(Address of principal executive offices)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F K  ☒            Form 40-F  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  ☐

 

 

 


Celyad Oncology SA

Financial and Operating Results

On May 5, 2022, Celyad Oncology SA (the “Company”) issued a press release announcing its financial and operating results for the first quarter of 2022. A copy of the Company’s press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. The Company’s interim consolidated statement of comprehensive income and interim consolidated statement of financial position for the first quarter of 2022 are attached hereto as Exhibit 99.2 and are incorporated herein by reference.

The information contained in this Current Report on Form 6-K, including Exhibits 99.1 and 99.2, except for the quote of Filippo Petti contained in Exhibit 99.1, is hereby incorporated by reference into the Company’s Registration Statements on Forms F-3 (File No. 333-248464) and S-8 (File No. 333-220737).


EXHIBITS

 

Exhibit

  

Description

99.1    Press release issued by the registrant on May 5, 2022
99.2    Interim consolidated statement of comprehensive income and interim consolidated statement of financial position


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

    CELYAD ONCOLOGY SA
Date: May 6, 2022     By:  

/s/ Filippo Petti

      Filippo Petti
      Chief Executive Officer and Financial Officer

Exhibit 99.1

Regulated Information

May 5th, 2022 4:01 PM ET

 

LOGO

Celyad Oncology Announces First Quarter 2022 Financial Results and Recent Business Highlights

 

   

Enrollment continues in Phase 1 dose-escalation IMMUNICY-1 trial for lead shRNA-based allogeneic CAR T candidate, CYAD-211, for relapsed/refractory multiple myeloma (r/r MM)

 

   

Dialogue continues with regulatory agencies concerning CYAD-101-002 Phase 1b trial, which remains on clinical hold

Mont-Saint-Guibert, Belgium – 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 March 31, 2022.

“The first quarter of 2022 brought us both challenges and opportunities that we are facing head-on. While we continue to investigate the recent developments in the CYAD-101 Phase 1b trial, we are making great progress with our shRNA-based allogeneic programs, including CYAD-211, for which we anticipate announcing additional data during the second half of the year,” commented Filippo Petti, Chief Executive Officer of the Company. “We are truly thankful for our hardworking team and the support of our shareholders while we advance towards our milestones for the year and further enhance our allogeneic CAR T investigational therapies with our proprietary non gene edited technologies.”

Update on Clinical and Preclinical Programs

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

 

   

The dose-escalation Phase 1 IMMUNICY-1 trial is evaluating the tolerability and clinical activity of a single infusion of CYAD-211 following preconditioning with CyFlu (cyclophosphamide and fludarabine) in patients with relapsed / refractory multiple myeloma (r/r MM).

   

The current segment of the IMMUNICY-1 study is evaluating CYAD-211 following enhanced lymphodepleting (eLD) regimens with the aim to improve cell expansion and persistence and potentially maximize the clinical activity of CYAD-211. In addition, the IMMUNICY-1 protocol allows for redosing of CYAD-211 in certain patients.

 

   

Enrollment in the eLD cohorts of the IMMUNICY-1 trial continues with additional data expected from the program in the second half of 2022.

CYAD-101 – Allogeneic TIM-based, NKG2D CAR T Candidate for Metastatic Colorectal Cancer (mCRC)

 

   

In February 2022, the Company voluntarily paused the Phase 1b trial of CYAD-101 after two fatalities occurred that presented with similar pulmonary findings. Subsequently, in March 2022, the Company was informed by the U.S. Food and Drug Administration that the CYAD-101-002 Phase 1b trial had been placed on clinical hold.

 

   

The Company continues to investigate these findings in the CYAD-101-002 Phase 1b trial and is evaluating any similar events in additional patients treated in the study, while also working with appropriate regulatory authorities. The Company expects to provide additional updates on the trial in the future.

shRNA Armored CAR (shARC) Franchise

 

   

Research continues in multiple discovery programs focused on the co-expression of Interleukin-18 (IL-18) in conjunction with our short hairpin RNA (shRNA) technology platform, also known as our shARC (shRNA Armored CAR) franchise.

 

   

In April, the Company decided to stop the development of CYAD-203, an allogeneic shRNA-based, IL-18-armored NKG2D CAR T candidate following the analysis of preclinical data from multiple investigational new drug application (IND)-enabling studies. The Company continues to explore back-up allogeneic NKG2D receptor CAR T candidates currently in discovery stage that leverage the Company’s shARC platform.

 

LOGO

Celyad Oncology SA | Rue Édouard Belin 2, 1435 Mont-Saint-Guibert, Belgium | +32 10 39 41 00


First Quarter 2022 Financial Review

As of March 31, 2022, the Company had cash and cash equivalents of €20.5 million ($22.9 million). Net cash burn during the first quarter of 2022 amounted to €9.5 million ($10.6 million), in line with expectations. The Company confirms its previous guidance that its existing cash and cash equivalents, combined with the remaining access to the equity purchase agreement established with Lincoln Park Capital Fund, LLC, should be sufficient to fund operating expenses and capital expenditure requirements until mid-2023.

Financial Calendar

 

First Half 2022 Financial Results    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) 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 statements

This release contains forward-looking statements, within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, without limitation, statements regarding: the CYAD-101-002 trial, including the clinical hold, the timing and outcomes of additional data from Phase 1 IMMUNICY-1 trial of CYAD-211, safety and clinical activity of the product candidates in Celyad Oncology’s pipeline, Celyad Oncology’s financial condition and cash runway, and expected results of operations and business outlook. The words “may,” “might,” “will,” “could,” “would,” “should,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “future,” “potential,” “continue,” “target” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements are based on management’s current expectations and 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, without limitation: the timing, duration and outcome of the clinical hold on the CYAD-101-002 Phase 1b trial, Celyad Oncology’s ability to continue to access to the equity purchase agreement with Lincoln Park Capital Fund, LLC, our financial and operating results, the duration and severity of the COVID-19 pandemic, and global economic uncertainty, including with respect to geopolitical conditions and attendant sanctions resulting from the conflict in Ukraine. 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 the latest Annual Report on Form 20-F filed with the SEC, and subsequent filings and reports of 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 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 Contact:

 

Sara Zelkovic    Celyad Oncology
Communications & Investor Relations Director    investors@celyad.com

Exhibit 99.2

Celyad Oncology SA

Unaudited interim consolidated statement of comprehensive income

 

(€‘000)    For the three-month period
ended March 31,
 
     2022     2021  

Revenue

     —         —    

Cost of sales

     —         —    

Gross profit

     —         —    

Research and Development expenses

     (4.978     (4 739

General & Administrative expenses

     (2.750     (2 341 )

Change in fair value of contingent consideration

     (55     (2 220

Other income

     1.123       670  

Other expenses

     (888     (145

Operating Loss1

     (7.549     (8 774

Financial income

     39       140  

Financial expenses

     (63     (66

Loss before taxes

     (7.573     (8 701

Income taxes

     —         —    

Loss for the period

     (7.573     (8 701

Basic and diluted loss per share (in €)

     (0.34     (0.61
  

 

 

   

 

 

 

Other comprehensive income/(loss)

    

Items that will not be reclassified to profit and loss

     —         —    

Remeasurements of post-employment benefit obligations, net of tax

     —         —    

Items that may be subsequently reclassified to profit or loss

     (16     8  

Currency translation differences

     (16     8  

Other comprehensive income / (loss) for the period, net of tax

     (16     8  
  

 

 

   

 

 

 

Total comprehensive loss for the period

     (7.589     (8 693

Total comprehensive loss for the period attributable to Equity Holders

     (7.589     (8 693
  

 

 

   

 

 

 

 

1 

The operating loss arises from the Company’s loss for the period before deduction of Financial income, Financial expenses and Income taxes. The purpose of this measure by Management is to identify the Company’s results in connection with its operating activities.


Celyad Oncology SA

Unaudited interim consolidated statement of financial position

 

(€’000)    March 31,
2022
    December 31,
2021
 

NON-CURRENT ASSETS

     43.129       45 651  

Goodwill and intangible assets

     35.967       36 168  

Property, Plant and Equipment

     3.008       3 248  

Non-current Trade and Other receivables

     —         2 209  

Non-current Grant receivables

     3.935       3 764  

Other non-current assets

     219       262  

CURRENT ASSETS

     26.088       34 292  

Trade and Other Receivables

     933       668  

Current Grant receivables

     2.413       1 395  

Other current assets

     2.230       2 211  

Short-term investments

     —         —    

Cash and cash equivalents

     20.512       30 018  
  

 

 

   

 

 

 

TOTAL ASSETS

     69.217       79 943  
  

 

 

   

 

 

 

EQUITY

     36.493       43 639  

Share Capital

     78.585       78 585  

Share premium

     6.317       6 317  

Other reserves

     33.599       33 172  

Capital reduction reserve

     234.562       234 562  

Accumulated deficit

     (316.570     (308 997

NON-CURRENT LIABILITIES

     22.595       22 477  

Bank loans

     —         —    

Lease liabilities

     1.555       1 730  

Recoverable Cash advances (RCAs)

     6.087       5 851  

Contingent consideration payable and other financial liabilities

     14.733       14 679  

Post-employment benefits

     53       53  

Other non-current liabilities

     167       164  

CURRENT LIABILITIES

     10.129       13 827  

Bank loans

     —         —    

Lease liabilities

     841       902  

Recoverable Cash advances (RCAs)

     343       362  

Trade payables

     5.510       6 611  

Other current liabilities

     3.435       5 952  
  

 

 

   

 

 

 

TOTAL EQUITY AND LIABILITIES

     69.217       79 943