Uncategorized

Dear Shareholder,

Over 2021, the hard work and dedication of the entire Celyad Oncology team has helped us to continue to make steady progress advancing our mission to develop next-generation allogeneic CAR T candidates that offer new therapeutic options to cancer patients with poor prognosis. Our development pipeline has continued to transition to an allogeneic strategy centered around

i) our single-step engineering, All-in-One vector approach and

ii) our proprietary non-gene edited technologies including short hairpin RNA (shRNA) and T cell receptor Inhibitory Molecule (TIM).

Throughout the past twelve months, we’ve announced encouraging clinical data from our programs at major scientific conferences and further built our position as a leader in the field of allogeneic CAR T cell therapies.

• Phase 1 IMMUNICY-1 trial demonstrated encouraging data to date for CYAD-211 including a good tolerability profile and evidence of clinical activity in relapsed/refractory multiple myeloma (r/r MM) patients
• Investigation ongoing of findings in CYAD-101-002 Phase 1b trial following announcement of clinical hold by FDA
• Cash position of €30.0 million ($34.0 million) as of December 31, 2021
• Conference call and webcast scheduled for March 25 at 1:00 p.m. CET / 8:00 a.m. EDT

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 its financial results for the fiscal year 2021 ended December 31, 2021 and provided a business update.

“This is a transformative time for Celyad Oncology as we work towards becoming a leading innovator in the allogeneic CAR T space. Over the past year, our team executed in evaluating our dynamic shRNA proprietary technology platform and introduced our armored CAR T franchise while delivering important updates across our CAR T pipeline. In addition, we expect our recently announced private placement with Fortress Investment Group to act as a catalyst for our corporate initiatives to advance our intellectual property and allogeneic CAR T product candidates,” commented Filippo Petti, Chief Executive Officer of the Company. “Although we are facing a current challenge with the CYAD-101 Phase 1b trial, the safety of our patients is our first priority, and we are focusing our efforts on the current investigation. The situation does not take away from the important work our team is doing and we believe we can look forward to announcing exciting upcoming milestones in 2022.”

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 r/r MM.
  • At the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition in December 2021, the Company presented the latest clinical data from the trial that showed a good tolerability profile and evidence of clinical activity. Data showed no dose-limiting toxicities, GvHD or CAR T-related encephalopathy syndrome (CRES). There was one Grade 1 cytokine release syndrome (CRS) event and three patients experienced Grade 3 or 4 treatment-related blood disorders. Three out of 12 total patients with r/r MM evaluated for activity achieved partial response, one in each dose-level, while eight patients had stable disease. All patients had detectable CYAD-211 cells in the peripheral blood, although engraftment was short lasting.
  • The next segment of the IMMUNICY-1 study will evaluate 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 is ongoing with additional data expected in the second half of 2022.

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

• In December 2021, the Company announced the first patient was dosed in the Phase 1b CYAD-101-002 (KEYNOTE-B79) Phase 1b trial. The CYAD-101-002 trial is part of a collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, through a subsidiary. The trial is evaluating the Company’s TCR Inhibitory Molecule (TIM)-based allogeneic NKG2D CAR T cell investigational therapy, CYAD-101, administered concurrently with FOLFOX chemotherapy, followed by MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with refractory mCRC with microsatellite stable/mismatch-repair proficient disease.
• In February 2022, the Company voluntarily placed the Phase 1b trial on clinical hold after two fatalities occurred that presented with similar pulmonary findings. Subsequently, in March 2022, the U.S. Food & Drug Administration (FDA) put the Company on a clinical hold. The Company is currently investigating these findings and evaluating any similar events in additional patients treated on study. The Company expects to provide additional updates on the trial in the future.
• CYAD-101 is the only investigational candidate from the Company using the TIM technology.

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

• Preclinical data presented at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting demonstrated enhanced anti-tumor activity of NKG2D CAR T cells when armored with the cytokine Interleukin-18 (IL-18), supporting the continued development of CYAD-203 as well as future allogeneic IL-18-armored CAR T candidates.
• IND-enabling studies are currently in progress alongside production of the clinical grade vector. Submission of the IND application to the FDA for CYAD-203 is anticipated by year-end 2022.

CYAD-02 – Autologous NKG2D receptor CAR T Candidate for relapsed or refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome (r/r AML / MDS)

• At the ASH Annual Meeting and Exposition in December 2021, the Company presented the latest clinical data from the Phase 1 CYCLE-1 dose-escalation trial of CYAD-02 for the treatment of r/r AML / MDS.
  • Data from the trial showed that a single shRNA can target two independent genes (MICA/MICB) to enhance the phenotype of the CAR T cells. In addition, the dual knockdown of these genes showed a positive contribution to the initial clinical activity of CYAD-02 as well as a trend towards increased engraftment and persistence compared to our first-generation, autologous NKG2D receptor CAR T candidate, CYAD-01. A comparison of cellular kinetics for CYAD-02 and CYAD-01 trend towards increased engraftment and persistence of CYAD-02, potentially associated with the knockdown of MICA/MICB and reduced fratricide in vivo.

Upcoming Anticipated Milestones

• Enrollment in the cohorts evaluating enhanced lymphodepletion is ongoing in the CYAD-211 IMMUNICY-1 trial and additional data from the trial are expected in the second half of 2022.
• IND-enabling studies continue for CYAD-203, with submission of an IND application to the FDA for CYAD-203 anticipated by year-end 2022.

Full Year 2021 Financial Review

As of December 31, 2021, the Company had cash and cash equivalents of €30.0 million ($34.0 million).

Based on the Company’s current scope of activities, the Company estimates that its cash and cash equivalents as of December 31, 2021, 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.

Key financial figures for full-year 2021, compared with full-year 2020, are summarized below:

Selected key financial figures (€ millions)	Full year 2021	Full year 2020
Revenue	–	–
Research and development expenses	(20.8)	(21.5)
General and administrative expenses	(9.9)	(9.3)
Change in fair value of contingent consideration	0.8	9.2
Other income/(expenses)	3.4	4.6
Operating loss	(26.4)	(17.0)
Loss for the period/year	(26.5)	(17.2)
Net cash used in operations	(26.6)	(27.7)
Treasury position(1)	30.0	17.2

⁽¹⁾ “Treasury position” is an alternative performance measure determined by adding Short-term investments and Cash and cash equivalents from the statement of financial position prepared in accordance with IFRS. The purpose of this measure by Management is to identify the level of cash available internally (excluding external sources of financing) within 12 months.

The Company’s license and collaboration agreements generated no revenue in 2021 and in 2020.

Research and Development (R&D) expenses were €20.8 million in 2021 as compared to €21.5 million in 2020,  a year-over-year decrease of €0.7 million. The decrease in the Company’s R&D expenses is primarily driven by the Company’s decision to discontinue the development of CYAD-01 in the fourth quarter of 2020, as well as a decrease of the expenses associated with share-based payments (non-cash expenses) related to the warrant plan offered to our employees and directors.

General and Administrative (G&A) expenses were €9.9 million in 2021 as compared to €9.3 million in 2020, an increase of €0.6 million. This increase is primarily related to higher insurances costs and consulting fees partially compensated by the decrease of the expenses associated with the share-based payments (non-cash expenses) related to the warrants plan offered to our employees and directors.

The fair value adjustment (€0.8 million) relating to the contingent consideration and other financial liabilities as of December 31, 2021 was mainly driven by updated assumptions associated with the timing of the potential commercialization of the Company’s allogenic CYAD-101 CAR T program for mCRC and autologous CYAD-02 CAR T program for r/r AML/MDS as well as to reflect the future development of the program through potential partnership. The decrease of the liability is also driven by an update to the fair value measurement based on factors such as the weighted average cost of capital, the revaluation of the U.S. dollar against the Euro and updated assumptions on probability of success associated with the Company’s CAR T programs as of December 31, 2021.

The Company’s other income is associated with grants received from the Walloon Region mainly in the form of recoverable cash advances (RCAs) and R&D tax credit income:

• Grant income (RCAs): additional grant income has been recognized in 2021 on grants in the form of RCAs. According to IFRS standards, the Company has recognized grant income for the period amounting to €2.7 million and a liability component of €1.6 million is accounted for as a financial liability.
• Grant income (Others): additional grant income has been recognized in 2021 on grants received from the Federal Belgian Institute for Health Insurance Inami (€0.3 million) and from the regional government (for €1.1 million), not referring to RCAs and not subject to reimbursement.
• With respect to R&D tax credit, the current year income is predicated on a R&D tax credit recorded as (€0.7 million), which has been updated to take into account all information available as of this date and is in line with previous year.

In 2021, other income was partially compensated by other expenses including the remeasurement income on the RCAs of €0.3 million for the year 2021 and amendment fees associated with the Dartmouth license agreement signed in December 2021 for €1.1 million.

Net loss for the year ended December 31, 2021 was €26.5 million, or €1.70 per share, compared to a net loss of €17.2 million, or €1.23 per share, for the same period in 2020. As noted above, the increase in net loss between periods was primarily due to the decrease change in fair value of contingent consideration combined with the decrease on other income/expenses.

Net cash used in operations for the year ended December 31, 2021, which excludes non-cash effects, amounted to €26.6 million, which is in line with net cash used in operations of €27.7 million for the year ended December 31, 2020.

Annual Report 2021

The Annual Report for the year ended December 31, 2021 will be published on March 24, 2022, and will be available on the Company’s website, www.celyad.com. The Company’s statutory auditor, EY Bedrijfsrevisoren BV/Réviseurs d’Entreprises SRL (EY), has confirmed that the completed audit has not revealed any material misstatement in the consolidated financial statements. EY also confirmed that the accounting data reported in the press release are consistent, in all material respects, with the consolidated financial statements from which it has been derived.

Conference Call and Webcast Details

A conference call will be held on Friday, March 25^th at 1:00 p.m. CET / 8:00 a.m. EDT to review the financial and operating results for Full Year 2021. Please dial into the call five to ten minutes prior to start time using the appropriate number below and ask to join the “Celyad Oncology SA call”:

• United States: + 1 866 652 5200
• Belgium: +32 (0) 800 389 13
• International: +1 412 317 6060

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

Financial Calendar

Q1 2022 Financial Results             May 5, 2022

H1 2022 Financial Results             August 5, 2022

Q3 2022 Financial Results             November 10, 2022

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 that on March 1, 2022, the Company was informed via e-mail communication from the U.S. Food and Drug Administration that the CYAD-101-002 (KEYNOTE-B79) Phase 1b trial has been placed on clinical hold due to insufficient information to assess risk to study subjects. As previously disclosed, on February 28, 2022, the Company announced that it was voluntarily pausing the CYAD-101-002 trial to investigate reports of two fatalities in the study.

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 it has taken the decision to voluntarily pause the CYAD-101-002 (KEYNOTE-B79) Phase 1b trial (NCT04991948).

The CYAD-101-002 trial is part of a collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, through a subsidiary. The trial is evaluating the Company’s TCR Inhibitory Molecule (TIM)-based allogeneic NKG2D CAR T cell investigational therapy CYAD-101 administered concurrently with FOLFOX chemotherapy, followed by MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with refractory metastatic colorectal cancer.

The Company has received reports of two fatalities that presented with similar pulmonary findings. With a clear focus on patient safety and an overriding sense of caution, the Company has decided to voluntarily pause dosing and enrollment of patients in the CYAD-101-002 trial in order to investigate these events. The Company is currently investigating these reports and evaluating any similar events in additional patients treated on study. The Company is informing regulatory agencies, which may require additional actions of the Company. The Company expects to provide additional updates on the trial in the near future.

“Our primary commitment is to maintain patient safety, which is why we decided to place the trial on hold while we investigate these events,” said Filippo Petti, Chief Executive Officer of Celyad Oncology. “We are working diligently to better understand these events. In twenty-five patients previously treated with CYAD-101 in the alloSHRINK Phase 1 trial, which evaluated the TIM-based investigational candidate for the treatment of advanced mCRC, no-dose limiting toxicities were reported. Lastly, we anticipate no impact on our shRNA-based candidates, including CYAD-211 currently under investigation for the treatment of multiple myeloma.”  

Mont-Saint-Guibert, Belgium – 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 virtually in the following conference in February 2022:

Virtual 11th Annual SVB Leerink Global Healthcare Conference 2022

Dates: Monday, February 14 to Friday, February 18, 2022

Presentation: February 18, 8 a.m. ET / 2 p.m. CET

Presenter: Filippo Petti, CEO

Webcast: A live and archived webcast of the presentation will be available in the Events section of the Celyad Oncology website.

• KEYNOTE-B79 and IMMUNICY-1 clinical trials evaluating the Company’s allogeneic CAR T candidates, CYAD-101 and CYAD-211 respectively, expected to generate key data throughout 2022
• Company’s proprietary non-gene edited shRNA technology clinically validated as a novel platform for the development of next-generation, allogeneic CAR Ts
• Preclinical shRNA-based allogeneic pipeline continues to progress with IL-18-armored CAR T candidate CYAD-203 as well as discovery programs focused on in-licensed T-cell engagers targeting TAG72 and GPC3
• Recent $32.5 million private placement with Fortress Investment Group affiliate to fund further research and development of Company’s current allogeneic CAR T pipeline

MONT-SAINT-GUIBERT, Belgium, January 10, 2022 – 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 a 2021 year-end review and provided an outlook for 2022.

Filippo Petti, Chief Executive Officer of Celyad Oncology, said, “Our clinical development team has continued to deliver a steady stream of data across multiple programs throughout 2021 that advanced our position as a leader in the field of allogeneic CAR T cell therapies. Singlehandedly, the validation of our proprietary shRNA platform this past year represented an incredible achievement for the Company as we continued to strategically transform the organization to a fully allogeneic CAR T platform Company. The power and versatility of our shRNA platform, including the ability to multiplex and modulate the levels of gene expression, continues to support its strength, value, and potential differentiation within the allogenic cell therapy landscape. We believe our non-gene edited technologies are well-positioned to drive a major impact on the CAR T industry as the approach that does not have the risks associated with gene-editing technologies, including the potential for translocation adverse events.”

“Our leading clinical CAR T assets, novel shRNA platform and foundational intellectual property within the allogeneic landscape has attracted widespread industry attention including most recently from Fortress Investment Group, which invested $32.5 million into the Company. We believe our cutting-edge research in the allogeneic CAR T field supported by clinical data presented at multiple medical conferences over the past year and combined with these broader resources place us on an accelerated path towards developing the therapeutic benefit of our extensive set of technologies. This is an exciting time at Celyad Oncology and we look forward to building upon our recent accomplishments throughout 2022 and beyond,” concluded Mr. Petti.

2021 Business Highlights

• Dosed first patient in KEYNOTE-B79 Phase 1b trial (NCT04991948), which will evaluate the TCR Inhibitory Molecule (TIM)-based allogeneic NKG2D CAR T cell investigational therapy CYAD-101 with MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with refractory metastatic colorectal cancer (mCRC) with microsatellite stable (MSS) / mismatch-repair proficient disease
• Data from the dose-escalation segment of the IMMUNICY-1 Phase 1 trial (NCT04613557) evaluating the allogeneic shRNA-based anti-BCMA CAR T candidate CYAD-211 in patients with relapsed or refractory multiple myeloma (r/r MM) showed evidence of clinical activity with a good tolerability profile including no evidence of Graft versus Host Disease (GvHD). In addition, all patients in trial had detectable CYAD-211 cells in the peripheral blood
• Research & Development Day in July showcased the Company’s current pipeline of allogeneic CAR T programs and shRNA-based preclinical concepts while also introducing CYAD-203 – an allogeneic shRNA-based interleukin-18 (IL-18)-armored NKG2D CAR T candidate
• Presented clinical results from the CYCLE-1 Phase 1 trial (NCT04167696) evaluating the next-generation, autologous NKG2D receptor CAR T candidate CYAD-02. Data from the study showed that a single shRNA can target two independent genes (MICA/MICB) to enhance the phenotype of the CAR T cells – a differentiated approach among currently available gene-expression control technologies
• Bolstered balance sheet with $32.5 million private placement with an affiliate of Fortress Investment Group. The Company believes its existing cash and cash equivalents combined with access to the equity purchase agreement established with Lincoln Park Capital Fund, LLC should be sufficient to fund operating expenses and capital expenditure requirements into the first half of 2023

Program Update and Anticipated Milestones for 2022

• Following the dose-escalation segment of the IMMUNICY-1 Phase 1 trial for CYAD-211, the next segment of the study will evaluate enhanced lymphodepleting regimens with the aim to improve cell persistence and potentially maximize the clinical benefit of the anti-BCMA CAR T candidate. The IMMUNICY-1 protocol also allows for CYAD-211 redosing in certain patients. Enrollment in the cohorts evaluating enhanced lymphodepletion is ongoing and additional data from the CYAD-211 IMMUNICY-1 trial are expected in mid-2022
• Enrollment continues in the KEYNOTE-B79 Phase 1b trial for CYAD-101. Preliminary data from the trial are expected in the second half of 2022
  • In addition, the KEYNOTE-B79 study will be the subject of a presentation at the upcoming American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) Symposium being held from January 20-22, 2022
• Investigational New Drug (IND)-enabling studies continue for CYAD-203. Submission of the IND application for CYAD-203 is expected in the second half of 2022