Uncategorized

Gosselies and Mont-Saint-Guibert, Belgium – Cellistic, the cell therapy development and manufacturing  business of Ncardia BV, and Celyad Oncology (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 today a transaction whereby Cellistic will acquire Celyad Oncology’s Good Manufacturing Practice (GMP) grade cell therapy manufacturing capability, including the existing facility and all related personnel (the “Manufacturing Business Unit”).

Under the terms of an asset purchase agreement between Celyad Oncology and Cellistic, Cellistic agreed to acquire Celyad Oncology’s Manufacturing Business Unit in Mont-Saint-Guibert, Belgium, for a total consideration of €6 million. Celyad Oncology’s experienced manufacturing team will join Cellistic. The transaction is subject to a number of customary conditions precedent and is anticipated to close in the fourth quarter of this year.

“We at Cellistic are incredibly excited to welcome this uniquely talented team into our organization,” said Stefan Braam, founder and CEO of Cellistic. “We’re bringing aboard a group of people whose passion and capabilities align incredibly well with our vision for the future of cell therapy. As a joined force, we have the talent and resources to further accelerate work on our proprietary platforms and the capability to enable Cellistic’s partners to bring iPSC-based allogeneic cell therapies to patients faster.”

Michel Lussier, co-founder and interim CEO of Celyad Oncology, said, “We have focused our efforts on an allogeneic approach for the past few years and our manufacturing facility and staff has been a key element to enable many of our past trials, but has been underutilized in recent years as we mainly used the facility for our autologous candidates. Our current allogeneic programs are better suited for outsourced manufacturing. Through existing materials manufactured at Celyad, we have ensured the means to continue our clinical programs with cryopreserved cells until 2024. Based on this strategy, we are confident that this decision to transfer our manufacturing facility and the staff to Cellistic, who is the perfect company for such an agreement, will allow us to further execute on our business goals in the future.”

Cellistic will invest substantial capital into the newly acquired 11,000 square foot facility, which will be optimized for its iPSC-based allogeneic cell therapy platforms and processes creating the world’s first purpose built facility to support customers from cell reprogramming and master cell banking through clinical trial material manufacturing. A team of more than 30 manufacturing, quality and related personnel from Celyad Oncology, all with substantial cell therapy manufacturing and immune-oncology experience, will join Cellistic as part of this transaction.

Celyad Oncology will provide additional guidance on the future business strategy of the Company in the fourth quarter of this year.

• Enrollment ongoing in Phase 1 dose-escalation IMMUNICY-1 trial for lead shRNA-based allogeneic CAR T candidate, CYAD-211, for relapsed/refractory (r/r) multiple myeloma (MM)
• In July 2022, the U.S. Food and Drug Administration (FDA) lifted the clinical hold for the T-cell-inhibitory-molecule (TIM)-based allogeneic CAR T candidate CYAD-101 for metastatic colorectal cancer (mCRC)
• Company to increase strategic focus on collaborations related to broad intellectual property portfolio
• Conference call and webcast scheduled for today, August 5^th, at 2:00 p.m. CEST / 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 an update on its financial results and recent business developments for the first half ended June 30, 2022.

“As the Company continues to evolve, we are excited about a renewed focus on additional value drivers for Celyad Oncology. Importantly, with our world-class intellectual property focused on allogeneic CAR T technology, we have multiple opportunities for partnerships with peers in the industry,” commented Michel Lussier, interim Chief Executive Officer of Celyad Oncology. “We also were proud to recently announce that the FDA lifted the clinical hold on our CYAD-101 program. In addition, we look forward to the upcoming data read out for CYAD-211 in the second half of 2022. We are truly ushering in a new chapter for Celyad Oncology by unlocking the potential of not only our product candidates, but also our portfolio of IP, technology, and overall expertise in cell therapy.” 

Second Quarter 2022 and Recent Business Highlights

• The Board of Directors named Hilde Windels as Chair of the Board of Directors
• Michel Lussier named Interim Chief Executive Officer of the Company

Pipeline and Business Updates

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

CYAD-211 is an investigational, short hairpin RNA (shRNA)-based allogeneic CAR T candidate for the treatment of 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.

• Preliminary data reported in December 2021 from the dose-escalation segment of the IMMUNICY-1 Phase 1 trial evaluating CYAD-211 following cyclophosphamide/fludarabine (CyFlu) preconditioning chemotherapy in patients with r/r MM showed evidence of clinical activity with a good tolerability profile including no evidence of Graft versus Host Disease. In addition, all patients in the trial had detectable CYAD-211 cells in the peripheral blood.
• Enrollment is currently ongoing in the IMMUNICY-1 Phase 1 trial to evaluate enhanced lymphodepletion (eLD) and increased CYAD-211 doses with the aim to improve cell persistence and potentially maximize the clinical benefit of CYAD-211. The IMMUNICY-1 protocol also allows for CYAD-211 redosing in certain patients.
• Additional data updates from the eLD cohorts of the Phase 1 IMMUNICY-1 trial of CYAD-211 for r/r MM are expected during second half of 2022.

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

CYAD-101 is an investigational, non-gene edited, allogeneic CAR T candidate engineered to co-expresses the TIM peptide alongside a CAR based on NKG2D, a receptor expressed on natural killer (NK) and T cells, that binds to eight stress-induced ligands.

• In June 2022 we submitted our complete response to the clinical hold of the CYAD-101-002 phase 1b trial to the FDA stating our intent to amend the eligibility criteria to exclude patients who have bilateral lung metastases and patients who have received treatment with epidermal growth factor receptor (EGFR) targeting monoclonal antibodies within the previous 9 months prior to trial recruitment. In July 2022, based on that complete response, we received notification that the FDA lifted the clinical hold on the CYAD-101-002 phase 1b trial

shARC Platform

Discovery research continues on programs focused on the co-expression of Interleukin-18 in conjunction with our short hairpin RNA shRNA technology platform, also known as our shARC (shRNA Armored CAR) franchise, with a focus on the development of next-generation, allogeneic CAR T candidates.

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

CYAD-02 is an investigational, autologous CAR T therapy that co-expresses both the NKG2D CAR and a single shRNA targeting the NKG2D ligands MICA/MICB on the CAR T cells.

• In December 2021, the Company presented clinical results from the dose-escalation CYCLE-1 Phase 1 trial evaluating CYAD-02 for the treatment of r/r acute myeloid leukemia (AML) and myelodysplastic syndromes (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 showed a positive contribution to the initial clinical activity of CYAD-02 as well as a trend towards increased engraftment and persistence compared to the first-generation, autologous NKG2D receptor CAR T.
• The Company continues to explore potential partnership opportunities for the future development of CYAD-02.

Strategic Focus on Intellectual Property

The Company maintains a robust intellectual property portfolio within the landscape of CAR T, including twelve foundational U.S.

patents associated with allogeneic CAR T for the treatment of cancer as well as patents for NKG2D receptor-based cell therapies. We believe these patents provide an avenue for the Company to develop its own programs as well as to seek potential partnership opportunities.  

First Half 2022 Financial Results

Key financial figures for the first half of 2022, compared with the first half of 2021 and full year 2021, are summarized below:

Selected key financial figures (€ millions)	Half Year 30 June 2022	Half Year 30 June 2021	Full Year 31 December 2021
Revenue	–	–	–
Research and development expenses	(10.5)	(10.0)	(20.8)
General and administrative expenses	(6.2)	(4.8)	(9.9)
Change in fair value of contingent consideration	1.1	(2.0)	0.8
Other income/(expenses)	1.6	1.8	3.4
Operating loss	(14.1)	(14.9)	(26.4)
Loss for the period/year	(14.1)	(14.9)	(26.5)
Net cash used in operations	(16.3)	(12.2)	(26.6)
Cash and cash equivalents	14.4	12.0	30.0

Research and Development expenses were €10.5 million for the first half of 2022, compared to €10.0 million for the first half of 2021. The €0.5 million increase was mainly driven by intellectual property filing and maintenance fees to strengthen intellectual property prosecution and the increase of employee expenses mainly related to the full expense impact of the employees recruited during 2021 to support the Group’s preclinical and clinical programs, employee turnover and management changes, both of which were partially offset by the decrease in clinical activities resulting from the Phase 1b CYAD-101-002 (KEYNOTE-B79) trial which was on clinical hold during the second quarter of 2022.

General and Administrative expenses were €6.2 million for the first half of 2022, compared to €4.8 million for the first half of 2021. This increase is primarily attributable to an increase in insurance costs for the period, combined with an increase in employee expenses mainly related to management changes through the six-month period ended June 30, 2022.

A fair value adjustment of €1.1 million (non-cash income) related to the reassessment of the contingent consideration and other financial liabilities associated with the advancement of the Company’s NKG2D-based CAR T candidates as of June 30, 2022, required by International Financial Reporting Standards (IFRS), was mainly driven by the updated assumptions on projected revenue associated with the Company’s CYAD-101 program, for which the timing of the potential commercialization has been delayed by one year. Additionally, the addressable patient population for CYAD-101 has been reduced based on recent safety findings from the CYAD-101-002 Phase 1b trial. The fair value adjustment was also driven by updated assumptions to discount rate and revaluation of the U.S. dollar foreign exchange rate.

The Company also posted €1.6 million in net other income for the first half of 2022, compared to a net other income of €1.8 million for the first half of 2021. Other income for the first half of 2022 is primarily due to grant income from the Walloon Region of €1.4 million.

Net loss for the first half of 2022 was €14.1 million, or € (0.62) per share, compared to a net loss of €14.9 million, or € (1.02) per share, for the first half of 2021.

Net cash used in operations was €16.3 million for the first half of 2022, compared to €12.2 million for the first half of 2021.

As of June 30, 2022, the Company had cash and cash equivalents of €14.4 million ($15.0 million).

As of June 30, 2022, the total number of basic shares outstanding were 22.6 million similar to December 31, 2021.

Celyad Oncology First Half 2022 Conference Call Details

Date: Friday, August 5, 2022

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

Dial-in: +1 201 493 6779 (International), + 1 877 407 9716 (United States) or +32 (0) 800 73 904 (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.

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 U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the CYAD-101-002 (KEYNOTE-B79) Phase 1b trial after the Company made changes to the eligibility criteria for the trial.

“We are pleased that the FDA lifted the clinical hold on this trial. We remain confident in the potential development of not only the candidate itself, but the continued development with our proprietary TIM technology. CYAD-101 is currently our only clinical candidate co-expressing NKG2D and TIM, and we hope to continue to showcase our expertise with our non-gene edited technologies and explore additional opportunities to utilize NKG2D in allogeneic CAR T,” said Dr. Charles Morris, Chief Medical Officer of Celyad Oncology.

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. The trial was subsequently put on clinical hold in March 2022 by the FDA.

The CYAD-101-002 Phase 1b trial evaluates 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.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. 

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 will report first half 2022 financial and operating results on the morning of Friday, August 5, 2022.

Following the press release, Celyad Oncology management will host a conference call that day Friday, August 5 at 2 p.m. CEST / 8 a.m. EDT to discuss first half 2022 results and provide an update on the Company’s recent progress and upcoming milestones.

Participants may access the conference call by dialing +1 201 493 6779 (International), + 1 877 407 9716 (United States) or +32 (0) 800 73 904 (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 Oncology website.

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 the Board of Directors has named Hilde Windels as Chairwoman of the Board of Directors, effective immediately. Ms. Windels has been a member of the Board of Directors since May 2018. Ms. Windels serves on multiple boards in the life sciences industry and has been an executive in the sector from 1999 through 2021, serving primarily as Chief Financial Officer and, over the last five years, as Chief Executive Officer. Ms. Windels succeeds Michel Lussier who has been named Interim Chief Executive Officer of the Company, effective immediately. Mr. Lussier is a co-founder of the Company and has been a member of the Board of Directors since 2007. Mr. Lussier succeeds Filippo Petti who has resigned as Chief Executive Officer, Chief Financial Officer and member of the Board of Directors to pursue other opportunities. Mr. Petti will serve as a consultant to the Company through July 31, 2022 to ensure an effective transition while the Board of Directors commences a search for a permanent Chief Executive Officer.

“I would like to thank Filippo for his significant contribution to Celyad Oncology. Under his leadership, the Company has become a key player in the CAR T cell therapy landscape, providing a strong foundation on which Celyad Oncology can enter its next strategic phase,” commented Michel Lussier, Interim Chief Executive Officer.

Hilde Windels, Chairwoman of the Board of Directors added, “On behalf of the Board of Directors, I would like to express our gratitude for Filippo’s dedication and efforts. We wish him all the success in his future endeavors as we look forward to continuing the execution of Celyad Oncology’s strategy of building a dynamic biotechnology company in the field of allogeneic CAR T.”

Mont-Saint-Guibert, Belgium – Celyad Oncology SA (Euronext & Nasdaq: CYAD) (the “Company”), a clinical-stage biotechnology company focused on the discovery and the development of Chimeric Antigen Receptor T cell (CAR T) therapies for cancer, announced that 350 registered shares benefit from a double voting right as of May 25, 2022. As a result, the Company’s total number of voting rights is now 24,962,331.

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 25 May 2022 following the Double Voting Rights:

Total amount of share capital (EUR)	78,584,224.33
Total Number of shares with single voting rights	20,225,581
Total Number of shares with double voting rights	2,368,375
Total Number of Shares	22,593,956
Total of voting rights	24,962,331
Total number of attributed warrants	1,997,190
Total number of shares with voting rights that could be created following the exercise of the attributed warrants	1,997,190
Total number of diluted shares (Outstanding shares + Warrants)	24,591,146
Total number of diluted shares with voting rights	26,959,521

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.