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Celyad Oncology

Celyad Oncology Announces January 2022 Conference Schedule

December 22, 2021 By Celyad Oncology

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 January 2022:

H.C. Wainwright BioConnect 2022 Conference

Dates: Monday, January 10 to Thursday, January 13, 2022

Presentation: On-demand starting January 10, 7 a.m. ET / 1 p.m. CET

Presenter: Filippo Petti, CEO

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Press Release

Filed Under: Uncategorized

Transparency notification received from Tolefi SA and related persons (Article 14 §1 of the Law of 2 May 2007)

December 17, 2021 By Celyad Oncology

Mont-Saint-Guibert, Belgium – 17 December 2021 – 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 it has received a transparency notification dated December 17, 2021 indicating that Tolefi SA and related persons have crossed together the statutory threshold of 20%, holding 18,65% of the voting rights of the company as of 8 December 2021.

Content of the Notification:

  • Reason of the Notification:

Downward passive crossing of the 20% threshold

Downward passive crossing by persons acting in concert

  • Notification by:

Persons acting in concert

  • Persons subject to the notification requirement:

Tolefi SA, Chaussée de Waterloo 1589D, 1180 Uccle

Serge Goblet

Isabelle Thoumyre

Jérôme Goblet

Jean-Daniel Goblet

  • Transaction date

December 8, 2021

  • Threshold that is crossed (in %)

20

  • Denominator

24.961.981

  • Notified details:
A) Voting RightsPrevious notificationAfter the Transaction
 #of voting rights# of voting rights% of voting rights
Holders of voting rights Linked to the securitiesNot linked to the securitiesLinked to the securitiesNot linked to the securities
Tolefi SA4.591.4024.591.402   18,39% 
Serge Goblet56.18056.180 0,23% 
Isabelle Thoumyre7.3007.300 0,03% 
Jérôme Goblet250250 0,00% 
Jean-Daniel Goblet384384 0,00% 
TOTAL4.655.5164.655.516 18,65% 

Tolefi SA is 100% controlled by Serge Goblet, Isabelle Thoumyre, Jérôme and Jean-Daniel Goblet.

Miscellaneous

  • The Press Release may be consulted on the website of Celyad Oncology via this link.

The notification can be consulted on the website if Celyad Oncology via this link.

  • Contact person(s):

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.

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Press Release

Filed Under: Uncategorized

Celyad Oncology Announces First Patient Dosed in KEYNOTE-B79 Phase 1b Trial

December 16, 2021 By Celyad Oncology

  • KEYNOTE-B79 Phase 1b trial will evaluate CYAD-101 and KEYTRUDA® (pembrolizumab) in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC)
  • ASCO-GI conference abstract accepted that highlights KEYNOTE-B79 clinical trial design

MONT-SAINT-GUIBERT, Belgium, December 15, 2021 – 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 the first patient was dosed in the KEYNOTE-B79 Phase 1b trial (NCT04991948).

The KEYNOTE-B79 trial is part of a collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, through a subsidiary. The trial will evaluate the Company’s lead developmental candidate, its 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.

“Dosing the first patient in this Phase 1b trial represents an important step toward understanding any potential role of CYAD-101 for mCRC patients with an MSS background,” said Dr. Charles Morris, Chief Medical Officer of Celyad Oncology. “We are evaluating CYAD-101 in combination with KEYTRUDA in hope of identifying a new option to target patients’ tumors. Preclinical data and translational data from our prior phase 1 study of CYAD-101 suggest that there may be an additive benefit with pembrolizumab as an anti-PD-1 checkpoint inhibitor when combined with CYAD-101 in colorectal cancer and we look forward to studying that in the clinic. We are grateful to MSD for collaborating with us on this trial and expect to share preliminary data next year.”

The Company also reported the KEYNOTE-B79 study will be the subject of a presentation at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium being held in person in San Francisco, California and virtually from January 20-22, 2022.

ASCO GI 2022 Presentation Details:

The following abstract will be available on the ASCO GI website on January 18, 2022 at 5 p.m. EST. Following the presentation at the meeting, the poster will be available in the Scientific Publications section of Celyad Oncology’s website.

Abstract Number: TPS227

Abstract Title: KEYNOTE-B79 phase 1b trial to evaluate the allogeneic CAR T-cells CYAD-101 and pembrolizumab in refractory metastatic colorectal cancer patients.

Session Information: Trials in Progress Poster Session C: Cancers of the Colon, Rectum, and Anus

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

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Press Release

Filed Under: Uncategorized

Transparency notification received from Fortress Investment Group LLC (Article 14 §1 of the Law of 2 May 2007)

December 15, 2021 By Celyad Oncology

Mont-Saint-Guibert, Belgium – 15 December 2021 – 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 it has received a transparency notification dated December 10, 2021 indicating that CFIP CLYD LLC, an affiliate of Fortress Investment Group LLC, has crossed the statutory threshold of 25%, holding 6,500,000 shares i.e. 28.77% of Celyad Oncology’s shares and 26.04% voting rights as of 8 December 2021.

Content of the Notification:

  • Reason of the Notification:

Upward crossing of the 25% threshold

Acquisition of voting securities or voting rights

  • Notification by:

A parent undertaking or a controlling person

  • Persons subject to the notification requirement:

Fortress Investment Group LLC. – 1345 Avenue of the Americas, 46th Floor, New York, NY 10105 USA

CFIP CLYD LLC – 1345 Avenue of the Americas, 46th Floor, New York, NY 10105 USA

  • Transaction date

December 8, 2021

  • Threshold that is crossed (in %)

25

  • Denominator

22,593,956

  • Notified details:
A) Voting RightsPrevious notificationAfter the Transaction
 #of voting rights# of voting rights% of voting rights
Holders of voting rights Linked to the securitiesNot linked to the securitiesLinked to the securitiesNot linked to the securities
Fortress Investment Group LLC 0 0.00% 
CFIP CLYD LLC 6,500,000 26.04% 
Subtotal 6,500,000 26.04% 
 TOTAL6,500,000 26.04% 

Fortress Investment Group LLC indirectly controls 100% of the members of CFIP CLYD LLC, which are various Fortress Funds. Fortress Investment Group LLC has no controlling shareholder.

Miscellaneous

  • The Press Release may be consulted on the website of Celyad Oncology via this link.

The notification can be consulted on the website if Celyad Oncology via this link.

  • Contact person(s):

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.

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Communiqué de presse
Press Release

Filed Under: Uncategorized

Celyad Oncology Presents Updates on shRNA-Based CAR T Programs at the 63rd ASH Annual Meeting and Exposition

December 13, 2021 By Celyad Oncology

  • Data continues to support the versatile potential of non-gene edited shRNA technology with updates from the CYAD-02 and CYAD-211 clinical programs
  • Management to host conference call today December 13th at 2:30 p.m. CET / 8:30 a.m. EST

MONT-SAINT-GUIBERT, Belgium, December 13, 2021 – 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 data from the Phase 1 CYCLE-1 trial of CYAD-02 for the treatment of relapsed or refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) and the Phase 1 IMMUNICY-1 trial of CYAD-211 for the treatment of r/r multiple myeloma were presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition. The data support the potential and versatility of non-gene edited short hairpin RNA (shRNA) technology for the development of next-generation CAR T therapies.

“Our presentations at this year’s ASH conference continue to support the potential of our shRNA technology platform to have an impact in the CAR T space without the potential risks recently associated with gene-editing technologies,” said Dr. David Gilham, Chief Scientific Officer of Celyad Oncology. “Data from our CYAD-02 program indicate that a single shRNA can target two independent genes to optimize CAR T cell phenotype, a utility that we believe is unique among currently available gene-expression control technologies. Additionally, the initial observations of cell engraftment, lack of GvHD, and initial signs of clinical activity in the early stages of our first-in-human allogeneic CYAD-211 clinical study underpin the broad potential applicability of shRNA as a platform technology. As we continue to explore these individual product candidates and now focus upon evaluating clinical activity, this clinical proof of principle gives us high confidence to develop further novel clinical candidates based upon our novel shRNA platform.”

Filippo Petti, Chief Executive Officer of Celyad Oncology, added, “This is an exciting time for our company as we continue to validate the multifaceted approach of our shRNA technology. Continued progress with the CYAD-02 program demonstrates the power of shRNA in an autologous setting and serves as a strong foundation for any potential partnership with the program. We also have clear direction for our CYAD-211 program, where we plan to initiate enhanced lymphodepleting regimens to increase cell persistence to potentially maximize clinical benefit from the therapy. As we continue to build on our solid foundation in the allogeneic CAR T space, we remain committed to developing a new paradigm of therapy for these patients.”

Key Highlights from the ASH Annual Meeting

CYAD-02 and CYCLE-1 Phase 1 Trial Update

  • Data from autologous NKG2D receptor CAR T candidate CYAD-02 using shRNA shows a single shRNA can target two independent genes to enhance the phenotype of the CAR T cells
  • A favorable tolerability profile for CYAD-02 with a low rate of Grade ≥ 3 cytokine release syndrome in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome (r/r AML / MDS)
  • The dual knockdown of genes MICA/MICB with a single shRNA has a positive contribution to the initial clinical activity of CYAD-02 as compared to the first-generation, autologous NKG2D receptor CAR T, CYAD-01
    • Two MDS patients achieved a marrow complete response at dose level 3
    • Of the eight patients with stable disease, four had anti-leukemic activity
  • Comparison of cellular kinetics for CYAD-02 and CYAD-01 trend towards increased engraftment and persistence of CYAD-02 versus CYAD-01, potentially associated with the knockdown of MICA/MICB and reduced fratricide in vivo

CYAD-211 and IMMUNICY-1 Phase 1 Trial Update

  • Trial observations from allogeneic shRNA-based anti-BCMA CAR T candidate CYAD-211 support the continued development of shRNA-based allogeneic CAR T therapies as a feasible approach to overcome potential drawbacks and risks associated with autologous and gene-edited allogeneic CAR T therapies
  • CYAD-211 demonstrated a good tolerability profile and evidence of clinical activity in the dose-escalation segment with three out of 12 total patients with relapsed or refractory multiple myeloma (r/r MM) evaluated for activity achieving partial response, one in each dose-level, while eight patients had stable disease
  • All patients had detectable CYAD-211 cells in the peripheral blood; preconditioning chemotherapy led to earlier-than-expected recovery of host lymphocytes limiting persistence of CAR T cells
  • The next segment of the IMMUNICY-1 trial will evaluate enhanced lymphodepleting regimens with the aim to improve persistence. In addition, the protocol also allows for CYAD-211 redosing in certain patients
  • Enrollment in the cohorts evaluating enhanced lymphodepletion is ongoing. Additional data from the CYAD-211 IMMUNICY-1 trial are expected in mid-2022

Conference Call and Webcast Details

Celyad Oncology will host a conference call to discuss the update from ASH on Monday, December 13, 2021 at 2:30 p.m. CET / 8:30 a.m. EST. The conference call can be accessed through the following numbers:

United States: #1 877-407-9208

International: #1 201-493-6784

The conference call will be webcast live and can be accessed here. The event will also be archived and available on the “Events” section of the company’s website. Please visit the website several minutes prior to the start of the broadcast to ensure adequate time for registration to the webcast.

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Press Release

Filed Under: Uncategorized

Celyad Oncology Announces Closing of $32.5 Million Private Placement with Fortress Investment Group Affiliate

December 8, 2021 By Celyad Oncology

Mont-Saint-Guibert, Belgium – Celyad Oncology SA (Euronext & Nasdaq: CYAD) (“Celyad” 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, today announced the closing of its previously announced private placement with an affiliate of Fortress Investment Group (such affiliate “Fortress”). The Company issued 6,500,000 ordinary shares at a price of USD 5.00 (about EUR 4.42) for gross proceeds of USD 32.5 million (about EUR 28.7 million).

The Company intends to use net proceeds from the private placement to fund research and development expenses, including the clinical development of its allogeneic CAR T candidates CYAD-101 and CYAD-211, to advance the current pipeline of preclinical CAR T candidates, to discover and develop additional preclinical product candidates using its proprietary non-gene edited short hairpin RNA (shRNA) technology platform, as well as for working capital, other general corporate purposes, and the enhancement of the Company’s intellectual property.

SVB Leerink acted as the exclusive placement agent for the private placement, Goodwin Procter LLP and Harvest acted as legal counsel to the Company. Skadden, Arps, Slate, Meagher & Flom LLP and Eubelius acted as legal counsel to Fortress.

The securities issued in the private placement have not been registered under the Securities Act of 1933 or applicable state securities laws and may not be resold in the United States absent registration under the Securities Act or an applicable exemption from such registration requirements. The Company has agreed to customary registration rights covering the resale of the ordinary shares (in the form of American Depositary Shares) sold in the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

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